Annex ACTIVE · Commission Implementing Regulation (EU) No 540/2011

Contents

PART B — Active substances approved under Regulation (EC) No 1107/2009

—for the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009 in relation to each substance, the conclusions of the review report on it, and in particular the Appendices I and II thereof, shall be taken into account;

—Member States shall keep available all review reports (except for confidential information within the meaning of Article 63 of Regulation (EC) No 1107/2009) for consultation by any interested parties or shall make it available to them on specific request.

General provisions applying to all substances listed in this Part:

Number	Common Name, Identification Numbers	IUPAC Name	Purity^note	Date of approval	Expiration of approval	Specific provisions

1	BispyribacCAS No125401-75-4CIPAC No748	2,6-bis(4,6-dimethoxypyrimidin-2-yloxy)benzoic acid	≥ 930 g/kg (referred to as bispyribac-sodium)	1 August 2011	31 July 2022	PART AOnly uses as herbicide in rice may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bispyribac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment, Member States shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of authorisation shall include risk mitigation measures where appropriate.The Member States concerned shall request the submission of further information as regards the possible groundwater contamination by metabolites M03^note, M04^note and M10^note.They shall ensure that the applicant provides such information to the Commission by 31 July 2013.
2	ProfoxydimCAS No 139001-49-3CIPAC No 621	2 - [(1 E/Z) - [(2 R S) – 2 - (4 – chlorophenoxy) propoxyimino] butyl] – 3 – hydroxy – 5 - [(3 R S; 3 S R) – tetrahydro – 2 H – thiopyran – 3 – yl] cyclohex – 2 - enone	≥ 940 g/kg	1 August 2011	31 July 2021	PART AOnly uses as herbicide in rice may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on profoxydim, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment, Member States shall pay particular attention to:the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions,the long-term risk to non-target organisms.Conditions of authorisation shall include risk mitigation measures where appropriate.
3	AzimsulfuronCAS No 120162-55-2CIPAC No 584	1-(4,6-dimethoxypyrimidin-2-yl)-3-[1-methyl-4-(2-methyl-2H-tetrazol-5-yl)-pyrazol-5-ylsulfonyl]-urea	≥ 980 g/kgmaximum level of the impurity phenol 2 g/kg	1 January 2012	31 December 2021	PART AOnly uses as herbicide may be authorised.Aerial applications may not be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on azimsulfuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(1) the protection of non-target plants;(2) the potential for groundwater contamination, when the active substance is applied in vulnerable scenarios and/or climatic conditions;(3) the protection of aquatic organisms.Member States shall ensure that the conditions of authorisation include risk mitigation measures, where appropriate (e.g. buffer zones, in rice cultivation minimum holding periods for water prior to discharge).The notifier shall submit confirmatory information as regards:(a) the risk assessment on aquatic organisms;(b) the identification of the degradation products in the aqueous photolysis of the substance.The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.
4	AzoxystrobinCAS No 131860-33-8CIPAC No 571	methyl (E)-2-{2[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate	≥ 930 g/kgToluene maximum content 2 g/kgZ-isomer maximum content 25 g/kg	1 January 2012	31 May 2027	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on azoxystrobin and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(1) the fact that the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material;(2) the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;(3) the protection of aquatic organisms.The Member States must ensure that the conditions of authorisation include risk mitigation measures, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards the risk assessment on groundwater and aquatic organisms.The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.
5	ImazalilCAS No 35554-44-073790-28-0 (replaced)CIPAC No 335	(RS)-1-(β-allyloxy-2,4-dichlorophenethyl)imidazoleorallyl (RS)-1-(2,4-dichlorophenyl)-2-imidazol-1-ylethyl ether	≥ 950 g/kg	1 January 2012	31 May 2027	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on imazalil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall:(1) pay particular attention to the fact that the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material;(2) pay particular attention to the acute dietary exposure situation of consumers in view of future revisions of maximum residue levels;(3) pay particular attention to the operators and workers safety. Authorised conditions of use must prescribe the application of adequate personal protective equipment and risk mitigation measures to reduce the exposure;(4) ensure that appropriate waste management practices to handle the waste solution remaining after application, such as the cleaning water of the drenching system and the discharge of the processing waste are put in place. Prevention of any accidental spillage of treatment solution. Member States permitting the release of waste water into the sewage system shall ensure that a local risk assessment is carried out;(5) pay particular attention to risk to aquatic organisms and soil micro-organisms and long-term risk to granivorous birds and mammals.Conditions of authorisation shall include risk mitigation measures, where appropriate.The notifier shall submit confirmatory information as regards:(a) route of degradation of imazalil in soil and surface water systems;(b) environmental data to support the managing measures that Member States have to put in place to ensure that groundwater exposure is negligible;(c) a hydrolysis study to investigate the nature of residues in processed commodities.The notifier shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.
6	ProhexadioneCAS No 127277-53-6 (prohexadione-calcium)CIPAC No 567 (prohexadione)No 567.020 (prohexadione-calcium)	3,5-dioxo-4-propionylcyclohexanecarboxylic acid	≥ 890 g/kg(expressed as prohexadione-calcium)	1 January 2012	15 May 2028	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prohexadione and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.
7	SpiroxamineCAS No 1181134-30-8CIPAC No 572	8-tert-butyl-1,4-dioxaspiro[4.5]decan-2-ylmethyl(ethyl)(propyl)amine (ISO)	≥ 940 g/kg(diastereomers A and B combined)	1 January 2012	30 November 2029	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on spiroxamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(1) the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment;(2) the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;(3) the risk to aquatic organisms.Conditions of authorisation shall include risk mitigation measures, where appropriate.The notifier shall submit confirmatory information as regards:(a) the possible impact on the worker, the consumer and the environmental risk assessment of the potential stereo-selective degradation of each isomer in plant, animals and the environment;(b) the toxicity of the plant metabolites formed in fruit crops and the potential hydrolysis of fruit crop residues in processed commodities;(c) the groundwater exposure assessment for metabolite M03;(d) the risk to aquatic organisms.The notifier shall submit to the Member States, the Commission and the Authority the information set out in point (a) by two years after the adoption of specific guidance and the information set out in points (b), (c) and (d) by 31 December 2013.
8	Kresoxim-methylCAS No 143 390-89-0CIPAC No 568	methyl (E)-methoxyimino[a-(o-tolyloxy)-o-tolyl]acetate	≥ 910 g/kgMethanol: max. 5 g/kgMethyl chloride: max. 1 g/kgToluene: max. 1 g/kg	1 January 2012	31 May 2027	PART AOnly uses as fungicide may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on kresoxim-methyl and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account.Member States shall pay particular attention to the protection of groundwater under vulnerable conditions; the conditions of authorisation shall include, where appropriate, risk mitigation measures.The applicant shall submit confirmatory information as regards:Groundwater exposure risk assessment, and in particular:on the lysimeter study to support the statement that the two unidentified peaks observed do not correspond to metabolites individually exceeding the trigger value of 0,1 μg/L,on the recovery of metabolite BF 490-5 in order to confirm its absence in the lysimeter leachate at levels exceeding 0,1 μg/L,on a groundwater exposure risk assessment for the late application in apples, pears and grapes.The applicant shall submit to the Member States, the Commission and the Authority such information by 31 December 2013.
9	FluroxypyrCAS No 69377-81-7CIPAC No 431	4-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetic acid	≥ 950 g/kg (fluroxypyr-meptyl)The following manufacturing impurity is of toxicological concern and must not exceed the following amount in the technical material:N-methyl-2-pyrrolidone (NMP): < 3 g/kg	1 January 2012	15 February 2027	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluroxypyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 23 March 2017 shall be taken into account.In this overall assessment, Member States must pay particular attention to:the potential contamination of groundwater by metabolite fluroxypyr pyridinol, when the active substance is applied in regions with alkaline or vulnerable soil or with vulnerable climatic conditions;the risk to aquatic organisms.Conditions of authorisation shall include risk mitigation measures, where appropriate.
10	TefluthrinCAS No: 79538-32-2CIPAC No: 451	2,3,5,6-tetrafluoro-4-methylbenzyl (1RS, 3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylateTefluthrin is a 1:1 mixture of Z-(1R, 3R) and Z-(1S, 3S) enantiomers.	≥ 920 g/kgHexachlorobenzene: not more than 1 mg/kg	1 January 2012	31 May 2027	PART AOnly uses as insecticide may be authorised.The seed coating shall only be performed in professional seed treatment facilities. These facilities shall apply the best available techniques in order to exclude the release of dust clouds during storage, transport and application.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tefluthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the operators and workers safety and include among the authorised conditions of use the application of adequate personal protective equipment as well as respiratory protective equipment,the risk to birds and mammals. Risk mitigation measures should be applied to grant a high degree of incorporation in soil and avoidance of spillage,ensure that the label of treated seed includes the indication that the seeds were treated with tefluthrin and sets out the risk mitigation measures provided for in the authorisation.The applicant shall submit confirmatory information as regards:(1) the specification of the technical material, as commercially manufactured;(2) a validated analytical method for water;(3) the possible environmental impact of the preferential degradation/conversion of the isomers and an estimation of the relative toxicity and risk assessment for the workers.The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 June 2012, the information set out in point (2) by 31 December 2012, and the information set out in point (3) 2 years after the adoption of a specific guidance document on evaluation of isomers mixture.
11	OxyfluorfenCAS No 42874-03-3CIPAC No 538	2-chloro-α,α,α-trifluoro-p-tolyl 3-ethoxy-4-nitrophenyl ether	≥ 970 g/kgImpurities:N,N-dimethylnitrosamine: not more than 50 μg/kg	1 January 2012	31 May 2027	PART AOnly uses as herbicide for banded applications close to ground from autumn to early spring may be authorised, at a rate not exceeding 150 g active substance per hectare, per year.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxyfluorfen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed, shall be taken into account.In this overall assessment, Member States must pay particular attention to:operator safety and ensure that conditions of use impose the application of adequate personal protective equipment where appropriate,the risks to aquatic organisms, earthworm-eating mammals, soil-living macro-organisms, non-target arthropods and non-target plants.Conditions of authorisation shall include risk mitigation measures such as no-spray buffer zones and drift reducing nozzles and shall provide for respective labelling of plant protection products. Those conditions shall include further risk mitigation measures, where appropriate.
12	1-naphthylacetamideCAS No 86-86-2CIPAC No 282	2-(1-naphthyl)acetamide	≥ 980 g/kg	1 January 2012	30 November 2029	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1-naphthylacetamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account.In this overall assessment Member States:(a) shall pay particular attention to the risk to operators and workers and ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;(b) shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;(c) shall pay particular attention to the risk to aquatic organisms;(d) shall pay particular attention to the risk to non-target plants;(e) shall pay particular attention to the risk to birds.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the risk to non-target plants;(2) the long-term risk to birds.The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.
13	1-naphthylacetic acidCAS No 86-87-3CIPAC No 313	1-naphthylacetic acid	≥ 980 g/kg	1 January 2012	30 November 2029	PART AOnly uses as plant growth regulator may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1-naphthylacetic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States:(a) shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;(b) shall pay particular attention to the dietary exposure situation of consumers in view of future revisions of maximum residue levels;(c) shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;(d) shall pay particular attention to the risk to aquatic organisms;(e) shall pay particular attention to the risk to birds.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the route and rate of degradation in soil including an assessment of the potential for photolysis;(2) the long-term risk to birds.The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.
14	FluquinconazoleCAS No 136426-54-5CIPAC No 474	3-(2,4-dichlorophenyl)-6-fluoro-2-(1H-1,2,4-triazol-1-yl)quinazolin-4(3H)-one	≥ 955 g/kg	1 January 2012	31 December 2021	PART AOnly uses as fungicide may be authorisedPART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluquinconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States:(a) shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;(b) shall pay particular attention to the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs);(c) shall pay particular attention to the risk to birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;(2) the contribution of the potential residues of the metabolite dione in rotational crops to the overall consumer exposure;(3) the acute risk to insectivorous mammals;(4) the long-term risk to insectivorous and herbivorous birds and mammals;(5) the risk to earthworm-eating mammals;(6) the endocrine disruption potential in aquatic organisms (fish full life cycle study).The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.
15	Fluazifop PCAS No 83066-88-0 (fluazifop-P)CIPAC No 467 (fluazifop-P)	(R)-2-{4-[5-(trifluoromethyl)-2-pyridyloxy]phenoxy}propionic acid (fluazifop-P)	≥ 900 g/kg in fluazifop P-butylThe following impurity 2-chloro-5-(trifluoromethyl)pyridine must not exceed 1,5 g/kg in the material as manufactured.	1 January 2012	30 November 2029	PART AOnly uses as herbicide may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluazifop-P, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013, shall be taken into account.In this overall assessment Member States shall:pay particular attention to consumer safety as regards the occurrence in groundwater of the metabolite compound X;pay particular attention to operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;pay particular attention to the protection of surface water and groundwater in vulnerable zones;pay particular attention to the risk for non-target plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the specification of the technical material, as commercially manufactured, including information on the relevance of the impurity R154719;(2) the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies;(3) the potential long-term risk to herbivorous mammals;(4) the fate and behaviour in the environment of the metabolite compounds X and IV;(5) the potential risk to fish and aquatic invertebrates for the metabolite compound IV.The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012 and the information set out in points (3), (4) and (5) by 31 December 2013.
16	TerbuthylazineCAS No 5915-41-3CIPAC No 234	N2-tert-butyl-6-chloro-N4-ethyl-1,3,5-triazine-2,4-diamine	≥ 950 g/kgThe following impurities are of toxicological concern and must not exceed the following levels in the technical material:Propazine: maximum of 9 g/kgAtrazine: maximum of 1 g/kgSimazine: maximum of 9 g/kg	1 January 2012	31 May 2027	PART AOnly uses as herbicide may be authorised.Use shall be limited to one application every three years on the same field at a maximum dose of 850 g terbuthylazine per hectare.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on terbuthylazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 and updated by the Standing Committee on Plants, Animals, Food and Feed on 24 March 2021 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the consumer risk assessment from exposure to metabolites of terbuthylazine,the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,the risk to mammals and earthworms.Conditions of use shall include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate.
17	TriazoxideCAS No 72459-58-6CIPAC No 729	7-chloro-3-imidazol-1-yl-1,2,4-benzotriazine 1-oxide	≥ 970 g/kgImpurities:toluene: not more than 3 g/kg	1 October 2011	30 September 2021	PART AOnly uses as fungicide for use as seed treatment may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on triazoxide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011, shall be taken into account.In this overall assessment Member States:(a) shall pay particular attention to the protection of operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;(b) shall pay particular attention to the risk to granivorous birds and shall ensure that conditions of authorisation include risk mitigation measures.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the long-term risk to granivorous mammals by 30 September 2013.
18	8-hydroxyquinolineCAS No148-24-3 (8-hydroxyquinoline)CIPAC No 677(8-hydroxyquinoline)	8-quinolinol	≥ 990 g/kg	1 January 2012	31 December 2025	PART AOnly uses as fungicide and bactericide in greenhouses may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 8-hydroxyquinoline, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to the operator safety and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate.The applicant shall submit confirmatory information on 8-hydroxyquinoline and its salts as regards:(1) the method of analysis for air;(2) a new storage stability covering the storage time periods of samples from both the metabolism study and from the supervised reidue trials.The applicant shall submit to the Commission, the Member States and the Authority such information by 31 December 2013.
19	AcrinathrinCAS No 101007-06-1CIPAC No 678	(S)-α-cyano-3-phenoxybenzyl (Z)-(1R,3S)-2,2-dimethyl-3-[2-(2,2,2-trifluoro-1-trifluoromethylethoxycarbonyl)vinyl]cyclopropanecarboxylate or(S)-α-cyano-3-phenoxybenzyl (Z)-(1R)-cis-2,2-dimethyl-3-[2-(2,2,2-trifluoro-1-trifluoromethylethoxycarbonyl)vinyl]cyclopropanecarboxylate	≥ 970 g/kgImpurities:1,3-dicyclohexylurea: not more than 2 g/kg	1 January 2012	31 December 2021.	PART AOnly uses as insecticide and acaricide may be authorised at rates not exceeding 22,5 g/ha per application.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on acrinathrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 July 2011 shall be taken into account.In this overall assessment Member States:(a) shall pay particular attention to the protection of operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;(b) shall pay particular attention to the risk to aquatic organisms, in particular fish, and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate;(c) shall pay particular attention to the risk to non-target arthropods and bees and shall ensure that conditions of authorisation include risk mitigation measures.The applicant shall submit confirmatory information as regards:(1) the potential risk to groundwater from the metabolite 3-PBAld;(2) the chronic risk to fish;(3) the risk assessment for non-target arthropods;(4) the possible impact on the worker, the consumer and the environmental risk assessment of the potential stereo-selective degradation of each isomer in plant, animals and the environment.The applicant shall submit to the Commission, the Member States and the Authority the information set out in points 1, 2 and 3 by 31 December 2013 and the information set out in point 4 2 years after the adoption of specific guidance.
20	ProchlorazCAS No 67747-09-5CIPAC No 407	N-propyl-N-[2-(2,4,6-trichlorophenoxy)ethyl]imidazole-1-carboxamide	≥ 970 g/kgImpurities:Sum of dioxins and furans (WHO-PCDD/T TEQ)^note: not more than 0,01 mg/kg	1 January 2012	31 December 2021.	PART AOnly uses as fungicide may be authorised. In the case of outdoor uses, rates shall not exceed 450 g/ha per application.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on prochloraz, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011, shall be taken into account.In this overall assessment Member States:(a) shall pay particular attention to the protection of operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;(b) shall pay particular attention to the risk to aquatic organisms, and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate;(c) shall pay particular attention to the long-term risk to mammals and shall ensure that conditions of authorisation include risk mitigation measures, where appropriate.The applicants shall submit confirmatory information as regards:(1) comparison and verification of the test material used in the mammalian toxicity and ecotoxicity dossiers against the specification of the technical material;(2) the environmental risk assessment for the metal complexes of prochloraz;(3) the potential endocrine disrupting properties of prochloraz on birds.The notifier shall submit to the Commission, the Member States and the Authority the information set out in points 1 and 2 by 31 December 2013 and the information set out in point 3 within 2 years after the adoption of the pertinent OECD test guidelines on endocrine disruption.
21	BitertanolCAS No: 55179-31-2CIPAC No: 386	(1RS,2RS;1RS,2SR)-1-(biphenyl-4-yloxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol (20:80 ratio of (1RS,2RS)- and (1RS,2SR)-isomers)	≥ 970 g/kg (A ≥ 80, B ≤ 20)RS + SR 80 – 90 %RR + SS 10 – 20 %	1 January 2012	30 June 2015	PART AOnly uses as fungicide for seed treatment may be authorised.Member States shall ensure that authorisations provide that seed coating be performed exclusively in professional seed treatment facilities and that these facilities apply the best available techniques to exclude the release of dust clouds during storage, transport and application.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bitertanol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 October 2011 shall be taken into account.In this overall assessment Member States:(a) shall pay particular attention to the risk to operators and workers and shall ensure that conditions of use include the application of adequate personal protective equipment, where appropriate;(b) shall pay particular attention to the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs);(c) shall pay particular attention to the risk to birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the toxicological relevance of the impurities BUE 1662, thus referred to for confidentiality reasons, and 3-chlorophenoxy compound;(2) the acute and short-term risk to granivorous birds;(3) the long-term risk to granivorous mammals;(4) residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;(5) the possible impact of the variable isomer-ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environmental risk assessment.The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (1) by 30 June 2012, the information set out in points (2), (3) and (4) by 31 December 2013 and the information set out in point (5) two years after the adoption of specific guidance.
22	MetamCAS No 144-54-7CIPAC No 20	Methyldithiocarbamic acid	≥ 965 g/kgExpressed as metam-sodium on a dry weight basis≥ 990 g/kgExpressed as metam-potassium on a dry weight basisRelevant impurities:methylisothiocyanate (MITC)max. 12 g/kg on dry weight basis (metam-sodium),max. 0,42 g/kg on dry weight basis (metam-potassium).N,N’-dimethylthiourea (DMTU)max. 23 g/kg on a dry weight basis (metam-sodium),max. 6 g/kg on a dry weight basis (metam-potassium).	1 July 2012	15 November 2027	PART AOnly uses as nematicide, fungicide, herbicide and insecticide may be authorised for application as soil fumigant prior to planting, limited to one application every third year on the same field.The application may be authorised in open field by soil injection or drip irrigation, and in greenhouse by drip irrigation only. The use of gas-tight plastic film for drip irrigation shall be prescribed.The maximum application rate shall be 153 kg/ha (corresponding to 86,3 kg/ha of MITC) in case of open field applications.Authorisations shall be limited to professional users.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 March 2012, shall be taken into account.In this overall assessment Member States:(a) shall pay particular attention to the protection of operators and shall ensure that the conditions of use include risk mitigation measures such as application of adequate personal protective equipment and a limitation in the daily work rate;(b) shall pay particular attention to the protection of workers and shall ensure that the conditions of use include risk mitigation measures, such as use of adequate personal protective equipment, re-entry period and limitation in the daily work rate;(c) shall pay particular attention to the protection of bystanders and residents and shall ensure that the conditions of use include risk mitigation measures, such as an appropriate buffer zone during and until 24 hours after the application from the perimeter of the application area to any occupied residences and areas used by the general public with obligation to use warning signs and ground markers;(d) shall pay particular attention to the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions and shall ensure that the conditions of use include risk mitigation measures, such as appropriate buffer zone;(e) shall pay particular attention to the risk to non-target organisms and shall ensure that conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information on methyl isothiocyanate as regards:(1) the assessment of the long-range atmospheric transport potential and related environmental risks;(2) the potential groundwater contamination.The applicant shall submit to the Commission, the Member States and the Authority such information by 31 May 2014.
23	BifenthrinCAS No82657-04-3CIPAC No 415	2-methylbiphenyl-3-ylmethyl (1RS,3RS)-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylateor2-methylbiphenyl-3-ylmethyl (1RS)-cis-3-[(Z)-2-chloro-3,3,3-trifluoroprop-1-enyl]-2,2-dimethylcyclopropanecarboxylate	≥ 930 g/kgImpurities:Toluene: not more than 5 g/kg	1 August 2012	31 July 2019	PART AOnly uses as insecticide in greenhouses with a permanent structure may be authorised.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bifenthrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.In this overall assessment, Member States must pay particular attention to:(a) releases from greenhouses, such as condensation water, drain water, soil or artificial substrate, in order to preclude risks to aquatic and other non-target organisms;(b) the protection of pollinator colonies purposely placed in the greenhouse;(c) the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate.Conditions of authorisation shall include risk mitigation measures and provide for adequate labelling of plant protection products.
24	FluxapyroxadCAS No 907204-31-3CIPAC No 828	3-(difluoromethyl)-1-methyl-N-(3′,4′,5′-trifluorobiphenyl-2-yl)pyrazole-4-carboxamide	≥ 950 g/kgThe impurity toluene must not exceed 1 g/kg in the technical material	1 January 2013	31 October 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluxapyroxad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to groundwater, if the active substance is applied under vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, where appropriate.The purity given in this entry is based on a pilot plant production. The examining Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured.
25	FenpyrazamineCAS No 473798-59-3CIPAC No 832	S-allyl 5-amino-2,3-dihydro-2-isopropyl-3-oxo-4-(o-tolyl)pyrazole-1-carbothioate	≥ 960 g/kgThe following manufacturing impurity is of toxicological concern and must not exceed the following amount in the technical material:Hydrazine: maximum content: < 0,0001 % (1 mg/kg)	1 January 2013	15 January 2025	PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenpyrazamine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 and the Standing Committee on Plants, Animals, Food and Feed on 18 May 2020 shall be taken into account. The purity given in this entry is based on a commercial plant production.
26	Adoxophyes orana granulovirusCulture collection No DSM BV-0001CIPAC No 782	Not applicable	No relevant impurities	1 February 2013	31 January 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Adoxophyes orana granulovirus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 July 2012 shall be taken into account.
27	IsopyrazamCAS No 881685-58-1(syn-isomer: 683777-13-1/anti-isomer: 683777-14-2)CIPAC No 963	A mixture of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide(syn-isomer – 50:50 mix of two enantiomers)and3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide(anti-isomer– 50:50 mix of two enantiomers)In a range of 78:15 % to 100:0 % syn to anti.	≥ 920 g/kgIn a range of 78:15 % to 100:0 % syn- to anti-isomers	1 April 2013	31 March 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on isopyrazam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the risk to aquatic organisms;(b) the risk to earthworms if the substance is applied in the framework of no cultivation/minimum cultivation practices;(c) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, like the exclusion of no cultivation/minimum cultivation practices, and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate.The applicant shall submit confirmatory information as regards the relevance of the metabolites CSCD 459488 and CSCD 459489 for groundwater.The applicant shall submit to the Commission, the Member States and the Authority this information by 31 July 2017.
28	PhosphaneCAS No 7803-51-2CIPAC No 127	Phosphane	≥ 994 g/kgThe relevant impurity arsane must not exceed 0,023 g/kg in the technical material	1 April 2013	15 March 2027	Authorisations shall be limited to professional users.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on phosphane, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators in and around the treated premises during the treatment as well as during and after the aeration;the protection of workers in and around the treated premises during the treatment as well as during and after the aeration;the protection of bystanders around the treated premises during the treatment as well as during and after the aeration.Conditions of use shall include risk mitigation measures, like permanent monitoring of the phosphane concentration by automatic devices, the use of personal protection equipment and setting-up an area around the treated premise where bystanders are denied, where appropriate.
29	Trichoderma asperellum (strain T34)CECT number: 20417	Not applicable	1 × 10¹⁰ cfu/g	1 June 2013	15 October 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma asperellum (strain T34), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Trichoderma asperellum (strain T34) is to be considered as a potential sensitiser.Conditions of use shall include risk mitigation measures where appropriate.
30	Zucchini Yellow Mosaic Virus — weak strainATCC accession number: PV-593	Not applicable	≥ 0,05 mg/l	1 June 2013	31 May 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Zucchini Yellow Mosaic Virus — weak strain, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to non-target plants, if the crop plants are co-infected with another virus which can be transmitted by aphids.Conditions of use shall include risk mitigation measures, where appropriate.
31	CyflumetofenCAS No 400882-07-7CIPAC No 721	2-methoxyethyl (RS)-2-(4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoro-o-tolyl)propionate	≥ 975 g/kg (racemic)	1 June 2013	15 October 2027	Plant protection products containing cyflumetofen shall only be authorised for uses where the level of metabolite B3 in groundwater is expected to be below 0,1 μg/L.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyflumetofen, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012 shall be taken into account.In this overall assessment, Member States shall pay particular attention to:the protection of operators and workers;the protection of groundwater, in particular for metabolite B3, when the substance is applied in regions with vulnerable soils and/or climatic conditions;the protection of drinking water;the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.
32	Trichoderma atroviride strain I-1237CNCM number: I-1237	Not applicable	1 109 cfu/g (1 1010 spores/g)	1 June 2013	15 October 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Trichoderma atroviride strain I-1237, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 November 2012, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Trichoderma atroviride strain I-1237 is to be considered a potential sensitiser.Conditions of use shall include risk mitigation measures where appropriate.
33	AmetoctradinCAS No 865318-97-4CIPAC No 818	5-ethyl-6-octyl [1,2,4]triazolo[1,5-a] pyrimidin-7-amine	≥ 980 g/kgThe impurities amitrole and o-xylene are of toxicological relevance and shall not exceed 50 mg/kg and 2 g/kg respectively in the technical material.	1 August 2013	31 May 2028	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ametoctradin, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to the leakage of metabolite M650F04^note to groundwater under vulnerable conditions.Conditions of use shall include risk mitigation measures, where appropriate.
34	MandipropamidCAS No 374726-62-2CIPAC No 783	(RS)-2-(4-chlorophenyl)-N-[3-methoxy-4-(prop-2-ynyloxy)phenethyl]-2-(prop-2-ynyloxy)acetamide	≥ 930 g/kgThe impurity N-{2-[4-(2-chloro-allyloxy)-3-methoxy-phenyl]-ethyl}-2-(4-chloro-phenyl)-2-prop-2-ynyloxy-acetamide is of toxicological relevance and shall not exceed 0,1 g/kg in the technical material.	1 August 2013	30 June 2029	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mandipropamid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 February 2013 shall be taken into account.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the potential for preferential enantiomeric transformation or racemisation of mandipropamid at the soil surface as a result of soil photolysis.The applicant shall submit to the Commission, the Member States and the Authority that information by 31 July 2015.
35	Halosulfuron-methylCAS No 100785-20-1CIPAC No 785.201	methyl 3-chloro-5-(4,6-dimethoxypyrimidin-2-ylcarbamoylsulfamoyl)-1-methylpyrazole-4-carboxylate	≥ 980 g/kg	1 October 2013	15 November 2026	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on halosulfuron-methyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk of leakage to groundwater of the metabolite halosulfuron rearrangement (HSR) under vulnerable conditions. This metabolite is considered toxicologically relevant based on the available information for halosulfuron,the risk to non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(a) information as regards the equivalence between the specifications of the technical material, as commercially manufactured, and the test material used in the toxicological and ecotoxicological studies;(b) information on the toxicological relevance of the impurities present in the technical specification as commercially manufactured;(c) data to clarify the potential genotoxic properties of chlorosulfonamide acid.The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.
36	Bacillus firmus I-1582Collection number: CNCMI-1582	Not applicable	Minimum concentration: 7,1 × 10¹⁰ CFU/g	1 October 2013	30 September 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus firmus I-1582, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Bacillus firmus I-1582 is to be considered as a potential sensitiser.Conditions of use shall include risk mitigation measures, where appropriate.
37	Candida oleophilastrain OCollection number: MUCL40654	Not applicable	Nominal content: 3 × 10¹⁰ CFU/g dried productRange: 6 × 10⁹ – 1 × 10¹¹ CFU/g dried product	1 October 2013	31 May 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Candida oleophila strain O, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
38	Helicoverpa armigera nucleopolyhedrovirusDSMZ number: BV-0003	Not applicable	Minimum concentration: 1,44 × 10¹³ OB/l (occlusion bodies/l)	1 June 2013	15 October 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Helicoverpa armigera nucleopolyhedrovirus, and in particular Appendices I and II thereto, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account.
39	Paecilomyces fumosoroseus strain FE 9901Collection number: USDA-ARS collection of Entomopathogenic Fungal Cultures U.S. Plant Soil and Nutrition laboratory. New York. Accession No ARSEF 4490	Not applicable	Minimum 1,0 × 10⁹ CFU/gMaximum 3,0 × 10⁹ CFU/g	1 October 2013	31 May 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Paecilomyces fumosoroseus strain FE 9901, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Paecilomyces fumosoroseus strain FE 9901 is to be considered as a potential sensitiser.Conditions of use shall include risk mitigation measures, where appropriate.
40	Potassium phosphonates (no ISO name)CAS No13977-65-6 for potassium hydrogen phosphonate13492-26-7 for dipotassium phosphonateMixture: noneCIPAC No 756 (for potassium phosphonates)	Potassium hydrogen phosphonate,Dipotassium phosphonate	31,6 to 32,6 % phosphonate ions (sum of hydrogen phosphonate and phosphonate ions)17,8 to 20,0 % potassium≥ 990 g/kg on dry weight basis	1 October 2013	31 July 2029	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on potassium phosphonates, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to birds and mammals,the risk of eutrophication of surface water, if the substance is applied in regions or under conditions favouring a quick oxidation of the active substance in surface water.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the long-term risk to insectivorous birds.The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.
41	SpiromesifenCAS No 283594-90-1CIPAC No 747	3-mesityl-2-oxo-1-oxaspiro[4.4]non-3-en-4-yl 3,3-dimethylbutyrate	≥ 965 g/kg (racemic)The impurity N,N-dimethylacetamide is of toxicological relevance and must not exceed 4 g/kg in the technical material.	1 October 2013	30 September 2023	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on spiromesifen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the long-term risk to aquatic invertebrates,the risk to pollinating hymenoptera and non-target arthropods if exposure is not negligible,the protection of workers and operators.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the recalculation of the predicted concentration in groundwater (PECGW) with a FOCUS GW scenario adapted to the supported uses using a Q10 value of 2,58.The applicant shall submit to the Commission, the Member States and the Authority that information by 30 September 2015.
42	Spodoptera littoralis nucleopolyhedrovirusDSMZ number: BV-0005	Not applicable	Maximum concentration: 1 × 10¹² OB/l (occlusion bodies/l)	1 June 2013	15 October 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Spodoptera littoralis nucleopolyhedrovirus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.
43	BixafenCAS No 581809-46-3CIPAC No 819	N-(3′,4′-dichloro-5-fluorobiphenyl-2-yl)-3-(difluoromethyl)-1-methylpyrazole-4-carboxamide	≥ 950 g/kg	1 October 2013	31 October 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bixafen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the residues of bixafen and of its metabolites in rotational crops;(b) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;(c) the risk to aquatic organisms;(d) the risk to soil and sediment-dwelling organisms.Conditions of use shall include risk mitigation measures, where appropriate.
44	MaltodextrinCAS No 9050-36-6CIPAC No 801	None allocated	≥ 910 g/kg	1 October 2013	28 February 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on maltodextrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the potential increased growth of fungi and possible presence of mycotoxins on the surface of treated fruits;(b) the potential risk to honeybees and non-target arthropods.Conditions of use shall include risk mitigation measures, where appropriate.
45	Eugenol CAS No 97-53-0CIPAC No 967	4-allyl-2-methoxyphenol	≥ 990 g/kgRelevant impurity: methyl eugenol maximum 0,1 % of the technical material	1 December 2013	15 April 2028	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on eugenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate,the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions,the risk to aquatic organisms,the risk to insectivorous birds.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(a) the storage stability (2 years) at ambient temperature on the formulated product;(b) data comparing natural background exposure situations of eugenol and methyl eugenol in relation to exposure from the use of eugenol as a plant protection product. This data shall cover human exposure as well as exposure of birds and aquatic organisms;(c) the groundwater exposure assessment for potential metabolites of eugenol, in particular for methyl eugenol.The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.
46	Geraniol CAS No 106-24-1CIPAC No 968	(E) 3,7-dimethyl-2,6-octadien-1-ol	≥ 980 g/kg	1 December 2013	15 April 2028	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on geraniol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention tothe protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;the risk to aquatic organisms;the risk to birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards(a) data comparing natural background exposure situations of geraniol in relation to exposure from the use of geraniol as a plant protection product. This data shall cover human exposure as well as exposure of birds, mammals and aquatic organisms;(b) the groundwater exposure.The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.
47	ThymolCAS No89-83-8CIPAC No969	5-methyl-2-propan-2-yl-phenol	≥ 990 g/kg	1 December 2013	15 April 2028	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thymol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 May 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention tothe protection of operators, workers, bystanders and residents, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;the risk to aquatic organisms;the risk to birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards(a) data comparing natural background exposure situations of thymol in relation to exposure from the use of thymol as a plant protection product. This data shall cover human exposure as well as exposure of birds, mammals and aquatic organisms;(b) the long-term and reproductive toxicity, in a form of a full report (in English) of the Combined Test of Repeated Oral-Administration Toxicity and Reproductive Toxicity of Thymol;(c) the groundwater exposure.The applicant shall submit to the Commission, the Member States and the Authority that information by 30 November 2015.
48	SedaxaneCAS No 874967-67-6(trans isomer: 599197-38-3/cis isomer: 599194-51-1)CIPAC No 833	mixture of 2 cis-isomers 2′-[(1RS,2RS)-1,1′-bicycloprop-2-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxanilide and 2 trans-isomers 2′-[(1RS,2SR)-1,1′-bicycloprop-2-yl]-3-(difluoromethyl)-1-methylpyrazole-4-carboxanilide	≥ 960 g/kg Sedaxane(range 820-890 g/kg for the 2 trans-isomers 50:50 mixture of enantiomers and range 100-150 g/kg for the 2 cis-isomers 50:50 mixture of enantiomers)	1 February 2014	31 October 2027	PART AOnly uses for seed treatment may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sedaxane, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;(b) the long-term risk to birds and mammals.Conditions of authorisation shall include risk mitigation measures, where appropriate.The Member States concerned shall carry out monitoring programmes to verify potential groundwater contamination from the metabolite CSCD465008 in vulnerable zones, where appropriate.The Member States concerned shall request the submission of confirmatory information as regards the relevance of the metabolite CSCD465008, and the corresponding groundwater risk assessment, if sedaxane is classified under Regulation (EC) No 1272/2008 as ‘suspected of causing cancer’.The notifier shall submit to the Commission, the Member States and the Authority the relevant information within six months from the application date of the Regulation classifying sedaxane.
49	EmamectinCAS Noemamectin: 119791-41-2(formerly 137335-79-6) and 123997-28-4emamectin benzoate: 155569-91-8(formerly 137512-74-4 and 179607-18-2)emamectin B1a benzoate: 138511-97-4emamectin B1b benzoate: 138511-98-5CIPAC Noemamectin: 791emamectin benzoate: 791.412	Emamectin B1a:(10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-L-lyxo-hexapyranosyl)-α-L-arabino-hexapyranosideEmamectin B1b:(10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-L-lyxo-hexapyranosyl)-α-L-arabino-hexapyranosideEmamectin B1a benzoate:(10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-L-lyxo-hexapyranosyl)-α-L-arabino-hexapyranoside benzoateEmamectin B1b benzoate:(10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-L-lyxo-hexapyranosyl)-α-L-arabino-hexapyranoside benzoate	≥ 950 g/kgas emamectin benzoate anhydrous(a mixture of min. 920 g/kg emamectin B1a benzoate and max. 50 g/kg emamectin B1b benzoate)	1 May 2014	15 November 2026	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on emamectin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to non-target invertebrates;the protection of workers and operators.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the risk of enantio-selective metabolisation or degradation.The applicant shall submit to the Commission, Member States and the Authority the relevant information two years after adoption of the pertinent guidance document on evaluation of isomer mixtures.
50	Pseudomonas sp. strain DSMZ 13134Collection number: DSMZ 13134	Not applicable	Minimum concentration: 3×10¹⁴ cfu/kg	1 February 2014	30 June 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Pseudomonas sp. strain DSMZ 13134, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Pseudomonas sp. strain DSMZ 13134 is to be considered as a potential sensitizer.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit information to confirm the absence of an acute intratracheal and intraperitoneal toxicity/infectivity/pathogenicity potential.The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.
51	FluopyramCAS No 658066-35-4CIPAC No 807	N-{2-[3-chloro-5-(trifluoromethyl)-2-pyridyl]ethyl}-α,α,α-trifluoro-o-toluamide	≥ 960 g/kg	1 February 2014	15 June 2028	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluopyram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to birds and aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the long-term risk to insectivorous birds;(2) the potential for causing endocrine disrupting effects in non-target vertebrates other than mammals.The applicant shall submit to the Commission, Member States and the Authority the information set out in point 1 by 1 February 2016 and the information set out in point 2 within two years after adoption of the corresponding OECD test guidelines on endocrine disruption.
52	Aureobasidium pullulans (strains DSM 14940 and DSM 14941)Collection number: German Collection of Microorganisms and cell Cultures (DSMZ) with the accession numbers DSM 14940 and DSM 14941	Not applicable	Minimum 5,0 × 10⁹ CFU/g for each strain;Maximum 5,0 × 10¹⁰ CFU/g for each strain	1 February 2014	30 June 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Aureobasidium pullulans (strains DSM 14940 and DSM 14941), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Aureobasidium pullulans (strains DSM 14940 and DSM 14941) is to be considered as a potential sensitizer.Conditions of use shall include risk mitigation measures, where appropriate.
53	Pyriofenone:CAS No 688046-61-9CIPAC No 827	(5-chloro-2-methoxy-4-methyl-3-pyridyl)(4,5,6-trimethoxy-o-tolyl)methanone	≥ 965 g/kg	1 February 2014	30 June 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyriofenone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards(a) the identity of two impurities to fully support the provisional specification;(b) the toxicological relevance of the impurities present in the proposed technical specification except for the one impurity for which an acute oral study and an Ames test were provided.The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.
54	Disodium phosphonateCAS No 13708-85-5CIPAC No 808	disodium phosphonate	281-337 g/kg (TK)≥ 917 g/kg (TC)	1 February 2014	31 July 2029	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on disodium phosphonate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 16 July 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to eutrophication of surface water.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards(a) the chronic risk to fish;(b) the long term risk to earthworms and soil macro-organisms.The applicant shall submit to the Commission, the Member States and the Authority that information by 31 January 2016.
55	PenflufenCAS No 494793-67-8CIPAC No 826	2’-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide	≥ 950 g/kg1:1 (R:S) ratio of enantiomers	1 February 2014	31 January 2024	PART AOnly uses to treat cereal seeds before or during sowing may be authorised, limited to one application every third year on the same field.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on penflufen, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment, Member States shall pay particular attention to:(a) the protection of operators;(b) the protection of birds;(c) the protection of groundwater, when the substance is applied to regions with vulnerable soil and/or climatic conditions;(d) to the residues in surface water abducted for drinking water purposes, in or from areas where products containing penflufen are used.Conditions of use shall include risk mitigation measures, where appropriate.
56	Orange oilCAS No 8028-48-6 (Orange extract)5989-27-5 (D-limonene)CIPAC No 902	(R)-4-isopropenyl-1-methylcyclohexene or p-mentha-1,8-diene	≥ 945 g/kg (of D-limonene)The active substance shall comply with the specifications of Ph. Eur. (Pharmacopoeia Europea) 5.0 (Aurantii dulcis aetheroleum) and ISO 3140:2011(E)	1 May 2014	31 December 2026	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on orange oil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the protection of operators and workers;(b) the risk to birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the metabolite fate of orange oil and the route and rate of degradation in soil and on the validation of endpoints used in the ecotoxicological risk assessment.The applicant shall submit that information to the Commission, Member States and the Authority by 30 April 2016.
57	PenthiopyradCAS No 183675-82-3CIPAC No 824	(RS)-N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)pyrazole-4-carboxamide	≥ 980 g/kg(50:50 racemic mixture)	1 May 2014	31 October 2025	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on penthiopyrad, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the protection of operators and workers;(b) the risk to aquatic and soil organisms;(c) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;(d) the level of residues in rotational crops following consecutive application of the active substance over several years.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the non-relevance of metabolite M11 (3-methyl-1-{3-[(1-methyl-3-trifluoromethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2-yl}pentanoic acid) for groundwater with the exception of evidence related to the risk of carcinogenicity, which is dependent on the classificationof the parent and specified separately at (3) below;(2) the toxicological profile and the reference values of the metabolite PAM;(3) the relevance of the metabolites M11 (3-methyl-1-{3-[(1-methyl-3-trifluoromethyl-1H-pyrazole-4-carbonyl)amino]thiophen-2-yl}pentanoic acid), DM-PCA (3-trifluoromethyl-1H-pyrazole-4- carboxylic acid), PAM (1-methyl-3-trifluoromethyl-1H-pyrazole-4-carboxamide) and PCA (1-methyl-3-trifluoromethyl-1H-pyrazole-4-carboxylic acid) and their risk to contaminate groundwater, if penthiopyrad is classified under Regulation (EC) No 1272/2008 as carcinogenic cat. 2.The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in points (1) and (2) by 30 April 2016 and the information set out in point (3) within six months from the notification of the classification decision concerning penthiopyrad.
58	Benalaxyl-MCAS No 98243-83-5CIPAC No 766	Methyl N-(phenylacetyl)-N-(2,6-xylyl)-D-alaninate	≥ 950 g/kg	1 May 2014	30 September 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on benalaxyl-M, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of workers at re-entry,the risk to groundwater from the metabolites BM-M2 (N-(malonyl)-N-(2,6-xylyl)-DL-alanine) and BM-M3 (N-(malonyl)-N-(2,6-xylyl)-D-alanine), when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, where appropriate.
59	TembotrioneCAS No 335104-84-2CIPAC No 790	2-{2-chloro-4-mesyl-3-[(2,2,2-trifluoroethoxy)methyl]benzoyl}cyclohexane-1,3-dione	≥ 945 g/kgThe following relevant impurities must not exceed a certain threshold in the technical material:Toluene: ≤ 10 g/kgHCN: ≤ 1 g/kg	1 May 2014	31 December 2026	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on tembotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the protection of operators and workers;(b) the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.
60	SpirotetramatCAS No 203313-25-1CIPAC No 795	cis-4-(ethoxycarbonyloxy)-8-methoxy-3-(2,5-xylyl)-1-azaspiro[4.5]dec-3-en-2-one	≥ 970 g/kg	1 May 2014	30 April 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on spirotetramat, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to insectivorous birds.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the potential for endocrine disruptor effects in birds and fish to the Commission, the Member States and the Authority within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.
61	PyroxsulamCAS No 422556-08-9CIPAC No 793	N-(5,7-dimethoxy[1,2,4]triazolo[1,5-a]pyrimidin-2-yl)-2-methoxy-4-(trifluoromethyl)pyridine-3-sulfonamide	≥ 965 g/kg	1 May 2014	30 September 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyroxsulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the risk to groundwater, when the active substance is applied in regions with vulnerable soil or climatic conditions;(b) the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the toxicological relevance of impurity number 3 (as referred to in the review report);(2) the acute toxicity of the metabolite PSA;(3) the toxicological relevance of metabolite 6-Cl-7-OH-XDE-742.The applicant shall submit to the Commission, Member States and the Authority that information by 30 April 2016.
62	ChlorantraniliproleCAS No 500008-45-7CIPAC No 794	3-bromo-4'-chloro-1-(3-chloro-2-pyridyl)-2'-methyl-6'-(methylcarbamoyl) pyrazole-5-carboxanilide	≥ 950 g/kgThe following relevant impurities must not exceed a certain threshold in the technical material:Acetonitrile: ≤ 3 g/kg3-picoline: ≤ 3 g/kgMethanesulfonic acid: ≤ 2 g/kg	1 May 2014	31 May 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chlorantraniliprole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms and to soil macroorganisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the risk to groundwater from the active substance and its metabolites IN-EQW78 (2-[3-bromo-1-(3-chloropyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-3,8-dimethylquinazolin-4(3H)-one), IN-ECD73 (2,6-dichloro-4-methyl-11H-pyrido[2,1-b]quinazolin-11-one), IN-F6L99 (3-bromo-N-methyl-1H-pyrazole-5-carboxamide), IN-GAZ70 (2-[3-bromo-1-(3-chloropyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-8-methylquinazolin-4(1H)-one) and IN-F9N04 (3-bromo-N-(2-carbamoyl-4-chloro-6-methylphenyl)-1-(3-chloropyridin-2-yl)-1H-pyrazole-5-carboxamide);(2) the risk to aquatic organisms from the photolysis metabolites IN-LBA22 (2-{[(4Z)-2-bromo-4H-pyrazolo[1,5-d]pyrido[3,2-b][1,4]oxazin-4-ylidene] amino}-5-chloro-N,3-dimethylbenzamide), IN-LBA23 (2-[3-bromo-1-(3-hydroxypyridin-2-yl)-1H-pyrazol-5-yl]-6-chloro-3,8-dimethylquinazolin-4(3H)-one) and IN-LBA24 (2-(3-bromo-1H-pyrazol-5-yl)-6-chloro-3,8-dimethylquinazolin-4(3H)-one).The applicant shall submit to the Commission, Member States and the Authority that information by 30 April 2016.
63	Sodium silver thiosulfateCAS No not allocatedCIPAC No 762	Not applicable	≥ 10,0 g Ag/kgExpressed as silver (Ag)	1 May 2014	31 December 2026	PART AOnly indoor uses in non-edible crops shall be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sodium silver thiosulfate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 3 October 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to(a) the protection of operators and workers;(b) limiting the possible release of silver ions through disposal of used solutions;(c) the risk to terrestric vertebrates and soil invertebrates from the use of sewage sludge in agriculture.Conditions of use shall include risk mitigation measures, where appropriate.
64	PyridalylCAS No 179101-81-6CIPAC No 792	2,6-dichloro-4-(3,3-dichloroallyloxy)phenyl 3-[5-(trifluoromethyl)-2-pyridyloxy]propyl ether	≥ 910 g/kg	1 July 2014	30 June 2024	PART AOnly uses in greenhouses with permanent structure may be authorised.PART BFor the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyridalyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the risk to re-entry workers;(b) the risk to groundwater when the substance is applied in regions with vulnerable soils and/or climatic conditions;(c) the risk to birds, mammals and aquatic organisms.Conditions of authorisation shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the toxicological and ecotoxicological information to address the relevance of impurities 4, 13, 16, 22 and 23;(2) the relevance of the metabolite HTFP and, concerning that metabolite, the groundwater risk assessment for all uses on crops in greenhouse;(3) the risk to aquatic invertebrates.The applicant shall submit to the Commission, the Member States and the Authority the relevant information as regards point (1) by 31 December 2014 and information as regards point (2) and (3) by 30 June 2016.The applicant shall present to the Commission, the Member States and the Authority a monitoring programme to assess the potential groundwater contamination from the metabolite HTFP in vulnerable zones by 30 June 2016. The results of that monitoring programme shall be submitted as a monitoring report to the rapporteur Member State, the Commission and the Authority by 30 June 2018.
65	S-abscisic acidCAS No21293-29-8CIPAC NoNot allocated	(2Z,4E)-5-[(1S)-1-hydroxy-2,6,6-trimethyl-4-oxocyclohex-2-en-1-yl]-3-methylpenta-2,4-dienoic acidor(7E,9Z)-(6S)-6-hydroxy-3-oxo-11-apo-ε-caroten-11-oic acid	960 g/kg	1 July 2014	15 September 2026	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on S-abscisic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.
66	L-ascorbic acidCAS No 50-81-7CIPAC No 774	(5R)-5-[(1S)-1,2-dihydroxyethyl]-3,4-dihydroxyfuran-2(5H)-one	≥ 990 g/kgThe following relevant impurities shall not exceed:Methanol: ≤ 3 g/kgHeavy Metals: ≤ 10 mg/kg (expressed as Pb)	1 July 2014	30 June 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on L-ascorbic acid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the risk to aquatic and soil organisms;(b) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the natural background of L-ascorbic acid in the environment confirming a low chronic risk for fish and a low risk for aquatic invertebrates, algae, earthworms and soil microorganisms;(2) the risk to contaminate groundwater.The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.
67	SpinetoramCAS No 935545-74-7CIPAC No 802	XDE-175-J (Major factor)(2R,3aR,5aR,5bS,9S,13S,14R,16aS, 16bR)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,4,5,5a,5b,6,9,10,11,12,13,14,16a,16b-hexadecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dioneXDE_175-L (Minor factor)(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-3-O-ethyl-2,4-di-O-methyl-α-L-mannopyranosyloxy)-13-[(2R,5S,6R)-5-(dimethylamino)tetrahydro-6-methylpyran-2-yloxy]-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione	≥ 830 g/kg50-90 % XDE-175-J;and50-10 % XDE-175-LTolerance limits (g/kg):XDE-175-J = 581-810XDE-175-L = 83-270	1 July 2014	30 June 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on spinetoram, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the risk to aquatic and soil organisms;(b) the risk to non-target arthropods in-field;(c) the risk to bees during the application (overspray) and subsequently.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the equivalence between the stereochemistry of metabolites identified in the metabolism/degradation studies and in the testing material used for the toxicity and ecotoxicity studies.The applicant shall submit to the Commission, the Member States and the Authority the relevant information within 6 months after the adoption of pertinent guidance on the assessment of isomers.
68	1,4-dimethylnaphthaleneCAS No 571-58-4CIPAC No 822	1,4-dimethylnaphthalene	≥ 980 g/kg	1 July 2014	30 November 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1,4-dimethylnaphthalene, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the protection of operators and of workers at re-entry and during inspection of the warehouse;(b) the risk to aquatic organisms and fish-eating mammals the active substance is discharged from warehouses into air and surface water without further treatment.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the residue definition for the active substance.The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.
69	AmisulbromCAS No 348635-87-0CIPAC No 789	3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-N,N-dimethyl-1H-1,2,4-triazole-1-sulfonamide	≥ 985 g/kgThe following relevant impurity must not exceed a certain threshold in the technical material:3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole: ≤ 2 g/kg	1 July 2014	15 September 2026	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on amisulbrom, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic and soil organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the non-significance of photodegradation in the soil metabolism of amisulbrom concerning the metabolites 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole and 1-(dimethylsulfamoyl)-1H-1,2,4-triazole-3-sulfonic acid to contaminate groundwater;(2) the low potential of amisulbrom (FOCUS drainage scenarios only) and metabolites 1-(dimethylsulfamoyl)-1H-1,2,4-triazole-3-sulfonic acid, 1H-1,2,4-triazole-3-sulfonic acid, 1H-1,2,4-triazole, N,N-dimethyl-1H-1,2,4-triazole-3-sulfonamide, 2-acetamido-4-fluorobenzoic acid, 2-acetamido-4-fluoro-hydroxybenzoic acid and 2,2′-oxybis(6-fluoro-2-methyl-1,2-dihydro-3H-indol-3-one) to contaminate surface water or to expose aquatic organisms by runoff;(3) depending on the outcome of the assessment under (1) and (2), where there is considerable photodegradation in soil or where there is high potential for contamination or exposure, additional analytical methods to determine all compounds of the residue definition for monitoring in surface water;(4) the risk from secondary poisoning for birds and mammals by 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole;(5) the potential for causing endocrine disrupting effects in birds and fish by amisulbrom and its metabolite 3-bromo-6-fluoro-2-methyl-1-(1H-1,2,4-triazol-3-ylsulfonyl)-1H-indole.The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in points (1) to (4) by 30 June 2016 and under point (5) within two years after the adoption of pertinent OECD test guidelines on endocrine disruption.
70	ValifenalateCAS No 283159-90-0CIPAC No 857	Methyl N-(isopropoxycarbonyl)-L-valyl-(3RS)-3-(4-chlorophenyl)-β-alaninate	≥ 980 g/kg	1 July 2014	1 March 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on valifenalate, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the potential of metabolite S5 to contaminate groundwater.The notifier shall submit to the Commission, the Member States and the Authority the relevant information by 30 June 2016.
71	ThiencarbazoneCAS No 317815-83-1CIPAC No 797	Methyl 4-[(4,5-dihydro-3-methoxy-4-methyl-5-oxo-1H-1,2,4-triazol-1-yl)carbonylsulfamoyl]-5-methylthiophene-3-carboxylate	≥ 950 g/kg	1 July 2014	1 March 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thiencarbazone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account.In this overall assessment Member States shall pay particular attention to(a) the risk to groundwater if the substance is applied under vulnerable geographical or climatic conditions;(b) the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts.That confirmatory information shall consist of the results of a monitoring programme to assess the potential of thiencarbazone for long-range atmospheric transport and the related environmental impacts. The applicant shall submit to the Commission, the Member States and the Authority this monitoring programme by 30 June 2016 and the results in form of a monitoring report by 30 June 2018.
72	Acequinocyl CAS No 57960-19-7 CIPAC No 760	3-dodecyl-1,4-dihydro-1,4-dioxo-2-naphthyl acetate	≥ 960 g/kg	1 September 2014	15 November 2026	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on acequinocyl, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of workers and operators;the risk to birds, mammals and aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(a) an analytical method for residues in body fluids and tissues;(b) the acceptability of the long-term risk to small granivorous birds and small herbivorous and frugivorous mammals, concerning the use on apple and pear orchards;(c) the acceptability of the long-term risk to small omnivorous and small herbivorous mammals, concerning the use on outdoor ornamentals.The applicant shall submit that information to the Commission, the Member States and the Authority by 31 August 2016.
73	IpconazoleCAS No125225-28-7 (mixture of diastereoisomers)115850-69-6 (ipconazole cc, cis isomer)115937-89-8 (ipconazole ct, trans isomer)CIPAC No 798	(1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl) cyclopentanol	≥ 955 g/kgIpconazole cc: 875 – 930 g/kgIpconazole ct: 65 – 95 g/kg	1 September 2014	30 November 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ipconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to:1. the risk to granivorous birds;2. the protection of workers and operators;3. the risk to fish.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(a) the acceptability of the long-term risk to granivorous birds;(b) the acceptability of the risk to soil macro-organisms;(c) the risk of enantio-selective metabolisation or degradation;(d) the potential endocrine disrupting properties of ipconazole for birds and fish.The applicant shall submit to the Commission, the Member States and the Authority the information under (a) and (b) by 31 August 2016, the information under (c) within two years after adoption of the pertinent guidance document on evaluation of isomer mixtures and the information under (d) within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of test guidelines agreed at EU level.
74	FlubendiamideCAS No 272451-65-7CIPAC No 788	3-iodo-N'-(2-mesyl-1,1-dimethylethyl)-N-{4-[1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethyl]-o-tolyl}phthalamide	≥ 960 g/kg	1 September 2014	31 August 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flubendiamide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the risk to aquatic invertebrates;(b) the potential presence of residues in rotational crops.Conditions of use shall include risk mitigation measures, where appropriate.
75	Bacillus pumilus QST 2808USDA Agricultural Research Service (NRRL) Patent culture collection in Peoria Illinois, USA under the reference number B-30087	Not applicable	≥ 1 × 10¹² CFU/kg	1 September 2014	31 August 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus pumilus QST 2808, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 20 March 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Bacillus pumilus QST 2808 is to be considered as a potential sensitizer.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(a) the identification of the aminosugar produced by Bacillus pumilus QST 2808;(b) analytical data for the content of that aminosugar in the production batches.The applicant shall submit that information to the Commission, the Member States and the Authority by 31 August 2016.
76	MetobromuronCAS No 3060-89-7CIPAC No 168	3-(4-bromophenyl)-1-methoxy-1-methylurea	≥ 978 g/kg	1 January 2015	31 May 2027	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metobromuron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the protection of workers and operators;(b) the risk to birds, mammals, aquatic organisms and terrestrial non-target plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(a) the toxicological assessment of the metabolites CGA 18236, CGA 18237, CGA 18238 and 4-bromoaniline;(b) the acceptability of the long-term risk to birds and mammals.The applicant shall submit that information to the Commission, the Member States and the Authority by 31 December 2016.
77	AminopyralidCAS No 150114-71-9CIPAC No 771	4-amino-3,6-dichloropyridine-2-carboxylic acid	≥ 920 g/kgThe following relevant impurity shall not exceed a certain threshold:Picloram ≤ 40 g/kg	1 January 2015	31 May 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on aminopyralid, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions;(b) the risk to aquatic macrophytes and terrestrial non-target plants;(c) chronic risk to fish.Conditions of use shall include risk mitigation measures, where appropriate.
78	MetaflumizoneCAS No 139968-49-3CIPAC No 779	(EZ)-2′-[2-(4-cyanophenyl)-1-(α,α,α-trifluoro-m-tolyl)ethylidene]-4-(trifluoromethoxy)carbanilohydrazide	≥ 945 g/kg(90-100 % E-isomer10-0 % Z-isomer)The following relevant impurities shall not exceed a certain threshold:Hydrazine ≤ 1 mg/kg4-(trifluoromethoxy)phenyl isocyanate ≤ 100 mg/kgToluene ≤ 2 g/kg	1 January 2015	31 December 2024	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metaflumizone, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the risk to fish and sediment dwelling organisms;(b) the risk to snail- or earthworm-eating birds.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the equivalence of the material used in the toxicological and ecotoxicological studies with the proposed technical specification;(2) information addressing the potential of metaflumizone for bioaccumulation in aquatic organisms and biomagnification in aquatic food chains.The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 June 2015 and under (2) by 31 December 2016.
79	Streptomyces lydicus strain WYEC 108Collection number: American Type Culture Collection (USDA)ATCC 55445	Not applicable	Minimum concentration: 5,0 × 10⁸ CFU/g	1 January 2015	30 June 2029	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Streptomyces lydicus strain WYEC 108, and in particular Appendices I and II thereto, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 11 July 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the risk to aquatic organisms;(b) the risk to soil dwelling organisms.Conditions of use shall include risk mitigation measures, where appropriate.
80	MeptyldinocapCAS No 6119-92-2CIPAC No 811	Mixture of 75-100 % (RS)-2-(1-methylheptyl)-4,6-dinitrophenyl crotonate and 25-– 0 % (RS)-2-(1-methylheptyl)-4,6-dinitrophenyl isocrotonate	≥ 900 g/kg (mixture of trans- and cis-isomers with a defined ratio range of 25:1 to 20:1)Relevant impurity:2,6-dinitro-4-[(4RS)-octan-4-yl]phenyl (2E/Z)-but-2-enoatemax content 0,4 g/kg	1 April 2015	31 March 2025	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on meptyldinocap, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the risk to operators;(b) the risk to aquatic invertebrates.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(a) the groundwater exposure assessment for metabolites (3RS)-3-(2-hydroxy-3,5-dinitro-phenyl)-butanoic acid (X103317) and (2RS)-2-(2-hydroxy-3,5-dinitro-phenyl)-propionic acid (X12335709);(b) the possible impact of any preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and the environment.The applicant shall submit to the Commission, the Member States and the Authority the information set out in point (a) by 31 March 2017 and the information set out in point (b) two years after the adoption of specific guidance by the Commission.
81	ChromafenozideCAS No 143807-66-3CIPAC No 775	N′-tert-butyl-5-methyl-N′-(3,5-xyloyl)chromane-6-carbohydrazide	≥ 935 g/kgThe following relevant impurity must not exceed a certain threshold in the technical material:Butyl acetate (n-buthyl acetate, CAS No 123-86-4): ≤ 8 g/kg	1 April 2015	31 March 2025	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on chromafenozide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the risk to groundwater, if the substance is applied under vulnerable soil or climatic conditions;(b) the risk to non-target Lepidoptera in off-crop areas;(c) the risk to sediment-dwelling organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the non-significance of the difference between the material used for ecotoxicological testing and the agreed specification of the technical material for the risk assessment;(2) the assessment of the risk to sediment dwelling organisms from metabolite M-010;(3) the leaching potential of metabolites M-006 and M-023 to groundwater.The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under (1) by 30 September 2015 and under (2) and (3) by 31 March 2017.
82	Gamma-cyhalothrinCAS No 76703-62-3CIPAC No 768	(S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate or(S)-α-cyano-3-phenoxybenzyl (1R)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate	≥ 980 g/kg	1 April 2015	31 March 2025	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on gamma-cyhalothrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the safety of operators and workers;(b) the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) analytical methods for the monitoring of residues in body fluids, tissues and environmental matrices;(2) the toxicity profile of the metabolites CPCA, PBA and PBA(OH);(3) the long-term risk to wild mammals;(4) the potential for biomagnification in terrestrial and aquatic food chains.The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 31 March 2017.
83	Bacillus amyloliquefaciens subsp. plantarum strain D747Accession number in the Agricultural Research Culture Collection (NRRL), Peoria, Illinois, USA: B-50405Deposit number in the International Patent Organism Depositary, Tokyo, Japan: FERM BP-8234.	Not applicable	Minimum concentration: 2,0 × 10¹¹ CFU/g	1 April 2015	31 August 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus amyloliquefaciens subsp. plantarum strain D747, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators and workers, taking into account that Bacillus amyloliquefaciens subsp. plantarum strain D747 is to be considered as a potential sensitizer. Conditions of use shall include risk mitigation measures, where appropriate.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
84	Terpenoid blend QRD 460CIPAC No: 982	Terpenoid blend QRD 460 is a blend of three components:α-terpinene: 1-isopropyl-4-methylcyclohexa-1,3-diene;p-cymene: 1-isopropyl-4-methylbenzene;d-limonene: (R)-4-isopropenyl-1-methylcyclohexene.	The nominal concentration of each component in the active substance as manufactured should be as follows:α-terpinene: 59,7 %;p-cymene: 22,4 %;d-limonene: 17,9 %.Each component should have a minimum purity as follows:α-terpinene: 89 %;p-cymene: 97 %;d-limonene: 93 %.	10 August 2015	10 August 2025	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on terpenoid blend QRD-460, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the stability of formulations on storage;(b) the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;(c) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;(d) the protection of surface water and aquatic organisms;(e) the protection of bees and non-target arthropods.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the technical specification of the active substance as manufactured (5 batch analysis for the blend should be provided), supported by acceptable and validated methods of analysis. It should be confirmed that there are no relevant impurities present in the technical material;(2) the equivalence of the material used in the toxicological and ecotoxicological studies with the confirmed technical specification.The applicant shall submit that information to the Commission, the Member States and the Authority by 10 February 2016.
85	FenhexamidCAS No: 126833-17-8CIPAC No: 603	N-(2,3-dichloro-4-hydroxyphenyl)-1-methylcyclohexane-1-carboxamide	≥ 975 g/kgThe following relevant impurity must not exceed a certain threshold in the technical material:toluene: max. 1 g/kg,4-amino-2,3-dichlorophenol: max. 3 g/kg.	1 January 2016	31 December 2030	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenhexamid, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators during field crop handheld operations,the protection of workers re-entering indoor-treated crops,the risk to aquatic organisms,the long-term risk to mammals for field uses.Conditions of use shall include risk mitigation measures, where appropriate.
86	Halauxifen-methylCAS No:943831-98-9CIPAC No: 970.201 (halauxifen-methyl) 970 (halauxifen)	methyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)pyridine-2-carboxylate	≥ 930 g/kg	5 August 2015	5 January 2028	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on halauxifen-methyl, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:The risk to aquatic and non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:The technical specification of the active substance as manufactured (based on commercial scale production). The relevance of impurities present in the technical material should be confirmed,The compliance of the toxicity batches with the technical specification.The applicant shall submit that information to the Commission, the Member States and the Authority by 5 February 2016.
87	PyridateCAS No: 55512-33-9CIPAC No: 447	O-6-chloro-3-phenylpyridazin-4-yl S-octyl thiocarbonate	≥ 900 g/kg	1 January 2016	31 December 2030	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyridate, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, non-target terrestrial plants, and herbivorous mammals.Conditions of use shall include risk mitigation measures, where appropriate.
88	SulfoxaflorCAS No: 946578-00-3CIPAC No: 820	[methyl(oxo){1-[6-(trifluoromethyl)-3-pyridyl]ethyl}-λ⁶-sulfanylidene]cyanamide	≥ 950 g/kg	18 August 2015	18 January 2028	Only uses in permanent greenhouses may be authorised.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sulfoxaflor, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 29 May 2015 and updated on 28 January 2022, shall be taken into account.In this overall assessment, Member States shall pay particular attention to the risk to bees and bumble bees released for pollination, when products containing the substance are applied in greenhouses.Conditions of use shall include risk mitigation measures, where appropriate.
89	SulfosulfuronCAS No: 141776-32-1CIPAC No: 601	1-(4,6-dimethoxypyrimidin-2-yl)-3-(2-ethylsulfonylimidazo[1,2-a]pyridine-3-ylsulfonyl)urea	≥ 980 g/kgThe following relevant impurity must not exceed a certain threshold in the technical material:Phenol: < 2 g/kg	1 January 2016	31 December 2030	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sulfosulfuron, and in particular Appendices I and II thereof shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;the risk to soil non-target macro-organisms other than earthworms, non-target terrestrial plants and aquatic organisms.
90	FlorasulamCAS No 145701-23-1CIPAC No 616	2′,6′,8-trifluoro-5-methoxy[1,2,4]triazolo[1,5-c]pyrimidine-2-sulfonanilide	≥ 970 g/kgImpurity: 2,6-DFA, not more than 2 g/kg	1 January 2016	31 December 2030	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on florasulam, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms and non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.
91	FlupyradifuroneCAS No: 951659-40-8CIPAC No: 987	4-[(6-chloro-3-pyridylmethyl)(2,2-difluoroethyl) amino]furan-2(5H)-one	≥ 960 g/kg	9 December 2015	9 June 2029	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flupyradifurone, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of workers and operators,the risk to non-target arthropods, aquatic invertebrates and small herbivorous mammals,the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions,residues in animal matrices and rotational crops.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of some individual impurities,(2) the compliance of the toxicity batches with the confirmed technical specification,(3) the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water.The applicant shall submit to the Commission, the Member States and the Authority the information requested under point (1) and (2) by 9 June 2016, the information requested under point (3) within 2 years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
92	RescalureCAS No: 67601-06-3CIPAC No:Not available	(3S,6R)-(3S,6S)-6-isopropenyl-3-methyldec-9-en-1-yl acetate	≥ 750 g/kgThe ratio of (3S,6R)/(3S,6S) shall be in a range of 55/45 to 45/55. The purity range for each isomer shall be 337,5 g/kg to 412,5 g/kg.	18 December 2015	18 May 2028	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on rescalure, and in particular Appendices I and II thereof, shall be taken into account.
93	MandestrobinCAS No: 173662-97-0CIPAC No: Not available	(RS)-2-methoxy-N-methyl-2-[α-(2,5-xylyloxy)-o-tolyl]acetamide	≥ 940 g/kg (on a dry weight basis)Xylenes (ortho, meta, para), ethyl benzene max. 5 g/kg (TK)	9 December 2015	9 June 2029	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mandestrobin, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to aquatic organisms,the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of some individual impurities;(2) the compliance of the toxicity batches with the confirmed technical specification.The applicant shall submit that information to the Commission, the Member States and the Authority by 9 June 2016.
94	2,4-DCAS No: 94-75-7CIPAC No: 1	(2,4-dichlorophenoxy) acetic acid	≥ 960 g/kgImpurities:Free phenols (expressed as 2,4-DCP): not more than 3 g/kg.Sum of dioxins and furans (WHO-TCDD TEQ): not more than 0,01 mg/kg.	1 January 2016	31 December 2030	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 2,4-D, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, terrestrial organisms and consumers in cases of uses above 750 g/ha.Conditions of use shall include risk mitigation measures, where appropriate.The notifier shall submit to the Commission, the Member States and the Authority:(1) confirmatory information in the form of the submission of the complete study results from the existing extended one-generation study;(2) confirmatory information in the form of the submission of the Amphibian Metamorphosis Assay (AMA) (OECD (2009) Test No 231) as to verify the potential endocrine properties of the substance.The information set out in point (1) shall be submitted by 4 June 2016 and the information set out in point (2) by 4 December 2017.
95	Pyraflufen-ethylCAS No 129630-19-9CIPAC No 605.202	ethyl [2-chloro-5-(4-chloro-5-difluoromethoxy-1-methylpyrazol-3-yl)-4-fluorophenoxy]acetate	≥ 956 g/kg	1 April 2016	31 March 2031	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pyraflufen-ethyl, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of aquatic organisms,the protection of non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.
96	IprovalicarbCAS No 140923-17-7CIPAC No 620	isopropyl [(1S)-2-methyl-1-{[(1RS)-1-p-tolylethyl]carbamoyl}propyl]carbamate	≥ 950 g/kgImpurities:Toluene: not more than 3 g/kg	1 April 2016	31 March 2031	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on iprovalicarb, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of groundwater from the relevant soil metabolite PMPA when the active substance is applied in regions with low clay containing soil types,the safety of operators and workers,the protection of aquatic organisms in the case of formulated products containing other active substances.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority, confirmatory information as regards the genotoxic potential of soil metabolite PMPA. This information shall be submitted by 30 September 2016.
97	PinoxadenCAS No 243973-20-8CIPAC No 776	8-(2,6-diethyl-p-tolyl)-1,2,4,5-tetrahydro-7-oxo-7H-pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropionate	≥ 970 g/kgToluene max. content 1 g/kg	1 July 2016	31 December 2029	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on pinoxaden, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 29 January 2016 shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.The Member States concerned shall carry out monitoring programmes to verify potential groundwater contamination from the metabolite M2 in vulnerable zones, where appropriate.The applicant shall submit confirmatory information as regards:(a) a validated method of analysis of metabolites M11, M52, M54, M55 and M56 in ground water;(b) the relevance of the metabolites M3, M11, M52, M54, M55 and M56, and the corresponding groundwater risk assessment, if pinoxaden is classified under Regulation (EC) No 1272/2008 as H361d (suspected of damaging the unborn child).The applicant shall submit to the Commission, the Member States and the Authority the relevant information set out in point (a) by 30 June 2018 and the information set out in point (b) within six months from the notification of the classification decision under Regulation (EC) No 1272/2008 concerning pinoxaden.
98	Acibenzolar-S-methylCAS No 135158-54-2CIPAC No 597	S-methyl benzo[1,2,3]thiadiazole-7-carbothioate	970 g/kgToluene: max. 5 g/kg	1 April 2016	31 March 2031	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on acibenzolar-S-methyl, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the risk for consumers via food intake;(b) the protection of operators and workers;(c) the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall by 1 June 2017 submit to the Commission, the Member States and the Authority, confirmatory information as regards the relevance and reproducibility of the morphometric changes observed in the cerebellum of foetuses linked to exposure to acibenzolar-S-methyl and whether these changes may be produced via an endocrine mode of action. The information to be submitted shall includea systematic review of the available evidence assessed on the basis of available guidance (e.g. EFSA GD on Systematic Review methodology, 2010).
99	CyantraniliproleCAS No:736994-63-1CIPAC No: Not allocated.	3-bromo-1-(3-chloro-2-pyridyl)-4′-cyano-2′-methyl-6′-(methylcarbamoyl)pyrazole-5-carboxanilide	≥ 940 g/kgIN-Q6S09 max. 1 mg/kgIN-RYA13 max. 20 mg/kgmethanesulfonic acid max. 2 g/kgacetonitrile max. 2 g/kgheptane max. 7 g/kg3-picoline max. 3 g/kg.	14 September 2016	14 September 2026	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyantraniliprole, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the risk to operators;(b) the risk to aquatic organisms, bees and other non-target arthropods;(c) the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses;(d) the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water within 2 years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
100	IsofetamidCAS No: 875915-78-9CIPAC No: 972	N-[1,1-dimethyl-2-(4-isopropoxy-o-tolyl)-2-oxoethyl]-3-methylthiophene-2-carboxamide	≥ 950 g/kg	15 September 2016	15 September 2026	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on isofetamid, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to the risk to operators, workers and aquatic organisms, in particular fish.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:(1) the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;(2) the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification;(3) the effect of water treatment process chlorination on the nature of residues, including the potential for the formation of chlorinated residues that may be formed from residues present in surface water, when surface water is abstracted for drinking water.The applicant shall submit the information requested under points (1) and (2) by 15 March 2017 and the information requested under point (3) within 2 years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
101	Bacillus amyloliquefaciens strain MBI 600.Accession number in the National Collection of Industrial, Marine and Food Bacteria Ltd (NCIMB), Scotland: NCIMB 12376Deposit number in the American Type Culture Collection (ATCC): SD-1414	Not applicable	Minimum concentration:5,0 × 10¹⁴ CFU/kg	16 September 2016	16 September 2026	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Bacillus amyloliquefaciens strain MBI 600, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the specification of the technical material as commercially manufactured, including full characterisation of impurities and metabolites;(b) the protection of operators and workers, taking into account that Bacillus amyloliquefaciens strain MBI 600 is to be considered as a potential sensitiser.Conditions of use shall include risk mitigation measures, where appropriate.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.
102	EthofumesateCAS No 26225-79-6CIPAC No 233	(RS)-2-ethoxy-2,3-dihydro-3,3-dimethylbenzofuran-5-yl methanesulfonate	≥ 970 g/kgThe following impurities are of toxicological concern and must not exceed the following levels in the technical material:EMS; ethyl methane sulfonate: maximum of 0,1 mg/kgiBMS; iso-butyl methane sulfonate: maximum of 0,1 mg/kg	1 November 2016	31 October 2031	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on ethofumesate, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.
103	PicolinafenCAS No 137641-05-5CIPAC No 639	4′-fluoro-6-(α,α,α-trifluoro-m-tolyloxy)pyridine-2-carboxanilide	≥ 980 g/kg	1 November 2016	30 June 2031	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on picolinafen, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the impurities in the technical active substance;the protection of mammals, especially of large herbivorous mammals;the protection of non-target terrestrial plants;the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;the protection of aquatic organisms, especially to algae.Conditions of use shall include risk mitigation measures, where appropriate.
104	Thifensulfuron-methylCAS No 79277-27-3CIPAC No 452	methyl 3-(4-methoxy-6-methyl-1,3,5-triazin-2-ylcarbamoylsulfamoyl)thiophene-2-carboxylate	≥ 960 g/kg	1 November 2016	31 October 2031	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thifensulfuron-methyl, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of groundwater;the protection of non-target plants and aquatic organisms.Conditions of use shall include risk mitigation measures and the obligation to monitor the groundwater, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:(1) the absence of genotoxicity of metabolites IN-A4098 and its derivative IN-B5528, IN-A5546 and IN-W8268;(2) mechanistic data to rule out an endocrine mediated mode of action for mammary gland tumours;(3) the risk to aquatic organisms from thifensulfuron-methyl and metabolite IN-D8858 and the risk to soil organisms from metabolites IN-JZ789 and 2 acid 3 triuret;(4) the relevance of the metabolites IN-A4098, IN-L9223 and IN-JZ789 if thifensulfuron-methyl is classified as reprotoxic category 2 under Regulation (EC) No 1272/2008 and the risk that those metabolites contaminate groundwater.The applicant shall submit the information requested under point (1) by 31 March 2017, under points (2) and (3) by 30 June 2017 and under point (4) within six months after the notification of the classification decision concerning thifensulfuron-methyl.
105	Thiabendazole	2-(thiazol-4-yl)benzimidazole	≥ 985 g/kg	1 April 2017	31 March 2032	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on thiabendazole, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and consumers,the protection of groundwater,the control of waste water from post-harvest uses.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit by 31 March 2019 to the Commission, the Member States and the Authority confirmatory information regarding Level 2 tests as currently indicated in the OECD Conceptual Framework investigating the potential for endocrine-mediated effects of thiabendazole.
CAS No 148-79-8CIPAC No 323
106	OxathiapiprolinCAS No:1003318-67-9CIPAC No: 985	1-(4-{4-[(5RS)-5-(2,6-difluorophenyl)-4,5-dihydro-1,2-oxazol-3-yl]-1,3-thiazol-2-yl}-1-piperidyl)-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]ethanone	≥ 950 g/kg	3 March 2017	3 March 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on oxathiapiprolin, and in particular Appendices I and II thereof, shall be taken into account.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:(1) the technical specification of the active substance as manufactured (based on commercial scale production) including the relevance of impurities;(2) the compliance of the toxicity and ecotoxicity batches with the confirmed technical specification.The applicant shall submit the information requested under points (1) and (2) by 3 September 2017.
107	IodosulfuronCAS No 185119-76-0 (parent)CAS No 144550-36-7 (iodosulfuron-methyl-sodium)CIPAC No 634 (parent)CIPAC No 634.501 (iodosulfuron-methyl-sodium)	4-iodo-2-[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)carbamoylsulfamoyl]benzoic acid(iodosulfuron)sodium ({[5-iodo-2-(methoxycarbonyl)phenyl]sulfonyl}carbamoyl)(4-methoxy-6-methyl-1,3,5-triazin-2-yl)azanide(iodosulfuron-methyl-sodium)	≥ 910 g/kg (expressed as iodosulfuron-methyl-sodium)	1 April 2017	31 March 2032	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on iodosulfuron, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to consumers,the risk to non-target terrestrial plants,the risk to aquatic plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:(1) the genotoxic potential of the metabolite triazine-amine (IN-A4098), in order to confirm that this metabolite is not genotoxic and not relevant for the risk assessment;(2) the effect of water treatment processes on the nature of residues present in drinking water.The applicant shall submit the information requested under point (1) 1 October 2017 and the information requested under point (2) by two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
108	FlazasulfuronCAS No 104040-78-0CIPAC No 595	1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-trifluoromethyl-2-pyridylsulphonyl)urea	≥ 960 g/kg	1 August 2017	31 July 2032	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on flazasulfuron, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of aquatic plants,the protection of non-target terrestrial plants,the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water within a period of two years a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.
109	Beauveria bassiana strain NPP111B005Accession number in the CNCM (Collection Nationale de Culture de Microorganismes) — Institut Pasteur, Paris, France: I-2961.	Not applicable	Max. level of beauvericin 24 μg/L	7 June 2017	7 June 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria bassiana strain NPP111B005, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers, taking into account that Beauveria bassiana strain NPP111B005 is to be considered, as any micro-organism, as a potential sensitizer, and paying special attention to exposure through inhalation,the maximum level of the metabolite beauvericin in the formulated product.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.Conditions of use shall include risk mitigation measures, where appropriate.
110	Beauveria bassiana strain 147Accession number in the CNCM (Collection nationale de cultures de micro-organismes) — Institut Pasteur, Paris, France: I-2960.	Not applicable	Max. level of beauvericin: 24 μg/L	6 June 2017	6 June 2027	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria bassiana strain 147, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers, taking into account that Beauveria bassiana strain 147 is to be considered, as any micro-organism, as a potential sensitizer, and paying special attention to exposure through inhalation,the maximum level of the metabolite beauvericin in the formulated product.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer.Conditions of use shall include risk mitigation measures, where appropriate.
111	Mesosulfuron (parent)Mesosulfuron-methyl (variant)CAS No 208465-21-8(mesosulfuron-methyl)CIPAC No 663(mesosulfuron)CIPAC No 663.201(mesosulfuron-methyl	Mesosulfuron-methyl:methyl-2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-α-(methanesulfonamido)-p-toluateMesosulfuron:2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl)sulfamoyl]-α-methanesulfonamido-p-toluic acid	≥ 930 g/kg(expressed as mesosulfuron-methyl)	1 July 2017	30 June 2032	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on mesosulfuron and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of aquatic organisms and non-target terrestrial plants;the protection of groundwater.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water within a period of two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.
112	MesotrioneCAS No 104206-82-8CIPAC No 625	Mesotrione2-(4-mesyl-2-nitrobenzoyl) cyclohexane -1,3-dione	≥ 920 g/kgR287431 max 2 mg/kgR287432 max 2 g/kg1,2-dichloroethane max 1 g/kg	1 June 2017	31 May 2032	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on mesotrione, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators,the protection of groundwater in vulnerable regions,the protection of mammals, aquatic and non-target plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:1. the genotoxic profile of the metabolite AMBA;2. the potential endocrine disrupting mode of action of the active substance in particular level 2 and 3 tests, currently indicated in the OECD Conceptual framework (OECD 2012) and analysed in the EFSA Scientific opinion on the hazard assessment of endocrine disruptors;3. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water.The applicant shall submit to the Commission, the Member States and the Authority the relevant information requested under point 1 by 1 July 2017 and the relevant information requested under point 2 by 31 December 2017. The applicant shall submit to the Commission, the Member States and the Authority the confirmatory information requested under point 3 within a period of two years after a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.
113	Cyhalofop-butylCAS No 122008-85-9CIPAC No 596	butyl (R)-2-[4-(4-cyano-2-fluorophenoxy) phenoxy]propionate	950 g/kg	1 July 2017	30 June 2032	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on cyhalofop-butyl, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators,the technical specification,the protection of non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.
114	Propoxycarbazone (parent)Propoxycarbazone-sodium (variant)CAS No 145026-81-9 (propoxycarbazone)CAS No 181274-15-7 (propoxycarbazone-sodium)CIPAC No 655 (propoxycarbazone)CIPAC No 655.011 (propoxycarbazone-sodium)	Propoxycarbazone:methyl 2-[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazole-1-carboxamido)sulfonyl]benzoatePropoxycarbazone-sodium:sodium {[2-(methoxycarbonyl)phenyl]sulfonyl}[(4,5-dihydro-4-methyl-5-oxo-3-propoxy-1H-1,2,4-triazol-1-yl)carbonyl]azanide	≥ 950g/kg(expressed as Propoxycarbazone-sodium)	1 September 2017	31 August 2032	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on propoxycarbazone, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of aquatic organisms, in particular aquatic plants and of and non-target terrestrial plants,the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water within a period of 2 years of a guidance document on the evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.
115	Benzoic acidCAS No 65-85-0CIPAC No 622	Benzoic acid	≥ 990 g/kg	1 September 2017	31 August 2032	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on benzoic acid and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to the protection of operators, ensuring that conditions of use impose the use of adequate personal protective equipment.Conditions of use shall include risk mitigation measures, where appropriate.
116	2,4-DBCAS No 94-82-6CIPAC No 83	4-(2,4-dichlorophenoxy) butyric acid	≥ 940 g/kgImpurities:Free phenols (expressed as 2,4-dichlorophenol (2,4-DCP)): max. 15 g/kg.Dibenzo-p-dioxins and polychlorinated dibenzofurans (TCDD toxic equivalents (TEQ)): max. 0,01 mg/kg.	1 November 2017	31 October 2032	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 2,4-DB, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers,the protection of consumers from products of animal origin,the protection of wild mammals,the protection of soil non-target organisms,the protection of aquatic organisms,the protection of non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.
117	Maleic hydrazideCAS No 123-33-1CIPAC No 310	6-hydroxy-2H-pyridazin-3-one	≥ 979 g/kgThe impurity hydrazine shall not exceed 0,028 mg/kg in the technical material.	1 November 2017	31 October 2032	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on maleic hydrazide, and in particular Appendices I and II thereto, as well as its addendum, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of consumers;the operator and worker safety; the conditions of the use shall include the application of adequate personal protective equipment.Conditions of use shall include risk mitigation measures, where appropriate.
118	GlyphosateCAS No: 1071-83-6CIPAC No: 284	N-(phosphonomethyl)glycine	≥ 950 g/kgThe following impurities are of toxicological concern and shall not exceed the following levels in the technical material:N-nitroso-glyphosate (NNG): &amp;amp;amp;lt; 1 mg/kgformaldehyde: < 1 g/kgtriethylamine: ≤ 2g/kgformic acid: ≤ 4 g/kgN,N-bis(phosphonomethyl) glycine (glyphosine): ≤ 3 g/kg	16 December 2023	15 December 2033	Only uses as herbicide may be authorised.For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on glyphosate, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the co-formulants present in glyphosate-containing plant protection products, taking into account in particular the criteria for identification of unacceptable co-formulants as set out in Commission Implementing Regulation (EU) 2023/574;the consumer exposure assessment with regards to residues that may be present in succeeding crops grown in rotation;the protection of groundwater in vulnerable areas and of surface waters, in particular those used for the abstraction of drinking water, considering specifically uses on sealed surfaces;the protection of small herbivorous mammals. Member States shall, where considered necessary impose mitigation measures such as limiting the timing of use, the number of applications or the maximum dose rate. The following maximum application rates shall not be exceeded unless the outcome of the risk assessment undertaken for the specific uses for which authorisation is applied for demonstrates that a higher rate does not lead to any unacceptable effects on small herbivorous mammals:For use in agriculture: 1,44 kg glyphosate per hectare, per year;For use to control invasive species in agricultural and non-agricultural areas: 1,8 kg glyphosate per hectare, per year;For use in non-agricultural areas: 3,6 kg glyphosate per hectare, per year;the protection of non-target terrestrial and aquatic plants from exposure by spray drift;indirect effects on biodiversity via trophic interactions once relevant methods and guidance to identify such effects are agreed at Union level. In the absence of such methods and guidance, Member States may apply methods which they consider appropriate to determine the potential indirect effects of plant protection products containing glyphosate and which take into account their local agro-environmental conditions. When doing so, if they identify any such possible indirect effects on biodiversity, Member States shall set specific conditions or restrictions of use for plant protection products containing glyphosate, considering in particular if practical alternative control or prevention methods with lower impacts on biodiversity are available;uses by non-professional users;compliance of pre-harvest uses with the provisions of Directive 2009/128/EC in conjunction with Article 55 of Regulation (EC) No 1107/2009. Uses for desiccation to control the time point of harvest or to optimise threshing shall not be authorised.Conditions of use shall include risk mitigation measures, including combinations thereof, as required. In particular, drift shall be reduced for spray applications made by professional users in agricultural fields. By default, to protect non-target terrestrial plants, an in-field non-sprayed buffer strip of at least 5 to 10 m from the field border depending on the particular use and drift reduction nozzles reducing spray drift by at least 75 %, or other risk mitigation measures with equivalent reduction of drift, shall be required, unless the outcome of the risk assessment undertaken for the specific plant protection product use indicates that such risk mitigation measures are not needed or can be lowered because there are no unacceptable risks caused by spray drift.In addition, Member States may set monitoring requirements when granting authorisations, in order to complement the monitoring under Directive 2000/60/EC of the European Parliament and of the Council^note and Directive 2009/128/EC.Member States shall ensure that use of plant protection products containing glyphosate is minimised or prohibited in the specific areas listed in Article 12(a) of Directive 2009/128/EC.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the possible indirect effects on biodiversity via trophic interactions, within three years from the date of applicability of a relevant guidance document endorsed by the Standing Committee on Plants, Animals, Food and Feed.
119	AcetamipridCAS No 135410-20-7CIPAC No 649	(E)-N1-[(6-Chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamidine	≥ 990 g/kg	1 March 2018	28 February 2033	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on acetamiprid, and in particular Appendices I and II thereof, shall be taken into account.In their overall assessment Member States shall pay particular attention to:the risk to aquatic organisms, bees and other non-target arthropods,the risk to birds and mammals,the risk to consumers,the risk to operators.Conditions of use shall include risk mitigation measures, where appropriate.
120	BentazoneCAS No 25057-89-0CIPAC No 366	3-isopropyl-1H-2,1,3-benzothiadiazin-4(3H)-one 2,2- dioxide	≥ 960 g/kg1,2-dichloroethane < 3 mg/kg	1 June 2018	31 October 2027	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bentazone, and in particular Appendices I and II thereof, shall be taken into account.In their overall assessment Member States shall pay particular attention to:the technical specification,the protection of operators and workers,the risk to birds and mammals,the protection of groundwater, particularly but not only in drinking water protected areas, and shall carefully consider the timing of application, soil and/or climatic conditions.Conditions of use shall include risk mitigation measures where appropriate.The applicant shall submit by 1 February 2019 to the Commission, the Member States and the Authority confirmatory information as regards Level 2/3 tests as currently indicated in the OECD Conceptual Framework investigating the potential for endocrine-mediated effects of bentazone.
121	SilthiofamCAS No 175217-20-6CIPAC No 635	N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide	≥ 980 g/kg	1 July 2018	30 June 2033	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on silthiofam and in particular Appendices I and II thereof, shall be taken into account.In their overall assessment Member States shall pay particular attention to:the protection of operators,the protection of groundwater in vulnerable regions,the protection of birds, mammals and earthworms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:1. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater are abstracted for drinking water;2. the relevance of the metabolites M2 and M6 taking into account any relevant classification for silthiofam in accordance with Regulation (EC) No 1272/2008, in particular as reprotoxic category 2.The applicant shall submit the information mentioned in point (1) within two years after a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater is made public by the Commission and the information requested under point (2) within one year after the publication in the European Chemicals Agency (ECHA) webpage of the opinion adopted by the Committee for risk assessment of the ECHA in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to silthiofam.
122	ForchlorfenuronCAS No 68157-60-8CIPAC No 633	1-(2-chloro-4-pyridyl)-3-phenylurea	≥ 978 g/kg	1.6.2018	31.5.2033	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on forchlorfenuron, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to consumers as regards the potential risk from metabolites in fruit crops with edible peels.Conditions of use shall include risk mitigation measures, where appropriate.
123	ZoxamideCAS No 156052-68-5CIPAC No 640	(RS)-3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-p-toluamide	≥ 953 g/kg	1 July 2018	30 June 2033	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on zoxamide, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of groundwater from metabolite RH-141455,the protection of bees, aquatic organisms and earthworms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater is made public by the Commission.
124	TrifloxystrobinCAS No 141517-21-7CIPAC No 617	methyl (E)-methoxyimino-{(E)-α-[1-(α,α,α-trifluoro-m-tolyl)ethylideneaminooxyl]-o-tolyl}acetate	≥ 975 g/kgAE 1344136 (max. 4 g/kg)	1 August 2018	31 July 2033	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on trifloxystrobin, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions;the protection of aquatic organisms, bees, and of fish-eating birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:(1) the relevance of metabolites that may occur in groundwater, taking into account any relevant classification for trifloxystrobin in accordance with Regulation (EC) No 1272/2008, in particular as toxic for reproduction category 2;(2) the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water.The applicant shall submit the information requested under point (1) within one year after the publication, on the website of the European Chemicals Agency (ECHA), of the opinion adopted by the Committee for Risk Assessment of the ECHA in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to trifloxystrobin.The applicant shall submit the information requested under point (2) within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.
125	Carfentrazone-ethylCAS No 128639-02-1CIPAC No 587.202	Ethyl (RS)-2-chloro-3-[2-chloro-4-fluoro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H- 1,2,4-triazol-1-yl]phenyl]propionate	≥ 910 g/kg	1 August 2018	31 July 2033	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on carfentrazone-ethyl, and in particular Appendices I and II thereof, shall be taken into account.In their overall assessment Member States shall pay particular attention to:the protection of groundwater when the substance is applied in regions with vulnerable soil and/or climate conditions;the protection of soil non-target organisms;the protection of aquatic organisms;the protection of non-target terrestrial higher plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:(1) the relevance of metabolites that may occur in groundwater, taking into account any relevant classification for carfentrazone-ethyl in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council, in particular as carcinogen category 2;(2) the effect of water treatment processes on the nature of residues present in drinking water.The applicant shall submit the information mentioned in point (1) within one year after the publication on the website of the European Chemicals Agency of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) of Regulation (EC) No 1272/2008 with respect to carfentrazone-ethyl.The applicant shall submit the information requested under point (2) within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.
126	FenpicoxamidCAS No: 517875-34-2CIPAC No: 991	(3S,6S,7R,8R)-8-benzyl-3-{3-[(isobutyryloxy)methoxy]-4-methoxypyridine-2-carboxamido}-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl isobutyrate	≥ 750 g/kg	11 October 2018	11 October 2028	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fenpicoxamid, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the impact of processing on the consumer risk assessment,the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:1. the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification;2. the effect of water treatment processes on the nature of residues present in drinking water;3. the endocrine disrupting potential of fenpicoxamid as regards the thyroid modality/pathway, providing in particular mechanistic data to clarify according to Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605, whether the effects observed in the studies submitted for approval are or are not related to a thyroid endocrine disrupting mode of action.The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 1 by 11 October 2019, in point 2 within 2 years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission and in point 3 by 10 November 2020.
127	PethoxamidCAS No 106700-29-2CIPAC No 665	2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide	≥ 940 g/kgImpurities:Toluene: max 3 g/kg.	1 December 2018	30 November 2033	PART AUse shall be limited to one application every two years in the same field at a maximum dose of 1200 g active substance per hectare.PART BFor the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pethoxamid, and in particular Appendices I and II thereto, shall be taken into account.In their overall assessment Member States shall pay particular attention to:the risk of groundwater metabolites when pethoxamid is applied in regions with vulnerable soil and/or climatic conditions;the risk to aquatic organisms and earthworms;the risk to consumers from residues in the succeeding crops or in case of crop failure.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:1. the relevance of the metabolites that may occur in groundwater, taking into account any relevant classification for pethoxamid in accordance with Regulation (EC) No 1272/2008 of the Parliament and of the Council, in particular as carcinogen category 2;2. the effect of water treatment processes on the nature of residues present in drinking water;3. the endocrine disrupting potential of pethoxamid as regards the thyroid modality/pathway as a minimum providing mechanistic data to clarify whether there is a thyroid endocrine disrupting mode of action.The applicant shall submit the information requested under point 1 within one year after the publication of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) Regulation (EC) No 1272/2008 of the European Parliament and of the Council with respect to pethoxamid and the information requested.The applicant shall submit the information requested under point 2 within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.The applicant shall submit the information requested under point 3 by 10 November 2020 in accordance with Commission Regulation (EU) 2018/605^note amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties and the joint guidance document to identify endocrine disrupting substances as adopted by EFSA and ECHA.
128	Tribenuron (parent)CAS No 106040-48-6CIPAC No 546	2-[[(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-methylcarbamoyl]sulfamoyl]benzoic acid	≥ 960 g/kg (expressed as tribenuron-methyl)	1 February 2019	30 January 2034	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on tribenuron, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of consumers, in particular to residues on animal products,the protection of groundwater,the protection of aquatic organisms and of non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.
129	Metschnikowia fructicola strain NRRL Y-27328Accession number in the Agriculture Research Service Culture Collection at the National center for agricultural utilisation research in Peoria, Illinois USA	Not applicable	Minimum concentration:1 × 10¹⁰ CFU/g	27 December 2018	27 December 2028	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Metschnikowia fructicola strain NRRL Y-27328, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers, taking into account that Metschnikowia fructicola strain NRRL Y-27328 is to be considered as a potential sensitizer.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be ensured by the producer.Conditions of use shall include risk mitigation measures, where appropriate.
130	Beauveria bassiana strain IMI389521Accession number in the CABI Genetic Resource Collection: IMI389521	Not applicable	Max. level of beauvericin: 0,09 mg/kg	19 February 2019	19 February 2029	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria bassiana strain IMI389521, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the storage stability of the formulation(s) containing B. bassiana strain IMI389521 including the level of the metabolite beauvericin content after storage;the content of the metabolite beauvericin produced under the application conditions;the risk posed by beauvericin in infected insects present in the stored grain. Measures are required to ensure that such products do not enter the food and feed chain, taking into account the natural background level of beauvericin on cereal grains;the protection of operators and workers, taking into account that B. bassiana strain IMI389521 is to be considered, as any micro-organism, as a potential sensitiser.The compliance with strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012^note.Conditions of use shall include risk mitigation measures where appropriate.
131	Beauveria bassiana strain PPRI 5339Accession number in the Agricultural Research Culture Collection (NRRL) International Depositary Authority: NRRL 50757	Not applicable	Max. level of beauvericin: 0,5 mg/kg	20 February 2019	20 February 2029	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria bassiana strain PPRI 5339, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the level of the metabolite beauvericin content in a shelf-life study after storage of the formulation(s) containing B. bassiana strain PPRI 5339;the effects on pollinators introduced in glasshouses following exposure to formulation(s) different from the representative one supporting this approval;the protection of operators and workers, taking into account that B. bassiana strain PPRI 5339 is to be considered, as any micro-organism, as a potential sensitizer.The compliance with strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012^note.Conditions of use shall include risk mitigation measures where appropriate.
132	MefentrifluconazoleCAS No: 1417782-03-6CIPAC No: Not assigned	(2RS)-2-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-1-(1H-1,2,4-triazol-1-yl)propan-2-ol	≥ 970 g/kgThe impurity N, N-dimethylformamide shall not exceed 0,5 g/kg in the technical material.The impurity toluene shall not exceed 1 g/kg in the technical materialThe impurity 1,2,4-(1H)-triazole shall not exceed 1 g/kg in the technical material	20 March 2019	20 March 2029	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on mefentrifluconazole, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment;the protection of aquatic organisms.Conditions of use shall include risk mitigation measures, such as buffer zones and/or vegetative strips, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:1. the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification;2. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water.The applicant shall submit the information referred to in point 1 by 20 March 2020 and the information referred to in point 2 within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
133	FlutianilCAS No [958647-10-4]CIPAC No 835	(Z)-[3-(2-methoxyphenyl)-1,3-thiazolidin-2-ylidene](α,α,α,4-tetrafluoro-m-tolylthio)acetonitrile	≥ 985 g/kg	14 April 2019	14 April 2029	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on flutianil, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers,the risk to aquatic organisms,the risk to groundwater from metabolites, if the substance is applied under vulnerable soil or climatic conditions.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:1. the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification;2. the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water;3. an updated assessment of the information submitted and, where relevant further information, confirming that flutianil is not an endocrine disruptor in accordance with Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, applying also the ECHA and EFSA guidance for identification of endocrine disruptors.The applicant shall submit the information:referred to in point 1 by 14 April 2020;referred to in point 2 within two years from the date of publication, from the Commission, of a guidance document on the evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater; andreferred to in point 3 by 14 April 2021.
134	IsoxaflutoleCAS No 141112-29-0CIPAC No 575	(5-cyclopropyl-1,2-oxazol-4-yl)(α,α,α-trifluoro-2-mesyl-p-tolyl)methanone	≥ 972 g/kg	1 August 2019	31 July 2034	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on isoxaflutole, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment, Member States shall pay particular attention to:the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions,the protection of aquatic organisms, wild mammals and non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or groundwater is abstracted for drinking water. The applicant shall submit this information within 2 years from the date of publication, by the Commission, of a guidance document on the evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.The applicant shall also provide an updated assessment to confirm that isoxaflutole is not an endocrine disruptor within the meaning of points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 and in accordance with the guidance for identification of endocrine disruptors^note by 10 May 2021.
135	carvone2244-16-8 (d-carvone = S-carvone = (+)-carvone)Carvone: 602d-carvone: not allocated	(S)-5-isopropenyl-2-methylcyclohex-2-en-1-oneOr(S)-p-mentha-6,8-dien-2-one	923 g/kg d-carvone	1 August 2019	31 July 2034	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on carvone, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment.Conditions of use shall include risk mitigation measures, where appropriate. In particular, consideration should be given to the necessary time period before entry into storage rooms after the application of plant protection products containing carvone.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water is abstracted for drinking water.The applicant shall submit that information within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
136	1-methylcyclopropeneCAS No 3100-04-7CIPAC No 767	1-methylcyclopropene	≥ 980 g/kg (technical concentrate)The following impurities are of toxicological concern and must not exceed the following levels in the technical material (technical concentrate):1-chloro-2-methylpropene: maximum of 0,2 g/kg,3-chloro-2-methylpropene: maximum of 0,2 g/kg.For 1-methylcyclopropene generated in situ, Heptane and methylcyclohexane are toxicologically relevant impurities. These impurities should remain below 10 %.	1 August 2019	31 July 2034	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 1-methylcyclopropene, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of groundwater, when the substance is applied in regions with vulnerable soil and climatic conditions.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the presence of methallyl alcohol in soil and aquatic compartments and, if formed in relevant amounts, information on its toxicological properties and potential risk to aquatic and soil organisms and as regards the effect of water treatment processes on the nature of residues present in drinking water. The confirmatory information shall be submitted by 27 May 2027.
137	Dimethenamid-PCAS No 163515-14-8CIPAC No 638	(S)-2-chloro-N-(2,4-dimethyl-3-thienyl)-N-(2-methoxy1-methylethyl)acetamide	≥ 930 g/kgThe following impurity is of toxicological concern and must not exceed the following level in the technical material:1,1,1,2-Tetrachloroethane (TCE): ≤ 1,0 g/kg	1 September 2019	31 August 2034	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on dimethenamid-P, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment;the protection of groundwater, in particular regarding the metabolites of dimethenamid-P;the protection of aquatic organisms and small herbivorous mammals.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water or ground water is abstracted for drinking water.The applicant shall submit the requested information within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
138	Tolclofos-methylCAS No 57018-04-9CIPAC No 479	O-2,6-dichloro-p-tolylO, O-dimethyl phosphorothioateO-2,6-dichloro-4-methylphenyl O, O-dimethyl phosphorothioate	≥ 960 g/kgThe following impurity is of toxicological concern and must not exceed the following level in the technical material:Methanol max. 1 g/kg	1 September 2019	31 August 2034	Only for use on ornamentals and on potatoes.For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on tolclofos-methyl, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to aquatic organisms and mammals,the risk to consumers, in particular the potential risk from metabolite DM-TM-CH2OH in potatoes,the risk to operators, workers and bystanders;Conditions of use shall include risk mitigation measures, where appropriate.
139	Florpyrauxifen-benzylCAS No: 1390661-72-9CIPAC No: 990.227	benzyl 4-amino-3-chloro-6-(4-chloro-2-fluoro-3-methoxyphenyl)-5-fluoropyridine-2-carboxylate	≥ 920 g/kgThe impurity toluene shall not exceed 3 g/kg in the technical material.	24 July 2019	24 July 2029	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on 22 March 2019, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of aquatic and terrestrial non-target plants.Conditions of use shall include risk mitigation measures such as buffer zones and/or drift reduction nozzles, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine activity in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 by 24 July 2021.
140	Metalaxyl-MCAS No 70630-17-0 (R)CIPAC No 580	methyl N-(methoxyacetyl)-N-(2,6-xylyl)-D-alaninate	920 g/kgThe following relevant impurities shall not exceed a certain threshold:2,6-dimethylphenylamine:max. content 0,5 g/kg4-methoxy-5-methyl-5H-[1,2]oxathiole 2,2-dioxide:max. content 1 g/kg2-[(2,6-dimethyl-phenyl)-(2-methoxyacetyl)-amino]-propionic acid 1-methoxycarbonyl-ethyl ester):max. content 10 g/kg	1 June 2020	31 May 2035	When used for seed treatment where treated seeds are to be sown outdoors, Member States shall, impose appropriate restrictions concerning the sowing density and require the use of precision drilling equipment. A sowing density above 2000000 seeds/ha shall not be exceeded unless the outcome of the risk assessment undertaken for the specific uses for which authorisation is applied for demonstrates that a higher rate does not lead to any unacceptable effects on birds and mammals.For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on metalaxyl-M, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the specification of the technical material as commercially manufactured,the protection of operators and workers, ensuring that the conditions of use prescribe the use of adequate personal protective equipment, where appropriate,the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions,the protection of non-target arthropods, birds and mammals.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water, by 10 July 2026.
141	ForamsulfuronCAS No 173159-57-4CIPAC No 659	1-(4,6-dimethoxypyrimidin-2-yl)-3-[2-(dimethylcarbamoyl)-5-formamidophenylsulfonyl]urea	≥ 973 g/kg	1 June 2020	31 May 2035	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on foramsulfuron, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the risk to consumers and operators,the risk to aquatic organisms and non-target plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water, within two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
142	Pyriproxyfen.2-((1-(4-Phenoxyphenoxy)propan-2-yl)oxy)pyridine.CIPAC No: 715.CAS No: 95737-68-1.EC No (Einecs or ELINCS): 429-800-1	4-phenoxyphenyl (RS)-2(2-pyridyloxy) propyl ether	≥ 970 g/kg Max. impurity: Toluene5 g/Kg	1 August 2020	31 July 2035	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pyriproxyfen and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the dietary exposure of consumers to residues of pyriproxyfen,the protection of sediment-dwelling organisms and aquatic organisms,the protection of bees.As regards the protection of sediment-dwelling organisms and aquatic organisms, for outdoor use of the plant protection products containing pyriproxyfen Member States shall include in the specific conditions appropriate risk mitigation measures, e.g. no-spray buffer zones and/or spray drift reduction, to achieve a low risk for sediment-dwelling organisms and aquatic organisms.As regards the protection of bees, for outdoor use of plant protection products containing pyriproxyfen Member States shall include in the specific conditions a restriction of application to periods outside of the flowering of bee attractive crops, and appropriate risk mitigation measures, e.g. no-spray buffer zones and/or spray drift reduction, to achieve a low risk for bees and bee larvae.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in surface and groundwater, when surface water is abstracted for drinking water.The applicant shall submit the requested confirmatory information within two years from the date of publication, by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
143	Kieselgur (Diatomaceous earth)CAS No 61790-53-2CIPAC No 647	No IUPAC name exists for kieselgurOther synonyms:Diatomaceous earth,Diatomite	1000 g/kgMinimum content of amorphous silica of 800 g/kgThe following impurity is of toxicological concern and must not exceed the following level in the technical material:Crystalline silica with particle size below 10 μm – maximum of 1 g/kg	1 February 2021	31 January 2036	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on kieselgur (diatomaceous earth), and in particular Appendices I and II thereto, shall be taken into account.Member States shall pay particular attention to the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment, in particular respiratory protective equipment, and other risk mitigation measures, where appropriate.Only indoor use is permitted. Member States shall assess any extension of the use pattern beyond use in closed storage environments, in order to establish whether the proposed extensions of use fulfil the requirements of Article 29(1) of Regulation (EC) No 1107/2009 and of the uniform principles laid down in Regulation (EU) No 546/2011. Conditions of use shall include risk mitigation measures, where appropriate.
144	Garlic extract Marker components: diallylsulfide (DAS1), diallyldisulfide (DAS 2), diallyltrisulfide (DAS3), diallyltetrasulfide (DAS 4)CAS No 8000-78-08008-99-9CIPAC No 916	Garlic extract	1000 g/kg	1 March 2021	29 February 2036	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on garlic extract, and in particular Appendices I and II thereto, shall be taken into account.On the basis of the proposed and supported uses (as listed in Appendix II), the following issues have been identified as requiring particular and short term attention from all Member States, in the framework of any authorisations to be granted, varied or withdrawn, as appropriate:The risk to aquatic organisms.
145	Streptomyces strain K61	Not applicable	No relevant impurities	1 July 2021	30 June 2036	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Streptomyces strain K61 and in particular Appendices I and II thereto, shall be taken into account.Member States shall pay particular attention to the protection of operators and workers, taking into account that microorganisms are considered as potential sensitisers, and shall ensure that adequate personal protective equipment is included as a condition of use.Producers shall ensure strict maintenance of environmental conditions and quality control analysis during the manufacturing process as laid down in Working Document SANCO/12116/2012 as regards the limits on microbiological contamination^note.
146	CyazofamidCAS No: 120116-88-3CIPAC No: 653	4-chloro-2-cyano-N,N-dimethyl-5-p-tolylimidazole-1-sulfonamide	≥ 935 g/kg	01/08/2021	31/07/2036	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on cyazofamid, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the specification of the technical material as commercially manufactured;(b) the impact of processing on the consumer risk assessment;(c) the protection of non-target arthropods and earthworms.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:1. the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water;2. points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605.The applicant shall submit the requested information referred to in point 1 within two years from the date of publication by the Commission, of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.As regards point 2 the applicant shall provide an updated assessment of the information already submitted and, where relevant, further information to confirm the absence of endocrine activity by 16 June 2023
147	ClopyralidCAS No 1702-17-6CIPAC No 455	3,6-dichloropyridine-2-carboxylic acid or 3,6dichloropicolinic acid	≥ 950 g/kg	1 October 2021	30 September 2036	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on clopyralid, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the specification of the technical material as commercially manufactured;the protection of operators, ensuring that conditions of use for operators include the application of adequate personal protective equipment;possible presence of clopyralid residues in rotational crops;the possible transfer of clopyralid residues via compost or manure of animals whose feed originates from treated areas, to avoid damage to susceptible crops;the protection of groundwater under vulnerable conditions.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues present in drinking water.The applicant shall submit this information within two years after adoption of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater.
148	Purpureocillium lilacinum strain 251	Not applicable	No relevant impurities	1 March 2022	28 February 2037	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Purpureocillium lilacinum strain 251, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a) the strict maintenance of environmental conditions and quality control analysis during the manufacturing process to be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012;(b) the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use.Conditions of use shall include risk mitigation measures, where appropriate.
149	FlumioxazinCAS No 103361-09-7CIPAC No 578	N-(7-fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboximide	≥ 960 g/kg	1 March 2022	28 February 2037	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on flumioxazin, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the specification of the technical material that is authorised for use in plant protection products;the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;the protection of non-target plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority an updated assessment of the information submitted and, where relevant, further information to confirm the absence of endocrine disrupting properties in accordance with points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605^note by 1 March 2024.
150	Carbon dioxideCAS No: 124-38-9CIPAC No: 844	Carbon dioxide	999 g/kgThe following impurities are of toxicological concern and shall not exceed the following levels in the technical material:phosphane max. 0,3 ppm v/vbenzene max. 0,02 ppm v/vcarbon monoxide max. 10 ppm v/vmethanol max. 10 ppm v/vhydrogen cyanide max. 0,5 ppm v/vv	1 May 2022	30 April 2037	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on carbon dioxide, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:adequate ventilation (e.g. with a certificate of gas clearance) before humans can re-enter treated and/or surrounding areas (i.e. chambers, buildings and silos).the need of buffer zones for residents (subjected to revision considering the wind-speeds in the different Member States).Conditions of use shall include risk mitigation measures, where appropriate.
151	Beauveria bassiana strain 203Accession number at Centraal Bureau voor Schimmelcultures (Fungal Biodiversity Centre, Institute of the Royal Netherlands Academy of Arts and Sciences, Utrecht, Netherlands): CBS 121097	Not applicable	Max. level of beauvericin: 80 μg/kg in the formulated product.	19 April 2022	18 April 2032	Only uses on ornamental palm trees shall be authorised.For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Beauveria bassiana strain 203, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:a) the maximum level of the metabolite beauvericin in the plant protection product;b) the protection of operators and workers, taking into account that the species Beauveria basssiana, irrespective of the strain, is a potential human allergen by both skin and inhalatory exposure, and therefore ensuring that adequate personal protective equipment is included as a condition of use.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012^note.Conditions of use shall include risk mitigation measures, where appropriate.
152	Bifenazate149877-41-8736	isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate	980 g/kgToluene is of toxicological concern and must not exceed 0,7 g/kg in the technical material.	1 July 2022	30 June 2037	Only uses on non-edible crops in permanent greenhouses shall be authorised.For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on bifenazate, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment;the risk to bees and bumble bees released for pollination in permanent greenhouses.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit by 24 May 2024 to the Commission, the Member States and the Authority confirmatory information as regards points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605, in particular an updated assessment of the information submitted previously and, where relevant, further information to confirm the absence of endocrine activity.
153	Straight Chain Lepidopteran Pheromones (aldehydes)	Details are provided in the Review Report SANTE/10828/2021	Details are provided in the Review Report SANTE/10828/2021	1 September 2022	30 August 2037	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Straight Chain Lepidopteran Pheromones, and in particular Appendices I and II thereof, shall be taken into account.Member States shall pay particular attention to the efficacy of plant protection products containing either the individual single substances or blends thereof when evaluating applications for authorisation.Conditions of use shall include risk mitigation measures, where appropriate.
154	Straight Chain Lepidopteran Pheromones (alcohols)	Review Report SANTE SANTE/10828/2021	Review Report SANTE SANTE/10828/2021	1 September 2022	30 August 2037	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Straight Chain Lepidopteran Pheromones, and in particular Appendices I and II thereof, shall be taken into account.Member States shall pay particular attention to the efficacy of plant protection products containing either the individual single substances or blends thereof when evaluating applications for authorisation.Conditions of use shall include risk mitigation measures, where appropriate.
155	Pythium oligandrum strain M1Culture collection No ATCC 38472	Not applicable	No relevant impurities	1 March 2023	28 February 2038	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Pythium oligandrum strain M1, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the specification of the technical material as commercially manufactured,the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitisers and that physical effects on the respiratory system due to the remnants of culture medium and co-formulants in the Microbial Pest Control Product (MPCP) cannot be excluded.Conditions of use shall include risk mitigation measures, such as:adequate personal protective and respiratory protective equipment for operators using products containing Pythium oligandrum strain M1.
156	Pseudomonas chlororaphisstrain MA 342Culture collection: NCIMB, UK: NCIMB 40616	Not applicable	The amount of the secondary metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR) in the in the Microbial Pest Control Agent (MPCA) must not exceed the LOQ (2.0 μg/ml).	1 March 2023	28 February 2038	Only uses as fungicide for seed dressing in closed seed dressing machinery may be authorised.For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Pseudomonas chlororaphis strain MA 342, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the level of the metabolite 2,3-deepoxy-2,3-didehydro-rhizoxin (DDR) in the Microbial Pest Control Agent (MPCA), which must not exceed 2 μg/ml;the protection of operators and workers, taking into account that Pseudomonas chlororaphis strain MA 342 is to be considered, as any micro-organism, as a potential sensitiser, and paying special attention to exposure through inhalation.Strict maintenance of environmental conditions and quality control analysis during the manufacturing process, shall be assured by the producer, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:1. the phylogenetic taxonomic identification of the micro-organism in accordance with point 1.3 (identity, taxonomy and phylogeny) of Annex II, Part B of Commission Regulation (EU) 2022/1439;2. the secondary metabolite DDR in accordance with SANCO/2020/12258, in particular on its degradation rate;3. the potential for gene transfer of antibiotic resistance from Pseudomonas chlororaphis strain MA 342 to other micro-organisms in accordance with SANTE/2020/12260.The applicant shall submit the requested information referred to in points 1, 2 and 3 by 23 February 2025.
157	AbamectinCAS No 71751-41-2Avermectin B1aCAS No 65195-55-3Avermectin B1bCAS No 65195-56-4AbamectinCIPAC No 495	Avermectin B1a(10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranosideAvermectin B1b(10E,14E,16E)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl 2,6-dideoxy-4-O-(2,6-dideoxy-3-O-methyl-α-L-arabino-hexopyranosyl)-3-O-methyl-α-L-arabino-hexopyranoside	≥ 850 g/kg abamectin (sum of avermectin B1a and avermectin B1b), min. 800 g/kg avermectin B1a and max. 200 g/kg avermectin B1b	1 April 2023	31 March 2038	Only uses which allow controlled exchange of material and energy with the surroundings and prevent release of plant protection products into the environment may be authorised, in particular uses in permanent greenhouses.For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Abamectin, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, such as the the use of gloves;The effect of photolysis on the levels of pesticide residues in crops. Particular attention is required to ensure that available residue trials on crops reflect the most critical residue situation. Where appropriate, depending on the zone, seasonal restrictions for the timing of application shall be applied (cf. representative uses excluded application from November till February).
158	Bacillus amyloliquefaciens strain QST 713	n.a.	The nominal content of Bacillus amyloliquefaciens strain QST 713 in the technical product and formulation is Minimum: 1 × 10¹² CFU/kgMaximum: 3 × 10¹³ CFU/kgNo relevant impurities	1 July 2023	30 June 2038	When authorising plant protection products containing Bacillus amyloliquefaciens strain QST 713 for spray applications outdoors, in order to ensure the protection of non-target organisms, including bees, Member States shall:only authorise field applications in flowering crops or in presence of flowering weed in the field outside the daily foraging period of bees;implement risk mitigation measures which aim to reduce drift to off-field areas (e.g. considering the application of buffer zones and drift reduction nozzles).For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on Bacillus amyloliquefaciens strain QST 713, and in particular Appendices I and II thereof, shall be taken into account.In addition, Member States shall pay particular attention to:the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012the specification of the technical material as commercially manufactured used in plant protection products;the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitizers, ensuring that adequate personal protective equipment is included as a condition of use.
159	Bacillus thuringiensis subsp. aizawai strain ABTS-1857	n.a.	No relevant impurities	1 July 2023	30 June 2038	The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. aizawai strain ABTS-1857 and in particular Appendices I and II thereto, are taken into account.In this overall assessment the Member States shall pay particular attention to:the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use;the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012;the protection of wild pollinators (in particular honey bee larvae and bumble bees). Conditions of use shall include specific risk mitigation measures, where appropriate.Conditions of use shall include the following risk mitigation measures:a minimum time period of 2 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp. aizawai strain ABTS-1857 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. aizawai strain ABTS-1857 below 105 CFU/g at harvest.The applicant shall submit to the Commission, the Member States and the Authority additional information as regards:data in at least one representative edible crop (i.e. peppers and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. aizawai strain ABTS-1857 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 105 CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State. The applicant shall submit the requested information by 13 December 2025.
160	Bacillus thuringiensis subsp. aizawai GC-91	n.a.	No relevant impurities	1 July 2023	30 June 2038	The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. aizawai GC-91 and in particular Appendices I and II thereto, are taken into account.In this overall assessment the Member States shall pay particular attention to:the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use;the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012;the protection of wild pollinators (in particular honey bee larvae and bumble bees). Conditions of use shall include specific risk mitigation measures, where appropriate.Conditions of use shall include the following risk mitigation measures:a minimum time period of 2 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp aizawai GC-91 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. aizawai GC-91 below 105 CFU/g at harvest.The applicant shall submit to the Commission, the Member States and the Authority additional information as regards:data in at least one representative edible crop (i.e. pome fruits, grapes and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. aizawai GC-91 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 105 CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State. The applicant shall submit the requested information by 13 December 2025.
161	Bacillus thuringiensis subsp. israelensis strain AM65-52Culture collection No ATCC 1276	Not applicable	No relevant impurities	1 July 2023	30 June 2038	The implementation of the uniform principles, provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the renewal report on Bacillus thuringiensis subsp. israelensis strain AM65-52, and in particular Appendices I and II thereof, are taken into account.In this overall assessment, the Member States shall pay particular attention to:the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitizers;the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012.the protection of wild pollinators and of aquatic organisms (e.g. aquatic invertebrates from Diptera taxon in particular) in case of uses in open field. Conditions of use shall include specific risk mitigation measures, where appropriate.Conditions of use shall include risk mitigation measures, such as:adequate personal protective equipment for operators using products containing Bacillus thuringiensis subsp. israelensis strain AM65-52;In case of authorisation of uses on edible crops, a minimum time period of 3 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp. israelensis AM65-52 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. israelensis AM65-52 below 105 CFU/g at harvest.
162	Bacillus thuringiensis subsp. kurstaki ABTS-351	n.a.	No relevant impurities	1 July 2023	30 June 2038	The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki ABTS-351 and in particular Appendices I and II thereto, are taken into account.In this overall assessment, the Member States shall pay particular attention to:the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use;the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012.Conditions of use shall include the following risk mitigation measures:a minimum time period of 2 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp. kurstaki ABTS-351 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. kurstaki ABTS-351 below 105 CFU/g as recommended by EFSA.The applicant shall submit, to the Commission, the Member States and the Authority, additional information as regards:Data in at least one representative edible crop (i.e. on cabbage and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki ABTS-351 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 105 CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State by 13 December 2025.
163	Bacillus thuringiensis subsp. kurstaki EG2348	n.a.	No relevant impurities	1 July 2023	30 June 2038	The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki EG2348 and in particular Appendices I and II thereto, are taken into account.In this overall assessment, the Member States shall pay particular attention to:the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use;the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012.Conditions of use shall include the following risk mitigation measures:a minimum time period of 2 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp kurstaki EG2348 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. kurstaki EG2348 below 105 CFU/g as recommended by EFSA.The applicant shall submit, to the Commission, the Member States and the Authority, additional information as regards:data in at least one representative edible crop (i.e. on pome fruits and solanaceous vegetables during the fruiting period) regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki EG2348 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 105 CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State by 13 December 2025.
164	Bacillus thuringiensis subsp. kurstaki PB 54	n.a.	No relevant impurities	1 July 2023	30 June 2038	The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki PB 54 and in particular Appendices I and II thereto, are taken into account.In this overall assessment, the Member States shall pay particular attention to:the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use;the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012.Conditions of use shall include the following risk mitigation measures:a minimum time period of 2 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp. kurstaki PB 54 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. kurstaki PB 54 below 105 CFU/g as recommended by EFSA.The applicant shall submit to the Commission, the Member States and the Authority additional information as regards:data in at least one representative edible crop (i.e. on stone fruits and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki PB 54 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 105 CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State by 14 December 2025.
165	Bacillus thuringiensis subsp. kurstaki SA-11	n.a.	No relevant impurities	1 July 2023	30 June 2038	The implementation of the uniform principles, provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki SA-11 and in particular Appendices I and II thereto, are taken into account.In this overall assessment, the Member States shall pay particular attention to:the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use;the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012.Conditions of use shall include the following risk mitigation measures:a minimum time period of 2 days shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp kurstaki SA-11 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. kurstaki SA-11 below 105 CFU/g as recommended by EFSA.The applicant shall submit, to the Commission, the Member States and the Authority, additional information as regards:data in at least one representative edible crop (i.e. on pome fruits and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki SA-11 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 105 CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State. by 13 December 2025.
166	Bacillus thuringiensis subsp. kurstaki SA-12	n.a.	No relevant impurities	1 July 2023	30 June 2038	The implementation of the uniform principles, as provided for in Article 29(6) of Regulation (EC) No 1107/2009, requires that the conclusions of the review report on Bacillus thuringiensis subsp. kurstaki SA-12 and in particular Appendices I and II thereto, are taken into account.In this overall assessment, the Member States shall pay particular attention to:the protection of operators and workers, taking into account that micro-organisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use;the assurance by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure the fulfilment of the limits on microbiological contamination as referred to in the Working Document SANCO/12116/2012.Conditions of use shall include the following risk mitigation measures:A minimum time period of 1 day shall be kept between the application of plant protection products containing Bacillus thuringiensis subsp. kurstaki SA-12 and the harvest of edible crops used for fresh consumption, unless available measured or estimated residues data show levels of Bacillus thuringiensis subsp. kurstaki SA-12 below 105 CFU/g as recommended by EFSA.The applicant shall submit, to the Commission, the Member States and the Authority, additional information as regards:data in at least one representative edible crop (i.e. on pome fruits and tomatoes) regarding the density decline of viable spores of Bacillus thuringiensis subsp. kurstaki SA-12 on edible plant parts from the time of application of a plant protection product containing this active substance until the time of harvest or until levels found are below 105 CFU/g, including storage stability data of the micro-organisms between the sampling and the spore counting analysis. The relevant methods and protocols to be employed shall be agreed between the applicant and the Rapporteur Member State by 13 December 2025.
167	Aluminium ammonium sulfate (dodecahydrate)CAS No: 7784-26-1CIPAC No: 840	Aluminium ammonium sulfate	975 g/kgAnhydrous - Not less than 510 g/kgNo relevant impurities	1.2.2024	31.1.2039	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Aluminium ammonium sulfate, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers where relevant, ensuring that conditions of use include the application of adequate personal protective equipment;the protection of aquatic organisms when the substance is applied in regions with acidic or basic soil conditions;the protection of bees from spray applications during the flowering period of adjacent fields or when flowering weeds are present in the treated field;the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions (i.e. situations when soil pH is lower than 5,5, e.g. grassland in upland areas, areas of coniferous forestry and areas of ericaceous ornamental plant growing);the authorisation, for use on row and combinable crops, as a barrier treatment only on field edges.Conditions of use shall include risk mitigation measures where relevant.
168	EthephonCAS No: 16672-87-0CIPAC No: 373	2-chloroethylphosphonic acid	≥ 692 g/kg (TK)≥ 910 g/kg (TC, theoretical)The following impurities are of toxicological concern and shall not exceed the following levels in the technical material:TK:1,2-dichloroethane < 0,3 g/kg2-chloroethanol < 0,3 g/kgTC (theoretical):1,2-dichloroethane < 0,5 g/kg2-chloroethanol < 0,3 g/kg	1 February 2024	31 January 2039	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on ethephon, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment;the protection of bystanders and residents, ensuring that conditions of use include the use of drift reduction equipment during application.Conditions of use shall include risk mitigation measures, where appropriate.
169	Trinexapac-ethylCAS No 95266-40-3CIPAC No 732.202	ethyl (1RS,4EZ)-4-cyclopropyl(hydroxy)methylene-3,5-dioxocyclohexanecarboxylate	≥ 950 g/kgThe following impurities shall not exceed the following levels in the technical material:toluene: 3 g/kgethyl (1RS)-3-hydroxy-5-oxocyclohex-3-ene-1-carboxylate (CGA158377): 6 g/kg	1 May 2024	30 April 2039	For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on trinexapac-ethyl, and in particular Appendices I and II thereof, shall be taken into account.In their overall assessment Member States shall pay particular attention to:the specification of technical material used in plant protection products, in particular when carrying out assessments of equivalence in accordance with Article 38 of Regulation (EC) No 1107/2009;the assessment of consumer intake from the diet taking into account the residues of the metabolites of trinexapac-ethyl and the impact of processing;the levels of residues of the metabolites of trinexapac-ethyl, when straw is used as animal feeding stuff.Conditions of use shall include restrictions for feeding of straw to animals and risk mitigation measures, where appropriate.The applicant shall submit to the Commission, Member States and the Authority confirmatory information as regards the effect of water treatment processes on the nature of residues of trinexapac-ethyl and its metabolites present in surface water, when surface water is abstracted for drinking water, by 1 April 2026.
170	CaptanCAS No 133-06-2CIPAC No 40	N-[(trichloromethyl)thio]cyclohex-4-ene–1,2-dicarboximide	≥ 930 g/kgperchloromethylmercaptan: ≤ 5 g/kgfolpet: ≤ 10 g/kgcarbon tetrachloride: ≤ 0,1 g/kg	1 November 2024	31 October 2039	For outdoor uses the following conditions shall apply:only uses outside flowering of the crop and when no flowering weeds are present in the rows of the treated crops may be authorised,Member States shall require that applications in orchards (e.g. apples, cherries) are only done with application equipment that increases the precision and accuracy of the application (e.g. emission shields, shielded sprayers, hooded sprayers, tunnel sprayers, sensor-controlled sprayers), and, while maintaining the application rate on the target surfaces, achieves an average reduction of at least 61 % of the applied plant protection product (per hectare) and a minimum of 20 % reduction of plant protection product loss to the ground compared to applications via conventional application equipment and practice.For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on captan, and in particular Appendices I and II thereto, shall be taken into account. In addition, risk mitigations such as no-spray buffer zones from field margins, shall be required, when appropriate, by the Member States on the basis of their risk assessment to protect bees and aquatic organisms.In this overall assessment Member States shall pay particular attention to:the compliance with the technical specification of the active substance contained in the plant protection product for which applications for authorisation are submitted,the protection of operators and workers ensuring that conditions of use include the application of adequate personal protective equipment taking into account the high skin sensitising potential of the active substance,the protection of bystanders and residents ensuring that conditions of use include adequate risk mitigation measures taking into account the high skin sensitising potential of the active substance.In addition, Member States may set monitoring requirements when granting authorisations, in order to supplement the monitoring under Directives 2000/60/EC^note and 2009/128/EC^note of the European Parliament and of the Council.Within two years from 24 September 2024, the applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:(1) the effect of water treatment processes on the nature of residues of captan’s metabolites THPI and THPAM present in ground water, when it is abstracted for drinking water;(2) the relevance of metabolites THPI and THPAM that may occur in groundwater, taking into account the proposal of classification of captan as toxic to reproduction Category 2 and as STOT-RE Category 1 in the Opinion of the Risk Assessment Committee of the European Chemicals Agency of 14 September 2023;(3) the storage stability of captan in high acid content matrices, in compliance with the relevant OECD Test Guideline; and Furthermore, within 18 months from 24 September 2024, the applicant shall submit to the Commission, the Member States and the Authority:(4) information and exposure data demonstrating that the pesticide application equipment used on orchards increases the precision and accuracy of the application and achieves a reduction of exposure of at least 61 % of the applied plant protection product (per hectare) and a minimum of 20 % reduction of plant protection product loss to the ground compared to applications via conventional equipment and practices.
171	MetrafenoneCAS No: 220899-03-6CIPAC No: 752	3′-bromo-2,3,4,6′-tetramethoxy-2′,6-dimethylbenzophenone	≥ 980 g/kgThe impurity dimethyl sulphate shall not exceed 0,01 g/kg in the technical material.	1 November 2024	31 October 2039	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on metrafenone, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers;the consumer exposure assessment with regards to residues that may be present in food.Conditions of use shall include risk mitigation measures, where appropriate.1) An updated assessment for point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 to confirm the absence of endocrine activity concerning the T-modality of non-target organisms other than mammals, including where relevant, further information.2) An updated assessment of the genotoxicity of the metabolites CL 1500834 and CL 3000402.The applicant shall submit the information related to point 1 by 29 March 2026 and the information related to point 2 by 29 December 2024.
172	FolpetCAS No: 133-07-3CIPAC No: 75	N-[(trichloromethyl)thio]phthalimide	≥ 940 g/kgThe following impurities shall not exceed the following levels in the technical material:(trichloro(chlorosulfanyl) methane) (PCMM): 2 g/kgcarbon tetrachloride: 2 g/kgcaptan: 3 g/kgcarbon disulphide: 2,5 g/kg	1 November 2024	31 October 2039	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on folpet, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of aquatic organisms, ensuring a minimum of 95 % spray drift reduction next to water bodies such as that provided by a 20 m no spray buffer zone unless the outcome of the risk assessment undertaken for the specific plant protection product use indicates that such risk mitigation measures are not needed or can be lowered because there are no unacceptable risks caused by spray drift;the protection of operators (use of PPE for operators during mixing, loading and application) and workers (use of workwear and protective gloves for re-entry activities); andthe protection of bystanders and residents, ensuring that conditions of use include the adequate risk mitigation measures, such as drift reduction equipment, with the aim of minimising exposure.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information to determine the levels of phthalic acid deriving from the use of folpet taking into account the background levels of phthalic acid in wheat and barley during residue field trials for the uses listed in Appendix II of the renewal report only.The applicant shall submit to the Commission, the Member States and the Authority this information by 25 March 2025.
173	Mepiquat chlorideCAS No: 24307-26-4CIPAC No: 440.302	1,1-dimethylpiperidinium chloride	≥ 990 g/kg (theoretical dry technical material, TC)615-665 g/L (technical concentrate, TK)The impurity N-methylpiperidine shall not exceed 3 g/kg (on theoretical dry weight basis) or 2 g/L (in the technical concentrate, TK).	1 March 2025	29 February 2040	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on mepiquat chloride, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the specification of the technical material as commercially manufactured;the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment.Conditions of use shall include risk mitigation measures, where appropriate.
174	Pythium oligandrum B301	Not applicable	No relevant impurities	11 February 2025	10 February 2035	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on Pythium oligandrum B301, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators and workers, taking into account that microorganisms are per se considered as potential sensitisers, ensuring that adequate personal protective equipment is included as a condition of use,the guarantee by the producer of strict maintenance of environmental conditions and quality control analysis during the manufacturing process, in order to ensure adherence to the limits on microbiological contamination as set in the OECD Issue Paper on Microbial Contaminants Limits for Microbial Pest Control Products No 65.Conditions of use shall include risk mitigation measures, where appropriate.
175	LenacilCAS No: 2164-08-01CIPAC No: 163	3-cyclohexyl-6,7-dihydro-1H-cyclopenta[d]pyrimidine-2,4(3H,5H)-dioneor3-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4(3H)-dione	975 g/kg	1 July 2025	30 June 2040	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on lenacil, and in particular Appendices I and II thereto, shall be taken into account.Conditions of use shall include risk mitigation measures, where appropriate.In this overall assessment Member States shall pay particular attention to the possible need for additional rotational crop field trials and a livestock exposure assessment until the required confirmatory information has been assessed by the rapporteur Member State and evaluated by the Authority.By 25 March 2027, the applicant shall submit to the Commission, the Member States and the Authority confirmatory information on rotational crops field trials, including analysis for known and possible new metabolites. If new metabolites are found, the applicant is requested to perform toxicological studies assessing these metabolites. The applicant is requested to perform an appropriate livestock exposure assessment if necessary.
176	MilbemectinMilbemectin is a mixture of M.A₃ and M.A₄CAS No:M.A₃: 51596-10-2M.A₄: 51596-11-3CIPAC No: 660	M.A₃: (10E,14E,16E)- (1R,4S,5′S,6R,6′R,8R,13R, 20R,21R,24S)- 21,24-dihydroxy-5′,6′,11,13,22-pentamethyl-(3,7,19-trioxatetracyclo[15.6.1.1^4,8.0^20,24] pentacosa-10,14,16, 22-tetraene)-6-spiro-2′- (tetrahydropyran)-2-one;M.A₄: (10E,14E,16E)- (1R,4S,5′S,6R,6′R,8R,13R, 20R,21R,24S)-6′-ethyl-21,24- dihydroxy-5′,11,13,22-tetramethyl-(3,7,19-trioxatetracyclo[15.6.1.1^4,8.0^20,24] pentacosa-10,14,16,22-tetraene)-6- spiro-2′-(tetrahydropyran)-2-one	≥ 950 g/kg	16 November 2025	15 November 2040	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on milbemectin, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the specification of the technical material as commercially manufactured;the protection of operators and workers ensuring that conditions of use include the application of adequate personal protective equipment;the protection of bees and pollinators that may be exposed to the active substance by visiting the flowers present in the crop at the time of application;the protection of aquatic organisms.Conditions of use shall include risk mitigation measures, in particular to reduce drift to terrestrial and aquatic areas outside the treated field, where appropriate.The applicant shall submit confirmatory information as follows:1. to confirm that the bone marrow was exposed in the available in vivo micronucleus test or to confirm the absence of the aneugenic potential of milbemectin;2. an in vitro comparative metabolism study with milbemectin (at least in the pivotal species used to characterise milbemectin’s toxicity and in comparison with human metabolism);3. an in vitro phototoxicity study with milbemectin, testing the range of wavelengths (between 290 and 700 nm) where the absorption coefficient is > 10 L x mol-1 x cm-1;4. an updated risk assessment for the aquatic sediment organisms in accordance with the EFSA Guidance document on tiered risk assessment for plant protection products for aquatic organisms in edge of field surface waters. To allow for proper comparison of the sensitivity with other species, this confirmatory information should include a spiked-sediment test (OECD TG 218) and spiked-water test (OECD TG 219) with Chironomidae exposed to milbemectin, where milbemycin A3/milbemycin A4 is present in the same ratio than in other ecotoxicology studies.The applicant shall submit to the Commission, the Member States and the Authority the information referred to the points above by 5 November 2027.
177	SpinosadCAS No:Spinosad: 168316-95-8Spinosyn A: 131929-60-7Spinosyn D: 131929-63-0CIPAC No: 636	Spinosyn A: (50–95 %)(2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-β-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-14-methyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dioneSpinosyn D: (50–5 %)(2S,3aR,5aS,5bS,9S,13S,14R,16aS,16bS)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-mannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy-β-D-erythropyranosyloxy)-9-ethyl-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-4,14-dimethyl-1H-as-indaceno[3,2-d]oxacyclododecine-7,15-dione	≥ 850 g/kgwith 50–95 % of spinosyn A and 5–50 % of spinosyn D	1 April 2026	1 April 2041	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on spinosad of 21 January 2026, and in particular, Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the assessment of the consumer intake, taking into account the residues of the metabolites of spinosad and considering the impact of storage and processing;the protection of operators, in particular for hand-held applications in low crops;the protection of wild mammals, aquatic organisms, bees and non-target arthropods.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) an in vitro interspecies comparative metabolism study;(2) an overall assessment of DNT (developmental neurotoxicity) including the submission of data from an in vitro DNT test battery;(3) the toxicity and magnitude of residues in plant and animal matrices of spinosyn B and K, PsA and MET A-Li-4(5b) to confirm the residue definitions for risk assessment;(4) the effect of water treatment processes on the nature of residues present in drinking water;(5) chronic effects on honeybees (adults and larvae).The applicant shall submit the information referred to in point 1, 3, and 4 to the Commission, the Member States and the Authority by 11 March 2028.The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 2 within two years after adoption of a guidance document on assessing DNT. The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 5 within two years after the adoption of a guidance document with a revised risk assessment methodology for honeybees.
178	BixlozoneCAS No: 81777-95-9CIPAC No: Not allocated	2-(2,4-dichlorobenzyl)-4,4-dimethylisoxazolidin-3-one	≥ 960 g/kgThe impurity TBAB shall not exceed 2 g/kg in the technical material.	21 April 2026	21 April 2036	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on bixlozone and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the co-formulants present in bixlozone-containing plant protection products, taking into account in particular the criteria for identification of unacceptable co-formulants as set out in Implementing Regulation (EU) 2023/574,the consumer risk assessment, in particular for residues present in succeeding crops, including the setting of appropriate plant-back intervals,the protection of aquatic organisms and non-target terrestrial plants.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:1. the technical specification of the active substance as manufactured (based on commercial scale production), the relevance of one of the impurities and the compliance of the toxicity batches with the confirmed technical specification;2. the natural occurrence of 2,2-dimethyl-3-OH-propionic acid and dimethylmalonic acid;3. the genotoxic and general toxicity potential of dimethylmalonic acid (free and conjugated), 2,2-dimethyl-3-OH-propionic acid (free and conjugated), F9600-dimethyl-malonamide, F9600-hydroxy-isobutyramide and F9600-3-OH-propanamide;4. the relevance of the livestock metabolites dimethylmalonic acid, F9600-dimethyl-malonamide and F9600-3-OH-propanamide;5. the effect of water treatment processes on the nature of residues present in surface water and groundwater, when surface water or groundwater is abstracted for drinking water.The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1 to 5 of the fourth subparagraph by 21 April 2028.
179	PyrimethanilCAS No: 53112-28-0CIPAC No: 714	N-(4,6-dimethylpyrimidin-2-yl) aniline	≥ 975 g/kgThe following impurities shall not exceed the following levels in the technical material:cyanamide: 0,5 g/kg;aniline: 4 g/kg;acetylacetone: 0,1 g/kg.	1 May 2026	30 April 2041	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on pyrimethanil, and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment;the protection of bystanders and residents, ensuring that drift reduction measures are applied, where necessary;the protection of aquatic organisms, bees and other pollinators.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information as regards:(1) the toxicity of the metabolite M605F004, including its conjugates, and the metabolite M605F007, to confirm the relevant residue definitions for risk assessment;(2) the effect of water treatment processes on the residues of pyrimethanil or its metabolites present in water abstracted for the production of drinking water, in accordance with the EFSA and ECHA Guidance document on the impact of water treatment processes on residues of active substances or their metabolites in water abstracted for the production of drinking water;(3) the degradation of pyrimethanil in soil, including where relevant the identification and characterisation of metabolites. If the information indicates the relevance of the metabolite U2, soil, surface water, sediment and groundwater exposure and risk assessment for the metabolite U2 shall be provided.The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1.2 and 3 by 11 March 2028.
180	Paraffin oil (Not ISO)Paraffin, light liquid ‘‘Paraffinum Perliquidum’’ (European Pharmacopoeia, EurPharm)CAS No: 8042-47-5CIPAC No: 898	White mineral oil (petroleum) (Not IUPAC)	1000 g/kgThe impurity Polycyclic Aromatic Hydrocarbons (PAHs) shall not exceed 0,3 mg/kg in the technical material in accordance with the European Pharmacopoeia.	1 July 2026	30 June 2041	For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on paraffin oil (CAS 8042-47-5), and in particular Appendices I and II thereto, shall be taken into account.In this overall assessment Member States shall pay particular attention to:the consumer risk assessment, in particular to ensure compliance with maximum levels that are set in Union law for total mineral oil aromatic hydrocarbon (MOAH);the protection of aquatic organisms, non-target arthropods in off field area and bees.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall submit confirmatory information to:(1) demonstrate the compliance of technical grade paraffin oil with the maximum level of PAH (PAH4- benzo(a)pyrene, benz(a)anthracene, benzo(b) fluoranthene and chrysene and PAH8) in the technical specification (0,3 mg/kg) with validated analytical methods for the determination of those PAHs in the technical paraffin oil and the formulations for the representative uses as proposed by the applicant;(2) complete the consumer risk assessment, where exposure to PAH residues shall be estimated using an approach based on application rate and yield rate for the representative uses as proposed by the applicant. This risk assessment shall be carried out based on that estimated exposure.The applicant shall submit to the Commission, the Member States and the Authority the information referred to in points 1 and 2 by 12 May 2027.

Commission Implementing Regulation (EU) No 540/2011

PART B — Active substances approved under Regulation (EC) No 1107/2009

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PART B — Active substances approved under Regulation (EC) No 1107/2009

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