Contents
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) No 649/2012 of the European Parliament and of the Council of 4 July 2012 concerning the export and import of hazardous chemicalsnote, and in particular Article 23(4), point (a), thereof,Whereas:
(1)Regulation (EU) No 649/2012 implements the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Tradenote (‘the Rotterdam Convention’).
(2)By Implementing Regulations (EU) 2021/1379note and (EU) 2022/94note, the Commission decided not to renew the approval of the substances famoxadone and phosmet, respectively, as active substances under Regulation (EC) No 1107/2009 of the European Parliament and of the Councilnote. The effect of that decision is that famoxadone and phosmet are banned from all use in the category ‘pesticides’, due to the fact that they have not been approved for any other use in that category. Therefore, famoxadone and phosmet should be added to the lists of chemicals set out in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.
(3)By Implementing Regulation (EU) 2021/2081note, the Commission decided not to renew the approval of the substance indoxacarb as an active substance under Regulation (EC) No 1107/2009. That decision amounts to a severe restriction of the use of that substance at the level of the category ‘pesticides’, considering that indoxacarb is only approved for use in biocidal products under Regulation (EU) No 528/2012 of the European Parliament and of the Councilnote for product-type 18 in the subcategory ‘other pesticide including biocides’. Therefore, indoxacarb should be added to the lists of chemicals set out in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.
(4)By Implementing Regulation (EU) 2021/795note the Commission decided to withdraw the approval of the substance alpha-cypermethrin as an active substance under Regulation (EC) No 1107/2009. The effect of that decision is that alpha-cypermethrin is banned from use in the subcategory ‘pesticide in the group of plant protection products’. In addition, the harmonised classification of alpha-cypermethrin under Regulation (EC) No 1272/2008 of the European Parliament and of the Councilnote is sufficient evidence that the substance raises concerns for human health or the environment. Therefore, alpha-cypermethrin should be added to the list of chemicals set out in Part 1 of Annex I to Regulation (EU) No 649/2012.
(5)The active substance bromadiolone has been withdrawn by industry from the approval process under Regulation (EC) No 1107/2009. The effect of that withdrawal is that bromadiolone is banned from use in the subcategory ‘pesticide in the group of plant protection products’. In addition, the harmonised classification of bromadiolone under Regulation (EC) No 1272/2008 is sufficient evidence that the substance raises concerns for human health or the environment. Therefore, bromadiolone should be added to the list of chemicals set out in Part 1 of Annex I to Regulation (EU) No 649/2012.
(6)The active substance metam-sodium has been withdrawn by industry from the approval process under Regulation (EU) No 528/2012. The effect of that withdrawal is that metam-sodium is banned from all use in the subcategory ‘other pesticide including biocides’. In addition, the harmonised classification of that substance under Regulation (EC) No 1272/2008 is sufficient evidence that the substance raises concerns for human health or the environment. Therefore, metam-sodium should be added to the list of chemicals set out in Part 1 of Annex I to Regulation (EU) No 649/2012.
(7)By Implementing Regulation (EU) 2022/782note the Commission decided to withdraw the approval of the substance isopyrazam as an active substance under Regulation (EC) No 1107/2009. The effect of that decision is that isopyrazam is banned from all use in the category ‘pesticides’, due to the fact that it has not been approved for any other use in that category. Therefore, isopyrazam should be added to the lists of chemicals set out in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.
(8)The active substance diuron has been withdrawn by industry from the approval process under Regulation (EC) No 1107/2009. The effect of that withdrawal is that the use of diuron is severely restricted at the level of the category ‘pesticides’, considering that diuron is only allowed to be used in biocidal products under Regulation (EU) No 528/2012 for product-types 7 and 10 in the subcategory ‘other pesticide including biocides’. In addition, the harmonised classification of diuron under Regulation (EC) No 1272/2008 is sufficient evidence that the substance raises concerns for human health or the environment. Therefore, diuron should be added to the lists of chemicals set out in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.
(9)The active substances azimsulfuron, carbetamide, carboxin, cyproconazole, ethametsulfuron-methyl, etridiazole, fenbuconazole, fluquinconazole, lufenuron, metosulam, myclobutanil, pencycuron, prochloraz, profoxydim, spirodiclofen and triflumizole have been withdrawn by industry from the approval process under Regulation (EC) No 1107/2009. The effect of that withdrawal is that those substances are banned from all use in the category ‘pesticides’, due to the fact that they have not been approved for any other use in that category. In addition, the harmonised classification of those substances under Regulation (EC) No 1272/2008 is sufficient evidence that the substances raise concerns for human health or the environment. Therefore, those substances should be added to the lists of chemicals set out in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.
(10)By Implementing Decisions (EU) 2018/622note, (EU) 2020/1765note and (EU) 2021/98note, the Commission decided not to approve the substances chlorophene and esbiothrin as active substances under Regulation (EU) No 528/2012. The effect of that decision is that chlorophene and esbiothrin are banned from all use in the category ‘pesticides’, due to the fact that the substances have not been approved for any other use in that category. Therefore, chlorophene and esbiothrin should be added to the lists of chemicals set out in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.
(11)The active substance fenoxycarb has been withdrawn by industry from the approval processes under Regulation (EC) No 1107/2009 and under Regulation (EU) No 528/2012. The effect of those withdrawals is that fenoxycarb is banned from use in the category ‘pesticides’. In addition, the harmonised classification of fenoxycarb under Regulation (EC) No 1272/2008 is sufficient evidence that the substance raises concerns for human health or the environment. Therefore, fenoxycarb should be added to the lists of chemicals set out in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.
(12)By Commission Delegated Regulation (EU) 2018/172note, the substance triflumuron has been added to the list of chemicals set out in Part 1 of Annex I to Regulation (EU) No 649/2012, based on a ban in the subcategory ‘other pesticide including biocides’. In addition, the active substance triflumuron has been withdrawn by industry from the approval process under Regulation (EC) No 1107/2009 and the conclusions of the risk assessment under Regulation (EU) No 528/2012 constitute sufficient evidence that the substance raises concerns for human health or the environment, which amounts to a ban in the subcategory ‘pesticide in the group of plant protection products’. Consequently, triflumuron is banned from all use in the category ‘pesticides’ and should be added to the list of chemicals set out in Part 2 of Annex I to Regulation (EU) No 649/2012.
(13)By Commission Delegated Regulation (EU) No 1078/2014note, the substance cyfluthrin has been added to the list of chemicals set out in Part 1 of Annex I to Regulation (EU) No 649/2012, based on a ban in the subcategory ‘pesticide in the group of plant protection products’. That ban amounts to a severe restriction of the use of that substance at the level of the category ‘pesticides’, considering that cyfluthrin is only approved for use in biocidal products under Regulation (EU) No 528/2012 for product-type 18 in the subcategory ‘other pesticide including biocides’. Therefore, cyfluthrin should be added to the list of chemicals set out in Part 2 of Annex I to Regulation (EU) No 649/2012.
(14)The substances chlorfenvinphos and terbufos are not approved as active substances under Regulation (EC) No 1107/2009 and those substances are not approved as active substances under Regulation (EU) No 528/2012. Consequently, chlorfenvinphos and terbufos are banned from all use in the category ‘pesticides’ and should be listed in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012. Since chlorfenvinphos and terbufos are already listed in Part 1 they should be added to the list of chemicals set out in Part 2 of Annex I to Regulation (EU) No 649/2012.
(15)The substances 1-bromopropane, diisopentyl phthalate, 1,2-benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7 rich, 1,2-benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters, 1,2-benzenedicarboxylic acid, dipentylester, branched and linear, bis(2-methoxyethyl) phthalate, dipentyl phthalate and n-pentyl-isopentyl phthalate are listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Councilnote since they have been previously identified as substances of very high concern. Consequently, those substances are subject to authorisation in accordance with Title VII of Regulation (EC) No 1907/2006. Since no authorisations have been granted, those substances are severely restricted for industrial use. Therefore, those substances should be added to the lists of chemicals set out in Parts 1 and 2 of Annex I to Regulation (EU) No 649/2012.
(16)At its tenth meeting held from 6 to 17 June 2022, the Conference of the Parties to the Rotterdam Convention decided to include decabromodiphenyl ether and perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds in Annex III to that Convention, with the effect that those chemicals became subject to the prior informed consent procedure under that Convention. Consequently, those chemicals should be added to the list of chemicals set out in Part 3 of Annex I to Regulation (EU) No 649/2012. Since decabromodiphenyl ether and perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds are already listed in Part 2 of Annex I to that Regulation, those chemicals should be removed from the list of chemicals set out in Part 2 of Annex I to Regulation (EU) No 649/2012.
(17)The entries for bromoxynil, epoxiconazole and nonylphenol ethoxylates included in the lists of chemicals set out in Parts 1 and 2 of Annex I should be amended by clarifying the scope or adding additional numerical identifiers in order to facilitate implementation of Regulation (EU) No 649/2012.
(18)Regulation (EU) No 649/2012 should therefore be amended accordingly.
(19)It is appropriate to provide for a reasonable period of time for interested parties to take the measures necessary to comply with this Regulation and for Member States to take the measures necessary for its implementation,
HAS ADOPTED THIS REGULATION:
Article 1#
Annex I to Regulation (EU) No 649/2012 is amended in accordance with the Annex to this Regulation.
Article 2#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.It shall apply from 1 November 2023.
(1)in Part 1, in the table, the following entries are added:Chemical | CAS No | EC No | CN code(***) | Subcategory (*) | Use limitation (**) | Countries for which no notification is required1-bromopropane (n-propyl bromide) (+) | 106-94-5 | 203-445-0 | ex29036919 | i(1)-i(2) | sr-b |1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich (+) | 71888-89-6 | 276-158-1 | ex29173400 | i(1)-i(2) | sr-b |1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters (+) | 68515-42-4 | 271-084-6 | ex29173400 | i(1)-i(2) | sr-b |1,2-Benzenedicarboxylic acid, dipentyl ester, branched and linear (+) | 84777-06-0 | 284-032-2 | ex29173400 | i(1)-i(2) | sr-b |Alpha-cypermethrin | 67375-30-8 | | ex29269070 | p(1) | b |Azimsulfuron (+) | 120162-55-2 | | ex29359090 | p(1) | b |Bis(2-methoxyethyl) phthalate (+) | 117-82-8 | 204-212-6 | ex29173400 | i(1)-i(2) | sr-b |Bromadiolone | 28772-56-7 | 249-205-9 | ex29322090 | p(1) | b |Carbetamide (+) | 16118-49-3 | 240-286-6 | ex29242970 | p(1) | b |Carboxin (+) | 5234-68-4 | 226-031-1 | ex29349990 | p(1) | b |Chlorophene (+) | 120-32-1 | 204-385-8 | ex29081900 | p(2) | b |Cyproconazole (+) | 94361-06-5 | | ex29339980 | p(1) | b |Diisopentyl phthalate (+) | 605-50-5 | 210-088-4 | ex29173400 | i(1)-i(2) | sr-b |Dipentyl phthalate (+) | 131-18-0 | 205-017-9 | ex29173400 | i(1)-i(2) | sr-b |Diuron (+) | 330-54-1 | 206-354-4 | ex29242100 | p(1) | b |Esbiothrin (+) | 260359-57-7 | | ex29162000 | p(2) | b |Ethametsulfuron-methyl (+) | 97780-06-8 | | ex29359090 | p(1) | b |Etridiazole (+) | 2593-15-9 | 219-991-8 | ex29349990 | p(1) | b |Famoxadone (+) | 131807-57-3 | | ex29349990 | p(1) | b |Fenbuconazole (+) | 114369-43-6 | 406-140-2 | ex29339980 | p(1) | b |Fenoxycarb (+) | 72490-01-8 | 276-696-7 | ex29242970 | p(1)-p(2) | b-b |Fluquinconazole (+) | 136426-54-5 | 411-960-9 | ex29335995 | p(1) | b |Indoxacarb (+) | 173584-44-6144171-61-9 | | ex29349990 | p(1) | b |Isopyrazam (+) | 881685-58-1 | | ex29331990 | p(1) | b |Lufenuron (+) | 103055-07-8 | 410-690-9 | ex29242100 | p(1) | b |Metam-sodium | 137-42-8 | 205-293-0 | ex29302000 | p(2) | b |Metosulam (+) | 139528-85-1 | 410-240-1 | ex29359030 | p(1) | b |Myclobutanil (+) | 88671-89-0 | 410-400-0 | ex29339980 | p(1) | b |n-pentyl-isopentyl phthalate (+) | 776297-69-9 | | ex29173400 | i(1)-i(2) | sr-b |Pencycuron (+) | 66063-05-6 | 266-096-3 | ex29242100 | p(1) | b |Phosmet (+) | 732-11-6 | 211-987-4 | ex29309098 | p(1) | b |Prochloraz (+) | 67747-09-5 | 266-994-5 | ex29332990 | p(1) | b |Profoxydim (+) | 139001-49-3 | | ex29349990 | p(1) | b |Spirodiclofen (+) | 148477-71-8 | | ex29322090 | p(1) | b |Triflumizole (+) | 68694-11-1 | | ex29332990 | p(1) | b |
(2)in Part 1, in the table, the entries for bis(pentabromophenyl) ether, bromoxynil, chlorfenvinphos, cyfluthrin, epoxiconazole, nonylphenol ethoxylates, perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds, terbufos and triflumuron are replaced by the following entries:Chemical | CAS No | EC No | CN code(***) | Subcategory (*) | Use limitation (**) | Countries for which no notification is requiredBis(pentabromophenyl) ether (decabromodiphenyl ether) (#) | 1163-19-5 | 214-604-9 | ex29093038 | i(1)-i(2) | sr-b |Bromoxynil and its butyryl, heptanoyl and octanoyl esters (+) | 1689-84-53861-41-456634-95-81689-99-2 | 216-882-7223-374-9260-300-4216-885-3 | ex29269070 | p(1) | b |Chlorfenvinphos (+) | 470-90-6 | 207-432-0 | ex29199000 | p(1)-p(2) | b-b |Cyfluthrin (+) | 68359-37-5 | 269-855-7 | ex29269070 | p(1) | b |Epoxiconazole (+) | 135319-73-2133855-98-8 | 406-850-2 | ex29349990 | p(1) | b |Nonylphenol ethoxylates (C2H4O)nC15H24O (+) | 9016-45-926027-38-368412-54-437205-87-1127087-87-0and others | 500-024-6500-045-0500-209-1932-337-2500-315-8and others | ex34024200ex39072911ex38249992 | i(1)-i(2)p(1)-p(2) | sr-srb-b |Perfluorooctanoic acid (PFOA), its salts and PFOA-related compounds (#) | 335-67-1and others | 206-397-9and others | ex29159070 | i(1)-i(2) | sr-b |Terbufos (+) | 13071-79-9 | 235-963-8 | ex29309098 | p(1)-p(2) | b-b |Triflumuron (+) | 64628-44-0 | 264-980-3 | ex29242100 | p(1)-p(2) | b-b |
(3)in Part 2, in the table, the following entries are added:Chemical | CAS No | EC No | CN code(***) | Category (*) | Use limitation (**)1-bromopropane (n-propyl bromide) | 106-94-5 | 203-445-0 | ex29036919 | i | sr1,2-Benzenedicarboxylic acid, di-C6-8-branched alkyl esters, C7-rich | 71888-89-6 | 276-158-1 | ex29173400 | i | sr1,2-Benzenedicarboxylic acid, di-C7-11-branched and linear alkyl esters | 68515-42-4 | 271-084-6 | ex29173400 | i | sr1,2-Benzenedicarboxylic acid, dipentyl ester, branched and linear | 84777-06-0 | 284-032-2 | ex29173400 | i | srAzimsulfuron | 120162-55-2 | | ex29359090 | p | bBis(2-methoxyethyl) phthalate | 117-82-8 | 204-212-6 | ex29173400 | i | srCarbetamide | 16118-49-3 | 240-286-6 | ex29242970 | p | bCarboxin | 5234-68-4 | 226-031-1 | ex29349990 | p | bChlorfenvinphos | 470-90-6 | 207-432-0 | ex29199000 | p | bChlorophene | 120-32-1 | 204-385-8 | ex29081900 | p | bCyfluthrin | 68359-37-5 | 269-855-7 | ex29269070 | p | srCyproconazole | 94361-06-5 | | ex29339980 | p | bDiisopentyl phthalate | 605-50-5 | 210-088-4 | ex29173400 | i | srDipentyl phthalate | 131-18-0 | 205-017-9 | ex29173400 | i | srDiuron | 330-54-1 | 206-354-4 | ex29242100 | p | srEsbiothrin | 260359-57-7 | | ex29162000 | p | bEthametsulfuron-methyl | 97780-06-8 | | ex29359090 | p | bEtridiazole | 2593-15-9 | 219-991-8 | ex29349990 | p | bFamoxadone | 131807-57-3 | | ex29349990 | p | bFenbuconazole | 114369-43-6 | 406-140-2 | ex29339980 | p | bFenoxycarb | 72490-01-8 | 276-696-7 | ex29242970 | p | bFluquinconazole | 136426-54-5 | 411-960-9 | ex29335995 | p | bIndoxacarb | 173584-44-6144171-61-9 | | ex29349990 | p | srIsopyrazam | 881685-58-1 | | ex29331990 | p | bLufenuron | 103055-07-8 | 410-690-9 | ex29242100 | p | bMetosulam | 139528-85-1 | 410-240-1 | ex29359030 | p | bMyclobutanil | 88671-89-0 | 410-400-0 | ex29339980 | p | bn-pentyl-isopentyl phthalate | 776297-69-9 | | ex29173400 | i | srPencycuron | 66063-05-6 | 266-096-3 | ex29242100 | p | bPhosmet | 732-11-6 | 211-987-4 | ex29309098 | p | bProchloraz | 67747-09-5 | 266-994-5 | ex29332990 | p | bProfoxydim | 139001-49-3 | | ex29349990 | p | bSpirodiclofen | 148477-71-8 | | ex29322090 | p | bTerbufos | 13071-79-9 | 235-963-8 | ex29309098 | p | bTriflumizole | 68694-11-1 | | ex29332990 | p | bTriflumuron | 64628-44-0 | 264-980-3 | ex29242100 | p | b
(4)in Part 2, in the table, the entries for bromoxynil, epoxiconazole and nonylphenol ethoxylates are replaced by the following entries:Chemical | CAS No | EC No | CN code(***) | Category (*) | Use limitation (**)Bromoxynil and its butyryl, heptanoyl and octanoyl esters | 1689-84-53861-41-456634-95-81689-99-2 | 216-882-7223-374-9260-300-4216-885-3 | ex29269070 | p | bEpoxiconazole | 135319-73-2133855-98-8 | 406-850-2 | ex29349990 | p | bNonylphenol ethoxylates (C2H4O)nC15H24O | 9016-45-926027-38-368412-54-437205-87-1127087-87-0and others | 500-024-6500-045-0500-209-1932-337-2500-315-8and others | ex34024200ex39072911ex38249992 | ip | srb
(5)in Part 2, in the table, the following entries are deleted:Chemical | CAS No | EC No | CN code(***) | Category (*) | Use limitation (**)Bis(pentabromophenyl) ether | 1163-19-5 | 214-604-9 | ex29093038 | i(1)-i(2) | sr-bPerfluorooctanoic acid (PFOA), its salts and PFOA-related compounds | 335-67-1and others | 206-397-9and others | ex29159070and others | i(1)-i(2) | sr-b
(6)in Part 3, in the table, the following entries are added:Chemical | Relevant CAS number(s) | HS codePure substance (**) | HS codeMixtures containing substance (**) | CategoryBis(pentabromophenyl) ether (decabromodiphenyl ether) | 1163-19-5 | 2909.30 | 3824.99 | IndustrialPerfluorooctanoic acid (PFOA), its salts and PFOA-related compounds | 335-67-1and others | 2915.90and others | | Industrial
Annex I to Regulation (EU) No 649/2012 is amended as follows:
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