Contents
THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007note, and in particular Article 24(9) thereof,Whereas:
(1)In accordance with the procedure provided for in Article 24(7) of Regulation (EU) 2018/848, Member States have submitted dossiers on certain substances to the other Member States and the Commission, in view of their authorisation and inclusion in Annexes I, II, III and V to Commission Implementing Regulation (EU) 2021/1165note. Those dossiers have been examined by the Expert Group for Technical Advice on Organic Production (EGTOP) and the Commission.
(2)In its recommendations with regard to active substances contained in plant protection products,note EGTOP recommended that all low-risk substances in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Councilnote from plant or animal origin (not from GMO origin), may be used in organic production without an additional evaluation by EGTOP.
(3)Sodium hydrogen carbonate is listed in point 1 of Annex I to Implementing Regulation (EU) 2021/1165 as a basic substance that may be used in organic production as a plant protection product. Sodium hydrogen carbonate is also listed in Regulation (EC) No 1107/2009 under low-risk substances in plant protection products. It should therefore also be authorised as a low-risk substance in organic production as a plant protection product.
(4)Based on recommendations from EGTOP regarding fertilisers, soil conditioners and nutrients3, the entry ‘Composted or fermented mixture of household waste’ should be replaced by ‘Composted or fermented bio-waste’ to allow for other sources of bio-waste than household waste to be used for composting or fermenting in organic production.
(5)In its recommendations with regard to fertilisers, soil conditioners and nutrients EGTOP also confirmed, that the use of selenium salts in case of deficiency of the soils employed for animal rearing and/or grazing is in line with the objectives and principles of organic production. The use of that substance should therefore be authorised.
(6)Based on recommendations from EGTOP regarding feed and pet foodnote, the use of the following substances should be authorised: (i) propylene glycol, algal oil and calcium chloride used as feed material; (ii) iron chelate, and iron dextran, copper chelate, manganese chelates, zinc chelates of proteins and selenised yeast as trace elements.
(7)Based on recommendations from EGTOP regarding food5, the use of the following substances should be authorised: (i) ascorbic acid on meat preparations to which other ingredients than additives or salt have been added; (ii) lecithins on animal products; and (iii) potassium sodium tartrate on products of plant origin.
(8)EGTOP further recommended that sodium tartrates, potassium tartrates, and potassium sodium tartrate should be authorised from 1 January 2027 only if they are from organic productionnote, because EGTOP considered the timeframe of three years sufficient to ensure that tartrates from organic origin be available to all operators. The entries ‘sodium tartrates’ and ‘potassium tartrates’ should therefore be amended to introduce these specific conditions and limits, and a new entry ‘potassium sodium tartrate’ should be inserted in the list of ‘Food additives, including carriers’ of Part A of Annex V to Implementing Regulation (EU) 2021/1165.
(9)EGTOP has started the evaluation of substances for cleaning and disinfection to be authorised in organic production. However, it appears that this will require more time than was anticipated in Implementing Regulation (EU) 2021/1165. As the lists of products for cleaning and disinfection will not be established before 1 January 2026, Annex VII to Commission Regulation (EC) No 889/2008note should continue to apply until 31 December 2025. The provisions referring to the lists of products for cleaning and disinfection should therefore only apply from 1 January 2026.
(10)The CAS number for chitosan has been erroneously attributed to chitosan hydrochloride in point 1 (Basic substances) of Annex I to Implementing Regulation (EU) 2021/1165 and the entry for chitosan is therefore missing. These errors need to be corrected.
(11)Implementing Regulation (EU) 2021/1165 should therefore be amended and corrected accordingly.
(12)The measures provided for in this Regulation are in accordance with the opinion of the Organic Production Committee,
HAS ADOPTED THIS REGULATION:
Article 1Amendments to Implementing Regulation (EU) 2021/1165#
Implementing Regulation (EU) 2021/1165 is amended as follows:
(1)in Article 12(1), the date ‘31 December 2023’ is replaced by ‘31 December 2025’;
(2)Article 13 is amended as follows:
(a)the third paragraph is replaced by the following:‘Article 5(1), (2) and (3) shall apply from 1 January 2026.’;
(b)the following fourth paragraph is inserted after the third paragraph:‘Article 7 shall apply from 1 January 2024.’;
(3)Annex I is amended in accordance with Annex I to this Regulation;
(4)Annex II is amended in accordance with Annex II to this Regulation;
(5)Annex III is amended in accordance with Annex III to this Regulation;
(6)Annex V is amended in accordance with Annex IV to this Regulation.
Article 2Corrections to Implementing Regulation (EU) 2021/1165#
Point 1 (Basic substances) of Annex I to Implementing Regulation (EU) 2021/1165 is corrected as follows:
(1)the entry 2C for ‘Chitosan hydrochloride’ is replaced by the following:2C | 70694-72-3 | Chitosan hydrochloride | obtained from Aspergillus or organic aquaculture or from sustainable fisheries, as defined in Article 2 of Regulation (EU) No 1380/2013 of the European Parliament and of the Council
(2)the following entry is added:24C | 9012-76-4 | Chitosan* | obtained from Aspergillus or organic aquaculture or from sustainable fisheries, as defined in Article 2 of Regulation (EU) No 1380/2013
Article 3Entry into force and application#
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Annex I
(1)after the entry ‘20D Ferric pyrophosphate’:24D | 144-55-8 | Sodium hydrogen carbonate |
(2)after the entry ‘28D Aqueous extract from the germinated seeds of sweet Lupinus albus’:| | Other low risk substances from plant or animal origin * | Herbicidal uses not allowed
In the table in point 2 (Low risk active substances) of Annex I to Implementing Regulation (EU) 2021/1165, the following entries are added:
Annex II
(1)the entry for ‘Composted or fermented mixture of household waste’ is replaced by the following:Composted or fermented bio-waste (Directive 2008/98/EC of the European Parliament and of the Council) | product obtained from separate bio-waste collection at source, which has been submitted to composting or to anaerobic fermentation for biogas productiononly vegetable and animal bio-wasteonly when produced in a closed and monitored collection system, accepted by the Member Statemaximum concentrations in mg/kg of dry matter: cadmium: 0,7; copper: 70; nickel: 25; lead: 45; zinc: 200; mercury: 0,4; chromium (total): 70; chromium (VI): not detectable
(2)the following entry is added after the entry “Potassium chloride (muriate of potash)”:Selenium salts | only in case of deficiency in the soils used for animal rearing, and/or grazing or for the production of feed crops
The table of Annex II to Implementing Regulation (EU) 2021/1165 is amended as follows:
III
(1)part A is amended as follows:
(a)in point (1), ‘FEED MATERIALS OF MINERAL ORIGIN’, after the entry ‘11.1.5 Lithothamn’, the following entry is inserted:11.1.6 | Calcium chloride | restricted to use in accordance with Commission Regulation (EU) 2020/354 as feed intended for particular nutritional purposes: reduction of the risk of milk fever and subclinical hypocalcaemiaon dairy cowsuse restricted as selective application(only for individual animals in need and for a limited period)calcium chloride when purified from naturally occurring brine, if available
(b)point (2), ‘OTHER FEED MATERIALS’ is amended as follows:
(i)before the entry ‘10 Meal, oil and other feed materials or fish or other aquatic animals’ origin’, the following entry is added:ex 7.1.4 | Algal oil | oil obtained by extraction from microalgae through fermentationgrowing medium for the fermentation process must not be of GMO origin and should be from organic raw materials, if available
(ii)after the entry ‘ex 12.1.12 yeast products’, the following entry is inserted:13.11.1 | Propylene glycol; [1,2-propanediol]; [propane-1,2-diol] | restricted to use in accordance with Commission Regulation (EU) 2020/354 as feed intended for particular nutritional purposes: reduction of the risk of ketosison dairy cows, ewes and goatsuse restricted to selective application (only to individual animals in need and for a limited period)
(2)in Part B, point (3)(b) ‘Compounds of trace elements’ is amended as follows:
(i)after the entry ‘3b104 Iron (II) sulphate heptahydrate’, the following entries are inserted:3b107 | Iron (II) chelate of protein hydrolysates | from organic soy production, if available3b110 | Iron dextran 10 % | restricted to use in accordance with Commission Regulation (EU) 2020/354 as feed intended for particular nutritional purposes: compensation for insufficient iron availability after birthonly for suckling pigletsgrowing medium for the fermentation process for dextran must be of non-GMO originuse restricted to selective application(only for piglets in need and for a limited period)
(ii)after the entry ‘3b405 Copper (II) sulphate pentahydrate’, the following entry is inserted:3b407 | Copper (II) chelate of protein hydrolysates | from organic soy production, if available
(iii)after the entry ‘3b503 Manganous sulphate, monohydrate’, the following entry is inserted:3b505 | Manganese chelates of protein hydrolysates | from organic soy production, if available
(iv)after the entry ‘3b609 Zinc chloride hydroxide monohydrate’, the following entry is inserted:3b612 | Zinc chelate of protein hydrolysates | from organic soy production, if available
(v)after the entry ‘3b810 Selenised yeast Saccharomyces cerevisiae CNCM I-3060, inactivated’, the following entry is inserted:3b810i | Selenised yeast Saccharomyces cerevisiae CNCM I-3060, inactivated |
Annex III to Implementing Regulation (EU) 2021/1165 is amended as follows:
Annex IV
(1)the entry for ‘E 300 Ascorbic acid’ is replaced by the following:E 300 | Ascorbic acid | products of plant originmeat products (category 08.3) and meat preparations (category 08.2) to which other ingredients than additives or salt have been added |
(2)the entry for ‘E 322 – Lecithins’ is replaced by the following:E 322* | Lecithins | products of plant originproducts of animal origin | only from organic production
(3)the entries for ‘E 335– Sodium tartrates’ and ‘E 336 – potassium tartrates’ are replaced by the following:E 335 | Sodium tartrates | Products of plant origin | from 1 January 2027, only from organic productionE 336 | Potassium tartrates | Products of plant origin | from 1 January 2027, only from organic production
(4)the following entry is inserted after the entry ‘E 336 – potassium tartrates’:E 337 | Potassium sodium tartrate | Products of plant origin | from 1 January 2027, only from organic production
The table in Section A1 (Food additives, including carriers) of Part A of Annex V to Implementing Regulation (EU) 2021/1165 is amended as follows:
Source: EUR-Lex, © European Union, 1998-2026. Reuse authorised under Decision 2011/833/EU.