Commission Implementing Regulation (EU) 2021/1165 of 15 July 2021 authorising certain products and substances for use in organic production and establishing their lists (Text with EEA relevance)

Article 1

Active substances in plant protection products

For the purposes of point (a) of Article 24(1) of Regulation (EU) 2018/848, only the active substances listed in Annex I to this Regulation may be contained in plant protection products used in organic production as set out in that Annex, provided that those plant protection products:

(a) have been authorised pursuant to Regulation (EC) No 1107/2009 of the European Parliament and of the Council (¹);

(b) are used in accordance with the conditions for use as specified in the authorisations of the products containing them, granted by the Member States; and

(c) are used in compliance with the conditions set out in the Annex to Commission Implementing Regulation (EU) No 540/2011 (²).

Article 2

Fertilisers, soil conditioners and nutrients

For the purposes of point (b) of Article 24(1) of Regulation (EU) 2018/848, only the products and substances listed in Annex II to this Regulation may be used in organic production as fertilisers, soil conditioners and nutrients for plant nutrition, litter improvement and enrichment or algae cultivation or husbandry environment of aquaculture animals, provided that they are compliant with the relevant provisions of Union law, in particular with Regulation (EC) No 2003/2003 of the European Parliament and of the Council (³), the relevant applicable Articles of Regulation (EU) 2019/1009 of the European Parliament and of the Council (⁴), Regulation (EC) No 1069/2009 of the European Parliament and of the Council (⁵) and Commission Regulation (EU) No 142/2011 (⁶) and, where applicable, in accordance with national provisions based on Union law.

Article 3

Non-organic feed material of plant, algal, animal or yeast origin or feed material of microbial or mineral origin

For the purposes of point (c) of Article 24(1) of Regulation (EU) 2018/848, only the products and substances listed in Part A of Annex III to this Regulation may be used in organic production as non-organic feed material of plant, algal, animal or yeast origin or as feed material of microbial or mineral origin, provided that their use is in accordance with the relevant provisions of Union law, in particular Regulation (EC) No 767/2009 of the European Parliament and of the Council (⁷) and, where applicable, in accordance with national provisions based on Union law.

Article 4

Feed additives and processing aids

For the purposes of point (d) of Article 24(1) of Regulation (EU) 2018/848, only the products and substances listed in Part B of Annex III to this Regulation may be used in organic production as feed additives and processing aids used in animal nutrition, provided that their use is in accordance with the relevant provisions of Union law, in particular Regulation (EC) No 1831/2003 of the European Parliament and of the Council (⁸) and, where applicable, in accordance with national provisions based on Union law.

Article 5

Products for cleaning and disinfection

Article 6

Food additives and processing aids

For the purposes of point (a) of Article 24(2) of Regulation (EU) 2018/848, only the products and substances listed in Part A of Annex V to this Regulation may be used as food additives, including food enzymes to be used as food additives, and processing aids in the production of processed organic food, provided that their use is in accordance with the relevant provisions of Union law, in particular Regulation (EC) No 1333/2008 of the European Parliament and of the Council (⁹) and, where applicable, in accordance with national provisions based on Union law.

Article 7

Non-organic agricultural ingredients to be used for the production of processed organic food

For the purposes of point (b) of Article 24(2) of Regulation (EU) 2018/848, only the non-organic agricultural ingredients listed in Part B of Annex V to this Regulation may be used for the production of processed organic food, provided that their use is in accordance with the relevant provisions of Union law and, where applicable, in accordance with national provisions based on Union law.

The first paragraph is without prejudice to the detailed requirements for organic production of processed food provided in Section 2 of Part IV of Annex II to Regulation (EU) 2018/848. In particular, the first paragraph shall not apply to non-organic agricultural ingredients that are used as food additives, processing aids or products and substances referred to in point 2.2.2 of Part IV of Annex II to Regulation (EU) 2018/848.

Article 8

Processing aids for the production of yeast and yeast products

For the purposes of point (c) of Article 24(2) of Regulation (EU) 2018/848, only the products and substances listed in Part C of Annex V to this Regulation may be used as processing aids for the production of yeast and yeast products for food and feed, provided that their use is in accordance with the relevant provisions of Union law and, where applicable, in accordance with national provisions based on Union law.

Article 9

Products and substances for use in organic production of wine

For the purposes of point 2.2 of Part VI of Annex II to Regulation (EU) 2018/848, only the products and substances listed in Part D of Annex V to this Regulation may be used for the production and conservation of organic grapevine products as referred to in Part II of Annex VII to Regulation (EU) No 1308/2013, provided that their use is in accordance with the relevant provisions of Union law, in particular within the limits and conditions set out in Regulation (EU) No 1308/2013 and Commission Delegated Regulation (EU) 2019/934 (¹⁰) and, where applicable, in accordance with national provisions based on Union law.

Article 10

Procedure to grant specific authorisations for the use of products and substances in certain areas of third countries

The Commission shall analyse the dossier referred to in paragraph 1. The Commission shall authorise the product or substance in the light of the specific conditions referred to in the dossier only if its analysis concludes, as a wholethat:

(a) such specific authorisation is justified in the area concerned;

(b) the product or substance described in the dossier complies with the principles laid down in Chapter II, the criteria set out in Article 24(3) and the condition set out in Article 24(5) of Regulation (EU) 2018/848; and

(c) the use of the product or substance is in accordance with the relevant provisions of Union law, in particular, for active substances contained in plant protection products, with Regulation (EC) No 396/2005 of the European Parliament and of the Council (¹¹).

The authorised product or substance shall be included in Annex VI to this Regulation.

Article 10a

Procedure to grant specific authorisation for the use of products and substances in the outermost regions of the Union

The Commission shall analyse the dossier referred to in paragraph 1. The Commission shall authorise the product or substance in the light of the specific conditions referred to in the dossier only if its analysis concludes, as a whole that:

(a) such specific authorisation is justified in the outermost region concerned;

(b) the product or substance described in the dossier complies with the principles laid down in Chapter II, the criteria set out in Article 24(3) and the condition set out in Article 24(5) of Regulation (EU) 2018/848; and

(c) the use of the product or substance is in accordance with the relevant provisions of Union law, in particular, for active substances contained in plant protection products, with Regulation (EC) No 396/2005. The authorised product or substance shall be included in Annex VI to this Regulation.

Article 11

Repeal

Regulation (EC) No 889/2008 is repealed.

However, Annex VII shall continue to apply until 31 December 2027 and Annex IX shall continue to apply until 31 December 2023.

Article 12

Transitional provisions

Article 13

Entry 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.

It shall apply from 1 January 2022.

Article 5 (1), (2) and (3) shall apply from 1 January 2028.

Article 7 shall apply from 1 January 2024.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

The active substances listed in this Annex may be contained in plant protection products used in organic production as set out in this Annex, provided that these plant protection products are authorised pursuant to Regulation (EC) No 1107/2009. These plant protection products shall be used in compliance with the conditions set out in the Annex to Implementing Regulation (EU) No 540/2011 and in accordance with the conditions specified in the authorisations granted by the Member States where they are used. More restrictive conditions for use in organic production are specified in the last column of each table below.

In accordance with Article 9(3) of Regulation (EU) 2018/848, safeners, synergists and co-formulants as components of plant protection products, and adjuvants that are to be mixed with plant protection products shall be allowed for use in organic production, provided that they are authorised pursuant to Regulation (EC) No 1107/2009. The substances in this Annex may only be used for the control of pests as defined in Article 3(24) of Regulation (EU) 2018/848.

In accordance with point 1.10.2 of Part I of Annex II to Regulation (EU) 2018/848, these substances may only be used where plants cannot be adequately protected from pests by measures provided for in point 1.10.1 of that Part I, in particular by the use of biological control agents, such as beneficial insects, mites and nematodes complying with the provisions of Regulation (EU) No 1143/2014 of the European Parliament and of the Council (¹²).

For the purposes of this Annex, active substances are divided into following subcategories:

1. Basic substances

Basic substances listed in Part C of the Annex to Implementing Regulation (EU) No 540/2011, from plant or animal origin and based on food as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (¹³) may be used for plant protection in organic production. Such basic substances are marked with an asterisk in the table below. They shall be used in accordance with the uses, conditions and restrictions set in the relevant review reports (¹⁴) and taking into account the additional restrictions, if any, in the last column of the table below.

Other basic substances listed in Part C of the Annex to Implementing Regulation (EU) No 540/2011 may be used for plant protection in organic production only when they are listed in the table below. Such basic substances shall be used in accordance with the uses, conditions and restrictions set in the relevant review reports³ and taking into account the additional restrictions, if any, in the right column of the table below.

Basic substances shall not be used as herbicides.

2. Low risk active substances

Low risk active substances, other than micro-organisms, listed in Part D of the Annex to Implementing Regulation (EU) No 540/2011 may be used for plant protection in organic production when they are listed in the table below or elsewhere in this Annex. Such low risk active substances shall be used in accordance with the uses, conditions and restrictions pursuant to Regulation (EC) No 1107/2009 and taking into account the additional restrictions, if any, in the last column of the table below.

3. Micro-organisms

All micro-organisms listed in Parts A, B and D of the Annex to Implementing Regulation (EU) No 540/2011 may be used in organic production, provided that they are not from GMO origin and only when used in accordance with the uses, conditions and restrictions set in the relevant review reports³. Micro-organisms including viruses are biological control agents that are considered as active substances by Regulation (EC) No 1107/2009.

4. Active substances not included in any of the above categories