EN   EN 
 
 
   
Brussels, XXX   
[…](2023) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on […]amending and correcting Implementing Regulation (EU) 2021/1165 authorising 
certain products and substances for use in organic production and establishing their lists  
 
(Text with EEA relevance)  
This draft has not been adopted or endorsed by the European Commission.  
Any views expressed are the preliminary views of the Commission services  
and may not in any circumstances be regarded as stating an official position  
of the Commission. The information  transmitted is intended only for the  
Member State or entity to which it is addressed for discussions and may  
contain confidential and/or privileged material.    
EN 0  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
on […]amending and correcting Implementing Regulation (EU) 2021/1165 authorising 
certain products and substances for use in organic production and establishing their lists  
 
(Text with EEA relevance)  
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 834/20071, and in particular Article 24(9) thereof,  
Whereas:  
(1) In accordance with the procedure prov ided 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 Impleme nting Regulation (EU) 2021/11652. 
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,3 EGTOP recommended that all low -risk substances in accordance with 
Regulation (EC) No 1107/2009  of the European Parliament and of the Council4 from 
plant or animal origin (not from GMO origin), may be used in organic production 
without an additional evalua tion 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 Regul ation (EC) No 
1107/2009 under low-risk substance s in plant protection product s. 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 
                                                 
1 OJ L 150, 14.6.2018 , p. 1.  
2 Commission Implementing Regulation (EU) 2021/1165 of 15  July 2021 authorising certain products 
and substances for use in organic  production and establishing their lists (OJ L 253, 16.7.2021, p. 13 –
48).  
3 EGTOP final report on Fertilisers IV and Plant Protection Products VI and EGTOP final report on Plant 
Protection Products VII and Fertilisers V: https://agriculture.ec.europa.eu/farming/organic -farming/co -
operation -and-expert -advice/egtop -reports_en . 
4 Regulation (EC) No 1107/2009 of the European Parliament and o f the Council concerning the placing 
of plant protection products on the market and repealing Council Directives 79/117/EEC and 
91/414/EEC (OJ L309 , 24.11.2009, p .1).  
EN 1  EN replaced by ‘Composted or fermented bio -waste ’ to allow for other sources of bio -
waste than household waste to be used for compost ing or ferment ing in organic 
production.  
(5) In its recommendations with regard to fertilisers, soil conditioners and nutrients  
EGTOP also recommended , that the use of selenium in case of deficiency of the soils 
employed  for animal rearing and/or grazing is in li ne with the objectives and 
principles of organic production.  The use of th at substance should therefore be 
authorised.  
(6) Based on recommendations from EGTOP regarding  feed and pet food5, 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 tartrates on products of plant o rigin.  
(8) EGTOP further  recommended that sodium tartrates, potassium tartrate s, and potassium  
sodium tartrates should be authorised from 1 January 2027 only if they are  from 
organic production6, 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 
tartrates ’ 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 
authorise d 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 889/20087 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 s hould 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,  
                                                 
5 EGTOP final report on Food VII – Feed V and EGTOP final report on Feed VI and pet Food I: 
https://agriculture.ec.europa.eu/farming/organic -farming/co -operation -and-expert -advice/e gtop-
reports_en . 
6 EGTOP final report on Food VI II: https://agriculture.ec.europa.eu/farming/organic -farming/co -
operation -and-expert -advice/egtop -reports_en . 
7 Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the 
implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of 
organic products with regard to organic prod uction, labelling and control (OJ L 250, 18.9.2008, p. 1).   
EN 2  EN HAS ADOPTED THIS REGULATION:  
Article 1  
Amendments to Implementing Regulation (EU) 202 1/1165  
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 2  
Corrections to Implementing Regulation (EU) 2021/1165  
Point 1 (B asic 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  (*) 
(*) Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 
December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 
1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 
and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22). ’; 
 
(2) the following entr y 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   
EN 3  EN ’. 
 
 
Article 3  
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 . 
 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN