EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
authorising certain products and substances for use in organic production and 
establishing their lists  
(Text with EEA relevance)  
EN  EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
authorising certain products and substances for use in organic production and 
establishing their lists 
(Text with EEA relevance)  
EN 
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 a nd labelling of organic products and repealing Council 
Regulation (EC) No 834/20071 , and in particular Article 24(9) and point (a) of Article 39(2) 
thereof,  
Whereas:  
(1) Pursuant to Article 9(3) of Regulation (EU) 2018/848, only products and substances 
author ised under Article 24 of that Regulation may be used in organic production 
provided that their use in non -organic production has also been authorised in 
accordance with relevant provisions of Union law.  The Commission has already 
evaluated the use of certain products and substances in organic production on the basis 
of the objectives and principles laid down in Council Regulation (EC) No 834/20072. 
The selected products and substances were consequently authorised under specific 
conditions by Commission  Regulation (EC) No 889/20083 and listed in certain 
Annexes  to that Regulation . The objectives and principles laid down in Regulation 
(EU) 2018/848 are similar to th ose in Regulation (EC) No 834/2007 . As it is necessary 
to ensure the continuity of organic production, th ose products and substances should 
be included in the restrictive lists to be established on the basis of Regulation  (EU) 
2018/848 . 
(2) In addition, in accordance with Article 24(7) of Regulation (EU) 2018/848, Member 
States have submitted dossie rs on certain products and substances to the Commission 
and to the other Member States, in view of their authorisation and inclusion in the lists 
to be established under that Regulation.  
(3) Under certain circumstances and conditions set out,  in particular , in point 1.10.2 . of 
Part I of Annex II to Regulation (EU) 2018/848, certain authorised products and 
substances may be used to protect plants . For that purpose , the Commission should 
authorise active substances to be used in plant protection products as referred to  in 
                                                 
1 OJ L 150, 14.6.2018, p. 1 . 
2 Council Regulation (EC) No 834/2007 of  28 June 2007 on organic production and labelling of organ ic 
products  and repealing Regulation  (EEC) No  2092/91  (OJ L 189, 20.7.2007 , p. 1). 
3 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 production, labelling and control  (OJ L 250, 18.9.2008, p. 1).  EN 2  EN point (a) of Article 24(1) of Regulation (EU) 2018/848  and establish the list of those 
active substances .  
(4) Under certain circumstances and conditions set out,  in particular , in point 1.9.3 of Part 
I, points 1.9.1.2(b), 1.9.2.2(d), 1.9.3.2(b) a nd 1.9.5.2(a) of Part II and points 2.2.2(c)  
and 2.3.2 and the second indent of the fourth paragraph of point 3.1.5.3 of Part III of 
Annex II to Regulation (EU) 2018/848, certain fertilisers, soil conditioners and 
nutrients may be used for plant nutrition,  litter improvement and enrichment, algae 
cultivation or husbandry environment of aquaculture animals. For that purpose , the 
Commission should authorise fertilisers, soil conditioners and nutrients as referred to  
in point (b) of Article 24(1) of Regulation  (EU) 2018/848  and establish their list . 
(5) Under certain circumstances and conditions set out,  in particular , in points 1.4.1(i) and 
1.5.2.3 of Part II, point 3.1.3.1(d) of Part III and point 2.3 of Part V of Annex II to 
Regulation (EU) 2018/848, certain non -organic feed material s of plant, algal, animal 
or yeast origin, feed material s of microbial or mineral origin, feed additives and 
processing aids may be used for animal nutrition. For that purpose , the Commission 
should authorise non -organic feed material s of plant, algal, animal or yeast origin, feed 
material s of microbial or mineral origin and feed additives and processing aids as 
referred to  in points (c) and (d) of Article 24(1) of Regulation (EU) 2018/848  and 
establish their lists . 
(6) In addition, some non-organic feed material s are directly authorised in accordance 
with Regulation (EU) 2018/848. For the sake of clarity, th ose feed materials should 
also be listed together with the feed materials authorised by this Regulation, with a 
reference to the spec ific provisions of Regulation (EU) 2018/848.  
(7) Under certain circumstances and  conditions set out,  in particular , in points 1.11 of Part 
I, points 1.5.1.6, 1.5.1.7 and 1.9.4.4(c) of Part II, point 3.1.4.1(f) of Part III, point 2.2.3 
of Part IV, point 2.4 of Part V and point 1.4 of Part VII of Annex II and points 4.2 and 
7.5 of Annex III to Regulation (EU) 2018/848, only certain products and substances 
may be used for cleaning and disinfection. For that purpose,  the Commission should 
authorise products for cle aning and disinfection as referred to  in points (e), (f) and (g)  
of Article 24(1) of Regulation (EU) 2018/848  and establish their lists . 
(8) Certain products for cleaning and disinfection of buildings and installations for 
livestock, aquaculture animals and se aweed production have been evaluated and listed 
in Annex VII to Regulation (EC) No 889/2008. However , products for cleaning and 
disinfection of buildings and installations used for plant production  and of processing 
and storage facilities are so far evalua ted and authorised only by Member States. 
Before authorising th ose products in organic production, an evaluation should be done 
at Union level by the Commission assisted by the E xpert Group for Technical Advice 
on Organic Production . That evaluation should  include a revision of all existing 
authorised products and substances for cleaning and disinfection.  
(9) For the sake of ensuring the continuity of organic production , the products listed in 
Annex VII to Regulation (EC) No 889/2008 and th ose authorised at Mem ber States’ 
level should continue to be authorised until 31 December 2023 to allow the 
establishment of the lists of products for cleaning and disinfection in accordance with 
the provisions laid down in points (e), (f) and (g) of Article 24(1) of Regulatio n (EU) 
2018/848. Nevertheless, those products must comply with the relevant requirements  of 
Union law, in particular Regulation (EC) No 648/2004 of the European Parliament and EN 3  EN of the Council4 and Regulation (EU) No 528/2012 of the European Parliament and o f 
the Council5 and with the organic criteria laid down in Chapter II and points (a) and 
(b) of Article 24(3) of Regulation (EU) 2018/848.  
(10) Under certain circumstances and conditions set out,  in particular , in points 2.2.1 and 
2.2.2(a) of Part IV of Annex II  to Regulation (EU) 2018/848, certain food additives, 
including food enzymes to be used as food additives, and processing aids may be used 
in the production of process ed organic food. For that purpose , the Commission should 
authorise food additives and processing aids as referred to  in point (a) of Article 24(2) 
of Regulation (EU) 2018/848  and establish their list . 
(11) Food additives and food processing aids used in the production of processed organic 
food were listed respectively in sections A , B and C  of Annex VIII to Regulation (EC) 
No 889/2008. However, according to their uses and functions in the final product, 
certain of th ose products might be classified as additives and not as processing aids. 
This classification needs a specific and exhaustive analysis of th ose products in the 
production of processed organic food. Such analysis should be conducted on all 
products listed as processing aids in Regulation (EC) No 889/2008. That process will 
take time a nd cannot be completed  before the date of  application of Regulation (EU) 
2018/848. Consequently, the products currently listed as processing aids in Regulation 
(EC) No 889/2008 will be listed as processing aids in this Regulation until a  specific 
and exhau stive analysis has been carried out.  
(12) Under certain circumstances and conditions set out,  in particular , in point 2.2.1 of Part 
IV of Annex II to Regulation (EU) 2018/848, certain non -organic agricultural 
ingredients may be used for the production of proces sed organic food. For that 
purpose , the Commission should authorise such non-organic agricultural ingredients as 
referred to  in point (b) of Article 24(2) of Regulation (EU) 2018/848  and establish 
their list. The dossiers on non -organic agricultural ingred ients to be used for the 
production of processed organic food that have been submitted by Member States in 
accordance with Article 24(7) of Regulation (EU) 2018/848 were evaluated within the 
Committee on Organic Production. The selected products and substa nces that comply  
with the objectives and principles laid down in Regulation (EU) 2018/848 should be 
included in the restrictive list to be established by  this Regulation, where necessary  
under specific conditions.  
(13) However, i n order to give enough time to o perators to adapt to the new restrictive list 
of authorised non -organic agricultural ingredients  and, in particular , to find a source of 
agricultural ingredients that have been produced in accordance with Regulation (EU) 
2018/848, it is appropriate that th e list of  non-organic agricultural ingredients 
authorised for use in processing of organic food by this Regulation appl ies from 1 
January 2024.  
(14) Given the composition of certain non -organic agricultural ingredients, some of their 
uses in processed organic f ood may correspond to uses as food additives, food 
processing aids or products and substances referred to in point 2.2.2 of Part IV of 
Annex II to Regulation (EU) 2018/848. Those uses require a specific authorisation in 
accordance with point 2.2 of Part IV  of Annex II to Regulation (EU) 2018/848 and 
                                                 
4 Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on 
detergents  (OJ L 104, 8.4.2004, p. 1 ). 
5 Regulation (EU) No  528/2012 of th e European Parliament and of the Council of 22  May 2012 
concerning the making available on the market and use of biocidal products ( OJ L 167, 26.6.2012, p. 1 ). EN 4  EN such uses should  not be allowed via the authorisation of  non-organic agricultural 
ingredients.  
(15) Under certain circumstances and conditions set out,  in particular , in point 1.3(a) of 
Part VII of Annex II to Regulation (EU) 2018/848, certain processing aids may be 
used for the production of yeast and yeast products. For that purpose,  the Commission 
should authorise processing aids for the production of yeast and yeas t products as 
referred to  in point (c) of Article 24(2) of Regulation (EU) 2018/848  and establish 
their list . 
(16) In accordance with  point 2.2 of Part VI of Annex II to Regulation (EU) 2018/848, only 
products and substances authorised pursuant to Article 24 of that Regulation for use in 
organic production may be used for the making of products of the wine sector as 
referred to point (l) of Article 1(2) of Regulation (EU) No 1308/2013 of the European 
Parliament and of the Council6. For that purpose , the Commissi on should authorise 
such products and substances  and establish their list . 
(17) Article 45(2) of Regulation (EU) 2018/848 empowers the Commission to grant 
specific authoris ations  for the use of products and substances in third countries and in 
the outermost reg ions of the Union. How to initiate t he procedure to be followed by 
Member States in respect of  the outermost regions of the Union is set out in Article 
24(7) of that Regulation. However, the procedure to be followed for such 
authorisation s in respect of  third countries is not detailed  in Regulation (EU) 
2018/848 . Therefore, it is appropriate to establish th at procedure in this Regulation, in 
line with the procedure to be followed to authorise products and substances for use in 
organic production in the Unio n, as set out  in Article 24 of Regulation (EU) 2018/848.  
As those authorisations may be granted  for a renewable period of 2 years , it is 
appropriate, in order  to avoid confusion with products and substances authorised 
without time limitation , to list the r elevant  products and substances  in a dedicated 
Annex.  
(18) In the interest of clarity and legal certainty, Regulation (EC) No 889/2008 should be 
repealed. However, as the list of products for cleaning and disinfection will not be 
established before 1 January 20 24, Annex VII to Regulation (EC) No 889/2008 should 
continue to apply until 31 December 2023. In that contex t, it is appropriate to specify 
that products listed in that Annex which  are not authorised  pursuant to  Regulation 
(EU) No 528/2012 , cannot be used as biocidal products . Furthermore, the list of non -
organic agricultural ingredients to be used for the production of processed organic 
food established by this Regulation will only apply from 1 January 2024 . Therefore , it 
is appropriate to provide that pro cessed organic food that has been produced before 1 
January 2024 with non -organic agricultural ingredients listed in that Annex  may be 
placed on the market after that date until the stocks are exhausted . 
(19) The certificate to be issued to operators by the com petent authorities,  or, where 
appropriate, the  control authorities or control bodies in accordance with Article 35(1) 
of Regulation (EU) 2018/848 can be issued from 1 January 2022 . However, it  will not 
be provided to all operators concerned on that day. Fo r the sake of ensuring the 
continuity of organic production and by way of derogation from Article 35(2) of 
Regulation (EU) 2018/848, the documentary evidence issued to operators by the 
                                                 
6 Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013  
establishing a common organisation of the markets in agricultural products and repealing Council 
Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 
347, 20.12.2013, p. 671).  EN 5  EN control authorities or control bodies in accordance with Article 68 of Regulation (EC) 
No 889/2008 before 1 January 2022 should remain valid until the end of the validity 
period. However , as pursuant to Article 38(3) of Regulation (EU) 2018/848 operators 
are to  be subject to a verification of compliance at least once a year a nd, in accordance 
with Article 38(5) of that Regulation , the delivery of the certificate is to be based on 
the results of th at verification , the validity should not go beyond 31 December 2022 .  
(20) In the interest of clarity and legal certainty, this Regulation should apply from the date 
of application of Regulation (EU) 2018/848.  However, for the reasons set out in recital 
18 of this Regulation, the provisions referring to the lists of p roducts for cleaning and 
disinfection  and to the list of non -organ ic agricultural ingredients to be used for the 
production of processed organic food  should apply from 1 January 2024.  
(21) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee on Organic Production,  
HAS ADOPTED THIS R EGULATION:  
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 Council7; 
(b) are used in accordance with  the conditions for use as specified in the authorisations 
of the products containing th em, 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 540/20118. 
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 the y are compliant with the relevant provisions of Union law, in particular with 
Regulatio n (EC) No 2003/2003 of the European Parliament and of the Council9, the relevant 
applicable Articles of Regulation (EU) 2019/1009 of the European Parliament and of the 
                                                 
7 Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 
concerning the placing of plant protection products on the market  (OJ L 309, 24.11.2009, p. 1 ). 
8 Commission Implementing Regulation (EU) No 540/2011  of 25 May 2011 implementing Regulation 
(EC) No 1 107/2009 of the European Parliament and of the Council as regards the list of approved active 
substances ( OJ L 153, 11.6.2011, p. 1).  
9 Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 
relating to fertilisers  (OJ L 304, 21.11.2003, p. 1).  EN 6  EN Council10, Regulation (EC) No 1069/2009 of the European Parliament and of the Council11 
and Commission Regulation (EU) No 142/201112 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 as feed material of 
microbial or mineral origin  
For t he 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 Council13 and, where applicable, in accor dance 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 ma y 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 Council14 and, where applicable, in 
accordance with national provisions based on Union law.  
Article 5  
Products for cleaning and disinfection  
1. For the purposes of point (e) of Article 24(1) of Regulation (EU) 2018/848,  only the 
products listed in Part A  of Annex IV to this Regulation may be used for the cleaning 
                                                 
10 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down 
rules on the making available on the market of EU fertilising products and amending Regulations (EC) 
No 1069/2009 and (EC) No 1 107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L170 
25.6.2019, p. 1).  
11 Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21  October 2009 
laying down health rules as regards animal by -products and derived products not intended for human 
consumption and repealing Regulation (EC) No  1774/2002  (OJ L 300, 14.11.2009, p. 1).  
12 Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 
1069/2009 of the European Parliament and of the Council lay ing down health rules as regards animal 
by-products and derived products not intended for human consumption and implementing Council 
Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border 
under that Directive (O J L 54, 26.2.2011, p. 1).  
13 Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the 
placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 
1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council 
Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 
2004/217/EC  (OJ L 229, 1.9.2009, p. 1 ). 
14 Regulation (EC) No 1831/2003 of the European Parliament an d of the Council of 22 September 2003 
on additives for use in animal nutrition  (OJ L 268, 18.10.2003, p. 29). EN 7  EN and disinfection  of ponds, cages, tanks, raceways, buildings or installations used for 
animal production , provided that those products comply with the  provisions of Union 
law, in particular Regul ation (EC) No 648/2004  and Regulation (EU) No 528/2012 
and, where applicable, in accordance with national provisions based on Union law . 
2. For the purposes of point (f) of Article 24(1) of Regulation (EU) 2018/848,  only the 
products listed in Part B of Annex  IV to this Regulation may be used for the cleaning 
and disinfection of buildings and installations used for plant production, including 
for storage on an agricultural holding , provided that those products comply with the 
provisions of Union law, in partic ular Regulation (EC) No 648/2004  and Regulation 
(EU) No 528/2012 and, where applicable, in accordance with national provisions 
based on Union law . 
3. For the purposes of point (g) of Article 24(1) of Regulation (EU) 2018/848,  only the 
products listed in Part C of Annex IV to this Regulation may be used for cleaning 
and disinfection in processing and storage facilities , provided that those products  
comply with the provisions of Union law, in particular Regulation (EC) No 648/2004  
and Regulation (EU) No 528 /2012 and, where applicable, in accordance with 
national provisions based on Union law . 
4. Pending their inclusion in Part A, B or C of Annex IV to this Regulation, products 
for cleaning and disinfection referred to in points (e), (f) and (g) of Article 24(1)  of 
Regulation (EU) 2018/848 that were authorised for use in organic production under 
Regulation (EC) No 834/2007 or under national law prior to the date of application 
of Regulation (EU) 2018/848 may continue to be used if they comply with the 
relevant pr ovisions of Union law, in particular Regulation (EC) No 648/2004 and 
Regulation (EU) No 528/2012 and, where applicable, in accordance with national 
provisions based on Union law.  
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 
process ed 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 Council15 and, where applicable, in accordance with national provisions bas ed 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 ingre dients 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 
                                                 
15 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on 
food additives  (OJ L 354, 31.12.2008, p. 16 ). EN 8  EN 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 agric ultural 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, pro vided 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) 2019/93416 and, 
where applicable, in accordance with national provisions based on Union law.  
Article 1 0 
Procedure to grant specific authorisations for the use of products and substances in certain 
areas of third countries  
1. Where a control authority or control body r ecognised under Article 46(1) of 
Regulation (EU) 2018/848 considers that a product or substance should be granted a 
specific authoris ation  for use in a certain area outside the Union due to the specific 
conditions set out  in Article 45(2) of that Regulatio n, it may request the Commission 
to carry out an assessment. For that purpose, it shall notify the Commission of a 
dossier describing the product or substance concerned , giving the reasons for such 
specific authorisation and explaining why the products and  substances authorised 
under this Regulation are not adequate to be used due to the specific conditions in the 
relevant area. It shall ensure that the dossier is fit to be made publicly available  
subject to Union and national legislation of the Member Stat es on data protection.  
                                                 
16 Commission Delegated Regulation (EU) 2019/934 of 12 March 2019 supplementing Regulation (EU) 
No 1308/2013 of the European Parliament and of the Council as regards wine -growing areas where the 
alcoholic strength may be increased, authorised oenological pr actices and restrictions applicable to the 
production and conservation of grapevine products, the minimum percentage of alcohol for by -products 
and their disposal, and publication of OIV files  (OJ L 149, 7.6.2019, p.  1). EN 9  EN 2. The Commission shall forward the request  referred to in paragraph 1  to the Member 
States and shall publish  any such request s. 
3. The Commission shall analyse the dossier referred to in paragraph  1. The 
Commission shall authoris e the pro duct 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 area concerned;  
(b) the product or substance described in the dossier compl ies 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 Council17. 
The authorised product or substance shall be included in Annex VI to this 
Regulation.  
4. When the 2 -year period referred to in Article 45(2) of Regulation (EU) 2018/848 
expires, the authorisation shall be automatically renewed for another period of 2 
years, provided that no new elements are available and no Member State or control 
authority or control body recognised under Article 46(1) of Regulation (EU) 
2018/848 has objected, justifying that the conclusion by the Commission referred to 
in paragraph 3 need to be reassessed.  
Article 1 1 
Repeal  
Regulation (EC) No 889/2008 is repealed.  
However, Annexes VII and IX shall continue to apply until 31 December 2023.  
Article 1 2 
Transitional provisions  
1. For the purposes of Article 5(4) of this Regulation, the products for cleaning and 
disinfection listed in Annex VII to Regulation (EC) No 889/2008  may continue to be 
used until 31 December 2023 for the cleaning and disinfection of ponds, cages, 
tanks, raceways, buildings or installations used for animal production , subject to Part 
D of Annex IV to this Regulation .  
2.  For the purposes of point (b) of Article 24(2) of Regulation (EU) 2018/848 , the non -
organic agricultural ingredients listed in Annex IX to Regulation (EC) No 889/2008  
may continue to be used for the production of processed organic food until 31 
December 2023 . Processed organic food that has been produced before 1 January 
                                                 
17 Regulation (EC) No 396/2005 of th e European Parliament and of the Council of 23  February 2005 on 
maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending 
Council Directive 91/414/EEC  (OJ L 70, 16.3.2005, p. 1 ). EN 10  EN 2024 with those  non-organic agricultural ingredients may be placed on the market 
after that date until the stocks are exhausted.  
3. Documentary evidence issued in accordance with Article 68 of Regulation (EC) No 
889/2008 prior to 1 January 20 22 shall remain valid until the end of its validity 
period  but not beyond 31 December 2022 . 
Article 1 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 . 
It shall apply from 1 January 2022 .  
However, Article 5(1), (2) and (3) and Article 7 shall apply from 1 January 2024.  
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