EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft  
 
COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annex II to Regulation (EU) 2018/848 of the European Parliament and of the 
Council as regards the requirements for record -keeping for operators in organic 
production  
(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.    
EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  DELEGATED  ACT  
Following the adoption of Regulation (EU) 2018/848 , which will enter into application on 1 
January 202 2, it is necessary to adopt a delegated regulation amending that Regulation in 
order to lay down additional rules for operators, groups of operators and subcontractors to 
keep records concerning their organic production to demonstrate compliance  with organic 
production rules.  The o rganic sector needs to have legal certainty on the rules that will apply 
for these  issues and Member States need to have enough time to integrate these rules into their 
national legislation.  
2. CONSULTATIONS  PRIOR  TO THE ADOPTION  OF THE  ACT  
The act was discussed thoroughly with the Member States at the Group of Experts on Organic 
Production as well as with the main organisations representing the organic sector, namely 
IFOAM, COPA -COGECA and EOCC. DG AGRI cooperated close ly with other DGs in the 
field of their specific expertise when drafting these rules. WTO partners were notified and 
general public consultations were carried out.  
3. LEGAL  ELEMENTS  OF THE  DELEGATED  ACT  
This delegated ac t lays down additional rules amendi ng Annex II to Regulation (EU) 
2018/848 as regards the requirements for keeping records to demonstrate compliance with 
organic production rules by operators, groups of operators and sub-contractors in the organic 
production chain.   
EN 2  EN COMMISSION DELEGATED REGULATION (EU) …/...  
of XXX  
amending Annex II to Regulation (EU) 2018/848 of the European Parliament and of the 
Council as regards the requirements for record -keeping for operators in organic 
production  
(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  34(8) thereof,  
Whereas:  
(1) Annex II to Regulation (EU) 2018/84 8 sets out some requirements to keep  records  
concerning certain specific production rules . Records can be relevant for traceability  
purpose s, internal quality control and for the assessment of compliance with the 
detailed organic produ ction rules  set out in that Annex .  
(2) Notwithstanding the provisions on keeping records set out in Article 9(10), point (c) , 
Article 34(5) and Article 39(1) point (a) of Regulation (EU) 2018/84 8, it is necessary 
to detail further the minimum record -keeping  requirements in each production area 
covered by the various p arts of Annex II to that Regulation.  
(3) It is also necessary to introduce certain specific elements to ensure consistency  and a 
harmonised basis for record -keeping , which is  considered crucial to allow operators to 
provide evidence of the effective application of the organic production rules. 
(4) The amen dments made by th is Regulation are without prejudice to the record -keeping 
requirements set out in other Union acts such as those concerning food and food 
safety, feed and feed safety, animal health and welfare , plant health , plant protection  
and plant reproductive material . Hence,  for the purposes of Regulation (EU) 2018/848, 
only th e complementary elements which allow verification of compliance with the 
organic production rules will have to be recorded by those operators already fulfilling 
the record -keeping requirements  under other Union acts, without the need to duplicate 
them . Nevertheless, certain record -keeping requirements are repeated in Annex II to 
Regulation (EU) 2018/848 as amended by this Regulation, because they are relevant 
for o perators in  third countries.  
(5) As regards plant production rules, f or the purpose of recording data on the use of 
fertilisers  and soil conditioners , it is necessary to include certain  application 
parameters given that the use of fertilisers in organic produc tion is subject to  both 
quanti tative and qualitative restrictions , which have to be taken into account when  
agronomical measures are not sufficient to fulfil the nutritional  needs of plants . 
                                                 
1 OJ L 150, 14.6.2018, p. 1.  
EN 3  EN (6) The use of plant protection products  and of  cleaning and disinfe ction products , such as 
biocides and detergents , is subject to restrictions in organic production  and is limited  
to cases whe re preventive measures did not impede the occurrence and spread of pests 
and disease s and in all cases to products and substances  approved pursuant to Article 
24 of Regulation (EU) 2018/848 . Without prejudice to the  requireme nts on record -
keeping set out in Regulation s (EC) No 1107/20092 and (EC) No 852/20043of the 
European Parliament and of the Council , it is necessary to require that operators record 
the detailed application conditions when having to resort to the use of a p lant 
protection product , a biocide or a detergent in order to demonstrate , where  relevant, 
compl iance with the applicable restrictions, the respect of the recommended frequency 
and the pre-harvest period .  
(7) As land p arcels can have different characteristics  and host different crops, agronomic 
conditions can vary. This implies that,  when external input s are applied, their use 
differs from parcel to parcel. Therefore, external inputs should be recorded in relation 
to the p arcel where the input is used  to allow operators to monitor the efficacy and 
provide  appropriate records for traceability purposes  and, where  relevant , documen tary 
eviden ce related to any  derogation from plant production rules obtain ed in accordance 
with point 1.8.5 of Part I of Annex II to  Regulation (EU) 2018/848 .  
(8) When collecting wild plants and their products, it is necessary to require operators to 
keep records of  the species concerned and quantities and periods of collection in a 
specific natural habitat to allow  traceability and verification of compliance with 
natural habitat conditions.  
(9) As regards livestock production rules, i n view of possible deroga tions from those r ules 
granted under points 1.3.4.3, 1.3.4.4 , 1.7. 5, 1.7.8 , 1.9.3.1 (c) and 1.9.4.2 (c) of P art II of 
Annex II  to Regulation (EU) 2018/848 , operators should keep  documentary evidence 
related to such derogations to allow for tracea bility and c ontrol of compliance with the 
applicable  conditions.  
(10) Without prejudice to the requirements of Regulation (E C) No 852/2004  and 
Regulation (EU) 2016/429 of the European Parliament and of the Council4, operators 
should keep detailed records on the origin of animals introduced in the holding and 
their relevant former veterinary records in order to be able to ensure traceability and to 
demonstrate compliance with the specific conditions set out in Part s II and III of 
Anne x II to Regulation (EU) 2018/848 .  
(11) In addition, in order to document  compliance with  the specie s-specific nutritional 
needs and  the relevant nutrition rules set out for the different groups of animals  in Part 
II of Annex II to Regulation (EU) 2018/848, operators should  keep detailed records of 
the feeding regime  and the grazing period s. 
                                                 
2 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 and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 
1). 
3 Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of 
foodstuffs (OJ L 139, 30.4.2004, p. 1).  
4 Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal 
diseases and amending and repealing certain acts in the area of animal health (Animal Health Law) (OJ L 84, 31.03.2016, p. 1) .  
EN 4  EN (12) Without prejudice to the record -keeping  and identificati on requirements set out in 
Regulation s (EC ) No 852/2004 and (EU) 2016/429, Regulation (EC) No 1760/2000  of 
the Eur opean Parliament and Council5 and Directive 2001/82 /EC of the European 
Parliament and Council6, in view of  the specific limitations set under organic 
production rules, it is appropriate to lay down some specific requirement s for record - 
keeping of the veterinary treatments and of cleaning and disinfection of the  building s, 
installations and animals  in order to enable operators to demonstrate to the competent 
authority or control body that the relevant requirements are being fulfilled while 
allowing to verify efficacy and the respect of specific withdrawal periods.  
(13) Without  prejud ice to the  traceability requirements set out in Regulation (EC) No 
178/2002  of the European Parliament and of the Council7, in order to allow 
traceability and verification of compliance with  organic production rules, including 
those on the  conversion periods for the various species, it is necessary  that operators 
keep detailed records on any animal coming to or leaving the holding .  
(14) Among the housing and husbandry requirements for poultry , there are specific 
requirements that apply to certain rearing systems as regards the  respect of a period of 
emptiness . The relevant documentary evidence should be kept to allow proper 
monitoring.  
(15) Given the relevance of the position of apiaries in areas that should ensure availability 
of nectar and pollen from organic ally produced crops or from natur al uncontaminated 
areas or from crops under low environmental impact methods to avoid any 
contamination of apia ries, it is necessary  that operators keep a map of the areas used as 
well as records of any external input used and operations performed on the beehives . 
(16) As regards production rules for aquaculture animals, i n view of possible derogations 
from those rules  granted under points 3.1.2.1(d) and (e) of Part II I of Annex II  to 
Regulation (EU) 2018/848 , operators should keep  documentary evidence related to 
such derogations to allow for traceability and control of compliance with the 
applicable conditions.  
(17) In particular, the use of external inputs is subject to restrictions under Regulation (EU) 
2018/848 and is to be recorded as in  the case of fertilisers or nutrients used in organic 
algae production , which can only be used when authorised pursuant to  Article 24 of 
that Regulation and which are limited to indoor facilities and to be applied under 
certain conditions . Therefore , operators should record such uses to demonstrate  
compliance with the applicable conditions.  
(18) It is also necessary to set record -keeping requir ements in respect of the specific 
provisions for juveniles for breeding and on -growing purpose s, in particular as regard s 
                                                 
5 Regulation (EC) No 1760/2000 of the European Parliament and of the Council of 17 July 2000 establishing a 
system for the identification and registration of bovine animals and regarding the labelling of beef and beef products and 
repealing Council Regulation (EC) no 820/97 (OJ L 204, 11.08.2000, p. 1).  
6 Directive 2001/82/EC of the European Parliament and of th e Council of 6 November 2001 on the Community code 
relating to veterinary medicinal products (OJ L 311, 28.11.2001, p.1.)  
7 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the 
general principles and  requirements of food law, establishing the European Food Safety Authority and laying down 
procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).  
  
EN 5  EN the precise time of their occurrence during the cycle of production  of animals  and an 
initial period of conversion.  
(19) The feeding regime s of aquaculture animals are intended to address the specific 
nutritional needs  of each specie s at the various stage s of development . Therefore, 
considering the detailed provisions on authorised feed materials , including when from 
non-organic origin, record s of the feeding regime should be kept for each species 
concerned , with data for the various  stages  of development.  
(20) The health care of aquacult ure animals  is based on prevention and monitoring the 
wellbeing of the animals . Therefore , it is  necessary  to keep records of  the various 
actions put in place to limit as much as possible the recourse to veterinary  treatments , 
which are subject to strict limitations in terms of frequency and number depending on 
the duration of the life cycle of the species concerned. The corresponding record -
keeping requirements need to be laid down .  
(21) Proper husbandry practices determine the wellbeing of animals . In the context of 
aquaculture , the quality of water and the limits for stocking densities and relevant 
chemical -physical parameters are fundamental for animal welfare. Therefore , it is 
necessary to have  record s of such data as well as of the type and time of interventions 
carried out to monitor the maintaining  of the best conditions for aquaculture animals 
and the measures taken to respect organic production rules in the different stages of 
development of those animals . In organic aquaculture, the use of aeration is allowed, 
but oxygen use is limited to specific cases . Therefore,  records should be kept on these 
types  of intervention.  
(22) Without prejudice to the record -keeping requirements under Regulation (EC)  No 
852/2004, operators producing organic processed food  and/or organic processed feed 
should keep detailed records to demonstrate compliance with organic production rules , 
in particular concerning precautionary measures put in place to ensure the integrity of 
organic products, the specific conditions for the use of external inputs  and of cleanin g 
and disinfect ion products . Moreover, to allow the proper veri fication of input and 
output balance, operators should  keep available data on the input used and in case of 
composite products , the complete recipes/formulae  as well as, where  applicable,  
documentary evidence on authorisations for the use of non-organic ag ricultural 
ingredients in accordance with Article 25 of Regulation (EU) 2018/84 8. 
(23) Without prejudice to the record -keeping requirements under Regulation (EC) No 
852/2004, operat ors producing organic wine should  keep detailed records to 
demonstrate compliance with the organic production rules , in particular with respect to 
any external product and substance used in the wine production and for cleaning and 
disinfection.  
(24) Without prejudice to the record -keeping requ irements under Regulation (EC) No 
852/2004, operators producing organic y east should  keep detailed records to 
demonstrate compliance with the organic production rules , in particular with respect to 
the products and substances used in the yeast production a nd for cleaning and 
disinfection.  
(25) Annex II to Regulation (EU) 2018/848 should therefore be amended accordingly.  
(26) In the interest of clarity and legal certainty, this Regulation should apply from the date 
of application of Regulation (EU) 2018/848,   
EN 6  EN HAS ADOPT ED THIS REGULATION:  
Article 1  
Annex II to Regulation (EU) 2018/848 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 January 2022 . 
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