COMMISSION DELEGATED REGULATION (EU) …/... amending Delegated Regulation (EU) 2021/1698 as regards certain procedural requirements for the recognition of control authorities and control bodies that are competent to carry out controls on operators and groups of operators certified organic and on organic products in third countries and certain requirements on their supervision
Date: 2023-05-17
Institutions: Directorate-General for Agriculture and Rural Development, European Commission
Subjects: common agricultural policy, rural development



IMMC.Ares%282023%293453246.ENG.xhtml.PART-2023-301010V2.docx








EXPLANATORY MEMORANDUM


1.CONTEXT OF THE DELEGATED ACT


Regulation (EU) 2018/848 of the European Parliament and of the Council
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 sets general and detailed rules for the Commission to recognise control authorities and control bodies that are competent to carry out controls on organic products to be exported from third countries to the Union and to issue organic certificates in third countries. That act is supplemented by Delegated Regulation (EU) 2021/1698
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 as regards, inter alia, certain procedural requirements for the recognition of those control authorities and control bodies and with rules on their supervision. 


These rules and procedural requirements came into force on 1 January 2022. This was three years ahead of the expiry, on 31 December 2024, of the regime under which control authorities and control bodies currently operate, namely the regime established under Council Regulation (EC) 834/2007
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 (equivalence regime). However, national measures in third countries due to the COVID-19 pandemic had a negative impact on the ability of the accreditation bodies, which accredit control bodies for the purposes of import of compliant organic products into the Union
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, to schedule and carry out witness audits for the purpose of the submission by control authorities and control bodies of requests for recognition under the new regime introduced by Regulation (EU) 2018/848 (compliance regime). To ensure a smooth transition between the two regimes and to avoid risks of trade disruptions, it is necessary to derogate temporarily from the rule set out in Article 1(2)(i) and in point 3(a) of Part B of Annex I to Commission Delegated Regulation (EU) 2021/1698, by extending the period within which witness audits may be carried out preceding their submission by control authorities and control bodies when applying for recognition under the compliance regime.


Control authorities and control bodies can start operating under the compliance regime only once they are recognised by the Commission. Whilst their recognition will, therefore, be based on criteria assessing their readiness to operate, for the Commission to carry out the required supervisory activities, witness audits need to be based on the performance of control authorities and control bodies under the compliance regime. To this end, it is necessary to set out a timeframe within which control authorities and control bodies must notify the Commission that they have updated the technical dossier used for their recognition with new witness audit reports on new witness audits carried out based on their performance under the compliance regime. Lastly, it is necessary to clarify the date at which the four years duration period between witness audits, as established in Delegated Regulation (EU) 2021/1698, starts for the first time.


2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT


The act was discussed thoroughly with the Group of Experts on Organic Production as well as with the main organisations representing accreditation and control authorities and control bodies active in the import of organic products from third countries. [A public consultation was carried out] and DG AGRI cooperated closely with other DGs in the field of their specific expertise when drafting these rules.


3.LEGAL ELEMENTS OF THE DELEGATED ACT


This act modifies Delegated Regulation (EU) 2021/1698 as regards the period within which witness audits may be carried out preceding their submission by control authorities and control bodies when applying for recognition under the compliance regime.


This act also lays down additional provisions relating to the timing, following their recognition, within which control authorities and control bodies must provide new witness audit reports on new witness audits based on their performance under the compliance regime.


COMMISSION DELEGATED REGULATION (EU) …/...


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amending Delegated Regulation (EU) 2021/1698 as regards certain procedural requirements for the recognition of control authorities and control bodies that are competent to carry out controls on operators and groups of operators certified organic and on organic products in third countries and certain requirements on their supervision


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 834/2007
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, and in particular Article 46(7) thereof, 


Whereas:


(1)Commission Delegated Regulation (EU) 2021/1698
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 supplements Regulation (EU) 2018/848 with procedural requirements for the recognition of control authorities and control bodies that are competent to carry out controls on operators and groups of operators certified as organic and on organic products in third countries and with rules on their supervision and the controls and other actions to be performed by those control authorities and control bodies.


(2)A request by control authorities and control bodies for recognition in accordance with Article 46(1) of Regulation (EU) 2018/848 (compliance regime) consists of a technical dossier. Pursuant to Article 1(2), point (i), of Delegated Regulation (EU) 2021/1698, that technical dossier must contain, among other things, a copy of the most recent assessment report drawn up by the accreditation body or, as appropriate, by the competent authority, including a witness audit report on a witness audit carried out within two years preceding the submission of the request for recognition.




(3)Pursuant to Article 57(1) of Regulation (EU) 2018/848, the recognition of control authorities and control bodies granted under Article 33(3) of Council Regulation (EC) No 834/2007
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 (equivalence regime) will expire on 31 December 2024. Pursuant to point 3(a) of Part B of Annex I to Delegated Regulation (EU) 2021/1698, for those control authorities or control bodies, the witness audit reports to be submitted with their request for recognition under the compliance regime must result from witness audits carried out during the two years preceding the submission of the request for recognition, by the accreditation body or competent authority for the purpose of their recognition under Regulation (EC) No 834/2007. 


(4)National measures in third countries taken due to the COVID-19 pandemic had a negative impact on the ability of accreditation bodies and competent authorities to schedule and carry out witness audits for the purpose of recognition by control authorities and control bodies under the compliance regime. To ensure a smooth transition from the equivalence regime to the compliance regime and to avoid risks of trade disruptions, for requests for recognition submitted before the expiration of the transition period provided for in Article 57(1) of Regulation (EU) 2018/848, the validity period of the witness audits referred to in Article 1(2), point (i) and in Point 3(a) of Part B of Annex I to Delegated Regulation (EU) 2021/1698 should be extended.


(5)For the Commission to be able to carry out effectively its supervisory activities pursuant to Delegated Regulation (EU) 2021/1698, control authorities and control bodies recognised in accordance with Article 46(1) of Regulation (EU) 2018/848 need to operate and be assessed by accreditation bodies or competent authorities based on their performance under the compliance regime. Therefore, it should be ensured that, within 2 years of the initial recognition of control authorities and control bodies in accordance with Article 46(1) of Regulation (EU) 2018/848 or of the extension of the scope of recognition to an additional category of products in accordance with Article 2 of Delegated Regulation (EU) 2021/1698, the control authorities and control bodies should submit to the Commission a new witness audit report on a new witness audit carried out for each of the categories of products for which they have been recognised. Furthermore, the procedure for submitting those new witness audit reports should be specified.


(6)For the purpose of clarifying the beginning of the period between two witness audits referred to in Article 3(4), point (a), of Delegated Regulation (EU) 2021/1698, the first four-year period should start at the date when the first witness audits after recognition, or for the extension of the scope of recognition to an additional category of products, were carried out.         


(7)Commission Delegated Regulation (EU) 2021/1698 should be amended accordingly,


HAS ADOPTED THIS REGULATION:


Article 1


Delegated Regulation (EU) 2021/1698 is amended as follows:


(1)in Article 1(2), point (i), the introductory wording is replaced by the following:


‘a copy of the most recent assessment report referred to in Article 46(4), second subparagraph, of Regulation (EU) 2018/848, drawn up by the accreditation body or, as appropriate, by the competent authority, containing the information referred to in Part A of Annex I to this Regulation, including a witness audit report on a witness audit carried out within 2 years preceding the submission of the request for recognition. By way of derogation, for requests for recognition submitted before 31 December 2024, the witness audit report may be on a witness audit carried out within 3 years preceding the submission of the request for recognition. The assessment report shall give the following guarantees:’; 


(2)Article 3 is amended as follows: 


(a)a new paragraph 3a is inserted:


‘3a. Within 2 years from the initial recognition or from the extension of the scope of recognition to a new category of products in accordance with Article 2, the control authority or control body shall provide a new witness audit report on a new witness audit carried out in accordance with Sections 1 and 2 of Part B of Annex I for the categories of products for which it has been recognised or for which the scope of recognition was extended.’; 


(b)in paragraph 4, point (a) is replaced by the following:


‘(a) the period between two witness audits shall not exceed 4 years, starting from the date of the first witness audit carried out after the initial recognition or the initial extension of scope to a new category of products’;


(3)in Article 19, paragraph 1 is replaced by the following:


‘1. After its recognition, the control authority or control body shall notify the Commission in due time, and not later than within 30 calendar days, of the occurrence of changes to the content of its technical dossier, including the new witness audit reports referred to in Article 3(3a).’;


(4)in Part B of Annex I, point 3(a) is replaced by the following:


‘(a) during the last 3 years by their accreditation body or competent authority for the purpose of their recognition under Regulation (EC) No 834/2007 for each category of products for which the control authority or control body requests recognition in accordance with Article 46 of regulation (EU) 2018/848; and’


Article 2




This Regulation shall enter into force on the third 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