Commission Delegated Regulation (EU) 2021/1698 of 13 July 2021 supplementing Regulation (EU) 2018/848 of the European Parliament and of the Council 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 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 (Text with EEA relevance)

CHAPTER I

PROCEDURAL REQUIREMENTS FOR THE RECOGNITION OF CONTROL AUTHORITIES AND CONTROL BODIES

Article 1

Requirements referred to in point (n) of Article 46(2) of Regulation (EU) 2018/848

The technical dossier referred to in Article 46(4) of Regulation (EU) 2018/848 shall contain the following information in one of the official languages of the Union:

(a) the following information about the control authority or control body: (i) name; (ii) mailing address; (iii) telephone number; (iv) email contact point; (v) for control bodies, the name of their accreditation body;

(b) an overview of the intended activities of the control authority or control body in the third country or third countries concerned, including an indication of the organic products, together with their Combined Nomenclature (CN) codes according to Council Regulation (EEC) No 2658/87 (¹), distributed per category of products as set out in Article 35(7) of Regulation (EU) 2018/848, that are intended to be imported into the Union in accordance with point (b)(i) of Article 45(1) of Regulation (EU) 2018/848 during the first year of activity following the recognition by the Commission;

(c) a description of the control authority or control body as regards: (i) its structure and size; (ii) its IT management system; (iii) its branch offices, if any; (iv) its type of activities, including delegated activities, if any; (v) its organisational chart; (vi) its quality management;

(d) the certification procedures, in particular for granting or rejecting, suspension or withdrawal of the certificate referred to in point (b)(i) of Article 45(1) of Regulation (EU) 2018/848;

(e) the translation of the production rules and control measures set out in Regulation (EU) 2018/848, and the delegated and implementing acts adopted pursuant to it in languages that are understandable for the contracted operators in the third countries for which the control authority or control body requests recognition;

(f) the documents proving that the criteria set out in Article 46(2) of Regulation (EU) 2018/848 are fulfilled, in particular a copy of the accreditation certificate granted by the accreditation body covering all categories of products for which recognition is requested;

(g) the procedures describing in detail the functioning and the implementation of the control measures to be set up in accordance with this Regulation, including, where relevant, control specificities for the group of operators;

(h) a catalogue of measures to be taken in cases of established non-compliance as laid down in Article 22 of this Regulation;

(i) 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: (i) that the control authority or control body has been satisfactorily assessed on its ability to ensure that products imported from third countries meet the conditions set out in points (a), (b)(i) and (c) of Article 45(1) and in Article 46(2) of Regulation (EU) 2018/848; (ii) that the control authority or control body has the capacity and the competencies to implement effectively the control requirements and fulfil the criteria set out in Article 46(2) of Regulation (EU) 2018/848 and in this Regulation in each third country for which it requests recognition;

(j) proof that the control authority or control body has notified its activities to the relevant authorities of the third country concerned and its undertaking to respect the legal requirements imposed on it by the authorities of the third country concerned;

(k) a website address, with a content available in at least one of the official languages of the Union and also understandable for the contracted operators, where the list referred to in point (a) of Article 17 of this Regulation can be found;

(l) an undertaking by the control authority or control body to give access to all its offices and facilities to independent experts designated by the Commission and keep available and communicate all information related to its control activities in the third country concerned;

(m) a statement by the control authority or control body that it has not been subject to withdrawal by the Commission, or withdrawn or suspended by any accreditation body, in the 24 months preceding their request for recognition for the third country and/or category of products they request a recognition for. This requirement does not apply in case of withdrawal pursuant to point (k) of Article 46(2a) of Regulation (EU) 2018/848;

(n) any other information deemed relevant by the control authority or control body, or by the accreditation body.

Article 2

Extension of the scope of the recognition

A control authority or control body recognised in accordance with Article 46 of Regulation (EU) 2018/848 may submit a request for extension of the scope of its recognition to an additional third country or to an additional category of products using the model made available by the Commission.

The request for extension of the scope of recognition shall consist of an update of the relevant parts of the technical dossier referred to in Article 1(2) with the appropriate information on the additional third country or the additional category of products subject to the scope extension.

CHAPTER II

SUPERVISION OF THE CONTROL AUTHORITIES AND CONTROL BODIES BY THE COMMISSION

Article 3

General requirements for the supervision of control authorities and control bodies

Control authorities and control bodies recognised in accordance with Article 46(1) of Regulation (EU) 2018/848 shall maintain the ability to meet the conditions and criteria set out in points (a), (b)(i) and (c) of Article 45(1) and Article 46(2) of that Regulation as set out in the technical dossier at the moment of their recognition. They shall also maintain the capacity and competencies to implement the control requirements, conditions and measures set out in Article 46(2) and (6) of Regulation (EU) 2018/848 and in this Regulation.

For that purpose, they shall demonstrate:

(a) that they have effectively implemented their activities according to the conditions and criteria referred to in the first subparagraph; and

(b) compliance with their operating procedures and the effectiveness of their control measures.

For the purpose of the annual report, the control bodies shall ensure that witness audits are carried out in accordance with Sections 1 and 2 of Part B of Annex I to this Regulation and the following rules:

(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;

(b) the number of witness audits carried out for the initial request for recognition shall not be considered for the calculation of the total number of witness audits to be carried out during the 4 years referred to in point (a);

(c) one additional witness audit shall be carried out: (i) every 2 years in those third countries where the high-risk product as referred to in Article 8 is produced or processed; (ii) for every 10 third countries recognised. This additional witness audit shall be carried out within 4 years;

(d) more witness audits shall be performed at the request of the Commission or of the accreditation body based on a risk analysis of, in particular, the following factors: (i) the number of inspectors; (ii) the number of operators; (iii) the type of activities carried out by the operators; (iv) the number of witness audits carried out by the accreditation body; (v) the irregularities concerning the control bodies; (vi) the number of certified groups of operators and the size of them; (vii) the critical findings for the control bodies or the specific inspector or inspectors; (viii) the nature of the products and the risk of fraud; (ix) Commission feedback based on the previous annual report of the control body; (x) suspicions of fraud by operators. (xi) the volume of products imported from a third country into the Union and the activity of the control authority or control body in recognised third countries.

Article 4

Annual report

By 28 February every year, the control authority or control body shall submit an annual report to the Commission.

That annual report shall set out the activities of the control authority or control body in the previous year in accordance with Annex II

It shall be submitted in one of the official languages of the Union and in English if the official language chosen is not English.

Article 5

On–the-spot examinations and audits

On-the-spot examinations and audits may include:

(a) a visit to the offices or premises of the control authorities and control bodies, their outsourced services and operators or groups of operators under their control, in the Union and in third countries;

(b) a document review of the relevant documents describing the structure, functioning and quality management of the control authorities or control bodies;

(c) a document review of staff files, including evidence of their competencies, training records, conflict of interest statements and records of evaluation and supervision of staff;

(d) a check of operators’ or groups of operators’ files in order to verify the treatment of non-compliances and complaints, the minimum control frequency, the use of a risk-based approach in the conduct of inspections, the implementation of follow-up visits and visits without prior notice, the sampling policy and the exchange of information with other control bodies and control authorities;

(e) a review audit, which is the inspection of operators or groups of operators to verify compliance with the standard control and risk assessment procedures of the control authority or control body and to verify its effectiveness, taking into account the evolution of the operators’ situation from the last inspection of the control authority or control body;

(f) a witness audit, which is the evaluation of the performance of the physical on-the-spot inspection carried out by an inspector of the control authority or control body.

Article 6

Traceability checks

The Commission may perform traceability checks on products or consignments covered by the scope of the recognition of a control authority or control body recognised in accordance with Article 46(1) of Regulation (EU) 2018/848.

For the purpose of tracing the ingredients or production phases of an organic product, the Commission may ask information from the competent authorities or from control authorities or control bodies involved in the control of those products falling under their supervision.

The Commission may perform traceability checks based on the annual risk assessment performed by it, complaints received by the Commission or Member States, or randomly.

The Commission shall perform traceability checks in a timeframe defined by it, which shall be communicated in time to the relevant competent authorities, control authorities and control bodies involved.

Article 7

Ad hoc request by the Commission

The Commission may, at any time, based on a substantial analysis proving the necessity, make ad-hoc requests for information to a control authority or control body.

Article 8

List of high-risk third countries and high-risk products

High-risk products and the third countries in which they originate shall be listed together with the shares of consignments of those products to be subject to identity and physical checks and sampling by control authorities and control bodies in third countries, in an implementing act adopted in accordance with Article 46(8) of Regulation (EU) 2018/848 on the basis of a selection made after major, critical or repetitive non-compliances affecting the integrity of organic or in-conversion products or production, or the suspicion thereof.

The shares referred to in the first paragraph can be lower than 100 % and may, for the same product, be different for controls by control authorities and control bodies in third countries.

CHAPTER III

CONTROLS IN RESPECT OF OPERATORS AND GROUPS OF OPERATORS BY THE CONTROL AUTHORITIES AND CONTROL BODIES

Article 9

General provisions

Controls performed by control authorities and control bodies for the verification of compliance with Regulation (EU) 2018/848 by operators and groups of operators in third countries shall include:

(a) the verification of the application of preventive and precautionary measures, as referred to in Article 9(6) and in Article 28 of Regulation (EU) 2018/848, at every stage of production, preparation and distribution;

(b) where the holding includes non-organic or in-conversion production units, the verification of the records and of the measures or procedures or arrangements in place to ensure the clear and effective separation between organic, in- conversion and non-organic production units as well as between the respective products produced by those units, and of the substances and products used for organic, in-conversion and non-organic production units. Such verification shall include checks on parcels for which a previous period was recognised retroactively as part of the conversion period, and checks on the non-organic production units;

(c) where organic, in-conversion and non-organic products are collected simultaneously by operators, are prepared or stored in the same preparation unit, area or premises, or are transported to other operators or units, the verification of the records and of the measures, procedures or arrangements in place to ensure that operations are carried out separated by place or time, that suitable cleaning measures and measures to prevent substitution of products are implemented, that organic products and in-conversion products are identified at all times, that organic, in-conversion and non-organic products are stored, before and after the preparation operations, separated by place or time from each other, and that traceability of each lot from the individual land parcels to the collection centre has been ensured.

Controls by control authorities and control bodies for the verification of compliance with Regulation (EU) 2018/848 shall be performed on all operators and groups of operators in third countries regularly, on a risk basis and with appropriate frequency, throughout the entire process at all stages of production, preparation and distribution on the basis of the likelihood of non-compliance as defined in point (57) of Article 3 of Regulation (EU) 2018/848, which shall be determined taking into account the following elements:

(a) the type, size, including newly added land parcels, and structure of the operators and groups of operators, as well as the number of new members joining the group of operators;

(b) location and complexity of the activities or operations of operators and groups of operators;

(c) the length of time during which operators and groups of operators have been involved in organic production, preparation and distribution;

(d) the results of the controls performed in accordance with this Article, in particular as regards compliance with Regulation (EU) 2018/848;

(e) in the case of a group of operators, the results of the internal inspections carried out in accordance with the documented procedures of the system for internal controls of the group of operators;

(f) whether the holding includes non-organic or in-conversion production units;

(g) the type, quantity and value of products;

(h) the risk of commingling of products or contamination with non-authorised products or substances;

(i) the application of derogations or exceptions to the rules by operators and groups of operators;

(j) the critical points for non-compliance at every stage of production, preparation and distribution;

(k) subcontracting activities;

(l) whether operators or groups of operators have changed their certifying control authority or control body;

(m) any information indicating the likelihood that consumers might be misled;

(n) any information that might indicate non-compliance with Regulation (EU) 2018/848.

For the high-risk products referred to in Article 8, the control authority or control body shall carry out, at least, two physical on-the-spot inspections per year of operators or groups of operators. One of these physical on-the-spot inspections shall be without prior notice.

Article 10

Checks for the certification of operators or groups of operators

Before accepting to certify operators or groups of operators, a control authority or control body shall ensure that the operators or groups of operators have provided the following:

(a) a document in the form of a signed declaration, setting out: (i) a description of the organic and/or in-conversion production unit and, where relevant, of the non-organic production units and of the activities to be performed in accordance with Regulation (EU) 2018/848; (ii) the relevant measures to be taken at the level of the organic and/or in-conversion unit and/or premises and/or activities to ensure compliance with Regulation (EU) 2018/848; (iii) the precautionary measures to be taken in order to reduce the risk of contamination by non-authorised products or substances and the cleaning measures to be taken throughout the stages of production, preparation and distribution;

(b) a confirmation that the operators or groups of operators have not been certified by another control body in relation to activities carried out in the same third country regarding the same category of products, including in cases in which operators or groups of operators operate at different stages of production, preparation or distribution;

(c) a confirmation by the members of a group of operators that they have not been certified on an individual basis for the same activity for a given product covered by the certification of the group of operators to which they belong;