the following information about the control authority or control body:

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;

a description of the control authority or control body as regards:

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;

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;

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;

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;

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

►M1  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: ◄

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;

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;

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;

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;

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

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

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

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;

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);

one additional witness audit shall be carried out:

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:

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;

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

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;

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;

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;

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.

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;

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;

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.

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;

location and complexity of the activities or operations of operators and groups of operators;

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

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

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;

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

the type, quantity and value of products;

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

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

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

subcontracting activities;

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

any information indicating the likelihood that consumers might be misled;

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

a document in the form of a signed declaration, setting out:

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;

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;

a signed undertaking by which the operators or groups of operators commit themselves:

that the operators or groups of operators comply with Chapters II, III and IV of Regulation (EU) 2018/848 and Article 36 of that Regulation. The verification shall include at least one physical on-the-spot inspection;

that, where the operators or groups of operators subcontract any of its activities to third parties, both the operators or groups of operators and the third parties to whom those activities have been subcontracted, have been certified by recognised control authorities or control bodies confirming that they comply with Chapters II, III and IV of Regulation (EU) 2018/848 and Article 36 of that Regulation, unless the operators or groups of operators inform the relevant control authority or control body that they remain responsible as regards organic production and that they have not transferred that responsibility to the subcontractor. In such cases, the control authority or control body shall verify that the subcontracted activities comply with Chapters II, III and IV of Regulation (EU) 2018/848 and Article 36 of that Regulation in the context of the control activities it carries out in respect of the operators or groups of operators that have subcontracted their activities.

the status and validity of certification, including cases of scope reduction, suspension and withdrawal as referred to in International Organisation for Standardisation (ISO) standard ISO/IEC 17065;

reports of inspection carried out in the preceding 3 years;

the list of non-compliances and the measures put in place to address them, and the fact that all non-compliances were addressed;

derogations granted or requests for derogation being processed by the previous control authority or control body;

information relating to any ongoing dispute relevant for the certification of the operators or groups of operators.

a check whether the maps or sketches with cardinal directions and geo-location of the production units and premises to be physically inspected, as provided by the operators or groups of operators, is up-to-date;

an inspection of, as appropriate:

an examination of documents, traceability records and other records and practices and procedures that are relevant for the assessment of compliance with Regulation (EU) 2018/848. This includes documents accompanying food, feed and any substance or material entering or leaving an establishment;

interviews with operators and their staff;

sampling and laboratory analysis;

the examination of the control system that operators and groups of operators have put in place, including an evaluation of its effectiveness;

the examination of non-compliances found during previous inspections and the measures taken by the operators or by the groups of operators to address them;

any other action required to identify cases of non-compliance.

the name and address of the supplier and, where different, of the owner or the seller, or the exporter of the products;

the name and address of the consignee and, where different, of the buyer or importer of the products;

the certificate of the supplier in accordance with an implementing act adopted pursuant Article 45(4) of Regulation (EU) 2018/848;

the information referred to in the first paragraph of point 2.1 of Annex III to Regulation (EU) 2018/848;

the appropriate lot identification;

in the case of processors, the necessary information to allow internal traceability and guarantee the organic status of ingredients.

the nature and the quantities of products delivered to the unit and, where relevant, of materials bought and the use of such materials, and, where relevant, the composition of products;

the nature and the quantities of products held in storage at the premises including at the time of the physical on-the-spot inspection;

the nature and quantities of the products that have left the unit of the operators or groups of operators to the consignee’s premises or storage facilities;

in case of operators or groups of operators who buy or sell the product(s) without storing or physically handling the product(s), the nature and the quantities of products that have been bought and sold;

the yield of the products obtained, collected or harvested over the previous year;

the estimated or actual yield of the products obtained, collected or harvested over the current year;

the number and/or weight of livestock managed over the current and previous year;

any losses, increase or decrease in quantity of products at any stage of production, preparation and distribution;

the total output of the holding in terms of organic and non-organic products.

they are accredited laboratories that meet the applicable requirements of ISO standard ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’;

their accreditation bodies are signatory of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement;

they have sufficient capacity for analysis and testing and they can ensure that samples are always tested with relevant methods included in the scope of their accreditation;

as regards residue pesticide testing, they are accredited for gas and liquid spectrometry in order to be able to cover the list of pesticide residues monitored under the coordinated multi-annual control programme of the Union set out in Commission Implementing Regulation (EU) 2019/533 ( 4 ).

a statement on the objectives to be achieved;

tasks, responsibilities and duties of staff;

sampling strategy, procedures and methodology, control methods and techniques, including laboratory analysis, testing and interpretation and evaluation of results and consequent decisions;

cooperation and communication with other control authorities, other control bodies and the Commission;

a procedure for assessing the risk linked to operators or groups of operators and for carrying out physical on-the-spot inspections and sampling;

verification of the appropriateness of methods of sampling and of laboratory analysis, testing and diagnosis;

any other activity or information required for the effective functioning of the controls, including in relation to training of inspectors and evaluation of their competencies;

for groups of operators, the effectiveness of the system for internal controls.

take corrective measures in all cases where the procedures provided for in paragraph 1 identify shortcomings; and

update the documented procedures provided for in paragraph 1 as appropriate.

a description of the purpose of the controls;

the control methods and techniques applied;

the outcome of the controls, in particular the results of verifying the elements listed in Articles 11 and 12 of this Regulation; and

actions that the operator or group of operators concerned is required to take as a result of the controls carried out by the control authority or control body, with an indication of the deadline to take action.

the control authority or control body of the producer or the processor of the product concerned; or

where the operator or group of operators carrying out the last operation for the purpose of preparation is different from the producer or processor of the product, the control authority or control body of the operator or group of operators carrying out the last operation for the purpose of preparation as defined in point (44) of Article 3 of Regulation (EU) 2018/848.

the traceability of the products and ingredients;

that the volume of the products included in the consignment is in line with the mass balance checks of the respective operators or groups of operators according to the assessment carried out by the control authority or control body;

the relevant transport documents and commercial documents (including invoices) of the products;

in case of processed products, that all organic ingredients of such products have been produced by operators or groups of operators certified in a third country by a control authority or control body recognised in accordance with Article 46(1) or referred to in Article 57 of Regulation (EU) 2018/848 or by a third country recognised in accordance with Articles 47 and 48 of Regulation (EU) 2018/848, or have been produced and certified in the Union in accordance with that Regulation.

the relevant criteria listed in Article 9(2);

whether there are several operators involved in the distribution chain of the products who do not store or physically handle organic products;

high-risk products referred to in Article 8;

any criteria deemed relevant by the control authority or control body.

it shall immediately carry out an investigation with a view to verifying compliance with Regulation (EU) 2018/848 or with the delegated or implementing acts adopted pursuant to that Regulation; such investigation shall be completed as soon as possible, within a reasonable period, and shall take into account the durability of the product and the complexity of the case;

it shall prohibit the import from that third country for the purpose of placing the product concerned on the market within the Union as organic or in-conversion product pending the results of the investigation referred to in point (a). Before taking such a provisional decision, the control authority or control body, shall give the operator or group of operators an opportunity to comment.

a list of non-compliances with reference to the specific rules of Regulation (EU) 2018/848 or of the delegated or implementing acts adopted pursuant to that Regulation. That list shall include, at least the non-compliances listed in Part B of Annex IV to this Regulation;

the classification of the non-compliances into three categories: minor, major and critical as set out in Part A of Annex IV to this Regulation, taking into account at least the following criteria:

the measures to be applied for each non-compliance.

take any action necessary to determine the origin and extent of the non-compliance and to establish the responsibilities of the operator or group of operators; and

take appropriate measures to ensure that the operator or group of operators remedies the non-compliance and prevents further occurrences of such non-compliance.

applying the catalogue of measures referred to in Article 22(3) of this Regulation;

ensuring that the operator or group of operators increases the frequency of own controls;

ensuring that certain activities of the operator or of the group of operators are subject to increased or systematic controls by the control authority or control body.

maps identifying clearly each land parcel covered by the request for retroactive recognition and information on the total surface of those land parcels and, if relevant, on the nature and the volume of the ongoing production and their geolocation coordinates;

any other relevant documents deemed necessary by the control authority or control body to assess the request for retroactive recognition.

it shall carry out a detailed risk analysis based on documentary evidence to assess whether any land parcel covered by the request for retroactive recognition has been treated with products or substances that are not authorised for use in organic production for a period of at least 3 years, taking into account in particular the size of the total surface to which the request relates and the agronomic practices carried out during that period on each land parcel subject to the request. The control authority or control body shall keep documents on the risk analysis;

it shall take samples on soil and/or plant from each land parcel in line with the results of the risk analysis referred to in point (a), including those land parcels identified as presenting the risk of being contaminated;

it shall draw up an inspection report in one of the official languages of the Union, including photographs of the parcels, following a physical inspection of the operator, including the land parcels covered by the request for retroactive recognition for the purpose of verifying the consistency of the information collected, but before any cultivation measures have been taken by the operator.

scientific and common name (common and Latin name);

variety;

total weight of seeds or number of plants concerned;

the availability of organic or in-conversion plant reproductive material;

documentation or a statement from the operator proving that the requirements set out in point 1.8.5.2 of Part I of Annex II to Regulation (EU) 2018/848 have been fulfilled.

scientific and common name (common and Latin name, i.e. species and genus);

breeds and strains;

production purposes: meat, milk, eggs, dual purpose or breeding;

total number of animals;

availability of the relevant organic livestock species;

documentation or a statement from the operator proving that the requirements set out in point 1.3.4.3 and 1.3.4.4 of Part II of Annex II to Regulation (EU) 2018/848 have been fulfilled.

species and genus (common and Latin name);

breeds and strains when applicable;

life stage (such as eggs, fry, juveniles) as available for sale as organic;

quantity available as estimated by the operator;

total number of juveniles;

availability of the relevant organic aquaculture species;

documentation or a statement from the operator proving that the requirements set out in point 3.1.2.1 of Part III of Annex II to Regulation (EU) 2018/848 have been fulfilled.

for a limited period and no longer than necessary, and in no case longer than 12 months, to continue or recommence organic production as carried out before the date of application of those derogations;

in relation to specifically affected types of production or, where relevant, land parcels; and

to the individual operator or the member of the group of operators concerned.

point 1.7.2 and the first paragraph of point 1.7.3 of Part I;

points 1.3.4.3, 1.3.4.4.3, 1.6.7, 1.7.5, 1.7.8, 1.9.3.1, 1.9.4.1 and 1.9.4.2 of Part II;

points 3.1.2.1 and 3.1.3.1 of Part III.