(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 Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1 ).(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.
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)
Modified by
- Commission Delegated Regulation (EU) 2023/1686of 30 June 2023amending 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, 32023R1686, September 5, 2023
(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.
(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.
(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.
(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.
(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.
(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; (d) a signed undertaking by which the operators or groups of operators commit themselves: (i) to give the control authority or control body access to all parts of all production units and all premises for control purposes, as well as to the accounts and relevant supporting documents; (ii) to provide the control authority or control body with any information necessary for the purposes of the controls; (iii) to submit, when requested by the control authority or control body, the results of its own quality assurance programmes; (iv) to inform buyers of the products in writing and without undue delay, and to exchange relevant information with the control authority or control body, in the event that a suspicion of non-compliance has been substantiated, that a suspicion of non-compliance cannot be eliminated, or that non-compliance that affects the integrity of the products in question has been established; (v) to accept the transfer of the control file in case of a change of control authority or control body or, in the case of withdrawal from organic production, the keeping of the control file for 5 years by the last control authority or control body; (vi) to inform immediately the control authority or control body in the event of withdrawal from organic production; (vii) in the event that the subcontractors of the operators or of groups of operators are subject to controls by different control authorities or control bodies, to accept the exchange of information among those control authorities or control bodies; (viii) to perform the activities in accordance with the organic production rules; (ix) to accept the enforcement of the corrective measures established by the control authority or control body in the event of non-compliances.
(a) 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; (b) 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.
(a) 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; (b) reports of inspection carried out in the preceding 3 years; (c) the list of non-compliances and the measures put in place to address them, and the fact that all non-compliances were addressed; (d) derogations granted or requests for derogation being processed by the previous control authority or control body; (e) information relating to any ongoing dispute relevant for the certification of the operators or groups of operators.
(a) 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; (b) an inspection of, as appropriate: (i) the production units, equipment, means of transport, premises and other places under the control of the operator or group of operators; (ii) animals, plants and goods, including semi-finished goods, raw materials, ingredients, processing aids and other products used for the preparation and production of goods or for feeding or treating animals, and substances authorised for use in organic production; (iii) traceability, labelling, presentation, advertising and relevant packaging materials;
(c) 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; (d) interviews with operators and their staff; (e) sampling and laboratory analysis; (f) the examination of the control system that operators and groups of operators have put in place, including an evaluation of its effectiveness; (g) 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; (h) any other action required to identify cases of non-compliance.
(a) the name and address of the supplier and, where different, of the owner or the seller, or the exporter of the products; (b) the name and address of the consignee and, where different, of the buyer or importer of the products; (c) the certificate of the supplier in accordance with an implementing act adopted pursuant Article 45(4) of Regulation (EU) 2018/848; (d) the information referred to in the first paragraph of point 2.1 of Annex III to Regulation (EU) 2018/848; (e) the appropriate lot identification; (f) in the case of processors, the necessary information to allow internal traceability and guarantee the organic status of ingredients.
(a) 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; (b) the nature and the quantities of products held in storage at the premises including at the time of the physical on-the-spot inspection; (c) 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; (d) 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; (e) the yield of the products obtained, collected or harvested over the previous year; (f) the estimated or actual yield of the products obtained, collected or harvested over the current year; (g) the number and/or weight of livestock managed over the current and previous year; (h) any losses, increase or decrease in quantity of products at any stage of production, preparation and distribution; (i) the total output of the holding in terms of organic and non-organic products.
(a) 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"; (b) their accreditation bodies are signatory of the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement; (c) 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; (d) 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 Commission Implementing Regulation (EU) 2019/533 of 28 March 2019 concerning a coordinated multiannual control programme of the Union for 2020, 2021 and 2022 to ensure compliance with maximum residue levels of pesticides and to assess the consumer exposure to pesticide residues in and on food of plant and animal origin (OJ L 88, 29.3.2019, p. 28 ).
(a) a statement on the objectives to be achieved; (b) tasks, responsibilities and duties of staff; (c) sampling strategy, procedures and methodology, control methods and techniques, including laboratory analysis, testing and interpretation and evaluation of results and consequent decisions; (d) cooperation and communication with other control authorities, other control bodies and the Commission; (e) a procedure for assessing the risk linked to operators or groups of operators and for carrying out physical on-the-spot inspections and sampling; (f) verification of the appropriateness of methods of sampling and of laboratory analysis, testing and diagnosis; (g) 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; (h) for groups of operators, the effectiveness of the system for internal controls.
(a) take corrective measures in all cases where the procedures provided for in paragraph 1 identify shortcomings; and (b) update the documented procedures provided for in paragraph 1 as appropriate.
(a) a description of the purpose of the controls; (b) the control methods and techniques applied; (c) the outcome of the controls, in particular the results of verifying the elements listed in Articles 11 and 12 of this Regulation; and (d) 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.
(a) the control authority or control body of the producer or the processor of the product concerned; or (b) 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.
(a) the traceability of the products and ingredients; (b) 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; (c) the relevant transport documents and commercial documents (including invoices) of the products; (d) 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.
(a) the relevant criteria listed in Article 9(2); (b) whether there are several operators involved in the distribution chain of the products who do not store or physically handle organic products; (c) high-risk products referred to in Article 8; (d) any criteria deemed relevant by the control authority or control body.
(a) a list of certified operators and certified groups of operators, containing: (i) for operators, their name and address; (ii) for groups of operators, the name and address of the group and the number of its members; (iii) information relating to the certificates, in particular, the certificate number, category of products covered by the certification, status and validity of certification, including cases of scope reduction, suspension and withdrawal as referred to in ISO standard ISO/IEC 17065;
(b) in the case of control bodies, updated information on their accreditation, including a link to the latest accreditation certificate issued by its accreditation body.
(a) name and address of the operators or groups of operators. In case of a group of operators, the size of the group, name and address of each member of the group; (b) information concerning the scope of the certification, certificate number, status and validity of the certificate; (c) status of the operators or groups of operators, whether in conversion (including period of conversion) or organic; (d) risk level of the operators or groups of operators in accordance with Article 9; (e) in case of subcontracting activities that are under the control of the certified operators or groups of operators, name and address of the subcontracted third party or third parties; (f) the geographical coordinates and surface area of all the production units and premises; (g) inspection reports and the results of sampling analysis, as well as the results of any other controls performed, including the controls carried out on consignments; (h) non-compliances and measures applied; (i) notifications via the system referred to in Article 20(1); (j) derogations granted and relevant supporting documents in accordance with the requirements of this Regulation; and (k) any other information deemed relevant by the control body or the control authority.
(a) 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; (b) 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) 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; (b) 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: (i) the application of precautionary measures referred to in Article 28(1) of Regulation (EU) 2018/848, the practical measures referred in point (a)(ii) of Article 10(1) of this Regulation and the reliability of own controls carried out by the operator or group of operators in line with point (f) of Article 11(1) of this Regulation; (ii) the impact on the integrity of the organic or in-conversion of products; (iii) the ability of the traceability system to locate the affected product(s) in the supply chain and prohibition of importing from a third country for the purpose of placing the product(s) on the market within the Union with reference to organic production; (iv) the response of the operator or group of operators to previous requests from the control authority or control body;
(c) the measures to be applied for each non-compliance.
(a) 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 (b) take appropriate measures to ensure that the operator or group of operators remedies the non-compliance and prevents further occurrences of such non-compliance.
(a) applying the catalogue of measures referred to in Article 22(3) of this Regulation; (b) ensuring that the operator or group of operators increases the frequency of own controls; (c) 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.
(a) 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; (b) any other relevant documents deemed necessary by the control authority or control body to assess the request for retroactive recognition.
(a) 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; (b) 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; (c) 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.
(a) scientific and common name (common and Latin name); (b) variety; (c) total weight of seeds or number of plants concerned; (d) the availability of organic or in-conversion plant reproductive material; (e) 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.
(a) scientific and common name (common and Latin name, i.e. species and genus); (b) breeds and strains; (c) production purposes: meat, milk, eggs, dual purpose or breeding; (d) total number of animals; (e) availability of the relevant organic livestock species; (f) 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.
(a) species and genus (common and Latin name); (b) breeds and strains when applicable; (c) life stage (such as eggs, fry, juveniles) as available for sale as organic; (d) quantity available as estimated by the operator; (e) total number of juveniles; (f) availability of the relevant organic aquaculture species; (g) 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.
(a) 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; (b) in relation to specifically affected types of production or, where relevant, land parcels; and (c) to the individual operator or the member of the group of operators concerned.
(a) point 1.7.2 and the first paragraph of point 1.7.3 of Part I; (b) 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; (c) points 3.1.2.1 and 3.1.3.1 of Part III.
1.1. Assessment of the following: (a) the structure and size; (b) IT management system; (c) branch offices; (d) type of activities, including subcontracting activities other than inspection and sampling; (e) organisational chart; (f) quality management;
1.2. Assessment of the procedures for the exchanges of information between headquarter and branch offices, and subcontracted laboratories, as well as with the Commission, Member States, other control authorities and other control bodies; 1.3. Assessment of the knowledge and qualification of the staff as regards Union legislation on organic production rules and controls; 1.4. Verification that the language regime chosen and the documents issued by the control authority or control body are understandable for the contracted operators or groups of operators, in particular internal procedures for the staff involved in the certification process or in the controls; 1.5. Assessment of the continuous training programmes, and effective monitoring by the control authority or control body of the competencies acquired during the trainings; 1.6. Assessment of the experience and the competency of the staff on the category(ies) of products as set out in Article 35(7) of Regulation (EU) 2018/848 subject to the controls and in each third country covered by the recognition, including the employment status of inspectors concerned and their contractual relationship with the control body; 1.7. Assessment of the internal procedures related to the control activities in respect of operators and groups of operators, if any, and the specific skills and training required for the inspectors of the control authority or control body controlling the system for internal controls of groups of operators; 1.8. A description and an evaluation of the performance of the control system to be put in place for each third country, including where relevant, control specificities for groups of operators; 1.9. Any other information deemed necessary by the accreditation body.
2.1. An assessment report of the office(s) where certification decisions are taken, containing the following information: (a) result of the checking of files of all categories of products as set out in Article 35(7) of Regulation (EU) 2018/848 for which recognition is requested, and confirmation that the control body has correctly implemented the requirements on controls in respect of operators and groups of operators as set out in Chapter III of this Regulation and in particular Articles 9 and 10; (b) evaluation of the catalogue of measures to be taken in case of established non-compliance; (c) evaluation of the risk analysis procedures for the purpose of the inspections, including inspections without prior notice; (d) evaluation of the sampling strategy, procedure and methodology; (e) evaluation of the communication with the Commission and other control authorities and other control bodies; (f) conclusions from interviews with control and certification staff regarding their performance and competency on certification and control tasks; (g) confirmation that the control authority or control body has the means to implement the control system in line with this Regulation in each third country for which it requests recognition, in particular sufficient inspectors to carry out any physical checks at any stage of production, preparation and distribution, as appropriate, based on their risk assessment, additional inspections or samplings and documents in languages that are understandable by the contracted operators, when these documents are intended for operators or groups of operators; (h) confirmation of the capacity and competencies of the control authority or control body to perform its tasks for each third country for which it requests recognition, taking into account, in particular, the expected number of operators or members of the group of operators, volume of exported products, nature and origin of products, including evaluation of operators and inspectors files.
2.2. A witness audit report, resulting from a witness audit carried out in accordance with Part B, containing the following elements: (a) the name of the operator, the audited inspector and the accreditation body’s assessor; (b) general information about the witness audit such as venue, time, audit plan or parties, and the operator’s or group of operators’ experience with regard to organic production rules; (c) scope of inspection; (d) inspector preparation and knowledge, such as planning of work, working instructions, documents and material made available to the inspector, knowledge of the inspector on the relevant category of products, evaluation of the robustness of the organic system plan of the operator or the system of internal control of the group of operators, checking of conflicts of interest, knowledge on Regulation (EU) 2018/848, knowledge of the internal procedures of its control body as regard the functioning or the implementation of the control system and certification process; (e) inspector performance, such as relevance of the duration of the inspection, evaluation of the interview, verification of previous non-compliances, collection of relevant information, authority and analytical skills, conversation and questioning technique, effective language skills, knowledge of the local agricultural conditions and agricultural practices, processing practices in that country and social skills; (f) quality of the physical inspection of the facility/holding/unit such as methodology and quality of the inspection check list used, information provided by the operator in the organic system plan, robustness of the mass balance and traceability checks, the methodology used for the sampling and the inspection of critical areas; (g) findings, status of the non-compliances detected and corrective measures applied; (h) evaluation of the non-compliances identified by the accreditation body’s assessor but not detected by the inspector; (i) quality and completeness of the exit interview conducted; (j) overall assessment of the effectiveness of the inspection; (k) list of non-compliances detected, description and time line for the corrective measures to be carried out by the control authority or control body to solve them; (l) in the case of a group of operators, a specific section providing a description and evaluation of the effectiveness of the system for internal controls; and (m) an overall assessment of the capacity and reliability of the control authority or control body for performing the certification activities, taking into account the outcome of the assessment performed in accordance with section 2.1. Any other information deemed necessary by the accreditation body or competent authority, including for instance, reports and conclusions of additional witness audits.
(a) carried out by the accreditation body or, as appropriate, the competent authority; (b) based on a risk analysis and shall document the whole activity under witness; (c) carried out physically and may only be carried out remotely if so decided by the Commission.
(a) for each category of products as set out in Article 35(7) of Regulation (EU) 2018/848 for which the recognition is requested. All non-compliances detected by the accreditation body or competent authority shall be fully addressed by the control authority or control body respectively, and confirmed by the accreditation body or competent authority; (b) for each category of products in a different third country, if the control authority or control body requests or is already recognised for more than one third country; and (c) as a matter of priority in groups of operators, in case the control authority or control body certifies groups of operators.
(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 (b) in a third country for which the control authority or control body is recognised under Article 33(3) of Regulation (EC) No 834/2007.
(a) the control activities of the control authority or control body in the third country or third countries in the previous year, per category of products, as set out in Article 35(7) of Regulation (EU) 2018/848, including the information about the number of operators and groups of operators as well as the number of their members (including subcontractors, if the operators or groups of operators do not remain responsible for the subcontractors) which were subject to their controls on 31 December of the previous year, broken down by third country and category of products; (b) an undertaking that the control authority or control body has performed the required updates of the translation of the production rules according to Article 1(2)(e) of this Regulation or any other relevant documents required for the purposes of Article 46(2) of Regulation (EU) 2018/848 or this Regulation; (c) any update of the internal procedures, including the certification and control system set up by the control authority or control body in compliance with this Regulation; (d) a link to the website of the control authority or control body, with the information required in accordance with Article 17; (e) an annual assessment report of the office(s) where certification decisions are taken, as referred to in point 2.1 of Part A of Annex I: (i) ensuring that the control authority or control body has been satisfactorily assessed by the accreditation body or competent authority in the previous year on its ability to ensure that products imported from third countries comply with Regulation (EU) 2018/848; (ii) confirming that the control authority or control body still has the capacity and the 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, in each third country for which it is recognised; (iii) including any updated information of the annual assessment report as regards the results and an evaluation of: the checks of the files of the operators or groups of operators; the list of non-compliances, as well as the number of non-compliances in relation to the number of certified operators or groups of operators; the handling of non-compliances and complaints, if any, with an explanation on the corrective measures implemented by the operators or groups of operators for the lasting closure of its non-compliances; the catalogue of measures and its implementation; the risk analysis procedure; the annual risk plan; the sampling strategy, procedure and methodology; the changes to any of the procedures; the exchange of information with other control authorities, control bodies and the Commission; the competence of the staff involved in the inspection and certification process; the training programmes; the knowledge and competence of new staff; the effectiveness and reliability of the activity witnessed and an overall assessment of the performance of the control authority or control body; other elements that the accreditation body or competent authority considers relevant for the purposes of Regulation (EU) 2018/848;
(iv) confirming as regards the extensions of the scope of recognition to additional third countries or categories of products in the previous year, the capacity and competencies of the control authority or control body to perform controls in accordance with this Regulation in each new third country or for each new category of products concerned, if there are active operators or groups of operators.
(a) the number of physical on-the-spot inspections with and without prior notice; (b) the number of the samples collected in inspections with and without prior notice and where applicable, the actions taken; (c) the number of samples collected due to suspicion, complaints or during an investigation as referred to point (a) of Article 22(1) notified through OFIS as referred to in Article 21(2) (OFIS case); (d) the number of OFIS cases of suspected or established non-compliance; (e) the number of non-compliances found, broken down into minor, major and critical according to the classifications of non-compliances of organic or in-conversion products laid down in Annex IV; (f) measures referred to Annex IV taken in respect of operators or groups of operators in cases of non-compliances.
(a) the name of the operator or group of operators, its geographical location and its previous certificate number; (b) the name of its previous control authority or control body; (c) the date of transfer of the control file; (d) the list and nature of open non-compliances and measures required by the previous control authority or control body, if any; (e) the measures put in place by the operator or group of operators to ensure that the non-compliances will not occur again, and the date(s) of the inspection(s) carried out by the new control authority or control body to verify that corrective measures have been correctly implemented; (f) the indication whether the operator or group of operators was involved in any OFIS case.
(a) the list of the operators or groups of operators responsible for the high-risk products; (b) for each operator or group of operators: (i) the inspections carried out, indicating the date of each inspection; (ii) the sampling and analyses carried out; (iii) non-compliances found; (iv) the measures applied; (v) for each operator or group of operators that changed its control authority or control body, the corrective measures and/or sanctions applied if non-compliances were noted in the report of the previous control authority or control body;
(c) for each consignment showing a non-compliance: (i) reference to the certificate of inspection for imported consignments; (ii) overview of sampling analysis results that indicate the presence of residues of non-authorised substances; (iii) investigations and follow-up measures taken by the control authority or control body in case of commingling or residues of non-authorised substances found in the consignment, including the decision concerning the consignment as well as confirmation that operators have taken corrective measures.
(a) scientific and common name (common and Latin name); (b) variety; (c) number of derogations and total weight of seeds or number of plants derogated; (d) number of operators and groups of operators which have been granted an authorisation.
(a) scientific and common name (common and Latin name i.e. species and genus); (b) breeds and strains; (c) production purposes: meat, milk, eggs, dual purpose or breeding; (d) number of derogations and total number of animals derogated; (e) number of operators and groups of operators, which have been granted a derogation.
(a) species and genus (common and Latin name); (b) breeds and strains when applicable; (c) total number of derogations and number of juveniles for each species; (d) number of operators and groups of operators, which have been granted an authorisation.
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| For instance, have the operators concerned been submitted to a specific control?: |
| Have samples been taken and analysed?: |
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| What are the results of the inspections/analyses (if any)?: |
| Has the origin of the non-compliance/suspicion of non-compliance/other problem raised been cleared up?: |
| What is your assessment of the seriousness of the non-compliance/suspicion of non-compliance/other problem raised?: |
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| Comment on the origin of the contamination/non-compliance/other problem raised and the responsibility of the actors: |
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| Comment on the operators identified in other non-compliance/suspicion of non-compliance/other problems in the last 3 years: |
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| Was the certification of the producer/processor limited, suspended or withdrawn?: |
| Date of entry into force of the actions (if any) (DD/MM/YYYY): |
| Duration of the actions (if any) (in months): |
| Control authority and/or control body which adopted and applied the actions (if any): |
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| Reply comments: |
| Contact point |
(a) the case of non-compliance is minor when: (i) the precautionary measures put in place by the operator are proportionate and appropriate, and the controls that the operator has put in place are efficient according to the assessment by the control authority or control body; (ii) the non-compliance does not affect the integrity of the organic or in-conversion product; (iii) the traceability system can locate the affected product(s) in the supply chain and the product can be prevented from being imported from a third country for the purpose of placing that product on the market within the Union with reference to organic production;
(b) the case of non-compliance is major when: (i) the precautionary measures are not proportionate and appropriate and the controls that the operator has put in place are inefficient according to the assessment by the control authority or control body; (ii) the non-compliance affects the integrity of the organic or in-conversion product; (iii) the operator did not correct in a timely manner a minor non-compliance; (iv) the traceability can locate the affected product(s) in the supply chain and the product can be prevented from being imported from a third country for the purpose of placing that product on the market within the Union with reference to organic production;
(c) the case of non-compliance is critical when: (i) the precautionary measures are not proportionate and appropriate and the controls that the operator has put in place are inefficient according to the assessment by the control authority or control body; (ii) the non-compliance affects the integrity of the organic or in-conversion product; (iii) the operator fails to correct previous major non-compliances or repeatedly fails to correct other categories of non-compliances; and (iv) there is no information from the traceability system to locate the affected product(s) in the supply and the products cannot be prevented from being imported from a third country for the purpose of placing that product on the market within the Union with reference to organic production.
| Category of non-compliance | Measure |
|---|---|
| Minor | Submission by the operator of an action plan within a time limit setting on the correction of the non-compliance(s) |
| Major | |
| Critical |
| Non-compliance | Category |
|---|---|
| Significant deviation between input and output calculation (mass balance) | Major |
| Absence of records and financial records showing the compliance with Regulation (EU) 2018/848 | Critical |
| Intentional omission of information leading to incomplete records | Critical |
| Falsification of documents connected with the certification of organic products | Critical |
| Intentional re-labelling of downgraded products as organic | Critical |
| Intentional mixing organic with in-conversion or non-organic products | Critical |
| Intentional use of non-authorised substances or products within the scope of the Regulation (EU) 2018/848 | Critical |
| Intentional use of GMOs | Critical |
| The operator refuses the control authority or the control body access to premises subject to controls, or to its book keepings, including financial records, or refuses to allow the control authority or control body to take samples | Critical |