General provisions
1. 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.
2. 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.
3. Article 2 of Commission Delegated Regulation (EU) 2021/771 ( 5 ) and Articles 4, 5 and 6 of Commission Implementing Regulation (EU) 2021/279 ( 6 ) shall apply mutatis mutandis to controls in respect of groups of operators in third countries.
4. The control authority or control body shall carry out a verification of compliance with Regulation (EU) 2018/848 for all operators and groups of operators at least once a year. The verification of compliance shall include a physical on-the-spot inspection.
5. The control authority or control body shall ensure that it carries out every year at least 10 % of additional controls to those referred to in paragraph 4. Of all physical on-the-spot inspections carried out by the control authority or control body, at least 10 % shall be without prior notice.
6. Controls carried out as a follow-up on a suspected or established non-compliance shall not count towards the additional controls referred to in paragraph 5.
7. Every year, the control authority or control body shall re-inspect at least 5 % of the members of a group of operators, but not less than 10 members. Where the group of operators has 10 members or less, all members shall be re-inspected.
8. The physical on-the-spot inspection and the sampling shall be carried out by the control authority or control body at the most appropriate times in order to verify compliance on critical control points.
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.
9. Where operators or groups of operators run several production units or premises, including purchase and collection centres, all production units or premises, including purchase and collection centres, used for non-organic products shall also be subject to the control requirements set out in paragraph 4.
10. The delivery or renewal of the certificate referred to in point (b)(i) of Article 45(1) of Regulation (EU) 2018/848 shall be based on the results of the verification of compliance referred to in this Article.
Checks for the certification of operators or groups of operators
1. 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;
(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.
2. Before certifying operators or groups of operators, the control authority or control body shall verify:
(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.
3. Besides any other element that may be considered relevant by the control authority or control body, before certifying operators or groups of operators that were previously certified by another control authority or control body, the new control authority or control body shall assess the following information to be transmitted by the previous control authority or control body:
(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.
If the previous control authority or control body does not transmit the information as required in Article 21(5) of this Regulation to the new control authority or control body or in case of doubts concerning the information transmitted, the new control authority or control body shall not issue the certificate referred to in point (b)(i) of Article 45(1) of Regulation (EU) 2018/848 to operators or groups of operators until this new control authority or control body has eliminated their doubts by other means of control.
4. The control authority or control body shall not certify operators or groups of operators that have been withdrawn by their previous control authority or control body in the last 2 years, unless the recognition of the previous control authority or control body has been withdrawn by the Commission in accordance with Article 46(2a) of Regulation (EU) 2018/848 for the specific third country and category of products.
Methods and techniques for controls
1. Control methods and techniques applied by a control authority or control body shall include the following:
(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.
2. The annual physical on-the-spot inspection referred to in Article 9(4) shall include a traceability check and a mass balance check of the operators or groups of operators, carried out by means of checks of documentary accounts and of any other relevant element deemed necessary by the control authority or control body.
3. For the purpose of the traceability check and the mass balance check, the selection of products, groups of products and period under verification shall be based on a risk assessment by the control authority or control body.
4. Besides any other relevant element deemed necessary by the control authority or control body, the traceability check shall cover the following elements justified by appropriate documents including stock and financial records:
(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.
5. The mass balance check shall cover the following elements justified by appropriate documents including stock and financial records, where relevant:
(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.
Sampling, methods used for sampling and selection of laboratories for sample analysis
1. The control authority or control body shall take and analyse samples for detecting the use of non-authorised products and substances for organic production, for checking production techniques not in compliance with the organic production rules or for detecting possible contamination by non-authorised products and substances for organic production.
2. The control authority or control body shall carry out sampling on at least 5 % of the number of individual operators under its control. For a group of operators, the control authority or control body carry out sampling on at least 2 % of the members of each group.
3. The selection of the operators and groups of operators where samples have to be taken shall be based on risk assessment including the likelihood of non-compliance with the organic production rules, taking into account all stages of production, preparation and distribution.
4. In addition to the minimum sampling rate set in paragraph 2, the control authority or control body shall take and analyse samples in each case where the use of non-authorised products and substances or techniques for organic production is suspected, unless the control authority or control body considers that sufficient evidence is available without sampling.
5. For the high-risk products referred to in Article 8, the control authority or control body shall take, in addition to the sampling rate set in paragraphs 2 and 3 of this Article, at least one field sample of the crop each year. That sample shall be taken from crops in the field, at the most appropriate moment to detect potential use of non-authorised substances according to the assessment of the control authority or control body. For operators not growing crops, a relevant sample of incoming raw material or intermediate product or processed product shall be taken.
6. The control authority and control body shall ensure that the laboratories used comply with the following:
(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 ( 7 ) .
7. The control authority or control body may delegate sampling tasks to other control authorities or control bodies recognised by the Commission or bodies accredited in accordance with ISO standard ISO/IEC 17025 on ‘General requirements for the competence of testing and calibration laboratories’.
Documented control procedures
1. Control authorities and control bodies shall perform controls on operators and groups of operators in accordance with documented procedures.
Those documented procedures shall cover:
(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.
2. Control authorities and control bodies shall:
(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.
Written records of controls
1. Control authorities and control bodies shall draw up written records of each control they perform to verify compliance with Regulation (EU) 2018/848. Those records may be on paper or in electronic form. The control authorities and control bodies shall keep these records for 5 years from the day of the decision on certification by the control authority or control body.
Those records shall contain in particular:
(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.
2. The written records shall be countersigned by the operator or the inspected member of the group of operators as confirmation of their receipt of that written record. A copy of that record shall be kept by the operator or the inspected member of the group of operators either on paper or in electronic form.
Specific control requirements for algae and aquaculture animal production
1. For the purpose of determining the start of the conversion period provided in Article 10(2) of Regulation (EU) 2018/848, the control authority or control body shall ensure that operators or groups of operators producing algae or aquaculture animals notify the control authority or control body of the relevant activity.
2. The control authority or control body shall ensure that organic production of algae or aquaculture animals takes place in a location with no risk of contamination in accordance with point 1.1 of Part III of Annex II to Regulation (EU) 2018/848. In particular, the control authority or control body shall ensure that adequate separation measures have been taken in accordance with point 1.2 of that Part III.
3. For the purposes of point 3.1.3.1(c) of Part III of Annex II to Regulation (EU) 2018/848, the control authority or control body shall ensure that the plant fraction of feed is organic and the feed fraction derived from aquatic animals originates from organic aquaculture or from fisheries that have been certified as sustainable in line with the 2009 FAO’s Guidelines for the ecolabelling of fish and fisheries products from marine capture fisheries.
4. For the purposes of point 3.1.4.2(e) of Part III of Annex II to Regulation (EU) 2018/848, the control authority or control body shall ensure that they have information on all treatments, and they shall check that these treatments are carried out in accordance with the requirements of that Regulation.
5. For the purpose of authorising the use of wild seed within the meaning of point 3.2.1 of Part III of Annex II to Regulation (EU) 2018/848, the control authority or control body shall ensure that points (a), (b) and (c) of that point are respected.
Verification of consignments intended for import into the Union
1. The relevant control authority or control body shall verify consignments intended for import into the Union with regard to the compliance with Regulation (EU) 2018/848 and this Regulation. This verification shall include systematic documentary checks and, as appropriate according to a risk assessment, physical checks, before the consignment leaves the third country of export or of origin.
2. For the purposes of this Article, the relevant control authority or control body shall be:
(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.
The relevant control authority or control body shall be recognised in accordance with Article 46(1) of Regulation (EU) 2018/848 for the products concerned and for the third country in which the products have their origin, or, where applicable, in which the last operation for the purpose of preparation has been carried out.
3. The documentary checks referred to in paragraph 1 shall aim at verifying:
(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.
Those documentary checks shall be based on all relevant documents, including the certificate referred to in point (b)(i) of Article 45(1) of Regulation (EU) 2018/848, the latest record of the inspections, the production plan for the product concerned and records kept by the operators or groups of operators, available transport documents, commercial and financial documents and any other documents deemed relevant by the control authority or control body.
4. In relation to the risk assessment preceding physical checks as referred to in paragraph 1, the relevant control authority or control body shall take into account the following criteria:
(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.
5. For consignments made out of bulk organic products, the relevant control authority or control body shall draw up a travel plan in the Trade Control and Expert System (TRACES), including all the premises to be used during the travel from the third country of origin or export to the Union.
6. For consignments of high-risk products referred to in Article 8, the relevant control authority or control body shall carry out systematic physical checks and take at least one representative sample of each consignment. Moreover, the control authority or control body shall have complete documentation of the traceability of the operators or groups of operators and the product, including transport and commercial documents, including invoices. At the request of the Commission or the competent authority of a Member State, the control authority or control body shall send this traceability documentation as well as the results of the sampling analysis to the control authority or control body of the importer and to the competent authority of the Member State where the consignment is verified.
7. In case of suspicion of non-compliance, the Commission or the competent authority of a Member State may request the relevant control authority or control body to make available without delay the list of all operators and all groups of operators in the organic production chain of which the consignment is part, and of their control authorities or control bodies.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
