List of operators and other relevant information to be publicly available
The control authority or control body shall make the following information available on its website, in at least one official language of the Union:
(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.
The list referred to in point (a) shall be immediately updated after any change of the status of the certification. In case of withdrawal, the information referred to in point (a)(iii) shall be kept in the list for 5 years after the withdrawal;
Database of operators and groups of operators
The control authority or control body shall keep an updated electronic database of operators and groups of operators. That database shall include the following information:
(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.
The information shall be kept by the control authority or control body for 5 years. The control authority or control body shall make that information available to the Commission upon request.
Information requirements
1. After its recognition, the control authority or control body shall notify the Commission in due time, and not later than within 30 calendar days, of the occurrence of changes to the content of its technical dossier.
2. The control authority or control body shall keep available and communicate at the request of the Commission or the competent authorities of the Member States all information related to its control activities in the third country.
3. The supporting documents relating to the request for recognition under Article 46 of Regulation (EU) 2018/848 and those required under this Regulation shall be kept by the control authorities or control bodies at the disposal of the Commission and the Member States for 5 years following the year in which the controls took place or the certificate referred to in point (b)(i) of Article 45(1) of Regulation (EU) 2018/848 and documentary evidence were delivered.
Systems and procedures for the exchange of information
1. The control authority or control body shall use the Organic Farming Information System (OFIS) for the exchange of information with the Commission, with other control authorities and other control bodies, and with the competent authorities of the Member States and of the third countries concerned.
2. The control authority or control body shall take the appropriate measures and establish documented procedures to ensure timely exchanges of information with the Commission and with other control authorities and control bodies.
3. Where a document or procedure provided for in Article 46 of Regulation (EU) 2018/848 or in the delegated and implementing acts adopted pursuant to that Article requires the signature of an authorised person or the approval by a person at one or more of the stages of that procedure, the computer systems set up for the communication of those documents shall make it possible to identify each person and guarantee that the integrity of the content of the documents, including as regards the stages of the procedure, cannot be altered, in accordance with Union law, and in particular with Commission Decision 2004/563/EC, Euratom ( 8 ) .
Exchange of information between the Commission, control authorities, control bodies and competent authorities
1. The control authority or control body shall immediately share information with the Commission, with other control authorities and control bodies, and with the competent authorities of the Member States and of the third countries concerned on any suspicion of non-compliance that affects the integrity of organic or in-conversion products.
2. Where a control authority or control body is notified by the Commission, after the Commission has received a notification from a Member State in accordance with Article 9 of Implementing Regulation (EU) 2021/279 as regards suspected or established non-compliance affecting the integrity of imported organic or in-conversion products, it shall carry out an investigation in accordance with Article 22 of this Regulation. The control authority or control body shall inform the Commission and the Member State that sent the initial notification (notifying Member State), using the template set out in Annex III to this Regulation. The control authority or control body shall reply within 30 calendar days from the date of receiving that notification and shall inform about the actions and measures taken, including the results of the investigation and provide any other information when available and/or required by the notifying Member State.
3. The notified control authority or control body shall provide further necessary information if requested by the notifying Member State.
4. Where operators or groups of operators and/or their subcontractors are subject to controls by different control authorities or control bodies, those control authorities or control bodies shall exchange the relevant information on the operations covered by their control activities.
5. Where operators or groups of operators and/or their subcontractors change their control authority or control body, the new control authority or control body shall request the control file of the operator or group of operators concerned from the previous control authority or control body. The previous control authority or control body shall, within 30 days, provide to the new control authority or control body the control file of the operator or group of operators concerned and the written records referred to in Article 14, the status of the certification, the list of non-compliances and the corresponding measures taken by the previous control authority or control body.
The new control authority or control body shall ensure that non-compliances noted in the report of the previous control authority or control body have been addressed by the operators or groups of operators.
6. Where operators or groups of operators are subject to a traceability check and a mass balance check, control authorities and control bodies shall exchange the relevant information allowing finalisation of these checks.
Additional rules on actions to be taken in case of non-compliance
1. In addition to the measures referred to in Article 29(1), (2) and (3) of Regulation (EU) 2018/848 and Article 2 of Implementing Regulation (EU) 2021/279, where a control authority or control body suspects or receives substantiated information, including information from other control authorities or control bodies, that a product, which may not be in compliance with Regulation (EU) 2018/848, is intended to be imported from a third country for the purpose of placing that product on the market within the Union, but which bears terms referring to the organic production, or where such a control authority or control body has been informed by an operator of a suspicion of non-compliance in accordance with Article 27 of that Regulation:
(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.
2. In the event that the results of the investigation referred to in point (a) of paragraph 1 do not show any non-compliance affecting the integrity of organic or in-conversion products, those products shall be allowed to be used and labelled as organic or in-conversion products.
3. The control authority or control body shall develop a catalogue of measures to be taken in case of established non-compliance. That catalogue of measures shall be based on the elements specified in Annex IV to this Regulation and shall cover at least:
(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.
4. The control authority or control body shall document the results of the investigations referred to in point (a) of Article 29(1) of Regulation (EU) 2018/848.
Additional rules on measures in the event of non-compliance
1. In the event of non-compliance affecting the integrity of organic or in-conversion products throughout any of the stages of production, preparation and distribution, for example as a result of the use of non-authorised products, substances or techniques, or commingling with non-organic products, the control authority or control body shall ensure, in addition to the measures to be taken in accordance with paragraphs 2 and 3 of this Article, that no reference is made to organic production as set out in Chapter IV of Regulation (EU) 2018/848, in the labelling and advertising of the entire lot or production run of the product intended to be imported from a third country for the purpose of placing that product on the market within the Union.
2. Where the non-compliance is established, the control authority or control body shall:
(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.
When deciding which measures to take, the control authority or control body shall take account of the nature of that non-compliance and the past record of the operator or of the group of operators with regard to compliance.
3. When acting in accordance with paragraph 2 of this Article, the control authority or control body shall take any measure it deems appropriate to ensure compliance with Regulation (EU) 2018/848 and the delegated and implementing acts adopted pursuant that Regulation, including:
(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.
4. In the event of serious, or repetitive or continued non-compliance, the control authority or control body shall ensure that the operator or group of operators, in addition to the measures laid down in paragraphs 2 and 3, is prohibited from placing on the market within the Union for a given period products which refer to organic production, and that its certificate referred to in point (b)(i) of Article 45(1) of Regulation (EU) 2018/848 be suspended or withdrawn, as appropriate.
5. The control authority or control body shall provide the operator or group of operators with a written notification of its decision concerning the action or measure to be taken in accordance with this Article, together with the reasons for that decision.
Checks to be carried out for the purpose of the retroactive recognition of a previous period
1. Before granting retroactive recognition of a previous period as part of the conversion period for the purposes of point (b) of Article 10(3) of Regulation (EU) 2018/848, the control authority or control body shall ensure that the operator submits the following documents proving that the land parcels were natural or agricultural areas that, for a period of at least 3 years, have not been treated or have not been contaminated with products or substances that are not authorised for use in organic production in accordance with Regulation (EU) 2018/848:
(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.
2. In addition, the control authority or control body shall take the following steps:
(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.
3. Based on the information provided by the operator in accordance with paragraph 1 and after having completed the steps set out in paragraph 2, the control authority or control body shall draw up a final written report. The final written report shall include a justification why the previous period can be recognised retroactively as part of the conversion period. This final written report shall also indicate the starting period considered as organic for each land parcel concerned as well as the total surface of the land parcels benefiting from this retroactive recognition of a period.
4. The control authority or control body shall immediately notify the Commission, the Member States and in case of a control body its accreditation body of any retroactive recognition granted. For each retroactive recognition granted, the control authority or control body shall provide the final written report referred to in paragraph 3.
5. The control authority or control body shall ensure that the operator to whom the granted retroactive recognition applies keeps documentary evidence relating to that recognition, as well as documentary evidence on the use of the land parcels covered by that recognition, for 3 years.
Authorisations for the use of non-organic plant reproductive material
1. Before granting authorisations for the use of non-organic plant reproductive material as set out in point 1.8.5.2 of Part I of Annex II to Regulation (EU) 2018/848, the control authority or control body shall assess the following information and draw up a justification for each derogation granted:
(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.
2. For each authorisation for the use of non-organic plant reproductive material as set out in point 1.8.5.2 of Part I of Annex II to Regulation (EU) 2018/848, the control authority or control body shall include the relevant information in the annual report referred to in Article 4 of this Regulation.
Derogations as regards the use of non-organic animals and aquaculture juveniles
1. Before granting derogations as regards the use of non-organic livestock species (bovine, equine, ovine, caprine, porcine and cervine animals, rabbits, and poultry) in accordance with points 1.3.4.3 and 1.3.4.4 of Part II of Annex II to Regulation (EU) 2018/848, the control authority or control body shall assess the following information and draw up a justification for each derogation:
(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.
2. For each non-organic livestock species (bovine, equine, ovine, caprine, porcine and cervine animals, rabbits, and poultry), the control authority or control body shall include the relevant information on the derogations granted in accordance with points 1.3.4.3 and 1.3.4.4 of Part II of Annex II to Regulation (EU) 2018/848 in the annual report referred to in Article 4 of this Regulation.
3. Before granting derogations as regards the use of non-organic aquaculture juveniles in accordance with point 3.1.2.1 of Part III of Annex II to Regulation (EU) 2018/848, the control authority or control body shall assess the following information and draw up a justification for each derogation:
(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.
4. For each derogation granted as regards the use of non-organic aquaculture juveniles in accordance with point 3.1.2.1 of Part III of Annex II to Regulation (EU) 2018/848, the control authority or control body shall include the relevant information in the annual report referred to in Article 4 of this Regulation.
Reporting on provisional authorisation for the use of non-organic agricultural ingredients for processed organic food
The control authority or control body shall immediately notify the Commission, the Member States, accreditation bodies and other control authorities and control bodies recognised in accordance with Article 46(1) of Regulation (EU) 2018/848 of any provisional authorisation granted for the use of non-organic agricultural ingredients for processed organic food in accordance with Article 25(4) of that Regulation. That notification shall include the justification, presented in the dedicated form made available by the Commission, that such authorisation has been granted in accordance with Article 25(1) of Regulation (EU) 2018/848.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
