Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007

• (a) it shall immediately carry out an official investigation in accordance with Regulation (EU) 2017/625 with a view to determining the source and the cause in order to verify compliance with the first subparagraph of Article 9(3) and with Article 28(1); 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 provisionally prohibit both the placing on the market of the products concerned as organic or in-conversion products and their use in organic production pending the results of the investigation referred to in point (a).

• (a) has used products or substances not authorised pursuant to the first subparagraph of Article 9(3) for use in organic production;

• (b) has not taken the precautionary measures referred to in Article 28(1); or

• (c) has not taken measures in response to relevant previous requests from the competent authorities, control authorities or control bodies.

Where required, the operator concerned shall take such corrective measures as necessary to avoid future contamination.

Member States shall make such information available to the other Member States and to the Commission via a computer system that enables the electronic exchange of documents and information made available by the Commission.

• (a) the methodology to be applied by competent authorities, or, where appropriate, by control authorities or control bodies, for the detection and evaluation of the presence of products and substances not authorised pursuant to the first subparagraph of Article 9(3) for use in organic production;

• (b) the details and format of the information to be made available by Member States to the Commission and other Member States in accordance with paragraph 6 of this Article.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

CHAPTER IV LABELLING

Article 30

Use of terms referring to organic production

Furthermore, no terms, including terms used in trademarks or company names, or practices shall be used in labelling or advertising if they are liable to mislead the consumer or user by suggesting that a product or its ingredients comply with this Regulation.

However, plant reproductive material, food products of plant origin and feed products of plant origin that have been produced during the conversion period, which comply with Article 10(4), may be labelled and advertised as in-conversion products by using the term ‘in-conversion’ or a corresponding term, together with the terms referred to in paragraph 1.

• (a) in the sales description, and in the list of ingredients where such a list is mandatory pursuant to Union legislation, provided that:
• (i) the processed food complies with the production rules set out in Part IV of Annex II and with the rules laid down in accordance with Article 16(3);
• (ii) at least 95 % of the agricultural ingredients of the product by weight are organic; and
• (iii) in the case of flavourings, they are only used for natural flavouring substances and natural flavouring preparations labelled in accordance with Article 16(2), (3) and (4) of Regulation (EC) No 1334/2008 and all of the flavouring components and carriers of flavouring components in the flavouring concerned are organic;

• (b) only in the list of ingredients, provided that:
• (i) less than 95 % of the agricultural ingredients of the product by weight are organic, and provided that those ingredients comply with the production rules set out in this Regulation; and
• (ii) the processed food complies with the production rules set out in points 1.5, 2.1(a), 2.1(b) and 2.2.1 of Part IV of Annex II, with the exception of the rules on restricted use of non-organic agricultural ingredients set out in point 2.2.1 of Part IV of Annex II, and with the rules laid down in accordance with Article 16(3);

• (c) in the sales description and in the list of ingredients, provided that:
• (i) the main ingredient is a product of hunting or fishing;
• (ii) the term referred to in paragraph 1 is clearly related in the sales description to another ingredient which is organic and different from the main ingredient;
• (iii) all other agricultural ingredients are organic; and
• (iv) the processed food complies with the production rules set out in points 1.5, 2.1(a), 2.1(b) and 2.2.1 of Part IV of Annex II, with the exception of the rules on restricted use of non-organic agricultural ingredients set out in point 2.2.1 of Part IV of Annex II, and with the rules laid down in accordance with Article 16(3).

The list of ingredients referred to in points (a), (b) and (c) of the first subparagraph shall indicate which ingredients are organic. The references to organic production may only appear in relation to the organic ingredients.

The list of ingredients referred to in points (b) and (c) of the first subparagraph shall include an indication of the total percentage of organic ingredients in proportion to the total quantity of agricultural ingredients.

The terms referred to in paragraph 1, when used in the list of ingredients referred to in points (a), (b), and (c) of the first subparagraph of this paragraph, and the indication of the percentage referred to in the third subparagraph of this paragraph shall appear in the same colour, identical size and style of lettering as the other indications in the list of ingredients.

• (a) the processed feed complies with the production rules set out in Parts II, III and V of Annex II and with the specific rules laid down in accordance with Article 17(3);

• (b) all of the ingredients of agricultural origin that are contained in the processed feed are organic; and

• (c) at least 95 % of the dry matter of the product are organic.

• (a) this Article by adding further rules on the labelling of products listed in Annex I, or by amending those added rules; and

• (b) the list of terms set out in Annex IV, taking into account linguistic developments within the Member States.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

Article 31

Labelling of products and substances used in crop production

Notwithstanding the scope of this Regulation as set out in Article 2(1), products and substances used in plant protection products or as fertilisers, soil conditioners or nutrients that have been authorised in accordance with Articles 9 and 24 may bear a reference indicating that those products or substances have been authorised for use in organic production in accordance with this Regulation.

Article 32

Compulsory indications

• (a) the code number of the control authority or control body to which the operator that carried out the last production or preparation operation is subject shall also appear in the labelling; and

• (b) in the case of prepacked food, the organic production logo of the European Union referred to in Article 33 shall also appear on the packaging, except in cases referred to in Article 30(3) and points (b) and (c) of Article 30(5).

• (a) ‘EU Agriculture’, where the agricultural raw material has been farmed in the Union;

• (b) ‘non-EU Agriculture’, where the agricultural raw material has been farmed in third countries;

• (c) ‘EU/non-EU Agriculture’, where a part of the agricultural raw materials has been farmed in the Union and a part of it has been farmed in a third country.

For the purposes of the first subparagraph, the word ‘Agriculture’ may be replaced by ‘Aquaculture’ where appropriate and the words ‘EU’ and ‘non-EU’ may be replaced or supplemented by the name of a country, or by the name of a country and a region, if all of the agricultural raw materials of which the product is composed have been farmed in that country and, if applicable, in that region.

For the indication of the place where the agricultural raw materials of which the product is composed have been farmed, as referred to in the first and third subparagraphs, small quantities by weight of ingredients may be disregarded, provided that the total quantity of the disregarded ingredients does not exceed 5 % of the total quantity by weight of agricultural raw materials.

The words ‘EU’ or ‘non-EU’ shall not appear in a colour, size and style of lettering that is more prominent than the name of the product.

• (a) practical arrangements for the use, presentation, composition and size of the indications referred to in point (a) of paragraph 1 and in paragraph 2 of this Article and in Article 33(3);

• (b) the assignment of code numbers to control authorities and control bodies;

• (c) the indication of the place where the agricultural raw materials were farmed, in accordance with paragraph 2 of this Article and with Article 33(3).

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

Article 33

Organic production logo of the European Union

The organic production logo of the European Union may also be used for information and educational purposes related to the existence and advertising of the logo itself, provided that such use is not liable to mislead the consumer as regards the organic production of specific products, and provided that the logo is reproduced in accordance with the rules set out in Annex V. In such case, the requirements of Article 32(2) and point 1.7 of Annex V shall not apply.

The organic production logo of the European Union shall not be used for processed food as referred to in points (b) and (c) of Article 30(5) and for in-conversion products as referred to in Article 30(3).

CHAPTER V CERTIFICATION

Article 34

Certification system

Where the competent authorities have conferred their responsibilities or delegated certain official control tasks or certain tasks related to other official activities to more than one control authority or control body, the operators or groups of operators shall indicate in the notification referred to in the first subparagraph which control authority or control body verifies whether their activity complies with this Regulation and provides the certificate referred to in Article 35(1).

• (a) the format and technical means of the notification referred to in paragraph 1;

• (b) the arrangements for the publication of the lists referred to in paragraph 6; and

• (c) the procedures and the arrangements for publication of the fees referred to in paragraph 7.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

Article 35

Certificate

• (a) be issued in electronic form wherever possible;

• (b) allow at least the identification of the operator or group of operators including the list of the members, the category of products covered by the certificate and its period of validity;

• (c) certify that the notified activity complies with this Regulation; and

• (d) be issued in accordance with the model set out in Annex VI.

• (a) unprocessed plants and plant products, including seeds and other plant reproductive material;

• (b) livestock and unprocessed livestock products;

• (c) algae and unprocessed aquaculture products;

• (d) processed agricultural products, including aquaculture products, for use as food;

• (e) feed;

• (f) wine;

• (g) other products listed in Annex I to this Regulation or not covered by the previous categories.

• (a) such sales do not exceed 5 000  kg per year;

• (b) such sales do not represent an annual turnover in relation to unpacked organic products exceeding EUR 20 000 ; or

• (c) the potential certification cost of the operator exceeds 2 % of the total turnover on unpacked organic products sold by that operator.

If a Member State decides to exempt the operators referred to in the first subparagraph, it may set stricter limits than those set in the first subparagraph.

Member States shall inform the Commission and the other Member States of any decision to exempt operators pursuant to the first subparagraph and of the limits up to which such operators are exempted.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

Article 36

Group of operators

• (a) only be composed of members who are farmers or operators that produce algae or aquaculture animals and who in addition may be engaged in processing, preparation or placing on the market of food or feed;

• (b) only be composed of members:
• (i) of which the individual certification cost represents more than 2 % of each member’s turnover or standard output of organic production and whose annual turnover of organic production is not more than EUR 25 000 or whose standard output of organic production is not more than EUR 15 000 per year; or
• (ii) who have each holdings of maximum:
• — five hectares,
• — 0,5 hectares, in the case of greenhouses, or
• — 15 hectares, exclusively in the case of permanent grassland;

• (c) be established in a Member State or a third country;

• (d) have legal personality;

• (e) only be composed of members whose production activities or possible additional activities referred to in point (a) take place in geographical proximity to each other in the same Member State or in the same third country;

• (f) set up a joint marketing system for the products produced by the group; and

• (g) establish a system for internal controls comprising a documented set of control activities and procedures in accordance with which an identified person or body is responsible for verifying compliance with this Regulation of each member of the group. The system for internal controls (ICS) shall comprise documented procedures on:
• (i) the registration of the members of the group;
• (ii) the internal inspections, which include the annual internal physical on-the-spot inspections of each member of the group, and any additional risk-based inspections, in any case scheduled by the ICS manager and conducted by ICS inspectors, whose roles are defined in point (h);
• (iii) the approval of new members in an existing group or, where appropriate, the approval of new production units or new activities of existing members upon the approval by the ICS manager on the basis of the internal inspection report;
• (iv) the training of the ICS inspectors, which is to take place at least annually and to be accompanied by an assessment of the knowledge acquired by the participants;
• (v) the training of members of the group on the ICS procedures and the requirements of this Regulation;
• (vi) the control of documents and records;
• (vii) the measures in cases of non-compliance detected during the internal inspections, including their follow-up;
• (viii) the internal traceability, which shows the origin of the products delivered in the joint marketing system of the group and allows the tracing of all products of all members throughout all stages, such as production, processing, preparation or placing on the market, including estimating and cross-checking the yields of each member of the group;

• (h) appoint an ICS manager and one or more ICS inspectors who may be a member of the group. Their positions shall not be combined. The number of ICS inspectors shall be adequate and proportional in particular to the type, structure, size, products, activities and output of organic production of the group. The ICS inspectors shall be competent with regard to the products and activities of the group. The ICS manager shall:
• (i) verify the eligibility of each member of the group regarding the criteria set out in points (a), (b) and (e);
• (ii) ensure that there is a written and signed membership agreement between each member and the group, by which the members commit themselves to:
• — comply with this Regulation,
• — participate in the ICS and comply with the ICS procedures, including the tasks and responsibilities assigned to them by the ICS manager and the obligation for records keeping,
• — permit access to production units and premises and be present during the internal inspections carried out by the ICS inspectors and official controls carried out by the competent authority or, where appropriate, the control authority or control body, make available to them all documents and records and countersign the inspection reports,
• — accept and implement the measures in cases of non-compliances in accordance with the decision of the ICS manager or the competent authority or, where appropriate, the control authority or control body, within the given time-frame,
• — immediately inform the ICS manager on suspected non-compliance;
• (iii) develop the ICS procedures and the relevant documents and records, keep them up to date and make them readily available to the ICS inspectors, and where relevant, to the members of the group;
• (iv) draw up the list of the members of the group and keep it up to date;
• (v) assign tasks and responsibilities to the ICS inspectors;
• (vi) be the liaison between the members of the group and the competent authority or, where appropriate, the control authority or control body, including requests for derogations;
• (vii) verify annually the conflict of interest statements of the ICS inspectors;
• (viii) schedule internal inspections and ensure their adequate implementation in accordance with the ICS manager’s schedule referred to in point (ii) of the second paragraph of point (g);
• (ix) ensure adequate trainings for the ICS inspectors and carry out an annual assessment of ICS inspectors’ competences and qualifications;
• (x) approve new members or new production units or new activities of existing members;
• (xi) decide on measures in case of non-compliance in line with the ICS measures established by documented procedures in accordance with point g and ensure the follow-up of those measures;
• (xii) decide to subcontract activities, including the subcontracting of the tasks of ICS inspectors, and sign relevant agreements or contracts. The ICS inspector shall:
• (i) carry out internal inspections of the members of the group according to the schedule and the procedures provided by the ICS manager;
• (ii) draft internal inspection reports on the basis of a template and submit it within a reasonable time to the ICS manager;
• (iii) submit at appointment a written and signed statement on conflict of interest and update it annually;
• (iv) participate in trainings.

At least the following situations shall be considered as deficiencies in the ICS:

• (a) producing, processing, preparing or placing on the market of products from suspended/withdrawn members or production units;

• (b) placing on the market of products for which the ICS manager has prohibited the use of reference to organic production in their labelling or advertising;

• (c) adding new members to the list of members or changing the activities of existing members without following the internal approval procedure;

• (d) not carrying out the annual physical on-the-spot inspection of a member of the group in a given year;

• (e) failing to indicate the members which have been suspended or withdrawn in the list of members;

• (f) serious deviations in findings between internal inspections carried out by the ICS inspectors and official controls carried out by the competent authority or, where appropriate, the control authority or control body;

• (g) serious deficiencies in imposing appropriate measures or carrying out the necessary follow-up in response to non-compliance identified by the ICS inspectors or by the competent authority or, where appropriate, the control authority of control body;

• (h) inadequate number of ICS inspectors or inadequate competences of ICS inspectors for the type, structure, size, products, activities and output of organic production of the group.

• (a) the responsibilities of the individual members of a group of operators;

• (b) the criteria to determine the geographical proximity of the members of the group, such as the sharing of facilities or sites;

• (c) the set-up and functioning of the system for internal controls, including the scope, content and frequency of the controls to be carried out and the criteria to identify deficiencies in the set-up or functioning of the system for internal controls.

• (a) the composition and dimension of a group of operators;

• (b) the documents and record-keeping systems, the system for internal traceability and the list of operators;

• (c) the exchange of information between a group of operators and the competent authority or authorities, control authorities or control bodies, and between the Member States and the Commission.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

CHAPTER VI OFFICIAL CONTROLS AND OTHER OFFICIAL ACTIVITIES

Article 37

Relationship with Regulation (EU) 2017/625 and additional rules for official controls and other official activities in relation to organic production and labelling of organic products

The specific rules of this Chapter shall apply, in addition to the rules laid down in Regulation (EU) 2017/625, save as otherwise provided for in Article 40(2) of this Regulation, and in addition to Article 29 of this Regulation, save as otherwise provided for in Article 41(1) of this Regulation, to the official controls and other official activities performed to verify throughout the entire process at all stages of production, preparation and distribution that the products referred to in Article 2(1) of this Regulation have been produced in compliance with this Regulation.

Article 38

Additional rules on official controls and on action to be taken by the competent authorities

• (a) the verification of the application by operators of preventive and precautionary measures, as referred to in Article 9(6) and in Article 28 of this Regulation, 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, where appropriate, measures to prevent substitution of products are implemented, that organic products and in-conversion products are identified at all times and that organic, in-conversion and non-organic products are stored, before and after the preparation operations, separated by place or time from each other;

• (d) the verification of the set-up and functioning of the internal control system of groups of operators;

• (e) where operators are exempted from the notification obligation in accordance with Article 34(2) of this Regulation or from the obligation to be in the possession of a certificate in accordance with Article 35(8) of this Regulation, the verification that the requirements for that exemption have been fulfilled and the verification of the products sold by those operators.

• (a) the type, size and structure of the operators and groups of operators;

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

• (c) the results of the controls performed in accordance with this Article;

• (d) the point in time relevant for the activities carried out;

• (e) the product categories;

• (f) the type, quantity and value of products and their development over time;

• (g) the possibility of commingling of products or contamination with non-authorised products or substances;

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

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

• (j) subcontracting activities.

The verification of compliance shall include a physical on-the-spot inspection, except where the following conditions have been satisfied:

• (a) the previous controls of the operator or group of operators concerned have not revealed any non-compliance affecting the integrity of organic or in-conversion products during at least three consecutive years; and

• (b) the operator or group of operators concerned has been assessed on the basis of the elements referred to in paragraph 2 of this Article and in Article 9 of Regulation (EU) 2017/625 as presenting a low likelihood of non-compliance.

In this case, the period between two physical on-the-spot inspections shall not exceed 24 months.

• (a) be performed in accordance with Article 9(4) of Regulation (EU) 2017/625 while ensuring that a minimum percentage of all official controls of operators or groups of operators are carried out without prior notice;

• (b) ensure that a minimum percentage of additional controls to those referred in paragraph 3 of this Article are carried out;

• (c) be carried out by taking a minimum number of the samples that have been taken in accordance with point (h) of Article 14 of Regulation (EU) 2017/625;

• (d) ensure that a minimum number of operators that are members of a group of operators are controlled in connection with the verification of compliance referred to in paragraph 3 of this Article.

• (a) supplementing this Regulation by laying down specific criteria and conditions for the performance of official controls conducted to ensure the traceability at all stages of production, preparation and distribution, and compliance with this Regulation, concerning:
• (i) checks of documentary accounts;
• (ii) controls performed on specific categories of operators;
• (iii) where appropriate, the period within which the controls provided for in this Regulation, including the physical on-the-spot inspections referred to in paragraph 3 of this Article, are to be performed and the particular premises in or area on which they are to be performed;

• (b) amending paragraph 2 of this Article by adding further elements based on practical experience, or by amending those added elements.

• (a) the minimum percentage of all official controls of operators or groups of operators that are to be carried out without prior notice as referred to in point (a) of paragraph 4;

• (b) the minimum percentage of additional controls referred to in point (b) of paragraph 4;

• (c) the minimum number of samples referred to in point (c) of paragraph 4;

• (d) the minimum number of operators that are members of a group of operators referred to in point (d) of paragraph 4.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

Article 39

Additional rules on actions to be taken by the operators and groups of operators

• (a) keep records to demonstrate their compliance with this Regulation;

• (b) make all declarations and other communications that are necessary for official controls;

• (c) take relevant practical measures to ensure compliance with this Regulation;

• (d) provide, in form of a declaration to be signed and updated as necessary:
• (i) the full description of the organic or in-conversion production unit and of the activities to be performed in accordance with this Regulation;
• (ii) the relevant practical measures to be taken to ensure compliance with this Regulation;
• (iii) an undertaking:
• — to inform in writing and without undue delay buyers of the products and to exchange relevant information with the competent authority, or, where appropriate, 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,
• — to accept the transfer of the control file in the case of change of control authority or control body or, in the case of withdrawal from organic production, the keeping of the control file for at least five years by the last control authority or control body,
• — to immediately inform the competent authority or the authority or body designated in accordance with Article 34(4) in the event of withdrawal from organic production, and
• — to accept the exchange of information among those authorities or bodies in the event that subcontractors are subject to controls by different control authorities or control bodies.

• (a) the records for demonstrating compliance with this Regulation;

• (b) the declarations and other communications that are necessary for official controls;

• (c) the relevant practical measures for ensuring compliance with this Regulation.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

Article 40

Additional rules on the delegation of official control tasks and tasks related to other official activities

• (a) the delegation contains a detailed description of the delegated official control tasks and tasks related to other official activities, including reporting obligations and other specific obligations, and of the conditions under which the control body may carry them out. In particular, the control body shall have submitted the following to the competent authorities for prior approval:
• (i) its risk assessment procedure, which is to determine, in particular, the basis for the intensity and frequency of the verification of compliance of the operators and groups of operators, which is to be established on the basis of the elements referred to in Article 9 of Regulation (EU) 2017/625 and of Article 38 of this Regulation, and which is to be followed for official controls on operators and groups of operators;
• (ii) the standard control procedure, which is to contain a detailed description of the control measures that the control body undertakes to apply to the operators and groups of operators that are subject to its controls;
• (iii) a list of measures that are in conformity with the common catalogue referred to in Article 41(4), and that are to be applied to operators and groups of operators in cases of suspected or established non-compliance;
• (iv) the arrangements for the effective monitoring of the official control tasks and tasks related to other official activities carried out in relation to operators and groups of operators and the arrangements for reporting on those tasks. The control body shall notify subsequent amendment of the elements referred to in points (i) to (iv) to the competent authority;

• (b) those competent authorities have procedures and arrangements in place to ensure the supervision of control bodies, including to verify that the delegated tasks are carried out effectively, independently and objectively, in particular as regards the intensity and frequency of the verification of compliance.

At least once a year, competent authorities shall, pursuant to point (a) of Article 33 of Regulation (EU) 2017/625, organise audits of the control bodies to whom they have delegated official control tasks or tasks related to other official activities.

• (a) the supervision and audit of other control authorities or control bodies;

• (b) the power to grant derogations other than derogations for the use of plant reproductive material not obtained from organic production;

• (c) the authority to receive notifications of activities by operators or groups of operators under Article 34(1) of this Regulation;

• (d) the assessment of the likelihood of non-compliance with the provisions of this Regulation that determine the frequency with which physical checks are to be performed on organic consignments prior to their release for free circulation into the Union in accordance with Article 54 of Regulation (EU) 2017/625;

• (e) the establishment of the common catalogue of measures referred to in Article 41(4) of this Regulation.

• (a) for a period that shall not exceed 12 months, during which the control body is to remedy the shortcomings identified during audits and inspections or to address the non-compliance about which information was shared with other control authorities and control bodies, with competent authorities as well as with the Commission in accordance with Article 43 of this Regulation; or

• (b) for the period during which the accreditation referred to in point (b)(iv) of Article 29 of Regulation (EU) 2017/625, in connection with Article 40(3) of this Regulation, is suspended.

Where the delegation of official control tasks or tasks related to other official activities has been suspended, the control bodies concerned shall not issue certificates referred to in Article 35 for those parts for which the delegation has been suspended. Competent authorities shall decide whether any certificates issued by the control bodies concerned before the date of that partial or full suspension are to remain valid, and shall inform the operators concerned of that decision.

Without prejudice to Article 33 of Regulation (EU) 2017/625, the competent authorities shall lift the suspension of the delegation of official control tasks or tasks related to other official activities as soon as possible once the control body has remedied the shortcomings or non-compliances referred to in point (a) of the first subparagraph or once the accreditation body has lifted the suspension of the accreditation referred to in point (b) of the first subparagraph.

• (a) a list of the operators which were subject to their controls on 31 December of the previous year by 31 January of each year; and

• (b) information on the official controls and other official activities carried out in the previous year to support the preparation of the part on organic production and labelling of organic products of the annual report referred to in Article 113 of Regulation (EU) 2017/625 by 31 March of each year.

Article 41

Additional rules on actions in the event of suspected and established non-compliance, and common catalogue of measures

• (a) it shall immediately carry out an official investigation in accordance with Regulation (EU) 2017/625 with a view to verifying compliance with this 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 provisionally prohibit both the placing on the market of the products concerned as organic or in-conversion products and their use in organic production pending the results of the investigation referred to in point (a). Before taking such a decision, the competent authority, or, where appropriate, the control authority or control body, shall give the operator an opportunity to comment.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

Article 42

Additional rules on measures in the event of non-compliance affecting integrity

Article 43

Additional rules on the exchange of information

Competent authorities shall share that information with other competent authorities and the Commission via a computer system that enables the electronic exchanges of documents and information made available by the Commission.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

CHAPTER VII TRADE WITH THIRD COUNTRIES

Article 44

Export of organic products

Article 45

Import of organic and in-conversion products

• (a) the product is a product as referred to in Article 2(1);

• (b) one of the following applies:
• (i) the product complies with Chapters II, III and IV of this Regulation, and all operators and groups of operators referred to in Article 36, including exporters in the third country concerned, have been subject to controls by control authorities or control bodies recognised in accordance with Article 46, and those authorities or bodies have provided all such operators, groups of operators and exporters with a certificate confirming that they comply with this Regulation;
• (ii) in cases where the product comes from a third country which is recognised in accordance with Article 47, that product complies with the conditions laid down in the relevant trade agreement; or
• (iii) in cases where the product comes from a third country which is recognised in accordance with Article 48, that product complies with the equivalent production and control rules of that third country and is imported with a certificate of inspection confirming this compliance that was issued by the competent authorities, control authorities or control bodies of that third country; and

• (c) the operators in third countries are able at any time to provide the importers and the national authorities in the Union and in those third countries with information allowing the identification of the operators that are their suppliers and the control authorities or control bodies of those suppliers, with a view to ensuring the traceability of the organic or in-conversion product concerned. That information shall also be made available to the control authorities or control bodies of the importers.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

Article 46

Recognition of control authorities and control bodies

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 55(2).

• (a) they are legally established in one Member State or third country;

• (b) they have the capacity to carry out controls to ensure that the conditions set out in points (a), (b)(i) and (c) of Article 45(1) and in this Article are met in relation to organic products and in-conversion products intended for import into the Union, without delegating control tasks; for the purposes of this point, control tasks carried out by persons working under an individual contract or a formal agreement that place them under the management control and the procedures of the contracting control authorities or control bodies shall not be considered as delegation, and the prohibition to delegate control tasks shall not apply to sampling;

• (c) they offer adequate guarantees of objectivity and impartiality and are free from any conflict of interest as regards the exercise of their control tasks; in particular, they have procedures in place ensuring that the staff performing controls and other actions is free from any conflict of interest, and that the operators are not inspected by the same inspectors for more than 3 years consecutively;

• (d) in the case of control bodies, they are accredited for the purpose of their recognition in accordance with this Regulation by only one accreditation body under the relevant harmonised standard for ‘Conformity assessment – Requirements for bodies certifying products, processes and services’, the reference of which has been published in the Official Journal of the European Union;

• (e) they have the expertise, equipment and infrastructure required to carry out control tasks, and have a sufficient number of suitable qualified and experienced staff;

• (f) they have the capacity and the competency to carry out their certification and control activities in accordance with the requirements of this Regulation and in particular Commission Delegated Regulation (EU) 2021/1698 ([^E0025]) for each type of operator (single operator or group of operators) in each third country and for each category of products they want to be recognised for;

• (g) they have procedures and arrangements in place to ensure the impartiality, the quality, the consistency, the effectiveness and the appropriateness of controls and other actions performed by them;

• (h) they have sufficient qualified and experienced staff so that controls and other actions can be performed effectively and in due time;

• (i) they have appropriate and properly maintained facilities and equipment to ensure that staff can perform controls and other actions effectively and in due time;

• (j) they have procedures in place in order to ensure that their staff have access to the premises of, and documents kept by operators so as to be able to accomplish their tasks;

• (k) they have internal skills, training and procedures suitable to perform effective controls, including inspections, on operators as well as on the internal control system of a group of operators, if any;