(1) in Article 2, the following point (s) is added: "(s) "control file" means all the information and documents transmitted, for the purposes of the control system, to the competent authorities of the Member State or to control authorities and control bodies by an operator subject to the control system as referred to in Article 28 of Regulation (EC) No 834/2007, including all the relevant information and documents relating to that operator or the activities of that operator held by competent authorities, control authorities and control bodies, with the exception of information or documents that have no bearing on the operation of the control system.";
(2) in the first subparagraph of Article 63(2), the following points (d) to (h) are added: "(d) to accept, in cases where the operator and/or the subcontractors of that operator are checked by different control authorities or control bodies in accordance with the control system set up by Member State concerned, the exchange of information between those authorities or bodies; (e) to accept, in cases where the operator and/or the subcontractors of that operator change their control authority or control body, the transmission of their control files to the subsequent control authority or control body; (f) to accept, in cases where the operator withdraws from the control system, to inform without delay the relevant competent authority and control authority or control body; (g) to accept, in cases where the operator withdraws from the control system, that the control file is kept for a period of at least five years; (h) to accept to inform the relevant control authority or authorities or control body or bodies without delay of any irregularity or infringement affecting the organic status of their product or organic products received from other operators or subcontractors.";
(3) in Article 65, paragraph 2 is replaced by the following: "2. The control authority or control body shall take and analyse samples for detecting of products not authorised for organic production, for checking production techniques not in conformity with the organic production rules or for detecting possible contamination by products not authorised for organic production. The number of samples to be taken and analysed by the control authority or control body every year shall correspond to at least 5 % of the number of operators under its control. The selection of the operators where samples have to be taken shall be based on the general evaluation of the risk of non-compliance with the organic production rules. This general evaluation shall take into account all stages of production, preparation and distribution. The control authority or control body shall take and analyse samples in each case where the use of products or techniques not authorised for organic production is suspected. In such cases no minimum number of samples to be taken and analysed shall apply. Samples may also be taken and analysed by the control authority or control body in any other case for detecting of products not authorised for organic production, for checking production techniques not in conformity with the organic production rules or for detecting possible contamination by products not authorised for organic production."; (4) in Article 68(1), the following subparagraph is added: "In case of electronic certification as referred to in Article 29(3) of Regulation (EC) No 834/2007, the signature in box 8 of the documentary evidence shall not be required if the authenticity of the documentary evidence is otherwise shown by a tamper-proof electronic method."; (5) Articles 92 and 92a are replaced by the following: "Article 92 Exchange of information between control authorities, control bodies and competent authorities 1. Where the operator and/or the subcontractors of that operator are checked by different control authorities or control bodies, the control authorities or control bodies shall exchange the relevant information on the operations under their control. 2. Where operators and/or their subcontractors change their control authority or control body, the change shall be notified without delay to the competent authority by the control authorities or control bodies concerned. The previous control authority or control body shall hand over the relevant elements of the control file of the operator concerned and the reports referred to in the second subparagraph of Article 63(2) to the subsequent control authority or control body. The new control authority or control body shall ensure that non-conformities noted in the report of the previous control authority or control body have been or are being addressed by the operator. 3. Where the operator withdraws from the control system, the control authority or control body of that operator shall, without delay, inform the competent authority. 4. Where a control authority or control body finds irregularities or infringements affecting the organic status of products, it shall without delay inform the competent authority of the Member State which designated or approved it in accordance with Article 27 of Regulation (EC) No 834/2007. That competent authority may require, on its own initiative, also any other information on irregularities or infringements. In case of irregularities or infringements found with regard to products under the control of other control authorities or control bodies, it shall also inform those authorities or bodies without delay. 5. Member States shall take the appropriate measures and establish documented procedures to enable exchange of information between all control authorities they have designated and/or all control bodies they have approved in accordance with Article 27 of Regulation (EC) No 834/2007, including procedures for the exchange of information for the purpose of verifying documentary evidence referred to in Article 29(1) of that Regulation. 6. Member States shall take the appropriate measures and establish documented procedures in order to ensure that information on the results of inspections and visits as referred to in Article 65 of this Regulation is communicated to the paying agency in accordance with the needs of that paying agency as provided for in Article 33(1) of Commission Regulation (EU) No 65/2011 OJ L 25, 28.1.2011, p. 8 .Article 92a Exchange of information between different Member States and the Commission 1. Where a Member State finds irregularities or infringements relating to the application of this Regulation with regard to a product coming from another Member State and bearing indications as referred to in Title IV of Regulation (EC) No 834/2007 and in Title III and/or Annex XI to this Regulation, it shall notify the Member State which designated the control authority or approved the control body, the other Member States and the Commission without delay via the system referred to in Article 94(1) of this Regulation. 2. Where a Member State finds irregularities or infringements as regards compliance of the products imported in accordance with Article 33(2) or (3) of Regulation (EC) No 834/2007 with the requirements laid down in that Regulation or Regulation (EC) No 1235/2008, it shall notify the other Member States and the Commission without delay via the system referred to in Article 94(1) of this Regulation. 3. Where a Member State finds irregularities or infringements as regards compliance of the products imported in accordance with Article 19 of Regulation (EC) No 1235/2008 with the requirements laid down in that Regulation and Regulation (EC) No 834/2007, it shall notify the Member State which issued the authorisation, the other Member States and the Commission without delay via the system referred to in Article 94(1) of this Regulation. The notification shall be sent to the other Member States and to the Commission in case the irregularity or infringement is found with regard to products for which the Member State itself issued the authorisation referred to in Article 19 of Regulation (EC) No 1235/2008. 4. The Member State which receives a notification relating to non-compliant products in accordance with paragraph 1 or 3 or the Member State which issued the authorisation referred to in Article 19 of Regulation (EC) No 1235/2008 for a product for which an irregularity or infringement was found, shall investigate the origin of the irregularities or infringements. It shall take appropriate action immediately. It shall inform the Member State which sent the notification, the other Member States and the Commission of the result of the investigation and of the action taken by replying to the original notification via the system referred to in Article 94(1). The reply shall be sent within 30 calendar days from the date of the original notification. 5. The Member State which sent the original notification may ask the replying Member State for additional information, if needed. In any case, after receiving a reply or additional information from a notified Member State, the Member State which sent the original notification shall make the necessary entries and updates in the system referred to in Article 94(1). Article 92b Publication of information Member States shall make available to the public, in an appropriate manner including publication on the internet, the updated lists referred to in Article 28(5) of Regulation (EC) No 834/2007 containing updated documentary evidence related to each operator, as provided for in Article 29(1) of that Regulation and using the model set out in Annex XII to this Regulation. The Member States shall duly observe the requirements of the protection of personal data as laid down in Directive 95/46/EC of the European Parliament and of the Council OJ L 281, 23.11.1995, p. 31 .";----------------------OJ L 25, 28.1.2011, p. 8 .OJ L 281, 23.11.1995, p. 31 .";(6) in Title IV, the following Chapter 9 is added: " CHAPTER 9 Supervision by competent authorities Article 92c Supervisory activities relating to control bodies 1. The supervisory activities by competent authorities delegating control tasks to control bodies in accordance with Article 27(4)(b) of Regulation (EC) No 834/2007 shall focus on the evaluation of the operational performance of those control bodies, taking into account the results of the work of the national accreditation body as referred to in Article 2(11) of Regulation (EC) No 765/2008 of the European Parliament and of the Council OJ L 218, 13.8.2008, p. 30 .";Those supervisory activities shall include an assessment of the internal procedures of the control bodies for the controls, the management and examination of control files in the light of the obligations established by Regulation (EC) No 834/2007 and the verification of handling of non-conformities and the handling of appeals and complaints. 2. The competent authorities shall require control bodies to submit documentation on their risk analysis procedure. The risk analysis procedure shall be designed in such a way that: (a) the result of the risk analysis provides the basis for determining the intensity of the unannounced or announced annual inspections and visits; (b) additional random control visits carried out in accordance with Article 65(4) of at least 10 % of operators under contract in accordance with the risk category are performed; (c) at least 10 % of all inspections and visits carried out in accordance with Article 65(1) and (4) are unannounced; (d) the selection of operators to be submitted to unannounced inspections and visits is determined on the basis of the risk analysis and that these are planned according to the level of risk.
3. Competent authorities delegating control tasks to control bodies shall verify that the staff of the control bodies has sufficient knowledge, including knowledge of the risk elements affecting the organic status of products, qualifications, training and experience with respect to organic production in general and with the relevant Union rules in particular and that appropriate rules on rotation of inspectors are in force. 4. Competent authorities shall have documented procedures for the delegation of tasks to control bodies in accordance with Article 27(5) of Regulation (EC) No 834/2007 and for the supervision in accordance with this Article, detailing the information to be submitted by control bodies. Article 92d Catalogue of measures in case of irregularities and infringements Competent authorities shall adopt and communicate to control bodies that have been delegated control tasks, a catalogue at least listing infringements and irregularities affecting the organic status of products and corresponding measures to be applied by control bodies in case of infringements or irregularities by operators under their control who are involved in organic production. Competent authorities may include other relevant information in the catalogue on their own initiative. Article 92e Annual inspection of control bodies Competent authorities shall organise an annual inspection of the control bodies that have been delegated control tasks in accordance with Article 27(4)(b) of Regulation (EC) No 834/2007. For the purposes of the annual inspection, the competent authority shall take into account the results of the work of the national accreditation body as referred to in Article 2(11) of Regulation (EC) No 765/2008. During the annual inspection, the competent authority shall, in particular, verify: (a) the compliance with the control body’s standard control procedure as submitted by the control body to the competent authority in accordance with Article 27(6)(a) of Regulation (EC) No 834/2007; (b) that the control body has a sufficient number of suitable qualified and experienced staff in accordance with Article 27(5)(b) of Regulation (EC) No 834/2007 and that training concerning risks affecting the organic status of products has been implemented; (c) that the control body has and follows documented procedures and templates for: (i) the annual risk analysis in accordance with Article 27(3) of Regulation (EC) No 834/2007; (ii) preparing a risk-based sampling strategy, conducting sampling and laboratory analysis; (iii) information exchange with other control bodies and with the competent authority; (iv) initial and follow-up controls of operators under their control; (v) the application and follow-up to the catalogue of measures to be applied in case of infringements or irregularities; (vi) observing the requirements of the protection of personal data for the operators under its control as laid down by the Member States where that competent authority operates and in accordance with Directive 95/46/EC.
Article 92f Organic data in the multi-annual national control plan and annual report Member States shall ensure that their multi-annual national control plans referred to in Article 41 of Regulation (EC) No 882/2004 cover the supervision of controls performed on the organic production in accordance with this Regulation and to include the specific data on that supervision, hereinafter referred to as "the organic data", in the annual report referred to in Article 44 of Regulation (EC) No 882/2004. The organic data shall cover the topics listed in Annex XIIIb to this Regulation. The organic data shall be based on information on the controls performed by the control bodies and/or control authorities and on audits performed by the competent authority. The data shall be presented according to the templates provided for in Annex XIIIc to this Regulation as from 2015 for the year 2014. Member States may insert the organic data as an organic chapter of their national control plan and their annual report. ----------------------OJ L 218, 13.8.2008, p. 30 .";(7) Annexes XIIIb and XIIIc, the text of which is set out in the Annex to this Regulation, are inserted.
Commission Implementing Regulation (EU) No 392/2013 of 29 April 2013 amending Regulation (EC) No 889/2008 as regards the control system for organic production
which body is the competent authority resources available to the competent authority description of audits performed by the competent authority (how, by whom) documented procedure of the competent authority
system of control bodies and/or control authorities registered operators covered by the control system — minimum annual inspection how is the risk based approach applied
list of control bodies/authorities tasks delegated to the control bodies/conferred to control authorities supervision of delegated control bodies (by whom and how) coordination of activities in case of more than one control body/authority training of staff performing the controls announced/unannounced inspections and visits
| Report on official controls in the organic sector |
| Code number of control body or control authority | Number of registered operators per control body or control authority | Number of registered operators | Number of annual inspections | Number of additional risk based visits | Total number of inspections/visits | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Agricultural Producers | Aquaculture animal production units | Processors | Importers | Exporters | Other operators | Agricultural Producers | Aquaculture animal production units | Processors | Importers | Exporters | Other operators | Agricultural Producers | Aquaculture animal production units | Processors | Importers | Exporters | Other operators | Agricultural Producers | Aquaculture animal production units | Processors | Importers | Exporters | Other operators | ||
| MS-BIO-01 | |||||||||||||||||||||||||
| MS-BIO-02 | |||||||||||||||||||||||||
| MS-BIO-… | |||||||||||||||||||||||||
| Total | |||||||||||||||||||||||||
| Code number of control body or control authority or Name of Competent Authority | Number of registered operators | Number of samples analysed | Number of samples indicating breach of Regulations (EC) No 834/2007 and (EC) No 1235/2008 | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Agricultural Producers | Aquaculture animal production units | Processors | Importers | Exporters | Other operators | Agricultural Producers | Aquaculture animal production units | Processors | Importers | Exporters | Other operators | Agricultural Producers | Aquaculture animal production units | Processors | Importers | Exporters | Other operators | |
| MS-BIO-01 | ||||||||||||||||||
| MS-BIO-02 | ||||||||||||||||||
| MS-BIO-… | ||||||||||||||||||
| Total | ||||||||||||||||||
| Code number of control body or control authority | Number of registered operators | Number of irregularities or infringements found | Number of measures applied on the lot or the production run | Number of measures applied on the operator | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Agricultural Producers | Aquaculture animal production units | Processors | Importers | Exporters | Other operators | Agricultural Producers | Aquaculture animal production units | Processors | Importers | Exporters | Other operators | Agricultural Producers | Aquaculture animal production units | Processors | Importers | Exporters | Other operators | Agricultural Producers | Aquaculture animal production units | Processors | Importers | Exporters | Other operators | |
| MS-BIO-01 | ||||||||||||||||||||||||
| MS-BIO-02 | ||||||||||||||||||||||||
| MS-BIO-… | ||||||||||||||||||||||||
| Total | ||||||||||||||||||||||||
| Code number of control body or control authority | Number of registered operators per control body or control authority | Number of registered operators | Number of review audits | Number witness audits | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Agricultural Producers | Aquaculture animal production units | Processors | Importers | Exporters | Other operators | Agricultural Producers | Aquaculture animal production units | Processors | Importers | Exporters | Other operators | Agricultural Producers | Aquaculture animal production units | Processors | Importers | Exporters | Other operators | Agricultural Producers | Aquaculture animal production units | Processors | Importers | Exporters | Other operators | ||
| MS-BIO-01 | |||||||||||||||||||||||||
| MS-BIO-02 | |||||||||||||||||||||||||
| MS-BIO-… | |||||||||||||||||||||||||
| Total | |||||||||||||||||||||||||
| Code number of control body or control authority | Withdrawal of the approval | Actions taken to ensure effective operation of the control system for the organic production (enforcement) | ||
|---|---|---|---|---|
| Yes/No | ||||
| MS-BIO-01 | ||||
| MS-BIO-02 | ||||
| MS-BIO-… | ||||