# Commission Implementing Regulation (EU) No 392/2013Show full title

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         

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# 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

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products                           and repealing Regulation (EEC) No 2092/91(1), and in particular Article 33(2) and (3) and Article 38(c) and (d) thereof,                        

Whereas:

(1)According to Article 28(1) of Regulation (EC) No 834/2007, operators who produce, prepare, store, place on the market, import                              or export products produced in compliance with the production rules laid down in that Regulation must submit their undertaking                              to the control system referred to in Article 27 of that Regulation. Detailed rules for the application of that control system                              are laid down in Title IV of Commission Regulation (EC) No 889/2008 of 5 September 2008 laying down detailed rules for the                              implementation of Council Regulation (EC) No 834/2007 on organic production and labelling of organic products with regard                              to organic production, labelling and control(2).

(2)Under that control system the operators must notify their undertaking to the competent authority, including information on                              the relevant control body, and sign a declaration that they perform according to the organic rules, including the acceptance                              of enforcement of measures in case of infringements and irregularities.

(3)Article 30(2) of Regulation (EC) No 834/2007 provides for the communication of information related to irregularities or infringements                              affecting the organic status of a product. To enhance efficiency, operators should inform their control authorities or control                              bodies of any irregularity or infringement affecting the organic status of their product including organic products they receive                              from other operators.

(4)In the light of the experience gained with the implementation of the control system and in the interest of the organic sector,                              it is appropriate to establish a minimum number of samples to be taken and analysed by control authorities or control bodies                              every year on the basis of the general evaluation of the risk of non-compliance with the organic production rules. Where the                              control authorities or control bodies has suspicion that products not authorised for organic production are used, they should                              take and analyse samples of the products concerned. In such cases no minimum number of samples should apply. Samples may also                              be taken and analysed by control authorities or control bodies in any other case for detecting non-compliance with the Union                              organic requirements.

(5)In the light of the experience gained with the implementation of the control system and in the interest of the organic sector,                              it is appropriate to provide for the transmission of the relevant information in cases where the operator or the subcontractors                              of that operator are checked by different control authorities or control bodies or where operators or their subcontractors                              change their control authority or control body. Adequate exchange of information and transmission of the control files of                              those operators should be possible in order to manage the control system, while observing the requirements of the protection                              of personal data as laid down in Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the                              protection of individuals with regard to the processing of personal data and on the free movement of such data(3). Operators should accept the transmission and exchange of their data and all information relating to their activities under                              the control system.

(6)In order to ensure the uniform application of the control system and to avoid ambiguities, a definition of the term ‘control                              file’ should be included in Regulation (EC) No 889/2008.

(7)Electronic certification is referred to in Article 29(3) of Regulation (EC) No 834/2007 in relation to the form of the documentary                              evidence. It is appropriate to clarify that in case of electronic certification, the signature of the documentary evidence                              is not required if the authenticity of the documentary evidence is otherwise shown by a tamper-proof electronic method.

(8)The experience has shown that clarification is needed as regards the exchange of information between Member States in cases                              where a Member State finds irregularities or infringements concerning compliance of the products imported in accordance with                              Article 33(2) and (3) of Regulation (EC) No 834/2007 or Article 19 of Commission Regulation (EC) No 1235/2008 of 8 December                              2008 laying down detailed rules for implementation of Council Regulation (EC) No 834/2007 as regards the arrangements for                              imports of organic products from third countries(4).

(9)In addition, it is appropriate to clarify the procedure relating to the exchange of information between Member States in cases                              of irregularities or infringements, taking into account the best practices established since 2009.

(10)In order to ensure the coherence with Article 33(1) of Commission Regulation (EU) No 65/2011 of 27 January 2011 laying down                              detailed rules for the implementation of Council Regulation (EC) No 1698/2005, as regards the implementation of control procedures                              as well as cross-compliance in respect of rural development support measures(5), it is important to clarify that Member States should ensure that sufficient information on the controls carried out is received                              by the paying agency where controls are not carried out by the paying agency.

(11)In accordance with Article 44(1)(a) of Regulation (EC) No 882/2004 of the European Parliament and of the Council(6) Member States are required to indicate in their annual report any amendment to their multi-annual national control plan to                              take account of, inter alia, new legislation. The Commission should have the necessary data and information on the supervision                              carried out by competent authorities of the Member States in relation to organic production. Therefore, Member States should                              be required to amend their national control plan in order to cover that supervision and to indicate those amendments and the                              relevant organic data in the annual report referred to in Article 44 of Regulation (EC) No 882/2004. Member States should                              be allowed to present those organic data as a separate chapter in the national control plan and in the annual report.

(12)In addition to obligations relating to controls set out in Regulation (EC) No 882/2004, Title V of Regulation (EC) No 834/2007                              and Regulation (EC) No 889/2008 set out more specific provisions on the controls in the organic sector. In case the competent                              authority delegates control tasks to control bodies, which are private entities, Regulation (EC) No 834/2007 sets out more                              detailed requirements and obligations each control body has to fulfil.

(13)The experience has shown that the specific provisions on controls of organic production need to be more detailed, particularly                              in order to strengthen the supervision of competent authorities over the control bodies that have been delegated control tasks.                              Those provisions should be included in the control system of the Member States set up in accordance with Article 27 of Regulation                              (EC) No 834/2007 as uniform minimum requirements.

(14)Competent authorities of the Member States should have documented procedures for delegating tasks to control bodies and supervising                              them in order to ensure that the regulatory requirements are respected.

(15)The exchange of information within Member States, among Member States, and between Member States and the Commission relating                              to the supervision carried out by competent authorities should be improved and uniform minimum requirements should be adopted.

(16)Regulation (EC) No 889/2008 should therefore be amended accordingly.

(17)For the efficiency of the control arrangements, the additional elements, as added by this Regulation, which are to be covered                              by the undertaking included in the declaration to be signed by the operator as referred to in Article 63(2) of Regulation                              (EC) No 889/2008, should also apply to operators who signed that declaration before the date of application of this Regulation.

(18)In order to ensure the smooth transition from the current control system to the amended system, this Regulation should apply                              from 1 January 2014.

(19)The measures provided for in this Regulation are in accordance with the opinion of the regulatory Committee on organic production,

HAS ADOPTED THIS REGULATION:

## Article 1U.K.Amendment of Regulation (EC) No 889/2008

Regulation (EC) No 889/2008 is amended as follows:

in Article 2, the following point (s) is added:

“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.’;                                    

in the first subparagraph of Article 63(2), the following points (d) to (h) are added:

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;                                    

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;                                    

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;                                    

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;                                    

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.’;                                    

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.’;                           

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.’;                           

Articles 92 and 92a are replaced by the following:

### ‘Article 92Exchange 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(7).                           

### Article 92aExchange 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 92bPublication 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(8).’;                           

in Title IV, the following Chapter 9 is added:

### *‘CHAPTER 9*U.K.***Supervision by competent authorities***

#### Article 92cSupervisory 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(9).                           

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 92dCatalogue 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 92eAnnual 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:                           

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;                                    

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;                                    

that the control body has and follows documented procedures and templates for:                                    

the annual risk analysis in accordance with Article 27(3) of Regulation (EC) No 834/2007;                                             

preparing a risk-based sampling strategy, conducting sampling and laboratory analysis;                                             

information exchange with other control bodies and with the competent authority;                                             

initial and follow-up controls of operators under their control;                                             

the application and follow-up to the catalogue of measures to be applied in case of infringements or irregularities;                                             

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 92fOrganic 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.’;                           

Annexes XIIIb and XIIIc, the text of which is set out in the Annex to this Regulation, are inserted.

## Article 2U.K.Transitional provision

Points (d) to (h) of the first subparagraph of Article 63(2) of Regulation (EC) No 889/2008 as added by point (2) of Article                     1 of this Regulation shall also apply to operators who signed the declaration referred to in Article 63(2) of Regulation (EC)                     No 889/2008 before the date of application of this Regulation.                  

## Article 3U.K.Entry into force and application

This Regulation shall enter into force on the seventh day following that of its publication in the *Official Journal of the European Union*.                  

It shall apply from 1 January 2014.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 29 April 2013.

*For the Commission*                            

*The President*                            

José Manuel Barroso                            

## ANNEXU.K.

### “ANNEX XIIIb**Topics to be covered by the national competent authority in the organic data referred to in Article 92f**

#### 1.Information on the competent authority for the organic productionU.K.

          -  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 

#### 2.Description of the control system for organic productionU.K.

          -  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 

#### 3.Information on control bodies/authoritiesU.K.

          -  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 

### ANNEX XIIIc**Templates for the organic data referred to under Article 92f**

#### 1)Information on controls of operators:U.K.

#### 2)Information on supervision and audits:U.K.

#### 3)Conclusions on the control system for the organic production:U.K.

Statement of overall performance of the control system for the organic production:”U.K.                  

1

OJ L 189, 20.7.2007, p. 1.                           

2

OJ L 250, 18.9.2008, p. 1.                           

3

OJ L 281, 23.11.1995, p. 31.                           

4

OJ L 334, 12.12.2008, p. 25.                           

5

OJ L 25, 28.1.2011, p. 8.                           

6

OJ L 165, 30.4.2004, p. 1.                           

7

OJ L 25, 28.1.2011, p. 8.                           

8

OJ L 281, 23.11.1995, p. 31.’;                           

9

OJ L 218, 13.8.2008, p. 30.’;