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Commission Regulation (EC) No 1235/2008Show full title

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

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TITLE IU.K.INTRODUCTORY PROVISIONS

Article 1U.K.Subject matter

This Regulation lays down the detailed rules for the import of compliant products and the import of products providing equivalent guarantees as provided for in Articles 32 and 33 of Regulation (EC) No 834/2007.

Article 2U.K.Definitions

For the purposes of this Regulation:

1.

‘certificate of inspection’: means the certificate of inspection referred to in Article 33(1)(d) of Regulation (EC) No 834/2007 covering one consignment;

2.

‘documentary evidence’: means the document referred to in Article 68 of Commission Regulation (EC) No 889/2008(1) and in Article 6 of this Regulation, for which the model is set out in Annex II to this Regulation;

3.

‘consignment’: means a quantity of products under one or more Combined Nomenclature codes, covered by a single certificate of inspection, conveyed by the same means of transport and imported from the same third country;

4.

‘first consignee’: means the natural or legal person as defined in Article 2(d) of Regulation (EC) No 889/2008;

5.

‘[F1verification of the consignment’ means the verification carried out by the relevant Member State's competent authority, in the framework of the official controls provided for in Regulation (EC) No 882/2004 of the European Parliament and of the Council (2) , of the fulfilment of the requirements of Regulation (EC) No 834/2007, of Regulation (EC) No 889/2008 and of this Regulation through systematic documentary checks, random identity checks and, as appropriate according to its risk assessment, physical checks, prior to the release of the consignment for free circulation into the Union in accordance with Article 13 of this Regulation;

6.

‘ relevant Member State's competent authority ’ : means the customs authority, food safety authority or other authorities designated by the Member States pursuant to Article 27(1) of Regulation (EC) No 834/2007 responsible for the verification of the consignments and the endorsement of the certificates of inspection;]

7.

‘assessment report’: means the assessment report referred to in Articles 32(2) and 33(3) of Regulation (EC) No 834/2007 drawn up by an independent third party fulfilling the requirements of ISO Standard 17011 or by a relevant competent authority, which includes information on document reviews, including the descriptions referred to in Articles 4(3)(b) and 11(3)(b) of this Regulation, on office audits, including critical locations and on risk-oriented witness audits conducted in representative third countries[F1;]

8.

‘[F2aquaculture products’: means aquaculture products as defined in point 34 of Article 4(1) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council (3) ;

9.

‘unprocessed’: means unprocessed as used in the definition of unprocessed products in point (n) of Article 2(1) of Regulation (EC) No 852/2004 of the European Parliament and of the Council (4) , irrespective of packaging or labelling operations;

10.

‘ processed ’ : means processed as used in the definition of processed products in point (o) of Article 2(1) of Regulation (EC) No 852/2004, irrespective of packaging or labelling operations;

11.

‘ point of entry ’ : means the point of release for free circulation.]

Textual Amendments

TITLE IIU.K.IMPORT OF COMPLIANT PRODUCTS

CHAPTER 1U.K.List of recognised control bodies and control authorities for the purpose of compliance

Article 3U.K.Compilation and content of the list of recognised control bodies and control authorities for the purpose of compliance

1.The Commission shall draw up a list of control bodies and control authorities, recognised for the purpose of compliance in accordance with Article 32(2) of Regulation (EC) No 834/2007. The list shall be published in Annex I to this Regulation. The procedures for drawing up and amending the list are defined in Articles 4, 16 and 17 of this Regulation. The list shall be made available to the public on the Internet in accordance with Articles 16(4) and 17 of this Regulation.

2.The list shall contain all the information necessary in respect of each control body or control authority to allow verifying whether products placed on the Community market have been controlled by a control body or authority recognised in accordance with Article 32(2) of Regulation (EC) No 834/2007 and in particular:

(a)the name and address of the control body or control authority, including e-mail and Internet address and their code number;

(b)the third countries concerned and in which the products have their origin;

(c)the product categories concerned for each third country;

(d)the duration of the inclusion in the list;

(e)the Internet address where the list of operators subject to the control system can be found, including their certification status and the product categories concerned, as well as suspended and decertified operators and products.

Article 4U.K.Procedure for requesting inclusion in the list of recognised control bodies and control authorities for the purpose of compliance

[F11. The Commission shall consider whether to recognise and include a control body or control authority in the list provided for in Article 3 upon receipt of a request thereto from the representative of the control body or control authority concerned on the basis of the model of application made available by the Commission in accordance with Article 17(2). Only complete requests that have been received before [F331 October 2018] shall be taken into account for the drawing up of the first list.]

2.The request can be introduced by control bodies and control authorities established in the Community or in a third country.

3.The request shall consist of a technical dossier, which shall comprise all the information needed for the Commission to ensure that the conditions set out in Article 32(1) and (2) of Regulation (EC) No 834/2007 are met for all organic products intended for export to the Community, namely:

(a)an overview of the activities of the control body or control authority in the third country or third countries concerned, including an estimate of the number of operators involved and an indication of the expected nature and quantities of agricultural products and foodstuffs originated from the third country or third countries concerned and intended for export to the Community under the rules set out in Article 32(1) and (2) of Regulation (EC) No 834/2007;

(b)a detailed description of how Titles II, III and IV of Regulation (EC) No 834/2007 as well as the provisions of Regulation (EC) No 889/2008 have been implemented in the third country or in each of the third countries concerned;

(c)a copy of the assessment report as set out in the fourth subparagraph of Article 32(2) of Regulation (EC) No 834/2007:

(i)

proving that the control body or control authority has been satisfactorily assessed on its ability to meet the conditions set out in Article 32(1) and (2) of Regulation (EC) No 834/2007;

(ii)

giving guarantees on the elements referred to in Article 27(2), (3), (5), (6) and (12) of Regulation (EC) No 834/2007;

(iii)

ensuring that the control body or control authority meets the control requirements and precautionary measures set out in Title IV of Regulation (EC) No 889/2008; and

(iv)

confirming that it has effectively implemented its control activities according to these conditions and requirements;

(d)proof that the control body or authority has notified its activities to the authorities of the third country concerned and its undertaking to respect the legal requirements imposed on it by the authorities of the third country concerned;

(e)the website address where the list of operators subject to the control system can be found, as well as a contact point where information is readily available on their certification status, the product categories concerned, as well as suspended and decertified operators and products;

(f)an undertaking to comply with the provisions of Article 5 of this Regulation;

(g)any other information deemed relevant by the control body or control authority or by the Commission.

4.When examining a request for inclusion in the list of control body or control authority, and also any time after its inclusion, the Commission may request any further information, including the presentation of one or more on-the-spot examination reports established by independent experts. Furthermore, the Commission may, based on risk-assessment and in case of suspected irregularities, organise an on-the-spot examination by experts it designates.

5.The Commission shall assess whether the technical dossier referred to in paragraph 3 and the information referred to in paragraph 4 are satisfactory and may subsequently decide to recognise and include a control body or control authority in the list. The decision shall be taken in accordance with the procedure referred to in Article 37(2) of Regulation (EC) No 834/2007.

Textual Amendments

Article 5U.K.Management and review of the list of recognised control bodies and control authorities for the purpose of compliance

1.A control body or control authority may only be included in the list referred to in Article 3 when it fulfils the following obligations:

(a)if, after the control body or control authority has been included in the list, any changes are made to the measures applied by the control body or control authority, that control body or control authority shall notify the Commission thereof; requests to amend the information in respect of a control body or control authority referred to in Article 3(2) shall also be notified to the Commission;

(b)a control body or control authority included in the list shall keep available and communicate at first request all information related to its control activities in the third country; it shall give access to its offices and facilities to experts designated by the Commission;

(c)by 31 March every year, the control body or control authority shall send a concise annual report to the Commission; the annual report shall update the information of the technical dossier referred to in Article 4(3); it shall describe in particular the control activities carried out by the control body or control authority in the third countries during the previous year, the results obtained, the irregularities and infringements observed and the corrective measures taken; it shall furthermore contain the most recent assessment report or update of such report, which shall contain the results of the regular on-the-spot evaluation, surveillance and multiannual reassessment as referred to in Article 32(2) of Regulation (EC) No 834/2007; the Commission may request any other information deemed necessary;

(d)in the light of any information received, the Commission may at any time amend the specifications relating to the control body or control authority and may suspend the entry of that body or authority in the list referred to in Article 3; a similar decision may also be made where a control body or authority has not supplied information required or where it has not agreed to an on-the-spot examination;

(e)the control body or control authority shall make available to interested parties, on an Internet website, a continuously updated list of operators and products certified as organic.

2.If a control body or a control authority does not send the annual report, referred to in paragraph 1(c), does not keep available or does not communicate all information related to its technical dossier, control system or updated list of operators and products certified as organic, or does not agree to an on-the-spot examination, after request by the Commission within a period which the Commission shall determine according to the severity of the problem and which generally may not be less than 30 days, that control body or control authority may be withdrawn from the list of control bodies and control authorities, in accordance with the procedure referred to in Article 37(2) of Regulation (EC) No 834/2007.

If a control body or a control authority fails to take appropriate and timely remedial action, the Commission shall withdraw it from the list without delay.

CHAPTER 2U.K.Documentary evidence required for import of compliant products

Article 6U.K.Documentary evidence

1.The documentary evidence required for import of compliant products referred to in Article 32(1)(c) of Regulation (EC) No 834/2007, shall, in accordance with Article 17(2) of this Regulation, be established on the basis of the model set out in Annex II to this Regulation and contain at least all the elements that are part of that model.

2.The original documentary evidence shall be established by a control authority or the control body which has been recognised for issuing that documentary by a decision as referred to in Article 4.

3.The authority or body issuing the documentary evidence shall follow the rules established in accordance with Article 17(2) and in the model, notes and guidelines made available by the Commission via the computer system enabling electronic exchange of documents referred to in Article 17(1).

TITLE IIIU.K.IMPORT OF PRODUCTS PROVIDING EQUIVALENT GUARANTEES

CHAPTER 1U.K.List of recognised third countries

Article 7U.K.Compilation and content of the list of third countries

1.The Commission shall establish a list of recognised third countries in accordance with Article 33(2) of Regulation (EC) No 834/2007. The list of recognised countries is set out in Annex III to this Regulation. The procedures for drawing up and amending the list are defined in Articles 8 and 16 of this Regulation. Amendments to the list shall be made available to the public on the Internet in accordance with Articles 16(4) and 17 of this Regulation.

2.The list shall contain all the information necessary in respect of each third country to allow verifying whether products placed on the Community market have been subject to the control system of the third country recognised in accordance with Article 33(2) of Regulation (EC) No 834/2007 and in particular:

(a)the product categories concerned;

(b)the origin of the products;

(c)a reference to the production standards applied in the third country;

(d)the competent authority in the third country responsible for the control system, its address, including e-mail and Internet addresses;

[F1(e) the name, address, email address, internet address and code number of the control authority or authorities and the control body or bodies recognised by the competent authority referred to in point (d) to carry out controls;

(f) the name, address, email address, internet address and code number of the authority or authorities and the control body or bodies responsible in the third country for issuing certificates with a view to importing into the Union;]

(g)the duration of the inclusion in the list.

Textual Amendments

Article 8U.K.Procedure for requesting inclusion in the list of third countries

[F41. The Commission shall consider whether to include a third country in the list provided for in Article 7 upon receipt of a request for inclusion from the representative of the third country concerned, provided that such request is submitted before 1 July 2014 .]

2.The Commission shall only be required to consider a request for inclusion which meets the following preconditions.

The request for inclusion shall be completed by a technical dossier, which shall comprise all the information needed for the Commission to ensure that the conditions set out in Article 33(1) of Regulation (EC) No 834/2007 are met for products intended for export to the Community, namely:

(a)general information on the development of organic production in the third country, the products produced, the area in cultivation, the production regions, the number of producers, the food processing taking place;

(b)an indication of the expected nature and quantities of organic agricultural products and foodstuffs intended for export to the Community;

(c)the production standards applied in the third country as well as an assessment of their equivalence to the standards applied in the Community;

(d)the control system applied in the third country, including the monitoring and supervisory activities carried out by the competent authorities in the third country, as well as an assessment of its equivalent effectiveness when compared to the control system applied in the Community;

(e)the Internet or other address where the list of operators subject to the control system can be found, as well as a contact point where information is readily available on their certification status and the product categories concerned;

(f)the information the third country proposes to include in the list as referred to in Article 7;

(g)an undertaking to comply with the provisions of Article 9;

(h)any other information deemed relevant by the third country or by the Commission.

3.When examining a request for inclusion in the list of recognised third countries, and also any time after its inclusion, the Commission may request any further information, including the presentation of one or more on-the-spot examination reports established by independent experts. Furthermore, the Commission may, based on risk-assessment and in case of suspected irregularities organise an on-the-spot examination by experts it designates.

[F5Experts from other third countries recognised in accordance with Article 33(2) of Regulation (EC) No 834/2007 may be invited by the Commission to attend on-the-spot-examination as observers.]

[F64. The Commission shall assess whether the technical dossier referred to in paragraph 2 and the information referred to in paragraph 3 are satisfactory and may subsequently decide to recognise and include a third country in the list for a three-year period. Where the Commission considers that the conditions laid down in Regulation (EC) No 834/2007 and this Regulation continue to be met, it may decide to extend the inclusion of the third country after that three-year period.

The decisions referred to in the first subparagraph shall be taken in accordance with the procedure referred to in Article 37(2) of Regulation (EC) No 834/2007.]

Textual Amendments

Article 9U.K.Management and review of the list of third countries

1.The Commission shall only be required to consider a request for inclusion when the third country undertakes to accept the following conditions:

[F1(a) if, after a third country has been included in the list, any changes are made to the measures in force in the third country or their implementation and in particular to its control system, that third country shall notify the Commission thereof without delay; any changes made to the information referred to in points (d), (e) and (f) of Article 7(2) shall be notified to the Commission without delay via the computer system referred to in Article 94(1) of Regulation (EC) No 889/2008;]

(b)the annual report referred to in Article 33(2) of Regulation (EC) No 834/2007 shall update the information of the technical dossier referred to in Article 8(2) of this Regulation; it shall describe in particular the monitoring and supervisory activities carried out by the competent authority of the third country, the results obtained and the corrective measures taken;

(c)in the light of any information received, the Commission may at any time amend the specifications relating to the third country and may suspend the entry of that country from the list referred to in Article 7; a similar decision may also be made where a third country has not supplied information required or where it has not agreed to an on-the-spot examination.

2.If a third country does not send the annual report, referred to Article 33(2) of Regulation (EC) No 834/2007, does not keep available or does not communicate all information related to its technical dossier or control system or does not agree to an on-the-spot examination, after request by the Commission within a period which the Commission shall determine according to the severity of the problem and which generally may not be less than 30 days, that third country may be withdrawn from the list, in accordance with the procedure referred to in Article 37(2) of Regulation (EC) No 834/2007.

Textual Amendments

CHAPTER 2U.K.List of recognised control bodies and control authorities for the purpose of equivalence

Article 10U.K.Compilation and content of the list of recognised control bodies and control authorities for the purpose of equivalence

1.The Commission shall draw up a list of control bodies and control authorities, recognised for the purpose of equivalence in accordance with Article 33(3) of Regulation (EC) No 834/2007. The list shall be published in Annex IV to this Regulation. The procedures for drawing up and amending the list are defined in Articles 11, 16 and 17 of this Regulation. The list shall be made available to the public on the Internet in accordance with Articles 16(4) and 17 of this Regulation.

2.The list shall contain all the information necessary in respect of each control body or authority to allow verifying whether products placed on the Community market have been controlled by a control body or authority recognised in accordance with Article 33(3) of Regulation (EC) No 834/2007 and in particular:

(a)the name, address and code number of the control body or authority, and, when appropriate, its e-mail and Internet address;

(b)the third countries not listed in the list provided for in Article 7 where the products have their origin;

(c)the product categories concerned for each third country;

(d)the duration of the inclusion in the list;[F7 and]

[F8(e) the internet website where an updated list of operators subject to the control system can be found, indicating their certification status and the product categories concerned as well as a contact point where information is available on suspended and decertified operators and products [F8; and] ]

[F9(f) the internet website where a complete presentation of the production standard and control measures applied by the control body or control authority in a third country can be found.]

[F13. By way of derogation from paragraph 2(b), those products originating from a recognised third country listed in accordance with Article 7, but not covered by the recognition granted to that third country, may be included in the list provided for in this Article.]

Textual Amendments

Article 11U.K.Procedure for requesting inclusion in the list of recognised control bodies and control authorities for the purpose of equivalence

[F101. The Commission shall consider whether to include a control body or control authority in the list provided for in Article 10 upon receipt of a request thereto from the representative of the control body or control authority concerned on the basis of the model of application made available by the Commission in accordance with Article 17(2). Only complete requests that have been submitted by 30 June 2020 shall be taken into account for updating the list.]

2.The request can be introduced by control bodies and control authorities established in the Community or in a third country.

3.The request for inclusion shall consist of a technical dossier, which shall comprise all the information needed for the Commission to ensure that the conditions set out in Article 33(3) of Regulation (EC) No 834/2007 are met for products intended for export to the Community, namely:

(a)an overview of the activities of the control body or control authority in the third country or third countries, including an estimate of the number of operators involved and the expected nature and quantities of agricultural products and foodstuffs intended for export to the Community under the rules set out in Article 33(1) and (3) of Regulation (EC) No 834/2007;

(b)a description of the production standards and control measures applied in the third countries, including an assessment of the equivalence of these standards and measures with Titles III, IV and V of Regulation (EC) No 834/2007 as well as with the associated implementing rules laid down in Regulation (EC) No 889/2008;

(c)a copy of the assessment report as set out in the fourth subparagraph of Article 33(3) of Regulation (EC) No 834/2007:

(i)

proving that the control body or control authority has been satisfactorily assessed on its ability to meet the conditions set out in Article 33(1) and (3) of Regulation (EC) No 834/2007;

(ii)

confirming that it has effectively implemented its activities according to those conditions; and

(iii)

demonstrating and confirming the equivalence of the production standards and control measures referred to in subparagraph (b) of this paragraph;

(d)proof that the control body or control authority has notified its activities to the authorities of each of the third countries concerned and its undertaking to respect the legal requirements imposed on it by the authorities of each of the third countries concerned;

(e)the Internet website where the list of operators subject to the control system can be found, as well as a contact point where information is readily available on their certification status, the product categories concerned, as well as suspended and decertified operators and products;

(f)an undertaking to comply with the provisions of Article 12;

(g)any other information deemed relevant by the control body or control authority or by the Commission.

4.When examining a request for inclusion in the list of control body or control authority, and also any time after its inclusion, the Commission may request any further information, including the presentation of one or more on-the-spot examination reports established by independent expert. Furthermore, the Commission may organise an on-the-spot examination by experts it designates on a risk-based approach and in case of suspected irregularities.

5.The Commission shall assess whether the technical dossier referred to in paragraph 2 and the information referred to in paragraph 3 are satisfactory and may subsequently decide to recognise and include a control body or control authority in the list. The decision shall be taken in accordance with the procedure referred to in Article 37(2) of Regulation (EC) No 834/2007.

Textual Amendments

Article 12U.K.Management and review of the list of control bodies and control authorities for the purpose of equivalence

1.A control body or control authority may only be included in the list referred to in Article 10 when it fulfils the following obligations:

(a)if, after a control body or control authority has been included in the list, any changes are made to the measures applied by the control body or control authority, that control body or control authority shall notify the Commission thereof; requests to amend the information in respect of a control body or authority referred to in Article 10(2), shall also be notified to the Commission;

(b)by [F828 February] every year, the control body or control authority shall send a concise annual report to the Commission. The annual report shall update the information of the technical dossier referred to in Article 11(3); it shall describe in particular the control activities carried out by the control body or control authority in the third countries in the previous year, the results obtained, the irregularities and infringements observed and the corrective measures taken; It shall furthermore contain the most recent assessment report or update of such report, which shall contain the results of the regular on-the-spot evaluation, surveillance and multiannual reassessment as referred to in Article 33(3) of Regulation (EC) No 834/2007; the Commission may request any other information deemed necessary;

(c)in the light of any information received, the Commission may at any time amend the specifications relating to the control body or control authority and may suspend the entry of that body or authority from the list referred to in Article 10; a similar decision may also be made where a control body or control authority has not supplied information required or where it has not agreed to an on-the-spot examination;

(d)the control body or control authority shall make available to interested parties, by electronic means, a continuously updated list of operators, and of products certified as organic.

[F112. In accordance with the procedure referred to in Article 37(2) of Regulation (EC) No 834/2007 a control body or a control authority, or a reference to a specific product category or to a specific third country in relation to that control body or control authority, may be withdrawn from the list referred to in Article 10 of this Regulation in the following cases:

(a) if its annual report referred to paragraph 1(b) has not been received by the Commission by [F828 February] ;

(b) if it does not notify the Commission in due time of changes to its technical dossier;

(c) if it does not provide information to the Commission during the investigations of an irregularity case;

(d) if it fails to take adequate corrective measures in response to the irregularities and infringements observed;

(e) if it does not agree to an on-the-spot examination required by the Commission, or if an on-the-spot examination comes up with a negative result due to systematic malfunctioning of control measures;

(f) in any other situation presenting the risk for the consumer to be misled about the true nature of the products certified by the control body or the control authority.

If a control body or a control authority fails to take appropriate and timely remedial action after request by the Commission within a period which the Commission shall determine according to the severity of the problem and which generally may not be less than 30 days, the Commission shall withdraw it from the list without delay in accordance with the procedure referred to in Article 37(2) of Regulation (EC) No 834/2007. That withdrawal decision shall be published in the Official Journal of the European Union . The Commission shall make the amended list available as soon as possible to the public by any appropriate technical means, including publication on the Internet.]

Textual Amendments

CHAPTER 3U.K.Release for free circulation of products imported in accordance with Article 33 of Regulation (EC) No 834/2007

[F1Article 13 U.K. Certificate of inspection

1. The release for free circulation in the Union of a consignment of products referred to in Article 1(2) of Regulation (EC) No 834/2007 and imported in accordance with Article 33 of that Regulation shall be conditional on:

(a) the submission of an original certificate of inspection to the relevant Member State's competent authority;

(b) the verification of the consignment and the endorsement of the certificate of inspection by the relevant Member State's competent authority; and

(c) the indication of the number of the certificate of inspection in the customs declaration for release for free circulation as referred to in Article 158(1) of Regulation (EU) No 952/2013 of the European Parliament and of the Council (5) .

The verification of the consignment and the endorsement of the certificate of inspection shall be carried out by the relevant Member State's competent authority in that Member State where the consignment is released for free circulation in the Union.

Member States shall designate the points of entry in their territory and inform the Commission of the designated points of entry.

2. [F10The certificate of inspection shall be issued by the relevant control authority or control body before the consignment leaves the third country of export or origin. It shall be endorsed by the relevant Member State’s competent authority and completed by the first consignee on the basis of the model and the notes set out in Annex V and using the electronic Trade Control and Expert System (TRACES) established by Commission Decision 2003/24/EC (6) .]

[F12The original certificate of inspection shall be a printed and hand-signed copy of the completed electronic certificate in TRACES or, alternatively, a certificate of inspection signed in TRACES with a qualified electronic seal within the meaning of Article 3(27) of Regulation (EU) No 910/2014 of the European Parliament and of the Council (7) .]

When the original certificate of inspection is a printed and hand-signed copy of the completed electronic certificate in TRACES, control authorities, control bodies, relevant Member State's competent authorities and the first consignee shall verify at each stage of issuing, endorsement and reception of the certificate of inspection that this copy corresponds to the information indicated in TRACES. [F13In the absence in the printed hand-signed copy of the certificate of inspection of the information related to transport documents in boxes 16 and 17, and the relevant fields of box 13, or where such information is different than the one available in TRACES, relevant Member State’s competent authorities and the first consignee shall only consider for the purpose of verification and endorsement of the certificate of inspection the information available in TRACES.]

3. To be accepted for endorsement, the certificate of inspection shall have been issued by the control authority or control body of the producer or the processor of the product concerned or, where the operator carrying out the last operation for the purposes of preparation is different from the producer or processor of the product, by the control authority or control body of the operator carrying out the last operation for the purposes of preparation as defined in Article 2(i) of Regulation (EC) No 834/2007.

That control authority or control body shall be:

(a) a control authority or control body listed in Annex III to this Regulation for the products concerned and for the third country in which the products have their origin, or, where applicable, in which the last operation for the purposes of preparation has been carried out; or

(b) a control authority or control body listed in Annex IV to this Regulation for the products concerned and for the third country in which the products have their origin or in which the last operation for the purposes of preparation has been carried out.

4. [F14The control authority or control body issuing the certificate of inspection shall only issue the certificate of inspection and sign the declaration in box 18 of the certificate after it has carried out a documentary check on the basis of all relevant inspection documents, including in particular the production plan for the product concerned, commercial documents and, as appropriate according to its risk assessment, it has carried out a physical check of the consignment. The information related to transport documents in box 13, in particular number of packages and net weight, and the information in boxes 16 and 17 of the certificate of inspection concerning means of transport and transport documents shall be included in the certificate of inspection within maximum 10 days from the issuance of the certificate and, in any case, before endorsement of the certificate of inspection by the relevant Member State’s competent authorities.]

However, for processed products, if the control authority or control body issuing the certificate of inspection is a control authority or control body listed in Annex III, it shall only issue the certificate of inspection and sign the declaration in box 18 of the certificate after it has verified that all organic ingredients of the product have been controlled and certified by a control authority or control body recognised by the third country concerned listed in that Annex, or if the issuing control authority or control body is a control authority or control body listed in Annex IV, it shall only issue the certificate of inspection and sign the declaration in box 18 of the certificate after it has verified that all organic ingredients of such products have been controlled and certified by a control authority or control body listed in Annex III or IV or have been produced and certified in the Union in accordance with Regulation (EC) No 834/2007.

Where the operator carrying out the last operation for the purposes of preparation is different from the producer or processor of the product, the control authority or control body issuing the certificate of inspection and listed in Annex IV shall only issue the certificate of inspection and sign the declaration in box 18 of the certificate after it has carried out a documentary check on the basis of all relevant inspection documents, including transport documents and commercial documents, it has verified that the production or the processing of the product concerned has been controlled and certified by a control body or control authority recognised for the products concerned and the country concerned in accordance with Article 33(3) of Regulation (EC) No 834/2007 and it has carried out, as appropriate according to its risk assessment, a physical check of the consignment.

At the request of the Commission or of the competent authority of a Member State, the control authority or control body issuing the certificate of inspection in accordance with the second and third subparagraphs shall make available without delay the list of all operators in the organic production chain and the control authorities or control bodies under whose control those operators have placed their operations.

5. The certificate of inspection shall be made in one single original.

The first consignee or, where relevant, the importer may make a copy of the certificate of inspection for the purpose of informing the control authorities and control bodies in accordance with Article 83 of Regulation (EC) No 889/2008. Any such copy shall carry the indication ‘ COPY ’ printed or stamped thereon.

6. At the verification of a consignment, the relevant Member State's competent authority shall endorse the original certificate of inspection in box 20 and shall return it to the person who submitted the certificate.

7. The first consignee shall, at the reception of the consignment, complete box 21 of the certificate of inspection, to certify that the reception of the consignment has been carried out in accordance with Article 34 of Regulation (EC) No 889/2008.

The first consignee shall then send the original of the certificate to the importer mentioned in box 11 of the certificate for the purposes of the second subparagraph of Article 33(1) of Regulation (EC) No 834/2007.]

Textual Amendments

[F2Article 13a U.K. Force majeure or exceptional circumstances

1. In cases of force majeure or exceptional circumstances preventing the electronic system from working, and in particular of malfunctioning of the system or a lack of a lasting connection, certificates of inspection and their extracts may be issued and endorsed pursuant to Article 13(3) to (7) without using TRACES in accordance with paragraphs 2, 3 and 4 of this Article, and on the basis of the models and the notes set out in Annex V or VI. The competent authorities, control authorities, control bodies and operators shall inform the Commission without delay and shall insert in TRACES all the necessary details within ten calendar days following the re-establishment of the system.

2. When the certificate of inspection is issued without using TRACES, it shall be drawn up in one of the official languages of the Union and filled in, except for the stamps and signatures, either entirely in capital letters or entirely in typescript.

The certificate of inspection shall be in the official language or one of the official languages of the Member State of clearance. Where necessary, the relevant Member State's competent authorities may request a translation of the certificate of inspection into its official language or one of its official languages.

Uncertified alterations or erasures shall invalidate the certificate.

3. The control authority or control body issuing the certificate of inspection shall give a serial number to each issued certificate and keep a register of the issued certificates in chronological order and make the correspondence afterward with the serial number given by TRACES.

4. Where the certificate of inspection is issued and endorsed without using TRACES, the second and third subparagraphs of Article 15(1) and Article 15(5) shall not apply.

Textual Amendments

Article 13b U.K. Importer

The importer shall indicate the number of the certificate of inspection in the customs declaration for release for free circulation as referred to in Article 158(1) of Regulation (EU) No 952/2013.

Textual Amendments

Article 13c U.K. Access rights

The Commission shall be in charge of granting and updating access rights to TRACES of the competent authorities as defined in Article 2(n) of Regulation (EC) No 834/2007, of competent authorities of third countries recognised in accordance with Article 33(2) of that Regulation and of control authorities and control bodies listed in Annex III or IV to this Regulation. Before granting access rights to TRACES, the Commission shall verify the identity of the competent authorities, control authorities and control bodies concerned.

The competent authorities as defined in Article 2(n) of Regulation (EC) No 834/2007 shall be in charge of granting and updating access rights to TRACES of operators, control authorities and control bodies in the Union. Before granting access rights to TRACES, the competent authorities shall verify the identity of the operators, control authorities and control bodies concerned. Member States shall designate a single authority responsible to coordinate the cooperation and the contacts with the Commission in this area.

The competent authorities shall communicate the granted access rights to the Commission. The Commission shall activate those access rights in TRACES.

Textual Amendments

Article 13d U.K. Integrity and legibility of information

TRACES shall protect the integrity of the information encoded in accordance with this Regulation.

In particular, it shall offer the following guarantees:

(a)

it shall allow each user to be unequivocally identified and shall incorporate effective control measures of access rights in order to protect against illegal, malicious or unauthorised access, deletion, alteration or movement of the information, files and metadata;

(b)

it shall be equipped with physical protection systems against intrusions and environmental incidents and software protection against cyber-attacks;

(c)

it shall safeguard stored data in an environment which is secure in both physical and software terms;

(d)

it shall prevent, by various means, any unauthorised changes and incorporate integrity mechanisms to check if the information has been altered over time;

(e)

it shall keep an audit trail for each essential stage of the procedure;

(f)

it shall provide reliable format conversion and migration procedures in order to guarantee that the information is legible and accessible throughout the entire storage period required;

(g)

it shall have sufficiently detailed and up-to-date functional and technical documentation on the operation and characteristics of the system, that documentation being accessible at all times to the organisational entities responsible for the functional and/or technical specifications.]

Textual Amendments

Article 14U.K.Special customs procedures

[F11. Where a consignment coming from a third country is placed under customs warehousing or inward processing as provided for in Regulation (EU) No 952/2013, and subject to one or more preparations as referred to in the second subparagraph, the relevant Member State's competent authority shall carry out the verification of the consignment as referred to in point (b) of the first subparagraph of Article 13(1) of this Regulation before the first preparation is carried out. The reference number of the customs declaration by which the goods have been declared for customs warehousing or for inward processing procedure shall be indicated in box 19 of the certificate of inspection.

The preparation shall be limited to the following types of operations:

(a) packaging or repackaging; or

(b) labelling concerning the presentation of the organic production method.

After this preparation, the consignment shall be subject, before the release for free circulation, to the measures referred to in Article 13(1) of this Regulation.

After this procedure, the original of the certificate of inspection shall, where relevant, be returned to the importer of the consignment, referred to in box 11 of the certificate for the purposes of the second subparagraph of Article 33(1) of Regulation (EC) No 834/2007.]

2.Where, under a suspensive customs procedure pursuant to Regulation (EEC) No 2913/92, a consignment coming from a third country is intended to be submitted in a Member State, before its release for free circulation in the Community, to a splitting into different batches, the consignment shall be subject, before this splitting is carried out, to the measures referred to in Article 13(1) of this Regulation.

[F1For each of the batches which results from the splitting, the importer mentioned in box 11 of the certificate of inspection shall submit an extract of the certificate of inspection through TRACES to the relevant Member State's competent authority, in accordance with the model and the notes set out in Annex VI. After verification of the batch, the relevant Member State's competent authority shall endorse the extract of the certificate of inspection in box 13 for the purpose of the release for free circulation. The verification of the batch and the endorsement of the extract of the certificate of inspection shall be carried out by the relevant Member State's competent authority in that Member State where the batch is released for free circulation in the Union.]

A copy of each endorsed extract from the certificate of inspection shall be kept together with the original certificate of inspection by the person identified as the original importer of the consignment and mentioned in box 11 of the certificate of inspection. This copy shall carry the indication ‘COPY’ or ‘DUPLICATE’ printed or stamped thereon.

[ F15. . . . .]

[F16The consignee of a batch shall, at the reception thereof, complete the original of the extract of the certificate of inspection in box 14, in order to certify that the reception of the batch has been carried out in accordance with Article 34 of Regulation (EC) No 889/2008.]

The consignee of a batch shall keep the extract of the certificate of inspection at the disposal of the control authorities and/or control bodies for not less than two years.

3.The preparation and splitting operations referred to in paragraphs 1 and 2 shall be carried out in accordance with the relevant provisions set out in Title V of Regulation (EC) No 834/2007 and in Title IV of Regulation (EC) No 889/2008.

Textual Amendments

[F11Article 15 U.K. Non-compliant products

1. Without prejudice to any measures or actions taken in accordance with Article 30 of Regulation (EC) No 834/2007 and/or Regulation (EC) No 889/2008, the release for free circulation in the Union of products not in conformity with the requirements of Regulation (EC) No 834/2007 shall be conditional on the removal of references to organic production from the labelling, advertising and accompanying documents.

[F2When the verification of a consignment by a relevant Member State's competent authority leads to the detection of an infringement or an irregularity that leads to the refusal of the endorsement of the certificate and of the release for free circulation of products, that authority shall without delay notify that infringement or irregularity to the Commission and to the other Member States through TRACES.

Member States shall ensure effective and efficient coordination amongst competent authorities performing official controls with a view to exchanging without delay information on the detection of consignments of products referred to in Article 1(2) of Regulation (EC) No 834/2007 bearing terms referring to the organic production method, but not declared as intended to be imported in accordance with Regulation (EC) No 834/2007. The relevant Member State's competent authority shall without delay notify the Commission and the other Member States of those findings through TRACES.]

2. [F17Without prejudice to any measures or actions to be taken in accordance with Article 30 of Regulation (EC) No 834/2007, in case of suspicion of infringements and irregularities as regards compliance of imported organic products from third countries recognised in accordance with Article 33(2) of Regulation (EC) No 834/2007 or imported organic products controlled by control authorities or control bodies recognised in accordance with Article 33(3) of that Regulation with the requirements laid down in that Regulation, the importer shall take all necessary measures in accordance with Article 91(1) of Regulation (EC) No 889/2008.]

The importer and the control authority or control body which issued the certificate of inspection as referred to in Article 13 of this Regulation shall immediately inform the control bodies, control authorities and competent authorities of the Member States concerned and of the third countries involved in the organic production of the products in question and, where appropriate, the Commission. The control authority or control body may require that the product cannot be placed on the market with indications referring to the organic production method until it is satisfied, by the information received from the operator or from other sources, that the doubt has been eliminated.

[F173. Without prejudice to any measures or actions to be taken in accordance with Article 30 of Regulation (EC) No 834/2007, where a control authority or control body of a Member State or a third country has a substantiated suspicion of an infringement or irregularity as regards compliance of imported organic products from third countries recognised in accordance with Article 33(2) of Regulation (EC) No 834/2007 or imported organic products controlled by control authorities or control bodies recognised in accordance with Article 33(3) of that Regulation with the requirements laid down in that Regulation, it shall take all necessary measures in accordance with Article 91(2) of Regulation (EC) No 889/2008 and shall immediately inform the control bodies, control authorities and competent authorities of the Member States concerned and of the third countries involved in the organic production of the products in question and the Commission.]

[F54. Where a competent authority of a third country recognised in accordance with Article 33(2) of Regulation (EC) No 834/2007 or a control authority or control body recognised in accordance with Article 33(3) of that Regulation is notified by the Commission after having received a communication from a Member State informing it of a substantiated suspicion of an infringement or irregularity as regards compliance of imported organic products with the requirements laid down in that Regulation or this Regulation, it shall investigate the origin of the suspected irregularity or infringement and shall inform the Commission and the Member State which sent the initial communication of the result of the investigation and of the action taken. That information shall be sent within 30 calendar days from the date of sending of the original notification by the Commission.

The Member State which sent the initial communication may ask the Commission to request additional information, if needed, which shall be sent to the Commission and to the Member State concerned. In any case, after receiving a reply or additional information, the Member State which sent the initial communication shall make the necessary entries and updates in the computer system referred to in Article 94(1) of Regulation (EC) No 889/2008.]

[F25. The importer, the first consignee or their control authority or control body shall send the information on infringements or irregularities as regards imported products to the competent authorities of the Member States concerned via the computer system referred to in Article 94(1) of Regulation (EC) No 889/2008 through TRACES.] ]

Textual Amendments

TITLE IVU.K.COMMON RULES

Article 16U.K.Assessment of the requests and publication of the lists

1.The Commission shall examine the requests received in accordance with Articles 4, 8 and 11 with the assistance of the Committee on organic production, referred to in Article 37(1) of Regulation (EC) No 834/2007 (hereafter called ‘the Committee’). For this purposes the Committee shall adopt specific internal rules of procedure.

In order to assist the Commission with the examination of the requests and with the management and review of the lists, the Commission shall set up an expert group consisting of governmental and private experts.

2.For each request received, and after appropriate consultation with Member States in accordance with the specific internal rules of procedure, the Commission shall nominate two Member States to act as co-reporters. The Commission shall divide the requests between the Member States proportionally with the number of votes of each Member State in the Committee on organic production. The co-reporting Member States shall examine the documentation and information as set out in Articles 4, 8 and 11 related to the request and shall draw up a report. For the management and review of the lists, they shall also examine the annual reports and any other information referred to in Articles 5, 9 and 12 related to the entries on the lists.

3.Taking into account the result of the examination by the co-reporting Member States, the Commission shall decide, in accordance with the procedure referred to in Article 37(2) of Regulation (EC) No 834/2007, on the recognition of third countries, control bodies or control authorities, their inclusion on the lists or any modification of the lists, including the attribution of a code number to those bodies and authorities. The decisions shall be published in the Official Journal of the European Union.

4.The Commission shall make the lists available to the public by any appropriate technical means, including publication on the Internet.

Article 17U.K.Communication

1.When transmitting documents or other information referred to in Articles 32 and 33 of Regulation (EC) No 834/2007 and in this Regulation to the Commission or the Member States, the competent authorities of third countries, the control authorities or the control bodies shall use electronic transmission. When specific electronic transmission systems are made available by the Commission or the Member States, they shall use these systems. The Commission and the Member States shall also use these systems to provide each other with concerned documents.

2.For the form and content of documents and information referred to in Articles 32 and 33 of Regulation (EC) No 834/2007 and in this Regulation, the Commission shall set out guidelines, models and questionnaires where appropriate and make them available in the computer system referred to in paragraph 1 of this Article. These guidelines, models and questionnaires shall be adapted and updated by the Commission, after having informed the Member States and the competent authorities of third countries, as well as the control authorities and control bodies recognised in accordance with this Regulation.

[F13. The computer system provided for in paragraph 1 shall be able to collect the requests, documents and information referred to in this Regulation where appropriate.]

4.The supporting documents referred to in Articles 32 and 33 of Regulation (EC) No 834/2007 and in this Regulation, in particular in Articles 4, 8 and 11, shall be kept by the competent authorities of third countries, the control authorities or the control bodies at the disposal of the Commission and the Member States for at least three years following the year in which the controls took place or the certificates of inspection and documentary evidence were delivered.

5.Where a document or procedure provided for in Articles 32 and 33 of Regulation (EC) No 834/2007 or in the detailed rules for its application requires the signature of an authorised person or the approval of a person at one or more of the stages of that procedure, the computer systems set up for the communication of those documents must make it possible to identify each person unambiguously and provide reasonable assurance that the contents of the documents, including as regards the stages of the procedure, cannot be altered, in accordance with Community legislation, and in particular with Commission Decision 2004/563/EC, Euratom.

Textual Amendments

TITLE VU.K.FINAL AND TRANSITIONAL RULES

Article 18U.K.Transitional rules on the list of third countries

Requests for inclusion from third countries submitted in accordance with Article 2 of Regulation (EC) No 345/2008 before the 1 January 2009 shall be treated as applications under Article 8 of this Regulation.

[F1The first list of recognised countries shall include Argentina, Australia, Costa Rica, India, Israel (8) , New Zealand and Switzerland. It shall not contain the code numbers referred to in Article 7(2)(f) of this Regulation. These code numbers shall be added before 1 July 2010 by updating the list in accordance with Article 17(2).]

Textual Amendments

F15Article 19U.K. [F15Transitional rules on equivalent import of products not originating in listed third countries]

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Textual Amendments

[F2Article 19a U.K. Transitional rules on the use of certificates of inspection not issued in TRACES

Until 19 October 2017 certificates of inspection as referred to in Article 13(1)(a) and their extracts as referred to in Article 14(2) may be issued and endorsed pursuant to Article 13(3) to (7) without using TRACES in accordance with Article 13a(1), (2) and (3) and on the basis of the models and the notes set out in Annex V or VI.]

Textual Amendments

Article 20U.K.Repeal

Regulations (EC) No 345/2008 and (EC) No 605/2008 are repealed.

References to the repealed Regulations shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex VII.

Article 21U.K.Entry into force

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

It shall apply as from 1 January 2009.

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

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