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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
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1.When the control arrangements are first implemented, the operator shall draw up and subsequently maintain:
(a)a full description of the unit and/or premises and/or activity;
(b)all the practical measures to be taken at the level of the unit and/or premises and/or activity to ensure compliance with the organic production rules;
(c)the precautionary measures to be taken in order to reduce the risk of contamination by unauthorised products or substances and the cleaning measures to be taken in storage places and throughout the operator's production chain[F1;]
[F2(d) the specific characteristics of the production method used, where the operator intends to request documentary evidence in accordance with Article 68(2).]
Where appropriate, the description and measures provided for in the first subparagraph may be part of a quality system as set up by the operator.
2.The description and the measures referred to in paragraph 1 shall be contained in a declaration, signed by the responsible operator. In addition, this declaration shall include an undertaking by the operator:
(a)to perform the operations in accordance with the organic production rules;
(b)to accept, in the event of infringement or irregularities, the enforcement of the measures of the organic production rules;
(c)to undertake to inform in writing the buyers of the product in order to ensure that the indications referring to the organic production method are removed from this production[F3;]
[F4(d)to accept, in cases where the operator and/or the subcontractors of that operator are checked by different control authorities or control bodies F5..., the exchange of information between those authorities or bodies;
(e) to accept, in cases where the operator and/or the subcontractors of that operator change their control authority or control body, the transmission of their control files to the subsequent control authority or control body;
(f) to accept, in cases where the operator withdraws from the control system, to inform without delay the relevant competent authority and control authority or control body;
(g) to accept, in cases where the operator withdraws from the control system, that the control file is kept for a period of at least five years;
(h) to accept to inform the relevant control authority or authorities or control body or bodies without delay of any irregularity or infringement affecting the organic status of their product or organic products received from other operators or subcontractors.]
The declaration provided for in the first subparagraph shall be verified by the control body or control authority that issues a report identifying the possible deficiencies and non-compliances with the organic production rules. The operator shall countersign this report and take the necessary corrective measures.
3.For the application of Article 28(1) of Regulation (EC) No 834/2007 the operator shall notify the following information to the competent authority:
(a)Name and address of operator;
(b)Location of premises and, where appropriate, parcels (land register data) where operations are carried out;
(c)Nature of operations and products;
(d)Undertaking by the operator to carry out the operation in accordance with the provision laid down in Regulation (EC) No 834/2007 and this Regulation;
(e)In the case of an agricultural holding, the date on which the producer ceased to apply products not authorised for organic production on the parcels concerned;
(f)The name of the approved body to which the operator entrusted control of his undertaking, where [F6that body is approved in accordance with the control system].
Textual Amendments
F1Substituted by Commission Implementing Regulation (EU) No 126/2012 of 14 February 2012 amending Regulation (EC) No 889/2008 as regards documentary evidence and amending Regulation (EC) No 1235/2008 as regards the arrangements for imports of organic products from the United States of America (Text with EEA relevance).
F2Inserted by Commission Implementing Regulation (EU) No 126/2012 of 14 February 2012 amending Regulation (EC) No 889/2008 as regards documentary evidence and amending Regulation (EC) No 1235/2008 as regards the arrangements for imports of organic products from the United States of America (Text with EEA relevance).
F3Substituted by 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.
F4Inserted by 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.
F5Words in Art. 63(2)(d) omitted (31.12.2020) by virtue of The Organic Production and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/693), regs. 1(2), 3(39)(a); 2020 c. 1, Sch. 5 para. 1(1)
F6Words in Art. 63(3)(f) substituted (31.12.2020) by The Organic Production and Control (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/693), regs. 1(2), 3(39)(b); 2020 c. 1, Sch. 5 para. 1(1)
The operator responsible shall notify any change in the description or of the measures referred to in Article 63 and in the initial control arrangements set out in Articles 70, 74, 80, 82, 86 and 88 to the control authority or control body in due time.
1.The control authority or control body shall carry out at least once a year a physical inspection of all operators.
[F32. 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.]
3.A control report shall be drawn up after each visit, countersigned by the operator of the unit or his representative.
4.Moreover, the control authority or control body shall carry out random control visits, primarily unannounced, based on the general evaluation of the risk of non-compliance with the organic production rules, taking into account at least the results of previous controls, the quantity of products concerned and the risk for exchange of products.
Textual Amendments
1.Stock and financial records shall be kept in the unit or premises and shall enable the operator to identify and the control authority or control body to verify:
(a)the supplier and, where different, the seller, or the exporter of the products;
(b)the nature and the quantities of organic products delivered to the unit and, where relevant, of all materials bought and the use of such materials, and, where relevant, the composition of the compound feedingstuffs;
(c)the nature and the quantities of organic products held in storage at the premises;
(d)the nature, the quantities and the consignees and, where different, the buyers, other than the final consumers, of any products which have left the unit or the first consignee's premises or storage facilities;
(e)in case of operators who do not store or physically handle such organic products, the nature and the quantities of organic products bought and sold, and the suppliers, and where different, the sellers or the exporters and the buyers, and where different, the consignees.
2.The documentary accounts shall also comprise the results of the verification at reception of organic products and any other information required by the control authority or control body for the purpose of proper control. The data in the accounts shall be documented with appropriate justification documents. The accounts shall demonstrate the balance between the input and the output.
3.Where an operator runs several production units in the same area, the units for non organic products, together with storage premises for input products must also be subject to the minimum control requirements.
1.The operator shall:
(a)give the control authority or control body, for control purposes, access to all parts of the unit and all premises, as well as to the accounts and relevant supporting documents;
(b)provide the control authority or control body with any information reasonably necessary for the purposes of the control;
(c)submit, when requested by the control authority or control body, the results of its own quality assurance programmes.
2.In addition to the requirements set out in paragraph 1, importers and first consignees shall submit the information on imported consignments referred to in Article 84.
1. For the purpose of the application of Article 29(1) of Regulation (EC) No 834/2007 the control authorities and control bodies shall use the model of the documentary evidence set out in Annex XII to this Regulation.
[F4In 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.]
2. If an operator subject to the controls of the control authorities and control bodies as referred to in paragraph 1 so requests within a time period to be indicated by those control authorities and control bodies, the control authorities and control bodies shall provide complementary documentary evidence confirming the specific characteristics of the production method used by means of the model set out in Annex XIIa.
Applications for complementary documentary evidence shall contain in box 2 of the model set out in Annex XIIa the relevant entry listed in Annex XIIb.]
Textual Amendments
F1Substituted by Commission Implementing Regulation (EU) No 126/2012 of 14 February 2012 amending Regulation (EC) No 889/2008 as regards documentary evidence and amending Regulation (EC) No 1235/2008 as regards the arrangements for imports of organic products from the United States of America (Text with EEA relevance).
For the purpose of the application of Article 9(3) of Regulation (EC) No 834/2007 the vendor declaration that products supplied have not been produced from or by GMOs may follow the model set out in Annex XIII to this Regulation.
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