(a)

points 3 to 6 are replaced by the following: ‘3. Initial inspection When the inspection arrangements are first implemented, the operator responsible must draw up: — a full description of the unit and/or premises and/or activity, — all the practical measures to be taken at the level of the unit and/or premises and/or activity to ensure compliance with this Regulation, and in particular with the requirements in this Annex, — 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. Where appropriate, those description and measures may be part of a quality system as set up by the operator. The description and measures concerned must be contained in a declaration, signed by the responsible operator. In addition, this declaration must include an undertaking by the operator: — to perform the operations in accordance with Articles 5, 6, 6a and, where relevant, Article 11 of this Regulation, and/or Regulation (EC) No 223/2003, — to accept, in the event of infringement or irregularities, the enforcement of the measures referred to in Article 9(9) of this Regulation and, where relevant, in Article 10(3) of this Regulation, and — to accept 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. This declaration must be verified by the inspection body or authority that issues a report identifying the possible deficiencies and non-compliances with the provisions of this Regulation. The operator must countersign this report and take the necessary corrective measures. 4. Communications The operator responsible must notify any change in the description or of the measures referred to in point 3 and in the initial inspection provisions foreseen in sections A, B, C, D and E of the Specific Provisions of this Annex to the inspection body or authority in due time. 5. Inspection visits The inspection body or authority must make a full physical inspection, at least once a year, of all operators. The inspection body or authority may take samples for testing of products not authorised under this Regulation or for checking production techniques not in conformity with this Regulation. Samples may also be taken and analysed for detecting possible contamination by unauthorised products. However, such analysis must be carried out where the use of unauthorised products is suspected. An inspection report must be drawn up after each visit, countersigned by the responsible person of the unit or his representative. Moreover, the inspection body or authority shall carry out random inspection visits, announced or not, based on a general evaluation of the risk of non-compliance with this Regulation and with Regulation (EC) No 223/2003, taking into account at least the results of previous inspections, the quantity of products concerned and the risk for exchange of products. 6. Documentary accounts Stock and financial records must be kept in the unit or premises, to enable the operator to identify and the inspection body or authority to verify: — the supplier and, where different, the seller, or the exporter of the products, — the nature and the quantities of products as referred to in Article 1 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, — the nature and the quantities of products as referred to in Article 1 held in storage at the premises, — the nature, the quantities and the consignees and, where different, the buyers, other than the final consumers, of any products as referred to in Article 1, which have left the unit or the first consignee's premises or storage facilities, — in case of operators who do not store or physically handle such products, the nature and the quantities of products as referred to in Article 1 bought and sold, and the suppliers, and where different, the sellers or the exporters and the buyers, and where different, the consignees. The documentary accounts must also comprise the results of the verification at reception of products and any other information required by the inspection body or authority for the purpose of proper inspection. The data in the accounts must be documented with appropriate justification documents. The accounts must demonstrate the balance between the input and the output.’;