Commission Regulation (EC) No 450/2009 CHAPTER IV — DECLARATION OF COMPLIANCE AND DOCUMENTATION

Article 12–Article 13 · 2 articles

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Declaration of compliance

Article 12

1. At the marketing stages other than at the point of sale to the final consumer, active and intelligent materials and articles, whether or not they are in contact with food, or the components intended for the manufacturing of those materials and articles or the substances intended for the manufacturing of those components, shall be accompanied by a written declaration in accordance with Article 16 of Regulation (EC) No 1935/2004. 2. The declaration referred to in paragraph 1 shall be issued by the business operator and shall contain the information set out in Annex II.

Supporting documentation

Article 13

Appropriate documentation to demonstrate that the active and intelligent materials and articles and the components intended for the manufacturing of those materials and articles comply with the requirements of this Regulation shall be made available by the business operator to the national competent authorities on request. That documentation shall contain information on the suitability and effectiveness of the active or intelligent material or article, the conditions and results of testing or calculations or other analysis, and evidence on the safety or the reasoning demonstrating compliance.

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