Article 8 · Commission Regulation (EU) 2024/3190

Contents

Article 8Declaration of compliance and supporting documentation#

1.Business operators shall ensure that food contact materials and articles covered by this Regulation which are not yet in contact with food, as well as bisphenols and bisphenol derivatives intended to be used as monomers or other starting substances in the manufacture of those food contact materials and articles, are accompanied at all marketing stages other than the retail stage by a written declaration as referred to in Article 16(1) of Regulation (EC) No 1935/2004 stating that they comply with the rules applicable to them (‘declaration of compliance’).

2.The declaration of compliance shall contain the information laid down in Annex III.

3.Appropriate supporting documentation shall be available to demonstrate such compliance. That documentation shall be made available without delay to the competent authorities on their demand.

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Defined terms · 5

Show every defined term

bisphenol
means a substance consisting of two hydroxyphenyl functional groups linked by one bridging atom, in accordance with structure A laid down in Annex I and includes the salt form of the bisphenol.
bisphenol derivative
means a substance indicated by the general structure B laid down in Annex I, not including the salt form of a bisphenol;
final food contact articles
means products composed of one or more food contact materials and articles that fall within the scope of Article 1(2) of Regulation (EC) No 1935/2004, which are in their finished state for end use, without undergoing any further chemical, biological or physical processing or modification, except their further processing or modification for filling with food, in order for them to be used for single-use packaging, including the sealing process;
hazardous bisphenol or hazardous bisphenol derivative
means a bisphenol or a bisphenol derivative listed in Part 3 of Annex VI to Regulation (EC) No 1272/2008 due to its harmonised classification as category 1A or 1B ‘mutagenic’, ‘carcinogenic’, ‘toxic to reproduction’ or category 1 ‘endocrine disrupting’ for human health.
intermediate food contact materials
means materials that are intended to undergo further chemical, biological or physical processing or modification in order to become all or part of a final food contact article, other than the further processing or modification for filling with food, in order for them to be used for single-use packaging, including the sealing process;