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How to prepare a declaration of compliance (DoC) for FCMs
This session will look at the content, template format and regulatory compliance requirements for a declaration of compliance / conformity (DoC) that must be used to support and demonstrate the compliance of FCMs and articles intended to be placed on the market for food contact applications.
Examples of different DoCs will be provided followed by comments and remarks on each of the provided examples, function of different geographical markets.
During this module, you will learn about:
Ioan ParaschivRegulatory Affairs Manager FCM and REACH, Knoell, Netherlands
- which countries/regions, in the above mentioned markets, require industry to provide a DoC for FCMs and articles;
- which type of FCM and articles require a DoC, function of the market of interest;
- what exactly the content of a DoC is, function of the market of interest;
- what things should not be mentioned in a DoC;
- when to claim confidentiality (that is to say confidential business information, CBI) in a DoC;
- what information must be provided in a DoC, function of its position in the supply chain;
- which additional documents are required to support a DoC;
- when and exactly what information should be provided, function of the market, upon an external audit carried out at your facility by a national inspector; and
- what the penalties are that a company could face where a DoC and its supporting documentation are incomplete and are therefore considered not compliant.