Food Contact Materials Declaration of Compliance Inquiry - (EC) 1935/2004


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Hello Elsmar Cove Members,

I'm hoping someone can help me. We are a Canadian manufacturer of Aerospace and Automotive fasteners. About a week ago I had a Customer request for a declaration of Compliance to the European standard (EC) 1935/2004 Food Contact Materials. I was able to find the standard online and have been reading through it but I am not sure how to begin the process of compliance. Has anyone else had any requests of this nature? Any ideas about how to begin this process and determine if our fastener is safe for use in the food industry would be greatly appreciated. Thank you.


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Well just to let everyone know the Customer has determined the fastener probably isn't compliant and is no longer requesting this of us. No longer a requirement but would still be interested in knowing how one would go about complying. Thank you anyways!

the review process in preparation of declaring compliance is quite generic: pull up the publicly available regulation, walk through the requirements sections and compare your documented evidence against the requirements. In case you identify gaps, you will have to address them; in case of no gaps you will be ready to issue the declaration.



A note: (EC) 1935/2004 is a regulation, i.e. law in the European Union and not a standard


A question.
A customer is requesting Declaration of Compliance to EC 1935/2004 for stainless steel that we supply to him.
My stainless mill is not familiar with this - I am a distributor. First time I've gotten this request.
Is stainless steel GRAS? (generally regarded as safe)

As stated by Gerhard above, Directives are the law. Directives are standardized into 4 parts. Essential safety Equipment's, ESR, etc.
Long story short, everything has to be "harmonized" in the EU. Go to EU. Europa on the web. Look for harmonized standards. Basically the EU has created there own little ISO world, the European Norm, the EN and if you want to do business in the EU you have to prove you are equivalent to their EN standard. The EU doesn't recognize ASME, so for ASME B&PVC Sec 8 you would look under the harmonized standards and you would find EN 13445 section 2. For metals traceability in the EU, request EN 10204:2004 - 3.1 certificate. For the question regarding screws and GRAS. It would be Direct Food Contact, Indirect Food Contact or GRAS, Generally Recognized as Safe. If your screw is in contact with food or contributes to the food stream indirectly it would be applicable, but your SS should not be safe due to the chromium levels inherent in the stainless. I'll attach some information to help this make sense.


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