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2021-05-28
ProductIP
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Test plan for polymeric Food Contact Materials

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

What kind of laboratory analysis respectively tests are required for plastic, rubber or silicone Food Contact Materials (FCM) and articles?

Before answering this question you must know what polymeric materials are. This is explained in compliance clip Polymeric food contact materials

If your product complies with the PIM regulation or with the Council of Europe (CoE) resolution for silicone FCMs or with the CoE resolution for rubbers , i.e. you know the "compounding formulation" of the plastic, silicone or rubber and the monomers used to make the polymers in the plastic or silicone or rubber compound, you can already check whether you are compliant with all applicable European chemical legislation.  So POP, REACH annex XVII and SVHCs are not an issue in terms of testing (document control).

For most products originating in South-East Asia, I think it is an illusion to be able to find out this kind of data in detail.

What should be achievable for you as concerned and responsible importer or brand owner is to get "Food Grade Declarations" (these are not DoCs) of the ingredients of the compounding formulation(s) used. With this data you can have an SGS, TuV, Eurofins, QIMA, Intertek, BV etc. carry out the correct and complete test protocol.

A food grade declaration states that there are only substances in the compound that are listed in positive lists (union PIM list, positive CoE list for making silicones etc.). including the named substances for which a restriction applies.

See screenshot of a random example of a Food Grade Declaration of a PP compound which can be used for i.e.  making components for food processors or coffee makers by injection moulding.

This text in the food grade declaration states that this PP compound only contains substances that are on the positive list of the PIM. Additives and monomers for which there are no restrictions do not need to be mentioned.  This avoids having to deal with "confidential" excuses or accept any other "nonsense" stories from your manufacturers/suppliers.

Only substances for which restrictions apply (necessary for the test plan/protocol) are listed.

The complete example of the food grade declaration is here (pdf).

What are the obligations for manufactures who are making Food Contact Articles for the Chinese market?

Chinese equivalent FCM legislation is in a great extend similar to the European FCM legislation.
The Chinese equivalent for the European framework regulation for Food Contact Materials  (EC) 1935/2004 is GB 9685-2016.

GB 9685 includes definition, general rules and several appendixes. The appendixes are the most important parts. The use of additives in food contact materials and their articles shall simultaneously meet the requirements of Appendixes A, B and C in GB 9685. 

  • Appendix A: list of permitted additives and use conditions, grouped by the type of food contact materials (from A1 to A7);
  • Appendix B: requirements on total specific migration limit;
  • Appendix C: special limitation of metallic elements.

Appendix A includes 7 tables. 

  • A1: permitted additives for plastic food contact materials and articles
  • A2: permitted additives for paints and coatings for food contact use
  • A3: permitted additives for rubber food contact materials and articles
  • A4: permitted additives for printing inks for food contact use
  • A5: permitted additives for adhesives for food contact use
  • A6: permitted additives for paper and board for food contact use
  • A7: permitted additives for other materials such as silicon rubber.

For each additive, its name, CAS no., use scope, maximum use level, specific migration limit (SML) or maximum residue (QM) and other requirements are given.

In other words, if Chinese manufacturers place their products on the Chinese market, they must also have detailed data regarding plastic, rubber or silicone compounds. They must have documents such as Food Grade Declarations available.


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