FDA and EU certificates: what they mean for a bottle producer
What FDA and EU food-contact certificates for PET resin confirm, what the bottle producer remains responsible for and which documents to request from your supplier.
Food-grade PET is a raw material that, once processed, will be in direct contact with water, beverages and food. A producer of bottles and packaging therefore needs to be sure the material is safe and to be able to prove it with documents. Here is what lies behind FDA and EU certificates.
FDA: US requirements
The FDA is the US Food and Drug Administration. Requirements for materials that come into contact with food are set out in federal regulations (Title 21 of the Code of Federal Regulations, 21 CFR). FDA compliance means that the polymer's composition and intended use are permitted for food contact under the specified conditions.
EU: European Union requirements
In the EU, the framework Regulation (EC) No 1935/2004 covers materials in contact with food, and the specific Regulation (EU) No 10/2011 covers plastics. Together they restrict the list of permitted substances and set migration limits — how much of a substance may transfer from the material into food during testing under defined conditions. Compliance is confirmed by a declaration of compliance based on testing.
What this means for a bottle producer
FDA and EU certificates for the resin confirm that the PET itself is suitable for direct food contact. But the bottle producer is responsible for the finished bottle, so it is important to:
- follow the processing conditions in the TDS — overheating and poor drying degrade the material's properties;
- check that colourants, additives and other components are also approved for food contact;
- take into account the requirements of the country where the product is sold — national rules may call for their own tests or documents.
Which documents to request from your supplier
- copies of the food-contact certificates (FDA, EU) for the exact grade you are buying;
- the TDS — technical data for the grade and processing recommendations;
- a quality certificate and a certificate of analysis (CoA) for every lot;
- a certificate of origin for customs clearance.
Check that the grade name in the certificates matches the one in the contract and the CoA.
Wankai food-grade resins comply with FDA and EU requirements, and the plant has its own laboratory accredited to ISO/IEC 17025. The WKAI Asia representative office provides copies of the certificates and prepares the contract and shipping documents in Russian.
Request copies of the certificates together with a quotation.