Sidwell Consulting and Analytical Services Limited

Principal John A. Sidwell BSc, CChem, FRSC
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FOOD CONTACT MATERIALS - EU COMPLIANCE DOCUMENTATION - JUNE 2009

 

The UK Food Standards Agency* and other National Authorities have clarified requirements and provided guidance on business documentation for food contact materials as initially detailed in Annex VII to the 4th amendment to Directive 2002/72/EC - Directive 2007/19/EC and now included in EU Regulation No.10, 2011 on Plastics  

 

* Guide to United Kingdom Legal Compliance and Good Practice for Business Documentation - Materials and Articles in contact with food  

  

The legal requirement for business documentation concerns the presence and use of that documentation up and down the manufacturing and supply chain prior to the point of retail sale. It is based on two sets of needs laid down in the European legislation: namely, Regulation (EC) No. 2023/2006 on good manufacturing practice and Regulation (EC) No. 1935/2004 on materials and articles in contact with food.

 

Supporting documentation, substantiating the declaration of compliance, should be kept available for possible viewing by enforcement authorities. Sometimes this supporting documentation is made available to customers at the discretion of the manufacturer and may be the subject of a confidentiality agreement.

 

Supporting documentation includes;

 

  • Information about up-stream processing stages/ pre-suppliers "Certificates of suitability", Formulations/Process Data/GMP Documentation

  • Test results including third party test results

  • Calculations

  • Certificates from third parties

  • Risk assessments

  • Worst case scenarios

 

For help with the preparation of Declaration of Compliance Statements, please either e-mail enquiries@sidwellconsulting.net or use the Contact Us form