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

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