Assurance of compliance within the production chain of food contact materials by good manufacturing practice and documentation – Part 2: Implementation by the compliance box; call for guidelines

EU legislation requires that compliance of food contact materials (FCMs) with Article 3 of the Framework regulation 1935/2004 be established by good manufacturing practice (GMP): compliance must be dealt with at all stages of the manufacturing supply chain, either concluding compliance regarding a given aspect or delegating specified work to later stages. If there is specific legislation in place, compliance declarations (CDs) are required at all stages of production. This paper proposes the compliance box (CB) to structure the compliance work and format the documentation: section (1) identifies the business operator, (2) specifies the product and its intended uses, (3) deals with the compliance of the substances used, (4) with specific migration limits (SMLs) and other substance-related restrictions, (5) with the overall migration limit (OML), (6) with the impurities, reaction products and other not intentionally added substances (NIAS), and (7) closes with the issue date and signature. At each production stage, the compliance work is documented in the format of a CB which remains in-house (supporting documentation, here called food contact documentation FCDoc). A CB with sections 3–6 being reduced to delegated compliance work and, if required, CDs accompanies the product (food contact declaration, FCDec). During the manufacturing process, CBs merge to the point where compliance work is concluded. For the implementation, guidelines are needed, e.g., on unclear conventions applied in the past, a threshold of control, the range of the manufacturing process encompassed, the types of justifications considered acceptable for stating compliance, and the estimation of exposure. The main difficulties are in the unintentionally added substances.