The European Directive 2002/72/EC commonly called “Plastic Directive” was published in the August 2002 and it was made to replace previous directive regarding monomers (the Commission Directive 90/128/EC).
This due to the monomers directive was frequently amended and the Commission decided to consolidate the monomers directive with its 7 amendments in a single text, the Plastic Directive.
The Plastic Directive establishes substantially:
- A complete POSITIVE LIST of monomers, additives and other starting substances that can be used in food plastics’production.
- OVERALL MIGRATION LIMIT that the finished article must be meet when tested with appropriate food simulantes realted to real use conditions.
Overall Migration Limit (OML) is fixed in 10 milligrams per square decimeter of the article (or 60 mg/Kg) in special cases such as closure devices but not only.
The Directive also specifies additional limitations for some specific substances listed in the positive list: SML (Specific Migration Limit) and QM (Maximum Quantity allowed). The first parameter, SML, is verified through specific test on solutions deriving from food simulantes contact test meanwhile QM must be checked through documentation evaluation (by FOOD GRADE DECLARATION).
Accordingly, all monomers intended for use in the production of food contact plastics must be listed on the Plastics Directive, and the final food contact article must meet the OML and any SMLs or QMs that have been established for substances used as components of the article.
Regarding additive list, it is actually not-complete and continously updated so unlisted additives may still be used, provided that their use is demonstrated to be safe and meets any relevant requirements under applicable national laws.
It’ s important to define that the Plastic Directive does not regards materials or articles constituted by two or more layers that does not consist exclusively of plastic, regardless of whether the layer in direct contact with food is exclusively plastic
In addition, we point out that the positive lists of monomers and additives currently are not intended to include polymerization aids, nor are they intended to include substances used only in the production of surface coatings, epoxy resins, adhesives and adhesion promoters, or printing inks. So these materials also are subject to the national laws of individual EU Member State.
Other EU directives are related to migration of the constituents of plastic materials and articles, vinyl chloride monomer and directive on the use of certain epoxy derivatives in food-contact materials.
What is Food Grade Declaration?
Food Grade Declaration is a document released from plastic raw material supplier stating that all monomers, additives and other starting substances used in the production of article/material belong to 2002/72/EC (and successive amendments) approved list. This declaration also must point out the eventual presence of monomers, additives or other sustances having specific limitations: SML or QM. This to allow to competent authority/laboratory to evaluate the respect of these limitations.
So, the steps to define a plastic articles in compliance with European Directive 2002/72/EC are:
- Evaluation of belonging of all additives, monomers, starting substances to European Directive 2002/72/EC
- Evaluation of eventual starting substances for wich additional limitations are fixed (SML or QM)
- Inspection and test about the compliance to established limitations (SML or QM)
- Test of Overall Migration on article in finished form