Migration from packaging material and other contact materials is highly regulated by various European and National laws, regulations, resolutions, recommendations and guidance documents.
On 27th October 2004 the European Parliament and the Council adopted the framework regulation (EC) No 1935/2004 concerning materials and articles intended to come into contact with food. According to Article 3 (1) materials and articles, which come into contact with food shall be produced in compliance with good manufacturing practice (“GMP”) so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities, which could
a) endanger human health,
b) bring about an unacceptable change in the composition of the food, or
c) bring about a deterioration in the organoleptic characteristics thereof.
The good manufacturing practice is defined in Commission Regulation (EC) 2023/2006.
Article 5 of the framework regulation defines specific groups in ANNEX I, which the regulation covers: 1. Active and intelligent materials and articles; 2. Adhesives; 3. Ceramics; 4. Cork; 5. Rubbers; 6. Glass; 7. Ion-exchange resins; 8. Metals and alloys; 9. Paper and board; 10. Plastics; 11. Printing inks; 12. Regenerated cellulose; 13. Silicones; 14. Textiles; 15. Varnishes and coatings; 16. Waxes; 17. Wood. For these groups specific measures may be adopted. The specific measures shall contain e.g. a list of substances authorised for use in the manufacturing of materials and articles, certain migration limits and basic rules for checking compliance as well as labelling and traceability rules. In the case there is no specific measurement for a group mentioned above Member States may maintain or adopt national provisions provided they comply with the rules of the Treaty according to Art. 6 (see e.g. “Recommendations” of the German “Federal Institute for Risk Assessment”, BfR).
The best regulated group are plastic materials, which are covered by European Commission Regulation EU 10/2011. In this regulation several possibilities for compliance testing are given:
- Analysis of the overall migration at specific “OM”-conditions to check compliance of overall migration limit (OML);
- Analysis of specific migration of substances into food simulants at specific migration test conditions to check compliance for the substance specific migration limit (SML)
- Analysis of the residual content limit of a substance;
- Replacing specific migration tests by overall migration tests similar to specific migration test conditions;
- Assumption of 100% migration of the substance;
- Migration modelling applying generally recognized diffusion models based on scientific evidence.
For compliance testing FABES investigates the migration from food packaging into the packed product. Therefore so called food simulants are used, simple test media, which imitate food, like Ethanol 50% for dairy products. An investigation often contains overall migration tests, a screening for “NIAS” (not intentionally added substances) and, if necessary, specific migration of certain substances. “NIAS” are, according to EC 10/2011, “not intentionally added substances as e.g. impurities in the substances used or a reaction intermediate formed during the production process or a decomposition or reaction product. Further analysis or modelling depends on the structure of the sample, the sample matrix or the purpose of the investigation. The evaluation is based on the analysed migration results in accordance with positive lists (plastics: “Union list”), containing substances which partly may be used only under restrictions. If necessary from analysis or modelling results further risk assessment will be conducted, e.g. by means of the “TTC-concept” of EFSA.
The same procedure applies also to paper and board articles as well as to other contact packaging materials like cosmetic or pharmaceutical packaging. In any case it is crucial to know the “worst-case” conditions of contact in order to determine the adequate migration conditions.
FABES examines the above-mentioned materials in accordance with applying rules and regulations and provides certificates of conformity concerning the migration behaviour.
In the case a substance shall be listed in the Union list, FABES is able to perform all tests concerning migration and residual content determinations requested by the European “Note for Guidance”. In addition the complete dossier, which will be sent to the “European Food Safety Agency” (EFSA), can be compiled in close cooperation with you.
This is also true for substances used in the manufacture of all kinds of materials, which are in contact with drinking water. In this case the guidelines of Germany´s Federal Environment Agency, “Umweltbundesamt” (UBA), apply. FABES is able to provide UBA conform migration tests and mathematical estimations (modelling) for compliance checks and comprehensive dossiers in case that the investigated substance is not listed till now.
If a substance is part of a coating or paper and board material, then an equal dossier as mentioned above has to be sent to BfR.
For FDA approval a more differentiated process is executed. Depending on the issue a recipe verification, above described examination or extractions according to 21 CFR (“Code of Federal Regulation”) are performed. If substances, which are part of the recipe, are not listed under 21 CFR, then a comprehensive Food Contact Notification (FCN) concerning this substance, its use and analysis, migration and toxicological behaviour has to be provided for FDA. FDA will approve the use if possible.
Conformity checks which have to be done for other countries, like e.g. Switzerland or China, are comparable to European and/or FDA procedures.