Introduction to European Regulations
Within the EU, FCM are assessed by the European Food Safety Authority (EFSA) but there is no single regulation covering all FCM. The EU does have a harmonized legal EU framework, Regulation (EC) No 1935/2004, which sets out the general principles of good manufacturing practice (GMP), safety and inertness for FCM, but it is not the whole story. Different forms of FCM are also covered by their own harmonized regulations, for example:
- Ceramics: Directive 84/500/EEC, amended by Directive 2005/31/EC
- Regenerated cellulose film: Directive 2007/42/EC
- Plastics: Regulation (EU) No 10/2011 and its amendments
- N-Nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers: Directive 93/11/EEC
- Epoxy derivatives: BADGE (2,2-Bis(4-hydroxyphenyl) propane bis(2,3-epoxypropyl) ether), BFDGE (Bis (hydroxyphenyl)methane bis(2,3-epoxypropyl) ethers) and NOGE (Novolac glycidyl ethers) in certain epoxy derivatives: Regulation (EC) No 1895/2005
Introduction to Council of Europe Resolutions
Despite efforts to further strengthen harmonized regulations on FCM there are many important materials including paper and board, glass, wood, cork, metals and alloys, textiles, adhesives, ion-exchange resins, printing inks, silicones, varnishes and coatings, and wax which do not have specific requirements at the EU level.
The Council of Europe developed some resolutions to close this gap. While the resolutions are not legally binding they are widely accepted as guidance documents in the absence of EU or national legislation by member states. These resolutions cover plastic colorants, polymerization aids, coatings, silicones, paper and board, cork, metals and alloys, ion-exchange resins, rubber and packaging inks.
|Food Contact Material||Citation|
|Coatings||Resolution ResAP (2004) 1|
|Cork stoppers and other cork materials||Resolution ResAP (2004) 2|
|Inks applied to non-food contact surfaces||Resolution ResAP (2005) 2|
|Ion exchange and adsorbent resins||Resolution ResAP (2004) 3|
|Metals and alloys||Resolution CM/ResAP (2013) 9|
|Paper and board|
|Plastic colorants||Resolution AP (89) 1|
|Plastic polymerization aids||Resolution AP (92) 2|
|Rubber||Resolution ResAP (2004) 4|
|Silicones||Resolution ResAP (2004) 5|
Introduction to EU Member State Legislation
At the same time, member states are also free to complement these EU regulations with national legislation, if no EU regulation exists. The reality is that many EU member states have national requirements for one or more of the non-harmonized FCM and/or additional requirements for FCM with harmonized regulations. For example, the EU regulations on ceramics include migration limits for lead and cadmium but, in France these are complemented by legislation administered by the French General Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF), adding migration limits for aluminum, cobalt and arsenic. Unlike general EU requirements, France also demands the composition of metals being used in FCM – e.g. stainless steel must contain at least 13% chromium.
To further complicate matters, the way certain regulations are enforced can be different in each member state. For example, according to Regulation (EC) No 1935/2004, the organoleptic test is a requirement in Article 3. However, in France this test is not performed for all materials or articles, only those that are considered high risk – paper, board, wood, bamboo, varnishes and/or paints. Materials or products that are considered medium risk (plastics, rubber, and silicone rubber) will also undergo the test if the material smells bad. The same sensory test is, however, mandatory in Germany.
EU FCM regulations act as a benchmark for member states but they are not always enough to guarantee compliance in all European countries. Countries outside of the EU may have their own rules, or may have adopted some aspects of EU regulation, such as in Switzerland. At the same time, member states may also add further restrictions or interpret the regulations differently – e.g. Belgium’s Royal Decree on food contact varnishes and coatings has added a stipulation regarding citric acid in the specific migration of varnishes on metal.
Without one single harmonized standard for all European countries, manufacturers must ensure their products are compliant with the target market but, since a product will often be marketed in more than one country, this can be a complex matter.
Beyond the EU
In May 2017, Switzerland’s new rules relating to Food Contact Materials (FCM) started to come into effect, highlighting the complexity of European FCM regulations. Its new ‘Food Law 2017’ adopted provisions from several different European Union (EU) regulations, including ceramic migration limits for lead and cadmium from Directive 84/500/EEC, and for aluminum, barium, cobalt, copper, iron, lithium, manganese and zinc in plastics from Regulation (EU) No 2016/1416. With no harmonized FCM regulation, how do manufacturers and importers make sure they are compliant in Europe?
FCM must not alter the food or bring about any deterioration in its organoleptic characteristics. In simple terms, the FCM that touch food must not change it or endanger human health.
Food Contact Material Testing
SGS has the expertise to help manufacturers and suppliers of FCM achieve compliance with markets around the globe. Our technical experts have extensive experience of testing materials and articles for many markets. We offer the full range of FCM testing, including migration tests, along with expert advice on emerging regulations, compliance issues and documentation review. Our experience can ensure your products meet the appropriate territorial regulations for food contact materials and help pave the way for compliance.