Complexity in Food Contact Material Regulations: A European Perspective
The EU does have a harmonized legal EU framework, Regulation (EC) No 1935/2004, which sets out the general principles of safety and inertness for FCM, but it is not the whole story.
In May 2017, Switzerland’s new rules relating to Food Contact Materials (FCM) started to come into effect, highlighting the complexity of European FCM regulations1. 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) 2016/1416. With no harmonized FCM regulation, how do manufacturers and importers make sure they are compliant in Europe?
The food you eat will touch many materials and articles during its production, processing, storage, preparation and serving, all before it is eventually consumed. The substances we use to build processing machinery, manufacture packaging, and even the equipment we use to store, cook and eat the food in our own homes, must present no danger to the consumer. In addition, FCM must not alter the food or bring about any deterioration in its organoleptic characteristics. In simple terms, the FCM that touch our food must not change our food or endanger human health.
To make sure food is not tainted before it reaches the end consumer, many countries have regulations regarding FCM but manufacturers need to be sure they are complying with the right standards for their target market. Stakeholders must stay up-to-date, as these regulations are regularly updated both nationally and internationally.
What are FCM?
FCM and articles are defined as materials and products that:
- Are intended to be brought into contact with food
- Are already in contact with food and were intended for that purpose
- Can reasonably be expected to be brought into contact with food or to transfer their constituents to food under normal or foreseeable conditions of use
FCM regulations are complex because the objective of the legislation is complicated. FCM are assessed via three broad criteria. Firstly, there is the composition of the material or article. There are some proscribed substances, for example bisphenol A (BPA), which manufacturers must avoid. Regulation (EU) No 10/2011 lists around 1,000 chemical substances that can be used as monomers or additives in plastic composition. FCM must be made from substances which will not harm the consumer.
Secondly, there is the organoleptic test, using standard EN 1230-1 and -2 or DIN 10955. This is complex because not all foods are the same, materials act differently at different temperatures and the senses of consumers are not standardized. When simulated foods are used during testing, dry foods and wet foods will react differently and the results from ‘smelling’ (orthonasal olfaction) and ‘tasting’ (retronasal olfaction) will be different. In general, dry goods will show the despoiling better in ‘smelling’ tests and wet goods in ‘tasting’ tests.
Finally, there are the tests for migration – the transfer of constituent parts of the FCM, or the whole, onto the foodstuff. Again, as with the organoleptic tests, the tests for migration must consider different temperatures and contact times, to give an accurate idea of the levels of migration.
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 safety and inertness for FCM, but it is not the whole story. Different forms of FCM are also covered by their own regulations, for example:
- Ceramics: Directive 84/500/EEC, amended by Directive 2005/31/EC
- Regenerated cellulose film: Directive 2007/42/EC
- Plastics: Regulations (EU) 10/2011 with seven amendments
- N-Nitrosamines and N-nitrosatable substances from elastomer or rubber teats and soothers: Directive 93/11/EEC
- 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 (plastics): Regulation (EC) No 1895/2005
At the same time, Member States are also free to complement these EU regulations with national legislation, if no EU regulations exist. For example, 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 arsenic2. Unlike general EU requirements, France also demands analysis of the 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) No1935/2004, 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, bamboos, varnishes and/or paints. Materials or products that are considered medium risk (plastics, rubber, 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 metal3.
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.
SGS Solutions: Food Contact Testing
SGS has the expertize 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 the Brazilian, North American, Chinese and European markets, in addition to several other territories. We offer the full range of FCM testing, including migration tests, along with expert advice on emerging regulations, compliance issues and documentation review. SGS’s experience can ensure your products meet the appropriate territorial regulations for food contact materials and help pave the way for compliance.
To learn more about SGS’s Food Contact Testing Services.
Global Expert, Food Contact Materials and Chemical E&E
SGS CTS (France)
t: +33 2 35 07 92 66
HingWo Tsang, Ph.D.
Global Information and Innovation Manager
SGS Hong Kong Limited
t: +852 2774 7420
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 90,000 employees, SGS operates a network of over 2,000 offices and laboratories around the world.