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 be safe for the consumer. In addition, these Food Contact Materials (FCM) must not alter the food or bring about any deterioration in its organoleptic characteristics. In simple terms, the FCM that touch our foods must not change our food or endanger human health.
Many countries have FCM regulations to help make sure food is not tainted before it reaches the consumer but without a single FCM regulation covering all of Europe, companies need to be sure they understand the regulations that apply to their market. They must also stay alert, 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 is complicated. FCM are assessed via three broad criteria. Firstly, there is the composition of the material or article. FCM must be made from substances which will not harm the consumer. There are some proscribed substances, for example bisphenol A (BPA), which manufacturers must avoid in some European countries. Regulation (EU) No 10/2011 lists around 1,000 chemical substances that can be used as monomers or additives in plastic composition.
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 and fat 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. As with the organoleptic tests, to give an accurate idea of the levels of migration the tests must consider different temperatures and contact times, determined according the real use of the article.
Within the EU, FCM are assessed by the European Food Safety Authority (EFSA) but there is no single regulation covering all FCM. The EU’s harmonized legal framework, Regulation (EC) No 1935/2004, sets out the general principles of safety and inertness for FCM, but it is not the whole story. FCM are also covered by regulations dependent upon the material involved, 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
EU Member States are also able to add national regulations to these EU regulations, if no EU regulations exist. For example, EU regulations on ceramics include migration limits for lead and cadmium, France has then added migration limits for aluminum, cobalt and arsenic, administered by the French General Directorate for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF). France also demands analysis of the metals being used in FCM – e.g. stainless steel must contain at least 13% chromium - unlike general EU requirements.
To further complicate matters, regulations can also be enforced in different ways 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. A good example of this is Switzerland, which adopted provisions from several EU regulations for its new ‘Food Law 2017’. These included ceramic migrations 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.
SGS’s technical experts have extensive experience of testing materials and articles in contact with food. They 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 regulations for food contact materials and pave the way for compliance in markets around the world. To learn more about SGS’s Food Contact Testing Services.
For further information contact:
Global Expert, Food Contact Materials and Chemical E&E
SGS CTS (France)
Tel: (+33) 2 35 07 92 66
Hing Wo Tsang, Ph.D.
Global Information and Innovation Manager
SGS Hong Kong Limited
Tel: (+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.