Food contact materials
By Danielle Cawdron - 23 September 2014
Food contact materials (FCMs) are all materials and articles intended to come into contact with food or drink. These are things that are obvious, like a glass or soft drinks can, and all food and drink packaging materials, but also include machinery in a food factory or a coffee machine, for example. Food contact materials can be constructed from a variety of materials, such as plastics, rubber, paper, coatings etc; in many case a combination is used to construct the final article.
Materials and articles that come into contact with food must fulfil several legislative requirements on physical and chemical safety. European Regulation 1935/2004 lays down the general requirements for all direct and indirect food contact materials as well as active and intelligent packaging ("A&I") materials. It established rules for labelling, certification and record keeping. In addition regulation 1935/2004 established a general safety requirement under Article 3(a) which states:
"Food contact materials must be manufactured in compliance with GMP so that constituents do not transfer into foods in quantities that could endanger human health or bring about an unacceptable change in the composition or organoleptic properties of the food."
Besides these very general rules, some materials are regulated in more detail. Plastics, recycled plastic materials, ceramics, regenerated cellulose films and A&I materials are all controlled by specific legislation. Specific measures have also been adopted for individual substances, such as epoxy derivatives (BADGE, BFDGE, NOGE), N–nitrosamines and N–nitrosatables and bisphenol–A. However, some very common materials such as glass, wood, paper and board have yet to be controlled by specific harmonized European legislation and regulation of these materials only occurs at a national level with requirements often differing between countries.
The legal requirements surrounding the use of plastics as food contact materials are considerable. EU Commission Regulation 10/2011 establishes a positive list of authorised monomers, other starting materials and additives and, for some of them, restrictions on their use. To avoid any contamination of foodstuffs, substances for which no specific migration limit exist, the Regulation set two types of overall migration limits:
Overall Migration Limit – 60mg/kg of food and plastic materials should not transfer their constituents to food simulants in quantities above 10mg/dm2 of food contact surface.
Documentation must be available demonstrating that the limit is being complied with. The intended use of the materials will determine the selection of food simulant along with the test duration and temperature.
Specific Migration Limit – applies to individual authorised substances
If substances with a Specific Migration Limit are used in the manufacture of the material, compliance with the restriction must be demonstrated by means of an analytical test or as a result of a conservative estimation though migration modelling software.
We have UKAS accreditation for overall migration analysis in aqueous and vegetable oil food simulants for plastic articles. In addition we can provide analysis of specific materials, including additives, monomers, photoinitiators and other printing ink components, utilising a wide range of advanced chromatographic and mass spectroscopic techniques.
Migration testing is vital to ensure compliance with the legislation. We can help you ensure that your products comply with applicable regulations. We can also offer advice for gaining compliance for food contact materials outside of Europe, for example against US FDA requirements.