The issue of legislation on food authorisations for silicones is a bit tricky. We explore some concepts of the legislation here.
The European Parliament has adopted Regulation 1935/2004 which regulates materials for direct and indirect food contact. This is a framework and the idea is that a material that comes into contact with food should be secured not to be dangerous for the end user. There are currently (April 2013) a number of finalised regulations, e.g. for plastics, cellulose, ceramics etc. In addition to these materials, Regulation 1935/2004 contains further subheadings, including silicone and glass. These can be seen at the bottom of the overview image (follow the link above).
But - there are no regulations yet finalised under the heading "Silicones". No maximum migration levels, no banned substances, nothing has been developed. Sure, it will come eventually, but nothing is in place yet. The trade association of European silicone companies CES has therefore interpreted this EU legislation as meaning that a silicone material as such cannot be said to be authorised under 1935/2004 - there are no limit values to comply with.
The European Parliament's health body, the EC Health & Consumer Protection Directorate, has published a booklet with questions and answers on food contact materials, where the following can be found:
Question: "5. What is the legal status of the substances not regulated by Community Directives, i.e. additives not included in the Community list, colorants, printing inks, adhesives, aids to polymerisation?"
Answer: "These substances are regulated by national legislation."
Sweden and Denmark currently have no national laws or regulations governing the use of silicones in food applications. This means that each user is left to make their own judgement on whether the materials used are suitable or not.
However, the addition in 1935/2006, Regulation (EC) 2023/2006 on Good Manufacturing Practise (GMP). But the judgement as to whether something is produced according to GMP is, according to the Directive, made by the user: there are no specific guidelines etc. to follow. This is therefore more a question of quality and hygiene and does not govern what a material may contain.
To summarise: Regulation 1935/2006 can be interpreted as meaning that anyone using a silicone in Sweden or Denmark must carry out their own checks to ensure that the silicone is safe for use in food. More detailed directives do not currently exist at EU level.
American FDA (U.S. Food and Drug Administration) unlike the EU, has strict guidelines on the content and authorised migration of silicone. It has become fairly standard in the industry that if a silicone material meets FDA guidelines, it is almost always safe to use in food contact. However, the FDA has different categories of approvals, and it is necessary to check that the intended use falls within the FDA's respective category.
Tribotec has a wide range of silicones with FDA approvals, in bonding, sealing, moulding, defoaming, release agents, oils and emulsions, and more.
Please get in touch if you have any questions about this area!
