26 April 2013

Silicones for food - EU Regulation 1935/2004 and 2023/2006

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The question of the legislation surrounding food approvals for silicones is a bit tricky. We investigate some concepts within the legislation here.

The EU Parliament has adopted regulation 1935/2004 which regulates materials for direct and indirect food contact. This is a framework and the idea behind it is that a material that comes into contact with food should be secured so as not to be dangerous to the end user. There are today (April 2013) a number of completed regulations, e.g. for plastics, cellulose, ceramics, etc. In addition to these materials, Regulation 1935/2004 contains additional subheadings, including silicone and glass. These can be seen at the bottom of the overview image (follow the link above).

But - there are still no regulations at all ready under the heading "Silicones". No maximum migration levels, no banned substances, nothing is produced. It will surely come eventually, but nothing is in place yet. The trade association of the European silicone companies CES have thus interpreted this EU legislation as meaning that you cannot say that a silicone material as such is approved according to 1935/2004 - there are no limit values to adapt to.

The European Parliament's body for health, the EC Health & Consumer Protection Directorate, has issued a booklet with questions and answers around food contact material, and there the following can be found:

Question: “5. What is the legal status of the substances not regulated by Community Directives, ie 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 how silicones may be used in food contexts. This means that each user is directed to make their own assessment of whether the materials used are suitable or not.

However, the amendment in 1935/2006, regulation applies (EC) 2023/2006 on good manufacturing practice (GMP, Good Manufacturing Practice). But the assessment if something is produced according to GMP is made according to the directive by the user: there are no specific target values etc. to follow. This is therefore more a matter of quality and hygiene and not governing what a material may contain.

In summary: regulation 1935/2006 can be interpreted as meaning that whoever uses a silicone in Sweden or Denmark must carry out their own check that the silicone is okay to use in a food context. More detailed directives do not currently exist at EU level.

American FDA (US Food and Drug Administration) unlike the EU, has strict guidelines for content and permitted migration in silicone. It has become relatively 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 several categories of approvals, and one must agree that the intended area of use is covered by the FDA's respective category.

Tribotec has a large number of silicones FDA approvals, in gluing, sealing, embedding, foam suppression, release agents, oils and emulsions, and more.

Feel free to get in touch if you have any questions about this area!