Silicone and Food Safety

September is National Food Safety Education Month; its purpose is to raise awareness of safe food preparation and cooking practices, to prevent cross contamination and food poisoning. Consider how many materials your food comes into contact with before it reaches your mouth. Reducing the risk of contamination is critical, and there is legislation that must be complied with for products to be deemed safe to use with food.

EC 1935/2004 is a Food contact Materials Regulation instated in October 2004 by the European Parliament and the Council of the European Union. Their aim was to standardise the requirements for food contact materials across the EU. However, the legislation does not currently hold testing standards for silicones, so in the absence of specific regulation for the industry, it is implied that FDA grade materials, and materials compliant to German BFR Recommendation XV – as well as the French Arrêté of 25 Novembre 1992 – are therefore fully compliant with the EU1935/2004 legislation.

So, what is FDA?

FDA stands for the Food and Drug Administration, which is the Federal Agency of the Department of Health and Human Services in the USA. The FDA’s responsibility is to protect public health by ensuring that the manufacture and use of drugs, biological products, food and medical devices are safe for human use and consumption. They assure that manufacturers follow safety laws, so that products are produced without harmful contaminants and are clearly labelled for consumers.

The specific regulation we are speaking of is ‘FDA 21 CFR 177.2600 – rubber articles intended for repeated use.’ This sets out the chemicals that are allowed to be used in FDA classified rubbers, and how they should be processed.

When a material is in contact with food, particles may transfer from the material to the foodstuff – known as migration. Migration tests are performed on materials to assess their safe use with food; the migration of the chemicals must fall within certain tolerances, or limits, to allow the material to be classified as food safe.

Good manufacturing practise or ‘GMP’ that ensures full traceability of items is key in ensuring products comply to these standards. GMP is also set out in EU regulation 2023/2006 which Silex clearly exceeds. Using the wrong materials or using untrustworthy suppliers could cost your company dearly.

Here at Silex, we have a wide range of FDA products to suit your needs. As an ISO 9001 accredited company, we are happy to provide full traceability to demonstrate all items are processed and post-cured in accordance with the standards required to meet FDA status. As well as confirming our products follow manufacturing standards EU regulation 2023/2006 we also provide this data on our website for you in the form of migration test data.

As well as FDA compliancy, we manufacture products that are BfR accredited. BfR is the German Federal Institute for Risk Assessment, and they ensure that materials do not release substances into food that could cause health risks to consumers. Where FDA regulations are applicable, BfR is typically recognised as well. BfR imposes the limit of <0.5% of volatiles for a product to be deemed food safe. It is important to know and understand the test data when purchasing items that you believe to be BfR or FDA compliant. Signs that a product may not be post-cured correctly can include a strong smell and tackiness. If you are unsure if your current supplier is providing you with FDA grade materials, ask them for test data. Alternatively, contact our team to see if we can assist.

In summary, products that are labelled as FDA and/or BfR compliant are safe to use in contact with food and beverages which will be supplied for human consumption. It means that the products don’t contain harmful chemicals and won’t leach bi-products which could pose a risk to someone’s health. As suppliers to a huge range of multinationals in the Food and Beverage Industry we keep stock of a large range of approved materials that are readily available on our online shop. Furthermore, If you have any questions or concerns regarding a project the team at Silex have a wealth of experience and expertise to advise you on your best options – not only for your FDA requirements, but other important criteria such as WRAS approval or USP Class VI compliance as well.