Regulatory Compliance Investigation, FCM, FCN Petitioning
Food Contact Materials Compliance according to EU, FDA regulation
Whether you are a user or producer of food contact materials or substances, you want to be sure that you sell products to your customers that are safe for their intended use and are compliant to all relevant legislations. Many of our customers experience an increasing awareness regarding food safety and are faced with an increasing number of questions along the value chain regarding food contact status and particularly NIAS evaluation of their products. The globally scattered legislative landscape regarding food contact materials can be a challenging hurdle to overcome when assessing your products, especially when you are operating internationally.
If you are a manufacturer of food contact substances, you know your product well, but the end uses of your product may be unknown in many cases. If you are a manufacturer of intermediate or finished food contact materials and articles, you perfectly know the intended use of your product, but the exact chemical composition of your product is often unknown. As a trusted third party, we are able to access confidential information to allow dedicated safety and compliance evaluation. Whatever your position is in the value chain, we can get you prepared to give appropriate answers to all customer and authority inquiries regarding the food contact status of your products.
The global legislative landscape for food contact materials is a challenging one.
Major legislative supranational blocks are formed by the EU and FDA. National food contact legislations, such as the Chinese one, are increasingly important as well.
Within the EU, National legislations are still the first point of reference for material types that are not harmonized on the EU level.
This is the case for important material types, such as paper and board, metal, glass, adhesives, coatings, and printing inks.
When there is no National legislation available, risk assessment needs to be done to assess the safety of the product.
Even for plastic materials, for which extensive harmonized EU legislation is in place, reference to National legislations or risk assessment still needs to be made for aids to polymerization, as well as any adhesives, coatings and inks used in the plastic.
Despite the existence of a positive list for substances used in plastics, non-listed substances may conditionally be used as well.
No matter how scattered the field is, what matters to you is whether your product is compliant for its intended use. Based on decades of day-to-day experience in the food contact world, we are your guide in this scattered landscape. Do you need compliance of your product to more than one legislation (e.g. EU and FDA)? Where possible, we will combine tests to save cost and time.
Food contact compliance evaluation is done based on the full chemical composition of the product. If this composition is not known to you, we will contact your supplier(s) to disclose the composition to us confidentially. Theoretical evaluation of the chemical composition of the product usually results in a number of specific migration limits and/or residual contents that need to be verified. For evaluations of non-listed substances our own toxicologists are available. Where possible this will be done by 100% migration calculation or mathematical modelling. The remaining restrictions will be verified by analytical determinations. Once all restrictions are cleared, the analytical report and the food contact compliance statement are issued.
You may only need external support for a part of the full compliance work. For example, you may need only a specific migration test as supporting documentation for your own Declaration of Compliance. We are there to help. Any possible simulant (3% acetic acid, 10%-20%-50%-95% ethanol, iso-octane, olive oil) and test condition (also>100°C) is feasible. A wide range of SML substances is covered by our laboratory, and when no analytical method is available, our analytical experts can develop it. If you are not sure what test conditions have to be chosen, we will advise you on the possibilities.
Non-intentionally added substances (NIAS)
Have you assessed the safety of all NIAS migrating from your products? Can you guarantee that any NIAS present in your product is safe? These questions are increasingly being asked in the food contact materials supply chain. The legal basis is article 19 of (EU) No 10/2011, requiring that non-listed substances, including NIAS, shall be assessed in accordance with internationally recognized principles of risk assessment. What does this mean in practice? What do you actually need to do? A good background reference on NIAS evaluation is a publication of ILSI Europe, although it will not tell you what to do in your situation. When have you done enough? At Triskelion, more than a decade of experience in NIAS evaluation will help you to find the right answers.
Our view is that evaluation of NIAS is not just an analytical screening: a proper risk assessment is based on hazard and exposure. However, we believe that the assessment efforts should be proportionate to the risk, and therefore we promote a pragmatic approach. The chemical composition of the product should be the starting point of the evaluation. Predicted NIAS may be derived from scientific literature. Migration calculation and modelling can be combined with exposure modelling (e.g. FACET) and analytical work to establish the exposure side. Existing restrictions (SML), substance-specific toxicological information, or TTC-approach (Threshold of toxicological concern) will determine the hazard side. There are a lot of choices to make when commissioning a NIAS evaluation. Our analytical experts and toxicologists can advise on best practices. Typically, all our NIAS evaluations are customized to meet your needs. Our aim in such projects is to optimize our efforts to give you the most relevant information on NIAS within the agreed budget. Feel free to contact us to discuss your NIAS concerns.