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Regulatory Compliance Investigation, FCM, FCN Petitioning
Food Contact Materials Compliance according to EU, FDA regulation

FCM Compliance

サンプルイメージ Food safety a concern? We can help! Are you involved with food contact materials? Whether you make or use them, ensuring safety and legal compliance is crucial. Customers are asking more about food safety, especially regarding a FCM status and its compliance with regulations. Navigating global food contact regulations can be tough, particularly for international businesses. We understand your challenges. As a manufacturer, you might know your product well, but not its final use. Conversely, you might know the intended use of a finished product, but not its exact chemical makeup. That's where we come in. We're a trusted partner with access to confidential information. We can help you evaluate your product's safety and compliance, regardless of your position in the supply chain. With our help, you'll be prepared to answer any questions from customers or authorities about your food contact materials.



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>100C) 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.

Recycling of plastic materials and articles intended to come into contact with foods
Recycled plastic with the intended use as food-contact material (FCM) needs to be recycled at a high safety level. EFSA defined different requirements for recycling processes depending on whether they are based on a Suitable technology or developed as a Novel technology [1].
For FDA, a uniform approach is recommended to show that the recycled material is safe for use in contact with food [2].
Both organizations consider a challenge test an important element of the safety evaluation.

[1] Commission Regulation (EU) 2022/1616 of 15 September 2022 on recycled plastic materials and articles intended to come into contact with foods, and repealing Regulation (EC) No 282/2008
[2] Center for Food Safety and Applied Nutrition, Office of Food Additive Safety: Guidance for Industry: Use of Recycled Plastics in Food Packaging (Chemistry Considerations), July 2021.
[3] EFSA Panel on food contact materials, enzymes, flavourings and processing aids (CEF); Scientific Opinion on the criteria to be used for safety evaluation of a mechanical recycling process to produce recycled PET intended to be used for manufacture of materials and articles in contact with food. EFSA Journal 2011;9(7):2184.

News Apr-2024; Short notice on the 18th amendment to Plastic regulation EU 10/2011

In March 2024 the EC published its draft 18th amendment to the plastic regulation EU No 10/2011 on plastic materials and articles intended to come into contact with food and amending Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food. It concerns recycled plastic and other matters related to quality control and manufacturing of plastic materials and articles intended to come into contact with food.

It involves among others
1. new labeling requirements (the maximum lifespan for repeated use articles),
2. adjusting requirements for migration testing (use the actual surface to volume ratio for small articles less than 500 mL, specific performance criteria for analytical methods used during compliance testing),
3. new requirements concerning the “high degree of purity” for the substances that are used for the manufacturing of plastic material and articles and,
4. adjusting the rules for re-processed plastics.
One concern is adjustments that involve the high degree of purity requirements that will be added to new article 3a and to article 8 related to starting substances and intermediates and includes substances of natural origin or from waste material.

High degree of purity: A substance used in the manufacture of plastic materials and articles shall be considered as having a high degree of purity where all of its constituents form part of its identity, and it otherwise contains only a minor amount of contaminants and non-intentionally added substances that fulfil one of the following conditions;

1. comply with the relevant regulations,
2. considered compliant after risk assessment,
3. genotoxicity is ruled out after individual tox assessment and present at residual levels below 0.05 mg/kg food or
4. if genotoxicity cannot be ruled out based on ii) or iii) and assuming their full migration from the final article into food is below 0.00015 mg/kg food.
These adjustments on the regulation will have a significant impact on the whole supply chain, and this was underlined by that no less than 124 parties have submitted their comments and concerns on this draft version.

Our experts can be of assistance with implementing this new amendment for your products once into force. Triskelion dedicated services includes the investigation for the high degree purity of your substance or intermediate. This includes chemical analysis of your substance for impurity profiling via screening techniques using sophisticated equipment and the corresponding risk assessment, all performed by our highly skilled professionals.

News Feb-2024; Food safety - Restrictions on bisphenol A (BPA) and other bisphenols in food contact materials:

The EU is preparing to tighten its rules on the use of bisphenol A (BPA) and related chemicals in food contact materials. This initiative will impose a ban on the use of BPA in food contact materials (FCMs), including plastic and coated packaging. This is due to health concerns about the presence of BPA in food. The proposed changes will include a ban on the use of BPA in the manufacture of plastic food contact materials and other materials, including varnishes and coatings, printing inks, and adhesives. There are also proposed restrictions or specific requirements on the use of disodium salt of BPA and other bisphenols. A limited exception is proposed for the use of bisphenol-A diglycidyl ether (BADGE). Recognising that a ban would have a major impact on manufacturers of food contact materials, transition periods are being discussed to avoid disrupting the food supply. Suppliers of packaged fruit, vegetables, and fishery products are likely to face particular challenges.
Link to EU Food safety- Restrictions on bisphenol A (BPA) and other bisphenols in food contact materials: