Dr. Joerg Feesche November 2016 How to Determine Safety of a Food Contact Adhesive

Transcription

1 Europespecific content Dr. Joerg Feesche November 2016 How to Determine Safety of a Food Contact Adhesive

2 2/5 How to Determine Safety of a Food Contact Adhesive Analysis of not Listed Substances One important premise of food contact legislation is preventing that food contact materials endanger human health as outlined for example in the European Framework Regulation (EC) No. 1935/2004. It is up to the manufacturer of the food contact material to check whether his material releases certain chemicals and to assess whether or not these constituents are likely to impact human health. However, there is no special regulation explicitly covering food contact adhesives. Some guidance with respect to health risks potentially originating from adhesives can be carried forward e.g. from the Plastics Regulation (Regulation (EC) No 10/2011) or from opinions of the European Food Safety Authority (EFSA) which is the scientific advisory board of the European Commission. In such documents, specific migration limits or threshold levels are published which are usually derived based on comprehensive sets of toxicological data submitted to the authorities. Therefore, if constituents are listed e.g. in the Plastics Regulation or covered by EFSA opinions the concerned adhesive is considered to not pose a risk from a toxicological point of view provided that substances contained in and released by the adhesive do not exceed these respective limits. However, with respect to adhesives there might be certain substances only used in adhesives and therefore not covered by the positive list of the plastic regulation. Also degradation by-products, reaction products or other impurities, the so called Non-Intentionally-Added Substances (NIAS), may be present which are not necessarily covered by the existing regulation or authority opinions. Their presence is for example determined by the Henkel Analytical Center during migration testing of food contact adhesives. For such substances Henkel s Toxicology Group conducts individual risk assessments in order to make sure that consumer health is not affected. Prevention of Health Endangerment Henkel s Risk Assessment Standard advanced e.g. European Framework Regulation Henkel s Toxicology Group For the exposure assessment we closely collaborate with the Henkel Analytical Center. They can contribute very useful information on migration or data obtained by experimentally simulating the fate of a substance during its passage through the human intestinal tract.

3 3/5 How to Determine Safety of a Food Contact Adhesive Risk assessments by Henkel s Toxicology Group A risk assessment is always the combination of the hazard potential and the exposure. Therefore, we first of all need to identify the hazards associated with the particular substance. Often necessary toxicological data are available in our own toxicological archive where we have collected data generated on behalf of Henkel for decades. Furthermore, we have access to all relevant external toxicological databases. Such existing data often allows to evaluate whether or not a certain substance could endanger human health. In cases where no sufficient data exists, we can start the assessment focusing on the concerned chemical structures. At the very beginning of such an assessment we often conduct computer based modeling (QSAR) in order to identify potentially critical structural elements. The next step is the identification of structurally similar chemicals for which test data exist followed by an extrapolation of this data to the chemical in question (read-across approach). If necessary we can of course also generate necessary data by initiating safety testing at external collaboration partners, e.g. Contract Research Organizations. Many of those are part of our scientific network. For the exposure assessment we closely collaborate with the Henkel Analytical Center. They can contribute very useful information on migration or data obtained by experimentally simulating the fate of a substance during its passage through the human intestinal tract. Based on such information the potential consumer exposure can be estimated. Comparing this exposure with the identified toxicological profile enables us to establish a so called Margin of Safety which is considered a safety indicator, e.g. there is no health risk expected if this margin is high enough. Finally, application of the Threshold of Toxicological Concern (TTC) concept turned out to be a valuable approach for chemicals with an unknown hazard profile. In line with EFSA guidelines, this concept allows to determine human exposure levels which will pose only a negligible risk.

4 4/5 How to Determine Safety of a Food Contact Adhesive Key Take Aways For non-approved substances, degradation by-products, Reaction products and impurities, Henkel s toxicology group conducts individual risk assessments. There is a close cooperation of Henkel s toxicological and analytical department on exposure assessment and an exchange of information about migration. The key objective is to prevent that food contact materials endanger human health. On behalf of Henkel, the toxicology group has collected vast toxicological data for years. If no data is available, a hazard assessment may include computer based modeling (QSAR) in order to identify critical structural elements followed by read-across or the application of the TTC-Concept. Missing data can also be generated by initiating safety testing at external collaboration partners. Literature and Useful Links EFSA Scientific Publications Threshold of Toxicological Concern (TTC) Concept Kroes, R., Renwick, A.G., Cheesman, M., Kleiner, J., Mangelsdorf, I., Piersma, A., Schilter, B., Schlatter, J., van Schothorst, F., Vos, J.G., Würtzen, G., Structure-based thresholds of toxicological concern (TTC): guidance for application to substances present at low levels in the diet. Food and Chemical Toxicology 42, EFSA Opinion on TTC Concept EFSA, Supporting publication 2016:EN-1006, Review of the Threshold of Toxicological Concern (TTC) approach and development of new TTC decision tree, 2016 Computer based modeling OECD Toolbox

5 5/5 How to Determine Safety of a Food Contact Adhesive Meet Your Experts Dr. Joerg Feesche is a certified toxicologist in Henkel s Corporate Product Safety Department. With a focus on end-consumer safety, he is involved in toxicological evaluations related to Henkel s industrial adhesives and their raw materials. In this function, he particularly cares for adhesives intended to be applied in sensitive sectors like medical devices, hygiene or food contact. Further Information Visit the Food Safe Packaging Premium Area offering webinars, white papers, FAQs, videos and more: Contact us! Many options available. Webinars Our webinars allow you to directly communicate with our Henkel food safety experts. Check our website for the dates of upcoming webinars. Henkel AG & Co. KGaA Düsseldorf, Germany The information provided herein, especially recommendations for the usage and the application of our products, is based upon our knowledge and experience. Due to different materials used as well as to varying working conditions beyond our control we strictly recommend to carry out intensive trials to test the suitability of our products with regard to the required processes and applications. We do not accept any liability with regard to the above information or with regard to any verbal recommendation, except for cases where we are liable of gross negligence or false intention. The information is protected by copyright. In particular, any reproductions, adaptations, translations, storage and processing in other media, including storage or processing by electronic means, enjoy copyright protection. Any exploitation in whole or in part thereof shall require the prior written consent of Henkel AG & Co. KGaA. Except as otherwise noted, all marks used in this document are trademarks and/or registered trademarks of Henkel and/or its affiliates in the US, Germany, and elsewhere. Henkel AG & Co. KGaA, 11/2016