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Assessment of the risk of consumers exposure to the substances migrating from food contact materials and articles Cologne 17th October 2011 P.K.T. Oldring Valspar Corporation 1 The Problem / Issue - 1 Article 3 of the Framework Regulation (EC) No. 1935/2004 effectively states that substances from FCMs must not migrate in quantities which could endanger human health. It does not tell you how to ensure that human health is not endangered. For plastics there is a Regulation (PIM 10/2011) which if followed can be used to demonstrate compliance for plastics with 1935/2004. For non-plastics, the restrictions for plastics are frequently used to demonstrate compliance with 1935/2004. 2 The Problem / Issue - 2 Even plastics have issues as they are not fully legislated, other than by 1935/2004, e.g PPAs. For non-harmonised FCMs (i.e. non-plastics) national legislation, where it exists applies, and can be used. But national legislation can vary from country to country. For non-plastics without harmonised EU legislation there can be real issues. Without harmonised EU legislation or guidance on how to assess risks from migrants from FCMs, different authorities can interpret the same results differently 3 The Problem / Issue - 3 4 NIAS (non-intentionally added substances) and how to assess any associated risk is becoming more prominent. A new way of realistically assessing risk is required and this has to be accepted by ALL – industry and regulators / enforcement authorities. Traditionally risk in EU is driven by hazard rather than a realistic estimate of exposure. Exposure is assessed by assuming that a consumer weighs 60 kg and eats 1 kg food / day packaged in the same FCM and that the substance migrates at its maximum permissible level (SML). The Problem / Issue - 4 Not all substances in FCMs have been fully assessed by SCF / EFSA. This is particularly true for non-plastics. Indeed there are more non-plastic FCM substances than plastic ones. NIAS, PPAs etc have definitely not been assessed. EFSA, Member States and DGSanco recognise these issues. EFSA cannot fully evaluate all substance used in FCMs in a reasonable time frame. 5 Latest Developments The following are the latest developments 1. EFSA/ESCO non-plastic FCM report issued. 2. ILSI TTC paper published 3. EFSA TTC Consultation document published 4. EFSA evaluation of the Cramer Classification applied to FCS (for which actual tox data exist) - in press 5. FDA paper on oligomers All refer to the use of exposure to assess risk! 6 Exposure - 1 Even the most toxic substances cannot endanger human health if there is no exposure to them. Paracelsus – the dose makes the poison. Hence having ascertained the hazard it is necessary to determine the exposure to the hazard. The use of TTC concepts and Cramer Classes require an estimate of exposure Exposure can be estimated either deterministically or probabilistically. Need to ensure high consumers are protected hence per-capita approach per-se is not acceptable 7 Exposure - 2 A high consumer cannot be a high consumer of each and every foodstuff. Deterministic approaches use conservative estimates of both amount of foodstuff consumed and concentration of migrant(s) in those foodstuffs. More recently there have been a number of probabilistic approaches to estimate exposure – e.g. UCD, CSL – and more recently the FACET project. 8 What is FACET? - 1 FACET = Flavourings, Additives (food), Contact materials, Exposure Task Risk Assessment and hence Risk Management Tool. EU Commission funded project ~ €5.9 Mio. + some Member State funding (~€1 Mio) + some industry funding (~ €400k) - each association has agreed to contribute €10,000 per year for 4 years commencing 2008. + industry in kind (~ / >(?) €2 Mio) Total value of project > €8 Mio. Packaging accounts for ~50% of project 9 What is FACET? - 2 There are 20 partners of which FIG (FACET Industry Group) is one. There are 10 work packages and the national food consumption data from 8 EU countries are used. Modelling to interpolate food consumption from 8 representative EU countries to ALL EU Member States is the subject of one work package. 10 What is FACET? - 3 FIG (FACET Industry Group) consists of 12 trade associations covering metal, plastics, paper and board, adhesives, inks, waxes, European food industry. Glass industry decided not to participate! FIG is mainly concerned with the packaging part of FACET, but there have been, and are ongoing, interactions with other partners. Migration modelling Food coding Food consumption Regional modelling of exposure 11 Schematics of how FACET model will work particularly for packaging 12 HOW MODEL IS RUN Substance of interest How much of each food is eaten? Exposure = concentration x weight of food 13 Where is substance used? In what FCMs. How much can migrate? Repeat for all consumers How much is in FCM? What foods are packed in these FCMs HOW MODEL IS RUN – INPUTS FROM INDUSTRY AND OTHERS Substance from list Where is substance used? How much is in FCM? How much of this food is eaten? What foods eaten contain substance? How much can migrate? Exposure = concentration x weight of food 14 Repeat for all consumers industry others WP4. Food Packaging - 1 Objectives of WP 4 To obtain information on the chemical composition of food packaging materials To link foods consumed with concentration of migrants from its packaging To establish a migration modelling framework to deliver realistic estimates of exposure for subsequent use in risk assessment. 15 WP4. Food Packaging - 2 Packaging is WP4 which is split into 3 subsections WP 4.1 Packaging usage and substance occurrence data WP 4.2 Modelling migration of substances from FCMs. WP 4.3 Use of QSAR for assessing toxicology of migrants Packaging industry consortium involved as a partner in WP4 as the FIG (FACET Industry Group) 16 WP 4.1 Packaging usage and substance occurrence data 17 Summary of progress made - 1 6475 substances in FCM (direct or indirect) compiled – some may not be used Many substances are used by two or more packaging sectors. Some substances are also either direct food Additives or Flavour substances. FACET database indirectly links with the new DG-SANCO database covering EU-regulated FC-substances 18 Summary of progress made - 2 252 material codes plus 179 which are ink related (i.e. different inks, ink for different substrates and ways of printing substrate e.g. reverse or surface) Most sectors will use migration modelling, hence concentration range in material needed. Others will use analytical data FIG (FACET Industry Group) purchased additional EuroMonitor (EM) data to cover 20 Member States Linked with food item descriptions - 18 food packaging categories with common tier 0 and lower tiers of 56 and 172 categories 19 Supporting migration modelling FIG clustered 431 material codes to 26 representative materials for which modelling parameters exist or will be obtained to for diffusion and partition coefficients. FIG (including FDE (ex CIAA) clustered 172 packaging food groups to 31 representative foods where parameters exist. Ready Meals most challenging and solutions proposed. 20 WP 4.2 Migration Modelling of substances from FCMs. 21 Migration Modelling 22 Test materials for migration studies were selected to ensure all packaging sectors to be modelled are covered Experimental studies to derive missing data for representatives material nearly complete. Data collated for: 31 representative foods 3 temperatures 20 model substances (migrants) Representative material groups Non polar e.g. Polyolefin Medium polar e.g PET Polar e.g. polyamide WP 4.3 Use of QSAR for assessing toxicology of migrants 23 (Q)SAR modelling of Hazard Manual link to OECD Toolbox Need SMILES structure for substance Existing published tox data retrieved Possible for Cramer Class evaluations About 150 substances of differing complexity have been run with various degrees of success by Fera Staff. For some substances Cramer Class approach is not suitable More sophisticated modules also incorporated – but need tox knowledge for interpreting Oligomers present an issue – see later - FDA paper 24 Latest developments from EFSA, EFSA/ESCO, ILSI and FDA 25 Latest Developments - 1 EFSA/ESCO report endorses the use of thresholds of toxicological concern (TTC) to set levels of tolerable exposure for different chemical classes. ILSI proposed a step-wise approach By following this step-wise approach, it may be possible to apply a TTC threshold of 90 µg/person/day for an unknown substance The EFSA TTC approach propose that the following human exposure threshold values are sufficiently robust and conservative to be used in EFSA’s work; 26 Latest Developments - 2 0.15 µg/person per day for substances with a structural alert for genotoxicity This TTC also applies to substances for which the structure is totally unknown. 18 µg/person per day for organophosphate and carbamate substances with anticholinesterase activity 90 µg/person per day for Cramer Class II & III substances 1800 µg/person per day for Cramer Class I substances, 27 Latest Developments - 3 BUT for application to ALL groups in the population, these values should be expressed in terms of body weight, i.e. 0.0025, 0.3, 1.5 and 30 µg/kg body weight per day, respectively. Use of the TTC approach for infants under the age of 6 months, with immature metabolic and excretory systems, should be considered on a case-by-case basis. 28 Latest Developments - 4 EFSA Evaluation of Cramer Classes concluded that: The TTC approach, as proposed by Munro et al. in 1996, appears to be more conservative (more protective for consumers) than the complete individual risk assessment for 95.9 % of the 845 compounds included in the extended (Munro and FCM for which EFSA had full tox dossiers) substances dataset. These figures suggest that the TTC approach can be a useful tool for prioritisation of evaluations of lists of substances for which no toxicity data are available. 29 FDA paper on Oligomers - 1 “Based on an analysis of the available data, accepting toxicity data of monomers as a component of a weight-of-evidence safety decision on polymeric foodcontact materials, in general, does appear to be a conservative approach for assessing genetic toxicity and potential carcinogenicity for dietary exposures ≤150 µg/person/day. Such an analysis is assisted by also including a discussion of where the reactive groups on genotoxic or carcinogenic monomeric components may have been altered or eliminated in the polymeric material and SAR analysis of representative structures of the oligomers.” 30 FDA paper on Oligomers - 2 “Clearly, consideration of the LMWOs is an important component of evaluating the safety of polymers used in food contact materials. When concerns exist regarding reactivity or SAR, further testing may be required; however, the use of the approaches described herein can, in general, be used to make a safety determination.” 31 References 1. EFSA/ESCO - 2011:EN-139. Report of ESCO WG on non-plastic Food Contact Materials. European Food Safety Authority, Parma, Italy. 25 July 2011. 2. ILSI TTC - Application of the TTC concept to unknown substances found in analysis of foods. S. Koster, A. R. Boobis, R. Cubberley, H. M. Hollnagel, E. Richling, T. Wildemann, G. Würtzen and C. L. Gall. Food and Chemical Toxicology 2011, 49, 1643–1660. 3. EFSA TTC - Draft Scientific Opinion on Exploring options for providing preliminary advice about possible human health risks based on the concept of Threshold of Toxicological Concern (TTC). Public consultation, July 2011. 4. EFSA Cramer Class - Threshold of Toxicological Concern approach for the risk assessment of substances used for the manufacture of plastic Food Contact Materials. R. Pinalli, C. Croera, A. Theobald and A. Feigenbaum. Trends in Food Science and Technology, 2011, in press. 5. FDA - Assessing the toxicity of polymeric food contact substances. Chad P. Nelson, Geoffrey W. Patton, Kirk Arvidson, Helen Lee, Michelle L. Twaroski. Food & Chemical Toxicology 49 (2011) 1877 – 1897 32 Summary These TTC concepts coupled with the advances in estimating migration and exposure that FACET will bring, will be significant developments in our capabilities to make better scientifically-based risk assessment of migration from FCMs. For an overview of the FACET project consult the September (2011) publication: A. Hearty et al: Food Science & Technology (2011), Vol, 25 (2), 26-29. 33 THANK YOU FOR YOUR ATTENTION FACET WEB SITE www.ucd.ie/facet 34