Recent Progress in the Risk Assessment of FCMs. Laurence Castle

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1 Recent Progress in the Risk Assessment of FCMs Laurence Castle

2 Recent Progress in the Risk Assessment of FCMs TOPICS: 2016 EFSA opinion on FCM 2016 EFSA-WHO Review of the TTC Considerations of Nano Considerations of Gentox New (2016) EFSA WG on Mixtures

3 EFSA CEF Panel opinion on Recent development in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in FCM January 2016 Intended to update science underlying the existing GUIDANCE DOC

4 Scope Although only for substances:- (i) used in plastics, and ii) subject to EU authorisation the opinion indicates EFSA thinking about the science underpinning the safety assessment of any substance that migrates from any FCM i.e. IAS, NIAS, non-harmonised (not plastic) materials, etc...

5 Background Wanted to:- Cover better the exposure of infants & toddlers Update toxicological data requirements and methods Strengthen the RA of NIAS including oligomers Continues with a Tiered approach The higher the exposure, the greater the amount of toxicological data is required.

6 Suggested new exposure scenarios Based on the intended use(s) of the FCM containing the substance under evaluation: 4 scenarios Cat. No Food categories for which the FCMs containing the substances under evaluation are intended to be used Population driving the highest consumption Food Consumption* to be considered for the estimation of the exposure 1 Water and baby bottles contents such as reconstituted milk formula 2 Beverages such as nonalcoholic drinks, milk, other liquid milk based products 3 Solid foods specifically intended for infants and toddlers 4 Foodstuffs not covered by Categories 1-3 Infants 150 g/kg bw/day Toddlers 80 g/kg bw/day Toddlers 50 g/kg bw/day Toddlers 20 g/kg bw/day *Food consumption (from the EFSA Comprehensive Food Consumption Database) corresponding to the intended use.

7 Tiered approach to tox data requirements Based on highest calculated exposure (µg/kg bw/day) EXP < 1.5 Or if substance is Cramer class I EXP < 30 EXP is >1.5 or >30 But 80 EXP> 80-2 genotoxicity tests in vitro - available information including a literature search More data if (1) if existing data indicate potential to affect endocrine or neural systems; (2) for substances with a high potential to accumulate in humans; (3) for nano As above, PLUS: - extended 90-day oral toxicity study in rodents (* with, if there are existing data indicating endocrine activity suggesting potential effect from prenatal exposure, a prenatal treatment period or an extended one generation reproduction study - an ADME for substances for which a potential for accumulation in man could be anticipated As above, PLUS: - study on ADME - studies on reproduction & developmental toxicity - studies on long-term toxicity (*)/carcinogenicity

8 Change in Tiers for tox data requirements Proposed tiers are similar to those currently:- Current mg/kg food Current * µg/kg bw/d New ** µg/kg bw/d < 0.05 < 0.83 < > 5 > 83 > 80 * Exposure = migration /60; from 1 kg food pp/p and 60 kg bw ** 1.5 corresponds to Cramer class III (1.5 x 60 = 90 µg) 30 corresponds to Cramer class I (30 x 60 = 1800 µg)

9 Consideration on NIAS, inc. oligomers Tiered approach applies to all migrating substances For NIAS which migrate into foods, further considerations on genotoxicity testing e.g. Oligomers: read-across from monomers, considerations of hydrolysis, metabolism,.. NIAS other than oligomers: computational methods (SAR, QSAR), TTC

10 Next Steps EFSA CEF Panel opinion on Recent development in the risk assessment of chemicals in food and their potential impact on the safety assessment of substances used in FCM January 2016 Stepwise approach agreed with EC Next step is for EC to set level of protection for consumers Then, EFSA will prepare a new Guidance Document for applicants / dossiers Hopefully, the new Guidelines (and even the 2016 Opinion as an interim) will be widely adopted/followed by others doing their own RA.

11 Recent Progress in the Risk Assessment of FCMs TOPICS: 2016 EFSA opinion on FCM 2016 EFSA-WHO Review of the TTC Considerations of Nano Considerations of Gentox New (2016) EFSA WG on Mixtures

12 2016 EFSA-WHO Review of the TTC The TTC approach is a tool for the safety assessment of chemicals when hazard data are incomplete and human exposure can be estimated. Reaffirmed: The Cramer Classes are OK and no recalibration is needed (yet). The TTC for genotoxic compounds is sufficiently protective Review of the Threshold of Toxicological Concern (TTC) approach and development of new TTC decision tree. EFSA and WHO, March 2016.

13 Cramer values of 90, 540 and 1800 µg pppd Review of the TTC approach and development of new TTC decision tree. EFSA and WHO, March 2016

14 2016 EFSA-WHO Review of the TTC Cramer Classes are OK and no recalibration is needed (yet) 145 chemicals found in personal and household products (Blackburn et al., 2005) 91 reproductive and developmental oral toxicity data (Bernauer et al., 2008) 100 active pesticides and 15 pesticide metabolites (Brown et al., 2009) 232 FCM substances (Pinalli et al., 2011) 521 chemicals in the RepDose database (Tluczkiewicz et al., 2011) 813 different chemicals from subacute and subchronic studies (Kalkhof et al., 2012) 283 chemicals with reproductive and developmental toxicity data (Laufersweiler, 2012) 328 pesticides (Feigenbaum et al., 2015) Original Cramer values crosschecked using several other data sources

15 Review of the TTC approach and development of new TTC decision tree. EFSA and WHO, March 2016

16 TTC - Exclusion of chemical categories The application of the TTC approach is not recommended for the following categories of chemicals: High potency carcinogens (i.e. aflatoxin-like, azoxy- or N- nitroso-compounds, benzidines), compounds not adequately covered in the database, inorganic chemicals, metals and organometallics, proteins, steroids, nanomaterials, radioactive substances and organosilicon compounds or chemicals that are known or predicted to bioaccumulate. TTC is not applicable when compound-specific assessment and toxicity data are available or are required under existing regulations. So, IAS but NIAS

17 Recent Progress in the Risk Assessment of FCMs TOPICS: 2016 EFSA opinion on FCM 2016 EFSA-WHO Review of the TTC Considerations of Nano Considerations of Gentox New (2016) EFSA WG on Mixtures

18 Nano in 1-, 2- or all 3 dimensions (a) layers; (b) rods; (c) particles Layers coatings and barrier properties Rods structural strength Particles more dispersible, bioavailable and potent

19 Nanomaterials - Risk assessment The EFSA risk assessment of nanomaterials used in FCMs is currently limited to two criteria: 1. Soluble is not in nanoform in food / simulants... but what means complete dissolution? 2. Does not migrate / is not detectable... but with no general threshold level of interest to guide the migration studies and the RA We lack the understanding to interpret any migration results what is a safe level?

20 Nanomaterials - Exposure The body of evidence thus far suggests that for well-designed FCMs the potential for NP migration is very low, if at all. analytical methods are moving from infancy towards maturity? questions on the adequacy of simulating systems hope to have some measured data to support the migration modelling that is used

21 Nanomaterials - Further Reading (a shameless advert.....) Nanotechnologies in Food RSC Nanoscience & Nanotechnology Series Edited by Qasim Chaudhry, Laurence Castle & Richard Watkins. Royal Society of Chemistry (Cambridge, UK). Second Edition, Chapter 7. Nanotechnology in Food Packaging. Susana Addo Ntim and Gregory O. Noonan (US-FDA) Chapter 8. Nanomaterials in food products: a new analytical challenge. Timothy V. Duncan (US-FDA) and Gurmit Singh (Health Canada)

22 Recent Progress in the Risk Assessment of FCMs TOPICS: 2016 EFSA opinion on FCM 2016 EFSA-WHO Review of the TTC Considerations of Nano Considerations of Gentox New (2016) EFSA WG on Mixtures

23 Considerations of genotoxicity For IAS, genotoxicity can be a knock-out blow. For NIAS, the TTC value for genotoxicity is a single fixed (and very low) exposure value. Can we see a future where genotoxicity is better understood and may be treated quantitatively?

24 Review of the TTC approach and development of new TTC decision tree. EFSA and WHO, March 2016

25 Genotoxicity as binary yes / no test Gene mutation in bacteria Typical test report summary: The substance XYZ was tested for mutagenicity in the Salmonella typhimurium strains TA98, TA100, TA1535, TA 1537 and TA1538 in triplicate using the standard plate incorporation assay with and without the addition of a metabolising system (S9 mix) obtained from Aroclor 1254 induced rats. The test substance was dissolved in Tween 80/water and appropriate positive (4-nitro-ophenylenediamine and aminoanthracene) and negative (Tween 80/water) controls were included. Test concentrations: 8, 40, 200, 1000 and 5000 µg/plate 625-fold span Note: If clearly positive results are obtained with the in vitro tests the in vivo follow up should be considered to determine whether the hazard is expressed in-vivo.

26 Genotoxicity as binary yes / no test In vitro mammalian cell gene mutation test Typical test report summary: The potential of substance XYZ to induce gene mutations at the mouse lymphoma kinase thymidine locus/tk+/- using the cell line L5178Y was assessed in the absence and presence of rat liver S9 mix (induced by phenobarbitol/β-naphtoflavone). The study was performed in two independent experiments. Solvent and negative control was DMSO. Positive controls were MMS in the absence of S9 and cyclophosphamide in the presence of S9. Colony sizing for small and large colonies were carried out. Test concentrations: 0.1, 0.3, 1, 3, 10, 33, 100 and 333 µg/ml 3330-fold span Note: If clearly positive results are obtained with the in vitro tests the in vivo follow up should be considered to determine whether the hazard is expressed in-vivo.

27 Considerations of genotoxicity For IAS, genotoxicity can be a knock-out blow. For NIAS, the TTC value for genotoxicity is a single fixed (and very low) exposure value. Can we see a future where genotoxicity is better understood and may be treated quantitatively? Questions of dose-response, potency, and the sensitivity of test methods, are especially important for NIAS and the evaluation of mixtures. - how to prove a negative; how good is good-enough (adequate).

28 Recent Progress in the Risk Assessment of FCMs TOPICS: 2016 EFSA opinion on FCM 2016 EFSA-WHO Review of the TTC Considerations of Nano Considerations of Gentox New (2016) EFSA WG on Mixtures

29 IAS and NIAS Mixtures The EFSA Note for Guidance describes 1. Defined substances - single substances 2. Defined mixtures - reproducible, limited number of components 3. Non-defined mixtures - varying composition ILSI document uses ECHA / EPA categories: 1. Well-defined substances of the ca. 900 substances listed in Annex I of the Regulation EU 10/2011, over 500 substances belong to this group. 2. Substances of unknown or variable composition, complex reaction products or biological materials: more than 300 such substances are included in Annex 1 of the Regulation EU 10/2011.

30 RA of NIAS mixtures 1,7-Octadiene, cross-linker, to be used in all kinds of polyolefins, EFSA Journal 2015;13(1):3979 A comparative migration test between LDPE made with and without the substance showed no qualitative difference between the two GC-MS chromatograms The GC-MS analysis gave complex chromatograms of oligomeric species, Complexity of the GC-MS fingerprints (unresolved substances) madde it virtually impossible to identify/quantify each and every substance. As the polyolefin oligomers and other reaction products containing the co-monomer are likely to strongly vary in amount and composition, depending on the polymerization and manufacturing process used, they were not evaluated by the Panel. Evaluation of these oligomers and reaction products should be conducted case by case by the business operator.

31 New: EFSA Project MixTox Harmonisation of risk assessment methodologies for human health and ecological risk assessment of combined exposure to multiple chemicals Public consultation on the terms of reference closes on 30 November 2016

32 EFSA Topics page on Mixtures EFSA activity MixTox will span

33 Recent Progress in the Risk Assessment of FCMs TOPICS: 2016 EFSA opinion on FCM 2016 EFSA-WHO Review of the TTC Considerations of Nano Considerations of Gentox New (2016) EFSA WG on Mixtures [ end ]

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