Risk Assessment and FCMs the Role of EFSA

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1 Risk Assessment and FCMs the Role of EFSA Eugenia Lampi State General Chemical Laboratory, Greece TAIEX -Workshop on materials and articles intended to come into contact with food November 2014, Belgrade, Serbia

2 CONTENT OF PRESENTATION EFSA s mission and way of working CEF Panel The assessment of FCMs Legal background Substances used in FCMs under plastics regulation EC 10/2011 Note for Guidance EFSA Guidelines A&I Substances used in FCMs under EC 450/2009 EFSA Guidelines Recycled plastics used in FCMs under EC 282/2008 EFSA Guidelines EFSA Criteria

3 WHAT IS EFSA? European Food Safety Authority The European reference body Covers the entire food chain Assess, advise, communicate Independent, trusted, based on sound science

4 EFSA S ORIGINS Formally set up in January 2002 as an independent source of scientific advice and communication on risks associated with the food chain (REGULATION (EC) No 178/2002 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 28 January2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety) Created as part of a comprehensive programme to: improve EU food safety help ensure a high level of consumer protection restore and maintain confidence in the EU food supply.

5 ABOUT EFSA Set up in 2002 Moved to Parma 2005 EFSA started its scientific work in 2003 Budget 2013 of 78 Million Euros Over 450 Staff, 60% engaged in science Since 2003 more than 3300 scientific outputs including 2330 scientific opinions

6 WHAT EFSA DOES? Provide independent scientific advice and support for EU law/policies on food and feed safety Provide independent risk communication Promote scientific cooperation Networking Monitoring

7 WHAT EFSA CANNOT DO Enforce food safety legislation Take charge of food safety/quality controls, labelling or other such issues Substitute for national authorities

8 HOW DOES EFSA WORK? European Commission European Parliament Member States EFSA ( self mandate ) Risk Assessment

9 10 SCIENTIFIC PANELS AND SCIENTIFIC COMMITTEE

10 CEF Panel

11 CEF PANEL: MANDATE Panel on food contact materials, enzymes, flavourings and processing aids (CEF) the safety of use of materials in contact with food, enzymes, flavourings and processing aids, safety of processes (MB Decision Establishment and Operations of Scientific Committee, Scientific Panels & working groups MB and Art. 28 (4) Regulation 178/2002)

12 CEF PANEL: WORK AREAS Flavourings Smoke flavourings Re-evaluation programme, union list but pending additional data submission on subgroups of FGEs (mainly genotoxicity or 90-day toxicity data) New flavouring applications Food contact materials Substances [plastics (mainly) and non-plastics] Active and intelligent packaging Recycling of plastic materials processes Food enzymes New activity including GM assessment: submission of dossiers by industry possible until March 2015; many applications are currently under evaluation. Processing aids

13 MEMBERS OF THE CEF PANEL Chair: Prof. Vittorio Silano (IT) Vice-chairs: Dr. Wim Mennes (NL) Dr. Detlef Wölfle (DE) 19 Panel members More information about the CEF experts

14 The Assessment of FCMs

15 FOOD CONTACT MATERIALS LEGAL FRAMEWORK FCM framework Regulation (EU) 1935/2004 When a list of substances is adopted, anyone seeking an authorisation for a substance not yet included in that list shall submit an application EFSA shall give an opinion on the safety assessment of the substance Lays down workflow and makes reference to guidelines for the safety assessment by EFSA Guidelines of the Scientific Committee on Food for the presentation of an application for safety assessment of a substance to be used in food contact materials prior to its authorisation (SCF Guidelines). 15

16 Substances used in FCMs

17 SCOPE Substances used in plastics under Regulation EC 10/ Monolayer Plastics - Multilayer materials and articles from plastics Substances used in other FCMs - Coatings - Elastomers 17

18 CATEGORIES OF SUBSTANCES According to specific use - Monomers, co-monomers, starting substances - Additives - Polymerization production aids (PPAs) Acoording to chemical identity - Individual substances - Defined mixtures of substances - Non defined mixtures of substances - Polymers used as additives 18

19 NOTE FOR GUIDANCE FOR FOOD CONTACT MATERIALS Compilation of documents - Guidance for applicants to present an application for the assessment of substances used in FCMs - Last update in 2008 The documents - Administrative Guidance - Chapter I - SCF Guidelines - Chapter II - AFC-FCM-WG Explanatory Guidance - Chapter III - Commission Explanatory Guidance - Chapter IV 19

20 NOTE FOR GUIDANCE FOR FOOD CONTACT MATERIALS Available in-line at: 20

21 NOTE FOR GUIDANCE FOR FOOD CONTACT MATERIALS The aim is to provide: - Guidelines for presentation of an application for the safety assessment of a substance prior and subsequent inclusion in the Reg. - Guidelines for the submission of the dossiers accompanying such requests. - Explanations on the criteria used by the CEF Panel 21

22 OVERVIEW OF DATA TO BE SUPPLIED - Non toxicological chemical data - Microbiological data (biocides) - Toxicological data - Data on authorization 22

23 NON TOXICOLOGICAL (CHEMICAL) DATA Identity: - Molecular weight, formula, synonyms e.t.c. spectroscopic data for identification, purity, manufacturing details, constituents - Purity, impurities with relevant methods. - Specifications 23

24 NON TOXICOLOGICAL (CHEMICAL) DATA Physical and chemical properties: - Boiling, meting points, thermal stability, decompositino temperature - Solubility, octanol/water partition (logpo/w)- lipophilicity, hydrolysis - Decomposition, reaction with foodstufs 24

25 NON TOXICOLOGICAL (CHEMICAL) DATA Intended application of use: - Types of materials, e.g. type of polymers (POs, PET, PA e.t.c.) including types of articles if specific use is foreseen, percentage of use, maximum temperature of use - Technological action, e.g. antioxidant, antistatic agent, preservative, etc. - Types of foods in contact, conditions of use, specific uses (e.g. gaskets) 25

26 NON TOXICOLOGICAL (CHEMICAL) DATA Data on overall cific migration: - Types of polymers and intended content of the substance (worst case), dimensions of the sample - Food simulants (intended use should be taken into account), simulation conditions (T, t), according to Annexes III and V of EC 10/2011, surface to volume (general uses the conventional 6dm 2 /Kg applies specific uses) - Overall migration: EN standards (standard cell, total immersion, filling) 26

27 NON TOXICOLOGICAL (CHEMICAL) DATA Data on specific migration (substance, breakdown and reaction products, oligomers): - Relevant validated method should be used and provided with appropriate analytical characteristics in CEN format. This method is available to enforcement laboratories for control purposes - All analytical performance characteristics should be provided (recovery, precision, LOD, LOQ) - All methodologies, instruments, relevant conditions and analytical data are necessary to be provided 27

28 NON TOXICOLOGICAL (CHEMICAL) DATA Data on specific migration (substance, breakdown and reaction products, oligomers): - Results in all simulants tested in appropriate units (mg/kg food) taking into account the specific uses - Specific migration experiments can be replaced by recognized migration modeling software usi the appropriate Ap and τα values - Worst case migration can be used based on the result of residual content. 28

29 NON TOXICOLOGICAL (CHEMICAL) DATA Data on residual content (additives, monomers): - The same requirements on validated method, as in specific migration, are applied - The result can be used in modeling calculations - The worst case migration based on total transfer can be calculated 29

30 MICROBIOLOGICAL DATA Microbiological properties: - Intended microbiological function (e.g. during processing or storage), intended use - Way of action accompanied by appropriate data, spectrum and level of microbiological activity, efficacy - Consequences of use, demonstration on lack of effects on food microbia 30

31 TOXICOLOGICAL DATA SCF GUIDELINES SCF Guidelines (2001) provide the context for the information required: - In order to assess the human risk from the consumption of migrating substances from FCMs into foods. - The required information depends on the level of migration and exposure level. - However restricted information on exposure to FCMs migrating substances was available when guidelines were established. Therefore assumptions were used. 31

32 SAFETY EVALUATION = RISK ASSESSMENT Risk assessment steps HAZARD IDENTIFICATION EXPOSURE ASSESSMENT Occurrence in food Food consumption dietary EXPOSURE in EU (flavourings/fcm/slightly different approach) Relevant food groups, adults and specific groups of the population, HAZARD CHARACTERISATION Toxicokinetic (ADME), acute/sub/chronic toxicity, human data, genotoxicity, mode/mechanism of action, doseresponse for critical effect, POD, derivation of a health based guidance value (e.g ADI) RISK CHARACTERIZATION Relating exposure to health-based guidance value Vulnerable groups (children high level consumers) 32

33 PRINCIPLE FOR TOX DATA REQUIREMENT The higher the migration into food, the greater the amount of data is required Migration (mg/kg food) < Genotoxicity day study + + Accumulation info. + + ADME + Reproduction study + Developmental studies + Long term study + 33

34 ESTIMATION OF SPECIFIC MIGRATION LIMITS Results of toxicological experiments (e.g. NOEAL, TDI) A person (60 kg bw) consumes daily and throughout the whole life-time, up to 1 kg food (17 g/kg bw), packaged in 6 dm 2 of the same FCM type always containing substance in question at the highest permitted level Use of data on migration into food or food simulants under testing conditions according to Reg. (EU)10/2011 and uses requested 34

35 EFSA: FURTHER CONSIDERATIONS Consumption by infants & children is expected to be higher than of adults - Highest potential intakes of semicarbazide are in infants consuming ready-to-feed infant milk and baby food, due to the larger gasket areas and small b.w. (AFC, 2003, 2005) - Fat consumption by infants & children expected to be higher than adults by bw; Fat Reduction Factor will not be applicable to a number of the foods they consume (AFC Panel, 2004) - Soybean oil, epoxidised (ESBO) in PVC gasket: recommended to develop a specific migration limit in baby foods (AFC Panel, 2004) - Phthalates, BPA 35

36 REVISION OF SCF GUIDELINES (STARTED 2011) To ensure that specific and sensitive populations such as infants and toddlers are sufficiently covered Food consumption data are avalable now (some member states and a european project) To align with new EFSA positions (TTC, Nanomaterials, genotoxicity) To harmonise with other areas under the CEF Panel remit To have a more robust scientific basis for the safety assessment 36

37 Active and Intelligent Substances used in FCMs under EC 450/2009

38 SAFETY EVALUATION OF A&I SUBSTANCES Commission Regulation 450/2009: - Recital (10) The safety assessment of a substance or of a combination of substances which constitutes the components should be carried out by the European Food Safety Authority (the Authority), after the submission of a valid application, in accordance with Articles 9 and 10 of Regulation (EC) No 1935/ Article 9 states specific requirements for the timetable and the role of EFSA fro the authorization of A&I substances 38

39 EFSA A&I GUIDELINES (2009) Available at: 39

40 SAFETY EVALUATION OF A&I SUBSTANCES/EFSA GUIDELINES Main sections: - General principles of safety assessment focusing on the risk related to the dietary exposure to chemicals due to: o the migration of the active and/or intelligent substance(s) o the migration of their degradation and/or reaction products o their toxicological properties - Administrative for applications submission - Information to be supplied with an application 40

41 DATA TO BE SUPPLIED Overview of the application: - Concise presentation of the composition including passive parts, structure and working principle Identity of the substance(s) Physical and chemical characteristics Manufacturing process Intended use Existing authorizations Migration data Toxicological data 41

42 DATA TO BE SUPPLIED Context of data required: - The requirements of FCM substances risk assessment are applied with regard to details, analytical data, validation, migration, toxicological experiments required - Passive parts are excluded from the evaluation - Efficacy and most importantly any technical parameters and restrictions needed to ensure efficacy will be considered only when relevant for safety evaluation. The EFSA evaluation can not be considered as proof of the technical efficacy of active and/or intelligent material and article. 42

43 Recycled plastics used in FCMs EC 282/2008 Safety evaluation of mechanical recycling processes

44 SCOPE OF ASSESSMENT Safety evaluation of mechanical recycling processes to produce plastics intended to be in contact with foodstuffs Commission Regulation 282/2008: - Recital (19) A safety assessment of the recycling process should be carried out by the European Food Safety Authority ( the Authority ). In order to inform the applicant of the data to be provided for the safety assessment, the Authority should publish detailed guidance concerning the preparation and the submission of the application - Article 5 states specific requirements for the timetable and the role of EFSA for the authorization of mechanical recycling processes 44

45 EFSA RECYCLING PROCESS GUIDELINES (2008) Available at: 45

46 EFSA RECYCLING GUIDELINES General principles for the safety assessment: main risks related to recycled plastics: - Contaminants of the input material (presence of non food contact materials, incidental contamination form revous uses including misuse - Chemicals used in the recycling process e.g. detergents - Degradation products of the polymers or the plastic additives 46

47 EFSA RECYCLING GUIDELINES Technical data to be supplied: - Description of the recycling process or technology: detailed data for all steps from the input to the final recycled material including technological/operational details, process conditions, critical parameters (temperature,/operative pressure, time, gas flow), critical values and tolerance, appropriate flow chart. Technological and operational details and critical values are available to member states for control purposes - Description of the input including origin (kerbside, deposit systems), type of articles, specifications of washed flakes after grinding, percentage of non food contact articles 47

48 EFSA RECYCLING GUIDELINES Technical data to be supplied: - Determination of the decontamination efficiency of the recycling process or technology (specifically in case of non closed loop). An appropriate challenge test shall be performed at plant or pilot (or lab) level, using a wide range of surrogates with different molecular weight and polarity representative of all possible contaminants of concern. Spike levels may be several orders of magnitude higher than realistic concentrations of contaminants. Sets of surrogates have been proposed in the literature, depending on the polymer and on its intended uses. The conditions shall be the same as in the real plant. The process shall have such an efficiency to eliminate the surrogates in a level not differing for virgin plastic 48

49 EFSA RECYCLING GUIDELINES Technical data to be supplied: - Characterization of the recycled plastic. Data showing that the output is suitable for FCM production - Intended applications in contact with food - Compliance with the relevant provisions on FCMs - Process analysis and evaluation. Applicants shall perform their own risk analysis and safety conclusions based on the data provided - Quality assurance system related to product safety 49

50 EFSA PET CRITERIA Criteria for safety evaluation of recycling processes to produce recycled Polyethylene Terephthalate (PET) intended to be used for manufacture of FCMs - The majority of the applications to EFSA relate to rycicling of PET - The CEF Panel developed specific criteria for this type of plastics - Application of the cleaning efficiency of a recycling technology or process to a reference contamination level for post consumer PET. The resulting residual concentration in recycled PET (Cres) is then compared to a modeled concentration in PET (Cmod) 50

51 EFSA RECYCLING PROCESS GUIDELINES (2008) Available at: 51

52 EFSA PET CRITERIA Key parameters - Reference contamination of the input material (Cres). The data from the EU project FAIR CT and relevant scientific literature was used. Te likelihood of contamination from previous use and misuse of PET, non food contact (in case of PET the same composition is clarified) and presence of other materials as well as data on sorption of chemicals into PET were considered: 3mg/kg - Representativeness of the challenge test. Artificial contamination of the input should be at the appropriate level. Cross contamination issues should taken into account. 52

53 EFSA PET CRITERIA Key parameters - Modeled concentration in PET (Cmod). Based on the principle that taking into account the toxicity of the possible contaminants of PET the potential dietary exposure cannot be higher than μg/kg bw/day. - Modeling is applied to the migrations corresponding to the above exposure level (adults=0.75μg/kg, toddlers=0.15μg/kg, infants=0.1μg/kg) in order to calculate the respective Cmod - Efficient process or technology Cres < Cmod 53

54 ACKNOWLEDGMENTS Special thanks to Dr Georges Kass, Deputy Head of the Food Ingredients & Packaging Unit for the valuable help to prepare this presentation 54

55 Thank you very much for your attention

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