Materials and Articles in Contact with Food

Transcription

1 Materials and Articles in Contact with Food Emma Bradley Fera Science Ltd Date: July 2017, Version 1

2 Overview What is migration? Factors affecting migration Legislation How it all started EU legislation EFSA risk assessment

3 Overview Migration testing Specific and overall migration Screening and verification tests Why do we test? How do we test? Other aspects NIAS, nanoparticles, functional barrier Declaration of compliance and supporting documentation Correction factors Harmonised non-plastic FCMs Non-harmonised FCMs

4 Introduction

5 Chemical contaminants NRL FSA appointed Fera NRL for Chemical contaminants in 2008 Food contact materials Dioxins and PCBs Mycotoxins PAHs Trace elements Also some Vet Drugs & Pesticides functions VMD and CRD

6 What is migration?

7 Migration from food contact materials Packaging is beneficial Protects foodstuff from spoilage However the transfer of chemicals from packaging to food may have a negative impact on the quality and safety of the food No food contact material is completely inert Need to ensure the safety of these materials

8 What is migration? The mass transfer from an external source into food by sub-microscopic processes May impact food in two ways Food safety migration of harmful substances Food quality migration of substances which impart taint or odour

9 What is migration? Migration occurs from: Food packaging Materials and articles used in food manufacture, transport and storage Materials and articles used in food preparation and consumption

10 Factors affecting migration Migration is a diffusion and partitioning process that is dependent on: The nature of the food contact material (FCM) The nature and concentration of the migrating substance The nature of the foodstuff The nature, the extent and the type of contact between the food contact material/article and the foodstuff

11 The nature of the FCM Depiction of chemical migration from an impermeable material Packaging Food Impermeable materials: - glass & ceramics - metals & alloys x y z

12 The nature of the FCM Depiction of chemical migration from a permeable material Packaging Permeable materials: - plastics - rubber & silicone - coatings Food x y z

13 The nature of the FCM Depiction of chemical migration from a porous material

14 The nature of the substance Ingredients needed to make plastics Monomers and starting substances Catalysts Solvents and suspension media Additives Antioxidants, antistatics, antifogging, slip additives, plasticisers, heat stabilisers, nucleating agents, dyes and pigments

15 The nature of the substance Acrylonitrile ( >2000 substances ) Xylene

16 The nature of the substance Migration into food (mg/kg) Da additive 500 Da additive 1000 Da additive Time (days)

17 The nature of the foodstuff Migration (mg/dm 2 ) no fat 10% fat 20% fat 30% fat 50% fat Low fat = high caprolactam migration 0.5 High fat = low caprolactam migration Time (days)

18 The nature of the contact Interaction between food and packaging Direct versus indirect contact Point or continuous contact

19 The nature of the contact time and temperature MIgration (mg/kg) C 30 C 40 C Time (days)

20 Legislation

21 EU legislation (EC) No 2023/2006 Good Manufacturing Practice Framework Regulation (EC) No 1935/ /42/EC Regenerated cellulose film 84/500/EEC Ceramics, as amended 1895/2005/EC BADGE/BFDGE/ NOGE (EC) No 450/2009 Active and intelligent materials 93/11/EEC Nitrosamines and nitrosatable substances Plastics (EU) No 10/2011 Plastics Implementation Measure, as amended/corrected (EU) No 321/2011 restriction of use of Bisphenol A in plastic infant feeding bottles (EU) No 284/2011 polyamide and melamine plastic kitchenware (EC) No 282/2008 Recycled plastics Reproduced with the kind permission of Annette Schaefer (DG-SANCO, European Commission)

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23 Framework Regulation First step to harmonising legislation Defines what is meant by food contact materials and articles Two general principles Inertness Safety

24 Framework Regulation Article 3 Materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could: (a) endanger human health; (b) bring about an unacceptable change in the composition of the food; (c) bring about a deterioration in the organoleptic characteristics thereof.

25 Framework Regulation - labelling If an article is intended for food contact it shall be labelled for food contact or bear the symbol with a glass and fork Not obligatory where the intention for food contact is obvious by the nature of the article e.g. knife, fork, wine glass

26 Framework Regulation - labelling Labelling, advertising and presentation of food contact materials shall not mislead the consumer Instructions for safe use shall be provided Labelling can also act as a means of identification for product traceability

27 Framework Regulation - traceability The traceability should be ensured at all stages in order to facilitate control, the recall of defective products, consumer information and the attribution of responsibility

28 Framework Regulation specific measures Empowers the Commission to set requirements for specific materials or substances (1) Active and intelligent materials and articles (2) Adhesives (3) Ceramics (4) Cork (5) Rubbers (6) Glass (7) Ion-exchange resins (8) Metals and alloys (9) Paper and board (10) Plastics (11) Printing inks (12) Regenerated cellulose (13) Silicones (14) Textiles (15) Varnishes and coatings (16) Waxes (17) Wood

29 Framework Regulation Declaration of compliance Declaration of compliance (DoC) Framework Regulation 1935/2004 states: Materials and articles shall be accompanied by a written declaration stating that they comply with the rules applicable to them Appropriate documentation shall be made available to the enforcement authorities to demonstrate such compliance

30 EU legislation (EC) No 2023/2006 Good Manufacturing Practice Framework Regulation (EC) No 1935/ /42/EC Regenerated cellulose film 84/500/EEC Ceramics, as amended 1895/2005/EC BADGE/BFDGE/ NOGE (EC) No 450/2009 Active and intelligent materials 93/11/EEC Nitrosamines and nitrosatable substances Plastics (EU) No 10/2011 Plastics Implementation Measure, as amended/corrected (EU) No 321/2011 restriction of use of Bisphenol A in plastic infant feeding bottles (EU) No 284/2011 polyamide and melamine plastic kitchenware (EC) No 282/2008 Recycled plastics Reproduced with the kind permission of Annette Schaefer (DG-SANCO, European Commission)

31 Plastics First material type to be covered by specific measures Regulation (EU) No 10/2011 Consolidated legislation for plastic materials and articles Directive 2002/72/EC, as amended Directive 82/711/EEC, as amended Directive 85/572/EEC, as amended Directive 78/142/EEC

32 What does the Regulation cover? Materials and articles and parts thereof consisting exclusively of plastics Multi-layer plastic materials and articles held together by adhesive or other means Materials and articles referred to above that are printed and/or covered by a coating

33 What does the Regulation cover? Plastic layers or coatings forming gaskets in caps and closures that make a set of 2 or more layers of different types of materials Plastic layers in multi-material, multi-layer materials and articles

34 What rules does the Regulation set? Union List of authorised monomers and additives for use in the manufacture of plastics Restrictions and specification for authorised substances including specific migration limits Overall migration limit Rules on non-intentionally added substances (NIAS) Rules on compliance testing

35 What rules does the Regulation set? The functional barrier concept Authorisation of nano-materials before use Declaration of compliance and supporting documents

36 Union list Authorised monomers and additives Annex 1 to Regulation Means that only substances authorised at EU level may be used in the production of food contact plastics

37 Restrictions on substances Potential health risk may occur from non- or incompletely reacted monomers or other starting substances or from low molecular weight additives which are transferred into food via migration from the plastic food contact material Therefore monomers, other starting substances and additives should be risk assessed and authorised before their use in the manufacture of plastic materials and articles

38 Risk assessment The European Food Safety Authority (EFSA) Risk assessment should consider: The substance itself Any relevant impurities Any foreseeable reaction and degradation products The potential migration under worst foreseeable conditions of use The toxicity

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40 Risk management Based on the risk assessment the authorisation should if necessary set out specifications for the substance and restrictions of use, quantitative restrictions or migration limits to ensure the safety of the final material or article

41 Overall migration limit Inertness limit Does not cover volatile substances Expressed per food contact surface area = 10 mg/dm 2 For infant foods expressed per kg/food = 60 mg/kg

42 Specific migration limits Safety limit SML set out in Annex I If no SML specified in Annex I then 60 mg/kg SML related to food

43 Specific migration limits The EU SML s are based on toxicology and exposure However, pending a best estimation of exposure, the EU system is based on migration assuming that: 1 person of 60 kg ingest daily 1 kg of food in contact with 6 dm 2 of surface containing the substance at the maximum concentration permitted (SML)

44 Specific migration limits Dual use additives/flavourings No technical effect in food Lowest restriction applies for authorised food additives For non-authorised food additives/flavourings SML are applicable

45 Migration testing

46 Migration testing Rules defined to test for compliance of migration from food contact materials and articles Technical guidelines drafted

47 Testing strategies Regulation (EU) No 10/2011 states: Official control should establish testing strategies which allow the enforcement authorities to perform controls efficiently making best use of available resources. Therefore it should be admissible to use screening methods for checking compliance under certain conditions. Non-compliance of a material or article should be confirmed by a verification method.

48 Specific migration materials and articles already in contact with food Food removed from packaging before the expiry date or any date by which the manufacturer has indicated the product should be used for reasons of quality or safety If instructions are given then they should be followed Non-edible parts removed Analysis

49 Specific migration materials and articles already in contact with food Special cases Some substances are ubiquitous and their presence does not necessarily mean migration from the material or article Some migrants react with food components

50 Specific migration materials and articles not yet in contact with food Screening tests More severe Can be used to demonstrate compliance Simpler and cheaper Verification tests Can be used to demonstrate compliance or non-compliance Required for enforcement Foods worst foreseeable contact conditions Food simulants rules defined for conventional migration tests

51 Screening approaches Replacing specific migration by overall migration Residual content Migration modelling Food simulant substitutes

52 Replacing specific migration with overall migration For stable and non-volatile substances Overall migration test conditions must be at least as severe as those prescribed for specific migration Only applicable for substances with an SML greater than the analytical tolerance For Simulant D2 = 3 mg/dm 2, i.e. 18 mg/kg applying the conventional food contact ratio For aqueous simulants = 2 mg/dm 2, i.e. 12 mg/kg applying the conventional food contact ratio

53 Residual content Known from formulation information Demonstrate complete extraction Polymer dissolution and subsequent precipitation Successive solvent extraction Selection of extraction solvent dependent on both the polymer and the substance c p,0

54 Migration modelling Based on diffusion theory and a consideration of partitioning effects Diffusion coefficient of the migrant in the plastic (D P ) Partition coefficient of the migrant between the plastic and the food or food simulant (K P,F )

55 Migration modelling A number of commercial and freeware software packages are available to predict the extent of migration from the c p,0 value These models have been tuned to provide an overestimation of migration in the majority of cases so that they can be used with confidence in compliance testing

56 Food simulant substitutes To screen for specific migration, food simulants can be replaced by substitute food simulants if it is based on scientific evidence that the substitute food simulants overestimate migration compared to the regulated food simulants

57 Verification methods Migration into and analysis of food simulants The packaging can be tested for its suitability before use by employing food simulants that are intended to mimic the migration properties of different categories of foods Introduced in the early-1980 s along with the rules for using simulants Migration into and analysis of foods

58 Migration into food simulants Select simulant based on food type Select exposure type Select exposure conditions - time and temperature

59 Food simulants Simulant Ethanol 10% (v/v) Acetic acid 3% (w/v) Ethanol 20% (v/v) Ethanol 50% (v/v) Vegetable Oil Modified polyphenylene oxides, particle size mesh, pore size 200 nm Abbreviation Simulant A Simulant B Simulant C Simulant D1 Simulant D2 Simulant E for dry foods

60 Annex III general assignment Simulants A, B and C For foods with hydrophilic character Simulant B For foods with ph < 4.5 Simulant C Alcoholic foods with an alcohol content of up to 20% Foods with a relevant amount of organic ingredients that render the food more lipophilic

61 Annex III general assignment Simulants D1 and D2 For food with a lipophilic character Simulant D1 Alcoholic foods with an alcohol content of > 20% Foods containing oil in water emulsions Simulant D1 Foods with free fat at the surface Simulant E For dry foods

62 Annex III food category assignments Column 1 Column 2 Column 3 Reference number Description of food Mustard (except powdered mustard under heading 08.17) Simulants A B C D1 D2 E X X(*) X/3(**) (*) simulant B can be omitted if the food has a ph of more than 4.5 (**) the testing in simulant D2 can be omitted if it can be demonstrated by means of an appropriate test that there is no `fatty contact with the plastic food contact material 3 = Simulant D-Reduction factor

63 Which exposure types Total immersion Pouch Reverse pouch Article fill Migration cell

64 Test conditions for specific migration Conditions of contact in worst foreseeable use Test conditions Contact temperature Test temperature T 5 C 5 C 5 C < T 20 C 20 C 20 C < T 40 C 40 C 40 C < T 70 C 70 C 70 C < T 100 C 100 C or reflux temperature 100 C < T 121 C 121 C(*) 121 C < T 130 C 130 C (*) 130 C < T 150 C 150 C (*) 150 C < T < 175 C 175 C (*) T > 175 C Adjust the temperature to the real temperature at the interface with the food (*) (*) This temperature shall be used only for food simulants D2 and E. For applications heated under pressure migration testing under pressure at the relevant temperature may be performed. For food simulants A, B, C or D1 the test may be replaced by a test at 100 C or at reflux temperature for duration of four times the time selected according to the conditions in Table1.

65 Test conditions for specific migration Contact time in worst foreseeable use t 5 min Test time 5 min 5 min < t 0.5 hour 0.5 hour 0.5 hours < t 1 hour 1 hour 1 hour < t 2 hours 2 hours 2 hours < t 6 hours 6 hours 6 hours < t 24 hours 24 hours 1 day < t 3 days 3 days 3 days < t 30 days 10 days Above 30 days See specific conditions Specific conditions Alternative 1 Exp * (1/T1-1/T2) T1 frozen/cold 278 K (5 o C) T1 room temperature 298 K (25 o C) Alternative 2 Frozen: 10 days 20 o C Refrigerated: 10 days 40 o C RT/6 months: 10 days 50 o C RT all: 10 days 60 o C Alternative 3 Equilibrium at 10 days 40 o C

66 Special considerations Combinations of contact times and temperatures Subject the test specimen successively to all of the worst case conditions appropriate to the sample Using the same portion of food simulant

67 Special considerations Repeat use articles Three successive migration tests Compliance with the result obtained form the third exposure One exposure/test is sufficient if scientific proof that the migration does not increase and the migration limit is not exceeded For substances in Annex I that have an SML of not detectable then the first exposure/test result should be used

68 Overall migration limit Regulation (EU) No 10/2011 Plastic materials and articles shall not transfer their constituents to food simulants in quantities exceeding 10 mg/dm 2 of food contact surface Plastic materials and articles intended to be brought into contact with food intended for infants and young children, shall not transfer their constituents to food simulants in quantities exceeding 60 mg/kg of food simulant

69 Screening approaches overall migration Residual content of migratable substances Food simulant substitutes Scientific evidence that the food simulant substitutes overestimate migration compared to regulated food simulants

70 Standardised test conditions for overall migration Test Number Contact time at contact temperature Intended food contact conditions OM1 10 d at 20 o C Frozen, refrigerated OM2 10 d at 40 o C long term storage including short term heating OM3 2 h at 70 o C Short term heating OM4 1 h at 100 o C High temperature application OM5 OM6 2 h at 100 o C or at reflux or 1 h at 121 o C 4 h at 100 o C or at reflux High temperature applications up to 121 o C. Any food contact conditions with food simulants A, B or C, at temperature exceeding 40 o C. OM7 2 h at 175 o C High temperature applications with fatty foods

71 Substitute test for OM7 with food simulant D2 Test Number OM8 OM9 Contact time at contact temperature Food simulant E for 2 hours at 175 C and Food simulant D2 for 2 hours at 100 o C Food simulant E for 2 hours at 175 C and Food simulant D2 for 10 days at 40 o C Intended food contact conditions High temperature applications only High temperature applications including long term storage at room temperature In case it is technically NOT feasible to perform OM7 with food simulant D2 the test can be replaced by test OM8 or OM9

72 Food simulants for overall migration All foods Distilled water or water of equivalent quality or food simulant A Food simulant B Food simulant D2 shall be performed All foods except for acidic foods Distilled water or water of equivalent quality or food simulant A Food simulant D2

73 Food simulants for overall migration All aqueous and alcoholic foods and milk products Food simulant D1 All aqueous, acidic and alcoholic foods and milk products Food simulant D1 Food simulant B

74 Food simulants for overall migration All aqueous foods and alcoholic foods up to an alcohol content of 20% Food simulant C All aqueous and acidic foods and alcoholic foods up to an alcohol content of 20% Food simulant C Food simulant B

75 CEN overall migration methods Standard reference Title Plastics Materials and articles in contact with foodstuffs - Plastics - EN :2002 EN :2002 EN :2002 EN :2002 EN :2002 EN :2002 EN :2002 EN :2002 EN :2002 EN :2002 EN :2002 EN :2002 EN :2002 EN :2002 EN :2002 Part 1: Guide to the selection of conditions and test methods for overall migration Part 2: Test methods for overall migration into olive oil by total immersion Part 3: Test methods for overall migration into aqueous food simulants by total immersion Part 4: Test methods for overall migration into olive oil by cell Part 5: Test methods for overall migration into aqueous food simulants by cell Part 6: Test methods for overall migration into olive oil using a pouch Part 7: Test methods for overall migration into aqueous food simulants using a pouch Part 8: Test methods for overall migration into olive oil by article filling Part 9: Test methods for overall migration into aqueous food simulants by article filling Part 10: Test methods for overall migration into olive oil (modified method for use in cases where incomplete extraction of olive oil occurs) Part 11: Test methods for overall migration into mixtures of C-labelled synthetic triglycerides Part 12: Test methods for overall migration at low temperatures Part 13: Test methods for overall migration at high temperatures Part 14: Test methods for 'substitute tests' for overall migration from plastics intended to come into contact with fatty foodstuffs using test media iso-octane and 95 % ethanol Part 15: Alternative test methods to migration into fatty food simulants by rapid extraction into iso-octane and/or 95 % ethanol

76 Other aspects

77 What can migrate? Known ingredients such as monomers, catalysts, solvents, suspension media, additives etc. IAS Known or unknown isomers, impurities, reaction products and breakdown products of these ingredients Possible contaminants from manufacturing process Recycled materials Irradiated products Contamination from indirect sources such as printing inks, coatings, adhesives, secondary packaging NIAS

78 Targeted vs non-targeted analysis Specific extraction Clean-up Specific analysis Generic extraction Minimal clean-up Generic analysis Targeted Non-targeted IAS - Know exactly what to measure Predictable NIAS oligomers, impurities, literature references NIAS - Complete unknowns

79 Determination of NIAS GC-MS technologies EI Library comparisons Access to molecular species using CI source GC-QTOF-MS allows high resolution accurate mass data to be collected too LC-HR-MS technologies TOFs, QTOF, Orbitrap instruments Accurate mass, fragmentation, database comparisons Profiling

80 Profiling Differentiating between samples by detecting (and identifying) marker substances and requires: Experiments to be set-up to allow the collection of good quality data Accurate, precise, reproducible and robust methods Software to process the data e.g. MPP Filter and align peaks across the samples Filter the entities Principal component analysis Hierarchical cluster analysis Create prediction models

81 Mass balance: specific versus overall migration Comment: This is an unusually good case and the migration is dominated by plasticisers and additives and only a relatively small proportion (27%) remains unknown. Professor Thomas Simat, ILSI, 2008 Mass balance for a plastic laminate Evaluation of the total migrate (4h 60 o C, 95% EtOH) In some FCMs, more than 80% may be unknown or at least not-studied.

82 Can all NIAS be predicted? Prediction will never be complete: ppm or ppb concentrations means having to understand reaction pathways with e.g. only % yield Reactions may be energetically unfavourable, mechanistically complex, difficult or impossible to predict, and yet can be significant

83 Nanoparticles Nanoparticles Different toxicological properties Substances should be assessed on a case-by-case basis Risk assessment of the conventional particle size of a substance do not cover engineered nanoparticles Substances in nanoform shall only be used if explicitly authorised and mentioned in the specifications of Annex 1

84 Functional barrier A plastic layer which is separated from the food by a functional barrier may contain non-authorised substances provided: They are not mutagenic, carcinogenic, toxic to reproduction They are not in nanoform That any migration into food or food simulant is not detectable (using a method with a detection limit of < 10 ppb) Set-off must also be considered

85 Declaration of compliance A written declaration should be available for plastic materials and articles, products from intermediate stages of their manufacturing as well as for the substances intended for the manufacturing of those materials and articles Annex IV provides a list of the information that it is necessary to include in the declaration of compliance

86 Supporting documentation Appropriate documentation to demonstrate that the materials and articles, products from intermediate stages of their manufacturing as well as the substances intended for the manufacturing of those materials and articles comply Migration test results, calculations, modelling or other analysis Evidence on the safety or reasoning that the material or article is compliant

87 Correction factors - FRF Fat reduction factor Exposure to substances migrating from FCMs uses the conventional assumption that a person consumes daily 1 kg food However, a person ingests at most 200 g of fat on a daily basis Applies to lipophilic substances that only migrate into fat Migration test result is divided by the FRF before comparing with the migration limit The FRF is not applicable to Foods intended for infants and young children Materials for which the surface area to mass of food not known

88 Correction factors simulant D For fat containing foods the result obtained with food simulant may in certain cases significantly overestimate migration into food Simulant D reduction factor (DRF) DRF is given in the Annex 1 Migration test result is divided by the DRF before comparing with the migration limit

89 Correction factors Tool available from the EURL-FCM website

90 Technical guidelines Drafted by industry bodies, NRLs and individual experts Sampling Materials and articles already in contact with food or using food as a simulant testing for specific migration Verification of compliance with migration limits using food simulants Screening Analytical determination of migrants Reporting of the final migration test result

91 Amending Regulation (EU) 10/2011 Regulation (EU) No 321/2011, bans the use of bisphenol A (BPA) for the manufacture of polycarbonate infant feeding bottles

92 Regulation (EU) No 1282/2011, 1183/2012, 202/2014, 2015/174 Amend Regulation (EU) 10/2011 Recently the European Food Safety Authority (the Authority) issued favourable scientific evaluations for additional substances which should now be added to the current list. For certain other substances, the restrictions and/or specifications already established at the EU level should be amended on the basis of a new favourable scientific evaluation by the Authority. Adds new substances and amends restrictions and specifications of already authorised substances on the Union list

93 6 th Amendment to Regulation (EU) 10/2011 This draft will be presented for vote at the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) Toxicological section on 13 April 2016 As well as adding substances to the Union list, the amendment also includes changes to testing, e.g.: Repeat use testing for primary aromatic amine migration Defining conditions for which hot-fill testing is appropriate etc

94 BPA roadmap BPA roadmap _sante_534_bpa_measure_en.pdf Options No policy change Modify legislative restrictions for BPA in plastic food contact materials at EU level Modify legislative restrictions for BPA in plastic food contact materials at EU level and introduce measures for BPA in coatings and varnishes at EU level Modify legislative restrictions for BPA in plastic food contact materials at EU level and introduce measures for BPA in food contact coatings and varnishes as well as other food contact materials in which BPA may be present Ban on BPA in food contact materials at EU level

95 Regulation (EU) No 284/2011 Applicable to polyamide and melamine plastic kitchenware that falls under CN code ex Products originating in or consigned from China and Hong Kong are controlled Prior Notification The importer is required to notify Port Health of the estimated date and time of physical arrival of the consignment 2 working days in advance

96 Regulation (EU) No 284/2011 Checks on Imports Documentary checks on 100% of consignments Identity and physical checks (including laboratory analysis) on 10% of consignments (selected at random) Primary aromatic amine release from nylon kitchenware Formaldehyde release from melamine-ware

97 Recycled Plastic FCMs Regulation (EU) No 282/2008 Aim Ensure compliance with Article 3 of Regulation 1935/2004 Critical control point is the recycling process Scope All mechanically recycled plastic for FCM placed on EU market originating from recyclers in EU and third countries Not chemical recycling or recycled plastics behind a functional barrier

98 Recycled plastic FCMs Individual authorisation of recycling processes - EFSA Quality of input Efficiency of the process to sort input and reduce contaminants Restrictions on the application of recyclate Requirements on quality assurance system in GMP DoC required and voluntary labelling

99 EU legislation non-plastics (EC) No 2023/2006 Good Manufacturing Practice Framework Regulation (EC) No 1935/ /42/EC Regenerated cellulose film 84/500/EEC Ceramics, as amended 1895/2005/EC BADGE/BFDGE/ NOGE (EC) No 450/2009 Active and intelligent materials 93/11/EEC Nitrosamines and nitrosatable substances Plastics (EU) No 10/2011 Plastics Implementation Measure, as amended/corrected (EU) No 321/2011 restriction of use of Bisphenol A in plastic infant feeding bottles (EU) No 284/2011 polyamide and melamine plastic kitchenware (EC) No 282/2008 Recycled plastics Reproduced with the kind permission of Annette Schaefer (DG-SANCO, European Commission)

100 Ceramics COUNCIL DIRECTIVE (84/500/EEC) migration of lead (Pb) and cadmium (Cd) into food contact ceramic articles Current limits for fillable articles Lead 4.0 mg/l Cadmium 0.3 mg/l Where does the Pb and Cd come from? Cadmium Bright colours Lead Glaze

101 Ceramics EFSA Opinions on Pb and Cd Exposure should be reduced 2011 Problem definition and initial discussion with EU Member States 2012 Discussion on values that derive from the risk assessment Lead 10 µg/kg Cadmium 5 µg/kg

102 Ceramics Which elements? Which simulant(s)? Which test conditions?

103 Comparing migration Concentration (µg/dm 2 ) Cadmium Tomato sauce Acetic acid Citric acid Pre-conditioning Exposure number

104 Ceramics migration testing Migration was found to be sample and element dependent don t always observe the same trend Effect of pigment position under-, in- or on-glaze? Effect of repeated use in the home?

105 Ceramics migration testing Technical problems with exposures at elevated temperature (handling hot acid, loss of simulant through evaporation) Testing regime must be pragmatic whilst at the same time protecting the user Time - pre-conditioning resulted (in general) in a higher migration in the third exposure

106 Non-harmonised FCMs Roadmap published July 2012 Context: problem definition Objectives Options Initial assessment of impacts Evidence base, planning, consultation

107 What are the options? No action at EU level leaving Member States to set up specific requirements at national level Establishment of lists of substances, materials or processes used together with migration limits Negative lists of substances not to be used in FCM

108 What are the options? Setting out obligations and criteria for risk assessment of substances and/or materials Setting out obligations and criteria for information exchange throughout the manufacturing chain via declaration of compliance and supporting documentation Setting out detailed material specific rules on good manufacturing practice

109 Non-harmonised FCMs terials/non_harmonised/index_en.htm

110 Useful links DG SANCO ntact/index_en.htm EFSA EURL

111 Tel: +44 (0)