Update Regulations of Food Packaging Safety in EU Markets

Transcription

1 Update Regulations of Food Packaging Safety in EU Markets, Chinawat Tongchat, Thailand

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3 Principle of EU & national legislation EU level National level Addition legislation EU Directive Implemented EU directive EU Regulation 3

4 REGULATION (EC) No 1935/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC Scope of food contact materials Materials already in contact with food Materials intended for food contact Materials that can reasonably expected to come in contact with food Food packaging Food producing machinery Kitchenware Tableware Work surfaces in food preparation areas 4

5 Regulate 17 types of food contact materials Plastics Regenerated cellulose Elastomers and rubber Paper and boards Ceramics Glass Metal and alloys Woods Textiles Waxes Active materials and articles Adhesives Cork Ion-exchange resins Printing inks Silicones Varnishes and coating 5

6 Rules applicable to all FCM General requirements and definitions Do not endanger human health Do not change composition of the food in unacceptable way Do not mislead the consumer Be manufactured according to good manufacturing practice Traceability Labelling 6

7 Marks for safety of food packaging in EU 7

8 Overview of legislation 8 8

9 Rules applicable to all FCM (cont.) Quality assurance system Suitability of the starting materials Processes design and operation Premises and equipment Qualification of staff Documentation Quality control At all manufacturing stages except starting materials Regulation on Good Manufacturing Practice (EC) 2032/2006 9

10 Regulatory approach for FCM 10 10

11 EU Regulation (EC) No.1935/

12 EU Regulation (EC) No.1935/2004 (update 08/02/2012) 12

13 Application and transitions of regulation (EU) No 10/2011 May 2011 General rules and Union list Repeal of 2002/72/EC Repeal of vinyl chloride monomer testing Migration rules for testing in food Screening testing 2013 New Migration testing rules in simulants for enforcement Amendment of Directive 85/572/EEC 2016 Supporting documentation has to be based on the new migration testing rules Additive list fully applies to plastics and coatings forming gaskets in lids Additives in film formers for glass fibre reinforced plastics 13

14 EU plastic regulation (No. 10/2011) Scope and subject Specific measure for plastics Exclusively plastics Plastic multilayers bound by adhesives Plastic layers, coatings forming gaskets Plastic layers in multi-materials All plastics can be coated and/or printed 14

15 EU plastic regulation (No. 10/2011) Remain covered by national legislation Adhesives Printing Inks Coatings Clearly excluded from scope (as definition on plastics could also cover these) Ion-exchange resins Rubber Silicones 15

16 Plastic regulation (10/2011) Migration testing 16

17 Migration testing In food or in food simulants Update on food simulants Update on testing times and temperatures Screening tests Test for verification 17

18 Overall migration limit (OML) Inertness limit 10 mg/dm 2 Only in food simulants A-D (Annex III No. 10/2011) Does not cover volatile substances Expressed per food contact surface area 7 standardized test conditions (10/2011) 18

19 The EU Cube Model Conventional model: 1 kg packaged food per 60 kg person per day Edge lengths: 10 cm (=1dm) Volume: 1 l Density of the foodstuff: 1 kg/l 10 mg/dm 2 film correlates to 60 mg/kg foodstuff 19

20 Directive 2002/72/EC Restrictions based on following assumption Person of 60 kg consumes everyday during lifetime kg of foodstuffs always in contact with plastic always containing substance at maximum permitted quantity System is conventional and considered very restrictive 20

21 Regulation No 10/2011 For small packaging the surface to volume ratio is higher the resulting migration into food is higher For infants and small children have a higher consumption of food per kilogram bodyweight than adults and do not yet have a diversified nutrition 21

22 List of food simulants Annex III EU regulation no. 10/2011 (hydrophilic) (hydrophilic, ph<4.5) (hydrophilic, 20% alcohol) (Lipophilic, oil in water emulsion) (Food contain free fat at the surface) (Dry food) 22

23 Lipophilic food & Hydrophilic food Lipophilic food -soluble in fat Hydrophilic food - dissolving in water 23

24 Regulation No 10/2011 กรณ ของ caps, gaskets, stoppers Migration แสดงเป นหน วย ม ลล กร มต อก โลกร ม สำหร บอำหำรท บรรจ หร อต อพ นท ผ วท ส มผ สก บอำหำร ถ ำไม ทรำบว ำจะนำไปบรรจ ก บภำชนะขนำดใด ให ใช หน วยเป น ม ลล กร มต อขนำดภำชนะ 24

25 Example 25

26 Case of the jars: data for OML 26

27 7 standardised test conditions Annex V - EU regulation no. 10/

28 Specific migration limits (SML) Safety limit SML set out in Annex I (10/2011) If no SML specified in Annex I then 60 mg/kg SML related to food 28

29 Union list of authorised substances Annex I Table 1 (10/2011) 29

30 SML & SML(T) SML ของ Bisphenol A: 0.6 mg/kg SML(T) ของ Plasticizers ในอำหำรท บรรจ ในขวดแก วท ม ฝำ โลหะท ประกอบด วยปะเก นพลำสต กชน ด PVC Plasticizers ได แก ESBO, DINCH, ATBC, DBS เป นต น รวมก น ไม เก น 60 mg/kg 30

31 Group restriction of substances Annex I Table 2 (10/2011) 31

32 Plastics : Specific requirements Regulation 10/

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34 Time and temperature for Specific migration testing Contact time Contact temperature Annex V Table 1 & 2 (10/2011) 34

35 Specific condition for contact time above 30 days at room temperature and below t 2 = t 1 *Exp((-Ea/R)*(1/T1-1/T2)) Ea: worst case activation energy 80 kj/mol R: 8.31 J/Kelvin/mol Exp: -9627*(1/T1-1/T2) t 1 : contact time t 2 : testing time T1: contact temperature in Kelvin [For the room temperature storage this is set as at 298 K (25 C). For refrigerated and frozen condition it is set as 178 K (5 C)] T2: testing temperature in Kelvin 35

36 Regulation (EU) No. 10/2011 Annex V Testing for specific migration: Time/Temperature Time/ Temperature Standard conditions Testing for 10 days at 20 C shall cover all storage times at frozen condition. Testing for 10 days at 40 C shall cover all storage times at refrigerated and frozen conditions including heating up to 70 C/2 h, heating up to 100 C /15 min. Testing for 10 days at 50 C shall cover all storage time at refrigerated and frozen conditions including heating up to 70 C/2 h, or heating up to 100 C /15 min and storage times of up to 6 months at room temperature. Testing for 10 days at 60 C shall cover long term storage above 6 months /room temperature and below including heating up to 70 C/ 2 h, or heating up to 100 C/15 min 36

37 Specific condition for long term storage Regulation No.10/2011 Any time frozen Any time refrigerated and frozen conditions including heating Any time refrigerated and frozen conditions including heating and storage at room temperature ( half year) Any time at room temperature (>half year) 10 days at 20 C 10 days at 40 C 10 days at 50 C 10 days at 60 C 37

38 Regulation No.10/2011 สำร Nanoform ห ำมใช จนกว ำจะได ร บอน ญำต Dual use additive- food additive และ additive ของพลำสต กหร อ สำรแต งกล นรส ต องม นใจว ำต องไม ปลดปล อยสำรท เปล ยนแปลง ส วนประกอบของอำหำรจนไม ยอมร บ และไม ม ผลต อหน ำท ทำงเทคน ค ยกเว นเป นหน ำท ท ต งใจให เก ดและ FCM เป นไปตำม Regulation No.1935/2004 Regulation (EC) No.1333/ food additive Regulation (EC) No.1334/ flavourings and certain food ingredients with flavouring properties for use in and on foods 38

39 Clarification on status of substances in nanoform Substances in nanoform can only be used when they have been subject to risk assessment and authorisation in this form. Substances that had been subject to risk assessment in nanoform SiO 2 Carbon black TiN Definition on nano will follow Definition for novel foods or Generally agreed Commission definition 39

40 Regulation No.10/2011 Multi-material multi-layer material or article, the composition of each plastic layer shall comply with this Regulation Multi-material multi-layer material which is not in direct contact which food and is separated from the food by a functional barrier 40

41 Regulation No.10/2011 Multilayer plastic ม ช นท แยกอำหำรจำก functional barrier Functional barrier ม เพ อป องก นไม ให สำรเคล อนย ำยหล ง barrier ลงส อำหำร สำมำรถใช สำรท non - authorised หล งช น Functional barrier ได ถ ำ สำรน นเคล อนย ำยในปร มำณไม เก น 0.01 มก/กก ยกเว นสำรท เป น carcinogen, mutagenic, toxic to reproduction (CMR) 41

42 Substances not included in the union list Authoristed but not listed Colorants have to comply with Article 3 of 1935/2044 and national law Solvents to comply with Article 3 of 1935/2044 and national law Polymer production aids are listed but others can be used in accordance with national law and risk assessment by the manufacturer 42

43 Substances not included in the union list Present in the product and covered by the self-responsibility of manufacturer Non-intentionally added substances (NIAS) o Impurities o Reaction intermediate o Decomposition or reaction product Aids to polymerisation examples will be included in the guidance document Risk assessment by the manufacturer based on internationally accepted risk assessment models includes hazard assessment and exposure assessment 43

44 NIAS Non Intentionally Added Substances Impurities in the starting substances Degradation products Reaction products Oligomers The NIAS added to the non-evaluated starting substances means that different approaches to risk assessment and risk management must be considered. 44

45 NIAS Non Intentionally Added Substances To evaluate the other (non-plastic) materials more efficiently and to deal with the NIAS it is suggested: revisit the 10 ppb (ND), 50 ppb, 5 ppm and 60 ppm migration thresholds used. need the analytical methods and the exposure estimates to make it work 45

46 NIAS Non Intentionally Added Substances Potentially 10,000s of migrant chemicals may be found in food, incl. NIASs. Specific chemical-by-chemical regulation of all migrants in food not effective. Detailed scientific assessment of all would be enormous task. 46

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51 Regulation No.10/2011 Polymer production aids (PPA)ท ใช ในกระบวนกำรผล ต ย งไม ได ประเม น ต องประเม นในระด บประเทศ Impurities non - intentionally adds (NIAS) ท เก ดในกระบวนกำรผล ต ย งไม ได อย ในEU list สำรท ใช เป น catalysts ในกระบวนกำรผล ตพลำสต กจะไม ประเม นควำมเส ยง ในระด บ EU แต จะต องดำเน นกำรโดยผ ผล ตซ งต องเป น internationally recognized scientific principles on risk assessment 51

52 Regulation No.10/2011 Overall migration limit (OML) = 10 mg/6 dm 2, มำจำก Cube model = 60 mg/ 1 kg ของอำหำร สำหร บภำชนะบรรจ อำหำรขนำดเล กมำกหร อใหญ มำก อ ตรำส วนน อำจเป นไป ไม ได ต องม กำรปร บ (normalized) ในกรณ ของทำรกและเด กท ม กำรบร โภคอำหำรต อก โลกร มมำกกว ำต องกำหนด เกณฑ ต ออำหำรไม ใช พ นท ผ ว 52

53 Declaration of compliance (DoC) 53

54 EU Regulation (EC )1935/2004 Art Traceability The traceability of materials and articles shall be ensured at all stages in order to facilitate: Control- the recall of defective products consumer information and the attribution of responsibility The business operators (BOs) - have in place systems and procedures to allow the following: Identification from to which materials are supplied Identification of substances or products and its implementing measures used in their manufacture That information made available to the competent authorities on demand. 54

55 Traceability requirements The materials and articles, which are placed on the market in the community, shall be identifiable by an appropriate system, which allows Their traceability by means of labelling or relevant declaration of compliance and documentation or information. Traceability in the area of plastic food contact materials and articles is very complex. 55

56 Traceability information The BO-s should provide the following information from production of raw materials to supplier: the lot number of raw materials used in the production the date in which each single step of the production had been carried out plant and manufacturing line identification other information related to Quality Control 56

57 FBO-s responsibilities The responsible food business operators should: a) be able to identify from whom and to whom a product has been supplied b) have systems and procedures in place that allow for this information to be made available to the competent authorities upon their request. 57

58 FBO-s responsibilities The requirement relies on the one step back-one step forward approach which implies for food business operators that: a) They shall have in place a system enabling them to identify the immediate supplier (s) and immediate customer (s) of their products b) A link supplier-product shall be established (which products supplied from which suppliers) c) A link customer-product shall be established (which products supplied to which customers) 58

59 Declaration of compliance (DoC) and supporting documents (SD) Aim DoC information exchange on compliance throughout the manufacturing chain SD in-house documents on which the DoC is based Applicability Whole FCM production chain o final article o intermediate stages o up to the starting substances Adequate Information for non-plastic parts adhesives, printing inks, coating 59

60 Declaration of compliance (DoC) and supporting documents (SD) Information in supply chain Applies for the plastic food contact material production chain Applies to the final article but also intermediate stages up to the starting substances Available at the marketing stage other than retail stage Available at the importer stage = marketing stage for imports Information for enforcement authorities Supporting information has to be available at all stages for all declaration of compliance 60

61 Supply chain for food packaging 61

62 Supply chain regulation support 62

63 Issuers and recipients along the chain Flow of goods for food contact materials, their intermediate products and raw materials Declaration of compliance (DoC) Flow of goods of packed food Information/confirmation on suitability/information on composition/status of other intermediate products not subject to the scope of Regulation (EU) No. 10/

64 Sample of DoC document Minimum requirements for a declaration of compliance/standard declaration/sample 64

65 DoC documents 65

66 Supporting documents 66

67 Declaration of compliance (Conclusion) Purpose of the declaration of compliance: - Corresponds to the principle of responsibility of each stage - Supports the flow of information along the chain - Helps to identify material - Basis for specific assessment of suitability - Basis for concluding assessment of compliance Target groups: - Customers, i.e. users and processors - Surveillance authorities (upon request) 67

68 Declaration of compliance (Conclusion) Contents: - Confirmation of compliance with regulations relating to food - Information on suitability with important specifications on possible use - General information on compliance testing performed Point in time when information is needed: - When the material shall be used, e.g. in the packaging process 68

69 Declaration of compliance (Conclusion) The tasks and obligations to provide information concern various stages, i.e. the manufacture and processing of plastic materials in different companies, e.g.: Producer/ supplier of raw materials Producer of starting products Manufacture of (final) products/ processor/ converter User of the product/ packer of food products 69

70 Declaration of compliance (Conclusion) The food business operators are required to verify that foods are compliant with the rules applicable to them. 70

71 Example declaration of compliance within the supply chain Metal lid with sealing compound 71

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73 DSS & Fraunhofer IVV Exchange researcher EU project (FACET) Determination of partition coefficients for migrants between layers used in multilayer food packaging materials Chinawat Tongchat 73 73

74 DSS & Fraunhofer IVV Chinawat Tongchat 74 74

75 What is FACET project? Chinawat Tongchat 75 75

76 What is FACET project? Chinawat Tongchat 76 76

77 What is FACET project? Chinawat Tongchat 77 77

78 Migration modelling Migration (M) from a polymer into food is mainly a function of: Initial migrant concentration in the polymer, C P,0 Transfer of migrant from polymer surface into and its mobility in the food, both could be summarized as effective diffusion coefficient, D P Partition coefficient between polymer and food, K P,L Chinawat Tongchat 78 78

79 Partition coefficient (K) Chinawat Tongchat 79 79

80 Multi-layer packaging Chinawat Tongchat 80 80

81 Migration modelling in multi-layer material Chinawat Tongchat 81 81

82 Determination of partition coefficient in multi-layer material Materials (PA, PET, LDPE, paper & board) 16 Surrogate substances 4 storage temperatures (20 C, 40 C, 60 C and 80 C) Maximum storage time, 1 year at 20 C Chinawat Tongchat 82 82

83 Determination of partition coefficient in multi-layer material Benzophenone DPB Uvitex OB 40 C 60 C Chinawat Tongchat 83 83

84 Thank you for your attention!