PowerPoint 演示文稿

Size: px

Start display at page:

Download "PowerPoint 演示文稿"

不绣张
5 years ago
Views:

1 Updates on FCM Standards Developments in China Lei Zhu China National Center for Food Safety Risk Assessment

2 1.Overview of FCM Management 2.New FCM Standards Framework Topics 3. Some FCM Standards 4.FCM Compliance

3 Overview of FCM Management

1. Definition of FCM in China 4 Food Related Products Food packaging materials and containers Detergent Disinfectant Utensils and equipment used in food Food Contact Materials Under normal use

4 1. Definition of FCM in China 4 Food Related Products Food packaging materials and containers Detergent Disinfectant Utensils and equipment used in food Food Contact Materials Under normal use conditions, materials and articles which are already in contact with and are intended to contact with food or food additives, or can transfer their constituents into food. Including food packaging materials, containers, utensils and equipment in manufacturing, processing, packing, transporting, selling and using of food, and inks, adhesives and lubricants which are probably directly or indirectly contact with food. Not including detergent, disinfectant and public water supply equipment.

5 1. Management of FCM in China 5 Risk management NHFPC CFSA Risk assessment NHFPC CFSA Compliance AQSIQ

6 1. Framework of Law, Regulations and standards on FCM 6 Regulations, National Safety Standards & GOV Notifications Other Standards Food Safety Law

7 New FCM Standards Framework

8 2. FCM Standards Framework 8 GB General safety principles for FCM GB General manufacturing practice for FCM Horizontal standard GB 9685 be used in plastic be used in rubber be used in coating be used in adhesive Material standard Plastic resin Plastic materials and articles Rubber Coating Adhesive Metal and alloy Paper and board Test method General principle of the migration test for FCM General principle of pretreatment of the migration test for FCM Migration test of individual index in GB 9685 and material standards

9 1. List of FCM Standard Published-64 In draft-8 1 General safety principles for FCM 2 Horizontal standard Standards for the uses of additives in FCM 3 Plastic materials and articles 4 Plastic resin 5 Rubber 6 Rubber nipple 7 Coating 8 Paper and paperboard 9 Glass 10 Metal and alloy 11 Ceramics 12 Commodity standard Disinfection of tableware 13 Enamel 14 Disinfectant 15 Adhesive 16 Bamboo and wood 17 Mutilayer material 18 Printing ink 19 Detergent 20 Cellphone 21 Starch-based plastic 22 Manufacturing practice General manufacturing practice for FCM 23 General principle of the migration test for FCM 24 Test method General principle of pretreatment of the migration test for FCM 9

10 Some FCM Standards

11 3. GB General safety principles for FCM 11 GB General safety principles for FCM GB General manufacturing practice for FCM Horizontal standard GB 9685 be used in plastic be used in rubber be used in coating be used in adhesive Material standard Plastic resin Plastic materials and articles Rubber Coating Adhesive Metal and alloy Paper and board Test method General principle of the migration test for FCM General principle of pretreatment of the migration test for FCM Migration test of individual index in GB 9685 and material standards

12 GB General safety principles for FCM FC w S w A w ll.fo R od igh co ts nt R ac es ts er ci ve en d ce.o rg Food contact materials and articles NIAS Coordination Multi-materials FCM 0.01mg/kg Threshold DOC and labelling

13 3. GB Standards for Uses of Additives in FCM 13 GB General safety principles for FCM GB General manufacturing practice for FCM Horizontal standard GB 9685 be used in plastic be used in rubber be used in coating be used in adhesive Material standard Plastic resin Plastic materials and articles Rubber Coating Adhesive Metal and alloy Paper and board Test method General principle of the migration test for FCM General principle of pretreatment of the migration test for FCM Migration test of individual index in GB 9685 and material standards

14 3. GB Standards for Uses of Additives in FCM 14 FCA No. FCA 0696 Appendix A Chinese name CAS No. Copper ; iodide Maximum use level(%) PA,PBT,POM: use as manufacturing need Total Specific Migration Limit SML/QM (mg/kg) SML (T) (mg/kg) Appendix B SML(T) Restriction number 1 6 Other requirements SML of copper comply with Appendix C Appendix E The cross reference Appendix D Abbreviation for Resins Particular Restrictions for Metal Ions Appendix C

15 3. GB Standards for Uses of Additives in FCM 15 Appendix B Total Specific Migration Limit(SML(T)) SML(T) group restriction No CAS No. Substance name 乙醛丙酸乙烯酯硬脂酸与乙二醇的酯乙二醇二甘醇顺丁烯二酸酐 ( 又名马来酸酐 ) 马来酸 ( 又名顺丁烯二酸 ) 己内酰胺己内酰胺钠盐 ,2 - 亚甲基二 [4- 甲基 -6-(1- 甲基环己基 )] 苯酚 ,2'- 甲亚基双 (4- 甲基 -6- 环己基苯酚 ) SML (T) (mg/kg) group restriction Specification 6 以乙醛计 30 以乙二醇计 30 以马来酸计 15 以己内酰胺计 3 以物质之和计

16 3. GB Standards for Uses of Additives in FCM 16 Appendix C Particular Restrictions for Metal Ions Metal Ions SML(mg/kg) Barium 1 Cobalt 0.05 Copper 5 Iron 48 Lithium 0.6 Manganese 0.6 Zinc 25

17 3. GB Standards for Uses of Additives in FCM 17 Appendix D Abbreviation for Resins in table A.1 No. Abbreviation English name Chinese name 1 AS Acrylonitrile Styrene 丙烯腈 - 苯乙烯 2 ABS Acrylonitrile Butadiene Styrene 丙烯腈 - 丁二烯 - 苯乙烯 3 BDR Polybutadiene 聚丁二烯 4 E/NB 5 EVA Ethylene-2-norbornene 乙烯与二环 [2,2,1] 庚 -2- 烯共 copolymer 聚物 ethylene-vinyl acetate resin 乙烯 - 乙酸乙烯酯共聚物 6...

18 3. GB Standards for Uses of Additives in FCM 18 Appendix E The cross reference(by CAS No. and Chinese name)

19 3. GB Standards for Uses of Additives in FCM 19 Number of listed substances: More substances: 958 to 1294 Add: 364 new substances and 198 substances enlarge use applications and use levels which listed in NHFPC Notification Delete: high risk substances(4 phthalates, NVP, 3 perfluorinated compounds), 2 hydrates, 19 food additives... Revise: restriction on FCM of specified infant and baby use, DL of SML with ND, SML to SML(T)

20 3. GB Standards for Uses of Additives in FCM 20 Enlarge additives approved for using in food contact materials: Substances listed in Appendix A; Mixture of listed substances; Food additives of no use limit and no application range listed in table A.2 in GB 2760; Sodium, potassium and calcium salts of acids, alcohols and phenols listed; Crystalline hydrate formed by substances listed; Polymer authorized with a molecular weight above 1000 Da.

21 3. GB Plastic materials and articles 21 GB General safety principles for FCM GB General manufacturing practice for FCM Horizontal standard GB 9685 be used in plastic be used in rubber be used in coating be used in adhesive Material standard Plastic resin Plastic materials and articles Rubber Coating Adhesive Metal and alloy Paper and board Test method General principle of the migration test for FCM General principle of pretreatment of the migration test for FCM Migration test of individual index in GB 9685 and material standards

22 GB Plastic materials and articles 22 Combine: Standard No. GB GB GB GB GB GB GB GB GB GB GB Standard Title 食品包装用聚氯乙烯成型品卫生标准食品包装用聚乙烯成型品卫生标准食品包装用聚丙烯成型品卫生标准食品包装用聚苯乙烯成型品卫生标准食品容器包装材料用三聚氰胺 - 甲醛成型品卫生标准食品容器及包装材料用聚对苯二甲酸乙二醇酯成型品卫生标准食品容器包装材料用聚碳酸酯成型品卫生标准食品包装用聚氯乙烯瓶盖垫片及粒料卫生标准食品包装材料用尼龙成型品卫生标准食品容器包装材料用橡胶改性的丙烯腈 - 丁二烯 - 苯乙烯成型品卫生标准食品容器包装材料用丙烯腈 - 苯乙烯成型品卫生标准

23 GB Plastic materials and articles Scope Plastic materials and articles and Unvulcanized thermoplastic elastomer materials and articles 2. Terms and Definitions 3. Basic requirements 4. Technical requirements 4.1 Raw materials GB Annex A resin list 4.2 Senses 4.3 Physical and chemical: OML, consumption of potassium permanganate, heavy metals, etc 4.4 Additives 5. Others 5.1 Migration test General requirements(gb and GB ) 5.2 Labeling Resin names

24 3. GB General principles of migration test for FCM 24 GB General safety principles for FCM GB General manufacturing practice for FCM Horizontal standard GB 9685 be used in plastic be used in rubber be used in coating be used in adhesive Material standard Plastic resin Plastic materials and articles Rubber Coating Adhesive Metal and alloy Paper and board Test method General principle of the migration test for FCM General principle of pretreatment of the migration test for FCM Migration test of individual index in GB 9685 and material standards

25 3. GB General principles of migration test for FCM 25 Horizontal test method Cover all FCM, EXCEPT special provisions in material standards General principles Food simulants; Time & temperature; Temperature accelerated test; Conditions of Total migration test; Screening test & substitution test; Calibration

26 3. GB General manufacturing practice for FCM 26 GB General safety principles for FCM GB General manufacturing practice for FCM Horizontal standard GB 9685 be used in plastic be used in rubber be used in coating be used in adhesive Material standard Plastic resin Plastic materials and articles Rubber Coating Adhesive Metal and alloy Paper and board Test method General principle of the migration test for FCM General principle of pretreatment of the migration test for FCM Migration test of individual index in GB 9685 and material standards

27 3. GB General manufacturing practice for FCM 27 Horizontal standard Cover all FCM Raw materials, manufacture, transport, reserve Sanitary requirements and management guidelines for the production places, facilities and staffs

28 3. Establishing or revising FCM standards Adhesive Printing ink Multi-layer Bamboo and wood Starch-base plastic 28

29 3. Establishing or revising FCM standards 29 Adhesive PL: monomer or polymer? Reactive adhesive? Technical necessity survey of substances in pressuresensitive adhesive Migration test of pressure-sensitive adhesive

30 3. Establishing or revising FCM standards 30 Printing ink Industry survey on direct-contacting ink PL or not? Migration test condition of FCM with printing ink Test and risk assessment of mineral oil, photoinitiator (ITX Benzophenone), solvent, heavy metals, PAA etc. Barrier property of base materials Operation methods of preventing and controlling risk

31 FCM compliance

32 4. FCM compliance-plastic materials and articles 32 General Material Additive Migration test Manufacturing GB GB Standards GB GB9685 GB31603 GB GB Requirem ents 1.General principles 2.NIAS mg/k g exemption 4.Labelling 5.DOC.. 1.OML, consumption of potassium permanganate, heavy metals, etc. 2.Resin which is listed in GB Annex A or Notifications 3. Limits of monomers and other starting substances 4. Note of GB Annex A(ignition residue, etc.) 5.Special requirement for some resins 6.Special labelling 1.Additives listed in GB9685 table A.1 or Notifications, or A.13, or 0.01mg/kg exemption 2.Scope, limit, other requirements 1. Food simulants; Time & temperature; pretreatment 2. Migration test of individual index Sanitary requirements and management guidelines for the production places, facilities and staffs

33 4. Conclusions 33 Wholeness Transparency Scientificity Sharing Process

34 4. Challenges and suggestions 34 Due to limited time of clean-up and integration, some standards should be studied and revised step by step; The operability and validity of some standards will be tested in practice; The deficiency problem especially the test methods standard should be solved; Implementation guidance documents should be promoted and published ASAP; Industries confront several challenges, effective implementation is the greatest one; Supervision should be based on science.

35 Thank you!

Print

Print HONG KONG PHARMACEUTICAL JOURNAL VOL 16 NO 1 (Supplement 1) Jan March 2009 ISSN 1727-2874 A Consolidated List of Poisons, Antibiotics and Dangerous Drugs Last update: February 2009 The Pharmaceutical Society