all developments in china fcs -...

Updates on FCM Standards Developments in China

Lei ZhuChina National Center for Food Safety Risk Assessment

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Topics

1.Overview of FCM Management

2.New FCM Standards Framework

3. Some FCM Standards

4.FCM ComplianceFCS All Righ

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Overview of FCM Management FCS All R

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41. Definition of FCM in China

Food Contact MaterialsUnder normal use conditions, materials andarticles which are already in contact with andare intended to contact with food or foodadditives, or can transfer their constituentsinto food. Including food packaging materials,containers, utensils and equipment inmanufacturing, processing, packing,transporting, selling and using of food, andinks, adhesives and lubricants which areprobably directly or indirectly contact withfood. Not including detergent, disinfectantand public water supply equipment.

Food Related Products·Food packaging materials and

containers· Detergent· Disinfectant· Utensils and equipment used in food

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51. Management of FCM in China

Risk management

• NHFPC

• CFSA

Riskassessment

• NHFPC

• CFSA

Compliance

• AQSIQ

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61. Framework of Law, Regulations and standards on FCM

Other Standards

Food Safety Law

Regulations，National Safety Standards & GOV Notifications

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New FCM Standards FrameworkFCS All R

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82. FCM Standards Framework

•List of additives can be used in plastic

•List of additives can be used in rubber

•List of additives can be used in coating

•List of additives can be used in adhesive

GB 9685 Plastic resin

Rubber

Coating

Adhesive

Plastic materials and articlesGB 4806.1

General safety principles for FCM

General principle of the migration test for

FCM

General principle of pretreatment of the migration test for

FCM

Test method

Migration test of individual index in

GB 9685 and material standards

Material standardHorizontal standard

………… ………… …………

Paper and board

Metal and alloy

GB 31603General

manufacturing practice for FCM

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91. List of FCM Standard

• Published-64• In draft-8

1 Horizontal standard

General safety principles for FCM2 Standards for the uses of additives in FCM3

Commodity standard

Plastic materials and articles4 Plastic resin5 Rubber6 Rubber nipple7 Coating8 Paper and paperboard9 Glass10 Metal and alloy11 Ceramics12 Disinfection of tableware13 Enamel14 Disinfectant15 Adhesive16 Bamboo and wood17 Mutilayer material18 Printing ink19 Detergent20 Cellphone21 Starch-based plastic22 Manufacturing practice General manufacturing practice for FCM23

Test methodGeneral principle of the migration test for FCM

24 General principle of pretreatment of the migration test for FCM

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Some FCM StandardsFCS All R

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11






Rubber

Coating

Adhesive




FCM


FCM

Test method




………… ………… …………

Paper and board

Metal and alloy

GB 31603General


3. GB 4806.1 General safety principles for FCM

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123. GB 4806.1 General safety principles for FCM

Food contact materials and articles NIAS Coordination

Multi-materials FCM 0.01mg/kg Threshold DOC and labelling

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13






Rubber

Coating

Adhesive




FCM


FCM

Test method




………… ………… …………

Paper and board

Metal and alloy

GB 31603General


3. GB 9685-2016 Standards for Uses of Additives in FCM

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14

FCA

No.

Chinese

name

CAS

No.

Maximum use

level（%）

SML/QM

(mg/kg)

SML (T)

(mg/kg)

SML(T)

Restriction

number

Other

requirements

FCA

0696Copper

iodide

7681-65-4；

1335-23-5

PA，PBT，POM：

use as

manufacturing need

1 6

SML of copper

comply with

Appendix C

3.

Appendix D

Appendix B

Appendix C

Appendix ATotal Specific Migration Limit

Particular Restrictions for Metal IonsAbbreviation for Resins

Appendix E

The cross reference

GB 9685-2016 Standards for Uses of Additives in FCM

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153.

Appendix B Total Specific Migration Limit（SML(T)）

SML(T)group

restriction No.CAS No. Substance name SML (T)

(mg/kg)group restriction

Specification

1 75-07-0 乙醛 6 以乙醛计105-38-4 丙酸乙烯酯

2硬脂酸与乙二醇的酯

30 以乙二醇计107-21-1 乙二醇111-46-6 二甘醇

3 108-31-6 顺丁烯二酸酐 (又名马来酸酐) 30 以马来酸计110-16-7 马来酸 (又名顺丁烯二酸)

4 105-60-2 己内酰胺 15 以己内酰胺计2123-24-2 己内酰胺钠盐

577-62-3 2,2’-亚甲基二[4-甲基-6-(1-甲基环己基)]苯酚

3 以物质之和计4066-02-8 2,2'-甲亚基双(4-甲基-6-环己基苯酚)


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163.

Metal Ions SML（mg/kg）Barium 1Cobalt 0.05Copper 5

Iron 48Lithium 0.6

Manganese 0.6Zinc 25

Appendix C Particular Restrictions for Metal Ions


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173.

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 ABSAcrylonitrile Butadiene

Styrene丙烯腈-丁二烯-苯乙烯

3 BDR Polybutadiene 聚丁二烯

4 E/NBEthylene-2-norbornene

copolymer

乙烯与二环［2,2,1］庚-2-烯共

聚物

5 EVAethylene-vinyl acetate

resin乙烯-乙酸乙烯酯共聚物

6 …. …… …..


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183.

Appendix E The cross reference(by CAS No. and Chinese name)


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193.

• 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)…


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203.

• 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.


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213. GB 4806.7-2016 Plastic materials and articles






Rubber

Coating

Adhesive




FCM


FCM

Test method




………… ………… …………

Paper and board

Metal and alloy

GB 31603General


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22

Combine:Standard No. Standard Title

GB 9681-1988 食品包装用聚氯乙烯成型品卫生标准GB 9687-1988 食品包装用聚乙烯成型品卫生标准GB 9688-1988 食品包装用聚丙烯成型品卫生标准GB 9689-1988 食品包装用聚苯乙烯成型品卫生标准GB 9690-2009 食品容器、包装材料用三聚氰胺－甲醛成型品卫生标准GB 13113-1991 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GB 14942-1994 食品容器、包装材料用聚碳酸酯成型品卫生标准GB 14944-1994 食品包装用聚氯乙烯瓶盖垫片及粒料卫生标准GB 16332-1996 食品包装材料用尼龙成型品卫生标准GB 17326-1988 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GB 17327-1988 食品容器、包装材料用丙烯腈-苯乙烯成型品卫生标准

GB 4806.7-2016 Plastic materials and articles

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23GB 4806.7-2016 Plastic materials and articles

1. ScopePlastic materials and articles and Unvulcanized thermoplastic elastomer materials and articles2. Terms and Definitions3. Basic requirements4. Technical requirements4.1 Raw materialsGB 4806.6 Annex A resin list4.2 Senses

4.3 Physical and chemical:OML, consumption of potassiumpermanganate, heavy metals, etc4.4 Additives5. Others5.1 Migration testGeneral requirements（GB31604.1and GB5009.156）5.2 LabelingResin names

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243. GB 31604.1-2015 General principles of migration test for FCM






Rubber

Coating

Adhesive




FCM


FCM

Test method




………… ………… …………

Paper and board

Metal and alloy

GB 31603General


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253. GB 31604.1-2015 General principles of migration test for FCM

• 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;

CalibrationFCS All R

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263. GB 31603-2015 General manufacturing practice for FCM






Rubber

Coating

Adhesive




FCM


FCM

Test method




………… ………… …………

Paper and board

Metal and alloy

GB 31603General


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273. GB 31603-2015 General manufacturing practice for FCM

• Horizontal standard

• Cover all FCM

• Raw materials , manufacture, transport, reserve…

• Sanitary requirements and management guidelines

for the production places, facilities and staffs…FCS All Righ

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283.

AdhesivePrinting inkMulti-layerBamboo and woodStarch-base plastic

Establishing or revising FCM standards

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293.

PL: monomer or polymer? Reactive adhesive? Technical necessity survey of substances in pressure-

sensitive adhesive Migration test of pressure-sensitive adhesive


Adhesive

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303.

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, PAAetc.

Barrier property of base materials Operation methods of preventing and controlling risk


Printing ink

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FCM complianceFCS All R

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324. FCM compliance-plastic materials and articles

General Material Additive Migration test Manufacturing

Standards GB4806.1 GB4806.7GB4806.6 GB9685 GB31604.1、

GB5009.156…. GB31603

Requirements

1.Generalprinciples2.NIAS3.0.01mg/kg exemption4.Labelling5.DOC…..

1.OML, consumption of potassium permanganate, heavy metals, etc.2.Resin which is listed in GB4806.6 Annex A or Notifications 3. Limits of monomers and other starting substances4. Note of GB 4806.6 Annex A（ignition residue, etc.）5.Special requirement for some resins6.Special labelling

1.Additives listed in GB9685 table A.1or Notifications, or A.13,or 0.01mg/kg exemption2.Scope, limit, other requirements

1. Food simulants; Time & temperature; pretreatment2. Migration test of individual index

Sanitary requirements and management guidelines for the production places, facilities and staffs

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334. Conclusions

Process

SharingTransparency

ScientificityWholeness

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344. Challenges and suggestions

• 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.FCS All R

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Thank you！FCS All R

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