2017-12-05 - Intertek Webinar - China Food Contact Regulations

China Food Contact Regulations
Carrie Wang
HERS, Intertek
Dec 2017
Agenda
01 Introduction 04 Product Standards
02 Overview of New GB Framework 05 Test Methods
03 Basic Standards 06 In the future?
Copyright © 2017 Intertek. 2
Part 1
Introduction
Our Global Network and Capabilities
Global More than
Market
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4
© Intertek Group with over 42,000 Employees
Health, Environmental & Regulatory Services (HERS)
Chemicals & Pharmaceuticals Food & Environmental, Cosmetics &

Restricted Food Contact
Biocides & Healthcare Nutrition Safety & Personal Care
Substances
Sustainability
Copyright © 2017 Intertek.
Health, Environmental & Regulatory Services (HERS)
• A Global Network of Regulatory, Scientific and Engineering assurance experts:
• Over 230 staff located world wide: EMEA (80 staff), Americas (120 staff), APAC (32 staff)
• 24 offices in 12 countries
• +20 PhDs, 70+ Masters, licensed professionals and a wide range of industry‐experienced Experts
• HERS has experts in multiple scientific and engineering disciplines, specializing in:
• Regulatory
• Product Safety
• Toxicology
• Sustainability
• Environmental Health & Safety
Global Food Contact Service
•Food contact notification •Test
• USA/EU/China/Japan • Tests according to US FDA/EU/China/Japan/
Germany LFGB/France DCG/… rules
• Analytical method development
•Declaration of compliance / Formulation review
• Mathematical modeling for SML components
•Risk assessment and management
•Consulting
•NIAS studies
• Strategic consulting worldwide
• Training 7
Part 2
Overview of New GB
Framework
2. New GB Framework of FCM
On Nov. 18th 2016, 51 new GB standards
published
Brand new GB framework established
 GB xxxx‐xxxx
 MANDATORY

Food Contact Material & Article
GB Standards
Basic Standards Product Standards Test Method

GB 4806.3‐2016
GB 4806.1‐2016 Enamels GB 31604.1‐2015
GB 31603‐2015
GB 9685‐2016
General Safety GB 4806.4‐2016 General rules for migration
GMP Additives
Requirements Ceramics test
GB 4806.5‐2016
Plastic Glass GB 5009.156‐2016
GB 4806.6‐2016 General rules of
Coating Plastic Resin pretreatment for the
GB 4806.7‐2016 migration Test
Rubber
Plastic Material and Articles
GB 4806.8‐2016 GB 31604.2‐2016 ~
Ink
Paper GB 31604.49‐2016
GB 4806.9‐2016
Adhesive
Metal
GB 4806.10‐2016
Paper …
Coating
GB 4806.11‐2016
Others
Copyright © 2017 Intertek. Rubber 10
…
Effective Date
GB 31604.1‐2015 General rules for migration test GB 4806.3‐2016 ~ GB 4806.11‐2016 Product Standards
GB 31603‐2015 GMP GB 31604.11‐2016 ~ GB 31604.49 Test methods
Sep. 21st, 2016 Mar. 1st, 2017 Apr. 19th, 2017 Oct. 19th, 2017
GB 31604.2‐2016 ~ GB 31604.10‐2016 GB 4806.1‐2016 General safety requirements
Test methods GB 9685‐2016 Additives
Part 3
Basic Standards
New GB Framework of FCM
GB Standards

GB 4806.3‐2016
GB 4806.1‐2016 Enamels GB 31604.1‐2015
GB 31603‐2015
GB 9685‐2016
GMP Additives
GB 4806.5‐2016
Rubber
GB 4806.8‐2016 GB 31604.2‐2016 ~
Ink
Paper GB 31604.49‐2016
GB 4806.9‐2016
Adhesive
Metal
GB 4806.10‐2016
Paper …
Coating
GB 4806.11‐2016
Others
…
3. Basic Standards
GB 4806.1‐2016 General Safety Requirements
•Newly established standard
•Applicable to all kinds of FCM/A
3. Basic Standards
Definitions
•Under the normal condition of uses
•Already or expected to be in contact with Food and Food Additives (hereinafter referred to as food)
•its components may transfer into food
•Manufacture, process, packaging, transportation, storage, retail and use of food
•Printing inks, adhesive and lubricants etc.
•Detergents, disinfectants and facility for public plumbing of water NOT included.
3. Basic Standards
Definitions
• Overall Migration
• Specific Migration
• Total specific migration
• Residual Quantity
• OML, SML, SML(T), QM
• Composite material and articles
• Combined material and articles
• NIAS (Non Intentionally Added Substances)
• Functional barrier
3. Basic Standards
Basic Requirements
• NOT endanger human health
• NOT bring about an unacceptable change in the composition of the food nor bring about a
deterioration in the organoleptic characteristics thereof
• Lower the use amount as much as possible
3. Basic Standards
GB 9685‐2016
GB 4806.X‐2016
Dosage
&
migratio
n limit
Rules of
GB 4806.1‐2016 Labeling complia
GB 9685‐2016
GB 4806.X‐2016 Basic nce GB 4806.X‐2016
require
ments
Traceabi Test GB 31604.1‐2015

GB 31603‐2015 lity method GB 5009.156‐2016
GB 31604.x‐2016
3. Basic Standards
Declaration of Compliance (DoC)
• Required in the whole supply chain
• Tiered approach for different roles in the whole Food
supply chain manufacturer
Final article s (Users of
• Select relevant parts to declare
manufacturers final articles)
• GB standard No. & Name
• Use restriction (intended use conditions) Intermediate Complex
• Overall migration/KMnO4 consumption/… material
manufacturers
• Specific migration
Chemical
substances
manufacturers
Simple
3. Basic Standards
Labeling
• FINAL ARTICLE
• mark with ‘食品接触用 (for food contact)’
• Exemptions: articles with clear for food‐contact
uses such as chopsticks and frying pans
• Use restrictions
• Requirements in GB 4806.X (product standards)
GB Standards

GB 4806.3‐2016
GB 4806.1‐2016 Enamels GB 31604.1‐2015
GB 31603‐2015
GB 9685‐2016
GMP Additives
GB 4806.5‐2016
Rubber
GB 4806.8‐2016 GB 31604.2‐2016 ~
Ink
Paper GB 31604.49‐2016
GB 4806.9‐2016
Adhesive
Metal
GB 4806.10‐2016
Paper …
Coating
GB 4806.11‐2016
Others
…
3. Basic Standards
GB 9685‐2016 Additives
GB 9685‐2016 Standard for Uses of Additives in Food Contact Materials and Articles
•Revise and Replace GB 9685‐2008
•From 958 to 1294
•Delete 35 substances
•……
3. Basic Standards
GB 9685‐2016 Standard for Uses of Additives in Food Contact Materials and Articles
Additives Everything in your formula
•Improve or to aid in improving the qualities and properties of the materials
•Added during the manufacturing process to guarantee smooth production
3. Basic Standards
POSITIVE List  Appendix A (Positive List)
Additives permitted for use in food contact
Appendix A materials and articles and use requirements
Max
SML/  Appendix B
Table A.1 Additives permitted for use in plastic
QM SML(T) SML(T) Other
FCA Chinese CAS Use
No. Name No. Level
/ (mg/kg Group Requirem Table B.1 Total Specific Migration Limit
materials and articles
(mg/k ) No. ents
(%)
g) Table A.2 Coatings
 Appendix C
1,3-二异 Table A.3 Rubber
氰酸基甲 1.0 Specific Restrictions on Metal Elements
苯
PU:
(QM, ND Table A.4 Printing inks
FC 2647 Dosag
A00
benzene,
1-62- e as
expre (DL=0.
17
Table A.5 Adhesives
Appendix D
1,3- ssed 01m
68 5 neces
diisocyan
sary
as g/kg); Table A.6 Paper
Meaning of short forms of plastic materials
atomethy NCO)
l- Table A.7 Silicone rubber and others
Appendix E
Appendix D Appendix B Appendix C Index contents of additives used in food
contact materials and articles
3. Basic Standards
What if the additive is not in the positive list?
•Exemption Clause (Appendix A.13) • Functional Barrier
1) Mixture • NIAS
2) GB 2760 (Food Additive Standard) Table A.2
3) ‘Acid, alcohols or phenols’ VS ‘their salts’ • Official Notice published by NHFPC
(sodium salt, potassium salt and calcium salt ) • 75 substances in 7 Notices
4) Crystalline water substance (5 Notices issued from 2012 to 2014 were integrated into the GB
9685‐2016)
5) Polymer (m.w.>1000)
Otherwise, Petition will be
needed!
Petition
1) Notice of Ministry of Health on 1. Application form
2. Physico‐chemical properties
“Administrative Approval on Food‐related
3. Technical necessity, usage and conditions for use
products” (MOH (2011) No.25 )
4. Production process
• Administrative procedures & requirements 5. Quality specifications
6. Toxicological information
2) Notice of Ministry of Health on “Chinese New
7. Migration test and/or residue, dietary exposure level and
Food‐related Product petition” (MOH (2011) evaluation methods
No.49 ) 8. Information or certificates of permission use at home and abroad
• Data requirements 9. Other information beneficial to assessment
10. Application range & application amount
Part 4
Product Standards
GB Standards

GB 4806.3‐2016
GB 4806.1‐2016 Enamels GB 31604.1‐2015
GB 31603‐2015
GB 9685‐2016
GMP Additives
GB 4806.5‐2016
Rubber
GB 4806.8‐2016 GB 31604.2‐2016 ~
Ink
Paper GB 31604.49‐2016
GB 4806.9‐2016
Adhesive
Metal
GB 4806.10‐2016
Paper …
Coating
GB 4806.11‐2016
Others
…
4. GB 4806.x‐2016 Product Standards
1. Scope
2. Definition
3. Basic Requirements
4. Technical Requirements
a) Requirements for Raw Materials
Requirements for Raw Materials
b) Sensory Requirements
c) Physical and Chemical Indicators
Physical and Chemical Indicators
d) Additives
5. Other requirements/specifications
Migration Test
a) Migration Test
Label Identification
b) Label Identification

• GB 4806.3‐2016 Enamels • GB 4806.6 & GB 4806.7 Plastic • GB 4806.8‐2016 Paper

• GB 4806.4‐2016 Ceramics • GB 4806.10‐2016 Coating
• GB 4806.5‐2016 Glass • GB 4806.11‐2016 Rubber
• GB 4806.9‐2016 Metal

•GB 4806.6‐2016 Resins for Food Contact Plastic Materials and Articles

• Resin
• Resin blend
• Non‐vulcanized thermoplastic elastomer resin
•GB 4806.7‐2016 Food Contact Plastic Materials and Articles
•• GB 4806.6 & GB 4806.7
GB 4806.3‐2016 Enamels
• Plastic
GB 4806.4‐2016 Ceramics • Material: plastic granules (or chips), master batches and sheet
•• GB 4806.10‐2016
GB 4806.5‐2016 Glass materials
Coating • Article: Articles molded or processed into certain shapes from plastic resin
• GB 4806.9‐2016 Metal
• GB 4806.11‐2016 or material
Rubber


• Positive list of POLYMER (102 Resin)
SML(T)
Generic SML/QM (mg/kg) SML(T)
No. Chinese Name CAS. No. Group Note
Name (mg/kg)
No.
1,1,1,2,2,3,3-七氟-3-
[(三氟乙烯基)氧]丙烷与四氟乙
•• GB 4806.6 & GB 4806.7
GB 4806.3‐2016 Enamels 烯的聚合物 0.05 mg/kg
• Plastic
GB 4806.4‐2016 Ceramics 2
Propane, 1,1,1,2,2,3,3-
26655-00-5 PFA
(tetrafluoroethylene:
Heptafluoro -3- SML)
•• GB 4806.10‐2016
GB 4806.5‐2016 Glass [(Trifluoroethenyl)oxy]-,
polymer with
Coating Tetrafluoroethene
• GB 4806.9‐2016 Metal
• GB 4806.11‐2016 1,12-十二烷二酸与1,6-
2.4 mg/kg (1,6-
Rubber 己二胺的聚合物(聚十二烷二酰
hexamethylene
已二胺，聚酰胺612)
3 26098-55-5 PA diamine monomer:
1,12-Dodecanedioic Acid,
SML)
polymer with 1,6-
Hexanediamine ( PA612)


• Special limits for PC, PS, PP, PET and PE
Resin Limits Resin Limits

PC •W20% of Ethanol extract ≤ 15mg/L PET •water extract ≤ 0.5%
•4% of acetic acid extract ≤ 15mg/L •65% of ethanol extract ≤
•n‐hexane extract ≤ 15mg/L 0.5%
•• GB 4806.6 & GB 4806.7
GB 4806.3‐2016 Enamels •Potassium permanganate •4% of acetic acid extract ≤
• Plastic
GB 4806.4‐2016 Ceramics consumption ≤ 10mg/L 0.5%
•• GB 4806.10‐2016
GB 4806.5‐2016 Glass •Heavy metal (based on Pb) ≤ 1.0mg/L •n‐hexane extract ≤ 0.5%
Coating •ater extract ≤ 15mg/L •Lead ≤ 1mg/kg.
• GB 4806.9‐2016 Metal
• GB 4806.11‐2016 PS •Loss on drying ≤ 0.2% PE •Loss on drying ≤ 0.15%
Rubber •Volatile matter ≤ 1.0% •Ignition residue ≤ 0.20%
•n‐Hexane extract ≤ 1.5% •n‐Hexane extract ≤ 2.00%.
PP •n‐Hexane extract ≤ 2%.

•GB 4806.7‐2016 Food Contact Plastic Materials and Articles
• Physical and Chemical Indicators
• Overall migration:
• Varied condition based on actual contact t & T with food
• GB 31604.1‐2015
•• GB 4806.6 & GB 4806.7
Items Indicator
• Plastic
GB 4806.4‐2016 Ceramics
Overall migration /(mg/dm2)b ≤ 10
•• GB 4806.10‐2016
GB 4806.5‐2016 Glass
KMnO4 consumption/ (mg/kg) ≤ 10
Coating
• GB 4806.9‐2016 Metal Heavy metal (as Pb)/(mg/kg) ≤ 1
• GB 4806.11‐2016
Rubber Decolorizing test c (only for plastic with Negative
pigment & colorant)

•GB 4806.10‐2016 Food contact Coating and Coating Layers
• Positive list of POLYMER (105 Resin)
•GB 4806.11‐2016 Food Contact Rubber Materials and Articles
• Positive list of POLYMER
•• GB 4806.6 & GB 4806.7
• Table A.1 Synthetic Rubber (24 Resin) Petition will be needed for
• Plastic
GB 4806.4‐2016 Ceramics
non‐listed polymer!
•• GB 4806.10‐2016
GB 4806.5‐2016 Glass • Table A.2 Silicone Rubber (19 Resin)
Coating
• GB 4806.9‐2016 Metal
• GB 4806.11‐2016
Rubber • Special requirements for simulants, test time & temperature
• Fatty food: 50% ethanol as simulant
• T <= 40 oC, t <=24 hours
•GB 4806.8‐2016 Food contact Paper and Paperboard
•Physical and Chemical Indicators
• Pb, As
• Residue Indicators
• Formaldehyde ≤ 1.0 mg/dm2
• GB 4806.3‐2016 Enamels
• GB 4806.8‐2016 • Fluorescent matter Wave length ‐ Negative
• GB 4806.4‐2016 Ceramics
Paper
• GB 4806.5‐2016 Glass • Migration limit
• Overall migration, KMnO4 consumption, Heavy metal (as Pb)
• Direct in contact with liquid foods, or having free water or free fat on their surfaces
• Microorganism limit
• Coliform bacteria, Salmonella, Mycete
• For paper used without disinfection or washing

•GB 4806.8‐2016 Food contact Paper and Paperboard
•Special migration requirement
• Pretreatment for filter paper
• Screening Method for Specific Migration: Water extraction test
• GB 4806.3‐2016 Enamels
• GB 4806.8‐2016
• GB 4806.4‐2016 Ceramics
Paper
• GB 4806.5‐2016 Glass •Raw material
• Plant fiber – no positive list requirement
• Synthetic fiber – polymer list in GB 4806.6
•Additive – GB 9685‐2016

•Physical and Chemical Indicators
• Migration limit for heave metal (e.g.: Pb, Cd, As, Cr, Ni etc.)
•Special migration requirement
• 4% acetic acid for most conditions
• GB 4806.3‐2016 • Particular rules on time & temperature
Enamels
• GB 4806.4‐2016
Ceramics •Special labeling requirement
• GB 4806.5‐2016
Glass
• For metal, material type and material composition shall be marked
• E.g.: “Stainless Steel 06Cr19Ni10” or “Stainless Steel S30408” or “Aluminium
• GB 4806.9‐2016 Metal Alloy 3004”
•No requirement on Positive list
Part 5
Test Methods
GB Standards

GB 4806.3‐2016
GB 4806.1‐2016 Enamels GB 31604.1‐2015
GB 31603‐2015
GB 9685‐2016
GMP Additives
GB 4806.5‐2016
Rubber
GB 4806.8‐2016 GB 31604.2‐2016 ~
Ink
Paper GB 31604.49‐2016
GB 4806.9‐2016
Adhesive
Metal
GB 4806.10‐2016
Paper …
Coating
GB 4806.11‐2016
Others
…
5. Test Methods
GB No. Content
GB 31604.1‐2015 Rules for selection of food simulant, test time, temperature for
General rules for migration test migration test
GB 5009.156‐2016 Requirements on chemical agents, equipment and instrument,
General rules of pretreatment for sampling methods, calculation of surface area, filling method,
migration Test etc.
Test methods for Physical and Chemical Indicators in product
GB 31604.2‐2016 ~ GB 31604.9 – 2016 standards (e.g.: KMnO4 consumption, heavy metal, discoloration test
etc.)
GB 31604.10‐2016 ~ GB 31604.49 – 2016 Test/analytical methods for individual substance
5. Test Methods
GB 31604.1‐2015 General rules for migration test
•Resembles to EU (No.) 10/2011 with difference China GB 31504.1‐2015 General rules for migration test
Food simulant Food Category
• 4% acetic acid VS 3% acetic acid
10% (v/v) Ethanol or Waterborne foods, Non acidic foods (pH≥5)
water alcohol content ≤ 10%
• Vegetable oil: Corn oil & Olive oil only (v/v)
4% (v/v) Acetic Acid Acidic foods (pH <5)
20% (v/v) Ethanol Alcohol content ≤ 20% (v/v)
• No simulant for dry food
20% (v/v) < Alcohol content ≤
50% (v/v) Ethanol Alcoholic beverages,
50% (v/v)
• … alcohol content >
Actual ethanol 10%(v/v)
concentration or 95% Alcohol content > 50% (v/v)
(v/v) ethanol
Grease and surface
Vegetable oil /
greasy foods
5. Test Methods
GB 31604.1‐2015 General rules for migration test
• T & t for overall migration • T & t for specific migration

Contact time in Time to be selected
Intended Time to be selected
T & t _ GB worst for testing _ China GB
food contact T & t _EU for testing _ EU
31604.1‐2015 foreseeable use 31504.1‐2015
conditions t ≤ 5 min 5 min
5 min < t ≤ 0.5 0.5 hour
(OM1) Any 0.5 hour
hour
food contact at 10 d at 20 °C (heating
frozen and 10 d at 20 °C treatment without in Worst Temperature to be
refrigerated contanier) Temperature to be
foreseeable selected for testing _
conditions. selected for testing _
contact China GB 31504.1‐
EU
temperature 2015
2 hours at 100 °C 175 °C < T ≤ 200
200 °C (*) Adjusting the
(heating in containers °C temperature to the
before eating)
actual
temperature in
T > 200 °C 225 °C (*)
place of contact
with foods. (*)
More differences…
Part 6
In the future?
6. Development of GB Standards
Standards Published Standards in Draft
• Revision Plan in 2018 • Draft version issued
• GB 31604.1‐2015 • Bamboo & Wood
• GB 4806.6‐2016 Resin for plastic (Oct., 2016)
• GB 4806.7‐2016 Plastic materials and articles • Composite Materials & Articles Standard
• GB 4806.9‐2016 Metal (June 2017)
• Draft version not issued, in progress
• Adhesive
• Ink
• Cellophane
• Starch‐based plastic
Food contact webinar series schedule
EU Food Contact: Regulation EU 10/2011 for Risk Assessments of Food Contact Materials that
plastic food contact materials fully into force on
01 January 1st 2016 07 Migrate into Food
November 28
October 3
US and Emerging Markets Food Contact China Food Contact Regulations
02 Regulations
October 17 08 December 5
Different Packaging Market: Compliance EU Food Contact Compliance for Paper and Board
03 throughout the Supply Chain
October 24 09 January 9
The Best Approach to Obtain FDA NO Objection
Letter (NOL) for Recycle Plastics and the Recycle EU Food Contact Compliance for Coatings
04 Impact on Lifecycle Analysis 10 January 16
October 31
Dispensing Machines FDA Food Contact GMP for Food Contact
05 Compliance
November 7 11 January 23
Inks and Colorants: Global Food Contact The Impact of the EU NIAS Regulations on the US
Regulations and Migration Studies Designed to
06 Ensure Safe Use in Packaging 12
FDA Final Articles Indirect Food Additives
Compliance
November 14 January 30
46
Register for our webinar series today! http://bit.ly/FC‐series
Carrie Wang
+86 21 6076 1395
Carrie.w.wang@intertek.com
www.intertek.com/regulatory/food‐contact/
3. Introduction on Basic Standards
Functional Barrier
• Exemption Clause
• Unlisted substances maybe used provided that
(all conditions must be met simultaneously)
 Not in direct contact with food
 Functional barrier
 Migration < 10 ppb
 Not CMR & Nantomaterial
3. Introduction on Basic Standards
Non Intentionally Added Substance (NIAS)
• Definition
 Not intentionally added, including
• Impurities from raw materials
• Bread‐down products ,contaminants, residue reaction intermediate during the process of
manufacture, operation & use
• Requirements
• Comply with basic requirements in GB 4806.1‐2016
• Self control & Risk assessment
Appendix B in GB 9685‐2016
SML(T)
•GB 9685‐2016 •(EU) No. 10/2011
NOT positive list

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China Food Contact Regulations

Chemicals & Pharmaceuticals Food & Environmental, Cosmetics &

Copyright © 2017 Intertek. 9

Basic Standards Product Standards Test Method

Sep. 21st, 2016 Mar. 1st, 2017 Apr. 19th, 2017 Oct. 19th, 2017

Basic Standards Product Standards Test Method

Traceabi Test GB 31604.1‐2015

Basic Standards Product Standards Test Method

Basic Standards Product Standards Test Method

Copyright © 2017 Intertek. 29

• GB 4806.3‐2016 Enamels • GB 4806.6 & GB 4806.7 Plastic • GB 4806.8‐2016 Paper

Copyright © 2017 Intertek. 30

•GB 4806.6‐2016 Resins for Food Contact Plastic Materials and Articles

Copyright © 2017 Intertek. 31

•GB 4806.6‐2016 Resins for Food Contact Plastic Materials and Articles

Copyright © 2017 Intertek. 32

•GB 4806.6‐2016 Resins for Food Contact Plastic Materials and Articles

Resin Limits Resin Limits

Copyright © 2017 Intertek. 33

Copyright © 2017 Intertek. 34

Copyright © 2017 Intertek. 36

Copyright © 2017 Intertek. 37

Basic Standards Product Standards Test Method

GB 31604.10‐2016 ~ GB 31604.49 – 2016 Test/analytical methods for individual substance

• T & t for overall migration • T & t for specific migration

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