2020-09-16 - Intertek Webinar - Compliance Strategy of Japan New Food Contact Regulations and Positive Lists

COMPLIANCE STRATEGY OF JAPAN
NEW FOOD CONTACT REGULATIONS

AND POSITIVE LISTS
Crystal Liu, Intertek HERS
16Sep 2020
CONTENT
01 Japan New Food Contact System
02 Japan New Positive Lists
03 Compliance Strategy and Case Study
04 Association-JCII
05 Summary
© Intertek 2020. All Rights Reserved. 2

01
JAPAN NEW FOOD CONTACT
SYSTEM
JAPAN AUTHORITY
MHLW FSCJ
Ministry of Labor and Food Safety
Welfare Commission of Japan
Risk
Risk Management Risk Assessment
Communication

NEW POSITIVE LIST-TIMELINE
Until Now 5-year Grace Period
Draft
Revised Revised
5-year Grace
Food Regulation Period is over,
Interim Sanitation and PL are Enterprises
Report by Art and PL published shall
MHLW by MHLW by MHLW compliance
2015.06 2017.06 2018.06 2019.05 2020.04 2020.06.01 2025.05.31
Full Interim Two Revised

Report by Guidelines of Food
MHLW, Risk Sanitation
Assessment
PL will be by FSCJ:
Art and PL
effective New/ are
on Jun. Current effective
2020 substances
© Intertek 2020. All Rights Reserved.

Regulations and PL under Revision 5
JAPAN FOOD CONTACT REGULATION
Japan FCM Structure
Food Sanitation Art Food Safety Basic Law

Law No. 233 1947 Law No. 48 2003
Food Sanitation Art-Revision
Law No. 46 2018
Order of Enforcement of Standards for Milk and Guideline on GMP Guideline on Risk
the Food Sanitation Art Diary Products 生食発 0710 No. 14 Assessment
MHLW No. 23 1948 MHLW No. 52 1951 2017 May 2019
Specifications and
Guideline on Recycled
Standards for
Plastic
Foods, Food Additives
食安発 0427 No. 2 2012
MHLW No. 370 1959
Specifications and
Standards for Guideline on Recycled
Foods, Food Additives- Paper
© Intertek Revision
2020. All Rights Reserved. 食安発 0427 No. 7 2012 By MHLW By FSCJ 6
th
28 Apr. 2020
COMPARISON OF OLD AND NEW SYSTEM OF JAPAN FCM
New System (New Positive Lists)

Old System
 New Positive Lists, only substances authorized
 No Positive Lists, only test requirements
 Can NOT confirm the safety of formulation of VS in the positive lists shall be used in the
formation of FCM
FCM
 Manage by Polymer
7
MHLW NOTICE NO. 195 AND NO. 196-28 APR 2020
MHLW notice No. 196

• Two are effective on 1st June 2020
1) Food Sanitation Art-Revision -Law No. 46 2018
2) Specifications and Standards for Foods, Food
Additives-Revision, 28th Apr. 2020 https://www.mhlw.go.jp/content/11130500/000625486.pdf
• Grace Period is 5 years!
MHLW notice No. 195
• Item 3 in Article 18 of Food Sanitation Art
The limit being unlikely to harm human health

shall be 0.01mg/kg food.
https://www.mhlw.go.jp/content/11130500/000625501.pdf
8
1. FOOD SANITATION ART-REVISION, LAW NO. 46 2018
Chapter 3 and Chapter 9 are related to FCM!
9
❖ Main Revision
Chapter 3 Utensil, Container and Packaging
- Article 18 3rd paragraph added

✓ Substances used in food contact articles shall comply with the requirements of positive lists.
✓ Do NOT harm to human health.
Chapter 9 Production and Operation

5-Year Grace
- Article 52 1st paragraph added
Period for this
✓ GMP requirements for manufacturer of food contact articles.
Revision!
- Article 53 New
✓ Information transfer and sharing through the whole supply chain.
10
❖ 5-Year Grace Period
Any substances as food contact use not authorized in New Positive Lists, but with activity of being manufactured, sold,
used in Japan, or exported to Japan before 31 May 2020, shall be allowed to continue to be manufactured, sold, used in
Japan, or exported to Japan during 5-year grace period of law.
① Nothing with the Batch No., Production date, Manufacturing data, but depending on whether there is activity in Japan before 31
May 2020.
② If a formulation is not compliant but with activity, it can be used in grace period. However, only the same is ok, any similar
formulation is not allowed to be used, eg, with same components but in different use ratios.
③ The allowed raw materials or products shall be sold to any company in Japan, not limited to companies that have had
transactions before.
11
All the substances

intended to be
❖ 5-Year Grace Period Japan
food contact use!
positive list
Effective on 1
These substances June 2020
can be used in food These substance shall not
contact during 5- be used in food contact
year grace period. unless it is added into PL.
Enterprises can Substances Enterprises shall submit a
submit the opinion Substances with without activity full dossier with like
of them to MHLW activity in Japan in Japan migration level and tox
and add them in to before 31 May before 31 May profile to MHLW and wait
PL in a simplified 2020 2020 for approval in a complex
way. way, like US FCN.
Only technical guideline, no
administrative guideline.
12
2. SPECIFICATIONS AND STANDARDS FOR FOODS, FOOD ADDITIVES, MHLW
NO. 370 1959 Specifications and Standards for Foods, Food
Additives
MHLW No. 370 1959
Chapter I Chapter II Chapter III Chapter IV Chapter V

Food Food Additive Packaging Toy Detergent
A. General B. Test C. Test D. Material E. Special F. Product

provision Method Reagent Requirement Purpose Requirement
OML Glass
Ceramics and
KMnO4 enamel
Synthetic
Heavy metal
resin
单体迁移SML Rubber
… Metal can
13
2. REVISION OF MHLW NO. 370, 28 APRIL 2020
Revision of MHLW No. 370, 28 April 2020
• Item 8 of A replaces Item 7 and delete Item 7;
• New Item 8 of A for positive lists:
✓ Any substances used in food contact materials and articles shall

comply with Annex I positive lists, including 2 resin lists, 1
additive lists and 1 monomer list.
✓ Pigment is NOT in the scope of Annex I positive lists.
✓ No usage limit for Table 1 (1) plastic resin list, (2) coating resin
list and (3) minor monomer list of Annex I.
✓ There are use temperature limit and contact food types for
each resin, but not for each additive.
14
2. REVISION OF MHLW NO. 370, 28 APRIL 2020
✓ Basic resins shall be authorized in Table 1 (1) plastic resin list or
(2) coating resin list of Annex I.
✓ 98% rule: A exemption for non-authorized basic resins: Find a

polymer made of some monomers of basic resin is listed in resin
lists of Annex I and total weight of these monomers in basic resin
is more than 98%, while the weight of each remaining monomer
is lower than 2% and also listed in Table 1 (3) minor monomer
list of Annex I.
✓ Basic resin for coating shall be listed in Table 1 (2) coating resin
list of Annex I.
✓ Restrictions and max use content for each resin group are
required for each additives in Table 2 of Annex I.
• Delete Item 5 of F.
15
3. GUIDELINES FOR ASSESSMENT OF HUMAN HEALTH EFFECTS FROM FOOD
APPARATUS, CONTAINERS AND PACKAGES, MAY 2019
From Dec. 2018 to May. 2019, FSCJ had hold some workshops and
then published two Guidelines of Risk Assessment for New and
Current substances, respectively.
For New substance
• Guidelines for Assessment of Human Health Effects of Food

Apparatus, Containers and Packages (Official version by 29th May 2019)
For current substance
• Guideline on Assessment of current substance in Food Apparatus,

Containers and Packages (No official version)
16
02
JAPAN NEW POSITIVE LISTS
REVISION OF MHLW NO. 370, 28 APRIL 2020
On 28 April 2020, MHLW published new positives as Annex I of Revision of Specifications and Standards for Foods, Food
Additives, MHLW No. 370.
Plastic Resin Coating Resin Minor Monomer Additive
Annex I
List No. Table 1, Annex I Table 2, Annex I
Table 1 (1), Annex I Table 1 (2), Annex I Table 1 (3), Annex I Table 2, Annex I
Total 17 types of
Total 71 types of resins, cross-linking
Number 262 Monomers 1665 Additives
resins agents, polymeric
cross-linking agents
As per characterization of resin, divide into 7 Max use content for
Specialty /
groups each resin group
18
TABLE 1 (1) PLASTIC RESIN LIST, ANNEX I, 28 APRIL 2020

TABLE 1 (2) COATING RESIN LIST, ANNEX I, 28 APRIL 2020

TABLE 1 (3) MINOR MONOMER LIST, ANNEX I, 28 APRIL 2020

TABLE 2 ADDITIVE LIST, ANNEX I, 28 APRIL 2020

SCOPE OF POLISITVE LIST FOR SYNTHETIC RESINS
❖ Classification of Synthetic Resins ❖ Comparison

• US: Synthetic resin, paper, rubber
Thermoplastic resins Thermosetting resins
Thermosetting plastics • EU: Synthetic resin,
Thermoplastics
Plastic eg., melamine resin,
eg., PE, PS
phenol resin
• EU members: Paper, rubber, metal, glass, etc.
Thermoplastic • Japan: Synthetic resin
Rubber (thermosetting
elastomer
Elastomer elastomer)
eg., polystyrene
eg., butadiene rubber,
elastomer, styrene-block
nitrile rubber
copolymer
Without a cross- With a cross-linking
Note
linking structure structure
*Blue in the scope
*Grey is not in the scope
23
SCOPE OF
POLISITVE
LIST FOR
SYNTHETIC
RESINS

SCOPE OF POLISITVE LIST FOR SYNTHETIC RESINS

GROUPING RULE FOR RESIN
26
TABLE 1 (3) MINOR MONOMER LIST, ANNEX I
98% Rule
Polymer ABC not listed in resin lists of Annex I can be

used in food contact if satisfied all three conditions as
below:
1. Polymer AB is listed in PL of Annex I as basic polymer,
2. Monomer A and B in Polymer ABC exceed 98% weight as the
polymer’s structural components,
3. Monomer C is listed in Table 1 (3) minor monomer list of
Annex I.
27
TABLE 2 ADDITIVE LIST, ANNEX I
❖ Scope
*In scope
28
TABLE 2 ADDITIVE LIST, ANNEX I
❖ Exceptional cases in the scope

Catalyst or polymerization aid used in polymerization reaction
→ Risk assessment with reasonable evaluation methods by company itself
Pigment
→ Shall be listed in Table 1 Food Additive list of Order of Enforcement of the Food Sanitation Art MHLW No. 23 1948
→ Or it shall not be eluted into food as per Specifications and Standards for Foods, Food Additives MHLW No. 370 1959
√ Substance as additive with polymer structures

→ Polymeric additive not in resin lists
→ Substance as liquid at room temperature with low viscosity
→ Substance under 1000 Da
√ Dual use additive such as releasing substance in active packaging shall comply with PL of food contact and
food additive
29
MHLW REOPEN THE WINDOW OF SUBMITTING OPINIONS OF PL, JUN. 2020
Based on whether substance is with activity as food contact use in Japan before 31 May 2020, MHLW classified all
the substances not listed in PL into two types as below and seek opinions from public.
 Current substance: With activity as food contact use in Japan before 31 May 2020
1. New submission of non-listed substance
2. Revision of existing substance in PL
Enterprises need to submit the required information and application form to MHLW by email.
 New substance: Without activity as food contact use in Japan before 31 May 2020
1. New submission of non-listed substance
2. Revision of existing substance in PL
Enterprises need to do full dossier as reference of Guideline on risk assessment by May 2019 to MHLW by email.
For new substance, MHLW indicated that enterprises can’t use it legally unless it is added into PL of Annex I.
30
https://www.mhlw.go.jp/stf/newpage_11487.html
MHLW PUBLISH UPDATED PL AND FORMAL APPLICATION FORM
20 JULY 2020
•MHLW published updated positive lists
29 JULY 2020
•MHLW published formal application forms
31
https://www.mhlw.go.jp/stf/newpage_11487.html
03
COMPLIANCE STRATEGY AND
CASE STUDY
COMPLIANCE STRATEGY
• MHLW Regulation: Annex I, Specifications and Standards for Foods, Food

Formula
Additives-Revision, 28 Apr. 2020
review • Confirm the temperature limit and contact food types based on basic resin
• Confirm the max use content and other restrictions of additives
• MHLW Regulation: Specifications and Standards for Foods, Food

Compliance Additives-Revision, 28 Apr. 2020
testing • Including general tests, material tests, elution tests and etc.
• Law: Food Sanitation Art and its Revision

• MHLW Notice: 付け生食発1107 No.1
DoC • No requirements for format
• Claim the compliance status, but no need to clarify the
details of formulation or use content
CASE STUDY
Step 1 Formula review
Example: Plastic product with polypropylene (PP) as base resin

✓ Base resin: Polypropylene (PP)，CAS NO. 9003-07-0
The plastic final product is intended to contact all food types, with no limit of use temperature (Level III), and Resin Group is
Group 6.
✓ One additive: Lactic acid, CAS NO. 50-21-5

The additive can be used in the product with max use content 0.05% in Resin Group 6.

CASE STUDY
Step 2 Compliance Testing
Example: Plastic product with polypropylene (PP) as base resin

✓ Base resin: Polypropylene (PP)，CAS NO. 9003-07-0
The plastic final product is intended to contact all food types, with no limit of use temperature (Level III), and Resin Group is
Group 6.
The following testing need to be done.
Material Test Item Simulant Limit
Total lead, cadmium 100 μg/g
Potassium permanganate consumption Water 10 μg/mL
Heavy metal, as Pb 4% acetic acid 1 μg/ml (as Pb)
Plastic
product with Decolorization test Water/4% acetic acid Negative
PP as base Water 30 μg/mL
resin
4% acetic acid 30 μg/mL
Evaporation residue
20% ethanol 30 μg/mL
N-heptane 30 μg/mL/150 μg/mL
CASE STUDY
Step 3 Declaration of Compliance
Template of DoC

04
ASSOCIATION-JCII
ROLE OF ASSOCATION
MHLW
Mandatory regulations
+ Industrial Associations
Voluntary standards
• Food Sanitation Art-Revision, Law • JETRO-Japan External Trade Organization

No. 46 2018 • JHOSPA-Japan Hygienic Olefin And Styrene
• Plastics
Japan Association
Chemical Innovation and Inspection
• Order of Enforcement of the Food • Institute
JHPVCA-Japan
(JCII) Hygienic PVC Association
Sanitation Art, MHLW No. 23 1948 • JHAVC-Japan Hygienic Association of VC
• JPIMA-Japan Printing Ink Makers Association
• Specifications and Standards for
Foods, Food Additives-Revision, • JPWIA-Japan Petrolatum Wax Industry
Association
28th Apr. 2020
• JAIA-Japan Adhesive Industry Association
• Guideline on GMP, 生食発 0710 • JRMA-Japan Rubber Manufacturers Association
No. 14 2017 • JPA-Japan Paper Association
JAPAN CHEMICAL INNOVATION AND INSPECTION INSTITUTE
• JCII mainly commits to building a communication bridge between the government and enterprises and tries to
collect the information through the supply chain, in order to add more substances to the positive list during
grace period.
• On the effective date of 1 June 2020, JCII established Food Contact Safety Centre to support the implementing work of new
regulations and positive lists.
• JCII will merge three plastic industrial associations on 2021. JCII still adopts the membership system and the current member
in three associations have been included in “Special Group Member”
① JHOSPA
② JHPVCA
③ JHAVC
39
https://www.jcii.or.jp/publics/index/65/
Timeline in Grace Period (Draft)
公历 2020 2021 2022 2023 2024 2025
1 4 7 10 1 4 7 10 1 4 7 10 1 4 7 10 1 4 7 10 1 4 7 10
PL PL PL PL PL PL
Transitional measures
JCII
Set System
Service Service Reg
of DoC Start Phase Ⅰ Start Phase ⅠI ular
Design Data Trial Debug

System base run support
Final confirmation
Formula review as per PL
of non-listed
→ Collect non-listed substance substance
Applic Applic Applic Applic

ApplicApplic
DATA
DATADATA
ation ation ation ationation ation
Confirmation Confirmation
Acceptance letter
letter letter
Collect
information
and review 40
05
SUMMARY
SCOPE OF JAPAN FOOD CONTACT REGULATION SYSTEM
Ink
In indirect
contact layer
Adhesive in multiple
In indirect contact layers
layer in multiple
layers
Plastic
Thermoplastic Rubber
Pigment Additive Thermosetting Thermosetting
plastic elastomer
Glass
Thermoplastic Coating Ceramics
elastomer On paper or
Enamel
other materials/
In multiple layers
Metal
Paper

COMPARISON OF PL IN CHINA, EU AND JAPAN
Whether mentioned in PL JAPAN EU CHINA
Management on Polymer Base on Polymer Base on Monomer Base on Polymer
Max use content √ √ √
SML X √ √
SML(T) X √ √
Intended use condition For each resin Only for some substances Only for some substances
Max use temperature For on each resin Only for some substances Only for some substances
FRF X √ X
Pigment X X √
Resin Group √ With 7 groups X X

43
SUMMARY AND QUESTIONS
• Revision of law and regulation and new positive lists is effective on 1 June 2020 with 5-year grace
period.
• Positive lists includes two resin lists, one minor monomer list and one additive list.
• MHLW still seeks opinions on positive lists and want to cover more substances with activity into
PL. MHLW will continue to update PL during grace period.
• No requirement on format of DOC now.
• JCII will support MHLW to update PL.
Intertek recommends enterprises and companies actively submit opinions of non-listed substances
to MHLW for updating PL. Member of association can catch up the latest plan by JCII.

INTERTEK HERS
CHINA
GLOBAL FOOD
CONTACT SERVICE
INTERTEK GLOBAL FOOD CONTACT SERVICE
• Global Food contact petition/notification service • NIAS screening and risk assessment
• US / EU / China/ Japan • FDA and EU recycled plastic compliance
• JHOSPA and coming Japan positive list
• Global Food contact compliance service • Risk Assessment of Consumer Product
• Testing: China (Taiwan and Hongkong included), EU, • PROP65 Food Packing Compliance
US, Japan and other APAC countries such as South
Korea, India, Vietnam, Thailand, Singapore,
Philippines, Indonesia • Consultancy service
• Ingredient review
• Training
• Migration calculation and modelling
• Newsletter
• DOC 46

INTERTEK JAPAN FOOD CONTACT SERVICE
Declaration
of
Compliance Compliance
Formula
Certificate of
review and
associations,
compliance
eg, JHOSPA,
testing
Submission JAIA
on opinions
of PL to
MHLW
Newsletter

Crystal Liu
+86 21 5339 7931
crystal.yq.liu@intertek.com
www.intertek.com/regulatory/food-contact/
More updates on global food contact

Follow Wechat account of HERS China →_→

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COMPLIANCE STRATEGY OF JAPAN

NEW FOOD CONTACT REGULATIONS

01 Japan New Food Contact System

02 Japan New Positive Lists

03 Compliance Strategy and Case Study

© Intertek 2020. All Rights Reserved. 2

© Intertek 2020. All Rights Reserved. 4

2015.06 2017.06 2018.06 2019.05 2020.04 2020.06.01 2025.05.31

Full Interim Two Revised

© Intertek 2020. All Rights Reserved.

Food Sanitation Art Food Safety Basic Law

New System (New Positive Lists)

MHLW notice No. 196

• Grace Period is 5 years!

MHLW notice No. 195

• Item 3 in Article 18 of Food Sanitation Art

The limit being unlikely to harm human health

Chapter 3 and Chapter 9 are related to FCM!

- Article 18 3rd paragraph added

Chapter 9 Production and Operation

❖ 5-Year Grace Period

All the substances

Chapter I Chapter II Chapter III Chapter IV Chapter V

A. General B. Test C. Test D. Material E. Special F. Product

Revision of MHLW No. 370, 28 April 2020

• Item 8 of A replaces Item 7 and delete Item 7;

• New Item 8 of A for positive lists:

✓ Any substances used in food contact materials and articles shall

✓ Pigment is NOT in the scope of Annex I positive lists.

✓ 98% rule: A exemption for non-authorized basic resins: Find a

For New substance

• Guidelines for Assessment of Human Health Effects of Food

For current substance

• Guideline on Assessment of current substance in Food Apparatus,

Plastic Resin Coating Resin Minor Monomer Additive

List No. Table 1, Annex I Table 2, Annex I

© Intertek 2020. All Rights Reserved. 19

© Intertek 2020. All Rights Reserved. 20

© Intertek 2020. All Rights Reserved. 21

© Intertek 2020. All Rights Reserved. 22

❖ Classification of Synthetic Resins ❖ Comparison

© Intertek 2020. All Rights Reserved. 24

© Intertek 2020. All Rights Reserved. 25

Polymer ABC not listed in resin lists of Annex I can be

❖ Exceptional cases in the scope

√ Substance as additive with polymer structures

• MHLW Regulation: Annex I, Specifications and Standards for Foods, Food

• MHLW Regulation: Specifications and Standards for Foods, Food

• Law: Food Sanitation Art and its Revision

Example: Plastic product with polypropylene (PP) as base resin

✓ One additive: Lactic acid, CAS NO. 50-21-5

© Intertek 2020. All Rights Reserved. 34

Example: Plastic product with polypropylene (PP) as base resin

© Intertek 2020. All Rights Reserved. 36

• Food Sanitation Art-Revision, Law • JETRO-Japan External Trade Organization

Design Data Trial Debug

Applic Applic Applic Applic

© Intertek 2020. All Rights Reserved. 42

Whether mentioned in PL JAPAN EU CHINA

Management on Polymer Base on Polymer Base on Monomer Base on Polymer

Max use content √ √ √

Resin Group √ With 7 groups X X

• No requirement on format of DOC now.