1. AN UPDATE ON EFFORTS FOR
REGULATION OF
FOOD PACKAGING IN JAPAN
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International Symposium SPI (2011)

2. ABOUT US
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Pharmaceutical and Food Safety Bureau
Department of Food Safety
Policy Planning and Communication International Food Planning Coordinator
Division
Office of Port Health Administration
Standards and Evaluation Division Office of Health Policy
on Newly Developed Food
Inspection and Safety Division Office of Import Food Safety
Office of food poisoning information

3. Today’s Topics
!Base of Legislation
!Outline of the regulation of Food
contact Utensils/Packaging
!Safety of Plastic
!The use of recycled materials
!On going and future works
Ministry of Health, Labour and Welfare

4. BASE OF LEGISLATION
Ministry of Health, Labour and Welfare

5. Base of Legislation
Japanese food safety legislation
is based on
“Food Safety Basic Law” (2003)
and
“Food Sanitation Law” (1947)
to protect the health of the people
through the food safety
Ministry of Health, Labour and Welfare

6. Food Safety Basic LawEnacted in May 2003
!Principles of Food Safety
ASSESSMENT
!Purpose MANAGEMENT
!Responsibilities and roles
!Risk Analysis COMMUNICATION
!Food Safety Commission
Established in July 2003
(FSC)
Ministry of Health, Labour and Welfare

7. Framework for Risk Analysis
RISK ASSESSMENT RISK MANAGEMENT
FSC MHLW
•To conduct a risk assessment. Risk management measures for food
•To recommend risk safety under Food Sanitation Law etc.
management agencies to take a
necessary measures, based on MAFF
the risk assessment results.
Risk management measures for
•To manage total risk
agricultural, livestock or fishery
communication including
production
activities of the risk
under Agricultural Chemicals
management agencies etc.
Regulation Law etc.
under Food Safety Basic Law
RISK COMMUNICATION
• Disclosure of information on food safety
• Securing consumers’ opportunities to express their opinions

8. Food Sanitation Law Enacted in Dec 1947
Targets of Regulation by the Law
! Foods and Food additives
! Food-contact Utensils/Packaging
for Foods/Food additives
! Toys for young children
! Detergents for Vegetables/Fruits or Eating Utensils
Enforcement
! Inspection on domestic food-business facilities
! Import notification
! Examination order and Monitoring Testing
! Administrative disposition and other penalty for violation
cases Ministry of Health, Labour and Welfare

9. OUTLINE OF FOOD SAFETY
ON FOOD-CONTACT
UTENSILS/PACKAGING,
UNDER FOOD SANITATION LAW
Ministry of Health, Labour and Welfare

10. Definitions
Food Sanitation Law Article 4 (Definitions)
Utensils: Tableware, kitchen utensils,
machines, implements and other articles,
which come into direct contact with food.
Containers/packaging: Bags, trays, boxes,
bottles, cans, film and other articles
in which foods are offered for trade
Utensils + Containers/packaging
= Food contact articles
Ministry of Health, Labour and Welfare

11. Article 16
Food-contact Utensils/Packaging
! which contain toxic or harmful substance and involve a risk to
human health
! which contact food or food additive and
have a harmful effect on them and involve a risk to human
health
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Ministry of Health, Labour and Welfare

12. Article 18
" Establishment of “specifications and standards”
for utensils and containers/packaging
Specifications
for food-contact utensils/packaging and their materials
Standards
for the production methods of those products
"Product which do not conform to the established
specification
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" NOT be produced by methods that do not conform
to the established standard
Ministry of Health, Labour and Welfare

13. Article 16 vs. Article 18
Maximum
Objective Punishment for
violation cases
To avoid an imminent danger of 2 year imprisonment
Article
human health, and/or
16 such as acute poisoning 2 million yen fine
Requirements for good
quality/production
1 year imprisonment
Article as reasonably achievable
and/or
18 (Including certain of safety 1 million yen fine
margins, NOT harmfulness
criteria)
Ministry of Health, Labour and Welfare

14. Japanese Legislation for Food Contact Materials
Food Sanitation Law
Article 18
Compositional Standards Specifications and Standards
for Milk and Milk Products of Food, Food Additives, etc
Annex 4. Specifications and
Standards of utensils and Section 1 Section 2 Section 3 Section 4 Section 5
Container/Packages of Milk etc Food Utensils and Packages
Food Additives Toys Detergents
and Their Materials
A. Specification of utensils, packages,
and their materials
Sec. 2-1 Sec. 2-2 Sec. 3 B. General test methods of utensils and
Normal liquid milk Fermented milks Formulated packages
Certified milk Lactic acid drinks milk powder C. Reagents, test solutions, etc
Goat milk Milk drinks D. Specifications of utensils and
Skimmed milk Plastic- packages and their raw materials by
Liquid milk PE, PP, PET or PS laminated material
recombined 1. Glass, ceramic and enameled ware
Cream container/packages container
PE-processed /packages 2. Plastics
PE or PET paper Metal can 3. Rubber
container/ packages container/package with sealing of 4. Metal can
PE-processed PE, PP, PS or PET PE or E. Specifications of utensils or packages
paper container/ container/ PET by applications
package packages with F. Standards of manufacture of utensils
Composite aluminum foil and packages
container/ packages

15. SAFETY OF PLASTIC
Ministry of Health, Labour and Welfare

16. Plastic Regulation
Japanese food contact plastics are regulated by
Government (Ministry of Health, Labour
and Welfare, MHLW)
!
Industrial Hygienic Associations
! Government controls mainly final products by
the law.
! Industrial hygienic associations control mainly
materials by their voluntary standards including
positive lists and the certification system.
Ministry of Health, Labour and Welfare

17. Voluntary Standards and Certification System
Instruction by MHW Establishment of Hygienic Association
1. Establishment of Voluntary
Standards Japan Hygienic PVC Association (JHPA) (1967)
2.Establishment of Hygienic PolyVinyl Chloride and the additives (ca.800 substances),
Associations for voluntary ca.200 members
Regulation
Japan Hygienic Olefin and Styrene Plastics
Requirement for substances Association (JHOSPA)(1973)
in Voluntary Standards Resins except for PolyVinyl Chloride and Vinylidene Chloride
(1) Listed in the foreign (ca.30 resins) and the additives (ca.1200 substances),
positive lists ca.800 members
(2) used in the foreign Japan Hygienic Association of Vinylidene
countries Chloride (JHAVC)(1977)
(3) enough toxicological data PolyVinylidene Chloride and the additives
(4) technical utility (ca.700 substances), ca.12 members
(5) essential usage
Covering governmental
specification
Voluntary Standards : Certification System :
Positive list 1 Base polymer (Monomers), Additives
Issue of certification about compliance
Testing Method Material, Migration test
for Voluntary Standards , Use of the Label
Requirement Listed in the Foreign advanced countries, or
TDI/EDI>1 2 mutagenicity test
Objects
Positive list 2 trade names (color materials)
Additives, Compounded , Plastics,
Requirement Compliance for Standards in Color material
Containers/Packaging
testing method ( Lead, Cd, As, Hg, etc.)

18. The Structure of
the voluntarily certification System
Listed in the Positive List
Petitions for being
listed in the Positive
Member List Technical Committee etc.
companies (evaluation)
Hygiene New Resins
Member
Association (Public comment for
companies members)
Petitions for Issue Evaluation
of certification
Voluntary labeling
Issue of certification Regular inspection
Approval of using the Label Occasional inspection
Ministry of Health, Labour and Welfare

19. Plastic regulation in Japan, US, EU
Japan US EU
Specification End test End test SML, OML
test
(Material test
Migration test etc.)
Type of list Negative list Positive list Positive list
(partly)
!Necessary toxic data are decided by Exposure level based on
the migration data in US and EU.
Ministry of Health, Labour and Welfare

20. The problems of the current system
The materials which are considered to
have safety concerns are regulated.
cannot deal with new materials which has
unknown toxicity
Voluntary standards have no legal force
The materials regulated not in Japan but
in EU and US, flow into Japan
Ministry of Health, Labour and Welfare

21. The required issues in a new system
put a priority on
(regulate substances have higher–risk; toxic, high
exposure)
establish cost effective and workable system
clarification of the division of the roles played by
MHLW, FSC, Industrial Association
establish the way to check the compliance
Ministry of Health, Labour and Welfare

22. ENSURE THE SAFETY OF
THE USE OF RECYCLED
MATERIALS
Ministry of Health, Labour and Welfare

23. The use of the recycled material for
Food Packaging
The examples of the use of recycled materials for food packages
PET bottle : chemical recycle
Polystylene tray, PET tray (egg packages, fruit packages): material recycle
Food consumer Used recycler Recycled
packaging Packaging materials
Safety concern : unknown contaminants
Current specification Current specification
Consumers stored detergent in
empty PET bottle
Recyclers spray pesticide to used
PET bottles
unknown contaminant residue
Establishment of
guideline
Ministry of Health, Labour and Welfare

24. Planning the establishment of the guideline for
the use of the recycled materials for food packaging
Used Packages
Contamination of unintended
• source control harmful substances
recover
• Sorting procedure •Pesticide, detergent , heavy chemicals
Apply new technology
•Reprocessing •Sorting, washing, reforming
Reprocessing •Surrogate contaminant testing Consideration of Requirement for
Routine system testing
Management •Ensure the ability of decontamination
GMP,QC) Material testing Migration testing
• Limitation of food type or
conditions of use •Tests for substances which have high
Recycled possibility to be contained in------
materials • The use of Functional barrier
Validation for Material and thickness
of barrier
Recycled packages
Apply for Food Sanitation Law
Article 16, Article 18
Ministry of Health, Labour and Welfare

25. Ongoing & Future Works
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