japan: update on regulation of food packaging 2011
TRANSCRIPT
1
AN UPDATE ON EFFORTS FOR
REGULATION OF
FOOD PACKAGING IN JAPAN
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International Symposium SPI (2011)
ABOUT US
!"#"$%&'()*(+,-.%/0(1-2)3& -#4(5,.*-&,(6!+157
Pharmaceutical and Food Safety Bureau
Department of Food Safety
Policy Planning and Communication Division
Office of Port Health Administration
Standards and Evaluation Division Office of Health Policy on Newly Developed Food
International Food Planning Coordinator
Inspection and Safety Division Office of Import Food Safety
Office of food poisoning information
1
AN UPDATE ON EFFORTS FOR
REGULATION OF
FOOD PACKAGING IN JAPAN
!"#"$$%&'(&')*'+*,$')*$-.'/0'&"1)$2".","1)3$245'+&64)&$17$811*$('74&93$!")",&+9$17$:4'/&;3$<'=10+$')*$>4/7'+43$?'5')
International Symposium SPI (2011)
ABOUT US
!"#"$%&'()*(+,-.%/0(1-2)3& -#4(5,.*-&,(6!+157
Pharmaceutical and Food Safety Bureau
Department of Food Safety
Policy Planning and Communication Division
Office of Port Health Administration
Standards and Evaluation Division Office of Health Policy on Newly Developed Food
International Food Planning Coordinator
Inspection and Safety Division Office of Import Food Safety
Office of food poisoning information
2
!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
Today’s Topics
Ministry of Health, Labour and Welfare
BASE OF LEGISLATION
Ministry of Health, Labour and Welfare
2
!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
Today’s Topics
Ministry of Health, Labour and Welfare
BASE OF LEGISLATION
Ministry of Health, Labour and Welfare
3
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
Base of Legislation
Ministry of Health, Labour and Welfare
!Food Safety Commission
(FSC)
ASSESSMENT
MANAGEMENT
COMMUNICATION
!Principles of Food Safety
!Purpose
!Responsibilities and roles
!Risk Analysis
Food Safety Basic Law
Ministry of Health, Labour and Welfare
Enacted in May 2003
Established in July 2003
3
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
Base of Legislation
Ministry of Health, Labour and Welfare
!Food Safety Commission
(FSC)
ASSESSMENT
MANAGEMENT
COMMUNICATION
!Principles of Food Safety
!Purpose
!Responsibilities and roles
!Risk Analysis
Food Safety Basic Law
Ministry of Health, Labour and Welfare
Enacted in May 2003
Established in July 2003
4
RISK COMMUNICATION
• Disclosure of information on food safety• Securing consumers’ opportunities to express their opinions
FSC MHLW
MAFF
Risk management measures for food safety under Food Sanitation Law etc.
Risk management measures for agricultural, livestock or fishery production under Agricultural Chemicals Regulation Law etc.
•To conduct a risk assessment. •To recommend risk management agencies to take a necessary measures, based on the risk assessment results.
•To manage total risk communication including activities of the risk management agencies etc. under Food Safety Basic Law
Framework for Risk Analysis
RISK ASSESSMENT RISK MANAGEMENT
Food Sanitation Law
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
casesMinistry of Health, Labour and Welfare
Enacted in Dec 1947
4
RISK COMMUNICATION
• Disclosure of information on food safety• Securing consumers’ opportunities to express their opinions
FSC MHLW
MAFF
Risk management measures for food safety under Food Sanitation Law etc.
Risk management measures for agricultural, livestock or fishery production under Agricultural Chemicals Regulation Law etc.
•To conduct a risk assessment. •To recommend risk management agencies to take a necessary measures, based on the risk assessment results.
•To manage total risk communication including activities of the risk management agencies etc. under Food Safety Basic Law
Framework for Risk Analysis
RISK ASSESSMENT RISK MANAGEMENT
Food Sanitation Law
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
casesMinistry of Health, Labour and Welfare
Enacted in Dec 1947
5
OUTLINE OF FOOD SAFETY
ON FOOD-CONTACT
UTENSILS/PACKAGING, UNDER FOOD SANITATION LAW
Ministry of Health, Labour and Welfare
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
Ministry of Health, Labour and Welfare
Utensils + Containers/packaging = Food contact articles
5
OUTLINE OF FOOD SAFETY
ON FOOD-CONTACT
UTENSILS/PACKAGING, UNDER FOOD SANITATION LAW
Ministry of Health, Labour and Welfare
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
Ministry of Health, Labour and Welfare
Utensils + Containers/packaging = Food contact articles
6
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
"Establishment of “specifications and standards”
for utensils and containers/packaging!!!!Specifications
for food-contact utensils/packaging and their materials
!!!!Standardsfor the production methods of those products
Article 18
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" NOT be produced by methods that do not conform to the established standard
"Product which do not conform to the established specification
Ministry of Health, Labour and Welfare
6
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
"Establishment of “specifications and standards”
for utensils and containers/packaging!!!!Specifications
for food-contact utensils/packaging and their materials
!!!!Standardsfor the production methods of those products
Article 18
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" NOT be produced by methods that do not conform to the established standard
"Product which do not conform to the established specification
Ministry of Health, Labour and Welfare
7
Article 16 vs. Article 18
ObjectiveMaximum
Punishment for violation cases
Article 16
To avoid an imminent danger of human health,
such as acute poisoning
2 year imprisonment and/or
2 million yen fine
Article 18
Requirements for good quality/production
as reasonably achievable
(Including certain of safety margins, NOT harmfulness
criteria)
1 year imprisonment and/or
1 million yen fine
Ministry of Health, Labour and Welfare
Compositional Standardsfor Milk and Milk Products
Annex 4. Specifications and Standards of utensils and Container/Packages of Milk etc and Their Materials
PE or PET container/ packagesPE-processed
paper container/ packageComposite
container/ packages
Sec. 2-2Fermented milksLactic acid drinksMilk drinks
Sec. 3Formulated milk powder
PE, PP, PET or PS container/packagesPE-processed
paper container/packagePE, PP, PS or PET
container/ packages with aluminum foil
Plastic-laminated container/packagesMetal can
with sealing of PE or PET
Specifications and Standardsof Food, Food Additives, etc
Section 1
Food
Section 2Food
Additives
Section 3Utensils and Packages
Section 4
Toys
Section 5
Detergents
A. Specification of utensils, packages, and their materials
B. General test methods of utensils and packages
C. Reagents, test solutions, etcD. Specifications of utensils and
packages and their raw materials by material
1. Glass, ceramic and enameled ware2. Plastics 3. Rubber 4. Metal can
E. Specifications of utensils or packages by applications
F. Standards of manufacture of utensils and packages
Food Sanitation Law
Sec. 2-1Normal liquid milkCertified milkGoat milkSkimmed milkLiquid milk
recombinedCream
Japanese Legislation for Food Contact Materials
Article 18
7
Article 16 vs. Article 18
ObjectiveMaximum
Punishment for violation cases
Article 16
To avoid an imminent danger of human health,
such as acute poisoning
2 year imprisonment and/or
2 million yen fine
Article 18
Requirements for good quality/production
as reasonably achievable
(Including certain of safety margins, NOT harmfulness
criteria)
1 year imprisonment and/or
1 million yen fine
Ministry of Health, Labour and Welfare
Compositional Standardsfor Milk and Milk Products
Annex 4. Specifications and Standards of utensils and Container/Packages of Milk etc and Their Materials
PE or PET container/ packagesPE-processed
paper container/ packageComposite
container/ packages
Sec. 2-2Fermented milksLactic acid drinksMilk drinks
Sec. 3Formulated milk powder
PE, PP, PET or PS container/packagesPE-processed
paper container/packagePE, PP, PS or PET
container/ packages with aluminum foil
Plastic-laminated container/packagesMetal can
with sealing of PE or PET
Specifications and Standardsof Food, Food Additives, etc
Section 1
Food
Section 2Food
Additives
Section 3Utensils and Packages
Section 4
Toys
Section 5
Detergents
A. Specification of utensils, packages, and their materials
B. General test methods of utensils and packages
C. Reagents, test solutions, etcD. Specifications of utensils and
packages and their raw materials by material
1. Glass, ceramic and enameled ware2. Plastics 3. Rubber 4. Metal can
E. Specifications of utensils or packages by applications
F. Standards of manufacture of utensils and packages
Food Sanitation Law
Sec. 2-1Normal liquid milkCertified milkGoat milkSkimmed milkLiquid milk
recombinedCream
Japanese Legislation for Food Contact Materials
Article 18
8
SAFETY OF PLASTIC
Ministry of Health, Labour and Welfare
Japanese food contact plastics are regulated by
Government (Ministry of Health, Labourand 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.
Plastic Regulation
Ministry of Health, Labour and Welfare
8
SAFETY OF PLASTIC
Ministry of Health, Labour and Welfare
Japanese food contact plastics are regulated by
Government (Ministry of Health, Labourand 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.
Plastic Regulation
Ministry of Health, Labour and Welfare
9
Certification System :Issue of certification about compliance
for Voluntary Standards , Use of the Label
Objects
Additives, Compounded , Plastics,
Containers/Packaging
Certification System :Issue of certification about compliance
for Voluntary Standards , Use of the Label
Objects
Additives, Compounded , Plastics,
Containers/Packaging
Voluntary Standards and Certification System
Establishment of Hygienic Association
Japan Hygienic PVC Association (JHPA) (1967)PolyVinyl Chloride and the additives (ca.800 substances),
ca.200 members
Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA)(1973)
Resins except for PolyVinyl Chloride and Vinylidene Chloride(ca.30 resins) and the additives (ca.1200 substances), ca.800 members
Japan Hygienic Association of VinylideneChloride (JHAVC)(1977)PolyVinylidene Chloride and the additives
(ca.700 substances), ca.12 members
Establishment of Hygienic Association
Japan Hygienic PVC Association (JHPA) (1967)PolyVinyl Chloride and the additives (ca.800 substances),
ca.200 members
Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA)(1973)
Resins except for PolyVinyl Chloride and Vinylidene Chloride(ca.30 resins) and the additives (ca.1200 substances), ca.800 members
Japan Hygienic Association of VinylideneChloride (JHAVC)(1977)PolyVinylidene Chloride and the additives
(ca.700 substances), ca.12 members
Instruction by MHW1. Establishment of Voluntary
Standards2.Establishment of Hygienic Associations for voluntary Regulation
Requirement for substances in Voluntary Standards(1) Listed in the foreign
positive lists(2) used in the foreign
countries(3) enough toxicological data(4) technical utility(5) essential usage
Instruction by MHW1. Establishment of Voluntary
Standards2.Establishment of Hygienic Associations for voluntary Regulation
Requirement for substances in Voluntary Standards(1) Listed in the foreign
positive lists(2) used in the foreign
countries(3) enough toxicological data(4) technical utility(5) essential usage
Voluntary Standards :Positive list 1 Base polymer (Monomers), Additives
Testing Method Material, Migration test
Requirement Listed in the Foreign advanced countries, or
TDI/EDI>1 2 mutagenicity test
Positive list 2 trade names (color materials)
Requirement Compliance for Standards in Color material
testing method ( Lead, Cd, As, Hg, etc.)
Voluntary Standards :Positive list 1 Base polymer (Monomers), Additives
Testing Method Material, Migration test
Requirement Listed in the Foreign advanced countries, or
TDI/EDI>1 2 mutagenicity test
Positive list 2 trade names (color materials)
Requirement Compliance for Standards in Color material
testing method ( Lead, Cd, As, Hg, etc.)
Covering governmental specification
The Structure of the voluntarily certification System
Hygiene Association
Member companies
Petitions for being listed in the Positive List
Petitions for being listed in the Positive List
Listed in the Positive ListListed in the Positive List
Regular inspectionOccasional inspection
Member companies
Petitions for Issue of certificationPetitions for Issue of certification
Technical Committee etc.(evaluation)New Resins(Public comment for members)
Issue of certificationApproval of using the Label
Evaluation
Voluntary labelingVoluntary labeling
Ministry of Health, Labour and Welfare
9
Certification System :Issue of certification about compliance
for Voluntary Standards , Use of the Label
Objects
Additives, Compounded , Plastics,
Containers/Packaging
Certification System :Issue of certification about compliance
for Voluntary Standards , Use of the Label
Objects
Additives, Compounded , Plastics,
Containers/Packaging
Voluntary Standards and Certification System
Establishment of Hygienic Association
Japan Hygienic PVC Association (JHPA) (1967)PolyVinyl Chloride and the additives (ca.800 substances),
ca.200 members
Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA)(1973)
Resins except for PolyVinyl Chloride and Vinylidene Chloride(ca.30 resins) and the additives (ca.1200 substances), ca.800 members
Japan Hygienic Association of VinylideneChloride (JHAVC)(1977)PolyVinylidene Chloride and the additives
(ca.700 substances), ca.12 members
Establishment of Hygienic Association
Japan Hygienic PVC Association (JHPA) (1967)PolyVinyl Chloride and the additives (ca.800 substances),
ca.200 members
Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA)(1973)
Resins except for PolyVinyl Chloride and Vinylidene Chloride(ca.30 resins) and the additives (ca.1200 substances), ca.800 members
Japan Hygienic Association of VinylideneChloride (JHAVC)(1977)PolyVinylidene Chloride and the additives
(ca.700 substances), ca.12 members
Instruction by MHW1. Establishment of Voluntary
Standards2.Establishment of Hygienic Associations for voluntary Regulation
Requirement for substances in Voluntary Standards(1) Listed in the foreign
positive lists(2) used in the foreign
countries(3) enough toxicological data(4) technical utility(5) essential usage
Instruction by MHW1. Establishment of Voluntary
Standards2.Establishment of Hygienic Associations for voluntary Regulation
Requirement for substances in Voluntary Standards(1) Listed in the foreign
positive lists(2) used in the foreign
countries(3) enough toxicological data(4) technical utility(5) essential usage
Voluntary Standards :Positive list 1 Base polymer (Monomers), Additives
Testing Method Material, Migration test
Requirement Listed in the Foreign advanced countries, or
TDI/EDI>1 2 mutagenicity test
Positive list 2 trade names (color materials)
Requirement Compliance for Standards in Color material
testing method ( Lead, Cd, As, Hg, etc.)
Voluntary Standards :Positive list 1 Base polymer (Monomers), Additives
Testing Method Material, Migration test
Requirement Listed in the Foreign advanced countries, or
TDI/EDI>1 2 mutagenicity test
Positive list 2 trade names (color materials)
Requirement Compliance for Standards in Color material
testing method ( Lead, Cd, As, Hg, etc.)
Covering governmental specification
The Structure of the voluntarily certification System
Hygiene Association
Member companies
Petitions for being listed in the Positive List
Petitions for being listed in the Positive List
Listed in the Positive ListListed in the Positive List
Regular inspectionOccasional inspection
Member companies
Petitions for Issue of certificationPetitions for Issue of certification
Technical Committee etc.(evaluation)New Resins(Public comment for members)
Issue of certificationApproval of using the Label
Evaluation
Voluntary labelingVoluntary labeling
Ministry of Health, Labour and Welfare
10
Plastic regulation in Japan, US, EU
Ministry of Health, Labour and Welfare
Japan US EU
Specification test(Material test
Migration test etc.)
End test End test SML, OML
Type of list Negative list
(partly)
Positive list Positive list
!Necessary toxic data are decided by Exposure level based on the migration data in US and EU.
!!!!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
The problems of the current system
Ministry of Health, Labour and Welfare
10
Plastic regulation in Japan, US, EU
Ministry of Health, Labour and Welfare
Japan US EU
Specification test(Material test
Migration test etc.)
End test End test SML, OML
Type of list Negative list
(partly)
Positive list Positive list
!Necessary toxic data are decided by Exposure level based on the migration data in US and EU.
!!!!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
The problems of the current system
Ministry of Health, Labour and Welfare
11
!!!!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
The required issues in a new system
Ministry of Health, Labour and Welfare
ENSURE THE SAFETY OF
THE USE OF RECYCLED
MATERIALS
Ministry of Health, Labour and Welfare
11
!!!!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
The required issues in a new system
Ministry of Health, Labour and Welfare
ENSURE THE SAFETY OF
THE USE OF RECYCLED
MATERIALS
Ministry of Health, Labour and Welfare
12
Ministry of Health, Labour and Welfare
Current specification
The use of the recycled material forFood Packaging
Food packaging
Recycled materials
Establishment of guideline
The examples of the use of recycled materials for food packagesPET bottle : chemical recycle
Polystylene tray, PET tray (egg packages, fruit packages): material recycle
The examples of the use of recycled materials for food packagesPET bottle : chemical recycle
Polystylene tray, PET tray (egg packages, fruit packages): material recycle
Safety concern : unknown contaminantsSafety concern : unknown contaminants
Used Packaging
Recyclers spray pesticide to used PET bottles
Consumers stored detergent in empty PET bottle
Current specification
unknown contaminant residue
consumer recycler
Ministry of Health, Labour and Welfare
recover
• source control
• Sorting procedure
Reprocessing
system
•Reprocessing•Surrogate contaminant testing
Recycledmaterials
• Limitation of food type or conditions of use
• The use of Functional barrier
RoutineManagement
GMP,QC)
Used Packages
Recycled packages
Planning the establishment of the guideline for the use of the recycled materials for food packaging
•Tests for substances which have high possibility to be contained in------
Validation for Material and thickness of barrier
Material testing Migration testing
Apply for Food Sanitation Law
Consideration of Requirement for testing
Apply new technology
Contamination of unintended harmful substances
•Sorting, washing, reforming
•Pesticide, detergent , heavy chemicals
•Ensure the ability of decontamination
Article 16, Article 18
12
Ministry of Health, Labour and Welfare
Current specification
The use of the recycled material forFood Packaging
Food packaging
Recycled materials
Establishment of guideline
The examples of the use of recycled materials for food packagesPET bottle : chemical recycle
Polystylene tray, PET tray (egg packages, fruit packages): material recycle
The examples of the use of recycled materials for food packagesPET bottle : chemical recycle
Polystylene tray, PET tray (egg packages, fruit packages): material recycle
Safety concern : unknown contaminantsSafety concern : unknown contaminants
Used Packaging
Recyclers spray pesticide to used PET bottles
Consumers stored detergent in empty PET bottle
Current specification
unknown contaminant residue
consumer recycler
Ministry of Health, Labour and Welfare
recover
• source control
• Sorting procedure
Reprocessing
system
•Reprocessing•Surrogate contaminant testing
Recycledmaterials
• Limitation of food type or conditions of use
• The use of Functional barrier
RoutineManagement
GMP,QC)
Used Packages
Recycled packages
Planning the establishment of the guideline for the use of the recycled materials for food packaging
•Tests for substances which have high possibility to be contained in------
Validation for Material and thickness of barrier
Material testing Migration testing
Apply for Food Sanitation Law
Consideration of Requirement for testing
Apply new technology
Contamination of unintended harmful substances
•Sorting, washing, reforming
•Pesticide, detergent , heavy chemicals
•Ensure the ability of decontamination
Article 16, Article 18
13
Ongoing & Future Works
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13
Ongoing & Future Works
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Ministry of Health, Labour and Welfare
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Ministry of Health, Labour and Welfare