Japan: Update on regulation of food packaging 2011


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Japan: Update on regulation of food packaging 2011

  1. 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)
  2. 2. ABOUT US!"#"$%&()*(+,-.%/0(1-2)3& -#4(5,.*-&,(6!+157Pharmaceutical 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. 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. 4. BASE OF LEGISLATION Ministry of Health, Labour and Welfare
  5. 5. Base of LegislationJapanese food safety legislationis 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. 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. 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. 8. Food Sanitation Law Enacted in Dec 1947Targets 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 UtensilsEnforcement ! 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
  10. 10. DefinitionsFood 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. 11. Article 16Food-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 !"# !"#$%&(# !"$ !"#)*%+,"#%*#-.)%*/"#0%*# /1"#)+*)%$"#%0#.2*3"/-45(# !"$ !"#+$"#-4#0%%#!+$-4"$$ Ministry of Health, Labour and Welfare
  12. 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 !"# !"#$%&(#!"$ !"#)*%+,"#%*#-.)%*/"#0%*#/1"#)+*)%$"#%0# .2*3"/-45(#!"$ !"#+$"#-4#0%%#!+$-4"$$" NOT be produced by methods that do not conform to the established standard Ministry of Health, Labour and Welfare
  13. 13. Article 16 vs. Article 18 Maximum Objective Punishment for violation cases To avoid an imminent danger of 2 year imprisonmentArticle human health, and/or 16 such as acute poisoning 2 million yen fine Requirements for good quality/production 1 year imprisonmentArticle 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. 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, etcAnnex 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 materialsSec. 2-1 Sec. 2-2 Sec. 3 B. General test methods of utensils andNormal liquid milk Fermented milks Formulated packagesCertified milk Lactic acid drinks milk powder C. Reagents, test solutions, etcGoat milk Milk drinks D. Specifications of utensils andSkimmed milk Plastic- packages and their raw materials byLiquid milk PE, PP, PET or PS laminated material recombined 1. Glass, ceramic and enameled wareCream container/packages container PE-processed /packages 2. Plastics PE or PET paper Metal can 3. Rubbercontainer/ packages container/package with sealing of 4. Metal can PE-processed PE, PP, PS or PET PE or E. Specifications of utensils or packagespaper container/ container/ PET by applicationspackage packages with F. Standards of manufacture of utensils Composite aluminum foil and packagescontainer/ packages
  15. 15. SAFETY OF PLASTIC Ministry of Health, Labour and Welfare
  16. 16. Plastic RegulationJapanese 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. 17. Voluntary Standards and Certification SystemInstruction 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 PlasticsRequirement 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 specificationVoluntary 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. 18. The Structure ofthe voluntarily certification System Listed in the Positive List Petitions for being listed in the PositiveMember List Technical Committee etc.companies (evaluation) Hygiene New ResinsMember Association (Public comment forcompanies 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. 19. Plastic regulation in Japan, US, EU Japan US EUSpecification End test End test SML, OMLtest(Material testMigration test etc.)Type of list Negative list Positive list Positive list (partly)!Necessary toxic data are decided by Exposure level based onthe migration data in US and EU. Ministry of Health, Labour and Welfare
  20. 20. The problems of the current system The materials which are considered tohave safety concerns are regulated. cannot deal with new materials which hasunknown toxicity Voluntary standards have no legal force The materials regulated not in Japan butin EU and US, flow into Japan Ministry of Health, Labour and Welfare
  21. 21. The required issues in a new system put a priority on(regulate substances have higher–risk; toxic, highexposure) establish cost effective and workable system clarification of the division of the roles played byMHLW, FSC, Industrial Association establish the way to check the compliance Ministry of Health, Labour and Welfare
  22. 22. ENSURE THE SAFETY OFTHE USE OF RECYCLEDMATERIALS Ministry of Health, Labour and Welfare
  23. 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 contaminantsCurrent 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. 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 testingManagement •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. 25. Ongoing & Future Works!"#"$%$#& &# ! "#$%"&#%(&)*+,-./-0&"#"1023)/4)0-#53)4678986#0230&5 (3)&# ()*"&+,% - ! "#$%"&#%(&)*+,-./-0&"#"1023)/4)0-#5346789:&#<".65-=4"#-03 4-)3;"#023.-03)0)5&3#0&1&51&#;&#%) ! 0"2-=>"#&?3)<35&1&5-0&"#)1"=<-5*-%&#%"1)">3 8<35&1&5-0&"#) >&.*<=";/50))/52-)4/003=:5233)3:6"%/=0305@1"=<-5*-%&#%"1 A&0202")31"=<-5*-%&#%"1"023=%3#3=-.<=";/50).)%/0*1,234# ! 0"/<;-0303)0&#%>302";)-#;523>&5-.=3-%3#0)1"= 03)0&#% Ministry of Health, Labour and Welfare
  26. 26. 56-78 9:;<:= 9:;= 5>?@-7A -55@75>:7B Ministry of Health, Labour and Welfare