November 3. 2017
M.Shigekura, JHOSPA
The role of private sectorin FCM management in Japan
The 5th Food Contact Material Safety Symposium, Xi’an
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Current Legal Regulatory Scheme in Japan
2 Voluntary Management Rules of JHOSPA
3
AGENDA
How Should the Private Sector be Involved in the Restrictions?- Opinion of JHOSPA -
1
This presentation contains some tentative translated excerpt of official documents prepared by lecturer.Please check genuine Japanese version before legal action.
Relationship between National Legal Regulations and Private Voluntary Management Rules
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Current Legal Regulatory Scheme in Japan
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4Food Sanitation Act
Chapter I General ProvisionsArticle 1, 3
Chapter II Food and AdditivesChapter III Utensils and Containers and Packaging
Article 15 principle on utensils and containers and packaging used in business
Article 16 restrict the sales of toxic or harmful utensils or containers and packaging
Article 17 prohibit the sales of specific utensils or containers and packaging
Article 18 establish standards for the utensils or containers and packaging, or the raw materials
Chapter IV Labeling and AdvertisingChapter V Japanese Standards of Food AdditivesChapter VI Guidelines and Plans for Monitoring and GuidanceChapter VII Inspections
Article 26, 27, 28
Chapter VIII Registered Conformity Assessment BodiesChapter IX Business
Article 55
Chapter X Miscellaneous ProvisionsArticle 58
Chapter XI Penal ProvisionsArticle 72,73
Supplementary Provisions
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5Specifications and Standards
Food Sanitation ActArticle18
Notification of Specifications and Standards of Food, Food
Additives, etc.
Ministerial Ordinance on Milk and Milk products Concerning Compositional Standards, etc.
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6Specifications and Standards
Specifications and Standards of Food, Food Additives, etc.MHW Notification No.370, (Dec. 28, 1959)Section 3, Utensils, Containers and Packaging
A. General Specifications8 articles
D. Specifications by Material2. Plastics
3 articles for general and14 articles for individual resins
E. Specifications by applications5 articles
F. Standards of manufacture5 articles
http://www.mhlw.go.jp/english/topics/foodsafety/containers/dl/04.pdfA4size 55pages, 910Kb in PDF file
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7Specifications by Material
materialspecification
Material test Elution test
PlasticsGeneral Cd, Pb
Heavy Metals,Potassium Permanganate Consumption
Individual Catalyst etc. Monomer,Evaporation Residue
Material test : measuring the contents of components in the sampleElution test : measuring the amounts of components eluted from a sample under
specified conditions
・Limits of content or elution amount are defined in some substances with remarkable toxicity.
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8Specifications by Individual ResinsResins of utensils and containers/packages Material tests Elution tests
Phenol resin, melamine resin, urea resin - Phenol, formaldehyde and evaporation residue
Synthetic resin with formaldehyde as raw material - formaldehyde and evaporation residue
Polyvinyl chloride Dibutyl tin compound, cresol phosphate ester and vinyl chloride Evaporation residue
Polyethylene and polypropylene - Evaporation residue
Polystyrene volatile matters Evaporation residue
Polyvinylidene chloride Barium and vinylidene chloride Evaporation residue
Polyethylene terephthalate - Antimony, germanium and evaporation residue
Polymethyl methacrylate - Methyl methacrylate and evaporation residue
Nylon - Caprolactam and evaporation residue
Polymethylpentene - Evaporation residue
Polycarbonate Bisphenol A, diphenyl carbonate and amines Bisphenol A and evaporation residue
Polyvinyl alcohol - Evaporation residue
Polylactic acid - Total lactic acid and evaporation residue
Polyethylene naphthalate - Germanium and evaporation residue
14 categories of resins 9 types of testing 9 types of testing
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9Legal Regulatory Scheme in Japan ispurely “Negative”?
These specifications and standards in Japan are called as “Negative List “ style. The reasons might be,1. Listing up actions which are not allowed.2. Listing up when they are considered as harmful or possibly
harmful.
The specifications by individual resins have a little different aspect. The initiation to list up some actions on the new resins is the development of the resin or wide expansion of the resin in production or consumption not the acknowledgement of the possible harm.
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Voluntary Management Rules of JHOSPA
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11Restriction Scheme in Japan
Hybrid
Legal Regulations
Japanese Government (MHLW), Local Governments
• Prohibition provisions• Specifications and
standards• Monitoring and
supervision
Voluntary Management Rules
Industry Organizations(3 Hygienic Associations)
• Voluntary standards(Positive lists, hygienic test methods)
• Confirmation certification service
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12Features of Voluntary Management Rules of JHOSPA (Voluntary Standards + Confirmation Certification Service) - (1)
FastListing to the positive list (PL) About 2 months
Removal from the PL(In case of safety problemsetc.)
Within 1month
Issuance of Confirmation Certificate
About 1month
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13
By limiting the amount of additives that can be easily employed in formula design or manufacturing management, controlling migration is facilitated.
It is not necessary to exchange trade secrets of components/formulae between upstream and downstream companies.
Features of Voluntary Management Rules of JHOSPA (Voluntary Standards + Confirmation Certification Service) - (2)
Easy to useand follow on site
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14Background to the Introduction of Voluntary Management Rules by JHOSPA
Request from the MHW
• Increase in the amount and types of plastics used.
• Cooperation for national development of individual resin specifications and the development, observance and operation of voluntary management rules on additives.
Establishment of the association
• Includes the entire supply chain, as well as the food industry.
• Second hygienic association after the Japan Hygienic PVC Association (JHPA).
Adoption of the FDA method for the development of
private voluntary standards
• At this time, the FDA was the only organization worldwide to apply additive restrictions.
• Certification and PL mark indication rules were alsoestablished.
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15Covered Resins by Voluntary Management Rules of JHOSPA
Sept. 1971Request for cooperation from MHW
Polyethylene (PE)
Sept. 1973Establishment of JHOSPA
1977-80
1980-81
1983
1983
1988-90
Polypropylene (PP) Polystyrene (PS)
AS resin (AS) ABS resin (ABS)
Polymethylmethacrylate (PMMA)
Polymethylpentene(PMP)
Butadiene resin (BDR) Nylon resin (PA)
Polybutene-1(PB-1)
Polyethylene terephthalate (PET)
Polycarbonate (PC)Polyvinylalcohol(PVA)
Polyacetal (POM)Polyphenylene ether(PPE)
Polyacrylonitrile(PAN)
Fluorocarbon resin(FR)
Polybutylene terephthalate (PBT)
Methylmethacrylate-styrene resin (MS)
Polyarylsulfone(PASF)
Polyarylate (PAR)
1991-2007
2008
Polyhydroxybenzoic acid (HBP)
Polyetherimide (PEI)Polycyclohexylenedimethylene terephthalate (PCT)
Polyethylene naphthalate (PEN)
Polyester carbonate(PPC)
Ethylene/tetracyclododecene polymer (E/TD)
Polylactic acid (PLA)Polybutylenesuccinate(PBS)
Ethylene/2-norbornene polymer (E/NB)
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16Positive List of JHOSPA
Number of substances on our PL: 1,166Category Type Number of
substancesSynthetic resin Base polymer 30
Monomer 139
Catalyzer/adjuster 83
Additive and embrocation
Stabilizer 148
Surfactant 81
Lubricant 88
Filler 71
Foaming agent 9
Polymer additive 132
Radical initiator 39
Other additives 95
Colorant 251
Total 1,166
As of March 2016
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17Listing to our Positive List
Listing of a base polymer to our PL
• To define the base polymer, characteristics including the range,specification and the basic additives used in the resin are specified in the PL.
• The hygienic test method of the base polymer is defined.
• The evaluation method for when the additives of the base polymer are listedto our PL is determined.
Listing of an additive to our PL
• Additives that can be used are specified by base polymer. Limitations on the amount are described, if necessary.
• Limitations on the contact food types and on the operating temperature ranges are described if necessary.
• The definition of the base polymer is clarified by evaluating the monomers, copolymerization components, catalyzers, and so on, using the additives’ evaluation method,within a range that can be treated as identical to the base polymer specification.
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18
When new regulations are enforced, or any suspected safety information is obtained, additional limitations will be implemented or the listing will be removed.
Listing to our Positive List
In terms of the actual examining work for listing, the major parts are1) Expansion of the listed content2) Addition of target base
polymers3) Description of the variety of
substances which can be handled in the same way.
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19Conditions for Listng to our Positive List
1 Almost no elution or elution is too small to affect human health.
It is not judged to be carcinogenic.2It has technical utility as an additive.3
The listing methodology which utilizes elution properties and accepts rational judgment is common worldwide.
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20Tests Used for PL Judgments in JHOSPA
Test Condition Test Purpose
Toxicity Test
Acute Toxicity Test (Rat LD50) Presence or absence of acute toxicity
90 day subacute toxicity test (Rat oral intake) Calculation of tolerable daily intake (TDI)
Mutagenicity test
Ames test Screening of presence or absence of carcinogenicity(Only non-carcinogenic substances should be accepted)
Chromosomal abnormality test orMouse lymphoma TK test
Elution test40 °C x 10 d60 °C x 60 min90 °C x 30 min110 °C x 10 min(Boiling point x 90 min)
The test condition and the pseudo-food solvent shall be selected according to the conditions of intended use.
Calculation of estimated daily intake (EDI)• Room
temperature,long-term
• 70 °C or less• 100 °C or less• Over 100 °C
• Heptane (Oily food)• 20% ethanol
(Alcoholic food)• Water (Aqueous food)• 4% acetic acid (Acidic
food)
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21Structure of the JHOSPA Positive List
Note 1) Currently, the JHOSPA does not provide the positive list to companies other than the JHOSPA members. The list is partly available as reference information for the voluntary management guideline notification of the Health, Labour and Welfare Ministry.
Note 2) The excerpt on this page represents the format of the positive list as an image and does not ensure that the content is identical to that of the actual positive list.
Description etc. of Positive List Management MethodDescription etc. of Positive List Management Method
Resin name ×30 kinds
Description of the range of the base polymer
Description of specifications of the base polymer
Table of additives which can be used
Function ×10 categories (9 functions and 1 FCN referenced)
PL No. ×0~50 additives varied from resins and functions
Additive name, Additive amount limitation etc.
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22JHOSPA Confirmation Certification Service
Number of confirmation certification registrations 13,399Number of issued certificates About 5,000 per year
As of March 31, 2017
Our certification means that the JHOSPA has confirmed that the food utensils/product, containers and packaging, and their raw materials1) conform to our voluntary
standards and2) pass the hygienic test.
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23JHOSPA Voluntary Management Scheme is purely “Positive”?
JHOSPA voluntary management scheme uses a list named “Positive List” and is sometimes called as “Positive List” style.
However, there is a subtle difference from the legal positive list style scheme in the US or EU. JHOSPA scheme is voluntary base inner rule of the private companies,
JHOSPA scheme restricts the usage of non-listed materials just when member company wants to get a certificate. If the member does not want to get a certificate, he may use any material for production.
Offering a merit of certificate, JHOSPA scheme is working
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Relationship between National Legal Regulations and Private Voluntary Management Rules
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25Relationship between Legal Regulations and Voluntary Management Rules
Mutually complementary
Advantage of Voluntary Management Rules
• Fast development
• Realistic for businesses
• Facilitation on maintenance and development of rules by participant’s Incentives
Advantage of Legal Regulations
• Coercive power
• Credibility for third parties
• Currently, in Japan, risk assessment and risk management are separated and verification of validity is achieved by role sharing.
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26Collaboration between 2 schemes
Voluntary Standards
1971
1977
1980
1980
1980
1981
1990
2002
1973-2008
Legal Notification
1979
1982
1980
1982
1994
1994
2016
2007
Not established yet
PE, PP, PS
PET
Other 19 resins
PMMA, PMP
PA
PLA
PEN
PVA
PC
Year of Establishment of Individual Resin Specification
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27Private sector in the discussion on positive list legislation
We can find some keywords on the role of private sector in the discussion on positive list legislation in these years.
1. Appreciation on the past effort by private sector. (P.28)
2. The actions of the companies over whole supply-chain are assumed to follow new legislation. (P.29, 30, 31)
3. Private organization will have some role to enforce new legislation. (P.32)
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28
• The government restricts some substances on use according to the applicable standards and specifications (negative list system) etc.
• Industrial associations have introduced their own voluntary management measures.
Ensuring Safety
Ⅰ.Background
Achievement of the management by private sector
Existing regulatory scheme
Excerpt from the Conclusions of the Study Group June 16, 2017
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29Business operators in supply chain based scheme will continue (1)
.
Ⅱ.Desirable scheme
Needs to establish common rules binding both members and non-members of the industrial associations and achieve international consistency in regulatory scheme
Direction of the fundamental Policies
(3)Communication between business operators• Manufacturers of utensils and containers/packaging : Verify that the raw materials are listed in
the positive list (as a part of manufacturing management)• Raw material suppliers : Provide manufacturers of food utensils and containers/packaging with
appropriate information on request• Dealers of food utensils and containers/packaging and food manufacturers : Receive needed
information from manufacturers of utensils and containers/packaging
Specific schemes
Excerpt from the Conclusions of the Study Group June 16, 2017
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30Business operators in supply chain based scheme will continue (2)
General rules
Measures for meeting safety requirements
Schematic diagram of the measures
1. Specific examples to meet safety requirements2. Precautions
§1
§ 2
§ 3
§ 4
• Objectives• Principles• Scope• Definition of terms
• Management of personnel, facilities and equipment • Design of safe products and quality verification• Communication throughout the supply chain• Development of measures to be taken when health hazards occur
PL data of 3 Hygienic AssociationsReference
The Voluntary Management Guideline published on July 10, 2017
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31Experience of industrial associations will be utilized
Ⅱ.Desirable scheme
(2)Risk management methodsSubstances for which the regulatory scheme will be applicable and its risk management methods : These will be continuously examined based on the regulatory practices and use of specific substances in Japan and oversea.
Specific schemes
Excerpt from the Conclusions of the Study Group June 16, 2017
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32Possible mechanism with private organization
3.Change to the existing regulations on food utensils and containers/packaging (implementation of positive list system)
Excerpt from a material of Food Sanitation Committee (June 26, 2017)
Agenda: Draft revision of the food sanitation regulations
(Specific topics) • Viability of implementing any mechanism that accepts only utensils and
containers/packaging that have demonstrated to be safe for those purpose (positive list system) will be studied.* It is anticipated that synthetic resin will be first evaluated for substance type for which the system is
applicable. Specific risk management methods will be further examined from a technical viewpoint* Appropriate arrangements will be made in a manner to accept the existing substances that are
already used if certain requirements are met.* Possible mechanisms should be studied which accept low-risk substances such as
substance from which elution is less than the defined limit provided that their safety is demonstrated to be safe by an independent laboratory according to the regulatory criteria.
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How Should the Private Sector be Involved in the Restrictions?- Opinion of JHOSPA -
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34Forthcoming Revision of Legal Regulation in Japan
1. Achieving safety and hygiene2. Having common recognition on the plastics in the society3. Establishing scientific and rational criterion on materials and
chemical substances
The forthcoming revision may be・・・ Regulation for the violator of Japanese de-facto standards No change for the business operators who follow themThe result of summing up all effects will be “Reinforcement of Regulation”
Why do we accept reinforcement of regulation in this era of the economic growth by deregulation?
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35Wish of JHOSPA
We wish that,• The private sector shall not be just a subject to be regulated, but shall be
the main body designing and complying with restrictions.• Policies must be established integrating legal regulation and voluntary
management.
JHOSPA established voluntary standards and performed issuing certificate to follow the request from MHW. There might be the reason such as the variety of resins, additives, style of use and these combination s well as complexity. It seemed to be difficult to do by the governmental entity such as MHW solely.
On the other hand, although JHOSPA studied foreign scheme and imitated them, JHOSPA as a private organization comprised of private companies could not explain the validity of our voluntary standards from the third party view.
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36
1. A certain range may be entrusted to the private sector.
2. The government shall show the requirements (transparency, equitableness and fairness, technical ability etc.) for an institution.
3. The recognized institution shall implement management with a positive list that protects hygiene.
4. In order to operate such a scheme properly, the government and the private sector shall set up the policy on the management together.
Opinion of JHOSPA (Mar. 1, 2017)
In the review meetings of the Ministry of Health, Labour and Welfare on Mar. 1, 2017, JHOSPA proposed that:
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• GFSI, the typical private initiative in food sector, is expanding its range of activities includingutensils, containers and packaging.
• There are no examples outside of Japan where the private sector has its own PL for achieving hygiene for food utensils, containers, and packaging by controlling migration.
• In the future, the transfer of such a restriction system to the private sector will be essential foreconomic development, globalization and deregulation.
Role of the Private Sector in Hygiene Achievement
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Logistics and economic activities are globalized, and the real aspects of restrictions must be harmonized.
Although JHOSPA is a private association, we are a virtual operator of hygienic regulation in Japan. We would like to cooperate with regulatory authorities in the world and industry organizations who have the desire to establish voluntary rules.
Finally ...The case in Japan must be a model if private sector initiatives in the development of restrictions in this field become generalized.
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• We welcome those who want to achieve hygiene by helping to create and follow our voluntary management rules.
• Please do not join us only for the benefit of your company.
• There are currently 835 JHOSPA members (as of the end of March, 2017). Ten percent of them are foreign companies, and both the number and proportion of foreign companies are increasing.
Join JHOSPA now!
When the Japanese Government pushes forward PL legislation, it will be time for those in the private sector who wish to create new business circumstance to join us.
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• Ensure of transparency in how our voluntary standards are established
• Accountability for society• Globalization
- Promote participation ofoverseas companies
- Cooperate with overseas regulatory agencies
Short-term Action Plan of JHOSPA- Preparation for PL legislation by the Government of Japan -
The JHOSPA shall transform from providing services only for members to providing services for society.
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Working together with synthetic resin utensils, containers and packagingfor 44 years
JHOSPA
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