The role of private sector in FCM management in Japan FCS All Rights Reserved

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1 The 5 th Food Contact Material Safety Symposium, Xi an The role of private sector in FCM management in Japan November M.Shigekura, JHOSPA

2 AGENDA 1 Current Legal Regulatory Scheme in Japan 2 Voluntary 3 4 Management Rules of JHOSPA Relationship between National Legal Regulations and Private Voluntary Management Rules How Should the Private Sector be Involved in the Restrictions? - Opinion of JHOSPA - This presentation contains some tentative translated excerpt of official documents prepared by lecturer. Please check genuine Japanese version before legal action.

3 Current Legal Regulatory Scheme in Japan

4 Food Sanitation Act 4 Chapter I Chapter II Chapter III Chapter IV Chapter V Chapter VI Chapter VII Chapter VIII Chapter IX Chapter X Chapter XI General Provisions Article 1, 3 Food and Additives 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 Labeling and Advertising Japanese Standards of Food Additives Guidelines and Plans for Monitoring and Guidance Inspections Article 26, 27, 28 Registered Conformity Assessment Bodies Business Article 55 Miscellaneous Provisions Article 58 Penal Provisions Article 72,73 Supplementary Provisions

5 Specifications and Standards 5 Ministerial Ordinance on Milk and Milk products Concerning Compositional Standards, etc. Food Sanitation Act Article18 Notification of Specifications and Standards of Food, Food Additives, etc.

6 Specifications and Standards 6 Specifications and Standards of Food, Food Additives, etc. MHW Notification No.370, (Dec. 28, 1959) Section 3, Utensils, Containers and Packaging A. General Specifications 8 articles D. Specifications by Material 2. Plastics 3 articles for general and 14 articles for individual resins E. Specifications by applications 5 articles F. Standards of manufacture 5 articles A4size 55pages, 910Kb in PDF file

7 Specifications by Material 7 Plastics material General Individual Cd, Pb Catalyst etc. Material test specification Elution test Heavy Metals, Potassium Permanganate Consumption Monomer, Evaporation Residue Material test : measuring the contents of components in the sample Elution 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.

8 Specifications by Individual Resins 8 Resins 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

9 Legal Regulatory Scheme in Japan is purely Negative? 9 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.

10 Voluntary Management Rules of JHOSPA

11 Restriction Scheme in Japan 11 Legal Regulations Japanese Government (MHLW), Local Governments Prohibition provisions Specifications and standards Monitoring and supervision Hybrid Voluntary Management Rules Industry Organizations (3 Hygienic Associations) Voluntary standards (Positive lists, hygienic test methods) Confirmation certification service

12 Features of Voluntary Management Rules of JHOSPA (Voluntary Standards + Confirmation Certification Service) - (1) 12 Listing to the positive list (PL) Removal from the PL(In case of safety problems etc.) Fast About 2 months Within 1month Issuance of Confirmation Certificate About 1month

13 Features of Voluntary Management Rules of JHOSPA (Voluntary Standards + Confirmation Certification Service) - (2) 13 Easy to use and follow on site 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.

14 Background to the Introduction of Voluntary Management Rules by JHOSPA 14 Request from the MHW Establishment of the association Adoption of the FDA method for the development of private voluntary standards 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. Includes the entire supply chain, as well as the food industry. Second hygienic association after the Japan Hygienic PVC Association (JHPA). At this time, the FDA was the only organization worldwide to apply additive restrictions. Certification and PL mark indication rules were also established.

15 Covered Resins by Voluntary Management Rules of JHOSPA 15 Sept Request for cooperation from MHW Polyethylene (PE) Polypropylene (PP) Polystyrene (PS) Sept Establishment of JHOSPA AS resin (AS) Polymethylmethacrylat e (PMMA) Polybutene-1 (PB-1) Polyacetal (POM) Polybutylene terephthalate (PBT) Polyhydroxybenzoic acid (HBP) Polyester carbonate (PPC) Ethylene/2-norbornene polymer (E/NB) ABS resin (ABS) Polymethylpentene (PMP) Polyethylene terephthalate (PET) Polyphenylene ether (PPE) Methylmethacrylatestyrene resin (MS) Polyetherimide (PEI) Ethylene/tetracyclodo decene polymer (E/TD) Butadiene resin (BDR) Polycarbonate (PC) Polyacrylonitrile (PAN) Polyarylsulfone (PASF) Polycyclohexylenedime thylene terephthalate (PCT) Polylactic acid (PLA) Nylon resin (PA) Polyvinylalcohol (PVA) Fluorocarbon resin (FR) Polyarylate (PAR) Polyethylene naphthalate (PEN) Polybutylenesuccinate (PBS)

16 Positive List of JHOSPA 16 Number of substances on our PL: 1,166 Category Type Number of substances Synthetic resin Base polymer 30 Additive and embrocation Monomer 139 Catalyzer/adjuster 83 Stabilizer 148 Surfactant 81 Lubricant 88 Filler 71 Foaming agent 9 Polymer additive 132 As of March 2016 Radical initiator 39 Other additives 95 Colorant 251 Total 1,166

17 Listing to our Positive List 17 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 listed to 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.

18 Listing to our Positive List 18 In terms of the actual examining work for listing, the major parts are 1) Expansion of the listed content 2) Addition of target base polymers 3) Description of the variety of substances which can be handled in the same way. When new regulations are enforced, or any suspected safety information is obtained, additional limitations will be implemented or the listing will be removed. イメージ

19 Conditions for Listng to our Positive List Almost no elution or elution is too small to affect human health. It is not judged to be carcinogenic. It has technical utility as an additive. The listing methodology which utilizes elution properties and accepts rational judgment is common worldwide.

20 Tests Used for PL Judgments in JHOSPA 20 Test Condition Test Purpose Toxicity Test Elution 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 40 C x 10 d 60 C x 60 min 90 C x 30 min 110 C x 10 min (Boiling point x 90 min) Ames test Chromosomal abnormality test or Mouse lymphoma TK test The test condition and the pseudo-food solvent shall be selected according to the conditions of intended use. 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) Screening of presence or absence of carcinogenicity (Only non-carcinogenic substances should be accepted) Calculation of estimated daily intake (EDI)

21 Structure of the JHOSPA Positive List 21 Description etc. of Positive List Management Method Description 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 Appendix Additive name, Additive amount limitation etc. 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.

22 JHOSPA Confirmation Certification Service 22 Our certification means that the JHOSPA has confirmed that the food utensils/product, containers and packaging, and their raw materials 1) conform to our voluntary standards and 2) pass the hygienic test. Number of confirmation certification registrations 13,399 Number of issued certificates 5,000 per year As of March 31, 2017 About

23 JHOSPA Voluntary Management Scheme is purely Positive? 23 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

24 Relationship between National Legal Regulations and Private Voluntary Management Rules

25 Relationship between Legal Regulations and Voluntary Management Rules 25 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. Mutually complementary Advantage of Voluntary Management Rules Fast development Realistic for businesses Facilitation on maintenance and development of rules by participant s Incentives

26 Collaboration between 2 schemes 26 Year of Establishment of Individual Resin Specification PE, PP, PS PMMA, PMP PET PA PC PVA PEN PLA Other 19 resins Voluntary Standards Legal Notification Not established yet

27 Private sector in the discussion on positive list legislation 27 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)

28 Achievement of the management by private sector 28 Ⅰ.Background Existing regulatory scheme 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 Excerpt from the Conclusions of the Study Group June 16, 2017

29 Business operators in supply chain based scheme will continue (1) Ⅱ.Desirable scheme Direction of the fundamental Policies 29. Needs to establish common rules binding both members and non-members of the industrial associations and achieve international consistency in regulatory scheme Specific schemes (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 Excerpt from the Conclusions of the Study Group June 16, 2017

30 Business operators in supply chain based scheme will continue (2) General rules Objectives Principles Scope Definition of terms Measures for meeting safety requirements 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 Schematic diagram of the measures 1. Specific examples to meet safety requirements 2. Precautions Reference PL data of 3 Hygienic Associations The Voluntary Management Guideline published on July 10, 2017

31 Experience of industrial associations will be utilized 31 Ⅱ.Desirable scheme Specific schemes (2)Risk management methods Substances 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. Excerpt from the Conclusions of the Study Group June 16, 2017

32 Possible mechanism with private organization 32 Agenda: Draft revision of the food sanitation regulations 3.Change to the existing regulations on food utensils and containers/packaging (implementation of positive list system) (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. Excerpt from a material of Food Sanitation Committee (June 26, 2017)

33 How Should the Private Sector be Involved in the Restrictions? - Opinion of JHOSPA -

34 Forthcoming Revision of Legal Regulation in Japan 34 The forthcoming revision may be Regulation for the violator of Japanese de-facto standards No change for the business operators who follow them The 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? 1. Achieving safety and hygiene 2. Having common recognition on the plastics in the society 3. Establishing scientific and rational criterion on materials and chemical substances

35 Wish of JHOSPA 35 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. 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.

36 Opinion of JHOSPA (Mar. 1, 2017) 36 In the review meetings of the Ministry of Health, Labour and Welfare on Mar. 1, 2017, JHOSPA proposed that: 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.

37 Role of the Private Sector in Hygiene Achievement 37 GFSI, the typical private initiative in food sector, is expanding its range of activities including utensils, 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 for economic development, globalization and deregulation.

38 Finally... The case in Japan must be a model if private sector initiatives in the development of restrictions in this field become generalized. 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. 38

39 Join JHOSPA now! 39 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. 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.

40 Short-term Action Plan of JHOSPA - Preparation for PL legislation by the Government of Japan - 40 The JHOSPA shall transform from providing services only for members to providing services for society. Ensure of transparency in how our voluntary standards are established Accountability for society Globalization - Promote participation of overseas companies - Cooperate with overseas regulatory agencies

41 JHOSPA Working together with synthetic resin utensils, containers and packaging for 44 years