in fcm management in japan rights all...

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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Copyright(c) Japan Hygienic Olefin And Styrene Plastics Association All Rights Reserved.

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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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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• 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


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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


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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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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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