Overview of Japanese Regulations of Food Utensils, Containers and Packaging

Transcription

1 The 5 th FCM Safety Symposium, Xi an, China Overview of Japanese Regulations of Food Utensils, Containers and Packaging Takuya KONDO Food Safety Standards and Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, Japan (November 2017)

2 Today s Topics Outline of the regulation of Food Utensils, Containers and Packaging (UCP) The Report by the Committee on Regulations on Food UCP The Voluntary Management Guideline for meeting safety requirement on production of food UCP Ministry of Health, Labour and Welfare 2

3 Outline of the regulation of UCP 3

4 About us Outline of the regulations of UCP Ministry of Health, Labour and Welfare of Japan (MHLW) Pharmaceutical Safety and Environmental Health Bureau Policy Planning Division for Environmental Health and Food Safety Food Safety Standards and Evaluation Division Food Inspection and Safety Division International Food Planning Coordinator Office of Port Health Administration Office of Health Policy on Newly Developed Food Office of Agricultural and Veterinary Chemical Residue Office of Import Food Safety Office of Food Poisoning Information Office of HACCP promotion Ministry of Health, Labour and Welfare 4

5 Targets Food Sanitation Act Foods and Food additives Food Utensils, Container and Packaging Toys for young children Detergents for Vegetables/Fruits or Eating Utensils Article 15 Principle of treatment for UCP used in business Article 16 Ban of sales, etc. of toxic or harmful UCP Article 18 Establishment of specifications and standards of UCP Public Notification No.370 (28 Dec 1959) Specifications and Standards for Food and Food Additives, etc. Outline of the regulations of UCP Enacted in Dec 1947 Ministry of Health, Labour and Welfare 5

6 Setting Specifications and Standards Outline of the regulations of UCP Food Safety Commission Ministry of Health, Labour and Welfare Confirmation of contents Party requesting designation, etc. Receiving Implementation of Food Health Impact Evaluation Hearing of opinions Notification Materials on effectiveness and standards Request for risk assessment Confirmation of TDI, etc. Examination of standards and criteria Consultation Pharmaceutical Affairs and Food Sanitation Council (Task force)(examination of draft standards and specifications) Report to WTO, Public Comment Report by the Pharmaceutical Affairs and Food Sanitation Council (Committee) Discussion Response Consumer Affairs Agency Revision of ministerial ordinance and/or public notice Enforcement 6

7 Specifications and Standards Outline of the regulations of UCP Food Sanitation Act Article 18 Compositional Standards for Milk and Milk Products Annex 4. Specifications and Standards of utensils, Containers and Packaging of Milk etc. and Their Materials Sec. 2-1 Normal liquid milk Certified milk Goat milk Skimmed milk Liquid milk recombined Cream PE or PET container and packaging PE-processed paper container and packaging Composite container and packaging Sec. 2-2 Fermented milks Lactic acid drinks Milk drinks Section 1 Food PE, PP, PET or PS container and packaging PE-processed paper container and packaging PE, PP, PS or PET container and packaging with aluminum foil Section 2 Food Additives Sec. 3 Baby formula Plastic-laminated container and packaging Metal can with sealing of PE or PET Specifications and Standards of Food, Food Additives, etc Section 3 Utensils, Containers and Packaging Section 4 Toys Section 5 Detergents A. Specification of utensils, containers and packaging, and their materials B. General test methods of utensils, containers and packaging C. Reagents, test solutions, etc D. Specifications of utensils, containers and packaging and their raw materials by material 1. Glass, ceramic and enameled ware 2. Plastics 3. Rubber 4. Metal can E. Specifications of utensils, containers and packaging by applications F. Standards of manufacture of utensils, containers and packaging 7

8 Specifications by materials Outline of the regulations of UCP material Material test specification Migration test Glass, Ceramic, Enameled ware Plastic Cd Pb General Cd Pb Heavy Metals, KMnO4 Individual * * Metal can General As, Cd, Pb coatings As, Cd, Pb, Phenol, formaldehyde, Evaporation residue, Epichlorohydrin Rubber Cd, Pb 2-ME (only for rubber containing chlorine) Phenol, formaldehyde, Zn, heavy metals, Evaporation residue *:different by a kind of resin 8

9 The Interim Report Committee for Reviewing the Regulations on Food Utensils, Containers and Packaging 9

10 Introduction The Interim Report Current management system in Japan Government (MHLW):Food Sanitation Act Food Sanitation Act (Article 16, 18) Hygienic Associations: Voluntary Standards Voluntary Standards (Positive Lists, Certification System) Regulatory system in Japan/US/EU + Japan US EU Negative List Positive List Positive List 10

11 Outline of the Interim Report (Committee for Reviewing the Regulations on Food Utensils, Containers and Packaging) Responding to Issues and Considerations (1) Chemical substances that shall be subject to risk management Gather and summarize a broad range of information on chemicals including the voluntary standards of the industry. Define the range of necessary information required for scientific evaluation. Review methods to ensure the amount of migration into food of chemical substance from the content in UPC. (2) Information exchange among companies Conclude an agreements on the provision of information on the purchasing of raw materials to properly transmit information on chemical substances used in their products, while protecting trade secret. As a method to transmit the safety information of raw materials, use a method utilizing the certification system of the industry. (3) Proper production management by business operators and ensuring effective implementation Have administrative bodies present guidelines on matters that business operators should work on. Carry out effective testing by developing analysis methods based on the latest international standards. Consider formulating a system to ensure effective implementation for imported products as well. (4) Other Learn the status of PL systems in other countries, methods to handle imported products, facts on UCP, etc. If a PL system is introduced, there will be a necessity to give proper considerations on the protection of trade secret. Additionally, since the system will not allow the use of substances until they are listed, pay attention for the system not to pose a disadvantage in marketing of new products. Immediate Measures It is considered advisable to revise the current specifications and standards and newly establish specifications and standards for synthetic resins in response to technological advancement in UCP, and to promote the measure below in the view of introducing a PL system in the future. Formulate guideline for production management related to production management methods and information transmission for the purpose of further promoting production management by business operators. The formulated guidelines should be made public by the MHLW. It is advisable for the MHLW to compile a list of chemical substances subject to the voluntary standards of the Three Hygienic Associations and attach it to the guidelines as a reference. Collect and summarize domestic and overseas information on chemical substances to be subject to risk management, systems in other countries, information on relevant business operators, etc. Development of simplified methods to determine the amount of migration into food of chemical substances and define the range of data necessary for scientific evaluation. Promote the development of simultaneous analysis methods for commonly used additives and additives of safety concerns. 11

12 The Committee on the Regulation of Food Utensils, Containers and Packaging Major Developments of the Committee August 23, 2016 September 30, 2016 November 1, 2016 December 13, 2016 January 17, 2017 February 8, 2017 March 1, 2017 From March 17 to April 15, 2017 May 25, 2017 Session 1 Explanation of the current situation of UCP in Japan and other countries; Organization of major points at issue Session 2 Hearing from trade organizations and discussions Session 3 Hearing from trade organizations and discussions Session 4 Hearing from trade organizations and discussions Session 5 Hearing from trade organizations and discussions Session 6 Hearing from trade organizations and discussions Session 7 Discussion on the outline of a drafted report Calls for public comments on the drafted report Session 8 Hearing from trade organizations and discussions on the finalized draft report June 16, 2017 Announcement of the final report 12

13 The Committee on the Regulation of Food Utensils, Containers and Packaging Committee Members (in Japanese alphabetical order; Honorifics omitted) Hiroyuki Ito Kazuyuki Omae Hisako Ogura Kazuo Onitake Kazuya Ono Mitsuhiko Shigekura Iwao Nakajima Yuji Nishikawa Executive director, Japan Franchise Association (general incorporated association) Professor emeritus of Keio University Hisako Ogura Policy staff member of SHODANREN (CONSUMERS.JAPAN) (general incorporated association) Policy staff member of SHODANREN (CONSUMERS.JAPAN) (general incorporated association) Head of Unit, Safety Policy Service, Japanese Consumers Co-operative Union Chairman of Senior Technical Committee, Japan Association of Milk Packaging and Machinery (general incorporated association) Executive Director, Japan Hygienic Olefin and Styrene Plastics Association Director Technical Division, Japan Soft Drink Association (general incorporated association) Managing Director, Food Safety Division, Department of Public Health and Medical Services, Saitama Prefectural Government : Chair : Acting chair 13

14 The Committee on the Regulation of Food Utensils, Containers and Packaging Committee Members (in Japanese alphabetical order; Honorifics omitted) Hiroyuki Furuhashi Harumi Noda Masakazu Horie Hidetoshi Matsui Motoh Mutsuga Maki Morita Akemi Yokota General Manager of Quality Assurance Division, Japan Polypropylene Corporation Manager of Chemistry Section, Chemistry Division, Institute of Food Hygiene, Japan Food Hygiene Association(public interest incorporated association) Department of Food Science, Faculty of Home Economics, Otsuma Women s University Manager of Product Assessment Group, Fundamental Technologies Department, Technical Headquarters, Toyo Seikan Co., Ltd. Chief of Third Section, Division of Food Additives, National Institute of Health Sciences Secretary General, FOOD COMMUNICATION COMPASS (general incorporated association) Associate Professor, Graduate School of Social Sciences, Chiba University (Continued) : Chair : Acting chair 14

15 The Report by the Committee on the Regulations on Food Utensils, Containers and Packaging 15

16 16 Background and Basic Concept Outline of the report by the Committee on the regulation of Food UCP Background The safety of food utensils, containers and packaging (UCP) has been secured mainly by regulation by the national government (Negative List System) and the voluntary management by trade organizations. The EU countries and the United States apply the positive list (PL) system targeting only substances authorized based on risk assessment. In light of diversification of products and an increase in imports, Japan has judged that it is necessary to establish a new regulatory system through consistency with the global regulatory trends. Basic concept From the standpoint of necessity for common rules targeting all business operators concerned and consistency with global regulatory trends, the MHLW should introduce a PL system. Basically, the system will ban the use of substances that are not authorized based on risk assessment.

17 Specific frameworks (1) Materials to which the PL system should apply Outline of the report by the Committee on the regulation of Food UCP Synthetic resins should be prioritized first. The MHLW will continue to discuss whether to apply the system to other materials, such as metals and paper considering the necessity and priority. (2) Risk management Substances subject to the PL system and methods for risk management : synthetic resins (The MHLW will continue to review the scope of target substances and methods, considering conditions at home and abroad.) Parts subject to the PL system : Food-contact surfaces In addition to food-contact surfaces, the system should apply to inner layers of multi-layered structures, which do not directly contact with food, if components of the layers are likely to migrate into the food. Risk assessment : The establishment of an assessment scheme that is rational, scientific, and globally consistent is urgently required. Others : The use of substances currently used should continue to be allowed, subject to the fulfillment of certain requirements. Substances including those with significant toxicity (e.g., heavy metals) and impurities should continue to be subject to the current risk management system. 17

18 Specific frameworks (3) Information sharing among business operators Outline of the report by the Committee on the regulation of Food UCP UCP manufacturers Should confirm that the raw materials of the UCP comply with the PL system (as part of manufacturing practice). Raw material manufacturers Should provide UCP manufacturers with information required upon a request from them. UCP distributors and food manufacturers Should be provided with necessary information from the UCP manufacturers. (4) Good manufacturing practice (GMP) The MHLW should establish a system to require UCP manufacturers to apply GMP. (5) Identity information on business operators and supervision/guidance by local governments A notification system should be established to ensure the identity of UCP manufacturers. Supervision and guidance should be provided to the business operators based on information obtained on identity and production management. 18

19 Discussion points 1 Materials to which the Positive List system should apply Introduction of Good Practice Management (GMP) in business operators Appropriate information sharing among business operators A mechanism based on notification to identity of UCP* manufacturers Utilization of a third party organization for smooth designation Discussion points 2 Scope of substances subject to risk management Method of risk management Parts subject to the Positive List system coverage Risk assessment methods Substances that are currently used Control of substances with significant toxicity such as heavy metals Discussion points 3 The technical committee on the Regulation of Food Utensils, Containers and Packaging Measures that make it easier for business operators and consumers who use UCP* to check an item s compliance with the Positive List system Consideration the potential increase in the burden of business operators Risk communication concerning the introduction of the Positive List system Handling of recycled materials Handling of active substances, intelligent substances, and nano substances Integration of the specifications and standards for UCP* stipulated in the Ministerial Ordinance on Milk and Milk products Concerning Compositional Standards with the specifications and standards for other UCP* Sanitation control of Imported products *UCP: Utensils, Container and Packaging

20 The Voluntary Management Guideline for meeting safety requirement on production of food utensils, containers and packaging (published on July 10, 2017) 20

21 The Voluntary Management Guideline for meeting safety requirement on production of food utensils, containers and packaging Outline of the Voluntary Management Guidline 1 General Rules Objectives Principles Scope Definition of terms 2 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 3 Schematic diagram of the measures 4 1.Specific examples to meet safety requirements 2.Precautions 21

22 The Voluntary Management Guideline for meeting safety requirement on production of food utensils, containers and packaging Schematic diagram of the measures Law Materials manufactures Law Materials UCP intermediate manufactures Intermediat e Products UCP manufactures Final Products information information information Food products manufactures Communication throughout the supply chain cooperation Communication throughout the supply chain Management of personnel, facilities and equipment Communication throughout the supply chain Design of safe products and quality verification Development of measures to be taken when health hazards occur Building and Operation of Management system 22

23 Website information Report by the Committee on the Regulations on Food Utensils, Containers and Packaging The Interim Report for Reviewing the Regulations on Containers and Utensils 23

24 Thank you for Listening Ministry of Health, Labour and Welfare 24