Japan's Regulation of Food Additives

Transcription

1 Japan's Regulation of Food Additives July 4, 2016 Daisuke Takeuchi Standards and Evaluation Division Department of Environmental Health and Food Safety Pharmaceutical Safety and Environmental Health Bureau, Japan 1

2 Today s Topics The Scope of Food Additives and Positive List System in Japan Authorization System for Food Additives Program for Expedited Authorization 2

3 What Are Food Additives in Japan? Additives" mean substances that are used by being added, mixed or infiltrated into food or by other methods or - in the process of producing food - for the purpose of processing or preserving food (Article 4 of the Food Sanitation Act) 3

4 What Are Food Additives in Japan? (continued) Food additives include: Enzymes Dietary supplements Flavorings Processing aids (substances not remaining in the finished product) Post-harvest fungicides, as well as What are categorized by the EU as additives, such as preservatives and food colors Food additives are equally treated, regardless of whether they are derived from natural sources (e.g., animals and plants) or they are chemically synthesized. 4

5 Japan s Positive List System for Food Additives Article 10 of the FSA Additives (excluding natural flavouring agents and food used as additives), additive preparations, and foods containing additives shall not be sold; or be produced, imported, processed, used, stored, or displayed for the purpose of marketing, except for cases that the Minister of Health, Labour and Welfare specifies as having no risk to human health by hearing the opinions of the Pharmaceutical Affairs and Food Sanitation Council. Guideline for the designation of food additives and revision of food additive standards (Notice No. 29, 1996) Food additives shall not pose a risk to human health and their use needs to provide benefits to consumers. -Food additives are regulated by the Positive List System -Food Additives are not permitted for use unless proven safe and effective 5

6 Japan s Positive List System for Food Additives (continued) All food additives have been regulated by the FSA (enacted in 1947). Under the Positive List System, only additives designated by the Minister of Health, Labour and Welfare (Minister), as safe to humans, are permitted for use in foods. This system had, however, been applied only to chemically synthesized additives until 1995 when the Food Sanitation Act was amended. By the amendment of the FSA, non-synthetic additives have also been included in the system. Currently, all types of additives, whether synthetic or non-synthetic, are equally subject to the system, with minor exceptions. synthetic non-synthetic 1947 synthetic 1995 Only synthesized additives regulated All types of additives regulated 6

7 Categories for Food Additives Designated Additives Existing food additives Natural flavouring agents Ordinary foods used as food additives Definition Substances that were designated by the Minister based on Article 10 of the FSA Substances that were permitted for use and distribution in Japan at the time of the 1995 revision of the FSA, as exception, without through the designation system, for the reason that they are widely used in Japan and have a long history of human consumption. They are placed on the List of Existing Food Additives. Substances that are derived from natural sources, such as animals and plants, and used for flavouring purposes Substances that are generally provided for eating or drinking as food and also used as food additives No. of substances remark 365 Will be delisted if they have problems with safety or they are no longer in use Ca Ca Exempt from designation as additives 1 as of June 30,

8 Flavoring Agents Flavoring agents are permitted for use only when they are designated by the Minister for flavoring purposes. Currently, about 130 substances and 18 chemical categories are designated. Basically, substances falling under the categories can be freely used. 1 Isothiocyanates* 2 Indoles and Its Derivatives 3 Ethers 4 Esters 5 Ketones 6 Fatty Acids R1-O-R2 R1-COOR2 7 Aliphatic Higher Alcohols O R 1 R 2 R1-COOH R1-NCS 8 Aliphatic Higher Aldehydes* 9 Aliphatic Higher Hydrocarbons* R 1 R 1 R 1 N R 2 R 1 CH 3 OH O 10 Thioethers* 11 Thiols (Thioalcohols)* 12 Terpene Hydrocarbons 13 Phenol Ethers* 14 Phenols* O 15 Furfurals and Its Derivatives* 16 Aromatic Alcohols 17 Aromatic Aldehydes* 18 Lactones* R 1 R1-S-R2, R1-SSS-R2 OH R 1 O O R 2 R 1 O R 1 R 1 R1-SH C H 3 R 1 OH O CH 2 CH3 O Note Substances marked with asterisk exclude those generally recognized as highly toxic. Higher means C6 or higher. 8

9 Specifications and Standards for Food Additives FSA Article 10 Prohibition of sale of unapproved food additives Article 11 Standards and specifications for foods and food additives Specifications and Standards for Foods, Food Additives, etc. (Notification) I. Food II. Food Additives (specifications and standards are established) 9

10 Example of Specifications and Standards Benzoic Acid (preservative) Specifications Content Not less than 99.5% Description White laminar or needle crystals Odorless or slight odor of benzaldehyde Identification A solution of 1 g of the sample in 20 ml of a 1 in 25 solution of sodium hydroxide responds to test (2) for Benzoate Purity (1) Melting point (2) Heavy metals Not more than 10 µg/g as Pb Standards Caviar ( 2.5 g/kg), Margarine ( 1.0g/kg), Nonalcoholic beverages ( 0.60 g/kg), Soy sauce ( 0.60 g/kg), and Syrup ( 0.60 g/kg) When the additive is used in margarine with Sorbic Acid, Calcium Sorbate, or Potassium Sorbate, or a preparation containing one of these additives: The sum of the amount as benzoic acid and the amount as sorbic acid 1.0 g/kg 10

11 Authorization System for Food Additives The Food Safety Commission (FSC) assesses the human health risk of food additives, and the Ministry of Health, Labour and Welfare (MHLW) designates food additives based on the risk assessment. After the substances are proven safe, the use of them are permitted. FSC Risk Assessment MHLW Receive an application Applicant Toxicity Evaluation Chronic toxicity Carcinogenicity Teratogenicity, etc. Hearing Examine documents Request assessment ADI (draft) Seek comments Set the ADI Consumer Affairs Agency (CAA) Notice Recommendation Hearing Response Risk Management Confirm the ADI Review standards Consult Notify the WTO, Seek comments Ministerial Ordinance, Notification (draft) (Food Safety Council Committees )Report Pharmaceutical Affairs and Food Sanitation Council Revise Ordinance & Notification 11

12 The Standard Period Required to Designate Food Additives The standard period is A. One year for risk assessment by the FSC B. One year for legal formalities by the MHLW A. Time from when the MHLW requests the FSC to carry out assessment to when the MHLW is notified of the assessment result by the FSC B. Time from when the MHLW is notified of the assessment result to when the target additive is designated The standard period does not include: Time needed for the applicant to prepare and submit additional documents requested by the FSC or the relevant councils (Commission decision, July 16, 2009 ) (Director of Department of Environmental Health and Food Safety Notice, June 10, 2016) 12

13 Documents Submitted at Application Guidelines for Designation of Food Additives and Revision of Standards for Use of Food Additives (Director-General Notice No. 29, March 22, 1996 ) Purpose: The guidelines are designed to outline the procedures required to apply for the designation of food additives, pursuant to Article 10 of the Food Sanitation Act, and for the establishment of use standards for food additives, pursuant to Article 11. The guidelines detail the documentation submitted for application, such as information on safety evaluation and recommended methods for safety studies required to prepare the documentation. Application form Documents Accompanying documents Overview Documentation References (Quoted materials) 13

14 Overview Documentation Ⅰ.Subject food additive 1.Name and uses 2.Origin or details of development 3.Use status in foreign countries 4.Assessments by national and international organizations 5.Physicochemical properties 6.Use standards (draft) 7.Other Ⅲ.Findings regarding safety 1.Disposition studies 2.Toxicological studies 3.Findings in humans 4.Estimation of daily intake Ⅳ.References Ⅱ.Findings regarding effectiveness 1. Effectiveness as food additive and comparison with other additives of the same use 2. Stability in food 3. Effects on nutritional components in food 14

15 Flow of assessment of food additives FSC Risk managers Hearing of the background and details of assessment requests Deliberation Request for assessment Summarization of deliberations and drafting of assessment reports Call for comments from the public (generally for 30 days) Opinion exchange meetings Consider public opinion/information Finalization of assessment reports Risk managers Notification of assessment results 15

16 FSCJ s policy for Risk Assessment of Food Additives Risk assessment of food additives is performed following Guideline for Assessment of the Effect of Food on Human Health Regarding Food Additives (May 2010) This guideline is available on the FSCJ s website; (Japanese version) Assessment_of_the_Effect_of_Foodon_Human_Healt h_regarding_food_additives.pdf (English version) 16

17 Information Required for FSC Assessments of Food Additives Quoted from Guideline for Assessment of the Effect of Food on Human Health Regarding Food Additives (FSC, May, 2010) (*1). When requesting a division of usage standards for a food additive for which assessment of the effect of the food on health has already been carried out by FSC, the materials required for Revision of standard should be submitted. When requesting a division of usage standards for a food additive for which assessment of the effect of the food on health has not been carried out by FSC, documents required for designation should be submitted, in principle. (*2) Materials marked Required should be submitted whenever applicable. Materials marked with an asterisk (*) should be submitted as necessary (when there is a new finding, for example). (*3) When a combination test for chronic toxicity and carcinogenicity is carried out using one rodent species, a chronic toxicity test and carcinogenicity test on another rodent species can be omitted. 17

18 Program for Expedited Authorization To expedite the designation process, in 2014 the MHLW: - set up a center (FADCC) in the National Institute of Health Sciences to advise applicants on the designation procedure Some contents of FADCC is Japanese only. - released a guidance to show, in an easy-to understand way, how to write documents required for the designation procedure. (next slide) 18

19 Program for Expedited Authorization (continued) The Procedure for Preparing Application Documents for Designation of Food Additives and Revision of Use Standards for Food Additives (Director of Standards and Evaluation Division Notice, September 9, 2014) Purpose Deepen applicants understanding of the designation procedure for food additives Help applicants efficiently prepare application documents Outline The procedure specifically describes how to write the application documents, based on the guidelines published in Director-General Notice No. 29 on March 22, It contains: explanations, points to which attention should be paid, how to confirm relevant information, and examples of description for each item. For the procedure, go to 19

20 Closing Thank You for Listening. 20