Regulatory Status for Use in Food Supplements
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Regulatory Status for Use in Food Supplements
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Chondroitin Sulfate Sodium
Japan
This section provides a regulatory assessment for the use of Chondroitin Sulfate Sodium in Food Supplements in Japan.
2.1 Authorized Usage in Food Supplements
Regulatory background on dietary supplement legislation
There is no legal definition for “dietary supplements” or “food supplements” under the current Japanese regulatory system. Dietary supplements are generally considered a subcategory of foods. Of note, under the system for Food with Functional Claims (“FFC”) (See Appendix), foods (as final products) are divided into “fresh foods” and “processed foods”. The “processed foods” category is further divided into “supplement-form processed foods” and “non-supplement-form processed foods” (i.e., conventional foods). According to the FFC guidance document published by the Consumer Affairs Agency (“CAA”) [1], “supplement-form processed foods” are defined as “foods in the form of a tablet, capsule, powder, liquid, etc. that are made from extracts of the natural origin of which constituents are modified from their natural state that are prepared by extraction, purification, chemical reaction, etc. or from chemically-synthesized materials”.
Chondroitin Sulfate Sodium
As described in Section 1.1, chondroitin sulfate sodium is authorized for use as a food additive (humectant) in fish sausage, mayonnaise, and dressing only, and thus its use (as a functional ingredient) in dietary supplements is NOT permitted.
Note: If it is chondroitin sulfate, an extract from animal soft bone that conforms to the Food Sanitation Act (Act No. 233 of 1947) [2], etc., it is allowed for use in dietary supplements with no restriction for use.
2.2 Applicable Specifications (including mandatory quality requirements, if any)
As a Food Additive
For chondroitin sulfate sodium as a food additive, there is a specification established by the MHLW (See section 2.5 - ANNEX - below), and it is included in Japan’s Specifications and Standards of Food Additives (“JSFA”) 9th edition [3]. In order to use the manufacturer’s product in Japan as a food additive, it must conform to this specification. Specific analysis methods and details of regents etc. are found in English on the webpage of the National Institute of Health Sciences [1].
Note: the specification established by the MHLW does not mention the production method. Therefore, the chondroitin sulfate sodium under consideration would be allowed for use if it conforms with the additive specification even if it is produced by microbial fermentation.
2.3 Registration Requirements
As a Food Additive
If the product does not conform to the JSFA specification and/or if the manufacturers wish to use their product in the currently permitted food categories (i.e., fish sausage, mayonnaise, and dressing), they will need to file an application that requests the MHLW to revise the JSFA specification of chondroitin sulfate sodium in the way that the specification covers the product. Similarly, if a manufacturer wishes to use the product in new food categories, they will need to file an application that requests the MHLW to revise the use standards of chondroitin sulfate sodium.
An overview of such a process to request a revision to the MHLW is presented in Figure 1. An overview of data requirements is also presented in Table 2 (See the “revision of standard” column). The timeline from formal receipt of an application by the MHLW until authorization is a minimum of 2 to 3 years. There is a preliminary review step before the MHLW’s formal receipt which requires a minimum of 1 to 2 years.
Figure 1. Process of the Pre-market Evaluation and Authorization of Food Additives [4] |
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Table 2. Overview of Data Requirements for Pre-market Evaluation of Food Additives [4]
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Note 1. When requesting a division of usage standards for a food additive for which an assessment of the effect of the food on health has already been carried out by FSCJ, 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 FSCJ, documents required for designation should be submitted, in principle.
Note 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).
Note 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. |
2.4 References
1. Guideline for the Notification Procedures of Foods with Function Claim (in Japanese)
2. Food Sanitation Act (Act No. 233 of 1947) (in English)
https://www.japaneselawtranslation.go.jp/ja/laws/view/3687
3. About Partial Amendment of the “About the Amendment of the Classification of “Raw Materials Used as Non-pharmaceuticals When Pharmaceutical-like Efficacy Is Not Claimed” under the Food Sanitation Act (Notification by the MHLW Syoku-An-Ki-Hatsu No.0817001 of 17 August 2007)” (Notification by the MHLW Yaku-Shou-Syoku-Ki-Hatsu 0531 No.1 of 31 May 2019)
https://www.mhlw.go.jp/content/11130500/000514735.pdf
4. Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 145 of 1960) (in English)
2.5 Annex
Sodium chondroitin sulfate specifications from Japan’s Specifications and Standards of Food Additives (“JSFA”) 9th edition
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