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Japan has officially released the 370 Notice and Revised List of Normative Standards for Food, Food Additives, etc
Time：
2023-12-22
On November 30, 2023, Japan revised its food contact material inventory system, production management, and information transmission related regulations and standard requirements, which will be implemented from June 1, 2025.
On November 30, 2023, Japan once again revised the regulations and standard requirements related to the food contact material inventory system, production management, and information transmission. In order to facilitate the understanding of regulations and the use of the checklist by relevant parties, a detailed interpretation of the revised content has been provided.
PART1
Overview of Revision Status
Figure 1 Overview of Food Contact Material Revision in Japan on November 30, 2023
PART2
Revision 1
Partial revision of the "Normative Standards for Food, Food Additives, etc."
On November 30th, the Japanese Ministry of Health, Labour and Welfare officially released a partial revision of Chapter 3 "Food Appliances, Containers, and Packaging" of the "Normative Standards for Food, Food Additives, etc." (Notice No. 324 of the Ministry of Health, Labour and Welfare). At the same time, in order to facilitate the understanding and implementation of this revision, and to ensure the compliance of food contact products in the Japanese market after implementation, the Ministry of Health, Labour and Welfare has also issued notices such as "Kenshengfa 1130 No. 4", "Kenshengshijifa 1130 No. 1", and "Kenshengshijifa 1130 No. 4".
（1） Announcement No. 324 of the Ministry of Health, Labour and Welfare
The revised version of Notice No. 324 of the Ministry of Health, Labour and Welfare is consistent with the revised draft solicited from August 4, 2023 to September 3, 2023. It mainly revised Article 8 of Part A of Chapter 3 of Notice 370, "General Specifications for Appliances, Containers, Packaging and Their Raw Materials", and Annex 1 (Main List) Tables 1 and 2. The specific revised management requirements are as follows:
1 Revision of Article 8 of Part A "General Specifications for Appliances, Containers, Packaging and Their Raw Materials":
(1) The raw materials for synthetic resins listed in the substance name column of Table 1 in Annex 1 have no restrictions on the content of the substances they contain.
(2) The substances listed in the substance names column of Appendix 1 and Table 2, when used as raw materials for packaging utensils or containers, shall not exceed the amount specified in the usage restriction column corresponding to the material classification column specified in Appendix 1 and Table 2, unless otherwise specified in the special instructions column of the table. This column corresponds to the substance names listed in Appendix 1 and Table 1.
2 Revision of Tables 1 and 2 in Annex 1 (Main List):
Regarding the positive list of substances allowed to be used in food utensils, containers, and packaging, the revised content is as follows:
(1) Attachment 1 Table 1 Basic Material List
The revised Annex 1 Table 1 Basic Material List has been published, which distinguishes materials into 5 categories and 21 types of polymers based on their characteristics. The polymer usage restrictions (food category, usage temperature, and special items) in the original list have been removed. The specific content of Annex 1 Table 1 is shown in the table below.
Attachment 1 Table 1 Basic Material List
(2) Attachment 1 Table 2 Additive List
Appendix 1 and Table 2 have approved additives numbered 1-827. For the allowed additives, the table lists their serial numbers, substance names, corresponding usage amounts in the classification of 5 types of materials, and provisions for special matters.
（2） Notice No. 4 of Jianshengfa 1130
In response to the announcement No. 324 issued by the Ministry of Health, Labour and Welfare, the Ministry of Health, Labour and Welfare has issued a notice titled "Partial Revision of Normative Standards for Food, Food Additives, etc." (Jian Sheng Fa 1130 No. 4), which revised the Ministry of Health, Labour and Welfare's announcement No. 324 and clarified the management objects of the main list:
The basic materials in Table 1 refer to polymers with a molecular weight of over 1000 and in solid form at room temperature and pressure;
The additives in Table 2 refer to organic low molecular weight substances (including substances with specific functional groups that exhibit specific effects on the substrate and have a molecular weight exceeding 1000) that are intended to change the physical or chemical properties of the substrate and remain in the final product without undergoing chemical reactions.
In addition, the supplementary explanation on the management objects of the regular list in the notice also includes situations where multi-layer utensils, containers, and packaging made of synthetic resin materials for food are/are not within the scope of the regular list management; The requirements for colorants and other related content have been clarified; And it is indicated that the Ministry of Health, Labour and Welfare has specifically issued Notice No. 1130 of the Health and Food Foundation for the relevant regulations on the composition of monomers and other basic materials in Table 1; In response to the supplementary explanation in the special items column of the additive list in Table 2, a notice titled "Jiansheng Shijifa 1130 No. 4" has been specially issued. The specific content of the above two notices can be found in the following text.
（3） Notice No. 1130 No.1 of Jiansheng Food Foundation
This notice is related to the regulations on the composition of monomers and other components of the basic materials in Table 1. It publishes a reference list of monomers and other combinations of basic materials in Table 1 of Annex 1, with a total of 21 attachments, providing a list of necessary monomers, optional substances, and combinations of necessary and non necessary chemical treatments that make up 21 types of basic material polymers; Corresponding usage restrictions have been established for substances that are allowed to be used; And supplementary explanations were provided on the precautions for using reference lists for individual combinations.
（4） Notice No. 1130 No. 4 of Jiansheng Food Foundation
The notice stipulates supplementary explanations for the special items column in Annex 1, Table 2, Additive List, and its specific content is as follows:
(1) The situations specified in the special items column refer to matters related to the use of substances, such as usage temperature, contact with food, material thickness, whether there is direct contact with food, and the sum of usage amounts.
(2) Clarify the food categories involved in the special matters column, and provide examples for situations with special regulations, such as clarifying the following content:
Alcohol: Refers to beverages with an alcohol concentration of 1% or more (volume fraction).
Acidic food: refers to food with a pH value below 4.6 in or on the surface of the food.
Oil and fatty foods: Refers to foods with an oil content of over 20% in or on the surface of the food.
Food containing oils and fats: Refers to food containing oils, fats, and high fat, as well as food containing one or more of these ingredients.
Non solid: Refers to the property of a substance having fluidity. In addition, having fluidity refers to the shape change that can be visually observed after being left standing for several hours to one day.
（5） Implementation date and transition period
The implementation date of the above notice and notice is June 1, 2025.
The transition period is still 5 years, requiring any raw materials or products used for food contact purposes that have been produced, sold, used, or exported to Japan before June 1, 2020, even if the substances used are not on the list, to continue corresponding activities within Japan during the transition period.
（6） Change of information release address
According to changes in relevant administrative requirements in Japan, the information on the regular list will be transferred from the official website of the Ministry of Health, Labour and Welfare to the official website of the Consumer Department for publication after April 1, 2024.
PART3
Revision 2
Revision of Article 18, Item 3 of the Food Hygiene Law, Supplementary Explanation on the Quantity that Will Not Cause Harm to the Human Body
（1） Amendment to Notice No. 6 of Raw Food Development 0501
On April 28, 2020, the Japanese Ministry of Health, Labour and Welfare issued Notice No. 195, which clearly stated in Article 18 (3) of the Food Hygiene Law that "the amount that will not cause harm to human health" is 0.01 mg/kg. On May 1, 2020, the Japanese Ministry of Labor and Welfare issued a supplementary explanation to this announcement, issuing Notice No. 6 of "Raw Food Development 0501". With the partial revision of the "Specification Standards for Food, Food Additives, etc." on November 30, 2023, the Ministry of Labor and Welfare revised Notice No. 6 of "Raw Food Development 0501" to regulate the dissolution amount of substances in food simulants, The dissolution test method should be carried out in accordance with Annex 2 of the Guidelines for Food Health Impact Assessment of Food Utensils, Containers, and Packaging issued by the Japan Food Safety Commission on May 28, 2019; And in order to maintain consistency with Article 8 of Part A of Chapter 3 and the contents of the revised list, the Ministry of Health, Labour and Welfare has also revised the relevant provisions in this notice.
PART4
Revision 3
Revision of Article 66-5 (Responsibility and Obligations of Manufacturers) of the Implementation Rules of the Food Hygiene Law
On November 30th, the Japanese Ministry of Health, Labour and Welfare issued a partial amendment to the Implementation Rules of the Food Hygiene Law (Order No. 149 of the Ministry of Health, Labour and Welfare) in accordance with Article 52 (Responsibilities and Obligations of Producers) of the Food Hygiene Law, which stipulates that "necessary public health management should be taken for food utensils, containers and packaging, and the cleanliness inside and outside of equipment should be maintained, as well as other general hygiene management requirements", The official implementation date of this revision is June 1, 2025. This revision mainly revised the content of Article 66-5 of the Implementation Rules of the Food Hygiene Law, which is reflected in the addition, deletion, and revision of some articles. For example, the revised version stipulates the obligations of manufacturers of utensils, containers, and packaging, and should transmit relevant information about utensils or container packaging as much as possible to prevent food hygiene hazards; Establish methods for handling food hygiene accidents; Management standards should be established for the production of synthetic resin instruments, containers, and packaging, and relevant written record documents should be written and saved.
PART5
Prompt
The 370 notice and revised list issued this time have been officially approved and will be implemented from June 1, 2025. Relevant production and export enterprises are requested to timely verify the substances used in their products, confirm whether they meet the requirements of the list, including whether the basic materials and additives used are listed on the list, whether they meet the requirements of the use quantity and special use in the list, and so on. In addition, the Ministry of Health, Labour and Welfare has also made regulations on the obligations of producers. Relevant parties are requested to pay attention to and respond promptly.
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