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On Apr. 28, 2020, MHLW issued the announcement No. 195[1] and No. 196[2] detailing the food contact materials regulation updates in Japan. Additionally, the No. 196 announcement states that the revision to the following regulations will come to force on Jun. 1st, 2020, which means that the positive list system will be effective at the same time
l Food Sanitation Act (2018. No.46);
l Food Sanitation Act article 18 (1) (No. 195);
l Standards and criteria for food and food additives, etc. (No. 370)
The major revisions specified in these two announcements are listed below:
1. The requirements of migration amount
According to No. 195 announcement, the amount of substances migrated from food contact materials/articles to food cannot exceed 0.01 mg/kg.
2. The positive list
The latest “Standards for Food and Additives (No. 370)” outlines how enterprises can utilize the positive lists during compliance review. It clarifies that colorants are excluded from the application scope. Polymers in Appendix 1 (2) are only used in coatings. Such revisions apply to the following lists:
The lists that have been updated this time | ||
Base polymers of plastics | ||
Base polymers of coatings etc. (coatings) | ||
Minor monomers can be used for polymerization of base polymers | ||
Positive list of additives | Food contact additives, coating agents etc. | Appendix 2[6] |
MHLW also released the directory of substances awaiting safety evaluation which are excluded from the current positive list, including those submitted by industry stakeholders [7]. It is said that the competent authority will accept the application of supplemented substances and update the positive list after they go through the safety evaluation.
Click here ( [table 1] & [table 2]) for the latest FCM positive list (containing both English & Japanese name and corresponding CNS No.)
3. The grace period for the policy implementation
The implementation of the positive list system is subject to a 5-year grace period starting from Jun. 1, 2020. That is, enterprises can still sell food contact materials and products that comply with the old regulations until May. 31, 2025
However, MHLW emphasized that during the grace period, enterprises should actively implement the new regulations and comply with the positive list. In addition, it is necessary to deliver the compliance information throughout the supply chain and corresponding requirements are listed below (according to Food Sanitation Law Amendment Law-Government Provincial Order):
l Information should be delivered upstream and downstream in the supply chain;
l The information passed does not necessarily disclose the specific information of the substance, but should explain the compliance information of the product;
l The information delivered include contracts with enterprises, quality assurance certificates, industry association confirmation certificates, and any compliance certificates that can indicate compliance with regulations.
Earlier in August 2019, Japan MHLW released official consultation drafts of positive lists of additives and polymers used in food contact materials. You can read ChemLinked news for more details.
