Japan has published its Positive List for food contact materials and articles made with synthetic resins. The amendments became effective on June 1, 2020, with a 5-year transitional period.
In April 2020, the Japan Ministry of Health, Labor and Welfare (MHLW) published two notifications on food implements, containers and packaging (food contact materials and articles) to amend the Food Sanitation Act. These notifications are:
- Notification No. 196 of 2020 ‘Partial revision of the standards for foods, additives etc.’
- Notification No. 195 of 2020 ‘Amount specified by the MHLW as an amount that does not harm human health under paragraph 3 in Article 18 of the Food Sanitation Act’
Notification No. 196 of 2020 announces the ‘Positive List’ for synthetic resins in food contact materials and articles by requiring these food contact materials and articles to be manufactured using substances in the Positive List. It creates the following four new Positive Lists:
- Base polymers (plastics, Table 1 (1)) with information on the name of each substance, the types of food permitted (acidic, oily/fatty, milk/daily products, alcoholic and others), maximum temperature use, synthetic resin classification and any restrictions
- Base polymers (coatings, Table 1 (2)) with information on the name of each substance, the types of food permitted (acidic, oily/fatty, milk/dairy products, alcoholic and others), maximum temperature use, synthetic resin classification and any restrictions
- Monomers that can be polymerized in trace amounts with respect to the base polymer (Table 1(3)) with information on the name of each substance
- Additives, coatings etc. (Table 2) with information on the restriction of use by synthetic resin category
Notification No. 195 of 2020 supplements paragraph 3 in Article 18 of the Food Sanitation Act, as amended, by considering a migration value of not more than 0.01 mg/kg to be safe for substances not listed in the Positive List for the manufacture of synthetic resin materials and articles that are not in direct contact with food.
The MHLW continues to review the Candidate List of substances for the Positive List that was not completed as of December 23, 2019. This update of existing substances with additional information will be completed by the end of the five-year transitional period and the Positive List may be revised accordingly. In the meantime, the MHLW has also started to review new substances.
According to Article 50-3 of the Food Sanitation Act, the MHLM will set the necessary good manufacturing practice (GMP) guidance. This is the Ordinance for Enforcement of the Food Sanitation Law (Article 66-5). The GMP requirements are based on safety assurance guidelines in the manufacture etc. of food utensils, containers and packaging.
According to the notifications, these became effective on June 1, 2020. Food contact implements, containers and packaging not complying with the Positive List before June 1, 2020, may continue to be manufactured and sold until May 31, 2025.
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