Japan Amends Food Contact Synthetic Resin Materials and Articles Regulations

Japan publishes Positive List for the substances that can be used in food contact synthetic resin materials and articles.
( | Press Release | 2020-07-02 10:38:11 )
On June 1, 2020, Japan’s latest amendments to its Food Sanitation Act came into effect, establishing a ‘Positive List’ for synthetic resins used in food contact materials and articles. There is now a five-year transition period.

The Japanese Ministry of Health, Labor and Welfare (MHLW) published two notifications relating to food implements, containers, and packaging in April 2020. These were:
• 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 creation of a ‘Positive List’ for synthetic resins in food contact materials and articles. This requires manufacturers to use substances in this list to fabricate food contact materials and articles.

In reality, four lists have been established. These are:

1. Base polymers (plastics) – Table 1 (1)
2. Base polymers (coatings) – Table 1 (2)
3. Monomers that can be polymerized in trace amounts with respect to the base polymer – Table 1 (3)
4. Additives, coatings etc. – Table 2

For 1 and 2, the list contains 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. The third list contains information on the name of each substance and the fourth list contains information on the restriction of use by each synthetic resin category.

Notification No. 195 of 2020 is a supplement to paragraph 3 in Article 18 of the Food Sanitation Act. This now considers 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’s review of the Candidate List for substances to be included on the Positive List had not been completed as of December 23, 2019. This review is expected to be completed by the end of the five-year transition period, with revisions to the Positive List happening accordingly. Stakeholders should be aware the MHLW has already begun reviewing new substances.

Article 50-3 of the Food Sanitation Act requires the MHLW to set the necessary good manufacturing practice (GMP) guidance. This is the Ordinance for Enforcement of the Food Sanitation Law (Article 66-5). GMP requirements are based on safety assurance guidelines.

The amendments came into effect on June 1, 2020. Products that currently don’t conform to the new requirements can continue to be manufactured and sold until May 31, 2025 – the end of the transition period.

SGS Food Contact Material Services
SGS’s technical experts have extensive experience of testing materials and articles in contact with food. They can ensure that your products meet the appropriate regulations for food contact materials and pave the way for compliance. SGS offers the full range of testing, including migration tests, along with expert advice on emerging regulations, compliance issues and documentation review. Learn more about SGS’s Food Contact Material Services. []

SGS SafeGuardS keep you up to date with the latest news and developments in the consumer goods industry. Read the full Japan Publishes Positive List for Food Contact Synthetic Resin Materials and Articles SafeGuardS. []

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For further information contact:

Hingwo Tsang
Global Information and Innovation Manager
Tel:(+852) 2774 7420
LinkedIn: sgs-consumer-goods-&-retail

About SGS
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

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Ben Christie

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