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