Japan Regs on Food Contact Materials and Positive List are Explained During CRAC 2019

Japan’s new Food Sanitation Act will be implemented before June 2020 and will have profound implications for regulation of FCMs. The new act will impose a positive list system for specific FCMs; The positive list system applies to food contact plastics only; Current regulations on food contact materials are still applicable; The positive list system is expected to be implemented before June 22, 2020.

On Sep 3, during the 11th Chemical Regulatory Annual Conference (CRAC)^[1] hosted by REACH24H Consulting Group in Xi’an (capital city of Shaanxi Province) , Akira Nakashima from the food marketing department of New Japan Accreditation Association (Shin Nihon Kentai Kyokai) delivered a speech explaining the supervision of food contact materials in Japan.

Current Regs of FCM in Japan

At present, Japan’s government does not supervise the raw materials and additives of food utensils, containers and packaging, but finished food contact products are subject to material test and dissolution test. Test items vary with materials (refer to tables below).

1. Synthetic resin

Categories	Material Test	Dissolution Test
General specifications of synthetic resins (all synthetic resins)	Cadmium, Lead	Heavy metals, KMnO4 Consumption
Phenolic resin PF, Melamine resin MF, Urea resin UF	/	Phenol, Formaldehyde, Evaporation residue
Polyoxymethylene POM	/	Formaldehyde Evaporation residue
Polyvinyl chloride PVC	Dibutyltin (DBT) compound, Tricresyl phosphate (TCP), Vinyl chloride	Evaporation residue
Polyethylene PE, Polypropylene PP	/	Evaporation residue
Polystyrene PS	Volatile substances	Evaporation residue
Polyvinylidene chloride PVDC	Barium, Vinylidene chloride	Evaporation residue
PET	/	Antimony, Germanium, Evaporation residue
PMMA	/	Methyl methacrylate, Evaporation residue
PA	/	Caprolactam, Evaporation residue
PMP	/	Evaporation residue
PC	Bisphenol A, Diphenyl carbonate, Amines	Bisphenol A, Evaporation residue
PVA	/	Evaporation residue
PLA	/	Total lactic acid, Evaporation residue
PEN	/	Germanium, Evaporation residue

2. Rubber

Categories	Material Test	Dissolution Test
Rubber containers and packagings	Cadmium, Lead, 2-mercaptoimidazole	Phenol, Formaldehyde, Zinc, Heavy metals, Evaporation residue

3. Glass/Ceramics/Enamel

Categories	Material Test	Dissolution Test
Glass	/	Cadmium, Lead
Ceramics	/	Cadmium, Lead
Enamel	/	Cadmium, Lead

Revised Food Sanitation Act Introduced Positive List System

The amendment to Food Sanitation Act was published on June 13, 2018 and was the first major revision in 15 years.^[2] It has not entered into effect yet. According to Mr. Nakashima, it will be implemented before June 22, 2020 (the implementation date designated by cabinet office). The New Food Sanitation Act will not change the above specification standards but will introduce additional requirements including:

Positive list system
Hygiene management in the manufacturing process (Good manufacturing practice)
Declaration of Compliance

A screenshot of a social media postDescription automatically generated The positive lists of food contact materials were opened to public feedback in August and that will end on September 7 (refer to previous news Japan Solicits Public Feedback on Food Contact Materials Positive Lists).^[3]These positive lists of polymers and additives only apply to food contact plastics (synthetic resin). Other materials like paper, paperboard, ceramic, glass will still only require compliance with current standards.
A group of people posing for the cameraDescription automatically generated In a side session on food contact materials management, some companies asked questions about the inclusion of a mechanism which would allow both public and industry to influence the expansion of positive lists. In response Mr. Nakashima stated that the Ministry of Health, Labor and Welfare (MHLW) are currently deliberating this issue but as yet no official mechanism or procedures have been proposed.