In Japan food contact materials are regulated by national legislation as well as by industry voluntary rules. The 1947 enacted Food Sanitation Act regulates foods, food additives, apparatus and packages/containers and also allows for further specifications. It is supported by the food safety basic law. Further, Notification No.370 by the Ministry of Health and Welfare establishes specifications and standards for foods, food additives and other materials. Apart from regulating food contact materials, the Japanese regulation contains an article which attributes responsibility to manufacturers for harm caused by their substances even if they comply with the legislation (Food Sanitation Law, Chapter 1, Art.16). The legislation also outlines the rules under which migration testing has been carried out in order to ensure that an article will meet the specification. As such, metal cans, glass/ceramic/enamel articles, rubber and polymer articles have material-specific standards and are complemented by specifications on 15 particular resins . It further sets limits for some contaminants, such as lead, antimony and polyvinylchloride containing bis(2-ethylhexyl) phthalate (Food Sanitation Law, Chapter 1, Art.18.104.22.168). Dairy and Dairy based products are subject to specific regulations (Ordinance of Specifications and Standards for Milk and Milk Products, Ministry of Health and Welfare Ordinance No.52), as they are thought to be intended for vulnerable populations such as infants and the elderly.
While Japan does not have a positive list of substances authorized for food contact material, voluntary industry rules include a positive list of food contact materials, including those authorized by Title 21 of the U.S. C.F.R., the European Union additive list, those allowed as direct food additives, and substances listed on national legislation in the UK, Germany, Italy, Holland, Belgium and France, but not from the monomer list of the EU. Under this voluntary rule, information on substances can be submitted which is assessed by the industrial safety association committees. These standards are widely respected and compliance is often required by end-of-chain producers.
1. Mori, Y., Rules on food contact materials and articles in Japan, in Global legislation for Food Packaging Materials, R.V. Rinus Rijk, Editor. 2010, Wiley-VCH: Weinheim. p. 291-319.