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Is Mutual Recognition Applicable to Japan and the EU and US With Regards to Food-Contact Materials?

June 10, 2008
Question 

I am the Engineering Manager for a company specializing in food equipment design. Is there mutual recognition between Japan and the European Community and the USA in relation to conformity of materials intended to come into contact with foodstuffs? For example, does Japan recognize FDA or NSF approval for specific materials?

Answer 

While there is no formal reciprocity established between Japan and the United States regarding the regulation and approval of food contact materials, Japan generally looks to the United States in cases where there are no current Japanese safety standards in place. FDA or European Union (EU) approval of a substance in food contact applications is regarded as adequate assurance that the substance complies with the safety and suitability provisions of Japanese law. (For more information, please see a packaginglaw.com article on food packaging laws in Japan).

Japan's regulatory framework for food packaging and food contact materials is set forth under Chapter 3, Article 16 of the Food Sanitation Law, which prohibits the sale, manufacture, or import with intent to sell of any package that is toxic, or that may have a harmful effect on food or human health through contact. Currently, Japan has general specifications that apply to all packaging materials, as well as material-specific standards for several substances.

Regulation of food contact materials in Japan is also guided by industry standards, which sometimes reference comparable FDA food additive regulations. Note that industry standards are voluntary, unlike the mandatory specifications established by the Japanese government. While it is not required for companies to comply with industry-developed standards in order to participate in the Japanese food-contact materials market, the standards are widely regarded throughout the Japanese market. The Japan Hygienic Olefin and Styrene Plastics Association (JHOSPA), for example, produces a "positive" list of additives that are appropriate for use in the manufacture of plastic materials for food-contact applications. Companies wishing to add a substance to this list must show that their substance meets one of three criteria. One criterion is a showing that the substance has been cleared for food-contact use in the United States, the UK, Germany, the Netherlands, France, Italy, Denmark or Belgium.

NSF International's Food Equipment Program has established materials requirements specifying that all materials which contact, or potentially will contact, food must not contribute contaminates of toxicological significance to the food (for more information, please click here). However, unlike the FDA standards, compliance with these standards is voluntary, and it is unclear whether Japan recognizes U.S. industry standards.