Japanese regulations

The approved color additives appear on positive lists issued by the Food and Drug Administration in the US, the EU, and Japan, but the colorants permitted in each market vary considerably. US and EU regulatory organizations provide provisional and permanent lists of approved color additives. The permanently listed additives are considered safe for use in cosmetic and toiletry products by the regulatory bodies. Provisionally listed color additives are those on which some safety studies are still to be undertaken or their test results are under review. The Japanese regulations include only a permanent list of color additives. 

In 2006 the material was used for the first commercial launch of mobile phones in lapan with a largely bioplastic case. 75% of the surface of the phone is bioplastic with only the screen and keypads made from conventional materials. The product has a good surface feel making it attractive to consumers, and meets all Japanese regulations for green purchasing and green electronic devices. 

A. Japanese regulations for labeling of food allergenic ingredients... 

According to Japanese regulations, the arsenic standard for soil waters is lOpgl-1 and the soils of paddy fields must not contain more than 15 mg kg-1 of arsenic (http //www.env.go.jp/en/water/soil/sp.html). 

For instance, iron oxides are well known for being some of the most globally accepted colors. They are approved for use in drugs in most countries in the world. However, there are significant differences in the specifications for the various iron oxides listed in U.S. European, and Japanese regulations which mean that only certain iron oxides available in the marketplace can meet all of these requirements. In most cases, these grades must be subjected to many tests to provide assurance of compliance, which impacts the costs of these grades. 

Neither version of this dye is currently approved in Japan for use in drugs because of a lack of precedent. It would probably be possible to obtain approval in Japan if a manufacturer included one of these colorants in a new drug application and provided adequate safety data to convince Japanese regulators that the colorant is safe. However, in practice, most companies avoid using colorants that lack a precedent of previous use in Japan because this will usually delay drug approval. 

The chronological lists of Japanese regulations are described below ... 

In order to clarify the following sections, some regulations have been artificially separated. For Western people not familiar with Japanese regulations, these rules, delivered through hundreds of notifications from the Pharmaceutical Affairs Bureau, are a huge maze. We have tried to simplify this review, and we apologize for the lack of precision consequently induced. 

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