Registration, proposed, requirements

U.S. Environmental Protection Agency, Pesticide Registration Proposed Data Requirements, Federal Register, Vol 47, No. 227, November 24, 1982. 

U.S. Environmental Protection Agency Pesticides Registration Proposed Data Requirements, 24, Nov. 1982, 40 CFR Part 158, Federal Register 1982, (227) 53182. 

Environmental Protection Agency (1982) Pesticides registrations proposed data requirements. Sec. 158.135 toxicology data requirements. Federal Regulations 47 53192 Feldman RJ, Maibach HI (1967) Regional variation in percutaneous penetration of [ " C] cortisone in man. J Invest Dermatol 48 181-183... 

In what is being called the most far-reaching overhaul of European Union environmental policy ever, the European Commission released a draft policy proposal on May 7 that, if enacted, would require virtually all manufacturers of chemicals to provide risk assessments and other information regarding products they sell or ship into the EU. Chemicals would also have to be registered with the EC and many downstream users of products that contain chemical entities would have to file paperwork as well. The Registration, Evaluation and Authorisation of Chemicals, or REACH, proposal would apply to approximately 30,000 new and existing chemicals, and test data would have to be developed on some 5000 specific chemical entities, many of which have been commonly used for decades. EUROPEAN COMMISSION... 

Among the requirements for registration of pesticides in the United States, the 1978 guidelines proposed by the U.S. Environmental Protection Agency (3) list general metabolism studies "in at least one mammalian species, preferably the laboratory rat. .." Although similar tests have been conducted on other terrestrial species with increasing frequency, the small rodents have remained the principal source of metabolism data from intact animals. 

Evaluation is undertaken by the ECHA (see below) to evaluate testing proposals made by industry or to check compliance with the registration requirements. The ECHA will also coordinate substance evaluation by the authorities to investigate chemicals with perceived risks. This assessment may be used later to prepare proposals for restrictions or authorization. Substances with properties of very high concern will be made subject to authorization the ECHA will publish a list containing such candidate substances. Applicants will have to demonstrate that risks associated with uses of these substances are adequately controlled or that the socioeconomic benefits of their use outweigh the risks and there are no suitable alternative substitute substances or technologies. 

Foreign establishments are not currently required to register with the FDA. On May 14,1999 FDA published a proposed rule to require registration of foreign establishments (64 FR 26330). Until the time registration of foreign establishments is required, same and different manufacturing sites mean ... 

Increased production levels require additional toxicology and ecotoxicology data to ensure that prolonged exposure effects are understood.10 Today, the ELINCS system is being progressed under European proposals labeled REACH—Registration, Evaluation and Authorization of Chemicals. 

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