Comparison of Regulatory Requirements for the Notification of New Chemical Substances in the European Union, the USA and Japan
In accordance with the European Council Directive 92/32/EEC, a full dossier is required for new chemical substances if the tonnage marketed exceeds one tonne per year. For lower tonnage a reduced dossier is sufficient. In the USA, a pre-manufacture notice (PMN) comparable with the European reduced dossier must be sent to the US Environmental Protection Agency. The authorities may also request additional information. Notification of a new chemical substance in Japan is covered by the Chemical Substances Control Law, and a similar dossier is required. European reduced dossier costs are comparable with notification costs (excluding supplementary information if requested) in the USA and Japan. If the amount of the substance placed in the market exceeds 100kg per year, the costs of notification in the EU will be significantly higher than in the US or Japan.
Bibliographic Reference: EUR 18119 EN (1998) 160pp.
Availability: Available from CCR Ispra - Servizio Pubblicazioni
Record Number: 199910466 / Last updated on: 1999-03-19
Original language: en
Available languages: en