The requirements to persons marketing a new substance in the EC are that they submit a notification to the relevant authority in the country of manufacture. The notification has to be accompanied by detailed information and investigation results as specified in an appendix to Directive 92/32 (implemented by Statutory Order 831/93). These should reveal how dangerous the substance is for man and the environment. In practice, such studies cost in the order of DKK 500,000.
The responsible authority can intervene if the notification is incomplete or incorrect. The substance may not be placed on the market until the notifier has received confirmation that the notification is in accordance with the requirements stipulated in the Directive. The notifier has the right to receive this confirmation within 60 days (or 30 days if the amount to be placed on the market does not exceed 1 tonne per year). The authority is responsible for ensuring that the Commission is informed, and the latter informs the other Member States.
Notification in the state of manufacture is valid throughout the EC, i.e. the other Member States cannot require substances to be considered by their own authorities prior to being placed on their market.
The regulations applying under Danish law are those that implement the EC Directive, the responsible authority being the Danish EPA.
Progress as a result of the regulation of new chemical substances is in
accordance with intentions since the new regulations prevent the environment from being
exposed to additional harmful substances. During the period 1981-1994, approx. 1,100 new
substances have been notified throughout the EC and at present approx. 200 are being
notified each year. The costs associated with notification and control thus seem to make
enterprises more reserved about placing new chemical substances on the market. In Denmark,
9 new substances have been notified, and 3 more are on the way. There is nothing to
indicate that notification is purposely moved to other EC countries.