The draft regulation, a copy of which was obtained by ENDS Europe, sets out the different fee exemptions, discounts and payment modalities for authorising chemical substances for sale on the EU market. The Helsinki-based European Chemicals Agency will collect all fees, distributing a set amount to the competent authorities in EU member states under certain conditions.
The annex of the draft provides the following fee schedule for authorising substances in the range of:
- 1-10 tonnes: €1600
- 10-100 tonnes: €4300
- 100-1000 tonnes: €11500
- above 1000 tonnes: €31000
Authorising high-risk chemicals is more expensive, with the price tag set at €50,000 for initial authorisations and renewals.
Fees for submissions by more than one company (joint submissions) are reduced, as are fees for small and medium-sized enterprises (SMEs). Updates or changes to exisiting registrations are governed by a separate fee schedule contained in the annex.
FECC, the European Association of Chemical Distributors, says the fees are elevated and that the industry was not sufficiently consulted by the Commission, according to ENDS Europe.
The Commission has until 1 June 2008 to finalise its regulation, which will be adopted into law through a special committee procedure as laid out in article 133 of the REACH Regulation.
A separate annex on the criteria for exempting certain substances from authorisation under REACH has also been released by the Commission, with a decision on a list of exempt substances expected in 2008.
