Registration
In three stages, based on two criteria, the safety evaluation and registration take place:
Registration deadlines
Quantity of the annually imported or produced materials:
- 1000 tons/a, CMR 1 + 2 class and R 50-53 > 100t/a untill 01.12.2010
- 100 - 1000 tons/a untill 01.06.2013
- 1 - 100 tons/a untill 01.06.2018
CMR materials are treated in detail under authorisation.
An unbureaucratic registration process should be possible by the following measures:
Group registrations
The principle "one substance - one registration" (OSOR) forces manufactures into a consortia to exchange their test results in order to make one registration only. Exceptions of this rule can be granted to manufacturers, who can prove that a disclosure would hurt their interest or intellectual properties.
Quantities from 1 to 10 tons
Simplified registration for materials imported or manufactured in these small quantities, as these quantities were excluded from complete health and safety tests, in order to reduce the costs of the enterprises. An examination clause will decide seven years after the acceptance of the package whether controls must be intensified.
Exception applies only to materials, which are harmless to the human health and the environment.
Quantities from 10 to 100 tons:
Manufacturers can avoid the chemical risk assement evaluation, if they can prove that health risks caused by materials are sufficiently supervised.
The data request for registration depends on the production/import quantity:
- 1-10 t/a: Annex VII, tech. Dossier
- 10-100 t/a: Annex VII, VIII, tech. Dossier and material safety report
- 100-1000 t/a:Annex VII IX, tech. Dossier and material safety report
- 1000 t/a: Annex VII x, tech. Dossier and material safety report