Registration requirement for substances and mixtures

The REACH regulation follows the principle "No Data, No Market". This means that all manufacturers and importers of substances or mixtures are obliged to register them if the quantities exceed one tonne per year. There are various exceptions to the registration obligation under REACH, such as intermediates or polymers. As soon as new knowledge about a substance is available, its dossier has to be amended. All registrants of a substance are jointly responsible for this. This measure aims to ensure the prevention of hazards and the implementation of necessary protective measures.

Approval procedure

All substances that are listed in Annex XIV of the REACH regulation and for which the so-called “sunset date” (expiry date) specified therein has been exceeded are subject to approval. In order to be included in Annex XIV of the REACH regulation, the substances must first be identified as being of “very high concern”. Then they are added to the candidate list. In the next step, the substances from the candidate list are evaluated by the chemicals agency ECHA and a committee consisting of the EU member states according to a precisely defined procedure. Finally, they are included in Annex XIV of the REACH regulation.

General substance restrictions according to REACH

A restriction under REACH means that a substance is no longer permitted for use or for inclusion in an product or mixture. These restrictions are listed in the REACH regulation in Annex XVII. Depending on the type of restriction, all actors in the supply chain, i.e. manufacturers, importers, retailers or distributors of substances, mixtures and products, but also downstream users, may be affected by the implementation.

In the publicly avialable Registry of Intentions, all interested parties can view the substances for which there is an intention to submit a restriction dossier concerning the restriction on the manufacture, placing on the market or use of a substance. Qualisys monitors these and other preliminary stages before the actual restrictions come into force and makes them available to you as part of our Substances Information Service.