Evaluation

REACH distinguishes two types of evaluation: dossier evaluation and substance evaluation. Dossiers are the documents handed in by companies for registration. In a first step they are examined with regard to completeness without checking in detail their content. This examination is done automatically and the company is informed whether any information is missing and has to be handed in later.

The examination of the registration documents with regard to their content is also called dossier evaluation. The agency will check the filed data, which have been gathered from toxicological and eco-toxicological studies, with regard to their plausibility and correctness. In case of any doubts the agency will inform the company in question and ask for clarification, correction or completion of the information.

If, according to REACH, toxicological or eco-toxicological studies at vertebrates have to be carried out for substances which are produced or imported in quantities of ≥ 100 t per year in order to evaluate for example the teratogenic properties of a substance, and if this information cannot be obtained by other tests, it is not allowed to just carry out these studies. In fact, they have to be communicated to the agency as proposal. The agency's toxicologists will then decide whether the proposed studies at vertebrates really have to be carried out or whether they can be abandoned. REACH calls this evaluation also dossier evaluation.

In the course of time the agency, in cooperation with the responsible authorities of the EU member states, will establish a list with especially hazardous substances which will be published on its homepage. Besides the hazardous properties of the substances also the produced or imported quantities as well as the fact how and where the substances are applied will be considered. Even a "harmless" substance might cause concern if it is used in very large quantities in a very big area by many people, e.g. in washing agents.

To guarantee that only hazardous substances will appear on the list, the agency intends to adopt guidelines which stipulate under which circumstances a substances can be put on the list. The responsible authorities of the EU member states select substances from this list for which additional information from the producing or importing companies is required. Target of this additional information is an improved evaluation of the risk resulting from this substance. The substance evaluation can lead to the fact that the public authorities decide that the substance in question must be subjected to the authorisation and limitation procedures of REACH.