The first REACH obligation, pre-registration, has already been completed. It took place from 1 June 2008 to 30 November 2008. Under pre-registration, companies have issued basic information (name of substance and registrant, physiological, toxicological, and eco-toxicological data available) on the substances they want to register.
Manufacturers and importers will create a technical dossier of information on the substances that require registration. In addition, the technical dossier describes the intended use of the substance and provides important recommendations for safe handling and first aid measures.
Manufacturers and importers will create a technical dossier of information on the substances that require registration. In addition, the technical dossier describes the intended use of the substance and provides important recommendations for safe handling and first aid measures (see also Timeline).
If the annual production exceeds 10 tons, manufacturers and importers will have to evaluate additional information on effects and environmental behaviour in an additional substance safety report. This report will explain – based on the substance safety evaluation – which possible risks are associated with the respective substance and how these are to be managed. If manufacturers and importers identify gaps of knowledge in the substance safety report, they may propose an approach of how to fill these gaps. The aim is to generate reliable data, but at the same time to avoid unnecessary tests, especially animal testing. The extent of data to be provided increases for annual production volumes of 100 tons and 1,000 tons respectively. There will not be any additional registration mechanisms beyond these thresholds. New substances (those introduced after 1981) need to be registered before they are placed on the market. Their registration has started on 1 June 2008.
Evaluation by the Authorities
An important instrument of quality assurance is the evaluation. Here, the relevant authorities of the member states will evaluate the registration dossiers (compliance check) and examine substances which cause concern. Furthermore, they will study any proposal for animal testing with great care to limit this practice to an absolute minimum. If suspicious facts are identified, the authorities themselves may propose measures targeted at closing the information gap. Resulting from the evaluation, a testing strategy will be defined and companies will have to put this into practice within a given period of time. The evaluation of the registered information will be carried out for all substances exceeding a production volume of 100 tons per year. The role of companies/the industry in the evaluation is limited; it mainly consists of filling information gaps or commenting on decision drafts of the chemicals agency.
The Authorisation Process
Substances known or expected to be seriously hazardous require authorisation. They are labelled "of special concern" and, under REACH regulation, divided into three groups: Substances that may cause cancer, alter the genetic information, or result in impaired reproduction (carcinogenic, mutagenic and toxic to reproduction: CMRs), are authorised only if the safety of their applications is demonstrated by the industry. Substances that do not degrade naturally, accumulate in organisms, and are generally toxic (persistent, bio-accumulative and toxic: PBTs) and substances that are very persistent and very bio-accumulative (vPvBs) will be identified through further research. The EU Commission will identify at a later stage how such substances should be treated – particularly whether they should be subject to the authorisation procedure.