The REACH Regulation
Registration, evaluation, authorisation and restriction of chemicals.
REACH stands for the registration, evaluation, authorisation and restriction of chemicals. The procedure serves to standardise chemicals legislation across Europe and improves the state of knowledge regarding hazards and risks that can arise from chemicals. A variety of REACH procedures exist, and we describe these in greater detail here.
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What does registration mean for you?
With the REACH Regulation (EC) No 1907/2006, which entered into force in 2007, the obligation to register is placed on the manufacturers and importers. They are required to register all substances or mixtures of substances that exceed a quantity of one tonne per year at a company.
The general principle is, "No data, no market". For you, this means that you are not permitted to manufacture or import a substance that has not been (pre-)registered or to purchase such a substance in the EU.
The registration deadlines were spread over a period of 11 years and established on a tonnage basis. The last registration period ends on 1 June 2018. By this time, all substances must be registered that are manufactured or imported at a rate of more than 1 tonne per annum per company.
Various exemptions apply to the registration of substances, e.g. for certain recycling products, intermediates, polymers or medicinal products.
What does evaluation mean?
Two different evaluation procedures are enshrined in the REACH Regulation: the dossier evaluation and the substance evaluation.
Under this procedure, the European Chemicals Agency (ECHA) evaluates the content of submitted registration dossiers. The ECHA checks whether all of the requirements stipulated by REACH are met in a so-called compliance check (CCH). There is another form of dossier evaluation known as a testing proposal examination (TPE). A registrant must submit a testing proposal of this kind if, according to REACH, the data in their dossier is not complete.
Under this procedure, the individual European Member States evaluate all of the available data relating to a substance. They check whether the data is sufficient to identify or rule out a risk arising from the substance.
If the available data is insufficient, the evaluating Member State prepares a draft decision and requests the missing information. If the available data is sufficient, a conclusion is issued in relation to the evaluation and follow-up measures.
Both procedures also incorporate the registrants and ask them to comment accordingly.
Does the dossier or substance evaluation apply to you as a registrant? Or would you like to know more about the individual procedures? If so, please follow the link below to access the website of the REACH-CLP-Biozid Helpdesk.
What is the significance of the candidate lists and Annex XIV?
Within the framework of REACH, all relevant substances of very high concern (SVHCs) are to be identified and added to the candidate list by 2020. You are allowed to continue manufacturing, processing or using substances on the candidate list or to continue placing such substances on the market.
At irregular intervals, but every two years at the latest, selected substances from the candidate list are prioritised and added to Annex XIV. After a transitional period, these substances must no longer be circulated for use or used without authorisation, except in the case of individual exemptions.
Users, importers or manufacturers can apply to the ECHA for an authorisation for a specific use. The European Commission reaches a decision on the respective application for an authorisation with the participation of the Member States - and specifically based on the opinions of the Committees for Risk Assessment and Socio-Economic Analysis.
A detailed description of the procedure, and of the conditions under which an authorisation may be issued, can be found by following the link below.
When is a substance restricted under REACH?
A restriction under REACH means that a substance is no longer permitted for a use or for inclusion in an article or mixture. These restrictions are set out in Annex XVII to the REACH Regulation and apply, for example, to lead and its compounds: "Lead and its compounds shall not be placed on the market or used in any individual part of jewellery articles if the concentration of lead (expressed as metal) in such a part is equal to or greater than 0.05 % by weight" (REACH Regulation, Annex XVII, Entry 63).
A restriction is an opportunity to control a disproportionate risk arising from a substance. It even takes effect when other REACH instruments have been ineffective. A restriction is initiated by the respective Member States or by the ECHA.
After a dossier is prepared, there follows a consultation phase in which all interested parties have the opportunity to comment on the restriction dossier. The Commission then issues a proposal for inclusion in Annex XVII, and a decision is made in relation to this in the committee procedure.
Further information on restriction, on substances included in Annex XVII, and on which restrictions were proposed by Germany, can be found on the website of the REACH-CLP-Biozid Helpdesk in the section "Zulassung und Beschränkung" (Authorisation and Restriction).