What does Registration mean for you?

REACH Regulation (EC) No 1907/2006, which came into force in 2007, requires manufacturers and importers to register with the European Chemicals Agency (ECHA) all substances or mixtures of substances that are manufactured or imported in quantities of one tonne or more per year.

The basic principle is: "No Data, no Market". This means that you may not manufacture, import or purchase a substance in the EU that has not been registered.

The registration deadlines were spread over eleven years and were based on tonnage. Since then, all substances that are manufactured or imported from 1 t/a per company must be registered.

Various exemptions, e.g. for certain recycling and intermediate products, polymers or pharmaceuticals, apply to the registration of substances.

For more information on registration, deadlines and exemptions, please visit the REACH-CLP-Biozid Helpdesk website.

What does Evaluation mean?

The REACH Regulation provides two different evaluation processes: dossier evaluation and substance evaluation.

Dossier Evaluation

In this process, ECHA evaluates the content of submitted registration dossiers. ECHA checks whether all the requirements to be met under REACH are fulfilled (Compliance Check, CCH). Another form of dossier evaluation is the Testing Proposal Examination (TPE). A registrant must submit such a testing proposal if there is a data gap in his REACH dossier.

Substance Evaluation

In this process, the European Member States evaluate the totality of the data available on a substance or group of substances to determine whether the substance or group of substances poses a risk to humans or the environment in relation to its intrinsic properties or uses. Member States consider whether the data are sufficient to confirm or exclude this concern, i.e. to identify a risk or to conclude that the suspicion of risk no longer needs to be raised.

If the existing data are not sufficient, the evaluating Member State prepares a draft decision and requests the missing information from the registrants. If the available data is sufficient, a conclusion on the evaluation and, if necessary, on possible follow-up steps is prepared. This information is then published by ECHA.

In both processes, the registrants of the respective substances are involved and asked to comment on the draft decisions in case of information requests.

Are you a registrant affected by the dossier or substance evaluation? Or would you like to know more about the individual processes? Please follow the link below to access the REACH-CLP-Biozid Helpdesk website.

What is the role of the Candidate List and Annex XIV?

Under REACH, substances may be subject to authorisation in a two-step process. This concerns substances with carcinogenic, mutagenic or toxic to reproduction (CMR) properties and substances that are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB). In addition, substances with similar properties of concern that are not further specified in the REACH Regulation, e.g. endocrine disrupters or respiratory sensitisers, can also be included in this process.

In the first step of the process, these substances must be identified as "substances of very high concern" (SVHC) and included in the candidate list. Substances on the candidate list can still be manufactured, used and placed on the market. However, there are certain information and notification requirements if these substances are present in articles above concentration limits of 0.1%.

At irregular intervals, but at least every two years, selected substances on the candidate list are prioritised by ECHA. Subsequently, the EU Commission, with the participation of the Member States, decides whether and which substances prioritised by ECHA are to be included in Annex XIV. After a transitional period, these substances may no longer be placed on the market or used without authorisation, with a few exceptions.

Users, importers or manufacturers can apply to ECHA for an authorisation for a specific use. The EU Commission, with the participation of the Member States, decides on each application for authorisation on the basis of the opinions of the Risk Assessment Committee and the Socio-economic Analysis Committee based at ECHA.

For a more detailed description of the process and the conditions under which an authorisation can be granted, see the links section at the bottom of the page.

When is a substance restricted under REACH?

A restriction under REACH means that a substance is no longer permitted for use or for inclusion in an article or mixture. These restrictions are listed in Annex XVII of the REACH Regulation. An example is 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 can be highly individualised and is therefore a precise tool to control an unacceptable risk posed by a substance. A restriction is initiated by Member States or ECHA.

After a dossier has been prepared, there is a consultation period during which all interested parties have the opportunity to comment on the restriction proposal and to submit new information. This information is examined and may lead to additions or changes to the proposal. Finally, the Commission prepares a proposal for inclusion in Annex XVII, which is subject to a decision under the comitology procedure.

Further information on restriction, the substances included in Annex XVII and the restrictions proposed by Germany can be found on the REACH-CLP-Biozid Helpdesk website under Authorisation and Restriction.