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Registration and authorisation for safer chemicals in the EU - briefing

25 March 2010
by eub2 -- last modified 25 March 2010

European Commission Vice President Tajani and Commissioner Potočnik on 25 March announced EC action to make progress towards the registration of chemicals and the management of substances of very high concern. This memo focuses on action being taken for European companies, in particular for SMEs, towards the approaching deadline of 30 November 2010 under REACH. It also provides background information regarding substances of very high concern and authorisation, where substantial progress has been reached.


1. 30th November REACH registration deadline and guidance for SMEs

By 30 November 2010 companies need to document the risk management of chemicals by sending a registration dossier to the European Chemicals Agency, ECHA. This is necessary for the continuation of production and marketing of substances manufactured or imported above 1000 tonnes per year, of some substances with specific hazardous properties (e.g. CMR) above 1 tonne per year, and for substances very toxic to the aquatic environment above 100 tonnes per year.

To support companies in meeting this ambitious goal, ECHA is responsible for providing guidance and tools for the different processes of REACH. There is substantial progress on their translation, especially those on registration, so making it easier for SMEs to register.

Registering a substance jointly with other companies

Those producing or importing chemicals have to submit a registration dossier to ECHA consisting of a common part prepared and submitted together with other manufacturers or importers of the same substance (by a so-called "Lead Registrant"), and an individual part containing information that is specific to the company.

To prepare their dossier, companies will need to share data with others in a Substance Information Exchange Forum (SIEF). SIEFs bring together businesses registering the same substance so they can share data on it. This reduces costs, avoids duplication of animal testing, and allows SMEs to benefit from data gathered by bigger companies, which should be exchanged for a fair price.

Action to speed up the formation and operation of SIEFs

The Directors Contact Group on Registration has been recently set up to accelerate the process of formation and operation of the SIEFs, in view of the fast approaching deadline of 30 November 2010. The Group has already identified solutions to most of the issues raised and so is contributing to easing the registration process. It will also make a more accurate estimate of the number of substances we can expect to be registered in 2010.

The Group comprises director-level representatives of the Commission, ECHA and 6 industry associations representing SMEs and most companies having to register chemicals by this first deadline.

More information?

The ECHA website has specific web pages on SIEFs, and also provides the guidance documents and IT tools and Frequently Asked Questions. There is also a REACH/CLP national helpdesk in every EU country and an ECHA helpdesk. Industry associations, the Enterprise Europe Network and chambers of commerce can also help companies, especially SMEs.

2. Criteria for the identification of persistent, bioaccumulative and toxic substances (Annex XIII)

Commissioner Potoc(nik and Vice-president Tajani announced also the agreement reached on setting the criteria for the identification of persistent, bioaccumulative and toxic substances, or very persistent and very bioaccumulative. All available information is to be considered and will be used in a so-called "weight of evidence approach"

The assessment of these so-called "PBT/vPvB" properties is relevant for registration and authorisation. These criteria were awaited for more than a year.

Given the approaching of the first registration deadline under REACH, the Commissioners have foreseen transitional measures for the smooth implementation of these criteria. For the registrants, the implementation of the new criteria will be become mandatory only 2 years after the entry into force of the agreed criteria. These criteria will be stated in the revised annex XIII of REACH.

3. Identification of substances of very high concern

The REACH Regulation sets up a system under which the use of Substances of Very High Concern (SVHCs) may be subject to prior authorisation. The aim of authorisation is to ensure that risks from SVHCs are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies, where these are economically and technically viable.

Once a substance is on the candidate list it triggers immediate obligations of information regarding this substances (for instance, if it is present in consumer articles), to ECHA, and in the supply chains, up to consumers. Substances on this list may be also made subject to authorisation, following a prioritisation process.

As from today, the substances on this list, known as the "candidate list", will be enlarged as the Commission will ask ECHA to propose further substances to go on it, bringing the total to 135. This decision shows that the Commission is seeking concrete results in the authorisation process. The Commission will also collaborate with the Member States to obtain the best results.

When a new substance is proposed for this list, its further treatment is followed up in a public consultation, an opinion by the Member State Committee of ECHA, and a final decision from the Commission. The Commission supports a pragmatic approach to the inclusion of substances on this list, taking into account their adequacy for the authorisation process (as the best option compared to other REACH mechanisms to manage the risks linked to the substance), as well as prioritisation procedures and the capacity of ECHA to handle the proposal. The Commission is also collaborating with the Member States, with whom the workload is shared for the identification of these substances and their prioritisation for inclusion in Annex XIV (which makes them subject to authorisation)

Guidance on inclusion of substances in Annex XIV (List of Substances Subject to Authorisation) - ECHA factsheet

4. Authorisation of substances of very high concern

The long-awaited guidance that companies can follow for their future applications for authorisation will now soon be published: the Commissioners for Industry and Environment agreed on a common interpretation of the REACH text which lifts the deadlock that had blocked agreement on this matter for several years.

The agreement clarifies technical matters related to the content of a dossier for application for authorisation on socio-economic grounds, i.e. substances may be authorised if their socio-economic benefits outweigh the risks linked to them.

At the same time the guidance is also reinforcing the importance of the analysis of alternatives for an authorisation to be granted: an applicant who has not been able to identify alternative solutions will not only have to show he has carried out deep investigation but should also indicate the timeline within which alternative substances could become available. Therefore substitution fully remains an objective in the authorisation process, even if it cannot be effected immediately.

On this basis, the Commission is ready to finalise the guidance on authorisation as quickly as possible and adopt the first list of substances that are subject to authorisation without delay.

European Chemicals Agency

Source: European Commission