Environment Commissioner Janez Potočnik and Industry Commissioner Antonio Tajani announced today (25 March) that they have found a common approach to identifying and managing Substances of Very High Concern (SVHCs).
SVHCs include chemicals that cause cancer, birth defects and other serious health problems. They also tend to persist in the environment and accumulate in the body.
The agreement was announced during a visit by the two commissioners to the European Chemicals Agency (ECHA) in Helsinki.
The commissioners' "common interpretation of the REACH text" breaks the deadlock on substituting hazardous substances and represents a step change compared to the situation that prevailed under the previous Commission.
The agreement clarifies the authorisation procedure for hazardous substances on socio-economic grounds. Under the REACH regulation, even if a substance presents a risk to human health or the environment, authorisation may be granted if the socio-economic benefits are proven to outweigh risks arising from its use and if there are no suitable alternatives.
Under the Commission's new procedure, "all available information is to be considered and will be used in a so-called 'weight of evidence approach'".
In addition, companies which have been unable to identify alternative solutions for a dangerous substance will have to show they have carried out in-depth investigations and must indicate a 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," the Commission stressed.
According to the EU executive, implementation of the amended criteria will be subject to transitional arrangements. It will become mandatory for registrants two years after the entry into force of the agreed criteria, which will be stated in the revised Annex XIII of REACH.
Now that this deadlock has been broken, the Commission says it will shortly give "the long-awaited draft guidance on authorisation" to the ECHA to allow it to make progress on registering chemicals and managing Substances of Very High Concern.
ECHA asked to enlarge the list of hazardous substances
The Commission also asked the European Chemicals Agency to add 106 more substances to the current candidate list of SVHCs, which may need to go through special authorisation procedures before being used.
A roadmap agreed by the EU executive and the ECHA is expected to bring the number of chemicals on the list of SVHCs to 135 by 2012.
New registration tool
Coinciding with the visit, the European Chemicals Agency, which is responsible for managing the implementation of REACH, announced the launch of a new version of its online registration system REACH-IT.
ECHA said the system is accompanied by a new tool allowing companies to verify the technical completeness of a dossier before submitting it.
Meanwhile, instruction manuals for using the new tools are currently only available in English. Work to translate them into the other 21 official EU languages is under way.