(ECHA: Brussels, Belgium) -- Vice president Tajani and commissioner Potočnik are taking action to make progress toward the registration of chemicals and the management of substances of very high concern. Of particular importance, is the smooth implementation of the registration of high-volume chemicals by the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation deadline of Nov. 30, by implementing solutions to practical problems to support industry’s work, in particular SMEs, which are medium-sized, small, and micro enterprises.
During their visit to the European Chemicals Agency (ECHA) in Helsinki, Finland, on March 25, both commissioners also announced their common approach on the identification and management of substances of very high concern. They also welcomed progress on the translation of the guidelines for the implementation of REACH. Both commissioners underlined their commitment to the success of REACH, the European chemicals regulation.
“REACH is a key example of balance striking between the three pillars of sustainable development: competitiveness, social, and environment. REACH ensures a high level of protection of human health and the environment, while also playing an important role to encourage innovation, foster competitiveness, and better enable enterprises meet essential demands of consumers,” notes vice president Antonio Tajani, commissioner for industry and entrepreneurship, and Janez Potočnik, commissioner for environment, in a joint statement.
“These announcements are extremely welcome. Taken with the vice president and commissioner’s visit here today, they signal that the [European] Commission and ECHA stand side by side in making REACH work to the benefit of European citizens and our environment,” says Geert Dancet, executive director of ECHA.
During their visit, the commissioners discussed the following issues with ECHA and stakeholders.
Nov. 30, 2010, is the deadline under REACH for registration of highest volume chemicals, as well as known particularly hazardous substances. Manufacturers and importers have to document their management of risk of chemicals in their registration files to be able to continue their production and marketing. It’s estimated that about 9,000 substances are covered.
In this context, Tajani highlighted progress in making it easier for enterprises, in particular SMEs, to successfully register chemicals, for instance via Substance Information Exchange Foras (SIEF), which bring together businesses registering the same substance so they can share data on it. This reduces costs and avoids duplication of animal testing.
A Directors Contact Group, chaired by the European Commission, is currently monitoring industry’s preparedness toward the deadline of Nov. 30 and implementing solutions to practical problems where needed. It’s composed of director-level representatives of the European Commission, ECHA, and industry associations producing chemicals at high-volumes, or representing SMEs.
Furthermore, ECHA has made substantial progress on the translation in all European Union official languages of the guidelines and tools for REACH, especially those on registration, making it easier for SMEs to register.
Commissioner Potočnik 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 authorization. These criteria were awaited for more than a year. For the registrants, the implementation of the amended criteria will be subject to transitional arrangements and will become mandatory only two years after the entry into force of the agreed criteria. These criteria will be stated in the revised Annex XIII of REACH.
The European Commission is determined to identify additional substances of very high concern (SVHC) for inclusion in the so-called “candidate list,” which currently contains 29 substances. In this context, both commissioners, after consulting ECHA, agreed on a road map for the inclusion of 106 priority SVHC substances by 2012. The European Commission also calls on the member states to make their contribution.
When a new substance is proposed for identification as SVHC, its further treatment is followed up in a public consultation, and an opinion by the member State Committee of ECHA before its actual inclusion into the candidate list.
A substance placed on the candidate list triggers an obligation on the producer to provide information on that substance, for instance information on products that contain it. This information needs to address the entire supply chain, from producer to consumer.
Substances on this list may be made subject to authorization, following a prioritization process and their inclusion in the authorization list (Annex XIV).
Both commissioners announced that the long-awaited draft guidance on authorization will shortly be provided to ECHA. The authorization procedure is one of the risk management options that REACH foresees for substances of very high concern (see MEMO/08/360)
REACH entered into force in 2007 and overhauled the former legislative framework on chemicals, which had been slow and showed limited efficiency. Its provisions regarding registration and authorization entered into force in 2008.
The European Chemicals Agency, located in Helsinki, Finland will manage the registration, evaluation, authorisation and restriction processes for chemical substances to ensure consistency across the European Union. These REACH processes are designed to provide additional information on chemicals, to ensure their safe use, and to ensure competitiveness of the European industry.
In its decision-making the Agency will take the best available scientific and technical data and socio-economic information into account. It will also provide information on chemicals and technical and scientific advice. By assessing and approving testing proposals, the Agency will minimize animal testing.
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