European Chemicals Agency is Launched
June 4, 2008 // Published as a news service by IHS
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The European Chemicals Agency (ECHA) was officially opened on June 3 by representatives of the European Commission (EC) and European Parliament.
Located in Helsinki, ECHA is responsible for managing the implementation of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislative requirements.
ECHA formally began its activities a year ago and its work has been devoted to intensive preparations, including staff recruitment and establishing support structures and procedures.
On June 1, two key processes of REACH entered into operation: registration of chemicals and preregistration of the some 30,000 chemicals currently in use, such as acids, metals, solvents and surfactants.
Manufacturers or importers of chemicals have to preregister them by Dec. 1, 2008 if they want to continue manufacturing or importing them without interruption.
It has been estimated that over 180,000 preregistration files will be submitted.
José Manuel Barroso, EC president, said, "The establishment of ECHA is a key milestone in turning the new European chemicals legislation REACH into reality. This will significantly improve health and the environment to the benefit of Europe's citizens. The commission has made exceptional efforts to ensure that this agency has got off to a successful start and the very strong support from Finland has been invaluable."
Günter Verheugen, EC vice president responsible for enterprise and industry policies, said, "ECHA will play a key role in ensuring that companies will be able to comply with REACH, which will have important effects throughout Europe's manufacturing industry. REACH will encourage innovation, foster competitiveness and better enable enterprises meet essential demands of consumers."
Stavros Dimas, EC environment commissioner, said, "REACH is the most ambitious chemicals legislation in the world, designed to protect the environment and the health of European citizens from potentially dangerous chemicals. Through REACH more information will be publicly available on hazardous chemicals found on the market, in the workplace and the environment, and the chemicals industry will be expected to innovate to find safe alternatives to substances of great concern."
Registration
REACH requires companies that manufacture or import chemicals above one tonne per year to gather data regarding the health and environmental properties and risks of their chemical and demonstrate that it can be used safely. They need to document this in a technical dossier and submit it to ECHA in order to satisfy registration requirements.
New chemicals need to be registered before they can be manufactured or put on the market. For existing chemicals, companies can benefit from phased registration deadlines (2010, 2013, 2018, depending on the tonnage produced), provided they preregister them at ECHA between June 1 and Dec. 1, 2008.
Preregistering requires submitting basic information to ECHA: details of the company and the name of the chemical concerned. It is free of charge.
The preregistration process will enable companies to share data on their chemicals, thus avoiding unnecessary animal testing and reducing cost. Manufacturers and importers should not miss the preregistration deadline, as in this case they must stop manufacturing or importing the substance until they submit a full registration dossier.
Evaluation
During the evaluation process, regulatory authorities decide, on the basis of information provided, if deeper examination of a substance is needed and assess what further information needs to be provided by industry for that purpose. This information may lead to further risk management actions under the restrictions or authorisation procedures.
Authorisation
Substances of very high concern are subject to an authorisation procedure. Companies applying for authorisation need to show that the risks posed by those substances are adequately controlled or that the socio-economic benefits from their use outweigh the risks. The aim is that these substances are progressively replaced by suitable alternatives when technically and economically feasible.
Substances of very high concern include:
- Carcinogens, mutagens or substances that are toxic to the reproductive system.
- Substances that are persistent, bio-accumulative and toxic, or substances that are very persistent and very bio-accumulative.
- Endocrine disrupters, as identified on a case-by-case basis.
Currently, more than 1,000 such substances are known. REACH provides for a process to identify substances for inclusion on a candidate list that ECHA will publish on its web site. The first list, established by ECHA following comments by interested parties, is expected to be available in early 2009.
ECHA has made a wide range of guidance documents and tools available to help companies, in particular to small and medium-sized enterprises.
More information
For further information, see:
Source: European Commission.