The European Chemicals Agency (ECHA) was officially opened on 3 June. Located in Helsinki, ECHA is responsible for managing the implementation of the REACH requirements in relation to the registration, evaluation, authorisation and restriction processes of chemical substances.
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 1st June 2008 two key processes of REACH entered into operation: Registration of chemicals and pre-registration of the some 30,000 chemicals currently in use (e.g. acids, metals, solvents, surfactants). Manufacturers or importers of chemicals have to pre-register them by 1 December 2008 if they want to continue manufacturing or importing them without interruption. It has been estimated that over 180,000 pre-registration files will be submitted.
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 the Agency.
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 pre-register them at the Agency between 1st June and 1st December 2008.
Pre-registering requires submitting basic information to the Agency: details of the company and the name of the chemical concerned. It is free of charge.
The pre-registration 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 pre-registration deadline, as in this case they must stop manufacturing or importing the substance until they submit a full registration dossier.
Evaluation
Evaluation is the process where on the basis of information provided regulatory authorities decide 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 toxic to the reproductive system
– substances which are persistent, bio-accumulative and toxic or very persistent and very bio-accumulative substances
– endocrine disrupters, as identified on a case-by-case basis
Currently, more than 1000 such substances are known. REACH provides for a process to identify substances for inclusion on a candidate list which ECHA will publish on its website. The first list, established by the Agency following comments by interested parties, is expected to be available on the Agency’s website from early 2009.