EU reforms Chemicals Legislation
The European Commission is completely reforming its legislation concerning chemicals. The main purpose is to improve risk control and shift the responsibility for risk control to the industry. New legislation will enter into force this June.
The new legislation, introduced under the name of REACH, was published on December 30 last year. The CBI will look into the consequences of the long and complex REACH legislation texts for exporters in developing countries.
REACH, which stands for Registration, Evaluation and Authorisation of Chemicals, essentially states that a company that produces, uses or supplies chemicals to customers, should know the risks of a substance and should appoint suitable risk control measures. The main implication of this new approach is that the responsibility for adequate risk control has now been shifted towards the industry.
The reason for this change in policy is the lack of sufficient data on the hazards and risks of many chemical substances available on the EU market. Some chemicals can be irritant, toxic and corrosive; they can cause cancer, mutations and reproductive problems. A fact sheet of the European Commission explains that 99% of chemicals (by volume) are backed by sketchy information on properties, uses and risks. Chemicals that are marketed in high volumes have been examined more closely, but even in that category about 21% come with no data at all and another 65% with insufficient data.
Registration requires producers and importers to obtain relevant information on chemical substances produced in or imported into the EU at quantities higher than 1 tonne per year. Registration involves a technical dossier containing information on the substance and on how to effectively manage the risk involved in its use. For quantities higher than 10 tonnes per year, a Chemical Safety Report needs to be submitted to document the safety assessment of the substance.
Through thorough evaluation, the public authorities of EU member states will look more closely at the registration dossiers and the substances of concern. If necessary, they can request more information.
Authorisation may be required for substances of very high concern: carcinogens, mutagens, substances toxic to the reproductive system, and substances which are persistent, bio-accumulative and toxic, very persistent and very bio-accumulative or of equivalent concern.
Restrictions are safety net of the system. Any substance on its own, in a preparation or in an article, may be subject to Community-wide restrictions if its use poses unacceptable risks to health or the environment. Different types of restrictions are possible - restrictions on the use of the substance in certain products, on the use by consumers or on all uses.
The REACH Regulation not only applies to substances and preparations put on the EU market, but also to ‘substances in articles’. These are potentially hazardous substances released from articles as part of their function, such as textiles, cars or electronic chips. Substances that are released intentionally will generally have to be registered. If the release is not intentional, then only the substances of very high concern have to be notified.
If the total amount of a particular substance in an article is higher than 1 tonne per year and this substance is released intentionally from the article, registration is compulsory according to the normal rules. Substances of very high concern that are present in articles above a concentration limit of 0.1% (w/w) and in volumes above 1 tonne per year, must be reported unless exposure to humans and the environment can be excluded. These will be marked on a list that is to be produced by the Chemicals Agency.
Although importers are responsible for compliance with REACH, the extensive information required from them is likely to bring about requests for detailed information from their suppliers.
Source: CBI News bulletin, March-April, 2007
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Stages for implementing REACH Regulation
June 2007: Entry into force of REACH
June-Nov.2008: Pre-registration of so-called phase-in substances
June 2008: Registration of new substances
November 2010: Registration deadline for substances in quantities of 1000 tonnes and above as well as carcinogens, mutagens, and substances toxic to reproduction (CMR category 1 and 2) above 1 tonne per year and substance classified as very toxic to aquatic organisms above 100 tonnes.
June 2013: Registration deadline for substances in quantities of 100 tonnes
June 2018: Registration deadline for substances in quantities of 1 tonne and more Voluntary registration is always possible. Dossiers can be submitted as of June 2008. |
