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The new European law on chemicals, REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), entered into force on 1 June 2007.
The two most important aims of REACH are:
1. to improve the protection of human health and the environment from the hazards of chemicals and
2. to enhance the competitiveness of the EU chemicals industry
The REACH Regulation gives greater responsibility to industry to manage the risks from chemicals and to provide safety information on the substances. Enterprises that manufacture or import more than one tonne of a chemical substance per year will be required to gather information on the properties of their substances, which will help them manage them safely, and to register the information in a central database. The European Chemicals Agency will act as the central point in the REACH system: it will run the databases necessary to operate the system, co-ordinate the in-depth evaluation of suspicious chemicals and run a public database in which consumers and professionals can find hazard information.
The Regulation also calls for the progressive substitution of the most dangerous chemicals when suitable alternatives have been identified.
Regulation (EC) No 1907/2006
a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition (e.g. individual pigments, solvent chemicals, etc).
mixture or solution of two or more substances (e.g. mixture of pigments & solvents)
an object which during production is given a specific shape, surface or design, which determines its function to a larger degree than its chemical composition (e.g. battery).
Manufacturers and Importers need:
- to register substances they produce or import in quantities over 1 tonne per year. The registration requirement applies to substances on their own, in preparations and in articles under special conditions (intentional release). Failure to register means that the substance cannot be manufactured, imported or used in the EU market.
Downstream users of chemicals need:
- to apply the risk management measures for dangerous substances identified on the supplier Safety Data Sheets. They have a right to make their use of a substance known to the manufacturer in order to make it an identified use and have it covered in their supplier's chemical safety assessment. In this case they have to provide sufficient information to allow the supplier to prepare an exposure scenario for the use.
- alternatively, to conduct own chemical safety assessment and report to the chemicals agency.
Key elements of REACH:
REACH requires registration of all substances manufactured in, or imported into, the EU market in quantities of 1 tonne or more per year. There is a period of pre-registration from 1 June to 30 November 2008. Substances will then need to be registered in tonnage-related tranches between 2008 and 2018. Registration involves submitting a “technical dossier”, containing information on the substance and information on how to effectively manage the risk entailed, to the ECHA. Quantities of 10 tonnes or more per year additionally require the submission of a Chemical Safety Report (CSR) to document the safety assessment of the substance. If your business is placing a NEW substance on the market for the first time, then your business needs to register that substance before it can be placed on the EU market.
A technical dossier includes:
- the identity of the manufacturer(s) or importer(s) as specified in section 1 of Annex VI (3 items);
- the identity of the substance as specified in section 2 of Annex VI (15 items);
- information on the manufacture and use(s) of the substance as specified in section 3 of Annex VI (7 items);
- the classification and labeling of the substances as specified in section 4 of Annex VI (3 items);
- guidance on safe use of the substance as specified in section 5 of Annex VI (10 items);
- study summaries of the information derived from the application;
- robust study summaries of the information derived from the application;
- an indication of reviewed information submitted;
- proposals for testing;
- exposure information for substances in quantities of 1 to 10 tonnes; and
- a request as to which of the information the manufacturer or importer considers should not be made available on the Internet
Evaluation allows the regulatory authorities to decide on proposals for further testing and assess whether information provided by industry complies with the requirements (dossier evaluation). At least 5% of the dossiers registered in each tonnage band will be evaluated. For selected substances, for which a risk to health or the environment is suspected, substance evaluation provides a mechanism to require industry to obtain more information. Evaluation may also lead to the conclusion that action should be taken under the restriction or authorisation procedures.
As with evaluation, not all substances will require authorisation by the ECHA. Authorisation will be required for substance of very high concern (SVHC). Once a substance is placed on a list of substances subject to authorisation, those using it will need to apply for an authorisation for each use of that substance.
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.
European Commission or EU Member States may propose restrictions on the manufacturing, marketing and use of certain dangerous substances and preparations. Any substance on its own, in a preparation or in an article may subject to Community-wide restrictions if its use poses unacceptable risks to health or the environment. Restriction can be decided either for the use of a substance in certain products, the use by consumers or even for all uses (complete ban of a substance).