The European Commission proposed a new EU regulatory framework for the Registration, Evaluation and Authorisation of Chemicals (REACH) on 29 October 2003.
Aims of REACH
The aim is to improve the protection of human health and the environment through the better and earlier identification of the properties of chemical substances. At the same time, innovative capability and competitiveness of the EU chemicals industry should be enhanced. The benefits of the REACH system will come gradually, as more and more substances are phased into REACH.
The European Inventory of Existing Commercial Chemical Substances (EINECS) lists about 100 106 existing substances. Out of these, the number of existing substances marketed in volumes above 1 tonne is estimated at 30 000. These have to be registered.
Registration is the basis of REACH. Manufacturers and importers will be required to gather information on the properties of their substances, which will help them manage them safely, and submit the information in a registration dossier to a central data base. Companies will be required to register all substances produced or imported in volumes of 1 tonne and more per year per manufacturer or importer. A new independent agency at European level will receive the dossiers and manage the database. Information requirements will largely depend on volume, but may be tailored to the intrinsic properties and conditions of use of certain substances.
Information to be provided
Registration will involve providing information on:
- The intrinsic properties and hazards of each substance (such as physicochemical, toxicological and eco toxicological properties). This information - if not already available - can be found through a variety of means such as computer modelling and epidemiological studies, or through testing. Where testing is necessary and involves animals, it will be kept to a minimum by requiring companies to share existing data. This will also reduce the associated costs. Any proposals for testing on animals will also be subject to a 'dossier evaluation'.
- The use(s) of the substance identified by the importer or manufacturer or by their customers. A report of an assessment of risks for human health and the environment, and how those risks are adequately controlled, for the identified uses for substances produced or imported in volumes of 10 tonnes or more per year per manufacturer or importer (known as chemical safety reports). For lower volumes, safety information produced for the safety data sheets will be submitted as part of the technical dossiers.
There are two types of evaluation: dossier and substance evaluation. Both evaluations will be performed by competent authorities in the Member States.
Dossier evaluation will be conducted to check proposals for testing on animals and ensure that unnecessary animal testing is avoided. Registration dossiers can also be subject to a dossier evaluation to ensure their compliance with the registration requirements.
Substance evaluations can be performed when there is reason to believe that a substance may present a risk to human health or the environment (for example, because of its structural similarity to another substance or for other reasons). Therefore, substance evaluations will look at all the registration dossiers submitted for the same substance and take into account any other available information. It is expected that substance evaluations will focus on those substances that may pose the greatest risk to human health and the environment. The Agency will develop risk-based criteria to assist with the prioritisation of substance evaluations.
To help ensure that the system operates efficiently, a competent authority from one Member State will be designated in each case to carry out an evaluation based on rolling plans they will develop, setting out the substances they will evaluate. The outcome of an evaluation may be that the registrant(s) have to provide additional information, either to bring their registration into compliance with the requirements or to help clarify risks.
If all Member States agree to request more information, the Agency will take the decision. If not, the Commission decides whether or not more information should be requested.
All substances of very high concern will be subject to authorisation. Authorisations apply to particular uses of the substance in question. Authorisation will be granted only if the producer or importer can show that risks from the use in question can be adequately controlled, or that the socio-economic benefits of the use of the substance outweigh the risks. In the latter case, the possibility of substitution should be considered.
The authorisation decision will take into account substitution plans showing for example that the industry is researching substitutes. Third parties will also be able to provide information to the Agency about possible substitute substances or technologies.
Examples of substances that will be subject to authorisation are:
- CMRs (carcinogenic, mutagenic or toxic to reproduction), category 1 and 2,
- PBTs (persistent, bio-accumulative and toxic),
- vPvBs (very persistent, very bio-accumulative).
- Substances identified as having serious and irreversible effects to humans and the environment equivalent to the other three categories, for example certain endocrine disrupting substances (substances disturbing the body's hormone system). These will be identified on a case by case basis and be subject to authorisation.
To cope with the large number of 'existing' substances a phased approach is proposed. The deadlines for registration are set according to the volume of the substance on the market or the hazard. Substances produced in high volumes and CMRs will have to be registered first. Registration deadlines will be calculated from the year the legislation enters into force so that the new obligations will apply from:
- year 3 for high production volume chemicals (1,000 tonnes or more/year/ manufacturer or importer) and CMRs in volumes of 1 tonne or more;
- year 6 for production volumes in the range of 100 - 1,000 tonnes;
- year 11 for low production volume chemicals (1 - 100 tonnes).
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