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1. Pre-registration
Chemical substances that are on their own, in preparations and those which are intentionally released from articles have to be registered to the ECHA. This applies to substances manufactured in, or imported to the EU in annual quantities of one tonne or more per legal entity. The chemicals currently on the EU market which meet the definition of phase-in substances should have been pre-registered by 1st December 2008, or within 6 months for first time importers of quantities over a tonne.
Companies who pre-register their substances can benefit from extended registration deadlines. The deadline depends on the tonnage band and the hazardous properties of the substance.
2. Registration
Under REACH, each producer and importer of chemicals in volumes of 1 tonne or more per year per producer or importer will have to register with the European Chemicals Agency, submitting information on chemical properties and uses as well as safety measures for handling the chemicals.
For the purpose of registration, the registrant can use existing scientific data or share data with other registrants within a Substance Information Exchange Forum (SIEF) if the chemical concern is identical.
The registration dossier includes:
- Technical Dossier (for substance >1 t/a): company information and substances identity; manufacture and uses, guidance on safe use, exposure information, classification and labeling; robust study summaries and proposal for testing
- Chemical Safety Report (CSR) which includes hazard and PBT assessment, exposure assessment, risk characteristics and exposure scenarios
3. Evaluation
There will be a dossier evaluation and a substance evaluation. Public authorities will review the registration dossiers and may request additional information when deemed necessary. At this stage, the authorities will scrutinize all proposals for animal testing and may suggest alternative methods whenever possible. One of the main objectives of REACH is to minimize animal testing and make sharing experimental data compulsory.
4. Authorization
Substances of Very High Concern (SVHC) suggested by EU member states or ECHA will be gradually included in Annex XIV of REACH regulation. Once included in Annex XIV, the SVHC cannot be placed on the market or used after a date to be set (so-called "sunset date") unless the company is granted an authorization for specific use. Authorization is independent from Registration and Evaluation and applies without tonnage requirement. Applicants will have to demonstrate that risks associated with uses of these substances are adequately controlled or that the socio-economic benefits of their use outweigh the risks. Applicants must also analyze whether there are safer suitable alternative substances or technologies.
If there are, they must prepare substitution plans, if not, they should provide information on research and development activities to prove no alternatives exist at the moment.
UPDATE: In June 2009, the Member State Committee approved ECHA’s recommendation for seven (7) substances from the ‘Candidate List’ of 15 substances of very high concern (SVHC) that should not be used without specific authorization. The final decision on the inclusion will be taken by the European Commission under REACH Article 133 comitology procedure. To view the list and learn more read more on our technical bulletin (PDF 152 KB).
5. Notification
Notification applies to articles. The manufacturer or importer shall notify the ECHA if SVHCs in the articles meet the following 2 conditions:
- The SVHC is present in those articles above a concentration of 0.1% and
- The SVHC is present in the article in quantities totaling over one tonne per manufacturer or importer per year
The ECHA may require the manufacturer or importer to submit a Registration if the SVHC is suspected to be released under normal or reasonably foreseeable conditions of use and presents a risk to human health and the environment.
6. Information in the supply chain
EU or EEA suppliers of articles which contain substances on the Candidate List in a concentration above 0.1% (w/w) have to provide sufficient information, available to them, to their customers or upon request to consumers within 45 days of the receipt of this request. This information shall ensure safe use of the article and shall as minimum contain the name of the substance.
UPDATE: In Oct 2008, the European Chemical Agency published the first list of 15 substances of very high concern. To view the list and learn more read more on our technical bulletin (PDF 177 KB).
7. Restriction
REACH will impose restrictions on substances on their own, in preparations or in articles to regulate the manufacture, placing on the market or use of dangerous substances in the European Community if they pose an unacceptable risk to human heath or the environment.
Annex XVII of REACH regulation laid down a list of restricted substances, specifying which uses are restricted. Uses that are not specifically restricted are allowed unless they are subject to control under other Community regulations or national laws.
UPDATE: The existing restrictions set out in Directive 76/769/EEC, such as the ban on asbestos and restrictions on the uses of certain azo-dyes, was carried over in a consolidated version into the REACH Regulation in June 2009. Learn more on our technical bulletin (PDF 161 KB).
Download REACH Global Services brochure (Chinese) (PDF 641 KB).
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