Registration Evaluation and Authorization of Chemicals (REACH)
Last updated by ess-home on 9/24/2008
European Chemicals Agency (ECHA) - European Union
REACH (Registration, Evaluation and Authorization of Chemicals) is the European Union (EU) chemicals legislation that potentially impacts every product supply chain that touches on the EU. It governs the EU manufacture, import into the EU, and placing on the market in the EU, of chemical substances on their own, in mixtures and in articles throughout their entire life cycle, including waste disposal. Every product that is exported into the EU will potentially be affected.
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Meet the requirements of this regulation with IHS solutions for:
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The aim of REACH is to ensure the protection of human health and the environment from the effects of chemicals used in, or introduced into, the EU while at the same time ensuring that there is a true single market (read ‘level playing field') in chemicals (on their own and in articles). Its requirements strongly encourage the use of safer chemicals over more dangerous ones and set out to specifically ensure that ‘substances of very high concern' (SVHCs – the most dangerous substances used) are, over time, substituted by safer alternatives.
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Management System and Data Management Implications
Identifying, tracking and meeting your regulatory duties requires the management of substantial amounts of information. Identifying and effectively communicating with your supply chain (both up and down) requires the management and coordination of substantial amounts of information. Failure to do so effectively, in either case, could have a massive business impact ranging from loss of supply of key products supplied to you to the loss of key customers and markets for your products.
To effectively manage data and demonstrate compliance with these requirements, a data management system can be useful to track:
- Tasks assigned and tracked to completion.
- Data Maintenance and Management
- Substance and Preparation Volume Tracking
- Substance and Preparation Property Management
- Usage and Exposure management
- Substance Inventory
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Fast Facts
| Jurisdiction |
European Union (EU) |
| Applicability |
All product supply chains that touch on the EU will be affected. In particular
- EU manufacturers of substances
- EU importers of products (substances, mixtures and articles)
- Non-EU companies that import products from the EU
- Non-EU companies that sell products to the EU
- Users of products from, and within, the EU
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| Regulatory Driver |
Regulation (EC) No 1907/2006 of the European Parliament on December 18, 2006 |
| Promulgating Entity |
ECHA (European Chemicals Agency) |
| Enforcing Entity |
ECHA (European Chemicals Agency) |
| Entity Summary |
http://reach.jrc.it/about_reach_en.htm |
| Regulatory Text |
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:396:0001:0849:EN:PDF |
| Regulatory Submissions Required |
All manufacturers and importers of chemicals must identify and manage risks linked to the substances they manufacture and market. For substances produced or imported in quantities of 1 tonne or more per year per company, manufacturers and importers need to demonstrate that they have appropriately done so by means of a registration dossier, which shall be submitted to the Agency.
Once the registration dossier has been received, the Agency may check that it is compliant with the Regulation and shall evaluate testing proposals to ensure that the assessment of the chemical substances will not result in unnecessary testing, especially on animals.
Where appropriate, authorities may also select substances for a broader substance evaluation to further investigate substances of concern.
REACH also foresees an authorization system aiming to ensure that substances of very high concern are adequately controlled, and progressively substituted by safer substances or technologies or only used where there is an overall benefit for society of using the substance. These substances will be prioritized and over time included in Annex XIV. Once they are included, industry will have to submit applications to the Agency on authorization for continued use of these substances. In addition, EU authorities may impose restrictions on the manufacture, use or placing on the market of substances causing an unacceptable risk to human health or the environment.
Manufacturers and importers must provide their downstream users with the risk information they need to use the substance safely. This will be done via the classification and labeling system and Safety Data Sheets (SDS), where needed.
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More Information
For details about how the IHS solutions can help your organization comply with REACH, call 800.289.6116 or email us.