The new European law on chemicals, Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), was adopted by the European Parliament in December 2006, and the first phase went into effect on 1 June 2007. Locus has been on the forefront of the REACH program since 2003, while REACH was in the development stages. Due to the importance and influence of the new legislation, Locus has created a REACH taskforce to help you understand and prepare for REACH.
REACH starts a new era for how the chemical industry and European Union (EU) authorities co-operate to improve safety and control of production, and import and use of chemicals in Europe. From 1 June 2008, chemical producers and importers will face the obligation of pre-registering existing chemical substances in order to benefit from later registration and to register new chemical substances to the European Chemicals Agency (ECHA) in Helsinki. If a company fails to submit a REACH registration dossier on a substance within the relevant regulatory deadline, the company cannot produce or import this substance to the European market.
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Background
REACH was created to improve the protection of human health and the environment through identification of the properties of chemical substances. It gives greater responsibility for industry to manage the risks from chemicals and to provide safety information on the substances. REACH requires manufacturers and importers of chemicals to the EU to gather information on the properties of the chemicals and to register the information in a central database. The regulation also calls for the progressive substitution of the most dangerous chemicals, when suitable alternatives have been identified. Although REACH is an EU directive, its impact will influence a much wider area, as international companies exporting to Europe will also be required to register their products.
The legislation also requires manufacturers and importers of chemicals to submit data on hazard and risk, as well as on the use of all substances manufactured in, or imported into, the EU in quantities of more than one metric tonne per year. It is estimated that more than 30,000 substances will need to be registered. Of those, approximately 1,500 “substances of high concern” will have to go through an authorization process.
Substances produced or imported in quantities over 1,000 metric tonnes per year will have to be registered within 3.5 years. By 2018, all substances will have to be registered. Currently, certain low-risk substances such as polymers, intermediates, and substances regulated by other legislation are totally or partly exempted from registration requirements.
Locus Case Study
In 2003, a consortium of chemicals and oil companies was formed, lead by Chevron Oronite Company, LLC, Ethyl Corporation, Infineum, The Lubrizol Corporation, and Schenectady International, Inc., to evaluate the impact of REACH on U.S. manufacturers operating in Europe. Through the American Chemistry Council Risk Assessment Task Group (ACC RATG), Locus was selected to assist ACC with upcoming REACH regulatory compliance changes in Europe. As a part of the project, Locus interacted with United Kingdom Environmental Agency (EA) and the French environmental regulatory agency, Directions Régionales de l'Industrie, de la Recherche et de l'Environnement (DRIRE). Locus obtained an audience at different levels in Europe to lobby for the ACC cause. Part of Locus' scope of work was to develop a sampling strategy to quantify emissions of specific compounds from European chemical plants and perform sample collection and subsequent analysis. The focus of the study was at para-C12-alkylphenols (dodecylphenol and tetrapropenylphenol [TPP]) lubricant additives and potential environmental risks from the production, blending, and usage of these chemicals in the lubricant and resin industries. The risks were evaluated, relative to potential impact on freshwater and marine aquatic (including sediment) environments and soil, with potential impact to predators. Locus continues to assist the ACC in preparing a lifecycle analysis on specific compounds.
Locus will continue expanding its services to help companies comply with REACH. Our activities will focus on two fronts:
- Assist companies and industry in evaluating the impact of REACH on their operations and provide guidance and strategic consulting for implementing REACH
- Manage electronic submittals. Locus intends to expand its popular LocusFocus environmental portal (ePortal) and EIM to administer and handle REACH submittals. To that extent, Locus has already reviewed submittal requirements and downloaded and installed the International Uniform Chemical Information Database (IUCLID 5) software recently made available by the European Commission.
IUCLID is a software application to capture, store, maintain, and exchange data on intrinsic and hazard properties of chemical substances. It is a key software application essential for the chemical industry to comply with the new REACH legislation, which entered into force on 1 June 2007. While companies can freely download IUCLID, many of them will find it challenging and time-consuming to run.
Locus will assist chemical companies in globally fulfilling their obligation to submit data to the EU Agency under the REACH legislation. Without an appropriate IT tool, it would be extremely difficult for industry, especially for small and medium enterprises, to comply with the REACH data requirements.