REACH and CLP
REACH is the European Regulation ((EC) No 1907/2006) on Registration, Evaluation, Authorisation and Restriction of Chemicals. It entered into force on 1st June 2007. It streamlines and improves the former legislative framework on chemicals of the European Union (EU).
The main aims of REACH are to improve the protection of human health and the environment from the risks that can be posed by chemicals, the promotion of alternative test methods, the free circulation of substances on the internal market and enhancing competitiveness and innovation. REACH makes industry responsible for assessing and managing the risks posed by chemicals and providing appropriate safety information to their users. In parallel, the European Union can take additional measures on highly dangerous substances, where there is a need for complementing action at EU level.
The CLP Regulation (for “Classification, Labelling and Packaging”) is the European Union regulation (EC) No 1272/2008, which aligns the European Union system of classification, labelling and packaging of chemical substances and mixtures to the Globally Harmonised System (GHS).
ARCHE Consulting’s team members are well versed in the different disciplines needed to comply with REACH and CLP. Our environmental experts, ecotoxicologists, toxicologists and exposure experts are ready to help you keeping REACH under control. Besides of preparing REACH dossiers the experts of ARCHE Consulting have been actively involved in writing guidance on the subject (metals specific REACH guidance document MERAG), developing new REACH tools that facilitate implementing REACH (DU Scaling tool, intelligent testing strategy tools, soil PNEC calculator), testing of beta versions of IUCLID 6 and CHESAR 3 for ECHA.
The experts at ARCHE Consulting can help you at every step of your REACH and CLP obligations:
- Review of your obligations as importer, manufacturer or downstream user under the REACH and CLP Regulation to safeguard the access of your products to the European market
- Review of the already existing information of the substance under scrutiny and assessment of its suitability for use in the dossiers
- Conduct of a data search for all relevant and available information in scientific literature and acquisition of copies of any literature papers necessary for the dossier
- Data-gap analysis, proposal for waivers, non-testing approaches (e.g. read-across, QSARs) or testing as appropriate
- Justification and documentation of read-across approaches according to ECHA’s Read-Across Assessment Framework (RAAF)
- Preparation of the technical dossier in IUCLID 6 format, including development of robust study summaries, endpoint summaries, waiver statements etc.
- Preparing an overview of the supply chain, use maps, general information on production/use/disposal/recycling and possible grouping of sector for the purpose of data extrapolation and development of specific environmental release categories (SPERC)
- Development of exposure scenarios for the identified end uses or categories of end uses incl. the proposals for Risk Management Measures (RMM), where appropriate and reporting in the standardized format (e.g. in CHESAR)
- Documentation of the Chemical Safety Assessment (CSA), including the proposed classification, the DNEL and PNEC derivation and writing the Chemical Safety Report (CSR)
- Preparation of relevant extended Safety Data Sheet(s) (e-SDS)
- Updates of registration dossiers according to the new data and new guidance from ECHA
- Authorization and restriction dossiers.
IMOA has worked for the last five years with the environmental scientist working at ARCHE, and they have proved for IMOA/Mocon to be a very wise investment. We can therefore highly recommend ARCHE with regard to their technical expertise and knowledge on environmental issues (aquatic and terrestrial), organisation of research projects and data interpretation. ARCHE worked with numerous metal consortia for REACH and is widely recognized by the metals industry as the experts in their field.
ICL-IP has been working with ARCHE over the last couple of years on several projects related to REACH, including preparation of dossiers and exposure scenario’s. We are very satified with them, mainly due to the high quality of work, in-house expertise, rapid response to queries, short communication lines and good price-quality ratio. Therefore, ARCHE is highly recommended by us for projects related to REACH.
The Precious Metals sector has worked with ARCHE on a number of projects involving the environmental and waste stage risk assessment of metals since 2007, when they were still organised under the name of EURAS. ARCHE’s team gathers passionate, dedicated, and very clever though humble profiles which strive to find a robust balance between industry’s commitment to use chemicals safely, and regulations’ thirst for information, justification, and continuously improving scientific evidence. ARCHE colleagues hold experience and expertise in eco-toxicity, risk management, classification of metals (you need to see what MeClas can do for you!), supported by professional project management skills and excellent mathematical, modelling and statistical tools that they somehow manage to make accessible and understandable to any audience (another proof of their humbleness)! ARCHE is certainly one of the European precious metals’ sector’s consultancy of choice, not only for REACH Registration and CLP/GHS support, but also in preparation of challenges under the other titles of REACH!.