REACH Services. Global Service Provider to the Chemical Industry

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1 REACH Services Global Service Provider to the Chemical Industry

2 Welcome to Eurofins REACH Services Eurofins is a global service provider to the chemical industry, offering a comprehensive range of REACH consultancy and REACH testing. We are backed by a large team of experienced scientists and regulatory specialists that are available to support you with all steps of the regulatory process. This includes both phase-in and the non-phase-in substances.

3 REACH Support The REACH Regulation (EC) No 1907/2006 became effective as of June 1, 2007 creating a single registration system for both new and existing chemicals in Europe. The main objectives of REACH are to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. REACH Deadlines 1 June 2007 REACH into Force 1 June 2008 REACH into Operation 1 December November May May 2018 Pre-registration Setup of European Chemicals Agency Registration of: 1 tonne/ year CMR (Carcinogenic, Mutagenic, Reprotoxic) 100 tonnes/ year very toxic to the aquatic environment 1000 tonnes/ year tonnes/ year 1-10 tonnes/ year tonnes/ year New Substances Each manufacturer and importer of chemical substances (>1 t/a) need to obtain information on the physicochemical, health and environmental properties of their substances and submit a registration dossier documenting the data and assessments to the European Chemicals Agency (ECHA).

4 Challenges Ahead At this point, companies are looking ahead to the future registration deadlines. Compared to the previous 2010 deadline a larger number of small-to-medium enterprises (SMEs) will be affected. Some will be able to buy a Letter of Access of existing registrations but for many companies this won t be an option. They will need to get active to build their own dossier or hope someone will take the lead position. As the next registration deadlines covers less widely used substances, it is likely that less data will be available to fulfill the REACH requirements. Therefore we encourage our clients to start planning in an early stage to ensure laboratory and regulatory capacity. Our technical experts can support you in several ways to ensure meeting your REACH obligations. This could be developing global registration strategies, identifying and filling data gaps, dossier preparation as well as chemical safety reports and post submission support.

5 REACH Services Portfolio of Services Our REACH registration and testing services include: Advice on registration and testing/ waiving strategies Literature searches, data evaluation and data gap analysis Technical dossier preparation & submission in IUCLID 5 Member dossier preparation Risk assessments, Chemical Safety Reports (CSR), Higher tier assessments Post submission support Classic and alternative testing: Full testing services (Annex VII to X): Physicochemical Toxicology: Irritation/Corrosion (in vitro/in vivo), Sensitization, Genetic Toxicity (in vitro/in vivo), Acute and Repeated dose toxicity, Developmental and Reproductive Toxicity (DART), Toxicokinetics, Carcinogenicity Ecotoxicology: Aquatic, Terrestric, Biodegradation Environmental Fate and Behaviour Analytical Support REACH SVHC evaluation and testing Alternative testing: Structure activity relationships (QSAR), Grouping and Read-across of tested analogue substances, Categories of related substances, Weightof-evidence and Exposure based waiving

6 Working with Eurofins Eurofins Strong financial position - stability Network of established Eurofins laboratories and partners Experienced regulatory team across Europe Client focused project managers Facilities in Europe and USA Investments in the future: People Ongoing investment in state of the art equipment and IT Continued enhancement of procedures Benefits Long term commitment Being able to offer a one stop shop Ensuring studies meet regulatory requirements Able to manage multisite projects Providing Global Coverage wherever you have your research needs Hiring the best to meet and exceed client expectations Providing a high quality service

7 Eurofins REACH Taskforce BSL BIOSERVICE GmbH Germany Founded in sqm facilities 170 members of staff 62 lab rooms EAS EcoChem GmbH Germany Founded in sqm facilities 144 members of staff 48 lab rooms Eurofins Product Testing A/S Denmark Founded in sqm facilities 60 members of staff Eurofins Regulatory AG Switzerland Founded in sqm offices 33 members of staff Product Safety Labs Inc USA Founded in sqm facilities 70 members of staff 34 lab rooms

8 For further information on how Eurofins can help you with your REACH registration, please contact your local representative. Website: