Coming into force in 2007, with staggered deadlines depending on tonnage and hazard class through to 2018, the regulation covers all substances manufactured in or imported into the EU in tonnages of 1 tonne per year or more.

The first major REACH registration deadline was 30th November 2010. wca environment has worked for a number of clients across a variety of industries to meet this deadline, and has been involved in nearly 400 successful registrations.

wca environment, building upon its successful 2010 registrations and considerable expertise working under previous regulatory regimes, is well placed to assist companies in all aspects of REACH registration for both 2013 and 2018 deadlines. We have considerable experience with all aspects of REACH, including initial data review and assessment, through to IUCLID5 file preparation/hosting and final registration. Specific tasks with which wca environment can help you business to undertake include:

Technical information searches

• Data review and assessment, including robust summary preparation
• IUCLID 5 dossier preparation and secure IUCLID software hosting for consortia and SIEFs
• Substance identity and physical chemical properties
• Classification and labelling (including CLP/GHS)
• Data gap analysis and design of Integrated Testing Strategies
• Human health hazard assessment of physicochemical properties
• Human health hazard assessment and toxicology study commissioning/management

Environmental hazard assessment and environmental fate/ecotoxicology study commissioning management

• PBT and vPvB assessment
• Environmental exposure assessment/modelling
• Risk characterisation
• CSA/CSR production

Assistance with dossier submission via REACH-IT

A particular area of expertise is in the field of risk assessment and characterisation. wca environment scientists have had extensive involvement in the derivation of predicted no effect concentrations (PNECs) and limit values for substances in water, soils, sediments and waste, and in producing hazard and exposure assessment for chemicals. In addition, we have successfully developed bespoke monitoring programmes to reduce uncertainty in exposure calculations. Our expertise is directly relevant to the complex activities involved in preparing Chemical Safety Assessments (and Exposure Scenarios) required for substance registration under REACH. See details of our REACH Compliance Programme or download our REACH Services Brochure.

wca environment are also able to provide assistance for the later stages of REACH. Please see our page on Socioeconomic analyses.

As well as preparing Classification and Labelling Proposals as part of REACH projects we can also assist clients in preparing their CLP notifications for substances with later REACH registration deadlines, or which do not fall under REACH.

wca environment’s REACH Compliance Programme

The key to successful Registration of substances under REACH lies in logical step-wise progression through the entire process. Most aspects of REACH are interlinked and the omission of a key aspect in the early stages could jeopardise a successful Registration.

wca environment has developed a 5-phase programme that covers the entire substance Registration process. While we are currently undertaking the full programme for a number of clients, one or more of the modules can be chosen individually, where a particular resource or expertise is needed by a client.

Phase I: Literature Review & Data Gap Analysis

Publicly available and client data are reviewed. The output from this phase is a data matrix which identifies endpoints where there are either no data, valid data exist, or other relevant toxicity data are available (e.g. QSAR and Read-Across). Where necessary, substance groups or categories can also be proposed.

Phase II: Test Programme Derogation

Relevant data from Phase I are scored for quality (Klimisch scores) and the data gap analysis is completed. The potential for test derogation and read-across between grouped substances is considered and reported in detail.

Phase III: Test Programme Design

A test programme is designed, based on derogations from Phase II, comprising the minimum number of tests to establish valid endpoint data. For substance categories we design a programme to maximise the read-across potential. We have the expertise to initiate and monitor the physico-chemical, toxicity, ecotoxicity and environmental studies in appropriate GLP-accredited Contract Research Organisations on behalf of a client.

Phase IV: Chemical Safety Assessment & Report

A Chemical Safety Report (CSR) detailing the results of a Chemical Safety Assessment (CSA) must be submitted with the Registration dossier for substances manufactured/imported above 10 tonnes per annum. Any CSA/CSR undertaken by wca environment complies with the format and content detailed in Annex 1 of the REACH regulations. It includes the relevant Exposure Scenarios developed for the use of the substance(s) together with the substance CLP/GHS classification.

Phase V: IUCLID File Compilation & Registration Dossiers

All submission to ECHA must be electronic, using the latest IUCLID file format. We populate the relevant sections of the file with the data either provided to us or generated during the course of the Phases III/IV. This also includes, where necessary, and proposals for further relevant testing. For Consortia in particular, we are able to host IUCLID 5 files on our secure server for ease of access by member companies.

• Higher Olefins and Poly Alpha Olefins (HOPA) REACH registration project
• Review of PBT, vPvB and equivalent concern REACH criteria for over 500 substances
• Pre-SIEF assessment of >1000 tonne pa substance
• Lead consultants for Rhenium and Platinum Group Metals (PGMs) for Precious Metals Consortium (www.epmf.be)
• Environmental consultants for Lower Olefins and Aromatics Consortium (www.loa-reach.com)
• Environmental consultants for Acetyls Sector Group (ASG) Consortium
• Strategic advice to importers of substances, preparations and articles.
• Advice to Malaysian government on development of a chemicals notification scheme that compliant with REACH and GHS
• Environmental Consultants for Pentanes for the Hydrocarbon Solvents Producers Association (HSPA) REACH Consortium