Welcome to Steptoe's REACH Resource Centre, a website specifically designed to assist you in navigating this complex legislation from start to finish.

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REACH Resource Centre

Are you REACH compliant today and prepared to comply through to 2018?

Our integrated team of lawyers, scientists and technical consultants applies an unrivalled depth of understanding to the practical and strategic challenges of REACH. This REACH Resources Centre provides access to a range of materials explaining the intricacies and evolution of REACH. Please navigate to relevant material using links to information below and via the left-hand sidebar of this page. If you do not find what you are looking for or wish to discuss your issue further, please contact a member of our REACH team at REACH@steptoe.com or +32 2 626 0572.

REACH affects all substances on their own, in mixtures (preparations) and in articles. It covers substances manufactured in or placed on the European Economic Area (EEA) market (the 27 EU member states plus Iceland, Liechtenstein and Norway). Even substances in small quantities (under the one metric tonne threshold for compulsory registration) may be subject to obligations under REACH, including those concerning restrictions, authorisation and safety data sheets (SDS).

The broad scope affects all actors in the supply chain—not only chemical companies. Substance producers, importers, formulators and exporters to the EEA have REACH obligations. REACH also applies to manufacturers of semi-finished and finished products. REACH has transferred responsibility and costs for data generation on chemical safety to industry and strict time limits must be respected in order to maintain market access.

Steptoe helps its clients understand and comply with all aspects of the REACH Regulation (EC) 1907/2006 (concerning Registration, Evaluation, Authorisation and Restriction of Chemicals). Cost-effective compliance strategies draw on:

our conventional role as legal counsel:
- resolving complex interpretative issues, gaps and contradictions in the regulatory framework;
- legal drafting supporting all stages of REACH compliance, including tailor-made agreements for consortia, Substance Information Exchange Fora (SIEFs), confidentiality protection, data licensing, cost-sharing, lead registrant obligations and contracts with research organizations, suppliers and downstream customers; and
- navigating the interrelationship with the many horizontal and sectoral regimes, including those on classification, labelling and packaging of substances and mixtures (CLP), biocides, cosmetics, food contact materials, medical devices and plant protection products.
experience acting as:
- “only representative” registrant for companies established outside the 30 EEA states;
- “third party representative” for companies established in the 30 EEA states, protecting their identities from competitors by representing them in SIEFs and thereby protecting commercially sensitive confidential business information (CBI); and
- independent trustee to SIEFs and consortia, receiving, analysing and aggregating commercially sensitive information to avoid disclosure of CBI and breaches of EU competition/antitrust law by competitors.

Our REACH team has decades of experience assisting companies in the international chemicals and related industries with EU regulatory matters. We have spent many years forming, participating in and running chemicals consortia (task forces) established for data sharing and/or joint dossier submissions to obtain regulatory approvals.

Registration & Evaluation

REACH forces competitors to share data and cooperate, including by means of a joint submission for much of the registration dossier. It also mandates sharing of studies involving vertebrate animal tests. All parties sharing data need to ensure that they receive fair compensation. We have a wealth of experience on the key issues of (1) data valuation and compensation, including facilitating agreements among companies obliged to share data; and (2) managing the competition law/antitrust risks which arise when companies cooperate.

The ‘no data, no market’ principle, at the heart of REACH, means that those required to pre-register phase-in (EINECS) substances by 1 December 2008 who failed to do so are now banned from the market. Those companies that did pre-register currently benefit from extended registration deadlines, phased-in according to hazard classification and volumes manufactured/imported. Late pre-registration is available only in limited circumstances.

For new ELINCS substances, subject to a proprietary notification under Directive 67/548/EEC, which are not phase-in substances, REACH provides for a detailed ”inquiry” procedure. We are helping a number of clients to navigate this distinct approach to registration where, for example, SIEF rules on data sharing and compensation do not apply.

Many companies require support to meet the demands of future registration deadlines. The first registration deadline, which was 30 November 2010, applied to companies with substances in quantities ≥ 1,000 tonnes or certain CMRs/toxic substances. The next registration deadlines are 31 May 2013 for phase-in substances in quantities between 100 and 1,000 tonnes per year and 31 May 2018 for annual quantities from 1 to 100 tonnes.

Our REACH Registration work focuses on four principal areas:

building and executing REACH compliance programmes, including managing the impact on business operations;
monitoring and representing registrants in SIEF and consortia (including consortium management);
managing the full range of data sharing and compensation issues, including compiling an internal inventory of “own” data, confirming ownership documentation, assessing and valuing data, and obtaining and defending data waivers or establishing read across for specific end points; and
preparing and submitting registration dossiers.

Appeals

The European Chemicals Agency (ECHA) has wide decision-making powers that affect your rights and obligations. Steptoe helps clients navigate the complex appeals procedures. If you are an appellant or intervener, be aware of the short deadlines for action. Immediate work needs to begin as soon as you are aware of a problem. To learn more about the opportunities to appeal to ECHA’s Board of Appeal (BoA) and the General Court, please click here.

Authorisation

Steptoe helps clients to navigate the complex Authorisation procedures. Authorisation is designed to ensure that risks from Substances of Very High Concern (SVHCs) are properly controlled. SVHCs will be progressively replaced by alternative substances or technologies. Companies can only use or place Annex XIV substances on the market when they have received an authorisation.

Steptoe has helped clients defend their core substances under a wide range of chemical regimes through years of constructive interaction with policy makers in Europe and the United States. Working closely with our clients, we prevent the adoption of unwarranted substance restrictions and product de-selection by providing creative solutions to real and perceived difficulties. We can be most effective when engaged to assist clients with their product advocacy long before a core substance is placed on the ECHA Registry of Intentions or the Candidate List. To learn more about the authorisation procedures, please click here.

Enforcement

National inspection authorities enforce REACH. The penalties can be criminal and/or administrative:

fines (EUR 5,000 to 55,000);
injunctions (including market withdrawal); and/or
prison sentences (1 month to 25 years).

National authorities, including customs officials, have wide search, sampling and seizure powers. To learn more about how to prepare for enforcement and engage with national authorities, please click here.

Recent Seminars & Events

Our REACH team participates in a wide range of seminars and events. Click here to view our recent and upcoming REACH events.

News

Publications

EU Analyst: Environment & Life Sciences
July 30, 2010
EU Analyst: Environment & Life Sciences
April 15, 2010
Nanotechnology in the EU Cosmetics Regulation
2009, Household and Personal Care Today
REACH: Polymer-Specific Issues
August 7, 2009, Plastics News