Registration of Existing Chemicals under REACH
Deadline for pre-registration is approaching

REACH¹ applies to all chemical substances, preparations or articles produced, imported, sold or used in the EU where imported or produced in quantities above one tonne per year (unless an exemption applies).  The first stage of this new EU approach to chemicals is Registration.

Introduction

Manufacturers, importers or those who bring chemicals to market are required to gather information on the properties of their chemical substances, to allow for their safe handling and to register this information on a central database run by the European Chemicals Agency (ECHA)² in Helsinki. The database will be a public database on which consumers and professionals can locate hazard information.
Differing deadlines apply for registering substances depending on whether they are existing non-dangerous substances (called phase-in³ substances) or new (non phase-in) substances.

Pre-Registration

Pre-registration is free and only requires a few pieces of information to be submitted. It can also significantly delay the necessity for full registration (which is a much more complicated and expensive process) of phase-in substances by up to ten years. However, the deadline for pre-registering chemical substances under REACH is 1 December 2008.

If phase-in substances are pre-registered before 1 December 2008 then gradual deadlines for full registration will run from 2010 to 2018 depending on the tonnage and type of substance. Phase-in substances which are not pre-registered before 1 December 2008 (and non-phase-in substances from 1 June 2008) must be withdrawn from the market unless full registration is made straight away.  Thus, if there is any doubt as to whether a substance should be pre-registered, it is wiser to do so.

Pre-registration is made online through the ECHA "REACH-IT" website.  For pre-registration, the following information should be submitted electronically to the ECHA:

• Name of the chemical, including an identifying number (e.g. EINECS number);
• Company name, address and contact information;
• The tonnage band and consequent envisaged deadline for full registration; and
• Information of any structurally similar chemical which may be helpful to provide useful evidence on hazards.

Full Registration

Full registration is a much more detailed process and involves the submission to the ECHA of a registration dossier (which includes a technical dossier and, in some cases, a chemical safety report). In order for a manufacturer/importer to prepare his registration dossier, he will need to communicate with his downstream users, for example, to obtain information about their uses and the risk management measures they have already put in place.

Substance Information Exchange Forums

In January 2009, the ECHA will publish a list of all the substances that have been pre-registered.  Until that time, there is an intermediate list of pre-registered substances available on the ECHA's website.  For each substance, a group comprising all the companies that have pre-registered that substance will be formed. This group, called a Substance Information Exchange Forum ("SIEF") will then share information on the hazards of the chemical so that only one set of technical information has to be submitted to the ECHA.  Membership of a SIEF is beneficial as participants will incur reduced registration fees and can share the costs of preparing a joint registration dossier.

Registration Fees

The registration fee depends on the tonnage registered and is intended to cover the ECHA's costs by reflecting the work involved in registration. Consequently, the greater the tonnage and the more complex the case, the greater the fee will be. All of the criteria/fees are specified in the REACH Fee's Regulation (EC/3401/2008) - available at http://www.hse.gov.uk/reach/resources/feesregulations.pdf.

In addition, a tool, called the Navigator, has been developed to help users identify their obligations under REACH. It can be found on http://echa.europa.eu/reach_en.html.

Contact

If you would like further information on REACH, pre-registration, registration or the enforcement of REACH by the HSE, please contact:

¹ Registration, Evaluation and Authorisation of Chemicals Regulation 1907/2006 ("REACH") is an EU Regulation which came into force on 1 June 2007. REACH deals with the Registration, Evaluation, Authorisation and Restriction of Chemical substances.
² The ECHA will act as the central point in the REACH system. The Health and Safety Executive (HSE) is the UK REACH competent authority but it will work closely with the Environment Agency and SEPA in the management of certain areas of REACH's application.
³ Phase-in substances are those which were already being manufactured or placed on the market before the entry into force of REACH on 1 June 2007, were not notified according to the Dangerous Substances Directive and meet several criteria (such as listing in the European Inventory of Existing Commercial Chemical Substances).

© 2008 McGrigors LLP . All rights reserved. The information contained herein is of a general nature and is not intended to address the circumstances of any particular individual or entity. Although we endeavour to provide accurate and timely information, there can be no guarantee that such information is accurate as of the date it is received or that it will continue to be accurate in the future. No one should act on such information without appropriate professional advice after a thorough examination of the particular situation. Neither this nor any other communication is intended to be, or should be construed as, an invitation or inducement (direct or indirect) to any person to engage in investment activity. McGrigors is regulated by the Law Society of Scotland. McGrigors London is regulated by the Law Society of England and Wales.