REACH

Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006

What is REACH?

REACH is a European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of CHemicals. The legislation entered into force on 1st June 2007 to streamline and improve the former legislative framework on chemicals of the European Union (EU). The key aim of its implementation is to protect human health and the environment from the risks arising from the use of chemicals.

Under REACH, the responsibility for demonstrating the safe use of chemical substances will be transferred from regulators to industry. All manufacturers and importers of substances in quantities higher than 1 tonne per year will be responsible for assessing and managing risks and providing appropriate safety information to their users. A major part of REACH is the requirement for manufacturers / importers to register their substances with a central European Chemicals Agency (ECHA). 

The ECHA located in Helsinki, Finland has a central co-ordination and implementation role in the overall process. It will manage the technical, scientific and administrative aspects of the REACH system to ensure consistency across the European Union.

Scope and Exemptions

It is estimated that currently about 30.000 substances are in the EU market in volumes above one tonne. Generally, REACH applies to all individual chemical substances on their own, in preparations or in articles (if the substance is intended to be released during normal and reasonably foreseeable conditions of use from an article).

All substances are covered by the regulation unless they are explicitly exempted from its scope. More information on exemptions can be found on the ECHA website.

The Key Components:  

·      Pre-REGISTRATION

Manufacturers and importers must pre-register substances that are already on the EU market (phase-in substances) if they want to benefit from transitional arrangements that allow registering them at a later stage. Pre-registration also enables registrants to share data with other registrants and avoid carrying out redundant tests. The pre-registration period is limited from 1 June 2008 to 1 December 2008.

A list of all pre-registered substances will be published on the ECHA website by 1 January 2009. This list will facilitate the identification of potential registrants of the same substance for the purpose of data sharing.

Joint registration and data sharing

This is the principle that for any one substance, a single set of information on its intrinsic properties is produced that is shared by all those companies that manufacture or supply that substance. Business specific (e.g. company name) and business sensitive (e.g. how it is used) information is submitted separately by each company. The Companies will work together to get an agreement on information sharing through a Substance Information Exchange Forum (SIEF), the details of how this information is shared is the responsibility of the businesses involved. Companies who submit joint registrations via a SIEF benefit from a reduced registration fee.

If a manufacturer or importer fails to pre-register a phase-in substance, he will need to register it before continuing manufacture or import. Pre-registration is not a legal requirement of REACH but is strongly advised.

·        REGISTRATION

REACH requires manufacturers and importers of chemical substances (=1 tonne/year) to obtain information on the physicochemical, health and environmental properties of their substances and use it to determine how these substances can be used safely. This information and its assessment are to be submitted to the ECHA. Further information on registration can be found on the ECHA website.

·         EVALUATION

The Agency will perform dossier evaluation to assess testing proposals made by the registrant or to check that the registration dossiers comply with the requirements. The ECHA also co-ordinate substance evaluation, which will be conducted by the Member States to investigate chemicals of concern.

·         AUTHORISATION

Substances of very high concern will be gradually included in Annex XIV of the REACH Regulation. In order to place on the market or use such prioritised substances, industry must apply for an authorisation. The ECHA will publish a list containing substances to be considered for the authorisation process by 1^st June 2009. Decisions on authorisation are made by the European Commission.

Applicants will have to demonstrate that risks associated with uses of these substances are adequately controlled or that the socio-economic benefits of their use outweigh the risks. Applicants will also have to investigate the possibility of substituting theses substances with safer alternatives or technologies, and prepare substitution plans, if appropriate.

Substances of Very High Concern

Some substances have hazards that have serious consequences, e.g. carcinogenic (cancer causing), or they have other harmful properties and remain in the environment for a long time (persistent) and/or gradually build up in animals (bio-accumulative). These are 'substances of high concern'. This category also includes substances demonstrated to be of equivalent concern, such as “endocrine disruptors”. One of the aims of REACH is to control the use of such substances via authorisation and encourage industry to substitute these substances for safer ones, if possible.

·         RESTRICTIONS

The European Union can impose restrictions and prohibit or set conditions for the manufacture, placing on the market or use of certain dangerous substances or group of substances when unacceptable risks to humans or the environment have been identified. Restrictions of a substance can apply to all uses or to specific uses and there is no tonnage threshold for a substance to be subject to restriction. 

Communication in the supply chain

The passage of information up (upstream) and down (downstream) the supply chain is a key feature of REACH. REACH adopts and builds on the previous system for passing information. Suppliers of substances must pass on information on the health, safety and environmental properties and safe use of their chemicals to their downstream users (via a Safety Data Sheet). The manufacturer, importer or downstream user will prepare the SDS according to a similar principle as he did before REACH came into force. The main difference is that when required, the SDS will also have an annex including exposure scenarios specifying the conditions under which the substance or preparation can be used safely, for uses that have been identified. In order for suppliers to be able to assess the risks posed by the use of these substances they need information from downstream users. REACH provides a framework in which information can be passed both up and down supply chains.

If an SDS is not required, the supplier still has to communicate key risk information about the substance, in particular stating if the substance is subject to authorisation or restriction, together with any other available and relevant information to enable appropriate risk management.

Enforcement

Enforcement of REACH towards companies is a task for the individual Member States. In the UK, the Competent Authority is hosted by the Health and Safety Executive, working with the Environment Agency and other government departments.

Further information and help is available to all BPF members by logging onto the
BPF REACH toolbox