REACH - The NEW EU CHEMICALS STRATEGY: a new approach to chemicals management

In 1998 it was decided that the EU chemicals regulatory system needed reform. A long process of analysis and discussion resulted in a proposal for a new system, called REACH - Registration, Evaluation and Authorisation of CHemicals.

REACH is the first regulatory system for chemicals that will actually remove the distinction between older ('existing') chemicals and 'new' ones. It also includes new mechanisms for identifying appropriate risk management measures for controlling chemical use and requirements for communicating information on chemical properties, and safe uses up and down the supply chain.

The REACH regulation has now been adopted and came into force in June 2007 paving the4 way for setting up the European Chemicals Agency (EChA) in Helsinki Finland. The EChA is a key organization that will manage the REACH process and coordinate the activities of the Member States who have had to appoint competent authorities to provide information, assist in the administration, and enforce the provisions of the regulation.

The new system will have an impact on many goods and commodities imported into the EU. US exporters currently export some $186 billion in goods to the EU. For more on US exports, see this report on state exports to the European Union by sector, or visit the US Department of Commerce database of exports.

What is REACH?

REACH is designed to be an integrated approach to the control of the production, import and use of chemicals in Europe. It aims to create a system which is based on information about chemicals, and which ensures that useful safety information gets to those using chemicals. The REACH system is quite complex, though so are the network of 40 or so regulations that it is replacing.

Crucially, in REACH the main responsibility for chemical safety is clearly placed on the chemical producer or importer (into the EU), not on public authorities or downstream users.

REACH can be thought of as fulfilling two key roles:

It describes the phased process to overcome the lack of data on existing chemicals (sometimes referred to as the ‘burden of the past’) – including a series of deadlines, based on tonnage, for registering information on existing chemicals. This should mean that information on all existing substances manufactured in, or imported into, the EU in tonnages of 1 tonne or more per year should be available within 11 years of REACH entering into force.
It lays out the regulatory system for the management of chemicals in the EU. For example, information requirements for all ‘new’ substances, the system for the control of substances of very high concern, and the information that should pass both up and down the supply chain.

Note: LCSP have also produced a free briefing which explains REACH in more detail, and see the base of the page for more detailed sources of information.

Further reading on the importance of REACH can be found here.

What follows is a very brief summary of the key components of the REACH regulation:

Registration

Registration is the process under which chemical substance manufacturers and importers (into the EU) will be obliged to send a registration dossier containing safety data to a central European Chemicals Agency on substances produced or imported in quantities of one tonne per year or more.

Manufacturers and importers of 10 tonnes or more per year of a substance must also submit a chemical safety report (CSR), in which they must detail the hazard and risk assessment of the substance for specified (‘identified’) uses and how the risks posed by the chemical can be 'adequately controlled' for these uses. One of the outputs of the assessment is an ‘exposure scenario’; this is a summary of the use(s) and appropriate risk management measures which is communicated to downstream users as an Annex to the (material) safety data sheet (SDS).

Registration includes a phase-in periods of 3, 6 and 11 years according to the tonnage manufactured or imported in order to collect this information for ‘existing’substances.

Evaluation

Evaluation is a process by which registration dossiers can be examined. It may result in a request for further information on substances from the registrant. There are two types of evaluation with different aims:

Dossier evaluation (i.e. per individual registration):

Checking of testing proposals to prevent unnecessary animal testing, i.e. the repetition of existing tests, and poor quality or unnecessary tests. The Agency will be responsible for checking the testing proposals under annexes VII and VIII submitted as part of the registrations before the tests are performed;
Compliance check: The Agency will check the compliance of, a minimum of 5%, registration dossiers with the registration requirements. National enforcement action is possible as a result.

Substance evaluation (i.e. per substance):

The Agency, in conjunction with MS Authorities, may clarify suspicions of risks to human health or the environment by requesting further information from industry on particular substances. Any costs incurred should be shared amongst registrants of the substance. Substance evaluation will be prioritized on the basis of risk following guidance to be developed by the Agency.

Evaluation may lead to the conclusion that action needs to be taken under the restrictions or authorisation procedures, or that information needs to be passed on to other authorities responsible for other relevant legislation. The evaluation process should ensure that reliable and useful data is provided and made available to the relevant bodies by the Agency.

Authorisation

For substances of very high concern (SVHC), an authorisation is required for their use and their placing on the market. The substances required to be authorized are substances that:

are carcinogenic, mutagenic or toxic for reproduction (CMRs) category 1 and 2
are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative (PBTs/vPvBs) according to given criteria, and/or
give rise to an ‘equivalent level of concern’ to those mentioned above where there is scientific evidence of probable serious effects to humans or the environment (e.g. endocrine disruptors) which will be identified on a case-by-case basis.

These substances are considered to have hazardous properties of such high concern that it is necessary to regulate them centrally through a mechanism that ensures that the risks related to their actual uses are assessed, considered and then decided upon on an EU-wide basis. The justification is that the effects on humans and the environment of these substances are very serious and normally irreversible. Substances that fall into these categories will be fed into the authorisation system as resources allow. Their uses will not be banned by default.

An authorisation can be based solely on ‘adequate control’ (demonstrated in the CSR) of the substance for the use in question. However, ‘adequate control’ cannot apply to PBTs, vPvPs and non threshold CMRs as it is not possible to determine a ‘safe’ exposure. All applications for an authorisation must be accompanied by an analysis of possible alternatives considering their risks and the technical and economic feasibility of substitution. All authorizations will be subject to a time-limited review. This would enable further consideration of the availability of alternatives at some point in the future.

Restrictions

Chemicals whose use poses “unacceptable risks” to human health or the environment and need to be managed on an EU-wide basis may have production or specific uses legally restricted through this process.

Agency

A new European Chemicals Agency has started its work. This agency will coordinate much of the regulatory work in REACH, though EU Member States will still have considerable responsibility. The Agency will also have primary responsibility for the evaluation process.

Classification and Labeling

REACH creates a new inventory of classification and labeling of chemicals; industry must submit the classification and labeling of all substances subject to registration or placed on the EU market to a central, public database.

The EU Commission has introduced a proposal for regulation on GHS that will implement GHS at the same time as REACH. See the GHS page for more details.

Information Flow

Much, though not all, of the information generated by REACH will be publicly available, including the main database of substances and properties and the classification and labeling database.

Latest News on REACH

REACH is a major reform of chemicals management legislation in Europe an although the legal text has been published, further interpretation of the legal text and guidance on practical application is being developed. Stakeholders including NGOs are involved in the management aspects of the European Chemicals Agency and many decision making committees have been set up to make the REACH process as transparent as possible.

Sources of More Detailed Information on the REACH Proposal

The Lowell Center for Sustainable Production has produced a free briefing which explains REACH in more detail.
See our News and Events page for relevant briefings.
The Publications page has a number of other Lowell Center publications on REACH.
Presentations, and educational materials are available on the Educational Materials page.
More detailed information and guidance is available from the European Commission DG Environment REACH web site and the DG Enterprise REACH web site.
The REACH text itself
The Agency EChA provides useful information and guidance (including the Navigator tool and the outcome of the REACH Implementation Projects (RIPs))
The European Chemicals Bureau also provides information and much of the development of guidance that has started here will migrate to the EChA site when it is finalized.
A list of guidance documents is available here.