Originally published in BLG's Environment and Health & Safety Digest, Autumn 2007

The modern world depends on chemicals.  Global chemical production has grown enormously within the space of a few decades, from one million tonnes in 1930 to over 400 million tonnes today. 

Not all chemical properties are beneficial.  To minimise risks to human health and the environment, it is important that any dangerous properties exhibited by chemicals are identified at an early stage and appropriate controls placed on their manufacture, import and use.

The EU regulatory system developed over the years to identify and manage problematic chemicals has been widely criticised.  In particular, although reasonably effective in evaluating "new" substances put on the market since 1981, "existing" substances marketed before that date have largely escaped scrutiny.  The result is that many tens of thousands of chemicals continue to be used without a proper investigation or evaluation of associated risks ever having been conducted.

The system has now been completely revamped by "REACH", the EC Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals.  REACH came into force on 1 June 2007 and is managed through the European Chemicals Agency, an entirely new body based in Helsinki, supported in the UK by the HSE.

REACH is particularly aimed at the thorough regulation of an extremely wide range of existing, as well as new, chemical substances. 

EU manufacturers and importers of chemicals and chemical preparations bear the heaviest responsibilities under REACH.  After 1 June 2008, where a manufacturer or importer wishes to manufacture or import a chemical (either on its own or in one or more preparations) in quantities of one tonne or more per year, it must register with the Agency.   There are registration requirements on the producers and importers of chemical-containing articles also.

Registration can be a complex process involving the lodging of carefully prepared documentation on the relevant chemical, the risks that it presents and the ways that the risks can be mitigated, backed up by testing results and other evidence.   

In order that the Agency is not immediately bombarded on 1 June 2008 with tens of thousands of registrations in respect of chemicals, preparations and articles that are already being, and must continue to be, manufactured, imported or produced, REACH provides for the gradual registration of so called "phase-in substances" over an 11 year period. 

Once registered, substances, preparations and articles can be (or, in the case of phase-in substances, can continue to be) manufactured or imported.  In addition, as long as the use is consistent with the registration, downstream users can use (or continue to use) them.  Over time, the Agency evaluates all registrations to ensure that they are sound. Evaluation may lead the Agency to the conclusion that there are dangers associated with a chemical and that action needs to be taken under REACH's "restriction" or "authorization" procedures to control them.

Failure to comply with REACH carries criminal sanctions.  Defra has just consulted on the criminal sanctions that will apply in the UK.

REACH will have a positive effect on chemical safety.  However, manufacturers, importers and users, together with their insurers, should note:

  • The total cost to chemical manufacturers, importers and users of compliance with REACH over the next 11 years is estimated at between €2.8 billion and €5.2 billion.

  • The sheer number of substances now being tested for the first time may mean that there will be some nasty surprises.  If some widely distributed substances are found to be causing health or environmental problems that were formerly not widely appreciated, liability for manufacturers, importers or users of the substances could result and expensive product redesign could be required.

This article first appeared in Insurance Day and is reproduced with the kind permission of Informa

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.