Rules change for chemicals

European legislation concerning chemicals does not just affect manufacturers, says Ian Lightfoot, senior consultant at CRA (Europe). And failure to register for REACH by the deadline could have serious implications

REACH is a European Union regulation concerning the Registration, Evaluation, Authorisation and restriction of Chemicals (Regulation (EC) No 1907/2006). It came into force on 1 June 2007 and replaced a number of European Directives and Regulations with a single system. It covers the majority of chemicals manufactured, imported or exported from the EU.

The aim of the regulation is to provide a high level of protection to both human health and the environment by making the manufacturers, importers or suppliers of chemicals responsible for managing potential risks associated with their products. The regulation covers a wide spectrum of chemicals but it does not cover radioactive substances, biocides, cosmetics and medical products, which are covered under alternative EU legislation.

A number of other chemicals and substances whose toxicological properties are well defined are also exempt; such as minerals, some gases (including oxygen and hydrogen) and substances that occur in nature, such as oil and coal. Therefore, if a company manufactures, imports or uses individual chemicals, mixtures of chemicals, or has a non-exempt chemical in any of their products, they may have obligations under the REACH Directive.

One important aspect of REACH that can be overlooked applies to chemical intermediates. An intermediate is defined under REACH as “a substance that is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance (hereinafter referred to as synthesis)”.

Should an on-site manufactured intermediate be produced and consumed without leaving the manufacturers premises it may require registration under REACH. In essence even though a company is not necessarily selling a finished product, it does not necessarily mean they have no obligations to register or notify a product under REACH.

Business impacts

If a company obtains materials from EU suppliers, they should inform the supplier what the material is used for. It should be noted that, if your supplier fails to register, then it is possible that you will be unable to obtain products from them until they have registered. This can potentially impact on business.

If a company uses less than one metric tonne of a particular chemical, then it may be exempt from the regulation. But, if your product contains a substance of very high concern (SVHC), you may still have obligations under the REACH Regulation irrespective of the one-tonne limit.

SVHCs are substances that are carcinogenic, mutagenic or toxic to reproduction or persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB). At present, there are 16 substances on the candidate list. But this is likely to increase significantly over the coming years as potential risks are identified resulting in a number of chemicals being reclassified as SVHC.

Once a company has determined that it is required to register under REACH, then a decision needs to be made over whether to pre-register or undergo full registration for each chemical identified. Both pre-registration and registration are managed online by the European Chemicals Agency (ECHA).

For pre-registration, a company would be required to enter a limited number of fields including the company’s details, contact information, chemical information, tonnage, potential exposure pathways and chemicals uses. Pre-registration must be completed prior to 30 November 2008 in order to gain the advantage of not having to fully register.

Full registration is significantly more complicated and will involve providing detailed exposure and toxicological data to the ECHA. Failure to pre-register and not having the correct data for full registration will mean a company will not be able to manufacture, sell within the EU or export products to non-EU countries.

By pre-registering, the final date for full registration is put back depending on the tonnage of each chemical used. For more than 1,000 tonnes a year, full registration is 2010. For less than 1,000 but more than 100 tonnes a year, full registration is 2013. And for less than 100 tonnes a year, full registration is 2018.

Once registered, a company is put in a Substance Information Exchange Forum (SIEF) with other companies that manufacture or use the same chemical. These forums will allow the exchange of data and if necessary the commissioning of additional testing to fulfil the requirements for REACH.

Divided cost

It is proposed that the cost of obtaining the necessary data for full registration will be divided among the SIEF members. Should a SIEF member already possess sufficient data, it is possible that this information can be sold on to the other members of the SIEF, immediately allowing registration to be completed.

If a UK company is unsure of whether REACH applies, it is advised that clarification is achieved via the Health & Safety Executive (HSE). The HSE advises that pre-registration should be undertaken if a company is in any way unsure of its REACH obligations thereby benefiting from extended registration. Checking critical suppliers is also imperative to ensure that a continuation of supply post November 2008.

So, to summarise, yes REACH does apply to manufacturers of chemicals. But it is possible that more companies have obligations under REACH. Failure to comply by the pre-registration deadline may be extremely costly and could result in a company being unable to manufacture, sell or use a number of its products.

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