60 Second Guide - REACH

The Registration, Evaluation, Authorisation (and restriction) of CHemicals, or REACH regulations were adopted in December 2006, and came into force across European Union (EU) Member States on June 1st 2007.

The chemicals sector is the third largest manufacturing industry in the EU, encompassing 31,000 companies and some 1.9 million people. Internationally, the EU is a leading chemicals producer representing around a third of global sales. REACH will have the biggest impact on the industry for 25 years.

Only once, in 1981, were all chemicals documented in the EU, in total 100,106 of them. However, of the 30,000 most frequently used chemicals only 3% had been fully tested, with 21% of them having no safety data and a further 65% inadequate data.

At the same time the European Commission (EC) estimates that 1% of all diseases in Europe are attributed to chemicals.

Once fully implemented, between years 10 and 30, it is anticipated that REACH will eliminate 4,500 cases of cancer each year and there will be 90,000 fewer allergies.

However, the cost to industry of REACH implementation is estimated at between €2.8 billion and €5.2 billion.

So what are the REACH regulations?

REACH is all about registering those 30,000 chemicals and any new ones released after the 1981 census. Within scope of the regulations are substances (chemicals), preparations which are mixtures of substances such as paints, adhesives and sealants and finally articles (products) where a chemical is released.

All of these must be registered with the appropriate level of safety data based on the tonnage manufactured or imported into the EU.

More than 1000 tonnes per annum should be registered by 30th November 2010, 100 to1000 tonnes by 31st May 2013 and 1 to 100 tonnes per annum by 31st May 2018.

If a pre-registration window that is open until the end of November is missed then substances cannot be imported or sold until fully registered, and the safety data and risk assessments could take many months to prepare.

Substances of Very High Concern or SVHCs are the most hazardous chemicals and can be toxic, carcinogenic, mutagenic, reproductive toxins and harmful to the environment. These may need to be “authorised” for use and such authorisation will not be given if there are safer alternatives, or if the substance cannot be safely controlled.

In October 2008, the European Chemicals Agency (ECHA) based in Helsinki, announced the first batch of SVHCs. These will be updated periodically and bring with them a number of requirements. If there is an SVHC in an article at a level of 0.1% by weight, or more, of the product then this needs to be communicated to users. The web can be used but not the web alone, and should be supported by another pro-active method such as paper at the point of despatch. Details of “safe use” must be supplied where appropriate, for example a pregnant woman should not be exposed to frequent handling of substances that contain reproductive toxins.

Material Safety Data Sheets (MSDS) are required when a substance or preparation (but not articles) are supplied to any user in the EU where certain criteria are met. This would include dangerous substances as classified by the Dangerous Substances Directive, persistent, bioaccumulative or toxic substances or those deemed as of very high concern.

The costs of registration are significant and depend on the tonnage and size of company. Standard fees range from €1,600 to €31,000 for registration while authorisation of use costs start at €50,000.

Clearly, some manufacturers will prefer to discontinue a product rather than put it through the REACH process. As a result, the EC estimate that 2% of all substances will be made obsolete.

So, in summary, REACH will save lives but at a significant cost to industry. Short term, there will be a huge data collection exercise from manufacturers as, in the case of SVHCs, there will be an obligation to pass this information on to users.

For further information refer to the Farnell REACH Step-by-Step Guide version 5 and supporting Substances in Articles pdf at www.global-legislation.com

Questions on legislative matters can be posted at glegislation@premierfarnell.com