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Extending EU regulations with REACH
By John F. Mason, Contributing Editor -- Electronic News, 4/24/2007
Despite the hassle many electronic companies went through, and are still going through, to find alternative substances to replace materials forbidden by the European Union Commission’s Restriction of Hazardous Substances directive (RoHS), a new challenge will soon appear: the EU’s Registration, Evaluation and Authorization of Chemicals (REACH), a regulation that will control the use of tens of thousands of chemicals, many of which are used in the electronics supply chain.
REACH, like RoHS, aims to make the environment cleaner and stop endangering manufacturers’ personnel and users of their equipment. Unlike RoHS, which focuses on hazardous materials, REACH focuses on hazardous chemicals.
Though REACH will come as a surprise to some when it begins to come into effect this June, the directive has actually been in the works since 1998, and impacts not just electronics -- which is the focus of this report -- but a long list of other industries. In 1981, the only time such a study was made, chemical production was the third largest manufacturing industry in the EU, with 31,000 companies, chalking up 580 billion Euros ($787 billion) annually in global sales. At that time, 106 chemicals were reported on the European market. For 99 percent of these, information on properties was sketchy, although chemicals produced in volumes exceeding 1,000 tons a year have been examined more closely. For about 21 percent of these, there is still no data, and for another 65 percent, the information is insufficient.
During the creation of this directive, the Commission asked many stakeholders to respond to questions to help with the directive and to assure its cost-effectiveness and received 6,000 replies. The final text of the new directive was adopted in December 2006 and was published in the organization's Official Journal on December 18, 2006.
REACH will become law on June 1, 2007, just 11 months after RoHS took affect, and has been called “RoHS on steroids” because, as the regulation determines, components may have to be revamped to avoid the inclusion of hazardous chemicals not addressed by RoHS.
Managed by the Commission’s newly created EU Chemicals Agency, now being set up in Helsinki, Finland, REACH requires the registration, evaluation, authorization and restriction of tens of thousands of chemicals, much like RoHS required for hazardous materials, although on a smaller scale. Enterprises that manufacture or import more than one ton of a chemical substance per year will be required to register it in a central database administered by the EU Chemicals Agency. The registrants must also identify appropriate risk management measures and communicate them to the users.
“The new regulation will improve the protection of human health and the environment while maintaining competitiveness, and enhancing the innovative capability of the EU chemicals industry,” said a Commission spokesman.
The REACH regulation relates mainly to the following EU legislation:
-Directive on the Classification, Packaging and Labeling of Dangerous Substances
-Directive on the Classification, Packaging and Labeling of Dangerous Preparations
-Regulation on the Evaluation and Control of the Risks of Existing Substances
-Directive on Restrictions on the Marketing and Use of certain Dangerous Substances and Preparations
“REACH is a radical step forward in EU directives, giving greater responsibility to industry to manage the risks from chemicals and to provide safety information to be passed down the supply chain,” the Commission spokesman continued.
Unlike RoHS, however, REACH’s presence will not be immediately felt when its first in-force date rolls around in less than six weeks. In fact, REACH requires registration over a period of 11 years of some 30,000 chemical substances. (See below chart.)
Timeline for the implementation of REACH
| June 1, 2007 | REACH goes into effect. |
| June 1, 2008 | European Chemicals Agency in Helsinki becomes operational |
| June 1 to Dec. 1, 2008 | Pre-registration of phase-in substances |
| Nov. 30, 2010 | Registration deadline for substances in quantities of 1,000 tons and above, as well as carcinogens, mutagens and substances toxic to reproduction above 1 ton per year and substances classified as very toxic to aquatic organisms above 100 tons |
| May 31, 2013 | Registration deadline for substances in quantities of 100 tons and more |
| May 31, 2018 | Registration deadline for substances in quantities of 1 ton and more |
| Note | Voluntary registration prior to deadlines is possible with registration dossiers able to be submitted as of June 1, 2008 |
As for the cost of registration, the Commission has conducted an extended impact assessment on REACH for all industries. The total costs, including those to downstream users, are estimated at 2.8 billion Euros to 5.2 billion Euros ($3.8 billion to $7 billion), depending on the extent to which registration costs will increase prices of chemicals and on the costs of substituting chemicals that will be withdrawn, an estimated 1 percent to 2 percent by the Commission.
While the registration bill may seem hefty, the EU’s reason behind REACH is a strong one. If REACH succeeds in reducing chemical-related diseases by only 10 percent, the health benefits are estimated at 50 billion Euros ($67.9 billion) over 30 years. Macroeconomic effects in terms of GDP are expected to be limited, and REACH is expected to yield business benefits including improvements in innovation, competitiveness and workers’ safety, as well as significant health cost savings. The costs of registration, including the necessary testing, are estimated at 2.3 billion Euros ($3.1 billion) over the 11 years that it will take to register all the substances covered by REACH.
For more on this EU regulation, see our guide to REACH. For more on the REACH restricted chemicals, see this European Commission page.
