Registration, Evaluation, Authorisation and Restriction of Chemicals

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation, regulation 2006/1907 of 18 December 2006. REACH covers the production and use of chemical substances, its 277 pages took seven years to pass. It has been described as the most complex legislation in the Union's history^[1] and the most important in 20 years.^[2] It is the strictest law to date regulating chemical substances and will impact industries throughout the world.^[3] Since it came into force in June 2007 REACH requires all chemicals of one tonne or more in volume that are manufactured in or imported into the European Union each year to be tested for health and safety and registered with a new central European authority – the European Chemicals Agency located in Helsinki, Finland. REACH encourages manufacturers and importers (M/I) of such chemicals to pre-register them during the 6 month pre-registration period - June 1, 2008 to December 1, 2008. This will allow the companies much more time before they have to test and fully register the chemicals.

REACH also applies to all chemicals that are considered of very high concern to human health or the environment - regardless of volume. Depending on the substance in question and its use, producers and importers may be obliged to investigate its effects on human health and the environment. The most hazardous chemicals - carcinogens, reproductive toxins, or those that accumulate in humans or animals - can only be used if authorized by the European Chemicals Agency.^[3] REACH applies to all chemicals imported or produced in the EU, in contrast to the US Toxic Substances Control Act which only applies to chemicals newly coming into use. The European Chemicals Agency will manage the technical, scientific and administrative aspects of the REACH system.

The European Commission supports REACH affected businesses by handing out - free of charge - a software application (IUCLID), which simplifies capturing, managing and submitting of data on chemical properties and effects.

REACH will be phased in over 11 years.

Additional recommended knowledge

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History

REACH has already been significantly amended since the original version initiated by the European Commission in 2003. It passed the first reading in the European Parliament on 2005-11-17, and the Council of Ministers reached a political agreement for a common position on 2005-12-13. The European Parliament approved REACH on 2006-12-13 and the Council of Ministers formally adopted it on 2006-12-18. Weighing up expenditure versus profit has always been a significant issue, with the estimated cost of compliance being around 5 billion euros over 11 years, and the assumed health benefits of saved billions of euros in healthcare costs.^[4] However, there have been different studies on the estimated cost which vary considerably in the outcome.

Over time, the amendments have generally been to make the legislation more strict. In October 2006, a new version which would force safer alternatives (rather than recommend) was shown strong support by the European Parliament's environment committee.^[5] In December 2006, the European Parliament approved REACH, which includes legislation that requires companies to submit plans to replace the most hazardous chemicals - either with an existing safer alternative or, if no safer alternative exists, it requires companies to work to find one.^[3]

The European Union's Globally Harmonised System of the Classification and Labelling of Chemicals will complement the new REACH Regulation. The European Commission plans to time the GHS's entry into force as closely as possible to REACH to allow consistency between the GHS and REACH.

Reason behind REACH

The legislation was proposed under dual reasoning: protection of human health and protection of the environment.

Using potentially toxic substances (such as phthalates or brominated flame retardants) is undesirable and REACH will force the use of these chemicals to be phased out or replaced with a safer alternative. Using potentially toxic substances in products other than those ingested by human (such as electronic devices) may seem to be adequately safe at first, but there are several pathways in which the chemicals can enter the human body. The chemicals can leave the device during consumer use into the air, to be inhaled or ingested by human and secondly, the substances could end up in the environment. Here they might not do harm to humans directly, but through the contamination of ground water, these chemicals can enter the food chain through plants, fish or any other animal, and when eaten cause harm. According to the European Commission, little safety information exists for 99 percent of the tens of thousands of chemicals placed on the market before 1981.^[3]

Most toxic chemicals in use today are justified because "at very low levels they are not a concern to health".^[6] However, many of these may bioaccumulate in the human body, or chemically react with one another,^[7] thus reaching dangerous concentrations.

Controversy

REACH has also attracted concern because of the potential for a very significant increase in animal testing under the proposal.^[8]

Animal tests on vertebrates are allowed only once per one substance, and if a company pays for these tests, then it must sell the rights to the results for a "reasonable" price. The price is not defined. Doing the tests again is not allowed, therefore the original registrar gets a monopoly on that substance if they set the price too high.

On June 8, 2006 the proposal came under criticism from a group of nations including the United States, India and Brazil claiming that the bill would hamper global trade.^[9]

Other controversies exist, such as the fact that the mechanism to pre-register and register is not in place. The computers, both hardware and software, are not in place. Staffing is a considerable problem as the needed professionals are unwilling to relocate to Helsinki. No one knows how to register a chemical because there are many unanswered questions regarding how to register chemicals. For instance, polymers are exempt from registration, however, the monomers used to make the polymer are required to be registered. This is a considerable problem as a company who uses a polymer to make a product, may purchase that polymer from another manufacturer who may not be willing to divulge which monomers are used to make the polymer. So how can the monomers be registered?

See also

• European Chemicals Bureau
• Environmental health
• Quality of life
• Consumer protection
• Poison
• Lead poisoning
• Mineral wool
• Carcinogen
• Porter hypothesis
• Directive 67/548/EEC
• EUR-Lex

References

• Schapiro, Mark, "New Power for 'Old Europe'". The Nation, December 27, 2004, 11-16.

Criticism

• BUAV campaign on animal testing under REACH
• Implications for the electronics industry
• Small companies objections to REACH's implementation
• Europe’s Global REACH: Costly for the World; Suicidal for Europe (Hayek Institute, 2005)
• Cartoon examining animal testing under REACH