European Parliament Adopts World's Strictest Chemicals Law

STRASBOURG, France, December 14, 2006 (ENS) - The European Parliament Wednesday approved a new regulation for 30,000 chemicals which will oblige producers to register all chemical substances produced or imported above a total quantity of one metric ton per year. Many are chemicals used in everyday products such as cosmetics, toys and building materials.

The most hazardous substances, such as those that are very persistent and those that accumulate up the food chain, will not be authorized if safer alternatives exist.


Under the new regulation high volume chemicals must be registered, evaluated and authorized. (Photo courtesy IGB)
Producers will have to submit a substitution plan to replace these toxic chemicals with safer ones. When no alternative exists, producers must present a research plan aimed at finding one.

The substitution measure covers about 3,000 of the most hazardous chemical substances.

The regulation, known as REACH for Registration, Evaluation, Authorization and Restriction of Chemicals, replaces 40 legislative texts that now govern chemicals in the European Union.

European Parliament President Josep Borrell said, "This vote, on one of the most complex texts in the history of the EU, sets up an essential piece of legislation to protect public health and the environment from the risks of chemical substances, without threatening European competitiveness. It offers EU citizens true protection against the multitude of toxic substances in everyday life in Europe."


Josep Borrell of Spain heads the European Parliament. (Photo courtesy European Parliament)
The regulation will enter into force in June 2007, and the registration process will take 11 years to be completed. The calendar for registration depends on the risk of the substance and the quantity produced, but all covered substances will have to be registered by 2018.

REACH also creates a new Chemicals Agency, to be based in Helsinki, Finland which will be responsible for the authorization process.

An EU environment ministers' council on December 18 is expected to approve the regulation on what will become REACH's official birthday almost seven years after the European Commission began work on the legislation.

European Environment Commissioner Stavros Dimas said, "REACH is an extremely important piece of legislation, which will significantly improve the protection of human health and the environment. It will increase our knowledge about chemicals, enhance safety, and spur innovation while encouraging substitution of highly dangerous substances by safer ones."

But environmental and consumer groups say the REACH regulation does not go far enough.

"Major loopholes in REACH will still allow many chemicals that can cause serious health problems, including cancer, birth defects and reproductive illnesses, to continue being used in manufacturing and consumer goods," according to a joint statement by Friends of the Earth Europe, Women in Europe for a Common Future, Greenpeace Europe, Eurocoop, the Health & Environment Alliance, and the European Environmental Bureau, which represents 143 member organizations in 31 countries.


Acetyls chemical complex at BP's Saltend Works, Hull, England (Photo courtesy FreeFoto)
The European chemical industry has lobbied long and hard to shape the regulation in their favor during the three years of negotiations that led to its adoption by Parliament Wednesday. The environmental groups note that industry won concessions that weaken the rule.

"Further concessions exempt companies which import and manufacture chemicals in volumes below 10 tons a year - 60 percent of chemicals covered by REACH - from the requirement to provide any meaningful safety data," the groups said.

Now that the REACH regulation has been adopted, the chemicals industry is committed to making it work said Alain Perroy, director general of the European Chemical Industry Council, Cefic.

"The European chemical industry will see REACH as an opportunity to demonstrate that companies have a solid knowledge of chemicals and strong product management practices to ensure chemical safety," said Perroy. "The industry wants to make REACH work; Cefic will play an active role in helping companies to comply with the regulation."


Polyvinyl chloride, PVC, is the most widely used polymer in building and construction applications and over half of Western Europe’s annual PVC production is used in this sector, including PVC plasticized with phthalates. (Photo courtesy Phthalates Information Center Europe)
Japan's chemical industry said today it is concerned about the effects of REACH.

"There are many unclear parts concerning the actual implementation of the law, such as the registration procedures, including data sharing, and it is anticipated that there will be confusion when the law comes into force," the Japan Chemical Industry Association said in a statement.

U.S. environmental organizations say they will use REACH to lobby for stricter controls on hazardous chemicals in the United States

"REACH is the world’s most ambitious attempt to eliminate the dangers of untested, unregulated chemicals that are found at work, in our homes and in our bodies, said Daryl Ditz, senior policy advisor at the Center for International Environmental Law, based in Washington, DC.

"To protect the health of Americans and the competitiveness of US companies, we must now overhaul our own laws on toxic chemicals," he said.

Ditz said the United States is already falling behind in the global shift toward safer, non-toxic products. "As one example, toxic toys containing phthalates, which are linked to permanent birth defects in the male reproductive system, were banned years ago in the EU, but are still on U.S. shelves," he said. The city of San Francisco recently banned toys containing phthalates and is now being sued by the chemical industry.

The REACH regulation transfers the burden of proof regarding testing and evaluation of the risks of chemicals from the authorities to industry.

As MEPs wanted, the "duty of care" principle will be enshrined in the regulation. It will stipulate that the manufacturing, import or placing on the market of substances must be done prudently and responsibly, to ensure that, under reasonably foreseeable circumstances, human health or the environment are not adversely affected.

This will involve collecting all necessary information on the substances in question and relaying all recommendations about risk management along the distribution chain.

The promotion of alternatives to the animal testing of chemicals, an issue of prime concern to Members of the European Parliament, MEPs, is now included among the goals of REACH. Information on toxicity to human beings should, if possible, be determined using means other than tests on vertebrate animals, the regulation states.


Monkey used in testing (Photo courtesy PETA)
Groups that had campaigned to abolish animal testing applauded the measure, which they said will save the lives of millions of animals.

"While we absolutely condemn the short-term need for more animal tests in Europe as a result of forthcoming European legislation on chemicals, REACH, we are glad the European institutions appear to have listened and worked hard to vastly reduce the scale of suffering in the longer term," said the British Union for the Abolition of Vivisection.

Still, European environmental groups are wary of the effectiveness of the new regulation.

They worry that "loopholes and provisions for self-regulation" leave REACH "vulnerable to further manipulation by the chemical industry."

There is no guarantee that information from third parties about safer alternatives to hazardous chemicals will be considered in every case, they point out.

"The new EU Chemicals Agency in Helsinki will have to be closely monitored to ensure that REACH can deliver," the environmentalists warn. "Without the necessary support, hazardous chemicals will continue to contaminate wildlife, our homes and our bodies, and REACH will prove a failure."