[Pharmwaste] New EU rules on chemicals industry enter into force;
environmentalists say not enough
dldebiasi at deq.virginia.gov
Fri Jun 1 16:58:52 EDT 2007
Below are 2 articles on the same news: the Europeon Union (EU) will require a health and safety risk assessment of chemicals that industry wants to introduce effective June 1, 2007.
Chemicals may cause range of health ailments. As new regulations on the chemicals, known as endocrine disrupters, go into effect in the European Union today, select scientists from around the globe met to share their research and growing concerns.
Milwaukee Journal Sentinel, Wisconsin
1 June 2007.
Chemicals may cause range of health ailments
As Europe launches regulations, global scientists huddle on risks
By SUSANNE RUST
srust at journalsentinel.com
Posted: May 31, 2007
Copenhagen, Denmark - Are a group of modern chemicals present in everyday household products behind increasing rates of breast and testicular cancer, male infertility, diabetes and even obesity?
As new regulations on the chemicals, known as endocrine disrupters, go into effect in the European Union today, select scientists from around the globe met to share their research and growing concerns.
Some of the chemicals - found in plastic containers, dental sealants, soda and soup can linings, carpets, paints and pesticides - remain virtually unregulated in the United States.
Europe's new rules require that industries that manufacture or import more than about 2,200 pounds per year of any given chemical will have to provide a risk assessment of that substance. In 2006, the European Union adopted a chemical regulation program called REACH - Registration, Evaluation, Authorization and Restriction of Chemicals.
The program puts the burden of risk management onto industry, and away from regulators.
All chemicals will be registered in a central database, overseen by the EU's Chemical Agency. Over a period of 11 years, more than 30,000 chemical substances will be registered.
"I think the program is fundamentally good," said Andreas Kortenkamp, a researcher at the School of Pharmacy at the University of London.
Although the regulatory requirements have been "pretty watered down" since they were first proposed, the effect of the registration will be to fill in "an enormous data gap," he said.
Indeed, of the 30,000 chemicals required for registration, more than "90 percent of them have no data," he said. The chemicals that have been investigated, he said, were chosen haphazardly - the results of laboratory accidents.
"Now the door is open to apply this more systematically."
"We have been and continue to be concerned about the REACH program for a number of reasons," said Mike Walls, managing director at the Virginia-based American Chemistry Council, the trade association that represents the U.S. chemical industry.
Walls called REACH "a very complex and complicated system," and one that is untested. "At a minimum we think it is inappropriate to look to REACH as a model when there is no experience under it."
Walls said the U.S. already has the Toxic Substances Control Act enforced by the Environmental Protection Agency, and added, "we think that's working very well."
But Frederick vom Saal, an endocrinologist at the University of Missouri, was concerned about the EU program's reliance on corporations and industry.
"They are holding court on this data. They're the ones who will analyze the data and present the data," he said.
Subject of concern
In a study published in 2005, vom Saal showed that 100% of studies conducted by industry on the safety of bisphenol-A, which is an additive in polycarbonate plastics, showed that the chemical was safe.
Not one independent government or academic study has come to the conclusion that the chemical is safe, according to vom Saal.
"We need independent evaluation," vom Saal said.
For several years, scientists have been concerned about bisphenol-A. Hundreds of papers have shown that it can be toxic in extremely low doses. The chemical mimics estrogen and binds to estrogen receptors on cells. In more than 100 experiments conducted on lab animals, it has been shown to cause genetic changes leading to prostate cancer, as well as decreased testosterone, low sperm counts and signs of early female puberty. Work also has been done on human tissue, with results showing that exposure can cause changes in prostate and breast tissue.
Traces of bisphenol-A have been found in nearly every American tested for it.
Industry groups have claimed that the levels at which humans are exposed are too low to cause harm. They have provided about a dozen of their own studies to support this contention.
Walls said the public should have confidence in industry studies because they are performed in accordance with good laboratory practices, must follow a written protocol and must adhere to procedures for accurate and complete data collection.
This week's workshop in Denmark brought together more than 150 top researchers in the field and focused on new research exploring these chemicals.
Niels Skakkebaek, a researcher at Rigshospitalet in Copenhagen, started these workshops after reporting, in the mid-1990s, a precipitous drop in sperm quality and quantity in Danish men. He is concerned that these chemicals are involved in many of the ailments affecting not only Danes, but people throughout the developed world.
Mark Johnson of the Journal Sentinel staff contributed to this report.
New EU rules on chemicals industry enter into force; environmentalists say not enough. Far-reaching rules governing the multibillion-euro chemicals industry entered into force Friday, but environmentalists and consumer groups complained the legislation does not go far enough to protect human health. Associated Press. 1 June 2007.
New EU rules on chemicals industry enter into force; environmentalists say not enough
The Associated Press
Friday, June 1, 2007
BRUSSELS, Belgium: Far-reaching rules governing the multibillion-euro chemicals industry entered into force Friday, but environmentalists and consumer groups complained the legislation does not go far enough to protect human health.
The law bans some of the most dangerous chemicals from use in the 27-nation European Union. Some 30,000 other substances used in products ranging from detergents to toys will have to be registered in an EU database.
The law — known as REACH, for Registration, Evaluation and Authorization of Chemicals — is a compromise balancing health and environmental concerns against fears that excessive red tape would stifle business. It puts the burden of proof on companies to show that industrial chemicals and substances used in everyday products are safe.
"The EU is providing itself with the most progressive chemicals legislation in the world," said EU Environment Commissioner Stavros Dimas.
The database will be managed by a new EU chemicals agency, which opened Friday in Helsinki, Finland. The chemicals industry will pay for all the tests, while the EU will pay for running the agency.
Businesses are critical of the law, arguing the registration of products they make will cost up to €5.2 billion (US$7 billion) and involve excessive bureaucracy.
Environmentalists and consumers, on the other hand, are concerned that not enough chemicals will get tested, and that many high-concern chemicals may be allowed onto the market if producers can prove they can adequately control them.
"Thousands of chemicals will escape any requirement to provide sufficient health and safety information. And many chemicals that can cause cancer, birth defects and reproductive illness will still be allowed in manufacturing and consumer goods," said the World Wildlife Fund, Greenpeace and other environmental organizations in a joint statement.
Some 13,000 substances deemed to pose some sort of health or safety risk will face automatic testing. But almost all tests will be waived for little-used chemicals of which only 1 to 10 metric tons are produced or imported into the EU annually.
REACH replaces some 40 different EU rules currently governing the use of chemicals in the EU. In the past, companies could sell almost any chemical without being required to provide detailed health and safety information.
The chemicals industry employs some 1.3 million people in 27,000 companies in the EU.
Deborah L. DeBiasi
Email: dldebiasi at deq.virginia.gov
WEB site address: www.deq.virginia.gov
Virginia Department of Environmental Quality
Office of Water Permit Programs
Industrial Pretreatment/Toxics Management Program
Mail: P.O. Box 1105, Richmond, VA 23218 (NEW!)
Location: 629 E. Main Street, Richmond, VA 23219
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