Are Your Cosmetics Killing You?
06/12/2005

By Philip Bethke

Deodorant, toys and textiles contain tens of thousands of chemicals, but we know almost nothing about how dangerous they are. Can the European Union's new chemicals regulation help improve the situation?

A REACH protest in Munich: Lobbyists have engaged in a bitter battle over the 1,200 EU administrative monster that would regulate chemicals in consumer products.

The testers allowed new cars to sit in the hot sun for three hours. Then, using their testing equipment, they recorded significant levels of dozens of volatile organic compounds, or VOCs, in the vehicles' interiors -- including formaldehyde and benzene.

The irritants were emitted, in a process called outgassing, by enamels and paints, plastics and seat upholstery. The outgassed VOCs even formed a toxic film on the insides of the cars' windshields, in what experts call "fogging."

The environmental organization Global 2000 recently had the interior air in six brand-new sedans analyzed. They found a total of 98 chemicals, "including extremely undesirable substances." Automobile manufacturers countered that the test conditions did not reflect real conditions. But the truth is that even experts can agree on only the fewest of the substances detected.

The European chemical industry uses about 100,000 substances to produce such beneficial consumer products as rubber ducks, insulation material, emulsion paints and night creams. But the astonishing thing is that most of these everyday chemicals, though in use for decades, have never been or have only been insufficiently tested for their potential toxicity.

The problem was first recognized in the European Union in 1981, when a list of these so-called existing chemicals was compiled. That was almost 25 years ago, and this week the European Parliament plans to begin discussions on a new proposal to regulate European chemical laws. The project, known by the acronym REACH ("Registration, Evaluation and Authorization of Chemicals"), would require industry to present data on the safety of all chemicals produced at annual levels of at least one ton.

The bureaucrats in Brussels have managed to put together a 1,200-page administrative behemoth. Former EU Commissioner for Enterprise and Information Society Erkki Liikanen and former EU Commissioner for Environment Margot Wallström submitted an initial version of the document two years ago. Since then, the document has emerged at the center of a bitter dispute among lobbyists. While the chemical industry predicts the loss of thousands of jobs and the collapse of small and medium-sized businesses, environmental groups cite such hazardous chemical-related problems as reduction in sperm counts, cancer risk and contamination of breast milk.

In Berlin and Brussels, the Bund für Umwelt und Naturschutz Deutschland, the German branch of the environmental organization Friends of the Earth, staged a demonstration with actors dressed up as "toxic dwarfs" wearing stocking caps. Chancellor-elect Angela Merkel, a member of the conservative Christian Democratic Union (CDU), favors a pro-industry approach, and last week she got her way in a summit meeting between the two members of Germany's future coalition government, the CDU and the Social Democratic Party (SPD). The two parties' coalition agreement now states that the current REACH proposal "must be modified, with the goal of improving chemical safety, but without increasing the cost of production or obstructing the use of chemicals."

In fact, REACH is hardly practicable in its current form. Nevertheless, the underlying concept behind the mammoth project is viewed as a milestone in chemical legislation. Until now, the EU member states were responsible for testing producers' products for their environmental impact. In the future, however, it will be the producers who will be required to submit data demonstrating the safety of the chemicals they use. This reversal of the burden of proof is seen as a groundbreaking approach to singling out hazardous chemicals. The EU Commission expects the plan to produce healthcare savings of more than €50 billion over the next 30 years. But this comes at a high price to the economy, with industry ultimately expected to lose more than €5 billion.

Thirty thousand chemicals would be subject to the monitoring system, and in the future would have to be reported to a new European chemical agency in Helsinki, Finland. REACH requires that the monitored chemicals undergo various tests, depending on their respective annual production levels. Under the regulations, as the quantity of production of a substance increased, the testing requirements for it would also get stricter. This principle seems obvious, but it too has created an uproar in the industry, which views classification by production volume as nonsense and wants drastic reductions in the testing standards for two-thirds of the chemicals in question. This, in turn, has prompted a vehement response from environment organizations, which have called the industry's proposal a "watering down" of the new system.

Europe's criminal negligence

In truth, Europe has been criminally negligent in addressing the problem of existing chemicals. Meanwhile, consumers are rubbing chemicals into their armpits and washing their underwear with substances whose long-term effects are often unknown.

For example, many cosmetics contain the preservative imidurea, which is suspected of causing genetic damage. Under current law, dyes used in clothing are not required to be tested for adverse effects on the skin, even though some are said to cause allergies. To this day, there is a complete lack of data on the possible damaging effects on reproduction and the environment of fragrances such as Lyral® and amberonne, which are used by the ton in cleaning agents and perfumes.

The list of substances for which there is a glaring absence of data could continue indefinitely. But what is the most sensible approach to assessing the potential dangers of these chemicals?

From a purely toxicological point of view, the answer to this question is clear. It's relatively easy to determine whether a particular chemical is a skin irritant, for example, or is acutely toxic. But whether substances are carcinogenic, have adverse effects on fertility or are even harmful to unborn children can only be demonstrated in long-term studies involving animal testing.

What researchers look for when conducting such tests is what is known as the No-Observed-Adverse-Effect-Level, or the concentration at which a substance causes no damage, even when administered repeatedly. To determine this value, laboratory rats are tormented for at least 28 days with various concentrations of the substance in question, then killed and dissected. The highest concentration at which no adverse effects on the organs and tissue are observed is the limit value. For safety reasons, and because a man and a mouse aren't exactly the same thing, this level is then multiplied by 100 to arrive at the value applicable to humans.

"Without these 28-day studies, it's impossible to determine whether a substance is truly dangerous," says toxicologist Helmut Greim of the Technical University of Munich. In a position paper on REACH, Greim and fellow toxicologists from throughout Europe warn against further cutting back the animal tests currently required for chemicals produced in quantities of at least 10 tons a year. But would large-scale testing with laboratory animals even be reasonable then?

An unusual coalition between industry and animal rights groups opposes more comprehensive testing, but for different reasons. While the friends of the laboratory rat are outraged over the looming mass killing of laboratory animals, protracted animal tests are simply too costly for the chemical industry.

"A number of specialty chemicals could disappear from the market because registration wouldn't be worthwhile," says Manfred Ritz of the German Chemical Industry Association. Ritz proposes that testing requirements not be based on production volume, but on the extent to which workers and consumers come into contact with a given substance. This approach, says Ritz, could produce cost savings of 30 to 40 percent.

"It gives me an upset stomach to think that someone is spending €100,000 to test substances with which only a few people come into contact," says Inge Mangelsdorf of the Fraunhofer Institute for Toxicology and Experimental Medicine in Hanover. However, she agrees with toxicologist Helmut Greim's view that tests like the 28-day study are necessary to truly assess the long-term risks of chemical substances.

But Mangelsdorf also believes that the scope of animal testing should remain within reason. Naturally, substances that are handled directly by consumers must be thoroughly tested. However, she adds, different standards could apply to a process material used in a chemical factory and handled only by specially trained workers.

Mangelsdorf also warns against blanket condemnation of all industrial chemicals. "Environmental groups often create the impression that all chemicals are as bad as dioxin; fortunately this isn't the case."

"We must reduce the risks, but we must also live with residual risk," says Mangelsdorf. After all, she adds, we do the same thing in other facets of our lives. For example, we consume carcinogenic chemicals on a daily basis, often as natural components in our food. At the same time, people become "hysterical" when they discover, for example, that paint contains "minimal amounts" of a carcinogenic substance. Besides, says Mangelsdorf, everyone accepts a certain level of risk in everyday life, simply by driving a car, for example.

What does all this mean for REACH? In the EU Parliament, a majority appears to be forming in favor of a pro-industry compromise. By last week, it was still uncertain as to when the EU Council of Ministers will take a position on the matter. At Merkel's insistence, the meeting scheduled for the end of this month has been rescheduled as a concession to Germany's current process of forming a new government. The final version of the law is unlikely to be finished before 2007.

75 percent of cancer caused by environmental factors

The EU committees must carefully weigh the costs they would impose upon chemical businesses against the amount of residual risk they can expect consumers to continue to tolerate. Meanwhile, environmentalists and members of the medical profession are worried about the long-term effects of chemicals and their accumulation in humans and in the environment. According to a statement issued by the Standing Committee of European Doctors, it is "imperative" that all "suspicious chemicals" be replaced by safe substances. The doctors see the relationship between industrial chemicals and cancer, infertility and allergies as "scientifically proven." "We are in a serious situation," warns French oncologist Dominique Belpomme. He believes that about 75 percent of cancer cases can be attributed to mutations triggered by environmental factors, "especially chemicals."

Last year, 40 members of the EU Parliament were able to experience first-hand just how urgent the problem of existing chemicals is. In a study commissioned by the World Wide Fund for Nature, researchers found a cocktail of 76 different synthetic substances when they analyzed the politicians' blood samples. Their arteries, it turned out, were conduits for the residues of brominated flame retardants, softening agents, fluorine chemicals and polychlorinated biphenyls (PCBs).

The presence of PCBs, considered carcinogenic, highlights why REACH should not be postponed indefinitely. Initial signs of the toxicity of these chemicals surfaced as long ago as 1968, when about 2,000 people who had consumed rice oil contaminated with PCBs in a Japanese food processing factory experienced skin changes and suffered severe organ damage.

Then the world gave these chemicals three more decades to become ubiquitous in the environment, until they had ultimately contaminated breast milk and were even found in seal blubber at the North Pole. But it took until last year for PCBs to become banned worldwide.

Translated from the German by Christopher Sultan http://service.spiegel.de

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