Will REACH be reached


The European Union (EU) is progressing along the lengthy route towards establishing legislature to register and evaluate the myriad chemicals used in everyday products. But with each delay, say critics, more flaws appear.

BioMedNet, News, 1. Dezember 2003


BMN011203 - The size of the project is unprecedented, and probably no one in the EU knows everything about the legislative system being developed. Over 100,000 substances that have never been tested for their toxicity are used in various consumer goods from cleaning products and cosmetics to children's toys. This is planned to change, at least for some thousand substances, with the new EU legislation: Registration, Evaluation and Authorisation of Chemicals (REACH).

The aim of REACH is to shift the responsibility from national institutes to private companies and producers, which have to register every substance that is recorded in the new chemicals list. The requirements concerning the scale of information are graduated depending on production volume.

After the EU issued a White paper on REACH in 2001, criticism was raised across the board, from environmentalists and industrialists, politicians and scientists. Following the outcry, it seemed that the longer the project took, the weaker the system became. But now, agree experts, some of those criticisms have been addressed.

Currently, there are three categories in which chemicals are classified according to their potential as carcinogens, mutagens or toxins that affect human reproduction. Category 1 substances are known to be harmful in one of these ways for humans (e.g. benzol). Category 2 substances have a high probability of toxicity in one of these ways (e.g. o-Toluidine). All category 3 substances show only indications for harmful effects, but not enough information is available (e.g. Anilin or Acetaldehyde).

This summer, the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) - responsible for the assessment of potential risks of substances in Germany - criticized the EU for including in their latest draft only chemicals for which carcinogenic, mutagenic or 'reprotoxic' effects had been definitely proven in humans.

For precautionary consumer protection purposes, claimed the BfR, this was not enough. "The authorization must be extended to encompass chemical substances for which up to now only indications of such effects are available," said Ursula Gundert-Remy of the BfR.

After the latest revision, issued at the end of October, the proposals have been partly considered. Not only do category 1 chemicals have to be authorized, but also category 2 chemicals that are not definitely established as such. Substances for which there is only weak evidence that they are harmful do not have to be authorized. But those chemicals do now have to be assessed, which means registered. "Itęs better than nothing," said Gundert-Remy.

But whether this is really better, only time will show. The main idea behind REACH is, as Gundert Remy says, to speed up the proof of thousands of common, "old" chemicals that have never been evaluated. Generally, the BfR is of the opinion that REACH will mean progress for consumer health protection, because: "Since 1994 we were able to check only 70 of these old substances." Evaluation takes a long time. Evaluating vinyl acetate, for example, took from 1997 to 2003. "Mainly because companies need so much time to send us information," said Gundert Remy.

Bearing in mind that one single study on carcinogenicity takes two to five years, the goal of assessing several thousand substances in the course of ten years seems to be more than ambitious. By way of comparison: the most extensive toxicological test program in the world, the National Toxicology Program of the United States took 20 years to test the carcinogenic effects of only 500 chemicals. In the opinion of the BfG any failure by industry to submit their data by the stipulated deadline should have clear consequences.

"This is the only way of ensuring that manufacturers will do everything they can to comply with the deadline," said Gundert-Remy. What those consequences will entail remains to be seen. The consumer is entitled to know which substances surround them and are contained in the products they use every day. "This right," concluded Gundert-Remy, "must be enforced today and not reserved for future generations."

BioMedNet, News, 1. Dezember 2003

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