There are good reasons why European leaders supported moves to tighten the regulation of chemicals by approving the REACH (registration, evaluation, authorization and restriction of chemicals) legislation, which became law in 2006.
The lack of information on how even commonly used substances might harm people and the environment is an internationally recognized problem. REACH is Europe's bold attempt to comprehensively fill this knowledge gap and regulate substances accordingly.
Under the first phase of the legislation, companies from around Europe had to file comprehensive safety data on more than 3,000 substances by December last year. But as we reveal in our News story on page 150, the first independent analysis of the filed data shows that REACH is unlikely to work as planned.
Central to the problems identified by Costanza Rovida, a consultant chemist based in Varese, Italy, is that chemical companies have failed to fill gaps in safety data as required.. What's more, European regulators seem to have little leverage to force them to do better.
“Is burdensome and ineffective regulation better than no regulation at all?”
REACH is often touted as Europe's most complex piece of legislation, but at the moment it looks toothless. Rovida's analysis raises an urgent question: is burdensome and ineffective regulation better than no regulation at all?
There are some parallels with, and perhaps lessons to be drawn from, the difficult birth of Europe's carbon-emissions trading scheme, which, like REACH, has lofty goals — in this case to reduce Europe's carbon footprint. Flaws in the design of the scheme resulted in farce, ridicule and zero reduction in carbon emissions in its first phase, from 2005 to 2007. But subsequent reform made for a stronger second phase, which is now drawing to a close. Details of the third phase are currently being hammered out.
Like REACH, the success of the emissions-trading scheme largely depends on self-reporting by companies — in this case of their annual carbon emissions, for which they get carbon allowances of a corresponding size. Honest participation is encouraged by independent third parties and national authorities that check each submission for accuracy. Hefty fines lurk for those who stray too far from the truth.
It is still early days for REACH, but there are few signs that Europe has the appetite to improve on its dismal first phase in the way it did with emissions trading, or that it will do more than encourage chemical companies to play by the new rules.
Jukka Malm, director of regulatory affairs at the European Chemicals Agency (ECHA), the body responsible for REACH, says he hopes that industry will up its game, but he can do little more than finger wagging to spur it on.
The companies know, as does the ECHA itself, that the agency's biggest weakness is that it has resources to check only a fraction of all data submissions for accuracy and compliance. To deny the regulator the muscle it needs to properly police submissions is a major flaw of the present design of REACH. In addition, there is no immediate threat of legal and financial sanctions against companies that fail to comply.
Nevertheless, REACH has not been a complete flop. It has motivated companies to dig around in their archives and make public old safety data that they had lying around on the substances they produce. It has also got companies to work together and share data.
But these gains are modest in comparison with the new laws' failures. Notably, they have resulted in only small improvements in filling gaping holes in the available data about potentially serious effects of substances on reproduction and development.
And it is also disappointing that the regulations have failed to encourage companies to explore alternatives to animal testing in response to the demand for more data.
What now? If European leaders allow business as usual, they will find themselves under pressure to scrap REACH completely. It will quickly reach a point where its costs, in terms of time and money, heavily outweigh the meagre gain in information.
That would be a missed opportunity. The legislation rightly aims to correct some serious problems, even though Rovida's analysis has identified real difficulties. Europe has until the 2013 deadline for the next phase of submissions to admit that it has a problem, and to reach a little further to solve it.