11 October 2006

Europe takes lead in safe chemical production

Briefly:
New safety rules applying to Europe's chemical industry will squeeze low value-added chemical production

The European Commission will shortly take the final vote on REACH, a brave new world in safety regulations for chemicals in Europe. The REACH initiative, which stands for Registration, Evaluation and Authorisation of Chemicals, aims to improve Europe's industrial competitiveness and prompt innovation towards the use of safer chemicals.

Industry has reacted strongly to the plan, which will require that as many as 100 thousand chemicals undergo a round of health and safety testing at the expense of manufacturers. Europe's chemical industry employs 1.7 million people and creates a trade surplus of €41 billion annually.

The Commission received 6000 responses from industry, NGO's and governments during a short consultation period in 2003. And a trial of the program in 2004, involving 29 chemical producers, spawned a report with more than 40 recommendations on how the program could me made "workable".

Of the two stated aims of REACH, the safety argument is mentioned most frequently in reports and press releases made by the Commission. One press release claims that safety information is "sketchy for around 99%" of chemicals in the market place, "raising questions about the possible impact on human health".

Supposing this is true, the question on my lips is how REACH will prompt innovation towards safer chemicals? The toxicologists I speak to are fairly divided about which direction this innovation could take. Some talk about the new field of toxicogenomics, which combines conventional toxicology insights with genome-wide experimental investigations.

Others talk of computational approaches involving machine learning algorithms, Bayesian prediction and other exotic methodologies. REACH makes no mention of these new methods. Indeed, the only statement I could find about how REACH would work in practice was a lonely objective that it should not increase the amount of animal testing.

Wading through the flurry of recent reports and press releases on REACH, I found a small section that compared the new proposals with the existing chemical safety rules. REACH will exempt chemicals used in quantities of less than 1 tonne from the new screening requirements. Currently, all new substances produced in quantities of more than 10 kilograms require safety screening.

With this change in policy, only 30 thousand of the 100 thousand chemicals classed as "sketchy" by the Commission will qualify for screening. So safety compliance will actually become easier under REACH, assuming today's annual production rates.

My guess is that this new rule will have an impact on the second stated aim of REACH, namely, improving Europe's industrial competitiveness. Many of the nano-particle producers should be able to satisfy demand by producing less than the 1 tonne annual threshold. An exotic component in a high-end memory device might weigh less than a microgram per unit.

The same rule will make large scale production of low added-value products unprofitable under REACH. That is because each product made currently could contain 10's or even 100's of individual chemicals that require testing under REACH. With testing costs eating into low profit margins, production is likely to move away from Europe.

So in summary, REACH looks to me like a friendly move for manufacturers of low-volume, high value-added chemicals. For my money, this could have a positive impact on Europe's tradition as a place of high value-added chemical manufacturing.