The big test

On 17 November, the European Parliament voted in favour of far-reaching legislation that will require safety testing of thousands of chemicals. The law, called REACH - registration, evaluation and authorisation of chemicals - requires the establishment of a single database of all chemicals used in the European Union.

The industry says the process will impose huge costs, put some chemicals out of circulation and cause some companies to flee the EU. Increased testing requirements will also have knock-off effects on R&D in larger companies and could spell the end for many cash-strapped small and medium enterprises.

Under REACH, all chemicals will have to be registered for each use. Those considered to have insufficient data sets will be tested (evaluation). And a small number of potentially hazardous chemicals will require special authorisation.

A process that takes years

Getting a chemical though the process takes years and requires a plethora of experts, including regulatory affairs consultants, chemists, toxicologists and environmental fate specialists. Before any testing is considered, a regulatory affairs officer will evaluate existing data and advise on whether further testing is required. If testing is required, low-volume chemicals will go through basic tests. High-volume chemicals (more than 100 tonnes a year) will require additional long-term animal testing.

"Extra testing will be required no matter what way you look at it," says Peter Newport of the British Chemical Distributors and Traders Association. But he says there may not be enough independent labs to deal with it.

Knight agrees that current staffing and facilities are an issue. A survey conducted in 2001 for the UK government revealed that there are only 16 contract research organisation in the European Union capable of undertaking regulatory testing of industrial chemicals, and thir average annual capacity is only 40 chemicals. And although two-thirds of the 30,000 chemicals originally earmarked for testing may now be exempted, this leaves a significant shortfall.

But Knight believes that services will expand to meet the market. A major downside, however, is the uncertainly over when and how REACH will come into force, which makes deciding when and how to invest complicated.

LGC, the privatised former UK Laboratory of the Government Chemist will not be doing any REACH testing, but has entered into an agreement with the UK Chemical Industries Association to develop a REACH centre. "It is anticipated that this centre will provide a range of support services towards the best response for industry to REACH," says LGC's Peter Lyne.

The centre will offer a range of services including advice on new procedures, consortium facilitation, data management, chemical safety reporting and coordinating independent verifiers, research and test services.

The date keeps slipping

REACH was due to come into force at the end of 2007, but that seems unlikely now (see REACH's tortuous timetable). "There has been a series of target dates that are constantly going back and there is no reason to see that changing," says Newport. "The Austrians take over the EU presidency in 2006 for six months. REACH is not a priority for them, and they are not expected to progress it," he says.

And even when the time does come to invest, there could be a severe lack of scientists to fill specialist roles. "There are a certain number of specialists around, but my guess is that under REACH, there will be shortage of regulatory (eco)toxicologists (in the EU) and chemists (in the UK) with sufficient experience. Although testing will be phased in, chemists will be needed early on and they make the best regulatory consultants," says Newport. "To be frank, they are the best equipped to be a 'jack of all trades', to evaluate test data and write expert reports."

Newport estimates that the number of regulatory affairs consultants, which currently stands at around 100 in the UK, will more than quadruple.

Many large companies have their own chemists to do REACH testing. But these are chemists who would otherwise be developing new products or new uses for existing products.

Newport says he is aware of two global players, one in petrochemicals, the other in organics, that will be taking staff off product support to do REACH testing.

The diversion of staff and funds into testing and "rescuing" existing products and uses will slow things down, says Ingrid Nienaber, a spokesperson for German chemicals giant BASF. And she adds that development of possibilities for new applications with existing substances will not only be slower but more expensive because any new use will require a new registration.

It is this requirement to register for each use that could hit smaller companies and labs. Manufacturers are not currently required to register for a particular use, which means that a small company could lose its supplier of a chemical vital to operations.

If a chemical needs evaluation and/or authorisation for a particular use, a manufacturer may chose not to register it for that use. If they do register, they may seek to pass on extra costs to customers. If they stop supplying it, this will put extra pressure on the remaining manufacturers. "Either way, the cost will go up," says Newport.

By the end of 2006, half of existing biocidal actives will be withdrawn, under the Biocidal Products Directive. "REACH has similar objectives so it is reasonable to assume that a proportion of chemicals will also be dropped," says Knight.

If a company cannot find a new supplier, it may have to reformulate it products or, if that is not possible or too expensive, withdraw them.

Alternatively these companies can register chemicals for a particular use themselves or collectively as part of a consortium. "But they have to be able to resource data themselves and produce chemical assessment reports," says Newport. But paying the associated fees may be too much for small companies.

"There are a lot of ifs and buts and hypothetical scenarios regarding what will and will not required," says Newport. "What prevails in the end depends on whether common sense rules."