EU chemicals safety proposals a real challenge to industry

16 February 2001 16:30  [Source: ICIS news]

The onus for chemicals testing and the provision of acceptable safety data falls on the industry in the new European Union (EU) chemicals white paper proposals. The European Commission (EC) sees adoption of the white paper as one of its most important sustainable development initiatives. Chemical companies disagree and see behind the proposals strong moves to arbitrarily impose product bans. The white paper certainly tests the industry's concept of sustainability to the full.

The Commission talks in one breath about substituting dangerous with less dangerous substances and the precautionary principal. This has to ring alarm bells in a manufacturing sector which believes that risk assessment based on sound science has to be the way forward.

The full white paper is not yet widely available but its existence has already led to a number of chemicals scare stories in the British press. The drafting of this document has also highlighted the differences of opinion in the Commission between the environment and enterprise directorates. The development of that conflict will become more apparent when it is known which party acts as rapporteur as the white paper proposals make their way through the European Parliament.

Environment Commissioner Margot Wallstrom, says that the Commission has decided on a "step-by-step approach to phase out and substitute the most dangerous substances, the ones that cause cancer, accumulate in our bodies and in our environment and affect our ability to reproduce". Enterprise Commissioner Erkki Liikanen says that the EC's new strategy is "crucial to get good and reliable information on the basis of which we can start analysing the many chemicals on the market on which we have no knowledge of their effects on the environment and our health".

The industry has maintained for some time now that a lot of health and exposure data on a lot of substances are available. The point is that these data have not been collected and used in any structured way to assess chemicals safety. If that is indeed the case, then a rapid acceleration of data collection is required and a streamlined process to assess the data and any new research is needed.

The white paper proposals unfortunately suggest none of these, rather a system that looks as if it will be unwieldy and just serve to delay the testing process. The industry federation, Cefic, says that the introduction of increased bureaucracy will mean "more testing of more chemicals using more animals" and slow down progress.

The EC proposals are that the industry will be responsible for supplying data about a particular chemical and the authorities will be called in to evaluate the data and decide on substance-tailored testing programmes. Formulators and downstream users will also have more responsibility and have to supply data on the particular uses they make of that substance.

The new assessment system is known as 'Reach', an acronym that is derived from the three elements of the proposals: registration, evaluation and authorisation. Registration covers basic information submitted by companies on about 30 000 substances produced in quantities of more than one tonne to be held in a central database. The estimate is that about 80% of these substances will only require registration.

Evaluation will be applied to all substances produced in volumes of more than 100 tonne/year and look at long-term exposure. This will apply to about 5000 substances, or some 15% of chemicals currently on the market.

Cefic warns that the new 'authorisation' step is the most worrisome and appears to be based on a chemical's intrinsic rather than actual properties. The EC says that 'authorisation' will apply to substances which 'are carcinogenic, mutagenic or toxic to reproduction (CMRs) and persistent organic pollutants (POPs)'.

Certainly, in the first instance, this takes the CMRs and the POPs debate another step further. Over the longer term it presents a real challenge to industry to accelerate its high production volume (HPV) chemicals testing initiative and the ideas it has for streamlining the whole chemicals testing process.

Registration dossiers for the 1000 tonne/year plus chemicals are expected to be submitted to the relevant authorities by the end of 2005. The deadlines for 100 tonne and one tonne production limit chemicals are 2008 and 2012 respectively. There is a great deal of work to be done.

By: Nigel Davis
+44 20 8652 3214

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