EU environment ministers met on Monday to further debate key issues related to the chemical substances review, which has become one of the fiercest political battlegrounds ever in the history of EU policy definition.
The review has wide implications for industry competitiveness and innovation on the one hand, and health and the environment on the other.
The latest report from this meeting has been forwarded to the full assembly for the EU Parliament plenary vote, scheduled for 15 November 2005.
A Competitiveness Council political agreement is expected on 28-29 November and it is hoped that final approval of REACH regulation can be reached by the end of the first quarter 2006.
On October 29 2003, the European Commission adopted a proposal called REACH (Registration, Evaluation and Authorisation of CHemicals), a new policy designed to replace the current dual system for assessing risks of "existing" (placed on market before 1981) and new chemical substances and will also reverse the burden of proof from the authorities to the companies themselves, for the testing and risk assessment of chemicals.
REACH will register and control approximately 30,000 chemical substances, requiring companies to provide health and safety data on every chemical that it manufactures or imports, with the aim of increasing the safety of humans and the environment. A European Chemicals Agency will monitor the process.
After months of debate between those defending the environmental and health objectives of REACH and those defending industry, an EU Competitiveness Council meeting on 11 October 2005 managed to outline a possible compromise on the registration aspects of REACH.
There now appears to be broad support for requiring less safety data for chemicals produced or imported between 1-10 tonnes a year. Categories of use and exposure to chemicals would be the key factor to determine whether extra information would be required from companies.
The measure is aimed to cater for the concerns of small and medium businesses (SMEs) that fear they could be driven out of business because of the high administrative costs that REACH is expected to entail.
A broad consensus has also emerged in requiring lighter safety data for substances in the 10-100 tonnes category. Only a 'core' data set would need to be submitted to the agency (a compulsory test for reproductive toxicity).
The idea of granting registration exemptions for substances which are not of very high concern to health or the environment is also proving popular. The exemption would be granted along exposure categories but with decreasing tolerance as the exposure increases.
The move is welcomed by industry. However, reducing registration requirements for low-volume chemicals is fiercely criticised by environmentalists who highlight that the exemption system would concern 17,500 out of the 30,000 to be tested under REACH.
There is also consensus among ministers for a proposal to require companies to submit joint registrations for the same substance ('One Substance, One Registration' -OSOR).
This is aimed at reducing administrative costs. However, there are still concerns that SMEs are ill equipped to face the legal implications of negotiating confidentiality clauses with large firms in a consortium.
For the chemicals industry and its downstream users (e.g. carmakers), REACH conjures up fears of bureaucracy, cost, lack of flexibility, loss of competitiveness and job losses and it has been lobbying strongly to water down the REACH proposal.
European enterprises produce 31 per cent of the world's chemicals and the EU's chemical industry is the third largest manufacturing industry, generating 1.7 million jobs and more than 3 million jobs indirectly.
On the other hand, the European Trade Union Confederation (ETUC) is calling for more ambitious chemicals reforms to maintain the health and safety of industry workers.
According to ETUC, one out of every three occupational diseases recognised annually in the EU is from exposure to dangerous chemicals. It hopes that REACH will facilitate the avoidance of many chemicals-related occupational diseases in the future.
The environmental movement are also greatly in favour of REACH's potential benefits in assessing and controlling environmental impact of hazardous chemicals.
On the economic impact of the proposed legislation, the Commission, industry and non-government organizations (NGOs) have all come up with very different estimates.
The Commission estimated the overall economic impact at around €2.3 billion over 11 years (0.05 per cent of the annual turnover of the sector), but these figures were heavily disputed by industry studies performed by the German BDI and the Mercer study in France. Industry therefore insisted on an independent extensive impact assessment of REACH.
The NGOs compared the costs to industry with the financial gains from reductions in public health costs and less negative impacts on the environment. A study for World Wildlife Fund (WWF) estimated the financial gains at around €283 billion over 30 years.
A recent study commissioned by the ETUC showed REACH could help avoid 50,000 cases of occupational respiratory diseases and 40,000 cases of occupational skin diseases caused by exposure to dangerous chemicals in the EU every year. This would amount to €3.5 billion of savings over a ten year period, assuming that the final version is identical to the one originally tabled by the Commission in October 2003.