The new regulatory framework for chemicals looks set to improve conditions for innovation in Europe, according to EU Commissioner for Enterprise and the Information Society, Erkki Liikanen.
The proposed legislation - named REACH (Registration, Evaluation and Authorisation on Chemicals) - will require chemical manufacturers and importers to provide European regulators with basic scientific data for all chemicals produced in quantities more than one tonne. More extensive safety data will be required for chemicals produced in higher volumes, as well as those that are of special concern.
Under the 40 different pieces of current legislation, chemicals introduced after 1981 have to be notified and tested in production volumes as low as ten kilograms per year, according to Liikanen. He said that many experts believe that this has inhibited R&D, stifled innovation and encouraged the continued use of untested chemicals from before 1981 because it is easier and less expensive.
Speaking at a press conference on the REACH system, Mr Liikanen said that increasing the threshold for registering new substances from 10 kilograms to one tonne will not only generate more research and development on substances, it will also help make the EU chemical industry more competitive, and in turn, innovative.
"The reality is that without competitiveness there are no new jobs and we cannot invest in a better environment and better health services," he said. "Only competitive businesses can generate the resources for R&D and innovation. And innovation is needed for new and safer chemicals and processes."
Another incentive for research included in the new system, he claimed,is the lengthened trial period allocated for R&D activities. Instead of having only six years to test a chemical, companies will be exempt from registering a chemical for up to 10 years, and this period may be extended for a further five years for medicinal products.
One senior chemical industry executive who is not convinced by the merits of REACH is Bruce Olson, executive vice president of sales and marketing at Bayer Chemicals. He gave the CPhI conference his own take on the European Union's legislation, albeit just ahead of the presentation of the latest proposal on 29 October.
"Before creatinbg additional burdens, especially for small and medium-sized enterprises and implementing additional bureaucracy for the European chemical industry in general, it needs to be recognised that comprehensive regulations and safeguards already exist covering new substances," he noted.
Giving the voluntary commitment of the German chemical industry, under the auspices of the industry association (VCI), he suggested that REACH will not provide a noticeable improvement in consumer and environmental protection, and could have a significant, negative impact on the global competitiveness of the European industry.
Nevertheless, Liikanen said that exempting certain polymers from registration, reducing information requirements and removing the need to complete chemical safety assessments below ten tonnes are just some of the changes that streamline the system.
"These changes have significantly reduced the burden on downstream users and are critical to encouraging manufacturers to maintain products on the market. This is vital for innovation in downstream industries," he added.
The proposed legislation will now be forwarded to the European Parliament and the Council of Ministers for adoption.