The EU’s REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. The acronym is self-explanatory but another 10,000 pages of guidelines thoroughly explain what the new piece of legislation really means. In a nutshell it is a new chemical legislation with the main objective to ensure that the chemical business uses chemicals in a way that is safe to humans and the environment. The legislation concerns all industries, approximately 29,000 companies, producing or importing chemicals in the EU. About 30,000 of the estimated 100,000 chemicals in Europe are covered by REACH.
Enzymes are regarded as chemicals by authorities although most people might not
consider them as such. “All substances in the EU have to be registered under REACH unless there are specific exceptions. Technical enzymes,
ranging from the detergent, textile, leather, forest product, and cosmetic industries to the
fuel ethanol industry, fall under the new law,” says Rie Tsuchiya, Regulatory Affairs Manager at Novozymes.
The main feature of REACH, compared to the former bundle of some 40 regulations, is
that it shifts the responsibility for providing safety documentation on to the producer. “The EU’s principle ‘no data – no market’ puts a great responsibility on the producer. At Novozymes we already carry out extensive data collection on how enzymes affect humans and the environment. We’re now complementing these data to fit the new requirements,” says Rie Tsuchiya.
Tough times for harsh chemicals, good times for enzymes
REACH encourages the industry to seek alternatives to harsh chemicals. To use “substances of very high concern” under REACH, companies have to apply for a special permit and pay an authorization fee of EUR 50,000. “Enzymes substitute harsh chemicals in many processes, and the legislation focuses on finding more environmentally friendly alternatives. We believe enzymes will receive an even more prominent role as chemical substitutes,” says Rie Tsuchiya.
REACHing the goal
At Novozymes a cross-organizational project group has worked since May 2007 to establish good networks and relationships with collaborating organizations, developing industry standards for safety documentation, and internally ensuring that all involved stakeholders are well informed. “We’ve worked closely with our suppliers and customers to inform them about the implications of REACH. We’re also the driving force, working in consortium with our competitors, to produce various industry guidelines and policy documents,” says Rie Tsuchiya.
The project group assesses and manages all relevant aspects of REACH, including the
technical guidance documents associated with REACH. It draws on expertise from people from many of Novozymes’ business areas, including Regulatory Affairs, Legal, Sales, Product Safety, and Toxicology.
“We believe REACH has great potential in the long run as focus shifts to safe and sustainable chemicals. The foundations of REACH are certainly in line with Novozymes’ biotechnology base and business strategy. REACH will therefore indirectly support Novozymes’ efforts to maintain and grow our existing business, and develop new enzymes and other biobased products,” says Karin Weinell, Senior Manager for
the REACH project at Novozymes.
Facts on REACH
| REACH |
- Registration, Evaluation, Authorisation and Restriction of Chemicals
|
| Scope |
- 10,000 pages of text
- 30,000 chemicals to be registered over 11 years
|
| Cost |
- The European Commission estimates REACH will
cost the industry EUR 2.8–5.2 billion
- The Commission estimates to save EUR 54 billion
in healthcare costs as the exposure to dangerous
chemicals is reduced |
| Process |
- REACH entered into force on June 1, 2007. It
requires basic safety data on every chemical in
the EU and will restrict any substance deemed to
endanger health or the environment. All businesses
importing or manufacturing more than 1 ton of
chemical substance per year had to preregister
between June 1 and December 1, 2008. Companies
that have filed a preregistration document for a
chemical can continue producing or importing that
substance without completing formal registration
until November 2010, May 2013, or May 2018. The
deadline depends on how much of the substance
they manufacture or import, with the earliest
deadline for higher production compounds and for
chemicals with demonstrated toxicity |