Brussels, Belgium
January 31, 2007
Source:
Perspectives on crop protection & crop science
A briefieng for policymakers from the
European Crop Protection
Association
REACH – the new regulation for
Registration, Evaluation and Authorisation of CHemicals – has
finally been adopted formally into EU law. After a compromise
agreement was worked out between the Commission, Parliament and
Council at the end of November, the final text was passed by a
large majority in Parliament on 13th December and finally
approved by the Council of Ministers on 18th. It now comes into
effect in June this year.
The main provisions
Manufacturers and importers of some 30,000 chemicals used in a
wide range of products will have to provide health and safety
data for them to permit their continued use, even though they
may have been in general safe use for many years. This will
introduce a further burden on industry and result in a
considerably larger amount of animal testing. All the chemicals
will have to be submitted and approved over an 11-year period by
a new chemicals agency to be set up in Helsinki. Prioritisation
will be on the basis of known toxicity and volume used.
Why is this a problem for the plant protection industry?
The intention of REACH is that all chemicals will fall under a
common framework for assessment, rather than remain covered by a
large number of pieces of separate legislation. At the same
time, it introduces a requirement for all chemicals already in
use before current safety legislation was enacted to be formally
registered and approved. This is why such a large number of
compounds will have to be assessed.
Of course, if compounds are already adequately dealt with via
existing legislation, their inclusion in REACH serves no
additional purpose, and adds considerable costs. All plant
protection products are already subject to stringent safety
assessment before approval under Directive 91/414. This covers
not only the active ingredients but also the so-called
co-formulants, which are compounds such as surfactants which
improve the efficiency of use of the active ingredients
themselves. During the drafting of the new REACH regulation, it
was intended that all components of plant protection products –
co-formulants as well as active ingredients – should be exempt
to avoid unnecessary duplicate testing.
However, the relevant part of the regulation (Article 15) was
drafted in such a way that co-formulants would still require
registration. Despite the proposal of the Commission to change
the wording of Art 15, Council and Parliament did not see this
as a high priority issue in the context of a complex, major
piece of new legislation. Therefore, it has unfortunately not
been corrected, and this requirement will come into force as
part of the overall REACH package in June. At the same time, a
separate Article (17) would potentially trigger a need for
intermediates in pesticides manufacture – themselves never
leaving the factory – to go through the full registration
process, introducing a further unnecessary burden.
Next steps
As for all complex legislation, full implementation can itself
be a lengthy process and, in this case, there are specific REACH
Implementation Programmes (RIPs) which are intended to give
guidance on the actual implementation of the new regulation.
ECPA will play an active part in helping to further clarify the
actual implementation of the provisions mentioned above.
Learn more about REACH or to view the Regulation itself on the
European Commission’s REACH introduction page:
http://ec.europa.eu/environment/chemicals/reach/reach_intro.htm |