EDITORIAL
EDITORIAL
A GLOBAL LEADER IN AGRO BUSINESS R&D SERVICES
Is REACH reaching industry?
An independent Registration & Development Company specialized in Agrochem,
Biocides, Bio-pesticides and Seed products
Informa Healthcare Lifesciences are properly controlled. In addition, The survey also showed an of positive responses about
has commissioned a survey on the restrictions may be imposed on the overwhelming view that costs the impact or effort that the
SERVICES INCLUDE
REACH (Registration, Evaluation, manufacture, usage or marketing to both the producers and competent authorities have
Authorisation and Restriction of of products deemed to cause consumers will rise. In the case made in communicating the
Chemicals) legislation, the results an “unacceptable risk to human of agrochemicals, a significant REACH legislation to industry.
� Placement & Oversight of Testing (GEP/GLP) on and off site
of which are set to be published in health or the environment”. proportion of respondents – 68% Even worse, about a third of all
early 2008. For those of you who – believe that end-user prices will respondents do not know who
may not be fully up to speed on Approximately 600 people took rise as a result of REACH, while the competent authorities are.
� Program/Project Design and Management
REACH – and the survey highlights part in the survey, split between 65% of pharma respondents
that there is a good deal of the pharma (50%), agrochemical predict price increases. These For those who are in the dark
� Ecotox Studies (Lab., Semi-Field and Field)
ignorance about the legislation (25%) and other industries (25%), increases can be partly explained about REACH do not despair
– let me recap briefly what it with the respondents drawn mainly by the fact that 60% of those in – help is at hand. While the � Analytical Studies via Preferred Labs in the US, EU and Asia
encompasses. from management, sales, R&D agrochemicals believe there will authorities in individual member
and the regulatory sector. Asked be a reduction in the number of states of the EU are responsible
� Prepare/Homogenize GLP samples to be sent from EU to anywhere
After a protracted period of debate whether REACH has a negative raw materials available, as well for enforcing REACH through
and decision-making within the or positive effect, 60% of those as an increase in their costs. inspections, as well as imposing
� Provide Summary & Recommendations of Data
EU, the REACH legislation came in agrochemicals considered it penalties in the case of non-
into effect on 1 June 2007, though positive, while a whopping 80% of In terms of how well prepared compliance, the ECHA has set
� Prepare Registration Package and Deliver to Agency
most of the main provisions start pharma respondents considered it industry is to meet REACH up helpdesks in all EU countries
to apply on 1 June 2008. REACH positive. About 50% of those in the deadlines, only about one- that will be able to answer your
� Market Feasibility Assessments
radically overhauls existing EU agrochemical business believe that third of respondents appear to questions about REACH – see
chemcials’ legislation, requiring REACH will attain its goals, with be on track. Roughly another http://echa.europa.eu/reach/
all manufacturers and importers of 45% in pharma agreeing. third is in the throes of waking helpdesk. It is important for
chemicals to identify and manage up to REACH and realising the companies to learn as much as
risks linked to substances they Optimism regarding the positive requirements it is demanding. possible about REACH as, given
manufacture and market. In a outcomes of REACH, however, was While the remainder know or care the huge number of chemical
radical departure from the previous found to increase in proportion little about REACH and its impact. substances governed by it, its
status quo, it effectively places to how far a respondent was from However, the trend is one where economic and environmental
the burden of proof regarding the the front line of engagement in those who are most aware of impacts should not be
safety of products back on industry, the REACH preparations. The REACH work in sectors likely to underestimated. Ignorance now
requiring companies to produce a high percentage of positivity be affected or regulated early. will mean pain later! Representative Offices – USA, France, UK, Spain, Portugal, Italy, Austria, Belgium,
registration dossier, which must in the pharma business may
Hungary, South Africa, Japan, South Korea, Philippines, Chile and Argentina
be submitted to the European well reflect an industry already For industries used to dealing Nessa Keogh
Chemicals Agency (ECHA), showing extremely highly regulated with regulatory authorities, Editor
that their products are safe. – pharma companies in the UK, there is a “worrying” low level
AMERICAS EU & ASIA
for instance, are now required
Khosro Khodayari Paul French
The European Commission, to provide health technology
+1 530 753-8880 ++444 1647 252721
meanwhile, is currently reviewing assessments (HTAs) which very ‘REACH out 2007’, the REACH industry survey, will
khosro@syntechresearch.com pfrench@syntechresearcchh.com
several REACH annexes and, clearly show regulators the be published in January 2008 and will be available
furthermore, will establish an efficacy and safety of a drug. free of charge on www.agrow.com
www.syntechresearch.com
authorisation system to ensure that It’s likely that HTAs will be
substances of very high concern imposed Europe-wide eventually.
 January 008 • www.agrow.com
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