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Cleaner Technology Projects in Denmark 1996
Impact of Regulation on the Development of Biotechnology
Impact of Regulation on the Development of Biotechnology
Miljørapport nr. 322, 1996, Miljøstyrelsen
Growing concern with the adverse effects on human health and the environment from the
use of chemical crop protection agents has brought about a tightening of the demands for
product authorisation and risk assessments in Denmark and the EU in recent years. At the
same time Denmark has issued bans on the use of certain substances and products, while
taxes have been imposed on other products on the market. Between them the three
initiatives are intended to contribute towards a reduction of the consumption of chemical
agents while at the same time such consumption as does take place involves no unnecessary
risk to people and the environment.
Chemical products are thus facing a serious impairment of their position in the
marketplace. Bans and taxes have a particularly adverse impact on the market whereas, on
the other hand, enhanced authorisation demands do not seem to have any crucial influence
in the light of the agro-chemical enterprises’ total costs of developing a new crop
protection agent.
In parallel with this, demands have been introduced for product authorisation and risk
assessment of microbiological crop protection agents. This renders enterprises within this
area liable to costs that weaken the products’ possibilities on the market in the
short term. The reason is that the costs of risk assessment are relatively high for these
products in view of the comparatively narrow market that the products typically address.
At first glance, the introduction of this weakening may seem paradoxical - bearing in
mind that microbiological agents are generally regarded as environmentally favourable. In
the longer term, however, there may be prospects of a professionalisation of the market
resulting in enhanced recognition of the products.
Exemption from taxes, subsidies for research, and the introduction of rules of priority
for the authorisation of products may, added together, promote the development and
increase the business community’s incentives within the area.
In the field of plant breeding the development of transgenic plants represents a new
option. One may fear that the introduction of risk assessments and authorisation
requirements will hamper the development in the area, but Danish experience does not seem
to support this. The costs of risk assessment are not on such a scale as to have any
influence compared with the overall costs of developing a transgenic plant.
Overall, the market for chemical crop protection agents is being curtailed. The market
for microbiological agents will be weakened in the short term but strengthened in the
longer term by virtue of the weakening of the position of the chemical products as well as
by virtue of various stimulative policy initiatives. The development of transgenic plants
is not hampered by regulation and favourable possibilities are predicted for them -
notably in the light of the difficulties faced by the chemical agents.
The impact of regulation on the possibilities of biotechnological products is generally
favourable by virtue of the stimulative initiatives for the biotechnological products and
restraining measures for the competing chemical products.
The crucial factor for the development in biotechnological applications within the
field of crop protection is not environmental regulation or risk assessments. It is the
regulation in terms of ongoing agricultural policy, first and foremost, under the auspices
of the common agricultural policy in the EU, and the interaction this policy has with the
market. The impact of this on the choice of crop, pest protection strategy, and technology
and product development in the field of crop protection is significantly greater than the
environmental regulation.
Author/ institution
Morten Kvistgaard, BioBusiness Consult ApS
This report is subsidised by the National Council for Recycling and Cleaner Production
ISSN no. 87-7810-571-4
ISBN no. 0105-3094
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