Report from the Sub-comittee on the environment and health

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Annex 1
Data required for authorisation of pesticides
When application is made for authorisation of pesticides, <strong>the</strong> applicant
must supply <strong>the</strong> data, with appurtenant analyses, specified in Annexes
5.1 and 5.3 to Ministry of Environment and Energy Order No. 241 of 27
April 1998 on Pesticides. For substances that are new in <strong>the</strong> EU (i.e. for
which application is made after 15 June 1993), <strong>the</strong> data requirements for
<strong>the</strong> active ingredient have been slightly expanded, and for <strong>the</strong>se
pesticides, too, more information is required concerning <strong>the</strong> formulated
products. That is, however, of no relevance in this context because it
concerns only a very limited number of substances.
In <strong>the</strong> environmental area, data are required concerning some of <strong>the</strong>
active ingredient’s physical and chemical properties, its “fate” in soil and
water and its toxicity to a number of aquatic and terrestrial organisms.
The minimum information required concerning <strong>the</strong> active ingredient is
listed below.
• Physical and chemical data (that are of relevance to <strong>the</strong> environmental
risk assessment): solubility in water and organic solvents, vapour
pressure, hydrolytic stability and distribution coefficient noctanol/water.
• Metabolism and degradation in soil: photolysis on ground surface, rate
of degradation in three types of soil under aerobic conditions,
metabolism, rate of degradation at two temperatures and at two
dosages, dependence of rate of degradation on water content, rate of
degradation in sterile soil and under anaerobic conditions, evaporation
<strong>from</strong> soil (calculated on <strong>the</strong> basis of <strong>the</strong> physical and chemical
properties).
• Mobility in soil: leaching tests in soil columns with <strong>the</strong> active
ingredient, performed with three different types of soil, leaching tests
in soil columns with aged active ingredient, performed in one type of
soil, adsorption and desorption tests.
• Metabolism and degradation in water: BOD value and BOD/COD
ratio, adsorption to organic material (plankton and sediment),
accumulation in sediment (BOD = Biological Oxygen Demand; COD
= Chemical Oxygen Demand).
• Test for bioaccumulation in aquatic ecosystems if <strong>the</strong> distribution
coefficient n-octanol/water is greater than 1000.
• Toxic effect on aquatic organisms: acute toxicity in fish (2 species),
acute toxicity in daphnia (1 species), reproduction test on daphnia (1
species), acute toxicity in algae.