Report from the Sub-comittee on the environment and health

concentration that produces toxic effects are close to each o<strong>the</strong>r (are less
than <strong>the</strong> (un)certainty factor), <strong>the</strong> product cannot be authorised without
relevant semi-field and field tests of effects on aquatic and terrestrial
organisms that prove that use does not imply unacceptable effects on
aquatic or terrestrial organisms.
As an example, in <strong>the</strong> analysis of <strong>the</strong> risk to aquatic organisms, it is
initially assumed that watercourses are directly sprayed. If <strong>the</strong> acceptable
limit values are exceeded, PEC is modified on <strong>the</strong> basis of an assumption
that a certain distance to watercourses is maintained. In addition, <strong>the</strong>
degradation of <strong>the</strong> substance is included in <strong>the</strong> case of chronic effects and
several successive applications. If <strong>the</strong> acceptable limit values are still
exceeded, different forms of field studies, typically mesocosm tests are
included in <strong>the</strong> analysis. In such cases, <strong>the</strong> safety factor may have to be
reduced because far more species will usually be represented in field
studies and because field studies mean more realistic exposure conditions
than laboratory tests. The field studies may mean that substances judged
on <strong>the</strong> basis of laboratory tests to be unacceptable in relation to <strong>the</strong>
prescribed acceptance level are deemed acceptable on <strong>the</strong> basis of field
studies.
The conclusion of <strong>the</strong> Danish review in 1997 is that all pesticides
authorised since June 1993 fulfil <strong>the</strong> minimum requirements set out in
“Framework for Assessment of Plant Protection Products”. Products
reviewed before June 1993 are assessed in relation to <strong>the</strong> “criteria”
applying at that time, which are largely based on <strong>the</strong> substances’ inherent
properties.
2 Classification of health impacts
2.1 Classification of carcinogenicity, mutagenicity and reproduction
toxicity
Classification of substances for <strong>the</strong> above-mentioned effects are
generally based on <strong>the</strong> following considerations:
• What properties does <strong>the</strong> substance have (qualitative)?
• How well documented are <strong>the</strong>se properties?
• Are <strong>the</strong> properties of relevance to humans?
There are three categories for carcinogenicity, impairment of fertility and
mutagenicity. The categories differentiate between <strong>the</strong> reliability of <strong>the</strong>
evidence. The classification is <strong>the</strong>refore based mainly on qualitative
assessments and evidence. For <strong>the</strong>se three effect groups, <strong>the</strong> potency of
<strong>the</strong> substance is not specifically included in <strong>the</strong> assessment to decide <strong>the</strong>
category in which it is to be classified. In o<strong>the</strong>r words, <strong>the</strong> highest dose
that does not cause adverse effect levels (NOAEL) is not included in <strong>the</strong>
assessment. However, in <strong>the</strong> case of substances that are toxic for
reproduction , if <strong>the</strong> effects are only seen in very high dosages, this must
be taken into consideration when assessing whe<strong>the</strong>r <strong>the</strong> substance should
be classified at all for <strong>the</strong> effects. Reproduction toxicity covers both
damage to <strong>the</strong> foetus and impairment of fertility.
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