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Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (repealed)
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- Directives originating from the EU
- 1998 No. 8
- ANNEX VI
- EVALUATION
- General principles
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- Revised 14/05/19980.24 MB
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This is the original version (as it was originally adopted).
General principles
14.The data submitted in support of an application for authorisation of a biocidal product shall be examined for completeness and overall scientific value by the receiving Member State. After acceptance of these data the Member State shall utilise them by carrying out a risk assessment based on the proposed use of the biocidal product.
15.A risk assessment on the active substance present in the biocidal product shall always be carried out. If there are, in addition, any substances of concern present in the biocidal product then a risk assessment shall be carried out for each of these. The risk assessment shall cover the proposed normal use of the biocidal product together with a realistic worst-case scenario including any relevant production and disposal issue either of the biocidal product itself or any material treated with it.
16.For each active substance and each substance of concern present in the biocidal product, the risk assessment shall entail a hazard identification and the establishment of appropriate no-observed-adverse-effect levels (NOAEL), where possible. It shall also include, as appropriate, a dose (concentration) — response (effect) assessment, together with an exposure assessment and a risk characterisation.
17.The results arrived at from a comparison of the exposure to the no-effect level concentrations for each of the active substances and any substances of concern shall be integrated to produce an overall risk assessment for the biocidal product. Where quantitative results are not available the results of the qualitative assessments shall be integrated in a similar manner.
18.The risk assessment shall determine:
(a)
the risk to humans and animals,
(b)
the risk to the environment,
(c)
the measures necessary to protect humans, animals and the general environment during both the proposed normal use of the biocidal product and in a realistic worst-case situation.
19.In certain cases it may be concluded that further data are required before a risk assessment can be finalised. Any such additional data requested shall be the minimum necessary to complete such a risk assessment.
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