Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title

Effects on humans

20. The risk assessment shall take account of the following potential effects arising from the use of the biocidal product and the populations liable to exposure.

21. The effects previously mentioned result from the properties of the active substance and any substance of concern present. They are:

• acute and chronic toxicity,

• irritation,

• corrosivity,

• sensitisation,

• repeated dose toxicity,

• mutagenicity,

• carcinogenicity,

• reproduction toxicity,

• neurotoxicity,

• any other special properties of the active substance or substance of concern,

• other effects due to physico-chemical properties.

22. The populations previously mentioned are:

• professional users,

• non-professional users,

• humans exposed indirectly via the environment.

23. The hazard identification shall address the properties and potential adverse effects of the active substance and any substances of concern present in the biocidal product. If this results in the biocidal product being classified according to the requirements of Article 20 of this Directive then dose (concentration) — response (effect) assessment, exposure assessment and risk characterisation shall be required.

24. In those cases where the test appropriate to hazard identification in relation to a particular potential effect of an active substance or a substance of concern present in a biocidal product has been conducted but the results have not lead to classification of the biocidal product then risk characterisation in relation to that effect shall not be necessary unless there are other reasonable grounds for concern, e.g. adverse environmental effects or unacceptable residues.

25. The Member State shall apply paragraphs 26 to 29 when carrying out a dose (concentration) — response (effect) assessment on an active substance or a substance of concern present in a biocidal product.

26. For repeated dose toxicity and reproductive toxicity the dose response relationship shall be assessed for each active substance or substance of concern and, where possible, the no-observed-adverse-effect level (NOAEL) identified. If it is not possible to identify a NOAEL, the lowest-observed-adverse-effect level (LOAEL) shall be identified.

27. For acute toxicity, corrosivity and irritation, it is not usually possible to derive a NOAEL or LOAEL on the basis of tests conducted in accordance with the requirements of this Directive. For acute toxicity, the LD50 (median lethal dose) or LC50 (median lethal concentration) value or, where the fixed dose procedure has been used, the discriminating dose shall be derived. For the other effects it shall be sufficient to determine whether the active substance or substance of concern has an inherent capacity to cause such effects during use of the product.

28. For mutagenicity and carcinogenicity it shall be sufficient to determine whether the active substance or substance of concern has an inherent capacity to cause such effects during use of the biocidal product. However, if it can be demonstrated that an active substance or a substance of concern identified as a carcinogen is non-genotoxic, it will be appropriate to identify a N(L)OAEL as described in paragraph 26.

29. With respect to skin sensitisation and respiratory sensitisation, in so far as there is no consensus on the possibility of identifying a dose/concentration below which adverse effects are unlikely to occur in a subject already sensitised to a given substance, it shall be sufficient to evaluate whether the active substance or substance of concern has an inherent capacity to cause such effects during use of the biocidal product.

30. Where toxicity data derived from observations of human exposure, e.g. information gained from manufacture, from poison centres or epidemiology surveys, are available special consideration shall be given to those data when carrying out the risk assessment.

31. An exposure assessment shall be carried out for each of the human populations (professional users, non-professional users and humans exposed indirectly via the environment) for which exposure to a biocidal product occurs or can reasonably be foreseen. The objective of the assessment shall be to make a quantitative or qualitative estimate of the dose/concentration of each active substance or substance of concern to which a population is, or may be exposed during use of the biocidal product.

32. The exposure assessment shall be based on the information in the technical dossier provided in conformity with Article 8 of this Directive and on any other available and relevant information. Particular account shall be taken, as appropriate, of:

• adequately measured exposure data,

• the form in which the product is marketed,

• the type of biocidal product,

• the application method and application rate,

• the physico-chemical properties of the product,

• the likely routes of exposure and potential for absorption,

• the frequency and duration of exposure,

• the type and size of specific exposed populations where such information is available.

33. Where adequately measured, representative exposure data are available, special consideration shall be given to them when conducting the exposure assessment. Where calculation methods are used for the estimation of exposure levels, adequate models shall be applied.

These models shall:

• make a best possible estimation of all relevant processes taking into account realistic parameters and assumptions,

• be subjected to an analysis taking into account possible elements of uncertainty,

• be reliably validated with measurements carried out under circumstances relevant for the use of the model,

• be relevant to the conditions in the area of use.

Relevant monitoring data from substances with analogous use and exposure patterns or analogous properties shall also be considered.

34. Where, for any of the effects set out in paragraph 21 a NOAEL or LOAEL had been identified, the risk characterisation shall entail comparison of the NOAEL or LOAEL with the evaluation of the dose/concentration to which the population will be exposed. Where a NOAEL or LOAEL cannot be established a qualitative comparison shall be made.