Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

Effects on human and animal health U.K.

Effects on human health U.K.

22. 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. U.K.

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

• acute toxicity,

• irritation,

• corrosivity,

• sensitisation,

• repeated dose toxicity,

• mutagenicity,

• carcinogenicity,

• reproductive toxicity,

• neurotoxicity,

• immunotoxicity,

• disruption of the endocrine system,

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

• other effects due to physico-chemical properties.

24. The populations previously mentioned are: U.K.

• professional users,

• non-professional users,

• humans exposed directly or indirectly via the environment.

In considering these populations, particular attention should be given to the need to protect vulnerable groups within these populations.

25. 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. U.K.

26. The evaluating body shall apply points 27 to 30 when carrying out a dose (concentration) - response (effect) assessment on an active substance or a substance of concern present in a biocidal product. U.K.

27. 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, a NOAEL identified. If it is not possible to identify a NOAEL, the lowest-observed-adverse-effect level (LOAEL) shall be identified. Where appropriate, other dose-effect descriptors may be used as reference values. U.K.

28. 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 Regulation. For acute toxicity, the LD₅₀ (median lethal dose) or LC₅₀ (median lethal concentration) value or another appropriate dose-effect descriptor 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 biocidal product. U.K.

29. For mutagenicity and carcinogenicity, a non-threshold assessment should be carried out if the active substance or substance of concern is genotoxic and carcinogenic. If the active substance or a substance of concern is not genotoxic a threshold assessment shall be carried out. U.K.

30. 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, particularly 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 as a result of the use of the biocidal product. U.K.

31. When carrying out the risk assessment special consideration shall be given to toxicity data derived from observations of human exposure where such data are available, e.g. information gained from manufacture, from poison centres or epidemiology surveys. U.K.

32. An exposure assessment shall be carried out for each of the human populations (professional users, non-professional users and humans exposed directly or indirectly via the environment), for which exposure to a biocidal product occurs or can reasonably be foreseen, with particular attention paid to the pathways of exposure relevant for vulnerable groups. 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, including relevant metabolites and degradation products to which a population is, or may be exposed during use of the biocidal product and articles treated with that product. U.K.

33. The exposure assessment shall be based on the information in the technical dossier provided in conformity with Articles 6 and 21 and on any other available and relevant information. Particular account shall be taken, as appropriate, of: U.K.

• adequately measured exposure data,

• the form in which the biocidal product is marketed,

• the type of biocidal product,

• the application method and application rate,

• the physico-chemical properties of the biocidal product,

• the likely routes of exposure and potential for absorption,

• the frequency and duration of exposure,

• maximum residue levels,

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

34. When conducting the exposure assessment, special consideration shall be given to adequately measured, representative exposure data where such data are available. Where calculation methods are used for the estimation of exposure levels, adequate models shall be applied. U.K.

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.

35. Where, for any of the effects set out in point 23 a reference value has been identified, the risk characterisation shall entail comparison of the reference value with the evaluation of the dose/concentration to which the population will be exposed. Where a reference value cannot be established a qualitative approach shall be used. U.K.

Assessment factors account for the extrapolation from animal toxicity to the exposed human population. The setting of an overall assessment factor considers the degree of uncertainty in inter-species and intra-species extrapolation. In the absence of suitable chemical-specific data, a default assessment factor of 100 is applied to the relevant reference value. Additional elements can also be considered for assessment factors, including toxicokinetics and toxicodynamics, the nature and severity of the effect, human (sub-)populations, exposure deviations between study results and human exposure with regard to frequency and duration, study duration extrapolation (e.g. sub-chronic to chronic), dose-response relationship and the overall quality of the toxicity data package.

Effects on animal health U.K.

36. Using the same relevant principles as described in the section dealing with effects on humans, the evaluating body shall consider the risks posed to animals from the biocidal product. U.K.