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

TERMS AND DEFINITIONS U.K.

Correspondence with the criteria set out in Article 19(1)(b)

The subheadings ‘Effects on human and animal health’, ‘Effects on the Environment’, ‘Effects on Target Organisms’ and ‘Efficacy’ used in the Sections ‘Assessment’ and ‘Conclusions’ correspond to the four criteria set out in Article 19(1)(b) as follows:

• ‘Efficacy’ corresponds to criterion (i): ‘is sufficiently effective’.

• ‘Effects on target organisms’ corresponds to criterion (ii): ‘has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross resistance or unnecessary suffering and pain for vertebrates’.

• ‘Effects on human and animal health’ corresponds to criterion (iii): ‘has no immediate or delayed unacceptable effects itself, or as a result of its residues, on human health, including that of vulnerable groups(1), or animal health, directly or through drinking water, food, feed, air, or through other indirect effects’.

• ‘Effects on the environment’ corresponds to criterion iv: ‘has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations:

  • its fate and distribution in the environment,

  • contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil, taking into account locations distant from its use following long-range environmental transportation,

  • its impact on non-target organisms,

  • its impact on biodiversity and the ecosystem’.

Technical definitions U.K.

(a) Hazard identification U.K.

The identification of the adverse effects which a biocidal product has an inherent capacity to cause.

(b) Dose (concentration) — response (effect) assessment U.K.

The estimate of the relationship between the dose, or level of exposure, of an active substance or substance of concern in a biocidal product and the incidence and severity of an effect.

(c) Exposure assessment U.K.

The determination of the emissions, pathways and rates of movement of an active substance or a substance of concern in a biocidal product and its transformation or degradation in order to estimate the concentration/doses to which human populations, animals or environmental compartments are or may be exposed.

(d) Risk characterisation U.K.

The estimation of the incidence and severity of the adverse effects likely to occur in a human population, animals or environmental compartments due to actual or predicted exposure to any active substance or substance of concern in a biocidal product. This may include ‘risk estimation’, i.e. the quantification of that likelihood.

(e) Environment U.K.

Water, including sediment, air, soil, wild species of fauna and flora, and any interrelationship between them, as well as any relationship with living organisms.

(1)

See definition of vulnerable groups in Article 3.