Effects on human and animal health

The evaluating body shall consider possible effects on all human populations, namely professional users, non-professional users and humans exposed directly or indirectly through the environment. In reaching these conclusions, particular attention shall be paid to vulnerable groups among the different populations. The evaluating body shall examine the relationship between exposure and effect. A number of factors need to be considered when examining this relationship. One of the most important factors is the nature of the adverse effect of the substance under consideration. These effects include acute toxicity, irritancy, corrosivity, sensitisation, repeated dose toxicity, mutagenicity, carcinogenicity, neurotoxicity, immunotoxicity, reproductive toxicity, disruption of the endocrine system together with physico-chemical properties, and any other adverse properties of the active substance or substance of concern, or of their relevant metabolites or degradation products. Typically, the margin of exposure (MOE_(ref)) — the ratio between the dose descriptor and the exposure concentration — is in the region of 100, but a MOE_(ref) that is higher or lower than this may also be appropriate depending on, among other things, the nature of the critical effects and the sensitivity of the population. The evaluating body shall, where appropriate, conclude that criterion (iii) under point (b) of Article 19(1) can only be complied with by application of prevention and protection measures including the design of work processes, engineering controls, use of adequate equipment and materials, application of collective protection measures and, where exposure cannot be prevented by other means, application of individual protection measures including the wearing of personal protective equipment such as respirators, breathing-masks, overalls, gloves and goggles, in order to reduce exposure for professional operators. If, for non-professional users, the wearing of personal protective equipment would be the only possible method for reducing exposure to an acceptable level for this population, the product shall not normally be considered as complying with criterion (iii) under point (b) of Article 19(1) for this population. Using the same relevant criteria as described in the section dealing with effects on human health, the evaluating body shall consider whether criterion (iii) under point (b) of Article 19(1) is complied with for animal health.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.