Regulation (EU) No 528/2012 of the European Parliament and of the CouncilDangos y teitl llawn

CONCLUSIONS U.K.

General principles U.K.

55. The purpose of the evaluation is to establish whether or not the product complies with the criteria set down in point (b) of Article 19(1). The evaluating body shall reach its conclusion as a result of the integration of the risks arising from each active substance together with the risks from each substance of concern present in the biocidal product, based on the assessment carried out in accordance with points 13 to 54 of this Annex. U.K.

56. In establishing compliance with the criteria set out in point (b) of Article 19(1), the evaluating body shall arrive at one of the following conclusions for each product-type and each area of use of the biocidal product for which application has been made: U.K.

(1)

that the biocidal product complies with the criteria;

(2)

that, subject to specific conditions/restrictions, the biocidal product can comply with the criteria;

(3)

that it is not possible, without additional data, to establish if the biocidal product complies with the criteria;

(4)

that the biocidal product does not comply with the criteria.

57. The evaluating body shall, when seeking to establish whether a biocidal product complies with the criteria in point (b) of Article 19(1), take into account uncertainty arising from the variability in the data used in the evaluation process. U.K.

58. If the conclusion arrived at by the evaluating body is that additional information or data are required, then the evaluating body shall justify the need for any such information or data. This additional information or data shall be the minimum necessary to carry out a further appropriate risk assessment. U.K.

Effects on human and animal health U.K.

Effects on human health U.K.

59. 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. U.K.

60. 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. U.K.

61. 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. U.K.

62. 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. U.K.

63. 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. U.K.

Effects on animal health U.K.

64. 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. U.K.

Effects on the environment U.K.

65. The basic tool used in the decision-making is the PEC/PNEC ratio or, if this is not available, a qualitative estimation. Due consideration shall be given to the accuracy of this ratio due to variability in the data used both in measurements of concentration and of estimation. U.K.

In the determination of the PEC, the most appropriate model should be used taking into account the environmental fate and behaviour of the biocidal product.

66. For any given environmental compartment, if the PEC/PNEC ratio is equal to or less than 1, the risk characterisation shall be that no further information and/or testing is necessary. If the PEC/PNEC ratio is greater than 1, the evaluating body shall judge, on the basis of the size of that ratio and on other relevant factors, whether further information and/or testing is required to clarify the concern or appropriate risk reduction measures are necessary, or whether the biocidal product cannot comply with criterion (iv) under point (b) of Article 19(1). U.K.

Water U.K.

67. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where, under the proposed conditions of use, the foreseeable concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products in water (or its sediments) has an unacceptable impact on non-target organisms in the aquatic, marine or estuarine environment, unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect. In particular, the evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1), where under the proposed conditions of use, the foreseeable concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products in water (or its sediments), would undermine the achievement of compliance with the standards laid down in: U.K.

• Directive 2000/60/EC,

• Directive 2006/118/EC,

• Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy(1),

• Directive 2008/105/EC, or

• international agreements on the protection of river systems or marine waters from pollution.

68. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where, under the proposed conditions of use, the foreseeable concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products in groundwater, exceeds the lower of the following concentrations: U.K.

• the maximum permissible concentration laid down by Directive 98/83/EC, or

• the maximum concentration as laid down following the procedure for approving the active substance under this Regulation, on the basis of appropriate data, in particular toxicological data,

unless it is scientifically demonstrated that under relevant field conditions the lower concentration is not exceeded.

69. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where the foreseeable concentration of the active substance or a substance of concern, or of relevant metabolites, breakdown or reaction products to be expected in surface water or its sediments after use of the biocidal product under the proposed conditions of use: U.K.

• exceeds, where the surface water in or from the area of envisaged use is intended for the abstraction of drinking water, the values fixed by:

  • Directive 2000/60/EC,

  • Directive 98/83/EC, or

• has an impact deemed unacceptable on non-target organisms,

unless it is scientifically demonstrated that under relevant field conditions this concentration is not exceeded.

70. The proposed instructions for use of the biocidal product, including procedures for cleaning application equipment, must be such that, if followed, they minimise the likelihood of accidental contamination of water or its sediments. U.K.

Soil U.K.

71. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where, under the proposed conditions of use, the foreseeable concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products in soil, has an unacceptable impact on non-target species, unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect. U.K.

Air U.K.

72. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) of point (b) of Article 19(1) where there is a reasonably foreseeable possibility of unacceptable effect on the air compartment, unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect. U.K.

Non-target organisms U.K.

73. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where there is a reasonably foreseeable possibility of non-target organisms being exposed to the biocidal product, if for any active substance or substance of concern: U.K.

• the PEC/PNEC is above 1, or

• the concentration of the active substance or any other substance of concern, or of relevant metabolites or breakdown or reaction products, has an unacceptable impact on non-target species, unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect.

74. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) where there is a reasonably foreseeable possibility of micro-organisms in sewage treatment plants being exposed to the biocidal product, if for any active substance, substance of concern, relevant metabolite, breakdown or reaction product the PEC/PNEC ratio is above 1, unless it is clearly established in the risk assessment that under field conditions no unacceptable impact, either directly or indirectly, occurs on the viability of such micro-organisms. U.K.

Effects on target organisms U.K.

75. Where the development of resistance or cross-resistance to the active substance in the biocidal product is likely, the evaluating body shall consider actions to minimise the consequences of this resistance. This may involve modification of the conditions under which an authorisation is given. However, where the development of resistance or cross-resistance cannot be reduced sufficiently, the evaluating authority shall conclude that the biocidal product does not satisfy criterion (ii) under point (b) of Article 19(1). U.K.

76. A biocidal product intended to control vertebrates shall not normally be regarded as satisfying criterion (ii) under point (b) of Article 19(1) unless: U.K.

• death is synchronous with the extinction of consciousness, or

• death occurs immediately, or

• vital functions are reduced gradually without signs of obvious suffering.

For repellent products, the intended effect shall be obtained without unnecessary suffering and pain for the target vertebrate.

Efficacy U.K.

77. The level, consistency and duration of protection, control or other intended effects must, as a minimum, be similar to those resulting from suitable reference products, where such products exist, or to other means of control. Where no reference products exist, the biocidal product must give a defined level of protection or control in the areas of proposed use. Conclusions as to the performance of the biocidal product must be valid for all areas of proposed use and for all areas in the Member State or, where appropriate, in the Union, except where the biocidal product is intended for use in specific circumstances. The evaluating body shall evaluate dose-response data generated in appropriate trials (which must include an untreated control) involving dose rates lower than the recommended rate, in order to assess if the recommended dose is the minimum necessary to achieve the desired effect. U.K.

Summary U.K.

78. In relation to the criteria set out in points (iii) and (iv) of Article 19(1)(b), the evaluating body shall combine the conclusions arrived at for the active substance(s) and the substances of concern to produce overall summary conclusions for the biocidal product itself. A summary of the conclusions in relation to the criteria set out in points (i) and (ii) of Article 19(1)(b) shall also be made. U.K.

(1)

OJ L 164, 25.6.2008, p. 19.