Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (Text with EEA relevance) (c. 528)

ANNEX VI U.K. COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS

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.

INTRODUCTION U.K.

1. This Annex sets out the common principles for the evaluation of dossiers for biocidal products referred to in Article 19(1)(b). A decision by a Member State or the Commission to authorise a biocidal product shall be taken on the basis of the conditions set down in Article 19, taking account of the evaluation carried out according to this Annex. Detailed technical guidance regarding the application of this Annex is available on the website of the Agency. U.K.

2. The principles set out in this Annex can be applied in their entirety to the evaluation of biocidal products comprised of chemical substances. For biocidal products containing micro-organisms, these principles should be further developed in technical guidance taking into account practical experience gained, and be applied taking into account the nature of the product and the latest scientific information. In the case of biocidal products containing nanomaterials, the principles set out in this Annex will also need to be adapted and elaborated in technical guidance to take account of the latest scientific information. U.K.

3. In order to ensure a high and harmonised level of protection of human health, animal health and the environment, any risks arising from the use of a biocidal product shall be identified. To achieve this, a risk assessment shall be carried out to determine the acceptability or otherwise of any risks that are identified. This is done by carrying out an assessment of the risks associated with the relevant individual components of the biocidal product, taking into account any cumulative and synergistic effects. U.K.

4. A risk assessment on the active substance(s) present in the biocidal product is always required. This risk assessment shall entail hazard identification, and, as appropriate, dose (concentration) - response (effect) assessment, exposure assessment and risk characterisation. Where a quantitative risk assessment cannot be made a qualitative assessment shall be produced. U.K.

5. Additional risk assessments shall be carried out, in the same manner as described above, on any substance of concern present in the biocidal product. Information submitted in the framework of Regulation (EC) No 1907/2006 shall be taken into account where appropriate. U.K.

6. In order to carry out a risk assessment, data are required. These data are detailed in Annexes II and III and take account of the fact that there are a wide variety of applications as well as different product-types and that this has an impact on the associated risks. The data required shall be the minimum necessary to carry out an appropriate risk assessment. The evaluating body shall take due consideration of the requirements of Articles 6, 21 and 62 in order to avoid duplication of data submissions. Data may also be required on a substance of concern present in a biocidal product. For in-situ generated active substances, the risk assessment includes also the possible risks from the precursor(s). U.K.

7. The results of the risk assessments carried out on the active substance and on the substances of concern present in the biocidal product shall be integrated to produce an overall assessment for the biocidal product itself. U.K.

8. When making evaluations of a biocidal product the evaluating body shall: U.K.

(a)

take into consideration other relevant technical or scientific information which is reasonably available to them with regard to the properties of the biocidal product, its components, metabolites, or residues;

(b)

evaluate, where relevant, justifications submitted by the applicant for not supplying certain data.

9. The application of these common principles shall, when taken together with the other conditions set out in Article 19, lead to the competent authorities or the Commission deciding whether or not a biocidal product can be authorised. Such authorisation may include restrictions on use or other conditions. In certain cases the competent authorities may conclude that more data are required before an authorisation decision can be made. U.K.

10. In the case of biocidal products containing active substances covered by the exclusion criteria in Article 5(1), the competent authorities or the Commission shall also evaluate whether the conditions of Article 5(2) can be satisfied. U.K.

11. During the process of evaluation, applicants and the evaluating bodies shall cooperate in order to resolve quickly any questions on the data requirements, to identify at an early stage any additional studies required, to amend any proposed conditions for the use of the biocidal product, or to modify its nature or its composition in order to ensure full compliance with the requirements of Article 19 and of this Annex. The administrative burden, especially for SMEs, shall be kept to the minimum necessary without prejudicing the level of protection afforded to humans, animals and the environment. U.K.

12. The judgments made by the evaluating body during the evaluation must be based on scientific principles, preferably recognised at international level, and must be made with the benefit of expert advice. U.K.

ASSESSMENT U.K.

General principles U.K.

13. The data submitted in support of an application for authorisation of a biocidal product shall be validated by the evaluating or receiving competent authority in accordance with the relevant articles of the Regulation. After validation of these data the competent authorities shall utilise them by carrying out a risk assessment based on the proposed use. Information submitted in the framework of Regulation (EC) No 1907/2006 shall be taken into account where appropriate. U.K.

14. A risk assessment on the active substance present in the biocidal product shall always be carried out. If there are, in addition, any substances of concern present in the biocidal product then a risk assessment shall be carried out for each of these. The risk assessment shall cover the proposed normal use of the biocidal product, together with a realistic worst-case scenario including any relevant production and disposal issue. The assessment shall also take account of how any ‘treated articles’ treated with or containing the product may be used and disposed of. Active substances that are generated in-situ and the associated precursors shall also be considered. U.K.

15. In carrying out the assessment, the possibility of cumulative or synergistic effects shall also be taken into account. The Agency shall, in collaboration with the Commission, Member States and interested parties, develop and provide further guidance on the scientific definitions and methodologies for the assessment of cumulative and synergistic effects. U.K.

16. For each active substance and each substance of concern present in the biocidal product, the risk assessment shall entail hazard identification and the establishment of appropriate reference values for dose or effect concentrations such as NOAEL or Predicted No Effect Concentrations (PNEC), where possible. It shall also include, as appropriate, a dose (concentration) — response (effect) assessment, together with an exposure assessment and a risk characterisation. U.K.

17. The results arrived at from a comparison of the exposure to the appropriate reference values for each of the active substances and for any substances of concern shall be integrated to produce an overall risk assessment for the biocidal product. Where quantitative results are not available the results of the qualitative assessments shall be integrated in a similar manner. U.K.

18. The risk assessment shall determine: U.K.

(a)

the hazards due to the physico-chemical properties,

(b)

the risk to humans and animals,

(c)

the risk to the environment,

(d)

the measures necessary to protect humans, animals and the environment, both during the proposed normal use of the biocidal product and in a realistic worst-case situation.

19. In certain cases it may be concluded that further data are required before a risk assessment can be finalised. Any such additional data requested shall be the minimum necessary to complete such a risk assessment. U.K.

20. The information provided on the biocidal product family shall permit the evaluating body to reach a decision on whether all the products within the biocidal product family comply with the criteria under Article 19(1)(b). U.K.

21. Where relevant the technical equivalence for every active substance contained in the biocidal product shall be established with reference to active substances already included in the list of approved active substances. U.K.

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.

Effects on the environment U.K.

37. The risk assessment shall take account of any adverse effects arising in any of the three environmental compartments — air, soil and water (including sediment) — and of the biota, following the use of the biocidal product. U.K.

38. 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.

39. A dose (concentration) — response (effect) assessment shall be carried out in order to predict the concentration below which adverse effects in the environmental compartment of concern are not expected to occur. This shall be carried out for the active substance and for any substance of concern present in the biocidal product. This concentration is known as PNEC. However, in some cases, it may not be possible to establish a PNEC and a qualitative estimation of the dose (concentration) — response (effect) then has to be made. U.K.

40. The PNEC shall be determined from the data on effects on organisms and ecotoxicity studies submitted in accordance with requirements of Articles 6 and 20. It shall be calculated by applying an assessment factor to the reference values resulting from tests on organisms, e.g. LD₅₀ (median lethal dose), LC₅₀ (median lethal concentration), EC₅₀ (median effective concentration), IC₅₀ (concentration causing 50 % inhibition of a given parameter, e.g. growth), NOEL(C) (no-observed-effect level (concentration)), or LOEL(C) (lowest-observed-effect level (concentration)). Where appropriate, other dose-effect descriptors may be used as reference values. U.K.

41. An assessment factor is an expression of the degree of uncertainty in extrapolation from test data on a limited number of species to the real environment. Therefore, in general, the more extensive the data and the longer the duration of the tests, the smaller the degree of uncertainty and the size of the assessment factor. U.K.

42. For each environmental compartment, an exposure assessment shall be carried out in order to predict the likely concentration of each active substance or substance of concern present in the biocidal product. This concentration is known as the predicted environmental concentration (PEC). However, in some cases it may not be possible to establish a PEC and a qualitative estimate of exposure then has to be made. U.K.

43. A PEC, or where necessary a qualitative estimate of exposure, need only be determined for the environmental compartments to which emissions, discharges, disposal or distributions (including any relevant contribution from articles treated with biocidal products) are known or are reasonably foreseeable. U.K.

44. The PEC, or the qualitative estimation of exposure, shall be determined taking account of, in particular and where appropriate: U.K.

• 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,

• breakdown/transformation products,

• likely pathways to environmental compartments and potential for adsorption/desorption and degradation,

• the frequency and duration of exposure,

• long range environmental transportation.

45. 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. The characteristics of these models shall be as listed in point 34. Where appropriate, on a case-by-case basis, relevant monitoring data from substances with analogous use and exposure patterns or analogous properties should also be considered. U.K.

46. For any given environmental compartment, the risk characterisation shall, as far as possible, entail comparison of the PEC with the PNEC so that a PEC/PNEC ratio may be derived. U.K.

47. If it has not been possible to derive a PEC/PNEC ratio, the risk characterisation shall entail a qualitative evaluation of the likelihood that an effect is occurring under the current conditions of exposure or will occur under the expected conditions of exposure. U.K.

48. The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 19(1) if it contains any substance of concern or relevant metabolites or breakdown or reaction products fulfilling the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006, or if it has endocrine-disrupting properties unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect. U.K.

Effects on target organisms U.K.

49. An assessment shall be made to demonstrate that the biocidal product does not cause unnecessary suffering in its effect on target vertebrates. This shall include an evaluation of the mechanism by which the effect is obtained and the observed effects on the behaviour and health of the target vertebrates; where the intended effect is to kill the target vertebrate, the time necessary to obtain the death of the target vertebrate and the conditions under which death occurs shall be evaluated. U.K.

50. The evaluating body shall, where relevant, evaluate the possibility of the development by the target organism of resistance or cross-resistance to an active substance in the biocidal product. U.K.

Efficacy U.K.

51. Data submitted by the applicant shall be sufficient to substantiate the efficacy claims for the product. Data submitted by the applicant or held by the evaluating body must be able to demonstrate the efficacy of the biocidal product against the target organism when used normally in accordance with the conditions of authorisation. U.K.

52. Testing should be carried out according to Union guidelines where these are available and applicable. Where appropriate, other methods from the list below can be used. If relevant acceptable field data exist, these can be used. U.K.

• ISO, CEN or other international standard method

• national standard method

• industry standard method (if accepted by the evaluating body)

• individual producer standard method (if accepted by the evaluating body)

• data from the actual development of the biocidal product (if accepted by the evaluating body).

Summary U.K.

53. In each of the areas where risk assessments have been carried out, the evaluating body shall combine the results for the active substance together with the results for any substance of concern to produce an overall assessment for the biocidal product itself. This shall also take account of any cumulative or synergistic effects. U.K.

54. For biocidal product containing more than one active substance, any adverse effects shall also be considered together to produce an overall assessment for the biocidal product itself. U.K.

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(2),

• 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.

OVERALL INTEGRATION OF CONCLUSIONS U.K.

The evaluating body shall, on the basis of the evaluation carried out in accordance with the principles set down in this Annex, come to a conclusion as to whether or not it is established that the biocidal product complies with the criteria laid down under point (b) of Article 19(1).

(1)

See definition of vulnerable groups in Article 3.

(2)

OJ L 164, 25.6.2008, p. 19.