Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title

ANNEX VI COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS

CONTENTS

Definitions

Introduction

Evaluation

• General principles

• Effects on humans

• Effects on animals

• Effects on the environment

• Unacceptable effects

• Efficacy

• Summary

Decision-making

• General principles

• Effects on humans

• Effects on animals

• Effects on the environment

• Unacceptable effects

• Efficacy

• Summary

Overall integration of conclusions

DEFINITIONS

(a)

Hazard identification

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

(b)

Dose (concentration) — response (effect) assessment

This is 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

This is 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

This is 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

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

INTRODUCTION

1. This Annex lays down principles to ensure that evaluations made and decisions taken by a Member State concerning the authorisation of a biocidal product providing it is a chemical preparation results in a harmonised high level of protection for humans, animals and the environment in accordance with Article 5(1)(b) of this Directive.

2. In order to ensure a high and harmonised level of protection of human and animal health and of 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 identified during the proposed normal use of the biocidal product. This is done by carrying out an assessment of the risks associated with the relevant individual components of the biocidal product.

3. A risk assessment on the active substance or substances present in the biocidal product is always required. This will already have been carried out for the purpose of Annexes I, IA or IB. 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.

4. Additional risk assessments shall be carried out, in the same manner as described above, on any other substance of concern present in the biocidal product where relevant for the use of the biocidal product.

5. In order to carry out a risk assessment data are required. These data are detailed in Annexes II, III and IV and, recognising that there are a wide variety of product types, are flexible according to the product type and associated risks. The data required shall be the minimum necessary to carry out an appropriate risk assessment. Member States should take due consideration of the requirements of Articles 12 and 13 of this Directive in order to avoid duplication of data submissions. The minimum set of data required for an active substance in any biocidal product type, however, shall be that detailed in Annex VIIA to Directive 67/548/EEC; these data will already have been submitted and assessed as part of the risk assessment required for entry of the active substance into Annex I, IA or IB to this Directive. Data may also be required on a substance of concern present in a biocidal product.

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

7. When making evaluations and taking decisions concerning the authorisation of a biocidal product the Member State shall:

(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.

8. The Member State shall comply with the requirements of mutual recognition as stated in Articles 4(1), (2) and (6) of this Directive.

9. It is known that many biocidal products present only minor differences in composition and this should be taken into account when evaluating dossiers. The concept of ‘frame-formulations’ is relevant here.

10. It is known that certain biocidal products are considered as posing only a low risk, these biocidal products, while complying with the requirements of this Annex, are subject to a simplified procedure as detailed in Article 3 of this Directive.

11. The application of these common principles shall lead to the Member State deciding whether or not a biocidal product can be authorised, such authorisation may include restrictions on use or other conditions. In certain cases the Member State may conclude that more data are required before an authorisation decision can be made.

12. During the process of evaluation and decision-making, Member States and applicants shall cooperate in order to resolve any questions on the data requirements quickly or to identify at an early stage any additional studies required, or 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 this Annex or of this Directive. The administrative burden, especially for small and medium-sized enterprises (SMEs), shall be kept to the minimum necessary without prejudicing the level of protection afforded to humans, animals and the environment.

13. The judgments made by the Member State during the evaluation and decision-making process must be based on scientific principles, preferably recognised at international level, and be made with the benefit of expert advice.

EVALUATION

General principles

14. The data submitted in support of an application for authorisation of a biocidal product shall be examined for completeness and overall scientific value by the receiving Member State. After acceptance of these data the Member State shall utilise them by carrying out a risk assessment based on the proposed use of the biocidal product.

15. 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 either of the biocidal product itself or any material treated with it.

16. For each active substance and each substance of concern present in the biocidal product, the risk assessment shall entail a hazard identification and the establishment of appropriate no-observed-adverse-effect levels (NOAEL), where possible. It shall also include, as appropriate, a dose (concentration) — response (effect) assessment, together with an exposure assessment and a risk characterisation.

17. The results arrived at from a comparison of the exposure to the no-effect level concentrations for each of the active substances and 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.

18. The risk assessment shall determine:

(a)

the risk to humans and animals,

(b)

the risk to the environment,

(c)

the measures necessary to protect humans, animals and the general environment during both 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.

Effects on humans

20. 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.

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

• acute and chronic toxicity,

• irritation,

• corrosivity,

• sensitisation,

• repeated dose toxicity,

• mutagenicity,

• carcinogenicity,

• reproduction toxicity,

• neurotoxicity,

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

• other effects due to physico-chemical properties.

22. The populations previously mentioned are:

• professional users,

• non-professional users,

• humans exposed indirectly via the environment.

23. 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. If this results in the biocidal product being classified according to the requirements of Article 20 of this Directive then dose (concentration) — response (effect) assessment, exposure assessment and risk characterisation shall be required.

24. In those cases where the test appropriate to hazard identification in relation to a particular potential effect of an active substance or a substance of concern present in a biocidal product has been conducted but the results have not lead to classification of the biocidal product then risk characterisation in relation to that effect shall not be necessary unless there are other reasonable grounds for concern, e.g. adverse environmental effects or unacceptable residues.

25. The Member State shall apply paragraphs 26 to 29 when carrying out a dose (concentration) — response (effect) assessment on an active substance or a substance of concern present in a biocidal product.

26. 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, the no-observed-adverse-effect level (NOAEL) identified. If it is not possible to identify a NOAEL, the lowest-observed-adverse-effect level (LOAEL) shall be identified.

27. 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 Directive. For acute toxicity, the LD50 (median lethal dose) or LC50 (median lethal concentration) value or, where the fixed dose procedure has been used, the discriminating dose 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 product.

28. For mutagenicity and carcinogenicity 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. However, if it can be demonstrated that an active substance or a substance of concern identified as a carcinogen is non-genotoxic, it will be appropriate to identify a N(L)OAEL as described in paragraph 26.

29. 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 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 during use of the biocidal product.

30. Where toxicity data derived from observations of human exposure, e.g. information gained from manufacture, from poison centres or epidemiology surveys, are available special consideration shall be given to those data when carrying out the risk assessment.

31. An exposure assessment shall be carried out for each of the human populations (professional users, non-professional users and humans exposed indirectly via the environment) for which exposure to a biocidal product occurs or can reasonably be foreseen. 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 to which a population is, or may be exposed during use of the biocidal product.

32. The exposure assessment shall be based on the information in the technical dossier provided in conformity with Article 8 of this Directive and on any other available and relevant information. Particular account shall be taken, as appropriate, of:

• 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 of the product,

• the likely routes of exposure and potential for absorption,

• the frequency and duration of exposure,

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

33. Where adequately measured, representative exposure data are available, special consideration shall be given to them when conducting the exposure assessment. Where calculation methods are used for the estimation of exposure levels, adequate models shall be applied.

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.

34. Where, for any of the effects set out in paragraph 21 a NOAEL or LOAEL had been identified, the risk characterisation shall entail comparison of the NOAEL or LOAEL with the evaluation of the dose/concentration to which the population will be exposed. Where a NOAEL or LOAEL cannot be established a qualitative comparison shall be made.

Effects on animals

35. Using the same relevant principles as described in the section dealing with effects on humans, the Member State shall consider the risks posed to animals from the biocidal product.

Effects on the environment

36. 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.

37. 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. If this results in the biocidal product being classified according to the requirements of this Directive then dose (concentration) — response (effect) assessment, exposure assessment and risk characterisation shall be required.

38. In those cases where the test appropriate to hazard identification in relation to a particular potential effect of an active substance or a substance of concern present in a biocidal product has been conducted but the results have not led to classification of the biocidal product then risk characterisation in relation to that effect shall not be necessary unless there are other reasonable grounds for concern. Such grounds may derive from the properties and effects of any active substance or substance of concern in the biocidal product, in particular:

• any indications of bioaccumulation potential,

• the persistence characteristics,

• the shape of the toxicity/time curve in ecotoxicity testing,

• indications of other adverse effects on the basis of toxicity studies (e.g. classification as a mutagen),

• data on structurally analogous substances,

• endocrine effects.

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 the predicted no-effect concentration (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.

40. The PNEC shall be determined from the data on effects on organisms and ecotoxicity studies submitted in accordance with requirements of Article 8 of this Directive. It shall be calculated by applying an assessment factor to the 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)).

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 is the degree of uncertainty and the size of the assessment factor.

The specifications for the assessment factors shall be elaborated in the notes for technical guidance which, to this end, shall be based particularly on the indications given in Commission Directive 93/67/EEC of 20 July 1993 laying down the principles for assessment of risks to man and environment from substances notified in accordance with Council Directive 67/548/EEC(1).

42. For each environmental compartment an exposure assessment shall be carried out in order to predict the concentration likely to be found 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.

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 material treated with biocidal products are known or are reasonably foreseeable.

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

• 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.

45. Where adequately measured, representative exposure data are available, special consideration shall be given to them when conducting the exposure assessment. 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 paragraph 33. 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.

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.

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.

Unacceptable effects

48. Data shall be submitted to and evaluated by the Member State to assess whether 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.

49. The Member State shall, where relevant, evaluate the possibility of the development of resistance to an active substance in the biocidal product by the target organism.

50. If there are indications that any other unacceptable effects may occur the Member State shall evaluate the possibility of such effects occurring. An example of such an unacceptable effect would be an adverse reaction to fastenings and fittings used in wood following the application of a wood preservative.

Efficacy

51. Data shall be submitted and evaluated to ascertain if the efficacy claims of the biocidal product can be substantiated. Data submitted by the applicant or held by the Member State 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.

52. Testing should be carried out according to Community guidelines if these are available and applicable. Where appropriate, other methods can be used as shown in the list below. If relevant acceptable field data exist, these can be used.

• ISO, CEN or other international standard method

• national standard method

• industry standard method (accepted by Member State)

• individual producer standard method (accepted by Member State)

• data from the actual development of the biocidal product (accepted by Member State).

Summary

53. In each of the areas where risk assessments have been carried out, i.e. effects on man, animals, and the environment, the Member State 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 should take account of any likely synergistic effects of the active substance(s) and substances of concern in the biocidal product.

54. For biocidal products containing more than one active substance any adverse effects shall also be combined to produce an overall effect for the biocidal product itself.

DECISION MAKING

General principles

55. Subject to paragraph 96, the Member State shall come to a decision regarding the authorisation for use of a biocidal product 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. The risk assessments shall cover normal use of the biocidal product together with a realistic worst-case scenario including any relevant disposal issue either of the biocidal product itself or any material treated with it.

56. In making a decision concerning authorisation, the Member State shall arrive at one of the following conclusions for each product type and for each area of use of the biocidal product for which application has been made:

1.

the biocidal product cannot be authorised;

2.

the biocidal product can be authorised subject to specific conditions/restrictions;

3.

more data is required before a decision on authorisation can be made.

57. If the conclusion arrived at by the Member State is that additional information or data are required before an authorisation decision can be made, then the need for any such information or data shall be justified. This additional information or data shall be the minimum necessary to carry out a further appropriate risk assessment.

58. The Member State shall comply with the principles of mutual recognition as detailed in Article 4 of this Directive.

59. The Member State shall apply the rules concerning the concept of ‘frame formulations’ when making an authorisation decision on a biocidal product.

60. The Member State shall apply the rules concerning the concept of ‘low risk’ products when making an authorisation decision on such a biocidal product.

61. The Member State shall only grant authorisation to those biocidal products which, when used according to their conditions of authorisation, do not present an unacceptable risk to humans, animals or the environment, are efficacious and which contain active substances permitted at Community level to be used in such biocidal products.

62. The Member State shall impose, where appropriate, conditions or restrictions when giving authorisations. The nature and severity of these shall be selected on the basis of, and be appropriate to, the nature and extent of the expected advantages and the risks likely to arise from the use of the biocidal product.

63. In the decision-making process the Member State shall take into consideration the following:

• the results of the risk assessment, in particular the relationship between exposure and effect,

• the nature and severity of the effect,

• the risk management which can be applied,

• the field of use of the biocidal product,

• the efficacy of the biocidal product,

• the physical properties of the biocidal product,

• the benefits of using the biocidal product.

64. The Member State shall, when taking a decision concerning the authorisation of a biocidal product, take into account the uncertainty arising from the variability in the data used in the evaluation and decision-making process.

65. The Member State shall prescribe that biocidal products shall be used properly. Proper use shall include application at an efficacious dose and minimisation of use of biocidal products where possible.

66. The Member State shall take the necessary measures to ensure that the applicant proposes a label, and, where relevant, the safety-data sheet, for the biocidal product which:

• fulfils the requirements of Articles 20 and 21 of this Directive,

• contains the information on the protection of users required by Community legislation on worker protection,

• specifies in particular the conditions or restrictions under which the biocidal product may or may not be used.

Before issuing an authorisation the Member State shall confirm that these requirements must be satisfied.

67. The Member State shall take the necessary measures to ensure that the applicant proposes packaging and, where appropriate, the procedures for destruction or decontamination of the biocidal product and its packaging or any other relevant material associated with the biocidal product, which conforms to the relevant regulatory provisions.

Effects on humans

68. The Member State shall not authorise a biocidal product if the risk assessment confirms that, in foreseeable application including a realistic worst possible scenario, the product presents an unacceptable risk to humans.

69. The Member State shall consider possible effects on all human populations, namely professional users, non-professional users and humans exposed directly or indirectly through the environment when making a decision on the authorisation of a biocidal product.

70. The Member State shall examine the relationship between the exposure and the effect, and use this in the decision-making process. A number of factors need to be considered when examining this relationship and one of the most important is the nature of the adverse effect of the substance. These effects include acute toxicity, irritancy, corrosivity, sensitisation, repeated dose toxicity, mutagenicity, carcinogenicity, neurotoxicity, reproduction toxicity together with physico-chemical properties, and any other adverse properties of the active substance or substance of concern.

71. The Member State shall, where possible, compare the results obtained with those obtained from previous risk assessments for an identical or similar adverse effect and decide on an appropriate margin of safety (MOS) when making an authorisation decision.

An appropriate MOS is typically 100 but an MOS higher or lower than this may be appropriate depending on, among other things, the nature of the critical toxicological effect.

72. The Member State shall, if appropriate, impose, as a condition of authorisation, the wearing of personal protective equipment such as respirators, breathing-masks, overalls, gloves and goggles in order to reduce exposure for professional operators. Such equipment must be readily available to them.

73. If for non-professional users the wearing of personal protective equipment would be the only possible method for reducing exposure, the product shall not normally be authorised.

74. If the relationship between the exposure and the effect cannot be reduced to an acceptable level then no authorisation can be given by the Member State for the biocidal product.

75. No biocidal product classified according to Article 20(1) of this Directive as toxic, very toxic or as a category 1 or 2 carcinogen, or as a category 1 or 2 mutagen, or classified as toxic for reproduction category 1 or 2, shall be authorised for use by the general public.

Effects on animals

76. The Member State shall not authorise a biocidal product if the risk assessment confirms that, in normal use, the biocidal product presents an unacceptable risk to non-target animals.

77. Using the same relevant criteria as described in the section dealing with effects on humans, the Member State shall consider the risks posed to animals from the biocidal product when making an authorisation decision.

Effects on the environment

78. The Member State shall not authorise a biocidal product if the risk assessment confirms that the active substance, or any substance of concern, or any degradation, or reaction product presents an unacceptable risk in any of the environmental compartments, water (including sediment), soil and air. This shall include the assessment of risks to non-target organisms in these compartments.

In considering whether there is an unacceptable risk Member States shall, when coming to a final decision in accordance with paragraph 96, take into account the criteria in paragraphs 81 to 91.

79. 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.

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.

80. 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 are necessary.

If the PEC/PNEC ratio is greater than 1 the Member State shall judge, on the basis of the size of that ratio and on other relevant factors, if further information and/or testing are required to clarify the concern or if risk reduction measures are necessary or if the product cannot be given an authorisation at all. Relevant factors to be considered are those previously mentioned in paragraph 38.

Water

81. The Member State shall not authorise a biocidal product, if under the proposed conditions of use, the foreseeable concentration of the active substance or of 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 species in the aquatic, marine or estuarine environment unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect.

82. The Member State shall not authorise a biocidal product if, under the proposed conditions of use, the foreseeable concentration of the active substance or of any other substance of concern or of relevant metabolites or breakdown or reaction products in groundwater exceeds the lower of the following concentrations:

(a)

the maximum permissible concentration laid down by Directive 80/778/EEC, or

(b)

the maximum concentration as laid down following the procedure for including the active substance in Annex I, IA or IB to this Directive, 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.

83. The Member State shall not authorise a biocidal product if 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:

• 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

  • Council Directive 75/440/EEC of 16 June 1975 concerning the quality required of surface water intended for the abstraction of drinking water in the Member States(2),

  • Directive 80/778/EEC or

• has an impact deemed unacceptable on non-target species

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

84. The proposed instructions for use of the biocidal product, including procedures for cleaning application equipment, must be such that the likelihood of accidental contamination of water or its sediments is minimised.

Soil

85. Where unacceptable contamination of soil is likely to occur, the Member State shall not authorise a biocidal product if the active substance or substance of concern contained in it, after use of the biocidal product:

• during tests in the field, persists in soil for more than one year, or

• during laboratory tests, forms non-extractable residues in amounts exceeding 70 % of the initial dose after 100 days with a mineralisation rate of less than 5 % in 100 days,

• has unacceptable consequences or effects on non-target organisms,

unless it is scientifically demonstrated that under field conditions there is no unacceptable accumulation in soil.

Air

86. The Member State shall not authorise a biocidal product where there is a foreseeable possibility of unacceptable effects on the air compartment unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect.

Effects on non-target organisms

87. The Member State shall not authorise a biocidal product 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:

• the PEC/PNEC is above 1 unless it is clearly established in the risk assessment that under field conditions no unacceptable effects occur after use of the biocidal product according to the proposed conditions of use, or

• the bioconcentration factor (BCF) related to fat tissues in non-target vertebrates is above 1 unless it is clearly established in the risk assessment that under field conditions no unacceptable effects occur, either directly or indirectly, after use of the product according to the proposed conditions of use.

88. The Member State shall not authorise a biocidal product where there is a reasonably foreseeable possibility of aquatic organisms including marine and estuarine organisms being exposed to the biocidal product if for any active substance or substance of concern in it:

• the PEC/PNEC is above 1 unless it is clearly established in the risk assessment that under field conditions the viability of aquatic organisms including marine and estuarine organisms is not threatened by the biocidal product according to the proposed conditions of use, or

• the bioconcentration factor (BCF) is greater than 1 000 for substances which are readily biodegradable or greater than 100 for those which are not readily biodegradable 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 exposed organisms including marine and estuarine organisms after use of the biocidal product according to the proposed conditions of use.

By way of derogation from this paragraph, Member States may, however, authorise an anti-fouling product used on commercial, public service and naval seagoing vessels for a period of up to 10 years from the date on which this Directive enters into force if similar fouling control cannot be achieved by other practicable means. When implementing this provision, Member States shall, if appropriate, take into account relevant International Maritime Organisation (IMO) resolutions and recommendations.

89. The Member State shall not authorise a biocidal product 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.

Unacceptable effects

90. If the development of resistance to the active substance in the biocidal product is likely the Member State shall take steps to minimise the consequences of this resistance. This may involve modification of the conditions of authorisation or even refusal of any authorisation.

91. An authorisation for a biocidal product intended to control vertebrates shall not be given unless:

• 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

92. Member States shall not authorise a biocidal product which does not possess acceptable efficacy when used in accordance with the conditions specified on the proposed label or with other conditions of authorisation.

93. 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 except where the proposed label prescribes that the biocidal product is intended for use in specific circumstances. Member States shall evaluate dose response data generated in 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.

Summary

94. In each of the areas where risk assessments have been carried out, i.e. effects on humans, animals, and the environment, the Member State shall combine the conclusions arrived at for the active substance and the substances of concern to produce an overall conclusion for the biocidal product itself. A summary should also be made of the efficacy assessment and of the unacceptable effects.

The result shall be:

• a summary of the effects of the biocidal product on humans,

• a summary of the effects of the biocidal product on animals,

• a summary of the effects of the biocidal product on the environment,

• a summary of the efficacy assessment,

• a summary of the unacceptable effects.

OVERALL INTEGRATION OF CONCLUSIONS

95. The Member State shall combine the individual conclusions arrived at with regard to effects of the biocidal product on the three sectors namely, humans, animals and the environment to arrive at an overall conclusion for the global effect of the biocidal product.

96. The Member State shall then take due consideration of any relevant unacceptable effects, the efficacy of the biocidal product and the benefits of using the biocidal product before taking an authorisation decision on the biocidal product.

97. The Member State shall ultimately decide whether or not the biocidal product can be authorised and whether this authorisation shall be subject to any restrictions or conditions in conformity with this Annex and this Directive.

(1)

OJ L 227, 8.9.1993, p. 9.

(2)

OJ L 194, 25.7.1975, p. 26. Directive as last amended by Directive 91/692/EEC (OJ L 377, 31.12.1991, p. 48).