Directive 98/8/EC of the European Parliament and of the Council (repealed)Show full title

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(1),

  • 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.

(1)

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).