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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)
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In establishing compliance with the criteria set out in point (b) of Article 19(1), the [F2competent authority] 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:
that the biocidal product complies with the criteria;
that, subject to specific conditions/restrictions, the biocidal product can comply with the criteria;
that it is not possible, without additional data, to establish if the biocidal product complies with the criteria;
that the biocidal product does not comply with the criteria.
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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.
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The [F10competent authority] 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 [F10competent authority] 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:
Directive 2000/60/EC,
Directive 2006/118/EC,
Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy(1),
Directive 2008/105/EC, or
international agreements on the protection of river systems or marine waters from pollution.
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The [F11competent authority] 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:
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,
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unless it is scientifically demonstrated that under relevant field conditions the lower concentration is not exceeded.
The [F12competent authority] 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:
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,
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unless it is scientifically demonstrated that under relevant field conditions this concentration is not exceeded.
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The [F15competent authority] 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:
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.
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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.
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F19Words in Annex 6 para. 77 substituted (31.12.2020) by S.I. 2019/720, Sch. 2 para. 143(14) (as substituted by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1567), reg. 1(2), Sch. 2 para. 39(b))
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