Diario Oficial de la Unión Europea del 13/6/2023 - Sección Legislación
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Fuente: Diario Oficial de la Unión Europea - Sección Legislación
L 152/24
EN
Official Journal of the European Union
13.6.2023
23
The risk of primary and secondary poisoning of animals due to the use of biocidal products containing alphachloralose, the differences in the occurrence of primary and secondary poisoning incidents among Member States and the necessary risk mitigation measures to be applied to reduce that risk to an acceptable level should be also assessed in the context of the evaluation of the application for renewal of the approval of alphachloralose and should subsequently be duly taken into account by Member States in the authorisation of biocidal products containing alphachloralose.
24
The Commission therefore considers that risk mitigation measures to address the risk of primary and secondary poisoning from the use of the biocidal product should, exceptionally, until the conclusion of the evaluation of the application for renewal of the approval of alphachloralose, take into account the particular circumstances and available scientifically validated evidence of the occurrence of primary and secondary poisoning incidents in the individual Member States.
25
On 26 October 2022, the Commission provided the authorisation holder with the opportunity to provide written comments in accordance with Article 362 of Regulation EU No 528/2012. The authorisation holder provided comments, which the Commission subsequently considered.
26
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS DECISION:
Article 1
The biocidal product identified by the asset numbers in the Register for Biocidal Products BE-0003002-0000, CH-0009788-0000, DE-0011801-0000, DK-0007141-0000, FR-0005302-0000, IE-0007441-0000, IT-0012826-0000, NL-0005019-0000, PT-0010276-0000 does not fully meet the conditions laid down in Article 191, point biii, of Regulation EU No 528/2012.
The biocidal product may only be authorised in accordance with Article 195 of Regulation EU No 528/2012 in Member States who consider that not authorising it would result in disproportionate negative impacts for society when compared to the risks to human health, animal health or the environment arising from the use of the biocidal product under the conditions laid down in the authorisation.
The use of the biocidal product shall be subject to appropriate risk mitigation measures, as referred to in Article 195 of Regulation EU No 528/2012, which in each Member State shall be adopted based on the particular circumstances and available evidence of the occurrence of secondary poisoning incidents in that Member State.
Article 2
This Decision is addressed to the Member States.
Done at Brussels, 9 June 2023.
For the Commission Stella KYRIAKIDES
Member of the Commission
