L 152/14
EN
Official Journal of the European Union
13.6.2023
(7)
On 6 June 2020, the secretariat of the coordination group invited the other concerned Member States and the authorisation holder to submit written comments on the referral.
The authorisation holder submitted written comments on 30 June 2020, 6 July 2020 and 23 July 2020.
The referral was discussed in the coordination group on 6 and 23 July 2020 with the participation of the authorisation holder.
(8)
As no agreement was reached in the coordination group, on 21 October 2020, France, as a reference Member State for the purposes of amending the authorisation under Article 48(1), first subparagraph, of Regulation (EU) No 528/2012, referred the unresolved objections to the Commission pursuant to Article 36(1) of that Regulation and provided the Commission with a detailed statement of the matter on which Member States were unable to reach an agreement and the reasons for their disagreement.
That statement was forwarded to the Member States concerned and to the authorisation holder.
(9)
In May 2021, the Finnish Safety and Chemical Agency requested an opinion from the Finnish Food Authority and the Finnish Veterinary Association on the effects of biocidal products containing alphachloralose on pets and the need to restrict the use of such products.
That opinion, which Finland shared with the Commission, stated that biocidal products containing alphachloralose cause significant harm and suffering to both pets and wildlife and that the number of pet poisonings reported to the Finnish Safety and Chemical Agency and the Finnish Food Authority is significant.
(10)
In addition, the Swedish Chemical Agency obtained additional information in the form of blood sample analyses from the University Animal Hospital in Uppsala, Sweden, which confirmed the presence of alphachloralose in the blood of poisoned animals.
(11)
According to Article 19(1), point (b)(iii), of Regulation (EU) No 528/2012, it is a condition for granting an authorisation that the biocidal product has no immediate or delayed unacceptable effects itself, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects.
(12)
Article 19(5), first subparagraph, of Regulation (EU) No 528/2012 provides that a biocidal product may be authorised when the conditions laid down in Article 19(1), point (b)(iii), are not fully met, where not authorising the biocidal product 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.
Furthermore, Article 19(5), second subparagraph, states that the use of a biocidal product authorised pursuant to that provision is to be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment to that biocidal product is minimised.
The use of a biocidal product authorised pursuant to that paragraph is to be restricted to Member States in which the condition set out in Article 19(5), first subparagraph, is met.
(13)
The Commission has carefully examined the information submitted by the Member States and by the authorisation holder of the biocidal product, including the fact that incidents of animal poisoning by products containing alphachloralose were also reported in other Member States and in Norway.
The Commission also takes into account the opinion from the Finnish Food Authority and the Finnish Veterinary Association, as well as the reports from the University Animal Hospital in Uppsala and the Swedish Veterinary Association, which strongly indicate that the biocidal product has unacceptable effects on animal health, and which confirm, by analytical tests conducted on the poisoned animals, that a significant number of incidents of secondary poisoning by alphachloralose involving cats had occurred, as well as all the information provided and the discussions held in the context of disagreements for other biocidal products containing alphachloralose that were referred to the Commission pursuant to Article 36(1) of Regulation (EU) No 528/2012.
(14)
The Commission recognises that it is technically and scientifically impossible to link the reported secondary poisoning cases to a specific biocidal product, as it is not possible to identify which of the specific products was ingested by the mouse that was ingested by the cat.
It is only possible to detect the presence of the active substance alphachloralose in the tissue of the animals and sometimes in the carcases of dead rodents in the stomach of poisoned cats.
However, it is clear that those poisoning incidents were linked to biocidal products containing alphachloralose, including the biocidal product.