COMMISSION IMPLEMENTING DECISION (EU) 2020/433
of 12 March 2020
concerning the extension of the action taken by the Swedish Chemicals Agency permitting the making available on the market and use of the biocidal product Care Plus Mosquito Net in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
(notified under document C(2020) 1342)
(Only the Swedish text is authentic)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to 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 (1), and in particular the third subparagraph of Article 55(1) thereof,
Whereas:
(1) On 25 September 2019 the Swedish Chemicals Agency (the ‘competent Swedish authority’) adopted a decision in accordance with the first subparagraph of Article 55(1) of Regulation (EU) No 528/2012 to permit until 23 March 2020 the making available on the market and use of the biocidal product Care Plus Mosquito Net, a mosquito net impregnated with the active substance permethrin (‘the action’). The competent Swedish authority informed the Commission and the competent authorities of the other Member States about the action and the justification for it, in accordance with the second subparagraph of Article 55(1) of that Regulation.
(2) According to the information provided by the competent Swedish authority, the action was necessary in order to protect public health. The use of the mosquito net impregnated with permethrin is intended to provide protection of humans against stinging and biting insects, thus preventing the transmission to them of pathogens by insect vectors, which pose a risk to public health. Under the conditions specified in the action, the product can be made available only in vaccination clinics and only together with instructions for proper use and safe disposal and, after the derogation period, the addressee of the action must, if requested by the competent Swedish authority, provide information on the number of nets distributed to the vaccination clinics.
(3) On 26 November 2019, the Commission received a reasoned request from the competent Swedish authority to extend the action in accordance with the third subparagraph of Article 55(1) of Regulation (EU) No 528/2012. The request was made on the basis of the continued concern that public health might be endangered by vector-borne diseases beyond 23 March 2020 and of the argument that the biocidal product Care Plus Mosquito Net is crucial in order to contain the danger posed by vector-borne diseases.
(4) According to the information provided by the competent Swedish authority, the alternatives for insect vector control (e.g. use of repellents, non-impregnated mosquito nets) do not allow a sufficient control of the vector insects.
(5) Repellents cannot provide a 24-hour protection of the whole human body due to the restriction of the number of daily applications and the fact that they should not be used on certain body parts. People with sensitive or damaged skin may experience problems using repellents due to irritation. In addition, the repellents have limited use for specific age groups, such as young children. Non-treated mosquito nets do not offer full protection against insects, as such nets do not ensure that insects present on the net cannot attack body parts that can be reached through the net. Untreated nets might also encourage people to impregnate the nets with biocidal products themselves. Such uncontrolled and undocumented use might pose a risk for human health and the environment.
(6) An application for Union authorisation of the biocidal product Care Plus Mosquito Net has been submitted to the European Chemicals Agency, with the Danish authority as evaluating competent authority, and is still under evaluation. A Union authorisation of this biocidal product would represent a permanent solution for the future including for Sweden, but a significant amount of time is still needed to evaluate the application before the authorisation can be granted.
(7) It is therefore appropriate to allow the competent Swedish authority to extend the action for a period not exceeding 550 days and under certain conditions.
(8) 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 Swedish Chemicals Agency may extend until 25 September 2021 the action to permit the making available on the market and use of the biocidal product Care Plus Mosquito Net to prevent the transmission of pathogens by insect vectors to humans, provided that the Agency ensures that the product is only made available and used under its supervision.
Article 2
This Decision is addressed to the Kingdom of Sweden.
Done at Brussels, 12 March 2020.
For the Commission
Stella KYRIAKIDES
Member of the Commission
(1)
OJ L 167, 27.6.2012, p. 1
.
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