Commission Implementing Decision (EU) 2017/721 of 20 April 2017 concerning the extension of the action taken by Sweden on the making available on the market and use of the biocidal product VectoBac 12AS in accordance with Article 55(1) of Regulation (EU) No 528/2012 of the European Parliament and of the Council (notified under document C(2017) 2435)
Date: 2017-04-20
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: Sweden, chemical product, insecticide, market approval, marketing standard








L_2017106EN.01001201.xml










22.4.2017   


EN


Official Journal of the European Union


L 106/12








            COMMISSION IMPLEMENTING DECISION (EU) 2017/721
of 20 April 2017
         
concerning the extension of the action taken by Sweden on the making available on the market and use of the biocidal product VectoBac 12AS in accordance with Article 55(1) of Regulation (EU) No 528/2012 of the European Parliament and of the Council


(notified under document C(2017) 2435)


(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 third subparagraph of Article 55(1) thereof,

Whereas:







(1)


On 6 September 2016, Sweden adopted a decision in accordance with the first subparagraph of Article 55(1) of Regulation (EU) No 528/2012, to permit until 5 March 2017 the making available on the market and use of the biocidal product VectoBac 12AS for the control of the outbreak of midges, Chironomidae, in several sewage treatment plants in Sweden (‘the action’).












(2)


On 28 October 2016, the Commission received a reasoned request from Sweden in accordance with the third subparagraph of Article 55(1) of Regulation (EU) No 528/2012 to extend the action. The reasoned request was based on the argument that VectoBac 12AS is essential for the control of midges in the very particular context of sewage treatment plants in Sweden.












(3)


VectoBac 12AS contains Bacillus thuringiensis subsp. israelensis serotype H14, strain AM65-52 as an active substance for use in product-type 18 as described in Annex V to Regulation (EU) No 528/2012. According to the information provided by Sweden, the extension of the action is necessary in order to protect the workers at sewage treatment plants. This information illustrated long-lasting occupational exposure to large amounts of adult midges and potential sensitisation can cause the development of asthma and allergic reactions, which can induce anaphylaxis in more severe cases.












(4)


Sweden stated that in the past several permissions for use of VectoBac 12AS in research trials had been granted. The outcome of these trials revealed that alternative methods, including physical methods, did not provide appropriate solutions to control the midges in an effective way. Moreover, due to the specific needs of sewage treatment plants, other biocidal products showed to be inadequate in terms of application and efficiency.












(5)


As the lack of appropriate control of the midges, which cannot be contained by other means, might lead to a danger to public health, it is appropriate to allow Sweden to extend the action under certain conditions.












(6)


The measure provided for in this Decision is in accordance with the opinion of the Standing Committee on Biocidal Products,





HAS ADOPTED THIS DECISION:



Article 1
Sweden may extend for a period not exceeding 550 days the action to make available on the market and use the biocidal product VectoBac 12AS for midges control in sewage treatment plants and under the supervision of the competent authority.


Article 2
This Decision is addressed to the Kingdom of Sweden.




Done at Brussels, 20 April 2017.


For the Commission

Vytenis ANDRIUKAITIS
            

Member of the Commission






(1)  
            OJ L 167, 27.6.2012, p. 1.