CELEX: 
Language: en
Date: 2018-04-11
Title: COMMISSION IMPLEMENTING DECISION (EU) …/… pursuant to Article 3(3) of Regulation (EU) No 528/2012 of the European Parliament and of the Council on a product containing permethrin used as a topical insecticide on livestock

COMMISSION IMPLEMENTING DECISION (EU) …/…
            
            
               of XXX
            
            
               pursuant to Article 3(3) of Regulation (EU) No 528/2012 of the European Parliament and of the Council on a product containing permethrin used as a topical insecticide on livestock
            
            
               (Text with EEA relevance)
            
            
               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
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               , and in particular Article 3(3) thereof,
            
            
               Whereas:
            
            
               (1)On 9 March 2017, the Netherlands requested the Commission to decide whether a topical insecticide which contains permethrin ("the product") and is placed on the market to control certain insects on the skin of livestock (cattle, sheep, horses and donkeys) is a biocidal product within the scope of Regulation (EU) No 528/2012.
            
            
               (2)According to the information provided by the Netherlands, the product was subject to an application for a mutual recognition in parallel in accordance with Article 34 of Regulation (EU) No 528/2012 as an insecticide under product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Regulation. The target organisms specified in the application are adult stable flies (Stomoxys spp.) and midges (Culicoides spp.), which will be killed when landing on the animal. The product consists of a solution for external use only, being directly applied on the back of the animal from head to tail.
            
            
               (3)The product is currently made available and used as a biocidal product in Belgium and the Netherlands in accordance with the system or practice referred to in the first subparagraph of Article 89(2) of Regulation (EU) No 528/2012. France has suspended the making available and use in France of the product as a biocidal product as it considers that the product is a veterinary medicinal product falling under the scope of Directive 2001/82/EC of the European Parliament and of the Council
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               . The Czech Republic also considers that the product falls under the scope of that Directive. 
            
            
               (4)The product is a mixture within the meaning of Article 3(2) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council
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               . Therefore, pursuant to Article 3(2)(b) of Regulation (EU) No 528/2012, it is considered a mixture also for the purposes of that Regulation.
            
            
               (5)The product contains permethrin, which is an active substance within the meaning of Article 3(1)(c) of Regulation (EU) No 528/2012.
            
            
               (6)The product is intended to destroy harmful organisms within the meaning of Article 3(1)(g) of Regulation (EU) No 528/2012 since the insects it targets have an unwanted presence or a detrimental effect on animals.
            
            
               (7)Therefore, the product as supplied to the user fulfils the definition of a biocidal product within the meaning of the first indent of Article 3(1)(a) of Regulation (EU) No 528/2012. 
            
            
               (8)However, in accordance with Article 2(1) of Regulation (EU) No 528/2012, a list of the types of biocidal products covered by that Regulation is set out in Annex V to that Regulation. From the provisions in Articles 4(2) and 22(2)(j) of that Regulation, it can be deduced that the allocation to an appropriate product-type is an intrinsic and essential part in the approval of active substances and the authorisation of biocidal products. Therefore, the definition of a biocidal product laid down in the first indent of Article 3(1)(a) of Regulation (EU) No 528/2012 should be considered in combination with the description of the product-types specified in Annex V of that Regulation. 
            
            
               (9)Annex V to Regulation (EU) No 528/2012 organises biocidal product-types in four Main Groups. Biocidal products used to exert any controlling effect on insects are in Main Group 3 (Pest control) and should correspond to the description of product-types 18 (Insecticides, acaricides and products to control other arthropods) or 19 (Repellents and attractants). 
            
            
               (10)The description of product-type 19 in Annex V to Regulation (EU) No 528/2012 explicitly specifies that it includes products for human or veterinary hygiene that are directly used on the skin of humans or animals. A similar provision is also included in the description of product-types 1 and 3 in Annex V, specifying explicitly that certain disinfectants can be directly used on the skin of humans or animals, respectively. 
            
            
               (11)Taking into account that permethrin is not under assessment nor approved
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                for use in biocidal products of product-type 19, that it cannot be claimed that the product has any attractant or repellent effect on target organisms and that the description of product-type 18 does not state that biocidal products falling under that product-type can be directly used on the skin of humans or animals, it is therefore concluded that the product is not a biocidal product falling within product-type 18 as specified in Annex V to Regulation (EU) No 528/2012. 
            
         
         
            
               (12)The Commission notes that this conclusion is consistent with Commission Implementing Decision (EU) 2016/903
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               , which considered that a horse rug impregnated with permethrin that is not designed to be applied as a topical insecticide is to be considered as a biocidal product falling within product-type 18 as specified in Annex V to Regulation (EU) No 528/2012. 
            
            
               (13)Moreover, pursuant to Article 2(2) of Regulation (EU) No 528/2012, that Regulation does not apply to biocidal products that are within the scope of any of the instruments referred to in that paragraph, including Directive 2001/82/EC, subject to any explicit provision to the contrary in that Regulation or other Union legislation. 
            
            
               (14)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
            
            
               A permethrin containing insecticide directly used on the skin for the purpose of controlling insects on livestock shall not be considered a biocidal product within the scope of Regulation (EU) No 528/2012.
            
            
               Article 2
            
            
               This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            
            
               Done at Brussels,
            
            
               
                     For the Commission
               
               
                     The President
               
               
                     Jean-Claude JUNCKER