EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10870/2017 
(POOL/E4/2017/10870/10870-EN.doc) 
[…](2017) XXX  draft 
  
COMMISSION IMPLEMENTING DECISION 
of XXX  
pursuant to Article 3(3) of Regulation (EU) No 528/2012 of the European Parliament 
and of the Council on a permethrin containing topical insecticide used for the purpose of 
controlling insects on livestock  
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING DECISION 
of XXX  
pursuant to Article 3(3) of Regulation (E U) No 528/2012 of the European Parliament 
and of the Council on a permethrin containing topical insecticide used for the purpose of 
controlling insect s 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 avai lable on the market and use of biocidal 
products
1, and in particular Article 3(3) thereof, 
Whereas: (1) On 9 March 2017, the Netherlands requested  the Commission to decide, pursuant to 
Article 3(3) of Regulation (EU) No 528/2012, whether a permethrin containing 
product ("the product") placed on the market to be used to control a number of insects 
on the skin of livestock ( cattle, sheep, horses and donkeys) is a biocidal product or a 
treated article or neither. 
(2) According to the information provided by th e Netherlands, the product is intended to 
be authorised as an ins ecticide under product-type 18, as defined in Annex V to 
Regulation (EU) No 528/2012. The product cons ists of a solution for external use 
only, being directly applied on the back of the animal from  head till tail. The target 
organisms in the application are adult stable flies ( Stomoxys  spp.) and midges 
(Culicoides  spp.), which will be killed when landing on the animal.  
(3) The product is currently placed on the market of Belgium and the Netherlands 
according to the systems referred to in Article  89(2) of that Regulation as a biocidal 
product.  
(4) The product meets the definition of a mixtur e referred to in Article 3(2)(b) of 
Regulation (EU) No 528/2012. 
(5) The product contains permethrin, which meets the definition of an active substance as 
provided under Article 3(1 )(c) of that Regulation. 
(6) The target organisms in the application meet  the definition of harmful organism as 
provided under Article 3(1)(g) of Regulati on (EU) No 528/2012 since they may have a 
detrimental effect on animals or humans.  
(7) In accordance with Article 3(1)(a) of that  Regulation, destroying, deterring, rendering 
harmless, preventing the action of, or othe rwise exerting a controlling effect on any 
harmful organism is a biocidal function. 
                                                 
1 OJ L 167, 27.6.2012, p. 1.  
EN 3   EN (8) Therefore, the product as it is  supplied to the user meets the definition of a biocidal 
product provided under the first indent of Article 3(1)(a) of Regulation (EU) No 
528/2012. 
(9) In accordance with Article 2(2) of Regulati on (EU) No 528/2012 it is also important to 
consider whether the product may fall within  the scope of Direc tive 2001/82/EC of the 
European Parliament and of the Council2 if it meets the definition of a veterinary 
medicinal product as provided under Ar ticle 1(2) of that Directive. 
(10) Since i) the product is applied as a topica l insecticide in orde r to kill the target 
organisms present on the animal; ii) the target organisms infesting the animal are ecto-parasites and may cause an animal disease;  iii) the application of the product may 
either eliminate or limit the development of  infestations, the product could be seen by 
the user as having properties for trea ting or preventing the above mentioned 
infestations. As a consequence, the produc t could be consider ed as meeting the 
definition of a veterinary medicinal produ ct as provided under Article 1(2) of 
Directive 2001/82/EC. 
(11) A withdrawal period, as provide d for under Article 1(9) of that Directive, sets the 
period necessary between the last administra tion of a veterinary medicinal product to 
animals and the production of foodstuffs from su ch animals. It is one of the essential 
requirements towards the use of veterina ry medicinal products in food-producing 
animals in order to ensure food safety. The Commission notes that the product, as currently placed on the market  of Belgium and the Netherla nds, is presented as having 
a withdrawal period for meat. 
(12) Pursuant to Article 2(2) of  Directive 2001/82/EC, in cases of doubt, where, taking into 
account all its characteristics, a product may fall within the defin ition of a veterinary 
medicinal product and within the definiti on of a product covered by other Community 
legislation, the provisions of that Directive shall apply. 
(13) Therefore, in accordance with Article 2(2)(c) of Regulation (EU) No 528/2012, the 
product does not fall under the scope of that Regulation. 
(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 topical insecticide used for the purpose of controlling insects on 
livestock shall not be consider ed as a biocidal product falli ng under the scope of Regulation 
(EU) No 528/2012. 
Article 2 
This Decision shall enter into force on the twen tieth day following that of its publication in 
the Official Journal of  the European Union . 
                                                 
2 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the 
Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).  
EN 4   EN Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER