EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10931/2015 
[…](2015) XXX  draft 
  
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 an anti-viral tissue impregnated with citric acid 
(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 an anti-viral tissue impregnated with citric acid 
(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 28 April 2015, Belgium requested th e Commission to de cide, pursuant to 
Article 3(3) of Regulation (EU) No 528/2012, whether an anti-viral tissue placed on 
the market with the claim " kills 99.9% of cold & flu viruses in the tissue"  is a biocidal 
product or a treated article and, if consider ed a biocidal product, whether it would 
belong to product-type 1 (human hygiene) or 2 (disinfectants and algaecides not 
intended for direct applica tion to humans or animals). 
(2) According to the information provided by Be lgium, the tissue is a 3-ply tissue of 
which the middle layer is impregnated with ci tric acid. Citric acid is stated to be 
irreversibly bound into the tissue’s matrix and to remain in the product throughout its 
lifecycle. After the ti ssue has been used, i.e. when moisture after sneezing, coughing 
or blowing of the nose into the tissue hits th e middle layer, citric acid is claimed to 
deactivate the viral load within  the tissue in order to prevent transfer back to the hands, 
transmittance of the virus from hand to hand contact and transmittance to surfaces with which the tissue comes into contact. 
(3) The tissue meets the definition of an arti cle as provided under Article 3(2)(c) of 
Regulation (EU) No 528/2012. 
(4) The tissue meets the definition of a treated article as provi ded under Article 3(1)(l) of 
Regulation (EU) No 528/2012, as c itric acid is intentionally in corporated into it with 
the aim to deactivate viruses and to limit cross-contamination with these viruses. 
(5) Viruses meet the definition of harmful orga nism as provided under Article 3(1)(g) of 
Regulation (EU) No 528/2012 si nce they may have a detrimental effect on humans.   
(6) Destroying, deterring, rendering harmless, preventing the action of, or otherwise 
exerting a controlling effect on any harm ful organism is a biocidal function. 
(7) It is therefore essential to establish whethe r the tissue has a primar y biocidal function 
or not, in order to define whether the tissue is a treated article or  a biocidal product. 
                                                
 
1 OJ L 167, 27.6.2012, p. 1.  
EN 3   EN (8) The claim made on the tissue p ackaging and advertising is “ kills 99.9% of cold & flu 
viruses in the tissue ”. Through such a claim, greater prominence and first importance 
is given to the biocidal function of the tissue than to its other functions (for example to 
blow the nose). The anti-viral tissue has therefore a primary biocidal function.  
(9) Since product-type 1 covers biocidal products used to disinfect the skin or the scalp 
and product-type 2 covers biocidal products  used for wider purposes, such as the 
disinfection of surfaces, materi als or air, the use of the tissue would rather correspond 
to the latter product-type. 
(10) 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 
An anti-viral tissue impregnated with citric acid  and placed on the ma rket with the claim " kills 
99.9% of cold & flu viruses in the tissue" shall be considered as a biocidal product in 
accordance with Article 3(1)(a) of Regulatio n (EU) No 528/2012 and shall fall within 
product-type 2 as defined in Annex V to that Regulation. 
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 . 
Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER