EN   EN  
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10857/2018 
(POOL/E4/2018/10857/10857 -EN.doc)  
[…](2018) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving cholecalciferol as an active substance for use in biocidal products of product -
type 14 
(Text with EEA relevance)   
EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
approving cholecalciferol as an active substance for use in biocidal products of product -
type 14 
(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 th e making available on the market and use of biocidal 
products1, and in particular Article  9(1)(a)  thereof,  
Whereas:  
(1) The evaluating competent authority of Sweden  received on 19 April 2013  an 
application , in accordance with Article 11(1) of Directive 98/8/EC  of the European 
Parliament and of the Council2, for the inclusion  of the active substance 
cholecalciferol  in Annex I to that Directive  for use in biocidal products of product -type 
14, rodenticides, as described in Annex V  to Directive 98/8/EC , which corre sponds to 
product -type 14 as described in Annex V  to Regulation (EU) No  528/2012.  
(2) On 15 April 2016 , the evaluating competent authority of Sweden  submitted , in 
accordance  with Article 8(1) of Regulation (EU) No  528/2012 , the assessment report 
together with its recommendations  to the European Chemicals Agency  (‘the Agency’) . 
(3) The opinion of the Agency3 was adopted  on 13 December 2017 by the Biocidal 
Products Committee, having regard to the conclusions of the evaluating competent 
authority.  
(4) According to that op inion, cholecalciferol  is a pro -hormone and therefore meets the 
criteria laid down in Commission Delegated Regulation (EU) 2017/21004 to be 
considered as having endocrine -disrupti ng properties  that may cause adverse effects in 
humans . Cholecalciferol  therefore meets the exclusion criterion set in Article 5(1)( d) 
of Regulation (EU) No  528/2012 . 
(5) In addition , according to that opinion, the use of products containing  cholecalciferol  
raises concerns of primary and secondary poisoning, even whe n restrictive  risk 
management measures  are applied and therefore  cholecalciferol  also satisfies the 
                                                 
1 OJ L  167, 27.6.2012, p.  1. 
2 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the 
placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).  
3 Biocidal Products Committee Opinion on the application for approval of the active substance:  
Cholecalciferol, Product type: 14, ECHA/BPC/180/2017 . 
4 Commission Delegated Regulation (E U) 2017/2100  of 4 September 2017 setting out scientific criteria 
for the determination of endocrine -disrupting properties pursuant to Regulation (EU ) No 528/2012 of 
the European Parliament and Council  (OJ L 301, 17.11.2017 , p. 1).  
EN 2  EN criterion to be considered a candidate for substitution in accordance with Article 
10(1)(e) of Regulation  (EU) No  528/2012  
(6) Pursuant to Article 5(2) of Regulation  (EU) No  528/2012 , an active substance meeting  
an exclusion criteri on may only be approved if it is shown that at least one of the 
conditions for derogation set out in that Article  is met . 
(7) In accordance with Article 10(3) of Regulation  (EU) No 528/2012 , the Agency  
organised a  public consultation between 17 July 2017 and 15 September 2017 in order 
to collect relevant information, including information on available substitutes5.  
(8) The Commission also carried out  a specific pu blic consultation between 7 February 
2018 a nd 7 April 2018  in order to gather information as to whether the conditions for 
derogation set out in Article 5(2) of Regulation (EU) No 528/2012 were  satisfied . The 
Commission made the contributions received during  that consultation publicly 
available6. 
(9) The information obtained as a result of  the two above -mentioned public consultations, 
the experience gained in authoris ing rodenticide products and the renewal of approval 
of anticoagulant active substances used in rodenticides , and the information on the 
availability of alternatives to anticoagulant rodenticides included in Annex 1 to the 
Commission final report  on risk mitigation measures for anticoagulant rodenticides  as 
biocidal products7, were  discussed with Member States in the Standing Committee o n 
Biocidal Products.  
(10) Rodents can carry pathogens that are responsible for many zoonoses, which can pose 
serious dangers for human or animal health. Anticoagulant active substances, which 
are the main active substances used in rodenticides for now, also meet the exclusion 
criteria laid down in Article 5(1) of Regulation (EU) No  528/2012  as they are 
classified as toxic for reproduction category 1B and most of them are persistent, bio -
accumulative and toxic (PBT) or very persistent and very bio -accumulative (vPvB ) 
substances. Other alternative active substances currently approved for product -type 14 
and not subject to exclusion , namely  carbon dioxide, alphachloralose, alumin ium 
phosphide, hydrogen cyanide and  powdered corn cob , have constraints inherent in 
their nature and restricted conditions of use. Non-chemical control or prevention 
methods for rodent s, such as mechanical, electrical or glue traps, may not be 
sufficiently efficient and may raise further questions as to whether they are humane 
and whether they  cause unnecessary suffering to rodents.  
(11) The approval of cholecalciferol would bring an additional active substance on the 
market and would be useful to manage the increasing development of resistance of 
rodents to anticoagulant active substances , as c holecalciferol acts in a completely 
different way compared to the anticoagulants. The availability of cholecalciferol may 
also reduce the use of anticoagulant active substances and in particular of the most 
potent second -generation  thereof . Thus, cholecalcifer ol can play a role in the future to 
ensure satisfactory control of rodent populations within an integrated pest management 
approach, in support of the above -mentioned alternatives not subject to the exclusion 
criteria, and possibly reducing the recourse to  anticoagulant active substances in 
rodenticides.  
                                                 
5 https://echa.europa.eu/potential -candidates -for-substitution -previous -consultations  
6 https://circabc.europa.eu/w/browse/c29a57c2 -e31d -43d8 -9675 -6aec345218cf   
7 https://circabc.europa.eu/sd/a/352bffd8 -babc -4af8-9d0c -a1c87a3c3afc/Final%20Report%20RMM.pdf    
EN 3  EN (12) Furthermore, i nsufficient rodent control may cause not only significant negative 
impacts on human or animal health or the environment, but also affect the public's 
perception of its safety with regard to exposure to rodents  or the security of a number 
of economic activities that could be vulnerable to rodents, entailing  economic and 
social consequences. Despite its endocrine disrupting properties, cholecalciferol may 
be considered to have overall better to xicological and ecotoxicological profiles 
compared to anticoagulant active substances as it is neither classified as toxic for 
reproduction category 1B, nor a PBT  or vPvB. Cholecalciferol is Vitamin D3, which – 
at the right dose - is an essential element f or human life, and is expected to present 
lower risks to humans compared to anticoagulant active substances  when used a s a 
rodenticide . The risks to human health, animal health or the environment arising from 
use of products containing cholecalciferol  can be mitigated if certain specifications 
and conditions  are respected . As already explained, c holecalciferol c an play a role in 
the future to contribute to a satisfactory control of rodent populations within an 
integrated pest management approach, in support  of the above -mentioned alternatives 
not subject to the exclusion criteria, and possibly reducing the recourse to 
anticoagulant rodenticides which present higher overall concerns. In this context, not 
approving th at active substance would deprive users of a tool f or rodent control  which 
could bring added value and which is at least as suitable as many other alternative  
substances used . Therefore, the non -approval of cholecalciferol as an active substance 
would have a disproportionate negative impact on soci ety in comparison to the risks 
arising from the use of the substance. The condition set out in Article 5(2)(c) is thus 
satisfied.   
(13) It is therefore appropriate to appro ve cholecalciferol  for use in biocidal products of 
product -type 14, subject to compliance with certain specifications and conditions . 
(14) As cholecalciferol  meets exclusion criterion laid down in Article 5(1)(d) of Regulation 
(EU) No 528/2012 , the approval should be for a period not exceeding five years  as set 
out in  the secon d sentence of  Article 4 (1) of that Regulation . 
(15) The measures provided for in this Regulation are in accordance with the opinion of the 
Standing  Committee on Biocidal Products , 
HAS ADOPTED THIS REGULATION:  
Article  1 
Cholecalciferol is approved  as an active s ubstance for use in biocidal products of product -
type 14, subject to the specifications and conditions  set out in the Annex.  
Article  2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union .  
EN 4  EN This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude JUNCKER