EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10857/2018 ANNEX 
(POOL/E4/2018/10857/10857 -EN 
ANNEX.doc)  
[…](2018) XXX  draft  
ANNEX  
 
ANNEX  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
approving cholecalciferol as an active substance for use in biocidal products of product -
type 14  
   
EN 1  EN ANNEX  
Common Name  IUPAC Name  
Identification Numbers  Minimum degree of 
purity of the active 
substance1 Date of 
approval  Expiry 
date of 
approval  Product 
type Specific conditions  
Cholecalciferol  IUPAC Name:   
(3β,5Z,7E) -9,10-secocholesta -
5,7,10(19) -trien-3-ol 
 
EC No: 200-673-2 
CAS No: 67-97-0 970 g/kg  1 July 2019  30 June 
2024  14 Cholecalciferol  is considered a candidate for substitution in 
accordance with points (a) and (e) of Article 10(1) of Regulation 
(EU) No 528/2012.  
 
The authorisations of biocidal products are subject to the 
following general conditions:  
(1) The product assessment shall pay particular attention to 
the exposures, the risks and the efficacy linked to any 
uses covered by an application for authorisation, but not 
addressed in the Union level risk assessment of the 
active substance. In addition, pursuant to point 10 of 
Annex VI to Regulation (EU) No 528/2012, the product 
assessm ent shall include an evaluation as to whether the 
conditions of Article 5(2) of Regulation (EU) No 
528/2012 can be satisfied.  
(2) Products shall only be authorised for use in Member 
States where at least one of the conditions set out in 
Article 5(2) of Regulat ion (EU) No 528/2012 is 
satisfied.  
(3) According to point (d) of Article 19(4) of Regulation 
(EU) No 528/2012, products shall not be authorised for 
making available on the market for use by the general 
public.  
(4) The nominal concentration of cholecalciferol in th e 
products shall not exceed 0,075 % w/w.  
(5) Products shall contain an aversive agent and a dye.  
(6) Products shall not be authorised in the form of tracking 
                                                 
1 The purity indicated in this column was the minimum degree of purity of the  active substance evaluated . The active substance in the product placed on the market can be of 
equal or different purity if it has been proven to be technically equivalent to the evaluated active substance .  
EN 2  EN powder.  
(7) Products in the form of contact formulations, other than 
tracking powder, shall only be authorised  for use by 
trained professionals indoors in places not accessible to 
children or non -target animals.  
(8) Only ready -to-use products shall be authorised.  
(9) Primary as well as secondary exposure of humans, non -
target animals and the environment shall be minimised , 
by considering and applying all appropriate and 
available risk mitigation measures. They include for 
example the restriction to professional or trained 
professional use when possible and setting additional 
specific conditions per user category.  
(10) Dead bodi es and uneaten bait shall be disposed of in 
accordance with local requirements. The method of 
disposal shall be described specifically in the summary 
of the product characteristics of the national 
authorisation and be reflected on the product label.  
 
In ad dition to the general conditions, the authorisations of biocidal 
products to be used by trained professionals are subject to the 
following conditions:  
(1) Products may be authorised for use in sewers, open area 
or waste dumps.  
(2) Products may be authorised for us e in covered and 
protected bait points as long as they provide the same 
level of protection for non -target species and humans as 
tamper -resistant bait stations.  
(3) Products may only be authorised for use in permanent 
treatments at sites with a high potential for reinvasion 
when other methods of control have proven 
insufficient.  
(4) Products shall not be authorised for use in pulse baiting 
treatments.  
(5) Persons making products for trained professional users 
available on the market products for trained  
EN 3  EN professional users shall make sure that those products 
are not supplied to other persons  than trained 
professionals.  
 
In addition to the general conditions, the authorisations of biocidal 
products to be used by professionals are subject to the following 
conditions:  
(1) Products shall not be authorised for use in sewers, open 
area or waste dumps.  
(2) Products shall not be authorised for use as a permanent 
bait or pulse baiting treatments.  
(3) Products shall only be authorised for use in tamper -
resistant bait stations.  
(4) Persons makin g available on the market products for 
professional users shall make sure that those products 
are not supplied to the general public.