1 
 EN 
 
ANNEX 
Common Name IUPAC Name 
Identification Numbers Minimum degree 
of purity of the 
active substance1 Expiry date of 
approval Pro-
duct 
type Specific conditions 
Difethialone IUPAC Name:  
3-[3-(4’-bromo[1,1’biphenyl]-4-yl)-1,2,3,4-tetrahydronaphth-1-yl]-4-
hydroxy-2H-1-
benzothiopyran-2-one 
 EC No: Not available CAS No: 104653-34-1 976 g/kg 
 
The specification of 
purity is based on 
the combined 
concentration of 
both 
diastereoisomers 
(cis and trans). 30 June 2024 14 Difethialone 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 th e 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 assessment 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 author ised for use in Member 
States where at least one of the conditions set out in 
Article 5(2) of Regulation (EU)  No 528/2012 is  satisfied. 
3) The nominal concentration of difethialone in the products 
shall not exceed 25 mg/kg. 
4) Products shall contain an aversive agent and a dye. 
5) Products shall not be authoris ed in the form  of tracking 
powder. 
6) Products in the form of contact formulations, other than 
                                                            
1 The purity indicated in this column was the minimum degree of purity of the active substance ev aluated. The active substance i n 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. 2 
 tracking powder, shall only be authorised for use by 
trained professionals indoors in places not accessible to children or non-target animals. 
7) Only ready-to-use products shall be authorised. 
8) Primary as well as secondar y exposure of humans, non-
target animals and the environment are minimised, by 
considering and applying all ap propriate and available risk 
mitigation measures. These include for example the 
restriction to professional or trained professional use when 
possible and setting additional specific conditions per user category. 
9) Dead bodies and uneaten bait shall be disposed of in 
accordance with local requ irements. 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 addition to the general conditions, the authorisations of 
biocidal products to be used by the general public are subject 
to the following conditions: 
1) Products shall only be author ised for use in tamper-
resistant bait stations. 
2) Products shall only be supplied with a maximum quantity 
of bait per pack of: 
a) For products against mice only: 
i) For grain, pellet or paste baits: 50 g. 
ii) For wax block baits: 100g. 
b) For products against rats only, or mice and rats:  
i) For grain, pellet or paste baits: 150 g. 
ii) For wax block baits: 300g. 
3) Products against Rattus norvegicus  and Rattus rattus  shall 
only be authorised for use indoors or in and around 
buildings. 
4) Products against Mus musculus  shall only be authorised 
for use indoors. 
5) Products shall not be authoris ed for use in permanent or 3 
 pulse baiting treatments. 
6) Persons making products available on the market shall 
ensure that the products ar e accompanied by information 
on the risks associated with anticoagulant rodenticides in 
general, measures to limit their use to the minimum 
necessary and appropriate precau tionary steps to be taken. 
7) Products in the form of loose bait formulations, such as 
grain or pellets, shall only be authorised in formulations 
that are supplied in sachets or other packaging to reduce 
exposure to humans and the environment. 
 
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 sewage, open 
area or waste dumps. 
2) Products shall not be authoris ed for use in permanent or 
pulse baiting treatments. 
3) Products shall only be author ised for use in tamper-
resistant bait stations. 
4) Persons making products for professional users available 
on the market shall make sure that these products are not 
supplied to the general public. 
 
In addition 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 sewage, open area 
or waste dumps. 
2) Products may be authorised for use 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 be authorised for use in pulse baiting 
treatments. 
4) Products shall not be author ised for use in permanent 4 
 baiting treatments. 
5) Persons making products for trained professional users 
available on the market shall make sure that the products 
are not supplied to other persons than trained 
professionals.