EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/11722/2016 ANNEX 
(POOL/E4/2016/11722/11722 -EN 
ANNEX.doc)  
[…](2017) XXX  draft 
ANNEX 1  
  
ANNEX  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
approving dichlofluanid as an existing active substance for use in biocidal products of 
product -type 21    
EN 2   EN ANNEX  
Common Name  IUPAC Name  
Identification Numbers  Minimum degree 
of purity of the 
active substance1 Date of 
approval  Expiry date of 
approval  Prod
uct 
type Specific conditions  
Dichlofluanid  IUPAC Name:   
N-(Dichlorofluoromethylthio) -
N',N' -dimethyl -N-
phenylsulfamide  
 
EC No: 214-118-7 
CAS No: 1085 -98-9 96 % w/w  1 
November  
2018  31 December  
2025 21 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 the event that products containing dichlofluanid  are 
subsequently authorised for use by non -professional users, 
persons making products available on the market for non -
profe ssional users shall ensure that the products are supplied 
with appropriate gloves.  
 
The authorisations of biocidal products are subject to the 
following conditions : 
1) Products containing dichlofluanid  shall not be authorised 
or used to control the growth and  settlement of fouling 
organisms on freshwater going vessels . 
2) For industrial or professional users, safe operational 
procedures and appropriate organisational measures shall 
be established. Where exposure cannot be reduced to an 
acceptable level by other m eans, products shall be used 
with appropriate personal protective equipment.  
3) Labels and, where provided, instructions for use shall 
indicate that children shall be kept away until treated 
surfaces are dry.  
4) Labels and, where provided, safety data sheets of products 
authorised shall indicate that application , maintenance and 
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance evaluat ed in accordance with Article 89(1) of Regulation (EU) No 528/2012 . 
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 3   EN repair activities  shall be conducted within a contained 
area, on  an impermeable hard standing with bunding or on 
soil covered with an impermeable material to prevent 
losses and minimise e missions to the environment, and 
that any losses or waste containing dichlofluanid  shall be 
collected for reuse or disposal.  
5) For products that may lead to residues in food or feed, the 
need to set new or to amend existing maximum residue 
levels (MRLs) in a ccordance with Regulation (EC) No 
470/2009 of the European Parliament and of the Council2 
or Regulation (EC) No 396/2005 of the European 
Parliament and of the Council3 shall be verified, and any 
appropriate risk mitigation measures shall be taken to 
ensure  that the applicable MRLs are not exceeded.  
 
The placing on the market of treated articles is subject to the 
following condition:  
The person responsible for the placing on the market of a 
treated article treated with or incorporating dichlofluanid shall 
ensure that the label of that treated article provides the 
information listed in the second subparagraph of Article 58(3 ) 
of Regulation (EU) No 528/2012.  
 
                                                 
2 Regulat ion (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the est ablishment of residue limits of 
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (E EC) No 2377/90 and amending Directive 2001/82/EC of the European 
Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2 009, p. 11).  
3 Regulation (EC) No 396/2005 of the European Parliam ent and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).