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 conditions2 
Tolylfluanid IUPAC Name :  
N-(Dichlorofluoromethylthio)-N',N'-
dimethyl-N-p-tolylsulfamide 
EC n° : 211-986-9 CAS n° : 731-27-1 960 g/kg 1 July 
2016 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 tolylfluanid are 
subsequently authorised fo r use by non-professional 
users, persons making products containing tolylfluanid available on the market for non-professional users shall ensure that the products are supplied with appropriate gloves. 
For biocidal products, author isations are subject to the 
following conditions: 
(1) Products containing toly lfluanid shall not be 
                                                            
1 The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in a ccordance with Article 8 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  technically equivalent with the evaluated 
active substance. 
2 For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of ass essment reports are available on the 
Commission website: http://ec.europa.eu/environment/chemicals/biocides/index_en.htm .  
 
2 
 Common 
Name IUPAC Name 
Identification Numbers Minimum degree of 
purity of the active 
substance1  Date of 
approval Expiry date 
of approval Product 
type Specific conditions2 
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 means, 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 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 emissions to the environment, and that any losses or waste 
containing tolylfluanid shall be collected for 
reuse or disposal. 
                                                                                                                                                                                                                                                                                                          
3  Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of 
pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) 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, 16.6.200 9, p. 11). 
4  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pe sticides 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).  
 
3 
 Common 
Name IUPAC Name 
Identification Numbers Minimum degree of 
purity of the active 
substance1  Date of 
approval Expiry date 
of approval Product 
type Specific conditions2 
(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 accordance 
with Regulation (EC) No 470/2009 of the 
European Parliament and of the Council3  o r  
Regulation (EC) No 396/2005 of the European 
Parliament and of the Council4  shall be verified, 
and any appropriate risk mitigation measures 
shall be taken to ensure that the applicable MRLs are not exceeded. 
 
For treated articles, the following condition applies :  
Where a treated article has been treated with or 
intentionally incorporates one or more biocidal products 
containing tolylfluanid, and where necessary due to the 
possibility of skin contact as well as the release of 
tolylfluanid under normal cond itions of use of the treated 
article, the person responsible for placing the treated 
article on the market shall en sure that the label provides 
information on the risk of skin sensitisation, as well as the 
information referred to in the second subparagraph of 
Article 58(3) of Regulation (EU) No 528/2012.