EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
CA-July13-Doc.4.6 
[…](2013) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
to approve tralopyril as a new active substan ce for use in biocidal products for product-
type 21 
(Text with EEA relevance) 
 EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
to approve tralopyril as a new active substanc e for use in biocidal products for product-
type 21 
(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 the making av ailable on the market and use of biocidal 
products1, and in particular th e third subparagraph of Article 9(1) thereof,[ please check the 
legal basis, it doesn't seem correct]  
Whereas: 
(1) The United Kingdom received on 28 August 2009 an application in accordance with 
Article 11(1) of Directive 98/8/EC of th e European Parliament and of the Council2, for 
the inclusion of the active s ubstance tralopyril in its Anne x I for use in product-type 
21, antifouling products, as de fined in Annex V to that Directive, which corresponds 
to product-type 21 as defined in Annex V to Regulation (EU) No 528/2012. Tralopyril 
was not on the market on the date referred to in Article 34(1) of Directive 98/8/EC as 
an active substance of a biocidal product.  
(2) Tralopyril has been evaluated in accordance with Article 11(2) of Directive 98/8/EC 
for use in product-type 21. 
(3) The competent authority report was re viewed by the Member States and the 
Commission. The findings of the review we re incorporated, within the Standing 
Committee on Biocidal Produc ts on 27 September 2013, in an assessment report. 
(4) It appears from that report? that biocid al products used for product-type 21 and 
containing tralopyril may be expected to satis fy the requirements la id down in Article 
5 of Directive 98/8/EC. It also appears from that report that such biocidal products 
may be expected to satisfy the requirements laid down in Article 19 of Regulation (EU) No 528/2012, provided that the conditions set out in the Annex to this Regulation are satisfied. 
(5) It is therefore appropriate to approve tral oyril for use in biocidal products for product-
type 21. 
(6) A reasonable period should be allowed to elapse before an active substance is 
approved, in order to permit Member States, interested parties, and the Commission 
where appropriate, to prepare themselves to meet the new requirements entailed.  
                                                
 
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). EN 3   EN (7) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products,  
HAS ADOPTED THIS REGULATION: 
Article 1 
Tralopyril shall be approved as an active substa nce for use in biocidal products for product-
type 21, subject to the sp ecifications and condition s 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 . 
This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels,  
 For the Commission 
 The President  José Manuel BARROSO   
EN 4   EN ANNEX  
Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
3 Date of 
approval Expiry date 
of approval Product 
type Specific conditions4 
Tralopyril 
 IUPAC Name :  
4-bromo-2-(4-chlorophenyl)-5-
(trifluoromethyl)-1H-pyrrole-3-carbonitrile  
EC n° : N/A  
CAS n° : 122454-29-9 
 900 g/kg 1 
September 
2015  31 August 
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. 
Authorisations are subject to the following 
conditions: 
1) [please use double brackets in 
English] For industrial or 
professional users, safe 
operational procedures and 
appropriate organizational measures shall be established. 
Only where exposure cannot be 
reduced to an acceptable level by other means, products shall be 
used with appropriate personal 
protective equipment. 
2) [please use double brackets in 
English]In view of the risk for 
marine surface waters, labels and, 
                                                 
3 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. 
4 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/comm/environment/biocides/index.htm .  
EN 5   EN Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
3 Date of 
approval Expiry date 
of approval Product 
type Specific conditions4 
where provided, safety data sheets 
of products authorised for professional use on vessels >25m 
shall indicate that emissions to 
marine surface waters from application, maintenance and 
repair activities have to be 
minimized and that any losses 
shall be collected for reuse or 
disposal. 
3) [please use double brackets in 
English]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 Council
5 or Regulation (EC) 
No 396/2005 of the European 
Parliament and of the Council6 
shall be verified, and any appropriate risk mitigation 
measures shall be taken to ensure 
that the applicable MRLs are not 
                                                                                                                                                                                                                                                    
5 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for t he 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). 
6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pes ticides 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).  
EN 6   EN Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
3 Date of 
approval Expiry date 
of approval Product 
type Specific conditions4 
exceeded.