EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
CA-Sept13-Doc.3.2 
[…](2013) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving S-methoprene as an ex isting active substance for us e in biocidal products for 
product-type 18 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving S-methoprene as an existing active  substance for use in biocidal products for 
product-type 18 
(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 
products
1, and in particular the third subpa ragraph of Article 89(1) thereof, 
Whereas: (1) Commission Regulati on (EC) No 1451/2007
2 establishes a list of active substances to 
be assessed, with a view to their possible in clusion in Annex I, IA or IB to Directive 
98/8/EC of the European Pa rliament and of the Council3. That list includes S-
methoprene. 
(2) S-methoprene has been evaluated in accordance with Article 11(2) of Directive 
98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to  that Directive, which corresponds to 
product-type 18 as defined in Anne x V to Regulation (EU) No 528/2012. 
(3) Ireland was designated as Rapporteur Member State and submitted the competent 
authority report, together  with a recommendation, to the Commission on 29 October 
2010 in accordance with Article 14(4) a nd (6) of Regulati on (EC) No 1451/2007. 
(4) The competent authority report was re viewed by the Member States and the 
Commission. In accordance with Article 15 (4) of Regulation (EC) No 1451/2007, the 
findings of the review were incorporated, within the Standing Committee on Biocidal 
Products on [date SCB], in an assessment report. 
(5) It appears from that repor t that biocidal products used for product-type 18 and 
containing S-methoprene may be expected to  satisfy the requirements laid down in 
Article 5 of Directive 98/8/EC. 
(6) It is therefore appropriate to approve S-methoprene for use in biocidal products for 
product-type 18. 
(7) Since the evaluation did not a ddress nanomaterials, the appr oval should not cover such 
materials pursuant to Article 4( 4) of Regulation (EU) No 528/2012. 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Regulation (EC) No 1451/2007 of 4 Decem ber 2007 on the second phase of the 10-year 
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).  
3 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 (8) 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.  
(9) 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 
S-methoprene shall be approved as an active substance for use in biocidal products for 
product-type 18, subject to th e specifications and conditi ons 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
4 Date of 
approval Expiry date 
of approval Product 
type Specific conditions5 
S-methoprene 
 IUPAC Name :  
Isopropyl-(2E,4E,7S)-11-methoxy-
3,7,11-trimethyl-2,4-dodecadienoate  
EC No : N/A 
CAS No : 65733-16-6 
 950 g/kg 1 
September 
2015  31 August 
2025  18 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) When formulated as a bait, 
products shall contain an aversive agent. 
(2) 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 
                                                 
4 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 
5 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  
6 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). 
7 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 5   EN Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
4 Date of 
approval Expiry date 
of approval Product 
type Specific conditions5 
the European Parliament and of 
the Council6 or Regulation (EC) 
No 396/2005 of the European 
Parliament and of the Council7 
shall be verified, and any appropriate risk mitigation 
measures shall be taken to 
ensure that the applicable MRLs 
are not exceeded.