EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
CA-Sept13-Doc.4.4 
[…](2013) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
to approve ethyl butylacetylamin opropionate as an existing active substance for use in 
biocidal products for product-type 19 
(Text with EEA relevance) 
 EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
to approve ethyl butylacetylamin opropionate as an existing active substance for use in 
biocidal products for product-type 19 
(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 ethyl 
butylacetylaminopropionate. 
(2) Ethyl butylacetylaminopropionate has been ev aluated in accordance with Article 11(2) 
of Directive 98/8/EC for use in product-type  19, repellents and attractants, as defined 
in Annex V to that Directive, which corre sponds to product-type 19 as defined in 
Annex V to Regulati on (EU) No 528/2012. 
(3) Belgium was designated as Rapporteur Member State and submitted the competent 
authority report, together with a reco mmendation, to the Commission on 5 November 
2009 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 in  an assessment report reviewed within the 
Standing Committee on Biocidal  Products on [date SCB]. 
(5) According to that assessment report, bioc idal products used for product-type 19 and 
containing ethyl butylacetylaminopropionate  may be expected to satisfy the 
requirements laid down in Article 5 of Di rective 98/8/EC, provide d that the certain 
specifications and conditions rela ting to its useare satisfied. 
(6) It is therefore appropriate to approve ethyl butylacetylaminopropionate for use in 
biocidal products for product- type 19 subject to complian ce with such specifications 
and conditions. 
                                                 
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 (7) Since the evaluation did not a ddress nanomaterials, the appr oval should not cover such 
materials in accordance with Article 4(4) of Regulation (EU) No 528/2012. 
(8) A reasonable period should be allowed to elapse before an active substance is 
approved, in order to permit interested pa rties to take the preparatory measures 
necessary to meet the ne w requirements laid down.  
(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 
Ethyl butylacetylaminopropionate sh all be approved as an active substance for use in biocidal 
products for product-type 19, subjec t to the specifications and c onditions 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 
Ethyl 
butylacetylaminopropi
onate IUPAC Name :  
3-(N-acetyl-N-butyl )aminopropionic acid 
ethyl ester  
EC n° : 257-835-0  
CAS n° : 52304-36-6 980 g/kg 1 
November 
2015 31 October 
2025
 19 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 
condition : 
(1) Primary exposure of humans to 
the product shall be minimized by considering and applying 
appropriate risk mitigation 
measures, including, where applicable, instructions on the 
amount and the frequency with 
which the product may be applied to human skin. 
(2) Products must contain deterrents 
for ingestion. 
 
                                                 
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 .