EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SCBP42-Doc.3.1 
[…](2014) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving N,N-Methylenebismor pholine as an active substance for use in biocidal 
products for product-types 6 and 13 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving N,N-Methylenebismorpholine as an  existing active substance for use in 
biocidal products for product-types 6 and 13 
(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 Delegated Regul ation (EU) No 1062/2014
2 establishes a list of existing 
active substances to be evaluated for thei r possible approval for use in biocidal 
products.  
(2) That list includes N,N- Methylenebismorpholine. 
(3) N,N-Methylenebismorpholine has been evalua ted in accordance with Article 16(2) of 
Directive 98/8/EC of the European  Parliament and of the Council3  for use in product-
type 6, in-can preservatives, and product-type 13, metalwor king-fluid preservatives, as 
defined in Annex V to that Directive, which correspond respectively to product-types 
6 and 13 as defined in Annex V to Regulation (EU) No 528/2012. 
(4) Austria was designated as evaluating competent authority and submitted the 
assessment reports, together with its reco mmendations, to the Commission on 25 July 
2013 in accordance with paragraphs 4 and 6 of Article 14 of Commission 
Regulation (EC) No 1451/20074. 
(5) In accordance with Article 7(1)(b) of Commission Delegate d Regulation (EU) 
No 1062/2014,5 the opinions of the European Chem icals Agency were formulated on 3 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for 
the systematic examination of all existing active substan ces contained in biocidal products referred to in 
Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 
1). 
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).  
4 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). 
5 Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the 
systematic examination of all existing active substances contained in biocidal products referred to in 
Regulation (EU) No 528/2012 of the European Parliament and of the Council Text with EEA relevance 
(OJ L 294, 10.10.2014, p. 1).   
EN 3   EN October 2014 by the Biocidal Product Committee, having regard to the conclusions of 
the evaluating competent authority.  
(6) According to those opinions, biocidal pr oducts used for produc t-types 6 and 13 and 
containing N,N-Methylenebismorpholine may be  expected to satisfy the requirements 
laid down in Article 5 of Directive 98/8/EC  of the European Parliament and of the 
Council6 provided that certain specifications and conditions relating to its use are 
satisfied.  
(7) It is therefore appropriate to approve N,N-Methylenebismo rpholine for use in biocidal 
products for product-types 6 and 13 subject to  compliance with the specific conditions 
in the Annex. 
(8) The opinions conclude that N,N-Methylenebismorpholine meets the criteria for 
classification as carcinogenic category 1B  in accordance with Regulation (EC) No 
1272/2008 of the European Parliament and of the Council7.  
(9) Since pursuant to Article 90( 2) of Regulation (EU) No 528/2012, substances for which 
the Member States' evaluation has not been completed by 1 September 2013 should be approved in accordance with Directive 98/8/EC, tthe period of approval should be 5 years in accordance with the practice  established under that Directive.  
(10) For the purposes of Arti cle 23 of Regulation (EU) No 528/2012 however, N,N-
Methylenebismorpholine meets the conditions of Article 10(1)(a) of that Regulation 
and should therefore be consider ed a candidate for substitution.. 
(11)  
(12) 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 th e new requirements.  
(13) 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 
N,N-Methylenebismorpholine is approved as an active substance for use in biocidal products 
for product-types 6 and 13, subjec t to the specificati ons and conditions 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. 
                                                
 
6 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) . 
7 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtures, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 
1).  
EN 4   EN Done at Brussels, 
 For the Commission 
 The President