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 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 conditions 
N,N-
Methylenebismorpholine  IUPAC Name :  
N,N-Methylenebismorpholine EC n° : 227-062-3 
CAS n° : 5625-90-1 92.1% w/w 1 October 
2016 30 
September 
2021 6 N,N-Methylenebismor pholine is considered a candidate for 
substitution in accordance with Article 10(1)(a) of Regulation 
(EU) No 528/2012. 
The product assessment shall pay particular attention to the 
exposures, the risks and the e fficacy linked to any uses 
covered by an application for authorisation, but not 
addressed in the Union level risk assessment of the active 
substance. 
For biocidal products, authorisations are subject to the 
following conditions: 
(1) Mixing and loading of products to formulation 
vessels shall be automated, unless it can be 
demontrated at product authorization that potential 
exposure of skin, eye and respiratory tracts to N,N-
Methylenebismorpholine can be reduced to an 
acceptable level by other means. 
                                                            
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 Article 16(2) of 
Directive 98/8/EC. The active subs tance 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 
 Common Name IUPAC Name 
Identification Numbers Minimum degree of 
purity of the active 
substance1  Date of 
approval Expiry date 
of approval Product 
type Specific conditions 
 
For treated articles, the following condition applies :  Where a treated article has been treated with or intentionally 
incorporates one or more biocidal products containing N,N-Methylenebismorpholine and where necessary due to the possibility of skin contact as well as the release of N,N-
Methylenebismorpholine under normal conditions of use of the article, the person responsible for placing the article on 
the market shall ensure  that the label provides information on 
the risk of skin sensitizatio n, as well as the information 
referred to in the second paragraph of Article 58(3) of Regulation (EU) No 528/2012. 
13 N,N-Methylenebismorpholine is considered a candidate for 
substitution in accordance with Article 10(1)(a) of Regulation 
(EU) No 528/2012. 
The product assessment shall pay particular attention to the 
exposures, the risks and the e fficacy linked to any uses 
covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. 
For biocidal products, authorisations are subject to the 
following conditions:  
 
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 conditions 
(1) For 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. 
(2) Mixing and loading of products to formulation 
vessels shall be automated, unless it can be 
demontrated at product authorization that potential exposure of skin, eye and respiratory tracts to N,N-
Methylenebismorpholine can be reduced to an 
acceptable level by other means.