1 
 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 
Glutaraldehyde IUPAC Name :  
1,5-pentanedial EC n° : 203-856-5 
CAS n° : 111-30-8 950 g/kg dry weight 
(95% ) 1 October 
2016 30 
September 
2026 2 Glutaraldehyde is considered a candidate for substitution in 
accordance with Article 10(1)(b) 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) For industrial or 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. 
                                                            
1 The purity indicated in this column was the minimum degree of purity of the active substance us ed for the evaluation made in a ccordance with 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 
(2) Products can not be applied by wiping unless it can 
be demonstrated at product authorisation that there 
is no unacceptable risk. 
 
For treated articles, the following condition applies :  
Where a treated article has been treated with or intentionally 
incorporates one or more biocidal products containing glutaraldehyde and wh ere necessary due to the possibility of 
skin contact as well as the release of glutaraldehyde 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 sensitization, as 
well as the information referred to in the second paragraph of Article 58(3) of Regulation (EU) No 528/2012. 
3 Glutaraldehyde is considered a candidate for substitution in 
accordance with Article 10(1)(b) 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  
 
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 
following conditions:
(1) For industrial or 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) The application by fogging of  shall be restricted to 
professionals adequately trained to use them. 
(3) 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
2 or Regulation (EC) No 
396/2005 of the European Parliament and of the 
Council3 shall be verified, and any appropriate risk 
mitigation measures shall be taken to ensure that the 
applicable MRLs are not exceeded. 
 
For treated articles, the following condition applies :  
Where a treated article has been treated with or intentionally 
                                                            
2  Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the 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). 
3  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pe sticides 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).  
 
4 
 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 
incorporates one or more biocidal products containing 
glutaraldehyde and wh ere necessary due to the possibility of 
skin contact as well as the release of glutaraldehyde 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 sensitization, as 
well as the information referred to in the second paragraph of 
Article 58(3) of Regulation (EU) No 528/2012. 
4 Glutaraldehyde is considered a candidate for substitution in 
accordance with Article 10(1)(b) 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) For industrial or 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) For products that may lead to residues in food or  
 
5 
 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 
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 Counci l or Regulation (EC) No 
396/2005 of the European Parliament and of the 
Council shall be verified, and any appropriate risk 
mitigation measures shall be taken to ensure that the 
applicable MRLs are not exceeded. 
(3) Products shall not be incorporated in materials and 
articles intended to come into contact with food 
within the meaning of Article 1(1) of Regulation (EC) 
No 1935/2004, unless the Commission has 
established specific limits on the migration of 
propan-2-ol into food or it has been established 
pursuant to that Regulation that such limits are not 
necessary. 
 
For treated articles, the following condition applies :  
Where a treated article has been treated with or intentionally 
incorporates one or more biocidal products containing 
glutaraldehyde and wh ere necessary due to the possibility of 
skin contact as well as the release of glutaraldehyde 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 sensitization, as 
well as the information referred to in the second paragraph of 
Article 58(3) of Regulation (EU) No 528/2012.  
 
6 
 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 
6 Glutaraldehyde is considered a candidate for substitution in 
accordance with Article 10(1)(b) 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) For industrial or 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) Glutaraldehyde shall not be used in treated articles, 
or in biocidal products intended for non-professional 
users at a concentration equal to or higher than 0.1% 
unless exposure can be reduced to an acceptable 
level by other means than the wearing of personal 
protective equipment. 
(3) In the view of the risks to the environment, products 
shall not be authorized for the preservation of 
drilling and cementing fluids unless it can be  
 
7 
 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 
demonstrated that the product will not lead to an 
unacceptable risk. 
 
For treated articles, the following condition applies :  
Where a treated article has been treated with or intentionally 
incorporates one or more biocidal products containing 
glutaraldehyde and wh ere necessary due to the possibility of 
skin contact as well as the release of glutaraldehyde 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 sensitization, as 
well as the information referred to in the second paragraph of 
Article 58(3) of Regulation (EU) No 528/2012. 
11 Glutaraldehyde is considered a candidate for substitution in 
accordance with Article 10(1)(b) 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) For industrial or professional users, safe operational  
 
8 
 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 
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) In the view of the risks to the environment, products 
shall not be authorised for the use in small open 
recirculating cooling systems, unless data is 
submitted for product authorisation to demonstrate that the use of the product will not lead to an  
unacceptable risk for soil and surface water in 
particular. 
(3) In the view of the risks to the environment, products 
shall not be authorized for the preservation of 
hydrotesting water unless it can be demonstrated 
that the use of the product will not lead to an 
unacceptable risk. 
12 Glutaraldehyde is considered a candidate for substitution in 
accordance with Article 10(1)(b) 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  
 
9 
 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 
following conditions: 
(1) For industrial or 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) In the view of the risks to the environment, products 
shall not be authorised for the use in pulp or paper 
mills which are not connected to a waste water 
treatment plant unless it is demonstrated that the 
use of the product will not lead to an unacceptable 
risk. 
 
For treated articles, the following condition applies :  
Where a treated article has been treated with or intentionally 
incorporates one or more biocidal products containing glutaraldehyde and wh ere necessary due to the possibility of 
skin contact as well as the release of glutaraldehyde 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 sensitization, as 
well as the information referred to in the second paragraph of 
Article 58(3) of Regulation (EU) No 528/2012.