OpenLegislation

Annex

United Kingdom

Common Name	IUPAC NameIdentification Numbers	Minimum degree of purity of the active substance^f1	Date of approval	Expiry date of approval	Product type	Specific conditions
The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 89(1) 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.
Peracetic acid	IUPAC Name: Peroxyethanoic acid EC No: 201-186-8 CAS No: 79-21-0	The specification is based on the starting materials hydrogen peroxide and acetic acid which are used to manufacture peracetic acid. Peracetic acid in an aqueous solution containing acetic acid and hydrogen peroxide.	1 October 2017	30 September 2027	1	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. The authorisations of biocidal products are subject to the following conditions: (1) Due to the presence of hydrogen peroxide, authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013. (2) For professional users, safe operational procedures and appropriate organisational measures shall be established.
					2	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. The authorisations of biocidal products are subject to the following conditions: (1) Due to the presence of hydrogen peroxide, authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013. (2) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (3) In view of the risks identified for the surface water, products for waste water disinfection shall not be authorised, unless it can be demonstrated that risks can be reduced to an acceptable level.
					3	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. The authorisations of biocidal products are subject to the following conditions: (1) Due to the presence of hydrogen peroxide, authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013. (2) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.
					4	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. The authorisations of biocidal products are subject to the following conditions: (1) Due to the presence of hydrogen peroxide, authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013. (2) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means. (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 peracetic acid into food or it has been established pursuant to that Regulation that such limits are not necessary.
					5	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. The authorisations of biocidal products are subject to the following conditions: (1) Due to the presence of hydrogen peroxide, authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013. (2) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.
					6	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. The authorisations of biocidal products are subject to the following conditions: (1) Due to the presence of hydrogen peroxide, authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013. (2) For professional users, safe operational procedures and appropriate organisational measures shall be established. Products shall be used with appropriate personal protective equipment where exposure cannot be reduced to an acceptable level by other means.

Annotations

Footnotes

f1: The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 89(1) 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.