Commission Implementing Regulation (EU) 2015/1730 of 28 September 2015 approving hydrogen peroxide as an existing active substance for use in biocidal products for product-types 1, 2, 3, 4, 5 and 6 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2015/1730
• Articles: 3

Article 1

Hydrogen peroxide is approved as an active substance for use in biocidal products for product-types 1, 2, 3, 4, 5 and 6, subject to the specifications 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 .

Schedules & Appendices

ANNEX

ANNEX

Common Name

IUPAC Name

Identification Numbers

Minimum degree of purity of the active substance  ( 1 )

Date of approval

Expiry date of approval

Product type

Specific conditions

Hydrogen peroxide

IUPAC Name:

Hydrogen peroxide

EC No: 231-765-0

CAS No: 7722-84-1

The active substance as manufactured is an aqueous solution containing 350 - < 700 g/kg (35 - < 70 % by weight) hydrogen peroxide.

The theoretical (calculated) dry weight specification: minimum purity of hydrogen peroxide is 995 g/kg (99,5 % by weight).

1 February 2017

31 January 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)

Authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013 on the marketing and use of explosive precursors.

(2)

For professional users, safe operational procedures and appropriate organisational measures shall be established for the handling of concentrated products.

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)

Authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013 on the marketing and use of explosive precursors.

(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

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)

Authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013 on the marketing and use of explosive precursors.

(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)

Authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013 on the marketing and use of explosive precursors.

(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 hydrogen peroxide 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)

Authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013 on the marketing and use of explosive precursors.

(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)

Authorisations of biocidal products shall be without prejudice to Regulation (EU) No 98/2013 on the marketing and use of explosive precursors.

(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.

( 1 )   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 16(2) of Directive 98/8/EC. 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.