Commission Implementing Regulation (EU) 2015/407 of 11 March 2015 approving propan-2-ol as an active substance for use in biocidal products for product-types 1, 2 and 4 Text with EEA relevance

• CELEX: Implementing Regulation (EU) 2015/407
• Articles: 3

Article 1

Propan-2-ol shall be approved as an active substance for use in biocidal products for product-types 1, 2 and 4, 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  ( 2 )

Propan-2-ol

IUPAC Name:

2-Propanol

EC No: 200-661-7

CAS No: 67-63-0

99 % w/w

1 July 2016

30 June 2026

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.

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.

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.

For biocidal products, authorisations are subject to the following conditions:

(1)

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  ( 3 ) or Regulation (EC) No 396/2005 of the European Parliament and of the Council  ( 4 ) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded;

(2)

biocidal products containing propan-2-ol 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.

( 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 8 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.

( 2 )   For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/environment/chemicals/biocides/index_en.htm

( 3 )   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, 16.6.2009, p. 11 ).

( 4 )   Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides 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 ).