http://www.legislation.gov.uk/id/eur/2017/2001

Commission Implementing Regulation (EU) 2017/2001

of 8 November 2017

approving propan-1-ol as an existing active substance for use in biocidal products of product-type 1, 2 and 4

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products1, and in particular the third subparagraph of Article 89(1) thereof,

Whereas:

(1)

Commission Delegated Regulation (EU) No 1062/20142 establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes propan-1-ol.

(2)

Propan-1-ol has been evaluated for use in products of product-type 1, human hygiene, product-type 2, disinfectants and algaecides not intended for direct application to humans or animals, and product-type 4, food and feed area, as described in Annex V to Regulation (EU) No 528/2012.

(3)

Germany was designated as evaluating competent authority and submitted the assessment reports together with its recommendations on 18 July 2016.

(4)

In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 27 April 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

(5)

According to those opinions, biocidal products of product-types 1, 2 and 4 and containing propan-1-ol may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

(6)

It is therefore appropriate to approve propan-1-ol for use in biocidal products of product-types 1, 2 and 4, subject to compliance with certain specifications and conditions.

(7)

A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

Propan-1-ol is approved as an active substance for use in biocidal products of 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.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 8 November 2017.

For the Commission

The President

Jean-Claude Juncker

ANNEX

Common Name	IUPAC NameIdentification Numbers	Minimum degree of purity of the active substance3	Date of approval	Expiry date of approval	Product type	Specific conditions
Propan-1-ol	IUPAC Name: Propan-1-ol EC No: 200-746-9 CAS No: 71-23-8	≥ 995 g/kg	1 May 2019	30 April 2029	1	The authorisations of biocidal products are subject to the following conditions: (1) the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance; (2) in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users.
2	The authorisations of biocidal products are subject to the following condition: the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.
4	The authorisations of biocidal products are subject to the following conditions: (1) the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance; (2) in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users; (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 Council4 or Regulation (EC) No 396/2005 of the European Parliament and of the Council5 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

Common Name

IUPAC NameIdentification Numbers

Minimum degree of purity of the active substance3

Date of approval

Expiry date of approval

Product type

Specific conditions

Propan-1-ol

IUPAC Name:

Propan-1-ol

EC No: 200-746-9

CAS No: 71-23-8

≥ 995 g/kg

1 May 2019

30 April 2029

The authorisations of biocidal products are subject to the following conditions:

(1)
the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance;
(2)
in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users.

The authorisations of biocidal products are subject to the following condition:

the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use 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)
the product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance;
(2)
in view of the risks identified for the uses assessed, the product assessment shall pay particular attention to professional users;
(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 Council4 or Regulation (EC) No 396/2005 of the European Parliament and of the Council5 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.

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).

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).