Commission Implementing Regulation (EU) 2017/2005 of 8 November 2017 approving margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide as an existing active substance for use in biocidal products of product-type 19 (Text with EEA relevance. )

• CELEX: Implementing Regulation (EU) 2017/2005
• Articles: 3

Article 1

Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide is approved as an active substance for use in biocidal products of product-type 19, 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

Margosa extract, cold-pressed oil of Azadirachta indica seeds without shells extracted with super-critical carbon dioxide

IUPAC Name:

Not applicable

EC No: 283-644-7

CAS No: 84696-25-3

1 000 g/kg

1 April 2019

31 March 2029

19

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 surface water, sediment and soil.

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 Council  ( 3 ) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

( 1 )   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.

( 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, 16.6.2009, 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 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 ).