Commission Implementing Regulation (EU) No 608/2012 of 6 July 2012 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substances denathonium benzoate, methyl nonyl ketone and plant oils/spearmint oil Text with EEA relevance

• CELEX: Implementing Regulation (EU) No 608/2012
• Articles: 3

Article 1

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

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 .

It shall apply from 1 November 2012.

Schedules & Appendices

ANNEX

ANNEX

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

(1)

Row 226 on the active substance denathonium benzoate is replaced by the following

Number

Common Name, Identification Numbers

IUPAC Name

Purity  ( *1 )

Date of approval

Expiration of approval

Specific provisions

‧226

Denathonium benzoate

CAS No 3734-33-6

CIPAC No 845

Benzyldiethyl[[2,6-xylylcarbamoyl]methyl]ammonium benzoate

≥ 975g/kg

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

In assessing applications to authorise plant protection products containing denathonium benzoate for uses other than brushing with automatic rolling equipment in forestry, Member States shall pay particular attention to the criteria in Article 4(3) of Regulation (EC) No 1107/2009, and shall ensure that any necessary data and information is provided before such an authorisation is granted.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on denathonium benzoate (SANCO/2607/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

In this overall assessment Member States must pay particular attention to the protection of the operators. Authorised conditions of use must prescribe the application of adequate personal protective equipment.

Conditions of use shall include, where appropriate, risk mitigation measures.‧

(2)

Row 238 on the active substance methyl nonyl ketone is replaced by the following:

Number

Common Name, Identification Numbers

IUPAC Name

Purity  ( *2 )

Date of approval

Expiration of approval

Specific provisions

‧238

Methyl nonyl ketone

CAS No 112-12-9

CIPAC No 846

Undecan-2-one

≥ 975g/kg

1 September 2009

31 August 2019

PART A

Only uses as repellent may be authorised.

PART B

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on methyl nonyl ketone (SANCO/2619/2008) and in particular Appendices I and II thereof,as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures. Contact with food and feedcrops shall be avoided.

The notifier shall submit confirmatory information as regards:

(a)

the specification of the material tested in the mammalian toxicology and ecotoxicology studies;

(b)

the specification with suporting batch data and validated methods of analysis;

(c)

an appropriate assessment of the fate and behaviour of methyl nonyl ketone and potential transformation products in the environment;

(d)

the risk to aquatic and to soil living organisms.

The notifier shall submit to the Commission, the Member States and the Authority the information set out in points (a) and (b) by 30 April 2013 and the information set out in points (c) and (d) by 31 December 2015.‧

(3)

Row 243 on the active substance plant oils/spearmint oil is replaced by the following:

Number

Common Name, Identification Numbers

IUPAC Name

Purity  ( *3 )

Date of approval

Expiration of approval

Specific provisions

‧243

Plant oils/spear mint oil

CAS No 8008-79-5

CIPAC No 908

Spearmint oil

≥ 550 g/kg as (R)-Carvone

1 September 2009

31 August 2019

PART A

Only uses as plant growth regulator for postharvest treatment of potatoes may be authorised.

Member States shall ensure that authorisations provide that hot fogging is performed exclusively in professional storage facilities and that the best available techniques are applied to exclude the release into the environment of the product (fogging mist) during storage, transport, waste disposal and application.

PART B

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the amended review report on plant oils/spearmint oil (SANCO/2624/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 1 June 2012 shall be taken into account.

Conditions of use shall include, where appropriate, risk mitigation measures.‧

( *1 )   Further details on identity and specification of active substance are provided in their review report.

( *2 )   Further details on identity and specification of active substance are provided in their review report.

( *3 )   Further details on identity and specification of active substance are provided in their review report.