Commission Implementing Regulation (EU) 2015/1192 of 20 July 2015 approving the active substance terpenoid blend QRD 460, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2015/1192
• Articles: 5

Article 1 Approval of active substance

The active substance terpenoid blend QRD 460, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

Article 2 Amendments to Implementing Regulation (EU) No 540/2011

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

Article 3 Entry into force and date of application

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 I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Terpenoid blend QRD 460

CIPAC No: 982

Terpenoid blend QRD 460 is a blend of three components:

—

α-terpinene: 1-isopropyl-4-methylcyclohexa-1,3-diene;

—

p -cymene: 1-isopropyl-4-methylbenzene;

—

d -limonene: ( R )-4-isopropenyl-1-methylcyclohexene.

The nominal concentration of each component in the active substance as manufactured should be as follows:

—

α-terpinene: 59,7 %;

—

p -cymene: 22,4 %;

—

d -limonene: 17,9 %.

Each component should have a minimum purity as follows:

—

α-terpinene: 89 %;

—

p -cymene: 97 %;

—

d -limonene: 93 %.

10 August 2015

10 August 2025

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 terpenoid blend QRD-460, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

(a)

the stability of formulations on storage;

(b)

the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;

(c)

the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;

(d)

the protection of surface water and aquatic organisms;

(e)

the protection of bees and non-target arthropods.

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

The applicant shall submit confirmatory information as regards:

(1)

the technical specification of the active substance as manufactured (5 batch analysis for the blend should be provided), supported by acceptable and validated methods of analysis. It should be confirmed that there are no relevant impurities present in the technical material;

(2)

the equivalence of the material used in the toxicological and ecotoxicological studies with the confirmed technical specification.

The applicant shall submit that information to the Commission, the Member States and the Authority by 10 February 2016.

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

ANNEX II

ANNEX II

In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

Common Name, Identification Numbers

IUPAC Name

Purity  ( *1 )

Date of approval

Expiration of approval

Specific provisions

‘84

Terpenoid blend QRD 460

CIPAC No: 982

Terpenoid blend QRD 460 is a blend of three components:

—

α-terpinene: 1-isopropyl-4-methylcyclohexa-1,3-diene;

—

p -cymene: 1-isopropyl-4-methylbenzene;

—

d -limonene: ( R )-4-isopropenyl-1-methylcyclohexene.

The nominal concentration of each component in the active substance as manufactured should be as follows:

—

α-terpinene: 59,7 %;

—

p -cymene: 22,4 %;

—

d -limonene: 17,9 %.

Each component should have a minimum purity as follows:

—

α-terpinene: 89 %;

—

p -cymene: 97 %;

—

d -limonene: 93 %.

10 August 2015

10 August 2025

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 terpenoid blend QRD-460, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

(a)

the stability of formulations on storage;

(b)

the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate;

(c)

the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions;

(d)

the protection of surface water and aquatic organisms;

(e)

the protection of bees and non-target arthropods.

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

The applicant shall submit confirmatory information as regards:

(1)

the technical specification of the active substance as manufactured (5 batch analysis for the blend should be provided), supported by acceptable and validated methods of analysis. It should be confirmed that there are no relevant impurities present in the technical material;

(2)

the equivalence of the material used in the toxicological and ecotoxicological studies with the confirmed technical specification.

The applicant shall submit that information to the Commission, the Member States and the Authority by 10 February 2016.’

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