Commission Implementing Regulation (EU) 2020/2101 of 15 December 2020 renewing the approval of the active substance kieselgur (diatomaceous earth) 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) 2020/2101
• Articles: 5

Article 1 Renewal of the approval of the active substance

The approval of the active substance kieselgur (diatomaceous earth) is renewed as set out in Annex I.

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 .

It shall apply from 1 February 2021.

Schedules & Appendices

ANNEX I

ANNEX I

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

Kieselgur (Diatomaceous earth)

CAS No 6 1790-53-2

CIPAC No 647

No IUPAC name exists for kieselgur

Other synonyms:

Diatomaceous earth

Diatomite

1 000 g/kg

Minimum content of amorphous silica of 800 g/kg

The following impurity must not be exceeded in the technical material:

Crystalline silica with particle size below 10 μm – maximum of 1 g/kg

1 February 2021

31 January 2036

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on kieselgur (diatomaceous earth), and in particular Appendices I and II thereto, shall be taken into account.

Member States shall pay particular attention to the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment, in particular respiratory protective equipment, and other risk mitigation measures, where appropriate.

Only indoor use is permitted. Member States shall assess any extension of the use pattern beyond use in closed storage environments, in order to establish whether the proposed extensions of use fulfil the requirements of Article 29(1) of Regulation (EC) No 1107/2009 and of the uniform principles laid down in Commission Regulation (EU) No 546/2011  ( 2 ) . Conditions of use shall include risk mitigation measures, where appropriate.

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

( 2 )   Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products ( OJ L 155, 11.6.2011, p. 127 ).

ANNEX II

ANNEX II

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

(1)

in Part A, entry 236 on kieselgur (Diatomaceous earth) is deleted;

(2)

in Part B, the following entry is added:

No.

Common Name, Identification Numbers

IUPAC Name

Purity  ( 1 )

Date of approval

Expiration of approval

Specific provisions

‘143

Kieselgur (Diatomaceous earth)

CAS No 6 1790-53-2

CIPAC No 647

No IUPAC name exists for kieselgur

Other synonyms:

Diatomaceous earth,

Diatomite

1 000 g/kg

Minimum content of amorphous silica of 800 g/kg

The following impurity is of toxicological concern and must not exceed the following level in the technical material:

Crystalline silica with particle size below 10 μm – maximum of 1 g/kg

1 February 2021

31 January 2036

For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on kieselgur (diatomaceous earth), and in particular Appendices I and II thereto, shall be taken into account.

Member States shall pay particular attention to the protection of operators, ensuring that conditions of use include the application of adequate personal protective equipment, in particular respiratory protective equipment, and other risk mitigation measures, where appropriate.

Only indoor use is permitted. Member States shall assess any extension of the use pattern beyond use in closed storage environments, in order to establish whether the proposed extensions of use fulfil the requirements of Article 29(1) of Regulation (EC) No 1107/2009 and of the uniform principles laid down in Regulation (EU) No 546/2011. Conditions of use shall include risk mitigation measures, where appropriate.’

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