Common Name, Identification Numbers

IUPAC Name

Purity (1)

Date of approval

Expiration of approval

Specific provisions

Terbuthylazine

CAS No 5915-41-3

CIPAC No 234

N2-tert-butyl-6-chloro-N4-ethyl-1,3,5-triazine-2,4-diamine

≥ 950 g/kg

The following impurities are of toxicological concern and must not exceed the following levels in the technical material:

1 January 2012

31 December 2024

PART A

Only uses as herbicide may be authorised.

Use shall be limited to one application every three years on the same field at a maximum dose of 850 g terbuthylazine per hectare.

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 terbuthylazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 and updated by the Standing Committee on Plants, Animals, Food and Feed on 24 March 2021 shall be taken into account.

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

Conditions of use shall include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate

Number

Common name, identification numbers

IUPAC name

Purity (*1)

Date of approval

Expiration of approval

Specific provisions

‘16

Terbuthylazine

CAS No 5915-41-3

CIPAC No 234

N2-tert-butyl-6-chloro-N4-ethyl-1,3,5-triazine-2,4-diamine

≥ 950 g/kg

Impurities:

1 January 2012

31 December 2021

PART A

Only uses as herbicide 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 terbuthylazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.

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

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

(b)  the risk to mammals and earthworms.

Conditions of use shall include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate.

The applicant shall submit confirmatory information as regards:

(1)  the specification of the technical material, as commercially manufactured, by appropriate analytical data, including information on the relevance of the impurities;

(2)  the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies;

(3)  groundwater exposure assessment for the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6;

(4)  the relevance of the metabolites MT1 (N-tert-butyl-6-chloro-1,3,5-triazine-2,4-diamine), MT 13 (4-(tert-butylamino)-6-(ethylamino)-1,3,5-triazin-2-ol or 6-hydroxy-N2-ethyl-N4-tert-butyl-1,3,5-triazine-2,4-diamine), MT14 (4-amino-6-(tert-butylamino)-1,3,5-triazin-2-ol or N-tert-butyl-6-hydroxy-1,3,5-triazine-2,4-diamine), and of the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6 with respect to cancer, if terbuthylazine is classified under Regulation (EC) No 1272/2008 as “suspected of causing cancer”.

The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012, the information set out in point (3) by 30 June 2013 and the information set out in point (4) within six months from the notification of the classification decision concerning that substance.’