LegalizeCommission Implementing Regulation (EU) 2017/1506 of 28 August 2017 renewing the approval of the active substance maleic hydrazide 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. )
Article 1
Renewal of the approval of the active substance
The approval of the active substance maleic hydrazide 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 November 2017 except for the provision concerning hydrazine content specified in column ‘Purity’ of the table in Annex I, which shall apply from 1 November 2018.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
| Common Name, Identification Numbers | IUPAC Name | Purity (1) | Date of approval | Expiration of approval | Specific provisions |
|---|---|---|---|---|---|
| Maleic hydrazide CAS No 123-33-1 CIPAC No 310 | 6-hydroxy-2H-pyridazin-3-one | ≥ 979 g/kg The impurity hydrazine shall not exceed 0,028 mg/kg in the technical material. | 1 November 2017 | 31 October 2032 | 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 maleic hydrazide, and in particular Appendices I and II thereto, as well as its addendum, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of consumers; — the operator and worker safety; the conditions of the use shall include the application of adequate personal protective equipment. Conditions of use shall include risk mitigation measures, where appropriate. |
| (1) Further details on identity and specification of active substance are provided in the renewal report. |
ANNEX II
The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) in Part A, entry 52 on maleic hydrazide is deleted;
(2) in Part B, the following entry is added: Number Common Name, Identification Numbers IUPAC Name Purity (1) Date of approval Expiration of approval Specific provisions ‘117 Maleic hydrazide CAS No 123-33-1 CIPAC No 310 6-hydroxy-2H-pyridazin-3-one ≥ 979 g/kg Until 1 November 2018, the impurity hydrazine shall not exceed 1 mg/kg in the technical material. From 1 November 2018, the impurity hydrazine shall not exceed 0,028 mg/kg in the technical material. 1 November 2017 31 October 2032 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 maleic hydrazide, and in particular Appendices I and II thereto, shall be taken into account. In this overall assessment Member States shall pay particular attention to: — the protection of consumers, — the operator and worker safety; the conditions of the use should include the application of adequate personal protective equipment. Member States shall ensure, where appropriate, that the label of the treated crops includes the indication that the crops were treated with maleic hydrazide, and the accompanying instructions to avoid exposure of the livestock. Conditions of use shall include risk mitigation measures, where appropriate.’ (1) Further details on identity and specification of active substance are provided in the review report.