LegalizeCommission Implementing Regulation (EU) 2019/1085 of 25 June 2019 renewing the approval of the active substance 1-methylcyclopropene, 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, and amending the Annex to Commission Implementing Regulation (EU) 2015/408 (Text with EEA relevance.)
Article 1
Renewal of the approval of active substance
The approval of the active substance 1-methylcyclopropene, as specified in Annex I, is renewed 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
Amendment to Implementing Regulation (EU) 2015/408
The entry for 1-methylcyclopropene is deleted from the Annex to Implementing Regulation (EU) 2015/408.
Article 4
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 August 2019.
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 |
|---|---|---|---|---|---|
| 1-methylcyclopropene CAS No 3100-04-7 CIPAC No 767 | 1-methylcyclopropene | ≥ 980 g/kg (technical concentrate) The following impurities are of toxicological concern and must not exceed the following levels in the technical material (technical concentrate): — 1-chloro-2-methylpropene: maximum of 0,2 g/kg, — 3-chloro-2-methylpropene: maximum of 0,2 g/kg. For 1-methylcyclopropene generated in situ, Heptane and methylcyclohexane are toxicologically relevant impurities. These impurities should remain below 10 %. | 1 August 2019 | 31 July 2034 | Only uses as plant growth regulator for post-harvest storage in sealable warehouse may be authorised. 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 1-methylcyclopropene, 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 groundwater, when the substance is applied in regions with vulnerable soil and climatic conditions. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards the presence of methallyl alcohol in soil and aquatic compartments and, if formed in relevant amounts, information on its toxicological properties and potential risk to aquatic and soil organisms and as regards the effect of water treatment processes on the nature of residues present in drinking water. The confirmatory information shall be submitted by 27 May 2027. |
| (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 117 on 1-methylcyclopropene 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 ‘136 1-methylcyclopropene CAS No 3100-04-7 CIPAC No 767 1-methylcyclopropene ≥ 980 g/kg (technical concentrate) The following impurities are of toxicological concern and must not exceed the following levels in the technical material (technical concentrate): — 1-chloro-2-methylpropene: maximum of 0,2 g/kg, — 3-chloro-2-methylpropene: maximum of 0,2 g/kg. For 1-methylcyclopropene generated in situ, Heptane and methylcyclohexane are toxicologically relevant impurities. These impurities should remain below 10 %. 1 August 2019 31 July 2034 Only uses as plant growth regulator for post-harvest storage in sealable warehouse may be authorised. 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 1-methycyclopropene, and in particular Appendices I and II thereto, shall be taken into account.’ (1) Further details on identity and specification of active substance are provided in the renewal report.
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