Commission Implementing Regulation (EU) No 154/2014 of 19 February 2014 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance extract from tea tree Text with EEA relevance

Amendment to Implementing Regulation (EU) No 540/2011

Article 1

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

Transitional measures

Article 2

Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary amend or withdraw existing authorisations for plant protection products containing extract from tea tree as active substance by 12 September 2014.

Grace period

Article 3

Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire on 12 September 2015 at the latest.

Entry into force

Article 4

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

ANNEXSupplementary provisions

ANNEX In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 228 on the active substance extract from tea tree is replaced by the following: Number Common Name, Identification Numbers IUPAC Name Purity  ( *1 ) Date of approval Expiration of approval Specific provisions ‘228 Extract from tea tree CAS No Tea Tree Oil 68647-73-4 Main components:   terpinen-4-ol 562-74-3   γ-terpinene 99-85-4   α-terpinene 99-86-5   1,8-cineole 470-82-6 CIPAC No 914 Tea Tree Oil is a complex mixture of chemical substances.   Main components:   terpinen-4-ol ≥ 300 g/kg   γ-terpinene ≥ 100 g/kg   α-terpinene ≥ 50 g/kg   1,8-cineole ≥ 1 g/kg   Relevant impurity: Methyl eugenol: maximum 1 g/kg of the technical material 1 September 2009 31 August 2019 PART A Only uses as fungicide in greenhouse 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 extract from tea tree (SANCO/2609/2008 final) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 13 December 2013 shall be taken into account. In this overall assessment Member States shall pay particular attention to — the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment, where appropriate; — the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions; — the protection of surface water and aquatic organisms; — the protection of honey bees, non-target arthropods, earthworms and non-target micro- and macro-organisms. Conditions of use shall include risk mitigation measures, where appropriate. The notifier shall submit confirmatory information as regards: (a) the plant metabolism and consumer exposure; (b) the toxicity of the compounds that constitute the extract and the relevance of possible impurities other than methyl eugenol; (c) the groundwater exposure for the less strongly absorbed components that constitute the extract and for potential soil transformation products; (d) the effects on biological methods of sewage treatment. The notifier shall submit to the Commission, the Member States and the Authority that information by 30 April 2016 at latest.’ ( *1 )   Further details on identity and specification of active substance are provided in their review report.