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EU formally renews active substances Forchlorfenuron and Zoxamide. Herbicide Flurtamone will be withdrawn from EU market Featured

The EU Recently published official announcements approving the re-approval of the application of the plant growth regulator Forchlorfenuron (CAS No 68157-60-8) and the fungicide Zoxamide (CAS No 156052-68-5) under Regulation (EC) 1107/2009. The approved Active Substance Checklist (EU) 540/2011 will be amended accordingly. A detailed description can be found in the COMMISSION IMPLEMENTING REGULATION (EU) 2018/679 and (EU) 2018/692.

A brief summary of the approval notices is provided below:

Common Denomination

ID Number

IUPAC Name

Purity(1)

Date of approval

Expiration of approval

Forchlorfenuron

CAS No 68157-60-8

CIPAC No 633

1-(2-chloro-4-pyridyl)- 3-phenylurea

≥ 978 g/kg

1 June 2018

31 May 2033

Zoxamide

CAS No 156052-68-5

CIPAC No 640

(RS)-3,5-dichloro-N-(3- chloro-1-ethyl-1-methyl- 2-oxopropyl)-p-toluamide

≥ 953 g/kg

1 July 2018

30 June 2033

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

More importantly, the authorisations for products containing these two substances will need to be renewed within 3 months after the official approval in accordance with Article 43 of Regulation (EC) 1107/2009. Applications for Forchlorfenuron will be required by 31 August 2018 and 30 September 2018 for Zoxamide.

Furthermore, from the WTO we have learntthat the EC will not renew its approval of the active substance Flurtamone. The official notice will come out on the Official Journal of the European Union this autumn.

Flurtamone was first approved on 1 January, 2004 under Directive 91/414/ EEC, and is expected to expire on 31 October, 2018. The re-evaluation is conducted under the new regulation (EC) No 1107/2009.

During the evaluation, the information available indicates that the approval criteria as set out in According to Article 4(1) to (3) of Regulation (EC) No 1107/2009, residues of plant protection products consistent with good plant protection practices and under normal conditions of use should not have any harmful effects on human health or the environment. These requirements, as it was announced, had not been met.

During the evaluation and peer-review of Flurtamone, a number of concerns and areas that could not be completely assessed were identified. These are detailed in the conclusion of the European Food Safety Authority (EFSA).

In particular, the mutagenic potential of Flurtamone could not be fully excluded, and thus no final health-based reference values could be set. This situation prevented the consumer and non-dietary risk assessments from actually being conducted.

In addition, EFSA stated that the overall consumer risk assessment for exposure to metabolite Trifluoroacetic acid, predicted to occur in groundwater in all pertinent scenarios and as a residue in plants, could not be finalised due to a number of deficiencies found in the dossier. It was likewise mentioned that the assessment of endocrine disrupting properties could not be completed based on the available studies.

As these issues and their reporting suggest, Flurtamone has been unable to meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and thus will at present not be approved.

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