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Active substance approvals: February 2017

Regulatory Update: 04/2017
Issued: 8th February 2017

Updating your authorisation

HSE does not directly notify product authorisation holders where a change or update of a current authorisation is required because of a change by the EC to an approval of an active substance.  Authorisation holders are advised to check the EU Pesticides database where new or changes to active substance approvals and review reports are published.

Active substance approvals

At the Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) it was agreed:
To approve under Regulation (EC) 1107/2009:

Prosulfuron as a candidate for substitution

Prosulfuron was considered under the second stage of the renewal programme (governed by Commission Regulations 1141/2010).  Authorisations for products containing this substance will need to be renewed in accordance with Article 43 of Regulation (EC) 1107/2009, with applications required by 31 July 2017.  For further information see Guidance on UK Procedures for product renewal applications

Prosulfuron was also found to be a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Prosulfuron is a persistent and toxic substance in accordance with points 3.7.2.1 and 3.7.2.3 respectively, of Annex II to Regulation (EC) No 1107/2009, given that the half-life in fresh water is greater than 40 days and the long-term no-observed effect concentration for freshwater organisms is less than 0.01 mg/L.

Mild Pepino Mosaic Virus isolates VC1 and VX1

Mild Pepino Mosaic Virus isolates VC1 and VX1 were considered low-risk active substances pursuant to Article 22 of Regulation (EC) No 1107/2009.  Mild Pepino Mosaic Virus isolates VC1 and VX1 fulfil the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009.

Abamectin, buprofezin and oxyfluorfen amendment of approvals

The column ‘Specific provisions’ of abamectin, of Part A of the Annex to Implementing Regulation (EU) No 540/2011 is to be replaced by the following:

‘Only uses as insecticide, acaricide and nematicide may be authorised.’

The column ‘Specific provisions’, of buprofezin, of the Annex to Implementing Regulation (EU) No 540/2011 is to replaced by the following:

‘PART A
Only uses as insecticide and acaricide on non-edible crops 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 buprofezin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.

In this overall assessment, Member States must pay particular attention to:

Conditions of authorisation shall include risk mitigation measures, where appropriate.’

The column ‘Specific provisions’ of oxyfluorfen, the Annex to Implementing Regulation (EU) No 540/2011 is to be replaced by the following:

‘PART A

Only uses as herbicide for banded applications close to ground from autumn to early spring may be authorised, at a rate not exceeding 150 g active substance per hectare, per year.

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 oxyfluorfen, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed shall be taken into account.

In this overall assessment, Member States must pay particular attention to:

  • operator safety and ensure that conditions of use impose the application of adequate personal protective equipment where appropriate;
  • the risks to aquatic organisms, earthworm-eating mammals, soil-living macro-organisms, non-target arthropods and non-target plants.

Conditions of authorisation shall include risk mitigation measures such as no-spray buffer zones and drift reducing nozzles and shall provide for respective labelling of plant protection products. Those conditions shall include further risk mitigation measures, where appropriate.’

Acrinathrin (confirmation of approval conditions)

The review report for acrinathrin laid out specific concerns that led to the restriction of the use of acrinathrin at rates not exceeding 22,5 g/ha per application. In particular, acrinathrin is very toxic to fish and aquatic invertebrates and its acceptability on the basis of the current rates already require extensive risk mitigation.  New data provided by the applicant failed to demonstrate that the envisaged significant increase of rates, and consequently, of exposure, would result in an acceptable risk aquatic organisms.  Finally, on the basis of confirmatory information submitted by the applicant, EFSA concluded that the higher rates would induce a high risk to non-target arthropods, which further confirms that rates of application cannot be increased.  The conditions of approval of the active substance acrinathrin, as set out in Part B of the Annex to Implementing Regulation (EU) No 540/2011, are therefore retained.

Clayed charcoal, Urtica spp. and hydrogen peroxide

These were approved as basic substances for an unlimited period according to the criteria under Article 23 of Regulation (EC) 1107/2009. 

Updated 2017-03-24