Active substance approvals: May 2017
Brexit: Transition period
The UK has now left the EU. Your health and safety responsibilities have not changed in the transition period.
Regulatory Update: 07/2017
Issued: 12th May 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;
- Beauveria bassiana strain 147
- Bacillus amyloliquefaciens strain FZB21 and Beauveria bassiana strain NPP111B005 – Low risk substances
- flazasulfuron, mesosulfuron, mesotrione and cyhalofop-butyl – Renewal of approval
- Coniothyrium minitans strain CON/M/91-08 – Low risk active substance renewal
- fluroxypyr and diflubenzuron – Amended conditions of approval
- non-approval of the active substance orthosulfamuron
- withdrawal of approval of the active substance methyl nonyl ketone
Bacillus amyloliquefaciens strain FZB24, Beauveria bassiana strain NPP111B005 and Coniothrium minitans strain CON/91-08 low risk substances
Bacillus amyloliquefaciens strain FZB24, Beauveria bassiana strain NPP111B005 and Coniothyrium minitans strain CON/M/91-08 are low-risk active substances pursuant to Article 22 of Regulation (EC) No 1107/2009. Bacillus amyloliquefaciens strain FZB24, Beauveria bassiana strain NPP111B005 and Coniothyrium minitans strain CON/M/91 are not substances of concern and fulfil the conditions set in point 5 of Annex II to Regulation (EC) No 1107/2009.
Flazasulfuron, mesosulfuron, mesotrione and cyhalofop-butyl renewal of approvals
These substances were considered under the second and third stages of the renewal programme (governed by Commission Regulations 1141/2010 and 844/2012 respectively). Authorisations for products containing these substances will need to be renewed in accordance with Article 43 of Regulation (EC) 1107/2009, with applications required by 31 August 2017 (mesotrione), 30 September 2017 (cyhalofop and mesosulfuron) and 31 October (flazasulfuron). The Guidance on UK Procedures for product renewal applications provides further details.
Fluroxypyr and diflubenzuron amendment of approvals
For fluroxypyr the column 'Purity', of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:
≥ 950 g/kg (fluroxypyr-meptyl)
The following manufacturing impurity is of toxicological concern and must not exceed the following amount in the technical material:
N-methyl-2-pyrrolidone (NMP): < 3 g/kg'
The column ‘Specific provisions’ of the Annex to Implementing Regulation (EU) No 540/2011 is replaced by the following:
Only uses as herbicide may be authorised.
For the implementation of the uniform principles referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on fluroxypyr, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 23 March 2017 shall be taken into account.
In this overall assessment, Member States must pay particular attention to:
- the potential contamination of groundwater by metabolite fluroxypyr pyridinol, when the active substance is applied in regions with alkaline or vulnerable soil or with vulnerable climatic conditions;
- the risk to aquatic organisms
Conditions of authorisation shall include risk mitigation measures, where appropriate.'
For diflubenzuron under Part A of the ‘specific provisions’ A of the Annex to Implementing Regulation (EU) No 540/2011, the text is replaced by the following:
Only uses as insecticide in non-edible crops may be authorised. Under Part B of the ‘specific provisions’ the following is included:‘Member States shall ensure that crops treated with diflubenzuron do not enter the food and feed chain.’
It has not been demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing orthosulfamuron satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC. Orthosulfamuron should therefore not be approved pursuant to Article 13(2) of Regulation (EC) No 1107/2009.
Methyl nonyl ketone withdrawal of approval
Commission Implementing Regulation (EU) No 608/2012 required that the notifier at whose request methyl nonyl ketone has been included provide further confirmatory information on (a) the specification of the material tested in mammalian toxicology and ecotoxicology studies, (b) the specification with supporting batch data and validated methods of analysis, (c) an appropriate assessment of the fate and behaviour of that substance and its potential transformation products in the environment and (d) the risk to aquatic and to soil living organisms. This information was due by 30 April 2013 for points (a) and (b) and by 31 December 2015 for points (c) and (d).
The notifier failed to submit the confirmatory information on points (c) and (d) by 31 December 2015. The notifier also failed to reply to the letter from the Commission giving him the opportunity to explain his position before any decision to withdraw the substance would be taken.
Consequently, it is appropriate to withdraw the approval of methyl nonyl ketone.