Claudio Mereu Claudio Mereu

Claudio Mereu is a partner at the law firm Field Fisher Waterhouse LLP where he focuses on European Union law with an emphasis on pesticides, biocides and chemicals.

The European Commission has allowed the existing provisional approvals for Benalaxyl-M, Gamma-cyhalothrin, and Valifenalate to be extended to allow more time to complete the EU registration process. These approvals may be extended until 31 October 2013 and once extended last initially for a period of three years.

The EU approvals of Dicamba, Difenoconazole, and Imazaquin are to be amended to require the submission of additional confirmatory data. The amendments follow the completion of a detailed review by the European Food Safety Authority (EFSA).

• For Dicamba, the amendments include the requirement that Member States apply risk mitigation measures, where appropriate, to protect non-target plants. In addition, confirmatory information is required by 30 November 2013.

• For Difenoconazole, there are two relevant deadlines. First, further specification data is required by 31 May 2012. Second, further data is required by 30 November 2013 on residues of triazole metabolites, the potential for endocrine disrupting effects on fish and the chronic risk to earthworms from ai and a specific metabolite.

• For Imazaquin, confirmatory information is required on the specification on the technical material by 31 May 2012. 

In the case of Cinidon-ethyl, no application for the renewal of its EU approval was received by the deadline. As a result, the European Commission was able to formally state that the ai was no longer eligible for the approval extension granted until the end of 2015 meaning that Member State approvals for the substance end on the original approval expiry date. This is 30 September 2012. The use of existing stocks will be allowed up until 31 March 2014.

Bitertanol, Acetochlor and Chloropicrin are substances for which completeness has been established but which have not been included into Annex 1. In all three cases, the applicants were able to avail of an accelerated procedure for assessment of the active substance.

• Bitertanol was approved but made subject to the following conditions and restrictions as a number of concerns were expressed stemming from the proposed categorisation of the substance as 'reproductive toxicant category 1B identified. Firstly, only uses for fungicide for seed treatment are to be authorised and further confirmatory data is required as data related to the hazard profile of the substance will need to be reassessed. There are three relevant deadlines for the submission of the confirmatory data: the 30 June 2012, the 31 December 2013 and the date that falls two years after the adoption of specific guidance. Additionally, the approval period was limited to three and half years, the shortest possible period to allow the applicant to submit the additional data requested. The date of expiration of approval is thus the 30 June 2015. Member states must, where necessary, amend or withdraw existing authorisations for plant protection products containing Bitertanol by 30 June 2012.

• The reasons cited for the non approval of Acetochlor were that various concerns were identified which included: a potential human exposure above the acceptable daily intake; a potential for human exposure to a specific surface water metabolite, the genotoxicity of which could not be excluded; a high risk of ground water contamination for several metabolites; and a high risk for aquatic organisms and herbivorous birds.

• For Chloropicrin, the concerns included: an unacceptable risk to operators; a high risk to aquatic organisms, birds and mammals; and it was not possible to perform a reliable groundwater exposure assessment nor a reliable surface water and sediment exposure assessment due to missing data concerning among things a specific metabolite.

• The European Commission has decided not to re-register Acetochlor and Chloropicrin. The following phase out schedule is to apply to both substances: member states will have to withdraw approvals by 23 June 2012 and may allow existing stocks to be used for a further year.

Until very recently, the use of plant protection products containing Clethodium has been restricted at EU level to sugar beets. However in February last year, Arysta LifeScience submitted an application for this restriction to be lifted. One year on, this application has proved successful. By a Commission Regulation dated 1 February 2012, the conditions of the authorisation were amended allowing Clethodium to be used as a herbicide on all crops.

Substance
Date of Regulation
Decision taken
 
Prohexadione
 
20 July 2011
 
Substance approved
 
Azoxystrobin
 
20 July 2011
 
Substance approved
 
Azimsulfuron
 
20 July 2011
 
Substance approved
 
Imazalil
 
20 July 2011
 
Substance approved
 
Profoxydim
 
20 July 2011
 
Substance approved
 
Fluroxypyr
 
26 July 2011
 
Substance approved
 
Flufenoxuron
 
22 September 2011
 
Not approved
 
Propargite
 
22 September 2011
 
Not approved
 
8-hydroxyquinoline
 
6 October 2011
 
Substance approved
 
Benalaxyl-M,
Gamma-cyhalothrin, 
Valifenalate
 
11 October 2011
 
Decision to allow MS to extend provisional authorisations granted
 
Asulam
 
19 October 2011
 
Not approved
 
Propanil
 
25 October 2011
 
Not approved
 
Dicamba, Difenoconazole,
Imazaquin
 
31 October 2011
 
Conditions of approval amended
 
2-naphthyloxyacetic acid
 
7 November 2011
 
Not approved
 
Cinidon-ethyl
 
9 November 2011
 
Non-renewal of the approval
 
Prochloraz
 
10 November 2011
 
Substance approved
 
Bitertanol
 
8 December 2011
 
 
Approved subject to conditions
 
Acetochlor
 
21 December 2011
 
 
Not approved
Chloropicrin
 
22 December 2011
 
 
Not approved


Upcoming new decisions:
 
Deadlines for comments on EU draft assessment reports have been set for four more new active ingredients giving member states until 2 April 2012 to comment on the following herbicide : tembotrione; fungicide: ipconazole; insecticide /acaricide: maltodextrin; and insecticide : chlorantraniliprole.