8.9.2017   

EN

Official Journal of the European Union

L 232/1

(1)

In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 7 June 2016 an application from the Agriculture and Horticulture Development Board (UK) and the Institut Technique de l'Agriculture Biologique (ITAB) for the approval of salt as a basic substance for use as a fungicide in mushrooms. In addition, the Commission received on 21 July 2016 an application from ITAB for the approval of sea salt as basic substance for use as a fungicide and insecticide in grapes. Since both applications concern the substance sodium chloride of food-grade quality, the applications were merged. The applications were accompanied by the information required by the second subparagraph of Article 23(3) of Regulation (EC) No 1107/2009.

(2)

The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical Report on sodium chloride on 20 January 2017 (2). The Commission presented the review report (3) and a draft of this Regulation to the Standing Committee on Plants, Animals, Food and Feed on 23 March 2017 and finalised them for the meeting of that Committee on 20 July 2017.

(3)

The documentation provided by the applicant shows that sodium chloride fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (4). Moreover, it is not predominantly used for plant protection purposes but nevertheless is useful in plant protection in a product consisting of the substance and water. Consequently, it is to be considered as a basic substance.

(4)

It has appeared from the examinations made that sodium chloride may be expected to satisfy, in general, the requirements laid down in Article 23 of Regulation (EC) No 1107/2009, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to approve sodium chloride as a basic substance.

(5)

In accordance with Article 13(2) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions.

(6)

In accordance with Article 13(4) of Regulation (EC) No 1107/2009, the Annex to Commission Implementing Regulation (EU) No 540/2011 (5) should be amended accordingly.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

8.9.2017   

EN

Official Journal of the European Union

L 232/4

(1)

Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

(2)

In view of the time and resources necessary for completing the assessment of applications for the renewal of approvals of the large number of active substances the approvals of which are expiring between 2019 and 2021, Commission Implementing Decision C/2016/6104 (3) established a work programme grouping together similar active substances and setting priorities on the basis of safety concerns for human and animal health or the environment as provided for in Article 18 of Regulation (EC) No 1107/2009.

(3)

Active substances propaquizafop, quizalofop-p-ethyl and quizalofop-p-tefuryl have approvals which were originally expiring between 2019 and 2021. Considering that the three substances are ester variants of quizalofop, they share similar properties. Taking into account Implementing Decision C/2016/6104, the hazard properties of quizalofop-p-tefuryl (4) and the fact that the three substances have important similarities, it is appropriate to group them together in order to align the timing of their assessment and the peer-review process carried out by the European Food Safety Authority. Consequently, the dossiers for the three substances should be submitted to their respective rapporteur Member States within the same time frame.

(4)

The approvals of propaquizafop and quizalofop-p-ethyl expire on 30 November 2021. In order to align the timing of the assessment of the substance quizalofop-p-tefuryl with the assessment of the other two substances the approval period of the substance quizalofop-p-tefuryl should be extended.

(5)

An application for the renewal of the approval of quizalofop-p-tefuryl was submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (5).

(6)

In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where no supplementary dossier in accordance with Implementing Regulation (EU) No 844/2012 is submitted no later than 30 months before the expiry date laid down in Article 1 of this Regulation, the Commission will set the expiry date at the same date as before this Regulation or at the earliest date thereafter.

(7)

In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission will adopt a Regulation providing that the approval of the active substance referred to in this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission will adopt a Regulation providing for the renewal of the active substance referred to in this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.

(8)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(9)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

8.9.2017   

EN

Official Journal of the European Union

L 232/6

(1)

Commission Directive 2003/23/EC (2) included imazamox as an active substance in Annex I to Council Directive 91/414/EEC (3).

(2)

Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

(3)

The approval of the active substance imazamox, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011 expires on 31 July 2018.

(4)

An application for the renewal of the approval of imazamox was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

(5)

The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

(6)

The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 13 April 2015.

(7)

The Authority communicated the renewal assessment report to the applicant and to the other Member States for comments and forwarded the comments received to the Commission. The Authority also made the supplementary summary dossier available to the public.

(8)

On 15 March 2016 the Authority communicated to the Commission its conclusion (6) on whether imazamox can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft renewal report for imazamox to the Standing Committee on Plants, Animals, Food and Feed on 11 July 2016.

(9)

The applicant was given the opportunity to submit comments on the draft renewal report.

(10)

It has been established with respect to one or more representative uses of at least one plant protection product containing imazamox that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate to renew the approval of imazamox.

(11)

The risk assessment for the renewal of the approval of imazamox is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing imazamox may be authorised. It is therefore appropriate to remove the restriction to use only as a herbicide.

(12)

The Commission, however, considers that imazamox is a candidate for substitution pursuant to Article 24 of Regulation (EC) No 1107/2009. Imazamox 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 and sediment is higher than 120 days and the long term no-observed effect concentration for aquatic plants is 0,0045 mg/l. Imazamox therefore fulfils the condition set in the second indent of point 4 of Annex II to Regulation (EC) No 1107/2009.

(13)

It is therefore appropriate to renew the approval of imazamox as a candidate for substitution.

(14)

In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to include certain conditions and restrictions.

(15)

The Annex to Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

(16)

Commission Implementing Regulation (EU) 2017/841 (7) extended the approval period of imazamox to 31 July 2018 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on renewal has been taken ahead of this extended expiry date, this Regulation should apply from 1 November 2017.

(17)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

8.9.2017   

EN

Official Journal of the European Union

L 232/11

(1)

At the 60th meeting of representatives of Members States Competent Authorities for the implementation of Regulation (EU) No 528/2012 held on 20 and 21 May 2015, all Member States submitted to the Commission a number of questions to be addressed at Union level in the context of the comparative assessment to be carried out at the renewal of anticoagulant rodenticide biocidal products (‘anticoagulant rodenticides’).

(2)

The questions submitted were the following: (a) Is the chemical diversity of the active substances in authorised rodenticides in the Union adequate to minimise the occurrence of resistance in the target harmful organisms?; (b) For the different uses specified in the applications for renewal, are alternative authorised biocidal products or non-chemical means of control and prevention methods available?; (c) Do these alternatives present a significantly lower overall risk for human health, animal health and the environment?; d) Are these alternatives sufficiently effective?; (e) Do these alternatives present no other significant economic or practical disadvantages?

(3)

The answers to these questions are relevant for any receiving competent authority for the purpose of deciding whether the criteria in Article 23(3)(a) and (b) of Regulation (EU) No 528/2012 are met and, as a consequence, whether it shall prohibit or restrict the making available on the market or the use of anticoagulant rodenticides.

(4)

Pursuant to Article 75(1)(g) of Regulation (EU) No 528/2012, the Commission requested from the European Chemicals Agency (‘Agency’) to formulate an opinion addressing the questions for the different uses that may be authorised in anticoagulant rodenticides according to the conditions and risk mitigation measures referred to in the opinions (2) adopted by the Biocidal Products Committee of the Agency at its 16th meeting for the renewal of the active substance approvals.

(5)

On 2 March 2017, the Biocidal Products Committee of the Agency adopted its opinion (3).

(6)

According to that opinion, in the absence of anticoagulant rodenticides, the use of rodenticide biocidal products containing other active substances would lead to an inadequate chemical diversity to minimize the occurrence of resistance in the target harmful organisms. These products also showed some significant practical or economical disadvantages for the relevant uses.

(7)

The opinion also considered a number of non-chemical control or prevention methods (‘non-chemical alternatives’), which may provide sufficient efficacy in certain circumstances on their own or in a combination of them. However, there is insufficient scientific evidence to prove that those non-chemical alternatives are sufficiently effective according to the criteria established in agreed Union guidance (4) with a view to prohibit or restrict the authorised uses of anticoagulant rodenticides.

(8)

Nevertheless the Commission notes the recommendation in the opinion that the use of non-chemical alternatives is a fundamental part of sustainable pest management for rodent control and proper use of anticoagulant rodenticides in accordance with Article 17(5) of Regulation (EU) No 528/2012.

(9)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,