(1)

On 5 March 2014, the Council adopted Regulation (EU) No 208/2014.

(2)

On the basis of a review by the Council, the entry for one person listed in Annex I to Regulation (EU) No 208/2014 should be deleted.

(3)

Annex I to Regulation (EU) No 208/2014 should therefore be amended accordingly,

(1)

The approval of the active substance prosulfuron, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2), expires on 30 June 2017.

(2)

An application for the renewal of the inclusion of prosulfuron in Annex I to Council Directive 91/414/EEC (3) was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (4) within the time period provided for in that Article.

(3)

The applicant submitted the supplementary dossiers required in accordance with Article 9 of Regulation (EU) No 1141/2010. The application was found to be complete by the rapporteur Member State.

(4)

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 (hereinafter ‘the Authority’) and the Commission on 15 July 2013.

(5)

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

(6)

On 25 August 2014 the Authority communicated to the Commission its conclusion (5) on whether prosulfuron can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft review report for prosulfuron to the Standing Committee on Plants, Animals, Food and Feed on 29 May 2015.

(7)

It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance that the approval criteria provided for in Article 4 are satisfied. Those approval criteria are therefore deemed to be satisfied.

(8)

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. It is, in particular, appropriate to restrict the use of plant protection products containing prosulfuron in order to minimise the exposure for groundwater by setting a maximum dose of 20 g of active substance per hectare, every third year on the same field and to require further confirmatory information.

(9)

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

(10)

The Commission however considers that prosulfuron is 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. Prosulfuron therefore fulfils the condition set in the second indent of point 4 of Annex II to Regulation (EC) No 1107/2009.

(11)

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

(12)

In accordance with Article 20(3) of Regulation (EC) No 1107/2009, in conjunction with Article 13(4) thereof, the Annex to Implementing Regulation (EU) No 540/2011 should be amended accordingly.

(13)

Commission Implementing Regulation (EU) 2016/549 (6) extended the expiry date of prosulfuron 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 the extended expiry date, this Regulation should apply from 1 May 2017.

(14)

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

(1)

On 7 August 2014 the government of the Russian Federation (‘Russia’) introduced a ban on imports of certain products from the Union to Russia, including fruit and vegetables. This import ban created a serious threat of market disturbances caused by significant price falls due to the fact that an important export market was no longer available. This import ban is extended until end of 2017. In such circumstances, threats of market disturbances in the Union remain real for certain specific products such as apples and pears and adequate measures need to be adopted and implemented for as long as the Russian ban remains in force.

(2)

The threat of market disturbances is of particular relevance for the fruit and vegetables sector where large quantities of perishable products used to be exported to Russia. It has proved difficult to redirect the entire production to other destinations. Accordingly, a situation continues to exist on the Union market for which the normal measures available under Regulation (EU) No 1308/2013 appear to be insufficient.

(3)

In order to prevent a severe and prolonged market disturbance, Commission Delegated Regulations (EU) No 913/2014 (2), (EU) No 932/2014 (3), (EU) No 1031/2014 (4) (EU) 2015/1369 (5) and (EU) 2016/921 (6) provided for maximum amounts of support for withdrawal, non-harvesting and green harvesting operations, calculated on the basis of traditional exports to Russia.

(4)

Delegated Regulation (EU) 2016/921 also recognised that products covered by the scheme established by that Regulation, which were exported to Russia, could be diverted to the markets of other Member States. Producers of the same products within the Member States which did not traditionally export their products to Russia could therefore face significant market disturbance, in particular a price fall. In order to stabilise the market, Union financial assistance was therefore made available for producers in all Member States in respect of one or more of the products covered by that Regulation, but the quantity of the products concerned was not to exceed 3 000 tonnes per Member State.

(5)

Member States remained free to decide to what extent they would use the quantity of 3 000 tonnes. Where they chose not to use this quantity, they were to notify the Commission of the unused quantity by 31 October 2016.

(6)

By 31 October 2016, Germany, Denmark, Luxembourg, Slovakia, Slovenia, Austria and the United Kingdom formally notified the Commission that they decided not to use their quantities or parts thereof.

(7)

The quantities not used should therefore be reallocated. The reallocation should be based on transparent, objective and fair criteria. This should be best ensured by using as the basis for reallocation the share of each Member State in the total quantity as currently allocated in Annex I to Delegated Regulation (EU) 2016/921. To ensure that the allocation per Member State reaches at least 300 tonnes, for Cyprus, Croatia and Portugal the allocations should be increased from 85 tonnes to 300 tonnes, respectively. This measure is required as reallocation of quantities below 85 tonnes would create an undue administrative burden for national authorities, in particular as regards the checks and at the same time would not significantly affect the situation of the producers and that of the market.

(8)

To ensure immediate impact on the market and to help stabilise prices in the Member States concerned, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union and should apply as from that day until 30 June 2017,

(1)

Article 2 is amended as follows:

(2)

In Article 3, the first paragraph is replaced by the following:

‘Member States shall allocate the quantities referred to in Article 2(1) and (5) between producer organisations and producers who are not members of producer organisations following the first-come, first-served system.’

(3)

Annex V is added, the text of which is set out in the Annex to this Regulation.

(1)

In accordance with Article 80(1)(a) of Regulation (EC) No 1107/2009, Council Directive 91/414/EEC (2) is to apply, with respect to the procedure and the conditions for approval, to active substances for which a decision has been adopted in accordance with Article 6(3) of that Directive before 14 June 2011. For Pseudozyma flocculosa strain ATCC 64874 the conditions of Article 80(1)(a) of Regulation (EC) No 1107/2009 are fulfilled by Commission Decision 2002/305/EC (3).

(2)

In accordance with Article 6(2) of Directive 91/414/EEC the Netherlands (hereinafter ‘the rapporteur Member State’) received on 6 March 2001 an application from Maasmond-Westland for the inclusion of the active substance Pseudozyma flocculosa strain ATCC 64874 in Annex I to Directive 91/414/EEC. Decision 2002/305/EC confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

(3)

For that active substance, the effects on human and animal health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 11 March 2004.

(4)

Artechno SA took over the responsibility of Maasmond-Westland on 4 June 2012 and in accordance with Article 11(6) of Commission Regulation (EU) No 188/2011 (4) additional information was requested from the applicant.

(5)

The draft assessment report was reviewed by the Member States and the European Food Safety Authority (hereinafter ‘the Authority’). The Authority presented to the Commission its conclusion on the pesticide risk assessment of the active substance Pseudozyma flocculosa strain ATCC 64874 (5) on 22 September 2015. The Authority identified several data gaps. In particular, it was not possible to conclude on the risk assessment for human health and aquatic organisms deriving from the use of Pseudozyma flocculosa strain ATCC 64874.

(6)

Consequently, it was not possible to conclude on the basis of the information available that Pseudozyma flocculosa strain ATCC 64874 met the criteria for inclusion in Annex I to Directive 91/414/EEC.

(7)

The Commission invited the applicant to submit its comments on the conclusion of the Authority. Furthermore, in accordance with Article 9 of Regulation (EU) No 188/2011, the Commission invited the applicant to submit comments on the draft review report. The applicant submitted its comments, which have been carefully examined.

(8)

However, despite the arguments put forward by the applicant, the concerns referred to in recital 5 could not be eliminated. Consequently, it has not been demonstrated that it may be expected that, under the proposed conditions of use, plant protection products containing Pseudozyma flocculosa strain ATCC 64874 satisfy in general the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC.

(9)

Pseudozyma flocculosa strain ATCC 64874 should therefore not be approved pursuant to Article 13(2) of Regulation (EC) No 1107/2009.

(10)

In accordance with Article 8(1)(b) of Directive 91/414/EEC, Member States were given the possibility to grant provisional authorisations, for plant protection products containing Pseudozyma flocculosa strain ATCC 64874 for an initial period of three years.

(11)

Existing authorisations should consequently be withdrawn.

(12)

Member States should be provided with time to withdraw authorisations for plant protection products containing Pseudozyma flocculosa strain ATCC 64874.

(13)

For plant protection products containing Pseudozyma flocculosa strain ATCC 64874, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 24 June 2018.

(14)

This Regulation does not prejudice the submission of a further application for Pseudozyma flocculosa strain ATCC 64874 in accordance with Article 7 of Regulation (EC) No 1107/2009.

(15)

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

(1)

Annex I to Regulation (EC) No 1334/2008 lays down a Union list of flavourings and source materials approved for use in and on foods and their conditions of use.

(2)

Commission Implementing Regulation (EU) No 872/2012 (3) adopted a list of flavouring substances and introduced that list in Part A of Annex I to Regulation (EC) No 1334/2008.

(3)

That list may be updated in accordance with the common procedure referred to in Article 3(1) of Regulation (EC) No 1331/2008, either on the initiative of the Commission or following an application submitted by a Member State or by an interested party.

(4)

The Union list of flavourings and source materials contains a number of substances for which the European Food Safety Authority (‘the Authority’) has requested additional scientific data to be provided for completion of the evaluation before the deadlines established in Part A of Annex I to Regulation (EC) No 1334/2008.

(5)

In the case of the substances belonging to the Flavouring Group Evaluation (‘FGE 203’) rev.1: the deadline of 31 December 2012 was established in the Union list for the submission of requested additional scientific data. The substances belonging to this FGE203 rev.1 are: deca-2,4-dien-1-ol (FL No 02.139), hepta-2,4-dien-1-ol (FL No 02.153), hexa-2,4-dien-1-ol (FL No 02.162), nona-2,4-dien-1-ol (FL No 02.188), hexa-2(trans),4(trans)-dienal (FL No 05.057), trideca-2(trans),4(cis),7(cis)-trienal (FL No 05.064), nona-2,4-dienal (FL No 05.071), 2,4-decadienal (FL No 05.081), hepta-2,4-dienal (FL No 05.084), penta-2,4-dienal (FL No 05.101), undeca-2,4-dienal (FL No 05.108), dodeca-2,4-dienal (FL No 05.125), octa-2(trans),4(trans)-dienal (FL No 05.127), deca-2(trans),4(trans)-dienal (FL No 05.140), deca-2,4,7-trienal (FL No 05.141), nona-2,4,6-trienal (FL No 05.173), 2,4-octadienal (FL No 05.186), tr-2,tr-4-nonadienal (FL No 05.194), tr-2,tr-4-undecadienal (FL No 05.196), and hexa-2,4-dienyl acetate (FL No 09.573). Such data has been submitted by the applicant.

(6)

That chemical group includes hexa-2(trans),4(trans)-dienal (FL No 05.057) and deca-2(trans),4(trans)-dienal (FL No 05.140) which were used as representative substances for the group and for which toxicity data were submitted.

(7)

The Authority has evaluated the genotoxicity of these two representative substances in its scientific opinion of 26 March 2014 (4).

(8)

For hexa-2(trans),4(trans)-dienal (FL No 05.057) it confirmed safety concerns based on the evidence from publications reporting the induction of DNA adducts in different systems in vitro and in vivo, the IARC classification as possible carcinogen to humans, considering the conclusion drawn by IARC that mechanistic data provide additional support for the relevance of the animal carcinogenicity data to humans and that there is a moderate evidence that tumour induction occurs via a genotoxic mechanism.

(9)

For deca-2(trans),4(trans)-dienal (FL No 05.140) it came to the conclusion that a non-threshold mechanism of genotoxicity cannot be excluded on the basis that there is some indication for genotoxicity in vivo and considering the evidence from in vitro studies for the induction of different types of DNA damage (oxidised DNA bases and bulky adducts).

(10)

Overall, the Authority concluded that the safety concern regarding genotoxicity cannot be ruled out for both representative substances of the group and that this conclusion is likewise applicable to the other substances of the FGE group 203.

(11)

The parties concerned have indicated that they are undertaking a variety of toxicity studies on the substances in FGE group 203 responding to the concerns expressed by the Authority. In addition, the Commission has requested further information in order to fully evaluate the safety of those substances.

(12)

The supporting parties submitted the studies and information on 26 September 2016.

(13)

Pending the evaluation by the Authority of the substances in group FGE, the eventual full evaluation of these substances according to the EFSA CEF panel procedure and the completion of the subsequent regulatory process, it is appropriate to limit the conditions of use of those substances to their current use.

(14)

Due to technical reasons, transitional periods should be laid down to cover food not complying with the conditions set out in the Annex, which has been placed on the Union market or dispatched from third countries for the Union before the entry into force of this Regulation.

(15)

Part A of Annex I to Regulation (EC) No 1334/2008 should therefore be amended accordingly.

(16)

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

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

(1)

On 15 April 2015, the Council adopted Decision (CFSP) 2015/599 (1) appointing Mr Fernando GENTILINI as the European Union Special Representative (EUSR) for the Middle East Peace Process (MEPP). The EUSR's mandate is to expire on 28 February 2017.

(2)

The EUSR's mandate should be extended for a further period of 16 months.

(3)

The EUSR will implement the mandate in the context of a situation which may deteriorate and could impede the achievement of the objectives of the Union's external action as set out in Article 21 of the Treaty,

(a)

establishing a specific security plan based on guidance from the EEAS, including specific physical, organisational and procedural security measures, governing the management of the secure movement of personnel to, and within, the area of responsibility, as well as management of security incidents and including a contingency and evacuation plan;

(b)

ensuring that all personnel deployed outside the Union are covered by high risk insurance, as required by the conditions in the area of responsibility;

(c)

ensuring that all members of the EUSR's team to be deployed outside the Union, including locally contracted personnel, have received appropriate security training before or upon arriving in the area of responsibility, based on the risk ratings assigned to that area by the EEAS;

(d)

ensuring that all agreed recommendations made following regular security assessments are implemented and providing the Council, the HR and the Commission with written reports on their implementation and on other security issues within the framework of the progress report and the report on the implementation of the mandate.

(1)

On 5 March 2014, the Council adopted Decision 2014/119/CFSP (1).

(2)

On 4 March 2016 the Council extended the restrictive measures against 16 persons until 6 March 2017 (2).

(3)

On the basis of a review of the restrictive measures set out in Decision 2014/119/CFSP, the application of those restrictive measures should be extended until 6 March 2018. The entry for one person listed in the Annex to Decision 2014/119/CFSP should be deleted.

(4)

Decision 2014/119/CFSP should therefore be amended accordingly,

(1)

in Article 5, the second paragraph is replaced by the following:

‘This Decision shall apply until 6 March 2018.’;

(2)

the Annex is amended as set out in in the Annex to this Decision.