title: Commission Implementing Regulation (EU) 2018/1048 of 18 July 2018 laying down airspace usage requirements and operating procedures concerning performance-based navigation

text:
                  26.7.2018

                  EN

                  Official Journal of the European Union

                  L 189/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1048
         of 18 July 2018
         laying down airspace usage requirements and operating procedures concerning performance-based navigation
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (1), and in particular Article 8b(6) thereof,
         Whereas:

                     (1)

                     The continued growth of aviation is placing increasing demands on the use of available airspace, thus heightening the need to use it as effectively and efficiently as possible. The provision of air traffic management/air navigation services (ATM/ANS) using performance-based navigation (PBN) can bring safety, capacity and efficiency benefits through the optimisation of air traffic service routes and instrument approach procedures. In order to achieve those benefits and improve the performance of the European air traffic management network, harmonised airspace usage requirements and operating procedures concerning PBN should be provided for.

                     (2)

                     Those requirements and procedures concerning PBN should be based on the rules developed by the International Civil Aviation Organisation (ICAO) and their implementation should be in accordance with the ICAO Global Air Navigation Plan (2) and the European ATM Master Plan (3).

                     (3)

                     The Annex to Commission Implementing Regulation (EU) No 923/2012 (4) and in particular point SERA.5015(a) thereof, Annex III to Commission Regulation (EU) No 965/2012 (5) and in particular point ORO.GEN.110(d) thereof, Article 9(1) of Regulation (EC) No 216/2008, as implemented by Annex I to Commission Regulation (EU) No 452/2014 (6), and in particular point TCO.205 thereof, require that aircraft be equipped and flight crew be suitably qualified to operate on the intended route or procedure. Those requirements should be complemented by common airspace usage requirements specifying the corresponding flight procedures and routes.

                     (4)

                     The implementation of PBN in high-density terminal manoeuvring areas, as required by Commission Implementing Regulation (EU) No 716/2014 (7), is expected to improve the precision of approach trajectory and facilitate traffic sequencing at an earlier stage, so that fuel consumption and environmental impact in descent and arrival phases can be reduced. In order to facilitate implementation, the requirements of this Regulation should be consistent with those of Implementing Regulation (EU) No 716/2014.

                     (5)

                     The use of satellite-based augmentation systems (SBASs), in particular in the form of the European Geostationary Navigation Overlay Service (EGNOS), should be promoted, as safety and cost-efficiency considerations support the establishment of localiser performance with vertical guidance (LPV) minima approaches. However, operations with other PBN capabilities should be facilitated by providing for other minima in addition to LPV.

                     (6)

                     When developing the European Route Network Improvement Plan, the Network Manager referred to in Commission Regulation (EU) No 677/2011 (8) is, pursuant to that Regulation, to rely on a cooperative decision-making process. Accordingly, in relation to the provision of ATM/ANS in accordance with this Regulation, the Network Manager should coordinate with the providers of ATM/ANS, in particular in order to ensure that ATS routes used for the purpose of transitioning to or from the en route network are consistent with the specification of the standard instrument departure (SID) routes and standard instrument arrival (STAR) routes served.

                     (7)

                     The requirements for providers of ATM/ANS concerning the implementation of PBN set out in this Regulation should include, in particular, appropriate requirements for the implementation at all instrument runway ends of 3D approach procedures and, where those providers have established SID routes or STAR routes, the implementation of those routes. However, imposing those requirements could in certain situations have serious adverse consequences which outweigh the potential safety, capacity and efficiency benefits. Therefore, providers of ATM/ANS should in those situations be entitled to deviate from those requirements and instead be made subject to certain alternative requirements which are better suited for those specific situations, while still achieving those benefits as much as possible.

                     (8)

                     Furthermore, in the interest of a safe and smooth transition, providers of ATM/ANS should be allowed to provide their services also through other means than using PBN in accordance with the requirements of this Regulation for a reasonable time period. However, they should no longer be allowed to do so, other than by means of contingency measures, from 1 June 2030, in light of the need to rationalise ATM/ANS provision and avoid unnecessary costs, in particular to airspace users, resulting from the existence of multiple layers of navigation infrastructure.

                     (9)

                     In the interest of safety, a smooth and coordinated transition should be ensured to the provision of ATM/ANS using performance-based navigation in accordance with the requirements of this Regulation. Providers of ATM/ANS should therefore take, in a timely and effective manner, all necessary measures to that aim. Those measures should include the establishment of a transition plan, which each provider should keep up-to-date so as to take account of all relevant developments relating to the transition. Those transition plans, and any updates thereof which are significant in that they entail substantial changes to the plans and are capable of materially affecting the interests of interested parties, should be established after a process of consultation of interested parties, in order to ensure that their views are taken into account where appropriate, and after approval by the competent authority, in order to ensure compliance with the requirements set out in this Regulation and in particular Article 4(1).

                     (10)

                     Exceptionally, situations may arise where, after the implementation of the PBN requirements laid down in this Regulation, it proves impossible for providers of ATM/ANS, for unexpected reasons beyond their control, to provide their services in accordance with those requirements. Without prejudice to the obligation on those providers to take all reasonable measures lying within their control to prevent such situations from arising and to restore compliance with those requirements as soon as possible when such situations nonetheless arises, they should therefore be required to take the necessary contingency measures for the continued, safe provision of their services through other means, in particular by using conventional navigation procedures.

                     (11)

                     It is necessary to allow sufficient time for the parties concerned to comply with this Regulation. The requirement regarding the exclusive use of PBN should apply from an appropriate later date, so as to allow for sufficient time for a safe and smooth transition. In addition, certain provisions of the Annex should also apply from an appropriate later date, in light of the additional time needed for the parties concerned to adapt to the requirements in question.

                     (12)

                     The measures provided for in this Regulation are based on the opinion issued by the European Aviation Safety Agency in accordance with point (b) of Article 17(2) and Article 19(1) of Regulation (EC) No 216/2008.

                     (13)

                     The measures provided in this Regulation are in accordance with the opinion of the Committee established by Article 5 of Regulation (EC) No 549/2004 of the European Parliament and of the Council (9),

               HAS ADOPTED THIS REGULATION:

            Article 1
            Subject matter and scope

               1.   This Regulation lays down airspace usage requirements and operating procedures concerning performance-based navigation.

               2.   This Regulation applies to providers of air traffic management/air navigation services (ATM/ANS), and operators of aerodromes (hereinafter ‘providers of ATM/ANS’) that are responsible for putting in place instrument approach procedures or air traffic service (ATS) routes, where they provide their services in the following airspace:

                           (a)

                           above the territory to which the Treaty applies;

                           (b)

                           any other airspace where Member States are responsible for the provision of air navigation services in accordance with Article 1(3) of Regulation (EC) No 551/2004 of the European Parliament and of the Council (10).

            Article 2
            Definitions
            For the purposes of this Regulation, the following definitions shall apply:

                        (1)

                        ‘performance based navigation (PBN)’ means performance based navigation as defined in Article 2(5) of Regulation (EU) No 965/2012;

                        (2)

                        ‘ATS route’ means ATS route as defined in Article 2(46) of Implementing Regulation (EU) No 923/2012;

                        (3)

                        ‘instrument approach procedure’ means instrument approach procedure as defined in Article 2(90) of Implementing Regulation (EU) No 923/2012;

                        (4)

                        ‘conventional navigation procedures’ means ATS routes and instrument approach procedures predicated on the use of ground-based navigation aids that do not enable compliance with the PBN requirements set out in this Regulation;

                        (5)

                        ‘instrument runway’ means instrument runway as defined in Annex I, point 22 of Commission Regulation (EU) No 139/2014 (11);

                        (6)

                        ‘navigation specification’ means a set of requirements for aircraft and aircrew needed to support performance-based navigation operations within a defined airspace;

                        (7)

                        ‘required navigation performance (RNP) X specification’ means a navigation specification based on area navigation that includes the requirement for on-board performance monitoring and alerting, whereby ‘X’ refers to the lateral navigation accuracy in nautical miles or the operation type and required functionalities;

                        (8)

                        ‘lateral navigation (LNAV)’, ‘lateral navigation/vertical navigation (LNAV/VNAV)’ and ‘localizer performance with vertical guidance (LPV)’ mean the labels to identify the different types of operating minima on approach charts depicting approach procedures based on Global Navigation Satellite Systems (GNSS) which are classified as RNP approaches (RNP APCH);

                        (9)

                        ‘radius to fix (RF)’ means a constant radius circular path about a defined turn centre that terminates at a fixed point;

                        (10)

                        ‘2D approach’ means an instrument approach procedure, classified as an non-precision approach procedure, as defined in Article 2(90) of Implementing Regulation (EU) No 923/2012;

                        (11)

                        ‘3D approach’ means an instrument approach procedure, classified as an approach with vertical guidance or a precision approach, as defined in Article 2(90) of Implementing Regulation (EU) No 923/2012;

                        (12)

                        ‘satellite-based augmentation system (SBAS)’ means a wide-coverage augmentation system in which the user of a GNSS receives augmentation information from a satellite-based transmitter;

                        (13)

                        ‘area navigation (RNAV) X specification’ means a navigation specification based on area navigation that does not include the requirement for on-board performance monitoring and alerting, whereby ‘X’ refers to the lateral navigation accuracy in nautical miles;

                        (14)

                        ‘standard instrument arrival (STAR) route’ means a designated instrument flight rule arrival route linking a significant point, normally on an air traffic service (ATS) route, with a point at which a published instrument approach procedure can be commenced;

                        (15)

                        ‘standard instrument departure (SID) route’ means a designated instrument flight rule departure route linking the aerodrome with a specified significant point, normally on a designated ATS route, at which the en route phase of a flight commences;

                        (16)

                        ‘navigation functionality’ means the detailed capability of the navigation system required to meet the needs of the proposed operations in the airspace.

            Article 3
            PBN requirements
            Providers of ATM/ANS shall comply with the requirements for the implementation of performance-based navigation set out in Subpart PBN of the Annex.

            Article 4
            Transitional measures

               1.   Providers of ATM/ANS shall take the necessary measures to ensure a smooth and safe transition to the provision of their services using performance-based navigation in accordance with Article 3.
               Those measures shall include the establishment and implementation of a transition plan. Providers of ATM/ANS shall keep their transition plan up-to-date.
               The transition plan shall be consistent with the European ATM Master Plan and the common projects referred to in Article 15a of Regulation (EC) No 550/2004 of the European Parliament and of the Council (12).

               2.   Providers of ATM/ANS shall consult all of the following parties on the draft transition plan and the draft of any significant updates thereof and take account of their views where appropriate:

                           (a)

                           aerodrome operators, airspace users and representative organisations of such airspace users affected by the provision of their services;

                           (b)

                           the Network Manager referred to in Article 3(1) of Regulation (EU) No 677/2011;

                           (c)

                           providers of ATM/ANS that provide their services in adjacent airspace blocks.

               3.   After having carried out the consultation referred to in paragraph 2, providers of ATM/ANS shall submit the results of the consultation, as well as the draft transition plan, or the draft significant update thereof, for approval to the competent authority responsible for the airspace concerned.
               That competent authority shall verify whether the draft transition plan, or the draft significant update thereof, complies with the requirements of this Regulation and in particular whether it takes account of the views of airspace users where appropriate, including those operating State aircraft. Member State of the competent authority may provide that such verification shall be carried out in coordination with other relevant authorities of the Member State concerned.
               That competent authority shall inform the providers of ATM/ANS of the outcome of that verification without undue delay. Providers of ATM/ANS shall not establish or implement the transition plan, or the significant update thereof, before having been informed by that competent authority that it has approved the draft transition plan or draft significant update thereof.

            Article 5
            Exclusive use of PBN

               1.   Providers of ATM/ANS shall not provide their services using conventional navigation procedures, or using performance-based navigation which is not in accordance with the requirements of point AUR.PBN.2005 of the Annex.

               2.   Paragraph 1 shall be without prejudice to Article 6 and to the possibility of providers of ATM/ANS to provide their services using landing systems enabling CAT II, CAT IIIA or CAT IIIB operations within the meaning of points 14, 15 and 16, respectively, of Annex I to Regulation (EU) No 965/2012.

            Article 6
            Contingency measures
            Providers of ATM/ANS shall take the necessary measures to ensure that they remain capable of providing their services through other means where, for unexpected reasons beyond their control, GNSS or other methods used for performance-based navigation are no longer available, making it impossible for them to provide their services in accordance with Article 3. Those measures shall include, in particular, retaining a network of conventional navigation aids and related surveillance and communications infrastructure.

            Article 7
            Entry into force and application

               1.   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

               2.   This Regulation shall apply from 3 December 2020.
               However, by way of derogation from the first subparagraph:

                           (a)

                           Article 5 shall apply from 6 June 2030;

                           (b)

                           for aerodromes listed in point 1.2.1 of the Annex to Implementing Regulation (EU) No 716/2014 and for instrument runway ends served by precision approach procedures at other aerodromes, point AUR.PBN.2005(1) of the Annex shall apply from 25 January 2024;

                           (c)

                           for all instrument runway ends, point AUR.PBN.2005(4) of the Annex shall apply from 25 January 2024 with respect to one SID or STAR route established and from 6 June 2030 with respect to all SID or STAR routes established;

                           (d)

                           for ATS routes below FL 150, point AUR.PBN.2005(6) of the Annex shall apply from 25 January 2024.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 18 July 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 79, 13.3.2008, p. 1.

            (2)  ICAO Doc 9750.

            (3)  Commission Implementing Regulation (EU) No 409/2013 of 3 May 2013 on the definition of common projects, the establishment of governance and the identification of incentives supporting the implementation of the European Air Traffic Management Master Plan (OJ L 123, 4.5.2013, p. 1).

            (4)  Commission Implementing Regulation (EU) No 923/2012 of 26 September 2012 laying down the common rules of the air and operational provisions regarding services and procedures in air navigation and amending Implementing Regulation (EU) No 1035/2011 and Regulations (EC) No 1265/2007, (EC) No 1794/2006, (EC) No 730/2006, (EC) No 1033/2006 and (EU) No 255/2010 (OJ L 281, 13.10.2012, p. 1).

            (5)  Commission Regulation (EU) No 965/2012 of 5 October 2012 laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 296, 25.10.2012, p. 1).

            (6)  Commission Regulation (EU) No 452/2014 of 29 April 2014 laying down technical requirements and administrative procedures related to air operations of third country operators pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 133, 6.5.2014, p. 12).

            (7)  Commission Implementing Regulation (EU) No 716/2014 of 27 June 2014 on the establishment of the Pilot Common Project supporting the implementation of the European Air Traffic Management Master Plan (OJ L 190, 28.6.2014, p. 19).

            (8)  Commission Regulation (EU) No 677/2011 of 7 July 2011 laying down detailed rules for the implementation of air traffic management (ATM) network functions and amending Regulation (EU) No 691/2010 (OJ L 185, 15.7.2011, p. 1).

            (9)  Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (the framework Regulation) (OJ L 96, 31.3.2004, p. 1).

            (10)  Regulation (EC) No 551/2004 of the European Parliament and of the Council of 10 March 2004 on the organisation and use of the airspace in the single European sky (the airspace Regulation) (OJ L 96, 31.3.2004, p. 20).

            (11)  Commission Regulation (EU) No 139/2014 of 12 February 2014 laying down requirements and administrative procedures related to aerodromes pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 44, 14.2.2014, p. 1).

            (12)  Regulation (EC) No 550/2004 of the European Parliament and of the Council of 10 March 2004 on the provision of air navigation services in the single European sky (the service provision Regulation) (OJ L 96, 31.3.2004, p. 10).

            ANNEX

               SUBPART PBN — Performance-based navigation

               AUR.PBN.1005   Subject-matter

            In accordance with Article 3, this Subpart sets out the requirements for the implementation of performance-based navigation (PBN) to be complied with by providers of ATM/ANS.

               AUR.PBN.2005   Routes and procedures

                        (1)

                        Providers of ATM/ANS shall implement, at all instrument runway ends, approach procedures in accordance with the requirements of the RNP approach (RNP APCH) specification, including LNAV, LNAV/VNAV and LPV minima and, where required due to traffic density or traffic complexity, radius to fix (RF) legs.

                        (2)

                        By way of derogation from point (1), at instrument runway ends where, due to terrain, obstacles or air traffic separation conditions, the implementation of 3D approach procedures is excessively difficult, providers of ATM/ANS shall implement 2D approach procedures in accordance with the requirements of the RNP approach (RNP APCH) specification. In that case, they may also, in addition to the implementation of those 2D approach procedures, implement 3D approach procedures in accordance with the requirements of the RNP authorisation required (RNP AR APCH) specification.

                        (3)

                        By way of derogation from point (1) at instrument runway ends without an appropriate SBAS coverage, providers of ATM/ANS shall implement RNP APCH procedures, including LNAV and LNAV/VNAV minima. Providers of ATM/ANS shall also implement LPV minima at those instrument runway ends, no later than 18 months from the date at which such appropriate SBAS coverage is available.

                        (4)

                        Where providers of ATM/ANS have established SID routes or STAR routes, they shall implement those routes in accordance with the requirements of RNAV 1 specification.

                        (5)

                        By way of derogation from point (4), where providers of ATM/ANS have established SID routes or STAR routes and where higher performance requirements than those referred to in that point are required in order to maintain air traffic capacity and safety in environments with high traffic density, traffic complexity or terrain features, they shall implement those routes in accordance with the requirements of the RNP 1 specification, including one or more of the following additional navigation functionalities:

                                    (a)

                                    operations along a vertical path and between two fixes and with the use of:

                                                (i)

                                                an ‘AT’ altitude constraint;

                                                (ii)

                                                an ‘AT OR ABOVE’ altitude constraint;

                                                (iii)

                                                an ‘AT OR BELOW’ altitude constraint;

                                                (iv)

                                                a ‘WINDOW’ constraint;

                                    (b)

                                    the radius to fix (RF) leg.

                        (6)

                        Where providers of ATM/ANS have established ATS routes for en route operations, they shall implement those routes in accordance with the requirements of the RNAV 5 specification.

                        (7)

                        By way of derogation from points (4) and (6), where providers of ATM/ANS have established ATS routes, SID routes or STAR routes for rotorcraft operations, they shall implement those routes in accordance with the requirements of the RNP 0.3, RNAV 1 or RNP 1 specifications. In that case, they shall be entitled to decide which of those three sets of requirements they comply with.


title: Commission Implementing Regulation (EU) 2018/1077 of 30 July 2018 amending Implementing Regulation (EU) No 808/2014 laying down rules for the application of Regulation (EU) No 1305/2013 of the European Parliament and of the Council on support for rural development by the European Agricultural Fund for Rural Development (EAFRD)

text:
                  31.7.2018

                  EN

                  Official Journal of the European Union

                  L 194/44

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1077
         of 30 July 2018
         amending Implementing Regulation (EU) No 808/2014 laying down rules for the application of Regulation (EU) No 1305/2013 of the European Parliament and of the Council on support for rural development by the European Agricultural Fund for Rural Development (EAFRD)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1305/2013 of the European Parliament and of the Council of 17 December 2013 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) and repealing Council Regulation (EC) No 1698/2005 (1), and in particular Article 8(3) thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) No 808/2014 (2) has laid down rules for the application of Regulation (EU) No 1305/2013. Regulation (EU) 2017/2393 of the European Parliament and of the Council (3) has amended Regulation (EU) No 1305/2013 by simplifying the general rules governing the European Agricultural Fund for Rural Development (EAFRD). Therefore, the rules for the implementation of Regulation (EU) No 1305/2013 should be amended accordingly.

                     (2)

                     The obligation to select bodies to provide advice through a specific call for tenders procedure was abolished. Therefore, implementing rules referring to the calls for tenders should be deleted.

                     (3)

                     Rules for joint setting up of young farmers have been introduced in Article 2(1)(n) of Regulation (EU) No 1305/2013 and a definition of the ‘date of setting up’ has been added in Article 2(1)(s) of that Regulation. Therefore, provisions referring to the young farmer set out in paragraph 8 of Part 1 of Annex I to Implementing Regulation (EU) No 808/2014 should be aligned. Moreover, following the deletion of Article 57 of Commission Implementing Regulation (EU) No 809/2014 (4) containing rules on Farm and business development, the rules for business plan laid down in Implementing Regulation (EU) No 808/2014 should also be simplified.

                     (4)

                     The rules on financial instruments have been simplified. Notably, a derogation from the applicability of selection criteria for operations supported through financial instruments has been introduced in Article 49(4) of Regulation (EU) No 1305/2013. Paragraph 8 of Part 1 of Annex I to Implementing Regulation (EU) No 808/2014 should be aligned with this derogation.

                     (5)

                     In order to avoid unnecessary administrative burden and in particular frequent modifications of the financing plans, it is necessary to clarify that the capping related to the overrun of the planned EAFRD contributions as presented in the financial plan of each programme is calculated at the level of the total amount of each measure.

                     (6)

                     Article 39a of Regulation (EU) No 1305/2013 provides for support to farmers through a sector specific income stabilisation tool and Article 37 of that Regulation allows for support to agricultural insurance schemes covering production losses exceeding 20 % of an annual average caused by adverse climatic events, animal or plant diseases, pest infestation, or an environmental incident. In accordance with Article 8(1)(h) of Regulation (EU) No 1305/2013, the financing plan should indicate the planned EAFRD support and the contribution rate.

                     (7)

                     Implementing Regulation (EU) No 808/2014 should therefore be amended accordingly.

                     (8)

                     The measures provided for in this Regulation are in accordance with the opinion of the Rural Development Committee,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Implementing Regulation (EU) No 808/2014 is amended as follows:

                        (1)

                        Article 7 is deleted;

                        (2)

                        in Article 8, paragraph 1 is deleted;

                        (3)

                        Part 1 of Annex I is amended as follows:

                                    (a)

                                    paragraph 8 ‘Description of the measures selected’ is amended as follows:

                                                (i)

                                                in point (2), point (c) is replaced by the following:

                                                            ‘(c)

                                                            scope, level of support, eligible beneficiaries, and where relevant, methodology for calculation of the amount or support rate broken down by sub-measure and/or type of operation where necessary. For each type of operation specification of eligible costs, eligibility conditions, applicable amounts and support rates and principles with regard to the setting of selection criteria. Where support is provided to a financial instrument implemented under points (a) and (b) of the first subparagraph of Article 38(4) of Regulation (EU) No 1303/2013, description of the type of financial instrument, general categories of final recipients, general categories of eligible costs and maximum level of support.’;

                                                (ii)

                                                in point (2)(e), point 5 is replaced by the following:
                                                ‘5.   Farm and business development (Article 19 of Regulation (EU) No 1305/2013)

                                                            —

                                                            definition of small farm referred to in Article 19(1)(a)(iii) of Regulation (EU) No 1305/2013;

                                                            —

                                                            definition of the actions referred to in point (s) of Article 2(1) of Regulation (EU) No 1305/2013 (“date of setting up”);

                                                            —

                                                            definition of upper and lower thresholds as referred to in the fifth subparagraph of Article 19(4) of Regulation (EU) No 1305/2013;

                                                            —

                                                            specific conditions for support for young farmers where they are not setting up as a sole head of the holding in accordance with Article 2(1) and (2) of Delegated Regulation (EU) No 807/2014;

                                                            —

                                                            information on the application of the grace period referred to in Article 2(3) of Delegated Regulation (EU) No 807/2014;

                                                            —

                                                            summary of the requirements of the business plan;

                                                            —

                                                            use of the possibility to combine different measures through the business plan giving access of the young farmer to those measures;

                                                            —

                                                            domains of diversification covered.’;

                                                (iii)

                                                in point (2)(e), the title of point 16 is replaced by the following:
                                                ‘16.
                                                      Risk management (Articles 36 to 39a of Regulation (EU) No 1305/2013)’;

                                    (b)

                                    paragraph 10(c) is amended as follows:

                                                (i)

                                                in the first subparagraph, the following point (v) is added:

                                                            ‘(v)

                                                            for the operations implemented in accordance with Article 37 of Regulation (EU) No 1305/2013 where the minimum loss threshold is set to 20 % and for operations implemented in accordance with 39a of Regulation (EU) No 1305/2013 the indicative total Union contribution and the indicative contribution rate.’;

                                                (ii)

                                                the following subparagraph is added:
                                                ‘For the purpose of interim payments referred to in Article 36 of Regulation (EU) No 1306/2013, the payment of the balance referred to in Article 37, and the clearance of accounts referred to in Article 51 of that Regulation, the EAFRD contribution to be paid in respect of the eligible public expenditure of the programme concerned shall be respected at the measure level.’

            Article 2
            This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 30 July 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 347, 20.12.2013, p. 487.

            (2)  Commission Implementing Regulation (EU) No 808/2014 of 17 July 2014 laying down rules for the application of Regulation (EU) No 1305/2013 of the European Parliament and of the Council on support for rural development by the European Agricultural Fund for Rural Development (EAFRD) (OJ L 227, 31.7.2014, p. 18).

            (3)  Regulation (EU) 2017/2393 of the European Parliament and of the Council of 13 December 2017 amending Regulations (EU) No 1305/2013 on support for rural development by the European Agricultural Fund for Rural Development (EAFRD), (EU) No 1306/2013 on the financing, management and monitoring of the common agricultural policy, (EU) No 1307/2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy, (EU) No 1308/2013 establishing a common organisation of the markets in agricultural products and (EU) No 652/2014 laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material (OJ L 350, 29.12.2017, p. 15).

            (4)  Commission Implementing Regulation (EU) No 809/2014 of 17 July 2014 laying down rules for the application of Regulation (EU) No 1306/2013 of the European Parliament and of the Council with regard to the integrated administration and control system, rural development measures and cross compliance (OJ L 227, 31.7.2014, p. 69).


title: Commission Implementing Regulation (EU) 2018/1201 of 22 August 2018 entering a name in the register of traditional specialities guaranteed ‘Kiełbasa krakowska sucha staropolska’ (TSG)

text:
                  27.8.2018

                  EN

                  Official Journal of the European Union

                  L 217/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1201
         of 22 August 2018
         entering a name in the register of traditional specialities guaranteed ‘Kiełbasa krakowska sucha staropolska’ (TSG)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 50(2)(b) of Regulation (EU) No 1151/2012, Poland's application to register the name ‘Kiełbasa krakowska sucha staropolska’ was published in the Official Journal of the European Union (2).

                     (2)

                     As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Kiełbasa krakowska sucha staropolska’ should therefore be entered in the register,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The name ‘Kiełbasa krakowska sucha staropolska’ (TSG) is hereby entered in the register.
            The name specified in the first paragraph denotes a product in Class 1.2. – Meat products (cooked, salted, smoked, etc.), as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 22 August 2018.

                  For the Commission,

                  On behalf of the President,

               Pierre MOSCOVICI

                  Member of the Commission

            (1)  OJ L 343, 14.12.2012, p. 1.

            (2)  OJ C 53, 13.2.2018, p. 11.

            (3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).


title: Commission Implementing Regulation (EU) 2018/1264 of 20 September 2018 renewing the approval of the active substance pethoxamid in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance.)

text:
                  21.9.2018

                  EN

                  Official Journal of the European Union

                  L 238/71

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1264
         of 20 September 2018
         renewing the approval of the active substance pethoxamid in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1) and in particular Article 20(1) thereof,
         Whereas:

                     (1)

                     Commission Directive 2006/41/EC (2) included pethoxamid 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 pethoxamid, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 January 2019.

                     (4)

                     An application for the renewal of the approval of pethoxamid 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 31 August 2016.

                     (7)

                     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.

                     (8)

                     On 30 August 2017 the Authority communicated to the Commission its conclusion (6) on whether pethoxamid 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 pethoxamid to the Standing Committee on Plants, Animals, Food and Feed on 6 October 2017.

                     (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 the active substance pethoxamid that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

                     (11)

                     It is therefore appropriate to renew the approval of pethoxamid.

                     (12)

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

                     (13)

                     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 require further confirmatory information.

                     (14)

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

                     (15)

                     Commission Implementing Regulation (EU) 2018/84 (7) extended the expiry date of pethoxamid to 31 January 2019 in order to allow the renewal process to be completed before the expiry of the approval of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation should apply from 1 December 2018.

                     (16)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Renewal of the approval of the active substance
            The approval of the active substance pethoxamid is renewed as set out in Annex I.

            Article 2
            Amendments to Implementing Regulation (EU) No 540/2011
            The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

            Article 3
            Entry into force and date of application
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            It shall apply from 1 December 2018.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 20 September 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 309, 24.11.2009, p. 1.

            (2)  Commission Directive 2006/41/EC of 7 July 2006 amending Council Directive 91/414/EEC to include clothianidin and pethoxamid as active substances (OJ L 187, 8.7.2006, p. 24).

            (3)  Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (OJ L 230, 19.8.1991, p. 1).

            (4)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

            (5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

            (6)  EFSA Journal 2017;15(9):4981 [22 pp.] Available online: www.efsa.europa.eu.

            (7)  Commission Implementing Regulation (EU) 2018/84 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances chlorpyrifos, chlorpyrifos-methyl, clothianidin, copper compounds, dimoxystrobin, mancozeb, mecoprop-p, metiram, oxamyl, pethoxamid, propiconazole, propineb, propyzamide, pyraclostrobin and zoxamide (OJ L 16, 20.1.2018, p. 8).

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                        Pethoxamid
                        CAS No 106700-29-2
                        CIPAC No 665

                        2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide

                        ≥ 940 g/kg
                        Impurities:
                        Toluene: max 3 g/kg.

                        1 December 2018

                        30 November 2033

                        PART A
                        Use shall be limited to one application every two years in the same field at a maximum dose of 1 200  g active substance per hectare.
                        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 renewal report on pethoxamid, and in particular Appendices I and II thereto, shall be taken into account.
                        In their overall assessment Member States shall pay particular attention to:

                                    —

                                    the risk of groundwater metabolites when pethoxamid is applied in regions with vulnerable soil and/or climatic conditions;

                                    —

                                    the risk to aquatic organisms and earthworms;

                                    —

                                    the risk to consumers from residues in the succeeding crops or in case of crop failure.

                              Conditions of use shall include risk mitigation measures, where appropriate.
                        The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

                                    1.

                                    the relevance of the metabolites that may occur in groundwater, taking into account any relevant classification for pethoxamid in accordance with Regulation (EC) No 1272/2008 of the Parliament and of the Council (2), in particular as carcinogen category 2;

                                    2.

                                    the effect of water treatment processes on the nature of residues present in drinking water;

                                    3.

                                    the endocrine disrupting potential of pethoxamid as regards the thyroid modality/pathway as a minimum providing mechanistic data to clarify whether there is a thyroid endocrine disrupting mode of action.

                              The applicant shall submit the information requested under point 1 within one year after the publication of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) Regulation (EC) No 1272/2008 of the European Parliament and of the Council with respect to pethoxamid and the information requested.
                        The applicant shall submit the information requested under point 2 within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.
                        The applicant shall submit the information requested under point 3 by 10 November 2020 in accordance with Commission Regulation (EU) 2018/605 (3) amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties and the joint guidance document to identify endocrine disrupting substances as adopted by EFSA and ECHA.

               (1)  Further details on identity and specification of active substance are provided in the renewal report.

               (2)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

               (3)  Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33).

            ANNEX II
            The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                        (1)

                        in Part A, entry 122 on pethoxamid is deleted;

                        (2)

                        in Part B, the following entry is added:

                                    No

                                    Common Name, Identification Numbers

                                    IUPAC Name

                                    Purity (1)

                                    Date of approval

                                    Expiration of approval

                                    Specific provisions

                                    ‘127

                                    Pethoxamid
                                    CAS No 106700-29-2
                                    CIPAC No 665

                                    2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1-enyl) acetamide

                                    ≥ 940 g/kg
                                    Impurities:
                                    Toluene: max 3 g/kg.

                                    1 December 2018

                                    30 November 2033

                                    PART A
                                    Use shall be limited to one application every two years in the same field at a maximum dose of 1 200  g active substance per hectare.
                                    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 renewal report on pethoxamid, and in particular Appendices I and II thereto, shall be taken into account.
                                    In their overall assessment Member States shall pay particular attention to:

                                                —

                                                the risk of groundwater metabolites when pethoxamid is applied in regions with vulnerable soil and/or climatic conditions;

                                                —

                                                the risk to aquatic organisms and earthworms;

                                                —

                                                the risk to consumers from residues in the succeeding crops or in case of crop failure.

                                          Conditions of use shall include risk mitigation measures, where appropriate.
                                    The applicant shall submit to the Commission, the Member States and the Authority confirmatory information as regards:

                                                1.

                                                the relevance of the metabolites that may occur in groundwater, taking into account any relevant classification for pethoxamid in accordance with Regulation (EC) No 1272/2008 of the Parliament and of the Council (2), in particular as carcinogen category 2;

                                                2.

                                                the effect of water treatment processes on the nature of residues present in drinking water;

                                                3.

                                                the endocrine disrupting potential of pethoxamid as regards the thyroid modality/pathway as a minimum providing mechanistic data to clarify whether there is a thyroid endocrine disrupting mode of action.

                                          The applicant shall submit the information requested under point 1 within one year after the publication of the opinion adopted by the Committee for Risk Assessment of the European Chemicals Agency in accordance with Article 37(4) Regulation (EC) No 1272/2008 of the European Parliament and of the Council with respect to pethoxamid and the information requested.
                                    The applicant shall submit the information requested under point 2 within two years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission.
                                    The applicant shall submit the information requested under point 3 by 10 November 2020 in accordance with Commission Regulation (EU) 2018/605 (3) amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties and the joint guidance document to identify endocrine disrupting substances as adopted by EFSA and ECHA.’

               (1)  Further details on identity and specification of active substance are provided in the renewal report.

               (2)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

               (3)  Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33).


title: Commission Implementing Regulation (EU) 2018/1265 of 20 September 2018 approving the active substance fenpicoxamid in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance.)

text:
                  21.9.2018

                  EN

                  Official Journal of the European Union

                  L 238/77

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1265
         of 20 September 2018
         approving the active substance fenpicoxamid in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending Commission Implementing Regulation (EU) No 540/2011
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 13(2) thereof,
         Whereas:

                     (1)

                     In accordance with Article 7(1) of Regulation (EC) No 1107/2009 the United Kingdom received on 2 December 2014 an application from Dow AgroScience GmbH for the approval of the active substance fenpicoxamid.

                     (2)

                     In accordance with Article 9(3) of that Regulation, the United Kingdom, as rapporteur Member State, notified the applicant, the other Member States, the Commission and the European Food Safety Authority (‘the Authority’) on 13 January 2015 of the admissibility of the application.

                     (3)

                     On 13 October 2016 the rapporteur Member State submitted a draft assessment report to the Commission with a copy to the Authority, assessing whether that active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

                     (4)

                     The Authority complied with Article 12(1) of Regulation (EC) No 1107/2009. In accordance with Article 12(3) of Regulation (EC) No 1107/2009, it requested that the applicant supply additional information to the Member States, the Commission and the Authority. The assessment of the additional information by the rapporteur Member State was submitted to the Authority in the format of an updated draft assessment report on 31 July 2017.

                     (5)

                     On 22 December 2017 the Authority communicated to the applicant, the Member States and the Commission its conclusion (2) on whether the active substance fenpicoxamid can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Authority made its conclusion available to the public.

                     (6)

                     On 23 March 2018 the Commission presented to the Standing Committee on Plants, Animals, Food and Feed the review report for fenpicoxamid and a draft Regulation providing that fenpicoxamid is approved.

                     (7)

                     It has been established with respect to one or more representative uses of at least one plant protection product containing the active substance, and in particular the uses which were examined and detailed in the review report, that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied.

                     (8)

                     It is therefore appropriate to approve fenpicoxamid.

                     (9)

                     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. In particular, it is appropriate to require further confirmatory information.

                     (10)

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

                     (11)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Approval of active substance
            The active substance fenpicoxamid, as specified in Annex I, is approved subject to the conditions laid down in that Annex.

            Article 2
            Amendment to Implementing Regulation (EU) No 540/2011
            The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

            Article 3
            Entry into force
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 20 September 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 309, 24.11.2009, p. 1.

            (2)  EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk assessment of the active substance fenpicoxamid (XDE-777). EFSA Journal 2018;16(1):5146, 27 pp. https://doi.org/10.2903/j.efsa.2018.5146.

            (3)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                        Fenpicoxamid
                        CAS No: 517875-34-2
                        CIPAC No: 991

                        (3S,6S,7R,8R)-8-benzyl-3-{3-[(isobutyryloxy)methoxy]-4-methoxypyridine-2-carboxamido}-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl isobutyrate

                        ≥ 750 g/kg

                        11 October 2018

                        11 October 2028

                        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 fenpicoxamid, and in particular Appendices I and II thereto, shall be taken into account.
                        In this overall assessment Member States shall pay particular attention to:

                                    —

                                    the impact of processing on the consumer risk assessment,

                                    —

                                    the risk to aquatic organisms.

                              Conditions of use shall include risk mitigation measures, where appropriate.
                        The applicant shall submit confirmatory information as regards:

                                    1.

                                    the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification;

                                    2.

                                    the effect of water treatment processes on the nature of residues present in drinking water;

                                    3.

                                    the endocrine disrupting potential of fenpicoxamid as regards the thyroid modality/pathway, providing in particular mechanistic data to clarify according to Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 (2), whether the effects observed in the studies submitted for approval are or are not related to a thyroid endocrine disrupting mode of action.

                              The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 1 by 11 October 2019, in point 2 within 2 years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission and in point 3 by 10 November 2020.

               (1)  Further details on identity and specification of active substance are provided in the review report.

               (2)  Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33).

            ANNEX II
            In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:

                           No

                           Common Name, Identification Numbers

                           IUPAC Name

                           Purity (1)

                           Date of approval

                           Expiration of approval

                           Specific provisions

                           ‘126

                           Fenpicoxamid
                           CAS No: 517875-34-2
                           CIPAC No: 991

                           (3S,6S,7R,8R)-8-benzyl-3-{3-[(isobutyryloxy)methoxy]-4-methoxypyridine-2-carboxamido}-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl isobutyrate

                           ≥ 750 g/kg

                           11 October 2018

                           11 October 2028

                           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 fenpicoxamid, and in particular Appendices I and II thereto, shall be taken into account.
                           In this overall assessment Member States shall pay particular attention to:

                                       —

                                       the impact of processing on the consumer risk assessment,

                                       —

                                       the risk to aquatic organisms.

                                 Conditions of use shall include risk mitigation measures, where appropriate.
                           The applicant shall submit confirmatory information as regards:

                                       1.

                                       the technical specification of the active substance as manufactured (based on commercial scale production) and the compliance of the toxicity batches with the confirmed technical specification;

                                       2.

                                       the effect of water treatment processes on the nature of residues present in drinking water;

                                       3.

                                       the endocrine disrupting potential of fenpicoxamid as regards the thyroid modality/pathway, providing in particular mechanistic data to clarify according to Points 3.6.5 and 3.8.2 of Annex II of Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605 (2), whether the effects observed in the studies submitted for approval are or are not related to a thyroid endocrine disrupting mode of action.

                                 The applicant shall submit to the Commission, the Member States and the Authority the information referred to in point 1 by 11 October 2019, in point 2 within 2 years of a guidance document on evaluation of the effect of water treatment processes on the nature of residues present in surface and groundwater being made public by the Commission and in point 3 by 10 November 2020.’

               (1)  Further details on identity and specification of active substance are provided in the review report.

               (2)  Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. (OJ L 101, 20.4.2018, p. 33).