title: Commission Implementing Regulation (EU) 2018/1630 of 24 October 2018 entering a name in the register of protected designations of origin and protected geographical indications (‘Lička janjetina’ (PGI))

text:
                  31.10.2018

                  EN

                  Official Journal of the European Union

                  L 272/16

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1630
         of 24 October 2018
         entering a name in the register of protected designations of origin and protected geographical indications (‘Lička janjetina’ (PGI))
         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)(a) of Regulation (EU) No 1151/2012, Croatia's application to register the name ‘Lička janjetina’ 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 ‘Lička janjetina’ should therefore be entered in the register,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The name ‘Lička janjetina’ (PGI) is hereby entered in the register.
            The name specified in the first paragraph denotes a product in Class 1.1. — Fresh meat (and offal), 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, 24 October 2018.

                  For the Commission,

                  On behalf of the President,

               Phil HOGAN

                  Member of the Commission

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

            (2)  OJ C 153, 2.5.2018, 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) 2018/1631 of 30 October 2018 authorising the placing on the market of cranberry extract powder as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470 (Text with EEA relevance.)

text:
                  31.10.2018

                  EN

                  Official Journal of the European Union

                  L 272/17

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1631
         of 30 October 2018
         authorising the placing on the market of cranberry extract powder as a novel food under Regulation (EU) 2015/2283 of the European Parliament and of the Council and amending Commission Implementing Regulation (EU) 2017/2470
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

                     Regulation (EU) 2015/2283 provides that only novel foods authorised and included in the Union list may be placed on the market within the Union.

                     (2)

                     Pursuant to Article 8 of Regulation (EU) 2015/2283, Commission Implementing Regulation (EU) 2017/2470 (2) was adopted, which establishes a Union list of authorised novel foods.

                     (3)

                     Pursuant to Article 12 of Regulation (EU) 2015/2283, the Commission is to decide on the authorisation and on the placing on the Union market of a novel food and on updating the Union list.

                     (4)

                     On 20 September 2011, the company Ocean Spray Cranberries Inc. (‘the Applicant’) made a request to the competent authority of France to place cranberry extract powder on the Union market as a novel food within the meaning of point (c) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council (3). The application requested for cranberry extract powder to be used in fruit-flavoured beverages, isotonic beverages, tea beverages, vitamin enhanced waters, yogurts and yogurt drinks.

                     (5)

                     On 11 December 2014, the competent authority of France issued its initial assessment report. In that report it came to the conclusion that cranberry extract powder meets the criteria for novel food ingredients set out in Article 3(1) of Regulation (EC) No 258/97. In the same report, the competent authority of France also expressed concerns regarding possible nutritional risks associated with the overconsumption of polyphenols for children between one and three years of age resulting from the intake of polyphenols from the novel food, and from other sources of polyphenols in children's diet.

                     (6)

                     On 16 January 2015, the Commission forwarded the initial assessment report to the other Member States. Reasoned objections were raised by the other Member States within the 60-day period laid down in the first subparagraph of Article 6(4) of Regulation (EC) No 258/97 with regard to insufficient data excluding the risk for young children aged between one and three years, incomplete specification of the novel food, and lack of information on the protein content needed to exclude allergy risk.

                     (7)

                     In view of the initial assessment report issued by the competent authority of France and the objections raised by some Member States, the Commission consulted the European Food Safety Authority (‘the Authority’) on 20 April 2016, asking it to carry out an additional assessment for cranberry extract powder as a novel food in accordance with Regulation (EC) No 258/97.

                     (8)

                     In contacts with the Authority the Applicant has declared that the novel food is not intended to be marketed to infants, toddlers and children of below 19 years of age.

                     (9)

                     On 4 April 2017, the Authority adopted a ‘Scientific Opinion on the safety of cranberry extract powder as a novel food ingredient pursuant to Regulation (EC) No 258/97’ in which it concluded that cranberry extract is safe for the uses communicated by the Applicant (4). That opinion, although elaborated and adopted by the Authority under Regulation (EC) No 258/97, is in line with the requirements of Article 11 of Regulation (EU) 2015/2283.

                     (10)

                     On 7 June 2017 the Commission informed the applicant of its and certain Member States' positions that, in view of the risk that infants, toddlers and children of below 19 years of age could consume the intended products, an authorisation would require an additional safety evaluation for these age groups. Alternatively, the Commission suggested that the risk of consumption by the age groups for which the Authority had not concluded on safety could be sufficiently contained, if cranberry extract would be authorised as a novel food supplement for the adult population. (5)

                     (11)

                     On 22 December 2017, the Applicant informed the Commission of its decision to, at this stage, pursue the authorisation of cranberry extract for use in food supplements for the general adult population, without prejudice to a subsequent further application for an extension of the conditions of use based on a further safety assessment by the Authority.

                     (12)

                     Pursuant to Article 35(1) of Regulation (EU) 2015/2283, any request for placing a novel food on the market within the Union submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97 and for which the final decision has not been taken before 1 January 2018 shall be treated as an application submitted under Regulation (EU) 2015/2283.The application also meets the requirements laid down in Regulation (EU) 2015/2283.

                     (13)

                     The opinion of the Authority gives sufficient grounds to establish that cranberry extract powder, when used in food supplements for general adult population, complies with Article 12(1) of Regulation (EU) 2015/2283.

                     (14)

                     On 2 May 2018, the applicant made a request to the Commission for protection of proprietary data for three studies submitted in support of the application namely, a ten-week clinical study in healthy adults (6), a twelve-week clinical study in adults with low to moderate cardiovascular disease risk (7) and a report on the influence on systemic immune functions, urinary and systemic biomarkers of health and faecal characteristics of human subjects during a 10 weeks administration (8). The applicant also made a request to the Commission for protection of proprietary data for consumption information of their cranberry juice cocktail product in Europe, as well as consumption information relating to children (9). A request to the Commission for protection of proprietary data was also made for the compositional data (10) and the intake estimate on cranberry beverage consumption (11).

                     (15)

                     On 27 June 2018, the Authority considered (12) that in elaborating its opinion on cranberry extract powder as a novel food, the compositional information (Table IX.b-1, original application, dated June 2011, page 24) and the intake estimate on cranberry beverage consumption (File: ‘Ocean Spray's response to Member States' objections’, dated November 2015) were needed for the characterisation and setting of specifications of the novel food, as well as for hazard identification, and for the assessment whether the potential intake of proanthocyanidins (PAC) from the novel food is comparable to the PAC intake from the consumption of cranberry juice products. Therefore, it is considered that the conclusions on the safety of cranberry extract powder could not have been reached without the aforementioned data.

                     (16)

                     Following the receipt of the Authority's opinion, the Commission requested the applicant to further clarify the justification provided with regard to their proprietary claim over the data, and their claim to an exclusive right of reference to that data, as referred to in points (a) and (b) of Article 26(2) of Regulation (EU) 2015/2283.

                     (17)

                     The applicant declared that, at the time the application was submitted, it held proprietary and exclusive rights of reference to the evidence and data under national law and that therefore third parties could not lawfully access or use that scientific evidence or scientific data. The Commission assessed all the information provided by the applicant and considered that the applicant has sufficiently substantiated the fulfilment of the requirements laid down in Article 26(2) of Regulation (EU) 2015/2283.

                     (18)

                     Accordingly, as provided for under Article 26(2) of Regulation (EU) 2015/2283, the compositional data and the intake estimate contained in the applicant's file and without which the novel food could not have been assessed by the Authority should not be used by for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation. As a consequence, the placing on the market within the Union of the novel food authorised by this Regulation should be restricted to the applicant for a period of five years.

                     (19)

                     However, restricting the authorisation of this novel food and of the reference to the scientific evidence or scientific data contained in the applicant's file for the sole use of the applicant does not prevent other applicants from applying for an authorisation to place on the market the same novel food provided that their application is based on legally obtained information supporting the authorisation under this Regulation.

                     (20)

                     Directive 2002/46/EC lays down requirements on food supplements. The use of cranberry extract powder should be authorised without prejudice to the requirements of that Directive.

                     (21)

                     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

               1.   Cranberry extract powder as specified in the Annex to this Regulation shall be included in the Union list of authorised novel foods established in Implementing Regulation (EU) 2017/2470.

               2.   For a period of five years from the date of entry into force of this Regulation only the Applicant:

                           —

                           Company: Ocean Spray Cranberries Inc.

                           —

                           Address: One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, USA;

                     is authorised to place on the market within the Union the novel food referred to in paragraph 1, unless a subsequent applicant obtains authorisation for the same novel food without reference to the data protected pursuant to Article 2 of this Regulation or with the agreement of Ocean Spray Cranberries Inc.

               3.   The entry in the Union list referred to in paragraph 1 shall include the conditions of use and labelling requirements laid down in the Annex to this Regulation.

               4.   The authorisation provided for in this Article shall be without prejudice to the provisions of Directive 2002/46/EC.

            Article 2
            The data contained in the application file on the basis of which the novel food referred to in Article 1 has been assessed by the Authority, claimed by the applicant as fulfilling the requirements laid down in Article 26(2) of Regulation (EC) No 2015/2283, shall not be used for the benefit of a subsequent applicant for a period of five years from the date of entry into force of this Regulation without the agreement of Ocean Spray Cranberries Inc.

            Article 3
            The Annex to Implementing Regulation (EU) 2017/2470 is amended in accordance with the Annex to this Regulation.

            Article 4
            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, 30 October 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 327, 11.12.2015, p. 1.

            (2)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

            (3)  Regulation (EC) No 258/97 of the European Parliament and of the Council concerning novel foods and novel foods ingredients (OJ L 43, 14.2.1997, p. 1).

            (4)  EFSA Journal 2017; 15(5):4777.

            (5)  Food supplements are subject to specific labelling and marketing requirements pursuant to Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

            (6)  Nantz et al., unpublished manuscript.

            (7)  Juturu et al., unpublished manuscript.

            (8)  Unpublished Report.

            (9)  Original application, dated June 2011.

            (10)  Table IX.b-1, Original application, dated June 2011, page 24.

            (11)  Ocean Spray's response to Member States' objections, dated November 2015.

            (12)  EFSA Scientific Panel on Dietetic Products, Nutrition and Allergies, Minutes of XXX. Plenary held on 28-29 June 2018.

            ANNEX
            The Annex to Implementing Regulation (EU) 2017/2470 is amended as follows:

                        (1)

                        The following last column is added in Table 1 (Authorised novel foods):
                        ‘Data protection’

                        (2)

                        The following entry is inserted in Table 1 (Authorised novel foods) in alphabetical order:

                                    ‘Authorised novel food

                                    Conditions under which the novel food may be used

                                    Additional specific labelling requirements

                                    Other requirements

                                    Data protection

                                    Cranberry extract powder

                                       Specified food category

                                       Maximum levels

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘cranberry extract powder’

                                    Authorised on 20 November 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: Ocean Spray Cranberries Inc. One Ocean Spray Drive Lakeville-Middleboro, MA, 02349, USA.
                                    During the period of data protection the novel food, cranberry extract powder, is authorised for placing on the market within the Union only by Ocean Spray Cranberries Inc. unless a subsequent applicant obtains authorisation for the novel food without reference to the proprietary scientific evidence or scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283 or with the agreement of Ocean Spray Cranberries Inc.
                                    End date of the data protection: 20 November 2023.’

                                    Food Supplements as defined in Directive 2002/46/EC for the adult population

                                    350 mg/day

                        (3)

                        The following entry is inserted in Table 2 (Specifications) in alphabetical order:

                                    ‘Authorised Novel Food

                                    Specification

                                    Cranberry extract powder

                                       Description/Definition:

                                    Cranberry extract powder is a water-soluble phenolic-rich powder extract prepared through an ethanolic extraction from the juice concentrate of sound, mature berries of the cranberry cultivar Vaccinium macrocarpon.

                                       Characteristics/Composition

                                    Moisture (% w/w): ≤ 4
                                    Proanthocyanidins — PACs (% w/w dry weight)

                                                —

                                                OSC-DMAC method (1)
                                                    (3): 55.0-60.0 or

                                                —

                                                BL-DMAC method (2)
                                                    (3): 15.0-18.0

                                          Total phenolics (GAE (4), % w/w dry weight) (3)

                                                —

                                                Folin-Ciocalteau method: > 46.2

                                          Solubility (water): 100 %, with no visible insoluble particles
                                    Ethanol Content (mg/kg): ≤ 100
                                    Screen Analysis: 100 % through 30 mesh screen
                                    Appearance and aroma, as powder: Free-flowing, deep red colour. Earthy aroma with no burnt character.

                                       Heavy metals:

                                    Arsenic (ppm): < 3

                                       Microbiological criteria:

                                    Yeast: < 100 CFU (5)/g
                                    Mould: < 100 CFU/g
                                    Aerobic plate count: < 1 000  CFU/g
                                    Coliforms: < 10 CFU/g

                                       Escherichia coli: < 10 CFU/g

                                       Salmonella: Absent in 375 g

               (1)  OSC-DMAC (4-dimethylaminocinnamaldehyde) method (Ocean Spray Cranberries, Inc) Martin MA, Ramos S, Mateos R, Marais JPJ, Bravo-Clemente, L, Khoo C and Goya L. Food Res Intl 2015 71: 68-82. Modified from Cunningham DG, Vannozzi S, O'Shea E, Turk R (2002) In: Ho C-T, Zheng QY (eds) Quality Management of Nutraceuticals ACS Symposium series 803, Washington DC. Quantitation of PACs by DMAC Color Reaction pp 151-166.

               (2)  BL-DMAC 4-dimethylaminocinnamaldehyde) method (Brunswick Lab) Multi-laboratory validation of a standard method for quantifying proanthocyanidins in cranberry powders. Prior RL, Fan E, Ji H, Howell A, Nio C, Payne MJ, Reed J. J Sci Food Agric. 2010 Jul;90(9):1473-8.

               (3)  The different values for these three parameters are due to the different methods used.

               (4)  GAE: Gallic Acid Equivalents

               (5)  CFU: Colony Forming Units’


title: Commission Implementing Regulation (EU) 2018/1650 of 5 November 2018 amending Annex I to Regulation (EC) No 798/2008 as regards the entries for Canada, Russia and the United States in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union in relation to highly pathogenic avian influenza (Text with EEA relevance.)

text:
                  6.11.2018

                  EN

                  Official Journal of the European Union

                  L 275/10

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1650
         of 5 November 2018
         amending Annex I to Regulation (EC) No 798/2008 as regards the entries for Canada, Russia and the United States in the list of third countries, territories, zones or compartments from which certain poultry commodities may be imported into or transit through the Union in relation to highly pathogenic avian influenza
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Directive 2002/99/EC of 16 December 2002 laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption (1), and in particular the introductory phrase of Article 8, the first subparagraph of point 1 of Article 8, point 4 of Article 8 and Article 9(4)(c) thereof,
         Having regard to Council Directive 2009/158/EC of 30 November 2009 on animal health conditions governing intra-Community trade in, and imports from third countries of, poultry and hatching eggs (2), and in particular Articles 23(1), 24(2) and Article 25 thereof,
         Whereas:

                     (1)

                     Commission Regulation (EC) No 798/2008 (3) lays down veterinary certification requirements for imports into and transit, including storage during transit, through the Union of poultry and poultry products (the commodities). It provides that the commodities are only to be imported into and transit through the Union from the third countries, territories, zones or compartments listed in columns 1 and 3 of the table in Part 1 of Annex I thereto.

                     (2)

                     Regulation (EC) No 798/2008 provides that consignments of commodities may only be imported into and transit through the Union if they comply with certain conditions, including the specific conditions set out in column 6 of the table in Part 1 of Annex I thereto, and where appropriate, the ‘closing date’ and ‘opening date’ set out in columns 6A and 6B of that table. The closing date indicates the date from which consignments of commodities produced in a third country, territory, zone or compartment are no longer authorised for import into or transit through the Union, while the opening date indicates the date from which consignments of commodities produced in a third country, territory, zone or compartment are again authorised for import into or transit through the Union.

                     (3)

                     The entries in columns 6A and 6B are kept in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 to prevent the import into and transit through the Union of consignments of commodities produced in the restricted zones outside the Union during the period when the import into and transit through the Union of such consignments was not authorised in accordance with the rules laid down in that Regulation.

                     (4)

                     The entry for Canada in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 includes zones of that third country which, following the confirmation of HPAI, have applied stamping out, cleaning and disinfection and have been re-authorised for imports into and transit through the Union of certain poultry commodities with an opening date of more than two years ago. The entry for Canada should therefore be amended accordingly.

                     (5)

                     The entry for the United States in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 includes zones of that third country which, following the confirmation of HPAI, have applied stamping out, cleaning and disinfection and have been re-authorised for imports into and transit through the Union of certain poultry commodities with an opening date of more than two years ago. The entry for the United States should therefore be amended accordingly.

                     (6)

                     Regulation (EC) No 798/2008 also lays down the conditions for a third country, territory, zone or compartment to be considered as free from HPAI.

                     (7)

                     Russia is listed in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 as a third country from which imports into and transit through the Union of certain poultry commodities are authorised from the whole of its territory.

                     (8)

                     On 17 November 2016, Russia confirmed the presence of HPAI of subtype H5N8 in a poultry holding on its territory. Since November 2016, Russia has confirmed several outbreaks of HPAI in poultry holdings on its territory. Due to those confirmed outbreaks since November 2016 Russia cannot be considered as free from that disease and the veterinary authorities of Russia are not in a position to certify consignments of meat of poultry for human consumption intended for import into or transit through the Union.

                     (9)

                     The veterinary authorities of Russia have submitted information to the Commission on the outbreaks of HPAI and have confirmed that since 17 November 2016 they have suspended issuing veterinary certificates for consignments of meat of poultry for human consumption intended for import into or transit through the Union.

                     (10)

                     Therefore, no consignments of such products originating in Russia have been introduced into the Union since that date. For reasons of clarity and legal certainty, it is appropriate to document this situation and introduce in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 the relevant closing date. This also ensures that, where Russia regains freedom from HPAI and an opening date is established, consignments of such products produced after the closing date and before that opening date will not be eligible for introduction into the Union.

                     (11)

                     The entry for Russia in the table in Part 1 of Annex I to Regulation (EC) No 798/2008 should therefore be amended to take account of the epidemiological situation in that third country since November 2016 and indicate the closing date from which that third country cannot be considered as free from HPAI

                     (12)

                     Annex I to Regulation (EC) No 798/2008 should therefore be amended accordingly.

                     (13)

                     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
            Part 1 of Annex I to Regulation (EC) No 798/2008 is amended in accordance with the Annex to this Regulation.

            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, 5 November 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 18, 23.1.2003, p. 11.

            (2)  OJ L 343, 22.12.2009, p. 74.

            (3)  Commission Regulation (EC) No 798/2008 of 8 August 2008 laying down a list of third countries, territories, zones or compartments from which poultry and poultry products may be imported into and transit through the Community and the veterinary certification requirements (OJ L 226, 23.8.2008, p. 1).

            ANNEX
            Part 1 of Annex I to Regulation (EC) No 798/2008 is amended as follows:

                        (1)

                        the entry for Canada is replaced by the following:

                                    ISO code and name of third country or territory

                                    Code of third country, territory, zone or compartment

                                    Description of third country, territory, zone or compartment

                                    Veterinary certificate

                                    Specific conditions

                                    Specific conditions

                                    Avian influenza surveillance status

                                    Avian influenza vaccination status

                                    Salmonella Control Status (6)

                                    Model(s)

                                    Additional guarantees

                                    Closing date (1)

                                    Opening date (2)

                                    1

                                    2

                                    3

                                    4

                                    5

                                    6

                                    6A

                                    6B

                                    7

                                    8

                                    9

                                    ‘CA-Canada

                                    CA-0

                                    Whole country

                                    SPF

                                    EP, E

                                    S4

                                    CA-1

                                    The whole country of Canada excluding area CA-2

                                    WGM

                                    VIII

                                    BPR, BPP, DOC, DOR, HEP, HER, SRP, SRA, LT20

                                    N

                                    A

                                    S1, ST1’

                                    POU, RAT

                                    N

                                    CA-2

                                    Territory of Canada corresponding to: none

                        (2)

                        the entry for Russia is replaced by the following:

                                    ISO code and name of third country or territory

                                    Code of third country, territory, zone or compartment

                                    Description of third country, territory, zone or compartment

                                    Veterinary certificate

                                    Specific conditions

                                    Specific conditions

                                    Avian influenza surveillance status

                                    Avian influenza vaccination status

                                    Salmonella Control Status (6)

                                    Model(s)

                                    Additional guarantees

                                    Closing date (1)

                                    Opening date (2)

                                    1

                                    2

                                    3

                                    4

                                    5

                                    6

                                    6A

                                    6B

                                    7

                                    8

                                    9

                                    ‘RU-Russia

                                    RU-0

                                    Whole country

                                    EP, E

                                    S4’

                                    POU

                                    P2

                                    17.11.2016

                        (3)

                        the entry for the United States is replaced by the following:

                                    ISO code and name of third country or territory

                                    Code of third country, territory, zone or compartment

                                    Description of third country, territory, zone or compartment

                                    Veterinary certificate

                                    Specific conditions

                                    Specific conditions

                                    Avian influenza surveillance status

                                    Avian influenza vaccination status

                                    Salmonella Control Status (6)

                                    Model(s)

                                    Additional guarantees

                                    Closing date (1)

                                    Opening date (2)

                                    1

                                    2

                                    3

                                    4

                                    5

                                    6

                                    6A

                                    6B

                                    7

                                    8

                                    9

                                    ‘US – United States

                                    US-0

                                    Whole country

                                    SPF

                                    EP, E

                                    S4

                                    US-1

                                    The whole country of the United States excluding area US-2

                                    WGM

                                    VIII

                                    POU, RAT

                                    N

                                    BPP, BPR, DOC, DOR, HEP, HER, SRP, SRA, LT20

                                    A

                                    S3, ST1

                                    US-2

                                    Territory of the United States corresponding to:

                                    US-2.1

                                    State of Tennessee:

                                                Lincoln County

                                                Franklin County

                                                Moore County

                                    WGM

                                    VIII

                                    P2

                                    4.3.2017

                                    11.8.2017

                                    POU, RAT

                                    N
                                    P2

                                    BPR, BPP, DOC, DOR, HEP, HER, SRP, SRA, LT20

                                    A

                                    S3, ST1

                                    US-2.2

                                    State of Alabama:

                                                Madison County

                                                Jackson County

                                    WGM

                                    VIII

                                    P2

                                    4.3.2017

                                    11.8.2017

                                    POU, RAT

                                    N
                                    P2

                                    BPR, BPP, DOC, DOR, HEP, HER, SRP, SRA, LT20

                                    A

                                    S3, ST1’


title: Commission Implementing Regulation (EU) 2018/1795 of 20 November 2018 laying down procedure and criteria for the application of the economic equilibrium test pursuant to Article 11 of Directive 2012/34/EU of the European Parliament and of the Council (Text with EEA relevance.)

text:
                  21.11.2018

                  EN

                  Official Journal of the European Union

                  L 294/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1795
         of 20 November 2018
         laying down procedure and criteria for the application of the economic equilibrium test pursuant to Article 11 of Directive 2012/34/EU of the European Parliament and of the Council
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (1), and in particular the second subparagraph of Article 11(4) thereof,
         Whereas:

                     (1)

                     Directive 2012/34/EU as amended by Directive (EU) 2016/2370 (2) has opened up the market for domestic rail passenger services with a view to completing the single European railway area. This may have implications for the organisation and financing of rail passenger services provided under a public service contract. Member States may introduce in their legislation the possibility to deny access to the infrastructure where the economic equilibrium of such public service contracts would be compromised by new open access rail passenger services.

                     (2)

                     On the other hand, such services, depending on their specific features, such as quality characteristics, timing, destinations served and prospective customers targeted, may not be in head-on competition with public services, and thus cause only limited impact on the economic equilibrium of a public service contract. Furthermore, there may be positive network effects for public service operators, net benefits to passengers or wider social benefits that should be taken into account.

                     (3)

                     It is therefore necessary to balance the legitimate interests of operators performing a public service contract and competent authorities, on the one hand, with the overarching objectives of completing the single European railway area and reaping its wider social benefits, on the other hand. The economic equilibrium test should achieve a balance between those competing interests.

                     (4)

                     Regulation (EC) No 1370/2007 of the European Parliament and of the Council (3) lays down that, as a reward for discharging public service obligations in the provision of rail passenger services, operators may be granted financial compensation or exclusive rights, or both. However, the grant of exclusive rights to railway operators should not result in the foreclosure of domestic rail passenger markets.

                     (5)

                     Such exclusive rights should not preclude the right of access of other railway undertakings, unless the economic equilibrium test shows that, taking into account the value of the exclusive rights, the new rail passenger service would have a substantial negative impact on the profitability of services operated under the public service contract or the net cost of their provision for the competent authority, or both, depending on risk-sharing arrangements stipulated in the public service contract.

                     (6)

                     An economic equilibrium test should be requested only in respect of passenger rail services which are not provided under a public service contract and which are either entirely new or entail a substantial modification of an existing service. This notion encompasses also commercial services provided by the same operator that carries out the public service contract.

                     (7)

                     It should be for the regulatory body to assess whether a proposed modification of a rail passenger service should be considered substantial. An increase in frequencies or number of stops could be considered a substantial modification. A variation in prices should not be considered a substantial modification, unless it is inconsistent with normal market behaviour, and where relevant, with the business plan submitted to the regulatory body at the time the previous economic equilibrium test was carried out.

                     (8)

                     The regulatory body's decision should include an assessment of net benefits to customers arising from the new rail passenger service in the short and medium term, and should take into account the technical information provided by the infrastructure manager on relevant infrastructure requirements and on expected impacts on network performance and on optimal capacity utilisation by all applicants.

                     (9)

                     The regulatory body should be entitled both to assess the likely impact of the new passenger service, and to assess whether such impact would be substantial and thus compromise the economic equilibrium of the existing public service contract.

                     (10)

                     In order to avoid the interruption of a new rail passenger service that has already started, and to give legal certainty to this new service about its possibility to operate, the period during which an economic equilibrium test can be requested should be limited and linked to the time of the applicant's notification of its interest in operating a new rail passenger service.

                     (11)

                     To be admissible, a request for an economic equilibrium test should include substantiation that the economic equilibrium of the public service contract would be compromised by the proposed new service.

                     (12)

                     In order to ensure legal certainty for all parties involved and to enable the infrastructure manager to process requests for capacity according to the procedure set out in Section 3 of Chapter IV of Directive 2012/34/EU, the regulatory body should take a decision on economic equilibrium within a pre-determined time frame, and in any event before the deadline for receipt of requests of capacity, set by the infrastructure manager in accordance with point 3 of Annex VII to Directive 2012/34/EU.

                     (13)

                     However, if at the time the applicant's notification is received, a public service contract is in the process of being competitively tendered and an economic equilibrium test has been requested, the regulatory body may decide to suspend consideration of the application for the new rail passenger service for a limited period of time pending the award of the new public service contract. The suspension should last for no longer than 12 months from the receipt of the applicant's notification or until the tender process has concluded, whichever is sooner.
                     These specific provisions are without prejudice to the application of this regulation to a public service contract which is on-going at the time the applicant's notification is received. In these circumstances, and where the economic equilibrium test on the existing public service contract demonstrates that access can be granted, such access should be time-limited until the expiry of the existing public service contract.

                     (14)

                     The economic equilibrium of a public service contract should be regarded as compromised if the proposed new service would have a substantial negative impact on the level of profit for the public service operator and/or their operation would imply a substantial increase in net cost for the competent authority.

                     (15)

                     When assessing whether an impact is substantial, the regulatory body should take into account criteria such as whether the new service would jeopardise the viability and endanger the continuity of the public service, either because performance of the public contract would not be economically sustainable for the public service operator, or because it would entail a substantial increase in net cost for the competent authority.

                     (16)

                     Beyond the economic analysis, the regulatory body should also assess and take into account the net benefits to customers in the short and medium term and any impacts in network performance and capacity use. The regulatory body should take into account the technical information provided by the infrastructure manager on relevant infrastructure requirements, on expected impacts on network performance and on optimal capacity utilisation by all applicants.

                     (17)

                     The economic analysis should focus on the impact of the proposed new service on the public service contract as a whole, including the services specifically affected, for its entire time-scale, taking into account the value of any existing exclusive rights that may have been granted. No predefined quantified threshold regarding the damage should be applied strictly or in isolation, and no such thresholds should be set in national legislation. The assessment should be based on an objective methodology adopted by the regulatory body having regard to the specificities of rail transport in the Member State concerned.

                     (18)

                     When the regulatory body comes to the conclusion that the new rail passenger service would compromise the economic equilibrium of the public service contract, in its decision it should indicate, if relevant, possible changes to the new rail passenger service which would enable access to be granted. The regulatory body may issue recommendations to the competent authority as regards other possible conditions that would enable access to be granted, in particular in the light of its analysis of net benefits to customers arising from the new rail passenger service.

                     (19)

                     If the application for access concerns a new rail passenger service as defined in Article 3(36) of Directive 2012/34/EU and the objective economic analysis of the regulatory body shows that the new passenger service would have a substantial negative impact on the economic equilibrium of a public service contract, the regulatory body should determine conditions which would enable access to be granted in accordance with Article 11a of Directive 2012/34/EU.

                     (20)

                     In all its activities related to the economic equilibrium test, the regulatory body should not disclose confidential or commercially sensitive information received from the parties. In particular, it should redact such information from the decision to be published. All decisions of regulatory bodies, including those on the confidential nature of the information received, are subject to judicial review according to Article 56(10) of Directive 2012/34/EU.

                     (21)

                     Where the economic equilibrium test is carried out in respect of a new international passenger service, without prejudice to the principle of independence of regulatory bodies in decision-making referred to in Article 55(1) of Directive 2012/34/EU, the regulatory bodies concerned should exchange information and cooperate to achieve a reasonable resolution of the matter.

                     (22)

                     Regulatory bodies should exchange best practices in applying the economic equilibrium test with a view to adapting their methodology over time and developing a consistent methodology across Member States, which may be covered by Article 57(8) of Directive 2012/34/EU.

                     (23)

                     Commission Implementing Regulation (EU) No 869/2014 (4) establishes criteria and procedures for the application of the principal purpose test and the economic equilibrium test in respect of new international rail passenger services. However, with the opening of the market for domestic rail passenger services, the principal purpose test has become obsolete and the same criteria and procedures should apply to all new rail passenger services, regardless of whether they are domestic or international. Implementing Regulation (EU) No 869/2014 should therefore be repealed.

                     (24)

                     Since Articles 10 and 11(1) of Directive 2012/34/EU apply from 1 January 2019 but are not applicable to train services which start to run before 12 December 2020, there is a need to continue applying Commission Implementing Regulation (EU) No 869/2014 after 1 January 2019, but only for new rail passenger services intended to start before 12 December 2020. The application of Implementing Regulation (EU) No 869/2014 should be conditional on applicants' notifications being submitted within a time-frame that allows reasonable time for completion of the authorisation and scheduling process so that the services can actually start to run before 12 December 2020.

                     (25)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 62(1) of Directive 2012/34/EU,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Subject matter
            This Regulation sets out the details of the procedure and criteria to be followed when determining whether the economic equilibrium of a public service contract for rail transport would be compromised by a new rail passenger service.

            Article 2
            Scope
            This Regulation applies to situations where a Member State has decided to limit the right of access referred to in Article 10(2) Directive 2012/34/EU for new rail passenger services between a given place of departure and a given destination when one or more public service contracts cover the same route or an alternative route, as provided for in Article 11(1) of that Directive.

            Article 3
            Definitions
            For the purposes of this Regulation, the following definitions shall apply:

                        (1)

                        ‘new rail passenger service’ means a rail passenger service designed to be operated as a regular time-tabled service, that is either entirely new, or that implies a substantial modification of an existing rail passenger service, in particular in terms of increased frequencies of services or increased number of stops, and which is not provided under a public service contract;

                        (2)

                        ‘economic equilibrium test’ means the assessment process described in Article 11(1) to (4) and Article 11a of Directive 2012/34/EU and further described in Article 10 and carried out by a regulatory body at the request of one of the entities referred to in Article 11(2) of Directive 2012/34/EU in order to determine whether the economic equilibrium of a public service contract would be compromised by the proposed new rail passenger service;

                        (3)

                        ‘public service contract’ means a public service contract as defined in point (i) of Article 2 of Regulation (EC) No 1370/2007 in the area of rail transport;

                        (4)

                        ‘competent authority’ means a competent authority as defined in point (b) of Article 2 of Regulation (EC) No 1370/2007;

                        (5)

                        ‘net financial impact’ means the impact of the new rail passenger service on the net balance of costs and revenues arising from the discharge of the public service obligations stipulated in a public service contract, which includes reasonable profit;

                        (6)

                        ‘exclusive right’ means a right as defined in point (f) of Article 2 of Regulation (EC) No 1370/2007.

            Article 4
            Notification of a planned new rail passenger service

               1.   The applicant shall notify the infrastructure managers and the regulatory bodies concerned of its intention to operate a new rail passenger service in accordance with the deadline set in Article 38(4) of Directive 2012/34/EU.

               2.   Regulatory bodies shall develop and publish on their website a standard notification form to be completed and submitted by the applicant, which shall be limited to the following information:

                           (a)

                           the applicant's name, address, legal entity, registration number (if appropriate);

                           (b)

                           contact data of the person responsible for queries;

                           (c)

                           data of licence and safety certificate of the applicant or indication of the stage of the procedure to obtain them;

                           (d)

                           detailed route indicating location of departure and destination stations as well as all intermediate stops;

                           (e)

                           planned starting date for the operation of the proposed new rail passenger service;

                           (f)

                           indicative timing, frequency and capacity of the proposed new rail passenger service, including proposed departure times, arrival times and connections as well as any deviations in frequency or in stops from the standard timetable, in each direction;

                           (g)

                           indicative information on the rolling stock the applicant plans to use.

               3.   The information regarding the planned operation of the new rail passenger service shall cover at least the first three years and, as far as possible, the first five years of operation. The regulatory body may however agree to a shorter period.

               4.   The regulatory body shall publish on its website the standard notification form submitted by the applicant and shall notify the following without undue delay and at the latest within 10 days of receiving a complete notification form:

                           (a)

                           any competent authority that has awarded a public service contract for a rail passenger service on that route or an alternative route within the meaning of Directive 2012/34/EU;

                           (b)

                           any other interested competent authority with the right to limit access under Article 11 of Directive 2012/34/EU;

                           (c)

                           any railway undertaking operating services under public service contract on the route of the new rail passenger service or an alternative route.

               5.   All information provided by the applicant via the standard notification form and any supporting documents shall be sent to the regulatory bodies and infrastructure managers in electronic form. However, the regulatory body may, in duly justified cases, accept that documents be submitted in paper format.

               6.   If the notification is incomplete, the regulatory body shall inform the applicant that incomplete requests will not be considered and shall give the applicant the possibility to complete its request within a reasonable time not exceeding ten working days.

            Article 5
            Deadline for requesting the economic equilibrium test

               1.   Any request for an economic equilibrium test shall be made to the regulatory body by the entities referred to in the first subparagraph of Article 11(2) of Directive 2012/34/EU within the deadline set out in that provision.

               2.   Where, at the time of receipt of the applicant's notification referred to in Article 4 a public service contract covering the same route or an alternative route is being competitively tendered and the deadline for submitting bids to the competent authority has expired, an economic equilibrium test may be requested within the deadline referred to in paragraph 1 by the entities referred to in Article 11(2) of Directive 2012/34/EU in respect of the future public service contract.
               This is without prejudice to the application of this regulation to a public service contract which is on-going at the time of the applicant's notification.

               3.   If no request for an economic equilibrium test is made within the deadline referred to in paragraph 1, the regulatory body shall inform the applicant and the infrastructure manager without delay. The infrastructure manager shall process the access request in accordance with Section 3 of Chapter IV of Directive 2012/34/EU.

            Article 6
            Public service contracts with exclusive rights
            Where a competent authority has granted exclusive rights to the railway undertaking performing a public service contract in accordance with Article 3 of Regulation (EC) No 1370/2007, the existence of such rights shall not preclude access being granted to an applicant for the purpose of operating a new rail passenger service, provided that access would not compromise the economic equilibrium of the public service contract.
            In carrying out the test pursuant to Article 10, the regulatory body shall give due consideration to the value of any such exclusive rights.

            Article 7
            Information requirements for the economic equilibrium test

               1.   The entity requesting the economic equilibrium test shall provide the following information:

                           (a)

                           the requesting entity's name, address, legal entity, registration number (if appropriate);

                           (b)

                           contact information of the person responsible for queries;

                           (c)

                           substantiation that the economic equilibrium of the contract risks being compromised by the new rail passenger service;

                           (d)

                           if the requesting entity is a competent authority or the railway undertaking performing the public service contract, a copy of the public service contract.

               2.   The regulatory body may request any necessary information, including, as the case may be:

                           (a)

                           from the competent authority:

                                       (1)

                                       relevant traffic, demand and revenue forecasts, including forecast methodology,

                                       (2)

                                       where appropriate, the methodology and data used to calculate the net financial effect pursuant to Article 6(1) of Regulation (EC) No 1370/2007 and the Annex to that Regulation;

                           (b)

                           from the railway undertaking performing the public service contract:

                                       (1)

                                       copy of the public service contract, if not provided under point (d) of paragraph 1,

                                       (2)

                                       the undertaking's business plan for the route covered by the public service contract or an alternative route,

                                       (3)

                                       relevant traffic, demand and revenue forecasts, including forecast methodology,

                                       (4)

                                       information on revenues and profit margins gained by the undertaking on the route covered by the public service contract or an alternative route,

                                       (5)

                                       timetable information for the services, including departure times, intermediate stops, arrival times and connections,

                                       (6)

                                       estimated elasticities of the services (e.g. price elasticity, elasticity with respect to quality characteristics of the services),

                                       (7)

                                       cost of capital and operating costs for services provided under the public service contract, as well as variations in costs and demand induced by the new rail passenger service;

                           (c)

                           from the applicant, information concerning its plans for operating the new rail passenger service, including:

                                       (1)

                                       business plan,

                                       (2)

                                       forecast of passenger traffic and revenues, including forecast methodology,

                                       (3)

                                       pricing strategies,

                                       (4)

                                       ticketing arrangements,

                                       (5)

                                       rolling stock specifications (e.g. load factor, number of seats, vehicle configuration),

                                       (6)

                                       marketing strategy;

                           (d)

                           from the infrastructure manager:

                                       (1)

                                       information regarding the relevant lines or sections, in order to ensure that the new rail passenger service can be run on the infrastructure concerned,

                                       (2)

                                       information on potential performance and resilience impacts of the proposed new rail passenger service,

                                       (3)

                                       assessment of impacts on capacity use,

                                       (4)

                                       plans for developing infrastructure as regards routes covered by the proposed new rail passenger service, including an indication of the time when any such plans will be implemented,

                                       (5)

                                       information on relevant framework agreements concluded or under discussion, in particular with the undertaking performing the public service contract.

                     The information obligations of the infrastructure manager set out in point (d) of the first subparagraph of this paragraph shall be without prejudice to its obligations under the allocation procedure referred to in Section 3 of Chapter IV of Directive 2012/34/EU.

               3.   All information shall be sent to the regulatory body in electronic form. The regulatory body may, however, in duly justified cases, accept that documents be submitted in paper format.

            Article 8
            Confidentiality

               1.   The regulatory body shall not disclose commercially sensitive information received from the parties in connection with the economic equilibrium test.

               2.   The entity requesting the economic equilibrium test and the applicant shall substantiate any proposed non-disclosure of commercially sensitive information at the time the information is provided to the regulatory body. Such information may include, in particular, technical or financial information relating to an undertaking's know-how, business plan, cost structures, marketing and pricing strategies, supply sources and market shares. The regulatory body shall redact any commercially sensitive information from its decision before its notification and publication in accordance with Article 11(5). Information included in the standard notification form, as specified in Article 4(2), shall not be considered commercially sensitive.

               3.   If the regulatory body finds that the reasons for non-disclosure provided under paragraph 2 cannot be accepted, that decision shall be communicated and justified in writing to the party requesting confidentiality, at the latest two weeks before adoption of the decision referred to in Article 11(1).

               4.   The regulatory body's decision on confidentiality shall be subject to judicial review according to Article 56(10) of Directive 2012/34/EU. The regulatory body shall not disclose the disputed information until the national court has issued a ruling on confidentiality.

            Article 9
            Procedure for the economic equilibrium test

               1.   The regulatory body may request the entity requesting the economic equilibrium test to provide it with any additional information it deems necessary in accordance with Article 7(2) within one month of receiving the request. The requesting entity shall provide such information within a reasonable deadline set by the regulatory body. The regulatory body may request further information if it considers that the additional information received is not sufficient.

               2.   In the event that six weeks before the final date for receipt of requests for capacity set in accordance with point 3 of Annex VII to Directive 2012/34/EU the information provided by the requesting entity is still incomplete, the regulatory body shall perform the test on the basis of available information. If, however, the regulatory body considers that the information is insufficient to perform the test, it shall reject the request.

               3.   Within one month of receiving the request for the economic equilibrium test, the regulatory body shall also ask other parties referred to in Article 7(2) to provide it with the information necessary to perform the test in accordance with that provision, to the extent that such information can reasonably be provided by the party concerned. Where the information thus provided is incomplete, the regulatory body may request further clarifications, setting reasonable deadlines.

               4.   In the event that six weeks before the final date for receipt of requests for capacity set in accordance with point 3 of Annex VII to Directive 2012/34/EU the information provided by the applicant seeking access is still incomplete the regulatory body shall perform the test on the basis of available information. If, however, the regulatory body considers that the information provided by the applicant is insufficient to perform the test, it shall adopt a decision resulting in access being denied.

               5.   Where the undertaking performing the public service contract is not the requesting entity, and where six weeks before the final date for receipt of requests for capacity set in accordance with point 3 of Annex VII to Directive 2012/34/EU the information provided by this undertaking is still incomplete, the regulatory body shall perform the test on the basis of available information. If, however, the regulatory body considers that the information provided is insufficient to perform the test, it shall adopt a decision resulting in access being granted.

               6.   The regulatory body shall adopt a decision within six weeks from the receipt of all relevant information, and in any event before the final date for receipt of requests for capacity set in accordance with point 3 of Annex VII to Directive 2012/34/EU. The regulatory body shall inform the infrastructure manager of its decision without delay.

               7.   Where a request for the economic equilibrium test is made according to Article 5(2) in respect of a public service contract which is in the process of being competitively tendered, the regulatory body may suspend consideration of the proposed application for a new rail passenger service for a maximum period of 12 months from receipt of the applicant's notification of the new rail passenger service or until the tender process has concluded, whichever is the sooner.

            Article 10
            Contents of the economic equilibrium test and assessment criteria

               1.   The regulatory body shall assess whether the economic equilibrium of a public service contract would be compromised by the proposed new rail passenger service. Economic equilibrium shall be considered as compromised where the new rail passenger service would have a substantial negative impact on at least one of the following elements:

                           (a)

                           the profitability of services that the railway undertaking operates under the public service contract;

                           (b)

                           the net cost for the competent authority awarding the public service contract.

               2.   The analysis shall refer to the public service contract as a whole, not to individual services operated under it, over its entire duration. Predetermined thresholds or specific criteria may be applied but not strictly or in isolation from other criteria.

               3.   The regulatory body shall assess the net financial impact of the new rail passenger service on the public service contract. The analysis of costs and revenues generated in operating the services covered by the public service contract after the market entry of the new rail passenger service shall include the following elements:

                           (a)

                           variation in costs incurred and revenues obtained by the railway undertaking performing the public service contract (including where relevant any cost savings, such as those arising from the non-replacement of rolling stock reaching the end of its useful life or staff whose contract ends);

                           (b)

                           financial effects generated within the network under public service contract by the proposed new rail passenger service (such as bringing passengers who might be interested in a connection with a regional service covered by the public service contract);

                           (c)

                           possible competitive responses by the railway undertaking performing the public service contract;

                           (d)

                           impact on relevant investments by railway undertakings, or by competent authorities, for example in rolling stock;

                           (e)

                           the value of any existing exclusive rights.

               4.   The regulatory body shall assess the significance of the impact taking into account, in particular, the contractual arrangements in place between the competent authority and the railway undertaking operating the public services, including where applicable the level of compensation determined in accordance with the Annex to Regulation (EC) No 1370/2007 or resulting from competitive award and any mechanisms for sharing risks such as traffic and revenue risks.

               5.   The regulatory body shall also assess:

                           (a)

                           the net benefits to customers arising from the new rail passenger service in the short and medium term;

                           (b)

                           the impact of the new rail passenger service on the performance and quality of railway services;

                           (c)

                           the impact of the new rail passenger service on timetable planning for railway services.

               6.   Where the regulatory body is examining more than one application for access, it may take different decisions on the applications received, based on an analysis of their respective impacts on the economic equilibrium of the public service contract, competitive effects, net benefits to customers and network impacts, and of their cumulative effects on the economic equilibrium of the public service contract.

               7.   The assessment carried out in accordance with this Article is without prejudice to the regulatory body's obligation to report State aid issues to the national authorities in accordance with the second subparagraph of Article 56(12) of Directive 2012/34/EU.

            Article 11
            Result of the economic equilibrium test

               1.   As a result of the economic equilibrium test carried out in accordance with Articles 9 and 10, the regulatory body shall take a decision provided for in Article 11(2) of Directive 2012/34/EU, on the basis of which the right of access to the rail infrastructure shall be granted, modified, granted only under conditions or denied.

               2.   Where the economic equilibrium of a public service contract would be compromised by the new rail passenger service, the regulatory body:

                           (a)

                           shall, as appropriate, indicate possible changes to that new rail passenger service, such as a modification of frequencies, paths, intermediate stops or schedule, which would ensure that the conditions for granting the right of access provided for in Article 10(2) of Directive 2012/34/EU are met; and/or

                           (b)

                           may issue recommendations to the competent authorities, where relevant in the light of net benefits to customers referred to in point (a) of Article 10(5) of this Regulation, concerning other changes not related to the new passenger service that would ensure that the conditions for granting the right of access are met.

               3.   Where the request for access concerns the operation of a new service as defined by Article 3(36) of Directive 2012/34/EU, following the procedure and analysis laid down in this regulation, the regulatory body shall act in accordance with Article 11a of Directive 2012/34/EU.

               4.   In the circumstances described in Article 5(2) second subparagraph, where the economic equilibrium test on the existing public service contract demonstrates that access can be granted, it shall be time-limited, pending the outcome of the economic equilibrium test to be carried out in accordance with Article 5(2), first paragraph and Article 9(7).

               5.   The regulatory body shall notify a non-confidential version of its decision to the entities listed in Article 11(3) of Directive 2012/34/EU and publish it on its website.

            Article 12
            Cooperation between regulatory bodies competent for a proposed new international passenger service

               1.   Upon receipt of an applicant's notification of its intention to start a new international passenger service, the regulatory body shall inform the other regulatory bodies having competence for the route of the proposed new service. The regulatory bodies concerned shall check the information received and inform each other of any inconsistencies.

               2.   Upon receipt of a request from the entities referred to in Article 11(2) of Directive 2012/34/EU for an economic equilibrium test, the regulatory body shall inform thereof the other competent regulatory bodies.

               3.   Regulatory bodies shall provide each other with the results of their respective economic equilibrium tests in order to give the other regulatory bodies sufficient opportunity to comment on the results of those tests before they are finalised. They shall cooperate in order to bring about a resolution of the matter in accordance with Article 57 of Directive 2012/34/EU.

               4.   During any exchange of information regarding the tests, regulatory bodies shall respect the confidentiality of commercially sensitive information received from the parties involved in the tests. They may only use the information for the case concerned.

            Article 13
            Fees
            A Member State or the regulatory body may decide that a fee be paid for the economic equilibrium test by the entity requesting the test.

            Article 14
            Methodology

               1.   The methodology used by the regulatory body to perform the test shall be clear, transparent and non-discriminatory and shall be published on its website.

               2.   Regulatory bodies shall exchange experiences and best practices in applying their respective methodologies in the context of the network established in Article 57(1) of Directive 2012/34/EU.

            Article 15
            Repeal
            Implementing Regulation (EU) No 869/2014 is repealed with effect from 12 December 2020. It shall apply to applicants' notifications received after 1 January 2019 only where these are submitted sufficiently in advance for the new rail passenger services to be able to start before 12 December 2020.

            Article 16
            Entry into force and application
            This Regulation shall enter into force on the twentieth day following that of its publication the Official Journal of the European Union.
            It shall apply from 1 January 2019, in time for the working timetable starting on 12 December 2020.

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

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 343, 14.12.2012, p. 32.

            (2)  Directive (EU) 2016/2370 of the European Parliament and of the Council of 14 December 2016 amending Directive 2012/34/EU as regards the opening of the market for domestic passenger transport services by rail and the governance of the railway infrastructure (OJ L 352, 23.12.2016, p. 1).

            (3)  Regulation (EC) No 1370/2007 of the European Parliament and of the Council of 23 October 2007 on public passenger transport services by rail and by road and repealing Council Regulations (EEC) Nos 1191/69 and 1107/70 (OJ L 315, 3.12.2007, p. 1).

            (4)  Commission Implementing Regulation (EU) No 869/2014 of 11 August 2014 on new rail passenger services (OJ L 239, 12.8.2014, p. 1).


title: Commission Implementing Regulation (EU) 2018/1796 of 20 November 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances amidosulfuron, bifenox, chlorpyrifos, chlorpyrifos-methyl, clofentezine, dicamba, difenoconazole, diflubenzuron, diflufenican, dimoxystrobin, fenoxaprop-p, fenpropidin, lenacil, mancozeb, mecoprop-p, metiram, nicosulfuron, oxamyl, picloram, pyraclostrobin, pyriproxyfen and tritosulfuron (Text with EEA relevance.)

text:
                  21.11.2018

                  EN

                  Official Journal of the European Union

                  L 294/15

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1796
         of 20 November 2018
         amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances amidosulfuron, bifenox, chlorpyrifos, chlorpyrifos-methyl, clofentezine, dicamba, difenoconazole, diflubenzuron, diflufenican, dimoxystrobin, fenoxaprop-p, fenpropidin, lenacil, mancozeb, mecoprop-p, metiram, nicosulfuron, oxamyl, picloram, pyraclostrobin, pyriproxyfen and tritosulfuron
         (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 the first paragraph of Article 17 thereof,
         Whereas:

                     (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)

                     The approval periods of the active substances chlorpyrifos, chlorpyrifos-methyl, dimoxystrobin, mancozeb, mecoprop-p, metiram, oxamyl and pyraclostrobin were last extended by Commission Implementing Regulation (EU) 2018/84 (3). The approval periods of those substances will expire on 31 January 2019.

                     (3)

                     The approval period of the active substance tritosulfuron will expire on 30 November 2018.

                     (4)

                     The approval periods of the active substances amidosulfuron, bifenox, clofentezine, dicamba, difenoconazole, diflubenzuron, diflufenican, fenoxaprop-p, fenpropidin, lenacil, nicosulfuron, picloram and pyriproxyfen will expire on 31 December 2018.

                     (5)

                     Applications for the renewal of the approval of those substances were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (4).

                     (6)

                     Due to the fact that the assessment of those substances has been delayed for reasons beyond the control of the applicants, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

                     (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 an active substance referred to in the Annex to 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 an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.

                     (8)

                     Taking into account that the approval period of the active substance tritosulfuron expires on 30 November 2018, this Regulation should enter into force as soon as possible.

                     (9)

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

                     (10)

                     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
            The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

            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, 20 November 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  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).

            (3)  Commission Implementing Regulation (EU) 2018/84 of 19 January 2018 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).

            (4)  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).

            ANNEX
            Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                        (1)

                        in the sixth column, expiration of approval, of row 57, Mecoprop-P, the date is replaced by ‘31 January 2020’;

                        (2)

                        in the sixth column, expiration of approval, of row 81, Pyraclostrobin, the date is replaced by ‘31 January 2020’;

                        (3)

                        in the sixth column, expiration of approval, of row 111, Chlorpyrifos, the date is replaced by ‘31 January 2020’;

                        (4)

                        in the sixth column, expiration of approval, of row 112, Chlorpyrifos-methyl, the date is replaced by ‘31 January 2020’;

                        (5)

                        in the sixth column, expiration of approval, of row 114, Mancozeb, the date is replaced by ‘31 January 2020’;

                        (6)

                        in the sixth column, expiration of approval, of row 115, Metiram, the date is replaced by ‘31 January 2020’;

                        (7)

                        in the sixth column, expiration of approval, of row 116, Oxamyl, the date is replaced by ‘31 January 2020’;

                        (8)

                        in the sixth column, expiration of approval, of row 128, Dimoxystrobin, the date is replaced by ‘31 January 2020’;

                        (9)

                        in the sixth column, expiration of approval, of row 169, Amidosulfuron, the date is replaced by ‘31 December 2019’;

                        (10)

                        in the sixth column, expiration of approval, of row 170, Nicosulfuron, the date is replaced by ‘31 December 2019’;

                        (11)

                        in the sixth column, expiration of approval, of row 171, Clofentezine, the date is replaced by ‘31 December 2019’;

                        (12)

                        in the sixth column, expiration of approval, of row 172, Dicamba, the date is replaced by ‘31 December 2019’;

                        (13)

                        in the sixth column, expiration of approval, of row 173, Difenoconazole, the date is replaced by ‘31 December 2019’;

                        (14)

                        in the sixth column, expiration of approval, of row 174, Diflubenzuron, the date is replaced by ‘31 December 2019’;

                        (15)

                        in the sixth column, expiration of approval, of row 176, Lenacil, the date is replaced by ‘31 December 2019’;

                        (16)

                        in the sixth column, expiration of approval, of row 178, Picloram, the date is replaced by ‘31 December 2019’;

                        (17)

                        in the sixth column, expiration of approval, of row 179, Pyriproxyfen, the date is replaced by ‘31 December 2019’;

                        (18)

                        in the sixth column, expiration of approval, of row 180, Bifenox, the date is replaced by ‘31 December 2019’;

                        (19)

                        in the sixth column, expiration of approval, of row 181, Diflufenican, the date is replaced by ‘31 December 2019’;

                        (20)

                        in the sixth column, expiration of approval, of row 182, Fenoxaprop-P, the date is replaced by ‘31 December 2019’;

                        (21)

                        in the sixth column, expiration of approval, of row 183, Fenpropidin, the date is replaced by ‘31 December 2019’;

                        (22)

                        in the sixth column, expiration of approval, of row 186, Tritosulfuron, the date is replaced by ‘30 November 2019’.


title: Commission Implementing Regulation (EU) 2018/1794 of 20 November 2018 amending Implementing Regulation (EU) 2015/220 laying down rules for the application of Council Regulation (EC) No 1217/2009 setting up a network for the collection of accountancy data on the incomes and business operation of agricultural holdings in the European Union

text:
                  21.11.2018

                  EN

                  Official Journal of the European Union

                  L 294/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1794
         of 20 November 2018
         amending Implementing Regulation (EU) 2015/220 laying down rules for the application of Council Regulation (EC) No 1217/2009 setting up a network for the collection of accountancy data on the incomes and business operation of agricultural holdings in the European Union
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 1217/2009 of 30 November 2009 setting up a network for the collection of accountancy data on the incomes and business operation of agricultural holdings in the European Union (1), and in particular Articles 5a(2) and 19(3) thereof,
         Whereas:

                     (1)

                     Article 12 of Commission Implementing Regulation (EU) 2015/220 (2) sets out the total number of duly completed and submitted farm returns per Member State that are eligible for the payment of the standard fee. Article 19(1)(a) of Regulation (EC) No 1217/2009 provides for a reduction of the standard fee to 80 % where the total number of duly completed and delivered farm returns in respect of a FADN division or a Member State is less than 80 % of the number of returning holdings laid down for that FADN division or for the Member State concerned. In order to ensure a fair application of that provision, it should not be possible to compensate for non-delivered farm returns in a FADN division for which less than 80 % of the number of returning holdings laid down for that FADN division was submitted by the Member State.

                     (2)

                     Article 14(4) of Implementing Regulation (EU) 2015/220 sets a 2-month deadline for the validation of submitted farm returns in relation to their potential eligibility for the payment of the increased standard fee. In order to provide more clarity as regards the duration of that period, it should be expressed in working days in the Member State concerned. In addition, the Commission should have the possibility to extend that period in exceptional and duly justified cases.

                     (3)

                     Implementing Regulation (EU) 2015/220 should therefore be amended accordingly.

                     (4)

                     Having regard to the nature of the amendments, it is appropriate that they apply as from the accounting year 2018.

                     (5)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Farm Accountancy Data Network,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Implementing Regulation (EU) 2015/220 is amended as follows:

                        (1)

                        in Article 12, the following paragraph is added:
                        ‘However, farm returns from a FADN division with a higher number of submitted farm returns than laid down for that FADN division in Annex II shall not be considered as eligible for the payment of the standard fee in a FADN division for which less than 80 % of the required number of returning holdings is submitted by the Member State.’;

                        (2)

                        in Article 14, paragraph 4 is replaced by the following:

                           ‘4.   To the increase of the standard fee under points (a) and (b) of paragraph 3 may be added EUR 2 for the accounting year 2018 and EUR 5 from the accounting year 2019 where the accountancy data has been verified by the Commission in accordance with point (b) of the first paragraph of Article 13 of this Regulation and is deemed duly completed in accordance with Article 8(2) of Regulation (EC) No 1217/2009, either at the moment of its submission to the Commission, or within 40 working days from the date on which the Commission informed the submitting Member State that the submitted accountancy data is not duly completed.
                           In exceptional and duly justified cases, the Commission may decide to extend that period of 40 working days.
                           The end date of the period of 40 working days, or of any extension thereof, shall be confirmed in writing between the Commission and the liaison agency of the Member State concerned.’.

            Article 2
            This Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union.
            It shall apply from the accounting year 2018.

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

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 328, 15.12.2009, p. 27.

            (2)  Commission Implementing Regulation (EU) 2015/220 of 3 February 2015 laying down rules for the application of Council Regulation (EC) No 1217/2009 setting up a network for the collection of accountancy data on the incomes and business operation of agricultural holdings in the European Union (OJ L 46, 19.2.2015, p. 1).