title: Commission Implementing Regulation (EU) 2018/1128 of 9 August 2018 amending Implementing Regulation (EU) No 1354/2011 opening annual Union tariff quotas for sheep, goats, sheepmeat and goatmeat

text:
                  14.8.2018

                  EN

                  Official Journal of the European Union

                  L 205/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1128
         of 9 August 2018
         amending Implementing Regulation (EU) No 1354/2011 opening annual Union tariff quotas for sheep, goats, sheepmeat and goatmeat
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular points (a) and (b) of Article 187 thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) No 1354/2011 (2) provides for the opening of annual Union import tariff quotas for sheep, goats, sheepmeat and goatmeat, including those originating in Iceland.

                     (2)

                     Article 4 of Implementing Regulation (EU) No 1354/2011 provides that the tariff quotas opened by that Regulation are to be managed in accordance with Articles 49 to 54 of Commission Implementing Regulation (EU) 2015/2447 (3).

                     (3)

                     The European Union and Iceland signed an Agreement in the form of an Exchange of Letters (hereafter ‘the Agreement’) concerning additional trade preferences in agricultural products on 23 March 2017. The signature of the Agreement on behalf of the Union was authorised by Council Decision (EU) 2016/2087 (4) and its conclusion by Council Decision (EU) 2017/1913 (5).

                     (4)

                     In accordance with Annex V to the Agreement, the Union amended Regulation (EU) No 1354/2011 by Commission Implementing Regulation (EU) 2018/562 (6). The amendment increased the quantities of the pre-existing duty-free quotas for Iceland for sheepmeat and goatmeat, falling within tariff headings 0204 and 0210, and furthermore opened an annual Union duty-free quota for processed sheepmeat falling within subheading 1602 90.

                     (5)

                     The quantities of the sheepmeat and goatmeat quotas managed under Implementing Regulation (EU) No 1354/2011 are expressed in carcass-weight equivalent, whereas the Agreement provides for the quantities to be expressed in tonnes of products. It is therefore appropriate to provide for the management of the Union tariff quotas which are set out in the Agreement in a separate Regulation to be adopted, in order to ensure a smooth quota management pursuant to Regulation (EU) No 952/2013 of the European Parliament and of the Council (7). As a consequence, those tariff quotas should be simultaneously removed from Implementing Regulation (EU) No 1354/2011 based on Regulation (EU) No 1308/2013.

                     (6)

                     It is therefore necessary to amend Implementing Regulation (EU) No 1354/2011 accordingly.

                     (7)

                     The new Regulation opening the import tariff quotas for sheepmeat and goatmeat and processed sheepmeat originating in Iceland adopted pursuant to Regulation (EU) No 952/2013 will apply from 1 September 2018. Therefore, the corresponding amendments to Implementing Regulation (EU) No 1354/2011 should apply from the same date.

                     (8)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Implementing Regulation (EU) No 1354/2011 is amended as follows:

                        (1)

                        in Article 3(2), point (e) is deleted;

                        (2)

                        the Annex is replaced by the text in 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.
            It shall apply from 1 September 2018.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 9 August 2018.

                  For the Commission,

                  On behalf of the President,

               Günther OETTINGER

                  Member of the Commission

            (1)  OJ L 347, 20.12.2013, p. 671.

            (2)  Commission Implementing Regulation (EU) No 1354/2011 of 20 December 2011 opening annual Union tariff quotas for sheep, goats, sheepmeat and goatmeat (OJ L 338, 21.12.2011, p. 36).

            (3)  Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code (OJ L 343, 29.12.2015, p. 558).

            (4)  Council Decision (EU) 2016/2087 of 14 November 2016 on the signing, on behalf of the European Union, of the Agreement in the form of an Exchange of Letters between the European Union and Iceland concerning additional trade preferences in agricultural products (OJ L 324, 30.11.2016, p. 1).

            (5)  Council Decision (EU) 2017/1913 of 9 October 2017 on the conclusion of the Agreement in the form of an Exchange of Letters between the European Union and Iceland concerning additional trade preferences in agricultural products (OJ L 274, 24.10.2017, p. 57).

            (6)  Commission Implementing Regulation (EU) 2018/562 of 9 April 2018 amending Implementing Regulation (EU) No 1354/2011 opening annual Union tariff quotas for sheep, goats, sheepmeat and goatmeat (OJ L 94, 12.4.2018, p. 4).

            (7)  Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1).

            ANNEX
            ‘

                     ANNEX
                     SHEEPMEAT AND GOATMEAT (in tonnes (t) of carcass weight equivalent) UNION TARIFF QUOTAS

                                 CN codes

                                 “Ad valorem” duty
                                 (%)

                                 Specific duty
                                 EUR/100 kg

                                 Order number under “first-come first-served”

                                 Origin

                                 Annual volume in tonnes of carcass weight equivalent

                                 Live animals
                                 (Coefficient = 0,47)

                                 Boneless lamb (1)

                                 (Coefficient = 1,67)

                                 Boneless mutton/sheep (2)

                                 (Coefficient = 1,81)

                                 Bone-in and carcasses
                                 (Coefficient = 1,00)

                                 0204

                                 Zero

                                 Zero

                                 —

                                 09.2101

                                 09.2102

                                 09.2011

                                 Argentina

                                 23 000

                                 —

                                 09.2105

                                 09.2106

                                 09.2012

                                 Australia

                                 19 186

                                 —

                                 09.2109

                                 09.2110

                                 09.2013

                                 New Zealand

                                 228 254

                                 —

                                 09.2111

                                 09.2112

                                 09.2014

                                 Uruguay

                                 5 800

                                 —

                                 09.2115

                                 09.2116

                                 09.1922

                                 Chile (3)

                                 8 000

                                 —

                                 09.2121

                                 09.2122

                                 09.0781

                                 Norway

                                 300

                                 —

                                 09.2125

                                 09.2126

                                 09.0693

                                 Greenland

                                 100

                                 —

                                 09.2129

                                 09.2130

                                 09.0690

                                 Faeroes

                                 20

                                 —

                                 09.2131

                                 09.2132

                                 09.0227

                                 Turkey

                                 200

                                 —

                                 09.2171

                                 09.2175

                                 09.2015

                                 Others (4)

                                 200

                                 —

                                 09.2178

                                 09.2179

                                 09.2016

                                    Erga omnes
                                     (5)

                                 200

                                 0104 10 30
                                 0104 10 80
                                 0104 20 90

                                 10

                                 Zero

                                 09.2181

                                 —

                                 —

                                 09.2019

                                    Erga omnes
                                     (5)

                                 92

               ’

               (1)  And goatmeat of kid.

               (2)  And goatmeat other than kid.

               (3)  Tariff quota for Chile increases by 200 t per annum.

               (4)  “Others” shall refer to all WTO members, excluding Argentina, Australia, New Zealand, Uruguay, Chile, Greenland and Iceland.

               (5)  “Erga omnes” shall refer to all origins including the countries mentioned in the current table.


title: Commission Implementing Regulation (EU) 2018/1129 of 13 August 2018 approving acetamiprid as an existing active substance for use in biocidal products of product-type 18 (Text with EEA relevance.)

text:
                  14.8.2018

                  EN

                  Official Journal of the European Union

                  L 205/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1129
         of 13 August 2018
         approving acetamiprid as an existing active substance for use in biocidal products of product-type 18
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the third subparagraph of Article 89(1) thereof,
         Whereas:

                     (1)

                     Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes acetamiprid.

                     (2)

                     Acetamiprid has been evaluated for use in products of product-type 18, insecticides, acaricides and products to control other arthropods, as described in Annex V to Regulation (EU) No 528/2012.

                     (3)

                     Belgium was designated as rapporteur Member State and its evaluating competent authority submitted the assessment report together with its recommendations on 27 July 2015.

                     (4)

                     In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 14 December 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority (3).

                     (5)

                     According to that opinion, biocidal products of product-type 18 containing acetamiprid may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

                     (6)

                     It is therefore appropriate to approve acetamiprid for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.

                     (7)

                     The opinion of the European Chemicals Agency concludes that acetamiprid meets the criteria for being a very persistent (vP) and toxic (T) substance in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4). Acetamiprid therefore meets the conditions set out in point (d) of Article 10(1) of Regulation (EU) No 528/2012 and should be considered a candidate for substitution.

                     (8)

                     Pursuant to Article 10(4) of Regulation (EU) No 528/2012, the approval of an active substance that is considered as a candidate for substitution should be for a period not exceeding seven years.

                     (9)

                     Since acetamiprid meets the criteria for being very persistent (vP) in accordance with Annex XIII to Regulation (EC) No 1907/2006, treated articles treated with or incorporating acetamiprid should be appropriately labelled when placed on the market.

                     (10)

                     A reasonable period should be allowed to elapse before an active substance is approved, in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

                     (11)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Acetamiprid is approved as an active substance for use in biocidal products of product-type 18, subject to the specifications and conditions set out in the Annex.

            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, 13 August 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 167, 27.6.2012, p. 1.

            (2)  Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1).

            (3)  Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance Acetamiprid, Product type: 18, ECHA/BPC/185/2017, Adopted on 14 December 2017.

            (4)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

            ANNEX

                        Common Name

                        IUPAC Name
                        Identification Numbers

                        Minimum degree of purity of the active substance (1)

                        Date of approval

                        Expiry date of approval

                        Product type

                        Specific conditions

                        Acetamiprid

                        IUPAC Name:
                        (E)-N1-[(6-chloro-3-pyridyl)methyl]-N2-cyano-N1-methylacetamide
                        EC No: None
                        CAS No: 135410-20-7

                        99,0 % w/w

                        1 February 2020

                        31 January 2027

                        18

                        Acetamiprid is considered a candidate for substitution in accordance with point (d) of Article 10(1) of Regulation (EU) No 528/2012.
                        The authorisations of biocidal products are subject to the following conditions:

                                    1.

                                    The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.

                                    2.

                                    In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:

                                                (a)

                                                professional users;

                                                (b)

                                                infants and toddlers following secondary exposure when the product is sprayed by professionals;

                                                (c)

                                                surface water, sediment, soil, groundwater for products applied by spray or brush in stables;

                                                (d)

                                                surface water, sediment, soil, groundwater for products applied by spray outdoors.

                                    3.

                                    For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council (2) or Regulation (EC) No 396/2005 of the European Parliament and of the Council (3) shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.

                              The placing on the market of treated articles is subject to the following condition:
                        The person responsible for the placing on the market of a treated article treated with or incorporating acetamiprid shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

               (1)  The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.

               (2)  Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

               (3)  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).


title: Commission Implementing Regulation (EU) 2018/1131 of 13 August 2018 approving penflufen as an active substance for use in biocidal products of product-type 8 (Text with EEA relevance.)

text:
                  14.8.2018

                  EN

                  Official Journal of the European Union

                  L 205/12

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1131
         of 13 August 2018
         approving penflufen as an active substance for use in biocidal products of product-type 8
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 9(1)(a) thereof,
         Whereas:

                     (1)

                     The evaluating competent authority of the United Kingdom received on 7 July 2015 an application for the approval of the active substance penflufen for use in biocidal products of product-type 8, wood preservatives, as described in Annex V to Regulation (EU) No 528/2012.

                     (2)

                     The evaluating competent authority of the United Kingdom submitted the assessment report together with its recommendations on 28 February 2017 in accordance with Article 8(1) of Regulation (EU) No 528/2012.

                     (3)

                     The opinion of the European Chemicals Agency was formulated on 14 December 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority (2).

                     (4)

                     According to that opinion, biocidal products of product-type 8 containing penflufen may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

                     (5)

                     It is therefore appropriate to approve penflufen for use in biocidal products of product-type 8, subject to compliance with certain specifications and conditions.

                     (6)

                     Since the opinion of the European Chemical Agency concludes that penflufen meets the criteria for being very persistent (vP) in accordance with Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3), treated articles treated with or incorporating penflufen should be labelled appropriately when placed on the market.

                     (7)

                     A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

                     (8)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Penflufen is approved as an active substance for use in biocidal products of product-type 8, subject to the specifications and conditions set out in the Annex.

            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, 13 August 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 167, 27.6.2012, p. 1.

            (2)  Biocidal Products Committee (BPC) Opinion on the application for approval of the active substance Penflufen, Product type: 8, ECHA/BPC/184/2017, Adopted on 14 December 2017.

            (3)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

            ANNEX

                        Common Name

                        IUPAC Name
                        Identification Numbers

                        Minimum degree of purity of the active substance (1)

                        Date of approval

                        Expiry date of approval

                        Product type

                        Specific conditions

                        Penflufen

                        IUPAC Name:
                        5-fluoro-1,3-dimethyl-N-{2-[(2RS)-4-methylpentan-2-yl]phenyl}-1H-pyrazole-4-carboxamide
                        EC No: not available
                        CAS No: 494793-67-8

                        980 g/kg (1:1 ratio (R:S) ratio of enantiomers)

                        1 February 2019

                        31 January 2029

                        8

                        The authorisations of biocidal products are subject to the following conditions:

                                    1.

                                    The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.

                                    2.

                                    In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:

                                                (a)

                                                industrial and professional users;

                                                (b)

                                                soil and groundwater for wood in service that will be exposed to frequent weathering.

                                    3.

                                    In view of the risks identified for soil, labels, and, where provided, safety data sheets of product authorised shall indicate that industrial application shall be conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber shall be stored after treatment under shelter or on impermeable hardstanding, or both, to prevent direct losses to soil or water, and that any losses from the application of the product shall be collected for reuse or disposal.

                              The placing on the market of treated articles is subject to the following condition:
                        The person responsible for the placing on the market of a treated article treated with or incorporating penflufen shall ensure that the label of that treated article provides the information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

               (1)  The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.


title: Commission Implementing Regulation (EU) 2018/1133 of 13 August 2018 authorising the placing on the market of dried aerial parts of Hoodia parviflora 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:
                  14.8.2018

                  EN

                  Official Journal of the European Union

                  L 205/18

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1133
         of 13 August 2018
         authorising the placing on the market of dried aerial parts of Hoodia parviflora 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 of the European Parliament and of the Council 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 authorisation and on the placing on the Union market of a novel food and on the updating of the Union list.

                     (4)

                     On 21 October 2014, the company Desert Labs, Ltd (‘the applicant’) made a request to the competent authority of Ireland to place dried aerial parts of Hoodia parviflora on the Union market as a novel food within the meaning of point (e) of Article 1(2) of Regulation (EC) No 258/97 of the European Parliament and of the Council (3). The application requests for dried aerial parts of Hoodia parviflora to be used in foods including beverages, biscuits, confectionary, savoury snacks, soups and broths, tea, coffee and water. It is also intended for use in food supplements.

                     (5)

                     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.

                     (6)

                     While the request for placing dried aerial parts of Hoodia parviflora on the market as a novel food within the Union was submitted to a Member State in accordance with Article 4 of Regulation (EC) No 258/97, the application also meets the requirements laid down in Regulation (EU) 2015/2283.

                     (7)

                     On 24 August 2015, the competent authority of Ireland issued its initial assessment report. In that report, it came to the conclusion that dried aerial parts of Hoodia parviflora meets the criteria for novel food set out in Article 3(1) of Regulation (EC) No 258/97.

                     (8)

                     On 28 August 2015, the Commission forwarded the initial assessment report to the other Member States. Reasoned objections were raised by some 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 characterisation of the novel food, limited assessment of allergenicity, insufficient data to exclude the risk for children older than 12 years, insufficient information on the specifications, stability, intake assessment and on toxicological data.

                     (9)

                     In view of the objections raised by some Member States, the Commission consulted the European Food Safety Authority (‘the Authority’) on 25 January 2016, asking it to carry out an additional assessment for dried aerial parts of Hoodia parviflora as novel food in accordance with Regulation (EC) No 258/97.

                     (10)

                     On 20 September 2017, the Authority adopted ‘Scientific Opinion on the safety of dried aerial parts of Hoodia parviflora as a novel food pursuant to Regulation (EC) No 258/97’ (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.

                     (11)

                     In its opinion, the Authority did not establish the safety of dried aerial parts of Hoodia parviflora in foods at the uses and use levels proposed by the applicant because the intake would exceed the level which is considered as safe (0,134 mg/kg bw). However, the Authority concluded that dried aerial parts of Hoodia parviflora are safe for adults when added to food supplements at a maximum daily dose of 9,4 mg which corresponds to the safe level of intake for an adult with a default body weight of 70 kg.

                     (12)

                     That opinion gives sufficient grounds to establish that dried aerial parts of Hoodia parviflora in the proposed uses and use levels when used as an ingredient in food supplements, comply with Article 12(1) of Regulation (EU) 2015/2283.

                     (13)

                     On 24 January 2018, the applicant made a request to the Commission for protection of proprietary data for two studies submitted in support of the application namely, reports of the 14-day dose-finding oral toxicity study of dried aerial parts of Hoodia parviflora (5), and of the 90-day oral toxicity study (6), served as basis for the Bench Mark Dose (BMD) analysis and for deriving safe intake levels for human.

                     (14)

                     On 18 February 2018, the Authority considered (7) that in elaborating its opinion on dried aerial parts of Hoodia parviflora as a novel food the data from the report of the 90-day oral toxicity study served as basis for the BMD analysis and for deriving safe intake levels for humans. Therefore, it is considered that the conclusions on the safety of dried aerial parts of Hoodia parviflora, could not have been reached without the data from the report of that study.

                     (15)

                     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 study, and their claim to an exclusive right of reference to that study, as referred to in points (a) and (b) of Article 26(2) of Regulation (EU) 2015/2283.

                     (16)

                     The applicant has also declared that, at the time the application was submitted, it held proprietary and exclusive rights of reference to the study under national law and that therefore third parties could not lawfully access or use that study. 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.

                     (17)

                     Accordingly, as provided for under Article 26(2) of Regulation (EU) 2015/2283, the 90-day oral toxicity study contained in the applicant's file should not be used by EFSA 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.

                     (18)

                     However, restricting the authorisation of this novel food and of the reference to the study 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.

                     (19)

                     Directive 2002/46/EC of the European Parliament and of the Council (8) lays down requirements on food supplements. The use of dried aerial parts of Hoodia parviflora should be authorised without prejudice to that Directive.

                     (20)

                     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.   Dried aerial parts of Hoodia parviflora 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: Desert Labs, Ltd

                           Address: Kibbutz Yotvata, 88820, Israel

                     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 Desert Labs, Ltd.

               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 study 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 (EU) 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 Desert Labs, Ltd.

            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, 13 August 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(10):5002.

            (5)  Desert Labs, 2012a, unpublished.

            (6)  Desert Labs, 2012b, unpublished.

            (7)  EFSA Scientific Panel on Dietetic Products, Nutrition and Allergies, Minutes of the 83rd Plenary held on 7-8 February 2018 and agreed on 18 February 2018 (https://www.efsa.europa.eu/sites/default/files/event/180207-1-m.pdf).

            (8)  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).

            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

                                    ‘Dried aerial parts of Hoodia parviflora

                                       Specified food category

                                       Maximum levels

                                    The designation of the novel food on the labelling of the foodstuffs containing it shall be “dried aerial parts of Hoodia parviflora”

                                    Authorised on 3 September 2018. This inclusion is based on proprietary scientific evidence and scientific data protected in accordance with Article 26 of Regulation (EU) 2015/2283.
                                    Applicant: Desert Labs, Ltd Kibbutz Yotvata, 88820 Israel.
                                    During the period of data protection the novel food dried aerial parts of Hoodia parviflora is authorised for placing on the market within the Union only by Desert Labs, Ltd 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 Desert Labs, Ltd.
                                    End date of the data protection: 3 September 2023.’

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

                                    9,4 mg/day

                        (3)

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

                                    Authorised Novel Food

                                    Specification

                                    ‘Dried aerial parts of Hoodia parviflora

                                       Description/Definition:

                                    It is the whole dried aerial parts of Hoodia parviflora N.E.Br., (family Apocynaceae)

                                       Characteristics/Composition

                                    Plant material: Aerial parts of at least 3-year-old plants
                                    Appearance: Light green to tan fine powder
                                    Solubility (water): > 25 mg/mL
                                    Moisture: < 5,5 %
                                    Aw: < 0,3
                                    pH: < 5,0
                                    Protein: < 4,5 g/100 g
                                    Fat: < 3 g/100 g
                                    Carbohydrate (including dietary fibre): < 80 g/100 g
                                    Dietary fibre: < 55 g/100 g
                                    Total sugars: < 10,5 g/100 g
                                    Ash: < 20 %

                                       Hoodigosides

                                    P57: 5–50 mg/kg
                                    L: 1 000 –6 000  mg/kg
                                    O: 500–5 000  mg/kg
                                    Total: 1 500 –11 000  mg/kg

                                       Heavy metals:

                                    Arsenic: < 1,00 mg/kg
                                    Mercury: < 0,1 mg/kg
                                    Cadmium: < 0,1 mg/kg
                                    Lead: < 0,5 mg/kg

                                       Microbiological criteria:

                                    Aerobic plate count: < 105 CFU/g

                                       Escherichia coli: < 10 CFU/g

                                       Staphylococcus aureus: < 50 CFU/g
                                    Total coliforms: < 10 CFU/g
                                    Yeast: ≤ 100 CFU/g
                                    Mould: ≤ 100 CFU/g

                                       Salmonella species: Negative/25 g

                                       Listeria monocytogenes: Negative/25 g
                                    CFU: Colony Forming Units’


title: Commission Implementing Regulation (EU) 2018/1138 of 13 August 2018 amending for the 289th time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations

text:
                  14.8.2018

                  EN

                  Official Journal of the European Union

                  LI 205/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1138
         of 13 August 2018
         amending for the 289th time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the ISIL (Da'esh) and Al-Qaida organisations (1), and in particular Article 7(1)(a) and Article 7a(1) thereof,
         Whereas:

                     (1)

                     Annex I to Regulation (EC) No 881/2002 lists the persons, groups and entities covered by the freezing of funds and economic resources under that Regulation.

                     (2)

                     On 9 August 2018, the Sanctions Committee of the United Nations Security Council decided to add one entry to the list of persons, groups and entities to whom the freezing of funds and economic resources should apply. Annex I to Regulation (EC) No 881/2002 should therefore be amended accordingly.

                     (3)

                     In order to ensure that the measures provided for in this Regulation are effective it should enter into force immediately,

               HAS ADOPTED THIS REGULATION:

            Article 1
            Annex I to Regulation (EC) No 881/2002 is amended in accordance with the Annex to this Regulation.

            Article 2
            This Regulation shall enter into force on the day 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, 13 August 2018.

                  For the Commission,

                  On behalf of the President,

                  Head of the Service for Foreign Policy Instruments

            (1)  OJ L 139, 29.5.2002, p. 9.

            ANNEX
            In Annex I to Regulation (EC) No 881/2002 the following entry is added under the heading ‘Natural persons’:

               ‘ADNAN ABOU WALID AL-SAHRAOUI (alias (a) Lahbib Idrissi ould Sidi Abdi ould Said ould El Bachir, (b) Adnan Abu Walid al-Sahrawi, (c) Abu Walid al Sahrawi, (d) Adnan Abu Walid al-Sahraoui, (e) Adnan Abu Waleed al-Sahrawi, (f) Lehbib Ould Ali Ould Said Ould Joumani). Date of birth: 16.2.1973. Place of birth: Laayoune. Address: (a) Ménaka, Gao Region, Mali. Other information: Former spokesperson of the Mouvement pour l'Unification et le Jihad en Afrique de l'Ouest (MUJAO). Emir of the Al-Mourabitoun group in Mali. Pledged allegiance to Islamic State in Iraq and the Levant (ISIL), listed as Al-Qaida in Iraq. Date of designation referred to in Article 7d(2)(i): 9.8.2018.’


title: Commission Implementing Regulation (EU) 2018/27 of 9 January 2018 conferring protection under Article 99 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council on the name ‘Ribeiras do Morrazo’ (PGI)

text:
               10.1.2018

               EN

               Official Journal of the European Union

               L 5/26

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/27
   of 9 January 2018
   conferring protection under Article 99 of Regulation (EU) No 1308/2013 of the European Parliament and of the Council on the name ‘Ribeiras do Morrazo’ (PGI)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 99 thereof,
   Whereas:

               (1)

               In accordance with Article 97(2) and (3) of Regulation (EU) No 1308/2013, the Commission has examined the application to register the name ‘Ribeiras do Morrazo’ sent by Spain and has published it in the Official Journal of the European Union
                   (2).

               (2)

               No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

               (3)

               In accordance with Article 99 of Regulation (EU) No 1308/2013, the name ‘Ribeiras do Morrazo’ should be protected and entered in the register referred to in Article 104 of that Regulation.

               (4)

               The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The name ‘Ribeiras do Morrazo’ (PGI) is hereby protected.
   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, 9 January 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 347, 20.12.2013, p. 671.

      (2)  OJ C 255, 5.8.2017, p. 15.


title: Commission Implementing Regulation (EU) 2018/26 of 9 January 2018 approving amendments to the specification for a protected designation of origin or a protected geographical indication (‘Montravel’ (PDO))

text:
               10.1.2018

               EN

               Official Journal of the European Union

               L 5/25

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/26
   of 9 January 2018
   approving amendments to the specification for a protected designation of origin or a protected geographical indication (‘Montravel’ (PDO))
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 99 thereof,
   Whereas:

               (1)

               The Commission has examined France's application pursuant to Article 105 of Regulation (EU) No 1308/2013 for the approval of amendments to the specification for the protected designation of origin ‘Montravel’.

               (2)

               The Commission has published the application for the approval of amendments to the specification, as required by Article 97(3) of Regulation (EU) No 1308/2013, in the Official Journal of the European Union
                   (2).

               (3)

               No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

               (4)

               The amendments to the specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013.

               (5)

               The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of Agricultural Markets,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Montravel’ (PDO) are hereby approved.
   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, 9 January 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 347, 20.12.2013, p. 671.

      (2)  OJ C 255, 5.8.2017, p. 10.


title: Council Implementing Regulation (EU) 2018/31 of 10 January 2018 implementing Article 11(1) of Regulation (EU) No 377/2012 concerning restrictive measures directed against certain persons, entities and bodies threatening the peace, security or stability of the Republic of Guinea-Bissau

text:
               11.1.2018

               EN

               Official Journal of the European Union

               L 6/1

         COUNCIL IMPLEMENTING REGULATION (EU) 2018/31
   of 10 January 2018
   implementing Article 11(1) of Regulation (EU) No 377/2012 concerning restrictive measures directed against certain persons, entities and bodies threatening the peace, security or stability of the Republic of Guinea-Bissau
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EU) No 377/2012 of 3 May 2012 concerning restrictive measures directed against certain persons, entities and bodies threatening the peace, security or stability of the Republic of Guinea-Bissau (1), and in particular Article 11(1) thereof,
   Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
   Whereas:

               (1)

               On 3 May 2012, the Council adopted Regulation (EU) No 377/2012.

               (2)

               On 20 December 2017, the United Nations Security Council Committee established pursuant to United Nations Security Council Resolution 2048 (2012) deleted one person from the list of persons subject to restrictive measures.

               (3)

               That person should be deleted from Annex I to Regulation (EU) No 377/2012,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex I to Regulation (EU) No 377/2012 is hereby amended as set out in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the date 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, 10 January 2018.

            For the Council

            The President

         E. KRALEVA

      (1)  OJ L 119, 4.5.2012, p. 1.

      ANNEX
      In Annex I to Regulation (EU) No 377/2012, the entry concerning the person listed below is deleted:

                  11.

                  Sanha CLUSSÉ.


title: Commission Implementing Regulation (EU) 2018/33 of 28 September 2017 laying down implementing technical standards with regard to the standardised presentation format of the statement of fees and its common symbol according to Directive 2014/92/EU of the European Parliament and of the Council (Text with EEA relevance. )

text:
                  11.1.2018

                  EN

                  Official Journal of the European Union

                  L 6/26

            COMMISSION IMPLEMENTING REGULATION (EU) 2018/33
      of 28 September 2017
      laying down implementing technical standards with regard to the standardised presentation format of the statement of fees and its common symbol according to Directive 2014/92/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 2014/92/EU of the European Parliament and of the Council of 23 July 2014 on the comparability of fees related to payment accounts, payment account switching and access to payment accounts with basic features (1), and in particular the second subparagraph of Article 5(4) thereof,
      Whereas:

                  (1)

                  Directive 2014/92/EU requires Member States to ensure that payment service providers provide the consumer, at least annually and free of charge, with a statement of all fees incurred, as well as, where applicable, information regarding the interest rates for services linked to a payment account. Payment service providers are required to use the standardised terms set out in the final list of the most representative services linked to a payment account. The final lists are to be published by Member States, integrating the Union standardised terminology laid down in Commission Delegated Regulation (EU) 2018/32 (2).

                  (2)

                  In order to ensure that the statement of fees achieves the aims of Directive 2014/92/EU and, at the same time, provides the consumer with all relevant information in a way that enhances comparison and transparency, payment service providers should use a standardised template for the statement of fees.

                  (3)

                  As regards the presentation of packages of services linked to a payment account, it needs to be taken into account that there are different kinds of packages offered by payment service providers. The provision of some packages is included in a general fee, such as for maintaining or operating the account, while other packages are charged separately from such general fee and some packages include a certain quantity of services. In order to make it easier for the consumer to understand the content of the different types of packages and their fees, the statement of fees should list the packages separately. In particular, if the packages are charged as part of a general fee, such packages should be displayed together with that fee.

                  (4)

                  Member States are able to require key indicators such as a comprehensive cost indicator to be provided with the statement of fees. Therefore the template for the statement of fees should include a separate table, to be used by those payment service providers which are subject to such conditions.

                  (5)

                  Furthermore, since the statement of fees should be easily produced by payment service providers, there should be clear instructions for payment service providers on how to complete the statement of fees.

                  (6)

                  This Regulation is based on the draft implementing technical standards submitted by the European Supervisory Authority (European Banking Authority) (‘EBA’) to the Commission.

                  (7)

                  The EBA has conducted open public consultations on the draft implementing technical standards on which this Regulation is based, analysed the potential related costs and benefits and requested the opinion of the Banking Stakeholder Group established in accordance with Article 37 of Regulation (EU) No 1093/2010 of the European Parliament and of the Council (3),

            HAS ADOPTED THIS REGULATION:
      Article 1
      Template for the statement of fees and its common symbol
      1.   Payment service providers shall use the template as laid down in the Annex and complete it as set out in Articles 2 to 18.
      2.   Payment service providers shall not modify the template for the statement of fees in completing it other than provided for in this Regulation. In particular, payment service providers shall follow the order of information, headings and sub-headings laid down in the template.
      3.   The statement of fees shall:

                  (a)

                  be presented in A4 portrait format;

                  (b)

                  contain the title ‘Statement of Fees’ at the top of the first page, with the title centred and positioned in the middle between the logo of the payment service provider at the top left-hand side of the document and the common symbol at the top right-hand side of the document;

                  (c)

                  contain the common symbol of the size not larger than 2,5 cm × 2,5 cm and displayed as shown in the template laid down in the Annex;

                  (d)

                  use font type Arial or another font type similar to Arial and font size 11, with exceptions for the title ‘Statement of Fees’, which uses font size 16 in bold type; font size 14 in bold type for the headings, and font size 12 in bold for the sub-headings, unless an increase in the font size or use of braille font type for visually impaired persons is either required under national law or agreed between the consumer and the payment service provider;

                  (e)

                  be produced in black and white, with exception of the logo of the payment service provider and the common symbol which may be presented in colour, as laid down in Article 2;

                  (f)

                  contain the headings in semi-dark grey using the colour pattern with reference number 166,166,166 of the RGB colour model and the sub-headings in light-grey colour using the colour pattern with reference number 191,191,191 of the RGB colour model;

                  (g)

                  have its pages numbered.

            Article 2
      Common symbol and logo of the payment service provider
      1.   Where the common symbol is displayed in colour it shall follow the colour pattern with reference number 0/51/153 (hexadecimal: 003399) of the RGB colour model for the background and colour pattern 255/204/0 (hexadecimal: FFCC00) of the RGB colour model for the symbol.
      2.   The logo of the payment service provider shall be of an equivalent size to the size of the common symbol.
      3.   The logo may only be displayed in colour if the common symbol is also displayed in colour. Where printed in black and white the common symbol shall be clearly readable.
      Article 3
      Name and contact details of the account provider
      1.   Payment service providers shall replace indications between square brackets with the name of the account provider in bold type and left aligned.
      2.   Payment service providers shall replace indications between square brackets with their contact details, such as the geographical address, telephone number, e-mail address, fax number, web address and contact person/point that the payment account holder may use for future correspondence.
      Those contact details shall be displayed left aligned.
      Article 4
      Name and contact details of the payment account holder
      1.   Payment service providers shall replace indications between square brackets with the name of the payment account holder.
      That name shall be displayed in bold type, left aligned.
      2.   Payment service providers shall replace indications between square brackets with the geographical address of the payment account holder.
      That geographical address shall be displayed left aligned and, with the exception of the first letter of each word, in lower cases.
      Article 5
      Account name and identification
      1.   Payment service providers shall display the name of the payment account.
      That name shall be displayed in bold type, left aligned and directly after relevant words.
      2.   Payment service providers shall display details that identify the payment account, such as the Bank Identifier Code (BIC), the International Bank Account Number (IBAN), the national account number and national sort code.
      Those details shall be displayed left aligned.
      Article 6
      Calendar period
      Payment service providers shall display in the row ‘period’, left aligned, the calendar period that is covered by the statement of fees.
      Article 7
      Date
      Payment service providers shall display in the row ‘date’, left aligned, the calendar date when they provide the statement of fees.
      Article 8
      Introductory statement
      The text of the introductory statement specified in the template shall be reproduced as such in the statement of fees, using line spacing 1.15, 0 pt before and 10 pt after the text.
      Article 9
      Summary of fees and interest
      1.   Payment service providers shall display in bold type and right aligned the total amounts of the fees and interests to be included in the four separate tables under ‘Summary of fees and interest’.
      2.   Where interest is not applicable to a specific account, and where the inclusion of such information is enabled or required by national provisions transposing Directive 2014/92/EU, payment service providers shall use the wording ‘interest not applicable’, in lower case, right aligned.
      3.   Where interest is applicable but, for the specific period, it amounts to zero, and where the inclusion of such information is enabled or required by national provisions transposing Directive 2014/92/EU, payment service providers shall indicate this by using ‘0’ in the corresponding table.
      4.   Payment service providers shall display the comprehensive cost indicator summarising the overall annual cost of the payment account in a separate table, where required by national provisions transposing Directive 2014/92/EU. Payment service providers shall delete the table, if those national provisions do not require payment service providers to display the comprehensive cost indicator.
      Article 10
      Detailed statement of fees paid on the account
      1.   Payment service providers shall list in the table headed ‘Detailed statement of fees paid on the account’ all fees incurred in the relevant period for the corresponding services.
      Fees for provision or maintenance of the account shall be listed under sub-heading ‘General account services’.
      2.   Payment service providers shall insert the services in the sub-column ‘Service’, left aligned, in bold type, using line spacing single, 0 pt before and 0 pt after each service.
      3.   Payment service providers shall display in the sub-column ‘Number of times the service was used’ the number of times each service has been used during the relevant period of the statement of fees, right aligned, using the font prescribed in Article 1(3)(d).
      Payment service providers shall leave the sub-column ‘Number of times the service was used’ blank where:

                  (a)

                  a service has been used but the payment service provider did not charge a fee for that service, and

                  (b)

                  the inclusion of such information is enabled or required by national provisions transposing Directive 2014/92/EU.

            4.   Payment service providers shall display in the sub-column ‘Unit fee’ the unit fee structure and cost for each service used, right aligned.
      5.   Payment service providers shall display in the sub-column ‘Number of times the fee was charged’ the number of times each service has been charged during the relevant period of the statement of fees, right aligned. Payment service providers shall indicate this in the corresponding sub-column by using the wording ‘fee not charged’ where:

                  (a)

                  a service has been used but no fee has been charged, and

                  (b)

                  the inclusion of such information is enabled or required by national provisions transposing Directive 2014/92/EU.

            6.   Payment service providers shall display in the sub-column ‘Total’ the resulting total amount of fees paid for using that service during the relevant period, in bold.
      7.   Where a sub-heading does not contain any service, payment service providers shall delete that sub-heading. Payment service providers shall also delete the sub-heading when the payment account holder did not use any services beyond the quantities indicated in the package of services during the relevant period.
      8.   Payment service providers shall display the resulting total amount of fees paid by a payment account holder during the relevant period in the row ‘Total fees paid’, in bold.
      Article 11
      Presentation of types of fees
      1.   Where separate fees are charged in one or more of the following ways, payment services providers shall provide, in the table ‘Detailed statement of fees paid on the account’ in the ‘Service’ column of the respective service on a separate line, a description of each fee-charging instance, channel or condition (‘types of fees’):

                  (a)

                  for different fee-charging instances of the provision of the same service, such as an initial set-up fee and subsequent execution fees for the same service;

                  (b)

                  for different channels through which the same service is requested, used or provided, such as by phone, branch or online;

                  (c)

                  depending on whether a specific condition for the same service is met, such as adherence to a minimum or maximum threshold amount for credit transfers or cash withdrawals.

            The description shall be left aligned. The fees shall be displayed in the ‘Unit fee’ column right aligned.
      2.   Where fees are charged dependent on a combination of several types of fees, such as fees that differ by channel and are then further separated depending on whether a threshold amount is met, payment service providers shall, in addition to applying Article 10(5), right-align the description of each additional type of fee.
      3.   Where the fee has changed during the relevant period, payment service providers shall list the fees applied during each period, by adding new lines to the ‘Unit fee’ column.
      Article 12
      Presentation of packages of services charged as part of fees under the sub-heading ‘General account services’
      1.   Where a package of services linked to a payment account is offered with the account and is charged as part of the fees under the sub-heading ‘General account service’, payment service providers shall include in the table ‘Detailed statement of fees paid on the account’ in the row on ‘Package of services’ the information on the services included in the package in the column ‘Service’ and the number of the times the package was used in the column ‘Number of times the service was used’. In the columns under ‘Fee’, payment service providers shall display the fee charged for the package as a whole, and the number of times the package fee was charged during the relevant period respectively as set out in Article 11(1). The row shall be deleted, if the package of services is charged separately from the fee for general account services.
      2.   Any fee charged for any service exceeding the quantity covered by the package shall be disclosed in the table listing services and fees as referred to in Articles 1 to 11.
      3.   If the number of services in the package is not limited, or where the quantities of services covered by the package have not been exceeded, payment service providers shall delete the statement at the bottom of the row ‘Services beyond these quantities have been charged separately’.
      Article 13
      Presentation of packages of services linked to a payment account charged separately from fees under the sub-heading ‘General account services’
      1.   Where a payment service provider offers a package of services linked to a payment account with the account and that package is charged separately from any fees under the sub-heading ‘General account services’ for general account services as referred to in the table listing services and fees, payment service providers shall include the following information in the table on package of services:

                  (a)

                  in the column on package of services, the brand name, if applicable, or the content the package, by deleting the square brackets;

                  (b)

                  in the ‘Fee’ column, the fee charged for the package as a whole for the period of the statement of fees, right aligned;

                  (c)

                  in the third column, the number of times the package fee was charged during the relevant period.

            Any additional fee charged for any service exceeding the quantity covered by the package fee shall be disclosed in the table on service and fees as referred to in Articles 10 and 11.
      2.   Where the package is charged with regular frequency, the frequency shall be displayed in the ‘Fee’ column and left aligned, with the total annual cost displayed on the line directly underneath the frequency, in bold type and using the wording ‘Total annual cost’.
      3.   Where different packages incur different fees during the relevant period, the information listed in paragraph 1 shall be provided for each package in a separate table.
      4.   Payment service providers shall delete the entire table, including the heading ‘Detail of the fees included in the package of service’, if a package of services is not provided with the account or if the package of services offered with the account is charged as part of the fee for any general account services.
      5.   Where the number of all services in the package is not limited, or where quantities of services covered by the package of services have not been exceeded, payment service providers shall delete the statement at the bottom of the table that reads ‘Services beyond these quantities have been charged separately’.
      Article 14
      Detail of interest paid on the account
      1.   Payment service providers shall display in the table ‘Detail of interest paid on the account’ the interest paid by the payment account holder during the period covered by the statement of fees, where applicable.
      2.   Payment service providers shall display the interest rate in the column ‘Interest rate’ and as a percentage applied on an annual basis. If the interest rate has changed during the relevant period, payment service providers shall list each interest rate that applied during each period on a separate line.
      3.   Payment service providers shall display in the column ‘Interest’ the interest paid by a payment account holder, expressed in the currency of the account, in bold. If the interest rate has changed during the relevant period, payment service providers shall show the interest paid by the payment account holder separately for each of the relevant periods, each on a separate line.
      4.   Payment service providers shall display the resulting total amount of interest paid by the payment account holder during the relevant period, in bold, in row ‘Total interest paid’.
      5.   Where no interest is paid by a payment account holder because no interest is applicable to the account, and where the inclusion of such information is enabled or required by national provisions transposing Directive 2014/92/EU, payment service providers shall indicate it by words ‘interest not applicable’, in lower case, left aligned, in bold, in row ‘Total interest paid’.
      Article 15
      Detail of interest earned on the account
      1.   Payment service providers shall display in the table ‘Detail of interest earned on the account’ the interest earned by the payment account holder during the period covered by the statement of fees, where applicable.
      2.   Payment service providers shall replace ‘Account name’ with the name of the relevant account, in bold.
      3.   Payment service providers shall display the interest rate in the column ‘Interest rate’ and as a percentage applied on an annual basis. If the interest rate changed during the relevant period, payment service providers shall list each interest rate that applied during each period on a separate line.
      4.   Payment service providers shall display in the column ‘Interest’ the interest earned by a payment account holder, expressed in the currency of the account, in bold, in the column ‘Interest’. If the interest rate has changed during the period covered by the statement of fees, payment service providers shall show the interest earned by the payment account holder separately for each of the relevant periods, each on a separate line. Where interest rate is applicable but, for the specific period, it amounts to zero, payment service providers shall display ‘0’ in the column ‘Interest’.
      5.   Where a particular account does not pay the interest because no interest is applicable to the account, payment service providers shall indicate it by words ‘interest not applicable’, in lower case, left aligned, in the column ‘Interest’.
      6.   Payment service providers shall display in the row ‘Total interest earned’ the resulting total amount of interest earned by the payment account holder during the period covered by the statement of fees, in bold.
      7.   Where a particular account does not pay the interest because no interest is applicable to the account, and where the inclusion of such information is enabled or required by national provisions transposing Directive 2014/92/EU, payment service providers shall indicate it by words ‘interest not applicable’, in lower case, left aligned, in bold, in row ‘Total interest earned’.
      Article 16
      Additional information
      1.   Payment service providers shall display in the table ‘Additional information’ any additional information that goes beyond the information covered under Articles 2 to 15 and that is directly related to the services or fees paid or interest charged or earned, or interest rates applied, as referred to in Article 5(2) of Directive 2014/92/EU during the period covered by the statement of fees. The additional information displayed in that table shall include information required by national provisions.
      2.   In completing the table payment service providers shall follow the presentation format as set out in this Regulation, where applicable.
      3.   Payment service providers shall delete this table should they not provide information of the kind specified in paragraph 1.
      Article 17
      Brand names
      Where a brand name is used, the brand name shall follow directly after the name of the service, using the standard font referred to in Article 1(3)(d) and in square brackets.
      Article 18
      Use of electronic means
      1.   Where the statement of fees is provided by electronic means payment service providers may, provided that at the same time the consumer is provided with a copy of the statement of fees in line with the template laid down in the Annex and completed as set out in Articles 2 to 17, modify the template in only the following ways:

                  (a)

                  by way of derogation from point (d) of Article 1(3), increase the font sizes, provided that the proportion of sizes as set out in Article 1(3) is retained;

                  (b)

                  where the dimensions of the electronic tools are such that using several tables and columns would make the statement of fees difficult to read, use a single column or a single table if the order of information, headings and sub-headings are retained;

                  (c)

                  use electronic tools, such as layering and pop-ups, provided that the title of the statement of fees, the common symbol, headings and sub-headings, are displayed prominently and the order of information is retained.

            2.   The use of the electronic tools referred to in point (c) of paragraph 1 shall not be intrusive that it could distract the consumer from the information in the statement of fees. Information provided through layering and pop-ups shall be limited to the information referred to in this Regulation.
      Article 19
      Entry into force
      This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

         This Regulation shall be binding in its entirety and directly applicable in all Member States.
         Done at Brussels, 28 September 2017.

               For the Commission

               The President

            Jean-Claude JUNCKER

         (1)  OJ L 257, 28.8.2014, p. 214.

         (2)  Commission Delegated Regulation (EU) 2018/32 of 28 September 2017 supplementing Directive 2014/92/EU of the European Parliament and of the Council with regard to regulatory technical standards for the Union standardised terminology for the most representative services linked to a payment account (see page 3 of this Official Journal).

         (3)  Regulation (EU) No 1093/2010 of the European Parliament and of the Council of 24 November 2010 establishing a European Supervisory Authority (European Banking Authority), amending Decision No 716/2009/EC and repealing Commission Decision 2009/78/EC (OJ L 331, 15.12.2010, p. 12).

         ANNEX

            Statement of fees template

         Text of image

            Statement of Fees
            [Name of the account provider]
            [Contact details of the account provider]
            [Client name]
            [Contact details]
            Account
            Account identification
            Period
            From to
            Date
            ·
            This document provides you with an overview of all the fees for services linked to your payment account during the period shown above.
            ·
            It also informs you about any interest you may have paid or earned during this time.
            ·
            Information on individual transactions and account balance can be found on your account statements.
            Summary of fees and interest
            Total fees paid (total package of services fees and total fees paid)
            Total interest paid
            Total interest earned
            Comprehensive cost indicator

         Text of image

            Detailed statement of fees paid on the account
            Service
            Fee
            Service
            Number of times the service was used
            Unit fee
            Number of times the fee was charged
            Total
            General account services
            Includes a package of services consisting of:
            Services beyond these quantities have been charged separately
            Payments (excluding cards)
            Cards and cash
            Overdrafts and related services
            Other services
            Total fees paid
            Detail of the fees included in the package of services
            Package of services
            Fee
            Number of times the fee was charged
            ‘Package service’ [brand name, if applicable]
            Includes:
            Services beyond these quantities have been charged separately.
            Detail of interest paid on the account
            Interest rate
            Interest
            Total interest paid

         Text of image

            Detail of interest earned on the account
            Interest rate
            Interest
            ‘Account name’
            Total interest earned
            Additional information