title: Commission Implementing Regulation (EU) 2017/2311 of 13 December 2017 setting the weighted average of maximum mobile termination rates across the Union and repealing Implementing Regulation (EU) 2016/2292 (Text with EEA relevance. )

text:
               14.12.2017

               EN

               Official Journal of the European Union

               L 331/39

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2311
   of 13 December 2017
   setting the weighted average of maximum mobile termination rates across the Union and repealing Implementing Regulation (EU) 2016/2292
   (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 531/2012 of the European Parliament and of the Council of 13 June 2012 on roaming on public mobile communications networks within the Union (1), and in particular Article 6e(2) thereof,
   Whereas:

               (1)

               In accordance with Regulation (EU) No 531/2012, from 15 June 2017 domestic providers should not levy any surcharge in addition to the domestic retail price on roaming customers in any Member State, for any regulated roaming call received, within the limits allowed by fair use policy.

               (2)

               Regulation (EU) No 531/2012 allows domestic providers to apply, after 15 June 2017, a surcharge, in addition to the domestic retail price, for the consumption of regulated retail roaming services in excess of any limit set under a fair use policy.

               (3)

               Regulation (EU) No 531/2012 limits any surcharge applied for receiving regulated roaming calls to the weighted average of maximum mobile termination rates across the Union.

               (4)

               Commission Implementing Regulation (EU) 2016/2292 (2) set out the weighted average of maximum mobile termination rates across the Union to be applied in 2017 on the basis of the values of the data of 1 July 2016.

               (5)

               The Body of European Regulators for Electronic Communications has provided the Commission with updated information gathered from Member States' national regulatory authorities on the maximum level of mobile termination rates they imposed, in accordance with Articles 7 and 16 of Directive 2002/21/EC of the European Parliament and of the Council (3) and Article 13 of Directive 2002/19/EC of the European Parliament and of the Council (4), in each national market for wholesale voice call termination on individual mobile networks; and on the total number of subscribers in the Member States.

               (6)

               Pursuant to Regulation (EU) No 531/2012, the Commission has calculated the weighted average of the maximum mobile termination rates across the Union by: (i) multiplying the maximum mobile termination rate permitted in a given Member State by the total number of subscribers in that Member State; (ii) summing this product over all Member States; and (iii) dividing the total obtained by the total number of subscribers in all Member States, on the basis of the values of the data of 1 July 2017. For non-euro Member States, the relevant exchange rate is the average for the second quarter of 2017 obtained from the European Central Bank's database.

               (7)

               It is therefore necessary to update the value of the weighted average of maximum mobile termination rates across the Union laid down in Implementing Regulation (EU) 2016/2292.

               (8)

               Implementing Regulation (EU) 2016/2292 should therefore be repealed.

               (9)

               Pursuant to Regulation (EU) No 531/2012 the Commission is to review the weighted average of maximum mobile termination rates across the Union annually.

               (10)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The weighted average of maximum mobile termination rates across the Union is set at EUR 0,0091 per minute.
   Article 2
   Implementing Regulation (EU) 2016/2292 is repealed.
   Article 3
   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 December 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 172, 30.6.2012, p. 10.

      (2)  Commission Implementing Regulation (EU) 2016/2292 of 16 December 2016 setting out the weighted average of maximum mobile termination rates across the Union and repealing Implementing Regulation (EU) 2015/2352 (OJ L 344, 17.12.2016, p. 77).

      (3)  Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive) (OJ L 108, 24.4.2002, p. 33).

      (4)  Directive 2002/19/EC of the European Parliament and of the Council of 7 March 2002 on access to, and interconnection of, electronic communications networks and associated facilities (Access Directive) (OJ L 108, 24.4.2002, p. 7).


title: Commission Implementing Regulation (EU) 2017/2313 of 13 December 2017 setting out the format specifications of the plant passport for movement within the Union territory and the plant passport for introduction into, and movement within, a protected zone

text:
               14.12.2017

               EN

               Official Journal of the European Union

               L 331/44

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2313
   of 13 December 2017
   setting out the format specifications of the plant passport for movement within the Union territory and the plant passport for introduction into, and movement within, a protected zone
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (1), and in particular Article 83(7) thereof,
   Whereas:

               (1)

               Article 83(7) of Regulation (EU) 2016/2031 empowers the Commission to adopt the format specifications of plant passports for movement within the Union territory and of plant passports for introduction into, and movement within, a protected zone. In order to ensure easy visibility and clear legibility, it is important for plant passports to have standardised formats. This also ensures that plant passports are clearly distinguishable from any other information or label.

               (2)

               Due to the differences in size and characteristics of plants, plant products or other objects for which a plant passport is required, a certain degree of flexibility should be ensured as regards format specifications of plant passports. Therefore, within each category of plant passports set out in Parts A to D of the Annex, various alternative models should be available which allow for taking into account the said differences of plants, plant products or other objects for which a plant passport is required. Moreover, those models should not specifically provide for the size of the plant passports, the use of a border line, the proportion of the size of their elements, and the fonts used therein.

               (3)

               The elements of the plant passport should be arranged within a rectangular or square shape, and should be clearly separated from any other written or pictorial matter by a border line or otherwise. As experience has shown, this is important to enhance the visibility of plant passports and their distinctiveness from any other information or label.

               (4)

               For reasons of legal certainty, this Regulation should apply from the same date as Regulation (EU) 2016/2031.

               (5)

               Many plants, plant products and other objects for which plant passports will be issued in accordance with Commission Directive 92/105/EEC (2) before the date of application of this Regulation will still be on the market or moved after that date. As no health concern requires the immediate change of the format specifications, plant passports issued before 14 December 2019 should remain valid until 14 December 2023.

               (6)

               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
   Models for plant passports
   1.   Plant passports for movement within the Union territory shall comply with one of the models provided for in Part A of the Annex.
   2.   Plant passports for introduction into, and movement within, a protected zone, shall comply with one of the models provided for in Part B of the Annex.
   3.   Plant passports for movement within the Union territory, combined with a certification label pursuant to the second subparagraph of Article 83(5) of Regulation (EU) 2016/2031, shall comply with one of the models provided for in Part C of the Annex.
   4.   Plant passports for introduction into, and movement within, a protected zone, combined with a certification label pursuant to the third subparagraph of Article 83(5) of Regulation (EU) 2016/2031, shall comply with one of the models provided for in Part D of the Annex.
   Article 2
   Requirements for the elements of the plant passports
   The elements of the plant passport, as set out in Annex VII to Regulation (EU) 2016/2031, shall be arranged within a rectangular or square shape, and shall be legible without the use of a visual aid.
   They shall be contained within a border line, or otherwise clearly separated from any written or pictorial matter, so as to be easily visible and clearly distinguishable.
   Article 3
   Entry into force
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   Date of application
   This Regulation shall apply from 14 December 2019.
   Plant passports issued before 14 December 2019, in accordance with Directive 92/105/EEC, shall remain valid until 14 December 2023.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 13 December 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 317, 23.11.2016, p. 4.

      (2)  Commission Directive 92/105/EEC of 3 December 1992 establishing a degree of standardization for plant passports to be used for the movement of certain plants, plant products or other objects within the Community, and establishing the detailed procedures related to the issuing of such plant passports and the conditions and detailed procedures for their replacement (OJ L 4, 8.1.1993, p. 22).

      ANNEX
      Technical specification: The size of the plant passports, the use of a border line, the proportions of the size of their elements, and the fonts used in the models are only examples.
      The flag of the Union may be printed in colour, or in black and white, either with white stars on black background, or vice versa.
      Legend

                  1.

                  The words ‘Plant Passport’ or ‘Plant Passport — PZ’ in English and, if relevant, in one other official language of the Union, to be separated by a slash.

                  2.

                  The botanical name(s) of the plant(s) species or taxon(s) concerned, in the case of plants and plant products, or, where appropriate, the name of the object concerned, and, optionally, the name of the variety.

                  3.

                  The two-letter code indicated in norm ISO 3166-1-alpha-2 (1), referred to in point (a) of Article 67 of Regulation (EU) 2016/2031, for the Member State in which the professional operator issuing the plant passport is registered.

                  4.

                  The alphabetical, numerical or alphanumerical national registration number of the professional operator concerned.

                  5.

                  Where applicable, the traceability code of the plant, plant product or the other object concerned.

                  6.

                  Where applicable, the unique barcode, QR-code, hologram, chip or other data carrier, supplementing the traceability code.

                  7.

                  Where applicable, the two-letter code indicated in norm ISO 3166-1-alpha-2, referred to in point (a) of Article 67 of Regulation (EU) 2016/2031, of the Member State(s) of origin.

                  8.

                  Where applicable, the name(s) of the third country/countries of origin or its/their two-letter code indicated in norm ISO 3166-1-alpha-2.

                  9.

                  Scientific name(s) of protected zone quarantine pest(s) or, alternatively, the codes specifically attributed to those pests, referred to in Article 32(3) of Regulation (EU) 2016/2031.

                  10.

                  Information required for an official label for seeds or other propagative material referred to respectively in Article 10(1) of Council Directive 66/401/EEC (2), Article 10(1) of Council Directive 66/402/EEC (3), Article 10(1) of Council Directive 68/193/EEC (4), Article 12 of Council Directive 2002/54/EC (5), Article 28(1) of Council Directive 2002/55/EC (6), Article 13(1) of Council Directive 2002/56/EC (7), Article 12(1) of Council Directive 2002/57/EC (8), or the label for pre-basic, basic or certified material as referred to in point (b) of Article 9(1) of Council Directive 2008/90/EC (9).

         PART A

         Models for the plant passports for the movement within the Union territory, referred to in Article 1(1)

         PART B

         Models for the plant passports for the introduction into, and movement within, a protected zone, referred to in Article 1(2)

         PART C

         Models for the plant passports for the movement within the Union territory, combined with a certification label, referred to in Article 1(3)

         PART D

         Models for the plant passports, for the introduction into, and movement within, a protected zone, combined with a certification label, referred to in Article 1(4)

         (1)  ISO 3166-1:2006, Codes for the representation of names of countries and their subdivisions — Part 1: Country codes. International Organisation for Standardisation, Geneva.

         (2)  Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (OJ 125, 11.7.1966, p. 2298/66).

         (3)  Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (OJ 125, 11.7.1966, p. 2309/66).

         (4)  Council Directive 68/193/EEC of 9 April 1968 on the marketing of material for the vegetative propagation of the vine (OJ L 93, 17.4.1968, p. 15).

         (5)  Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed (OJ L 193, 20.7.2002, p. 2).

         (6)  Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (OJ L 193, 20.7.2002, p. 33).

         (7)  Council Directive 2002/56/EC of 13 June 2002 on the marketing of seed potatoes (OJ L 193, 20.7.2002, p. 60).

         (8)  Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants (OJ L 193, 20.7.2002, p. 74).

         (9)  Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit plant propagating material and fruit plants intended for fruit production (OJ L 267, 8.10.2008, p. 8).


title: Commission Implementing Regulation (EU) 2017/2324 of 12 December 2017 renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance. )

text:
               15.12.2017

               EN

               Official Journal of the European Union

               L 333/10

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2324
   of 12 December 2017
   renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) thereof,
   Whereas:

               (1)

               Commission Directive 2001/99/EC (2) included glyphosate as an active substance in Annex I to Council Directive 91/414/EEC (3).

               (2)

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

               (3)

               The approval of the active substance glyphosate, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 15 December 2017.

               (4)

               An application for the renewal of the inclusion of the active substance glyphosate in Annex I to Directive 91/414/EEC was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (5) within the time period provided for in that Article.

               (5)

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

               (6)

               The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 20 December 2013.

               (7)

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

               (8)

               Following the findings of the International Agency for Research on Cancer published on 20 March 2015 as regards the carcinogenic potential of glyphosate, on 29 April 2015 the Commission mandated the Authority to review the underlying information and to include those findings in its conclusion by 13 August 2015.

               (9)

               To allow for an appropriate evaluation of the information (6) from the International Agency for Research on Cancer and of the extraordinarily high number of comments received from Member States and the public, the Commission extended the deadline for the submission of the Authority's conclusion to 30 October 2015.

               (10)

               On 30 October 2015 (7), the Authority communicated to the Commission its conclusion on whether glyphosate can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft review report for glyphosate to the Standing Committee on Plants, Animals, Food and Feed on 28 January 2016.

               (11)

               The applicant was given the possibility to submit comments on the draft review report.

               (12)

               The discussions in the Standing Committee on Plants, Animals, Food and Feed on 18 and 19 May 2016 showed that in the specific situation of glyphosate a number of Member States, in their role as risk managers, considered that it was appropriate to have an opinion of the Committee for Risk Assessment of the European Chemicals Agency (hereinafter ‘the Agency’) on the harmonised classification as regards carcinogenicity of glyphosate, before taking a decision on a renewal of the approval because such an opinion could be relevant for the approval based on the criteria set out in Regulation (EC) No 1107/2009.

               (13)

               The possible renewal of the approval of glyphosate was also extensively discussed outside of the Standing Committee on Plants, Animals, Food and Feed. On 13 April 2016 (8) and on 24 October 2017 (9), the European Parliament adopted Resolutions on the different draft Commission Implementing Regulations renewing the approval of the active substance glyphosate, and on 6 October 2017 the European Commission officially received a successful European Citizens' Initiative (ECI) (10), referring specifically to glyphosate in one of its three aims, with validated signatures from at least one million European citizens in at least seven Member States.

               (14)

               As an opinion of the Committee for Risk Assessment of the Agency on the harmonised classification as regards carcinogenicity of glyphosate was deemed necessary, on 17 March 2016, the rapporteur Member State submitted a dossier in accordance with Article 37 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council (11), including for the hazard class on carcinogenicity. In view of the time required to assess such a dossier, the approval period of the active substance was extended until 6 months from the date of receipt of the opinion of the Committee for Risk Assessment of the Agency by the Commission but however until 31 December 2017 at the latest by Commission Implementing Regulation (EU) 2016/1056 (12). In the meantime, the conditions of approval of the active substance were amended in the light of new scientific and technical knowledge by Commission Implementing Regulation (EU) 2016/1313 (13).

               (15)

               The Committee for Risk Assessment of the Agency adopted its opinion (14) on 15 March 2017 and forwarded it to the Commission on 15 June 2017. The Commission published a Notice (15) confirming the date of its receipt in the Official Journal of the European Union on 28 June 2017. In its opinion, the Committee for Risk Assessment of the Agency concluded by consensus that on the basis of the information currently available, no hazard classification for carcinogenicity is justified for glyphosate.

               (16)

               In its conclusion of October 2015, the Authority identified a data gap to rule out potential endocrine activity observed in one study. Pertinent data became available too late to be included in the peer review. On 27 September 2016 the Commission asked the Authority to assess that additional information. On 7 September 2017 (16) the Authority communicated to the Commission its conclusion on the potential endocrine disrupting properties of glyphosate. In its conclusion, the Authority confirmed that the data gap had been adequately addressed as the weight of evidence indicates that glyphosate does not have endocrine disrupting properties through oestrogen, androgen, thyroid or steroidogenesis mode of action based on a comprehensive database available in the toxicology area. The available ecotoxicology studies did not contradict this conclusion.

               (17)

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

               (18)

               It is therefore appropriate to renew the approval of glyphosate.

               (19)

               While a large amount of information on the active substance glyphosate already exists and has been assessed leading to the conclusion that the approval of the active substance glyphosate should be renewed, additional information on glyphosate is being published at an exceptionally high rate compared to other active substances. Therefore possibilities of rapid future developments in science and technology should be taken into account when deciding on the length of the approval period of glyphosate, also bearing in mind the fact that glyphosate is one of the most widely used herbicides in the Union.

               (20)

               In light of these specificities and other legitimate factors referred to in the recitals above and bearing in mind the need to ensure a level of safety and protection consistent with the high level of protection that is sought within the Union, from a risk management perspective it is appropriate to provide for a renewal of the approval of glyphosate for a period of five years ensuring a priority re-assessment of glyphosate over other active substances.

               (21)

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

               (22)

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

               (23)

               Taking into account that the current approval of glyphosate expires on 15 December 2017, this Regulation should enter into force as soon as possible.

               (24)

               This Regulation should apply from the day after the date of expiry of the approval of the active substance glyphosate as referred to in recital 3.

               (25)

               The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The measures provided for in this Regulation are in accordance with the opinion of the appeal committee,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Renewal of the approval of active substance
   The approval of the active substance glyphosate, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.
   Article 2
   Amendments to Implementing Regulation (EU) No 540/2011
   The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
   Article 3
   Entry into force and date of application
   This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
   It shall apply from 16 December 2017.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Strasbourg, 12 December 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Commission Directive 2001/99/EC of 20 November 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include glyphosate and thifensulfuron-methyl as active substances (OJ L 304, 21.11.2001, p. 14).

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

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

      (5)  Commission Regulation (EU) No 1141/2010 of 7 December 2010 laying down the procedure for the renewal of the inclusion of a second group of active substances in Annex I to Council Directive 91/414/EEC and establishing the list of those substances (OJ L 322, 8.12.2010, p. 10).

      (6)  IARC Monographs on the Evaluation of Carcinogenic Risks to Humans, Volume 112 (2015). Available online: www.iarc.fr

      (7)  EFSA (European Food Safety Authority), 2015. Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate. EFSA Journal 2015;13(11):4302, 107 pp. doi:10.2903/j.efsa.2015.4302 Available online: www.efsa.europa.eu

      (8)  European Parliament resolution of 13 April 2016 on the draft Commission implementing regulation renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (D044281/01 — 2016/2624(RSP)). Available online: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P8-TA-2016-0119&language=EN&ring=B8-2016-0439

      (9)  European Parliament resolution of 24 October 2017 on the draft Commission implementing regulation renewing the approval of the active substance glyphosate in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Implementing Regulation (EU) No 540/2011 (D053565-01 — 2017/2904(RSP). Available online: http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P8-TA-2017-0395&language=EN&ring=B8-2017-0567

      (10)  Commission registration number: ECI(2017)000002, available online: http://ec.europa.eu/citizens-initiative/public/initiatives/successful/details/2017/000002?lg=en.

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

      (12)  Commission Implementing Regulation (EU) 2016/1056 of 29 June 2016 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval period of the active substance glyphosate (OJ L 173, 30.6.2016, p. 52).

      (13)  Commission Implementing Regulation (EU) 2016/1313 of 1 August 2016 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance glyphosate (OJ L 208, 2.8.2016, p. 1).

      (14)  European Chemicals Agency (ECHA) (2017). Opinion of the Committee for Risk Assessment proposing harmonised classification and labelling of glyphosate (ISO); N-(phosphonomethyl)glycine (EC Number: 213-997-4; CAS Number: 1071-83-6).

      (15)  Commission Notice on the date of receipt of the opinion proposing harmonised classification and labelling at EU level of glyphosate of the Committee for Risk Assessment of the European Chemicals Agency (OJ C 204, 28.6.2017, p. 5).

      (16)  EFSA (European Food Safety Authority), 2017. Conclusion on the peer review of the pesticide risk assessment of the potential endocrine disrupting properties of glyphosate. EFSA Journal 2017;15(9):4979, 20 pp. https://doi.org/10.2903/j.efsa.2017.4979.

      ANNEX I

                  Common Name,
                  Identification Numbers

                  IUPAC Name

                  Purity (1)

                  Date of approval

                  Expiration of approval

                  Specific provisions

                  Glyphosate
                  CAS No 1071-83-6
                  CIPAC No 284

                  N-(phosphonomethyl)glycine

                  ≥ 950 g/kg
                  Impurities:
                  Formaldehyde, less than 1 g/kg

                     N-Nitroso-glyphosate, less than 1 mg/kg

                  16 December 2017

                  15 December 2022

                  Only uses as herbicide may be authorised.
                  For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on glyphosate, and in particular Appendices I and II thereof, shall be taken into account.
                  In this overall assessment Member States shall pay particular attention to:

                              —

                              the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses,

                              —

                              the protection of operators and amateur users,

                              —

                              the risk to terrestrial vertebrates and non-target terrestrial plants,

                              —

                              the risk to diversity and abundance of non-target terrestrial arthropods and vertebrates via trophic interactions,

                              —

                              compliance of pre-harvest uses with good agricultural practices.

                        Conditions of use shall include risk mitigation measures, where appropriate.
                  Member States shall ensure that use of plant protection products containing glyphosate is minimised in the specific areas listed in Article 12(a) of Directive 2009/128/EC.
                  Member States shall ensure equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicological studies.
                  Member States shall ensure that plant protection products containing glyphosate do not contain the co-formulant POE-tallowamine (CAS No 61791-26-2).

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

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

                  (1)

                  in Part A, entry 25 on glyphosate is deleted;

                  (2)

                  in Part B, the following entry is added:

                              Common Name,
                              Identification Numbers

                              IUPAC Name

                              Purity (1)

                              Date of approval

                              Expiration of approval

                              Specific provisions

                              ‘118

                              Glyphosate
                              CAS No 1071-83-6
                              CIPAC No 284

                              N-(phosphonomethyl)glycine

                              ≥ 950 g/kg
                              Impurities:
                              Formaldehyde, less than 1 g/kg

                                 N-Nitroso-glyphosate, less than 1 mg/kg

                              16 December 2017

                              15 December 2022

                              Only uses as herbicide may be authorised.
                              For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on glyphosate, and in particular Appendices I and II thereof, shall be taken into account.
                              In this overall assessment Member States shall pay particular attention to:

                                          —

                                          the protection of the groundwater in vulnerable areas, in particular with respect to non-crop uses,

                                          —

                                          the protection of operators and amateur users,

                                          —

                                          the risk to terrestrial vertebrates and non-target terrestrial plants,

                                          —

                                          the risk to diversity and abundance of non-target terrestrial arthropods and vertebrates via trophic interactions,

                                          —

                                          compliance of pre-harvest uses with good agricultural practices.

                                    Conditions of use shall include risk mitigation measures, where appropriate.
                              Member States shall ensure that use of plant protection products containing glyphosate is minimised in the specific areas listed in Article 12(a) of Directive 2009/128/EC.
                              Member States shall ensure equivalence between the specifications of the technical material, as commercially manufactured, and those of the test material used in the toxicological studies.
                              Member States shall ensure that plant protection products containing glyphosate do not contain the co-formulant POE-tallowamine (CAS No 61791-26-2).

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


title: Commission Implementing Regulation (EU) 2017/2330 of 14 December 2017 concerning the authorisation of Iron(II) carbonate, Iron(III) chloride hexahydrate, Iron(II) sulphate monohydrate, Iron(II) sulphate heptahydrate, Iron(II) fumarate, Iron(II) chelate of amino acids hydrate, Iron(II) chelate of protein hydrolysates and Iron(II) chelate of glycine hydrate as feed additives for all animal species and of Iron dextran as feed additive for piglets and amending Regulations (EC) No 1334/2003 and (EC) No 479/2006 (Text with EEA relevance. )

text:
               15.12.2017

               EN

               Official Journal of the European Union

               L 333/41

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2330
   of 14 December 2017
   concerning the authorisation of Iron(II) carbonate, Iron(III) chloride hexahydrate, Iron(II) sulphate monohydrate, Iron(II) sulphate heptahydrate, Iron(II) fumarate, Iron(II) chelate of amino acids hydrate, Iron(II) chelate of protein hydrolysates and Iron(II) chelate of glycine hydrate as feed additives for all animal species and of Iron dextran as feed additive for piglets and amending Regulations (EC) No 1334/2003 and (EC) No 479/2006
   (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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
   Whereas:

               (1)

               Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

               (2)

               The iron compounds Ferric chloride hexahydrate, Ferric oxide, Ferrous carbonate, Ferrous chelate of amino acids hydrate, Ferrous chelate of glycine hydrate, Ferrous fumarate, Ferrous sulphate heptahydrate and Ferrous sulphate monohydrate were authorised without a time limit by Commission Regulation (EC) No 1334/2003 (3) and Commission Regulation (EC) No 479/2006 (4) in accordance with Directive 70/524/EEC. Those substances were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

               (3)

               In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, applications were submitted for the re-evaluation of Ferric chloride hexahydrate, Ferric oxide, Ferrous carbonate, Ferrous chelate of amino acids hydrate, Ferrous chelate of glycine hydrate, Ferrous fumarate, Ferrous sulphate heptahydrate and Ferrous sulphate monohydrate as feed additives for all animal species. Additionally, in accordance with Article 7 of that Regulation, an application was submitted for Iron dextran as feed additive for piglets. The applicants requested that those additives be classified in the additive category ‘nutritional additives’. The applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

               (4)

               Due to scientific considerations, the European Food Safety Authority (‘the Authority’) recommended in its opinions of 19 June 2013 (5), 30 January 2014 (6), 5 March 2014 (7), 28 April 2014 (8) and 27 January 2016 (9) to rename Ferric as Iron(III) and Ferrous as Iron(II), in order to avoid potential misunderstandings. The Authority also recommended splitting Iron(II) chelate of amino acids into the following two groups, in view of its chemical characteristics: Iron(II) chelate of amino acids hydrate and Iron(II) chelate of protein hydrolysates.

               (5)

               The Authority concluded that, under the proposed conditions of use, Iron(II) carbonate, Iron(III) chloride hexahydrate, Iron(II) sulphate monohydrate, Iron(II) sulphate heptahydrate, Iron(II) fumarate, Iron(II) chelate of amino acids hydrate, Iron(II) chelate of protein hydrolysates and Iron(II) chelate of glycine hydrate do not have anadverse effect on animal health, consumer safety and the environment. Considering the capacities to be respiratory, eye and skin irritants due to the presence of Nickel in each iron (II) and iron (III) compound, appropriate protective measures should be taken with respect to the handling of the additives concerned and premixtures containing them, in order to avoid that safety concerns for the users would arise.

               (6)

               In its opinions of 24 January 2017 (10), the Authority concluded that, under the proposed conditions of use, Iron dextran does not have an adverse effect on animal health, consumer safety and the environment, and that no safety concerns for users would arise provided that appropriate protective measures are taken.

               (7)

               The Authority further concluded that Iron(II) carbonate, Iron(III) chloride hexahydrate, Iron(II) sulphate monohydrate, Iron(II) sulphate heptahydrate, Iron(II) fumarate, Iron(II) chelate of amino acids hydrate, Iron(II) chelate of protein hydrolysates, Iron(II) chelate of glycine hydrate and Iron dextran are effective sources of iron; however, the bioavailability of Iron(II) carbonate varies significantly and is considered to be lower than that for Iron(II) sulphate. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

               (8)

               The assessment of Iron(II) carbonate, Iron(III) chloride hexahydrate, Iron(II) sulphate monohydrate, Iron(II) sulphate heptahydrate, Iron(II) fumarate, Iron(II) chelate of amino acids hydrate, Iron(II) chelate of protein hydrolysates and Iron(II) chelate of glycine hydrate as feed additives for all animal species and of Iron dextran for piglets shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied, except for water for drinking. Accordingly, the use of these substances should be authorised as specified in the Annex to this Regulation and their use via water for drinking should be prohibited.

               (9)

               As a result of the granting new authorisations for ‘Ferric chloride hexahydrate’, ‘Ferrous carbonate’, ‘Ferrous chelate of amino acids hydrate’, ‘Ferrous fumarate’, ‘Ferrous sulphate heptahydrate’, ‘Ferrous sulphate monohydrate’ and ‘Ferrous chelate of glycine, hydrate’ by this Regulation and of the denial of the authorisation for ‘Ferric oxide’, the entries of these substances in Regulations (EC) No 479/2006 and (EC) No 1334/2003 should be deleted.

               (10)

               As the Authority could not conclude in its opinions of 24 May 2016 (11) on the safety of ferric oxide for the target species, the additive and feed containing it should be withdrawn from the market as soon as possible. For practical reasons, however, a limited transitional period should be allowed for the withdrawal from the market of the products concerned in order to enable operators to comply properly with the withdrawal obligation.

               (11)

               Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for Ferric chloride hexahydrate, Ferrous carbonate, Ferrous chelate of amino acids hydrate, Ferrous chelate of glycine hydrate, Ferrous fumarate, Ferrous sulphate heptahydrate and Ferrous sulphate monohydrate as authorised by Regulation (EC) No 1334/2003 and Regulation (EC) No 479/2006, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

               (12)

               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
   Authorisation
   The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, are authorised as feed additives in animal nutrition, subject to the conditions laid down in that Annex.
   Article 2
   Special conditions of use
   The authorised substances specified in the Annex as additives belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’ shall not be used in water for drinking.
   Article 3
   Denial
   The authorisation for ferric oxide is hereby denied and the substance shall no longer be used as nutritional feed additive.
   Article 4
   Amendment to Regulation (EC) No 1334/2003
   In the Annex to Regulation (EC) No 1334/2003, from the entry E1 on the element Iron-Fe the following additives, their chemical formulas and descriptions are deleted: ‘Ferric chloride hexahydrate’, ‘Ferrous carbonate’, ‘Ferrous chelate of amino acids hydrate’, ‘Ferrous fumarate’, ‘Ferrous sulphate heptahydrate’, ‘Ferrous sulphate monohydrate’ and ‘Ferric oxide’.
   Article 5
   Amendment to Regulation (EC) No 479/2006
   In the Annex to Regulation (EC) No 479/2006, the entry E1 on the additive ‘Ferrous chelate of glycine, hydrate’ is deleted.
   Article 6
   Transitional measures
   1.   The substances ‘Ferric chloride hexahydrate’, ‘Ferrous carbonate’, ‘Ferrous chelate of amino acids hydrate’, ‘Ferrous chelate of glycine hydrate’, ‘Ferrous fumarate’, ‘Ferrous sulphate heptahydrate’, ‘Ferric oxide’ and ‘Ferrous sulphate monohydrate’ as authorised by Commission Regulation (EC) No 1334/2003 and Commission Regulation (EC) No 479/2006, and premixtures containing those substances, which are produced and labelled before 4 July 2018 in accordance with the rules applicable before 4 January 2018 may continue to be placed on the market and used until the existing stocks are exhausted.
   2.   Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 4 January 2019 in accordance with the rules applicable before 4 January 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
   3.   Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 4 January 2020 in accordance with the rules applicable before 4 January 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
   Article 7
   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, 14 December 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 268, 18.10.2003, p. 29.

      (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feeding-stuffs (OJ L 270, 14.12.1970, p. 1).

      (3)  Commission Regulation (EC) No 1334/2003 of 25 July 2003 amending the conditions for authorisation of a number of additives in feedingstuffs belonging to the group of trace elements (OJ L 187, 26.7.2003, p. 11).

      (4)  Commission Regulation (EC) No 479/2006 of 23 March 2006 as regards the authorisation of certain additives belonging to the group compounds of trace elements (OJ L 86, 24.3.2006, p. 4).

      (5)  EFSA Journal 2013;11(7):3287.

      (6)  EFSA Journal 2014;12(2):3566.

      (7)  EFSA Journal 2014;12(3):3607.

      (8)  EFSA Journal 2015;13(5):4109.

      (9)  EFSA Journal 2016;14(2):4396.

      (10)  EFSA Journal 2017;15(2):4701.

      (11)  EFSA Journal 2016;14(6):4508.


title: Commission Implementing Regulation (EU) 2017/2325 of 14 December 2017 concerning the authorisation of preparations of lecithins liquid, lecithins hydrolysed and lecithins de-oiled as feed additives for all animal species and amending Implementing Regulation (EU) 2017/1007 (Text with EEA relevance. )

text:
                  15.12.2017

                  EN

                  Official Journal of the European Union

                  L 333/17

            COMMISSION IMPLEMENTING REGULATION (EU) 2017/2325
      of 14 December 2017
      concerning the authorisation of preparations of lecithins liquid, lecithins hydrolysed and lecithins de-oiled as feed additives for all animal species and amending Implementing Regulation (EU) 2017/1007
      (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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
      Whereas:

                  (1)

                  Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

                  (2)

                  Lecithins were authorised without a time limit in accordance with Directive 70/524/EEC as feed additive for all animal species. These additives were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1)(b) of Regulation (EC) No 1831/2003.

                  (3)

                  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 an application was submitted for the re-evaluation of preparations of lecithins as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘technological additives’ and in the functional group ‘emulsifiers’. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                  (4)

                  The European Food Safety Authority (‘the Authority’) concluded in its opinion of 13 July 2016 (3) that, under the proposed conditions of use, the preparations of lecithins, lecithins hydrolysed and lecithins de-oiled do not have an adverse effect on animal health, human health or the environment. The Authority also concluded that the preparations are considered efficacious for use in feed as emulsifiers. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                  (5)

                  The assessment of lecithins liquid, lecithins hydrolysed and lecithins de-oiled shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those preparations should be authorised as specified in the Annex I to this Regulation.

                  (6)

                  It is considered appropriate to harmonise the characteristics of the lecithins, lecithins liquid, lecithins hydrolysed and lecithins de-oiled and the conditions of use to avoid the distortion of the market, Commission Implementing Regulation (EU) 2017/1007 (4) should be amended accordingly.

                  (7)

                  Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

                  (8)

                  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
      Authorisation
      The additives specified in Annex I belonging to the additive category ‘technological additives’ and to the functional group ‘emulsifiers’, are authorised as additive in animal nutrition, subject to the conditions laid down in that Annex.
      Article 2
      Amendment to Implementing Regulation (EU) 2017/1007
      The Annex to Implementing Regulation (EU) 2017/1007 is replaced by the text in Annex II to this Regulation.
      Article 3
      Transitional measures
      1.   The additives specified in Annex I and premixtures containing those additives which are produced and labelled before 4 July 2018 in accordance with the rules applicable before 4 January 2018 may continue to be placed on the market and used until the existing stocks are exhausted.
      2.   Compound feed and feed materials containing the additives as specified in Annex I which are produced and labelled before 4 January 2019 in accordance with the rules applicable before 4 January 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
      3.   Compound feed and feed materials containing the additives as specified in Annex I which are produced and labelled before 4 January 2020 in accordance with the rules applicable before 4 January 2018 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
      Article 4
      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, 14 December 2017.

               For the Commission

               The President

            Jean-Claude JUNCKER

         (1)  OJ L 268, 18.10.2003, p. 29.

         (2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

         (3)  EFSA Journal 2016;14(8):4561.

         (4)  Commission Implementing Regulation (EU) 2017/1007 of 15 June 2017 concerning the authorisation of a preparation of lecithins as feed additive for all animal species (OJ L 153, 16.6.2017, p. 13).

         ANNEX I

                     Identification number of the additive

                     Name of the holder of authorisation

                     Additive

                     Composition, chemical formula, description, analytical method

                     Species or category of animal

                     Maximum age

                     Minimum content

                     Maximum content

                     Other provisions

                     End of period of authorisation

                     mg of lecithins/kg of complete feedingstuff with a moisture content of 12 %

                        Category of technological additives. Functional group: emulsifiers

                     1c322i

                     —

                     lecithins liquid

                        Additive composition

                     Preparation of lecithins:
                     phospholipids ≥ 48 %,
                     Moisture ≤ 1 %
                     Liquid form

                        Characterisation of the active substance

                     Liquid lecithins (CAS No 8002-43-5) extracted from rapeseeds, sunflower and/or soybean

                        Analytical method
                         (1)

                     For the characterisation of feed additive:
                     Commission Regulation (EU) No 231/2012 (2) and the corresponding tests in the FAO JECFA monograph ‘Lecithin’ (3)
                         (4)

                     All animal species

                     —

                     —

                     —

                     4 January 2028

                     1c322ii

                     hydrolysed lecithins

                        Additive composition

                     preparation of hydrolysed lecithins:
                     phospholipids ≥ 44 %,
                     Moisture ≤ 1 %
                     Liquid form

                        Characterisation of the active substance

                     Liquid hydrolysed lecithins (CAS No 8002-43-5) extracted from sunflowers and/or soybeans

                        Analytical method
                         (1)

                     For the characterisation of feed additive:
                     Commission Regulation (EU) No 231/2012 (2) and the corresponding tests in the FAO JECFA monograph ‘Lecithin’ (3)
                         (4)

                     All animal species

                     4 January 2028

                     1c322iii

                     —

                     Lecithins de-oiled

                        Additive composition

                     Preparation of de-oiled lecithins having a minimum of: phospholipids ≥ 75 %,
                     Moisture ≤ 2 %
                     Solid form

                        Characterisation of the active substance

                     Solid de-oiled lecithins (CAS No 8002-43-5) extracted from sunflowers and/or soybeans and defatted by solvent extraction

                        Analytical method
                         (1)

                     For the characterisation of feed additive:
                     Commission Regulation (EU) No 231/2012 (2) and the corresponding tests in the FAO JECFA monograph ‘Lecithin’ (3)
                         (4)

                     All animal species

                     —

                     —

                     —

                     4 January 2028

            (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

            (2)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).

            (3)  FAO JECFA Combined Compendium of Food Additive Specifications, ‘Lecithin’, Monograph No 4 (2007), http://www.fao.org/ag/agn/jecfa-additives/specs/monograph4/additive-250-m4.pdf

            (4)  FAO JECFA Combined Compendium for Food Additive Specifications — Analytical methods, test procedures and laboratory solutions used by and referenced in the food additive specifications, Vol. 4, http://www.fao.org/docrep/009/a0691e/a0691e00.htm

         ANNEX II
         ‘
               ANNEX

                           Identification number of the additive

                           Name of the holder of authorisation

                           Additive

                           Composition, chemical formula, description, analytical method

                           Species or category of animal

                           Maximum age

                           Minimum content

                           Maximum content

                           Other provisions

                           End of period of authorisation

                           mg of lecithins/kg of complete feedingstuff with a moisture content of 12 %

                              Category of technological additives. Functional group: emulsifiers

                           1c322

                           —

                           Lecithins

                              Additive composition

                           Preparation of lecithins having a minimum of:

                                       —

                                       phospholipids ≥ 18 %,

                                       —

                                       lysophospholipids ≥ 11 %,

                                 Moisture ≤ 1 %

                              Characterisation of the active substance

                           Lecithins (CAS No 8002-43-5) extracted from soybeans

                              Analytical method
                               (1)

                           For the characterisation of feed additive:
                           Commission Regulation (EU) No 231/2012 (2) and the corresponding tests in the FAO JECFA monograph “Lecithin” (3)
                               (4)

                           All animal species

                           —

                           —

                           —

                           =

                           6 July 2027

                     ’

            (1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

            (2)  Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (OJ L 83, 22.3.2012, p. 1).

            (3)  FAO JECFA Combined Compendium of Food Additive Specifications, “Lecithin”, Monograph No 4 (2007), http://www.fao.org/ag/agn/jecfa-additives/specs/monograph4/additive-250-m4.pdf

            (4)  FAO JECFA Combined Compendium for Food Additive Specifications — Analytical methods, test procedures and laboratory solutions used by and referenced in the food additive specifications, Vol. 4, http://www.fao.org/docrep/009/a0691e/a0691e00.htm


title: Commission Implementing Regulation (EU) 2017/2326 of 14 December 2017 approving imiprothrin as an existing active substance for use in biocidal products of product-type 18 (Text with EEA relevance. )

text:
               15.12.2017

               EN

               Official Journal of the European Union

               L 333/22

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2326
   of 14 December 2017
   approving imiprothrin 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 imiprothrin.

               (2)

               Imiprothrin 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)

               The United Kingdom was designated as evaluating competent authority and submitted the assessment report together with its recommendations on 20 July 2016.

               (4)

               In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinion of the European Chemicals Agency was formulated on 27 June 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

               (5)

               According to that opinion, biocidal products of product-type 18 containing imiprothrin 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 imiprothrin for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.

               (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
   Imiprothrin 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, 14 December 2017.

            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).

      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

                  Imiprothrin

                  IUPAC Name:
                  Reaction mass of: 2,5-dioxo-3-prop-2-ynylimidazolidin-1-ylmethyl (1R)-cis-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate; 2,5-dioxo-3-prop-2-ynylimidazolidin-1-ylmethyl (1R)-trans-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
                  EC No: 428-790-6
                  CAS No: 72963-72-5

                  ≥ 870 g/kg

                  1 July 2019

                  30 June 2029

                  18

                  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 use 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 surface water, sediment and soil for products used indoors as a spray for surface treatment.

                              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.

         (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) 2017/2327 of 14 December 2017 approving 2-methyl-1,2-benzisothiazol-3(2H)-one as an active substance for use in biocidal products of product-type 6 (Text with EEA relevance. )

text:
               15.12.2017

               EN

               Official Journal of the European Union

               L 333/25

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2327
   of 14 December 2017
   approving 2-methyl-1,2-benzisothiazol-3(2H)-one as an active substance for use in biocidal products of product-type 6
   (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 90(2) thereof,
   Whereas:

               (1)

               Poland received on 26 November 2009 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council (2), for the inclusion of the active substance 2-methyl-1,2-benzisothiazol-3(2H)-one in Annex I to that Directive for use in products of product-type 6, in-can preservatives, as described in Annex V to that Directive, which corresponds to product-type 6 as described in Annex V to Regulation (EU) No 528/2012.

               (2)

               Poland submitted the assessment report together with its recommendations on 24 March 2016 in accordance with Article 90(2) of Regulation (EU) No 528/2012.

               (3)

               The opinion of the European Chemicals Agency was formulated on 27 June 2017 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

               (4)

               According to that opinion, biocidal products of product-type 6 containing 2-methyl-1,2-benzisothiazol-3(2H)-one 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 2-methyl-1,2-benzisothiazol-3(2H)-one for use in biocidal products of product-type 6, subject to compliance with certain specifications and conditions.

               (6)

               Since 2-methyl-1,2-benzisothiazol-3(2H)-one meets the criteria for classification as a skin sensitiser sub-category 1A (strong sensitiser) as specified in point 3.4.2.2.1.2 of Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3), treated articles treated with or incorporating 2-methyl-1,2-benzisothiazol-3(2H)-one 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
   2-methyl-1,2-benzisothiazol-3(2H)-one is approved as an active substance for use in biocidal products of product-type 6, 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, 14 December 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 167, 27.6.2012, p. 1.

      (2)  Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).

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

      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

                  2-methyl-1,2-benzisothiazol-3(2H)-one
                  (MBIT)

                  IUPAC Name:
                  2-methyl-1,2-benzisothiazol-3(2H)-one
                  EC No: Not available
                  CAS No: 2527-66-4

                  ≥ 997 g/kg

                  1 July 2018

                  30 June 2028

                  6

                  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 use 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)

                                          surface water and groundwater for the outdoor use of preserved paints and plasters and the use of preserved fluids used in paper, textile or leather production.

                        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 2-methyl-1,2-benzisothiazol-3(2H)-one 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) 2017/2349 of 15 December 2017 amending Implementing Regulation (EU) 2016/2080 as regards the date of entry into storage of the skimmed milk powder sold by a tendering procedure

text:
               16.12.2017

               EN

               Official Journal of the European Union

               L 336/22

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2349
   of 15 December 2017
   amending Implementing Regulation (EU) 2016/2080 as regards the date of entry into storage of the skimmed milk powder sold by a tendering procedure
   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),
   Having regard to Commission Implementing Regulation (EU) 2016/1240 of 18 May 2016 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to public intervention and aid for private storage (2), and in particular Article 28 thereof,
   Whereas:

               (1)

               In order to define the quantities of skimmed milk powder covered by the tendering procedure opened by Commission Implementing Regulation (EU) 2016/2080 (3), Article 1 of that Regulation lays down a time limit before which the skimmed milk powder must have entered into public storage.

               (2)

               Given the current situation on the milk and milk products market in terms of price recovery and the high level of intervention stocks, it is appropriate that an additional volume of skimmed milk powder is made available for sale by changing the date of entry into storage.

               (3)

               Implementing Regulation (EU) 2016/2080 should therefore be amended accordingly.

               (4)

               In order to make the skimmed milk powder available for sale without delay, this Regulation should enter into force on the day after its publication in the Official Journal of the European Union.

               (5)

               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
   In Article 1 of Implementing Regulation (EU) 2016/2080, the date of ‘1 November 2015’ is replaced by ‘1 April 2016’.
   Article 2
   This Regulation shall enter into force on the 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, 15 December 2017.

            For the Commission,

            On behalf of the President,

         Phil HOGAN

            Member of the Commission

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

      (2)  OJ L 206, 30.7.2016, p. 71.

      (3)  Commission Implementing Regulation (EU) 2016/2080 of 25 November 2016 opening the sale of skimmed milk powder by a tendering procedure (OJ L 321, 29.11.2016, p. 45).


title: Commission Implementing Regulation (EU) 2017/2362 of 5 December 2017 entering a name in the register of protected designations of origin and protected geographical indications (‘Lenticchia di Altamura’ (PGI))

text:
               19.12.2017

               EN

               Official Journal of the European Union

               L 337/15

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2362
   of 5 December 2017
   entering a name in the register of protected designations of origin and protected geographical indications (‘Lenticchia di Altamura’ (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, Italy's application to register the name ‘Lenticchia di Altamura’ 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 ‘Lenticchia di Altamura’ should therefore be entered in the register,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The name ‘Lenticchia di Altamura’ (PGI) is hereby entered in the register.
   The name specified in the first paragraph denotes a product in Class 1.6. Fruit, vegetables and cereals, fresh or processed 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, 5 December 2017.

            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 280, 24.8.2017, p. 4.

      (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) 2017/2363 of 6 December 2017 entering a name in the register of protected designations of origin and protected geographical indications (‘Μελεκούνι’ (Melekouni) (PGI))

text:
               19.12.2017

               EN

               Official Journal of the European Union

               L 337/16

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2363
   of 6 December 2017
   entering a name in the register of protected designations of origin and protected geographical indications (‘Μελεκούνι’ (Melekouni) (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, Greece's application to register the name ‘Μελεκούνι’ (Melekouni) 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 ‘Μελεκούνι’ (Melekouni) should therefore be entered in the register,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The name ‘Μελεκούνι’ (Melekouni) (PGI) is hereby entered in the register.
   The name specified in the first paragraph denotes a product in Class 2.3. Bread, pastry, cakes, confectionery, biscuits or other baker's wares 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 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, 6 December 2017.

            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 280, 24.8.2017, p. 7.

      (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) 2017/2369 of 18 December 2017 amending Implementing Regulation (EU) No 743/2013 introducing protective measures on imports of bivalve molluscs from Turkey intended for human consumption, as regards its period of application (Text with EEA relevance. )

text:
               19.12.2017

               EN

               Official Journal of the European Union

               L 337/26

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2369
   of 18 December 2017
   amending Implementing Regulation (EU) No 743/2013 introducing protective measures on imports of bivalve molluscs from Turkey intended for human consumption, as regards its period of application
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the organisation of veterinary checks on products entering the Community from third countries (1), and in particular Article 22(6) thereof,
   Whereas:

               (1)

               Commission Implementing Regulation (EU) No 743/2013 (2) was adopted as audits of the Commission's audit service identified deficiencies in Turkey in the implementation of official controls of the production of bivalve molluscs intended for export to the Union, and as Member States reported non-compliant consignments of bivalve molluscs originating in Turkey which were not fulfilling Union microbiological standards.

               (2)

               The last audit of the Commission's audit service, which took place in September 2015, found significant deficiencies in the control system for bivalve molluscs intended for export to the Union still existed. The Turkish competent authorities presented information regarding the corrective measures initiated to address those deficiencies. However, some of those deficiencies, notably in the performance of laboratories, still exist.

               (3)

               Due to the nature of the products involved, the application of Implementing Regulation (EU) No 743/2013 should therefore be extended until sufficient guarantees have been obtained, tests carried out by Member States demonstrate the compliance of consignments and a follow-up audit confirms that a lifting of the measures is possible.

               (4)

               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
   In the second paragraph of Article 5 of Implementing Regulation (EU) No 743/2013, the date ‘31 December 2017’ is replaced by the date ‘31 December 2021’.
   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, 18 December 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 24, 30.1.1998, p. 9.

      (2)  Commission Implementing Regulation (EU) No 743/2013 of 31 July 2013 on introducing protective measures on imports of bivalve molluscs from Turkey intended for human consumption (OJ L 205, 1.8.2013, p. 1).


title: Commission Implementing Regulation (EU) 2017/2386 of 19 December 2017 establishing the allocation coefficient to be applied to the quantities covered by the applications for import licences lodged from 1 to 7 December 2017 and determining the quantities to be added to the quantity fixed for the subperiod from 1 April to 30 June 2018 under the tariff quotas opened by Regulation (EC) No 1385/2007 in the poultrymeat sector

text:
               20.12.2017

               EN

               Official Journal of the European Union

               L 340/43

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/2386
   of 19 December 2017
   establishing the allocation coefficient to be applied to the quantities covered by the applications for import licences lodged from 1 to 7 December 2017 and determining the quantities to be added to the quantity fixed for the subperiod from 1 April to 30 June 2018 under the tariff quotas opened by Regulation (EC) No 1385/2007 in the poultrymeat sector
   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 188 thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1385/2007 (2) opened annual tariff quotas for imports of poultrymeat products.

               (2)

               For some quotas, the quantities covered by the applications for import licences lodged from 1 to 7 December 2017 for the subperiod from 1 January to 31 March 2018 exceed those available. The extent to which import licences may be issued should therefore be determined by establishing the allocation coefficient to be applied to the quantities requested, calculated in accordance with Article 7(2) of Commission Regulation (EC) No 1301/2006 (3).

               (3)

               The quantities covered by the applications for import licences lodged from 1 to 7 December 2017 for the subperiod from 1 January to 31 March 2018 are, for some quotas, less than those available. The quantities for which applications have not been lodged should therefore be determined and these should be added to the quantity fixed for the following quota subperiod.

               (4)

               In order to ensure the efficient management of the measure, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

         HAS ADOPTED THIS REGULATION:
   Article 1
   1.   The quantities covered by the applications for import licences lodged under Regulation (EC) No 1385/2007 for the subperiod from 1 January to 31 March 2018 shall be multiplied by the allocation coefficient set out in the Annex to this Regulation.
   2.   The quantities for which import licence applications have not been lodged pursuant to Regulation (EC) No 1385/2007, to be added to the subperiod from 1 April to 30 June 2018, are set out in 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, 19 December 2017.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General

            Directorate-General for Agriculture and Rural Development

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

      (2)  Commission Regulation (EC) No 1385/2007 of 26 November 2007 laying down detailed rules for the application of Council Regulation (EC) No 774/94 as regards opening and providing for the administration of certain Community tariff quotas for poultrymeat (OJ L 309, 27.11.2007, p. 47).

      (3)  Commission Regulation (EC) No 1301/2006 of 31 August 2006 laying down common rules for the administration of import tariff quotas for agricultural products managed by a system of import licences (OJ L 238, 1.9.2006, p. 13).

      ANNEX

                  Order No

                  Allocation coefficient — applications lodged for the subperiod from 1 January to 31 March 2018
                  (%)

                  Quantities not applied for, to be added to the quantities available for the subperiod from 1 April to 30 June 2018
                  (kg)

                  09.4410

                  0,121815

                  —

                  09.4411

                  0,124054

                  —

                  09.4412

                  0,124223

                  —

                  09.4420

                  4,646057

                  —

                  09.4421

                  —

                  175 000

                  09.4422

                  0,803288

                  —