title: Commission Implementing Regulation (EU) 2015/114 of 26 January 2015 determining the quantities to be added to the quantity fixed for the subperiod from 1 April to 30 June 2015 under the tariff quota opened by Regulation (EC) No 536/2007 for poultrymeat originating in the United States of America

text:
               27.1.2015

               EN

               Official Journal of the European Union

               L 20/38

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/114
   of 26 January 2015
   determining the quantities to be added to the quantity fixed for the subperiod from 1 April to 30 June 2015 under the tariff quota opened by Regulation (EC) No 536/2007 for poultrymeat originating in the United States of America
   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(2) and (3) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 536/2007 (2) opened an annual tariff quota for imports of poultrymeat products originating in the United States of America.

               (2)

               The quantities covered by the applications for import licences lodged from 1 to 7 December 2014 for the subperiod from 1 January to 31 March 2015 are 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.

               (3)

               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
   The quantities for which import licence applications have not been lodged pursuant to Regulation (EC) No 536/2007, to be added to the subperiod from 1 April to 30 June 2015, 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, 26 January 2015.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General for Agriculture and Rural Development

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

      (2)  Commission Regulation (EC) No 536/2007 of 15 May 2007 opening and providing for the administration of a tariff quota for poultrymeat allocated to the United States of America (OJ L 128, 16.5.2007, p. 6).

      ANNEX

                  Order No

                  Quantities not applied for, to be added to the quantities available for the subperiod from 1 April to 30 June 2015
                  (kg)

                  09.4169

                  16 008 750


title: Council Implementing Regulation (EU) 2017/1090 of 20 June 2017 implementing Article 17(1) of Regulation (EU) No 224/2014 concerning restrictive measures in view of the situation in the Central African Republic

text:
               21.6.2017

               EN

               Official Journal of the European Union

               L 158/1

         COUNCIL IMPLEMENTING REGULATION (EU) 2017/1090
   of 20 June 2017
   implementing Article 17(1) of Regulation (EU) No 224/2014 concerning restrictive measures in view of the situation in the Central African Republic
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EU) No 224/2014 of 10 March 2014 concerning restrictive measures in view of the situation in the Central African Republic (1), and in particular Article 17(1) thereof,
   Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,
   Whereas:

               (1)

               On 10 March 2014, the Council adopted Regulation (EU) No 224/2014.

               (2)

               On 17 May 2017, the United Nations Security Council Committee, established pursuant to United Nations Security Council Resolution 2127 (2013), added one person to the list of persons and entities subject to restrictive measures. On 24 May 2017, the Council adopted Implementing Regulation (EU) 2017/890 (2) adding this person to Annex I to Regulation (EU) No 224/2014.

               (3)

               The information relating to this person should be completed and the Annex I to Regulation (EU) No 224/2014 should therefore be amended accordingly,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex I to Regulation (EU) No 224/2014 is hereby amended as 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 Luxembourg, 20 June 2017.

            For the Council

            The President

         H. DALLI

      (1)  OJ L 70, 11.3.2014, p. 1.

      (2)  Council Implementing Regulation (EU) 2017/890 of 24 May 2017 implementing Article 17(1) of Regulation (EU) No 224/2014 concerning restrictive measures in view of the situation in the Central African Republic (OJ L 138, 25.5.2017, p. 1).

      ANNEX
      The entry in Annex I to Regulation (EU) No 224/2014 concerning the person listed below is replaced by the following entry:

                     ‘12.

                     Abdoulaye HISSENE (alias: a) Abdoulaye Issène; b) Abdoulaye Hissein; c) Hissene Abdoulaye; d) Abdoulaye Issène Ramadane; e) Abdoulaye Issene Ramadan; f) Issene Abdoulaye)

                        Date of birth: 1967

                        Place of birth: Ndele, Bamingui-Bangoran, Central African Republic

                        Nationality: Central African Republic

                        Passport No: CAR diplomatic passport No D00000897, issued on 5 April 2013 (valid until 4 April 2018)

                        Address: a) KM5, Bangui, Central African Republic; b) Nana-Grebizi, Central African Republic

                        Date of UN designation:17 May 2017

                        Other Information: Hissène was formerly the Minister of Youth and Sports as part of the Cabinet for the Central African Republic's former President Michel Djotodia. Prior to that, he was the head of the Convention of Patriots for Justice and Peace, a political party. He also established himself as a leader of armed militias in Bangui, in particular in the ‘PK5’ (3rd district) neighbourhood.

                        Information from the narrative summary of reasons for listing provided by the Sanctions Committee:

                     Abdoulaye Hissène was listed on 17 May 2017 pursuant to paragraphs 16 and 17(g) of resolution 2339(2017) as ‘engaging in or providing support for acts that undermine the peace, stability or security of the CAR, including acts that threaten or impede the political transition process, or the stabilization and reconciliation process or that fuel violence;’ and ‘involved in planning, directing, sponsoring, or conducting attacks against UN missions or international security presences, including MINUSCA, the European Union Missions and French operations which support them.’

                           Additional information:

                     Abdoulaye Hissène and other members of the ex-Séléka collaborated with anti-balaka spoilers allied with former Central African Republic (CAR) President François Bozizé, including Maxime Mokom, to encourage violent protests and clashes in September 2015 as part of a failed coup attempt to bring down the Government while then-Transitional President Catherine Samba-Panza was attending the 2015 UN General Assembly. Mokom, Hissène, and others were indicted by the CAR government for various criminal offenses, including murder, arson, torture, and looting, stemming from the failed coup.
                     Since 2015, Hissène had become one of the main leaders of armed militias located in the ‘PK5’ neighbourhood of Bangui which comprised more than 100 men. As such, he prevented the freedom of movement and the return of state authority in the area, including through illegal taxation of transportation and commercial activities. In the second half of 2015, Hissène acted as the representative of the ex-Séléka ‘Nairobists’ in Bangui operating in a rapprochement with anti-balaka fighters under Mokom. Armed men under the control of Haroun Gaye and Hissène participated in the violent events which took place in Bangui between 26 September and 3 October 2015.
                     Members of Hissène's group are suspected of having been involved in an attack on the 13 December 2015 — the day of the constitutional referendum — on the vehicle of Mohamed Moussa Dhaffane, a leader of the ex-Séléka. Hissène is accused of orchestrating violence in Bangui's KM5 district that killed five, wounded twenty, and prevented residents from voting in the constitutional referendum. Hissène put the elections at risk by creating a cycle of retaliatory attacks between different groups.
                     On 15 March 2016, Hissène was apprehended by the police at Bangui M'poko airport and transferred to the research and investigation section of the national gendarmerie. His militia subsequently released him, using force, and stole one weapon previously handed over by MINUSCA as part of an exemption request approved by the Committee.
                     On 19 June 2016, following the arrest of Muslim traders by internal security forces at ‘PK 12’, militias of Gaye and Hissène kidnapped five national policemen in Bangui. On 20 June, MINUSCA attempted to release the policemen. Armed men under the control of Hissène and Gaye exchanged fire with the peacekeepers attempting to release the hostages. As a result, at least six individuals were killed and one peacekeeper was injured.
                     On 12 August 2016, Hissène took the lead of a 6-vehicles convoy with heavily armed individuals. The convoy, which was fleeing Bangui, was intercepted by MINUSCA south of Sibut. En route to the North, the convoy exchanged fire with internal security forces at several checkpoints. The convoy was eventually stopped by MINUSCA 40 km south of Sibut. After multiple gunfights, MINUSCA captured 11 of the men, but Hissène and several others escaped. Individuals arrested indicated to MINUSCA that Hissène was the leader of the convoy whose objective was to reach Bria and participate in the Assembly of ex-Séléka groups organized by Nourredine Adam.
                     In August and September 2016, the Panel of Experts traveled twice to Sibut in order to inspect the belongings of the convoy of Hissène, Gaye and Hamit Tidjani, seized by MINUSCA on 13 August. The Panel also inspected the ammunition seized in the house of Hissène on 16 August. Lethal and non-lethal military equipment was recovered in the six vehicles and from the apprehended individuals. On 16 August 2016, the Central Gendarmerie raided the home of Hissène in Bangui. More than 700 weapons were found.
                     On 4 September 2016, a group of ex-Séléka elements coming from Kaga-Bandoro on six motor-bikes to pick up Hissène and his affiliates opened fire against MINUSCA next to Dékoa. During this incident, one ex-Séléka fighter was killed, and two peacekeepers and one civilian were wounded.’.


title: Commission Implementing Regulation (EU) 2017/1376 of 25 July 2017 renewing the approval of warfarin as an active substance for use in biocidal products of product-type 14 (Text with EEA relevance. )

text:
               26.7.2017

               EN

               Official Journal of the European Union

               L 194/9

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/1376
   of 25 July 2017
   renewing the approval of warfarin as an active substance for use in biocidal products of product-type 14
   (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 14(4)(a) thereof,
   Whereas:

               (1)

               The active substance warfarin is approved for use in biocidal products of product-type 14 as a rodenticide under Regulation (EU) No 528/2012.

               (2)

               In accordance with Article 13(1) of Regulation (EU) No 528/2012, an application was submitted to the European Chemicals Agency (‘the Agency’) for the renewal of the approval of that active substance. This application was evaluated by the competent authority of Ireland as the evaluating competent authority.

               (3)

               On 25 March 2016, the evaluating competent authority submitted its recommendation on the renewal of the approval of warfarin to the Agency.

               (4)

               On 16 June 2016, the opinion of the Agency was formulated by its Biocidal Products Committee (2), having regard to the conclusions of the evaluating competent authority.

               (5)

               According to that opinion, warfarin meets the criteria in Regulation (EC) No 1272/2008 of the European Parliament and of the Council (3) to be classified as toxic for reproduction category 1A. Warfarin therefore meets the exclusion criterion set in Article 5(1)(c) of Regulation (EU) No 528/2012.

               (6)

               In addition, the use of products containing warfarin raises concerns in relation to instances of primary and secondary poisoning, even where restrictive risk management measures are applied and therefore warfarin also satisfies the criterion to be a candidate for substitution in accordance with Article 10(1)(e) of that Regulation.

               (7)

               Pursuant to Article 12 of Regulation (EU) No 528/2012, the approval of active substances meeting the exclusion criteria may only be renewed when at least one of the conditions for derogation set out in Article 5(2) of that Regulation continues to be satisfied.

               (8)

               In accordance with Article 10(3) of Regulation (EU) No 528/2012, the Agency organised a public consultation in order to collect relevant information on warfarin, including information on available substitutes.

               (9)

               The Commission also carried out a specific public consultation in order to gather information as to whether the conditions for derogation set out in Article 5(2) of Regulation (EU) No 528/2012 were satisfied. The Commission made the contributions to that consultation publicly available.

               (10)

               The contributions to the two above-mentioned public consultations, as well as the information regarding the availability of alternatives to anticoagulant rodenticides included in Annex 1 to the Commission report on risk mitigation measures for anticoagulant rodenticides (4), were discussed with Member States in the Standing Committee on Biocidal Products.

               (11)

               Rodents can carry pathogens that are responsible for many zoonoses, which can pose serious dangers for human or animal health. Non-chemical controls or prevention methods for rodent control, such as mechanical, electrical or glue traps, may not be sufficiently efficient and may raise further questions as to whether they are humane or whether they cause unnecessary suffering to rodents. Alternative active substances approved for use as rodenticides may not be suitable for all user categories or efficient for all rodent species. As effective rodent control cannot rely on those non-chemical controls or prevention methods only, warfarin is considered essential to ensure appropriate rodent control in support of those alternatives. As a consequence the use of warfarin would be to prevent or control a serious danger to human and animal health in which rodents are involved. Therefore, the condition set out in Article 5(2)(b) is satisfied.

               (12)

               Rodent control currently relies largely on the use of anticoagulant rodenticides, the non-approval of which could lead to insufficient rodent control. This may not only cause significant negative impacts on human or animal health or the environment, but also affect the public's perception of its safety with regard to exposure to rodents or the security of a number of economic activities that could be vulnerable to rodents, resulting in economic and social consequences. On the other hand, the risks to human health, animal health or the environment arising from use of products containing warfarin can be mitigated if they are used according to certain specifications and conditions. Therefore, the non-approval of warfarin as an active substance would have a disproportionate negative impact on society in comparison to the risks arising from the use of the substance. The condition set out in Article 5(2)(c) is thus also satisfied.

               (13)

               It is therefore appropriate to renew the approval of warfarin for use in biocidal products of product-type 14, subject to compliance with certain specifications and conditions.

               (14)

               Warfarin is a candidate for substitution in accordance with points (a) and (e) of Article 10(1) of Regulation (EU) No 528/2012 and therefore the period of renewal set out in Article 10(4) of that Regulation should apply.

               (15)

               By Commission Implementing Decision (EU) 2016/135 (5), the initial expiry date of approval of flocoumafen, brodifacoum and warfarin for use in biocidal products of product-type 14 was postponed until 30 June 2018. As the examination of the applications for the renewal of those approvals is now finalised, it is appropriate to repeal Implementing Decision (EU) (EU) 2016/135.

               (16)

               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
   The approval of warfarin as an active substance for use in biocidal products of product-type 14 is renewed, subject to the specifications and conditions set out in the Annex.
   Article 2
   Implementing Decision (EU) 2016/135 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, 25 July 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 167, 27.6.2012, p. 1.

      (2)  https://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances/bpc-opinions-on-active-substance-approval

      (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).

      (4)  Risk mitigation measures for anticoagulant rodenticides — Final Report. European Commission (2014), Brussels, Belgium. 100 pp. ISBN 978-92-79-44992-5.

      (5)  Commission Implementing Decision (EU) 2016/135 of 29 January 2016 postponing the expiry date of approval of flocoumafen, brodifacoum and warfarin for use in biocidal products for product-type 14 (OJ L 25, 2.2.2016, p. 65).

      ANNEX

                  Common Name

                  IUPAC Name
                  Identification Numbers

                  Minimum degree of purity of the active substance (1)

                  Expiry date of approval

                  Product type

                  Specific conditions

                  Warfarin

                  IUPAC Name:
                  (RS)-4-hydroxy-3-(3-oxo-1-phenylbutyl) coumarin
                  EC No: 201-377-6
                  CAS No: 81-81-2

                  990 g/kg

                  30 June 2024

                  14

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

                              (1)

                              The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance. In addition, pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) No 528/2012 can be satisfied.

                              (2)

                              Products shall only be authorised for use in Member States where at least one of the conditions set out in Article 5(2) of Regulation (EU) No 528/2012 is satisfied.

                              (3)

                              The nominal concentration of warfarin in the products shall not exceed 790 mg/kg.

                              (4)

                              Products shall contain an aversive agent and a dye.

                              (5)

                              Products shall not be authorised in the form of tracking powder.

                              (6)

                              Products in the form of contact formulations, other than tracking powder, shall only be authorised for use by trained professionals indoors in places not accessible to children or non-target animals.

                              (7)

                              Products shall not be authorised for use in permanent or pulse baiting treatments.

                              (8)

                              Only ready-to-use products shall be authorised.

                              (9)

                              Primary as well as secondary exposure of humans, non-target animals and the environment are minimised, by considering and applying all appropriate and available risk mitigation measures. These include for example the restriction to professional or trained professional use when possible and setting additional specific conditions per user category.

                              (10)

                              Dead bodies and uneaten bait shall be disposed of in accordance with local requirements. The method of disposal shall be described specifically in the summary of the product characteristics of the national authorisation and be reflected on the product label.

                        In addition to the general conditions, the authorisations of biocidal products to be used by the general public are subject to the following conditions:

                              (1)

                              Products shall only be authorised for use in tamper-resistant bait stations.

                              (2)

                              Products shall only be supplied with a maximum quantity of bait per pack of:

                                          (a)

                                          For products against mice only:

                                                      (i)

                                                      For grain, pellet or paste baits: 250 g.

                                                      (ii)

                                                      For wax block baits: 500 g.

                                          (b)

                                          For products against rats only, or mice and rats:

                                                      (i)

                                                      For grain, pellet or paste baits: 750 g.

                                                      (ii)

                                                      For wax block baits: 1 500  g.

                              (3)

                              Products against Rattus norvegicus and Rattus rattus shall only be authorised for use indoors or in and around buildings.

                              (4)

                              Products against Mus musculus shall only be authorised for use indoors.

                              (5)

                              Persons making products available on the market shall ensure that the products are accompanied by information on the risks associated with anticoagulant rodenticides in general, measures to limit their use to the minimum necessary and appropriate precautionary steps to be taken.

                              (6)

                              Products in the form of loose bait formulations, such as grain or pellets, shall only be authorised in formulations that are supplied in sachets or other packaging to reduce exposure to humans and the environment.

                        In addition to the general conditions, the authorisations of biocidal products to be used by professionals are subject to the following conditions:

                              (1)

                              Products shall not be authorised for use in sewers, open area or waste dumps.

                              (2)

                              Products shall only be authorised for use in tamper-resistant bait stations.

                              (3)

                              Persons making products for professional users available on the market shall make sure that these products are not supplied to the general public.

                        In addition to the general conditions, the authorisations of biocidal products to be used by trained professionals are subject to the following conditions:

                              (1)

                              Products may be authorised for use in sewers, open area or waste dumps.

                              (2)

                              Products may be authorised for use in covered and protected bait points as long as they provide the same level of protection for non-target species and humans as tamper-resistant bait stations.

                              (3)

                              Persons making products for trained professional users available on the market shall make sure that the products are not supplied to other persons than trained professionals.

         (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) 2017/1222 of 26 June 2017 entering a name in the register of protected designations of origin and protected geographical indications [Kiełbasa biała parzona wielkopolska (PGI)]

text:
               7.7.2017

               EN

               Official Journal of the European Union

               L 174/13

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/1222
   of 26 June 2017
   entering a name in the register of protected designations of origin and protected geographical indications [Kiełbasa biała parzona wielkopolska (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, Poland's application to register the name ‘Kiełbasa biała parzona wielkopolska’ was published in the Official Journal of the European Union
                   (2).

               (2)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The name ‘Kiełbasa biała parzona wielkopolska’ (PGI) is hereby entered in the register.
   The name specified in the first paragraph denotes a product in Class 1.2. — Meat products (cooked, salted, smoked, etc.), as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 26 June 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 73, 9.3.2017, p. 25.

      (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) No 237/2012 of 19 March 2012 concerning the authorisation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) as a feed additive for chickens for fattening (holder of authorisation Kerry Ingredients and Flavours)  Text with EEA relevance

text:
               20.3.2012

               EN

               Official Journal of the European Union

               L 80/1

         COMMISSION IMPLEMENTING REGULATION (EU) No 237/2012
   of 19 March 2012
   concerning the authorisation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) as a feed additive for chickens for fattening (holder of authorisation Kerry Ingredients and Flavours)
   (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.

               (2)

               In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

               (3)

               The application concerns the authorisation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) as a feed additive for chickens for fattening, to be classified in the additive category ‘zootechnical additives’.

               (4)

               The European Food Safety Authority (‘the Authority’) concluded in its opinion of 17 November 2011 (2) that, under the proposed conditions of use, the preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) does not have an adverse effect on animal health, human health or the environment, and that its use can improve the final body weight in chickens for fattening. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

               (5)

               The assessment of the preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this preparation should be authorised as specified in the Annex to this Regulation.

               (6)

               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
   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, 19 March 2012.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  EFSA Journal 2011; 9(12):2451.

      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

                  Units of activity/kg of complete feedingstuff with a moisture content of 12 %

                     Category of zootechnical additives. Functional group: digestibility enhancers

                  4a17

                  Kerry Ingredients and Flavours

                  Alpha-galactosidase
                  (EC 3.2.1.22)
                  Endo-1,4-beta-glucanase
                  (EC 3.2.1.4)

                                 Additive composition

                              Preparation of alpha-galactosidase (EC 3.2.1.22) produced by Saccharomyces cerevisiae (CBS 615.94) and endo-1,4-beta-glucanase (EC 3.2.1.4) produced by Aspergillus niger (CBS 120604), solid form, with a minimum activity of:

                                          —

                                          1 000 U (1) alpha-galactosidase/g

                                          —

                                          5 700 U (2) endo-1,4-beta-glucanase/g

                                 Characterisation of the active substance

                              Alpha-galactosidase produced by Saccharomyces cerevisiae (CBS 615.94) Endo-1,4-beta-glucanase produced by Aspergillus niger (CBS 120604)

                                 Method of Analysis
                                  (3)

                              Determination:

                                          —

                                          colorimetric method measuring p-nitrophenol released by action of alpha-galactosidase from p-nitrophenyl-alpha-galactopyranoside substrate,

                                          —

                                          colorimetric method measuring water soluble dye released by action of endo-1,4-beta-glucanase from azurine-crosslinked barley glucan substrate.

                  Chickens for fattening

                  —

                  50 U alpha-galactosidase
                  285 U endo-1,4-beta-glucanase

                  —

                              1.

                              In the directions for use of the additive and premixture, indicate the storage temperature, storage life, and stability to pelleting.

                              2.

                              Maximum recommended dose:

                                          —

                                          100 U alpha-galactosidase/kg

                                          —

                                          570 U endo-1,4-beta-glucanase/kg.

                              3.

                              For safety: breathing protection, glasses and gloves shall be used during handling.

                  9 April 2022

         (1)  1 U is the amount of the enzyme which liberates 1 μmol of p-nitrolphenol per minute from p-nitrophenyl-alpha-galactopyranoside (pNPG) at pH 5,0 and 37 °C.

         (2)  1 U is the amount of the enzyme which liberates 1 mg of reducing sugar (glucose equivalent) per minute from beta-glucan at pH 5,0 and 50 °C.

         (3)  Details of the analytical methods are available at the following address of the Reference Laboratory: http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/Pages/index.aspx


title: Commission Implementing Regulation (EU) 2017/1914 of 19 October 2017 concerning the authorisation of salinomycin sodium (Sacox 120 microGranulate and Sacox 200 microGranulate) as a feed additive for chickens for fattening and chickens reared for laying and repealing Regulations (EC) No 1852/2003 and (EC) No 1463/2004 (holder of authorisation Huvepharma NV) (Text with EEA relevance. )

text:
                  20.10.2017

                  EN

                  Official Journal of the European Union

                  L 271/1

            COMMISSION IMPLEMENTING REGULATION (EU) 2017/1914
      of 19 October 2017
      concerning the authorisation of salinomycin sodium (Sacox 120 microGranulate and Sacox 200 microGranulate) as a feed additive for chickens for fattening and chickens reared for laying and repealing Regulations (EC) No 1852/2003 and (EC) No 1463/2004 (holder of authorisation Huvepharma NV)
      (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) and 13(3) 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)

                  Salinomycin sodium 120 g/kg (Sacox 120 microGranulate) was authorised for 10 years in accordance with Directive 70/524/EEC as feed additive for chickens reared for laying by Commission Regulation (EC) No 1852/2003 (3) and for chickens for fattening by Commission Regulation (EC) No 1463/2004 (4). That additive was subsequently entered in the Register of feed additives as an existing product, 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, an application was submitted for the re-evaluation of salinomycin sodium 120 g/kg (Sacox 120 microGranulate) as a feed additive for chickens for fattening and chickens reared for laying. In accordance with Article 7 of that Regulation, an application was submitted for the authorisation of the new formulation of salinomycin sodium 200 g/kg (Sacox 200 microGranulate) requesting that additive to be classified in the additive category ‘coccidiostats and histomonostas’. In accordance with Article 13(3) of that Regulation, an application was submitted requesting the reduction of the withdrawal time before slaughter from one to zero days and requesting a modification of the Maximum Residue Levels (‘MRLs’) for that additive from 5 μg/kg of all wet tissues to 0,150 mg/kg of liver, 0,040 mg/kg of kidney, 0,015 mg/kg of muscle and 0,150 mg/kg of skin/fat. Those applications were 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 6 December 2016 (5) that, under the proposed conditions of use, the salinomycin sodium 120 g/kg (Sacox 120 microGranulate) and salinomycin sodium 200 g/kg (Sacox 200 microGranulate) do not have an adverse effect on animal health, human health or the environment. The Authority further concluded that the use of the salinomycin sodium 120 g/kg (Sacox 120 microGranulate) and of salinomycin sodium 200 g/kg (Sacox 200 microGranulate) is effective in the control of coccidiosis in chickens for fattening and that, by the provided studies, the conclusion is extended to chickens reared for laying. The Authority also concluded that the exposure estimates at the highest use level indicated an acceptable withdrawal time of zero days. The Authority also concluded that it is not necessary to set MRLs. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                  (5)

                  However for control reasons, MRLs, as applied for, should be set for liver, kidney, muscle and skin/fat. It was also considered that field monitoring of Eimeria spp. resistance to salinomycin sodium shall be undertaken, preferably during the latter part of the period of authorisation.

                  (6)

                  The assessment of the salinomycin sodium (Sacox 120 microGranulate and Sacox 200 microGranulate) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

                  (7)

                  Regulations (EC) No 1852/2003 and (EC) No 1463/2004 should be repealed.

                  (8)

                  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.

                  (9)

                  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 preparations specified in the Annex, belonging to the additive category ‘coccidiostats and histomonostas’ are authorised as a coccidiostat in animal nutrition, subject to the conditions laid down in the Annex.
      Article 2
      Repeal of Regulation (EC) No 1852/2003
      Regulation (EC) No 1852/2003 is repealed.
      Article 3
      Repeal of Regulation (EC) No 1463/2004
      Regulation (EC) No 1463/2004 is repealed.
      Article 4
      Transitional measures
      The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 9 May 2018 in accordance with the rules applicable before 9 November 2017 may continue to be placed on the market and used until the existing stocks are exhausted.
      Article 5
      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, 19 October 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)  Commission Regulation (EC) No 1852/2003 of 21 October 2003 authorising the use for 10 years of a coccidiostat in feedingstuffs (OJ L 271, 22.10.2003, p. 13).

         (4)  Commission Regulation (EC) No 1463/2004 of 17 August 2004 concerning the authorisation for 10 years of the additive ‘Sacox 120 microGranulate’ in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances (OJ L 270, 18.8.2004, p. 5).

         (5)  EFSA Journal 2017; 15(1):4670.

         ANNEX

                     Identification number of the additive

                     Name of the holder of authorisation

                     Additive
                     (trade name)

                     Composition, chemical formula, description, analytical method

                     Species or category of animal

                     Maximum age

                     Minimum content

                     Maximum content

                     Other provisions

                     End of period of authorisation

                     Maximum Residue Limits (MRLs) in the relevant foodstuffs of animal origin

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

                        Coccidiostats and histomonostats

                     51766

                     Huvepharma NV.

                     Salinomycin sodium 120 g/kg
                     (Sacox 120 microGranulate)
                     Salinomycin sodium 200 g/kg
                     (Sacox 200 microGranulate)

                        Additive composition

                     (Sacox120 microGranulate):

                                 Salinomycin sodium: 114-132 g/kg

                                 Silicon dioxide: 10-100 g/kg

                                 Calcium carbonate: 500-700 g/kg

                           Solid form
                     (Sacox 200 microGranulate):

                                 Salinomycin sodium: 190-220 g/kg

                                 Silicon dioxide: 50-150 g/kg

                                 Calcium carbonate: 50-150 g/kg

                           Solid form

                        Characterisation of the active substance

                     Salinomycin sodium,
                     C42H69Na O11,
                     CAS number: 55721-31-8,
                     sodium salt of a polyether monocarboxylic acid produced by fermentation of Streptomyces azureus (DSM 32267)
                     Related impurities:

                                 —

                                 ≤ 10 mg elaiophylin/kg salinomycin sodium.

                                 —

                                 ≤ 2 g 17-epi-20-desoxy-salinomycin/kg salinomycin sodium.

                                 —

                                 ≤ 10 g 20-desoxysalinomycin/kg salinomycin sodium.

                                 —

                                 ≤ 10 g 18,19-dihydrosalinomycin/kg salinomycin sodium.

                                 —

                                 ≤ 10 g methylated salinomycin/kg salinomycin sodium.

                        Analytical method
                         (1)

                     For the quantification of salinomycin in the feed additive:
                     High Performance Liquid Chromatography using post-column derivatisation coupled to spectrophotometric detection (HPLC-PCD-UV-Vis).
                     For the quantification of salinomycin in premixtures and feedingstuffs:
                     High Performance Liquid Chromatography using post-column derivatisation coupled to spectrophotometric detection (HPLC-PCD-UV-Vis) — EN ISO 14183.

                     Chickens for fattening

                     —

                     50

                     70

                                 1.

                                 The additives shall be incorporated in compound feed in the form of a premixture.

                                 2.

                                 The following shall be indicated in the instructions for use:
                                 ‘Dangerous for equines and turkeys.
                                 This feedingstuff contains an ionophore:
                                 simultaneous use with certain medicinal substances (e.g. tiamulin) can be contra-indicated’.

                                 3.

                                 Salinomycin sodium shall not be mixed with other coccidiostats.

                                 4.

                                 A post-market monitoring program on the resistance to bacteria and Eimeria spp. shall be planned and executed by the holder of authorisation.

                                 5.

                                 Zero days of withdrawal time.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing, eyes and skin protections.

                     9 November 2027

                     150 μg salinomycin sodium/kg of liver;
                     40 μg salinomycin sodium/kg of kidney;
                     15 μg salinomycin sodium/kg of muscle, and 150 μg salinomycin sodium/kg. skin/fat.

                     Chickens reared for laying

                     12 weeks

                     50

                     50

            (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


title: Commission Implementing Regulation (EU) 2017/822 of 15 May 2017 amending Implementing Regulation (EU) No 343/2011 opening and providing for the administration of Union tariff quotas for wines originating in Bosnia and Herzegovina

text:
               16.5.2017

               EN

               Official Journal of the European Union

               L 123/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/822
   of 15 May 2017
   amending Implementing Regulation (EU) No 343/2011 opening and providing for the administration of Union tariff quotas for wines originating in Bosnia and Herzegovina
   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 187 thereof,
   Whereas:

               (1)

               The Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and Bosnia and Herzegovina, of the other part (2) (‘the SAA’) was signed on 16 June 2008 and entered into force on 1 June 2015.

               (2)

               The Protocol to the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and Bosnia and Herzegovina, of the other part, to take account of the accession of the Republic of Croatia to the European Union (3) (‘the Protocol’) was signed on 15 December 2016. Its signature on behalf of the Union and its Member States and its provisional application has been authorised by Council Decision (EU) 2017/75 (4). The Protocol applies provisionally with effect from 1 February 2017.

               (3)

               Article 5 of the Protocol and Annex IV thereto provide for changes to the existing tariff quotas for wines originating in Bosnia and Herzegovina with effect from 1 February 2017. The relevant quotas for wines have been increased from 12 800 hl to 25 500 hl, applying to positions ex 2204 10 and ex 2204 21, and from 3 200 hl to 15 100 hl, applying to positions ex 2204 22 and ex 2204 29.

               (4)

               The SAA specifies that the preferential zero-duty within the tariff quotas is granted subject to the condition that no export subsidies are paid for exports of these quantities by Bosnia and Herzegovina. In addition, the Protocol specifies that for the year 2017 the full amount of the quotas applies irrespective of the date of entry into force or provisional application of the Protocol.

               (5)

               To implement the Union tariff quotas for wine laid down in the Protocol, Commission Implementing Regulation (EU) No 343/2011 (5) should therefore be amended accordingly.

               (6)

               Since the Protocol applies from 1 February 2017, the proposed amendments should apply from the same date.

               (7)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The Annex to Implementing Regulation (EU) No 343/2011 is replaced by the text set out in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 February 2017.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 15 May 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  OJ L 164, 30.6.2015, p. 2.

      (3)  OJ L 12, 17.1.2017, p. 3.

      (4)  Council Decision (EU) 2017/75 of 21 November 2016 on the signing, on behalf of the Union and its Member States, and provisional application of the Protocol to the Stabilisation and Association Agreement between the European Communities and their Member States, of the one part, and Bosnia and Herzegovina, of the other part, to take account of the accession of the Republic of Croatia to the European Union (OJ L 12, 17.1.2017, p. 1).

      (5)  Commission Implementing Regulation (EU) No 343/2011 of 8 April 2011 opening and providing for the administration of Union tariff quotas for wines originating in Bosnia and Herzegovina (OJ L 96, 9.4.2011, p. 12).

      ANNEX
      ‘
            ANNEX

               Tariff quotas for wines originating in Bosnia and Herzegovina imported into the Union

                        Order No

                        CN code (1)

                        TARIC Extension

                        Description

                        Annual quota volume (in hl) (2)

                        Tariff quota duty (3)

                        09.1528

                        2204 10 93

                        “Quality sparkling wine; other wine of fresh grapes, in containers holding 2 litres or less”.

                        25 500

                        Exemption

                        2204 10 94

                        2204 10 96

                        2204 10 98

                        2204 21 06

                        2204 21 07

                        2204 21 08

                        2204 21 09

                        ex 2204 21 93

                        19, 29, 31, 41 and 51

                        ex 2204 21 94

                        19, 29, 31, 41 and 51

                        2204 21 95

                        ex 2204 21 96

                        11, 21, 31, 41 and 51

                        2204 21 97

                        ex 2204 21 98

                        11, 21, 31, 41 and 51

                        09.1529

                        2204 22 10

                        Other wine of fresh grapes, in containers holding more than 2 litres but not more than 10 litres

                        15 100

                        Exemption

                        2204 22 93

                        11, 21, 31, 41 and 51

                        ex 2204 22 94

                        2204 22 95

                        11, 21, 31, 41 and 51

                        ex 2204 22 96

                        2204 22 97

                        11, 21, 31, 41 and 51

                        2204 22 98

                        2204 29 10

                        2204 29 93

                        ex 2204 29 94

                        11, 21, 31, 41 and 51

                        2204 29 95

                        ex 2204 29 96

                        11, 21, 31, 41 and 51

                        2204 29 97

                        ex 2204 29 98

                        11, 21, 31, 41 and 51

                  ’

         (1)  Notwithstanding the rules for the interpretation of the Combined Nomenclature, the wording for the description of the products is to be considered as having no more than an indicative value, the preferential scheme being determined, within the context of this Annex, by the coverage of CN codes. Where ex CN codes are indicated, the preferential scheme is to be determined by application of the CN code and corresponding description taken together.

         (2)  Consultations at the request of one of the Parties may be held to adapt the quotas by transferring quantities from the quota applying to positions ex 2204 22 and ex 2204 29 (order number 09.1529) to the quota applying to positions ex 2204 10 and ex 2204 21 (order number 09.1528). For the year 2017 the full amount of the quotas shall apply, irrespective of the date of entry into force or provisional application of the Protocol.

         (3)  The VI1 certificate established according to Article 43 of Commission Regulation (EC) No 555/2008 of 27 June 2008 laying down detailed rules for implementing Council Regulation (EC) No 479/2008 on the common organisation of the market in wine as regards support programmes, trade with third countries, production potential and on controls in the wine sector (OJ L 170, 30.6.2008, p. 1), shall mention compliance with this requirement as follows: “The products listed on this certificate do not benefit from export subsidies”.


title: Commission Implementing Regulation (EU) No 1271/2012 of 21 December 2012 derogating from certain provisions of Regulation (EC) No 1122/2009 as regards the possibilities for lodging applications for aid under the single payment scheme for 2012 and for allocation of payment entitlements, or increase of their unit value, from the national reserve in 2012, and as regards contents of the single application, of Regulation (EC) No 1120/2009 as regards the declaration of payment entitlements in 2012 and of Council Regulation (EC) No 73/2009 as regards the verification of eligibility conditions before payments and the date at which parcels need to be at the disposal of farmers

text:
               28.12.2012

               EN

               Official Journal of the European Union

               L 357/10

         COMMISSION IMPLEMENTING REGULATION (EU) No 1271/2012
   of 21 December 2012
   derogating from certain provisions of Regulation (EC) No 1122/2009 as regards the possibilities for lodging applications for aid under the single payment scheme for 2012 and for allocation of payment entitlements, or increase of their unit value, from the national reserve in 2012, and as regards contents of the single application, of Regulation (EC) No 1120/2009 as regards the declaration of payment entitlements in 2012 and of Council Regulation (EC) No 73/2009 as regards the verification of eligibility conditions before payments and the date at which parcels need to be at the disposal of farmers
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 73/2009 of 19 January 2009 establishing common rules for direct support schemes for farmers under the common agricultural policy and establishing certain support schemes for farmers, amending Regulations (EC) No 1290/2005, (EC) No 247/2006, (EC) No 378/2007 and repealing Regulation (EC) No 1782/2003 (1), and in particular Article 142 (c) and (r) thereof,
   Whereas:

               (1)

               Article 41(3) of Regulation (EC) No 73/2009 provides for the possibility of Member States not applying Article 68(1)(c) of that Regulation to use the national reserve under certain conditions. When applying that Article, Member States may increase the unit value and/or the number of payment entitlements allocated to farmers. According to Article 15(1) of Commission Regulation (EC) No 1122/2009 (2) applications for allocation or increase of payment entitlements under the single payment scheme for the purpose of Article 41 of Regulation (EC) No 73/2009 have to be submitted by a date to be fixed by the Member States. This date has not to be later than 15 May or, in the case of Estonia, Latvia, Lithuania, Finland and Sweden, not later than 15 June.

               (2)

               According to Article 11(1) of Regulation (EC) No 1122/2009 the farmer applying for aid under any of the area-related aid schemes may only submit one single application per year.

               (3)

               According to Article 11(2) of Regulation (EC) No 1122/2009 the single application has to be submitted by a date to be fixed by the Member States which has not to be later than 15 May or, in the case of Estonia, Latvia, Lithuania, Finland and Sweden, not later than 15 June.

               (4)

               As a result of a continuous increase of feed prices due to adverse climatic conditions affecting some of the most important suppliers of grains, several Member States are facing an aggravation of the economic situation of agricultural holdings which, at the end of the year 2012, are encountering severe financial difficulties. Considering that the aggravation of the economic situation of the agricultural holdings could also have long-term and broader consequences, it should be allowed for the Member States to apply, for the year 2012, Article 41(3) of Regulation (EC) No 73/2009.

               (5)

               Since the deadline for allocation, or increase of the unit value, of payment entitlements from the national reserve under Article 15(1) of Regulation (EC) No 1122/2009 for the year 2012 has already expired, it is appropriate to allow those Member States who wish to apply Article 41(3) of Regulation (EC) No 73/2009 for the year 2012 to set a new deadline for lodging an application for the allocation, or increase of the unit value, of payment entitlements from the national reserve.

               (6)

               Furthermore, it is appropriate to derogate for farmers in these Member States from the requirement under Article 11(1) of Regulation (EC) No 1122/2009 to submit one single application per year.

               (7)

               In addition, a derogation from the deadline under Article 11(2) of Regulation (EC) No 1122/2009 is necessary in respect of those farmers who wish to benefit from Article 41(3) of Regulation (EC) No 73/2009.

               (8)

               According to Article 12(5) of Regulation (EC) No 1122/2009, in the first year of the single payment scheme or of the year of integration of new sectors into the single payment scheme, Member States may derogate from Article 12 of Regulation (EC) No 1122/2009 concerning payment entitlements if those are not yet definitively established at the latest date fixed for the submission of the single application. It is necessary to provide for a similar derogation concerning payment entitlements which will be allocated, or increased in their unit value, on the basis of Article 41(3) of Regulation (EC) No 73/2009 where such allocation or increase are not yet definitively established.

               (9)

               According to Article 8(1) of Commission Regulation (EC) No 1120/2009 (3) payment entitlements may only be declared for payment once per year by the farmer who holds them at the latest date for lodging the single application. It is appropriate to derogate from this requirement.

               (10)

               According to Article 35(1) of Regulation (EC) No 73/2009, parcels corresponding to the eligible hectares, which are declared for accompanying any payment entitlement, have to be at the farmer’s disposal on a date fixed by the Member State. This date has not to be later than the date fixed in that Member State for amending the aid application.

               (11)

               As regards the payment entitlements that will be allocated, or the unit value of which will be increased, following the application of Article 41(3) of Regulation (EC) No 73/2009, it is necessary to derogate from the farmers’ obligation in respect of the date laid down in Article 35(1) of that Regulation.

               (12)

               Pursuant to Article 29(3) of Regulation (EC) No 73/2009, payments under support schemes listed in Annex I to that Regulation have not to be made before the verification of eligibility conditions, to be carried out by the Member State according to Article 20 of that Regulation, has been finalised.

               (13)

               The eligibility conditions to be verified by the Member States, which are related to the allocation, or increase of the unit value of payment entitlements under Article 41(3) of Regulation (EC) No 73/2009 on the basis of one or several of the derogations set out in this Regulation, may differ from the eligibility conditions for the support currently implemented under the Single Payment Scheme. In that case, the verification of the new eligibility conditions would, pursuant to Article 29(3) of Regulation (EC) No 73/2009, hinder payments for support schemes not related to the application of Article 41(3) of that Regulation to be made before these new eligibility conditions have been verified. In order to avoid such a situation, a derogation from Article 29(3) of Regulation (EC) No 73/2009 related to the allocation, or increase of the unit value, of payment entitlements under Article 41(3) of that Regulation is necessary.

               (14)

               Furthermore, according to Article 29(2) of Regulation (EC) No 73/2009 payments have to be made within the period from 1 December to 30 June of the following calendar year. By derogation from this provision, the Commission may provide for advances before 1 December. Such a derogation is granted in Commission Implementing Regulation (EU) No 776/2012 (4), according to which Member States may pay, from 16 October 2012, advances up to a certain limit of direct payments in respect of applications made in 2012. The derogation from Article 29(3) of Regulation (EC) No 73/2009 should therefore be granted retroactively, from 16 October 2012 in order to allow payment, subject to finalisation of the verification of the eligibility conditions, for those support schemes which are not related to the application of Article 41(3) of that Regulation.

               (15)

               The derogations provided for in this Regulation relate to the calendar year 2012. Therefore, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union.

               (16)

               The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Direct Payments,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Derogations from Regulation (EC) No 1122/2009
   1.   By way of derogation from Article 15(1) of Regulation (EC) No 1122/2009, for the year 2012, Member States may authorise farmers to submit an application for the allocation, or increase of the unit value, of payment entitlements in accordance with Article 41(3) of Regulation (EC) No 73/2009 before 31 January 2013 at the latest.
   2.   By way of derogation from the first subparagraph of Article 11(1) of Regulation (EC) No 1122/2009, for the year 2012, farmers who submitted the single application for aid under any of the area-related aid schemes by a date fixed by the Member States in accordance with Article 11(2) of that Regulation and who, pursuant to paragraph 1 of this Article, submitted an application for allocation, or increase of the unit value, of payment entitlements, may submit a separate application for aid for the purpose of Article 41(3) of Regulation (EC) No 73/2009, before 31 January 2013 at the latest.
   3.   By way of derogation from the first subparagraph of Article 11(2) of Regulation (EC) No 1122/2009, for the year 2012, Member States may authorise farmers, who pursuant to paragraph 1 of this Article submitted an application for allocation, or increase of the unit value, of payment entitlements and who have not submitted the single application referred to in the second paragraph of this Article, to submit a single application for aid under Article 41(3) of Regulation (EC) No 73/2009 before 31 January 2013 at the latest.
   4.   The application for allocation, or increase of the unit value, of payment entitlements submitted pursuant to paragraph 1 shall be considered as a separate application for aid or a single application for aid pursuant to paragraphs 2 and 3.
   5.   Where paragraph 1 of this Article is applied, Member States may derogate from the provisions of Article 12 of Regulation (EC) No 1122/2009 concerning payment entitlements if their allocation, or the increases of their unit values, are not yet definitively established at the latest date fixed in paragraph 2 and 3 of this Article.
   Article 2
   Derogation from Regulation (EC) No 1120/2009
   By way of derogation from the first subparagraph of Article 8(1) of Regulation (EC) No 1120/2009, for the year 2012, payment entitlements, whose unit value is subject to an increase pursuant to Article 1 of this Regulation, may be declared for payment of the respective increase of their unit value by the farmer who holds them at 31 January 2013.
   Payment entitlements newly allocated to farmers and increases of payment entitlements whose unit value is subject to an increase, pursuant to Article 1 of this Regulation, shall be considered declared for the calendar year 2012.
   Article 3
   Derogation from Regulation (EC) No 73/2009
   1.   No payment related to the allocation, or increase of the unit value, of payment entitlements under Article 41(3) of Regulation (EC) No 73/2009 may be made for the calendar year 2012 before finalising the verification of the eligibility conditions applicable to that support carried out by the Member State concerned, where recourse has been had to one or several of the derogations set out in Articles 1 and 2 of this Regulation.
   2.   By way of derogation from Article 29(3) of Regulation (EC) No 73/2009, payments under support schemes listed in Annex I thereto, other than the support referred to in paragraph 1 of this Article, may be made for the calendar year 2012 irrespective of finalising the verification of the eligibility conditions applicable to the support referred to in paragraph 1 of this Article.
   3.   By way of derogation from Article 35(1) of Regulation (EC) No 73/2009, the parcels corresponding to the eligible hectares accompanying any payment entitlements newly allocated, or whose unit value has been increased, in accordance with Article 41(3) of that Regulation on the basis of one or several of the derogations set out in Articles 1 and 2 of this Regulation, shall be at the relevant farmers’ disposal on 31 January 2013.
   Article 4
   Entry into force and application
   This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

   Article 3(1) and (2) shall apply from 16 October 2012.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 21 December 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 30, 31.1.2009, p. 16.

      (2)  OJ L 316, 2.12.2009, p. 65.

      (3)  OJ L 316, 2.12.2009, p. 1.

      (4)  OJ L 231, 28.8.2012, p. 8.


title: Council Implementing Regulation (EU) No 580/2010 of 29 June 2010 amending Regulation (EC) No 452/2007 imposing a definitive anti-dumping duty on imports of ironing boards originating, inter alia, in Ukraine

text:
               2.7.2010

               EN

               Official Journal of the European Union

               L 168/12

         COUNCIL IMPLEMENTING REGULATION (EU) No 580/2010
   of 29 June 2010
   amending Regulation (EC) No 452/2007 imposing a definitive anti-dumping duty on imports of ironing boards originating, inter alia, in Ukraine
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1225/2009 of 30 November 2009 on protection against dumped imports from countries not members of the European Community (1) (the basic Regulation), and in particular Article 11(3) thereof,
   Having regard to the proposal submitted by the European Commission after consulting the Advisory Committee,
   Whereas:
   1.   PROCEDURE

   1.1.   Measures in force

               (1)

               The Council, by Regulation (EC) No 452/2007 (2) (the original Regulation), imposed a definitive anti-dumping duty on imports of ironing boards originating, inter alia, in Ukraine. The measures consist of an ad valorem duty at a rate of 9,9 %.

         1.2.   Request for a review

               (2)

               In August 2008, the Commission received a request for a partial interim review pursuant to Article 11(3) of the basic Regulation (the interim review). The request was completed in December 2008. The request, limited in scope to the examination of dumping, was lodged by an exporting producer from Ukraine, Eurogold Industries Ltd (‘the applicant’ or ‘EGI’). The applicant had cooperated in the investigation which led to the findings and conclusions laid down in the original Regulation (the original investigation). The anti-dumping duty applicable to the applicant, which is the only known exporting producer of the product concerned in Ukraine, is 9,9 %.

               (3)

               In its request, the applicant claimed that the circumstances on the basis of which measures were imposed have changed and that these changes are of a lasting nature. The applicant provided prima facie evidence that the continued imposition of the measure at its current level is no longer necessary to offset dumping.

         1.3.   Initiation of a review

               (4)

               Having determined, after consulting the Advisory Committee, that sufficient evidence existed for the initiation of an interim review, the Commission decided to initiate a partial interim review in accordance with Article 11(3) of the basic Regulation, limited in scope to the examination of dumping as far as EGI is concerned. The Commission published a notice of initiation on 9 April 2009 in the Official Journal of the European Union
                   (3) (Notice of initiation) and commenced an investigation.

         1.4.   Product concerned and like product

               (5)

               The product concerned by the interim review is the same as that in the original investigation, i.e. ironing boards, whether or not free-standing, with or without a steam soaking and/or heating top and/or blowing top, including sleeve boards, and essential parts thereof, i.e. the legs, the top and the iron rest, originating in Ukraine, currently falling within CN codes ex 3924 90 00, ex 4421 90 98, ex 7323 93 90, ex 7323 99 91, ex 7323 99 99, ex 8516 79 70 and ex 8516 90 00.

               (6)

               The product produced and sold in Ukraine and that exported to the Union have the same basic physical and technical characteristics and uses and are therefore considered to be alike within the meaning of Article 1(4) of the basic Regulation.

         1.5.   Parties concerned

               (7)

               The Commission officially advised the Union industry, the applicant and the authorities of the exporting country of the initiation of the interim review. Interested parties were given the opportunity to make their views known in writing and to be heard.

               (8)

               The Commission sent a questionnaire to the applicant and received a reply within the deadline set for that purpose. The Commission sought and verified all the information it deemed necessary for the determination of dumping, and a verification visit was carried out at the premises of the applicant:

                           —

                           Eurogold Industries Ltd, Zhitomir, Ukraine,

                           —

                           and its related company Eurogold Service Zumbühl & Co., Zug in Switzerland (EGS).

         1.6.   Investigation period

               (9)

               The investigation covered the period from 1 January 2008 to 31 December 2008 (‘the investigation period’ or ‘IP’).

         2.   RESULTS OF THE INVESTIGATION

   2.1.   Normal value

               (10)

               For the determination of normal value, it was first established whether EGI’s total volume of domestic sales of the like product to independent customers was representative in comparison with its total volume of export sales to the Union. In accordance with Article 2(2) of the basic Regulation domestic sales are considered to be representative when the total domestic sales volume is at least 5 % of the total volume of sales of the product concerned to the Union. It was found that the overall sales by EGI of the like product on the domestic market were representative.

               (11)

               For each product type sold by EGI on its domestic market and found to be directly comparable with the product type sold for export to the Union, it was established whether domestic sales were sufficiently representative for the purposes of Article 2(2) of the basic Regulation. Domestic sales of a particular product type were considered sufficiently representative when the total volume of that product type sold on the domestic market to independent customers during the IP represented at least 5 % of the total sales volume of the comparable product type exported to the Union.

               (12)

               It was also examined whether the domestic sales of each product type could be regarded as being made in the ordinary course of trade pursuant to Article 2(4) of the basic Regulation. This was done by establishing the proportion of domestic sales to independent customers on the domestic market which were profitable for each exported type of the product concerned during the IP.

               (13)

               For those product types where more than 80 % by volume of sales on the domestic market of the product type were above cost and the weighted average sales price of that type was equal to or above the unit cost of production, normal value, by product type, was calculated as the weighted average of the actual domestic prices of all sales of the type in question, irrespective of whether those sales were profitable or not.

               (14)

               Where the volume of profitable sales of a product type represented 80 % or less of the total sales volume of that type, or where the weighted average price of that type was below the unit cost of production, normal value was based on the actual domestic price, which was calculated as a weighted average price of only the profitable domestic sales of that type made during the IP.

               (15)

               Wherever domestic prices of a particular product type sold by EGI could not be used in order to establish normal value, the normal value was constructed in accordance with Article 2(3) of the basic Regulation.

               (16)

               When constructing normal value pursuant to Article 2(3) of the basic Regulation, the amounts for selling, general and administrative costs and for profits have been based, pursuant to Article 2(6), chapeau, of the basic Regulation, on the actual data pertaining to the production and sales, in the ordinary course of trade, of the like product, by EGI.

               (17)

               Following disclosure of the findings, EGI claimed that the percentage rate for selling, general and administrative costs, which was used when constructing normal value, did not correspond to that in respect of domestic sales made in the ordinary course of trade and that, consequently, certain constructed normal values were overstated in this respect.

               (18)

               The claim was examined, but it was found to have no basis since the percentage rate for selling, general and administrative costs used is that reported for domestic sales and is the same irrespective of whether or not sales are made in the ordinary course of trade, since it is expressed as a percentage on turnover. The claim is therefore rejected.

         2.2.   Export price

               (19)

               EGI made export sales to the Union either directly to independent customers or through its related company EGS, located in Switzerland.

               (20)

               Where export sales to the Union were made directly to independent customers in the Union, export prices were established on the basis of the prices actually paid or payable for the product concerned in accordance with Article 2(8) of the basic Regulation.

               (21)

               Where export sales to the Union were made through the related company, EGS, which performed all import functions in relation to the goods entering into free circulation in the Union, i.e. that of a related importer, the export price was established in accordance with Article 2(9) of the basic Regulation, on the basis of prices at which the imported products were first resold to an independent buyer. For this purpose, adjustments were made to take account of all costs, incurred between importation and resale, and for profits accruing, so that a reliable export price could be established. For this purpose, in the absence of new information from independent importers concerning profits accruing, use was made of the same percentage profit as that used in the original investigation.

               (22)

               EGI claimed, under Article 11(10) of the basic Regulation, that, if the export price is established in accordance with Article 2(9) of the basic Regulation, the anti-dumping duty paid should not be deducted as a cost, since, they argued, it is duly reflected in resale prices.

               (23)

               In this regard, the evidence in support of the claim, which consisted of a number of selling price calculations, was examined. However, the calculations provided only concerned some of the models sold during the IP and showed that the selling price did not fully reflect the anti-dumping duty in all cases. Consequently, the evidence provided was not found to be conclusive on whether the anti-dumping duty was reflected in the resale prices. The claim was therefore rejected and, when establishing the export price for sales to the Union made through EGS in accordance with Article 2(9) of the basic Regulation, the anti-dumping duty was deducted as a cost.

               (24)

               Following disclosure of the findings, EGI repeated their claim. However, no new evidence or arguments in support of that claim were submitted. The claim is therefore rejected.

         2.3.   Comparison

               (25)

               The normal value and the export price were compared on an ex-works basis. For the purpose of ensuring a fair comparison between the normal value and export price, due allowance in the form of adjustments was made for transport costs, packing costs, credit costs, and commissions, where applicable and justified, in accordance with Article 2(10) of the basic Regulation.

               (26)

               Following disclosure of the findings, a calculation error involving the incorrect currency conversion of certain allowances for packing costs was brought to light. This was corrected and the dumping margin calculation was revised accordingly.

               (27)

               Also, following the disclosure of findings, EGI claimed that when constructing normal value, the allowances reported in respect of domestic sales which are not in the ordinary course of trade, should be disregarded and, in the absence of other sales of the product type in question, use should be made of the average allowances for sales of other product types made in the ordinary course of trade, because only the latter would reflect the costs which had been included in the selling, general and administrative costs used to construct the normal value.

               (28)

               This claim was examined, but was not accepted since, as allowances are used for comparison purposes only and normally reflect the actual costs specific to each transaction, they are an objective element and are therefore independent of whether or not sales are finally made in the ordinary course of trade.

               (29)

               Moreover, while examining this claim, it was found that incorrect allowances had been used when constructing normal values in the case of those product types for which there were no domestic sales. This was corrected by using the overall average allowances of all domestic sales, and the calculation was amended accordingly. EGI claimed that allowances for credit costs should be granted for these product types, since credit costs were included in the selling, general and administrative costs used in constructing the normal value. This claim was rejected because the product types in question were never actually sold on the domestic market and there was therefore no evidence that their payment would be deferred. In this respect, it is noted that a credit cost allowance is not based on actual payment terms and costs, but on an opportunity cost based on the payment terms agreed at the time of sale.

         2.4.   Dumping margin

               (30)

               As provided for under Article 2(11) of the basic Regulation, the weighted average normal value by type was compared with the weighted average export price of the corresponding type of the product concerned. This comparison showed the existence of dumping.

               (31)

               The dumping margin for EGI, expressed as a percentage of the net, free-at-Union-frontier price, duty unpaid, is 7 %.

               (32)

               In accordance with Article 11(3) of the basic Regulation, it was also examined whether the findings could reasonably be considered to be of a lasting nature.

               (33)

               The structural reorganisation of the sales channels of the applicant and its related company is now well established for the majority of its sales and can be considered long-lasting. Thus, the circumstances that led to the initiation of this interim review are unlikely to change in the foreseeable future in a manner that would affect the findings of the interim review. Furthermore, no element emerged in the course of the investigation that would suggest that the new circumstances are not lasting. Therefore, it is concluded that the changed circumstances are of a lasting nature.

         3.   ANTI-DUMPING MEASURES

               (34)

               In the original investigation EGI was found to be the sole Ukrainian exporting producer of ironing boards. The methodology used to determine the dumping margin for EGI was therefore used to establish the dumping margin for any other Ukrainian exporting producers of the product concerned.

               (35)

               Consequently in the light of the results of the review investigation, it is considered appropriate to amend the anti-dumping duty applicable to imports of the product concerned originating in Ukraine to 7 %.

               (36)

               Interested parties were informed of the essential facts and considerations on the basis of which it would be proposed to amend Council Regulation (EC) No 452/2007 imposing an anti-dumping duty on imports of the product concerned originating, inter alia, in Ukraine and were given an opportunity to comment. Their comments have been taken into account where appropriate and are duly reflected in this Regulation,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The entry concerning all companies in Ukraine in the table in Article 1(2) of Regulation (EC) No 452/2007 shall be replaced by the following:

                  ‘Ukraine

                  All companies

                  7

                  —’

   Article 2
   This Regulation shall enter into force on the 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 Luxembourg, 29 June 2010.

            For the Council

            The President

         E. ESPINOSA

      (1)  OJ L 343, 22.12.2009, p. 51.

      (2)  OJ L 109, 26.4.2007, p. 12.

      (3)  OJ C 85, 9.4.2009, p. 28.