title: Commission Implementing Regulation (EU) No 159/2013 of 21 February 2013 concerning the authorisation of a preparation of sodium benzoate, propionic acid and sodium propionate as a feed additive for pigs, poultry, bovines, sheep, goats, rabbits and horses and amending Regulations (EC) No 1876/2006 and (EC) No 757/2007  Text with EEA relevance

text:
               22.2.2013

               EN

               Official Journal of the European Union

               L 49/47

         COMMISSION IMPLEMENTING REGULATION (EU) No 159/2013
   of 21 February 2013
   concerning the authorisation of a preparation of sodium benzoate, propionic acid and sodium propionate as a feed additive for pigs, poultry, bovines, sheep, goats, rabbits and horses and amending Regulations (EC) No 1876/2006 and (EC) No 757/2007
   (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)

               A preparation of sodium benzoate, propionic acid and sodium propionate was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use on pigs and dairy cows by Commission Regulation (EC) No 1876/2006 (3) and for cattle for fattening by Commission Regulation (EC) No 757/2007 (4). That preparation 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 that preparation of sodium benzoate, propionic acid and sodium propionate as a feed additive for pigs and dairy cows and cattle for fattening and, in accordance with Article 7 of that Regulation, for a new use for pigs, poultry, bovines, sheep, goats, rabbits and horses, requesting that additive to be classified in the additive category ‘technological additives’. 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 opinions of 6 September 2011 (5) and 24 April 2012 (6) that, under the proposed conditions of use, the preparation of sodium benzoate, propionic acid and sodium propionate does not have an adverse effect on animal health, human health provided that adequate measures to protect users are taken, or the environment, and that it is efficacious in preserving cereals and complete feedingstuff. 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 sodium benzoate, propionic acid and sodium propionate 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.

               (6)

               As a consequence of the granting of a new authorisation under Regulation (EC) No 1831/2003, Regulations (EC) No 1876/2006 and (EC) No 757/2007 should therefore 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 the Food Chain and Animal Health,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Authorisation
   The preparation specified in the Annex, belonging to the additive category ‘technological additives’ and to the functional group ‘preservatives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
   Article 2
   Amendments to Regulation (EC) No 1876/2006
   Article 4 of Regulation (EC) No 1876/2006 and Annex IV thereto are deleted.
   Article 3
   Amendments to Regulation (EC) No 757/2007
   Article 1 of Regulation (EC) No 757/2007 and Annex I thereto are deleted.
   Article 4
   Transitional measures
   The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 14 September 2013 in accordance with the rules applicable before 14 March 2013 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, 21 February 2013.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ L 270, 14.12.1970, p. 1.

      (3)  OJ L 360, 19.12.2006, p. 126.

      (4)  OJ L 172, 30.6.2007, p. 43.

      (5)  EFSA Journal 2011; 9(9):2357.

      (6)  EFSA Journal 2012; 10(5):2681.

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

                     Category of technological additives. Functional group: preservatives

                  1a700

                  —

                  Preparation of sodium benzoate, propionic acid and sodium propionate

                                 Additive composition

                              Preparation of:

                                          sodium benzoate: 140 g/kg,

                                          propionic acid: 370 g/kg

                                          sodium propionate: 110 g/kg

                                          Water: 380 g/kg

                                 Characterisation of the active substances

                                          Sodium benzoate (C7H5O2Na) ≥ 99 % after drying of two hours at 105 °C

                                          Propionic acid (C3H6O2) ≥ 99,5 %

                                          Sodium propionate (C3H5O2Na) ≥ 99 % after drying of four hours at 105 °C

                                 Analytical method
                                  (1)

                              Quantification in feed additive:

                                          —

                                          determination of benzoate: reversed phase chromatography with UV detection (HPLC-UV)

                                          —

                                          total propionate: ion exclusion High Performance Liquid Chromatography with refractive index (HPLC-RI)

                                          —

                                          total sodium: atomic absorption spectrometry, AAS (EN ISO 6869)

                  Pigs
                  Poultry
                  Bovines
                  Sheep
                  Goats
                  Rabbits
                  Horses

                  —

                  —

                  10 000

                              1.

                              Simultaneous use with other sources of the active substances shall not exceed the authorised maximum content.

                              2.

                              Minimum content:

                                          —

                                          cereals with a moisture ≥ 15 % other than maize kernels: 3 000 mg/kg of cereals;

                                          —

                                          maize kernels with a moisture ≥ 15 %: 13 000 mg/kg of maize kernels;

                                          —

                                          complete feed with a moisture ≥ 12 %: 5 000 mg/kg of complete feed.

                              3.

                              Maximum content in all cereals: 22 000 mg/kg of cereals.

                              4.

                              For safety: it is recommended to use breathing and eyes protections and gloves during handling.

                  14 March 2023

         (1)  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) No 105/2013 of 4 February 2013 amending Implementing Regulation (EU) No 371/2011 as regards the name of the holder of the authorisation of dimethylglycine sodium salt  Text with EEA relevance

text:
               5.2.2013

               EN

               Official Journal of the European Union

               L 34/15

         COMMISSION IMPLEMENTING REGULATION (EU) No 105/2013
   of 4 February 2013
   amending Implementing Regulation (EU) No 371/2011 as regards the name of the holder of the authorisation of dimethylglycine sodium salt
   (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 13(3) thereof,
   Whereas:

               (1)

               Taminco N.V. has submitted an application under Article 13(3) of Regulation (EC) No 1831/2003 proposing to change the name of the holder of the authorisation as regards Commission Implementing Regulation (EU) No 371/2011 (2) concerning the 10 year authorisation of dimethylglycine sodium salt, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’.

               (2)

               The applicant claims that it transformed its legal form into a private limited liability company with effect from 1 October 2012. The applicant has submitted relevant data supporting its request.

               (3)

               The proposed change of the terms of the authorisation is purely administrative in nature and does not entail a fresh assessment of the additive concerned. The European Food Safety Authority was informed of the application.

               (4)

               To allow the applicant to exploit its marketing rights under the name of Taminco BVBA it is necessary to change the terms of the authorisation.

               (5)

               Implementing Regulation (EU) No 371/2011 should therefore be amended accordingly.

               (6)

               Since safety reasons do not require the immediate application of the amendment made by this Regulation to Implementing Regulation (EU) No 371/2011, it is appropriate to provide for a transitional period during which existing stocks may be used up.

               (7)

               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
   In column 2 of the Annex to Implementing Regulation (EU) No 371/2011 the words ‘Taminco N.V.’ are replaced by ‘Taminco BVBA’.
   Article 2
   Existing stocks of the additive which are in conformity with the provisions applying before the date of entry into force of this Regulation may continue to be placed on the market and used until they are exhausted.
   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, 4 February 2013.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ L 102, 16.4.2011, p. 6.


title: Commission Implementing Regulation (EU) No 467/2011 of 13 May 2011 fixing the import duties in the cereals sector applicable from 16 May 2011

text:
               14.5.2011

               EN

               Official Journal of the European Union

               L 125/12

         COMMISSION IMPLEMENTING REGULATION (EU) No 467/2011
   of 13 May 2011
   fixing the import duties in the cereals sector applicable from 16 May 2011
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
   Having regard to Commission Regulation (EU) No 642/2010 of 20 July 2010 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of import duties in the cereals sector (2), and in particular Article 2(1) thereof,
   Whereas:

               (1)

               Article 136(1) of Regulation (EC) No 1234/2007 states that the import duty on products falling within CN codes 1001 10 00, 1001 90 91, ex 1001 90 99 (high quality common wheat), 1002, ex 1005 other than hybrid seed, and ex 1007 other than hybrids for sowing, is to be equal to the intervention price valid for such products on importation increased by 55 %, minus the cif import price applicable to the consignment in question. However, that duty may not exceed the rate of duty in the Common Customs Tariff.

               (2)

               Article 136(2) of Regulation (EC) No 1234/2007 lays down that, for the purposes of calculating the import duty referred to in paragraph 1 of that Article, representative cif import prices are to be established on a regular basis for the products in question.

               (3)

               Pursuant to Article 2(2) of Regulation (EU) No 642/2010, the price to be used for the calculation of the import duty on products of CN codes 1001 10 00, 1001 90 91, ex 1001 90 99 (high quality common wheat), 1002 00, 1005 10 90, 1005 90 00 and 1007 00 90 is the daily cif representative import price determined as specified in Article 5 of that Regulation.

               (4)

               Import duties should be fixed for the period from 16 May 2011 and should apply until new import duties are fixed and enter into force,

         HAS ADOPTED THIS REGULATION:
   Article 1
   From 16 May 2011, the import duties in the cereals sector referred to in Article 136(1) of Regulation (EC) No 1234/2007 shall be those fixed in Annex I to this Regulation on the basis of the information contained in Annex II.
   Article 2
   This Regulation shall enter into force on 16 May 2011.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 13 May 2011.

            For the Commission, On behalf of the President,

         José Manuel SILVA RODRÍGUEZ

            Director-General for Agriculture and Rural Development

      (1)  OJ L 299, 16.11.2007, p. 1.

      (2)  OJ L 187, 21.7.2010, p. 5.

      ANNEX I

         Import duties on the products referred to in Article 136(1) of Regulation (EC) No 1234/2007 applicable from 16 May 2011

                  CN code

                  Description

                  Import duties (1)

                  (EUR/t)

                  1001 10 00

                  Durum wheat, high quality

                  0,00

                  medium quality

                  0,00

                  low quality

                  0,00

                  1001 90 91

                  Common wheat seed

                  0,00

                  ex 1001 90 99

                  High quality common wheat, other than for sowing

                  0,00

                  1002 00 00

                  Rye

                  0,00

                  1005 10 90

                  Maize seed, other than hybrid

                  0,00

                  1005 90 00

                  Maize, other than seed (2)

                  0,00

                  1007 00 90

                  Grain sorghum, other than hybrids for sowing

                  0,00

         (1)  For goods arriving in the Union via the Atlantic Ocean or via the Suez Canal the importer may benefit, persuant to Article 2(4) of Regulation (EU) No 642/2010, from a reduction in the duty of:

                  —

                  3 EUR/t, where the port of unloading is on the Mediterranean Sea, or on the Black Sea,

                  —

                  2 EUR/t, where the port of unloading is in Denmark, Estonia, Ireland, Latvia, Lithuania, Poland, Finland, Sweden, the United Kingdom, or on the Atlantic coast of the Iberian peninsula.

         (2)  The importer may benefit from a flatrate reduction of EUR 24 per tonne where the conditions laid down in Article 3 of Regulation (EU) No 642/2010 are met.

      ANNEX II

         Factors for calculating the duties laid down in Annex I

      29.4.2011-12.5.2011

                  1.

                  Averages over the reference period referred to in Article 2(2) of Regulation (EU) No 642/2010:

                              (EUR/t)

                              Common wheat (1)

                              Maize

                              Durum wheat, high quality

                              Durum wheat, medium quality (2)

                              Durum wheat, low quality (3)

                              Barley

                              Exchange

                              Minnéapolis

                              Chicago

                              —

                              —

                              —

                              —

                              Quotation

                              247,86

                              192,42

                              —

                              —

                              —

                              —

                              Fob price USA

                              —

                              —

                              255,38

                              245,38

                              225,38

                              164,90

                              Gulf of Mexico premium

                              —

                              15,33

                              —

                              —

                              —

                              —

                              Great Lakes premium

                              71,88

                              —

                              —

                              —

                              —

                              —

                  2.

                  Averages over the reference period referred to in Article 2(2) of Regulation (EU) No 642/2010:

                              Freight costs: Gulf of Mexico–Rotterdam:

                              16,82 EUR/t

                              Freight costs: Great Lakes–Rotterdam:

                              47,76 EUR/t

         (1)  Premium of 14 EUR/t incorporated (Article 5(3) of Regulation (EU) No 642/2010).

         (2)  Discount of 10 EUR/t (Article 5(3) of Regulation (EU) No 642/2010).

         (3)  Discount of 30 EUR/t (Article 5(3) of Regulation (EU) No 642/2010).


title: Commission Implementing Regulation (EU) No 52/2013 of 22 January 2013 amending Annex XIb to Council Regulation (EC) No 1234/2007 as regards semi-sparkling wine, aerated semi-sparkling wine and rectified concentrated grape must

text:
               23.1.2013

               EN

               Official Journal of the European Union

               L 20/44

      COMMISSION IMPLEMENTING REGULATION (EU) No 52/2013
   of 22 January 2013
   amending Annex XIb to Council Regulation (EC) No 1234/2007 as regards semi-sparkling wine, aerated semi-sparkling wine and rectified concentrated grape must
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (‘Single CMO’ Regulation) (1), and in particular paragraph 2 of Article 113d thereof,
   Whereas:

               (1)

               In accordance with Article 113d of Regulation (EC) No 1234/2007, Annex XIb to that Regulation lists the categories of grapevine products that may be used in the Union for the marketing of a product which conforms to the conditions laid down in that Annex.

               (2)

               As regards semi-sparkling wine and aerated semi-sparkling wine, points 8 and 9 of Annex XIb to Regulation (EC) No 1234/2007 stipulate that these wines should be obtained from wine. However, pursuant to points 17 and 18 of Annex I to Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine (2), these products may also be obtained from other products suitable for yielding wine. The reform of the wine sector introduced by Council Regulation (EC) No 479/2008 (3) was not intended to amend the list of products used to obtain semi-sparkling wine or aerated semi-sparkling wine. It is therefore necessary to stipulate again that semi-sparkling wine and aerated semi-sparkling wine may also be obtained from new wine still in fermentation, grape must or grape must in fermentation.

               (3)

               New procedures for producing rectified concentrated grape must make it possible to obtain crystallised rectified concentrated must. The definition of rectified concentrated grape must set out in point 14 of Annex XIb to Regulation (EC) No 1234/2007 provides only for a liquid form. The definition of rectified concentrated grape must should be adapted in order to include the crystallised form.

               (4)

               Annex XIb to Regulation (EC) No 1234/2007 should therefore be amended accordingly.

               (5)

               The measures provided for in this Regulation are in accordance with the opinion of the Regulatory Committee established by Article 195(3) of Regulation (EC) No 1234/2007,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex XIb to Regulation (EC) No 1234/2007 is amended as follows:

               1.

               Point 8(a) is replaced by the following:

                           ‘(a)

                           obtained from wine, new wine still in fermentation, grape must or grape must in fermentation in so far as these products have a total alcohol strength of at least 9 % vol;’.

               2.

               Point 9(a) is replaced by the following:

                           ‘(a)

                           obtained from wine, new wine still in fermentation, grape must or grape must in fermentation;’.

               3.

               Point 14 is replaced by:
               ‘14.   Rectified concentrated grape must

               ‘Rectified concentrated grape must’ means:

                           (a)

                           the liquid uncaramelised product which:

                                       (i)

                                       is obtained by partial dehydration of grape must carried out by any authorised method other than direct heat in such a way that the figure indicated by a refractometer used according to a method to be prescribed in accordance with Article 120g at a temperature of 20 °C is not less than 61,7 %;

                                       (ii)

                                       has undergone authorised treatment for de-acidification and elimination of constituents other than sugar;

                                       (iii)

                                       has the following characteristics:

                                                   —

                                                   a pH of not more than 5 at 25 °Brix,

                                                   —

                                                   an optical density at 425 nm for a thickness of 1 cm of not more than 0,100 in grape must concentrated at 25 °Brix,

                                                   —

                                                   a sucrose content undetectable by a method of analysis to be defined,

                                                   —

                                                   a Folin-Ciocalteu index of not more than 6,00 at 25 °Brix,

                                                   —

                                                   a titratable acidity of not more than 15 millequivalents per kilogram of total sugars,

                                                   —

                                                   a sulphur dioxide content of not more than 25 milligrams per kilogram of total sugars,

                                                   —

                                                   a total cation content of not more than 8 millequivalents per kilogram of total sugars,

                                                   —

                                                   a conductivity at 25 °Brix and 20 °C of not more than 120 micro-Siemens/cm,

                                                   —

                                                   a hydroxymethylfurfural content of not more than 25 milligrams per kilogram of total sugars,

                                                   —

                                                   presence of mesoinositol;

                           b)

                           the solid uncaramelised product which:

                                       (i)

                                       is obtained by crystallisation of liquid rectified concentrated grape must without the use of solvents;

                                       (ii)

                                       has undergone authorised treatment for de-acidification and elimination of constituents other than sugar;

                                       (iii)

                                       has the following characteristics after dilution in a solution at 25 °Brix:

                                                   —

                                                   a pH of not more than 7,5,

                                                   —

                                                   an optical density at 425 nm for a thickness of 1 cm of not more than 0,100,

                                                   —

                                                   a sucrose content undetectable by a method of analysis to be defined,

                                                   —

                                                   a Folin-Ciocalteu index of not more than 6,00,

                                                   —

                                                   a titratable acidity of not more than 15 millequivalents per kilogram of total sugars,

                                                   —

                                                   a sulphur dioxide content of not more than 10 milligrams per kilogram of total sugars,

                                                   —

                                                   a total cation content of not more than 8 millequivalents per kilogram of total sugars,

                                                   —

                                                   a conductivity at 20 °C of not more than 120 micro-Siemens/cm,

                                                   —

                                                   a hydroxymethylfurfural content of not more than 25 milligrams per kilogram of total sugars,

                                                   —

                                                   presence of mesoinositol.

                     An actual alcoholic strength of the rectified concentrated grape must of not more than 1 % volume is permissible’.

         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, 22 January 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 299, 16.11.2007, p. 1.

      (2)  OJ L 179, 14.7.1999, p. 1.

      (3)  OJ L 148, 6.6.2008, p. 1.


title: Commission Implementing Regulation (EU) No 167/2012 of 24 February 2012 fixing the maximum amount of aid granted for the private storage of olive oil under the tendering procedure opened by Implementing Regulation (EU) No 111/2012

text:
               25.2.2012

               EN

               Official Journal of the European Union

               L 53/12

         COMMISSION IMPLEMENTING REGULATION (EU) No 167/2012
   of 24 February 2012
   fixing the maximum amount of aid granted for the private storage of olive oil under the tendering procedure opened by Implementing Regulation (EU) No 111/2012
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 43(d) in conjunction with Article 4 thereof,
   Whereas:

               (1)

               Commission Implementing Regulation (EU) No 111/2012 of 9 February 2012 opening the tendering procedure for aid for private storage of olive oil (2) provides for two tendering sub-periods.

               (2)

               Under Article 13(1) of Commission Regulation (EC) No 826/2008 of 20 August 2008 laying down common rules for the granting of private storage aid for certain agricultural products (3), on the basis of the tenders notified by the Member States the Commission is to decide whether or not to fix a maximum amount of aid.

               (3)

               On the basis of the tenders submitted in response to the first partial invitation to tender, a maximum amount of aid for private storage of olive oil should be fixed for the tendering sub-period ending on 21 February 2012. The fixing of such a maximum amount of aid would lead to the global quantity provided for in Article 1(2) of Implementing Regulation (EU) No 111/2012 being exceeded. Consequently, in accordance with Article 13(2) of Regulation (EC) No 826/2008, the Commission is fixing an allocation coefficient for tenders which have been introduced at the maximum aid level in order to comply with the global quantity laid down.

               (4)

               In order to send the market a swift signal and ensure that the measure is managed efficiently, this Regulation should enter into force on the day of its publication in the Official Journal of the European Union.

               (5)

               The Management Committee for the Common Organisation of Agricultural Markets has not delivered an opinion within the time limit set by its Chair,

         HAS ADOPTED THIS REGULATION:
   Article 1
   1.   For the tendering sub-period ending on 21 February 2012 under the tendering procedure opened by Implementing Regulation (EU) No 111/2012, the maximum amount of aid for olive oil is hereby fixed in accordance with the Annex to this Regulation.
   2.   An allocation coefficient of 84,00456 % shall apply to tenders introduced at the maximum aid level.
   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, 24 February 2012.

            For the Commission, On behalf of the President,
         José Manuel SILVA RODRÍGUEZ

            Director-General for Agriculture and Rural Development

      (1)  OJ L 299, 16.11.2007, p. 1.

      (2)  OJ L 37, 10.2.2012, p. 55.

      (3)  OJ L 223, 21.8.2008, p. 3.

      ANNEX

                  Product

                  Maximum amount of aid
                  (EUR/tonne/day)

                  Extra virgin olive oil

                  0,00

                  Virgin olive oil

                  0,65


title: Commission Implementing Regulation (EU) No 470/2013 of 22 May 2013 opening a tariff quota for certain quantities of industrial sugar for the 2013/14 marketing year

text:
               23.5.2013

               EN

               Official Journal of the European Union

               L 136/9

         COMMISSION IMPLEMENTING REGULATION (EU) No 470/2013
   of 22 May 2013
   opening a tariff quota for certain quantities of industrial sugar for the 2013/14 marketing year
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 142, in conjunction with Article 4 thereof,
   Whereas:

               (1)

               In order to ensure that the supply necessary for the production of the products referred to in Article 62(2) of Regulation (EC) No 1234/2007 is available at a price that corresponds to the world price, it is in the interest of the Union to suspend the import duties on sugar intended for the production of those products for the 2013/14 marketing year, for a quantity that would correspond to half of its industrial sugar needs.

               (2)

               Commission Regulation (EC) No 891/2009 of 25 September 2009 opening and providing for the administration of certain Community tariff quotas in the sugar sector (2) provides for the administration of the tariff quotas for imports of sugar products under Article 142 of Regulation (EC) No 1234/2007 with order number 09.4390 (industrial import sugar). However, in accordance with Article 11 of Regulation (EC) No 891/2009 the quantities of those products for which import duties are to be suspended has to be determined by a separate legal act.

               (3)

               The import quantities of industrial sugar for which no import duties should apply for the 2013/14 marketing year, need to be set accordingly.

               (4)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The import duties for industrial sugar falling within CN 1701 and with order number 09.4390 shall be suspended for a quantity of 400 000 tonnes from 1 October 2013 to 30 September 2014.
   Article 2
   This Regulation shall enter into force on the seventh day following that of its publication in the Official Journal of the European Union.
   It shall apply from 1 October 2013.
   It shall expire on 30 September 2014.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 22 May 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 299, 16.11.2007, p. 1.

      (2)  OJ L 254, 26.9.2009, p. 82.


title: Commission Implementing Regulation (EU) No 675/2013 of 15 July 2013 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications [Pomodoro di Pachino (PGI)]

text:
               17.7.2013

               EN

               Official Journal of the European Union

               L 194/1

         COMMISSION IMPLEMENTING REGULATION (EU) No 675/2013
   of 15 July 2013
   approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications [Pomodoro di Pachino (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)

               Regulation (EU) No 1151/2012 repealed and replaced Council Regulation (EC) No 510/2006 of 20 March 2006 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (2).

               (2)

               In accordance with the first subparagraph of Article 9(1) of Regulation (EC) No 510/2006, the Commission has examined Italy’s application for the approval of amendments to the specification for the protected geographical indication ‘Pomodoro di Pachino’ registered under Commission Regulation (EC) No 617/2003 (3).

               (3)

               Since the amendments in question are not minor, the Commission published the amendment application in the Official Journal of the European Union
                   (4), as required by Article 6(2) of Regulation (EC) No 510/2006. As no statement of objection under Article 7 of that Regulation has been received by the Commission, the amendments to the specification should be approved,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The amendments to the specification published in the Official Journal of the European Union regarding the name contained in the Annex to this Regulation are hereby approved.
   Article 2
   This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 15 July 2013.

            For the Commission, On behalf of the President,
         Dacian CIOLOȘ

            Member of the Commission

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

      (2)  OJ L 93, 31.3.2006, p. 12.

      (3)  OJ L 89, 5.4.2003, p. 3.

      (4)  OJ C 308, 12.10.2012, p. 17.

      ANNEX
      Agricultural products intended for human consumption listed in Annex I to the Treaty:

         Class 1.6.   Fruit, vegetables and cereals, fresh or processed

      ITALY
      Pomodoro di Pachino (PGI)


title: Commission Implementing Regulation (EU) No 586/2011 of 17 June 2011 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               18.6.2011

               EN

               Official Journal of the European Union

               L 160/80

         COMMISSION IMPLEMENTING REGULATION (EU) No 586/2011
   of 17 June 2011
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
   Having regard to Commission Regulation (EC) No 1580/2007 of 21 December 2007 laying down implementing rules for Council Regulations (EC) No 2200/96, (EC) No 2201/96 and (EC) No 1182/2007 in the fruit and vegetable sector (2), and in particular Article 138(1) thereof,
   Whereas:
   Regulation (EC) No 1580/2007 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XV, Part A thereto,
   HAS ADOPTED THIS REGULATION:
   Article 1
   The standard import values referred to in Article 138 of Regulation (EC) No 1580/2007 are fixed in the Annex hereto.
   Article 2
   This Regulation shall enter into force on 18 June 2011.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 17 June 2011.

            For the Commission, On behalf of the President,

         José Manuel SILVA RODRÍGUEZ

            Director-General for Agriculture and Rural Development

      (1)  OJ L 299, 16.11.2007, p. 1.

      (2)  OJ L 350, 31.12.2007, p. 1.

      ANNEX
      Standard import values for determining the entry price of certain fruit and vegetables

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  MA

                  57,8

                  MK

                  31,8

                  TR

                  54,0

                  ZZ

                  47,9

                  0707 00 05

                  TR

                  97,3

                  ZZ

                  97,3

                  0709 90 70

                  TR

                  111,4

                  ZZ

                  111,4

                  0805 50 10

                  AR

                  65,2

                  BR

                  40,6

                  TR

                  76,6

                  ZA

                  100,1

                  ZZ

                  70,6

                  0808 10 80

                  AR

                  90,6

                  BR

                  79,3

                  CL

                  84,5

                  CN

                  80,6

                  NZ

                  97,4

                  UY

                  98,4

                  ZA

                  85,5

                  ZZ

                  88,0

                  0809 10 00

                  TR

                  158,2

                  ZZ

                  158,2

                  0809 20 95

                  TR

                  385,5

                  XS

                  175,4

                  ZZ

                  280,5

         (1)  Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ZZ’ stands for ‘of other origin’.


title: Commission Implementing Regulation (EU) 2016/1439 of 18 August 2016 entering a name in the register of protected designations of origin and protected geographical indications (Oriel Sea Salt (PDO))

text:
               31.8.2016

               EN

               Official Journal of the European Union

               L 234/9

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/1439
   of 18 August 2016
   entering a name in the register of protected designations of origin and protected geographical indications (Oriel Sea Salt (PDO))
   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, Ireland's application to register the name ‘Oriel Sea Salt’ 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 ‘Oriel Sea Salt’ should therefore be entered in the register,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The name ‘Oriel Sea Salt’ (PDO) is hereby entered in the register.
   The name specified in the first paragraph denotes a product in Class 2.6. Salt, 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, 18 August 2016.

            For the Commission,

            On behalf of the President,

         Carlos MOEDAS

            Member of the Commission

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

      (2)  OJ C 141, 22.4.2016, p. 21.

      (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 844/2011 of 23 August 2011 approving the pre-export checks carried out by Canada on wheat and wheat flour as regards the presence of ochratoxin A  Text with EEA relevance

text:
               24.8.2011

               EN

               Official Journal of the European Union

               L 218/4

         COMMISSION IMPLEMENTING REGULATION (EU) No 844/2011
   of 23 August 2011
   approving the pre-export checks carried out by Canada on wheat and wheat flour as regards the presence of ochratoxin A
   (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 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (1), and in particular Article 23 thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (2) lays down permitted maximum levels of ochratoxin A in foodstuffs. Only foodstuffs complying with the maximum level may be placed on the Union market.

               (2)

               Regulation (EC) No 882/2004 provides an obligation for the Member States to ensure that official controls are carried out regularly, on a risk basis and with appropriate frequency in order to achieve the objectives of the Regulation, which are inter alia preventing, eliminating or reducing to acceptable levels risks to humans and animals.

               (3)

               Article 23 of Regulation (EC) No 882/2004 provides that specific pre-export checks that a third country carries out on feed and food immediately prior to export to the European Union with a view to verifying that the exported products satisfy Union requirements may be approved.

               (4)

               Such an approval may only be granted to a third country if an European Union audit has shown that feed or food exported to the European Union meets Union requirements or equivalent requirements and that the controls carried out in the third country prior to dispatch are considered sufficiently effective and efficient as to replace or reduce the documentary, identity and physical checks laid down in Union law.

               (5)

               On 8 October 2007 Canada has submitted to the Commission an application for obtaining an approval of the pre-export checks performed by the competent authorities of Canada on the ochratoxin A contamination in wheat (common and durum) and wheat flour intended for export to the European Union.

               (6)

               The Commission has assessed in detail the information provided by the Canadian Grain Commission, the competent authority of Canada under the responsibility of which the pre-export checks will be performed, and considers that the guarantees provided are satisfactory and justify the approval of the pre-export checks on wheat and wheat flour as regards the presence of ochratoxin A.

               (7)

               It is therefore appropriate to grant approval of pre-export checks carried out by Canada on wheat and wheat flour ensuring compliance with the maximum levels of ochratoxin A laid down in Union law.

               (8)

               According to Article 16(2) of Regulation (EC) No 882/2004 Member States are required to adjust the frequency of physical checks on imports to the risk associated with different categories of food and taking into account, among other things, the guarantees provided by the competent authorities of the third country of origin of the food in question. Systematic pre-export checks carried out under the authority of the Canadian Grain Commission in conformity with the Union approval and in accordance with Article 23 of Regulation 882/2004 provide a satisfactory level of guarantees in relation to the ochratoxin A contamination in wheat and wheat flour and therefore allow Member States to reduce the frequency of physical checks performed on those commodities.

               (9)

               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
   Approval of pre-export checks
   Pre-export checks as regards the presence of ochratoxin A, carried out by the Canadian Grain Commission immediately prior to export to the European Union, are approved for the following foodstuffs

               (a)

               wheat falling within HS/CN code 1001, produced on the territory of Canada, and

               (b)

               wheat flour falling within HS/CN code 1101 00, produced on the territory of Canada.

         Article 2
   Conditions for approval of pre-export checks
   1.   Each consignment of products referred to in Article 1 shall be accompanied by:

               (a)

               a report containing the results of sampling and analysis performed in accordance with the provisions of Commission Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official control of mycotoxins in foodstuffs (3), or with equivalent requirements, by a laboratory approved for that purpose by the Canadian Grain Commission;

               (b)

               a certificate in accordance with the model set out in the Annex, completed, verified and signed by a representative of the Canadian Grain Commission; the certificate shall be valid for four months from the date of issuance.

         2.   The report and certificate referred to in paragraph 1 may be provided electronically, after the practical modalities have been agreed upon.
   3.   Each consignment of foodstuffs shall bear an identification code which shall be reproduced on the report and on the certificate referred to in paragraph 1. Each individual bag, or other packaging form, of the consignment shall be identified with the same code.
   Article 3
   Splitting of consignments
   If a consignment is split, copies of the certificate provided for in Article 2 (1) (b) and certified by the competent authority of the Member State on whose territory the splitting has taken place, shall accompany each part of the split consignment until it is released for free circulation.
   Article 4
   Official controls
   In accordance with the provisions of Article 16 (2) and Article 23(2) of Regulation (EC) 882/2004, the frequency of the physical checks carried out by the Member States on consignments of products referred to in Article 1 shall be reduced to a maximum of 1 % of the number of consignments presented in accordance with Article 2.
   Article 5
   Entry into force
   This Regulation shall enter into force on the twentieth day following its publication in the Official Journal of the European Union.

   It shall apply from 1 October 2011.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 23 August 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 165, 30.4.2004, p. 1.

      (2)  OJ L 364, 20.12.2006, p. 5.

      (3)  OJ L 70, 9.3.2006, p. 12.

      ANNEX


title: Commission Implementing Regulation (EU) No 142/2013 of 19 February 2013 amending Regulation (EC) No 2535/2001 as regards the data relating to the body issuing certificates in New Zealand for the export of milk products

text:
               20.2.2013

               EN

               Official Journal of the European Union

               L 47/49

         COMMISSION IMPLEMENTING REGULATION (EU) No 142/2013
   of 19 February 2013
   amending Regulation (EC) No 2535/2001 as regards the data relating to the body issuing certificates in New Zealand for the export of milk products
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1), and in particular Article 144(1) and Article 148(c), in conjunction with Article 4 thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 2535/2001 of 14 December 2001 laying down detailed rules for applying Council Regulation (EC) No 1255/1999 as regards the import arrangements for milk and milk products and opening tariff quotas (2) lists in its Annex XII bodies responsible for issuing inward-monitoring arrangement (IMA 1) certificates.

               (2)

               New Zealand has communicated to the Commission a change, as from 1 March 2013, of the name and the location of the issuing body listed in that Annex. In view of that it is necessary to update the data relating to the issuing body in New Zealand listed in Annex XII to that Regulation.

               (3)

               Regulation (EC) No 2535/2001 should therefore be amended accordingly.

               (4)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex XII to Regulation (EC) No 2535/2001 is amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
   It shall apply to the IMA 1 certificates issued from 1 March 2013.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 19 February 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 299, 16.11.2007, p. 1.

      (2)  OJ L 341, 22.12.2001, p. 29.

      ANNEX
      In Annex XII to Regulation (EC) No 2535/2001, the entry for New Zealand is replaced by the following:

                     ‘New Zealand

                     ex 0405 10 11

                     Butter

                     Ministry for Primary Industries

                                 Pastoral House

                                 25 The Terrace

                                 PO Box 2526

                                 Wellington 6140

                                 Tel. +64 4 894 0100

                                 Fax + 64 4 894 0720

                                 www.mpi.govt.nz’

                     ex 0405 10 19

                     Butter

                     ex 0405 10 30

                     Butter

                     ex 0406 90 01

                     Cheese for processing

                     ex 0406 90 21

                     Cheddar


title: Commission Implementing Regulation (EU) No 292/2012 of 2 April 2012 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               3.4.2012

               EN

               Official Journal of the European Union

               L 96/3

         COMMISSION IMPLEMENTING REGULATION (EU) No 292/2012
   of 2 April 2012
   establishing the standard import values for determining the entry price of certain fruit and vegetables
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1234/2007 of 22 October 2007 establishing a common organisation of agricultural markets and on specific provisions for certain agricultural products (Single CMO Regulation) (1),
   Having regard to Commission Implementing Regulation (EU) No 543/2011 of 7 June 2011 laying down detailed rules for the application of Council Regulation (EC) No 1234/2007 in respect of the fruit and vegetables and processed fruit and vegetables sectors (2), and in particular Article 136(1) thereof,
   Whereas:

               (1)

               Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

               (2)

               The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore 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 standard import values referred to in Article 136 of Implementing Regulation (EU) No 543/2011 are fixed 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, 2 April 2012.

            For the Commission, On behalf of the President,
         José Manuel SILVA RODRÍGUEZ

            Director-General for Agriculture and Rural Development

      (1)  OJ L 299, 16.11.2007, p. 1.

      (2)  OJ L 157, 15.6.2011, p. 1.

      ANNEX
      Standard import values for determining the entry price of certain fruit and vegetables

                  (EUR/100 kg)

                  CN code

                  Third country code (1)

                  Standard import value

                  0702 00 00

                  CR

                  48,1

                  IL

                  107,9

                  MA

                  63,4

                  TN

                  96,3

                  TR

                  92,7

                  ZZ

                  81,7

                  0707 00 05

                  JO

                  225,1

                  TR

                  156,2

                  ZZ

                  190,7

                  0709 91 00

                  EG

                  76,0

                  ZZ

                  76,0

                  0709 93 10

                  JO

                  225,1

                  MA

                  44,5

                  TR

                  125,6

                  ZZ

                  131,7

                  0805 10 20

                  EG

                  49,2

                  IL

                  76,4

                  MA

                  49,9

                  TN

                  58,4

                  TR

                  64,8

                  ZA

                  45,1

                  ZZ

                  57,3

                  0805 50 10

                  MX

                  39,8

                  TR

                  45,2

                  ZZ

                  42,5

                  0808 10 80

                  AR

                  85,0

                  BR

                  85,4

                  CA

                  156,1

                  CL

                  99,1

                  CN

                  107,2

                  MA

                  49,8

                  MK

                  31,8

                  US

                  173,0

                  UY

                  74,3

                  ZA

                  74,7

                  ZZ

                  93,6

                  0808 30 90

                  AR

                  102,9

                  CL

                  105,9

                  CN

                  51,0

                  ZA

                  106,6

                  ZZ

                  91,6

         (1)  Nomenclature of countries laid down by Commission Regulation (EC) No 1833/2006 (OJ L 354, 14.12.2006, p. 19). Code ‘ZZ’ stands for ‘of other origin’.


title: Commission Implementing Regulation (EU) No 288/2013 of 25 March 2013 concerning the suspension of the authorisations of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as provided for by Regulations (EC) No 256/2002, (EC) No 1453/2004, (EC) No 255/2005, (EC) No 1200/2005, (EC) No 166/2008 and (EC) No 378/2009  Text with EEA relevance

text:
               26.3.2013

               EN

               Official Journal of the European Union

               L 86/15

         COMMISSION IMPLEMENTING REGULATION (EU) No 288/2013
   of 25 March 2013
   concerning the suspension of the authorisations of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as provided for by Regulations (EC) No 256/2002, (EC) No 1453/2004, (EC) No 255/2005, (EC) No 1200/2005, (EC) No 166/2008 and (EC) No 378/2009
   (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 13(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, denying or suspending 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 preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for use for piglets under two months and sows by Commission Regulation (EC) No 256/2002 (3), for piglets from two to four months and pigs for fattening by Commission Regulation (EC) No 1453/2004 (4), for cattle for fattening by Commission Regulation (EC) No 255/2005 (5) and for rabbits for fattening and chickens for fattening by Commission Regulation (EC) No 1200/2005 (6). The preparation was subsequently entered in the European Union Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

               (3)

               That preparation was also authorised in accordance with Regulation (EC) No 1831/2003 for 10 years for turkeys for fattening by Commission Regulation (EC) No 166/2008 (7) and for rabbit breeding does by Commission Regulation (EC) No 378/2009 (8).

               (4)

               In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the authorisation of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) as a feed additive for cattle for fattening, rabbits for fattening, chickens for fattening, piglets (weaned), pigs for fattening and sows for reproduction and, in accordance with Article 7 of that Regulation, an application was submitted for a new use of that preparation for calves for rearing, both applications requesting the additive to be classified in the additive category ‘zootechnical additives’. Those applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

               (5)

               The European Food Safety Authority (‘the Authority’) concluded in its opinion of 16 October 2012 (9) that the strain of Bacillus cereus harbours resistance determinants to two antibiotics used in human and veterinary medicine, one of which at least can now be ascribed to an acquired resistance. It was also determined that, because of the presence of genes having the same organisation as pathogenic Bacillus cereus strains, it has to be assumed that the Bacillus cereus strain contained in the preparation subject to the application has the capacity to elaborate functional toxins involved in foodborne diseases.

               (6)

               The information available does not allow one to exclude the risk that the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) may spread resistance to those antibiotics to other micro-organisms and may expose to the risk of the toxins those handling the additive or consumers. Consequently, it has not been established that that preparation does not have an adverse effect on animal health or on human health, when used under the proposed conditions.

               (7)

               The conclusions from the Authority concerning the safety of the preparation apply to its use for all the animal species for which an authorisation has been granted, including for turkeys for fattening and for rabbit breeding does, as authorised by Regulations (EC) No 166/2008 and (EC) No 378/2009.

               (8)

               Those authorisations therefore no longer meet the conditions set out by Article 5 of Regulation (EC) No 1831/2003.

               (9)

               It is possible that supplementary data concerning the safety of use of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) bring new elements that would allow a re-consideration of the assessment carried out for that additive. In this respect, the applicant for the authorisation of that preparation argues that new evidence may be provided in order to demonstrate the safety of the additive. To this end, the applicant committed itself to produce supplementary data which, it states, should be available by April 2013. Those data would consist of new studies supporting a new taxonomical classification of the micro-organism as a new Bacillus species, the non-transferability of the antibiotic resistance and the non-functionality of the enterotoxin genes present in the genome of Bacillus var. toyoi.

               (10)

               In accordance with Article 13(2) of Regulation (EC) No 1831/2003, the authorisations of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) provided for by Regulations (EC) No 256/2002, (EC) No 1453/2004, (EC) No 255/2005, (EC) No 1200/2005, (EC) No 166/2008 and (EC) No 378/2009 should therefore be suspended, pending the submission and assessment of the supplementary data. The suspension measure should be reviewed after due assessment of those data by the Authority.

               (11)

               Since further use of the preparation as a feed additive may cause a risk to human and animal health, respective products 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.

               (12)

               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
   Suspension of the authorisation provided for by Regulation (EC) No 256/2002
   The authorisation provided for by Regulation (EC) No 256/2002 concerning the preparation specified in entry E 1701 of Annex III to that Regulation is suspended.
   Article 2
   Suspension of the authorisation provided for by Regulation (EC) No 1453/2004
   The authorisation provided for by Regulation (EC) No 1453/2004 concerning the preparation specified in entry E 1701 of Annex I to that Regulation is suspended.
   Article 3
   Suspension of the authorisation provided for by Regulation (EC) No 255/2005
   The authorisation provided for by Regulation (EC) No 255/2005 concerning the preparation specified in entry E 1701 of Annex I to that Regulation is suspended.
   Article 4
   Suspension of the authorisation provided for by Regulation (EC) No 1200/2005
   The authorisation provided for by Regulation (EC) No 1200/2005 concerning the preparation specified in entry E 1701 of Annex II to that Regulation is suspended.
   Article 5
   Suspension of the authorisation provided for by Regulation (EC) No 166/2008
   The authorisation provided for in Article 1 of Regulation (EC) No 166/2008 is suspended.
   Article 6
   Suspension of the authorisation provided for by Regulation (EC) No 378/2009
   The authorisation provided for in Article 1 of Regulation (EC) No 378/2009 is suspended.
   Article 7
   Transitional measures
   Existing stocks of the preparation of Bacillus cereus var. toyoi (NCIMB 40112/CNCM I-1012) for use for cattle for fattening, rabbits for fattening, chickens for fattening, piglets, pigs for fattening, sows, turkeys for fattening and rabbit breeding does, and of premixtures containing that preparation, shall be withdrawn from the market by 14 June 2013. Feed materials and compound feed produced with that preparation or with premixtures containing that preparation before 14 June 2013 shall be withdrawn from the market by 15 October 2013.
   Article 8
   Review of the measure
   This Regulation shall be reviewed by 15 April 2015.
   Article 9
   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, 25 March 2013.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  OJ L 270, 14.12.1970, p. 1.

      (3)  OJ L 41, 13.2.2002, p. 6.

      (4)  OJ L 269, 17.8.2004, p. 3.

      (5)  OJ L 45, 16.2.2005, p. 3.

      (6)  OJ L 195, 27.7.2005, p. 6.

      (7)  OJ L 50, 23.2.2008, p. 11.

      (8)  OJ L 116, 9.5.2009, p. 3.

      (9)  EFSA Journal 2012; 10(10):2924.