title: Commission Implementing Regulation (EU) No 1070/2014 of 10 October 2014 amending Regulation (EC) No 271/2009 as regards the minimum content of the preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for laying hens (holder of authorisation BASF SE)  Text with EEA relevance

text:
               11.10.2014

               EN

               Official Journal of the European Union

               L 295/49

         COMMISSION IMPLEMENTING REGULATION (EU) No 1070/2014
   of 10 October 2014
   amending Regulation (EC) No 271/2009 as regards the minimum content of the preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for laying hens (holder of authorisation BASF SE)
   (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)

               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)

               The use of the preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) was authorised for 10 years for weaned piglets, chickens for fattening, laying hens, turkeys for fattening and ducks for fattening by Commission Regulation (EC) No 271/2009 (2), for chickens reared for laying, turkeys for breeding purposes, turkeys reared for breeding, other minor avian species (other than ducks for fattening) and ornamental birds by Commission Implementing Regulation (EU) No 1068/2011 (3) and for pigs for fattening by Commission Implementing Regulation (EU) No 1404/2013 (4).

               (3)

               In accordance with Article 13(3) of Regulation (EC) No 1831/2003, the holder of the authorisation has proposed changing the terms of the authorisation of that preparation by reducing its minimum content from 560 TXU/kg to 280 TXU/kg and from 250 TGU/kg to 125 TGU/kg of the complete feedingstuff as regards the use on laying hens. The application was accompanied by the relevant supporting data. The Commission forwarded that application to the European Food Safety Authority (hereinafter ‘the Authority’).

               (4)

               The Authority concluded in its opinion of 20 May 2014 (5) that, under the new proposed conditions of use, the preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) has the potential to be efficacious at the requested minimum doses of 280 TXU/kg and 125 TGU/kg of complete feedingstuff on laying hens. 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 endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003 are satisfied.

               (6)

               Regulation (EC) No 271/2009 should therefore be amended accordingly.

               (7)

               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

         HAS ADOPTED THIS REGULATION:
   Article 1
   In the Annex to Regulation (EC) No 271/2009, in the column ‘Minimum content’ corresponding to the entry for laying hens, ‘560 TXU’ is replaced by ‘280 TXU’ and ‘250 TGU’ is replaced by ‘125 TGU’.
   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, 10 October 2014.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  Commission Regulation (EC) No 271/2009 of 2 April 2009 concerning the authorisation of a preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase as a feed additive for weaned piglets, chickens for fattening, laying hens, turkeys for fattening and ducks for fattening (holder of the authorisation BASF SE) (OJ L 91, 3.4.2009, p. 5).

      (3)  Commission Implementing Regulation (EU) No 1068/2011 of 21 October 2011 concerning the authorisation of an enzyme preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for chickens reared for laying, turkeys for breeding purposes, turkeys reared for breeding, other minor avian species (other than ducks for fattening) and ornamental birds (holder of authorisation BASF SE) (OJ L 277, 22.10.2011, p. 11).

      (4)  Commission Implementing Regulation (EU) No 1404/2013 of 20 December 2013 concerning the authorisation of a preparation of endo-1,4-beta-xylanase produced by Aspergillus niger (CBS 109.713) and endo-1,4-beta-glucanase produced by Aspergillus niger (DSM 18404) as a feed additive for pigs for fattening (holder of authorisation BASF SE) (OJ L 349, 21.12.2013, p. 88).

      (5)  EFSA Journal 2014; 12(6):3723.


title: Commission Implementing Regulation (EU) 2017/157 of 30 January 2017 renewing the approval of the active substance thiabendazole in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance. )

text:
                  31.1.2017

                  EN

                  Official Journal of the European Union

                  L 25/5

            COMMISSION IMPLEMENTING REGULATION (EU) 2017/157
      of 30 January 2017
      renewing the approval of the active substance thiabendazole in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
      (Text with EEA relevance)
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) thereof,
      Whereas:

                  (1)

                  The approval of the active substance thiabendazole, as set out in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2), expires on 30 June 2017.

                  (2)

                  An application for the renewal of the inclusion of thiabendazole in Annex I to Council Directive 91/414/EEC (3) was submitted in accordance with Article 4 of Commission Regulation (EU) No 1141/2010 (4) within the time period provided for in that Article.

                  (3)

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

                  (4)

                  The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (hereinafter ‘the Authority’) and the Commission on 28 May 2013.

                  (5)

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

                  (6)

                  On 23 October 2014, the Authority communicated to the Commission its conclusion (5) on whether thiabendazole can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented the draft review report for thiabendazole to the Standing Committee on Plants, Animals, Food and Feed on 20 March 2015.

                  (7)

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

                  (8)

                  It is therefore appropriate to renew the approval of thiabendazole.

                  (9)

                  The risk assessment for the renewal of the approval of thiabendazole is based on a limited number of representative uses, which however do not restrict the uses for which plant protection products containing thiabendazole may be authorised. It is therefore appropriate not to maintain the restriction for uses as a fungicide.

                  (10)

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

                  (11)

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

                  (12)

                  Commission Implementing Regulation (EU) 2016/549 (6) extended the approval period of thiabendazole until 30 June 2017 in order to allow the renewal process to be completed before the expiry of the approval of that substance. However, given that a decision on renewal has been taken ahead of that date, this Regulation should apply from 1 April 2017.

                  (13)

                  The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

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

         This Regulation shall be binding in its entirety and directly applicable in all Member States.
         Done at Brussels, 30 January 2017.

               For the Commission

               The President

            Jean-Claude JUNCKER

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

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

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

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

         (5)  EFSA Journal 2015;12(11):3880. Available online: www.efsa.europa.eu

         (6)  Commission Implementing Regulation (EU) 2016/549 of 8 April 2016 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances bentazone, cyhalofop butyl, diquat, famoxadone, flumioxazine, DPX KE 459 (flupyrsulfuron-methyl), metalaxyl-M, picolinafen, prosulfuron, pymetrozine, thiabendazole and thifensulfuron-methyl (OJ L 95, 9.4.2016, p. 4).

         ANNEX I

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Date of approval

                     Expiration of approval

                     Specific provisions

                     Thiabendazole

                     2-(thiazol-4-yl)benzimidazole

                     ≥ 985 g/kg

                     1 April 2017

                     31 March 2032

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

                                 —

                                 the protection of operators and consumers,

                                 —

                                 the protection of groundwater,

                                 —

                                 the control of waste water from post-harvest uses.

                           Conditions of use shall include risk mitigation measures, where appropriate.
                     The applicant shall submit by 31 March 2019 to the Commission, the Member States and the Authority confirmatory information regarding Level 2 tests as currently indicated in the OECD Conceptual Framework investigating the potential for endocrine-mediated effects of thiabendazole.

                     CAS No 148-79-8
                     CIPAC No 323

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

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

                     (1)

                     in Part A, entry 17 on thiabendazole is deleted;

                     (2)

                     in Part B, the following entry is added:

                                 Common Name, Identification Numbers

                                 IUPAC Name

                                 Purity (*1)

                                 Date of approval

                                 Expiration of approval

                                 Specific provisions

                                 ‘105

                                 Thiabendazole

                                 2-(thiazol-4-yl)benzimidazole

                                 ≥ 985 g/kg

                                 1 April 2017

                                 31 March 2032

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

                                             —

                                             the protection of operators and consumers,

                                             —

                                             the protection of groundwater,

                                             —

                                             the control of waste water from post-harvest uses.

                                       Conditions of use shall include risk mitigation measures, where appropriate.
                                 The applicant shall submit by 31 March 2019 to the Commission, the Member States and the Authority confirmatory information regarding Level 2 tests as currently indicated in the OECD Conceptual Framework investigating the potential for endocrine-mediated effects of thiabendazole.’

                                 CAS No 148-79-8
                                 CIPAC No 323

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


|

Commission Implementing Regulation (EU) No 657/2011 of 7 July 2011 amending Regulation (EU) No 297/2011 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station  Text with EEA relevance

Official Journal L 180 , 08/07/2011 P. 0039 - 0042

		Commission Implementing Regulation (EU) No 657/2011of 7 July 2011amending Regulation (EU) No 297/2011 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station(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 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [1], and in particular Article 53 (1) (b)(ii) thereof,Whereas:(1) Article 53 of Regulation (EC) No 178/2002 provides for the possibility to adopt appropriate Union emergency measures for food and feed imported from a third country in order to protect public health, animal health or the environment, where the risk cannot be contained satisfactorily by means of measures taken by the Member States individually.(2) Following the accident at the Fukushima nuclear power station on 11 March 2011, the Commission was informed that radionuclide levels in certain food products originating in Japan such as milk and spinach exceeded the action levels in food applicable in Japan. Such contamination may constitute a threat to public and animal health in the Union and therefore Commission Implementing Regulation (EU) No 297/2011 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station [2] was adopted.(3) On 14 June 2011, the Commission was informed of the finding of a high level of radioactive caesium in green tea leaves, originating in the Shizuoka prefecture. That was confirmed on 15 June 2011 by five other findings of high level of radioactive caesium in green tea leaves from Shizuoka prefecture. That prefecture is not among the prefectures of the affected zone, where a testing of all feed and food originating from those prefectures is required before export to the Union. Given these recent findings it is appropriate to add Shizuoka prefecture to the affected zone.(4) A significant number of samples taken by the Japanese authorities from food produced in Niigata and Yamagata prefectures show that the production of feed and food in those prefectures is only to a very limited extent affected by the accident at the Fukushima nuclear power station as none of the samples had non-compliant levels of radioactivity, nearly all samples had non-detectable levels of radioactivity and only in few samples low levels of radioactivity were detected. Therefore, it is appropriate to remove those prefectures from the zone, where a testing of all feed and food originating from those prefectures is required before export to the Union.(5) It is therefore appropriate to amend Regulation (EU) No 297/2011 accordingly, whilst keeping the date of applicability of the Regulation unchanged.(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 1Regulation (EU) No 297/2011 is amended as follows:(1) In Article 2, paragraphs 3 and 4 are replaced by the following:"3. Each consignment of the products referred to in Article 1, which leaves Japan from the date of entry into force of this Regulation, shall be accompanied by a declaration, attesting that:(a) the product has been harvested and/or processed before 11 March 2011, or(b) the product originates in and is consigned from a prefecture other than Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Nagano, Yamanashi, Saitama, Tokyo, Chiba, Kanagawa and Shizuoka, or(c) the product is consigned from Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Nagano, Yamanashi, Saitama, Tokyo, Chiba, Kanagawa and Shizuoka prefectures, but does not originate in one of those prefectures and has not been exposed to radioactivity during transiting, or(d) where a product originates in Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Nagano, Yamanashi, Saitama, Tokyo, Chiba, Kanagawa and Shizoka prefectures, the product does not contain levels of radionuclides iodine-131, caesium-134 and caesium-137 above the maximum levels provided for in Annex II to this Regulation. That provision applies also to products caught or harvested in the coastal waters of those prefectures, irrespective of where such products are landed.4. The declaration, referred to in paragraph 3 and as set out in Annex I, shall be signed by an authorised representative of the competent authority of Japan. For the products referred to in point (d) of paragraph 3, the declaration shall be accompanied by an analytical report."(2) Annex I is replaced by the text set out in the Annex to this Regulation.Article 2Entry into forceThis 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, 7 July 2011.For the CommissionThe PresidentJosé Manuel Barroso[1] OJ L 31, 1.2.2002, p. 1.[2] OJ L 80, 26.3.2011, p. 5.--------------------------------------------------ANNEX""ANNEX IDeclaration for the import into the European Union of … (*)Batch identifcation Code …Declaration Number …According to the provisions of the Commission Implementing Regulation (EU) No 297/2011 imposing special conditions governing the import of feed and food originating in or consigned from Japan following the accident at the Fukushima nuclear power station the… (competent authority referred to in Article 2(4))DECLARES that the …… (products referred to in Article 1)of this consignment composed of: …… (description of consignment, product, number and type of packages, gross or net weight)embarked at … (embarkation place)on … (date of embarkation)by … (identification of transporter)going to … (place and country of destination)which comes from the establishment …… (name and address of establishment)has been harvested and/or processed before 11 March 2011.is originating in and consigned from a prefecture other than Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Nagano, Yamanashi, Saitama, Tokyo, Chiba, Kanagawa and Shizuoka.is consigned from the prefectures Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Nagano, Yamanashi, Saitama, Tokyo, Chiba, Kanagawa and Shizuoka, but not originating in one of these prefectures and has not been exposed to radioactivity during transiting, oris originating in the prefectures Fukushima, Gunma, Ibaraki, Tochigi, Miyagi, Nagano, Yamanashi, Saitama, Tokyo, Chiba, Kanagawa and Shizuoka and has been sampled on … (date), subjected to laboratory analysis on … (date) in the … (name of laboratory), to determine the level of the radionuclides, iodine-131, caesium-134 and caesium-137, and the analytical results are in compliance with the maximum levels referred to in Article 2 (3). The analytical report is attached.Done at … on …Stamp and signature of authorised representative of competent authority referred to in Article 2(4)Part to be completed by the competent authority at the BIP or DPEThe consignment has been accepted to be presented to the custom authorities for release for free circulation in the European Union(*) Product and country of origin.+++++ TIFF +++++The consignment has NOT been accepted to be presented to the custom authorities for release for free circulation in the European Union… (Competent authority, Member State)… DateStampSignature"+++++ TIFF +++++"--------------------------------------------------


title: Commission Implementing Regulation (EU) No 1076/2014 of 13 October 2014 concerning the authorisation of a preparation containing a smoke flavouring extract-2b0001 as feed additive for dogs and cats  Text with EEA relevance

text:
               14.10.2014

               EN

               Official Journal of the European Union

               L 296/19

         COMMISSION IMPLEMENTING REGULATION (EU) No 1076/2014
   of 13 October 2014
   concerning the authorisation of a preparation containing a smoke flavouring extract-2b0001 as feed additive for dogs and cats
   (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 an additive consisting of a preparation of a smoke flavouring extract as specified in the Annex to this Regulation. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

               (3)

               That application concerns the authorisation of the preparation specified in the Annex as feed additive for dogs and cats, to be classified in the additive category ‘sensory additives’ and the functional group ‘flavourings compounds’.

               (4)

               The European Food Safety Authority (the Authority) concluded in its opinion of 24 May 2012 (2) that, under the proposed conditions of use in feed, the additive specified in the Annex does not have any adverse effects on animal and human health, or the environment. The Authority concluded that since this smoke flavouring extract is used in food as smoke flavour, and its function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

               (5)

               The Authority concluded that this additive is primarily defined by the manufacturing process and the mix of woods from which it derives, therefore the manufacturing process and the mix of woods need to be clearly specified in the annex to ensure that only smoke flavourings produced by such manufacturing method are placed on the market.

               (6)

               The Authority also concluded that no safety concerns would arise for users provided that appropriate protective measures are taken. 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.

               (7)

               The assessment of the preparation referred to in the Annex shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of preparations containing that smoke flavouring extract should be authorised as specified in the Annex to this Regulation.

               (8)

               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The preparation specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavourings compounds’, 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 that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 13 October 2014.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  EFSA Journal 2012; 10(6):2729.

      ANNEX

                  Identification number of the additive

                  Name of the holder of authorisation

                  Additive

                  Composition, chemical formula, description, analytical method

                  Species or category of animal

                  Maximum age

                  Minimum content

                  Maximum content

                  Other provisions

                  End of period of authorisation

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

                     Category of sensory additives. Functional group: Flavourings compounds.

                  2b0001

                  —

                  Smoke flavouring

                     Additive composition

                  Preparation of smoke flavouring extract
                  Specifications:

                              —

                              Water: 0,3-0,9 wt. %

                              —

                              Acid (expressed as acetic acid): 0,06-0,25 meq/g

                              —

                              pH 1-4

                              —

                              Carbonyl compounds: 1,2-3,0 wt. %

                              —

                              Phenols: 8-12 wt. %.

                     Characterisation of the active substance

                  Liquid smoke flavouring extract containing the following compounds:

                              —

                              Syringol 12,6-25,2 %

                              —

                              4-Methyl syringol 6,2-9,2 %

                              —

                              4-Propenyl syringol 0,8-3,6 %

                              —

                              4-Ethyl syringol 2,7-3,1 %

                              —

                              4-Methyl guaiacol 2,0-2,6 %

                              —

                              4-Allyl syringol 1,8-2,3 %

                              —

                              4-Ethyl guaiacol 1,8-2,40 %

                              —

                              4-Propyl syringol 1-2,5 %

                              —

                              Guaiacol 1,1-1,6 %

                              —

                              2,4-Dimethyl phenol 0,9-1,40 %

                              —

                              Eugenol 1-1,40 %

                              —

                              Isoeugenol (trans) 0,9-1,3 %

                              —

                              4-Propenyl syringol (cis) 0,3-1,7 %

                              —

                              o-Cresol 0,7-1,5 %

                              —

                              Phenol 0,5-1,2 %

                              —

                              p-Cresol 0,7-1,1 %

                              —

                              4-Propyl guaiacol 0,5-1 %

                        Chemical formula:

                              —

                              Syringol: C8H10O3

                              —

                              4-Methyl syringol: C9H12O3

                              —

                              4-Propenyl syringol: C11H14O3

                              —

                              4-Ethyl syringol::C10H14O3

                              —

                              4-Methyl guaiacol: C8H10O2

                              —

                              4-Allyl syringol: C11H14O3

                              —

                              4-Ethyl guaiacol: C9H12O2

                              —

                              4-Propyl syringol: C11H16O3

                              —

                              Guaiacol: C7H8O2

                              —

                              2,4-Dimethyl phenol: C8H10O

                              —

                              Eugenol: C10H12O2

                              —

                              Isoeugenol (trans): C10H12O2

                              —

                              4-Propenyl syringol (cis): C11H14O3

                              —

                              o-Cresol: C7H8O

                              —

                              Phenol: C6H6O

                              —

                              p-Cresol: C7H8O

                              —

                              4-Propyl guaiacol: C10H14O2.

                        CAS number:

                              —

                              Syringol: 91-10-1

                              —

                              4-Methyl syringol: 6638-05-7

                              —

                              4-Propenyl syringol: 20675-95-0

                              —

                              4-Ethyl syringol:14059-92-8

                              —

                              4-Methyl guaiacol: 93-51-6

                              —

                              4-Allyl syringol: 6627-88-9

                              —

                              4-Ethyl guaiacol: 2785-89-9

                              —

                              4-Propyl syringol: 6766-82-1

                              —

                              Guaiacol: 90-05-1

                              —

                              2,4-Dimethyl phenol: 105-67-9

                              —

                              Eugenol: 97-53-0

                              —

                              Isoeugenol (trans): 97-54-1

                              —

                              4-Propenyl syringol (cis): 26624-13-5

                              —

                              o-Cresol: 95-48-7

                              —

                              Phenol: 108-95-2

                              —

                              p-Cresol: 106-44-5

                              —

                              4-Propyl guaiacol: 2785-87-7.

                        Smoke flavouring, liquid form, produced by diethyl ether extraction from tar produced by pyrolysis of a ratio of the following woods: 35 % red oak (Quercus rubra), 35 % white oak (Quercus alba), 10 % maple (Acer saccharum), 10 % beech (Fagus grandifolia) and 10 % hickory (Carya ovata).
                  Purity criteria:

                              —

                              PAH components: Benzo[a]pyrene below 10 ppb and Benz[a]anthracene below 20 ppb

                              —

                              Residual Diethyl Ether below 2 ppm.

                     Method of analysis
                      (1)

                  For the determination of the smoke flavouring extract — in feed additive:
                  titration with sodium hydroxide for determination of total acids; and colour reactions with further spectrophotometry for determination of total carbonyls (at 430 nm) and total phenols (at 610 nm) (FAO JECFA Combined Compendium for Food Additive Specifications ‘smoke flavourings’, Monograph No 1, 2006;
                  Gas chromatography-mass spectrometry (GC-MS); and gas chromatography coupled with flame ionization detection (GC-FID) for characterisation of the volatile fraction of the product (FAO JECFA Combined Compendium for Food Additive Specifications-Monographs No 1, Vol. 4).

                  Dogs and cats

                  —

                  —

                  40

                              1.

                              In the directions for use of the additive and premixture, indicate the storage and stability conditions.

                              2.

                              For user safety: breathing protection and safety glasses should be worn during handling.

                              3.

                              Labelling of premixtures, feed materials and compound feed containing the additive: the name of the additive shall be accompanied by the identification number.

                              4.

                              The preparation may only contain technological additives and/or other substances or products intended to modify the physico-chemical characteristics of the active substance of the preparation and which are used in conformity with their own conditions of authorisation. Physico-chemical and biological compatibility between the components of the preparation shall be ensured in relation to the effects desired.

                              5.

                              The following information shall be set out on the label or accompanying documents of the additive:

                                          —

                                          the name and identification number of any technological additive contained in the preparation;

                                          —

                                          the level of any technological additive contained in the preparation where maximum contents are set in the corresponding authorisation;

                                          —

                                          the name of any substance or product contained in the preparation, indicated in descending order by weight.

                              6.

                              The following information shall be set out on the label or accompanying documents of the premixture containing the additive:
                              the name, identification number and level of any technological additive for which maximum contents are set in the corresponding authorisation.

                  3 November 2024

         (1)  http://irmm.jrc.ec.europa.eu/EURLs/EURL_feed_additives/authorisation/evaluation_reports/Pages/index.aspx


title: Commission Implementing Regulation (EU) No 975/2011 of 30 September 2011 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               1.10.2011

               EN

               Official Journal of the European Union

               L 255/6

         COMMISSION IMPLEMENTING REGULATION (EU) No 975/2011
   of 30 September 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 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:
   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,
   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 hereto.
   Article 2
   This Regulation shall enter into force on 1 October 2011.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 30 September 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 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

                  BR

                  31,9

                  MK

                  28,2

                  ZZ

                  30,1

                  0707 00 05

                  MK

                  44,0

                  TR

                  111,6

                  ZZ

                  77,8

                  0709 90 70

                  TR

                  107,9

                  ZZ

                  107,9

                  0805 50 10

                  AR

                  67,9

                  BR

                  41,3

                  CL

                  65,2

                  TR

                  65,3

                  UY

                  61,2

                  ZA

                  73,7

                  ZZ

                  62,4

                  0806 10 10

                  CL

                  71,6

                  EG

                  65,0

                  MK

                  82,2

                  TR

                  98,7

                  ZA

                  61,1

                  ZZ

                  75,7

                  0808 10 80

                  CL

                  76,1

                  CN

                  82,6

                  NZ

                  103,8

                  US

                  83,1

                  ZA

                  88,5

                  ZZ

                  86,8

                  0808 20 50

                  CN

                  88,7

                  TR

                  120,5

                  ZZ

                  104,6

         (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 1083/2014 of 15 October 2014 concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 (Bonvital) as a feed additive for sows  Text with EEA relevance

text:
               16.10.2014

               EN

               Official Journal of the European Union

               L 298/5

         COMMISSION IMPLEMENTING REGULATION (EU) No 1083/2014
   of 15 October 2014
   concerning the authorisation of a preparation of Enterococcus faecium DSM 7134 (Bonvital) as a feed additive for sows
   (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 the preparation of Enterococcus faecium DSM 7134 (Bonvital). That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

               (3)

               That application concerns the authorisation of the preparation of Enterococcus faecium DSM 7134 (Bonvital) as a feed additive for sows to be used for the duration of the entire reproductive cycle, to be classified in the additive category ‘zootechnical additives’.

               (4)

               The use of the preparation of Enterococcus faecium DSM 7134 was authorised provisionally for piglets and pigs for fattening by Commission Regulation (EC) No 666/2003 (2), provisionally for sows by Commission Regulation (EC) No 2154/2003 (3), provisionally for chickens for fattening by Commission Regulation (EC) No 521/2005 (4), for 10 years for weaned piglets and pigs for fattening by Commission Regulation (EC) No 538/2007 (5) and for 10 years for sows from day 90 of pregnancy to the end of lactation by Commission Regulation (EC) No 1521/2007 (6).

               (5)

               The European Food Safety Authority (the Authority) concluded in its opinion of 18 February 2014 (7) that, under the proposed conditions of use, the preparation of Enterococcus faecium DSM 7134 (Bonvital) does not have an adverse effect on animal health, human health or the environment. It also concluded that the additive has the potential to increase litter weight gain or maintain sow condition. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

               (6)

               The assessment of the preparation of Enterococcus faecium DSM 7134 (Bonvital) 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)

               As a consequence of the authorisation being granted by this Implementing Regulation, Regulation (EC) No 1521/2007 should be repealed.

               (8)

               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

         HAS ADOPTED THIS REGULATION:
   Article 1
   The preparation specified in the Annex, belonging to the category ‘zootechnical additives’ and the functional group ‘gut flora stabilisers’ is authorised as an additive in animal nutrition subject to the conditions laid down in this Annex.
   Article 2
   Regulation (EC) No 1521/2007 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, 15 October 2014.

            For the Commission

            The President

         José Manuel BARROSO

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

      (2)  Commission Regulation (EC) No 666/2003 of 11 April 2003 provisionally authorising the use of certain micro-organisms in feedingstuffs (OJ L 96, 12.4.2003, p. 11).

      (3)  Commission Regulation (EC) No 2154/2003 of 10 December 2003 provisionally authorising certain micro-organisms in feedingstuffs (Enterococcus faecium and Lactobacillus acidophilus) (OJ L 324, 11.12.2003, p. 11).

      (4)  Commission Regulation (EC) No 521/2005 of 1 April 2005 concerning the permanent authorisation of an additive and the provisional authorisation of new uses of certain additives already authorised in feedingstuffs (OJ L 84, 2.4.2005, p. 3).

      (5)  Commission Regulation (EC) No 538/2007 of 15 May 2007 concerning the authorisation of a new use of Enterococcus faecium DSM 7134 (Bonvital) as a feed additive (OJ L 128, 16.5.2007, p. 16).

      (6)  Commission Regulation (EC) No 1521/2007 of 19 December 2007 concerning the authorisation of a new use of Enterococcus faecium DSM 7134 (Bonvital) as a feed additive (OJ L 335, 20.12.2007, p. 24).

      (7)  EFSA Journal 2014; 12(2):3565

      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

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

                     Category of zootechnical additives. Functional group: gut flora stabilisers

                  4b1841

                  Lactosan GmbH & Co KG

                     Enterococcus faecium DSM 7134

                     Additive composition

                  Preparation of Enterococcus faecium DSM 7134 containing a minimum of:

                              Powder: 1 × 1010 CFU/g of additive

                              Granulated (microencapsulated): 1 × 1010 CFU/g of additive

                     Characterisation of the active substance

                  Viable cells of Enterococcus faecium DSM 7134

                     Analytical method
                      (1)

                  Enumeration: spread plate method using bile esculin azide agar (EN 15788)
                  Identification: Pulsed Field Gel Electrophoresis (PFGE).

                  Sows

                  —

                  5 × 108

                  —

                              1.

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

                              2.

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

                  5 November 2024

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


title: Commission Implementing Regulation (EU) 2017/598 of 27 March 2017 establishing the standard import values for determining the entry price of certain fruit and vegetables

text:
               28.3.2017

               EN

               Official Journal of the European Union

               L 81/16

         COMMISSION IMPLEMENTING REGULATION (EU) 2017/598
   of 27 March 2017
   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 Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),
   Having regard to Commission Implementing Regulation (EU) 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, 27 March 2017.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General

            Directorate-General for Agriculture and Rural Development

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

      (2)  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

                  EG

                  145,6

                  IL

                  288,6

                  MA

                  108,8

                  SN

                  213,0

                  TR

                  106,9

                  ZA

                  81,7

                  ZZ

                  157,4

                  0707 00 05

                  TR

                  180,4

                  ZZ

                  180,4

                  0709 93 10

                  MA

                  45,5

                  TR

                  149,9

                  ZZ

                  97,7

                  0805 10 22 , 0805 10 24 , 0805 10 28

                  EG

                  47,8

                  IL

                  83,4

                  MA

                  49,7

                  TN

                  48,4

                  TR

                  72,5

                  ZA

                  99,3

                  ZZ

                  66,9

                  0805 50 10

                  AR

                  45,3

                  EG

                  72,0

                  TR

                  71,4

                  ZZ

                  62,9

                  0808 10 80

                  CL

                  108,0

                  CN

                  142,3

                  US

                  128,4

                  ZA

                  114,1

                  ZZ

                  123,2

                  0808 30 90

                  AR

                  117,1

                  CL

                  135,0

                  CN

                  88,1

                  MA

                  115,2

                  TR

                  148,9

                  ZA

                  116,3

                  ZZ

                  120,1

         (1)  Nomenclature of countries laid down by Commission Regulation (EU) No 1106/2012 of 27 November 2012 implementing Regulation (EC) No 471/2009 of the European Parliament and of the Council on Community statistics relating to external trade with non-member countries, as regards the update of the nomenclature of countries and territories (OJ L 328, 28.11.2012, p. 7). Code ‘ZZ’ stands for ‘of other origin’.


title: Commission Implementing Regulation (EU) 2015/1191 of 20 July 2015 concerning the non-approval of Artemisia vulgaris L. as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (Text with EEA relevance)

text:
               21.7.2015

               EN

               Official Journal of the European Union

               L 193/122

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/1191
   of 20 July 2015
   concerning the non-approval of Artemisia vulgaris L. as a basic substance in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 23(5) in conjunction with Article 13(2) thereof,
   Whereas:

               (1)

               In accordance with Article 23(3) of Regulation (EC) No 1107/2009, the Commission received on 26 April 2013 an application from the Institut Technique de l`Agriculture Biologique (ITAB) for the approval of Artemisia vulgaris L. as basic substance. That application was accompanied by the information required under the second subparagraph of Article 23(3).

               (2)

               The Commission asked the European Food Safety Authority (hereinafter ‘the Authority’) for scientific assistance. The Authority presented to the Commission a Technical Report on the substance concerned on 25 August 2014 (2). The Commission presented the review report (3) and the draft of this Regulation on the non-approval of Artemisia vulgaris L. to the Standing Committee on Plants, Animals, Food and Feed on 27 January 2015.

               (3)

               The documentation provided by the applicant shows that Artemisia vulgaris L. fulfils the criteria of a foodstuff as defined in Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council (4). However, alcoholic beverages from Artemisia species are included in Part B of Annex III to Regulation (EC) No 1334/2008 of the European Parliament and of the Council (5), which sets maximum levels of certain substances, naturally present in flavourings and food ingredients with flavouring properties, in certain compound food as consumed to which flavourings and/or food ingredients with flavouring properties have been added. According to Article 6 of Regulation (EC) No 1334/2008, in the compound foods listed in that Part B, the maximum levels are not to be exceeded as a result of the use of flavourings and/or food ingredients with flavouring properties. The Artemisia species can therefore not be used as a foodstuff without qualification.

               (4)

               Specific concerns were identified in the Technical Report of the Authority regarding exposure to thujone, eucalyptol and camphor and the risk to operators, workers, bystanders, consumers and non-target organisms.

               (5)

               The Commission invited the applicant to submit its comments on the Technical Report of the Authority and on the draft review report. The applicant submitted its comments, which have been carefully examined.

               (6)

               However, despite the arguments put forward by the applicant, the concerns related to the substance cannot be eliminated.

               (7)

               Consequently, it has not been established, in the Commission review report, that the requirements laid down in Article 23 of Regulation (EC) No 1107/2009 are satisfied. It is therefore appropriate not to approve Artemisia vulgaris L. as basic substance.

               (8)

               This Regulation does not prejudice the submission of a further application for the approval of Artemisia vulgaris L. as basic substance in accordance with Article 23(3) of Regulation (EC) No 1107/2009.

               (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
   Non-approval as basic substance
   The substance Artemisia vulgaris L. is not approved as basic substance.
   Article 2
   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, 20 July 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

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

      (2)  Outcome of the consultation with Member States and EFSA on the basic substance application for Artemisia vulgaris for use in plant protection as insecticide/repellent on orchards, vineyards and vegetables. EFSA supporting publication 2014:EN-644. 36pp.

      (3)  http://ec.europa.eu/sanco_pesticides/public/?event=homepage

      (4)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

      (5)  Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC (OJ L 354, 31.12.2008, p. 34).