title: Commission Implementing Regulation (EU) 2017/56 of 14 December 2016 concerning the authorisation of lactic acid, 4-oxovaleric acid, succinic acid, fumaric acid, ethyl acetoacetate, ethyl lactate, butyl lactate, ethyl 4-oxovalerate, diethyl succinate, diethyl malonate, butyl-O-butyryllactate, hex-3-enyl lactate, hexyl lactate, butyro-1,4-lactone, decano-1,5-lactone, undecano-1,5-lactone, pentano-1,4-lactone, nonano-1,5-lactone, octano-1,5-lactone, heptano-1,4-lactone and hexano-1,4-lactone as feed additives for all animal species (Text with EEA relevance. )

text:
                  17.1.2017

                  EN

                  Official Journal of the European Union

                  L 13/129

            COMMISSION IMPLEMENTING REGULATION (EU) 2017/56
      of 14 December 2016
      concerning the authorisation of lactic acid, 4-oxovaleric acid, succinic acid, fumaric acid, ethyl acetoacetate, ethyl lactate, butyl lactate, ethyl 4-oxovalerate, diethyl succinate, diethyl malonate, butyl-O-butyryllactate, hex-3-enyl lactate, hexyl lactate, butyro-1,4-lactone, decano-1,5-lactone, undecano-1,5-lactone, pentano-1,4-lactone, nonano-1,5-lactone, octano-1,5-lactone, heptano-1,4-lactone and hexano-1,4-lactone as feed additives for all animal species
      (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)

                  Lactic acid, 4-oxovaleric acid, succinic acid, fumaric acid, ethyl acetoacetate, ethyl lactate, butyl lactate, ethyl 4-oxovalerate, diethyl succinate, diethyl malonate, butyl-O-butyryllactate, hex-3-enyl lactate, hexyl lactate, butyro-1,4-lactone, decano-1,5-lactone, undecano-1,5-lactone, pentano-1,4-lactone, nonano-1,5-lactone, octano-1,5-lactone, heptano-1,4-lactone and hexano-1,4-lactone (‘the substances concerned’) were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those products were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

                  (3)

                  In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of the substances concerned as feed additives for all animal species. The applicant requested those additives to be classified in the additive category ‘sensory 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 opinion of 17 October 2012 (3) that, under the proposed conditions of use in feed the substances concerned do not have adverse effects on animal health, human health or the environment. The Authority further concluded that the function of the substances concerned in feed is similar to that on food. The Authority has already concluded that for food the substances concerned are efficacious, as it increases the food smell or palatability. Therefore, that conclusion can be extrapolated for feed. The Authority is not in a position to evaluate the use of the substances concerned in water for drinking. However, those substances can be used within compound feeds which are subsequently administered via water.

                  (5)

                  Restrictions and conditions should be provided for to allow better control. Since safety reasons do not require the setting of a maximum content and, taking into account the re-evaluation performed by the Authority, recommended contents should be indicated on the label of the additive. Where such contents are exceeded, certain information should be indicated on the label of premixtures, compound feeds and feed materials.

                  (6)

                  The Authority concluded that the substances concerned are considered as potentially hazardous to the respiratory tract skin, eyes and skin sensitisers. Consequently, appropriate protective measures should be 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 additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                  (7)

                  The assessment of the substances concerned shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.

                  (8)

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

                  (9)

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

            HAS ADOPTED THIS REGULATION:
      Article 1
      Authorisation
      The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as feed additives in animal nutrition subject to the conditions laid down in that Annex.
      Article 2
      Transitional measures
      1.   The substances specified in the Annex and premixtures containing those substances, which are produced and labelled before 6 August 2017 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted.
      2.   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 6 February 2018 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.
      3.   Compound feed and feed materials containing the substances as specified in the Annex which are produced and labelled before 6 February 2019 in accordance with the rules applicable before 6 February 2017 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.
      Article 3
      Entry into force
      This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

         This Regulation shall be binding in its entirety and directly applicable in all Member States.
         Done at Brussels, 14 December 2016.

               For the Commission

               The President

            Jean-Claude JUNCKER

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

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

         (3)  EFSA Journal 2012;10(10):2928.

         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 %

                     (1)

                     (2)

                     (3)

                     (4)

                     (5)

                     (6)

                     (7)

                     (8)

                     (9)

                        Category: Sensory additives. Functional group: Flavouring compounds

                     2b08004

                     —

                     Lactic acid

                        Additive composition

                     Lactic acid

                        Characterisation of the active substance

                     Lactic acid
                     Produced by chemical synthesis
                     Purity: min. 95 %
                     Chemical formula: C3H6O3

                     CAS number 598-82-3 and
                     50-21-5 for DL-lactic acid
                     79-33-4 for L-lactic acid
                     FLAVIS No 08.004

                        Method of analysis
                         (1)

                     For the determination of lactic acid in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b08023

                     —

                     4-Oxovaleric acid

                        Additive composition

                     4-Oxovaleric acid

                        Characterisation of the active substance

                     4-Oxovaleric acid
                     Produced by chemical synthesis
                     Purity: min. 97 %
                     Chemical formula: C5H8O3

                     CAS number 123-76-2
                     FLAVIS No 08.023

                        Method of analysis
                         (1)

                     For the determination of 4-oxovaleric acid in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b08024

                     —

                     Succinic acid

                        Additive composition

                     Succinic acid

                        Characterisation of the active substance

                     Succinic acid
                     Produced by chemical synthesis
                     Purity: min. 99 %
                     Chemical formula: C4H6O4

                     CAS number 110-15-6
                     FLAVIS No 08.024

                        Method of analysis
                         (1)

                     For the determination of succinic acid in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b08025

                     —

                     Fumaric acid

                        Additive composition

                     Fumaric acid

                        Characterisation of the active substance

                     Fumaric acid
                     Produced by chemical synthesis
                     Purity: min. 99,5 %
                     Chemical formula: C4H4O4

                     CAS number 110-17-8
                     FLAVIS No 08.025

                        Method of analysis
                         (1)

                     For the determination of fumaric acid in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b09402

                     —

                     Ethyl acetoacetate

                        Additive composition

                     Ethyl acetoacetate

                        Characterisation of the active substance

                     Ethyl acetoacetate
                     Produced by chemical synthesis
                     Purity: min. 97,5 %
                     Chemical formula: C6H10O3

                     CAS number 141-97-9
                     FLAVIS No 09.402

                        Method of analysis
                         (1)

                     For the determination of ethyl acetoacetate in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b09433

                     —

                     Ethyl lactate

                        Additive composition

                     Ethyl lactate

                        Characterisation of the active substance

                     Ethyl lactate
                     Produced by chemical synthesis
                     Purity: min. 97 %
                     Chemical formula: C5H10O3

                     CAS number 97-64-3
                     FLAVIS No 09.433

                        Method of analysis
                         (1)

                     For the determination of ethyl lactate in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 125 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 125 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 125 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b09434

                     —

                     Butyl lactate

                        Additive composition

                     Butyl lactate

                        Characterisation of the active substance

                     Butyl lactate
                     Produced by chemical synthesis
                     Purity: min. 95 %
                     Chemical formula: C7H14O3

                     CAS number 138-22-7
                     FLAVIS No 09.434

                        Method of analysis
                         (1)

                     For the determination of butyl lactate in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b09435

                     —

                     Ethyl 4-oxovalerate

                        Additive composition

                     Ethyl 4-oxovalerate

                        Characterisation of the active substance

                     Ethyl 4-oxovalerate
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C7H12O3

                     CAS number 539-88-8
                     FLAVIS No 09.435

                        Method of analysis
                         (1)

                     For the determination of ethyl 4-oxovalerate in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b09444

                     —

                     Diethyl succinate

                        Additive composition

                     Diethyl succinate

                        Characterisation of the active substance

                     Diethyl succinate
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C8H14O4

                     CAS number 123-25-1
                     FLAVIS No 09.444

                        Method of analysis
                         (1)

                     For the determination of diethyl succinate in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b09490

                     —

                     Diethyl malonate

                        Additive composition

                     Diethyl malonate

                        Characterisation of the active substance

                     Diethyl malonate
                     Produced by chemical synthesis
                     Purity: min. 97 %
                     Chemical formula: C7H12O4

                     CAS number 105-53-3
                     FLAVIS No 09.490

                        Method of analysis
                         (1)

                     For the determination of diethyl malonate in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b09491

                     —

                     Butyl-O-butyryllactate

                        Additive composition

                     Butyl-O-butyryllactate

                        Characterisation of the active substance

                     Butyl-O-butyryllactate
                     Produced by chemical synthesis
                     Purity: min. 95 %
                     Chemical formula: C11H20O4

                     CAS number 7492-70-8
                     FLAVIS No 09.491

                        Method of analysis
                         (1)

                     For the determination of butyl-O-butyryllactate in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b09545

                     —

                     Hex-3-enyl lactate

                        Additive composition

                     Hex-3-enyl lactate

                        Characterisation of the active substance

                     Hex-3-enyl lactate
                     Produced by chemical synthesis
                     Purity: min. 96 %
                     Chemical formula: C9H16O3

                     CAS number 61931-81-5
                     FLAVIS No 09.545

                        Method of analysis
                         (1)

                     For the determination of hex-3-enyl lactate in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b09580

                     —

                     Hexyl lactate

                        Additive composition

                     Hexyl lactate

                        Characterisation of the active substance

                     Hexyl lactate
                     Produced by chemical synthesis
                     Purity: min. 95 %
                     Chemical formula: C9H18O3

                     CAS number 20279-51-0
                     FLAVIS No 09.580

                        Method of analysis
                         (1)

                     For the determination of hexyl lactate in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b10006

                     —

                     Butyro-1,4-lactone

                        Additive composition

                     Butyro-1,4-lactone

                        Characterisation of the active substance

                     Butyro-1,4-lactone
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C4H6O2

                     CAS number 96-48-0
                     FLAVIS No 10.006

                        Method of analysis
                         (1)

                     For the determination of butyro-1,4-lactone in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b10007

                     —

                     Decano-1,5-lactone

                        Additive composition

                     Decano-1,5-lactone

                        Characterisation of the active substance

                     Decano-1,5-lactone
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C10H18O2

                     CAS number 705-86-2
                     FLAVIS No 10.007

                        Method of analysis
                         (1)

                     For the determination of decano-1,5-lactone in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b10011

                     —

                     Undecano-1,5-lactone

                        Additive composition

                     Undecano-1,5-lactone

                        Characterisation of the active substance

                     Undecano-1,5-lactone
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C11H20O2

                     CAS number 710-04-3
                     FLAVIS No 10.011

                        Method of analysis
                         (1)

                     For the determination of undecano-1,5-lactone in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b10013

                     —

                     Pentano-1,4-lactone

                        Additive composition

                     Pentano-1,4-lactone

                        Characterisation of the active substance

                     Pentano-1,4-lactone
                     Produced by chemical synthesis
                     Purity: min. 95 %
                     Chemical formula: C5H8O2

                     CAS number 108-29-2
                     FLAVIS No 10.013

                        Method of analysis
                         (1)

                     For the determination of pentano-1,4-lactone in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b10014

                     —

                     Nonano-1,5-lactone

                        Additive composition

                     Nonano-1,5-lactone

                        Characterisation of the active substance

                     Nonano-1,5-lactone
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C9H16O2

                     CAS number 3301-94-8
                     FLAVIS No 10.014

                        Method of analysis
                         (1)

                     For the determination of nonano-1,5-lactone in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b10015

                     —

                     Octano-1,5-lactone

                        Additive composition

                     Octano-1,5-lactone

                        Characterisation of the active substance

                     Octano-1,5-lactone
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C8H14O2

                     CAS number 698-76-0
                     FLAVIS No 10.015

                        Method of analysis
                         (1)

                     For the determination of octano-1,5-lactone in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b10020

                     —

                     Heptano-1,4-lactone

                        Additive composition

                     Heptano-1,4-lactone

                        Characterisation of the active substance

                     Heptano-1,4-lactone
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C7H12O2

                     CAS number 105-21-5
                     FLAVIS No 10.020

                        Method of analysis
                         (1)

                     For the determination of heptano-1,4-lactone in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

                     2b10021

                     —

                     Hexano-1,4-lactone

                        Additive composition

                     Hexano-1,4-lactone

                        Characterisation of the active substance

                     Hexano-1,4-lactone
                     Produced by chemical synthesis
                     Purity: min. 98 %
                     Chemical formula: C6H10O2

                     CAS number 695-06-7
                     FLAVIS No 10.021

                        Method of analysis
                         (1)

                     For the determination of hexano-1,4-lactone in the feed additive and in feed flavouring premixtures.
                     Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

                     All animal species

                     —

                     —

                     —

                                 1.

                                 The additive shall be incorporated into the feed in the form of a premixture.

                                 2.

                                 In the directions for use of the additive and premixtures, the storage and stability conditions shall be indicated.

                                 3.

                                 The recommended maximum content of the active substance shall be: 5 mg/kg of complete feedingstuff with a moisture content of 12 %.

                                 4.

                                 On the label of the additive the following shall be indicated:
                                 ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 5 mg/kg’.

                                 5.

                                 The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the labelling of the premixtures, feed materials and compound feedingstuffs, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 5 mg/kg.

                                 6.

                                 For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including safety glasses and gloves.

                     6 February 2027

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


title: Commission Implementing Regulation (EU) 2016/2035 of 21 November 2016 amending Implementing Regulation (EU) No 540/2011 as regards the approval periods of the active substances fipronil and maneb (Text with EEA relevance )

text:
               22.11.2016

               EN

               Official Journal of the European Union

               L 314/7

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/2035
   of 21 November 2016
   amending Implementing Regulation (EU) No 540/2011 as regards the approval periods of the active substances fipronil and maneb
   (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 the first paragraph of Article 17 thereof,
   Whereas:

               (1)

               Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

               (2)

               The approval period of the active substance maneb was extended from 30 June 2016 until 31 January 2018 by Commission Implementing Regulation (EU) No 762/2013 (3).

               (3)

               The approval period of the active substance fipronil was extended from 30 September 2017 until 31 July 2018 by Commission Implementing Regulation (EU) 2015/404 (4).

               (4)

               Applications for the renewal of the approval of the substances maneb and fipronil were submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5). However no supplementary dossiers were submitted in support of the renewal of those active substances in accordance with Article 6 of Implementing Regulation (EU) No 844/2012.

               (5)

               In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, the extensions provided for by Implementing Regulations (EU) No 762/2013 and (EU) No 2015/404 are no longer justified. It is therefore appropriate to provide that the approval of fipronil expires at the date it would expire without the extension, and to provide for the earliest possible expiry date for the approval period of maneb taking into account the time necessary for Member States to meet the requirements resulting from the expiry of the approval of the substance maneb.

               (6)

               Implementing Regulation (EU) No 540/2011 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
   Part A of the Annex to Implementing Regulation (EU) No 540/2011 in accordance with the Annex to this Regulation.
   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, 21 November 2016.

            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)  Commission Implementing Regulation (EU) No 762/2013 of 7 August 2013 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances chlorpyrifos, chlorpyrifos-methyl, mancozeb, maneb, MCPA, MCPB and metiram (OJ L 213, 8.8.2013, p. 14).

      (4)  Commission Implementing Regulation (EU) 2015/404 of 11 March 2015 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances beflubutamid, captan, dimethoate, dimethomorph, ethoprophos, fipronil, folpet, formetanate, glufosinate, methiocarb, metribuzin, phosmet, pirimiphos-methyl and propamocarb (OJ L 67, 12.3.2015, p. 6).

      (5)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

      ANNEX
      Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

                  (1)

                  In the sixth column, expiration of approval, of row 113, maneb, the date ‘31 January 2018’ is replaced by ‘31 January 2017’;

                  (2)

                  In the sixth column, expiration of approval, of row 157, fipronil, the date of ‘31 July 2018’ is replaced by ‘30 September 2017’.


title: Council Implementing Regulation (EU) No 332/2012 of 13 April 2012 amending Regulation (EC) No 130/2006 imposing a definitive anti-dumping duty and collecting definitively the provisional duty imposed on imports of tartaric acid originating in the People’s Republic of China, and excluding company Hangzhou Bioking Biochemical Engineering Co., Ltd from the definitive measures

text:
               20.4.2012

               EN

               Official Journal of the European Union

               L 108/1

         COUNCIL IMPLEMENTING REGULATION (EU) No 332/2012
   of 13 April 2012
   amending Regulation (EC) No 130/2006 imposing a definitive anti-dumping duty and collecting definitively the provisional duty imposed on imports of tartaric acid originating in the People’s Republic of China, and excluding company Hangzhou Bioking Biochemical Engineering Co., Ltd from the definitive measures
   THE COUNCIL OF THE EUROPEAN UNION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 1515/2001 of 23 July 2001 on the measures that may be taken by the Community following a report adopted by the WTO Dispute Settlement Body concerning anti-dumping and anti-subsidy matters (1), and in particular Article 2(1) thereof,
   Having regard to the proposal submitted by the European Commission (‘the Commission’) after having consulted the Advisory Committee,
   Whereas:
   A.   PROCEDURE

   1.   Measures in force

               (1)

               By Regulation (EC) No 130/2006 (2), the Council imposed a definitive anti-dumping duty, ranging from 0 % to 34,9 %, on imports of tartaric acid (‘TA’) originating in the People’s Republic of China (‘China’). The rate of the definitive anti-dumping duty imposed on TA produced by the Chinese exporting producer Hangzhou Bioking Biochemical Engineering Co., Ltd (‘Hangzhou Bioking’) was 0 %.

         2.   Initiation of an expiry review and of a review of existing measures on Hangzhou Bioking

               (2)

               Following the publication of a notice of impending expiry (3) of the anti-dumping measures in force, the Commission received on 27 October 2009 a request for the initiation of an expiry review of these measures pursuant to Article 11(2) of Council Regulation (EC) No 1225/2009 of 30 November 2009 on protection against dumped imports from countries not members of the European Community (4) (‘the basic Regulation’).

               (3)

               Having determined, after consulting the Advisory Committee, that sufficient evidence existed for the initiation of an expiry review, the Commission announced on 26 January 2011 the initiation of an expiry review pursuant to Article 11(2) of the basic Regulation, by a notice published in the Official Journal of the European Union
                   (5) (‘Notice of initiation’).

               (4)

               In the Notice of initiation, the Commission also announced the initiation of a review of existing measures on Hangzhou Bioking pursuant to Article 2(3) of Regulation (EC) No 1515/2001 in order to allow for any necessary amendment of Regulation (EC) No 130/2006 in the light of the WTO Appellate Body report entitled Mexico — Definitive Anti-Dumping Measures on Beef and Rice (6). This report found, in paragraphs 305 and 306, that an exporting producer not found to be dumping in an original investigation has to be excluded from the scope of the definitive measure imposed as a result of such investigation and cannot be made subject to administrative and changed circumstances review.

         3.   Initiation of a new proceeding

               (5)

               On 29 July 2011, the Commission announced, by a notice published in the Official Journal of the European Union
                   (7), the initiation of an anti-dumping investigation pursuant to Article 5 of the basic Regulation concerning imports into the European Union of tartaric acid originating in China, limited to Hangzhou Bioking.

         4.   Exclusion of Hangzhou Bioking from the definitive anti-dumping measures imposed by Regulation (EC) No 130/2006

               (6)

               Hangzhou Bioking should be excluded from the definitive anti-dumping measures imposed by Regulation (EC) No 130/2006 in order not to fall under two anti-dumping proceedings at the same time,

         HAS ADOPTED THIS REGULATION:
   Article 1
   Regulation (EC) No 130/2006 is hereby amended as follows:
   In Article 1(2), in the table, the entry concerning Hangzhou Bioking Biochemical Engineering Co., Ltd shall be deleted and the entry ‘All other companies’ shall be replaced by the entry ‘All other companies (except Hangzhou Bioking Biochemical Engineering Co., Ltd — TARIC additional code A687)’.
   Article 2
   This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 13 April 2012.

            For the Council

            The President

         N. WAMMEN

      (1)  OJ L 201, 26.7.2001, p. 10.

      (2)  OJ L 23, 27.1.2006, p. 1.

      (3)  OJ C 211, 4.8.2010, p. 11.

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

      (5)  OJ C 24, 26.1.2011, p. 14.

      (6)  WT/DS295/AB/R, 29 November 2005.

      (7)  OJ C 223, 29.7.2011, p. 11.


title: Commission Implementing Regulation (EU) 2016/2224 of 5 December 2016 concerning the classification of certain goods in the Combined Nomenclature

text:
               10.12.2016

               EN

               Official Journal of the European Union

               L 336/22

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/2224
   of 5 December 2016
   concerning the classification of certain goods in the Combined Nomenclature
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Article 57(4) and Article 58(2) thereof,
   Whereas:

               (1)

               In order to ensure uniform application of the Combined Nomenclature annexed to Council Regulation (EEC) No 2658/87 (2), it is necessary to adopt measures concerning the classification of the goods referred to in the Annex to this Regulation.

               (2)

               Regulation (EEC) No 2658/87 has laid down the general rules for the interpretation of the Combined Nomenclature. Those rules apply also to any other nomenclature which is wholly or partly based on it or which adds any additional subdivision to it and which is established by specific provisions of the Union, with a view to the application of tariff and other measures relating to trade in goods.

               (3)

               Pursuant to those general rules, the goods described in column (1) of the table set out in the Annex should be classified under the CN code indicated in column (2), by virtue of the reasons set out in column (3) of that table.

               (4)

               It is appropriate to provide that binding tariff information issued in respect of the goods concerned by this Regulation which does not conform to this Regulation may, for a certain period, continue to be invoked by the holder in accordance with Article 34(9) of Regulation (EU) No 952/2013. That period should be set at 3 months.

               (5)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN code indicated in column (2) of that table.
   Article 2
   Binding tariff information which does not conform to this Regulation may continue to be invoked in accordance with Article 34(9) of Regulation (EU) No 952/2013 for a period of 3 months from the date of entry into force of this Regulation.
   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, 5 December 2016.

            For the Commission

         Stephen QUEST

            Director-General

            Directorate-General for Taxation and Customs Union

      (1)  OJ L 269, 10.10.2013, p. 1.

      (2)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (OJ L 256, 7.9.1987, p. 1).

      ANNEX

                  Description of the goods

                  Classification
                  (CN-code)

                  Reasons

                  (1)

                  (2)

                  (3)

                  An electrical apparatus (so-called ‘wireless speaker adapter’) in a housing with dimensions of approximately 52 × 52 ×13 mm and a weight of 26 g.
                  The wireless speaker adapter consists of:

                              —

                              a built-in rechargeable battery,

                              —

                              a digital/analogue converter,

                              —

                              a Bluetooth technology based transmitter and receiver (Advanced Audio Distribution Profile (A2DP),

                              —

                              a USB port for charging, and

                              —

                              a 3,5 mm audio port, for connection to a speaker system (not present upon presentation to customs).

                        The apparatus allows the user to listen to music from a smartphone or similar portable device on a home audio system or via separate loudspeakers.
                  The audio signal is sent wirelessly via Bluetooth from the smartphone to the apparatus. In the apparatus, the digital signal is converted to an analogue signal and sent by cables to the home audio system or to separate loudspeakers. The apparatus has a pause/play button that allows stopping and starting the music, but does not allow for selection of music or volume control.

                  8517 62 00

                  Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature and by the wording of CN codes 8517  and 8517 62 00 .
                  As the apparatus can only send and receive audio signals wirelessly via Bluetooth (A2DP), and does not itself generate the audio signal or produce the sound it cannot be considered a sound reproducing apparatus. Classification under heading 8519  is therefore excluded.
                  The function of the apparatus is to receive audio data wirelessly from a device (for example a mobile phone) and to transmit those data using cables to loudspeakers. The function of receiving, converting and transmitting data is covered by the wording of CN code 8517 62 00 .
                  The apparatus is therefore to be classified under CN code 8517 62 00  as a machine for the reception, conversion and transmission of voice or other data.


title: Commission Implementing Regulation (EU) 2015/1740 of 29 September 2015 amending for the 237th time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al Qaida network

text:
               30.9.2015

               EN

               Official Journal of the European Union

               L 253/7

         COMMISSION IMPLEMENTING REGULATION (EU) 2015/1740
   of 29 September 2015
   amending for the 237th time Council Regulation (EC) No 881/2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al Qaida network
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Regulation (EC) No 881/2002 of 27 May 2002 imposing certain specific restrictive measures directed against certain persons and entities associated with the Al-Qaida network (1), and in particular Articles 7(1)(a), 7a(1) and 7a(5) thereof,
   Whereas:

               (1)

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

               (2)

               On 9 September 2015 the Sanctions Committee of the United Nations Security Council (UNSC) approved the deletion of one person to the Al-Qaida Sanctions Committee's list of persons, groups and entities to whom the freezing of funds and economic resources should apply. Moreover, on 21 September the UNSC added four entries to the list.

               (3)

               Annex I to Regulation (EC) No 881/2002 should therefore be updated accordingly.

               (4)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   Annex I to Regulation (EC) No 881/2002 is amended in accordance with the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 29 September 2015.

            For the Commission,

            On behalf of the President,

            Head of the Service for Foreign Policy Instrument

      (1)  OJ L 139, 29.5.2002, p. 9.

      ANNEX
      Annex I to Regulation (EC) No 881/2002 is amended as follows:

                  (1)

                  The following entries shall be added to Annex I to Regulation (EC) No 881/2002 under the heading ‘Natural persons’:

                              (a)

                                 ‘Abd Al-Aziz Aday Zimin Al-Fadhil (alias (a) Abd al-Aziz Udai Samin al-Fadhli; (b) Abd al-Aziz Udai Samin al-Fadhl; (c) Abd al-Aziz Adhay Zimin al-Fadhli; (d) Abdalaziz Ad'ai Samin Fadhli al-Fadhali). Date of birth 27.8.1981. Place of birth Kuwait. National identification: 281082701081. Date of designation referred to in Article 2a(4)(b): 21.9.2015.’

                              (b)

                                 ‘Abd Al-Latif Bin Abdallah Salih Muhammad Al-Kawari (alias (a) Abd-al-Latif Abdallah Salih al-Kawari, (b) Abd-al-Latif Abdallah Salih al-Kuwari, (c) Abd-al-Latif Abdallah al-Kawwari, (d) Abd-al-Latif Abdallah al-Kawari, (e) Abu Ali al-Kawari). Date of birth 28.9.1973. Nationality: Qatari. Passport no: (a) Qatari passport number 01020802, (b) Qatari passport number 00754833 issued on 20.5.2007, (c) Qatari passport number 00490327 issued on 28.7.2001. National identification no: Qatari identity card number 27363400684. Address: Al-Laqtah, Qatar. Date of designation referred to in Article 2a(4)(b): 21.9.2015.’

                              (c)

                                 ‘Hamad Awad Dahi Sarhan Al-Shammari (alias (a) Abu Uqlah al-Kuwaiti) Date of birth: 31.1.1984. Nationality: Kuwaiti. Passport no: Kuwaiti passport number 155454275. National identification no: Kuwaiti identity card number 284013101406. Date of designation referred to in Article 2a(4)(b): 21.9.2015.’

                              (d)

                                 ‘Sa'd Bin Sa'd Muhammad Shariyan Al-Ka'bi (alias (a) Sa'd bin Sa'd Muhammad Shiryan al-Ka'bi; (b) Sa'd Sa'd Muhammad Shiryan al-Ka'bi; (c) Sa'd al-Sharyan al-Ka'bi; (d) Abu Haza'; (e) Abu Hazza'; (f) Umar al-Afghani; (g) Abu Sa'd; (h) Abu Suad. Date of birth: 15.2.1972. Nationality: Qatari. Passport no: Qatari passport number 00966737. Date of designation referred to in Article 2a(4)(b): 21.9.2015.’

                  (2)

                  The following entry under the heading ‘Natural persons’ is deleted:
                  ‘Yasser Mohamed Ismail Abu Shaweesh (alias Yasser Mohamed Abou Shaweesh). Address: Germany (in prison). Date of birth: 20.11.1973. Place of birth: Benghazi, Libyan Arab Jamahiriya. Nationality: Stateless Palestinian. Passport No: (a) 939254 (Egyptian travel document), (b) 0003213 (Egyptian passport), (c) 981358 (Egyptian passport), (d) C00071659 (passport substitute issued by the Federal Republic of Germany). Other information: Sentenced to 5 years and 6 months imprisonment in Germany on 6 Dec. 2007. Date of designation referred to in Article 2a(4)(b): 6.12.2005.’


title: Commission Implementing Regulation (EU) 2016/30 of 13 January 2016 laying down the allocation coefficient to be applied to the quantities covered by the applications for import licences lodged from 4 January 2016 to 8 January 2016 under the tariff quotas opened by Implementing Regulation (EU) 2015/2081 for certain cereals originating in Ukraine

text:
               14.1.2016

               EN

               Official Journal of the European Union

               L 9/12

         COMMISSION IMPLEMENTING REGULATION (EU) 2016/30
   of 13 January 2016
   laying down the allocation coefficient to be applied to the quantities covered by the applications for import licences lodged from 4 January 2016 to 8 January 2016 under the tariff quotas opened by Implementing Regulation (EU) 2015/2081 for certain cereals originating in Ukraine
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 188(1) and (3) thereof,
   Whereas:

               (1)

               Commission Implementing Regulation (EU) 2015/2081 (2) opened import tariff quotas for certain cereals originating in Ukraine.

               (2)

               Article 1(1) of Implementing Regulation (EU) 2015/2081 set, for the period from 1 January 2016 to 31 December 2016 the quantity of the quota with order number 09.4308 at 400 000 tonnes.

               (3)

               The quantities covered by the applications for import licences lodged from 4 January 2016 to 8 January 2016 at 13.00 (Brussels time) exceed those available for the quota with order number 09.4308. The extent to which import licences may be issued should therefore be determined by fixing the allocation coefficient to be applied to the quantities requested under the quota concerned, calculated in accordance with Article 7(2) of Commission Regulation (EC) No 1301/2006 (3).

               (4)

               No further import licences should be issued for the tariff quota with order number 09.4308 referred to in Implementing Regulation (EU) 2015/2081 for the current quota period.

               (5)

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

         HAS ADOPTED THIS REGULATION:
   Article 1
   1.   The quantities covered by the applications for import licences under the quota with order number 09.4308 and referred to in the Annex to Implementing Regulation (EU) 2015/2081, lodged from 4 January 2016 to 8 January 2016 at 13.00 (Brussels time), shall be multiplied by an allocation coefficient of 46,782204 % for applications lodged under the tariff quota with order number 09.4308.
   2.   The submission of new import licence applications under the quota with order number 09.4308 referred to in the Annex to Implementing Regulation (EU) 2015/2081 shall be suspended from 8 January 2016 at 13.00 (Brussels time) for the current quota period.
   Article 2
   This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 13 January 2016.

            For the Commission,

            On behalf of the President,

         Jerzy PLEWA

            Director-General for Agriculture and Rural Development

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

      (2)  Commission Implementing Regulation (EU) 2015/2081 of 18 November 2015 opening and providing for the administration of import tariff quotas for certain cereals originating in Ukraine (OJ L 302, 19.11.2015, p. 81).

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


title: Commission Implementing Regulation (EU) No 1330/2013 of 12 December 2013 amending Regulation (EC) No 1484/95 as regards representative prices in the poultrymeat and egg sectors and for egg albumin

text:
               13.12.2013

               EN

               Official Journal of the European Union

               L 334/12

         COMMISSION IMPLEMENTING REGULATION (EU) No 1330/2013
   of 12 December 2013
   amending Regulation (EC) No 1484/95 as regards representative prices in the poultrymeat and egg sectors and for egg albumin
   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 143 in conjunction with Article 4 thereof,
   Having regard to Council Regulation (EC) No 614/2009 of 7 July 2009 on the common system of trade for ovalbumin and lactalbumin (2), and in particular Article 3(4) thereof,
   Whereas:

               (1)

               Commission Regulation (EC) No 1484/95 (3) lays down detailed rules for implementing the system of additional import duties and fixes representative prices in the poultrymeat and egg sectors and for egg albumin.

               (2)

               Regular monitoring of the data used to determine representative prices for poultrymeat and egg products and for egg albumin shows that the representative import prices for certain products should be amended to take account of variations in price according to origin.

               (3)

               Regulation (EC) No 1484/95 should be amended accordingly.

               (4)

               Given the need to ensure that this measure applies as soon as possible after the updated data have been made available, this Regulation should enter into force on the day of its publication.

               (5)

               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 I to Regulation (EC) No 1484/95 is replaced by the text set out in the Annex to this Regulation.
   Article 2
   This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

      This Regulation shall be binding in its entirety and directly applicable in all Member States.
      Done at Brussels, 12 December 2013.

            For the Commission, On behalf of the President,
         Jerzy PLEWA

            Director-General for Agriculture and Rural Development

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

      (2)  OJ L 181, 14.7.2009, p. 8.

      (3)  OJ L 145, 29.6.1995, p. 47.

      ANNEX

            ‘ANNEX I

                        CN code

                        Description of goods

                        Representative price
                        (EUR/100 kg)

                        Security pursuant to Article 3(3)
                        (EUR/100 kg)

                        Origin (1)

                        0207 12 10

                        Fowls of the species Gallus domesticus, not cut in pieces, presented as “70 % chickens”, frozen

                        121,1

                        0

                        AR

                        0207 12 90

                        Fowls of the species Gallus domesticus, not cut in pieces, presented as “65 % chickens”, frozen

                        134,7

                        0

                        AR

                        131,2

                        0

                        BR

                        0207 14 10

                        Fowls of the species Gallus domesticus, boneless cuts, frozen

                        289,6

                        3

                        AR

                        218,4

                        25

                        BR

                        321,9

                        0

                        CL

                        254,3

                        14

                        TH

                        0207 27 10

                        Turkeys, boneless cuts, frozen

                        314,3

                        0

                        BR

                        333,7

                        0

                        CL

                        0408 91 80

                        Eggs, not in shell, dried

                        468,7

                        0

                        AR

                        1602 32 11

                        Preparations of fowls of the species Gallus domesticus, uncooked

                        265,3

                        6

                        BR

                        315,1

                        0

                        CL

         (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”.’