title: Commission Implementing Regulation (EU) 2021/669 of 23 April 2021 concerning the authorisation of technically pure L-lysine monohydrochloride and liquid L-lysine base produced by Corynebacterium casei KCCM 80190 or Corynebacterium glutamicum KCCM 80216 or Corynebacterium glutamicum KCTC 12307BP as feed additives for all animal species (Text with EEA relevance)

text:
                  26.4.2021

                  EN

                  Official Journal of the European Union

                  L 141/7

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/669
         of 23 April 2021
         concerning the authorisation of technically pure L-lysine monohydrochloride and liquid L-lysine base produced by Corynebacterium casei KCCM 80190 or Corynebacterium glutamicum KCCM 80216 or Corynebacterium glutamicum KCTC 12307BP 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.

                     (2)

                     In accordance with Article 7(1) of Regulation (EC) No 1831/2003, applications were submitted for the authorisation of liquid L-lysine base and technically pure L-lysine monohydrochloride as nutritional feed additives for use in feed and in water for drinking for all animal species. These applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (3)

                     The applications concern the authorisation of L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium casei KCCM 80190 or Corynebacterium glutamicum KCCM 80216 or Corynebacterium glutamicum KCTC 12307BP as feed additives for all animal species to be classified in the additive category ‘nutritional additives’, functional group ‘amino acids, their salts and analogues’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 30 September 2020 (2) and 18 November 2020 (3) (4) that, under the proposed conditions of use, L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium casei KCCM 80190 or Corynebacterium glutamicum KCCM 80216 or Corynebacterium glutamicum KCTC 12307BP do not have an adverse effect on animal health, consumer health or the environment. The Authority could conclude on the safety for the user of the L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium glutamicum KCCM 80216 and Corynebacterium glutamicum KCTC 12307BP. It stated that of L-lysine monohydrochloride, technically pure, and L-lysine base, liquid, produced by Corynebacterium casei KCCM 80190 are considered hazardous by inhalation and that L-lysine monohydrochloride, technically pure, produced by Corynebacterium casei KCCM 80190 is a mild eye irritant. Therefore, appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority concluded that L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium casei KCCM 80190 or Corynebacterium glutamicum KCCM 80216 or Corynebacterium glutamicum KCTC 12307BP, are effective sources of the essential amino acid L-lysine for all animal species. For the supplemental L-lysine to be fully efficacious in ruminants, it should be protected against degradation in the rumen. In its opinions, the Authority referred to a previous statement concerning potential nutritional imbalances for amino acids and hygienic concerns, when they are administered via water for drinking. However, the Authority did not propose a maximum content for the supplementation with L-lysine. Thus, it is appropriate to indicate on the label of the additive, and premixtures containing it, an alert to take into account the dietary supply with all the essential and conditionally essential amino acids, particularly in the case of supplementation with L-lysine as amino acid via water for drinking.

                     (5)

                     The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (6)

                     The assessment of L-lysine base, liquid, and L-lysine monohydrochloride, technically pure, produced by Corynebacterium casei KCCM 80190 or Corynebacterium glutamicum KCCM 80216 or Corynebacterium glutamicum KCTC 12307BP shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation.

                     (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
            The substances specified in the Annex, belonging to the category ‘nutritional additives’ and the functional group ‘amino acids, their salts and analogues’, are authorised as feed additives in animal nutrition, subject to the conditions laid down in that Annex.

            Article 2
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 23 April 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2020;18(11):6285.

            (3)  EFSA Journal 2020;18(12): 6333.

            (4)  EFSA Journal 2020;18(12): 6334.

            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 additive/kg of complete feed with a moisture content of 12 %

                           Category of nutritional additives.

                           Functional group: amino acids, their salts and analogues.

                        3c320

                        -

                        L-lysine base, liquid

                           Additive composition:

                        Aqueous solution of L-lysine with a minimum of 50 % L-lysine.

                        All species

                        -

                        -

                        -

                                    1.

                                    The lysine content shall be indicated on the labelling of the additive.

                                    2.

                                    L-lysine base, liquid, may be placed on the market and used as an additive consisting of a preparation.

                                    3.

                                    The additive can be also used via water for drinking.

                                    4.

                                    Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances.’

                                    5.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks by inhalation, eye or dermal 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 appropriate personal protective equipment, including breathing protection, safety glasses and gloves.

                        16 May 2031

                           Characterisation of the active substance:

                        L-lysine produced by fermentation with Corynebacterium casei KCCM 80190
                        Chemical formula: NH2-(CH2)4-CH(NH2)-COOH
                        CAS Number: 56-87-1

                           Analytical methods
                            (1):
                        For the quantification of lysine in the feed additive and premixtures containing more than 10 % lysine:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) – EN ISO 17180.

                              For the quantification of lysine in premixtures, compound feed and feed materials:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F).

                              For the quantification of lysine in water:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD); or

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS).

                        3c326

                        -

                        L-lysine base, liquid

                           Additive composition:

                        Aqueous solution of L-lysine with a minimum of 50 % L-lysine.

                        All species

                        -

                        -

                        -

                                    1.

                                    The lysine content shall be indicated on the labelling of the additive.

                                    2.

                                    L-lysine base, liquid, may be placed on the market and used as an additive consisting of a preparation.

                                    3.

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

                        16 May 2031

                           Characterisation of the active substance:

                        L-lysine produced by fermentation with Corynebacterium glutamicum KCCM 80216 or Corynebacterium glutamicum KCTC 12307BP
                        Chemical formula: NH2-(CH2)4-CH(NH2)-COOH
                        CAS Number: 56-87-1

                           Analytical methods
                            (1):
                        For the quantification of lysine in the feed additive and premixtures containing more than 10 % lysine:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) – EN ISO 17180.

                              For the quantification of lysine in premixtures, compound feed and feed materials:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F).

                              For the quantification of lysine in water:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD); or

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS).

                        3c322

                        L-lysine monohydrochloride, technically pure

                           Additive composition:

                        Powder of L-lysine monohydrochloride with a minimum of 78 % L-lysine and a maximum moisture content of 1,5 %.

                        All species

                        -

                        -

                        -

                                    1.

                                    The lysine content shall be indicated on the labelling of the additive.

                                    2.

                                    L-lysine monohydrochloride, technically pure, may be placed on the market and used as an additive consisting of a preparation.

                                    3.

                                    The additive can be also used via water for drinking.

                                    4.

                                    Declarations to be made on the labelling of the additive and premixtures: ‘The supplementation with L-lysine, in particular via water for drinking, should take into account all essential and conditionally essential amino acids in order to avoid imbalances.’

                                    5.

                                    The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600  IU endotoxins/m3 air (2).

                                    6.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks by inhalation, eye or dermal 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 appropriate personal protective equipment, including breathing protection, safety glasses and gloves.

                        16 May 2031

                           Characterisation of the active substance:

                        L-lysine monohydrochloride produced by fermentation with

                           Corynebacterium casei KCCM 80190
                        Chemical formula: NH2-(CH2)4-CH(NH2)-COOH
                        CAS Number: 657-27-2

                           Analytical methods  (1):
                        For the identification of L-lysine monohydrochloride in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-lysine monohydrochloride monograph’

                              For the quantification of lysine in the feed additive and premixtures containing more than 10 % lysine:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) – EN ISO 17180.

                              For the quantification of lysine in premixtures, compound feed and feed materials:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F).

                              For the quantification of lysine in water:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD); or

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS).

                        3c327

                        L-lysine monohydrochloride, technically pure

                           Additive composition:

                        Powder of L-lysine monohydrochloride with a minimum of 78 % L-lysine and a maximum moisture content of 1,5 %.

                        All species

                        -

                        -

                        -

                                    1.

                                    The lysine content shall be indicated on the labelling of the additive.

                                    2.

                                    L-lysine monohydrochloride, technically pure, may be placed on the market and used as an additive consisting of a preparation.

                                    3.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address the potential risks by inhalation and eye 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 appropriate personal protective equipment, including breathing protection and safety glasses.

                        16 May 2031

                           Characterisation of the active substance:

                        L-lysine monohydrochloride produced by fermentation with

                           Corynebacterium glutamicum KCCM 80216 or Corynebacterium glutamicum KCTC 12307BP
                        Chemical formula: NH2-(CH2)4-CH(NH2)-COOH
                        CAS Number: 657-27-2

                           Analytical methods
                            (1):
                        For the identification of L-lysine monohydrochloride in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-lysine monohydrochloride monograph’

                              For the quantification of lysine in the feed additive and premixtures containing more than 10 % lysine:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS/FLD) – EN ISO 17180.

                              For the quantification of lysine in premixtures, compound feed and feed materials:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and optical detection (IEC-VIS), Commission Regulation (EC) No 152/2009 (Annex III, F).

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

               (2)  Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2017;15(3):4705); analytical method: European Pharmacopoeia 2.6.14 (bacterial endotoxins).


title: Commission Implementing Regulation (EU) 2021/1367 of 6 August 2021 concerning the classification of certain goods in the Combined Nomenclature

text:
                  17.8.2021

                  EN

                  Official Journal of the European Union

                  L 294/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1367
         of 6 August 2021
         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 three 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 three 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, 6 August 2021.

                  For the Commission,

               Gerassimos THOMAS

                  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)

                        Four-wheeled vehicle with a DC 24V 800W electric motor powered by two 12V rechargeable batteries with 45Ah-capacity. It is approximately 65 cm wide, 125 cm long and 129 cm high (measured at the seat back, 85 cm with the seat back folded down). Its total weight is approximately 107 kg (108 kg including the batteries). The maximum load is approximately 130 kg.
                        The vehicle has the following characteristics:

                                    —

                                    a horizontal platform connecting the front and rear sections; the platform cannot be adjusted in any way (e.g. folded or tilted) to suit the user’s needs,

                                    —

                                    two sprung axles, rear-axle drive and an 820mm wheelbase,

                                    —

                                    gradient capability 130,

                                    —

                                    turning circle 210 cm,

                                    —

                                    two sets of inflatable tyres (the rear tyres being larger than the front ones),

                                    —

                                    a configurable, height-adjustable rotating seat with supports and armrests and a non-slip surface for the feet,

                                    —

                                    an adjustable fold-down steering column with oval-shaped handlebars,

                                    —

                                    front and rear lights, direction indicators and rear-view mirrors.

                              The steering column also has a dashboard featuring a switch box, a speed control, a horn button, an engine-idle button, a blinker switch, a light switch, a battery-status indicator and a speed adjuster.
                        The vehicle has two manually operated levers for accelerating, braking and reversing. The steering can be adjusted to allow operation with one hand.
                        It has a ‘smart’ regenerative electromagnetic braking system.
                        With fully charged batteries, the vehicle has a maximum range of up to 45 kilometres and can reach a maximum speed of approximately 15-16 km/h.
                        It may be fitted with small anti-tipping wheels at the back, a shopping basket, a walking-stick holder, etc.
                        The vehicle may be stowed for transport purposes. It may be used on roads, pavements, footpaths, pathways in parks, cycle paths and certain leisure trails, or in pedestrian areas (e.g. shopping precincts).
                        See image (*1).

                        8703 10 18

                        Classification is determined by General Rules 1 and 6 for the interpretation of the Combined Nomenclature and by the wording of CN codes 8703 , 8703 10  and 8703 10 18 .
                        Classification under heading 8713  as a carriage for disabled persons is excluded as the vehicle is not specially designed for the transport of disabled persons: it has no special features to alleviate a disability.
                        Although the vehicle is designed so that the steering can be controlled with one hand and features a comfortable rotating seat with supports and a non-slip surface for the feet (and may optionally be fitted with small anti-tipping wheels), such characteristics do not objectively constitute special features designed to alleviate a disability (see also the Combined Nomenclature Explanatory Notes (CNEN) to subheading 8713 90 00 , the Harmonized System Explanatory Notes to heading 8713  and HS classification opinion 8703.10/1).
                        In addition, vehicles fitted with a separate, adjustable steering column and those reaching a maximum speed over 10 km per hour are excluded from heading 8713  (see also CNEN to subheading 8713 90 00 ).
                        The vehicle is used for transporting persons and upon presentation to customs authorities it is not recognisable as a vehicle designed solely for disabled persons (see Case C-198/15 (1)), based on its objective characteristics and properties which must be assessed at the time of customs clearance (see Case C-286/15 (2)). Any subsequent post-clearance modification of the vehicle is disregarded as is any assessment of the vehicle that may be carried out by a national authority for purposes other than those laid down in customs legislation.
                        The vehicle is a special type of vehicle for the transport of persons.
                        It is therefore to be classified under CN code 8703 10 18  as a motor vehicle principally designed for the transport of persons, similar to golf cars.

               (*1)  The image is purely for information.

               (1)  Judgment of the Court of 26 May 2016, Invamed Group Ltd and Others v Commissioners for Her Majesty’s Revenue & Customs, C-198/15, ECLI:EU:C:2016:362.

               (2)  Judgment of the Court of 26 May 2016, Latvijas propāna gaze, C-286/15, ECLI:EU:C:2016:363, paragraph 33.


title: Commission Implementing Regulation (EU) 2021/1369 of 6 August 2021 concerning the classification of certain goods in the Combined Nomenclature

text:
                  17.8.2021

                  EN

                  Official Journal of the European Union

                  L 294/8

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1369
         of 6 August 2021
         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 three 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 three 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, 6 August 2021.

                  For the Commission

               Gerassimos THOMAS

                  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)

                        Tape made of elastic textile fabric, of a width of approximately 5 cm, covered on one side with adhesive material made of synthetic rubber, and weighing not more than 1 500  g/m2.
                        The tape comes rolled on a supporting tube and is presented in cardboard boxes containing 16 or 24 rolls, each with a diameter of approximately 7,5 cm. There is no indication on the packaging that the tapes are intended to be used for medical purposes.
                        The tape is presented as tape to be used to protect joints during sport activities.
                        (See images) (*1)

                        5906 10 00

                        Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature, note 4(a) to Chapter 59 and by the wording of CN codes 5906  and 5906 10 00 .
                        The article is neither impregnated nor coated with pharmaceutical substances. It also does not have any objective characteristics that would indicate that it is specially designed for medical, surgical, dental or veterinary purposes. In addition, there is no indication on the packaging that it is intended for medical use. Consequently, classification under heading 3005  is excluded (see also the Harmonized System Explanatory Notes to heading 3005 , third paragraph). It is thus to be classified according to its constituent material.
                        The article is therefore to be classified under CN code 5906 10 00  as adhesive tape of a width not exceeding 20 cm.

               (*1)  The images are purely for information.


title: Commission Implementing Regulation (EU) 2021/2307 of 21 October 2021 laying down rules on documents and notifications required for organic and in-conversion products intended for import into the Union (Text with EEA relevance)

text:
                  27.12.2021

                  EN

                  Official Journal of the European Union

                  L 461/30

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/2307
         of 21 October 2021
         laying down rules on documents and notifications required for organic and in-conversion products intended for import into the Union
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (1), and in particular Article 39(2), points (b) and (c), and Article 43(7) thereof,
         Whereas:

                     (1)

                     In accordance with Article 45(1) of Regulation (EU) 2018/848, a product may be imported from a third country for the purpose of placing that product on the market within the Union as an organic product or as an in-conversion product. Therefore, it is necessary to lay down detailed rules for certain operators in the Union in respect of consignments at the entry into the Union and after the release for free circulation in the Union of a consignment or of a part of a consignment. Those operators are the importers who present the consignment for release for free circulation in the Union, or operators acting on their behalf, and the first consignees and consignees who will receive the consignment or a part of the consignment.

                     (2)

                     With a view to organising a system of official controls on consignments ensuring traceability, the importer should give prior notification of the arrival of a consignment to the competent authority and its own control authority or control body by submitting the relevant information on the certificate of inspection provided for in Commission Delegated Regulation (EU) 2021/2306 (2).

                     (3)

                     In addition, it is necessary to lay down detailed rules with regard to the content of the extract of the certificate of inspection as well as with regard to the technical means by which it is to be issued.

                     (4)

                     The importer, the first consignee and the consignee should provide the certificate of inspection or the extract of the certificate of inspection upon request of the control authorities or control bodies. It is necessary to lay down additional obligations as regards the information to be included by the importer, the first consignee and the consignee, respectively, in the description of the organic or in-conversion production unit referred to in Article 39(1), point (d)(i), of Regulation (EU) 2018/848.

                     (5)

                     To ensure that cases of non-compliance are followed up properly, information on any suspected or established non-compliance found during the verification carried out by the competent authority of a Member State on a consignment should be shared between the Member States and the Commission using the Organic Farming Information System.

                     (6)

                     In relation to the paper certificate of inspection and to the paper extract of certificates of inspection, endorsed on paper with a hand signature in accordance with Delegated Regulation (EU) 2021/2306, it is necessary to lay down transitional requirements for the use of such a certificate and extracts thereof by the first consignee and the consignee, as well as the requirement for such a certificate and extracts thereof to accompany the goods to the premises of the first consignee and of the consignee.

                     (7)

                     In the interest of clarity and legal certainty, this Regulation should apply from the date of application of Regulation (EU) 2018/848.

                     (8)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Subject matter
            This Regulation lays down rules on:

                        (a)

                        the declarations and communications by importers, operators responsible for the consignments, first consignees and consignees for the import of products from third countries for the purpose of placing those products on the market within the Union as organic products or in-conversion products; and

                        (b)

                        the notification by the competent authorities of the Member States of suspected or established non-compliance of consignments.

            Article 2
            Definitions
            For the purposes of this Regulation, the following definitions apply:

                        (1)

                        ‘importer’ means a natural or legal person established in the Union and subject to the control system referred to in Regulation (EU) 2018/848, who presents the consignment for release for free circulation in the Union either on its own, or through a representative;

                        (2)

                        ‘operator responsible for the consignment’ means, for the purposes of Article 6(4) of Delegated Regulation (EU) 2021/2306 and Commission Delegated Regulation (EU) 2019/2123 (3), either the importer or a natural or legal person established in the Union who presents the consignment at the border control post on behalf of the importer;

                        (3)

                        ‘first consignee’ means a natural or legal person established in the Union and subject to the control system referred to in Regulation (EU) 2018/848 to whom the consignment is delivered by the importer after the release for free circulation and who receives it for further preparation and/or marketing;

                        (4)

                        ‘consignee’ means a natural or legal person established in the Union and subject to the control system referred to in Regulation (EU) 2018/848 to whom the batch obtained from the splitting of a consignment is delivered by the importer after the release for free circulation and who receives it for further preparation and/or marketing;

                        (5)

                        ‘consignment’ means a consignment, as defined in Article 3, point (37), of Regulation (EU) 2017/625 of the European Parliament and of the Council (4), of products intended to be placed on the market within the Union as organic products or in-conversion products; however, in case of organic products and in-conversion products exempted from official controls at border control posts in accordance with Commission Delegated Regulation (EU) 2021/2305 (5), it means a quantity of products under one or more Combined Nomenclature codes, covered by a single certificate of inspection, conveyed by the same means of transport and imported from the same third country.

            Article 3
            Prior notification of arrival

               1.   For each consignment, the importer or, where appropriate, the operator responsible for the consignment, shall give prior notification of the arrival of the consignment at the border control post or the point of release for free circulation by completing and submitting in the Trade Control and Expert System (TRACES) referred to in Article 2, point (36), of Commission Implementing Regulation (EU) 2019/1715 (6) the relevant part of the certificate of inspection in accordance with the model and the notes set out in the Annex to Delegated Regulation (EU) 2021/2306 to the following entities:

                           (a)

                           the competent authority referred to in Article 6 of Delegated Regulation (EU) 2021/2306;

                           (b)

                           the control authority or control body of the importer.

               2.   For each consignment subject to official controls at border control posts, paragraph 1 shall apply in addition to the requirements on prior notification to the competent authorities at the border control posts of arrival of consignments pursuant to Article 56(3), point (a), of Regulation (EU) 2017/625.

               3.   Prior notifications pursuant to paragraph 1 shall be given in accordance with the minimum time requirements laid down in Commission Implementing Regulation (EU) 2019/1013 (7).

            Article 4
            Certificate of inspection and extract of the certificate of inspection

               1.   The importer and the first consignee shall complete the certificate of inspection in TRACES as follows:

                           (a)

                           in box 23 on special customs procedures, the importer shall complete in TRACES all the information, except the information on the verification carried out by the relevant competent authority;

                           (b)

                           in box 24 on the first consignee, the importer shall complete in TRACES the information if the information has not been filled in by the control authority or control body in the third country before the verification of the consignment and the endorsement of the certificate of inspection by the competent authority; and

                           (c)

                           box 31 on the declaration of the first consignee shall be completed in TRACES by the first consignee at the reception of the consignment after its release for free circulation.

               2.   If the decision taken on the consignment in accordance with Article 6(3) of Delegated Regulation (EU) 2021/2306 indicates that the consignment is to be released for free circulation, the importer shall report the number of the certificate of inspection in the customs declaration for release for free circulation as referred to in Article 158(1) of Regulation (EU) No 952/2013 of the European Parliament and of the Council (8).

               3.   Where a consignment is split into different batches under customs supervision and before the release for free circulation in accordance with Article 6(6) of Delegated Regulation (EU) 2021/2306, the importer shall complete and submit an extract of the certificate of inspection through TRACES for each of the batches in accordance with the model and the notes set out in the Annex to this Regulation.
               The same applies if a consignment is split into different batches in accordance with Article 7(3) of Delegated Regulation (EU) 2021/2306 after the verification and the endorsement of the certificate of inspection.
               If the decision in relation to a batch recorded in the extract of the certificate of inspection in accordance with Articles 6(6) and 7(4) of Delegated Regulation (EU) 2021/2306 indicates that the batch is to be released for free circulation, the number of the extract of the certificate of inspection shall be reported in the customs declaration for release for free circulation as referred to in Article 158(1) of Regulation EU) No 952/2013.
               The consignee shall, at the reception of a batch, complete in TRACES box 13 of the extract of the certificate of inspection, confirming whether, at the reception of the batch, the packaging or container and, where relevant, the certificate of inspection are in accordance with point 6 of Annex III to Regulation (EU) 2018/848.

               4.   The extract of the certificate of inspection shall be drawn up in the official language or in one of the official languages of the Member State where the batch is to be released for free circulation. A Member State may consent to an extract of the certificates being drawn up in another official language of the Union and accompanied, if necessary, by an authenticated translation.

            Article 5
            Documentary accounts
            Upon request by the relevant competent authority, control authority or control body, the importer, the first consignee or the consignee shall provide the certificate of inspection or, where relevant, the extract of the certificate of inspection in which they are mentioned.

            Article 6
            Description of the production units and activities
            In the case of an importer declaring the consignment for the release for free circulation, the full description of the organic or in-conversion production unit and of the activities as referred to in Article 39(1), point (d)(i), of Regulation (EU) 2018/848 shall include:

                        (a)

                        the premises;

                        (b)

                        the activities, indicating the points of release for free circulation in the Union;

                        (c)

                        any other facilities that the importer intends to use for the storage of the imported products pending their delivery to the first consignee; and

                        (d)

                        an undertaking to ensure that any facilities that will be used for the storage of imported products are submitted to control, to be carried out either by the control authority or control body or, where these storage facilities are situated in another Member State or region, by a control authority or control body recognised for controls in that Member State or region.

                  In the case of the first consignee and the consignee, the description shall include the facilities used for the reception of consignments and their storage.

            Article 7
            Notification of suspected or established non-compliance
            If during the verification of compliance of a consignment in accordance with Article 6 of Delegated Regulation (EU) 2021/2306 cases of suspected or established non-compliance are identified, the Member State concerned shall immediately notify the Commission and the other Member States using the Organic Farming Information System (OFIS) and the template set out in Section 4 of Annex II to Commission Implementing Regulation (EU) 2021/279 (9). The Commission shall inform the competent authority, or where relevant, the control authority or control body of the third country concerned.

            Article 8
            Transitional provisions for paper certificates of inspection and extracts thereof

               1.   The paper certificate of inspection endorsed with a hand signature in accordance with Article 11(2) of Delegated Regulation (EU) 2021/2306 and the paper extract of the certificate of inspection endorsed with a hand signature in accordance with Article 11(5) of that Regulation shall accompany the goods to the premises of the first consignee or of the consignee.

               2.   Upon reception of the paper certificate of inspection referred to in paragraph 1, the first consignee shall verify whether the information reported in that certificate corresponds to the information completed in that certificate in TRACES.
               In case the information relating to the number of packages referred to in box 13 of the certificate of inspection and the information in boxes 16 and 17 of that certificate is not completed in the paper certificate of inspection, or in case that information is different from the information completed in the certificate in TRACES, the first consignee shall consider the information completed in the certificate in TRACES.

               3.   After the verification referred to in paragraph 2, the first consignee shall hand sign the paper certificate of inspection in box 31 and shall send that certificate to the importer mentioned in box 12 thereof.

               4.   The importer shall keep the paper certificate of inspection referred in paragraph 3 at the disposal of the control authority or the control body for at least two years.

               5.   In case of a paper extract of the certificate of inspection as referred to in paragraph 1, the consignee shall, at the reception of the batch, hand sign that paper extract in box 13.

               6.   The consignee of the batch shall keep the paper extract of the certificate of inspection referred to in paragraph 5 at the disposal of the control authorities and/or control bodies for at least two years.

               7.   The first consignee or, where relevant, the importer may make a copy of the paper certificate of inspection referred to in paragraph 3 for the purpose of informing the control authorities and control bodies in accordance with Article 5. Any such copy shall carry the indication ‘COPY’ printed or stamped thereon.

               8.   The consignee or, where relevant, the importer may make a copy of the paper extract of the certificate of inspection referred to in paragraph 5 for the purpose of informing the control authorities and control bodies in accordance with Article 5. Any such copy shall carry the indication ‘COPY’ printed or stamped thereon.

            Article 9
            Entry into force and application
            This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
            It shall apply from 1 January 2022.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 21 October 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 150, 14.6.2018, p. 1.

            (2)  Commission Delegated Regulation (EU) 2021/2306 of 21 October 2021 supplementing Regulation (EU) 2018/848 of the European Parliament and of the Council with rules on the official controls in respect of consignments of organic products and in-conversion products intended for import into the Union and on the certificate of inspection (see page 13 of this Official Journal).

            (3)  Commission Delegated Regulation (EU) 2019/2123 of 10 October 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards rules for the cases where and the conditions under which identity checks and physical checks on certain goods may be performed at control points and documentary checks may be performed at distance from border control posts (OJ L 321, 12.12.2019, p. 64).

            (4)  Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).

            (5)  Commission Delegated Regulation (EU) 2021/2305 of 21 October 2021 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council with rules on the cases where and conditions under which organic products and in-conversion products are exempted from official controls at border control posts, the place of official controls for such products and amending Commission Delegated Regulations (EU) 2019/2123 and (EU) 2019/2124 (see page 5 of this Official Journal).

            (6)  Commission Implementing Regulation (EU) 2019/1715 of 30 September 2019 laying down rules for the functioning of the information management system for official controls and its system components (the IMSOC Regulation) (OJ L 261, 14.10.2019, p. 37).

            (7)  Commission Implementing Regulation (EU) 2019/1013 of 16 April 2019 on prior notification on consignments of certain categories of animals and goods entering the Union (OJ L 165, 21.6.2019, p. 8).

            (8)  Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (OJ L 269, 10.10.2013, p. 1).

            (9)  Commission Implementing Regulation (EU) 2021/279 of 22 February 2021 laying down detailed rules for the implementation of Regulation (EU) 2018/848 of the European Parliament and of the Council on controls and other measures ensuring traceability and compliance in organic production and the labelling of organic products (OJ L 62, 23.2.2021, p. 6).

            ANNEX
            PART I

               EXTRACT No … OF THE CERTIFICATE OF INSPECTION FOR THE IMPORT OF ORGANIC AND IN-CONVERSION PRODUCTS INTO THE EUROPEAN UNION

                                    1.

                                    Control authority or control body having issued the underlying certificate of inspection

                                    2.

                                    Procedures pursuant to Regulation (EU) 2018/848 of the European Parliament and of the Council (1):

                                                ☐

                                                Compliance (Article 46);

                                                ☐

                                                Equivalent third country (Article 48);

                                                ☐

                                                Equivalent control authority or control body (Article 57); or

                                                ☐

                                                Equivalence under a trade agreement (Article 47).

                                    3.

                                    Certificate of inspection reference number

                                    4.

                                    Control authority or control body

                                    5.

                                    Importer

                                    6.

                                    Country of origin

                                    7.

                                    Country of export

                                    8.

                                    Border control post/control point/point of release for free circulation

                                    9.

                                    Country of destination

                                    10.

                                    Consignee of the batch obtained from splitting

                                    11.

                                    Description of products
                                    Organic or in conversion CN codes Category Number of packages Lot number Net weight of the batch and net weight
                                    of the original consignment

                                    12.

                                    Declaration of the relevant competent authority verifying and endorsing the extract of the certificate.
                                    This extract corresponds to the batch described above and obtained by the splitting of a consignment which is covered by an original certificate of inspection with a number mentioned in box 3.

                                                ☐

                                                To be released as organic;

                                                ☐

                                                To be released as in-conversion;

                                                ☐

                                                To be released as non-organic;

                                                ☐

                                                The batch cannot be released for free circulation.

                                          Additional information:
                                    Authority and Member State:
                                    Date:
                                    Name and signature of authorised person/qualified electronic seal

                                    13.

                                    Declaration of the consignee of the batch
                                    This is to confirm that at the reception of the products, the packaging or container and, where relevant, the certificate of inspection are:

                                                ☐

                                                in accordance with point 6 of Annex III to Regulation (EU) 2018/848; or

                                                ☐

                                                not in accordance with point 6 of Annex III to Regulation (EU) 2018/848.

                        Name and signature of the authorised person

                        Date:

                  PART II

               NOTES FOR THE COMPLETION OF THE MODEL OF THE EXTRACT OF THE CERTIFICATE OF INSPECTION

                        Extract No …:

                        The extract number corresponds to the number of the batch obtained from the splitting of the original consignment.

                        Box 1

                        :

                        Name, address and code of the control authority or control body in the third country having issued the underlying certificate of inspection.

                        Box 2

                        :

                        This box indicates the provisions of Regulation (EU) 2018/848 that are relevant for the issue and use of this extract; indicate the relevant provision under which the underlying consignment was imported, see box 2 of the underlying certificate of inspection.

                        Box 3

                        :

                        Number of the certificate of inspection automatically assigned to the underlying certificate by the electronic Trade Control and Expert System (TRACES).

                        Box 4

                        :

                        Name, address and code of the control authority or control body in charge of the controls in respect of the operator having split the consignment.

                        Boxes 5, 6 and 7

                        :

                        See relevant information on the underlying certificate of inspection.

                        Box 8

                        :

                        This is the unique alphanumeric code assigned by TRACES to the border control post or the control point other than a border control post as referred to in Article 53(1), point (a), of Regulation (EU) 2017/625 of the European Parliament and of the Council (2) or the point of release for free circulation into the European Union, as appropriate, including the country where official controls for the verification of the batch are performed in accordance with Article 6(1) and (2) of Commission Delegated Regulation (EU) 2021/2306 (3) and where the decision on the consignment is recorded in box 30 of the certificate of inspection.

                        Box 9

                        :

                        Country of destination means the country of the first consignee in the European Union.

                        Box 10

                        :

                        Consignee of the batch (obtained from the splitting) in the European Union.

                        Box 11

                        :

                        Description of the products, which includes:

                                    —

                                    the indication whether the products are organic or in-conversion;

                                    —

                                    the Combined Nomenclature (CN) code as referred to in Council Regulation (EEC) No 2658/87 (4) for the products concerned (8-digit level where possible);

                                    —

                                    the category of the product in accordance with Annex II to Commission Implementing Regulation (EU) 2021/1378 (5);

                                    —

                                    the number of packages (number of boxes, cartons, bags, buckets, etc.);

                                    —

                                    the net weight expressed in appropriate units (kg of net mass, litre, etc.) and the net weight indicated in box 13 of the underlying certificate of inspection.

                        Box 12

                        :

                        This box must be completed by the competent authority for each of the batches resulting from the splitting operation referred to in Articles 6(6) and 7(3) of Delegated Regulation (EU) 2021/2306.
                        The competent authority must select the appropriate option adding, if necessary, any additional information considered relevant. In particular, if the option ‘The batch cannot be released for free circulation’ has been selected the relevant information must be provided under ‘additional information’.
                        In case of products subject to official controls at border control posts, this box must be completed by the competent authority at the border control post.
                        The hand signature of the authorised person is required only in the case of extracts of certificates of inspection endorsed on paper until 30 June 2022 in accordance with Article 11(5) of Delegated Regulation (EU) 2021/2306.

                        Box 13

                        :

                        This box must be filled in by the consignee at the reception of the batch, selecting one option after carrying out the checks provided for in point 6 of Annex III to Regulation (EU) 2018/848.
                        The hand signature of the consignee is required for extracts of certificates of inspection endorsed on paper until 30 June 2022 in accordance with Article 11(5) of Delegated Regulation (EU) 2021/2306.

               (1)  Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (OJ L 150, 14.6.2018, p. 1).

               (2)  Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1.).

               (3)  Commission Delegated Regulation (EU) 2021/2306 of 21 October 2021 supplementing Regulation (EU) 2018/848 of the European Parliament and of the Council with rules on the official controls in respect of consignments of organic products and in-conversion products intended for import into the Union and on the certificate of inspection (OJ L 461, 27.12.2021, p.13).

               (4)  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).

               (5)  Commission Implementing Regulation (EU) 2021/1378 laying down certain rules concerning the certificate issued to operators, groups of operators and exporters in third countries involved in the imports of organic and in-conversion products into the Union and establishing the list of recognised control authorities and control bodies in accordance with Regulation (EU) 2018/848 of the European Parliament and of the Council (OJ L 297, 20.8.2021, p. 24).