title: Commission Implementing Regulation (EU) 2019/1948 of 25 November 2019 initiating an investigation concerning possible circumvention of anti-dumping measures imposed by Commission Implementing Regulation (EU) 2018/186 on imports of certain corrosion resistant steels originating in the People’s Republic of China, and making such imports subject to registration

text:
                  26.11.2019

                  EN

                  Official Journal of the European Union

                  L 304/10

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1948
         of 25 November 2019
         initiating an investigation concerning possible circumvention of anti-dumping measures imposed by Commission Implementing Regulation (EU) 2018/186 on imports of certain corrosion resistant steels originating in the People’s Republic of China, and making such imports subject to registration
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council on protection against dumped imports from countries not members of the European Union (1) and in particular Articles 13(3) and 14(5) thereof,
         After having informed the Member States,
         Whereas:
         A.   EX OFFICIO INVESTIGATION

                     (1)

                     The European Commission (‘the Commission’) has decided on its own initiative, pursuant to Articles 13(3) and 14(5) of Regulation (EU) 2016/1036 (‘the basic Regulation’), to investigate the possible circumvention of the anti-dumping measures imposed on imports of certain corrosion resistant steels originating in the People’s Republic of China and to make such imports subject to registration.

               B.   PRODUCT

                     (2)

                     The product concerned by the possible circumvention is flat-rolled products of iron or alloy steel or non-alloy steel; aluminium killed; plated or coated by hot dip galvanisation with zinc and/or with aluminium, and no other metal; chemically passivated; containing by weight: 0,015 % or more but not more than 0,170 % of carbon, 0,015 % or more but not more than 0,100 % of aluminium, not more than 0,045 % of niobium, not more than 0,010 % of titanium and not more than 0,010 % of vanadium; presented in coils, cut-to-length sheets and narrow strips.
                     The following products are excluded:

                                 —

                                 of stainless steel, of silicon-electrical steel, and of high-speed steel,

                                 —

                                 not further worked than hot-rolled or cold-rolled (cold-reduced).

                           The product concerned is currently falling under CN codes ex 7210 41 00, ex 7210 49 00, ex 7210 61 00, ex 7210 69 00, ex 7212 30 00, ex 7212 50 61, ex 7212 50 69, ex 7225 92 00, ex 7225 99 00, ex 7226 99 30 and ex 7226 99 70 (TARIC codes: 7210410020, 7210490020, 7210610020, 7210690020, 7212300020, 7212506120, 7212506920, 7225920020, 7225990022, 7225990092, 7226993010, 7226997094) and originating in in the People’s Republic of China (‘the product concerned’). This is the product to which the measures that are currently in force apply.
                     The product under investigation for possible circumvention is certain corrosion resistant steels. These are flat-rolled products of iron or alloy steel or non-alloy steel; plated or coated by hot dip galvanisation with zinc and/or aluminium and/or magnesium, whether or not alloyed with silicon; chemically passivated; with or without any additional surface treatment such as oiling or sealing; containing by weight: not more than 0,5 % of carbon, not more than 1,1 % of aluminium, not more than 0,12 % of niobium, not more than 0,17 % of titanium and not more than 0,15 % of vanadium; presented in coils, cut-to-length sheets and narrow strips, currently falling under CN codes ex 7210 41 00, ex 7210 49 00, ex 7210 61 00, ex 7210 69 00, ex 7210 90 80, ex 7212 30 00, ex 7212 50 61, ex 7212 50 69, ex 7212 50 90, ex 7225 92 00, ex 7225 99 00, ex 7226 99 30, ex 7226 99 70 (TARIC codes: 7210410030, 7210490030, 7210610030, 7210690030, 7210908092, 7212300030, 7212506130, 7212506930, 7212509014, 7212509092, 7225920030, 7225990023, 7225990041, 7225990093, 7226993030, 7226997013, 7226997093), originating in the People’s Republic of China (‘the product under investigation’).
                     The following products are excluded:

                                 —

                                 of stainless steel, of silicon-electrical steel, and of high-speed steel,

                                 —

                                 not further worked than hot-rolled or cold-rolled (cold-reduced),

                                 —

                                 the product concerned as defined in recital 2 above.

               C.   EXISTING MEASURES

                     (3)

                     The measures currently in force and possibly being circumvented are anti-dumping measures imposed by Commission Implementing Regulation (EU) 2018/186 (2) (‘the existing measures’).

               D.   GROUNDS

                     (4)

                     The Commission has at its disposal sufficient evidence that the existing anti-dumping measures on imports of the product concerned originating in the People’s Republic of China are being circumvented by slight modifications of the product concerned.

                     (5)

                     More specifically, TARIC statistics show that a significant change in the pattern of trade involving exports from the People’s Republic of China to the Union has taken place following the imposition of the definitive anti-dumping duty on the product concerned imposed by Commission Implementing Regulation (EU) 2018/186. This change appears without sufficient due cause or economic justification for such a change other than the imposition of the duty.

                     (6)

                     In addition, the evidence points to the fact that this change stems from the importation of the slightly modified product concerned, for example by applying a thin oil-coating, by slightly increasing the content of carbon, aluminium, niobium, titanium, or vanadium, or by changing the coating from simple zinc or aluminium coatings e.g. to zinc-magnesium-aluminium coating. The prima facie evidence demonstrates that there is no due cause or economic justification other than the imposition of the duty for such practice, process or work.

                     (7)

                     Furthermore, the Commission obtained sufficient prima facie evidence that the remedial effects of the existing anti-dumping measures on the product concerned are being undermined both in terms of quantity and price. Significant volumes of imports of the product under investigation appear to have replaced imports of the product concerned. In addition, there is sufficient prima facie evidence that imports of the product under investigation are made at prices below the non-injurious price established in the investigation that led to the existing measures.

                     (8)

                     Finally, the Commission obtained sufficient prima facie evidence that the prices of the product under investigation are dumped in relation to the normal value previously established.

                     (9)

                     Should circumvention practices covered by Article 13 of the basic Regulation, other than the one mentioned above, be identified in the course of the investigation, the investigation may also cover these practices.

               E.   PROCEDURE

                     (10)

                     In light of the above, the Commission has concluded that sufficient evidence exists to justify the initiation of an investigation pursuant to Article 13(3) of the basic Regulation and to make imports of the products under investigation subject to registration, in accordance with Article 14(5) of the basic Regulation.

               (a)   Questionnaires

                     (11)

                     In order to obtain information it deems necessary for its investigation, the Commission will send questionnaires to the known exporters/producers and to the known associations of exporters/producers in the People’s Republic of China. Information, as appropriate, may also be sought from the Union industry.

                     (12)

                     In any event, all interested parties should contact the Commission forthwith, but not later than the time-limit set in Article 3(2) of this Regulation. The time-limit set in Article 3(2) of this Regulation applies to all interested parties.

                     (13)

                     The authorities of the People’s Republic of China will be notified of the initiation of the investigation.

               (b)   Collection of information and holding of hearings

                     (14)

                     All interested parties including the Union industry, importers and any relevant association are invited to make their views known in writing and to provide supporting evidence provided that such submissions are made within the deadline provided for in Article 3(2). Furthermore, the Commission may hear interested parties, provided that they make a request in writing and show that there are particular reasons why they should be heard.

               (c)   Exemption from registration of imports or measures

                     (15)

                     In accordance with Article 13(4) of the basic Regulation, imports of the product under investigation may be exempted from registration or measures if the importation does not constitute circumvention.

               F.   REGISTRATION

                     (16)

                     Pursuant to Article 14(5) of the basic Regulation, imports of the product under investigation shall be made subject to registration in order to ensure that, should the investigation result in findings of circumvention, anti-dumping duties of an appropriate amount can be levied from the date on which registration of such imports was imposed.

               G.   TIME-LIMITS

                     (17)

                     In the interest of sound administration, time-limits should be stated within which:

                                 —

                                 interested parties may make themselves known to the Commission, present their views in writing and submit questionnaire replies or any other information to be taken into account during the investigation,

                                 —

                                 interested parties may make a written request to be heard by the Commission.

                     (18)

                     Attention is drawn to the fact that the exercise of procedural rights set out in the basic Regulation depends on the party’s making itself known within the time-limits laid down in Article 3 of this Regulation.

               H.   NON-COOPERATION

                     (19)

                     If any interested party refuses access to or does not provide the necessary information within the time-limits, or significantly impedes the investigation, findings, affirmative or negative, may be made on the basis of facts available in accordance with Article 18 of the basic Regulation.

                     (20)

                     Where it is found that any interested party has supplied false or misleading information, the information shall be disregarded and use may be made of facts available in accordance with Article 18 of the basic Regulation.

                     (21)

                     If an interested party does not cooperate or cooperates only partially and findings are therefore based on the facts available in accordance with Article 18 of the basic Regulation, the result may be less favourable to that party than if it had cooperated.

               I.   SCHEDULE OF THE INVESTIGATION

                     (22)

                     The investigation will be concluded, pursuant to Article 13(3) of the basic Regulation, within nine months of the date of entry into force of this Regulation.

               J.   PROCESSING OF PERSONAL DATA

                     (23)

                     It is noted that any personal data collected in this investigation will be treated in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data (3).

                     (24)

                     A data protection notice that informs all individuals of the processing of personal data in the framework of Commission’s trade defence activities is available on DG Trade’s website: http://ec.europa.eu/trade/policy/accessing-markets/trade-defence/

               K.   HEARING OFFICER

                     (25)

                     Interested parties may request the intervention of the Hearing Officer in trade proceedings. The Hearing Officer reviews requests for access to the file, disputes regarding the confidentiality of documents, requests for extension of time limits and any other request concerning the rights of defence of interested parties and third parties as may arise during the proceeding.

                     (26)

                     The Hearing Officer may organise hearings and mediate between the interested party/-ies and Commissions services to ensure that the interested parties’ rights of defence are being fully exercised.

                     (27)

                     A request for a hearing with the Hearing Officer should be made in writing and should specify the reasons for the request. The Hearing Officer will examine the reasons for the requests. These hearings should only take place if the issues have not been settled with the Commission services in the due course.

                     (28)

                     Any request must be submitted in good time and expeditiously so as not to jeopardise the orderly conduct of proceedings. To that effect, interested parties should request the intervention of the Hearing Officer at the earliest possible time following the occurrence of the event justifying such intervention. In principle, the timeframes set out in Article 3 to request hearings with the Commission services apply mutatis mutandis to requests for hearings with the Hearing Officer. Where hearing requests are submitted outside the relevant timeframes, the Hearing Officer will also examine the reasons for such late requests, the nature of the issues raised and the impact of those issues on the rights of defence, having due regard to the interests of good administration and the timely completion of the investigation.

                     (29)

                     For further information and contact details interested parties may consult the Hearing Officer’s web pages on the Directorate-General for Trade’s website: http://ec.europa.eu/trade/trade-policy-and-you/contacts/hearing-officer/,

               HAS ADOPTED THIS REGULATION:

            Article 1
            An investigation is initiated pursuant to Article 13(3) of Regulation (EU) 2016/1036, in order to determine if imports into the Union of flat-rolled products of iron or alloy steel or non-alloy steel; plated or coated by hot dip galvanisation with zinc and/or aluminium and/or magnesium, whether or not alloyed with silicon; chemically passivated; with or without any additional surface treatment such as oiling or sealing; containing by weight: not more than 0,5 % of carbon, not more than 1,1 % of aluminium, not more than 0,12 % of niobium, not more than 0,17 % of titanium and not more than 0,15 % of vanadium; presented in coils, cut-to-length sheets and narrow strips, currently falling under CN codes ex 7210 41 00, ex 7210 49 00, ex 7210 61 00, ex 7210 69 00, ex 7210 90 80, ex 7212 30 00, ex 7212 50 61, ex 7212 50 69, ex 7212 50 90, ex 7225 92 00, ex 7225 99 00, ex 7226 99 30, ex 7226 99 70 (TARIC codes: 7210410030, 7210490030, 7210610030, 7210690030, 7210908092, 7212300030, 7212506130, 7212506930, 7212509014, 7212509092, 7225920030, 7225990023, 7225990041, 7225990093, 7226993030, 7226997013, 7226997093)(‘certain corrosion resistant steels’), originating in the People’s Republic of China, are circumventing the measures imposed by Commission Implementing Regulation (EU) 2018/186.
            The following products are excluded:

                        —

                        of stainless steel, of silicon-electrical steel, and of high-speed steel,

                        —

                        not further worked than hot-rolled or cold-rolled (cold-reduced),

                        —

                        the product concerned as defined in recital 2 above.

            Article 2
            The Customs authorities shall, pursuant to Article 13(3) and Article 14(5) of Regulation (EU) 2016/1036, take the appropriate steps to register the imports into the Union identified in Article 1 of this Regulation.
            Registration shall expire nine months following the date of entry into force of this Regulation.
            The Commission, by regulation, may direct Customs authorities to cease registration in respect of imports into the Union of products made by exporters/producers having applied for an exemption from registration and having been found to fulfil the conditions for an exemption to be granted.

            Article 3

               1.   A copy of the questionnaires is available on DG Trade website http://trade.ec.europa.eu/tdi/case_details.cfm?id=2409

               2.   Interested parties, if their representations are to be taken into account during the investigation, must make themselves known by contacting the Commission, present their views in writing and submit questionnaire replies or any other information within 37 days from the date of entry into force of this Regulation, unless otherwise specified.

               3.   Interested parties may also apply to be heard by the Commission within the same 37-day time limit.

               4.   Information submitted to the Commission for the purpose of trade defence investigations shall be free from copyrights. Interested parties, before submitting to the Commission information and/or data which is subject to third party copyrights, must request specific permission to the copyright holder explicitly allowing (a) the Commission to use the information and data for the purpose of this trade defence proceeding; and (b) to provide the information and/or data to interested parties to this investigation in a form that allows them to exercise their right of defence.

               5.   All written submissions, including the information requested in this Regulation, completed questionnaires and correspondence provided by interested parties for which confidential treatment is requested shall be labelled ‘Limited’ (4).

               6.   Interested parties providing ‘Limited’ information are required to furnish non-confidential summaries of it pursuant to Article 19(2) of Regulation (EU) 2016/1036, which will be labelled ‘For inspection by interested parties’. These summaries should be sufficiently detailed to permit a reasonable understanding of the substance of the information submitted in confidence. If an interested party providing confidential information does not furnish a non-confidential summary of it in the requested format and quality, such information may be disregarded.

               7.   Interested parties are invited to make all submissions and requests via TRON.tdi (https://tron.trade.ec.europa.eu/tron/TDI), including scanned powers of attorney and certification sheets, with the exception of large replies, which shall be submitted on a CD-R or DVD by hand or by registered mail.
               In order to have access to TRON.tdi, interested parties need an EU Login account. Full instructions on how to register and use TRON.tdi are available on https://webgate.ec.europa.eu/tron/resources/documents/gettingStarted.pdf
               By using TRON.tdi or email, interested parties express their agreement with the rules applicable to electronic submissions contained in the document ‘CORRESPONDENCE WITH THE EUROPEAN COMMISSION IN TRADE DEFENCE CASES’ published on the website of the Directorate-General for Trade: http://trade.ec.europa.eu/doclib/docs/2011/june/tradoc_148003.pdf
               The interested parties must indicate their name, address, telephone and a valid email address and they should ensure that the provided email address is a functioning official business email which is checked on a daily basis. Once contact details are provided, the Commission will communicate with interested parties by email only, unless they explicitly request to receive all documents from the Commission by another means of communication or unless the nature of the document to be sent requires the use of a registered mail. For further rules and information concerning correspondence with the Commission including principles that apply to submissions by email, interested parties should consult the communication instructions with interested parties referred to above.
               Commission address for correspondence:

                           European Commission

                           Directorate-General for Trade

                           Directorate H

                           Office: CHAR 04/039

                           1049 Brussels

                           BELGIUM

                           TRON.tdi: https://tron.trade.ec.europa.eu/tron/TDI

                     Emails: TRADE-R705-CORROSION-RESISTANT-STEELS@ec.europa.eu

            Article 4
            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, 25 November 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 176, 30.6.2016, p. 21.

            (2)  Commission Implementing Regulation (EU) 2018/186 of 7 February 2018 imposing a definitive anti-dumping duty and collecting definitively the provisional duty imposed on imports of certain corrosion resistant steels originating in the People’s Republic of China (OJ L 34, 8.2.2018, p. 16).

            (3)  Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).

            (4)  A ‘Limited’ document is a document which is considered confidential pursuant to Article 19 of the basic Regulation and Article 6 of the WTO Agreement on Implementation of Article VI of the GATT 1994 (Anti-Dumping Agreement). It is also a document protected pursuant to Article 4 of Regulation (EC) No 1049/2001 of the European Parliament and of the Council (OJ L 145, 31.5.2001, p. 43).


title: Commission Implementing Regulation (EU) 2020/107 of 23 January 2020 concerning the authorisation of ponceau 4R as a feed additive for dogs, cats and ornamental fish (Text with EEA relevance)

text:
                  24.1.2020

                  EN

                  Official Journal of the European Union

                  L 19/18

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/107
         of 23 January 2020
         concerning the authorisation of ponceau 4R as a feed additive for dogs, cats and ornamental fish
         (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(2) of Regulation (EC) No 1831/2003 provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

                     (2)

                     Ponceau 4R was authorised without a time limit in accordance with Directive 70/524/EEC as a feed additive for ornamental fish belonging to the group ‘colourants, including pigments’, under the heading ‘other colourants’. It was also authorised without a time limit as a feed additive for dogs and cats belonging to the group ‘colourants, including pigments’, under the heading ‘colouring agents authorised for colouring foodstuffs by Community rules’. The additive was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1)(b) 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 ponceau 4R as a feed additive for ornamental fish and for dogs and cats. The applicant requested the additive to be classified in the additive category ‘sensory additive’ and in the functional group ‘colourants’. The 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 6 March 2018 (3) that, under the proposed conditions of use, ponceau 4R does not have an adverse effect on animal health. It also concluded that the inhalation exposure to additive is regarded as hazardous for the user of the additive and that no conclusion could be drawn on the irritancy potential to skin or eyes and on the skin sensitation. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. In accordance with Commission Regulation (EC) No 429/2008 (4), phase I of the environmental risk assessment has determined that ponceau 4R, as an additive intended for non-food producing animals, is exempted from further assessment due to the unlikelihood of a significant environmental effect, there being no scientifically-based evidence for concern having been identified by the Authority in its above-mentioned opinion. The Authority also stated that for this additive, which is also authorised in food, where the function is the same as that for feed, no further demonstration of efficacy might be necessary. However, the Authority, considering the wide variety of feedingstuffs, requested further demonstration. The applicant demonstrated the efficacy in a typical feed matrix for 50 mg/kg but also indicated that for other matrixes (colour in petfood may range from almost white to dark brown) lower levels may be used specially in pale matrixes (the applicant provided in the dossier some evidence for lower levels). As the recommended maximum level proposed by the Authority for this additive is similar to the levels authorised for food in different types of products, the Commission considered that there is sufficient evidence of the efficacy of this substance. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (5)

                     The assessment of ponceau 4R shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that additive should be authorised as specified in the Annex to this Regulation.

                     (6)

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

                     (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
            Authorisation
            The substance specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘colourants’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

            Article 2
            Transitional measures

               1.   The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 13 August 2020 in accordance with the rules applicable before 13 February 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

               2.   Feed materials and compound feed containing the substance specified in the Annex which are produced and labelled before 13 February 2022 in accordance with the rules applicable before 13 February 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

            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, 23 January 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (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 2018; 16(3):5222.

            (4)  Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1).

            ANNEX

                        Identification number of the additive

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

                           Category: Sensory additives. Functional group: Colourants. (i) substances that add or restore colour in feedingstuffs

                        2a124

                        Ponceau 4R

                           Additive composition

                        Ponceau 4R described as the sodium salt as the principal component.
                        Solid form (powder or granules)

                        Cats

                        —

                        —

                        31

                                    1.

                                    In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

                                    2.

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

                        13 February 2030

                           Characterisation of the active substance as the sodium salt

                        Ponceau 4R consists essentially of trisodium 2-hydroxy-1-(4-sulfonato1-naphthylazo) naphthalene-6,8-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.
                        The calcium and the potassium salts are also permitted
                        Chemical formula: C20H11N2O10S3Na3

                        Solid form (powder or granules) produced by chemical synthesis
                        CAS No: 2611-82-7
                        Purity criteria

                                    —

                                    Total colouring matters calculated as the sodium salt ≥ 80 % (assay);

                                    —

                                    Subsidiary colouring matter ≤ 1 %;

                                    —

                                    Organic compounds other than colouring matters ≤ 0,5 %;

                                    —

                                    Unsulfonated primary aromatic amines (calculated as aniline) ≤ 0,01 %.

                           Analytical method
                            (1)

                        For the quantification of total colouring matters content of ponceau 4R in the feed additive:
                        Spectrophotometry at 505 nm and titration with Titanous chloride as described in Commission Regulation (EU) No 231/2012 referring to FAO JECFA Combined Compendium for Food Additive Specifications (Analytical methods Vol. 4); and the Monograph No 11 (2011) ‘Ponceau 4R’.
                        For the quantification of ponceau 4R in feedingstuffs:
                        High performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS)

                        Dogs

                        —

                        —

                        37

                           Category: Sensory additives. Functional group: Colourants. (iii) substances which favourably affect the colour of ornamental fish or birds

                        2a124

                        Ponceau 4R

                           Additive composition

                        Ponceau 4R described as the sodium salt as the principal component.
                        Solid form (powder or granules)

                        Ornamental fish

                        —

                        —

                        137

                                    1.

                                    In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

                                    2.

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

                        13 February 2030

                           Characterisation of the active substance as the sodium salt

                        Ponceau 4R consists essentially of trisodium 2-hydroxy-1-(4-sulfonato1-naphthylazo) naphthalene-6,8-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components
                        The calcium and the potassium salts are also permitted
                        Chemical formula: C20H11N2O10S3Na3

                        Solid form (powder or granules) produced by chemical synthesis
                        CAS No: 2611-82-7
                        Purity criteria

                                    —

                                    Total colouring matters calculated as the sodium salt ≥ 80 % (assay);

                                    —

                                    Subsidiary colouring matter ≤ 1 %;

                                    —

                                    Organic compounds other than colouring matters ≤ 0,5 %;

                                    —

                                    Unsulfonated primary aromatic amines (calculated as aniline) ≤ 0,01 %.

                           Analytical method
                            (1)

                        For the quantification of total colouring matters content of ponceau 4R in the feed additive:
                        Spectrophotometry at 505 nm and titration with Titanous chloride as described in Commission Regulation (EU) No 231/2012 referring to FAO JECFA Combined Compendium for Food Additive Specifications (Analytical methods Vol. 4); and the Monograph No 11 (2011) ‘Ponceau 4R’.
                        For the quantification of ponceau 4R in feedingstuffs:
                        High performance liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS)

               (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) 2020/104 of 23 January 2020 making imports of certain hot rolled stainless steel sheets and coils originating in the People’s Republic of China, Taiwan and Indonesia subject to registration

text:
                  24.1.2020

                  EN

                  Official Journal of the European Union

                  L 19/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/104
         of 23 January 2020
         making imports of certain hot rolled stainless steel sheets and coils originating in the People’s Republic of China, Taiwan and Indonesia subject to registration
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2016/1036 of the European Parliament and of the Council of 8 June 2016 on protection against dumped imports from countries not members of the European Union (1) (‘the basic Regulation’), and in particular Article 14(5) thereof,
         After informing the Member States,
         Whereas:

                     (1)

                     On 12 August 2019, the European Commission (‘the Commission’) announced, by a notice published in the Official Journal of the European Union (2) (‘the notice of initiation’), the initiation of an anti-dumping proceeding (‘the proceeding’) with regard to imports into the Union of certain hot rolled stainless steel sheets and coils originating in the People’s Republic of China (‘the PRC’), Taiwan and Indonesia following a complaint lodged on 28 June 2019 by Eurofer, the European Steel Association (‘the complainant’) on behalf of four Union producers representing the entirety of Union production of certain hot rolled stainless steel sheets and coils.

                     (2)

                     On 10 October 2019, the Commission announced the initiation of an anti-subsidy proceeding with regard to imports into the Union of the same product originating in the PRC and Indonesia (3) (‘the parallel anti-subsidy proceeding’), pursuant to Article 10 of Regulation (EU) 2016/1037 of the European Parliament and of the Council of 8 June 2016 on protection against subsidised imports from countries not members of the European Union (4) (‘the basic anti-subsidy Regulation’).

               1.   PRODUCT CONCERNED AND LIKE PRODUCT

                     (3)

                     The product subject to registration (‘the product concerned’) is flat-rolled products of stainless steel, whether or not in coils (including products cut-to-length and narrow strip), not further worked than hot-rolled and excluding products, not in coils, of a width of 600 mm or more and of a thickness exceeding 10 mm. These products are currently falling under HS codes 7219 11, 7219 12, 7219 13, 7219 14, 7219 22, 7219 23, 7219 24, 7220 11 and 7220 12. These HS codes are given for information only.

               2.   REQUEST

                     (4)

                     The complainant already requested in its complaint the registration of imports. On 31 October 2019, the complainant submitted a separate registration request, with regard to the imports which are subject to this proceeding pursuant to Article 14(5) of the basic Regulation. The complainant requested that imports of the product concerned be made subject to registration so that measures may subsequently be applied against those imports from the date of such registration. Further communication in support of this request was submitted on 22 November and 10 December 2019.

                     (5)

                     On 14 November 2019, Marcegaglia Specialties (‘Marcegaglia’), a user of the product concerned, which is cooperating with the anti-dumping proceeding, submitted comments in relation to the complainant’s request for registration of imports.

               3.   GROUNDS FOR REGISTRATION

                     (6)

                     According to Article 14(5) of the basic Regulation, the Commission may direct the customs authorities to take the appropriate steps to register imports, so that measures may subsequently be applied against those imports from the date of such registration. Imports may be made subject to registration following a request from the Union industry, which contains sufficient evidence to justify such action.

                     (7)

                     According to the complainant registration is justified as the product concerned originating in the PRC, Taiwan and Indonesia is being dumped. It argued that significant injury to the Union industry is being caused by an acceleration of low-priced imports which will undermine the remedial effect of potential definitive duties by allowing stockpiling.

                     (8)

                     The Commission examined the request in the light of Article 10(4) of the basic Regulation. The Commission verified whether importers were aware, or should have been aware, of the dumping as regards the extent of the dumping and the injury alleged or found. It also analysed whether there was a further substantial rise in imports which, in the light of its timing and volume and other circumstances, is likely to seriously undermine the remedial effect of the definitive anti-dumping duty to be applied.

               3.1.   Awareness of the importers of the dumping, the extent thereof and the alleged injury

                     (9)

                     The Notice of Initiation for this proceeding published on 12 August 2019 highlighted that the dumping margins calculated are significant for all countries. As a whole, and given the extent of the alleged dumping margins ranging from 15,1 % to 54,3 %, the evidence in the complaint provides sufficient support at this stage that the exporting producers practice dumping.

                     (10)

                     The complaint also provided sufficient evidence of alleged injury to the Union industry, including a decline in market share and a negative development of other key performance indicators of the Union industry.

                     (11)

                     By its publication in the Official Journal of the European Union, the Notice of Initiation is a public document accessible to all importers. Furthermore, as interested parties in the investigation, importers have access to the non-confidential version of the complaint and the non-confidential file. Therefore, the Commission considered that, on this basis, importers, who are experienced professionals, were aware, or should have been aware, of the alleged dumping practices, the extent thereof and the alleged injury. (5)

                     (12)

                     It thus concluded that the first criterion for registration was met.

               3.2.   Further substantial rise in imports

                     (13)

                     The Commission analysed this criterion on the basis of statistical data available in the Surveillance 2 database, pursuant to the information collected for the product concerned. When analysing import volumes in view of the registration request, complete statistical data were available up to and including November 2019. The Commission considered that the level of imports as from August 2019, the month in which the investigation was initiated, until the most recent period, i.e. November 2019 should be considered and that those volumes should be compared with the volumes of imports during the investigation period. To compare the level of imports during the period August 2019 to November 2019 with the level of imports during the same months in the preceding year was considered inappropriate, as there were no indications on the file that imports of certain hot rolled stainless steel sheets and coils are subject to seasonal fluctuations. Imports from the countries concerned developed as follows:

                        Import volumes from the countries concerned (tonnes)

                                 Origin

                                 Investigation Period (IP)

                                 Monthly average

                                 Post-initiation (*1)

                                 Monthly Average

                                 Δ
                                 IP – post-initiation

                                    PRC

                                 220 705

                                 18 392

                                 110 568

                                 27 642

                                 +50 %

                                    Indonesia

                                 107 107

                                 8 926

                                 9 011

                                 2 253

                                 -75 %

                                    Taiwan

                                 36 542

                                 3 045

                                 13 932

                                 3 483

                                 +14 %

                                    Countries Concerned

                                 364 354

                                 30 363

                                 133 511

                                 33 378

                                 +10 %

                     (14)

                     On the basis of these statistical data, the Commission found that the average monthly volume of imports of certain hot rolled stainless steel sheets and coils from the countries concerned to the Union in the period from September 2019 to November 2019, i.e. after initiation of the case, was 10 % higher than the average monthly volume of imports to the Union during the investigation period.

                     (15)

                     In investigations involving more than one country concerned, whether or not imports from these countries will be cumulated for the purpose of the analysis described in the recitals above, will depend on whether the Commission decides to cumulate these imports in the underlying investigation. The Commission also noted that, in its judgment in Stemcor, the General Court ruled that the ‘further substantial rise in imports’ within the meaning of Article 10(4)(d) of the basic regulation must be assessed as a whole, in order to determine whether the imports, taken as a whole, are likely to seriously undermine the remedial effect of the definitive duties and thus create additional injury for the Union industry, without considering the individual and subjective position of the importers in question (6). As the above table shows, there is no question as to whether the cumulated imports from the countries concerned have shown a further substantial rise.

                     (16)

                     Marcegaglia argued that a further substantial rise in imports was not evidenced in the complainant’s submission and was unlikely to occur because the applicable safeguard tariff quotas (‘the quotas’) on certain steel products (7), which, inter alia, cover the product concerned, are set at levels, for each of the countries concerned, significantly below the export volumes observed during the investigation period. Any quantity imported in excess of the quotas will be subject to a safeguard duty of 25 %. Therefore, imports of the product concerned are, according to Marcegaglia, likely to decrease to the level set by the quotas, which is 25 % below the import volume observed in the investigation period. Marcegaglia added that although in July and August 2019, or, in general, in any given month, the volume of imports (could) exceed these monthly averages, this should not warrant the conclusion that imports are likely to increase.

                     (17)

                     The Commission recalls that the quotas in question are tariff quotas, which provide that any import made beyond the threshold set by them is not prohibited but is subject to an additional ad valorem duty rate of 25 %. This means that importers are allowed to import volumes well beyond the applicable thresholds, subject to the payment of the safeguard duty. In any event, the fact that the product concerned is subject to tariff-rate quotas is linked to the need to avoid serious injury for the Union industry to materialise. The same increase in imports after the initiation of the current investigation may lead to the need for retroactive collection of the eventual duties because of the material injury found and the need for an effective remedy. Moreover, in view of the dumping and injury margins that have been estimated by the complainant (see recital (30) below), the 25 % safeguard duty may not be sufficient to remedy the full extent of dumping and injury. Subsequently, a duty of 25 % will in all likelihood not deter importers from importing additional volumes.

                     (18)

                     Further in response to Marcegaglia’s comments, the Commission also recalls that the present Regulation concerns the registration of imports and is without prejudice to the decision as to whether or not anti-dumping duties will be collected, which is only taken at the stage of any definitive measures.

                     (19)

                     Therefore, in view of the further substantial rise in imports from the countries concerned, the Commission concluded that the second criterion for registration was also met.

               3.3.   Undermining of the remedial effect of the duty

                     (20)

                     The Commission has at its disposal sufficient evidence at this stage that additional injury has already been caused by the continuing rise in imports at further decreasing prices.

                     (21)

                     As established in recitals (14) and (15), there is sufficient evidence of a substantial rise in imports of the product concerned.

                     (22)

                     In addition, there is no evidence on the file that import prices have gone up since the initiation of the investigation. To the contrary, according to the publicly available Surveillance 2 database, the average unit value of the product concerned of imports from the countries concerned was 1 % lower in the period August to November 2019 when compared to the investigation period.

                     (23)

                     Furthermore, in its request for registration, the complainant pointed at the fact that the swiftly deteriorating situation of the Union industry observed in the complaint during the second half of 2018 continued in the first half of 2019, with a further decrease in production levels and increased undercutting by the imports. In the request it also provided evidence showing that the situation had gone from bad to worse since then, inter alia, pointing at four major announcements of restructuring of different kinds by the various Union manufacturers since July 2019, affecting the jobs of hundreds of their staff.

                     (24)

                     On that basis, the timing of the further substantial rise of imports as explained in recitals (14) and (15) is already seriously undermining the remedial effect of any definitive duty, unless such duty would be applied retroactively.

                     (25)

                     The Commission therefore concluded that the third criterion for registration for the dumping part of the request was also met.

               4.   PROCEDURE

                     (26)

                     Therefore, the Commission has concluded that there is sufficient evidence to justify making the imports of the product concerned subject to registration in accordance with Article 14(5) of the basic Regulation.

                     (27)

                     All interested parties are invited to make their views known in writing and to provide supporting evidence. Furthermore, the Commission may hear interested parties, provided that they make a request in writing and show that there are particular reasons why they should be heard.

               5.   REGISTRATION

                     (28)

                     Pursuant to Article 14(5) of the basic Regulation imports of the product concerned should be made subject to registration for the purpose of ensuring that, should the investigation result in findings leading to the imposition of anti-dumping and/or countervailing duties, those duties can, if the necessary conditions are fulfilled, be levied retroactively on the registered imports in accordance with the applicable legal provisions.

                     (29)

                     Any future liability would emanate from the findings of this investigation. At this stage, it is not possible to estimate the amount of potential liability.

                     (30)

                     With regard to imports from the PRC, the allegations in the complaint requesting the initiation of an anti-dumping investigation estimate an average dumping margin of 54,3 % and an average underselling margin of 29,1 % for the product concerned. The amount of possible future liability could be set at the lower of those levels, namely 29,1 % as a proportion of the CIF import value of the product concerned. However, should the Commission find that the conditions of Article 7(2a) and 7(2b) of the basic Regulation are met, namely the dumping margin could be considered to reflect the injury suffered by the Union industry, the amount of possible future liability could be set at the level of the dumping margin of 54,3 %, in accordance with Article 9(4) of the basic Regulation. With regard to imports from Indonesia, the allegations in the complaint requesting the initiation of an anti-dumping investigation estimate an average dumping margin of 32,2 % and an average underselling margin of 39,8 % for the product concerned. The amount of possible future liability is set at the lower of those levels, namely 32,2 % as a proportion of the CIF import value of the product concerned. Should the Commission find that the conditions of Article 7(2a) and 7(2b) of the basic Regulation are met, namely that the dumping margin could be considered to reflect the injury suffered by the Union industry, the amount of possible future liability could be set at the level of the dumping margin. With regard to imports from Taiwan, the allegations in the complaint requesting the initiation of an anti-dumping investigation estimate an average dumping margin of 15,1 % and an average underselling margin of 20,7 % for the product concerned. The amount of possible future liability is set at the lower of those levels, namely 15,1 % as a proportion of the CIF import value of the product concerned.

               6.   PROCESSING OF PERSONAL DATA

                     (31)

                     Any personal data collected in the context of this registration will be treated in accordance with Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (8),

               HAS ADOPTED THIS REGULATION:

            Article 1
            The customs authorities are hereby directed, pursuant to Article 14(5) of Regulation (EU) 2016/1036, to take the appropriate steps to register imports into the Union of flat-rolled products of stainless steel, whether or not in coils (including products cut-to-length and narrow strip), not further worked than hot-rolled and excluding products, not in coils, of a width of 600 mm or more and of a thickness exceeding 10 mm, currently falling under HS codes 7219 11, 7219 12, 7219 13, 7219 14, 7219 22, 7219 23, 7219 24, 7220 11 and 7220 12 and originating in the People’s Republic of China, Taiwan and Indonesia.
            Registration shall expire nine months following the date of entry into force of this Regulation.
            All interested parties are invited to make their views known in writing, to provide supporting evidence or to request to be heard within 21 days from the date of publication of this Regulation.

            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, 23 January 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 176, 30.6.2016, p. 21.

            (2)  Notice of initiation of an anti-dumping proceeding concerning imports of certain hot rolled stainless steel sheets and coils originating in the People’s Republic of China, Taiwan and Indonesia (2019/C 269 I/01) (OJ C 269 I, 12.8.2019, p. 1).

            (3)  Notice of initiation of an anti-subsidy proceeding concerning imports of certain hot rolled stainless steel sheets and coils originating in the People’s Republic of China and Indonesia (2019/C 342/09) (OJ C 342, 10.10.2019, p. 18).

            (4)  OJ L 176, 30.6.2016, p. 55.

            (5)  See judgment of the General Court (Second Chamber) of 8 May 2019 in T-749/16, Stemcor vs European Commission, paragraph 56.

            (*1)  August 2019 – November 2019

            Source: Surveillance 2 database

            (6)  Judgment of the General Court (Second Chamber) of 8 May 2019 in T-749/16, Stemcor vs European Commission, paragraph 86.

            (7)  Commission Implementing Regulation (EU) 2019/159 of 31 January 2019 imposing definitive safeguard measures against imports of certain steel products (OJ L 31, 1.2.2019, p. 27), as amended by Commission Implementing Regulation (EU) 2019/1590 (OJ L 248, 27.9.2019, p. 28).

            (8)  OJ L 295, 21.11.2018, p. 39.


title: Commission Implementing Regulation (EU) 2020/148 of 3 February 2020 concerning the authorisation of robenidine hydrochloride (Robenz 66G) as a feed additive for chickens for fattening and amending Regulation (EC) No 1800/2004 (holder of authorisation Zoetis SA) (Text with EEA relevance)

text:
                  5.2.2020

                  EN

                  Official Journal of the European Union

                  L 33/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/148
         of 3 February 2020
         concerning the authorisation of robenidine hydrochloride (Robenz 66G) as a feed additive for chickens for fattening and amending Regulation (EC) No 1800/2004 (holder of authorisation Zoetis SA)
         (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(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

                     (2)

                     The preparation of robenidine hydrochloride (Robenz 66G) was authorised, in accordance with Directive 70/524/EEC, as a feed additive for chickens for fattening by Commission Regulation (EC) No 1800/2004 (3). That preparation was subsequently entered in the Register of feed additives as an existing product, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

                     (3)

                     In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, an application was submitted for the re-evaluation of robenidine hydrochloride (Robenz 66G) as a feed additive for chickens for fattening. The applicant requested that additive to be classified in the additive category ‘coccidiostats and histomonostats’. 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 24 January 2019 (4) that, under the proposed conditions of use, robenidine hydrochloride (Robenz 66G) does not have an adverse effect on animal health, human health or the environment. The Authority considered that the additive has the potential to effectively control coccidiosis in chickens for fattening. The Authority considered that there is a need for a field post-market monitoring of Eimeria spp., preferably during the latter part of the period of the authorisation. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

                     (5)

                     The assessment of robenidine hydrochloride (Robenz 66G) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.

                     (6)

                     As a consequence of this re-evaluation, Regulation (EC) No 1800/2004 should be amended accordingly.

                     (7)

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

                     (8)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The preparation specified in the Annex, belonging to the additive category ‘coccidiostats and histomonostats’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

            Article 2
            Regulation (EC) No 1800/2004 is amended as follows:

                        (1)

                        Article 2 is deleted;

                        (2)

                        the Annex is deleted.

            Article 3
            The preparation specified in the Annex and feed containing that preparation, which are produced and labelled before 25 August 2020 in accordance with the rules applicable before 25 February 2020 may continue to be placed on the market and used until the existing stocks are exhausted.

            Article 4
            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, 3 February 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

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

            (3)  Commission Regulation (EC) No 1800/2004 of 15 October 2004 concerning the authorisation for 10 years of the additive Cycostat 66G in feedingstuffs, belonging to the group of coccidiostats and other medicinal substances (OJ L 317, 16.10.2004, p. 37).

            (4)  EFSA Journal 2019; 17(3):5613.

            ANNEX

                           Identification number of additive

                           Name of the holder of authorisation

                           Additive (Trade name)

                           Composition, chemical formula, description

                           Species or category of animal

                           Maximum age

                           Minimum content

                           Maximum content

                           Other provisions

                           End of period of authorisation

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

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

                           Additive category: Coccidiostats and histomonostats

                        5a758

                        Zoetis SA

                        Robenidine
                        hydrochloride
                        (Robenz 66G)

                           Additive composition:
                        Robenidine hydrochloride: 66 g/kg
                        Lignosulfonate: 40 g/kg
                        Calcium sulfate dihydrate: 894 g/kg

                        Chickens for fattening

                        —

                        36

                        36

                                    1.

                                    Use of the additive prohibited at least five days before slaughter.

                                    2.

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

                                    3.

                                    The additive shall not be mixed with other coccidiostats.

                                    4.

                                    Post-market monitoring programmes shall be carried out by the holder of authorisation for: resistance to bacteria and Eimeria spp.

                                    5.

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

                        25 February 2030

                        800 μg robenidine hydrochloride/kg of wet liver.
                        350 μg robenidine hydrochloride/kg of wet kidney.
                        200 μg robenidine hydrochloride/kg of wet muscle.
                        1300 μg robenidine hydrochloride/kg of wet skin/fat.

                           Active substance:
                        Robenidine hydrochloride, C15H13Cl2N5
                           .HCl,
                        1,3-bis[(p-chlorobenzylidene) amino]-
                        guanidine hydrochloride (97 %)
                        CAS number: 25875-50-7,
                        Related impurities:

                                    —

                                    N,N’,N"-tris[(p-chlorobenzylidene) amino]guanidine (TRIS) ≤ 0,5 %

                                    —

                                    bis-(4-chlorobenzylidene)hydrazine (AZIN) ≤ 0,5 %

                                    —

                                    unknown impurity ≤ 1 % (individual unknown impurity ≤ 0,2 %)

                           Analytical method
                            (1)

                        For the quantification of robenidine hydrochloride in the feed additive and premixtures: High Performance Liquid Chromatography coupled to Ultraviolet detection (HPLC-UV)
                        For the quantification of robenidine hydrochloride in feedingstuffs: High Performance Liquid Chromatography coupled to Ultraviolet detection (HPLC-UV) – Commission Regulation (EC) No 152/2009
                        For the quantification of robenidine hydrochloride in tissues: Reversed-Phase High Performance Liquid Chromatography coupled to a triple quadrupole mass spectrometer (RP-HPLC-MS/MS) or any equivalent methods complying with the requirements set by Commission Decision 2002/657/EC.

               (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) 2020/149 of 4 February 2020 concerning the renewal of the authorisation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for lambs and horses and repealing Regulations (EC) No 1293/2008 and (EC) No 910/2009 (holder of authorisation Danstar Ferment AG represented in the Union by Lallemand SAS) (Text with EEA relevance)

text:
                  5.2.2020

                  EN

                  Official Journal of the European Union

                  L 33/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/149
         of 4 February 2020
         concerning the renewal of the authorisation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for lambs and horses and repealing Regulations (EC) No 1293/2008 and (EC) No 910/2009 (holder of authorisation Danstar Ferment AG represented in the Union by Lallemand SAS)
         (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 and renewing such authorisation.

                     (2)

                        Saccharomyces cerevisiae CNCM I-1077 was authorised for 10 years as a feed additive for lambs by Commission Regulation (EC) No 1293/2008 (2) and as a feed additive for horses by Commission Regulation (EC) No 910/2009 (3).

                     (3)

                     An application was submitted by the holder of that authorisation for the renewal of the authorisation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for lambs and horses, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 26 February 2019 (4) that the applicant has provided data demonstrating that the additive complies with the conditions for authorisation. The Authority concluded that Saccharomyces cerevisiae CNCM I-1077 remains safe under the authorised conditions of use for the target animals, consumers, users and the environment. The Authority also concluded that the additive is considered an eyes irritant. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

                     (5)

                     The assessment of Saccharomyces cerevisiae CNCM I-1077 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation.

                     (6)

                     As a consequence of the renewal of the authorisation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulations (EC) No 1293/2008 and (EC) No 910/2009 should be repealed.

                     (7)

                     Since safety reasons do not require the immediate application of the amendments made by this Regulation, it is appropriate to provide for a transitional period during which the existing stocks of the preparation of Saccharomyces cerevisiae CNCM I-1077, which are in conformity with the provisions applying before the date of entry into force of this Regulation, may continue to be placed on the market and used until they are exhausted.

                     (8)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional groups ‘gut flora stabilisers’ for lambs and ‘digestibility enhancers’ for horses, is renewed subject to the conditions laid down in that Annex.

            Article 2
            Regulations (EC) No 1293/2008 and (EC) No 910/2009 are repealed.

            Article 3

               Saccharomyces cerevisiae CNCM I-1077, as set out in Regulation (EC) No 910/2009, premixtures and compound feed containing that substance, which are produced and labelled before 25 February 2020 in accordance with the rules applicable before 25 February 2020 may continue to be placed on the market and used until the existing stock are exhausted.

            Article 4
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 4 February 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Regulation (EC) No 1293/2008 of 18 December 2008 concerning the authorisation of a new use of Saccharomyces cerevisiae CNCM I-1077 (Levucell SC20 and Levucell SC10 ME) as a feed additive (OJ L 340, 19.12.2008, p. 38).

            (3)  Commission Regulation (EC) No 910/2009 of 29 September 2009 concerning the authorisation of a new use of the preparation of Saccharomyces cerevisiae CNCM I-1077 as a feed additive for horses (holder of authorisation Danstar Ferment AG represented in the Union by Lallemand SAS) (OJ L 257, 30.9.2009, p. 7).

            (4)  EFSA Journal 2019;17(3):5639.

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method

                        Species or category of animal

                        Maximum age

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

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

                           Category of zootechnical additives. Functional group: digestibility enhancers

                        4b1711

                        Danstar Ferment AG represented by Lallemand SAS

                           Saccharomyces cerevisiae CNCM I-1077

                           Additive composition:

                        Preparation of Saccharomyces cerevisiae CNCM I-1077 containing a minimum of:

                                    —

                                    1 × 1010 CFU/g of additive (coated form);

                                    —

                                    2 × 1010 CFU/g of additive (not-coated form);

                           Characterisation of the active substance

                        Viable cells of Saccharomyces cerevisiae CNCM I-1077

                           Analytical method
                            (1)

                        Enumeration: pour plate method using chloramphenicol dextrose yeast extract agar (EN15789:2009)
                        Identification: polymerase chain reaction (PCR) method (CEN/TS 15790:2008)

                        Horses

                        -

                        3,0 × 109

                        -

                                    1.

                                    In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

                                    2.

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

                        25.2.2030

                           Category of zootechnical additives. Functional group: gut flora stabilisers

                        4b1711

                        Danstar Ferment AG represented by Lallemand SAS

                           Saccharomyces cerevisiae CNCM I-1077

                           Additive composition

                        Preparation of Saccharomyces cerevisiae CNCM I-1077 containing a minimum of:

                                    —

                                    1 × 1010 CFU/g of additive (coated form);

                                    —

                                    2 × 1010 CFU/g of additive (not-coated form);

                           Characterisation of the active substance

                        Viable cells of Saccharomyces cerevisiae CNCM I-1077

                           Analytical method
                            (1)

                        Enumeration: pour plate method using chloramphenicol dextrose yeast extract agar (EN15789:2009)
                        Identification: polymerase chain reaction (PCR) method (CEN/TS 15790:2008)

                        Lambs

                        -

                        3,0 × 109

                                    1.

                                    In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

                                    2.

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

                        25.2.2030

               (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) 2020/151 of 4 February 2020 concerning the authorisation of Pediococcus acidilactici CNCM I-4622 as a feed additive for all porcine species for fattening and for breeding other than sows, all avian species, all fish species and all crustaceans and repealing Regulations (EC) No 911/2009, (EU) No 1120/2010 and (EU) No 212/2011 and Implementing Regulations (EU) No 95/2013, (EU) No 413/2013 and (EU) 2017/2299 (holder of authorisation Danstar Ferment AG represented in the Union by Lallemand SAS) (Text with EEA relevance)

text:
                  5.2.2020

                  EN

                  Official Journal of the European Union

                  L 33/12

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/151
         of 4 February 2020
         concerning the authorisation of Pediococcus acidilactici CNCM I-4622 as a feed additive for all porcine species for fattening and for breeding other than sows, all avian species, all fish species and all crustaceans and repealing Regulations (EC) No 911/2009, (EU) No 1120/2010 and (EU) No 212/2011 and Implementing Regulations (EU) No 95/2013, (EU) No 413/2013 and (EU) 2017/2299 (holder of authorisation Danstar Ferment AG represented in the Union by Lallemand SAS)
         (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 and renewing such authorisation.

                     (2)

                        Pediococcus acidilactici CNCM I-4622 (former Pediococcus acidilactici CNCM MA 18/5M) was authorised for 10 years as a feed additive for salmonids and shrimps by Commission Regulation (EC) No 911/2009 (2), for weaned piglets by Commission Regulation (EU) No 1120/2010 (3), for laying hens by Commission Regulation (EU) No 212/2011 (4), for all fish other than salmonids by Commission Implementing Regulation (EU) No 95/2013 (5), for weaned piglets, pigs for fattening, laying hens and chickens for fattening by Commission Implementing Regulation (EU) No 413/2013 (6), for pigs for fattening, minor porcine species (weaned and for fattening), chickens for fattening, minor poultry species for fattening and minor poultry species for laying by Commission Implementing Regulation (EU) 2017/2299 (7).

                     (3)

                     In accordance with Article 14 of Regulation (EC) No 1831/2003, in conjunction with Article 7 thereof, an application was submitted by the holder of the authorisation of Pediococcus acidilactici CNCM I-4622 as a feed additive for the renewal of the authorisation for chickens for fattening, minor avian species for fattening, laying hens, minor avian species for laying, weaned piglets, pigs for fattening, minor porcine species (weaned) and for fattening, all fish and shrimp, and for a new authorisation for chickens reared for laying and for breeding purposes, for ornamental birds and other non-food producing birds, for turkeys for fattening, for turkeys reared for breeding purposes, for turkeys for breeding purposes, for chickens for breeding purposes and related minor poultry species and other ornamental and non-food producing birds, for suckling piglets and related minor porcine species, for all crustaceans, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Articles 7(3) and 14(2) of that Regulation

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 2 April 2019 (8) that the applicant has provided data demonstrating that the additive complies with the conditions of authorisation. The Authority confirmed its previous conclusions that Pediococcus acidilactici CNCM I-4622 is considered safe for the target species, consumers of products from animals fed with the additive and the environment. It also concluded that there is a potential for users to be exposed via inhalation and that no conclusion could be drawn on the potential for skin and eyes irritancy and dermal sensitisation. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. It also concluded that the additive is efficacious for chickens reared for laying, chickens reared for breeding, chickens for breeding, turkeys and minor avian species reared for laying/breeding and for breeding, and for suckling piglets and minor porcine species for breeding and for fattening and all crustaceans.

                     (5)

                     The assessment of Pediococcus acidilactici CNCM I-4622 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation.

                     (6)

                     As a consequence of the renewal of the authorisation of Pediococcus acidilactici CNCM I-4622 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulations (EC) No 911/2009, (EU) No 1120/2010 and (EU) No 212/2011 and Implementing Regulations (EU) No 95/2013, (EU) No 413/2013 and (EU) 2017/2299 should be repealed.

                     (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 authorisation of the additive specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘gut flora stabilisers’ for all porcine species for fattening and for breeding other than sows, all birds, and to the functional group ‘other zootechnical additives’ for all fish and all crustaceans is renewed subject to the conditions laid down in that Annex.

            Article 2
            Regulations (EC) No 911/2009, (EU) No 1120/2010 and (EU) No 212/2011, as well as Implementing Regulations (EU) No 95/2013, (EU) No 413/2013 and (EU) 2017/2299 are repealed.

            Article 3
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 4 February 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Regulation (EC) No 911/2009 of 29 September 2009 concerning the authorisation of a new use of the preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for salmonids and shrimps (holder of authorisation Danstar Ferment AG) (OJ L 257, 30.9.2009, p. 10).

            (3)  Commission Regulation (EU) No 1120/2010 of 2 December 2010 concerning the authorisation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for weaned piglets (holder of the authorisation Danstar Ferment AG) (OJ L 317, 3.12.2010, p. 12).

            (4)  Commission Regulation (EU) No 212/2011 of 3 March 2011 concerning the authorisation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for laying hens (holder of authorisation Danstar Ferment AG (OJ L 59, 4.3.2011, p. 1).

            (5)  Commission Implementing Regulation (EU) No 95/2013 of 1 February 2013 concerning the authorisation of a preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for all fish other than salmonids (holder of authorisation Danstar Ferment AG) (OJ L 33, 2.2.2013, p. 19).

            (6)  Commission Implementing Regulation (EU) No 413/2013 of 6 May 2013 concerning the authorisation of a preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for use in water for drinking for weaned piglets, pigs for fattening, laying hens and chickens for fattening (holder of authorisation Danstar Ferment AG) (OJ L 125, 7.5.2013, p. 1).

            (7)  Commission Implementing Regulation (EU) 2017/2299 of 12 December 2017 concerning the authorisation of a preparation of Pediococcus acidilactici CNCM MA 18/5M as a feed additive for pigs for fattening, minor porcine species (weaned and for fattening), chickens for fattening, minor poultry species for fattening and minor poultry species for laying, the authorisation of that feed additive for use in water for drinking and amending Regulations (EC) No 2036/2005, (EC) No 1200/2005 and Implementing Regulation (EU) No 413/2013 (holder of authorisation Danstar Ferment AG represented by Lallemand SAS) (OJ L 329, 13.12.2017, p. 33).

            (8)  EFSA Journal 2019;17(4):5691 and EFSA Journal 2019;17(5):5690.

            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

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

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

                        CFU/l of water for drinking

                           Category of zootechnical additives. Functional group: gut flora stabilisers

                        4d1712

                        Danstar Ferment AG represented in the Union by Lallemand SAS

                           Pediococcus acidilactici CNCM I-4622

                           Additive composition

                        Preparation of Pediococcus acidilactici CNCM I-4622
                        containing a minimum of 1 × 1010 CFU/g
                        Solid not-coated and coated forms

                        All porcine species for fattening and for breeding, other than sows

                        -

                        1 x 109

                        -

                        5 x 108

                        -

                                    1.

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

                                    2.

                                    For use of the additive in water for drinking the homogenous dispersion of the additive shall be ensured.

                                    3.

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

                        25 February 2030

                           Characterisation of the active substance

                        Viable cells of Pediococcus acidilactici CNCM I-4622

                        All avian species

                           Analytical method
                            (1)

                        Enumeration of the active substance in feed additive, premixtures, feedingstuffs and water: spread plate
                        method using MRS agar (EN 15786:2009).
                        Identification: Pulsed Field Gel Electrophoresis (PFGE) method.

                           Category of zootechnical additives. Functional group: other zootechnical additives (favourably affect growth)

                        4d1712

                        Danstar Ferment AG represented in the Union by Lallemand SAS

                           Pediococcus acidilactici CNCM I-4622

                           Additive composition

                        Preparation of Pediococcus acidilactici CNCM I-4622 containing a minimum of 1 × 1010 CFU/g

                        All fish spicies

                        -

                        1 x 109

                        -

                        -

                                    1.

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

                                    2.

                                    The additive shall only be used in solid feed.

                                    3.

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

                           Characterisation of the active substance

                        Viable cells of Pediococcus acidilactici CNCM I-4622

                        All crustaceans

                           Analytical method

                        Enumeration of the active substance in feed additive, premixtures, feedingstuffs and water: spread plate
                        method using MRS agar (EN 15786:2009).
                        Identification: Pulsed Field Gel Electrophoresis (PFGE) method.

               (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