title: Commission Implementing Regulation (EU) 2019/923 of 3 June 2019 concerning the classification of certain goods in the Combined Nomenclature

text:
                  6.6.2019

                  EN

                  Official Journal of the European Union

                  L 148/7

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/923
         of 3 June 2019
         concerning the classification of certain goods in the Combined Nomenclature
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 952/2013 of the European Parliament and of the Council of 9 October 2013 laying down the Union Customs Code (1), and in particular Article 57(4) and Article 58(2) thereof,
         Whereas:

                     (1)

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

                     (2)

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

                     (3)

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

                     (4)

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

                     (5)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The goods described in column (1) of the table set out in the Annex shall be classified within the Combined Nomenclature under the CN codes indicated in column (2) of that table.

            Article 2
            Binding tariff information which does not conform to this Regulation may continue to be invoked in accordance with Article 34(9) of Regulation (EU) No 952/2013 for a period of three months from the date of entry into force of this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 3 June 2019.

                  For the Commission,

                  On behalf of the President,

               Stephen QUEST

                  Director-General

                  Directorate-General for Taxation and Customs Union

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

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

            ANNEX

                        Description of the goods

                        Classification
                        (CN code)

                        Reasons

                        (1)

                        (2)

                        (3)

                                    1.

                                    A product consisting of an alcoholic liquid with an alcoholic strength by volume of 4 % to 6 %.
                                    It is produced by mixing a fermented apple juice with distilled ethyl alcohol, carbonated water, sugar, citric acid, flavourings, a preservative agent (E 202), caffeine and colouring agents (E 102, E 124).
                                    The addition of distilled ethyl alcohol to the fermented apple juice increases its alcoholic strength: 62,05 litres of fermented apple juice at 18 % vol. (11,17 litres of alcohol) are mixed with 37,95 litres of distilled ethyl alcohol at 28,28 % vol. (10,73 litres of alcohol). The fermented alcohol component in the product accounts for 51 % and the distilled alcohol accounts for 49 % of the total alcohol content.
                                    Τhe resulting mixture is diluted to a drinking strength of 4 % to 6 % vol. by adding carbonated water. Sugar, citric acid, a preservative agent (E 202), caffeine, colouring agents (E 102, E 124) and flavourings (for instance mango, rum, passion fruit or port) are added as well.
                                    The product is presented to be used for the production of cocktails. The smell and taste are alcoholic, acidic and sweet.
                                    The product is for human consumption and is put up for retail sale in containers holding two litres or less.

                        2208 90 69

                        Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature and the wording of CN codes 2208 , 2208 90  and 2208 90 69 .
                        The product is an alcoholic beverage that has not retained the character of a product falling under heading 2206  (see also the Harmonized System Explanatory Notes to heading 2206 , third paragraph) as the added substances have led to a loss of the properties and characteristics of a fermented apple juice.
                        The fact that the distilled alcohol does not exceed, either in volume or percentage, 49 % of the alcohol present in the product, with the remaining 51 % resulting from a process of fermentation, is not a classification criterion as there is no majority rule by percentages that determines the character of products of heading 2206 .
                        Consequently, classification under heading 2206  is excluded as the product shows objective characteristics similar to those of a spirituous beverage and not anymore those obtained by fermentation of a specific fruit or plant.
                        The product is therefore to be classified under CN code 2208 90 69  as other spirituous beverage in containers holding two litres or less.

                                    2.

                                    A product consisting of an alcoholic liquid with an alcoholic strength by volume of 15 %.
                                    It is produced by fermenting a sugar beet extract, consisting by weight of 93,4 % sucrose (96,7 % sucrose in dry matter), protein, trace minerals, fibre and water.
                                    The fermentation process is achieved by the addition of water and yeast, and it proceeds until an alcohol content of 15 % has been reached. The yeast is then removed by sedimentation and microfiltration. The product has no specific smell and taste except that of alcohol.
                                    The product is intended to be used as a base in the formulation of alcoholic beverages.
                                    It is presented in bulk.

                        2208 90 99

                        Classification is determined by general rules 1 and 6 for the interpretation of the Combined Nomenclature and the wording of CN codes 2208 , 2208 90  and 2208 90 99 .
                        Sugar beet extract is neutral raw sugar and therefore the product cannot have the taste, smell and/or appearance of a beverage produced from a particular fruit or natural product. Consequently, it has not obtained the characteristics of a product falling under heading 2206  but acquired those of ethyl alcohol of heading 2208 .
                        The product, which is obtained through processing a fermented sugar beet extract and is intended to be used as a base in the formulation of alcoholic beverages, being neutral in terms of colour, smell and taste as a result of purification (including microfiltration), falls therefore under heading 2208 .
                        The product is therefore to be classified under CN code 2208 90 99  as other undenaturated ethyl alcohol in containers holding more than two litres.


title: Commission Implementing Regulation (EU) 2019/1090 of 26 June 2019 concerning the non-renewal of approval of the active substance dimethoate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (Text with EEA relevance.)

text:
                  27.6.2019

                  EN

                  Official Journal of the European Union

                  L 173/39

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1090
         of 26 June 2019
         concerning the non-renewal of approval of the active substance dimethoate, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 20(1) and Article 78(2) thereof,
         Whereas:

                     (1)

                     Commission Directive 2007/25/EC (2) included dimethoate as an active substance in Annex I to Council Directive 91/414/EEC (3).

                     (2)

                     Active substances included in Annex I to Directive 91/414/EEC are deemed to have been approved under Regulation (EC) No 1107/2009 and are listed in Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (4).

                     (3)

                     The approval of the active substance dimethoate, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011, expires on 31 July 2020.

                     (4)

                     An application for the renewal of the approval of dimethoate was submitted in accordance with Article 1 of Commission Implementing Regulation (EU) No 844/2012 (5) within the time period provided for in that Article.

                     (5)

                     The applicant submitted the supplementary dossiers required in accordance with Article 6 of Implementing Regulation (EU) No 844/2012. The application was found to be complete by the rapporteur Member State.

                     (6)

                     The rapporteur Member State prepared a renewal assessment report in consultation with the co-rapporteur Member State and submitted it to the European Food Safety Authority (‘the Authority’) and the Commission on 5 May 2017.

                     (7)

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

                     (8)

                     On 2 October 2018 the Authority communicated to the Commission its conclusion (6) on whether dimethoate can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009. The Commission presented to the Standing Committee on Plants, Animal, Food and Feed the draft renewal report for dimethoate on 13 December 2018 and the draft regulation on 25 January 2019.

                     (9)

                     The Authority identified specific concerns. In particular, it was not possible to exclude exposure risk to consumers, operators, workers, bystanders and residents due to their exposure to residues of dimethoate, for which the genotoxic potential could not be excluded, and its main metabolite omethoate which was concluded to be an in vivo mutagenic agent by the majority of experts in the peer review. Furthermore, the Authority concluded that a high risk to mammals, and to non-target arthropods for dimethoate. and to honeybees for both dimethoate and omethoate was concluded for all the assessed representative uses. In addition, the Authority concluded that the technical specification, whether the current or the revised one, is not supported by the (eco) toxicological assessment

                     (10)

                     The Commission invited the applicant to submit its comments on the conclusion of the Authority. Furthermore, in accordance with third subparagraph of Article 14(1) of Implementing Regulation (EU) No 844/2012, the Commission invited the applicant to submit comments on the draft renewal report. The applicant submitted their comments, which have been carefully examined.

                     (11)

                     However, despite the arguments put forward by the applicant, the concerns regarding the active substance could not be eliminated.

                     (12)

                     Consequently, it has not been established with respect to one or more representative uses of at least one plant protection product that the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 are satisfied. The approval of the active substance dimethoate should therefore not be renewed.

                     (13)

                     Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

                     (14)

                     Member States should be provided with sufficient time to withdraw authorisations for plant protection products containing dimethoate.

                     (15)

                     For plant protection products containing dimethoate, where Member States grant any grace period in accordance with Article 46 of Regulation (EC) No 1107/2009, that period should, at the latest, expire on 17 October 2019 for plant protection products used on cherries and on 17 July 2020 for plant protection products used on other crops.

                     (16)

                     Commission Implementing Regulation (EU) 2019/707 (7) extended the approval period of dimethoate to 31 July 2020 in order to allow the renewal process to be completed before the expiry of the approval period of that substance. Given that a decision on the non-renewal of the approval has been taken ahead of that extended expiry date, this Regulation should apply as soon as possible.

                     (17)

                     This Regulation does not prevent the submission of a further application for the approval of dimethoate pursuant to Article 7 of Regulation (EC) No 1107/2009.

                     (18)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Non-renewal of approval of active substance
            The approval of the active substance dimethoate is not renewed.

            Article 2
            Amendment to Implementing Regulation (EU) No 540/2011
            In Part A of the Annex to Implementing Regulation (EU) No 540/2011, row 149, on dimethoate, is deleted.

            Article 3
            Transitional measures
            Member States shall withdraw authorisations for plant protection products containing dimethoate as active substance by 17 January 2020 at the latest.

            Article 4
            Grace period
            Any grace period granted by Member States in accordance with Article 46 of Regulation (EC) No 1107/2009 shall be as short as possible and shall expire by 17 October 2019 for plant protection products used on cherries and by 17 July 2020 for plant protection products used on other crops, at the latest.

            Article 5
            Entry into force
            This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 26 June 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Commission Directive 2007/25/EC of 23 April 2007 amending Council Directive 91/414/EEC to include dimethoate, dimethomorph, glufosinate, metribuzin, phosmet and propamocarb as active substances (OJ L 106, 24.4.2007, p. 34).

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

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

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

            (6)  EFSA (European Food Safety Authority), 2018. Conclusion on the peer review of the pesticide risk assessment of the active substance dimethoate EFSA Journal 2018;16(10):5454. https://www.efsa.europa.eu/en/efsajournal/pub/5454

            (7)  Commission Implementing Regulation (EU) 2019/707 of 7 May 2019 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances alpha-cypermethrin, beflubutamid, benalaxyl, benthiavalicarb, bifenazate, boscalid, bromoxynil, captan, cyazofamid, desmedipham, dimethoate, dimethomorph, diuron, ethephon, etoxazole, famoxadone, fenamiphos, flumioxazine, fluoxastrobin, folpet, foramsulfuron, formetanate, metalaxyl-m, methiocarb, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, propamocarb, prothioconazole, s-metolachlor and tebuconazole (OJ L 120, 8.5.2019, p. 16).


title: Commission Implementing Regulation (EU) 2019/1125 of 5 June 2019 concerning the authorisation of zinc chelate of methionine sulfate as a feed additive for all animal species (Text with EEA relevance.)

text:
                  2.7.2019

                  EN

                  Official Journal of the European Union

                  L 177/77

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1125
         of 5 June 2019
         concerning the authorisation of zinc chelate of methionine sulfate as a feed additive for all animal species
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

                     Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.

                     (2)

                     In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of zinc chelate of methionine sulfate. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

                     (3)

                     That application concerns the authorisation of zinc chelate of methionine sulfate as a feed additive for all animal species to be classified in the additive category ‘nutritional additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 18 May 2017 (2) and 4 October 2018 (3) that, under the proposed conditions of use, zinc chelate of methionine sulfate does not have an adverse effect on animal health and consumer safety. It also concluded that the additive is considered as a potential skin sensitizer and an eye and skin irritant and stated a risk for the users of the additive upon inhalation. 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. The Authority also concluded that that additive does not pose an additional risk for the environment compared to other compounds of zinc and that it is an efficacious source of zinc for all animal species. 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 that additive shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are, subject to respective protective measures for the users of the additive, satisfied. Accordingly, the use of that additive should be authorised as specified in the Annex to this Regulation.

                     (6)

                     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 substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 5 June 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  EFSA Journal 2017;15(6):4859.

            (3)  EFSA Journal 2018;16(10):5463.

            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

                        Content of element (Zn) in mg/kg of complete feed with a moisture content of 12 %

                           Category of nutritional additives. Functional group: compounds of trace elements

                        3b614

                        —

                        Zinc chelate of methionine sulfate

                           Additive composition:

                        Zinc chelate of methionine sulfate as a powder with a zinc content between 2 % and 15 %.

                           Characterisation of the active substance:

                        Zinc, 2-amino-4 methylsulfanylbutanoic acid, sulfate; zinc chelated with methionine in a molar ratio 1:1.

                                    Chemical formula: C5H11NO6S2Zn

                                    CAS Number: 56329-42-1

                           Analytical methods
                            (1):
                        For the quantification of total zinc in the feed additive and premixtures:

                                    —

                                    EN 15510: Inductively Coupled Plasma – Atomic Emission Spectrometry (ICP-AES), or

                                    —

                                    EN 15621: Inductively Coupled Plasma – Atomic Emission Spectrometry (ICP-AES) after pressure digestion.

                              For the quantification of methionine content in the feed additive:

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-UV/FD) – EN ISO 17180 or VDLUFA 4.11.6 and EN ISO 13903

                              For the quantification of total zinc in feed materials and compound feed:

                                    —

                                    Regulation (EC) No 152/2009 — Atomic Absorption Spectrometry (AAS); or

                                    —

                                    EN 15510: Inductively Coupled Plasma – Atomic Emission Spectrometry (ICP-AES); or

                                    —

                                    EN 15621: Inductively Coupled Plasma – Atomic Emission Spectrometry (ICP-AES) after pressure digestion.

                        All animal species

                        —

                        —

                        Dogs and cats: 200 (total) Salmonids and milk replacers for calves: 180 (total)
                        Piglets, sows, rabbits and all fish other than salmonids: 150 (total)
                        Other species and categories: 120 (total)

                                    1.

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

                                    2.

                                    Zinc chelate of methionine sulfate may be placed on the market and used as an additive consisting of a preparation.

                                    3.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal contact or eyes contact. Where risks cannot be reduced to an acceptable level by those procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

                        22 July 2029

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


title: Commission Implementing Regulation (EU) 2019/1271 of 25 July 2019 amending Implementing Regulation (EU) 2018/1848 as regards the amount available to Romania for the reimbursement, in accordance with Article 26(5) of Regulation (EU) No 1306/2013 of the European Parliament and of the Council, of the appropriations carried over from financial year 2018

text:
                  30.7.2019

                  EN

                  Official Journal of the European Union

                  L 201/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1271
         of 25 July 2019
         amending Implementing Regulation (EU) 2018/1848 as regards the amount available to Romania for the reimbursement, in accordance with Article 26(5) of Regulation (EU) No 1306/2013 of the European Parliament and of the Council, of the appropriations carried over from financial year 2018
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (1), and in particular Article 26(6) thereof,
         After consulting the Committee on the Agricultural Funds,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) 2018/1848 (2) sets the amounts made available to the Member States for reimbursement to the final recipients in financial year 2019. Those amounts correspond to the financial discipline reduction actually applied by the Member States in financial year 2018 on the basis of the Member States' declarations of expenditure for the period from 16 October 2017 to 15 October 2018.

                     (2)

                     In respect of Romania, the detailed declaration of expenditure did not fully take into account the threshold of EUR 2000 that applies to financial discipline in accordance with Article 8(1) of Regulation (EU) No 1307/2013 of the European Parliament and of the Council (3). Therefore, for reasons of sound financial management, in Implementing Regulation (EU) 2018/1848 no amount was made available to Romania for reimbursement.

                     (3)

                     Romania has subsequently informed the Commission about the correct amount of financial discipline which should have been applied in Romania in financial year 2018 when fully taking into account the threshold of EUR 2 000. In order to ensure that the reimbursement of the relevant amounts to Romanian farmers can take place, the Commission should determine the corresponding amount that is made available to Romania.

                     (4)

                     Implementing Regulation (EU) 2018/1848 should therefore be amended accordingly.

                     (5)

                     As the amendment provided for in this Regulation affects the application of Implementing Regulation (EU) 2018/1848, which applies from 1 December 2018, this Regulation should also apply from that date; therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

               HAS ADOPTED THIS REGULATION:

            Article 1
            In the table set out in the Annex to Implementing Regulation (EU) 2018/1848, the following entry is inserted after the row concerning Portugal:

                           ‘Romania

                           16 669 111 ’

            Article 2
            This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
            It shall apply from 1 December 2018.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 25 July 2019.

                  For the Commission,

                  On behalf of the President,

               Jerzy PLEWA

                  Director-General

                  Directorate-General for Agriculture and Rural Development

            (1)  OJ L 347, 20.12.2013, p. 549.

            (2)  Commission Implementing Regulation (EU) 2018/1848 of 26 November 2018 on the reimbursement, in accordance with Article 26(5) of Regulation (EU) No 1306/2013 of the European Parliament and of the Council, of the appropriations carried over from financial year 2018 (OJ L 300, 27.11.2018, p. 4).

            (3)  Regulation (EU) No 1307/2013 of the European Parliament and of the Council of 17 December 2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and repealing Council Regulation (EC) No 637/2008 and Council Regulation (EC) No 73/2009 (OJ L 347, 20.12.2013, p. 608).


title: Commission Implementing Regulation (EU) 2019/1272 of 29 July 2019 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods and Implementing Decision (EU) 2017/2078 authorising an extension of use of yeast beta-glucans as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (Text with EEA relevance.)

text:
                  30.7.2019

                  EN

                  Official Journal of the European Union

                  L 201/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1272
         of 29 July 2019
         correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods and Implementing Decision (EU) 2017/2078 authorising an extension of use of yeast beta-glucans as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Articles 8 and 12 thereof,
         Whereas:

                     (1)

                     Pursuant to Article 8 of Regulation (EU) 2015/2283, the Commission was to establish, by 1 January 2018, the Union list of novel foods authorised or notified under Regulation (EC) No 258/97 of the European Parliament and of the Council (2).

                     (2)

                     The Union list of novel foods authorised or notified under Regulation (EC) No 258/97 was established by Commission Implementing Regulation (EU) 2017/2470 (3).

                     (3)

                     Commission Implementing Regulation (EU) 2018/1023 (4) corrected Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods in order to include a number of authorised or notified novel foods not included in the initial Union list.

                     (4)

                     After the publication of Implementing Regulation (EU) 2017/2470 and Implementing Regulation (EU) 2018/1023, the Commission identified additional errors in the Annex to Implementing Regulation (EU) 2017/2470.

                     (5)

                     Corrections are needed in order to provide clarity and legal certainty to food business operators and to Member States' competent authorities, thus providing for the proper implementation and use of the Union list of novel foods.

                     (6)

                     On 22 November 2018, the competent authority of Italy made a request to the Commission for the correction in the Union list relating to the designation and the specific labelling requirement of the novel food Echinacea purpurea extract from cell cultures. This novel food was authorised through notification procedure pursuant to Article 5 of Regulation (EC) No 258/97. The competent authority of Italy has made an error by notifying the wrong name for the cell cultures and therefore, the request asks to replace the name of the cell cultures HTN®Vb with the name EchiPure-PC™ in the designation of the novel food as listed in the Union list and in the specific labelling requirement of foods containing it, as well as in the specifications of the novel food.

                     (7)

                     A correction of the designation and of the specific labelling requirement in Table 1 and a correction of the specifications in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 of the novel food Echinacea purpurea extract from cell cultures are therefore necessary.

                     (8)

                     The novel foods yeast beta-glucans were authorised under certain conditions of use by Commission Implementing Decision 2011/762/EU (5). Use of yeast beta-glucans in additional food categories was later authorised by Commission Implementing Decision (EU) 2017/2078 (6). In the specifications of yeast beta-glucans in Implementing Decision (EU) 2017/2078, the measurement units for heavy metals are wrongly expressed in mg/g instead of mg/kg. This error was transferred in the Union list established by Implementing Regulation (EU) 2017/2470. Therefore, the specifications of the yeast beta-glucans relating to heavy metals in Annex I to Implementing Decision (EU) 2017/2078 and in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 should be corrected accordingly.

                     (9)

                     Implementing Regulation (EU) 2017/2470 and Implementing Decision (EU) 2017/2078 should be corrected accordingly.

                     (10)

                     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 Annex to Implementing Regulation (EU) 2017/2470 is corrected in accordance with the Annex to this Regulation.

            Article 2
            Annex I to Implementing Decision (EU) 2017/2078 is corrected in accordance with the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 29 July 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 327, 11.12.2015, p. 1.

            (2)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

            (3)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

            (4)  Commission Implementing Regulation (EU) 2018/1023 of 23 July 2018 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods (OJ L 187, 24.7.2018, p. 1).

            (5)  Commission Implementing Decision 2011/762/EU of 24 November 2011 authorising the placing on the market of yeast beta-glucans as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 313, 26.11.2011, p. 41).

            (6)  Commission Implementing Decision (EU) 2017/2078 of 10 November 2017 authorising an extension of use of yeast beta-glucans as a novel food ingredient under Regulation (EC) No 258/97 of the European Parliament and of the Council (OJ L 295, 14.11.2017, p. 77).

            ANNEX

               (1)
               The Annex to Implementing Regulation (EU) 2017/2470 is corrected as follows:

                           (a)

                           the entry for Echinacea purpurea extract from cell cultures in Table 1 (Authorised novel foods) is replaced by the following:

                                       Authorised novel food

                                       Conditions under which the novel food may be used

                                       Additional specific labelling requirements

                                       Other requirements

                                       ‘
                                             Echinacea purpurea

                                          extract from cell cultures

                                          Specified food category

                                          Maximum levels

                                       The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘dried extract of Echinacea purpurea from cell cultures EchiPure-PC™’’

                                       Food Supplements as defined in Directive 2002/46/EC

                                       In line with normal use in food supplements of a similar extract from florets within the flower head of Echinacea purpurea

                           (b)

                           the entry for Echinacea purpurea extract from cell cultures in Table 2 (Specifications) is replaced by the following:

                                       Authorised novel food

                                       Specification

                                       ‘
                                             Echinacea purpurea

                                          extract from cell cultures

                                          Description/Definition:

                                       Dried extract of Echinacea purpurea from cell cultures EchiPure-PC™’

                           (c)

                           the entries for Yeast beta-glucans in Table 2 (Specifications) under the heading Heavy metals for insoluble in water, but dispersible in many liquid matrices are replaced by the following:

                                       ‘Lead: < 0,2 mg/kg
                                       Arsenic: < 0,2 mg/kg
                                       Mercury: < 0,1 mg/kg
                                       Cadmium: < 0,1 mg/kg’

               (2)
               Annex I to Implementing Decision (EU) 2017/2078 is corrected as follows:
               The entries for Lead, Arsenic, Mercury and Cadmium in the Table Specifications of Yeast (Saccharomyces cerevisiae) beta-glucans are replaced by the following:

                           ‘Lead

                           < 0,2 mg/kg

                           Arsenic

                           < 0,2 mg/kg

                           Mercury

                           < 0,1 mg/kg

                           Cadmium

                           < 0,1 mg/kg’


title: Commission Implementing Regulation (EU) 2019/1667 of 27 September 2019 entering a name in the register of protected designations of origin and protected geographical indications Cârnaţi de Pleşcoi (PGI)

text:
                  4.10.2019

                  EN

                  Official Journal of the European Union

                  L 255/5

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1667
         of 27 September 2019
         entering a name in the register of protected designations of origin and protected geographical indications ‘Cârnaţi de Pleşcoi’ (PGI)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, the application from Romania to register the name ‘Cârnaţi de Pleşcoi’ was published in the Official Journal of the European Union (2).

                     (2)

                     As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Cârnaţi de Pleşcoi’ should therefore be entered in the register,

               HAS ADOPTED THIS REGULATION:

               Article 1

            The name ‘Cârnaţi de Pleşcoi’ (PGI) is hereby entered in the register.
            The name specified in the first paragraph denotes a product in Class 1.2. Meat products (cooked, salted, smoked, etc.) set out in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

               Article 2

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 27 September 2019.

                  For the Commission,

                  On behalf of the President,

               Phil HOGAN

                  Member of the Commission

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

            (2)  OJ C 185, 29.5.2019, p. 14.

            (3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).


title: Commission Implementing Regulation (EU) 2019/1669 of 30 September 2019 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications Olives cassées de la vallée des Baux-de-Provence (PDO)

text:
                  7.10.2019

                  EN

                  Official Journal of the European Union

                  L 256/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1669
         of 30 September 2019
         approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications ‘Olives cassées de la vallée des Baux-de-Provence’ (PDO)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,
         Whereas:

                     (1)

                     Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined France’s application for the approval of amendments to the specification for the protected designation of origin ‘Olives cassées de la vallée des Baux-de-Provence’, registered under Commission Regulation (EC) No 378/1999 (2).

                     (2)

                     Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union (3) as required by Article 50(2)(a) of that Regulation.

                     (3)

                     As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the specification should be approved,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Olives cassées de la vallée des Baux-de-Provence’ (PDO) are hereby approved.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 30 September 2019.

                  For the Commission,

                  On behalf of the President,

               Phil HOGAN

                  Member of the Commission

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

            (2)  Commission Regulation (EC) No 378/1999 of 19 February 1999 supplementing the Annex to Regulation (EC) No 2400/96 on the entry of certain names in the ‘Register of protected designations of origin and protected geographical indications’ provided for in Council Regulation (EEC) No 2081/92 on the protection of geographical indications and designations of origin for agricultural products and foodstuffs (OJ L 46, 20.2.1999, p. 13).

            (3)  OJ C 188, 4.6.2019, p. 12.


title: Commission Implementing Regulation (EU) 2019/1953 of 25 November 2019 on the reimbursement, in accordance with Article 26(5) of Regulation (EU) No 1306/2013 of the European Parliament and of the Council, of the appropriations carried over from financial year 2019

text:
                  27.11.2019

                  EN

                  Official Journal of the European Union

                  L 306/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1953
         of 25 November 2019
         on the reimbursement, in accordance with Article 26(5) of Regulation (EU) No 1306/2013 of the European Parliament and of the Council, of the appropriations carried over from financial year 2019
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (1), and in particular Article 26(6) thereof,
         After consulting the Committee on the Agricultural Funds,
         Whereas:

                     (1)

                     In accordance with point (d) of the first subparagraph of Article 12(2) of Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council (2) non-committed appropriations relating to the actions financed by the European Agricultural Guarantee Fund (EAGF) as referred to in Article 4(1) of Regulation (EU) No 1306/2013 may be carried over to the following financial year. Such carryover is limited to 2 % of the initial appropriations voted by the European Parliament and by the Council and to the amount of the adjustment of direct payments as referred to in Article 8 of Regulation (EU) No 1307/2013 of the European Parliament and of the Council (3) which was applied during the preceding financial year.

                     (2)

                     In accordance with Article 26(5) of Regulation (EU) No 1306/2013, by way of derogation from the third subparagraph of Article 12(2) of Regulation (EU, Euratom) 2018/1046, Member States are to reimburse the carryover referred to in point (d) of the first subparagraph of Article 12(2) of Regulation (EU, Euratom) 2018/1046 to the final recipients who are subject to the adjustment rate in the financial year to which the appropriations are carried over. That reimbursement only applies to final beneficiaries in those Member States where financial discipline applied (4) in the preceding financial year.

                     (3)

                     When setting the amount of the carryover to be reimbursed, in accordance with Article 26(7) of Regulation (EU) No 1306/2013 the amounts of the reserve for crises in the agricultural sector referred to in Article 25 of that Regulation, not made available for crisis measures by the end of the financial year, are to be taken into account.

                     (4)

                     In accordance with Article 1(1) of Commission Implementing Regulation (EU) 2018/1710 (5), financial discipline is applied to direct payments in respect of calendar year 2018 to establish the crisis reserve. The crisis reserve has not been called on in financial year 2019.

                     (5)

                     In order to ensure that the reimbursement to the final recipients of unused appropriations as a result of the application of financial discipline remains proportionate to the amount of the financial discipline adjustment, it is appropriate that the Commission determines the amounts available to the Member States for the reimbursement.

                     (6)

                     To avoid compelling Member States to make an additional payment for that reimbursement, this Regulation needs to apply from 1 December 2019. Consequently, the amounts established by this Regulation are definitive and apply, without prejudice to the application of reductions in accordance with Article 41 of Regulation (EU) No 1306/2013, to any other corrections taken into account in the monthly payment decision concerning the expenditure effected by the paying agencies of the Member States for October 2019, in accordance with Article 18(3) of Regulation (EU) No 1306/2013 and to any deductions and supplementary payments to be made in accordance with Article 18(4) of that Regulation or to any decisions which will be taken within the framework of the clearance of accounts procedure.

                     (7)

                     In accordance with the introductory phrase of Article 12(2) of Regulation (EU, Euratom) 2018/1046 the non-committed appropriations may be carried over to the following financial year only. It is therefore appropriate for the Commission to determine eligibility dates for the expenditure of the Member States in relation to the reimbursement in accordance with Article 26(5) of Regulation (EU) No 1306/2013, taking into account the agricultural financial year as defined in Article 39 of that Regulation.

                     (8)

                     In order to take into account the short time span between the communication of the execution of 2019 EAGF appropriations under shared management for the period from 16 October 2018 to 15 October 2019 by the Member States and the need to apply this Regulation from 1 December 2019, this Regulation should enter into force on the date of its publication in the Official Journal of the European Union,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The amounts of the appropriations that will be carried over from financial year 2019 in accordance with point (d) of the first subparagraph and the third subparagraph of Article 12(2) of Regulation (EU, Euratom) 2018/1046 and that in accordance with Article 26(5) of Regulation (EU) No 1306/2013 are made available to the Member States for the reimbursement to the final recipients who are subject to the adjustment rate in financial year 2020, are laid down in the Annex to this Regulation.
            The amounts that will be carried over are subject to the carryover decision of the Commission in accordance with Article 12(3) of Regulation (EU, Euratom) 2018/1046.

            Article 2
            Member States’ expenditure in relation to the reimbursement of the appropriations carried over shall only be eligible for Union financing if the relevant amounts have been paid to the beneficiaries before 16 October 2020.

            Article 3
            This Regulation shall enter into force on the date of its publication in the Official Journal of the European Union.
            It shall apply from 1 December 2019.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 25 November 2019.

                  For the Commission,

                  On behalf of the President,

               Jerzy PLEWA

                  Director-General

                  Directorate-General for Agriculture and Rural Development

            (1)  OJ L 347, 20.12.2013, p. 549.

            (2)  Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (OJ L 193, 30.7.2018, p. 1).

            (3)  Regulation (EU) No 1307/2013 of the European Parliament and of the Council of 17 December 2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and repealing Council Regulation (EC) No 637/2008 and Council Regulation (EC) No 73/2009 (OJ L 347, 20.12.2013, p. 608).

            (4)  Financial discipline does not apply in financial year 2019 in Croatia in accordance with Article 8(2) of Regulation (EU) No 1307/2013.

            (5)  Commission Implementing Regulation (EU) 2018/1710 of 13 November 2018 adapting the adjustment rate for direct payments pursuant to Regulation (EU) No 1306/2013 of the European Parliament and of the Council in respect of the calendar year 2018 and repealing Commission Implementing Regulation (EU) 2018/866 (OJ L 286, 14.11.2018, p. 10).

            ANNEX

               Amounts available for reimbursement of appropriations carried over

                        (amounts in EUR)

                        Belgium

                        6 075 149

                        Bulgaria

                        9 748 728

                        Czechia

                        11 451 014

                        Denmark

                        10 676 454

                        Germany

                        59 995 488

                        Estonia

                        1 617 491

                        Ireland

                        13 635 006

                        Greece

                        16 617 301

                        Spain

                        58 201 547

                        France

                        87 874 680

                        Italy

                        37 280 034

                        Cyprus

                        359 176

                        Latvia

                        2 689 706

                        Lithuania

                        4 577 182

                        Luxembourg

                        418 572

                        Hungary

                        15 632 995

                        Malta

                        37 135

                        Netherlands

                        8 369 372

                        Austria

                        7 194 905

                        Poland

                        26 846 892

                        Portugal

                        6 986 911

                        Romania

                        18 270 128

                        Slovenia

                        941 089

                        Slovakia

                        5 973 155

                        Finland

                        6 115 927

                        Sweden

                        8 301 611

                        United Kingdom

                        40 938 999


title: Commission Implementing Regulation (EU) 2019/1964 of 26 November 2019 concerning the authorisation of L-lysine base, liquid, L-lysine monohydrochloride, liquid, L-lysine monohydrochloride, technically pure, and L-lysine sulphate as feed additives for all animal species (Text with EEA relevance)

text:
                  28.11.2019

                  EN

                  Official Journal of the European Union

                  L 307/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1964
         of 26 November 2019
         concerning the authorisation of L-lysine base, liquid, L-lysine monohydrochloride, liquid, L-lysine monohydrochloride, technically pure, and L-lysine sulphate as feed additives for all animal species
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

                     Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 82/471/EEC (2).

                     (2)

                     Concentrated liquid L-lysine (base), concentrated liquid L-lysine monohydrochloride, L-lysine monohydrochloride, technically pure, and L-lysine sulphate produced by fermentation with Corynebacterium glutamicum were authorised without a time limit pursuant to Directive 82/471/EEC by Commission Directive 88/485/EEC (3). These feed additives were subsequently entered in the Register of feed additives as existing products, in accordance with Article 10(1) of Regulation (EC) No 1831/2003.

                     (3)

                     In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, applications were submitted for the re-evaluation of concentrated liquid L-lysine (base), concentrated liquid L-lysine monohydrochloride, L-lysine monohydrochloride, technically pure, and L-lysine sulphate produced by fermentation with Corynebacterium glutamicum as feed additives for all animal species. Applications were also submitted for the authorisation of concentrated liquid L-lysine (base), concentrated liquid L-lysine monohydrochloride, L-lysine monohydrochloride, technically pure, and L-lysine sulphate for all animal species in accordance with Article 7 of Regulation (EC) No 1831/2003. The applications were accompanied by the particulars and documents required under Article 7(3) of that Regulation.

                     (4)

                     The applications concern the authorisation of concentrated liquid L-lysine (base), concentrated liquid L-lysine monohydrochloride, L-lysine monohydrochloride, technically pure, and L-lysine sulphate as feed additives for all animal species, to be classified in the additive category ‘nutritional additives’.

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 11 September 2013 (4), 28 October 2014 (5), 10 March 2015 (6), 16 June 2015 (7), 2 December 2015 (8), 19 April 2016 (9), 28 November 2018 (10), (11) and 3 April 2019 (12) that, under the proposed conditions of use, concentrated liquid L-lysine (base) produced by Escherichia coli FERM BP-10941, Escherichia coli FERM BP-11355, Corynebacterium glutamicum KCCM 11117P, Corynebacterium glutamicum NRRL B-50547, Corynebacterium glutamicum NRRL B-50775 and Corynebacterium glutamicum KCCM 10227, concentrated liquid L-lysine monohydrochloride produced by Escherichia coli FERM BP-10941 and Escherichia coli FERM BP-11355, L-lysine monohydrochloride, technically pure, produced by Escherichia coli FERM BP-10941, Escherichia coli FERM BP-11355, Escherichia coli CGMCC 3705, Escherichia coli CGMCC 7.57, Corynebacterium glutamicum NRRL B-50547, Corynebacterium glutamicum NRRL B-50775, Corynebacterium glutamicum KCCM 11117P and Corynebacterium glutamicum KCCM 10227 and L-lysine sulphate produced by Corynebacterium glutamicum KCCM 10227 and Corynebacterium glutamicum DSM 24990 do not have an adverse effect on animal health, consumer safety or the environment. The safety of the additives produced by genetically modified microorganism, in particular by Corynebacterium glutamicum NRRL B-50547, is subject to the condition that the manufacturing process is performed ensuring that no recombinant DNA of the production strain is present in the final product. The Authority also stated that the four forms of L-lysine should be considered hazardous for the users of the additives, in particular upon inhalation. Some of the forms should also be considered to be mildly irritant to eyes or corrosive to skin and eyes. 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 additives. The Authority also concluded that the additives are an efficacious source of the amino-acid L-lysine for all animal species and that in order to be as efficacious in ruminants as in non-ruminant species, the additives should be protected against degradation in the rumen. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the methods of analysis of the feed additives in feed and water submitted by the Reference Laboratory set up by Article 21 of Regulation (EC) No 1831/2003.

                     (6)

                     The names ‘concentrated liquid L-lysine (base)’ and ‘concentrated liquid L-lysine monohydrochloride’ should be changed to ‘L-lysine base, liquid’ and ‘L-lysine monohydrochloride, liquid’ as the minimum content of L-lysine of those additives is only 50 % and 22 % respectively.

                     (7)

                     The assessment of concentrated liquid L-lysine (base), concentrated liquid L-lysine monohydrochloride, L-lysine monohydrochloride, technically pure, and L-lysine sulphate produced by fermentation with Corynebacterium glutamicum spp or Escherichia coli spp as mentioned in recital (5) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of these substances should be authorised as specified in the Annex to this Regulation.

                     (8)

                     Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for concentrated liquid L-lysine (base), concentrated liquid L-lysine monohydrochloride, L-lysine monohydrochloride, technically pure, and L-lysine sulphate produced by fermentation with Corynebacterium glutamicum, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

                     (9)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Authorisation
            The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘amino acids, their salts and analogues’, are authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.

            Article 2
            Transitional measures

               1.   Concentrated liquid L-lysine (base), concentrated liquid L-lysine monohydrochloride, L-lysine monohydrochloride, technically pure, and L-lysine sulphate produced by fermentation with Corynebacterium glutamicum authorised by Commission Directive 88/485/EEC and premixtures containing them may be placed on the market until 18 June 2020 in accordance with the rules applicable before 18 December 2019 and used until the existing stocks are exhausted.

               2.   Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 18 December 2020 in accordance with the rules applicable before 18 December 2019 may be placed on the market and used until the existing stocks are exhausted if they are intended for food producing animals.

               3.   Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 18 December 2021 in accordance with the rules applicable before 18 December 2019 may be placed on the market and used until the existing stocks are exhausted if they are intended for non-food producing animals.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 26 November 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

            (2)  Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (OJ L 213, 21.7.1982, p. 8).

            (3)  Commission Directive 88/485/EEC of 26 July 1988 amending the Annex to Council Directive 82/471/EEC concerning certain products used in animal nutrition (OJ L 239, 30.8.1988, p. 36).

            (4)  EFSA Journal 2013;11(10):3365.

            (5)  EFSA Journal 2014;12(11):3895.

            (6)  EFSA Journal 2015;13(3):4052.

            (7)  EFSA Journal 2015;13(7):4156.

            (8)  EFSA Journal 2016;14(3):4346.

            (9)  EFSA Journal 2016;14(5):4471.

            (10)  EFSA Journal 2019;17(1):5532.

            (11)  EFSA Journal 2019;17(1):5537.

            (12)  EFSA Journal 2019;17(5):5697.

            ANNEX

                        Identification number of the additive

                        Name of the holder of authorisation

                        Additive

                        Composition, chemical formula, description, analytical method.

                        Species or category of animal

                        Maximum age

                        Minimum content

                        Maximum content

                        Other provisions

                        End of period of authorisation

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

                           Category of nutritional additives. Functional group: amino acids, their salts and analogues.

                        3c320

                        -

                        L-lysine base, liquid

                           Additive composition:

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

                           Characterisation of the active substance:

                        L-lysine produced by fermentation with Escherichia coli FERM BP-10941 or

                           Escherichia coli FERM BP-11355 or

                           Corynebacterium glutamicum KCCM 11117P or

                           Corynebacterium glutamicum NRRL B-50547 or

                           Corynebacterium glutamicum NRRL B-50775 or

                           Corynebacterium glutamicum KCCM 10227.
                        Chemical formula: NH2-(CH2)4-CH(NH2)-COOH
                        CAS Number: 56-87-1

                           Analytical methods (1):

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

                                    —

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

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

                                    —

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

                              For the quantification of lysine in water:

                                    —

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

                                    —

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

                        All species

                        -

                        -

                        -

                                    1.

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

                                    2.

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

                                    3.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation and for the skin and eyes. 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 breathing, skin and eye protection.

                                    4.

                                    The additive can be also used via water for drinking.

                                    5.

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

                        18.12.2029

                        3c321

                        -

                        L-lysine monohydrochloride, liquid

                           Additive composition:

                        Aqueous solution of L-lysine monohydrochloride with a minimum of 22 % L-lysine and a maximum moisture content of 66 % (minimum of 58 % L-lysine in the dry matter).

                           Characterisation of the active substance:

                        L-lysine monohydrochloride produced by fermentation with

                           Escherichia coli FERM BP-10941 or Escherichia coli FERM BP-11355.
                        Chemical formula: NH2-(CH2)4-CH(NH2)-COOH
                        CAS Number: 657-27-2

                           Analytical methods (1):

                        For the identification of L-lysine monohydrochloride in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-lysine monohydrochloride monograph’

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

                                    —

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

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

                                    —

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

                        All species

                        -

                        -

                        -

                                    1.

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

                                    2.

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

                                    3.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation and for eyes. 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 breathing and eye protection.

                                    4.

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

                        18.12.2029

                        3c322

                        L-lysine monohydrochloride, technically pure

                           Additive composition:

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

                           Characterisation of the active substance:

                        L-lysine monohydrochloride produced by fermentation with

                           Escherichia coli FERM BP-10941 or Escherichia coli FERM BP-11355 or Escherichia coli CGMCC 3705 or Escherichia coli CGMCC 7.57 or Corynebacterium glutamicum NRRL B-50547 or

                           Corynebacterium glutamicum NRRL B-50775 or

                           Corynebacterium glutamicum KCCM 11117P or

                           Corynebacterium glutamicum KCCM 10227.
                        Chemical formula: NH2-(CH2)4-CH(NH2)-COOH
                        CAS Number: 657-27-2

                           Analytical methods (1):

                        For the identification of L-lysine monohydrochloride in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-lysine monohydrochloride monograph’

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

                                    —

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

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

                                    —

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

                              For the quantification of lysine in water:

                                    —

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

                                    —

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

                        All species

                        -

                        -

                        -

                                    1.

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

                                    2.

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

                                    3.

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

                                    4.

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

                                    5.

                                    The additive can be also used via water for drinking.

                                    6.

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

                        18.12.2029

                        3c324

                        L-lysine sulphate

                           Additive composition:

                        Granulate with a minimum L-lysine content of 52 % and a maximum content of 24 % sulphate.

                           Characterisation of the active substance:

                        L-lysine sulphate produced by fermentation with Corynebacterium glutamicum KCCM 10227 or

                           Corynebacterium glutamicum DSM 24990.
                        Chemical formula: C12H28N4O4•H2SO4/[NH2-(CH2)4-CH(NH2)-COOH]2SO4

                        CAS number: 60343-69-3

                           Analytical methods (1):

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

                                    —

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

                              For the identification of sulphate in the feed additive:

                                    —

                                    European Pharmacopoeia Monograph 20301

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

                                    —

                                    ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-UV) – Commission Regulation (EC) No 152/2009.

                        All species

                        -

                        -

                        10 000

                                    1.

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

                                    2.

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

                                    3.

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

                                    4.

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

                        18.12.2029

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

               (2)  Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2018;16(10):5458); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).


title: Commission Implementing Regulation (EU) 2019/1965 of 26 November 2019 concerning the authorisation of sodium molybdate dihydrate as feed additive for sheep (Text with EEA relevance)

text:
                  28.11.2019

                  EN

                  Official Journal of the European Union

                  L 307/12

         COMMISSION IMPLEMENTING REGULATION (EU) 2019/1965
         of 26 November 2019
         concerning the authorisation of sodium molybdate dihydrate as feed additive for sheep
         (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)

                     Sodium molybdate was authorised without a time limit as a feed additive for all animal species in accordance with Directive 70/524/EEC. This substance 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 sodium molybdate dihydrate as a feed additive for sheep.

                     (4)

                     The applicant requested sodium molybdate dihydrate to be classified in the additive category ‘nutritional additives’. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

                     (5)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 23 January 2019 (3) that, under the proposed conditions of use, sodium molybdate dihydrate does not have adverse effects on animal health, consumer safety or the environment. It also concluded that the additive is considered as a skin and eye 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. Moreover, the Authority concluded that molybdenum supplementation in sheep feed with sodium molybdate dihydrate is considered effective in order to guarantee an adequate balance with copper, when the copper to molybdenum ratio in the diet is in the range 3-10. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the reports on the method of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Article 21 of Regulation (EC) No 1831/2003.

                     (6)

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

                     (7)

                     Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for the substance sodium molybdate dihydrate, 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
            Authorisation
            The substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is authorised as feed additive in animal nutrition, subject to the conditions laid down in that Annex.

            Article 2
            Transitional measures

               1.   Sodium molybdate dihydrate and premixtures containing that substance, which are produced and labelled before 18 June 2020 in accordance with the rules applicable before 18 December 2019 may continue to be placed on the market and used until the existing stocks are exhausted.

               2.   Feed materials and compound feed containing sodium molybdate dihydrate which are produced and labelled before 18 December 2020 in accordance with the rules applicable before 18 December 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

               3.   Feed materials and compound feed containing sodium molybdate dihydrate which are produced and labelled before 18 December 2021 in accordance with the rules applicable before 18 December 2019 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food-producing animals.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 26 November 2019.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

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

            (3)  EFSA Journal 2019;17(2):5606.

            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

                        Content of element (Mo) in mg/kg of complete feed with a moisture content of 12 %

                           Category of nutritional additives. Functional group: compounds of trace elements

                        3b701

                        -

                        Sodium molybdate dihydrate

                           Additive composition:

                        Sodium molybdate dihydrate as a powder with a minimum content of 37 % molybdenum.

                           Characterisation of the active substance:

                        Chemical formula: Na2MoO4. 2 H2O
                        CAS number: 10102-40-6

                           Analytical methods
                            (1):
                        For the quantification of total molybdenum in the feed additive, premixtures, feed materials and compound feed:

                                    —

                                    EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP- AES)

                              For the quantification of total sodium in the feed additive:

                                    —

                                    EN 15510: Inductively Coupled Plasma — Atomic Emission Spectrometry (ICP- AES); or

                                    —

                                    EN ISO 6869: Atomic Absorption Spectrometry (AAS)

                        Sheep

                        -

                        -

                        2,5 (total)

                                    1.

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

                                    2.

                                    For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by dermal or eyes contact. Where risks cannot be reduced to an acceptable level by those procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment.

                                    3.

                                    The labelling of the additive and premixtures shall indicate the following:
                                    ‘Molybdenum supplementation in sheep feed shall result in a Cu:Mo ratio in the diet in the range of 3-10, in order to guarantee an adequate balance with copper’.

                        18.12.2029

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