title: Commission Implementing Regulation (EU) 2021/1179 of 16 July 2021 amending Implementing Regulation (EU) No 1051/2011 as regards the aggregate tables and micro-data files for the transmission of the data (Text with EEA relevance)

text:
                  19.7.2021

                  EN

                  Official Journal of the European Union

                  L 256/89

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1179
         of 16 July 2021
         amending Implementing Regulation (EU) No 1051/2011 as regards the aggregate tables and micro-data files for the transmission of the data
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 692/2011 of the European Parliament and of the Council of 6 July 2011 concerning European statistics on tourism and repealing Council Directive 95/57/EC (1), and in particular Article 9(2) and (3) thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) No 1051/2011 (2) lays down the exchange standard for aggregate tables and micro-data files.

                     (2)

                     Following the entry into force of Commission Delegated Regulation (EU) 2019/1681 (3) laying down technical changes to the transmission format for annual data to be transmitted to the Commission, it is necessary to adapt Annexes II and III to Implementing Regulation (EU) No 1051/2011 as regards the aggregate tables and micro-data files for transmission of data.

                     (3)

                     Implementing Regulation (EU) No 1051/2011 should therefore be amended accordingly.

                     (4)

                     The measures provided for in this Regulation are in accordance with the opinion of the European Statistical System Committee, established by Article 7 of Regulation (EC) No 223/2009 of the European Parliament and of the Council (4),

               HAS ADOPTED THIS REGULATION:

            Article 1
            Implementing Regulation (EU) No 1051/2011 is amended as follows:

                        (1)

                        Annex II is amended as follows:
                        under ‘Header’, the datasets listed in the third indent are amended as follows:

                                    (1)

                                    ‘int_cap_annual’ is replaced by ‘TOUR_CAP_A’;

                                    (2)

                                    ‘int_occ_annual’ is replaced by ‘TOUR_OCC_A’;

                                    (3)

                                    ‘int_occ_mnight’ is replaced by ‘TOUR_NIGHTS_M’;

                                    (4)

                                    ‘int_occ_marrno’ is replaced by ‘TOUR_ARRNOCC_M’;

                                    (5)

                                    ‘int_non_rented’ is replaced by ‘TOUR_NONRENT_A’;

                                    (6)

                                    ‘nat_dem_partic’ is replaced by ‘TOUR_PARTIC_A’;

                                    (7)

                                    ‘nat_dem_sdvout’ is replaced by ‘TOUR_SDVOUT_Q’;

                                    (8)

                                    ‘nat_dem_sdvdom’ is replaced by ‘TOUR_SDVDOM_Q’;

                        (2)

                        Annex III is replaced by the text in the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 16 July 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 192, 22.7.2011, p. 17.

            (2)  Commission Implementing Regulation (EU) No 1051/2011 of 20 October 2011 implementing Regulation (EU) No 692/2011 of the European Parliament and of the Council concerning European statistics on tourism, as regards the structure of the quality reports and the transmission of the data (OJ L 276, 21.10.2011, p. 13).

            (3)  Commission Delegated Regulation (EU) 2019/1681 of 1 August 2019 amending Regulation (EU) No 692/2011 of the European Parliament and of the Council concerning European statistics on tourism, as regards the transmission deadlines and adaptation of Annexes I and II (OJ L 258, 9.10.2019, p. 1).

            (4)  Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164).

            ANNEX

                     ‘ANNEX III

                        Micro-data files for the transmission of data listed in Section 2 of Annex II to Regulation (EU) No 692/2011

                        File structure and codification: practical arrangements

                     Each observed trip shall be an individual record in the transmitted micro-data file. This micro-data file shall be fully checked, edited and, where necessary, imputed, and shall follow the file structure and codification described in the table below. The Commission (Eurostat) will supply additional guidance on the format for transmission.
                     Data that does not respect the exchange standard set out in this Annex will be considered as not having been sent.

                        Header

                     The purpose of the header is to identify the transmitted data series. It shall consist of four fields:

                                 —

                                    Reference period shall consist of seven characters, the first four identifying the year and the last three the period within the year (A00).

                                 —

                                    Country code shall consist of two characters, containing the two-character country code of the Member State transmitting the data. Examples: BE (Belgium), BG (Bulgaria), …

                                 —

                                    Subject shall consist of the identifier of the dataset: nat_dem_microdata.

                                 —

                                    Currency identifies the currency in which expenditure is reported (EUR or NAC). While euro area Member States shall provide data in euro (code EUR), non-euro area Member States can report data either in euro or in their national currency (code NAC). However, all expenditure must be reported in the same currency inside one file.

                        Data

                                 Column name

                                 Identifier

                                 Description

                                 Filter/remarks

                                 ID

                                 000001-999999

                                    Sequence number of the trip

                                    CHARACTERISTICS OF THE TRIP

                                 Field 1

                                    Month of departure

                                 01-24

                                 Number of the month (January of the reference year = 01, December of the reference year = 12; January of the previous calendar year = 13, December of the previous calendar year = 24)

                                 Field 2

                                    Duration of the trip in number of nights

                                 001-366

                                 Number of nights (3 digits maximum)

                                 Field 3

                                    Duration of the trip: number of nights spent on the domestic territory

                                 Only for outbound trips
                                 Triennial variable, in the optional years: code = Blank

                                 000-183

                                 Number of nights (3 digits maximum)

                                 Field 4

                                    Main country of destination

                                 Coding according to the country list in the methodological manual drawn up under Article 10 of Regulation (EU) No 692/2011

                                 Field 5

                                    Main purpose of the trip

                                 1

                                 Private/personal purpose: leisure, recreation and holidays

                                 2

                                 Private/personal purpose: visiting relatives and friends

                                 3

                                 Private/personal purpose: other (e.g. health treatment, pilgrimage)

                                 4

                                 Professional/business purpose

                                    Type of destination

                                 Triennial variable, in the optional years: code = Blank

                                 Field 6

                                 1

                                 City = Yes

                                 2

                                 City = No

                                 9

                                 City = Not applicable (Field 5 = 4)

                                 Field 7

                                 1

                                 Seaside = Yes

                                 2

                                 Seaside = No

                                 9

                                 Seaside = Not applicable (Field 5 = 4)

                                 Field 8

                                 1

                                 Countryside (including lakeside, riverside, etc.) = Yes

                                 2

                                 Countryside (including lakeside, riverside, etc.) = No

                                 9

                                 Countryside (including lakeside, riverside, etc.) = Not applicable (Field 5 = 4)

                                 Field 9

                                 1

                                 Cruise ship = Yes

                                 2

                                 Cruise ship = No

                                 9

                                 Cruise ship = Not applicable (Field 5 = 4)

                                 Field 10

                                 1

                                 Mountains (highlands, hills, etc.) = Yes

                                 2

                                 Mountains (highlands, hills, etc.) = No

                                 9

                                 Mountains (highlands, hills, etc.) = Not applicable (Field 5 = 4)

                                 Field 11

                                 1

                                 Other = Yes

                                 2

                                 Other = No

                                 9

                                 Other = Not applicable (Field 5 = 4)

                                 Field 12

                                    Participation of children

                                 Triennial variable, in the optional years: code = Blank

                                 1

                                 Yes

                                 2

                                 No

                                 9

                                 Not applicable (Field 5 = 4)

                                 Field 13

                                    Main means of transport

                                 1

                                 Air (flights, scheduled or chartered, or other air services)

                                 2

                                 Waterway (passenger lines and ferries, cruises, pleasure boat, rented vessel, etc.)

                                 3

                                 Railway

                                 4

                                 Bus, coach (regular/scheduled or occasional/non-scheduled)

                                 5

                                 Regular/scheduled bus or coach

                                 Optional breakdown

                                 6

                                 Occasional/non-scheduled bus or coach

                                 Optional breakdown

                                 7

                                 Private motor vehicle (owned or leased, including friends/relatives’ car)

                                 8

                                 Rented motor vehicle (including ride-sharing or car-sharing platforms)

                                 9

                                 Other (e.g. bicycle)

                                 Field 14

                                    Main means of accommodation

                                 1

                                 Rented accommodation: hotels or similar establishments

                                 2

                                 Rented accommodation: campsites, caravan or trailer park (non-residential)

                                 3

                                 Rented accommodation: such as a house, villa or apartment; rented room(s) in a dwelling

                                 4

                                 Rented accommodation: other rented accommodation (such as youth hostels, marinas, health establishments)

                                 5

                                 Non-rented accommodation: own holiday home

                                 6

                                 Non-rented accommodation: accommodation provided free of charge by relatives or friends

                                 7

                                 Non-rented accommodation: other non-rented accommodation

                                 Field 15

                                    Booking of the trip: internet booking of the main means of accommodation

                                 Triennial variable, in the optional years: code = Blank

                                 1

                                 Yes

                                 2

                                 No

                                 Field 16

                                    Booking of the trip: booking channel for the main means of accommodation

                                 Triennial variable, in the optional years: code = Blank

                                 1

                                 Directly with the accommodation provider

                                 2

                                 Via a travel agency, tour operator, portal or short-term property or holiday letting agency listing multiple accommodation providers

                                 3

                                 No booking was needed

                                 Field 17

                                    Booking of the main means of accommodation via a website or app such as Airbnb, Booking.com, Expedia, HomeAway

                                 Triennial variable, in the optional years: code = Blank

                                 1

                                 Yes

                                 2

                                 No

                                 9

                                 Not applicable (Field 14 ≠ 3 or Field 15 ≠ 1 or Field 16 ≠ 2)

                                 Field 18

                                    Booking of the trip: internet booking of the main means of transport

                                 Triennial variable, in the optional years: code = Blank

                                 1

                                 Yes

                                 2

                                 No

                                 Field 19

                                    Booking of the trip: booking channel for the main means of transport

                                 Triennial variable, in the optional years: code = Blank

                                 1

                                 Directly with the transport provider

                                 2

                                 Via a travel agency, tour operator, portal

                                 3

                                 No booking was needed

                                 Field 20

                                    Booking of the main means of transport via a website or app such as BlaBlaCar

                                 Optional triennial variable, if not transmitted: code = Blank

                                 1

                                 Yes

                                 2

                                 No

                                 9

                                 Not applicable (Field 18 ≠ 1 or Field 19 ≠ 2)

                                 Field 21

                                    Booking of the trip: package trip

                                 Triennial variable, in the optional years: code = Blank

                                 1

                                 Yes

                                 2

                                 No

                                 Field 22

                                    Booking of the trip: internet booking of the package

                                 Triennial variable, in the optional years: code = Blank

                                 1

                                 Yes

                                 2

                                 No

                                 Field 23

                                    Expenditure related to the trip by the individual tourist on packages

                                 00000000-99999998

                                 Amount in euro (or in national currency for non-euro area Member States) (8 digits maximum)

                                 Field 24

                                    Expenditure related to the trip by the individual tourist on transport

                                 00000000-99999998

                                 Amount in euro (or in national currency for non-euro area Member States) (8 digits maximum)

                                 Field 25

                                    Expenditure related to the trip by the individual tourist on accommodation

                                 00000000-99999998

                                 Amount in euro (or in national currency for non-euro area Member States) (8 digits maximum)

                                 Field 26

                                    Expenditure related to the trip by the individual tourist on food and drinks in cafés and restaurants

                                 Optional variable, if not transmitted: code = Blank

                                 00000000-99999998

                                 Amount in euro (or in national currency for non-euro area Member States) (8 digits maximum)

                                 Field 27

                                    Other expenditure related to the trip by the individual tourist (total other, including durables and valuable goods)

                                 00000000-99999998

                                 Amount in euro (or in national currency for non-euro area Member States) (8 digits maximum)

                                 Field 28

                                    Durables and valuable goods (subcategory of “Other expenditure related to the trip by the individual tourist”)

                                 00000000-99999998

                                 Amount in euro (or in national currency for non-euro area Member States) (8 digits maximum)

                                    Profile of the visitor

                                 Field 29

                                    Gender

                                 1

                                 Male

                                 2

                                 Female

                                 Field 30

                                    Age

                                 000-198

                                 Number of full years (3 digits)

                                 Field 31

                                    Country of residence

                                 The two-digit country code (Belgium = BE, Bulgaria = BG, ...)

                                 Field 32

                                    Educational attainment level

                                 Optional variable, if not transmitted: code = Blank

                                 1

                                 At most lower secondary (ISCED 2011 levels 0-2)

                                 2

                                 Upper secondary and post-secondary (non-tertiary) (ISCED 2011 levels 3 and 4)

                                 3

                                 Tertiary (ISCED 2011 levels 5-8)

                                 Field 33

                                    Employment situation

                                 Optional variable, if not transmitted: code = Blank

                                 1

                                 Employed (employee or self-employed)

                                 2

                                 Unemployed

                                 3

                                 Student (or pupil)

                                 4

                                 Other not in the labour force

                                 Field 34

                                    Household income in quartiles

                                 Optional variable, if not transmitted: code = Blank’

                                 1

                                 1st quartile

                                 2

                                 2nd quartile

                                 3

                                 3rd quartile

                                 4

                                 4th quartile

                                    Grossing-Up factor

                                    Grossing-up factor from sample to population

                                 Field 35

                                 000000-999999

                                 Field 35 contains integers

                                 Field 36

                                 000-999

                                 Field 36 contains decimal places


title: Commission Implementing Regulation (EU) 2021/1264 of 26 July 2021 approving amendments to the specification for a Protected Designation of Origin or a Protected Geographical Indication (‘Coteaux du Libron’ (PGI))

text:
                  2.8.2021

                  EN

                  Official Journal of the European Union

                  L 277/31

         COMMISSION IMPLEMENTING REGULATION (EU) 2021/1264
         of 26 July 2021
         approving amendments to the specification for a Protected Designation of Origin or a Protected Geographical Indication (‘Coteaux du Libron’ (PGI))
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Commission Delegated Regulation (EU) 2019/33 of 17 October 2018 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards applications for protection of designations of origin, geographical indications and traditional terms in the wine sector, the objection procedure, restrictions of use, amendments to product specifications, cancellation of protection, and labelling and presentation (1), and in particular Article 15(2) thereof,
         Whereas:

                     (1)

                     The Commission examined France’s application for the approval of amendments to the specification for the Protected Geographical Indication ‘Coteaux du Libron’, submitted pursuant to Article 105 of Regulation (EU) No 1308/2013. These amendments include changing the name ‘Coteaux du Libron’ to ‘Coteaux de Béziers’.

                     (2)

                     The Commission published the application for the approval of amendments to the specification in the Official Journal of the European Union (2), as required by Article 97(3) of Regulation (EU) No 1308/2013.

                     (3)

                     No statement of objection has been received by the Commission under Article 98 of Regulation (EU) No 1308/2013.

                     (4)

                     The amendments to the specification should therefore be approved in accordance with Article 99 of Regulation (EU) No 1308/2013 in conjunction with Article 15(2) of Delegated Regulation (EU) 2019/33.

                     (5)

                     The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of Agricultural Markets,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Coteaux du Libron’ (PGI) 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, 26 July 2021.

                  For the Commission

                  On behalf of the President

               Janusz WOJCIECHOWSKI

                  Member of the Commission

            (1)  OJ L 9, 11.1.2019, p. 2.

            (2)  OJ C 412, 30.11.2020, p. 18.


title: Commission Implementing Regulation (EU) 2022/698 of 3 May 2022 renewing the approval of the active substance bifenazate 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:
                  4.5.2022

                  EN

                  Official Journal of the European Union

                  L 130/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2022/698
         of 3 May 2022
         renewing the approval of the active substance bifenazate 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)(a) thereof,
         Whereas:

                     (1)

                     Commission Directive 2005/58/EC (2) included bifenazate 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 bifenazate, as set out in Part A of the Annex to Implementing Regulation (EU) No 540/2011 expires on 31 July 2022.

                     (4)

                     An application for the renewal of the approval of the active substance bifenazate was submitted to the Rapporteur Member State 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 draft 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 29 January 2016.

                     (7)

                     The Authority made the supplementary summary dossier available to the public. The Authority also circulated the draft renewal assessment report to the applicant and to the Member States for comments and launched a public consultation on it. The Authority forwarded the comments received to the Commission.

                     (8)

                     On 4 January 2017, the Authority communicated to the Commission its conclusion (6) on whether bifenazate can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009, where EFSA identified high risk to birds, mammals and non-target arthropods for all representative uses and in addition, a high risk to operators and workers for a majority of the representative uses. Furthermore, the risk assessment could not be finalised for aquatic organisms and consumers.

                     (9)

                     The Commission mandated EFSA in 17 November 2020 to assess the risk when bifenazate is applied once a year using the lowest dose presented in the dossier. The rapporteur Member State updated its draft Renewal Assessment Report accordingly and the Authority updated its conclusion on 30 August 2021 (7) in which it identified a high risk to birds via long term exposure to bifenazate for all representative uses. Furhtermore, the consumer risk assessment could not be finalised. The Commission presented a renewal report regarding bifenazate to the Standing Committee on Plants, Animals, Food and Feed on 19 July 2017 and 22 October 2021 and a draft of this Regulation on 1 December 2021.

                     (10)

                     The Commission invited the applicant to submit its comments on both conclusions of the Authority and, in accordance with the third paragraph of Article 14(1) of Implementing Regulation (EU) No 844/2012 (8), on the renewal report. The applicant submitted its comments, which have been carefully examined.

                     (11)

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

                     (12)

                     It is therefore appropriate to renew the approval of bifenazate.

                     (13)

                     In accordance with Article 14(1) of Regulation (EC) No 1107/2009 in conjunction with Article 6 thereof and in the light of current scientific and technical knowledge, it is, however, necessary to provide for certain conditions and restrictions. It is, in particular, appropriate to restrict the use of plant protection products containing bifenazate to non-edible crops in permanent greenhouses and to require further confirmatory information.

                     (14)

                     The restriction to use on non-edible crops will exclude dietary exposure of consumers and is required since the consumer risk assessment could not be finalised. As a high risk was identified to birds via long term exposure to bifenazate, a restriction to use in greenhouses as defined in Article 3 of Regulation (EC) No 1107/2009 will ensure that birds are not exposed to bifenazate. In addition, as the Authority identified a high risk to mammals for some representative uses and a high chronic risk to bees based on the available data, the restriction to use only in greenhouses will also prevent exposure to those non-target organisms as well as in drinking water.

                     (15)

                     As regards the criteria to identify endocrine disrupting properties introduced by Commission Regulation (EU) 2018/605 (9), on the basis of the available scientific information summarised in the conclusion of the Authority, the Commission considers that bifenazate is not to be considered as having endocrine disrupting properties.

                     (16)

                     In order to increase the confidence in the conclusion that bifenazate does not have endocrine disrupting properties, the applicant should provide an updated assessment, in accordance with point 2.2(b) of Annex II to Regulation (EC) No 1107/2009, of the criteria laid down in points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, and in accordance with the guidance for the identification of endocrine disruptors (10).

                     (17)

                     The risk assessment for the renewal of the approval of the active substance bifenazate is based on representative uses as an acaricide. In the light of this risk assessment, it is not necessary to maintain the restriction to use only as an acaricide.

                     (18)

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

                     (19)

                     Commission Implementing Regulation (EU) 2021/745 (11) extended the approval period of bifenazate to 31 July 2022 in order to allow the renewal process to be completed before the expiry of the approval period of that active substance. However, given that a decision on renewal has been taken ahead of that extended expiry date, this Regulation shall apply as soon as possible.

                     (20)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Renewal of the approval of the active substance
            The approval of the active substance bifenazate, as specified in Annex I, is renewed subject to the conditions and restrictions laid down in that Annex.

            Article 2
            Amendments to Implementing Regulation (EU) No 540/2011
            The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.

            Article 3
            Entry into force and date of application
            This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
            It shall apply from 1 July 2022.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 3 May 2022.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Directive 2005/58/EC of 21 September 2005 amending Council Directive 91/414/EEC to include bifenazate and milbemectin as active substances (OJ L 246, 22.9.2005, p. 17).

            (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 Journal 2017;15(1):4693. Available online: www.efsa.europa.eu.

            (7)  EFSA Updated peer review of the pesticide risk assessment of the active substance bifenazate EFSA Journal 2021;19(8):6818.

            (8)  Implementing Regulation (EU) No 844/2012 was replaced by Implementing Regulation (EU) 2020/1740 (OJ L 392, 23.11.2020, p. 20). However, it shall continue to apply to the procedure for the renewal of the approval of the active substances: (1) whose approval period ends before 27 March 2024; (2) for which a Regulation, adopted in accordance with Article 17 of Regulation (EC) No 1107/2009 on or after 27 March 2021, extends the approval period to 27 March 2024 or a later date.

            (9)  Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties (OJ L 101, 20.4.2018, p. 33).

            (10)  ECHA (European Chemicals Agency) and EFSA (European Food Safety Authority) with the technical support of the Joint Research Centre (JRC), Andersson N, Arena M, Auteri D, Barmaz S, Grignard E, Kienzler A, Lepper P, Lostia AM, Munn S, Parra Morte JM, Pellizzato F, Tarazona J, Terron A and Van der Linden S, 2018. Guidance for the identiﬁcation of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. EFSA Journal 2018;16(6):5311.135 pp.

            (11)  Commission Implementing Regulation (EU) 2021/745 of 6 May 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances aluminium ammonium sulphate, aluminium silicate, beflubutamid, benthiavalicarb, bifenazate, boscalid, calcium carbonate, captan, carbon dioxide, cymoxanil, dimethomorph, ethephon, extract from tea tree, famoxadone, fat distilation residues, fatty acids C7 to C20, flumioxazine, fluoxastrobin, flurochloridone, folpet, formetanate, gibberellic acid, gibberellins, heptamaloxyloglucan, hydrolysed proteins, iron sulphate, metazachlor, metribuzin, milbemectin, Paecilomyces lilacinus strain 251, phenmedipham, phosmet, pirimiphos-methyl, plant oils/rape seed oil, potassium hydrogen carbonate, propamocarb, prothioconazole, quartz sand, fish oil, repellents by smell of animal or plant origin/ sheep fat, S-metolachlor, Straight Chain Lepidopteran Pheromones, tebuconazole and urea (OJ L 160, 7.5.2021, p. 89).

            ANNEX I

                        Common Name, Identification Numbers

                        IUPAC Name

                        Purity (1)

                        Date of approval

                        Expiration of approval

                        Specific provisions

                        Bifenazate
                        149877-41-8
                        736

                        isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate

                        980 g/kg
                        Toluene is of toxicological concern and must not exceed 0,7 g/kg in the technical material.

                        1 July 2022

                        30 June 2037

                        Only uses on non-edible crops in permanent greenhouses shall be authorised.
                        For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on bifenazate, and in particular Appendices I and II thereof, shall be taken into account.
                        In this overall assessment Member States shall pay particular attention to:

                                    —

                                    the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment;

                                    —

                                    the risk to bees and bumble bees released for pollination in permanent greenhouses.

                              Conditions of use shall include risk mitigation measures, where appropriate.
                        The applicant shall submit by 24 May 2024 to the Commission, the Member States and the Authority confirmatory information as regards points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605, in particular an updated assessment of the information submitted previously and, where relevant, further information to confirm the absence of endocrine activity.

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

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

                        (1)

                        in Part A, entry 109 on bifenazate is deleted;

                        (2)

                        in Part B, the following entry is added:

                                    No.

                                    Common Name, Identification Numbers

                                    IUPAC Name

                                    Purity (1)

                                    Date of approval

                                    Expiration of approval

                                    Specific provisions

                                    ‘152

                                    Bifenazate
                                    149877-41-8
                                    736

                                    isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinoformate

                                    980 g/kg
                                    Toluene is of toxicological concern and must not exceed 0,7 g/kg in the technical material.

                                    1 July 2022

                                    30 June 2037

                                    Only uses on non-edible crops in permanent greenhouses shall be authorised.
                                    For the implementation of the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the renewal report on bifenazate, and in particular Appendices I and II thereof, shall be taken into account.
                                    In this overall assessment Member States shall pay particular attention to:

                                                —

                                                the protection of operators and workers, ensuring that conditions of use include the application of adequate personal protective equipment;

                                                —

                                                the risk to bees and bumble bees released for pollination in permanent greenhouses.

                                          Conditions of use shall include risk mitigation measures, where appropriate.
                                    The applicant shall submit by 24 May 2024 to the Commission, the Member States and the Authority confirmatory information as regards points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Regulation (EU) 2018/605, in particular an updated assessment of the information submitted previously and, where relevant, further information to confirm the absence of endocrine activity.’

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


title: Commission Implementing Regulation (EU) 2020/665 of 13 May 2020 entering a name in the register of protected designations of origin and protected geographical indications (‘Aceite de Jaén’ (PGI))

text:
                  19.5.2020

                  EN

                  Official Journal of the European Union

                  L 156/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/665
         of 13 May 2020
         entering a name in the register of protected designations of origin and protected geographical indications (‘Aceite de Jaén’ (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, Spain’s application to register the name ‘Aceite de Jaén’ 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 ‘Aceite de Jaén’ should therefore be entered in the register,

               HAS ADOPTED THIS REGULATION:

            Article 1
            The name ‘Aceite de Jaén’ (PGI) is hereby entered in the register.
            The name specified in the first paragraph denotes a product in Class 1.5. Oils and fats (butter, margarine, oil, etc.), as listed 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, 13 May 2020.

                  For the Commission,

                  On behalf of the President,

               Janusz WOJCIECHOWSKI

                  Member of the Commission

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

            (2)  OJ C 30, 29.1.2020, p. 9.

            (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) 2020/1090 of 24 July 2020 concerning the authorisation of L-histidine monohydrochloride monohydrate as a feed additive for all animal species (Text with EEA relevance)

text:
                  27.7.2020

                  EN

                  Official Journal of the European Union

                  L 241/1

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1090
         of 24 July 2020
         concerning the authorisation of L-histidine monohydrochloride monohydrate 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 three applications were submitted for the authorisation of L-histidine monohydrochloride monohydrate. The applications were accompanied by the particulars and documents required under Article 7(3) of that Regulation.

                     (3)

                     The applications concern the authorisation of L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526, Corynebacterium glutamicum KCCM 80172 or Corynebacterium glutamicum KCCM 80179 as a feed additive for all animal species, to be classified in the additive category ‘nutritional additives’. L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526 and Corynebacterium glutamicum KCCM 80179 are also applied for the additive category ‘sensory additives’.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinions of 2 July 2019 (2)
                        , (3)
                        , (4) that, under the proposed conditions of use, L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526, Corynebacterium glutamicum KCCM 80172 or Corynebacterium glutamicum KCCM 80179, when supplemented at levels appropriate to the requirements of the target species, does not have an adverse effect on animal health, consumer safety or the environment. This conclusion covers also the use of L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526 or Corynebacterium glutamicum KCCM 80179 as sensory additive at the intended use level. With respect to the safety of the user of the additive, the Authority stated only a mild irritation risk to the eyes for L-histidine monohydrochloride monohydrate produced by Corynebacterium glutamicum KCCM 80172 or Corynebacterium glutamicum KCCM 80179. For L-histidine monohydrochloride monohydrate produced by fermentation with Escherichia coli NITE BP-02526, the Authority stated a risk by inhalation. Therefore, appropriate protective measures should be taken for this additive to prevent adverse effects on human health, in particular as regards the users of the additive. Further, the Authority concluded that L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526, Corynebacterium glutamicum KCCM 80172 or Corynebacterium glutamicum KCCM 80179 is an efficacious source of the essential amino acid L-histidine for animal nutrition and that in order to be efficacious in ruminants, the additive should be protected against degradation in the rumen. Moreover, the Authority concluded that L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526 or Corynebacterium glutamicum KCCM 80179 is efficacious as feed flavouring compound.

                     (5)

                     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.

                     (6)

                     Restrictions and conditions should be provided for to allow for a better control for those additives when used as flavourings. For these additives used as flavourings recommended contents should be indicated on the label. Where such contents are exceeded, certain information should be indicated on the label of premixtures. The use of L-histidine monohydrochloride monohydrate as a flavouring compound is not authorised in water for drinking. The fact that L-histidine monohydrochloride monohydrate is not authorised for use as a flavouring in water for drinking, does not preclude its use in compound feed, which is administered via water.

                     (7)

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

                     (8)

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

               HAS ADOPTED THIS REGULATION:

            Article 1

               1.   L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526, Corynebacterium glutamicum KCCM 80172 or Corynebacterium glutamicum KCCM 80179 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 feed additives in animal nutrition subject to the conditions laid down in that Annex.

               2.   L-histidine monohydrochloride monohydrate produced by Escherichia coli NITE BP-02526 or Corynebacterium glutamicum KCCM 80179 specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’ is authorised as a feed 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, 24 July 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2019; 17(7):5783.

            (3)  EFSA Journal 2019; 17(7):5784.

            (4)  EFSA Journal 2019; 17(8):5785.

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

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

                        3c352

                        -

                        L-histidine monohydrochloride monohydrate

                           Additive composition:

                        Powder with a minimum content of
                        98 % L-histidine monohydrochloride monohydrate and
                        72 % histidine and
                        a maximum content of 100 ppm histamine

                        All animal species

                        -

                        -

                        -

                                    1.

                                    L-histidine monohydrochloride monohydrate may be placed on the market and used as an additive consisting of a preparation.

                                    2.

                                    The additive can be also used via water for drinking.

                                    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 premixture, feed business operators shall establish operational procedures and organisational measures to address potential risks for the eyes and skin and by inhalation. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixture shall be used with personal protective equipment.

                                    5.

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

                                    6.

                                    Declaration to be made on the label of the additive and premixture:
                                    ‘The supplementation with L-histidine monohydrochloride monohydrate, in particular via water for drinking, should take into account all essential and conditional essential amino acids in order to avoid imbalances.’

                                                —

                                                Histidine content.

                        16.8.2030

                           Characterisation of the active substance:

                        L-histidine monohydrochloride monohydrate produced by fermentation with Corynebacterium glutamicum KCCM 80172 or

                           Corynebacterium glutamicum KCCM 80179 or

                           Escherichia coli NITE BP-02526
                        Chemical formula: C3H3N2-CH2-CH(NH2)-COΟΗ· HCl· H2O
                        CAS number: 5934-29-2

                           Analytical method
                            (1):
                        For the quantification of histidine in the feed additive:

                                    —

                                    high performance liquid chromatography coupled with photometric detection (HPLC-UV)

                                    —

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

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

                                    —

                                    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 histidine in water:

                                    —

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

                           Category: Sensory additives. Functional group: Flavouring compounds

                        3c352

                        -

                        L-histidine monohydrochloride monohydrate

                           Additive composition:

                        Powder with a minimum content of
                        98 % L-histidine monohydrochloride monohydrate and
                        72 % histidine and
                        a maximum content of 100 ppm histamine

                        All animal species

                        -

                        -

                        -

                                    1.

                                    L-histidine monohydrochloride monohydrate may be placed on the market and used as an additive consisting of a preparation.

                                    2.

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

                                    3.

                                    The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1 600  IU endotoxins/m3 air (3).

                                    4.

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

                                    5.

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

                                    6.

                                    On the label of the additive the following shall be indicated:
                                    ‘Recommended maximum content of the active substance of complete feedingstuff with a moisture content of 12 %: 25 mg/kg ‘

                                                —

                                                The histidine content.

                                    7.

                                    The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixtures, if the following content of the active substance in complete feedingstuff with a moisture content of 12 % is exceeded: 25 mg/kg.

                        16.8.2030

                           Characterisation of the active substance:

                        L-histidine monohydrochloride monohydrate produced by fermentation with Corynebacterium glutamicum KCCM 80179 or

                           Escherichia coli NITE BP-02526.
                        Chemical formula: C3H3N2-CH2-CH(NH2-COΟΗ· HCl· H2O
                        CAS number: 5934-29-2

                           Analytical method
                            (1):
                        For the quantification of histidine in the feed additive:

                                    —

                                    high performance liquid chromatography coupled with photometric detection (HPLC-UV)

                                    —

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

                              For the quantification of histidine in premixtures:

                                    —

                                    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), Commission Regulation (EC) No 152/2009 (Annex III, F)

                              For the quantification of histidine in feed materials and compound feed:

                                    —

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

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

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

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


title: Commission Implementing Regulation (EU) 2020/1091 of 24 July 2020 concerning the authorisation of L-threonine as a feed additive for all animal species (Text with EEA relevance)

text:
                  27.7.2020

                  EN

                  Official Journal of the European Union

                  L 241/6

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1091
         of 24 July 2020
         concerning the authorisation of L-threonine 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 L-threonine produced by Escherichia coli CGMCC 11473 as a feed additive for use in feed for all animal species. The application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.

                     (3)

                     This application concerns the authorisation of L-threonine produced by Escherichia coli CGMCC 11473 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 opinion of 5 July 2017 (2) combined with the opinion of 4 October 2019 (3) that, under the proposed conditions of use, L-threonine produced by Escherichia coli CGMCC 11473 does not have an adverse effect on animal health, consumer health or the environment. It also could not conclude on the potential of L-threonine produced by Escherichia coli CGMCC 11473 to be a skin sensitiser and irritant to the skin and eyes, and stated an inhalation risk to endotoxins for the users of the additive. Therefore, appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that the additive is an efficacious source of the amino acid L-threonine for all animal species and that in order to be as efficacious in ruminants as in non-ruminant species, the additive 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 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 L-threonine produced by Escherichia coli CGMCC 11473 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of this additive should be authorised as specified in the Annex to this Regulation.

                     (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 ‘amino acids, their salts and analogues’, 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, 24 July 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  EFSA Journal 2017;15(7):4939.

            (3)  EFSA Journal 2019;17(11):5885.

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

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

                        3c411

                        -

                        L-threonine

                           Additive composition:

                        Powder with a minimum of 98 % L-threonine and a maximum moisture content of 1 %

                        All species

                        -

                        -

                        -

                                    1.

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

                                    2.

                                    L-threonine may be used via water for drinking.

                                    3.

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

                                    4.

                                    The endotoxin content of the additive and its dusting potential shall ensure a maximal endotoxin exposure of 1600 IU endotoxins/m3 air (2).

                                    5.

                                    The labelling of the additive and premixtures shall indicate the following:
                                    ‘The supplementation with L-threonine, in particular via water for drinking, should take into account all essential and conditional essential amino acids in order to avoid imbalances.’

                        16.8.2030

                           Characterisation of the active substance:

                        L-threonine produced by fermentation with Escherichia coli CGMCC 11473
                        Chemical formula: C4H9NO3

                        CAS Number: 72-19-5.

                           Analytical methods
                            (1):
                        For the determination of L-threonine in the feed additive:

                                    —

                                    Food Chemical Codex ‘L-threonine monograph’ and

                                    —

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

                              For the determination of threonine in premixtures:

                                    —

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

                                    —

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

                              For the determination of threonine in 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 determination of threonine in water:

                                    —

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

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

               (2)  Exposure calculated based on the endotoxin level and the dusting potential of the additive according to the method used by EFSA (EFSA Journal 2017;15(7):4939); analytical method: European Pharmacopoeia 2.6.14. (bacterial endotoxins).


title: Commission Implementing Regulation (EU) 2020/1092 of 24 July 2020 amending Implementing Regulation (EU) No 1263/2011 as regards the authorisation of Lactococcus lactis (NCIMB 30160) as a feed additive for all animal species (Text with EEA relevance)

text:
                  27.7.2020

                  EN

                  Official Journal of the European Union

                  L 241/10

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1092
         of 24 July 2020
         amending Implementing Regulation (EU) No 1263/2011 as regards the authorisation of Lactococcus lactis (NCIMB 30160) 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 13(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 or modifying such authorisation.

                     (2)

                     The use of Lactococcus lactis NCIMB 30160 as a feed additive was authorised for all animal species by Commission Implementing Regulation (EU) No 1263/2011 (2).

                     (3)

                     In accordance with Article 13(1) of Regulation (EC) No 1831/2003, the Commission requested the European Food Safety Authority (‘the Authority’) to issue an opinion on whether the authorisation of Lactococcus lactis (NCIMB 30160) as a feed additive would still meet the conditions laid down in Article 5 of Regulation (EC) No 1831/2003, considering a modification of the terms of that authorisation. The modification relates to the formulation of the additive, consisting of the inclusion of polyethylene glycol (PEG 4000) in the list of cryoprotectants that can be used for the manufacture of the additive. The request was accompanied by the relevant supporting data.

                     (4)

                     The Authority concluded in its opinions of 6 March 2018 (3) and 7 October 2019 (4) that, under the proposed conditions of use, preparations of PEG 4000 as an excipient in formulations with Lactococcus lactis (NCIMB 30160) do not modify the previous conclusions that the additive does not have an adverse effect on animal health, human health or the environment and that it is efficacious as silage additive. Therefore, no safety concerns are expected when PEG 4000 is used as a cryoprotectant in the additive Lactococcus lactis NCIMB 30160 up to a maximum concentration of 0,025 mg PEG 4000/kg silage. The Authority does not consider that there is a need for specific requirements of post-market monitoring.

                     (5)

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

                     (6)

                     Implementing Regulation (EU) No 1263/2011 should therefore be amended accordingly.

                     (7)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            The Annex to Implementing Regulation (EU) No 1263/2011 is amended in accordance with the Annex to this Regulation.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 24 July 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Implementing Regulation (EU) No 1263/2011 of 5 December 2011 concerning the authorisation of Lactobacillus buchneri (DSM 16774), Lactobacillus buchneri (DSM 12856), Lactobacillus paracasei (DSM 16245), Lactobacillus paracasei (DSM 16773), Lactobacillus plantarum (DSM 12836), Lactobacillus plantarum (DSM 12837), Lactobacillus brevis (DSM 12835), Lactobacillus rhamnosus (NCIMB 30121), Lactococcus lactis (DSM 11037), Lactococcus lactis (NCIMB 30160), Pediococcus acidilactici (DSM 16243) and Pediococcus pentosaceus (DSM 12834) as feed additives for all animal species (OJ L 322, 6.12.2011, p. 3).

            (3)  EFSA Journal 2018; 16(3):5218.

            (4)  EFSA Journal 2019; 17(11):5890.

            ANNEX
            In the Annex to Implementing Regulation (EU) No 1263/2011, the entry concerning the additive with the identification number 1k2082 is replaced by the following:

                           Identification number of the additive

                           Additive

                           Composition, chemical formula, description, analytical method

                           Species or category of animal

                           Maximum age

                           Minimum content

                           Maximum content

                           Other provisions

                           End of period of authorisation

                           CFU of additive/kg of fresh material

                              Category of technological additives. Functional group: silage additives

                           ‘1k2082

                              Lactococcus lactis

                           (NCIMB 30160)

                              Additive composition:

                           Preparation of Lactococcus lactis (NCIMB 30160) containing a minimum of 4 × 1011 CFU/g additive
                           One of the following cryoprotectants: ascorbic acid, lactose, mannitol, monosodium glutamate, sodium citrate, whey powder or polyethylene glycol (PEG 4000)

                              Characterisation of the active substance:

                              Lactococcus lactis (NCIMB 30160)

                              Analytical method
                               (1):
                           Enumeration: pour plate method using MSR agar (ISO 15214)
                           Identification: Pulsed-Field Gel Electrophoresis (PFGE)

                           All animal species

                           -

                           -

                           -

                                       1.

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

                                       2.

                                       Minimum content of the additive when used without combination with other micro-organisms as silage additives: 1 × 108 CFU/kg fresh material.

                                       3.

                                       If used as a cryoprotectant, polyethylene glycol (PEG 4000) shall be used up to a maximum concentration of 0,025 mg/kg silage.

                                       4.

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

                           16.8.2030

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


title: Commission Implementing Regulation (EU) 2020/1093 of 24 July 2020 amending Implementing Regulation (EU) No 686/2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of active substances whose approval expires between 31 March 2025 and 27 December 2028 (Text with EEA relevance)

text:
                  27.7.2020

                  EN

                  Official Journal of the European Union

                  L 241/13

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1093
         of 24 July 2020
         amending Implementing Regulation (EU) No 686/2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of active substances whose approval expires between 31 March 2025 and 27 December 2028
         (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 19 thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) No 686/2012 (2) allocates the evaluation of active substances to a rapporteur Member State and to a co-rapporteur Member State for the purposes of the renewal procedure. Since the evaluation of active substances whose approval expires between 31 March 2025 and 27 December 2028 has not yet been allocated to a Member State or to a co-rapporteur Member State, it is appropriate to proceed to such allocation.

                     (2)

                     That allocation should be made in such a way that a balance is achieved as regards the distribution of the responsibilities and the work between Member States.

                     (3)

                     Implementing Regulation (EU) No 686/2012 should therefore be amended accordingly.

                     (4)

                     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
            Implementing Regulation (EU) No 686/2012 is amended in accordance with the Annex to this Regulation.

            Article 2
            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, 24 July 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Implementing Regulation (EU) No 686/2012 of 26 July 2012 allocating to Member States, for the purposes of the renewal procedure, the evaluation of the active substances (OJ L 200, 27.7.2012, p. 5).

            ANNEX
            The Annex to Implementing Regulation (EU) No 686/2012 is amended as follows:
            The following Part D is added:

               ‘PART D

                  Allocation of the evaluation of active substances whose approval expires between 31 March 2025 and 27 December 2028

                           Active substance

                           Rapporteur Member State

                           Co-rapporteur Member State

                           Alpha-cypermethrin

                           FR

                           AT

                              Bacillus amyloliquefaciens subsp. plantarum strain D747

                           NL

                           SK

                              Bacillus amyloliquefaciens strain MBI 600

                           NL

                           SK

                              Beauveria bassiana strain NPP111B005

                           BE

                           RO

                              Beauveria bassiana strain 147

                           BE

                           RO

                           Bentazone

                           PL

                           EL

                           Bordeaux mixture

                           IT

                           PL

                           Chromafenozide

                           CZ

                           MT

                           Copper hydroxide

                           IT

                           PL

                           Copper oxide

                           IT

                           PL

                           Copper oxychloride

                           IT

                           PL

                           Cyantraniliprole

                           ES

                           FI

                           Fenpicoxamid

                           SE

                           BG

                           Flupyradifurone

                           EL

                           PL

                           Gamma-cyhalothrin

                           DE

                           ES

                           Halauxifen-methyl

                           HU

                           SE

                           Isofetamid

                           PT

                           IE

                           Mandestrobin

                           SE

                           NO

                           Meptyldinocap

                           HR

                           DE

                           Methoxyfenozide

                           FR

                           HU

                              Metschnikowia fructicola strain NRRL Y-27328

                           NL

                           HR

                           Oxathiapiprolin

                           NO

                           CZ

                           Pinoxaden

                           FI

                           BE

                           Propyzamide

                           DK

                           DE

                           Rescalure

                           IE

                           PT

                           Sulfoxaflor

                           AT

                           ES

                           Terpenoid blend QRD 460

                           FR

                           DK

                           Tribasic copper sulphate

                           IT

                           PL’


title: Commission Implementing Regulation (EU) 2020/1094 of 24 July 2020 concerning the renewal of the authorisation of the preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for sows and repealing Regulation (EC) No 896/2009 (holder of authorisation Prosol S.p.A.) (Text with EEA relevance)

text:
                  27.7.2020

                  EN

                  Official Journal of the European Union

                  L 241/15

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/1094
         of 24 July 2020
         concerning the renewal of the authorisation of the preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for sows and repealing Regulation (EC) No 896/2009 (holder of authorisation Prosol S.p.A.)
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,
         Whereas:

                     (1)

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

                     (2)

                     The preparation of Saccharomyces cerevisiae MUCL 39885 was authorised for 10 years as a feed additive for sows by Commission Regulation (EC) No 896/2009 (2).

                     (3)

                     In accordance with Article 14(1) of Regulation (EC) No 1831/2003, an application was submitted by the holder of that authorisation for the renewal of the authorisation of the preparation of Saccharomyces cerevisiae MUCL 39885 as a feed additive for sows, requesting that additive to be classified in the additive category ‘zootechnical additives’. That application was accompanied by the particulars and documents required under Article 14(2) of Regulation (EC) No 1831/2003.

                     (4)

                     The European Food Safety Authority (‘the Authority’) concluded in its opinion of 14 May 2019 (3) that the applicant has provided data demonstrating that the additive complies with the conditions of authorisation. The Authority concluded that Saccharomyces cerevisiae MUCL 39885 does not have an adverse effect under the authorised conditions of use for the animal health, consumers, or the environment. The Authority also concluded that the additive is considered a potential skin and eye irritant and a potential skin and respiratory sensitiser. Therefore, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

                     (5)

                     The assessment of Saccharomyces cerevisiae MUCL 39885 shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the authorisation of that additive should be renewed as specified in the Annex to this Regulation.

                     (6)

                     As a consequence of the renewal of the authorisation of Saccharomyces cerevisiae MUCL 39885 as a feed additive under the conditions laid down in the Annex to this Regulation, Regulation (EC) No 896/2009 should be repealed.

                     (7)

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

               HAS ADOPTED THIS REGULATION:

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

            Article 2
            Regulation (EC) No 896/2009 is repealed.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 24 July 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Regulation (EC) No 896/2009 of 25 September 2009 concerning the authorisation of a new use of Saccharomyces cerevisiae MUCL 39885 as a feed additive for sows (holder of the authorisation Prosol SpA) (OJ L 256, 29.9.2009, p. 6).

            (3)  EFSA Journal 2019; 17(6):5719.

            ANNEX

                           Identification number of the additive

                           Name of the holder of authorisation

                           Additive

                           Composition, chemical formula, description, analytical method

                           Species or category of animal

                           Maximum age

                           Minimum content

                           Maximum content

                           Other provisions

                           End of period of authorisation

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

                           Category of zootechnical additives. Functional group: gut flora stabilisers.

                        4b1710

                        Prosol
                        S.p.A.

                           Saccharomyces cerevisiae

                        MUCL 39885

                           Additive composition

                        Preparation of Saccharomyces cerevisiae

                        MUCL 39885
                        Powder and granulated form containing a minimum of 1 × 109 CFU/g additive

                        Sows

                        -

                        6,4 × 109

                        -

                                    1.

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

                                    2.

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

                        16.8.2030

                           Characterisation of active substance

                        Viable cells of Saccharomyces cerevisiae MUCL 39885

                           Analytical method
                            (1)

                        Enumeration: pour plate method using chloramphenicol glucose yeast extract agar (EN 15789:2009).
                        Identification: polymerase chain reaction (PCR) method

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