title: Commission Implementing Regulation (EU) 2018/1260 of 20 September 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances pyridaben, quinmerac and zinc phosphide (Text with EEA relevance.)

text:
                  21.9.2018

                  EN

                  Official Journal of the European Union

                  L 238/30

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1260
         of 20 September 2018
         amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances pyridaben, quinmerac and zinc phosphide
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the first paragraph of Article 17 thereof,
         Whereas:

                     (1)

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

                     (2)

                     The active substances pyridaben, quinmerac and zinc phosphide are included in part A of the Annex to Implementing Regulation (EU) No 540/2011.

                     (3)

                     The approval periods of the substances pyridaben, quinmerac and zinc phosphide will expire on 30 April 2021.

                     (4)

                     Applications for the renewal of the approval of the active substances included in this Regulation were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (3). However, the approval of those substances is likely to expire for reasons beyond the control of the applicant before a decision has been taken on the renewal of their approval. It is therefore necessary to extend their approval periods in accordance with Article 17 of Regulation (EC) No 1107/2009.

                     (5)

                     In view of the time and resources necessary for completing the assessment of applications for renewal of approvals of large number of active substances the approvals of which are expiring between 2019 and 2021, Commission Implementing Decision C(2016) 6104 (4) established a work programme grouping together similar active substances and setting priorities on the basis of safety concerns for human and animal health or the environment as provided for in Article 18 of Regulation (EC) No 1107/2009.

                     (6)

                     As the active substances included in this Regulation do not fall in the prioritised categories of Implementing Decision C(2016) 6104, their approval period should be extended by either two or three years, taking into account the current date of expiry, the fact that in accordance with Article 6(3) of Implementing Regulation (EU) No 844/2012 the supplementary dossier for an active substance is to be submitted no later than 30 months before expiry of the approval, the need to ensure a balanced distribution of responsibilities and work among Member States acting as rapporteurs and co-rapporteurs and the available resources necessary for assessment and decision-making. It is therefore appropriate to extend the approval period for the active substance pyridaben by two years, and to extend the approval periods of the active substances quinmerac and zinc phosphide by three years.

                     (7)

                     In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where no supplementary dossier in accordance with Implementing Regulation (EU) No 844/2012 is submitted no later than 30 months before the respective expiry date laid down in the Annex to this Regulation, the Commission will set the expiry date at the same date as before this Regulation or at the earliest date thereafter.

                     (8)

                     In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission will adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission will adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.

                     (9)

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

                     (10)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Part A of the Annex to Implementing Regulation (EU) No 540/2011 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, 20 September 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

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

            (3)  Commission Implementing Regulation (EU) No 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).

            (4)  Commission Implementing Decision of 28 September 2016 on the establishment of a work programme for the assessment of applications for the renewal of approvals of active substances expiring in 2019, 2020 and 2021 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council (OJ C 357, 29.9.2016, p. 9).

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

                        (1)

                        in the sixth column, expiration of approval, of row 311, Quinmerac, the date is replaced by ‘30 April 2024’;

                        (2)

                        in the sixth column, expiration of approval, of row 313, Pyridaben, the date is replaced by ‘30 April 2023’;

                        (3)

                        in the sixth column, expiration of approval, of row 314, Zinc phosphide, the date is replaced by ‘30 April 2024’.


title: Commission Implementing Regulation (EU) 2018/1262 of 20 September 2018 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, clomazone, cypermethrin, daminozide, deltamethrin, dimethenamid-p, diuron, fludioxonil, flufenacet, flurtamone, fosthiazate, indoxacarb, MCPA, MCPB, prosulfocarb, thiophanate-methyl and tribenuron (Text with EEA relevance.)

text:
                  21.9.2018

                  EN

                  Official Journal of the European Union

                  L 238/62

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1262
         of 20 September 2018
         amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, clomazone, cypermethrin, daminozide, deltamethrin, dimethenamid-p, diuron, fludioxonil, flufenacet, flurtamone, fosthiazate, indoxacarb, MCPA, MCPB, prosulfocarb, thiophanate-methyl and tribenuron
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the first paragraph of Article 17 thereof,
         Whereas:

                     (1)

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

                     (2)

                     The approval periods of the active substances 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, cypermethrin, daminozide, deltamethrin, dimethenamid-p, flufenacet, flurtamone, fosthiazate, indoxacarb, MCPA, MCPB, thiophanate-methyl and tribenuron were last extended by Commission Implementing Regulation (EU) 2017/1511 (3). The approval periods of those substances will expire on 31 October 2018.

                     (3)

                     The approval period of the active substance diuron will expire on 30 September 2018.

                     (4)

                     The approval periods of the active substances clomazone, fludioxonil and prosulfocarb will expire on 31 October 2018.

                     (5)

                     Applications for the renewal of the approval of those substances were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (4).

                     (6)

                     Due to the fact that the assessment of those substances has been delayed for reasons beyond the control of the applicants, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

                     (7)

                     In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission will adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission will set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission will adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.

                     (8)

                     Taking into account that the approval of the active substance diuron expires on 30 September 2018, this Regulation should enter into force as soon as possible.

                     (9)

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

                     (10)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            Part A of the Annex to Implementing Regulation (EU) No 540/2011 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, 20 September 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

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

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

            (3)  Commission Implementing Regulation (EU) 2017/1511 of 30 August 2017 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-methylcyclopropene, beta-cyfluthrin, chlorothalonil, chlorotoluron, cypermethrin, daminozide, deltamethrin, dimethenamid-p, flufenacet, flurtamone, forchlorfenuron, fosthiazate, indoxacarb, iprodione, MCPA, MCPB, silthiofam, thiophanate-methyl and tribenuron (OJ L 224, 31.8.2017, p. 115).

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

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

                        (1)

                        in the sixth column, expiration of approval, of row 40, Deltamethrin, the date is replaced by ‘31 October 2019’;

                        (2)

                        in the sixth column, expiration of approval, of row 48, Beta-cyfluthrin, the date is replaced by ‘31 October 2019’;

                        (3)

                        in the sixth column, expiration of approval, of row 64, Flurtamone, the date is replaced by ‘31 October 2019’;

                        (4)

                        in the sixth column, expiration of approval, of row 65, Flufenacet, the date is replaced by ‘31 October 2019’;

                        (5)

                        in the sixth column, expiration of approval, of row 67, Dimethenamid-p, the date is replaced by ‘31 October 2019’;

                        (6)

                        in the sixth column, expiration of approval, of row 69, Fosthiazate, the date is replaced by ‘31 October 2019’;

                        (7)

                        in the sixth column, expiration of approval, of row 101, Chlorothalonil, the date is replaced by ‘31 October 2019’;

                        (8)

                        in the sixth column, expiration of approval, of row 102, Chlorotoluron, the date is replaced by ‘31 October 2019’;

                        (9)

                        in the sixth column, expiration of approval, of row 103, Cypermethrin, the date is replaced by ‘31 October 2019’;

                        (10)

                        in the sixth column, expiration of approval, of row 104, Daminozide, the date is replaced by ‘31 October 2019’;

                        (11)

                        in the sixth column, expiration of approval, of row 105, Thiophanate-methyl, the date is replaced by ‘31 October 2019’;

                        (12)

                        in the sixth column, expiration of approval, of row 106, Tribenuron, the date is replaced by ‘31 October 2019’;

                        (13)

                        in the sixth column, expiration of approval, of row 107, MCPA, the date is replaced by ‘31 October 2019’;

                        (14)

                        in the sixth column, expiration of approval, of row 108, MCPB, the date is replaced by ‘31 October 2019’;

                        (15)

                        in the sixth column, expiration of approval, of row 117, 1-methylcyclopropene, the date is replaced by ‘31 October 2019’;

                        (16)

                        in the sixth column, expiration of approval, of row 119, Indoxacarb, the date is replaced by ‘31 October 2019’;

                        (17)

                        in the sixth column, expiration of approval, of row 160, Prosulfocarb, the date is replaced by ‘31 October 2019’;

                        (18)

                        in the sixth column, expiration of approval, of row 161, Fludioxonil, the date is replaced by ‘31 October 2019’;

                        (19)

                        in the sixth column, expiration of approval, of row 162, Clomazone, the date is replaced by ‘31 October 2019’;

                        (20)

                        in the sixth column, expiration of approval, of row 192, Diuron, the date is replaced by ‘30 September 2019’.


title: Commission Implementing Regulation (EU) 2018/1258 of 18 September 2018 granting a Union authorisation for the biocidal product family Ecolab Iodine PT3 Family (Text with EEA relevance.)

text:
                  21.9.2018

                  EN

                  Official Journal of the European Union

                  L 238/3

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1258
         of 18 September 2018
         granting a Union authorisation for the biocidal product family Ecolab Iodine PT3 Family
         (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 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5) thereof,
         Whereas:

                     (1)

                     On 23 July 2015, Ecolab Deutschland GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named Ecolab Iodine PT3 Family (‘the product family’) of product-type 3, as described in Annex V to that Regulation. The Netherlands agreed that their competent authority referred to in Article 43(1) of Regulation (EU) No 528/2012 evaluate this application. The application was recorded under the case number BC-VG018734-32 in the Register for Biocidal Products (‘the Register’).

                     (2)

                     The biocidal product family contains iodine, including polyvinylpyrrolidone iodine, as active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012. Taking into account the intrinsic properties of the active substance, once the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (2) will become applicable, the Commission will consider the need to review the approval of iodine, including polyvinylpyrrolidone iodine, in accordance with Article 15 of Regulation (EU) No 528/2012. Depending on the outcome of that review, the Commission will then consider whether the Union authorisations for products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012.

                     (3)

                     On 6 June 2017, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

                     (4)

                     On 12 January 2018, the Agency submitted to the Commission an opinion (3), including the draft summary of the biocidal product characteristics (‘SPC’) and the final assessment report on the product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concluded that the product family falls within the definition of ‘biocidal product family’ laid down in Article 3(1)(s) of Regulation (EU) No 528/2012, that it was found eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, the product family meets the conditions laid down in Article 19(1) and (6) of that Regulation.

                     (5)

                     On 26 February 2018, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

                     (6)

                     The Commission concurs with the opinion of the Agency and considers therefore appropriate to grant a Union authorisation for the biocidal product family, and to record the SPC and the assessment report on the product family in the Register in accordance with Article 71(6) of Regulation (EU) No 528/2012.

                     (7)

                     The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

               HAS ADOPTED THIS REGULATION:

            Article 1
            A Union authorisation is granted to Ecolab Deutschland GmbH for the biocidal product family Ecolab Iodine PT3 Family with authorisation number EU-0018398-0000.
            The Union authorisation is valid from 11 October 2018 until 30 September 2028.
            The Union authorisation is subject to compliance with the SPC set out in the 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, 18 September 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 167, 27.6.2012, p. 1.

            (2)  Commission delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).

            (3)  ECHA opinion of 12 December 2017 on the Union authorisation of Ecolab Iodine PT3 Family (ECHA/BPC/177/2017).

            ANNEX

               Summary of product characteristics for a biocidal product family

            Ecolab Iodine PT3 Family
            Product type 3 — Veterinary hygiene (Disinfectants)
            Authorisation number: EU-0018398-0000
            R4BP asset number: EU-0018398-0000
            PART I

               FIRST INFORMATION LEVEL

            1.   ADMINISTRATIVE INFORMATION

            1.1.   Family name

                        Name

                        Ecolab Iodine PT3 Family

                  1.2.   Product type(s)

                        Product type(s)

                        PT03 — Veterinary hygiene (Disinfectants)

                  1.3.   Authorisation holder

                        Name and address of the authorisation holder

                        Name

                        Ecolab Deutschland GmbH

                        Address

                        Ecolab-Allee 1, 40789 Monheim, Germany

                        Authorisation number

                        EU-0018398-0000

                           R4BP asset number

                        EU-0018398-0000

                        Date of the authorisation

                        11 October 2018

                        Expiry date of the authorisation

                        30 September 2028

                  1.4.   Manufacturer(s) of the biocidal products

                        Name of manufacturer

                        Ecolab Europe GmbH

                        Address of manufacturer

                        Richtistrasse 7, 8304 Walliselen Switzerland

                        Location of manufacturing sites

                        Ecolab Baglan, ECOLAB CONTAMINATION CONTROL BRUNEL WAY, BAGLAN ENERGY PARK, NEATH, SA11 2GA South Wales United Kingdom
                        Ecolab Leeds, LOTHERTON WAY, GARFORTH, LEEDS LS25 2JY Leeds United Kingdom
                        Ecolab Rovigo, Viale del Lavoro 10, 45100 Rovigo Italy
                        Ecolab Biebesheim Nalco Deutschland Manufacturing GmbH und Co.KG, Justus-von-Liebig-Str. 11 D-64584 Biebesheim Germany
                        Ecolab NETHERLANDS BV, NL01ECOLAB, BRUGWAL 11 3432NZ NIEUWEGEIN Netherlands
                        Ecolab Weavergate, ECOLAB WEAVERGATE PLANT WINNINGTON AVENUE, NORTHWICH CHESHIRE CW8 3AA NORTHWICH United Kingdom
                        Ecolab Mullingar, Forest Park, Mullingar Ind. Estate, Mullingar, Co. Zone C Westmeath Ireland
                        Ecolab Maribor, Ecolab d.o.o.,Vajngerlova 4 2000 Maribor Slovenia
                        Ecolab Rozzano, VIA GRANDI 9/11 20089 ROZZANO Italy
                        Ecolab B.V.B.A, Havenlaan: 4 3980 Tessenderlo Belgium
                        Ecolab CELRA, Nalco Española Manufacturing, SLU C/Tramuntana s/n, Polígono Industrial de Celrà 17460 CELRÀ Spain
                        Ecolab Chalons Ecolab production France SAS, BP509 Avenue de Général Patton 51006 Châlons-en-Champagne France
                        Ecolab Mandra, 25km Old National Road Athens Mandra, oo Attica Greece
                        NALCO FINLAND MANUFACTURING OY, Kivikummuntie 1 FIN-07955 Tesjoki Finland

                  1.5.   Manufacturer(s) of the active substance(s)

                        Active substance

                        Polyvinylpyrrolidone iodine

                        Name of manufacturer

                        ISP Chemicals LLC, Affiliate of Ashland Inc.

                        Address of manufacturer

                        455 N. MAIN ST. (HWY 95) KY 42029 CALVERT CITY United States

                        Location of manufacturing sites

                        455 N. MAIN ST. (HWY 95) KY 42029 CALVERT CITY United States

                        Active substance

                        Iodine

                        Name of manufacturer

                        ACF Minera S.A.

                        Address of manufacturer

                        San Martín No 499 00 Iquique Chile

                        Location of manufacturing sites

                        Lagunas mine 00 Pozo Almonte Chile

                        Active substance

                        Iodine

                        Name of manufacturer

                        SQM S.A.

                        Address of manufacturer

                        Los Militares 4290 Piso 4 Santiago Chile

                        Location of manufacturing sites

                        Nueva Victoria plant 00 Pedro de Valdivia Chile

                        Active substance

                        Iodine

                        Name of manufacturer

                        Cosayach Nitratos S.A.

                        Address of manufacturer

                        Amunategui 178 00 Santiago Chile

                        Location of manufacturing sites

                        S.C.M. Cosayach Cala Cala 00 Pozo Almonte Chile

                        Active substance

                        Iodine

                        Name of manufacturer

                        Nihon Tennen Gas Development Co., Ltd/ Kanto Natural Gas Development Co., Ltd

                        Address of manufacturer

                        661 Mobara Chiba 297-8550 Mobara City Japan

                        Location of manufacturing sites

                        Chiba Plant, 2508 Minami-Hinata, Shirako-Machi, Chosei-Gun 299-4205 Chiba Japan

                  2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

            2.1.   Qualitative and quantitative information on the composition of the family

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Polyvinylpyrrolidone iodine

                        Active substance

                        25655-41-8

                        1

                        3

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,11

                        0,33

                  2.2.   Type(s) of formulation

                        Formulation(s)

                        AL — Any other liquid

                  PART II

               SECOND INFORMATION LEVEL — META SPC(S)

               META SPC 1

            1.   META SPC 1 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 1 identifier

                        Identifier

                        meta SPC 1

                  1.2.   Suffix to the authorisation number

                        Number

                        1-1

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 — Veterinary hygiene (Disinfectants)

                  2.   META SPC 1 COMPOSITION
            2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Polyvinylpyrrolidone iodine

                        Active substance

                        25655-41-8

                        1

                        1

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,11

                        0,11

                  2.2.   Type(s) of formulation of the meta SPC 1

                        Formulation

                        AL — Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

                        Hazard statements

                        Precautionary statements

                  4.   AUTHORISED USE(S) OF THE META SPC 1
            4.1.   Use description

               Table 1. Use # 1 – Teat dips for post-milking disinfection

                        Product Type

                        PT03 — Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts
                        Enveloped viruses

                        Field(s) of use

                        Indoor
                        Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)

                        Application method(s)

                        Manual dipping using a dip cup -
                        3-10 ml (dipping)
                        1-3 post-milking disinfections per day

                        Application rate(s) and frequency

                        3-10 ml (dipping)
                        Post-milking application 1x - 3x per day (apply after every milking).
                        Per milking event 3-10 ml of product are needed (animals with four teats).

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        container, Plastic: HDPE, 0,5-1 000  l

                  4.1.1.   Use-specific instructions for use

            See general directions for use of meta SPC 1
            4.1.2.   Use-specific risk mitigation measures

            See general directions for use of meta SPC 1
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See general directions for use of meta SPC 1
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use of meta SPC 1
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            See general directions for use of meta SPC 1
            5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1
            5.1.   Instructions for use

            Always read the label or leaflet before use and follow all the instructions provided.
            Product to be applied post-milking by use of a dipping cup.
            The products must be brought to temperatures above 20 °C before use.
            Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.
            The use of a dosing pump for filling the product into the application equipment is recommended.
            5.2.   Risk mitigation measures

            In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Potential Health Effects
            Eyes: Health injuries are not known or expected under normal use.
            Skin: Health injuries are not known or expected under normal use.
            Ingestion: Health injuries are not known or expected under normal use.
            Inhalation: Health injuries are not known or expected under normal use.
            Chronic Exposure: Health injuries are not known or expected under normal use.
            First Aid Measures:
            Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.
            Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.
            Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.
            Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.
            Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.
            5.4.   Instructions for safe disposal of the product and its packaging

            At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
            European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.
            Shelf life: 24 months
            6.   OTHER INFORMATION
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        Ioklar Super Dip D

                        Authorisation number

                        EU-0018398-0001 1-1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Polyvinylpyrrolidone iodine

                        Active substance

                        25655-41-8

                        1

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,11

                  7.2.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        IoKlar Superdip

                        Authorisation number

                        EU-0018398-0002 1-1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Polyvinylpyrrolidone iodine

                        Active substance

                        25655-41-8

                        1

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,11

               META SPC 2

            1.   META SPC 2 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 2 identifier

                        Identifier

                        meta SPC 2

                  1.2.   Suffix to the authorisation number

                        Number

                        1-2

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 — Veterinary hygiene (Disinfectants)

                  2.   META SPC 2 COMPOSITION
            2.1.   Qualitative and quantitative information on the composition of the meta SPC 2

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Polyvinylpyrrolidone iodine

                        Active substance

                        25655-41-8

                        1,35

                        1,35

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,15

                        0,15

                  2.2.   Type(s) of formulation of the meta SPC 2

                        Formulation

                        AL — Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

                        Hazard statements

                        Precautionary statements

                  4.   AUTHORISED USE(S) OF THE META SPC 2
            4.1.   Use description

               Table 2. Use # 1 – Teat dips for post-milking disinfection

                        Product Type

                        PT03 — Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts
                        Enveloped viruses

                        Field(s) of use

                        Indoor
                        Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)

                        Application method(s)

                        Manual dipping using a dip cup

                        Application rate(s) and frequency

                        Post-milking application 1x - 3x per day (apply after every milking).
                        Per milking event 3-10 ml of product are needed (animals with four teats).

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        0,5 l – 1 000  l HDPE container

                  4.1.1.   Use-specific instructions for use

            See general directions for use of meta SPC 2
            4.1.2.   Use-specific risk mitigation measures

            See general directions for use of meta SPC 2
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See general directions for use of meta SPC 2
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use of meta SPC 2
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            See general directions for use of meta SPC 2
            5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2
            5.1.   Instructions for use

            Always read the label or leaflet before use and follow all the instructions provided.
            The products must be brought to temperatures above 20 °C before use.
            Product to be applied post-milking by use of a dipping cup.
            Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.
            The use of a dosing pump for filling the product into the application equipment is recommended.
            5.2.   Risk mitigation measures

            In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Potential Health Effects
            Eyes: Health injuries are not known or expected under normal use.
            Skin: Health injuries are not known or expected under normal use.
            Ingestion: Health injuries are not known or expected under normal use.
            Inhalation: Health injuries are not known or expected under normal use.
            Chronic Exposure: Health injuries are not known or expected under normal use.
            First Aid Measures:
            Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.
            Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.
            Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.
            Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.
            Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.
            5.4.   Instructions for safe disposal of the product and its packaging

            At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
            European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.
            Shelf life: 24 months
            6.   OTHER INFORMATION
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        Io-Shield D
                        IoShield
                        MEPA Barrier D
                        BARIOPROTECT
                        MS Cow Udder BLOCK
                        Iodocop EXTRA

                        Authorisation number

                        EU-0018398-0003 1-2

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Polyvinylpyrrolidone iodine

                        Active substance

                        25655-41-8

                        1,35

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,15

                  7.2.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        IoDark
                        Iodocop EXTRA GREEN
                        Mammizan Protect
                        MS Cow Udder BLACK

                        Authorisation number

                        EU-0018398-0004 1-2

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Polyvinylpyrrolidone iodine

                        Active substance

                        25655-41-8

                        1,35

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,15

               META SPC 3

            1.   META SPC 3 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 3 identifier

                        Identifier

                        meta SPC 3

                  1.2.   Suffix to the authorisation number

                        Number

                        1-3

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 — Veterinary hygiene (Disinfectants)

                  2.   META SPC 3 COMPOSITION
            2.1.   Qualitative and quantitative information on the composition of the meta SPC 3

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Polyvinylpyrrolidone iodine

                        Active substance

                        25655-41-8

                        2,45

                        2,45

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,27

                        0,27

                  2.2.   Type(s) of formulation of the meta SPC 3

                        Formulation

                        AL — Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

                        Hazard statements

                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Avoid release to the environment.

                  4.   AUTHORISED USE(S) OF THE META SPC 3
            4.1.   Use description

               Table 3. Use # 1 – Teat dips or sprays for post-milking disinfection

                        Product Type

                        PT03 — Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts
                        Enveloped viruses

                        Field(s) of use

                        Indoor
                        Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)

                        Application method(s)

                        Dipping or spraying:
                        Manual dipping using a dip cup or
                        Manual spraying using a trigger sprayer or
                        Manual spraying using an electronic sprayer or
                        Automated spraying by robot.

                        Application rate(s) and frequency

                        Post-milking application 1x – 3x per day
                        Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats).

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        0,5 l – 1 000  l HDPE container

                  4.1.1.   Use-specific instructions for use

            Product to be applied by dipping or spraying on teats of milk-producing animals post-milking, using manual or automatic equipment. Post-milking: Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.
            See also general instructions for use of meta SPC 3.
            4.1.2.   Use-specific risk mitigation measures

            In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
            See also general risk mitigation measures of meta SPC 3.
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See general directions for use of meta SPC 3
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use of meta SPC 3
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            See general directions for use of meta SPC 3
            4.2.   Use description

               Table 4. Use # 2 – Teat dips or sprays for pre-milking disinfection

                        Product Type

                        PT03 — Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts

                        Field(s) of use

                        Indoor
                        Pre-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)

                        Application method(s)

                        Dipping or spraying:
                        Manual dipping using a dip cup or
                        Manual spraying using a trigger sprayer or
                        Manual spraying using an electronic sprayer.

                        Application rate(s) and frequency

                        Pre-milking application 1x – 3x per day
                        Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats).

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        0,5 l – 1 000  l HDPE container

                  4.2.1.   Use-specific instructions for use

            Product to be applied by dipping or spraying on teats of milk-producing animals pre-milking, using manual equipment.
            Pre-milking: Clean teats by wiping with cloth before disinfection. Apply product on the whole teats and leave it for 1 min. Then wipe with a single use paper or a towel.
            See also general instructions for use of meta SPC3.
            4.2.2.   Use-specific risk mitigation measures

            In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.
            See also general risk mitigation measures of meta SPC3.
            4.2.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See general directions for use of meta SPC 3
            4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use of meta SPC 3
            4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            See general directions for use of meta SPC 3
            5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3
            5.1.   Instructions for use

            See use-specific instructions for each use.
            Always read the label or leaflet before use and follow all the instructions provided.
            The products must be brought to temperatures above 20 °C before use.
            The use of a dosing pump for filling the product into the application equipment is recommended
            5.2.   Risk mitigation measures

            See use-specific risk mitigation measures for each use.
            Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) for spraying application.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Potential Health Effects
            Eyes: Health injuries are not known or expected under normal use.
            Skin: Health injuries are not known or expected under normal use.
            Ingestion: Health injuries are not known or expected under normal use.
            Inhalation: Health injuries are not known or expected under normal use.
            Chronic Exposure: Health injuries are not known or expected under normal use.
            First Aid Measures:
            Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.
            Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.
            Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.
            Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.
            Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.
            5.4.   Instructions for safe disposal of the product and its packaging

            At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
            European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.
            Shelf life: 24 months
            6.   OTHER INFORMATION
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        IoKlar Multi
                        MEPA Iospray Plus D
                        ASTRI-IO
                        DESINTEC MH-Iodine S

                        Authorisation number

                        EU-0018398-0005 1-3

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Polyvinylpyrrolidone iodine

                        Active substance

                        25655-41-8

                        2,45

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,27

               META SPC 4

            1.   META SPC 4 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 4 identifier

                        Identifier

                        meta SPC 4

                  1.2.   Suffix to the authorisation number

                        Number

                        1-4

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 — Veterinary hygiene (Disinfectants)

                  2.   META SPC 4 COMPOSITION
            2.1.   Qualitative and quantitative information on the composition of the meta SPC 4

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Polyvinylpyrrolidone iodine

                        Active substance

                        25655-41-8

                        1

                        1

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,11

                        0,11

                  2.2.   Type(s) of formulation of the meta SPC 4

                        Formulation

                        AL — Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

                        Hazard statements

                        Precautionary statements

                  4.   AUTHORISED USE(S) OF THE META SPC 4
            4.1.   Use description

               Table 5. Use # 1 – Teat dips or sprays for post-milking disinfection

                        Product Type

                        PT03 — Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts
                        Enveloped viruses

                        Field(s) of use

                        Indoor
                        Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)

                        Application method(s)

                        Dipping or spraying:
                        Manual dipping using a dip cup or
                        Manual spraying using a trigger sprayer or
                        Manual spraying using an electronic sprayer or
                        Automated spraying by robot.

                        Application rate(s) and frequency

                        Post-milking application 1x - 3x per day.
                        Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats).

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        0,5 l – 1 000  l HDPE container

                  4.1.1.   Use-specific instructions for use

            See general directions for use of meta SPC 4
            4.1.2.   Use-specific risk mitigation measures

            See general directions for use of meta SPC 4
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See general directions for use of meta SPC 4
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use of meta SPC 4
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            See general directions for use of meta SPC 4
            5.   GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4
            5.1.   Instructions for use

            Always read the label or leaflet before use and follow all the instructions provided.
            The products must be brought to temperatures above 20 °C before use.
            Product to be applied by dipping or spraying on teats of milk-producing animals post-milking using manual or automatic equipment.
            Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.
            The use of a dosing pump for filling the product into the application equipment is recommended.
            5.2.   Risk mitigation measures

            Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) for spraying application.
            In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Potential Health Effects
            Eyes: Health injuries are not known or expected under normal use.
            Skin: Health injuries are not known or expected under normal use.
            Ingestion: Health injuries are not known or expected under normal use.
            Inhalation: Health injuries are not known or expected under normal use.
            Chronic Exposure: Health injuries are not known or expected under normal use.
            First Aid Measures:
            Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.
            Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.
            Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.
            Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.
            Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.
            5.4.   Instructions for safe disposal of the product and its packaging

            At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
            European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.
            Shelf life: 24 months
            6.   OTHER INFORMATION
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        Veloucid Spray D
                        VelouCid Spray
                        MEPA Soft Spray D
                        ASTRI-UC
                        SAC WINTERSPRAY

                        Authorisation number

                        EU-0018398-0006 1-4

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Polyvinylpyrrolidone iodine

                        Active substance

                        25655-41-8

                        1

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,11

               META SPC 5

            1.   META SPC 5 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 5 identifier

                        Identifier

                        meta SPC 5

                  1.2.   Suffix to the authorisation number

                        Number

                        1-5

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 — Veterinary hygiene (Disinfectants)

                  2.   META SPC 5 COMPOSITION
            2.1.   Qualitative and quantitative information on the composition of the meta SPC 5

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Polyvinylpyrrolidone iodine

                        Active substance

                        25655-41-8

                        1

                        1

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,11

                        0,11

                  2.2.   Type(s) of formulation of the meta SPC 5

                        Formulation

                        AL — Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

                        Hazard statements

                        Precautionary statements

                  4.   AUTHORISED USE(S) OF THE META SPC 5
            4.1.   Use description

               Table 6. Use # 1 – Teat dips for post-milking disinfection

                        Product Type

                        PT03 — Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts
                        Enveloped viruses

                        Field(s) of use

                        Indoor
                        Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)

                        Application method(s)

                        Dipping
                        Manual dipping using a dip cup.

                        Application rate(s) and frequency

                        Post-milking application 1x – 3x per day
                        Per milking event 3-10 ml of product are needed (animals with four teats).

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        0,5 l – 1 000  l HDPE container

                  4.1.1.   Use-specific instructions for use

            See general directions for use of meta SPC 5
            4.1.2.   Use-specific risk mitigation measures

            See general directions for use of meta SPC 5
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See general directions for use of meta SPC 5
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use of meta SPC 5
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            See general directions for use of meta SPC 5
            5.   GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5
            5.1.   Instructions for use

            Always read the label or leaflet before use and follow all the instructions provided.
            The products must be brought to temperatures above 20 °C before use.
            Product to be applied post-milking by use of a dipping cup.
            Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.
            The use of a dosing pump for filling the product into the application equipment is recommended.
            5.2.   Risk mitigation measures

            In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Potential Health Effects
            Eyes: Health injuries are not known or expected under normal use.
            Skin: Health injuries are not known or expected under normal use.
            Ingestion: Health injuries are not known or expected under normal use.
            Inhalation: Health injuries are not known or expected under normal use.
            Chronic Exposure: Health injuries are not known or expected under normal use.
            First Aid Measures:
            Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.
            Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.
            Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.
            Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.
            Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.
            5.4.   Instructions for safe disposal of the product and its packaging

            At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
            European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.
            Shelf life: 18 months
            6.   OTHER INFORMATION
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        Veloucid D
                        VelouCid
                        MEPA Care D
                        Cremadip
                        MS Cow Udder SEPIA

                        Authorisation number

                        EU-0018398-0007 1-5

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Polyvinylpyrrolidone iodine

                        Active substance

                        25655-41-8

                        1

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,11

               META SPC 6

            1.   META SPC 6 ADMINISTRATIVE INFORMATION
            1.1.   Meta SPC 6 identifier

                        Identifier

                        meta SPC 6

                  1.2.   Suffix to the authorisation number

                        Number

                        1-6

                  1.3.   Product type(s)

                        Product type(s)

                        PT03 — Veterinary hygiene (Disinfectants)

                  2.   META SPC 6 COMPOSITION
            2.1.   Qualitative and quantitative information on the composition of the meta SPC 6

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Min

                        Max

                        Polyvinylpyrrolidone iodine

                        Active substance

                        25655-41-8

                        1,35

                        1,35

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,15

                        0,15

                  2.2.   Type(s) of formulation of the meta SPC 6

                        Formulation

                        AL — Any other liquid

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

                        Hazard statements

                        Precautionary statements

                  4.   AUTHORISED USE(S) OF THE META SPC 6
            4.1.   Use description

               Table 7. Use # 1 – Teat dips or sprays for post-milking disinfection

                        Product Type

                        PT03 — Veterinary hygiene (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        —

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts
                        Enveloped viruses

                        Field(s) of use

                        Indoor
                        Post-milking disinfection of teats of milk-producing animals (cows, buffaloes, goats, sheep)

                        Application method(s)

                        Dipping or spraying:
                        Manual dipping using a dip cup or
                        Manual spraying using a trigger sprayer or
                        Manual spraying using an electronic sprayer or
                        Automated spraying by robot.

                        Application rate(s) and frequency

                        Post-milking application 1x – 3x per day
                        Per milking event 3-10 ml (dipping) to 10-15 ml (spraying) of product are needed (animals with four teats).

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        0,5 l – 1 000  l HDPE container

                  4.1.1.   Use-specific instructions for use

            See general directions for use of meta SPC 6
            4.1.2.   Use-specific risk mitigation measures

            See general directions for use of meta SPC 6
            4.1.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            See general directions for use of meta SPC 6
            4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use of meta SPC 6
            4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

            See general directions for use of meta SPC 6
            5.   GENERAL DIRECTIONS FOR USE (6) OF THE META SPC 6
            5.1.   Instructions for use

            Always read the label or leaflet before use and follow all the instructions provided.
            The products must be brought to temperatures above 20 °C before use.
            Product to be applied by dipping or spraying post-milking using manual or automatic equipment.
            Apply product on the whole teat and do not wipe it. Keep the animals standing for 5 min. Before the next milking, carefully clean the teats.
            The use of a dosing pump for filling the product into the application equipment is recommended.
            5.2.   Risk mitigation measures

            Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) for spraying application
            In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Potential Health Effects
            Eyes: Health injuries are not known or expected under normal use.
            Skin: Health injuries are not known or expected under normal use.
            Ingestion: Health injuries are not known or expected under normal use.
            Inhalation: Health injuries are not known or expected under normal use.
            Chronic Exposure: Health injuries are not known or expected under normal use.
            First Aid Measures:
            Eye contact: Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses. Get medical attention if irritation occurs.
            Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. In case of inhalation of decomposition products in a fire, symptoms may be delayed. Get medical attention if symptoms occur.
            Skin contact: Flush contaminated skin with plenty of water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur.
            Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if symptoms occur.
            Environmental emergency measures: Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). To prevent malfunctioning of an individual wastewater treatment plant, possible residues containing the product must be discharged to the manure storage (for spreading on agricultural soils or fermentation into biogas installation) or to the municipal sewer If legally allowed.
            5.4.   Instructions for safe disposal of the product and its packaging

            At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
            European Waste Catalogue: 200130-detergents other than those mentioned in 20 01 29.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Store between 5 °C and 25 °C and away from direct sunlight. Keep out of reach of children. Keep container tightly closed. Store in the original containers.
            Shelf life: 24 months
            6.   OTHER INFORMATION
            7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6
            7.1.   Trade name(s), authorisation number and specific composition of each individual product

                        Trade name(s)

                        MEPA Barrier Spray D
                        IoShield Spray
                        QUARESS-Barrier

                        Authorisation number

                        EU-0018398-0008 1-6

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Polyvinylpyrrolidone iodine

                        Active substance

                        25655-41-8

                        1,35

                        Iodine

                        Active substance

                        7553-56-2

                        231-442-4

                        0,15

               (1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC1.

               (2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2.

               (3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC3.

               (4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC4.

               (5)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC5.

               (6)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC6.


title: Commission Implementing Regulation (EU) 2018/1587 of 22 October 2018 revoking the designation of the Istituto Superiore di Sanità, Rome, Italy, as a European Reference Laboratory for the residues listed in Annex I, Group B(3)(c) to Council Directive 96/23/EC (Text with EEA relevance.)

text:
                  23.10.2018

                  EN

                  Official Journal of the European Union

                  L 264/20

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1587
         of 22 October 2018
         revoking the designation of the Istituto Superiore di Sanità, Rome, Italy, as a European Reference Laboratory for the residues listed in Annex I, Group B(3)(c) to Council Directive 96/23/EC
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) 2017/625 of the European Parliament and the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) 1107/2009, (EU) 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (1), and in particular Article 93(1) thereof,
         Whereas:

                     (1)

                     The Istituto Superiore di Sanità in Rome is listed in point 12(d) of Part I of Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council (2) as the designated European Union reference laboratory (‘EU reference laboratory’) for the residues listed in Annex I, Group B(3)(c) to Council Directive 96/23/EC (3).

                     (2)

                     Regulation (EU) 2017/625 repeals Regulation (EC) No 882/2004 and sets out new rules on official controls, including on the decision to establish and the designation of EU reference laboratories. Article 92(3) of Regulation (EU) 2017/625 provides that the Commission is to review regularly the mandate and the operation of EU reference laboratories.

                     (3)

                     As it was considered appropriate to merge the EU reference laboratory activities on chemical elements and nitrogenous compounds in food of plant and animal origin into one EU reference laboratory, by means of Commission Regulation (EU) 2018/192 (4), the National Food Institute, Technical University of Denmark in Copenhagen, Denmark was designated as an EU reference laboratory for metals and nitrogenous compounds in feed and food. As the activities of this EU reference laboratory overlap with the activities of the EU reference laboratory for the residues listed in Annex I, Group B(3)(c) to Directive 96/23/EC, currently two EU reference laboratories are responsible for the analysis of chemical elements in food of animal origin. Therefore the designation of the Istituto Superiore di Sanità in Rome as an EU reference laboratory for the residues listed in Annex I, Group B(3)(c) to Directive 96/23/EC should be revoked. Part I of Annex VII to Regulation (EC) No 882/2004 should be amended accordingly.

                     (4)

                     As the work program from 1 January 2018 until 31 December 2018 of the Istituto Superiore di Sanità in Rome was approved by the Commission and a grant was awarded for these activities, this Regulation should become applicable once this activity period has ended.

                     (5)

                     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 designation of the Istituto Superiore di Sanità in Rome as EU reference laboratory for the residues listed in Annex I, Group B(3)(c) to Directive 96/23/EC is revoked.
            Point 12(d) of Part I of Annex VII to Regulation (EC) No 882/2004 is deleted.

            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.
            It shall apply from 1 January 2019.

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 22 October 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 95, 7.4.2017, p. 1.

            (2)  Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).

            (3)  Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 23.5.1996, p. 10).

            (4)  Commission Regulation (EU) 2018/192 of 8 February 2018 amending Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the EU reference laboratories in the field of contaminants in feed and food (OJ L 36, 9.2.2018, p. 15).


title: Commission Implementing Regulation (EU) 2018/1621 of 26 October 2018 amending Implementing Regulation (EU) 2016/2080 as regards the date of entry into storage of the skimmed milk powder sold by a tendering procedure

text:
                  30.10.2018

                  EN

                  Official Journal of the European Union

                  L 271/25

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1621
         of 26 October 2018
         amending Implementing Regulation (EU) 2016/2080 as regards the date of entry into storage of the skimmed milk powder sold by a tendering procedure
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),
         Having regard to Commission Implementing Regulation (EU) 2016/1240 of 18 May 2016 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to public intervention and aid for private storage (2), and in particular Article 28 thereof,
         Whereas:

                     (1)

                     In order to define the quantities of skimmed milk powder covered by the tendering procedure opened by Commission Implementing Regulation (EU) 2016/2080 (3), Article 1 of that Regulation lays down a time limit before which the skimmed milk powder must have entered into public storage.

                     (2)

                     Given the current situation on the milk and milk products market in terms of price recovery and the high level of intervention stocks, it is appropriate that an additional volume of skimmed milk powder is made available for sale by changing the date of entry into storage.

                     (3)

                     Implementing Regulation (EU) 2016/2080 should therefore be amended accordingly.

                     (4)

                     In order to make the skimmed milk powder available for sale without delay, this Regulation should enter into force on the day after its publication in the Official Journal of the European Union.

                     (5)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            In Article 1 of Implementing Regulation (EU) 2016/2080, the date of ‘1 July 2016’ is replaced by ‘1 August 2016’.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 26 October 2018.

                  For the Commission,

                  On behalf of the President,

               Phil HOGAN

                  Member of the Commission

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

            (2)  OJ L 206, 30.7.2016, p. 71.

            (3)  Commission Implementing Regulation (EU) 2016/2080 of 25 November 2016 opening the sale of skimmed milk powder by a tendering procedure (OJ L 321, 29.11.2016, p. 45).


title: Commission Implementing Regulation (EU) 2018/1837 of 22 November 2018 on the minimum selling price for skimmed milk powder for the 28th partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2016/2080

text:
                  23.11.2018

                  EN

                  Official Journal of the European Union

                  L 298/10

         COMMISSION IMPLEMENTING REGULATION (EU) 2018/1837
         of 22 November 2018
         on the minimum selling price for skimmed milk powder for the 28th partial invitation to tender within the tendering procedure opened by Implementing Regulation (EU) 2016/2080
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1),
         Having regard to Commission Implementing Regulation (EU) 2016/1240 of 18 May 2016 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council with regard to public intervention and aid for private storage (2), and in particular Article 32 thereof,
         Whereas:

                     (1)

                     Commission Implementing Regulation (EU) 2016/2080 (3) has opened the sale of skimmed milk powder by a tendering procedure.

                     (2)

                     In the light of the tenders received for the 28th partial invitation to tender, a minimum selling price should be fixed.

                     (3)

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

               HAS ADOPTED THIS REGULATION:

            Article 1
            For the 28th partial invitation to tender for the selling of skimmed milk powder within the tendering procedure opened by Implementing Regulation (EU) 2016/2080, in respect of which the period during which tenders were to be submitted ended on 20 November 2018, the minimum selling price shall be 131,30 EUR/100 kg.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 22 November 2018.

                  For the Commission,

                  On behalf of the President,

               Jerzy PLEWA

                  Director-General

                  Directorate-General for Agriculture and Rural Development

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

            (2)  OJ L 206, 30.7.2016, p. 71.

            (3)  Commission Implementing Regulation (EU) 2016/2080 of 25 November 2016 opening the sale of skimmed milk powder by a tendering procedure (OJ L 321, 29.11.2016, p. 45).