title: Commission Implementing Regulation (EU) 2020/579 of 27 April 2020 granting a Union authorisation for the biocidal product family ‘HYPRED’s octanoic acid based products’ (Text with EEA relevance)

text:
                  28.4.2020

                  EN

                  Official Journal of the European Union

                  L 133/4

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/579
         of 27 April 2020
         granting a Union authorisation for the biocidal product family ‘HYPRED’s octanoic acid based products’
         (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 the first subparagraph of Article 44(5) thereof,
         Whereas:

                     (1)

                     On 25 August 2015, HYPRED SAS, submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘HYPRED‘s octanoic acid based products’ of product-type 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under the case number BC-LR019297-17 in the Register for Biocidal Products.

                     (2)

                     ‘HYPRED‘s octanoic acid based products’ contains octanoic acid, as the 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.

                     (3)

                     On 19 December 2017, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

                     (4)

                     On 11 July 2019, the Agency submitted to the Commission an opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘HYPRED‘s octanoic acid based products’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

                     (5)

                     The opinion concludes that ‘HYPRED‘s octanoic acid based products’ is a ‘biocidal product family’ within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

                     (6)

                     On 25 July 2019, 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.

                     (7)

                     The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘HYPRED‘s octanoic acid based products’.

                     (8)

                     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 with authorisation number EU-0021020-0000 is granted to HYPRED SAS for the making available on the market and use of the biocidal product family ‘HYPRED‘s octanoic acid based products’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
            The Union authorisation is valid from 18 May 2020 until 30 April 2030.

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

            This Regulation shall be binding in its entirety and directly applicable in all Member States.
            Done at Brussels, 27 April 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  ECHA opinion of 26 June 2019 on the Union authorisation of ‘HYPRED‘s octanoic acid based products’ (ECHA/BPC/226/2019), https://echa.europa.eu/bpc-opinions-on-union-authorisation.

            ANNEX
            Summary of product characteristics for a biocidal product family
            HYPRED‘s octanoic acid based products
            Product type 4 – Food and feed area (Disinfectants)
            Authorisation number: EU-0021020-0000
            R4BP asset number: EU-0021020-0000
            PART I

               FIRST INFORMATION LEVEL

            1.   ADMINISTRATIVE INFORMATION

            1.1.   Family name

                        Name

                        HYPRED‘s octanoic acid based products

                  1.2.   Product type(s)

                        Product type(s)

                        PT04 – Food and feed area (Disinfectants)

                  1.3.   Authorisation holder

                        Name and address of the authorisation holder

                        Name

                        HYPRED SAS

                        Address

                        55 boulevard Jules Verger, 35803 DINARD, France

                        Authorisation number

                        EU-0021020-0000

                           R4BP asset number

                        EU-0021020-0000

                        Date of the authorisation

                        18 May 2020

                        Expiry date of the authorisation

                        30 April 2030

                  1.4.   Manufacturer(s) of the biocidal products

                        Name of manufacturer

                        HYPRED SAS

                        Address of manufacturer

                        55 Boulevard Jules Verger, 35803 DINARD France

                        Location of manufacturing sites

                                    HYPRED SAS – 55 Boulevard Jules Verger – BP 10180, 35803 DINARD France

                                    HYPRED POLSKA SP. Z O.O. NIEPRUSZEWO, KASZTANOWA 4, 64320 buk Poland

                                    HYPRED IBERICA S.L Pol. Ind. Arazuri-Orcoyen C/C n° 32, 31160 Orcoyen – NAVARRA Spain

                                    HYPRED GmbH Marie-Curie-Straße 23, 53332 Bornheim – Sechtem Germany

                                    HYPRED Italia s.r.l. Strada Montodine-Gombito Loc. Cà Nova, 26010 Ripalta Arpina CR Italy

                                    AG France S.A.S – Zone Industrielle Le Roineau, 72500 Vaas France

                                    Anti-Germ Austria GmbH – ‘Pfongauer Straße 17, 5202 Neumarkt am Wallersee’ Austria

                                    Anti-Germ Deutschland GmbH – Oberbrühlstraße 16-18, 87700 Memmingen Germany

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

                        Active substance

                        Octanoic acid

                        Name of manufacturer

                        Emery Oleochemicals (M)

                        Address of manufacturer

                        Sdn Bhd (63112-D), Lot 4, Jalan Perak, Kawasan Perusahaan, 42500 Telok Panglima Garang, Selangor Malaysia

                        Location of manufacturing sites

                        Sdn Bhd (63112-D), Lot 4, Jalan Perak, Kawasan Perusahaan, 42500 Telok Panglima Garang, Selangor Malaysia

                  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

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        3,0

                        10,0

                        Methanesulfonic acid

                        Non-active substance

                        75-75-2

                        200-898-6

                        0,0

                        21,0

                        L-(+)-Lactic acid

                        Non-active substance

                        79-33-4

                        201-196-2

                        0,0

                        17,6

                        N,N-dimethyl-1-Decanamine, N-oxid

                        Non-active substance

                        2605-79-0

                        220-020-5

                        2,25

                        6,0

                        Ethoxylated alcohol

                        Ethoxylated alcohol

                        Non-active substance

                        31726-34-8

                        500-077-5

                        0,0

                        15,0

                  2.2.   Type(s) of formulation

                        Formulation(s)

                        SL – Soluble concentrate

                  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)

                        PT04 – Food and feed area (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

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        3,0

                        3,0

                        Methanesulfonic acid

                        Non-active substance

                        75-75-2

                        200-898-6

                        21,0

                        21,0

                        L-(+)-Lactic acid

                        Non-active substance

                        79-33-4

                        201-196-2

                        0,0

                        0,0

                        N,N-dimethyl-1-Decanamine, N-oxid

                        Non-active substance

                        2605-79-0

                        220-020-5

                        2,25

                        2,25

                        Ethoxylated alcohol

                        Ethoxylated alcohol

                        Non-active substance

                        31726-34-8

                        500-077-5

                        5,0

                        5,0

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

                        Formulation(s)

                        SL – Soluble concentrate

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

                        Hazard statements

                        May be corrosive to metals.
                        Causes severe skin burns and eye damage.
                        May cause respiratory irritation.
                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Wear protective gloves.
                        Wear protective clothing.
                        Wear eye protection.
                        Wear face protection.
                        IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
                        IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
                        IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
                        Immediately call a POISON CENTER.
                        Dispose of contents according to local/regional/national/international regulation.
                        Avoid release to the environment.

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

            4.1.   Use description

               Table 1. Use # 1 – Circulation in dairy industry

                        Product type

                        PT04 – Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts

                        Field(s) of use

                        Indoor
                        Cleaning – disinfection of circuits in dairy industry

                        Application method(s)

                        Closed system: Circulation
                        Clean-in-place (CIP), circulation

                        Application rate(s) and frequency

                        - Use 1 % product solution for bactericidal activity and 1,5 % product solution for yeasticidal activity
                        1 to 3 cycles per day, 208 to 360 days per year

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        Opaque jerrycan High-density polyethylene (HDPE) 5L
                        Opaque jerrycan HDPE 10L
                        Opaque jerrycan HDPE 22L
                        Opaque drum HDPE 60L
                        Opaque drum HDPE 120L
                        Opaque drum HDPE 220L
                        Opaque container HDPE 640L
                        Opaque container HDPE 1000L

                  4.1.1.   Use-specific instructions for use

            Rinse the circuits with drinking water before disinfection.
            Apply the product by circulation.
            Product concentration and contact time:

                        —

                        1 % bactericidal in 5 minutes

                        —

                        1,5 % yeasticidal in 15 minutes

                  Temperature of the product solution: 40 – 85 °C
            Rinse with drinking water.
            4.1.2.   Use-specific risk mitigation measures

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

            See general directions for use
            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
            4.2.   Use description

               Table 2. Use # 2 – Circulation in farms

                        Product type

                        PT04 – Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts

                        Field(s) of use

                        Indoor
                        Cleaning – disinfection of milking equipment and milking robots in farms

                        Application method(s)

                        Closed system: Circulation

                        Application rate(s) and frequency

                        - Use 0,8 % product solution for bactericidal activity and 1,5 % product solution for yeasticidal activity.
                        The milk installations cleaned and disinfected twice a day and the milk tank is cleaned and disinfected once every three days.

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        Opaque jerrycan HDPE 5L
                        Opaque jerrycan HDPE 10L
                        Opaque jerrycan HDPE 22L
                        Opaque drum HDPE 60L
                        Opaque drum HDPE 120L
                        Opaque drum HDPE 220L
                        Opaque container HDPE 640L
                        Opaque container HDPE 1000L

                  4.2.1.   Use-specific instructions for use

            Milk installations with or without a programmer.

                        (1)

                        After milking, rinse the equipment with warm drinking water.

                        (2)

                        Apply the solution by circulation at an initial recommended temperature of 60 °C minimum to achieve a final temperature of 40– 45 °C.

                  Product concentration and contact time:

                        0,8 % bactericidal in 10 minutes

                        1,5 % yeasticidal in 15 minutes

                  Do not use at temperature above 75 °C.

                        3)

                        Rinse with cold drinking water.

                  Use the product twice a day or once a day when alternating with another product.
            When alternating, use an alternative cleaner-disinfectant or a cleaning product 1 to 4 times per week depending on the temperature reached in the system.
            Contact your supplier for choosing the alternative product and the frequency of use.
            Do not mix the product with an alkaline or chlorinated alkaline product.
            4.2.2.   Use-specific risk mitigation measures

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

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

            5.1.   Instructions for use

            See use specific instructions for use.
            5.2.   Risk mitigation measures

                        —

                        Wear protective chemical resistant gloves, coverall and eye protection during product handling phase (protective material to be specified by the authorisation holder in the product information).

                        —

                        Ensure adequate ventilation during the application.

                  5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.
            FIRST AID

                        —

                        IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER or doctor/physician.

                        —

                        IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician.

                        —

                        IF IN EYES: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician.

                        —

                        IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician.

                  See Safety Data Sheets. They contain an emergency phone number
            When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.
            NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.
            NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!
            5.4.   Instructions for safe disposal of the product and its packaging

            Do not discharge the product directly to sewer or to the environment.
            Dispose the product and its packaging in accordance with applicable local and national regulations.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Shelf-life: 2 years in HDPE
            Conditions of storage: keep only in the original packaging. Keep container closed. Do not store at temperature above 40 °C.
            6.   OTHER INFORMATION

            The cleaning properties of the product has not been assessed as they are not covered by Regulation (EU) No 528/2012.
            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)

                        HYPRACID ONE
                        DEPTACID BD
                        prevides®MS

                        Authorisation number

                        EU-0021020-0001 1-1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        3,0

                        Methanesulfonic acid

                        Non-active substance

                        75-75-2

                        200-898-6

                        21,0

                        N,N-dimethyl-1-Decanamine, N-oxid

                        Non-active substance

                        2605-79-0

                        220-020-5

                        2,25

                        Ethoxylated alcohol

                        Ethoxylated alcohol

                        Non-active substance

                        31726-34-8

                        500-077-5

                        5,0

               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)

                        PT04 – Food and feed area (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

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        10,0

                        10,0

                        Methanesulfonic acid

                        Non-active substance

                        75-75-2

                        200-898-6

                        14,0

                        14,0

                        L-(+)-Lactic acid

                        Non-active substance

                        79-33-4

                        201-196-2

                        0,0

                        0,0

                        N,N-dimethyl-1-Decanamine, N-oxid

                        Non-active substance

                        2605-79-0

                        220-020-5

                        4,5

                        4,5

                        Ethoxylated alcohol

                        Ethoxylated alcohol

                        Non-active substance

                        31726-34-8

                        500-077-5

                        15,0

                        15,0

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

                        Formulation(s)

                        SL – Soluble concentrate

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

                        Hazard statements

                        May be corrosive to metals.
                        Harmful if swallowed.
                        Causes severe skin burns and eye damage.
                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Wear protective gloves.
                        Wear protective clothing.
                        Wear eye protection.
                        Wear face protection.
                        IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
                        IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
                        IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
                        Immediately call a POISON CENTER.
                        Dispose of contents according to local/regional/national/international regulation.
                        Avoid release to the environment.

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

            4.1.   Use description

               Table 3. Use # 1 – Circulation

                        Product type

                        PT04 – Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts

                        Field(s) of use

                        Indoor
                        Disinfection of circuits in breweries, dairy and beverage industries

                        Application method(s)

                        Closed system: Circulation
                        CIP, circulation

                        Application rate(s) and frequency

                        - Use 0,4 % product solution for bactericidal activity and 0,6 % product solution for yeasticidal activity.
                        1 to 3 cycles per day, 208 to 360 days per year

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        Opaque jerrycan HDPE 5L
                        Opaque jerrycan HDPE 10L
                        Opaque jerrycan HDPE 22L
                        Opaque drum HDPE 60L
                        Opaque drum HDPE 120L
                        Opaque drum HDPE 220L
                        Opaque container HDPE 640L
                        Opaque container HDPE 1000L

                  4.1.1.   Use-specific instructions for use

            See general directions for use
            4.1.2.   Use-specific risk mitigation measures

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

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

            5.1.   Instructions for use

            Prior to the application of the product, clean with a detergent and rinse with drinking water.
            Apply the product by circulation.
            Product concentration and contact time:

                        —

                        0,4 % bactericidal in 5 minutes

                        —

                        0,6 % yeasticidal in 15 minutes

                  Temperature of the product solution: 20 – 85 °C
            Rinse with drinking water.
            5.2.   Risk mitigation measures

                        —

                        Wear protective chemical resistant gloves, coverall and eye protection during product handling phase (protective material to be specified by the authorisation holder in the product information).

                        —

                        Ensure adequate ventilation during the application.

                  5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.
            FIRST AID

                        —

                        IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER or doctor/physician.

                        —

                        IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician.

                        —

                        IF IN EYES: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician.

                        —

                        IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician.

                  See Safety Data Sheets. They contain an emergency phone number.
            When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.
            NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.
            NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!
            5.4.   Instructions for safe disposal of the product and its packaging

            Do not discharge the product directly to sewer or to the environment.
            Dispose the product and its packaging in accordance with applicable local and national regulations.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Shelf-life: 2 years in HDPE
            Conditions of storage: keep only in the original packaging. Keep container closed. Keep in a cool place. Do not store at temperature above 40 °C.
            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)

                        DEPTACID CCB

                        Authorisation number

                        EU-0021020-0002 1-2

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        10,0

                        Methanesulfonic acid

                        Non-active substance

                        75-75-2

                        200-898-6

                        14,0

                        N,N-dimethyl-1-Decanamine, N-oxid

                        Non-active substance

                        2605-79-0

                        220-020-5

                        4,5

                        Ethoxylated alcohol

                        Ethoxylated alcohol

                        Non-active substance

                        31726-34-8

                        500-077-5

                        15,0

               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)

                        PT04 – Food and feed area (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

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        10,0

                        10,0

                        Methanesulfonic acid

                        Non-active substance

                        75-75-2

                        200-898-6

                        0,0

                        0,0

                        L-(+)-Lactic acid

                        Non-active substance

                        79-33-4

                        201-196-2

                        17,6

                        17,6

                        N,N-dimethyl-1-Decanamine, N-oxid

                        Non-active substance

                        2605-79-0

                        220-020-5

                        6,0

                        6,0

                        Ethoxylated alcohol

                        Ethoxylated alcohol

                        Non-active substance

                        31726-34-8

                        500-077-5

                        0,0

                        0,0

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

                        Formulation(s)

                        SL – Soluble concentrate

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

                        Hazard statements

                        May be corrosive to metals.
                        Causes severe skin burns and eye damage.
                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Wear protective gloves.
                        Wear protective clothing.
                        Wear eye protection.
                        Wear face protection.
                        IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
                        IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
                        IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
                        Immediately call a POISON CENTER.
                        Dispose of contents according to local/regional/national/international regulation.
                        Avoid release to the environment.

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

            4.1.   Use description

               Table 4. Use # 1 – Circulation

                        Product type

                        PT04 – Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts

                        Field(s) of use

                        Indoor
                        Disinfection of circuits in breweries, dairy and beverage industries

                        Application method(s)

                        Closed system: Circulation
                        CIP, circulation

                        Application rate(s) and frequency

                        - Use 0,4 % product solution
                        1 to 3 cycles per day, 208 to 360 days per year

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        Opaque jerrycan HDPE 5L
                        Opaque jerrycan HDPE 10L
                        Opaque jerrycan HDPE 22L
                        Opaque drum HDPE 60L
                        Opaque drum HDPE 120L
                        Opaque drum HDPE 220L
                        Opaque container HDPE 640L
                        Opaque container HDPE 1000L

                  4.1.1.   Use-specific instructions for use

            See general directions for use
            4.1.2.   Use-specific risk mitigation measures

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

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

            5.1.   Instructions for use

            Prior to the application of the product, clean with a detergent and rinse with drinking water.
            Apply the product by circulation.
            Product concentration: 0,4 %
            Contact time:

                        —

                        5 minutes for bactericidal activity

                        —

                        15 minutes for yeasticidal activity

                  Temperature of the product solution: 20 – 85 °C
            Rinse with drinking water.
            5.2.   Risk mitigation measures

                        —

                        Wear protective chemical resistant gloves, coverall and eye protection during product handling phase (protective material to be specified by the authorisation holder in the product information).

                        —

                        Ensure adequate ventilation during the application.

                  5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.
            FIRST AID

                        —

                        IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER or doctor/physician.

                        —

                        IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician.

                        —

                        IF IN EYES: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician.

                        —

                        IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician.

                  See Safety Data Sheets. They contain an emergency phone number.
            When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.
            NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.
            NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!
            5.4.   Instructions for safe disposal of the product and its packaging

            Do not discharge the product directly to sewer or to the environment.
            Dispose the product and its packaging in accordance with applicable local and national regulations.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Shelf-life: 2 years in HDPE
            Conditions of storage: keep only in the original packaging. Keep container closed. Do not store at temperature above 40 °C.
            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)

                        DEPTACID CB

                        Authorisation number

                        EU-0021020-0003 1-3

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        10,0

                        L-(+)-Lactic acid

                        Non-active substance

                        79-33-4

                        201-196-2

                        17,6

                        N,N-dimethyl-1-Decanamine, N-oxid

                        Non-active substance

                        2605-79-0

                        220-020-5

                        6,0

               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)

                        PT04 – Food and feed area (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

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        3,0

                        3,0

                        Methanesulfonic acid

                        Non-active substance

                        75-75-2

                        200-898-6

                        21,0

                        21,0

                        L-(+)-Lactic acid

                        Non-active substance

                        79-33-4

                        201-196-2

                        0,0

                        0,0

                        N,N-dimethyl-1-Decanamine, N-oxid

                        Non-active substance

                        2605-79-0

                        220-020-5

                        3,0

                        3,0

                        Ethoxylated alcohol

                        Ethoxylated alcohol

                        Non-active substance

                        31726-34-8

                        500-077-5

                        5,0

                        5,0

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

                        Formulation(s)

                        SL – Soluble concentrate

                  3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

                        Hazard statements

                        May be corrosive to metals.
                        Causes severe skin burns and eye damage.
                        May cause respiratory irritation.
                        Harmful to aquatic life with long lasting effects.

                        Precautionary statements

                        Wear protective gloves.
                        Wear protective clothing.
                        Wear eye protection.
                        Wear face protection.
                        IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
                        IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
                        IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
                        Immediately call a POISON CENTER.
                        Dispose of contents according to local/regional/national/international regulation.
                        Avoid release to the environment.

                  4.   AUTHORISED USE(S) OF THE META SPC 4

            4.1.   Use description

               Table 5. Use # 1 – Separative membranes circulation

                        Product type

                        PT04 – Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeasts

                        Field(s) of use

                        Indoor
                        Disinfectant or cleaner-disinfectant for membranes used in reverse osmosis and nanofiltration in dairy and beverage industries.

                        Application method(s)

                        Closed system: Circulation

                        Application rate(s) and frequency

                                    —

                                    Use 0,75 % product solution if cleaning is applied prior to the disinfection

                                    —

                                    Use 1 % product solution if no cleaning is applied prior to the disinfection

                              1 to 3 cycles per day, 104 to 312 days per year

                        Category(ies) of users

                        Professional

                        Pack sizes and packaging material

                        Opaque jerrycan HDPE 5L
                        Opaque jerrycan HDPE 10L
                        Opaque jerrycan HDPE 22L
                        Opaque drum HDPE 60L
                        Opaque drum HDPE 120L
                        Opaque drum HDPE 220L
                        Opaque container HDPE 640L
                        Opaque container HDPE 1000L

                  4.1.1.   Use-specific instructions for use

            See general directions for use
            4.1.2.   Use-specific risk mitigation measures

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

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

            5.1.   Instructions for use

            Rinse the membranes with drinking water or clean and rinse with drinking water before disinfection.
            Apply the product by circulation
            Product concentration if no cleaning is applied prior to the disinfection: 1 %
            Product concentration if cleaning is applied prior to the disinfection: 0,75 %
            Contact time:

                        —

                        5 minutes for bactericidal activity

                        —

                        15 minutes for yeasticidal activity

                  Temperature of the product solution: 40 – 85 °C
            Rinse with drinking water.
            5.2.   Risk mitigation measures

                        —

                        Wear protective chemical resistant gloves, coverall and eye protection during product handling phase (protective material to be specified by the authorisation holder in the product information).

                        —

                        Ensure adequate ventilation during the application.

                  5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.
            FIRST AID

                        —

                        IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER or doctor/physician.

                        —

                        IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/shower. Immediately call a POISON CENTER or doctor/physician.

                        —

                        IF IN EYES: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open. Remove contact lenses if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician.

                        —

                        IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. Immediately call a POISON CENTER or doctor/physician.

                  See Safety Data Sheets. They contain an emergency phone number
            When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.
            NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.
            NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!
            5.4.   Instructions for safe disposal of the product and its packaging

            Do not discharge the product directly to sewer or to the environment.
            Dispose the product and its packaging in accordance with applicable local and national regulations.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

            Shelf life: 2 years in HDPE
            Conditions of storage: keep only in the original packaging. Keep container closed. Do not store at temperature above 40 °C.
            6.   OTHER INFORMATION

            The cleaning properties of the product has not been assessed as they are not covered by Regulation (EU) No 528/2012.
            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)

                        DEPTACID WCM

                        Authorisation number

                        EU-0021020-0004 1-4

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        3,0

                        Methanesulfonic acid

                        Non-active substance

                        75-75-2

                        200-898-6

                        21,0

                        N,N-dimethyl-1-Decanamine, N-oxid

                        Non-active substance

                        2605-79-0

                        220-020-5

                        3,0

                        Ethoxylated alcohol

                        Ethoxylated alcohol

                        Non-active substance

                        31726-34-8

                        500-077-5

                        5,0

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

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

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

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