title: Commission Implementing Regulation (EU) 2020/580 of 27 April 2020 granting a Union authorisation for the biocidal product family ‘SOPURCLEAN’ (Text with EEA relevance)

text:
                  28.4.2020

                  EN

                  Official Journal of the European Union

                  L 133/23

         COMMISSION IMPLEMENTING REGULATION (EU) 2020/580
         of 27 April 2020
         granting a Union authorisation for the biocidal product family ‘SOPURCLEAN’
         (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 28 August 2015, SOPURA N.V., submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘SOPURCLEAN’ of product-type 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Belgium had agreed to evaluate the application. The application was recorded under the case number BC-PJ019489-22 in the Register for Biocidal Products.

                     (2)

                     ‘SOPURCLEAN’ contains octanoic acid and decanoic acid, as the active substances, which are included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.

                     (3)

                     On 15 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 15 July 2019, the Agency submitted to the Commission an opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘SOPURCLEAN’ 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 ‘SOPURCLEAN’ 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 26 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 ‘SOPURCLEAN’.

                     (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-0021157-0000 is granted to SOPURA N.V. for the making available on the market and use of the biocidal product family ‘SOPURCLEAN’ 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 ‘SOPURCLEAN’ (ECHA/BPC/227/2019), https://echa.europa.eu/bpc-opinions-on-union-authorisation.

            ANNEX
            Summary of product characteristics for a biocidal product family
            SOPURCLEAN
            Product type 4 – Food and feed area (Disinfectants)
            Authorisation number: EU-0021157-0000
            R4BP asset number: EU-0021157-0000
            PART I

               FIRST INFORMATION LEVEL

            1.   ADMINISTRATIVE INFORMATION

            1.1.   Family name

                        Name

                        SOPURCLEAN

                  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

                        SOPURA N.V.

                        Address

                        Rue de Trazegnies 199, 6180 COURCELLES, Belgium

                        Authorisation number

                        EU-0021157-0000

                           R4BP asset number

                        EU-0021157-0000

                        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

                        SOPURA N.V.

                        Address of manufacturer

                        Rue de Trazegnies 199, 6180 COURCELLES Belgium

                        Location of manufacturing sites

                        PIB de Tyberchamps 14, 7180 SENEFFE Belgium
                        Rue de Trazegnies 199, 6180 COURCELLES Belgium

                        Name of manufacturer

                        SOPURA QUIMICA

                        Address of manufacturer

                        Poligon ‘La Canaleta’, Avinguda Júpiter 9, 25300 TARREGA Spain

                        Location of manufacturing sites

                        Poligon ‘La Canaleta’, Avinguda Júpiter 9, 25300 TARREGA Spain

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

                        Active substance

                        Octanoic acid

                        Name of manufacturer

                        Emery Oleochemicals (M) Sdn Bhd (63112-D)

                        Address of manufacturer

                        Lot 4, Jalan Perak, Kawasan Perusahaan, Telok Panglima Garang, 42500 Selangor Malaysia

                        Location of manufacturing sites

                        Lot 4, Jalan Perak, Kawasan Perusahaan, Telok Panglima Garang, 42500 Selangor Malaysia

                        Active substance

                        Decanoic acid

                        Name of manufacturer

                        Emery Oleochemicals (M) Sdn Bhd (63112-D)

                        Address of manufacturer

                        Lot 4, Jalan Perak, Kawasan Perusahaan, Telok Panglima Garang, 42500 Selangor Malaysia

                        Location of manufacturing sites

                        Lot 4, Jalan Perak, Kawasan Perusahaan, Telok Panglima Garang, 42500 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

                        1,1

                        2,7

                        Decanoic acid

                        Active Substance

                        334-48-5

                        206-376-4

                        0,3

                        1,5

                        Sulfuric acid

                        Non-active substance

                        7664-93-9

                        231-639-5

                        0,0

                        31,2

                        Propionic acid

                        Non-active substance

                        79-09-4

                        201-176-3

                        0,0

                        19,5

                        Phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        0,0

                        30,0

                        Nitric acid

                        Non-active substance

                        7697-37-2

                        231-714-2

                        0,0

                        18,0

                        Methane sulfonic acid

                        Non-active substance

                        75-75-2

                        200-898-6

                        0,0

                        20,3

                        Glycolic acid

                        Non-active substance

                        79-14-1

                        201-180-5

                        0,0

                        4,2

                        Lactic acid

                        Non-active substance

                        79-33-4

                        201-196-2

                        0,0

                        35,2

                        Citric acid

                        Non-active substance

                        77-92-9

                        201-069-1

                        0,0

                        3,0

                  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

                        1,1

                        1,8

                        Decanoic acid

                        Active Substance

                        334-48-5

                        206-376-4

                        0,75

                        1,5

                        Sulfuric acid

                        Non-active substance

                        7664-93-9

                        231-639-5

                        0,0

                        31,2

                        Propionic acid

                        Non-active substance

                        79-09-4

                        201-176-3

                        0,0

                        0,0

                        Phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        0,0

                        30,0

                        Nitric acid

                        Non-active substance

                        7697-37-2

                        231-714-2

                        0,0

                        0,0

                        Methane sulfonic acid

                        Non-active substance

                        75-75-2

                        200-898-6

                        0,0

                        12,6

                        Glycolic acid

                        Non-active substance

                        79-14-1

                        201-180-5

                        0,0

                        4,2

                        Lactic acid

                        Non-active substance

                        79-33-4

                        201-196-2

                        0,0

                        0,0

                        Citric acid

                        Non-active substance

                        77-92-9

                        201-069-1

                        0,0

                        3,0

                  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.

                        Precautionary statements

                        Do not breathe vapours.
                        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.
                        Immediately call a doctor.
                        Wear eye protection.
                        Wear face protection.
                        Wear protective clothing.
                        Wear protective gloves.
                        IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
                        IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water (or shower).
                        Keep only in original container.
                        Store in a well-ventilated place.Keep container tightly closed.
                        Absorb spillage to prevent material damage.
                        Dispose of contents in accordance with local/regional/national/international regulations.

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

            4.1.   Use description

               Table 1

               Use # 1 – Cleaning in place (CIP) with 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
                        In food and feed areas

                        Application method(s)

                        Closed system
                        For disinfection of pipes, tanks, and other parts of the closed system:

                                    —

                                    Biocidal product (semi-)automatically dosed in the CIP vessel (either by volume or conductivity measurements)

                                    —

                                    Circulation in a closed CIP system

                        Application rate(s) and frequency

                                    —

                                    For an effect on bacteria and yeasts: Dilution rate: 1,5 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 2 % v/v. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

                              -

                        Category(ies) of users

                        Industrial
                        Trained professional

                        Pack sizes and packaging material

                                    •

                                    Jerrycan High-density polyethylene (PE-HD), containing: 10 to 12,5 kg (*1).

                                    •

                                    Jerrycan (PE-HD), containing: 20 to 25 kg (*1).

                                    •

                                    Drums (PE-HD) containing 200 to 250 kg (*1).

                                    •

                                    Containers (PE-HD) containing 600 to 750 kg (*1).

                                    •

                                    Intermediate bulk containers (IBC, PE-HD) containing 1 100  to 1 250  kg (*1)

                                    •

                                    Bulk delivery.

                  4.1.1.   Use-specific instructions for use

            In case of re-use of the disinfectant solution for CIP procedures, the active substance concentration must be measured and restored to its intended level before re-use.
            4.1.2.   Use-specific risk mitigation measures

               During the mixing, loading and application phases:

                        —

                        Transfer in closed systems and industrial risk mitigation measures (RMM) excluding risk for skin and eye exposure (containers containing the product are connected to CIP via installed pipes; connections with dry coupling).

                        —

                        Treated equipment (vessels) and dosing equipment has to be rinsed with drinking water after 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 – Dipping/soaking

                        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
                        In food and feed areas

                        Application method(s)

                        Open system: immersion
                        For disinfection of small hard non-porous parts (e.g. spare parts, tools, valves, hoses) used in the food manufacturing process:

                                    —

                                    Concentrated product pumped in the bath and tap water added to reach the required concentration

                                    —

                                    Immersion

                        Application rate(s) and frequency

                                    —

                                    For an effect on bacteria and on yeasts: Dilution rate: 1,5 %v/v In case of outbreaks of Pediococcus damnosus, the products must be used at 2 % v/v. Contact time: minimum 15 minutes at +4 °C and above, up to 20– 25 °C.

                              -

                        Category(ies) of users

                        Industrial
                        Trained professional

                        Pack sizes and packaging material

                                    •

                                    Jerrycan (PE-HD), containing: 10 to 12,5 kg (*2).

                                    •

                                    Jerrycan (PE-HD), containing: 20 to 25 kg (*2).

                                    •

                                    Drums (PE-HD) containing 200 to 250 kg (*2).

                                    •

                                    Containers (PE-HD) containing 600 to 750 kg (*2).

                                    •

                                    IBC (PE-HD) containing 1 100  to 1 250  kg (*2)

                                    •

                                    Bulk delivery.

                  4.2.1.   Use-specific instructions for use

            The dipping solution must be replaced by a fresh solution when it becomes visually polluted, and in all cases daily.
            4.2.2.   Use-specific risk mitigation measures

               During the post application phase:

            Rinse the equipment with drinking water.
            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

               For an effect on bacteria and on yeasts

                        •

                        Rinsing and cleaning before disinfection:

                  Not mandatory (even if a pre-rinsing is always recommended and usually performed by the users). For disinfection procedures in slaughterhouses, cleaning with a cold alkaline solution) is mandatory before disinfection.

                        •

                        Disinfecting cycle:

                                    —

                                    Dilution of the concentrated product in tap water before use: 1,5 %

                              In case of outbreaks of Pediococcus damnosus, the product must be used at 2 %.

                                    —

                                    Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

                        •

                        Final rinsing with drinking water

                  5.2.   Risk mitigation measures

            Use in well-ventilated places.
            During the mixing, loading and application phases: wear a protective coverall. Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information). Use eye protection during handling of the product. Wear face protection.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Particulars of likely direct or indirect adverse effects:

                        •

                        Severe chemical burns and/or corrosion of the eyes, mucosae, respiratory and digestive tract with the risk of perforation and intense pain. Absence of visual oral burns does not exclude esophageal burns.

                        •

                        If aspiration and/or ingestion occurs this may induce chemical pneumonia and metabolic acidosis.

                  First aid instructions:

                        •

                        Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles.

                        •

                        In case of inhalation: Remove to fresh air. Allow the affected person to rest. Not expected to require first aid measures.

                        •

                        In case of eye exposure: Seek medical attention immediately. ALWAYS check for and remove contact lenses. Rinse immediately with plenty of water during 15 minutes and keep the eyelids open. Keep a bottle of water at hand.

                        •

                        In case of skin contact: Obtain medical attention. Remove contaminated clothing and shoes. Wash affected area with plenty of water. NO scrubbing.

                        •

                        In case of mouth contact or ingestion: Do NOT induce vomiting, if the individual is conscious, able to swallow saliva without coughing and ingestion occurred in less than one hour proceed to mouth wash with plenty of water. Take to hospital.

                        •

                        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.

                        •

                        Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration.

                        •

                        If symptoms persist or worsen bring individual to a healthcare center, bring packaging or label whenever possible.

                        •

                        NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

                  Advice for medical and healthcare personnel:

                        •

                        In case of ingestion consider performing an endoscopic procedure.

                        •

                        The use of ipecac syrup, neutralization and activated charcoal is not advised.

                        •

                        Symptomatic and supportive treatment.

                        •

                        WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTER

                  Emergency measures to protect the environment:

                        •

                        Prevent entry into sewers and public waters.

                        •

                        Clean up any spills as soon as possible, using an absorbent material (e.g. earth, sand) to collect the spill. Use suitable disposal containers.

                  5.4.   Instructions for safe disposal of the product and its packaging

            Keep only in the original packaging tightly closed in a cool and well-ventilated place
            Keep the product away from direct sunlight, source of heat and ignition.
            The product must be stored at temperatures below +30 °C.
            Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) nor down the drains.
            Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

               Storage conditions:

                        •

                        Store in a clean area allowing recuperation of leaks and effusion.

                        •

                        Protect from freezing. Provide local exhaust or general room ventilation to minimize dust and/or vapour concentrations. Keep container closed when not in use.

                        •

                        Handle in accordance with good industrial hygiene and safety procedures.

                  Packaging material: Use approved materials suitable for corrosive liquids.

               Shelf-life: 12 months in the original packaging.
            6.   OTHER INFORMATION

            Any product in meta SPC1 shall contain sufficient amounts of acids to yield a pH ≤ 2 at the dilution of 1,5 %.
            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)

                        SEPTACID BN

                        Authorisation number

                        EU-0021157-0001 1-1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        1,5

                        Decanoic acid

                        Active Substance

                        334-48-5

                        206-376-4

                        1,5

                        Sulfuric acid

                        Non-active substance

                        7664-93-9

                        231-639-5

                        31,2

                        Glycolic acid

                        Non-active substance

                        79-14-1

                        201-180-5

                        4,2

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

                        Trade name(s)

                        SEPTACID BN PS

                        Authorisation number

                        EU-0021157-0002 1-1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        1,5

                        Decanoic acid

                        Active Substance

                        334-48-5

                        206-376-4

                        1,5

                        Phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        30,0

                        Glycolic acid

                        Non-active substance

                        79-14-1

                        201-180-5

                        4,2

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

                        Trade name(s)

                        SOPURCIP EC

                        Authorisation number

                        EU-0021157-0003 1-1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        1,1

                        Decanoic acid

                        Active Substance

                        334-48-5

                        206-376-4

                        0,75

                        Sulfuric acid

                        Non-active substance

                        7664-93-9

                        231-639-5

                        7,8

                        Methane sulfonic acid

                        Non-active substance

                        75-75-2

                        200-898-6

                        12,6

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

                        Trade name(s)

                        SOPURCLEAN BN

                        Authorisation number

                        EU-0021157-0004 1-1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        1,8

                        Decanoic acid

                        Active Substance

                        334-48-5

                        206-376-4

                        1,2

                        Sulfuric acid

                        Non-active substance

                        7664-93-9

                        231-639-5

                        29,64

                        Citric acid

                        Non-active substance

                        77-92-9

                        201-069-1

                        3,0

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

                        Trade name(s)

                        SOPURCLEAN BN PS

                        Authorisation number

                        EU-0021157-0005 1-1

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        1,8

                        Decanoic acid

                        Active Substance

                        334-48-5

                        206-376-4

                        1,2

                        Phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        30,0

                        Citric acid

                        Non-active substance

                        77-92-9

                        201-069-1

                        2,5

               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

                        2,7

                        2,7

                        Decanoic acid

                        Active Substance

                        334-48-5

                        206-376-4

                        0,3

                        0,3

                        Sulfuric acid

                        Non-active substance

                        7664-93-9

                        231-639-5

                        0,0

                        0,0

                        Propionic acid

                        Non-active substance

                        79-09-4

                        201-176-3

                        19,5

                        19,5

                        Phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        3,8

                        3,8

                        Nitric acid

                        Non-active substance

                        7697-37-2

                        231-714-2

                        0,0

                        0,0

                        Methane sulfonic acid

                        Non-active substance

                        75-75-2

                        200-898-6

                        0,0

                        0,0

                        Glycolic acid

                        Non-active substance

                        79-14-1

                        201-180-5

                        0,0

                        0,0

                        Lactic acid

                        Non-active substance

                        79-33-4

                        201-196-2

                        35,2

                        35,2

                        Citric acid

                        Non-active substance

                        77-92-9

                        201-069-1

                        0,0

                        0,0

                  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.
                        Causes severe skin burns and eye damage.
                        May cause respiratory irritation.

                        Precautionary statements

                        Do not breathe vapours.
                        Wear protective gloves.
                        Wear protective clothing.
                        Wear eye protection.
                        Wear face protection.
                        IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water (or shower).
                        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.
                        Immediately call a doctor.
                        Keep only in original container.
                        Store in a well-ventilated place.Keep container tightly closed.
                        IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
                        Dispose of contents in accordance with local/regional/national/international regulations.

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

            4.1.   Use description

               Table 3

               Use # 1 – Cleaning in place (CIP) with 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
                        In food and feed areas

                        Application method(s)

                        Closed system
                        For disinfection of pipes, tanks, and other parts of the closed system:

                                    —

                                    Biocidal product (semi-)automatically dosed in the CIP vessel (either by volume or conductivity measurements)

                                    —

                                    Circulation in a closed CIP system

                        Application rate(s) and frequency

                        - - For an effect on bacteria and on yeasts: Dilution rate: 1 %v/v In case of outbreaks of Pediococcus damnosus, the product must be used at 1,5 % v/v. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.
                        -

                        Category(ies) of users

                        Industrial
                        Trained professional

                        Pack sizes and packaging material

                                    •

                                    Jerrycan (PE-HD), containing: 10 to 12,5 kg (*3).

                                    •

                                    Jerrycan (PE-HD), containing: 20 to 25 kg (*3).

                                    •

                                    Drums (PE-HD) containing 200 to 250 kg (*3).

                                                •

                                                Containers (PE-HD) containing 600 to 750 kg (*3)

                                                •

                                                IBC (PE-HD) containing 1 100  to 1 250  kg (*3)

                                    •

                                    Bulk delivery.

                  4.1.1.   Use-specific instructions for use

            In case of re-use of the disinfectant solution for CIP procedures, the active substance concentration must be measured and restored to its intended level before re-use.
            4.1.2.   Use-specific risk mitigation measures

               During the mixing, loading and application phases:

                        —

                        Transfer in closed systems and industrial RMM excluding risk for skin and eye exposure.IBC containers containing the product are connected to CIP via installed pipes; connections are made with dry coupling.

                  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 4

               Use # 2 – Spraying

                        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
                        In food and feed areas

                        Application method(s)

                        Spraying
                        For disinfection of hard non-porous surfaces in contact with food processing:

                                    —

                                    Diluted biocidal product sprayed via a low pressure spraying device

                        Application rate(s) and frequency

                        Maximum application rate: 100 mL/m2 – For an effect on bacteria and on yeasts: Dilution rate: 1 %v/v. In case of outbreaks of Pediococcus damnosus, the product must be used at 1,5 %. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.
                        -

                        Category(ies) of users

                        Industrial
                        Trained professional

                        Pack sizes and packaging material

                        Jerrycan (PE-HD), containing: 10 to 12,5 kg (*4).

                                    •

                                    Jerrycan (PE-HD), containing: 20 to 25 kg (*4).

                                    •

                                    Drums (PE-HD) containing 200 to 250 kg (*4).

                                                •

                                                Containers (PE-HD) containing 600 to 750 kg. (*4)

                                    •

                                    IBC (PE-HD) containing 1 100  to 1 250  kg (*4)

                                    •

                                    Bulk delivery.

                  4.2.1.   Use-specific instructions for use

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

            Fully automated process where workers are not present during spraying.
            Workers only re-enter in the work area when spraying solution has been drained.
            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.
            4.3.   Use description

               Table 5

               Use # 3 – Manual disinfection

                        Product type

                        PT04 – Food and feed area (Disinfectants)

                        Where relevant, an exact description of the authorised use

                        -

                        Target organism(s) (including development stage)

                        Bacteria
                        Yeast

                        Field(s) of use

                        Indoor
                        In food and feed areas

                        Application method(s)

                        Manual application
                        For disinfection of hard non-porous small parts and surfaces used in the food manufacturing process:

                                    —

                                    Diluted product sprayed via a low pressure spraying device

                                    —

                                    After the optimal contact time for disinfection, the small parts are to be wiped or mopped or brushed.

                        Application rate(s) and frequency

                        Maximum application rate: 100 mL/m2 – For an effect on bacteria and on yeasts: Dilution rate: 1 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 1,5 %. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.
                        -

                        Category(ies) of users

                        Industrial
                        Trained professional

                        Pack sizes and packaging material

                        Jerrycan (PE-HD), containing: 10 to 12,5 kg (*5).

                                    •

                                    Jerrycan (PE-HD), containing: 20 to 25 kg (*5).

                                    •

                                    Drums (PE-HD) containing 200 to 250 kg (*5).

                                                •

                                                Containers (PE-HD) containing 600 to 750 kg (*5).

                                    •

                                    IBC (PE-HD) containing 1 100  to 1 250  kg (*5)

                                    •

                                    Bulk delivery.

                  4.3.1.   Use-specific instructions for use

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

            See general directions for use.
            4.3.3.   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.
            4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use.
            4.3.5.   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.
            4.4.   Use description

               Table 6

               Use # 4 – Dipping/soaking

                        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
                        In food and feed areas

                        Application method(s)

                        Open system: immersion
                        For disinfection of hard non-porous small parts (e.g. spare parts, tools, valves, hoses) used in the food manufacturing process:

                                    —

                                    Concentrated product pumped in the bath and tap water added to reach the required concentration

                                    —

                                    Immersion

                        Application rate(s) and frequency

                                    —

                                    For an effect on bacteria and on yeasts: Dilution rate: 1 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 1,5 %. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

                              -

                        Category(ies) of users

                        Industrial
                        Trained professional

                        Pack sizes and packaging material

                        Jerrycan (PE-HD), containing: 10 to 12,5 kg (*6).
                        Jerrycan (PE-HD), containing: 20 to 25 kg (*6).
                        Drums (PE-HD) containing 200 to 250 kg (*6).
                        Containers (PE-HD) containing 600 to 750 kg (*6).
                        IBC (Internal bulk containers, PE-HD) containing 1 100  to 1 250  kg (*6)

                        Bulk delivery.

                  4.4.1.   Use-specific instructions for use

            The dipping solution must be replaced by a fresh solution when it becomes visually polluted, and in all cases daily.
            4.4.2.   Use-specific risk mitigation measures

            See general directions for use.
            4.4.3.   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.
            4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

            See general directions for use.
            4.4.5.   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

               For an effect on bacteria and on yeasts

                        •

                        Rinsing and cleaning before disinfection: Not mandatory (even if a pre-rinsing is always recommended and usually performed by the users).

                  For disinfection procedures in slaughterhouses, cleaning with a cold alkaline solutionis mandatory before disinfection.

                        •

                        Disinfecting cycle:

                                    —

                                    Dilution of the concentrated product in tap water before use: 1,0 %. In case of outbreaks of Pediococcus damnosus, the products must be used at 1,5 %.

                                    —

                                    Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

                                    —

                                    Disinfection via spraying/manual disinfection: Make sure to wet surfaces completely.

                        •

                        Final rinsing: not necessary

                  5.2.   Risk mitigation measures

            During the mixing and loading and application phases: wear a protective coverall. Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information). Use of eye protection during handling of the product. Wear face protection.
            Use in well ventilated places.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Particulars of likely direct or indirect adverse effects:

                        •

                        Severe chemical burns and/or corrosion of the eyes, mucosae, respiratory and digestive tract with the risk of perforation and intense pain. Absence of visual oral burns does not exclude esophageal burns.

                        •

                        If aspiration and/or ingestion occurs this may induce chemical pneumonia and metabolic acidosis.

                  First aid instructions:

                        •

                        Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles.

                        •

                        In case of inhalation: Remove to fresh air. Allow the affected person to rest. Not expected to require first aid measures.

                        •

                        In case of eye exposure: Seek medical attention immediately. ALWAYS check for and remove contact lenses. Rinse immediately with plenty of water during 15 minutes and keep the eyelids open. Keep a bottle of water at hand.

                        •

                        In case of skin contact: Obtain medical attention. Remove contaminated clothing and shoes. Wash affected area with plenty of water. NO scrubbing.

                        •

                        In case of mouth contact or ingestion: Do NOT induce vomiting, if the individual is conscious, able to swallow saliva without coughing and ingestion occurred in less than one hour proceed to mouth wash with plenty of water. Take to hospital.

                        •

                        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.

                        •

                        Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration.

                        •

                        If symptoms persist or worsen bring individual to a healthcare center, bring packaging or label whenever possible.

                        •

                        NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

                  Advice for medical and healthcare personnel:

                        •

                        In case of ingestion consider performing an endoscopic procedure.

                        •

                        The use of ipecac syrup, neutralization and activated charcoal is not advised.

                        •

                        Symptomatic and supportive treatment.

                        •

                        WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTER

                  Emergency measures to protect the environment:

                        •

                        Prevent entry into sewers and public waters.

                        •

                        Clean up any spills as soon as possible, using an absorbent material (earth, sand, ...) to collect the spill. Use suitable disposal containers.

                  5.4.   Instructions for safe disposal of the product and its packaging

            Keep only in the original packaging tightly closed in a cool and well-ventilated place
            Keep the product away from direct sunlight, source of heat and ignition.
            The product must be stored at temperatures below +30 °C.
            Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) nor down the drains
            Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

               Storage conditions:

                        •

                        Store in a clean area allowing recuperation of leaks and effusion.

                        •

                        Protect from freezing. Provide local exhaust or general room ventilation to minimize dust and/or vapour concentrations. Keep packaging closed when not in use.

                        •

                        Handle in accordance with good industrial hygiene and safety procedures.

                  Packaging material: Use approved materials suitable for corrosive liquids.

               Shelf-life: 12 months in the original packaging.
            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)

                        SOPURCLEAN NR

                        Authorisation number

                        EU-0021157-0006 1-2

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        2,7

                        Decanoic acid

                        Active Substance

                        334-48-5

                        206-376-4

                        0,3

                        Propionic acid

                        Non-active substance

                        79-09-4

                        201-176-3

                        19,5

                        Phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        3,8

                        Lactic acid

                        Non-active substance

                        79-33-4

                        201-196-2

                        35,2

               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

                        1,8

                        1,8

                        Decanoic acid

                        Active Substance

                        334-48-5

                        206-376-4

                        1,2

                        1,2

                        Sulfuric acid

                        Non-active substance

                        7664-93-9

                        231-639-5

                        0,0

                        0,0

                        Propionic acid

                        Non-active substance

                        79-09-4

                        201-176-3

                        0,0

                        0,0

                        Phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        0,0

                        0,0

                        Nitric acid

                        Non-active substance

                        7697-37-2

                        231-714-2

                        18,0

                        18,0

                        Methane sulfonic acid

                        Non-active substance

                        75-75-2

                        200-898-6

                        0,0

                        0,0

                        Glycolic acid

                        Non-active substance

                        79-14-1

                        201-180-5

                        0,0

                        0,0

                        Lactic acid

                        Non-active substance

                        79-33-4

                        201-196-2

                        0,0

                        0,0

                        Citric acid

                        Non-active substance

                        77-92-9

                        201-069-1

                        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 if inhaled.

                        Precautionary statements

                        Do not breathe vapours.
                        Wear protective clothing.
                        Wear eye protection.
                        Wear protective gloves.
                        Wear face protection.
                        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 doctor.
                        Immediately call a POISON CENTER.
                        Keep only in original container.
                        IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
                        Store in a well-ventilated place.Keep container tightly closed.
                        Absorb spillage to prevent material damage.
                        Dispose of contents in accordance with local/regional/national/international regulations.

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

            4.1.   Use description

               Table 7

               Use # 1 – Cleaning in place (CIP) with 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
                        In food and feed areas

                        Application method(s)

                        Closed system
                        For disinfection of pipes, tanks, and other parts of the closed system.

                                    —

                                    Biocidal product (semi-)automatically dosed in the CIP vessel (either by volume or conductivity measurements)

                                    —

                                    Circulation in a closed CIP system

                        Application rate(s) and frequency

                                    —

                                    For an effect on bacteria and on yeasts: Dilution rate: 1,5 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 2 % v/v. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

                              -

                        Category(ies) of users

                        Industrial
                        Trained professional

                        Pack sizes and packaging material

                                    •

                                    Jerrycan (PE-HD), containing: 10 to 12,5 kg (*7).

                                    •

                                    Jerrycan (PE-HD), containing: 20 to 25 kg (*7).

                                    •

                                    Drums (PE-HD) containing 200 to 250 kg (*7).

                                    •

                                    Containers (PE-HD) containing 600 to 750 kg (*7).

                                    •

                                    IBC (PE-HD) containing 1 100  to 1 250  kg (*7)

                                    •

                                    Bulk delivery.

                  4.1.1.   Use-specific instructions for use

            In case of re-use of the disinfectant solution for CIP procedures, the active substance concentration must be measured and restored to its intended level before re-use.
            4.1.2.   Use-specific risk mitigation measures

            During the mixing, loading and application phases:

                        —

                        Transfer in closed systems and industrial RMM excluding risk for skin and eye exposure. (Containers containing the product are connected to CIP via installed pipes; connections are made with dry coupling.

                  During the mixing and loading phases:

                        —

                        Wear respiratory mask.

                  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

               For an effect on bacteria and on yeasts

                        •

                        Rinsing and cleaning before disinfection:

                  Not mandatory (even if a pre-rinsing is always recommended and usually performed by the users).
            For disinfection procedures in slaughterhouses, cleaning with a cold alkaline solution is mandatory before disinfection.

                        •

                        Disinfecting cycle:

                                    —

                                    Dilution of the concentrated product in tap water before use: 1,5 %

                              In case of outbreaks of Pediococcus damnosus, the product must be used at 2 %.

                                    —

                                    Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

                        •

                        Final rinsing with drinking water

                  5.2.   Risk mitigation measures

            Use in well-ventilated places.
            During the mixing, loading and application phases:
            Wear a protective coverall. Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information). Use of eye protection during handling of the product. Wear face protection.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Particulars of likely direct or indirect adverse effects:

                        •

                        Severe chemical burns and/or corrosion of the eyes, mucosae, respiratory and digestive tract with the risk of perforation and intense pain. Absence of visual oral burns does not exclude esophageal burns.

                        •

                        If aspiration and/or ingestion occurs this may induce chemical pneumonia and metabolic acidosis.

                  First aid instructions:

                        •

                        Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles.

                        •

                        In case of inhalation: Remove to fresh air. Allow the affected person to rest. Not expected to require first aid measures.

                        •

                        In case of eye exposure: Seek medical attention immediately. ALWAYS check for and remove contact lenses. Rinse immediately with plenty of water during 15 minutes and keep the eyelids open. (Keep a bottle of water at hand).

                        •

                        In case of skin contact: Obtain medical attention. Remove contaminated clothing and shoes. Wash affected area with plenty of water. NO scrubbing.

                        •

                        In case of mouth contact or ingestion: Do NOT induce vomiting, if the individual is conscious, able to swallow saliva without coughing and ingestion occurred in less than one hour proceed to mouth wash with plenty of water. Take to hospital.

                        •

                        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.

                        •

                        Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration.

                        •

                        If symptoms persist or worsen bring individual to a healthcare center, bring packaging or label whenever possible.

                        •

                        NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

                  Advice for medical and healthcare personnel:

                        •

                        In case of ingestion consider performing an endoscopic procedure.

                        •

                        The use of ipecac syrup, neutralization and activated charcoal is not advised.

                        •

                        Symptomatic and supportive treatment.

                        •

                        WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTER

                  Emergency measures to protect the environment:

                        •

                        Prevent entry into sewers and public waters.

                        •

                        Clean up any spills as soon as possible, using an absorbent material (e.g. earth, sand) to collect the spill. Use suitable disposal containers.

                  5.4.   Instructions for safe disposal of the product and its packaging

            Keep only in the original packaging tightly closed in a cool and well-ventilated place
            Keep the product away from direct sunlight, source of heat and ignition.
            The product must be stored at temperatures below +30 °C.
            Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains
            Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

               Storage conditions:

                        •

                        Store in a clean area allowing recuperation of leaks and effusion.

                        •

                        Protect from freezing. Provide local exhaust or general room ventilation to minimize dust and/or vapour concentrations. Keep packaging closed when not in use.

                        •

                        Handle in accordance with good industrial hygiene and safety procedures.

                  Packaging material: Use approved materials suitable for corrosive liquids.

               Shelf-life: 12 months in the original packaging.
            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)

                        SOPURCLEAN OP-N

                        Authorisation number

                        EU-0021157-0007 1-3

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        1,8

                        Decanoic acid

                        Active Substance

                        334-48-5

                        206-376-4

                        1,2

                        Nitric acid

                        Non-active substance

                        7697-37-2

                        231-714-2

                        18,0

               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

                        1,8

                        1,8

                        Decanoic acid

                        Active Substance

                        334-48-5

                        206-376-4

                        1,2

                        1,2

                        Sulfuric acid

                        Non-active substance

                        7664-93-9

                        231-639-5

                        4,68

                        4,68

                        Propionic acid

                        Non-active substance

                        79-09-4

                        201-176-3

                        0,0

                        0,0

                        Phosphoric acid

                        Non-active substance

                        7664-38-2

                        231-633-2

                        0,0

                        0,0

                        Nitric acid

                        Non-active substance

                        7697-37-2

                        231-714-2

                        0,0

                        0,0

                        Methane sulfonic acid

                        Non-active substance

                        75-75-2

                        200-898-6

                        20,3

                        20,3

                        Glycolic acid

                        Non-active substance

                        79-14-1

                        201-180-5

                        0,0

                        0,0

                        Lactic acid

                        Non-active substance

                        79-33-4

                        201-196-2

                        0,0

                        0,0

                        Citric acid

                        Non-active substance

                        77-92-9

                        201-069-1

                        0,0

                        0,0

                  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.

                        Precautionary statements

                        Do not breathe vapours.
                        Wear protective clothing.
                        Wear eye protection.
                        Wear protective gloves.
                        Wear face protection.
                        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.
                        Immediately call a doctor.
                        IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
                        Keep only in original container.
                        Store in a well-ventilated place.Keep container tightly closed.
                        Absorb spillage to prevent material damage.
                        Dispose of contents in accordance with local/regional/national/international regulations.

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

            4.1.   Use description

               Table 8

               Use # 1 – Cleaning in place (CIP) with 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
                        In food and feed areas

                        Application method(s)

                        Closed system
                        For disinfection of pipes, tanks, and other parts of the closed system.

                                    —

                                    Biocidal product (semi-)automatically dosed in the CIP vessel (either by volume or conductivity measurements)

                                    —

                                    Circulation in a closed CIP system

                        Application rate(s) and frequency

                                    —

                                    For an effect on bacteria and on yeasts: Dilution rate: 1,5 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 2 %. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

                        Category(ies) of users

                        Industrial
                        Trained professional

                        Pack sizes and packaging material

                                    •

                                    Jerrycan (PE-HD), containing: 10 to 12,5 kg (*8).

                                    •

                                    Jerrycan (PE-HD), containing: 20 to 25 kg (*8).

                                    •

                                    Drums (PE-HD) containing 200 to 250 kg (*8).

                                    •

                                    Containers (PE-HD) containing 600 to 750 kg (*8).

                                    •

                                    IBC (PE-HD) containing 1 100  to 1 250  kg (*8)

                                    •

                                    Bulk delivery.

                  4.1.1.   Use-specific instructions for use

            In case of re-use of the disinfectant solution for CIP procedures, the active substance concentration must be measured and restored to its intended level before re-use.
            4.1.2.   Use-specific risk mitigation measures

               During the mixing, loading and application phase:

                        —

                        Transfer in closed systems and industrial RMM excluding risk for skin and eye exposure, IBC containers containing the product are connected to CIP via installed pipes; connections are made with dry coupling.

                  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

               For an effect on bacteria and on yeasts

                        •

                        Rinsing and cleaning before disinfection:

                  Not mandatory (even if a pre-rinsing is always recommended and usually performed by the users).
            For disinfection procedures in slaughterhouses, cleaning with a cold alkaline solution is mandatory before disinfection.

                        •

                        Disinfecting cycle:

                                    —

                                    Dilution of the concentrated product in tap water before use:1,5 %

                              In case of outbreaks of Pediococcus damnosus, the products must be used at 2 %.

                                    —

                                    Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.

                        •

                        Final rinsing with drinking water

                  5.2.   Risk mitigation measures

            Use in well-ventilated places.
            During the mixing, loading and application phases:
            Wear a protective coverall. Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information). Use eye protection during handling of the product. Wear face protection.
            5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

            Particulars of likely direct or indirect adverse effects:

                        •

                        Severe chemical burns and/or corrosion of the eyes, mucosae, respiratory and digestive tract with the risk of perforation and intense pain. Absence of visual oral burns does not exclude esophageal burns.

                        •

                        If aspiration and/or ingestion occurs this may induce chemical pneumonia and metabolic acidosis.

                  First aid instructions:

                        •

                        Relocate the individual from the exposure source and remove any contaminated/spattered clothing articles.

                        •

                        In case of inhalation: Remove to fresh air. Allow the affected person to rest. Not expected to require first aid measures.

                        •

                        In case of eye exposure: Seek medical attention immediately. ALWAYS check for and remove contact lenses. Rinse immediately with plenty of water during 15 minutes and keep the eyelids open. (Keep a bottle of water at hand).

                        •

                        In case of skin contact: Obtain medical attention. Remove contaminated clothing and shoes. Wash affected area with plenty of water. NO scrubbing.

                        •

                        In case of mouth contact or ingestion: Do NOT induce vomiting, if the individual is conscious, able to swallow saliva without coughing and ingestion occurred in less than one hour proceed to mouth wash with plenty of water. Take to hospital.

                        •

                        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.

                        •

                        Keep the individual calm and at rest, conserve body temperature and control breathing. If necessary check for pulse and initiate artificial respiration.

                        •

                        If symptoms persist or worsen bring individual to a healthcare center, bring packaging or label whenever possible.

                        •

                        NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

                  Advice for medical and healthcare personnel:

                        •

                        In case of ingestion consider performing an endoscopic procedure.

                        •

                        The use of ipecac syrup, neutralization and activated charcoal is not advised.

                        •

                        Symptomatic and supportive treatment.

                        •

                        WHEN ASKING FOR MEDICAL ADVICE KEEP PACKAGING OR LABEL AT HAND AND CALL YOUR LOCAL POISON CONTROL CENTER

                  Emergency measures to protect the environment:

                        •

                        Prevent entry into sewers and public waters.

                        •

                        Clean up any spills as soon as possible, using an absorbent material (e.g. earth, sand) to collect the spill. Use suitable disposal containers.

                  5.4.   Instructions for safe disposal of the product and its packaging

            Keep only in the original packaging tightly closed in a cool and well-ventilated place
            Keep the product away from direct sunlight, source of heat and ignition.
            The product must be stored at temperatures below +30 °C.
            Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) nor down the drains
            Dispose of unused product, its packaging and all other waste, in accordance with local regulations.
            5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

               Storage conditions:

                        •

                        Store in a clean area allowing recuperation of leaks and effusion.

                        •

                        Protect from freezing. Provide local exhaust or general room ventilation to minimize dust and/or vapour concentrations. Keep packaging closed when not in use.

                        •

                        Handle in accordance with good industrial hygiene and safety procedures.

                  Packaging material: Use approved materials suitable for corrosive liquids.

               Shelf-life: 12 months in the original packaging.
            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)

                        SOPURCLEAN CIP OP

                        Authorisation number

                        EU-0021157-0008 1-4

                        Common name

                        IUPAC name

                        Function

                        CAS number

                        EC number

                        Content (%)

                        Octanoic acid

                        Active Substance

                        124-07-2

                        204-677-5

                        1,8

                        Decanoic acid

                        Active Substance

                        334-48-5

                        206-376-4

                        1,2

                        Sulfuric acid

                        Non-active substance

                        7664-93-9

                        231-639-5

                        4,68

                        Methane sulfonic acid

                        Non-active substance

                        75-75-2

                        200-898-6

                        20,3

               (*1)  Depending on biocidal product specific weight.

               (*2)  Depending on biocidal product specific weight.

               (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.

               (*3)  Depending on biocidal product specific weight.

               (*4)  Depending on biocidal product specific weight.

               (*5)  Depending on biocidal product specific weight.

               (*6)  Depending on biocidal product specific weight.

               (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.

               (*7)  Depending on biocidal product specific weight.

               (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.

               (*8)  Depending on biocidal product specific weight.

               (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.