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Document 02023R1763-20240812

    Consolidated text: Commission Implementing Regulation (EU) 2023/1763 of 12 September 2023 granting a Union authorisation for the biocidal product family Lactic acid Family – Quatchem in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)

    ELI: http://data.europa.eu/eli/reg_impl/2023/1763/2024-08-12

    02023R1763 — EN — 12.08.2024 — 001.001


    This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

    ►B

    COMMISSION IMPLEMENTING REGULATION (EU) 2023/1763

    of 12 September 2023

    granting a Union authorisation for the biocidal product family ‘Lactic acid Family – Quatchem’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

    (Text with EEA relevance)

    (OJ L 225 13.9.2023, p. 5)

    Amended by:

     

     

    Official Journal

      No

    page

    date

    ►M1

    COMMISSION IMPLEMENTING REGULATION (EU) 2024/1990 of 22 July 2024

      L 1990

    1

    23.7.2024




    ▼B

    COMMISSION IMPLEMENTING REGULATION (EU) 2023/1763

    of 12 September 2023

    granting a Union authorisation for the biocidal product family ‘Lactic acid Family – Quatchem’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

    (Text with EEA relevance)



    Article 1

    A Union authorisation with authorisation number EU-0030143-0000 is hereby granted to ►M1  Neogen Italia S.r.l. ◄ for the making available on the market and use of the biocidal product family ‘Lactic acid Family – Quatchem’ subject to compliance with the terms and conditions set out in the Annex.

    The Union authorisation is valid from 3 October 2023 to 30 September 2033.

    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.

    ▼M1




    ANNEX

    SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

    Lactic acid Family – Quatchem

    Product type(s)

    PT03: Veterinary hygiene

    Authorisation number: EU-0030143-0000

    R4BP asset number: EU-0030143-0000

    PART I

    FIRST INFORMATION LEVEL

    1.    ADMINISTRATIVE INFORMATION

    1.1.    Family name



    Name

    Lactic acid Family – Quatchem

    1.2.    Product type(s)



    Product type(s)

    PT03: Veterinary hygiene

    1.3.    Authorisation holder



    Name and address of the authorisation holder

    Name

    Neogen Italia S.r.l.

    Address

    c/o REGUS Palazzo Bernini

    Centro Direzionale Milano Due, Via Fratelli Cervi snc

    20054 - Segrate, Milano

    Italy

    Authorisation number

     

    EU-0030143-0000

    R4BP asset number

     

    EU-0030143-0000

    Date of the authorisation

     

    3 October 2023

    Expiry date of the authorisation

     

    30 September 2033

    1.4.    Manufacturer(s) of the product



    Name of manufacturer

    Quat-Chem Ltd. A Neogen Company

    Address of manufacturer

    1-4 Sandfield Industrial Park, Dodgson Street, Rochdale OL16 5SJ Lancashire United Kingdom of Great Britain and Northern Ireland (the)

    Location of manufacturing sites

    Quat-Chem Ltd. A Neogen Company site 1

    1-4 Sandfield Industrial Park, Dodgson Street, Rochdale OL16 5SJ Lancashire United Kingdom of Great Britain and Northern Ireland (the)

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



    Active substance

    L-(+)-lactic acid

    Name of manufacturer

    Purac Biochem bv

    Address of manufacturer

    Arkelsedijk 46 4206 AC Gorinchem Netherlands (the)

    Location of manufacturing sites

    Purac Biochem bv site 1

    Arkelsedijk 46 4206 AC Gorinchem Netherlands (the)



    Active substance

    L-(+)-lactic acid

    Name of manufacturer

    Jungbunzlauer S. A

    Address of manufacturer

    Z.I. et Portuaire, B.P. 32 FR-67390 Marckolsheim France

    Location of manufacturing sites

    Jungbunzlauer S. A site 1

    Z.I. et Portuaire, B.P. 32 FR-67390 Marckolsheim France

    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 (%)

    L-(+)-lactic acid

     

    active substance

    79-33-4

    201-196-2

    4 - 4 % (w/w)

    2.2.    Type(s) of formulation



    Formulation type(s)

    AL Any other liquid

    PART II

    SECOND INFORMATION LEVEL - META SPC(S)

    1.    META SPC 1 ADMINISTRATIVE INFORMATION

    1.1.    Meta SPC 1 identifier



    Identifier

    Meta SPC: meta SPC 1

    1.2.    Suffix to the authorisation number



    Number

    1-1

    1.3.    Product type(s)



    Product type(s)

    PT03: Veterinary hygiene

    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 (%)

    L-(+)-lactic acid

     

    active substance

    79-33-4

    201-196-2

    4 - 4 % (w/w)

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



    Formulation type(s)

    AL Any other liquid

    3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1



    Hazard statements

    H315: Causes skin irritation.

    H318: Causes serious eye damage.

    Precautionary statements

    P280: Wear protective gloves.

    P280: Wear eye protection.

    P264: Wash hands thoroughly after handling.

    P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

    P310: Immediately call a doctor.

    P302+P352: IF ON SKIN: Wash with plenty of water.

    P332+P313: If skin irritation occurs: Get medical advice.

    P332+P313: If skin irritation occurs: Get medical attention.

    P362+P364: Take off contaminated clothing and wash it before reuse.

    P501: Dispose of contents to hazardous or special waste collection point in accordance with national regulations.

    P501: Dispose of container to hazardous or special waste collection point in accordance with national regulations.

    4.    AUTHORISED USE(S) OF THE META SPC

    4.1.    Use description 1



    Table 1.

    Use # 1.1 – Post milking teat disinfection – manual dipping

    Product type

    PT03: Veterinary hygiene

    Where relevant, an exact description of the authorised use

    -

    Target organism(s) (including development stage)

    Scientific name: Bacteria

    Common name: Bacteria

    Development stage: -

    Scientific name: Yeasts

    Common name: Yeasts

    Development stage: -

    Field(s) of use

    indoor use

    Teat disinfection post-milking by manual dipping using a dip cup

    Application method(s)

    Method: Manual dipping using a dip cup

    Detailed description: Contact time for dipping at 30 oC in dirty conditions: - 5 minutes for bacteria and yeasts.

    Application rate(s) and frequency

    Application Rate: 5 to 10 ml per teat

    Dilution (%): RTU (Ready-to-use) product

    Number and timing of application:

    up to twice per day

    Category(ies) of users

    professional

    Pack sizes and packaging material

    1 000 litre high density polyethylene (HDPE) container with HDPE closure;

    200 litre plastic drum with HDPE closure;

    25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap;

    5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap.

    4.1.1.    Use-specific instructions for use

    See general directions for use.

    Product to be applied post-milking by use of a dipping cup.

    Pre-clean teat with dry wipe, pour the product into the reservoir of the dip cup. When using a dip cup, the cup is applied to each teat in turn and the operator squeezes the product from the reservoir into the cup. The cup has a non-return value so any residual product cannot go back into the reservoir.

    4.1.2.    Use-specific risk mitigation measures

    See general directions for use.

    4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

    See general directions for use.

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

    See general directions for use.

    4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

    See general directions for use.

    4.2.    Use description 2



    Table 2.

    Use # 1.2 – Post milking teat disinfection - spraying

    Product type

    PT03: Veterinary hygiene

    Where relevant, an exact description of the authorised use

    -

    Target organism(s) (including development stage)

    Scientific name: Bacteria

    Common name: Bacteria

    Development stage: -

    Scientific name: Yeasts

    Common name: Yeasts

    Development stage: -

    Field(s) of use

    indoor use

    Teat disinfection post-milking by using hand-held sprayer

    Application method(s)

    Method: Manual spraying using hand-held sprayer

    Detailed description: Contact time for spraying at 30 oC in dirty conditions: - 5 minutes for bacteria and yeasts.

    Application rate(s) and frequency

    Application Rate: 5 to 10 ml per teat

    Dilution (%): RTU product

    Number and timing of application:

    up to twice per day

    Category(ies) of users

    professional

    Pack sizes and packaging material

    1 000 litre HDPE container with HDPE closure;

    200 litre plastic drum with HDPE closure;

    25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap;

    5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap.

    4.2.1.    Use-specific instructions for use

    See general directions for use.

    Product to be applied post-milking by use of a hand-held sprayer.

    Pre-clean teat with dry wipe, pour the product into the reservoir of the sprayer. The operator will spray each animal once after milking.

    4.2.2.    Use-specific risk mitigation measures

    See general directions for use.

    Professional users have to ensure that professional bystanders are not present in the treatment area during disinfection process by spraying. If it is necessary for professional bystanders to be present, professional users have to ensure that those bystanders wear the same type of PPE as the operator.

    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 OF THE META SPC 1

    5.1.    Instructions for use

    See use-specific instruction for use of meta SPC 1.

    Always read the label or leaflet before use.

    The product must be brought to room temperature before use. The amount of product applied per teat is dependent upon the animal being treated. For large mammals (cows, camels) – up to 10 ml per teat, and for small mammals (sheep, goats) – up to 5 ml per teat. Make sure that the teats are fully covered with disinfectant. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing for at least 5 minutes).

    5.2.    Risk mitigation measures

    The use of eye protection consistent with European standard EN ISO 16321 or equivalent during handling of the product is mandatory.

    Avoid hand to eye transfer.

    Wear protective chemical resistant gloves during product handling phase (nitrile gloves – classified under European standards EN ISO 374 or EN 455 or equivalent).

    The full titles of the European standards indicated here are available under section 6.

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

    IF ON SKIN: Immediately wash with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

    IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

    IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.

    IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

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

    At the end of the treatment, dispose of unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

    5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage

    Keep out of reach of children.

    Store in original container tightly closed.

    Store between 0 °C and + 30 °C.

    Shelf life: 24 months

    6.    OTHER INFORMATION

    The full titles of the European standards referenced in section 5.2 ‘Risk mitigation measures’ are :

    EN ISO 16321 - Eye and face protection for occupational use
    EN ISO 374 – Protective gloves against dangerous chemicals and microorganisms
    EN 455 - Medical gloves for single use

    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)

    Synodex

    Market area: EU

    Lactopost

    Market area: EU

    Lactopost Y

    Market area: EU

    Lactopost Plus

    Market area: EU

    Lactopost Extra

    Market area: EU

    Synodex Y

    Market area: EU

    Synodex Extra

    Market area: EU

    Synodex Plus

    Market area: EU

    Udder X

    Market area: EU

    Teat Care

    Market area: EU

    Lacto Gold

    Market area: EU

    Lacto Extra

    Market area: EU

    Lactogold

    Market area: EU

    Lacto Spray

    Market area: EU

    Authorisation number

    EU-0030143-0001 1-1

    Common name

    IUPAC name

    Function

    CAS number

    EC number

    Content (%)

    L-(+)-lactic acid

     

    active substance

    79-33-4

    201-196-2

    4

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



    Trade name(s)

    Laxsan

    Market area: EU

    Hexsan

    Market area: EU

    Lactopost R

    Market area: EU

    Laxsan R

    Market area: EU

    Hexfoam

    Market area: EU

    Deosan LA1

    Market area: EU

    Hexsan Extra

    Market area: EU

    Hexsan Plus

    Market area: EU

    Laxsan Plus

    Market area: EU

    Laxsan Extra

    Market area: EU

    Hexsan R

    Market area: EU

    LA1

    Market area: EU

    Condition Pink

    Market area: EU

    Authorisation number

    EU-0030143-0002 1-1

    Common name

    IUPAC name

    Function

    CAS number

    EC number

    Content (%)

    L-(+)-lactic acid

     

    active substance

    79-33-4

    201-196-2

    4

    1.    META SPC 2 ADMINISTRATIVE INFORMATION

    1.1.    Meta SPC 2 identifier



    Identifier

    Meta SPC: meta SPC 2

    1.2.    Suffix to the authorisation number



    Number

    1-2

    1.3.    Product type(s)



    Product type(s)

    PT03: Veterinary hygiene

    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 (%)

    L-(+)-lactic acid

     

    active substance

    79-33-4

    201-196-2

    4 - 4 % (w/w)

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



    Formulation type(s)

    AL Any other liquid

    3.    HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2



    Hazard statements

    H315: Causes skin irritation.

    H318: Causes serious eye damage.

    EUH208: Contains <name of sensitising substance>. May produce an allergic reaction.

    Precautionary statements

    P280: Wear protective gloves.

    P280: Wear eye protection.

    P264: Wash hands thoroughly after handling.

    P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

    P310: Immediately call a doctor.

    P302+P352: IF ON SKIN: Wash with plenty of water.

    P332+P313: If skin irritation occurs: Get medical advice.

    P332+P313: If skin irritation occurs: Get medical attention.

    P362+P364: Take off contaminated clothing and wash it before reuse.

    P501: Dispose of contents to hazardous or special waste collection point in accordance with national regulations.

    P501: Dispose of container to hazardous or special waste collection point in accordance with national regulations.

    4.    AUTHORISED USE(S) OF THE META SPC

    4.1.    Use description 1



    Table 1.

    Use # 3.1 – Post milking teat disinfection – manual dipping

    Product type

    PT03: Veterinary hygiene

    Where relevant, an exact description of the authorised use

    -

    Target organism(s) (including development stage)

    Scientific name: Bacteria

    Common name: Bacteria

    Development stage: -

    Scientific name: Yeasts

    Common name: Yeasts

    Development stage: -

    Field(s) of use

    indoor use

    Teat disinfection post-milking by manual dipping using a dip cup

    Application method(s)

    Method: Manual dipping using a dip cup

    Detailed description: Contact time for dipping at 30 oC in dirty conditions: - 5 minutes for bacteria and yeasts.

    Application rate(s) and frequency

    Application Rate: 5 to 10 ml per teat

    Dilution (%): RTU product

    Number and timing of application:

    up to twice per day

    Category(ies) of users

    professional

    Pack sizes and packaging material

    1 000 litre HDPE container with HDPE closure;

    200 litre plastic drum with HDPE closure;

    25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap;

    5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap.

    4.1.1.    Use-specific instructions for use

    See general directions for use.

    Product to be applied post-milking by use of a dipping cup.

    Pre-clean teat with dry wipe, pour the product into the reservoir of the dip cup. When using a dip cup, the cup is applied to each teat in turn and the operator squeezes the product from the reservoir into the cup. The cup has a non-return value so any residual product cannot go back into the reservoir.

    4.1.2.    Use-specific risk mitigation measures

    See general directions for use.

    4.1.3.    Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

    See general directions for use.

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

    See general directions for use.

    4.1.5.    Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

    See general directions for use.

    4.2.    Use description 2



    Table 2.

    Use # 3.2 – Post milking teat disinfection - spraying

    Product type

    PT03: Veterinary hygiene

    Where relevant, an exact description of the authorised use

    -

    Target organism(s) (including development stage)

    Scientific name: Bacteria

    Common name: Bacteria

    Development stage: -

    Scientific name: Yeasts

    Common name: Yeasts

    Development stage: -

    Field(s) of use

    indoor use

    Teat disinfection post-milking by using hand-held sprayer

    Application method(s)

    Method: Manual spraying using hand-held sprayer

    Detailed description: Contact time for spraying at 30 oC in dirty conditions: - 5 minutes for bacteria and yeasts.

    Application rate(s) and frequency

    Application Rate: 5 to 10 ml per teat

    Dilution (%): RTU product

    Number and timing of application:

    up to twice per day

    Category(ies) of users

    professional

    Pack sizes and packaging material

    1 000 litre HDPE container with HDPE closure;

    200 litre plastic drum with HDPE closure;

    25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap;

    5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap.

    4.2.1.    Use-specific instructions for use

    See general directions for use.

    Product to be applied post-milking by use of a hand-held sprayer.

    Pre-clean teat with dry wipe, pour the product into the reservoir of the sprayer. The operator will spray each animal once after milking.

    4.2.2.    Use-specific risk mitigation measures

    See general directions for use.

    Professional users have to ensure that professional bystanders are not present in the treatment area during disinfection process by spraying. If it is necessary for professional bystanders to be present, professional users have to ensure that those bystanders wear the same type of PPE as the operators.

    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 OF THE META SPC 2

    5.1.    Instructions for use

    See use-specific instruction for use of meta SPC 2.

    Always read the label or leaflet before use.

    The product must be brought to room temperature before use. The amount of product applied per teat is dependent upon the animal being treated. For large mammals (cows, camels) – up to 10 ml per teat, and for small mammals (sheep, goats) – up to 5 ml per teat. Make sure that the teats are fully covered with disinfectant. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing for at least 5 minutes).

    5.2.    Risk mitigation measures

    The use of eye protection consistent with European standard EN ISO 16321 or equivalent during handling of the product is mandatory.

    Avoid hand to eye transfer.

    Wear protective chemical resistant gloves during product handling phase (nitrile gloves – classified under European standards EN ISO 374 or EN 455 or equivalent).

    The full titles of the European standards indicated here are available under section 6.

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

    IF ON SKIN: Immediately wash with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

    IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.

    IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.

    IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance.

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

    At the end of the treatment, dispose of unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

    5.5.    Conditions of storage and shelf-life of the product under normal conditions of storage

    Keep out of reach of children.

    Store in original container tightly closed.

    Store between 0 °C and + 30 °C.

    Shelf life: 24 months

    6.    OTHER INFORMATION

    The full titles of the EN standards referred to in section 5.2 are the following:

    EN ISO 16321 - Eye and face protection for occupational use
    EN ISO 374 – Protective gloves against dangerous chemicals and micro-organisms
    EN 455 - Medical gloves for single use

    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)

    Synoshield

    Market area: EU

    Lactopost G

    Market area: EU

    Synoshield P

    Market area: EU

    Lactopost P

    Market area: EU

    Synoshield G

    Market area: EU

    Lactoshield

    Market area: EU

    Lactoshield Plus

    Market area: EU

    Lactoshield Extra

    Market area: EU

    Synoshield Extra

    Market area: EU

    Synoshield Plus

    Market area: EU

    Lactopost Protect

    Market area: EU

    Udder Shield

    Market area: EU

    Teat Care

    Market area: EU

    Mint Lacto Plus

    Market area: EU

    Lacto Care G

    Market area: EU

    Lactosal

    Market area: EU

    Lacto Care P

    Market area: EU

    Previoshield

    Market area: EU

    Authorisation number

    EU-0030143-0003 1-2

    Common name

    IUPAC name

    Function

    CAS number

    EC number

    Content (%)

    L-(+)-lactic acid

     

    active substance

    79-33-4

    201-196-2

    4

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