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Document 32023R2747

Commission Implementing Regulation (EU) 2023/2747 of 8 December 2023 amending Implementing Regulation (EU) 2022/1391 granting a Union authorisation for the biocidal product family Lactic acid based products – CID Lines NV in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

C/2023/8385

OJ L, 2023/2747, 11.12.2023, ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

Legal status of the document In force

ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj

European flag

Official Journal
of the European Union

EN

Series L


2023/2747

11.12.2023

COMMISSION IMPLEMENTING REGULATION (EU) 2023/2747

of 8 December 2023

amending Implementing Regulation (EU) 2022/1391 granting a Union authorisation for the biocidal product family ‘Lactic acid based products – CID Lines NV’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 48(1), point (a), thereof,

Whereas:

(1)

On 26 July 2022, a Union authorisation was granted to CID Lines NV for the making available on the market and use of the biocidal product family ‘Lactic acid-based products – CID Lines NV’ by Commission Implementing Regulation (EU) 2022/1391 (2). In Annex I to Implementing Regulation (EU) 2022/1391 the authorisation holder was required to conduct a long-term storage stability test at ambient temperature of ‘Lactic acid-based products – CID Lines NV’ in commercial packaging in which the products in the family will be made available on the market and to submit the results of the test to the Agency by 1 March 2023.

(2)

The authorisation holder provided the required data on 28 February 2023 to the European Chemicals Agency (ECHA), recorded under the case number BC-RC051007-54. The evaluating competent authority of Belgium submitted the conclusions of its evaluation to ECHA on 9 March 2023.

(3)

On 30 June 2023, ECHA submitted the opinion of the Biocidal Products Committee (3) to the Commission concluding that the submitted data confirms the shelf life of 2 years for the products of the biocidal product family ‘CID Lines – Lactic acid-based products’, except for the packaging Wipe 4, 2L (105 wipes) from meta SPC 7 for which a two-year shelf life could not be confirmed.

(4)

The Commission concurs with the opinion of ECHA and considers it therefore appropriate to amend the Union authorisation of the biocidal product family ‘Lactic acid-based products – CID LINES NV’.

(5)

Since the shelf life of 2 years could not be confirmed for the packaging Wipe 4, 2L (105 wipes) of the biocidal product family, the conditions of Article 19 of Regulation (EU) No 528/2012 are not met for this packaging type for the duration of the shelf life.

(6)

The packaging Wipe 4, 2L (105 wipes) should therefore be removed from the entry ‘Pack sizes and packaging material’ in tables 13, 14, 15, 16, 17 and 18 of meta SPC 7 in Annex II to Implementing Regulation (EU) 2022/1391.

(7)

On 4 August 2023, the Commission informed the authorisation holder of its intention to amend the Union authorisation for the biocidal product family ‘Lactic acid-based products – CID Lines NV’ and gave the opportunity to submit comments or additional information in accordance with Article 48(2) of Regulation (EU) No 528/2012. In its response received on the same day, the authorisation holder agreed with the intended amendment of the authorisation for the packaging Wipe 4, 2L (105 wipes) in meta SPC 7 for which a two-year shelf life could not be confirmed.

(8)

In order to enhance clarity and ease the access of users and interested parties to the final version of the SPC which is to be published in the Register of Biocidal Products, Annex II to Implementing Regulation (EU) 2022/1391 should be replaced in its entirety.

(9)

Implementing Regulation (EU) 2022/1391 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Annex II to Implementing Regulation (EU) 2022/1391 is replaced by the text in the Annex to this Regulation.

Article 2

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 8 December 2023.

For the Commission

The President

Ursula VON DER LEYEN


(1)   OJ L 167, 27.6.2012, p. 1.

(2)  Commission Implementing Regulation (EU) 2022/1391 of 26 July 2022 granting a Union authorisation for the biocidal product family ‘Lactic acid based products – CID Lines NV’ (OJ L 211, 12.8.2022, p. 1).

(3)  Opinion of the evaluation of post authorisation conditions for the Union authorisation of Lactic acid based products – CID Lines NV’. ECHA/BPC/384/2023 of 7 June 2023.


ANNEX

‘ANNEX II

Summary of product characteristics for a biocidal product family

Lactic acid based products – CID LINES NV

Product type 1 – Human hygiene (Disinfectants)

Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Product type 3 – Veterinary hygiene (Disinfectants)

Product type 4 – Food and feed area (Disinfectants)

Authorisation number: EU-0027740-0000

R4BP asset number: EU-0027740-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

Name

Lactic acid based products – CID LINES NV

1.2.   Product type(s)

Product type(s)

PT01 – Human hygiene (Disinfectants)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT03 – Veterinary hygiene (Disinfectants)

PT04 – Food and feed area (Disinfectants)

1.3.   Authorisation holder

Name and address of the authorisation holder

Name

CID LINES NV

Address

Waterpoortstraat 2, 8900 Ieper Belgium

Authorisation number

EU-0027740-0000

R4BP asset number

EU-0027740-0000

Date of the authorisation

31 December 2023

Expiry date of the authorisation

31 August 2032

1.4.   Manufacturer(s) of the biocidal products

Name of manufacturer

CID LINES NV

Address of manufacturer

Waterpoortstraat 2, 8900 Ieper Belgium

Location of manufacturing sites

Waterpoortstraat 2, 8900 Ieper Belgium

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 Gorinchem Netherlands

Location of manufacturing sites

Arkelsedijk 46, 4206 Gorinchem Netherlands


Active substance

L-(+)-lactic acid

Name of manufacturer

Jungbunzlauer S.A.

Address of manufacturer

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

Location of manufacturing sites

Z.I. et Portuaire, B.P. 32, 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 (%)

Min

Max

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

2,0

70,0

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

0,0

12,0

Sodium lauryl ether sulfate

Alcohols, C12-14, ethoxylated, sulfates, sodium salts

Non-active substance

68891-38-3

500-234-8

0,0

8,4

Sulfonic acids, C14-17-sec-alkane, sodium salts

Sulfonic acids, C14-17-sec-alkane, sodium salts

Non-active substance

97489-15-1

307-055-2

0,0

2,25

C6 alkyl glucoside

Hexyl D-Glucoside

Non-active substance

54549-24-5

259-217-6

0,0

2,4

Isopropanol

Propan-2-ol

Non-active substance

67-63-0

200-661-7

0,0

5,0

Methanesulfonic acid

Methanesulfonic acid

Non-active substance

75-75-2

200-898-6

0,0

19,5

Sulphuric acid

Sulphuric acid

Non-active substance

7664-93-9

231-639-5

0,0

10,5

Butyldiglycol

2-(2-butoxyethoxy)ethanol

Non-active substance

112-34-5

203-961-6

0,0

10,0

2.2.   Type(s) of formulation

Formulation(s)

AL – Any other liquid

SL – Soluble concentrate

WI – Wipes

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: Ready to use hygienic handwash (PT1)

1.2.   Suffix to the authorisation number

Number

1-1

1.3.   Product type(s)

Product type(s)

PT01 – Human hygiene (Disinfectants)

2.   META SPC 1 COMPOSITION

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

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

3,6

3,6

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

5,0

5,0

Isopropanol

Propan-2-ol

Non-active substance

67-63-0

200-661-7

4,0

4,0

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

Formulation(s)

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements

Causes serious eye damage.

Precautionary statements

Wear eyes/face protection.

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.

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

4.1.   Use description

Table 1

Use # 1 – Hygienic handwash for professional use

Product type

PT01 – Human hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: Other: Bacteria

Common name: Bacteria

Development stage:

Scientific name: Other: Yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Food and feed industry, Public field and Kitchens:

Hygienic handwash

Application method(s)

Method: -

Detailed description:

-

Application rate(s) and frequency

Application Rate: 10 mL of undiluted product (that is four pushes for both hands together)

Dilution (%): -

Number and timing of application:

Apply 10 mL of undiluted product (that is four pushes for both hands together) and wash your hands for at least one minute according to the recommended hand washing procedure, before rinse and dry.

Category(ies) of users

Professional

Pack sizes and packaging material

50 mL, 75 mL, 100 mL, 150 mL, 500 mL, 1L, 5L, 10L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

HDPE (High Density Polyethylene)

4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 1

4.1.2.   Use-specific risk mitigation measures

/

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 Meta SPC 1

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

see general directions for Meta SPC 1

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

see general directions for Meta SPC 1

5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1

5.1.   Instructions for use

Wet your hands with clean, running water at room temperature

Turn off the tap

Apply 10 mL of undiluted product and rub your hands for at least one minute according to the recommended hand washing procedure, before rinse and dry.

For professional use only

5.2.   Risk mitigation measures

/

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

IF ON SKIN: Immediately wash skin 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 INHALED: If symptoms occur 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. Immediately call 112/ambulance for medical assistance.

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

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

The shelf-life of the products is two years.

6.   OTHER INFORMATION

/

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

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

Trade name(s)

Kenosan Hand Scrub

Market area: EU

Authorisation number

EU-0027740-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

3,6

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

5,0

Isopropanol

Propan-2-ol

Non-active substance

67-63-0

200-661-7

4,0

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier

Meta SPC 2: Ready to use Algaecide

1.2.   Suffix to the authorisation number

Number

1-2

1.3.   Product type(s)

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (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

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

2,0

2,0

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

0,6

0,9

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

Formulation(s)

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements

Causes serious eye irritation.

Precautionary statements

If medical advice is needed, have product container or label at hand.

Keep out of reach of children.

Read carefully and follow all instructions.

Wash hands thoroughly after handling.

Wear eyes/face protection.

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

If skin irritation occurs:Get medical advice.

If eye irritation persists:Get medical advice.

Take off contaminated clothing.And wash it before reuse.

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

4.1.   Use description

Table 2

Use # 1 – Ready to use algaecide for professional use

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeasts

Development stage:

Scientific name: unicellular green algae and blue-green algae

Common name: cyanobacteria

Development stage:

Field(s) of use

Indoor

Outdoor

Public field: Ready-to-use algaecide, on hard/non-porous surfaces without prior cleaning.

Application method(s)

Method: By brushing, by spraying (low pressure) or pouring

Detailed description:

/

Application rate(s) and frequency

Application Rate: 100 mL/m2

Dilution (%): -

Number and timing of application:

Active against bacteria, yeasts and unicellular green algae and blue-green algae (cyanobacteria):

With undiluted product at 20 – 25 °C

In 3h contact time

100 mL/m2

The biocidal product is not intended to be used on surfaces that come into contact with food and feed.

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 2

4.1.2.   Use-specific risk mitigation measures

/

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 for Meta SPC 2

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

see general directions for use for Meta SPC 2

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

see general directions for use for Meta SPC 2

4.2.   Use description

Table 3

Use # 2 – Ready to use algaecide for non-professional use

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeasts

Development stage:

Scientific name: unicellular green algae and blue-green algae

Common name: Cyanobacteria

Development stage:

Field(s) of use

Indoor

Outdoor

Public field: Ready-to-use algaecide, on hard/non-porous surfaces without prior cleaning.

Application method(s)

Method: By brushing, by spraying (low pressure) or pouring

Detailed description:

/

Application rate(s) and frequency

Application Rate: 100 mL/m2

Dilution (%): -

Number and timing of application:

Active against bacteria, yeasts and unicellular green algae and blue-green algae (cyanobacteria):

With undiluted product at 20 – 25 °C

In 3h contact time

100 mL/m2

The biocidal product is not intended to be used on surfaces that come into contact with food and feed.

Category(ies) of users

General public (non-professional)

Pack sizes and packaging material

1 L, 5 L, 10 L

1 kg, 5 kg, 10 kg

HDPE (High Density Polyethylene)

4.2.1.   Use-specific instructions for use

see general directions for use for Meta SPC 2

4.2.2.   Use-specific risk mitigation measures

/

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 for Meta SPC 2

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

see general directions for use for Meta SPC 2

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 for Meta SPC 2

5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2

5.1.   Instructions for use

Comply with the instructions for use

The surfaces to be disinfected must be wet enough in order to be kept wet during the approved contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”.

The required contact time has to be respected until further treatments (for example brushing the surfaces).

Use 100 mL solution/m2

5.2.   Risk mitigation measures

/

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

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for five minutes. 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.

If medical advice is needed, have product container or label at hand

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

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

The shelf-life of the products is two years.

Keep out of reach of children and non-target animals/pets.

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)

RTU Algaecide

Market area: EU

Authorisation number

EU-0027740-0002 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

2,0

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

0,6

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

Identifier

Meta SPC 3: concentrated algaecide and hard surface disinfection in food industry

1.2.   Suffix to the authorisation number

Number

1-3

1.3.   Product type(s)

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

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

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

70,0

70,0

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

6,0

6,0

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

Causes severe skin burns and eye damage.

Causes serious eye damage.

Precautionary statements

Do not breathe vapours.

Wash hands thoroughly after handling.

Wear protective gloves.

Wear protective clothing.

Wear eyes/face protection.

IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.

IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.

IF INHALED:Remove person to fresh air and keep comfortable for breathing.

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.

Wash contaminated clothing before reuse.

Store locked up.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

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

4.1.   Use description

Table 4

Use # 1 – concentrated algaecide

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: unicellular green algae and blue-green algae

Common name: Cyanobacteria

Development stage:

Field(s) of use

Indoor

Outdoor

Food and feed industry; Public field:

Concentrated algaecide, on hard/non-porous surfaces without prior cleaning.

Application method(s)

Method: By spraying (low pressure) or pouring

Detailed description:

/

Application rate(s) and frequency

Application Rate: 100 mL/m2

Dilution (%): 0,5 %

Number and timing of application:

Active against unicellular green algae and blue-green algae (cyanobacteria): 100 mL/m2

Dilute the product to 0,5 % in water, to reach an in use concentration of 0,35 % Lactic acid.

at 20– 25 °C

In 3h contact time

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 3

4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 3

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

see general directions for use for Meta SPC 3

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

see general directions for use for Meta SPC 3

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

see general directions for use for Meta SPC 3

4.2.   Use description

Table 5

Use # 2 – Disinfection of hard/non-porous surfaces in the food industry (for example processing machines)

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

in Food/feed industry:

Disinfection of hard/non-porous surfaces (for example processing machines) without prior cleaning

Application method(s)

Method: Spraying or soaking

Detailed description:

Spraying

Soaking (the bath is intended to be used only once)

Application rate(s) and frequency

Application Rate: 100 mL/m2

Dilution (%): 4 %

Number and timing of application:

Active against bacteria and yeasts at +40 °C:

Dilute the product to 4 % in water, to reach an in use concentration of 2,8 % Lactic acid.

In five seconds contact time

100 mL/m2

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.2.1.   Use-specific instructions for use

see general directions for use for Meta SPC 3

4.2.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 3

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 for Meta SPC 3

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

see general directions for use for Meta SPC 3

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

see general directions for use for Meta SPC 3

5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3

5.1.   Instructions for use

Disinfection cycle:

Products must be diluted in potable water before use.

Final rinsing (with potable water): if required.

The surfaces to be disinfected must be wet enough in order to be kept wet during the approved contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”.

5.2.   Risk mitigation measures

Gloves and goggles are needed during mixing and loading of the concentrated products.

Wear protective coverall (to be specified by the authorisation holder within the product information).

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

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 ON SKIN: Immediately wash skin 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. Immediately call 112/ambulance for medical assistance.

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

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

The shelf-life of the products is two years.

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)

Concentrated Algaecide

Market area: EU

 

Kenosan Lactic CONC

Market area: EU

Authorisation number

EU-0027740-0003 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

70,0

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

6,0

META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

Identifier

Meta SPC 4: Concentrated surface disinfectants for sanitary hygiene and kitchens (PT2-PT4)

1.2.   Suffix to the authorisation number

Number

1-4

1.3.   Product type(s)

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

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

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

16,0

16,0

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

5,0

5,0

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

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements

Causes skin irritation.

Causes serious eye damage.

Contains eucalyptus globulus oil (CAS-No 8000-48-4). May produce an allergic reaction.

Precautionary statements

If medical advice is needed, have product container or label at hand.

Keep out of reach of children.

Read carefully and follow all instructions.

Wash hands thoroughly after handling.

Wear protective gloves.

Wear eyes/face protection.

IF ON SKIN:Wash with plenty of 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.

If skin irritation occurs:Get medical advice.

Take off contaminated clothing.And wash it before reuse.

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

4.1.   Use description

Table 6

Use # 1 – Hard surface disinfection for sanitary hygiene, other than in healthcare, for professional use (PT2)

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Public field (NOT in HEALTHCARE)

Disinfection of hard/non-porous surfaces (for sanitary hygiene) by spraying without prior cleaning

Application method(s)

Method: By spraying (with wiping if needed, only after the end of the preconised contact time)

Detailed description:

/

Application rate(s) and frequency

Application Rate: 250 mL/m2 diluted product

Dilution (%): 20 %

Number and timing of application:

Active against bacteria and yeasts at room temperature

Dilute the product 20 % in water, to reach an in use concentration of 3,2 % Lactic acid.

In 15 minutes contact time

250 mL/m2 diluted product

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.1.1.   Use-specific instructions for use

Comply with the instructions for use

4.1.2.   Use-specific risk mitigation measures

Gloves and goggles are needed during handling of the products

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 for Meta SPC 4

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

see general directions for use for Meta SPC 4

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

see general directions for use for Meta SPC 4

4.2.   Use description

Table 7

Use # 2 – Hard surface disinfection for hygiene in kitchens, for professional use (PT4)

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

in food/feed areas:

Disinfection of hard/non-porous surfaces (for general hygiene) by spraying without prior cleaning

Application method(s)

Method: By spraying (with wiping if needed, only after the end of the preconised contact time)

Detailed description:

/

Application rate(s) and frequency

Application Rate: 100 mL/m2

Dilution (%): 20 %

Number and timing of application:

Active against bacteria and yeasts at room temperature

Dilute the product 20 % in water, to reach an in use concentration of 3,2 % Lactic acid.

In 15 minutes contact time

100 mL/m2

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.2.1.   Use-specific instructions for use

Comply with the instructions for use

4.2.2.   Use-specific risk mitigation measures

Gloves and goggles are needed during handling of the products.

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 for Meta SPC 4

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

see general directions for use for Meta SPC 4

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 for Meta SPC 4

4.3.   Use description

Table 8

Use # 3 – Disinfection of toilet bowls, for professional use (PT2)

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Public field

Disinfection of hard/non-porous inside surfaces of toilets, without prior cleaning

Application method(s)

Method: By pouring (with brushing – only after the end of the preconised contact time)

Detailed description:

/

Application rate(s) and frequency

Application Rate: 250 mL/m2

Dilution (%): -

Number and timing of application:

Active against bacteria and yeasts at room temperature:

With the undiluted product (with 16 % Lactic acid)

In five minutes contact time

Category(ies) of users

Professional

Pack sizes and packaging material

500 mL, 700 mL, 750 mL, 1L, 1.5 L, 2 L

HDPE (High Density Polyethylene)

Toilet Duck

4.3.1.   Use-specific instructions for use

Comply with the instructions for use

4.3.2.   Use-specific risk mitigation measures

Gloves and goggles are needed during handling of the products.

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 for Meta SPC 4

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

see general directions for use for Meta SPC 4

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 for Meta SPC 4

4.4.   Use description

Table 9

Use # 4 – Disinfection of toilet bowls, for non-professional use (PT2)

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Public field

Disinfection of hard/non-porous inside surfaces of toilets, without prior cleaning

Application method(s)

Method: By pouring (with brushing – only after the end of the preconised contact time)

Detailed description:

/

Application rate(s) and frequency

Application Rate: 250 mL/m2

Dilution (%): -

Number and timing of application:

Active against bacteria and yeasts at room temperature:

With the undiluted product (with 16 % Lactic acid)

In five minutes contact time

Category(ies) of users

General public (non-professional)

Pack sizes and packaging material

500 mL, 700 mL, 750 mL, 1L, 1.5 L, 2 L

HDPE (High Density Polyethylene)

Toilet Duck

4.4.1.   Use-specific instructions for use

Comply with the instructions for use

4.4.2.   Use-specific risk mitigation measures

Avoid contact with eyes

A child proof closure is required

The product must be fitted with a pouring spout, the product must be poured gently on the wall of the toilet bowl to avoid the formation of splashes.

Wash hands after application

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

If medical advice is needed, have product container or label at hand

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

see general directions for use for Meta SPC 4

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

Keep out of reach of children and non-target animals/pets.

5.   GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4

5.1.   Instructions for use

The surfaces to be disinfected must be wet enough in order to be kept wet during the preconised contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”.

5.2.   Risk mitigation measures

/

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

IF ON SKIN: Immediately wash skin 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 skin irritation occurs: Get medical advice.

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. Immediately call 112/ambulance for medical assistance.

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

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

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

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

The shelf-life of the products is two years.

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)

Sanifresh

Market area: EU

 

Milcho Des

Market area: EU

Kenolens

Market area: EU

Kenolux S100

Market area: EU

SANI-CAL

Market area: EU

Sani Super

Market area: EU

Scrub

Market area: EU

MiQro Sani Des

Market area: EU

Authorisation number

EU-0027740-0004 1-4

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

16,0

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

5,0

META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 5 identifier

Identifier

Meta SPC 5: Concentrated pre-dips (PT3)

1.2.   Suffix to the authorisation number

Number

1-5

1.3.   Product type(s)

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

2.   META SPC 5 COMPOSITION

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

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

8,0

8,0

Sodium lauryl ether sulfate

Alcohols, C12-14, ethoxylated, sulfates, sodium salts

Non-active substance

68891-38-3

500-234-8

8,4

8,4

Sulfonic acids, C14-17-sec-alkane, sodium salts

Sulfonic acids, C14-17-sec-alkane, sodium salts

Non-active substance

97489-15-1

307-055-2

2,25

2,25

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

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

Hazard statements

Causes serious eye damage.

Precautionary statements

Wear eyes/face protection.

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.

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

4.1.   Use description

Table 10

Use # 1 – Teat disinfection, before milking

Product type

PT03 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Veterinary field

Teat disinfection before milking with concentrated product (to be diluted before disinfection procedure), without prior cleaning

Application method(s)

Method: By dipping, by spraying with spray flacon or spray installation and by wiping with a towel

Detailed description:

By dipping

By spraying with spray flacon or spray installation

By wiping with a towel soaking with the diluted product

Application rate(s) and frequency

Application Rate: 5 – 15 mL

Dilution (%): 40 %

Number and timing of application:

Active against bacteria and yeasts:

Dilution: 40 %

The product must be diluted with RT potable water.

In one minute contact time

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.1.1.   Use-specific instructions for use

Application rates:

Dilution: 40 % (with 3,2 % LA) – The product must be diluted with RT potable water.

5 mL per cow per application for use by dipping

7.5 mL per cow per application for use by spray flacon

15 mL per cow per application for use by spray installation

For use by wiping with a towel: prepare 10 L working solution for 25 towels.

Use one towel per cow.

4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 5

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

see general directions for use for Meta SPC 5

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

see general directions for use for Meta SPC 5

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

see general directions for use for Meta SPC 5

4.2.   Use description

Table 11

Use # 2 – Intact skin wash/disinfection (of the udder of dairy and beef cattle before calving and of the udder of sows before farrowing)

Product type

PT03 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Veterinary field

Application method(s)

Method: Spraying

Detailed description:

/

Application rate(s) and frequency

Application Rate: 5 – 20 mL

Dilution (%): 40 %

Number and timing of application:

Active against bacteria and yeasts:

Dilution: 40 %

The product must be diluted with Room Temperature potable water.

In one minute contact time

1)

dairy and beef cattle on the udder before calving: 5 mL (1 spray) on each teat

2)

sows on the udder before farrowing: 20 mL

The animals should be kept standing on a clean floor for at least five minutes.

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.2.1.   Use-specific instructions for use

see general directions for use for Meta SPC 5

4.2.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 5

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 for Meta SPC 5

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

see general directions for use for Meta SPC 5

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 for Meta SPC 5

5.   GENERAL DIRECTIONS FOR USE (5) OF THE META SPC 5

5.1.   Instructions for use

See use specific instructions for use

5.2.   Risk mitigation measures

Chemical goggles need to be worn.

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

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. Immediately call 112/ambulance for medical assistance.

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.

IF ON SKIN: Immediately wash skin 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 INHALED: If symptoms occur call a POISON CENTRE or a doctor.

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

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

The shelf-life of the products is two years.

6.   OTHER INFORMATION

/

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5

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

Trade name(s)

Kenopro Lactic

Market area: EU

 

HCP Foam Concentrate

Market area: EU

Kenopro Lactic

Market area: EU

Reconet+

Market area: EU

Kenopure

Market area: EU

MIROX Pre Lac

Market area: EU

Milchsäure Pre

Market area: EU

Milchsäure Pref

Market area: EU

Lactocid Pre

Market area: EU

Milcho Pre

Market area: EU

Preactive

Market area: EU

Precoop

Market area: EU

Lactipré

Market area: EU

Prelacti

Market area: EU

Prelak

Market area: EU

Power Prep

Market area: EU

Multicleaner

Market area: EU

Kenopure Strong

Market area: EU

Semex Pre

Market area: EU

MEPA Pure

Market area: EU

MEPA Foam

Market area: EU

Eco Lac Foam

Market area: EU

Authorisation number

EU-0027740-0005 1-5

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

8,0

Sodium lauryl ether sulfate

Alcohols, C12-14, ethoxylated, sulfates, sodium salts

Non-active substance

68891-38-3

500-234-8

8,4

Sulfonic acids, C14-17-sec-alkane, sodium salts

Sulfonic acids, C14-17-sec-alkane, sodium salts

Non-active substance

97489-15-1

307-055-2

2,25

META SPC 6

1.   META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 6 identifier

Identifier

Meta SPC 6: Ready to use Pre-dips (PT3)

1.2.   Suffix to the authorisation number

Number

1-6

1.3.   Product type(s)

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

2.   META SPC 6 COMPOSITION

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

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

3,6

3,6

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

5,25

5,25

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

Formulation(s)

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

Hazard statements

Causes serious eye damage.

Precautionary statements

Wear eye/face protection.

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.

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

4.1.   Use description

Table 12

Use # 1 – Teat disinfection, before milking

Product type

PT03 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Veterinary field

Application method(s)

Method: By dipping, by spraying with spray flacon or spray installation, by wiping with a towel

Detailed description:

 

By dipping

 

By spraying with spray flacon or spray installation

 

By wiping with a towel soaking with the diluted product

Application rate(s) and frequency

Application Rate: Active against bacteria and yeasts: (Ready-To-Use) RTU In one minute contact time. The product must “return” to room temperature before use.

Dilution (%): -

Number and timing of application:

Active against bacteria and yeasts:

RTU (with 3,6 % Lactic acid)

In one minute contact time

The product must “return” to RT before use

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.1.1.   Use-specific instructions for use

Application rates:

5 mL per cow per application for use by dipping

7,5 mL per cow per application for use by spray flacon

15 mL per cow per application for use by spray installation

One towel per cow for use by wiping

4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 6

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

see general directions for use for Meta SPC 6

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

see general directions for use for Meta SPC 6

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

see general directions for use for Meta SPC 6

5.   GENERAL DIRECTIONS FOR USE (6) OF THE META SPC 6

5.1.   Instructions for use

/

5.2.   Risk mitigation measures

Chemical goggles need to be worn.

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

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. Immediately call 112/ambulance for medical assistance.

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.

IF ON SKIN: Immediately wash skin 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 INHALED: If symptoms occur call a POISON CENTRE or a doctor.

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

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

The shelf-life of the products is two years.

6.   OTHER INFORMATION

/

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6

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

Trade name(s)

Kenopure R

Market area: EU

 

Kenopure RTU

Market area: EU

HCP Foam RTU

Market area: EU

Kenoxypure RTU

Market area: EU

Kenopurox RTU

Market area: EU

Kenopure Ox RTU

Market area: EU

Kenopure Plus RTU

Market area: EU

Kenopure Extra RTU

Market area: EU

Kenopure oxylac RTU

Market area: EU

Kenoxylac predip RTU

Market area: EU

Kenoxilac predip RTU

Market area: EU

Kenopure H2O2 RTU

Market area: EU

Oxy Kenopure RTU

Market area: EU

Preactive RTU

Market area: EU

Precoop RTU

Market area: EU

Lactipré RTU

Market area: EU

Prelacti RTU

Market area: EU

Prelak RTU

Market area: EU

Power Prep RTU

Market area: EU

Prelacta Foam

Market area: EU

Authorisation number

EU-0027740-0006 1-6

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

3,6

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

5,25

META SPC 7

1.   META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 7 identifier

Identifier

Meta SPC 7: Ready to use wipes (PT2, PT4)

1.2.   Suffix to the authorisation number

Number

1-7

1.3.   Product type(s)

Product type(s)

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 – Food and feed area (Disinfectants)

2.   META SPC 7 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 7

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

2,0

2,0

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

0,6

0,9

2.2.   Type(s) of formulation of the meta SPC 7

Formulation(s)

WI – Wipes

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

Hazard statements

Causes serious eye irritation.

Precautionary statements

If medical advice is needed, have product container or label at hand.

Keep out of reach of children.

Read carefully and follow all instructions.

Wash hands thoroughly after handling.

Wear eyes/face protection.

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

If skin irritation occurs:Get medical advice.

If eye irritation persists:Get medical advice.

Take off contaminated clothing.And wash it before reuse.

4.   AUTHORISED USE(S) OF THE META SPC 7

4.1.   Use description

Table 13

Use # 1 – Hard surface disinfection in Food and Feed industry, for professional use (PT4)

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeasts

Common name: Yeasts

Development stage:

Scientific name: other: viruses

Common name: Viruses

Development stage:

Field(s) of use

Indoor

Food/feed areas

Disinfection of hard/non-porous surfaces and objects, with prior cleaning

Application method(s)

Method: With pre-impragnated wipes

Detailed description:

/

Application rate(s) and frequency

Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time

Dilution (%): -

Number and timing of application:

Active against bacteria, yeasts and viruses:

With pre-impregnated wipes

at room temperature in two minutes contact time

Category(ies) of users

Professional

Pack sizes and packaging material

Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes

4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 7

4.1.2.   Use-specific risk mitigation measures

/

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 for Meta SPC 7

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

see general directions for use for Meta SPC 7

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 for Meta SPC 7

4.2.   Use description

Table 14

Use # 2 – Hard surface disinfection in food and feed area, for non-professional use (PT4)

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeasts

Common name: Yeasts

Development stage:

Scientific name: other: viruses

Common name: Viruses

Development stage:

Field(s) of use

Indoor

Food/feed areas

Disinfection of hard/non-porous surfaces and objects, with prior cleaning

Application method(s)

Method: With pre-impragnated wipes

Detailed description:

Wipes

Application rate(s) and frequency

Application Rate: One wipe/m2

Dilution (%): -

Number and timing of application:

Active against bacteria, yeasts and viruses:

With pre-impregnated wipes

at room temperature in two minutes contact time

Category(ies) of users

General public (non-professional)

Pack sizes and packaging material

Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes

4.2.1.   Use-specific instructions for use

Comply with the instructions for use

4.2.2.   Use-specific risk mitigation measures

/

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

If medical advice is needed, have product container or label at hand

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

see general directions for use for Meta SPC 7

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

Keep out of reach of children and non-target animals/pets.

4.3.   Use description

Table 15

Use # 3 – Hard surface disinfection, use in healthcare, for professional use (PT2)

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeasts

Common name: Yeasts

Development stage:

Scientific name: other: viruses

Common name: Viruses

Development stage:

Field(s) of use

Indoor

Public field:

Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) with prior cleaning

Application method(s)

Method: With pre-impregnated wipes

Detailed description:

/

Application rate(s) and frequency

Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time

Dilution (%): -

Number and timing of application:

Active against bacteria, yeasts and viruses:

With pre-impregnated wipes

at room temperature in two minutes contact time

Category(ies) of users

Professional

Pack sizes and packaging material

Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes

4.3.1.   Use-specific instructions for use

see general directions for use for Meta SPC 7

4.3.2.   Use-specific risk mitigation measures

/

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 for Meta SPC 7

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

see general directions for use for Meta SPC 7

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 for Meta SPC 7

4.4.   Use description

Table 16

Use # 4 – Hard surface disinfection, use in healthcare, for non-professional use (PT2)

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeasts

Common name: Yeasts

Development stage:

Scientific name: other: viruses

Common name: Viruses

Development stage:

Field(s) of use

Indoor

Public field: Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) in healthcare area with prior cleaning

Application method(s)

Method: With pre-impregnated wipes

Detailed description:

/

Application rate(s) and frequency

Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time

Dilution (%): -

Number and timing of application:

Active against bacteria, yeasts and viruses:

With pre-impregnated wipes

at room temperature in two minutes contact time

Category(ies) of users

General public (non-professional)

Pack sizes and packaging material

Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes

4.4.1.   Use-specific instructions for use

Comply with the instructions for use

4.4.2.   Use-specific risk mitigation measures

/

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

If medical advice is needed, have product container or label at hand

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

see general directions for use for Meta SPC 7

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

Keep out of reach of children and non-target animals/pets.

4.5.   Use description

Table 17

Use # 5 – Hard surface disinfection, use other than in healthcare, for professional use (PT2)

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeasts

Common name: Yeasts

Development stage:

Scientific name: other: viruses

Common name: Viruses

Development stage:

Field(s) of use

Indoor

Public field:

Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) with prior cleaning

Application method(s)

Method: With pre-impregnated wipes

Detailed description:

/

Application rate(s) and frequency

Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time

Dilution (%): -

Number and timing of application:

Active against bacteria, yeasts and viruse:

With pre-impregnated wipes

at room temperature in two minutes contact time

Category(ies) of users

Professional

Pack sizes and packaging material

Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes

4.5.1.   Use-specific instructions for use

see general directions for use for Meta SPC 7

4.5.2.   Use-specific risk mitigation measures

/

4.5.3.   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 for Meta SPC 7

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

see general directions for use for Meta SPC 7

4.5.5.   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 for Meta SPC 7

4.6.   Use description

Table 18

Use # 6 – Hard surface disinfection, use other than in healthcare, for non-professional use (PT2)

Product type

PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeasts

Common name: Yeasts

Development stage:

Scientific name: other: viruses

Common name: Viruses

Development stage:

Field(s) of use

Indoor

Public field:

Disinfection of hard/non-porous surfaces (walls, floors and other surfaces in indoor spaces, including bathrooms and toilets) with prior cleaning

Application method(s)

Method: With pre-impregnated wipes

Detailed description:

/

Application rate(s) and frequency

Application Rate: Active against bacteria, yeasts and viruses: With pre-impregnated wipes at room temperature in two minutes contact time

Dilution (%): -

Number and timing of application:

Active against bacteria, yeasts and viruses:

With pre-impregnated wipes

at room temperature in two minutes contact time

Category(ies) of users

General public (non-professional)

Pack sizes and packaging material

Box in HDPE with lid in HDPE with 200 wipes, 280 wipes, 500 wipes

4.6.1.   Use-specific instructions for use

Comply with the instructions for use

4.6.2.   Use-specific risk mitigation measures

/

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

If medical advice is needed, have product container or label at hand.

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

see general directions for use for Meta SPC 7

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

Keep out of reach of children and non-target animals/pets.

5.   GENERAL DIRECTIONS FOR USE (7) OF THE META SPC 7

5.1.   Instructions for use

Comply with the instructions for use

First clean thoroughly the surfaces and materials to be disinfected and dry the surface or materials.

Disinfect the dry surface with a wipe. Make sure the surface remains completely wetted during the required contact time.

5.2.   Risk mitigation measures

/

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

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.

IF IN EYES: Rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for five minutes. 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.

If medical advice is needed, have product container or label at hand

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

The packing and content must be eliminated as dangerous waste product under the fullresponsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use. Store at ambient temperature. Do not store below 0 °C and above 40 °C.

The shelf-life of the products is two years.

Keep out of reach of children and non-target animals/pets

6.   OTHER INFORMATION

/

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7

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

Trade name(s)

Kenopure wipes

Market area: EU

 

EP-460 Wipes

Market area: EU

Sani Wipes

Market area: EU

Lactides Wipes

Market area: EU

Keno Lac Wipes

Market area: EU

KL Wipes

Market area: EU

Kenolux Wipes

Market area: EU

Power Des Wipes

Market area: EU

Keno L Wipes

Market area: EU

Keno Des Wipes

Market area: EU

RĘCZNIKI PAPIEROWE MYJĄCO-DEZYNFEKUJĄCE FARMA

Market area: EU

RĘCZNIKI PAPIEROWE MYJĄCO-DEZYNFEKUJĄCE VITTRA

Market area: EU

Ręczniki myjąco-dezynfekujące AGROD

Market area: EU

Authorisation number

EU-0027740-0007 1-7

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

2,0

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

0,6

META SPC 8

1.   META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 8 identifier

Identifier

Meta SPC 8: Ready to use post-dips by dipping (PT3)

1.2.   Suffix to the authorisation number

Number

1-8

1.3.   Product type(s)

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

2.   META SPC 8 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

3,6

7,5

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

1,3

1,3

Isopropanol

Propan-2-ol

Non-active substance

67-63-0

200-661-7

1,0

3,0

2.2.   Type(s) of formulation of the meta SPC 8

Formulation(s)

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

Hazard statements

Causes serious eye damage.

Precautionary statements

Wear eyes/face protection.

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.

4.   AUTHORISED USE(S) OF THE META SPC 8

4.1.   Use description

Table 19

Use # 1 – Teat disinfection after milking by dipping

Product type

PT03 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Veterinary field:

(Ready-To-Use) RTU post-dip for teat disinfection, after milking, without prior cleaning

Application method(s)

Method: By dipping

Detailed description:

/

Application rate(s) and frequency

Application Rate: Active against bacteria and yeasts: RTU In five minutes contact time. The product must “return” to RT before use.

Dilution (%): -

Number and timing of application:

Active against bacteria and yeasts:

RTU (with 3.6 – 7,5 % Lactic acid depending on the product considered)

In five minutes contact time

The product must “return” to room temperature before use

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 8

4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 8

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 for Meta SPC 8

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

see general directions for use for Meta SPC 8

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 for Meta SPC 8

5.   GENERAL DIRECTIONS FOR USE (8) OF THE META SPC 8

5.1.   Instructions for use

Apply the product immediately after each milking, two or three times per day. Ensure that the teat is completely covered to three quarter of its length. Fill the dipping cup with the desired amount of product, but do not use more fluid than necessary. Assume 5 mL per cow per treatment. Respect a contact time of five minutes. The product must be brought to a temperature above 20 °C before use. In order to ensure optimal teat disinfection, the animals should be kept standing for at least five minutes.

5.2.   Risk mitigation measures

Chemical goggles need to be worn.

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

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. Immediately call 112/ambulance for medical assistance.

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

IF ON SKIN: Immediately wash skin 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 INHALED: If symptoms occur call a POISON CENTRE or a doctor.

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

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

The shelf-life of the products is two years.

6.   OTHER INFORMATION

/

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8

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

Trade name(s)

Kenolac

Market area: EU

 

Kenolac Red

Market area: EU

Kenodip 200

Market area: EU

Stalosan Lac Dip

Market area: EU

HCP Dip

Market area: EU

PEZERK LV PLUS

Market area: EU

MIROX Dip Lac

Market area: EU

Milchsäure Dip

Market area: EU

Milchsäure Tauche

Market area: EU

Lactocid Dip

Market area: EU

GAHERLAC

Market area: EU

Lactidip

Market area: EU

Lacticoop

Market area: EU

Lactactiv

Market area: EU

Laktotop

Market area: EU

Superlac

Market area: EU

MilchsäureFilmdip Super

Market area: EU

MEPA Lac

Market area: EU

Eco Lac

Market area: EU

BluGard Dip

Market area: EU

Blu-Gard Dip

Market area: EU

Authorisation number

EU-0027740-0008 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

3,6

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

1,3

Isopropanol

Propan-2-ol

Non-active substance

67-63-0

200-661-7

1,0

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

Trade name(s)

Kenolac Forte W

Market area: EU

Authorisation number

EU-0027740-0009 1-8

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

7,5

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

1,3

Isopropanol

Propan-2-ol

Non-active substance

67-63-0

200-661-7

3,0

META SPC 9

1.   META SPC 9 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 9 identifier

Identifier

Meta SPC 9: Ready to use post-dips by spraying (PT3)

1.2.   Suffix to the authorisation number

Number

1-9

1.3.   Product type(s)

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

2.   META SPC 9 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 9

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

3,6

7,5

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

0,5

1,3

Isopropanol

Propan-2-ol

Non-active substance

67-63-0

200-661-7

3,0

3,0

2.2.   Type(s) of formulation of the meta SPC 9

Formulation(s)

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9

Hazard statements

Causes serious eye damage.

Precautionary statements

Wear eye/face protection.

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.

4.   AUTHORISED USE(S) OF THE META SPC 9

4.1.   Use description

Table 20

Use # 1 – Teat disinfection after milking by spraying or dipping

Product type

PT03 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Veterinary field:

RTU spray or dip for teat disinfection, after milking, without prior cleaning

Application method(s)

Method: by spraying or dipping

Detailed description:

By spraying or dipping

Application rate(s) and frequency

Application Rate: Active against bacteria and yeasts: RTU In five minutes contact time. The product must “return” to RT before use.

Dilution (%): -

Number and timing of application:

Active against bacteria and yeasts:

RTU (with 3.6 – 7,5 % Lactic acid depending on the product considered)

In five minutes contact time

The product must return to Room temperature before use

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 9

4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 9

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 for Meta SPC 9

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

see general directions for use for Meta SPC 9

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 for Meta SPC 9

5.   GENERAL DIRECTIONS FOR USE (9) OF THE META SPC 9

5.1.   Instructions for use

Apply the product immediately after each milking, two or three times per day. Ensure that the teat is completely covered to three quarter of its length. Fill the dipping cup or spraying flacon with the desired amount of the product, but do not use more fluid that necessary. Assume 5 mL per cow per treatment. Respect a contact time of five minutes.

The product must be brought to a temperature above 20 °C before use.

In order to ensure optimal teat disinfection, the animals should be kept standing for at least five minutes.

5.2.   Risk mitigation measures

Chemical goggles need to be worn.

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

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. Immediately call 112/ambulance for medical assistance.

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

IF ON SKIN: Immediately wash skin 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 INHALED: If symptoms occur call a POISON CENTRE or a doctor.

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

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

The shelf-life of the products is two years.

6.   OTHER INFORMATION

/

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9

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

Trade name(s)

Kenolac SD

Market area: EU

 

HCP Spray

Market area: EU

Lactospray

Market area: EU

Zitzentop

Market area: EU

Lactosilk

Market area: EU

Milchsäure Spray Bühning

Market area: EU

Lacto SP

Market area: EU

Stalosan Lac Spray

Market area: EU

MIROX Spray Lac

Market area: EU

Milchsäure Sprühe

Market area: EU

Lactocid Spray

Market area: EU

Milcho Spray

Market area: EU

GAHERLAC SPRAY

Market area: EU

Lactispray

Market area: EU

Lacticoop Spray

Market area: EU

Lactactiv Spray

Market area: EU

Laktotop Spray

Market area: EU

Superlac Spray

Market area: EU

Robolac

Market area: EU

MEPA Lac SD

Market area: EU

Eco Lac SD

Market area: EU

Lely Quaress Circum

Market area: EU

BluGard Spray

Market area: EU

Blu-Gard Spray

Market area: EU

Authorisation number

EU-0027740-0010 1-9

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

3,6

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

1,3

Isopropanol

Propan-2-ol

Non-active substance

67-63-0

200-661-7

3,0

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

Trade name(s)

Kenolac Forte SD

Market area: EU

Authorisation number

EU-0027740-0011 1-9

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

7,5

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

1,3

Isopropanol

Propan-2-ol

Non-active substance

67-63-0

200-661-7

3,0

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

Trade name(s)

Valiant ULTRA EVERYDAY

Market area: EU

Authorisation number

EU-0027740-0018 1-9

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

4,0

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

1,3

Isopropanol

Propan-2-ol

Non-active substance

67-63-0

200-661-7

3,0

META SPC 10

1.   META SPC 10 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 10 identifier

Identifier

Meta SPC 10: Ready to use post-dips by spraying and dipping (PT3)

1.2.   Suffix to the authorisation number

Number

1-10

1.3.   Product type(s)

Product type(s)

PT03 – Veterinary hygiene (Disinfectants)

2.   META SPC 10 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 10

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

3,6

3,6

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

0,05

0,05

2.2.   Type(s) of formulation of the meta SPC 10

Formulation(s)

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 10

Hazard statements

Flammable liquid and vapour.

Causes serious eye damage.

Contains menthan-3-one (CAS-No 14073-97-3). May produce an allergic reaction.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.

Wear eyes/face protection.

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.

In case of fire:Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide to extinguish.

Store in a well-ventilated place.Keep cool.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 10

4.1.   Use description

Table 21

Use # 1 – Teat disinfection after milking by spraying or dipping

Product type

PT03 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Veterinary field:

RTU spray/dip for teat disinfection, after milking, without prior cleaning

Application method(s)

Method: By spraying or dipping

Detailed description:

/

Application rate(s) and frequency

Application Rate: Active against bacteria and yeasts: RTU In five minutes contact time. The product must “return” to RT before use

Dilution (%): -

Number and timing of application:

Active against bacteria and yeasts:

RTU (with 3,6 % Lactic acid)

In five minutes contact time

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.1.1.   Use-specific instructions for use

Application rates:

7.5 mL per cow working solution for use by spraying with flacon

15 mL per cow working solution for use by spraying in installation

15 mL per cow by for use by spraying with robot

2.5-5 mL per cow for use by dipping/foaming

4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 10

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 for Meta SPC 10

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

see general directions for use for Meta SPC 10

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 for Meta SPC 10

5.   GENERAL DIRECTIONS FOR USE (10) OF THE META SPC 10

5.1.   Instructions for use

Apply the product immediately after each milking, two or three times per day. Ensure that the teat is completely covered to three quarter of its length. Fill the dipping cup or spraying flacon with the desired amount of product, but do not use more fluid that necessary. The product must be brought to a temperature above 20 °C before use.

In order to ensure optimal teat disinfection, the animals should be kept standing for at least five minutes.

5.2.   Risk mitigation measures

Chemical goggles need to be worn.

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

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

IF ON SKIN: Immediately wash skin 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 skin irritation occurs: Get medical advice.

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. Immediately call 112/ambulance for medical assistance.

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

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

The shelf-life of the products is two years.

6.   OTHER INFORMATION

/

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 10

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

Trade name(s)

Kenocool

Market area: EU

 

PEZERK LI PLUS

Market area: EU

Milcho Dip

Market area: EU

Authorisation number

EU-0027740-0012 1-10

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

3,6

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

0,05

META SPC 11

1.   META SPC 11 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 11 identifier

Identifier

Meta SPC 11: Concentrated Surface and equipment disinfectants (PT3 and PT4)

1.2.   Suffix to the authorisation number

Number

1-11

1.3.   Product type(s)

Product type(s)

PT04 – Food and feed area (Disinfectants)

PT03 – Veterinary hygiene (Disinfectants)

2.   META SPC 11 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 11

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

24,0

24,0

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

12,0

12,0

Isopropanol

Propan-2-ol

Non-active substance

67-63-0

200-661-7

5,0

5,0

2.2.   Type(s) of formulation of the meta SPC 11

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 11

Hazard statements

Causes skin irritation.

Causes serious eye damage.

Precautionary statements

Wash hands thoroughly after handling.

Wear protective gloves.

Wear eyes/face protection.

IF ON SKIN:Wash with plenty of 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.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 11

4.1.   Use description

Table 22

Use # 1 – Hard surface disinfection in food and feed industry

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

in Food/feed industry + Public field:

Disinfection of hard/non-porous surfaces by spraying or soaking with prior cleaning

Application method(s)

Method: By spraying or by immersion

Detailed description:

Spraying

Immersion (the bath is intended to be used only once)

Application rate(s) and frequency

Application Rate: 100 mL/m2

Dilution (%): 1 % or 3 %

Number and timing of application:

Active against bacteria and yeasts at room temperature:

3 % (with 0,72 % Lactic acid) in two minutes contact time

1 % (with 0,24 % Lactic acid) in 15 minutes contact time

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 11

4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 11

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 for Meta SPC 11

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

see general directions for use for Meta SPC 11

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 for Meta SPC 11

4.2.   Use description

Table 23

Use # 2 – Equipment disinfection by soaking in food and feed industry

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Indoor – in Food/feed industry + Public field:

Disinfection of hard/non-porous surfaces (for example processing machines) by spraying or soaking without prior cleaning

Application method(s)

Method: By spraying or immersion

Detailed description:

/

Application rate(s) and frequency

Application Rate: 100 mL/m2

Dilution (%): 8 % or 15 %

Number and timing of application:

Active against bacteria and yeasts at +7 °C:

By soaking: 15 % (with 3,6 % Lactic acid) in 30 seconds contact time

By spraying: 8 % (with 1,92 % Lactic acid) in two minutes contact time

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.2.1.   Use-specific instructions for use

see general directions for use for Meta SPC 11

4.2.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 11

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 for Meta SPC 11

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

see general directions for use for Meta SPC 11

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 for Meta SPC 11

4.3.   Use description

Table 24

Use # 3 – Hard surface disinfection for veterinary hygiene

Product type

PT03 – Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Veterinary field:

Disinfection of hard/non-porous surfaces by spraying or soaking with prior cleaning

Application method(s)

Method: By spraying or immersion

Detailed description:

Spraying

Immersion (the bath is intended to be used only once)

Application rate(s) and frequency

Application Rate: Active against bacteria and yeasts at +10 °C: 4 % in 30 minutes contact time

Dilution (%): 4 %

Number and timing of application:

Active against bacteria and yeasts at +10 °C:

4 % (with 0,96 % Lactic acid) in 30 minutes contact time

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.3.1.   Use-specific instructions for use

Animal houses must be empty of animals during disinfection. The product is used to disinfect animal housings of pigs, cows, poultry. Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.

Mixing and loading: container is opened manually and emptied into the reservoir or connected to a pump, which pumps the product into the reservoir of the spraying device which is then filled up with water in order to achieve the correct concentration of use. Apply the product by spraying or immersion. Use as much solution as needed to keep the surfaces wet during the complete contact time. It is not necessary to spray during the complete contact time.

4.3.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 11

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 for Meta SPC 11

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

see general directions for use for Meta SPC 11

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 for Meta SPC 11

5.   GENERAL DIRECTIONS FOR USE (11) OF THE META SPC 11

5.1.   Instructions for use

Disinfection procedures by spraying: The surfaces to be disinfected must be wet enough in order to be kept wet during the preconised contact time for optimal disinfection. The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”.

Products must be diluted in potable water before use.

5.2.   Risk mitigation measures

Gloves and goggles are needed during mixing and loading.

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

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.

IF ON SKIN: Immediately wash skin 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 skin irritation occurs: Get medical advice.

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. Immediately call 112/ambulance for medical assistance.

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

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

The shelf-life of the products is two years.

6.   OTHER INFORMATION

/

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 11

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

Trade name(s)

Kenosan Lactic

Market area: EU

 

Lacto Des

Market area: EU

Bio Des 100

Market area: EU

Bio Lac

Market area: EU

Authorisation number

EU-0027740-0013 1-11

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

24,0

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

12,0

Isopropanol

Propan-2-ol

Non-active substance

67-63-0

200-661-7

5,0

META SPC 12

1.   META SPC 12 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 12 identifier

Identifier

Meta SPC 12: Inner surface disinfectants by CIP with and without circulation and crate wash (PT4)

1.2.   Suffix to the authorisation number

Number

1-12

1.3.   Product type(s)

Product type(s)

PT04 – Food and feed area (Disinfectants)

2.   META SPC 12 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 12

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

22,0

22,0

C6 alkyl glucoside

Hexyl D-Glucoside

Non-active substance

54549-24-5

259-217-6

2,4

2,4

Methanesulfonic acid

Methanesulfonic acid

Non-active substance

75-75-2

200-898-6

0,0

10,5

Sulphuric acid

Sulphuric acid

Non-active substance

7664-93-9

231-639-5

0,0

10,5

2.2.   Type(s) of formulation of the meta SPC 12

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 12

Hazard statements

Causes severe skin burns and eye damage.

May be corrosive to metals.

Precautionary statements

Keep only in original packaging.

Do not breathe vapours.

Wash hands thoroughly after handling.

Wear protective gloves.

Wear protective clothing.

Wear eyes/face protection.

IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.

IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.

IF INHALED:Remove person to fresh air and keep comfortable for breathing.

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.

Absorb spillage to prevent material damage.

Wash contaminated clothing before reuse.

Store locked up.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 12

4.1.   Use description

Table 25

Use # 1 – Inner surface disinfection by CIP with circulation

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

in Food and feed industry:

Disinfection of hard/non-porous inner surfaces by CIP procedures (with circulation)

Application method(s)

Method: CIP procedures

Detailed description:

/

Application rate(s) and frequency

Application Rate: at +50 °C

Dilution (%): 1 to 4 %

Number and timing of application:

At +50 °C

Active against bacteria and yeasts:

with prior cleaning: 2 % (with 0,44 % Lactic acid) in two minutes contact time/1 % in 30 minutes contact time

without prior cleaning: 4 % (with 0,88 % Lactic acid) in two minutes contact time Or 1 % (0,22 % Lactic acid) in 30 minutes contact time

in milky conditions: 2 % (with 0,44 % Lactic acid) in 15 minutes contact time

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 12

4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 12

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 for Meta SPC 12

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

see general directions for use for Meta SPC 12

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 for Meta SPC 12

4.2.   Use description

Table 26

Use # 2 – Inner surface disinfection by CIP without circulation

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

in Food and feed industry:

Disinfection of hard/non-porous inner surfaces by CIP procedures (without circulation)

Application method(s)

Method: CIP procedures

Detailed description:

/

Application rate(s) and frequency

Application Rate: At +50 °C

Dilution (%): 2 % or 4 %

Number and timing of application:

At +50 °C

Active against bacteria and yeasts:

with prior cleaning: 2 % (with 0,44 % Lactic acid) in two minutes contact time

without prior cleaning: 4 % (with 0,88 % Lactic acid) in two minutes contact time Or 2 % (with 0,44 % Lactic acid) in 30 minutes contact time

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.2.1.   Use-specific instructions for use

see general directions for use for Meta SPC 12

4.2.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 12

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 for Meta SPC 12

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

see general directions for use for Meta SPC 12

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 for Meta SPC 12

4.3.   Use description

Table 27

Use # 3 – Crate wash

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Common name: Bacteria

Development stage:

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Indoor – in Food and feed industry

disinfection of hard/non-porous surfaces in crate washers

Application method(s)

Method: Crate wash

Detailed description:

/

Application rate(s) and frequency

Application Rate: At +50 °C

Dilution (%): 2 % or 4 %

Number and timing of application:

At +50 °C

Active against bacteria and yeasts:

With prior cleaning: 2 % (with 0,44 % Lactic acid) in two minutes contact

without prior cleaning: 4 % (with 0,88 % Lactic acid) in two minutes contact

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.3.1.   Use-specific instructions for use

see general directions for use for Meta SPC 12

4.3.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 12

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 for Meta SPC 12

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

see general directions for use for Meta SPC 12

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 for Meta SPC 12

5.   GENERAL DIRECTIONS FOR USE (12) OF THE META SPC 12

5.1.   Instructions for use

Products must be diluted in potable water before use.

5.2.   Risk mitigation measures

Gloves and goggles are needed during mixing and loading.

Wear protective coverall (to be specified by the authorisation holder within the product information).

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

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 ON SKIN: Immediately wash skin 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. Immediately call a Call 112/ambulance for medical assistance.

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

The packing and content must be eliminated as dangerous waste product under the whole responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

The shelf-life of the products is 2 years.

6.   OTHER INFORMATION

/

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 12

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

Trade name(s)

Pho Cid L

Market area: EU

 

Tornax 100

Market area: EU

Tornax Des

Market area: EU

Lacto CIP

Market area: EU

Pho Cid Eco

Market area: EU

Authorisation number

EU-0027740-0014 1-12

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

22,0

C6 alkyl glucoside

Hexyl D-Glucoside

Non-active substance

54549-24-5

259-217-6

2,4

Methanesulfonic acid

Methanesulfonic acid

Non-active substance

75-75-2

200-898-6

10,5

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

Trade name(s)

Pho Cid LS

Market area: EU

Authorisation number

EU-0027740-0015 1-12

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

22,0

C6 alkyl glucoside

Hexyl D-Glucoside

Non-active substance

54549-24-5

259-217-6

2,4

Sulphuric acid

Sulphuric acid

Non-active substance

7664-93-9

231-639-5

10,5

META SPC 13

1.   META SPC 13 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 13 identifier

Identifier

Meta SPC 13: Hard surface disinfectants (PT4)

1.2.   Suffix to the authorisation number

Number

1-13

1.3.   Product type(s)

Product type(s)

PT04 – Food and feed area (Disinfectants)

2.   META SPC 13 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 13

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

11,0

11,0

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

4,5

4,5

Methanesulfonic acid

Methanesulfonic acid

Non-active substance

75-75-2

200-898-6

10,5

19,5

2.2.   Type(s) of formulation of the meta SPC 13

Formulation(s)

SL – Soluble concentrate

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 13

Hazard statements

May be corrosive to metals.

Causes severe skin burns and eye damage.

Precautionary statements

Keep only in original packaging.

Do not breathe vapours.

Wash hands thoroughly after handling.

Wear protective gloves.

Wear protective clothing.

Wear eyes/face protection.

IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.

IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.

IF INHALED:Remove person to fresh air and keep comfortable for breathing.

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.

Absorb spillage to prevent material damage.

Wash contaminated clothing before reuse.

Store locked up.

Dispose of contents to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

Dispose of container to hazardous or special waste collection point, in accordance with local, regional, national and/or international regulation.

4.   AUTHORISED USE(S) OF THE META SPC 13

4.1.   Use description

Table 28

Use # 1 – Hard surface disinfection (PT4)

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

Food/feed areas

Disinfection of hard/non-porous surfaces by foaming

Application method(s)

Method: By foaming

Detailed description:

/

Application rate(s) and frequency

Application Rate: At room temperature in 30 minutes contact time Active against bacteria and yeasts: – with prior cleaning: 1 % – without prior cleaning: 5 %

Dilution (%): 1 or 5 %

Number and timing of application:

 

At room temperature in 30 minutes contact time

 

Active against bacteria and yeasts:

with prior cleaning: 1 % (with 0,11 % Lactic acid)

without prior cleaning: 5 % (with 0,55 % Lactic acid)

Category(ies) of users

Professional

Pack sizes and packaging material

1 L, 5 L, 10 L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

1 kg, 5 kg, 10 kg, 20 kg, 25 kg, 30 kg, 60 kg, 200 kg, 220 kg, 600 kg, 1 000 kg, 1 100 kg

HDPE (High Density Polyethylene)

4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 13

4.1.2.   Use-specific risk mitigation measures

see general directions for use for Meta SPC 13

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 for Meta SPC 13

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

see general directions for use for Meta SPC 13

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 for Meta SPC 13

5.   GENERAL DIRECTIONS FOR USE (13) OF THE META SPC 13

5.1.   Instructions for use

The surfaces to be disinfected must be wet enough in order to be kept wet during the preconised contact time for optimal disinfection.

The following precautionary sentence shall be added on the product label: “Make sure to wet surfaces completely”.

Products must be diluted in potable water before use.

5.2.   Risk mitigation measures

Gloves and goggles are needed during mixing and loading.

Wear protective coverall (to be specified by the authorisation holder within the product information).

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

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 ON SKIN: Immediately wash skin 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. Immediately call 112/ambulance for medical assistance.

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

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

The shelf-life of the products is two years.

6.   OTHER INFORMATION

/

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 13

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

Trade name(s)

Tornax L

Market area: EU

 

Lacto Cid

Market area: EU

Authorisation number

EU-0027740-0016 1-13

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

11,0

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

4,5

Methanesulfonic acid

Methanesulfonic acid

Non-active substance

75-75-2

200-898-6

10,5

META SPC 14

1.   META SPC 14 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 14 identifier

Identifier

Meta SPC 14: Ready to use hygienic handrub (PT1)

1.2.   Suffix to the authorisation number

Number

1-14

1.3.   Product type(s)

Product type(s)

PT01 – Human hygiene (Disinfectants)

2.   META SPC 14 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 14

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

3,6

3,6

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

2,0

2,0

Isopropanol

Propan-2-ol

Non-active substance

67-63-0

200-661-7

4,0

4,0

Butyldiglycol

2-(2-butoxyethoxy)ethanol

Non-active substance

112-34-5

203-961-6

10,0

10,0

2.2.   Type(s) of formulation of the meta SPC 14

Formulation(s)

AL – Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 14

Hazard statements

Causes serious eye damage.

Precautionary statements

Wear eye/face protection.

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.

4.   AUTHORISED USE(S) OF THE META SPC 14

4.1.   Use description

Table 29

Use # 1 – Hygienic handrub, for professional use (PT1)

Product type

PT01 – Human hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: other: bacteria

Common name: Bacteria

Development stage:

Scientific name: other: yeast

Common name: Yeasts

Development stage:

Field(s) of use

Indoor

in Food/feed industry; Public field; Kitchens

Hygienic handrub, on visibly clean hands

Application method(s)

Method: By rubbing the hands

Detailed description:

/

Application rate(s) and frequency

Application Rate: 6 mL of product

Dilution (%): -

Number and timing of application:

Active against bacteria and yeasts:

RTU (with 3,6 % Lactic acid)

6 mL (that is three pushes for both hands together)

One minute contact time

Category(ies) of users

Professional

Pack sizes and packaging material

50 mL, 75 mL, 100 mL, 150 mL, 500 mL, 1L, 5L, 10L, 20 L, 25 L, 30 L, 60 L, 200 L, 220 L, 600 L, 1 000 L, 1 100 L

HDPE (High Density Polyethylene)

4.1.1.   Use-specific instructions for use

see general directions for use for Meta SPC 14

4.1.2.   Use-specific risk mitigation measures

/

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 for Meta SPC 14

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

see general directions for use for Meta SPC 14

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 for Meta SPC 14

5.   GENERAL DIRECTIONS FOR USE (14) OF THE META SPC 14

5.1.   Instructions for use

Apply 6 ml of the product undiluted. Respect a contact time of 1 minute. Rinse thoroughly after disinfection.

For professional use only

5.2.   Risk mitigation measures

/

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

IF ON SKIN: Immediately wash skin 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 INHALED: If symptoms occur 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. Immediately call 112/ambulance for medical assistance.

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

The packing and content must be eliminated as dangerous waste product under the full responsibility of the possessor of this waste product. Do not throw wastes into sewers and watercourses. Dispose in a safe manner in accordance with local/national regulations.

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

The shelf-life of the products is two years.

6.   OTHER INFORMATION

/

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 14

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

Trade name(s)

Kenosan Hand Rub

Market area: EU

Authorisation number

EU-0027740-0017 1-14

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

 

Active Substance

79-33-4

201-196-2

3,6

Sodium Lauryl sulphate

Sulfuric acid, mono-C12-14-alkyl esters, sodium salts

Non-active substance

85586-07-8

287-809-4

2,0

Isopropanol

Propan-2-ol

Non-active substance

67-63-0

200-661-7

4,0

Butyldiglycol

2-(2-butoxyethoxy)ethanol

Non-active substance

112-34-5

203-961-6

10,0


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

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

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

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

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

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

(7)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.

(8)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.

(9)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 9.

(10)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 10.

(11)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 11.

(12)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 12.

(13)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 13.

(14)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 14.


ELI: http://data.europa.eu/eli/reg_impl/2023/2747/oj

ISSN 1977-0677 (electronic edition)


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