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’

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first paragraph, thereof,

Whereas:

(1) On 18 April 2019, CID Lines NV submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Lactic acid based products – CID Lines NV’ of product-types 1, 2, 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Belgium had agreed to evaluate the application. The application was recorded under case number BC-RC051007-54 in the Register for Biocidal Products.

(2) ‘Lactic acid based products – CID Lines NV’ contains L-(+)-lactic acid as the active substance, which is included in the Union list of approved active substance referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 1, 2, 3 and 4.

(3) On 23 June 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

(4) On 16 December 2021, the Agency submitted to the Commission an opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Lactic acid based products – CID Lines NV’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.

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

(6) On 11 January 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Lactic acid based products – CID Lines NV’.

(8) In its opinion, the Agency recommends that the authorisation holder should conduct a long-term storage stability test as a condition of the authorisation. The Commission agrees with that recommendation and considers that the submission of the results of that test should be a condition relating to the making available on the market and use of the biocidal product family pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of that Regulation on the basis of the existing data.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on biocidal products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0027740-0000 is 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’ subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II.

The Union Authorisation is valid from 1 September 2022 to 31 August 2032.

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, 26 July 2022.

For the Commission

The President

Ursula VON DER LEYEN

(1)

OJ L 167, 27.6.2012, p. 1

(2) ECHA opinion of 29 November 2021 on the Union authorisation of ‘Lactic acid based products – CID Lines NV’ (ECHA/BPC/299/2021), https://echa.europa.eu/bpc-opinions-on-union-authorisation

ANNEX I

TERMS AND CONDITIONS (EU-0027740-0000)

The authorisation holder shall 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. All relevant properties should be determined prior and after storage.

By 1 March 2023 the authorisation holder shall submit the results of the test to the Agency.

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)

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	1 September 2022
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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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

I – 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)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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/m

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

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)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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.

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 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

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)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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 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

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)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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 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

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)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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 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

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)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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-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 105 wipes, 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-impregnated 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 105 wipes, 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 105 wipes, 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 105 wipes, 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 105 wipes, 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 105 wipes, 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

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)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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 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

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)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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 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

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

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)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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 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

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)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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 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

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)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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 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)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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 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

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)

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 (%)
Common name	IUPAC name	Function	CAS number	EC number	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 INHALED: If symptoms occur call a POISON CENTRE or a doctor.

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

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

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.