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

Article 1

A Union authorisation with authorisation number EU-0021020-0000 is granted to HYPRED SAS for the making available on the market and use of the biocidal product family ‘HYPRED‘s octanoic acid based products’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 18 May 2020 until 30 April 2030.

Article 2

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

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

ANNEX

Summary of product characteristics for a biocidal product family

HYPRED‘s octanoic acid based products

Product type(s)

PT04: Food and feed area

Authorisation number EU-0021020-0000

R4BP asset number EU-0021020-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1.   Family name

Name	HYPRED‘s octanoic acid based products

1.2.   Product type(s)

Product type(s)	PT04: Food and feed area

1.3.   Authorisation holder

Name and address of the authorisation holder	Name	HYPRED SAS
Name and address of the authorisation holder	Address	55, boulevard Jules Verger 35803 DINARD FR
Authorisation number		EU-0021020-0000
R4BP asset number		EU-0021020-0000
Date of the authorisation		18 May 2020
Expiry date of the authorisation		30 April 2030

1.4.   Manufacturer(s) of the product

Name of manufacturer	HYPRED SAS
Address of manufacturer	55 Boulevard Jules Verger 35803 DINARD France
Location of manufacturing sites	HYPRED SAS site 1 HYPRED SAS - 55 Boulevard Jules Verger - BP 10180 35803 DINARD France HYPRED SAS site 2 KERSIA POLSKA Sp.z.o.o,. Niepruszewo, ul. Kasztanowa 4 64320 BUK Poland HYPRED SAS site 3 KERSIA IBERICA S.L Pol. Miguel Eguía C/Zarapuz s/n 31200 ESTELLA (NAVARRA) Spain HYPRED SAS site 4 KERSIA DEUTSCHLAND GmbH Marie-Curie-Straße 23 53332 BORNHEIM – SECHTEM Germany HYPRED SAS site 5 KERSIA ITALIA s.r.l. Strada Montodine-Gombito Loc. Cà Nova 26010 RIPALTA ARPINA (CR) Italy HYPRED SAS site 6 HYPRED SAS (KERSIA Group) - Zone Industrielle Le Roineau 72500 Vaas France HYPRED SAS site 7 KERSIA AUSTRIA GmbH - PFONGAUERSTRAßE 17 5202 NEUMARKT AM WALLERSEE Austria HYPRED SAS site 8 KERSIA DEUTSCHLAND GmbH - OBERBRÜHLSTRAßE 16-18 87700 MEMMINGEN Germany HYPRED SAS site 9 Kilco Holdings Ltd (KERSIA Group) - Broomhouses 2 Industrial Estate Old Glasgow Road DG11 2SD LOCKERBIE United Kingdom of Great Britain and Northern Ireland (the) HYPRED SAS site 10 Kilco (International) Ltd (KERSIA Group) - 1A Trench Road Mallusk Newtownabbey BT36 4TY CO ANTRIM Ireland HYPRED SAS site 11 Medentech Ltd (KERSIA Group) - Clonard Road Y35Y7WY WEXFORD Ireland HYPRED SAS site 12 SOPURA (KERSIA Group) - Parc Paysager de Tyberchamps 14 7180 SENEFFE Belgium HYPRED SAS site 13 SOPURA Quimica (KERSIA Group) - Pol. Ind. ‘La Canaleta’ Avinguda Júpiter no 7 25300 TARREGA (LLEIDA) Spain HYPRED SAS site 14 Holchem Laboratories Ltd (KERSIA Group) - Gateway House, Pilsworth Road, Pilsworth Industrial Estate BL9 8RD Bury United Kingdom of Great Britain and Northern Ireland (the) HYPRED SAS site 15 Bio Armor Développement (KERSIA Group) - Zone industrielle de la Gare 22940 PLAINTEL France

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

Active substance	Octanoic acid
Name of manufacturer	Emery Oleochemicals (M)
Address of manufacturer	Sdn Bhd (63112-D), Lot 4, Jalan Perak, Kawasan Perusahaan 42500 Telok Panglima Garang, Selangor Malaysia
Location of manufacturing sites	Emery Oleochemicals (M) site 1 Sdn Bhd (63112-D), Lot 4, Jalan Perak, Kawasan Perusahaan 42500 Telok Panglima Garang, Selangor Malaysia

2. PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Octanoic acid		Active substance	124-07-2	204-677-5	3 - 10 % (w/w)
Methanesulfonic acid		Non-active substance	75-75-2	200-898-6	0 - 21 % (w/w)
L-(+)-Lactic acid		Non-active substance	79-33-4	201-196-2	0 - 17,6 % (w/w)
N,N-dimethyl-1-Decanamine, N-oxid		Non-active substance	2605-79-0	220-020-5	2,25 - 6 % (w/w)
Ethoxylated alcohol	Ethoxylated alcohol	Non-active substance	31726-34-8	500-077-5	0 -15 % (w/w)

2.2.   Type(s) of formulation

Formulation type(s)	SL Soluble concentrate

PART II

SECOND INFORMATION LEVEL META SPC(S)

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

Identifier	Meta SPC: meta SPC 1

1.2.   Suffix to the authorisation number

Number	1-1

1.3.   Product type(s)

Product type(s)	PT04: Food and feed area

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 (%)
Octanoic acid		Active substance	124-07-2	204-677-5	3 - 3 % (w/w)
Methanesulfonic acid		Non-active substance	75-75-2	200-898-6	21 - 21 % (w/w)
N,N-dimethyl-1-Decanamine, N-oxid		Non-active substance	2605-79-0	220-020-5	2,25 - 2,25 % (w/w)
Ethoxylated alcohol	Ethoxylated alcohol	Non-active substance	31726-34-8	500-077-5	5 - 5 % (w/w)

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

Formulation type(s)	SL Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements	H290: May be corrosive to metals. H314: Causes severe skin burns and eye damage. H335: May cause respiratory irritation. H412: Harmful to aquatic life with long lasting effects.
Precautionary statements	P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER. P501: Dispose of contents local/regional/national/international regulation. P273: Avoid release to the environment.

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Use #1.1 - Circulation in dairy industry

Product type	PT04: Food and feed area
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data
Field(s) of use	indoor use Cleaning - disinfection of circuits in dairy industry
Application method(s)	Method: Closed system : Circulation Detailed description: CIP, circulation
Application rate(s) and frequency	Application Rate: - Use 1 % product solution for bactericidal activity and 1,5 % product solution for yeasticidal activity Number and timing of application: 1 to 3 cycles per day, and 208 to 360 days per year
Category(ies) of users	professional
Pack sizes and packaging material	Opaque jerrycan HDPE 5L Opaque jerrycan HDPE 10L Opaque jerrycan HDPE 22L Opaque drum HDPE 60L Opaque drum HDPE 120L Opaque drum 220L Opaque container HDPE 640L Opaque container HDPE 1000L

4.1.1.   Use-specific instructions for use

Rinse the circuits with drinking water before disinfection.

Apply the product by circulation.

Product concentration and contact time:

• — 1 % bactericidal in 5 minutes

• — 1,5 % yeasticidal in 15 minutes

Temperature: 40 - 85 °C

Final rinse with drinking water.

4.1.2.   Use-specific risk mitigation measures

See general directions for use

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

See general directions for use

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

See general directions for use

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

See general directions for use

4.2.   Use description

Table 2

Use# 1.2 - Circulation in farms

Product type	PT04: Food and feed area
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data
Field(s) of use	indoor use Cleaning - disinfection of milking equipment and milking robots in farms
Application method(s)	Method: Closed system : Circulation Detailed description: Circulation
Application rate(s) and frequency	Application Rate: - Use 0,8 % product solution for bactericidal activity and 1,5 % product solution for yeasticidal activity. Number and timing of application: The milk installationis cleaned and disinfected twice a day and the milk tank is cleaned and disinfected once every three days.
Category(ies) of users	professional
Pack sizes and packaging material	Opaque jerrycan HDPE 5L Opaque jerrycan HDPE 10L Opaque jerrycan HDPE 22L Opaque drum HDPE 60L Opaque drum HDPE 120L Opaque drum 220L Opaque container HDPE 640L Opaque container HDPE 1000L

4.2.1.   Use-specific instructions for use

Machines with or without a programmer.

• 1) After milking, rinse the equipment with warm drinking water.

• 2) Apply the solution by circulation at an initial recommended temperature of 60 °C minimum to achieve a final temperature of 40-45 °C. Product concentration and contact time : 0,8 % bactericidal in 10 minutes 1,5 % yeasticidal in 15 minutes Do not use at temperature above 75 °C.

• 3) Rinse with cold drinking water.

Use the product twice a day or once a day when alternating with another product.

When alternating, use a cleaner-disinfectant or a cleaning product 1 to 4 times per week depending on the temperature reached in the system.

Contact your supplier for choosing the alternative product and the frequency of use.

Do not mix [name of the authorised product] with an alkaline or chlorinated alkaline product.

4.2.2.   Use-specific risk mitigation measures

See general directions for use

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

See general directions for use

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

See general directions for use

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

See general directions for use

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use

See use specific instructions for use.

5.2.   Risk mitigation measures

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

• — Ensure adequate ventilation during the application.

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

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

FIRST AID

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

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

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

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

Refer to the Safety Data Sheets available for professional user. It contains an emergency phone number

When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.

NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

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

Do not discharge the product directly to sewer or to the environment.

Dispose the product and its packaging in accordance with applicable local and national regulations.

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

Shelf life: 2 years in HDPE

Conditions of storage: keep only in the original packaging. Keep container closed. Do not store at temperature above 40 °C.

6. OTHER INFORMATION

A cleaning claim has not been assessed as it is out of the scope of the BPR.

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)	Trade name(s)	Trade name(s)	HYPRACID ONE	HYPRACID ONE	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	DEPTACID BD	DEPTACID BD	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	prevides®MS	prevides®MS	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	DEPTACID OCTACIP	DEPTACID OCTACIP	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	OCTACID ONE	OCTACID ONE	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	OCTA-ONE	OCTA-ONE	Market area: EU	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number			EU-0021020-0001 1-1	EU-0021020-0001 1-1	EU-0021020-0001 1-1
Common name	IUPAC name	Function	Function	CAS number	CAS number	EC number	Content (%)
Octanoic acid		Active substance	Active substance	124-07-2	124-07-2	204-677-5	3 % (w/w)
Methanesulfonic acid		Non-active substance	Non-active substance	75-75-2	75-75-2	200-898-6	21 % (w/w)
N,N-dimethyl-1-Decanamine, N-oxid		Non-active substance	Non-active substance	2605-79-0	2605-79-0	220-020-5	2,25 % (w/w)
Ethoxylated alcohol	Ethoxylated alcohol	Non-active substance	Non-active substance	31726-34-8	31726-34-8	500-077-5	5 % (w/w)

1. META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier	Meta SPC: meta SPC 2

1.2.   Suffix to the authorisation number

Number	1-2

1.3.   Product type(s)

Product type(s)	PT04: Food and feed area

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 (%)
Octanoic acid		Active substance	124-07-2	204-677-5	10 - 10 % (w/w)
Methanesulfonic acid		Non-active substance	75-75-2	200-898-6	14 - 14 % (w/w)
N,N-dimethyl-1-Decanamine, N-oxid		Non-active substance	2605-79-0	220-020-5	4,5 - 4,5 % (w/w)
Ethoxylated alcohol	Ethoxylated alcohol	Non-active substance	31726-34-8	500-077-5	15 - 15 % (w/w)

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

Formulation type(s)	SL Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements	H290: May be corrosive to metals. H302: Harmful if swallowed. H314: Causes severe skin burns and eye damage. H412: Harmful to aquatic life with long lasting effects.
Precautionary statements	P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER. P501: Dispose of contents local/regional/national/international regulation. P273: Avoid release to the environment.

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Use#2.1 - Circulation

Product type	PT04: Food and feed area
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data
Field(s) of use	indoor use Disinfection of circuits in breweries, dairy and beverage industries
Application method(s)	Method: Closed system : Circulation Detailed description: CIP, circulation
Application rate(s) and frequency	Application Rate: - Use 0,4 % product solution for bactericidal activity and 0,6 % product solution for yeasticidal activity. Number and timing of application: 1 to 3 cycles per day, and 208 to 360 days per year
Category(ies) of users	professional
Pack sizes and packaging material	Opaque jerrycan HDPE 5L Opaque jerrycan HDPE 10L Opaque jerrycan HDPE 22L Opaque drum HDPE 60L Opaque drum HDPE 120L Opaque drum 220L Opaque container HDPE 640L Opaque container HDPE 1000L

4.1.1.   Use-specific instructions for use

See general directions for use

4.1.2.   Use-specific risk mitigation measures

See general directions for use

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

See general directions for use

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

See general directions for use

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

See general directions for use

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1.   Instructions for use

Prior to the application of the product, clean with a detergent and rinse with drinking water.

Apply the product by circulation.

Product concentration and contact time:

• — 0,4 % bactericidal in 5 minutes

• — 0,6 % yeasticidal in 15 minutes

Temperature: 20 - 85 °C

Final rinse with drinking water.

5.2.   Risk mitigation measures

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

• — Ensure adequate ventilation during the application.

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

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

FIRST AID

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

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

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

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

Refer to the Safety Data Sheets available for professional user. It contains an emergency phone number.

When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.

NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

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

Do not discharge the product directly to sewer or to the environment.

Dispose the product and its packaging in accordance with applicable local and national regulations.

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

Shelf life: 2 years in HDPE

Conditions of storage: keep only in the original packaging. Keep container closed. Keep in a cool place. Do not store at temperature above 40 °C.

6. OTHER INFORMATION

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

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

Trade name(s)	Trade name(s)	Trade name(s)	DEPTACID CCB	DEPTACID CCB	Market area: EU	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number			EU-0021020-0002 1-2	EU-0021020-0002 1-2	EU-0021020-0002 1-2
Common name	IUPAC name	Function	Function	CAS number	CAS number	EC number	Content (%)
Octanoic acid		Active substance	Active substance	124-07-2	124-07-2	204-677-5	10 % (w/w)
Methanesulfonic acid		Non-active substance	Non-active substance	75-75-2	75-75-2	200-898-6	14 % (w/w)
N,N-dimethyl-1-Decanamine, N-oxid		Non-active substance	Non-active substance	2605-79-0	2605-79-0	220-020-5	4,5 % (w/w)
Ethoxylated alcohol	Ethoxylated alcohol	Non-active substance	Non-active substance	31726-34-8	31726-34-8	500-077-5	15 % (w/w)

1. META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

Identifier	Meta SPC: meta SPC 3

1.2.   Suffix to the authorisation number

Number	1-3

1.3.   Product type(s)

Product type(s)	PT04: Food and feed area

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 (%)
Octanoic acid		Active substance	124-07-2	204-677-5	10 - 10 % (w/w)
L-(+)-Lactic acid		Non-active substance	79-33-4	201-196-2	17,6 - 17,6 % (w/w)
N,N-dimethyl-1-Decanamine, N-oxid		Non-active substance	2605-79-0	220-020-5	6 - 6 % (w/w)

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

Formulation type(s)	SL Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

Hazard statements	H290: May be corrosive to metals. H314: Causes severe skin burns and eye damage. H412: Harmful to aquatic life with long lasting effects.
Precautionary statements	P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER. P501: Dispose of contents local/regional/national/international regulation. P273: Avoid release to the environment.

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Use#3.1 - Circulation

Product type	PT04: Food and feed area
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data
Field(s) of use	indoor use Disinfection of circuits in breweries, dairy and beverage industries
Application method(s)	Method: Closed system : Circulation Detailed description: CIP, circulation
Application rate(s) and frequency	Application Rate: - Use 0,4 % product solution Number and timing of application: 1 to 3 cycles per day, and 208 to 360 days per year
Category(ies) of users	professional
Pack sizes and packaging material	Opaque jerrycan HDPE 5L Opaque jerrycan HDPE 10L Opaque jerrycan HDPE 22L Opaque drum HDPE 60L Opaque drum HDPE 120L Opaque drum 220L Opaque container HDPE 640L Opaque container HDPE 1000L

4.1.1.   Use-specific instructions for use

See general directions for use

4.1.2.   Use-specific risk mitigation measures

See general directions for use

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

See general directions for use

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

See general directions for use

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

See general directions for use

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3

5.1.   Instructions for use

Prior to the application of the product, clean with a detergent and rinse with drinking water.

Apply the product by circulation.

Product concentration: 0,4 %

Contact time:

• — 5 minutes for bactericidal activity

• — 15 minutes for yeasticidal activity

Temperature: 20 - 85 °C

Final rinse with drinking water.

5.2.   Risk mitigation measures

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

• — Ensure adequate ventilation during the application.

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

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

FIRST AID

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

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

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

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

Refer to the Safety Data Sheets available for professional user. It contains an emergency phone number.

When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.

NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

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

Do not discharge the product directly to sewer or to the environment.

Dispose the product and its packaging in accordance with applicable local and national regulations.

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

Shelf life: 2 years in HDPE

Conditions of storage: keep only in the original packaging. Keep container closed. Do not store at temperature above 40 °C.

6. OTHER INFORMATION

7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

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

Trade name(s)	Trade name(s)	Trade name(s)	DEPTACID CB	DEPTACID CB	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	DEPTIL CB	DEPTIL CB	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	SOPURSAN CB	SOPURSAN CB	Market area: EU	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number			EU-0021020-0003 1-3	EU-0021020-0003 1-3	EU-0021020-0003 1-3
Common name	IUPAC name	Function	Function	CAS number	CAS number	EC number	Content (%)
Octanoic acid		Active substance	Active substance	124-07-2	124-07-2	204-677-5	10 % (w/w)
L-(+)-Lactic acid		Non-active substance	Non-active substance	79-33-4	79-33-4	201-196-2	17,6 % (w/w)
N,N-dimethyl-1-Decanamine, N-oxid		Non-active substance	Non-active substance	2605-79-0	2605-79-0	220-020-5	6 % (w/w)

1. META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 4 identifier

Identifier	Meta SPC: meta SPC 4

1.2.   Suffix to the authorisation number

Number	1-4

1.3.   Product type(s)

Product type(s)	PT04: Food and feed area

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 (%)
Octanoic acid		Active substance	124-07-2	204-677-5	3 - 3 % (w/w)
Methanesulfonic acid		Non-active substance	75-75-2	200-898-6	21 - 21 % (w/w)
N,N-dimethyl-1-Decanamine, N-oxid		Non-active substance	2605-79-0	220-020-5	3 - 3 % (w/w)
Ethoxylated alcohol	Ethoxylated alcohol	Non-active substance	31726-34-8	500-077-5	5 - 5 % (w/w)

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

Formulation type(s)	SL Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

Hazard statements	H290: May be corrosive to metals. H314: Causes severe skin burns and eye damage. H335: May cause respiratory irritation. H412: Harmful to aquatic life with long lasting effects.
Precautionary statements	P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER. P501: Dispose of contents local/regional/national/international regulation. P273: Avoid release to the environment.

4. AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Use # 4.1 – Separative membranes circulation

Product type	PT04: Food and feed area
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data
Field(s) of use	indoor use Disinfectant or cleaner-disinfectant for membranes used in reverse osmosis and nanofiltration in dairy and beverage industries.
Application method(s)	Method: Closed system : Circulation Detailed description: Circulation
Application rate(s) and frequency	Application Rate: - Use 0,75 % product solution if cleaning is applied prior to the disinfection Use 1 % product solution if no cleaning is applied prior to the disinfection Number and timing of application: 1 to 3 cycles per day, and 104 to 312 days per year
Category(ies) of users	professional
Pack sizes and packaging material	Opaque jerrycan HDPE 5L Opaque jerrycan HDPE 10L Opaque jerrycan HDPE 22L Opaque drum HDPE 60L Opaque drum HDPE 120L Opaque drum 220L Opaque container HDPE 640L Opaque container HDPE 1000L

4.1.1.   Use-specific instructions for use

See general directions for use

4.1.2.   Use-specific risk mitigation measures

See general directions for use

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

See general directions for use

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

See general directions for use

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

See general directions for use

5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4

5.1.   Instructions for use

Rinse the membranes with drinking water or clean and rinse with drinking water before disinfection.

Apply the product by circulation

Product concentration after water rinse: 1 %

Product concentration with previous cleaning: 0,75 %

Contact time:

• — 5 minutes for bactericidal activity

• — 15 minutes for yeasticidal activity

Temperature: 40 – 85 °C

Final rinse with drinking water.

5.2.   Risk mitigation measures

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

• — Ensure adequate ventilation during the application.

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

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

FIRST AID

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

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

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

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

Refer to the Safety Data Sheets available for professional user. It contains an emergency phone number

When asking for medical advice keep packaging or label at hand and call a POISON CENTER or doctor/physician.

NEVER administer liquids/solids orally to an impaired or unconscious individual; place individual in left sideways position with the head lowered and the knees bent.

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

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

Do not discharge the product directly to sewer or to the environment.

Dispose the product and its packaging in accordance with applicable local and national regulations.

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

Shelf life: 2 years in HDPE

Conditions of storage: keep only in the original packaging. Keep container closed. Do not store at temperature above 40 °C.

6. OTHER INFORMATION

A cleaning claim has not been assessed as it is out of the scope of the BPR.

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)	Trade name(s)	Trade name(s)	DEPTACID WCM	DEPTACID WCM	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	SOPURCLEAN NF WCM	SOPURCLEAN NF WCM	Market area: EU	Market area: EU	Market area: EU
Trade name(s)	Trade name(s)	Trade name(s)	Osmotask AS	Osmotask AS	Market area: EU	Market area: EU	Market area: EU
Authorisation number	Authorisation number	Authorisation number			EU-0021020-0004 1-4	EU-0021020-0004 1-4	EU-0021020-0004 1-4
Common name	IUPAC name	Function	Function	CAS number	CAS number	EC number	Content (%)
Octanoic acid		Active substance	Active substance	124-07-2	124-07-2	204-677-5	3 % (w/w)
Methanesulfonic acid		Non-active substance	Non-active substance	75-75-2	75-75-2	200-898-6	21 % (w/w)
N,N-dimethyl-1-Decanamine, N-oxid		Non-active substance	Non-active substance	2605-79-0	2605-79-0	220-020-5	3 % (w/w)
Ethoxylated alcohol	Ethoxylated alcohol	Non-active substance	Non-active substance	31726-34-8	31726-34-8	500-077-5	5 % (w/w)