Commission Implementing Regulation (EU) 2020/580

Contents

THE EUROPEAN COMMISSION, Having regard to the Treaty on th…
1 A Union authorisation with authorisation number EU-0021157…
2 This Regulation shall enter into force on the twentieth da…
Summary of product characteristics for a biocidal product family
- Part I — first information level
- Part II — second information level – meta spc(s)

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^note, and in particular the first subparagraph of Article 44(5) thereof,Whereas:

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

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

(3)On 15 December 2017, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

(4)On 15 July 2019, the Agency submitted to the Commission an opinion^note, including the draft summary of the biocidal product characteristics (‘SPC’) of ‘SOPURCLEAN’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

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

(6)On 26 July 2019, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(7)The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘SOPURCLEAN’.

(8)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1 #

A Union authorisation with authorisation number EU-0021157-0000 is granted to SOPURA N.V. for the making available on the market and use of the biocidal product family ‘SOPURCLEAN’ in accordance with the summary of the biocidal product characteristics set out in the Annex.The Union authorisation is valid from 18 May 2020 until 30 April 2030.

Article 2 #

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

Summary of product characteristics for a biocidal product family

SOPURCLEAN

Product type 4 – Food and feed area (Disinfectants)

Authorisation number: EU-0021157-0000

R4BP asset number: EU-0021157-0000

Part I — first information level

1. Administrative information

1.1. Family name

Name	SOPURCLEAN

1.2. Product type(s)

Product type(s)

PT04 – Food and feed area (Disinfectants)

1.3. Authorisation holder

Name and address of the authorisation holder	Name	SOPURA N.V.
Address	Rue de Trazegnies 199, 6180 COURCELLES, Belgium
Authorisation number	EU-0021157-0000
R4BP asset number	EU-0021157-0000
Date of the authorisation	18 May 2020
Expiry date of the authorisation	30 April 2030

1.4. Manufacturer(s) of the biocidal products

Name of manufacturer	SOPURA N.V.
Address of manufacturer	Rue de Trazegnies 199, 6180 COURCELLES Belgium
Location of manufacturing sites	PIB de Tyberchamps 14, 7180 SENEFFE BelgiumRue de Trazegnies 199, 6180 COURCELLES Belgium

Name of manufacturer	SOPURA QUIMICA
Address of manufacturer	Poligon ‘La Canaleta’, Avinguda Júpiter 9, 25300 TARREGA Spain
Location of manufacturing sites	Poligon ‘La Canaleta’, Avinguda Júpiter 9, 25300 TARREGA Spain

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

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

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

2. Product family composition and formulation

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Min	Max
Octanoic acid		Active Substance	124-07-2	204-677-5	1,1	2,7
Decanoic acid		Active Substance	334-48-5	206-376-4	0,3	1,5
Sulfuric acid		Non-active substance	7664-93-9	231-639-5	0,0	31,2
Propionic acid		Non-active substance	79-09-4	201-176-3	0,0	19,5
Phosphoric acid		Non-active substance	7664-38-2	231-633-2	0,0	30,0
Nitric acid		Non-active substance	7697-37-2	231-714-2	0,0	18,0
Methane sulfonic acid		Non-active substance	75-75-2	200-898-6	0,0	20,3
Glycolic acid		Non-active substance	79-14-1	201-180-5	0,0	4,2
Lactic acid		Non-active substance	79-33-4	201-196-2	0,0	35,2
Citric acid		Non-active substance	77-92-9	201-069-1	0,0	3,0

2.2. Type(s) of formulation

Formulation(s)

SL – Soluble concentrate

Part II — second information level – meta spc(s)

Meta spc 1

1. Meta spc 1 administrative information

1.1. Meta SPC 1 identifier

Identifier

Meta SPC 1

1.2. Suffix to the authorisation number

Number

1-1

1.3. Product type(s)

Product type(s)

PT04 – Food and feed area (Disinfectants)

2. Meta spc 1 composition

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Min	Max
Octanoic acid		Active Substance	124-07-2	204-677-5	1,1	1,8
Decanoic acid		Active Substance	334-48-5	206-376-4	0,75	1,5
Sulfuric acid		Non-active substance	7664-93-9	231-639-5	0,0	31,2
Propionic acid		Non-active substance	79-09-4	201-176-3	0,0	0,0
Phosphoric acid		Non-active substance	7664-38-2	231-633-2	0,0	30,0
Nitric acid		Non-active substance	7697-37-2	231-714-2	0,0	0,0
Methane sulfonic acid		Non-active substance	75-75-2	200-898-6	0,0	12,6
Glycolic acid		Non-active substance	79-14-1	201-180-5	0,0	4,2
Lactic acid		Non-active substance	79-33-4	201-196-2	0,0	0,0
Citric acid		Non-active substance	77-92-9	201-069-1	0,0	3,0

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

Formulation(s)

SL – Soluble concentrate

3. Hazard and precautionary statements of the meta spc 1

Hazard statements

May be corrosive to metals.Causes severe skin burns and eye damage.

Precautionary statements

Do not breathe vapours.IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.Immediately call a POISON CENTER.Immediately call a doctor.Wear eye protection.Wear face protection.Wear protective clothing.Wear protective gloves.IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water (or shower).Keep only in original container.Store in a well-ventilated place.Keep container tightly closed.Absorb spillage to prevent material damage.Dispose of contents in accordance with local/regional/national/international regulations.

4. Authorised use(s) of the meta spc 1

4.1. Use description

Table 1
Product type	PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	BacteriaYeasts
Field(s) of use	IndoorIn food and feed areas
Application method(s)	Closed systemFor disinfection of pipes, tanks, and other parts of the closed system:Biocidal product (semi-)automatically dosed in the CIP vessel (either by volume or conductivity measurements)Circulation in a closed CIP system
Application rate(s) and frequency	For an effect on bacteria and yeasts: Dilution rate: 1,5 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 2 % v/v. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.-
Category(ies) of users	IndustrialTrained professional
Pack sizes and packaging material	Jerrycan High-density polyethylene (PE-HD), containing: 10 to 12,5 kg.Jerrycan (PE-HD), containing: 20 to 25 kg.Drums (PE-HD) containing 200 to 250 kg.Containers (PE-HD) containing 600 to 750 kg.Intermediate bulk containers (IBC, PE-HD) containing 1100 to 1250 kgBulk delivery.

4.1.1. Use-specific instructions for use

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

4.1.2. Use-specific risk mitigation measures

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

—Treated equipment (vessels) and dosing equipment has to be rinsed with drinking water after use.

During the mixing, loading and application phases:

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
Product type	PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	BacteriaYeasts
Field(s) of use	IndoorIn food and feed areas
Application method(s)	Open system: immersionFor disinfection of small hard non-porous parts (e.g. spare parts, tools, valves, hoses) used in the food manufacturing process:Concentrated product pumped in the bath and tap water added to reach the required concentrationImmersion
Application rate(s) and frequency	For an effect on bacteria and on yeasts: Dilution rate: 1,5 %v/v In case of outbreaks of Pediococcus damnosus, the products must be used at 2 % v/v. Contact time: minimum 15 minutes at +4 °C and above, up to 20– 25 °C.-
Category(ies) of users	IndustrialTrained professional
Pack sizes and packaging material	Jerrycan (PE-HD), containing: 10 to 12,5 kg.Jerrycan (PE-HD), containing: 20 to 25 kg.Drums (PE-HD) containing 200 to 250 kg.Containers (PE-HD) containing 600 to 750 kg.IBC (PE-HD) containing 1100 to 1250 kgBulk delivery.

4.2.1. Use-specific instructions for use

The dipping solution must be replaced by a fresh solution when it becomes visually polluted, and in all cases daily.

4.2.2. Use-specific risk mitigation measures

During the post application phase:

Rinse the equipment with drinking water.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5. GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1. OF THE META SPC 1

5.1. Instructions for use

For an effect on bacteria and on yeasts

Rinsing and cleaning before disinfection:

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

Disinfecting cycle:

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

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

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

Final rinsing with drinking water

5.2. Risk mitigation measures

Use in well-ventilated places.

During the mixing, loading and application phases: wear a protective coverall. Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information). Use eye protection during handling of the product. Wear face protection.

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

Particulars of likely direct or indirect adverse effects:

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

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

First aid instructions:

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

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

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

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

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

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

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

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

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

Advice for medical and healthcare personnel:

In case of ingestion consider performing an endoscopic procedure.

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

Symptomatic and supportive treatment.

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

Emergency measures to protect the environment:

Prevent entry into sewers and public waters.

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

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

Keep only in the original packaging tightly closed in a cool and well-ventilated place

Keep the product away from direct sunlight, source of heat and ignition.

The product must be stored at temperatures below +30 °C.

Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) nor down the drains.

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

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

Storage conditions:

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

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

Handle in accordance with good industrial hygiene and safety procedures.

Packaging material: Use approved materials suitable for corrosive liquids.

Shelf-life: 12 months in the original packaging.

6. Other information

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

7. Third information level: individual products in the meta spc 1

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

Trade name(s)	SEPTACID BN
Authorisation number	EU-0021157-0001 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Octanoic acid		Active Substance	124-07-2	204-677-5	1,5
Decanoic acid		Active Substance	334-48-5	206-376-4	1,5
Sulfuric acid		Non-active substance	7664-93-9	231-639-5	31,2
Glycolic acid		Non-active substance	79-14-1	201-180-5	4,2

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

Trade name(s)	SEPTACID BN PS
Authorisation number	EU-0021157-0002 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Octanoic acid		Active Substance	124-07-2	204-677-5	1,5
Decanoic acid		Active Substance	334-48-5	206-376-4	1,5
Phosphoric acid		Non-active substance	7664-38-2	231-633-2	30,0
Glycolic acid		Non-active substance	79-14-1	201-180-5	4,2

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

Trade name(s)	SOPURCIP EC
Authorisation number	EU-0021157-0003 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Octanoic acid		Active Substance	124-07-2	204-677-5	1,1
Decanoic acid		Active Substance	334-48-5	206-376-4	0,75
Sulfuric acid		Non-active substance	7664-93-9	231-639-5	7,8
Methane sulfonic acid		Non-active substance	75-75-2	200-898-6	12,6

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

Trade name(s)	SOPURCLEAN BN
Authorisation number	EU-0021157-0004 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Octanoic acid		Active Substance	124-07-2	204-677-5	1,8
Decanoic acid		Active Substance	334-48-5	206-376-4	1,2
Sulfuric acid		Non-active substance	7664-93-9	231-639-5	29,64
Citric acid		Non-active substance	77-92-9	201-069-1	3,0

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

Trade name(s)	SOPURCLEAN BN PS
Authorisation number	EU-0021157-0005 1-1
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Octanoic acid		Active Substance	124-07-2	204-677-5	1,8
Decanoic acid		Active Substance	334-48-5	206-376-4	1,2
Phosphoric acid		Non-active substance	7664-38-2	231-633-2	30,0
Citric acid		Non-active substance	77-92-9	201-069-1	2,5

Meta spc 2

1. Meta spc 2 administrative information

1.1. Meta SPC 2 identifier

Identifier

Meta SPC 2

1.2. Suffix to the authorisation number

Number

1-2

1.3. Product type(s)

Product type(s)

PT04 – Food and feed area (Disinfectants)

2. Meta spc 2 composition

2.1. Qualitative and quantitative information on the composition of the meta SPC 2

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Min	Max
Octanoic acid		Active Substance	124-07-2	204-677-5	2,7	2,7
Decanoic acid		Active Substance	334-48-5	206-376-4	0,3	0,3
Sulfuric acid		Non-active substance	7664-93-9	231-639-5	0,0	0,0
Propionic acid		Non-active substance	79-09-4	201-176-3	19,5	19,5
Phosphoric acid		Non-active substance	7664-38-2	231-633-2	3,8	3,8
Nitric acid		Non-active substance	7697-37-2	231-714-2	0,0	0,0
Methane sulfonic acid		Non-active substance	75-75-2	200-898-6	0,0	0,0
Glycolic acid		Non-active substance	79-14-1	201-180-5	0,0	0,0
Lactic acid		Non-active substance	79-33-4	201-196-2	35,2	35,2
Citric acid		Non-active substance	77-92-9	201-069-1	0,0	0,0

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

Formulation(s)

SL – Soluble concentrate

3. Hazard and precautionary statements of the meta spc 2

Hazard statements

May be corrosive to metals.Causes severe skin burns and eye damage.May cause respiratory irritation.

Precautionary statements

Do not breathe vapours.Wear protective gloves.Wear protective clothing.Wear eye protection.Wear face protection.IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water (or shower).IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.Immediately call a POISON CENTER.Immediately call a doctor.Keep only in original container.Store in a well-ventilated place.Keep container tightly closed.IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.Dispose of contents in accordance with local/regional/national/international regulations.

4. Authorised use(s) of the meta spc 2

4.1. Use description

Table 3
Product type	PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	BacteriaYeasts
Field(s) of use	IndoorIn food and feed areas
Application method(s)	Closed systemFor disinfection of pipes, tanks, and other parts of the closed system:Biocidal product (semi-)automatically dosed in the CIP vessel (either by volume or conductivity measurements)Circulation in a closed CIP system
Application rate(s) and frequency	- - For an effect on bacteria and on yeasts: Dilution rate: 1 %v/v In case of outbreaks of Pediococcus damnosus, the product must be used at 1,5 % v/v. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.-
Category(ies) of users	IndustrialTrained professional
Pack sizes and packaging material	Jerrycan (PE-HD), containing: 10 to 12,5 kg.Jerrycan (PE-HD), containing: 20 to 25 kg.Drums (PE-HD) containing 200 to 250 kg.Containers (PE-HD) containing 600 to 750 kgIBC (PE-HD) containing 1100 to 1250 kgBulk delivery.

4.1.1. Use-specific instructions for use

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

4.1.2. Use-specific risk mitigation measures

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

During the mixing, loading and application phases:

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.2. Use description

Table 4
Product type	PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	BacteriaYeasts
Field(s) of use	IndoorIn food and feed areas
Application method(s)	SprayingFor disinfection of hard non-porous surfaces in contact with food processing:Diluted biocidal product sprayed via a low pressure spraying device
Application rate(s) and frequency	Maximum application rate: 100 mL/m² – For an effect on bacteria and on yeasts: Dilution rate: 1 %v/v. In case of outbreaks of Pediococcus damnosus, the product must be used at 1,5 %. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.-
Category(ies) of users	IndustrialTrained professional
Pack sizes and packaging material	Jerrycan (PE-HD), containing: 10 to 12,5 kg^note.Jerrycan (PE-HD), containing: 20 to 25 kg.Drums (PE-HD) containing 200 to 250 kg.Containers (PE-HD) containing 600 to 750 kg.IBC (PE-HD) containing 1100 to 1250 kgBulk delivery.

4.2.1. Use-specific instructions for use

See general directions for use.

4.2.2. Use-specific risk mitigation measures

Fully automated process where workers are not present during spraying.

Workers only re-enter in the work area when spraying solution has been drained.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.3. Use description

Table 5
Product type	PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	BacteriaYeast
Field(s) of use	IndoorIn food and feed areas
Application method(s)	Manual applicationFor disinfection of hard non-porous small parts and surfaces used in the food manufacturing process:Diluted product sprayed via a low pressure spraying deviceAfter the optimal contact time for disinfection, the small parts are to be wiped or mopped or brushed.
Application rate(s) and frequency	Maximum application rate: 100 mL/m² – For an effect on bacteria and on yeasts: Dilution rate: 1 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 1,5 %. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.-
Category(ies) of users	IndustrialTrained professional
Pack sizes and packaging material	Jerrycan (PE-HD), containing: 10 to 12,5 kg^note.Jerrycan (PE-HD), containing: 20 to 25 kg.Drums (PE-HD) containing 200 to 250 kg.Containers (PE-HD) containing 600 to 750 kg.IBC (PE-HD) containing 1100 to 1250 kgBulk delivery.

4.3.1. Use-specific instructions for use

See general directions for use.

4.3.2. Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.4. Use description

Table 6
Product type	PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	BacteriaYeasts
Field(s) of use	IndoorIn food and feed areas
Application method(s)	Open system: immersionFor disinfection of hard non-porous small parts (e.g. spare parts, tools, valves, hoses) used in the food manufacturing process:Concentrated product pumped in the bath and tap water added to reach the required concentrationImmersion
Application rate(s) and frequency	For an effect on bacteria and on yeasts: Dilution rate: 1 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 1,5 %. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.-
Category(ies) of users	IndustrialTrained professional
Pack sizes and packaging material	Jerrycan (PE-HD), containing: 10 to 12,5 kg^note.Jerrycan (PE-HD), containing: 20 to 25 kg^note.Drums (PE-HD) containing 200 to 250 kg^note.Containers (PE-HD) containing 600 to 750 kg^note.IBC (Internal bulk containers, PE-HD) containing 1100 to 1250 kg^noteBulk delivery.

4.4.1. Use-specific instructions for use

The dipping solution must be replaced by a fresh solution when it becomes visually polluted, and in all cases daily.

4.4.2. Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

5. GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2. OF THE META SPC 2

5.1. Instructions for use

For an effect on bacteria and on yeasts

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

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

Disinfecting cycle:

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

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

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

Final rinsing: not necessary

5.2. Risk mitigation measures

During the mixing and loading and application phases: wear a protective coverall. Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information). Use of eye protection during handling of the product. Wear face protection.

Use in well ventilated places.

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

Particulars of likely direct or indirect adverse effects:

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

First aid instructions:

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

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

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

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

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

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

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

Advice for medical and healthcare personnel:

In case of ingestion consider performing an endoscopic procedure.

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

Symptomatic and supportive treatment.

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

Emergency measures to protect the environment:

Prevent entry into sewers and public waters.

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

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

Keep only in the original packaging tightly closed in a cool and well-ventilated place

Keep the product away from direct sunlight, source of heat and ignition.

The product must be stored at temperatures below +30 °C.

Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) nor down the drains

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

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

Storage conditions:

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

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

Handle in accordance with good industrial hygiene and safety procedures.

Packaging material: Use approved materials suitable for corrosive liquids.

Shelf-life: 12 months in the original packaging.

6. Other information

7. Third information level: individual products in the meta spc 2

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

Trade name(s)	SOPURCLEAN NR
Authorisation number	EU-0021157-0006 1-2
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Octanoic acid		Active Substance	124-07-2	204-677-5	2,7
Decanoic acid		Active Substance	334-48-5	206-376-4	0,3
Propionic acid		Non-active substance	79-09-4	201-176-3	19,5
Phosphoric acid		Non-active substance	7664-38-2	231-633-2	3,8
Lactic acid		Non-active substance	79-33-4	201-196-2	35,2

Meta spc 3

1. Meta spc 3 administrative information

1.1. Meta SPC 3 identifier

Identifier

Meta SPC 3

1.2. Suffix to the authorisation number

Number

1-3

1.3. Product type(s)

Product type(s)

PT04 – Food and feed area (Disinfectants)

2. Meta spc 3 composition

2.1. Qualitative and quantitative information on the composition of the meta SPC 3

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Min	Max
Octanoic acid		Active Substance	124-07-2	204-677-5	1,8	1,8
Decanoic acid		Active Substance	334-48-5	206-376-4	1,2	1,2
Sulfuric acid		Non-active substance	7664-93-9	231-639-5	0,0	0,0
Propionic acid		Non-active substance	79-09-4	201-176-3	0,0	0,0
Phosphoric acid		Non-active substance	7664-38-2	231-633-2	0,0	0,0
Nitric acid		Non-active substance	7697-37-2	231-714-2	18,0	18,0
Methane sulfonic acid		Non-active substance	75-75-2	200-898-6	0,0	0,0
Glycolic acid		Non-active substance	79-14-1	201-180-5	0,0	0,0
Lactic acid		Non-active substance	79-33-4	201-196-2	0,0	0,0
Citric acid		Non-active substance	77-92-9	201-069-1	0,0	0,0

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

Formulation(s)

SL – Soluble concentrate

3. Hazard and precautionary statements of the meta spc 3

Hazard statements

May be corrosive to metals.Causes severe skin burns and eye damage.Harmful if inhaled.

Precautionary statements

Do not breathe vapours.Wear protective clothing.Wear eye protection.Wear protective gloves.Wear face protection.IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.Immediately call a doctor.Immediately call a POISON CENTER.Keep only in original container.IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.Store in a well-ventilated place.Keep container tightly closed.Absorb spillage to prevent material damage.Dispose of contents in accordance with local/regional/national/international regulations.

4. Authorised use(s) of the meta spc 3

4.1. Use description

Table 7
Product type	PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	BacteriaYeasts
Field(s) of use	IndoorIn food and feed areas
Application method(s)	Closed systemFor disinfection of pipes, tanks, and other parts of the closed system.Biocidal product (semi-)automatically dosed in the CIP vessel (either by volume or conductivity measurements)Circulation in a closed CIP system
Application rate(s) and frequency	For an effect on bacteria and on yeasts: Dilution rate: 1,5 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 2 % v/v. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.-
Category(ies) of users	IndustrialTrained professional
Pack sizes and packaging material	Jerrycan (PE-HD), containing: 10 to 12,5 kg.Jerrycan (PE-HD), containing: 20 to 25 kg.Drums (PE-HD) containing 200 to 250 kg.Containers (PE-HD) containing 600 to 750 kg.IBC (PE-HD) containing 1100 to 1250 kgBulk delivery.

4.1.1. Use-specific instructions for use

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

4.1.2. Use-specific risk mitigation measures

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

—Wear respiratory mask.

During the mixing, loading and application phases:

During the mixing and loading phases:

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 USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3. OF THE META SPC 3

5.1. Instructions for use

For an effect on bacteria and on yeasts

Rinsing and cleaning before disinfection:

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

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

Disinfecting cycle:

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

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

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

Final rinsing with drinking water

5.2. Risk mitigation measures

Use in well-ventilated places.

During the mixing, loading and application phases:

Wear a protective coverall. Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information). Use of eye protection during handling of the product. Wear face protection.

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

Particulars of likely direct or indirect adverse effects:

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

First aid instructions:

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

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

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

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

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

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

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

Advice for medical and healthcare personnel:

In case of ingestion consider performing an endoscopic procedure.

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

Symptomatic and supportive treatment.

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

Emergency measures to protect the environment:

Prevent entry into sewers and public waters.

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

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

Keep only in the original packaging tightly closed in a cool and well-ventilated place

Keep the product away from direct sunlight, source of heat and ignition.

The product must be stored at temperatures below +30 °C.

Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

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

Storage conditions:

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

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

Handle in accordance with good industrial hygiene and safety procedures.

Packaging material: Use approved materials suitable for corrosive liquids.

Shelf-life: 12 months in the original packaging.

6. Other information

7. Third information level: individual products in the meta spc 3

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

Trade name(s)	SOPURCLEAN OP-N
Authorisation number	EU-0021157-0007 1-3
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Octanoic acid		Active Substance	124-07-2	204-677-5	1,8
Decanoic acid		Active Substance	334-48-5	206-376-4	1,2
Nitric acid		Non-active substance	7697-37-2	231-714-2	18,0

Meta spc 4

1. Meta spc 4 administrative information

1.1. Meta SPC 4 identifier

Identifier

Meta SPC 4

1.2. Suffix to the authorisation number

Number

1-4

1.3. Product type(s)

Product type(s)

PT04 – Food and feed area (Disinfectants)

2. Meta spc 4 composition

2.1. Qualitative and quantitative information on the composition of the meta SPC 4

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Min	Max
Octanoic acid		Active Substance	124-07-2	204-677-5	1,8	1,8
Decanoic acid		Active Substance	334-48-5	206-376-4	1,2	1,2
Sulfuric acid		Non-active substance	7664-93-9	231-639-5	4,68	4,68
Propionic acid		Non-active substance	79-09-4	201-176-3	0,0	0,0
Phosphoric acid		Non-active substance	7664-38-2	231-633-2	0,0	0,0
Nitric acid		Non-active substance	7697-37-2	231-714-2	0,0	0,0
Methane sulfonic acid		Non-active substance	75-75-2	200-898-6	20,3	20,3
Glycolic acid		Non-active substance	79-14-1	201-180-5	0,0	0,0
Lactic acid		Non-active substance	79-33-4	201-196-2	0,0	0,0
Citric acid		Non-active substance	77-92-9	201-069-1	0,0	0,0

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

Formulation(s)

SL – Soluble concentrate

3. Hazard and precautionary statements of the meta spc 4

Hazard statements

May be corrosive to metals.Causes severe skin burns and eye damage.May cause respiratory irritation.

Precautionary statements

Do not breathe vapours.Wear protective clothing.Wear eye protection.Wear protective gloves.Wear face protection.IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.Immediately call a POISON CENTER.Immediately call a doctor.IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.Keep only in original container.Store in a well-ventilated place.Keep container tightly closed.Absorb spillage to prevent material damage.Dispose of contents in accordance with local/regional/national/international regulations.

4. Authorised use(s) of the meta spc 4

4.1. Use description

Table 8
Product type	PT04 – Food and feed area (Disinfectants)
Where relevant, an exact description of the authorised use	-
Target organism(s) (including development stage)	BacteriaYeasts
Field(s) of use	IndoorIn food and feed areas
Application method(s)	Closed systemFor disinfection of pipes, tanks, and other parts of the closed system.Biocidal product (semi-)automatically dosed in the CIP vessel (either by volume or conductivity measurements)Circulation in a closed CIP system
Application rate(s) and frequency	For an effect on bacteria and on yeasts: Dilution rate: 1,5 %v/v. In case of outbreaks of Pediococcus damnosus, the products must be used at 2 %. Contact time: minimum 15 minutes at +4 °C and above, up to +20– 25 °C.
Category(ies) of users	IndustrialTrained professional
Pack sizes and packaging material	Jerrycan (PE-HD), containing: 10 to 12,5 kg.Jerrycan (PE-HD), containing: 20 to 25 kg.Drums (PE-HD) containing 200 to 250 kg.Containers (PE-HD) containing 600 to 750 kg.IBC (PE-HD) containing 1100 to 1250 kgBulk delivery.

4.1.1. Use-specific instructions for use

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

4.1.2. Use-specific risk mitigation measures

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

During the mixing, loading and application phase:

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 USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4. OF THE META SPC 4

5.1. Instructions for use

For an effect on bacteria and on yeasts

Rinsing and cleaning before disinfection:

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

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

Disinfecting cycle:

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

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

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

Final rinsing with drinking water

5.2. Risk mitigation measures

Use in well-ventilated places.

During the mixing, loading and application phases:

Wear a protective coverall. Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information). Use eye protection during handling of the product. Wear face protection.

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

Particulars of likely direct or indirect adverse effects:

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

First aid instructions:

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

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

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

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

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

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

NEVER LEAVE THE AFFECTED INDIVIDUAL UNATTENDED!

Advice for medical and healthcare personnel:

In case of ingestion consider performing an endoscopic procedure.

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

Symptomatic and supportive treatment.

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

Emergency measures to protect the environment:

Prevent entry into sewers and public waters.

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

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

Keep only in the original packaging tightly closed in a cool and well-ventilated place

Keep the product away from direct sunlight, source of heat and ignition.

The product must be stored at temperatures below +30 °C.

Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) nor down the drains

Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

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

Storage conditions:

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

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

Handle in accordance with good industrial hygiene and safety procedures.

Packaging material: Use approved materials suitable for corrosive liquids.

Shelf-life: 12 months in the original packaging.

Trade name(s)	SOPURCLEAN CIP OP
Authorisation number	EU-0021157-0008 1-4
Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Octanoic acid		Active Substance	124-07-2	204-677-5	1,8
Decanoic acid		Active Substance	334-48-5	206-376-4	1,2
Sulfuric acid		Non-active substance	7664-93-9	231-639-5	4,68
Methane sulfonic acid		Non-active substance	75-75-2	200-898-6	20,3