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Document 32026R0287

Commission Implementing Regulation (EU) 2026/287 of 6 February 2026 granting a Union authorisation for the biocidal product family Divodes FG Family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

C/2026/633

OJ L, 2026/287, 9.2.2026, ELI: http://data.europa.eu/eli/reg_impl/2026/287/oj (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

Legal status of the document In force

ELI: http://data.europa.eu/eli/reg_impl/2026/287/oj

European flag

Official Journal
of the European Union

EN

L series


2026/287

9.2.2026

COMMISSION IMPLEMENTING REGULATION (EU) 2026/287

of 6 February 2026

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

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

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

Whereas:

(1)

On 18 April 2018, Diversey Europe Operations B.V submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘Divodes FG Family’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-FK051028-46 in the Register for Biocidal Products.

(2)

‘Divodes FG Family’ contains propan-1-ol and propan-2-ol as the active substances, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 2 and 4.

(3)

On 6 September 2024, 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 Agency.

(4)

On 21 March 2025, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Divodes FG Family’ 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 ‘Divodes FG family’ 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(6) of that Regulation.

(6)

On 8 April 2025, 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 the biocidal product family ‘Divodes FG Family’.

(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-0034601-0000 is hereby granted to Diversey Europe Operations B.V. for the making available on the market and use of the biocidal product family ‘Divodes FG Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 1 March 2026 until 29 February 2036.

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, 6 February 2026.

For the Commission

The President

Ursula VON DER LEYEN


(1)   OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(2)  Opinion of 27 February 2025 on the Union authorisation of the biocidal product family ‘Divodes FG Family’ (ECHA/BPC/461/2025), https://echa.europa.eu/opinions-on-union-authorisation.


ANNEX

Summary of product characteristics for a biocidal product family

Divodes FG family

Product type(s)

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

PT04: Food and feed area

Authorisation number: EU-0034601-0000

R4BP asset number: EU-0034601-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

Name

Divodes FG family

1.2.   Product type(s)

Product type(s)

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

PT04: Food and feed area

1.3.   Authorisation holder

Name and address of the authorisation holder

Name

Diversey Europe Operations B.V.

Address

De Corridor 4 (Regulatory team) 3621 ZB Breukelen NL

Authorisation number

 

EU-0034601-0000

R4BP asset number

 

EU-0034601-0000

Date of the authorisation

 

1 March 2026

Expiry date of the authorisation

 

29 February 2036

1.4.   Manufacturer(s) of the product

Name of manufacturer

Diversey Europe Operations B.V.

Address of manufacturer

De Corridor 4 (Regulatory team) 3621 ZB Breukelen Netherlands (the)

Location of manufacturing sites

Diversey Europe Operations B.V. site 1 Diversey España Production S.L.U., Avenida Conde Duque 5, 7 y 9, Poligono Industrial La Postura 28343 Valdemoro (Madrid) Spain

Diversey Europe Operations B.V. site 2 Diversey Italy Production Srl, Strada Statale 235 I - 26010 Bagnolo Cremasco (CR) Italy

Diversey Europe Operations B.V. site 3 Diversey UK Production Limited, Cotes Park Industrial Estate DE55 4PA Somercotes, Alfreton United Kingdom of Great Britain and Northern Ireland (the)

Diversey Europe Operations B.V. site 4 Diversey Netherlands Production BV, Rembrandtlaan 414 7545 ZW Enschede Netherlands (the)

Diversey Europe Operations B.V. site 5 Diversey Germany Production OHG, Morschheimer Strasse 12 D-67292 Kirchheimbolanden Germany


Name of manufacturer

Orvema B.V.

Address of manufacturer

Westkanaaldijk 26-I 3606 AM Maarssen Netherlands (the)

Location of manufacturing sites

Orvema B.V. site 1 Westkanaaldijk 26-I 3606 AM Maarssen Netherlands (the)


Name of manufacturer

Brenntag GmbH

Address of manufacturer

Am Röhrenwerk 46 47259 Duisburg Germany

Location of manufacturing sites

Brenntag GmbH site 1 Am Röhrenwerk 46 47259 Duisburg Germany


Name of manufacturer

Brenntag SA

Address of manufacturer

Zone d' Activités les Sauzets 07340 Andance France

Location of manufacturing sites

Brenntag SA site 1 Zone d’Activités les Sauzets 07340 Andance France


Name of manufacturer

Brenntag Nederland B.V.

Address of manufacturer

Chemieweg 9, Havennummer 4208 3197 KC Botlek Rotterdam Netherlands (the)

Location of manufacturing sites

Brenntag Nederland B.V. site 1 Chemieweg 9, Havennummer 4208 3197 KC Botlek Rotterdam Netherlands (the)


Name of manufacturer

Brenntag Schweizerhall AG

Address of manufacturer

Elsässerstrasse 229/245 4056 Basel Switzerland

Location of manufacturing sites

Brenntag Schweizerhall AG site 1 Elsässerstrasse 229/245 4056 Basel Switzerland


Name of manufacturer

Cheport spol s.r.o.

Address of manufacturer

Lhotsko 93 76312 Vizovice Czechia

Location of manufacturing sites

Cheport spol s.r.o. site 1 Lhotsko 93 76312 Vizovice Czechia


Name of manufacturer

Ionic Products Ltd

Address of manufacturer

Blaris Industrial Estate, Altona Road BT27 5QB Lisburn, Northern Ireland United Kingdom of Great Britain and Northern Ireland (the)

Location of manufacturing sites

Ionic Products Ltd site 1 Blaris Industrial Estate, Altona Road BT27 5QB Lisburn, Northern Ireland United Kingdom of Great Britain and Northern Ireland (the)


Name of manufacturer

Multifill B.V.

Address of manufacturer

Constructieweg 25a, P.O. Box 367 3640 AJ Mijdrecht Netherlands (the)

Location of manufacturing sites

Multifill B.V. site 1 Constructieweg 25a, P.O. Box 367 3640 AJ Mijdrecht Netherlands (the)


Name of manufacturer

Pluswipes Ltd

Address of manufacturer

Pywell Road, Willowbrook East Industrial Estate NN17 5XJ Corby United Kingdom of Great Britain and Northern Ireland (the)

Location of manufacturing sites

Pluswipes Ltd site 1 Pywell Road, Willowbrook East Industrial Estate NN17 5XJ Corby United Kingdom of Great Britain and Northern Ireland (the)

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

Active substance

Propan-1-ol

Name of manufacturer

BASF SE

Address of manufacturer

Carl-Bosch-Str. 38 67056 Ludwigshafen Germany

Location of manufacturing sites

BASF SE site 1 Carl-Bosch-Str. 38 67056 Ludwigshafen Germany


Active substance

Propan-1-ol

Name of manufacturer

OXEA Corporation

Address of manufacturer

2001 FM 3057 TX 77414 Bay City United States (the)

Location of manufacturing sites

OXEA Corporation site 1 2001 FM 3057 TX 77414 Bay City United States (the)


Active substance

Propan-2-ol

Name of manufacturer

SASOL Solvents Germany GmbH

Address of manufacturer

Anckelmannsplatz D-20537 Hamburg Germany

Location of manufacturing sites

SASOL Solvents Germany GmbH site 1 Shamrockstrasse 88 D-44623 Herne Germany

SASOL Solvents Germany GmbH site 2 Römerstr. 733 D-47443 Moers Germany


Active substance

Propan-2-ol

Name of manufacturer

Shell Chemicals Europe B.V.

Address of manufacturer

Postbus 2334 3000 CH Rotterdam Netherlands (the)

Location of manufacturing sites

Shell Chemicals Europe B.V. site 1 Shell Nederland Chemie BV/Shell Nederland Raffinaderij B.V., Vondelingenweg 601 3196 KK Rotterdam-Pernis Netherlands (the)


Active substance

Propan-2-ol

Name of manufacturer

Exxon Mobil Chemicals

Address of manufacturer

Hermeslaan 2 1831 Machelen Belgium

Location of manufacturing sites

Exxon Mobil Chemicals site 1 ExxonMobil’s Baton Rouge Refinery and Chemical Plant, 4045 Scenic Hwy LA 70805 Baton Rouge United States (the)

Exxon Mobil Chemicals site 2 Esso Refinery Fawley SO45 1TX Southampton United Kingdom of Great Britain and Northern Ireland (the)


Active substance

Propan-2-ol

Name of manufacturer

Novapex

Address of manufacturer

21 Chemin de la Sauvegarde - 21 Ecully Parc - CS 33167 69134 Écully Cedex France

Location of manufacturing sites

Novapex site 1 Novapex SAS Usine de Rousillon, Rue Gaston Monmousseau, Saint Maurice l’Exil 38556 Cédex 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 (%)

Propan-1-ol

 

Active substance

71-23-8

200-746-9

52,2 - 52,2 % (w/w)

Propan-2-ol

 

Active substance

67-63-0

200-661-7

17,5 - 17,5 % (w/w)

2.2.   Type(s) of formulation

Formulation type(s)

AL Any other liquid

XX Impregnated wipes

PART II

SECOND INFORMATION LEVEL META SPC(S)

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

Identifier

Meta SPC: Meta 1: Divodes FG VT29

1.2.   Suffix to the authorisation number

Number

1-1

1.3.   Product type(s)

Product type(s)

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

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 (%)

Propan-1-ol

 

Active substance

71-23-8

200-746-9

52,2 - 52,2 % (w/w)

Propan-2-ol

 

Active substance

67-63-0

200-661-7

17,5 - 17,5 % (w/w)

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

Formulation type(s)

AL Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements

H226: Flammable liquid and vapour.

H318: Causes serious eye damage.

H336: May cause drowsiness or dizziness.

EUH066: Repeated exposure may cause skin dryness or cracking.

Precautionary statements

P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P261: Avoid breathing vapours.

P271: Use only outdoors or in a well-ventilated area.

P280: Wear eye/face protection.

P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].

P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.

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 centre or doctor/physician.

P312: Call a POISON CENTER if you feel unwell.

P403+P235: Store in a well-ventilated place. Keep cool.

P405: Store locked up.

P501: Dispose of contents a hazardous waste disposal service in accordance with the statutory regulations.

P501: Dispose of container a hazardous waste disposal service in accordance with the statutory regulations.

4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Use # 1 – Small scale disinfection - Trigger spray - PT 2 - Industrial and healthcare (clean)

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Common name: Fungi

Common name: Viruses (limited spectrum virucidal activity)

Field(s) of use

indoor use

Ready to use disinfectant for clean hard non-porous surfaces in industrial areas (e.g. laboratories, pharmaceutical and cosmetic industries) and healthcare.

Application method(s)

Method: spraying

Detailed description:

Disinfection using a trigger spray: Ready to use for spraying on cleaned surfaces.

Application rate(s) and frequency

Application Rate: 25 ml/m2 No dilution required

Number and timing of application:

Use frequencies:

Laboratories: Up to 10 times per day

Cleanrooms (ventilation rate 8 per h): Up to 20 times per day

Cleanrooms (ventilation rate 20 per h): Up to 40 times per day

Pharmaceutical and cosmetic: Up to 80 times per day

Healthcare (e.g. hospitals and medical practices): Up to 8 times per day

Can be used in areas at room temperature or at low temperature of 4 °C (cold storage rooms)

Category(ies) of users

industrial

professional

Pack sizes and packaging material

Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.

Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.

4.1.1.   Use-specific instructions for use

Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Spray on cleaned surface (25 ml/m2) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (See contact times below). Let air dry.

Contact times

Pre-cleaned surface at room temperature:

Bacteria and yeasts: 30 seconds

Fungi and viruses (limited spectrum virucidal activity): 5 minutes

Pre-cleaned surface in cosmetic industry and healthcare at room temperature:

Bacteria and yeasts: 30 seconds

Fungi and viruses (limited spectrum virucidal activity): 5 minutes

Pre-cleaned surface at 4 °C:

Bacteria and yeasts: 30 seconds

4.1.2.   Use-specific risk mitigation measures

In laboratories, cleanrooms and pharmaceutical and cosmetic industries and hospitals:

Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)

The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)

Unprotected persons shall be kept away from treated areas until surfaces are dry. (N-188)

In medical practices:

Ensure that the application is carried out in areas with a minimum ventilation of 5 air changes per hour. (N-29)

Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)

The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)

Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)

The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.

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

Not applicable

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

Not applicable

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

Not applicable

4.2.   Use description

Table 2

Use # 2 – Small scale disinfection - Trigger spray – PT 2 – Institutional and public areas – Professional use (clean)

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Common name: Fungi

Common name: Viruses (limited spectrum virucidal activity)

Field(s) of use

indoor use

Ready to use disinfectant for clean hard non-porous surfaces in institutional (e.g. educational institutions) and public areas.

Application method(s)

Method: spraying

Detailed description:

Disinfection using a trigger spray: Ready to use for spraying on cleaned surfaces.

Application rate(s) and frequency

Application Rate: 25 ml/m2 No dilution required

Number and timing of application:

Use up to 10 times per day

Can be used in areas at room temperature or at low temperature of 4 °C (cold storage rooms)

Category(ies) of users

industrial

professional

Pack sizes and packaging material

Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.

Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.

4.2.1.   Use-specific instructions for use

Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Spray on cleaned surface (25 ml/m2) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (See contact times below). Let air dry.

Contact times

Pre-cleaned surface at room temperature:

Bacteria and yeasts: 30 seconds

Fungi and viruses (limited spectrum virucidal activity): 5 minutes

Pre-cleaned surface at 4 °C:

Bacteria and yeasts: 30 seconds

4.2.2.   Use-specific risk mitigation measures

In institutional and public areas:

The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)

Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)

Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)

The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.

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

Not applicable

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

Not applicable

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

Not applicable

4.3.   Use description

Table 3

Use # 3 – Small scale disinfection - Trigger spray - PT 4 - Food and beverage industry (clean)

Product type

PT04: Food and feed area

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Common name: Fungi

Common name: Viruses

Field(s) of use

indoor use

Ready to use disinfectant for clean hard non-porous surfaces (including indirect food contact) in the food and beverage industries (including kitchens, beverage, meat industries).

Application method(s)

Method: spraying

Detailed description:

Disinfection using a trigger spray: Ready to use for spraying on cleaned surfaces.

Application rate(s) and frequency

Application Rate: 25 ml/m2 No dilution required

Number and timing of application:

Use up to 10 times per day

Can be used in areas at room temperature or at low temperature of 4°C (cold storage rooms)

Category(ies) of users

industrial

professional

Pack sizes and packaging material

Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.

Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.

4.3.1.   Use-specific instructions for use

Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Spray on cleaned surface (25 ml/m2) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.

Contact times

Pre-cleaned surface in food and beverage industry at room temperature:

Bacteria and yeasts: 30 seconds

Fungi and viruses: 5 minutes

Pre-cleaned surface at 4 °C:

Bacteria and yeasts: 30 seconds

4.3.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)

The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)

Unprotected persons shall be kept away from treated areas until surfaces are dry. (N-188)

The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.

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

Not applicable

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

Not applicable

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

Not applicable

4.4.   Use description

Table 4

Use # 4 – Small scale disinfection - Trigger spray - PT 2 - Industrial and healthcare

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Field(s) of use

indoor use

Ready to use disinfectant for hard non-porous surfaces in industrial areas (e.g. laboratories, pharmaceutical and cosmetic industries) and healthcare.

Application method(s)

Method: spraying

Detailed description:

Disinfection using a trigger spray: Ready to use for spraying on surfaces.

Application rate(s) and frequency

Application Rate: 25 mL/m2 No dilution required

Number and timing of application:

Use frequencies:

Laboratories: Up to 10 times per day

Cleanrooms (ventilation rate 8 per h): Up to 20 times per day

Cleanrooms (ventilation rate 20 per h): Up to 40 times per day

Pharmaceutical and cosmetic: Up to 80 times per day

Healthcare (e.g. hospitals and medical practices): Up to 8 times per day

Use at room temperature

Category(ies) of users

industrial

professional

Pack sizes and packaging material

Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.

Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.

4.4.1.   Use-specific instructions for use

Spray on surface (25 ml/m2) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.

Contact times

Surface (industrial including cosmetics industry and healthcare):

Bacteria and yeasts: 30 seconds

4.4.2.   Use-specific risk mitigation measures

In laboratories, cleanrooms and pharmaceutical and cosmetic industries and hospitals:

Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)

The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)

Unprotected persons shall be kept away from treated areas until surfaces are dry. (N-188)

In medical practices:

Ensure that the application is carried out in areas with a minimum ventilation of 5 air changes per hour. (N-29)

Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)

The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)

Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)

The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.

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

Not applicable

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

Not applicable

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

Not applicable

4.5.   Use description

Table 5

Use # 5 – Small scale disinfection - Trigger spray - PT 2 - Institutional and public - Professional use

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Field(s) of use

indoor use

Ready to use disinfectant for hard non-porous surfaces in institutional (e.g. educational institutions) and public areas

Application method(s)

Method: spraying

Detailed description:

Disinfection using a trigger spray: Ready to use for spraying on surfaces.

Application rate(s) and frequency

Application Rate: 25 ml/m2 No dilution required

Number and timing of application:

Use up to 10 times per day

Can be used in areas at room temperature or at low temperature of 4 °C (cold storage rooms)

Category(ies) of users

industrial

professional

Pack sizes and packaging material

Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.

Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.

4.5.1.   Use-specific instructions for use

Spray on surface (25 ml/m2) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.

Contact times

Surface at room temperature:

Bacteria and yeasts: 30 seconds

Surface at 4 °C:

Bacteria and yeasts: 30 seconds

4.5.2.   Use-specific risk mitigation measures

In institutional and public areas:

The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)

Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)

Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)

The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.

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

Not applicable

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

Not applicable

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

Not applicable

4.6.   Use description

Table 6

Use # 6 – Small scale disinfection - Trigger spray - PT 4 - Food industry

Product type

PT04: Food and feed area

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Field(s) of use

indoor use

Ready to use disinfectant for hard non-porous surfaces (e.g. kitchens)

Application method(s)

Method: spraying

Detailed description:

Disinfection using a trigger spray: Ready to use for spraying on surfaces.

Application rate(s) and frequency

Application Rate: 25 ml/m2 No dilution required

Number and timing of application:

Use up to 10 times per day

Can be used in areas at room temperature or at low temperature of 4 °C (cold storage rooms)

Category(ies) of users

industrial

professional

Pack sizes and packaging material

Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.

Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.

4.6.1.   Use-specific instructions for use

Spray on surface (25 ml/m2) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.

Contact times

Surface (generic) at room temperature:

Bacteria and yeasts: 30 seconds

Surface at 4 °C:

Bacteria and yeasts: 30 seconds

4.6.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)

The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)

Unprotected persons shall be kept away from treated areas until surfaces are dry. (N-188)

The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.

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

Not applicable

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

Not applicable

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

Not applicable

4.7.   Use description

Table 7

Use # 7 – Small scale disinfection - Trigger spray - PT 4 - Food and beverage industry (specific claims)

Product type

PT04: Food and feed area

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Common name: Fungi

Field(s) of use

indoor use

Ready to use disinfectant for hard non-porous surfaces (e.g. kitchens, dairies, and food and beverage industries).

Application method(s)

Method: spraying

Detailed description:

Disinfection using a trigger spray: Ready to use for spraying on surfaces.

Application rate(s) and frequency

Application Rate: 25 ml/m2 No dilution required

Number and timing of application:

Use up to 10 times per day

Can be used in areas at room temperature or at low temperature of 4 °C (cold storage rooms)

Category(ies) of users

industrial

professional

Pack sizes and packaging material

Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.

Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.

4.7.1.   Use-specific instructions for use

Spray on surface (25 ml/m2) and make sure to wet surfaces completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.

Contact times

Surface in beverage industry at room temperature:

Bacteria and yeasts: 30 seconds

Fungi: 5 minutes

Surface in meat industry at room temperature:

Bacteria and yeasts: 30 seconds

Surface in dairy industry at room temperature:

Bacteria and yeasts: 5 minutes

Surface in meat industry at 4 °C:

Bacteria and yeasts: 30 seconds

4.7.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)

The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)

Unprotected persons shall be kept away from treated areas until surfaces are dry. (N-188)

The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.

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

Not applicable

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

Not applicable

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

Not applicable

4.8.   Use description

Table 8

Use # 8 – Pressurised spraying - PT 4

Product type

PT04: Food and feed area

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Common name: Fungi

Common name: Viruses

Field(s) of use

indoor use

Ready to use disinfectant for hard non-porous surfaces in dairy, beverage and processed food industries.

Application method(s)

Method: spraying

Detailed description:

Disinfection using pressurised spraying: Ready to use for spraying on surfaces.

Application rate(s) and frequency

Application Rate: 50 ml/m2 No dilution required

Number and timing of application:

Use frequency:

End of shift disinfection: Once per day

Mid-shift disinfection: Up to 3 times per day

Can be used in areas at room temperature or at low temperature of 4 °C (cold storage rooms).

Category(ies) of users

industrial

professional

Pack sizes and packaging material

Rigid container (screw cap) (HDPE): 0,75, 1, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L

4.8.1.   Use-specific instructions for use

Pre-cleaned surface:

Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Spray on cleaned surface (50 ml/m2) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.

Contact times

Pre-cleaned surface in food and beverage industry at room temperature:

Bacteria and yeasts: 30 seconds

Fungi and viruses: 5 minutes

Pre-cleaned surface at 4 °C:

Bacteria and yeasts: 30 seconds

Dirty surface:

Spray on surface (50 ml/m2) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.

Contact times

Dirty surface (generic) at room temperature:

Bacteria and yeasts: 30 seconds

Dirty surface in beverage industry at room temperature:

Bacteria and yeasts: 30 seconds

Fungi: 5 minutes

Dirty surface in meat industry at room temperature:

Bacteria and yeasts: 30 seconds

Fungi: 5 minutes

Dirty surface in dairy industry at room temperature:

Bacteria and yeasts: 5 minutes

Dirty surface in meat industry at 4 °C:

Bacteria and yeasts: 30 seconds

4.8.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information). (N-78)

The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)

Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)

The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.

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

Not applicable

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

Not applicable

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

Not applicable

4.9.   Use description

Table 9

Use # 9 – Pressurised spraying - PT 2

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Common name: Fungi

Common name: Viruses (limited spectrum virucidal activity)

Field(s) of use

indoor use

Ready to use disinfectant for hard non-porous surfaces in industrial areas (e.g. laboratories and pharmaceutical and cosmetic industries).

Application method(s)

Method: spraying

Detailed description:

Disinfection using pressurised spraying: Ready to use for spraying on surfaces.

Application rate(s) and frequency

Application Rate: 50 ml/m2 No dilution required

Number and timing of application:

Use frequency:

End of shift disinfection: Once per day

Mid-shift disinfection: Up to 3 times per day

Can be used in areas at room temperature or at low temperature of 4 °C (cold storage rooms).

Category(ies) of users

industrial

professional

Pack sizes and packaging material

Rigid container (screw cap) (HDPE): 0,75, 1, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L

4.9.1.   Use-specific instructions for use

Pre-cleaned surface:

Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Spray on cleaned surface (50 ml/m2) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.

Contact times

Pre-cleaned surface (including cosmetics industry):

Bacteria and yeasts: 30 seconds

Fungi and viruses (limited spectrum virucidal activity): 5 minutes

Pre-cleaned surface at 4 °C:

Bacteria and yeasts: 30 sec

Dirty surface:

Spray on surface (50 ml/m2) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.

Contact times

Dirty surface (including cosmetics industry):

Bacteria and yeasts: 30 seconds

Dirty surface at 4 °C:

Bacteria and yeasts: 30 seconds

4.9.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).

The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)

Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)

The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.

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

Not applicable

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

Not applicable

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

Not applicable

4.10.   Use description

Table 10

Use # 10 – Container opening disinfection - PT 4

Product type

PT04: Food and feed area

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Common name: Fungi

Common name: Viruses

Field(s) of use

indoor use

Ready to use disinfectant for container openings with a valve in the food and beverage industry.

Application method(s)

Method: spraying

Detailed description:

Disinfection using automated spraying equipment: Ready to use for spraying container openings.

Application rate(s) and frequency

Application Rate: 1 - 10 ml/ container opening No dilution required

Number and timing of application:

Use frequency: Up to 600 containers per hour

Can be used in areas at room temperature or at low temperature of 4 °C (cold storage rooms).

Category(ies) of users

industrial

professional

Pack sizes and packaging material

Rigid container (screw cap) (HDPE): 0,75, 1, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L

4.10.1.   Use-specific instructions for use

Automated spraying on container opening with valve (1 - 10 ml/ container opening). Make sure to wet the surface completely. Allow to take effect for the appropriate contact time (see contact times below). Let air dry.

Contact times

Pre-cleaned surface in food and beverage industry at room temperature:

Bacteria and yeasts: 30 seconds

Fungi and viruses: 5 minutes

Pre-cleaned surface at 4 °C:

Bacteria and yeasts: 30 seconds

Dirty surface (generic) at room temperature:

Bacteria and yeasts: 30 seconds

Dirty surface in beverage industry at room temperature:

Bacteria and yeasts: 30 seconds

Fungi: 5 minutes

Dirty surface in meat industry at room temperature:

Bacteria and yeasts: 30 seconds

Dirty surface in dairy industry at room temperature:

Bacteria and yeasts: 5 minutes

Dirty surface in meat industry at 4 °C:

Bacteria and yeasts: 30 seconds

4.10.2.   Use-specific risk mitigation measures

The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent) (N-70)

Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).

Unprotected persons shall be kept away from treated areas until surfaces are dry. (N-188)

The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.

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

Not applicable

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

Not applicable

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

Not applicable

4.11.   Use description

Table 11

Use # 12 – Glove disinfection - PT 2 & PT 4

Product type

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

PT04: Food and feed area

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Field(s) of use

indoor use

Ready to use disinfectant for non-porous gloves worn by professional workers in healthcare institutions, laboratories and the pharmaceutical, cosmetic, dairy, beverage and processed food industries.

Application method(s)

Method: spraying

Detailed description:

Ready to use disinfectant for clean non-porous gloves.

Application rate(s) and frequency

Application Rate: 3 ml (both hands) No dilution required

Number and timing of application:

Use up to 10 times per day.

Use temperature: room temperature

Category(ies) of users

industrial

professional

Pack sizes and packaging material

Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.

Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.

4.11.1.   Use-specific instructions for use

Apply directly onto clean non-porous gloves, distribute evenly and allow to take effect for 30 seconds to be effective for bacteria and yeasts. Make sure to wet the surface completely.

Do not use for disinfection of medical gloves falling under Regulation (EU) 2017/745

4.11.2.   Use-specific risk mitigation measures

The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)

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

Not applicable

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

Not applicable

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

Not applicable

4.12.   Use description

Table 12

Use # 13 – Small scale disinfection - Trigger spray – PT 2 – Veterinary practices

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Field(s) of use

indoor use

Ready to use disinfectant for general hard non-porous surfaces in veterinary practices.

Application method(s)

Method: spraying

Detailed description:

Disinfection using a trigger spray: Ready to use for spraying on surfaces.

Application rate(s) and frequency

Application Rate: 25 ml/m2 No dilution required

Number and timing of application:

Use up to 10 times per day

Use at room temperature

Category(ies) of users

professional

Pack sizes and packaging material

Rigid container (trigger sprayer top) (HDPE): 0,75, 1, 1,5, 2 L.

Rigid container (screw cap) (HDPE): 0,75, 1, 1,5, 2, 5, 10, 20, 50, 100, 200, 900, 950, 1 000 L.

4.12.1.   Use-specific instructions for use

Spray on surface (25 ml/m2) and make sure to wet the surface completely. Allow to take effect for the appropriate contact time (See contact times below). Let air dry.

Contact times

Surface:

Bacteria and yeasts: 5 minutes

4.12.2.   Use-specific risk mitigation measures

Ensure that the application is carried out in areas with a minimum ventilation of 5 air changes per hour. (N-29)

The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)

Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).

Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)

The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.

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

Not applicable

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

Not applicable

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

Not applicable

5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use

See use specific instructions in the individual uses.

5.2.   Risk mitigation measures

See specific risk mitigation measures in the individual use.

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. Call a POISON CENTRE or a doctor.

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

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

Stability and Reactivity

Reactivity: No reactivity hazards known under normal storage and use conditions.

Chemical stability: Stable under normal storage and use conditions.

Possibility of hazardous reactions: No hazardous reactions known under normal storage and use conditions.

Conditions to avoid: None known under normal storage and use conditions.

Incompatible materials: None known under normal use conditions.

Hazardous decomposition products: None known under normal storage and use conditions.

Environmental precautions

The product shall not reach sewage water or drainage ditch undiluted or unneutralised.

Do not allow to enter drainage system, surface or groundwater. Dilute with plenty of water.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, universal binders, sawdust).

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

Dispose according to national or local regulations.

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

36 months shelf life.

Store below 30 °C.

6.   OTHER INFORMATION

The full titles of the EN standards referenced in sections ‘Use-specific risk mitigation measures’ are:

EN 374 – Protective gloves against dangerous chemicals and micro-organisms

EN 166 – Personal Eye Protection - Specifications

Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).

With respect to the ‘Category (ies) of users’ note: ‘Professionals (including industrial users)’ means trained professionals if this is required by national legislation.

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)

Suma Quicksan D4.3

Market area: EU

Suma Quicksan

Market area: EU

HORECA Select DESINFEKTIONSSPRAY

Market area: EU

Divodes FG

Market area: EU

Divodes FG VT 29

Market area: EU

ClearKlens Divodes FG

Market area: EU

ClearKlens FG

Market area: EU

DOMESTOS QuickGuard

Market area: EU

GLORIX QuickGuard

Market area: EU

KLINEX QuickGuard

Market area: EU

LYSOFORM QuickGuard

Market area: EU

SAVO QuickGuard

Market area: EU

CIF QuickGuard

Market area: EU

VISS QuickGuard

Market area: EU

JIF QuickGuard

Market area: EU

FLORASZEPT QuickGuard

Market area: EU

ANDY QuickGuard

Market area: EU

SUPERANDY QuickGuard

Market area: EU

ANDYSAN QuickGuard

Market area: EU

Authorisation number

 

EU-0034601-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-1-ol

 

Active substance

71-23-8

200-746-9

52,2 % (w/w)

Propan-2-ol

 

Active substance

67-63-0

200-661-7

17,5 % (w/w)

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

Identifier

Meta SPC: Meta 2: Divodes FG Wipes

1.2.   Suffix to the authorisation number

Number

1-2

1.3.   Product type(s)

Product type(s)

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

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 (%)

Propan-1-ol

 

Active substance

71-23-8

200-746-9

52,2 - 52,2 % (w/w)

Propan-2-ol

 

Active substance

67-63-0

200-661-7

17,5 - 17,5 % (w/w)

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

Formulation type(s)

Impregnated wipes

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

Hazard statements

H226: Flammable liquid and vapour.

H318: Causes serious eye damage.

H336: May cause drowsiness or dizziness.

EUH066: Repeated exposure may cause skin dryness or cracking.

Precautionary statements

P101: If medical advice is needed, have product container or label at hand.

P102: Keep out of reach of children.

P103: Read carefully and follow all instructions.

P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

P261: Avoid breathing vapours.

P271: Use only outdoors or in a well-ventilated area.

P280: Wear eye/face protection.

P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower].

P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.

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 centre or doctor/physician.

P312: Call a POISON CENTER if you feel unwell.

P403+P235: Store in a well-ventilated place. Keep cool.

P405: Store locked up.

P501: Dispose of contents a hazardous waste disposal service in accordance with the statutory regulations.

P501: Dispose of container a hazardous waste disposal service in accordance with the statutory regulations.

4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description

Table 1

Use # 1 – Small scale disinfection - Wipes - PT 2 Industrial and healthcare - Professional use

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Common name: Fungi

Common name: Viruses (limited spectrum virucidal activity)

Field(s) of use

indoor use

Ready to use wipe for clean hard non-porous surfaces in industrial areas (e.g. laboratories and cosmetics and pharmaceutical industries) and healthcare.

Application method(s)

Method: wiping

Detailed description:

Ready to use wipe for clean hard non-porous surfaces

Application rate(s) and frequency

Application Rate: For wipes with size 133 × 200 mm: use 1 wipe per m2; For wipes with size 200 × 195 mm: use 1 wipe per 1,75 m2; For wipes with size 200 × 390 mm: use 1 wipe per 2,5 m2 No dilution required

Number and timing of application:

Use up to 20 times per day.

Use at room temperature.

Category(ies) of users

industrial

professional

Pack sizes and packaging material

Rigid container (snap top cap with/without Aluminium induction seal or PET induction seal) (PP): 150, 200, 500, 1 000 wipes

4.1.1.   Use-specific instructions for use

Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Open the lid, take a single wipe, close the lid. Only use wet wipes. Wipe the surface and allow to take effect for the appropriate contact time (see contact times below). Make sure to wet the surface completely. Let air dry. No rinsing.

Contact times

Pre-cleaned surface:

Bacteria and yeasts: 30 seconds

Fungi and viruses (limited spectrum virucidal activity): 5 minutes

Pre-cleaned surface in cosmetic industry and healthcare:

Bacteria and yeasts: 30 seconds

Fungi and viruses (limited spectrum virucidal activity): 5 minutes

4.1.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).

Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)

The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.

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

Not applicable

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

Not applicable

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

Not applicable

4.2.   Use description

Table 2

Use # 2 – Small scale disinfection - Wipes - PT 2 Institutional and public areas - Professional use

Product type

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

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Common name: Fungi

Common name: Viruses (limited spectrum virucidal activity)

Field(s) of use

indoor use

Ready to use wipe for clean hard non- porous surfaces in institutional (e.g. educational institutions) and public areas.

Application method(s)

Method: wiping

Detailed description:

Ready to use wipe for clean hard non-porous surfaces

Application rate(s) and frequency

Application Rate: For wipes with size 133 × 200 mm: use 1 wipe per m2; For wipes with size 200 × 195 mm: use 1 wipe per 1,75 m2; For wipes with size 200 × 390 mm: use 1 wipe per 2,5 m2 No dilution required

Number and timing of application:

Use up to 10 times per day.

Use at room temperature.

Category(ies) of users

industrial

professional

Pack sizes and packaging material

Rigid container (snap top cap with/without Aluminium induction seal or PET induction seal) (PP): 150, 200, 500, 1 000 wipes

4.2.1.   Use-specific instructions for use

Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Open the lid, take a single wipe, close the lid. Only use wet wipes. Wipe the surface and allow to take effect for the appropriate contact time (see contact times below). Make sure to wet the surface completely. Let air dry. No rinsing.

Contact times

Pre-cleaned surface:

Bacteria and yeasts: 30 seconds

Fungi and viruses (limited spectrum virucidal activity): 5 minutes

4.2.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).

Unprotected persons shall be kept away during application and from treated areas until surfaces are dry. (modified N-188)

The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.

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

Not applicable

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

Not applicable

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

Not applicable

4.3.   Use description

Table 3

Use # 3 – Small scale disinfection - Wipes - PT 2 & PT 4 Institutional and public areas - General public (Non-professional use)

Product type

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

PT04: Food and feed area

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Common name: Fungi

Common name: Viruses (limited spectrum virucidal activity for PT2)

Field(s) of use

indoor use

Ready to use wipe for clean hard non-porous surfaces in institutional (e.g. educational institutions) and public areas. Ready to use wipe for clean hard non-porous surfaces in kitchens and the food and beverage industry. Not for domestic use

Application method(s)

Method: wiping

Detailed description:

Ready to use wipe for clean hard non-porous surfaces.

Application rate(s) and frequency

Application Rate: For wipes with size 133 × 200 mm: use 1 wipe per m2.

For wipes with size 200 × 195 mm: use 1 wipe per 1,75 m2.

No dilution required

Number and timing of application:

Use up to 5 times per day.

Use at room temperature.

Category(ies) of users

general public (non-professional)

Pack sizes and packaging material

Rigid container (snap top cap with/without Aluminium induction seal or PET induction seal) (PP): 150, 200, 500, 1 000 wipes

4.3.1.   Use-specific instructions for use

Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Open the lid, take a single wipe, close the lid. Only use wet wipes. Wipe the surface and allow to take effect for the appropriate contact time (see contact times below). Make sure to wet the surface completely. Let air dry. No rinsing.

Contact times

Pre-cleaned surface:

Bacteria and yeasts: 30 seconds

Fungi and viruses (limited spectrum virucidal activity): 5 minutes

Comply with the instructions for use. (N-359)

4.3.2.   Use-specific risk mitigation measures

Do not touch treated surfaces until completely dry.

Avoid contact with eyes. (N-317)

Only to be used by adults. (N-327)

The product information (i.e. label and/or leaflet) shall clearly show that: the product shall not be supplied to the general public (e.g. ‘for professionals only’).

Keep out of reach of children and non-target animals/pets. (N-316)

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

If medical advice is needed, have product container or label at hand. (N-360)

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

Not applicable

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

Not applicable

4.4.   Use description

Table 4

Use # 4 – Small scale disinfection - Wipes - PT 4 - Professional use

Product type

PT04: Food and feed area

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Common name: Fungi

Common name: Viruses

Field(s) of use

indoor use

Ready to use wipe.

Application method(s)

Method: wiping

Detailed description:

Ready to use wipe for clean hard non-porous surfaces in kitchens and the food and beverage industry.

Application rate(s) and frequency

Application Rate: For wipes with size 133 × 200 mm: use 1 wipe per m2; For wipes with size 200 × 195 mm: use 1 wipe per 1,75 m2; For wipes with size 200 × 390 mm: use 1 wipe per 2,5 m2 No dilution required

Number and timing of application:

Use up to 20 times per day.

Use at room temperature.

Category(ies) of users

industrial

professional

Pack sizes and packaging material

Rigid container (snap top cap with/without Aluminium induction seal or PET induction seal) (PP): 150, 200, 500, 1 000 wipes

4.4.1.   Use-specific instructions for use

Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Open the lid, take a single wipe, close the lid. Only use wet wipes. Wipe the surface and allow to take effect for the appropriate contact time (see contact times below). Make sure to wet the surface completely. Let it air dry. No rinsing.

Contact times

Pre-cleaned surface in food and beverage industry at room temperature:

Bacteria and yeasts: 30 seconds

Fungi and viruses: 5 minutes

4.4.2.   Use-specific risk mitigation measures

Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).

Unprotected persons shall be kept away from treated areas until surfaces are dry. (N-188)

The use of these protective equipments is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full references to this act and the European Standards.

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

Not applicable

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

Not applicable

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

Not applicable

4.5.   Use description

Table 5

Use # 5 – Glove disinfection - PT 2 & PT 4 - Professional use

Product type

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

PT04: Food and feed area

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Common name: Bacteria

Common name: Yeasts

Field(s) of use

indoor use

Ready to use wipe

Application method(s)

Method: wiping

Detailed description:

Ready to use wipe on clean non-porous gloves worn by professional workers in hospitals and other healthcare institutions, laboratories and the pharmaceutical, cosmetic, dairy, beverage and processed food industries.

Application rate(s) and frequency

Application Rate: 1 wipe (both hands) No dilution required

Number and timing of application:

Use up to 10 times per day.

Use at room temperature

Category(ies) of users

industrial

professional

Pack sizes and packaging material

Rigid container (snap top cap with/without Aluminium induction seal or PET induction seal) (PP): 150, 200, 500, 1 000 wipes

4.5.1.   Use-specific instructions for use

Use only on clean non-porous gloves. Open the lid, take a single wipe, close the lid. Only use wet wipes. Wipe the gloves and allow to take effect for 30 seconds for bacteria and yeasts. Let it air dry. Make sure to wet the surface completely. No rinsing.

Do not use for disinfection of medical gloves falling under Regulation (EU) 2017/745

4.5.2.   Use-specific risk mitigation measures

The use of eye protection is mandatory (chemical goggles according to EN 166 or equivalent). (N-70)

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

Not applicable

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

Not applicable

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

Not applicable

5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1.   Instructions for use

See use specific instructions in the individual use.

5.2.   Risk mitigation measures

See specific risk mitigation measures in the individual use.

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. Call a POISON CENTRE or a doctor.

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

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

Stability and Reactivity

Reactivity: No reactivity hazards known under normal storage and use conditions.

Chemical stability: Stable under normal storage and use conditions.

Possibility of hazardous reactions: No hazardous reactions known under normal storage and use conditions.

Conditions to avoid: Take action to prevent static discharges.

Incompatible materials: None known under normal use conditions.

Hazardous decomposition products: None known under normal storage and use conditions.

Environmental precautions

The product shall not reach sewage water or drainage ditch undiluted or unneutralised.

Do not allow to enter drainage system, surface or groundwater. Dilute with plenty of water.

Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, universal binders, sawdust).

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

Dispose according to national or local regulations.

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

24 months shelf life. Store below 30 °C.

6.   OTHER INFORMATION

The full titles of the EN standards referenced in sections ‘Use-specific risk mitigation measures’ are:

EN 374 – Protective gloves against dangerous chemicals and micro-organisms

EN 166 – Personal Eye Protection – Specifications

Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1–175).

With respect to the ‘Category (ies) of users’ note: ‘Professionals (including industrial users)’ means trained professionals if this is required by national legislation.

For packaging containing:

500 - 1 000 wipes per container:

Wipe material: 100 % Polypropylene or 60 % Viscose/40 % Polypropylene

Wipe area/ pack: 39 m2

Approximate volume of liquid/ wipe: 2,69 g/wipe (1 000 pc); 5,48 g/wipe (500 pc)

150 - 200 wipes per container:

Wipe material: 100 % Polypropylene or 60 % Viscose/40 % Polypropylene

Wipe area/ pack: 4 m2 (150 pc); 5,3 m2 (200 pc)

Approximate volume of liquid/ wipe: 2,27 g/wipe

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)

Divodes FG Wipes VT75

Market area: EU

Divodes FG Wipes

Market area: EU

Suma Disinfection Wipes

Market area: EU

Suma Disinfection Wipes XL

Market area: EU

Suma Disinfection Wipes XXL

Market area: EU

Suma Quicksan Wipes

Market area: EU

Suma Quicksan Wipes XL

Market area: EU

Suma Quicksan Wipes XXL

Market area: EU

DOMESTOS QuickGuard Wipes

Market area: EU

GLORIX QuickGuard Wipes

Market area: EU

KLINEX QuickGuard Wipes

Market area: EU

LYSOFORM QuickGuard Wipes

Market area: EU

SAVO QuickGuard Wipes

Market area: EU

CIF QuickGuard Wipes

Market area: EU

VISS QuickGuard Wipes

Market area: EU

JIF QuickGuard Wipes

Market area: EU

FLORASZEPT QuickGuard Wipes

Market area: EU

ANDY QuickGuard Wipes

Market area: EU

SUPERANDY QuickGuard Wipes

Market area: EU

ANDYSAN QuickGuard Wipes

Market area: EU

Authorisation number

 

EU-0034601-0002 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-1-ol

 

Active substance

71-23-8

200-746-9

52,2 % (w/w)

Propan-2-ol

 

Active substance

67-63-0

200-661-7

17,5 % (w/w)


ELI: http://data.europa.eu/eli/reg_impl/2026/287/oj

ISSN 1977-0677 (electronic edition)


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