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Document 32026R0158
Commission Implementing Regulation (EU) 2026/158 of 23 January 2026 granting a Union authorisation for the biocidal product family Hydrogen peroxide product family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2026/158 of 23 January 2026 granting a Union authorisation for the biocidal product family Hydrogen peroxide product family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Commission Implementing Regulation (EU) 2026/158 of 23 January 2026 granting a Union authorisation for the biocidal product family Hydrogen peroxide product family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
C/2026/347
OJ L, 2026/158, 26.1.2026, ELI: http://data.europa.eu/eli/reg_impl/2026/158/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)
In force
|
Official Journal |
EN L series |
|
2026/158 |
26.1.2026 |
COMMISSION IMPLEMENTING REGULATION (EU) 2026/158
of 23 January 2026
granting a Union authorisation for the biocidal product family ‘Hydrogen peroxide product 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 19 January 2017, Arche Consortia 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 ‘Hydrogen peroxide product 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-FN029041-50 in the Register for Biocidal Products. |
|
(2) |
‘Hydrogen peroxide product family’ contains hydrogen peroxide as the active substance, 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 8 March 2023, 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 20 June 2023, the ECHA Efficacy Working Group (WG-II-2023) discussed the application for Union authorisation of the biocidal product family ‘Hydrogen peroxide product family’ and concluded that the hydrogen peroxide concentration of products in use #2 of meta SPC 5 (summary of the biocidal product characteristics) would have to be raised from 0,5 % H2O2 to 5 % H2O2 to ensure their efficacy against fungi. |
|
(5) |
On 5 October 2023, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Hydrogen peroxide product family’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012. However, the opinion of the Agency, including the draft SPC, omitted to take into account the increase of the concentration to 5 % H2O2 for the risk to human health. |
|
(6) |
On 23 October 2023, 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, after discussion in the Standing Committee on Biocidal Products on 21 June 2024 (3), requested the Agency to provide a revised opinion, including a revised draft SPC, identifying adequate use conditions for products in use #2 of meta SPC 5 in accordance with Article 75(1), point (g), of Regulation (EU) No 528/2012 taking into account the concentration of 5 % H2O2 of products in use #2 of meta SPC 5. |
|
(8) |
On 28 May 2025, the Agency transmitted to the Commission its revised opinion (4), including a revised draft SPC, as well as an updated assessment report, including a new assessment of the risks for products containing 5 % H2O2 for use #2 against fungi in meta SPC 5 and a recommendation for adequate risk mitigations measures. The revised draft SPC also included a better and consistent description of the uses #1, #2 and #3 of meta SPC 5.The revised opinion concludes that ‘Hydrogen peroxide product 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. |
|
(9) |
The Commission concurs with the revised Agency opinion and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘Hydrogen peroxide product family’. |
|
(10) |
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-0031657-0000 is hereby granted to Arche Consortia for the making available on the market and use of the biocidal product family ‘Hydrogen peroxide product family’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 15 February 2026 until 31 January 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, 23 January 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) ECHA opinion of 13 September 2023 on the Union authorisation of ‘Hydrogen peroxide product family’ (ECHA/BPC/392/2023), https://echa.europa.eu/opinions-on-union-authorisation.
(3) 84th meeting of the Standing Committee on Biocidal Products of 21 June 2024.
(4) ECHA opinion of 16 May 2025 on the Union authorisation of ‘Hydrogen peroxide product family’ (ECHA/BPC/482/2025), https://echa.europa.eu/opinions-on-union-authorisation.
ANNEX
Summary of product characteristics for a biocidal product family
Hydrogen peroxide product 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-0031657-0000
R4BP asset number: EU-0031657-0000
PART I
FIRST INFORMATION LEVEL
1. ADMINISTRATIVE INFORMATION
1.1. Family name
|
Name |
Hydrogen peroxide product 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 |
ARCHE Consortia |
|
Address |
Liefkensstraat 35D 9032 Wondelgem Belgium |
|
|
Authorisation number |
|
EU-0031657-0000 |
|
R4BP asset number |
|
EU-0031657-0000 |
|
Date of the authorisation |
|
15 February 2026 |
|
Expiry date of the authorisation |
|
31 January 2036 |
1.4. Manufacturer(s) of the product
|
Name of manufacturer |
Messing & Keppler Abfülldienst GmbH |
|
Address of manufacturer |
Im Hengstfeld 47 32657 Lemgo Germany |
|
Location of manufacturing sites |
Messing & Keppler Abfülldienst GmbH site 1 Im Hengstfeld 47 32657 Lemgo Germany |
|
Name of manufacturer |
Grundmann Service GmbH |
|
Address of manufacturer |
In der Feige 116 45699 Herten Germany |
|
Location of manufacturing sites |
Grundmann Service GmbH site 1 Ruhrorter Str. 108-110 45478 Mülheim a.d.Ruhr Germany |
|
Name of manufacturer |
Baufan Bauchemie Leipzig GmbH |
|
Address of manufacturer |
Ludwig-Hupfeld-Str. 19 04178 Leipzig Germany |
|
Location of manufacturing sites |
Baufan Bauchemie Leipzig GmbH site 1 Ludwig-Hupfeld-Str. 19 04178 Leipzig Germany |
|
Name of manufacturer |
Wepos Chemie GmbH |
|
Address of manufacturer |
Textilstr. 2 41751 Viersen Germany |
|
Location of manufacturing sites |
Wepos Chemie GmbH site 1 Textilstr. 2 41751 Viersen Germany |
|
Name of manufacturer |
MELLERUD CHEMIE GMBH |
|
Address of manufacturer |
Bernhard-Röttgen-Waldweg 20 41379 Brüggen Germany |
|
Location of manufacturing sites |
MELLERUD CHEMIE GMBH site 1 Bernhard-Röttgen-Waldweg 20 41379 Brüggen Germany |
|
Name of manufacturer |
MPD plus, s.r.o. |
|
Address of manufacturer |
Nábřeží Dr. Beneše 2307 269 01 Rakovník Czechia |
|
Location of manufacturing sites |
MPD plus, s.r.o. site 1 Nábřeží Dr. Beneše 2307 269 01 Rakovník Czechia |
|
Name of manufacturer |
E’COSì s.r.l. |
|
Address of manufacturer |
Via G.Giorgi 12. 47122 Forlì Italy |
|
Location of manufacturing sites |
E’COSì s.r.l. site 1 Via G.Giorgi 12. 47122 Forlì Italy |
1.5. Manufacturer(s) of the active substance(s)
|
Active substance |
Hydrogen peroxide |
|
Name of manufacturer |
Evonik Antwerpen NV |
|
Address of manufacturer |
Tijsmanstunnel West 2040 Antwerpen Belgium |
|
Location of manufacturing sites |
Evonik Antwerpen NV site 1 Tijsmanstunnel West 2040 Antwerpen Belgium |
|
Active substance |
Hydrogen peroxide |
|
Name of manufacturer |
Evonik Resource Efficiency GmbH |
|
Address of manufacturer |
Rellinghauser Straße 1-11 45128 Essen Germany |
|
Location of manufacturing sites |
Evonik Resource Efficiency GmbH site 1 Untere Kanalstr. 3 79618 Rheinfelden Germany |
|
Active substance |
Hydrogen peroxide |
|
Name of manufacturer |
Evonik Peroxid GmbH |
|
Address of manufacturer |
Industriestraße 1 9721 Weißenstein Austria |
|
Location of manufacturing sites |
Evonik Peroxid GmbH site 1 Industriestraße 1 9721 Weißenstein Austria |
|
Active substance |
Hydrogen peroxide |
|
Name of manufacturer |
Evonik Peroxide Netherlands BV |
|
Address of manufacturer |
Hettenheuvelweg 37 /39 1101 BM Amsterdam Netherlands (the) |
|
Location of manufacturing sites |
Evonik Peroxide Netherlands BV site 1 Oosterhorn 14 9936 HD Farmsum Netherlands (the) |
|
Active substance |
Hydrogen peroxide |
||
|
Name of manufacturer |
Arkema France |
||
|
Address of manufacturer |
420 rue d’Estienne d'Orves 92705 Colombes Cedex France |
||
|
Location of manufacturing sites |
|
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 (%) |
|
Hydrogen peroxide |
|
Active substance |
7722-84-1 |
231-765-0 |
6,04 - 49,5 % (w/w) |
|
Sulphuric acid |
Sulphuric acid |
Non-active substance |
7664-93-9 |
|
0 - 0,44 % (w/w) |
|
Isotridecanol ethoxylated |
Isotridecanol ethoxylated |
Non-active substance |
|
500-027-2 |
0 - 2,88 % (w/w) |
|
D-Glucopyranose, oligomers, decyl octyl glycosides |
D-Glucopyranose, oligomers, decyl octyl glycosides |
Non-active substance |
68515-73-1 |
|
0 - 2,5 % (w/w) |
|
- |
Alcohols, C12-14, ethoxylated, sulfates, sodium salts |
Non-active substance |
68891-38-3 |
500-234-8 |
0 - 0,28 % (w/w) |
|
- |
Sodium etasulfate |
Non-active substance |
126-92-1 |
204-812-8 |
0 - 0,9 % (w/w) |
2.2. Type(s) of formulation
|
Formulation type(s) |
AL Any other liquid SL Soluble concentrate |
PART II
SECOND INFORMATION LEVEL META SPC(S)
1. META SPC 1 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 1 identifier
|
Identifier |
Meta SPC: Meta SPC 1 |
1.2. Suffix to the authorisation number
|
Number |
1-1 |
1.3. Product type(s)
|
Product type(s) |
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 (%) |
|
Hydrogen peroxide |
|
Active substance |
7722-84-1 |
231-765-0 |
6,04 - 7,9 % (w/w) |
|
Sulphuric acid |
Sulphuric acid |
Non-active substance |
7664-93-9 |
|
0,264 - 0,44 % (w/w) |
|
Isotridecanol ethoxylated |
Isotridecanol ethoxylated |
Non-active substance |
|
500-027-2 |
0 - 0,9 % (w/w) |
|
D-Glucopyranose, oligomers, decyl octyl glycosides |
D-Glucopyranose, oligomers, decyl octyl glycosides |
Non-active substance |
68515-73-1 |
|
0 - 0,9 % (w/w) |
|
- |
Alcohols, C12-14, ethoxylated, sulfates, sodium salts |
Non-active substance |
68891-38-3 |
500-234-8 |
0 - 0,28 % (w/w) |
|
- |
Sodium etasulfate |
Non-active substance |
126-92-1 |
204-812-8 |
0 - 0,9 % (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 |
H290: May be corrosive to metals. H318: Causes serious eye damage. |
|
Precautionary statements |
P234: Keep only in original packaging. P280: Wear eye/face protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER or doctor/physician. P390: Absorb spillage to prevent material damage. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Surface disinfection healthcare, RTU
|
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) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data |
||||
|
Field(s) of use |
indoor use Disinfection of hard non-porous surfaces in healthcare |
||||
|
Application method(s) |
Method: spraying Detailed description: Trigger foaming of ready to use (RTU) product |
||||
|
Application rate(s) and frequency |
Application Rate: 40 ml/m2 RTU Number and timing of application: Apply RTU product on surfaces;
Use frequency: up to 4 times a day Use temperature: room temperature |
||||
|
Category(ies) of users |
professional |
||||
|
Pack sizes and packaging material |
500 ml and 750 ml trigger foam High Density Polyethene (HDPE) 5 litres HDPE bottle (refill for trigger foam) |
4.1.1. Use-specific instructions for use
Spray evenly and make sure to wet surfaces completely.
For control of bacteria, yeasts and fungi: Allow to take effect for 5 minutes.
For control of bacteria, yeasts, fungi and viruses: Allow to take effect for 15 minutes.
Rinse surfaces after use.
4.1.2. Use-specific risk mitigation measures
see general directions of use for meta-SPC 1
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 of use for meta-SPC 1
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions of use for meta-SPC 1
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
see general directions of use for meta-SPC 1
4.2. Use description
Table 2
Surface disinfection non-healthcare and food/feed areas, RTU
|
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) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data |
|
Field(s) of use |
indoor use Disinfection of hard non-porous surfaces in non-healthcare and food and/or feed areas |
|
Application method(s) |
Method: spraying Detailed description: Trigger foaming of ready to use (RTU) product |
|
Application rate(s) and frequency |
Application Rate: 40 ml/m2 RTU Number and timing of application: Apply undiluted product. Use temperature: room temperature Contact time: bacteria, yeasts, fungi; 5 minutes viruses; 15 minutes Use frequency: up to 10 times a day |
|
Category(ies) of users |
professional |
|
Pack sizes and packaging material |
500 ml and 750 ml trigger foam High Density Polyethene (HDPE), 5 litres bottle HDPE (refill for trigger foam) |
4.2.1. Use-specific instructions for use
Spray evenly and make sure to wet surfaces completely.
For control of bacteria, yeasts and fungi: Allow to take effect for 5 minutes.
For control of viruses: Allow to take effect for 15 minutes.
Rinse surfaces after use.
4.2.2. Use-specific risk mitigation measures
see general directions of use for meta-SPC 1
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 of use for meta-SPC 1
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions of use for meta-SPC 1
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 of use for meta-SPC 1
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 1
5.1. Instructions for use
see use-specific instructions for each use
5.2. Risk mitigation measures
Keep out of reach of children.
Re-entry is only permitted once the air concentration has dropped below 0,9 ppm (1,25 mg/m3) or relevant lower national reference value. Use a calibrated sensor to confirm the enclosure is below 0,9 ppm (1,25 mg/m3) or the corresponding national reference value prior to re-entry.
No access of third parties during application/treatment.
Do not use for cleaning toilets or in a cleaning toilets routine.
Professional user:
|
— |
During loading: Wear protective gloves classified under EN 374 or equivalent and goggles consistent with EN ISO 16321 or equivalent. Wash hands after use. |
|
— |
During application: Wear a respiratory protective equipment (RPE) aerosol and gas filter consistent with EN 14387 or equivalent with an assigned protection factor of at least 20 (filter type (code letter, colour) to be specified by the authorisation holder within the product information). Wear protective gloves against chemicals classified under EN 374 or equivalent and protective goggles consistent with EN ISO16321 or equivalent. |
The full references to the EN standards are available in Section 6.
This 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 reference to this act.
Wash hands after use. Always spray away from user. Only for treatment of small surfaces (2 m2)
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid measures:
|
|
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112 or ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. |
|
|
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or ambulance for medical assistance. |
|
|
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. |
|
|
IF 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 or ambulance for medical assistance. |
Environmental precautions:
|
|
Do not allow product to reach sewage system or water bodies. |
|
|
Dilute spillages with much water. |
5.4. Instructions for safe disposal of the product and its packaging
Dispose of this material and its container to hazardous or special waste collection point. Must not be disposed together with household garbage. Do not allow product to reach sewage system. Disposal should be in accordance with local authority regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Store in dry, dark and well-ventilated area. Protect from frost. Store below 30 °C. Protect from direct sunlight. Keep container tightly closed. Must only be kept in original packaging. Shelf life is 36 months.
6. OTHER INFORMATION
Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full titles of the EN standards referenced in section 5.2 ‘Risk mitigation measures’ are:
EN 374 - Protective gloves against dangerous chemicals and micro-organisms
EN ISO 16321 – Eye and face protection for occupational use
EN 14387 - Respiratory Protective Devices – Gas filter
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).
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) |
HP-BPF-12 |
Market area: EU |
|||||
|
Authorisation number |
|
EU-0031657-0001 1-1 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Hydrogen peroxide |
|
Active substance |
7722-84-1 |
231-765-0 |
7,9 % (w/w) |
||
|
Sulphuric acid |
Sulphuric acid |
Non-active substance |
7664-93-9 |
|
0,33 % (w/w) |
||
|
Isotridecanol ethoxylated |
Isotridecanol ethoxylated |
Non-active substance |
|
500-027-2 |
0,9 % (w/w) |
||
7.2. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
HP-BPF-14 |
Market area: EU |
|||||
|
Authorisation number |
|
EU-0031657-0002 1-1 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Hydrogen peroxide |
|
Active substance |
7722-84-1 |
231-765-0 |
7,9 % (w/w) |
||
|
Sulphuric acid |
Sulphuric acid |
Non-active substance |
7664-93-9 |
|
0,44 % (w/w) |
||
|
D-Glucopyranose, oligomers, decyl octyl glycosides |
D-Glucopyranose, oligomers, decyl octyl glycosides |
Non-active substance |
68515-73-1 |
|
0,9 % (w/w) |
||
7.3. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
HP-BPF-07 |
Market area: EU |
|||||
|
Authorisation number |
|
EU-0031657-0003 1-1 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Hydrogen peroxide |
|
Active substance |
7722-84-1 |
231-765-0 |
7,9 % (w/w) |
||
|
Sulphuric acid |
Sulphuric acid |
Non-active substance |
7664-93-9 |
|
0,33 % (w/w) |
||
|
- |
Sodium etasulfate |
Non-active substance |
126-92-1 |
204-812-8 |
0,9 % (w/w) |
||
7.4. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
HP-BPF-03 |
Market area: EU |
|||||
|
Authorisation number |
|
EU-0031657-0004 1-1 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Hydrogen peroxide |
|
Active substance |
7722-84-1 |
231-765-0 |
6,4 % (w/w) |
||
|
Sulphuric acid |
Sulphuric acid |
Non-active substance |
7664-93-9 |
|
0,264 % (w/w) |
||
|
- |
Sodium etasulfate |
Non-active substance |
126-92-1 |
204-812-8 |
0,9 % (w/w) |
||
7.5. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
HP-BPF-08 |
Market area: EU |
|||||
|
Authorisation number |
|
EU-0031657-0005 1-1 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Hydrogen peroxide |
|
Active substance |
7722-84-1 |
231-765-0 |
6,04 % (w/w) |
||
|
Sulphuric acid |
Sulphuric acid |
Non-active substance |
7664-93-9 |
|
0,33 % (w/w) |
||
|
D-Glucopyranose, oligomers, decyl octyl glycosides |
D-Glucopyranose, oligomers, decyl octyl glycosides |
Non-active substance |
68515-73-1 |
|
0,25 % (w/w) |
||
|
- |
Alcohols, C12-14, ethoxylated, sulfates, sodium salts |
Non-active substance |
68891-38-3 |
500-234-8 |
0,28 % (w/w) |
||
1. META SPC 2 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 2 identifier
|
Identifier |
Meta SPC: Meta SPC 2 |
1.2. Suffix to the authorisation number
|
Number |
1-2 |
1.3. Product type(s)
|
Product type(s) |
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 (%) |
|
Hydrogen peroxide |
|
Active substance |
7722-84-1 |
231-765-0 |
9,9 - 9,9 % (w/w) |
|
Sulphuric acid |
Sulphuric acid |
Non-active substance |
7664-93-9 |
|
0,33 - 0,44 % (w/w) |
|
Isotridecanol ethoxylated |
Isotridecanol ethoxylated |
Non-active substance |
|
500-027-2 |
0 - 2,88 % (w/w) |
|
D-Glucopyranose, oligomers, decyl octyl glycosides |
D-Glucopyranose, oligomers, decyl octyl glycosides |
Non-active substance |
68515-73-1 |
|
0 - 2,5 % (w/w) |
|
- |
Alcohols, C12-14, ethoxylated, sulfates, sodium salts |
Non-active substance |
68891-38-3 |
500-234-8 |
0 - 0,28 % (w/w) |
|
- |
Sodium etasulfate |
Non-active substance |
126-92-1 |
204-812-8 |
0 - 0,9 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 2
|
Formulation type(s) |
AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2
|
Hazard statements |
H318: Causes serious eye damage. H272: May intensify fire; oxidiser. EUH208: Contains d-limonene. May produce an allergic reaction. |
|
Precautionary statements |
P280: Wear eye/face protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER or doctor/physician. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P370+P378: In case of fire: Use water to extinguish. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Surface disinfection healthcare, RTU
|
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) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data |
||||
|
Field(s) of use |
indoor use Disinfection of hard non-porous surfaces in healthcare. |
||||
|
Application method(s) |
Method: spraying Detailed description: Trigger foaming of ready to use (RTU) product |
||||
|
Application rate(s) and frequency |
Application Rate: 40 ml/m2 RTU Number and timing of application: Apply RTU product on:
Use frequency: up to 4 times a day Use temperature: room temperature |
||||
|
Category(ies) of users |
professional |
||||
|
Pack sizes and packaging material |
500 ml and 750 ml High Density Polyethene (HDPE) trigger foam HDPE |
4.1.1. Use-specific instructions for use
Spray evenly and make sure to wet surfaces completely.
For control of bacteria, yeasts and fungi: Allow to take effect for 5 mins.
For control of bacteria, yeasts, fungi and viruses: Allow to take effect for 15 mins.
Rinse surfaces after use.
4.1.2. Use-specific risk mitigation measures
see general directions for use of meta-SPC 2
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 of meta-SPC 2
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use of meta-SPC 2
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
see general directions for use of meta-SPC 2
4.2. Use description
Table 2
Surface disinfection non-healthcare and food/feed areas, RTU
|
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) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data |
|
Field(s) of use |
indoor use Disinfection of hard non-porous surfaces in non-healthcare and food and/or feed areas |
|
Application method(s) |
Method: spraying Detailed description: Trigger foaming of ready to use (RTU) product |
|
Application rate(s) and frequency |
Application Rate: 40 ml/m2 RTU Number and timing of application: Apply RTU product. Use temperature: room temperature Contact time: bacteria, yeasts, fungi: 5 minutes viruses: 15 minutes Use frequency: up to 10 times a day |
|
Category(ies) of users |
professional |
|
Pack sizes and packaging material |
500 ml and 750 ml trigger foam High Density Polyethene (HDPE) |
4.2.1. Use-specific instructions for use
Spray evenly and make sure to wet surfaces completely.
For control of bacteria, yeasts and fungi: Allow to take effect for 5 mins.
For control of viruses: Allow to take effect for 15 mins.
Rinse surfaces after use.
4.2.2. Use-specific risk mitigation measures
see general directions for use of meta-SPC 2
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 of meta-SPC 2
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use of meta-SPC 2
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
see general directions for use of meta-SPC 2
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 2
5.1. Instructions for use
see use-specific instructions for each use
5.2. Risk mitigation measures
Keep out of reach of children.
Re-entry is only permitted once the air concentration has dropped below 0,9 ppm (1,25 mg/m3) or relevant lower national reference value.
Use a calibrated sensor to confirm the enclosure is below 0,9 ppm (1,25 mg/m3) or the corresponding national reference value prior to re-entry.
Unprotected persons are not allowed to be present during the application of the product. No access of third parties during application/treatment.
Do not use for cleaning toilets or in a cleaning toilets routine.
During application and re-entry in case of emergency: Wear a respiratory protective equipment (RPE) aerosol and gas filter consistent with EN 14387 or equivalent with an assigned protection factor of at least 40 (filter type (code letter, colour) to be specified by the authorisation holder within the product information).
During application: Wear protective gloves classified under EN 374 or equivalent and goggles consistent with EN ISO 16321 or equivalent.
The full references to the EN standards are available in Section 6.
This 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 reference to this act
Wash hands after use.
Always spray away from the user. Only for treatment of small surfaces (2 m2).
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid measures:
|
|
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112 or ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. |
|
|
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or ambulance for medical assistance. |
|
|
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. |
|
|
IF 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 or ambulance for medical assistance. |
Environmental precautions:
|
|
Do not allow product to reach sewage system or water bodies. |
|
|
Dilute spillages with much water. |
5.4. Instructions for safe disposal of the product and its packaging
Dispose of this material and its container to hazardous or special waste collection point. Must not be disposed together with household garbage. Do not allow product to reach sewage system. Disposal should be in accordance with local authority regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Store in dry, dark and well-ventilated area. Protect from frost. Store below 30 °C. Protect from direct sunlight. Keep container tightly closed. Must only be kept in original packaging. Shelf life is 36 months.
6. OTHER INFORMATION
Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full titles of the EN standards referenced in section 5.2 ‘Risk mitigation measures’ are:
|
|
EN 374 - Protective gloves against dangerous chemicals and micro-organisms |
|
|
EN ISO 16321 – Eye and face protection for occupational use |
|
|
EN 14387 - Respiratory Protective Devices – Gas filter |
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).
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) |
HP-BPF-01 |
Market area: EU |
|||||
|
Authorisation number |
|
EU-0031657-0006 1-2 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Hydrogen peroxide |
|
Active substance |
7722-84-1 |
231-765-0 |
9,9 % (w/w) |
||
|
Sulphuric acid |
Sulphuric acid |
Non-active substance |
7664-93-9 |
|
0,33 % (w/w) |
||
|
Isotridecanol ethoxylated |
Isotridecanol ethoxylated |
Non-active substance |
|
500-027-2 |
2,88 % (w/w) |
||
7.2. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
HP-BPF-06 |
Market area: EU |
|||||
|
Authorisation number |
|
EU-0031657-0007 1-2 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Hydrogen peroxide |
|
Active substance |
7722-84-1 |
231-765-0 |
9,9 % (w/w) |
||
|
Sulphuric acid |
Sulphuric acid |
Non-active substance |
7664-93-9 |
|
0,44 % (w/w) |
||
|
D-Glucopyranose, oligomers, decyl octyl glycosides |
D-Glucopyranose, oligomers, decyl octyl glycosides |
Non-active substance |
68515-73-1 |
|
2,5 % (w/w) |
||
1. META SPC 3 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 3 identifier
|
Identifier |
Meta SPC: Meta SPC 3 |
1.2. Suffix to the authorisation number
|
Number |
1-3 |
1.3. Product type(s)
|
Product type(s) |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals PT04: Food and feed area |
2. META SPC 3 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 3
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Hydrogen peroxide |
|
Active substance |
7722-84-1 |
231-765-0 |
10 - 10 % (w/w) |
|
- |
Alcohols, C12-14, ethoxylated, sulfates, sodium salts |
Non-active substance |
68891-38-3 |
500-234-8 |
0 - 0,28 % (w/w) |
|
- |
Sodium etasulfate |
Non-active substance |
126-92-1 |
204-812-8 |
0 - 0,9 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 3
|
Formulation type(s) |
AL Any other liquid |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3
|
Hazard statements |
H318: Causes serious eye damage. H290: May be corrosive to metals. H272: May intensify fire; oxidiser. |
|
Precautionary statements |
P280: Wear eye/face protection. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER or doctor/physician. P234: Keep only in original packaging. P390: Absorb spillage to prevent material damage. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P370+P378: In case of fire: Use water to extinguish. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Surface disinfection healthcare, RTU
|
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) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data |
||||
|
Field(s) of use |
indoor use Disinfection of hard non-porous surfaces in healthcare. |
||||
|
Application method(s) |
Method: spraying Detailed description: Trigger foaming of ready to use (RTU) product |
||||
|
Application rate(s) and frequency |
Application Rate: 40 ml/m2 RTU Number and timing of application: Apply RTU product on surfaces:
Use frequency: up to 4 times a day Use temperature: room temperature |
||||
|
Category(ies) of users |
professional |
||||
|
Pack sizes and packaging material |
750 ml, 1 litres trigger foam High Density Polyethene (HDPE) 5 litres, 10 litres, 20 litres and 50 litres bottle HDPE (refill for trigger foam) |
4.1.1. Use-specific instructions for use
Spray evenly and make sure to wet surfaces completely.
For control of bacteria, yeasts, and fungi: Allow to take effect for 5 mins.
For control of bacteria, yeasts, fungi and viruses: Allow to take effect for 15 mins.
Rinse surfaces after use.
4.1.2. Use-specific risk mitigation measures
see general directions for use of meta-SPC 3
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
see general directions for use of meta-SPC 3
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use of meta-SPC 3
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
see general directions for use of meta-SPC 3
4.2. Use description
Table 2
Surface disinfection non-healthcare and food/feed ares, RTU
|
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) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data |
|
Field(s) of use |
indoor use Disinfection of hard non-porous surfaces in non-healthcare and food and/or feed areas |
|
Application method(s) |
Method: spraying Detailed description: Trigger foaming of ready to use (RTU) product |
|
Application rate(s) and frequency |
Application Rate: 40 ml/m2 RTU Number and timing of application: Apply RTU product. Use temperature: room temperature Contact time: bacteria, yeasts and fungi: 5 minutes viruses: 15 minutes Use frequency: up to 10 times a day |
|
Category(ies) of users |
professional |
|
Pack sizes and packaging material |
750 ml, 1 litres trigger foam High Density Polyethene (HDPE) 5 litres, 10 litres, 20 litres and 50 litres bottle HDPE (refill for trigger foam) |
4.2.1. Use-specific instructions for use
Spray evenly and make sure to wet surfaces completely.
For control of bacteria, yeasts and fungi: Allow to take effect for 5 minutes.
For control of viruses: Allow to take effect for 15 minutes.
Rinse surfaces after use.
4.2.2. Use-specific risk mitigation measures
see general directions for use of meta-SPC 3
4.2.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
see general directions for use of meta-SPC 3
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use of meta-SPC 3
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
see general directions for use of meta-SPC 3
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
5.1. Instructions for use
see use-specific instructions for each use
5.2. Risk mitigation measures
Keep out of reach of children. Re-entry is only permitted once the air concentration has dropped below 0,9 ppm (1,25 mg/m3) or relevant lower national reference value. Use a calibrated sensor to confirm the enclosure is below 0,9 ppm (1,25 mg/m3) or the corresponding national reference value prior to re-entry.
Do not use for cleaning toilets or in a cleaning toilets routine.
Unprotected persons are not allowed to be present during the application of the product. No access of third parties during application/treatment
|
— |
During loading: Wear protective gloves classified under EN 374 or equivalent and goggles consistent with EN ISO16321 or equivalent. Wash hands after use. |
|
— |
During application and re-entry in case of emergency: Wear a respiratory protective equipment (RPE) aerosol and gas filter consistent with EN 14387 or equivalent with an assigned protection factor of at least 40 (filter type (code letter, colour) to be specified by the authorisation holder within the product information). |
|
— |
During application: Wear protective gloves classified under EN 374 or equivalent and goggles consistent with EN ISO 16321 or equivalent. |
The full references to the EN standards are available in Section 6.
This 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 reference to this act.
Wash hands after use.
Always spray away from user. Only for treatment of small surfaces (2 m2).
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid measures:
|
|
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112 or ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. |
|
|
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or ambulance for medical assistance. |
|
|
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. |
|
|
IF 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 or ambulance for medical assistance. |
Environmental precautions:
|
|
Do not allow product to reach sewage system or water bodies. |
|
|
Dilute spillages with much water. |
5.4. Instructions for safe disposal of the product and its packaging
Dispose of this material and its container to hazardous or special waste collection point. Must not be disposed together with household garbage. Do not allow product to reach sewage system. Disposal should be in accordance with Local Authority Regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Store in dry, dark and well-ventilated area. Protect from frost. Store below 30 °C. Protect from direct sunlight. Keep container tightly closed. Must only be kept in original packaging. Shelf life is 24 months.
6. OTHER INFORMATION
The full titles of the EN standards referenced in section 5.2 ‘Risk mitigation measures’ are:
|
|
EN 374 - Protective gloves against dangerous chemicals and micro-organisms |
|
|
EN ISO 16321 – Eye and face protection for occupational use |
|
|
EN 14387 - Respiratory Protective Devices |
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).
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) |
HP-BPF-15 |
Market area: EU |
|||||
|
Authorisation number |
|
EU-0031657-0008 1-3 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Hydrogen peroxide |
|
Active substance |
7722-84-1 |
231-765-0 |
10 % (w/w) |
||
1. META SPC 4 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 4 identifier
|
Identifier |
Meta SPC: Meta SPC 4 |
1.2. Suffix to the authorisation number
|
Number |
1-4 |
1.3. Product type(s)
|
Product type(s) |
PT02: Disinfectants and algaecides not intended for direct application to humans or animals |
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 (%) |
|
Hydrogen peroxide |
|
Active substance |
7722-84-1 |
231-765-0 |
19,95 - 19,95 % (w/w) |
|
- |
Alcohols, C12-14, ethoxylated, sulfates, sodium salts |
Non-active substance |
68891-38-3 |
500-234-8 |
0 - 0,28 % (w/w) |
|
- |
Sodium etasulfate |
Non-active substance |
126-92-1 |
204-812-8 |
0 - 0,9 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 4
|
Formulation type(s) |
SL Soluble concentrate |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4
|
Hazard statements |
H272: May intensify fire; oxidiser. H314: Causes severe skin burns and eye damage. |
|
Precautionary statements |
P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P310: Immediately call a POISON CENTER or doctor/physician. P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P310: Immediately call a POISON CENTER or doctor/physician. P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P370+P378: In case of fire: Use water to extinguish. P234: Keep only in original packaging. P280: Wear protective gloves/protective clothing/eye protection/face protection. P390: Absorb spillage to prevent material damage. P363: Wash contaminated clothing before reuse. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Laundry disinfectant in non-healthcare areas, SL
|
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) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data |
|
Field(s) of use |
indoor use Laundry disinfectant (main wash) in non-healthcare areas |
|
Application method(s) |
Method: Closed system: washing machine Detailed description: Dose (with automated dosing pump) undiluted product into the washing machine (main wash) together with the alkalinity booster P&G Professional Ariel S7 SC Alca Extra and liquid detergent P&G Professional Ariel S1 Actilift Detergent. Wash at 60°C or more. |
|
Application rate(s) and frequency |
Application Rate: Contact time: 15 minutes. Textile to liquid ratio: 5 litres per 1 kg textile Dilution (%): 2,25 ml product per liter water (corresponding to 0,45 ml H2O2 per liter water), together with 2 ml per litre liquid detergent P&G Professional Ariel S1 Actilift Detergent and 0,715 ml per litre P&G Professional Ariel S7 SC Alca Extra Number and timing of application: Dose (with automated dosing pump) undiluted product into the washing machine (main wash) together with the alkalinity booster P&G Professional Ariel S7 SC Alca Extra and liquid detergent P&G Professional Ariel S1 Actilift Detergent. Wash at 60 °C or more. Bacteria and yeasts: 2,25 ml product per liter water (corresponding to 0,45 ml H2O2 per liter water), together with 2 ml per litre liquid detergent P&G Professional Ariel S1 Actilift Detergent and 0,715 ml per litre P&G Professional Ariel S7 SC Alca Extra 15 minutes Use frequency: up to 10 times a day |
|
Category(ies) of users |
professional |
|
Pack sizes and packaging material |
10 litres, 20 litres and 60 litres High Density Polyethene (HDPE) containers |
4.1.1. Use-specific instructions for use
see general directions of use for meta-SPC 4
4.1.2. Use-specific risk mitigation measures
see general directions of use for meta-SPC 4
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 of use for meta-SPC 4
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions of use for meta-SPC 4
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
see general directions of use for meta-SPC 4
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 4
5.1. Instructions for use
For professional use only.
Dose (with automated dosing pump) pure product into the washing machine together with alkalinity booster (P&G Professional Ariel S7 SC Alca Extra) and liquid detergent (P&G Professional Ariel S1 Actilift Detergent) in the main wash. Wash at 60 °C or more.
Dosing: per liter water, add 2,25 ml product (corresponding to 0,45 ml H2O2 per liter water), 2 ml liquid detergent P&G Professional Ariel S1 Actilift Detergent and 0,715 ml P&G Professional Ariel S7 SC Alca Extra.
Contact time: 15 minutes
Textile to liquid ratio: 5 L per 1 kg textile
5.2. Risk mitigation measures
Keep out of reach of children.
During loading of the product in the automated dosing pump: Wear protective gloves classified under EN 374 or equivalent and goggles consistent with EN ISO 16321 or equivalent.
The full references to the EN standards are available in Section 6.
This 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 reference to this act.
Wash hands after use.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid measures:
|
|
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112 or ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. |
|
|
IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or ambulance for medical assistance. |
|
|
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor. |
|
|
IF 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 or ambulance for medical assistance. |
Environmental precautions:
|
|
Do not allow product to reach sewage system or water bodies. |
|
|
Dilute spillages with much water. |
5.4. Instructions for safe disposal of the product and its packaging
Dispose of this material and its container to hazardous or special waste collection point. Must not be disposed together with household garbage. Do not allow product to reach sewage system. Disposal should be in accordance with Local Authority Regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Store in dry, dark and well-ventilated area. Protect from frost. Store below 30 °C. Protect from direct sunlight. Keep container tightly closed. Must only be kept in original packaging. Shelf life is 24 months.
6. OTHER INFORMATION
The full titles of the EN standards referenced in section 5.2 ‘Risk mitigation measures’ are:
|
|
EN 374 - Protective gloves against dangerous chemicals and micro-organisms |
|
|
EN ISO 16321 – Eye and face protection for occupational use |
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).
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
7.1. Trade name(s), authorisation number and specific composition of each individual product
|
Trade name(s) |
HP-BPF-09 |
Market area: EU |
|||||
|
Authorisation number |
|
EU-0031657-0009 1-4 |
|||||
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
||
|
Hydrogen peroxide |
|
Active substance |
7722-84-1 |
231-765-0 |
19,95 % (w/w) |
||
1. META SPC 5 ADMINISTRATIVE INFORMATION
1.1. Meta SPC 5 identifier
|
Identifier |
Meta SPC: Meta SPC 5 |
1.2. Suffix to the authorisation number
|
Number |
1-5 |
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 5 COMPOSITION
2.1. Qualitative and quantitative information on the composition of the meta SPC 5
|
Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
|
Hydrogen peroxide |
|
Active substance |
7722-84-1 |
231-765-0 |
49,5 - 49,5 % (w/w) |
|
- |
Alcohols, C12-14, ethoxylated, sulfates, sodium salts |
Non-active substance |
68891-38-3 |
500-234-8 |
0 - 0,28 % (w/w) |
|
- |
Sodium etasulfate |
Non-active substance |
126-92-1 |
204-812-8 |
0 - 0,9 % (w/w) |
2.2. Type(s) of formulation of the meta SPC 5
|
Formulation type(s) |
SL Soluble concentrate |
3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5
|
Hazard statements |
H302: Harmful if swallowed. H314: Causes severe skin burns and eye damage. H412: Harmful to aquatic life with long lasting effects. H290: May be corrosive to metals. H272: May intensify fire; oxidiser. EUH071: Corrosive to the respiratory tract. |
|
Precautionary statements |
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P220: Keep away from clothing or other combustible materials. P234: Keep only in original packaging. P260: Do not breathe vapours. P264: Wash hands thoroughly after handling. P270: Do not eat, drink or smoke when using this product. P273: Avoid release to the environment. P280: Wear protective gloves/protective clothing/eye protection/face protection. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. P310: Immediately call a POISON CENTER or doctor/physician. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P310: Immediately call a POISON CENTER or doctor/physician. 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 CENTER or doctor/physician. P363: Wash contaminated clothing before reuse. P370+P378: In case of fire: Use water to extinguish. P390: Absorb spillage to prevent material damage. P405: Store locked up. P501: Dispose of contents in accordance with applicable local, national and International regulations.. P501: Dispose of container in accordance with applicable local, national and International regulations.. |
4. AUTHORISED USE(S) OF THE META SPC
4.1. Use description
Table 1
Surface disinfection healthcare, concentrate
|
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) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data |
||||
|
Field(s) of use |
indoor use Disinfection of hard non-porous surfaces in healthcare |
||||
|
Application method(s) |
Method: manual application spraying Detailed description: Trigger spraying of diluted concentrate. Manual application by wiping with wipes; manual application by mopping with mop bucket with wringer. |
||||
|
Application rate(s) and frequency |
Application Rate: 40 ml/m2 Number and timing of application: Prepare the dilution manually or use automated dosing system Apply diluted product on surfaces:
Use frequency: up to 4 times a day. Use temperature: room temperature. |
||||
|
Category(ies) of users |
professional |
||||
|
Pack sizes and packaging material |
10 litres, 20 litres, 50 litres, 200 litres and 1 000 litres High Density Polyethene (HDPE)containers |
4.1.1. Use-specific instructions for use
Prepare the required product dilution manually or use automated dosing system.
Application method:
|
— |
Spraying: Spray diluted product (trigger spray) evenly and make sure to wet surfaces completely. |
|
— |
Wiping: soak the wipe with diluted product in a bucket or spray the diluted product on the wipe. Apply diluted product by wiping evenly and make sure to wet surfaces completely. |
|
— |
Mopping: soak the mop with diluted product using a mop bucket with wringer. Apply diluted product by mopping evenly and make sure to wet surfaces completely. |
Rinse surfaces after use.
For control of bacteria, yeasts and fungi: Allow to take effect for 5 minutes.
Dilution rate:
|
|
3 % dilution of the biocidal product (corresponding to 1,5 % H2O2) for bacteria and yeasts (3 ml of product with 50 % H2O2, add up to 100 ml with water); |
|
|
10 % dilution of the biocidal product (corresponding to 5% H2O2) for fungi (10 ml of product with 50 % H2O2, add up to 100 ml with water). |
For control of bacteria, yeast, fungi and viruses: Allow to take effect for 15 minutes.
Dilution rate:
|
|
3 % dilution of the biocidal product (corresponding to 1,5% H2O2) for bacteria, yeast and viruses (3 ml of product with 50 % H2O2, add up to 100 ml with water); |
|
|
10 % dilution of the biocidal product (corresponding to 5 % H2O2) for fungi (10 ml of product with 50 % H2O2, add up to 100 ml with water). |
4.1.2. Use-specific risk mitigation measures
Unprotected persons are not allowed to be present during the application of the product. No access of third parties during application or treatment. Re-entry is only permitted once the air concentration has dropped below 0,9 ppm (1,25 mg/m3) or relevant lower national reference value.
Use a calibrated sensor to confirm the enclosure is below 0,9 ppm (1,25 mg/m3) or the corresponding national reference value prior to re-entry.
Do not use for cleaning toilets or in a cleaning toilets routine.
During trigger spraying: Wear a respiratory protective equipment (RPE) aerosol and gas filter consistent with EN 14387 or equivalent with an assigned protection factor of at least 20 (filter type (code letter, colour) to be specified by the authorisation holder within the product information) . Wear protective coverall at least type 6 classified under EN 13034 or equivalent, gloves classified under EN 374 or equivalent and goggles consistent with EN ISO 16321 or equivalent. Wash hands after use. Always spray away from user. Only for treatment of small surfaces (2 m2)
During manual application by wiping: Wear a respiratory protective equipment (RPE) aerosol and gas filter consistent with EN 14387 or equivalent with an assigned protection factor of at least 20 (filter type (code letter, colour) to be specified by the authorisation holder within the product information). Wear protective gloves classified under EN 374 or equivalent, goggles consistent with EN ISO 16321 or equivalent and coverall classified under EN 13034 or equivalent. Wash hands after use. A mop/brush with a long handle has to be used to apply the solution. Do not immerse hands in the solution. Only for treatment of small surfaces (0,5 m2)
During manual application by mopping: Wear a respiratory protective equipment (RPE) aerosol and gas filter consistent with EN 14387 or equivalent with an assigned protection factor of at least 40 (filter type (code letter, colour) to be specified by the authorisation holder within the product information). Wear protective gloves classified under EN 374 or equivalent, goggles consistent with EN ISO 16321 or equivalent and coverall classified under EN 13034 or equivalent. Wash hands after use. Only use in rooms with a minimal ventilation of 1,5/h or with a window opened. A mop/brush with a long handle has to be used to apply the solution. Do not immerse hands in the solution.
The full references to the EN standards are available in Section 6
4.1.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
see general directions for use of meta-SPC 5
4.1.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use of meta-SPC 5
4.1.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
see general directions for use of meta-SPC 5
4.2. Use description
Table 2
Surface disinfection non-healthcare and food/feed areas, concentrate
|
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) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data |
||||
|
Field(s) of use |
indoor use Disinfection of hard non-porous surfaces in non-healthcare and food/feed areas |
||||
|
Application method(s) |
Method: manual application spraying Detailed description: Trigger spraying of diluted concentrate. Manual application by wiping with wipes. Manual application by mopping with mop bucket with wringer |
||||
|
Application rate(s) and frequency |
Application Rate: 40 ml/m2 Number and timing of application: Prepare the dilution manually or use automated dosing system Apply diluted product: Contact time: Bacteria, yeasts and fungi; 5 minutes Viruses; 15 minutes Dilution rate:
Use frequency: up to 10 times a day |
||||
|
Category(ies) of users |
professional |
||||
|
Pack sizes and packaging material |
10 litres, 20 litres, 50 litres, 200 and 1 000 litres High Density Polyethene (HDPE)containers |
4.2.1. Use-specific instructions for use
Prepare the required product dilution manually or use automated dosing system.
Application method:
|
— |
Spraying: Spray diluted product (trigger spray) evenly and make sure to wet surfaces completely. |
|
— |
Wiping: soak the wipe with diluted product in a bucket or spray the diluted product on the wipe. Apply diluted product by wiping evenly and make sure to wet surfaces completely. |
|
— |
Mopping: soak the mop with diluted product using a mop bucket with wringer. Apply diluted product by mopping evenly and make sure to wet surfaces completely. |
Rinse surfaces after use.
For control of bacteria, yeasts and fungi: Allow to take effect for 5 minutes.
For control of viruses: Allow to take effect for 15 minutes.
Dilution rate:
1 % dilution of the biocidal product (corresponding to 0,5 % H2O2) for bacteria, yeast, and viruses (1 ml of product with 50 % H2O2, add up to 100 ml with water) and 10 % dilution of the biocidal product (corresponding to 5 % H2O2) for fungi.
4.2.2. Use-specific risk mitigation measures
Unprotected persons are not allowed to be present during the application of the product. No access of third parties during application/treatment. Re-entry is only permitted once the air concentration has dropped below 0,9 ppm (1,25 mg/m3 ) or relevant lower national reference value.
For 1 % in use dilution:
During trigger spraying: Wear a respiratory protective equipment (RPE) aerosol and gas filter with an assigned protection factor of at least 4 (filter type (code letter, colour) and the standards to be specified by the authorisation holder within the product information). Wear protective gloves, clothes (coverall at least type 6) and goggles. Only for treatment of small surfaces (2 m2)
During manual application by mopping: Wear a respiratory protective equipment (RPE) aerosol and gas filter with an assigned protection factor of at least 10 (filter type (code letter, colour) and the standards to be specified by the authorisation holder within the product information)Wear protective gloves (EN374 or similar), goggles (EN 166 or similar), and coverall (EN 13034 or similar). A mop/brush with a long handle has to be used to apply the solution. Do not immerse hands in the solution.
During manual application by wiping: Wear a respiratory protective equipment (RPE) aerosol and gas filter with an assigned protection factor of at least 4 (filter type (code letter, colour) and the standards to be specified by the authorisation holder within the product information)Wear protective gloves (EN374 or similar), goggles (EN 166 or similar), and coverall (EN 13034 or similar). A mop/brush with a long handle has to be used to apply the solution. Do not immerse hands in the solution. Only for treatment of small surfaces (2 m2)
Wash hands after use.
For 10% in-use dilution
During trigger spraying: Wear a respiratory protective equipment (RPE) aerosol and gas filter with an assigned protection factor of at least 20 (filter type (code letter, colour) and the standards to be specified by the authorisation holder within the product information). Wear protective gloves (EN374 or similar), clothes (coverall at least type 6) and goggles (EN 166 or similar).Only for treatment of small surfaces (2 m2)
During manual application by mopping: Wear a respiratory protective equipment (RPE) aerosol and gas filter with an assigned protection factor of at least 40 (filter type (code letter, colour) and the standards to be specified by the authorisation holder within the product information). Wear protective gloves (EN374 or similar), goggles (EN 166 or similar), and coverall (EN 13034 or similar). A mop/brush with a long handle has to be used to apply the solution. Do not immerse hands in the solution. Ventilation rate minimum 1,5/h or with a window open.
During manual application by wiping: Wear a respiratory protective equipment (RPE) aerosol and gas filter with an assigned protection factor of at least 40 (filter type (code letter, colour) and the standards to be specified by the authorisation holder within the product information). Wear protective gloves (EN374 or similar), goggles (EN 166 or similar), and coverall (EN 13034 or similar). A mop/brush with a long handle has to be used to apply the solution. Do not immerse hands in the solution. Only for treatment of small surfaces (2 m2)
Wash hands after use.
The full references to the EN standards are available in Section 6.
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 of meta-SPC 5
4.2.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use of meta-SPC 5
4.2.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
see general directions for use of meta-SPC 5
4.3. Use description
Table 3
Disinfection of inner surfaces (incl. CIP and drinking water systems), concentrate
|
Product type |
PT04: Food and feed area |
|
Where relevant, an exact description of the authorised use |
/ |
|
Target organism(s) (including development stage) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data Scientific name: no data Common name: Legionella Development stage: no data |
|
Field(s) of use |
indoor use Disinfection of inner-surfaces (hard non-porous surfaces) in food industry (incl. cleaning in place) and inner surfaces in veterinary and human drinking water systems |
|
Application method(s) |
Method: closed system Detailed description: Filling the system with diluted concentrate. |
|
Application rate(s) and frequency |
1% dilution of the product (corresponding to 0,5 % H2O2) Number and timing of application: Prepare the dilution manually or use automated dosing system Use temperature: room temperature bacteria and yeasts; 1 % dilution of the product (corresponding to 0,5 % H2O2), contact time 5 minutes. fungi; 10 % dilution of the product (corresponding to 5 % H2O2), contact time 5 minutes. viruses; 1 % dilution of the product (corresponding to 0,5 % H2O2), contact time 15 minutes. Legionella, in drinking water systems; 1 % dilution of the product (corresponding to 0,5 % H2O2), contact time 30 minutes. Use frequency: up to 10 times a day |
|
Category(ies) of users |
professional |
|
Pack sizes and packaging material |
10 litres, 20 litres, 50 litres, 200 litres and 1 000 litres High Density Polyethene (HDPE) containers |
4.3.1. Use-specific instructions for use
Disinfection of drinking water systems can only be performed during an out of service period.
Systems cannot be in use during disinfection.
Dilute the product in the installation or system until a dilution of 1 % is reached.
Prepare the dilution manually or use automated dosing system.
Dilution rate for bacteria, yeasts, viruses and Legionella: 1 % dilution of the biocidal product (corresponding to 0,5 % H2O2) (1 ml of product with 50 % H2O2, add up to 100 ml with water).
Dilution rate for fungi: 10 % dilution of the biocidal product (corresponding to 5 % H2O2)
For control of bacteria, yeasts and fungi: Allow to take effect for 5 minutes.
For control of viruses: Allow to take effect for 15 minutes.
For control of Legionella, in drinking water systems: Allow to take effect for 30 minutes.
Rinse the system vigorously after having allowed the product to take effect in order to remove loosened dirt. Use a measuring strip to measure the amount hydrogen peroxide in the rinsing water. Rinse the piping system with pure tap water until no more hydrogen peroxide is measured in the rinse water.
4.3.2. Use-specific risk mitigation measures
see general directions for use of meta-SPC 5
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 of meta-SPC 5
4.3.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use of meta-SPC 5
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 of meta-SPC 5
4.4. Use description
Table 4
Room disinfection by fogging, concentrate
|
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) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Tuberculosis bacilli Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data |
|
Field(s) of use |
indoor use Disinfection of hard non-porous surfaces in healthcare. |
|
Application method(s) |
Method: fogging Detailed description: Fogging of diluted concentrate |
|
Application rate(s) and frequency |
Application Rate: 5 ml/m3 (corresponding to 2,5 ml H2O2/m3) 20 % dilution v/v of product (corresponding to 10 % H2O2) in fogging device Number and timing of application: Clean surfaces before disinfection treatment. Prepare the dilution manually or use automated dosing system 20 % dilution v/v of product (corresponding to 10 % H2O2) and add the diluted product to the fogging device Medibios basic; 5 ml/m3 (corresponding to 2,5 ml H2O2/m3) Room size 30-150 m3. Relative humidity: 40 - 80 % Particle size: lower than 1 - 5 μm The fogging time is regulated, the device will automatically stop. 2 hours contact time (at described conditions) Use temperature: room temperature Use frequency: up to 4 times a day |
|
Category(ies) of users |
professional |
|
Pack sizes and packaging material |
10 litres, 20 litres, 50 litres, 200 litres and 1 000 litres High Density Polyethene (HDPE) containers |
4.4.1. Use-specific instructions for use
Clean and dry the surfaces before disinfection.
If present, switch off the air-conditioning system. Close all windows. Close doors and where necessary, seal door cracks with adhesive tape. Make sure that outside the room there is a warning sign to not enter the room.
The product is used in combination with the fogging device Medibios Basic.
Dilution rate: 20 % dilution of the product (corresponding to 10 % H2O2) (20 ml of product with 50 % H2O2, add up to 100 ml with water)
Prepare the dilution manually or with an automated dosing system. Add the 20 % dilution to the fogging device using the dosing bottle.
Verify that there are no persons or animals present in the room.
Start the fogging device Medibios basic after setting the dosage per cubic meter. A delayed start of 15 seconds allows the user to leave the room before the fogging starts.
The device will automatically stop fogging. Allow a contact time of 2 hours after the biocidal product is fully diffused into the room.
After fogging and contact time, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment. The warning sign should be removed after this waiting period so that the public knows that the room can be entered again. Re-entry is only permitted once the air concentration has dropped below 0,9 ppm (1,25 mg/m3) or the corresponding national reference value, if applicable (see section ‘other information’ for details).
The professional user may only enter the room in emergency situations or to reactivate the ventilation when the hydrogen peroxide level has dropped below 36 ppm (50 mg/m3), considering RPE with APF 40 against vapour (full mask; type of RPE, coverall and gloves to be specified by the authorisation holder within the product information).
Use a calibrated sensor to confirm the enclosure is below 0,9 ppm (1,25 mg/m3) or the corresponding national reference value prior to re-entry.
During emergency situations, the professional user is only allowed to enter during treatment when wearing suitable protective personal equipment and a self-contained breathing apparatus. See section below.
The user shall always carry out a microbiological and chemical validation of the disinfection in the rooms to be disinfected (or in a suitable ‘standard room’, if applicable) with the devices to be used, after which a protocol for disinfection of these rooms can be made and used thereafter.
4.4.2. Use-specific risk mitigation measures
Make sure that outside the room there is a warning sign to not enter the room.
Leave the room within 15 seconds after starting the treatment and make sure that there are no persons or animals in the room.
2,5 hours after the end of the fogging, it is safe to enter the room again and to switch on the air-conditioning system. Remove the warning sign after this waiting period so that the public knows that the room can be entered again.
For re-entry in case of emergency: Wear a respiratory protective equipment (RPE) aerosol and gas filter consistent with EN 14387 or equivalent with an assigned protection factor of at least 40 (filter type (code letter, colour) to be specified by the authorisation holder within the product information).
Re-entry is only permitted once the air concentration has dropped below 0,9 ppm (1,25 mg/m3) or relevant lower national reference value. Use a calibrated sensor to confirm the enclosure is below 0,9 ppm (1,25 mg/m3) or relevant lower national reference value prior to re-entry.
The full references to the EN standards are available in Section 6.
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 of meta-SPC 5
4.4.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use of meta-SPC 5
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 of meta-SPC 5
4.5. Use description
Table 5
Equipment/instruments disinfection, concentrate
|
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) |
Scientific name: no data Common name: Bacteria Development stage: no data Scientific name: no data Common name: Yeasts Development stage: no data Scientific name: no data Common name: fungi Development stage: no data Scientific name: no data Common name: Viruses Development stage: no data |
|
Field(s) of use |
indoor use Disinfection of equipment in healthcare, non-healthcare and food industry. |
|
Application method(s) |
Method: open system: immersion Detailed description: Immersion and filling |
|
Application rate(s) and frequency |
Application Rate: Healthcare: 5 % H2O2; non-healthcare: 0,5 % H2O2 Food and/or feed areas bacteria and yeasts; 1 % dilution of the product (corresponding to 0,5 % H2O2) fungi; 10 % dilution of the product (corresponding to 5 % H2O2) Healthcare bacteria, yeasts, fungi and viruses; 10 % dilution of the product (corresponding to 5 % H2O2) Number and timing of application: Prepare the dilution manually or use automated dosing system Use temperature: room temperature Food and/or feed areas bacteria and yeasts; 1 % dilution of the product (corresponding to 0,5 % H2O2), contact time 5 minutes fungi; 10 % dilution of the product (corresponding to 5 % H2O2), contact time 5 minutes Healthcare bacteria, yeasts, fungi and viruses; 10% dilution of the product (corresponding to 5 % H2O2), contact time 15 minutes Use frequency: up to 30 times a day, max. 10 l per bath |
|
Category(ies) of users |
professional |
|
Pack sizes and packaging material |
10 litres, 20 litres, 50 litres, 200 litres and 1 000 litres High Density Polyethene (HDPE) containers |
4.5.1. Use-specific instructions for use
Prepare the dilution manually or use automated dosing system.
Submerge the equipment or machinery to be treated in the dilution. Allow to take effect for:
Food and/or feed areas: 5 minutes (bacteria, yeasts and fungi).
Dilution rate for bacteria and yeasts: 1% dilution of the product (corresponding to 0,5 % H2O2) (1 ml of product with 50 % H2O2, add up to 100 ml with water)
Dilution rate for fungi: 10% dilution of the product (corresponding to 5 % H2O2) (10 ml of product with 50 % H2O2, add up to 100 ml with water)
Healthcare: 15 minutes (bacteria, yeasts, fungi and viruses).
Dilution rate: 10 % dilution of the product (corresponding to 5 % H2O2): 10 ml of product with 50 % H2O2, add up to 100 ml with water;
Product dilution can only be used once.
If the equipment or machinery may come into contact with foodstuffs after disinfection, rinse it with pure water after treatment.
4.5.2. Use-specific risk mitigation measures
|
— |
During application in food/feed areas: Wear protective gloves (EN 374 or equivalent), wear protective goggles (EN ISO 16321 or equivalent). Wash hands after use. |
|
— |
During application in healthcare areas: Wear a respiratory protective equipment (RPE) aerosol and gas filter consistent with EN 14387 or equivalent with an assigned protection factor of at least 10 (filter type (code letter, colour) to be specified by the authorisation holder within the product information). Wear protective gloves (EN 374 or equivalent), goggles (EN ISO 16321 or equivalent), and coverall classified under EN 13034 or equivalent. |
The full references to the EN standards are available in Section 6
|
— |
Use a basket or another appropriate device for the dipping and retrieving of the equipment in the bath to avoid exposure. |
|
— |
Do not immerse hands in the bath |
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Wash hands after use. |
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The bath can be used only once and should be emptied immediately after use. |
4.5.3. Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
see general directions for use of meta-SPC 5
4.5.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
see general directions for use of meta-SPC 5
4.5.5. Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage
see general directions for use of meta-SPC 5
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 5
5.1. Instructions for use
see use-specific instructions for each use
5.2. Risk mitigation measures
Keep out of reach of children.
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Manual mixing and loading: Wear a respiratory equipment (RPE) aerosol and gas filter consistent with EN 14387 or equivalent with an assigned protection factor of at least 4 (filter type (code letter, colour) to be specified by the authorisation holder within the product information. Wear protective clothes consistent with EN 13034 or equivalent, gloves classified under EN 374 or equivalent and goggles consistent with EN ISO16321 or equivalent. Wash hands after use. |
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Automated mixing and loading: Wear protective clothes consistent with EN 13034 or equivalent, gloves classified under EN 374 or equivalent) and goggles consistent with EN ISO16321 or equivalent). |
The full references to the EN standards are available in Section 6.
This 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 reference to this act.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
First aid measures:
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IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. |
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If symptoms: Call 112 or ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. |
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IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or ambulance for medical assistance. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE. |
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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. |
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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 or ambulance for medical assistance. |
Environmental precautions: Prevent soil and water pollution. Prevent spreading in sewers.
5.4. Instructions for safe disposal of the product and its packaging
Dispose of this material and its container to hazardous or special waste collection point. Must not be disposed together with household garbage. Do not allow product to reach sewage system. Disposal should be in accordance with Local Authority Regulations.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Store in dry, dark and well-ventilated area. Protect from frost. Store below 30°C. Protect from direct sunlight. Keep container tightly closed. Must only be kept in original packaging. Shelf life is 24 months.
6. OTHER INFORMATION
Professionals (including industrial users) means trained professionals if this is required by national legislation.
The full titles of the EN standards referenced in sections 4.1.2, 4.2.2, 4.4.2, 4.5.2 and 5.2 ‘Risk mitigation measures’ are:
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EN 374 - Protective gloves against dangerous chemicals and micro-organisms |
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EN ISO 16321 - Eye and face protection for occupational use |
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EN 13034 - Protective clothing against liquid chemicals - Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment) |
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EN 14387 - Respiratory Protective Devices |
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).
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
7.1. Trade name(s), authorisation number and specific composition of each individual product
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Trade name(s) |
HP-BPF-10 |
Market area: EU |
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Authorisation number |
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EU-0031657-0010 1-5 |
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Common name |
IUPAC name |
Function |
CAS number |
EC number |
Content (%) |
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Hydrogen peroxide |
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Active substance |
7722-84-1 |
231-765-0 |
49,5 % (w/w) |
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ELI: http://data.europa.eu/eli/reg_impl/2026/158/oj
ISSN 1977-0677 (electronic edition)