Commission Implementing Regulation (EU) 2024/267 of 17 January 2024 granting a Union authorisation for the single biocidal product DEC-SPORE 200 Plus in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

Article 1

A Union authorisation with authorisation number EU-0030727-0000 is granted to Veltek Associates Inc. Europe for the making available on the market and use of the single biocidal product ‘DEC-SPORE 200 Plus’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 7 February 2024 to 31 January 2034.

Article 2

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

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

ANNEX

1. ADMINISTRATIVE INFORMATION

1.1.   Trade name(s) of the product

Trade name(s)	DEC-SPORE 200 Plus DEC-SPORE 300 Plus

1.2.   Authorisation holder

Name and address of the authorisation holder	Name	Veltek Associates Inc. Europe
Address	Rozengaard 1940 8212DT Lelystad NL
Authorisation number		EU-0030727-0000
R4BP asset number		EU-0030727-0000
Date of the authorisation		7 February 2024
Expiry date of the authorisation		31 January 2034

1.3.   Manufacturer(s) of the product

Name of manufacturer	Veltek Associates, Inc.
Address of manufacturer	15 Lee Blvd. PA19355 Malvern United States (the)
Location of manufacturing sites	Veltek Associates, Inc. site 1 15 Lee Blvd. PA19355 Malvern United States (the)

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

Active substance	Peracetic acid
Name of manufacturer	Evonik Operations GmbH (Acting for Evonik Active Oxygens, LLC (US))
Address of manufacturer	One Commerce Square, 2005 Market Street, Suite 3200 19103 Philadelphia, PA United States (the)
Location of manufacturing sites	Evonik Operations GmbH (Acting for Evonik Active Oxygens, LLC (US)) site 1 Tonawanda Plant, 35 Sawyer Avenue 14150 Tonawanda, NY United States (the)

2. PRODUCT COMPOSITION AND FORMULATION

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

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Peracetic acid		active substance	79-21-0	201-186-8	5,1  % (w/w)
Acetic acid (glacial)	Acetic acid	Non-Active substance	64-19-7	200-580-7	10,4  % (w/w)
Hydrogen peroxide	Hydrogen peroxide	Non-Active substance	7722-84-1	231-765-0	21,7 % (w/w)

2.2.   Type(s) of formulation

SL Soluble concentrate

3. HAZARD AND PRECAUTIONARY STATEMENTS

Hazard statements

H242: Heating may cause a fire. H290: May be corrosive to metals. H302: Harmful if swallowed. H312: Harmful in contact with skin. H332: Harmful if inhaled. H410: Very toxic to aquatic life with long lasting effects. H314: Causes severe skin burns and eye damage. EUH071: Corrosive to the respiratory tract.

Precautionary statements

P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. P234: Keep only in original packaging. P260: Do not breathe vapours. P270: Do not eat, drink or smoke when using this product. P271: Use only outdoors or in a well-ventilated area. P273: Avoid release to the environment. P280: Wear protective gloves. P280: Wear protective clothing. P280: Wear eye protection. P280: Wear face protection. P303+P361+P353: IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water [or shower]. P301+P330+P331: IF SWALLOWED: rinse mouth. Do NOT induce vomiting. 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. P362+P364: Take off contaminated clothing and wash it before reuse. P501: Dispose of contents to in accordance with local/national regulations. P501: Dispose of container to in accordance with local/national regulations. P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing. P405: Store locked up.

4. AUTHORISED USE(S)

4.1.   Use description

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: Bacteria Common name: Bacteria Development stage: Bacterial cells Scientific name: Yeast species Common name: Yeasts Development stage: Cellular yeasts
Field(s) of use	indoor use Disinfectant for industrial use only. For indoor use on floors, walls and other hard non-porous surfaces such as, but not limited to, general surfaces, tools, tables, shelves, etc. in clean rooms of manufacturing facilities for pharmaceutical, biopharmaceutical, medical device, healthcare and diagnostic products.
Application method(s)	Method: Surface disinfection by soaking or trigger spraying, to distribute the product mop, cloth or wipe can be used Detailed description: -
Application rate(s) and frequency	Application rate: 100 ml/m2 Dilution (%): 0,5 % v/v Dilute product 1:200 in water (for example 5 ml product into 995 ml water) by manual dilution or use the SimpleMix system Number and timing of application: Typical application frequency of 1 application per day Contact time: 5 minutes for bactericidal and yeasticidal treatment,
Category(ies) of users	industrial
Pack sizes and packaging material	75 ml high density polyethylene (HDPE) bottles (opaque) 473 ml HDPE bottles (opaque) - SimpleMix package 503 ml HDPE bottles (opaque) 3,79 litre HDPE bottles (opaque) - SimpleMix package 3,79 litre HDPE bottles (opaque) Each bottle at least double bagged (more bags upon request of customer) in clear low density polyethylene (LDPE) bags heat sealed shut, contained in cardboard shipping cases. Not offered as single bottles. Only sold in full sealed boxes.

Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Prepare a disinfectant dilution (1:200). Apply thoroughly as directed in directions for use: wet the surface thoroughly and allow to air dry. No rinsing is necessary but may be done if desired.

Preparation of dilution manually

Mix a use dilution of 1:200.

Preparation of dilution by using the SimpleMix package. (See cap on bottle or SimpleMix Instruction brochure for written directions)

The SimpleMix container (473 ml or 3,79 litres) is pre-dosed with water and product concentrate that results in a 1:200 use dilution.

Use a mechanical spray device for application of the product or apply the product onto the surface by other means and then use a cloth, mop or wipe for distribution. Make sure to wet the surfaces completely, allow to take effect for at least 5 minutes.

For use on walls, multiple applications might be necessary to wet the surface completely.

No rinsing is necessary but may be done, if desired.

For the undiluted product:

Provide adequate ventilation with a minimum of 10 air changes per hour (ACH). The lengh of stay in the treated area should be minimised.

Use of respiratory protective equipment (RPE) in accordance with European Standard EN 14387 or equivalent providing a protection factor of 4 is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a half/full mask with combination filter gas/P2 is required (filter type AB1, brown/grey filter type).

Wear protective chemical-resistant gloves (classified under European Standard EN 374 or equivalent) glove material to be specified by the authorisation holder within product information and a protective coverall (at least Type 6 EN 13034 or equivalent) which is impermeable for the biocidal product during product handling.

The use of eye or face protection in accordance with EN 16321 or equivalent during handling of the product is mandatory.

Dispose of protective gloves after use.

This is without prejudice to the application by employers 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 titles of the EN standards and legislation.

For diluted product (0,5% v/v):

No risk mitigation measures required for the diluted product.

See general directions for use

See general directions for use

See general directions for use

4.2.   Use description

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: Bacterial spores Common name: Bacterial spores Development stage: Bacterial spores Scientific name: Bacteria Common name: Bacteria Development stage: Bacteria cells Scientific name: Yeast species Common name: Yeasts Development stage: Cellular yeasts Scientific name: Fungi Common name: fungi Development stage: Fungi
Field(s) of use	indoor use Disinfectant for industrial use only. For indoor use on floors, walls and other hard non-porous surfaces such as, but not limited to, general surfaces, tools, tables, shelves, etc. in clean rooms of manufacturing facilities for pharmaceutical, biopharmaceutical, medical device, healthcare and diagnostic products.
Application method(s)	Method: Surface disinfection by soaking or trigger spraying, to distribute the product mop, cloth or wipe can be used Detailed description: -
Application rate(s) and frequency	Application rate: 100 ml/m2 Dilution(%): 6,7% v/v Dilute product 1:15 in water or (for example 67 ml into 933 ml water) by manual dilution or use the SimpleMix System Number and timing of application: Typical application frequency of 1 application per day Contact time: 5 minutes for bactericidal, yeasticidal and fungicidal treatment 15 minutes for sporicidal treatment
Category(ies) of users	industrial
Pack sizes and packaging material	75 ml high density polyethylene (HDPE) bottles (opaque) 473 ml HDPE bottles (opaque) - SimpleMix package 503 ml HDPE bottles (opaque) 3,79 litre HDPE bottles (opaque) - SimpleMix package 3,79 litre HDPE bottles (opaque) Each bottle at least double bagged (more bags upon request of customer) in clear low density polyethylene (LDPE) bags heat sealed shut, contained in cardboard shipping cases. Not offered as single bottles. Only sold in full sealed boxes.

Thoroughly clean and rinse the surface. Remove excess water from the surface before disinfection, if appropriate. Prepare a disinfectant dilution (1:15). Apply thoroughly as directed in directions for use: wet the surface thoroughly and allow to air dry. No rinsing is necessary but may be done if desired.

Preparation of dilution manually:

Mix a use dilution of 1:15.

Preparation of dilution by using the SimpleMix package (473 ml or 3,79 litre). (See cap on bottle or SimpleMix Instruction brochure for written directions).

[Note: The SimpleMix container labelled ‘Sporicide’ results in a 1:15 use dilution.]

(See cap on bottle or SM-01-E SimpleMix Instructions brochure for written directions.)

Use a mechanical spray device for application of the product or apply the product onto the surface by other means and then use a cloth, mop or wipe for distribution. Make sure to wet the surfaces completely, allow to take effect for at least 5 minutes for bactericidal, yeasticidal and fungicidal treatment, 15 minutes for sporicidal treatment.

For use on walls, multiple applications might be necessary to wet the surface completely.

No rinsing is necessary but may be done, if desired.

For the undiluted product:

Provide adequate ventilation with a minimum of 10 air changes per hour (ACH). The length of stay in the treated area should be minimised.

Use of respiratory protective equipment (RPE) in accordance with European Standard EN 14387 or equivalent providing a protection factor of 4 is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a half/full mask with combination filter gas/P2 is required (filter type AB1, brown/grey filter type).

Wear protective chemical resistant gloves (in accordance with EN 374 or equivalent)- glove material to be specified by the authorisation holder within product information and a protective coverall (at least Type 6 EN13034 or equivalent) which is impermeable for the biocidal product during product handling.

The use of eye or face protection in accordance with EN 16321 or equivalent during handling of the product is mandatory.

Dispose of protective gloves after use.

This is without prejudice to the application by employers of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work.

For the diluted product (6,7% v/v):

Provide adequate ventilation with a minimum of 10 ACH. The length of stay in the treated area should be minimised.

Wear protective chemical resistant gloves in accordance with EN 374 or equivalent -glove material to be specified by the authorisation holder within product information-and a protective coverall (at least Type 6 EN 13034 or equivalent) which is impermeable for the biocidal product.

Use of respiratory protective equipment (RPE) in accordance with EN 14387 or equivalent providing a protection factor of 4 for wiping is mandatory and a factor 10 for trigger spraying and mopping. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a half/full mask with combination filter gas/P2 is required (filter type AB1, brown/grey filter type).

In case of a ventilation rate of 30 ACH:

Use of respiratory protective equipment (RPE) in accordance with EN 14387 or equivalent providing a protection factor of 4 for trigger spraying and mopping is mandatory.

Wear protective chemical resistant gloves in accordance with EN 374 or equivalent - glove material to be specified by the authorisation holder within the product information and a protective coverall (at least Type 6 EN13034 or equivalent) which is impermeable for the biocidal product during product handling.

The use of eye or face protection during handling of the product is mandatory.

Dispose of protective gloves after use.