Commission Implementing Regulation (EU) 2025/1887 of 17 September 2025 granting a Union authorisation for the single biocidal product CLARMARIN® 350 LD in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2025-09-17
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, decontamination, market approval, oxide, pharmaceutical product








L_202501887EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/1887


18.9.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/1887
of 17 September 2025
         
granting a Union authorisation for the single biocidal product ‘CLARMARIN® 350 LD’ 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 30 July 2024, Evonik Operations GmbH submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for Union authorisation of the same single biocidal, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named ‘CLARMARIN® 350 LD’, of product-type 2, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-KL099229-17 in the Register for Biocidal Products. The application referred to the single biocidal product ‘CLARMARIN® 350’ (authorisation number EU-0028964-0005), which is a part of the related reference biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’. The application also indicated the authorisation number of the related reference biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’ authorised by Commission Implementing Regulation (EU) 2023/2183 (3), with authorisation number EU-0028964-0000.












(2)


The single biocidal product ‘CLARMARIN® 350 LD’ 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-type 2.












(3)


On 30 October 2024, the Agency submitted to the Commission its opinion (4), in accordance with Article 6 of Implementing Regulation (EU) No 414/2013.












(4)


In its opinion, the Agency concludes that the proposed differences between the single biocidal product ‘CLARMARIN® 350 LD’ and the related single reference biocidal product ‘CLARMARIN® 350’, which is a part of the related reference biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’ are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (5), and that based on the assessment of the related reference biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’ and subject to compliance with the draft SPC, the same single biocidal product ‘CLARMARIN® 350 LD’ meets the conditions laid down in Article 19(1) of Regulation (EU) No 528/2012.












(5)


On 24 September 2024, the Agency transmitted to the Commission the draft SPC of ‘CLARMARIN® 350 LD’ in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.












(6)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same single biocidal product ‘CLARMARIN® 350 LD’.












(7)


The expiry date of the authorisation should be aligned with the expiry date of the authorisation of the related reference biocidal product family ‘Evonik’s Hydrogen Peroxide Product Family’.












(8)


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





HAS ADOPTED THIS REGULATION:



Article 1
A Union authorisation with authorisation number EU-0033557-0000 is hereby granted to Evonik Operations GmbH for the making available on the market and use of the same single biocidal product ‘CLARMARIN® 350 LD’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 8 October 2025 until 31 October 2033.


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, 17 September 2025.


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)  Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/414/oj).

(3)  Commission Implementing Regulation (EU) 2023/2183 of 18 October 2023 granting a Union authorisation for the biocidal product family Evonik’s Hydrogen Peroxide Product Family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L, 2023/2183, 19.10.2023, ELI: http://data.europa.eu/eli/reg_impl/2023/2183/oj).

(4)  European Chemicals Agency opinion of 30 October 2024 on the Union authorisation of the same single biocidal product ‘CLARMARIN® 350 LD’, https://echa.europa.eu/opinions-on-union-authorisation.

(5)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4, ELI: http://data.europa.eu/eli/reg_impl/2013/354/oj).




ANNEX
Summary of product characteristics for a biocidal product

CLARMARIN® 350 LD

Product type(s)

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

Authorisation number: EU-0033557-0000

R4BP asset number: EU-0033557-0000

1.   ADMINISTRATIVE INFORMATION

1.1.   Trade name(s) of the product







Trade name(s)


CLARMARIN® 350 LD
BEIBLEACH WP 35




1.2.   Authorisation holder








Name and address of the authorisation holder


Name


Evonik Operations GmbH




Address


Rellinghauser Straße 1 - 11 45128 Essen DE




Authorisation number


 


EU-0033557-0000





R4BP asset number



 


EU-0033557-0000




Date of the authorisation


 


8 October 2025




Expiry date of the authorisation


 


31 October 2033




1.3.   Manufacturer(s) of the product







Name of manufacturer


Evonik Antwerpen NV




Address of manufacturer


Tijsmanstunnel West 2040 Antwerpen Belgium




Location of manufacturing sites


Evonik Antwerpen NV Tijsmanstunnel West 2040 Antwerpen Belgium













Name of manufacturer


Evonik Operations GmbH




Address of manufacturer


Rellinghauser Straße 1-11 45128 Essen Germany




Location of manufacturing sites


Evonik Operations GmbH Untere Kanalstr. 3 79618 Rheinfelden Germany













Name of manufacturer


Evonik Peroxid GmbH




Address of manufacturer


Industriestraße 1 9721 Weißenstein Austria




Location of manufacturing sites


Evonik Peroxid GmbH Industriestraße 1 9721 Weißenstein Austria













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 Oosterhorn 14 9936 HD Farmsum Netherlands (the)













Name of manufacturer


Evonik España y Portugal SA




Address of manufacturer


Afueras s/n 50784 La Zaida Spain




Location of manufacturing sites


Evonik España y Portugal SA C/ Afueras s/n. 50784 La Zaida Spain




1.4.   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 Tijsmanstunnel West 2040 Antwerpen Belgium













Active substance


Hydrogen peroxide




Name of manufacturer


Evonik Operations GmbH




Address of manufacturer


Rellinghauser Straße 1-11 45128 Essen Germany




Location of manufacturing sites


Evonik Operations GmbH 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 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 Oosterhorn 14 9936 HD Farmsum Netherlands (the)













Active substance


Hydrogen peroxide




Name of manufacturer


Evonik España y Portugal SA




Address of manufacturer


Afueras s/n 50784 La Zaida Spain




Location of manufacturing sites


Evonik España y Portugal SA C/ Afueras s/n. 50784 La Zaida Spain




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 (%)




Hydrogen peroxide


 


Active substance


7722-84-1


231-765-0


35 % (w/w)




2.2.   Type(s) of formulation

SL Soluble concentrate
3.   HAZARD AND PRECAUTIONARY STATEMENTS







Hazard statements


H302: Harmful if swallowed.
H315: Causes skin irritation.
H318: Causes serious eye damage.
H335: May cause respiratory irritation.
H412: Harmful to aquatic life with long lasting effects.
H272: May intensify fire; oxidiser.




Precautionary statements


P261: Avoid breathing vapours.
P264: Wash hands thoroughly after handling.
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 clothing / eye protection / face protection.
P301+P312: IF SWALLOWED: Call a POISON CENTER / doctor / physician if you feel unwell.
P330: Rinse mouth.
P302+P352: IF ON SKIN: Wash with plenty of water/ soap.
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P312: Call a POISON CENTER/doctor/physician if you feel unwell.
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 / doctor.
P332+P313: If skin irritation occurs: Get medical advice.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P405: Store locked up.
P501: Dispose of contents in accordance with local requirements.
P501: Dispose of container in accordance with local requirements.
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)

4.1.   Use description


Table 1


Laundry disinfection in closed washing machines by dosing







Product type


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




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: bacteria
Development stage: -
Common name: yeasts
Development stage: -
Common name: viruses
Development stage: -
Common name: fungi
Development stage: -




Field(s) of use


indoor use
Laundry disinfection in washing machines.




Application method(s)


Method: Loading (dosing)
Detailed description:
The product is automatically dosed into the closed washing machine during the washing process (main wash).




Application rate(s) and frequency


Application Rate:
0,019 – 0,029% (w/w) hydrogen peroxide.
The biocidal products are diluted accordingly in order to achieve an in-use concentration in the range of 0,019 – 0,029% (w/w). For example, in the case of 35% (w/w) hydrogen peroxide product: 0,5 ml or 0,75 ml concentrate add water up to 1 litre to achieve 0,019% (w/w) or 0,029% (w/w). For products with different concentrations of hydrogen peroxide the values have to be adjusted accordingly.
Number and timing of application:
Frequency: Daily / if required
Bacteria, yeasts, fungi: In use concentration 0,019% (w/w) hydrogen peroxide in the wash solution.
Alkaline buffering agent: 0,6 ml/l BEIPUR ANP.
Contact time: 10 minutes
Temperature: 70°C
Viruses: In use concentration 0,029% (w/w) hydrogen peroxide in the wash solution.
Alkaline buffering agent: 0,6 ml/l BEIPUR ANP
Contact time: 10 minutes
Temperature: 80°C
Cloth: liquid ratio = 1:4




Category(ies) of users


professional




Pack sizes and packaging material


HDPE bottle 1, 5 litres
HDPE jerry can 10, 20, 30, 60 litres
HDPE drum 200 litres
HDPE container 1000 litres
HDPE ISO tank 20m3





4.1.1.   Use-specific instructions for use

The product and alkaline buffering agent (BEIPUR ANP) are automatically dosed into the closed washing machine during the washing process. The dosing of both components, i.e. the biocidal product and the alkaline buffering agent BEIPUR ANP, is realised via two separate pipes and dosing stations. Biocidal product and alkaline buffering agent should not be mixed prior the dosing into the washing machine. Treatment Interval - daily / if required (0,5 hours / day).
4.1.2.   Use-specific risk mitigation measures

Wear chemical resistant goggles consistent with European Standard EN 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN 374 or equivalent, face shield and RPE (APF = 10) during mixing and loading. Glove and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.
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 Council Directive 98/24/EC.
Technical RMM: Local exhaust ventilation (50 %) and good standard of general ventilation (3 ACH). Observe label instructions.
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

No use specific first aid instructions and emergency measures to protect the environment. See general directions for use.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

No use specific instructions for safe disposal of the product and its packaging. See general directions for use.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

No use specific instructions of storage and shelf-life of the product under normal conditions of storage. See general directions for use.
5.   GENERAL DIRECTIONS FOR USE (1)

5.1.   Instructions for use

See use specific instructions for each use.
5.2.   Risk mitigation measures

See use specific risk mitigation measures for each use.
Observe label instructions.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment



First aid instructions


IF SWALLOWED: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/ambulance for medical assistance. Information to Healthcare personnel/doctor: Initiate life support measures if needed, thereafter call a POISON CENTRE.
IF ON SKIN: Immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.
IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112/ambulance for medical assistance.
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing.
If symptoms: Call 112/ambulance for medical assistance.
If no symptoms: Call a POISON CENTRE or a doctor.


Accidental release measures


Large spillage: Collect product in suitable containers (for example made of plastic) using appropriate equipment (for example liquid pump) for disposal. Never return spills in original containers for re-use. Keep away from flammable and incompatible substances. Rinse away any residue with plenty of water. Dispose of absorbed material in accordance with the applicable environmental regulations.
Small spillage: Dilute product with lots of water and rinse away or absorb with liquid-binding material (for example diatomaceous earth or universal binder). Pick up mechanically and collect in suitable containers. Clean contaminated surface thoroughly. Pack and label wastes like the product. Do not detach label from the delivery containers prior to disposal.
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose of unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer depending on local requirements.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage



Advice on protection against fire and explosion


Store away from direct sunlight and heat sources.
Store away from sources of ignition - No smoking.
Store away from flammable substances.
Store away from incompatible substances.


Storage


Temperature requirement- during storage maximum 40 °C and protect from frost.
Store in clean, dry and well- ventilated places.
Transport and store container in upright position only.
Always close container tightly after removal of product.
Avoid leakage and residues of the product on the containers.


Advice on common storage


Do not store together with alkalis, reductants, metallic salts (risk of decomposition).
Do not store together with organic solvents (risk of explosion).


Shelf-life


24 months
6.   OTHER INFORMATION

The full titles of the EN standards referenced in the “Use-specific mitigation measures” sections are:
EN 16321 - Eye and face protection for occupational users
EN 374 – Protective gloves against chemicals and micro-organisms
The Council Directive referenced in the “Use-specific mitigation measures” sections is: 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[RMJ1], p.11).


(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.



ELI: http://data.europa.eu/eli/reg_impl/2025/1887/oj
ISSN 1977-0677 (electronic edition)