Date: 2025-09-18Category: Not ApplicableState: Union GovernmentCountry: Europe
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
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary:**
Commission Implementing Regulation (EU) 2025/1887 grants Union authorisation EU00335570000 to Evonik Operations GmbH for the single biocidal product CLARMARIN 350 LD, product type 2, containing hydrogen peroxide. The authorisation is valid from October 8, 2025, to October 31, 2033. This regulation aligns with Regulation (EU) No 528/2012 concerning biocidal products.
**Key Points / Main Content:**
* **Authorisation Details:**
* A Union authorisation is granted for CLARMARIN 350 LD with authorisation number EU00335570000.
* The authorisation holder is Evonik Operations GmbH.
* The active substance is hydrogen peroxide.
* The product type is PT02: Disinfectants and algaecides not intended for direct application to humans or animals.
* The authorisation is valid from October 8, 2025, until October 31, 2033.
* **Product Information:**
* Trade names include CLARMARIN 350 LD and BEIBLEACH WP 35.
* The formulation type is SL (Soluble concentrate).
* The product contains 35% w/w hydrogen peroxide.
* **Manufacturers:**
* The regulation lists the names and addresses of multiple manufacturers of both the product and the active substance (hydrogen peroxide) across several locations in Europe.
* **Hazard and Precautionary Statements:**
* Includes hazard statements (H-statements) such as "Harmful if swallowed," "Causes skin irritation," and "Causes serious eye damage."
* Lists precautionary statements (P-statements) regarding prevention, response, storage, and disposal.
* **Authorised Uses:**
* Specifies the authorised use as laundry disinfection in closed washing machines via dosing.
* Details target organisms (bacteria, yeasts, viruses, fungi), application methods, rates, frequency, and contact times.
* Defines categories of users as professional.
* Specifies pack sizes and packaging materials.
* **Use-Specific Instructions and Risk Mitigation:**
* Provides specific instructions for the use of the product and alkaline buffering agent BEIPUR ANP in closed washing machines.
* Outlines risk mitigation measures, including the use of personal protective equipment (goggles, protective clothing, gloves, face shield, RPE) during mixing and loading.
* **General Directions for Use:**
* Refers to use-specific instructions and risk mitigation measures.
* Includes first aid instructions for various exposure routes (swallowing, skin contact, eye contact, inhalation).
* Describes accidental release measures and instructions for safe disposal of the product and its packaging.
* Specifies conditions of storage, including temperature requirements and incompatibility with certain substances.
* States a shelf life of 24 months.
**Impact Analysis:**
* **Evonik Operations GmbH:**
* Impact: Granted Union authorisation for making available and using CLARMARIN 350 LD.
* Action Required: Ensure compliance with the summary of product characteristics in the Annex, including proper manufacturing, labeling, and distribution of the product. Comply with risk mitigation measures and provide necessary information to users.
* **Professional Users of CLARMARIN 350 LD:**
* Impact: Governed by the authorised uses and specific instructions outlined in the regulation.
* Action Required: Adhere to the use-specific instructions, risk mitigation measures, and safety precautions detailed in the regulation and product label.
* **Manufacturers of CLARMARIN 350 LD and Hydrogen Peroxide:**
* Impact: Required to manufacture the product and its active substance according to the specifications and locations listed in the regulation.
* Action Required: Maintain compliance with manufacturing standards and ensure the product meets the required composition and quality.
* **European Chemicals Agency (ECHA):**
* Impact: Assessed the application and provided an opinion to the Commission.
* Action Required: Continue to monitor the product and ensure compliance with the regulation.
* **Member States:**
* Impact: Directly applicable in all Member States.
* Action Required: Ensure the regulation is enforced within their jurisdiction and that relevant authorities are aware of the authorisation.
Key Entities Referenced
CLARMARIN 350 LD: Single biocidal product granted Union authorisation under the regulation.
Regulation EU No 528/2012: Regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
European Chemicals Agency: The Agency that received the application and submitted its opinion to the Commission.
Evonik Operations GmbH: The company that submitted the application for Union authorisation and the authorisation holder.
Evoniks Hydrogen Peroxide Product Family: Related reference biocidal product family.
Brussels: Location where the Commission adopted the regulation.
Ursula VON DER LEYEN: The President of the European Commission.
Hydrogen peroxide: The active substance contained within the single biocidal product CLARMARIN 350 LD.
Official Journal EN
of the European Union 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.
(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).
ELI: http://data.europa.eu/eli/reg_impl/2025/1887/oj 1/9EN
OJ L, 18.9.2025
(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
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OJ L, 18.9.2025
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 Evonik Operations GmbH
Name and address of the authorisation holder
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
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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
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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 Active 7722-84-1 231-765-0 35 % (w/w)
peroxide substance
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.
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OJ L, 18.9.2025
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 Common name: bacteria
stage) 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
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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.
(1) Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses.
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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.
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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).
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