LegalizeCommission Implementing Regulation (EU) 2025/1906 of 12 September 2025 granting a Union authorisation for the biocidal product family GA 24-50 BPF in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
The dose and frequency strongly depend on the formulation and intended use of the matrix to which the preservative is added. Therefore, the user shall determine dosage requirements for their specific matrix/system to be preserved. The lowest effective dose shall be used. If needed, consult the authorisation holder of the preservative product.
4.17.2. Use-specific risk mitigation measures
If discharged into seawater 0,2 mg/L glutaraldehyde must not be exceeded in the hydrotesting and mothballing fluids. This concentration can be achieved either by slow release and/or long retention times resulting in degradation of glutaraldehyde and/or by dilution and/or by addition of sodium bisulphite at pH 5 (release after at least 20 minutes) or addition of sodium hydroxide to pH 12 (release after at least 10-16 hours) as degradation aids. Hydrotest and mothballing water containing up to 750 mg/L glutaraldehyde after the pressure test can be used for re-injection. Run lab test to determine the soiling dependent dosage and degradation rate in use.
When applied onshore, preserved fluids must be recycled or disposed of as hazardous waste. If release to the sewer is unavoidable, the concentration shall not exceed 1 mg glutaraldehyde/L.
4.17.3. 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.
4.17.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.17.5. 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.
4.18. Use description
Table 18
Slimicide treatment in water-based fracturing fluids for the oil and gas industry
| Product type | PT12: Slimicides |
| Where relevant, an exact description of the authorised use | Not relevant. |
| Target organism(s) (including development stage) | Scientific name: no data Common name: bacteria Development stage: no data |
| Field(s) of use | Outdoor use Slimicide treatment in water-based fracturing fluids for the oil and gas industry (i.e. shale gas extraction, wet shale extraction, shale oil extraction, production from tight gas reservoirs, production of coal bed methane and fracturing in conventional reservoirs). |
| Application method(s) | Method: closed system Detailed description: Dosing using automated pumps directly into pipelines or prepared in a mixing tank before in-line application. |
| Application rate(s) and frequency | Application Rate: 50 to 1 000 g glutaraldehyde per m3 fracturing fluid, in the hydraulic fracturing water matrix. Number and timing of application: In the hydraulic fracturing industry the application of the biocidal product is typically a single injection, which happens during the actual fracturing. A new biocide addition is only done when the well is re-fractured. Refracturing is rare but can be performed up to 20 times during the lifetime of a well. The lifetime of a well can reach up to 20 years. |
| Category(ies) of users | Industrial Trained professional |
| Pack sizes and packaging material | — Pails: 25L nominal, material of construction is high density polyethylene. — Drums: 220L nominal, material of construction is high density polyethylene. — IBC (intermediate bulk container): 1 000 L nominal, material of construction is high density polyethylene. — Bulk tank truck: 28 MT max. gross weight, material of construction is stainless steel. — Bulk ISO tank: 20 MT max. gross weight, material of construction is stainless steel. — Offshore-suitable drums: 200L, material of construction is high density polyethylene. — Offshore-suitable semi-bulk containers: 1 000 L, material of construction is stainless steel. — Offshore-suitable containers: 500 IG (2 273 L), material of construction is stainless steel. — Offshore-suitable containers: 1 000 IG (4 546 L), material of construction is stainless steel. |
4.18.1. Use-specific instructions for use
Glutaraldehyde is typically applied through a closed system to a mixing tank using a pump Glutaraldehyde may be used in combination with other chemistries such as friction reducers, gelling agents, proppants, and corrosion inhibitors, and applied together with these chemistries in the mixing tank(s). If used for intermittent treatments during operations, a stream of glutaraldehyde will be directly dosed into the process water stream from a separate tank into a closed system, thereby significantly reducing the chance of exposure.
Dose 50 to 1 000 g glutaraldehyde per m3 fracturing fluid, in the hydraulic fracturing water matrix.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, the user shall determine dosage requirements for their specific matrix/system to be preserved. The lowest effective dose shall be used. If needed, consult the authorisation holder of the preservative product.
4.18.2. Use-specific risk mitigation measures
Preserved fracturing fluids are reused where applicable. If discharged into seawater 0,2 mg glutaraldehyde/L fracturing fluid must not be exceeded. This concentration can be achieved either by slow release and/or long retention times resulting in degradation of glutaraldehyde and/or by dilution and/or by addition of sodium bisulphite at pH 5 (release after at least 20 minutes) or addition of sodium hydroxide to pH 12 (release after at least 10-16 hours) as degradation aids. Run lab test to determine the soiling dependent dosage and degradation rate in use.
When applied onshore, preserved fluids must be recycled or disposed of as hazardous waste. If release to the sewer is unavoidable, the concentration shall not exceed 1 mg glutaraldehyde/L.
4.18.3. 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. In addition:
Conditions preventing emissions to water:
Emissions to surface water are prevented through the design of the installation. By way of example spills, leaks and cleaning solutions may be drained to a lined storage area, preventing release to surface water. Sub-surface releases of fluid during the fracturing process are prevented from reaching aquifers through the presence of relatively
impermeable formations above the target formation. This limits upward migration of fluid. This is also relevant for recovered fluids that are re-injected for use or disposal. A minimum vertical separation distance between the target formation and aquifer should be respected. National legislation may also require a minimum depth
Recovered water may finally be discharged via one or more large-scale waste water treatment plants where a combination of physical and biological treatments will reduce emissions to the receiving water.
Conditions preventing emissions to soil:
Emissions, through downward migration are prevented through the design of the installation. By way of example spills, leaks and cleaning solutions may be prevented from downward migration to soil by the employment of a non-permeable membrane below the well pad. Sludge from treatment works should not be spread on land.
Existence of standard municipal sewage treatment plant
Waste contractors employed to dispose of recovered water, may do so via a waste water treatment plant, depending on the properties of the water and conditions of local regulations.
4.18.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use. Additional:
Contaminated water arising from cleaning will be collected and removed for disposal according to EU and local regulations and conditions.
Waste product remaining in containers after use will be returned, in the containers, to the supplier for cleaning/refilling.
Waste sludge from treatment works will be handled as industrial waste and not spread on land.
4.18.5. 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.
4.19. Use description
Table 19
Slimicide treatment in produced water for recycling in the oil and gas industry
| Product type | PT12: Slimicides |
| Where relevant, an exact description of the authorised use | Not relevant. |
| Target organism(s) (including development stage) | Scientific name: no data Common name: bacteria Development stage: no data |
| Field(s) of use | Outdoor use Slimicide treatment in produced water for recycling in the oil and gas industry. |
| Application method(s) | Method: closed system Detailed description: Dosing using pumps directly into the water stream before being mixed with fresh injection water and pumped into the petroleum reservoir. |
| Application rate(s) and frequency | Application Rate: 50 to 1 000 g glutaraldehyde per m3 produced water. Number and timing of application: Batch treatment: Batches may occur up to three times per week in severe cases, but typically occur once per week. Continuous treatment: biocide is supplied in a continuous fashion during operations. |
| Category(ies) of users | Industrial Trained professional |
| Pack sizes and packaging material | — Pails: 25L nominal, material of construction is high density polyethylene. — Drums: 220L nominal, material of construction is high density polyethylene. — IBC (intermediate bulk container): 1 000 L nominal, material of construction is high density polyethylene. — Bulk tank truck: 28 MT max. gross weight, material of construction is stainless steel. — Bulk ISO tank: 20 MT max. gross weight, material of construction is stainless steel. — Offshore-suitable drums: 200L, material of construction is high density polyethylene. — Offshore-suitable semi-bulk containers: 1 000 L, material of construction is stainless steel. — Offshore-suitable containers: 500 IG (2 273 L), material of construction is stainless steel. — Offshore-suitable containers: 1 000 IG (4 546 L), material of construction is stainless steel. |
4.19.1. Use-specific instructions for use
Dose 50 to 1 000 g glutaraldehyde per m3 produced water.
The dose and frequency strongly depend on the formulation and intended use of the matrix to which the preservative is added. Therefore, the user shall determine dosage requirements for their specific matrix/system to be preserved. The lowest effective dose shall be used. If needed, consult the authorisation holder of the preservative product.
4.19.2. Use-specific risk mitigation measures
If discharged into seawater 0,2 mg/L glutaraldehyde must not be exceeded in the produced water for recycling. This concentration can be achieved either by slow release and/or long retention times resulting in degradation of glutaraldehyde and/or by dilution and/or by addition of sodium bisulphite at pH 5 (release after at least 20 minutes) or addition of sodium hydroxide to pH 12 (release after at least 10-16 hours) as degradation aids. Produced water for recycling containing up to 750 mg/L glutaraldehyde can be used for re-injection. Run lab test to determine the soiling dependent dosage and degradation rate in use.
When applied onshore, preserved fluids must be recycled or disposed of as hazardous waste. If release to the sewer is unavoidable, the concentration shall not exceed 1 mg glutaraldehyde/L.
4.19.3. 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.
4.19.4. Where specific to the use, the instructions for safe disposal of the product and its packaging
See general directions for use.
4.19.5. 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.
5. GENERAL DIRECTIONS FOR USE OF THE META SPC 3
5.1. Instructions for use
See use specific instructions for use.
5.2. Risk mitigation measures
Disconnecting the product container manually:
The use of eye protection (chemical goggles) consistent with EN 166 or equivalent during handling of the product is mandatory.
Wear a protective coverall [type 3or type 4] consistent with EN 14605 or equivalent.
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory. Providing at least a powered air purifying respirator with helmet/hood/mask (TH3 (EN 12941or equivalent)/TM3 (EN 12942 or equivalent)), or a full-face mask (EN 136 or equivalent) with particle filter P3 (EN 12083 or equivalent).
During tank cleaning & maintenance:
Wear a protective coverall [type 3or type 4] consistent with EN 14605 or equivalent.
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory. Providing at least a powered air purifying respirator with helmet/hood/mask (TH1 (EN 12941 or equivalent)/TM1 (EN 12942 or equivalent)), a half/quarter mask (EN 140 or equivalent) or a full-face mask (EN 136 or equivalent) with particle filter P2 (EN 12083 or equivalent) each or a filtering half mask (FFP2, EN 149 or equivalent).
Draining, cleaning and maintenance of closed re-circulating system:
Wear a protective coverall [type 3or type 4] consistent with EN 14605 or equivalent.
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
Loading/unloading slurry tanks:
Wear protective chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent during product handling phase (glove material to be specified by the authorisation holder within the product information).
The product must be poured using an automated dosing system.
Ensure that application is carried out in well-ventilated areas.
Use engineering controls to maintain airborne level below exposure limit requirements or guidelines.
Use an approved air-purifying or positive-pressure supplied-air respirator depending on the potential airborne concentration.
Regarding the personal protective equipment listed in this section, 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 references to this act and the European Standards.
5.3. Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing.
If symptoms: Immediately call 112/ambulance for medical assistance.
IF SWALLOWED: If conscious, immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112/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 skin irritation or rash occur: Get medical advice.
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.
Information to Healthcare personnel/doctor:
Immediately initiate life support measures, thereafter call a POISON CENTRE.
Environmental precautions: Prevent from entering into soil, ditches, sewers, waterways and/or groundwater. Spills or discharge to natural waterways is likely to kill aquatic organisms.
Personal precautions, protective equipment and emergency procedures in case of accidental release measures: Evacuate area. Keep upwind of spill. Ventilate area of leak or spill. Only trained and properly protected personnel must be involved in clean-up operations. Use appropriate safety equipment.
Methods and materials for containment and cleaning up: Avoid making contact with spilled material, since glutaraldehyde will be absorbed by most shoes. When cleaning up a spill always wear the appropriate protective equipment, including respiratory protection, gloves, protective clothing and eye protection. A self-contained breathing apparatus or respirator and absorbents may be necessary, depending on the size of the spill and the adequacy of ventilation.
Small spills: Wear the correct protective equipment including gloves and protective clothing and cover the liquid with absorbent material. Collect and seal the material and the dirt that has absorbed the spilled material in polyethylene bags and place in a drum for transit to an approved disposal site. Rinse away the remaining spilled material with water to reduce odour, and discharge the rinsate into a municipal or industrial sewer, not into a natural waterway.
Large spills: In case of nasal and respiratory irritation, vacate the room immediately. Personnel cleaning up should be trained and equipped with a self-contained breathing apparatus, or an officially approved or certified full-face respirator equipped with an organic vapor cartridge, glove, and clothing impervious to glutaraldehyde, including rubber boots or shoe protection. Deactivate with sodium bisulfite (2-3 parts (by weight) per part of glutaraldehyde), collect the neutralized liquid and place in a drum for transit to an approved disposal site.
5.4. Instructions for safe disposal of the product and its packaging
The biocidal product, when being disposed of in its unused and uncontaminated state should be treated as a hazardous waste according to EC Directive 2008/98/EC.
Deactivate with sodium bisulfite (2-3 parts (by weight) per part of glutaraldehyde), collect the neutralized liquid and place in a drum for transit to an approved disposal site. If the concentration of glutaraldehyde is up to 2%, deactivate by the addition of aqueous sodium hydroxide solution in an amount sufficient to maintain a pH of 12 for 8 h, followed by neutralization (i.e. neutral pH) with the careful addition of an inorganic acid e.g. hydrochloric acid, before disposal by appropriate means. Any disposal practices must be in compliance with all national and provincial laws and any municipal or local by-laws governing hazardous waste. Do not dump into any sewers, on the ground, or into any body of water. Avoid release to the environment. High-temperature incineration is an acceptable practice glutaraldehyde burns cleanly to carbon dioxide and water.
Containers used to store glutaraldehyde solutions are non refillable. Do not reuse or refill the containers. Containers should be triple or pressure rinsed with water promptly after they are emptied. They can then be offered for recycling or reconditioning for biocidal products, or they can be punctured and disposed of in a sanitary landfill or by other procedures approved by national and local authorities. Send waste liquid from rinsing of used containers to an approved waste handling facility.
5.5. Conditions of storage and shelf-life of the product under normal conditions of storage
Do not store in and avoid contact with aluminum, carbon steel, copper, mild steel, iron. Avoid contact with amines, ammonia, strong acids, strong bases, strong oxidizers.
Store at temperatures <40 °C
Shelf life:
meta SPC GA 13.5: 12 months in HDPE and stainless steel
6. OTHER INFORMATION
The full titles of the EN standards referenced in the Risk mitigation measures are:
EN ISO 374 – Protective gloves against dangerous chemicals and micro-organisms
EN 166 – Eye protection against chemicals.
EN 14605 – Protective clothing against liquid chemicals – Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4]).
EN 12941 - Respiratory protective devices - Powered filtering devices incorporating a loose fitting respiratory interface - Requirements, testing, marking
EN 12942 – Respiratory protective devices - Powered filtering devices incorporating full face masks, half masks or quarter masks - Requirements, testing, marking
EN 136 - Respiratory protective devices. Full face masks. Requirements, testing, marking
EN 140 - Respiratory protective devices - Half masks and quarter masks - Requirements, testing, marking
EN 149 - Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking
EN 12083 - Respiratory protective devices – Filters with breathing hoses, (Non-mask mounted filters) – Particle filters, gas filters, and combined filters – Requirements, testing, marking
Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
With respect to the “Category (ies) of users” note: “Professionals (including industrial users) means trained professionals if this is required by national legislation.
7. THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3
7.1. Trade name(s), authorisation number and specific composition of each individual product
| Trade name(s) | Trade name(s) | Trade name(s) | SolenisTM IS2544 MICROBIOCIDE | SolenisTM IS2544 MICROBIOCIDE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | AQUCAR(TM) GA 135 Water Treatment Microbiocide | AQUCAR(TM) GA 135 Water Treatment Microbiocide | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Preventol® GA 135 | Preventol® GA 135 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | SANIPOL® PG 135 | SANIPOL® PG 135 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Biosperse™ 2544 MICROBIOCIDE | Biosperse™ 2544 MICROBIOCIDE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Dab 423 | Dab 423 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Ferrocid® 4507 | Ferrocid® 4507 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | GABOTEC G 13.5% B | GABOTEC G 13.5% B | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | GABOTEC G 13.5% B6 | GABOTEC G 13.5% B6 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | GLUT-ACTIVE 13,5 IOB | GLUT-ACTIVE 13,5 IOB | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | GLUT-ACTIVE 13,5-A IOB | GLUT-ACTIVE 13,5-A IOB | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | GLUT-ACTIVE 13,5-B IOB | GLUT-ACTIVE 13,5-B IOB | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | HYDREX 7519 | HYDREX 7519 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | SANITER 422 | SANITER 422 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Spectrum™ RX7813 MICROBIOCIDE | Spectrum™ RX7813 MICROBIOCIDE | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Warosit 249 | Warosit 249 | Market area: EU | Market area: EU | Market area: EU |
| Trade name(s) | Trade name(s) | Trade name(s) | Warostat 3249 | Warostat 3249 | Market area: EU | Market area: EU | Market area: EU |
| Authorisation number | Authorisation number | Authorisation number | EU-0030162-0003 1-3 | EU-0030162-0003 1-3 | EU-0030162-0003 1-3 | ||
| Common name | IUPAC name | Function | Function | CAS number | CAS number | EC number | Content (%) |
| Glutaraldehyde | 1,5-pentanedial | Active substance | Active substance | 111-30-8 | 111-30-8 | 203-856-5 | 13,6 % (w/w) |
ELI: http://data.europa.eu/eli/reg_impl/2025/1906/oj
ISSN 1977-0677 (electronic edition)
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