Commission Implementing Regulation (EU) 2026/1337 of 17 June 2026 granting a Union authorisation for the biocidal product family Ecolab Glut Family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2026-06-17
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, market approval, preservative, storage








L_202601337EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2026/1337


18.6.2026







            COMMISSION IMPLEMENTING REGULATION (EU) 2026/1337
of 17 June 2026
         
granting a Union authorisation for the biocidal product family ‘Ecolab Glut 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 26 September 2016, Ecolab Deutschland GmbH 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 ‘Ecolab Glut Family’ of product-types 6, 11 and 12, 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-VT027129-08 in the Register for Biocidal Products.












(2)


‘Ecolab Glut Family’ contains glutaraldehyde 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 6, 11 and 12.












(3)


On 14 March 2025, 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 1 October 2025, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Ecolab Glut Family’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.












(5)


The opinion concludes that ‘Ecolab Glut 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.












(6)


Glutaraldehyde was identified as a candidate for substitution by Commission Implementing Regulation (EU) 2015/1759 (3), which established that the substance meets the conditions set out in Article 10(1) of Regulation (EU) No 528/2012. Therefore, the evaluating competent authority performed a comparative assessment of the biocidal product in accordance with Article 23(1) of Regulation (EU) No 528/2012. That comparative assessment did not demonstrate that the making available on the market or the use of the ‘Ecolab Glut Family’ should be prohibited or restricted for the uses specified in the application for Union authorisation. That conclusion is based on several factors. First, there is a lack of other adequate authorised biocidal products. Second, no authorised biocidal products offer a combination of modes of action for a given use that would present a significantly lower overall risk to human health, animal health, or the environment, while still being sufficiently effective and without causing significant economic or practical disadvantages. Finally, the chemical diversity of the active substances is not adequate to minimise the occurrence of resistance in the target harmful organism. Therefore, ‘Ecolab Glut Family’ should be authorised for a period not exceeding 5 years in accordance with Article 23(6) of Regulation (EU) No 528/2012.












(7)


On 16 October 2025, 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.












(8)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘Ecolab Glut Family’.












(9)


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-0035830-0000 is hereby granted to Ecolab Deutschland GmbH for the making available on the market and use of the biocidal product family ‘Ecolab Glut Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 8 July 2026 until 30 June 2031.


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 June 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 11 September 2025 on the Union authorisation of ‘Ecolab Glut Family’ (ECHA/BPC/497/2025), https://echa.europa.eu/opinions-on-union-authorisation.

(3)  Commission Implementing Regulation (EU) 2015/1759 of 28 September 2015 approving glutaraldehyde as an existing active substance for use in biocidal products for product-types 2, 3, 4, 6, 11 and 12 (OJ L 257, 2.10.2015, p. 19, ELI: http://data.europa.eu/eli/reg_impl/2015/1759/oj).




ANNEX
Summary of product characteristics for a biocidal product family
Ecolab Glut Family

Product type(s)

PT06: Preservatives for products during storage
PT11: Preservatives for liquid-cooling and processing systems
PT12: Slimicides

Authorisation number EU-0035830-0000

R4BP asset number EU-0035830-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


Ecolab Glut Family




1.2.   Product type(s)







Product type(s)


PT06: Preservatives for products during storage
PT11: Preservatives for liquid-cooling and processing systems
PT12: Slimicides




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Ecolab Deutschland GmbH




Address


Ecolab Allee 1 40789 Monheim am Rhein Germany




Authorisation number


 


EU-0035830-0000





R4BP asset number



 


EU-0035830-0000




Date of the authorisation


 


8 July 2026




Expiry date of the authorisation


 


30 June 2031




1.4.   Manufacturer(s) of the product







Name of manufacturer


Ecolab Limited




Address of manufacturer


Brunel Way, Baglan Energy Park SA11 2GA Neath United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Ecolab Limited site 1 Brunel Way, Baglan Energy Park SA11 2GA Neath United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


Laboratoires Prodene Klint




Address of manufacturer


Rue Denis Papin, 2, Z.I. Mitry Compans F-77290 Mitry-Mory France




Location of manufacturing sites


Laboratoires Prodene Klint site 1 Rue Denis Papin, 2, Z.I. Mitry Compans F-77290 Mitry-Mory France













Name of manufacturer


Ecolab Leeds




Address of manufacturer


Lotherton Way, Garforth LS25 2JY Leeds United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Ecolab Leeds site 1 Lotherton Way, Garforth LS25 2JY Leeds United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


Nalco Deutschland Manufacturing GmbH und Co.KG




Address of manufacturer


Justus-von-Liebig-Str. 11 D-64584 Biebesheim Germany




Location of manufacturing sites


Nalco Deutschland Manufacturing GmbH und Co.KG site 1 Justus-von-Liebig-Str. 11 D-64584 Biebesheim Germany













Name of manufacturer


Ecolab Weavergate




Address of manufacturer


WINNINGTON AVENUE CW8 3AA NORTHWICH, CHESHIRE United Kingdom of Great Britain and Northern Ireland (the)




Location of manufacturing sites


Ecolab Weavergate site 1 WINNINGTON AVENUE CW8 3AA NORTHWICH, CHESHIRE United Kingdom of Great Britain and Northern Ireland (the)













Name of manufacturer


Ecolab Mullingar




Address of manufacturer


Forest Park Zone C Mullingar Ind. Estate Mullingar, Co. Westmeath Ireland




Location of manufacturing sites


Ecolab Mullingar site 1 Forest Park Zone C Mullingar Ind. Estate Mullingar, Co. Westmeath Ireland













Name of manufacturer


Ecolab d.o.o.




Address of manufacturer


Vajngerlova 4 2000 Maribor Slovenia




Location of manufacturing sites


Ecolab d.o.o. site 1 Vajngerlova 4 2000 Maribor Slovenia













Name of manufacturer


Ecolab Rozzano, Italy




Address of manufacturer


VIA GRANDI 9/11 20089 ROZZANO (MI) Italy




Location of manufacturing sites


Ecolab Rozzano, Italy site 1 VIA GRANDI 9/11 20089 ROZZANO (MI) Italy













Name of manufacturer


Ecolab B.V.B.A




Address of manufacturer


Havenlaan: 4 3980 Tessenderlo Belgium




Location of manufacturing sites


Ecolab B.V.B.A site 1 Havenlaan: 4 3980 Tessenderlo Belgium













Name of manufacturer


Nalco Española Manufacturing, SLU




Address of manufacturer


C/Tramuntana s/n, Polígono Industrial de Celrà 17460 CELRÀ (Girona) Spain




Location of manufacturing sites


Nalco Española Manufacturing, SLU site 1 C/Tramuntana s/n, Polígono Industrial de Celrà 17460 CELRÀ (Girona) Spain













Name of manufacturer


Ecolab Production France SAS




Address of manufacturer


BP509, Avenue de Général Patton 51006 Châlons-en-Champagne France




Location of manufacturing sites


Ecolab Production France SAS site 1 BP509, Avenue de Général Patton 51006 Châlons-en-Champagne France













Name of manufacturer


Ecolab Mandra, Greece




Address of manufacturer


25km Old National Road Athens-Theve Mandra Attica Greece




Location of manufacturing sites


Ecolab Mandra, Greece site 1 25km Old National Road Athens-Theve Mandra Attica Greece













Name of manufacturer


NALCO FINLAND MANUFACTURING OY




Address of manufacturer


Kivikummuntie 1 FIN-07955 Tesjoki Finland




Location of manufacturing sites


NALCO FINLAND MANUFACTURING OY site 1 Kivikummuntie 1 FIN-07955 Tesjoki Finland




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







Active substance


Glutaraldehyde




Name of manufacturer


BASF SE




Address of manufacturer


Carl-Bosch-Str. 38 67056 Ludwigshafen Germany




Location of manufacturing sites


BASF SE site 1 Carl-Bosch-Str. 38 67056 Ludwigshafen Germany













Active substance


Glutaraldehyde




Name of manufacturer


Lanxess Corporation




Address of manufacturer


Route 25 25112 Institute, West Virginia United States (the)




Location of manufacturing sites


Lanxess Corporation site 1 Route 25 25112 Institute, West Virginia United States (the)




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 (%)




Glutaraldehyde


 


Active substance


111-30-8


203-856-5


24 - 50 % (w/w)




2.2.   Type(s) of formulation







Formulation type(s)


AL Any other liquid




PART II

SECOND INFORMATION LEVEL META SPC(S)

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier







Identifier


Meta SPC 1




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


PT06: Preservatives for products during storage
PT11: Preservatives for liquid-cooling and processing systems
PT12: Slimicides




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 (%)




Glutaraldehyde


 


Active substance


111-30-8


203-856-5


24 - 24 % (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


H314: Causes severe skin burns and eye damage.
H317: May cause an allergic skin reaction.
H334: May cause allergy or asthma symptoms or breathing difficulties IF INHALED.
H412: Harmful to aquatic life with long lasting effects.
H302: Harmful IF SWALLOWED.
H331: Toxic IF INHALED.
EUH071: Corrosive to the respiratory tract.




Precautionary statements


P260: Do not breathe 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.
P272: Contaminated work clothing should not be allowed out of the workplace.
P273: Avoid release to the environment.
P280: Wear gloves/protective clothing/eye protection/face protection.
P284: [In case of inadequate ventilation] wear respiratory 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].
P304+P340: IF INHALED: Remove person to fresh air and keep comfortable for breathing.
P342+P311: If experiencing respiratory symptoms: Call a POISON CENTER/doctor/....
P305+P351+P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
P363: Wash contaminated clothing before reuse.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P405: Store locked up.
P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Preservation of detergents and cleaning fluids and raw materials thereof







Product type


PT06: Preservatives for products during storage




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Common name: bacteria
Common name: yeasts
Common name: fungi




Field(s) of use


indoor use
Preservation of water-based surfactants detergents and cleaning fluids such as (but not limited to) laundry products, laundry softener, liquid dishwashing products, hard surface cleaners and raw materials for use in detergent and cleaning applications and other uses of defoamers, degreasers and surfactants in for paper, leather and textile and other industries




Application method(s)


Method: single addition to containers and vessels
Detailed description:
Single dose of product to the chemical mixture in vessels or added to drums, canisters etc. via pumps and dosing lines during manufacture.




Application rate(s) and frequency


Application Rate: For preventive use against bacteria until opening: 25-979 mg/kg a.s. (100 – 3 916  mg of product/kg matrix) For preventive use against bacteria in short term preservation (2-6 weeks): 50-979 mg/kg a.s. (200-1 958  mg of product/kg matrix) For curative use against Bacteria & Yeasts: 62,5-979 mg/kg a.s. with a contact time of 48 hours (250 – 3 916  mg of product/kg matrix). Fungi: 500-979 mg/kg a.s. with a contact time of 3 days (2 000  – 3 916  mg of product/kg matrix)
Number and timing of application:
Single application




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg High Density Polyethylene (HDPE) drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE Intermediate Bulk Containers (IBCs)




4.1.1.   Use-specific instructions for use

For the control of bacteria, yeasts and fungi responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.1.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures. See section 6 for the full reference to European standards and Council Directive.
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

Please refer to the general directions for use.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to the 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

Please refer to the general directions for use.
4.2.   Use description


Table 2


Preservation of wax and polymer emulsions and raw materials thereof







Product type


PT06: Preservatives for products during storage




Target organism(s) (including development stage)


Common name: bacteria
Common name: yeasts
Common name: fungi




Field(s) of use


indoor use
outdoor use
Preservative for water-based polymer emulsions (for instance polishes, car polishes, water repellents, wax emulsions and waxes)




Application method(s)


Method: Single addition to containers and vessels
Detailed description:
Single dose of product to the chemical mixture in vessels or added to drums, canisters etc. via pumps and dosing lines during manufacture




Application rate(s) and frequency


Application Rate: For preventive use against bacteria until opening: 25-979 mg/kg a.s. (100-3 916  mg of product/kg matrix) For preventive use against bacteria in short term preservation (2-6 weeks): 50-979 mg/kg a.s. (200-3 916  mg of product/kg matrix) For curative use against: Bacteria & yeasts: 62,5- 979 mg/kg a.s. with a contact time of 48 hours; (250-3 916  mg of product/kg matrix). Fungi: 500-979 mg/kg a.s. with a contact time of 3 days (2 000 -3 916  mg of product/kg)
Number and timing of application:
Single application




Category(ies) of users


industrial
professional




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.2.1.   Use-specific instructions for use

For the control of bacteria, yeasts and fungi responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.2.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
Re-entry is only permitted once the air concentration of the a.s. has dropped below the reference value [AEC inhalation of 0.0106 mg/m3].
See section 6 for the full reference to European standards and Council Directive.
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

Please refer to General directions for use.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.3.   Use description


Table 3


Preservation of water-based products used in the paper industry







Product type


PT06: Preservatives for products during storage




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Common name: bacteria
Common name: yeasts
Common name: fungi




Field(s) of use


indoor use
Preservation of water-based additives for the production of paper (For instance inorganic slurries, detergents, organic dispersions, polymers, pigments, inks, cellulose, starch, glues and their raw materials and pulp).
Preservation of on-site made preparations or additives such as inorganic slurries or dyes solutions being used in the wet-end of paper machines.




Application method(s)


Method: Single addition to containers and vessels
Detailed description:
Single dose of product to the chemical mixture in vessels or added to drums, canisters etc. via pumps and dosing lines during manufacture.




Application rate(s) and frequency


Application Rate: For preventive use against bacteria until opening: 25-979 mg/kg a.s. (100-3 916  mg of product/kg matrix) For preventive use against bacteria in short term preservation (2-6 weeks): 10-979 mg/kg a.s. (40-3 961  mg of product/kg matrix) For curative use against Bacteria, yeasts 62,5-979 mg/kg a.s. with a contact time of 2 days. (250-3 916  mg of product/kg matrix). Fungi: 500-979 mg/kg a.s. with a contact time of 7 days. (2 000 -3 916  mg of product/kg matrix)
Number and timing of application:
One time dosage




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.3.1.   Use-specific instructions for use

For the control of bacteria, yeasts and fungi responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.3.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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:
Handling of undiluted product:
For all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
Handling of preserved product:
Products must not be used for direct preservation of aqueous pulp mixtures (cellulose and additives) intended to be placed on the market for use in systems without automatic pumping and maintenance cleaning processes.
If not used in systems with automatic pumping and maintenance cleaning processes:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).




See section 6 for the full reference to European standards and Council Directive.
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

Please refer to General directions for use
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use
4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use
4.4.   Use description


Table 4


Preservation of paints and raw materials thereof







Product type


PT06: Preservatives for products during storage




Target organism(s) (including development stage)


Common name: bacteria
Common name: yeasts
Common name: fungi




Field(s) of use


indoor use
outdoor use
Preservation of paints and coatings and raw materials for the production of paints, plastic, construction materials and glues (for instance pigments, polymer and pigment dispersions, and inorganic slurries used as fillers)




Application method(s)


Method: Single addition to containers and vessels
Detailed description:
Single dose of product to the chemical mixture in vessels or added to drums, canisters etc. via pumps and dosing lines during manufacture.




Application rate(s) and frequency


Application Rate: For preventive use against bacteria until opening: 25-979 mg/kg a.s. (100-3 916  mg of product/kg matrix) For preventive use against bacteria in short term preservation (2-6 weeks): 10-979 mg/kg a.s. (40-3 916  mg of product/kg matrix) Curative use against; Bacteria, yeasts: 25-979 mg/kg a.s. with a contact time of 7 days, (100-3 916  mg of product/kg matrix) Fungi: 500-979 mg/kg a.s. with a contact time of 7 days (2 000 -3 916  mg of product/kg matrix)
Number and timing of application:
One time dosage




Category(ies) of users


industrial
professional




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.4.1.   Use-specific instructions for use

For the control of bacteria, yeasts and fungi responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.4.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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:
Handling undiluted product:
For all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
The product must not be added to paints and coatings which are applied by spraying.
See section 6 for the full reference to European standards and Council Directive.
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

Please refer to General directions for use.
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.5.   Use description


Table 5


Preservation of auxiliaries used in leather and textile industry







Product type


PT06: Preservatives for products during storage




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Common name: bacteria
Common name: yeasts
Common name: fungi




Field(s) of use


indoor use
Preservation of additives for the production of leather and textile e.g. leather re-fattening agents, pigment and polymer dispersions.




Application method(s)


Method: Single addition to containers and vessels
Detailed description:
Single dose of product to the chemical mixture in vessels or added to drums, canisters etc. via pumps and dosing lines during manufacture.




Application rate(s) and frequency


Application Rate: For preventive use against bacteria until opening: 25-979 mg/kg a.s. (100-3 916  mg of product/kg matrix) For preventive use against bacteria in short term preservation (2-6 weeks): 50-979 mg/kg a.s. (200-3 916  mg of product/kg matrix) For curative use against bacteria and yeasts : 62,5-979 mg/kg a.s. with a contact time of 2 days. (250-3 916  mg of product/kg matrix). Fungi: 500-979 mg/kg a.s. with a contact time of 7 days. (2 000 -3 916  mg of product/kg matrix)
Number and timing of application:
One time dosage




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.5.1.   Use-specific instructions for use

For the control of bacteria, yeasts and fungi responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.5.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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:
Handling of undiluted product:
For all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
Handling of preserved product:
Products must not be used for preservation of leather/textile additives intended for uses where wet hides or wet textiles are not handled automatically and where for waste water treatment industry standards according to BAT are not met.
If not used in automated closed system:






—


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 use of protective coveralls (at least type 3, EN 14605, coveralls material to be specified by the authorisation holder within the product information) when handling wet hides or wet textiles is recommended.
See section 6 for the full reference to European standards and Council Directive.
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

Please refer to General directions for use.
4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.5.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.6.   Use description


Table 6


Preservation of liquid-cooling and processing systems







Product type


PT11: Preservatives for liquid-cooling and processing systems




Target organism(s) (including development stage)


Common name: bacteria
Common name: Legionella - pneumophila




Field(s) of use


indoor use
outdoor use
Prevention of microbial growth in cooling water in recirculating systems (maximum blowdown flowrate 2 m3/h) which may affect process efficiency (heat exchange), materials degradation, filter plugging, and hygiene conditions.




Application method(s)


Method: Regular addition to the water system
Detailed description:
slug doses of product to the water system via automated pumps and dosing lines




Application rate(s) and frequency


Application Rate: For closed system: For curative use against bacteria and Legionella sp.: 24-250 mg/l a.s. (100-1 000  mg of product/l) with a contact time of 1 hour for bacteria and 3 hours for Legionella sp. For preventive use against bacteria and Legionella sp.: 50-250 mg/l a.s (208-1 000  mg of product/l) For small open recirculating system: For curative use against bacteria and Legionella sp.: 24-50 mg/l a.s. (100-208 mg of product/l) with a contact time of 1 hour for bacteria and 3 hours for Legionella sp. For preventive use against bacteria and Legionella sp.: 50 mg/l a.s (208 mg of product/l)
Number and timing of application:
For closed system: 1 dose per day
For small open recirculating system: 1-3 doses per week




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.6.1.   Use-specific instructions for use

For the control of bacteria responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.6.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures must be considered by preference (personal protection measures shall not be permanent measures).
Application of the product is restricted to cooling systems with a maximum blow down flowrate of 2 m3/h. Wastewater must be discharged to the municipal sewer, purified in an on-site industrial sewage treatment plant including a biological treatment step, or directly to surface water via a settling pond that allows a minimum hydraulic retention time of 105 days. The flow rate of the receiving freshwater body must be sufficient to achieve a dilution of at least 200 times.
The interval between the last dose and system drainage should be at least 36 hrs.
See section 6 for the full reference to European standards and Council Directive.
4.6.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to General directions for use.
4.6.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.6.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.7.   Use description


Table 7


Preservation of hydrotesting fluids in offshore oil field applications







Product type


PT11: Preservatives for liquid-cooling and processing systems




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Common name: bacteria




Field(s) of use


outdoor use
offshore
Preservation of hydrotesting fluids in offshore oil field applications to prevent microbially induced deterioration and corrosion.




Application method(s)


Method: Single addition to the testing water
Detailed description:
Single dose of product to the testing water via automated pumps and dosing lines.




Application rate(s) and frequency


Application Rate: For curative use: 12,5-2 000  mg/l a.s. (50-8 000  mg of product/l) with a contact time of 4 hours.
Number and timing of application:
One time dosage




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.7.1.   Use-specific instructions for use

For the control of bacteria for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.7.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
Wear chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent for connecting/disconnecting intermediate bulk containers (glove material to be specified by the authorisation holder within the product information).
If discharged into seawater 0,2 mg/L glutaraldehyde must not be exceeded in the hydrotesting fluid. This concentration can be achieved either by slow release and/or long retention times resulting in sufficient degradation of glutaraldehyde and/orby dilution with unpolluted wate, and/or by addition of sodium bisulphite at pH 5 (release after at least 20 minutes) or sodium hydroxide to pH 12 (release after at least 10-16 hours) as degradation aids. Hydrotesting water 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.
If small volumes have to be disposed of or if it is not possible to reduce the concentration to 0,2 mg/l, the fluid can be released to seawater directly by reducing the blowdown rate to allow sufficient dilution in seawater. The required reduction is locational and depends strongly on e.g. flow velocity.
To avoid the development of resistance: in addition to the requirements in the general instructions for use, check the efficacy of the product on site.
If needed, causes of reduced efficacy must be investigated to ensure that there is no resistance or to identify potential resistance.
See section 6 for the full reference to European standards and Council Directive.
4.7.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to General directions for use.
4.7.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.7.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.8.   Use description


Table 8


Preservation of production and injection water in offshore oilfield applications







Product type


PT11: Preservatives for liquid-cooling and processing systems




Target organism(s) (including development stage)


Common name: bacteria




Field(s) of use


outdoor use
offshore
(Produced) Water (re-) injection systems in water treatment units, in the produced water system, in gas/crude production, transmission and storage systems, and during pipeline pigging and scraping operations to prevent microbially induced deterioration and corrosion.




Application method(s)


Method: Addition to vessels, tanks, pipelines etc.
Detailed description:
Addition of product to the water phases via automated pumps and dosing lines.




Application rate(s) and frequency


Application Rate: • 12,5-750 mg a.s./L water (50-3 000  mg of product/l water) • for direct preservation of produced water discharged: 12,5-130 mg a.s./l water (50-520 mg of product/l water)
Number and timing of application:
For injection water and production water re-injection, pipeline and storage tank uses:






—


Add 50-3 000  mg of 24% glutaraldehyde solution per liter water (0,001-0,075% a.s) once per week with a dosing time of 1-6 hours or










—


50-3 000  mg of 24% glutaraldehyde solution per liter water daily over 2 hours.










—


Dose rate max. 3 000  mg/l of 24% glutaraldehyde solution per liter water daily with a dosing time of 1 hour or










—


max. 3 000  mg/l of 24% glutaraldehyde solution weekly with a dosing time of 2 hours or










—


max. 2 400  mg/l of 24% glutaraldehyde solution every two weeks for 6 hours




or other dosing regimens resulting in same or lower daily average concentrations.






—


For produced water intended to be disposed to the sea:






—


dose min. 50 mg/l - max. 72 mg/l 24% glutaraldehyde solution daily with a dosing time of 2 hours or










—


50 mg/l – max. 520 mg/l 24% glutaraldehyde solution weekly with a dosing time of two hours








or other dosing regimens resulting in the same or lower daily average concentrations.
Contact time of minimun 24 hours should be observed before discharge.




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.8.1.   Use-specific instructions for use

For the control of bacteria responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.8.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
Wear chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent for connecting/disconnecting intermediate bulk containers (glove material to be specified by the authorisation holder within the product information).
If discharged into seawater 0,2 mg/L glutaraldehyde must not be exceeded in the produced water. 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 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.
See section 6 for the full reference to European standards and Council Directive.
4.8.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to General directions for use.
4.8.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.8.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.9.   Use description


Table 9


Slimicide for hydrotesting fluids in offshore oilfield applications







Product type


PT12: Slimicides




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Common name: bacteria




Field(s) of use


outdoor use
offshore
To avoid microbially induced corrosion and spoilage by destroying biofilm in pipelines, vessels, boilers etc. during pressure tests after construction or maintenance.




Application method(s)


Method: Single addition to the testing water
Detailed description:
Single dose of product to the testing water via automated pumps and dosing lines




Application rate(s) and frequency


Application Rate: For curative use: 12,5-2 000  mg a.s./l water. (50-8 000  mg of product/l water)
Number and timing of application:
Single addition to the fluids, allow a minimal contact time of 24 hours (shut-in) before discharge.




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.9.1.   Use-specific instructions for use

For the control of bacteria for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.9.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
Wear chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent for connecting/disconnecting intermediate bulk containers (glove material to be specified by the authorisation holder within the product information).
If discharged into seawater 0,2 mg/L glutaraldehyde must not be exceeded in the hydrotesting fluid. This concentration can be achieved either by slow release and/or long retention times resulting in sufficient degradation of glutaraldehyde and/or by dilution with unpolluted water, and/or by addition of sodium bisulphite at pH 5 (release after at least 20 minutes) or sodium hydroxide to pH 12 (release after at least 10-16 hours) as degradation aids. Hydrotesting water 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.
If small volumes have to be disposed of or if it is not possible to reduce the concentration to 0,2 mg/l, the fluid can be released to seawater directly by reducing the blowdown rate to allow sufficient dilution in seawater. The required reduction is locational and depends strongly on e.g. flow velocity.
To avoid the development of resistance: in addition to the requirements in the general instructions for use, check the efficacy of the product on site.
If needed, causes of reduced efficacy must be investigated to ensure that there is no resistance or to identify potential resistance.
See section 6 for the full reference to European standards and Council Directive.
4.9.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to General directions for use.
4.9.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.9.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.10.   Use description


Table 10


Slimicide for production and injection water in offshore oilfield applications







Product type


PT12: Slimicides




Target organism(s) (including development stage)


Common name: bacteria




Field(s) of use


outdoor use
offshore
To avoid microbially induced corrosion and spoilage by destroying biofilm in (produced) water (re–)injection systems in water treatment units, in the produced water system, in gas/crude production, transmission and storage systems and during pipeline pigging and scraping operations.




Application method(s)


Method: Single addition to the testing water
Detailed description:
Single dose of product to the testing water via automated pumps and dosing lines




Application rate(s) and frequency


Application Rate: • 12,5-750 mg a.s./l water (50-3 000  mg of product/l water) • for direct preservation of produced water discharged: 12,5-130 mg a.s./l water (50-520 mg of product/l water)
Number and timing of application:
For injection water and production water re-injection, pipeline and storage tank uses:






—


Add 50-3 000  mg of 24% glutaraldehyde solution per liter water (0,001-0,075% a.s.) once per week with a dosing time of 1-6 hours or










—


50-3 000  mg of 24% glutaraldehyde solution per liter water daily over 2 hours.










—


Dose rate max. 3 000  mg/l 24% glutaraldehyde solution per liter water daily with a dosing time of 1 hour or










—


max. 3 000  mg/l 24% glutaraldehyde solution weekly with a dosing time of 2 hours or










—


max. 2 400  mg/l 24% glutaraldehyde solution every two weeks for 6 hours




or other dosing regimens resulting in same or lower daily average concentrations.






—


For produced water intended to be disposed to the sea:






—


dose min. 50 mg/l - max. 72 mg/l of 24% glutaraldehyde solution daily with a dosing time of 2 hours or










—


50 mg/l – max 520 mg/l of 24% glutaraldehyde solution weekly with a dosing time of two hours








or other dosing regimens resulting in the same or lower daily average concentrations.
Contact time of minimum 24 hours should be observed before discharge.




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.10.1.   Use-specific instructions for use

For the control of bacteria responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.10.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
Wear chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent for connecting/disconnecting intermediate bulk containers (glove material to be specified by the authorisation holder within the product information).
If discharged into seawater 0,2 mg/L glutaraldehyde must not be exceeded in the produced water. 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 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.
See section 6 for the full reference to European standards and Council Directive.
4.10.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to General directions for use.
4.10.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.10.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.11.   Use description


Table 11


Slimicide for paper industry, wet end







Product type


PT12: Slimicides




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Common name: bacteria
Common name: fungi




Field(s) of use


indoor use
For use as paper slimicide during continuous paper production, for slime control/prevention in process water and for short term protection of wet stock during machine shut down.




Application method(s)


Method: Addition to vessels, tanks, circuits etc.
Detailed description:
Automatic addition of product into the white water circuit, head box or machine chest via pumps and dosing lines.




Application rate(s) and frequency


Application Rate: • For curative use by shock dose: bacteria: 15-200 mg a.s./l (60-800 mg of product/l) Contact time: 3 hours fungi: 100-200 mg a.s./l (400-800 mg of product/l) Contact time: 24 hours • For preventive use by intermittent dosage against bacteria: 15-150 mg a.s./l (60-600 mg of product)
Number and timing of application:
Single dosage over 1 hour or repeat every 6-8 hours (intermittent dosage)




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.11.1.   Use-specific instructions for use

For the control of bacteria and fungi responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.11.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
If not used in systems with automatic pumping and maintenance cleaning processes:
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).






—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).




Ensure low level of containment.
Application is only allowed in paper factories that comply with the Industrial Emission Directive 2010/75/EU where wastewater is purified in an on-site industrial sewage treatment plant including a biological treatment step in accordance to the Best Available Techniques (BAT) as prescribed in the BAT-reference document (BREF) for the production of pulp, paper and board. The effluent must be diluted at least 200 times. Paper factories that are exempted from the Industrial Emission Directive must discharge their waste water to the municipal sewer.
To avoid the development of resistance: in addition to the requirements in the general instructions for use, check the efficacy of the product on site. If needed, causes of reduced efficacy must be investigated to ensure that there is no resistance or to identify potential resistance.
See section 6 for the full reference to European standards and Council Directive.
4.11.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to General directions for use.
4.11.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.11.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.12.   Use description


Table 12


Slimicide for paper industry, paper de-inking







Product type


PT12: Slimicides




Target organism(s) (including development stage)


Common name: bacteria
Common name: fungi




Field(s) of use


indoor use
The control of slime and microbial release of catalase enzyme interfering with the de-inking process during paper recycling.




Application method(s)


Method: Addition to vessels, tanks, circuits etc.
Detailed description:
Automatic addition of product into the white water circuit, head box or machine chest via pumps and dosing lines




Application rate(s) and frequency


Application Rate: For preventive use against bacteria: 15-125 mg a.s./l water (60-500 mg of product/l) For curative use against bacteria and fungi: shock dose as bactericide: 15-125 mg a.s./l water (60-500 mg of product/l) with a contact time of 3 hours. shock dose as fungicide: 100-125 mg a.s/l water (400-500 mg of product/l) with a contact time of 24 hours.
Number and timing of application:
up to 4 times per day lasting 30 minutes




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.12.1.   Use-specific instructions for use

For the control of bacteria and fungi responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.12.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
If not used in systems with automatic pumping and maintenance cleaning processes:
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).






—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).




Application is only allowed in paper factories that comply with the Industrial Emission Directive 2010/75/EU where wastewater is purified in an on-site industrial sewage treatment plant including a biological treatment step in accordance to the Best Available Techniques (BAT) as prescribed in the BAT-reference document (BREF) for the production of pulp, paper and board. The effluent must be diluted at least 200 times. Paper factories that are exempted from the Industrial Emission Directive must discharge their waste water to the municipal sewer.
To avoid the development of resistance: in addition to the requirements in the general instructions for use, check the efficacy of the product on site. If needed, causes of reduced efficacy must be investigated to ensure that there is no resistance or to identify potential resistance.
See section 6 for the full reference to European standards and Council Directive.
4.12.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to General directions for use.
4.12.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.12.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 1

5.1.   Instructions for use

See Use-specific instructions for use per use
5.2.   Risk mitigation measures

See Use-specific risk mitigation measures per use
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Likely direct or indirect effects may include: Skin and eye contact: Irritation to severe burns of the skin and eyes. May induce eye lacrimation, skin sensitization and/or allergic dermatitis. Mouth contact/ingestion: Irritation to corrosion of the gastrointestinal tract. May include nausea, vomiting, ulceration of the esophagus and/or stomach with subsequent perforation, hematemesis and/or internal bleeding. Inhalation/aspiration: Irritation to corrosion of the respiratory tract. May include coughing, rhinitis, coryza, epistaxis, pulmonary oedema, bronchospasm, respiratory distress and/ or asthma. Other clinical manifestations may include; headache, tachycardia, palpitations, hypotension and depression of the CNS.
First aid
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Immediately call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
Initiate life support measures if needed, thereafter call a POISON CENTRE.
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.
5.4.   Instructions for safe disposal of the product and its packaging

Incinerate in suitable incineration plant, observing local authority regulations. Contaminated packaging should be emptied as far as possible; then it can be passed on for recycling after being thoroughly cleaned.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store in a well ventilated place. Keep container tightly closed.
Keep at temperature not exceeding 40°C.
Shelf-life: 24 months
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) connections, including items providing protection to parts of the body only (Types PB [3]).
EN 14387 - Respiratory protective devices – Gas filter(s) and combined filter(s) - 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 1

7.1.   Trade name(s), authorisation number and specific composition of each individual product













Trade name(s)


NALCO 73500


 




Authorisation number


 


EU-0035830-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Glutaraldehyde


 


Active substance


111-30-8


203-856-5


24 % (w/w)




7.2.   Trade name(s), authorisation number and specific composition of each individual product













Trade name(s)


NALCO WT-407


 




Authorisation number


 


EU-0035830-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Glutaraldehyde


 


Active substance


111-30-8


203-856-5


24 % (w/w)




1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier







Identifier


Meta SPC 2




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


PT06: Preservatives for products during storage
PT11: Preservatives for liquid-cooling and processing systems
PT12: Slimicides




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 (%)




Glutaraldehyde


 


Active substance


111-30-8


203-856-5


50 - 50 % (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


H301: Toxic IF SWALLOWED.
H330: Fatal IF INHALED.
H314: Causes severe skin burns and eye damage.
H334: May cause allergy or asthma symptoms or breathing difficulties IF INHALED.
H317: May cause an allergic skin reaction.
H410: Very toxic to aquatic life with long lasting effects.
EUH071: Corrosive to the respiratory tract.




Precautionary statements


P260: Do not breathe 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.
P272: Contaminated work clothing should not be allowed out of the workplace.
P273: Avoid release to the environment.
P280: Wear gloves/protective clothing/eye protection/face protection.
P284: [In case of inadequate ventilation] wear respiratory 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].
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.
P363: Wash contaminated clothing before reuse.
P391: Collect spillage.
P403+P233: Store in a well-ventilated place. Keep container tightly closed.
P405: Store locked up.
P501: Dispose of contents to a hazardous waste disposal service in accordance with the statutory regulations.
P501: Dispose of container to a hazardous waste disposal service in accordance with the statutory regulations.




4.   AUTHORISED USE(S) OF THE META SPC

4.1.   Use description


Table 1


Preservation of detergents and cleaning fluids and raw materials thereof







Product type


PT06: Preservatives for products during storage




Target organism(s) (including development stage)


Common name: bacteria
Common name: yeasts
Common name: fungi




Field(s) of use


indoor use
Preservation of water-based surfactants, detergents and cleaning fluids such as (but not limited to) laundry products, laundry softener, liquid dishwashing products, hard surface cleaners and raw materials for use in detergent and cleaning applications and other uses of defoamers, degreasers and surfactants in for paper, leather and textile and other industries




Application method(s)


Method: single addition to containers and vessels
Detailed description:
Single dose of product to the chemical mixture in vessels or added to drums, canisters etc. via pumps and dosing lines during manufacture.




Application rate(s) and frequency


Application Rate: For preventive use against bacteria until opening: 25-979 mg/kg a.s. (50-1 958  mg of product/kg matrix) For preventive use against bacteria in short term preservation (2-6 weeks): 50-979 mg/kg a.s. (100-1 958  mg of product/kg matrix) For curative use against; Bacteria & Yeasts: 62,5-979 mg/kg a.s. with a contact time of 2 days. (125-1 958  mg of product/kg matrix). Fungi: 500-979 mg/kg a.s. with a contact time of 3 days. (1 000 -1 958  mg of product/kg matrix)
Number and timing of application:
Single application




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.1.1.   Use-specific instructions for use

For the control of bacteria, yeasts and fungi responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.1.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
See section 6 for the full reference to European standards and Council Directive.
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

Please refer to General directions for use.
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to 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

Please refer to General directions for use.
4.2.   Use description


Table 2


Preservation of wax and polymer emulsions and raw materials thereof







Product type


PT06: Preservatives for products during storage




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Common name: bacteria
Common name: yeasts
Common name: fungi




Field(s) of use


indoor use
outdoor use
Preservative for water-based polymer emulsions (for instance polishes, car polishes, water repellents, wax emulsions and waxes)




Application method(s)


Method: Single addition to containers and vessels
Detailed description:
Single dose of product to the chemical mixture in vessels or added to drums, canisters etc. via pumps and dosing lines during manufacture




Application rate(s) and frequency


Application Rate: For preventive use against bacteria until opening: 25-979 mg/kg a.s. (50-1 958  mg of product/kg matrix) For preventive use against bacteria in short term preservation (2-6 weeks): 50-979 mg/kg a.s. (100-1 958  mg of product/kg matrix) For curative use against: bacteria & yeasts: 62,5- 979 mg/kg a.s. with a contact time of 48 hours. (125-1 958  mg of product/kg matrix). Fungi: 500-979 mg/kg a.s. with a contact time of 3 days (1 000 -1 958  mg of product/kg)
Number and timing of application:
Single application




Category(ies) of users


industrial
professional




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.2.1.   Use-specific instructions for use

For the control of bacteria, yeasts and fungi responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.2.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
Re-entry is only permitted once the air concentration of the a.s. has dropped below the reference value [AEC inhalation of 0.0106 mg/m3].
See section 6 for the full reference to European standards and Council Directive.
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

Please refer to General directions for use.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.2.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.3.   Use description


Table 3


Preservation of water-based products used in the paper industry







Product type


PT06: Preservatives for products during storage




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Common name: bacteria
Common name: yeasts
Common name: fungi




Field(s) of use


indoor use
Preservation of water-based additives for the production of paper (For instance inorganic slurries, detergents, organic dispersions, polymers, pigments, inks, cellulose, starch, glues and their raw materials and pulp)
Preservation of on-site made preparations or additives such as inorganic slurries or dyes solutions being used in the wet-end of paper machines.




Application method(s)


Method: Single addition to containers and vessels
Detailed description:
Single dose of product to the chemical mixture in vessels or added to drums, canisters etc. via pumps and dosing lines during manufacture




Application rate(s) and frequency


Application Rate: For preventive use against bacteria until opening: 25-979 mg/kg a.s. (50-1 958  mg of product/kg matrix) For preventive use against bacteria in short term preservation (2-6 weeks): 10-979 mg/kg a.s. (20-1 958  mg of product/kg matrix) For curative use against bacteria, yeasts 62,5-979 mg/kg a.s. with a contact time of 2 days. (125-1 958  mg of product/kg matrix). Fungi: 500-979 mg a.s./kg with a contact time of 7 days (1 000 -1 958  mg of product/kg matrix)
Number and timing of application:
One time dosage




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.3.1.   Use-specific instructions for use

For the control of bacteria, yeasts and fungi responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.3.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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:
Handling of undiluted product:
For all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures must be considered by preference (personal protection measures shall not be permanent measures).
Handling of preserved product:
Products must not be used for direct preservation of aqueous pulp mixtures (cellulose and additives) intended to be placed on the market for use in systems without automatic pumping and maintenance cleaning processes.
If not used in systems with automatic pumping and maintenance cleaning processes:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).




See section 6 for the full reference to European standards and Council Directive.
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

Please refer to General directions for use.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.3.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.4.   Use description


Table 4


Preservation of paints and raw materials thereof







Product type


PT06: Preservatives for products during storage




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Common name: bacteria
Common name: yeasts
Common name: fungi




Field(s) of use


indoor use
outdoor use
Preservation of paints and coatings and raw materials for the production of paints, plastic and glues (for instance pigments, polymer and pigment dispersions, and inorganic slurries used as fillers)




Application method(s)


Method: Single addition to containers and vessels
Detailed description:
Single dose of product to the chemical mixture in vessels or added to drums, canisters etc. via pumps and dosing lines during manufacture




Application rate(s) and frequency


Application Rate: For preventive use against bacteria until opening: 25-979 mg/kg a.s. (50-1 958  mg of product/kg matrix) For preventive use against bacteria in short term preservation (2-6 weeks): 10-979 mg/kg a.s. (20-1 958  mg of product/kg matrix) Curative use against Bacteria, yeasts: 25-979 mg/kg a.s. with a contact time of 7 days, (50-1 958  mg of product/kg matrix). Fungi: 500-979 mg/kg a.s. with a contact time of 7 days (1 000 -1 958  mg of product/kg matrix)
Number and timing of application:
One time dosage




Category(ies) of users


industrial
professional




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.4.1.   Use-specific instructions for use

For the control of bacteria, yeasts and fungi responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.4.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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:
Handling of undiluted product:
For all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
The product must not be added to paints and coatings which are applied by spraying.
See section 6 for the full reference to European standards and Council Directive.
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

Please refer to General directions for use.
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.4.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.5.   Use description


Table 5


Preservation of auxiliaries used in leather and textile industry







Product type


PT06: Preservatives for products during storage




Target organism(s) (including development stage)


Common name: bacteria
Common name: yeasts
Common name: fungi




Field(s) of use


indoor use
Preservation of additives for the production of leather and textile e.g. leather re-fattening agents, pigment and polymer dispersions.




Application method(s)


Method: Single addition to containers and vessels
Detailed description:
Single dose of product to the chemical mixture in vessels or added to drums, canisters etc. via pumps and dosing lines during manufacture




Application rate(s) and frequency


Application Rate: For preventive use against bacteria: 25-979 mg/kg a.s. (50-1 958  mg of product/kg matrix) For preventive use against bacteria in short term preservation (2-6 weeks): 50-979 mg/kg a.s. (100-1 958  mg of product/kg matrix) For curative use against bacteria and yeasts : 62,5-979 mg/kg a.s. with a contact time of 2 days. (125-1 958  mg of product/kg matrix). Fungi: 500-979 mg/kg a.s. with a contact time of 7 days. (1 000 -1 958  mg of product/kg matrix)
Number and timing of application:
One time dosage




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.5.1.   Use-specific instructions for use

For the control of bacteria, yeasts and fungi responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.5.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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:
Handling of undiluted product:
For all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
Handling of preserved product:
Products must not be used for preservation of leather/textile additives intended for uses where wet hides or wet textiles are not handled automatically and where for waste water treatment industry standards according to BAT are not met.
If not used in automated closed system:






—


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 use of protective coveralls (at least type 3, EN 14605, coveralls material to be specified by the authorisation holder within the product information) when handling wet hides or wet textiles is recommended.
See section 6 for the full reference to European standards and Council Directive.
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

Please refer to General directions for use.
4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.5.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.6.   Use description


Table 6


Preservation of water in liquid-cooling and processing systems







Product type


PT11: Preservatives for liquid-cooling and processing systems




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Common name: bacteria
Common name: Legionella - pneumophila




Field(s) of use


indoor use
outdoor use
Prevention of microbial growth in cooling water in recirculating systems (maximum blowdown flowrate 2 m3/h) which may affect process efficiency (heat exchange), materials degradation, filter plugging, and hygiene conditions.




Application method(s)


Method: Regular addition to the water system
Detailed description:
Slug doses of product to the water system via automated pumps and dosing lines




Application rate(s) and frequency


Application Rate: For closed system: For curative use against bacteria and Legionella sp.: 24-250 mg/l a.s. (48-500 of mg product /l) with a contact time of 1 hour for bacteria and 3 hours for Legionella sp. For preventive use against bacteria and Legionella sp.: 50-250 mg/l a.s(100-500 mg of product/l) For small open recirculating system: For curative use against bacteria and Legionella sp.: 24-50 mg/l a.s. (48-100 mg of product/l) with a contact time of 1 hour for bacteria and 3 hours for Legionella sp. For preventive use against bacteria and Legionella sp.: 50 mg/l a.s (100 mg of product/l)
Number and timing of application:
For closed system: Maximum frequency 1 dose per day
For small open recirculating system: 1-3 doses per week




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.6.1.   Use-specific instructions for use

For the control of bacteria responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.6.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
Application of the product is restricted to cooling systems with a maximum blow down flowrate of 2 m3/h. Waste water must be discharged to the municipal sewer, purified in an on-site industrial sewage treatment plant including a biological treatment step, or directly to surface water via a settling pond that allows a minimum hydraulic retention time of 105 days. The flow rate of the receiving fresh water body must be sufficient to achieve a dilution of at least 200 times.
The interval between the last dose and system drainage should be at least 36 hrs.
See section 6 for the full reference to European standards and Council Directive.
4.6.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to General directions for use.
4.6.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.6.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.7.   Use description


Table 7


Preservation of hydrotesting fluids in offshore oil field applications







Product type


PT11: Preservatives for liquid-cooling and processing systems




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Common name: bacteria




Field(s) of use


outdoor use
offshore
Preservation of hydrotesting fluids in oil field applications to prevent microbially induced deterioration and corrosion.




Application method(s)


Method: Single addition to the testing water
Detailed description:
Single dose of product to the testing water via automated pumps and dosing lines




Application rate(s) and frequency


Application Rate: For curative use: 12,5-2 000  mg/l a.s. (25-4 000  mg of product/l) with a contact time of 4 hours.
Number and timing of application:
One time dosage




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.7.1.   Use-specific instructions for use

For the control of bacteria for spoilage, deterioration, gas evolution, odour, pH/viscosity changes, disintegration of formulations and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.7.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
Wear chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent for connecting/disconnecting intermediate bulk containers (glove material to be specified by the authorisation holder within the product information).
If discharged into seawater 0,2 mg/L glutaraldehyde must not be exceeded in the hydrotesting fluid. This concentration can be achieved either by slow release and/or long retention times resulting in sufficient degradation of glutaraldehyde and/orby dilution with unpolluted wate, and/or by addition of sodium bisulphite at pH 5 (release after at least 20 minutes) or sodium hydroxide to pH 12 (release after at least 10-16 hours) as degradation aids. Hydrotesting water 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.
If small volumes have to be disposed of or if it is not possible to reduce the concentration to 0,2 mg/l, the fluid can be released to seawater directly by reducing the blowdown rate to allow sufficient dilution in seawater. The required reduction is locational and depends strongly on e.g. flow velocity.
To avoid the development of resistance: in addition to the requirements in the general instructions for use, check the efficacy of the product on site.
If needed, causes of reduced efficacy must be investigated to ensure that there is no resistance or to identify potential resistance.
See section 6 for the full reference to European standards and Council Directive.
4.7.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to General directions for use.
4.7.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging
Please refer to General directions for use.
4.7.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.8.   Use description


Table 8


Preservation of production and injection water in offshore oilfield applications







Product type


PT11: Preservatives for liquid-cooling and processing systems




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Common name: bacteria




Field(s) of use


outdoor use
offshore
(Produced) Water (re-) injection systems in water treatment units, in the produced water system, in gas/crude production, transmission and storage systems, and during pipeline pigging and scraping operations to prevent microbially induced deterioration and corrosion




Application method(s)


Method: Addition to vessels, tanks, pipelines etc
Detailed description:






—


addition of product to the water phases via automated pumps and dosing lines








Application rate(s) and frequency


Application Rate: • 12,5-750 mg a.s./l water (25-1500 mg of product/l water) • for direct preservation of produced water discharged: 12,5-130 mg a.s./l water (25-260 mg of product/l water)
Number and timing of application:






—


For injection water and production water re-injection, pipeline and storage tank uses:






—


Add 25-1500 mg of 50% glutaraldehyde solution per liter water (0,001-0,075% a.s.) once per week with a dosing time of 1-6 hours or










—


25-1500 mg of 50% glutaraldehyde solution per liter water daily over 2 hours.










—


Dose rate max. 1 500  mg/l of 50% glutaraldehyde solution per liter water daily with a dosing time of 1 hour or










—


max. 1 500  mg/l of 50% glutaraldehyde solution weekly with a dosing time of 2 hours or










—


max. 1 200  mg/l of 50% glutaraldehyde solution every two weeks for 6 hours




or other dosing regimens resulting in same or lower daily average concentrations.










—


For produced water intended to be disposed to the sea:






—


dose min. 25 mg/l - max. 36 mg/l of 50% glutaraldehyde solution daily with a dosing time of 2 hours or










—


25 mg/l – max 260 mg/l of 50 % glutaraldehyde solution weekly with a dosing time of two hours




or other dosing regimens resulting in the same or lower daily average concentrations.




Contact time of minimum 24 hours should be observed before discharge.




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.8.1.   Use-specific instructions for use

For the control of bacteria responsible for spoilage, deterioration, gas evolution, odour, pH/viscosity changes, disintegration of formulations, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the matrix and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.8.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
Wear chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent for connecting/disconnecting intermediate bulk containers (glove material to be specified by the authorisation holder within the product information).
If discharged into seawater 0,2 mg/L glutaraldehyde must not be exceeded in the produced water. 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 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.
See section 6 for the full reference to European standards and Council Directive.
4.8.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to General directions for use.
4.8.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.8.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.9.   Use description


Table 9


Slimicide for hydrotesting fluids in offshore oilfield applications







Product type


PT12: Slimicides




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Common name: bacteria




Field(s) of use


outdoor use
offshore
To avoid microbially induced corrosion and spoilage by destroying biofilm in pipelines, vessels, boilers etc. during pressure tests after construction or maintenance




Application method(s)


Method: Single addition to the testing water
Detailed description:
Single dose of product to the testing water via automated pumps and dosing lines




Application rate(s) and frequency


Application Rate: For curative use: 12,5-2 000  mg a.s/l water (25-4 000  mg of product/l water).
Number and timing of application:
Single addition to the fluids, allow a minimal contact time of 24 hours (shut-in) before discharge.




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.9.1.   Use-specific instructions for use

For the control of bacteria for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.9.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
Wear chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent for connecting/disconnecting intermediate bulk containers (glove material to be specified by the authorisation holder within the product information).
If discharged into seawater 0,2 mg/L glutaraldehyde must not be exceeded in the hydrotesting fluid. This concentration can be achieved either by slow release and/or long retention times resulting in sufficient degradation of glutaraldehyde and/or by dilution with unpolluted water, and/or by addition of sodium bisulphite at pH 5 (release after at least 20 minutes) or sodium hydroxide to pH 12 (release after at least 10-16 hours) as degradation aids. Hydrotesting water 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.
If small volumes have to be disposed of or if it is not possible to reduce the concentration to 0,2 mg/l, the fluid can be released to seawater directly by reducing the blowdown rate to allow sufficient dilution in seawater. The required reduction is locational and depends strongly on e.g. flow velocity.
To avoid the development of resistance: in addition to the requirements in the general instructions for use, check the efficacy of the product on site.
If needed, causes of reduced efficacy must be investigated to ensure that there is no resistance or to identify potential resistance.
See section 6 for the full reference to European standards and Council Directive.
4.9.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to General directions for use.
4.9.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.9.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.10.   Use description


Table 10


Slimicide for production and injection water in offshore oilfield applications







Product type


PT12: Slimicides




Target organism(s) (including development stage)


Common name: bacteria




Field(s) of use


outdoor use
offshore
To avoid microbially induced corrosion and spoilage by destroying biofilm in (produced) water (re–)injection systems in water treatment units, in the produced water system, in gas/crude production, transmission and storage systems and during pipeline pigging and scraping operations.




Application method(s)


Method: Single addition to the testing water
Detailed description:






—


single dose of product to the testing water via automated pumps and dosing lines








Application rate(s) and frequency


Application Rate: • 12,5-750 mg a.s/l water (25-1500 mg of product/l water) • for direct preservation of produced water discharged: 12,5-130 mg a.s./l water (25-260 mg of product/l water)
Number and timing of application:






—


For injection water and production water re-injection, pipeline and storage tank uses:






—


Add 25-1500 mg of 50% glutaraldehyde solution per liter water (0,001-0,075% a.s.) once per week with a dosing time of 1-6 hours or










—


25-1500 mg 50% glutaraldehyde solution per liter water daily over 2 hours.










—


Dose rate max. 1 500  mg/l 50% glutaraldehyde solution per liter water daily with a dosing time of 1 hour or










—


max. 1 500  mg/l 50% glutaraldehyde solution weekly with a dosing time of 2 hours or










—


max. 1 200  mg/l 50% glutaraldehyde solution every two weeks for 6 hours




or other dosing regimens resulting in same or lower daily average concentrations.










—


For produced water intended to be disposed to the sea:






—


dose min. 25 mg/l - max. 36 mg/l 50% glutaraldehyde solution daily with a dosing time of 2 hours or










—


25 mg/l – max 260 mg/l 50% glutaraldehyde solution weekly with a dosing time of two hours




or other dosing regimens resulting in the same or lower daily average concentrations.




Contact time of minimum 24 hours should be observed before discharge.




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.10.1.   Use-specific instructions for use

For the control of bacteria responsible for spoilage, deterioration, gas evolution, odour, pH/viscosity changes, disintegration of formulations, slime, and corrosion. The product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.10.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
Wear chemical resistant gloves meeting the requirements of European Standard EN 374 or equivalent for connecting/disconnecting intermediate bulk containers (glove material to be specified by the authorisation holder within the product information).
If discharged into seawater 0,2 mg/L glutaraldehyde must not be exceeded in the produced water. 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 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.
See section 6 for the full reference to European standards and Council Directive.
4.10.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to General directions for use.
4.10.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.10.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.11.   Use description


Table 11


Slimicide for paper industry, wet end







Product type


PT12: Slimicides




Target organism(s) (including development stage)


Common name: bacteria
Common name: fungi




Field(s) of use


indoor use
For use as paper slimicide during continuous paper production, for slime control/prevention in process water and for short term protection of wet stock during machine shut down.




Application method(s)


Method: Addition to vessels, tanks, circuits etc.
Detailed description:
Automatic addition of product into the white water circuit, head box or machine chest via pumps and dosing lines




Application rate(s) and frequency


Application Rate: • For curative use by shock dose: bacteria: 15-200 mg a.s./l (30-400 mg of product/l) Contact time: 3 hours fungi: 100-200 mg a.s./l (200-400 mg of product/l) Contact time: 24 hours • For preventive use by intermittent dosage against bacteria: 15-150 mg a.s./l (30-300 mg of product/l)
Number and timing of application:
Single dosage over 1 hour or repeat every 6-8 hours (intermittent dosage)




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.11.1.   Use-specific instructions for use

For the control of bacteria and fungi responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally. The lowest effective dose should be used.
4.11.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
If not used in systems with automatic pumping and maintenance cleaning processes:
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).






—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).




Ensure low level of containment.
Application is only allowed in paper factories that comply with the Industrial Emission Directive 2010/75/EU where wastewater is purified in an on-site industrial sewage treatment plant including a biological treatment step in accordance to the Best Available Techniques (BAT) as prescribed in the BAT-reference document (BREF) for the production of pulp, paper and board. The effluent must be diluted at least 200 times. Paper factories that are exempted from the Industrial Emission Directive must discharge their wastewater to the municipal sewer.
To avoid the development of resistance: in addition to the requirements in the general instructions for use, check the efficacy of the product on site. If needed, causes of reduced efficacy must be investigated to ensure that there is no resistance or to identify potential resistance.
See section 6 for the full reference to European standards and Council Directive.
4.11.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to General directions for use.
4.11.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.11.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
4.12.   Use description


Table 12


Slimicide for paper industry, paper de-inking







Product type


PT12: Slimicides




Where relevant, an exact description of the authorised use


 




Target organism(s) (including development stage)


Common name: bacteria
Common name: fungi




Field(s) of use


indoor use
The control of slime and microbial release of catalase enzyme interfering with the de-inking process during paper recycling.




Application method(s)


Method: Addition to vessels, tanks, circuits etc.
Detailed description:
Automatic addition of product into the white water circuit, head box or machine chest via pumps and dosing lines




Application rate(s) and frequency


Application Rate: For preventive use against bacteria: 15-125 mg a.s./l water (30-250 mg of product/l) For curative use against bacteria and fungi: shock dose as bactericide: 15-125 mg a.s./l water (30-250 mg of product/l) with a contact time of 3 hours. shock dose as fungicide: 100-125 mg a.s./l water (200-250 mg of product/l) with a contact time of 24 hours.
Number and timing of application:
up to 4 times per day lasting 30 minutes




Category(ies) of users


industrial




Pack sizes and packaging material


230-500 kg HDPE drums
20-100 kg HDPE pails
50-60 kg stainless steel/HPDE inliner drums
1 000 -2 000  kg HDPE IBCs




4.12.1.   Use-specific instructions for use

For the control of bacteria and fungi responsible for spoilage, deterioration, gas evolution, odour, colour/pH/viscosity changes, disintegration of formulations, slime, and corrosion. Product should be added directly to the water phase where adequate mixing will ensure quick dissolution. In hot process, allow the temperature to fall below 40 °C prior to addition.
The dose strongly depends on the formulation and intended use of the matrix to which the preservative is added. Therefore, consult the manufacturer of the preservative product, to determine the dosage requirements for the specific matrix to be preserved or determine the dosage experimentally.
4.12.2.   Use-specific risk mitigation measures

The following personal protective equipment is mandatory. 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 all procedures where undiluted biocidal product is openly handled (such as mixing and loading, entering pumps into drums, repairing pumps or connecting lines) the following risk mitigation measures must be followed, unless they can be replaced by technical and/or organisational measures:






—


Use of respiratory protective equipment (RPE) providing a protection factor of at least 10 according to EN 14387 or equivalent is mandatory. At least a powered air purifying respirator with helmet/hood/mask (TH1/TM1), or a full mask with combination filter gas/P2 is required (filter Type A/ Type A-P2) to be specified by the authorisation holder within the product information). The user must be trained in the correct use of the prescribed RPE.










—


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).










—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).










—


The use of eye protection according to EN 166 or equivalent or face protection during handling of the product is mandatory.










—


Wear suitable protective footwear against chemicals according to EN 13832 or equivalent when applying the product.




Technical and organisational protection measures have to be considered by preference (personal protection measures shall not be permanent measures).
If not used in systems with automatic pumping and maintenance cleaning processes:
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).






—


Wear a protective coverall (at least type 3) according to EN 14605 or equivalent which is impermeable for the biocidal product (coverall material to be specified by the authorisation holder within the product information).




Application is only allowed in paper factories that comply with the Industrial Emission Directive 2010/75/EU where wastewater is purified in an on-site industrial sewage treatment plant including a biological treatment step in accordance to the Best Available Techniques (BAT) as prescribed in the BAT-reference document (BREF) for the production of pulp, paper and board. The effluent must be diluted at least 200 times. Paper factories that are exempted from the Industrial Emission Directive must discharge their waste water to the municipal sewer.
To avoid the development of resistance: in addition to the requirements in the general instructions for use, check the efficacy of the product on site. If needed, causes of reduced efficacy must be investigated to ensure that there is no resistance or to identify potential resistance.
See section 6 for the full reference to European standards and Council Directive.
4.12.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Please refer to General directions for use.
4.12.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

Please refer to General directions for use.
4.12.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

Please refer to General directions for use.
5.   GENERAL DIRECTIONS FOR USE OF THE META SPC 2

5.1.   Instructions for use

See Use-specific instructions for use per use
5.2.   Risk mitigation measures

See Use-specific risk mitigation measures per use
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Likely direct or indirect effects may include: Skin and eye contact: Irritation to severe burns of the skin and eyes. May induce eye lacrimation, skin sensitization and/or allergic dermatitis. Mouth contact/ingestion: Irritation to corrosion of the gastrointestinal tract. May include nausea, vomiting, ulceration of the esophagus and/or stomach with subsequent perforation, hematemesis and/or internal bleeding. Inhalation/aspiration: Irritation to corrosion of the respiratory tract. May include coughing, rhinitis, coryza, epistaxis, pulmonary oedema, bronchospasm, respiratory distress and/ or asthma. Other clinical manifestations may include; headache, tachycardia, palpitations, hypotension and depression of the CNS.
First Aid:
IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Immediately call 112/ambulance for medical assistance.
Information to Healthcare personnel/doctor:
Immediately initiate life support measures if needed, thereafter call a POISON CENTRE.
IF SWALLOWED: If conscious: Immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Keep at rest in a position comfortable for breathing. Call 112 /ambulance for medical assistance.
Information to Healthcare personnel/doctor: Immediately initiate life support measures, 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.
5.4.   Instructions for safe disposal of the product and its packaging

Incinerate in suitable incineration plant, observing local authority regulations. Contaminated packaging should be emptied as far as possible; then it can be passed on for recycling after being thoroughly cleaned.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store in a well ventilated place. Keep container tightly closed.
Keep at temperature not exceeding 40°C.
Shelf-life: 24 months
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) connections, including items providing protection to parts of the body only (Types PB [3]).
EN 14387 - Respiratory protective devices – Gas filter(s) and combined filter(s) - 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 2

7.1.   Trade name(s), authorisation number and specific composition of each individual product













Trade name(s)


Nalco 7634


 




Authorisation number


 


EU-0035830-0003 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Glutaraldehyde


 


Active substance


111-30-8


203-856-5


50 % (w/w)







ELI: http://data.europa.eu/eli/reg_impl/2026/1337/oj
ISSN 1977-0677 (electronic edition)