Commission Implementing Regulation (EU) 2023/753 of 12 April 2023 granting a Union authorisation for the biocidal product family “C(M)IT/MIT formulations” (Text with EEA relevance)
Date: 2023-04-12
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, market approval, preservative








L_2023100EN.01004801.xml










13.4.2023   


EN


Official Journal of the European Union


L 100/48








            COMMISSION IMPLEMENTING REGULATION (EU) 2023/753
of 12 April 2023
         
granting a Union authorisation for the biocidal product family “C(M)IT/MIT formulations”
         
(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 the first subparagraph of Article 44(5) thereof,

Whereas:







(1)


On 26 June 2017, ERM Regulatory Services Limited, acting on behalf of Solenis Switzerland GmbH, submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 and Article 4 of Commission Implementing Regulation (EU) No 414/2013 (2) for authorisation of the same biocidal product family, as referred to in Article 1 of Implementing Regulation (EU) No 414/2013, named “C(M)IT/MIT formulations”, of product-types 6, 11 and 12, as described in Annex V to Regulation (EU) No 528/2012. The application was recorded under case number BC-TY032745-97 in the Register for Biocidal Products. The application also indicated the application number of the related reference product family “CMIT-MIT Aqueous 1.5-15”, recorded in that Register under case number BC-CY032700-28.












(2)


The same biocidal product family “C(M)IT/MIT formulations” contains a mixture of CMIT/MIT, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.












(3)


On 26 January 2021, the Agency submitted to the Commission an opinion (3) and the draft summary of the biocidal product characteristics (‘SPC’) of “C(M)IT/MIT formulations” in accordance with Article 6(1) and (2) of Implementing Regulation (EU) No 414/2013.












(4)


The opinion concludes that “C(M)IT/MIT formulations” is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that the proposed differences between the same biocidal product family and the related reference biocidal product family are limited to information which can be the subject of an administrative change in accordance with Commission Implementing Regulation (EU) No 354/2013 (4), that “C(M)IT/MIT formulations” is eligible for Union authorisation in accordance with Article 42(1) of Regulation (EU) No 528/2012, and that based on the assessment of the related reference “CMIT-MIT Aqueous 1.5-15” product family and subject to compliance with the draft SPC, the same biocidal product family meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012.












(5)


On 30 April 2021, 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.












(6)


The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the same biocidal product family “C(M)IT/MIT formulations”.












(7)


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-0025678-0000 is granted to Solenis Switzerland GmbH for the making available on the market and use of the same biocidal product family “C(M)IT/MIT formulations” in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 3 May 2023 until 31 August 2032.


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, 12 April 2023.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1.

(2)  Commission Implementing Regulation (EU) No 414/2013 of 6 May 2013 specifying a procedure for the authorisation of same biocidal products in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 125, 7.5.2013, p. 4).

(3)  ECHA opinion of 26 January 2021 on the Union authorisation of the same biocidal product family “C(M)IT/MIT formulations”, https://echa.europa.eu/opinions-on-union-authorisation

(4)  Commission Implementing Regulation (EU) No 354/2013 of 18 April 2013 on changes of biocidal products authorised in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 109, 19.4.2013, p. 4).




ANNEX
Summary of product characteristics for a biocidal product family

C(M)IT/MIT formulations


Product type 6 - Preservatives for products during storage (Preservatives)


Product type 11 - Preservatives for liquid-cooling and processing systems (Preservatives)


Product type 12 - Slimicides (Preservatives)


Authorisation number: EU-0025678-0000


R4BP asset number: EU-0025678-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION
1.1.   Family name







Name


C(M)IT/MIT formulations




1.2.   Product type(s)







Product type(s)


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




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Solenis Switzerland GmbH




Address


Mühlentalstrasse 38, 8200 Schaffhausen Switzerland




Authorisation number


EU-0025678-0000





R4BP asset number



EU-0025678-0000




Date of the authorisation


3 May 2023




Expiry date of the authorisation


31 August 2032




1.4.   Manufacturer(s) of the biocidal products







Name of manufacturer


Solenis Switzerland GmbH




Address of manufacturer


Mühlentalstrasse 38, 8200 Schaffhausen Switzerland




Location of manufacturing sites







Fütingsweg 20, D-47805 Krefeld Germany




Wimsey Way, Somercotes, DE55 4LR Alfreton United Kingdom




Högastensgatan 18, 252 32 Helsingborg Sweden




AD International B.V. Markweg Zuid 27, 4793 ZJ Fijnaart Netherlands








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







Active substance


Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)




Name of manufacturer


Specialty Electronic Materials Switzerland GmbH




Address of manufacturer


Bachtobelstrasse 3, 8810 Horgen Switzerland




Location of manufacturing sites


Jiangsu FOPIA Chemicals Co., Ltd, Touzeng Village, 224555 Binhuai Town, Binhai County, Yancheng City, Jiangsu, China
Rohm and Haas (UK) Ltd. Tyneside Works, Ellison Street,, NE32 3DJ Jarrow United Kingdom













Active substance


Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)




Name of manufacturer


Thor GmbH




Address of manufacturer


Landwehrstraße 1, 67346 Speyer Germany




Location of manufacturing sites


Landwehrstraße 1, 67346 Speyer Germany













Active substance


Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)




Name of manufacturer


Thor Quimicos de México, SA de CV




Address of manufacturer


Km 182 Autopista México – Querétaro, Pedro Escobedo, 76700 Querétaro Mexico




Location of manufacturing sites


Km 182 Autopista México – Querétaro, Pedro Escobedo, 76700 Querétaro Mexico













Active substance


Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)




Name of manufacturer


Troy Chemical Company BV




Address of manufacturer


Poortweg 4C, 2612 Delft Netherlands




Location of manufacturing sites







Weifang Heaven-sent New Materials Technology Co. Ltd, Binhai Road, Changyi Coastal Economic Development Zone, 261312 Weifang China




Dalian Xingyuan Chemistry Co., Ltd, Room 1205/1206, Pearl River International Building, No.99, Xinkai Road, Xigang District, Songmudao Chemical Industry Zone, Puwan New District, 116308 Dalian China




Dalian Bio-Chem Company Limited, Songmudao Plant: Songmudao Chemical Industry, Zone, Puwan New District, 116308 Dalian China

















Active substance


Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)




Name of manufacturer


Jiangsu FOPIA Chemicals Co., Ltd




Address of manufacturer


Touzeng Village, Binhuai Town, Binhai County, 224555 Yancheng City China




Location of manufacturing sites


Touzeng Village, Binhuai Town, Binhai County, 224555 Yancheng City China




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 (%)




Min


Max




Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)


 


Active Substance


55965-84-9


 


2,2 


20,9 




2.2.   Type(s) of formulation







Formulation(s)


AL - Any other liquid




PART II

SECOND INFORMATION LEVEL - META SPC(S)


META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 1 identifier







Identifier


Meta SPC 3




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


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




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 (%)




Min


Max




Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)


 


Active Substance


55965-84-9


 


2,2 


6,5 




2.2.   Type(s) of formulation of the meta SPC 1







Formulation(s)


AL - Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1






Hazard statements


Harmful if inhaled.
Causes severe skin burns and eye damage.
May cause an allergic skin reaction.
Very toxic to aquatic life with long lasting effects.
Corrosive to the respiratory tract.
May be corrosive to metals.
Harmful if swallowed.




Precautionary statements


Do not breathe fume.
Wash skin thoroughly after handling.
Do no eat, drink or smoke when using this product.
Contaminated work clothing should not be allowed out of the workplace.
Avoid release to the environment.
Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.
Take off contaminated clothing.And wash it before reuse.
If skin irritation or rash occurs:Get medical advice.
IF SWALLOWED:Rinse mouth.Do NOT induce vomiting.
IF ON SKIN (or hair):Take off immediately all contaminated clothing.Rinse skin with water.
IF INHALED:Remove person to fresh air and keep comfortable for breathing.
Immediately call a POISON CENTER/ doctor.
IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
Collect spillage.
Store locked up.
Keep only in original packaging.
IF SWALLOWED:Call a POISON CENTER/ doctor if you feel unwell.
Store in a corrosion-resistant container with a resistant inner liner.
Absorb spillage to prevent material damage.




4.   AUTHORISED USE(S) OF THE META SPC 1
4.1.   Use description


Table 1


Use # 1 – Preservation of polymer lattices







Product type


PT06 - Preservatives for products during storage (Preservatives)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Fungi
Development stage:




Field(s) of use


Indoor
Preservation of polymer latexes
The biocidal product is recommended for the control of bacteria, yeast and fungi in the manufacture, storage, and transport of latexes, synthetic polymers including Hydrolysed Poly Acryl Amide (HPAM) and biopolymers (e.g. xanthan, dextran..) natural latexes.




Application method(s)


Method: Closed system
Detailed description:
Manual and automated application.
The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.




Application rate(s) and frequency


Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 14,9 - 50 mg /kg of C(M)IT/MIT (3:1) in final product.
Dilution (%): -
Number and timing of application:
The biocidal product is added at single dose at the time of manufacture, storage or shipment.
To ensure uniform distribution, slowly disperse using automated metering or manual addition, into product with agitation. Mix thoroughly until evenly dispersed throughout the product.
Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.
Professional uses
14,9 - 50 mg /kg of C(M)IT/MIT (3:1) in final product.
For the biocidal product as supplied: for industrial use only.




Category(ies) of users


Industrial




Pack sizes and packaging material


For industrial and professional users:






—


HDPE flask: 5 l (nominal)










—


HDPE Pail / Jerrycan: 10 l, 20 l, 25 l, 30 l (nominal)










—


Box with HDPE liner: 20 l










—


HDPE Drum: 110 l, 120 l, 200 l, 260 l










—


HDPE IBC: 650 l, 800 l, 1000 l, 1250 l




All products should be transport and stored in a vented room.




4.1.1.   Use-specific instructions for use







—


The preservative can be added at any stage of the production of the product.










—


Earliest possible addition is recommended for optimal protection.










—


Consult the manufacturer to determine the optimal dosage for the various products to be preserved.










—


It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.










—


The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.










—


The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.




4.1.2.   Use-specific risk mitigation measures







—


During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:






—


Minimisation of manual phases (process automation);










—


Use of a dosing device;










—


Regular cleaning of equipment and work area;










—


Avoidance of contact with contaminated tools and objects;










—


Good standard of general ventilation;










—


Training and management of staff on good practice.














—


PPE is as follows:






—


protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);










—


protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);










—


Eye protection;










—


Substance/task appropriate respirator if ventilation is inadequate.














—


The maximal products concentration used for the preservation of polymer lattices being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:






—


Minimisation of manual phases;










—


Use of a dosing device;










—


Regular cleaning of equipment and work area;










—


Good standard of general ventilation;










—


Training and management of staff on good practice.








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

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

See general directions for use.
4.1.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
4.2.   Use description


Table 2


Use # 2 – Preservation of mineral slurries







Product type


PT06 - Preservatives for products during storage (Preservatives)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:




Field(s) of use


Indoor
Preservation of mineral slurries
The biocidal product is recommended to control the growth of bacteria in aqueous-based inorganic/mineral slurries and inorganic pigments which are formulated into paints, coatings and paper.




Application method(s)


Method: Closed system
Detailed description:
Manual and automated application.
The biocidal product should be dispensed as a tankside additive into the circulating use-dilution of the fluid, using a metering pump or by manual pouring, at a point to assure adequate mixing throughout the system.




Application rate(s) and frequency


Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products; Professional uses: 10- 30 mg/kg of C(M)IT/MIT (3:1) in final product.
Dilution (%): -
Number and timing of application:
The biocidal product is added at single dose at the time of manufacture, storage or shipment.
Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.
Professional uses:
10 - 30 mg/kg of C(M)IT/MIT (3:1) in final product.
For the biocidal product as supplied: for industrial use only.




Category(ies) of users


Industrial




Pack sizes and packaging material


For industrial and professional users:






—


HDPE flask: 5 l (nominal)










—


HDPE Pail / Jerrycan: 10 l, 20 l, 25 l, 30 l (nominal)










—


Box with HDPE liner: 20 l










—


HDPE Drum: 110 l, 120 l, 200 l, 260 l










—


HDPE IBC: 650 l, 800 l, 1000 l, 1250 l




All products should be transport and stored in a vented room.




4.2.1.   Use-specific instructions for use







—


The preservative can be added at any stage of the production of the product.










—


Earliest possible addition is recommended for optimal protection.










—


Consult the manufacturer to determine the optimal dosage for the various products to be preserved.










—


It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.










—


The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.










—


The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.




4.2.2.   Use-specific risk mitigation measures







—


During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:






—


Minimisation of manual phases (process automation);










—


Use of a dosing device;










—


Regular cleaning of equipment and work area;










—


Avoidance of contact with contaminated tools and objects;










—


Good standard of general ventilation;










—


Training and management of staff on good practice.














—


PPE is as follows:






—


protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);










—


protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);










—


Eye protection;










—


Substance/task appropriate respirator if ventilation is inadequate.














—


The maximal products concentration used for the preservation of mineral slurries being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:






—


Minimisation of manual phases;










—


Use of a dosing device;










—


Regular cleaning of equipment and work area;










—


Good standard of general ventilation;










—


Training and management of staff on good practice.








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

See general directions for use.
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See 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

See general directions for use.
4.3.   Use description


Table 3


Use # 3 – Preservation of functional fluids (hydraulic fluids, antifreeze, corrosion inhibitors, etc. - excluding fuel additives)







Product type


PT06 - Preservatives for products during storage (Preservatives)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:




Field(s) of use


Indoor
Preservation of functional fluids (hydraulic fluids, antifreeze, corrosion inhibitors, etc. - excluding fuel additives)
The biocidal product is recommended to control the growth of bacteria in functional fluids such as brake and hydraulic fluids, antifreeze additives, corrosion inhibitors, spinning fluids. The biocidal product inhibits the growth microorganisms, which would otherwise lead to odours formation, viscosity alteration, discolouration of product and premature product failure.




Application method(s)


Method: Closed system
Detailed description:
Manual and automated dosing.
The biocidal product should be dispensed to the end use fluid at a point to ensure adequate mixing using preferably automated metering pump or by manual addition.




Application rate(s) and frequency


Application Rate: Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products. Professional uses: Add at a typical use rate between 6 to 30 mg C(M)IT/MIT (3:1) per kg final product to be treated.
Dilution (%): -
Number and timing of application:
The biocidal product is added at single dose at time of manufacturing, storage or shipment.
Industrial uses: 1,5 - 14,5 % C(M)IT/MIT in the biocidal products.
Professional uses:
Add at a typical use rate between 6 to 30 mg C(M)IT/MIT (3:1) per kg final product to be treated
For the biocidal product as supplied: for industrial use only.




Category(ies) of users


Industrial




Pack sizes and packaging material


For industrial and professional users:






—


HDPE flask: 5 l (nominal)










—


HDPE Pail / Jerrycan: 10 l, 20 l, 25 l, 30 l (nominal)










—


Box with HDPE liner: 20 l










—


HDPE Drum: 110 l, 120 l, 200 l, 260 l










—


HDPE IBC: 650 l, 800 l, 1000 l, 1250 l




All products should be transport and stored in a vented room.




4.3.1.   Use-specific instructions for use







—


The preservative can be added at any stage of the production of the product.










—


Earliest possible addition is recommended for optimal protection.










—


Consult the manufacturer to determine the optimal dosage for the various products to be preserved.










—


It is recommended that the optimum biocide concentration and compatibility with individual formulations is determined by means of laboratory tests.










—


The duration and storage conditions of the preserved matrices may impact the efficacy of the product, microbiological tests should be conducted to determine the appropriate application rate without exceeding the maximum authorised application rate.










—


The biocidal product shall be used for treatment of products (articles/mixtures) distributed only to professional users.




4.3.2.   Use-specific risk mitigation measures







—


During handling phases of products from Meta SPC 1, 2, 3 and 4 (mixing and loading), exposure to the product (corrosive and skin sensitizer products) has to be limited by use of PPE and application of technical and organisational RMM:






—


Minimisation of manual phases (process automation);










—


Use of a dosing device;










—


Regular cleaning of equipment and work area;










—


Avoidance of contact with contaminated tools and objects;










—


Good standard of general ventilation;










—


Training and management of staff on good practice.














—


PPE is as follows:






—


protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);










—


protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);










—


Eye protection;










—


Substance/task appropriate respirator if ventilation is inadequate.














—


The maximal products concentration used for the preservation of functional fluids (hydraulic fluids, antifreeze, corrosion inhibitors, etc…) being above the threshold value of 15 ppm, exposure has to be limited by use of PPE, protecting skin and mucous membranes potentially exposed, and application of technical and organisational RMM:






—


Minimisation of manual phases;










—


Use of a dosing device;










—


Regular cleaning of equipment and work area;










—


Good standard of general ventilation;










—


Training and management of staff on good practice.








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

See general directions for use.
4.3.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See 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

See general directions for use.
4.4.   Use description


Table 4


Use # 4 – Preservation of liquids used in closed recirculating cooling systems







Product type


PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria (including Legionella pneumophila)
Development stage:
Common name: Yeasts
Development stage:
Common name: Fungi
Development stage:




Field(s) of use


Indoor
Outdoor
Preservation of liquids used in closed recirculating cooling systems (Closed re-circulating cooling water systems comprise compressor cooling, air conditioning chilled water, boilers, engine jacket cooling, power supply cooling, and other industrial processes).
The biocidal product is used to control the growth of aerobes and anaerobes bacteria, yeast, fungi, and biofilm in the circulating water of closed systems




Application method(s)


Method: Closed system
Detailed description:
Manual and automated dosing.




Application rate(s) and frequency


Application Rate: Curative efficacy:- against bacteria (including L. pneumophila) at 5 - 14,9 g C(M)IT/MIT (3:1) / m3 of water. Contact time: 24 hours - against biofilm: 14,9 g C(M)IT/MIT (3:1) / m3 of water. Contact time: 24 hours.- against fungi and yeasts at 1 – 3 g C(M)IT/MIT (3:1) / m3 of water. Contact time: 48 hours. Preventive efficacy:- against bacteria (including L. pneumophila) at 3 – 14,9 g C(M)IT/MIT (3:1) / m3 of water. - against biofilm (including L. pneumophila): 3 g C(M)IT/MIT (3:1) / m3 of water.
Dilution (%): -
Number and timing of application:
Curative efficacy:






—


against bacteria (including L. pneumophila) at 5 - 14,9 g C(M)IT/MIT (3:1) / m3 of water.




Contact time: 24 hours






—


against biofilm: 14,9 g C(M)IT/MIT (3:1) / m3 of water.




Contact time: 24 hours






—


against fungi and yeasts at 1 – 3 g C(M)IT/MIT (3:1) / m3 of water.




Contact time: 48 hours
Preventive efficacy:
against bacteria (including L. pneumophila) at 3 – 14,9 g C(M)IT/MIT (3:1) / m3 of water.
against biofilm (including L. pneumophila): 3 g C(M)IT/MIT (3:1) / m3 of water.




Category(ies) of users


Industrial




Pack sizes and packaging material


For industrial and professional users:






—


HDPE flask: 5 l (nominal)










—


HDPE Pail / Jerrycan: 10 l, 20 l, 25 l, 30 l (nominal)










—


Box with HDPE liner: 20 l










—


HDPE Drum: 110 l, 120 l, 200 l, 260 l










—


HDPE IBC: 650 l, 800 l, 1000 l, 1250 l




All products should be transport and stored in a vented room.




4.4.1.   Use-specific instructions for use

Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.4.2.   Use-specific risk mitigation measures







—


Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.










—


During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:






—


Minimisation of manual phases (process automation);










—


Use of a dosing device;










—


Regular cleaning of equipment and work area;










—


Avoidance of contact with contaminated tools and objects;










—


Good standard of general ventilation;










—


Training and management of staff on good practice.














—


PPE is as follows:






—


protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);










—


protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);










—


Eye protection;










—


Substance/task appropriate respirator if ventilation is inadequate.








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

See general directions for use.
4.4.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See 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

See general directions for use.
4.5.   Use description


Table 5


Use # 5 – Preservation of liquids used in small open recirculating cooling systems







Product type


PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria (including Legionella pneumophila)
Development stage:
Common name: Yeasts
Development stage:
Common name: Fungi
Development stage:
Common name: Algae (green algae and cyanobacteria)
Development stage:




Field(s) of use


Indoor
Outdoor
Preservation of liquids used in small open recirculating cooling systems (blowdown and recirculating flow rates, as well as total volume of water limited to 2 m3/h, and 100 m3/h and 300 m3 respectively)
Process and cooling water: Used to control the growth of bacteria, algae, fungi and biofilm




Application method(s)


Method: Open system
Detailed description:
Manual and automated dosing.




Application rate(s) and frequency


Application Rate: Curative treatment Against bacteria (including L. pneumophila) at 5 – 14,9 g C(M)IT/MIT (3:1) / m3 of water , - against biofilm (including L. pneumophila) at 1,5 to 14,9 g C(M)IT/MIT (3:1) / m3 of water, - against fungi (including yeast) at 1 – 14,9 g C(M)IT/MIT (3:1) / m3 of water. Preventive treatment: - Against bacteria, green algae and cyanobacteria at 3 g C(M)IT/MIT (3:1) / m3 of water, - against biofilm (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m3 of water.
Dilution (%): -
Number and timing of application:
Curative treatment:






—


Against bacteria (including L. pneumophila) at 5 – 14,9 g C(M)IT/MIT (3:1) / m3 of water
Contact time: 24 hours










—


against biofilm (including L. pneumophila) at 1,5 - 14,9 g C(M)IT/MIT (3:1) / m3 of water
Contact time: 48 hours.










—


against fungi and yeast at 1 – 14,9 g C(M)IT/MIT (3:1) / m3 of water
Contact time: 48 hours.




Preventive treatment:






—


against bacteria, green algae and cyanobacteria at 3 g C(M)IT/MIT (3:1) / m3 of water.










—


against biofilm (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m3 of water.








Category(ies) of users


Industrial




Pack sizes and packaging material


For industrial and professional users:






—


HDPE flask: 5 l (nominal)










—


HDPE Pail / Jerrycan: 10 l, 20 l, 25 l, 30 l (nominal)










—


Box with HDPE liner: 20 l










—


HDPE Drum: 110 l, 120 l, 200 l, 260 l










—


HDPE IBC: 650 l, 800 l, 1000 l, 1250 l




All products should be transport and stored in a vented room.




4.5.1.   Use-specific instructions for use

Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.5.2.   Use-specific risk mitigation measures







—


Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.










—


During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:






—


Minimisation of manual phases (process automation);










—


Use of a dosing device;










—


Regular cleaning of equipment and work area;










—


Avoidance of contact with contaminated tools and objects;










—


Good standard of general ventilation;










—


Training and management of staff on good practice.














—


PPE is as follows:






—


protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);










—


protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);










—


Eye protection;










—


Substance/task appropriate respirator if ventilation is inadequate.














—


Cooling fluid must not enter surface water directly. Use product only in premises that are connected to a STP.










—


The product can only be used when the cooling towers are equipped with drift eliminators that reduce the drift at least by 99%.




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

See general directions for use.
4.5.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See 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

See general directions for use.
4.6.   Use description


Table 6


Use # 6 – Preservation of liquids used in pasteurizers, conveyor belts and air washers







Product type


PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria (including Legionella pneumophila)
Development stage:
Common name: Yeasts
Development stage:
Common name: Fungi
Development stage:
Common name: Algae (green algae and cyanobacteria)
Development stage:




Field(s) of use


Indoor
Outdoor
Preservation of liquids used in non-food pasteurizers and conveyor belts, air washers.




Application method(s)


Method: -
Detailed description:
The biocidal product is dosed automatically in the heat transfer fluid, in a place of good mixing (e.g. collecting sump below the conveyor belt). The feeding pipe is used to dose the biocidal product below the water level in order to limit its evaporation.




Application rate(s) and frequency


Application Rate: Curative treatment: -against bacteria (including L. pneumophila): 5 - 14,9 g C(M)IT/MIT (3:1) / m3 of water - against biofilm (including L. pneumophila) at 1,5 - 14,9 g C(M)IT/MIT (3:1) / m3 of water - against fungi and yeast at 1 – 14,9 g C(M)IT/MIT (3:1) / m3 of water. Preventive treatment: Against bacteria, green algae and cyanobacteria at 3 g C(M)IT/MIT (3:1) / m3 of water, against biofilm (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m3 of water.
Dilution (%): -
Number and timing of application:
Curative treatment:






—


against bacteria (including L. pneumophila): 5 - 14,9 g C(M)IT/MIT (3:1) / m3 of water.
Contact time: 24 hours










—


against biofilm (including L. pneumophila) at 1,5 - 14,9 g C(M)IT/MIT (3:1) / m3 of water
Contact time: 48 hours.










—


against fungi and yeast at 1 – 14,9 g C(M)IT/MIT (3:1) / m3 of water
Contact time: 48 hours.




Preventive treatment:






—


Against bacteria, green algae and cyanobacteria at 3 g C(M)IT/MIT (3:1) / m3 of water.










—


against biofilm (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m3 of water.








Category(ies) of users


Industrial




Pack sizes and packaging material


For industrial and professional users:






—


HDPE flask: 5 l (nominal)










—


HDPE Pail / Jerrycan: 10 l, 20 l, 25 l, 30 l (nominal)










—


Box with HDPE liner: 20 l










—


HDPE Drum: 110 l, 120 l, 200 l, 260 l










—


HDPE IBC: 650 l, 800 l, 1000 l, 1250 l




All products should be transport and stored in a vented room.




4.6.1.   Use-specific instructions for use

Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
Air washers: For use only in industrial air-washer systems that maintain effective mist eliminating components.
4.6.2.   Use-specific risk mitigation measures







—


Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.










—


During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:






—


Minimisation of manual phases (process automation);










—


Use of a dosing device;










—


Regular cleaning of equipment and work area;










—


Avoidance of contact with contaminated tools and objects;










—


Good standard of general ventilation;










—


Training and management of staff on good practice.














—


PPE is as follows:






—


protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);










—


protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);










—


Eye protection;










—


Substance/task appropriate respirator if ventilation is inadequate.








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

See general directions for use.
4.6.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See 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

See general directions for use.
4.7.   Use description


Table 7


Use # 7 – Preservation of recirculating fluids used in textile and fiber processing, leather processing, photo-processing and fountain solution systems







Product type


PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:




Field(s) of use


Indoor
Preservation of recirculating fluids used in textile, fiber processing, leather processing, photo-processing and fountain solution systems
C(M)IT/MIT (3:1) biocidal products are used for the preservation of textile and spinning fluids, photo processing solutions, leather process (e.g. washing and soaking treatment stages) and printing fountain solutions to control the integrity of recirculating fluid by reducing microbial contamination in the bulk solution.




Application method(s)


Method: -
Detailed description:
Manual and automated dosing.
The preservation of all end-products is performed in most cases highly automated by industrial users
The biocidal product is added to the central sump, basin or recirculating lines in an area with adequate mixing.




Application rate(s) and frequency


Application Rate: Curative treatment: Against bacteria at 16-30 mg C(M)IT/MIT (3:1) per l of fluid
Dilution (%): -
Number and timing of application:
Curative treatment: Against bacteria at 16-30 mg C(M)IT/MIT (3:1) per l of fluid
Contact time 5 days




Category(ies) of users


Industrial




Pack sizes and packaging material


For industrial and professional users:






—


HDPE flask: 5 l (nominal)










—


HDPE Pail / Jerrycan: 10 l, 20 l, 25 l, 30 l (nominal)










—


Box with HDPE liner: 20 l










—


HDPE Drum: 110 l, 120 l, 200 l, 260 l










—


HDPE IBC: 650 l, 800 l, 1000 l, 1250 l




All products should be transport and stored in a vented room.




4.7.1.   Use-specific instructions for use

Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.7.2.   Use-specific risk mitigation measures







—


Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.










—


During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:






—


Minimisation of manual phases (process automation);










—


Use of a dosing device;










—


Regular cleaning of equipment and work area;










—


Avoidance of contact with contaminated tools and objects;










—


Good standard of general ventilation;










—


Training and management of staff on good practice.














—


PPE is as follows:






—


protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);










—


protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);










—


Eye protection;










—


Substance/task appropriate respirator if ventilation is inadequate.














—


Liquids used in textile and fiber processing fluids must not enter surface water directly. Use product only in premises that are connected to a STP.










—


Recirculating liquids in photoprocessing systems and fountain solution systems must not enter surface water directly. Use product only in premises that are connected to a STP.




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

See general directions for use.
4.7.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See 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

See general directions for use.
4.8.   Use description


Table 8


Use # 8 – Preservation of re-circulating liquids used in paint spray booths and electrodeposition coating systems







Product type


PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:




Field(s) of use


Indoor
Preservation of re-circulating liquids used in paint spray booths and electrodeposition coating systems.
The biocidal product is used for preservation of fluids in pre- treatment processes (Cleaning treatment for grease removal and soil, degreasing Phosphating process, Rinse off tanks) paint spray booths and electrodeposition coating systems (e.g. cataphoretic baths) applied in Car Refinishing and Original equipment Car Manufacturing to control the integrity of recirculating fluid by reducing microbial contamination from bacteria and fungi in the bulk solution.




Application method(s)


Method: -
Detailed description:
-




Application rate(s) and frequency


Application Rate: Preventive treatment: 7,5 to 30 mg C(M)IT/MIT (3:1) per kg final product.
Dilution (%): -
Number and timing of application:
Preventive treatment: 7,5 to 30 mg C(M)IT/MIT (3:1) per Kg final product.
The biocidal product is added at the time of manufacture, storage or shipment.




Category(ies) of users


Industrial




Pack sizes and packaging material


For industrial and professional users:






—


HDPE flask: 5 l (nominal)










—


HDPE Pail / Jerrycan: 10 l, 20 l, 25 l, 30 l (nominal)










—


Box with HDPE liner: 20 l










—


HDPE Drum: 110 l, 120 l, 200 l, 260 l










—


HDPE IBC: 650 l, 800 l, 1000 l, 1250 l




All products should be transport and stored in a vented room.




4.8.1.   Use-specific instructions for use

Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.8.2.   Use-specific risk mitigation measures







—


Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.










—


During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:






—


Minimisation of manual phases (process automation);










—


Use of a dosing device;










—


Regular cleaning of equipment and work area;










—


Avoidance of contact with contaminated tools and objects;










—


Good standard of general ventilation;










—


Training and management of staff on good practice.














—


PPE is as follows:






—


protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);










—


protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);










—


Eye protection;










—


Substance/task appropriate respirator if ventilation is inadequate.








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

See general directions for use.
4.8.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See 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

See general directions for use.
4.9.   Use description


Table 9


Use # 9 – Preservation of liquids used in closed recirculating heating systems and associated pipework







Product type


PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria (anaerobes and aerobes (including Legionella pneumophila)
Development stage:
Common name: Yeasts
Development stage:
Common name: Fungi
Development stage:




Field(s) of use


Indoor
Outdoor
Preservation of liquids used in closed recirculating heating systems and associated pipework. Pre-commission biocide flushing of new or existing pipework systems (heating and chilling pipework) includes used or new structural pipework built on industrial building projects.
Closed recirculating heating systems: pre-commission biocidal product flushing of new or existing pipework systems (heating and chilling pipework) includes used or new structural pipework built on industrial building projects. The biocidal product is used to control the growth of aerobic and anaerobic bacteria, fungi and biofilm in the circulating water of closed systems. Closed systems are less susceptible to corrosion, scaling and biological fouling than open systems. However microbial problems can occur, if the system is left filled and untreated. This is due to the presence of nitrite and glycols used as nutrients by microbes.




Application method(s)


Method: Closed system
Detailed description:
Manual and automated dosing.
The biocidal product is dosed automatically in the heat transfer fluid, in a place of good mixing. The feeding pipe must dose the biocidal product below the water level in order to limit the evaporation of the biocidal product.




Application rate(s) and frequency


Application Rate:
Curative treatment






—


against bacteria at 5 g C(M)IT/MIT (3:1) / m3 of water (including L. pneumophila)










—


against biofilm at 14,9 g C(M)IT/MIT (3:1) / m3 of water










—


against fungi and yeast at 1 g C(M)IT/MIT / m3 of water




Preventive treatment






—


against bacteria (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m3 of water










—


against biofilm at 3 g C(M)IT/MIT (3:1) / m3 of water.




Dilution (%): -
Number and timing of application:






 


Curative treatment:






—


against bacteria at 5 g C(M)IT/MIT (3:1) / m3 of water (including L. pneumophila)














 


Contact time: 24 hours






—


against biofilm at 14,9 g C(M)IT/MIT (3:1) / m3 of water














 


Contact time: 24 hours






—


against fungi and yeast at 1 g C(M)IT/MIT / m3 of water Contact time: 48 hours














 


Preventive treatment






—


against bacteria (including L. pneumophila) at 3 g C(M)IT/MIT (3:1) / m3 of water and against biofilm at 3 g C(M)IT/MIT (3:1) / m3 of water.












Category(ies) of users


Industrial




Pack sizes and packaging material


For industrial and professional users:






—


HDPE flask: 5 l (nominal)










—


HDPE Pail / Jerrycan: 10 l, 20 l, 25 l, 30 l (nominal)










—


Box with HDPE liner: 20 l










—


HDPE Drum: 110 l, 120 l, 200 l, 260 l










—


HDPE IBC: 650 l, 800 l, 1000 l, 1250 l




All products should be transport and stored in a vented room.




4.9.1.   Use-specific instructions for use

Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.9.2.   Use-specific risk mitigation measures







—


Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.










—


During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:






—


Minimisation of manual phases (process automation);










—


Use of a dosing device;










—


Regular cleaning of equipment and work area;










—


Avoidance of contact with contaminated tools and objects;










—


Good standard of general ventilation;










—


Training and management of staff on good practice.














—


PPE is as follows:






—


protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);










—


protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);










—


Eye protection;










—


Substance/task appropriate respirator if ventilation is inadequate.








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

See general directions for use.
4.9.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See 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

See general directions for use.
4.10.   Use description


Table 10


Use # 10 – Preservation of polymers used in oilfield processes (e.g. enhanced oil recovery, drilling muds, etc.)







Product type


PT11 - Preservatives for liquid-cooling and processing systems (Preservatives)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:




Field(s) of use


Outdoor
Preservation of polymers used in oilfield processes (e.g. enhanced oil recovery, drilling muds, etc.)




Application method(s)


Method: -
Detailed description:
-




Application rate(s) and frequency


Application Rate: Preventive treatment of polymers used in the injection water: Xanthan polymer: 30 -50 g C(M)IT/MIT/m3 solution. HPAM polymer: 30 - 50 g C(M)IT/MIT/m3 solution. Preventive treatment of polymers used in the drilling muds: Xanthan polymer: 30 g C(M)IT/MIT/m3 solution. HPAM polymer: 30 g C(M)IT/MIT/m3 solution.
Dilution (%): -
Number and timing of application:
Preventive treatment of polymers used in the injection water:
Xanthan polymer: 30 -50 g C(M)IT/MIT/m3 solution.
HPAM polymer: 30 - 50 g C(M)IT/MIT/m3 solution.
Preventive treatment of polymers used in the drilling muds:
Xanthan polymer: 30 g C(M)IT/MIT/m3 solution.
HPAM polymer: 30 g C(M)IT/MIT/m3 solution.




Category(ies) of users


Industrial




Pack sizes and packaging material


For industrial and professional users:






—


HDPE flask: 5 l (nominal)










—


HDPE Pail / Jerrycan: 10 l, 20 l, 25 l, 30 l (nominal)










—


Box with HDPE liner: 20 l










—


HDPE Drum: 110 l, 120 l, 200 l, 260 l










—


HDPE IBC: 650 l, 800 l, 1000 l, 1250 l




All products should be transport and stored in a vented room.




4.10.1.   Use-specific instructions for use

Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.10.2.   Use-specific risk mitigation measures







—


Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.










—


During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:






—


Minimisation of manual phases (process automation);










—


Use of a dosing device;










—


Regular cleaning of equipment and work area;










—


Avoidance of contact with contaminated tools and objects;










—


Good standard of general ventilation;










—


Training and management of staff on good practice.














—


PPE is as follows:






—


protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);










—


protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);










—


Eye protection;










—


Substance/task appropriate respirator if ventilation is inadequate.








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

See general directions for use.
4.10.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See 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

See general directions for use.
4.11.   Use description


Table 11


Use # 11 – Slimicide treatment in the de-inking process of the pulp and paper







Product type


PT12 - Slimicides (Preservatives)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Fungi
Development stage:




Field(s) of use


Indoor
Slimicide treatment in the de-inking process of the pulp and paper. Recycling paper /deinking paper mills. Deinking process is a manufacturing paper process of removing printing inks from waste paper-fibers to produce deinked pulp.




Application method(s)


Method: Closed system
Detailed description:
Manual and automated dosing.
The biocidal product is automatically dosed by pump and fixed pipes into the circuit, usually in the pulper below the water level.




Application rate(s) and frequency


Application Rate: Curative treatment: 10 to 14,9 g C(M)IT/MIT (3:1) / m3 of water to be treated. Preventive treatment: 5 g C(M)IT/MIT (3:1) / m3 of water to be treated.
Dilution (%): -
Number and timing of application:
Curative treatment: 10 to 14,9 g C(M)IT/MIT (3:1) / m3 of water to be treated
Contact time: 24 hours
Preventive treatment: 5 g C(M)IT/MIT (3:1) / m3 of water to be treated.




Category(ies) of users


Industrial




Pack sizes and packaging material


For industrial and professional users:






—


HDPE flask: 5 l (nominal)










—


HDPE Pail / Jerrycan: 10 l, 20 l, 25 l, 30 l (nominal)










—


Box with HDPE liner: 20 l










—


HDPE Drum: 110 l, 120 l, 200 l, 260 l










—


HDPE IBC: 650 l, 800 l, 1000 l, 1250 l




All products should be transport and stored in a vented room.




4.11.1.   Use-specific instructions for use

Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.11.2.   Use-specific risk mitigation measures







—


Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.










—


During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:






—


Minimisation of manual phases (process automation);










—


Use of a dosing device;










—


Regular cleaning of equipment and work area;










—


Avoidance of contact with contaminated tools and objects;










—


Good standard of general ventilation;










—


Training and management of staff on good practice.














—


PPE is as follows:






—


protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);










—


protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);










—


Eye protection;










—


Substance/task appropriate respirator if ventilation is inadequate.








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

See general directions for use.
4.11.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See 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

See general directions for use.
4.12.   Use description


Table 12


Use # 12 – Slimicide treatment in the wet-end stage of paper manufacturing process







Product type


PT12 - Slimicides (Preservatives)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:
Common name: Yeasts
Development stage:
Common name: Fungi
Development stage:




Field(s) of use


Indoor
Slimicide treatment in the wet-end stage of the paper manufacturing process (paper mills, wet-end stage (water circuits), and paper mills process system).




Application method(s)


Method: Closed system
Detailed description:
Manual and automated dosing.




Application rate(s) and frequency


Application Rate: Curative treatment: 10 to 14,9 g C(M)IT/MIT (3:1) / m3 of water to be treated. Preventive treatment: 5 g C(M)IT/MIT (3:1) / m3 of water to be treated.
Dilution (%): -
Number and timing of application:
Curative treatment: 10 to 14,9 g C(M)IT/MIT (3:1) / m3 of water to be treated
Contact time: 24 hours
Preventive treatment: 5 g C(M)IT/MIT (3:1) / m3 of water to be treated.




Category(ies) of users


Industrial




Pack sizes and packaging material


For industrial and professional users:






—


HDPE flask: 5 l (nominal)










—


HDPE Pail / Jerrycan: 10 l, 20 l, 25 l, 30 l (nominal)










—


Box with HDPE liner: 20 l










—


HDPE Drum: 110 l, 120 l, 200 l, 260 l










—


HDPE IBC: 650 l, 800 l, 1000 l, 1250 l




All products should be transport and stored in a vented room.




4.12.1.   Use-specific instructions for use

Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.12.2.   Use-specific risk mitigation measures







—


Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.










—


During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:






—


Minimisation of manual phases (process automation);










—


Use of a dosing device;










—


Regular cleaning of equipment and work area;










—


Avoidance of contact with contaminated tools and objects;










—


Good standard of general ventilation;










—


Training and management of staff on good practice.














—


PPE is as follows:






—


protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);










—


protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);










—


Eye protection;










—


Substance/task appropriate respirator if ventilation is inadequate.














—


The use of C(M)IT/MIT (3:1) containing products for the slimicide treatment in the wet-end stage of the paper manufacturing process is restricted to:






(a)


curative treatments in plants connected to a slimicide-free water from a pulp mill and only for the treatment of the short circulation of the paper mill; and










(b)


preventive treatments,
and, for both cases, only if the factory’s waste water is purified in an on-site (full) industrial sewage treatment plant with a minimal capacity of 5000 m3 per day as described in the Industrial Emission Directive 2010/75/EU (Best Available Techniques for the production of pulp, paper and board) and if a dilution of at least 200 times in surface water is achieved after the industrial sewage treatment plant.








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

See general directions for use.
4.12.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See 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

See general directions for use.
4.13.   Use description


Table 13


Use # 13 – Preventive treatment (biofouling control) online and after cleaning in place for industrial RO/NF membranes







Product type


PT12 - Slimicides (Preservatives)




Where relevant, an exact description of the authorised use


-




Target organism(s) (including development stage)


Common name: Bacteria
Development stage:




Field(s) of use


Indoor
Preventive treatment (biofouling control) online and after cleaning in place for industrial RO/NF membranes




Application method(s)


Method: Closed system
Detailed description:
Manual and automated dosing.
Biocidal product application on a routine basis will prevent biofilm growth on Reverse Osmosis or Nano Filtration membrane surfaces, feed spacer, filter media and pipework. The biocidal product should be dispensed to the feed water at a point to assure adequate mixing throughout the system.




Application rate(s) and frequency


Application Rate: Preventive treatment: 5 g C(M)IT/MIT (3:1) per m3 of fluid
Dilution (%): -
Number and timing of application:
Preventive treatment: 5 g C(M)IT/MIT (3:1) per m3 of fluid




Category(ies) of users


Industrial




Pack sizes and packaging material


For industrial and professional users:






—


HDPE flask: 5 l (nominal)










—


HDPE Pail / Jerrycan: 10 l, 20 l, 25 l, 30 l (nominal)










—


Box with HDPE liner: 20 l










—


HDPE Drum: 110 l, 120 l, 200 l, 260 l










—


HDPE IBC: 650 l, 800 l, 1000 l, 1250 l




All products should be transport and stored in a vented room.




4.13.1.   Use-specific instructions for use

Microbiological tests to prove adequacy of preservation have to be undertaken by the user of C(M)IT/MIT products in order to determine the effective dose of the preservative for the specific matrix/location/system. If needed, consult the manufacturer of the preservative product.
4.13.2.   Use-specific risk mitigation measures







—


Rinse the system (especially the dispensing pumps) with water prior to perform the cleaning step.










—


During handling phases (mixing and loading) and cleaning of the dispensing pumps, exposure to the product (corrosive and skin sensitizer product) has to be limited by use of PPE and application of technical and organisational RMM:






—


Minimisation of manual phases (process automation);










—


Use of a dosing device;










—


Regular cleaning of equipment and work area;










—


Avoidance of contact with contaminated tools and objects;










—


Good standard of general ventilation;










—


Training and management of staff on good practice.














—


PPE is as follows:






—


protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information);










—


protective coverall (at least type 3 or 4, EN 14605) which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information);










—


Eye protection;










—


Substance/task appropriate respirator if ventilation is inadequate.














—


Use product only in premises that are connected to a STP.




4.13.3.   Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

See general directions for use.
4.13.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use.
4.13.5.   Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storage

See general directions for use.
5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1
5.1.   Instructions for use







—


The duration of the effect is dependent on the performance requirements of the customer for their preserved material and on the specific ingredients composition and pH of the preserved product.










—


Always read the label or leaflet before use and follow all the instructions provided.










—


Respect the conditions of use of the product (concentration, contact time, temperature, pH, etc.)




PRECAUTIONARY MEASURES DURING STORAGE AND TRANSPORT:
Keep in a well-ventilated place. The product as supplied may evolve gas (largely carbon dioxide) slowly. To prevent the buildup of pressure the product is packaged in specially vented containers, where necessary. Keep this product in the original container when not in use. Container must be stored and transported in an upright position to prevent spilling the contents through the vent, where fitted.
5.2.   Risk mitigation measures

-
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment







—


Skin contact: Remove contaminated clothing and shoes. Wash contaminated skin with water. Contact poison treatment specialist if symptoms occur.










—


Eye contact: Immediately flush with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any contact lenses if easy to do. Continue to rinse with tepid water for at least 30 minutes. Call 112/ambulance for medical assistance.










—


Ingestion: Wash out mouth with water. Contact poison treatment specialist. Seek medical advice immediately if symptoms occur and/or large quantities have been ingested. Do not give fluids or induce vomiting.










—


Inhalation (of spray mist): Remove victim to fresh air and keep at rest in a position comfortable for breathing. Seek medical advice immediately if symptoms occur and/or large quantities have been inhaled.










—


In case of impaired consciousness place in recovery position and seek medical advice immediately.










—


Keep the container or label available.




5.4.   Instructions for safe disposal of the product and its packaging







—


Do not discharge unused product on the ground, into water courses, into pipes (e.g. sink, toilets) nor down the drains.










—


Dispose of unused product, its packaging and all other waste, in accordance with local regulations.




5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Conditions for safe storage, including any incompatibilities: Keep in a dry, cool and well-ventilated place, in the original container.
Shelf-life: 12 months
Protect from sunlight.
Recommendation: If a metal packaging is used, a varnish layer should be applied.
6.   OTHER INFORMATION
-
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)


Spectrum™ RX6804 MICROBIOCIDE


Market area: EU




Authorisation number


EU-0025678-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)


 


Active Substance


55965-84-9


 


5,9




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












Trade name(s)


Spectrum™ PR3126 PRESERVATIVE


Market area: EU




 


Spectrum™ RX8560 MICROBIOCIDE


Market area: EU




Spectrum™ RX7827 MICROBIOCIDE


Market area: EU




Authorisation number


EU-0025678-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)


 


Active Substance


55965-84-9


 


3,2




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












Trade name(s)


Biosperse™ 250 MICROBIOCIDE


Market area: EU




Biosperse™ 251 MICROBIOCIDE


Market area: EU




Biosperse™ 850 MICROBIOCIDE


Market area: EU




Biosperse™ 851 MICROBIOCIDE


Market area: EU




Spectrum™ RX6810 MICROBIOCIDE


Market area: EU




Spectrum™ RX6820 MICROBIOCIDE


Market area: EU




Authorisation number


EU-0025678-0003 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Mixture of 5-chloro-2-methyl-2H- isothiazol-3-one (EINECS 247-500-7) and 2-methyl-2H-isothiazol-3-one (EINECS 220-239-6) (Mixture of CMIT/MIT)


 


Active Substance


55965-84-9


 


2,3






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