Commission Implementing Regulation (EU) 2024/2175 of 3 September 2024 granting a Union authorisation for the biocidal product family Contec Calcium Hypochlorite Product Family in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2024-09-03
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, chlorine, decontamination, market approval








L_202402175EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2024/2175


4.9.2024







            COMMISSION IMPLEMENTING REGULATION (EU) 2024/2175
of 3 September 2024
         
granting a Union authorisation for the biocidal product family ‘Contec Calcium Hypochlorite Product 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 19 December 2018, Contec Europe 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 ‘Contec Calcium Hypochlorite Product Family’ of product-type 2, 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-LY047116-11 in the Register for Biocidal Products.












(2)


‘Contec Calcium Hypochlorite Product Family’ contains active chlorine released from calcium hypochlorite as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 2.












(3)


On 17 July 2023, 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 14 December 2023, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Contec Calcium Hypochlorite Product 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 ‘Contec Calcium Hypochlorite Product 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(1) and (6) of that Regulation.












(6)


On 8 January 2024, 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.












(7)


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












(8)


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





HAS ADOPTED THIS REGULATION:



Article 1
A Union authorisation with authorisation number EU-0032017-0000 is hereby granted to Contec Europe for the making available on the market and use of the biocidal product family ‘Contec Calcium Hypochlorite Product Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex.
The Union authorisation is valid from 24 September 2024 until 31 August 2034.


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, 3 September 2024.


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 22 November 2023 on the Union authorisation of ‘Contec Calcium Hypochlorite Product Family’ (ECHA/BPC/403/2023) (https://echa.europa.eu/opinions-on-union-authorisation).




ANNEX

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

Contec Calcium Hypochlorite Product Family

Product type 2 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Authorisation number: EU-0032017-0000

R4BP asset number: EU-0032017-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


Contec Calcium Hypochlorite Product Family




1.2.   Product type(s)







Product type(s)


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Contec Europe




Address


Zl Du Prat, avenue Paul Duplaix, 56000 Vannes, France




Authorisation number


EU-0032017-0000





R4BP asset number



EU-0032017-0000




Date of the authorisation


24 September 2024




Expiry date of the authorisation


31 August 2034




1.4.   Manufacturer(s) of the biocidal products







Name of manufacturer


Contec Cleanroom (UK) Ltd.




Address of manufacturer


Lamport Drive, Heartlands Business Park, NN11 8YT Daventry, United Kingdom




Location of manufacturing sites


5, Badby Park, Heartlands Business Park, NN11 8YT Daventry, United Kingdom




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







Active substance


Active chlorine released from calcium hypochlorite




Name of manufacturer


Lonza Cologne GmbH




Address of manufacturer


Nattermannallee 1, 50829 Köln, Germany




Location of manufacturing sites


1200 Lower River Road, TN 37310 Charleston, United States




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




Active chlorine released from calcium hypochlorite


 


Active Substance


 


 


0,06 


0,2 




Calcium hypochlorite


Calcium hypochlorite


Releaser


7778-54-3


231-908-7


0,092 


0,31 




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 1




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




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




Active chlorine released from calcium hypochlorite


 


Active Substance


 


 


0,2 


0,2 




Calcium hypochlorite


Calcium hypochlorite


Releaser


7778-54-3


231-908-7


0,31 


0,31 




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


May be corrosive to metals.




Precautionary statements


Keep only in original packaging.
Absorb spillage to prevent material damage.




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

4.1.   Use description


Table 1


Use # 1 – Use 1.1 Hard surface disinfection in cleanrooms by trigger spray and wipe (PT 2)







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


N/A




Target organism(s) (including development stage)


Common name: Bacteria
Development stage: -
Common name: Bacterial spores
Development stage: -
Common name: Viruses
Development stage: -




Field(s) of use


Indoor
Disinfection of hard non-porous surfaces or equipment by spraying and wiping in cleanrooms which are classified according to ISO 14644-1 in class 1 to 8 or according to GMP EU classification in Grade A to C (e.g. pharmaceutical cleanrooms).




Application method(s)


Method: Spraying and wiping
Detailed description:
The ready-to-use (RTU) product is sprayed onto a cleanroom wipe and the product is applied by wiping on a pre-cleaned, hard, non-porous surface.




Application rate(s) and frequency


Dilution (%): ready-to-use (RTU) product
Number and timing of application:
Application rate: 50 ml/m2.
Contact time: 1 minute
Application frequency: Specific to the user’s site and requirements. Use temperature: room temperature




Category(ies) of users


Professional




Pack sizes and packaging material


RTU liquid spray packaged in 1 litre high-density polyethylene (HDPE) trigger spray bottles.




4.1.1.   Use-specific instructions for use

Before applying the ready-to-use product physically remove contaminants from the surface using a cleanroom wipe. Apply the product by spraying onto a cleanroom wipe and then wipe the surface. Ensure that the entire surface is visibly wet and uniform distribution of the biocidal product should be ensured. Leave for the required contact time of 1 minute for bacteria, bacterial spores and viruses and then wipe to dry the surface.
4.1.2.   Use-specific risk mitigation measures

See general directions for use
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 – Use 1.2 Hard surface disinfection in cleanrooms by wiping or mopping (PT 2)







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


N/A




Target organism(s) (including development stage)


Common name: Bacteria
Development stage: –
Common name: Bacterial spores
Development stage: –
Common name: Viruses
Development stage: -




Field(s) of use


Indoor
Disinfection of hard non-porous surfaces or equipment by wiping or mopping in cleanrooms (e.g. pharmaceutical cleanrooms).




Application method(s)


Method: Wiping or mopping
Detailed description:
The disinfection product is poured into a container and applied onto a pre-cleaned, hard, non-porous surface using a cleanroom wipe or mop.




Application rate(s) and frequency


Dilution (%): ready-to-use (RTU) product
Number and timing of application:
Application rate: 100 ml/m2

Contact time: 1 minute
Application frequency: Specific to the user’s site and requirements. Use temperature: room temperature




Category(ies) of users


Professional




Pack sizes and packaging material


RTU liquid packaged in 700 ml, 1 litre and 5 litre capped plastic high-density polyethylene (HDPE) bottles.




4.2.1.   Use-specific instructions for use

Before applying the ready-to-use product physically remove contaminants from the surface using a cleanroom wipe. Apply the product by pouring the product into a container and using a cleanroom wipe to apply to the surface. Ensure that the entire surface is visibly wet and uniform distribution of the biocidal product should be ensured. Leave for the required contact time of 1 minute for bacteria, bacterial spores and viruses and then wipe to dry the surface.
4.2.2.   Use-specific risk mitigation measures

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

5.1.   Instructions for use

See ‘Use-specific instructions for use’ sections for each meta SPC.
5.2.   Risk mitigation measures

Engineering measures: Ensure there is sufficient ventilation of the area.
All meta SPCs: Trigger spraying: only apply in rooms with a minimum ventilation rate of 20 air changes per hour (ACH). Only for disinfection of small size surfaces.
All meta SPCs: Wiping and mopping: only apply in rooms with a minimum ventilation rate of 40 ACH.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


First aid instructions

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.

Emergency measures to protect the environment

Do not discharge into drains or rivers. Contain the spillage using bunding. Absorb into dry earth or sand.
5.4.   Instructions for safe disposal of the product and its packaging

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

Store in a cool, well-ventilated area. Keep container tightly closed. Keep away from direct sunlight. Protect from frost. Store at temperatures not exceeding 20 °C.
Shelf-life: 12 months
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)


Contec ProChlor Sterile


Market area: EU




Authorisation number


EU-0032017-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Active chlorine released from calcium hypochlorite


 


Active Substance


 


 


0,2




Calcium hypochlorite


Calcium hypochlorite


Releaser


7778-54-3


231-908-7


0,31




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











Trade name(s)


Contec ProChlor


Market area: EU




Authorisation number


EU-0032017-0002 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Active chlorine released from calcium hypochlorite


 


Active Substance


 


 


0,2




Calcium hypochlorite


Calcium hypochlorite


Releaser


7778-54-3


231-908-7


0,31





META SPC 2

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)


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




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 (%)




Min


Max




Active chlorine released from calcium hypochlorite


 


Active Substance


 


 


0,06 


0,06 




Calcium hypochlorite


Calcium hypochlorite


Releaser


7778-54-3


231-908-7


0,092 


0,092 




2.2.   Type(s) of formulation of the meta SPC 2







Formulation(s)


AL – Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2







Hazard statements


May be corrosive to metals.




Precautionary statements


Keep only in original packaging.
Absorb spillage to prevent material damage.




4.   AUTHORISED USE(S) OF THE META SPC 2

4.1.   Use description


Table 3


Use # 1 – Use 2.1 Hard surface disinfection in cleanrooms by trigger spray and wipe (PT 2)







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


N/A




Target organism(s) (including development stage)


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




Field(s) of use


Indoor
For surface disinfection in cleanrooms which are classified according to ISO 14644-1 in class 1 to 8 or according to GMP EU classification in Grade A to C. The biocidal product is recommended for the control of bacteria and yeast on hard non-porous surfaces that will not come into contact with food or feed by spraying followed by wiping.




Application method(s)


Method: Spraying and wiping
Detailed description:
The ready-to-use (RTU) product is sprayed onto a cleanroom wipe and the product is applied by wiping on a pre-cleaned, hard, non-porous surface.




Application rate(s) and frequency


Dilution (%): ready-to-use (RTU) product
Number and timing of application:
Application rate: 50 ml/m2.
Contact time: 5 minutes
Application frequency: Specific to the user’s site and requirements. Use temperature: room temperature




Category(ies) of users


Professional




Pack sizes and packaging material


RTU liquid spray packaged in 1 litre high-density polyethylene (HDPE) trigger spray bottles.




4.1.1.   Use-specific instructions for use

Before applying the ready-to-use product physically remove contaminants from the surface using a cleanroom wipe. Apply the product by spraying onto a cleanroom wipe and then wipe the surface. Ensure that the entire surface is visibly wet and uniform distribution of the biocidal product should be ensured. Leave for the required contact time of 5 minutes for bacteria and yeast and then wipe to dry the surface.
4.1.2.   Use-specific risk mitigation measures

See general directions for use
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 4


Use # 2 – Use 2.2 Hard surface disinfection in cleanrooms by wiping or mopping (PT 2)







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


N/A




Target organism(s) (including development stage)


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




Field(s) of use


Indoor
Disinfection of hard non-porous surfaces or equipment by wiping or mopping in cleanrooms which are classified according to ISO 14644-1 in class 1 to 8 or according to GMP EU classification in Grade A to C (e.g. pharmaceutical cleanrooms).




Application method(s)


Method: Wiping or mopping
Detailed description:
The disinfection product is poured into a container and applied onto a pre-cleaned, hard, non-porous surface using a cleanroom wipe or mop.




Application rate(s) and frequency


Dilution (%): ready-to-use (RTU) product
Number and timing of application:
Application rate: 100 ml/m2

Contact time: 5 minutes
Application frequency: Specific to the user’s site and requirements. Use temperature: room temperature




Category(ies) of users


Professional




Pack sizes and packaging material


RTU liquid packaged in 700 ml, 1 litre and 5 litre capped plastic high-density polyethylene (HDPE) bottles.




4.2.1.   Use-specific instructions for use

Before applying the ready-to-use product physically remove contaminants from the surface using a cleanroom wipe. Apply the product by pouring the product into a container and using a cleanroom wipe to apply to the surface. Ensure that the entire surface is visibly wet and uniform distribution of the biocidal product should be ensured. Leave for the required contact time of 5 minutes for bacteria and yeast and then wipe to dry the surface.
4.2.2.   Use-specific risk mitigation measures

See general directions for use
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
5.   GENERAL DIRECTIONS FOR USE (2)
OF THE META SPC 2

5.1.   Instructions for use

See ‘Use-specific instructions for use’ sections for each meta SPC.
5.2.   Risk mitigation measures

Engineering measures: Ensure there is sufficient ventilation of the area.
All meta SPCs: Trigger spraying: only apply in rooms with a minimum ventilation rate of 20 ACH. Only for disinfection of small size surfaces.
All meta SPCs: Wiping and mopping: only apply in rooms with a minimum ventilation rate of 40 ACH.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


First aid instructions

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.

Emergency measures to protect the environment

Do not discharge into drains or rivers. Contain the spillage using bunding. Absorb into dry earth or sand.
5.4.   Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose unused product and the packaging in accordance with local requirements. Used product can be flushed to municipal sewer. Avoid release to an individual waste water treatment plant.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Store in a cool, well-ventilated area. Keep container tightly closed. Keep away from direct sunlight. Protect from frost. Store at temperatures not exceeding 20 °C.
Shelf-life: 12 months
6.   OTHER INFORMATION

—
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)


Contec CyChlor Sterile


Market area: EU




Authorisation number


EU-0032017-0003 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Active chlorine released from calcium hypochlorite


 


Active Substance


 


 


0,06




Calcium hypochlorite


Calcium hypochlorite


Releaser


7778-54-3


231-908-7


0,092




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











Trade name(s)


Contec CyChlor


Market area: EU




Authorisation number


EU-0032017-0004 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Active chlorine released from calcium hypochlorite


 


Active Substance


 


 


0,06




Calcium hypochlorite


Calcium hypochlorite


Releaser


7778-54-3


231-908-7


0,092





META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier







Identifier


meta SPC 3




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




2.   META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Active chlorine released from calcium hypochlorite


 


Active Substance


 


 


0,2 


0,2 




Calcium hypochlorite


Calcium hypochlorite


Releaser


7778-54-3


231-908-7


0,31 


0,31 




2.2.   Type(s) of formulation of the meta SPC 3







Formulation(s)


AL – Any other liquid




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3







Hazard statements


May be corrosive to metals.




Precautionary statements


Keep only in original packaging.
Absorb spillage to prevent material damage.




4.   AUTHORISED USE(S) OF THE META SPC 3

4.1.   Use description


Table 5


Use # 1 – Use 3.1 Hard surface disinfection in veterinary laboratories by trigger spray and wipe (PT 2)







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


N/A




Target organism(s) (including development stage)


Common name: Bacteria
Development stage: -
Common name: Yeasts
Development stage: -
Common name: Viruses
Development stage: -




Field(s) of use


Indoor
Disinfection of hard non-porous surfaces or equipment (excluding animal cages) by spraying followed by wiping in veterinary laboratories without pre-cleaning.




Application method(s)


Method: Spraying and wiping
Detailed description:
The ready-to-use (RTU) product is sprayed onto a surface and distributed with a wipe. The product is applied on a hard, non-porous surface.




Application rate(s) and frequency


Dilution (%): ready-to-use (RTU) product
Number and timing of application:
Application rate: 50 ml/m2.
Contact time: 30 minutes
Application frequency: Specific to the user’s site and requirements. Temperature: room temperature.




Category(ies) of users


Professional




Pack sizes and packaging material


RTU liquid spray packaged in 1 litre high-density polyethylene (HDPE) trigger spray bottles.




4.1.1.   Use-specific instructions for use

Disinfection of hard non-porous surfaces or equipment in veterinary laboratories: Apply the product by spraying the product onto the surface and distribute the product with a wipe. Ensure that the entire surface is visibly wet and that the biocidal product is uniformly distributed. Leave for the required contact time of 30 minutes for bacteria, yeast and viruses and then wipe to dry the surface.
4.1.2.   Use-specific risk mitigation measures

See general directions for use
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 6


Use # 2 – Use 3.2 Hard surface disinfection in veterinary laboratories by pouring and subsequent wiping or mopping (PT 2)







Product type


PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)




Where relevant, an exact description of the authorised use


N/A




Target organism(s) (including development stage)


Common name: Bacteria
Development stage: -
Common name: Yeasts
Development stage: -
Common name: Viruses
Development stage: -




Field(s) of use


Indoor
Disinfection of hard non-porous surfaces or equipment (excluding animal cages) by pouring followed by wiping/mopping in veterinary laboratories without pre-cleaning.




Application method(s)


Method: Pouring and mopping/wiping
Detailed description:
Application by pouring onto a surface followed by wiping/mopping using a wipe or mop to distribute the product.




Application rate(s) and frequency


Dilution (%): ready-to-use (RTU) product
Number and timing of application:
Application rate: 100 ml/m2

Contact time: 30 minutes
Application frequency: Specific to the user’s site and requirements. Temperature: room temperature




Category(ies) of users


Professional




Pack sizes and packaging material


RTU liquid packaged in 700 ml, 1 litre and 5 litre capped plastic high-density polyethylene (HDPE) bottles.




4.2.1.   Use-specific instructions for use

Disinfection of hard non-porous surfaces or equipment in veterinary laboratories: Apply the product by pouring the product onto the surface and distribute the product with a suitable wipe or mop. Ensure that the entire surface is visibly wet and that the biocidal product is uniformly distributed. Leave for the required contact time of 30 minutes for bacteria, yeast and viruses and then wipe to dry the surface.
4.2.2.   Use-specific risk mitigation measures

See general directions for use
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
5.   GENERAL DIRECTIONS FOR USE (3)
OF THE META SPC 3

5.1.   Instructions for use

See ‘Use-specific instructions for use’ sections for each meta SPC.
5.2.   Risk mitigation measures

Engineering measures: Ensure there is sufficient ventilation of the area.
All meta SPCs: Trigger spraying: only apply in rooms with a minimum ventilation rate of 20 ACH. Only for disinfection of small size surfaces.
All meta SPCs: Wiping and mopping: only apply in rooms with a minimum ventilation rate of 40 ACH.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment


First aid instructions

IF INHALED: If symptoms occur call a POISON CENTRE or a doctor.
IF SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor.
IF ON SKIN: Wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.
IF IN EYES: If symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.

Emergency measures to protect the environment

Do not discharge into drains or rivers. Contain the spillage using bunding. Absorb into dry earth or sand.
5.4.   Instructions for safe disposal of the product and its packaging

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

Store in a cool, well-ventilated area. Keep container tightly closed. Keep away from direct sunlight. Protect from frost. Store at temperatures not exceeding 20 °C.
Shelf-life: 12 months
6.   OTHER INFORMATION

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7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 3

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











Trade name(s)


Contec ProChlor V


Market area: EU




Authorisation number


EU-0032017-0005 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Active chlorine released from calcium hypochlorite


 


Active Substance


 


 


0,2




Calcium hypochlorite


Calcium hypochlorite


Releaser


7778-54-3


231-908-7


0,31






(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.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.



ELI: http://data.europa.eu/eli/reg_impl/2024/2175/oj
ISSN 1977-0677 (electronic edition)