Commission Implementing Regulation (EU) 2018/1287 of 24 September 2018 granting a Union authorisation for the biocidal product family Quat-Chem's iodine based products (Text with EEA relevance.)
Date: 2018-09-24
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal health, chemical product, decontamination, food safety, iodine, market approval








L_2018240EN.01001001.xml










25.9.2018   


EN


Official Journal of the European Union


L 240/10








            COMMISSION IMPLEMENTING REGULATION (EU) 2018/1287
of 24 September 2018
         
granting a Union authorisation for the biocidal product family Quat-Chem's iodine based products
(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) thereof,

Whereas:







(1)


On 24 July 2015, Quatchem Ltd 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 a same biocidal product family, as referred to in Article 1 of Regulation (EU) No 414/2013, named Quat-chem's iodine based products (‘the same product family’) of product-type 3, as described in Annex V to Regulation (EU) No 528/2012. The application for the same product family was recorded under the case number BC-YN018814-15 in the Register for Biocidal Products (‘the Register’). The application also indicated the application number of the related reference product family (Hypred's iodine based products), recorded in the Register under the case number BC-LC018584-49.












(2)


The same product family contains iodine, as 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. Taking into account the intrinsic properties of the active substance, once the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (3) will become applicable, the Commission will consider the need to review of the approval of iodine, including polyvinylpyrrolidone iodine, in accordance with Article 15 of Regulation (EU) No 528/2012. Depending on the outcome of that review, the Commission will then consider whether the Union authorisations for biocidal products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012.












(3)


On 26 January 2018, the Agency submitted to the Commission an opinion (4), including the draft summary of the biocidal product characteristics (hereinafter ‘SPC’), in accordance with Article 6(2) of Regulation (EU) No 414/2013. The opinion concluded that the same product family falls within the definition of ‘biocidal product family’ laid down in Article 3(1)(s) of Regulation (EU) No 528/2012, that the proposed differences between the same 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 Implementing Regulation (EU) No 354/2013 (5), and that based on the assessment of the abovementioned related reference product family and subject to compliance with the draft SPC, the same product family meets the conditions laid down in Article 19(1) and (6) of Regulation (EU) No 528/2012.












(4)


On 13 March 2018, 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.












(5)


The Commission concurs with the opinion of the Agency and considers therefore appropriate to grant a Union authorisation for the same product family, and to record the SPC in the Register in accordance with Article 71(6) of that Regulation.












(6)


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 is granted to Quatchem Ltd for the same biocidal product family Quat-chem's iodine based products with authorisation number EU-0018496-0000.
The Union authorisation is valid from 15 October 2018 until 30 September 2028.
The Union authorisation is subject to compliance with the SPC set out in the Annex.


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, 24 September 2018.


For the Commission


The President

Jean-Claude JUNCKER
            





(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)  Commission delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).

(4)  ECHA opinion of 25 January 2018 on the Union authorisation of the same biocidal product family QUAT-CHEM's iodine based products (UBP-C-1177989-01-00/F).

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




ANNEX

Summary of product characteristics for a biocidal product family

QUAT-CHEM's iodine based products
Product type 3 — Veterinary hygiene (Disinfectants)
Authorisation number: EU-0018496-0000
R4BP asset number: EU-0018496-0000
PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name







Name


QUAT-CHEM's iodine based products




 


 




1.2.   Product type(s)







Product type(s)


PT03 - Veterinary hygiene (Disinfectants)




 


 




1.3.   Authorisation holder








Name and address of the authorisation holder


Name


Quatchem Ltd




Address


4 Dodgson Street, OL16 5SJ, Rochdale, United Kingdom




Authorisation number


EU-0018496-0000





R4BP asset number



EU-0018496-0000




Date of the authorisation


15 October 2018




Expiry date of the authorisation


30 September 2028




1.4.   Manufacturer(s) of the biocidal products







Name of manufacturer


QUAT-CHEM LTD




Address of manufacturer


Charter House 33 - Greek Street SK3 8AX Stockport United Kingdom




Location of manufacturing sites


QUAT-CHEM LTD - Charter House 33 - Greek Street SK3 8AX Stockport United Kingdom




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







Active substance


Iodine




Name of manufacturer


COSAYACH: SCM Cía. Cosayach Minera Negreiros, Rut. N°96.625.710-5




Address of manufacturer


Terrenos de Elena S/N Terrenos de Elena S/N Huara, Región de Tarapacá Chile




Location of manufacturing sites


Mined at: S.C.M. Cía. Minera Negreiros, S.C.M. Cosayach Soledad.
Refined at: S.C.M. Cía. Minera Negreiros. Pozo Almonte Chile













Active substance


Iodine




Name of manufacturer


ACF MINERA SA




Address of manufacturer


San Martín 499 Iquique Chile




Location of manufacturing sites


Faena Lagunas KM. 1.722 Ruta A-5, Pozo Almonte Chile













Active substance


Iodine




Name of manufacturer


SOCIEDAD QUIMICA y MINERA SA




Address of manufacturer


Los Militares 4290 SANTIAGO DE CHILE Chile




Location of manufacturing sites


Pedro de Valdivia (PV) Route B 180 Antofagasta Chile
Nueva Victoria (NV) Route 5 North, Km 1925 Pozo Almonte Chile




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




Iodine


 


Active substance


7553-56-2


231-442-4


0,25


2,5




Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)


Poly(oxy-1,2-ethanediyl),-C12-14-(even numbered)-alkyl-hydroxy


Non active substance


68439-50-9


 


2,697


24,199




2.2.   Type(s) of formulation







Formulation(s)


AL - Any other liquid




 


SL - Soluble concentrate




PART II

SECOND INFORMATION LEVEL - META SPCs


META SPC 1

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







Identifier


meta SPC 1: Dipping products - ready to use




1.2.   Suffix to the authorisation number







Number


1-1




1.3.   Product type(s)







Product type(s)


PT03 - Veterinary hygiene (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




Iodine


 


Active substance


7553-56-2


231-442-4


0,25


0,49




Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)


Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy


Non active substance


68439-50-9


 


2,697


4,993




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







Formulation


AL - Any other liquid




 


 




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1






Hazard statements


Causes serious eye irritation.
Harmful to aquatic life with long lasting effects.




Precautionary statements


Keep out of reach of children.
Wash hands thoroughly after handling.
Wear protective gloves.
Wear protective clothing.
Wear eye protection.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists: Get medical advice/attention.




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


Table 1. Use # 1 – Manual or automated dipping after milking







Product Type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Bacteria
Yeasts
Algae




Field(s) of use


Indoor
Disinfection of teats of milk producing animals by dipping after milking




Application method(s)


Dipping
Manual or automated disinfection of teats by dipping after milking.
Dipping cup or automated dipping machine.




Application rate(s) and frequency








—


cows and buffaloes (3 to 10 ml: 5 ml recommended)










—


sheep (1,5 to 5 ml: 1,5 ml recommended)










—


goats (2,5 to 6 ml: 2,5 ml recommended)




Frequency: 2 to 3 times per day




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE JERRYCAN 5, 10, 22 l
HDPE DRUM 60, 120, 220 l
HDPE CONTAINER 1 000  l




4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 1
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 1
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 of meta SPC 1
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

None: see directions for use meta SPC 1
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 of meta SPC 1
5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1
5.1.   Instructions for use

Always read the label or leaflet before use and follow all the instructions provided.
The product must be brought to a temperature above 20 °C before use.
The use of a dosing pump for filling the product into the application equipment is recommended.
Fill the dipping cup manually or automatically with the ready to use product.
Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.






—


cows and buffaloes (3 to 10 ml: 5 ml recommended)










—


sheep (1,5 to 5 ml: 1,5 ml recommended)










—


goats (2,5 to 6 ml: 2,5 ml recommended)




Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).
At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
Where necessary, repeat the application after each milking.
Clean the application equipment regularly with warm water.
5.2.   Risk mitigation measures

Wear eye protection.
In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.
FIRST AID INSTRUCTIONS






—


In the event of inhalation: Bring to fresh air.










—


In the event of contact with the skin: Wash with water.










—


In the event of contact with the eyes:
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists: Get medical advice/attention.










—


In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.




Refer to the safety data sheet available for professional user: it contains an emergency phone number.
Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.
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 the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 2 years in HDPE
Do not store at a temperature higher than 30 °C.
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)


Teatsan 2500
IODO GUARD 2500




Authorisation number


EU-0018496-0001 1-1




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active substance


7553-56-2


231-442-4


0,25




Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)


Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy


Non active substance


68439-50-9


 


2,697





META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 2 identifier







Identifier


meta SPC 2: Dipping, foaming, spraying products - Ready to use




1.2.   Suffix to the authorisation number







Number


1-2




1.3.   Product type(s)







Product type(s)


PT03 - Veterinary hygiene (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




Iodine


 


Active substance


7553-56-2


231-442-4


0,25


0,49




Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)


Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy


Non active substance


68439-50-9


 


2,697


4,69




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







Formulation


AL - Any other liquid




 


 




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2






Hazard statements


Causes serious eye irritation.
Harmful to aquatic life with long lasting effects.




Precautionary statements


Keep out of reach of children.
Wash hands thoroughly after handling.
Wear protective gloves.
Wear protective clothing.
Wear eye protection.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists: Get medical advice/attention.




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


Table 2. Use # 1 – Manual or automated dipping, foaming or spraying before milking







Product Type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Bacteria
Yeasts




Field(s) of use


Indoor
Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking




Application method(s)


Dipping, foaming or spraying before milking
Manual or automated disinfection of teats by dipping, foaming or spraying before milking
Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine




Application rate(s) and frequency








—


cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended)










—


sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)










—


goats (2,5 to 6 ml: 2,5 to 4 ml recommended)




Frequency: 2 to 3 times per day




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE JERRYCAN 5, 10, 22 l
HDPE DRUM 60, 120, 220 l
HDPE CONTAINER 1 000  l




4.1.1.   Use-specific instructions for use

Eliminate all visible dirt before applying the product.
Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.
Let the product act at least one minute.
Use the teat cleaning and wiping method systematically before attaching the milking cluster.
See also general instructions for use of meta SPC 2.
4.1.2.   Use-specific risk mitigation measures

For manual dipping/foaming application: Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/eye protection.
For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.
In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.
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 of meta SPC 2
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 2
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 of meta SPC 2
4.2.   Use description


Table 3. Use # 2 – Manual or automated dipping, foaming or spraying after milking







Product Type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Bacteria
Yeasts
Algae




Field(s) of use


Indoor
Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking




Application method(s)


Dipping, foaming, spraying after milking
Manual or automated disinfection of teats by dipping, foaming or spraying after milking.
Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine




Application rate(s) and frequency








—


cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended)










—


sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)










—


goats (2,5 to 6 ml: 2,5 to 4 ml recommended)








Category(ies) of users


Professional




Pack sizes and packaging material


HDPE JERRYCAN 5, 10, 22 l
HDPE DRUM 60, 120, 220 l
HDPE CONTAINER 1 000  l




4.2.1.   Use-specific instructions for use

Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat after milking.
Leave the product until next milking. Keep the cows standing until the product has dried. (at least 5 minutes)
At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
See also general instructions for use of meta SPC 2.
4.2.2.   Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.
In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
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 of meta SPC 2
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

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

See use-specific instructions for each use.
Always read the label or leaflet before use and follow all the instructions provided.
The product must be brought to a temperature above 20 °C before use.
The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.
Where necessary repeat the application at each milking.
Clean the application equipment regularly with warm water.
5.2.   Risk mitigation measures

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.
FIRST AID INSTRUCTIONS






—


In the event of inhalation: Bring to fresh air.










—


In the event of contact with the skin: Wash with water.










—


In the event of contact with the eyes:
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists: Get medical advice/attention.










—


In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.




Refer to the safety data sheet available for professional user: it contains an emergency phone number.
Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.
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 the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 2 years in HDPE
Do not store at a temperature higher than 30 °C.
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)


Teat Guard 2500
IODO SPRAY 2500




Authorisation number


EU-0018496-0002 1-2




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active substance


7553-56-2


231-442-4


0,25




Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)


Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy


Non active substance


68439-50-9


 


2,697





META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC identifier







Identifier


meta SPC 3: Dipping, foaming, spraying concentrated products




1.2.   Suffix to the authorisation number







Number


1-3




1.3.   Product type(s)







Product type(s)


PT03 - Veterinary hygiene (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




Iodine


 


Active substance


7553-56-2


231-442-4


2,5


2,5




Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)


Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy


Non active substance


68439-50-9


 


24,199


24,199




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







Formulation


SL - Soluble concentrate




 


 




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3






Hazard statements


Causes serious eye damage.
May cause damage to organs (thyroid) through prolonged or repeated exposure oral.
Toxic to aquatic life with long lasting effects.
May be corrosive to metals.




Precautionary statements


Keep out of reach of children.
Do not breathe mist.
Do not breathe vapours.
Do not breathe spray.
Wash hands thoroughly after handling.
Wear protective gloves.
Wear protective clothing.
Wear eye protection.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Immediately call a poison center / doctor.
Get medical advice/attention if you feel unwell.
Dispose of contents to in accordance with local/ regional/ national/ international regulations. Dispose of container to in accordance with local/ regional/ national/ international regulations.
Keep only in original container.
Absorb spillage to prevent material damage.




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


Table 4. Use # 1 – Manual or automated dipping, foaming or spraying before milking







Product Type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Bacteria
Yeasts




Field(s) of use


Indoor
Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking




Application method(s)


Dipping, foaming, spraying
Manual or automated disinfection of teats by dipping, foaming or spraying before milking.
Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine




Application rate(s) and frequency


A dilution at 10 % (v/v) should be prepared
Application rate for the diluted product:






—


cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended)










—


sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)










—


goats (2,5 to 6 ml: 2,5 to 4 ml recommended)




Frequency: 2 to 3 times per day




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE JERRYCAN 5, 10, 22 l
HDPE DRUM 60, 120, 220 l
HDPE CONTAINER 1 000  l




4.1.1.   Use-specific instructions for use

Prepare a dilution at 10 % (v/v: 10 ml product, add water up to 100ml) for bactericidal and yeasticidal activity.
Fill the dipping/foaming cup/sprayer manually or automatically with the prepared dilution.
Eliminate all visible dirt before applying the product.
Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.
Let the product act at least one minute.
Use the teat cleaning and wiping method systematically before attaching the milking cluster.
See also general directions for use of meta SPC 3.
4.1.2.   Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.
In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.
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 of meta SPC 3
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 3
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 of meta SPC 3
4.2.   Use description


Table 5. Use # 2 – Manual or automated dipping, foaming or spraying after milking







Product Type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Bacteria
Yeasts
Algae
Viruses




Field(s) of use


Indoor
Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking




Application method(s)


Dipping, foaming, spraying –
Manual or automated disinfection of teats by dipping, foaming or spraying after milking.
Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine




Application rate(s) and frequency


For disinfection of bacteria, yeasts and algae a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) should be prepared.
For disinfection of viruses a dilution at 20 % (v/v: 20 ml product, add water up to 100 ml) should be prepared
Application rate for the diluted product:






—


cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended)










—


sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)










—


goats (2,5 to 6 ml: 2,5 to 4 ml recommended)




Frequency: 2 to 3 times per day




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE JERRYCAN 5, 10, 22 l
HDPE DRUM 60, 120, 220 l
HDPE CONTAINER 1 000  l




4.2.1.   Use-specific instructions for use

Prepare a dilution at 10 % (v/v: 10 ml product, add water up to 100ml) for bactericidal, yeasticidal and algaecidal activity or 20 % (v/v: 20 ml product, add water up to 100 ml) in case virucidal activity is also needed.
Fill the dipping/foaming cup/sprayer manually or automatically with the prepared dilution.
Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat after milking.
Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).
At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
See also general directions for use of meta SPC 3.
4.2.2.   Use-specific risk mitigation measures

For manual spraying applications wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.
In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
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 of meta SPC 3
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 3
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 of meta SPC 3
5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC3
5.1.   Instructions for use

See use-specific instructions for each use.
Always read the label or leaflet before use and follow all the instructions provided.
The product must be brought to a temperature above 20 °C before use.
The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping/foaming cup/sprayer manually or automatically with the prepared dilution.
Where necessary, repeat the application at each milking
Clean the application equipment regularly with warm water.
5.2.   Risk mitigation measures

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.
In case of faintness, get medical advice/attention. Show this safety data sheet to the doctor.
FIRST AID INSTRUCTIONS






—


In the event of inhalation: Bring to fresh air.










—


In the event of contact with the skin: Wash with water.










—


In the event of contact with the eyes: Rinse at once with a soft stream of water for at least 15 minutes, eyes wide open.
Remove contact lenses if present and easy to do. Continue rinsing.
Immediately call a POISON CENTER or doctor/physician.










—


In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.




Refer to the safety data sheet available for professional user: it contains an emergency phone number.
Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.
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 the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 2 years in HDPE
Do not store at a temperature higher than 30 °C.
6.   OTHER INFORMATION
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)


Teat Guard Concentrate 1:4
IODO GUARD CONCENTRATE 1:4




Authorisation number


EU-0018496-0003 1-3




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active substance


7553-56-2


231-442-4


2,5




Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)


Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy


Non active substance


68439-50-9


 


24,199





META SPC 4

1.   META SPC 4 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 4 identifier







Identifier


meta SPC 4: Dipping products reaching virucidal activity – Ready to use




1.2.   Suffix to the authorisation number







Number


1-4




1.3.   Product type(s)







Product type(s)


PT03 - Veterinary hygiene (Disinfectants)




 


 




2.   META SPC 4 COMPOSITION
2.1.   Qualitative and quantitative information on the composition of the meta SPC 4












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Iodine


 


Active substance


7553-56-2


231-442-4


0,5


0,5




Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)


Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy


Non active substance


68439-50-9


 


4,993


4,993




2.2.   Type(s) of formulation of the meta SPC 4







Formulation


AL - Any other liquid




 


 




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4






Hazard statements


Causes serious eye irritation.
Harmful to aquatic life with long lasting effects.




Precautionary statements


Keep out of reach of children.
Wash hands thoroughly after handling.
Wear protective gloves.
Wear protective clothing.
Wear eye protection.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists: Get medical advice/attention.




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


Table 6. Use # 1 – Manual or automated dipping after milking







Product Type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Bacteria
Yeasts
Algae
Viruses




Field(s) of use


Indoor
Disinfection of teats of milk producing animals by dipping after milking




Application method(s)


Dipping -
Manual or automated disinfection of teats by dipping after milking.
Dipping cup or automated dipping machine.




Application rate(s) and frequency








—


cows and buffaloes (3 to 10 ml: 5 ml recommended)










—


sheep (1,5 to 5 ml: 1,5 ml recommended)










—


goats (2,5 to 6 ml: 2,5 ml recommended)




Frequency: 2 to 3 times per day




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE JERRYCAN 5, 10, 22 l
HDPE DRUM 60, 120, 220 l
HDPE CONTAINER 1 000  l




4.1.1.   Use-specific instructions for use

See general directions for use of meta SPC 4
4.1.2.   Use-specific risk mitigation measures

See general directions for use of meta SPC 4
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 of meta SPC 4
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

None: see directions for use meta SPC 4
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 of meta SPC 4
5.   GENERAL DIRECTIONS FOR USE (4) OF THE META SPC 4
5.1.   Instructions for use

Always read the label or leaflet before use and follow all the instructions provided.
The product must be brought to a temperature above 20 °C before use.
The use of a dosing pump for filling the product into the application equipment is recommended. Fill the dipping cup manually or automatically with the ready to use product.
Apply by dipping manually or automatically on animal's teats on the full length of the teat after milking.






—


cows and buffaloes (3 to 10 ml: 5 ml recommended)










—


sheep (1,5 to 5 ml: 1,5 ml recommended)










—


goats (2,5 to 6 ml: 2,5 ml recommended)




Leave the product until next milking. Keep the cows standing until the product has dried (at least 5 minutes).
At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
Where necessary, repeat the application after each milking.
Clean the application equipment regularly with warm water.
5.2.   Risk mitigation measures

Wear eye protection.
In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
5.3.   Particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environment

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.
FIRST AID INSTRUCTIONS






—


In the event of inhalation: Bring to fresh air.










—


In the event of contact with the skin: Wash with water.










—


In the event of contact with the eyes:
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists: Get medical advice/attention.










—


In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.




Refer to the safety data sheet available for professional user: it contains an emergency phone number.
Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.
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 the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 2 years in HDPE
Do not store at a temperature higher than 30 °C.
6.   OTHER INFORMATION
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 4
7.1.   Trade name(s), authorisation number and specific composition of each individual product











Trade name(s)


Teatsan 5000
IODO GUARD 5000




Authorisation number


EU-0018496-0004 1-4




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active substance


7553-56-2


231-442-4


0,5




Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)


Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy


Non active substance


68439-50-9


 


4,993





META SPC 5

1.   META SPC 5 ADMINISTRATIVE INFORMATION
1.1.   Meta SPC 5 identifier







Identifier


meta SPC 5: Dipping, foaming, spraying products 5 500  ppm – Ready to use




1.2.   Suffix to the authorisation number







Number


1-5




1.3.   Product type(s)







Product type(s)


PT03 - Veterinary hygiene (Disinfectants)




 


 




2.   META SPC 5 COMPOSITION
2.1.   Qualitative and quantitative information on the composition of the meta SPC 5












Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Min


Max




Iodine


 


Active substance


7553-56-2


231-442-4


0,55


0,55




Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)


Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy


Non active substance


68439-50-9


 


4,69


4,69




2.2.   Type(s) of formulation of the meta SPC 5







Formulation


AL - Any other liquid




 


 




3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5






Hazard statements


Causes serious eye irritation.
Harmful to aquatic life with long lasting effects.




Precautionary statements


Keep out of reach of children.
Wash hands thoroughly after handling.
Wear protective gloves.
Wear protective clothing.
Wear eye protection.
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists: Get medical advice/attention.




4.   AUTHORISED USE(S) OF THE META SPC 5
4.1.   Use description


Table 7. Use # 1 – Manual or automated dipping, foaming or spraying before milking







Product Type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Bacteria
Yeasts




Field(s) of use


Indoor
Disinfection of teats of milk producing animals by dipping, foaming or spraying before milking




Application method(s)


Dipping, foaming, spraying
Manual or automated disinfection of teats by dipping, foaming or spraying before milking
Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine




Application rate(s) and frequency








—


cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended)










—


sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)










—


goats (2,5 to 6 ml: 2,5 to 4 ml recommended)




Frequency: 2 to 3 times per day




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE JERRYCAN 5, 10, 22 l
HDPE DRUM 60, 120, 220 l
HDPE CONTAINER 1 000  l




4.1.1.   Use-specific instructions for use

Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.
Eliminate all visible dirt before applying the product.
Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat before milking.
Let the product act at least one minute.
Use the teat cleaning and wiping method systematically before attaching the milking cluster.
See also general instructions for use of meta SPC5.
4.1.2.   Use-specific risk mitigation measures

For manual dipping/foaming application: Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/eye protection.
For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.
In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for post-milking disinfection.
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 of meta SPC 5
4.1.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

See general directions for use of meta SPC 5
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 of meta SPC 5
4.2.   Use description


Table 8. Use # 2 – Manual or automated dipping, foaming or spraying after milking







Product Type


PT03 - Veterinary hygiene (Disinfectants)




Where relevant, an exact description of the authorised use


—




Target organism(s) (including development stage)


Bacteria
Yeasts
Algae
Viruses




Field(s) of use


Indoor
Disinfection of teats of milk producing animals by dipping, foaming or spraying after milking




Application method(s)


Dipping, foaming, spraying–
Manual or automated disinfection of teats by dipping, foaming or spraying after milking.
Dipping cup, foaming cup, teat sprayer, automated dipping machine, automated foaming machine or automated spraying machine




Application rate(s) and frequency








—


cows and buffaloes (3 to 10 ml: 5 to 8 ml recommended)










—


sheep (1,5 to 5 ml: 1,5 to 3 ml recommended)










—


goats (2,5 to 6 ml: 2,5 to 4 ml recommended)




Frequency: 2 to 3 times per day




Category(ies) of users


Professional




Pack sizes and packaging material


HDPE JERRYCAN 5, 10, 22 l
HDPE DRUM 60, 120, 220 l
HDPE CONTAINER 1 000  l




4.2.1.   Use-specific instructions for use

Fill the dipping/foaming cup/sprayer manually or automatically with the ready to use product.
Manual or automatic dipping/foaming/spraying on animal's teats on the full length of the teat after milking.
Leave the product until next milking. Keep the cows standing until the product has dried. (at least 5 minutes)
At the next milking, use the teat cleaning and wiping method systematically before attaching the milking cluster.
See also general instructions for use of meta SPC 5.
4.2.2.   Use-specific risk mitigation measures

For manual spraying applications wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information)/protective clothing/eye protection.
In case a combination of pre- and post-milking disinfection is necessary, using another biocidal product not containing iodine has to be considered for pre-milking disinfection.
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 of meta SPC 5
4.2.4.   Where specific to the use, the instructions for safe disposal of the product and its packaging

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

See use-specific instructions for each use.
Always read the label or leaflet before use and follow all the instructions provided.
The product must be brought to a temperature above 20 °C before use.
The use of a dosing pump for filling the product into the application equipment is recommended.
Where necessary repeat the application at each milking.
Clean the application equipment regularly with warm water.
5.2.   Risk mitigation measures

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

Take the contaminated clothes and shoes off immediately. Wash them before wearing them again.
FIRST AID INSTRUCTIONS






—


In the event of inhalation: Bring to fresh air.










—


In the event of contact with the skin: Wash with water.










—


In the event of contact with the eyes:
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists: Get medical advice/attention.










—


In the event of ingestion: Rinse mouth. Do NOT induce vomiting. Get medical advice.




Refer to the safety data sheet available for professional user: it contains an emergency phone number.
Large spillage: Mark out, dyke up with an inert absorbant and pump in an emergency tank. Keep in suitable, properly labelled and closed containers for disposal. Never return spills in original containers for re-use.
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 the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.
The paper towels used for removing the product and drying the teats are disposed in the normal and domestic waste.
5.5.   Conditions of storage and shelf-life of the product under normal conditions of storage

Shelf life: 2 years in HDPE
Do not store at a temperature higher than 30 °C.
6.   OTHER INFORMATION
7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 5
7.1.   Trade name(s), authorisation number and specific composition of each individual product











Trade name(s)


Teat Guard 5500
IODO SPRAY 5500




Authorisation number


EU-0018496-0005 1-5




Common name


IUPAC name


Function


CAS number


EC number


Content (%)




Iodine


 


Active substance


7553-56-2


231-442-4


0,55




Alcohols, C12-14, ethoxylated (11 mol EO average molar ratio)


Poly(oxy-1,2-ethanediyl), -C12-14-(even numbered)-alkyl-hydroxy


Non active substance


68439-50-9


 


4,69






(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC3.

(4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC4.

(5)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2.