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Commission Implementing Regulation (EU) 2018/1288 of 24 September 2018 granting a Union authorisation for the biocidal product family Prodhynet's iodine based products (Text with EEA relevance.)

Commission Implementing Regulation (EU) 2018/1288of 24 September 2018granting a Union authorisation for the biocidal product family Prodhynet'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 productsOJ L 167, 27.6.2012, p. 1., and in particular Article 44(5) thereof,Whereas:(1)On 3 August 2015, Prodhynet SA 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 414/2013Commission 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). for authorisation of a same biocidal product family, as referred to in Article 1 of Regulation (EU) No 414/2013, named Prodhynet'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-YK019030-42 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) 2017/2100Commission 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). will become applicable, the Commission will consider the need to review 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 opinionECHA opinion of 25 January 2018 on the Union authorisation of the same biocidal product family PRODHYNET'S iodine based products (UBP-C-1177988-02-00/F)., including the draft summary of the biocidal product characteristics ("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 Commission Implementing Regulation (EU) No 354/2013Commission 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)., and that based on the assessment of the above-mentioned 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 6 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 1A Union authorisation is granted to Prodhynet SA for the same biocidal product family Prodhynet's iodine based products with authorisation number EU-0018497-0000.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 2This 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 CommissionThe PresidentJean-Claude JunckerANNEXSummary of product characteristics for a biocidal product familyPRODHYNET's iodine based productsProduct type 3 - Veterinary hygiene (Disinfectants)Authorisation number: EU-0018497-0000R4BP asset number: EU-0018497-0000PART IFIRST INFORMATION LEVEL1.ADMINISTRATIVE INFORMATION1.1.Family name

Name	PRODHYNET'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	PRODHYNET SA
	Address	11 Avenue des châtelets, 22440, PLOUFRAGAN, France
Authorisation number	EU-0018497-0000
R4BP asset number	EU-0018497-0000
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	PRODHYNET SA
Address of manufacturer	11, Avenue des Châtelets 22440 PLOUFRAGAN France
Location of manufacturing sites	PRODHYNET SA - 11, Avenue des Châtelets 22440 PLOUFRAGAN France

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

Active substance	Iodine
Name of manufacturer	COSAYACH: SCM Cía. Cosayach Minera Negreiros, Rut. No 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 ChileNueva Victoria (NV) Route 5 North, Km 1925 Pozo Almonte Chile

2.PRODUCT FAMILY COMPOSITION AND FORMULATION2.1.Qualitative and quantitative information on the composition of the family

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	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 liquidSL - Soluble concentrate

PART IISECOND INFORMATION LEVEL - META SPC(S)META SPC 11.META SPC 1 ADMINISTRATIVE INFORMATION1.1.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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 1

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	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 14.1.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)	BacteriaYeastsAlgae
Field(s) of use	IndoorDisinfection 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 LHDPE DRUM 60, 120, 220 LHDPE CONTAINER 1000 L

4.1.1.Use-specific instructions for useSee general directions for use of meta SPC 14.1.2.Use-specific risk mitigation measuresSee general directions for use of meta SPC 14.1.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use of meta SPC 14.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingNone: see directions for use meta SPC 14.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 15.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC1. OF THE META SPC 15.1.Instructions for useAlways 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 measuresWear 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 environmentTake the contaminated clothes and shoes off immediately. Wash them before wearing them again.FIRST AID INSTRUCTIONSIn 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 packagingAt 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 storageShelf life: 2 years in HDPEDo not store at a temperature higher than 30 °C.6.OTHER INFORMATION7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 17.1.Trade name(s), authorisation number and specific composition of each individual product

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Trade name(s)	IODO EP25IODOGELPRO TI-N
Authorisation number	EU-0018497-0001 1-1
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 21.META SPC 2 ADMINISTRATIVE INFORMATION1.1.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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 2

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	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 24.1.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)	BacteriaYeasts
Field(s) of use	IndoorDisinfection 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 milkingDipping 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 LHDPE DRUM 60, 120, 220 LHDPE CONTAINER 1000 L

4.1.1.Use-specific instructions for useEliminate 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 measuresFor 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 environmentSee general directions for use of meta SPC 24.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use of meta SPC 24.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 24.2.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)	BacteriaYeastsAlgae
Field(s) of use	IndoorDisinfection 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 milkingDipping 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 LHDPE DRUM 60, 120, 220 LHDPE CONTAINER 1000 L

4.2.1.Use-specific instructions for useManual 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 measuresFor 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 environmentSee general directions for use of meta SPC 24.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use of meta SPC 24.2.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 25.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC2. OF THE META SPC 25.1.Instructions for useSee 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 milkingClean the application equipment regularly with warm water.5.2.Risk mitigation measuresSee 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 environmentTake the contaminated clothes and shoes off immediately. Wash them before wearing them again.FIRST AID INSTRUCTIONSIn 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 packagingAt 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 storageShelf life: 2 years in HDPEDo not store at a temperature higher than 30 °C.6.OTHER INFORMATION7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 27.1.Trade name(s), authorisation number and specific composition of each individual product

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Trade name(s)	IODO FL25PRO ROBO I-N
Authorisation number	EU-0018497-0002 1-2
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 31.META SPC 3 ADMINISTRATIVE INFORMATION1.1.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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 3

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	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 34.1.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)	BacteriaYeasts
Field(s) of use	IndoorDisinfection 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 preparedApplication 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 3ml 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 LHDPE DRUM 60, 120, 220 LHDPE CONTAINER 1000 L

4.1.1.Use-specific instructions for usePrepare a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) 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 measuresFor 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 environmentSee general directions for use of meta SPC 34.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use of meta SPC 34.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 34.2.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)	BacteriaYeastsAlgaeViruses
Field(s) of use	IndoorDisinfection 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 preparedApplication 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 LHDPE DRUM 60, 120, 220 LHDPE CONTAINER 1000 L

4.2.1.Use-specific instructions for usePrepare a dilution at 10 % (v/v: 10 ml product, add water up to 100 ml) 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 measuresFor 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 environmentSee general directions for use of meta SPC 34.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use of meta SPC 34.2.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 35.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC3. OF THE META SPC 35.1.Instructions for useSee 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 milkingClean the application equipment regularly with warm water.5.2.Risk mitigation measuresSee 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 environmentTake 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 INSTRUCTIONSIn 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 packagingAt 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 storageShelf life: 2 years in HDPEDo not store at a temperature higher than 30 °C.6.OTHER INFORMATION7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 37.1.Trade name(s), authorisation number and specific composition of each individual product

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Trade name(s)	PRMXIODOSE
Authorisation number	EU-0018497-0003 1-3
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 41.META SPC 4 ADMINISTRATIVE INFORMATION1.1.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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 4

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	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 44.1.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)	BacteriaYeastsAlgaeViruses
Field(s) of use	IndoorDisinfection 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 LHDPE DRUM 60, 120, 220 LHDPE CONTAINER 1000 L

4.1.1.Use-specific instructions for useSee general directions for use of meta SPC 44.1.2.Use-specific risk mitigation measuresSee general directions for use of meta SPC 44.1.3.Where specific to the use, the particulars of likely direct or indirect effects, first aid instructions and emergency measures to protect the environmentSee general directions for use of meta SPC 44.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use of meta SPC 44.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 45.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC4. OF THE META SPC 45.1.Instructions for useAlways 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 measuresWear 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 environmentTake the contaminated clothes and shoes off immediately. Wash them before wearing them again.FIRST AID INSTRUCTIONSIn 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 packagingAt 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 storageShelf life: 2 years in HDPEDo not store at a temperature higher than 30 °C.6.OTHER INFORMATION7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 47.1.Trade name(s), authorisation number and specific composition of each individual product

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Trade name(s)	AGRI IODE EPAIS SHYGIA IODE EPAIS SIODE EPAISNETAIODE EPAIS STREMPAGE EPAIS IODE SIODO EP50ADIEL IODE EPAISLATI IODEPRO TIPROXA IODE EPAIS SBREIZH-IODE EPAIS SBRETAIODE EPAISDR16PLUSAIOD EPAISHELIO FIRST EPTECNO FIRSTLACTOIODE EPAISMAG IODE EPAIS S
Authorisation number	EU-0018497-0004 1-4
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 51.META SPC 5 ADMINISTRATIVE INFORMATION1.1.Meta SPC 5 identifier

Identifier

meta SPC 5: Dipping, foaming, spraying products 5500 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 COMPOSITION2.1.Qualitative and quantitative information on the composition of the meta SPC 5

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Common name	IUPAC name	Function	CAS number	EC number	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 54.1.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)	BacteriaYeasts
Field(s) of use	IndoorDisinfection 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 milkingDipping 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 LHDPE DRUM 60, 120, 220 LHDPE CONTAINER 1000 L

4.1.1.Use-specific instructions for useFill 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 measuresFor 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 environmentSee general directions for use of meta SPC 54.1.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use of meta SPC 54.1.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 54.2.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)	BacteriaYeastsAlgaeViruses
Field(s) of use	IndoorDisinfection 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 LHDPE DRUM 60, 120, 220 LHDPE CONTAINER 1000 L

4.2.1.Use-specific instructions for useFill 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 measuresFor 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 environmentSee general directions for use of meta SPC 54.2.4.Where specific to the use, the instructions for safe disposal of the product and its packagingSee general directions for use of meta SPC 54.2.5.Where specific to the use, the conditions of storage and shelf-life of the product under normal conditions of storageSee general directions for use of meta SPC 55.GENERAL DIRECTIONS FOR USEInstructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC5. OF THE META SPC 55.1.Instructions for useSee 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 milkingClean the application equipment regularly with warm water.5.2.Risk mitigation measuresSee 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 environmentTake the contaminated clothes and shoes off immediately. Wash them before wearing them again.FIRST AID INSTRUCTIONSIn 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 packagingAt 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 storageShelf life: 2 years in HDPEDo not store at a temperature higher than 30 °C.6.OTHER INFORMATION7.THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 57.1.Trade name(s), authorisation number and specific composition of each individual product

Common name	IUPAC name	Function	CAS number	EC number	Content (%)
Trade name(s)	AGRI IODE FLUIDEHYGIA IODE FLUIDEIODE FLUIDEIOSPRAY FLUIDEPULVE IODEIODO FL55IODOLINADIEL IODE FLUIDEBOVI IODE SPRAYPRO ROBO IPROXA IODE FLUIDEHELIODE FLUIDETECNO FLUIDEDR15GANAIODE FLUIDEPLUSAIODPROTECTION FLUIDE IODEBREIZH-IODE FLUIDEBRETAIODE LQIODE NET FLUIDELACTOIODE FLUIDEMAG IODE FLUIDENETAIODE FLUIDENETAIODE
Authorisation number	EU-0018497-0005 1-5
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