Commission Implementing Regulation (EU) 2019/1844 of 22 October 2019 granting a Union authorisation for the biocidal product family BPF_Iodine_VET (Text with EEA relevance)Text with EEA relevance

• Published date: 05 November 2019
• Subject Matter: Internal market - Principles
• Official Gazette Publication: Official Journal of the European Union, L 283, 5 November 2019

02019R1844 — EN — 08.07.2021 — 001.001

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►B COMMISSION IMPLEMENTING REGULATION (EU) 2019/1844 of 22 October 2019 granting a Union authorisation for the biocidal product family ‘BPF_Iodine_VET’ (Text with EEA relevance) (OJ L 283 5.11.2019, p. 1)

Amended by:

		Official Journal
		No	page	date
►M1	COMMISSION IMPLEMENTING REGULATION (EU) 2021/977 of 7 June 2021	L 216	26	18.6.2021

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▼B

COMMISSION IMPLEMENTING REGULATION (EU) 2019/1844

of 22 October 2019

granting a Union authorisation for the biocidal product family ‘BPF_Iodine_VET’

(Text with EEA relevance)

Article 1

A Union authorisation with authorisation number EU-0020540-0000 is granted to Applied Biocide GmbH for the making available on the market and use of the biocidal product family ‘BPF_Iodine_VET’, in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 25 November 2019 until 31 October 2029.

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.

▼M1

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ANNEX

Summary of product characteristics for a biocidal product family

BPF_Iodine_VET

Product type 3 – Veterinary hygiene (Disinfectants)

Authorisation number: EU-0020540-0000

R4BP asset number: EU-0020540-0000

PART I

FIRST INFORMATION LEVEL

1. ADMINISTRATIVE INFORMATION

1.1. Family name

Name BPF_Iodine_VET

1.2. Product type(s)

Product type(s) PT03 – Veterinary hygiene (Disinfectants)

1.3. Authorisation holder

Name and address of the authorisation holder	Name	Applied Biocide GmbH
	Address	Siemensstraße 42, 59199 Bönen, Germany
Authorisation number	EU-0020540-0000
R4BP asset number	EU-0020540-0000
Date of the authorisation	25 November 2019
Expiry date of the authorisation	31 October 2029

1.4. Manufacturer(s) of the biocidal products

Name of manufacturer	THESEO Deutschland GmbH
Address of manufacturer	Kolpingstrasse 4, 49835 Wietmarschen Germany
Location of manufacturing sites	Kolpingstrasse 4, 49835 Wietmarschen Germany

Name of manufacturer	FINK TEC GmbH
Address of manufacturer	Oberster Kamp 23, 59069 Hamm Germany
Location of manufacturing sites	Oberster Kamp 23, 59069 Hamm Germany

Name of manufacturer	I.R.C.A. SERVICE S.p.A.
Address of manufacturer	S.S. Cremasca 591 no. 10, 24040 Fornovo S. Giovanni (BG) Italy
Location of manufacturing sites	S.S. Cremasca 591 no. 10, 24040 Fornovo S. Giovanni (BG) Italy

Name of manufacturer	Laboratorios Maymó S.A.
Address of manufacturer	Via Augusta, 302, 08017 Barcelona Spain
Location of manufacturing sites	Via Augusta, 302, 08017 Barcelona Spain

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

Active substance	Iodine
Name of manufacturer	Cosayach S.A. Compania de Salitre y Yodo
Address of manufacturer	Amunátegui 178, 7th Floor, 8320000 Santiago Chile
Location of manufacturing sites	S.C.M. Cosayach Cala Cala, 1180000 Pozo Almonte Chile Chile

Active substance	Iodine
Name of manufacturer	ACF Minera S.A.
Address of manufacturer	San Martin 499, 1100000 Iquique Chile
Location of manufacturing sites	Lagunas mine, 1180000 Pozo Almonte Chile

Active substance	Iodine
Name of manufacturer	Sociedad Quimica y Minera SA
Address of manufacturer	Los Militares 4290, 7550000 Las Condes Chile
Location of manufacturing sites	Nueva Victoria, 1180000 Pozo Almonte Chile Pedro de Valdivia, 1240000 Antofagasta 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	0,1	3,0
Phosphoric Acid	Trihydroxidooxidophosphorus phosphoric acid	Non-active substance	7664-38-2	231-633-2	0,0	10,0
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched	Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched	Non-active substance	69011-36-5	500-241-6	0,0	31,8
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate	Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate	Non-active substance	68439-46-3	614-482-0	0,0	31,8

2.2. Type(s) of formulation

Formulation(s) meta SPC 1-5: AL – any other liquid meta SPC 6-8: SL – soluble concentrate

PART II

SECOND INFORMATION LEVEL – META SPC(S)

META SPC 1

1. META SPC 1 ADMINISTRATIVE INFORMATION

1.1. Meta SPC 1 identifier

Identifier Meta SPC 1

1.2. Suffix to the authorisation number

Number 1-1

1.3. Product type(s)

Product type(s) 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	0,15	0,15
Phosphoric Acid	Trihydroxidooxidophosphorus phosphoric acid	Non-active substance	7664-38-2	231-633-2	0,0	0,0
Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched	Poly(oxy-1,2-ethanediyl).alpha.-tridecyl-.omega.-hydroxy-,branched	Non-active substance	69011-36-5	500-241-6	0,0	0,0
Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate	Isotridecanol, ethoxylated 90 %, C 9-11 Alcohol Ethoxylate	Non-active substance	68439-46-3	614-482-0	0,0	0,0

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

Formulation(s) AL – any other liquid

3. HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

Hazard statements	May be corrosive to metals.
Precautionary statements	Keep only in original packaging. Absorb spillage to prevent material damage. Store in corrosive resistant container with a resistant inner liner.

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

4.1. Use description

Table 1. Use # 1 – Veterinary hygiene – animal husbandry – teat disinfectant – professional – indoors – spraying (post 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
Application method(s)	Open system: spray treatment
	Spraying: Manual and automated non-medical disinfection of teats with a ready-to-use spray (on cows, post-milking)
Application rate(s) and frequency	Application rate: 10-15 mL per cow
	Application frequency: During lactation period: manual: 2 applications per day (post-milking) automated: 3 applications per day (post-milking) During dry period: 1 application per day
Category(ies) of users	Professional
Pack sizes and packaging material	Bottle high-density polyethylene (HDPE): 1 liter, cap is made of PP Jerry can HDPE: 5 – 60 liters Drum HDPE: 200 liters IBC HDPE: 600 – 1000 liters

4.1.1. Use-specific instructions for use

…

4.1.2. Use-specific risk mitigation measures

…

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

…

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

…

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

…

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.

Immediately after each cow has been milked, spray the entire surface of each teat with the solution. Leave the product until next milking. Do not clean the teats directly after disinfection.

Keep the cows standing until the product has dried (at least 5 minutes).

Product can be applied manually or by means of automatic teat sprayer.

Before the next milking the teats have to be cleaned, preferably with one new wet cloth per cow.

Application frequency must not exceed two applications per cow and day considering manual spraying and must not exceed three applications per cow and day considering automatic teat sprayer (post-milking).

5.2. Risk mitigation measures

Keep out of reach of children.

Wear protective chemical resistant gloves, coated coverall and boots during product handling and application phase (material to be specified by the authorisation holder in the product information).

In case a combination of pre- and post-milking disinfection is...