COMMISSION IMPLEMENTING REGULATION (EU) 2020/1187

of 7 August 2020

granting a Union authorisation for the biocidal product family ‘Iodine based products – CID LINES NV’

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the first subparagraph of Article 44(5) thereof,

Whereas:

(1) On 13 August 2015, CID LINES NV submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Iodine based products – CID LINES NV’ of product-types 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-BY019142-30 in the Register for Biocidal Products.

(2) ‘Iodine based products – CID LINES NV’ contains iodine including polyvinylpyrrolidone iodine, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012. Taking into account the intrinsic properties of the active substance, and the scientific criteria for the determination of endocrine-disrupting properties set out in Commission Delegated Regulation (EU) 2017/2100 (2), the Commission is carrying out a 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 consider whether the Union authorisations for products containing the active substance have to be cancelled or amended in accordance with Article 48 of Regulation (EU) No 528/2012.

(3) On 28 May 2019, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

(4) On 17 January 2020, the Agency submitted to the Commission an opinion (3), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Iodine based products – CID LINES NV’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5) The opinion concludes that ‘Iodine based products – CID LINES NV’ is a biocidal product family within the meaning of Article 3(1)(s) of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

(6) On 4 February 2020 the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(7) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Iodine based products – CID LINES NV’.

(8) According to the opinion of the Agency, as regards the non-active substances sodium iodide and sodium iodate contained in ‘Iodine based products – CID LINES NV’, it was not possible to conclude whether they meet the scientific criteria for the determination of endocrine-disrupting properties set out in Delegated Regulation (EU) 2017/2100 within the period for the evaluation of the application. Further examination of sodium iodide and sodium iodate should therefore take place. If it is concluded that sodium iodide or sodium iodate or both are considered as having endocrine-disrupting properties, the Commission will consider whether to cancel or amend the Union authorisation for ‘Iodine based products – CID LINES NV’ in accordance with Article 48 of Regulation (EU) No 528/2012.

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

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0022265-0000 is granted to CID LINES NV for the making available on the market and use of the biocidal product family ‘Iodine based products – CID LINES NV’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 3 September 2020 until 31 August 2030.

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, 7 August 2020.

For the Commission

The President

Ursula VON DER LEYEN

(1)  

OJ L 167, 27.6.2012, p. 1

.

(2)  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

).

(3)  ECHA opinion of 11 December 2019 on the Union authorisation of ‘Iodine based products – CID LINES NV’ (ECHA/BPC/237/2019).

ANNEX

Summary of product characteristics for a biocidal product family

Iodine based products – CID LINES NV

Product type 3 – Veterinary hygiene (Disinfectants)

Product type 4 – Food and feed area (Disinfectants)

Authorisation number: EU-0022265-0000

R4BP asset number: EU-0022265-0000

PART I

FIRST INFORMATION LEVEL

1.   

ADMINISTRATIVE INFORMATION

1.1.   

Family name

1.2.   

Product type(s)

1.3.   

Authorisation holder

1.4.   

Manufacturer(s) of the biocidal products

1.5.   

Manufacturer(s) of the active substance(s)

2.   

PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   

Qualitative and quantitative information on the composition of the family

2.2.   

Type(s) of formulation

PART II

SECOND INFORMATION LEVEL – META SPC(S)

META SPC 1

1.   

META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 1 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 1 COMPOSITION

2.1.   

Qualitative and quantitative information on the composition of the meta SPC 1

2.2.   

Type(s) of formulation of the meta SPC 1

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

4.   

AUTHORISED USE(S) OF THE META SPC 1

4.1.   

Use description

Table 1. Use # 1 – PT3– Concentrated Teat disinfectant, post-milking, Iodine

4.1.1.   

Use-specific instructions for use

See general directions for use.

4.1.2.   

Use-specific risk mitigation measures

See general directions for use.

4.1.3.   

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

See general directions for use.

4.1.4.   

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

See general directions for use.

4.1.5.   

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

See general directions for use.

5.   

GENERAL DIRECTIONS FOR USE

 (1)

OF THE META SPC 1

5.1.   

Instructions for use

The product must be diluted before use with clean potable water to allow a final concentration of iodine of 0,3 % (200 ml product, add water up to 1 L).

The diluted product must be brought to a temperature above 20 °C before use.

Assume 5 mL diluted product per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended. Use gloves and eye protection during the dilution step. The diluted product can be kept and used during 1 week but do not prepare more fluid than necessary.

Apply the diluted product on the teats with a manual sprayer or with an automatic sprayer.

The product should be used directly after milking 2 times per day by using a manual sprayer and 3 times per day when using a robot (automatic sprayer).

Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

5.2.   

Risk mitigation measures

— For mixing and loading of the product: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye/face protection.

— For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

— If a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

— Keep out of reach of children.

5.3.   

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

After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.

If medical advice is needed, have product container or label at hand.

After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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.

 

—  

—  

—  

 

5.5.   

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

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

META SPC 2

1.   

META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 2 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 2 COMPOSITION

2.1.   

Qualitative and quantitative information on the composition of the meta SPC 2

2.2.   

Type(s) of formulation of the meta SPC 2

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

4.   

AUTHORISED USE(S) OF THE META SPC 2

4.1.   

Use description

Table 2. Use # 1 – PT3– RTU Teat disinfectant, post-milking, Iodine

4.1.1.   

Use-specific instructions for use

See general directions for use.

4.1.2.   

Use-specific risk mitigation measures

See general directions for use.

4.1.3.   

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

See general directions for use.

4.1.4.   

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

See general directions for use.

4.1.5.   

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

See general directions for use.

5.   

GENERAL DIRECTIONS FOR USE

 (2)

OF THE META SPC 2

5.1.   

Instructions for use

The product must be brought to a temperature above 20 °C before use.

Apply the product by dipping or by spraying:

— By dipping:

Apply the product with a dip cup. Wash the dip cup with water after use.

— By spraying:

Apply the product with a manual sprayer or with an automatic sprayer.

Do not prepare more fluid than necessary; assume 5 mL solution per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended.

The product should be used immediately after each milking: 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

5.2.   

Risk mitigation measures

— For manual dipping application: No special protection equipment is recommended under normal conditions of use.

— For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information.

— If 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.

— Keep out of reach of children.

5.3.   

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit.

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.

 

—  

—  

—  

 

5.5.   

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

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

7.2.   

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

META SPC 3

1.   

META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 3 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 3 COMPOSITION

2.1.   

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

2.2.   

Type(s) of formulation of the meta SPC 3

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

4.   

AUTHORISED USE(S) OF THE META SPC 3

4.1.   

Use description

Table 3. Use # 1 – PT3- RTU Udder disinfectant, Iodine

4.1.1.   

Use-specific instructions for use

See general directions for use.

4.1.2.   

Use-specific risk mitigation measures

See general directions for use.

4.1.3.   

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

See general directions for use.

4.1.4.   

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

See general directions for use.

4.1.5.   

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

See general directions for use.

5.   

GENERAL DIRECTIONS FOR USE

 (3)

OF THE META SPC 3

5.1.   

Instructions for use

For disinfection of the skin:

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.

Apply by spraying on the animals’ intact skin for a topical disinfection:

— on the udder of dairy and beef cattle before calving: 1 spray on each teat (equivalent to 4,8 mL per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing at least 5 minutes).

— on the udder of sows before farrowing: Assume 15 to 20 mL per animal, once one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Only for use on intact skin.

Do not mix with other chemicals.

5.2.   

Risk mitigation measures

For manual spraying application on cows and sows: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

In case a combination of post-milking disinfection of cows and skin disinfection of cows is necessary, an iodine based product shall not be used by the same person to perform both disinfections.

Keep out of reach of children.

5.3.   

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit

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.

 

—  

—  

—  

 

5.5.   

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

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

7.2.   

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

META SPC 4

1.   

META SPC 4 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 4 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 4 COMPOSITION

2.1.   

Qualitative and quantitative information on the composition of the meta SPC 4

2.2.   

Type(s) of formulation of the meta SPC 4

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 4

4.   

AUTHORISED USE(S) OF THE META SPC 4

4.1.   

Use description

Table 4. Use # 1 – PT3– RTU Teat disinfectant, Post-milking, Iodine

4.1.1.   

Use-specific instructions for use

For disinfection of the teats:

The product must be brought to a temperature above 20 °C before use.

— By dipping: Apply the product on the teats with a dip cup. Wash the dip cup with water after use.

— By spraying: Apply the product on the teats with a manual sprayer or with an automatic sprayer.

Do not prepare more fluid than necessary. Assume 5 mL solution per cow per treatment. The use of a dosing pump for filling the product into the application equipment is recommended.

The product should be used directly after milking by using a dipping cup or a manual or automatic sprayer. Ensure that the teat is completely covered to three quarters of its length.

The product is applied after milking: 2 times per day for manual spraying and 3 times per day for manual dipping and spraying with robot.

Let the product dry on the teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

4.1.2.   

Use-specific risk mitigation measures

— For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

— For manual dipping application: no Personal Protection Equipment (PPE) is necessary for safe use.

— If a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered for pre-milking disinfection.

— Keep out of reach of children.

4.1.3.   

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

See general directions for use.

4.1.4.   

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

See general directions for use.

4.1.5.   

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

See general directions for use.

4.2.   

Use description

Table 5. Use # 2 – PT3- RTU Udder disinfectant, Iodine

4.2.1.   

Use-specific instructions for use

For disinfection of the skin:

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.

Apply by spraying on the animals’ intact skin for a topical disinfection:

— on the udder of dairy and beef cattle before calving: 1 spray on each teat (equivalent to 4,8 mL per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

— on the udder of sows before farrowing: Assume 15 to 20 mL per animal, once one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Let the product dry on skin.

Only for use on intact skin.

Do not mix with other chemicals.

4.2.2.   

Use-specific risk mitigation measures

— For manual spraying application on cows and sows: no PPE is necessary for safe use.

— Keep out of reach of children.

4.2.3.   

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

See general directions for use.

4.2.4.   

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

See general directions for use.

4.2.5.   

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

See general directions for use.

5.   

GENERAL DIRECTIONS FOR USE

 (4)

OF THE META SPC 4

5.1.   

Instructions for use

See use-specific instructions for use.

5.2.   

Risk mitigation measures

See use-specific risk mitigation measures

5.3.   

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit.

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.

 

—  

—  

—  

 

5.5.   

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

Keep only in the original container in a cool, well ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

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

META SPC 5

1.   

META SPC 5 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 5 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 5 COMPOSITION

2.1.   

Qualitative and quantitative information on the composition of the meta SPC 5

2.2.   

Type(s) of formulation of the meta SPC 5

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 5

4.   

AUTHORISED USE(S) OF THE META SPC 5

4.1.   

Use description

Table 6. Use # 1 – PT3 – RTU Teat disinfectant, post milking, PVP-Iodine

4.1.1.   

Use-specific instructions for use

See general directions for use.

4.1.2.   

Use-specific risk mitigation measures

See general directions for use.

4.1.3.   

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

See general directions for use.

4.1.4.   

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

See general directions for use.

4.1.5.   

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

See general directions for use.

5.   

GENERAL DIRECTIONS FOR USE

 (5)

OF THE META SPC 5

5.1.   

Instructions for use

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.

Apply the product by dipping or by spraying:

— By dipping:

Apply the product with a dip cup. Wash the dip cup with water after use.

— By spraying:

Apply the product with a manual sprayer or with an automatic sprayer.

Do not prepare more fluid than necessary. Assume 5 mL solution per cow per treatment.

The product should be used immediately after each milking, two times per day for manual spraying and 3 times per day for manual dipping and spraying with robot. Ensure that the teat is completely covered to three quarters of its length. Let the product dry on teats. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Do not mix with other chemicals.

5.2.   

Risk mitigation measures

— For manual spraying application: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information.

— For manual dipping application: no PPE is necessary for safe use.

— If 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.

— Keep out of reach of children.

5.3.   

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit.

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.

 

—  

—  

—  

 

5.5.   

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 18 months.

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

7.2.   

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

META SPC 6

1.   

META SPC 6 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 6 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 6 COMPOSITION

2.1.   

Qualitative and quantitative information on the composition of the meta SPC 6

2.2.   

Type(s) of formulation of the meta SPC 6

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 6

4.   

AUTHORISED USE(S) OF THE META SPC 6

4.1.   

Use description

Table 7. Use # 1 – PT3- RTU Udder disinfectant PVP-Iodine

4.1.1.   

Use-specific instructions for use

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.

— Dairy and beef cattle: Apply the product by spraying on the udder before calving (1 spray/teat equivalent to 4,8 mL per application). Disinfection takes place once, one day before calving and once, one day after calving. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

— Sows, on the udder before farrowing: Assume 15 to 20 mL per animal. Disinfection takes place once, one day before farrowing and once every day during 4 days after farrowing. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the animal standing for at least 5 minutes).

Only for use on intact skin.

Do not mix with other chemicals.

4.1.2.   

Use-specific risk mitigation measures

— For manual spraying application on cows and sows: Wear chemical resistant gloves (glove material to be specified by the authorisation holder within the product information).

— In case a combination of post-milking disinfection of cows and skin disinfection of cows is necessary, an iodine based product shall not be used by the same person to perform both disinfections.

— Keep out of reach of children.

4.1.3.   

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

See general directions for use.

4.1.4.   

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

See general directions for use.

4.1.5.   

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

See general directions for use.

5.   

GENERAL DIRECTIONS FOR USE

 (6)

OF THE META SPC 6

5.1.   

Instructions for use

See use-specific instructions for use.

5.2.   

Risk mitigation measures

See use-specific risk mitigation measures.

5.3.   

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

After eye contact: Rinse immediately with water.

After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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.

 

—  

—  

—  

 

5.5.   

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   

OTHER INFORMATION

7.   

THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 6

7.1.   

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

META SPC 7

1.   

META SPC 7 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 7 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 7 COMPOSITION

2.1.   

Qualitative and quantitative information on the composition of the meta SPC 7

2.2.   

Type(s) of formulation of the meta SPC 7

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 7

4.   

AUTHORISED USE(S) OF THE META SPC 7

4.1.   

Use description

Table 8. Use # 1 – PT 4 – Concentrated Surface disinfectant in kitchens and in food industry, Iodine

4.1.1.   

Use-specific instructions for use

Use in professional kitchens (PT4) and in food industry (PT4):

The product must be diluted with water before use (according to the table below).

Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.

The product is used in professional kitchens (surface disinfection): Frequency is once per day.

The product is used in food industry (surface disinfection): Frequency is once per day.

Use at room temperature.

Apply the product by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 15 minutes and rinse the surfaces afterwards with clean water.

Do not mix with other chemicals.

Do not prepare more fluid than necessary.

4.1.2.   

Use-specific risk mitigation measures

— During pouring and pumping of the concentrated product: Wear chemical resistant gloves (material to be specified by the authorisation holder within the product information) and eye/face protection.

— During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) (glove and coverall material to be specified by the authorisation holder within the product information).

— Keep out of reach of children.

— The general public and animals should be kept away from treated areas until surfaces are dry.

4.1.3.   

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

See general directions for use.

4.1.4.   

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

See general directions for use.

4.1.5.   

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

See general directions for use.

4.2.   

Use description

Table 9. Use # 2 – PT3 – Concentrated Surface disinfectant for veterinary use, Iodine

4.2.1.   

Use-specific instructions for use

Use in veterinary field (PT3), surface disinfection:

The product should be diluted with water before use (according to table below).

Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.

The product is used to disinfect animal housings of pigs, cows and poultry.

Apply the product by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 30 minutes. Animal housing must be empty of animals during application and animals can re-enter 24h after the end of the application.

Do not mix with other chemicals.

Do not prepare more fluid than necessary.

4.2.2.   

Use-specific risk mitigation measures

— During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coated coverall (material to be specified by the authorisation holder within the product information) and eye/face protection.

— During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product (glove and coverall material to be specified by the authorisation holder within the product information).

— Only use one kind of Iodine-containing product per day.

— Due to potential concern for human health the same professional user shall not carry out animal house disinfection more than 3 times per month and shll not use Iodine products for other purposes during that period.

— Due to potential concern for animal health, disinfection of stables should not be carried out more than once per year or once per lifetime for calves and pigs. Feeding troughs must be covered during application.

— Keep out of reach of children.

— The general public and animals should be kept away from treated areas until surfaces are dry.

4.2.3.   

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

See general directions for use.

4.2.4.   

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

See general directions for use.

4.2.5.   

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

See general directions for use.

5.   

GENERAL DIRECTIONS FOR USE

 (7)

OF THE META SPC 7

5.1.   

Instructions for use

See use-specific instructions for use.

5.2.   

Risk mitigation measures

See use-specific risk mitigation measures.

5.3.   

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

After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.

If medical advice is needed, have product container or label at hand.

After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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.

 

—  

—  

—  

 

5.5.   

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   

OTHER INFORMATION

7.   

THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 7

7.1.   

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

META SPC 8

1.   

META SPC 8 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 8 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 8 COMPOSITION

2.1.   

Qualitative and quantitative information on the composition of the meta SPC 8

2.2.   

Type(s) of formulation of the meta SPC 8

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 8

4.   

AUTHORISED USE(S) OF THE META SPC 8

4.1.   

Use description

Table 10. Use # 1 – PT4 – Concentrated Surface disinfectant in kitchens and in food industry, Iodine

4.1.1.   

Use-specific instructions for use

— Use in professional kitchens (PT4) and in food industry (PT4):

— The product must be diluted with water before use (according to table below).

— Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.

— The product is used in

professional kitchens

(surface disinfection): Frequency is once per day.

— The product is used in food industry (surface disinfection): Frequency is once per day.

— Use at room temperature.

— The product is applied by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 15 minutes, and rinse the surfaces afterwards with clean water.

Do not mix with other chemicals.

Do not prepare more fluid than necessary.

4.1.2.   

Use-specific risk mitigation measures

— During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coverall (material to be specified by the authorisation holder within the product information) and eye/face protection.

— During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) (glove and coverall material to be specified by the authorisation holder within the product information).

— Keep out of reach of children.

— The general public and animals should be kept away from treated areas until surfaces are dry.

4.1.3.   

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

See general directions for use.

4.1.4.   

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

See general directions for use.

4.1.5.   

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

See general directions for use.

4.2.   

Use description

Table 11. Use # 2 – PT3 – Concentrated Surface disinfectant for veterinary use, Iodine

4.2.1.   

Use-specific instructions for use

Use in veterinary field (PT3), surface disinfection:

The product must be diluted with water before use (according to table below).

Clean the surfaces thoroughly with a detergent before disinfection. Rinse with clean water and remove surplus water.

The product is used to disinfect animal housings of pigs, cows and poultry.

Apply the product by spraying with a manual or an automatic sprayer. Make sure to wet the surface completely. Allow to take effect for at least 30 minutes. Animal housing must be empty of animals during application and re-entry of animals can be done 24h after the end of the application.

Do not mix with other chemicals.

Do not prepare more fluid than necessary.

4.2.2.   

Use-specific risk mitigation measures

— During pouring and pumping of the concentrated product: Wear chemical resistant gloves, coverall (material to be specified by the authorisation holder within the product information)and eye/face protection.

— During spraying of the product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) which is impermeable for the biocidal product (glove and coverall material to be specified by the authorisation holder within the product information).

— Only use one kind of Iodine-containing product per day.

— Due to potential concern for human health the same professional user shall not carry out animal house disinfection more than 3 times per month and shall not use Iodine products for other purposes during that period.

— Due to potential concern for animal health, disinfection of stables should not be carried out more than once per year or once per lifetime for calves and pigs. Feeding troughs must be covered during application.

— Keep out of reach of children.

— The general public and animals should be kept away from treated areas until surfaces are dry.

4.2.3.   

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

See general directions for use.

4.2.4.   

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

See general directions for use.

4.2.5.   

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

See general directions for use.

5.   

GENERAL DIRECTIONS FOR USE

 (8)

OF THE META SPC 8

5.1.   

Instructions for use

See use-specific instructions for use

5.2.   

Risk mitigation measures

See use-specific risk mitigation measures.

5.3.   

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

After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.

If medical advice is needed, have product container or label at hand.

After skin (or hair) contact: Remove contaminated clothing and shoes. Wash the affected area thoroughly with plenty of soap and water. Get medical attention if symptoms occur.

After ingestion: Rinse mouth. Spit. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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.

 

—  

—  

—  

 

5.5.   

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   

OTHER INFORMATION

7.   

THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 8

7.1.   

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

META SPC 9

1.   

META SPC 9 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 9 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 9 COMPOSITION

2.1.   

Qualitative and quantitative information on the composition of the meta SPC 9

2.2.   

Type(s) of formulation of the meta SPC 9

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9

4.   

AUTHORISED USE(S) OF THE META SPC 9

4.1.   

Use description

Table 12. Use # 1 – PT4 – Concentrated Cleaning in place disinfectant, Iodine

4.1.1.   

Use-specific instructions for use

See general instructions.

4.1.2.   

Use-specific risk mitigation measures

See general directions for use.

4.1.3.   

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

See general directions for use.

4.1.4.   

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

See general directions for use.

4.1.5.   

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

See general directions for use.

5.   

GENERAL DIRECTIONS FOR USE

 (9)

OF THE META SPC 9

5.1.   

Instructions for use

— Disinfection of milking machines or CIP installations in food industry

— Clean first the CIP installation.

— Apply the product in the automatic system with a dilution of the product (according to table below) with water.

— Use at room temperature.

— Respect a contact time according to the table below.

— Rinse the installation with water.

Do not mix with other chemicals.

5.2.   

Risk mitigation measures

During pouring and pumping of the concentrated product: Wear chemical resistant gloves and protective coverall (at least type X, EN XXXXX) (glove and coverall material to be specified by the authorisation holder within the product information) and eye/face protection.

Keep out of reach of children.

5.3.   

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

After inhalation: Remove person to fresh air and keep comfortable for breathing. Obtain medical attention if breathing difficulty persists.

After skin (or hair) contact: Remove contaminated clothing and shoes. Wash the affected area thoroughly with plenty of soap and water. Get medical attention if symptoms occur.

After eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Obtain emergency medical attention if pain, blinking, tears or redness persist.

After ingestion: Rinse mouth. Do NOT induce vomiting and immediately get medical advice.

Have product container or label at hand.

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.

 

—  

—  

—  

 

5.5.   

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

Keep only in the original container in a cool, well-ventilated place. Keep container closed when not in use.

Protect from frost. Do not expose to temperatures > 40 °C.

The shelf-life of the products is 2 years.

6.   

OTHER INFORMATION

7.   

THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 9

7.1.   

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

META SPC 10

1.   

META SPC 10 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 10 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 10 COMPOSITION

2.1.   

Qualitative and quantitative information on the composition of the meta SPC 10

2.2.