COMMISSION IMPLEMENTING REGULATION (EU) 2019/1794

of 22 October 2019

granting a Union authorisation for the biocidal product family ‘Boumatic Iodine product family’

(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 21 August 2015, Boumatic Gascoigne Melotte submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Boumatic Iodine product family’ of product-type 3, 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-PG019260-52 in the Register for Biocidal Products.

(2) The ‘Boumatic Iodine product family’ contains 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 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 products containing the active substance have to be reviewed in accordance with Article 48 of Regulation (EU) No 528/2012.

(3) On 10 April 2018, 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 4 April 2019, the Agency submitted to the Commission an opinion (3), including the draft summary of the biocidal product characteristics (‘SPC’) of the ‘Boumatic Iodine product family’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concludes that the ‘Boumatic Iodine product family’ 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.

(5) On 20 June 2019, 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.

(6) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the ‘Boumatic Iodine product family’.

(7) 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-0020541-0000 is granted to Boumatic Gascoigne Melotte for the making available on the market and use of the biocidal product family ‘Boumatic Iodine product family’, in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 18 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.

Done at Brussels, 22 October 2019.

For the Commission

The President

Jean-Claude JUNCKER

(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 27 February 2019 on the Union authorisation of ‘Boumatic Iodine product family’ (ECHA/BPC/220/2019).

ANNEX

Summary of product characteristics for a biocidal product family

Boumatic Iodine product family

Product type 3 — Veterinary hygiene (Disinfectants)

Authorisation number: EU-0020541-0000

R4BP asset number: EU-0020541-0000

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 – Manual dip treatment, pre- or post-milking teat disinfectants

4.1.1.   

Use-specific instructions for use

Product for disinfection of cow teat by dipping before or after milking.

Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip treatment.

Fill the dipping cup with indicated quantity of undiluted product straight from the original packaging. During every treatment, sufficient volume of treatment product needs to be present in the dipping cup. To reduce dermal exposure, the use of a dosing pump for filling the product into the application equipment is recommended.

4.1.2.   

Use-specific risk mitigation measures

Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder in the product information) and eye protection.

4.1.3.   

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

See general directions for use of the meta SPC 1

4.1.4.   

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

See general directions for use of the meta SPC 1

4.1.5.   

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

See general directions for use of the meta SPC 1

4.2.   

Use description

Table 2. Use # 2 – Manual spraying treatment pre- or post-milking teat disinfectants

4.2.1.   

Use-specific instructions for use

Product for disinfection of cow teat by spraying before or after milking.

Apply an amount of product that is sufficient to cover the entire teat at the maximum 15 ml per spray treatment.

Fill the spray flask with the indicated quantity of undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.

4.2.2.   

Use-specific risk mitigation measures

Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder in the product information), protective clothing, chemical resistant boots, and eye protection.

4.2.3.   

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

See general directions for use of the meta SPC 1

4.2.4.   

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

See general directions for use of the meta SPC 1

4.2.5.   

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

See general directions for use of the meta SPC 1

4.3.   

Use description

Table 3. Use # 3 – Automated dip treatment, pre- or post-milking teat disinfectants

4.3.1.   

Use-specific instructions for use

Product for disinfection of cow teat by dipping before or after milking.

Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip treatment.

Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.

4.3.2.   

Use-specific risk mitigation measures

See general directions for use of the meta SPC 1

4.3.3.   

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

See general directions for use of the meta SPC 1

4.3.4.   

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

See general directions for use of the meta SPC 1

4.3.5.   

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

See general directions for use of the meta SPC 1

4.4.   

Use description

Table 4. Use # 4 – Automated spraying treatment, pre- or post-milking teat disinfectants

4.4.1.   

Use-specific instructions for use

Product for disinfection of cow teat by spraying before or after milking.

Apply an amount of product that is sufficient to cover the entire teat, at the maximum of 15 ml per spray treatment.

Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.

4.4.2.   

Use-specific risk mitigation measures

See general directions for use of the meta SPC 1

4.4.3.   

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

See general directions for use of the meta SPC 1

4.4.4.   

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

See general directions for use of the meta SPC 1

4.4.5.   

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

See general directions for use of the meta SPC 1

5.   

GENERAL DIRECTIONS FOR USE

 (1)

OF THE META SPC 1

5.1.   

Instructions for use

The products must be brought to temperatures above 20 °C before use.

For pre-milking treatment: treat the entire teat with the product, let act 60 seconds and wipe teats dry using single-use towels to avoid any contamination of milk.

For post-milking treatment: The teats should be treated as soon as possible after milking in such a way that the teats are fully covered. Let the teats air dry. The cows should be kept in a standing position until the product is fully dried (at least 5 minutes).

5.2.   

Risk mitigation measures

In case a combination of pre- and post-milking disinfection is necessary, using another product not containing iodine has to be considered either for pre- or post-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

First aid: general information: immediately remove any clothing soiled by the product

After inhalation: Supply fresh air; consult doctor in case of complaints.

After skin contact: Wash skin thoroughly. Generally the product does not irritate the skin.

After eye contact: Rinse opened eye for several minutes under running water. Remove contact lenses, if present and easy to do. Continue rinsing.

After swallowing: Rinse out mouth and then drink water. If you feel unwell, get medical advice/attention.

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

Do not allow product to enter sewers surface or ground water.

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

Protect from frost. Store in a cool, dry place, away from direct sunlight and out of reach children.

Shelf life: 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 5. Use # 1 – Manual dip treatment, post milking teat disinfectants

4.1.1.   

Use-specific instructions for use

Product for disinfection of cow teat by dipping after milking.

Fill the dipping cup with the indicated quantity of undiluted product straight from the original packaging. During every treatment, sufficient volume of treatment product needs to be present in the dipping cup. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.

4.1.2.   

Use-specific risk mitigation measures

Wear eye protection.

4.1.3.   

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

See general directions for use of the meta SPC 2

4.1.4.   

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

See general directions for use of the meta SPC 2

4.1.5.   

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

See general directions for use of the meta SPC 2

4.2.   

Use description

Table 6. Use # 2 – Manual spraying treatment, post milking teat disinfectants

4.2.1.   

Use-specific instructions for use

Product for disinfection of cow teat by spraying after milking.

Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15 ml per spray treatment.

Fill the spray flask with the indicated quantity of undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.

4.2.2.   

Use-specific risk mitigation measures

Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder within the product information) and eye protection.

4.2.3.   

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

See general directions for use of the meta SPC 2

4.2.4.   

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

See general directions for use of the meta SPC 2

4.2.5.   

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

See general directions for use of the meta SPC 2

4.3.   

Use description

Table 7. Use # 3 – Automated dip treatment, post-milking teat disinfectants

4.3.1.   

Use-specific instructions for use

Product for disinfection of cow teat by dipping after milking.

Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip treatment.

Use the undiluted product straight from the original packaging. To reduce dermal exposure, the use of a dosing pump for filling the product into the application equipment is recommended.

4.3.2.   

Use-specific risk mitigation measures

See general directions for use of the meta SPC 2

4.3.3.   

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

See general directions for use of the meta SPC 2

4.3.4.   

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

See general directions for use of the meta SPC 2

4.3.5.   

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

See general directions for use of the meta SPC 2

4.4.   

Use description

Table 8. Use # 4 – Automated spraying treatment, post-milking teat disinfectants

4.4.1.   

Use-specific instructions for use

Product for disinfection of cow teat by spraying, after milking.

Apply an amount of product that is sufficient to cover the entire teat, at the maximum of 15 ml per spray treatment

Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.

4.4.2.   

Use-specific risk mitigation measures

See general directions for use of the meta SPC 2

4.4.3.   

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

See general directions for use of the meta SPC 2

4.4.4.   

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

See general directions for use of the meta SPC 2

4.4.5.   

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

See general directions for use of the meta SPC 2

5.   

GENERAL DIRECTIONS FOR USE

 (2)

OF THE META SPC 2

5.1.   

Instructions for use

The products must be brought to temperatures above 20 °C before use.

For post-milking treatment: The teats should be treated as soon as possible after milking in such a way that the teats are fully covered. Let the teats air dry. The cows should be kept in a standing position until the product is fully dried (at least 5 minutes).

5.2.   

Risk mitigation measures

In case 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

First aid: general information: immediately remove any clothing soiled by the product

After inhalation: Supply fresh air; consult doctor in case of complaints.

After skin contact: Wash skin thoroughly. Generally the product does not irritate the skin.

After eye contact: Rinse opened eye for several minutes under running water. Remove contact lenses, if present and easy to do. Continue rinsing.

After swallowing: Rinse out mouth and then drink water. If you feel unwell, get medical advice/attention.

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

Do not allow product to enter sewers surface or ground water.

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

Protect from frost. Store in a cool, dry place, away from direct sunlight and out of reach of children.

Shelf life: 1 year

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 9. Use # 1 – Manual dip treatment, post milking teat disinfectants

4.1.1.   

Use-specific instructions for use

Product for disinfection of cow teat by dipping after milking.

Fill the dipping cup with the indicated quantity of undiluted product straight from the original packaging. During every treatment, sufficient volume of treatment product needs to be present in the dipping cup To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.

4.1.2.   

Use-specific risk mitigation measures

Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder in the product information) and eye protection.

4.1.3.   

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

See general directions for use of the meta SPC 3

4.1.4.   

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

See general directions for use of the meta SPC 3

4.1.5.   

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

See general directions for use of the meta SPC 3

4.2.   

Use description

Table 10. Use # 2 – Manual spraying treatment, post milking teat disinfectants

4.2.1.   

Use-specific instructions for use

Product for disinfection of cow teat by spraying after milking.

Apply an amount of product that is sufficient to cover the entire teat, at the maximum 15 ml per spray treatment

Fill the spray flask with the indicated quantity of undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.

4.2.2.   

Use-specific risk mitigation measures

Wear protective chemical resistant gloves (glove material to be specified by the authorisation holder in the product information), protective clothing, chemical resistant boots, and eye protection.

4.2.3.   

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

See general directions for use of the meta SPC 3

4.2.4.   

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

See general directions for use of the meta SPC 3

4.2.5.   

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

See general directions for use of the meta SPC 3

4.3.   

Use description

Table 11. Use # 3 – Automated dip treatment, post-milking teat disinfectants

4.3.1.   

Use-specific instructions for use

Productfor disinfection of cow teat by dipping after milking.

Apply an amount of product that is sufficient to cover the entire teat, at the maximum 10 ml per dip treatment.

Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.

4.3.2.   

Use-specific risk mitigation measures

See general directions for use of the meta SPC 3

4.3.3.   

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

See general directions for use of the meta SPC 3

4.3.4.   

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

See general directions for use of the meta SPC 3

4.3.5.   

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

See general directions for use of the meta SPC 3

4.4.   

Use description

Table 12. Use # 4 – Automated spraying treatment, post-milking teat disinfectants

4.4.1.   

Use-specific instructions for use

Product for disinfection of cow teat by spraying after milking.

Apply an amount of product that is sufficient to cover the entire teat, at the maximum of 15 ml per spray treatment.

Use the undiluted product straight from the original packaging. To reduce dermal exposure, use of a dosing pump for filling the product into the application equipment is recommended.

4.4.2.   

Use-specific risk mitigation measures

See general directions for use of the meta SPC 3

4.4.3.   

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

See general directions for use of the meta SPC 3

4.4.4.   

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

See general directions for use of the meta SPC 3

4.4.5.   

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

See general directions for use of the meta SPC 3

5.   

GENERAL DIRECTIONS FOR USE

 (3)

OF THE META SPC 3

5.1.   

Instructions for use

The products must be brought to temperatures above 20 °C before use.

For post-milking treatment: The teats should be treated as soon as possible after milking in such a way that the teats are fully covered. Let the teats air dry. The cows should be kept in a standing position until the product is fully dried (at least 5 minutes).

5.2.   

Risk mitigation measures

In case 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

First aid: general information: immediately remove any clothing soiled by the product

After inhalation: Supply fresh air; consult doctor in case of complaints.

After skin contact: Wash skin thoroughly. Generally the product does not irritate the skin.

After eye contact: Rinse opened eye for several minutes under running water. Remove contact lenses, if present and easy to do. Continue rinsing.

After swallowing: Rinse out mouth and then drink water. If you feel unwell, get medical advice/attention.

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

Do not allow product to enter sewers surface or ground water.

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

Protect from frost. Store in a cool, dry place, away from direct sunlight and out of reach of children.

Shelf life: 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

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

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

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