COMMISSION IMPLEMENTING REGULATION (EU) 2019/403

of 13 March 2019

granting a Union authorisation for the biocidal product family ‘Deosan Activate BPF based on Iodine’

THE EUROPEAN COMMISSION,

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

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

Whereas:

(1) On 7 July 2015, Diversey Europe Operations B.V. submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Deosan Activate BPF based on Iodine’ (‘the product family’) of product-type 3, as described in Annex V to that Regulation. The competent authority of United Kingdom agreed to evaluate the application as referred to in Article 43(1) of Regulation (EU) No 528/2012. The application was recorded under the case number BC-JN018376-30 in the Register for Biocidal Products.

(2) The biocidal 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 20 December 2017, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

(4) On 6 July 2018, the Agency submitted to the Commission an opinion (3), including the draft summary of the biocidal product characteristics (‘SPC’) of the product family and the final assessment report on the product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. The opinion concludes that the product family falls within the definition of ‘biocidal product family’ laid down in 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, the product family meets the conditions laid down in Article 19(1) and (6) of that Regulation.

(5) On 17 September 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.

(6) The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal 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 is granted to Diversey Europe Operations B.V. for the biocidal product family ‘Deosan Activate BPF based on Iodine’ with authorisation number EU-0019228-0000.

The Union authorisation is valid from 3 April 2019 until 31 March 2029.

The Union authorisation is subject to compliance with the summary of the biocidal product characteristics set out in the Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the

Official Journal of the European Union

.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 13 March 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 6 July 2018 on the Union authorisation of ‘Deosan Activate BPF based on Iodine’ (ECHA/BPC/207/2018).

ANNEX

Summary of product characteristics for a biocidal product family

Deosan Activate BPF based on Iodine

Product type 3 — Veterinary hygiene (Disinfectants)

Authorisation number: EU-0019228-0000

R4BP asset number: EU-0019228-0000

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 – Pre-milking disinfection, manual dipping (concentrate)

4.1.1.   

Use-specific instructions for use

For products containing 1,5 % iodine this can be: Dilute 1 part of product to 4 parts water to achieve 0,3 % in use iodine concentration. For products with another concentration this instruction should be adapted.

Apply directly to animal teats pre-milking via manual dipping method.

3 pre-milking applications, per animal, per day

Apply a maximum of 10 ml product/animal/application

4.1.2.   

Use-specific risk mitigation measures

See section 5 — 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 section 5 — General Directions for Use

4.1.4.   

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

See section 5 — 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 section 5 — General Directions for Use

4.2.   

Use description

Table 2. Use # 2 – Pre-milking disinfection, manual foaming (concentrate)

4.2.1.   

Use-specific instructions for use

For products containing 1,5 % iodine: Dilute 1 part of product to 4 parts water to achieve 0,3 % in use iodine concentration. For products with another concentration this instruction should be adapted.

Apply directly to animal teats pre-milking via manual foaming application method.

3 pre-milking applications, per animal, per day

Apply a maximum of 5 ml product/animal/application

4.2.2.   

Use-specific risk mitigation measures

See section 5 — General Directions for Use

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 section 5 — General Directions for Use

4.2.4.   

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

See section 5 — 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 section 5 — General Directions for Use

4.3.   

Use description

Table 3. Use # 3 – Pre-milking disinfection, manual spraying (concentrate)

4.3.1.   

Use-specific instructions for use

For products containing 1,5 % iodine: Dilute 1 part of product to 4 parts water to achieve 0,3 % in use iodine concentration. For products with another concentration this instruction should be adapted.

Apply directly to animal teats pre-milking via manual spraying application method.

3 pre-milking applications, per animal, per day

Apply a maximum of 15 ml product/animal/application

4.3.2.   

Use-specific risk mitigation measures

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information)

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 section 5 — General Directions for Use

4.3.4.   

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

See section 5 — General Directions for Use

4.3.5.   

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

See section 5 — General Directions for Use

4.4.   

Use description

Table 4. Use # 4 – Post-milking disinfection, manual dipping (concentrate)

4.4.1.   

Use-specific instructions for use

Applied directly to animal teats post milking via manual dipping method.

For products containing 1,5 % iodine: Dilute 1 part of product to 4 parts water to achieve 0,3 % in use iodine concentration. For products with another concentration this instruction should be adapted.

3 post milking applications, per animal, per day (5 applications in total)

Apply a maximum of 10 ml product/animal/application

4.4.2.   

Use-specific risk mitigation measures

See section 5 — General Directions for Use

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 section 5 — General Directions for Use

4.4.4.   

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

See section 5 — General Directions for Use

4.4.5.   

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

See section 5 — General Directions for Use

4.5.   

Use description

Table 5. Use # 5 – Post-milking disinfection, manual foaming (concentrate)

4.5.1.   

Use-specific instructions for use

Applied directly to animal teats post milking via manual foaming method.

For products containing 1,5 % iodine: Dilute 1 part of product to 4 parts water to achieve 0,3 % in use iodine concentration. For products with another concentration this instruction should be adapted.

3 post milking applications, per animal, per day

Apply a maximum of 5 ml product/animal/application

4.5.2.   

Use-specific risk mitigation measures

See section 5 — General Directions for Use

4.5.3.   

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

See section 5 — General Directions for Use

4.5.4.   

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

See section 5 — General Directions for Use

4.5.5.   

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

See section 5 — General Directions for Use

4.6.   

Use description

Table 6. Use # 6 – Post-milking disinfection, manual spraying (concentrate)

4.6.1.   

Use-specific instructions for use

Applied directly to animal teats post milking via manual spraying method.

For products containing 1,5 % iodine: Dilute 1 part of product to 4 parts water to achieve 0,3 % in use iodine concentration. For products with another concentration this instruction should be adapted.

3 post milking applications, per animal, per day

Apply a maximum of 15 ml product/animal/application

4.6.2.   

Use-specific risk mitigation measures

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information)

4.6.3.   

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

See section 5 — General Directions for Use

4.6.4.   

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

See section 5 — General Directions for Use

4.6.5.   

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

See section 5 — General Directions for Use

4.7.   

Use description

Table 7. Use # 7 – Post-milking disinfection, automatic spraying (concentrate)

4.7.1.   

Use-specific instructions for use

Applied directly to animal teats post milking via automatic spraying method.

For products containing 1,5 % iodine: Dilute 1 part of product to 4 parts water to achieve 0,3 % in use iodine concentration. For products with another concentration this instruction should be adapted.

5 post milking applications, per animal, per day. Not to be combined with Iodine based pre-milking disinfection.

Apply a maximum of 15 ml product/animal/application

4.7.2.   

Use-specific risk mitigation measures

See section 5 — General Directions for Use

4.7.3.   

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

See section 5 — General Directions for Use

4.7.4.   

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

See section 5 — General Directions for Use

4.7.5.   

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

See section 5 — General Directions for Use

4.8.   

Use description

Table 8. Use # 8 – Post-milking disinfection, semi-automatic dipping (concentrate)

4.8.1.   

Use-specific instructions for use

Applied directly to animal teats post milking via semi-automatic dipping method.

For products containing 1,5 % iodine: Dilute 1 part of product to 4 parts water to achieve 0,3 % in use iodine concentration. For products with another concentration this instruction should be adapted.

3 post milking applications, per animal, per day

Apply a maximum of 10 ml product/animal/application

4.8.2.   

Use-specific risk mitigation measures

See section 5 — General Directions for Use

4.8.3.   

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

See section 5 — General Directions for Use

4.8.4.   

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

See section 5 — General Directions for Use

4.8.5.   

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

See section 5 — General Directions for Use

4.9.   

Use description

Table 9. Use # 9 – Pre and post-milking disinfection, manual dipping (concentrate)

4.9.1.   

Use-specific instructions for use

For products containing 1,5 % iodine: Dilute 1 part of product to 4 parts water to achieve 0,3 % in use iodine concentration. For products with another concentration this instruction should be adapted.

Apply directly to animal teats pre and post milking via manual dipping method.

3 pre and 3 post milking applications, per animal, per day (up to 5 applications in total)

Apply a maximum of 10 ml product/animal/application

4.9.2.   

Use-specific risk mitigation measures

See section 5 — General Directions for Use

4.9.3.   

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

See section 5 — General Directions for Use

4.9.4.   

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

See section 5 — General Directions for Use

4.9.5.   

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

See section 5 — General Directions for Use

4.10.   

Use description

Table 10. Use # 10 – Pre and post-milking disinfection, manual foaming (concentrate)

4.10.1.   

Use-specific instructions for use

For products containing 1,5 % iodine: Dilute 1 part of product to 4 parts water to achieve 0,3 % in use iodine concentration. For products with another concentration this instruction should be adapted.

Apply directly to animal teats pre and post milking via manual foaming application method.

3 pre and 3 post milking applications, per animal, per day (up to 5 applications in total)

Apply a maximum of 5 ml product/animal/application

4.10.2.   

Use-specific risk mitigation measures

See section 5 — General Directions for Use

4.10.3.   

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

See section 5 — General Directions for Use

4.10.4.   

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

See section 5 — General Directions for Use

4.10.5.   

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

See section 5 — General Directions for Use

4.11.   

Use description

Table 11. Use # 11 – Pre and post-milking disinfection, manual spraying (concentrate)

4.11.1.   

Use-specific instructions for use

For products containing 1,5 % iodine: Dilute 1 part of product to 4 parts water to achieve 0,3 % in use iodine concentration. For products with another concentration this instruction should be adapted.

Apply directly to animal teats pre and post milking via manual spraying application method.

3 pre and 3 post milking applications, per animal, per day (up to 5 applications in total)

Apply a maximum of 15 ml product/animal/application

4.11.2.   

Use-specific risk mitigation measures

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information)

Wear suitable protective footwear (EN 13832) when applying the product.

A protective coverall (at least type 6, EN 13034) shall be worn

4.11.3.   

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

See section 5 — General Directions for Use

4.11.4.   

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

See section 5 — General Directions for Use

4.11.5.   

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

See section 5 — General Directions for Use

5.   GENERAL DIRECTIONS FOR USE (1) OF THE META SPC 1

5.1.   

Instructions for use

The product must be brought to temperature > 20 °C before use

 

Pre milking:

 

Apply product to full length of each teat.

 

For effective use against bacteria and yeast, product must be left in contact with the skin for at least 30 seconds.

 

After the appropriate contact time, thoroughly remove the product, using a single service paper towel/cloth to ensure teats are clean and dry.

 

In use iodine concentration of 3 000 mg/Kg (0,3 % w/w)

 

Post milking:

 

Cover the full length of each teat with the product, immediately after milking.

 

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

 

In use iodine concentration of 3 000 mg/Kg (0,3 % w/w)

5.2.   

Risk mitigation measures

This product can be used for pre- and post-milking disinfection in combination (up to 5 applications in total per animal per day). However, it should not be used in combination with a different iodine-based product.

The use of a dosing pump for filling the product into the application equipment is recommended.

5.3.   

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

Inhalation: No known effects or symptoms in normal use.

Skin contact: No known effects or symptoms in normal use.

Eye contact: No known effects or symptoms in normal use.

Ingestion: No known effects or symptoms in normal use

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

After skin contact: Instantly wash with water and soap and rinse thoroughly.

After eye contact: Rinse opened eye for several minutes under running water (at least 15 minutes).

After swallowing: Rinse out mouth and then drink plenty of water. Instantly call for doctor.

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

Stability and reactivity:

 

Reactivity: No reactivity hazards known under normal storage and use conditions.

 

Chemical stability: Stable under normal storage and use conditions.

 

Possibility of hazardous reactions: No hazardous reactions known under normal storage and use conditions.

 

Conditions to avoid: None known under normal storage and use conditions.

 

Hazardous decomposition products: None known under normal storage and use conditions.

Environmental precautions:

 

Dike to collect larger liquid spills.

 

Contain and/or absorb spill with inert material, then place in suitable container.

 

Prevent run-off from entering drains, sewers or waterways.

 

Collect in closed and suitable containers for disposal.

 

Do not place spilled materials back into the original container.

5.4.   

Instructions for safe disposal of the product and its packaging

Empty containers must be tripled rinsed prior to disposal

Paper towels used to dry animal teats and remove the product from them should be disposed of as normal/domestic waste.

Do not discharge undiluted product to sewers.

5.5.   

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

Store only in original, closed container

Protect from frost

Do not store at temperatures above 40 °C

Shelf life 24 months

6.   OTHER INFORMATION

None

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

7.2.   

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 12. Use # 1 – Pre-milking disinfection, manual dipping (RTU liquid)

4.1.1.   

Use-specific instructions for use

Applied directly to animal teats pre-milking via manual dipping methods.

Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.

3 pre-milking applications, per animal, per day.

Apply a maximum of 10 ml product/animal/application

4.1.2.   

Use-specific risk mitigation measures

See section 5 — 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 section 5 — General Directions for Use

4.1.4.   

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

See section 5 — 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 section 5 — General Directions for Use

4.2.   

Use description

Table 13. Use # 2 – Pre-milking disinfection, manual foaming (RTU liquid)

4.2.1.   

Use-specific instructions for use

Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.

Apply directly to animal teats pre-milking via manual foaming application method.

3 pre-milking applications, per animal, per day.

Apply a maximum of 5 ml product/animal/application

4.2.2.   

Use-specific risk mitigation measures

See section 5 — General Directions for Use

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 section 5 — General Directions for Use

4.2.4.   

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

See section 5 — 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 section 5 — General Directions for Use

4.3.   

Use description

Table 14. Use # 3 – Pre-milking disinfection, manual spraying (RTU liquid)

4.3.1.   

Use-specific instructions for use

Applied directly to animal teats pre-milking via manual spraying method.

Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.

3 pre-milking applications, per animal, per day.

Apply a maximum of 15 ml product/animal/application

4.3.2.   

Use-specific risk mitigation measures

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information)

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 section 5 — General Directions for Use

4.3.4.   

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

See section 5 — General Directions for Use

4.3.5.   

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

See section 5 — General Directions for Use

4.4.   

Use description

Table 15. Use # 4 – Post-milking disinfection, manual dipping (RTU liquid)

4.4.1.   

Use-specific instructions for use

Applied directly to animal teats post milking via manual dipping method.

Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.

3 post milking applications, per animal, per day.

Apply a maximum of 10 ml product/animal/application

4.4.2.   

Use-specific risk mitigation measures

See section 5 — General Directions for Use

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 section 5 — General Directions for Use

4.4.4.   

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

See section 5 — General Directions for Use

4.4.5.   

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

See section 5 — General Directions for Use

4.5.   

Use description

Table 16. Use # 5 – Post-milking disinfection, manual foaming (RTU liquid)

4.5.1.   

Use-specific instructions for use

Applied directly to animal teats post milking via manual foaming method.)

Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.

3 post milking applications, per animal, per day.

Apply a maximum of 5 ml product/animal/application

4.5.2.   

Use-specific risk mitigation measures

See section 5 — General Directions for Use

4.5.3.   

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

See section 5 — General Directions for Use

4.5.4.   

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

See section 5 — General Directions for Use

4.5.5.   

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

See section 5 — General Directions for Use

4.6.   

Use description

Table 17. Use # 6 – Post-milking disinfection, manual spraying (RTU liquid)

4.6.1.   

Use-specific instructions for use

Applied directly to animal teats post milking via manual spraying method.

Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.

3 post milking applications, per animal, per day.

Apply a maximum of 15 ml product/animal/application

4.6.2.   

Use-specific risk mitigation measures

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information)

4.6.3.   

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

See section 5 — General Directions for Use

4.6.4.   

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

See section 5 — General Directions for Use

4.6.5.   

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

See section 5 — General Directions for Use

4.7.   

Use description

Table 18. Use # 7 – Post-milking disinfection, automatic spraying (not to be combined with a pre-milking disinfection (RTU liquid)

4.7.1.   

Use-specific instructions for use

Applied directly to animal teats post milking via automatic spraying method.

Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.

5 post milking applications, per animal, per day. Not to be combined with iodine based pre-milking disinfection.

Apply a maximum of 15 ml product/animal/application

4.7.2.   

Use-specific risk mitigation measures

See section 5 — General Directions for Use

4.7.3.   

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

See section 5 — General Directions for Use

4.7.4.   

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

See section 5 — General Directions for Use

4.7.5.   

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

See section 5 — General Directions for Use

4.8.   

Use description

Table 19. Use # 8 – Post-milking disinfection, semi-automatic dipping (RTU liquid)

4.8.1.   

Use-specific instructions for use

Applied directly to animal teats post milking via semi-automatic dipping method.

Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.

3 post milking applications, per animal, per day.

Apply a maximum of 10 ml product/animal/application

4.8.2.   

Use-specific risk mitigation measures

See section 5 — General Directions for Use

4.8.3.   

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

See section 5 — General Directions for Use

4.8.4.   

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

See section 5 — General Directions for Use

4.8.5.   

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

See section 5 — General Directions for Use

4.9.   

Use description

Table 20. Use # 9 – Pre and post milking disinfection, manual dipping (RTU liquid)

4.9.1.   

Use-specific instructions for use

Applied directly to animal teats pre-milking via manual dipping methods.

Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.

3 pre and 3 post milking applications, per animal, per day (up to 5 applications in total).

Apply a maximum of 10 ml product/animal/application

4.9.2.   

Use-specific risk mitigation measures

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information)

4.9.3.   

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

See section 5 — General Directions for Use

4.9.4.   

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

See section 5 — General Directions for Use

4.9.5.   

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

See section 5 — General Directions for Use

4.10.   

Use description

Table 21. Use # 10 – Pre and post milking disinfection, manual foaming (RTU liquid)

4.10.1.   

Use-specific instructions for use

Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.

Apply directly to animal teats pre and post milking via manual foaming application method.

3 pre and 3 post milking applications, per animal, per day (up to 5 applications in total).

Apply a maximum of 5 ml product/animal/application

4.10.2.   

Use-specific risk mitigation measures

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information)

4.10.3.   

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

See section 5 — General Directions for Use

4.10.4.   

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

See section 5 — General Directions for Use

4.10.5.   

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

See section 5 — General Directions for Use

4.11.   

Use description

Table 22. Use # 11 – Pre and post milking disinfection, manual spraying (RTU liquid)

4.11.1.   

Use-specific instructions for use

Applied directly to animal teats pre and post milking via manual spraying method.

Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.

3 pre and 3 post milking applications, per animal, per day (up to 5 applications in total).

Apply a maximum of 15 ml product/animal/application

4.11.2.   

Use-specific risk mitigation measures

Wear protective chemical resistant gloves during product handling phase (glove material to be specified by the authorisation holder within the product information

Wear suitable protective footwear (EN 13832) when applying the product.

A protective coverall (at least type 6, EN 13034) shall be worn

4.11.3.   

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

See section 5 — General Directions for Use

4.11.4.   

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

See section 5 — General Directions for Use

4.11.5.   

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

See section 5 — 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 temperature > 20 °C before use

 

Pre milking:

 

Apply product to full length of each teat.

 

For effective use against bacteria and yeast, product must be left in contact with the skin for at least 30 seconds.

 

After the appropriate contact time, thoroughly remove the product, using a single service paper towel/cloth to ensure teats are clean and dry.

 

In use iodine concentration of 3 000 mg/Kg (0,3 % w/w)

 

Post milking:

 

Cover the full length of each teat with the product, immediately after milking.

 

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

 

In use iodine concentration of 3 000 mg/Kg (0,3 % w/w)

5.2.   

Risk mitigation measures

This product can be used for pre- and post-milking disinfection in combination (up to 5 applications in total per animal per day). However, it should not be used in combination with a different iodine-based product

The use of a dosing pump for filling the product into the application equipment is recommended.

5.3.   

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

Inhalation: No known effects or symptoms in normal use.

Skin contact: No known effects or symptoms in normal use.

Eye contact: No known effects or symptoms in normal use.

Ingestion: No known effects or symptoms in normal use

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

After skin contact: Instantly wash with water and soap and rinse thoroughly.

After eye contact: Rinse opened eye for several minutes under running water (at least 15 minutes).

After swallowing: Rinse out mouth and then drink plenty of water. Instantly call for doctor.

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

Stability and reactivity:

 

Reactivity: No reactivity hazards known under normal storage and use conditions.

 

Chemical stability: Stable under normal storage and use conditions.

 

Possibility of hazardous reactions: No hazardous reactions known under normal storage and use conditions.

 

Conditions to avoid: None known under normal storage and use conditions.

 

Hazardous decomposition products: None known under normal storage and use conditions.

Environmental precautions:

 

Dike to collect larger liquid spills.

 

Contain and/or absorb spill with inert material, then place in suitable container.

 

Prevent run-off from entering drains, sewers or waterways.

 

Collect in closed and suitable containers for disposal.

 

Do not place spilled materials back into the original container.

5.4.   

Instructions for safe disposal of the product and its packaging

Empty containers must be tripled rinsed prior to disposal

Paper towels used to dry animal teats and remove the product from them should be disposed of as normal/domestic waste.

Do not discharge undiluted product to sewers.

5.5.   

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

Store only in original, closed container

Protect from frost

Do not store at temperatures above 30 °C

Shelf life 24 months

6.   OTHER INFORMATION

None

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

7.3.   

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 23. Use # 1 – Pre-milking disinfection, manual dipping (RTU gel)

4.1.1.   

Use-specific instructions for use

Applied directly to animal teats pre- milking via manual dipping application method.

Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.

3 pre milking applications, per animal, per day.

Apply a maximum of 10 ml product/animal/application

4.1.2.   

Use-specific risk mitigation measures

See section 5 — 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 section 5 — General Directions for Use

4.1.4.   

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

See section 5 — 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 section 5 — General Directions for Use

4.2.   

Use description

Table 24. Use # 2 – Post-milking disinfection, manual dipping (RTU gel)

4.2.1.   

Use-specific instructions for use

Applied directly to animal teats post milking via manual dipping method.

Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.

2-3 post milking applications, per animal, per day.

Apply a maximum of 10 ml product/animal/application

4.2.2.   

Use-specific risk mitigation measures

See section 5 — General Directions for Use

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 section 5 — General Directions for Use

4.2.4.   

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

See section 5 — 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 section 5 — General Directions for Use

4.3.   

Use description

Table 25. Use # 3 – Post-milking disinfection, semi-automatic dipping (RTU gel)

4.3.1.   

Use-specific instructions for use

Applied directly to animal teats post milking via semi-automatic dipping method.

Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.

3 post milking applications, per animal, per day.

Apply a maximum of 10 ml product/animal/application

4.3.2.   

Use-specific risk mitigation measures

See section 5 — General Directions for Use

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 section 5 — General Directions for Use

4.3.4.   

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

See section 5 — General Directions for Use

4.3.5.   

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

See section 5 — General Directions for Use

4.4.   

Use description

Table 26. Use # 4 – Pre and post-milking disinfection, manual dipping (RTU gel)

4.4.1.   

Use-specific instructions for use

Applied directly to animal teats pre and post milking via manual dipping application method.

Ready to use formulation containing 0,3 % w/w iodine. Do not dilute before use.

3 pre and 3 post milking applications, per animal, per day (up to 5 applications in total)

Apply a maximum of 10 ml product/animal/application

4.4.2.   

Use-specific risk mitigation measures

Wear protective chemical resistant gloves when applying the product by dipping (glove material to be specified by the authorisation holder within the product information)

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 section 5 — General Directions for Use

4.4.4.   

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

See section 5 — General Directions for Use.

4.4.5.   

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

See section 5 — General Directions for Use

5.   GENERAL DIRECTIONS FOR USE (3) OF THE META SPC 3

5.1.   

Instructions for use

The product must be brought to temperature > 20 °C before use

 

Pre milking:

 

Apply product to full length of each teat.

 

For effective use against bacteria and yeast, product must be left in contact with the skin for at least 30 seconds.

 

After the appropriate contact time, thoroughly remove the product, using a single service paper towel/cloth to ensure teats are clean and dry.

 

In use iodine concentration of 3 000 mg/Kg (0,3 % w/w)

 

Post milking:

 

Cover the full length of each teat with the product, immediately after milking.

 

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

 

In use iodine concentration of 3 000 mg/Kg (0,3 % w/w)

5.2.   

Risk mitigation measures

This product can be used for pre- and post-milking disinfection in combination (up to 5 applications in total per animal per day). However, it should not be used in combination with a different iodine-based product

The use of a dosing pump for filling the product into the application equipment is recommended.

5.3.   

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

Inhalation: No known effects or symptoms in normal use.

Skin contact: No known effects or symptoms in normal use.

Eye contact: No known effects or symptoms in normal use.

Ingestion: No known effects or symptoms in normal use

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

After skin contact: Instantly wash with water and soap and rinse thoroughly.

After eye contact: Rinse opened eye for several minutes under running water (at least 15 minutes).

After swallowing: Rinse out mouth and then drink plenty of water. Instantly call for doctor.

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

Stability and reactivity:

 

Reactivity: No reactivity hazards known under normal storage and use conditions.

 

Chemical stability: Stable under normal storage and use conditions.

 

Possibility of hazardous reactions: No hazardous reactions known under normal storage and use conditions.

 

Conditions to avoid: None known under normal storage and use conditions.

 

Hazardous decomposition products: None known under normal storage and use conditions.

Environmental precautions:

 

Dike to collect larger liquid spills.

 

Contain and/or absorb spill with inert material, then place in suitable container.

 

Prevent run-off from entering drains, sewers or waterways.

 

Collect in closed and suitable containers for disposal.

 

Do not place spilled materials back into the original container.

5.4.   

Instructions for safe disposal of the product and its packaging

Empty containers must be tripled rinsed prior to disposal

Paper towels used to dry animal teats and remove the product from them should be disposed of as normal/domestic waste.

Do not discharge undiluted product to sewers.

5.5.   

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

Store only in original, closed container

Protect from frost

Do not store at temperatures above 30 °C

Shelf life 18 months

6.   OTHER INFORMATION

None

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.