COMMISSION IMPLEMENTING REGULATION (EU) 2023/1311

of 27 June 2023

granting a Union authorisation for the biocidal product family ‘CVAS Biocidal Product Family based on L (+) Lactic Acid’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

(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 Article 44(5), first subparagraph, thereof,

Whereas:

(1) On 24 April 2019, CVAS Development GmbH submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for a Union authorisation of a biocidal product family named ‘CVAS Biocidal Product Family based on L (+) Lactic Acid’ of product-types 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Slovenia had agreed to evaluate the application. The application was recorded under case number BC-XR051157-11 in the Register for Biocidal Products.

(2) ‘CVAS Biocidal Product Family based on L (+) Lactic Acid’ contains L-(+)-lactic acid as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 3 and 4.

(3) On 7 January 2022, 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 Agency.

(4) On 5 July 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘CVAS Biocidal Product Family based on L (+) Lactic Acid’ 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 ‘CVAS Biocidal Product Family based on L (+) Lactic Acid’ is a biocidal product family within the meaning of Article 3(1), point (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 20 July 2022, 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 ‘CVAS Biocidal Product Family based on L (+) Lactic Acid’.

(8) 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-0028957-0000 is hereby granted to CVAS Development GmbH for the making available on the market and use of the biocidal product family ‘CVAS Biocidal Product Family based on L (+) Lactic Acid’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 18 July 2023 to 30 June 2033.

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, 27 June 2023.

For the Commission

The President

Ursula VON DER LEYEN

(1)  

OJ L 167, 27.6.2012, p. 1

.

(2)  ECHA opinion of 15 June 2022 on the Union authorisation of ‘CVAS Biocidal Product Family based on L (+) Lactic Acid’ (ECHA/BPC/345/2022), https://echa.europa.eu/opinions-on-union-authorisation

ANNEX

Summary of product characteristics for a biocidal product family

CVAS Biocidal Product Family based on L(+) Lactic Acid

Product type 3 - Veterinary hygiene (Disinfectants)

Product type 4 - Food and feed area (Disinfectants)

Authorisation number: EU-0028957-0000

R4BP asset number: EU-0028957-0000

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 – Use # 1.1 - Teat-disinfection post-milking by manual or automated dipping

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 brought to a temperature between 20°C and 30°C before use.

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

Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.

Apply the product by manual or automated dipping. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection clean the application equipment by rinsing with water.

5.2.   

Risk mitigation measures

None

5.3.   

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

First aid instructions

IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.

IF ON SKIN: wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.

IF IN EYES: if symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.

IF SWALLOWED: if symptoms occur call a POISON CENTRE or a doctor.

Emergency measure to protect the environment

Environmental precautions: do not allow product to reach sewage systems or water bodies.

Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like

sawdust. Dispose of the material collected in accordance with local regulations.

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 municipal sewer or disposed to the manure deposit depending on local requirements.

5.5.   

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

Shelf life: 24 months

Do not store at temperatures above 40°C.

Keep away from heat and direct sunlight.

Protect from frost.

Keep container tightly closed.

6.   

OTHER INFORMATION

Not relevant

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

7.3.   

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

7.4.   

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 – Use # 2.1 - Teat-disinfection post-milking by manual or automated dipping

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 between 20°C and 30°C before use.

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

Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.

Apply the product by manual or automated dipping. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection clean the application equipment by rinsing with water.

Keep out of reach of children.

5.2.   

Risk mitigation measures

Wear chemical goggles consistent with the European Standard EN ISO 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN ISO 374 or equivalent. See section 6 for the full titles of the EN standards.

Goggles, gloves and coverall material to be specified by the authorisation holder within the product information.

This is without prejudice to the application of Council Directive 98/24/EC and other Union legislation in the area of health and safety at work. See section 6 for the full reference to this act.

5.3.   

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

First aid instructions

IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.

IF ON SKIN: take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF IN EYES: immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112 or an ambulance for medical assistance.

IF SWALLOWED: immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

Emergency measure to protect the environment

Environmental precautions: do not allow product to reach sewage systems or water bodies.

Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like sawdust. Dispose of the material collected in accordance with local regulations.

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 municipal sewer or disposed to the manure deposit depending on local requirements.

5.5.   

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

Shelf life: 24 months

Do not store at temperatures above 40°C.

Keep away from heat and direct sunlight.

Protect from frost.

Keep container tightly closed.

6.   

OTHER INFORMATION

The full titles of EN standards mentioned in the section 5.2 ‘Risk mitigation measures’ are:

 

EN ISO 16321– Eye and face protection for occupational users.

 

EN ISO 374 – Protective gloves against dangerous chemicals and micro-organisms.

The full reference of the legal act mentioned in the section 5.2 ‘Risk mitigation measures’ is:

 

Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (

OJ L 131, 5.5.1998, p. 11

).

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

7.4.   

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 – Use # 3.1 – Teat-disinfection post-milking by manual or automated dipping or spraying

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

The product must be brought to a temperature between 20°C and 30°C before use.

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

Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.

Apply the product by manual or automated dipping or spraying. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection clean the application equipment by rinsing with water.

5.2.   

Risk mitigation measures

None

5.3.   

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

First aid instructions

IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.

IF ON SKIN: wash skin with water. If symptoms occur call a POISON CENTRE or a doctor.

IF IN EYES: if symptoms occur rinse with water. Remove contact lenses, if present and easy to do. Call a POISON CENTRE or a doctor.

IF SWALLOWED: if symptoms occur call a POISON CENTRE or a doctor.

Emergency measure to protect the environment

Environmental precautions: do not allow product to reach sewage systems or water bodies.

Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like sawdust. Dispose of the material collected in accordance with local regulations.

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 municipal sewer or disposed to the manure deposit depending on local requirements.

5.5.   

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

Shelf life: 24 months

Do not store at temperatures above 40°C.

Keep away from heat and direct sunlight.

Protect from frost.

Keep container tightly closed.

6.   

OTHER INFORMATION

Not relevant

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

7.3.   

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

7.4.   

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 – Use # 4.1 - Teat-disinfection post-milking by manual or automated dipping or spraying

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

 (4)

OF THE META SPC 4

5.1.   

Instructions for use

The product must be brought to a temperature between 20°C and 30°C before use.

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

Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.

Apply the product by manual or automated dipping or spraying. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection clean the application equipment by rinsing with water.

Keep out of reach of children.

5.2.   

Risk mitigation measures

Wear chemical goggles consistent with the European Standard EN ISO 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN ISO 374 or equivalent.

Goggles, gloves and coverall material to be specified by the authorisation holder within the product information.

This is without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.

5.3.   

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

First aid instructions

IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.

IF ON SKIN: take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF IN EYES: immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112 or an ambulance for medical assistance.

IF SWALLOWED: immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

Emergency measure to protect the environment

Environmental precautions: do not allow product to reach sewage systems or water bodies.

Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like

sawdust. Dispose of the material collected in accordance with local regulations.

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 municipal sewer or disposed to the manure deposit depending on local requirements.

5.5.   

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

Shelf life: 24 months

Do not store at temperatures above 40°C.

Keep away from heat and direct sunlight.

Protect from frost.

Keep container tightly closed.

6.   

OTHER INFORMATION

Not relevant

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

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

7.4.   

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 5

Use # 1 – Use # 5.1 – Teat-disinfection post-milking by manual or automated dipping or spraying

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 between 20°C and 30°C before use.

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

Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.

Apply the product by manual or automated dipping or spraying. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection clean the application equipment by rinsing with water.

Keep out of reach of children.

5.2.   

Risk mitigation measures

Wear chemical goggles consistent with the European Standard EN ISO 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN ISO 374 or equivalent.

Goggles, gloves and coverall material to be specified by the authorisation holder within the product information.

This is without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.

5.3.   

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

First aid instructions

IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.

IF ON SKIN: take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF IN EYES: rinse with water. Remove contact lenses, if present and easy to do. Continue rinsing for 5 minutes. Call a POISON CENTRE or a doctor.

IF SWALLOWED: rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call a POISON CENTRE or a doctor.

Emergency measure to protect the environment

Environmental precautions: no special environmental measures are necessary. Clean contaminated articles and floor in accordance with the environmental legislation.

Methods and material for containment: absorb with liquid-binding material (e.g. sand, diatomaceous earth, acid- or universal binding agents).

5.4.   

Instructions for safe disposal of the product and its packaging

At the end of the application, dispose unused product and the packaging in accordance with local requirements.

Used product can be flushed to 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

Shelf life: 24 months

Do not store at temperatures above 40°C.

Keep away from heat and direct sunlight.

Protect from frost.

Keep container tightly closed.

6.   

OTHER INFORMATION

Not relevant

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

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 6

Use # 1 – Use # 6.1 - Teat-disinfection post-milking by manual or automated dipping or spraying

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

 (6)

OF THE META SPC 6

5.1.   

Instructions for use

The product must be brought to a temperature between 20°C and 30°C before use.

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

Fill in the dosing pump reservoir with the RTU product. Avoid discharge of surplus fluids.

Apply the product by manual or automated dipping or spraying. Make sure that the teats are fully covered with disinfectant. Application volumes for cows and buffaloes - 5 ml/treatment and for sheep and goats - 3 ml/treatment.

Leave the product on the teats until next milking. Keep the animals standing for at least 5 minutes after treatment.

After disinfection clean the application equipment by rinsing with water.

Keep out of reach of children.

5.2.   

Risk mitigation measures

Wear chemical goggles consistent with the European Standard EN ISO 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN ISO 374 or equivalent.

Goggles, gloves and coverall material to be specified by the authorisation holder within the product information.

This is without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.

5.3.   

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

First aid instructions

IF INHALED: if symptoms occur call a POISON CENTRE or a doctor.

IF ON SKIN: take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

IF IN EYES: immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112 or an ambulance for medical assistance.

IF SWALLOWED: immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

Emergency measure to protect the environment

Environmental precautions: no special environmental measures are necessary. Clean contaminated articles and floor in accordance with the environmental legislation.

Methods and material for containment: absorb with liquid-binding material (e.g. sand, diatomaceous earth, acid- or universal binding agents).

5.4.   

Instructions for safe disposal of the product and its packaging

At the end of the application, dispose unused product and the packaging in accordance with local requirements.

Used product can be flushed to municipal sewer or disposed to the manure deposit depending on local requirements.

5.5.   

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

Shelf life: 24 months

Do not store at temperatures above 40°C.

Keep away from heat and direct sunlight.

Protect from frost.

Keep container tightly closed.

6.   

OTHER INFORMATION

Not relevant

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 7

Use # 1 – Use # 7.1 – Hard surface disinfection by manual or automated foaming

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

 (7)

OF THE META SPC 7

5.1.   

Instructions for use

For fixed installations, connect the jerrycan, drum or IBC containing the product with the dosing unit of the satellite station. For mobile versions, place a 20 litres container of the neat product on the trolley and put the suction hose in. Connect water supply to the dosing unit. Dilution is performed automatically via the dosing unit of the fixed or mobile station and monitored by conductivity measurements.

Before disinfection remove loose dirt, any further precleaning is not necessary.

Apply the foam to the hard surfaces. Application volume is 350 ml of diluted product/m

2

. Make sure that surfaces are well covered with the disinfectant.

Minimum contact time is 5 minutes for bacteria and 15 minutes for yeasts.

After application, rinse treated surfaces and flush foaming equipment thoroughly with clean water. For flushing of mobile systems, put the suction hose into a container with clean water.

5.2.   

Risk mitigation measures

Wear chemical goggles consistent with the European Standard EN ISO 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN ISO 374 or equivalent.

Goggles, gloves and coverall material to be specified by the authorisation holder within the product information.

Wear respiratory protection when handling the concentrated product. Respiratory protection to be specified by the authorisation holder within the product information. Avoid standing in areas with aerosol formation.

This is without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.

5.3.   

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

First aid instructions

IF INHALED: move to fresh air and keep at rest in a position comfortable for breathing.

If symptoms: call 112 or an ambulance for medical assistance.

If no symptoms: call a POISON CENTRE or a doctor.

IF ON SKIN: immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

IF IN EYES: immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112 or an ambulance for medical assistance.

IF SWALLOWED: immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

Emergency measure to protect the environment

Environmental precautions: do not allow product to reach sewage systems or water bodies.

Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, universal binder). Do not use combustible material like sawdust. Dispose of the material collected in accordance with local regulations. Ensure adequate ventilation.

5.4.   

Instructions for safe disposal of the product and its packaging

At the end of the application, dispose unused product and the packaging in accordance with local requirements.

Used product can be flushed to municipal sewer 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

Shelf life: 24 months

Ensure good ventilation or exhaustion.

Do not store together with alkalis (caustic solutions).

Do not store at temperatures above 40°C.

Keep away from heat and direct sunlight.

Protect from frost.

Keep container tightly closed.

6.   

OTHER INFORMATION

Not relevant

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 8

Use # 1 – Use # 8.1 – Hard surface disinfection by automated spraying in closed cleaning in place (CIP) system

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

 (8)

OF THE META SPC 8

5.1.   

Instructions for use

Connect the jerrycan, drum or IBC containing the product with the dosing unit of the CIP system. Dosing and dilution are performed automatically via the dosing unit of the CIP system and monitored by conductivity measurements.

Avoid contact with aluminium, non-ferrous metals and galvanised materials.

Precleaning is not necessary.

Minimum contact time is 5 minutes for bacteria and 15 minutes for yeasts.

After application, rinse the treated system thoroughly with clean water.

5.2.   

Risk mitigation measures

Wear chemical goggles consistent with the European Standard EN ISO 16321 or equivalent, protective clothing chemically resistant to the biocidal product, chemical resistant gloves classified under the European Standard EN ISO 374 or equivalent.

Goggles, gloves and coverall material to be specified by the authorisation holder within the product information.

Wear respiratory protection when handling the concentrated product. Respiratory protection to be specified by the authorisation holder within the product information. Avoid standing in areas with aerosol formation.

This is without prejudice to the application of Directive 98/24/EC and other Union legislation in the area of health and safety at work.

5.3.   

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

First aid instructions

IF INHALED: move to fresh air and keep at rest in a position comfortable for breathing.

If symptoms: call 112 or an ambulance for medical assistance.

If no symptoms: call a POISON CENTRE or a doctor.

IF ON SKIN: immediately wash skin with plenty of water. Thereafter take off all contaminated clothing and wash it before reuse. Continue to wash the skin with water for 15 minutes. Call a POISON CENTRE or a doctor.

IF IN EYES: immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes. Call 112 or an ambulance for medical assistance.

IF SWALLOWED: immediately rinse mouth. Give something to drink, if exposed person is able to swallow. Do NOT induce vomiting. Call 112 or an ambulance for medical assistance.

Emergency measure to protect the environment

Environmental precautions: do not allow product to reach sewage systems or water bodies.

Methods and material for containment and cleaning up: absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose of the material collected in accordance with local regulations.

5.4.   

Instructions for safe disposal of the product and its packaging

At the end of the application, dispose unused product and the packaging in accordance with local requirements.

Used product can be flushed to municipal sewer depending on local requirements.

5.5.   

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

Shelf life: 24 months

Ensure good ventilation or exhaustion.

Do not store together with alkalis (caustic solutions).

Do not store at temperatures above 40°C.

Keep away from heat and direct sunlight.

Protect from frost.

Keep container tightly closed.

6.   

OTHER INFORMATION

Not relevant

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

7.2.   

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.

(4)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 4.

(5)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 5.

(6)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 6.

(7)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 7.

(8)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 8.