COMMISSION IMPLEMENTING REGULATION (EU) 2023/1763

of 12 September 2023

granting a Union authorisation for the biocidal product family ‘Lactic acid Family – Quatchem’ 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 14 April 2019, Arrow Regulatory (Ireland) Limited submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘Lactic acid Family – Quatchem’ of product-type 3, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Latvia had agreed to evaluate the application. The application was recorded under case number BC-WC050857-29 in the Register for Biocidal Products.

(2) ‘Lactic acid Family – Quatchem’ 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-type 3.

(3) On 16 May 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 13 December 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Lactic acid Family – Quatchem’ 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 ‘Lactic acid Family – Quatchem’ 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 5 January 2023, 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 ‘Lactic acid Family – Quatchem’.

(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-0030143-0000 is hereby granted to Arrow Regulatory (Ireland) Limited for the making available on the market and use of the biocidal product family ‘Lactic acid Family – Quatchem’ subject to compliance with the terms and conditions set out in the Annex.

The Union authorisation is valid from 3 October 2023 to 30 September 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, 12 September 2023.

For the Commission

The President

Ursula VON DER LEYEN

(1)  

OJ L 167, 27.6.2012, p. 1

.

(2)  ECHA opinion of 24 November 2022 on the Union authorisation of ‘Lactic acid Family – Quatchem’ (ECHA/BPC/371/2022), https://echa.europa.eu/opinions-on-union-authorisation.

ANNEX

Summary of product characteristics for a biocidal product family

Lactic acid Family - Quatchem

Product type 3 - Veterinary hygiene (Disinfectants)

Authorisation number: EU-0030143-0000

R4BP asset number: EU-0030143-0000

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 – Post milking teat disinfection – manual dipping

4.1.1.   

Use-specific instructions for use

See general directions for use.

Product to be applied post-milking by use of a dipping cup.

Pre-clean teat with dry wipe, pour the product into the reservoir of the dip cup. When using a dip cup, the cup is applied to each teat in turn and the operator squeezes the product from the reservoir into the cup. The cup has a non-return value so any residual product cannot go back into the reservoir.

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.

4.2.   

Use description

Table 2.

Use # 2 – Use # 1.2 – Post milking teat disinfection - spraying

4.2.1.   

Use-specific instructions for use

See general directions for use.

Product to be applied post-milking by use of a hand-held sprayer.

Pre-clean teat with dry wipe, pour the product into the reservoir of the sprayer. The operator will spray each animal once after milking.

4.2.2.   

Use-specific risk mitigation measures

See general directions for use.

Professional users have to ensure that professional bystanders are not present in the treatment area during disinfection process by spraying. If it is necessary for professional bystanders to be present, professional users have to ensure that those bystanders wear the same type of PPE as the operator.

4.2.3.   

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

See general directions for use.

4.2.4.   

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

See general directions for use.

4.2.5.   

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

See general directions for use.

5.   

GENERAL DIRECTIONS FOR USE

 (1)

OF THE META SPC 1

5.1.   

Instructions for use

See use-specific instruction for use of meta SPC 1.

Always read the label or leaflet before use.

The product must be brought to room temperature before use. The amount of product applied per teat is dependent upon the animal being treated. For large mammals (cows, camels) – up to 10 ml per teat, and for small mammals (sheep, goats) – up to 5 ml per teat. Make sure that the teats are fully covered with disinfectant. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing for at least 5 minutes).

5.2.   

Risk mitigation measures

The use of eye protection consistent with European standard EN ISO 16321 or equivalent during handling of the product is mandatory.

Avoid hand to eye transfer.

Wear protective chemical resistant gloves during product handling phase (nitrile gloves – classified under European standards EN ISO 374 or EN 455 or equivalent).

The full titles of the European standards indicated here are available under section 6.

5.3.   

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

IF ON SKIN: Immediately wash 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/ambulance for medical assistance.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.

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

5.4.   

Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose of unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

5.5.   

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

 

Keep out of reach of children.

 

Store in original container tightly closed.

 

Store between 0 °C and + 30 °C.

 

Shelf life: 24 months

6.   

OTHER INFORMATION

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

 

EN ISO 16321 - Eye and face protection for occupational use

 

EN ISO 374 – Protective gloves against dangerous chemicals and microorganisms

 

EN 455 - Medical gloves for single use

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 3.

Use # 1 – Use # 3.1 – Post milking teat disinfection – manual dipping

4.1.1.   

Use-specific instructions for use

See general directions for use.

Product to be applied post-milking by use of a dipping cup.

Pre-clean teat with dry wipe, pour the product into the reservoir of the dip cup. When using a dip cup, the cup is applied to each teat in turn and the operator squeezes the product from the reservoir into the cup. The cup has a non-return value so any residual product cannot go back into the reservoir.

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.

4.2.   

Use description

Table 4.

Use # 2 – Use # 3.2 – Post milking teat disinfection - spraying

4.2.1.   

Use-specific instructions for use

See general directions for use.

Product to be applied post-milking by use of a hand-held sprayer.

Pre-clean teat with dry wipe, pour the product into the reservoir of the sprayer. The operator will spray each animal once after milking.

4.2.2.   

Use-specific risk mitigation measures

See general directions for use.

Professional users have to ensure that professional bystanders are not present in the treatment area during disinfection process by spraying. If it is necessary for professional bystanders to be present, professional users have to ensure that those bystanders wear the same type of PPE as the operators.

4.2.3.   

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

See general directions for use.

4.2.4.   

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

See general directions for use.

4.2.5.   

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

See general directions for use.

5.   

GENERAL DIRECTIONS FOR USE

 (2)

OF THE META SPC 2

5.1.   

Instructions for use

See use-specific instruction for use of meta SPC 2.

Always read the label or leaflet before use.

The product must be brought to room temperature before use. The amount of product applied per teat is dependent upon the animal being treated. For large mammals (cows, camels) – up to 10 ml per teat, and for small mammals (sheep, goats) – up to 5 ml per teat. Make sure that the teats are fully covered with disinfectant. To ensure sufficient contact time, care should be taken that the product is not removed after application (e.g. keep the cows standing for at least 5 minutes).

5.2.   

Risk mitigation measures

The use of eye protection consistent with European standard EN ISO 16321 or equivalent during handling of the product is mandatory.

Avoid hand to eye transfer.

Wear protective chemical resistant gloves during product handling phase (nitrile gloves – classified under European standards EN ISO 374 or EN 455 or equivalent).

The full titles of the European standards indicated here are available under section 6.

5.3.   

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

IF ON SKIN: Immediately wash 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/ambulance for medical assistance.

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. If symptoms: Call 112/ambulance for medical assistance. If no symptoms: Call a POISON CENTRE or a doctor.

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

5.4.   

Instructions for safe disposal of the product and its packaging

At the end of the treatment, dispose of unused product and the packaging in accordance with local requirements. Used product can be flushed to the municipal sewer or disposed to the manure deposit depending on local requirements. Avoid release to an individual waste water treatment plant.

5.5.   

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

 

Keep out of reach of children.

 

Store in original container tightly closed.

 

Store between 0 °C and + 30 °C.

 

Shelf life: 24 months

6.   

OTHER INFORMATION

The full titles of the EN standards referred to in section 5.2 are the following:

 

EN ISO 16321 - Eye and face protection for occupational use

 

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

 

EN 455 - Medical gloves for single use

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

(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.