COMMISSION IMPLEMENTING REGULATION (EU) 2023/1758

of 11 September 2023

granting a Union authorisation for the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ 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 26 April 2019, Salveco SAS 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 ‘SALVECO SALVESAFE PRODUCTS’ of product-types 2, 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-HC051278-51 in the Register for Biocidal Products.

(2) ‘SALVECO SALVESAFE PRODUCTS’ 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 2, 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 ‘SALVECO SALVESAFE PRODUCTS’ 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 ‘SALVECO SALVESAFE PRODUCTS’ 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 the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’.

(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-0028967-0000 is hereby granted to Salveco SAS for the making available on the market and use of the biocidal product family ‘SALVECO SALVESAFE PRODUCTS’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 2 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, 11 September 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 ‘SALVECO SALVESAFE PRODUCTS’ (ECHA/BPC/346/2022), https://echa.europa.eu/opinions-on-union-authorisation.

ANNEX

SUMMARY OF PRODUCT CHARACTERISTICS FOR A BIOCIDAL PRODUCT FAMILY

SALVECO SALVESAFE PRODUCTS

Product type 2 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Product type 3 - Veterinary hygiene (Disinfectants)

Product type 4 - Food and feed area (Disinfectants)

Authorisation number: EU-0028967-0000

R4BP asset number: EU-0028967-0000

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 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional, medical and industrial areas)

4.1.1.   

Use-specific instructions for use

See general instructions for use.

4.1.2.   

Use-specific risk mitigation measures

See general instructions 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 instructions for use.

4.1.4.   

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

See general instructions 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 instructions for use.

4.2.   

Use description

Table 2

Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and food industry areas

4.2.1.   

Use-specific instructions for use

See general instructions for use.

4.2.2.   

Use-specific risk mitigation measures

See general instructions 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 general instructions for use.

4.2.4.   

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

See general instructions 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 instructions for use.

5.   

GENERAL DIRECTIONS FOR USE

 (1)

OF THE META SPC 1

5.1.   

Instructions for use

— Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m

2

or 20 ml/m

2

or fully cover the object to be disinfected).

— Apply only on non-porous surfaces.

— Inform the authorisation holder if the treatment is ineffective.

— Comply with the instructions for use.

— Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 15,66% to 31,33%, it is not possible to indicate all product dilution here.

The authorisation holder shall indicate on the label the relevant volume of product to be diluted in water for each specific product.

5.2.   

Risk mitigation measures

— Wash hands after use of the concentrate product.

— Avoid contact with eyes.

— Avoid splashes and spills during mixing and loading (dilution).

— For outdoor uses, do not apply the product in case rain is expected within 24 hours.

— For outdoor uses by spray, avoid transfer to other areas by wind (drift).

For professional use only:

— Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full texts of the EN standards are available in Section 6. – Personal protective equipment (PPE) material to be specified by the authorisation holder within the product information.

For non-professional use only:

— A child-proof closure is required.

— Keep out of reach of children and non-target animals or pets.

5.3.   

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

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

— 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.

Information to healthcare personnel or a doctor:

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid.

— 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.

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

5.4.   

Instructions for safe disposal of the product and its packaging

— Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.

— Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   

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

— Keep out of reach of children and non-target animals or pets.

— Shelf-life: 2 years.

— Protect from frost.

6.   

OTHER INFORMATION

— P280 (Wear protective gloves/protective clothing/eye protection/face protection) is not applicable for the non-professional user.

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:

 

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

 

EN 16321 - Eye and face protection for occupational use

 

EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

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 3

Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional, medical and industrial areas)

4.1.1.   

Use-specific instructions for use

See general instructions for use

4.1.2.   

Use-specific risk mitigation measures

See general instructions 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 instructions for use

4.1.4.   

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

See general instructions 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 instructions for use

4.2.   

Use description

Table 4

Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in domestic, institutional and food industry areas)

4.2.1.   

Use-specific instructions for use

See general instructions for use

4.2.2.   

Use-specific risk mitigation measures

See general instructions 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 general instructions for use

4.2.4.   

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

See general instructions 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 instructions for use

5.   

GENERAL DIRECTIONS FOR USE

 (2)

OF THE META SPC 2

5.1.   

Instructions for use

— Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m

2

or 20 ml/m

2

or fully cover the object to be disinfected).

— Apply only on non porous surfaces.

— Inform the authorisation holder if the treatment is ineffective.

— Comply with the instructions for use.

— Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 15,66% to 31,33%, it is not possible to indicate all product dilution here.

The authorisation holder shall indicate on the label the relevant volume of product to be diluted in water on the label of each specific product.

5.2.   

Risk mitigation measures

— Wash hands after use of the concentrate product.

— Avoid contact with eyes

— Avoid splashes and spills during mixing and load ing (dilution).

— For outdoor uses, do not apply the product in case rain is expected within 24 hours.

— For outdoor uses by spray, avoid transfer to other areas by wind (drift).

For professional use only:

— Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titles of the EN standards are available in Section 6. – PPE material to be specified by the authorisation holder within the product information.

For non-professional use only:

— A child-proof closure is required.

— Keep out of reach of children and non-target animals or pets.

5.3.   

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

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

— IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation or rash occur: 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.

Information to healthcare personnel or doctor:

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid

— 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.

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

5.4.   

Instructions for safe disposal of the product and its packaging

— Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.

— Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   

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

— Keep out of reach of children and non-target animals or pets.

— Shelf-life: 2 years.

— Protect from frost.

6.   

OTHER INFORMATION

— P280 is not applicable for the non-professional user.

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:

 

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

 

EN 16321 - Eye and face protection for occupational use

 

EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

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

7.5.   

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

7.6.   

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

7.7.   

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

7.8.   

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

7.9.   

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

7.10.   

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

7.11.   

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

7.12.   

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 5

Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in institutional, and industrial areas)

4.1.1.   

Use-specific instructions for use

See general instructions for use

4.1.2.   

Use-specific risk mitigation measures

See general instructions 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 instructions for use

4.1.4.   

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

See general instructions 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 instructions for use

4.2.   

Use description

Table 6

Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial areas)

4.2.1.   

Use-specific instructions for use

See general instructions for use

4.2.2.   

Use-specific risk mitigation measures

See general instructions 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 general instructions for use

4.2.4.   

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

See general instructions 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 instructions for use

5.   

GENERAL DIRECTIONS FOR USE

 (3)

OF THE META SPC 3

5.1.   

Instructions for use

— Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m

2

or 20 ml/m

2

or fully cover the object to be disinfected).

— Apply only on non-porous surfaces.

— Inform the auhtorisation holder if the treatment is ineffective.

— Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 7,83% to 31,33%, it is not possible to indicate all product dilution here.

The authorisation holder shall indicate on the label the relevant volume of product to be diluted in water on the label of each specific product.

5.2.   

Risk mitigation measures

— Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6.

— PPE material to be specified by the authorisation holder within the product information.

— Wash hands after use of the concentrate product.

— Avoid contact with eyes.

— Avoid splashes and spills during mixing and loading (dilution).

— For outdoor uses, do not apply the product in case rain is expected within 24 hours.

— For outdoor uses by spray, avoid transfer to other areas by wind (drift).

5.3.   

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

— 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.

Information to healthcare personnel or a doctor:

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid

— 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.

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

5.4.   

Instructions for safe disposal of the product and its packaging

— Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.

— Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   

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

— Shelf-life: 2 years.

— Protect from frost.

6.   

OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:

 

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

 

EN 16321 - Eye and face protection for occupational use

 

EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

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

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 7

Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in institutional and industrial areas)

4.1.1.   

Use-specific instructions for use

See general instructions for use

4.1.2.   

Use-specific risk mitigation measures

See general instructions 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 instructions for use

4.1.4.   

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

See general instructions 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 instructions for use

4.2.   

Use description

Table 8

Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial areas)

4.2.1.   

Use-specific instructions for use

See general instructions for use

4.2.2.   

Use-specific risk mitigation measures

See general instructions 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 general instructions for use

4.2.4.   

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

See general instructions 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 instructions for use

5.   

GENERAL DIRECTIONS FOR USE

 (4)

OF THE META SPC 4

5.1.   

Instructions for use

— Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m

2

or 20 ml/m

2

or fully cover the object to be disinfected).

— Apply only on non porous surfaces.

— Inform the authorisation holder if the treatment is ineffective.

— Each product label shall give information on how the dilution should be made in order to guarantee the efficacy of the product. Since the concentration of L-(+)-lactic acid in products within this meta SPC can range from 7,83% to 31,33%, it is not possible to indicate all product dilution here.

The authorisation holder shall indicate on the label the relevant volume of product to be diluted in water on the label of each specific product.

5.2.   

Risk mitigation measures

— Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6.

— PPE material to be specified by the authorisation holder within the product information.

— Wash hands after use of the concentrate product.

— Avoid contact with eyes.

— Avoid splashes and spills during mixing and loading (dilution).

— For outdoor uses, do not apply the product in case rain is expected within 24 hours.

— For outdoor uses by spray, avoid transfer to other areas by wind (drift).

5.3.   

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

— IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation or rash occur: 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.

Information to healthcare personnel or a doctor:

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid

— 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.

— IF INHALED: If symptoms occur call a POISON CENTER or a doctor.

5.4.   

Instructions for safe disposal of the product and its packaging

— Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.

— Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   

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

— Shelf-life: 2 years.

— Protect from frost.

6.   

OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:

 

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

 

EN 16321 - Eye and face protection for occupational use

 

EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

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

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 9

Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in institutional, medical, and industrial areas)

4.1.1.   

Use-specific instructions for use

See general instructions for use

4.1.2.   

Use-specific risk mitigation measures

See general instructions 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 instructions for use

4.1.4.   

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

See general instructions 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 instructions for use

4.2.   

Use description

Table 10

Use # 2 – Food and feed area disinfectants (disinfectant for all washable hard surfaces in institutional and industrial (food industry) areas)

4.2.1.   

Use-specific instructions for use

See general instructions for use

4.2.2.   

Use-specific risk mitigation measures

See general instructions 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 general instructions for use

4.2.4.   

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

See general instructions 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 instructions for use

4.3.   

Use description

Table 11

Use # 3 – Disinfectants used to disinfect the materials and surfaces associated with the housing of animals (disinfectants for all washable hard surfaces in veterinary area)

4.3.1.   

Use-specific instructions for use

— Clean carefully the surfaces before application of the product.

4.3.2.   

Use-specific risk mitigation measures

See general instructions 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 general instructions for use

4.3.4.   

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

See general instructions 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 general instructions for use

5.   

GENERAL DIRECTIONS FOR USE

 (5)

OF THE META SPC 5

5.1.   

Instructions for use

— Apply the product by fully wetting all surface for 5 to 30 minutes (apply approx. 18 sprays /m

2

or 20 ml/m

2

or fully cover the object to be disinfected).

— Apply only on non-porous surfaces.

— Inform the auhtorisation holder if the treatment is ineffective.

5.2.   

Risk mitigation measures

— Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6.

— PPE material to be specified by the authorisation holder within the product information.

— Wash hands after use of the concentrate product.

— Avoid contact with eyes.

— Avoid splashes and spills during mixing and loading (dilution).

— For outdoor uses, do not apply the product in case rain is expected within 24 hours.

— For outdoor uses by spray, avoid transfer to other areas by wind (drift).

5.3.   

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

— 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.

Information to healthcare personnel or a doctor:

The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid

— 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.

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

5.4.   

Instructions for safe disposal of the product and its packaging

— Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.

— Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   

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

— Shelf-life: 2 years.

— Protect from frost.

6.   

OTHER INFORMATION

— The product is a foaming formulation.

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:

 

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

 

EN 16321 - Eye and face protection for occupational use

 

EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

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 12

Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in medical area)

4.1.1.   

Use-specific instructions for use

See general instructions for use

4.1.2.   

Use-specific risk mitigation measures

See general instructions 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 instructions for use

4.1.4.   

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

See general instructions 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 instructions for use

5.   

GENERAL DIRECTIONS FOR USE

 (6)

OF THE META SPC 6

5.1.   

Instructions for use

— Apply the product by fully wetting all surface for 5 minutes (apply approx. 18 sprays /m

2

or 20 ml/m

2

or fully cover the object to be disinfected).

— Apply only on non porous surfaces.

— Inform the authorisation holder if the treatment is ineffective.

5.2.   

Risk mitigation measures

— Wear protective chemical resistant gloves classified under EN 374 or equivalent, chemical goggles consistent with EN 16321 or equivalent and a coverall consistent with EN 14605 or equivalent when handling the concentrate product (during dilution). The full titless of the EN standard are available under section 6.

— PPE material to be specified by the authorisation holder within the product information.

— Wash hands after use of the concentrate product.

— Avoid contact with eyes.

— Avoid splashes and spills during mixing and loading (dilution).

— For outdoor uses, do not apply the product in case rain is expected within 24 hours.

— For outdoor uses by spray, avoid transfer to other areas by wind (drift).

5.3.   

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

— IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation or rash occur: 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.

Information to healthcare personnel or a doctor:

— The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid

— 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.

— IF INHALED: If symptoms occur call a POISON CENTRE or a doctor

5.4.   

Instructions for safe disposal of the product and its packaging

— Do not discharge unused product on the ground, into water courses, into pipes (sink, toilets…) nor down the drains.

— Dispose of unused product, its packaging and all other waste, in accordance with local regulations.

5.5.   

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

— Shelf-life: 2 years.

— Protect from frost.

6.   

OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 "Risk mitigation measures" are:

 

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

 

EN 16321 - Eye and face protection for occupational use

 

EN 14605 - Protective clothing against liquid chemicals - Performance requirements for clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing protection to parts of the body only (Types PB [3] and PB [4])

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 13

Use # 1 – Disinfectants not intended for direct application to humans or animals (disinfectants for all washable hard surfaces in domestic, institutional and industrial areas)

4.1.1.   

Use-specific instructions for use