2025/524

24.3.2025

COMMISSION IMPLEMENTING REGULATION (EU) 2025/524

of 20 March 2025

granting a Union authorisation for the biocidal product family ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ 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 December 2018, Reckitt Benckiser Production submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ of product-types 2 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-NB046342-57 in the Register for Biocidal Products.

(2) ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ contains sodium hypochlorite 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 and 4.

(3) On 22 July 2021, 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 23 August 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ 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 ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ 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(6) of that Regulation.

(6) On 12 September 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) On 28 June 2023, in the meeting of the Standing Committee on Biocidal Products (the ‘Standing Committee’), concerns were expressed about the dietary risk assessment conducted by the evaluating competent authority and endorsed in the Agency’s opinion for the products of product-type 4. Those concerns related to the risk that the general public may be exposed to chlorate residues via the consumption of food in contact with disinfected surfaces and that that risk could only be mitigated by the introduction of a rinsing step after application of those products, while non-professional users cannot be expected to effectively implement such a risk mitigation measure.

(8) The applicant agreed to remove the use of the product as disinfectant for hard non-porous surfaces in the food and feed area by non-professional users of product-type 4 from the SPC and informed the Commission accordingly on 31 August 2023.

(9) On 27 September 2023, the Standing Committee endorsed the introduction of a rinsing step after the disinfection of hard non-porous surfaces in the food and feed area for product-type 4 only for professional users to comply with the chlorate limit values set out in Regulation (EC) No 396/2005 of the European Parliament and of the Council (3) and removal of the affected product-type 4 uses for non-professional users from the SPC.

(10) Except for the feasibility of the rinsing step to be performed by the non-professional users after the use of the product as disinfectant for hard non-porous surfaces in the food and feed area of product-type 4, the Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for the biocidal product family ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ excluding the use as disinfectant for hard non-porous surfaces in product-type 4 for non-professional users.

(11) In its opinion, the Agency recommends that the authorisation holder provides a test to determine whether the quantity of product delivered by the spray used to apply the products of meta-SPC F is always the same before and after two years of storage to ensure that the effective dose applied does not change after storage as a condition in the authorisation. The Commission agrees with that recommendation and considers that the submission of the results of that test should be a condition relating to the making available on the market and use of the biocidal product family ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ in products of meta-SPC F pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of that Regulation based on existing data.

(12) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0029289-0000 is hereby granted to Reckitt Benckiser Production for the making available on the market and use of the biocidal product family ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II.

The Union authorisation is valid from 13 April 2025 until 31 March 2035.

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, 20 March 2025.

For the Commission

The President

Ursula VON DER LEYEN

(1)  

OJ L 167, 27.6.2012, p. 1

, ELI: 

http://data.europa.eu/eli/reg/2012/528/oj

.

(2)  ECHA opinion of 19 August 2022 on the Union authorisation of ‘Sodium hypochlorite Liquid disinfectant biocidal product family’ (ECHA/BPC/349/2022),

https://echa.europa.eu/opinions-on-union-authorisation

.

(3)  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (

OJ L 70, 16.3.2005, p. 1

, ELI: 

http://data.europa.eu/eli/reg/2005/396/oj

).

ANNEX I

TERMS AND CONDITIONS (EU-0029289-0000)

The authorisation holder shall provide the particle size distribution delivered by the trigger spray TS6 after a long-term storage stability test (24 months) of a commercial sample of products in meta-SPC F (formula, bottle and trigger spray) as a condition for their authorisation.

By 13 April 2027 the authorisation holder shall submit the results of the test to the Agency.

ANNEX II

Summary of product characteristics for a biocidal product family

Sodium hypochlorite Liquid disinfectant biocidal product family

Product type(s)

PT02: Disinfectants and algaecides not intended for direct application to humans or animals

PT04: Food and feed area

Authorisation number

EU-0029289-0000

R4BP asset number

EU-0029289-0000

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 product

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)

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

4.1.   

Use description

Table 1.

Toilet bowl disinfection

4.1.1.   

Use-specific instructions

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 OF THE META SPC 1

5.1.   

Instructions for use

— Comply with the instruction for use.

— For healthcare settings: clean carefully the surfaces before application of the product.

— Respect the conditions of use of the product (concentration, contact time, temperature, etc.).

— Squeeze and apply slowly all around the inside of the bowl, allowing enough liquid to cover the bowl completely.

— The recommended dose is approximately 80 mL.

— Products should not be used in conjunction with acids or ammonia.

— No other cleaning agents should be used in conjunction with the product.

— Inform the registration holder if the treatment is ineffective.

5.2.   

Risk mitigation measures

For professional users:

Wear personal protective equipment during application of the products:

— chemical resistant gloves classified under EN 374 or equivalent;

— chemical goggles classified under EN 16321 or equivalent;

— protective coverall in accordance with EN 13034 or equivalent;

(material to be specified by the authorisation holder within the product information)

The full texts of the EN standards are available in Section 6

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.

For non-professional users:

— Do not touch the product during application

— Wash hands after use

— Avoid contact with skin and eyes

— Avoid splashes during application

5.3.   

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

— 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/ambulance for medical assistance.

— Information to Healthcare personnel/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/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 medical advice is needed, have product container or label at hand.

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: 24 months.

— Do not store above 30°C.

— Protect from direct sunlight.

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

6.   

OTHER INFORMATION

The full titles of the EN standards and legal act 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 13034 - Protective clothing against liquid chemicals - Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment)

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 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

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

4.1.   

Use description

Table 1.

Toilet bowl disinfection

4.1.1.   

Use-specific instructions

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 OF THE META SPC 2

5.1.   

Instructions for use

— Comply with the instruction for use.

— For healthcare settings: clean carefully the surfaces before application of the product.

— Respect the conditions of use of the product (concentration, contact time, temperature, etc.).

— Squeeze and apply slowly all around the inside of the bowl, allowing enough liquid to cover the bowl completely.

— The recommended dose is approximately 80 mL.

— Products should not be used in conjunction with acids or ammonia.

— No other cleaning agents should be used in conjunction with the product.

— Inform the registration holder if the treatment is ineffective.

5.2.   

Risk mitigation measures

For professional users:

Wear personal protective equipment during application of the products:

— chemical resistant gloves classified under EN 374 or equivalent;

— chemical goggles classified under EN 16321 or equivalent;

— protective coverall in accordance with EN 13034 or equivalent.

(material to be specified by the authorisation holder within the product information)

The full texts of the EN standards are available in Section 6

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.

For non-professional users:

— Do not touch the product during application

— Wash hands after use

— Avoid contact with skin and eyes

— Avoid splashes during application

5.3.   

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

— 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/ambulance for medical assistance.

— Information to Healthcare personnel/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/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 medical advice is needed, have product container or label at hand.

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: 18 months.

— Do not store above 30°C.

— Protect from direct sunlight.

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

6.   

OTHER INFORMATION

The full titles of the EN standards and legal act 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 13034 - Protective clothing against liquid chemicals - Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment)

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

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

4.1.   

Use description

Table 1.

Toilet bowl disinfection

4.1.1.   

Use-specific instructions

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 OF THE META SPC 3

5.1.   

Instructions for use

— Comply with the instruction for use.

— For healthcare settings: clean carefully the surfaces before application of the product.

— Respect the conditions of use of the product (concentration, contact time, temperature, etc.).

— Squeeze and apply slowly all around the inside of the bowl, allowing enough liquid to cover the bowl completely.

— The recommended dose is approximately 80 mL.

— Products should not be used in conjunction with acids or ammonia.

— No other cleaning agents should be used in conjunction with the product.

— Inform the registration holder if the treatment is ineffective.

5.2.   

Risk mitigation measures

For professional users:

Wear personal protective equipment during application of the products:

— chemical resistant gloves classified under EN 374 or equivalent;

— chemical goggles classified under EN 16321 or equivalent;

— protective coverall in accordance with EN 13034 or equivalent.

— (material to be specified by the authorisation holder within the product information)

The full texts of the EN standards are available in Section 6

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.

For non-professional users:

— Do not touch the product during application

— Wash hands after use

— Avoid contact with skin and eyes

— Avoid splashes during application

5.3.   

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

— 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/ambulance for medical assistance.

— Information to Healthcare personnel/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/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 medical advice is needed, have product container or label at hand.

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: 24 months.

— Do not store above 30°C.

— Protect from direct sunlight.

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

6.   

OTHER INFORMATION

The full titles of the EN standards and legal act 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 13034 - Protective clothing against liquid chemicals - Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment)

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 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

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

4.1.   

Use description

Table 1.

Drain pipe surface disinfection

4.1.1.   

Use-specific instructions

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 OF THE META SPC 4

5.1.   

Instructions for use

— Comply with the instruction for use.

— Respect the conditions of use of the product (concentration, contact time, temperature, etc.).

— The recommended dose is approximately 250 mL which the user is guided to measure based on a proportion of the pack size:

— For 750 mL: Use sufficient liquid to thoroughly coat the pipe. This may require 1/3rd of the contents.

— For 500 mL: Carefully uncap and without squeezing the bottle, pour gently ½ bottle of gel into the drain.

— For 1 L: Carefully uncap and without squeezing the bottle, pour gently ¼ bottle of gel into the drain.

— Once a week maximum.

— Product to be applied by the user by placing bottle near to the drain hole and pouring product down the drain.

— Rinse thoroughly after use.

— No other cleaning agents should be used in conjunction with the product.

— Inform the registration holder if the treatment is ineffective.

5.2.   

Risk mitigation measures

For professional users:

Wear personal protective equipment during application of the products:

— chemical resistant gloves classified under EN 374 or equivalent ;

— chemical goggles classified under EN 16321 or equivalent ;

— protective coverall in accordance with EN 13034 or equivalent;

(material to be specified by the authorisation holder within the product information)

The full texts of the EN standards are available in Section 6

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.

For non-professional users:

— Do not touch the product during application

— Wash hands after use

— Avoid contact with skin and eyes.

5.3.   

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

— 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/ambulance for medical assistance.

— Information to Healthcare personnel/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/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 medical advice is needed, have product container or label at hand.

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: 24 months.

— Do not store above 30°C.

— Protect from direct sunlight.

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

6.   

OTHER INFORMATION

The full titles of the EN standards and legal act 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 13034 - Protective clothing against liquid chemicals - Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment)

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 4

7.1.   

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

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

4.1.   

Use description

Table 1.

Drain pipe surface disinfection

4.1.1.   

Use-specific instructions

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 OF THE META SPC 5

5.1.   

Instructions for use

— Comply with the instruction for use.

— Respect the conditions of use of the product (concentration, contact time, temperature, etc.).

— The recommended dose is approximately 125 mL which the user is guided to measure based on a proportion of the pack size:

— For 750 mL (without bottle handle): Carefully squeeze bottle to apply the liquid directly into the drain until all surfaces are covered (approximately. 125 mL).

— For 500 mL, 750 mL, 1 L, 1.5 L & 2 L (bottle with handle): Carefully uncap and without squeezing the bottle, carefully pour the gel into the drain until all surfaces are covered (approximately 125 mL).

— Once a week maximum.

— Product to be applied by the user by placing bottle near to the drain hole and pouring product down the drain.

— Rinse thoroughly after use.

— Products should not be used in conjunction with acids or ammonia

— Inform the registration holder if the treatment is ineffective.

5.2.   

Risk mitigation measures

For professional users:

Wear personal protective equipment during application of the products:

— chemical resistant gloves classified under EN 374 or equivalent;

— chemical goggles classified under EN 16321 or equivalent ;

— protective coverall in accordance with EN 13034 or equivalent;

(material to be specified by the authorisation holder within the product information)

The full texts of the EN standards are available in Section 6

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.

For non-professional users:

— Do not touch the product during application

— Wash hand after use

— Avoid contact with skin and eyes

5.3.   

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

— 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/ambulance for medical assistance.

— Information to Healthcare personnel/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/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 medical advice is needed, have product container or label at hand.

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: 24 months.

— Do not store above 30°C.

— Protect from direct sunlight.

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

6.   

OTHER INFORMATION

The full titles of the EN standards and legal act 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 13034 - Protective clothing against liquid chemicals - Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment)

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 5

7.1.   

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

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

4.1.   

Use description

Table 1.

Hard non porous surface disinfection

4.1.1.   

Use-specific instructions

See general directions for use.

4.1.2.   

Use-specific risk mitigation measures

For non-professional users:

— Product shall be sprayed downward

— Wash hands after use

— Avoid contact with skin and eyes

For secondary exposure of general public:

— It shall be ensured that bystanders and general public do not touch the surface until the surface is rinsed and dry.

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.

Hard non porous surface disinfection

4.2.1.   

Use-specific instructions

See general directions for use.

4.2.2.   

Use-specific risk mitigation measures

See general directions for use.

For food commodities, ensure that the concentration of chlorate present in food does not exceed the MRL values set in Regulation 2020/749. See section 6 for the full reference to this act.

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 OF THE META SPC 6

5.1.   

Instructions for use

— Comply with the instruction for use. Respect the conditions of use of the product (concentration, contact time, temperature, etc.).

— Ensure complete wetting on the surfaces, leave for appropriate contact time.

— Product to be applied to hard surfaces by spraying. The nozzle of the product should be turned to the ‘ ‘on’ ’ position. Users are advised to spray product 20-25 cm away from surfaces.

— Rinse treated surfaces after application.

— Products should not be used in conjunction with acids or ammonia.

— Inform the registration holder if the treatment is ineffective.

5.2.   

Risk mitigation measures

For professional users:

Wear personal protective equipment during application and post-application of the products:

— chemical resistant gloves classified under EN 374 or equivalent;

— chemical googles classified under EN 16321 or equivalent;

— protective coverall in accordance with EN 13034 or equivalent.

(material to be specified by the authorisation holder within the product information)

The full texts of the EN standards are available in Section 6

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

— 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.

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

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

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: 24 months.

— Do not store above 30°C.

— Protect from direct sunlight.

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

6.   

OTHER INFORMATION

The full titles of the EN standards and legal act 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 13034 - Protective clothing against liquid chemicals - Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment)

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

).

The full title of the legal act mentioned in Section 4.2.2 ‘Use-specific risk mitigation measures’ is:

Commission Regulation (EU) 2020/749 of 4 June 2020 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorate in or on certain products (

OJ L 178, 8.6.2020, p. 7–20

).

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

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

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

4.1.   

Use description

Table 1.

Hard non porous surface disinfection

4.1.1.   

Use-specific instructions

See general directions for use.

4.1.2.   

Use-specific risk mitigation measures

See general directions for use.

PT4: For food commodities, ensure that the concentration of chlorate present in food does not exceed the MRL values set in Regulation 2020/749. See section 6 for the full reference to this act.

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 OF THE META SPC 7

5.1.   

Instructions for use

— Comply with the instruction for use.

— For healthcare settings: clean carefully the surfaces before application of the product.

— Respect the conditions of use of the product (concentration, contact time, temperature, etc.).

— Ensure complete wetting on the surfaces, leave for appropriate contact time.

— Product to be applied to hard surfaces by spraying. The nozzle of the product should be turned to the ‘ ‘on’ ’ position. Users are advised to spray product 20-25cm away from surfaces, whilst keeping product upright.

— Rinse treated surfaces after application.

— Products should not be used in conjunction with acids or ammonia.

— Inform the registration holder if the treatment is ineffective.

5.2.   

Risk mitigation measures

For professional users:

Wear personal protective equipment during application and post-application of the products:

— chemical resistant gloves classified under EN 374 or equivalent ;

— chemical goggles classified under EN 16321 or equivalent ;

— protective coverall in accordance with EN 13034 or equivalent;

(material to be specified by the authorisation holder within the product information)

— Respiratory protective equipment (only during spraying) in accordance with EN 14387 or equivalent

The full texts of the EN standards are available in Section 6

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.

For the bystander:

— Do not be present in the treatment area during application by spraying. If it is necessary to be present, wear same RPE and PPE as the user.

— For secondary exposure of general public:

— By-standers shall not be present during application by spraying

— It shall be ensured that bystanders and general public do not touch the surface until the surface is rinsed and dry.

5.3.   

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

— 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/ambulance for medical assistance.

— Information to Healthcare personnel/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/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.

— Keep the container or label available.

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: 24 months.

— Do not store above 30°C.

— Protect from direct sunlight.

6.   

OTHER INFORMATION

The full titles of the EN standards and legal act 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 13034 - Protective clothing against liquid chemicals - Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment)

EN 14387 - Respiratory protective devices - Gas filter(s) and combined filter(s)- Requirements, testing, marking

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

).

Commission Regulation (EU) 2020/749 of 4 June 2020 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorate in or on certain products (

OJ L 178, 8.6.2020, p. 7–20

).

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

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

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

4.1.   

Use description

Table 1.

Hard non porous surface disinfection

4.1.1.   

Use-specific instructions

See general directions for use.

4.1.2.   

Use-specific risk mitigation measures

For non-professional users:

— Product shall be sprayed downward

— Wash hand after use

— Avoid contact with skin and eyes

For secondary exposure of general public:

— It shall be ensured that bystanders and general public do not touch the surface until the surface is rinsed and dry.

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.

Hard non porous surface disinfection

4.2.1.   

Use-specific instructions

See general directions for use.

4.2.2.   

Use-specific risk mitigation measures

See general directions for use.

For food commodities, ensure that the concentration of chlorate present in food does not exceed the MRL values set in Regulation 2020/749. See section 6 for the full reference to this act.

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 OF THE META SPC 8

5.1.   

Instructions for use

— Comply with the instruction for use.

— For healthcare settings: clean carefully the surfaces before application of the product.

— Respect the conditions of use of the product (concentration, contact time, temperature, etc.).

— Ensure complete wetting on the surfaces, leave for appropriate contact time.

— Product is to be applied by spraying. The nozzle of the product should be turned to the ‘on’ position. Users are advised to spray product 20-25cm away from surfaces.

— Rinse treated surfaces after application.

— Products should not be used in conjunction with acids or ammonia.

— Inform the registration holder if the treatment is ineffective.

5.2.   

Risk mitigation measures

For professional users:

Wear personal protective equipment during application and post-application of the products:

— chemical resistant gloves classified under EN 374 or equivalent ;

— chemical goggles classified under EN 16321 or equivalent ;

— protective coverall in accordance with EN 13034 or equivalent;

(material to be specified by the authorisation holder within the product information)

The full texts of the EN standards are available in Section 6

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

— 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.

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

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

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: 24 months.

— Do not store above 30°C.

— Protect from direct sunlight.

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

6.   

OTHER INFORMATION

The full titles of the EN standards and legal act 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 13034 - Protective clothing against liquid chemicals - Performance requirements for chemical protective clothing offering limited protective performance against liquid chemicals (Type 6 and Type PB [6] equipment)

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

).

The full title of the legal act mentioned in Section 4.2.2 ‘Use-specific risk mitigation measures’ is:

Commission Regulation (EU) 2020/749 of 4 June 2020 amending Annex III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for chlorate in or on certain products (

OJ L 178, 8.6.2020, p. 7–20

).

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

7.3.   

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

1.   

META SPC 9 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 9 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   

META SPC 9 COMPOSITION

2.1.   

Qualitative and quantitative information on the composition of the meta SPC 9

2.2.   

Type(s) of formulation of the meta SPC 9

3.   

HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 9

4.   

AUTHORISED USE(S) OF THE META SPC

4.1.   

Use description

Table 1.

Toilet bowl disinfection

4.1.1.   

Use-specific instructions

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 OF THE META SPC 9

5.1.   

Instructions for use

— Comply with the instruction for use.

— For healthcare settings: clean carefully the surfaces before application of the product.

— Respect the conditions of use of the product (concentration, contact time, temperature, etc.).

— Squeeze and apply slowly all around the inside of the bowl, allowing enough liquid to cover the bowl completely.

— The recommended dose is approximately 80 mL.

— Products should not be used in conjunction with acids or ammonia.

— No other cleaning agents should be used in conjunction with the product.

— Inform the registration holder if the treatment is ineffective.

5.2.   

Risk mitigation measures

For professional users:

Wear personal protective equipment during application of the products:

— chemical resistant gloves classified under EN 374 or equivalent;

— chemical goggles classified under EN 16321 or equivalent ;

— protective coverall in accordance with EN 13034 or equivalent;

(material to be specified by the authorisation holder within the product information)

The full texts of the EN standards are available in Section 6.

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.

For non-professional users:

— Do not touch the product during application

— Wash hands after use

— Avoid contact with skin and eyes

— Avoid splashes during application

5.3.   

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

— 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/ambulance for medical assistance.

— Information to Healthcare personnel/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/ambulance for medical assistance.