COMMISSION IMPLEMENTING REGULATION (EU) 2022/964

of 10 June 2022

granting a Union authorisation for the biocidal product family ‘SOPUROXID’

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

Whereas:

(1) On 1 September 2017, SOPURA N.V. submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘SOPUROXID’ of product-types 2, 3 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Belgium had agreed to evaluate the application. The application was recorded under case number BC-KV033704-17 in the Register for Biocidal Products.

(2) ‘SOPUROXID’ contains peracetic acid, as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.

(3) On 27 August 2020, 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 European Chemicals Agency (‘the Agency’).

(4) On 31 March 2021, the Agency submitted to the Commission an opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘SOPUROXID’ 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 ‘SOPUROXID’ 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 28 April 2021, 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 ‘SOPUROXID’.

(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-0026179-0000 is granted to SOPURA N.V. for the making available on the market and use of the biocidal product family ‘SOPUROXID’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 12 July 2022 until 30 June 2032.

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, 10 June 2022.

For the Commission

The President

Ursula VON DER LEYEN

(1)  

OJ L 167, 27.6.2012, p. 1

.

(2)  ECHA opinion of 4 March 2021 on the Union authorisation of ‘SOPUROXID’ (ECHA/BPC/279/2021), https://echa.europa.eu/bpc-opinions-on-union-authorisation

ANNEX

Summary of product characteristics for a biocidal product family

SOPUROXID

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-0026179-0000

R4BP asset number: EU-0026179-0000

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 – Disinfection of surfaces in industrial, public and non-medical healthcare areas - manual treatment (mopping)

4.1.1.   

Use-specific instructions for use

Items to be disinfected by mopping have to stay sufficiently wet during the required contact time to allow optimal disinfection.

4.1.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing and loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Re-entry is only permitted once the air concentrations of peracetic acid and hydrogen peroxide have dropped below the respective reference values (AEC). After the application, the room must be ventilated, preferably by mechanical ventilation. The duration of the ventilation period has to be established by measurement with suitable measurement equipment (specified by the authorization holder).

4.1.3.   

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

See general directions for use.

4.1.4.   

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

See general directions for use.

4.1.5.   

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

See general directions for use.

4.2.   

Use description

Table 2

Use # 2 – Disinfection of surfaces in industrial, public and non-medical healthcare areas. - manual treatment (spraying)

4.2.1.   

Use-specific instructions for use

See general directions for use

4.2.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance.

“The treated surface should not be allowed to dry prior to rinsing.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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.

4.3.   

Use description

Table 3

Use # 3 – Clean in Place (CIP) in the pharmaceutical and cosmetic industry

4.3.1.   

Use-specific instructions for use

See general directions for use

4.3.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

Rinse the pump and disconnect it from the installation before maintenance”

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 directions for use.

4.3.4.   

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

See general directions for use.

4.3.5.   

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

See general directions for use.

4.4.   

Use description

Table 4

Use # 4 – Surface disinfection in greenhouses via spraying by user with personal enclosure (in absence of plants - for general hygiene purpose only)

4.4.1.   

Use-specific instructions for use

See general directions for use.

4.4.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

The application should only take place with the user in a personal enclosure and no other person is present.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.4.3.   

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

See general directions for use.

4.4.4.   

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

See general directions for use.

4.4.5.   

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

See general directions for use.

4.5.   

Use description

Table 5

Use # 5 – Surface disinfection in greenhouses via spraying by user without personal enclosure (in absence of plants - for general hygiene purpose only)

4.5.1.   Use-specific instructions for use

See general directions for use.

4.5.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.5.3.   

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

See general directions for use.

4.5.4.   

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

See general directions for use.

4.5.5.   

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

See general directions for use.

4.6.   

Use description

Table 6

Use # 6 – Disinfection of agriculture & horticulture equipment by soaking (in absence of plants - for general hygiene purpose only)

4.6.1.   

Use-specific instructions for use

See general directions for use.

4.6.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

4.6.3.   

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

See general directions for use.

4.6.4.   

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

See general directions for use.

4.6.5.   

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

See general directions for use.

4.7.   

Use description

Table 7

Use # 7 – Disinfection of surfaces and agriculture/horticulture equipment by spraying (in absence of plants - for general hygiene purpose only)

4.7.1.   

Use-specific instructions for use

See general directions for use.

4.7.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

Rinse the pump and disconnect it from the installation before maintenance”

The treated surface should not be allowed to dry prior to rinsing.

4.7.3.   

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

See general directions for use.

4.7.4.   

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

See general directions for use.

4.7.5.   

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

See general directions for use.

4.8.   

Use description

Table 8

Use # 8 – Disinfection of surfaces and agriculture/horticulture equipment by automatic spraying (in absence of plants - for general hygiene purpose only)

4.8.1.   

Use-specific instructions for use

See general directions for use.

4.8.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance”

The treated surface should not be allowed to dry prior to rinsing.

4.8.3.   

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

See general directions for use.

4.8.4.   

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

See general directions for use.

4.8.5.   

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

See general directions for use.

4.9.   

Use description

Table 9

Use # 9 – Disinfection of surfaces and agriculture/horticulture equipment by automatic spraying (closed room) (in absence of plants - for general hygiene purpose only)

4.9.1.   

Use-specific instructions for use

See general directions for use.

4.9.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance”

The treated surface should not be allowed to dry prior to rinsing.

4.9.3.   

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

See general directions for use.

4.9.4.   

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

See general directions for use.

4.9.5.   

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

See general directions for use.

4.10.   

Use description

Table 10

Use # 10 – Disinfection of animal housing – via low-pressure spraying by user with personal enclosure

4.10.1.   

Use-specific instructions for use

It has to be assured that animals are not present when treatment takes place.

4.10.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

The application should only take place with the user in a personal enclosure and no other person is present.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.10.3.   

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

See general directions for use.

4.10.4.   

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

See general directions for use.

4.10.5.   

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

See general directions for use.

4.11.   

Use description

Table 11

Use # 11 – Disinfection of animal housing via low-pressure manual spraying by user without personal enclosure

4.11.1.   

Use-specific instructions for use

It has to be assured that animals are not present when treatment takes place.

4.11.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.11.3.   

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

See general directions for use.

4.11.4.   

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

See general directions for use.

4.11.5.   

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

See general directions for use.

4.12.   

Use description

Table 12

Use # 12 – Disinfection of boots in footbaths in animal housing/husbandries

4.12.1.   

Use-specific instructions for use

See general directions for use.

4.12.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.12.3.   

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.

4.12.4.   

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

See general directions for use.

4.12.5.   

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.

4.13.   

Use description

Table 13

Use # 13 – Disinfection of equipment by dipping

4.13.1.   

Use-specific instructions for use

See general directions for use.

4.13.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance

4.13.3.   

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.

4.13.4.   

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

See general directions for use.

4.13.5.   

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.

4.14.   

Use description

Table 14

Use # 14 – Disinfection in Aseptic Filling Lines (crown corks, cheese moulds and food crates) - Automated spraying closed systems

4.14.1.   

Use-specific instructions for use

See general directions for use.

4.14.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance

The treated surface should not be allowed to dry prior to rinsing.

4.14.3.   

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.

4.14.4.   

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

See general directions for use.

4.14.5.   

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.

4.15.   

Use description

Table 15

Use # 15 – Disinfection of equipment in the food and beverage industry by immersion

4.15.1.   

Use-specific instructions for use

See general directions for use.

4.15.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the post-application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.15.3.   

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.

4.15.4.   

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

See general directions for use.

4.15.5.   

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.

4.16.   

Use description

Table 16

Use # 16 – Disinfection of heat and ion exchangers, membrane filters and glass and PET bottles – CIP procedures

4.16.1.   

Use-specific instructions for use

See general directions for use.

4.16.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

Rinse the pump and disconnect it from the installation before maintenance

4.16.3.   

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.

4.16.4.   

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

See general directions for use.

4.16.5.   

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.

4.17.   Use description

Table 17

Use # 17 – Disinfection of surfaces and equipment by low pressure spraying – spraying with personal enclosure

4.17.1.   

Use-specific instructions for use

See general directions for use.

4.17.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading and application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

The application should only take place with the user in a personal enclosure and no other person is present.

Rinse the pump and disconnect it from the installation before maintenance”

The treated surface should not be allowed to dry prior to rinsing.

4.17.3.   

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.

4.17.4.   

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

See general directions for use.

4.17.5.   

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.

4.18.   

Use description

Table 18

Use # 18 – Disinfection of surfaces and equipment by low pressure spraying – spraying without personal enclosure

4.18.1.   

Use-specific instructions for use

See general directions for use.

4.18.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

Rinse the pump and disconnect it from the installation before maintenance

The treated surface should not be allowed to dry prior to rinsing.

4.18.3.   

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.

4.18.4.   

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

See general directions for use.

4.18.5.   

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.

4.19.   

Use description

Table 19

Use # 19 – Disinfection of surfaces and equipment by low pressure spraying, manually

4.19.1.   

Use-specific instructions for use

See general directions for use.

4.19.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 20 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

Rinse the pump and disconnect it from the installation before maintenance”

The treated surface should not be allowed to dry prior to rinsing.

4.19.3.   

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.

4.19.4.   

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

See general directions for use.

4.19.5.   

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.

4.20.   

Use description

Table 20

Use # 20 – Disinfection of surfaces and equipment by low pressure spraying, automatically

4.20.1.   

Use-specific instructions for use

See general directions for use.

.

4.20.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

RPE are not mandatory during the application phase, on the condition that the operator remains in the control room and do not enter the treated area.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance”

The treated surface should not be allowed to dry prior to rinsing.

4.20.3.   

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.

4.20.4.   

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

See general directions for use.

4.20.5.   

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.

4.21.   

Use description

Table 21

Use # 21 – Disinfection of surfaces and equipment by low pressure spraying – automatic spraying (closed room)

4.21.1.   

Use-specific instructions for use

See general directions for use.

4.21.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) is not mandatory during the application phase, on condition that the operator do not enter the treated area and remains in the control room.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning.

Rinse the pump and disconnect it from the installation before maintenance”

The treated surface should not be allowed to dry prior to rinsing.

4.21.3.   

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.

4.21.4.   

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

See general directions for use.

4.21.5.   

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.

4.22.   

Use description

Table 22

Use # 22 – Disinfection of inner surfaces (pipelines, tanks, vessels, …) by CIP

4.22.1.   

Use-specific instructions for use

See general directions for use.

4.22.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading phase.

Respiratory protection:

Rinse the pump and disconnect it from the installation before maintenance”

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

4.22.3.   

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.

4.22.4.   

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

See general directions for use.

4.22.5.   

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.

4.23.   

Use description

Table 23

Use # 23 – Disinfection of water used for rinsing of recycled items during the washing process

4.23.1.   

Use-specific instructions for use

See general directions for use.

4.23.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection: Not mandatory.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

4.23.3.   

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.

4.23.4.   

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

See general directions for use.

4.23.5.   

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

See general directions for use.

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

5.1.   I

nstructions for use

1.

All the surfaces to be disinfected must be cleaned before the disinfection procedure

2.

Disinfection cycle:

— Products must be diluted in potable water before use.

— Dilution rate & contact time depends on the use considered. Please refer to the description of application method related to each use.

— Final rinsing (with potable water) is mandatory: after the disinfection procedure, treated surfaces are rinsed with water and the water is drained into the sewer system. For exceptions, please refer to the description of application method related to each use.

Only for use in areas that are inaccessible to the general public and companion animals.

No access for the general public during treatment.

Disinfection procedures

by CIP:

 Final rinsing step (with potable water).

After the disinfection procedure, CIP vessels (pipework and tanks) are drained and rinsed with water under closed system conditions

Disinfection procedures

by dipping

: The bath is not intended to be re-used. Use the bath only once a day after work & replace it by a fresh solution daily.

Disinfection procedures

by spraying:

the surfaces to be disinfected must be wet enough in order to keep them wet during the required contact time for optimal disinfection. Then, the user should pay attention to wet surfaces completely with the disinfectant solution.

The Application Rate for spraying of diluted product must be between 20 and 30 mL/m

2

5.2.   

Risk mitigation measures

Dermal protection:

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

A protective coverall which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information).

5.3.   

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

Indirect effects

The two theoretical products are oxidising agents and reactive. In case of thermal decomposition steam and oxygen will be released as decomposition products. The release of oxygen may support combustion.

Also, contact with impurities, decomposition catalysts, metallic salts, alkalis, reducing agents may lead to self-accelerated, exothermic decomposition and the formation of oxygen.

In case of decomposition of the products in confined spaces and pipers, there is a risk of overpressure and burst.

First aid measures

Ø   

General advice

Move out of dangerous area.

Take care of your own personal safety.

Take off immediately all contaminated clothing.

Ø   

Inhalation

Take affected persons out into the fresh air.

Possible discomfort: Irritates skin and mucous linings of the eyes and respiratory tract and cough.

If breathing difficulties occur (e.g. severe continual coughing): Keep patient half sitting with upper body raised; keep warm and in a quiet place; call a physician immediately.

Ø   

Skin contact

After contact with skin, wash immediately with plenty of water.

Consult a physician.

Take off immediately all contaminated clothing.

Immediately rinse contaminated or saturated clothing with water.

Ø   

Eye contact

With eye held open, thoroughly rinse immediately with plenty of water for at least 10 minutes.

Protect unharmed eye.

Continue rinsing process with eye rinsing solution.

Call ambulance (caustic burn of the eyes)

Immediate further treatment in ophthalmic hospital/ophthalmologist.

Continue rinsing eye until arrival at ophthalmic hospital.

Ø   

Ingestion

Do not induce vomiting.

Danger of penetration of the lungs (danger to breathing) when swallowed or vomited, due to gas evolution and foam formation.

Only when patient fully conscious: have the mouth rinsed with water; have the patient drink plenty of water in small sips; keep patient warm and at rest.

Notify ambulance immediately (key word: acid burn).

Ø   

Notes to physician

Therapy as for chemical burn.

Following inhalation:

Formation of a toxic lung oedema is possible if product continues to be inhaled despite acute irritative effect (e.g. if it is not possible to leave the danger area).

Prophylaxis of a toxic lung oedema with inhalative steroids (dosing spray, e.g. auxilosone).

If substance has been swallowed:

Aspiration hazard.

Risk of gaseous embolisms.

In case of excessive strain on the stomach due to gas evolution, insert siphon tube.

Early endoscopy in order to assess mucosa lesions in the oesophagus and stomach which may appear.

If necessary, suck away leftover substance.

Do not administer activated charcoal, since risk of release of large amounts of gas from hydrogen peroxide.

Emergency measures to protect the environment

Observe regulations on prevention of water pollution (collect, dam up, cover up).

Do not allow to run into water channels, surface water or into the ground.

Ø   

Methods for cleaning up

Clean contaminated surface thoroughly; recommended cleaning agent is water.

In case of small spills, dilute product with lots of water and rinse away or absorb product with liquid-binding material, e.g. chemi-sorption, diatomaceous earth, universal binder. Do not use textiles, saw dust, combustible substances. After binding, pick up mechanically and collect in suitable containers. Dispose of absorbed material in accordance with the regulations.

Ø   

Additional advice

Make safe or remove all sources of ignition.

Isolate defective containers immediately, if possible and safe to do.

Shut off leak, if possible and safe to do.

Place defective containers in waste receptacle (waste packaging receptacle) made of plastic (not metal).

Do not seal defective containers or waste receptacles airtight (danger of bursting due to product decomposition).

Product taken out should not be returned into container.

Never return spilled product into its original container for re-use (risk of decomposition).

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 only in the original packaging tightly closed in a cool and well-ventilated place Keep products away from direct sunlight, source of heat and ignition

The shelf life of the biocidal product is 6 months.

The products must be stored at temperatures below + 30 °C.

6.   OTHER INFORMATION

Reference values of peracetic acid and hydrogen peroxide used for the risk assessment:

PAA

: AECinhal = 0,5 mg/m

3

HP

: AECinhal = 1,25 mg/m

3

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 1

7.1.   

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

7.2.   

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

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   

Meta SPC 2 identifier

1.2.   

Suffix to the authorisation number

1.3.   

Product type(s)

2.   META SPC 2 COMPOSITION

2.1.   

Qualitative and quantitative information on the composition of the meta SPC 2

2.2.   

Type(s) of formulation of the meta SPC 2

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

4.   AUTHORISED USE(S) OF THE META SPC 2

4.1.   

Use description

Table 24

Use # 1 – Room Disinfection by fogging - In industrial, public and non-medical healthcare areas. (pharmaceutical and cosmetic industry)

4.1.1.   

Use-specific instructions for use

See general directions for use.

4.1.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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 25

Use # 2 – Room Disinfection by fogging - In agriculture & horticulture areas (in absence of plants - for general hygiene purpose only)

4.2.1.   

Use-specific instructions for use

See general directions for use.

4.2.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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.

4.3.   

Use description

Table 26

Use # 3 – Room Disinfection by fogging – In animal housing

4.3.1.   

Use-specific instructions for use

See general directions for use.

4.3.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance.

Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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 directions for use.

4.3.4.   

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

See general directions for use.

4.3.5.   

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

See general directions for use.

4.4.   

Use description

Table 27

Use # 4 – Room Disinfection by fogging – In storage rooms with special device in storage cellar or room

4.4.1.   

Use-specific instructions for use

See general directions for use.

4.4.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.4.3.   

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

See general directions for use.

4.4.4.   

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

See general directions for use.

4.4.5.   

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

See general directions for use.

5.   GENERAL DIRECTIONS FOR USE (2) OF THE META SPC 2

5.1.   

Instructions for use

1.

All the surfaces to be disinfected must be cleaned before the disinfection procedure.

For exceptions, please refer to the description of application method related to each use.

2.

Disinfection cycle:

— Products must be diluted in potable water before use.

— Dilution rate & contact time depends on the use considered. Please refer to the description of application method related to each use.

— Final rinsing (with potable water) is mandatory: after the disinfection procedure, treated surfaces are rinsed with water and the water is drained into the sewer system. For exceptions, please refer to the description of application method related to each use.

Meta SPC2: Disinfection procedures by fogging

The product SOPUROXID 3.2 is a liquid disinfectant to be applied (after dilution at 40 %) by fogging for airborne surface disinfection and to be used indoor by professional users only.

Always check compatibility of the products with the hard/non-porous surfaces to be disinfected.

The product SOPUROXID 3.2 has been developed and demonstrated as efficacious (via efficacy studies performed according to the NF T 72 281 standard), using one device HYSPRAY, for rooms with a volume between 30 & 150 m

3

 (volume per application and per device) with a flow rate of 0,047 mL/min/m

3

.

The use of other devices is possible. They must be designed to work with PAA-based products and to ensure a fog production able to stay suspended in the air and provided that these devices meet following characteristics:

1)

Particle (medium droplet) size: between 1 and 15 μm

2)

Flow rate: 0,047 mL/min/m

3

3)

Application rate: 5,6 mL/m

3

4)

Room volume between 30 and 150 m

3

per application and per device (i.e. diffusion time between 5 and 30 min)

— Airborne disinfection should be done only after thorough cleaning and rinsing.

The surfaces to be disinfected should be dried before the disinfection procedure. Please pay attention to open the cupboard doors. Please check the temperature and the relative room humidity (to be set between 40 and 80 %) to obtain an optimal level for the product efficiency.

— The room where the fogging activity takes place is tightly sealed during fogging, no user is present:

Before the start of the disinfection cycle by fogging, the treated room is sealed. All the safety tasks for the implementation of decontamination are entrusted to an user who has completed the necessary training. Among them, first step is shutting down the air handling units and closing the air intake and return, so the product is not spread in the other rooms. The door or doors to the outside of the area are then locked and, if the joints are not tight enough, they are taped to seal. An orange tape, or bright colour, is preferably chosen to attract attention and a sign "Access ban, room disinfection in progress" is put on. Only for use in areas that are inaccessible to the general public and companion animals”.

— The user shall always carry out a microbiological validation of the disinfection in the rooms to be disinfected (or in a suitable "standard room", if applicable) with the devices to be used, after which a protocol for disinfection of these rooms can be made and used thereafter. Each device or specific installation is systematically validated when it is set up.

5.2.   

Risk mitigation measures

Dermal protection:

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

A protective coverall which is impermeable for the biocidal product shall be worn (coverall material to be specified by the authorisation holder within the product information).

+ Additional specific RMM for

fogging

applications:

 

Only for use in areas that are inaccessible to the general public and companion animals.

— After disinfection product’s application by fogging & required contact time for optimal disinfection (2h), the room must be ventilated, preferably by mechanical ventilation at least for 60 min.

The duration of the ventilation period has to be established by measurement with suitable measurement equipment (specified by the authorisation holder within the product information).

— After ventilation, re-entry in the disinfected area is only permitted after the air concentrations of peracetic acid and hydrogen peroxide have been checked and seen as dropped below the respective reference values (AEC):

— The air concentration of PAA must have dropped to 0,5 mg/m

3

.

5.3.   

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

Indirect effects

The two products are oxidising agents and reactive. In case of thermal decomposition steam and oxygen will be released as decomposition products. The release of oxygen may support combustion.

Also, contact with impurities, decomposition catalysts, metallic salts, alkalis, reducing agents may lead to self-accelerated, exothermic decomposition and the formation of oxygen.

In case of decomposition of the products in confined spaces and pipers, there is a risk of overpressure and burst.

First aid measures

Ø   

General advice

Move out of dangerous area.

Take care of your own personal safety.

Take off immediately all contaminated clothing.

Ø   

Inhalation

Take affected persons out into the fresh air.

Possible discomfort: Irritates skin and mucous linings of the eyes and respiratory tract and cough.

If breathing difficulties occur (e.g. severe continual coughing): Keep patient half sitting with upper body raised; keep warm and in a quiet place; call a physician immediately.

Ø   

Skin contact

After contact with skin, wash immediately with plenty of water.

Consult a physician.

Take off immediately all contaminated clothing.

Immediately rinse contaminated or saturated clothing with water.

Ø   

Eye contact

With eye held open, thoroughly rinse immediately with plenty of water for at least 10 minutes.

Protect unharmed eye.

Continue rinsing process with eye rinsing solution.

Call ambulance (caustic burn of the eyes)

Immediate further treatment in ophthalmic hospital/ophthalmologist.

Continue rinsing eye until arrival at ophthalmic hospital.

Ø   

Ingestion

Do not induce vomiting.

Danger of penetration of the lungs (danger to breathing) when swallowed or vomited, due to gas evolution and foam formation.

Only when patient fully conscious: have the mouth rinsed with water; have the patient drink plenty of water in small sips; keep patient warm and at rest.

Notify ambulance immediately (key word: acid burn).

Ø   

Notes to physician

Therapy as for chemical burn.

Following inhalation:

Formation of a toxic lung oedema is possible if product continues to be inhaled despite acute irritative effect (e.g. if it is not possible to leave the danger area).

Prophylaxis of a toxic lung oedema with inhalative steroids (dosing spray, e.g. auxilosone).

If substance has been swallowed:

Aspiration hazard.

Risk of gaseous embolisms.

In case of excessive strain on the stomach due to gas evolution, insert siphon tube.

Early endoscopy in order to assess mucosa lesions in the oesophagus and stomach which may appear.

If necessary, suck away leftover substance.

Do not administer activated charcoal, since risk of release of large amounts of gas from hydrogen peroxide.

Emergency measures to protect the environment

Observe regulations on prevention of water pollution (collect, dam up, cover up).

Do not allow to run into water channels, surface water or into the ground.

Ø   

Methods for cleaning up

Clean contaminated surface thoroughly; recommended cleaning agent is water.

In case of small spills, dilute product with lots of water and rinse away or absorb product with liquid-binding material, e.g. chemi-sorption, diatomaceous earth, universal binder. Do not use textiles, saw dust, combustible substances. After binding, pick up mechanically and collect in suitable containers. Dispose of absorbed material in accordance with the regulations.

Ø   

Additional advice

Make safe or remove all sources of ignition.

Isolate defective containers immediately, if possible and safe to do.

Shut off leak, if possible and safe to do.

Place defective containers in waste receptacle (waste packaging receptacle) made of plastic (not metal).

Do not seal defective containers or waste receptacles airtight (danger of bursting due to product decomposition).

Product taken out should not be returned into container.

Never return spilled product into its original container for re-use (risk of decomposition).

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 only in the original packaging tightly closed in a cool and well-ventilated place Keep products away from direct sunlight, source of heat and ignition

The shelf life of the biocidal product is 6 months.

The products must be stored at temperatures below + 30 °C.

6.   OTHER INFORMATION

Reference values of peracetic acid and hydrogen peroxide used for the risk assessment:

PAA

: AECinhal = 0,5 mg/m

3

HP

: AECinhal = 1,25 mg/m

3

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

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 28

Use # 1 – Disinfection of surfaces in industrial, public and non-medical healthcare areas. – foam application on surfaces

4.1.1.   

Use-specific instructions for use

See general directions for use.

4.1.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 10 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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 29

Use # 2 – Disinfection of surfaces and agriculture/horticulture equipment by foaming, manually (in absence of plants - for general hygiene purpose only)

4.2.1.   

Use-specific instructions for use

See general directions for use.

4.2.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

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.

4.3.   

Use description

Table 30

Use # 3 – Disinfection of surfaces and agriculture/horticulture equipment by automatic foaming (in absence of plants - for general hygiene purpose only)

4.3.1.   

Use-specific instructions for use

See general directions for use.

4.3.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

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 directions for use.

4.3.4.   

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

See general directions for use.

4.3.5.   

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

See general directions for use.

4.4.   

Use description

Table 31

Use # 4 – Disinfection of surfaces and agriculture/horticulture equipment by automatic foaming (closed rooms) (in absence of plants - for general hygiene purpose only)

4.4.1.   

Use-specific instructions for use

See general directions for use.

4.4.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing & loading.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

The application is automatic and should only take place when no one is present in the treated area.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

4.4.3.   

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

See general directions for use.

4.4.4.   

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

See general directions for use.

4.4.5.   

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

See general directions for use.

4.5.   

Use description

Table 32

Use # 5 – Disinfection of animal houses by foaming – foaming with personal enclosure

4.5.1.   

Use-specific instructions for use

It has to be assured that animals are not present when treatment takes place.

4.5.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading and of a factor of 10 during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken

The application should only take place with the user in a personal enclosure and no other person is present.

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.5.3.   

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

See general directions for use.

4.5.4.   

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

See general directions for use.

4.5.5.   

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

See general directions for use.

4.6.   

Use description

Table 33

Use # 6 – Disinfection of animal houses by foaming – foaming without personal enclosure

4.6.1.   

Use-specific instructions for use

It has to be assured that animals are not present when treatment takes place.

4.6.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

Use of respiratory protective equipment (RPE) providing a protection factor of 40 is mandatory during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning

Rinse the pump and disconnect it from the installation before maintenance”

“The treated surface should not be allowed to dry prior to rinsing”.

Only treatment of empty animal housings. Re-entry of animals only after adequate ventilation and when surfaces are dried.

Re-entry of the general public only when surfaces are dried and after sufficient ventilation.

4.6.3.   

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

See general directions for use.

4.6.4.   

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

See general directions for use.

4.6.5.   

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

See general directions for use.

4.7.   

Use description

Table 34

Use # 7 – Disinfection of surfaces by foaming – foaming with personal enclosure

4.7.1.   

Use-specific instructions for use

See general directions for use.

4.7.2.   

Use-specific risk mitigation measures

Dermal protection:

Use appropriate safety glasses and/or face shield during the mixing, loading & application phase.

Respiratory protection:

Use of respiratory protective equipment (RPE) providing a protection factor of 4 is mandatory during mixing and loading.

Respiratory protection with an APF of 10 is required during the application phase.

When the product is being used in areas accessible to the public, mark treated areas during the treatment period and indicate possible risks for humans and non-target organisms (e.g. primary and secondary poisoning) as well as first measures to be taken in case of poisoning