# Official Journal L 225/2023

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 225 |
| | |
| English edition | Legislation | Volume 6613 September 2023 |

ISSN 1977-0677

Official Journal

of the European Union

L 225

English edition

Legislation

Volume 6613 September 2023

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2023/1761 of 6 September 2023 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (Mela Alto Adige / Südtiroler Apfel (PGI)) | 1 |
| | * | Commission Implementing Regulation (EU) 2023/1762 of 6 September 2023 registering a geographical indication of a spirit drink under Article 30(2) of Regulation (EU) 2019/787 of the European Parliament and of the Council (Sárréti kökénypálinka) | 3 |
| | * | Commission Implementing Regulation (EU) 2023/1763 of 12 September 2023 granting a Union authorisation for the biocidal product family Lactic acid Family – Quatchem in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  ) | 5 |
| | * | Commission Implementing Regulation (EU) 2023/1764 of 12 September 2023 granting a Union authorisation for the biocidal product family Oxy’Pharm H2O2 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  ) | 21 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2023/1761 of 6 September 2023 approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (Mela Alto Adige / Südtiroler Apfel (PGI))

1

*

Commission Implementing Regulation (EU) 2023/1762 of 6 September 2023 registering a geographical indication of a spirit drink under Article 30(2) of Regulation (EU) 2019/787 of the European Parliament and of the Council (Sárréti kökénypálinka)

3

*

Commission Implementing Regulation (EU) 2023/1763 of 12 September 2023 granting a Union authorisation for the biocidal product family Lactic acid Family – Quatchem in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  )

1

5

*

Commission Implementing Regulation (EU) 2023/1764 of 12 September 2023 granting a Union authorisation for the biocidal product family Oxy’Pharm H2O2 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  )

2

2

1

21

| | |
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| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
| --- | --- |

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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II Non-legislative acts

REGULATIONS

| 13.9.2023 | EN | Official Journal of the European Union | L 225/1 |
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13.9.2023

EN

Official Journal of the European Union

L 225/1

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/1761

of 6 September 2023

approving non-minor amendments to the specification for a name entered in the register of protected designations of origin and protected geographical indications (‘Mela Alto Adige / Südtiroler Apfel’ (PGI))

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (1), and in particular Article 52(2) thereof,

Whereas:

| (1) | Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Italy’s application for the approval of amendments to the specification for the protected geographical indication ‘Mela Alto Adige / Südtiroler Apfel’ registered under Commission Regulation (EC) No 1855/2005 (2). |
| --- | --- |

(1)

Pursuant to the first subparagraph of Article 53(1) of Regulation (EU) No 1151/2012, the Commission has examined Italy’s application for the approval of amendments to the specification for the protected geographical indication ‘Mela Alto Adige / Südtiroler Apfel’ registered under Commission Regulation (EC) No 1855/2005 (2).

| (2) | Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union as required by Article 50(2)(a) of that Regulation (3). |
| --- | --- |

(2)

Since the amendments in question are not minor within the meaning of Article 53(2) of Regulation (EU) No 1151/2012, the Commission published the amendment application in the Official Journal of the European Union as required by Article 50(2)(a) of that Regulation (3).

| (3) | As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the product specification should be approved, |
| --- | --- |

(3)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the amendments to the product specification should be approved,

HAS ADOPTED THIS REGULATION:

Article 1

The amendments to the specification published in the Official Journal of the European Union regarding the name ‘Mela Alto Adige / Südtiroler Apfel’ (PGI) are hereby approved.

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, 6 September 2023.

For the Commission,

On behalf of the President,

Janusz WOJCIECHOWSKI

Member of the Commission

---

(1)  
  OJ L 343, 14.12.2012, p. 1.

1

(2)  Commission Regulation (EC) No 1855/2005 of 14 November 2005 supplementing the Annex to Regulation (EC) No 2400/96 as regards the entry of certain names in the Register of protected designations of origin and protected geographical indications (Mela Alto Adige or Südtiroler Apfel (PGI), Asperge des Sables des Landes (PGI), Pâtes d’Alsace (PGI), Jamón de Trevélez (PGI), Oliva Ascolana del Piceno (PDO)) (OJ L 297, 15.11.2005, p. 5).

2

(3)  
  OJ C 182, 24.5.2023, p. 20.

3

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| 13.9.2023 | EN | Official Journal of the European Union | L 225/3 |
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13.9.2023

EN

Official Journal of the European Union

L 225/3

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/1762

of 6 September 2023

registering a geographical indication of a spirit drink under Article 30(2) of Regulation (EU) 2019/787 of the European Parliament and of the Council (‘Sárréti kökénypálinka’)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) 2019/787 of the European Parliament and of the Council of 17 April 2019 on the definition, description, presentation and labelling of spirit drinks, the use of the names of spirit drinks in the presentation and labelling of other foodstuffs, the protection of geographical indications for spirit drinks, the use of ethyl alcohol and distillates of agricultural origin in alcoholic beverages, and repealing Regulation (EC) No 110/2008 (1), and in particular Article 30(2) thereof,

Whereas:

| (1) | Pursuant to Article 17(5) of Regulation (EC) No 110/2008 of the European Parliament and of the Council (2), the Commission has examined Hungary’s application of 6 March 2019 for the registration of the name ‘Sárréti kökénypálinka’ as a geographical indication. |
| --- | --- |

(1)

Pursuant to Article 17(5) of Regulation (EC) No 110/2008 of the European Parliament and of the Council (2), the Commission has examined Hungary’s application of 6 March 2019 for the registration of the name ‘Sárréti kökénypálinka’ as a geographical indication.

| (2) | Regulation (EU) 2019/787, which replaces Regulation (EC) No 110/2008, entered into force on 25 May 2019. Under Article 49(1) thereof, Chapter III of Regulation (EC) No 110/2008 on geographical indications is repealed with effect from 8 June 2019. |
| --- | --- |

(2)

Regulation (EU) 2019/787, which replaces Regulation (EC) No 110/2008, entered into force on 25 May 2019. Under Article 49(1) thereof, Chapter III of Regulation (EC) No 110/2008 on geographical indications is repealed with effect from 8 June 2019.

| (3) | After concluding that the application complied with Regulation (EC) No 110/2008, the Commission published the main specifications of the technical file in the Official Journal of the European Union (3) as required by Article 17(6) of that Regulation, in accordance with the first subparagraph of Article 50(4) of Regulation (EU) 2019/787. |
| --- | --- |

(3)

After concluding that the application complied with Regulation (EC) No 110/2008, the Commission published the main specifications of the technical file in the Official Journal of the European Union (3) as required by Article 17(6) of that Regulation, in accordance with the first subparagraph of Article 50(4) of Regulation (EU) 2019/787.

| (4) | No notice of opposition has been received by the Commission under Article 27(1) of Regulation (EU) 2019/787. |
| --- | --- |

(4)

No notice of opposition has been received by the Commission under Article 27(1) of Regulation (EU) 2019/787.

| (5) | The name ‘Sárréti kökénypálinka’ should therefore be registered as a geographical indication, |
| --- | --- |

(5)

The name ‘Sárréti kökénypálinka’ should therefore be registered as a geographical indication,

HAS ADOPTED THIS REGULATION:

Article 1

The geographical indication ‘Sárréti kökénypálinka’ is hereby entered in the register. This Regulation grants the geographical indication ‘Sárréti kökénypálinka’ the protection referred to in Article 21 of Regulation (EU) 2019/787 in accordance with Article 30(4) of that Regulation.

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, 6 September 2023.

For the Commission,

On behalf of the President,

Janusz WOJCIECHOWSKI

Member of the Commission

---

(1)  
  OJ L 130, 17.5.2019, p. 1.

1

(2)  Regulation (EC) No 110/2008 of the European Parliament and of the Council of 15 January 2008 on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks and repealing Council Regulation (EEC) No 1576/89 (OJ L 39, 13.2.2008, p. 16).

2

(3)  
  OJ C 182, 24.5.2023, p. 20.

3

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| 13.9.2023 | EN | Official Journal of the European Union | L 225/5 |
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13.9.2023

EN

Official Journal of the European Union

L 225/5

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COMMISSION IMPLEMENTING REGULATION (EU) 2023/1763

of 12 September 2023

granting a Union authorisation for the biocidal product family ‘Lactic acid Family – Quatchem’ in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular Article 44(5), first subparagraph, thereof,

Whereas:

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

(1)

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

| (2) | ‘Lactic acid Family – Quatchem’ contains L-(+)-lactic acid as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 3. |
| --- | --- |

(2)

‘Lactic acid Family – Quatchem’ contains L-(+)-lactic acid as the active substance, included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-type 3.

| (3) | On 16 May 2022, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency. |
| --- | --- |

(3)

On 16 May 2022, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

| (4) | On 13 December 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Lactic acid Family – Quatchem’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012. |
| --- | --- |

(4)

On 13 December 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Lactic acid Family – Quatchem’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012.

| (5) | The opinion concludes that ‘Lactic acid Family – Quatchem’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. |
| --- | --- |

(5)

The opinion concludes that ‘Lactic acid Family – Quatchem’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

| (6) | On 5 January 2023, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(6)

On 5 January 2023, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

| (7) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Lactic acid Family – Quatchem’. |
| --- | --- |

(7)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Lactic acid Family – Quatchem’.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

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

The Union authorisation is valid from 3 October 2023 to 30 September 2033.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 12 September 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 167, 27.6.2012, p. 1.

1

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

2

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ANNEX

Summary of product characteristics for a biocidal product family

Lactic acid Family - Quatchem

Product type 3 - Veterinary hygiene (Disinfectants)

Authorisation number: EU-0030143-0000

R4BP asset number: EU-0030143-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

| Name | Lactic acid Family - Quatchem |
| --- | --- |

Name

Lactic acid Family - Quatchem

1.2.   Product type(s)

| Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |

Product type(s)

PT03 - Veterinary hygiene (Disinfectants)

1.3.   Authorisation holder

| Name and address of the authorisation holder | Name | Arrow Regulatory (Ireland) Limited |
| --- | --- | --- |
| Address | The Black Church St. Mary's Place, D07 P4AX Dublin Ireland |
| Authorisation number | EU-0030143-0000 |
| R4BP asset number | EU-0030143-0000 |
| Date of the authorisation | 3 October 2023 |
| Expiry date of the authorisation | 30 September 2033 |

Name and address of the authorisation holder

Name

Arrow Regulatory (Ireland) Limited

Address

The Black Church St. Mary's Place, D07 P4AX Dublin Ireland

Authorisation number

EU-0030143-0000

R4BP asset number

EU-0030143-0000

Date of the authorisation

3 October 2023

Expiry date of the authorisation

30 September 2033

1.4.   Manufacturer(s) of the biocidal products

| Name of manufacturer | Quat-Chem Ltd. A Neogen Company |
| --- | --- |
| Address of manufacturer | 1-4 Sandfield Industrial Park, Dodgson Street, Rochdale, OL16 5SJ Lancashire United Kingdom |
| Location of manufacturing sites | 1-4 Sandfield Industrial Park, Dodgson Street, Rochdale, OL16 5SJ Lancashire United Kingdom |

Name of manufacturer

Quat-Chem Ltd. A Neogen Company

Address of manufacturer

1-4 Sandfield Industrial Park, Dodgson Street, Rochdale, OL16 5SJ Lancashire United Kingdom

Location of manufacturing sites

1-4 Sandfield Industrial Park, Dodgson Street, Rochdale, OL16 5SJ Lancashire United Kingdom

1.5.   Manufacturer(s) of the active substance(s)

| Active substance | L-(+)-lactic acid |
| --- | --- |
| Name of manufacturer | Purac Biochem bv |
| Address of manufacturer | Arkelsedijk 46, 4206 AC Gorinchem Netherlands |
| Location of manufacturing sites | Arkelsedijk 46, 4206 AC Gorinchem Netherlands |

Active substance

L-(+)-lactic acid

Name of manufacturer

Purac Biochem bv

Address of manufacturer

Arkelsedijk 46, 4206 AC Gorinchem Netherlands

Location of manufacturing sites

Arkelsedijk 46, 4206 AC Gorinchem Netherlands

| Active substance | L-(+)-lactic acid |
| --- | --- |
| Name of manufacturer | Jungbunzlauer S. A |
| Address of manufacturer | Z.I. et Portuaire, B.P. 32, FR-67390 Marckolsheim France |
| Location of manufacturing sites | Z.I. et Portuaire, B.P. 32, FR-67390 Marckolsheim France |

Active substance

L-(+)-lactic acid

Name of manufacturer

Jungbunzlauer S. A

Address of manufacturer

Z.I. et Portuaire, B.P. 32, FR-67390 Marckolsheim France

Location of manufacturing sites

Z.I. et Portuaire, B.P. 32, FR-67390 Marckolsheim France

2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 4,0 | 4,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

4,0

4,0

2.2.   Type(s) of formulation

| Formulation(s) | AL - Any other liquid |
| --- | --- |

Formulation(s)

AL - Any other liquid

PART II

SECOND INFORMATION LEVEL - META SPC(S)

META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

| Identifier | meta SPC 1 |
| --- | --- |

Identifier

meta SPC 1

1.2.   Suffix to the authorisation number

| Number | 1-1 |
| --- | --- |

Number

1-1

1.3.   Product type(s)

| Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |

Product type(s)

PT03 - Veterinary hygiene (Disinfectants)

2.   META SPC 1 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 4,0 | 4,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

4,0

4,0

2.2.   Type(s) of formulation of the meta SPC 1

| Formulation(s) | AL - Any other liquid |
| --- | --- |

Formulation(s)

AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

| Hazard statements | Causes skin irritation.
  Causes serious eye damage. |
| --- | --- |
| Precautionary statements | Wear protective gloves.
  Wear eye protection.
  Wash hands thoroughly after handling.
  IF IN EYES:Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a doctor.
  IF ON SKIN:Wash with plenty of water.
  If skin irritation occurs: Get medical advice.
  If skin irritation occurs: Get medical attention.
  Take off contaminated clothing. And wash it before reuse.
  Dispose of contents to hazardous or special waste collection point in accordance with national regulations.
  Dispose of container to hazardous or special waste collection point in accordance with national regulations. |

Hazard statements

Causes skin irritation.

Causes serious eye damage.

Precautionary statements

Wear protective gloves.

Wear eye protection.

Wash hands thoroughly after handling.

IF IN EYES:Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a doctor.

IF ON SKIN:Wash with plenty of water.

If skin irritation occurs: Get medical advice.

If skin irritation occurs: Get medical attention.

Take off contaminated clothing. And wash it before reuse.

Dispose of contents to hazardous or special waste collection point in accordance with national regulations.

Dispose of container to hazardous or special waste collection point in accordance with national regulations.

4.   AUTHORISED USE(S) OF THE META SPC 1

4.1.   Use description

Table 1.

Use # 1 – Use # 1.1 – Post milking teat disinfection – manual dipping

| Product type | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: Bacteria
  Development stage: -
  Scientific name: Yeasts
  Common name: Yeasts
  Development stage: - |
| Field(s) of use | Indoor
  Teat disinfection post-milking by manual dipping using a dip cup |
| Application method(s) | Method: Manual dipping using a dip cup
  Detailed description:
  Contact time for dipping at 30 oC in dirty conditions:
  - 5 minutes for bacteria and yeasts. |
| Application rate(s) and frequency | Application Rate: 5 to 10 ml per teat
  Dilution (%): RTU (Ready-to-use) product
  Number and timing of application:
  up to twice per day |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | | 1 000 litre high density polyethylene (HDPE) container with HDPE closure; |

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: Bacteria

Development stage: -

Scientific name: Yeasts

Common name: Yeasts

Development stage: -

Field(s) of use

Indoor

Teat disinfection post-milking by manual dipping using a dip cup

Application method(s)

Method: Manual dipping using a dip cup

Detailed description:

Contact time for dipping at 30 oC in dirty conditions:

- 5 minutes for bacteria and yeasts.

Application rate(s) and frequency

Application Rate: 5 to 10 ml per teat

Dilution (%): RTU (Ready-to-use) product

Number and timing of application:

up to twice per day

Category(ies) of users

Professional

Pack sizes and packaging material

1 000 litre high density polyethylene (HDPE) container with HDPE closure;

| | 200 litre plastic drum with HDPE closure; |
| --- | --- |

200 litre plastic drum with HDPE closure;

| | 25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap; |
| --- | --- |

25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap;

| | 5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap. |
| --- | --- |

5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap.

4.1.1.   Use-specific instructions for use

See general directions for use.

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

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

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.2.   Use description

Table 2.

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

| Product type | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | | Scientific name: Bacteria |

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

| | Common name: Bacteria |
| --- | --- |

Common name: Bacteria

| | Development stage: - |
| --- | --- |

Development stage: -

| | Scientific name: Yeasts |
| --- | --- |

Scientific name: Yeasts

| | Common name: Yeasts |
| --- | --- |

Common name: Yeasts

| | Development stage: - |
| --- | --- |

Development stage: -

Field(s) of use

Indoor

Teat disinfection post-milking by using hand-held sprayer

Application method(s)

Method: Manual spraying using hand-held sprayer

Detailed description:

Contact time for spraying at 30 oC in dirty conditions:

| — | 5 minutes for bacteria and yeasts. |
| --- | --- |

—

5 minutes for bacteria and yeasts.

Application rate(s) and frequency

Application Rate: 5 to 10 ml per teat

Dilution (%): RTU product

Number and timing of application:

up to twice per day

Category(ies) of users

Professional

Pack sizes and packaging material

| | 1 000 litre HDPE container with HDPE closure; |
| --- | --- |

1 000 litre HDPE container with HDPE closure;

| | 200 litre plastic drum with HDPE closure; |
| --- | --- |

200 litre plastic drum with HDPE closure;

| | 25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap; |
| --- | --- |

25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap;

| | 5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap. |
| --- | --- |

5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap.

4.2.1.   Use-specific instructions for use

See general directions for use.

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

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

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

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

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

5.1.   Instructions for use

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

Always read the label or leaflet before use.

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

5.2.   Risk mitigation measures

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

Avoid hand to eye transfer.

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

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

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

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

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

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

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

5.4.   Instructions for safe disposal of the product and its packaging

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

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

| | Keep out of reach of children. |
| --- | --- |

Keep out of reach of children.

| | Store in original container tightly closed. |
| --- | --- |

Store in original container tightly closed.

| | Store between 0 °C and + 30 °C. |
| --- | --- |

Store between 0 °C and + 30 °C.

| | Shelf life: 24 months |
| --- | --- |

Shelf life: 24 months

6.   OTHER INFORMATION

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

| | EN ISO 16321 - Eye and face protection for occupational use |
| --- | --- |

EN ISO 16321 - Eye and face protection for occupational use

| | EN ISO 374 – Protective gloves against dangerous chemicals and microorganisms |
| --- | --- |

EN ISO 374 – Protective gloves against dangerous chemicals and microorganisms

| | EN 455 - Medical gloves for single use |
| --- | --- |

EN 455 - Medical gloves for single use

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

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

| Trade name(s) | Synodex | Market area: EU |
| --- | --- | --- |
| | Lactopost | Market area: EU |
| Lactopost Y | Market area: EU |
| Lactopost Plus | Market area: EU |
| Lactopost Extra | Market area: EU |
| Synodex Y | Market area: EU |
| Synodex Extra | Market area: EU |
| Synodex Plus | Market area: EU |
| Udder X | Market area: EU |
| Teat Care | Market area: EU |
| Lacto Gold | Market area: EU |
| Lacto Extra | Market area: EU |
| Lactogold | Market area: EU |
| Lacto Spray | Market area: EU |
| Authorisation number | EU-0030143-0001 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 4,0 |

Trade name(s)

Synodex

Market area: EU

Lactopost

Market area: EU

Lactopost Y

Market area: EU

Lactopost Plus

Market area: EU

Lactopost Extra

Market area: EU

Synodex Y

Market area: EU

Synodex Extra

Market area: EU

Synodex Plus

Market area: EU

Udder X

Market area: EU

Teat Care

Market area: EU

Lacto Gold

Market area: EU

Lacto Extra

Market area: EU

Lactogold

Market area: EU

Lacto Spray

Market area: EU

Authorisation number

EU-0030143-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

4,0

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

| Trade name(s) | Laxsan | Market area: EU |
| --- | --- | --- |
| | Hexsan | Market area: EU |
| Lactopost R | Market area: EU |
| Laxsan R | Market area: EU |
| Hexfoam | Market area: EU |
| Deosan LA1 | Market area: EU |
| Hexsan Extra | Market area: EU |
| Hexsan Plus | Market area: EU |
| Laxsan Plus | Market area: EU |
| Laxsan Extra | Market area: EU |
| Hexsan R | Market area: EU |
| LA1 | Market area: EU |
| Condition Pink | Market area: EU |
| Authorisation number | EU-0030143-0002 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 4,0 |

Trade name(s)

Laxsan

Market area: EU

Hexsan

Market area: EU

Lactopost R

Market area: EU

Laxsan R

Market area: EU

Hexfoam

Market area: EU

Deosan LA1

Market area: EU

Hexsan Extra

Market area: EU

Hexsan Plus

Market area: EU

Laxsan Plus

Market area: EU

Laxsan Extra

Market area: EU

Hexsan R

Market area: EU

LA1

Market area: EU

Condition Pink

Market area: EU

Authorisation number

EU-0030143-0002 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

4,0

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

| Identifier | meta SPC 2 |
| --- | --- |

Identifier

meta SPC 2

1.2.   Suffix to the authorisation number

| Number | 1-2 |
| --- | --- |

Number

1-2

1.3.   Product type(s)

| Product type(s) | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |

Product type(s)

PT03 - Veterinary hygiene (Disinfectants)

2.   META SPC 2 COMPOSITION

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

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 4,0 | 4,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

4,0

4,0

2.2.   Type(s) of formulation of the meta SPC 2

| Formulation(s) | AL - Any other liquid |
| --- | --- |

Formulation(s)

AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

| Hazard statements | Causes skin irritation.
  Causes serious eye damage.
  Contains peppermint oil. May produce an allergic reaction. |
| --- | --- |
| Precautionary statements | Wear protective gloves.
  Wear eye protection.
  Wash hands thoroughly after handling.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a doctor.
  IF ON SKIN:Wash with plenty of water.
  If skin irritation occurs:Get medical advice.
  If skin irritation occurs:Get medical attention.
  Take off contaminated clothing.And wash it before reuse.
  Dispose of contents to hazardous or special waste collection point in accordance with national regulations.
  Dispose of container to hazardous or special waste collection point in accordance with national regulations. |

Hazard statements

Causes skin irritation.

Causes serious eye damage.

Contains peppermint oil. May produce an allergic reaction.

Precautionary statements

Wear protective gloves.

Wear eye protection.

Wash hands thoroughly after handling.

IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a doctor.

IF ON SKIN:Wash with plenty of water.

If skin irritation occurs:Get medical advice.

If skin irritation occurs:Get medical attention.

Take off contaminated clothing.And wash it before reuse.

Dispose of contents to hazardous or special waste collection point in accordance with national regulations.

Dispose of container to hazardous or special waste collection point in accordance with national regulations.

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

4.1.   Use description

Table 3.

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

| Product type | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | | Scientific name: Bacteria |

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

| | Common name: Bacteria |
| --- | --- |

Common name: Bacteria

| | Development stage: - |
| --- | --- |

Development stage: -

| | Scientific name: Yeasts |
| --- | --- |

Scientific name: Yeasts

| | Common name: Yeasts |
| --- | --- |

Common name: Yeasts

| | Development stage: - |
| --- | --- |

Development stage: -

Field(s) of use

Indoor

Teat disinfection post-milking by manual dipping using a dip cup

Application method(s)

Method: Manual dipping using a dip cup

Detailed description:

Contact time for dipping at 30 oC in dirty conditions:

| — | 5 minutes for bacteria and yeasts. |
| --- | --- |

—

5 minutes for bacteria and yeasts.

Application rate(s) and frequency

Application Rate: 5 to 10 ml per teat

Dilution (%): RTU product

Number and timing of application:

up to twice per day

Category(ies) of users

Professional

Pack sizes and packaging material

| | 1 000 litre HDPE container with HDPE closure; |
| --- | --- |

1 000 litre HDPE container with HDPE closure;

| | 200 litre plastic drum with HDPE closure; |
| --- | --- |

200 litre plastic drum with HDPE closure;

| | 25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap; |
| --- | --- |

25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap;

| | 5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap. |
| --- | --- |

5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap.

4.1.1.   Use-specific instructions for use

See general directions for use.

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

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

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

4.2.   Use description

Table 4.

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

| Product type | PT03 - Veterinary hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | | Scientific name: Bacteria |

Product type

PT03 - Veterinary hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: Bacteria

| | Common name: Bacteria |
| --- | --- |

Common name: Bacteria

| | Development stage: - |
| --- | --- |

Development stage: -

| | Scientific name: Yeasts |
| --- | --- |

Scientific name: Yeasts

| | Common name: Yeasts |
| --- | --- |

Common name: Yeasts

| | Development stage: - |
| --- | --- |

Development stage: -

Field(s) of use

Indoor

Teat disinfection post-milking by using hand-held sprayer

Application method(s)

Method: Manual spraying using hand-held sprayer

Detailed description:

Contact time for spraying at 30 oC in dirty conditions:

| — | 5 minutes for bacteria and yeasts. |
| --- | --- |

—

5 minutes for bacteria and yeasts.

Application rate(s) and frequency

Application Rate: 5 to 10 ml per teat

Dilution (%): RTU product

Number and timing of application:

up to twice per day

Category(ies) of users

Professional

Pack sizes and packaging material

| | 1 000 litre HDPE container with HDPE closure; |
| --- | --- |

1 000 litre HDPE container with HDPE closure;

| | 200 litre plastic drum with HDPE closure; |
| --- | --- |

200 litre plastic drum with HDPE closure;

| | 25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap; |
| --- | --- |

25 litre HDPE keg with DIN 61 or equivalent HDPE screw cap;

| | 5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap. |
| --- | --- |

5 litre HDPE keg with DIN 51 or equivalent HDPE screw cap.

4.2.1.   Use-specific instructions for use

See general directions for use.

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

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

4.2.2.   Use-specific risk mitigation measures

See general directions for use.

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

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

5.1.   Instructions for use

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

Always read the label or leaflet before use.

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

5.2.   Risk mitigation measures

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

Avoid hand to eye transfer.

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

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

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

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

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

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

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

5.4.   Instructions for safe disposal of the product and its packaging

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

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

| | Keep out of reach of children. |
| --- | --- |

Keep out of reach of children.

| | Store in original container tightly closed. |
| --- | --- |

Store in original container tightly closed.

| | Store between 0 °C and + 30 °C. |
| --- | --- |

Store between 0 °C and + 30 °C.

| | Shelf life: 24 months |
| --- | --- |

Shelf life: 24 months

6.   OTHER INFORMATION

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

| | EN ISO 16321 - Eye and face protection for occupational use |
| --- | --- |

EN ISO 16321 - Eye and face protection for occupational use

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

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

| | EN 455 - Medical gloves for single use |
| --- | --- |

EN 455 - Medical gloves for single use

7.   THIRD INFORMATION LEVEL: INDIVIDUAL PRODUCTS IN THE META SPC 2

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

| Trade name(s) | Synoshield | Market area: EU |
| --- | --- | --- |
| | Lactopost G | Market area: EU |
| Synoshield P | Market area: EU |
| Lactopost P | Market area: EU |
| Synoshield G | Market area: EU |
| Lactoshield | Market area: EU |
| Lactoshield Plus | Market area: EU |
| Lactoshield Extra | Market area: EU |
| Synoshield Extra | Market area: EU |
| Synoshield Plus | Market area: EU |
| Lactopost Protect | Market area: EU |
| Udder Shield | Market area: EU |
| Teat Care | Market area: EU |
| Mint Lacto Plus | Market area: EU |
| Lacto Care G | Market area: EU |
| Lactosal | Market area: EU |
| Lacto Care P | Market area: EU |
| Previoshield | Market area: EU |
| Authorisation number | EU-0030143-0003 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 4,0 |

Trade name(s)

Synoshield

Market area: EU

Lactopost G

Market area: EU

Synoshield P

Market area: EU

Lactopost P

Market area: EU

Synoshield G

Market area: EU

Lactoshield

Market area: EU

Lactoshield Plus

Market area: EU

Lactoshield Extra

Market area: EU

Synoshield Extra

Market area: EU

Synoshield Plus

Market area: EU

Lactopost Protect

Market area: EU

Udder Shield

Market area: EU

Teat Care

Market area: EU

Mint Lacto Plus

Market area: EU

Lacto Care G

Market area: EU

Lactosal

Market area: EU

Lacto Care P

Market area: EU

Previoshield

Market area: EU

Authorisation number

EU-0030143-0003 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

4,0

---

(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.

---

| 13.9.2023 | EN | Official Journal of the European Union | L 225/21 |
| --- | --- | --- | --- |

13.9.2023

EN

Official Journal of the European Union

L 225/21

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/1764

of 12 September 2023

granting a Union authorisation for the biocidal product family ‘Oxy’Pharm H2O2
  ’ 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 30 January 2017, OXY’PHARM submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘Oxy’Pharm H2O2’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-HC029658-43 in the Register for Biocidal Products. |
| --- | --- |

(1)

On 30 January 2017, OXY’PHARM submitted to the European Chemicals Agency (‘the Agency’) an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘Oxy’Pharm H2O2’ of product-types 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of the Netherlands had agreed to evaluate the application. The application was recorded under case number BC-HC029658-43 in the Register for Biocidal Products.

| (2) | ‘Oxy’Pharm H2O2’ contains hydrogen peroxide 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 for product-types 2 and 4. |
| --- | --- |

(2)

‘Oxy’Pharm H2O2’ contains hydrogen peroxide 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 for product-types 2 and 4.

| (3) | On 10 March 2022, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency. |
| --- | --- |

(3)

On 10 March 2022, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

| (4) | On 17 October 2022, the Agency submitted to the Commission its opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Oxy’Pharm H2O2’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. |
| --- | --- |

(4)

On 17 October 2022, the Agency submitted to the Commission its opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Oxy’Pharm H2O2’ 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 ‘Oxy’Pharm H2O2’ 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. |
| --- | --- |

(5)

The opinion concludes that ‘Oxy’Pharm H2O2’ 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 31 October 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. |
| --- | --- |

(6)

On 31 October 2022, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

| (7) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Oxy’Pharm H2O2’. |
| --- | --- |

(7)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Oxy’Pharm H2O2’.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(8)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,

HAS ADOPTED THIS REGULATION:

Article 1

A Union authorisation with authorisation number EU-0029752-0000 is granted to OXY’PHARM for the making available on the market and use of the biocidal product family ‘Oxy’Pharm H2O2’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union authorisation is valid from 3 October 2023 until 30 September 2033.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in the Member States in accordance with the Treaties.

Done at Brussels, 12 September 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 167, 27.6.2012, p. 1.

1

(2)  ECHA opinion of 14 June 2022 on the Union authorisation of ‘Oxy’Pharm H2O2
  ’ (ECHA/BPC/358/2022), https://echa.europa.eu/opinions-on-union-authorisation.

2

2

2

---

ANNEX

Summary of product characteristics for a biocidal product family

Oxy'Pharm H2O2

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

Product type 4 - Food and feed area (Disinfectants)

Authorisation number: EU-0029752-0000

R4BP asset number: EU-0029752-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

| Name | Oxy'Pharm H2O2 |
| --- | --- |

Name

Oxy'Pharm H2O2

1.2.   Product type(s)

| Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 - Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 - Food and feed area (Disinfectants)

1.3.   Authorisation holder

| Name and address of the authorisation holder | Name | OXY’PHARM |
| --- | --- | --- |
| Address | Rue Marcel Paul 829, 94500 Champigny-sur-Marne France |
| Authorisation number | EU-0029752-0000 |
| R4BP asset number | EU-0029752-0000 |
| Date of the authorisation | 3 October 2023 |
| Expiry date of the authorisation | 30 September 2033 |

Name and address of the authorisation holder

Name

OXY’PHARM

Address

Rue Marcel Paul 829, 94500 Champigny-sur-Marne France

Authorisation number

EU-0029752-0000

R4BP asset number

EU-0029752-0000

Date of the authorisation

3 October 2023

Expiry date of the authorisation

30 September 2033

1.4.   Manufacturer(s) of the biocidal products

| Name of manufacturer | OXY'PHARM |
| --- | --- |
| Address of manufacturer | Rue Marcel Paul, 829, 94500 Champigny-sur-Marne France |
| Location of manufacturing sites | Rue Marcel Paul, 829, 94500 Champigny-sur-Marne France |

Name of manufacturer

OXY'PHARM

Address of manufacturer

Rue Marcel Paul, 829, 94500 Champigny-sur-Marne France

Location of manufacturing sites

Rue Marcel Paul, 829, 94500 Champigny-sur-Marne France

1.5.   Manufacturer(s) of the active substance(s)

| Active substance | Hydrogen peroxide |
| --- | --- |
| Name of manufacturer | Evonik Resource Efficiency GmbH |
| Address of manufacturer | Rellinghauser Straße 1—11, 45128 Essen Germany |
| Location of manufacturing sites | Evonik Industries AG / BL Active Oxygens, Untere Kanalstrasse 3, 79618 Rheinfelden Germany |

Active substance

Hydrogen peroxide

Name of manufacturer

Evonik Resource Efficiency GmbH

Address of manufacturer

Rellinghauser Straße 1—11, 45128 Essen Germany

Location of manufacturing sites

Evonik Industries AG / BL Active Oxygens, Untere Kanalstrasse 3, 79618 Rheinfelden Germany

2.   PRODUCT FAMILY COMPOSITION AND FORMULATION

2.1.   Qualitative and quantitative information on the composition of the family

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Hydrogen peroxide | | Active Substance | 7722-84-1 | 231-765-0 | 6,0 | 12,0 |
| Silver | | Non-active substance | 7440-22-4 | 231-131-3 | 0,0 | 0,0017 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Hydrogen peroxide

Active Substance

7722-84-1

231-765-0

6,0

12,0

Silver

Non-active substance

7440-22-4

231-131-3

0,0

0,0017

2.2.   Type(s) of formulation

| Formulation(s) | AL - Any other liquid |
| --- | --- |

Formulation(s)

AL - Any other liquid

PART II

SECOND INFORMATION LEVEL - META SPC(S)

META SPC 1

1.   META SPC 1 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 1 identifier

| Identifier | Oxy'Pharm H2O2 6% |
| --- | --- |

Identifier

Oxy'Pharm H2O2 6%

1.2.   Suffix to the authorisation number

| Number | 1-1 |
| --- | --- |

Number

1-1

1.3.   Product type(s)

| Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.   META SPC 1 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 1

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Hydrogen peroxide | | Active Substance | 7722-84-1 | 231-765-0 | 6,0 | 6,0 |
| Silver | | Non-active substance | 7440-22-4 | 231-131-3 | 0,0017 | 0,0017 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Hydrogen peroxide

Active Substance

7722-84-1

231-765-0

6,0

6,0

Silver

Non-active substance

7440-22-4

231-131-3

0,0017

0,0017

2.2.   Type(s) of formulation of the meta SPC 1

| Formulation(s) | AL - Any other liquid |
| --- | --- |

Formulation(s)

AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

| Hazard statements | Causes serious eye irritation.
  Harmful to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Wash hands thoroughly after handling.
  Avoid release to the environment.
  Wear eye protection.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  If eye irritation persists: Get medical advice.
  Dispose of contents to hazardous or special waste collection point in accordance with national regulations.
  Dispose of container to hazardous or special waste collection point in accordance with national regulations. |

Hazard statements

Causes serious eye irritation.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Wash hands thoroughly after handling.

Avoid release to the environment.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

If eye irritation persists: Get medical advice.

Dispose of contents to hazardous or special waste collection point in accordance with national regulations.

Dispose of container to hazardous or special waste collection point in accordance with national regulations.

4.   AUTHORISED USE(S) OF THE META SPC 1

4.1.   Use description

Table 1

Use # 1 – Use #1.1: Hard surface disinfection by 6% Fogging Hydrogen Peroxide (FHP)

| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: -
  Common name: Bacteria
  Development stage: -
  Scientific name: -
  Common name: Yeasts
  Development stage: -
  Scientific name: -
  Common name: Tuberculosis bacilli
  Development stage: -
  Scientific name: -
  Common name: Viruses
  Development stage: -
  Scientific name: -
  Common name: Fungi
  Development stage: - |
| Field(s) of use | Indoor
  Room disinfection with fogging hydrogen peroxide (FHP) for rooms with volumes between 4-150 m3. It involves disinfection of hard non-porous surfaces of equipment and material (excluding medical devices) present in the treated room:






  — | Hospitals & clinics, |

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: -

Common name: Bacteria

Development stage: -

Scientific name: -

Common name: Yeasts

Development stage: -

Scientific name: -

Common name: Tuberculosis bacilli

Development stage: -

Scientific name: -

Common name: Viruses

Development stage: -

Scientific name: -

Common name: Fungi

Development stage: -

Field(s) of use

Indoor

Room disinfection with fogging hydrogen peroxide (FHP) for rooms with volumes between 4-150 m3. It involves disinfection of hard non-porous surfaces of equipment and material (excluding medical devices) present in the treated room:

—

Hospitals & clinics,

| — | laboratories of research and analysis (including P3 laboratories and white rooms), |
| --- | --- |

—

laboratories of research and analysis (including P3 laboratories and white rooms),

| — | healthcare transport, |
| --- | --- |

—

healthcare transport,

| — | pharmaceutical industry, |
| --- | --- |

—

pharmaceutical industry,

| — | industrial laundries, |
| --- | --- |

—

industrial laundries,

| — | dental surgery and implantology centres, |
| --- | --- |

—

dental surgery and implantology centres,

| — | hotels, |
| --- | --- |

—

hotels,

| — | schools, |
| --- | --- |

—

schools,

| — | day nurseries. |
| --- | --- |

—

day nurseries.

Application method(s)

Method: Fogging

Detailed description:

The product is a ready-to-use product that is placed in a device. That device automatically fogs the biocidal product, in the closed space/room to be disinfected, without any user or bystander present.

Application rate(s) and frequency

Application Rate:

Bactericidal, yeasticidal, fungicidal, tuberculocidal and virucidal activity: 5 ml product/m3 and 2 hours contact time. Treat a second time at 5 ml product/m3 and 2 hours contact time.

The second treatment takes place right after the first. The two treatments can be programmed in order to be carried out sequentially.

Droplet size: 1-15μM

Dilution (%): -

Number and timing of application:

Disinfect rooms and equipment as frequently as required by the hygiene protocol in place.

Category(ies) of users

Professional

Pack sizes and packaging material

| 1) | High density polyethylene HDPE, white (non-transparent) bottle of 1 litre with a degassing screw cap. |
| --- | --- |

1)

High density polyethylene HDPE, white (non-transparent) bottle of 1 litre with a degassing screw cap.

| 2) | HDPE, grey (non-transparent) single-use bottle of 2 litres. |
| --- | --- |

2)

HDPE, grey (non-transparent) single-use bottle of 2 litres.

| 3) | HDPE, white (non-transparent) can of 5 litres (refill packaging). |
| --- | --- |

3)

HDPE, white (non-transparent) can of 5 litres (refill packaging).

| 4) | HDPE, white (non-transparent) can of 20 litres. |
| --- | --- |

4)

HDPE, white (non-transparent) can of 20 litres.

4.1.1.   Use-specific instructions for use

Surfaces must be cleaned before disinfection. The product is ready-to-use and should be used without dilution. The product is designed for equipment such as Nocospray/Bio-sanitizer/Sanofog/Nocomax/Nocomax Easy/Glosair. Read the instructions for use before use. Use according to the following protocols:

| — | Bactericidal, yeasticidal, fungicidal, tuberculocidal and virucidal activity: 5 ml product/m3 and 2 hours contact time. Treat a second time at 5 ml product/m3 and 2 hours contact time. |
| --- | --- |

—

Bactericidal, yeasticidal, fungicidal, tuberculocidal and virucidal activity: 5 ml product/m3 and 2 hours contact time. Treat a second time at 5 ml product/m3 and 2 hours contact time.

The second treatment takes place right after the first. The two treatments can be programmed in order to be carried out sequentially.

| | Droplet size: 1-15μM |
| --- | --- |

Droplet size: 1-15μM

| | Relative Humidity: 25 % - 75 % |
| --- | --- |

Relative Humidity: 25 % - 75 %

| | Temperature: room temperature |
| --- | --- |

Temperature: room temperature

Respect the advised contact time. The contact time starts when the required amount of product is present in the room.

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.

4.1.2.   Use-specific risk mitigation measures

Please refer to general directions for use of this Meta SPC.

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

First aid

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

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

Likely direct or indirect effects

| — | causes serious eye irritation |
| --- | --- |

—

causes serious eye irritation

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

Please refer to general directions for use of this Meta SPC.

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

Please refer to general directions for use of this Meta SPC.

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

5.1.   Instructions for use

-

5.2.   Risk mitigation measures

During the diffusion, keep the room closed and do not enter. Treatment must be conducted with no human or animals present.

All gaps present in the room (for example, window frames) from where fog may leak must be sealed before the diffusion.

Ensure that access to the fog-treated area is denied during the whole procedure with a warning sign.

No access to the treated area should be permitted until the concentration of hydrogen peroxide is ≤0,9 ppm (1,25 mg/m3) or a lower relevant national reference value.

The professional user may enter the room only in emergency situations when the hydrogen peroxide level has dropped below 36ppm (50 mg/m3) and must wear the following Personal Protective Equipment (PPE): Respiratory Protective Equipment (RPE) classified under EN 14387 or equivalent with an Assigned Protection Factor (APF) 40 (Type of RPE to be specified by the authorisation holder within the product information) and suitable protective equipment (gloves classified under European Standard EN 374 or equivalent, eye protection consistent with European Standard EN ISO 16321 or equivalent, coverall). Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.

A measuring device should be used to ensure that the concentration of hydrogen peroxide has decreased below 0,9 ppm or a lower relevant national reference value. Unprotected persons/animals may re-enter the treated room only after the hydrogen peroxide concentration in air decreases lower than 1,25 mg/m3 (0,9 ppm) or a lower relevant national reference value.

Individual protective equipment:

Wear chemical resistant goggles consistent with European Standard EN ISO 16321 or equivalent as eye protection during mixing and loading of the product to the packaging that is directly used in the fogging device (such as Nocospray, Bio-sanitizer, Sanofog, Nocomax or Nocomax Easy).

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

-

5.4.   Instructions for safe disposal of the product and its packaging

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

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

| — | Shelf life: 2 years. |
| --- | --- |

—

Shelf life: 2 years.

6.   OTHER INFORMATION

The full titles of the EN standards mentioned in section 5.2 are listed below:

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

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

| | EN ISO 16321 - Eye and face protection for occupational use |
| --- | --- |

EN ISO 16321 - Eye and face protection for occupational use

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

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

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

| Trade name(s) | Nocolyse | Market area: EU |
| --- | --- | --- |
| | Glosair 400 | Market area: EU |
| Authorisation number | EU-0029752-0001 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Hydrogen peroxide | | Active Substance | 7722-84-1 | 231-765-0 | 6,0 |
| Silver | | Non-active substance | 7440-22-4 | 231-131-3 | 0,0017 |

Trade name(s)

Nocolyse

Market area: EU

Glosair 400

Market area: EU

Authorisation number

EU-0029752-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

Active Substance

7722-84-1

231-765-0

6,0

Silver

Non-active substance

7440-22-4

231-131-3

0,0017

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

| Trade name(s) | Nocolyse menthe | Market area: EU |
| --- | --- | --- |
| | Glosair 400 menthe | Market area: EU |
| Authorisation number | EU-0029752-0002 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Hydrogen peroxide | | Active Substance | 7722-84-1 | 231-765-0 | 6,0 |
| Silver | | Non-active substance | 7440-22-4 | 231-131-3 | 0,0017 |

Trade name(s)

Nocolyse menthe

Market area: EU

Glosair 400 menthe

Market area: EU

Authorisation number

EU-0029752-0002 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

Active Substance

7722-84-1

231-765-0

6,0

Silver

Non-active substance

7440-22-4

231-131-3

0,0017

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

| Trade name(s) | Nocolyse nocodor | Market area: EU |
| --- | --- | --- |
| | Glosair 400 nocodor | Market area: EU |
| Authorisation number | EU-0029752-0003 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Hydrogen peroxide | | Active Substance | 7722-84-1 | 231-765-0 | 6,0 |
| Silver | | Non-active substance | 7440-22-4 | 231-131-3 | 0,0017 |

Trade name(s)

Nocolyse nocodor

Market area: EU

Glosair 400 nocodor

Market area: EU

Authorisation number

EU-0029752-0003 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

Active Substance

7722-84-1

231-765-0

6,0

Silver

Non-active substance

7440-22-4

231-131-3

0,0017

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

| Identifier | Oxy'Pharm H2O2 12% |
| --- | --- |

Identifier

Oxy'Pharm H2O2 12%

1.2.   Suffix to the authorisation number

| Number | 1-2 |
| --- | --- |

Number

1-2

1.3.   Product type(s)

| Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

2.   META SPC 2 COMPOSITION

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

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Hydrogen peroxide | | Active Substance | 7722-84-1 | 231-765-0 | 12,0 | 12,0 |
| Silver | | Non-active substance | 7440-22-4 | 231-131-3 | 0,0017 | 0,0017 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Hydrogen peroxide

Active Substance

7722-84-1

231-765-0

12,0

12,0

Silver

Non-active substance

7440-22-4

231-131-3

0,0017

0,0017

2.2.   Type(s) of formulation of the meta SPC 2

| Formulation(s) | AL - Any other liquid |
| --- | --- |

Formulation(s)

AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

| Hazard statements | May intensify fire; oxidiser
  Causes serious eye damage.
  Harmful to aquatic life with long lasting effects. |
| --- | --- |
| Precautionary statements | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
  Keep away from clothing and other combustible materials.
  Avoid release to the environment.
  Wear eye protection.
  IF IN EYES: Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Immediately call a POISON CENTER.
  Immediately call a doctor.
  Dispose of contents to hazardous or special waste collection point in accordance with national regulations.
  Dispose of container to hazardous or special waste collection point in accordance with national regulations. |

Hazard statements

May intensify fire; oxidiser

Causes serious eye damage.

Harmful to aquatic life with long lasting effects.

Precautionary statements

Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.

Keep away from clothing and other combustible materials.

Avoid release to the environment.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.

Immediately call a POISON CENTER.

Immediately call a doctor.

Dispose of contents to hazardous or special waste collection point in accordance with national regulations.

Dispose of container to hazardous or special waste collection point in accordance with national regulations.

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

4.1.   Use description

Table 2

Use # 1 – Use #2.1: Hard surface disinfection by 12% Fogging Hydrogen Peroxide (FHP)

| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: -
  Common name: Bacteria
  Development stage: -
  Scientific name: -
  Common name: Yeasts
  Development stage: -
  Scientific name: -
  Common name: bacterial spores
  Development stage: -
  Scientific name: -
  Common name: Tuberculosis bacilli
  Development stage: -
  Scientific name: -
  Common name: Viruses
  Development stage: -
  Scientific name: -
  Common name: Fungi
  Development stage: - |
| Field(s) of use | Indoor
  Room disinfection with FHP for rooms with volumes between 4-150 m3. It involves disinfection of hard non-porous surfaces of equipment and material (excluding medical devices) present in the treated room:






  — | Hospitals & clinics, |

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: -

Common name: Bacteria

Development stage: -

Scientific name: -

Common name: Yeasts

Development stage: -

Scientific name: -

Common name: bacterial spores

Development stage: -

Scientific name: -

Common name: Tuberculosis bacilli

Development stage: -

Scientific name: -

Common name: Viruses

Development stage: -

Scientific name: -

Common name: Fungi

Development stage: -

Field(s) of use

Indoor

Room disinfection with FHP for rooms with volumes between 4-150 m3. It involves disinfection of hard non-porous surfaces of equipment and material (excluding medical devices) present in the treated room:

—

Hospitals & clinics,

| — | laboratories of research and analysis (including P3 laboratories and white rooms), |
| --- | --- |

—

laboratories of research and analysis (including P3 laboratories and white rooms),

| — | healthcare transport, |
| --- | --- |

—

healthcare transport,

| — | pharmaceutical industry, |
| --- | --- |

—

pharmaceutical industry,

| — | industrial laundries, |
| --- | --- |

—

industrial laundries,

| — | dental surgery and implantology centres, |
| --- | --- |

—

dental surgery and implantology centres,

| — | hotels, |
| --- | --- |

—

hotels,

| — | schools, |
| --- | --- |

—

schools,

| — | day nurseries. |
| --- | --- |

—

day nurseries.

Application method(s)

Method: Fogging

Detailed description:

The product is a ready-to-use product that is placed in a device. That device automatically fogs the biocidal product, in the closed space/room to be disinfected, without any user or bystander present.

Application rate(s) and frequency

Application Rate:

| — | Bactericidal, yeasticidal, fungicidal, sporicidal and virucidal activity: 3 ml product/m3 and 2 hours contact time. Treat a second time at 3 ml product/m3 and 2 hours contact time. |
| --- | --- |

—

Bactericidal, yeasticidal, fungicidal, sporicidal and virucidal activity: 3 ml product/m3 and 2 hours contact time. Treat a second time at 3 ml product/m3 and 2 hours contact time.

| — | Tuberculocidal activity: 5 ml product/m3 and 2 hours contact time. Treat a second time at 3 ml product/m3 and 2 hours contact time. |
| --- | --- |

—

Tuberculocidal activity: 5 ml product/m3 and 2 hours contact time. Treat a second time at 3 ml product/m3 and 2 hours contact time.

The second treatment takes place right after the first. The two treatments can be programmed in order to be carried out sequentially.

Droplet size: 1-15 μm

Dilution (%): -

Number and timing of application:

Disinfect rooms and equipment as frequently as required by the hygiene protocol in place.

Category(ies) of users

Professional

Pack sizes and packaging material

| 1) | HDPE, white (non-transparent) bottle of 1 litre with a degassing screw cap. |
| --- | --- |

1)

HDPE, white (non-transparent) bottle of 1 litre with a degassing screw cap.

| 2) | HDPE, grey (non-transparent) single-use bottle of 2 litres. |
| --- | --- |

2)

HDPE, grey (non-transparent) single-use bottle of 2 litres.

| 3) | HDPE, white (non-transparent) can of 5 litres (refill packaging). |
| --- | --- |

3)

HDPE, white (non-transparent) can of 5 litres (refill packaging).

| 4) | HDPE, white (non-transparent) can of 20 litres. |
| --- | --- |

4)

HDPE, white (non-transparent) can of 20 litres.

4.1.1.   Use-specific instructions for use

Surfaces must be cleaned before disinfection. The product is ready-to-use and should be used without dilution. The product is designed for equipment such as Nocospray/Bio-sanitizer/Sanofog/Nocomax/Nocomax Easy/Glosair. Read the instructions for use before use. Use according to the following protocols:

| — | Bactericidal, yeasticidal, fungicidal, sporicidal and virucidal activity: 3 ml product/m3 and 2 hours contact time. Treat a second time at 3 ml product/m3 and 2 hours contact time. |
| --- | --- |

—

Bactericidal, yeasticidal, fungicidal, sporicidal and virucidal activity: 3 ml product/m3 and 2 hours contact time. Treat a second time at 3 ml product/m3 and 2 hours contact time.

| — | Tuberculocidal activity: 5 ml product/m3 and 2 hours contact time. Treat a second time at 3 ml product/m3 and 2 hours contact time. |
| --- | --- |

—

Tuberculocidal activity: 5 ml product/m3 and 2 hours contact time. Treat a second time at 3 ml product/m3 and 2 hours contact time.

The second treatment takes place right after the first. The two treatments can be programmed in order to be carried out sequentially.

| | Droplet size: 1-15 μm |
| --- | --- |

Droplet size: 1-15 μm

| | Relative humidity: 25% - 75% |
| --- | --- |

Relative humidity: 25% - 75%

| | Temperature: room temperature |
| --- | --- |

Temperature: room temperature

Respect the contact time. The contact time starts when the required amount of product is present in the room.

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.

4.1.2.   Use-specific risk mitigation measures

Please refer to general directions for use of this Meta SPC.

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

First aid

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 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 INHALED: IF symptoms occur 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.

Likely direct or indirect effects

-

Causes serious eye irritation

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

Please refer to general directions for use of this Meta SPC.

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

Please refer to general directions for use of this Meta SPC.

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

5.1.   Instructions for use

-

5.2.   Risk mitigation measures

During the diffusion, keep the room closed and do not enter. Treatment must be conducted with no human or animals present.

All gaps present in the room (for example, window frames) from where fog may leak must be sealed before the diffusion.

Ensure that access to the fog-treated area is denied during the whole procedure with a warning sign.

No access to the treated areas should be permitted until the concentration of hydrogen peroxide is ≤0,9 ppm (1,25 mg/m3) or a lower relevant national reference value.

The professional user may enter the room only in emergency situations when the hydrogen peroxide level has dropped below 36 ppm (50 mg/m3) and must wear the following PPE: RPE classified under EN 14387 or equivalent with APF 40 (Type of RPE to be specified by the authorisation holder within the product information) and suitable protective equipment (gloves classified under European Standard EN 374 or equivalent, eye protection consistent with European Standard EN ISO 16321 or equivalent, coverall). Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.

A measuring device should be used to ensure that the concentration of hydrogen peroxide has decreased below 0,9 ppm or a lower relevant national reference value. Unprotected persons/animals may re-enter the treated room only after the hydrogen peroxide concentration in air decreases lower than 1,25 mg/m3 (0,9 ppm) or a lower relevant national reference value.

Individual protective equipment:

Wear chemical resistant goggles consistent with European Standard EN ISO 16321 or equivalent as eye protection during mixing and loading of the product to the packaging that is directly used in the fogging device (such as Nocospray, Bio-sanitizer, Sanofog, Nocomax or Nocomax Easy).

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

-

5.4.   Instructions for safe disposal of the product and its packaging

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

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

| — | Shelf life: 2 years. |
| --- | --- |

—

Shelf life: 2 years.

6.   OTHER INFORMATION

The full titles of the EN standards referenced section 5.2 are:

| | EN ISO 16321 - Eye and face protection for occupational users |
| --- | --- |

EN ISO 16321 - Eye and face protection for occupational users

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

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

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

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

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

| Trade name(s) | Nocolyse One Shot | Market area: EU |
| --- | --- | --- |
| | Nocolyse + | Market area: EU |
| Glosair 600 | Market area: EU |
| Authorisation number | EU-0029752-0004 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Hydrogen peroxide | | Active Substance | 7722-84-1 | 231-765-0 | 12,0 |
| Silver | | Non-active substance | 7440-22-4 | 231-131-3 | 0,0017 |

Trade name(s)

Nocolyse One Shot

Market area: EU

Nocolyse +

Market area: EU

Glosair 600

Market area: EU

Authorisation number

EU-0029752-0004 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

Active Substance

7722-84-1

231-765-0

12,0

Silver

Non-active substance

7440-22-4

231-131-3

0,0017

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

| Trade name(s) | Nocolyse One Shot menthe | Market area: EU |
| --- | --- | --- |
| | Nocolyse + menthe | Market area: EU |
| Glosair 600 menthe | Market area: EU |
| Authorisation number | EU-0029752-0005 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Hydrogen peroxide | | Active Substance | 7722-84-1 | 231-765-0 | 12,0 |
| Silver | | Non-active substance | 7440-22-4 | 231-131-3 | 0,0017 |

Trade name(s)

Nocolyse One Shot menthe

Market area: EU

Nocolyse + menthe

Market area: EU

Glosair 600 menthe

Market area: EU

Authorisation number

EU-0029752-0005 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

Active Substance

7722-84-1

231-765-0

12,0

Silver

Non-active substance

7440-22-4

231-131-3

0,0017

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

| Trade name(s) | Nocolyse One Shot nocodor | Market area: EU |
| --- | --- | --- |
| | Nocolyse + nocodor | Market area: EU |
| Glosair 600 nocodor | Market area: EU |
| Authorisation number | EU-0029752-0006 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Hydrogen peroxide | | Active Substance | 7722-84-1 | 231-765-0 | 12,0 |
| Silver | | Non-active substance | 7440-22-4 | 231-131-3 | 0,0017 |

Trade name(s)

Nocolyse One Shot nocodor

Market area: EU

Nocolyse + nocodor

Market area: EU

Glosair 600 nocodor

Market area: EU

Authorisation number

EU-0029752-0006 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

Active Substance

7722-84-1

231-765-0

12,0

Silver

Non-active substance

7440-22-4

231-131-3

0,0017

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

| Identifier | Oxy'Pharm H2O2 7.9% |
| --- | --- |

Identifier

Oxy'Pharm H2O2 7.9%

1.2.   Suffix to the authorisation number

| Number | 1-3 |
| --- | --- |

Number

1-3

1.3.   Product type(s)

| Product type(s) | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)
  PT04 - Food and feed area (Disinfectants) |
| --- | --- |

Product type(s)

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

PT04 - Food and feed area (Disinfectants)

2.   META SPC 3 COMPOSITION

2.1.   Qualitative and quantitative information on the composition of the meta SPC 3

| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| --- | --- | --- | --- | --- | --- |
| Min | Max |
| Hydrogen peroxide | | Active Substance | 7722-84-1 | 231-765-0 | 7,9 | 7,9 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Hydrogen peroxide

Active Substance

7722-84-1

231-765-0

7,9

7,9

2.2.   Type(s) of formulation of the meta SPC 3

| Formulation(s) | AL - Any other liquid |
| --- | --- |

Formulation(s)

AL - Any other liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

| Hazard statements | Causes serious eye irritation. |
| --- | --- |
| Precautionary statements | Wash hands thoroughly after handling.
  Wear eye protection.
  IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
  If eye irritation persists: Get medical advice. |

Hazard statements

Causes serious eye irritation.

Precautionary statements

Wash hands thoroughly after handling.

Wear eye protection.

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

If eye irritation persists: Get medical advice.

4.   AUTHORISED USE(S) OF THE META SPC 3

4.1.   Use description

Table 3

Use # 1 – Use #3.1: Hard surface disinfection by 7.9% Fogging Hydrogen Peroxide (FHP)

| Product type | PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | |
| Target organism(s) (including development stage) | Scientific name: -
  Common name: Bacteria
  Development stage: -
  Scientific name: -
  Common name: yeasts
  Development stage: -
  Scientific name: -
  Common name: Bacterial spores
  Development stage:
  Scientific name: -
  Common name: Mycobacteria
  Development stage: -
  Scientific name: -
  Common name: Viruses
  Development stage: -
  Scientific name: -
  Common name: Fungi
  Development stage: - |
| Field(s) of use | Indoor
  Room disinfection with FHP for rooms with volumes between 4-150 m3. It involves disinfection of hard non-porous surfaces of equipment and material (excluding medical devices) present in the treated room:






  — | Hospitals & clinics, |

Product type

PT02 - Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants)

Where relevant, an exact description of the authorised use

Target organism(s) (including development stage)

Scientific name: -

Common name: Bacteria

Development stage: -

Scientific name: -

Common name: yeasts

Development stage: -

Scientific name: -

Common name: Bacterial spores

Development stage:

Scientific name: -

Common name: Mycobacteria

Development stage: -

Scientific name: -

Common name: Viruses

Development stage: -

Scientific name: -

Common name: Fungi

Development stage: -

Field(s) of use

Indoor

Room disinfection with FHP for rooms with volumes between 4-150 m3. It involves disinfection of hard non-porous surfaces of equipment and material (excluding medical devices) present in the treated room:

—

Hospitals & clinics,

| — | laboratories of research and analysis (including P3 laboratories and white rooms), |
| --- | --- |

—

laboratories of research and analysis (including P3 laboratories and white rooms),

| — | healthcare transport, |
| --- | --- |

—

healthcare transport,

| — | pharmaceutical industry, |
| --- | --- |

—

pharmaceutical industry,

| — | industrial laundries, |
| --- | --- |

—

industrial laundries,

| — | dental surgery and implantology centres, |
| --- | --- |

—

dental surgery and implantology centres,

| — | transport vehicles |
| --- | --- |

—

transport vehicles

| — | hotels, |
| --- | --- |

—

hotels,

| — | restaurants, |
| --- | --- |

—

restaurants,

| — | schools, |
| --- | --- |

—

schools,

| — | day nurseries, |
| --- | --- |

—

day nurseries,

| — | veterinary clinics. |
| --- | --- |

—

veterinary clinics.

Application method(s)

Method: Fogging

Detailed description:

The product is a ready-to-use product that is placed in a device. That device automatically fogs the biocidal product, in the closed space/room to be disinfected, without any user or bystander present.

Application rate(s) and frequency

Application Rate:

| — | Bactericidal, yeasticidal, fungicidal, sporicidal, and virucidal activity: 5 ml product/m3 and 2 hours contact time. |
| --- | --- |

—

Bactericidal, yeasticidal, fungicidal, sporicidal, and virucidal activity: 5 ml product/m3 and 2 hours contact time.

| — | Mycobactericidal activity (log reduction ≥ 4): 7 ml product/m3 and 2 hours contact time. |
| --- | --- |

—

Mycobactericidal activity (log reduction ≥ 4): 7 ml product/m3 and 2 hours contact time.

Droplet size: 1-15 μm

Dilution (%): -

Number and timing of application:

Disinfect rooms and equipment as frequently as required by the hygiene protocol in place.

Category(ies) of users

Professional

Pack sizes and packaging material

| 1) | HDPE, white (non-transparent) bottle of 1 litre with a degassing screw cap. |
| --- | --- |

1)

HDPE, white (non-transparent) bottle of 1 litre with a degassing screw cap.

| 2) | HDPE, grey (non-transparent) single-use bottle of 2 litres. |
| --- | --- |

2)

HDPE, grey (non-transparent) single-use bottle of 2 litres.

| 3) | HDPE, white (non-transparent) can of 5 litres (refill packaging). |
| --- | --- |

3)

HDPE, white (non-transparent) can of 5 litres (refill packaging).

| 4) | HDPE, white (non-transparent) can of 20 litres. |
| --- | --- |

4)

HDPE, white (non-transparent) can of 20 litres.

4.1.1.   Use-specific instructions for use

Surfaces must be cleaned before disinfection. The product is ready-to-use and should be used without dilution. The product is designed for equipment such as Nocospray/Bio-sanitizer/Sanofog/Nocomax/Nocomax Easy/Glosair. Read the instructions for use before use. Use according to the following protocols:

| — | Bactericidal, yeasticidal, fungicidal, sporicidal, and virucidal activity: 5 ml product/m3 and 2 hours contact time. |
| --- | --- |

—

Bactericidal, yeasticidal, fungicidal, sporicidal, and virucidal activity: 5 ml product/m3 and 2 hours contact time.

| — | Mycobactericidal activity (log reduction ≥ 4): 7 ml product/m3 and 2 hours contact time.






  — | Droplet size: 1-15 μm |
| --- | --- | --- |

—

Mycobactericidal activity (log reduction ≥ 4): 7 ml product/m3 and 2 hours contact time.

—

Droplet size: 1-15 μm

| — | Relative humidity: 25 % - 75 % |
| --- | --- |

—

Relative humidity: 25 % - 75 %

| — | Temperature: room temperature |
| --- | --- |

—

Temperature: room temperature

Respect the contact time. The contact time starts when the required amount of product is present in the room.

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.

4.1.2.   Use-specific risk mitigation measures

Please refer to general directions for use of this Meta SPC.

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

First aid

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

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

Likely direct or indirect effects

| — | Causes severe eye irritation |
| --- | --- |

—

Causes severe eye irritation

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

Please refer to general directions for use of this Meta SPC.

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

Please refer to general directions for use of this Meta SPC.

4.2.   Use description

Table 4

Use # 2 – Use #3.3: Hard surface disinfection by Fogging Hydrogen Peroxide (FHP)

| Product type | PT04 - Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | - |
| Target organism(s) (including development stage) | Scientific name: -
  Common name: Bacteria
  Development stage: -
  Scientific name: -
  Common name: Yeasts
  Development stage: -
  Scientific name: -
  Common name: Bacterial spores
  Development stage: -
  Scientific name: -
  Common name: Mycobacteria
  Development stage: -
  Scientific name: -
  Common name: Viruses
  Development stage: -
  Scientific name: -
  Common name: bacteriophages
  Development stage: -
  Scientific name: -
  Common name: Fungi
  Development stage: - |
| Field(s) of use | Indoor
  Room disinfection with FHP disinfection of hard non-porous surfaces of equipment and material present in the treated room of a size between 4-150 m3:






  — | food industries, |

Product type

PT04 - Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

-

Target organism(s) (including development stage)

Scientific name: -

Common name: Bacteria

Development stage: -

Scientific name: -

Common name: Yeasts

Development stage: -

Scientific name: -

Common name: Bacterial spores

Development stage: -

Scientific name: -

Common name: Mycobacteria

Development stage: -

Scientific name: -

Common name: Viruses

Development stage: -

Scientific name: -

Common name: bacteriophages

Development stage: -

Scientific name: -

Common name: Fungi

Development stage: -

Field(s) of use

Indoor

Room disinfection with FHP disinfection of hard non-porous surfaces of equipment and material present in the treated room of a size between 4-150 m3:

—

food industries,

| — | central kitchens, |
| --- | --- |

—

central kitchens,

| — | restaurants. |
| --- | --- |

—

restaurants.

Application method(s)

Method: Fogging

Detailed description:

The product is a ready-to-use product that is placed in a device. That device automatically fogs the biocidal product, in the closed space/room to be disinfected, without any user or bystander present.

Application rate(s) and frequency

Application Rate:

| — | Bactericidal, bacteriophagicidal, yeasticidal, fungicidal, sporicidal, and virucidal activity: 5 ml product/m3 and 2 hours contact time. |
| --- | --- |

—

Bactericidal, bacteriophagicidal, yeasticidal, fungicidal, sporicidal, and virucidal activity: 5 ml product/m3 and 2 hours contact time.

| — | Mycobactericidal activity (log reduction ≥ 4): 7 ml product/m3 and 2 hours contact time. |
| --- | --- |

—

Mycobactericidal activity (log reduction ≥ 4): 7 ml product/m3 and 2 hours contact time.

Droplet size: 1-15 μm

Dilution (%): -

Number and timing of application:

Disinfect rooms and equipment as frequently as required by the hygiene protocol in place.

Category(ies) of users

Professional

Pack sizes and packaging material

| 1) | HDPE, white (non-transparent) bottle of 1litre with a degassing screw cap. |
| --- | --- |

1)

HDPE, white (non-transparent) bottle of 1litre with a degassing screw cap.

| 2) | HDPE, grey (non-transparent) single-use bottle of 2 litres. |
| --- | --- |

2)

HDPE, grey (non-transparent) single-use bottle of 2 litres.

| 3) | HDPE, white (non-transparent) can of 5 litres (refill packaging). |
| --- | --- |

3)

HDPE, white (non-transparent) can of 5 litres (refill packaging).

| 4) | HDPE, white (non-transparent) can of 20 litres. |
| --- | --- |

4)

HDPE, white (non-transparent) can of 20 litres.

4.2.1.   Use-specific instructions for use

Surfaces must be cleaned before disinfection. The product is ready-to-use and should be used without dilution. The product is designed for equipment such as Nocospray/Bio-sanitizer/Sanofog/Nocomax/Nocomax Easy/Glosair. Read the instructions for use before use. Use according to the following protocols:

| — | Bactericidal, bacteriophagicidal, yeasticidal, fungicidal, sporicidal and virucidal activity: 5 ml product/m3 and 2 hours contact time. |
| --- | --- |

—

Bactericidal, bacteriophagicidal, yeasticidal, fungicidal, sporicidal and virucidal activity: 5 ml product/m3 and 2 hours contact time.

| — | Mycobactericidal activity: 7 ml product/m3 and 2 hours contact time.






  — | droplet size: 1-15 μm |
| --- | --- | --- |

—

Mycobactericidal activity: 7 ml product/m3 and 2 hours contact time.

—

droplet size: 1-15 μm

| — | Relative humidity: 25 % - 75 % |
| --- | --- |

—

Relative humidity: 25 % - 75 %

| — | Temperature: room temperature |
| --- | --- |

—

Temperature: room temperature

Respect the contact time. The contact time starts when the required amount of product is present in the room. 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.

4.2.2.   Use-specific risk mitigation measures

Please refer to general directions for use of this Meta SPC.

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

First aid

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

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

Likely direct or indirect effects

| — | Causes severe eye irritation |
| --- | --- |

—

Causes severe eye irritation

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

Please refer to general directions for use of this Meta SPC.

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

Please refer to general directions for use of this Meta SPC.

5.   GENERAL DIRECTIONS FOR USE (3)
  OF THE META SPC 3

5.1.   Instructions for use

-

5.2.   Risk mitigation measures

During the diffusion, keep the room closed and do not enter in. Treatment must be conducted with no human or animals present.

All gaps present in the room (for example, window frames) from where fog may leak must be sealed before the diffusion.

Ensure that access to the fog-treated area is denied during the whole procedure with a warning sign.

No access to the treated areas should be permitted until the concentration of hydrogen peroxide is ≤0,9 ppm (1,25 mg/m3) or a lower relevant national reference value.

The professional user may enter the room only in emergency situations when the hydrogen peroxide level has dropped below 36ppm (50 mg/m3) and must wear the following PPE: RPE classified under EN 14387 or equivalent with APF 40 (Type of RPE to be specified by the authorisation holder within the product information) and suitable protective equipment (gloves classified under European Standard EN 374 or equivalent, eye protection consistent with European Standard EN ISO 16321 or equivalent, coverall). Gloves and coverall material to be specified by the authorisation holder within the product information. See section 6 for the full titles of the EN standards.

A measuring device should be used to ensure that the concentration of hydrogen peroxide has decreased below 0,9 ppm or a lower relevant national reference value. Unprotected persons/animals may re-enter the treated room only after the hydrogen peroxide concentration in air decreases lower than 1,25 mg/m3 (0,9 ppm) or a lower relevant national reference value.

Individual protective equipment:

Wear chemical resistant goggles consistent with European Standard EN ISO 16321 or equivalent as eye protection during mixing and loading of the product to the packaging that is directly used in the fogging device (such as Nocospray, Bio-sanitizer, Sanofog, Nocomax or Nocomax Easy).

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

-

5.4.   Instructions for safe disposal of the product and its packaging

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

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

| — | Shelf life: 2 years. |
| --- | --- |

—

Shelf life: 2 years.

6.   OTHER INFORMATION

The full titles of the EN standards referenced in section 5.2 are:

| | EN ISO 16321 - Eye and face protection for occupational users |
| --- | --- |

EN ISO 16321 - Eye and face protection for occupational users

| | EN 374 – Protective gloves against chemicals and micro-organisms |
| --- | --- |

EN 374 – Protective gloves against chemicals and micro-organisms

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

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

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

| Trade name(s) | Nocolyse Food | Market area: EU |
| --- | --- | --- |
| | Glosair 500 | Market area: EU |
| Authorisation number | EU-0029752-0007 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Hydrogen peroxide | | Active Substance | 7722-84-1 | 231-765-0 | 7,9 |

Trade name(s)

Nocolyse Food

Market area: EU

Glosair 500

Market area: EU

Authorisation number

EU-0029752-0007 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Hydrogen peroxide

Active Substance

7722-84-1

231-765-0

7,9

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(1)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 1.

(2)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 2.

(3)  Instructions for use, risk mitigation measures and other directions for use under this section are valid for any authorised uses within the meta SPC 3.

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