# Official Journal L 297/2022

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 297 |
| | |
| English edition | Legislation | Volume 6517 November 2022 |

ISSN 1977-0677

Official Journal

of the European Union

L 297

English edition

Legislation

Volume 6517 November 2022

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2022/2252 of 11 November 2022 granting a Union authorisation for the biocidal product family Brenntag GmbH Propan-2-ol Product Family (
  1
  ) | 1 |
| | * | Commission Implementing Regulation (EU) 2022/2253 of 14 November 2022 granting a Union authorisation for the biocidal product family Colgate-Palmolive Lactic acid PT 2 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  ) | 33 |
| | | DECISIONS |
| | * | Council Implementing Decision (EU) 2022/2254 of 14 November 2022 authorising Bulgaria to introduce a special measure derogating from Article 287 of Directive 2006/112/EC on the common system of value added tax | 69 |
| | * | Commission Decision (EU) 2022/2255 of 24 October 2022 on the initiation of the detailed examination of certain performance targets contained in the revised draft performance plan for the third reference period submitted at functional airspace block level by Belgium, Germany, France, Luxembourg, and the Netherlands pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council
  (notified under document C(2022) 7438)

   (
  1
  ) | 71 |
| | * | Commission Decision (EU) 2022/2256 of 15 November 2022 on the initiation of the detailed examination of certain performance targets contained in the revised draft performance plan for the third reference period submitted at functional airspace block level by Switzerland pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council
  (notified under document C(2022) 8076)

   (
  1
  ) | 80 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2022/2252 of 11 November 2022 granting a Union authorisation for the biocidal product family Brenntag GmbH Propan-2-ol Product Family (
  1
  )

1

1

*

Commission Implementing Regulation (EU) 2022/2253 of 14 November 2022 granting a Union authorisation for the biocidal product family Colgate-Palmolive Lactic acid PT 2 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (
  1
  )

1

33

DECISIONS

*

Council Implementing Decision (EU) 2022/2254 of 14 November 2022 authorising Bulgaria to introduce a special measure derogating from Article 287 of Directive 2006/112/EC on the common system of value added tax

69

*

Commission Decision (EU) 2022/2255 of 24 October 2022 on the initiation of the detailed examination of certain performance targets contained in the revised draft performance plan for the third reference period submitted at functional airspace block level by Belgium, Germany, France, Luxembourg, and the Netherlands pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council
  (notified under document C(2022) 7438)

   (
  1
  )

(notified under document C(2022) 7438)

1

71

*

Commission Decision (EU) 2022/2256 of 15 November 2022 on the initiation of the detailed examination of certain performance targets contained in the revised draft performance plan for the third reference period submitted at functional airspace block level by Switzerland pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council
  (notified under document C(2022) 8076)

   (
  1
  )

(notified under document C(2022) 8076)

1

80

| | | Corrigenda |
| --- | --- | --- |
| | * | Corrigendum to Commission Implementing Regulation (EU) 2019/1383 of 8 July 2019 amending and correcting Regulation (EU) No 1321/2014 as regards safety management systems in continuing airworthiness management organisations and alleviations for general aviation aircraft concerning maintenance and continuing airworthiness management ( OJ L 228, 4.9.2019 ) | 83 |
| | * | Corrigendum to Council Decision (EU) 2022/1975 of 13 October 2022 on the position to be taken on behalf of the European Union within the Trade Committee established by the Free Trade Agreement between the European Union and its Member States, of the one part, and the Republic of Korea, of the other part as regards the amendment of Annexes 10-A and 10-B to the Agreement ( OJ L 271, 19.10.2022 ) | 84 |

Corrigenda

*

Corrigendum to Commission Implementing Regulation (EU) 2019/1383 of 8 July 2019 amending and correcting Regulation (EU) No 1321/2014 as regards safety management systems in continuing airworthiness management organisations and alleviations for general aviation aircraft concerning maintenance and continuing airworthiness management ( OJ L 228, 4.9.2019 )

( OJ L 228, 4.9.2019 )

83

*

Corrigendum to Council Decision (EU) 2022/1975 of 13 October 2022 on the position to be taken on behalf of the European Union within the Trade Committee established by the Free Trade Agreement between the European Union and its Member States, of the one part, and the Republic of Korea, of the other part as regards the amendment of Annexes 10-A and 10-B to the Agreement ( OJ L 271, 19.10.2022 )

( OJ L 271, 19.10.2022 )

84

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

---

(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

| 17.11.2022 | EN | Official Journal of the European Union | L 297/1 |
| --- | --- | --- | --- |

17.11.2022

EN

Official Journal of the European Union

L 297/1

---

COMMISSION IMPLEMENTING REGULATION (EU) 2022/2252

of 11 November 2022

granting a Union authorisation for the biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

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

Whereas:

| (1) | On 30 June 2016, Brenntag GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Brenntag GmbH Propan-2-ol Product Family’ of product-types 1, 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Germany had agreed to evaluate the application. The application was recorded under case number BC-BL025673-43 in the Register for Biocidal Products. |
| --- | --- |

(1)

On 30 June 2016, Brenntag GmbH submitted an application in accordance with Article 43(1) of Regulation (EU) No 528/2012 for authorisation of a biocidal product family named ‘Brenntag GmbH Propan-2-ol Product Family’ of product-types 1, 2 and 4, as described in Annex V to that Regulation, providing written confirmation that the competent authority of Germany had agreed to evaluate the application. The application was recorded under case number BC-BL025673-43 in the Register for Biocidal Products.

| (2) | ‘Brenntag GmbH Propan-2-ol Product Family’ contains propan-2-ol as the active substance, which is included in the Union list of approved active substance referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 1, 2 and 4. |
| --- | --- |

(2)

‘Brenntag GmbH Propan-2-ol Product Family’ contains propan-2-ol as the active substance, which is included in the Union list of approved active substance referred to in Article 9(2) of Regulation (EU) No 528/2012 for product-types 1, 2 and 4.

| (3) | On 15 March 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’). |
| --- | --- |

(3)

On 15 March 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the European Chemicals Agency (‘the Agency’).

| (4) | On 4 November 2021, the Agency submitted to the Commission an opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Brenntag GmbH Propan-2-ol Product Family’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012. |
| --- | --- |

(4)

On 4 November 2021, the Agency submitted to the Commission an opinion (2), including the draft summary of the biocidal product characteristics (‘SPC’) of ‘Brenntag GmbH Propan-2-ol Product Family’ and the final assessment report on the biocidal product family in accordance with Article 44(3) of Regulation (EU) No 528/2012.

| (5) | The opinion concludes that ‘Brenntag GmbH Propan-2-ol Product Family’ is a ‘biocidal product family’ within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. |
| --- | --- |

(5)

The opinion concludes that ‘Brenntag GmbH Propan-2-ol Product Family’ is a ‘biocidal product family’ within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation.

| (6) | On 22 November 2021, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012. |
| --- | --- |

(6)

On 22 November 2021, the Agency transmitted to the Commission the draft SPC in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

| (7) | The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Brenntag GmbH Propan-2-ol Product Family’. |
| --- | --- |

(7)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Brenntag GmbH Propan-2-ol Product Family’.

| (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-0027707-0000 is granted to Brenntag GmbH for the making available on the market and use of the biocidal product family ‘Brenntag GmbH Propan-2-ol Product Family’ in accordance with the summary of the biocidal product characteristics set out in the Annex.

The Union Authorisation is valid from 7 December 2022 to 30 November 2032.

Article 2

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

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

Done at Brussels, 11 November 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(2)  ECHA opinion of 7 October 2021 on the Union authorisation of ‘Brenntag GmbH Propan-2-ol Product Family’ (ECHA/BPC/290/2021), https://echa.europa.eu/bpc-opinions-on-union-authorisation

2

---

ANNEX

Summary of product characteristics for a biocidal product family

Brenntag GmbH Propan-2-ol Product Family

Product type 1 – Human hygiene (Disinfectants)

Product type 4 – Food and feed area (Disinfectants)

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

Authorisation number: EU-0027707-0000

R4BP asset number: EU-0027707-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

| Name | Brenntag GmbH Propan-2-ol Product Family |
| --- | --- |

Name

Brenntag GmbH Propan-2-ol Product Family

1.2.   Product type(s)

| Product type(s) | PT01 – Human hygiene (Disinfectants)
  PT04 – Food and feed area (Disinfectants)
  PT02 – Disinfectants and algaecides not intended for direct application to humans or animals (Disinfectants) |
| --- | --- |

Product type(s)

PT01 – Human hygiene (Disinfectants)

PT04 – Food and feed area (Disinfectants)

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

1.3.   Authorisation holder

| Name and address of the authorisation holder | Name | Brenntag GmbH |
| --- | --- | --- |
| Address | Messeallee 11, 45131 Essen Germany |
| Authorisation number | EU-0027707-0000 |
| R4BP asset number | EU-0027707-0000 |
| Date of the authorisation | 7 December 2022 |
| Expiry date of the authorisation | 30 November 2032 |

Name and address of the authorisation holder

Name

Brenntag GmbH

Address

Messeallee 11, 45131 Essen Germany

Authorisation number

EU-0027707-0000

R4BP asset number

EU-0027707-0000

Date of the authorisation

7 December 2022

Expiry date of the authorisation

30 November 2032

1.4.   Manufacturer(s) of the biocidal products

| Name of manufacturer | Kesla Pharma Wolfen GmbH |
| --- | --- |
| Address of manufacturer | Kesla-Str. 1, 06803 Bitterfeld Germany |
| Location of manufacturing sites | Kesla-Str. 1, 06803 Bitterfeld Germany |

Name of manufacturer

Kesla Pharma Wolfen GmbH

Address of manufacturer

Kesla-Str. 1, 06803 Bitterfeld Germany

Location of manufacturing sites

Kesla-Str. 1, 06803 Bitterfeld Germany

| Name of manufacturer | Dreve GmbH |
| --- | --- |
| Address of manufacturer | Max-Planck-Str. 31, 59423 Unna Germany |
| Location of manufacturing sites | Kesla Pharma Wolfen GmbH, Kesla-Str. 1, 06803 Bitterfeld Germany |

Name of manufacturer

Dreve GmbH

Address of manufacturer

Max-Planck-Str. 31, 59423 Unna Germany

Location of manufacturing sites

Kesla Pharma Wolfen GmbH, Kesla-Str. 1, 06803 Bitterfeld Germany

| Name of manufacturer | Buzil-Werk Wagner GmbH & Co. KG |
| --- | --- |
| Address of manufacturer | Fraunhoferstr. 17, 87700 Memmingen Germany |
| Location of manufacturing sites | Fraunhoferstr. 17, 87700 Memmingen Germany |

Name of manufacturer

Buzil-Werk Wagner GmbH & Co. KG

Address of manufacturer

Fraunhoferstr. 17, 87700 Memmingen Germany

Location of manufacturing sites

Fraunhoferstr. 17, 87700 Memmingen Germany

| Name of manufacturer | Wigol W. Stache GmbH |
| --- | --- |
| Address of manufacturer | Textorstr. 2, 67547 Worms Germany |
| Location of manufacturing sites | Textorstr. 2, 67547 Worms Germany |

Name of manufacturer

Wigol W. Stache GmbH

Address of manufacturer

Textorstr. 2, 67547 Worms Germany

Location of manufacturing sites

Textorstr. 2, 67547 Worms Germany

| Name of manufacturer | KiiltoClean Oy |
| --- | --- |
| Address of manufacturer | Tengströminkatu 6, FI-20630 Turku Finland |
| Location of manufacturing sites | PL 157, FI-20101 Turku Finland |

Name of manufacturer

KiiltoClean Oy

Address of manufacturer

Tengströminkatu 6, FI-20630 Turku Finland

Location of manufacturing sites

PL 157, FI-20101 Turku Finland

| Name of manufacturer | Witty GmbH und Co. KG |
| --- | --- |
| Address of manufacturer | Herrenrothstr. 12, 86424 Dinkelscherben Germany |
| Location of manufacturing sites | Herrenrothstr. 12, 86424 Dinkelscherben Germany |

Name of manufacturer

Witty GmbH und Co. KG

Address of manufacturer

Herrenrothstr. 12, 86424 Dinkelscherben Germany

Location of manufacturing sites

Herrenrothstr. 12, 86424 Dinkelscherben Germany

| Name of manufacturer | Carl Roth GmbH und Co. KG |
| --- | --- |
| Address of manufacturer | An der Mole 5, 76189 Karlsruhe Germany |
| Location of manufacturing sites | An der Mole 5, 76189 Karlsruhe Germany |

Name of manufacturer

Carl Roth GmbH und Co. KG

Address of manufacturer

An der Mole 5, 76189 Karlsruhe Germany

Location of manufacturing sites

An der Mole 5, 76189 Karlsruhe Germany

| Name of manufacturer | Pro-cura Hy-med GmbH |
| --- | --- |
| Address of manufacturer | Stresemannstrasse 364, 22761 Hamburg Germany |
| Location of manufacturing sites | A.F.P., Otto-Brenner-Str. 16, 21337 Lüneburg Germany |

Name of manufacturer

Pro-cura Hy-med GmbH

Address of manufacturer

Stresemannstrasse 364, 22761 Hamburg Germany

Location of manufacturing sites

A.F.P., Otto-Brenner-Str. 16, 21337 Lüneburg Germany

| Name of manufacturer | Pico-medical GmbH |
| --- | --- |
| Address of manufacturer | Fangdieckstr. 24, 22547 Hamburg Germany |
| Location of manufacturing sites | A.F.P., Otto-Brenner-Str. 16, 21337 Lüneburg Germany |

Name of manufacturer

Pico-medical GmbH

Address of manufacturer

Fangdieckstr. 24, 22547 Hamburg Germany

Location of manufacturing sites

A.F.P., Otto-Brenner-Str. 16, 21337 Lüneburg Germany

| Name of manufacturer | Anti-Germ International GmbH |
| --- | --- |
| Address of manufacturer | Oberbrühlstr. 16, 87700 Memmingen Germany |
| Location of manufacturing sites | Oberbrühlstr. 16, 87700 Memmingen Germany |

Name of manufacturer

Anti-Germ International GmbH

Address of manufacturer

Oberbrühlstr. 16, 87700 Memmingen Germany

Location of manufacturing sites

Oberbrühlstr. 16, 87700 Memmingen Germany

| Name of manufacturer | LCI FLOWEY |
| --- | --- |
| Address of manufacturer | 2 ZAC Klengbusbierg, 7795 Bissen Luxembourg |
| Location of manufacturing sites | 2 ZAC Klengbusbierg, 7795 Bissen Luxembourg |

Name of manufacturer

LCI FLOWEY

Address of manufacturer

2 ZAC Klengbusbierg, 7795 Bissen Luxembourg

Location of manufacturing sites

2 ZAC Klengbusbierg, 7795 Bissen Luxembourg

| Name of manufacturer | Hofmann & Sommer GmbH und Co. KG |
| --- | --- |
| Address of manufacturer | Lindenstr.11, 07426 Königsee-Rottenbach Germany |
| Location of manufacturing sites | Lindenstr.11, 07426 Königsee-Rottenbach Germany |

Name of manufacturer

Hofmann & Sommer GmbH und Co. KG

Address of manufacturer

Lindenstr.11, 07426 Königsee-Rottenbach Germany

Location of manufacturing sites

Lindenstr.11, 07426 Königsee-Rottenbach Germany

| Name of manufacturer | Girelli Alcool srl |
| --- | --- |
| Address of manufacturer | Via Thomas Edison 5, 20080 Zibido San Giacomo (MI) Italy |
| Location of manufacturing sites | Via Thomas Edison 5, 20080 Zibido San Giacomo (MI) Italy |

Name of manufacturer

Girelli Alcool srl

Address of manufacturer

Via Thomas Edison 5, 20080 Zibido San Giacomo (MI) Italy

Location of manufacturing sites

Via Thomas Edison 5, 20080 Zibido San Giacomo (MI) Italy

| Name of manufacturer | Brenntag S.p.A. |
| --- | --- |
| Address of manufacturer | Via Cusago 150/4, 20158 Milano (MI) Italy |
| Location of manufacturing sites | Via Cusago 150/4, 20158 Milano (MI) Italy |

Name of manufacturer

Brenntag S.p.A.

Address of manufacturer

Via Cusago 150/4, 20158 Milano (MI) Italy

Location of manufacturing sites

Via Cusago 150/4, 20158 Milano (MI) Italy

| Name of manufacturer | I.C.F. Srl |
| --- | --- |
| Address of manufacturer | Via G.B. Benzoni 50, 26020 Palazzo Pignano (CR) Italy |
| Location of manufacturing sites | Via G.B. Benzoni 50, 26020 Palazzo Pignano (CR) Italy |

Name of manufacturer

I.C.F. Srl

Address of manufacturer

Via G.B. Benzoni 50, 26020 Palazzo Pignano (CR) Italy

Location of manufacturing sites

Via G.B. Benzoni 50, 26020 Palazzo Pignano (CR) Italy

| Name of manufacturer | Brenntag SA |
| --- | --- |
| Address of manufacturer | 90 Avenue du Progrès, 69 680 Chassieu France |
| Location of manufacturing sites | 90 Avenue du Progrès, 69 680 Chassieu France |

Name of manufacturer

Brenntag SA

Address of manufacturer

90 Avenue du Progrès, 69 680 Chassieu France

Location of manufacturing sites

90 Avenue du Progrès, 69 680 Chassieu France

| Name of manufacturer | Brenntag GmbH |
| --- | --- |
| Address of manufacturer | Stinnes-Platz 1, 45472 Muelheim a.d. Ruhr Germany |
| Location of manufacturing sites | Stinnes-Platz 1, 45472 Muelheim a.d. Ruhr Germany |

Name of manufacturer

Brenntag GmbH

Address of manufacturer

Stinnes-Platz 1, 45472 Muelheim a.d. Ruhr Germany

Location of manufacturing sites

Stinnes-Platz 1, 45472 Muelheim a.d. Ruhr Germany

| Name of manufacturer | BCD Chemie GmbH |
| --- | --- |
| Address of manufacturer | Schellerdamm 16, 21079 Hamburg Germany |
| Location of manufacturing sites | Schellerdamm 16, 21079 Hamburg Germany |

Name of manufacturer

BCD Chemie GmbH

Address of manufacturer

Schellerdamm 16, 21079 Hamburg Germany

Location of manufacturing sites

Schellerdamm 16, 21079 Hamburg Germany

| Name of manufacturer | HYDRACHIM |
| --- | --- |
| Address of manufacturer | Z.A. ROUTE DE ST POIX, 35370 LE PERTRE France |
| Location of manufacturing sites | Z.A. du piquet, 35370 Etrelles France |

Name of manufacturer

HYDRACHIM

Address of manufacturer

Z.A. ROUTE DE ST POIX, 35370 LE PERTRE France

Location of manufacturing sites

Z.A. du piquet, 35370 Etrelles France

| Name of manufacturer | Langguth Chemie GmbH |
| --- | --- |
| Address of manufacturer | Wandalenstrasse 6, 86343 Königsbrunn Germany |
| Location of manufacturing sites | Wandalenstrasse 6, 86343 Königsbrunn Germany |

Name of manufacturer

Langguth Chemie GmbH

Address of manufacturer

Wandalenstrasse 6, 86343 Königsbrunn Germany

Location of manufacturing sites

Wandalenstrasse 6, 86343 Königsbrunn Germany

| Name of manufacturer | Burgess Galvin & Co |
| --- | --- |
| Address of manufacturer | Jamestown Road, 11 Finglas, Dublin Ireland |
| Location of manufacturing sites | Jamestown Road, 11 Finglas, Dublin Ireland |

Name of manufacturer

Burgess Galvin & Co

Address of manufacturer

Jamestown Road, 11 Finglas, Dublin Ireland

Location of manufacturing sites

Jamestown Road, 11 Finglas, Dublin Ireland

| Name of manufacturer | Tristel |
| --- | --- |
| Address of manufacturer | Lynx Business Park, Fordham Road, CB8 7NY Snailwell, Cambridge United Kingdom |
| Location of manufacturing sites | Lynx Business Park, Fordham Road, CB8 7NY Snailwell, Cambridge United Kingdom |

Name of manufacturer

Tristel

Address of manufacturer

Lynx Business Park, Fordham Road, CB8 7NY Snailwell, Cambridge United Kingdom

Location of manufacturing sites

Lynx Business Park, Fordham Road, CB8 7NY Snailwell, Cambridge United Kingdom

| Name of manufacturer | Brenntag Schweizerhall |
| --- | --- |
| Address of manufacturer | Elsässerstrasse 231, 4056 Basel Switzerland |
| Location of manufacturing sites | Elsässerstrasse 231, 4056 Basel Switzerland |

Name of manufacturer

Brenntag Schweizerhall

Address of manufacturer

Elsässerstrasse 231, 4056 Basel Switzerland

Location of manufacturing sites

Elsässerstrasse 231, 4056 Basel Switzerland

| Name of manufacturer | ORAPI |
| --- | --- |
| Address of manufacturer | 5 Allee des Cerdes, Pi de la Plaine de L’ain, 01150 Saint Vulbas France |
| Location of manufacturing sites | 5 Allee des Cerdes, Pi de la Plaine de L’ain, 01150 Saint Vulbas France |

Name of manufacturer

ORAPI

Address of manufacturer

5 Allee des Cerdes, Pi de la Plaine de L’ain, 01150 Saint Vulbas France

Location of manufacturing sites

5 Allee des Cerdes, Pi de la Plaine de L’ain, 01150 Saint Vulbas France

| Name of manufacturer | Copak S.A. |
| --- | --- |
| Address of manufacturer | Z.I. du Madrillet, rue de la Chênaie, 76800 Saint-Etienne-du-Rouvray France |
| Location of manufacturing sites | Z.I. du Madrillet, rue de la Chênaie, 76800 Saint-Etienne-du-Rouvray France |

Name of manufacturer

Copak S.A.

Address of manufacturer

Z.I. du Madrillet, rue de la Chênaie, 76800 Saint-Etienne-du-Rouvray France

Location of manufacturing sites

Z.I. du Madrillet, rue de la Chênaie, 76800 Saint-Etienne-du-Rouvray France

| Name of manufacturer | Water Technology Limited |
| --- | --- |
| Address of manufacturer | TOGHER INDUSTRIAL EST, T12KPF2 CORK, DUBLIN Ireland |
| Location of manufacturing sites | TOGHER INDUSTRIAL EST, T12KPF2 CORK, DUBLIN Ireland |

Name of manufacturer

Water Technology Limited

Address of manufacturer

TOGHER INDUSTRIAL EST, T12KPF2 CORK, DUBLIN Ireland

Location of manufacturing sites

TOGHER INDUSTRIAL EST, T12KPF2 CORK, DUBLIN Ireland

| Name of manufacturer | AF International, Electrolube: Divisions of H K Wentworth Ltd |
| --- | --- |
| Address of manufacturer | AASHBY PARK, COALFIELD WAY, ASHBY DE LA ZOUCH, LE65 1JF LEICESTERSHIRE United Kingdom |
| Location of manufacturing sites | AASHBY PARK, COALFIELD WAY, ASHBY DE LA ZOUCH, LE65 1JF LEICESTERSHIRE United Kingdom |

Name of manufacturer

AF International, Electrolube: Divisions of H K Wentworth Ltd

Address of manufacturer

AASHBY PARK, COALFIELD WAY, ASHBY DE LA ZOUCH, LE65 1JF LEICESTERSHIRE United Kingdom

Location of manufacturing sites

AASHBY PARK, COALFIELD WAY, ASHBY DE LA ZOUCH, LE65 1JF LEICESTERSHIRE United Kingdom

| Name of manufacturer | Bello Mondo bvba |
| --- | --- |
| Address of manufacturer | Helststraat 150-159, 2630 Aartselaar Belgium |
| Location of manufacturing sites | Laboratoria Smeets N.V., Fotografielaan 42, B-2610 Antwerpen-Wilrijk Belgium |

Name of manufacturer

Bello Mondo bvba

Address of manufacturer

Helststraat 150-159, 2630 Aartselaar Belgium

Location of manufacturing sites

Laboratoria Smeets N.V., Fotografielaan 42, B-2610 Antwerpen-Wilrijk Belgium

| Name of manufacturer | CERICHEM BIOPHARM SRL |
| --- | --- |
| Address of manufacturer | Viale Einaudi snc (z.i.), 71042 Cerignola (FG) Italy |
| Location of manufacturing sites | Viale Einaudi snc (z.i.), 71042 Cerignola (FG) Italy |

Name of manufacturer

CERICHEM BIOPHARM SRL

Address of manufacturer

Viale Einaudi snc (z.i.), 71042 Cerignola (FG) Italy

Location of manufacturing sites

Viale Einaudi snc (z.i.), 71042 Cerignola (FG) Italy

| Name of manufacturer | Otto Fischar GmbH & Co. KG |
| --- | --- |
| Address of manufacturer | Kaiserstr. 221, 66133 Saarbruecken Germany |
| Location of manufacturing sites | Kaiserstr. 221, 66133 Saarbruecken Germany |

Name of manufacturer

Otto Fischar GmbH & Co. KG

Address of manufacturer

Kaiserstr. 221, 66133 Saarbruecken Germany

Location of manufacturing sites

Kaiserstr. 221, 66133 Saarbruecken Germany

| Name of manufacturer | Caesar & Loretz GmbH |
| --- | --- |
| Address of manufacturer | Herderstr. 31, 40721 Hilden Germany |
| Location of manufacturing sites | Herderstr. 31, 40721 Hilden Germany |

Name of manufacturer

Caesar & Loretz GmbH

Address of manufacturer

Herderstr. 31, 40721 Hilden Germany

Location of manufacturing sites

Herderstr. 31, 40721 Hilden Germany

| Name of manufacturer | Karl-Josef Kost Alkohole & Produkte aus Alkohol KG |
| --- | --- |
| Address of manufacturer | Rauentalshöhe 4, 56073 Koblenz Germany |
| Location of manufacturing sites | Rauentalshöhe 4, 56073 Koblenz Germany |

Name of manufacturer

Karl-Josef Kost Alkohole & Produkte aus Alkohol KG

Address of manufacturer

Rauentalshöhe 4, 56073 Koblenz Germany

Location of manufacturing sites

Rauentalshöhe 4, 56073 Koblenz Germany

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

| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | ExxonMobil |
| Address of manufacturer | 4999 Scenic Highway, LA 70897 Baton Rouge, Louisiana United States |
| Location of manufacturing sites | 4999 Scenic Highway, LA 70897 Baton Rouge, Louisiana United States |

Active substance

Propan-2-ol

Name of manufacturer

ExxonMobil

Address of manufacturer

4999 Scenic Highway, LA 70897 Baton Rouge, Louisiana United States

Location of manufacturing sites

4999 Scenic Highway, LA 70897 Baton Rouge, Louisiana United States

| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | Shell Nederland Raffinaderij B.V. |
| Address of manufacturer | Vondelingenweg 601, Vodelingenenplaat, 3196 KK Rotterdam Netherlands |
| Location of manufacturing sites | Vondelingenweg 601, Vodelingenenplaat, 3196 KK Rotterdam Netherlands |

Active substance

Propan-2-ol

Name of manufacturer

Shell Nederland Raffinaderij B.V.

Address of manufacturer

Vondelingenweg 601, Vodelingenenplaat, 3196 KK Rotterdam Netherlands

Location of manufacturing sites

Vondelingenweg 601, Vodelingenenplaat, 3196 KK Rotterdam Netherlands

| Active substance | Propan-2-ol |
| --- | --- |
| Name of manufacturer | INEOS Solvents Germany GmbH |
| Address of manufacturer | Römerstrasse 733, 47443 Moers Germany |
| Location of manufacturing sites | Römerstrasse 733, 47443 Moers Germany
  Shamrockstraße 88, 44623 Herne Germany |

Active substance

Propan-2-ol

Name of manufacturer

INEOS Solvents Germany GmbH

Address of manufacturer

Römerstrasse 733, 47443 Moers Germany

Location of manufacturing sites

Römerstrasse 733, 47443 Moers Germany

Shamrockstraße 88, 44623 Herne 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 |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 62,7 | 70,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

62,7

70,0

2.2.   Type(s) of formulation

| Formulation(s) | Meta SPC 1: CL – Contact gel or Liquid
  Meta SPC 3: CL – Contact gel or Liquid
  Meta SPC 2: XX – Others: Ready-to-Use trigger spray |
| --- | --- |

Formulation(s)

Meta SPC 1: CL – Contact gel or Liquid

Meta SPC 3: CL – Contact gel or Liquid

Meta SPC 2: XX – Others: Ready-to-Use trigger spray

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) | PT01 – Human hygiene (Disinfectants) |
| --- | --- |

Product type(s)

PT01 – Human 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 |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 62,7 | 70,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

62,7

70,0

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

| Formulation(s) | Meta SPC 1: CL – Contact gel or Liquid |
| --- | --- |

Formulation(s)

Meta SPC 1: CL – Contact gel or Liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 1

| Hazard statements | Highly flammable liquid and vapour.
  Causes serious eye irritation.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | If medical advice is needed, have product container or label at hand.
  Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
  Keep container tightly closed.
  Avoid breathing vapours.
  Avoid breathing spray.
  Use only outdoors or in a well-ventilated area.
  Wear eye protection.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Call a POISON CENTER/doctor if you feel unwell.
  If eye irritation persists:Get medical advice.
  If eye irritation persists:Get medical attention.
  Store in a well-ventilated place.Keep cool.
  Store locked up.
  Dispose of contents to in accordance with local regulations.
  Dispose of container to in accordance with local regulations. |

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

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

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

Keep container tightly closed.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

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

Call a POISON CENTER/doctor if you feel unwell.

If eye irritation persists:Get medical advice.

If eye irritation persists:Get medical attention.

Store in a well-ventilated place.Keep cool.

Store locked up.

Dispose of contents to in accordance with local regulations.

Dispose of container to in accordance with local regulations.

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

4.1.   Use description

Table 1

Use # 1 – Use 1 – Contact Gel or Liquid – Hygienic handrub – Professional user

| Product type | PT01 – Human hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria (incl. Mycobacteria),
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: -
  Scientific name: Enveloped viruses
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  For professional use only. For use in private, public, healthcare and industrial areas and in areas for professional activities. |
| Application method(s) | Method: Direct application to both hands, rubbing
  Detailed description:
  - |
| Application rate(s) and frequency | Application Rate: 3 ml applied to one hand and complete surface of both hands are moistened and rubbed for 60 seconds per application.
  Dilution (%): -
  Number and timing of application:
  Up to 25 disinfections per day, 5 day(s) per week |
| Category(ies) of users | Professional |
| Pack sizes and packaging material | — | Bottle HD-PE: 0,1L – 2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP)) |

Product type

PT01 – Human hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: Bacteria (incl. Mycobacteria),

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Enveloped viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

For professional use only. For use in private, public, healthcare and industrial areas and in areas for professional activities.

Application method(s)

Method: Direct application to both hands, rubbing

Detailed description:

-

Application rate(s) and frequency

Application Rate: 3 ml applied to one hand and complete surface of both hands are moistened and rubbed for 60 seconds per application.

Dilution (%): -

Number and timing of application:

Up to 25 disinfections per day, 5 day(s) per week

Category(ies) of users

Professional

Pack sizes and packaging material

—

Bottle HD-PE: 0,1L – 2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP))

| — | Can HD-PE: 5L – 60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE) |
| --- | --- |

—

Can HD-PE: 5L – 60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE)

| — | Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE)) |
| --- | --- |

—

Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE))

| — | IBC container HD-PE: 1000L; (Screw caps (HD-PE) |
| --- | --- |

—

IBC container HD-PE: 1000L; (Screw caps (HD-PE)

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

5.1.   Instructions for use

| 1) | For professional use only. |
| --- | --- |

1)

For professional use only.

| 2) | Products must be shaken before use. |
| --- | --- |

2)

Products must be shaken before use.

| 3) | Only apply on dry and visibly clean hands. |
| --- | --- |

3)

Only apply on dry and visibly clean hands.

| 4) | For hand disinfection a ready-to-use gel or liquid (3 ml) is poured into the palms of one hand and the complete surface of both hands are moistened and rubbed for 60 seconds per application. |
| --- | --- |

4)

For hand disinfection a ready-to-use gel or liquid (3 ml) is poured into the palms of one hand and the complete surface of both hands are moistened and rubbed for 60 seconds per application.

5.2.   Risk mitigation measures

| 1) | Avoid contact with eyes. |
| --- | --- |

1)

Avoid contact with eyes.

| 2) | Keep out of reach of children and pets. |
| --- | --- |

2)

Keep out of reach of children and pets.

| 3) | Use only in well-ventilated areas. |
| --- | --- |

3)

Use only in well-ventilated areas.

| 4) | For refilling a funnel must be applied. |
| --- | --- |

4)

For refilling a funnel must be applied.

| 5) | The following personal risk mitigation measure can be considered for refilling procedure unless it can be replaced by technical and/or organisational measures: |
| --- | --- |

5)

The following personal risk mitigation measure can be considered for refilling procedure unless it can be replaced by technical and/or organisational measures:

The use of eye protection during refilling of the product is recommended.

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

| 1) | 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. |
| --- | --- |

1)

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.

| 2) | IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. |
| --- | --- |

2)

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

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

| 1) | Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations. |
| --- | --- |

1)

Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations.

| 2) | Do not let product enter drains. |
| --- | --- |

2)

Do not let product enter drains.

| 3) | Contact waste disposal services. |
| --- | --- |

3)

Contact waste disposal services.

| 4) | Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product. |
| --- | --- |

4)

Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product.

| 5) | Do not burn, or use a cutting torch on, the empty drum. Risk of explosion. |
| --- | --- |

5)

Do not burn, or use a cutting torch on, the empty drum. Risk of explosion.

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

| 1) | Store in a well-ventilated place. |
| --- | --- |

1)

Store in a well-ventilated place.

| 2) | Keep cool. |
| --- | --- |

2)

Keep cool.

| 3) | Keep container tightly closed. |
| --- | --- |

3)

Keep container tightly closed.

| 4) | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. |
| --- | --- |

4)

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

| 5) | Shelf-life: 24 months |
| --- | --- |

5)

Shelf-life: 24 months

6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.

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) | Wofasept AHA | Market area: EU |
| --- | --- | --- |
| | Otovita® Professional Handgel | Market area: EU |
| Authorisation number | EU-0027707-0001 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 62,7 |

Trade name(s)

Wofasept AHA

Market area: EU

Otovita® Professional Handgel

Market area: EU

Authorisation number

EU-0027707-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

62,7

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

| Trade name(s) | Budenat® Protect Hand D807 | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0027707-0002 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,0 |

Trade name(s)

Budenat® Protect Hand D807

Market area: EU

Authorisation number

EU-0027707-0002 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,0

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

| Trade name(s) | Handsteril OG | Market area: EU |
| --- | --- | --- |
| Disinfection for Hands OG | Market area: EU |
| 2-Propanol 70 % | Market area: EU |
| Isopropylalkohol Königseer Biozid | Market area: EU |
| Isogel Königseer Biozid Plus | Market area: EU |
| Isogel Königseer Biozid | Market area: EU |
| ISO 70 | Market area: EU |
| Brensolv K68 | Market area: EU |
| Isopropanol 70 Biocide | Market area: EU |
| Isopropanol 70 | Market area: EU |
| Hand- und Oberflächendesinfektion | Market area: EU |
| Authorisation number | EU-0027707-0003 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 70,0 |

Trade name(s)

Handsteril OG

Market area: EU

Disinfection for Hands OG

Market area: EU

2-Propanol 70 %

Market area: EU

Isopropylalkohol Königseer Biozid

Market area: EU

Isogel Königseer Biozid Plus

Market area: EU

Isogel Königseer Biozid

Market area: EU

ISO 70

Market area: EU

Brensolv K68

Market area: EU

Isopropanol 70 Biocide

Market area: EU

Isopropanol 70

Market area: EU

Hand- und Oberflächendesinfektion

Market area: EU

Authorisation number

EU-0027707-0003 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

70,0

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

| Trade name(s) | Handsteril OG blau | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0027707-0004 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 65,0 |

Trade name(s)

Handsteril OG blau

Market area: EU

Authorisation number

EU-0027707-0004 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

65,0

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

| Trade name(s) | Easysept | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0027707-0005 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,0 |

Trade name(s)

Easysept

Market area: EU

Authorisation number

EU-0027707-0005 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,0

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

| Trade name(s) | Witty-Lavalin D | Market area: EU |
| --- | --- | --- |
| proCura Spray PUR | Market area: EU |
| Orlin Suprades HD | Market area: EU |
| Esept | Market area: EU |
| Bio Tec Des HD | Market area: EU |
| Authorisation number | EU-0027707-0006 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 |

Trade name(s)

Witty-Lavalin D

Market area: EU

proCura Spray PUR

Market area: EU

Orlin Suprades HD

Market area: EU

Esept

Market area: EU

Bio Tec Des HD

Market area: EU

Authorisation number

EU-0027707-0006 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

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

| Trade name(s) | Curacid HD-sept | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0027707-0007 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 62,8 |

Trade name(s)

Curacid HD-sept

Market area: EU

Authorisation number

EU-0027707-0007 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

62,8

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

| Trade name(s) | Esept Gel | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0027707-0008 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,4 |

Trade name(s)

Esept Gel

Market area: EU

Authorisation number

EU-0027707-0008 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,4

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

| Trade name(s) | Mano Germs | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0027707-0009 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,0 |

Trade name(s)

Mano Germs

Market area: EU

Authorisation number

EU-0027707-0009 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,0

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

| Trade name(s) | Deogel Mani | Market area: EU |
| --- | --- | --- |
| Deovet | Market area: EU |
| Deogel Hands | Market area: EU |
| Deomed | Market area: EU |
| Dermigel profumato | Market area: EU |
| Authorisation number | EU-0027707-0010 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 70,0 |

Trade name(s)

Deogel Mani

Market area: EU

Deovet

Market area: EU

Deogel Hands

Market area: EU

Deomed

Market area: EU

Dermigel profumato

Market area: EU

Authorisation number

EU-0027707-0010 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

70,0

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

| Trade name(s) | Isogel | Market area: EU |
| --- | --- | --- |
| Vetgel | Market area: EU |
| Icfgel | Market area: EU |
| Skingel | Market area: EU |
| Sanigel | Market area: EU |
| Dermigel | Market area: EU |
| Gel mimani | Market area: EU |
| Authorisation number | EU-0027707-0011 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 70,0 |

Trade name(s)

Isogel

Market area: EU

Vetgel

Market area: EU

Icfgel

Market area: EU

Skingel

Market area: EU

Sanigel

Market area: EU

Dermigel

Market area: EU

Gel mimani

Market area: EU

Authorisation number

EU-0027707-0011 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

70,0

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

| Trade name(s) | Alcodet profumato | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0027707-0012 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 70,0 |

Trade name(s)

Alcodet profumato

Market area: EU

Authorisation number

EU-0027707-0012 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

70,0

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

| Trade name(s) | Handsan | Market area: EU |
| --- | --- | --- |
| Manisan | Market area: EU |
| Sanimed | Market area: EU |
| Authorisation number | EU-0027707-0013 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 70,0 |

Trade name(s)

Handsan

Market area: EU

Manisan

Market area: EU

Sanimed

Market area: EU

Authorisation number

EU-0027707-0013 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

70,0

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

| Trade name(s) | ELIGEL | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0027707-0014 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 70,0 |

Trade name(s)

ELIGEL

Market area: EU

Authorisation number

EU-0027707-0014 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

70,0

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

| Trade name(s) | ELIGEL Perfum | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0027707-0015 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 70,0 |

Trade name(s)

ELIGEL Perfum

Market area: EU

Authorisation number

EU-0027707-0015 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

70,0

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

| Trade name(s) | Desmila VSI | Market area: EU |
| --- | --- | --- |
| mobilomed Skinsoft Expert | Market area: EU |
| SiMa CleanTecMano | Market area: EU |
| Funny Hygienikum | Market area: EU |
| Authorisation number | EU-0027707-0016 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 62,8 |

Trade name(s)

Desmila VSI

Market area: EU

mobilomed Skinsoft Expert

Market area: EU

SiMa CleanTecMano

Market area: EU

Funny Hygienikum

Market area: EU

Authorisation number

EU-0027707-0016 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

62,8

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

| Trade name(s) | Desmila VSI C | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0027707-0017 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,0 |

Trade name(s)

Desmila VSI C

Market area: EU

Authorisation number

EU-0027707-0017 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,0

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

| Trade name(s) | Desmila LSI | Market area: EU |
| --- | --- | --- |
| mobilomed Skinsoft Professional | Market area: EU |
| Authorisation number | EU-0027707-0018 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 64,7 |

Trade name(s)

Desmila LSI

Market area: EU

mobilomed Skinsoft Professional

Market area: EU

Authorisation number

EU-0027707-0018 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

64,7

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

| Trade name(s) | Desmila LSI C | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0027707-0019 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 64,7 |

Trade name(s)

Desmila LSI C

Market area: EU

Authorisation number

EU-0027707-0019 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

64,7

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

| Trade name(s) | Desmila LSI pure | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0027707-0020 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 64,7 |

Trade name(s)

Desmila LSI pure

Market area: EU

Authorisation number

EU-0027707-0020 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

64,7

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

Product type(s)

PT04 – Food and feed area (Disinfectants)

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 |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 62,8 | 70,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

62,8

70,0

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

| Formulation(s) | Meta SPC 2: XX – Others: Ready-to-Use trigger spray |
| --- | --- |

Formulation(s)

Meta SPC 2: XX – Others: Ready-to-Use trigger spray

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 2

| Hazard statements | Highly flammable liquid and vapour.
  Causes serious eye irritation.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | If medical advice is needed, have product container or label at hand.
  Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
  Keep container tightly closed.
  Avoid breathing vapours.
  Avoid breathing spray.
  Use only outdoors or in a well-ventilated area.
  Wear eye protection.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Call a POISON CENTER/doctor if you feel unwell.
  If eye irritation persists:Get medical advice.
  If eye irritation persists:Get medical attention.
  Store in a well-ventilated place.Keep cool.
  Store locked up.
  Dispose of contents to in accordance with local regulations.
  Dispose of container to in accordance with local regulations. |

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

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

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

Keep container tightly closed.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

Wear eye protection.

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

Call a POISON CENTER/doctor if you feel unwell.

If eye irritation persists:Get medical advice.

If eye irritation persists:Get medical attention.

Store in a well-ventilated place.Keep cool.

Store locked up.

Dispose of contents to in accordance with local regulations.

Dispose of container to in accordance with local regulations.

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

4.1.   Use description

Table 2

Use # 1 – Use 1 – Liquid Spray – Small surface disinfection – Professional user

| 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 | Not relevant. |
| Target organism(s) (including development stage) | Scientific name: Bacteria (incl. Mycobacteria),
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  Disinfection of small non-porous surfaces, materials, equipment and furniture in private, public, healthcare, industrial areas and in areas for professional activities. |
| Application method(s) | Method: Spraying
  Detailed description:
  - |
| Application rate(s) and frequency | Application Rate: For surface disinfection a ready-to-use spray solution (20 ml/m2) is applied on surfaces at room temperature.
  Dilution (%): -
  Number and timing of application: | Application according to requirements, one application per use, 4 times per day. |

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

Not relevant.

Target organism(s) (including development stage)

Scientific name: Bacteria (incl. Mycobacteria),

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Field(s) of use

Indoor

Disinfection of small non-porous surfaces, materials, equipment and furniture in private, public, healthcare, industrial areas and in areas for professional activities.

Application method(s)

Method: Spraying

Detailed description:

-

Application rate(s) and frequency

Application Rate: For surface disinfection a ready-to-use spray solution (20 ml/m2) is applied on surfaces at room temperature.

Dilution (%): -

Number and timing of application:

Application according to requirements, one application per use, 4 times per day.

Small surface disinfection(other than healthcare):

| | Bactericidal and yeasticidal: contact time at least 1 min |
| --- | --- |

Bactericidal and yeasticidal: contact time at least 1 min

In healthcare area:

| | Bactericidal and yeasticidal: contact time at least 5 min |
| --- | --- |

Bactericidal and yeasticidal: contact time at least 5 min

Category(ies) of users

Professional

Pack sizes and packaging material

| — | Bottle HD-PE: 0,1L – 2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP)) |
| --- | --- |

—

Bottle HD-PE: 0,1L – 2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP))

| — | Can HD-PE: 5L – 60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE) |
| --- | --- |

—

Can HD-PE: 5L – 60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE)

| — | Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE)) |
| --- | --- |

—

Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE))

| — | IBC container HD-PE: 1000L; (Screw caps (HD-PE) |
| --- | --- |

—

IBC container HD-PE: 1000L; (Screw caps (HD-PE)

4.1.1.   Use-specific instructions for use

| 1) | Apply the ready-to-use product to the surface by spraying. Make sure to wet surfaces completely and wait for 1 minute (general surface disinfection) or 5 minutes (surfaces in healthcare area) |
| --- | --- |

1)

Apply the ready-to-use product to the surface by spraying. Make sure to wet surfaces completely and wait for 1 minute (general surface disinfection) or 5 minutes (surfaces in healthcare area)

| 2) | For use at room temperature. |
| --- | --- |

2)

For use at room temperature.

| 3) | Application according to requirements, one application per use, 4 times per day. |
| --- | --- |

3)

Application according to requirements, one application per use, 4 times per day.

4.1.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be considered for refilling procedure unless it can be replaced by technical and/or organisational measures:

The use of eye protection during refilling of the product is recommended.

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 3

Use # 2 – Use 2 – Liquid Spray – Disinfection for small food contact surfaces – Professional user

| Product type | PT04 – Food and feed area (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  Disinfection of small non-porous surfaces in food sector or food processing industries (including breweries, dairy industry and meat industry). |
| Application method(s) | Method: Spraying
  Detailed description:
  - |
| Application rate(s) and frequency | Application Rate: For surface disinfection a ready-to-use spray solution (20 ml/m2) is applied on surfaces at room temperature.
  Dilution (%): -
  Number and timing of application: | Application according to requirements, one application per use, 4 times per day. |

Product type

PT04 – Food and feed area (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: Bacteria

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Field(s) of use

Indoor

Disinfection of small non-porous surfaces in food sector or food processing industries (including breweries, dairy industry and meat industry).

Application method(s)

Method: Spraying

Detailed description:

-

Application rate(s) and frequency

Application Rate: For surface disinfection a ready-to-use spray solution (20 ml/m2) is applied on surfaces at room temperature.

Dilution (%): -

Number and timing of application:

Application according to requirements, one application per use, 4 times per day.

Small surface disinfection:

| | Bactericidal and yeasticidal: contact time at least 1 min |
| --- | --- |

Bactericidal and yeasticidal: contact time at least 1 min

In Breweries/meat industry:

| | Bactericidal and yeasticidal: contact time at least 5 min |
| --- | --- |

Bactericidal and yeasticidal: contact time at least 5 min

In dairy industry:

| | Bactericidal and yeasticidal: contact time at least 15 min |
| --- | --- |

Bactericidal and yeasticidal: contact time at least 15 min

Category(ies) of users

Professional

Pack sizes and packaging material

| — | Bottle HD-PE: 0,1L – 2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP)) |
| --- | --- |

—

Bottle HD-PE: 0,1L – 2,5L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP))

| — | Can HD-PE: 5L – 60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE) |
| --- | --- |

—

Can HD-PE: 5L – 60L; (Screw caps (PE/LDPE/HD-PE) or safety caps (HD-PE)

| — | Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE)) |
| --- | --- |

—

Drum HD-PE: 200L; (Plastic plug with venting system (HD-PE) or Plastic plug for tap (HD-PE) or plastic tap (HD-PE) or seal caps (HD-PE))

| — | IBC container HD-PE: 1000L;(Screw caps (HD-PE) |
| --- | --- |

—

IBC container HD-PE: 1000L;(Screw caps (HD-PE)

4.2.1.   Use-specific instructions for use

| 1) | Apply the ready-to-use product to the surface by spraying. Make sure to wet surfaces completely and wait for at least 1 min (general surface disinfection), 5 min (surface disinfection in breweries or meat industry) or at least 15 min (surface disinfection in dairy industry). |
| --- | --- |

1)

Apply the ready-to-use product to the surface by spraying. Make sure to wet surfaces completely and wait for at least 1 min (general surface disinfection), 5 min (surface disinfection in breweries or meat industry) or at least 15 min (surface disinfection in dairy industry).

| 2) | For use at room temperature. |
| --- | --- |

2)

For use at room temperature.

| 3) | Application according to requirements, one application per use, 4 times per day. |
| --- | --- |

3)

Application according to requirements, one application per use, 4 times per day.

4.2.2.   Use-specific risk mitigation measures

The following personal risk mitigation measure can be considered for disinfection of food processing machinery and refilling procedure unless it can be replaced by technical and/or organisational measures: The use of eye protection during handling of the product is recommended.

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

| 1) | Products must be shaken before use. |
| --- | --- |

1)

Products must be shaken before use.

| 2) | Do not apply more than 20 mL/m2. |
| --- | --- |

2)

Do not apply more than 20 mL/m2.

| 3) | Used wipes must be disposed in a closed container. |
| --- | --- |

3)

Used wipes must be disposed in a closed container.

5.2.   Risk mitigation measures

| 1) | Avoid contact with eyes. |
| --- | --- |

1)

Avoid contact with eyes.

| 2) | For refilling a funnel must be applied. |
| --- | --- |

2)

For refilling a funnel must be applied.

| 3) | The product must only be applied for disinfection of small surfaces. |
| --- | --- |

3)

The product must only be applied for disinfection of small surfaces.

| 4) | Keep out of reach of children and pets. |
| --- | --- |

4)

Keep out of reach of children and pets.

| 5) | Use only in well-ventilated areas. |
| --- | --- |

5)

Use only in well-ventilated areas.

| 6) | Keep children and pets away from rooms where disinfection is taking place. |
| --- | --- |

6)

Keep children and pets away from rooms where disinfection is taking place.

| 7) | Provide adequate ventilation before children and pets enter treated rooms. |
| --- | --- |

7)

Provide adequate ventilation before children and pets enter treated rooms.

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

| 1) | 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. |
| --- | --- |

1)

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.

| 2) | IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor. |
| --- | --- |

2)

IF INHALED: Move to fresh air and keep at rest in a position comfortable for breathing. Call a POISON CENTRE or a doctor.

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

| 1) | Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations. |
| --- | --- |

1)

Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations.

| 2) | Do not let product enter drains. |
| --- | --- |

2)

Do not let product enter drains.

| 3) | Contact waste disposal services. |
| --- | --- |

3)

Contact waste disposal services.

| 4) | Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product. |
| --- | --- |

4)

Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product.

| 5) | Do not burn, or use a cutting torch on, the empty drum. Risk of explosion. |
| --- | --- |

5)

Do not burn, or use a cutting torch on, the empty drum. Risk of explosion.

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

| 1) | Store in a well-ventilated place. |
| --- | --- |

1)

Store in a well-ventilated place.

| 2) | Keep cool. |
| --- | --- |

2)

Keep cool.

| 3) | Keep container tightly closed. |
| --- | --- |

3)

Keep container tightly closed.

| 4) | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. |
| --- | --- |

4)

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

| 5) | Shelf-life: 24 months |
| --- | --- |

5)

Shelf-life: 24 months

6.   OTHER INFORMATION

The product contains propan-2-ol (CAS No.: 67-63-0), for which a European reference value of 129,28 mg/m3 for the professional user was agreed and used for the risk assessment of the product.

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) | proCura Spray PUR | Market area: EU |
| --- | --- | --- |
| Witty-Express Ultra | Market area: EU |
| Witty-AQUA MEGA | Market area: EU |
| Anti-Germ DES ALC-IP | Market area: EU |
| BTS 6000 | Market area: EU |
| Bio Tec Des AX | Market area: EU |
| Authorisation number | EU-0027707-0021 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,1 |

Trade name(s)

proCura Spray PUR

Market area: EU

Witty-Express Ultra

Market area: EU

Witty-AQUA MEGA

Market area: EU

Anti-Germ DES ALC-IP

Market area: EU

BTS 6000

Market area: EU

Bio Tec Des AX

Market area: EU

Authorisation number

EU-0027707-0021 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,1

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

| Trade name(s) | Isopropanol 70 Biocide | Market area: EU |
| --- | --- | --- |
| Isopropanol 70 | Market area: EU |
| Isopropylalkohol Königseer Biozid | Market area: EU |
| Isogel Königseer Biozid Plus | Market area: EU |
| Gold | Market area: EU |
| Füllersteril PPP | Market area: EU |
| Isopropylalkohol 70 % Gew. | Market area: EU |
| Fast Germs | Market area: EU |
| BACTINYL IPA 70 % | Market area: EU |
| SAFE CLEANER SR | Market area: EU |
| Isopropylalkohol Königseer Flächen Biozid | Market area: EU |
| Isonet | Market area: EU |
| Isonet AL | Market area: EU |
| Sanificante Alcolico | Market area: EU |
| Isogerm | Market area: EU |
| Isogerm AL | Market area: EU |
| Isonet PU | Market area: EU |
| Alidet | Market area: EU |
| Sanocasa | Market area: EU |
| Frigosano | Market area: EU |
| Hygien Food | Market area: EU |
| Medicalsan | Market area: EU |
| Alcohol Sanitized | Market area: EU |
| Alkosan | Market area: EU |
| Biofarm | Market area: EU |
| Allkill | Market area: EU |
| DETERQUAT PRO SR | Market area: EU |
| Galtec Isoprop Bactericide | Market area: EU |
| Amphisol 70 | Market area: EU |
| AISW 100 | Market area: EU |
| Steril Spray PPP | Market area: EU |
| Hand- und Oberflächendesinfektion | Market area: EU |
| Authorisation number | EU-0027707-0022 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 70,0 |

Trade name(s)

Isopropanol 70 Biocide

Market area: EU

Isopropanol 70

Market area: EU

Isopropylalkohol Königseer Biozid

Market area: EU

Isogel Königseer Biozid Plus

Market area: EU

Gold

Market area: EU

Füllersteril PPP

Market area: EU

Isopropylalkohol 70 % Gew.

Market area: EU

Fast Germs

Market area: EU

BACTINYL IPA 70 %

Market area: EU

SAFE CLEANER SR

Market area: EU

Isopropylalkohol Königseer Flächen Biozid

Market area: EU

Isonet

Market area: EU

Isonet AL

Market area: EU

Sanificante Alcolico

Market area: EU

Isogerm

Market area: EU

Isogerm AL

Market area: EU

Isonet PU

Market area: EU

Alidet

Market area: EU

Sanocasa

Market area: EU

Frigosano

Market area: EU

Hygien Food

Market area: EU

Medicalsan

Market area: EU

Alcohol Sanitized

Market area: EU

Alkosan

Market area: EU

Biofarm

Market area: EU

Allkill

Market area: EU

DETERQUAT PRO SR

Market area: EU

Galtec Isoprop Bactericide

Market area: EU

Amphisol 70

Market area: EU

AISW 100

Market area: EU

Steril Spray PPP

Market area: EU

Hand- und Oberflächendesinfektion

Market area: EU

Authorisation number

EU-0027707-0022 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

70,0

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

| Trade name(s) | Budenat® Rapid Effect D 446 | Market area: EU |
| --- | --- | --- |
| IPA 300 | Market area: EU |
| Easydes IPA | Market area: EU |
| Sonet | Market area: EU |
| Sonet Forte | Market area: EU |
| Isosan Forte | Market area: EU |
| Germisan | Market area: EU |
| Sanivet | Market area: EU |
| Alidet Forte | Market area: EU |
| Germodet | Market area: EU |
| Isoclean | Market area: EU |
| Alcohol Sanitized Strong | Market area: EU |
| Alkosan Strong | Market area: EU |
| Isonet Strong | Market area: EU |
| Desmila HSI | Market area: EU |
| Vetasept pur | Market area: EU |
| Authorisation number | EU-0027707-0023 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,0 |

Trade name(s)

Budenat® Rapid Effect D 446

Market area: EU

IPA 300

Market area: EU

Easydes IPA

Market area: EU

Sonet

Market area: EU

Sonet Forte

Market area: EU

Isosan Forte

Market area: EU

Germisan

Market area: EU

Sanivet

Market area: EU

Alidet Forte

Market area: EU

Germodet

Market area: EU

Isoclean

Market area: EU

Alcohol Sanitized Strong

Market area: EU

Alkosan Strong

Market area: EU

Isonet Strong

Market area: EU

Desmila HSI

Market area: EU

Vetasept pur

Market area: EU

Authorisation number

EU-0027707-0023 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,0

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

| Trade name(s) | Isopropanol/Wasser 65/35 % | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0027707-0024 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 65,0 |

Trade name(s)

Isopropanol/Wasser 65/35 %

Market area: EU

Authorisation number

EU-0027707-0024 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

65,0

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

| Trade name(s) | Curacid Food Rapid | Market area: EU |
| --- | --- | --- |
| Dr Desi Küchendesinfektion | Market area: EU |
| Authorisation number | EU-0027707-0025 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 62,8 |

Trade name(s)

Curacid Food Rapid

Market area: EU

Dr Desi Küchendesinfektion

Market area: EU

Authorisation number

EU-0027707-0025 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

62,8

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

| Trade name(s) | Deogerm | Market area: EU |
| --- | --- | --- |
| Deosan | Market area: EU |
| Medicaldeo | Market area: EU |
| Deonet | Market area: EU |
| Deofloor | Market area: EU |
| Sanocasa Profumato | Market area: EU |
| Authorisation number | EU-0027707-0026 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,0 |

Trade name(s)

Deogerm

Market area: EU

Deosan

Market area: EU

Medicaldeo

Market area: EU

Deonet

Market area: EU

Deofloor

Market area: EU

Sanocasa Profumato

Market area: EU

Authorisation number

EU-0027707-0026 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,0

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

| Trade name(s) | Desmila HSI C | Market area: EU |
| --- | --- | --- |
| Vetasept Lemon | Market area: EU |
| Authorisation number | EU-0027707-0027 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,0 |

Trade name(s)

Desmila HSI C

Market area: EU

Vetasept Lemon

Market area: EU

Authorisation number

EU-0027707-0027 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,0

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

| Trade name(s) | Desmila HSI D | Market area: EU |
| --- | --- | --- |
| Vetasept Fresh | Market area: EU |
| Authorisation number | EU-0027707-0028 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,0 |

Trade name(s)

Desmila HSI D

Market area: EU

Vetasept Fresh

Market area: EU

Authorisation number

EU-0027707-0028 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,0

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

| Trade name(s) | Desmila HSI P | Market area: EU |
| --- | --- | --- |
| Vetasept Pfirsich | Market area: EU |
| Authorisation number | EU-0027707-0029 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,0 |

Trade name(s)

Desmila HSI P

Market area: EU

Vetasept Pfirsich

Market area: EU

Authorisation number

EU-0027707-0029 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,0

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

| Trade name(s) | Desmila AFI | Market area: EU |
| --- | --- | --- |
| Hygienic I | Market area: EU |
| Authorisation number | EU-0027707-0030 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 64,7 |

Trade name(s)

Desmila AFI

Market area: EU

Hygienic I

Market area: EU

Authorisation number

EU-0027707-0030 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

64,7

META SPC 3

1.   META SPC 3 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 3 identifier

| Identifier | Meta SPC 3 |
| --- | --- |

Identifier

Meta SPC 3

1.2.   Suffix to the authorisation number

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

Number

1-3

1.3.   Product type(s)

| Product type(s) | PT01 – Human hygiene (Disinfectants) |
| --- | --- |

Product type(s)

PT01 – Human hygiene (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 |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 62,7 | 70,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

Propan-2-ol

Active Substance

67-63-0

200-661-7

62,7

70,0

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

| Formulation(s) | Meta SPC 3: CL – Contact gel or Liquid |
| --- | --- |

Formulation(s)

Meta SPC 3: CL – Contact gel or Liquid

3.   HAZARD AND PRECAUTIONARY STATEMENTS OF THE META SPC 3

| Hazard statements | Highly flammable liquid and vapour.
  Causes serious eye irritation.
  May cause drowsiness or dizziness.
  Repeated exposure may cause skin dryness or cracking. |
| --- | --- |
| Precautionary statements | If medical advice is needed, have product container or label at hand.
  Keep out of reach of children.
  Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. – No smoking.
  Keep container tightly closed.
  Avoid breathing vapours.
  Avoid breathing spray.
  Use only outdoors or in a well-ventilated area.
  IF IN EYES:Rinse cautiously with water for several minutes.Remove contact lenses, if present and easy to do. Continue rinsing.
  Call a POISON CENTER/doctor if you feel unwell.
  If eye irritation persists:Get medical advice.
  If eye irritation persists:Get medical attention.
  Store in a well-ventilated place.Keep cool.
  Store locked up.
  Dispose of contents to in accordance with local regulations.
  Dispose of container to in accordance with local regulations. |

Hazard statements

Highly flammable liquid and vapour.

Causes serious eye irritation.

May cause drowsiness or dizziness.

Repeated exposure may cause skin dryness or cracking.

Precautionary statements

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

Keep out of reach of children.

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

Keep container tightly closed.

Avoid breathing vapours.

Avoid breathing spray.

Use only outdoors or in a well-ventilated area.

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

Call a POISON CENTER/doctor if you feel unwell.

If eye irritation persists:Get medical advice.

If eye irritation persists:Get medical attention.

Store in a well-ventilated place.Keep cool.

Store locked up.

Dispose of contents to in accordance with local regulations.

Dispose of container to in accordance with local regulations.

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

4.1.   Use description

Table 4

Use # 1 – Use 1 – Contact Gel or Liquid – Hygienic handrub – Non-professional user

| Product type | PT01 – Human hygiene (Disinfectants) |
| --- | --- |
| Where relevant, an exact description of the authorised use | Not relevant |
| Target organism(s) (including development stage) | Scientific name: Bacteria (incl. Mycobacteria),
  Common name: -
  Development stage: -
  Scientific name: Yeast
  Common name: -
  Development stage: -
  Scientific name: Enveloped viruses
  Common name: -
  Development stage: - |
| Field(s) of use | Indoor
  For use in private and public areas. |
| Application method(s) | Method: Direct application to both hands, rubbing
  Detailed description:
  - |
| Application rate(s) and frequency | Application Rate: 3 ml applied to one hand and complete surface of both hands are moistened and rubbed for 60 seconds per application.
  Dilution (%): -
  Number and timing of application:
  Up to 5 disinfections per day, 5 day(s) per week |
| Category(ies) of users | General public (non-professional) |
| Pack sizes and packaging material | Bottle HD-PE: 0,1L – 1,0L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP)) |

Product type

PT01 – Human hygiene (Disinfectants)

Where relevant, an exact description of the authorised use

Not relevant

Target organism(s) (including development stage)

Scientific name: Bacteria (incl. Mycobacteria),

Common name: -

Development stage: -

Scientific name: Yeast

Common name: -

Development stage: -

Scientific name: Enveloped viruses

Common name: -

Development stage: -

Field(s) of use

Indoor

For use in private and public areas.

Application method(s)

Method: Direct application to both hands, rubbing

Detailed description:

-

Application rate(s) and frequency

Application Rate: 3 ml applied to one hand and complete surface of both hands are moistened and rubbed for 60 seconds per application.

Dilution (%): -

Number and timing of application:

Up to 5 disinfections per day, 5 day(s) per week

Category(ies) of users

General public (non-professional)

Pack sizes and packaging material

Bottle HD-PE: 0,1L – 1,0L; (Screw caps (HD-PE) or caps (PP) or pump caps (PP) or trigger spray caps (PP) or safety caps (PP))

4.1.1.   Use-specific instructions for use

See general directions for use.

4.1.2.   Use-specific risk mitigation measures

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

See general directions for use.

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

5.1.   Instructions for use

| 1) | Comply with the instructions for use. |
| --- | --- |

1)

Comply with the instructions for use.

| 2) | Products must be shaken before use. |
| --- | --- |

2)

Products must be shaken before use.

| 3) | Only apply on dry and visibly clean hands. |
| --- | --- |

3)

Only apply on dry and visibly clean hands.

| 4) | For hand disinfection a ready-to-use gel or liquid (3 ml) is poured into the palms of one hand and the complete surface of both hands are moistened and rubbed for 60 seconds per application. |
| --- | --- |

4)

For hand disinfection a ready-to-use gel or liquid (3 ml) is poured into the palms of one hand and the complete surface of both hands are moistened and rubbed for 60 seconds per application.

| 5) | The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label:






  — | Trigger spray: Apply 3 or 4 spray strokes (depending on the trigger spray cap) |
| --- | --- | --- |

5)

The authorisation holder has to specify the typical application rate in a simple, easily understandable form on the label:

—

Trigger spray: Apply 3 or 4 spray strokes (depending on the trigger spray cap)

| — | Pump spray: Apply 3 pump strokes |
| --- | --- |

—

Pump spray: Apply 3 pump strokes

| — | Bottle: Visual observation |
| --- | --- |

—

Bottle: Visual observation

5.2.   Risk mitigation measures

| 1) | Avoid contact with eyes. |
| --- | --- |

1)

Avoid contact with eyes.

| 2) | Use by children only under supervision of an adult. |
| --- | --- |

2)

Use by children only under supervision of an adult.

| 3) | Use only in well-ventilated areas. |
| --- | --- |

3)

Use only in well-ventilated areas.

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

| 1) | If medical advice is needed, have product container or label at hand. |
| --- | --- |

1)

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

| 2) | IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do. Continue rinsing for five minutes. |
| --- | --- |

2)

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

| 3) | Call a POISON CENTER or doctor if you feel unwell. |
| --- | --- |

3)

Call a POISON CENTER or doctor if you feel unwell.

| 4) | If eye irritation persists: Get medical advice/attention. |
| --- | --- |

4)

If eye irritation persists: Get medical advice/attention.

| 5) | IF INHALED OR SWALLOWED: If symptoms occur call a POISON CENTRE or a doctor. |
| --- | --- |

5)

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

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

| 1) | Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations. |
| --- | --- |

1)

Product: Disposal together with normal waste is not allowed. Special disposal required according to local regulations.

| 2) | Do not let product enter drains. |
| --- | --- |

2)

Do not let product enter drains.

| 3) | Contact waste disposal services. |
| --- | --- |

3)

Contact waste disposal services.

| 4) | Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product. |
| --- | --- |

4)

Contaminated packaging: Empty contaminated packaging thoroughly. They can be recycled after thorough and proper cleaning. Packaging that cannot be cleaned are to be disposed of in the same manner as the product.

| 5) | Do not burn, or use a cutting torch on, the empty drum. Risk of explosion. |
| --- | --- |

5)

Do not burn, or use a cutting torch on, the empty drum. Risk of explosion.

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

| 1) | Store in a well-ventilated place. |
| --- | --- |

1)

Store in a well-ventilated place.

| 2) | Keep cool. |
| --- | --- |

2)

Keep cool.

| 3) | Keep container tightly closed. |
| --- | --- |

3)

Keep container tightly closed.

| 4) | Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. |
| --- | --- |

4)

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

| 5) | Keep out of reach of children and pets. |
| --- | --- |

5)

Keep out of reach of children and pets.

| 6) | Shelf-life: 24 months |
| --- | --- |

6)

Shelf-life: 24 months

6.   OTHER INFORMATION

-

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) | Frend Hand Sanitiser Gel | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0027707-0031 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 65,3 |

Trade name(s)

Frend Hand Sanitiser Gel

Market area: EU

Authorisation number

EU-0027707-0031 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

65,3

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

| Trade name(s) | Biogat H-Des | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0027707-0032 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 70,0 |

Trade name(s)

Biogat H-Des

Market area: EU

Authorisation number

EU-0027707-0032 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

70,0

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

| Trade name(s) | Neo-Amisept | Market area: EU |
| --- | --- | --- |
| Authorisation number | EU-0027707-0033 1-3 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| Propan-2-ol | | Active Substance | 67-63-0 | 200-661-7 | 63,0 |

Trade name(s)

Neo-Amisept

Market area: EU

Authorisation number

EU-0027707-0033 1-3

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Propan-2-ol

Active Substance

67-63-0

200-661-7

63,0

---

(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.

(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.

---

| 17.11.2022 | EN | Official Journal of the European Union | L 297/33 |
| --- | --- | --- | --- |

17.11.2022

EN

Official Journal of the European Union

L 297/33

---

COMMISSION IMPLEMENTING REGULATION (EU) 2022/2253

of 14 November 2022

granting a Union authorisation for the biocidal product family ‘Colgate-Palmolive Lactic acid PT 2’ 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 29 January 2019, Colgate Palmolive Sp. Z.o.o 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 ‘Colgate-Palmolive_Lactic acid_PT 2’ of product-type 2, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-HK051319-37 in the Register for Biocidal Products. |
| --- | --- |

(1)

On 29 January 2019, Colgate Palmolive Sp. Z.o.o 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 ‘Colgate-Palmolive_Lactic acid_PT 2’ of product-type 2, as described in Annex V to that Regulation, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-HK051319-37 in the Register for Biocidal Products.

| (2) | ‘Colgate-Palmolive Lactic acid PT 2’ 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 2. |
| --- | --- |

(2)

‘Colgate-Palmolive Lactic acid PT 2’ 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 2.

| (3) | On 25 August 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency. |
| --- | --- |

(3)

On 25 August 2021, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, an assessment report and the conclusions of its evaluation to the Agency.

| (4) | On 23 March 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Colgate-Palmolive Lactic acid PT 2’ and the final assessment report on the biocidal product family, in accordance with Article 44(3) of Regulation (EU) No 528/2012. |
| --- | --- |

(4)

On 23 March 2022, the Agency submitted to the Commission its opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘Colgate-Palmolive Lactic acid PT 2’ 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 ‘Colgate Palmolive Lactic acid PT 2’ 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 ‘Colgate Palmolive Lactic acid PT 2’ 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 12 April 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 12 April 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 ‘Colgate-Palmolive Lactic acid PT 2’. |
| --- | --- |

(7)

The Commission concurs with the opinion of the Agency and considers it therefore appropriate to grant a Union authorisation for ‘Colgate-Palmolive Lactic acid PT 2’.

| (8) | In its opinion, the Agency recommends that the authorisation holder conducts a differential scanning calorimetry test for representative products of all meta-SPCs of ‘Colgate-Palmolive Lactic acid PT 2’ as a condition in the authorisation. That test should confirm that representative products of those meta-SPCs are not to be classified as self-reactive mixture. The Commission agrees with that recommendation and considers that the submission of the results of that test should be a condition relating to the making available on the market and use of the biocidal product family ‘Colgate Palmolive Lactic acid PT 2’ in all meta SPCs pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of that Regulation based on existing data. |
| --- | --- |

(8)

In its opinion, the Agency recommends that the authorisation holder conducts a differential scanning calorimetry test for representative products of all meta-SPCs of ‘Colgate-Palmolive Lactic acid PT 2’ as a condition in the authorisation. That test should confirm that representative products of those meta-SPCs are not to be classified as self-reactive mixture. The Commission agrees with that recommendation and considers that the submission of the results of that test should be a condition relating to the making available on the market and use of the biocidal product family ‘Colgate Palmolive Lactic acid PT 2’ in all meta SPCs pursuant to Article 22(1) of Regulation (EU) No 528/2012. The Commission also considers that the fact that data is to be provided after the authorisation is granted does not affect the conclusion on the fulfilment of the condition under Article 19(1), point (d), of that Regulation based on existing data.

| (9) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products, |
| --- | --- |

(9)

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-0028421-0000 is hereby granted to Colgate Palmolive Sp. Z.o.o for the making available on the market and use of the biocidal product family ‘Colgate-Palmolive Lactic acid PT 2’ subject to compliance with the terms and conditions set out in Annex I and in accordance with the summary of the biocidal product characteristics set out in Annex II.

The Union authorisation is valid from 5 December 2022 to 30 November 2032.

Article 2

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

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

Done at Brussels, 14 November 2022.

For the Commission

The President

Ursula VON DER LEYEN

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

1

(2)  ECHA opinion of 2 March 2022 on the Union authorisation of ‘Colgate-Palmolive Lactic acid PT2’ (ECHA/BPC/317/2022), https://echa.europa.eu/bpc-opinions-on-union-authorisation

2

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ANNEX I

TERMS AND CONDITIONS (EU-0028421-0000)

The authorisation holder shall conduct a differential scanning calorimetry test for representative products of all meta-SPCs of ‘Colgate-Palmolive_Lactic acid_PT 2’. The test shall be conducted in accordance with section 1.6.2 of the Guidance on the Biocidal Products Regulation Volume I: Identity of the active substance/physico-chemical properties/analytical methodology – Information Requirements, Evaluation and Assessment (ECHA, March 2022) (1) in order to confirm that the representative products of those meta-SPCs are not to be classified as self-reactive mixture.

By 5 June 2023 the authorisation holder shall submit the results of the test to the Agency.

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(1)  https://echa.europa.eu/documents/10162/23036412/bpr_guidance_vol_i_parts_abc_en.pdf/31b245e5-52c2-f0c7-04db-8988683cbc4b

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ANNEX II

Summary of product characteristics for a biocidal product family

COLGATE-PALMOLIVE_LACTIC ACID_PT2

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

Authorisation number: EU-0028421-0000

R4BP asset number: EU-0028421-0000

PART I

FIRST INFORMATION LEVEL

1.   ADMINISTRATIVE INFORMATION

1.1.   Family name

| Name | COLGATE-PALMOLIVE_LACTIC ACID_PT2 |
| --- | --- |

Name

COLGATE-PALMOLIVE_LACTIC ACID_PT2

1.2.   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)

1.3.   Authorisation holder

| Name and address of the authorisation holder | Name | Colgate-Palmolive (Poland) Sp. Z.o.o |
| --- | --- | --- |
| Address | Wybrzeże Gdyńskie 6D, 01-531 Warszawa Poland |
| Authorisation number | EU-0028421-0000 |
| R4BP asset number | EU-0028421-0000 |
| Date of the authorisation | 5 December 2022 |
| Expiry date of the authorisation | 30 November 2032 |

Name and address of the authorisation holder

Name

Colgate-Palmolive (Poland) Sp. Z.o.o

Address

Wybrzeże Gdyńskie 6D, 01-531 Warszawa Poland

Authorisation number

EU-0028421-0000

R4BP asset number

EU-0028421-0000

Date of the authorisation

5 December 2022

Expiry date of the authorisation

30 November 2032

1.4.   Manufacturer(s) of the biocidal products

| Name of manufacturer | Colgate-Palmolive Industrial S.A.S |
| --- | --- |
| Address of manufacturer | 60 Avenue du Vermandois, 60200 Compiègne France |
| Location of manufacturing sites | 60 Avenue du Vermandois, 60200 Compiègne France |

Name of manufacturer

Colgate-Palmolive Industrial S.A.S

Address of manufacturer

60 Avenue du Vermandois, 60200 Compiègne France

Location of manufacturing sites

60 Avenue du Vermandois, 60200 Compiègne France

| Name of manufacturer | Colgate Palmolive (Hellas) SAIC |
| --- | --- |
| Address of manufacturer | 89 Athinon, 18541 Piraeus Greece |
| Location of manufacturing sites | 89 Athinon, 18541 Piraeus Greece |

Name of manufacturer

Colgate Palmolive (Hellas) SAIC

Address of manufacturer

89 Athinon, 18541 Piraeus Greece

Location of manufacturing sites

89 Athinon, 18541 Piraeus Greece

| Name of manufacturer | Colgate Palmolive Srl Italy |
| --- | --- |
| Address of manufacturer | Viale Palmolive, 18, 00042 Anzio Italy |
| Location of manufacturing sites | Viale Palmolive, 18, 00042 Anzio Italy |

Name of manufacturer

Colgate Palmolive Srl Italy

Address of manufacturer

Viale Palmolive, 18, 00042 Anzio Italy

Location of manufacturing sites

Viale Palmolive, 18, 00042 Anzio Italy

| Name of manufacturer | EURO WIPES |
| --- | --- |
| Address of manufacturer | 2 Rue du Grand Champ, 28400 Nogent-le-Rotrou France |
| Location of manufacturing sites | 2 Rue du Grand Champ, 28400 Nogent-le-Rotrou France |

Name of manufacturer

EURO WIPES

Address of manufacturer

2 Rue du Grand Champ, 28400 Nogent-le-Rotrou France

Location of manufacturing sites

2 Rue du Grand Champ, 28400 Nogent-le-Rotrou France

| Name of manufacturer | Hangzhou Guoguang Touring Commodity Co., Ltd |
| --- | --- |
| Address of manufacturer | No 8 Yunshun Road, – Jingshan Town, Yuhang District, Hangzhou, Zhejiang Province China |
| Location of manufacturing sites | No 8 Yunshun Road, – Jingshan Town, Yuhang District, Hangzhou, Zhejiang Province China |

Name of manufacturer

Hangzhou Guoguang Touring Commodity Co., Ltd

Address of manufacturer

No 8 Yunshun Road, – Jingshan Town, Yuhang District, Hangzhou, Zhejiang Province China

Location of manufacturing sites

No 8 Yunshun Road, – Jingshan Town, Yuhang District, Hangzhou, Zhejiang Province China

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, NL-4200 AA Gorinchem Netherlands |
| Location of manufacturing sites | Arkelsedijk 46, NL-4200 AA Gorinchem Netherlands |

Active substance

L-(+)-lactic acid

Name of manufacturer

Purac Biochem bv

Address of manufacturer

Arkelsedijk 46, NL-4200 AA Gorinchem Netherlands

Location of manufacturing sites

Arkelsedijk 46, NL-4200 AA Gorinchem Netherlands

| Active substance | L-(+)-lactic acid |
| --- | --- |
| Name of manufacturer | Purac Bioquimica SA |
| Address of manufacturer | Gran Vial 19-25, 08160 Montmeló (Barcelona) Spain |
| Location of manufacturing sites | Gran Vial 19-25, 08160 Montmeló (Barcelona) Spain |

Active substance

L-(+)-lactic acid

Name of manufacturer

Purac Bioquimica SA

Address of manufacturer

Gran Vial 19-25, 08160 Montmeló (Barcelona) Spain

Location of manufacturing sites

Gran Vial 19-25, 08160 Montmeló (Barcelona) Spain

| Active substance | L-(+)-lactic acid |
| --- | --- |
| Name of manufacturer | Jungbunzlauer International S.A. |
| Address of manufacturer | St. Alban-Vorstadt 90 – P.O. Box, CH-4002 Basel Switzerland |
| Location of manufacturing sites | Jungbunzlauer S.A. – Z.I. et Portuaire B.P. 32., FR-67390 Marckolsheim France |

Active substance

L-(+)-lactic acid

Name of manufacturer

Jungbunzlauer International S.A.

Address of manufacturer

St. Alban-Vorstadt 90 – P.O. Box, CH-4002 Basel Switzerland

Location of manufacturing sites

Jungbunzlauer S.A. – 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 | 1,57 | 4,19 |
| Decan-1-ol, ethoxylated (> 2.5 moles EO) | | Non-active substance | 26183-52-8 | 500-046-6 | 0,0 | 3,0 |
| Propan-2-ol | | Non-active substance | 67-63-0 | 200-661-7 | 0,0 | 0,1 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

1,57

4,19

Decan-1-ol, ethoxylated (> 2.5 moles EO)

Non-active substance

26183-52-8

500-046-6

0,0

3,0

Propan-2-ol

Non-active substance

67-63-0

200-661-7

0,0

0,1

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 1-2 PT2 BDC |
| --- | --- |

Identifier

META SPC 1-2 PT2 BDC

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 |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 1,57 | 2,93 |
| Decan-1-ol, ethoxylated (> 2.5 moles EO) | | Non-active substance | 26183-52-8 | 500-046-6 | 3,0 | 3,0 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

1,57

2,93

Decan-1-ol, ethoxylated (> 2.5 moles EO)

Non-active substance

26183-52-8

500-046-6

3,0

3,0

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 | If medical advice is needed, have product container or label at hand.
  Keep out of reach of children.
  Read carefully and follow all instructions.
  Wash thoroughly after handling.
  IF ON SKIN:Wash with plenty of water.
  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/doctor/....
  Specific treatment (see on this label).
  If skin irritation occurs:Get medical advice.
  Take off contaminated clothing.And wash it before reuse. |

Hazard statements

Causes skin irritation.

Causes serious eye damage.

Precautionary statements

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

Keep out of reach of children.

Read carefully and follow all instructions.

Wash thoroughly after handling.

IF ON SKIN:Wash with plenty of water.

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/doctor/....

Specific treatment (see on this label).

If skin irritation occurs:Get medical advice.

Take off contaminated clothing.And wash it before reuse.

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

4.1.   Use description

Table 1

Use # 1 – Hard surface disinfection domestic surfaces

| 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: Bacteria
  Common name: Bacteria
  Development stage: |
| Field(s) of use | Indoor
  Household – Bathroom porous and non-porous hard surfaces other than kitchen. |
| Application method(s) | Method: Manual application
  Detailed description:
  Pour the neat product on sponge, spread on the surface to disinfect (without pre-cleaning).
  Rinsing is required. |
| Application rate(s) and frequency | Application Rate: 18 g of product per m2 on a sponge.
  Dilution (%): -
  Number and timing of application:
  Ready to use.
  Contact time: 15 minutes
  Room temperature
  Frequency: Daily |
| Category(ies) of users | General public (non-professional) |
| Pack sizes and packaging material | PET bottle 650, 750, 1000, 1250, 1300, 1500 and PE bottle 2000 ml |

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: Bacteria

Common name: Bacteria

Development stage:

Field(s) of use

Indoor

Household – Bathroom porous and non-porous hard surfaces other than kitchen.

Application method(s)

Method: Manual application

Detailed description:

Pour the neat product on sponge, spread on the surface to disinfect (without pre-cleaning).

Rinsing is required.

Application rate(s) and frequency

Application Rate: 18 g of product per m2 on a sponge.

Dilution (%): -

Number and timing of application:

Ready to use.

Contact time: 15 minutes

Room temperature

Frequency: Daily

Category(ies) of users

General public (non-professional)

Pack sizes and packaging material

PET bottle 650, 750, 1000, 1250, 1300, 1500 and PE bottle 2000 ml

4.1.1.   Use-specific instructions for use

| — | 1/2 cap of product on a sponge corresponding to 18 g of product per m2 |
| --- | --- |

—

1/2 cap of product on a sponge corresponding to 18 g of product per m2

4.1.2.   Use-specific risk mitigation measures

-

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

-

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

-

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

-

4.2.   Use description

Table 2

Use # 2 – Toilet bowl surfaces disinfection

| 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: Bacteria
  Common name: Bacteria
  Development stage: |
| Field(s) of use | Indoor
  Household toilets – Disinfection for Toilets bowls surfaces – Porous and non-porous hard surface disinfection |
| Application method(s) | Method: Manual application
  Detailed description:
  Pour the neat product on sponge, spread on the surface to disinfect (without pre-cleaning).
  Rinsing is required. |
| Application rate(s) and frequency | Application Rate: 18 g of product per m2 on a sponge
  Dilution (%): -
  Number and timing of application:
  Ready to use.
  Contact time: 15 minutes
  Room temperature
  Frequency: daily |
| Category(ies) of users | General public (non-professional) |
| Pack sizes and packaging material | PET bottle 650, 750, 1000, 1250, 1300, 1500 and PE bottle 2000 mL |

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: Bacteria

Common name: Bacteria

Development stage:

Field(s) of use

Indoor

Household toilets – Disinfection for Toilets bowls surfaces – Porous and non-porous hard surface disinfection

Application method(s)

Method: Manual application

Detailed description:

Pour the neat product on sponge, spread on the surface to disinfect (without pre-cleaning).

Rinsing is required.

Application rate(s) and frequency

Application Rate: 18 g of product per m2 on a sponge

Dilution (%): -

Number and timing of application:

Ready to use.

Contact time: 15 minutes

Room temperature

Frequency: daily

Category(ies) of users

General public (non-professional)

Pack sizes and packaging material

PET bottle 650, 750, 1000, 1250, 1300, 1500 and PE bottle 2000 mL

4.2.1.   Use-specific instructions for use

| — | 1/2 cap of product on a sponge corresponding to 18 g of product per m2. |
| --- | --- |

—

1/2 cap of product on a sponge corresponding to 18 g of product per m2.

4.2.2.   Use-specific risk mitigation measures

-

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

-

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

-

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

-

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

5.1.   Instructions for use

| — | Comply with the instruction of use. |
| --- | --- |

—

Comply with the instruction of use.

| — | Inform the registration holder if the treatment is ineffective. |
| --- | --- |

—

Inform the registration holder if the treatment is ineffective.

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

—

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

| — | Let the surface dry after rinsing |
| --- | --- |

—

Let the surface dry after rinsing

| — | Clean the cap after dosing |
| --- | --- |

—

Clean the cap after dosing

5.2.   Risk mitigation measures

| — | Wash hands after use |
| --- | --- |

—

Wash hands after use

| — | Avoid contact with eyes. |
| --- | --- |

—

Avoid contact with eyes.

| — | Avoid splashes and spills during pouring. |
| --- | --- |

—

Avoid splashes and spills during pouring.

| — | Wash thoroughly the sponge with a great amount of water. |
| --- | --- |

—

Wash thoroughly the sponge with a great amount of water.

| — | Do not touch the surface until the surface is rinsed and dry. |
| --- | --- |

—

Do not touch the surface until the surface is rinsed and dry.

| — | Children and pets should not be present during disinfection and until the surface is rinsed and dry. |
| --- | --- |

—

Children and pets should not be present during disinfection and until the surface is rinsed and dry.

| — | The bottles sized above 1L and up to 2L must be adapted with a handle. |
| --- | --- |

—

The bottles sized above 1L and up to 2L must be adapted with a handle.

| — | The packaging must be adapted with a child proof closure. |
| --- | --- |

—

The packaging must be adapted with a child proof closure.

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

| — | IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice. |
| --- | --- |

—

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

| — | IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.
  Call 112/ambulance for medical assistance.
  Information to Healthcare personnel/doctor:
  The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid |
| --- | --- |

—

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

Call 112/ambulance for medical assistance.

Information to Healthcare personnel/doctor:

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

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

—

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

| — | IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. Seek medical advice immediately if symptoms occur and/or large quantities have been inhaled.
  If medical advice is needed, have product container or label at hand |
| --- | --- |

—

IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. Seek medical advice immediately if symptoms occur and/or large quantities have been inhaled.

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

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

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

—

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

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

—

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

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

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

—

Shelf life: 2 years

| — | Do not store above 40 °C |
| --- | --- |

—

Do not store above 40 °C

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

—

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

| — | Protect from light |
| --- | --- |

—

Protect from light

6.   OTHER INFORMATION

-

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) | B029-1342-0015 | Market area: EU |
| --- | --- | --- |
| Ajax APC Antibacterial Blue @ 1,3 % LA (ref B029-1342-0015) | Market area: EU |
| Ajax Antibakteriell | Market area: EU |
| Ajax Απολυμαντικό Χωρίς Χλώριο Clean Fresh; Ajax Απολυμαντικό Clean Fresh | Market area: EU |
| Ajax Optimal 7 Antibactérien Fraîcheur Océan; Ajax Multi-surfaces Antibactérien Fraîcheur Océan; Ajax Antibacterial Ocean Fresh | Market area: EU |
| Ajax Antibakteriell | Market area: EU |
| Ajax Απολυμαντικό Χωρίς Χλώριο Clean Fresh; Ajax Απολυμαντικό Clean Fresh | Market area: EU |
| Ajax Disinfettante Clean Fresh | Market area: EU |
| Ajax Antibacteriano Ultra Frescura | Market area: EU |
| Ajax Antibacteriano | Market area: EU |
| Ajax Antibacterial Blue | Market area: EU |
| Ajax Désinfectant/Ajax Desinfecterend; Ajax Désinfectant Clean Fresh/Ajax Desinfecterend Clean Fresh; Ajax Désinfectant Fraîcheur Océan/Ajax Desinfecterend Oceaan Frisheid; Ajax Antibactérien/Ajax Antibacterieel | Market area: EU |
| Ajax Desinfectant; Ajax Desinfectant Clean Fresh; Ajax Desinfectant Oceaan Frisheid; Ajax Antibacterieel | Market area: EU |
| Authorisation number | EU-0028421-0001 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 1,57 |
| Decan-1-ol, ethoxylated (> 2.5 moles EO) | | Non-active substance | 26183-52-8 | 500-046-6 | 3,0 |

Trade name(s)

B029-1342-0015

Market area: EU

Ajax APC Antibacterial Blue @ 1,3 % LA (ref B029-1342-0015)

Market area: EU

Ajax Antibakteriell

Market area: EU

Ajax Απολυμαντικό Χωρίς Χλώριο Clean Fresh; Ajax Απολυμαντικό Clean Fresh

Market area: EU

Ajax Optimal 7 Antibactérien Fraîcheur Océan; Ajax Multi-surfaces Antibactérien Fraîcheur Océan; Ajax Antibacterial Ocean Fresh

Market area: EU

Ajax Antibakteriell

Market area: EU

Ajax Απολυμαντικό Χωρίς Χλώριο Clean Fresh; Ajax Απολυμαντικό Clean Fresh

Market area: EU

Ajax Disinfettante Clean Fresh

Market area: EU

Ajax Antibacteriano Ultra Frescura

Market area: EU

Ajax Antibacteriano

Market area: EU

Ajax Antibacterial Blue

Market area: EU

Ajax Désinfectant/Ajax Desinfecterend; Ajax Désinfectant Clean Fresh/Ajax Desinfecterend Clean Fresh; Ajax Désinfectant Fraîcheur Océan/Ajax Desinfecterend Oceaan Frisheid; Ajax Antibactérien/Ajax Antibacterieel

Market area: EU

Ajax Desinfectant; Ajax Desinfectant Clean Fresh; Ajax Desinfectant Oceaan Frisheid; Ajax Antibacterieel

Market area: EU

Authorisation number

EU-0028421-0001 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

1,57

Decan-1-ol, ethoxylated (> 2.5 moles EO)

Non-active substance

26183-52-8

500-046-6

3,0

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

| Trade name(s) | B029-1342-0014 | Market area: EU |
| --- | --- | --- |
| Ajax APC Antibacterial Blue @ 2,6 % LA (B029-1342-0014) | Market area: EU |
| Ajax Απολυμαντικό Χωρίς Χλώριο Clean Fresh + (Plus) | Market area: EU |
| Ajax Απολυμαντικό Clean Fresh + (Plus) | Market area: EU |
| Ajax Απολυμαντικό Χωρίς Χλώριο Clean Fresh + (Plus) | Market area: EU |
| Ajax Απολυμαντικό Clean Fresh + (Plus) | Market area: EU |
| Ajax Disinfettante Clean Fresh + (Plus) | Market area: EU |
| Ajax Antibacteriano Ultra Frescura + (Plus) | Market area: EU |
| Ajax Antibacteriano + (Plus) | Market area: EU |
| Ajax Antibacteriano Ultra Frescura | Market area: EU |
| Ajax Antibacterial Blue Plus | Market area: EU |
| Authorisation number | EU-0028421-0002 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 2,93 |
| Decan-1-ol, ethoxylated (> 2.5 moles EO) | | Non-active substance | 26183-52-8 | 500-046-6 | 3,0 |

Trade name(s)

B029-1342-0014

Market area: EU

Ajax APC Antibacterial Blue @ 2,6 % LA (B029-1342-0014)

Market area: EU

Ajax Απολυμαντικό Χωρίς Χλώριο Clean Fresh + (Plus)

Market area: EU

Ajax Απολυμαντικό Clean Fresh + (Plus)

Market area: EU

Ajax Απολυμαντικό Χωρίς Χλώριο Clean Fresh + (Plus)

Market area: EU

Ajax Απολυμαντικό Clean Fresh + (Plus)

Market area: EU

Ajax Disinfettante Clean Fresh + (Plus)

Market area: EU

Ajax Antibacteriano Ultra Frescura + (Plus)

Market area: EU

Ajax Antibacteriano + (Plus)

Market area: EU

Ajax Antibacteriano Ultra Frescura

Market area: EU

Ajax Antibacterial Blue Plus

Market area: EU

Authorisation number

EU-0028421-0002 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

2,93

Decan-1-ol, ethoxylated (> 2.5 moles EO)

Non-active substance

26183-52-8

500-046-6

3,0

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

| Trade name(s) | B029-4339-0011 | Market area: EU |
| --- | --- | --- |
| | Ajax APC Liquid Blue @ 1,3 % LA (ref B029-4339-0011) | Market area: EU |
| Ajax Απολυμαντικό Χωρίς Χλώριο Ocean Fresh | Market area: EU |
| Ajax Απολυμαντικό Ocean Fresh | Market area: EU |
| Ajax Maison Pure | Market area: EU |
| Ajax Απολυμαντικό Ocean Fresh | Market area: EU |
| Ajax Disinfettante Ocean Fresh | Market area: EU |
| Ajax Antibacteriano Frescura do Oceano | Market area: EU |
| Ajax Antibacteriano Frescura del Océano | Market area: EU |
| Ajax Antibacterial Pure Home | Market area: EU |
| Ajax Απολυμαντικό Χωρίς Χλώριο Ocean Fresh | Market area: EU |
| Authorisation number | EU-0028421-0003 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 1,57 |
| Decan-1-ol, ethoxylated (> 2.5 moles EO) | | Non-active substance | 26183-52-8 | 500-046-6 | 3,0 |

Trade name(s)

B029-4339-0011

Market area: EU

Ajax APC Liquid Blue @ 1,3 % LA (ref B029-4339-0011)

Market area: EU

Ajax Απολυμαντικό Χωρίς Χλώριο Ocean Fresh

Market area: EU

Ajax Απολυμαντικό Ocean Fresh

Market area: EU

Ajax Maison Pure

Market area: EU

Ajax Απολυμαντικό Ocean Fresh

Market area: EU

Ajax Disinfettante Ocean Fresh

Market area: EU

Ajax Antibacteriano Frescura do Oceano

Market area: EU

Ajax Antibacteriano Frescura del Océano

Market area: EU

Ajax Antibacterial Pure Home

Market area: EU

Ajax Απολυμαντικό Χωρίς Χλώριο Ocean Fresh

Market area: EU

Authorisation number

EU-0028421-0003 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

1,57

Decan-1-ol, ethoxylated (> 2.5 moles EO)

Non-active substance

26183-52-8

500-046-6

3,0

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

| Trade name(s) | B029-4339-0010 | Market area: EU |
| --- | --- | --- |
| | Ajax APC Liquid Blue @ 2,6 % LA (B029-4339-0010) | Market area: EU |
| Ajax Απολυμαντικό Χωρίς Χλώριο Ocean Fresh + (Plus); Ajax Απολυμαντικό Ocean Fresh + (Plus) | Market area: EU |
| Ajax Απολυμαντικό Χωρίς Χλώριο Ocean Fresh + (Plus); Ajax Απολυμαντικό Ocean Fresh + (Plus) | Market area: EU |
| Ajax Blu | Market area: EU |
| Ajax Disinfettante Ocean Fresh + (Plus) | Market area: EU |
| Ajax Pure Home | Market area: EU |
| Ajax Antibacteriano | Market area: EU |
| Ajax Antibacteriano Frescura do Oceano + (Plus) | Market area: EU |
| Ajax Antibacteriano Frescura del Océano + (Plus) | Market area: EU |
| Ajax Antibacterial Pure Home Plus | Market area: EU |
| Authorisation number | EU-0028421-0004 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 2,93 |
| Decan-1-ol, ethoxylated (> 2.5 moles EO) | | Non-active substance | 26183-52-8 | 500-046-6 | 3,0 |

Trade name(s)

B029-4339-0010

Market area: EU

Ajax APC Liquid Blue @ 2,6 % LA (B029-4339-0010)

Market area: EU

Ajax Απολυμαντικό Χωρίς Χλώριο Ocean Fresh + (Plus); Ajax Απολυμαντικό Ocean Fresh + (Plus)

Market area: EU

Ajax Απολυμαντικό Χωρίς Χλώριο Ocean Fresh + (Plus); Ajax Απολυμαντικό Ocean Fresh + (Plus)

Market area: EU

Ajax Blu

Market area: EU

Ajax Disinfettante Ocean Fresh + (Plus)

Market area: EU

Ajax Pure Home

Market area: EU

Ajax Antibacteriano

Market area: EU

Ajax Antibacteriano Frescura do Oceano + (Plus)

Market area: EU

Ajax Antibacteriano Frescura del Océano + (Plus)

Market area: EU

Ajax Antibacterial Pure Home Plus

Market area: EU

Authorisation number

EU-0028421-0004 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

2,93

Decan-1-ol, ethoxylated (> 2.5 moles EO)

Non-active substance

26183-52-8

500-046-6

3,0

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

| Trade name(s) | B029-7583-0003 | Market area: EU |
| --- | --- | --- |
| Ajax Healthy Home & Happy Blossom @ 1,3 % LA (B029-7583-0003) | Market area: EU |
| Ajax Reines Zuhause Salbei & Apfelblüten and Ajax Maison Pure Salbei & Apfelblüten andAjax Pure Home Salbei & Apfelblüten and Ajax Essential Purity Salbei & Apfelblüten and Ajax Pureté Essentielle Salbei & Apfelblüten | Market area: EU |
| Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom | Market area: EU |
| Ajax Pure Home Sage & Apple Blossom; Ajax Healthy Home Sage & Apple Blossom; Ajax Απολυμαντικό Pure Home Sage & Apple Blossom; Ajax Pure Home Μήλο & Φασκόμηλο; Ajax Pure Home Άνθη Μηλιάς & Φασκόμηλο; Ajax Pure Home Φασκόμηλο & Μήλο | Market area: EU |
| Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom | Market area: EU |
| Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom | Market area: EU |
| Ajax Maison Pure Sauge et notes de Fleurs de Pommier; Ajax Pure Home Sauge & notes de Fleur de Pommier; Ajax Essential Purity Sauge & notes de Fleur de Pommier; Ajax Pureté Essentielle Sauge & notes de Fleur de Pommier; Ajax Maison Pure Sauge & Fraîcheur Fleurs de Pommier | Market area: EU |
| Ajax Reines Zuhause Salbei & Apfelblüten; Ajax Maison Pure Salbei & Apfelblüten; Ajax Pure Home Salbei & Apfelblüten; Ajax Essential Purity Salbei & Apfelblüten; Ajax Pureté Essentielle Salbei & Apfelblüten | Market area: EU |
| Ajax Pure Home Sage & Apple Blossom; Ajax Healthy Home Sage & Apple Blossom; Ajax Απολυμαντικό Pure Home Sage & Apple Blossom; Ajax Pure Home Μήλο & Φασκόμηλο; Ajax Pure Home Άνθη Μηλιάς & Φασκόμηλο; | Market area: EU |
| Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom | Market area: EU |
| Ajax Pure Home Salvia e Mela Fiorita; Ajax Purezza di Casa Salvia e Mela Fiorita; Ajax Purezza di Casa Salvia e Fior di Mela; Ajax Pure Home Salvia e Fior di Mela; Ajax Casa Sana Salvia e Mela Fiorita; Ajax Healthy Home Salvia e Mela Fiorita; Ajax Healthy Home Salvia e Fior di Mela; Ajax Casa Sana Salvia e Fior di Mela | Market area: EU |
| Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom | Market area: EU |
| Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom | Market area: EU |
| Ajax Maison Pure Sauge & notes de Fleur de Pommier; Ajax Pure Home Sauge & notes de Fleur de Pommier; Ajax Essential Purity Sauge & notes de Fleur de Pommier; Ajax Pureté Essentielle Sauge & notes de Fleur de Pommier | Market area: EU |
| Ajax Pure Home Szałwia i Kwiat Jabłoni; Ajax Maison Pure Szałwia i Kwiat Jabłoni; Ajax Essential Purity Szałwia i Kwiat Jabłoni; Ajax Pureté Essentielle Szałwia i Kwiat Jabłoni; Ajax Pure Home Sage & Apple Blossom | Market area: EU |
| Ajax Pure Home Salva & Flor de Macieira | Market area: EU |
| Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom | Market area: EU |
| Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom | Market area: EU |
| Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom | Market area: EU |
| Ajax Hogar Limpio y Saludable con Flor de Manzana | Market area: EU |
| Ajax Maison Pure Sauge & Fleur de Pommier/Ajax Reines Zuhause Salbei & Apfelblüten; Ajax Maison Pure Sauge & Fleur de Pommier/Ajax Pure Home Salbei & Apfelblüten; Ajax Essential Purity Sauge & Fleur de Pommier/Ajax Essential Purity Salbei & Apfelblüten; Ajax Pureté Essentielle Sauge & Fleur de Pommier/Ajax Pureté Essentielle Salbei & Apfelblüten | Market area: EU |
| Ajax Pure Home Sage & Apple Blossom | Market area: EU |
| Ajax Pure Home Sauge & Fleurs de Pommier/Ajax Pure Home Salie & Appelbloesem; Ajax Pure Home Fleurs de Pommier/Ajax Pure Home Appelbloesem; Ajax Pure Home Fraîcheur Fleurs de Pommier/Ajax Pure Home Appelbloesem Frisheid; Ajax Pure Home Fraîcheur Fleurs de Pommier Antibactérien/Ajax Pure Home Appelbloesem Frisheid Ajax Pure Home Fraîcheur Fleurs de Pommier/Ajax Pure Home Appelbloesem Frisheid Antibacterieel | Market area: EU |
| Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom | Market area: EU |
| Ajax Pure Home Salie & Appelbloesem; Ajax Pure Home Appelbloesem; Ajax Pure Home Appelbloesem Frisheid; Ajax Pure Home Appelbloesem Frisheid Antibacterieel | Market area: EU |
| Authorisation number | EU-0028421-0005 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 1,57 |
| Decan-1-ol, ethoxylated (> 2.5 moles EO) | | Non-active substance | 26183-52-8 | 500-046-6 | 3,0 |

Trade name(s)

B029-7583-0003

Market area: EU

Ajax Healthy Home & Happy Blossom @ 1,3 % LA (B029-7583-0003)

Market area: EU

Ajax Reines Zuhause Salbei & Apfelblüten and Ajax Maison Pure Salbei & Apfelblüten andAjax Pure Home Salbei & Apfelblüten and Ajax Essential Purity Salbei & Apfelblüten and Ajax Pureté Essentielle Salbei & Apfelblüten

Market area: EU

Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom

Market area: EU

Ajax Pure Home Sage & Apple Blossom; Ajax Healthy Home Sage & Apple Blossom; Ajax Απολυμαντικό Pure Home Sage & Apple Blossom; Ajax Pure Home Μήλο & Φασκόμηλο; Ajax Pure Home Άνθη Μηλιάς & Φασκόμηλο; Ajax Pure Home Φασκόμηλο & Μήλο

Market area: EU

Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom

Market area: EU

Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom

Market area: EU

Ajax Maison Pure Sauge et notes de Fleurs de Pommier; Ajax Pure Home Sauge & notes de Fleur de Pommier; Ajax Essential Purity Sauge & notes de Fleur de Pommier; Ajax Pureté Essentielle Sauge & notes de Fleur de Pommier; Ajax Maison Pure Sauge & Fraîcheur Fleurs de Pommier

Market area: EU

Ajax Reines Zuhause Salbei & Apfelblüten; Ajax Maison Pure Salbei & Apfelblüten; Ajax Pure Home Salbei & Apfelblüten; Ajax Essential Purity Salbei & Apfelblüten; Ajax Pureté Essentielle Salbei & Apfelblüten

Market area: EU

Ajax Pure Home Sage & Apple Blossom; Ajax Healthy Home Sage & Apple Blossom; Ajax Απολυμαντικό Pure Home Sage & Apple Blossom; Ajax Pure Home Μήλο & Φασκόμηλο; Ajax Pure Home Άνθη Μηλιάς & Φασκόμηλο;

Market area: EU

Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom

Market area: EU

Ajax Pure Home Salvia e Mela Fiorita; Ajax Purezza di Casa Salvia e Mela Fiorita; Ajax Purezza di Casa Salvia e Fior di Mela; Ajax Pure Home Salvia e Fior di Mela; Ajax Casa Sana Salvia e Mela Fiorita; Ajax Healthy Home Salvia e Mela Fiorita; Ajax Healthy Home Salvia e Fior di Mela; Ajax Casa Sana Salvia e Fior di Mela

Market area: EU

Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom

Market area: EU

Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom

Market area: EU

Ajax Maison Pure Sauge & notes de Fleur de Pommier; Ajax Pure Home Sauge & notes de Fleur de Pommier; Ajax Essential Purity Sauge & notes de Fleur de Pommier; Ajax Pureté Essentielle Sauge & notes de Fleur de Pommier

Market area: EU

Ajax Pure Home Szałwia i Kwiat Jabłoni; Ajax Maison Pure Szałwia i Kwiat Jabłoni; Ajax Essential Purity Szałwia i Kwiat Jabłoni; Ajax Pureté Essentielle Szałwia i Kwiat Jabłoni; Ajax Pure Home Sage & Apple Blossom

Market area: EU

Ajax Pure Home Salva & Flor de Macieira

Market area: EU

Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom

Market area: EU

Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom

Market area: EU

Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom

Market area: EU

Ajax Hogar Limpio y Saludable con Flor de Manzana

Market area: EU

Ajax Maison Pure Sauge & Fleur de Pommier/Ajax Reines Zuhause Salbei & Apfelblüten; Ajax Maison Pure Sauge & Fleur de Pommier/Ajax Pure Home Salbei & Apfelblüten; Ajax Essential Purity Sauge & Fleur de Pommier/Ajax Essential Purity Salbei & Apfelblüten; Ajax Pureté Essentielle Sauge & Fleur de Pommier/Ajax Pureté Essentielle Salbei & Apfelblüten

Market area: EU

Ajax Pure Home Sage & Apple Blossom

Market area: EU

Ajax Pure Home Sauge & Fleurs de Pommier/Ajax Pure Home Salie & Appelbloesem; Ajax Pure Home Fleurs de Pommier/Ajax Pure Home Appelbloesem; Ajax Pure Home Fraîcheur Fleurs de Pommier/Ajax Pure Home Appelbloesem Frisheid; Ajax Pure Home Fraîcheur Fleurs de Pommier Antibactérien/Ajax Pure Home Appelbloesem Frisheid Ajax Pure Home Fraîcheur Fleurs de Pommier/Ajax Pure Home Appelbloesem Frisheid Antibacterieel

Market area: EU

Ajax Pure Home Sage & Apple Blossom; Ajax Maison Pure Sage & Apple Blossom; Ajax Essential Purity Sage & Apple Blossom; Ajax Pureté Essentielle Sage & Apple Blossom

Market area: EU

Ajax Pure Home Salie & Appelbloesem; Ajax Pure Home Appelbloesem; Ajax Pure Home Appelbloesem Frisheid; Ajax Pure Home Appelbloesem Frisheid Antibacterieel

Market area: EU

Authorisation number

EU-0028421-0005 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

1,57

Decan-1-ol, ethoxylated (> 2.5 moles EO)

Non-active substance

26183-52-8

500-046-6

3,0

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

| Trade name(s) | B029-7583-0002 | Market area: EU |
| --- | --- | --- |
| | Ajax Healthy Home & Happy Blossom @ 2,6 % LA (B029-7583-0002) | Market area: EU |
| Ajax Healthy Home Sage & Apple Blossom + (Plus); Ajax Απολυμαντικό Pure Home Sage & Apple Blossom + (Plus); Ajax Pure Home Μήλο & Φασκόμηλο + (Plus); Ajax Pure Home Άνθη Μηλιάς & Φασκόμηλο + (Plus); Ajax Pure Home Φασκόμηλο & Μήλο + (Plus) | Market area: EU |
| Ajax Healthy Home Sage & Apple Blossom + (Plus); Ajax Απολυμαντικό Pure Home Sage & Apple Blossom + (Plus); Ajax Pure Home Μήλο & Φασκόμηλο + (Plus); Ajax Pure Home Άνθη Μηλιάς & Φασκόμηλο + (Plus); Ajax Pure Home Φασκόμηλο & Μήλο + (Plus) | Market area: EU |
| Ajax Healthy Home Allegria Floreale; Ajax Healthy Home Fioritura Allegra; Ajax Casa Sana Fioritura Allegra; Ajax Casa Sana Fiore Allegro; Ajax Casa Sana Allegria Floreale; Ajax Healthy Home Fiore Allegro. | Market area: EU |
| Ajax Pure Home Salva & Flor de Macieira + (Plus) | Market area: EU |
| Ajax Hogar Limpio y Saludable con Flor de Manzana + (Plus) | Market area: EU |
| Ajax Pure Home Sage & Apple Blossom Plus | Market area: EU |
| Authorisation number | EU-0028421-0006 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 2,93 |
| Decan-1-ol, ethoxylated (> 2.5 moles EO) | | Non-active substance | 26183-52-8 | 500-046-6 | 3,0 |

Trade name(s)

B029-7583-0002

Market area: EU

Ajax Healthy Home & Happy Blossom @ 2,6 % LA (B029-7583-0002)

Market area: EU

Ajax Healthy Home Sage & Apple Blossom + (Plus); Ajax Απολυμαντικό Pure Home Sage & Apple Blossom + (Plus); Ajax Pure Home Μήλο & Φασκόμηλο + (Plus); Ajax Pure Home Άνθη Μηλιάς & Φασκόμηλο + (Plus); Ajax Pure Home Φασκόμηλο & Μήλο + (Plus)

Market area: EU

Ajax Healthy Home Sage & Apple Blossom + (Plus); Ajax Απολυμαντικό Pure Home Sage & Apple Blossom + (Plus); Ajax Pure Home Μήλο & Φασκόμηλο + (Plus); Ajax Pure Home Άνθη Μηλιάς & Φασκόμηλο + (Plus); Ajax Pure Home Φασκόμηλο & Μήλο + (Plus)

Market area: EU

Ajax Healthy Home Allegria Floreale; Ajax Healthy Home Fioritura Allegra; Ajax Casa Sana Fioritura Allegra; Ajax Casa Sana Fiore Allegro; Ajax Casa Sana Allegria Floreale; Ajax Healthy Home Fiore Allegro.

Market area: EU

Ajax Pure Home Salva & Flor de Macieira + (Plus)

Market area: EU

Ajax Hogar Limpio y Saludable con Flor de Manzana + (Plus)

Market area: EU

Ajax Pure Home Sage & Apple Blossom Plus

Market area: EU

Authorisation number

EU-0028421-0006 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

2,93

Decan-1-ol, ethoxylated (> 2.5 moles EO)

Non-active substance

26183-52-8

500-046-6

3,0

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

| Trade name(s) | B029-7582-0000 | Market area: EU |
| --- | --- | --- |
| Ajax Healthy Home Sage & Elder Flower @ 1,3 % LA (B029-7583-0000) | Market area: EU |
| Ajax Reines Zuhause Salbei & Holunderblüten; Ajax Maison Pure Salbei & Holunderblüten; Ajax Pure Home Salbei & Holunderblüten; Ajax Essential Purity Salbei & Holunderblüten; Ajax Pureté Essentielle Salbei & Holunderblüten | Market area: EU |
| Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower | Market area: EU |
| Ajax Pure Home Sage & Elderflower; Ajax Healthy Home Sage & Elderflower; Ajax Απολυμαντικό Pure Home Sage & Elderflower; Ajax Pure Home Φασκόμηλο & Κουφοξυλιά; Ajax Pure Home Κουφοξυλιά & Φασκόμηλο; | Market area: EU |
| Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower | Market area: EU |
| Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower | Market area: EU |
| Ajax Maison Pure Sauge et Fleur de Sureau; Ajax Pure Home Sauge & Fleur de Sureau; Ajax Essential Purity Sauge & Fleur de Sureau; Ajax Pureté Essentielle Sauge & Fleur de Sureau; Ajax Maison Pure Sauge & Fraîcheur Fleurs de Sureau | Market area: EU |
| Ajax Reines Zuhause Salbei & Holunderblüten; Ajax Maison Pure Salbei & Holunderblüten; Ajax Pure Home Salbei & Holunderblüten; Ajax Essential Purity Salbei & Holunderblüten; Ajax Pureté Essentielle Salbei & Holunderblüten | Market area: EU |
| Ajax Pure Home Sage & Elderflower; Ajax Healthy HomeSage & Elderflower; Ajax Απολυμαντικό Pure Home Sage & Elderflower; Ajax Pure Home Κουφοξυλιά & Φασκόμηλο; Ajax Pure Home Φασκόμηλο &Κουφοξυλιά; Ajax Pure Home Άνθη Ακτέας & Φασκόμηλο | Market area: EU |
| Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower | Market area: EU |
| Ajax Healthy Home Salvia e Fiore di Sambuco; Ajax Casa Sana Salvia e Fiore di Sambuco; Ajax Pure Home Salvia e Fiore di Sambuco; Ajax Purezza di Casa Salvia e Fiore di Sambuco; | Market area: EU |
| Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower | Market area: EU |
| Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower | Market area: EU |
| Ajax Maison Pure Sauge & Fleur de Sureau; Ajax Pure Home Sauge & Fleur de Sureau; Ajax Essential Purity Sauge & Fleur de Sureau; Ajax Pureté Essentielle Sauge & Fleur de Sureau | Market area: EU |
| Ajax Pure Home Szałwia i Kwiat Czarnego Bzu; Ajax Maison Pure Szałwia i Kwiat Czarnego Bzu; Ajax Essential Purity Szałwia i Kwiat Czarnego Bzu; Ajax Pureté Essentielle Szałwia i Kwiat Czarnego Bzu; Ajax Pure Home Sage & ElderflowerAjax Pure Home Sage & Elderflower | Market area: EU |
| Ajax Pure Home Salva & Flor de Sabugueiro | Market area: EU |
| Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower | Market area: EU |
| Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower | Market area: EU |
| Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower | Market area: EU |
| Ajax Hogar Limpio y Saludable con Flor de Saúco | Market area: EU |
| Ajax Maison Pure Sauge & Fleur de Sureau/Ajax Reines Zuhause Salbei & Holunderblüten; Ajax Pure Home Sauge & Fleur de Sureau/Ajax Pure Home Salbei & Holunderblüten; Ajax Essential Purity Sauge & Fleur de Sureau/Ajax Essential Purity Salbei & Holunderblüten; Ajax Pureté Essentielle Sauge & Fleur de Sureau/Ajax Pureté Essentielle Salbei & Holunderblüten | Market area: EU |
| Ajax Pure Home Sage & Elder Flower | Market area: EU |
| Ajax Pure Home Sauge & Fleur de Sureau/Ajax Pure Home Salie & Vlierbloesem; Ajax Pure Home Fleur de Sureau/Ajax Pure Home Vlierbloesem; Ajax Pure Home Fraîcheur Fleur de Sureau/Ajax Pure Home Vlierbloesem Frisheid; Ajax Pure Home Fraîcheur Fleur de Sureau Antibactérien/Ajax Pure Home Vlierbloesem Frisheid Antibacterieel | Market area: EU |
| Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower | Market area: EU |
| Ajax Pure Home Salie & Vlierbloesem; Ajax Pure Home Vlierbloesem; Ajax Pure Home Vlierbloesem Frisheid; Ajax Pure Home Vlierbloesem Frisheid Antibacterieel | Market area: EU |
| Authorisation number | EU-0028421-0007 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 1,57 |
| Decan-1-ol, ethoxylated (> 2.5 moles EO) | | Non-active substance | 26183-52-8 | 500-046-6 | 3,0 |

Trade name(s)

B029-7582-0000

Market area: EU

Ajax Healthy Home Sage & Elder Flower @ 1,3 % LA (B029-7583-0000)

Market area: EU

Ajax Reines Zuhause Salbei & Holunderblüten; Ajax Maison Pure Salbei & Holunderblüten; Ajax Pure Home Salbei & Holunderblüten; Ajax Essential Purity Salbei & Holunderblüten; Ajax Pureté Essentielle Salbei & Holunderblüten

Market area: EU

Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower

Market area: EU

Ajax Pure Home Sage & Elderflower; Ajax Healthy Home Sage & Elderflower; Ajax Απολυμαντικό Pure Home Sage & Elderflower; Ajax Pure Home Φασκόμηλο & Κουφοξυλιά; Ajax Pure Home Κουφοξυλιά & Φασκόμηλο;

Market area: EU

Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower

Market area: EU

Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower

Market area: EU

Ajax Maison Pure Sauge et Fleur de Sureau; Ajax Pure Home Sauge & Fleur de Sureau; Ajax Essential Purity Sauge & Fleur de Sureau; Ajax Pureté Essentielle Sauge & Fleur de Sureau; Ajax Maison Pure Sauge & Fraîcheur Fleurs de Sureau

Market area: EU

Ajax Reines Zuhause Salbei & Holunderblüten; Ajax Maison Pure Salbei & Holunderblüten; Ajax Pure Home Salbei & Holunderblüten; Ajax Essential Purity Salbei & Holunderblüten; Ajax Pureté Essentielle Salbei & Holunderblüten

Market area: EU

Ajax Pure Home Sage & Elderflower; Ajax Healthy HomeSage & Elderflower; Ajax Απολυμαντικό Pure Home Sage & Elderflower; Ajax Pure Home Κουφοξυλιά & Φασκόμηλο; Ajax Pure Home Φασκόμηλο &Κουφοξυλιά; Ajax Pure Home Άνθη Ακτέας & Φασκόμηλο

Market area: EU

Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower

Market area: EU

Ajax Healthy Home Salvia e Fiore di Sambuco; Ajax Casa Sana Salvia e Fiore di Sambuco; Ajax Pure Home Salvia e Fiore di Sambuco; Ajax Purezza di Casa Salvia e Fiore di Sambuco;

Market area: EU

Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower

Market area: EU

Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower

Market area: EU

Ajax Maison Pure Sauge & Fleur de Sureau; Ajax Pure Home Sauge & Fleur de Sureau; Ajax Essential Purity Sauge & Fleur de Sureau; Ajax Pureté Essentielle Sauge & Fleur de Sureau

Market area: EU

Ajax Pure Home Szałwia i Kwiat Czarnego Bzu; Ajax Maison Pure Szałwia i Kwiat Czarnego Bzu; Ajax Essential Purity Szałwia i Kwiat Czarnego Bzu; Ajax Pureté Essentielle Szałwia i Kwiat Czarnego Bzu; Ajax Pure Home Sage & ElderflowerAjax Pure Home Sage & Elderflower

Market area: EU

Ajax Pure Home Salva & Flor de Sabugueiro

Market area: EU

Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower

Market area: EU

Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower

Market area: EU

Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower

Market area: EU

Ajax Hogar Limpio y Saludable con Flor de Saúco

Market area: EU

Ajax Maison Pure Sauge & Fleur de Sureau/Ajax Reines Zuhause Salbei & Holunderblüten; Ajax Pure Home Sauge & Fleur de Sureau/Ajax Pure Home Salbei & Holunderblüten; Ajax Essential Purity Sauge & Fleur de Sureau/Ajax Essential Purity Salbei & Holunderblüten; Ajax Pureté Essentielle Sauge & Fleur de Sureau/Ajax Pureté Essentielle Salbei & Holunderblüten

Market area: EU

Ajax Pure Home Sage & Elder Flower

Market area: EU

Ajax Pure Home Sauge & Fleur de Sureau/Ajax Pure Home Salie & Vlierbloesem; Ajax Pure Home Fleur de Sureau/Ajax Pure Home Vlierbloesem; Ajax Pure Home Fraîcheur Fleur de Sureau/Ajax Pure Home Vlierbloesem Frisheid; Ajax Pure Home Fraîcheur Fleur de Sureau Antibactérien/Ajax Pure Home Vlierbloesem Frisheid Antibacterieel

Market area: EU

Ajax Pure Home Sage & Elderflower; Ajax Maison Pure Sage & Elderflower; Ajax Essential Purity Sage & Elderflower; Ajax Pureté Essentielle Sage & Elderflower

Market area: EU

Ajax Pure Home Salie & Vlierbloesem; Ajax Pure Home Vlierbloesem; Ajax Pure Home Vlierbloesem Frisheid; Ajax Pure Home Vlierbloesem Frisheid Antibacterieel

Market area: EU

Authorisation number

EU-0028421-0007 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

1,57

Decan-1-ol, ethoxylated (> 2.5 moles EO)

Non-active substance

26183-52-8

500-046-6

3,0

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

| Trade name(s) | B029-7582-0001 | Market area: EU |
| --- | --- | --- |
| | Ajax Healthy Home Sage & Elder Flower @ 2,6 % LA (B029-7582-0001) | Market area: EU |
| Ajax Pure Home Sage & Elderflower + (Plus); Ajax Healthy Home Sage & Elderflower + (Plus); Ajax Απολυμαντικό Pure Home Sage & Elderflower + (Plus); Ajax Pure Home Φασκόμηλο & Κουφοξυλιά + (Plus); Ajax Pure Home Κουφοξυλιά & Φασκόμηλο+ (Plus) | Market area: EU |
| Ajax Pure Home Sage & Elderflower + (Plus); Ajax Healthy Home Sage & Elderflower + (Plus); Ajax Απολυμαντικό Pure Home Sage & Elderflower + (Plus); Ajax Pure Home Φασκόμηλο & Κουφοξυλιά + (Plus); Ajax Pure Home Κουφοξυλιά & Φασκόμηλο+ (Plus) | Market area: EU |
| Ajax Healthy Home Salvia e Fiore di Sambuco + (Plus); Ajax Casa Sana Salvia e fiore di Sambuco + (Plus) | Market area: EU |
| Ajax Pure Home Salva & Flor de Sabugueiro + (Plus) | Market area: EU |
| Ajax Hogar Limpio y Saludable con Flor de Saúco + (Plus) | Market area: EU |
| Ajax Pure Home Sage & Elder Flower Plus | Market area: EU |
| Authorisation number | EU-0028421-0008 1-1 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 2,93 |
| Decan-1-ol, ethoxylated (> 2.5 moles EO) | | Non-active substance | 26183-52-8 | 500-046-6 | 3,0 |

Trade name(s)

B029-7582-0001

Market area: EU

Ajax Healthy Home Sage & Elder Flower @ 2,6 % LA (B029-7582-0001)

Market area: EU

Ajax Pure Home Sage & Elderflower + (Plus); Ajax Healthy Home Sage & Elderflower + (Plus); Ajax Απολυμαντικό Pure Home Sage & Elderflower + (Plus); Ajax Pure Home Φασκόμηλο & Κουφοξυλιά + (Plus); Ajax Pure Home Κουφοξυλιά & Φασκόμηλο+ (Plus)

Market area: EU

Ajax Pure Home Sage & Elderflower + (Plus); Ajax Healthy Home Sage & Elderflower + (Plus); Ajax Απολυμαντικό Pure Home Sage & Elderflower + (Plus); Ajax Pure Home Φασκόμηλο & Κουφοξυλιά + (Plus); Ajax Pure Home Κουφοξυλιά & Φασκόμηλο+ (Plus)

Market area: EU

Ajax Healthy Home Salvia e Fiore di Sambuco + (Plus); Ajax Casa Sana Salvia e fiore di Sambuco + (Plus)

Market area: EU

Ajax Pure Home Salva & Flor de Sabugueiro + (Plus)

Market area: EU

Ajax Hogar Limpio y Saludable con Flor de Saúco + (Plus)

Market area: EU

Ajax Pure Home Sage & Elder Flower Plus

Market area: EU

Authorisation number

EU-0028421-0008 1-1

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

2,93

Decan-1-ol, ethoxylated (> 2.5 moles EO)

Non-active substance

26183-52-8

500-046-6

3,0

META SPC 2

1.   META SPC 2 ADMINISTRATIVE INFORMATION

1.1.   Meta SPC 2 identifier

| Identifier | META SPC5 PT2 WIPES |
| --- | --- |

Identifier

META SPC5 PT2 WIPES

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 |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 3,67 | 4,19 |
| Propan-2-ol | | Non-active substance | 67-63-0 | 200-661-7 | 0,1 | 0,1 |

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

Min

Max

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

3,67

4,19

Propan-2-ol

Non-active substance

67-63-0

200-661-7

0,1

0,1

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.
  May be corrosive to metals. |
| --- | --- |
| Precautionary statements | If medical advice is needed, have product container or label at hand.
  Keep out of reach of children.
  Read carefully and follow all instructions.
  Wash thoroughly after handling.
  IF ON SKIN:Wash with plenty of water.
  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/doctor/....
  Specific treatment (see on this label).
  If skin irritation occurs:Get medical advice.
  Take off contaminated clothing.And wash it before reuse.
  Keep only in original packaging.
  Absorb spillage to prevent material damage.
  Store in a corrosive resistant/... container with a resistant inner liner. |

Hazard statements

Causes skin irritation.

Causes serious eye damage.

May be corrosive to metals.

Precautionary statements

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

Keep out of reach of children.

Read carefully and follow all instructions.

Wash thoroughly after handling.

IF ON SKIN:Wash with plenty of water.

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/doctor/....

Specific treatment (see on this label).

If skin irritation occurs:Get medical advice.

Take off contaminated clothing.And wash it before reuse.

Keep only in original packaging.

Absorb spillage to prevent material damage.

Store in a corrosive resistant/... container with a resistant inner liner.

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

4.1.   Use description

Table 3

Use # 1 – Hard surface disinfection – domestic surfaces other than kitchen

| 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: Bacteria
  Common name: Bacteria
  Development stage: |
| Field(s) of use | Indoor
  Household – Bathroom and non-porous hard surfaces other than kitchen. |
| Application method(s) | Method: Wiping
  Detailed description:
  Without pre-cleaning
  Rinsing required |
| Application rate(s) and frequency | Application Rate: -
  Dilution (%): -
  Number and timing of application:
  Ready to use
  Contact time: 5 minutes
  Room temperature
  Frequency: daily |
| Category(ies) of users | General public (non-professional) |
| Pack sizes and packaging material | Laminated PE/PET resealable flow-pack with pre-cut on opening coupled with a plastic closure with 25, 35, 40, 50, 60 wipes |

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: Bacteria

Common name: Bacteria

Development stage:

Field(s) of use

Indoor

Household – Bathroom and non-porous hard surfaces other than kitchen.

Application method(s)

Method: Wiping

Detailed description:

Without pre-cleaning

Rinsing required

Application rate(s) and frequency

Application Rate: -

Dilution (%): -

Number and timing of application:

Ready to use

Contact time: 5 minutes

Room temperature

Frequency: daily

Category(ies) of users

General public (non-professional)

Pack sizes and packaging material

Laminated PE/PET resealable flow-pack with pre-cut on opening coupled with a plastic closure with 25, 35, 40, 50, 60 wipes

4.1.1.   Use-specific instructions for use

| — | For multipack wipes, close the package after opening |
| --- | --- |

—

For multipack wipes, close the package after opening

4.1.2.   Use-specific risk mitigation measures

-

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

-

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

-

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

-

4.2.   Use description

Table 4

Use # 2 – Toilet bowl surfaces disinfection

| 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: Bacteria
  Common name: Bacteria
  Development stage: |
| Field(s) of use | Indoor
  Household toilets – Disinfection for Toilets bowls surfaces – Non-porous hard surface disinfection |
| Application method(s) | Method: Wiping
  Detailed description:
  Without pre-cleaning
  Rinsing required |
| Application rate(s) and frequency | Application Rate: -
  Dilution (%): -
  Number and timing of application:
  Ready to use
  Contact time: 5 minutes
  Frequency: daily |
| Category(ies) of users | General public (non-professional) |
| Pack sizes and packaging material | Laminated PE/PET resealable flow-pack with pre-cut on opening coupled with a plastic closure 25, 35, 40, 50, 60 wipes |

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: Bacteria

Common name: Bacteria

Development stage:

Field(s) of use

Indoor

Household toilets – Disinfection for Toilets bowls surfaces – Non-porous hard surface disinfection

Application method(s)

Method: Wiping

Detailed description:

Without pre-cleaning

Rinsing required

Application rate(s) and frequency

Application Rate: -

Dilution (%): -

Number and timing of application:

Ready to use

Contact time: 5 minutes

Frequency: daily

Category(ies) of users

General public (non-professional)

Pack sizes and packaging material

Laminated PE/PET resealable flow-pack with pre-cut on opening coupled with a plastic closure 25, 35, 40, 50, 60 wipes

4.2.1.   Use-specific instructions for use

4.2.2.   Use-specific risk mitigation measures

-

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

-

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

-

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

-

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

5.1.   Instructions for use

| — | Comply with the instruction of use. |
| --- | --- |

—

Comply with the instruction of use.

| — | Inform the registration holder if the treatment is ineffective. |
| --- | --- |

—

Inform the registration holder if the treatment is ineffective.

| — | Apply on non porous surfaces |
| --- | --- |

—

Apply on non porous surfaces

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

—

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

| — | For multipack wipes, close the package after opening. |
| --- | --- |

—

For multipack wipes, close the package after opening.

| — | Let the surface dry after rinsing |
| --- | --- |

—

Let the surface dry after rinsing

5.2.   Risk mitigation measures

| — | Wash hands after use |
| --- | --- |

—

Wash hands after use

| — | Avoid contact with eyes. |
| --- | --- |

—

Avoid contact with eyes.

| — | Do not touch the surface until the surface is rinsed and dry. |
| --- | --- |

—

Do not touch the surface until the surface is rinsed and dry.

| — | Children and pets should not be present during disinfection and until the surface is rinsed and dry. |
| --- | --- |

—

Children and pets should not be present during disinfection and until the surface is rinsed and dry.

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

| — | IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice. |
| --- | --- |

—

IF ON SKIN: Take off all contaminated clothing and wash it before reuse. Wash skin with water. If skin irritation occurs: Get medical advice.

| — | IF IN EYES: Immediately rinse with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing for at least 15 minutes.
  Call 112/ambulance for medical assistance.
  Information to Healthcare personnel/doctor:
  The eyes should also be rinsed repeatedly on the way to the doctor if eye exposure to alkaline chemicals (pH > 11), amines and acids like acetic acid, formic acid or propionic acid |
| --- | --- |

—

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

Call 112/ambulance for medical assistance.

Information to Healthcare personnel/doctor:

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

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

—

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

| — | IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. Seek medical advice immediately if symptoms occur and/or large quantities have been inhaled.
  If medical advice is needed, have product container or label at hand |
| --- | --- |

—

IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. Seek medical advice immediately if symptoms occur and/or large quantities have been inhaled.

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

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

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

—

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

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

—

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

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

| — | Shelf life: 1 year |
| --- | --- |

—

Shelf life: 1 year

| — | Do not store above 30 °C |
| --- | --- |

—

Do not store above 30 °C

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

—

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

6.   OTHER INFORMATION

-

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) | B023-1874-0010 | Market area: EU |
| --- | --- | --- |
| Ajax Optimal 7 Wipes Bathroom and Toilet @ 3,5 % (ref B023-1874-0010) | Market area: EU |
| Ajax Antibakterielle Reinigungstücher Bad & WC; Ajax Power Antibakterielle Reinigungstücher Bad & WC | Market area: EU |
| Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC | Market area: EU |
| Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC | Market area: EU |
| Ajax Expert Μπάνιο & Λεκάνη; Ajax Μπάνιο & Λεκάνη; Πανάκια Ajax Μπάνιο & Λεκάνη; Ajax Πανάκια Μπάνιο & Λεκάνη; Ajax Plant Based Μπάνιο & WC Απολυμαντικό | Market area: EU |
| Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC | Market area: EU |
| Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC | Market area: EU |
| Ajax Optimal 7 Salle de bain & WC Antibactérien; Ajax Salle de bain & WC Antibactérien; Ajax Power Anti-calcaire; Ajax Lingettes Antibactériennes Salle de Bain & WC; Ajax Lingettes Désinfectantes Salle de Bain & WC | Market area: EU |
| Ajax Ultra 7 Antibakterielle Reinigungstücher Bad & WC; Ajax Antibakterielle Reinigungstücher Bad & WC; Ajax Power Antibakterielle Reinigungstücher Bad & WC | Market area: EU |
| Ajax Μπάνιο & Λεκάνη; Ajax Expert Μπάνιο & Λεκάνη; Ajax Μπάνιο & Λεκάνη; Πανάκια Ajax Μπάνιο & Λεκάνη; Ajax Πανάκια Μπάνιο & Λεκάνη; Ajax Plant Based Μπάνιο & WC Απολυμαντικό | Market area: EU |
| Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC | Market area: EU |
| Ajax Salviettine Bagno e WC; Salviette Ajax Plant Based Bagno | Market area: EU |
| Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC | Market area: EU |
| Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC | Market area: EU |
| Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC, Ajax Łazienka i WC | Market area: EU |
| Toalhitas Ajax Casa de Banho Frescura Pura; Ajax Plant Based Casa de Banho & Ação Antibacteriana | Market area: EU |
| Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC | Market area: EU |
| Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC | Market area: EU |
| Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC | Market area: EU |
| Ajax Baños | Market area: EU |
| Ajax antibakterielle Reinigungstücher Bad & WC/Ajax lingettes nettoyantes antibactériennes Bain & WC | Market area: EU |
| Ajax Antibacterial Wipes Pure Freshness | Market area: EU |
| Ajax Antibacterial Wipes Bathroom; Ajax Antibacterial Wipes Bathroom & WC; Ajax Lingettes Antibactériennes Salle de Bain/Ajax Antibacteriële Doekjes Badkamer; Ajax Lingettes Antibactériennes Salle de Bain & WC/Ajax Antibacteriële Doekjes Badkamer & WC; Ajax Lingettes Désinfectantes Salle de Bain/Ajax Desinfecterende Doekjes Badkamer; Ajax Lingettes Désinfectantes Salle de Bain & WC/Ajax Desinfecterende Doekjes Badkamer & WC | Market area: EU |
| Ajax Antibacterial Wipes Bathroom; Ajax Antibacterial Wipes Bathroom & WC; Ajax Lingettes Antibactériennes Salle de Bain/Ajax Antibacteriële Doekjes Badkamer; Ajax Lingettes Antibactériennes Salle de Bain & WC/Ajax Antibacteriële Doekjes Badkamer & WC; Ajax Lingettes Désinfectantes Salle de Bain/Ajax Desinfecterende Doekjes Badkamer; Ajax Lingettes Désinfectantes Salle de Bain & WC/Ajax Desinfecterende Doekjes Badkamer & WC | Market area: EU |
| Authorisation number | EU-0028421-0009 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 3,67 |
| Propan-2-ol | | Non-active substance | 67-63-0 | 200-661-7 | 0,1 |

Trade name(s)

B023-1874-0010

Market area: EU

Ajax Optimal 7 Wipes Bathroom and Toilet @ 3,5 % (ref B023-1874-0010)

Market area: EU

Ajax Antibakterielle Reinigungstücher Bad & WC; Ajax Power Antibakterielle Reinigungstücher Bad & WC

Market area: EU

Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC

Market area: EU

Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC

Market area: EU

Ajax Expert Μπάνιο & Λεκάνη; Ajax Μπάνιο & Λεκάνη; Πανάκια Ajax Μπάνιο & Λεκάνη; Ajax Πανάκια Μπάνιο & Λεκάνη; Ajax Plant Based Μπάνιο & WC Απολυμαντικό

Market area: EU

Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC

Market area: EU

Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC

Market area: EU

Ajax Optimal 7 Salle de bain & WC Antibactérien; Ajax Salle de bain & WC Antibactérien; Ajax Power Anti-calcaire; Ajax Lingettes Antibactériennes Salle de Bain & WC; Ajax Lingettes Désinfectantes Salle de Bain & WC

Market area: EU

Ajax Ultra 7 Antibakterielle Reinigungstücher Bad & WC; Ajax Antibakterielle Reinigungstücher Bad & WC; Ajax Power Antibakterielle Reinigungstücher Bad & WC

Market area: EU

Ajax Μπάνιο & Λεκάνη; Ajax Expert Μπάνιο & Λεκάνη; Ajax Μπάνιο & Λεκάνη; Πανάκια Ajax Μπάνιο & Λεκάνη; Ajax Πανάκια Μπάνιο & Λεκάνη; Ajax Plant Based Μπάνιο & WC Απολυμαντικό

Market area: EU

Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC

Market area: EU

Ajax Salviettine Bagno e WC; Salviette Ajax Plant Based Bagno

Market area: EU

Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC

Market area: EU

Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC

Market area: EU

Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC, Ajax Łazienka i WC

Market area: EU

Toalhitas Ajax Casa de Banho Frescura Pura; Ajax Plant Based Casa de Banho & Ação Antibacteriana

Market area: EU

Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC

Market area: EU

Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC

Market area: EU

Ajax Power Bathroom; Ajax Power Antilimescale; Ajax Bathroom & WC

Market area: EU

Ajax Baños

Market area: EU

Ajax antibakterielle Reinigungstücher Bad & WC/Ajax lingettes nettoyantes antibactériennes Bain & WC

Market area: EU

Ajax Antibacterial Wipes Pure Freshness

Market area: EU

Ajax Antibacterial Wipes Bathroom; Ajax Antibacterial Wipes Bathroom & WC; Ajax Lingettes Antibactériennes Salle de Bain/Ajax Antibacteriële Doekjes Badkamer; Ajax Lingettes Antibactériennes Salle de Bain & WC/Ajax Antibacteriële Doekjes Badkamer & WC; Ajax Lingettes Désinfectantes Salle de Bain/Ajax Desinfecterende Doekjes Badkamer; Ajax Lingettes Désinfectantes Salle de Bain & WC/Ajax Desinfecterende Doekjes Badkamer & WC

Market area: EU

Ajax Antibacterial Wipes Bathroom; Ajax Antibacterial Wipes Bathroom & WC; Ajax Lingettes Antibactériennes Salle de Bain/Ajax Antibacteriële Doekjes Badkamer; Ajax Lingettes Antibactériennes Salle de Bain & WC/Ajax Antibacteriële Doekjes Badkamer & WC; Ajax Lingettes Désinfectantes Salle de Bain/Ajax Desinfecterende Doekjes Badkamer; Ajax Lingettes Désinfectantes Salle de Bain & WC/Ajax Desinfecterende Doekjes Badkamer & WC

Market area: EU

Authorisation number

EU-0028421-0009 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

3,67

Propan-2-ol

Non-active substance

67-63-0

200-661-7

0,1

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

| Trade name(s) | B023-1874-0011 | Market area: EU |
| --- | --- | --- |
| | Ajax Optimal 7 Wipes Bathroom and Toilet @ 4 % (ref B023-1874-0011) | Market area: EU |
| Ajax Expert Μπάνιο & Λεκάνη + (Plus); Ajax Μπάνιο & Λεκάνη + (Plus); Πανάκια Ajax Μπάνιο & Λεκάνη + (Plus); Ajax Πανάκια Μπάνιο & Λεκάνη + (Plus); Ajax Plant Based Μπάνιο & WC Απολυμαντικό | Market area: EU |
| Ajax Μπάνιο & Λεκάνη + (Plus); Ajax Expert Μπάνιο & Λεκάνη + (Plus); Ajax Μπάνιο & Λεκάνη + (Plus); Πανάκια Ajax Μπάνιο & Λεκάνη + (Plus); Ajax Πανάκια Μπάνιο & Λεκάνη + (Plus); Ajax Plant Based Μπάνιο & WC Απολυμαντικό | Market area: EU |
| Ajax Salviettine Bagno e WC + (Plus); Salviette Ajax Plant Base Bagno | Market area: EU |
| Toalhitas Ajax Casa de Banho Frescura Pura + (Plus); Ajax Plant Based Casa de Banho & Ação Antibacteriana | Market area: EU |
| Ajax Baños + (Plus) | Market area: EU |
| Ajax antibakterielle Reinigungstücher Bad & WC/Ajax lingettes nettoyantes antibactériennes Bain & WC | Market area: EU |
| Ajax Antibacterial Wipes Pure Freshness Plus | Market area: EU |
| Authorisation number | EU-0028421-0010 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 4,19 |
| Propan-2-ol | | Non-active substance | 67-63-0 | 200-661-7 | 0,1 |

Trade name(s)

B023-1874-0011

Market area: EU

Ajax Optimal 7 Wipes Bathroom and Toilet @ 4 % (ref B023-1874-0011)

Market area: EU

Ajax Expert Μπάνιο & Λεκάνη + (Plus); Ajax Μπάνιο & Λεκάνη + (Plus); Πανάκια Ajax Μπάνιο & Λεκάνη + (Plus); Ajax Πανάκια Μπάνιο & Λεκάνη + (Plus); Ajax Plant Based Μπάνιο & WC Απολυμαντικό

Market area: EU

Ajax Μπάνιο & Λεκάνη + (Plus); Ajax Expert Μπάνιο & Λεκάνη + (Plus); Ajax Μπάνιο & Λεκάνη + (Plus); Πανάκια Ajax Μπάνιο & Λεκάνη + (Plus); Ajax Πανάκια Μπάνιο & Λεκάνη + (Plus); Ajax Plant Based Μπάνιο & WC Απολυμαντικό

Market area: EU

Ajax Salviettine Bagno e WC + (Plus); Salviette Ajax Plant Base Bagno

Market area: EU

Toalhitas Ajax Casa de Banho Frescura Pura + (Plus); Ajax Plant Based Casa de Banho & Ação Antibacteriana

Market area: EU

Ajax Baños + (Plus)

Market area: EU

Ajax antibakterielle Reinigungstücher Bad & WC/Ajax lingettes nettoyantes antibactériennes Bain & WC

Market area: EU

Ajax Antibacterial Wipes Pure Freshness Plus

Market area: EU

Authorisation number

EU-0028421-0010 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

4,19

Propan-2-ol

Non-active substance

67-63-0

200-661-7

0,1

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

| Trade name(s) | B023-1873-0006 | Market area: EU |
| --- | --- | --- |
| Ajax Optimal 7 Wipes Multisurfaces @ 3,5 % (ref B023-1873-0006) | Market area: EU |
| Ajax Ultra 7 Antibakterielle Reinigungstücher; Ajax Antibakterielle Reinigungstücher; Ajax Power Antibakterielle Reinigungstücher | Market area: EU |
| Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface | Market area: EU |
| Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface | Market area: EU |
| Ajax Expert Για Όλες τις Επιφάνειες; Ajax Πανάκια Για Όλες τις Επιφάνειες; Πανάκια Ajax Για Όλες τις Επιφάνειες; Ajax Plant Based για Όλες τις Επιφάνειες & Απολυμαντικό | Market area: EU |
| Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface | Market area: EU |
| Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface | Market area: EU |
| Ajax Optimal 7 Surfaces Grasses Antibactérien; Ajax Surfaces Grasses; Ajax Power; Ajax Multisurfaces, Ajax Lingettes Antibactériennes Multi-Surfaces; Ajax Lingettes Désinfectantes Multi-Surfaces | Market area: EU |
| Ajax Ultra 7 Antibakterielle Reinigungstücher; Ajax Antibakterielle Reinigungstücher; Ajax Power Antibakterielle Reinigungstücher | Market area: EU |
| Ajax Για Όλες τις Επιφάνειες; Ajax Expert Για Όλες τις Επιφάνειες; Ajax Πανάκια Για Όλες τις Επιφάνειες; Πανάκια Ajax Για Όλες τις Επιφάνειες; Ajax Plant Based για Όλες τις Επιφάνειες & Απολυμαντικό | Market area: EU |
| Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface | Market area: EU |
| Ajax Salviettine Multiuso; Salviette Ajax Plant Based Multiuso | Market area: EU |
| Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface | Market area: EU |
| Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface | Market area: EU |
| Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface | Market area: EU |
| Toalhitas Ajax Multiusos Frescura Intensa; Ajax Plant Based Multiusos & Ação Antibacteriana | Market area: EU |
| Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface | Market area: EU |
| Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface | Market area: EU |
| Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface | Market area: EU |
| Ajax Toallitas Multiusos | Market area: EU |
| Ajax antibakterielle Allzweck-Tücher/Ajax lingettes nettoyantes antibactériennes Multi-Usages | Market area: EU |
| Ajax Antibacterial Wipes Intense Freshness | Market area: EU |
| Ajax Antibacterial Wipes Multisurface; Ajax Lingettes Antibactériennes Multi-Surfaces/Ajax Antibacteriële Doekjes Multi-Oppervlakken; Ajax Lingettes Désinfectantes Multi-Surfaces/Ajax Desinfecterende Doekjes Multi-Oppervlakken | Market area: EU |
| Ajax Antibacterial Wipes Multisurface; Ajax Antibacteriële Doekjes Multi-Oppervlakken; Ajax Desinfecterende Doekjes Multi-Oppervlakken | Market area: EU |
| Authorisation number | EU-0028421-0011 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 3,67 |
| Propan-2-ol | | Non-active substance | 67-63-0 | 200-661-7 | 0,1 |

Trade name(s)

B023-1873-0006

Market area: EU

Ajax Optimal 7 Wipes Multisurfaces @ 3,5 % (ref B023-1873-0006)

Market area: EU

Ajax Ultra 7 Antibakterielle Reinigungstücher; Ajax Antibakterielle Reinigungstücher; Ajax Power Antibakterielle Reinigungstücher

Market area: EU

Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface

Market area: EU

Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface

Market area: EU

Ajax Expert Για Όλες τις Επιφάνειες; Ajax Πανάκια Για Όλες τις Επιφάνειες; Πανάκια Ajax Για Όλες τις Επιφάνειες; Ajax Plant Based για Όλες τις Επιφάνειες & Απολυμαντικό

Market area: EU

Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface

Market area: EU

Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface

Market area: EU

Ajax Optimal 7 Surfaces Grasses Antibactérien; Ajax Surfaces Grasses; Ajax Power; Ajax Multisurfaces, Ajax Lingettes Antibactériennes Multi-Surfaces; Ajax Lingettes Désinfectantes Multi-Surfaces

Market area: EU

Ajax Ultra 7 Antibakterielle Reinigungstücher; Ajax Antibakterielle Reinigungstücher; Ajax Power Antibakterielle Reinigungstücher

Market area: EU

Ajax Για Όλες τις Επιφάνειες; Ajax Expert Για Όλες τις Επιφάνειες; Ajax Πανάκια Για Όλες τις Επιφάνειες; Πανάκια Ajax Για Όλες τις Επιφάνειες; Ajax Plant Based για Όλες τις Επιφάνειες & Απολυμαντικό

Market area: EU

Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface

Market area: EU

Ajax Salviettine Multiuso; Salviette Ajax Plant Based Multiuso

Market area: EU

Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface

Market area: EU

Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface

Market area: EU

Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface

Market area: EU

Toalhitas Ajax Multiusos Frescura Intensa; Ajax Plant Based Multiusos & Ação Antibacteriana

Market area: EU

Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface

Market area: EU

Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface

Market area: EU

Ajax Power Multipurpose; Ajax Multipurpose; Ajax Multisurface

Market area: EU

Ajax Toallitas Multiusos

Market area: EU

Ajax antibakterielle Allzweck-Tücher/Ajax lingettes nettoyantes antibactériennes Multi-Usages

Market area: EU

Ajax Antibacterial Wipes Intense Freshness

Market area: EU

Ajax Antibacterial Wipes Multisurface; Ajax Lingettes Antibactériennes Multi-Surfaces/Ajax Antibacteriële Doekjes Multi-Oppervlakken; Ajax Lingettes Désinfectantes Multi-Surfaces/Ajax Desinfecterende Doekjes Multi-Oppervlakken

Market area: EU

Ajax Antibacterial Wipes Multisurface; Ajax Antibacteriële Doekjes Multi-Oppervlakken; Ajax Desinfecterende Doekjes Multi-Oppervlakken

Market area: EU

Authorisation number

EU-0028421-0011 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

3,67

Propan-2-ol

Non-active substance

67-63-0

200-661-7

0,1

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

| Trade name(s) | B023-1873-0005 | Market area: EU |
| --- | --- | --- |
| Ajax Optimal 7 Wipes Multisurfaces @ 4 % (ref B023-1873-0005) | Market area: EU |
| Ajax Για Όλες τις Επιφάνειες + (Plus); Ajax Expert Για Όλες τις Επιφάνειες + (Plus); Ajax Πανάκια Για Όλες τις Επιφάνειες + (Plus); Πανάκια Ajax Για Όλες τις Επιφάνειες + (Plus); Ajax Plant Based για Όλες τις Επιφάνειες & Απολυμαντικό | Market area: EU |
| Ajax Για Όλες τις Επιφάνειες + (Plus); Ajax Expert Για Όλες τις Επιφάνειες + (Plus); Ajax Πανάκια Για Όλες τις Επιφάνειες + (Plus); Πανάκια Ajax Για Όλες τις Επιφάνειες + (Plus); Ajax Plant Based για Όλες τις Επιφάνειες & Απολυμαντικό | Market area: EU |
| Ajax Salviettine Multiuso; Ajax Optimal 7 Salviettine Multiuso+; Ajax Salviettine Multiuso+; Salviette Ajax Plant Base Multisup | Market area: EU |
| Toalhitas Ajax Multiusos Frescura Intensa + (Plus); Ajax Plant Based Multiusos & Ação Antibacteriana | Market area: EU |
| Ajax Toallitas Multiusos + (Plus) | Market area: EU |
| Ajax antibakterielle Allzweck-Tücher/Ajax lingettes nettoyantes antibactériennes Multi-Usages | Market area: EU |
| Ajax Antibacterial Wipes Intense Freshness Plus | Market area: EU |
| Authorisation number | EU-0028421-0012 1-2 |
| Common name | IUPAC name | Function | CAS number | EC number | Content (%) |
| L-(+)-lactic acid | | Active Substance | 79-33-4 | 201-196-2 | 4,19 |
| Propan-2-ol | | Non-active substance | 67-63-0 | 200-661-7 | 0,1 |

Trade name(s)

B023-1873-0005

Market area: EU

Ajax Optimal 7 Wipes Multisurfaces @ 4 % (ref B023-1873-0005)

Market area: EU

Ajax Για Όλες τις Επιφάνειες + (Plus); Ajax Expert Για Όλες τις Επιφάνειες + (Plus); Ajax Πανάκια Για Όλες τις Επιφάνειες + (Plus); Πανάκια Ajax Για Όλες τις Επιφάνειες + (Plus); Ajax Plant Based για Όλες τις Επιφάνειες & Απολυμαντικό

Market area: EU

Ajax Για Όλες τις Επιφάνειες + (Plus); Ajax Expert Για Όλες τις Επιφάνειες + (Plus); Ajax Πανάκια Για Όλες τις Επιφάνειες + (Plus); Πανάκια Ajax Για Όλες τις Επιφάνειες + (Plus); Ajax Plant Based για Όλες τις Επιφάνειες & Απολυμαντικό

Market area: EU

Ajax Salviettine Multiuso; Ajax Optimal 7 Salviettine Multiuso+; Ajax Salviettine Multiuso+; Salviette Ajax Plant Base Multisup

Market area: EU

Toalhitas Ajax Multiusos Frescura Intensa + (Plus); Ajax Plant Based Multiusos & Ação Antibacteriana

Market area: EU

Ajax Toallitas Multiusos + (Plus)

Market area: EU

Ajax antibakterielle Allzweck-Tücher/Ajax lingettes nettoyantes antibactériennes Multi-Usages

Market area: EU

Ajax Antibacterial Wipes Intense Freshness Plus

Market area: EU

Authorisation number

EU-0028421-0012 1-2

Common name

IUPAC name

Function

CAS number

EC number

Content (%)

L-(+)-lactic acid

Active Substance

79-33-4

201-196-2

4,19

Propan-2-ol

Non-active substance

67-63-0

200-661-7

0,1

---

(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.

---

DECISIONS

| 17.11.2022 | EN | Official Journal of the European Union | L 297/69 |
| --- | --- | --- | --- |

17.11.2022

EN

Official Journal of the European Union

L 297/69

---

COUNCIL IMPLEMENTING DECISION (EU) 2022/2254

of 14 November 2022

authorising Bulgaria to introduce a special measure derogating from Article 287 of Directive 2006/112/EC on the common system of value added tax

THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (1), and in particular Article 395(1) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | Article 287, point (17), of Directive 2006/112/EC allows Bulgaria to exempt from value added tax (VAT) taxable persons whose annual turnover is no higher than the equivalent in national currency of EUR 25 600 at the conversion rate on the day of its accession. |
| --- | --- |

(1)

Article 287, point (17), of Directive 2006/112/EC allows Bulgaria to exempt from value added tax (VAT) taxable persons whose annual turnover is no higher than the equivalent in national currency of EUR 25 600 at the conversion rate on the day of its accession.

| (2) | By letter registered with the Commission on 17 May 2022, Bulgaria requested an authorisation to introduce a special measure derogating from Article 287, point (17), of Directive 2006/112/EC and thus to exempt from VAT taxable persons whose annual turnover is no higher than the equivalent in national currency of EUR 51 130 at the conversion rate on the day of its accession (‘the special measure’). The special measure would be applicable until 31 December 2024, the date by which Member States are to transpose Council Directive (EU) 2020/285 (2). It follows from that Directive that, from 1 January 2025, Member States will be allowed to exempt from VAT the supply of goods and services made by taxable persons whose annual turnover in a given Member State does not exceed a threshold of EUR 85 000 or the equivalent in national currency. |
| --- | --- |

(2)

By letter registered with the Commission on 17 May 2022, Bulgaria requested an authorisation to introduce a special measure derogating from Article 287, point (17), of Directive 2006/112/EC and thus to exempt from VAT taxable persons whose annual turnover is no higher than the equivalent in national currency of EUR 51 130 at the conversion rate on the day of its accession (‘the special measure’). The special measure would be applicable until 31 December 2024, the date by which Member States are to transpose Council Directive (EU) 2020/285 (2). It follows from that Directive that, from 1 January 2025, Member States will be allowed to exempt from VAT the supply of goods and services made by taxable persons whose annual turnover in a given Member State does not exceed a threshold of EUR 85 000 or the equivalent in national currency.

| (3) | Pursuant to Article 395(2), second subparagraph, of Directive 2006/112/EC, the Commission transmitted the request made by Bulgaria to the other Member States, by letter of 26 July 2022. By letter of 27 July 2022, the Commission notified Bulgaria that it had all the information necessary for the appraisal of the request. |
| --- | --- |

(3)

Pursuant to Article 395(2), second subparagraph, of Directive 2006/112/EC, the Commission transmitted the request made by Bulgaria to the other Member States, by letter of 26 July 2022. By letter of 27 July 2022, the Commission notified Bulgaria that it had all the information necessary for the appraisal of the request.

| (4) | The special measure is in line with Directive (EU) 2020/285, which seeks to reduce the compliance burden of small enterprises and avoid distortions of competition in the internal market. |
| --- | --- |

(4)

The special measure is in line with Directive (EU) 2020/285, which seeks to reduce the compliance burden of small enterprises and avoid distortions of competition in the internal market.

| (5) | The special measure will remain optional for taxable persons as they may still opt for the normal VAT arrangements pursuant to Article 290 of Directive 2006/112/EC. |
| --- | --- |

(5)

The special measure will remain optional for taxable persons as they may still opt for the normal VAT arrangements pursuant to Article 290 of Directive 2006/112/EC.

| (6) | According to the information provided by Bulgaria, the special measure will only have a negligible effect on the overall amount of tax revenue Bulgaria collects at the stage of final consumption. |
| --- | --- |

(6)

According to the information provided by Bulgaria, the special measure will only have a negligible effect on the overall amount of tax revenue Bulgaria collects at the stage of final consumption.

| (7) | Following the entry into force of Council Regulation (EU, Euratom) 2021/769 (3), there is to be no compensation calculation carried out by Bulgaria with regard to the VAT-based own resource statement for the financial year 2022 onwards. |
| --- | --- |

(7)

Following the entry into force of Council Regulation (EU, Euratom) 2021/769 (3), there is to be no compensation calculation carried out by Bulgaria with regard to the VAT-based own resource statement for the financial year 2022 onwards.

| (8) | Given that Bulgaria expects that the special measure will result in reduced VAT obligations and thus a reduction in the administrative burden and compliance costs for both small enterprises and the tax authorities, and given the lack of any major impact on the total VAT revenue generated, Bulgaria should be authorised to introduce the special measure. |
| --- | --- |

(8)

Given that Bulgaria expects that the special measure will result in reduced VAT obligations and thus a reduction in the administrative burden and compliance costs for both small enterprises and the tax authorities, and given the lack of any major impact on the total VAT revenue generated, Bulgaria should be authorised to introduce the special measure.

| (9) | The application of the special measure should be limited in time. The time limit should be sufficient to allow the Commission to evaluate the effectiveness and appropriateness of the threshold. Moreover, pursuant to Article 3(1) of Directive (EU) 2020/285, Member States are to adopt and publish, by 31 December 2024, the laws, regulations and administrative provisions necessary to comply with Article 1 of that Directive, which amends Directive 2006/112/EC and lays down simpler VAT rules for small enterprises, and apply those provisions from 1 January 2025. It is therefore appropriate to authorise Bulgaria to apply the special measure until 31 December 2024, |
| --- | --- |

(9)

The application of the special measure should be limited in time. The time limit should be sufficient to allow the Commission to evaluate the effectiveness and appropriateness of the threshold. Moreover, pursuant to Article 3(1) of Directive (EU) 2020/285, Member States are to adopt and publish, by 31 December 2024, the laws, regulations and administrative provisions necessary to comply with Article 1 of that Directive, which amends Directive 2006/112/EC and lays down simpler VAT rules for small enterprises, and apply those provisions from 1 January 2025. It is therefore appropriate to authorise Bulgaria to apply the special measure until 31 December 2024,

HAS ADOPTED THIS DECISION:

Article 1

By way of derogation from Article 287, point (17), of Directive 2006/112/EC, Bulgaria is authorised to exempt from VAT taxable persons whose annual turnover is no higher than the equivalent in national currency of EUR 51 130 at the conversion rate on the day of its accession.

Article 2

This Decision shall take effect on the date of its notification.

It shall apply until 31 December 2024.

Article 3

This Decision is addressed to Bulgaria.

Done at Brussels, 14 November 2022.

For the Council

The President

J. BORRELL FONTELLES

---

(1)  
  OJ L 347, 11.12.2006, p. 1.

1

(2)  Council Directive (EU) 2020/285 of 18 February 2020 amending Directive 2006/112/EC on the common system of value added tax as regards the special scheme for small enterprises and Regulation (EU) No 904/2010 as regards the administrative cooperation and exchange of information for the purpose of monitoring the correct application of the special scheme for small enterprises (OJ L 62, 2.3.2020, p. 13).

2

(3)  Council Regulation (EU, Euratom) 2021/769 of 30 April 2021 amending Regulation (EEC, Euratom) No 1553/89 on the definitive uniform arrangements for the collection of own resources accruing from value added tax (OJ L 165, 11.5.2021, p. 9).

3

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| 17.11.2022 | EN | Official Journal of the European Union | L 297/71 |
| --- | --- | --- | --- |

17.11.2022

EN

Official Journal of the European Union

L 297/71

---

COMMISSION DECISION (EU) 2022/2255

of 24 October 2022

on the initiation of the detailed examination of certain performance targets contained in the revised draft performance plan for the third reference period submitted at functional airspace block level by Belgium, Germany, France, Luxembourg, and the Netherlands pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council

(notified under document C(2022) 7438)

(Only the Dutch, French and German texts are authentic)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (1) (the framework Regulation), and in particular Article 11(3) point (c), second paragraphs, thereof,

Having regard to Commission Implementing Regulation (EU) 2019/317 of 11 February 2019 laying down a performance and charging scheme in the single European sky and repealing Implementing Regulations (EU) No 390/2013 and (EU) No 391/2013 (2), and in particular Article 15(1) and (3) thereof,

Whereas:

GENERAL CONSIDERATIONS

GENERAL CONSIDERATIONS

| (1) | Pursuant to Article 10 of Implementing Regulation (EU) 2019/317, Member States are to draw up, either at national level or at the level of functional airspace blocks (‘FABs’), binding performance targets for each reference period of the performance scheme for air navigation services and network functions. Those performance targets have to be consistent with the Union-wide targets adopted by the Commission for the reference period concerned. |
| --- | --- |

(1)

Pursuant to Article 10 of Implementing Regulation (EU) 2019/317, Member States are to draw up, either at national level or at the level of functional airspace blocks (‘FABs’), binding performance targets for each reference period of the performance scheme for air navigation services and network functions. Those performance targets have to be consistent with the Union-wide targets adopted by the Commission for the reference period concerned.

| (2) | Union-wide performance targets for the third reference period (‘RP3’) were originally set out in Commission Implementing Decision (EU) 2019/903 (3). As those Union-wide performance targets and the draft RP3 performance plans subsequently submitted in October 2019 by Member States were drawn up before the outbreak of the COVID-19 pandemic in March 2020, they did not take account of the considerable reduction in air traffic due to the measures taken by the Member States and third countries to contain the pandemic. |
| --- | --- |

(2)

Union-wide performance targets for the third reference period (‘RP3’) were originally set out in Commission Implementing Decision (EU) 2019/903 (3). As those Union-wide performance targets and the draft RP3 performance plans subsequently submitted in October 2019 by Member States were drawn up before the outbreak of the COVID-19 pandemic in March 2020, they did not take account of the considerable reduction in air traffic due to the measures taken by the Member States and third countries to contain the pandemic.

3

| (3) | In response to the impact of the COVID-19 pandemic on the provision of air navigation services, exceptional measures for RP3, which derogate from the provisions of Implementing Regulation (EU) 2019/317, were set out in Commission Implementing Regulation (EU) 2020/1627 (4). The Commission adopted, on 2 June 2021, Implementing Decision (EU) 2021/891 (5) setting revised Union-wide performance targets for RP3. On this basis, Member States submitted to the Commission, in October 2021, draft performance plans containing revised local performance targets for RP3. |
| --- | --- |

(3)

In response to the impact of the COVID-19 pandemic on the provision of air navigation services, exceptional measures for RP3, which derogate from the provisions of Implementing Regulation (EU) 2019/317, were set out in Commission Implementing Regulation (EU) 2020/1627 (4). The Commission adopted, on 2 June 2021, Implementing Decision (EU) 2021/891 (5) setting revised Union-wide performance targets for RP3. On this basis, Member States submitted to the Commission, in October 2021, draft performance plans containing revised local performance targets for RP3.

4

5

| (4) | Commission Implementing Decision (EU) 2022/728 (6) on the inconsistency of certain performance targets contained in the draft national and functional airspace block performance plans was addressed to Belgium, Germany, Greece, France, Cyprus, Latvia, Luxembourg, Malta, the Netherlands, Romania, and Sweden. |
| --- | --- |

(4)

Commission Implementing Decision (EU) 2022/728 (6) on the inconsistency of certain performance targets contained in the draft national and functional airspace block performance plans was addressed to Belgium, Germany, Greece, France, Cyprus, Latvia, Luxembourg, Malta, the Netherlands, Romania, and Sweden.

6

| (5) | In respect of the draft performance plan for RP3 established at functional airspace block level by Belgium, Germany, France, Luxembourg, and the Netherlands (‘draft FABEC performance plan’), the Commission found that the cost-efficiency performance targets for the Belgium-Luxembourg en route charging zone are not consistent with the Union-wide performance targets and issued recommendations for the revision of those targets. |
| --- | --- |

(5)

In respect of the draft performance plan for RP3 established at functional airspace block level by Belgium, Germany, France, Luxembourg, and the Netherlands (‘draft FABEC performance plan’), the Commission found that the cost-efficiency performance targets for the Belgium-Luxembourg en route charging zone are not consistent with the Union-wide performance targets and issued recommendations for the revision of those targets.

en route

| (6) | In response to Russia’s war of aggression against Ukraine, which started on 24 February 2022, the Union has imposed restrictive measures which prohibit Russian air carriers, any Russian-registered aircraft and any non-Russian-registered aircraft which is owned or chartered, or otherwise controlled by any Russian natural or legal person, entity or body, from landing in and taking off from, or overflying the territory of the Union. Those restrictive measures and the counter-measures adopted by Russia have led to changes in air traffic in European airspace. Certain Member States have been severely affected by a significant reduction in the number of overflights in the airspace under their responsibility. However, at Union-wide level, the observed impact of those measures on the number of flights has been limited, which is in contrast with the sharp reduction of air traffic across Europe that resulted from the outbreak of the COVID-19 pandemic. |
| --- | --- |

(6)

In response to Russia’s war of aggression against Ukraine, which started on 24 February 2022, the Union has imposed restrictive measures which prohibit Russian air carriers, any Russian-registered aircraft and any non-Russian-registered aircraft which is owned or chartered, or otherwise controlled by any Russian natural or legal person, entity or body, from landing in and taking off from, or overflying the territory of the Union. Those restrictive measures and the counter-measures adopted by Russia have led to changes in air traffic in European airspace. Certain Member States have been severely affected by a significant reduction in the number of overflights in the airspace under their responsibility. However, at Union-wide level, the observed impact of those measures on the number of flights has been limited, which is in contrast with the sharp reduction of air traffic across Europe that resulted from the outbreak of the COVID-19 pandemic.

| (7) | Belgium, Germany, France, Luxembourg, and the Netherlands submitted, on 13 July 2022, a revised draft FABEC performance plan for RP3 for assessment by the Commission. |
| --- | --- |

(7)

Belgium, Germany, France, Luxembourg, and the Netherlands submitted, on 13 July 2022, a revised draft FABEC performance plan for RP3 for assessment by the Commission.

| (8) | The performance review body, assisting the Commission in the implementation of the performance scheme pursuant to Article 11(2) of Regulation (EC) No 549/2004, has submitted to the Commission a report containing its advice on the assessment of the revised draft FABEC performance plan. |
| --- | --- |

(8)

The performance review body, assisting the Commission in the implementation of the performance scheme pursuant to Article 11(2) of Regulation (EC) No 549/2004, has submitted to the Commission a report containing its advice on the assessment of the revised draft FABEC performance plan.

| (9) | In accordance with Article 15(1) of Implementing Regulation (EU) 2019/317, the Commission has assessed the consistency of the local performance targets contained in the revised draft FABEC performance plan on the basis of the assessment criteria laid down in point 1 of Annex IV to that Implementing Regulation, and taking account of local circumstances. In respect of each key performance area and the related performance targets, the Commission has complemented its assessment by reviewing the elements set out in point 2 of Annex IV to that Implementing Regulation. |
| --- | --- |

(9)

In accordance with Article 15(1) of Implementing Regulation (EU) 2019/317, the Commission has assessed the consistency of the local performance targets contained in the revised draft FABEC performance plan on the basis of the assessment criteria laid down in point 1 of Annex IV to that Implementing Regulation, and taking account of local circumstances. In respect of each key performance area and the related performance targets, the Commission has complemented its assessment by reviewing the elements set out in point 2 of Annex IV to that Implementing Regulation.

| (10) | The Eurocontrol STATFOR base traffic forecast published in June 2022 takes account of the changed circumstances referred to in recital (6). Based on that forecast, the Commission notes that Belgium, Germany, France, Luxembourg, and the Netherlands are not foreseen to experience major changes in air traffic flows over RP3 as a result of Russia’s war in Ukraine. Therefore, those changed circumstances do not directly impact the performance targets contained in the revised draft FABEC performance plan or the assessment of those targets in respect of their consistency with the Union-wide performance targets. |
| --- | --- |

(10)

The Eurocontrol STATFOR base traffic forecast published in June 2022 takes account of the changed circumstances referred to in recital (6). Based on that forecast, the Commission notes that Belgium, Germany, France, Luxembourg, and the Netherlands are not foreseen to experience major changes in air traffic flows over RP3 as a result of Russia’s war in Ukraine. Therefore, those changed circumstances do not directly impact the performance targets contained in the revised draft FABEC performance plan or the assessment of those targets in respect of their consistency with the Union-wide performance targets.

REASONS FOR INITIATING A DETAILED EXAMINATION

REASONS FOR INITIATING A DETAILED EXAMINATION

Performance targets giving rise to doubts

Performance targets giving rise to doubts

| (11) | The table below shows the initial RP3 en route cost-efficiency performance targets for the Belgium-Luxembourg charging zone, as contained in the draft FABEC performance plan submitted in 2021, and the corresponding revised performance targets contained in the revised draft FABEC performance plan submitted in July 2022.













  En route charging zone of Belgium-Luxembourg | 2014 baseline value | 2019 baseline value | 2020-2021 | 2022 | 2023 | 2024 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Initial en route cost-efficiency targets (contained in the draft FABEC performance plan submitted in 2021), expressed as determined en route unit cost (in real terms in 2017 prices) | 73,13 EUR | 83,28 EUR | 189,52 EUR | 113,26 EUR | 108,51 EUR | 103,82 EUR |
| Revised en route cost-efficiency targets (contained in the revised draft FABEC performance plan), expressed as determined en route unit cost (in real terms in 2017 prices) | 81,78 EUR | 83,26 EUR | 189,52 EUR | 104,47 EUR | 94,18 EUR | 89,87 EUR |

(11)

The table below shows the initial RP3 en route cost-efficiency performance targets for the Belgium-Luxembourg charging zone, as contained in the draft FABEC performance plan submitted in 2021, and the corresponding revised performance targets contained in the revised draft FABEC performance plan submitted in July 2022.

en route

En route charging zone of Belgium-Luxembourg

En route

2014 baseline value

2014 baseline value

2019 baseline value

2019 baseline value

2020-2021

2020-2021

2022

2022

2023

2023

2024

2024

Initial en route cost-efficiency targets (contained in the draft FABEC performance plan submitted in 2021), expressed as determined en route unit cost (in real terms in 2017 prices)

Initial en route cost-efficiency targets (contained in the draft FABEC performance plan submitted in 2021), expressed as determined en route unit cost (in real terms in 2017 prices)

73,13 EUR

73,13 EUR

83,28 EUR

83,28 EUR

189,52 EUR

189,52 EUR

113,26 EUR

113,26 EUR

108,51 EUR

108,51 EUR

103,82 EUR

103,82 EUR

Revised en route cost-efficiency targets (contained in the revised draft FABEC performance plan), expressed as determined en route unit cost (in real terms in 2017 prices)

Revised en route

en route

81,78 EUR

81,78 EUR

83,26 EUR

83,26 EUR

189,52 EUR

189,52 EUR

104,47 EUR

104,47 EUR

94,18 EUR

94,18 EUR

89,87 EUR

89,87 EUR

| (12) | The Commission notes that the performance targets for calendar years 2022, 2023 and 2024 have been revised downwards, whilst the baseline value for 2014 has been revised upwards. Furthermore, a minor technical adjustment, which is not of significance for the assessment of the performance targets, has been applied with regard to the baseline value for 2019. |
| --- | --- |

(12)

The Commission notes that the performance targets for calendar years 2022, 2023 and 2024 have been revised downwards, whilst the baseline value for 2014 has been revised upwards. Furthermore, a minor technical adjustment, which is not of significance for the assessment of the performance targets, has been applied with regard to the baseline value for 2019.

| (13) | Belgium and Luxembourg have justified the proposed adjustment of the baseline value for 2014 mainly by the changes in the cost allocation methodology between en route and terminal services, which were introduced in RP3. A similar adjustment has been applied for the 2019 baseline value and was already included in the draft FABEC performance plan submitted in 2021. |
| --- | --- |

(13)

Belgium and Luxembourg have justified the proposed adjustment of the baseline value for 2014 mainly by the changes in the cost allocation methodology between en route and terminal services, which were introduced in RP3. A similar adjustment has been applied for the 2019 baseline value and was already included in the draft FABEC performance plan submitted in 2021.

en route

| (14) | The Commission observes that the revision of cost-efficiency targets for the time period from 2022 to 2024 leads to an overall determined unit cost (‘DUC’) reduction of -11,6 % over those three calendar years and of -8,2 % over RP3 as a whole. Those DUC reductions result both from the updated traffic assumptions used in the revised draft performance plan and from the downward revision of the determined costs expressed in real terms in 2017 prices. |
| --- | --- |

(14)

The Commission observes that the revision of cost-efficiency targets for the time period from 2022 to 2024 leads to an overall determined unit cost (‘DUC’) reduction of -11,6 % over those three calendar years and of -8,2 % over RP3 as a whole. Those DUC reductions result both from the updated traffic assumptions used in the revised draft performance plan and from the downward revision of the determined costs expressed in real terms in 2017 prices.

| (15) | The changes to the traffic forecast for calendar years 2022 to 2024 are presented in the table below. The Commission notes that the traffic forecast used in the revised draft performance plan is based on the Eurocontrol STATFOR June 2022 base traffic forecast.










  En route charging zone of Belgium-Luxembourg | 2022 | 2023 | 2024 |
| --- | --- | --- | --- | --- |
| Initial traffic forecast (contained in the draft performance plan submitted in 2021), expressed in thousands of en route service units | 2 066 | 2 226 | 2 387 |
| Updated traffic forecast (contained in the revised draft performance plan), expressed in thousands of en route service units | 2 108 | 2 445 | 2 542 |
| Difference | +2,0  % | +9,8  % | +6,5  % |

(15)

The changes to the traffic forecast for calendar years 2022 to 2024 are presented in the table below. The Commission notes that the traffic forecast used in the revised draft performance plan is based on the Eurocontrol STATFOR June 2022 base traffic forecast.

En route charging zone of Belgium-Luxembourg

En route

2022

2022

2023

2023

2024

2024

Initial traffic forecast (contained in the draft performance plan submitted in 2021), expressed in thousands of en route service units

Initial traffic forecast (contained in the draft performance plan submitted in 2021), expressed in thousands of en route service units

2 066

2 066

2 226

2 226

2 387

2 387

Updated traffic forecast (contained in the revised draft performance plan), expressed in thousands of en route service units

Updated traffic forecast (contained in the revised draft performance plan)

2 108

2 108

2 445

2 445

2 542

2 542

Difference

Difference

+2,0  %

+2,0  %

+9,8  %

+9,8  %

+6,5  %

+6,5  %

| (16) | The revised determined costs for calendar years 2022 to 2024, expressed in real terms in 2017 prices, are shown in the table below.










  En route charging zone of Belgium-Luxembourg | 2022 | 2023 | 2024 |
| --- | --- | --- | --- | --- |
| Initial determined costs in real terms in 2017 prices (contained in the draft performance plan submitted in 2021) | 234 M EUR | 242 M EUR | 248 M EUR |
| Revised determined costs in real terms in 2017 prices (contained in the revised draft performance plan) | 220 M EUR | 230 M EUR | 228 M EUR |
| Difference | -5,9  % | -4,7  % | -7,8  % |

(16)

The revised determined costs for calendar years 2022 to 2024, expressed in real terms in 2017 prices, are shown in the table below.

En route charging zone of Belgium-Luxembourg

En route

2022

2022

2023

2023

2024

2024

Initial determined costs in real terms in 2017 prices (contained in the draft performance plan submitted in 2021)

Initial determined costs in real terms in 2017 prices (contained in the draft performance plan submitted in 2021)

234 M EUR

234 M EUR

242 M EUR

242 M EUR

248 M EUR

248 M EUR

Revised determined costs in real terms in 2017 prices (contained in the revised draft performance plan)

Revised determined costs in real terms in 2017 prices

220 M EUR

220 M EUR

230 M EUR

230 M EUR

228 M EUR

228 M EUR

Difference

Difference

-5,9  %

-5,9  %

-4,7  %

-4,7  %

-7,8  %

-7,8  %

| (17) | The Commission notes that inflation assumptions underlying the setting of determined costs have been revised significantly upwards, as outlined in the table below.










  En route charging zone of Belgium-Luxembourg | 2022 | 2023 | 2024 |
| --- | --- | --- | --- | --- |
| Initial inflation index, with forecasted year-on-year change in inflation in parenthesis (data contained in the draft performance plan submitted in 2021) | 107,7


  (1,9  %) | 109,7


  (1,8  %) | 111,6


  (1,8  %) |
| Revised inflation index, with year-on-year change in inflation in parenthesis (data contained in the revised draft performance plan) | 115,6


  (7,8  %) | 119,6


  (3,4  %) | 121,8


  (1,9  %) |

(17)

The Commission notes that inflation assumptions underlying the setting of determined costs have been revised significantly upwards, as outlined in the table below.

En route charging zone of Belgium-Luxembourg

En route

2022

2022

2023

2023

2024

2024

Initial inflation index, with forecasted year-on-year change in inflation in parenthesis (data contained in the draft performance plan submitted in 2021)

Initial inflation index, with forecasted year-on-year change in inflation in parenthesis (data contained in the draft performance plan submitted in 2021)

107,7

107,7

(1,9  %)

(1,9  %)

109,7

109,7

(1,8  %)

(1,8  %)

111,6

111,6

(1,8  %)

(1,8  %)

Revised inflation index, with year-on-year change in inflation in parenthesis (data contained in the revised draft performance plan)

Revised inflation index, with year-on-year change in inflation in parenthesis (data contained in the revised draft performance plan)

115,6

115,6

(7,8  %)

(7,8  %)

119,6

119,6

(3,4  %)

(3,4  %)

121,8

121,8

(1,9  %)

(1,9  %)

| (18) | Due to the update of the inflation forecast, the revised determined costs in nominal terms for calendar years 2022 to 2024, which are displayed below, remain largely unchanged and are even increased by +2,9 % for calendar year 2023, despite being lower in real terms as presented in recital (16).










  En route charging zone of Belgium-Luxembourg | 2022 | 2023 | 2024 |
| --- | --- | --- | --- | --- |
| Initial determined costs in nominal terms (contained in the draft performance plan submitted in 2021) | 250 M EUR | 262 M EUR | 273 M EUR |
| Revised determined costs in nominal terms (contained in the revised draft performance plan) | 250 M EUR | 269 M EUR | 272 M EUR |
| Difference | +0,1  % | +2,9  % | -0,3  % |

(18)

Due to the update of the inflation forecast, the revised determined costs in nominal terms for calendar years 2022 to 2024, which are displayed below, remain largely unchanged and are even increased by +2,9 % for calendar year 2023, despite being lower in real terms as presented in recital (16).

En route charging zone of Belgium-Luxembourg

En route

2022

2022

2023

2023

2024

2024

Initial determined costs in nominal terms (contained in the draft performance plan submitted in 2021)

Initial determined costs in nominal terms (contained in the draft performance plan submitted in 2021)

250 M EUR

250 M EUR

262 M EUR

262 M EUR

273 M EUR

273 M EUR

Revised determined costs in nominal terms (contained in the revised draft performance plan)

Revised determined costs in nominal terms

250 M EUR

250 M EUR

269 M EUR

269 M EUR

272 M EUR

272 M EUR

Difference

Difference

+0,1  %

+0,1  %

+2,9  %

+2,9  %

-0,3  %

-0,3  %

| (19) | The Commission further observes that the determined costs for 2024 include a one-off reduction amounting to approximately EUR 8,3M in nominal terms. |
| --- | --- |

(19)

The Commission further observes that the determined costs for 2024 include a one-off reduction amounting to approximately EUR 8,3M in nominal terms.

| (20) | The Commission notes that three air navigation service providers, namely skeyes, MUAC and ANA Luxembourg, are included in the scope of the Belgium-Luxembourg en route charging zone. With regard to the costs of service provision in the charging zone, 62 % of the determined costs of 2024 are incurred by skeyes, whilst MUAC represents 35 % of the cost base for that same year. Only 3 % of the total costs of service provision in the charging zone are allocated to ANA Luxembourg, and those costs are exclusively incurred for the provision of approach services in the airspace around Luxembourg airport. |
| --- | --- |

(20)

The Commission notes that three air navigation service providers, namely skeyes, MUAC and ANA Luxembourg, are included in the scope of the Belgium-Luxembourg en route charging zone. With regard to the costs of service provision in the charging zone, 62 % of the determined costs of 2024 are incurred by skeyes, whilst MUAC represents 35 % of the cost base for that same year. Only 3 % of the total costs of service provision in the charging zone are allocated to ANA Luxembourg, and those costs are exclusively incurred for the provision of approach services in the airspace around Luxembourg airport.

en route

Findings

Findings

| (21) | The Commission has assessed the consistency of the revised cost-efficiency targets proposed for the Belgium-Luxembourg en route charging zone based on the criteria laid down in points 1.4(a), (b) and (c) of Annex IV to Implementing Regulation (EU) 2019/317. |
| --- | --- |

(21)

The Commission has assessed the consistency of the revised cost-efficiency targets proposed for the Belgium-Luxembourg en route charging zone based on the criteria laid down in points 1.4(a), (b) and (c) of Annex IV to Implementing Regulation (EU) 2019/317.

en route

| (22) | Concerning the criterion laid down in point 1.4(a) of Annex IV to Implementing Regulation (EU) 2019/317, the Commission observes that the en route DUC trend at charging zone level of +1,9 % over RP3 underperforms the Union-wide trend of +1,0 % over the same period. The Commission notes that this constitutes an improvement from the DUC trend of +5,7 % calculated on the basis of the draft FABEC performance plan submitted in 2021. |
| --- | --- |

(22)

Concerning the criterion laid down in point 1.4(a) of Annex IV to Implementing Regulation (EU) 2019/317, the Commission observes that the en route DUC trend at charging zone level of +1,9 % over RP3 underperforms the Union-wide trend of +1,0 % over the same period. The Commission notes that this constitutes an improvement from the DUC trend of +5,7 % calculated on the basis of the draft FABEC performance plan submitted in 2021.

en route

| (23) | Concerning the criterion laid down in point 1.4(b) of Annex IV to Implementing Regulation (EU) 2019/317, the Commission observes that the long-term en route DUC trend at charging zone level over the second reference period (‘RP2’) and RP3 of +1,1 % underperforms the long-term Union-wide trend of -1,3 % over the same period. The Commission notes that this constitutes an improvement from the long-term DUC trend of +4,0 % calculated on the basis of the draft FABEC performance plan submitted in 2021. With reference to recital (13), this improvement is partially due to the adjustment of the baseline value for 2014 for the charging zone. |
| --- | --- |

(23)

Concerning the criterion laid down in point 1.4(b) of Annex IV to Implementing Regulation (EU) 2019/317, the Commission observes that the long-term en route DUC trend at charging zone level over the second reference period (‘RP2’) and RP3 of +1,1 % underperforms the long-term Union-wide trend of -1,3 % over the same period. The Commission notes that this constitutes an improvement from the long-term DUC trend of +4,0 % calculated on the basis of the draft FABEC performance plan submitted in 2021. With reference to recital (13), this improvement is partially due to the adjustment of the baseline value for 2014 for the charging zone.

en route

| (24) | Concerning the criterion laid down in point 1.4(c) of Annex IV to Implementing Regulation (EU) 2019/317, the Commission observes that the baseline value for the DUC of EUR 83,26 of Belgium and Luxembourg in EUR2017 is 13,2 % higher than the average baseline value of 73,53 EUR2017 of the relevant comparator group. The Commission notes that the difference becomes even larger during RP3, as the en route DUC of Belgium and Luxembourg for 2024 is higher by 29,8 % than the average of the comparator group. |
| --- | --- |

(24)

Concerning the criterion laid down in point 1.4(c) of Annex IV to Implementing Regulation (EU) 2019/317, the Commission observes that the baseline value for the DUC of EUR 83,26 of Belgium and Luxembourg in EUR2017 is 13,2 % higher than the average baseline value of 73,53 EUR2017 of the relevant comparator group. The Commission notes that the difference becomes even larger during RP3, as the en route DUC of Belgium and Luxembourg for 2024 is higher by 29,8 % than the average of the comparator group.

en route

| (25) | Furthermore, it is necessary to examine whether the deviations observed in recitals (22) to (24) above from the criteria set out in points 1.4(a), 1.4(b) and 1.4(c) of Annex IV to Implementing Regulation (EU) 2019/317 may be deemed necessary and proportionate under point 1.4(d) of that Annex, provided that the observed deviations from the Union-wide DUC trend and from the long-term Union-wide DUC trend are exclusively due to additional determined costs related to measures necessary to achieve the performance targets in the key performance area of capacity or to restructuring measures within the meaning of Article 2(18) of Implementing Regulation (EU) 2019/317. |
| --- | --- |

(25)

Furthermore, it is necessary to examine whether the deviations observed in recitals (22) to (24) above from the criteria set out in points 1.4(a), 1.4(b) and 1.4(c) of Annex IV to Implementing Regulation (EU) 2019/317 may be deemed necessary and proportionate under point 1.4(d) of that Annex, provided that the observed deviations from the Union-wide DUC trend and from the long-term Union-wide DUC trend are exclusively due to additional determined costs related to measures necessary to achieve the performance targets in the key performance area of capacity or to restructuring measures within the meaning of Article 2(18) of Implementing Regulation (EU) 2019/317.

| (26) | The Commission notes that the difference estimated by the performance review body between the RP3 determined en route costs reported by Belgium and Luxembourg in the revised draft FABEC performance plan and the determined costs that would be required to meet the RP3 Union-wide DUC trend is approximately EUR 8,2 M in EUR2017, whilst a corresponding estimated deviation from the long-term Union-wide trend amounts to approximately EUR 43,7 M in EUR2017. |
| --- | --- |

(26)

The Commission notes that the difference estimated by the performance review body between the RP3 determined en route costs reported by Belgium and Luxembourg in the revised draft FABEC performance plan and the determined costs that would be required to meet the RP3 Union-wide DUC trend is approximately EUR 8,2 M in EUR2017, whilst a corresponding estimated deviation from the long-term Union-wide trend amounts to approximately EUR 43,7 M in EUR2017.

en route

| (27) | Similarly as in the draft FABEC performance plan submitted in 2021, Belgium and Luxembourg continue to contend that airspace complexity is one of the key drivers behind the deviation of the revised draft performance plan from the Union-wide DUC trends. The revised draft FABEC performance plan continues to highlight that the complexity of the Belgium-Luxembourg airspace constitutes a factor increasing the relative workload of air traffic controllers and thus weighting negatively on air traffic controller productivity and on the en route cost base. |
| --- | --- |

(27)

Similarly as in the draft FABEC performance plan submitted in 2021, Belgium and Luxembourg continue to contend that airspace complexity is one of the key drivers behind the deviation of the revised draft performance plan from the Union-wide DUC trends. The revised draft FABEC performance plan continues to highlight that the complexity of the Belgium-Luxembourg airspace constitutes a factor increasing the relative workload of air traffic controllers and thus weighting negatively on air traffic controller productivity and on the en route cost base.

en route

| (28) | However, the Commission notes that Belgium and Luxembourg have not demonstrated, in the revised draft FABEC performance plan, that the complexity of the provision of air navigation services in the charging zone would have increased compared to RP2 or that additional costs would be incurred in RP3 because of a change in the complexity of operations. |
| --- | --- |

(28)

However, the Commission notes that Belgium and Luxembourg have not demonstrated, in the revised draft FABEC performance plan, that the complexity of the provision of air navigation services in the charging zone would have increased compared to RP2 or that additional costs would be incurred in RP3 because of a change in the complexity of operations.

| (29) | In respect of the criterion set out in point 1.4(d)(i) of Annex IV to Implementing Regulation (EU) 2019/317, the Commission notes that Belgium and Luxembourg refer in the revised draft FABEC performance plan to additional determined costs incurred over RP3 by the en route air navigation service providers skeyes and MUAC in relation to measures to increase capacity. |
| --- | --- |

(29)

In respect of the criterion set out in point 1.4(d)(i) of Annex IV to Implementing Regulation (EU) 2019/317, the Commission notes that Belgium and Luxembourg refer in the revised draft FABEC performance plan to additional determined costs incurred over RP3 by the en route air navigation service providers skeyes and MUAC in relation to measures to increase capacity.

en route

| (30) | The Commission observes that seven capacity-related measures for skeyes and MUAC are substantiated in the revised draft FABEC performance plan as a justification for the observed deviation from the Union-wide cost-efficiency trends. Four of those measures were already detailed in the draft FABEC performance plan submitted in 2021, whilst three additional measures specific to MUAC have been included. |
| --- | --- |

(30)

The Commission observes that seven capacity-related measures for skeyes and MUAC are substantiated in the revised draft FABEC performance plan as a justification for the observed deviation from the Union-wide cost-efficiency trends. Four of those measures were already detailed in the draft FABEC performance plan submitted in 2021, whilst three additional measures specific to MUAC have been included.

| (31) | Regarding skeyes, the revised draft FABEC performance plan outlines measures aimed at maintaining appropriate levels of air traffic controller (ATCO) capacity in order to address the ageing of the air traffic controller workforce and the consequent high number of retirements expected during RP3 and the fourth reference period (‘RP4’). |
| --- | --- |

(31)

Regarding skeyes, the revised draft FABEC performance plan outlines measures aimed at maintaining appropriate levels of air traffic controller (ATCO) capacity in order to address the ageing of the air traffic controller workforce and the consequent high number of retirements expected during RP3 and the fourth reference period (‘RP4’).

| (32) | Such measures include in particular the recruitment and training of new air traffic controllers in order to replace the planned retirements and deliver the capacity required by the forecasted traffic. Furthermore, skeyes is reported to incur significant costs in relation to the ‘DISPO-scheme’ which, in accordance with Belgian law (7), requires air traffic controllers to be withdrawn from duty five years before their retirement date. During those five years, they are eligible for pre-retirement and receive an allowance equaling between 75 % and 85 % of their last salary. According to the information provided in the draft performance plan, air traffic controllers are currently placed in DISPO at the age of 56 and this age limit is due to be raised to 57 from 2025 onwards. The Commission notes that no mitigation measures have been presented by Belgium in order to limit the considerable and growing financial impact of the DISPO scheme on the RP3 cost base. |
| --- | --- |

(32)

Such measures include in particular the recruitment and training of new air traffic controllers in order to replace the planned retirements and deliver the capacity required by the forecasted traffic. Furthermore, skeyes is reported to incur significant costs in relation to the ‘DISPO-scheme’ which, in accordance with Belgian law (7), requires air traffic controllers to be withdrawn from duty five years before their retirement date. During those five years, they are eligible for pre-retirement and receive an allowance equaling between 75 % and 85 % of their last salary. According to the information provided in the draft performance plan, air traffic controllers are currently placed in DISPO at the age of 56 and this age limit is due to be raised to 57 from 2025 onwards. The Commission notes that no mitigation measures have been presented by Belgium in order to limit the considerable and growing financial impact of the DISPO scheme on the RP3 cost base.

7

| (33) | The Commission further observes that the total costs presented in the revised draft performance plan in respect of the measures outlined in recitals (31) and (32) have been re-evaluated for calendar years 2022 to 2024, leading to an increase of 22,4 % in 2022, of 49,0 % in 2023 and of 36,8 % in 2024. |
| --- | --- |

(33)

The Commission further observes that the total costs presented in the revised draft performance plan in respect of the measures outlined in recitals (31) and (32) have been re-evaluated for calendar years 2022 to 2024, leading to an increase of 22,4 % in 2022, of 49,0 % in 2023 and of 36,8 % in 2024.

| (34) | Furthermore, the revised draft FABEC performance plan refers to additional costs that skeyes will incur in respect of the replacement of its air traffic management (‘ATM’) system with a single, integrated and harmonized airspace management system with MUAC and the Belgian Defense, which aims to support the integration of civil and military ATM services and to enhance capacity and operational efficiencies. The Commission observes that the costs associated with that measure are estimated to be lower than indicated in the draft FABEC performance plan submitted in 2021, by -9,5 % in 2023 and by -11,9 % in 2024. |
| --- | --- |

(34)

Furthermore, the revised draft FABEC performance plan refers to additional costs that skeyes will incur in respect of the replacement of its air traffic management (‘ATM’) system with a single, integrated and harmonized airspace management system with MUAC and the Belgian Defense, which aims to support the integration of civil and military ATM services and to enhance capacity and operational efficiencies. The Commission observes that the costs associated with that measure are estimated to be lower than indicated in the draft FABEC performance plan submitted in 2021, by -9,5 % in 2023 and by -11,9 % in 2024.

| (35) | In respect of MUAC, Belgium and Luxembourg report, similarly as in the draft FABEC performance submitted in 2021, that the collective agreement concluded in 2019 constitutes a measure for the achievement of capacity targets because it aims, in essence, to increase the availability of ATCOs in order to meet traffic demand. The flexibility provisions introduced into the agreement are accompanied by an increase of salary scales by nearly 11 %, which impacts the cost base over the whole reference period. The Commission observes that the costs presented in the revised draft FABEC performance plan in respect of this measure have been revised for calendar years 2022-2024, leading to an increase of 7,4 % in 2022, of 9,0 % in 2023 and of 9,2 % in 2024. |
| --- | --- |

(35)

In respect of MUAC, Belgium and Luxembourg report, similarly as in the draft FABEC performance submitted in 2021, that the collective agreement concluded in 2019 constitutes a measure for the achievement of capacity targets because it aims, in essence, to increase the availability of ATCOs in order to meet traffic demand. The flexibility provisions introduced into the agreement are accompanied by an increase of salary scales by nearly 11 %, which impacts the cost base over the whole reference period. The Commission observes that the costs presented in the revised draft FABEC performance plan in respect of this measure have been revised for calendar years 2022-2024, leading to an increase of 7,4 % in 2022, of 9,0 % in 2023 and of 9,2 % in 2024.

| (36) | Due to the magnitude of the changes in the costs referred to in recitals (33), (34) and (35), the Commission considers that Belgium and Luxembourg should further explain and detail the assumptions underlying the calculation of those costs. |
| --- | --- |

(36)

Due to the magnitude of the changes in the costs referred to in recitals (33), (34) and (35), the Commission considers that Belgium and Luxembourg should further explain and detail the assumptions underlying the calculation of those costs.

| (37) | The revised draft FABEC performance plan reiterates that the achievement of capacity targets by MUAC requires an enhanced post-operations analysis process, related tools and ‘business intelligence facilities’ enabling the further optimization of the planning of daily operations. Belgium and Luxembourg indicate that this set of measures, named the ‘PABI’ project, is foreseen to provide a ‘slight amount of additional capacity’ and to result in some ATFM delay reductions by avoiding unnecessary operational restrictions for airspace users (referred to as ‘over-regulation’). The estimated costs of this project remain unchanged from the draft FABEC performance plan submitted in 2021. The Commission considers that the contribution of the PABI initiative to the achievement of local capacity targets should be further substantiated in order to evaluate whether the related additional costs can be determined as necessary and proportionate for deviating from Union-wide cost-efficiency trends. |
| --- | --- |

(37)

The revised draft FABEC performance plan reiterates that the achievement of capacity targets by MUAC requires an enhanced post-operations analysis process, related tools and ‘business intelligence facilities’ enabling the further optimization of the planning of daily operations. Belgium and Luxembourg indicate that this set of measures, named the ‘PABI’ project, is foreseen to provide a ‘slight amount of additional capacity’ and to result in some ATFM delay reductions by avoiding unnecessary operational restrictions for airspace users (referred to as ‘over-regulation’). The estimated costs of this project remain unchanged from the draft FABEC performance plan submitted in 2021. The Commission considers that the contribution of the PABI initiative to the achievement of local capacity targets should be further substantiated in order to evaluate whether the related additional costs can be determined as necessary and proportionate for deviating from Union-wide cost-efficiency trends.

| (38) | Furthermore, the revised draft performance plan includes three additional measures by MUAC which are regarded by Belgium and Luxembourg to generate additional costs necessary for the achievement of capacity targets. Those measures comprise the ab-initio training of air traffic controllers, the employment of additional air traffic controllers for the Brussels sector of MUAC and a new manpower planning system. |
| --- | --- |

(38)

Furthermore, the revised draft performance plan includes three additional measures by MUAC which are regarded by Belgium and Luxembourg to generate additional costs necessary for the achievement of capacity targets. Those measures comprise the ab-initio training of air traffic controllers, the employment of additional air traffic controllers for the Brussels sector of MUAC and a new manpower planning system.

| (39) | Having regard to the evaluation made by the performance review body, the additional total costs reported by Belgium and Luxembourg in respect of the capacity-enhancement measures referred to in recitals (30) to (38) are significantly lower than the deviation from the long-term Union-wide DUC trend observed in recitals (23) and (26). Therefore, even if one were to accept that all of those measures are necessary and proportionate in view of achieving the local capacity targets, it is clear that the deviation from the long-term DUC trend exceeds in monetary terms the additional costs associated with those measures. That deviation is hence not exclusively due to additional determined costs related to measures necessary to achieve the performance targets in the key performance area of capacity. |
| --- | --- |

(39)

Having regard to the evaluation made by the performance review body, the additional total costs reported by Belgium and Luxembourg in respect of the capacity-enhancement measures referred to in recitals (30) to (38) are significantly lower than the deviation from the long-term Union-wide DUC trend observed in recitals (23) and (26). Therefore, even if one were to accept that all of those measures are necessary and proportionate in view of achieving the local capacity targets, it is clear that the deviation from the long-term DUC trend exceeds in monetary terms the additional costs associated with those measures. That deviation is hence not exclusively due to additional determined costs related to measures necessary to achieve the performance targets in the key performance area of capacity.

| (40) | Therefore, the criterion set out in point 1.4(d)(i) of Annex IV to Implementing Regulation (EU) 2019/317 is not fulfilled in respect of Belgium and Luxembourg. |
| --- | --- |

(40)

Therefore, the criterion set out in point 1.4(d)(i) of Annex IV to Implementing Regulation (EU) 2019/317 is not fulfilled in respect of Belgium and Luxembourg.

| (41) | In respect of the criterion set out in point 1.4(d)(ii) of Annex IV to Implementing Regulation (EU) 2019/317, it suffices to mention that Belgium and Luxembourg have not presented in the revised draft performance plan any restructuring measures which would justify a deviation from the Union-wide DUC trend or from the Union-wide long-term DUC trend. Therefore, the criterion set out in point 1.4(d)(ii) is not fulfilled in respect of Belgium and Luxembourg. |
| --- | --- |

(41)

In respect of the criterion set out in point 1.4(d)(ii) of Annex IV to Implementing Regulation (EU) 2019/317, it suffices to mention that Belgium and Luxembourg have not presented in the revised draft performance plan any restructuring measures which would justify a deviation from the Union-wide DUC trend or from the Union-wide long-term DUC trend. Therefore, the criterion set out in point 1.4(d)(ii) is not fulfilled in respect of Belgium and Luxembourg.

CONCLUSIONS

CONCLUSIONS

| (42) | On the grounds of the findings set out in recitals (11) to (41), the Commission considers, at this stage of the assessment of the revised draft FABEC performance plan, that doubts remain as to the consistency of the cost-efficiency performance targets proposed for the Belgium-Luxembourg en route charging zone. |
| --- | --- |

(42)

On the grounds of the findings set out in recitals (11) to (41), the Commission considers, at this stage of the assessment of the revised draft FABEC performance plan, that doubts remain as to the consistency of the cost-efficiency performance targets proposed for the Belgium-Luxembourg en route charging zone.

en route

| (43) | Accordingly, the Commission notes that the recommendations set out in Article 3 of Implementing Decision (EU) 2022/728 with regard to those performance targets have not been adequately addressed in the revised draft FABEC performance plan. |
| --- | --- |

(43)

Accordingly, the Commission notes that the recommendations set out in Article 3 of Implementing Decision (EU) 2022/728 with regard to those performance targets have not been adequately addressed in the revised draft FABEC performance plan.

| (44) | In particular, the Commission observes that the revised cost-efficiency performance targets proposed for the Belgium-Luxembourg charging zone are consistent neither with the RP3 Union-wide DUC trend, nor with the long-term Union-wide DUC trend. The Commission also observes that the determined costs for the charging zone have not been reduced to a sufficient extent in view of ensuring consistency with the Union-wide performance targets. |
| --- | --- |

(44)

In particular, the Commission observes that the revised cost-efficiency performance targets proposed for the Belgium-Luxembourg charging zone are consistent neither with the RP3 Union-wide DUC trend, nor with the long-term Union-wide DUC trend. The Commission also observes that the determined costs for the charging zone have not been reduced to a sufficient extent in view of ensuring consistency with the Union-wide performance targets.

| (45) | In addition, the Commission did not find, based on the elements and justifications provided in the revised draft FABEC performance plan, that the significant deviation from the long-term Union-wide DUC trend could be exclusively attributed to additional costs incurred for the achievement of the local capacity performance targets. |
| --- | --- |

(45)

In addition, the Commission did not find, based on the elements and justifications provided in the revised draft FABEC performance plan, that the significant deviation from the long-term Union-wide DUC trend could be exclusively attributed to additional costs incurred for the achievement of the local capacity performance targets.

| (46) | Furthermore, the Commission notes that the revised draft FABEC performance plan does not set out major structural measures which would mitigate the planned cost increases over RP3 and contribute to cost-efficiency over the medium and long term. |
| --- | --- |

(46)

Furthermore, the Commission notes that the revised draft FABEC performance plan does not set out major structural measures which would mitigate the planned cost increases over RP3 and contribute to cost-efficiency over the medium and long term.

| (47) | The Commission has therefore decided to initiate the detailed examination set out in Article 15(3) of Implementing Regulation (EU) 2019/317 in respect of the cost-efficiency performance targets for the Belgium-Luxembourg en route charging zone, |
| --- | --- |

(47)

The Commission has therefore decided to initiate the detailed examination set out in Article 15(3) of Implementing Regulation (EU) 2019/317 in respect of the cost-efficiency performance targets for the Belgium-Luxembourg en route charging zone,

en route

HAS ADOPTED THIS DECISION:

Article 1

The following cost-efficiency performance targets proposed for the Belgium-Luxembourg en route charging zone, contained in the revised draft RP3 performance plan established at functional airspace block level by Belgium, Germany, France, Luxembourg, and the Netherlands give rise to doubts in respect of their consistency with the Union-wide performance targets:

KEY PERFORMANCE AREA OF COST-EFFICIENCY

Determined unit cost of en route air navigation services

| En route charging zone of Belgium-Luxembourg | 2014 baseline value | 2019 baseline value | 2020 -2021 | 2022 | 2023 | 2024 |
| --- | --- | --- | --- | --- | --- | --- |
| Revised draft en route cost-efficiency targets, expressed as determined en route unit cost (in real terms in 2017 prices) | 81,78 EUR | 83,26 EUR | 189,52 EUR | 104,47 EUR | 94,18 EUR | 89,87 EUR |

En route charging zone of Belgium-Luxembourg

2014 baseline value

2019 baseline value

2020 -2021

2022

2023

2024

Revised draft en route cost-efficiency targets, expressed as determined en route unit cost (in real terms in 2017 prices)

81,78 EUR

83,26 EUR

189,52 EUR

104,47 EUR

94,18 EUR

89,87 EUR

Article 2

1.   The detailed examination procedure set out in Article 15(3) of Implementing Regulation (EU) 2019/317 is hereby initiated with regard to the cost-efficiency performance targets referred to in Article 1.

2.   In order to support the further assessment of the performance targets referred to in Article 1, Belgium, Germany, France, Luxembourg, and the Netherlands shall provide, upon request by the Commission, relevant additional data and information with regard to the elements set out in the Annex to this Decision.

Article 3

This Decision is addressed to the Kingdom of Belgium, the Federal Republic of Germany, the French Republic, the Grand Duchy of Luxembourg, and the Kingdom of the Netherlands.

Done at Brussels, 24 October 2022.

For the Commission

Adina-Ioana VĂLEAN

Member of the Commission

---

(1)  
  OJ L 96, 31.3.2004, p. 1.

1

(2)  
  OJ L 56, 25.2.2019, p. 1.

2

(3)  Commission Implementing Decision (EU) 2019/903 of 29 May 2019 setting the Union-wide performance targets for the air traffic management network for the third reference period starting on 1 January 2020 and ending on 31 December 2024 (OJ L 144, 3.6.2019, p. 49).

3

(4)  Commission Implementing Regulation (EU) 2020/1627 of 3 November 2020 on exceptional measures for the third reference period (2020-2024) of the single European sky performance and charging scheme due to COVID-19 pandemic (OJ L 366, 4.11.2020, p. 7).

4

(5)  Commission Implementing Decision (EU) 2021/891 of 2 June 2021 setting revised Union-wide performance targets for the air traffic management network for the third reference period (2020-2024) and repealing Implementing Decision (EU) 2019/903 (OJ L 195, 3.6.2021, p. 3).

5

(6)  Commission Implementing Decision (EU) 2022/728 of 13 April 2022 on the inconsistency of certain performance targets contained in the draft national and functional airspace block performance plans submitted by Belgium, Germany, Greece, France, Cyprus, Latvia, Luxembourg, Malta, the Netherlands, Romania, and Sweden pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council with the Union-wide performance targets for the third reference period and setting out recommendations for the revision of those targets (OJ L 135, 12.5.2022, p. 4).

6

(7)  Royal Decree of 23 April 2017.

7

---

ANNEX

NON-EXHAUSTIVE LIST OF ELEMENTS FOR FURTHER ANALYSIS IN RESPECT OF THE COST-EFFICIENCY PERFORMANCE TARGETS FOR THE BELGIUM-LUXEMBOURG EN ROUTE CHARGING ZONE

(1)

Measures invoked by Belgium and Luxembourg in order to justify the observed deviations from Union-wide cost-efficiency trends on the grounds of additional costs for the achievement of capacity targets;

(2)

Complexity of the provision of air navigation services in the charging zone, and its evolution over time;

(3)

Detailed assumptions and parameters underlying the determined costs of skeyes and MUAC, for each year of RP3 and broken down per cost category and service;

(4)

Service units recorded and forecasted in the charging zone, broken down per ANSP;

(5)

Distribution of the MUAC costs and service units between the Brussels sector and the other sectors within the MUAC area of responsibility;

(6)

Capacity planning of skeyes and MUAC including with regard to the planned number of ATCOs, ATCO training, and planned investments in fixed assets;

(7)

Cost allocation between en route and terminal services, and between services in the scope of the performance plan and other services;

(8)

‘DISPO’ pre-retirement scheme for air traffic controllers in Belgium;

(9)

Cross-border service provision arrangements with neighbouring countries, and their operational and financial impact;

(10)

Costs charged to airspace users in RP2 in respect of postponed or delayed investments in fixed assets.

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| 17.11.2022 | EN | Official Journal of the European Union | L 297/80 |
| --- | --- | --- | --- |

17.11.2022

EN

Official Journal of the European Union

L 297/80

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COMMISSION DECISION (EU) 2022/2256

of 15 November 2022

on the initiation of the detailed examination of certain performance targets contained in the revised draft performance plan for the third reference period submitted at functional airspace block level by Switzerland pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council

(notified under document C(2022) 8076)

(Only the German, French and Italian texts are authentic)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Agreement between the European Community and the Swiss Confederation on Air Transport (1),

Having regard to Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (the framework Regulation) (2), and in particular Article 11(3) point (c), second paragraph, thereof,

Having regard to Commission Implementing Regulation (EU) 2019/317 of 11 February 2019 laying down a performance and charging scheme in the single European sky and repealing Implementing Regulations (EU) No 390/2013 and (EU) No 391/2013 (3), and in particular Article 15(1) and (3) thereof,

Whereas:

| (1) | Pursuant to Article 10 of Implementing Regulation (EU) 2019/317, Member States are to draw up, either at national level or at the level of functional airspace blocks (‘FABs’), binding performance targets for each reference period of the performance scheme for air navigation services and network functions. Those performance targets are to be consistent with the Union-wide targets adopted by the Commission for the reference period concerned. |
| --- | --- |

(1)

Pursuant to Article 10 of Implementing Regulation (EU) 2019/317, Member States are to draw up, either at national level or at the level of functional airspace blocks (‘FABs’), binding performance targets for each reference period of the performance scheme for air navigation services and network functions. Those performance targets are to be consistent with the Union-wide targets adopted by the Commission for the reference period concerned.

| (2) | Union-wide performance targets for the third reference period (‘RP3’) were originally set out in Commission Implementing Decision (EU) 2019/903 (4). As those Union-wide performance targets and the draft RP3 performance plans subsequently submitted in October 2019 by the Member States and Switzerland were drawn up before the outbreak of the COVID-19 pandemic in March 2020, they did not take account of the considerable reduction in air traffic due to the measures taken by the Member States and third countries to contain the pandemic. |
| --- | --- |

(2)

Union-wide performance targets for the third reference period (‘RP3’) were originally set out in Commission Implementing Decision (EU) 2019/903 (4). As those Union-wide performance targets and the draft RP3 performance plans subsequently submitted in October 2019 by the Member States and Switzerland were drawn up before the outbreak of the COVID-19 pandemic in March 2020, they did not take account of the considerable reduction in air traffic due to the measures taken by the Member States and third countries to contain the pandemic.

| (3) | In response to the impact of the COVID-19 pandemic on the provision of air navigation services, exceptional measures for RP3, which derogate from the provisions of Implementing Regulation (EU) 2019/317, were set out in Commission Implementing Regulation (EU) 2020/1627 (5). The Commission adopted, on 2 June 2021, Implementing Decision (EU) 2021/891 (6) setting revised Union-wide performance targets for RP3. On that basis, the Member States and Switzerland submitted to the Commission, in October 2021, draft performance plans containing revised performance targets for RP3. |
| --- | --- |

(3)

In response to the impact of the COVID-19 pandemic on the provision of air navigation services, exceptional measures for RP3, which derogate from the provisions of Implementing Regulation (EU) 2019/317, were set out in Commission Implementing Regulation (EU) 2020/1627 (5). The Commission adopted, on 2 June 2021, Implementing Decision (EU) 2021/891 (6) setting revised Union-wide performance targets for RP3. On that basis, the Member States and Switzerland submitted to the Commission, in October 2021, draft performance plans containing revised performance targets for RP3.

| (4) | Commission Implementing Decision (EU) 2022/780 (7) analysed certain performance targets contained in the draft performance plan for RP3 submitted by Switzerland, established jointly at the level of the Functional Airspace Block Europe Central (‘FABEC’), together with Belgium, Germany, France, Luxembourg, and the Netherlands (‘Member States part of FABEC’). The Commission found that the cost-efficiency performance targets for the Belgium-Luxembourg en route charging zone were not consistent with the Union-wide performance targets and issued recommendations for the revision of those targets. |
| --- | --- |

(4)

Commission Implementing Decision (EU) 2022/780 (7) analysed certain performance targets contained in the draft performance plan for RP3 submitted by Switzerland, established jointly at the level of the Functional Airspace Block Europe Central (‘FABEC’), together with Belgium, Germany, France, Luxembourg, and the Netherlands (‘Member States part of FABEC’). The Commission found that the cost-efficiency performance targets for the Belgium-Luxembourg en route charging zone were not consistent with the Union-wide performance targets and issued recommendations for the revision of those targets.

| (5) | In response to Russia’s war of aggression against Ukraine, which started on 24 February 2022, the Union has imposed restrictive measures which prohibit Russian air carriers, any Russian-registered aircraft and any non-Russian-registered aircraft which is owned or chartered, or otherwise controlled by any Russian natural or legal person, entity or body, from landing in and taking off from, or overflying the territory of the Union. Those restrictive measures and the counter-measures adopted by Russia have led to changes in air traffic in European airspace. Certain Member States have been severely affected by the changes in the number of overflights in the airspace under their responsibility. However, at Union-wide level, the observed impact on the number of flights has been limited in contrast with the sharp reduction of air traffic across Europe which resulted from the outbreak of the COVID-19 pandemic. |
| --- | --- |

(5)

In response to Russia’s war of aggression against Ukraine, which started on 24 February 2022, the Union has imposed restrictive measures which prohibit Russian air carriers, any Russian-registered aircraft and any non-Russian-registered aircraft which is owned or chartered, or otherwise controlled by any Russian natural or legal person, entity or body, from landing in and taking off from, or overflying the territory of the Union. Those restrictive measures and the counter-measures adopted by Russia have led to changes in air traffic in European airspace. Certain Member States have been severely affected by the changes in the number of overflights in the airspace under their responsibility. However, at Union-wide level, the observed impact on the number of flights has been limited in contrast with the sharp reduction of air traffic across Europe which resulted from the outbreak of the COVID-19 pandemic.

| (6) | Switzerland, together with the Member States part of FABEC, submitted, on 13 July 2022, a revised draft FABEC performance plan for RP3 (‘revised draft FABEC performance plan’) for assessment by the Commission. |
| --- | --- |

(6)

Switzerland, together with the Member States part of FABEC, submitted, on 13 July 2022, a revised draft FABEC performance plan for RP3 (‘revised draft FABEC performance plan’) for assessment by the Commission.

| (7) | The performance review body, assisting the Commission in the implementation of the performance scheme pursuant to Article 11(2) of Regulation (EC) No 549/2004, has submitted to the Commission a report containing its advice on the assessment of the revised draft FABEC performance plan. |
| --- | --- |

(7)

The performance review body, assisting the Commission in the implementation of the performance scheme pursuant to Article 11(2) of Regulation (EC) No 549/2004, has submitted to the Commission a report containing its advice on the assessment of the revised draft FABEC performance plan.

| (8) | In accordance with Article 15(1) of Implementing Regulation (EU) 2019/317, the Commission has assessed the consistency of the FAB performance targets contained in the revised draft FABEC performance plan on the basis of the assessment criteria laid down in point 1 of Annex IV to that Implementing Regulation, and taking account of local circumstances. In respect of each key performance area and the related performance targets, the Commission has complemented its assessment by reviewing the elements set out in point 2 of Annex IV to that Implementing Regulation. |
| --- | --- |

(8)

In accordance with Article 15(1) of Implementing Regulation (EU) 2019/317, the Commission has assessed the consistency of the FAB performance targets contained in the revised draft FABEC performance plan on the basis of the assessment criteria laid down in point 1 of Annex IV to that Implementing Regulation, and taking account of local circumstances. In respect of each key performance area and the related performance targets, the Commission has complemented its assessment by reviewing the elements set out in point 2 of Annex IV to that Implementing Regulation.

| (9) | The Eurocontrol STATFOR base traffic forecast published in June 2022 takes account of the changed circumstances referred to in recital (5). Based on that forecast, the Commission notes that Switzerland and the Member States part of FABEC are not foreseen to experience major changes in air traffic flows over RP3 as a result of Russia’s war in Ukraine. Therefore, those changed circumstances do not directly impact the performance targets contained in the revised draft FABEC performance plan or the assessment of those targets in respect of their consistency with the Union-wide performance targets. |
| --- | --- |

(9)

The Eurocontrol STATFOR base traffic forecast published in June 2022 takes account of the changed circumstances referred to in recital (5). Based on that forecast, the Commission notes that Switzerland and the Member States part of FABEC are not foreseen to experience major changes in air traffic flows over RP3 as a result of Russia’s war in Ukraine. Therefore, those changed circumstances do not directly impact the performance targets contained in the revised draft FABEC performance plan or the assessment of those targets in respect of their consistency with the Union-wide performance targets.

| (10) | On the basis of the assessment referred to in recital (8), the Commission has found that the performance targets directly applicable to the air navigation service providers operating in the airspace of Switzerland are consistent with the Union-wide performance targets. Therefore, no related findings are set out in this Decision. |
| --- | --- |

(10)

On the basis of the assessment referred to in recital (8), the Commission has found that the performance targets directly applicable to the air navigation service providers operating in the airspace of Switzerland are consistent with the Union-wide performance targets. Therefore, no related findings are set out in this Decision.

| (11) | However, in its Decision (EU) 2022/2255 (8), the Commission has concluded, in respect of the revised draft FABEC performance plan, that the cost-efficiency performance targets proposed for the Belgium-Luxembourg en route charging zone continue to give rise to doubts as to their consistency with the Union-wide performance targets. The Commission has therefore decided to initiate the detailed examination laid down in Article 15(3) of Implementing Regulation (EU) 2019/317 in respect of those performance targets. |
| --- | --- |

(11)

However, in its Decision (EU) 2022/2255 (8), the Commission has concluded, in respect of the revised draft FABEC performance plan, that the cost-efficiency performance targets proposed for the Belgium-Luxembourg en route charging zone continue to give rise to doubts as to their consistency with the Union-wide performance targets. The Commission has therefore decided to initiate the detailed examination laid down in Article 15(3) of Implementing Regulation (EU) 2019/317 in respect of those performance targets.

| (12) | Therefore, Switzerland should be notified that the Commission will initiate the detailed examination set out in Article 15(3) of Implementing Regulation (EU) 2019/317 in respect of the performance targets referred to in recital (11), which are contained in the revised draft FABEC performance plan jointly adopted by the Member States part of FABEC and Switzerland, |
| --- | --- |

(12)

Therefore, Switzerland should be notified that the Commission will initiate the detailed examination set out in Article 15(3) of Implementing Regulation (EU) 2019/317 in respect of the performance targets referred to in recital (11), which are contained in the revised draft FABEC performance plan jointly adopted by the Member States part of FABEC and Switzerland,

HAS ADOPTED THIS DECISION:

Article 1

The detailed examination procedure set out in Article 15(3) of Implementing Regulation (EU) 2019/317 is hereby initiated with regard to the cost-efficiency performance targets referred to in Article 1 of Decision (EU) 2022/2255.

Article 2

This Decision is addressed to the Swiss Confederation.

Done at Brussels, 15 November 2022.

For the Commission

Adina-Ioana VĂLEAN

Member of the Commission

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(1)  
  OJ L 114, 30.4.2002, p. 73.

1

(2)  
  OJ L 96, 31.3.2004, p. 1.

2

(3)  
  OJ L 56, 25.2.2019, p. 1.

3

(4)  Commission Implementing Decision (EU) 2019/903 of 29 May 2019 setting the Union-wide performance targets for the air traffic management network for the third reference period starting on 1 January 2020 and ending on 31 December 2024 (OJ L 144, 3.6.2019, p. 49).

4

(5)  Commission Implementing Regulation (EU) 2020/1627 of 3 November 2020 on exceptional measures for the third reference period (2020-2024) of the single European sky performance and charging scheme due to the COVID-19 pandemic (OJ L 366, 4.11.2020, p. 7).

5

(6)  Commission Implementing Decision (EU) 2021/891 of 2 June 2021 setting revised Union-wide performance targets for the air traffic management network for the third reference period (2020-2024) and repealing Implementing Decision (EU) 2019/903 (OJ L 195, 3.6.2021, p. 3).

6

(7)  Commission Implementing Decision (EU) 2022/780 of 13 April 2022 on the inconsistency of certain performance targets contained in the draft functional airspace block performance plan submitted by Switzerland pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council with the Union-wide performance targets for the third reference period and setting out recommendations for the revision of those targets (OJ L 139, 18.5.2022, p. 218).

7

(8)  Commission Decision (EU) 2022/2255 of 24 October 2022 on the initiation of the detailed examination of certain performance targets contained in the revised draft performance plan for the third reference period submitted at functional airspace block level by Belgium, Germany, France, Luxembourg, and the Netherlands pursuant to Regulation (EC) No 549/2004 of the European Parliament and of the Council (see page 71 of this Official Journal).

8

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Corrigenda

| 17.11.2022 | EN | Official Journal of the European Union | L 297/83 |
| --- | --- | --- | --- |

17.11.2022

EN

Official Journal of the European Union

L 297/83

---

Corrigendum to Commission Implementing Regulation (EU) 2019/1383 of 8 July 2019 amending and correcting Regulation (EU) No 1321/2014 as regards safety management systems in continuing airworthiness management organisations and alleviations for general aviation aircraft concerning maintenance and continuing airworthiness management

(
  Official Journal of the European Union L 228 of 4 September 2019
  )

On page 32, in Annex I, point (59), in the amendment to point (b) of Appendix VIII to Annex I to Regulation (EU) No 1321/2014:

for:

| ‘(59) | in Appendix VIII, point (b)(9) is deleted.’, |
| --- | --- |

‘(59)

in Appendix VIII, point (b)(9) is deleted.’,

read:

| ‘(59) | in Appendix VIII, point (b) is amended as follows:






  (i) | point (b)(9) is deleted; |
| --- | --- | --- |

‘(59)

in Appendix VIII, point (b) is amended as follows:

(i)

point (b)(9) is deleted;

| (ii) | the third sentence is replaced by the following:

  “The criteria 1 to 8 cannot be overridden by less restrictive instructions issued in accordance with ‘M.A.302(d) Maintenance Programme”.’. |
| --- | --- |

(ii)

the third sentence is replaced by the following:

“The criteria 1 to 8 cannot be overridden by less restrictive instructions issued in accordance with ‘M.A.302(d) Maintenance Programme”.’.

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| 17.11.2022 | EN | Official Journal of the European Union | L 297/84 |
| --- | --- | --- | --- |

17.11.2022

EN

Official Journal of the European Union

L 297/84

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Corrigendum to Council Decision (EU) 2022/1975 of 13 October 2022 on the position to be taken on behalf of the European Union within the Trade Committee established by the Free Trade Agreement between the European Union and its Member States, of the one part, and the Republic of Korea, of the other part as regards the amendment of Annexes 10-A and 10-B to the Agreement

(
  Official Journal of the European Union L 271 of 19 October 2022
  )

| 1. | Page 7, recital 10, point (b): |
| --- | --- |

1.

Page 7, recital 10, point (b):

for:

| ‘(b) | Having reviewed the geographical indications of the EU protected in the Agreement and in light of Commission Regulation (EU) 2019/674 of 29 April 2019amending Annex III to Regulation (EC) No 110/2008 of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks(16), the EU requested on November 2020 the removal of the name ‘Polish Cherry’ from Annex 10-B to the Agreement, in accordance with Article 10.25.3(b), as it ceased to be protected in the EU.’, |
| --- | --- |

‘(b)

Having reviewed the geographical indications of the EU protected in the Agreement and in light of Commission Regulation (EU) 2019/674 of 29 April 2019amending Annex III to Regulation (EC) No 110/2008 of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks(16), the EU requested on November 2020 the removal of the name ‘Polish Cherry’ from Annex 10-B to the Agreement, in accordance with Article 10.25.3(b), as it ceased to be protected in the EU.’,

read:

| ‘(b) | Having reviewed the geographical indications of the EU protected in the Agreement and in light of Commission Regulation (EU) 2019/674 of 29 April 2019amending Annex III to Regulation (EC) No 110/2008 of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks(16), the EU requested in November 2020 the removal of the name ‘Polish Cherry’ from Annex 10-B to the Agreement, in accordance with Article 10.25.3(b), as it ceased to be protected in the EU.’. |
| --- | --- |

‘(b)

Having reviewed the geographical indications of the EU protected in the Agreement and in light of Commission Regulation (EU) 2019/674 of 29 April 2019amending Annex III to Regulation (EC) No 110/2008 of the European Parliament and of the Council on the definition, description, presentation, labelling and the protection of geographical indications of spirit drinks(16), the EU requested in November 2020 the removal of the name ‘Polish Cherry’ from Annex 10-B to the Agreement, in accordance with Article 10.25.3(b), as it ceased to be protected in the EU.’.

| 2. | Page 7, footnote 15: |
| --- | --- |

2.

Page 7, footnote 15:

for:

| ‘(15) | 대한민국정부 관보 제20163호 별권1 (official gazette 20163, separate volume 1), 2021.1.6, p. 4.’, |
| --- | --- |

‘(15)

read:

| ‘(15) | 대한민국정부 관보 제20163호 별권1 (official gazette 20163, separate volume 1), 2022.1.6, p. 4.’. |
| --- | --- |

‘(15)

| 3. | Page 9, Article 2, point (6): |
| --- | --- |

3.

Page 9, Article 2, point (6):

for:

| ‘(6) | removal of the geographical indications ‘Seosan Garlic (서산마늘)’, ‘Muan White Lotus Tea (무안백련차)’ and ‘Cheongyang Powdered Hot Pepper (청양고춧가루)’, ‘Yeoju Sweet Potato (여주고구마)’ from the list of geographical indications of Korea in Part B of Annex 10-A to the Agreement; and’, |
| --- | --- |

‘(6)

removal of the geographical indications ‘Seosan Garlic (서산마늘)’, ‘Muan White Lotus Tea (무안백련차)’ and ‘Cheongyang Powdered Hot Pepper (청양고춧가루)’, ‘Yeoju Sweet Potato (여주고구마)’ from the list of geographical indications of Korea in Part B of Annex 10-A to the Agreement; and’,

read:

| ‘(6) | removal of the geographical indications ‘Seosan Garlic (서산마늘)’, ‘Muan White Lotus Tea (무안백련차)’, ‘Cheongyang Powdered Hot Pepper (청양고춧가루)’ and ‘Yeoju Sweet Potato (여주고구마)’ from the list of geographical indications of Korea in Part B of Annex 10-A to the Agreement; and’. |
| --- | --- |

‘(6)

removal of the geographical indications ‘Seosan Garlic (서산마늘)’, ‘Muan White Lotus Tea (무안백련차)’, ‘Cheongyang Powdered Hot Pepper (청양고춧가루)’ and ‘Yeoju Sweet Potato (여주고구마)’ from the list of geographical indications of Korea in Part B of Annex 10-A to the Agreement; and’.

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