# Official Journal L 74/2023

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 74 |
| | |
| English edition | Legislation | Volume 6613 March 2023 |

ISSN 1977-0677

Official Journal

of the European Union

L 74

English edition

Legislation

Volume 6613 March 2023

---

| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Implementing Regulation (EU) 2023/562 of 6 March 2023 entering a name in the register of protected designations of origin and protected geographical indications (Antakya Künefesi (PGI)) | 1 |
| | * | Commission Implementing Regulation (EU) 2023/563 of 6 March 2023 entering a name in the register of protected designations of origin and protected geographical indications (Íslenskt lambakjöt (PDO)) | 3 |
| | * | Commission Implementing Regulation (EU) 2023/564 of 10 March 2023 as regards the content and format of the records of plant protection products kept by professional users pursuant to Regulation (EC) No 1107/2009 of the European Parliament and of the Council (
  1
  ) | 4 |
| | * | Commission Implementing Regulation (EU) 2023/565 of 10 March 2023 concerning the authorisation of ethyl heptanoate, ethyl 2-methylbutyrate, isopentyl acetate, 3-methylbutyl 3-methylbutyrate, 2-methylpropionic acid, 3-methylbutyl butyrate, 2-methylbutyl acetate, hex-2-en-1-ol, hex-2(trans)-enal, allyl hexanoate, allyl heptanoate, linalool, 2-methyl-1-phenylpropan-2-ol, alpha-ionone, beta-damascone, nootkatone, beta-ionone, alpha-irone, beta-damascenone, (E)-beta-damascone, pentadecano-1,15-lactone, 2-phenylethan-1-ol, phenethyl isovalerate, 4-(p-hydroxyphenyl)butan-2-one, 2-methoxynaphthalene, 2-isopropyl-4-methylthiazole and valencene as feed additives for all animal species (
  1
  ) | 10 |
| | * | Commission Implementing Regulation (EU) 2023/566 of 10 March 2023 amending Implementing Regulation (EU) 2015/1998 as regards certain detailed measures for the implementation of the common basic standards on aviation security (
  1
  ) | 47 |
| | | DECISIONS |
| | * | Council Decision (EU) 2023/567 of 9 March 2023 on the position to be taken, on behalf of the European Union, in the 66th session of the Commission on Narcotic Drugs on the scheduling of substances under the Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol, and the Convention on Psychotropic Substances of 1971 | 53 |
| | * | Council Decision (EU) 2023/568 of 9 March 2023 on the position to be taken on behalf of the Union in the 228th session of the Council of the International Civil Aviation Organization (ICAO) as regards the adoption of Amendment 93 to Annex 10 – Aeronautical Telecommunications, Volume I – Radio Navigation Aids of the Convention on International Civil Aviation and of the amendment to the Technical instructions for the safe transport of dangerous goods by air to permit active tracking devices powered by small lithium batteries in checked baggage | 58 |
| | * | Council Decision (EU) 2023/569 of 9 March 2023 on the position to be taken on behalf of the European Union at the Council of the International Civil Aviation Organization, in respect of proposals for the amendment of Annex 16, Volumes I to III to the Chicago Convention, concerning Standards and Recommended Practices relating to environmental protection | 61 |
| | * | Commission Implementing Decision (EU) 2023/570 of 10 March 2023 granting derogations to certain Member States from the application of Regulation (EC) No 138/2004 of the European Parliament and of the Council on the economic accounts for agriculture
  (notified under document C(2023) 1562) | 63 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Implementing Regulation (EU) 2023/562 of 6 March 2023 entering a name in the register of protected designations of origin and protected geographical indications (Antakya Künefesi (PGI))

1

*

Commission Implementing Regulation (EU) 2023/563 of 6 March 2023 entering a name in the register of protected designations of origin and protected geographical indications (Íslenskt lambakjöt (PDO))

3

*

Commission Implementing Regulation (EU) 2023/564 of 10 March 2023 as regards the content and format of the records of plant protection products kept by professional users pursuant to Regulation (EC) No 1107/2009 of the European Parliament and of the Council (
  1
  )

1

4

*

Commission Implementing Regulation (EU) 2023/565 of 10 March 2023 concerning the authorisation of ethyl heptanoate, ethyl 2-methylbutyrate, isopentyl acetate, 3-methylbutyl 3-methylbutyrate, 2-methylpropionic acid, 3-methylbutyl butyrate, 2-methylbutyl acetate, hex-2-en-1-ol, hex-2(trans)-enal, allyl hexanoate, allyl heptanoate, linalool, 2-methyl-1-phenylpropan-2-ol, alpha-ionone, beta-damascone, nootkatone, beta-ionone, alpha-irone, beta-damascenone, (E)-beta-damascone, pentadecano-1,15-lactone, 2-phenylethan-1-ol, phenethyl isovalerate, 4-(p-hydroxyphenyl)butan-2-one, 2-methoxynaphthalene, 2-isopropyl-4-methylthiazole and valencene as feed additives for all animal species (
  1
  )

1

10

*

Commission Implementing Regulation (EU) 2023/566 of 10 March 2023 amending Implementing Regulation (EU) 2015/1998 as regards certain detailed measures for the implementation of the common basic standards on aviation security (
  1
  )

1

47

DECISIONS

*

Council Decision (EU) 2023/567 of 9 March 2023 on the position to be taken, on behalf of the European Union, in the 66th session of the Commission on Narcotic Drugs on the scheduling of substances under the Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol, and the Convention on Psychotropic Substances of 1971

53

*

Council Decision (EU) 2023/568 of 9 March 2023 on the position to be taken on behalf of the Union in the 228th session of the Council of the International Civil Aviation Organization (ICAO) as regards the adoption of Amendment 93 to Annex 10 – Aeronautical Telecommunications, Volume I – Radio Navigation Aids of the Convention on International Civil Aviation and of the amendment to the Technical instructions for the safe transport of dangerous goods by air to permit active tracking devices powered by small lithium batteries in checked baggage

58

*

Council Decision (EU) 2023/569 of 9 March 2023 on the position to be taken on behalf of the European Union at the Council of the International Civil Aviation Organization, in respect of proposals for the amendment of Annex 16, Volumes I to III to the Chicago Convention, concerning Standards and Recommended Practices relating to environmental protection

61

*

Commission Implementing Decision (EU) 2023/570 of 10 March 2023 granting derogations to certain Member States from the application of Regulation (EC) No 138/2004 of the European Parliament and of the Council on the economic accounts for agriculture
  (notified under document C(2023) 1562)

(notified under document C(2023) 1562)

63

| | |
| --- | --- |
| | (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.

---

II Non-legislative acts

REGULATIONS

| 13.3.2023 | EN | Official Journal of the European Union | L 74/1 |
| --- | --- | --- | --- |

13.3.2023

EN

Official Journal of the European Union

L 74/1

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/562

of 6 March 2023

entering a name in the register of protected designations of origin and protected geographical indications (‘Antakya Künefesi’ (PGI))

THE EUROPEAN COMMISSION,

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

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

Whereas:

| (1) | Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Turkey’s application to register the name ‘Antakya Künefesi’ was published in the Official Journal of the European Union (2). |
| --- | --- |

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Turkey’s application to register the name ‘Antakya Künefesi’ was published in the Official Journal of the European Union (2).

| (2) | As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Antakya Künefesi’ should therefore be entered in the register, |
| --- | --- |

(2)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Antakya Künefesi’ should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Antakya Künefesi’ (PGI) is hereby entered in the register.

The name specified in the first paragraph denotes a product in Class 2.3 – bread, pastry, cakes, confectionery, biscuits and other baker’s wares, as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

Article 2

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

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

Done at Brussels, 6 March 2023.

For the Commission,

On behalf of the President,

Janusz WOJCIECHOWSKI

Member of the Commission

---

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

1

(2)  OJ C 433, 15.11.2022, p. 64.

2

(3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).

3

---

| 13.3.2023 | EN | Official Journal of the European Union | L 74/3 |
| --- | --- | --- | --- |

13.3.2023

EN

Official Journal of the European Union

L 74/3

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/563

of 6 March 2023

entering a name in the register of protected designations of origin and protected geographical indications (‘Íslenskt lambakjöt’ (PDO))

THE EUROPEAN COMMISSION,

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

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

Whereas:

| (1) | Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Iceland’s application to register the name ‘Íslenskt lambakjöt’ was published in the Official Journal of the European Union (2). |
| --- | --- |

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, Iceland’s application to register the name ‘Íslenskt lambakjöt’ was published in the Official Journal of the European Union (2).

| (2) | As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Íslenskt lambakjöt’ should therefore be entered in the register, |
| --- | --- |

(2)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Íslenskt lambakjöt’ should therefore be entered in the register,

HAS ADOPTED THIS REGULATION:

Article 1

The name ‘Íslenskt lambakjöt’ (PDO) is hereby entered in the register.

The name specified in the first paragraph denotes a product in Class 1.1. Fresh meat (and offal), as listed in Annex XI to Commission Implementing Regulation (EU) No 668/2014 (3).

Article 2

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

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

Done at Brussels, 6 March 2023.

For the Commission,

On behalf of the President,

Janusz WOJCIECHOWSKI

Member of the Commission

---

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

1

(2)  OJ C 370, 28.9.2022, p. 45.

2

(3)  Commission Implementing Regulation (EU) No 668/2014 of 13 June 2014 laying down rules for the application of Regulation (EU) No 1151/2012 of the European Parliament and of the Council on quality schemes for agricultural products and foodstuffs (OJ L 179, 19.6.2014, p. 36).

3

---

| 13.3.2023 | EN | Official Journal of the European Union | L 74/4 |
| --- | --- | --- | --- |

13.3.2023

EN

Official Journal of the European Union

L 74/4

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/564

of 10 March 2023

as regards the content and format of the records of plant protection products kept by professional users pursuant to Regulation (EC) No 1107/2009 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 (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular Article 67(4) thereof,

Whereas:

| (1) | Pursuant to Article 67(1) of Regulation (EC) No 1107/2009, professional users of plant protection products are to keep records of those products they use, containing the name of the product, the time and the dose of application, the area treated and the crop where the product was used. |
| --- | --- |

(1)

Pursuant to Article 67(1) of Regulation (EC) No 1107/2009, professional users of plant protection products are to keep records of those products they use, containing the name of the product, the time and the dose of application, the area treated and the crop where the product was used.

| (2) | Under Article 67(1) of Regulation (EC) No 1107/2009, professional users are also to make the relevant information available to the competent authority on request. Furthermore, third parties may request the competent authorities to provide access to that information and competent authorities are to provide such access in accordance with applicable national or Union law. |
| --- | --- |

(2)

Under Article 67(1) of Regulation (EC) No 1107/2009, professional users are also to make the relevant information available to the competent authority on request. Furthermore, third parties may request the competent authorities to provide access to that information and competent authorities are to provide such access in accordance with applicable national or Union law.

| (3) | The Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system (‘the Farm to Fork Strategy’) (2), adopted by the Commission in 2020, aims to reduce dependency on, and use of, chemical plant protection products. Adequate recording of the use of plant protection products, and national authorities’ monitoring and control activities based on such records, are therefore instrumental to the achievement of the Farm to Fork Strategy’s objectives. |
| --- | --- |

(3)

The Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system (‘the Farm to Fork Strategy’) (2), adopted by the Commission in 2020, aims to reduce dependency on, and use of, chemical plant protection products. Adequate recording of the use of plant protection products, and national authorities’ monitoring and control activities based on such records, are therefore instrumental to the achievement of the Farm to Fork Strategy’s objectives.

| (4) | There are differences between national regimes as regards the records kept by professional users of plant protection products under Article 67(1) of Regulation (EC) No 1107/2009 and whether they are kept electronically. Therefore, this Regulation establishes detailed rules on the content and format of those records. |
| --- | --- |

(4)

There are differences between national regimes as regards the records kept by professional users of plant protection products under Article 67(1) of Regulation (EC) No 1107/2009 and whether they are kept electronically. Therefore, this Regulation establishes detailed rules on the content and format of those records.

| (5) | Those rules define how the elements listed in Article 67(1) of Regulation (EC) No 1107/2009 relating to the use of plant protection products (name of the product, time, dose, area and crop of application) are to be recorded, so that the adequate and uniform quality of records kept under that article is ensured throughout the Union. |
| --- | --- |

(5)

Those rules define how the elements listed in Article 67(1) of Regulation (EC) No 1107/2009 relating to the use of plant protection products (name of the product, time, dose, area and crop of application) are to be recorded, so that the adequate and uniform quality of records kept under that article is ensured throughout the Union.

| (6) | As the use of plant protection products by professional users most often occurs as part of agricultural activities and in order to align with existing requirements relevant for agriculture, when possible, identification of the location of the area or facility where the plant protection product was used should be done through the unit of land within the scope of the geo-spatial aid application of the integrated administration and control system as referred to in Commission Implementing Regulation (EU) 2022/1173 (3). When this is not possible, Member States should provide professional users with appropriate alternative methods for the identification of the location of the area where the plant protection product was used, and, where relevant, the geospatial location. |
| --- | --- |

(6)

As the use of plant protection products by professional users most often occurs as part of agricultural activities and in order to align with existing requirements relevant for agriculture, when possible, identification of the location of the area or facility where the plant protection product was used should be done through the unit of land within the scope of the geo-spatial aid application of the integrated administration and control system as referred to in Commission Implementing Regulation (EU) 2022/1173 (3). When this is not possible, Member States should provide professional users with appropriate alternative methods for the identification of the location of the area where the plant protection product was used, and, where relevant, the geospatial location.

| (7) | To achieve uniformity of the records, the crop names, situations or land uses should be recorded, where applicable, in line with the codes used by the European and Mediterranean Plant Protection Organization (‘EPPO codes’) and the growth stages of plants, where applicable, in accordance with the BBCH monograph (4). |
| --- | --- |

(7)

To achieve uniformity of the records, the crop names, situations or land uses should be recorded, where applicable, in line with the codes used by the European and Mediterranean Plant Protection Organization (‘EPPO codes’) and the growth stages of plants, where applicable, in accordance with the BBCH monograph (4).

| (8) | In order to avoid requiring professional users to create multiple sets of records for the same use to comply with different obligations, it is appropriate to clarify that Member States have the possibility to require the users to include other information in combination with the records required under Article 67(1) of Regulation (EC) No 1107/2009. |
| --- | --- |

(8)

In order to avoid requiring professional users to create multiple sets of records for the same use to comply with different obligations, it is appropriate to clarify that Member States have the possibility to require the users to include other information in combination with the records required under Article 67(1) of Regulation (EC) No 1107/2009.

| (9) | Records should be kept electronically, as electronic means of record-keeping are best suited to enable a uniform application of the record-keeping obligation. This ensures greater reliability of the records, facilitates their collection and verification by the competent authorities and ultimately supports accurate, efficient and effective monitoring and control activities by Member States. To this end, the electronic formats used should also be machine-readable as defined in Directive (EU) 2019/1024 of the European Parliament and of the Council (5). |
| --- | --- |

(9)

Records should be kept electronically, as electronic means of record-keeping are best suited to enable a uniform application of the record-keeping obligation. This ensures greater reliability of the records, facilitates their collection and verification by the competent authorities and ultimately supports accurate, efficient and effective monitoring and control activities by Member States. To this end, the electronic formats used should also be machine-readable as defined in Directive (EU) 2019/1024 of the European Parliament and of the Council (5).

| (10) | To reduce the administrative burden, professional users should have sufficient time between recording of each use of plant protection products and the transfer of the records into electronic format. |
| --- | --- |

(10)

To reduce the administrative burden, professional users should have sufficient time between recording of each use of plant protection products and the transfer of the records into electronic format.

| (11) | A professional user may use plant protection products under contractual arrangements for another natural or legal person. In those cases, the professional user should provide access to or a copy of the relevant records kept to that person without any undue delays or restrictions. |
| --- | --- |

(11)

A professional user may use plant protection products under contractual arrangements for another natural or legal person. In those cases, the professional user should provide access to or a copy of the relevant records kept to that person without any undue delays or restrictions.

| (12) | This Regulation is without prejudice to the use of the data contained in the records for other purposes outside of the scope of Regulation (EC) No 1107/2009 in accordance with Union or national law. The availability of harmonised electronic records can facilitate the use of the information for other legitimate purposes, thereby avoiding duplication of efforts and reducing the burden on professional users and public authorities. |
| --- | --- |

(12)

This Regulation is without prejudice to the use of the data contained in the records for other purposes outside of the scope of Regulation (EC) No 1107/2009 in accordance with Union or national law. The availability of harmonised electronic records can facilitate the use of the information for other legitimate purposes, thereby avoiding duplication of efforts and reducing the burden on professional users and public authorities.

| (13) | In order to allow professional users to prepare themselves to meet the requirements set out in this Regulation, they should be given reasonable time before its requirements become applicable. |
| --- | --- |

(13)

In order to allow professional users to prepare themselves to meet the requirements set out in this Regulation, they should be given reasonable time before its requirements become applicable.

| (14) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(14)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Content of the records

1.   Professional users of plant protection products shall provide in the records referred to in Article 67(1) of Regulation (EC) No 1107/2009 (‘the records’) the information as set out in the Annex to this Regulation.

2.   Where the location of an area or facility where a plant protection product was used cannot be identified through the unit of land within the scope of the geospatial aid application of the integrated administration and control system as referred to in Article 8(3), point (b), of Implementing Regulation (EU) 2022/1173, or where pursuant to paragraph 1, this is not required for a type of use, Member States shall provide professional users with appropriate alternative identification methods. Such identification methods shall enable the identification of the location of the area, unit, or facility where the plant protection product was used, and, where relevant, its geospatial location.

3.   Member States shall make available to professional users common names of crops, situations or land uses corresponding to EPPO codes and of growth stages of crops, in accordance with the BBCH monograph for recording the use of plant protection products.

4.   The provisions in this Article are without prejudice to the possibility of Member States to require that professional users include other information outside the scope of Article 67(1) of Regulation (EC) No 1107/2009 in the records.

Article 2

Format of the records

Professional users of plant protection products shall keep the records electronically using a machine-readable format as defined in Article 2(13) of Directive (EU) 2019/1024.

Article 3

Timing of recording and of transfer to electronic format

The professional user shall record each use of a plant protection product without undue delay.

Where the records are not initially created in the prescribed electronic format, they shall be transferred into such a format no later than 30 days from the date of use of the plant protection product. For uses of plant protection products on their territory, Member States may provide for shorter periods for the transfer into the prescribed electronic format.

For uses of plant protection products on their territory before 1 January 2030, Member States may allow for longer periods than those set out in the second paragraph, within which the records shall be transferred into the prescribed electronic format, as long as all records are available in the prescribed electronic format before 31 January of the year following the year of use of the plant protection product.

Article 4

Provision of information to the competent authorities and other natural or legal persons

When requested by the competent authority pursuant to Article 67(1) of Regulation (EC) No 1107/2009 to provide information contained in the records, the professional user shall provide the information without undue delay.

When the competent authority explicitly requests information contained in the records created for uses of plant protection products in the prescribed electronic format as set out in Article 2 before the relevant period set out in Article 3, second and third paragraph, has expired, the professional user shall provide the information in the prescribed electronic format before the expiration of that period or within 10 working days, whichever comes first.

Professional users that act under contractual arrangements for another natural or legal person, shall provide access to or a copy of the records to that contracting person without undue delay or restrictions.

Article 5

Entry into force and application

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

It shall apply from 1 January 2026.

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

Done at Brussels, 10 March 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 309, 24.11.2009, p. 1.

1

(2)  Communication from the Commission to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system (COM(2020) 381 final).

2

(3)  Commission Implementing Regulation (EU) 2022/1173 of 31 May 2022 laying down rules for the application of Regulation (EU) 2021/2116 of the European Parliament and of the Council with regard to the integrated administration and control system in the common agricultural policy (OJ L 183, 8.7.2022, p. 23).

3

(4)  Meier, Uwe, ed. Growth stages of mono- and dicotyledonous plants. BBCH Monograph. Quedlinburg 2018. Open Agrar Repositorium. doi: 10.5073/20180906-074619 ISBN: 978-3-95547-071-5.

4

(5)  Directive (EU) 2019/1024 of the European Parliament and of the Council of 20 June 2019 on open data and the re-use of public sector information (OJ L 172, 26.6.2019, p. 56).

5

---

ANNEX

Information to be included in the records as provided for in Article 1

| Type of use | Plant protection product used | Time of use | Dose of application (1) | Location or identification of treated area or unit (2) | Size or amount of treated area or unit (3) | Crop or situation/land use |
| --- | --- | --- | --- | --- | --- | --- |
| Treatment of surface areas (such as agricultural fields, amenity areas, railway tracks, non-crop areas or greenhouses other than those referred to in the next row) | Product name and authorisation number | Date and where relevant (4) start time (hour) | Amount in kilograms/litres of plant protection product applied per hectare | Where available, the unit of land within the scope of the geo-spatial aid application of the integrated administration and control system as referred in Article 8(3), point (b), of Implementing Regulation (EU) 2022/1173.
  Where the area cannot be identified within the scope of the geo-spatial aid application as referred above, identification method referred to in Article 1(2). | Number of hectares treated | Crop names, situations/land uses in line with the EPPO codes (5), where applicable and growth stage in line with BBCH monograph (6), where relevant (7) |
| Treatment of or in closed spaces (such as fogging/spraying storage facilities, empty grain storage rooms or permanent greenhouses as defined in Article 3(27) of Regulation (EC) No 1107/2009) | Product name and authorisation number | Date | Amount in kilograms/litres of plant protection product applied per cubic metre or per square meter | Store/greenhouse number and identification method referred to in Article 1(2). | Volume in cubic metres or surface area (8) in square meters of the facility treated | Crop names, situations in line with the EPPO codes, where applicable and growth stage in line with BBCH monograph, where relevant |
| Treatment of seeds or plant reproductive material (such as seed potatoes) | Product name and authorisation number | Date | Amount in kilograms/litres of plant protection product applied per kilogram, tonne or number of seeds (9) | Identification method referred to in Article 1(2). | Amount treated in kilograms, tonnes or number of seeds | Crop names in line with the EPPO codes, where applicable and batch number, where applicable |

Type of use

Plant protection product used

Time of use

Dose of application (1)

Location or identification of treated area or unit (2)

Size or amount of treated area or unit (3)

Crop or situation/land use

Treatment of surface areas (such as agricultural fields, amenity areas, railway tracks, non-crop areas or greenhouses other than those referred to in the next row)

Product name and authorisation number

Date and where relevant (4) start time (hour)

Amount in kilograms/litres of plant protection product applied per hectare

Where available, the unit of land within the scope of the geo-spatial aid application of the integrated administration and control system as referred in Article 8(3), point (b), of Implementing Regulation (EU) 2022/1173.

Where the area cannot be identified within the scope of the geo-spatial aid application as referred above, identification method referred to in Article 1(2).

Number of hectares treated

Crop names, situations/land uses in line with the EPPO codes (5), where applicable and growth stage in line with BBCH monograph (6), where relevant (7)

Treatment of or in closed spaces (such as fogging/spraying storage facilities, empty grain storage rooms or permanent greenhouses as defined in Article 3(27) of Regulation (EC) No 1107/2009)

Product name and authorisation number

Date

Amount in kilograms/litres of plant protection product applied per cubic metre or per square meter

Store/greenhouse number and identification method referred to in Article 1(2).

Volume in cubic metres or surface area (8) in square meters of the facility treated

Crop names, situations in line with the EPPO codes, where applicable and growth stage in line with BBCH monograph, where relevant

Treatment of seeds or plant reproductive material (such as seed potatoes)

Product name and authorisation number

Date

Amount in kilograms/litres of plant protection product applied per kilogram, tonne or number of seeds (9)

Identification method referred to in Article 1(2).

Amount treated in kilograms, tonnes or number of seeds

Crop names in line with the EPPO codes, where applicable and batch number, where applicable

---

(1)  Units for recording the amounts can be adjusted, where appropriate.

(2)  Indicated what fraction of the unit or area is treated, if appropriate.

(3)  Units for recording the area and volume can be adjusted, where appropriate.

(4)  e.g. when the use of plant protection product is restricted to specific times of the day or when the time of use is relevant in the context of the particular use.

(5)  https://gd.eppo.int/

(6)  Meier, Uwe, ed. Growth stages of mono- and dicotyledonous plants. BBCH Monograph. Quedlinburg 2018. Open Agrar Repositorium. doi: 10.5073/20180906-074619 ISBN: 978-3-95547-071-5.

(7)  e.g. when the use of plant protection product is restricted to particular growth stages or when the growth stage is relevant in the context of the particular use.

(8)  For multi-layered facilities, the total area treated should be recorded.

(9)  Units for recording the amounts treated can be adjusted, where appropriate.

---

| 13.3.2023 | EN | Official Journal of the European Union | L 74/10 |
| --- | --- | --- | --- |

13.3.2023

EN

Official Journal of the European Union

L 74/10

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/565

of 10 March 2023

concerning the authorisation of ethyl heptanoate, ethyl 2-methylbutyrate, isopentyl acetate, 3-methylbutyl 3-methylbutyrate, 2-methylpropionic acid, 3-methylbutyl butyrate, 2-methylbutyl acetate, hex-2-en-1-ol, hex-2(trans)-enal, allyl hexanoate, allyl heptanoate, linalool, 2-methyl-1-phenylpropan-2-ol, alpha-ionone, beta-damascone, nootkatone, beta-ionone, alpha-irone, beta-damascenone, (E)-beta-damascone, pentadecano-1,15-lactone, 2-phenylethan-1-ol, phenethyl isovalerate, 4-(p-hydroxyphenyl)butan-2-one, 2-methoxynaphthalene, 2-isopropyl-4-methylthiazole and valencene as feed additives for all animal species

(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 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:

| (1) | Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2). |
| --- | --- |

(1)

Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation. Article 10(2) of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC (2).

| (2) | The substances ethyl heptanoate, ethyl 2-methylbutyrate, isopentyl acetate, 3-methylbutyl 3-methylbutyrate, 2-methylpropionic acid, 3-methylbutyl butyrate, 2-methylbutyl acetate, hex-2-en-1-ol, hex-2(trans)-enal, allyl hexanoate, allyl heptanoate, linalool, 2-methyl-1-phenylpropan-2-ol, alpha-ionone, beta-damascone, nootkatone, beta-ionone, alpha-irone, beta-damascenone, (E)-beta-damascone, pentadecano-1,15-lactone, 2-phenylethan-1-ol, phenethyl isovalerate, 4-(p-hydroxyphenyl)butan-2-one, 2-methoxynaphthalene, 2-isopropyl-4-methylthiazole and valencene were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of Feed Additives as existing products belonging to the functional group of flavouring compounds, in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003. |
| --- | --- |

(2)

The substances ethyl heptanoate, ethyl 2-methylbutyrate, isopentyl acetate, 3-methylbutyl 3-methylbutyrate, 2-methylpropionic acid, 3-methylbutyl butyrate, 2-methylbutyl acetate, hex-2-en-1-ol, hex-2(trans)-enal, allyl hexanoate, allyl heptanoate, linalool, 2-methyl-1-phenylpropan-2-ol, alpha-ionone, beta-damascone, nootkatone, beta-ionone, alpha-irone, beta-damascenone, (E)-beta-damascone, pentadecano-1,15-lactone, 2-phenylethan-1-ol, phenethyl isovalerate, 4-(p-hydroxyphenyl)butan-2-one, 2-methoxynaphthalene, 2-isopropyl-4-methylthiazole and valencene were authorised without a time limit in accordance with Directive 70/524/EEC as feed additives for all animal species. Those substances were subsequently entered in the Register of Feed Additives as existing products belonging to the functional group of flavouring compounds, in accordance with Article 10(1), point (b), of Regulation (EC) No 1831/2003.

| (3) | In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, several applications were submitted for the authorisation of the above-mentioned substances as feed additives for all animal species. The applicant requested the additives to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. The applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. |
| --- | --- |

(3)

In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 thereof, several applications were submitted for the authorisation of the above-mentioned substances as feed additives for all animal species. The applicant requested the additives to be classified in the additive category ‘sensory additives’ and in the functional group ‘flavouring compounds’. The applications were accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.

| (4) | The applicant requested the additives to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water for drinking. Therefore, the applicant withdrew the application for water for drinking for all the substances concerned. |
| --- | --- |

(4)

The applicant requested the additives to be authorised for use also in water for drinking. However, Regulation (EC) No 1831/2003 does not allow the authorisation of ‘flavouring compounds’ for use in water for drinking. Therefore, the applicant withdrew the application for water for drinking for all the substances concerned.

| (5) | The European Food Safety Authority (‘the Authority’) concluded in its opinions of 7 March 2012 (3), 25 April 2012 (4), 17 October 2012 (5) (6), 13 November 2012 (7), 12 March 2013 (8), 10 March 2015 (9), 8 March 2016 (10), 20 April 2016 (11), 12 July 2016 (12), 28 February 2019 (13), 18 November 2020 (14) and 23 March 2022 (15) that, under the proposed conditions of use, the substances do not have adverse effects on animal health, consumer safety or the environment. The Authority concluded that for 2-methyl-1-phenylpropan-2-ol, beta-damascone, alpha-irone, (E)-beta-damascone, phenethyl isovalerate, 4-(p-hydroxyphenyl) butan-2-one, and 2-isopropyl-4-methylthiazole, the safe use level for the marine environment is estimated to be 0,05 mg/kg feed. |
| --- | --- |

(5)

The European Food Safety Authority (‘the Authority’) concluded in its opinions of 7 March 2012 (3), 25 April 2012 (4), 17 October 2012 (5) (6), 13 November 2012 (7), 12 March 2013 (8), 10 March 2015 (9), 8 March 2016 (10), 20 April 2016 (11), 12 July 2016 (12), 28 February 2019 (13), 18 November 2020 (14) and 23 March 2022 (15) that, under the proposed conditions of use, the substances do not have adverse effects on animal health, consumer safety or the environment. The Authority concluded that for 2-methyl-1-phenylpropan-2-ol, beta-damascone, alpha-irone, (E)-beta-damascone, phenethyl isovalerate, 4-(p-hydroxyphenyl) butan-2-one, and 2-isopropyl-4-methylthiazole, the safe use level for the marine environment is estimated to be 0,05 mg/kg feed.

| (6) | The Authority also concluded that all the substances should be considered as irritants to skin and eyes and as potential skin and respiratory sensitisers in susceptible individuals. In the absence of data for hex-2-en-1-ol, hex-2(trans)-enal, allyl hexanoate and allyl heptanoate, the Authority could not conclude that users can safely handle those substances. However, the applicant, as required, produced a safety data sheet where hazards for users have been identified for those substances. The hazards described in the safety data sheet were, in particular, hazards for skin, eye contact and respiratory exposure for hex-2(trans)-enal, hazards for skin and eye contact for hex-2-en-1-ol and allyl heptanoate and harmful if swallowed and toxic in contact with skin for allyl hexanoate. |
| --- | --- |

(6)

The Authority also concluded that all the substances should be considered as irritants to skin and eyes and as potential skin and respiratory sensitisers in susceptible individuals. In the absence of data for hex-2-en-1-ol, hex-2(trans)-enal, allyl hexanoate and allyl heptanoate, the Authority could not conclude that users can safely handle those substances. However, the applicant, as required, produced a safety data sheet where hazards for users have been identified for those substances. The hazards described in the safety data sheet were, in particular, hazards for skin, eye contact and respiratory exposure for hex-2(trans)-enal, hazards for skin and eye contact for hex-2-en-1-ol and allyl heptanoate and harmful if swallowed and toxic in contact with skin for allyl hexanoate.

| (7) | The Authority finally concluded that all substances are recognised to flavour food and their function in feed would be essentially the same as that in food. Therefore, no further demonstration of efficacy is considered necessary. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. |
| --- | --- |

(7)

The Authority finally concluded that all substances are recognised to flavour food and their function in feed would be essentially the same as that in food. Therefore, no further demonstration of efficacy is considered necessary. It also verified the report on the methods of analysis of the feed additives in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

| (8) | The assessment of all the substances shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised. The Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. |
| --- | --- |

(8)

The assessment of all the substances shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied. Accordingly, the use of those substances should be authorised. The Commission considers that appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive.

| (9) | Certain conditions should be provided for to allow better control. In particular, a recommended maximum content should be indicated on the label of the feed additives. Where such content is exceeded, certain information should be indicated on the label of premixtures. |
| --- | --- |

(9)

Certain conditions should be provided for to allow better control. In particular, a recommended maximum content should be indicated on the label of the feed additives. Where such content is exceeded, certain information should be indicated on the label of premixtures.

| (10) | The fact that the substances are not authorised for use as flavourings in water for drinking does not preclude their use in compound feed which is administered via water. |
| --- | --- |

(10)

The fact that the substances are not authorised for use as flavourings in water for drinking does not preclude their use in compound feed which is administered via water.

| (11) | Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substances concerned, it is appropriate to provide for a transitional period for the interested parties to prepare themselves to meet the new requirements resulting from the authorisation. |
| --- | --- |

(11)

Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the substances concerned, it is appropriate to provide for a transitional period for the interested parties to prepare themselves to meet the new requirements resulting from the authorisation.

| (12) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(12)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS REGULATION:

Article 1

Authorisation

The substances specified in the Annex, belonging to the additive category ‘sensory additives’ and to the functional group ‘flavouring compounds’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

Transitional measures

1.   The substances specified in the Annex and premixtures containing these substances, which are produced and labelled before 2 October 2023 in accordance with the rules applicable before 2 April 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substances specified in the Annex, which are produced and labelled before 2 April 2024 in accordance with the rules applicable before 2 April 2023 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the substances specified in the Annex, which are produced and labelled before 2 April 2025 in accordance with the rules applicable before 2 April 2023 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food producing animals.

Article 3

Entry into force

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

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

Done at Brussels, 10 March 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 268, 18.10.2003, p. 29.

1

(2)  Council Directive 70/524/EEC of 23 November 1970 concerning additives in feedingstuffs (OJ L 270, 14.12.1970, p. 1).

2

(3)  EFSA Journal 2012;10(3):2625.

3

(4)  EFSA Journal 2012;10(5):2678.

4

(5)  EFSA Journal 2012;10(10):2927.

5

(6)  EFSA Journal 2012;10(10):2928.

6

(7)  EFSA Journal 2012;10(11):2966.

7

(8)  EFSA Journal 2013;11(4):3169.

8

(9)  EFSA Journal 2015;13(3):4053.

9

(10)  EFSA Journal 2016;14(6):4441.

10

(11)  EFSA Journal 2016;14(6):4475.

11

(12)  EFSA Journal 2016;14(8):4557.

12

(13)  EFSA Journal 2019;17(3):5654.

13

(14)  EFSA Journal 2020;18(12):6338.

14

(15)  EFSA Journal 2022;20(4):7248.

15

---

ANNEX

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b09093 | Ethyl heptanoate | Additive composition

  Ethyl heptanoate

  Characterisation of active substance

  Ethyl heptanoate
  Produced by chemical synthesis
  Purity: min. 98%
  Chemical formula: C9H18O2

  CAS number: 106-30-9
  FLAVIS: 09.093 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b09093

Ethyl heptanoate

Additive composition

Ethyl heptanoate

Characterisation of active substance

Ethyl heptanoate

Produced by chemical synthesis

Purity: min. 98%

Chemical formula: C9H18O2

CAS number: 106-30-9

FLAVIS: 09.093

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 32 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 32 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (1)

For the determination of ethyl heptanoate in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b09409 | Ethyl 2-methylbutyrate | Additive composition

  Ethyl 2-methylbutyrate

  Characterisation of active substance

  Ethyl 2-methylbutyrate
  Produced by chemical synthesis
  Purity: min. 95%
  Chemical formula: C7H14O2

  CAS number: 7452-79-1
  FLAVIS: 09.409 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b09409

Ethyl 2-methylbutyrate

Additive composition

Ethyl 2-methylbutyrate

Characterisation of active substance

Ethyl 2-methylbutyrate

Produced by chemical synthesis

Purity: min. 95%

Chemical formula: C7H14O2

CAS number: 7452-79-1

FLAVIS: 09.409

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 25 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 25 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (2)

For the determination of ethyl 2-methylbutyrate in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b09024 | Isopentyl acetate | Additive composition

  Isopentyl acetate

  Characterisation of active substance

  Isopentyl acetate
  Produced by chemical synthesis
  Purity: min. 95%
  Chemical formula: C7H14O2

  CAS number: 123-92-2
  FLAVIS: 09.024 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b09024

Isopentyl acetate

Additive composition

Isopentyl acetate

Characterisation of active substance

Isopentyl acetate

Produced by chemical synthesis

Purity: min. 95%

Chemical formula: C7H14O2

CAS number: 123-92-2

FLAVIS: 09.024

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 125 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 125 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (3)

For the determination of isopentyl acetate in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b09463 | 3-Methylbutyl 3-methylbutyrate | Additive composition

  3-Methylbutyl 3-methylbutyrate

  Characterisation of active substance

  3-Methylbutyl 3-methylbutyrate
  Produced by chemical synthesis
  Purity: min. 98%
  Chemical formula: C10H20O2

  CAS number: 659-70-1
  FLAVIS: 09.463 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b09463

3-Methylbutyl 3-methylbutyrate

Additive composition

3-Methylbutyl 3-methylbutyrate

Characterisation of active substance

3-Methylbutyl 3-methylbutyrate

Produced by chemical synthesis

Purity: min. 98%

Chemical formula: C10H20O2

CAS number: 659-70-1

FLAVIS: 09.463

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 25 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 25 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (4)

For the determination of 3-methylbutyl 3-methylbutyrate in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b08006 | 2-Methylpropionic acid | Additive composition

  2-Methylpropionic acid

  Characterisation of active substance

  2-Methylpropionic acid
  Produced by chemical synthesis
  Purity: min. 99%
  Chemical formula: C4H8O2

  CAS number: 79-31-2
  FLAVIS: 08.006 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b08006

2-Methylpropionic acid

Additive composition

2-Methylpropionic acid

Characterisation of active substance

2-Methylpropionic acid

Produced by chemical synthesis

Purity: min. 99%

Chemical formula: C4H8O2

CAS number: 79-31-2

FLAVIS: 08.006

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 25 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 25 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (5)

For the determination of 2-methylpropionic acid in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b09055 | 3-Methylbutyl butyrate | Additive composition

  3-Methylbutyl butyrate

  Characterisation of active substance

  3-Methylbutyl butyrate
  Produced by chemical synthesis
  Purity: min. 98%
  Chemical formula: C9H18O2

  CAS number: 106-27-4
  FLAVIS: 09.055 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b09055

3-Methylbutyl butyrate

Additive composition

3-Methylbutyl butyrate

Characterisation of active substance

3-Methylbutyl butyrate

Produced by chemical synthesis

Purity: min. 98%

Chemical formula: C9H18O2

CAS number: 106-27-4

FLAVIS: 09.055

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 25 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 25 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (6)

For the determination of 3-methylbutyl butyrate in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b09286 | 2-Methylbutyl acetate | Additive composition

  2-Methylbutyl acetate

  Characterisation of active substance

  2-Methylbutyl acetate
  Produced by chemical synthesis
  Purity: min. 99%
  Chemical formula: C7H14O2

  CAS number: 624-41-9
  FLAVIS: 09.286 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b09286

2-Methylbutyl acetate

Additive composition

2-Methylbutyl acetate

Characterisation of active substance

2-Methylbutyl acetate

Produced by chemical synthesis

Purity: min. 99%

Chemical formula: C7H14O2

CAS number: 624-41-9

FLAVIS: 09.286

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 25 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 25 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (7)

For the determination of 2-methylbutyl acetate in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b02020 | Hex-2-en-1-ol | Additive composition

  Hex-2-en-1-ol

  Characterisation of active substance

  Hex-2-en-1-ol
  Produced by chemical synthesis
  Purity: min. 95%
  Chemical formula: C6H12O
  CAS number: 2305-21-7
  FLAVIS: 02.020 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b02020

Hex-2-en-1-ol

Additive composition

Hex-2-en-1-ol

Characterisation of active substance

Hex-2-en-1-ol

Produced by chemical synthesis

Purity: min. 95%

Chemical formula: C6H12O

CAS number: 2305-21-7

FLAVIS: 02.020

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 5 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 5 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (8)

For the determination of hex-2-en-1-ol in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b05073 | Hex-2(trans)-enal | Additive composition

  Hex-2(trans)-enal

  Characterisation of active substance

  Hex-2(trans)-enal
  Produced by chemical synthesis
  Purity: min. 92%
  Chemical formula: C6H10O
  CAS number: 6728-26-3
  FLAVIS: 05.073 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b05073

Hex-2(trans)-enal

Additive composition

Hex-2(trans)-enal

Characterisation of active substance

Hex-2(trans)-enal

Produced by chemical synthesis

Purity: min. 92%

Chemical formula: C6H10O

CAS number: 6728-26-3

FLAVIS: 05.073

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 5 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 5 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (9)

For the determination of hex-2(trans)-enal in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b09244 | Allyl hexanoate | Additive composition

  Allyl hexanoate

  Characterisation of active substance

  Allyl hexanoate
  Produced by chemical synthesis
  Purity: min. 98%
  Chemical formula: C9H16O2

  CAS number: 123-68-2
  FLAVIS: 09.244 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b09244

Allyl hexanoate

Additive composition

Allyl hexanoate

Characterisation of active substance

Allyl hexanoate

Produced by chemical synthesis

Purity: min. 98%

Chemical formula: C9H16O2

CAS number: 123-68-2

FLAVIS: 09.244

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 5 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 5 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (10)

For the determination of allyl hexanoate in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b09097 | Allyl heptanoate | Additive composition

  Allyl heptanoate

  Characterisation of active substance

  Allyl heptanoate
  Produced by chemical synthesis
  Purity: min. 97%
  Chemical formula: C10H18O2

  CAS number: 142-19-8
  FLAVIS: 09.097 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b09097

Allyl heptanoate

Additive composition

Allyl heptanoate

Characterisation of active substance

Allyl heptanoate

Produced by chemical synthesis

Purity: min. 97%

Chemical formula: C10H18O2

CAS number: 142-19-8

FLAVIS: 09.097

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 5 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 5 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by swallow, inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by swallow, inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (11)

For the determination of allyl heptanoate in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b02013 | Linalool | Additive composition

  Linalool

  Characterisation of active substance

  Linalool
  Produced by chemical synthesis or by fractional distillation and subsequent rectification from the oils of Cajenne rosewood, Brazil rosewood, Mexican linaloe, shiu and coriander seeds.
  Purity: min. 95%
  Chemical formula: C10H18O
  CAS number: 78-70-6
  FLAVIS: 02.013 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b02013

Linalool

Additive composition

Linalool

Characterisation of active substance

Linalool

Produced by chemical synthesis or by fractional distillation and subsequent rectification from the oils of Cajenne rosewood, Brazil rosewood, Mexican linaloe, shiu and coriander seeds.

Purity: min. 95%

Chemical formula: C10H18O

CAS number: 78-70-6

FLAVIS: 02.013

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 30 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 30 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (12)

For the determination of linalool in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b02035 | 2-Methyl-1-phenylpropan-2-ol | Additive composition

  2-Methyl-1-phenylpropan-2-ol

  Characterisation of active substance

  2-Methyl-1-phenylpropan-2-ol
  Produced by chemical synthesis
  Purity: min. 97%
  Chemical formula: C10H14O
  CAS number: 100-86-7
  FLAVIS: 02.035 | All animals species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b02035

2-Methyl-1-phenylpropan-2-ol

Additive composition

2-Methyl-1-phenylpropan-2-ol

Characterisation of active substance

2-Methyl-1-phenylpropan-2-ol

Produced by chemical synthesis

Purity: min. 97%

Chemical formula: C10H14O

CAS number: 100-86-7

FLAVIS: 02.035

All animals species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:






  — | animals farmed in marine aquaculture systems: 0.05 mg; |
| --- | --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:

—

animals farmed in marine aquaculture systems: 0.05 mg;

| — | animals farmed in land-based aquaculture systems: 5 mg; |
| --- | --- |

—

animals farmed in land-based aquaculture systems: 5 mg;

| — | other species or categories of animals: 5 mg.’ |
| --- | --- |

—

other species or categories of animals: 5 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:






  — | ‘Intended for animals farmed in marine aquaculture systems’. |
| --- | --- | --- |

5.

On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:

—

‘Intended for animals farmed in marine aquaculture systems’.

| — | ‘Intended for animals farmed in land-based aquaculture systems’ |
| --- | --- |

—

‘Intended for animals farmed in land-based aquaculture systems’

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (13)

For the determination of 2-methyl-1-phenylpropan-2-ol in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b07007 | alpha-Ionone | Additive composition

  alpha-Ionone

  Characterisation of active substance

  alpha-Ionone
  Produced by chemical synthesis
  Purity: min. > 85%
  Chemical formula: C13H20O
  CAS number: 127-41-3
  FLAVIS: 07.007 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b07007

alpha-Ionone

Additive composition

alpha-Ionone

Characterisation of active substance

alpha-Ionone

Produced by chemical synthesis

Purity: min. > 85%

Chemical formula: C13H20O

CAS number: 127-41-3

FLAVIS: 07.007

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 25 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 25 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (14)

For the determination of alpha-ionone in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b07083 | beta-Damascone | Additive composition

  beta-Damascone

  Characterisation of active substance

  beta-Damascone
  Produced by chemical synthesis
  Purity: min. > 90%
  Chemical formula: C13H20O
  CAS number: 23726-92-3
  FLAVIS: 07.083 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b07083

beta-Damascone

Additive composition

beta-Damascone

Characterisation of active substance

beta-Damascone

Produced by chemical synthesis

Purity: min. > 90%

Chemical formula: C13H20O

CAS number: 23726-92-3

FLAVIS: 07.083

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:






  — | animals farmed in marine aquaculture systems: 0.05 mg; |
| --- | --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:

—

animals farmed in marine aquaculture systems: 0.05 mg;

| — | animals farmed in land-based aquaculture systems: 5 mg |
| --- | --- |

—

animals farmed in land-based aquaculture systems: 5 mg

| — | other species or categories of animals: 5 mg.’ |
| --- | --- |

—

other species or categories of animals: 5 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:






  — | ‘Intended for animals farmed in marine aquaculture systems’ |
| --- | --- | --- |

5.

On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:

—

‘Intended for animals farmed in marine aquaculture systems’

| — | ‘Intended for animals farmed in land-based aquaculture systems’ |
| --- | --- |

—

‘Intended for animals farmed in land-based aquaculture systems’

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (15)

For the determination of beta-damascone in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b07089 | Nootkatone | Additive composition

  Nootkatone

  Characterisation of active substance

  Nootkatone
  Produced by chemical synthesis
  Purity: min. > 93%
  Chemical formula: C15H22O
  CAS number: 4674-50-4
  FLAVIS: 07.089 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b07089

Nootkatone

Additive composition

Nootkatone

Characterisation of active substance

Nootkatone

Produced by chemical synthesis

Purity: min. > 93%

Chemical formula: C15H22O

CAS number: 4674-50-4

FLAVIS: 07.089

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 5 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 5 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (16)

For the determination of nootkatone in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b07008 | beta-Ionone | Additive composition

  beta-Ionone

  Characterisation of active substance

  beta-Ionone
  Produced by chemical synthesis
  Purity: min. > 95%
  Chemical formula: C13H20O
  CAS number: 14901-07-6
  FLAVIS: 07.008 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b07008

beta-Ionone

Additive composition

beta-Ionone

Characterisation of active substance

beta-Ionone

Produced by chemical synthesis

Purity: min. > 95%

Chemical formula: C13H20O

CAS number: 14901-07-6

FLAVIS: 07.008

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:






  — | salmonids, veal calves and dogs: 5 mg; |
| --- | --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:

—

salmonids, veal calves and dogs: 5 mg;

| — | other species or categories of animals: 1 mg.’ |
| --- | --- |

—

other species or categories of animals: 1 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (17)

For the determination of beta-ionone in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b07011 | alpha-Irone | Additive composition

  alpha-Irone

  Characterisation of active substance

  alpha-Irone
  Produced by chemical synthesis
  Purity: min. > 98%
  Chemical formula: C14H22O
  CAS number: 79-69-6
  FLAVIS: 07.011 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b07011

alpha-Irone

Additive composition

alpha-Irone

Characterisation of active substance

alpha-Irone

Produced by chemical synthesis

Purity: min. > 98%

Chemical formula: C14H22O

CAS number: 79-69-6

FLAVIS: 07.011

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:






  — | animals farmed in marine aquaculture systems: 0.05 mg; |
| --- | --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:

—

animals farmed in marine aquaculture systems: 0.05 mg;

| — | animals farmed in land-based aquaculture systems: 5 mg; |
| --- | --- |

—

animals farmed in land-based aquaculture systems: 5 mg;

| — | other species or categories of animals: 5 mg.’ |
| --- | --- |

—

other species or categories of animals: 5 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:






  — | ‘Intended for animals farmed in marine aquaculture systems’ |
| --- | --- | --- |

5.

On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:

—

‘Intended for animals farmed in marine aquaculture systems’

| — | ‘Intended for animals farmed in land-based aquaculture systems’ |
| --- | --- |

—

‘Intended for animals farmed in land-based aquaculture systems’

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (18)

For the determination of alpha-irone in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b07108 | beta-Damascenone | Additive composition

  beta-Damascenone

  Characterisation of active substance

  beta-Damascenone
  Produced by chemical synthesis
  Purity: min. > 98%
  Chemical formula: C13H18O
  CAS number: 23696-85-7
  FLAVIS: 07.108 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b07108

beta-Damascenone

Additive composition

beta-Damascenone

Characterisation of active substance

beta-Damascenone

Produced by chemical synthesis

Purity: min. > 98%

Chemical formula: C13H18O

CAS number: 23696-85-7

FLAVIS: 07.108

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:






  — | cattle for fattening, salmonids and non-food producing animals: 1.5 mg; |
| --- | --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:

—

cattle for fattening, salmonids and non-food producing animals: 1.5 mg;

| — | other species and categories: 1 mg.’ |
| --- | --- |

—

other species and categories: 1 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (19)

For the determination of beta-damascenone in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b07224 | (E)-beta-Damascone | Additive composition

  (E)-beta-Damascone

  Characterisation of active substance

  (E)-beta-Damascone
  Produced by chemical synthesis
  Purity: min. > 90%
  Chemical formula: C13H20O
  CAS number: 23726-91-2
  FLAVIS: 07.224 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b07224

(E)-beta-Damascone

Additive composition

(E)-beta-Damascone

Characterisation of active substance

(E)-beta-Damascone

Produced by chemical synthesis

Purity: min. > 90%

Chemical formula: C13H20O

CAS number: 23726-91-2

FLAVIS: 07.224

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:






  — | animals farmed in marine aquaculture systems: 0.05 mg; |
| --- | --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:

—

animals farmed in marine aquaculture systems: 0.05 mg;

| — | animals farmed in land-based aquaculture systems: 5 mg; |
| --- | --- |

—

animals farmed in land-based aquaculture systems: 5 mg;

| — | other species or categories of animals: 5 mg.’ |
| --- | --- |

—

other species or categories of animals: 5 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:






  — | ‘Intended for animals farmed in marine aquaculture systems’ |
| --- | --- | --- |

5.

On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:

—

‘Intended for animals farmed in marine aquaculture systems’

| — | ‘Intended for animals farmed in land-based aquaculture systems’ |
| --- | --- |

—

‘Intended for animals farmed in land-based aquaculture systems’

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (20)

For the determination of (E)-beta-damascone in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b10004 | Pentadecano-1,15-lactone | Additive composition

  Pentadecano-1,15-lactone

  Characterisation of active substance

  Pentadecano-1,15-lactone
  Produced by chemical synthesis
  Purity: min. 98%
  Chemical formula: C15H28O2

  CAS number: 106-02-5
  FLAVIS: 10.004 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b10004

Pentadecano-1,15-lactone

Additive composition

Pentadecano-1,15-lactone

Characterisation of active substance

Pentadecano-1,15-lactone

Produced by chemical synthesis

Purity: min. 98%

Chemical formula: C15H28O2

CAS number: 106-02-5

FLAVIS: 10.004

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 10 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 10 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (21)

For the determination of pentadecano-1,15-lactone in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b02019 | 2-Phenylethan-1-ol | Additive composition

  2-Phenylethan-1-ol

  Characterisation of active substance

  2-Phenylethan-1-ol
  Produced by chemical synthesis
  Purity: min. 98%
  Chemical formula: C8H10O
  CAS number: 60-12-8
  FLAVIS: 02.019 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b02019

2-Phenylethan-1-ol

Additive composition

2-Phenylethan-1-ol

Characterisation of active substance

2-Phenylethan-1-ol

Produced by chemical synthesis

Purity: min. 98%

Chemical formula: C8H10O

CAS number: 60-12-8

FLAVIS: 02.019

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 25 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 25 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (22)

For the determination of 2-phenylethan-1-ol in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b09466 | Phenethyl isovalerate | Additive composition

  Phenethyl isovalerate

  Characterisation of active substance

  Phenethyl isovalerate
  Produced by chemical synthesis
  Purity: min. > 97%
  Chemical formula: C13H18O2

  CAS number: 140-26-1
  FLAVIS: 09.466 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b09466

Phenethyl isovalerate

Additive composition

Phenethyl isovalerate

Characterisation of active substance

Phenethyl isovalerate

Produced by chemical synthesis

Purity: min. > 97%

Chemical formula: C13H18O2

CAS number: 140-26-1

FLAVIS: 09.466

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:






  — | animals farmed in marine aquaculture systems: 0.05 mg; |
| --- | --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:

—

animals farmed in marine aquaculture systems: 0.05 mg;

| — | animals farmed in land-based aquaculture systems: 30 mg; |
| --- | --- |

—

animals farmed in land-based aquaculture systems: 30 mg;

| — | other species or categories of animals: 30 mg.’ |
| --- | --- |

—

other species or categories of animals: 30 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:






  — | ‘Intended for animals farmed in marine aquaculture systems’ |
| --- | --- | --- |

5.

On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:

—

‘Intended for animals farmed in marine aquaculture systems’

| — | ‘Intended for animals farmed in land-based aquaculture systems’ |
| --- | --- |

—

‘Intended for animals farmed in land-based aquaculture systems’

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (23)

For the determination of phenethyl isovalerate in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b07055 | 4-(p-Hydroxyphenyl)butan-2-one | Additive composition

  4-(p-Hydroxyphenyl)butan-2-one

  Characterisation of active substance

  4-(p-Hydroxyphenyl)butan-2-one
  Produced by chemical synthesis
  Purity: min. > 96%
  Chemical formula: C10H12O2

  CAS number: 5471-51-2
  FLAVIS: 07.055 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b07055

4-(p-Hydroxyphenyl)butan-2-one

Additive composition

4-(p-Hydroxyphenyl)butan-2-one

Characterisation of active substance

4-(p-Hydroxyphenyl)butan-2-one

Produced by chemical synthesis

Purity: min. > 96%

Chemical formula: C10H12O2

CAS number: 5471-51-2

FLAVIS: 07.055

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:






  — | animals farmed in marine aquaculture systems: 0.05 mg; |
| --- | --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:

—

animals farmed in marine aquaculture systems: 0.05 mg;

| — | animals farmed in land-based aquaculture systems: 25 mg |
| --- | --- |

—

animals farmed in land-based aquaculture systems: 25 mg

| — | other species or categories of animals: 25 mg.’ |
| --- | --- |

—

other species or categories of animals: 25 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:






  — | ‘Intended for animals farmed in marine aquaculture systems’ |
| --- | --- | --- |

5.

On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:

—

‘Intended for animals farmed in marine aquaculture systems’

| — | ‘Intended for animals farmed in land-based aquaculture systems’ |
| --- | --- |

—

‘Intended for animals farmed in land-based aquaculture systems’

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (24)

For the determination of 4-(p-hydroxyphenyl)butan-2-one in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b04074 | 2-Methoxynaphthalene | Additive composition

  2-Methoxynaphthalene

  Characterisation of active substance

  2-Methoxynaphthalene
  Produced by chemical synthesis
  Purity: min. 99%
  Chemical formula: C11H10O
  CAS number: 93-04-9
  FLAVIS: 04.074 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b04074

2-Methoxynaphthalene

Additive composition

2-Methoxynaphthalene

Characterisation of active substance

2-Methoxynaphthalene

Produced by chemical synthesis

Purity: min. 99%

Chemical formula: C11H10O

CAS number: 93-04-9

FLAVIS: 04.074

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 1.2 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 1.2 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (25)

For the determination of 2-methoxynaphthalene in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b15026 | 2-Isopropyl-4-methylthiazole | Additive composition

  2-Isopropyl-4-methylthiazole

  Characterisation of active substance

  2-Isopropyl-4-methylthiazole
  Produced by chemical synthesis
  Purity: min. 96%
  Chemical formula: C7H11NS
  CAS number: 15679-13-7
  FLAVIS: 15.026 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b15026

2-Isopropyl-4-methylthiazole

Additive composition

2-Isopropyl-4-methylthiazole

Characterisation of active substance

2-Isopropyl-4-methylthiazole

Produced by chemical synthesis

Purity: min. 96%

Chemical formula: C7H11NS

CAS number: 15679-13-7

FLAVIS: 15.026

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:






  — | animals farmed in marine aquaculture systems: 0.05 mg; |
| --- | --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%:

—

animals farmed in marine aquaculture systems: 0.05 mg;

| — | animals farmed in land-based aquaculture systems:1.5mg |
| --- | --- |

—

animals farmed in land-based aquaculture systems:1.5mg

| — | other species or categories of animals: 1.5 mg.’ |
| --- | --- |

—

other species or categories of animals: 1.5 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:






  — | ‘Intended for animals farmed in marine aquaculture systems’ |
| --- | --- | --- |

5.

On the label of premixtures, of feed materials and of compound feed intended for aquatic species, the following shall be indicated, where applicable:

—

‘Intended for animals farmed in marine aquaculture systems’

| — | ‘Intended for animals farmed in land-based aquaculture systems’ |
| --- | --- |

—

‘Intended for animals farmed in land-based aquaculture systems’

| 6. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

6.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (26)

For the determination of 2-isopropyl-4-methylthiazole in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

| Identification number of the additive | Additive | Composition, chemical formula, description, analytical method | Species or category of animal | Maximum age | Minimum content | Maximum content | Other provisions | End of period of authorisation |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| mg of additive/kg of complete feedingstuff with a moisture content of 12% |
| Category: Sensory additives. Functional group: Flavouring compounds |
| 2b01017 | Valencene | Additive composition

  Valencene

  Characterisation of active substance

  Valencene
  Produced by chemical synthesis
  Purity: min. 94%
  Chemical formula: C15H24

  CAS number: 4630-07-3
  FLAVIS: 01.017 | All animal species | - | - | - | 1. | The additive shall be incorporated into the feed in the form of a premixture. |

Identification number of the additive

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg of additive/kg of complete feedingstuff with a moisture content of 12%

Category: Sensory additives. Functional group: Flavouring compounds

2b01017

Valencene

Additive composition

Valencene

Characterisation of active substance

Valencene

Produced by chemical synthesis

Purity: min. 94%

Chemical formula: C15H24

CAS number: 4630-07-3

FLAVIS: 01.017

All animal species

-

-

-

1.

The additive shall be incorporated into the feed in the form of a premixture.

| 2. | In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated. |
| --- | --- |

2.

In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.

| 3. | On the label of the additive, the following shall be indicated:
  ‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 5 mg.’ |
| --- | --- |

3.

On the label of the additive, the following shall be indicated:

‘Recommended maximum content of the active substance per kg of complete feedingstuff with a moisture content of 12%: 5 mg.’

| 4. | The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3. |
| --- | --- |

4.

The functional group, the identification number, the name and the added amount of the active substance shall be indicated on the label of the premixture where the use level on the label of the premixture would result in exceeding the level referred to in point 3.

| 5. | For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection. |
| --- | --- |

5.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including skin, eye and breathing protection.

2 April 2033

Analytical method
   (27)

For the determination of valencene in the feed additive and in feed flavouring premixtures:

| — | Gas chromatography mass spectrometry with retention time locking GC-MS-RTL. |
| --- | --- |

—

Gas chromatography mass spectrometry with retention time locking GC-MS-RTL.

---

(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(2)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(3)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(4)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(5)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(6)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(7)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

(8)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(9)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(10)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(11)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(12)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(13)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

(14)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(15)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports

(16)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(17)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(18)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(19)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(20)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(21)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(22)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(23)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(24)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(25)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(26)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

(27)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

---

| 13.3.2023 | EN | Official Journal of the European Union | L 74/47 |
| --- | --- | --- | --- |

13.3.2023

EN

Official Journal of the European Union

L 74/47

---

COMMISSION IMPLEMENTING REGULATION (EU) 2023/566

of 10 March 2023

amending Implementing Regulation (EU) 2015/1998 as regards certain detailed measures for the implementation of the common basic standards on aviation security

(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 300/2008 of the European Parliament and of the Council of 11 March 2008 on common rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (1), and in particular Article 4(3) thereof,

Whereas:

| (1) | Experience gained with the implementation of Commission Implementing Regulation (EU) 2015/1998 (2) has shown the need for minor amendments to the implementing modalities of certain common basic standards on aviation security. |
| --- | --- |

(1)

Experience gained with the implementation of Commission Implementing Regulation (EU) 2015/1998 (2) has shown the need for minor amendments to the implementing modalities of certain common basic standards on aviation security.

| (2) | Certain detailed aviation security measures should be clarified, harmonised or simplified in order to improve legal clarity, standardise the common interpretation of the relevant provisions and further ensure the best implementation of the common basic standards on aviation security. Furthermore, certain amendments have become necessary in accordance with the evolution of the threat and risk picture as well as recent developments in terms of technology. Those amendments concern automated prohibited items detection (APID) software, explosive detection systems (EDS) for cabin baggage, explosive trace detection (ETD) equipment, security scanners as well as explosive vapour detection (EVD) equipment. |
| --- | --- |

(2)

Certain detailed aviation security measures should be clarified, harmonised or simplified in order to improve legal clarity, standardise the common interpretation of the relevant provisions and further ensure the best implementation of the common basic standards on aviation security. Furthermore, certain amendments have become necessary in accordance with the evolution of the threat and risk picture as well as recent developments in terms of technology. Those amendments concern automated prohibited items detection (APID) software, explosive detection systems (EDS) for cabin baggage, explosive trace detection (ETD) equipment, security scanners as well as explosive vapour detection (EVD) equipment.

| (3) | Experience gained with the implementation of Implementing Regulation (EU) 2015/1998 has shown the need for some amendments to the implementing modalities of certain common basic standards in the areas of certification of instructors delivering training, to remove obsolete references in Attachment 6-E, and clarifications with regards the implementation of referral actions under the Pre-Loading Advance Cargo Information (PLACI) in the Annex to that Regulation. The related provisions in the Annex need to be adjusted in order to improve legal clarity, standardise the common interpretation of the legislation and further ensure the best implementation of the common basic standards in aviation security. |
| --- | --- |

(3)

Experience gained with the implementation of Implementing Regulation (EU) 2015/1998 has shown the need for some amendments to the implementing modalities of certain common basic standards in the areas of certification of instructors delivering training, to remove obsolete references in Attachment 6-E, and clarifications with regards the implementation of referral actions under the Pre-Loading Advance Cargo Information (PLACI) in the Annex to that Regulation. The related provisions in the Annex need to be adjusted in order to improve legal clarity, standardise the common interpretation of the legislation and further ensure the best implementation of the common basic standards in aviation security.

| (4) | Implementing Regulation (EU) 2015/1998 should therefore be amended accordingly. |
| --- | --- |

(4)

Implementing Regulation (EU) 2015/1998 should therefore be amended accordingly.

| (5) | The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 19 of Regulation (EC) No 300/2008, |
| --- | --- |

(5)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 19 of Regulation (EC) No 300/2008,

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2015/1998 is amended in accordance with the Annex to this Regulation.

Article 2

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

It shall apply from 1 April 2023.

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

Done at Brussels, 10 March 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 97, 9.4.2008, p. 72.

1

(2)  Commission Implementing Regulation (EU) 2015/1998 of 5 November 2015 laying down detailed measures for the implementation of the common basic standards on aviation security (OJ L 299, 14.11.2015, p. 1).

2

---

ANNEX

The Annex to Implementing Regulation (EU) 2015/1998 is amended as follows:

| (1) | points 1.3.1.4 and 1.3.1.5 are replaced by the following:






  ‘1.3.1.4. | Items carried by persons other than passengers shall be screened by one of the following means:






  (a) | hand search; |
| --- | --- | --- | --- |

(1)

points 1.3.1.4 and 1.3.1.5 are replaced by the following:

‘1.3.1.4.

Items carried by persons other than passengers shall be screened by one of the following means:

(a)

hand search;

| (b) | x-ray equipment; |
| --- | --- |

(b)

x-ray equipment;

| (c) | explosive detection systems (EDS) equipment; |
| --- | --- |

(c)

explosive detection systems (EDS) equipment;

| (d) | automated prohibited items detection (APID) software in combination with point (c); |
| --- | --- |

(d)

automated prohibited items detection (APID) software in combination with point (c);

| (e) | explosive detection dogs; |
| --- | --- |

(e)

explosive detection dogs;

| (f) | explosive trace detection (ETD) equipment. |
| --- | --- |

(f)

explosive trace detection (ETD) equipment.

Where the screener cannot determine whether or not the items carried contains any prohibited articles, it shall be rejected or rescreened to the screener’s satisfaction.

| 1.3.1.5. | Points 4.1.2.4 to 4.1.2.7 and 4.1.2.11 to 4.1.2.12 shall apply to the screening of items carried by persons other than passengers.’; |
| --- | --- |

1.3.1.5.

Points 4.1.2.4 to 4.1.2.7 and 4.1.2.11 to 4.1.2.12 shall apply to the screening of items carried by persons other than passengers.’;

| (2) | point 4.1.1.1 is replaced by the following:






  ‘4.1.1.1. | Before screening, outer wear shall be taken off and shall be screened as cabin baggage, unless the concept of operations of equipment allows for outer wear to be kept on. The screener may request the passenger to undertake further divesting as appropriate.’; |
| --- | --- | --- |

(2)

point 4.1.1.1 is replaced by the following:

‘4.1.1.1.

Before screening, outer wear shall be taken off and shall be screened as cabin baggage, unless the concept of operations of equipment allows for outer wear to be kept on. The screener may request the passenger to undertake further divesting as appropriate.’;

| (3) | point 4.1.2.3 is replaced by the following:






  ‘4.1.2.3. | Cabin baggage shall be screened by at least one of the following methods:






  (a) | a hand search; |
| --- | --- | --- | --- |

(3)

point 4.1.2.3 is replaced by the following:

‘4.1.2.3.

Cabin baggage shall be screened by at least one of the following methods:

(a)

a hand search;

| (b) | x-ray equipment; |
| --- | --- |

(b)

x-ray equipment;

| (c) | explosive detection systems (EDS) equipment; |
| --- | --- |

(c)

explosive detection systems (EDS) equipment;

| (d) | automated prohibited items detection (APID) software in combination with point (c); |
| --- | --- |

(d)

automated prohibited items detection (APID) software in combination with point (c);

| (e) | explosive detection dogs in combination with point (a); |
| --- | --- |

(e)

explosive detection dogs in combination with point (a);

| (f) | ETD equipment. |
| --- | --- |

(f)

ETD equipment.

Where the screener cannot determine whether or not the cabin baggage contains any prohibited articles, it shall be rejected or rescreened to the screener’s satisfaction.’;

| (4) | points 4.1.2.5 and 4.1.2.6 are replaced by the following:






  ‘4.1.2.5. | Where x-ray equipment is used, each image shall be viewed by the screener.
  Where EDS equipment is used, each image shall be viewed by the screener or analysed by automated prohibited items detection (APID) software. |
| --- | --- | --- |

(4)

points 4.1.2.5 and 4.1.2.6 are replaced by the following:

‘4.1.2.5.

Where x-ray equipment is used, each image shall be viewed by the screener.

Where EDS equipment is used, each image shall be viewed by the screener or analysed by automated prohibited items detection (APID) software.

| 4.1.2.6. | Where APID software is used, all alarms as referred to in point 12.13.1.1 shall be resolved to the satisfaction of the screener so as to reasonably ensure that no prohibited articles are carried into the SRA or on board an aircraft.
  Where EDS equipment is used, all alarms as referred to in point 12.4.1.3 shall be resolved by screening the baggage again using an additional screening method.
  Where EDS equipment has been installed before 1 July 2023 and is used without APID software, all alarms as referred to in point 12.4.1.3 shall be resolved to the satisfaction of the screener so as to reasonably ensure that no prohibited articles are carried into the SRA or on board an aircraft. When the identity of an article is unclear, the alarms shall be resolved by screening the baggage again using an additional screening method.’; |
| --- | --- |

4.1.2.6.

Where APID software is used, all alarms as referred to in point 12.13.1.1 shall be resolved to the satisfaction of the screener so as to reasonably ensure that no prohibited articles are carried into the SRA or on board an aircraft.

Where EDS equipment is used, all alarms as referred to in point 12.4.1.3 shall be resolved by screening the baggage again using an additional screening method.

Where EDS equipment has been installed before 1 July 2023 and is used without APID software, all alarms as referred to in point 12.4.1.3 shall be resolved to the satisfaction of the screener so as to reasonably ensure that no prohibited articles are carried into the SRA or on board an aircraft. When the identity of an article is unclear, the alarms shall be resolved by screening the baggage again using an additional screening method.’;

| (5) | point 4.1.2.12 is replaced by the following:






  ‘4.1.2.12. | Where APID software is used in combination with EDS equipment meeting either of standards C1, C1+, C2 or C2+, the operator or entity using equipment shall ensure that the procedures are in accordance with the concept of operations of these standards as regards screening of large electronic items and screening of LAGs.’; |
| --- | --- | --- |

(5)

point 4.1.2.12 is replaced by the following:

‘4.1.2.12.

Where APID software is used in combination with EDS equipment meeting either of standards C1, C1+, C2 or C2+, the operator or entity using equipment shall ensure that the procedures are in accordance with the concept of operations of these standards as regards screening of large electronic items and screening of LAGs.’;

| (6) | the following point 4.1.2.13 is added:






  ‘4.1.2.13. | The screening of cabin baggage shall also be subject to the additional provisions laid down in Commission Implementing Decision C(2015) 8005.’; |
| --- | --- | --- |

(6)

the following point 4.1.2.13 is added:

‘4.1.2.13.

The screening of cabin baggage shall also be subject to the additional provisions laid down in Commission Implementing Decision C(2015) 8005.’;

| (7) | point 6.2.1.5 is amended as follows:






  (a) | point (g) is replaced by the following:






  ‘(g) | metal detection equipment (MDE);’; |
| --- | --- | --- | --- |

(7)

point 6.2.1.5 is amended as follows:

(a)

point (g) is replaced by the following:

‘(g)

metal detection equipment (MDE);’;

| (b) | the following point is added:






  ‘(h) | EVD equipment.’; |
| --- | --- | --- |

(b)

the following point is added:

‘(h)

EVD equipment.’;

| (8) | in point 6.3.2.6 (e), point (iv) is replaced by the following:






  ‘(iv) | the means or method of screening used, as follows:






  — | hand search (PHS); |
| --- | --- | --- | --- |

(8)

in point 6.3.2.6 (e), point (iv) is replaced by the following:

‘(iv)

the means or method of screening used, as follows:

—

hand search (PHS);

| — | X-ray equipment (XRY); |
| --- | --- |

—

X-ray equipment (XRY);

| — | EDS equipment (EDS); |
| --- | --- |

—

EDS equipment (EDS);

| — | explosive detection dogs (EDD); |
| --- | --- |

—

explosive detection dogs (EDD);

| — | ETD equipment (ETD); |
| --- | --- |

—

ETD equipment (ETD);

| — | visual check (VCK); |
| --- | --- |

—

visual check (VCK);

| — | metal detection equipment (CMD); |
| --- | --- |

—

metal detection equipment (CMD);

| — | EVD equipment (EVD); |
| --- | --- |

—

EVD equipment (EVD);

| — | any other method (AOM) in accordance with point 6.2.1.6 where the method used shall be specified; or’; |
| --- | --- |

—

any other method (AOM) in accordance with point 6.2.1.6 where the method used shall be specified; or’;

| (9) | in point 6.8.7.2, the following sentence is added:
  ‘An air carrier shall not load for carriage into the Union such consignment, unless the required measures as set out in points 6.8.7.3 and 6.8.7.4, as applicable, have been implemented satisfactorily.’; |
| --- | --- |

(9)

in point 6.8.7.2, the following sentence is added:

‘An air carrier shall not load for carriage into the Union such consignment, unless the required measures as set out in points 6.8.7.3 and 6.8.7.4, as applicable, have been implemented satisfactorily.’;

| (10) | Attachment 6-E, second paragraph, is amended as follows:






  (a) | the introductory wording is replaced by the following:
  ‘When collecting, carrying, storing and delivering air cargo/mail to which security controls have been applied [on behalf of name of regulated agent/air carrier applying security controls for cargo or mail/known consignor], I confirm that the following security procedures will be adhered to:’; |
| --- | --- | --- |

(10)

Attachment 6-E, second paragraph, is amended as follows:

(a)

the introductory wording is replaced by the following:

‘When collecting, carrying, storing and delivering air cargo/mail to which security controls have been applied [on behalf of name of regulated agent/air carrier applying security controls for cargo or mail/known consignor], I confirm that the following security procedures will be adhered to:’;

| (b) | the seventh indent is amended as follows:






  (1) | point (a) is replaced by the following:






  ‘(a) | has a haulier agreement with the regulated agent or known consignor responsible for the transport [same name as above]; or’; |
| --- | --- | --- | --- |

(b)

the seventh indent is amended as follows:

(1)

point (a) is replaced by the following:

‘(a)

has a haulier agreement with the regulated agent or known consignor responsible for the transport [same name as above]; or’;

| (2) | point (c) is replaced by the following:






  ‘(c) | has a haulier agreement with the undersigned haulier requiring that the third party will not subcontract further and implements the security procedures contained in this declaration. The undersigned haulier retains full responsibility for the entire transport on behalf of the regulated agent or known consignor; and’; |
| --- | --- | --- |

(2)

point (c) is replaced by the following:

‘(c)

has a haulier agreement with the undersigned haulier requiring that the third party will not subcontract further and implements the security procedures contained in this declaration. The undersigned haulier retains full responsibility for the entire transport on behalf of the regulated agent or known consignor; and’;

| (11) | point 8.1.2.3 is amended as follows:






  (a) | point (f) is replaced by the following:






  ‘(f) | explosive detection dogs in combination with point (a);’; |
| --- | --- | --- | --- |

(11)

point 8.1.2.3 is amended as follows:

(a)

point (f) is replaced by the following:

‘(f)

explosive detection dogs in combination with point (a);’;

| (b) | the following point (g) is added:






  ‘(g) | EVD equipment applied in accordance with the relevant provisions contained in Attachment 6-J and in combination with point (a).’; |
| --- | --- | --- |

(b)

the following point (g) is added:

‘(g)

EVD equipment applied in accordance with the relevant provisions contained in Attachment 6-J and in combination with point (a).’;

| (12) | point 9.1.2.3 is amended as follows:






  (a) | point (f) is replaced by the following:






  ‘(f) | explosive detection dogs in combination with point (a);’; |
| --- | --- | --- | --- |

(12)

point 9.1.2.3 is amended as follows:

(a)

point (f) is replaced by the following:

‘(f)

explosive detection dogs in combination with point (a);’;

| (b) | the following point (g) is added:






  ‘(g) | EVD equipment applied in accordance with the relevant provisions contained in Attachment 6-J and in combination with point (a).’; |
| --- | --- | --- |

(b)

the following point (g) is added:

‘(g)

EVD equipment applied in accordance with the relevant provisions contained in Attachment 6-J and in combination with point (a).’;

| (13) | in point 11.5.1, the second sentence is replaced by:
  ‘Certification shall at least apply to those instructors authorised to give training defined in points 11.2.3.1 to 11.2.3.5 and in points 11.2.4 (unless it concerns the training of supervisors exclusively supervising persons referred to in points 11.2.3.6 to 11.2.3.11) and 11.2.5.’; |
| --- | --- |

(13)

in point 11.5.1, the second sentence is replaced by:

‘Certification shall at least apply to those instructors authorised to give training defined in points 11.2.3.1 to 11.2.3.5 and in points 11.2.4 (unless it concerns the training of supervisors exclusively supervising persons referred to in points 11.2.3.6 to 11.2.3.11) and 11.2.5.’;

| (14) | point 12.0.2.1 is replaced by:






  ‘12.0.2.1. | Subject to point 12.0.5, the following security equipment and software may be installed after 1 October 2020 only if it has been granted an ‘EU Stamp’ marking or an ‘EU Stamp pending’ marking status as referred to in point 12.0.2.5:






  (a) | walk-through metal detection (WTMD) equipment; |
| --- | --- | --- | --- |

(14)

point 12.0.2.1 is replaced by:

‘12.0.2.1.

Subject to point 12.0.5, the following security equipment and software may be installed after 1 October 2020 only if it has been granted an ‘EU Stamp’ marking or an ‘EU Stamp pending’ marking status as referred to in point 12.0.2.5:

(a)

walk-through metal detection (WTMD) equipment;

| (b) | explosive detection systems (EDS) equipment; |
| --- | --- |

(b)

explosive detection systems (EDS) equipment;

| (c) | explosive trace detection (ETD) equipment; |
| --- | --- |

(c)

explosive trace detection (ETD) equipment;

| (d) | liquid explosive detection systems (LEDS) equipment; |
| --- | --- |

(d)

liquid explosive detection systems (LEDS) equipment;

| (e) | metal detection equipment (MDE); |
| --- | --- |

(e)

metal detection equipment (MDE);

| (f) | security scanners; |
| --- | --- |

(f)

security scanners;

| (g) | shoe scanner equipment; |
| --- | --- |

(g)

shoe scanner equipment;

| (h) | explosive vapour detection (EVD) equipment; |
| --- | --- |

(h)

explosive vapour detection (EVD) equipment;

| (i) | automated prohibited items detections (APID) software.’; |
| --- | --- |

(i)

automated prohibited items detections (APID) software.’;

| (15) | point 12.4.1.1 is replaced by the following:






  ‘12.4.1.1. | Explosive detection systems equipment (EDS) shall be able to detect and to indicate by means of an alarm specified and higher individual quantities of explosive or chemical material contained in baggage or other consignments.’; |
| --- | --- | --- |

(15)

point 12.4.1.1 is replaced by the following:

‘12.4.1.1.

Explosive detection systems equipment (EDS) shall be able to detect and to indicate by means of an alarm specified and higher individual quantities of explosive or chemical material contained in baggage or other consignments.’;

| (16) | point 12.4.1.2 is replaced by the following:






  ‘12.4.1.2. | The detection shall be independent of the shape, position or orientation of the explosive or chemical material.’; |
| --- | --- | --- |

(16)

point 12.4.1.2 is replaced by the following:

‘12.4.1.2.

The detection shall be independent of the shape, position or orientation of the explosive or chemical material.’;

| (17) | in point 12.4.1.3, the first and the second indents are replaced by the following:






  ‘— | when it detects explosive or chemical material, and |
| --- | --- | --- |

(17)

in point 12.4.1.3, the first and the second indents are replaced by the following:

‘—

when it detects explosive or chemical material, and

| — | when it detects the presence of an item that prevents explosive or chemical material from being detected, and’; |
| --- | --- |

—

when it detects the presence of an item that prevents explosive or chemical material from being detected, and’;

| (18) | point 12.6.1 is amended as follows:






  (a) | the first sentence is replaced by the following:
  ‘ETD equipment shall be able to collect and analyse trace levels of particles from contaminated surfaces, or the contents of baggage or consignments, and indicate, by means of an alarm, the presence of explosives or chemicals.’; |
| --- | --- | --- |

(18)

point 12.6.1 is amended as follows:

(a)

the first sentence is replaced by the following:

‘ETD equipment shall be able to collect and analyse trace levels of particles from contaminated surfaces, or the contents of baggage or consignments, and indicate, by means of an alarm, the presence of explosives or chemicals.’;

| (b) | the sentence following point (b) is replaced by the following:
  ‘There shall be standards for ETD set for particulate sampling. Detailed requirements for these standards are laid down in Commission Implementing Decision C(2015) 8005.’; |
| --- | --- |

(b)

the sentence following point (b) is replaced by the following:

‘There shall be standards for ETD set for particulate sampling. Detailed requirements for these standards are laid down in Commission Implementing Decision C(2015) 8005.’;

| (19) | point 12.6.2 is replaced by the following:






  ‘12.6.2. | The standard for ETD equipment for the detection of explosives, that uses particulate sampling, shall apply to ETD equipment deployed from 1 September 2014.
  The standard for ETD equipment for the detection of chemicals, that uses particulate sampling, shall apply as of 1 July 2024 to ETD equipment deployed from 1 September 2014.’; |
| --- | --- | --- |

(19)

point 12.6.2 is replaced by the following:

‘12.6.2.

The standard for ETD equipment for the detection of explosives, that uses particulate sampling, shall apply to ETD equipment deployed from 1 September 2014.

The standard for ETD equipment for the detection of chemicals, that uses particulate sampling, shall apply as of 1 July 2024 to ETD equipment deployed from 1 September 2014.’;

| (20) | Chapters 12.13 and 12.14 are replaced by the following:






  ‘12.13. | AUTOMATED PROHIBITED ITEMS DETECTION (APID) SOFTWARE |
| --- | --- | --- |

(20)

Chapters 12.13 and 12.14 are replaced by the following:

‘12.13.

AUTOMATED PROHIBITED ITEMS DETECTION (APID) SOFTWARE

| 12.13.1. | General principles |
| --- | --- |

12.13.1.

General principles

| 12.13.1.1. | Automated Prohibited Items Detection (APID) software shall be able to detect and to indicate by means of an alarm prohibited items contained in baggage or other consignments. |
| --- | --- |

12.13.1.1.

Automated Prohibited Items Detection (APID) software shall be able to detect and to indicate by means of an alarm prohibited items contained in baggage or other consignments.

| 12.13.2. | Standards for APID software |
| --- | --- |

12.13.2.

Standards for APID software

| 12.13.2.1. | There shall be three standards for APID software. Detailed requirements on these standards are laid down in Commission Implementing Decision C(2015) 8005. |
| --- | --- |

12.13.2.1.

There shall be three standards for APID software. Detailed requirements on these standards are laid down in Commission Implementing Decision C(2015) 8005.

| 12.14. | EXPLOSIVE VAPOUR DETECTION (EVD) EQUIPMENT |
| --- | --- |

12.14.

EXPLOSIVE VAPOUR DETECTION (EVD) EQUIPMENT

| 12.14.1. | General principles |
| --- | --- |

12.14.1.

General principles

| 12.14.1.1. | Explosives Vapour Detection (EVD) equipment shall be able to collect samples of air and analyse the collected sample for vapour, aerosols and/or airborne particles indicating the presence of explosives and explosive related materials.
  If trace levels of explosives or explosive related materials are found in the sample, the EVD equipment shall indicate an alarm. |
| --- | --- |

12.14.1.1.

Explosives Vapour Detection (EVD) equipment shall be able to collect samples of air and analyse the collected sample for vapour, aerosols and/or airborne particles indicating the presence of explosives and explosive related materials.

If trace levels of explosives or explosive related materials are found in the sample, the EVD equipment shall indicate an alarm.

| 12.14.1.2. | For the purpose of screening with EVD equipment, the following requirements shall apply:






  (a) | EVD equipment shall only be used in an environment and for the purpose for which it has been approved, i.e. screening of:






  — | Passengers and persons other than passengers (EVD-PX); |
| --- | --- | --- | --- |

12.14.1.2.

For the purpose of screening with EVD equipment, the following requirements shall apply:

(a)

EVD equipment shall only be used in an environment and for the purpose for which it has been approved, i.e. screening of:

—

Passengers and persons other than passengers (EVD-PX);

| — | Cabin baggage (EVD-CB); |
| --- | --- |

—

Cabin baggage (EVD-CB);

| — | Hold baggage (EVD-HB); |
| --- | --- |

—

Hold baggage (EVD-HB);

| — | Air cargo and mail, air carrier mail and air carrier materials, in-flight supplies and airport supplies (EVD-CS); |
| --- | --- |

—

Air cargo and mail, air carrier mail and air carrier materials, in-flight supplies and airport supplies (EVD-CS);

| (b) | consumables shall not be used beyond the recommendations of their manufacturer or if the performance of the consumable appears to have deteriorated through use. |
| --- | --- |

(b)

consumables shall not be used beyond the recommendations of their manufacturer or if the performance of the consumable appears to have deteriorated through use.

| 12.14.2. | Standards for EVD |
| --- | --- |

12.14.2.

Standards for EVD

| 12.14.2.1. | All EVD equipment used for the screening of hold baggage, air cargo and mail, air carrier mail and air carrier materials loaded in the aircraft hold, in-flight supplies as well as airport supplies shall meet at least standard 1. |
| --- | --- |

12.14.2.1.

All EVD equipment used for the screening of hold baggage, air cargo and mail, air carrier mail and air carrier materials loaded in the aircraft hold, in-flight supplies as well as airport supplies shall meet at least standard 1.

| 12.14.2.2. | All EVD equipment used for the screening of passengers and persons other than passengers as well as cabin baggage shall meet at least standard 3. |
| --- | --- |

12.14.2.2.

All EVD equipment used for the screening of passengers and persons other than passengers as well as cabin baggage shall meet at least standard 3.

| 12.14.2.3. | Detailed requirements on these standards are laid down in Commission Implementing Decision C(2015) 8005.’; |
| --- | --- |

12.14.2.3.

Detailed requirements on these standards are laid down in Commission Implementing Decision C(2015) 8005.’;

| (21) | Attachment 12-M is replaced by the following: | ‘ATTACHMENT 12-M |
| --- | --- | --- |

(21)

Attachment 12-M is replaced by the following:

‘ATTACHMENT 12-M

| | Detailed provisions for performance requirements for APID are laid down in Commission Implementing Decision C(2015) 8005.’ |
| --- | --- |

Detailed provisions for performance requirements for APID are laid down in Commission Implementing Decision C(2015) 8005.’

---

DECISIONS

| 13.3.2023 | EN | Official Journal of the European Union | L 74/53 |
| --- | --- | --- | --- |

13.3.2023

EN

Official Journal of the European Union

L 74/53

---

COUNCIL DECISION (EU) 2023/567

of 9 March 2023

on the position to be taken, on behalf of the European Union, in the 66th session of the Commission on Narcotic Drugs on the scheduling of substances under the Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol, and the Convention on Psychotropic Substances of 1971

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 83(1), in conjunction with Article 218(9) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | The United Nations (UN) Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol (‘the Convention on Narcotic Drugs’) entered into force on 8 August 1975. |
| --- | --- |

(1)

The United Nations (UN) Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol (‘the Convention on Narcotic Drugs’) entered into force on 8 August 1975.

| (2) | Pursuant to Article 3 of the Convention on Narcotic Drugs, the Commission on Narcotic Drugs may decide to add substances to the Schedules of that Convention. It can make changes in the Schedules only in accordance with the recommendations of the World Health Organisation (‘WHO’), but it can also decide not to make the changes recommended by the WHO. |
| --- | --- |

(2)

Pursuant to Article 3 of the Convention on Narcotic Drugs, the Commission on Narcotic Drugs may decide to add substances to the Schedules of that Convention. It can make changes in the Schedules only in accordance with the recommendations of the World Health Organisation (‘WHO’), but it can also decide not to make the changes recommended by the WHO.

| (3) | The UN Convention on Psychotropic Substances of 1971 (‘the Convention on Psychotropic Substances’) entered into force on 16 August 1976. |
| --- | --- |

(3)

The UN Convention on Psychotropic Substances of 1971 (‘the Convention on Psychotropic Substances’) entered into force on 16 August 1976.

| (4) | Pursuant to Article 2 of the Convention on Psychotropic Substances, the Commission on Narcotic Drugs may decide to add substances to the Schedules of that Convention or to remove them, on the basis of the recommendations of the WHO. It has broad discretionary powers to take into account economic, social, legal, administrative and other factors, but may not act arbitrarily. |
| --- | --- |

(4)

Pursuant to Article 2 of the Convention on Psychotropic Substances, the Commission on Narcotic Drugs may decide to add substances to the Schedules of that Convention or to remove them, on the basis of the recommendations of the WHO. It has broad discretionary powers to take into account economic, social, legal, administrative and other factors, but may not act arbitrarily.

| (5) | Changes to the Schedules of the Convention on Narcotic Drugs and to the Convention on Psychotropic Substances have direct repercussions for the scope of application of Union law in the area of drug control. Council Framework Decision 2004/757/JHA (1) applies to substances listed in the Schedules of those Conventions. Thus, any change to the Schedules annexed to those Conventions is directly incorporated into common Union rules. |
| --- | --- |

(5)

Changes to the Schedules of the Convention on Narcotic Drugs and to the Convention on Psychotropic Substances have direct repercussions for the scope of application of Union law in the area of drug control. Council Framework Decision 2004/757/JHA (1) applies to substances listed in the Schedules of those Conventions. Thus, any change to the Schedules annexed to those Conventions is directly incorporated into common Union rules.

| (6) | During its 66th session, which is scheduled for 13 to 17 March 2023 in Vienna, the Commission on Narcotic Drugs is to decide on the addition of seven new substances to the Schedules of the Convention on Narcotic Drugs and of the Convention on Psychotropic Substances. |
| --- | --- |

(6)

During its 66th session, which is scheduled for 13 to 17 March 2023 in Vienna, the Commission on Narcotic Drugs is to decide on the addition of seven new substances to the Schedules of the Convention on Narcotic Drugs and of the Convention on Psychotropic Substances.

| (7) | The Union is not a party to the Convention on Narcotic Drugs or to the Convention on Psychotropic Substances. It has an observer status with no voting rights in the Commission on Narcotic Drugs, of which 12 Member States are members with the right to vote in March 2023 (2). It is necessary for the Council to authorise those Member States to express the position of the Union on the scheduling of substances under those Conventions as such decisions fall under the competence of the Union. |
| --- | --- |

(7)

The Union is not a party to the Convention on Narcotic Drugs or to the Convention on Psychotropic Substances. It has an observer status with no voting rights in the Commission on Narcotic Drugs, of which 12 Member States are members with the right to vote in March 2023 (2). It is necessary for the Council to authorise those Member States to express the position of the Union on the scheduling of substances under those Conventions as such decisions fall under the competence of the Union.

| (8) | The WHO has recommended the addition of four new substances to Schedule I of the Convention on Narcotic Drugs, and the addition of three new substances to Schedule II of the Convention on Psychotropic Substances. |
| --- | --- |

(8)

The WHO has recommended the addition of four new substances to Schedule I of the Convention on Narcotic Drugs, and the addition of three new substances to Schedule II of the Convention on Psychotropic Substances.

| (9) | All substances reviewed by the WHO Expert Committee on Drug Dependence (‘the Expert Committee’) and recommended for scheduling by the WHO are monitored by the European Monitoring Centre for Drugs and Drug Addiction (‘EMCDDA’) as new psychoactive substances under the terms of Regulation (EC) No 1920/2006 of the European Parliament and of the Council (3). |
| --- | --- |

(9)

All substances reviewed by the WHO Expert Committee on Drug Dependence (‘the Expert Committee’) and recommended for scheduling by the WHO are monitored by the European Monitoring Centre for Drugs and Drug Addiction (‘EMCDDA’) as new psychoactive substances under the terms of Regulation (EC) No 1920/2006 of the European Parliament and of the Council (3).

| (10) | According to the assessment by the Expert Committee, ADB-BUTINACA (IUPAC name: N-[1-(aminocarbonyl)-2,2-dimethylpropyl]-1-butyl-1H-indazole-3-carboxamide) is an indazole-derived synthetic cannabinoid, the S-enantiomer being the active compound (CAS No.: 2682867-55-4). ADB-BUTINACA has no therapeutic uses and it has not received a medicinal product marketing authorisation. There is sufficient evidence that ADB-BUTINACA is being or is likely to be abused and that it may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that ADB-BUTINACA is placed in Schedule II of the Convention on Psychotropic Substances. |
| --- | --- |

(10)

According to the assessment by the Expert Committee, ADB-BUTINACA (IUPAC name: N-[1-(aminocarbonyl)-2,2-dimethylpropyl]-1-butyl-1H-indazole-3-carboxamide) is an indazole-derived synthetic cannabinoid, the S-enantiomer being the active compound (CAS No.: 2682867-55-4). ADB-BUTINACA has no therapeutic uses and it has not received a medicinal product marketing authorisation. There is sufficient evidence that ADB-BUTINACA is being or is likely to be abused and that it may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that ADB-BUTINACA is placed in Schedule II of the Convention on Psychotropic Substances.

| (11) | ADB-BUTINACA has been detected in 26 Member States and is controlled in at least five Member States. ADB-BUTINACA is subject to intensive monitoring by the EMCDDA. It has been the subject of a public-health alert issued by the Early Warning and Response System of the European Union (‘EWRS’). ADB-BUTINACA is also mentioned in two additional public health-related alerts. It has been associated with serious adverse events, including 14 deaths reported by two Member States. |
| --- | --- |

(11)

ADB-BUTINACA has been detected in 26 Member States and is controlled in at least five Member States. ADB-BUTINACA is subject to intensive monitoring by the EMCDDA. It has been the subject of a public-health alert issued by the Early Warning and Response System of the European Union (‘EWRS’). ADB-BUTINACA is also mentioned in two additional public health-related alerts. It has been associated with serious adverse events, including 14 deaths reported by two Member States.

| (12) | Therefore, the position of the Union should be to add ADB-BUTINACA to Schedule II of the Convention on Psychotropic Substances. |
| --- | --- |

(12)

Therefore, the position of the Union should be to add ADB-BUTINACA to Schedule II of the Convention on Psychotropic Substances.

| (13) | According to the assessment of the Expert Committee, protonitazene (IUPAC name: N,N-diethyl-5-nitro-2-[(4-propoxyphenyl)methyl]-1-H-benzimidazole-1-ethanamine) is a benzimidazole opioid. Protonitazene was first synthetized as an alternative to morphine but there is no approved therapeutic use of protonitazene. There is sufficient evidence that protonitazene is being or is likely to be abused and that it may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that protonitazene be placed in Schedule I of the Convention on Narcotic Drugs. |
| --- | --- |

(13)

According to the assessment of the Expert Committee, protonitazene (IUPAC name: N,N-diethyl-5-nitro-2-[(4-propoxyphenyl)methyl]-1-H-benzimidazole-1-ethanamine) is a benzimidazole opioid. Protonitazene was first synthetized as an alternative to morphine but there is no approved therapeutic use of protonitazene. There is sufficient evidence that protonitazene is being or is likely to be abused and that it may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that protonitazene be placed in Schedule I of the Convention on Narcotic Drugs.

| (14) | Protonitazene has been detected in two Member States and is controlled in at least three Member States. Protonitazene is subject to intensive monitoring by the EMCDDA. No information on serious adverse events involving protonitazene has been reported to the EMCDDA. |
| --- | --- |

(14)

Protonitazene has been detected in two Member States and is controlled in at least three Member States. Protonitazene is subject to intensive monitoring by the EMCDDA. No information on serious adverse events involving protonitazene has been reported to the EMCDDA.

| (15) | Therefore, the position of the Union should be to add protonitazene to the Schedule I of the Convention on Narcotic Drugs. |
| --- | --- |

(15)

Therefore, the position of the Union should be to add protonitazene to the Schedule I of the Convention on Narcotic Drugs.

| (16) | According to the assessment of the Expert Committee, etazene (IUPAC name: 2-[(4-ethoxyphenyl)methyl]-N,N-diethyl-1H-benzimidazole-1-ethanamine) is a benzimidazole-derived synthetic opioid with a chemical structure and pharmacological similar to drugs scheduled under Schedule I (under the Convention on Narcotic Drugs) such as clonitazene, etonitazene and isotonitazene. Etazene was studied for its analgesic properties but there is no known medical use of etazene. There is sufficient evidence that etazene is being or is likely to be abused and that it may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that etazene be placed in Schedule I of the Convention on Narcotic Drugs. |
| --- | --- |

(16)

According to the assessment of the Expert Committee, etazene (IUPAC name: 2-[(4-ethoxyphenyl)methyl]-N,N-diethyl-1H-benzimidazole-1-ethanamine) is a benzimidazole-derived synthetic opioid with a chemical structure and pharmacological similar to drugs scheduled under Schedule I (under the Convention on Narcotic Drugs) such as clonitazene, etonitazene and isotonitazene. Etazene was studied for its analgesic properties but there is no known medical use of etazene. There is sufficient evidence that etazene is being or is likely to be abused and that it may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that etazene be placed in Schedule I of the Convention on Narcotic Drugs.

| (17) | Etazene has been detected in eight Member States and is controlled in at least five Member States. Etazene is subject to intensive monitoring by the EMCDDA. It has been associated with serious adverse events, including four deaths, reported by two Member States. |
| --- | --- |

(17)

Etazene has been detected in eight Member States and is controlled in at least five Member States. Etazene is subject to intensive monitoring by the EMCDDA. It has been associated with serious adverse events, including four deaths, reported by two Member States.

| (18) | Therefore, the position of the Union should be to add etazene to the Schedule I of the Convention on Narcotic Drugs. |
| --- | --- |

(18)

Therefore, the position of the Union should be to add etazene to the Schedule I of the Convention on Narcotic Drugs.

| (19) | According to the assessment of the Expert Committee, etonitazepyne (IUPAC name: 2-[(4-ethoxyphenyl)methyl]-5-nitro-1-(2-pyrrolidin-1-ylethyl)-1H-benzoimidazole) is a benzimidazole-derived synthetic opioid with a chemical structure and pharmacological similar to drugs scheduled under Schedule I (under the Convention on Narcotic Drugs) such as etonitazene. Etonitazepyne was studied for its analgesic properties but there is no known medical use of etonitazepyne. There is sufficient evidence that etonitazepyne is being or is likely to be abused and that it may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that etonitazepyne be placed in Schedule I of the Convention on Narcotic Drugs. |
| --- | --- |

(19)

According to the assessment of the Expert Committee, etonitazepyne (IUPAC name: 2-[(4-ethoxyphenyl)methyl]-5-nitro-1-(2-pyrrolidin-1-ylethyl)-1H-benzoimidazole) is a benzimidazole-derived synthetic opioid with a chemical structure and pharmacological similar to drugs scheduled under Schedule I (under the Convention on Narcotic Drugs) such as etonitazene. Etonitazepyne was studied for its analgesic properties but there is no known medical use of etonitazepyne. There is sufficient evidence that etonitazepyne is being or is likely to be abused and that it may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that etonitazepyne be placed in Schedule I of the Convention on Narcotic Drugs.

| (20) | Etonitazepyne has been detected in six Member States and is controlled in at least two Member States. Similar to other new opioids, etonitazepyne may be sold as a replacement to controlled opioids, and has been the subject of a public health-related alert issued by the EWRS. Etonitazepyne is subject to intensive monitoring by the EMCDDA. A death with confirmed exposure to etonitazepyne has been reported by one country. |
| --- | --- |

(20)

Etonitazepyne has been detected in six Member States and is controlled in at least two Member States. Similar to other new opioids, etonitazepyne may be sold as a replacement to controlled opioids, and has been the subject of a public health-related alert issued by the EWRS. Etonitazepyne is subject to intensive monitoring by the EMCDDA. A death with confirmed exposure to etonitazepyne has been reported by one country.

| (21) | Therefore, the position of the Union should be to add etonitazepyne to the Schedule I of the Convention on Narcotic Drugs. |
| --- | --- |

(21)

Therefore, the position of the Union should be to add etonitazepyne to the Schedule I of the Convention on Narcotic Drugs.

| (22) | According to the assessment of the Expert Committee, 2-methyl-AP-237 (IUPAC name: 1-{2-methyl-4-[(2E)-3-phenylprop-2-en-1-yl]piperazin-1-yl}butan-1-one) is a synthetic opioid typically classed as a 1-cinnamylpiperazine. There is no known therapeutic use for 2-methyl-AP-237, nor has it received a medicinal product marketing authorisation. There is sufficient evidence that 2-methyl-AP-237 is being or is likely to be abused and that it may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that 2-methyl-AP-237 be placed in Schedule I of the Convention on Narcotic Drugs. |
| --- | --- |

(22)

According to the assessment of the Expert Committee, 2-methyl-AP-237 (IUPAC name: 1-{2-methyl-4-[(2E)-3-phenylprop-2-en-1-yl]piperazin-1-yl}butan-1-one) is a synthetic opioid typically classed as a 1-cinnamylpiperazine. There is no known therapeutic use for 2-methyl-AP-237, nor has it received a medicinal product marketing authorisation. There is sufficient evidence that 2-methyl-AP-237 is being or is likely to be abused and that it may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that 2-methyl-AP-237 be placed in Schedule I of the Convention on Narcotic Drugs.

| (23) | 2-Methyl-AP-237 has been detected in six Member States and is controlled in at least four Member States. It has been associated with serious adverse events, including a death. |
| --- | --- |

(23)

2-Methyl-AP-237 has been detected in six Member States and is controlled in at least four Member States. It has been associated with serious adverse events, including a death.

| (24) | Therefore, the position of the Union should be to add 2-methyl-AP-237 to the Schedule I of the Convention on Narcotic Drugs. |
| --- | --- |

(24)

Therefore, the position of the Union should be to add 2-methyl-AP-237 to the Schedule I of the Convention on Narcotic Drugs.

| (25) | According to the assessment of the Expert Committee, alpha-PiHP (α-PiHP, IUPAC name: 4-methyl-1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one) is a synthetic cathinone. There is no known therapeutic use for alpha-PiHP, nor has it received a medicinal product marketing authorisation. There is sufficient evidence that alpha-PiHP is being or is likely to be abused and that it may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that alpha-PiHP be placed in Schedule II of the Convention on Psychotropic Substances. |
| --- | --- |

(25)

According to the assessment of the Expert Committee, alpha-PiHP (α-PiHP, IUPAC name: 4-methyl-1-phenyl-2-(pyrrolidin-1-yl)pentan-1-one) is a synthetic cathinone. There is no known therapeutic use for alpha-PiHP, nor has it received a medicinal product marketing authorisation. There is sufficient evidence that alpha-PiHP is being or is likely to be abused and that it may constitute a public health and social problem warranting the placing of the substance under international control. Thus, the WHO recommends that alpha-PiHP be placed in Schedule II of the Convention on Psychotropic Substances.

| (26) | Alpha-PiHP has been detected in 18 Member States and is controlled in at least seven Member States. Alpha-PiHP is mentioned in a public health-related alert issued by the EWRS. It has been associated with serious adverse events, including four deaths, reported by one Member State and detected in biological samples linked to serious adverse events, reported by four Member States. |
| --- | --- |

(26)

Alpha-PiHP has been detected in 18 Member States and is controlled in at least seven Member States. Alpha-PiHP is mentioned in a public health-related alert issued by the EWRS. It has been associated with serious adverse events, including four deaths, reported by one Member State and detected in biological samples linked to serious adverse events, reported by four Member States.

| (27) | Therefore, the position of the Union should be to add alpha-PiHP to the Schedule II of the Convention on Psychotropic Substances. |
| --- | --- |

(27)

Therefore, the position of the Union should be to add alpha-PiHP to the Schedule II of the Convention on Psychotropic Substances.

| (28) | According to the assessment of the Expert Committee, 3-methylmethcathinone (3-MMC, IUPAC name: 2-(methylamino)-1-(3-methylphenyl)propan-1-one) is a synthetic cathinone and a positional isomer of the internationally controlled 4-methylmethcathinone (4-MMC, mephedrone, Schedule II of the Convention on Psychotropic Substances). 3-MMC was critically reviewed in 2016, but it was decided to request another critical review, to be considered at a subsequent meeting, pending the availability of more information. Some patent applications including the use of 3-MMC were found but no current clinical trials were identified on therapeutic use of 3-MMC. 3-MMC also has no recognised human or veterinary medical use in the Union. |
| --- | --- |

(28)

According to the assessment of the Expert Committee, 3-methylmethcathinone (3-MMC, IUPAC name: 2-(methylamino)-1-(3-methylphenyl)propan-1-one) is a synthetic cathinone and a positional isomer of the internationally controlled 4-methylmethcathinone (4-MMC, mephedrone, Schedule II of the Convention on Psychotropic Substances). 3-MMC was critically reviewed in 2016, but it was decided to request another critical review, to be considered at a subsequent meeting, pending the availability of more information. Some patent applications including the use of 3-MMC were found but no current clinical trials were identified on therapeutic use of 3-MMC. 3-MMC also has no recognised human or veterinary medical use in the Union.

| (29) | The risks of 3-MMC have been assessed by the scientific committee of the EMCDDA and 3-MMC has already been included in the definition of ‘drug’ under Framework Decision 2004/757/JHA by Commission Delegated Directive (EU) 2022/1326 (4). 3-MMC is subject to intensive monitoring by the EMCDDA. At the time of risk assessment, in November 2021, 3-MMC had been detected in 23 Member States. A total of 27 deaths with confirmed exposure to 3-MMC had been reported by five Member States and 14 acute non-fatal poisonings with confirmed exposure to 3-MMC had been reported by four Member States. |
| --- | --- |

(29)

The risks of 3-MMC have been assessed by the scientific committee of the EMCDDA and 3-MMC has already been included in the definition of ‘drug’ under Framework Decision 2004/757/JHA by Commission Delegated Directive (EU) 2022/1326 (4). 3-MMC is subject to intensive monitoring by the EMCDDA. At the time of risk assessment, in November 2021, 3-MMC had been detected in 23 Member States. A total of 27 deaths with confirmed exposure to 3-MMC had been reported by five Member States and 14 acute non-fatal poisonings with confirmed exposure to 3-MMC had been reported by four Member States.

| (30) | Therefore, the position of the Union should be to add 3-MMC to the Schedule II of the Convention on Psychotropic Substances. |
| --- | --- |

(30)

Therefore, the position of the Union should be to add 3-MMC to the Schedule II of the Convention on Psychotropic Substances.

| (31) | It is appropriate to establish the position to be taken on behalf of the Union in the Commission on Narcotic Drugs, as the decisions on scheduling as regards the seven substances will directly influence the content of Union law, namely Framework Decision 2004/757/JHA. |
| --- | --- |

(31)

It is appropriate to establish the position to be taken on behalf of the Union in the Commission on Narcotic Drugs, as the decisions on scheduling as regards the seven substances will directly influence the content of Union law, namely Framework Decision 2004/757/JHA.

| (32) | The position of the Union is to be expressed by the Member States that are members of the Commission on Narcotic Drugs, acting jointly. |
| --- | --- |

(32)

The position of the Union is to be expressed by the Member States that are members of the Commission on Narcotic Drugs, acting jointly.

| (33) | Denmark is bound by Framework Decision 2004/757/JHA and is therefore taking part in the adoption and application of this Decision. |
| --- | --- |

(33)

Denmark is bound by Framework Decision 2004/757/JHA and is therefore taking part in the adoption and application of this Decision.

| (34) | Ireland is bound by Framework Decision 2004/757/JHA and is therefore taking part in the adoption and application of this Decision, |
| --- | --- |

(34)

Ireland is bound by Framework Decision 2004/757/JHA and is therefore taking part in the adoption and application of this Decision,

HAS ADOPTED THIS DECISION:

Article 1

The position to be taken on behalf of the Union by the Member States in the 66th session of the Commission on Narcotic Drugs, which takes place from 13 to 17 March 2023, when that body is called upon to adopt decisions on the addition of substances to the Schedules of the United Nations Single Convention on Narcotic Drugs of 1961, as amended by the 1972 Protocol, and the United Nations Convention on Psychotropic Substances of 1971, shall be that set out in the Annex to this Decision.

Article 2

The position referred to in Article 1 shall be expressed by the Member States that are members of the Commission of Narcotic Drugs, acting jointly in the interest of the Union.

Article 3

This Decision is addressed to the Member States in accordance with the Treaties.

Done at Brussels, 9 March 2023.

For the Council

The President

G. STRÖMMER

---

(1)  Council Framework Decision 2004/757/JHA of 25 October 2004 laying down minimum provisions on the constituent elements of criminal acts and penalties in the field of illicit drug trafficking (OJ L 335, 11.11.2004, p. 8).

1

(2)  Austria, Belgium, France, Germany, Hungary, Italy, Lithuania, Netherlands, Poland, Slovenia, Spain, and Sweden.

2

(3)  Regulation (EC) No 1920/2006 of the European Parliament and of the Council of 12 December 2006 on the European Monitoring Centre for Drugs and Drug Addiction (OJ L 376, 27.12.2006, p. 1).

3

(4)  Commission Delegated Directive (EU) 2022/1326 of 18 March 2022 amending the Annex to Council Framework Decision 2004/757/JHA as regards the inclusion of new psychoactive substances in the definition of ‘drug’ (OJ L 200, 29.7.2022, p. 148).

4

---

ANNEX

Position to be taken by the Member States which are members of the Commission on Narcotic Drugs, acting jointly in the interest of the Union during the 66th session of the Commission on Narcotic Drugs, which takes place from 13 to 17 March 2023, on the scheduling of substances:

| (1) | ADB-BUTINACA is to be included in Schedule II of the Convention on Psychotropic Substances. |
| --- | --- |

(1)

ADB-BUTINACA is to be included in Schedule II of the Convention on Psychotropic Substances.

| (2) | Protonitazene is to be included in Schedule I of the Convention on Narcotic Drugs. |
| --- | --- |

(2)

Protonitazene is to be included in Schedule I of the Convention on Narcotic Drugs.

| (3) | Etazene is to be included in Schedule I of the Convention on Narcotic Drugs. |
| --- | --- |

(3)

Etazene is to be included in Schedule I of the Convention on Narcotic Drugs.

| (4) | Etonitazepyne is to be included in Schedule I of the Convention on Narcotic Drugs. |
| --- | --- |

(4)

Etonitazepyne is to be included in Schedule I of the Convention on Narcotic Drugs.

| (5) | 2-methyl-AP-237 is to be included in Schedule I of the Convention on Narcotic Drugs. |
| --- | --- |

(5)

2-methyl-AP-237 is to be included in Schedule I of the Convention on Narcotic Drugs.

| (6) | Alpha-PiHP is to be included in the Schedule II of the Convention on Psychotropic Substances. |
| --- | --- |

(6)

Alpha-PiHP is to be included in the Schedule II of the Convention on Psychotropic Substances.

| (7) | 3-MMC is to be included in the Schedule II of the Convention on Psychotropic Substances. |
| --- | --- |

(7)

3-MMC is to be included in the Schedule II of the Convention on Psychotropic Substances.

---

| 13.3.2023 | EN | Official Journal of the European Union | L 74/58 |
| --- | --- | --- | --- |

13.3.2023

EN

Official Journal of the European Union

L 74/58

---

COUNCIL DECISION (EU) 2023/568

of 9 March 2023

on the position to be taken on behalf of the Union in the 228th session of the Council of the International Civil Aviation Organization (ICAO) as regards the adoption of Amendment 93 to Annex 10 – Aeronautical Telecommunications, Volume I – Radio Navigation Aids of the Convention on International Civil Aviation and of the amendment to the Technical instructions for the safe transport of dangerous goods by air to permit active tracking devices powered by small lithium batteries in checked baggage

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 100(2), in conjunction with Article 218(9) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | The Convention on International Civil Aviation (‘the Chicago Convention’), which regulates international air transport, entered into force on 4 April 1947. It established the International Civil Aviation Organization (ICAO). |
| --- | --- |

(1)

The Convention on International Civil Aviation (‘the Chicago Convention’), which regulates international air transport, entered into force on 4 April 1947. It established the International Civil Aviation Organization (ICAO).

| (2) | The Member States of the Union are Contracting States to the Chicago Convention and members of the ICAO, while the Union has observer status in certain ICAO bodies. Six Member States are currently represented in the ICAO Council. |
| --- | --- |

(2)

The Member States of the Union are Contracting States to the Chicago Convention and members of the ICAO, while the Union has observer status in certain ICAO bodies. Six Member States are currently represented in the ICAO Council.

| (3) | Pursuant to Article 54 of the Chicago Convention, the ICAO Council may adopt international standards and recommended practices (‘SARPs’), and designate them as Annexes to the Chicago Convention. |
| --- | --- |

(3)

Pursuant to Article 54 of the Chicago Convention, the ICAO Council may adopt international standards and recommended practices (‘SARPs’), and designate them as Annexes to the Chicago Convention.

| (4) | The ICAO Council, at its 228th session, is to adopt Amendment 93 to Annex 10, Volume I to the Chicago Convention. |
| --- | --- |

(4)

The ICAO Council, at its 228th session, is to adopt Amendment 93 to Annex 10, Volume I to the Chicago Convention.

| (5) | The main purpose of Amendment 93 to Annex 10, Volume I to the Chicago Convention is to support the introduction of dual-frequency, multi-constellation (DFMC) global navigation satellite system (GNSS) by adding provisions for additional frequencies of operation for the global positioning system (GPS), the global navigation satellite system (GLONASS) and the satellite-based augmentation system (SBAS), and by introducing provisions for the new BeiDou Navigation Satellite System (BDS) and the Galileo system. It is also to support ionospheric gradient mitigation for the ground-based augmentation system (GBAS). |
| --- | --- |

(5)

The main purpose of Amendment 93 to Annex 10, Volume I to the Chicago Convention is to support the introduction of dual-frequency, multi-constellation (DFMC) global navigation satellite system (GNSS) by adding provisions for additional frequencies of operation for the global positioning system (GPS), the global navigation satellite system (GLONASS) and the satellite-based augmentation system (SBAS), and by introducing provisions for the new BeiDou Navigation Satellite System (BDS) and the Galileo system. It is also to support ionospheric gradient mitigation for the ground-based augmentation system (GBAS).

| (6) | It is appropriate to establish the position to be taken on behalf of the Union within the ICAO Council, as Amendment 93 to Annex 10, Volume I to the Chicago Convention will be binding under international law and is capable of decisively influencing the content of Union law, namely Commission Implementing Regulation (EU) 2017/373 (1). |
| --- | --- |

(6)

It is appropriate to establish the position to be taken on behalf of the Union within the ICAO Council, as Amendment 93 to Annex 10, Volume I to the Chicago Convention will be binding under international law and is capable of decisively influencing the content of Union law, namely Commission Implementing Regulation (EU) 2017/373 (1).

| (7) | The position to be taken on behalf of the Union in the 228th session of the ICAO Council or any subsequent session with regard to the adoption of Amendment 93 to Annex 10, Volume I to the Chicago Convention as outlined in State Letter 2021/41 should be to support and to fully comply with this amendment. This position should be expressed by the Member States of the Union that are members of the ICAO Council, acting jointly in the interest of the Union. |
| --- | --- |

(7)

The position to be taken on behalf of the Union in the 228th session of the ICAO Council or any subsequent session with regard to the adoption of Amendment 93 to Annex 10, Volume I to the Chicago Convention as outlined in State Letter 2021/41 should be to support and to fully comply with this amendment. This position should be expressed by the Member States of the Union that are members of the ICAO Council, acting jointly in the interest of the Union.

| (8) | Once adopted and effective, Amendment 93 to Annex 10, Volume I to the Chicago Convention will be binding on all ICAO Member States, including all Member States of the Union, in accordance with and within the limits set out in the Chicago Convention. |
| --- | --- |

(8)

Once adopted and effective, Amendment 93 to Annex 10, Volume I to the Chicago Convention will be binding on all ICAO Member States, including all Member States of the Union, in accordance with and within the limits set out in the Chicago Convention.

| (9) | Pursuant to Article 38 of the Chicago Convention, any State which finds it impracticable to comply in all respects with any international standard or procedure adopted by ICAO, or to bring its own regulations or practices into full accord with any such international standard or procedure or which deems it necessary to adopt regulations or practices differing in any particular respect from those established by an international standard, should give immediate notification to the ICAO of the differences between its own practice and that established by the international standard. |
| --- | --- |

(9)

Pursuant to Article 38 of the Chicago Convention, any State which finds it impracticable to comply in all respects with any international standard or procedure adopted by ICAO, or to bring its own regulations or practices into full accord with any such international standard or procedure or which deems it necessary to adopt regulations or practices differing in any particular respect from those established by an international standard, should give immediate notification to the ICAO of the differences between its own practice and that established by the international standard.

| (10) | Pursuant to Article 90 of the Chicago Convention, any Annex or any amendment of an Annex adopted by the ICAO Council becomes effective within three months after its submission to the ICAO Contracting States, or at the end of such longer period of time as the ICAO Council may prescribe, unless in the meantime a majority of ICAO Contracting States register their disapproval with the ICAO Council. |
| --- | --- |

(10)

Pursuant to Article 90 of the Chicago Convention, any Annex or any amendment of an Annex adopted by the ICAO Council becomes effective within three months after its submission to the ICAO Contracting States, or at the end of such longer period of time as the ICAO Council may prescribe, unless in the meantime a majority of ICAO Contracting States register their disapproval with the ICAO Council.

| (11) | The position to be taken on behalf of the Union after the adoption of Amendment 93 to Annex 10, Volume I to the Chicago Convention by the ICAO Council, to be announced by the ICAO Secretary-General by means of an ICAO State-letter procedure, should be not to register disapproval and to notify compliance, provided that that amendment is adopted without any substantial changes. Where Union law would deviate from the newly adopted SARPs after an envisaged date of application of those SARPs, any difference with those particular SARPs should be notified to the ICAO. The position to be taken on behalf of the Union with respect to such a difference should be based on a written document submitted by the Commission to the Council for discussion and approval. This position should be expressed by all the Member States of the Union, acting jointly in the interest of the Union. |
| --- | --- |

(11)

The position to be taken on behalf of the Union after the adoption of Amendment 93 to Annex 10, Volume I to the Chicago Convention by the ICAO Council, to be announced by the ICAO Secretary-General by means of an ICAO State-letter procedure, should be not to register disapproval and to notify compliance, provided that that amendment is adopted without any substantial changes. Where Union law would deviate from the newly adopted SARPs after an envisaged date of application of those SARPs, any difference with those particular SARPs should be notified to the ICAO. The position to be taken on behalf of the Union with respect to such a difference should be based on a written document submitted by the Commission to the Council for discussion and approval. This position should be expressed by all the Member States of the Union, acting jointly in the interest of the Union.

| (12) | The ICAO Council, at its 228th session, is also to adopt an Amendment to the Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Doc 9284) to permit active tracking devices powered by small lithium batteries in checked baggage. The matter falls under Annex 18 to the Chicago Convention – The Safe Transport of Dangerous Goods by Air. |
| --- | --- |

(12)

The ICAO Council, at its 228th session, is also to adopt an Amendment to the Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Doc 9284) to permit active tracking devices powered by small lithium batteries in checked baggage. The matter falls under Annex 18 to the Chicago Convention – The Safe Transport of Dangerous Goods by Air.

| (13) | The amendment would allow passengers and crew to carry active tracking devices powered by small lithium batteries in their checked baggage, which ICAO Doc 9284 prohibits because of a requirement to have devices containing lithium cells or batteries in checked baggage switched off. |
| --- | --- |

(13)

The amendment would allow passengers and crew to carry active tracking devices powered by small lithium batteries in their checked baggage, which ICAO Doc 9284 prohibits because of a requirement to have devices containing lithium cells or batteries in checked baggage switched off.

| (14) | It is appropriate to establish the position to be taken on behalf of the Union within the ICAO Council as the proposed changes to ICAO Doc 9284 would have a direct impact on the rules for the transport of dangerous goods in Commission Regulation (EU) No 965/2012 (2), which refer expressly to that ICAO document, and are therefore capable of decisively influencing the content of Union law. |
| --- | --- |

(14)

It is appropriate to establish the position to be taken on behalf of the Union within the ICAO Council as the proposed changes to ICAO Doc 9284 would have a direct impact on the rules for the transport of dangerous goods in Commission Regulation (EU) No 965/2012 (2), which refer expressly to that ICAO document, and are therefore capable of decisively influencing the content of Union law.

| (15) | The position to be taken on behalf of the Union during the 228th session of the ICAO Council or any subsequent session with regards to the adoption of the Amendment to ICAO Doc 9284 should be to support this amendment. This position should be expressed by the Member States of the Union that are members of the ICAO Council, acting jointly in the interest of the Union, |
| --- | --- |

(15)

The position to be taken on behalf of the Union during the 228th session of the ICAO Council or any subsequent session with regards to the adoption of the Amendment to ICAO Doc 9284 should be to support this amendment. This position should be expressed by the Member States of the Union that are members of the ICAO Council, acting jointly in the interest of the Union,

HAS ADOPTED THIS DECISION:

Article 1

1.   The position to be taken on behalf of the Union in the 228th session of the ICAO Council, or in any subsequent sessions, shall be to support Amendment 93 to Annex 10, Volume I to the Chicago Convention.

2.   The position to be taken on behalf of the Union, provided the ICAO Council adopts Amendment 93 to Annex 10, Volume I to the Chicago Convention without any substantial changes, shall be not to register disapproval and to notify compliance with that amendment in response to the respective ICAO State-letter.

3.   Where Union law would deviate from the newly adopted SARPs after the envisaged date of application of those SARPs, a difference with those particular SARPs shall be notified to ICAO, in accordance with Article 38 of the Chicago Convention. In such a case, the Commission shall, in due time and at least two months before any deadline set by the ICAO for the notification of differences, submit to the Council, for discussion and approval, a preparatory document setting out the position to be taken on behalf of the Union on the detailed differences to be notified to the ICAO.

Article 2

The position to be taken on behalf of the Union in the 228th session of the ICAO Council, or in any subsequent sessions, shall be to support the Amendment to the Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Doc 9284).

Article 3

The position referred to in Article 1(1) and in Article 2 shall be expressed by the Member States of the Union that are members of the ICAO Council, acting jointly in the interest of the Union.

The position referred to in Article 1(2) and (3) shall be expressed by all the Member States of the Union, acting jointly in the interest of the Union.

Article 4

This Decision shall enter into force on the date of its adoption.

Done at Brussels, 9 March 2023.

For the Council

The President

G. STRÖMMER

---

(1)  Commission Implementing Regulation (EU) 2017/373 of 1 March 2017 laying down common requirements for providers of air traffic management/air navigation services and other air traffic management network functions and their oversight, repealing Regulation (EC) No 482/2008, Implementing Regulations (EU) No 1034/2011, (EU) No 1035/2011 and (EU) 2016/1377 and amending Regulation (EU) No 677/2011 (OJ L 62, 8.3.2017, p. 1).

1

(2)  Commission Regulation (EU) No 965/2012 of 5 October 2012 laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 296, 25.10.2012, p. 1).

2

---

| 13.3.2023 | EN | Official Journal of the European Union | L 74/61 |
| --- | --- | --- | --- |

13.3.2023

EN

Official Journal of the European Union

L 74/61

---

COUNCIL DECISION (EU) 2023/569

of 9 March 2023

on the position to be taken on behalf of the European Union at the Council of the International Civil Aviation Organization, in respect of proposals for the amendment of Annex 16, Volumes I to III to the Chicago Convention, concerning Standards and Recommended Practices relating to environmental protection

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 100(2), in conjunction with Article 218(9) thereof,

Having regard to the proposal from the European Commission,

Whereas:

| (1) | The Convention on International Civil Aviation (‘the Chicago Convention’), which regulates international air transport, entered into force on 4 April 1947. It established the International Civil Aviation Organization (ICAO). |
| --- | --- |

(1)

The Convention on International Civil Aviation (‘the Chicago Convention’), which regulates international air transport, entered into force on 4 April 1947. It established the International Civil Aviation Organization (ICAO).

| (2) | All Member States are Contracting States of the Chicago Convention and members of the ICAO, whereas the Union has observer status in certain ICAO bodies. |
| --- | --- |

(2)

All Member States are Contracting States of the Chicago Convention and members of the ICAO, whereas the Union has observer status in certain ICAO bodies.

| (3) | Pursuant to Article 54 of the Chicago Convention, the ICAO Council may adopt International Standards and Recommended Practices (SARPs). |
| --- | --- |

(3)

Pursuant to Article 54 of the Chicago Convention, the ICAO Council may adopt International Standards and Recommended Practices (SARPs).

| (4) | The SARPs on Environmental Protection have been adopted as Annex 16 to the Chicago Convention by the ICAO Council, in Volumes I to IV. |
| --- | --- |

(4)

The SARPs on Environmental Protection have been adopted as Annex 16 to the Chicago Convention by the ICAO Council, in Volumes I to IV.

| (5) | The ICAO Council, during its 228th Session to be held on 13 to 31 March 2023, is to adopt a number of amendments to Annex 16, Volumes I to III of the Chicago Convention. |
| --- | --- |

(5)

The ICAO Council, during its 228th Session to be held on 13 to 31 March 2023, is to adopt a number of amendments to Annex 16, Volumes I to III of the Chicago Convention.

| (6) | It is appropriate to establish the position to be taken on behalf of the Union in the ICAO Council as the proposed amendments have legal effect, given that they are binding under international law and are capable of decisively influencing the content of Union law, namely Regulation (EU) 2018/1139 of the European Parliament and of the Council (1) and Commission Regulation (EU) No 748/2012 (2). |
| --- | --- |

(6)

It is appropriate to establish the position to be taken on behalf of the Union in the ICAO Council as the proposed amendments have legal effect, given that they are binding under international law and are capable of decisively influencing the content of Union law, namely Regulation (EU) 2018/1139 of the European Parliament and of the Council (1) and Commission Regulation (EU) No 748/2012 (2).

| (7) | The position to be taken on behalf of the Union should be to support the amendments to Volumes I to III. |
| --- | --- |

(7)

The position to be taken on behalf of the Union should be to support the amendments to Volumes I to III.

| (8) | The position to be taken on behalf of the Union should be expressed by the Member States of the Union that are members of the ICAO Council, acting jointly in the interest of the Union. |
| --- | --- |

(8)

The position to be taken on behalf of the Union should be expressed by the Member States of the Union that are members of the ICAO Council, acting jointly in the interest of the Union.

| (9) | The position to be taken on behalf of the Union after the adoption of amendments to Annex 16, Volumes I to III to the Chicago Convention by the ICAO Council, to be announced by the ICAO Secretary-General via an ICAO State Letter procedure, should be not to register disapproval and should be to notify compliance with those measures. Where Union law would deviate from the newly adopted SARPs after an envisaged date of application of those SARPs, any difference with those particular SARPs should be notified to ICAO, |
| --- | --- |

(9)

The position to be taken on behalf of the Union after the adoption of amendments to Annex 16, Volumes I to III to the Chicago Convention by the ICAO Council, to be announced by the ICAO Secretary-General via an ICAO State Letter procedure, should be not to register disapproval and should be to notify compliance with those measures. Where Union law would deviate from the newly adopted SARPs after an envisaged date of application of those SARPs, any difference with those particular SARPs should be notified to ICAO,

HAS ADOPTED THIS DECISION:

Article 1

1.   The position to be taken on behalf of the Union in the 228th Session of the ICAO Council, or in any of its subsequent sessions, in respect of proposals for the amendment of Annex 16, Volumes I to III to the the Chicago Convention, concerning Standards and Recommended Practices relating to environmental protection shall be to support the proposed amendments in their entirety.

2.   The position to be taken on behalf of the Union, provided the ICAO Council adopts without any substantial change the proposed amendments to Annex 16, Volumes I to III to the Chicago Convention referred to in paragraph 1 of this Article, shall be not to register disapproval and shall be to notify compliance with the adopted measure in reply to the respective ICAO State Letter. Where Union law would deviate from the newly adopted International Standards and Recommended Practices (SARPs) after the envisaged date of application of those SARPs, any difference with those particular SARPs shall be notified to ICAO. In such case, the Commission shall, in due time and at least two months before any deadline set by the ICAO for the notification of differences, submit to the Council, for discussion and approval, a preparatory document setting out the detailed differences to be notified to the ICAO on behalf of the Union by the Member States.

Article 2

The position referred to in Article 1(1) shall be expressed by the Member States of the Union that are members of the ICAO Council, acting jointly in the interest of the Union.

The position referred to in Article 1(2) shall be expressed by all the Member States of the Union, acting jointly in the interest of the Union.

Article 3

This Decision shall enter into force on the date of its adoption.

Done at Brussels, 9 March 2023.

For the Council

The President

G. STRÖMMER

---

(1)  Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1).

1

(2)  Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations (OJ L 224, 21.8.2012, p. 1).

2

---

| 13.3.2023 | EN | Official Journal of the European Union | L 74/63 |
| --- | --- | --- | --- |

13.3.2023

EN

Official Journal of the European Union

L 74/63

---

COMMISSION IMPLEMENTING DECISION (EU) 2023/570

of 10 March 2023

granting derogations to certain Member States from the application of Regulation (EC) No 138/2004 of the European Parliament and of the Council on the economic accounts for agriculture

(notified under document C(2023) 1562)

(Only the Italian, Polish, Slovenian and Spanish texts are authentic)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 138/2004 of the European Parliament and of the Council of 5 December 2003 on the economic accounts for agriculture in the Community (1), and in particular Article 4b(1) thereof,

Whereas:

| (1) | In accordance with Article 4b(2) of Regulation (EC) No 138/2004, the Kingdom of Spain, the Italian Republic, the Republic of Poland and the Republic of Slovenia submitted requests for derogation by 21 August 2022. |
| --- | --- |

(1)

In accordance with Article 4b(2) of Regulation (EC) No 138/2004, the Kingdom of Spain, the Italian Republic, the Republic of Poland and the Republic of Slovenia submitted requests for derogation by 21 August 2022.

| (2) | The information that those Member States provided to the Commission indicates that the requests of the Kingdom of Spain, the Italian Republic, the Republic of Poland and the Republic of Slovenia are justified by the need for major adaptations in their national statistical systems as regards implementation of the transmission programme of data for regional economic accounts for agriculture, as referred to in Annex II to Regulation (EC) No 138/2004. |
| --- | --- |

(2)

The information that those Member States provided to the Commission indicates that the requests of the Kingdom of Spain, the Italian Republic, the Republic of Poland and the Republic of Slovenia are justified by the need for major adaptations in their national statistical systems as regards implementation of the transmission programme of data for regional economic accounts for agriculture, as referred to in Annex II to Regulation (EC) No 138/2004.

| (3) | The requested derogations should therefore be granted to the Kingdom of Spain, the Italian Republic, the Republic of Poland and the Republic of Slovenia. |
| --- | --- |

(3)

The requested derogations should therefore be granted to the Kingdom of Spain, the Italian Republic, the Republic of Poland and the Republic of Slovenia.

| (4) | The measures provided for in this Decision are in accordance with the opinion of the European Statistical System Committee (2), |
| --- | --- |

(4)

The measures provided for in this Decision are in accordance with the opinion of the European Statistical System Committee (2),

HAS ADOPTED THIS DECISION:

Article 1

The derogations from Regulation (EC) No 138/2004 set out in the Annex to this Decision shall be granted to the Member States listed therein.

Article 2

This Decision is addressed to the Kingdom of Spain, the Italian Republic, the Republic of Poland and the Republic of Slovenia.

Done at Brussels, 10 March 2023.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  OJ L 33, 5.2.2004, p. 1.

1

(2)  Regulation (EC) No 223/2009 of the European Parliament and of the Council of 11 March 2009 on European statistics and repealing Regulation (EC, Euratom) No 1101/2008 of the European Parliament and of the Council on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities, Council Regulation (EC) No 322/97 on Community Statistics, and Council Decision 89/382/EEC, Euratom establishing a Committee on the Statistical Programmes of the European Communities (OJ L 87, 31.3.2009, p. 164).

2

---

ANNEX

| Provision concerned | Member State | Derogation period granted | Reference years covered by derogation | Scope of the derogation |
| --- | --- | --- | --- | --- |
| Annex II to Regulation (EC) No 138/2004 | Kingdom of Spain | 2 years (30 Sep. 2023-29 Sep. 2025) | 2021, 2022 | Transmission of 7 variables:






  — | Item 32.1 (GFCF in plantations); |

Provision concerned

Member State

Derogation period granted

Reference years covered by derogation

Scope of the derogation

Annex II to Regulation (EC) No 138/2004

Kingdom of Spain

2 years (30 Sep. 2023-29 Sep. 2025)

2021, 2022

Transmission of 7 variables:

—

Item 32.1 (GFCF in plantations);

| — | Item 32.2 (GFCF in animals); |
| --- | --- |

—

Item 32.2 (GFCF in animals);

| — | Item 33.1 (GFCF in materials); |
| --- | --- |

—

Item 33.1 (GFCF in materials);

| — | Item 33.3 (Other GFCF); |
| --- | --- |

—

Item 33.3 (Other GFCF);

| — | Item 36 (Changes in inventories); |
| --- | --- |

—

Item 36 (Changes in inventories);

| — | Item 37.1 (Investment grants); |
| --- | --- |

—

Item 37.1 (Investment grants);

| — | Item 37.2 (Other capital transfers). |
| --- | --- |

—

Item 37.2 (Other capital transfers).

Annex II to Regulation (EC) No 138/2004

Italian Republic

2 years (30 Sep. 2023-29 Sep. 2025)

2021, 2022

Transmission of variables according to terminology of Annex II to Regulation (EC) No 138/2004 from Item 21 (fixed capital consumption) to Item 37 (capital transfers).

Annex II to Regulation (EC) No 138/2004

Republic of Poland

2 years (30 Sep. 2023-29 Sep. 2025)

2021, 2022

Transmission of all variables that are listed in Annex II to Regulation (EC) No 138/2004 regarding REAA.

Annex II to Regulation (EC) No 138/2004

Republic of Slovenia

2 years (30 Sep. 2023-29 Sep. 2025)

2021, 2022

Transmission of all variables that are listed in Annex II to Regulation (EC) No 138/2004 regarding REAA.

---