# Official Journal L 33/2022

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 33 |
| | |
| English edition | Legislation | Volume 6515 February 2022 |

ISSN 1977-0677

Official Journal

of the European Union

L 33

English edition

Legislation

Volume 6515 February 2022

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) 2022/199 of 2 December 2021 amending Regulation (EU) 2019/1241 of the European Parliament and of the Council as regards the use of excluder devices in the North Sea fishery for Norway pout | 1 |
| | * | Commission Delegated Regulation (EU) 2022/200 of 2 December 2021 amending Regulation (EU) 2019/1241 of the European Parliament and of the Council as regards certain technical measures on mesh sizes and the overall maximum length for certain beam trawls in the North Sea | 4 |
| | * | Commission Delegated Regulation (EU) 2022/201 of 10 December 2021 amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by design and production organisations, as well as procedures applied by the Agency, and correcting that Regulation | 7 |
| | * | Commission Implementing Regulation (EU) 2022/202 of 14 February 2022 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods (
  1
  ) | 41 |
| | * | Commission Implementing Regulation (EU) 2022/203 of 14 February 2022 amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by competent authorities, and correcting Regulation (EU) No 748/2012 as regards the issuance of airworthiness review certificates | 46 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Delegated Regulation (EU) 2022/199 of 2 December 2021 amending Regulation (EU) 2019/1241 of the European Parliament and of the Council as regards the use of excluder devices in the North Sea fishery for Norway pout

1

*

Commission Delegated Regulation (EU) 2022/200 of 2 December 2021 amending Regulation (EU) 2019/1241 of the European Parliament and of the Council as regards certain technical measures on mesh sizes and the overall maximum length for certain beam trawls in the North Sea

4

*

Commission Delegated Regulation (EU) 2022/201 of 10 December 2021 amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by design and production organisations, as well as procedures applied by the Agency, and correcting that Regulation

7

*

Commission Implementing Regulation (EU) 2022/202 of 14 February 2022 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods (
  1
  )

1

41

*

Commission Implementing Regulation (EU) 2022/203 of 14 February 2022 amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by competent authorities, and correcting Regulation (EU) No 748/2012 as regards the issuance of airworthiness review certificates

46

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

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(1)   Text with EEA relevance.

1

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

EN

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

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

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II Non-legislative acts

REGULATIONS

| 15.2.2022 | EN | Official Journal of the European Union | L 33/1 |
| --- | --- | --- | --- |

15.2.2022

EN

Official Journal of the European Union

L 33/1

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COMMISSION DELEGATED REGULATION (EU) 2022/199

of 2 December 2021

amending Regulation (EU) 2019/1241 of the European Parliament and of the Council as regards the use of excluder devices in the North Sea fishery for Norway pout

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2019/1241 of the European Parliament and of the Council of 20 June 2019 on the conservation of fisheries resources and the protection of marine ecosystems through technical measures, amending Council Regulations (EC) No 1967/2006, (EC) No 1224/2009 and Regulations (EU) No 1380/2013, (EU) 2016/1139, (EU) 2018/973, (EU) 2019/472 and (EU) 2019/1022 of the European Parliament and of the Council, and repealing Council Regulations (EC) No 894/97, (EC) No 850/98, (EC) No 2549/2000, (EC) No 254/2002, (EC) No 812/2004 and (EC) No 2187/2005 (1), in particular Article 15(2) thereof,

Whereas:

| (1) | Annex V to Regulation (EU) 2019/1241 provides for technical measures established at regional level for the North Sea, Skagerrak and Kattegat. |
| --- | --- |

(1)

Annex V to Regulation (EU) 2019/1241 provides for technical measures established at regional level for the North Sea, Skagerrak and Kattegat.

| (2) | Where Member States having a direct management interest in a fishery consider that alternative measures are compatible with the protection of juveniles through the use of alternative selectivity devices to those established at regional level and set out in Part B of Annexes V to XI to Regulation (EU) 2019/1241, the Commission may adopt such measures by means of delegated acts upon a joint recommendation submitted by those Member States. |
| --- | --- |

(2)

Where Member States having a direct management interest in a fishery consider that alternative measures are compatible with the protection of juveniles through the use of alternative selectivity devices to those established at regional level and set out in Part B of Annexes V to XI to Regulation (EU) 2019/1241, the Commission may adopt such measures by means of delegated acts upon a joint recommendation submitted by those Member States.

| (3) | According to Article 16 of Regulation (EU) 2019/1241, Member States having a direct management interest in a fishery can submit a joint recommendation to the Commission for the purposes of adopting technical measures as referred to in Article 15(2) of that Regulation in relation to size-selective and species-selective characteristics of gear. Member States submitting such a recommendation are to provide scientific evidence demonstrating that those measures result in selectivity characteristics for specific species or combination of species which are at least equivalent to the selectivity characteristics of the gear set out in Part B of Annexes V to X and in Part A of Annex XI to that Regulation. |
| --- | --- |

(3)

According to Article 16 of Regulation (EU) 2019/1241, Member States having a direct management interest in a fishery can submit a joint recommendation to the Commission for the purposes of adopting technical measures as referred to in Article 15(2) of that Regulation in relation to size-selective and species-selective characteristics of gear. Member States submitting such a recommendation are to provide scientific evidence demonstrating that those measures result in selectivity characteristics for specific species or combination of species which are at least equivalent to the selectivity characteristics of the gear set out in Part B of Annexes V to X and in Part A of Annex XI to that Regulation.

| (4) | Belgium, Denmark, Germany, France, the Netherlands and Sweden (‘Scheveningen Group’) have a direct fisheries management interest in the North Sea fisheries. After consulting the North Sea Advisory Council, the Scheveningen Group submitted on 26 February 2020 a joint recommendation to the Commission on the basis of Article 15 of Regulation (EU) 2019/1241 proposing a delegated act to amend Part B of Annex V to that Regulation to allow the use of a species-selective device in the North Sea fishery for Norway pout as an alternative to the sorting grid with a maximum bar spacing of 35mm as defined in Part B of Annex V to that Regulation, as the baseline measure for that directed fishery. |
| --- | --- |

(4)

Belgium, Denmark, Germany, France, the Netherlands and Sweden (‘Scheveningen Group’) have a direct fisheries management interest in the North Sea fisheries. After consulting the North Sea Advisory Council, the Scheveningen Group submitted on 26 February 2020 a joint recommendation to the Commission on the basis of Article 15 of Regulation (EU) 2019/1241 proposing a delegated act to amend Part B of Annex V to that Regulation to allow the use of a species-selective device in the North Sea fishery for Norway pout as an alternative to the sorting grid with a maximum bar spacing of 35mm as defined in Part B of Annex V to that Regulation, as the baseline measure for that directed fishery.

| (5) | The Fisheries Expert Group was consulted on the joint recommendation on 30 September 2021. The European Parliament attended the meeting as an observer. |
| --- | --- |

(5)

The Fisheries Expert Group was consulted on the joint recommendation on 30 September 2021. The European Parliament attended the meeting as an observer.

| (6) | The Scientific, Technical and Economic Committee for Fisheries (‘STECF’) concluded (2) that the use of an excluder device would likely result in reduced by-catch rates (in weight and number) and a maintained or improved exploitation pattern for bycatch species that grow larger than Norway pout (such as gadoids) compared with use of the sorting grid. STECF noted that individuals smaller than 15 cm constitute only a small proportion of the overall by-catch and concluded that by-catches in the Norway pout fishery would hence be substantially reduced with the excluder when compared to the sorting grid. |
| --- | --- |

(6)

The Scientific, Technical and Economic Committee for Fisheries (‘STECF’) concluded (2) that the use of an excluder device would likely result in reduced by-catch rates (in weight and number) and a maintained or improved exploitation pattern for bycatch species that grow larger than Norway pout (such as gadoids) compared with use of the sorting grid. STECF noted that individuals smaller than 15 cm constitute only a small proportion of the overall by-catch and concluded that by-catches in the Norway pout fishery would hence be substantially reduced with the excluder when compared to the sorting grid.

| (7) | Regulation (EU) 2019/1241 should therefore be amended accordingly. |
| --- | --- |

(7)

Regulation (EU) 2019/1241 should therefore be amended accordingly.

| (8) | As the measures provided for in this Regulation have a direct impact on the planning of the fishing season of Union vessels and on related economic activities, this Regulation should enter into force immediately after its publication. Since the Norway pout fishery is from September to December, this Regulation should apply from 1 September 2021. Such retroactive application does not affect the principle of legal certainty and protection of legitimate expectations, |
| --- | --- |

(8)

As the measures provided for in this Regulation have a direct impact on the planning of the fishing season of Union vessels and on related economic activities, this Regulation should enter into force immediately after its publication. Since the Norway pout fishery is from September to December, this Regulation should apply from 1 September 2021. Such retroactive application does not affect the principle of legal certainty and protection of legitimate expectations,

HAS ADOPTED THIS REGULATION:

Article 1

Annex V to Regulation (EU) 2019/1241 is amended as set out in the Annex to this Regulation.

Article 2

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

It shall apply from 1 September 2021.

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

Done at Brussels, 2 December 2021.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 198, 25.7.2019, p. 105.

1

(2)  https://stecf.jrc.ec.europa.eu/documents/43805/2786172/STECF+PLEN+20-03.pdf

2

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ANNEX

In Annex V, Part B, point 1.4, the ninth entry of the table is amended as follows:

| Mesh Size | Geographical Areas | Conditions |
| --- | --- | --- |
| ‘At least 16 mm | Whole area | Directed fishing for small pelagic species which are not covered elsewhere in the table.
  Directed fishing for Norway pout. One of the following devices shall be fitted:






  (1) | a sorting grid with a maximum bar spacing of 35 mm; |

Mesh Size

Geographical Areas

Conditions

‘At least 16 mm

Whole area

Directed fishing for small pelagic species which are not covered elsewhere in the table.

Directed fishing for Norway pout. One of the following devices shall be fitted:

(1)

a sorting grid with a maximum bar spacing of 35 mm;

| (2) | an excluder device (*1), provided that the following conditions are fulfilled:






  (i) | the excluder shall have a maximum mesh size of 70mm and shall be mounted with a kite made of PVC or similar flexible materials; |
| --- | --- | --- |

(2)

an excluder device (*1), provided that the following conditions are fulfilled:

(i)

the excluder shall have a maximum mesh size of 70mm and shall be mounted with a kite made of PVC or similar flexible materials;

| (ii) | where a sail is mounted inside the excluder device across the cone/tube of that device, that sail shall be made of PVC or similar flexible material and the size of the sail shall be such that it does not cover more than 75 % of the cross-section area where it is positioned; and |
| --- | --- |

(ii)

where a sail is mounted inside the excluder device across the cone/tube of that device, that sail shall be made of PVC or similar flexible material and the size of the sail shall be such that it does not cover more than 75 % of the cross-section area where it is positioned; and

| (iii) | an exit hole of a minimum 50 x 50 cm shall be inserted at the apex of the excluder device. |
| --- | --- |

(iii)

an exit hole of a minimum 50 x 50 cm shall be inserted at the apex of the excluder device.

Directed fishing for common and Aesop shrimps. A separator trawl or sorting grid shall be fitted in accordance with nationally or regionally established rules.

---

(*1)  
  “Excluder device” means a conic net device fulfilling the following criteria:

*1

| (1) | it is inserted before the cod-end, in such a way that the leading edge or base of the cone is attached to the full circumference of the trawl in front of the cod-end or extension piece; |
| --- | --- |

(1)

it is inserted before the cod-end, in such a way that the leading edge or base of the cone is attached to the full circumference of the trawl in front of the cod-end or extension piece;

| (2) | it tapers to an apex where it is attached to the bottom sheet of the trawl; |
| --- | --- |

(2)

it tapers to an apex where it is attached to the bottom sheet of the trawl;

| (3) | an exit hole is cut where the apex of the excluder and cod-end join; |
| --- | --- |

(3)

an exit hole is cut where the apex of the excluder and cod-end join;

| (4) | it allows for the passage of Norway pout through it and its retention in the cod-end, whilst releasing by-catches of fish by guiding them out of the exit hole.’ |
| --- | --- |

(4)

it allows for the passage of Norway pout through it and its retention in the cod-end, whilst releasing by-catches of fish by guiding them out of the exit hole.’

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| 15.2.2022 | EN | Official Journal of the European Union | L 33/4 |
| --- | --- | --- | --- |

15.2.2022

EN

Official Journal of the European Union

L 33/4

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COMMISSION DELEGATED REGULATION (EU) 2022/200

of 2 December 2021

amending Regulation (EU) 2019/1241 of the European Parliament and of the Council as regards certain technical measures on mesh sizes and the overall maximum length for certain beam trawls in the North Sea

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2019/1241 of the European Parliament and of the Council of 20 June 2019 on the conservation of fisheries resources and the protection of marine ecosystems through technical measures, amending Council Regulations (EC) No 1967/2006, (EC) No 1224/2009 and Regulations (EU) No 1380/2013, (EU) 2016/1139, (EU) 2018/973, (EU) 2019/472 and (EU) 2019/1022 of the European Parliament and of the Council, and repealing Council Regulations (EC) No 894/97, (EC) No 850/98, (EC) No 2549/2000, (EC) No 254/2002, (EC) No 812/2004 and (EC) No 2187/2005 (1), and in particular Article 15(2) thereof,

Whereas:

| (1) | Regulation (EU) 2019/1241, Annex V provides for technical measures established at regional level for the North Sea. |
| --- | --- |

(1)

Regulation (EU) 2019/1241, Annex V provides for technical measures established at regional level for the North Sea.

| (2) | Belgium, Denmark, Germany, France, the Netherlands and Sweden (‘Scheveningen Group’) have a direct fisheries management interest in the North Sea. On 7 May and on 21 June 2021, the Scheveningen Group submitted joint recommendations to the Commission in accordance with Article 18(1) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council (2) and Article 15(3) of Regulation (EU) 2019/1241, proposing a delegated act adopting certain modifications of the current provisions set out in Annex V of Regulation (EU) 2019/1241. Both joint recommendations were sent by the Scheveningen Group to the Pelagic Advisory Council (PELAC) and the North Sea Advisory Council (NSAC) for consultation. |
| --- | --- |

(2)

Belgium, Denmark, Germany, France, the Netherlands and Sweden (‘Scheveningen Group’) have a direct fisheries management interest in the North Sea. On 7 May and on 21 June 2021, the Scheveningen Group submitted joint recommendations to the Commission in accordance with Article 18(1) of Regulation (EU) No 1380/2013 of the European Parliament and of the Council (2) and Article 15(3) of Regulation (EU) 2019/1241, proposing a delegated act adopting certain modifications of the current provisions set out in Annex V of Regulation (EU) 2019/1241. Both joint recommendations were sent by the Scheveningen Group to the Pelagic Advisory Council (PELAC) and the North Sea Advisory Council (NSAC) for consultation.

| (3) | The joint recommendation submitted on 7 May 2021 proposed amending Annex V, part B of Regulation (EU) 2019/1241 to limit the application of the 90 mm mesh size derogation in the Skagerrak to otter trawls only, where currently this mesh size is applicable to all towed gears, including beam trawls and seines. The recommendation also proposed that the derogation concerning the use of the 90 mm mesh size in Kattegat be limited to fishing with otter trawls or seines. |
| --- | --- |

(3)

The joint recommendation submitted on 7 May 2021 proposed amending Annex V, part B of Regulation (EU) 2019/1241 to limit the application of the 90 mm mesh size derogation in the Skagerrak to otter trawls only, where currently this mesh size is applicable to all towed gears, including beam trawls and seines. The recommendation also proposed that the derogation concerning the use of the 90 mm mesh size in Kattegat be limited to fishing with otter trawls or seines.

| (4) | The STECF analysed the evidence presented by the Member States and concluded (3) that the proposed amendment achieves its main aim of removing any ambiguity in the current regulations and confirms that vessels using seine nets or beam trawls cannot use the 90 mm mesh size in the Skagerrak. The proposed amendment will offer higher protection for juveniles, due to the fact that the 90 mm derogation is no longer available to beam trawls and seine nets in the Skagerrak or beam trawls in the Kattegat. Therefore, the joint recommendation is in line with the objectives and targets of Regulation (EU) 2019/1241 to the effect that catches of marine species below the minimum conservation reference size are to be reduced as far as possible. The proposed measure should therefore be included in Regulation (EU) 2019/1241. |
| --- | --- |

(4)

The STECF analysed the evidence presented by the Member States and concluded (3) that the proposed amendment achieves its main aim of removing any ambiguity in the current regulations and confirms that vessels using seine nets or beam trawls cannot use the 90 mm mesh size in the Skagerrak. The proposed amendment will offer higher protection for juveniles, due to the fact that the 90 mm derogation is no longer available to beam trawls and seine nets in the Skagerrak or beam trawls in the Kattegat. Therefore, the joint recommendation is in line with the objectives and targets of Regulation (EU) 2019/1241 to the effect that catches of marine species below the minimum conservation reference size are to be reduced as far as possible. The proposed measure should therefore be included in Regulation (EU) 2019/1241.

| (5) | The joint recommendation submitted on 21 June 2021 proposed the introduction of an overall maximum length for beam trawls of 24 m, while keeping in place the tighter restrictions for beam trawl in certain geographical areas already set out in Regulation (EU) 2019/1241. |
| --- | --- |

(5)

The joint recommendation submitted on 21 June 2021 proposed the introduction of an overall maximum length for beam trawls of 24 m, while keeping in place the tighter restrictions for beam trawl in certain geographical areas already set out in Regulation (EU) 2019/1241.

| (6) | The STECF analysed the evidence presented by the Member States and concluded (4) that, without the proposed restriction to 24 m, it is possible for fishermen to increase the length of the beam, potentially increasing the impact on the seabed and disturbance of the benthos habitat. The STECF therefore supported amending the provisions of Regulation (EU) 2019/1241 that the maximum length of the beam or the aggregate beam length measured as the sum of the length of each beam does not exceed 24 m. According to the STECF, this amendment will prevent an increase in negative impact on marine habitats and on the environment in line with the objectives in Regulation (EU) 2019/1241. It will thus ensure levels of protection that are at least equivalent to what is currently in force. The proposed measure should therefore be included in Regulation (EU) 2019/1241. |
| --- | --- |

(6)

The STECF analysed the evidence presented by the Member States and concluded (4) that, without the proposed restriction to 24 m, it is possible for fishermen to increase the length of the beam, potentially increasing the impact on the seabed and disturbance of the benthos habitat. The STECF therefore supported amending the provisions of Regulation (EU) 2019/1241 that the maximum length of the beam or the aggregate beam length measured as the sum of the length of each beam does not exceed 24 m. According to the STECF, this amendment will prevent an increase in negative impact on marine habitats and on the environment in line with the objectives in Regulation (EU) 2019/1241. It will thus ensure levels of protection that are at least equivalent to what is currently in force. The proposed measure should therefore be included in Regulation (EU) 2019/1241.

| (7) | Given that both joint recommendations propose changes to Annex V of Regulation (EU) 2019/1241, this delegated Regulation provides for all the measures recommended by the Scheveningen Group. |
| --- | --- |

(7)

Given that both joint recommendations propose changes to Annex V of Regulation (EU) 2019/1241, this delegated Regulation provides for all the measures recommended by the Scheveningen Group.

| (8) | The measures in this Regulation applicable to Union waters are in pursuit of the objectives set out in Article 494(1) and (2) of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, and have regard to the principles referred to in Article 494(3) of that agreement. They are without prejudice to any measures applicable in waters of the United Kingdom of Great Britain and Northern Ireland. |
| --- | --- |

(8)

The measures in this Regulation applicable to Union waters are in pursuit of the objectives set out in Article 494(1) and (2) of the Trade and Cooperation Agreement between the European Union and the European Atomic Energy Community, of the one part, and the United Kingdom of Great Britain and Northern Ireland, of the other part, and have regard to the principles referred to in Article 494(3) of that agreement. They are without prejudice to any measures applicable in waters of the United Kingdom of Great Britain and Northern Ireland.

| (9) | As the measures provided for in this Regulation have a direct impact on the planning of the fishing season of Union vessels and on related economic activities, this Regulation should enter into force immediately after its publication, |
| --- | --- |

(9)

As the measures provided for in this Regulation have a direct impact on the planning of the fishing season of Union vessels and on related economic activities, this Regulation should enter into force immediately after its publication,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EU) 2019/1241 is amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the 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, 2 December 2021.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 198, 25.7.2019, p. 105.

1

(2)  Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22).

2

(3)  STECF-21-05, p. 25.

3

(4)  STECF PLEN-21-02, p. 59.

4

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ANNEX

Part B of Annex V to Regulation (EU) 2019/1241 is amended as follows:

| (1) | The heading of point 1 is replaced by:






  ‘1. | Baseline mesh sizes for towed gear (*1) |
| --- | --- | --- |

(1)

The heading of point 1 is replaced by:

‘1.

Baseline mesh sizes for towed gear (*1)

(*1)  When fishing with beam trawls the maximum length of the beam or the aggregate beam length measured as the sum of the length of each beam shall not exceed 24 metres or cannot be extended to a length greater than 24 metres. The length of a beam shall be measured between its extremities including all attachments thereto. This is without prejudice to more specific measures established in certain areas of the North Sea.’
  "

| (2) | Point 1.1 is replaced by:






  ‘1.1. | Without prejudice to the landing obligation, vessels shall use a mesh size of at least 120 mm, or at least 90 mm in Skagerrak when fishing with otter trawls, or at least 90 mm in Kattegat when fishing with otter trawls or seines (*2)
   (*3). |
| --- | --- | --- |

(2)

Point 1.1 is replaced by:

‘1.1.

Without prejudice to the landing obligation, vessels shall use a mesh size of at least 120 mm, or at least 90 mm in Skagerrak when fishing with otter trawls, or at least 90 mm in Kattegat when fishing with otter trawls or seines (*2)
   (*3).

(*2)  When fishing in sub-divisions Skagerrak and Kattegat with otter trawls with a mesh size of less than 120 mm, a diamond mesh top panel of at least 270 mm mesh size or a square mesh top panel of at least 140 mm mesh size shall be fitted. Alternatively, in sub-division Kattegat, a square mesh panel of at least 120 mm may be fitted in the period from 1 October to 31 December."

(*3)  When fishing in sub-division Kattegat with seines with a mesh size of less than 120 mm, a diamond mesh top panel of at least 270 mm mesh size or a square mesh top panel of at least 140 mm mesh size shall be fitted. Alternatively, a square mesh panel of at least 120 mm may be fitted in the period from 1 August to 31 October.’
  "

---

(*1)  When fishing with beam trawls the maximum length of the beam or the aggregate beam length measured as the sum of the length of each beam shall not exceed 24 metres or cannot be extended to a length greater than 24 metres. The length of a beam shall be measured between its extremities including all attachments thereto. This is without prejudice to more specific measures established in certain areas of the North Sea.’

(*2)  When fishing in sub-divisions Skagerrak and Kattegat with otter trawls with a mesh size of less than 120 mm, a diamond mesh top panel of at least 270 mm mesh size or a square mesh top panel of at least 140 mm mesh size shall be fitted. Alternatively, in sub-division Kattegat, a square mesh panel of at least 120 mm may be fitted in the period from 1 October to 31 December.

(*3)  When fishing in sub-division Kattegat with seines with a mesh size of less than 120 mm, a diamond mesh top panel of at least 270 mm mesh size or a square mesh top panel of at least 140 mm mesh size shall be fitted. Alternatively, a square mesh panel of at least 120 mm may be fitted in the period from 1 August to 31 October.’
  ’

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| 15.2.2022 | EN | Official Journal of the European Union | L 33/7 |
| --- | --- | --- | --- |

15.2.2022

EN

Official Journal of the European Union

L 33/7

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COMMISSION DELEGATED REGULATION (EU) 2022/201

of 10 December 2021

amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by design and production organisations, as well as procedures applied by the Agency, and correcting that Regulation

THE EUROPEAN COMMISSION,

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

Having regard to 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 (1), and in particular Article 19(1) and Article 62(13) thereof,

Whereas:

| (1) | Commission Regulation (EU) No 748/2012 (2) lays down the requirements for the design and production of civil aircraft as well as engines, propellers and parts to be installed therein. |
| --- | --- |

(1)

Commission Regulation (EU) No 748/2012 (2) lays down the requirements for the design and production of civil aircraft as well as engines, propellers and parts to be installed therein.

| (2) | In accordance with point 3.1(b) of Annex II to Regulation (EU) 2018/1139, approved design and production organisations must, as appropriate for the type of activity undertaken and the size of the organisation, implement and maintain a management system, to ensure compliance with the essential requirements set out in that Annex, manage safety risks and aim for the continuous improvement of that system. |
| --- | --- |

(2)

In accordance with point 3.1(b) of Annex II to Regulation (EU) 2018/1139, approved design and production organisations must, as appropriate for the type of activity undertaken and the size of the organisation, implement and maintain a management system, to ensure compliance with the essential requirements set out in that Annex, manage safety risks and aim for the continuous improvement of that system.

| (3) | Pursuant to Annex 19 ‘Safety Management’ to the Convention on International Civil Aviation, signed in Chicago on 7 December 1944 (the ‘Chicago Convention’), competent authorities are to require approved organisations that design and produce civil aircraft, as well as engines, propellers and parts to be installed therein, to implement a safety management system. |
| --- | --- |

(3)

Pursuant to Annex 19 ‘Safety Management’ to the Convention on International Civil Aviation, signed in Chicago on 7 December 1944 (the ‘Chicago Convention’), competent authorities are to require approved organisations that design and produce civil aircraft, as well as engines, propellers and parts to be installed therein, to implement a safety management system.

| (4) | Regulation (EU) No 748/2012 already requires approved design and production organisations to comply with some elements of the management system; however, this management system does not completely cover the Standards and Recommended Practices (SARPs) for such a safety management system established in Annex 19 to the Chicago Convention. Therefore, the missing elements of the management system should be added to the existing requirements. |
| --- | --- |

(4)

Regulation (EU) No 748/2012 already requires approved design and production organisations to comply with some elements of the management system; however, this management system does not completely cover the Standards and Recommended Practices (SARPs) for such a safety management system established in Annex 19 to the Chicago Convention. Therefore, the missing elements of the management system should be added to the existing requirements.

| (5) | In order to ensure a proportionate implementation and consistency with the approach used for continuing airworthiness organisations operating in the general aviation domain, design and production organisations, for which an approval is not mandatory under Regulation (EU) No 748/2012, should not be required to comply with all the elements of the management system. |
| --- | --- |

(5)

In order to ensure a proportionate implementation and consistency with the approach used for continuing airworthiness organisations operating in the general aviation domain, design and production organisations, for which an approval is not mandatory under Regulation (EU) No 748/2012, should not be required to comply with all the elements of the management system.

| (6) | All organisations, including those that have their principal place of business outside the Union, when they design and produce products and parts in accordance with Regulation (EU) No 748/2012, are already required to establish a mandatory and voluntary occurrence-reporting system. However, Regulation (EU) No 748/2012 should be amended to ensure that that occurrence-reporting system is aligned with the principles of Regulation (EU) No 376/2014 of the European Parliament and of the Council (3). |
| --- | --- |

(6)

All organisations, including those that have their principal place of business outside the Union, when they design and produce products and parts in accordance with Regulation (EU) No 748/2012, are already required to establish a mandatory and voluntary occurrence-reporting system. However, Regulation (EU) No 748/2012 should be amended to ensure that that occurrence-reporting system is aligned with the principles of Regulation (EU) No 376/2014 of the European Parliament and of the Council (3).

| (7) | In addition, the requirements for the Agency with regard to the tasks related to design certification, oversight and enforcement should be amended. |
| --- | --- |

(7)

In addition, the requirements for the Agency with regard to the tasks related to design certification, oversight and enforcement should be amended.

| (8) | A sufficient transition period should be provided for approved design organisations to ensure their compliance with the new rules and procedures introduced by this Regulation. |
| --- | --- |

(8)

A sufficient transition period should be provided for approved design organisations to ensure their compliance with the new rules and procedures introduced by this Regulation.

| (9) | The measures provided for in this Regulation are based on Opinion No 04/2020 (4), issued by the Agency in accordance with Article 76(1) of Regulation (EU) 2018/1139. |
| --- | --- |

(9)

The measures provided for in this Regulation are based on Opinion No 04/2020 (4), issued by the Agency in accordance with Article 76(1) of Regulation (EU) 2018/1139.

| (10) | Regulation (EU) No 748/2012 should therefore be amended accordingly. |
| --- | --- |

(10)

Regulation (EU) No 748/2012 should therefore be amended accordingly.

| (11) | Commission Delegated Regulation (EU) 2021/699 (5) introduced a requirement that any future holder of the type-certificate or restricted type-certificate for a large aeroplane is to ensure that the continuing structural integrity programme remains valid throughout the operational life of the aeroplane. In particular, point 21.A.101(h) was added in Annex I to Regulation (EU) No 748/2012 to the effect that certain future holders are to comply with certification specifications that provide at least an equivalent level of safety to points 26.300, 26.320 and 26.330 of Annex I to Commission Regulation (EU) 2015/640 (6). An error occurred by referring to point 26.320, which does not exist. Regulation (EU) No 748/2012 should therefore be corrected accordingly, |
| --- | --- |

(11)

Commission Delegated Regulation (EU) 2021/699 (5) introduced a requirement that any future holder of the type-certificate or restricted type-certificate for a large aeroplane is to ensure that the continuing structural integrity programme remains valid throughout the operational life of the aeroplane. In particular, point 21.A.101(h) was added in Annex I to Regulation (EU) No 748/2012 to the effect that certain future holders are to comply with certification specifications that provide at least an equivalent level of safety to points 26.300, 26.320 and 26.330 of Annex I to Commission Regulation (EU) 2015/640 (6). An error occurred by referring to point 26.320, which does not exist. Regulation (EU) No 748/2012 should therefore be corrected accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EU) No 748/2012 is amended as follows:

| (1) | in Article 8, the following paragraph 4 is added:

  ‘4.   By way of derogation from points 21.B.433(d)(1) and (2) of Annex I (Part 21), a design organisation that holds a valid approval certificate issued in accordance with Annex I (Part 21) may correct, until 7 March 2025, any findings of non-compliance related to the Annex I requirements introduced by Commission Delegated Regulation (EU) 2022/201 (*1).
  Where after 7 March 2025, the organisation has not closed such findings, the approval certificate shall be revoked, limited or suspended in whole or in part.


  (*1)  Commission Delegated Regulation (EU) 2022/201 of 10 December 2021 amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by design and production organisations, as well as procedures applied by the Agency, and correcting that Regulation (OJ L 33, ..., p. 7)’;" |
| --- | --- |

(1)

in Article 8, the following paragraph 4 is added:

‘4.   By way of derogation from points 21.B.433(d)(1) and (2) of Annex I (Part 21), a design organisation that holds a valid approval certificate issued in accordance with Annex I (Part 21) may correct, until 7 March 2025, any findings of non-compliance related to the Annex I requirements introduced by Commission Delegated Regulation (EU) 2022/201 (*1).

Where after 7 March 2025, the organisation has not closed such findings, the approval certificate shall be revoked, limited or suspended in whole or in part.

(*1)  Commission Delegated Regulation (EU) 2022/201 of 10 December 2021 amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by design and production organisations, as well as procedures applied by the Agency, and correcting that Regulation (OJ L 33, ..., p. 7)’;"

*1

| (2) | Annex I (Part 21) is amended in accordance with Annex I to this Regulation. |
| --- | --- |

(2)

Annex I (Part 21) is amended in accordance with Annex I to this Regulation.

Article 2

Annex I (Part 21) to Regulation (EU) No 748/2012 is corrected in accordance with Annex II to this Regulation.

Article 3

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 7 March 2023, with the exception of Article 2 which shall apply from 7 March 2022.

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

Done at Brussels, 10 December 2021.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  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

(3)  Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18).

3

(4)  https://www.easa.europa.eu/document-library/opinions

4

(5)  Commission Delegated Regulation (EU) 2021/699 of 21 December 2020 amending and correcting Regulation (EU) No 748/2012 as regards the instructions for continued airworthiness, the production of parts to be used during maintenance and the consideration of ageing aircraft aspects during certification (OJ L 145, 28.4.2021, p. 1).

5

(6)  Commission Regulation (EU) 2015/640 of 23 April 2015 on additional airworthiness specifications for a given type of operations and amending Regulation (EU) No 965/2012 (OJ L 106, 24.4.2015, p. 18).

6

---

ANNEX I

Annex I (Part 21) is amended as follows:

| (1) | the table of contents is replaced by the following:

  ‘
  Contents








  21.1 | Competent authority |
| --- | --- | --- |

(1)

the table of contents is replaced by the following:

‘
  Contents

21.1

| 21.2 | Scope |
| --- | --- |

21.2

SECTION A – TECHNICAL REQUIREMENTS

SUBPART A – GENERAL PROVISIONS

| 21.A.1 | Scope |
| --- | --- |

21.A.1

| 21.A.2 | Undertaking by another person than the applicant for, or holder of, a certificate |
| --- | --- |

21.A.2

| 21.A.3A | Reporting system |
| --- | --- |

21.A.3A

| 21.A.3B | Airworthiness directives |
| --- | --- |

21.A.3B

| 21.A.4 | Coordination between design and production |
| --- | --- |

21.A.4

| 21.A.5 | Record-keeping |
| --- | --- |

21.A.5

| 21.A.6 | Manuals |
| --- | --- |

21.A.6

| 21.A.7 | Instructions for continued airworthiness |
| --- | --- |

21.A.7

| 21.A.9 | Access and investigation |
| --- | --- |

21.A.9

SUBPART B – TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES

| 21.A.11 | Scope |
| --- | --- |

21.A.11

| 21.A.13 | Eligibility |
| --- | --- |

21.A.13

| 21.A.14 | Demonstration of capability |
| --- | --- |

21.A.14

| 21.A.15 | Application |
| --- | --- |

21.A.15

| 21.A.19 | Changes requiring a new type-certificate |
| --- | --- |

21.A.19

| 21.A.20 | Demonstration of compliance with the type-certification basis, operational suitability data certification basis and environmental protection requirements |
| --- | --- |

21.A.20

| 21.A.21 | Requirements for the issuance of a type-certificate or restricted type-certificate |
| --- | --- |

21.A.21

| 21.A.31 | Type design |
| --- | --- |

21.A.31

| 21.A.33 | Inspections and tests |
| --- | --- |

21.A.33

| 21.A.35 | Flight tests |
| --- | --- |

21.A.35

| 21.A.41 | Type-certificate |
| --- | --- |

21.A.41

| 21.A.44 | Obligations of the holder |
| --- | --- |

21.A.44

| 21.A.47 | Transferability |
| --- | --- |

21.A.47

| 21.A.51 | Duration and continued validity |
| --- | --- |

21.A.51

| 21.A.62 | Availability of operational suitability data |
| --- | --- |

21.A.62

| 21.A.65 | Continuing structural integrity for aeroplanes structures |
| --- | --- |

21.A.65

(SUBPART C – NOT APPLICABLE)

SUBPART D – CHANGES TO TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES

| 21.A.90A | Scope |
| --- | --- |

21.A.90A

| 21.A.90B | Standard changes |
| --- | --- |

21.A.90B

| 21.A.90C | Stand-alone changes to the instructions for continued airworthiness |
| --- | --- |

21.A.90C

| 21.A.91 | Classification of changes to a type-certificate |
| --- | --- |

21.A.91

| 21.A.92 | Eligibility |
| --- | --- |

21.A.92

| 21.A.93 | Application |
| --- | --- |

21.A.93

| 21.A.95 | Requirements for approval of a minor change |
| --- | --- |

21.A.95

| 21.A.97 | Requirements for approval of a major change |
| --- | --- |

21.A.97

| 21.A.101 | Type-certification basis, operational suitability data certification basis and environmental protection requirements for a major change to a type-certificate |
| --- | --- |

21.A.101

| 21.A.108 | Availability of operational suitability data |
| --- | --- |

21.A.108

| 21.A.109 | Obligations and EPA marking |
| --- | --- |

21.A.109

SUBPART E – SUPPLEMENTAL TYPE-CERTIFICATES

| 21.A.111 | Scope |
| --- | --- |

21.A.111

| 21.A.112A | Eligibility |
| --- | --- |

21.A.112A

| 21.A.112B | Demonstration of capability |
| --- | --- |

21.A.112B

| 21.A.113 | Application for a supplemental type-certificate |
| --- | --- |

21.A.113

| 21.A.115 | Requirements for approval of major changes in the form of a supplemental type-certificate |
| --- | --- |

21.A.115

| 21.A.116 | Transferability |
| --- | --- |

21.A.116

| 21.A.117 | Changes to that part of a product covered by a supplemental type-certificate |
| --- | --- |

21.A.117

| 21.A.118A | Obligations and EPA marking |
| --- | --- |

21.A.118A

| 21.A.118B | Duration and continued validity |
| --- | --- |

21.A.118B

| 21.A.120B | Availability of operational suitability data |
| --- | --- |

21.A.120B

SUBPART F – PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL

| 21.A.121 | Scope |
| --- | --- |

21.A.121

| 21.A.122 | Eligibility |
| --- | --- |

21.A.122

| 21.A.124 | Application |
| --- | --- |

21.A.124

| 21.A.124A | Means of compliance |
| --- | --- |

21.A.124A

| 21.A.125A | Issuance of a letter of agreement |
| --- | --- |

21.A.125A

| 21.A.125B | Findings and observations |
| --- | --- |

21.A.125B

| 21.A.125C | Duration and continued validity |
| --- | --- |

21.A.125C

| 21.A.126 | Production inspection system |
| --- | --- |

21.A.126

| 21.A.127 | Tests: aircraft |
| --- | --- |

21.A.127

| 21.A.128 | Tests: engines and propellers |
| --- | --- |

21.A.128

| 21.A.129 | Obligations of the production organisation |
| --- | --- |

21.A.129

| 21.A.130 | Statement of conformity |
| --- | --- |

21.A.130

SUBPART G – PRODUCTION ORGANISATION APPROVAL

| 21.A.131 | Scope |
| --- | --- |

21.A.131

| 21.A.133 | Eligibility |
| --- | --- |

21.A.133

| 21.A.134 | Application |
| --- | --- |

21.A.134

| 21.A.134A | Means of compliance |
| --- | --- |

21.A.134A

| 21.A.135 | Issuance of production organisation approval |
| --- | --- |

21.A.135

| 21.A.139 | Production management system |
| --- | --- |

21.A.139

| 21.A.143 | Production organisation exposition |
| --- | --- |

21.A.143

| 21.A.145 | Resources |
| --- | --- |

21.A.145

| 21.A.147 | Changes in the production management system |
| --- | --- |

21.A.147

| 21.A.148 | Changes of location |
| --- | --- |

21.A.148

| 21.A.149 | Transferability |
| --- | --- |

21.A.149

| 21.A.151 | Terms of approval |
| --- | --- |

21.A.151

| 21.A.153 | Changes to the terms of approval |
| --- | --- |

21.A.153

| 21.A.158 | Findings and observations |
| --- | --- |

21.A.158

| 21.A.159 | Duration and continued validity |
| --- | --- |

21.A.159

| 21.A.163 | Privileges |
| --- | --- |

21.A.163

| 21.A.165 | Obligations of the holder |
| --- | --- |

21.A.165

SUBPART H – CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS

| 21.A.171 | Scope |
| --- | --- |

21.A.171

| 21.A.172 | Eligibility |
| --- | --- |

21.A.172

| 21.A.173 | Classification |
| --- | --- |

21.A.173

| 21.A.174 | Application |
| --- | --- |

21.A.174

| 21.A.175 | Language |
| --- | --- |

21.A.175

| 21.A.177 | Amendment or modification |
| --- | --- |

21.A.177

| 21.A.179 | Transferability and re-issuance within Member States |
| --- | --- |

21.A.179

| 21.A.181 | Duration and continued validity |
| --- | --- |

21.A.181

| 21.A.182 | Aircraft identification |
| --- | --- |

21.A.182

SUBPART I – NOISE CERTIFICATES

| 21.A.201 | Scope |
| --- | --- |

21.A.201

| 21.A.203 | Eligibility |
| --- | --- |

21.A.203

| 21.A.204 | Application |
| --- | --- |

21.A.204

| 21.A.207 | Amendment or modification |
| --- | --- |

21.A.207

| 21.A.209 | Transferability and re-issuance within Member States |
| --- | --- |

21.A.209

| 21.A.211 | Duration and continued validity |
| --- | --- |

21.A.211

SUBPART J – DESIGN ORGANISATION APPROVAL

| 21.A.231 | Scope |
| --- | --- |

21.A.231

| 21.A.233 | Eligibility |
| --- | --- |

21.A.233

| 21.A.234 | Application |
| --- | --- |

21.A.234

| 21.A.235 | Issue of design organisation approval |
| --- | --- |

21.A.235

| 21.A.239 | Design management system |
| --- | --- |

21.A.239

| 21.A.243 | Handbook |
| --- | --- |

21.A.243

| 21.A.245 | Resources |
| --- | --- |

21.A.245

| 21.A.247 | Changes in the design management system |
| --- | --- |

21.A.247

| 21.A.249 | Transferability |
| --- | --- |

21.A.249

| 21.A.251 | Terms of approval |
| --- | --- |

21.A.251

| 21.A.253 | Changes to the terms of approval |
| --- | --- |

21.A.253

| 21.A.258 | Findings and observations |
| --- | --- |

21.A.258

| 21.A.259 | Duration and continued validity |
| --- | --- |

21.A.259

| 21.A.263 | Privileges |
| --- | --- |

21.A.263

| 21.A.265 | Obligations of the holder |
| --- | --- |

21.A.265

SUBPART K – PARTS AND APPLIANCES

| 21.A.301 | Scope |
| --- | --- |

21.A.301

| 21.A.303 | Compliance with applicable requirements |
| --- | --- |

21.A.303

| 21.A.305 | Approval of parts and appliances |
| --- | --- |

21.A.305

| 21.A.307 | The eligibility of parts and appliances for installation |
| --- | --- |

21.A.307

(SUBPART L – NOT APPLICABLE)

SUBPART M – REPAIRS

| 21.A.431A | Scope |
| --- | --- |

21.A.431A

| 21.A.431B | Standard repairs |
| --- | --- |

21.A.431B

| 21.A.432A | Eligibility |
| --- | --- |

21.A.432A

| 21.A.432B | Demonstration of capability |
| --- | --- |

21.A.432B

| 21.A.432C | Application for a repair design approval |
| --- | --- |

21.A.432C

| 21.A.433 | Requirements for approval of a repair design |
| --- | --- |

21.A.433

| 21.A.435 | Classification and approval of repair designs |
| --- | --- |

21.A.435

| 21.A.439 | Production of repair parts |
| --- | --- |

21.A.439

| 21.A.441 | Repair embodiment |
| --- | --- |

21.A.441

| 21.A.443 | Limitations |
| --- | --- |

21.A.443

| 21.A.445 | Unrepaired damage |
| --- | --- |

21.A.445

| 21.A.451 | Obligations and EPA marking |
| --- | --- |

21.A.451

(SUBPART N – NOT APPLICABLE)

SUBPART O – EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS

| 21.A.601 | Scope |
| --- | --- |

21.A.601

| 21.A.602A | Eligibility |
| --- | --- |

21.A.602A

| 21.A.602B | Demonstration of capability |
| --- | --- |

21.A.602B

| 21.A.603 | Application |
| --- | --- |

21.A.603

| 21.A.604 | ETSO authorisation for an auxiliary power unit (APU) |
| --- | --- |

21.A.604

| 21.A.605 | Data requirements |
| --- | --- |

21.A.605

| 21.A.606 | Requirements for issuance of an ETSO authorisation |
| --- | --- |

21.A.606

| 21.A.607 | ETSO authorisation privileges |
| --- | --- |

21.A.607

| 21.A.608 | Declaration of design and performance (DDP) |
| --- | --- |

21.A.608

| 21.A.609 | Obligations of holders of ETSO authorisations |
| --- | --- |

21.A.609

| 21.A.610 | Approval for deviation |
| --- | --- |

21.A.610

| 21.A.611 | Design changes |
| --- | --- |

21.A.611

| 21.A.619 | Duration and continued validity |
| --- | --- |

21.A.619

| 21.A.621 | Transferability |
| --- | --- |

21.A.621

SUBPART P – PERMIT TO FLY

| 21.A.701 | Scope |
| --- | --- |

21.A.701

| 21.A.703 | Eligibility |
| --- | --- |

21.A.703

| 21.A.707 | Application for permit to fly |
| --- | --- |

21.A.707

| 21.A.708 | Flight conditions |
| --- | --- |

21.A.708

| 21.A.709 | Application for approval of flight conditions |
| --- | --- |

21.A.709

| 21.A.710 | Approval of flight conditions |
| --- | --- |

21.A.710

| 21.A.711 | Issuance of a permit to fly |
| --- | --- |

21.A.711

| 21.A.713 | Changes |
| --- | --- |

21.A.713

| 21.A.715 | Language |
| --- | --- |

21.A.715

| 21.A.719 | Transferability |
| --- | --- |

21.A.719

| 21.A.723 | Duration and continued validity |
| --- | --- |

21.A.723

| 21.A.725 | Renewal of permit to fly |
| --- | --- |

21.A.725

| 21.A.727 | Obligations of the holder of a permit to fly |
| --- | --- |

21.A.727

SUBPART Q – IDENTIFICATION OF PRODUCTS, PARTS AND APPLIANCES

| 21.A.801 | Identification of products |
| --- | --- |

21.A.801

| 21.A.803 | Handling of identification data |
| --- | --- |

21.A.803

| 21.A.804 | Identification of parts and appliances |
| --- | --- |

21.A.804

| 21.A.805 | Identification of critical parts |
| --- | --- |

21.A.805

| 21.A.807 | Identification of ETSO articles |
| --- | --- |

21.A.807

SECTION B – PROCEDURES FOR COMPETENT AUTHORITIES

SUBPART A – GENERAL PROVISIONS

| 21.B.10 | Oversight documentation |
| --- | --- |

21.B.10

| 21.B.15 | Information to the Agency |
| --- | --- |

21.B.15

| 21.B.20 | Immediate reaction to a safety problem |
| --- | --- |

21.B.20

| 21.B.25 | Management system |
| --- | --- |

21.B.25

| 21.B.30 | Allocation of tasks to qualified entities |
| --- | --- |

21.B.30

| 21.B.35 | Changes in the management system |
| --- | --- |

21.B.35

| 21.B.55 | Record-keeping |
| --- | --- |

21.B.55

| 21.B.65 | Suspension, limitation and revocation |
| --- | --- |

21.B.65

SUBPART B – TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES

| 21.B.70 | Certification specifications |
| --- | --- |

21.B.70

| 21.B.75 | Special conditions |
| --- | --- |

21.B.75

| 21.B.80 | Type-certification basis for a type-certificate or a restricted type-certificate |
| --- | --- |

21.B.80

| 21.B.82 | Operational suitability data certification basis for an aircraft type certificate or a restricted type-certificate |
| --- | --- |

21.B.82

| 21.B.85 | Designation of applicable environmental protection requirements for a type-certificate or a restricted type-certificate |
| --- | --- |

21.B.85

| 21.B.100 | Level of involvement |
| --- | --- |

21.B.100

| 21.B.103 | Issuance of a type-certificate or a restricted type-certificate |
| --- | --- |

21.B.103

(SUBPART C – NOT APPLICABLE)

SUBPART D – CHANGES TO TYPE-CERTIFICATES AND RESTRICTED TYPE-CERTIFICATES

| 21.B.105 | Type-certification basis, environmental protection requirements and operational suitability data certification basis for a major change to a type-certificate |
| --- | --- |

21.B.105

| 21.B.107 | Issuance of an approval of a change to a type-certificate |
| --- | --- |

21.B.107

SUBPART E – SUPPLEMENTAL TYPE-CERTIFICATES

| 21.B.109 | Type-certification basis, environmental protection requirements and operational suitability data certification basis for a supplemental type-certificate |
| --- | --- |

21.B.109

| 21.B.111 | Issuance of a supplemental type-certificate |
| --- | --- |

21.B.111

SUBPART F – PRODUCTION WITHOUT PRODUCTION ORGANISATION APPROVAL

| 21.B.115 | Means of compliance |
| --- | --- |

21.B.115

| 21.B.120 | Initial certification procedure |
| --- | --- |

21.B.120

| 21.B.125 | Findings and corrective actions; observations |
| --- | --- |

21.B.125

| 21.B.135 | Maintenance of the letter of agreement |
| --- | --- |

21.B.135

| 21.B.140 | Amendment of a letter of agreement |
| --- | --- |

21.B.140

SUBPART G – PRODUCTION ORGANISATION APPROVAL

| 21.B.215 | Means of compliance |
| --- | --- |

21.B.215

| 21.B.220 | Initial certification procedure |
| --- | --- |

21.B.220

| 21.B.221 | Oversight principles |
| --- | --- |

21.B.221

| 21.B.222 | Oversight programme |
| --- | --- |

21.B.222

| 21.B.225 | Findings and corrective actions; observations |
| --- | --- |

21.B.225

| 21.B.240 | Changes in the production management system |
| --- | --- |

21.B.240

SUBPART H – CERTIFICATES OF AIRWORTHINESS AND RESTRICTED CERTIFICATES OF AIRWORTHINESS

| 21.B.320 | Investigation |
| --- | --- |

21.B.320

| 21.B.325 | Issuance of airworthiness certificate |
| --- | --- |

21.B.325

| 21.B.326 | Certificate of airworthiness |
| --- | --- |

21.B.326

| 21.B.327 | Restricted certificate of airworthiness |
| --- | --- |

21.B.327

SUBPART I – NOISE CERTIFICATES

| 21.B.420 | Investigation |
| --- | --- |

21.B.420

| 21.B.425 | Issuance of noise certificates |
| --- | --- |

21.B.425

SUBPART J – DESIGN ORGANISATION APPROVAL

| 21.B.430 | Initial certification procedure |
| --- | --- |

21.B.430

| 21.B.431 | Oversight principles |
| --- | --- |

21.B.431

| 21.B.432 | Oversight programme |
| --- | --- |

21.B.432

| 21.B.433 | Findings and corrective actions; observations |
| --- | --- |

21.B.433

| 21.B.435 | Changes in the design management system |
| --- | --- |

21.B.435

SUBPART K – PARTS AND APPLIANCES

(SUBPART L – NOT APPLICABLE)

SUBPART M – REPAIRS

| 21.B.450 | Type-certification basis and environmental protection requirements for a major repair design approval |
| --- | --- |

21.B.450

| 21.B.453 | Issuance of a repair design approval |
| --- | --- |

21.B.453

(SUBPART N – NOT APPLICABLE)

SUBPART O – EUROPEAN TECHNICAL STANDARD ORDER AUTHORISATIONS

| 21.B.480 | Issuance of an ETSO authorisation |
| --- | --- |

21.B.480

SUBPART P – PERMIT TO FLY

| 21.B.520 | Investigation |
| --- | --- |

21.B.520

| 21.B.525 | Issuance of a permit to fly |
| --- | --- |

21.B.525

SUBPART Q – IDENTIFICATION OF PRODUCTS, PARTS AND APPLIANCES

Appendices

Appendix I – EASA Form 1 – Authorised Release Certificate

Appendix II – EASA Form 15a and 15c – Airworthiness Review Certificate

Appendix III – EASA Form 20a – Permit to Fly

Appendix IV – EASA Form 20b – Permit to Fly (issued by approved organisations)

Appendix V – EASA Form 24 – Restricted Certificate of Airworthiness

Appendix VI – EASA Form 25 – Certificate of Airworthiness

Appendix VII – EASA Form 45 – Noise Certificate

Appendix VIII – EASA Form 52 – Aircraft statement of conformity

Appendix IX – EASA Form 53 – Certificate of Release to Service

Appendix X – EASA Form 55 – Production organisation approval certificate

Appendix XI – EASA Form 65 – Letter of Agreement for production without production organisation approval

Appendix XII – Categories of flight tests and associated flight test crew qualification.’;

| (2) | point 21.A.1 is replaced by the following:
  ‘21.A.1   Scope

  This Subpart establishes the general rights and obligations of the applicant for, and holder of, any certificate that has been issued or is to be issued in accordance with this Annex.’; |
| --- | --- |

(2)

point 21.A.1 is replaced by the following:

‘21.A.1   Scope

This Subpart establishes the general rights and obligations of the applicant for, and holder of, any certificate that has been issued or is to be issued in accordance with this Annex.’;

| (3) | point 21.A.3A is replaced by the following:
  ‘21.A.3A   Reporting system







  (a) | Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council (*1) and its delegated and implementing acts, all natural or legal persons that have applied for or hold a type-certificate, restricted type-certificate, supplemental type-certificate, European Technical Standard Order (ETSO) authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation shall:






  1. | establish and maintain a system for collecting, investigating and analysing occurrence reports in order to identify adverse trends or to address deficiencies and to extract occurrences whose reporting is mandatory in accordance with point 3 and those which are reported voluntarily. When the principal place of business is located in a Member State, a single system may be established to meet the requirements of Regulation (EU) No 376/2014 of of the European Parliament and of the Council and its implementing acts and of Regulation (EU) 2018/1139 and its delegated and implementing acts. The reporting system shall include:






  (i) | reports of and information related to failures, malfunctions, defects or other occurrences which cause or might cause adverse effects on the continuing airworthiness of the product, part or appliance covered by the type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or by any other relevant approval deemed to have been issued under this Regulation; |
| --- | --- | --- | --- | --- |

(3)

point 21.A.3A is replaced by the following:

‘21.A.3A   Reporting system

(a)

Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council (*1) and its delegated and implementing acts, all natural or legal persons that have applied for or hold a type-certificate, restricted type-certificate, supplemental type-certificate, European Technical Standard Order (ETSO) authorisation, major repair design approval or any other relevant approval deemed to have been issued under this Regulation shall:

1.

establish and maintain a system for collecting, investigating and analysing occurrence reports in order to identify adverse trends or to address deficiencies and to extract occurrences whose reporting is mandatory in accordance with point 3 and those which are reported voluntarily. When the principal place of business is located in a Member State, a single system may be established to meet the requirements of Regulation (EU) No 376/2014 of of the European Parliament and of the Council and its implementing acts and of Regulation (EU) 2018/1139 and its delegated and implementing acts. The reporting system shall include:

(i)

reports of and information related to failures, malfunctions, defects or other occurrences which cause or might cause adverse effects on the continuing airworthiness of the product, part or appliance covered by the type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or by any other relevant approval deemed to have been issued under this Regulation;

| (ii) | errors, near misses and hazards that do not fall under point (i); |
| --- | --- |

(ii)

errors, near misses and hazards that do not fall under point (i);

| 2. | make available to known operators of the product, part or appliance and, on request, to any person authorised under other implementing or delegated acts the information about the system established in accordance with point 1, and on how to provide reports of and information related to failures, malfunctions, defects or other occurrences referred to in point 1(i); |
| --- | --- |

2.

make available to known operators of the product, part or appliance and, on request, to any person authorised under other implementing or delegated acts the information about the system established in accordance with point 1, and on how to provide reports of and information related to failures, malfunctions, defects or other occurrences referred to in point 1(i);

| 3. | report to the Agency any failure, malfunction, defect or other occurrence of which it is aware and is related to a product, part or appliance covered by the type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or by any other relevant approval deemed to have been issued under this Regulation, and which has resulted or may result in an unsafe condition. |
| --- | --- |

3.

report to the Agency any failure, malfunction, defect or other occurrence of which it is aware and is related to a product, part or appliance covered by the type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, major repair design approval or by any other relevant approval deemed to have been issued under this Regulation, and which has resulted or may result in an unsafe condition.

| (b) | Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, any natural or legal person that holds or has applied for a production organisation approval certificate under Subpart G of this Section, or that produces a product, part or appliance under Subpart F of this Section, shall:






  1. | establish and maintain a system for collecting and assessing occurrence reports, including reports on errors, near misses and hazards, in order to identify adverse trends or to address deficiencies and extract occurrences whose reporting is mandatory in accordance with points 2 and 3 and those which are reported voluntarily. For organisations that have their principal place of business in a Member State, a single system may be established to meet the requirements of Regulation (EU) No 376/2014 of the European Parliament and of the Council and its implementing acts and of Regulation (EU) 2018/1139 and its delegated and implementing acts; |
| --- | --- | --- |

(b)

Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, any natural or legal person that holds or has applied for a production organisation approval certificate under Subpart G of this Section, or that produces a product, part or appliance under Subpart F of this Section, shall:

1.

establish and maintain a system for collecting and assessing occurrence reports, including reports on errors, near misses and hazards, in order to identify adverse trends or to address deficiencies and extract occurrences whose reporting is mandatory in accordance with points 2 and 3 and those which are reported voluntarily. For organisations that have their principal place of business in a Member State, a single system may be established to meet the requirements of Regulation (EU) No 376/2014 of the European Parliament and of the Council and its implementing acts and of Regulation (EU) 2018/1139 and its delegated and implementing acts;

| 2. | report to the responsible design approval holder all the cases where products, parts or appliances have been released by the production organisation and possible deviations from the applicable design data have been subsequently identified, and investigate with the design approval holder to identify those deviations which could lead to an unsafe condition; |
| --- | --- |

2.

report to the responsible design approval holder all the cases where products, parts or appliances have been released by the production organisation and possible deviations from the applicable design data have been subsequently identified, and investigate with the design approval holder to identify those deviations which could lead to an unsafe condition;

| 3. | report to the competent authority of the Member State responsible in accordance with point 21.1 and the Agency the deviations that have been identified in accordance with point 21.A.3A(b)2 and which could lead to an unsafe condition; |
| --- | --- |

3.

report to the competent authority of the Member State responsible in accordance with point 21.1 and the Agency the deviations that have been identified in accordance with point 21.A.3A(b)2 and which could lead to an unsafe condition;

| 4. | if the production organisation acts as a supplier to another production organisation, also report to that other organisation all the cases where it has released products, parts or appliances to that organisation and possible deviations from the applicable design data have been subsequently identified. |
| --- | --- |

4.

if the production organisation acts as a supplier to another production organisation, also report to that other organisation all the cases where it has released products, parts or appliances to that organisation and possible deviations from the applicable design data have been subsequently identified.

| (c) | Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, any natural or legal person, when reporting in accordance with points (a)(3), (b)(2), (b)(3) and (b)(4), shall appropriately protect the confidentiality of the person who reports and of the person(s) mentioned in the report. |
| --- | --- |

(c)

Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, any natural or legal person, when reporting in accordance with points (a)(3), (b)(2), (b)(3) and (b)(4), shall appropriately protect the confidentiality of the person who reports and of the person(s) mentioned in the report.

| (d) | Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, any natural or legal person shall make the reports referred to in points (a)(3) and (b)(3) in a form and manner established by the Agency or the competent authority, respectively, and dispatch them as soon as practicable and in any case not later than 72 hours after the natural or legal person has identified that the occurrence may lead to a possible unsafe condition, unless exceptional circumstances prevent this. |
| --- | --- |

(d)

Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, any natural or legal person shall make the reports referred to in points (a)(3) and (b)(3) in a form and manner established by the Agency or the competent authority, respectively, and dispatch them as soon as practicable and in any case not later than 72 hours after the natural or legal person has identified that the occurrence may lead to a possible unsafe condition, unless exceptional circumstances prevent this.

| (e) | Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, if an occurrence reported under point (a)(3) or under point (b)(3) results from a deficiency in the design or a production deficiency, the holder of the type-certificate, restricted type-certificate, supplemental type-certificate, major repair design approval, ETSO authorisation or any other relevant approval deemed to have been issued under this Regulation, or the production organisation as appropriate, shall investigate the reason for the deficiency and report to the competent authority of the Member State responsible in accordance with point 21.1 and to the Agency the results of its investigation and any action it intends to take or proposes to be taken to correct that deficiency. |
| --- | --- |

(e)

Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, if an occurrence reported under point (a)(3) or under point (b)(3) results from a deficiency in the design or a production deficiency, the holder of the type-certificate, restricted type-certificate, supplemental type-certificate, major repair design approval, ETSO authorisation or any other relevant approval deemed to have been issued under this Regulation, or the production organisation as appropriate, shall investigate the reason for the deficiency and report to the competent authority of the Member State responsible in accordance with point 21.1 and to the Agency the results of its investigation and any action it intends to take or proposes to be taken to correct that deficiency.

| (f) | If the competent authority finds that action is required to correct the deficiency, the holder of the type-certificate, restricted type-certificate, supplemental type-certificate, major repair design approval, ETSO authorisation or any other relevant approval deemed to have been issued under this Regulation, or the production organisation as appropriate, shall submit the relevant data to the competent authority upon its request. |
| --- | --- |

(f)

If the competent authority finds that action is required to correct the deficiency, the holder of the type-certificate, restricted type-certificate, supplemental type-certificate, major repair design approval, ETSO authorisation or any other relevant approval deemed to have been issued under this Regulation, or the production organisation as appropriate, shall submit the relevant data to the competent authority upon its request.

(*1)  Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18).’;"

| (4) | point 21.A.5 is replaced by the following:
  ‘21.A.5   Record-keeping

  All natural or legal persons that hold or have applied for a type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, design or repair approval, permit to fly, production organisation approval certificate or letter of agreement under this Regulation shall:






  (a) | when they design a product, part or appliance or changes or repairs thereto, establish a record-keeping system and maintain the relevant design information/data; that information/data shall be made available to the Agency in order to provide the information/data that is necessary to ensure the continued airworthiness of the product, part or appliance, the continued validity of the operational suitability data, and compliance with the applicable environmental protection requirements; |
| --- | --- | --- |

(4)

point 21.A.5 is replaced by the following:

‘21.A.5   Record-keeping

All natural or legal persons that hold or have applied for a type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, design or repair approval, permit to fly, production organisation approval certificate or letter of agreement under this Regulation shall:

(a)

when they design a product, part or appliance or changes or repairs thereto, establish a record-keeping system and maintain the relevant design information/data; that information/data shall be made available to the Agency in order to provide the information/data that is necessary to ensure the continued airworthiness of the product, part or appliance, the continued validity of the operational suitability data, and compliance with the applicable environmental protection requirements;

| (b) | when they produce a product, part or appliance, record the details of the production process relevant to the conformity of the product, part or appliances with the applicable design data, and the requirements imposed on their partners and suppliers, and make that data available to their competent authority in order to provide the information that is necessary to ensure the continuing airworthiness of the product, part or appliance; |
| --- | --- |

(b)

when they produce a product, part or appliance, record the details of the production process relevant to the conformity of the product, part or appliances with the applicable design data, and the requirements imposed on their partners and suppliers, and make that data available to their competent authority in order to provide the information that is necessary to ensure the continuing airworthiness of the product, part or appliance;

| (c) | with regard to permits to fly:






  1. | maintain the documents that are produced to establish and justify the flight conditions, and make them available to the Agency and to their competent authority of the Member State in order to provide the information that is necessary to ensure the continued airworthiness of the aircraft; |
| --- | --- | --- |

(c)

with regard to permits to fly:

1.

maintain the documents that are produced to establish and justify the flight conditions, and make them available to the Agency and to their competent authority of the Member State in order to provide the information that is necessary to ensure the continued airworthiness of the aircraft;

| 2. | when they issue a permit to fly under the privilege of approved organisations, maintain the documents associated with it, including inspection records and documents that support the approval of the flight conditions and the issuance of the permit to fly itself, and make them available to the Agency and to their competent authority of the Member State responsible for the oversight of the organisation in order to provide the information that is necessary to ensure the continued airworthiness of the aircraft; |
| --- | --- |

2.

when they issue a permit to fly under the privilege of approved organisations, maintain the documents associated with it, including inspection records and documents that support the approval of the flight conditions and the issuance of the permit to fly itself, and make them available to the Agency and to their competent authority of the Member State responsible for the oversight of the organisation in order to provide the information that is necessary to ensure the continued airworthiness of the aircraft;

| (d) | retain records of the competence and qualifications, referred to in points 21.A.139(c), 21.A.145(b), 21.A.145(c), 21.A.239(c), 21.A.245(a) or 21.A.245(e)(1), of the personnel that are involved in the following functions:






  1. | design or production; |
| --- | --- | --- |

(d)

retain records of the competence and qualifications, referred to in points 21.A.139(c), 21.A.145(b), 21.A.145(c), 21.A.239(c), 21.A.245(a) or 21.A.245(e)(1), of the personnel that are involved in the following functions:

1.

design or production;

| 2. | independent monitoring of the compliance of the organisation with the relevant requirements; |
| --- | --- |

2.

independent monitoring of the compliance of the organisation with the relevant requirements;

| 3. | safety management; |
| --- | --- |

3.

safety management;

| (e) | retain records of the authorisation of personnel, when they employ personnel that:






  1. | exercise the privileges of the approved organisation pursuant to points 21.A.163 and/or 21.A.263, as appropriate; |
| --- | --- | --- |

(e)

retain records of the authorisation of personnel, when they employ personnel that:

1.

exercise the privileges of the approved organisation pursuant to points 21.A.163 and/or 21.A.263, as appropriate;

| 2. | carry out the independent function to monitor the compliance of the organisation with the relevant requirements pursuant to points 21.A.139(e) and/or 21.A.239(e), as appropriate; |
| --- | --- |

2.

carry out the independent function to monitor the compliance of the organisation with the relevant requirements pursuant to points 21.A.139(e) and/or 21.A.239(e), as appropriate;

| 3. | carry out the independent verification function of the demonstration of compliance pursuant to point 21.A.239(d)(2).’; |
| --- | --- |

3.

carry out the independent verification function of the demonstration of compliance pursuant to point 21.A.239(d)(2).’;

| (5) | the following point 21.A.9 is inserted:
  ‘21.A.9   Access and investigation

  Any natural or legal person that holds or has applied for a type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, design change or repair approval, certificate of airworthiness, noise certificate, permit to fly, design organisation approval, production organisation approval certificate or letter of agreement under this Regulation, shall:






  (a) | grant the competent authority access to any facility, product, part and appliance, document, record, data, process, procedure or to any other material in order to review any report, make any inspection, or perform or witness any flight and ground test, as necessary, in order to verify the initial and continued compliance of the organisation with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts.; |
| --- | --- | --- |

(5)

the following point 21.A.9 is inserted:

‘21.A.9   Access and investigation

Any natural or legal person that holds or has applied for a type-certificate, restricted type-certificate, supplemental type-certificate, ETSO authorisation, design change or repair approval, certificate of airworthiness, noise certificate, permit to fly, design organisation approval, production organisation approval certificate or letter of agreement under this Regulation, shall:

(a)

grant the competent authority access to any facility, product, part and appliance, document, record, data, process, procedure or to any other material in order to review any report, make any inspection, or perform or witness any flight and ground test, as necessary, in order to verify the initial and continued compliance of the organisation with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts.;

| (b) | make arrangements to ensure the competent authority has access, as provided for in point (a), also in respect of the natural or legal person’s partners, suppliers and subcontractors.’; |
| --- | --- |

(b)

make arrangements to ensure the competent authority has access, as provided for in point (a), also in respect of the natural or legal person’s partners, suppliers and subcontractors.’;

| (6) | in point 21.A.44, point (a) is replaced by the following:






  ‘(a) | undertake the obligations laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.9, 21.A.62 and 21.A.65, and, for this purpose, shall continue to meet the qualification requirements for eligibility under point 21.A.13;’; |
| --- | --- | --- |

(6)

in point 21.A.44, point (a) is replaced by the following:

‘(a)

undertake the obligations laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.9, 21.A.62 and 21.A.65, and, for this purpose, shall continue to meet the qualification requirements for eligibility under point 21.A.13;’;

| (7) | point 21.A.47 is replaced by the following:
  ‘21.A.47   Transferability

  The transfer of a type-certificate or a restricted type-certificate or an ETSO authorisation for an auxiliary power unit may only be made to a natural or legal person that is able to undertake the obligations laid down in point 21.A.44, and, for this purpose, has demonstrated its capability in accordance with point 21.A.14.’; |
| --- | --- |

(7)

point 21.A.47 is replaced by the following:

‘21.A.47   Transferability

The transfer of a type-certificate or a restricted type-certificate or an ETSO authorisation for an auxiliary power unit may only be made to a natural or legal person that is able to undertake the obligations laid down in point 21.A.44, and, for this purpose, has demonstrated its capability in accordance with point 21.A.14.’;

| (8) | in point 21.A.109, point (a) is replaced by the following:






  ‘(a) | undertake the obligations laid down in points 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.9 and 21.A.108;’; |
| --- | --- | --- |

(8)

in point 21.A.109, point (a) is replaced by the following:

‘(a)

undertake the obligations laid down in points 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.9 and 21.A.108;’;

| (9) | in point 21.A.118A(a), point (1) is replaced by the following:






  ‘1. | laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.9 and 21.A.120B;’; |
| --- | --- | --- |

(9)

in point 21.A.118A(a), point (1) is replaced by the following:

‘1.

laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.9 and 21.A.120B;’;

| (10) | the following point 21.A.124A is inserted:
  ‘21.A.124A   Means of compliance







  (a) | An organisation may use any alternative means of compliance to establish compliance with this Regulation. |
| --- | --- | --- |

(10)

the following point 21.A.124A is inserted:

‘21.A.124A   Means of compliance

(a)

An organisation may use any alternative means of compliance to establish compliance with this Regulation.

| (b) | If an organisation wishes to use an alternative means of compliance, it shall, prior to using it, provide the competent authority with a full description. The description shall include any revisions to manuals or procedures that may be relevant, as well as an explanation indicating how compliance with this Regulation is achieved.
  The organisation may use those alternative means of compliance subject to prior approval from the competent authority.’; |
| --- | --- |

(b)

If an organisation wishes to use an alternative means of compliance, it shall, prior to using it, provide the competent authority with a full description. The description shall include any revisions to manuals or procedures that may be relevant, as well as an explanation indicating how compliance with this Regulation is achieved.

The organisation may use those alternative means of compliance subject to prior approval from the competent authority.’;

| (11) | in point 21.A.125A, the title is replaced by the following:






  ‘21.A.125A | Issuance of a letter of agreement’ |
| --- | --- | --- |

(11)

in point 21.A.125A, the title is replaced by the following:

‘21.A.125A

| (12) | point 21.A.125B is replaced by the following:
  ‘21.A.125B   Findings and observations







  (a) | After receipt of the notification of findings in accordance with point 21.B.125, the holder of a letter of agreement shall:






  1. | identify the root cause(s) of, and contributing factor(s) to, the non-compliance; |
| --- | --- | --- | --- |

(12)

point 21.A.125B is replaced by the following:

‘21.A.125B   Findings and observations

(a)

After receipt of the notification of findings in accordance with point 21.B.125, the holder of a letter of agreement shall:

1.

identify the root cause(s) of, and contributing factor(s) to, the non-compliance;

| 2. | define a corrective action plan; |
| --- | --- |

2.

define a corrective action plan;

| 3. | demonstrate the implementation of the corrective action to the satisfaction of the competent authority. |
| --- | --- |

3.

demonstrate the implementation of the corrective action to the satisfaction of the competent authority.

| (b) | The actions referred to in point (a) shall be performed within the period agreed with that competent authority in accordance with point 21.B.125. |
| --- | --- |

(b)

The actions referred to in point (a) shall be performed within the period agreed with that competent authority in accordance with point 21.B.125.

| (c) | The observations received in accordance with point 21.B.125(e) shall be given due consideration by the holder of the letter of agreement. The organisation shall record the decisions taken in respect of those observations.’; |
| --- | --- |

(c)

The observations received in accordance with point 21.B.125(e) shall be given due consideration by the holder of the letter of agreement. The organisation shall record the decisions taken in respect of those observations.’;

| (13) | point 21.A.125C is replaced by the following:
  ‘21.A.125C   Duration and continued validity







  (a) | The letter of agreement shall be issued for a limited period of time that in any case shall not exceed 1 year. It shall remain valid subject to the organisation’s compliance with all the following conditions:






  1. | the production organisation continues to comply with the applicable requirements of this Annex; |
| --- | --- | --- | --- |

(13)

point 21.A.125C is replaced by the following:

‘21.A.125C   Duration and continued validity

(a)

The letter of agreement shall be issued for a limited period of time that in any case shall not exceed 1 year. It shall remain valid subject to the organisation’s compliance with all the following conditions:

1.

the production organisation continues to comply with the applicable requirements of this Annex;

| 2. | the production organisation or any of its partners, suppliers or subcontractors acknowledges that the competent authority may carry out investigations in accordance with point 21.A.9; |
| --- | --- |

2.

the production organisation or any of its partners, suppliers or subcontractors acknowledges that the competent authority may carry out investigations in accordance with point 21.A.9;

| 3. | the production organisation is able to provide the competent authority with evidence showing that it maintains satisfactory control of the manufacture of products, parts and appliances under the letter of agreement; |
| --- | --- |

3.

the production organisation is able to provide the competent authority with evidence showing that it maintains satisfactory control of the manufacture of products, parts and appliances under the letter of agreement;

| 4. | the letter of agreement has not been revoked by the competent authority under point 21.B.65, has not been surrendered by the production organisation, and its duration has not expired. |
| --- | --- |

4.

the letter of agreement has not been revoked by the competent authority under point 21.B.65, has not been surrendered by the production organisation, and its duration has not expired.

| (b) | Upon surrender, revocation or expiry, the letter of agreement shall be returned to the competent authority.’; |
| --- | --- |

(b)

Upon surrender, revocation or expiry, the letter of agreement shall be returned to the competent authority.’;

| (14) | point 21.A.126(b) is amended as follows:






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






  ‘5. | materials and parts that are withheld because of deviations from type design or production specifications, and that are to be considered for installation in the finished product, are subjected to an approved engineering and manufacturing review procedure. Those materials and parts that have been found in that procedure to be serviceable shall be properly identified and reinspected if it is necessary to be reworked or repaired. Materials and parts rejected in that procedure shall be marked and disposed of to ensure that they are not incorporated in the final product.’; |
| --- | --- | --- | --- |

(14)

point 21.A.126(b) is amended as follows:

(a)

point (5) is replaced by the following:

‘5.

materials and parts that are withheld because of deviations from type design or production specifications, and that are to be considered for installation in the finished product, are subjected to an approved engineering and manufacturing review procedure. Those materials and parts that have been found in that procedure to be serviceable shall be properly identified and reinspected if it is necessary to be reworked or repaired. Materials and parts rejected in that procedure shall be marked and disposed of to ensure that they are not incorporated in the final product.’;

| (b) | point (6) is deleted; |
| --- | --- |

(b)

point (6) is deleted;

| (15) | point 21.A.129 is amended as follows:






  (a) | the title is replaced by the following:






  ‘21.A.129 | Obligations of the production organisation’; |
| --- | --- | --- | --- |

(15)

point 21.A.129 is amended as follows:

(a)

the title is replaced by the following:

‘21.A.129

| (b) | point (e) is replaced by the following:






  ‘(e) | comply with Subpart A of this Section.’; |
| --- | --- | --- |

(b)

point (e) is replaced by the following:

‘(e)

comply with Subpart A of this Section.’;

| (c) | point (f) is deleted; |
| --- | --- |

(c)

point (f) is deleted;

| (16) | the following point 21.A.134A is inserted:
  ‘21.A.134A   Means of compliance







  (a) | An organisation may use any alternative means of compliance to establish compliance with this Regulation. |
| --- | --- | --- |

(16)

the following point 21.A.134A is inserted:

‘21.A.134A   Means of compliance

(a)

An organisation may use any alternative means of compliance to establish compliance with this Regulation.

| (b) | If an organisation wishes to use an alternative means of compliance, it shall, prior to using it, provide the competent authority with a full description. The description shall include any revisions to manuals or procedures that may be relevant, as well as an explanation indicating how compliance with this Regulation is achieved.
  The organisation may use those alternative means of compliance subject to prior approval from the competent authority..’; |
| --- | --- |

(b)

If an organisation wishes to use an alternative means of compliance, it shall, prior to using it, provide the competent authority with a full description. The description shall include any revisions to manuals or procedures that may be relevant, as well as an explanation indicating how compliance with this Regulation is achieved.

The organisation may use those alternative means of compliance subject to prior approval from the competent authority..’;

| (17) | in point 21.A.135, the title is replaced by the following:






  ‘21.A.135 | Issuance of production organisation approval’ |
| --- | --- | --- |

(17)

in point 21.A.135, the title is replaced by the following:

‘21.A.135

| (18) | point 21.A.139 is replaced by the following:
  ‘21.A.139   Production management system







  (a) | The production organisation shall establish, implement and maintain a production management system that includes a safety management element and a quality management element, with clearly defined accountability and lines of responsibility throughout the organisation. |
| --- | --- | --- |

(18)

point 21.A.139 is replaced by the following:

‘21.A.139   Production management system

(a)

The production organisation shall establish, implement and maintain a production management system that includes a safety management element and a quality management element, with clearly defined accountability and lines of responsibility throughout the organisation.

| (b) | The production management system shall:






  1. | correspond to the size of the organisation, and to the nature and complexity of its activities, taking into account the hazards and associated risks inherent in those activities; |
| --- | --- | --- |

(b)

The production management system shall:

1.

correspond to the size of the organisation, and to the nature and complexity of its activities, taking into account the hazards and associated risks inherent in those activities;

| 2. | be established, implemented and maintained under the direct accountability of a single manager appointed pursuant to point 21.A.145(c)(1). |
| --- | --- |

2.

be established, implemented and maintained under the direct accountability of a single manager appointed pursuant to point 21.A.145(c)(1).

| (c) | As part of the safety management element of the production management system, the production organisation shall:






  1. | establish, implement and maintain a safety policy and the corresponding related safety objectives; |
| --- | --- | --- |

(c)

As part of the safety management element of the production management system, the production organisation shall:

1.

establish, implement and maintain a safety policy and the corresponding related safety objectives;

| 2. | appoint key safety personnel in accordance with point 21.A.145(c)(2); |
| --- | --- |

2.

appoint key safety personnel in accordance with point 21.A.145(c)(2);

| 3. | establish, implement and maintain a safety risk management process to identify safety hazards entailed by its aviation activities, evaluate them and manage associated risks, including taking actions to mitigate the risks and verify their effectiveness; |
| --- | --- |

3.

establish, implement and maintain a safety risk management process to identify safety hazards entailed by its aviation activities, evaluate them and manage associated risks, including taking actions to mitigate the risks and verify their effectiveness;

| 4. | establish, implement and maintain a safety assurance process that includes:






  (i) | the measurement and monitoring of the organisation’s safety performance; |
| --- | --- | --- |

4.

establish, implement and maintain a safety assurance process that includes:

(i)

the measurement and monitoring of the organisation’s safety performance;

| (ii) | the management of changes in accordance with point 21.A.147; |
| --- | --- |

(ii)

the management of changes in accordance with point 21.A.147;

| (iii) | the principles for the continuous improvement of the safety management element; |
| --- | --- |

(iii)

the principles for the continuous improvement of the safety management element;

| 5. | promote safety in the organisation through:






  (i) | training and education; |
| --- | --- | --- |

5.

promote safety in the organisation through:

(i)

training and education;

| (ii) | communication; |
| --- | --- |

(ii)

communication;

| 6. | establish an occurrence reporting system in accordance with point 21.A.3A in order to contribute to the continuous improvement of safety. |
| --- | --- |

6.

establish an occurrence reporting system in accordance with point 21.A.3A in order to contribute to the continuous improvement of safety.

| (d) | As part of the quality management element of the production management system, the production organisation shall:






  1. | ensure that each product, part or appliance produced by the organisation or by its partners, or supplied from or subcontracted to outside parties, conforms to the applicable design data and is in condition for safe operation, thus enabling the exercise of the privileges set out in point 21.A.163; |
| --- | --- | --- |

(d)

As part of the quality management element of the production management system, the production organisation shall:

1.

ensure that each product, part or appliance produced by the organisation or by its partners, or supplied from or subcontracted to outside parties, conforms to the applicable design data and is in condition for safe operation, thus enabling the exercise of the privileges set out in point 21.A.163;

| 2. | establish, implement and maintain, as appropriate, within the scope of the approval, control procedures for:






  (i) | document issue, approval or change; |
| --- | --- | --- |

2.

establish, implement and maintain, as appropriate, within the scope of the approval, control procedures for:

(i)

document issue, approval or change;

| (ii) | vendor and subcontractor assessment audit and control; |
| --- | --- |

(ii)

vendor and subcontractor assessment audit and control;

| (iii) | verifying that incoming products, parts, materials and equipment, including items supplied new or used by buyers of products, are as specified in the applicable design data; |
| --- | --- |

(iii)

verifying that incoming products, parts, materials and equipment, including items supplied new or used by buyers of products, are as specified in the applicable design data;

| (iv) | identification and traceability; |
| --- | --- |

(iv)

identification and traceability;

| (v) | manufacturing processes; |
| --- | --- |

(v)

manufacturing processes;

| (vi) | inspection and testing, including production flight tests; |
| --- | --- |

(vi)

inspection and testing, including production flight tests;

| (vii) | the calibration of tools, jigs, and test equipment; |
| --- | --- |

(vii)

the calibration of tools, jigs, and test equipment;

| (viii) | non-conforming item control; |
| --- | --- |

(viii)

non-conforming item control;

| (ix) | airworthiness coordination with the applicant for, or holder of, the design approval; |
| --- | --- |

(ix)

airworthiness coordination with the applicant for, or holder of, the design approval;

| (x) | the completion and retention of records; |
| --- | --- |

(x)

the completion and retention of records;

| (xi) | the competence and qualifications of personnel; |
| --- | --- |

(xi)

the competence and qualifications of personnel;

| (xii) | the issue of airworthiness release documents; |
| --- | --- |

(xii)

the issue of airworthiness release documents;

| (xiii) | handling, storage and packing; |
| --- | --- |

(xiii)

handling, storage and packing;

| (xiv) | internal quality audits and the resulting corrective actions; |
| --- | --- |

(xiv)

internal quality audits and the resulting corrective actions;

| (xv) | work within the terms of approval performed at any location other than the approved facilities; |
| --- | --- |

(xv)

work within the terms of approval performed at any location other than the approved facilities;

| (xvi) | work performed after the completion of production but prior to delivery, to maintain the aircraft in a condition for safe operation; |
| --- | --- |

(xvi)

work performed after the completion of production but prior to delivery, to maintain the aircraft in a condition for safe operation;

| (xvii) | the issue of a permit to fly and approval of the associated flight conditions; |
| --- | --- |

(xvii)

the issue of a permit to fly and approval of the associated flight conditions;

| 3. | include specific provisions in the control procedures for any critical parts. |
| --- | --- |

3.

include specific provisions in the control procedures for any critical parts.

| (e) | The production organisation shall establish, as part of the production management system, an independent monitoring function to verify compliance of the organisation with the relevant requirements of this Annex as well as compliance with and adequacy of the production management system. Monitoring shall include feedback to the person or group of persons referred to in point 21.A.145(c)(2) and to the manager referred to in point 21.A.145(c)(1) to ensure, where necessary, the implementation of corrective action. |
| --- | --- |

(e)

The production organisation shall establish, as part of the production management system, an independent monitoring function to verify compliance of the organisation with the relevant requirements of this Annex as well as compliance with and adequacy of the production management system. Monitoring shall include feedback to the person or group of persons referred to in point 21.A.145(c)(2) and to the manager referred to in point 21.A.145(c)(1) to ensure, where necessary, the implementation of corrective action.

| (f) | If the production organisation holds one or more additional organisation certificates within the scope of Regulation (EU) 2018/1139, the production management system may be integrated with that required under the additional certificate(s) held.’; |
| --- | --- |

(f)

If the production organisation holds one or more additional organisation certificates within the scope of Regulation (EU) 2018/1139, the production management system may be integrated with that required under the additional certificate(s) held.’;

| (19) | point 21.A.143 is amended as follows:






  (a) | the title is replaced by the following:






  ‘21.A.143 | Production organisation exposition’; |
| --- | --- | --- | --- |

(19)

point 21.A.143 is amended as follows:

(a)

the title is replaced by the following:

‘21.A.143

| (b) | point (a) is amended as follows:






  (i) | the introductory phrase is replaced by the following:






  ‘(a) | The production organisation shall establish and maintain a production organisation exposition (POE) that provides directly or by cross reference the following information related to the production management system as described in point 21.A.139:’; |
| --- | --- | --- | --- |

(b)

point (a) is amended as follows:

(i)

the introductory phrase is replaced by the following:

‘(a)

The production organisation shall establish and maintain a production organisation exposition (POE) that provides directly or by cross reference the following information related to the production management system as described in point 21.A.139:’;

| (ii) | point (11) is replaced by the following:






  ‘11. | a description of the production management system, the policy, processes and procedures as provided for in point 21.A.139(c);’; |
| --- | --- | --- |

(ii)

point (11) is replaced by the following:

‘11.

a description of the production management system, the policy, processes and procedures as provided for in point 21.A.139(c);’;

| (iii) | point (12) is replaced by the following:






  ‘12. | a list of the outside parties referred to in point 21.A.139(d)(1);’; |
| --- | --- | --- |

(iii)

point (12) is replaced by the following:

‘12.

a list of the outside parties referred to in point 21.A.139(d)(1);’;

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






  ‘(b) | The initial issue of the POE shall be approved by the competent authority.’; |
| --- | --- | --- |

(c)

point (b) is replaced by the following:

‘(b)

The initial issue of the POE shall be approved by the competent authority.’;

| (d) | the following point (c) is added:






  ‘(c) | The POE shall be amended as necessary so that it remains an up-to-date description of the organisation. Copies of any amendments shall be supplied to the competent authority.’; |
| --- | --- | --- |

(d)

the following point (c) is added:

‘(c)

The POE shall be amended as necessary so that it remains an up-to-date description of the organisation. Copies of any amendments shall be supplied to the competent authority.’;

| (20) | point 21.A.145 is replaced by the following:
  ‘21.A.145   Resources

  The production organisation shall demonstrate that:






  (a) | the facilities, working conditions, equipment and tools, processes and associated materials, number and competence of staff, and the general organisation are adequate to discharge its obligations under point 21.A.165; |
| --- | --- | --- |

(20)

point 21.A.145 is replaced by the following:

‘21.A.145   Resources

The production organisation shall demonstrate that:

(a)

the facilities, working conditions, equipment and tools, processes and associated materials, number and competence of staff, and the general organisation are adequate to discharge its obligations under point 21.A.165;

| (b) | with regard to all the necessary airworthiness and environmental protection data:






  1. | the production organisation holds all data it needs to determine conformity with the applicable design data. Such data may originate from the Agency and from the holder of, or applicant for, the type-certificate, restricted type-certificate or design approval, and may include any exemption granted from the environmental protection requirements; |
| --- | --- | --- |

(b)

with regard to all the necessary airworthiness and environmental protection data:

1.

the production organisation holds all data it needs to determine conformity with the applicable design data. Such data may originate from the Agency and from the holder of, or applicant for, the type-certificate, restricted type-certificate or design approval, and may include any exemption granted from the environmental protection requirements;

| 2. | the production organisation has established a procedure to ensure that the airworthiness and environmental protection data are correctly incorporated in its production data; |
| --- | --- |

2.

the production organisation has established a procedure to ensure that the airworthiness and environmental protection data are correctly incorporated in its production data;

| 3. | such data are kept up to date and made available to all personnel that need access to such data to perform their duties; |
| --- | --- |

3.

such data are kept up to date and made available to all personnel that need access to such data to perform their duties;

| (c) | with regard to management and staff:






  1. | an accountable manager has been appointed by the production organisation with the authority to ensure that, within the organisation, all production is performed to the required standards and that the production organisation is continuously in compliance with the requirements of the production management system referred to in point 21.A.139, and the data and procedures identified in the POE referred to in point 21.A.143; |
| --- | --- | --- |

(c)

with regard to management and staff:

1.

an accountable manager has been appointed by the production organisation with the authority to ensure that, within the organisation, all production is performed to the required standards and that the production organisation is continuously in compliance with the requirements of the production management system referred to in point 21.A.139, and the data and procedures identified in the POE referred to in point 21.A.143;

| 2. | a person or group of persons has/have been nominated by the accountable manager to ensure that the organisation is in compliance with the requirements of this Annex, and are identified, together with the extent of their authority; such person or group of persons shall be responsible to the accountable manager and have direct access to him. The person or group of persons shall have the appropriate knowledge, background and experience to discharge their responsibilities; |
| --- | --- |

2.

a person or group of persons has/have been nominated by the accountable manager to ensure that the organisation is in compliance with the requirements of this Annex, and are identified, together with the extent of their authority; such person or group of persons shall be responsible to the accountable manager and have direct access to him. The person or group of persons shall have the appropriate knowledge, background and experience to discharge their responsibilities;

| 3. | staff at all levels have been given the appropriate authority to be able to discharge their allocated responsibilities and that there is full and effective coordination within the production organisation in respect of airworthiness and environmental protection data matters; |
| --- | --- |

3.

staff at all levels have been given the appropriate authority to be able to discharge their allocated responsibilities and that there is full and effective coordination within the production organisation in respect of airworthiness and environmental protection data matters;

| (d) | with regard to certifying staff authorised by the production organisation to sign the documents issued under point 21.A.163 within the scope of the terms of approval:






  1. | they have the appropriate knowledge, background (including other functions in the organisation) and experience to discharge their allocated responsibilities; |
| --- | --- | --- |

(d)

with regard to certifying staff authorised by the production organisation to sign the documents issued under point 21.A.163 within the scope of the terms of approval:

1.

they have the appropriate knowledge, background (including other functions in the organisation) and experience to discharge their allocated responsibilities;

| 2. | they are provided with evidence of the scope of their authorisation.’; |
| --- | --- |

2.

they are provided with evidence of the scope of their authorisation.’;

| (21) | point 21.A.147 is replaced by the following:
  ‘21.A.147   Changes in the production management system

  After the issue of a production organisation approval certificate, each change in the production management system that is significant for the demonstration of conformity or the airworthiness and environmental protection characteristics of the product, part or appliance, shall be approved by the competent authority before being implemented. The production organisation shall submit an application for approval to the competent authority demonstrating that it will continue to comply with this Annex.’; |
| --- | --- |

(21)

point 21.A.147 is replaced by the following:

‘21.A.147   Changes in the production management system

After the issue of a production organisation approval certificate, each change in the production management system that is significant for the demonstration of conformity or the airworthiness and environmental protection characteristics of the product, part or appliance, shall be approved by the competent authority before being implemented. The production organisation shall submit an application for approval to the competent authority demonstrating that it will continue to comply with this Annex.’;

| (22) | point 21.A.157 is deleted; |
| --- | --- |

(22)

point 21.A.157 is deleted;

| (23) | point 21.A.158 is replaced by the following:
  ‘21.A.158   Findings and observations







  (a) | After receipt of the notification of findings in accordance with point 21.B.225, the holder of the production organisation approval certificate shall:






  1. | identify the root cause(s) of, and contributing factor(s) to, the non-compliance; |
| --- | --- | --- | --- |

(23)

point 21.A.158 is replaced by the following:

‘21.A.158   Findings and observations

(a)

After receipt of the notification of findings in accordance with point 21.B.225, the holder of the production organisation approval certificate shall:

1.

identify the root cause(s) of, and contributing factor(s) to, the non-compliance;

| 2. | define a corrective action plan; |
| --- | --- |

2.

define a corrective action plan;

| 3. | demonstrate the implementation of the corrective action to the satisfaction of the competent authority. |
| --- | --- |

3.

demonstrate the implementation of the corrective action to the satisfaction of the competent authority.

| (b) | The actions referred to in point (a) shall be performed within the period agreed with that competent authority in accordance with point 21.B.225. |
| --- | --- |

(b)

The actions referred to in point (a) shall be performed within the period agreed with that competent authority in accordance with point 21.B.225.

| (c) | The observations received in accordance with 21.B.225(e) shall be given due consideration by the holder of the production organisation approval certificate. The organisation shall record the decisions taken in respect of those observations.’; |
| --- | --- |

(c)

The observations received in accordance with 21.B.225(e) shall be given due consideration by the holder of the production organisation approval certificate. The organisation shall record the decisions taken in respect of those observations.’;

| (24) | point 21.A.159 is replaced by the following:
  ‘21.A.159   Duration and continued validity







  (a) | A production organisation approval certificate shall be issued for an unlimited period of time. It shall remain valid subject to the production organisation’s compliance with all the following conditions:






  1. | the production organisation continues to comply with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts; |
| --- | --- | --- | --- |

(24)

point 21.A.159 is replaced by the following:

‘21.A.159   Duration and continued validity

(a)

A production organisation approval certificate shall be issued for an unlimited period of time. It shall remain valid subject to the production organisation’s compliance with all the following conditions:

1.

the production organisation continues to comply with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts;

| 2. | the competent authority is permitted by the production organisation or by any of its partners, suppliers or subcontractors to perform the investigations in accordance with point 21.A.9; |
| --- | --- |

2.

the competent authority is permitted by the production organisation or by any of its partners, suppliers or subcontractors to perform the investigations in accordance with point 21.A.9;

| 3. | the production organisation is able to provide the competent authority with evidence showing that it maintains satisfactory control of the manufacture of products, parts and appliances under the approval; |
| --- | --- |

3.

the production organisation is able to provide the competent authority with evidence showing that it maintains satisfactory control of the manufacture of products, parts and appliances under the approval;

| 4. | the production organisation approval certificate has not been revoked by the competent authority under point 21.B.65, or surrendered by the production organisation. |
| --- | --- |

4.

the production organisation approval certificate has not been revoked by the competent authority under point 21.B.65, or surrendered by the production organisation.

| (b) | Upon surrender or revocation, the production organisation approval certificate shall be returned to the competent authority.’; |
| --- | --- |

(b)

Upon surrender or revocation, the production organisation approval certificate shall be returned to the competent authority.’;

| (25) | point 21.A.165 is amended as follows:






  (a) | points (d) to (h) are replaced by the following:






  ‘(d) | provide assistance to the holder of the type-certificate or other design approval in dealing with any continuing airworthiness actions that are related to the products, parts or appliances that have been produced; |
| --- | --- | --- | --- |

(25)

point 21.A.165 is amended as follows:

(a)

points (d) to (h) are replaced by the following:

‘(d)

provide assistance to the holder of the type-certificate or other design approval in dealing with any continuing airworthiness actions that are related to the products, parts or appliances that have been produced;

| (e) | where, under its terms of approval, the holder of a production organisation approval intends to issue a certificate of release to service, determine, prior to issuing the certificate, that each completed aircraft has been subjected to necessary maintenance and is in condition for safe operation; |
| --- | --- |

(e)

where, under its terms of approval, the holder of a production organisation approval intends to issue a certificate of release to service, determine, prior to issuing the certificate, that each completed aircraft has been subjected to necessary maintenance and is in condition for safe operation;

| (f) | where applicable, under the privilege set out in point 21.A.163(e), determine the conditions under which a permit to fly can be issued; |
| --- | --- |

(f)

where applicable, under the privilege set out in point 21.A.163(e), determine the conditions under which a permit to fly can be issued;

| (g) | where applicable, under the privilege set out in point 21.A.163(e), establish compliance with points 21.A.711(c) and (e) before issuing an aircraft with a permit to fly; |
| --- | --- |

(g)

where applicable, under the privilege set out in point 21.A.163(e), establish compliance with points 21.A.711(c) and (e) before issuing an aircraft with a permit to fly;

| (h) | comply with Subpart A of this Section.’; |
| --- | --- |

(h)

comply with Subpart A of this Section.’;

| (b) | points (i), (j) and (k) are deleted; |
| --- | --- |

(b)

points (i), (j) and (k) are deleted;

| (26) | point 21.A.180 is deleted; |
| --- | --- |

(26)

point 21.A.180 is deleted;

| (27) | point 21.A.181(a) is amended as follows:






  (a) | the introductory phrase is replaced by the following:






  ‘(a) | An airworthiness certificate shall be issued for an unlimited period of time. It shall remain valid subject to compliance with all the following conditions:’; |
| --- | --- | --- | --- |

(27)

point 21.A.181(a) is amended as follows:

(a)

the introductory phrase is replaced by the following:

‘(a)

An airworthiness certificate shall be issued for an unlimited period of time. It shall remain valid subject to compliance with all the following conditions:’;

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






  ‘1. | the aircraft continues to comply with the applicable type design and continued airworthiness requirements; and’; |
| --- | --- | --- |

(b)

point (1) is replaced by the following:

‘1.

the aircraft continues to comply with the applicable type design and continued airworthiness requirements; and’;

| (c) | point (4) is replaced by the following:






  ‘4. | the certificate has not been revoked by the competent authority under point 21.B.65, or surrendered by the certificate holder.’; |
| --- | --- | --- |

(c)

point (4) is replaced by the following:

‘4.

the certificate has not been revoked by the competent authority under point 21.B.65, or surrendered by the certificate holder.’;

| (28) | point 21.A.210 is deleted; |
| --- | --- |

(28)

point 21.A.210 is deleted;

| (29) | point 21.A.211(a) is amended as follows:






  (a) | the introductory phrase is replaced by the following:






  ‘(a) | A noise certificate shall be issued for an unlimited period of time. It shall remain valid subject to compliance with all the following conditions:’; |
| --- | --- | --- | --- |

(29)

point 21.A.211(a) is amended as follows:

(a)

the introductory phrase is replaced by the following:

‘(a)

A noise certificate shall be issued for an unlimited period of time. It shall remain valid subject to compliance with all the following conditions:’;

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






  ‘1. | the aircraft continues to comply with the applicable type design and continued airworthiness requirements; and’; |
| --- | --- | --- |

(b)

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

‘1.

the aircraft continues to comply with the applicable type design and continued airworthiness requirements; and’;

| (c) | point (4) is replaced by the following:






  ‘(4) | the certificate has not been revoked by the competent authority under point 21.B.65, or surrendered by the certificate holder.’; |
| --- | --- | --- |

(c)

point (4) is replaced by the following:

‘(4)

the certificate has not been revoked by the competent authority under point 21.B.65, or surrendered by the certificate holder.’;

| (30) | point 21.A.239 is replaced by the following:
  ‘21.A.239   Design management system







  (a) | The design organisation shall establish, implement and maintain a design management system that includes a safety management element and a design assurance element with clearly defined accountability and lines of responsibility throughout the organisation. |
| --- | --- | --- |

(30)

point 21.A.239 is replaced by the following:

‘21.A.239   Design management system

(a)

The design organisation shall establish, implement and maintain a design management system that includes a safety management element and a design assurance element with clearly defined accountability and lines of responsibility throughout the organisation.

| (b) | The design management system shall:






  1. | correspond to the size of the organisation and to the nature and complexity of its activities, taking into account the hazards and associated risks inherent in those activities; |
| --- | --- | --- |

(b)

The design management system shall:

1.

correspond to the size of the organisation and to the nature and complexity of its activities, taking into account the hazards and associated risks inherent in those activities;

| 2. | be established, implemented and maintained under the accountability of a single manager appointed pursuant to point 21.A.245(a). |
| --- | --- |

2.

be established, implemented and maintained under the accountability of a single manager appointed pursuant to point 21.A.245(a).

| (c) | As part of the safety management element of the design management system, the design organisation shall:






  1. | establish, implement and maintain a safety policy and the corresponding related safety objectives; |
| --- | --- | --- |

(c)

As part of the safety management element of the design management system, the design organisation shall:

1.

establish, implement and maintain a safety policy and the corresponding related safety objectives;

| 2. | appoint key safety personnel in accordance with point 21.A.245(b); |
| --- | --- |

2.

appoint key safety personnel in accordance with point 21.A.245(b);

| 3. | establish, implement and maintain a safety risk management process that includes the identification of aviation safety hazards entailed by its activities, their evaluation and the management of the associated risks, including taking actions to mitigate the risks and verify their effectiveness; |
| --- | --- |

3.

establish, implement and maintain a safety risk management process that includes the identification of aviation safety hazards entailed by its activities, their evaluation and the management of the associated risks, including taking actions to mitigate the risks and verify their effectiveness;

| 4. | establish, implement and maintain a safety assurance process that includes:






  (i) | the measurement and monitoring of the organisation’s safety performance; |
| --- | --- | --- |

4.

establish, implement and maintain a safety assurance process that includes:

(i)

the measurement and monitoring of the organisation’s safety performance;

| (ii) | the management of changes in accordance with points 21.A.243(c) and 21.A.247; |
| --- | --- |

(ii)

the management of changes in accordance with points 21.A.243(c) and 21.A.247;

| (iii) | the principles for the continuous improvement of the safety management element; |
| --- | --- |

(iii)

the principles for the continuous improvement of the safety management element;

| 5. | promote safety in the organisation through:






  (i) | training and education; |
| --- | --- | --- |

5.

promote safety in the organisation through:

(i)

training and education;

| (ii) | communication; |
| --- | --- |

(ii)

communication;

| 6. | establish an occurrence reporting system in accordance with point 21.A.3A in order to contribute to continuous improvement of safety. |
| --- | --- |

6.

establish an occurrence reporting system in accordance with point 21.A.3A in order to contribute to continuous improvement of safety.

| (d) | As part of the design assurance element of the design management system, the design organisation shall:






  1. | establish, implement and maintain a system for the control and supervision of the design, and of design changes and repairs, of products, parts and appliances covered by the terms of approval; that system shall:






  (i) | include an airworthiness function responsible for ensuring that the design of products, parts and appliances, or the design changes and repairs, comply with the applicable type-certification basis, the applicable operational suitability data certification basis and the environmental protection requirements; |
| --- | --- | --- | --- |

(d)

As part of the design assurance element of the design management system, the design organisation shall:

1.

establish, implement and maintain a system for the control and supervision of the design, and of design changes and repairs, of products, parts and appliances covered by the terms of approval; that system shall:

(i)

include an airworthiness function responsible for ensuring that the design of products, parts and appliances, or the design changes and repairs, comply with the applicable type-certification basis, the applicable operational suitability data certification basis and the environmental protection requirements;

| (ii) | ensure that the design organisation properly discharges its responsibilities in accordance with this Annex and with the terms of approval issued under point 21.A.251; |
| --- | --- |

(ii)

ensure that the design organisation properly discharges its responsibilities in accordance with this Annex and with the terms of approval issued under point 21.A.251;

| 2. | establish, implement and maintain an independent verification function on the basis of which the design organisation demonstrates compliance with the applicable airworthiness, operational suitability data and environmental protection requirements; |
| --- | --- |

2.

establish, implement and maintain an independent verification function on the basis of which the design organisation demonstrates compliance with the applicable airworthiness, operational suitability data and environmental protection requirements;

| 3. | specify the manner in which the design management system accounts for the acceptability of the parts or appliances that are designed or the tasks that are performed by its partners or subcontractors according to the methods which are the subject of written procedures. |
| --- | --- |

3.

specify the manner in which the design management system accounts for the acceptability of the parts or appliances that are designed or the tasks that are performed by its partners or subcontractors according to the methods which are the subject of written procedures.

| (e) | The design organisation shall establish, as part of the design management system, an independent monitoring function to verify compliance of the organisation with the relevant requirements of this Annex as well as the compliance with and adequacy of the design management system. Monitoring shall include feedback to the person or the group of persons referred to in point 21.A.245(b) and to the manager referred to in point 21.A.245(a) to ensure, where necessary, the implementation of corrective action. |
| --- | --- |

(e)

The design organisation shall establish, as part of the design management system, an independent monitoring function to verify compliance of the organisation with the relevant requirements of this Annex as well as the compliance with and adequacy of the design management system. Monitoring shall include feedback to the person or the group of persons referred to in point 21.A.245(b) and to the manager referred to in point 21.A.245(a) to ensure, where necessary, the implementation of corrective action.

| (f) | If the design organisation holds one or more additional organisation certificates within the scope of Regulation (EU) 2018/1139, the design management system may be integrated with that required under the additional certificate(s).’; |
| --- | --- |

(f)

If the design organisation holds one or more additional organisation certificates within the scope of Regulation (EU) 2018/1139, the design management system may be integrated with that required under the additional certificate(s).’;

| (31) | point 21.A.243 is replaced by the following:
  ‘21.A.243   Handbook







  (a) | As part of the design management system, the design organisation shall create and furnish to the Agency a handbook that describes, directly or by cross reference, the organisation, its relevant policies, processes and procedures, the type of design work, and the categories of products, parts and appliances for which the design organisation holds a design organisation approval, as identified in the terms of approval issued in accordance with point 21.A.251 and, where relevant, the interfaces with and the control of its partners or subcontractors.
  If flight tests are to be conducted, a flight test operations manual that defines the organisation’s policies and procedures in relation to flight tests shall also be created and furnished to the Agency. The flight test operations manual shall include:






  1. | a description of the organisation’s processes for flight tests, including its involvement in the process for issuing a permit to fly; |
| --- | --- | --- | --- |

(31)

point 21.A.243 is replaced by the following:

‘21.A.243   Handbook

(a)

As part of the design management system, the design organisation shall create and furnish to the Agency a handbook that describes, directly or by cross reference, the organisation, its relevant policies, processes and procedures, the type of design work, and the categories of products, parts and appliances for which the design organisation holds a design organisation approval, as identified in the terms of approval issued in accordance with point 21.A.251 and, where relevant, the interfaces with and the control of its partners or subcontractors.

If flight tests are to be conducted, a flight test operations manual that defines the organisation’s policies and procedures in relation to flight tests shall also be created and furnished to the Agency. The flight test operations manual shall include:

1.

a description of the organisation’s processes for flight tests, including its involvement in the process for issuing a permit to fly;

| 2. | crewing policy, including composition, competency, currency and flight time limitations, in accordance with Appendix XII, where applicable; |
| --- | --- |

2.

crewing policy, including composition, competency, currency and flight time limitations, in accordance with Appendix XII, where applicable;

| 3. | procedures for the carriage of persons other than the crew members and for flight test training, where applicable; |
| --- | --- |

3.

procedures for the carriage of persons other than the crew members and for flight test training, where applicable;

| 4. | a policy for the risk and safety management and associated methodologies; |
| --- | --- |

4.

a policy for the risk and safety management and associated methodologies;

| 5. | procedures to identify the instruments and equipment to be carried on board; |
| --- | --- |

5.

procedures to identify the instruments and equipment to be carried on board;

| 6. | a list of documents that need to be produced for the flight test. |
| --- | --- |

6.

a list of documents that need to be produced for the flight test.

| (b) | Where any parts or appliances or any changes to the products are designed by partner organisations or subcontractors, the handbook shall include a statement of how the design organisation is able to demonstrate, for all parts and appliances, the compliance in accordance with point 21.A.239(d)(2), and shall contain, directly or by cross reference, descriptions of and information on the design activities and the organisation of those partner organisations or subcontractors, as necessary to establish the statement. |
| --- | --- |

(b)

Where any parts or appliances or any changes to the products are designed by partner organisations or subcontractors, the handbook shall include a statement of how the design organisation is able to demonstrate, for all parts and appliances, the compliance in accordance with point 21.A.239(d)(2), and shall contain, directly or by cross reference, descriptions of and information on the design activities and the organisation of those partner organisations or subcontractors, as necessary to establish the statement.

| (c) | The handbook shall be amended as necessary to remain an up-to-date description of the organisation, and copies of the amendments shall be provided to the Agency. |
| --- | --- |

(c)

The handbook shall be amended as necessary to remain an up-to-date description of the organisation, and copies of the amendments shall be provided to the Agency.

| (d) | The design organisation shall establish and maintain a statement of the qualifications and experience of the management staff and of other persons in the organisation that are responsible for making decisions that affect airworthiness, operational suitability data and environmental protection matters. It shall submit that statement to the competent authority’; |
| --- | --- |

(d)

The design organisation shall establish and maintain a statement of the qualifications and experience of the management staff and of other persons in the organisation that are responsible for making decisions that affect airworthiness, operational suitability data and environmental protection matters. It shall submit that statement to the competent authority’;

| (32) | point 21.A.245 is replaced by the following:
  ‘21.A.245   Resources







  (a) | The organisation shall appoint a head of the design organisation with the authority to ensure that, within the organisation, all design activities are performed to the required standards and that the design organisation is continuously in compliance with the requirements of the design management system referred to in point 21.A.239 and the procedures specified in the handbook referred to in point 21.A.243. |
| --- | --- | --- |

(32)

point 21.A.245 is replaced by the following:

‘21.A.245   Resources

(a)

The organisation shall appoint a head of the design organisation with the authority to ensure that, within the organisation, all design activities are performed to the required standards and that the design organisation is continuously in compliance with the requirements of the design management system referred to in point 21.A.239 and the procedures specified in the handbook referred to in point 21.A.243.

| (b) | The head of the design organisation shall nominate and specify the extent of authority of:






  1. | a chief of the airworthiness function; |
| --- | --- | --- |

(b)

The head of the design organisation shall nominate and specify the extent of authority of:

1.

a chief of the airworthiness function;

| 2. | a chief of the independent monitoring function; |
| --- | --- |

2.

a chief of the independent monitoring function;

| 3. | depending on the size of the organisation and the nature and complexity of its activities, any other person or group of persons that are required to ensure that the organisation complies with the requirements of this Annex. |
| --- | --- |

3.

depending on the size of the organisation and the nature and complexity of its activities, any other person or group of persons that are required to ensure that the organisation complies with the requirements of this Annex.

| (c) | By way of derogation from point 21.A.245(b)(1), the airworthiness function referred to in point 21.A.239(d)(1)(i) may be performed under the direct supervision of the head of the design organisation in either of the following cases:






  1. | where the scope of activities of/of work of the design organisation, as identified in the terms of approval issued under point 21.A.251, is limited to minor changes and/or minor repairs; |
| --- | --- | --- |

(c)

By way of derogation from point 21.A.245(b)(1), the airworthiness function referred to in point 21.A.239(d)(1)(i) may be performed under the direct supervision of the head of the design organisation in either of the following cases:

1.

where the scope of activities of/of work of the design organisation, as identified in the terms of approval issued under point 21.A.251, is limited to minor changes and/or minor repairs;

| 2. | for a limited period of time when the design organisation does not have a nominated chief of the airworthiness function and the exercise of that function under the direct supervision of the head of the design organisation is commensurate with the scope and level of the organisation’s activities. |
| --- | --- |

2.

for a limited period of time when the design organisation does not have a nominated chief of the airworthiness function and the exercise of that function under the direct supervision of the head of the design organisation is commensurate with the scope and level of the organisation’s activities.

| (d) | The person or group of persons nominated pursuant to point (b) shall:






  1. | be answerable to the head of the design organisation and have direct access to them; |
| --- | --- | --- |

(d)

The person or group of persons nominated pursuant to point (b) shall:

1.

be answerable to the head of the design organisation and have direct access to them;

| 2. | have the appropriate knowledge, background and experience to discharge their responsibilities. |
| --- | --- |

2.

have the appropriate knowledge, background and experience to discharge their responsibilities.

| (e) | The design organisation shall ensure that:






  1. | the staff in all technical departments are of sufficient numbers and experience and have been given the appropriate authority to be able to discharge their allocated responsibilities and the facilities, equipment and accommodation that are adequate to enable the staff to fulfil the airworthiness, operational suitability data and environmental protection requirements as regards the product; |
| --- | --- | --- |

(e)

The design organisation shall ensure that:

1.

the staff in all technical departments are of sufficient numbers and experience and have been given the appropriate authority to be able to discharge their allocated responsibilities and the facilities, equipment and accommodation that are adequate to enable the staff to fulfil the airworthiness, operational suitability data and environmental protection requirements as regards the product;

| 2. | there is full and efficient coordination between the departments and within the departments in respect of airworthiness, operational suitability data and environmental protection matters.’; |
| --- | --- |

2.

there is full and efficient coordination between the departments and within the departments in respect of airworthiness, operational suitability data and environmental protection matters.’;

| (33) | point 21.A.247 is replaced by the following:
  ‘21.A.247   Changes in the design management system

  After the issue of a design organisation approval, each change to the design management system that is significant to the demonstration of compliance or to the airworthiness, operational suitability and environmental protection of the product, part or appliance shall be approved by the Agency before being implemented. The design organisation shall submit to the Agency an application for approval demonstrating, on the basis of the proposed changes to the handbook, that it will continue to comply with this Annex.’; |
| --- | --- |

(33)

point 21.A.247 is replaced by the following:

‘21.A.247   Changes in the design management system

After the issue of a design organisation approval, each change to the design management system that is significant to the demonstration of compliance or to the airworthiness, operational suitability and environmental protection of the product, part or appliance shall be approved by the Agency before being implemented. The design organisation shall submit to the Agency an application for approval demonstrating, on the basis of the proposed changes to the handbook, that it will continue to comply with this Annex.’;

| (34) | point 21.A.257 is deleted; |
| --- | --- |

(34)

point 21.A.257 is deleted;

| (35) | point 21.A.258 is replaced by the following:
  ‘21.A.258   Findings and observations







  (a) | After the receipt of the notification of findings in accordance with point 21.B.433, the holder of the design organisation approval shall:






  1. | identify the root cause(s) of, and contributing factor(s) to, the non-compliance; |
| --- | --- | --- | --- |

(35)

point 21.A.258 is replaced by the following:

‘21.A.258   Findings and observations

(a)

After the receipt of the notification of findings in accordance with point 21.B.433, the holder of the design organisation approval shall:

1.

identify the root cause(s) of, and contributing factor(s) to, the non-compliance;

| 2. | establish a corrective action plan; |
| --- | --- |

2.

establish a corrective action plan;

| 3. | demonstrate the implementation of the corrective action to the satisfaction of the Agency. |
| --- | --- |

3.

demonstrate the implementation of the corrective action to the satisfaction of the Agency.

| (b) | The actions referred to in point (a) shall be performed within the period agreed by the Agency in accordance with point 21.B.433. |
| --- | --- |

(b)

The actions referred to in point (a) shall be performed within the period agreed by the Agency in accordance with point 21.B.433.

| (c) | The observations received in accordance with point 21.B.433(e) shall be given due consideration by the holder of the design organisation approval. The organisation shall record the decisions taken in respect of those observations.’; |
| --- | --- |

(c)

The observations received in accordance with point 21.B.433(e) shall be given due consideration by the holder of the design organisation approval. The organisation shall record the decisions taken in respect of those observations.’;

| (36) | point 21.A.259 is replaced by the following:
  ‘21.A.259   Duration and continued validity







  (a) | A design organisation approval shall be issued for an unlimited period of time. It shall remain valid subject to the design organisation’s compliance with all the following conditions:






  1. | the design organisation continues to comply with Regulation (EU) 2018/1139 and its delegated and implementing acts; taking into account the provisions of point 21.B.433 of this Annex related to the handling of findings; |
| --- | --- | --- | --- |

(36)

point 21.A.259 is replaced by the following:

‘21.A.259   Duration and continued validity

(a)

A design organisation approval shall be issued for an unlimited period of time. It shall remain valid subject to the design organisation’s compliance with all the following conditions:

1.

the design organisation continues to comply with Regulation (EU) 2018/1139 and its delegated and implementing acts; taking into account the provisions of point 21.B.433 of this Annex related to the handling of findings;

| 2. | the holder of the design organisation approval or any of its partners or subcontractors acknowledge that the competent authority may carry out investigations in accordance with point 21.A.9; |
| --- | --- |

2.

the holder of the design organisation approval or any of its partners or subcontractors acknowledge that the competent authority may carry out investigations in accordance with point 21.A.9;

| 3. | the design organisation is able to provide the Agency with evidence showing that the design management system of the organisation maintains satisfactory control and supervision of the design of products, repairs and changes thereto under the approval; |
| --- | --- |

3.

the design organisation is able to provide the Agency with evidence showing that the design management system of the organisation maintains satisfactory control and supervision of the design of products, repairs and changes thereto under the approval;

| 4. | the certificate has not been revoked by the Agency under point 21.B.65, or surrendered by the design organisation. |
| --- | --- |

4.

the certificate has not been revoked by the Agency under point 21.B.65, or surrendered by the design organisation.

| (b) | Upon surrender or revocation, the certificate shall be returned to the Agency.’; |
| --- | --- |

(b)

Upon surrender or revocation, the certificate shall be returned to the Agency.’;

| (37) | in point 21.A.263(c), the introductory phrase is replaced by the following:






  ‘(c) | The holder of a design organisation approval shall be entitled, within the scope of its terms of approval issued under point 21.A.251 and under the relevant procedures of the design management system:’; |
| --- | --- | --- |

(37)

in point 21.A.263(c), the introductory phrase is replaced by the following:

‘(c)

The holder of a design organisation approval shall be entitled, within the scope of its terms of approval issued under point 21.A.251 and under the relevant procedures of the design management system:’;

| (38) | point 21.A.265 is amended as follows:






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






  ‘(c) | determine that the design of the products, or of the changes or repairs thereto, complies with the applicable type-certification basis, operational suitability data certification basis, and the environmental protection requirements, and have no unsafe features;’; |
| --- | --- | --- | --- |

(38)

point 21.A.265 is amended as follows:

(a)

point (c) is replaced by the following:

‘(c)

determine that the design of the products, or of the changes or repairs thereto, complies with the applicable type-certification basis, operational suitability data certification basis, and the environmental protection requirements, and have no unsafe features;’;

| (b) | point (h) is replaced by the following:






  ‘(h) | designate data and information issued under the authority of the approved design organisation within the scope of its terms of approval as established by the Agency with the following statement: “The technical content of this document is approved under the authority of the DOA ref. EASA. 21J.[XXXX]”;’ |
| --- | --- | --- |

(b)

point (h) is replaced by the following:

‘(h)

designate data and information issued under the authority of the approved design organisation within the scope of its terms of approval as established by the Agency with the following statement: “The technical content of this document is approved under the authority of the DOA ref. EASA. 21J.[XXXX]”;’

| (c) | the following point (i) is inserted:






  ‘(i) | comply with Subpart A of this Section.’; |
| --- | --- | --- |

(c)

the following point (i) is inserted:

‘(i)

comply with Subpart A of this Section.’;

| (39) | point 21.A.451 is amended as follows:






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






  ‘(i) | laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.9, 21.A.439, 21.A.441 and 21.A.443;’; |
| --- | --- | --- | --- |

(39)

point 21.A.451 is amended as follows:

(a)

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

‘(i)

laid down in points 21.A.3A, 21.A.3B, 21.A.4, 21.A.5, 21.A.6, 21.A.7, 21.A.9, 21.A.439, 21.A.441 and 21.A.443;’;

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






  ‘1. | undertake the obligations laid down in points 21.A.4, 21.A.5 and 21.A.7;’; |
| --- | --- | --- |

(b)

point (b)(1) is replaced by the following:

‘1.

undertake the obligations laid down in points 21.A.4, 21.A.5 and 21.A.7;’;

| (40) | in point 21.A.604, point (a) is replaced by the following:






  ‘(a) | by way of derogation from points 21.A.9, 21.A.603, 21.A.610 and 21.A.621, the following points shall apply: points 21.A.15, 21.A.20, 21.A.21, 21.A.31, 21.A.33, 21.A.44, 21.A.47, 21.B.75 and 21.B.80. However, an ETSO authorisation shall be issued in accordance with point 21.A.606 instead of the type-certificate;’; |
| --- | --- | --- |

(40)

in point 21.A.604, point (a) is replaced by the following:

‘(a)

by way of derogation from points 21.A.9, 21.A.603, 21.A.610 and 21.A.621, the following points shall apply: points 21.A.15, 21.A.20, 21.A.21, 21.A.31, 21.A.33, 21.A.44, 21.A.47, 21.B.75 and 21.B.80. However, an ETSO authorisation shall be issued in accordance with point 21.A.606 instead of the type-certificate;’;

| (41) | point 21.A.609 is amended as follows:






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






  ‘(b) | prepare and maintain, for each model of each article for which an ETSO authorisation has been issued, an updated set of complete technical data and records in accordance with point 21.A.5;’; |
| --- | --- | --- | --- |

(41)

point 21.A.609 is amended as follows:

(a)

point (b) is replaced by the following:

‘(b)

prepare and maintain, for each model of each article for which an ETSO authorisation has been issued, an updated set of complete technical data and records in accordance with point 21.A.5;’;

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






  ‘(f) | comply with points 21.A.3A, 21.A.3B, 21.A.4 and 21.A.9;’; |
| --- | --- | --- |

(b)

point (f) is replaced by the following:

‘(f)

comply with points 21.A.3A, 21.A.3B, 21.A.4 and 21.A.9;’;

| (42) | point 21.A.615 is deleted; |
| --- | --- |

(42)

point 21.A.615 is deleted;

| (43) | point 21.A.619 is replaced by the following:
  ‘21.A.619   Duration and continued validity







  (a) | An ETSO authorisation shall be issued for an unlimited period of time. It shall remain valid subject to compliance with all the following conditions:






  1. | the conditions set when the ETSO authorisation was granted continue to be observed by the applicant; |
| --- | --- | --- | --- |

(43)

point 21.A.619 is replaced by the following:

‘21.A.619   Duration and continued validity

(a)

An ETSO authorisation shall be issued for an unlimited period of time. It shall remain valid subject to compliance with all the following conditions:

1.

the conditions set when the ETSO authorisation was granted continue to be observed by the applicant;

| 2. | the obligations specified in point 21.A.609 continue to be discharged by the ETSO authorisation holder; |
| --- | --- |

2.

the obligations specified in point 21.A.609 continue to be discharged by the ETSO authorisation holder;

| 3. | the holder of the ETSO authorisation or any of its partners, suppliers or subcontractors acknowledge that the competent authority may carry out investigations in accordance with point 21.A.9; |
| --- | --- |

3.

the holder of the ETSO authorisation or any of its partners, suppliers or subcontractors acknowledge that the competent authority may carry out investigations in accordance with point 21.A.9;

| 4. | it has been proved that the ETSO article does not give rise to unacceptable hazards in service; |
| --- | --- |

4.

it has been proved that the ETSO article does not give rise to unacceptable hazards in service;

| 5. | the ETSO authorisation has not been revoked by the Agency under point 21.B.65, or surrendered by its holder. |
| --- | --- |

5.

the ETSO authorisation has not been revoked by the Agency under point 21.B.65, or surrendered by its holder.

| (b) | Upon surrender or revocation, the ETSO authorisation shall be returned to the Agency.’; |
| --- | --- |

(b)

Upon surrender or revocation, the ETSO authorisation shall be returned to the Agency.’;

| (44) | point 21.A.705 is deleted; |
| --- | --- |

(44)

point 21.A.705 is deleted;

| (45) | in point 21.A.711, the title is replaced by the following:






  ‘21.A.711 | Issuance of a permit to fly’; |
| --- | --- | --- |

(45)

in point 21.A.711, the title is replaced by the following:

‘21.A.711

| (46) | point 21.A.721 is deleted; |
| --- | --- |

(46)

point 21.A.721 is deleted;

| (47) | in point 21.A.723, point (a) is replaced by the following:






  ‘(a) | A permit to fly shall be issued for a maximum period of 12 months and shall remain valid subject to compliance with all the following conditions:






  1. | the organisation continues to comply with the conditions and restrictions associated with the permit to fly as set out in point 21.A.711(e); |
| --- | --- | --- | --- |

(47)

in point 21.A.723, point (a) is replaced by the following:

‘(a)

A permit to fly shall be issued for a maximum period of 12 months and shall remain valid subject to compliance with all the following conditions:

1.

the organisation continues to comply with the conditions and restrictions associated with the permit to fly as set out in point 21.A.711(e);

| 2. | the holder or any of its partners, suppliers or subcontractors acknowledge that the competent authority may carry out investigations in accordance with point 21.A.9; |
| --- | --- |

2.

the holder or any of its partners, suppliers or subcontractors acknowledge that the competent authority may carry out investigations in accordance with point 21.A.9;

| 3. | the permit to fly has not been revoked by the competent authority under point 21.B.65, or surrendered by its holder; |
| --- | --- |

3.

the permit to fly has not been revoked by the competent authority under point 21.B.65, or surrendered by its holder;

| 4. | the aircraft remains on the same register.’; |
| --- | --- |

4.

the aircraft remains on the same register.’;

| (48) | point 21.A.729 is deleted; |
| --- | --- |

(48)

point 21.A.729 is deleted;

| (49) | in point 21.B.103, the title is replaced by the following:






  ‘21.B.103 | Issuance of a type-certificate or a restricted type-certificate’; |
| --- | --- | --- |

(49)

in point 21.B.103, the title is replaced by the following:

‘21.B.103

| (50) | in point 21.B.107, the title is replaced by the following:






  ‘21.B.107 | Issuance of an approval of a change to a type-certificate’; |
| --- | --- | --- |

(50)

in point 21.B.107, the title is replaced by the following:

‘21.B.107

| (51) | in point 21.B.111, the title is replaced by the following:






  ‘21.B.111 | Issuance of a supplemental type-certificate’; |
| --- | --- | --- |

(51)

in point 21.B.111, the title is replaced by the following:

‘21.B.111

| (52) | point 21.B.150 is deleted; |
| --- | --- |

(52)

point 21.B.150 is deleted;

| (53) | point 21.B.260 is deleted; |
| --- | --- |

(53)

point 21.B.260 is deleted;

| (54) | in point 21.B.425, the title is replaced by the following:






  ‘21.B.425 | Issuance of noise certificates’; |
| --- | --- | --- |

(54)

in point 21.B.425, the title is replaced by the following:

‘21.B.425

| (55) | in point 21.B.453, the title is replaced by the following:






  ‘21.B.453 | Issuance of a repair design approval’; |
| --- | --- | --- |

(55)

in point 21.B.453, the title is replaced by the following:

‘21.B.453

| (56) | points 21.B.430 and 21.B.445 are deleted; |
| --- | --- |

(56)

points 21.B.430 and 21.B.445 are deleted;

| (57) | in Section B, Subpart J is replaced by the following::

  ‘
  SUBPART J – DESIGN ORGANISATION APPROVAL


  21.B.430   Initial certification procedure







  (a) | Upon receiving an application for the initial issue of a design organisation approval, the competent authority shall verify the applicant’s compliance with the applicable requirements, |
| --- | --- | --- |

(57)

in Section B, Subpart J is replaced by the following::

‘
  SUBPART J – DESIGN ORGANISATION APPROVAL

21.B.430   Initial certification procedure

(a)

Upon receiving an application for the initial issue of a design organisation approval, the competent authority shall verify the applicant’s compliance with the applicable requirements,

| (b) | A meeting with the head of the design organisation shall be convened at least once during the investigation for initial certification to ensure that this person understands their role and accountability. |
| --- | --- |

(b)

A meeting with the head of the design organisation shall be convened at least once during the investigation for initial certification to ensure that this person understands their role and accountability.

| (c) | The competent authority shall record all the findings issued, closure actions as well as recommendations for the issue of the design organisation approval. |
| --- | --- |

(c)

The competent authority shall record all the findings issued, closure actions as well as recommendations for the issue of the design organisation approval.

| (d) | The competent authority shall confirm to the applicant in writing all the findings raised during the verification. For initial certification, all findings must be corrected to the satisfaction of the competent authority before the design organisation approval can be issued. |
| --- | --- |

(d)

The competent authority shall confirm to the applicant in writing all the findings raised during the verification. For initial certification, all findings must be corrected to the satisfaction of the competent authority before the design organisation approval can be issued.

| (e) | When satisfied that the applicant complies with the applicable requirements, the competent authority shall issue the design organisation approval. |
| --- | --- |

(e)

When satisfied that the applicant complies with the applicable requirements, the competent authority shall issue the design organisation approval.

| (f) | The certificate reference number shall be included in the design organisation approval in a manner specified by the Agency. |
| --- | --- |

(f)

The certificate reference number shall be included in the design organisation approval in a manner specified by the Agency.

| (g) | The certificate shall be issued for an unlimited period of time. The privileges and the scope of the activities that the design organisation is approved to perform, including any limitations as applicable, shall be specified in the terms of approval attached to the design organisation approval. |
| --- | --- |

(g)

The certificate shall be issued for an unlimited period of time. The privileges and the scope of the activities that the design organisation is approved to perform, including any limitations as applicable, shall be specified in the terms of approval attached to the design organisation approval.

21.B.431   Oversight principles

The competent authority shall verify whether certified organisations continue to comply with the applicable requirements

| (a) | The verification shall:






  1. | be supported by documentation specifically intended to provide personnel responsible for oversight with guidance to perform their functions; |
| --- | --- | --- |

(a)

The verification shall:

1.

be supported by documentation specifically intended to provide personnel responsible for oversight with guidance to perform their functions;

| 2. | provide the organisations concerned with the results of oversight activities; |
| --- | --- |

2.

provide the organisations concerned with the results of oversight activities;

| 3. | be based on assessments, audits, inspections and, if needed, unannounced inspections; |
| --- | --- |

3.

be based on assessments, audits, inspections and, if needed, unannounced inspections;

| 4. | provide the competent authority with the evidence needed in case further action is required, including the measures provided for in point 21.B.433. |
| --- | --- |

4.

provide the competent authority with the evidence needed in case further action is required, including the measures provided for in point 21.B.433.

| (b) | The competent authority shall establish the scope of the oversight set out in point (a) taking into account the results of past oversight activities and the safety priorities. |
| --- | --- |

(b)

The competent authority shall establish the scope of the oversight set out in point (a) taking into account the results of past oversight activities and the safety priorities.

| (c) | The competent authority shall collect and process any information deemed necessary for performing oversight activities. |
| --- | --- |

(c)

The competent authority shall collect and process any information deemed necessary for performing oversight activities.

21.B.432   Oversight programme

| (a) | The competent authority shall establish and maintain an oversight programme covering the oversight activities required to comply with point 21.B.431(a). |
| --- | --- |

(a)

The competent authority shall establish and maintain an oversight programme covering the oversight activities required to comply with point 21.B.431(a).

| (b) | The oversight programme shall take into account the specific nature of the organisation, the complexity of its activities, the results of past certification or oversight activities, or both, and it shall be based on the assessment of the associated risks. It shall include, within each oversight planning cycle:






  1. | assessments, audits and inspections, including, where appropriate:






  (i) | management system assessments and process audits; |
| --- | --- | --- | --- |

(b)

The oversight programme shall take into account the specific nature of the organisation, the complexity of its activities, the results of past certification or oversight activities, or both, and it shall be based on the assessment of the associated risks. It shall include, within each oversight planning cycle:

1.

assessments, audits and inspections, including, where appropriate:

(i)

management system assessments and process audits;

| (ii) | product audits of a relevant sample of the design and certification of the products, parts and appliances that are within the scope of work of the organisation; |
| --- | --- |

(ii)

product audits of a relevant sample of the design and certification of the products, parts and appliances that are within the scope of work of the organisation;

| (iii) | sampling of the work performed; |
| --- | --- |

(iii)

sampling of the work performed;

| (iv) | unannounced inspections; |
| --- | --- |

(iv)

unannounced inspections;

| 2. | meetings convened between the head of the design organisation and the competent authority to ensure that both parties remain informed of all significant issues. |
| --- | --- |

2.

meetings convened between the head of the design organisation and the competent authority to ensure that both parties remain informed of all significant issues.

| (c) | The oversight planning cycle shall not exceed 24 months. |
| --- | --- |

(c)

The oversight planning cycle shall not exceed 24 months.

| (d) | Notwithstanding point (c), the oversight planning cycle may be extended to 36 months if the competent authority has established that during the previous 24 months:






  1. | the organisation has demonstrated that it can effectively identify aviation safety hazards and manage the associated risks; |
| --- | --- | --- |

(d)

Notwithstanding point (c), the oversight planning cycle may be extended to 36 months if the competent authority has established that during the previous 24 months:

1.

the organisation has demonstrated that it can effectively identify aviation safety hazards and manage the associated risks;

| 2. | the organisation has continuously demonstrated compliance with point 21.A.247 and has full control over all changes to the design management system; |
| --- | --- |

2.

the organisation has continuously demonstrated compliance with point 21.A.247 and has full control over all changes to the design management system;

| 3. | no level 1 findings have been issued; |
| --- | --- |

3.

no level 1 findings have been issued;

| 4. | all corrective actions have been implemented within the time period that was accepted or extended by the competent authority as provided for in point 21.B.433(d).
  Notwithstanding point (c), the oversight planning cycle may be further extended to a maximum of 48 months if, in addition to the conditions laid down in points (d)(1) to (d)(4), the organisation has established, and the competent authority has approved, an effective continuous system for reporting to the competent authority on the safety performance and regulatory compliance of the organisation itself. |
| --- | --- |

4.

all corrective actions have been implemented within the time period that was accepted or extended by the competent authority as provided for in point 21.B.433(d).

Notwithstanding point (c), the oversight planning cycle may be further extended to a maximum of 48 months if, in addition to the conditions laid down in points (d)(1) to (d)(4), the organisation has established, and the competent authority has approved, an effective continuous system for reporting to the competent authority on the safety performance and regulatory compliance of the organisation itself.

| (e) | The oversight planning cycle may be reduced if there is evidence that the safety performance of the organisation has decreased. |
| --- | --- |

(e)

The oversight planning cycle may be reduced if there is evidence that the safety performance of the organisation has decreased.

| (f) | The oversight programme shall include records of the dates when assessments, audits, inspections and meetings are due, and when assessments, audits, inspections and meetings have been effectively carried out. |
| --- | --- |

(f)

The oversight programme shall include records of the dates when assessments, audits, inspections and meetings are due, and when assessments, audits, inspections and meetings have been effectively carried out.

| (g) | At the completion of each oversight planning cycle, the competent authority shall issue a recommendation report on the continuation of the approval, reflecting the results of the oversight. |
| --- | --- |

(g)

At the completion of each oversight planning cycle, the competent authority shall issue a recommendation report on the continuation of the approval, reflecting the results of the oversight.

21.B.433   Findings and corrective actions; observations

| (a) | The competent authority shall have a system in place to analyse findings for their safety significance. |
| --- | --- |

(a)

The competent authority shall have a system in place to analyse findings for their safety significance.

| (b) | A level 1 finding shall be issued by the competent authority when a non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the design organisation’s certificate including the terms of approval, which may lead to uncontrolled non-compliances and to a potential unsafe condition.
  The level 1 findings shall also include:






  1. | any failure to grant the competent authority access to the organisation’s facilities referred to in point 21.A.9 during normal operating hours and after two written requests; |
| --- | --- | --- |

(b)

A level 1 finding shall be issued by the competent authority when a non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the design organisation’s certificate including the terms of approval, which may lead to uncontrolled non-compliances and to a potential unsafe condition.

The level 1 findings shall also include:

1.

any failure to grant the competent authority access to the organisation’s facilities referred to in point 21.A.9 during normal operating hours and after two written requests;

| 2. | obtaining the design organisation approval or maintaining its validity by falsification of the submitted documentary evidence; |
| --- | --- |

2.

obtaining the design organisation approval or maintaining its validity by falsification of the submitted documentary evidence;

| 3. | any evidence of malpractice or fraudulent use of the design organisation approval; |
| --- | --- |

3.

any evidence of malpractice or fraudulent use of the design organisation approval;

| 4. | failure to appoint a head of the design organisation pursuant to point 21.A.245(a). |
| --- | --- |

4.

failure to appoint a head of the design organisation pursuant to point 21.A.245(a).

| (c) | A level 2 finding shall be issued by the competent authority when any non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the certificate including the terms of approval, which is not classified as a level 1 finding. |
| --- | --- |

(c)

A level 2 finding shall be issued by the competent authority when any non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the certificate including the terms of approval, which is not classified as a level 1 finding.

| (d) | When a finding is detected during oversight or by any other means, the competent authority shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and its delegated and implementing acts, communicate in writing the finding to the organisation and request corrective action to address the non-compliance(s) identified. Where a level 1 finding directly relates to a product, the competent authority shall inform the competent authority of the Member State in which the aircraft is registered.






  1. | If there are any level 1 findings, the competent authority shall:






  (i) | grant the organisation a corrective action implementation period that is appropriate to the nature of the finding and that in any case shall not be more than 21 working days. That period shall commence from the date of the written communication of the finding to the organisation requesting corrective action to address the non-compliance(s) identified; |
| --- | --- | --- | --- |

(d)

When a finding is detected during oversight or by any other means, the competent authority shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and its delegated and implementing acts, communicate in writing the finding to the organisation and request corrective action to address the non-compliance(s) identified. Where a level 1 finding directly relates to a product, the competent authority shall inform the competent authority of the Member State in which the aircraft is registered.

1.

If there are any level 1 findings, the competent authority shall:

(i)

grant the organisation a corrective action implementation period that is appropriate to the nature of the finding and that in any case shall not be more than 21 working days. That period shall commence from the date of the written communication of the finding to the organisation requesting corrective action to address the non-compliance(s) identified;

| (ii) | assess the corrective action plan and implementation plan proposed by the organisation, and if it concludes that they are sufficient to address the non-compliance(s), accept them; |
| --- | --- |

(ii)

assess the corrective action plan and implementation plan proposed by the organisation, and if it concludes that they are sufficient to address the non-compliance(s), accept them;

| (iii) | if the organisation fails to submit an acceptable corrective action plan, or fails to perform the corrective action within the time period accepted by the competent authority, take immediate and appropriate action to prohibit or limit the activities of the organisation involved and, if appropriate, take action to revoke the design organisation approval or to limit or suspend it in whole or in part, depending upon the extent of the level 1 finding, until successful corrective action has been taken by the organisation. |
| --- | --- |

(iii)

if the organisation fails to submit an acceptable corrective action plan, or fails to perform the corrective action within the time period accepted by the competent authority, take immediate and appropriate action to prohibit or limit the activities of the organisation involved and, if appropriate, take action to revoke the design organisation approval or to limit or suspend it in whole or in part, depending upon the extent of the level 1 finding, until successful corrective action has been taken by the organisation.

| 2. | If there are any level 2 findings, the competent authority shall:






  (i) | grant the organisation a corrective action implementation period that is appropriate to the nature of the finding, and that in any case shall initially not be more than 3 months. That period shall commence from the date of the written communication of the finding requesting corrective action. At the end of this period, and subject to the nature of the finding, the competent authority may extend the 3-month period provided that a corrective action plan has been agreed by the competent authority; |
| --- | --- | --- |

2.

If there are any level 2 findings, the competent authority shall:

(i)

grant the organisation a corrective action implementation period that is appropriate to the nature of the finding, and that in any case shall initially not be more than 3 months. That period shall commence from the date of the written communication of the finding requesting corrective action. At the end of this period, and subject to the nature of the finding, the competent authority may extend the 3-month period provided that a corrective action plan has been agreed by the competent authority;

| (ii) | assess the corrective action and the implementation plan proposed by the organisation, and if it concludes that they are sufficient to address the non-compliance(s), accept them; |
| --- | --- |

(ii)

assess the corrective action and the implementation plan proposed by the organisation, and if it concludes that they are sufficient to address the non-compliance(s), accept them;

| (iii) | if the organisation fails to submit an acceptable corrective action plan, or fails to perform the corrective action within the time period accepted or extended by the competent authority, the finding shall be raised to level 1 and action shall be taken as laid down in point (d)(1). |
| --- | --- |

(iii)

if the organisation fails to submit an acceptable corrective action plan, or fails to perform the corrective action within the time period accepted or extended by the competent authority, the finding shall be raised to level 1 and action shall be taken as laid down in point (d)(1).

| (e) | The competent authority may issue observations for any of the following cases not requiring level 1 or level 2 findings:






  1. | for any item whose performance has been assessed to be ineffective; |
| --- | --- | --- |

(e)

The competent authority may issue observations for any of the following cases not requiring level 1 or level 2 findings:

1.

for any item whose performance has been assessed to be ineffective;

| 2. | when it has been identified that an item has the potential to cause a non-compliance under points (b) or (c); |
| --- | --- |

2.

when it has been identified that an item has the potential to cause a non-compliance under points (b) or (c);

| 3. | when suggestions or improvements are of interest for the overall safety performance of the organisation.
  The observations issued under this point shall be communicated in writing to the organisation and recorded by the competent authority. |
| --- | --- |

3.

when suggestions or improvements are of interest for the overall safety performance of the organisation.

The observations issued under this point shall be communicated in writing to the organisation and recorded by the competent authority.

21.B.435   Changes in the design management system

| (a) | Upon receiving an application for a significant change to the design management system, the competent authority shall verify the organisation’s compliance with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, before issuing the approval. |
| --- | --- |

(a)

Upon receiving an application for a significant change to the design management system, the competent authority shall verify the organisation’s compliance with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, before issuing the approval.

| (b) | The competent authority shall establish the conditions under which the organisation may operate during the change unless the competent authority determines that the design organisation approval needs to be suspended. |
| --- | --- |

(b)

The competent authority shall establish the conditions under which the organisation may operate during the change unless the competent authority determines that the design organisation approval needs to be suspended.

| (c) | When it is satisfied that the organisation complies with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, the competent authority shall approve the change. |
| --- | --- |

(c)

When it is satisfied that the organisation complies with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, the competent authority shall approve the change.

| (d) | Without prejudice to any additional enforcement measures, if the organisation implements a significant change to the design management system without having received the approval of the competent authority pursuant to point (c), the competent authority shall consider the need to suspend, limit or revoke the organisation’s certificate. |
| --- | --- |

(d)

Without prejudice to any additional enforcement measures, if the organisation implements a significant change to the design management system without having received the approval of the competent authority pursuant to point (c), the competent authority shall consider the need to suspend, limit or revoke the organisation’s certificate.

| (e) | For non-significant changes to the design management system, the competent authority shall include the review of such changes in its continuing oversight in accordance with the principles set forth in point 21.B.431. If any non-compliance is found, the competent authority shall notify the organisation, request further changes and act in accordance with point 21.B.433.’; |
| --- | --- |

(e)

For non-significant changes to the design management system, the competent authority shall include the review of such changes in its continuing oversight in accordance with the principles set forth in point 21.B.431. If any non-compliance is found, the competent authority shall notify the organisation, request further changes and act in accordance with point 21.B.433.’;

| (58) | in point 21.B.453, the title is replaced by the following






  ‘21.B.453 | Issuance of a repair design approval’; |
| --- | --- | --- |

(58)

in point 21.B.453, the title is replaced by the following

‘21.B.453

| (59) | in point 21.B.480, the title is replace by the following:






  ‘21.B.480 | Issuance of an ETSO authorisation’; |
| --- | --- | --- |

(59)

in point 21.B.480, the title is replace by the following:

‘21.B.480

| (60) | Appendix VIII is replaced by the following:


  ‘Appendix VIII
  Aircraft statement of conformity – EASA Form 52









  AIRCRAFT STATEMENT OF CONFORMITY |
| --- | --- |
| 1. | State of manufacture |

(60)

Appendix VIII is replaced by the following:

‘Appendix VIII

Aircraft statement of conformity – EASA Form 52

AIRCRAFT STATEMENT OF CONFORMITY

1.

State of manufacture

| 2. | [MEMBER STATE] (1) A Member of the European Union (2) |
| --- | --- |

2.

[MEMBER STATE] (1) A Member of the European Union (2)

| 3. | Statement ref. no: |
| --- | --- |

3.

Statement ref. no:

| 4. | Organisation |
| --- | --- |

4.

Organisation

| 5. | Aircraft type |
| --- | --- |

5.

Aircraft type

| 6. | Type-certificate ref. nos: |
| --- | --- |

6.

Type-certificate ref. nos:

| 7. | Aircraft registration or mark |
| --- | --- |

7.

Aircraft registration or mark

| 8. | Production organisation identification no: |
| --- | --- |

8.

Production organisation identification no:

| 9. | Engine/propeller details (3) |
| --- | --- |

9.

Engine/propeller details (3)

| 10. | Modifications and/or service bulletins (3) |
| --- | --- |

10.

Modifications and/or service bulletins (3)

| 11. | Airworthiness directives |
| --- | --- |

11.

Airworthiness directives

| 12. | Concessions |
| --- | --- |

12.

Concessions

| 13. | Exemptions, waivers or derogations (3) |
| --- | --- |

13.

Exemptions, waivers or derogations (3)

| 14. | Remarks |
| --- | --- |

14.

Remarks

| 15. | Certificate of airworthiness |
| --- | --- |

15.

Certificate of airworthiness

| 16. | Additional requirements |
| --- | --- |

16.

Additional requirements

| 17. | Statement of conformity
  It is hereby certified that the aircraft conforms fully to the type-certified design and to the items in blocks 9, 10, 11, 12 and 13.
  The aircraft is in a condition for safe operation.
  The aircraft has been satisfactorily tested in flight. |
| --- | --- |

17.

Statement of conformity

It is hereby certified that the aircraft conforms fully to the type-certified design and to the items in blocks 9, 10, 11, 12 and 13.

The aircraft is in a condition for safe operation.

The aircraft has been satisfactorily tested in flight.

| 18. | Signed |
| --- | --- |

18.

Signed

| 19. | Name |
| --- | --- |

19.

Name

| 20. | Date (d/m/y) |
| --- | --- |

20.

Date (d/m/y)

| 21. | Production organisation approval reference |
| --- | --- |

21.

Production organisation approval reference

EASA Form 52 – Issue 3

| (1) | Or “EASA”, if EASA is the competent authority. |
| --- | --- |

(1)

| (2) | Delete for non-EU Member States or EASA. |
| --- | --- |

(2)

| (3) | Delete as applicable. |
| --- | --- |

(3)

Instructions for the use of the “Aircraft statement of conformity – EASA Form 52”

1.   PURPOSE AND SCOPE

| 1.1. | The use of the aircraft statement of conformity issued by a production organisation that produces under Part 21 Section A Subpart F is described in point 21.A.130 and in the related acceptable means of compliance (AMC). |
| --- | --- |

1.1.

| 1.2. | The purpose of the aircraft statement of conformity (EASA Form 52) issued under Part 21 Section A Subpart G is to enable the holder of an appropriate production organisation approval certificate to exercise the privilege to obtain an individual aircraft certificate of airworthiness and, if requested, a certificate of noise from the competent authority of the Member State of registry. |
| --- | --- |

1.2.

2.   GENERAL

| 2.1. | The statement of conformity must comply with the model, including the block numbers and the location of each block. The size of each block may, however, be varied to suit the individual application, but not to the extent that would render the statement of conformity unrecognisable. If in doubt, consult the competent authority. |
| --- | --- |

2.1.

| 2.2. | The statement of conformity must be either preprinted or computer generated, but in either case, the printing of lines and characters must be clear and legible. Preprinted wording is permitted in accordance with the attached model, but no other certification statements are permitted. |
| --- | --- |

2.2.

| 2.3. | The completion of the statement may be either machine/computer printed or handwritten, using block letters to allow for easy reading. English, and where relevant, one or more of the official language(s) of the issuing Member State, are acceptable. |
| --- | --- |

2.3.

| 2.4. | A copy of the statement and all the referenced attachments are to be retained by the approved production organisation. |
| --- | --- |

2.4.

3.   COMPLETION OF THE STATEMENT OF CONFORMITY BY THE ORIGINATOR

| 3.1. | There must be an entry in all blocks to render the document a valid statement. |
| --- | --- |

3.1.

| 3.2. | A statement of conformity may not be issued to the competent authority of the Member State of registry unless the design of the aircraft and its installed products are approved. |
| --- | --- |

3.2.

| 3.3. | The information required in blocks 9, 10, 11, 12, 13 and 14 may be by reference to separate identified documents held on file by the production organisation, unless the competent authority agrees otherwise. |
| --- | --- |

3.3.

| 3.4. | This statement of conformity is not intended to include those items of equipment that may be required to be fitted in order to satisfy the applicable operational rules. However, some of those individual items may be included in block 10 or in the approved type design. Operators are therefore reminded of their responsibility to ensure compliance with the applicable operational rules for their own particular operations.







  Block 1 | Enter the name of the State of manufacture. |
| --- | --- | --- |
| Block 2 | The competent authority that issues the statement of conformity under its authority. |
| Block 3 | A unique serial number must be preprinted in this block for statement control and traceability purposes. An exception is in the case of a computer-generated document: the number need not be preprinted where the computer is programmed to produce and print a unique number. |
| Block 4 | The full name and the address of the location of the organisation that issues the statement. This block may be preprinted. Logos, etc., are permitted if the logo, etc., can be contained within the block. |
| Block 5 | The aircraft type in full as specified in the type-certificate and its associated data sheet. |
| Block 6 | The type-certificate reference numbers and issue for the subject aircraft. |
| Block 7 | If the aircraft is registered, then this mark will be the registration mark. If the aircraft is not registered, then this will be the mark that is accepted by the competent authority of the Member State and, if applicable, by the competent authority of a third country. |
| Block 8 | The identification number assigned by the production organisation for control and traceability and product support purposes. This is sometimes referred to as a “production organisation serial number” or “constructor’s number”. |
| Block 9 | The engine type and the propeller type(s) in full as specified in the relevant type-certificate and its associated data sheet. Their production organisation identification number and the associated location must also be stated. |
| Block 10 | Approved design changes to the aircraft definition. |
| Block 11 | A listing of all the applicable airworthiness directives (or equivalent) and a declaration of compliance, together with a description of the method of compliance of the subject individual aircraft, including products and installed parts, appliances and equipment. Any future compliance requirement time must be stated. |
| Block 12 | Approved unintentional deviations from the approved type design, sometimes referred to as “concessions”, “divergences” or “non-conformances”. |
| Block 13 | Only agreed exemptions, waivers or derogations may be included here. |
| Block 14 | Remarks. Any statement, information, particular data or limitation which may affect the airworthiness of the subject aircraft. If there is no such information or data, state “NONE”. |
| Block 15 | Enter “certificate of airworthiness”, or “restricted certificate of airworthiness”, as requested. |
| Block 16 | Additional requirements such as those notified by an importing country must be noted in this block. |
| Block 17 | The validity of the statement of conformity is subject to the full completion of all the blocks on the form. A copy of the flight test report, together with any recorded defects and rectification details, must be kept on file by the production organisation approval certificate holder. The report must be signed as satisfactory by the appropriate certifying staff and a flight crew member, e.g. the test pilot or the flight test engineer. The flight tests performed are those defined under the control of the quality management element of the production system, as established by point 21.A.139, in particular point 21.A.139(d)(1)(vi), to ensure that the aircraft conforms to the applicable design data, and is in condition for safe operation.
  The listing of items provided (or made available) to satisfy the aspects of this statement that relate to the safe operation of the aircraft must be kept on file by the production organisation approval certificate holder. |
| Block 18 | The statement of conformity may be signed by the person that is authorised to do so by the production approval holder in accordance with point 21.A.145(d). A rubber stamp signature must not be used. |
| Block 19 | The name of the person that signs the statement must be typed or printed in a legible form. |
| Block 20 | The date on which the statement of conformity is signed must be given. |
| Block 21 | The competent authority approval reference must be quoted. |

3.4.

Block 1

Enter the name of the State of manufacture.

Block 2

The competent authority that issues the statement of conformity under its authority.

Block 3

A unique serial number must be preprinted in this block for statement control and traceability purposes. An exception is in the case of a computer-generated document: the number need not be preprinted where the computer is programmed to produce and print a unique number.

Block 4

The full name and the address of the location of the organisation that issues the statement. This block may be preprinted. Logos, etc., are permitted if the logo, etc., can be contained within the block.

Block 5

The aircraft type in full as specified in the type-certificate and its associated data sheet.

Block 6

The type-certificate reference numbers and issue for the subject aircraft.

Block 7

If the aircraft is registered, then this mark will be the registration mark. If the aircraft is not registered, then this will be the mark that is accepted by the competent authority of the Member State and, if applicable, by the competent authority of a third country.

Block 8

The identification number assigned by the production organisation for control and traceability and product support purposes. This is sometimes referred to as a “production organisation serial number” or “constructor’s number”.

Block 9

The engine type and the propeller type(s) in full as specified in the relevant type-certificate and its associated data sheet. Their production organisation identification number and the associated location must also be stated.

Block 10

Approved design changes to the aircraft definition.

Block 11

A listing of all the applicable airworthiness directives (or equivalent) and a declaration of compliance, together with a description of the method of compliance of the subject individual aircraft, including products and installed parts, appliances and equipment. Any future compliance requirement time must be stated.

Block 12

Approved unintentional deviations from the approved type design, sometimes referred to as “concessions”, “divergences” or “non-conformances”.

Block 13

Only agreed exemptions, waivers or derogations may be included here.

Block 14

Remarks. Any statement, information, particular data or limitation which may affect the airworthiness of the subject aircraft. If there is no such information or data, state “NONE”.

Block 15

Enter “certificate of airworthiness”, or “restricted certificate of airworthiness”, as requested.

Block 16

Additional requirements such as those notified by an importing country must be noted in this block.

Block 17

The validity of the statement of conformity is subject to the full completion of all the blocks on the form. A copy of the flight test report, together with any recorded defects and rectification details, must be kept on file by the production organisation approval certificate holder. The report must be signed as satisfactory by the appropriate certifying staff and a flight crew member, e.g. the test pilot or the flight test engineer. The flight tests performed are those defined under the control of the quality management element of the production system, as established by point 21.A.139, in particular point 21.A.139(d)(1)(vi), to ensure that the aircraft conforms to the applicable design data, and is in condition for safe operation.

The listing of items provided (or made available) to satisfy the aspects of this statement that relate to the safe operation of the aircraft must be kept on file by the production organisation approval certificate holder.

Block 18

The statement of conformity may be signed by the person that is authorised to do so by the production approval holder in accordance with point 21.A.145(d). A rubber stamp signature must not be used.

Block 19

The name of the person that signs the statement must be typed or printed in a legible form.

Block 20

The date on which the statement of conformity is signed must be given.

Block 21

The competent authority approval reference must be quoted.

| (61) | Appendix X is replaced by the following:


  ‘Appendix X
  Production organisation approval certificate – EASA Form 55
  Production organisation approval certificates referred to in Subpart G of Annex I (Part 21)





  [MEMBER STATE] (1)
  A Member of the European Union (2)

  PRODUCTION ORGANISATION APPROVAL CERTIFICATE

  Reference: [MEMBER STATE CODE (1)].21G.XXXX
  Pursuant to Regulation (EU) 2018/1139 of the European Parliament and of the Council and to Commission Regulation (EU) No 748/2012, for the time being in force and subject to the conditions specified below, the [COMPETENT AUTHORITY OF THE MEMBER STATE] hereby certifies:
  [COMPANY NAME AND ADDRESS]
  as a production organisation in compliance with Annex I (Part 21) Section A of Regulation (EU) No 748/2012, is approved to produce products, parts and appliances listed in the attached approval schedule and issue the related certificates using the above references.
  CONDITIONS:






  1. | This approval is limited to that specified in the enclosed terms of approval. |
| --- | --- | --- |

(61)

Appendix X is replaced by the following:

‘Appendix X

Production organisation approval certificate – EASA Form 55

Production organisation approval certificates referred to in Subpart G of Annex I (Part 21)

[MEMBER STATE] (1)

A Member of the European Union (2)

PRODUCTION ORGANISATION APPROVAL CERTIFICATE

Reference: [MEMBER STATE CODE (1)].21G.XXXX

Pursuant to Regulation (EU) 2018/1139 of the European Parliament and of the Council and to Commission Regulation (EU) No 748/2012, for the time being in force and subject to the conditions specified below, the [COMPETENT AUTHORITY OF THE MEMBER STATE] hereby certifies:

[COMPANY NAME AND ADDRESS]

as a production organisation in compliance with Annex I (Part 21) Section A of Regulation (EU) No 748/2012, is approved to produce products, parts and appliances listed in the attached approval schedule and issue the related certificates using the above references.

CONDITIONS:

1.

This approval is limited to that specified in the enclosed terms of approval.

| 2. | This approval is subject to compliance with the procedures specified in the approved production organisation exposition. |
| --- | --- |

2.

This approval is subject to compliance with the procedures specified in the approved production organisation exposition.

| 3. | This approval is valid while the approved production organisation remains in compliance with Annex I (Part 21) to Regulation (EU) No 748/2012. |
| --- | --- |

3.

This approval is valid while the approved production organisation remains in compliance with Annex I (Part 21) to Regulation (EU) No 748/2012.

| 4. | Subject to compliance with the foregoing conditions, this approval shall remain valid for an unlimited period of time unless it has previously been surrendered, superseded, suspended or revoked.
  Date of original issue:...
  Date of this revision:...
  Revision No:...
  Signed:...
  For the competent authority: [COMPETENTAUTHORITY IDENTIFICATION (1)] |
| --- | --- |

4.

Subject to compliance with the foregoing conditions, this approval shall remain valid for an unlimited period of time unless it has previously been surrendered, superseded, suspended or revoked.

Date of original issue:...

Date of this revision:...

Revision No:...

Signed:...

For the competent authority: [COMPETENTAUTHORITY IDENTIFICATION (1)]

EASA Form 55a – Issue 3

| (1) | Or “EASA”, if EASA is the competent authority. |
| --- | --- |

(1)

| (2) | Delete for non-EU Member States. |
| --- | --- |

(2)

| [MEMBER STATE] (1)
  A Member of the European Union (2) | Terms of approval | TA: [MEMBER STATE CODE (1)].21G.XXXX |
| --- | --- | --- |
| This document is part of the production organisation approval number [MEMBER STATE CODE (1)].21G.XXXX issued to:
  Company name: |
| Section 1. SCOPE OF WORK: |
| PRODUCTION OF | PRODUCTS/CATEGORIES |
| | |
| | |
| | |
| | |
| | |
| For details and limitations, refer to the Production Organisation Exposition, Section xxx |
| Section 2. LOCATIONS: |
| Section 3. PRIVILEGES: |
| |
| The production organisation is entitled to exercise, within its terms of approval and in accordance with the procedures of its Production Organisation Exposition, the privileges laid down in point 21.A.163, subject to the following: |
| [keep only applicable text] |
| Prior to the approval of the design of the product, the EASA Form 1 may be issued only for conformity purposes. |
| A statement of conformity may not be issued for a non-approved aircraft. |
| Maintenance may be performed, until compliance with the maintenance regulations is required, in accordance with the Production Organisation Exposition Section xxx |
| Permits to fly may be issued in accordance with the Production Organisation Exposition Section yyy |
| Date of original issue: | Signed: |
| Date of this revision: | |
| Revision No: | For [COMPETENT AUTHORITY IDENTIFICATION (1)] |
| EASA Form 55b – Issue 3 |

[MEMBER STATE] (1)

A Member of the European Union (2)

Terms of approval

TA: [MEMBER STATE CODE (1)].21G.XXXX

This document is part of the production organisation approval number [MEMBER STATE CODE (1)].21G.XXXX issued to:

Company name:

Section 1. SCOPE OF WORK:

PRODUCTION OF

PRODUCTS/CATEGORIES

For details and limitations, refer to the Production Organisation Exposition, Section xxx

Section 2. LOCATIONS:

Section 3. PRIVILEGES:

The production organisation is entitled to exercise, within its terms of approval and in accordance with the procedures of its Production Organisation Exposition, the privileges laid down in point 21.A.163, subject to the following:

[keep only applicable text]

Prior to the approval of the design of the product, the EASA Form 1 may be issued only for conformity purposes.

A statement of conformity may not be issued for a non-approved aircraft.

Maintenance may be performed, until compliance with the maintenance regulations is required, in accordance with the Production Organisation Exposition Section xxx

Permits to fly may be issued in accordance with the Production Organisation Exposition Section yyy

Date of original issue:

Signed:

Date of this revision:

Revision No:

For [COMPETENT AUTHORITY IDENTIFICATION (1)]

EASA Form 55b – Issue 3

| (1) | Or “EASA”, if EASA is the competent authority. |
| --- | --- |

(1)

| (2) | Delete for non-EU Member States. |
| --- | --- |

(2)

| (62) | Appendix XI is replaced by the following:


  ‘Appendix XI
  Letter of agreement for production without a production organisation approval – EASA Form 65
  Letter of agreement referred to in Subpart F of Annex I (Part 21)









  [MEMBER STATE] (1)
  A Member of the European Union (2)

  LETTER OF AGREEMENT FOR PRODUCTION WITHOUT A PRODUCTION ORGANISATION APPROVAL

  [NAME OF THE APPLICANT]
  [TRADE NAME (if different from the name of the applicant)]
  [FULL POSTAL ADDRESS OF THE APPLICANT]
  Date (Day, Month, Year)
  Reference: [MEMBER STATE CODE (2)].21F.XXXX
  Dear Mr/Ms [Name of the Applicant],
  Your production inspection system has been evaluated and found to be in compliance with Section A, Subpart A and Subpart F of Annex I (Part 21) to Commission Regulation (EU) No 748/2012.
  Therefore, subject to the conditions specified below, we agree that the showing of conformity of the products, parts and appliances mentioned below may be done under Section A, Subpart F of Annex I (Part 21) to Regulation (EU) No 748/2012. |
| --- | --- |
| No of Units | P/N | S/N | | |
| AIRCRAFT
  PARTS
  The following conditions are applicable to this letter of agreement:






  (1) | It is valid while [Company Name] remains in compliance with Section A, Subpart A and Subpart F of Annex I (Part 21) to Regulation (EU) No 748/2012. |

(62)

Appendix XI is replaced by the following:

‘Appendix XI

Letter of agreement for production without a production organisation approval – EASA Form 65

Letter of agreement referred to in Subpart F of Annex I (Part 21)

[MEMBER STATE] (1)

A Member of the European Union (2)

LETTER OF AGREEMENT FOR PRODUCTION WITHOUT A PRODUCTION ORGANISATION APPROVAL

[NAME OF THE APPLICANT]

[TRADE NAME (if different from the name of the applicant)]

[FULL POSTAL ADDRESS OF THE APPLICANT]

Date (Day, Month, Year)

Reference: [MEMBER STATE CODE (2)].21F.XXXX

Dear Mr/Ms [Name of the Applicant],

Your production inspection system has been evaluated and found to be in compliance with Section A, Subpart A and Subpart F of Annex I (Part 21) to Commission Regulation (EU) No 748/2012.

Therefore, subject to the conditions specified below, we agree that the showing of conformity of the products, parts and appliances mentioned below may be done under Section A, Subpart F of Annex I (Part 21) to Regulation (EU) No 748/2012.

No of Units

P/N

S/N

AIRCRAFT

PARTS

The following conditions are applicable to this letter of agreement:

(1)

It is valid while [Company Name] remains in compliance with Section A, Subpart A and Subpart F of Annex I (Part 21) to Regulation (EU) No 748/2012.

| (2) | It requires compliance with the procedures specified in [Company Name] manual ref./issue date... |
| --- | --- |

(2)

It requires compliance with the procedures specified in [Company Name] manual ref./issue date...

| (3) | It terminates on... |
| --- | --- |

(3)

It terminates on...

| (4) | The statement of conformity issued by [Company Name] under point 21.A.130 of Regulation (EU) No 748/2012 shall be validated by the issuing authority of this letter of agreement in accordance with the procedure... of the referenced manual. |
| --- | --- |

(4)

The statement of conformity issued by [Company Name] under point 21.A.130 of Regulation (EU) No 748/2012 shall be validated by the issuing authority of this letter of agreement in accordance with the procedure... of the referenced manual.

| (5) | [Company Name] shall notify the issuing authority of this letter of agreement immediately of any changes to the production inspection system that may affect the inspection, conformity or airworthiness of the products and parts listed in this letter.
  For the competent authority: [COMPETENT AUTHORITY IDENTIFICATION (1)(2)]
  Date and signature |
| --- | --- |

(5)

[Company Name] shall notify the issuing authority of this letter of agreement immediately of any changes to the production inspection system that may affect the inspection, conformity or airworthiness of the products and parts listed in this letter.

For the competent authority: [COMPETENT AUTHORITY IDENTIFICATION (1)(2)]

Date and signature

EASA Form 65 – Issue 3

| (1) | Or “EASA”, if EASA is the competent authority. |
| --- | --- |

(1)

| (2) | Delete for non-EU Member States. |
| --- | --- |

(2)

---

(*1)  Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18).’;’

*1

---

ANNEX II

In Annex I (Part 21), point 21.A.101, point (h) is replaced by the following:

| ‘(h) | For large aeroplanes subject to point 26.300 of Annex I to Commission Regulation (EU) 2015/640 (*1), the applicant shall comply with certification specifications that provide at least an equivalent level of safety to points 26.300 and 26.330 of Annex I to Regulation (EU) 2015/640, except for applicants for supplemental type-certificates who are not required to take into account point 26.303. |
| --- | --- |

‘(h)

For large aeroplanes subject to point 26.300 of Annex I to Commission Regulation (EU) 2015/640 (*1), the applicant shall comply with certification specifications that provide at least an equivalent level of safety to points 26.300 and 26.330 of Annex I to Regulation (EU) 2015/640, except for applicants for supplemental type-certificates who are not required to take into account point 26.303.

---

(*1)  Commission Regulation (EU) 2015/640 of 23 April 2015 on additional airworthiness specifications for a given type of operations and amending Regulation (EU) No 965/2012 (OJ L 106, 24.4.2015, p. 18).’.’

---

| 15.2.2022 | EN | Official Journal of the European Union | L 33/41 |
| --- | --- | --- | --- |

15.2.2022

EN

Official Journal of the European Union

L 33/41

---

COMMISSION IMPLEMENTING REGULATION (EU) 2022/202

of 14 February 2022

correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 (1), and in particular Article 8 thereof,

After consulting the Standing Committee on Plants, Animals, Food and Feed,

Whereas:

| (1) | Pursuant to Article 8 of Regulation (EU) 2015/2283, the Commission was to establish, by 1 January 2018, the Union list of novel foods authorised or notified under Regulation (EC) No 258/97 of the European Parliament and of the Council (2). |
| --- | --- |

(1)

Pursuant to Article 8 of Regulation (EU) 2015/2283, the Commission was to establish, by 1 January 2018, the Union list of novel foods authorised or notified under Regulation (EC) No 258/97 of the European Parliament and of the Council (2).

| (2) | The Union list of novel foods authorised or notified under Regulation (EC) No 258/97 was established by Commission Implementing Regulation (EU) 2017/2470 (3). |
| --- | --- |

(2)

The Union list of novel foods authorised or notified under Regulation (EC) No 258/97 was established by Commission Implementing Regulation (EU) 2017/2470 (3).

| (3) | The Commission has identified errors in the Annex to Implementing Regulation (EU) 2017/2470. Corrections are needed in order to provide clarity and legal certainty to food business operators and to the Member States’ competent authorities, thus ensuring the proper implementation and use of the Union list of novel foods. |
| --- | --- |

(3)

The Commission has identified errors in the Annex to Implementing Regulation (EU) 2017/2470. Corrections are needed in order to provide clarity and legal certainty to food business operators and to the Member States’ competent authorities, thus ensuring the proper implementation and use of the Union list of novel foods.

| (4) | The novel food ‘Cistus incanus L. Pandalis herb’ was authorised under certain conditions of use by the Czech competent authority pursuant to Article 5 of Regulation (EC) No 258/97. The specifications for this novel food erroneously omitted that the novel food consists of the dried and cut aerial parts (young shoots with woody parts) of Cistus incanus L. Pandalis Furthermore, the specifications erroneously added detailed composition information on the novel food that the applicant had submitted as complementary information, which was not included in the opinion delivered by the Czech competent authority and is not needed for the safety assessment or the product characterisation. This information should thus be removed. Therefore, the specifications concerning ‘Cistus incanus L. Pandalis herb’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 should be corrected. |
| --- | --- |

(4)

The novel food ‘Cistus incanus L. Pandalis herb’ was authorised under certain conditions of use by the Czech competent authority pursuant to Article 5 of Regulation (EC) No 258/97. The specifications for this novel food erroneously omitted that the novel food consists of the dried and cut aerial parts (young shoots with woody parts) of Cistus incanus L. Pandalis Furthermore, the specifications erroneously added detailed composition information on the novel food that the applicant had submitted as complementary information, which was not included in the opinion delivered by the Czech competent authority and is not needed for the safety assessment or the product characterisation. This information should thus be removed. Therefore, the specifications concerning ‘Cistus incanus L. Pandalis herb’ in Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 should be corrected.

| (5) | Commission Implementing Regulation (EU) 2021/1318 (4) corrected the Union list of authorised novel foods to include the novel food ‘Calcium L-Methylfolate’ which, although authorised in January 2008 by the Irish competent authority under certain conditions of use in accordance with Regulation (EC) No 258/97, was erroneously not included in the Union list when the initial list was established. The conditions of use of ‘Calcium L-Methylfolate’ in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (5), that were included in the Union list, erroneously excluded infants and young children from the targeted users’ group, whereas the original authorisation did authorise that use. Therefore, a correction of the entry ‘Calcium L-Methylfolate’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary. |
| --- | --- |

(5)

Commission Implementing Regulation (EU) 2021/1318 (4) corrected the Union list of authorised novel foods to include the novel food ‘Calcium L-Methylfolate’ which, although authorised in January 2008 by the Irish competent authority under certain conditions of use in accordance with Regulation (EC) No 258/97, was erroneously not included in the Union list when the initial list was established. The conditions of use of ‘Calcium L-Methylfolate’ in food supplements as defined in Directive 2002/46/EC of the European Parliament and of the Council (5), that were included in the Union list, erroneously excluded infants and young children from the targeted users’ group, whereas the original authorisation did authorise that use. Therefore, a correction of the entry ‘Calcium L-Methylfolate’ in Table 1 of the Annex to Implementing Regulation (EU) 2017/2470 is necessary.

| (6) | The specification limits for mercury (≤ 1,0 mg/kg) and platinum (≤ 2 mg/kg) for ‘Calcium L-Methylfolate’ laid down in Implementing Regulation (EU) 2021/1318 refer to the limits in the specifications of this novel food authorised as a source of folate in infant formula, follow-on formula, processed cereal-based food and baby food by Commission Delegated Regulation (EU) 2021/571 (6). However, the specification limits of ≤ 1,5 mg/kg for mercury and ≤ 10 mg/kg for platinum were also originally authorised by the Irish competent authority in 2008, based on a favourable opinion on the safety of the novel food by the European Food Safety Authority (7). It is therefore necessary to correct Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 accordingly. |
| --- | --- |

(6)

The specification limits for mercury (≤ 1,0 mg/kg) and platinum (≤ 2 mg/kg) for ‘Calcium L-Methylfolate’ laid down in Implementing Regulation (EU) 2021/1318 refer to the limits in the specifications of this novel food authorised as a source of folate in infant formula, follow-on formula, processed cereal-based food and baby food by Commission Delegated Regulation (EU) 2021/571 (6). However, the specification limits of ≤ 1,5 mg/kg for mercury and ≤ 10 mg/kg for platinum were also originally authorised by the Irish competent authority in 2008, based on a favourable opinion on the safety of the novel food by the European Food Safety Authority (7). It is therefore necessary to correct Table 2 of the Annex to Implementing Regulation (EU) 2017/2470 accordingly.

| (7) | Implementing Regulation (EU) 2017/2470 containing Union list of novel foods should be corrected accordingly. |
| --- | --- |

(7)

Implementing Regulation (EU) 2017/2470 containing Union list of novel foods should be corrected accordingly.

HAS ADOPTED THIS REGULATION:

Article 1

The Annex to Implementing Regulation (EU) 2017/2470 is corrected 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.

Done at Brussels, 14 February 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 327, 11.12.2015, p. 1.

1

(2)  Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1).

2

(3)  Commission Implementing Regulation (EU) 2017/2470 of 20 December 2017 establishing the Union list of novel foods in accordance with Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (OJ L 351, 30.12.2017, p. 72).

3

(4)  Commission Implementing Regulation (EU) 2021/1318 of 9 August 2021 correcting Implementing Regulation (EU) 2017/2470 establishing the Union list of novel foods, Decision 2008/968/EC authorising the placing on the market of arachidonic acid-rich oil from Mortierella alpina as a novel food ingredient and Implementing Regulation (EU) 2020/484 authorising the placing on the market of lacto-N-tetraose as a novel food (OJ L 286, 10.8.2021, p. 5).

4

Mortierella alpina

(5)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ L 183, 12.7.2002, p. 51).

5

(6)  Commission Delegated Regulation (EU) 2021/571 of 20 January 2021 amending the Annex to Regulation (EU) No 609/2013 of the European Parliament and of the Council as regards the list of substances that may be added to infant and follow-on formula, baby food and processed cereal-based food (OJ L 120, 8.4.2021, p. 1).

6

(7)  The EFSA Journal (2004) 135, 1-20.

7

---

ANNEX

The Annex to Implementing Regulation (EU) 2017/2470 is corrected as follows:

| (1) | the entry for ‘Calcium L-Methylfolate’ is replaced by the following:






  (a) | in Table 1 (Authorised novel foods):









  Authorised novel food | Conditions under which the novel food may be used | Additional specific labelling requirements | Other requirements |
| --- | --- | --- | --- | --- | --- |
| ‘Calcium L-Methylfolate | Specified food category | Maximum levels (expressed as folic acid) | The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Calcium L-Methylfolate’.’ | |
| Foods for special medical purposes and total diet replacement for weight control as defined in Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 |
| Infant formulae and follow-on formula as defined by Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 |
| Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013 | In accordance with Regulation (EU) No 609/2013 |
| Food supplements as defined in Directive 2002/46/EC | In accordance with Directive 2002/46/EC |
| Food fortified in accordance with Regulation (EC) No 1925/2006 | In accordance with Regulation (EC) No 1925/2006 |

(1)

the entry for ‘Calcium L-Methylfolate’ is replaced by the following:

(a)

in Table 1 (Authorised novel foods):

Authorised novel food

Conditions under which the novel food may be used

Additional specific labelling requirements

Other requirements

‘Calcium L-Methylfolate

Specified food category

Maximum levels (expressed as folic acid)

The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘Calcium L-Methylfolate’.’

Foods for special medical purposes and total diet replacement for weight control as defined in Regulation (EU) No 609/2013

In accordance with Regulation (EU) No 609/2013

Infant formulae and follow-on formula as defined by Regulation (EU) No 609/2013

In accordance with Regulation (EU) No 609/2013

Processed cereal-based foods and baby foods for infants and young children as defined by Regulation (EU) No 609/2013

In accordance with Regulation (EU) No 609/2013

Food supplements as defined in Directive 2002/46/EC

In accordance with Directive 2002/46/EC

Food fortified in accordance with Regulation (EC) No 1925/2006

In accordance with Regulation (EC) No 1925/2006

and

| (b) | in Table 2 (Specifications):







  Authorised Novel Food | Specifications |
| --- | --- | --- |
| ‘Calcium L-Methylfolate | Description:

  The novel food is produced by chemical synthesis starting from folic acid.
  It is a white to light yellowish, almost odourless, crystalline powder, sparingly soluble in water and very slightly soluble or insoluble in most organic solvents.

  Definition:

  Chemical formula: C20H23CaN7O6

  Systematic name: N-{4-[[((6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl)methyl]amino]benzoyl}-L-glutamic acid, calcium salt.
  CAS Numbers: 129025-21-4 (Calcium salt with an unspecified ratio of L-5-MTHF/Ca2+) and 151533-22-1 (Calcium salt with specified 1:1 ratio of L-5-MTHF/Ca2+).
  Molecular weight: 497,5 Daltons
  Synonyms: L-methylfolate, calcium; L-5-methyltetrahydrofolic acid, calcium salt [(L-5-MTHF-Ca)]; (6S)-5-methyltetrahydrofolic acid, calcium salt [(6S)-5-MTHF-Ca]; (6S)-5-methyl-5,6,7,8-tetrahydropteroyl-L-glutamic acid, calcium salt, and L-5-methyl-tetrahydrofolic acid (L-5-MTHF) without the cation specified.
  Structural formula:






  Characteristics

  Purity: > 95 % (Dry basis)
  Water: ≤ 17,0 %
  Calcium (on anhydrous and solvent free basis): 7,0 – 8,5 %
  Calcium D-methylfolate (6R, αS isomer): ≤ 1,0 %
  Other folates and related substances: ≤ 2,5 %
  Ethanol: ≤ 0,5 %

  Contaminants |
| Infants and young children | General population excluding infants and young children |
| Lead: ≤ 1 mg/kg | Lead: ≤ 1 mg/kg |
| Boron: ≤ 10 mg/kg | Boron: ≤ 10 mg/kg |
| Cadmium ≤ 0,5 mg/kg | Cadmium ≤ 0,5 mg/kg |
| Mercury ≤ 1,0 mg/kg | Mercury ≤ 1,5 mg/kg |
| Arsenic ≤ 1,5 mg/kg | Arsenic ≤ 1,5 mg/kg |
| Platinum ≤ 2 mg/kg | Platinum ≤ 10 mg/kg |
| Microbiological criteria:

  Total viable aerobic counts: ≤ 1 000 CFU/g
  Total yeast and mould count: ≤ 100 CFU/g |
| CFU: Colony Forming Units’ |

(b)

in Table 2 (Specifications):

Authorised Novel Food

Specifications

‘Calcium L-Methylfolate

Description:

The novel food is produced by chemical synthesis starting from folic acid.

It is a white to light yellowish, almost odourless, crystalline powder, sparingly soluble in water and very slightly soluble or insoluble in most organic solvents.

Definition:

Chemical formula: C20H23CaN7O6

Systematic name: N-{4-[[((6S)-2-amino-1,4,5,6,7,8-hexahydro-5-methyl-4-oxo-6-pteridinyl)methyl]amino]benzoyl}-L-glutamic acid, calcium salt.

CAS Numbers: 129025-21-4 (Calcium salt with an unspecified ratio of L-5-MTHF/Ca2+) and 151533-22-1 (Calcium salt with specified 1:1 ratio of L-5-MTHF/Ca2+).

Molecular weight: 497,5 Daltons

Synonyms: L-methylfolate, calcium; L-5-methyltetrahydrofolic acid, calcium salt [(L-5-MTHF-Ca)]; (6S)-5-methyltetrahydrofolic acid, calcium salt [(6S)-5-MTHF-Ca]; (6S)-5-methyl-5,6,7,8-tetrahydropteroyl-L-glutamic acid, calcium salt, and L-5-methyl-tetrahydrofolic acid (L-5-MTHF) without the cation specified.

Structural formula:

Image 1

Characteristics

Purity: > 95 % (Dry basis)

Water: ≤ 17,0 %

Calcium (on anhydrous and solvent free basis): 7,0 – 8,5 %

Calcium D-methylfolate (6R, αS isomer): ≤ 1,0 %

Other folates and related substances: ≤ 2,5 %

Ethanol: ≤ 0,5 %

Contaminants

Infants and young children

General population excluding infants and young children

Lead: ≤ 1 mg/kg

Lead: ≤ 1 mg/kg

Boron: ≤ 10 mg/kg

Boron: ≤ 10 mg/kg

Cadmium ≤ 0,5 mg/kg

Cadmium ≤ 0,5 mg/kg

Mercury ≤ 1,0 mg/kg

Mercury ≤ 1,5 mg/kg

Arsenic ≤ 1,5 mg/kg

Arsenic ≤ 1,5 mg/kg

Platinum ≤ 2 mg/kg

Platinum ≤ 10 mg/kg

Microbiological criteria:

Total viable aerobic counts: ≤ 1 000 CFU/g

Total yeast and mould count: ≤ 100 CFU/g

CFU: Colony Forming Units’

| (2) | the entry for ‘Cistus incanus L. Pandalis herb’ in Table 2 (Specifications) is replaced by the following:






  Authorised Novel Food | Specifications |
| --- | --- | --- |
| ‘
  Cistus incanus L. Pandalis herb’ | Description:


  Cistus incanus L. Pandalis herb; species belonging to the Cistaceae family and native to the Mediterranean region, Chalkidiki Peninsula.
  The novel food consists of the dried and cut aerial parts (young shoots with woody parts) of Cistus incanus L. Pandalis’ |

(2)

the entry for ‘Cistus incanus L. Pandalis herb’ in Table 2 (Specifications) is replaced by the following:

Authorised Novel Food

Specifications

‘
  Cistus incanus L. Pandalis herb’

Description:

Cistus incanus L. Pandalis herb; species belonging to the Cistaceae family and native to the Mediterranean region, Chalkidiki Peninsula.

The novel food consists of the dried and cut aerial parts (young shoots with woody parts) of Cistus incanus L. Pandalis’

---

| 15.2.2022 | EN | Official Journal of the European Union | L 33/46 |
| --- | --- | --- | --- |

15.2.2022

EN

Official Journal of the European Union

L 33/46

---

COMMISSION IMPLEMENTING REGULATION (EU) 2022/203

of 14 February 2022

amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by competent authorities, and correcting Regulation (EU) No 748/2012 as regards the issuance of airworthiness review certificates

THE EUROPEAN COMMISSION,

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

Having regard to 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 (1), and in particular Article 62(14) and (15) thereof,

Whereas:

| (1) | Commission Regulation (EU) No 748/2012 (2) lays down common technical requirements for the design and production of civil aircraft, as well as engines, propellers and parts to be installed therein. |
| --- | --- |

(1)

Commission Regulation (EU) No 748/2012 (2) lays down common technical requirements for the design and production of civil aircraft, as well as engines, propellers and parts to be installed therein.

| (2) | In accordance with point 3.1(b) of Annex II to Regulation (EU) 2018/1139, approved organisations that design and produce civil aircraft, as well as engines, propellers and parts to be installed therein must, as appropriate to the type of activity undertaken and the size of the organisation, implement and maintain a management system to ensure compliance with the essential requirements set out in that Annex, manage safety risks and aim for the continuous improvement of that system. |
| --- | --- |

(2)

In accordance with point 3.1(b) of Annex II to Regulation (EU) 2018/1139, approved organisations that design and produce civil aircraft, as well as engines, propellers and parts to be installed therein must, as appropriate to the type of activity undertaken and the size of the organisation, implement and maintain a management system to ensure compliance with the essential requirements set out in that Annex, manage safety risks and aim for the continuous improvement of that system.

| (3) | Pursuant to Annex 19 to the Convention on International Civil Aviation, signed in Chicago on 7 December 1944 (‘the Chicago Convention’), competent authorities are to require approved design and production organisations to implement a safety management system. |
| --- | --- |

(3)

Pursuant to Annex 19 to the Convention on International Civil Aviation, signed in Chicago on 7 December 1944 (‘the Chicago Convention’), competent authorities are to require approved design and production organisations to implement a safety management system.

| (4) | Therefore, a management system should be introduced for all approved design and production organisations falling within the scope of Annex I to Regulation (EU) No 748/2012 in order to comply with the International Civil Aviation Organisation (‘ICAO’) International Standards and Recommended Practices established in Annex 19 to the Chicago Convention. |
| --- | --- |

(4)

Therefore, a management system should be introduced for all approved design and production organisations falling within the scope of Annex I to Regulation (EU) No 748/2012 in order to comply with the International Civil Aviation Organisation (‘ICAO’) International Standards and Recommended Practices established in Annex 19 to the Chicago Convention.

| (5) | All approved design and production organisations are required to establish an occurrence reporting system. Therefore, the provisions of Annex I to Regulation (EU) No 748/2012 should be amended to ensure that the occurrence reporting system is established as part of the organisations’ management system and that the requirements are aligned with those of Regulation (EU) No 376/2014 of the European Parliament and of the Council (3). |
| --- | --- |

(5)

All approved design and production organisations are required to establish an occurrence reporting system. Therefore, the provisions of Annex I to Regulation (EU) No 748/2012 should be amended to ensure that the occurrence reporting system is established as part of the organisations’ management system and that the requirements are aligned with those of Regulation (EU) No 376/2014 of the European Parliament and of the Council (3).

| (6) | A sufficient transition period should allow design and production organisations to ensure their compliance with the new rules and procedures introduced by this Regulation. |
| --- | --- |

(6)

A sufficient transition period should allow design and production organisations to ensure their compliance with the new rules and procedures introduced by this Regulation.

| (7) | Regulation (EU) No 748/2012 should therefore be amended. |
| --- | --- |

(7)

Regulation (EU) No 748/2012 should therefore be amended.

| (8) | Commission Delegated Regulation (EU) 2021/699 (4) replaced point (c) of point 21.B.325 to establish in which cases the competent authority of the Member State of registry, in addition to the airworthiness certificate referred to in points (a) and (b) of point 21.B.325, should also issue an airworthiness review certificate considering whether Part-M or Part-ML of Commission Regulation (EU) No 1321/2014 (5) was applicable to the aircraft at stake. The adopted text however did not properly address the case of new aircraft. Regulation (EU) No 748/2012 should therefore be corrected. |
| --- | --- |

(8)

Commission Delegated Regulation (EU) 2021/699 (4) replaced point (c) of point 21.B.325 to establish in which cases the competent authority of the Member State of registry, in addition to the airworthiness certificate referred to in points (a) and (b) of point 21.B.325, should also issue an airworthiness review certificate considering whether Part-M or Part-ML of Commission Regulation (EU) No 1321/2014 (5) was applicable to the aircraft at stake. The adopted text however did not properly address the case of new aircraft. Regulation (EU) No 748/2012 should therefore be corrected.

| (9) | The measures provided for in this Regulation are in accordance with Opinion No 04/2020 (6), of the European Union Aviation Safety Agency, submitted pursuant to Article 76(1) of Regulation (EU) 2018/1139. |
| --- | --- |

(9)

The measures provided for in this Regulation are in accordance with Opinion No 04/2020 (6), of the European Union Aviation Safety Agency, submitted pursuant to Article 76(1) of Regulation (EU) 2018/1139.

| (10) | The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 127(1) of Regulation (EU) 2018/1139, |
| --- | --- |

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 127(1) of Regulation (EU) 2018/1139,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EU) No 748/2012 is amended as follows:

| (1) | in Article 9, the following paragraphs are added:

  ‘5.   By way of derogation from points 21.B.225(d)(1) and (2) of Annex I (Part 21), a production organisation that holds a valid approval certificate issued in accordance with Annex I (Part 21) may correct, until 7 March 2025, any findings of non-compliance related to the Annex I requirements introduced by Commission Implementing Regulation (EU) 2022/203 (*1).
  Where after 7 March 2025 the organisation has not closed those findings, the approval certificate shall be revoked, limited or suspended in whole or in part.


  6.   By way of derogation from points 21.B.125(d)(1) and (2) of Annex I (Part 21), an organisation that produces products, parts or appliances without an approval certificate and that holds a valid letter of agreement issued in accordance with Annex I (Part 21) may correct, until 7 March 2025, any findings of non-compliance related to the Annex I requirements introduced by Implementing Regulation (EU) 2022/203.
  Where after 7 March 2025 the organisation has not closed those findings, the letter of agreement shall be revoked, limited or suspended in whole or in part.


  (*1)  Commission Implementing Regulation (EU) 2022/203 of 14 February 2022 amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by competent authorities, and correcting Regulation (EU) No 748/2012 as regards the issuance of airworthiness review certificates (OJ L 33, 15.2.2022, p. 46
  ’
  " |
| --- | --- |

(1)

in Article 9, the following paragraphs are added:

‘5.   By way of derogation from points 21.B.225(d)(1) and (2) of Annex I (Part 21), a production organisation that holds a valid approval certificate issued in accordance with Annex I (Part 21) may correct, until 7 March 2025, any findings of non-compliance related to the Annex I requirements introduced by Commission Implementing Regulation (EU) 2022/203 (*1).

Where after 7 March 2025 the organisation has not closed those findings, the approval certificate shall be revoked, limited or suspended in whole or in part.

6.   By way of derogation from points 21.B.125(d)(1) and (2) of Annex I (Part 21), an organisation that produces products, parts or appliances without an approval certificate and that holds a valid letter of agreement issued in accordance with Annex I (Part 21) may correct, until 7 March 2025, any findings of non-compliance related to the Annex I requirements introduced by Implementing Regulation (EU) 2022/203.

Where after 7 March 2025 the organisation has not closed those findings, the letter of agreement shall be revoked, limited or suspended in whole or in part.

(*1)  Commission Implementing Regulation (EU) 2022/203 of 14 February 2022 amending Regulation (EU) No 748/2012 as regards management systems and occurrence-reporting systems to be established by competent authorities, and correcting Regulation (EU) No 748/2012 as regards the issuance of airworthiness review certificates (OJ L 33, 15.2.2022, p. 46
  ’
  "

*1

| (2) | Annex I is amended in accordance with Annex I to this Regulation. |
| --- | --- |

(2)

Annex I is amended in accordance with Annex I to this Regulation.

Article 2

Annex I to Regulation (EU) No 748/2012 is corrected in accordance with Annex II to this Regulation.

Article 3

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 7 March 2023, with the exception of Article 2 which shall apply from 7 March 2022.

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

Done at Brussels, 14 February 2022.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  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

(3)  Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis and follow-up of occurrences in civil aviation, amending Regulation (EU) No 996/2010 of the European Parliament and of the Council and repealing Directive 2003/42/EC of the European Parliament and of the Council and Commission Regulations (EC) No 1321/2007 and (EC) No 1330/2007 (OJ L 122, 24.4.2014, p. 18).

3

(4)  Commission Delegated Regulation (EU) 2021/699 of 21 December 2020 amending and correcting Regulation (EU) No 748/2012 as regards the instructions for continued airworthiness, the production of parts to be used during maintenance and the consideration of ageing aircraft aspects during certification (OJ L 145, 28.4.2021, p. 1)

4

(5)  Commission Regulation (EU) No 1321/2014 of 26 November 2014 on the continuing airworthiness of aircraft and aeronautical products, parts and appliances, and on the approval of organisations and personnel involved in these tasks (OJ L 362, 17.12.2014, p. 1).

5

(6)  https://www.easa.europa.eu/document-library/opinions

6

---

ANNEX I

Part 21 of Annex I to Regulation (EU) No 748/2012 is amended as follows:

| (1) | point 21.1 is replaced by the following:
  ‘21.1.   Competent authority

  For the purpose of this Annex, the ‘competent authority’ shall be:






  (a) | for Section A, Subpart A,






  1. | for design organisations, the Agency; |
| --- | --- | --- | --- |

(1)

point 21.1 is replaced by the following:

‘21.1.   Competent authority

For the purpose of this Annex, the ‘competent authority’ shall be:

(a)

for Section A, Subpart A,

1.

for design organisations, the Agency;

| 2. | for production organisations that have their principal place of business in a territory for which a Member State is responsible under the Convention on International Civil Aviation, signed in Chicago on 7 December 1944 (‘the Chicago Convention’), the authority designated by that Member State or by another Member State in accordance with Article 64 of Regulation (EU) 2018/1139, or the Agency if the responsibility has been reallocated to the Agency in accordance with Article 64 or 65 of Regulation (EU) 2018/1139; |
| --- | --- |

2.

for production organisations that have their principal place of business in a territory for which a Member State is responsible under the Convention on International Civil Aviation, signed in Chicago on 7 December 1944 (‘the Chicago Convention’), the authority designated by that Member State or by another Member State in accordance with Article 64 of Regulation (EU) 2018/1139, or the Agency if the responsibility has been reallocated to the Agency in accordance with Article 64 or 65 of Regulation (EU) 2018/1139;

| 3. | for production organisations that have their principal place of business outside a territory for which a Member State is responsible under the Chicago Convention, the Agency; |
| --- | --- |

3.

for production organisations that have their principal place of business outside a territory for which a Member State is responsible under the Chicago Convention, the Agency;

| (b) | for Section A, Subparts B, D, E, J, K, M, O and Q, the Agency; |
| --- | --- |

(b)

for Section A, Subparts B, D, E, J, K, M, O and Q, the Agency;

| (c) | for Section A, Subparts F and G:






  1. | for natural or legal persons that have their principal place of business in a territory for which a Member State is responsible under the Chicago Convention, the authority designated by that Member State or by another Member State in accordance with Article 64 of Regulation (EU) 2018/1139, or the Agency if the responsibility has been reallocated to the Agency in accordance with Article 64 or, as regards Subpart G, Article 65 of Regulation (EU) 2018/1139; |
| --- | --- | --- |

(c)

for Section A, Subparts F and G:

1.

for natural or legal persons that have their principal place of business in a territory for which a Member State is responsible under the Chicago Convention, the authority designated by that Member State or by another Member State in accordance with Article 64 of Regulation (EU) 2018/1139, or the Agency if the responsibility has been reallocated to the Agency in accordance with Article 64 or, as regards Subpart G, Article 65 of Regulation (EU) 2018/1139;

| 2. | for natural or legal persons that have their principal place of business outside a territory for which a Member State is responsible under the Chicago Convention, the Agency; |
| --- | --- |

2.

for natural or legal persons that have their principal place of business outside a territory for which a Member State is responsible under the Chicago Convention, the Agency;

| (d) | for Section A, Subpart H and I, the authority designated by the Member State where the aircraft is registered or will be registered: |
| --- | --- |

(d)

for Section A, Subpart H and I, the authority designated by the Member State where the aircraft is registered or will be registered:

| (e) | for Section A, Subpart P:






  1. | for aircraft registered in a Member State, the authority designated by the Member State of registry; |
| --- | --- | --- |

(e)

for Section A, Subpart P:

1.

for aircraft registered in a Member State, the authority designated by the Member State of registry;

| 2. | for unregistered aircraft, the authority designated by the Member State which prescribed the identification marks; |
| --- | --- |

2.

for unregistered aircraft, the authority designated by the Member State which prescribed the identification marks;

| 3. | for the approval of the flight conditions related to the safety of the design, the Agency.’; |
| --- | --- |

3.

for the approval of the flight conditions related to the safety of the design, the Agency.’;

| (2) | the following point 21.2 is added:
  ‘21.2.   Scope

  Section A of this Annex establishes the provisions that lay down the rights and obligations of the applicant for, and holder of, any certificate issued or to be issued in accordance with this Annex.
  Section B of this Annex establishes the conditions for conducting the certification oversight and enforcement tasks as well as the administrative and management system requirements to be complied with by the competent authority that is responsible for the implementation of Section A of this Annex.’; |
| --- | --- |

(2)

the following point 21.2 is added:

‘21.2.   Scope

Section A of this Annex establishes the provisions that lay down the rights and obligations of the applicant for, and holder of, any certificate issued or to be issued in accordance with this Annex.

Section B of this Annex establishes the conditions for conducting the certification oversight and enforcement tasks as well as the administrative and management system requirements to be complied with by the competent authority that is responsible for the implementation of Section A of this Annex.’;

| (3) | point 21.B.5 is deleted; |
| --- | --- |

(3)

point 21.B.5 is deleted;

| (4) | the following points 21.B.10 and 21.B.15 are added:
  ‘21.B.10   Oversight documentation

  The competent authority shall provide all the legislative acts, standards, rules, technical publications and related documents to the relevant personnel in order to allow them to perform their tasks and to discharge their responsibilities.
  21.B.15   Information to the Agency







  (a) | The competent authority of the Member State shall notify the Agency in case of any significant problems with the implementation of Regulation (EU) 2018/1139 and its delegated and implementing acts within 30 days from the time the competent authority became aware of the problem. |
| --- | --- | --- |

(4)

the following points 21.B.10 and 21.B.15 are added:

‘21.B.10   Oversight documentation

The competent authority shall provide all the legislative acts, standards, rules, technical publications and related documents to the relevant personnel in order to allow them to perform their tasks and to discharge their responsibilities.

21.B.15   Information to the Agency

(a)

The competent authority of the Member State shall notify the Agency in case of any significant problems with the implementation of Regulation (EU) 2018/1139 and its delegated and implementing acts within 30 days from the time the competent authority became aware of the problem.

| (b) | Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, the competent authority of the Member State shall provide the Agency as soon as possible with any safety-significant information stemming from the occurrence reports stored in the national database pursuant to Article 6(6) of Regulation (EU) No 376/2014.’; |
| --- | --- |

(b)

Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, the competent authority of the Member State shall provide the Agency as soon as possible with any safety-significant information stemming from the occurrence reports stored in the national database pursuant to Article 6(6) of Regulation (EU) No 376/2014.’;

| (5) | point 21.B.20 is replaced by the following:
  ‘21.B.20   Immediate reaction to a safety problem







  (a) | Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, the competent authority shall implement a system to appropriately collect, analyse and disseminate safety information. |
| --- | --- | --- |

(5)

point 21.B.20 is replaced by the following:

‘21.B.20   Immediate reaction to a safety problem

(a)

Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council and its delegated and implementing acts, the competent authority shall implement a system to appropriately collect, analyse and disseminate safety information.

| (b) | The Agency shall implement a system to appropriately analyse any relevant safety information received and, without undue delay, provide the relevant authority of the Member States and the Commission with any information, including recommendations or corrective actions to be taken, that is necessary for them to react in a timely manner to a safety problem involving products, parts, appliances, persons or organisations that are subject to Regulation (EU) 2018/1139 and its delegated and implementing acts. |
| --- | --- |

(b)

The Agency shall implement a system to appropriately analyse any relevant safety information received and, without undue delay, provide the relevant authority of the Member States and the Commission with any information, including recommendations or corrective actions to be taken, that is necessary for them to react in a timely manner to a safety problem involving products, parts, appliances, persons or organisations that are subject to Regulation (EU) 2018/1139 and its delegated and implementing acts.

| (c) | Upon receiving the information referred to in points (a) and (b), the competent authority shall take adequate measures to address the safety problem. |
| --- | --- |

(c)

Upon receiving the information referred to in points (a) and (b), the competent authority shall take adequate measures to address the safety problem.

| (d) | The competent authority shall immediately notify measures taken under point (c) to all persons or organisations which need to comply with them under Regulation (EU) 2018/1139 and its delegated and implementing acts. The competent authority of the Member State shall also notify those measures to the Agency and, when combined action is required, to the other Member States concerned.’; |
| --- | --- |

(d)

The competent authority shall immediately notify measures taken under point (c) to all persons or organisations which need to comply with them under Regulation (EU) 2018/1139 and its delegated and implementing acts. The competent authority of the Member State shall also notify those measures to the Agency and, when combined action is required, to the other Member States concerned.’;

| (6) | point 21.B.25 is replaced by the following:
  ‘21.B.25   Management system







  (a) | The competent authority shall establish and maintain a management system, including as a minimum:






  1. | documented policies and procedures to describe its organisation, the means and methods for establishing compliance with Regulation (EU) 2018/1139 and its delegated and implementing acts. The procedures shall be kept up to date, and serve as the basic working documents within that competent authority for all its related tasks; |
| --- | --- | --- | --- |

(6)

point 21.B.25 is replaced by the following:

‘21.B.25   Management system

(a)

The competent authority shall establish and maintain a management system, including as a minimum:

1.

documented policies and procedures to describe its organisation, the means and methods for establishing compliance with Regulation (EU) 2018/1139 and its delegated and implementing acts. The procedures shall be kept up to date, and serve as the basic working documents within that competent authority for all its related tasks;

| 2. | a sufficient number of personnel to perform its tasks and discharge its responsibilities. A system shall be in place to plan the availability of personnel in order to ensure the proper completion of all tasks; |
| --- | --- |

2.

a sufficient number of personnel to perform its tasks and discharge its responsibilities. A system shall be in place to plan the availability of personnel in order to ensure the proper completion of all tasks;

| 3. | personnel that are qualified to perform their allocated tasks and that have the necessary knowledge and experience, and receive initial and recurrent training to ensure continuing competency; |
| --- | --- |

3.

personnel that are qualified to perform their allocated tasks and that have the necessary knowledge and experience, and receive initial and recurrent training to ensure continuing competency;

| 4. | adequate facilities and office accommodation for personnel to perform their allocated tasks; |
| --- | --- |

4.

adequate facilities and office accommodation for personnel to perform their allocated tasks;

| 5. | a function to monitor the compliance of the management system with the relevant requirements, and the adequacy of the procedures, including the establishment of an internal audit process and a safety risk management process. Compliance monitoring shall include a feedback system of audit findings to the senior management of the competent authority to ensure the implementation of corrective actions as necessary; |
| --- | --- |

5.

a function to monitor the compliance of the management system with the relevant requirements, and the adequacy of the procedures, including the establishment of an internal audit process and a safety risk management process. Compliance monitoring shall include a feedback system of audit findings to the senior management of the competent authority to ensure the implementation of corrective actions as necessary;

| 6. | a person or group of persons having a responsibility to the senior management of the competent authority for the compliance monitoring function. |
| --- | --- |

6.

a person or group of persons having a responsibility to the senior management of the competent authority for the compliance monitoring function.

| (b) | The competent authority shall, for each field of activity, including the management system, appoint one or more persons with the overall responsibility for the management of the relevant task(s). |
| --- | --- |

(b)

The competent authority shall, for each field of activity, including the management system, appoint one or more persons with the overall responsibility for the management of the relevant task(s).

| (c) | The competent authority shall establish procedures for the participation in a mutual exchange of all necessary information and assistance with any other competent authorities concerned, whether from the same Member State or from other Member States, including on:






  1. | all findings raised and any follow-up actions taken as a result of the oversight of persons and organisations that carry out activities in the territory of a Member State, but certified by the competent authority of another Member State or by the Agency; |
| --- | --- | --- |

(c)

The competent authority shall establish procedures for the participation in a mutual exchange of all necessary information and assistance with any other competent authorities concerned, whether from the same Member State or from other Member States, including on:

1.

all findings raised and any follow-up actions taken as a result of the oversight of persons and organisations that carry out activities in the territory of a Member State, but certified by the competent authority of another Member State or by the Agency;

| 2. | information stemming from mandatory and voluntary occurrence reporting as required by 21.A.3A. |
| --- | --- |

2.

information stemming from mandatory and voluntary occurrence reporting as required by 21.A.3A.

| (d) | A copy of the procedures related to the management system of the competent authority of the Member State and their amendments shall be made available to the Agency for the purpose of standardisation.’; |
| --- | --- |

(d)

A copy of the procedures related to the management system of the competent authority of the Member State and their amendments shall be made available to the Agency for the purpose of standardisation.’;

| (7) | point 21.B.30 is replaced by the following:
  ‘21.B.30   Allocation of tasks to qualified entities







  (a) | The competent authority may allocate tasks related to the initial certification or to the continuing oversight of products and parts, as well as of natural or legal persons subject to Regulation (EU) 2018/1139 and its delegated and implementing acts to qualified entities. When allocating tasks, the competent authority shall ensure that it has:






  1. | put a system in place to initially and continuously assess whether the qualified entity complies with Annex VI to Regulation (EU) 2018/1139. That system and the results of the assessments shall be documented; |
| --- | --- | --- | --- |

(7)

point 21.B.30 is replaced by the following:

‘21.B.30   Allocation of tasks to qualified entities

(a)

The competent authority may allocate tasks related to the initial certification or to the continuing oversight of products and parts, as well as of natural or legal persons subject to Regulation (EU) 2018/1139 and its delegated and implementing acts to qualified entities. When allocating tasks, the competent authority shall ensure that it has:

1.

put a system in place to initially and continuously assess whether the qualified entity complies with Annex VI to Regulation (EU) 2018/1139. That system and the results of the assessments shall be documented;

| 2. | established a written agreement with the qualified entity, approved by both parties at the appropriate management level, which stipulates:






  (i) | the tasks to be performed; |
| --- | --- | --- |

2.

established a written agreement with the qualified entity, approved by both parties at the appropriate management level, which stipulates:

(i)

the tasks to be performed;

| (ii) | the declarations, reports and records to be provided; |
| --- | --- |

(ii)

the declarations, reports and records to be provided;

| (iii) | the technical conditions to be met when performing such tasks; |
| --- | --- |

(iii)

the technical conditions to be met when performing such tasks;

| (iv) | the related liability coverage; |
| --- | --- |

(iv)

the related liability coverage;

| (v) | the protection given to the information acquired when carrying out such tasks. |
| --- | --- |

(v)

the protection given to the information acquired when carrying out such tasks.

| (b) | The competent authority shall ensure that the internal audit process and safety risk management process established pursuant to point 21.B.25(a)(5) cover all the certification and continuing oversight tasks performed by the qualified entity on its behalf.’; |
| --- | --- |

(b)

The competent authority shall ensure that the internal audit process and safety risk management process established pursuant to point 21.B.25(a)(5) cover all the certification and continuing oversight tasks performed by the qualified entity on its behalf.’;

| (8) | point 21.B.35 is replaced by the following:
  ‘21.B.35   Changes in the management system







  (a) | The competent authority shall have a system in place to identify the changes that affect its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU) 2018/1139 and its delegated and implementing acts. That system shall enable the competent authority to take action necessary to ensure that its management system remains adequate and effective. |
| --- | --- | --- |

(8)

point 21.B.35 is replaced by the following:

‘21.B.35   Changes in the management system

(a)

The competent authority shall have a system in place to identify the changes that affect its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EU) 2018/1139 and its delegated and implementing acts. That system shall enable the competent authority to take action necessary to ensure that its management system remains adequate and effective.

| (b) | The competent authority shall update in a timely manner its management system to reflect any changes to Regulation (EU) 2018/1139 and its delegated and implementing acts so as to ensure its effective implementation. |
| --- | --- |

(b)

The competent authority shall update in a timely manner its management system to reflect any changes to Regulation (EU) 2018/1139 and its delegated and implementing acts so as to ensure its effective implementation.

| (c) | The competent authority of the Member State shall notify the Agency of any changes affecting its capability to perform its tasks and discharge its responsibilities as provided for in Regulation (EU) 2018/1139 and its delegated and implementing acts.’; |
| --- | --- |

(c)

The competent authority of the Member State shall notify the Agency of any changes affecting its capability to perform its tasks and discharge its responsibilities as provided for in Regulation (EU) 2018/1139 and its delegated and implementing acts.’;

| (9) | point 21.B.40 is deleted; |
| --- | --- |

(9)

point 21.B.40 is deleted;

| (10) | point 21.B.45 is deleted; |
| --- | --- |

(10)

point 21.B.45 is deleted;

| (11) | point 21.B.55 is replaced by the following:
  ‘21.B.55   Record-keeping







  (a) | The competent authority shall establish a record-keeping system that allows the adequate storage, accessibility and reliable traceability of:






  1. | the management system’s documented policies and procedures; |
| --- | --- | --- | --- |

(11)

point 21.B.55 is replaced by the following:

‘21.B.55   Record-keeping

(a)

The competent authority shall establish a record-keeping system that allows the adequate storage, accessibility and reliable traceability of:

1.

the management system’s documented policies and procedures;

| 2. | the training, qualifications and authorisation of its personnel; |
| --- | --- |

2.

the training, qualifications and authorisation of its personnel;

| 3. | the allocation of tasks, covering the elements required by point 21.B.30, as well as the details of tasks allocated; |
| --- | --- |

3.

the allocation of tasks, covering the elements required by point 21.B.30, as well as the details of tasks allocated;

| 4. | certification processes and continuing oversight of certified organisations, including:






  (i) | the application for a certificate, approval, authorisation and letter of agreement; |
| --- | --- | --- |

4.

certification processes and continuing oversight of certified organisations, including:

(i)

the application for a certificate, approval, authorisation and letter of agreement;

| (ii) | the competent authority’s continuing oversight programme, including all the assessments, audits and inspection records; |
| --- | --- |

(ii)

the competent authority’s continuing oversight programme, including all the assessments, audits and inspection records;

| (iii) | the certificates, approvals, authorisations and letters of agreement issued, including any changes to them; |
| --- | --- |

(iii)

the certificates, approvals, authorisations and letters of agreement issued, including any changes to them;

| (iv) | a copy of the oversight programme, listing the dates when audits are due and when audits were carried out; |
| --- | --- |

(iv)

a copy of the oversight programme, listing the dates when audits are due and when audits were carried out;

| (v) | copies of all formal correspondence; |
| --- | --- |

(v)

copies of all formal correspondence;

| (vi) | recommendations for the issue or continuation of a certificate, an approval authorisation or a letter of agreement, detail of findings and actions taken by the organisations to close those findings, including the date of closure, enforcement actions and observations; |
| --- | --- |

(vi)

recommendations for the issue or continuation of a certificate, an approval authorisation or a letter of agreement, detail of findings and actions taken by the organisations to close those findings, including the date of closure, enforcement actions and observations;

| (vii) | any assessment, audit and inspection report issued by another competent authority pursuant to points 21.B.120(d), 21.B.221(c) or 21.B.431(c); |
| --- | --- |

(vii)

any assessment, audit and inspection report issued by another competent authority pursuant to points 21.B.120(d), 21.B.221(c) or 21.B.431(c);

| (viii) | copies of all the organisation expositions, handbooks or manuals, and of any amendments to them; |
| --- | --- |

(viii)

copies of all the organisation expositions, handbooks or manuals, and of any amendments to them;

| (ix) | copies of any other documents approved by the competent authority; |
| --- | --- |

(ix)

copies of any other documents approved by the competent authority;

| 5. | Statements of Conformity (EASA Form 52, see Appendix VIII) and Authorised Release Certificates (EASA Form 1, see Appendix I) that it has validated for organisations that produce products, parts or appliances without a production organisation approval certificate according to Subpart F of Section A of this Annex. |
| --- | --- |

5.

Statements of Conformity (EASA Form 52, see Appendix VIII) and Authorised Release Certificates (EASA Form 1, see Appendix I) that it has validated for organisations that produce products, parts or appliances without a production organisation approval certificate according to Subpart F of Section A of this Annex.

| (b) | The competent authority shall include in the record-keeping:






  1. | documents supporting the use of alternative means of compliance |
| --- | --- | --- |

(b)

The competent authority shall include in the record-keeping:

1.

documents supporting the use of alternative means of compliance

| 2. | safety information in accordance with point 21.B.15 and follow-up measures; |
| --- | --- |

2.

safety information in accordance with point 21.B.15 and follow-up measures;

| 3. | the use of safeguard and flexibility provisions in accordance with Articles 70, 71(1) and 76(4) of Regulation (EU) 2018/1139. |
| --- | --- |

3.

the use of safeguard and flexibility provisions in accordance with Articles 70, 71(1) and 76(4) of Regulation (EU) 2018/1139.

| (c) | The competent authority shall maintain a list of all the certificates, approvals, authorisations and letters of agreement it has issued. |
| --- | --- |

(c)

The competent authority shall maintain a list of all the certificates, approvals, authorisations and letters of agreement it has issued.

| (d) | All the records referred to in points (a), (b) and (c) shall be kept for a minimum period of 5 years, subject to applicable data protection law. |
| --- | --- |

(d)

All the records referred to in points (a), (b) and (c) shall be kept for a minimum period of 5 years, subject to applicable data protection law.

| (e) | All the records referred to in points (a), (b) and (c) shall be made available, upon request, to a competent authorities of another Member State or to the Agency.’; |
| --- | --- |

(e)

All the records referred to in points (a), (b) and (c) shall be made available, upon request, to a competent authorities of another Member State or to the Agency.’;

| (12) | point 21.B.60 is deleted; |
| --- | --- |

(12)

point 21.B.60 is deleted;

| (13) | the following point 21.B.65 is added:
  ‘21.B.65   Suspension, limitation and revocation

  The competent authority shall:






  (a) | suspend a certificate, approval, permit to fly, authorisation or letter of agreement when it considers that there are reasonable grounds that such action is necessary to prevent a credible threat to aircraft safety; |
| --- | --- | --- |

(13)

the following point 21.B.65 is added:

‘21.B.65   Suspension, limitation and revocation

The competent authority shall:

(a)

suspend a certificate, approval, permit to fly, authorisation or letter of agreement when it considers that there are reasonable grounds that such action is necessary to prevent a credible threat to aircraft safety;

| (b) | suspend, revoke or limit a certificate, approval, permit to fly, authorisation or letter of agreement if such action is required pursuant to points 21.B.125, 21.B.225 or 21.B.433; |
| --- | --- |

(b)

suspend, revoke or limit a certificate, approval, permit to fly, authorisation or letter of agreement if such action is required pursuant to points 21.B.125, 21.B.225 or 21.B.433;

| (c) | suspend or revoke a certificate of airworthiness or a noise certificate upon evidence that some of the conditions specified in points 21.A.181(a) or 21.A.211(a) are not met; |
| --- | --- |

(c)

suspend or revoke a certificate of airworthiness or a noise certificate upon evidence that some of the conditions specified in points 21.A.181(a) or 21.A.211(a) are not met;

| (d) | suspend or limit in whole or in part a certificate, approval, permit to fly, authorisation or letter of agreement if unforeseeable circumstances outside the control of the competent authority prevent its inspectors from discharging their oversight responsibilities over the oversight planning cycle.’; |
| --- | --- |

(d)

suspend or limit in whole or in part a certificate, approval, permit to fly, authorisation or letter of agreement if unforeseeable circumstances outside the control of the competent authority prevent its inspectors from discharging their oversight responsibilities over the oversight planning cycle.’;

| (14) | the following point 21.B.115 is added:
  ‘21.B.115   Means of compliance







  (a) | The Agency shall develop acceptable means of compliance (‘AMC’) that may be used to establish compliance with Regulation (EU) 2018/1139 and its delegated and implementing acts. |
| --- | --- | --- |

(14)

the following point 21.B.115 is added:

‘21.B.115   Means of compliance

(a)

The Agency shall develop acceptable means of compliance (‘AMC’) that may be used to establish compliance with Regulation (EU) 2018/1139 and its delegated and implementing acts.

| (b) | Alternative means of compliance may be used to establish compliance with this Regulation. |
| --- | --- |

(b)

Alternative means of compliance may be used to establish compliance with this Regulation.

| (c) | Competent authorities shall inform the Agency of any alternative means of compliance used by organisations under their oversight or by themselves for establishing compliance with this Regulation.’;. |
| --- | --- |

(c)

Competent authorities shall inform the Agency of any alternative means of compliance used by organisations under their oversight or by themselves for establishing compliance with this Regulation.’;.

| (15) | point 21.B.120 is replaced by the following:
  ‘21.B.120   Initial certification procedure







  (a) | Upon receiving an application for the issue of a letter of agreement for the purpose of demonstrating conformity of the individual products, parts and appliances, the competent authority shall verify the applicant’s compliance with the applicable requirements. |
| --- | --- | --- |

(15)

point 21.B.120 is replaced by the following:

‘21.B.120   Initial certification procedure

(a)

Upon receiving an application for the issue of a letter of agreement for the purpose of demonstrating conformity of the individual products, parts and appliances, the competent authority shall verify the applicant’s compliance with the applicable requirements.

| (b) | The competent authority shall record all the findings issued, closure actions as well as recommendations for the issue of the letter of agreement. |
| --- | --- |

(b)

The competent authority shall record all the findings issued, closure actions as well as recommendations for the issue of the letter of agreement.

| (c) | The competent authority shall confirm to the applicant in writing all the findings raised during the verification. For initial certification, all findings must be corrected to the satisfaction of the competent authority before the letter of agreement can be issued. |
| --- | --- |

(c)

The competent authority shall confirm to the applicant in writing all the findings raised during the verification. For initial certification, all findings must be corrected to the satisfaction of the competent authority before the letter of agreement can be issued.

| (d) | When satisfied that the applicant complies with the applicable requirements, the competent authority shall issue the letter of agreement (EASA Form 65, see Appendix XI). |
| --- | --- |

(d)

When satisfied that the applicant complies with the applicable requirements, the competent authority shall issue the letter of agreement (EASA Form 65, see Appendix XI).

| (e) | The letter of agreement shall contain the scope of the agreement, a termination date and, where applicable, the appropriate limitations. |
| --- | --- |

(e)

The letter of agreement shall contain the scope of the agreement, a termination date and, where applicable, the appropriate limitations.

| (f) | The duration of the letter of agreement shall not exceed 1 year.’; |
| --- | --- |

(f)

The duration of the letter of agreement shall not exceed 1 year.’;

| (16) | point 21.B.125 is replaced by the following:
  ‘21.B.125   Findings and corrective actions; observations







  (a) | The competent authority shall have a system in place to analyse findings for their safety significance. |
| --- | --- | --- |

(16)

point 21.B.125 is replaced by the following:

‘21.B.125   Findings and corrective actions; observations

(a)

The competent authority shall have a system in place to analyse findings for their safety significance.

| (b) | A level 1 finding shall be issued by the competent authority when any significant non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the terms of the letter of agreement which lowers safety or seriously endangers flight safety.
  Level 1 findings shall also include:






  1. | any failure to grant the competent authority access to the organisation’s facilities referred to in point 21.A.9 during normal operating hours and after two written requests; |
| --- | --- | --- |

(b)

A level 1 finding shall be issued by the competent authority when any significant non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the terms of the letter of agreement which lowers safety or seriously endangers flight safety.

Level 1 findings shall also include:

1.

any failure to grant the competent authority access to the organisation’s facilities referred to in point 21.A.9 during normal operating hours and after two written requests;

| 2. | obtaining the letter of agreement or maintaining its validity by falsification of the submitted documentary evidence; and |
| --- | --- |

2.

obtaining the letter of agreement or maintaining its validity by falsification of the submitted documentary evidence; and

| 3. | any evidence of malpractice or fraudulent use of the letter of agreement. |
| --- | --- |

3.

any evidence of malpractice or fraudulent use of the letter of agreement.

| (c) | A level 2 finding shall be issued by the competent authority when any non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the terms of the letter of agreement, which is not classified as a level 1 finding. |
| --- | --- |

(c)

A level 2 finding shall be issued by the competent authority when any non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the terms of the letter of agreement, which is not classified as a level 1 finding.

| (d) | When a finding is detected during oversight or by any other means, the competent authority shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and its delegated and implementing acts, communicate in writing the finding to the organisation and request corrective action to address the non-compliance(s) identified. Where a level 1 finding directly relates to an aircraft, the competent authority shall inform the competent authority of the Member State in which the aircraft is registered.






  1. | If there are any level 1 findings, the competent authority shall take immediate and appropriate action to prohibit or limit the activities of the organisation involved and, if appropriate, it shall take action to revoke the letter of agreement or to limit or suspend it in whole or in part, depending on the extent of the level 1 finding, until successful corrective action has been taken by the organisation. |
| --- | --- | --- |

(d)

When a finding is detected during oversight or by any other means, the competent authority shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and its delegated and implementing acts, communicate in writing the finding to the organisation and request corrective action to address the non-compliance(s) identified. Where a level 1 finding directly relates to an aircraft, the competent authority shall inform the competent authority of the Member State in which the aircraft is registered.

1.

If there are any level 1 findings, the competent authority shall take immediate and appropriate action to prohibit or limit the activities of the organisation involved and, if appropriate, it shall take action to revoke the letter of agreement or to limit or suspend it in whole or in part, depending on the extent of the level 1 finding, until successful corrective action has been taken by the organisation.

| 2. | If there are any level 2 findings, the competent authority shall:






  (i) | grant the organisation a corrective action implementation period that is appropriate to the nature of the finding, and that in any case shall initially not be more than 3 months. The period shall commence from the date of the written communication of the finding to the organisation, requesting corrective action to address the non-compliance identified. At the end of that period, and subject to the nature of the finding, the competent authority may extend the 3-month period provided that a corrective action plan has been agreed with the competent authority; |
| --- | --- | --- |

2.

If there are any level 2 findings, the competent authority shall:

(i)

grant the organisation a corrective action implementation period that is appropriate to the nature of the finding, and that in any case shall initially not be more than 3 months. The period shall commence from the date of the written communication of the finding to the organisation, requesting corrective action to address the non-compliance identified. At the end of that period, and subject to the nature of the finding, the competent authority may extend the 3-month period provided that a corrective action plan has been agreed with the competent authority;

| (ii) | assess the corrective action plan and implementation plan proposed by the organisation, and if the assessment concludes that they are sufficient to address the non-compliance, accept them; |
| --- | --- |

(ii)

assess the corrective action plan and implementation plan proposed by the organisation, and if the assessment concludes that they are sufficient to address the non-compliance, accept them;

| (iii) | if the organisation fails to submit an acceptable corrective action plan, or fails to perform the corrective action within the time period accepted or extended by the competent authority, the finding shall be raised to level 1 and action shall be taken as laid down in point (f)(1)(i). |
| --- | --- |

(iii)

if the organisation fails to submit an acceptable corrective action plan, or fails to perform the corrective action within the time period accepted or extended by the competent authority, the finding shall be raised to level 1 and action shall be taken as laid down in point (f)(1)(i).

| (e) | The competent authority may issue observations for any of the following cases not requiring level 1 or level 2 findings:






  1. | for any item whose performance has been assessed to be ineffective; |
| --- | --- | --- |

(e)

The competent authority may issue observations for any of the following cases not requiring level 1 or level 2 findings:

1.

for any item whose performance has been assessed to be ineffective;

| 2. | when it has been identified that an item has the potential to cause a non-compliance under points (b) or (c); |
| --- | --- |

2.

when it has been identified that an item has the potential to cause a non-compliance under points (b) or (c);

| 3. | when suggestions or improvements are of interest for the overall safety performance of the organisation. |
| --- | --- |

3.

when suggestions or improvements are of interest for the overall safety performance of the organisation.

The observations issued under this point shall be communicated in writing to the organisation and recorded by the competent authority.’;

| (17) | points 21.B.130, 21.B.145 and 21.B.150 are deleted; |
| --- | --- |

(17)

points 21.B.130, 21.B.145 and 21.B.150 are deleted;

| (18) | the following point 21.B.215 is added:
  ‘21.B.215   Means of compliance







  (a) | The Agency shall develop acceptable means of compliance (‘AMC’) that may be used to establish compliance with Regulation (EU) 2018/1139 and its delegated and implementing acts. |
| --- | --- | --- |

(18)

the following point 21.B.215 is added:

‘21.B.215   Means of compliance

(a)

The Agency shall develop acceptable means of compliance (‘AMC’) that may be used to establish compliance with Regulation (EU) 2018/1139 and its delegated and implementing acts.

| (b) | Alternative means of compliance may be used to establish compliance with this Regulation. |
| --- | --- |

(b)

Alternative means of compliance may be used to establish compliance with this Regulation.

| (c) | Competent authorities shall inform the Agency of any alternative means of compliance used by organisations under their oversight or by themselves for establishing compliance with this Regulation.’; |
| --- | --- |

(c)

Competent authorities shall inform the Agency of any alternative means of compliance used by organisations under their oversight or by themselves for establishing compliance with this Regulation.’;

| (19) | point 21.B.220 is replaced by the following:
  ‘21.B.220   Initial certification procedure







  (a) | Upon receiving an application for the initial issue of a production organisation approval certificate, the competent authority shall verify the applicant’s compliance with the applicable requirements. |
| --- | --- | --- |

(19)

point 21.B.220 is replaced by the following:

‘21.B.220   Initial certification procedure

(a)

Upon receiving an application for the initial issue of a production organisation approval certificate, the competent authority shall verify the applicant’s compliance with the applicable requirements.

| (b) | A meeting with the accountable manager of the applicant shall be convened at least once during the investigation for initial certification to ensure that this person understands his or her role and accountability. |
| --- | --- |

(b)

A meeting with the accountable manager of the applicant shall be convened at least once during the investigation for initial certification to ensure that this person understands his or her role and accountability.

| (c) | The competent authority shall record all the findings issued, closure actions as well as the recommendations for the issue of the production organisation approval certificate. |
| --- | --- |

(c)

The competent authority shall record all the findings issued, closure actions as well as the recommendations for the issue of the production organisation approval certificate.

| (d) | The competent authority shall confirm to the applicant in writing all the findings raised during the verification. For initial certification, all findings must be corrected to the satisfaction of the competent authority before the certificate can be issued. |
| --- | --- |

(d)

The competent authority shall confirm to the applicant in writing all the findings raised during the verification. For initial certification, all findings must be corrected to the satisfaction of the competent authority before the certificate can be issued.

| (e) | When satisfied that the applicant complies with the applicable requirements, the competent authority shall issue the production organisation approval certificate (EASA Form 55, see Appendix X). |
| --- | --- |

(e)

When satisfied that the applicant complies with the applicable requirements, the competent authority shall issue the production organisation approval certificate (EASA Form 55, see Appendix X).

| (f) | The certificate reference number shall be included on the EASA Form 55 in a manner specified by the Agency. |
| --- | --- |

(f)

The certificate reference number shall be included on the EASA Form 55 in a manner specified by the Agency.

| (g) | The certificate shall be issued for an unlimited duration. The privileges and the scope of the activities that the organisation is approved to conduct, including any limitations as applicable, shall be specified in the terms of approval attached to the certificate.’; |
| --- | --- |

(g)

The certificate shall be issued for an unlimited duration. The privileges and the scope of the activities that the organisation is approved to conduct, including any limitations as applicable, shall be specified in the terms of approval attached to the certificate.’;

| (20) | the following points 21.B.221 and 21.B.222 are added:
  ‘21.B.221   Oversight principles







  (a) | The competent authority shall verify:






  1. | compliance with the requirements that are applicable to organisations, prior to issuing the production organisation approval certificate; |
| --- | --- | --- | --- |

(20)

the following points 21.B.221 and 21.B.222 are added:

‘21.B.221   Oversight principles

(a)

The competent authority shall verify:

1.

compliance with the requirements that are applicable to organisations, prior to issuing the production organisation approval certificate;

| 2. | continued compliance with the applicable requirements of the organisations it has certified; |
| --- | --- |

2.

continued compliance with the applicable requirements of the organisations it has certified;

| 3. | the implementation of appropriate safety measures mandated by the competent authority according to points 21.B.20(c) and (d). |
| --- | --- |

3.

the implementation of appropriate safety measures mandated by the competent authority according to points 21.B.20(c) and (d).

| (b) | This verification shall:






  1. | be supported by documentation specifically intended to provide personnel responsible for oversight with guidance to perform their functions; |
| --- | --- | --- |

(b)

This verification shall:

1.

be supported by documentation specifically intended to provide personnel responsible for oversight with guidance to perform their functions;

| 2. | provide the organisations concerned with the results of oversight activities; |
| --- | --- |

2.

provide the organisations concerned with the results of oversight activities;

| 3. | be based on assessments, audits, inspections and, if needed, unannounced inspections; |
| --- | --- |

3.

be based on assessments, audits, inspections and, if needed, unannounced inspections;

| 4. | provide the competent authority with the evidence needed in case further action is required, including the measures provided for in point 21.B.225. |
| --- | --- |

4.

provide the competent authority with the evidence needed in case further action is required, including the measures provided for in point 21.B.225.

| (c) | The competent authority shall establish the scope of the oversight defined in points (a) and (b) taking into account the results of past oversight activities and the safety priorities. |
| --- | --- |

(c)

The competent authority shall establish the scope of the oversight defined in points (a) and (b) taking into account the results of past oversight activities and the safety priorities.

| (d) | If the facilities of an organisation are located in more than one State, the competent authority, as defined in point 21.1, may agree to have the oversight tasks performed by the competent authority(ies) of the Member State(s) where the facilities are located, or by the Agency for facilities that are located outside a territory for which Member States are responsible under the Chicago Convention. Any organisation that is subject to such an agreement shall be informed of its existence and of its scope. |
| --- | --- |

(d)

If the facilities of an organisation are located in more than one State, the competent authority, as defined in point 21.1, may agree to have the oversight tasks performed by the competent authority(ies) of the Member State(s) where the facilities are located, or by the Agency for facilities that are located outside a territory for which Member States are responsible under the Chicago Convention. Any organisation that is subject to such an agreement shall be informed of its existence and of its scope.

| (e) | For any oversight activities that are performed at facilities located in a Member State other than where the organisation has its principal place of business, the competent authority, as defined in point 21.1, shall inform the competent authority of that Member State before performing any on-site audit or inspection of the facilities. |
| --- | --- |

(e)

For any oversight activities that are performed at facilities located in a Member State other than where the organisation has its principal place of business, the competent authority, as defined in point 21.1, shall inform the competent authority of that Member State before performing any on-site audit or inspection of the facilities.

| (f) | The competent authority shall collect and process any information deemed necessary for performing oversight activities. |
| --- | --- |

(f)

The competent authority shall collect and process any information deemed necessary for performing oversight activities.

21.B.222   Oversight programme

| (a) | The competent authority shall establish and maintain an oversight programme covering the oversight activities required by point 21.B.221(a). |
| --- | --- |

(a)

The competent authority shall establish and maintain an oversight programme covering the oversight activities required by point 21.B.221(a).

| (b) | The oversight programme shall take into account the specific nature of the organisation, the complexity of its activities, the results of past certification and/or oversight activities, and it shall be based on the assessment of the associated risks. It shall include, within each oversight planning cycle:






  1. | assessments, audits and inspections, including, as appropriate:






  (i) | management system assessments and process audits; |
| --- | --- | --- | --- |

(b)

The oversight programme shall take into account the specific nature of the organisation, the complexity of its activities, the results of past certification and/or oversight activities, and it shall be based on the assessment of the associated risks. It shall include, within each oversight planning cycle:

1.

assessments, audits and inspections, including, as appropriate:

(i)

management system assessments and process audits;

| (ii) | product audits of a relevant sample of the products, parts and appliances that are within the scope of the organisation; |
| --- | --- |

(ii)

product audits of a relevant sample of the products, parts and appliances that are within the scope of the organisation;

| (iii) | sampling of the work performed; and |
| --- | --- |

(iii)

sampling of the work performed; and

| (iv) | unannounced inspections; |
| --- | --- |

(iv)

unannounced inspections;

| 2. | meetings convened between the accountable manager and the competent authority to ensure that both parties remain informed of all significant issues. |
| --- | --- |

2.

meetings convened between the accountable manager and the competent authority to ensure that both parties remain informed of all significant issues.

| (c) | The oversight planning cycle shall not exceed 24 months. |
| --- | --- |

(c)

The oversight planning cycle shall not exceed 24 months.

| (d) | Notwithstanding point (c), the oversight planning cycle may be extended to 36 months if the competent authority has established that during the previous 24 months:






  1. | the organisation has demonstrated that it can effectively identify aviation safety hazards and manage the associated risks; |
| --- | --- | --- |

(d)

Notwithstanding point (c), the oversight planning cycle may be extended to 36 months if the competent authority has established that during the previous 24 months:

1.

the organisation has demonstrated that it can effectively identify aviation safety hazards and manage the associated risks;

| 2. | the organisation has continuously demonstrated compliance with points 21.A.147 and 21.A.148 and it has full control over all changes to the production management system; |
| --- | --- |

2.

the organisation has continuously demonstrated compliance with points 21.A.147 and 21.A.148 and it has full control over all changes to the production management system;

| 3. | no level 1 findings have been issued; |
| --- | --- |

3.

no level 1 findings have been issued;

| 4. | all corrective actions have been implemented within the time period that was accepted or extended by the competent authority as defined in point 21.B.225. |
| --- | --- |

4.

all corrective actions have been implemented within the time period that was accepted or extended by the competent authority as defined in point 21.B.225.

Notwithstanding point (c), the oversight planning cycle may be further extended to a maximum of 48 months if, in addition to the conditions provided in points (1) to (4) above, the organisation has established, and the competent authority has approved, an effective continuous system for reporting to the competent authority on the safety performance and regulatory compliance of the organisation itself.

| (e) | The oversight planning cycle may be reduced if there is evidence that the safety performance of the organisation has decreased. |
| --- | --- |

(e)

The oversight planning cycle may be reduced if there is evidence that the safety performance of the organisation has decreased.

| (f) | The oversight programme shall include records of the dates when assessments, audits, inspections and meetings are due, and when assessments, audits, inspections and meetings have been effectively carried out. |
| --- | --- |

(f)

The oversight programme shall include records of the dates when assessments, audits, inspections and meetings are due, and when assessments, audits, inspections and meetings have been effectively carried out.

| (g) | At the completion of each oversight planning cycle, the competent authority shall issue a recommendation report on the continuation of the approval, reflecting the results of the oversight.’; |
| --- | --- |

(g)

At the completion of each oversight planning cycle, the competent authority shall issue a recommendation report on the continuation of the approval, reflecting the results of the oversight.’;

| (21) | point 21.B.225 is replaced by the following:
  ‘21.B.225   Findings and corrective actions; observations







  (a) | The competent authority shall have a system in place to analyse findings for their safety significance. |
| --- | --- | --- |

(21)

point 21.B.225 is replaced by the following:

‘21.B.225   Findings and corrective actions; observations

(a)

The competent authority shall have a system in place to analyse findings for their safety significance.

| (b) | A level 1 finding shall be issued by the competent authority when any significant non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the certificate including the terms of approval which lowers safety or seriously endangers flight safety.
  The level 1 findings shall also include:






  1. | any failure to grant the competent authority access to the organisation’s facilities referred to in point 21.A.9 during normal operating hours and after two written requests; |
| --- | --- | --- |

(b)

A level 1 finding shall be issued by the competent authority when any significant non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the certificate including the terms of approval which lowers safety or seriously endangers flight safety.

The level 1 findings shall also include:

1.

any failure to grant the competent authority access to the organisation’s facilities referred to in point 21.A.9 during normal operating hours and after two written requests;

| 2. | obtaining the production organisation approval certificate or maintaining its validity by falsification of the submitted documentary evidence; |
| --- | --- |

2.

obtaining the production organisation approval certificate or maintaining its validity by falsification of the submitted documentary evidence;

| 3. | any evidence of malpractice or fraudulent use of the production organisation approval certificate; and |
| --- | --- |

3.

any evidence of malpractice or fraudulent use of the production organisation approval certificate; and

| 4. | failure to appoint an accountable manager pursuant to point 21.A.245(a)/ |
| --- | --- |

4.

failure to appoint an accountable manager pursuant to point 21.A.245(a)/

| (c) | A level 2 finding shall be issued by the competent authority when any non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the certificate including the terms of approval, which is not classified as a level 1 finding. |
| --- | --- |

(c)

A level 2 finding shall be issued by the competent authority when any non-compliance is detected with the applicable requirements of Regulation (EU) 2018/1139 and its delegated and implementing acts, with the organisation’s procedures and manuals, or with the certificate including the terms of approval, which is not classified as a level 1 finding.

| (d) | When a finding is detected during oversight or by any other means, the competent authority shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and its delegated and implementing acts, communicate in writing the finding to the organisation and request corrective action to address the non-compliance(s) identified. Where a level 1 finding directly relates to an aircraft, the competent authority shall inform the competent authority of the Member State in which the aircraft is registered.






  1. | If there are any level 1 findings, the competent authority shall take immediate and appropriate action to prohibit or limit the activities of the organisation involved and, if appropriate, it shall take action to revoke the production organisation approval certificate or to limit or suspend it in whole or in part, depending upon the extent of the level 1 finding, until successful corrective action has been taken by the organisation. |
| --- | --- | --- |

(d)

When a finding is detected during oversight or by any other means, the competent authority shall, without prejudice to any additional action required by Regulation (EU) 2018/1139 and its delegated and implementing acts, communicate in writing the finding to the organisation and request corrective action to address the non-compliance(s) identified. Where a level 1 finding directly relates to an aircraft, the competent authority shall inform the competent authority of the Member State in which the aircraft is registered.

1.

If there are any level 1 findings, the competent authority shall take immediate and appropriate action to prohibit or limit the activities of the organisation involved and, if appropriate, it shall take action to revoke the production organisation approval certificate or to limit or suspend it in whole or in part, depending upon the extent of the level 1 finding, until successful corrective action has been taken by the organisation.

| 2. | If there are any level 2 findings, the competent authority shall:






  (i) | grant the organisation a corrective action implementation period that is appropriate to the nature of the finding, and that in any case shall initially not be more than 3 months. The period shall commence from the date of the written communication of the finding to the organisation requesting corrective action to address the non-compliance identified. At the end of this period, and subject to the nature of the finding, the competent authority may extend the 3-month period provided that a corrective action plan has been agreed by the competent authority; |
| --- | --- | --- |

2.

If there are any level 2 findings, the competent authority shall:

(i)

grant the organisation a corrective action implementation period that is appropriate to the nature of the finding, and that in any case shall initially not be more than 3 months. The period shall commence from the date of the written communication of the finding to the organisation requesting corrective action to address the non-compliance identified. At the end of this period, and subject to the nature of the finding, the competent authority may extend the 3-month period provided that a corrective action plan has been agreed by the competent authority;

| (ii) | assess the corrective action and implementation plan proposed by the organisation, and if the assessment concludes that they are sufficient to address the non-compliance, accept them; |
| --- | --- |

(ii)

assess the corrective action and implementation plan proposed by the organisation, and if the assessment concludes that they are sufficient to address the non-compliance, accept them;

| (iii) | if the organisation fails to submit an acceptable corrective action plan, or fails to perform the corrective action within the time period accepted or extended by the competent authority, the finding shall be raised to level 1 and action shall be taken as laid down in point (d)(1). |
| --- | --- |

(iii)

if the organisation fails to submit an acceptable corrective action plan, or fails to perform the corrective action within the time period accepted or extended by the competent authority, the finding shall be raised to level 1 and action shall be taken as laid down in point (d)(1).

| (e) | The competent authority may issue observations for any of the following cases not requiring level 1 or level 2 findings:






  1. | for any item whose performance has been assessed to be ineffective; or |
| --- | --- | --- |

(e)

The competent authority may issue observations for any of the following cases not requiring level 1 or level 2 findings:

1.

for any item whose performance has been assessed to be ineffective; or

| 2. | when it has been identified that an item has the potential to cause a non-compliance under points (b) or (c); or |
| --- | --- |

2.

when it has been identified that an item has the potential to cause a non-compliance under points (b) or (c); or

| 3. | when suggestions or improvements are of interest for the overall safety performance of the organisation. |
| --- | --- |

3.

when suggestions or improvements are of interest for the overall safety performance of the organisation.

The observations issued under this point shall be communicated in writing to the organisation and recorded by the competent authority.’;

| (22) | points 21.B.230 and 21.B.235 are deleted; |
| --- | --- |

(22)

points 21.B.230 and 21.B.235 are deleted;

| (23) | point 21.B.240 is replaced by the following:
  ‘21.B.240   Changes in production management system







  (a) | Upon receiving an application for a significant change to the production management system, the competent authority shall verify the organisation’s compliance with the applicable requirements of this Annex before issuing the approval. |
| --- | --- | --- |

(23)

point 21.B.240 is replaced by the following:

‘21.B.240   Changes in production management system

(a)

Upon receiving an application for a significant change to the production management system, the competent authority shall verify the organisation’s compliance with the applicable requirements of this Annex before issuing the approval.

| (b) | The competent authority shall establish the conditions under which the organisation may operate during the evaluation of a change unless the competent authority determines that the production organisation approval certificate needs to be suspended. |
| --- | --- |

(b)

The competent authority shall establish the conditions under which the organisation may operate during the evaluation of a change unless the competent authority determines that the production organisation approval certificate needs to be suspended.

| (c) | When it is satisfied that the organisation complies with the applicable requirements, the competent authority shall approve the change. |
| --- | --- |

(c)

When it is satisfied that the organisation complies with the applicable requirements, the competent authority shall approve the change.

| (d) | Without prejudice to any additional enforcement measures, if the organisation implements a significant change to the production management system without having received the approval of the competent authority pursuant to point (c), the competent authority shall consider the need to suspend, limit or revoke the organisation’s certificate. |
| --- | --- |

(d)

Without prejudice to any additional enforcement measures, if the organisation implements a significant change to the production management system without having received the approval of the competent authority pursuant to point (c), the competent authority shall consider the need to suspend, limit or revoke the organisation’s certificate.

| (e) | For non-significant changes to the production management system, the competent authority shall include the review of such changes in its continuing oversight in accordance with the principles set forth in point 21.B.221. If any non-compliance is found, the competent authority shall notify the organisation, request further changes and act in accordance with point 21.B.225.’; |
| --- | --- |

(e)

For non-significant changes to the production management system, the competent authority shall include the review of such changes in its continuing oversight in accordance with the principles set forth in point 21.B.221. If any non-compliance is found, the competent authority shall notify the organisation, request further changes and act in accordance with point 21.B.225.’;

| (24) | points 21.B.245 and 21.B.260 are deleted, |
| --- | --- |

(24)

points 21.B.245 and 21.B.260 are deleted,

| (25) | in point 21.B.325, the title is replaced by the following;
  ‘21.B.325   Issuance of airworthiness certificate’ |
| --- | --- |

(25)

in point 21.B.325, the title is replaced by the following;

‘21.B.325   Issuance of airworthiness certificate’

| (26) | points 21.B.330 and 21.B.345 are deleted, |
| --- | --- |

(26)

points 21.B.330 and 21.B.345 are deleted,

| (27) | in point 21.B.525, the title is replace by the following;
  ‘21.B.525   Issuance of a permit to fly;’ |
| --- | --- |

(27)

in point 21.B.525, the title is replace by the following;

‘21.B.525   Issuance of a permit to fly;’

| (28) | 21.B.530 and 21.B.545 are deleted. |
| --- | --- |

(28)

21.B.530 and 21.B.545 are deleted.

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ANNEX II

Part 21 of Annex I to Regulation (EU) No 748/2012 is corrected as follows:

| (1) | In point 21.B.325, point (c) is replaced by the following:






  ‘(c) | For new aircraft, and used aircraft originating from a non-member State, in addition to the appropriate airworthiness certificate referred to in point (a) or (b), the competent authority of the Member State of registry shall issue:






  1. | for aircraft subject to Annex I (Part-M) to Commission Regulation (EU) No 1321/2014, an initial airworthiness review certificate (EASA Form 15a, Appendix II); |
| --- | --- | --- | --- |

(1)

In point 21.B.325, point (c) is replaced by the following:

‘(c)

For new aircraft, and used aircraft originating from a non-member State, in addition to the appropriate airworthiness certificate referred to in point (a) or (b), the competent authority of the Member State of registry shall issue:

1.

for aircraft subject to Annex I (Part-M) to Commission Regulation (EU) No 1321/2014, an initial airworthiness review certificate (EASA Form 15a, Appendix II);

| 2. | for new aircraft subject to Annex Vb (Part-ML) to Commission Regulation (EU) No 1321/2014, an initial airworthiness review certificate (EASA Form 15c, Appendix II); |
| --- | --- |

2.

for new aircraft subject to Annex Vb (Part-ML) to Commission Regulation (EU) No 1321/2014, an initial airworthiness review certificate (EASA Form 15c, Appendix II);

| 3. | for used aircraft originating from a non-member State and subject to Annex Vb (Part-ML) to Commission Regulation (EU) No 1321/2014, an initial airworthiness review certificate (EASA Form 15c, Appendix II), when the competent authority has performed the airworthiness review.’ |
| --- | --- |

3.

for used aircraft originating from a non-member State and subject to Annex Vb (Part-ML) to Commission Regulation (EU) No 1321/2014, an initial airworthiness review certificate (EASA Form 15c, Appendix II), when the competent authority has performed the airworthiness review.’

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