# Official Journal L 332/2021

| | ISSN 1977-0677 |
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| Official Journal
  of the European Union | L 332 |
| | |
| English edition | Legislation | Volume 6421 September 2021 |

ISSN 1977-0677

Official Journal

of the European Union

L 332

English edition

Legislation

Volume 6421 September 2021

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) 2021/1686 of 7 July 2021 amending Delegated Regulation (EU) 2016/161 as regards the evaluation of notifications by national competent authorities to the Commission and the inclusion of cicatrizants with ATC code D03AX and pharmaceutical form fly larvae in the list of medicinal products that shall not bear the safety features (
  1
  ) | 1 |
| | * | Commission Implementing Regulation (EU) 2021/1687 of 14 September 2021 registering a geographical indication of a spirit drink under Article 30(2) of Regulation (EU) 2019/787 of the European Parliament and of the Council Madarasi birspálinka | 4 |
| | * | Commission Implementing Regulation (EU) 2021/1688 of 20 September 2021 amending Implementing Regulation (EU) 2020/1201 as regards the lists of host plants and specified plants, and the tests for the identification of Xylella fastidiosa | 6 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Delegated Regulation (EU) 2021/1686 of 7 July 2021 amending Delegated Regulation (EU) 2016/161 as regards the evaluation of notifications by national competent authorities to the Commission and the inclusion of cicatrizants with ATC code D03AX and pharmaceutical form fly larvae in the list of medicinal products that shall not bear the safety features (
  1
  )

1

1

*

Commission Implementing Regulation (EU) 2021/1687 of 14 September 2021 registering a geographical indication of a spirit drink under Article 30(2) of Regulation (EU) 2019/787 of the European Parliament and of the Council Madarasi birspálinka

4

*

Commission Implementing Regulation (EU) 2021/1688 of 20 September 2021 amending Implementing Regulation (EU) 2020/1201 as regards the lists of host plants and specified plants, and the tests for the identification of Xylella fastidiosa

Xylella fastidiosa

6

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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. |
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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

| 21.9.2021 | EN | Official Journal of the European Union | L 332/1 |
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21.9.2021

EN

Official Journal of the European Union

L 332/1

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COMMISSION DELEGATED REGULATION (EU) 2021/1686

of 7 July 2021

amending Delegated Regulation (EU) 2016/161 as regards the evaluation of notifications by national competent authorities to the Commission and the inclusion of cicatrizants with ATC code D03AX and pharmaceutical form fly larvae in the list of medicinal products that shall not bear the safety features

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (1), and in particular Article 54a(2), points (b) and (c), thereof,

Whereas:

| (1) | Article 54a(1) of Directive 2001/83/EC provides that medical products subject to prescription are to bear the safety features referred to in Article 54, point (o), of that Directive, unless they have been listed in accordance with the procedure pursuant to Article 54a(2), point (b), of that Directive. That list is to be established considering the risk of and the risk arising from falsification relating to medicinal products or categories of medicinal products applying the criteria set out in Article 54a(2), point (b), of Directive 2001/83/EC. |
| --- | --- |

(1)

Article 54a(1) of Directive 2001/83/EC provides that medical products subject to prescription are to bear the safety features referred to in Article 54, point (o), of that Directive, unless they have been listed in accordance with the procedure pursuant to Article 54a(2), point (b), of that Directive. That list is to be established considering the risk of and the risk arising from falsification relating to medicinal products or categories of medicinal products applying the criteria set out in Article 54a(2), point (b), of Directive 2001/83/EC.

| (2) | Article 47 of Commission Delegated Regulation (EU) 2016/161 (2) provides that where, following a notification as referred to in Article 46 of that Regulation, the Commission or a Member State considers, on the basis of casualties or hospitalisations of citizens of the Union due to exposure to falsified medicinal products, rapid action is required to protect public health, the Commission is to assess the notification without delay and at the latest within 45 days. In order to better fulfil the objective of that Article, the reference to citizens of the Union should be replaced by a reference to people in the Union as all adverse events in the Union should be considered and monitored regardless of citizenship. |
| --- | --- |

(2)

Article 47 of Commission Delegated Regulation (EU) 2016/161 (2) provides that where, following a notification as referred to in Article 46 of that Regulation, the Commission or a Member State considers, on the basis of casualties or hospitalisations of citizens of the Union due to exposure to falsified medicinal products, rapid action is required to protect public health, the Commission is to assess the notification without delay and at the latest within 45 days. In order to better fulfil the objective of that Article, the reference to citizens of the Union should be replaced by a reference to people in the Union as all adverse events in the Union should be considered and monitored regardless of citizenship.

| (3) | Article 46(2) of Delegated Regulation (EU) 2016/161 establishes that national competent authorities may inform the Commission of medicinal products which they deem not to be at risk of falsification. |
| --- | --- |

(3)

Article 46(2) of Delegated Regulation (EU) 2016/161 establishes that national competent authorities may inform the Commission of medicinal products which they deem not to be at risk of falsification.

| (4) | Annex I to Delegated Regulation (EU) 2016/161, sets out a list of medicinal products or product categories subject to prescription that shall not bear the safety features. The product category ‘cicatrizants with ATC code D03AX’ with pharmaceutical form ‘fly larvae’ is not included in that list. |
| --- | --- |

(4)

Annex I to Delegated Regulation (EU) 2016/161, sets out a list of medicinal products or product categories subject to prescription that shall not bear the safety features. The product category ‘cicatrizants with ATC code D03AX’ with pharmaceutical form ‘fly larvae’ is not included in that list.

| (5) | On 22 August 2019, the Commission received a notification from the competent German authority stating that it deemed the prescription medicinal product BioBag (ATC code D03AX and pharmaceutical form ‘fly larvae’) not to be at risk of falsification in accordance with the criteria set out in Article 54a(2), point (b), of Directive 2001/83/EC, and that the medicinal product should therefore be exempted from the requirement to bear safety features. |
| --- | --- |

(5)

On 22 August 2019, the Commission received a notification from the competent German authority stating that it deemed the prescription medicinal product BioBag (ATC code D03AX and pharmaceutical form ‘fly larvae’) not to be at risk of falsification in accordance with the criteria set out in Article 54a(2), point (b), of Directive 2001/83/EC, and that the medicinal product should therefore be exempted from the requirement to bear safety features.

| (6) | The Commission assessed the risks of and arising from falsification of the medicinal product concerned taking into account the criteria listed in Article 54a(2), point (b), of Directive 2001/83/EC. In particular, the specific characteristics and short shelf life of the pharmaceutical form fly larvae means that risk of falsification is negligible and, therefore, those criteria can be considered to be met. |
| --- | --- |

(6)

The Commission assessed the risks of and arising from falsification of the medicinal product concerned taking into account the criteria listed in Article 54a(2), point (b), of Directive 2001/83/EC. In particular, the specific characteristics and short shelf life of the pharmaceutical form fly larvae means that risk of falsification is negligible and, therefore, those criteria can be considered to be met.

| (7) | The Commission consulted the expert group ‘Delegated act on safety features for medicinal products for human use’, which noted the extremely short shelf life and the fact that the product contains living organisms (3). |
| --- | --- |

(7)

The Commission consulted the expert group ‘Delegated act on safety features for medicinal products for human use’, which noted the extremely short shelf life and the fact that the product contains living organisms (3).

| (8) | It is, therefore, appropriate to include the product category ‘cicatrizants with ATC code D03AX’ with pharmaceutical form ‘fly larvae’ in the list of medicinal products or product categories subject to prescription that shall not bear the safety features, set out in Annex I to Delegated Regulation (EU) 2016/161. |
| --- | --- |

(8)

It is, therefore, appropriate to include the product category ‘cicatrizants with ATC code D03AX’ with pharmaceutical form ‘fly larvae’ in the list of medicinal products or product categories subject to prescription that shall not bear the safety features, set out in Annex I to Delegated Regulation (EU) 2016/161.

| (9) | Delegated Regulation (EU) 2016/161 should therefore be amended accordingly, |
| --- | --- |

(9)

Delegated Regulation (EU) 2016/161 should therefore be amended accordingly,

HAS ADOPTED THIS REGULATION:

Article 1

Delegated Regulation (EU) 2016/161 is amended as follows:

| (1) | Article 47 is replaced by the following:

  ‘Article 47
  Evaluation of the notifications
  Where, following a notification as referred to in Article 46, the Commission or a Member State considers, on the basis of casualties or hospitalisations of persons in the Union due to exposure to falsified medicinal products, that rapid action is required to protect public health, the Commission shall assess the notification without delay and at the latest within 45 days.’; |
| --- | --- |

(1)

Article 47 is replaced by the following:

‘Article 47

Evaluation of the notifications

Where, following a notification as referred to in Article 46, the Commission or a Member State considers, on the basis of casualties or hospitalisations of persons in the Union due to exposure to falsified medicinal products, that rapid action is required to protect public health, the Commission shall assess the notification without delay and at the latest within 45 days.’;

| (2) | Annex I is amended as set out in the Annex to this Regulation. |
| --- | --- |

(2)

Annex I is amended as set out in 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.

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

Done at Brussels, 7 July 2021.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 311, 28.11.2001, p. 67.

1

(2)  Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (OJ L 32, 9.2.2016, p. 1).

2

(3)  Minutes of the 29th Expert Group on the delegated act on safety features for medicinal products for human use: https://ec.europa.eu/transparency/expert-groups-register/screen/meetings/consult?lang=en&meetingId=20450&fromExpertGroups=true

3

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ANNEX

In Annex I to Delegated Regulation (EU) 2016/161, the following entry is added:

| Name of active substance or product category | Pharmaceutical form | Strength | Remarks |
| --- | --- | --- | --- |
| ‘Cicatrizants with ATC code D03AX | Fly larvae’ | | |

Name of active substance or product category

Pharmaceutical form

Strength

Remarks

‘Cicatrizants with ATC code D03AX

Fly larvae’

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| 21.9.2021 | EN | Official Journal of the European Union | L 332/4 |
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21.9.2021

EN

Official Journal of the European Union

L 332/4

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COMMISSION IMPLEMENTING REGULATION (EU) 2021/1687

of 14 September 2021

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

THE EUROPEAN COMMISSION,

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

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

Whereas:

| (1) | In accordance with Article 17(5) of Regulation (EC) No 110/2008 of the European Parliament and of the Council (2), the Commission has examined Hungary’s application of 6 March 2019 for the registration of the geographical indication ‘Madarasi birspálinka’. |
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(1)

In accordance with Article 17(5) of Regulation (EC) No 110/2008 of the European Parliament and of the Council (2), the Commission has examined Hungary’s application of 6 March 2019 for the registration of the geographical indication ‘Madarasi birspálinka’.

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

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

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

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

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

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

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

(5)

The name ‘Madarasi birspálinka’ should therefore be registered as a geographical indication,

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

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

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

Done at Brussels, 14 September 2021.

For the Commission,

On behalf of the President,

Janusz WOJCIECHOWSKI

Member of the Commission

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

1

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

2

(3)  
  OJ C 205, 31.5.2021, p. 13.

3

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| 21.9.2021 | EN | Official Journal of the European Union | L 332/6 |
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21.9.2021

EN

Official Journal of the European Union

L 332/6

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COMMISSION IMPLEMENTING REGULATION (EU) 2021/1688

of 20 September 2021

amending Implementing Regulation (EU) 2020/1201 as regards the lists of host plants and specified plants, and the tests for the identification of Xylella fastidiosa

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2016/2031 of the European Parliament and of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (1), and in particular Article 28(1) and (2) thereof,

Whereas:

| (1) | Commission Implementing Regulation (EU) 2020/1201 (2) has been applied since August 2020 with the aim to prevent further spread within and introduction into the Union of Xylella fastidiosa (Wells et al.) (‘the specified pest’). |
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(1)

Commission Implementing Regulation (EU) 2020/1201 (2) has been applied since August 2020 with the aim to prevent further spread within and introduction into the Union of Xylella fastidiosa (Wells et al.) (‘the specified pest’).

| (2) | Implementing Regulation (EU) 2020/1201 contains a provision on official checks at introduction into the Union. That provision refers to the official checks to be performed at the point of entry into the Union or at the place of destination established in accordance with Commission Directive 2004/103/EC (3). Within the new framework for official checks established by Regulation (EU) 2017/625 of the European Parliament and of the Council (4), Commission Delegated Regulation (EU) 2019/2123 (5) established new rules on official checks performed at control points other than border control posts. Delegated Regulation (EU) 2019/2123 repealed Directive 2004/103/EC with effect from 14 December 2020. It is therefore appropriate to replace the reference to that Directive by a reference to Delegated Regulation (EU) 2019/2123. |
| --- | --- |

(2)

Implementing Regulation (EU) 2020/1201 contains a provision on official checks at introduction into the Union. That provision refers to the official checks to be performed at the point of entry into the Union or at the place of destination established in accordance with Commission Directive 2004/103/EC (3). Within the new framework for official checks established by Regulation (EU) 2017/625 of the European Parliament and of the Council (4), Commission Delegated Regulation (EU) 2019/2123 (5) established new rules on official checks performed at control points other than border control posts. Delegated Regulation (EU) 2019/2123 repealed Directive 2004/103/EC with effect from 14 December 2020. It is therefore appropriate to replace the reference to that Directive by a reference to Delegated Regulation (EU) 2019/2123.

| (3) | On 23 June 2021, the European Food Safety Authority updated the database of host plants susceptible to Xylella fastidiosa (Wells et al.). Annexes I and II to Implementing Regulation (EU) 2020/1201 should therefore be amended accordingly. |
| --- | --- |

(3)

On 23 June 2021, the European Food Safety Authority updated the database of host plants susceptible to Xylella fastidiosa (Wells et al.). Annexes I and II to Implementing Regulation (EU) 2020/1201 should therefore be amended accordingly.

| (4) | For reasons of transparency and clarity, it is appropriate to indicate, for each of the tests listed in Annex IV to Implementing Regulation (EU) 2020/1201, the Digital Object Identifier (DOI) which allows direct access to the scientific articles describing those tests. |
| --- | --- |

(4)

For reasons of transparency and clarity, it is appropriate to indicate, for each of the tests listed in Annex IV to Implementing Regulation (EU) 2020/1201, the Digital Object Identifier (DOI) which allows direct access to the scientific articles describing those tests.

| (5) | Implementing Regulation (EU) 2020/1201 should therefore be amended accordingly. |
| --- | --- |

(5)

Implementing Regulation (EU) 2020/1201 should therefore be amended accordingly.

| (6) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food, and Feed, |
| --- | --- |

(6)

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

HAS ADOPTED THIS REGULATION:

Article 1

Implementing Regulation (EU) 2020/1201 is amended as follows:

| (1) | in Article 33, paragraph 1 is replaced by the following:

  ‘1.   All consignments of host plants, introduced into the Union from a third country, shall be officially checked at the border control post of first arrival into the Union or at a control point in the cases and conditions set out in Commission Delegated Regulation (EU) 2019/2123’; |
| --- | --- |

(1)

in Article 33, paragraph 1 is replaced by the following:

‘1.   All consignments of host plants, introduced into the Union from a third country, shall be officially checked at the border control post of first arrival into the Union or at a control point in the cases and conditions set out in Commission Delegated Regulation (EU) 2019/2123’;

| (2) | Annex I is replaced by the text set out in Annex I to this Regulation; |
| --- | --- |

(2)

Annex I is replaced by the text set out in Annex I to this Regulation;

| (3) | Annex II is replaced by the text set out in Annex II to this Regulation; |
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(3)

Annex II is replaced by the text set out in Annex II to this Regulation;

| (4) | Annex IV is replaced by the text set out in Annex III to this Regulation. |
| --- | --- |

(4)

Annex IV is replaced by the text set out in Annex III 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.

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

Done at Brussels, 20 September 2021.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 317, 23.11.2016, p. 4.

1

(2)  Commission Implementing Regulation (EU) 2020/1201 of 14 August 2020 as regards measures to prevent the introduction into and the spread within the Union of Xylella fastidiosa (Wells et al.) (OJ L 269, 17.8.2020, p. 2).

2

et al

(3)  Commission Directive 2004/103/EC of 7 October 2004 on identity and plant health checks of plants, plant products or other objects, listed in Part B of Annex V to Council Directive 2000/29/EC, which may be carried out at a place other than the point of entry into the Community or at a place close by and specifying the conditions related to these checks (OJ L 313, 12.10.2004, p. 16).

3

(4)  Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).

4

(5)  Commission Delegated Regulation (EU) 2019/2123 of 10 October 2019 supplementing Regulation (EU) 2017/625 of the European Parliament and of the Council as regards rules for the cases where and the conditions under which identity checks and physical checks on certain goods may be performed at control points and documentary checks may be performed at distance from border control posts (OJ L 321, 12.12.2019, p. 64).

5

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ANNEX I

Annex I to Implementing Regulation (EU) 2020/1201 is replaced by the following:

‘ANNEX I

List of plants known to be susceptible to one or more subspecies of the specified pest (‘host plants’)

Acacia

Acer

Adenocarpus lainzii

Albizia julibrissin Durazz.

Alnus rhombifolia Nutt.

Amaranthus retroflexus L.

Ambrosia

Ampelopsis arborea (L.) Koehne

Ampelopsis brevipedunculata (Maxim.) Trautv.

Ampelopsis cordata Michx.

Anthyllis hermanniae L.

Artemisia

Asparagus acutifolius L.

Athyrium filix-femina

Baccharis

Brassica

Calicotome spinosa (L.) Link

Calicotome villosa (Poiret) Link

Callicarpa americana L.

Callistemon citrinus (Curtis) Skeels

Calluna vulgaris (L.) Hull

Carya

Catharanthus roseus

Celtis occidentalis L.

Cercis canadensis L.

Cercis occidentalis Torr.

Cercis siliquastrum L.

Chamaecrista fasciculata (Michx.) Greene

Chenopodium album L.

Chionanthus

Chitalpa tashkentensis T. S. Elias & Wisura

Cistus

Citrus

Clematis cirrhosa L.

Coelorachis cylindrica (Michx.) Nash Coffea

Conium maculatum L.

Convolvulus cneorum L.

Coprosma repens A.Rich.

Coronilla

Cyperus eragrostis Lam.

Cytisus

Digitaria

Diospyros kaki L.f.

Diplocyclos palmatus (L.) C.Jeffrey

Dodonaea viscosa (L.) Jacq.

Echium plantagineum

Elaeagnus angustifolia L.

Encelia farinosa A. Gray ex Torr.

Eremophila maculata (Ker Gawler) F. von Müller.

Erigeron

Erodium moschatum (L.) L'Hérit.

Erysimum hybrids

Euphorbia chamaesyce L.

Euphorbia terracina L.

Euryops chrysanthemoides (DC.) B.Nord

Euryops pectinatus (L.) Cass.

Fagus crenata Blume

Fallopia japonica (Houtt.) Ronse Decr.

Fatsia japonica (Thunb.) Decne. & Planch.

Ficus carica L.

Fortunella

Frangula alnus Mill.

Fraxinus

Genista

Ginkgo biloba L.

Gleditsia triacanthos L.

Grevillea juniperina Br.

Hebe

Helianthus

Helichrysum

Heliotropium europaeum L.

Hemerocallis

Hevea brasiliensis (Willd. ex A.Juss.) Müll.Arg.

Hibiscus

Humulus scandens (Lour.) Merr.

Ilex aquifolium L.

Ilex vomitoria Sol. ex Aiton

Iva annua L.

Jacaranda mimosifolia D. Don

Juglans

Juniperus ashei J. Buchholz

Koelreuteria bipinnata Franch.

Lagerstroemia

Laurus nobilis L.

Lavandula

Lavatera cretica

Ligustrum lucidum L.

Liquidambar styraciflua L.

Lonicera implexa

Lonicera japonica Thunb.

Lupinus aridorum

Lupinus villlosus

Magnolia grandiflora L.

Mallotus paniculatus (Lam.) Müll.Arg.

Medicago arborea L.

Medicago sativa L.

Metrosideros

Mimosa

Modiola caroliniana (L.) G. Don

Morus

Myoporum insulare R. Br.

Myrtus communis L.

Nandina domestica Murray

Neptunia lutea (Leavenw.) Benth.

Nerium oleander L.

Olea

Osteospermum ecklonis DC.

Osteospermum fruticosum (L.) Norl.

Parthenocissus quinquefolia (L.) Planch.

Paspalum dilatatum Poir.

Pelargonium

Perovskia abrotanoides

Persea americana Mill.

Phagnalon saxatile (L.) Cass.

Phillyrea angustifolia L.

Phillyrea latifolia L.

Phlomis fruticosa L.

Phoenix

Pinus taeda L.

Pistacia vera L.

Plantago lanceolata L.

Platanus

Pluchea odorata (L.) Cass.

Polygala grandiflora

Polygala myrtifolia L.

Prunus

Psidium

Pteridium aquilinum

Pyrus

Quercus

Ratibida columnifera (Nutt.) Wooton & Standl.

Rhamnus

Rhus

Robinia pseudoacacia L.

Rosa

Rosmarinus

Rubus

Ruta chalapensis

Salvia mellifera Greene

Salvia officinalis

Salvia rosmarinus

Sambucus

Santolina chamaecyparissus L.

Santolina magonica

Sapindus saponaria L.

Sassafras

Setaria magna Griseb.

Solidago fistulosa Mill.

Solidago virgaurea L.

Sorghum halepense (L.) Pers.

Spartium

Stewartia pseudocamellia

Strelitzia reginae Aiton

Streptocarpus

Symphyotrichum divaricatum (Nutt.) G.L.Nesom

Teucrium capitatum L.

Trifolium repens L.

Ulex

Ulmus

Vaccinium

Vinca

Vitis

Westringia fruticosa (Willd.) Druce

Westringia glabra R.Br.

Xanthium strumarium L.

---

ANNEX II

Annex II to Implementing Regulation (EU) 2020/1201 is replaced by the following:

‘ANNEX II

List of plants known to be susceptible to specific subspecies of the specified pest (‘specified plants’)

Specified plants susceptible to Xylella fastidiosa subspecies fastidiosa

Acer

Ambrosia artemisiifolia L.

Calicotome spinosa (L.) Link

Cercis occidentalis Torr.

Cistus monspeliensis L.

Citrus sinensis (L.) Osbeck

Coffea

Erysimum

Genista lucida L.

Juglans regia L.

Lupinus aridorum

Magnolia grandiflora L.

Medicago sativa L.

Metrosideros

Morus

Nerium oleander L.

Pluchea odorata (L.) Cass.

Polygala myrtifolia L.

Psidium

Prunus

Rhamnus alaternus L.

Salvia rosmarinum

Rubus rigidus Sm.

Rubus ursinus Cham. & Schldl.

Ruta chalapensis

Sambucus

Spartium junceum L.

Streptocarpus

Teucrium capitatum L.

Ulmus americana L.

Vaccinium corymbosum

Vinca

Vitis

Specified plants susceptible to Xylella fastidiosa subspecies multiplex

Acacia

Acer griseum (Franch.) Pax

Acer pseudoplatanus L.

Acer rubrum L.

Adenocarpus lainzii

Alnus rhombifolia Nutt.

Ambrosia

Ampelopsis cordata Michx.

Anthyllis hermanniae L.

Artemisia

Athyrium filix-femina

Asparagus acutifolius L.

Baccharis halimifolia L.

Calicotome spinosa (L.) Link

Calicotome villosa (Poir.) Link

Callistemon citrinus (Curtis) Skeels

Calluna vulgaris (L.) Hull

Carya

Celtis occidentalis L.

Cercis canadensis L.

Cercis occidentalis Torr.

Cercis siliquastrum L.

Chionanthus

Cistus

Clematis cirrhosa L.

Convolvulus cneorum L.

Coprosma repens A. Rich.

Coronilla

Cytisus

Dodonaea viscosa (L.) Jacq.

Echium plantagineum

Elaeagnus angustifolia L.

Encelia farinosa Gray ex Torr.

Erigeron

Erodium moschatum

Euryops chrysanthemoides (DC.) B.Nord.

Euryops pectinatus (L.) Cass.

Fallopia japonica (Houtt.) Ronse Decr.

Ficus carica L.

Frangula alnus Mill.

Fraxinus

Genista

Ginkgo biloba L.

Gleditsia triacanthos L.

Grevillea juniperina Br.

Hebe

Helianthus

Helichrysum

Hibiscus syriacus

Ilex aquifolium L.

Iva annua L.

Koelreuteria bipinnata Franch.

Lagerstroemia

Laurus nobilis L.

Lavandula

Lavatera cretica

Liquidambar styraciflua L.

Lonicera

Lupinus aridorum

Lupinus villosus Willd.

Magnolia grandiflora L.

Medicago arborea L.

Medicago sativa L.

Metrosideros

Myrtus communis L.

Nerium oleander

Olea

Osteospermum ecklonis (DC.) Norl.

Pelargonium

Perovskia abrotanoides

Phagnalon saxatile (L.) Cass.

Phillyrea angustifolia L.

Phillyrea latifolia

Phlomis fruticosa L.

Pistacia vera L.

Plantago lanceolata L.

Platanus

Polygala myrtifolia L.

Polygala grandiflora

Prunus

Pteridium aquilinum

Quercus

Ratibida columnifera (Nutt.) Wooton & Standl.

Rhamnus

Robinia pseudoacacia L.

Rosa

Rosmarinus

Rubus

Salvia mellifera Greene

Salvia officinalis

Salvia rosmarinus

Sambucus

Santolina chamaecyparissus L.

Santolina magonica

Sapindus saponaria L.

Solidago virgaurea L.

Spartium

Strelitzia reginae Aiton

Ulex

Ulmus

Vaccinium

Vinca

Westringia fruticosa Guerin.

Xanthium strumarium L.

Specified plants susceptible to Xylella fastidiosa subspecies pauca

Acacia

Amaranthus retroflexus L.

Asparagus acutifolius L.

Catharanthus roseus (L.) G. Don

Chenopodium album L.

Cistus albidus L.

Cistus creticus L.

Citrus

Coffea

Dodonaea viscosa (L.) Jacq.

Eremophila maculata (Ker Gawler) F. von Müller.

Erigeron

Euphorbia chamaesyce L.

Euphorbia terracina L.

Grevillea juniperina Br.

Hebe

Heliotropium europaeum L.

Hibiscus

Laurus nobilis L.

Lavandula

Myoporum insulare Br.

Myrtus communis L.

Nerium oleander L.

Olea europaea L.

Osteospermum fruticosum (L.) Norl.

Pelargonium

Phillyrea latifolia L.

Pistacia vera

Polygala myrtifolia L.

Prunus

Rhamnus alaternus L.

Spartium junceum L.

Ulmus parviflorus

Vinca minor L.

Westringia fruticosa (Willd.) Druce

Westringia glabra Br.

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ANNEX III

Annex IV to Implementing Regulation (EU) 2020/1201 is replaced by the following:

‘ANNEX IV

Tests for the identification of Xylella fastidiosa and its subspecies

A.   Tests for the screening and identification of the presence of Xylella fastidiosa

| 1. | Real time PCR based on Harper et al., 2010 (and erratum 2013) (1); |
| --- | --- |

1.

Real time PCR based on Harper et al., 2010 (and erratum 2013) (1);

| 2. | Loop-mediated isothermal amplification (LAMP) based on primers developed by Harper et al. 2010 (and erratum 2013) (2); |
| --- | --- |

2.

Loop-mediated isothermal amplification (LAMP) based on primers developed by Harper et al. 2010 (and erratum 2013) (2);

| 3. | Real time PCR based on Ouyang et al., 2013 (3) |
| --- | --- |

3.

Real time PCR based on Ouyang et al., 2013 (3)

| 4. | Conventional PCR based on Minsavage et al. 1994 (4) |
| --- | --- |

4.

Conventional PCR based on Minsavage et al. 1994 (4)

B.   Molecular tests for the identification of the subspecies of Xylella fastidiosa

| 1. | Multi Locus Sequence Typing (MLST) based on Yuan et al., 2010 determining all subspecies (5); |
| --- | --- |

1.

Multi Locus Sequence Typing (MLST) based on Yuan et al., 2010 determining all subspecies (5);

| 2. | PCR based on Hernandez-Martinez et al., 2006 determining the subspecies fastidiosa, multiplex and sandyi
   (6); |
| --- | --- |

2.

PCR based on Hernandez-Martinez et al., 2006 determining the subspecies fastidiosa, multiplex and sandyi
   (6);

| 3. | PCR based on Pooler & Hartung 1995 determining the subspecies pauca
   (7). |
| --- | --- |

3.

PCR based on Pooler & Hartung 1995 determining the subspecies pauca
   (7).

---

(1)  DOI: 10.1094/PHYTO-06-10-0168.

1

(2)  DOI: 10.1094/PHYTO-06-10-0168.

2

(3)  DOI: 10.1371/journal.pone.0081647.

3

(4)  DOI:10.1094/Phyto-84-456.

4

(5)  DOI: 10.1094/PHYTO-100-6-0601.

5

(6)  DOI: 10.1094/PD-90-1382.

6

(7)  DOI: 10.1007/BF00294703.’

7

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