# Official Journal L 84/2020

| | ISSN 1977-0677 |
| --- | --- |
| Official Journal
  of the European Union | L 84 |
| | |
| English edition | Legislation | Volume 6320 March 2020 |

ISSN 1977-0677

Official Journal

of the European Union

L 84

English edition

Legislation

Volume 6320 March 2020

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| Contents | | II   Non-legislative acts | page |
| --- | --- | --- | --- |
| | | REGULATIONS |
| | * | Commission Delegated Regulation (EU) 2020/419 of 30 January 2020 derogating from Delegated Regulation (EU) 2016/1149 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards the national support programmes in the wine sector | 1 |
| | * | Commission Implementing Regulation (EU) 2020/420 of 16 March 2020 correcting the German language version of Regulation (EU) 2016/919 on the technical specification for interoperability relating to the control-command and signalling subsystems of the rail system in the European Union (
  1
  ) | 5 |
| | * | Commission Implementing Regulation (EU) 2020/421 of 18 March 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, Lecanicillium muscarium (formerly Verticillium lecanii) strain Ve6, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, Phlebiopsis gigantea strains FOC PG 410.3, VRA 1835 and VRA 1984, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad, Streptomyces K61 (formerly S. griseoviridis), Trichoderma asperellum (formerly T. harzianum) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly T. harzianum) strains IMI 206040 and T11, Trichoderma gamsii (formerly T. viride) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram (
  1
  ) | 7 |
| | * | Commission Regulation (EU) 2020/422 of 19 March 2020 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2020 (
  1
  ) | 11 |
| | * | Commission Implementing Regulation (EU) 2020/423 of 19 March 2020 amending Regulation (EC) No 1010/2009 as regards administrative arrangements with third countries on catch certificates for marine fisheries products | 15 |
| | * | Commission Implementing Regulation (EU) 2020/424 of 19 March 2020 on submitting information to the Commission as regards non-application of technical specifications for interoperability in accordance with Directive (EU) 2016/797 | 20 |

Contents

II   Non-legislative acts

page

REGULATIONS

*

Commission Delegated Regulation (EU) 2020/419 of 30 January 2020 derogating from Delegated Regulation (EU) 2016/1149 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards the national support programmes in the wine sector

1

*

Commission Implementing Regulation (EU) 2020/420 of 16 March 2020 correcting the German language version of Regulation (EU) 2016/919 on the technical specification for interoperability relating to the control-command and signalling subsystems of the rail system in the European Union (
  1
  )

1

5

*

Commission Implementing Regulation (EU) 2020/421 of 18 March 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, Lecanicillium muscarium (formerly Verticillium lecanii) strain Ve6, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, Phlebiopsis gigantea strains FOC PG 410.3, VRA 1835 and VRA 1984, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad, Streptomyces K61 (formerly S. griseoviridis), Trichoderma asperellum (formerly T. harzianum) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly T. harzianum) strains IMI 206040 and T11, Trichoderma gamsii (formerly T. viride) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram (
  1
  )

Bacillus subtilis

Bacillus thuringiensis

Bacillus thuringiensis

Bacillus thuringiensis

Beauveria bassiana

Cydia pomonella Granulovirus

Lecanicillium muscarium

Verticillium lecanii

Metarhizium anisopliae

Phlebiopsis gigantea

Pseudomonas chlororaphis

Pythium oligandrum

Streptomyces

S. griseoviridis

Trichoderma asperellum

T. harzianum

Trichoderma atroviride

T. harzianum

Trichoderma gamsii

T. viride

Trichoderma harzianum

1

7

*

Commission Regulation (EU) 2020/422 of 19 March 2020 amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2020 (
  1
  )

1

11

*

Commission Implementing Regulation (EU) 2020/423 of 19 March 2020 amending Regulation (EC) No 1010/2009 as regards administrative arrangements with third countries on catch certificates for marine fisheries products

15

*

Commission Implementing Regulation (EU) 2020/424 of 19 March 2020 on submitting information to the Commission as regards non-application of technical specifications for interoperability in accordance with Directive (EU) 2016/797

20

| | | Corrigenda |
| --- | --- | --- |
| | * | Corrigendum to Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat ( OJ L 079I, 16.3.2020 ) | 24 |

Corrigenda

*

Corrigendum to Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat ( OJ L 079I, 16.3.2020 )

( OJ L 079I, 16.3.2020 )

24

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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

| 20.3.2020 | EN | Official Journal of the European Union | L 84/1 |
| --- | --- | --- | --- |

20.3.2020

EN

Official Journal of the European Union

L 84/1

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COMMISSION DELEGATED REGULATION (EU) 2020/419

of 30 January 2020

derogating from Delegated Regulation (EU) 2016/1149 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards the national support programmes in the wine sector

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (1), and in particular Article 53(b) and (h) thereof,

Whereas:

| (1) | On 2 October 2019, the World Trade Organization (WTO) issued the arbitration decision in European Communities and Certain Member States – Measures Affecting Trade in Large Civil Aircraft, WT/DS316/ARB. The arbitration decision entitled the United States of America (USA) to request an authorisation to impose countermeasures at a level not exceeding USD 7,5 billion annually in response to Union subsidies to Airbus. On 18 October 2019, the USA imposed a 25 % ad valorem import duty on, among others, still wines exported to the USA by Germany, Spain, France and the United Kingdom. This exceptional, inequitable and unpredictable situation is having a severe and detrimental impact on the global trade of all Union wines. The USA have further threatened to apply 100 % ad valorem import duties on French sparkling wines in response to the French Digital Services Tax (GAFA tax). |
| --- | --- |

(1)

On 2 October 2019, the World Trade Organization (WTO) issued the arbitration decision in European Communities and Certain Member States – Measures Affecting Trade in Large Civil Aircraft, WT/DS316/ARB. The arbitration decision entitled the United States of America (USA) to request an authorisation to impose countermeasures at a level not exceeding USD 7,5 billion annually in response to Union subsidies to Airbus. On 18 October 2019, the USA imposed a 25 % ad valorem import duty on, among others, still wines exported to the USA by Germany, Spain, France and the United Kingdom. This exceptional, inequitable and unpredictable situation is having a severe and detrimental impact on the global trade of all Union wines. The USA have further threatened to apply 100 % ad valorem import duties on French sparkling wines in response to the French Digital Services Tax (GAFA tax).

| (2) | The import duties imposed by the USA are having a direct and severe impact on the Union wine trade on the USA market, which is the Union’s largest export market for agricultural products, and for wine in particular, both in terms of value and volume of exports. In 2018, Union wine exports to the USA totalled 6,5 million hectolitres, accounting for EUR 4 billion. Union wine exports to the USA typically represent between 30 % and 40 % of the global Union wine export value. |
| --- | --- |

(2)

The import duties imposed by the USA are having a direct and severe impact on the Union wine trade on the USA market, which is the Union’s largest export market for agricultural products, and for wine in particular, both in terms of value and volume of exports. In 2018, Union wine exports to the USA totalled 6,5 million hectolitres, accounting for EUR 4 billion. Union wine exports to the USA typically represent between 30 % and 40 % of the global Union wine export value.

| (3) | The increased import duties imposed by the USA are having a damaging effect on all Union wine, not only on still wines originating from the four Member States that are subject to the increased import duties. The reputation and trade of all Union wine present in the USA market is adversely impacted as a result. The reputation of a wine is determined not only by its quality but also by its price and the perceived price-quality ratio. This is particularly the case for the lower to middle range priced wines, which, in absolute terms, are more impacted by a 25 % import duty than more expensive wines that are purchased by connoisseurs for whom a price increase does not operate as a deterrent. Union wines compete in the USA market with wines from other origins such as South America, Australia or South Africa. In the light of such fierce and intense competition, perception of overall price levels plays a significant role. Where the consumer is aware that the price of wine from certain origins within the Union is subject to an increased import duty, this will have a negative impact on the overall perception of the price level of Union wines as such and thus divert consumer demand to products of other origins. In the light of the identified resulting market conditions and decrease in overall returns to producers, immediate measures to address the effects of the import duties are warranted covering all wines originating in all Member States and not only in those directly targeted by the import duties. |
| --- | --- |

(3)

The increased import duties imposed by the USA are having a damaging effect on all Union wine, not only on still wines originating from the four Member States that are subject to the increased import duties. The reputation and trade of all Union wine present in the USA market is adversely impacted as a result. The reputation of a wine is determined not only by its quality but also by its price and the perceived price-quality ratio. This is particularly the case for the lower to middle range priced wines, which, in absolute terms, are more impacted by a 25 % import duty than more expensive wines that are purchased by connoisseurs for whom a price increase does not operate as a deterrent. Union wines compete in the USA market with wines from other origins such as South America, Australia or South Africa. In the light of such fierce and intense competition, perception of overall price levels plays a significant role. Where the consumer is aware that the price of wine from certain origins within the Union is subject to an increased import duty, this will have a negative impact on the overall perception of the price level of Union wines as such and thus divert consumer demand to products of other origins. In the light of the identified resulting market conditions and decrease in overall returns to producers, immediate measures to address the effects of the import duties are warranted covering all wines originating in all Member States and not only in those directly targeted by the import duties.

| (4) | From a market stability perspective, the import duty regime imposed by the USA does not represent an isolated national measure with effects limited to the trade with the USA. The world wine market is a global market on which single measures taken by important economic players such as the USA have far-reaching repercussions affecting the international trade in wine as a whole. Any negative change in the conditions in a major destination market for Union wines, such as the USA, inevitably affects other markets since the products that cannot be sold in the USA, having become too expensive, need to be diverted elsewhere. Consequently, consumers in those other markets, being well aware of the market conditions, will exert additional pressure on prices and competition will also be much fiercer than normal. The current import duties imposed by the USA are therefore likely to cause stagnation in Union wine exports worldwide. Reports from the wine sector have shown that significant orders of French wines on the USA market have already been cancelled. |
| --- | --- |

(4)

From a market stability perspective, the import duty regime imposed by the USA does not represent an isolated national measure with effects limited to the trade with the USA. The world wine market is a global market on which single measures taken by important economic players such as the USA have far-reaching repercussions affecting the international trade in wine as a whole. Any negative change in the conditions in a major destination market for Union wines, such as the USA, inevitably affects other markets since the products that cannot be sold in the USA, having become too expensive, need to be diverted elsewhere. Consequently, consumers in those other markets, being well aware of the market conditions, will exert additional pressure on prices and competition will also be much fiercer than normal. The current import duties imposed by the USA are therefore likely to cause stagnation in Union wine exports worldwide. Reports from the wine sector have shown that significant orders of French wines on the USA market have already been cancelled.

| (5) | The Union wine market has been subject to aggravating conditions throughout 2019 and wine stocks are at their highest level since 2009. This development is due primarily to a combination of the record harvest in 2018 and decreasing wine consumption in the Union. If the wines affected by the import duties imposed by the USA are not sold in the export markets outside the Union, this will only serve to amplify the urgency and seriousness of the situation in the Union market. Furthermore, the urgency of the situation is aggravated by the timing of the application of the import duty tariffs. The tariffs are applicable from 18 October 2019, which falls right in the middle of the 2019 wine harvest and production campaign and just before the end of year festive season; two of the most important sale periods of the year for the Union wine sector. Against this background, it is therefore necessary to take immediate measures to address the situation. |
| --- | --- |

(5)

The Union wine market has been subject to aggravating conditions throughout 2019 and wine stocks are at their highest level since 2009. This development is due primarily to a combination of the record harvest in 2018 and decreasing wine consumption in the Union. If the wines affected by the import duties imposed by the USA are not sold in the export markets outside the Union, this will only serve to amplify the urgency and seriousness of the situation in the Union market. Furthermore, the urgency of the situation is aggravated by the timing of the application of the import duty tariffs. The tariffs are applicable from 18 October 2019, which falls right in the middle of the 2019 wine harvest and production campaign and just before the end of year festive season; two of the most important sale periods of the year for the Union wine sector. Against this background, it is therefore necessary to take immediate measures to address the situation.

| (6) | Among the support measures in the wine sector set out in Article 43 of Regulation (EU) No 1308/2013, only the promotion measure under Article 45(1)(b) of that Regulation is directly targeted on promoting Union wines in third countries in order to improve their competitiveness. Over the years, the promotion measure has proved remarkably effective to conquer and consolidate markets in third countries. It proved to be the most effective tool to support Union wines on third country markets by enhancing their reputation and raising awareness on their quality. The international wine market is a global market and any promotion operation for Union wine on third country markets is beneficial to all Union wines. It opens opportunities for those who will subsequently enter the market in question with other Union wines. The individual promotions have a ‘multiplier’ effect on sales as they cover whole ranges of wines or entire wine-making regions and not just one individual brand or type of wine. It is therefore essential to continue, launch and intensify promotion activities in all markets in order to find outlets for the wines that will not be sold on the USA market and to preserve the reputation of Union wines in those other markets as well as to counter pressure on prices. |
| --- | --- |

(6)

Among the support measures in the wine sector set out in Article 43 of Regulation (EU) No 1308/2013, only the promotion measure under Article 45(1)(b) of that Regulation is directly targeted on promoting Union wines in third countries in order to improve their competitiveness. Over the years, the promotion measure has proved remarkably effective to conquer and consolidate markets in third countries. It proved to be the most effective tool to support Union wines on third country markets by enhancing their reputation and raising awareness on their quality. The international wine market is a global market and any promotion operation for Union wine on third country markets is beneficial to all Union wines. It opens opportunities for those who will subsequently enter the market in question with other Union wines. The individual promotions have a ‘multiplier’ effect on sales as they cover whole ranges of wines or entire wine-making regions and not just one individual brand or type of wine. It is therefore essential to continue, launch and intensify promotion activities in all markets in order to find outlets for the wines that will not be sold on the USA market and to preserve the reputation of Union wines in those other markets as well as to counter pressure on prices.

| (7) | Therefore, to help operators respond to the current exceptional circumstances in export markets all over the world following the import duty regime imposed by the USA and address this unpredictable and precarious situation, it is appropriate to allow further flexibility in implementing the promotion measure under Article 45(1)(b) of Regulation (EU) No 1308/2013 by derogating from certain provisions set out in Commission Delegated Regulation (EU) 2016/1149 (2). |
| --- | --- |

(7)

Therefore, to help operators respond to the current exceptional circumstances in export markets all over the world following the import duty regime imposed by the USA and address this unpredictable and precarious situation, it is appropriate to allow further flexibility in implementing the promotion measure under Article 45(1)(b) of Regulation (EU) No 1308/2013 by derogating from certain provisions set out in Commission Delegated Regulation (EU) 2016/1149 (2).

| (8) | In order to allow beneficiaries to strengthen their promotion actions and to consolidate their presence on the targeted markets, it should be possible for Member States to extend the duration of the support to already selected operations under the promotion measure referred to in Article 45(1)(b) of Regulation (EU) No 1308/2013 beyond the maximum duration of 5 years set out in Article 4 of Delegated Regulation (EU) 2016/1149. Such a measure will provide more stability and continuity of the promotion operations for the operators already present on the USA market and directly affected by the import duties. Furthermore, it will also benefit those operators promoting wine on other third country markets which are not directly subject to the import duty regime imposed by the USA but who are struggling to keep their position in the newly created unstable wine world market situation of fierce competition. |
| --- | --- |

(8)

In order to allow beneficiaries to strengthen their promotion actions and to consolidate their presence on the targeted markets, it should be possible for Member States to extend the duration of the support to already selected operations under the promotion measure referred to in Article 45(1)(b) of Regulation (EU) No 1308/2013 beyond the maximum duration of 5 years set out in Article 4 of Delegated Regulation (EU) 2016/1149. Such a measure will provide more stability and continuity of the promotion operations for the operators already present on the USA market and directly affected by the import duties. Furthermore, it will also benefit those operators promoting wine on other third country markets which are not directly subject to the import duty regime imposed by the USA but who are struggling to keep their position in the newly created unstable wine world market situation of fierce competition.

| (9) | However, the individual prolongation granted to projects should not extend beyond the current programming period which runs from 2019 to 2023 and thus should end on 15 October 2023. |
| --- | --- |

(9)

However, the individual prolongation granted to projects should not extend beyond the current programming period which runs from 2019 to 2023 and thus should end on 15 October 2023.

| (10) | Further flexibility should be allowed with regard to the possible changes to operations under the promotion measure referred to in Article 45(1)(b) of Regulation (EU) No 1308/2013 as laid down in Article 53(1) of Delegated Regulation (EU) 2016/1149. In order to enable beneficiaries to react adequately and efficiently to exceptional circumstances and adapt their target markets as required, it is appropriate to authorise Member States to derogate from those rules by allowing changes to the destination market even if the change is not in line with the initial objective of the operation. Such a derogation would help beneficiaries currently carrying out promotion operations in the USA to target other markets and prevent further economic losses. It would also provide assistance to those beneficiaries carrying out operations in other third countries affected by the repercussions of the import duty regime imposed by the USA on that particular market and who wish to redirect their efforts elsewhere. |
| --- | --- |

(10)

Further flexibility should be allowed with regard to the possible changes to operations under the promotion measure referred to in Article 45(1)(b) of Regulation (EU) No 1308/2013 as laid down in Article 53(1) of Delegated Regulation (EU) 2016/1149. In order to enable beneficiaries to react adequately and efficiently to exceptional circumstances and adapt their target markets as required, it is appropriate to authorise Member States to derogate from those rules by allowing changes to the destination market even if the change is not in line with the initial objective of the operation. Such a derogation would help beneficiaries currently carrying out promotion operations in the USA to target other markets and prevent further economic losses. It would also provide assistance to those beneficiaries carrying out operations in other third countries affected by the repercussions of the import duty regime imposed by the USA on that particular market and who wish to redirect their efforts elsewhere.

| (11) | To avoid a scenario whereby beneficiaries using the flexibility and deciding to change the targeted market are penalised for not having implemented their overall operation as approved initially by the competent authority, it is also necessary to derogate from Article 54(1) of Delegated Regulation (EU) 2016/1149. This would ensure that support is paid to the individual actions, as amended by this Regulation, as long as those actions are fully implemented and subjected to the applicable checks laid down in Section 1 of Chapter IV of Commission Implementing Regulation (EU) 2016/1150 (3). |
| --- | --- |

(11)

To avoid a scenario whereby beneficiaries using the flexibility and deciding to change the targeted market are penalised for not having implemented their overall operation as approved initially by the competent authority, it is also necessary to derogate from Article 54(1) of Delegated Regulation (EU) 2016/1149. This would ensure that support is paid to the individual actions, as amended by this Regulation, as long as those actions are fully implemented and subjected to the applicable checks laid down in Section 1 of Chapter IV of Commission Implementing Regulation (EU) 2016/1150 (3).

| (12) | The two measures introduced by this Regulation should be applicable to all operators already present on a given third country market to ensure that they are supported in the same way as newcomers to that market who will be entitled to benefit from a higher Union contribution rate of up to 60 % of the eligible expenditure pursuant to Commission Implementing Regulation (EU) 2020/132 (4). These measures should also apply to all operations promoting wine under Article 45(1)(b) of Regulation (EU) No 1308/2013 in disregard of the specific wine category which is promoted given the fact that the import duty regime imposed by the USA affects the reputation of all Union wines as a whole. In addition, it would be very difficult to separate within one promotion operation the actions concerning still wines from the actions concerning other wines since the promotion operations are typically designed to promote a whole range of products and not just a specific category. Many promotion campaigns concern all wines of a region or a broad variety of wines sold by a given operator. To separate the actions concerning other wines from the actions concerning still wines within a promotion campaign would represent a heavy administrative burden and would undermine the positive effects of the promotion operation. |
| --- | --- |

(12)

The two measures introduced by this Regulation should be applicable to all operators already present on a given third country market to ensure that they are supported in the same way as newcomers to that market who will be entitled to benefit from a higher Union contribution rate of up to 60 % of the eligible expenditure pursuant to Commission Implementing Regulation (EU) 2020/132 (4). These measures should also apply to all operations promoting wine under Article 45(1)(b) of Regulation (EU) No 1308/2013 in disregard of the specific wine category which is promoted given the fact that the import duty regime imposed by the USA affects the reputation of all Union wines as a whole. In addition, it would be very difficult to separate within one promotion operation the actions concerning still wines from the actions concerning other wines since the promotion operations are typically designed to promote a whole range of products and not just a specific category. Many promotion campaigns concern all wines of a region or a broad variety of wines sold by a given operator. To separate the actions concerning other wines from the actions concerning still wines within a promotion campaign would represent a heavy administrative burden and would undermine the positive effects of the promotion operation.

| (13) | Therefore, it is necessary to derogate from Article 4, Article 53(1) and Article 54(1) of Delegated Regulation (EU) 2016/1149, |
| --- | --- |

(13)

Therefore, it is necessary to derogate from Article 4, Article 53(1) and Article 54(1) of Delegated Regulation (EU) 2016/1149,

HAS ADOPTED THIS REGULATION:

Article 1

Categories of products covered

This Regulation shall apply to the promotion of wine within the meaning of points (1) to (9) and (15) to (16) of Part II of Annex VII to Regulation (EU) No 1308/2013.

Article 2

Duration of the support

By way of derogation from Article 4 of Delegated Regulation (EU) 2016/1149 and if justified in view of the effects of the operation, the duration of the support for a given beneficiary in a given third country or third-country market for the promotion measure referred to in Article 45(1)(b) of Regulation (EU) No 1308/2013 may be extended beyond the five-year period laid down in Article 4 of Delegated Regulation (EU) 2016/1149, but not later than 15 October 2023.

Article 3

Changes to approved operations

By way of derogation from Article 53(1) of Delegated Regulation (EU) 2016/1149, Member States may allow beneficiaries of an ongoing operation under the promotion measure referred to in Article 45(1)(b) of Regulation (EU) No 1308/2013 to submit, via a notification to the competent authority, changes to the destination market of that operation, even if this change modifies the initial objective of the operation. Such changes shall not require prior approval by the competent authority. The notification shall be submitted by the beneficiaries within the deadlines set by the Member States.

Article 4

Support for implemented individual actions

By way of derogation from Article 54(1) of Delegated Regulation (EU) 2016/1149, where a change of the destination market of an already approved operation has been notified to the competent authority in accordance with Article 3 of this Regulation, support shall be paid for the individual actions already implemented under this operation if these actions have been implemented in full and have been subject to administrative and, where applicable, on-the-spot checks in accordance with Section 1 of Chapter IV of Implementing Regulation (EU) 2016/1150.

Article 5

Entry into force

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

Official Journal of the European Union

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

Done at Brussels, 30 January 2020.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 347, 20.12.2013, p. 671.

1

(2)  Commission Delegated Regulation (EU) 2016/1149 of 15 April 2016 supplementing Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards the national support programmes in the wine sector and amending Commission Regulation (EC) No 555/2008 (OJ L 190, 15.7.2016, p. 1).

2

(3)  Commission Implementing Regulation (EU) 2016/1150 of 15 April 2016 laying down rules for the application of Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards the national support programmes in the wine sector (OJ L 190, 15.7.2016, p. 23).

3

(4)  Commission Implementing Regulation (EU) 2020/132 of 30 January 2020 laying down an emergency measure in the form of a derogation from Article 45(3) of Regulation (EU) No 1308/2013 of the European Parliament and of the Council as regards Union contribution to the promotion measure in the wine sector (OJ L 27, 31.1.2020, p. 20).

4

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| 20.3.2020 | EN | Official Journal of the European Union | L 84/5 |
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20.3.2020

EN

Official Journal of the European Union

L 84/5

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COMMISSION IMPLEMENTING REGULATION (EU) 2020/420

of 16 March 2020

correcting the German language version of Regulation (EU) 2016/919 on the technical specification for interoperability relating to the ‘control-command and signalling’ subsystems of the rail system in the European Union

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (1), and in particular Article 5(11) thereof,

Whereas:

| (1) | The German language version of Commission Regulation (EU) 2016/919 (2) contains an error in paragraph 2 of section 7.4.2.3 of the Annex as regards the conditions for the application of a transition phase. |
| --- | --- |

(1)

The German language version of Commission Regulation (EU) 2016/919 (2) contains an error in paragraph 2 of section 7.4.2.3 of the Annex as regards the conditions for the application of a transition phase.

| (2) | The German language version of Regulation (EU) 2016/919 should therefore be corrected accordingly. The other language versions are not affected. |
| --- | --- |

(2)

The German language version of Regulation (EU) 2016/919 should therefore be corrected accordingly. The other language versions are not affected.

| (3) | Due to the error in paragraph 2 of section 7.4.2.3 of the Annex, economic operators undergo unnecessary restrictive requirements on the placing on the market of railway vehicles. From 16 June 2019 to 31 December 2020, it should be possible, under specific conditions, to issue authorisations for the placing on the market of vehicles in conformity to set of specifications #1 referred to in Table A 2 of Annex A to the Annex to Regulation (EU) 2016/919. The conditions to be met should be that the vehicles are authorised in conformity to a vehicle type that was authorised before 1 January 2019 in conformity to set of specifications #1 referred to in Table A 2 of Annex A to the Annex to Regulation (EU) 2016/919. Therefore, the German language version should be corrected with retroactivity. |
| --- | --- |

(3)

Due to the error in paragraph 2 of section 7.4.2.3 of the Annex, economic operators undergo unnecessary restrictive requirements on the placing on the market of railway vehicles. From 16 June 2019 to 31 December 2020, it should be possible, under specific conditions, to issue authorisations for the placing on the market of vehicles in conformity to set of specifications #1 referred to in Table A 2 of Annex A to the Annex to Regulation (EU) 2016/919. The conditions to be met should be that the vehicles are authorised in conformity to a vehicle type that was authorised before 1 January 2019 in conformity to set of specifications #1 referred to in Table A 2 of Annex A to the Annex to Regulation (EU) 2016/919. Therefore, the German language version should be corrected with retroactivity.

| (4) | The measures provided for in this Regulation are in accordance with the opinion of the Committee established in accordance with Article 51(1) of Directive (EU) 2016/797, |
| --- | --- |

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Committee established in accordance with Article 51(1) of Directive (EU) 2016/797,

HAS ADOPTED THIS REGULATION:

Article 1

(does not concern the English language)

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 with effect from 16 June 2019.

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

Done at Brussels, 16 March 2020.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 138, 26.5.2016, p. 44.

1

(2)  Commission Regulation (EU) 2016/919 of 27 May 2016 on the technical specification for interoperability relating to the ‘control-command and signalling’ subsystems of the rail system in the European Union (OJ L 158, 15.6.2016, p. 1).

2

---

| 20.3.2020 | EN | Official Journal of the European Union | L 84/7 |
| --- | --- | --- | --- |

20.3.2020

EN

Official Journal of the European Union

L 84/7

---

COMMISSION IMPLEMENTING REGULATION (EU) 2020/421

of 18 March 2020

amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS-1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, Lecanicillium muscarium (formerly ‘
  Verticillium lecanii
  ’) strain Ve6, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, Phlebiopsis gigantea strains FOC PG 410.3, VRA 1835 and VRA 1984, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad, Streptomyces K61 (formerly ‘
  S. griseoviridis
  ’), Trichoderma asperellum (formerly ‘
  T. harzianum
  ’) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly ‘
  T. harzianum
  ’) strains IMI 206040 and T11, Trichoderma gamsii (formerly ‘
  T. viride
  ’) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (1), and in particular the first paragraph of Article 17 thereof,

Whereas:

| (1) | Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009. |
| --- | --- |

(1)

Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011 (2) sets out the active substances deemed to have been approved under Regulation (EC) No 1107/2009.

| (2) | The approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS 1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, Lecanicillium muscarium (formerly ‘Verticillium lecani
  i’) strain Ve6, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, Phlebiopsis gigantea strains FOC PG 410.3, VRA 1835 and VRA 1984, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad, Streptomyces K61 (formerly ‘S. griseoviridi
  s’), Trichoderma asperellum (formerly ‘T. harzianu
  m’) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly ‘T. harzianu
  m’) strains IMI 206040 and T11, Trichoderma gamsii (formerly ‘T. virid
  e’) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram were extended until 30 April 2020 by Commission Implementing Regulation (EU) 2019/168 (3). |
| --- | --- |

(2)

The approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) strain QST 713, Bacillus thuringiensis subsp. Aizawai strains ABTS 1857 and GC-91, Bacillus thuringiensis subsp. Israeliensis (serotype H-14) strain AM65-52, Bacillus thuringiensis subsp. Kurstaki strains ABTS 351, PB 54, SA 11, SA12 and EG 2348, Beauveria bassiana strains ATCC 74040 and GHA, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, fenpyroximate, fosetyl, Lecanicillium muscarium (formerly ‘Verticillium lecani
  i’) strain Ve6, mepanipyrim, Metarhizium anisopliae (var. anisopliae) strain BIPESCO 5/F52, metconazole, metrafenone, Phlebiopsis gigantea strains FOC PG 410.3, VRA 1835 and VRA 1984, pirimicarb, Pseudomonas chlororaphis strain MA342, pyrimethanil, Pythium oligandrum M1, rimsulfuron, spinosad, Streptomyces K61 (formerly ‘S. griseoviridi
  s’), Trichoderma asperellum (formerly ‘T. harzianu
  m’) strains ICC012, T25 and TV1, Trichoderma atroviride (formerly ‘T. harzianu
  m’) strains IMI 206040 and T11, Trichoderma gamsii (formerly ‘T. virid
  e’) strain ICC080, Trichoderma harzianum strains T-22 and ITEM 908, triclopyr, trinexapac, triticonazole and ziram were extended until 30 April 2020 by Commission Implementing Regulation (EU) 2019/168 (3).

| (3) | Applications for the renewal of the approval of those substances were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (4). |
| --- | --- |

(3)

Applications for the renewal of the approval of those substances were submitted in accordance with Commission Implementing Regulation (EU) No 844/2012 (4).

| (4) | Furthermore, an extension of the approval period is prescribed for the active substances dichlorprop-P, mepanipyrim, spinosad, trinexapac and fosetyl, to allow the necessary time to carry out the assessment relating to endocrine disrupting properties in accordance with the procedure set out in Articles 13 and 14 of Implementing Regulation (EU) No 844/2012. |
| --- | --- |

(4)

Furthermore, an extension of the approval period is prescribed for the active substances dichlorprop-P, mepanipyrim, spinosad, trinexapac and fosetyl, to allow the necessary time to carry out the assessment relating to endocrine disrupting properties in accordance with the procedure set out in Articles 13 and 14 of Implementing Regulation (EU) No 844/2012.

| (5) | Due to the fact that the assessment of all those substances has been delayed for reasons beyond the control of the applicants, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods. |
| --- | --- |

(5)

Due to the fact that the assessment of all those substances has been delayed for reasons beyond the control of the applicants, the approvals of those active substances are likely to expire before a decision has been taken on their renewal. It is therefore necessary to extend their approval periods.

| (6) | In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission is to adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission is to set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission is to adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date. |
| --- | --- |

(6)

In view of the aim of the first paragraph of Article 17 of Regulation (EC) No 1107/2009, as regards cases where the Commission is to adopt a Regulation providing that the approval of an active substance referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the Commission is to set the expiry date at the same date as before this Regulation or at the date of the entry into force of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As regards cases where the Commission is to adopt a Regulation providing for the renewal of an active substance referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the circumstances, the earliest possible application date.

| (7) | Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. |
| --- | --- |

(7)

Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.

| (8) | The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
| --- | --- |

(8)

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

The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.

Article 2

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

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

Done at Brussels, 18 March 2020.

For the Commission

The President

Ursula VON DER LEYEN

---

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

1

(2)  Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).

2

(3)  Commission Implementing Regulation (EU) 2019/168 of 31 January 2019 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances abamectin, Bacillus subtilis (Cohn 1872) Strain QST 713, Bacillus thuringiensis subsp. Aizawai, Bacillus thuringiensis subsp. israeliensis, Bacillus thuringiensis subsp. kurstaki, Beauveria bassiana, benfluralin, clodinafop, clopyralid, Cydia pomonella Granulovirus (CpGV), cyprodinil, dichlorprop-P, epoxiconazole, fenpyroximate, fluazinam, flutolanil, fosetyl, Lecanicillium muscarium, mepanipyrim, mepiquat, Metarhizium anisopliae var. Anisopliae, metconazole, metrafenone, Phlebiopsis gigantea, pirimicarb, Pseudomonas chlororaphis strain: MA 342, pyrimethanil, Pythium oligandrum, rimsulfuron, spinosad, Streptomyces K61, thiacloprid, tolclofos-methyl, Trichoderma asperellum, Trichoderma atroviride, Trichoderma gamsii, Trichoderma harzianum, triclopyr, trinexapac, triticonazole, Verticillium albo-atrum and ziram (OJ L 33, 5.2.2019, p. 1).

3

Bacillus subtilis

Bacillus thuringiensis

Bacillus thuringiensis

Bacillus thuringiensis

Beauveria bassiana

Cydia pomonella Granulovirus

Lecanicillium muscarium

Metarhizium anisopliae

Phlebiopsis gigantea

Pseudomonas chlororaphis

Pythium oligandrum

Streptomyces

Trichoderma asperellum

Trichoderma atroviride

Trichoderma gamsii

Trichoderma harzianum

Verticillium albo-atrum

(4)  Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).

4

---

ANNEX I

Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

| (1) | in the sixth column, expiration of approval, of row 74, Ziram, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(1)

in the sixth column, expiration of approval, of row 74, Ziram, the date is replaced by ‘30 April 2021’;

| (2) | in the sixth column, expiration of approval, of row 89, Pseudomonas chlororaphis strain MA 342, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(2)

in the sixth column, expiration of approval, of row 89, Pseudomonas chlororaphis strain MA 342, the date is replaced by ‘30 April 2021’;

| (3) | in the sixth column, expiration of approval, of row 90, Mepanipyrim, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(3)

in the sixth column, expiration of approval, of row 90, Mepanipyrim, the date is replaced by ‘30 April 2021’;

| (4) | in the sixth column, expiration of approval, of row 123, Clodinafop, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(4)

in the sixth column, expiration of approval, of row 123, Clodinafop, the date is replaced by ‘30 April 2021’;

| (5) | in the sixth column, expiration of approval, of row 124, Pirimicarb, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(5)

in the sixth column, expiration of approval, of row 124, Pirimicarb, the date is replaced by ‘30 April 2021’;

| (6) | in the sixth column, expiration of approval, of row 125, Rimsulfuron, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(6)

in the sixth column, expiration of approval, of row 125, Rimsulfuron, the date is replaced by ‘30 April 2021’;

| (7) | in the sixth column, expiration of approval, of row 127, Triticonazole, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(7)

in the sixth column, expiration of approval, of row 127, Triticonazole, the date is replaced by ‘30 April 2021’;

| (8) | in the sixth column, expiration of approval, of row 129, Clopyralid, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(8)

in the sixth column, expiration of approval, of row 129, Clopyralid, the date is replaced by ‘30 April 2021’;

| (9) | in the sixth column, expiration of approval, of row 130, Cyprodinil, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(9)

in the sixth column, expiration of approval, of row 130, Cyprodinil, the date is replaced by ‘30 April 2021’;

| (10) | in the sixth column, expiration of approval, of row 131, Fosetyl, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(10)

in the sixth column, expiration of approval, of row 131, Fosetyl, the date is replaced by ‘30 April 2021’;

| (11) | in the sixth column, expiration of approval, of row 132, Trinexapac, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(11)

in the sixth column, expiration of approval, of row 132, Trinexapac, the date is replaced by ‘30 April 2021’;

| (12) | in the sixth column, expiration of approval, of row 133, Dichlorprop-P, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(12)

in the sixth column, expiration of approval, of row 133, Dichlorprop-P, the date is replaced by ‘30 April 2021’;

| (13) | in the sixth column, expiration of approval, of row 134, Metconazole, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(13)

in the sixth column, expiration of approval, of row 134, Metconazole, the date is replaced by ‘30 April 2021’;

| (14) | in the sixth column, expiration of approval, of row 135, Pyrimethanil, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(14)

in the sixth column, expiration of approval, of row 135, Pyrimethanil, the date is replaced by ‘30 April 2021’;

| (15) | in the sixth column, expiration of approval, of row 136, Triclopyr, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(15)

in the sixth column, expiration of approval, of row 136, Triclopyr, the date is replaced by ‘30 April 2021’;

| (16) | in the sixth column, expiration of approval, of row 137, Metrafenone, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(16)

in the sixth column, expiration of approval, of row 137, Metrafenone, the date is replaced by ‘30 April 2021’;

| (17) | in the sixth column, expiration of approval, of row 138, Bacillus subtilis (Cohn 1872) strain QST 713, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(17)

in the sixth column, expiration of approval, of row 138, Bacillus subtilis (Cohn 1872) strain QST 713, the date is replaced by ‘30 April 2021’;

| (18) | in the sixth column, expiration of approval, of row 139, Spinosad, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(18)

in the sixth column, expiration of approval, of row 139, Spinosad, the date is replaced by ‘30 April 2021’;

| (19) | in the sixth column, expiration of approval, of row 193, Bacillus thuringiensis subsp. aizawai strain ABTS-1857 and strain GC-91, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(19)

in the sixth column, expiration of approval, of row 193, Bacillus thuringiensis subsp. aizawai strain ABTS-1857 and strain GC-91, the date is replaced by ‘30 April 2021’;

| (20) | in the sixth column, expiration of approval, of row 194, Bacillus thuringiensis subsp. israeliensis (serotype H-14) strain AM65-52, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(20)

in the sixth column, expiration of approval, of row 194, Bacillus thuringiensis subsp. israeliensis (serotype H-14) strain AM65-52, the date is replaced by ‘30 April 2021’;

| (21) | in the sixth column, expiration of approval, of row 195, Bacillus thuringiensis subsp. kurstaki strain ABTS 351, strain PB 54, strain SA 11, strain SA 12, strain EG 2348, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(21)

in the sixth column, expiration of approval, of row 195, Bacillus thuringiensis subsp. kurstaki strain ABTS 351, strain PB 54, strain SA 11, strain SA 12, strain EG 2348, the date is replaced by ‘30 April 2021’;

| (22) | in the sixth column, expiration of approval, of row 197, Beauveria bassiana strain ATCC 74040, strain GHA, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(22)

in the sixth column, expiration of approval, of row 197, Beauveria bassiana strain ATCC 74040, strain GHA, the date is replaced by ‘30 April 2021’;

| (23) | in the sixth column, expiration of approval, of row 198, Cydia pomonella Granulovirus (CpGV), the date is replaced by ‘30 April 2021’; |
| --- | --- |

(23)

in the sixth column, expiration of approval, of row 198, Cydia pomonella Granulovirus (CpGV), the date is replaced by ‘30 April 2021’;

| (24) | in the sixth column, expiration of approval, of row 199, Lecanicillium muscarium (formerly Verticilium lecanii) strain Ve 6, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(24)

in the sixth column, expiration of approval, of row 199, Lecanicillium muscarium (formerly Verticilium lecanii) strain Ve 6, the date is replaced by ‘30 April 2021’;

| (25) | in the sixth column, expiration of approval, of row 200, Metarhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) strain BIPESCO 5/F52, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(25)

in the sixth column, expiration of approval, of row 200, Metarhizium anisopliae var. anisopliae (formerly Metarhizium anisopliae) strain BIPESCO 5/F52, the date is replaced by ‘30 April 2021’;

| (26) | in the sixth column, expiration of approval, of row 201, Phlebiopsis gigantea strain VRA 1835, strain VRA 1984, strain FOC PG 410.3, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(26)

in the sixth column, expiration of approval, of row 201, Phlebiopsis gigantea strain VRA 1835, strain VRA 1984, strain FOC PG 410.3, the date is replaced by ‘30 April 2021’;

| (27) | in the sixth column, expiration of approval, of row 202, Pythium oligandrum strain M1, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(27)

in the sixth column, expiration of approval, of row 202, Pythium oligandrum strain M1, the date is replaced by ‘30 April 2021’;

| (28) | in the sixth column, expiration of approval, of row 203, Streptomyces K61 (formerly S. griseoviridis) strain K61, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(28)

in the sixth column, expiration of approval, of row 203, Streptomyces K61 (formerly S. griseoviridis) strain K61, the date is replaced by ‘30 April 2021’;

| (29) | in the sixth column, expiration of approval, of row 204, Trichoderma atroviride (formerly T. harzianum) strains IMI206040 and T11, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(29)

in the sixth column, expiration of approval, of row 204, Trichoderma atroviride (formerly T. harzianum) strains IMI206040 and T11, the date is replaced by ‘30 April 2021’;

| (30) | in the sixth column, expiration of approval, of row 206, Trichoderma harzianum Rifai strain T-22, strain ITEM 908, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(30)

in the sixth column, expiration of approval, of row 206, Trichoderma harzianum Rifai strain T-22, strain ITEM 908, the date is replaced by ‘30 April 2021’;

| (31) | in the sixth column, expiration of approval, of row 207, Trichoderma asperellum (formerly T. harzianum) strain ICC012, strain T25, strain TV1, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(31)

in the sixth column, expiration of approval, of row 207, Trichoderma asperellum (formerly T. harzianum) strain ICC012, strain T25, strain TV1, the date is replaced by ‘30 April 2021’;

| (32) | in the sixth column, expiration of approval, of row 208, Trichoderma gamsii (formerly T. viride) strain ICC080, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(32)

in the sixth column, expiration of approval, of row 208, Trichoderma gamsii (formerly T. viride) strain ICC080, the date is replaced by ‘30 April 2021’;

| (33) | in the sixth column, expiration of approval, of row 210, Abamectin, the date is replaced by ‘30 April 2021’; |
| --- | --- |

(33)

in the sixth column, expiration of approval, of row 210, Abamectin, the date is replaced by ‘30 April 2021’;

| (34) | in the sixth column, expiration of approval, of row 213, Fenpyroximate, the date is replaced by ‘30 April 2021’. |
| --- | --- |

(34)

in the sixth column, expiration of approval, of row 213, Fenpyroximate, the date is replaced by ‘30 April 2021’.

---

| 20.3.2020 | EN | Official Journal of the European Union | L 84/11 |
| --- | --- | --- | --- |

20.3.2020

EN

Official Journal of the European Union

L 84/11

---

COMMISSION REGULATION (EU) 2020/422

of 19 March 2020

amending Council Regulation (EC) No 297/95 as regards the adjustment of the fees of the European Medicines Agency to the inflation rate with effect from 1 April 2020

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (1), and in particular the fifth paragraph of Article 12 thereof,

Whereas:

| (1) | In accordance with Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2), the revenue of the European Medicines Agency consists of a contribution from the Union and fees paid by undertakings to that Agency. Regulation (EC) No 297/95 lays down the categories and levels of such fees. |
| --- | --- |

(1)

In accordance with Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2), the revenue of the European Medicines Agency consists of a contribution from the Union and fees paid by undertakings to that Agency. Regulation (EC) No 297/95 lays down the categories and levels of such fees.

| (2) | Those fees should be updated by reference to the inflation rate of 2019. The inflation rate in the Union, as published by the Statistical Office of the European Union (3), was 1,6 % in 2019. |
| --- | --- |

(2)

Those fees should be updated by reference to the inflation rate of 2019. The inflation rate in the Union, as published by the Statistical Office of the European Union (3), was 1,6 % in 2019.

| (3) | For the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100. |
| --- | --- |

(3)

For the sake of simplicity, the adjusted levels of the fees should be rounded to the nearest EUR 100.

| (4) | Regulation (EC) No 297/95 should therefore be amended accordingly. |
| --- | --- |

(4)

Regulation (EC) No 297/95 should therefore be amended accordingly.

| (5) | For reasons of legal certainty, this Regulation should not apply to valid applications which are pending on 1 April 2020. |
| --- | --- |

(5)

For reasons of legal certainty, this Regulation should not apply to valid applications which are pending on 1 April 2020.

| (6) | In accordance with Article 12 of Regulation (EC) No 297/95, the update is to be made with effect from 1 April 2020. It is therefore appropriate that this Regulation enters into force as a matter of urgency and applies from that date, |
| --- | --- |

(6)

In accordance with Article 12 of Regulation (EC) No 297/95, the update is to be made with effect from 1 April 2020. It is therefore appropriate that this Regulation enters into force as a matter of urgency and applies from that date,

HAS ADOPTED THIS REGULATION:

Article 1

Regulation (EC) No 297/95 is amended as follows:

| (1) | Article 3 is amended as follows:






  (a) | paragraph 1 is amended as follows:






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






  — | in the first subparagraph, ‘EUR 291 800
  ’ is replaced by ‘EUR 296 500
  ’; |
| --- | --- | --- | --- | --- |

(1)

Article 3 is amended as follows:

(a)

paragraph 1 is amended as follows:

(i)

point (a) is amended as follows:

—

in the first subparagraph, ‘EUR 291 800
  ’ is replaced by ‘EUR 296 500
  ’;

| — | in the second subparagraph, ‘EUR 29 300
  ’ is replaced by ‘EUR 29 800
  ’; |
| --- | --- |

—

in the second subparagraph, ‘EUR 29 300
  ’ is replaced by ‘EUR 29 800
  ’;

| — | in the third subparagraph, ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’; |
| --- | --- |

—

in the third subparagraph, ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’;

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






  — | in the first subparagraph, ‘EUR 113 300
  ’ is replaced by ‘EUR 115 100
  ’; |
| --- | --- | --- |

(ii)

point (b) is amended as follows:

—

in the first subparagraph, ‘EUR 113 300
  ’ is replaced by ‘EUR 115 100
  ’;

| — | in the second subparagraph, ‘EUR 188 700
  ’ is replaced by ‘EUR 191 700
  ’; |
| --- | --- |

—

in the second subparagraph, ‘EUR 188 700
  ’ is replaced by ‘EUR 191 700
  ’;

| — | in the third subparagraph, ‘EUR 11 300
  ’ is replaced by ‘EUR 11 500
  ’; |
| --- | --- |

—

in the third subparagraph, ‘EUR 11 300
  ’ is replaced by ‘EUR 11 500
  ’;

| — | in the fourth subparagraph, ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’; |
| --- | --- |

—

in the fourth subparagraph, ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’;

| (iii) | point (c) is amended as follows:






  — | in the first subparagraph, ‘EUR 87 600
  ’ is replaced by ‘EUR 89 000
  ’; |
| --- | --- | --- |

(iii)

point (c) is amended as follows:

—

in the first subparagraph, ‘EUR 87 600
  ’ is replaced by ‘EUR 89 000
  ’;

| — | in the second subparagraph, ‘EUR 22 000 to EUR 65 700
  ’ is replaced by ‘EUR 22 400 to EUR 66 800
  ’; |
| --- | --- |

—

in the second subparagraph, ‘EUR 22 000 to EUR 65 700
  ’ is replaced by ‘EUR 22 400 to EUR 66 800
  ’;

| — | in the third subparagraph, ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’; |
| --- | --- |

—

in the third subparagraph, ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’;

| (b) | paragraph 2 is amended as follows:






  (i) | the first subparagraph of point (a) is amended as follows:






  — | ‘EUR 3 200
  ’ is replaced by ‘EUR 3 300
  ’; |
| --- | --- | --- | --- |

(b)

paragraph 2 is amended as follows:

(i)

the first subparagraph of point (a) is amended as follows:

—

‘EUR 3 200
  ’ is replaced by ‘EUR 3 300
  ’;

| — | ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’; |
| --- | --- |

—

‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’;

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






  — | in the first subparagraph, ‘EUR 87 600
  ’ is replaced by ‘EUR 89 000
  ’; |
| --- | --- | --- |

(ii)

point (b) is amended as follows:

—

in the first subparagraph, ‘EUR 87 600
  ’ is replaced by ‘EUR 89 000
  ’;

| — | in the second subparagraph, ‘EUR 22 000 to EUR 65 700
  ’ is replaced by ‘EUR 22 400 to EUR 66 800
  ’; |
| --- | --- |

—

in the second subparagraph, ‘EUR 22 000 to EUR 65 700
  ’ is replaced by ‘EUR 22 400 to EUR 66 800
  ’;

| (c) | in paragraph 3, ‘EUR 14 400’ is replaced by ‘EUR 14 600’; |
| --- | --- |

(c)

in paragraph 3, ‘EUR 14 400’ is replaced by ‘EUR 14 600’;

| (d) | in the first subparagraph of paragraph 4, ‘EUR 22 000’ is replaced by ‘EUR 22 400’; |
| --- | --- |

(d)

in the first subparagraph of paragraph 4, ‘EUR 22 000’ is replaced by ‘EUR 22 400’;

| (e) | in paragraph 5, ‘EUR 7 300’ is replaced by ‘EUR 7 400’; |
| --- | --- |

(e)

in paragraph 5, ‘EUR 7 300’ is replaced by ‘EUR 7 400’;

| (f) | paragraph 6 is amended as follows:






  (i) | in the first subparagraph, ‘EUR 104 600’ is replaced by ‘EUR 106 300’; |
| --- | --- | --- |

(f)

paragraph 6 is amended as follows:

(i)

in the first subparagraph, ‘EUR 104 600’ is replaced by ‘EUR 106 300’;

| (ii) | in the second subparagraph, ‘EUR 26 000 to EUR 78 400’ is replaced by ‘EUR 26 400 to EUR 79 700’; |
| --- | --- |

(ii)

in the second subparagraph, ‘EUR 26 000 to EUR 78 400’ is replaced by ‘EUR 26 400 to EUR 79 700’;

| (2) | in the first paragraph of Article 4, ‘EUR 72 600’ is replaced by ‘EUR 73 800’; |
| --- | --- |

(2)

in the first paragraph of Article 4, ‘EUR 72 600’ is replaced by ‘EUR 73 800’;

| (3) | Article 5 is amended as follows:






  (a) | paragraph 1 is amended as follows:






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






  — | in the first subparagraph, ‘EUR 146 100
  ’ is replaced by ‘EUR 148 400
  ’; |
| --- | --- | --- | --- | --- |

(3)

Article 5 is amended as follows:

(a)

paragraph 1 is amended as follows:

(i)

point (a) is amended as follows:

—

in the first subparagraph, ‘EUR 146 100
  ’ is replaced by ‘EUR 148 400
  ’;

| — | in the second subparagraph, ‘EUR 14 400
  ’ is replaced by ‘EUR 14 600
  ’; |
| --- | --- |

—

in the second subparagraph, ‘EUR 14 400
  ’ is replaced by ‘EUR 14 600
  ’;

| — | in the third subparagraph, ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’; |
| --- | --- |

—

in the third subparagraph, ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’;

| — | the fourth subparagraph is amended as follows:






  — | ‘EUR 72 600
  ’ is replaced by ‘EUR 73 800
  ’; |
| --- | --- | --- |

—

the fourth subparagraph is amended as follows:

—

‘EUR 72 600
  ’ is replaced by ‘EUR 73 800
  ’;

| — | ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’; |
| --- | --- |

—

‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’;

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






  — | in the first subparagraph, ‘EUR 72 600
  ’ is replaced by ‘EUR 73 800
  ’; |
| --- | --- | --- |

(ii)

point (b) is amended as follows:

—

in the first subparagraph, ‘EUR 72 600
  ’ is replaced by ‘EUR 73 800
  ’;

| — | in the second subparagraph, ‘EUR 123 300
  ’ is replaced by ‘EUR 125 300
  ’; |
| --- | --- |

—

in the second subparagraph, ‘EUR 123 300
  ’ is replaced by ‘EUR 125 300
  ’;

| — | in the third subparagraph, ‘EUR 14 400
  ’ is replaced by ‘EUR 14 600
  ’; |
| --- | --- |

—

in the third subparagraph, ‘EUR 14 400
  ’ is replaced by ‘EUR 14 600
  ’;

| — | in the fourth subparagraph, ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’; |
| --- | --- |

—

in the fourth subparagraph, ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’;

| — | the fifth subparagraph is amended as follows:






  — | ‘EUR 36 500
  ’ is replaced by ‘EUR 37 100
  ’; |
| --- | --- | --- |

—

the fifth subparagraph is amended as follows:

—

‘EUR 36 500
  ’ is replaced by ‘EUR 37 100
  ’;

| — | ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’; |
| --- | --- |

—

‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’;

| (iii) | point (c) is amended as follows:






  — | in the first subparagraph, ‘EUR 36 500
  ’ is replaced by ‘EUR 37 100
  ’; |
| --- | --- | --- |

(iii)

point (c) is amended as follows:

—

in the first subparagraph, ‘EUR 36 500
  ’ is replaced by ‘EUR 37 100
  ’;

| — | in the second subparagraph, ‘EUR 9 100 to EUR 27 500
  ’ is replaced by ‘EUR 9 200 to EUR 27 900
  ’; |
| --- | --- |

—

in the second subparagraph, ‘EUR 9 100 to EUR 27 500
  ’ is replaced by ‘EUR 9 200 to EUR 27 900
  ’;

| — | in the third subparagraph, ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’; |
| --- | --- |

—

in the third subparagraph, ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’;

| (b) | paragraph 2 is amended as follows:






  (i) | the first subparagraph of point (a) is amended as follows:






  — | ‘EUR 3 200
  ’ is replaced by ‘EUR 3 300
  ’; |
| --- | --- | --- | --- |

(b)

paragraph 2 is amended as follows:

(i)

the first subparagraph of point (a) is amended as follows:

—

‘EUR 3 200
  ’ is replaced by ‘EUR 3 300
  ’;

| — | ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’; |
| --- | --- |

—

‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’;

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






  — | in the first subparagraph, ‘EUR 43 700
  ’ is replaced by ‘EUR 44 400
  ’; |
| --- | --- | --- |

(ii)

point (b) is amended as follows:

—

in the first subparagraph, ‘EUR 43 700
  ’ is replaced by ‘EUR 44 400
  ’;

| — | in the second subparagraph, ‘EUR 11 000 to EUR 33 000
  ’ is replaced by ‘EUR 11 200 to EUR 33 500
  ’; |
| --- | --- |

—

in the second subparagraph, ‘EUR 11 000 to EUR 33 000
  ’ is replaced by ‘EUR 11 200 to EUR 33 500
  ’;

| — | in the third subparagraph, ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’; |
| --- | --- |

—

in the third subparagraph, ‘EUR 7 300
  ’ is replaced by ‘EUR 7 400
  ’;

| (c) | in paragraph 3, ‘EUR 7 300’ is replaced by ‘EUR 7 400’; |
| --- | --- |

(c)

in paragraph 3, ‘EUR 7 300’ is replaced by ‘EUR 7 400’;

| (d) | in the first subparagraph of paragraph 4, ‘EUR 22 000’ is replaced by ‘EUR 22 400’; |
| --- | --- |

(d)

in the first subparagraph of paragraph 4, ‘EUR 22 000’ is replaced by ‘EUR 22 400’;

| (e) | in paragraph 5, ‘EUR 7 300’ is replaced by ‘EUR 7 400’; |
| --- | --- |

(e)

in paragraph 5, ‘EUR 7 300’ is replaced by ‘EUR 7 400’;

| (f) | paragraph 6 is amended as follows:






  (i) | in the first subparagraph, ‘EUR 35 000’ is replaced by ‘EUR 35 600’; |
| --- | --- | --- |

(f)

paragraph 6 is amended as follows:

(i)

in the first subparagraph, ‘EUR 35 000’ is replaced by ‘EUR 35 600’;

| (ii) | in the second subparagraph, ‘EUR 8 600 to EUR 26 000’ is replaced by ‘EUR 8 700 to EUR 26 400’; |
| --- | --- |

(ii)

in the second subparagraph, ‘EUR 8 600 to EUR 26 000’ is replaced by ‘EUR 8 700 to EUR 26 400’;

| (4) | in the first paragraph of Article 6, ‘EUR 43 700’ is replaced by ‘EUR 44 400’; |
| --- | --- |

(4)

in the first paragraph of Article 6, ‘EUR 43 700’ is replaced by ‘EUR 44 400’;

| (5) | Article 7 is amended as follows:






  (a) | in the first paragraph, ‘EUR 72 600’ is replaced by ‘EUR 73 800’; |
| --- | --- | --- |

(5)

Article 7 is amended as follows:

(a)

in the first paragraph, ‘EUR 72 600’ is replaced by ‘EUR 73 800’;

| (b) | in the second paragraph, ‘EUR 22 000’ is replaced by ‘EUR 22 400’; |
| --- | --- |

(b)

in the second paragraph, ‘EUR 22 000’ is replaced by ‘EUR 22 400’;

| (6) | Article 8 is amended as follows:






  (a) | paragraph 1 is amended as follows:






  (i) | in the second subparagraph, ‘EUR 87 600’ is replaced by ‘EUR 89 000’; |
| --- | --- | --- | --- |

(6)

Article 8 is amended as follows:

(a)

paragraph 1 is amended as follows:

(i)

in the second subparagraph, ‘EUR 87 600’ is replaced by ‘EUR 89 000’;

| (ii) | in the third subparagraph, ‘EUR 43 700’ is replaced by ‘EUR 44 400’; |
| --- | --- |

(ii)

in the third subparagraph, ‘EUR 43 700’ is replaced by ‘EUR 44 400’;

| (iii) | in the fourth subparagraph, ‘EUR 22 000 to EUR 65 700’ is replaced by ‘EUR 22 400 to EUR 66 800’; |
| --- | --- |

(iii)

in the fourth subparagraph, ‘EUR 22 000 to EUR 65 700’ is replaced by ‘EUR 22 400 to EUR 66 800’;

| (iv) | in the fifth subparagraph, ‘EUR 11 000 to EUR 33 000’ is replaced by ‘EUR 11 200 to EUR 33 500’; |
| --- | --- |

(iv)

in the fifth subparagraph, ‘EUR 11 000 to EUR 33 000’ is replaced by ‘EUR 11 200 to EUR 33 500’;

| (b) | paragraph 2 is amended as follows:






  (i) | in the second subparagraph, ‘EUR 291 800’ is replaced by ‘EUR 296 500’; |
| --- | --- | --- |

(b)

paragraph 2 is amended as follows:

(i)

in the second subparagraph, ‘EUR 291 800’ is replaced by ‘EUR 296 500’;

| (ii) | in the third subparagraph, ‘EUR 146 100’ is replaced by ‘EUR 148 400’; |
| --- | --- |

(ii)

in the third subparagraph, ‘EUR 146 100’ is replaced by ‘EUR 148 400’;

| (iii) | in the fifth subparagraph, ‘EUR 3 200 to EUR 251 500’ is replaced by ‘EUR 3 300 to EUR 255 500’; |
| --- | --- |

(iii)

in the fifth subparagraph, ‘EUR 3 200 to EUR 251 500’ is replaced by ‘EUR 3 300 to EUR 255 500’;

| (iv) | in the sixth subparagraph, ‘EUR 3 200 to EUR 125 900’ is replaced by ‘EUR 3 300 to EUR 127 900’; |
| --- | --- |

(iv)

in the sixth subparagraph, ‘EUR 3 200 to EUR 125 900’ is replaced by ‘EUR 3 300 to EUR 127 900’;

| (c) | in the first subparagraph of paragraph 3, ‘EUR 7 300’ is replaced by ‘EUR 7 400’. |
| --- | --- |

(c)

in the first subparagraph of paragraph 3, ‘EUR 7 300’ is replaced by ‘EUR 7 400’.

Article 2

This Regulation shall not apply to valid applications pending on 1 April 2020.

Article 3

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 April 2020.

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

Done at Brussels, 19 March 2020.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 35, 15.2.1995, p. 1.

1

(2)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

2

(3)  https://ec.europa.eu/eurostat/documents/2995521/10159211/2-17012020-AP-EN.pdf

3

---

| 20.3.2020 | EN | Official Journal of the European Union | L 84/15 |
| --- | --- | --- | --- |

20.3.2020

EN

Official Journal of the European Union

L 84/15

---

COMMISSION IMPLEMENTING REGULATION (EU) 2020/423

of 19 March 2020

amending Regulation (EC) No 1010/2009 as regards administrative arrangements with third countries on catch certificates for marine fisheries products

THE EUROPEAN COMMISSION,

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

Having regard to Council Regulation (EC) No 1005/2008 of 29 September 2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing (1), and in particular Article 20(4) thereof,

Whereas:

| (1) | Administrative arrangements with third countries on catch certificates for fisheries products are listed in Annex IX to Commission Regulation (EC) No 1010/2009 (2). These arrangements include specimens of the catch certificates validated by the competent authorities of the third countries concerned. |
| --- | --- |

(1)

Administrative arrangements with third countries on catch certificates for fisheries products are listed in Annex IX to Commission Regulation (EC) No 1010/2009 (2). These arrangements include specimens of the catch certificates validated by the competent authorities of the third countries concerned.

| (2) | The United States have revised the United States catch certificate specimen in view particularly of the new IT tool, CATCH, developed by the Commission for the Union catch certification scheme. |
| --- | --- |

(2)

The United States have revised the United States catch certificate specimen in view particularly of the new IT tool, CATCH, developed by the Commission for the Union catch certification scheme.

| (3) | Annex IX to Regulation (EC) No 1010/2009 should be amended accordingly. |
| --- | --- |

(3)

Annex IX to Regulation (EC) No 1010/2009 should be amended accordingly.

| (4) | The measures provided for in this Regulation are in accordance with the opinion of the Committee for Fisheries and Aquaculture, |
| --- | --- |

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Committee for Fisheries and Aquaculture,

HAS ADOPTED THIS REGULATION:

Article 1

Annex IX to Regulation (EC) No 1010/2009 is amended as set out in the Annex to this Regulation.

Article 2

Entry into force

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

Official Journal of the European Union

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

Done at Brussels, 19 March 2020.

For the Commission

The President

Ursula VON DER LEYEN

---

(1)  
  OJ L 286, 29.10.2008, p. 1.

1

(2)  Commission Regulation (EC) No 1010/2009 of 22 October 2009 laying down detailed rules for the implementation of Council Regulation (EC) No 1005/2008 establishing a Community system to prevent, deter and eliminate illegal, unreported and unregulated fishing (OJ L 280, 27.10.2009, p. 5).

2

---

ANNEX

In Annex IX to Regulation (EC) No 1010/2009, Section 2 is replaced by the following:

‘
  Section 2

UNITED STATES

CATCH CERTIFICATION SCHEME

In accordance with Article 12(4) of Regulation (EC) No 1005/2008, the catch certificate provided for in Article 12 and Annex II of Regulation (EC) No 1005/2008 shall be replaced – for fisheries products obtained from catches made by fishing vessels flying the flag of the United States – by the U.S. catch certificate based on the U.S. Catch Certification System (described in Appendix 2) which is an electronic reporting and record keeping system under the control of the U.S. authorities ensuring the same level of control by authorities as required under the European Union catch certification scheme.

A specimen of the U.S. catch certificate, which shall replace the European Union Catch Certificate and Re-export Certificate, is provided in Appendix 1. This revised U.S. catch certificate may cover fisheries products obtained from catches made by single vessels or groups of vessels as described in Appendix 2.

MUTUAL ASSISTANCE

Mutual assistance under Article 51 of Regulation (EC) No 1005/2008 shall be developed to facilitate the exchange of information and administrative cooperation between respective competent authorities in the United States and Member States of the European Union, based on the detailed rules on mutual assistance laid down in Regulation (EC) No 1010/2009.

Appendix 1

Image 1

Image 2

Appendix 2

The U.S. Catch Documentation Scheme, as revised in 2019, is designed to issue a single form of catch certificate for export consignments from the United States to the European Union (EU) of fishery products, raw and processed.

On the U.S. catch certificate, U.S. exporters will be required to 1) list the single vessel responsible for the harvest of fish or fisheries products comprising the respective consignment with all of the applicable information required on the United States Attestation of Legal Catch; or 2) provide a vessel grouping name responsible for the harvest of fish or fisheries products comprising the respective consignment with all of the applicable information required on the United States Attestation of Legal Catch.

The grouping feature will be used for fisheries subject to significant commingling of catch at-sea or on-shore (for example, fisheries including but not limited to: those where initial catches are divided by size before further dispatch e.g., lobster; or those in which multiple harvest vessels deliver fish to tender vessels at sea).

Groupings will be managed by the U.S. producer or processor requesting the certificate and subject to audit. Reflecting current U.S. practices, the U.S. producer or processor will be responsible for retaining all information corresponding to the vessels or list of vessels which contributed to the consignment and providing that information to the U.S. Government competent authority upon request.

The single vessel or grouping feature will enable the United States to produce a single certificate per shipment while having access to the complete vessel information behind each shipment.

This information will be available to authorities in importing Member States upon request to the U.S. Government competent authority.

---

| 20.3.2020 | EN | Official Journal of the European Union | L 84/20 |
| --- | --- | --- | --- |

20.3.2020

EN

Official Journal of the European Union

L 84/20

---

COMMISSION IMPLEMENTING REGULATION (EU) 2020/424

of 19 March 2020

on submitting information to the Commission as regards non-application of technical specifications for interoperability in accordance with Directive (EU) 2016/797

THE EUROPEAN COMMISSION,

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

Having regard to Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (1), and in particular Article 7(5) thereof,

Whereas:

| (1) | Article 7(1) of the Directive (EU) 2016/797 provides that Member States may allow an applicant not to apply one or more technical specifications for interoperability (‘TSIs’) or part of them, in cases, which are listed exhaustively in points (a) to (e) of the Article. |
| --- | --- |

(1)

Article 7(1) of the Directive (EU) 2016/797 provides that Member States may allow an applicant not to apply one or more technical specifications for interoperability (‘TSIs’) or part of them, in cases, which are listed exhaustively in points (a) to (e) of the Article.

| (2) | Member States’ communication of their decision in cases referred to in point (a) of Article 7(1), or Member States’ request for non-application in the cases referred to in points (c), (d) and (e), should contain information justifying the non-application and specifying the alternative provisions to be applied instead of the TSIs. |
| --- | --- |

(2)

Member States’ communication of their decision in cases referred to in point (a) of Article 7(1), or Member States’ request for non-application in the cases referred to in points (c), (d) and (e), should contain information justifying the non-application and specifying the alternative provisions to be applied instead of the TSIs.

| (3) | The request should include the reference to the non-applied TSI provisions, describe the project concerned, its scope and timelines as well as provide any other relevant information to assist the Commission in assessing the compliance of the non-application with the requirements set out in Article 7(1). |
| --- | --- |

(3)

The request should include the reference to the non-applied TSI provisions, describe the project concerned, its scope and timelines as well as provide any other relevant information to assist the Commission in assessing the compliance of the non-application with the requirements set out in Article 7(1).

| (4) | Once transitional measures provided by a TSI expire, Member States should permit applicants not to apply the TSI or parts of them pursuant to Article 7(1)(a) of the Directive only in duly justified case. In that event, the communication to the Commission should include all necessary information and justifications. |
| --- | --- |

(4)

Once transitional measures provided by a TSI expire, Member States should permit applicants not to apply the TSI or parts of them pursuant to Article 7(1)(a) of the Directive only in duly justified case. In that event, the communication to the Commission should include all necessary information and justifications.

| (5) | In order to facilitate communication with the Commission, Member States should use a template when they submit their non-application decision for a project at an advanced stage of development pursuant to point (a) of Article 7(1). This template could also be used for the notification of a list of projects at an advanced stage of development pursuant to Article 7(2) of the Directive. |
| --- | --- |

(5)

In order to facilitate communication with the Commission, Member States should use a template when they submit their non-application decision for a project at an advanced stage of development pursuant to point (a) of Article 7(1). This template could also be used for the notification of a list of projects at an advanced stage of development pursuant to Article 7(2) of the Directive.

| (6) | The request for non-application of one or more TSIs or parts of them should be sent to the Commission by electronic means in order to ensure a paperless administration. The date by which Member States are delivering a request or supplement information to the Commission’s mailbox should be the submission date for the purpose of Article 7(7) of the Directive. |
| --- | --- |

(6)

The request for non-application of one or more TSIs or parts of them should be sent to the Commission by electronic means in order to ensure a paperless administration. The date by which Member States are delivering a request or supplement information to the Commission’s mailbox should be the submission date for the purpose of Article 7(7) of the Directive.

| (7) | The measures provided for in this Regulation are in accordance with the opinion of the Rail Interoperability and Safety Committee, |
| --- | --- |

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Rail Interoperability and Safety Committee,

HAS ADOPTED THIS REGULATION:

Article 1

Scope

This Regulation establishes the information to be included in, and the format and the method to be used for the transmission of a request for non-application of one or more technical specifications for interoperability (‘TSIs’) or parts of them within the meaning of Article 7(4) of Directive (EU) 2016/797 (hereafter ‘request for non-application’), in accordance to which Member States shall either, communicate to the Commission a decision of non-application under point (a), or submit to the Commission a request for non-application under points (c), (d) or (e) of Article 7(1) of the Directive.

Article 2

Information contained in the request for non-application

1.   A request for non-application shall contain the following information:

| (a) | a reference to the case referred to in Article 7(1) of Directive (EU) 2016/797 under which the non-application is considered to be justified; |
| --- | --- |

(a)

a reference to the case referred to in Article 7(1) of Directive (EU) 2016/797 under which the non-application is considered to be justified;

| (b) | the reference to the title(s) of the TSI or TSIs covered by the request for non-application and to the provision(s) not applied. Each reference shall include, where relevant for assessing compliance, the time period or an estimate thereof, during which the non-application will continue; |
| --- | --- |

(b)

the reference to the title(s) of the TSI or TSIs covered by the request for non-application and to the provision(s) not applied. Each reference shall include, where relevant for assessing compliance, the time period or an estimate thereof, during which the non-application will continue;

| (c) | the essential details of the project concerned, consisting of the technical, operational and geographical elements of the project, including a detailed description of the subsystem, vehicle or infrastructure requested to benefit from the non-application, and relevant key dates, or any other details distinguishing it from other projects; |
| --- | --- |

(c)

the essential details of the project concerned, consisting of the technical, operational and geographical elements of the project, including a detailed description of the subsystem, vehicle or infrastructure requested to benefit from the non-application, and relevant key dates, or any other details distinguishing it from other projects;

| (d) | a reference to and details of the alternative provisions that the Member State intends to apply to compensate each non-application in the light of relevant essential requirements, including the measures to be taken to monitor their implementation and, where operational alternatives were agreed, their continuous application; |
| --- | --- |

(d)

a reference to and details of the alternative provisions that the Member State intends to apply to compensate each non-application in the light of relevant essential requirements, including the measures to be taken to monitor their implementation and, where operational alternatives were agreed, their continuous application;

| (e) | where more than one Member State is concerned, information on coordination taking place in accordance with the final sentence in Article 7(4) of Directive (EU) 2016/797 and/or Article 17(2) of Commission Implementing Regulation (EU) 2018/545 (2), when requests for non-application are linked to vehicle authorisations; the same information shall be provided for cross border infrastructure projects; |
| --- | --- |

(e)

where more than one Member State is concerned, information on coordination taking place in accordance with the final sentence in Article 7(4) of Directive (EU) 2016/797 and/or Article 17(2) of Commission Implementing Regulation (EU) 2018/545 (2), when requests for non-application are linked to vehicle authorisations; the same information shall be provided for cross border infrastructure projects;

| (f) | an economic or technical analysis or both, ensuring that the non-application is justified and limited to the extent necessary under the particular circumstances. |
| --- | --- |

(f)

an economic or technical analysis or both, ensuring that the non-application is justified and limited to the extent necessary under the particular circumstances.

2.   The request for non-application shall also provide the following specific information:

| (a) | for requests made pursuant to point (a) of Article 7(1) of Directive (EU) 2016/797, the justification shall include:






  (i) | the details of the project concerned, using the template established in the Annex. If the project is already on a list of advanced stage of development drawn up according to the same template, Member States may refer to it without having to re-submit the information already provided. The information shall be updated where relevant; |
| --- | --- | --- |

(a)

for requests made pursuant to point (a) of Article 7(1) of Directive (EU) 2016/797, the justification shall include:

(i)

the details of the project concerned, using the template established in the Annex. If the project is already on a list of advanced stage of development drawn up according to the same template, Member States may refer to it without having to re-submit the information already provided. The information shall be updated where relevant;

| (ii) | evidence that the project is at an advanced stage of development or subject to a contract in course of performance, with documentation providing the evidence for relevant dates and scope of the project; |
| --- | --- |

(ii)

evidence that the project is at an advanced stage of development or subject to a contract in course of performance, with documentation providing the evidence for relevant dates and scope of the project;

| (iii) | evidence that the planning or construction stage of a project at an advanced stage of development has reached a point where a change in the technical specifications may compromise the viability of the project as planned, in accordance with the definition of ‘project at advanced stage of development’ in Article 2(23) of Directive (EU) 2016/797; |
| --- | --- |

(iii)

evidence that the planning or construction stage of a project at an advanced stage of development has reached a point where a change in the technical specifications may compromise the viability of the project as planned, in accordance with the definition of ‘project at advanced stage of development’ in Article 2(23) of Directive (EU) 2016/797;

| (b) | for requests made pursuant to point (c) of Article 7(1) of Directive (EU) 2016/797, the justification shall include, depending on the nature of the non-application requested:






  (i) | evidence that the application of one or more TSIs or part of them compromises the economic viability of the project. This evidence shall include a thorough economic analysis establishing unavoidable costs of compliance with the TSI, and providing evidence that such cost would render the project unviable. The analysis shall take into account exploitation revenue if the non-application allows earlier deployment and the longer term economic viability of the project within the national and European rail system; and/or |
| --- | --- | --- |

(b)

for requests made pursuant to point (c) of Article 7(1) of Directive (EU) 2016/797, the justification shall include, depending on the nature of the non-application requested:

(i)

evidence that the application of one or more TSIs or part of them compromises the economic viability of the project. This evidence shall include a thorough economic analysis establishing unavoidable costs of compliance with the TSI, and providing evidence that such cost would render the project unviable. The analysis shall take into account exploitation revenue if the non-application allows earlier deployment and the longer term economic viability of the project within the national and European rail system; and/or

| (ii) | evidence of the technical details justifying the negative impact of the application of one or more TSIs or part of them, on the project’s technical compatibility with the national rail system; |
| --- | --- |

(ii)

evidence of the technical details justifying the negative impact of the application of one or more TSIs or part of them, on the project’s technical compatibility with the national rail system;

| (c) | for requests made pursuant to point (d) of Article 7(1) of Directive (EU) 2016/797, the justification shall include a list of the Member States and third countries concerned and the railway lines where the vehicles covered by the request are circulating; |
| --- | --- |

(c)

for requests made pursuant to point (d) of Article 7(1) of Directive (EU) 2016/797, the justification shall include a list of the Member States and third countries concerned and the railway lines where the vehicles covered by the request are circulating;

| (d) | for requests made pursuant to point (e) Article 7(1), the justification shall identify the network or network area(s) relevant for the request and justify its separation from the rail network of the rest of the Union, and/or its isolation. |
| --- | --- |

(d)

for requests made pursuant to point (e) Article 7(1), the justification shall identify the network or network area(s) relevant for the request and justify its separation from the rail network of the rest of the Union, and/or its isolation.

Article 3

Format and method of transmission

1.   The request for non-application shall be limited to 10 pages maximum. Supplementing information may be added through annexes to the request.

2.   A communication or request for non-application and any subsequent information to complete the file shall be submitted by electronic means only, to the dedicated mail address of the Commission:

MOVE-RAIL-DEROGATIONS@ec.europa.eu

3.   The date for the purpose of Article 7(7) of Directive (EU) 2016/797 is the date when the request or subsequent information to complete the file was submitted by mail according to paragraph 2.

4.   The acknowledgement of receipt issued by the Commission to the Member State within 7 days will contain a unique identifier with reference to the Member State concerned, the project and the year of submission.

Member State shall refer to the unique identifier, whenever communicating with the Commission on the non-application case.

Article 4

Entry into force

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

Official Journal of the European Union

This Regulation shall apply from 16 September 2020.

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

Done at Brussels, 19 March 2020.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 138, 26.5.2016, p. 44.

1

(2)  Commission Implementing Regulation (EU) 2018/545 of 4 April 2018 establishing practical arrangements for the railway vehicle authorisation and railway vehicle type authorisation process pursuant to Directive (EU) 2016/797 of the European Parliament and of the Council (OJ L 90, 6.4.2018, p. 66).

2

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ANNEX

Template for presenting a project at an advanced stage of development where the non-application of one or more TSIs or part of them is requested for this project under point (a) of Article 7(1) of Directive (EU) 2016/797 and in line with the information requested with Article 2, points 1. and 2(a) of this Regulation

| Name of the project | Details concerning the scope of the project | All dates and actions relevant for justifying the advanced state of development character or the contract signed | Technical specifications not applied and alternative provisions and/or standards applied | Any other relevant information, such as area(s) of use, including coordination in accordance with Art. 17(2) of Implementing Regulation (EU) 2018/545. | Information to justify the non-viability of the project | Derogations already granted to that project (if any) |
| --- | --- | --- | --- | --- | --- | --- |

Name of the project

Details concerning the scope of the project

All dates and actions relevant for justifying the advanced state of development character or the contract signed

Technical specifications not applied and alternative provisions and/or standards applied

Any other relevant information, such as area(s) of use, including coordination in accordance with Art. 17(2) of Implementing Regulation (EU) 2018/545.

Information to justify the non-viability of the project

Derogations already granted to that project (if any)

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Corrigenda

| 20.3.2020 | EN | Official Journal of the European Union | L 84/24 |
| --- | --- | --- | --- |

20.3.2020

EN

Official Journal of the European Union

L 84/24

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Corrigendum to Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat

(
  Official Journal of the European Union L 79I of 16 March 2020
  )

In recital 21, on page 3:

for:

‘According to Article 26(4) and point 7(f) of Annex V of Regulation (EU) 2016/425’,

read:

‘According to Article 24(6) and point 4(f) of Annex V of Regulation (EU) 2016/425’.

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