# L_2021345EN.01003401.xml

| 30.9.2021 | EN | Official Journal of the European Union | L 345/34 |
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30.9.2021

EN

Official Journal of the European Union

L 345/34

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COMMISSION IMPLEMENTING REGULATION (EU) 2021/1728

of 29 September 2021

amending Implementing Regulation (EU) 2021/442 and Implementing Regulation (EU) 2021/521 related to the mechanism making certain products subject to the production of an export authorisation

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) 2015/479 of the European Parliament and of the Council of 11 March 2015 on common rules for exports (1), and in particular Article 6 thereof,

Whereas:

| (1) | On 30 January 2021, the Commission adopted Implementing Regulation (EU) 2021/111 (2) making the exportation of COVID-19 vaccines as well as active substances, including master and working cell banks, used to manufacture these vaccines, subject to the production of an export authorisation, pursuant to Article 5 of Regulation (EU) 2015/479, for a period of six weeks. Hereafter, on 12 March 2021, the Commission adopted Implementing Regulation (EU) 2021/442 (3) making the exportation of the same products subject to an export authorisation until 30 June 2021, pursuant to Article 6 of Regulation (EU) 2015/479. |
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(1)

On 30 January 2021, the Commission adopted Implementing Regulation (EU) 2021/111 (2) making the exportation of COVID-19 vaccines as well as active substances, including master and working cell banks, used to manufacture these vaccines, subject to the production of an export authorisation, pursuant to Article 5 of Regulation (EU) 2015/479, for a period of six weeks. Hereafter, on 12 March 2021, the Commission adopted Implementing Regulation (EU) 2021/442 (3) making the exportation of the same products subject to an export authorisation until 30 June 2021, pursuant to Article 6 of Regulation (EU) 2015/479.

| (2) | On 24 March 2021, the Commission adopted Implementing Regulation (EU) 2021/521 (4) introducing as an additional factor when considering granting an export authorisation, the need to assess whether such authorisation does not pose a threat to the security of supply within the Union of the goods covered by Regulation (EU) 2021/442. By the same Regulation, the Commission decided on a temporary suspension of the exemption of certain destination countries from the scope of Regulation (EU) 2021/442. |
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(2)

On 24 March 2021, the Commission adopted Implementing Regulation (EU) 2021/521 (4) introducing as an additional factor when considering granting an export authorisation, the need to assess whether such authorisation does not pose a threat to the security of supply within the Union of the goods covered by Regulation (EU) 2021/442. By the same Regulation, the Commission decided on a temporary suspension of the exemption of certain destination countries from the scope of Regulation (EU) 2021/442.

| (3) | Commission Implementing Regulation (EU) 2021/521 was adopted pursuant to Article 5 of Regulation (EU) 2015/479 and applied for a period of six weeks. The measures introduced by that Regulation were subsequently extended until 30 June 2021 by Commission Implementing Regulation (EU) 2021/734 (5) and until 30 September 2021 by Commission Implementing Regulation (EU) 2021/1071 (6). |
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(3)

Commission Implementing Regulation (EU) 2021/521 was adopted pursuant to Article 5 of Regulation (EU) 2015/479 and applied for a period of six weeks. The measures introduced by that Regulation were subsequently extended until 30 June 2021 by Commission Implementing Regulation (EU) 2021/734 (5) and until 30 September 2021 by Commission Implementing Regulation (EU) 2021/1071 (6).

| (4) | Deliveries of COVID-19 vaccine doses in the Union have been continuing, resulting in a clear progress of the vaccination campaign in the Union. |
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(4)

Deliveries of COVID-19 vaccine doses in the Union have been continuing, resulting in a clear progress of the vaccination campaign in the Union.

| (5) | This vaccination campaign is however still ongoing and uncertainties remain, in particular with the emergence of new variants of the COVID-19 virus. There is therefore a continuing need for transparency of export deliveries and Union supplies. |
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(5)

This vaccination campaign is however still ongoing and uncertainties remain, in particular with the emergence of new variants of the COVID-19 virus. There is therefore a continuing need for transparency of export deliveries and Union supplies.

| (6) | The risk that exports would threaten either the execution of the Advance Purchase Agreements between the Union and the vaccine manufacturers or the security of Union supplies of COVID-19 vaccines and their active substances also still persists. |
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(6)

The risk that exports would threaten either the execution of the Advance Purchase Agreements between the Union and the vaccine manufacturers or the security of Union supplies of COVID-19 vaccines and their active substances also still persists.

| (7) | Measures introduced by Implementing Regulation (EU) 2021/442 and Implementing Regulation (EU) 2021/521 should therefore continue to apply until 31 December 2021. Those Regulations should therefore be amended accordingly. |
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(7)

Measures introduced by Implementing Regulation (EU) 2021/442 and Implementing Regulation (EU) 2021/521 should therefore continue to apply until 31 December 2021. Those Regulations should therefore be amended accordingly.

| (8) | The Appeal Committee was consulted on this Regulation. The appeal committee did not deliver an opinion, |
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(8)

The Appeal Committee was consulted on this Regulation. The appeal committee did not deliver an opinion,

HAS ADOPTED THIS REGULATION:

Article 1

In Article 4 of Implementing Regulation (EU) 2021/442, the second paragraph is replaced by the following:

‘It shall apply until 31 December 2021.’.

Article 2

In Article 3 of Implementing Regulation (EU) 2021/521, the second paragraph is replaced by the following:

‘It shall apply until 31 December 2021.’.

Article 3

This Regulation shall enter into force on 1 October 2021.

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

Done at Brussels, 29 September 2021.

For the Commission

The President

Ursula VON DER LEYEN

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(1)  
  OJ L 83, 27.3.2015, p. 34.

1

(2)  
  OJ L 31 I, 30.1.2021, p. 1.

2

(3)  
  OJ L 85, 12.3.2021, p. 190.

3

(4)  
  OJ L 104, 25.3.2021, p. 52.

4

(5)  
  OJ L 158, 6.5.2021, p. 13.

5

(6)  
  OJ L 230, 30.6.2021, p. 28.

6

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