Date: 2021-09-30Category: Not ApplicableState: Union GovernmentCountry: Europe
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
Issued by European Commission
· Directorate-General for Trade and Economic Security
Executive Summary:
Commission Implementing Regulation (EU) 2021/1728 amends Implementing Regulations (EU) 2021/442 and (EU) 2021/521, extending the export authorization mechanism for certain products, specifically COVID-19 vaccines and related active substances. This extension is due to the ongoing vaccination campaign, the emergence of new variants, and the continuing need for transparency and security of supply within the Union. The regulations now apply until December 31, 2021, and enter into force on October 1, 2021.
Key Points / Main Content:
Extension of Export Authorisation Mechanism:
* Implementing Regulation (EU) 2021/1728 extends the application of export authorisation requirements for COVID-19 vaccines and related substances.
* The extension addresses the ongoing need for transparency and security of vaccine supplies within the Union due to continued vaccination efforts and emerging virus variants.
Amendments to Existing Regulations:
* Article 1 amends Article 4 of Implementing Regulation (EU) 2021/442, replacing the original end date with "31 December 2021".
* Article 2 amends Article 3 of Implementing Regulation (EU) 2021/521, replacing the original end date with "31 December 2021".
Effective Date:
* The regulation enters into force on October 1, 2021.
* The measures introduced by Implementing Regulation (EU) 2021/442 and Implementing Regulation (EU) 2021/521 now apply until December 31, 2021.
Impact Analysis:
European Union (EU):
Impact: Ensures continued transparency and security of COVID-19 vaccine supplies within the Union, supporting the ongoing vaccination campaign and addressing the risks posed by new variants.
Action Required: Ensure compliance with the extended export authorisation requirements for COVID-19 vaccines and related substances until December 31, 2021.
Vaccine Manufacturers:
Impact: Continued requirement to obtain export authorisations for COVID-19 vaccines and related active substances.
Action Required: Continue to apply for and obtain export authorisations for products covered by the amended regulations until December 31, 2021.
Member States:
Impact: Continued application of the export authorisation mechanism within their jurisdiction.
Action Required: Enforce the extended export authorisation requirements for COVID-19 vaccines and related substances until December 31, 2021.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: The executive branch of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation EU 2015/479: Regulation of the European Parliament and of the Council on common rules for exports.
Implementing Regulation EU 2021/442: Commission Implementing Regulation making certain products subject to the production of an export authorisation.
Implementing Regulation EU 2021/521: Commission Implementing Regulation introducing an additional factor when considering granting an export authorisation.
COVID-19: An infectious disease caused by the SARS-CoV-2 virus.
Advance Purchase Agreements: Agreements between the Union and the vaccine manufacturers.
Brussels: City in Belgium, where the regulation was adopted.
L 345/34 EN Official Journal of the European Union 30.9.2021
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 2015on 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.
(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 2021by Commission Implementing Regulation (EU) 2021/734(5)and until 30 September
2021by 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.
(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.
(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,
(1) OJ L 83, 27.3.2015, p. 34.
(2) OJ L 31 I, 30.1.2021, p. 1.
(3) OJ L 85, 12.3.2021, p. 190.
(4) OJ L 104, 25.3.2021, p. 52.
(5) OJ L 158, 6.5.2021, p. 13.
(6) OJ L 230, 30.6.2021, p. 28.30.9.2021 EN Official Journal of the European Union L 345/35
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