Commission Implementing Regulation (EU) 2021/2071

Contents

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^note, and in particular Article 4 thereof,Whereas:

(1)On 30 January 2021, the Commission adopted Implementing Regulation (EU) 2021/111^note 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^note 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^note 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^note.

(4)Both Regulation (EU) 2021/442 and Regulation (EU) 2021/521 were further extended, first until 30 September 2021 by Commission Implementing Regulation (EU) 2021/1071^note, and then until 31 December 2021 by Commission Implementing Regulation (EU) 2021/1728^note.

(5)The production and deliveries of COVID-19 vaccine doses in the Union have been accelerated and the risk that exports would threaten 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 have currently reduced.

(6)Under the current circumstances and situation of supply, the Commission considered the application of the requirement to produce an export authorisation for the exports of vaccines against SARS-related coronaviruses (SARS-CoV species) and active substances, including master and working cell banks used for the manufacture of such vaccines, after 31 December 2021, not required.

(7)However, it remains necessary to subject to surveillance using the procedure based on Article 56(5) of Regulation (EU) No 952/2013 of the European Parliament and of the Council^note, and to require that the export or re-export declaration includes the TARIC additional codes, provided in the Annex, as well as the numbers of doses (in case of multi-dose containers, dose for adults) for a period of 24 months as from 1 January 2022.

(8)This surveillance should allow the Commission to collect supplementary statistical export data at the level of each manufacturer with a view to detecting in a timely manner (i) any indication of lack of compliance with the Advance Purchase Agreement concluded by the Commission (ii) any other circumstance that could threaten the Union’s security of supply, and (iii) the Union’s capacity to pledge, and deliver, further donations. This should enable the Commission, where warranted, to take further action in order to prevent a critical situation from arising on account of a shortage of these products in accordance with the requirements of Regulation (EU) 2015/479,

HAS ADOPTED THIS REGULATION: