
Article 1 
This Regulation lays down the criteria for the application of the second paragraph of Article 5 of Regulation (EC) No 2271/96.
Article 2 
For the purposes of this Regulation, the following definitions apply:

((a)) ‘listed extra-territorial legislation’ means the laws, regulations and other legislative instruments specified in the Annex to Regulation (EC) No 2271/96, including regulations and other legislative instruments based thereon or resulting therefrom;
((b)) ‘subsequent actions’ means actions based on the listed extra-territorial legislation or resulting therefrom;
((c)) ‘non-compliance’ means non-compliance by direct actions or deliberate omissions with requirements or prohibitions, including requests of foreign courts, based on or resulting, directly or indirectly, from the listed extra-territorial legislation or subsequent actions;
((d)) ‘protected interests’ means the interest of any person referred to in Article 11 of Regulation (EC) No 2271/96, the interest of the Union or both;
((e)) ‘applicant’ means any person referred to in Article 11 of Regulation (EC) No 2271/96 who applied for an authorisation referred to in the second paragraph of Article 5 of Regulation (EC) No 2271/96.
Article 3 

1. Applications for an authorisation referred to in the second paragraph of Article 5 of Regulation (EC) No 2271/96 shall be submitted in writing to:European CommissionService for Foreign Policy InstrumentsEEAS 07/99B-1049 Brussels, BelgiumEC-AUTHORISATIONS-BLOCKING-REG@ec.europa.eu
2. Applications shall include the name and contact details of the applicants, shall indicate the precise provisions of the listed extra-territorial legislation or the subsequent action at stake, and shall describe the scope of the authorisation that is being requested and the damage that would be caused by non-compliance.
3. The applicants shall provide in their application sufficient evidence that non-compliance would cause serious damage to at least one protected interest.
4. Where necessary, the Commission may request additional evidence from the applicants, which shall provide it within a reasonable period set by the Commission.
5. The Commission shall inform the Committee on Extra-territorial Legislation as soon as it receives applications.
Article 4 
When assessing whether a serious damage to the protected interests as referred to in the second paragraph of Article 5 of Regulation (EC) No 2271/96 would arise, the Commission shall consider, inter alia, the following non-cumulative criteria, where appropriate:

((a)) whether the protected interest is likely to be specifically at risk, based on the context, the nature and the origin of a damage to the protected interest;
((b)) the existence of an ongoing administrative or judicial investigation against the applicant from, or a prior settlement agreement with, the third country which is at the origin of the listed extra-territorial legislation;
((c)) the existence of a substantial connecting link with the third country which is at the origin of the listed extraterritorial legislation or the subsequent actions; for example the applicant has parent companies or subsidiaries, or participation of natural or legal persons subject to the primary jurisdiction of the third country which is at the origin of the listed extra-territorial legislation or the subsequent actions;
((d)) whether measures could be reasonably taken by the applicant to avoid or mitigate the damage;
((e)) the adverse effect on the conduct of economic activity, in particular whether the applicant would face significant economic losses, which could for example threaten its viability or pose a serious risk of bankruptcy;
((f)) whether the applicant's activity would be rendered excessively difficult due to a loss of essential inputs or resources, which cannot be reasonably replaced;
((g)) whether the enjoyment of the individual rights of the applicant would be significantly hindered;
((h)) whether there is a threat to safety, security, the protection of human life and health and the protection of the environment;
((i)) whether there is a threat to the Union's ability to carry out its humanitarian, development and trade policies or the external aspects of its internal policies;
((j)) the security of supply of strategic goods or services within or to the Union or a Member State and the impact of any shortage or disruption therein;
((k)) the consequences for the internal market in terms of free movement of goods, persons, services and capital, as well as financial and economic stability or key Union infrastructures;
((l)) the systemic implications of the damage, in particular as regards its spill over effects into other sectors;
((m)) the impact on the employment market of one or several Member States and its cross-border consequences within the Union;
((n)) any other relevant factor.
Article 5 

1. When, after completing the assessment referred to in Article 4, the Commission finds sufficient evidence that non-compliance would cause serious damage to the protected interests, the Commission shall expeditiously submit to the Committee on Extra-territorial Legislation a draft decision containing the appropriate measures to be taken.
2. If, after completing the assessment referred to in Article 4, the Commission does not find sufficient evidence that non-compliance would cause serious damage to the protected interests, the Commission shall submit to the Committee on Extra-territorial Legislation a draft decision rejecting the application.
3. The final decision shall be notified by the Commission to the applicant without delay.
Article 6 

1. The Commission shall process personal data in order to carry out its tasks under this Regulation.
2. Any processing of personal data shall comply with Regulation (EU) 2016/679 and Regulation (EC) No 45/2001.
3. For the purposes of this Regulation, the Service for Foreign Policy Instruments is designated as ‘controller’ for the Commission within the meaning of Article 2(d) of Regulation (EC) No 45/2001, in order to ensure that the natural persons concerned can exercise their rights under that Regulation.
Article 7 
This Regulation shall enter into force on the day 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, 3 August 2018.
For the Commission
The President
Jean-Claude JUNCKER