
Article 1 
This Regulation lays down the criteria for the  making and consideration of applications referred to in  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  United Kingdom  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 the Secretary of State....
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  Secretary of State  may request additional evidence from the applicants, which shall provide it within a reasonable period set by the Secretary of State.
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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  Secretary of State  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 ... country which is at the origin of the listed extra-territorial legislation;
((c)) the existence of a substantial connecting link with the ... 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 ... 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  United Kingdom’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  United Kingdom  and the impact of any shortage or disruption therein;
((k)) the consequences for the financial or economic stability of the United Kingdom or key United Kingdom infrastructure;
((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  the United Kingdom;
((n)) any other relevant factor.
Article 5 
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Article 6 

1. The  Secretary of State  shall process personal data in order to carry out ... tasks under this Regulation.
2. Any processing of personal data shall comply with Regulation (EU) 2016/679 ....
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Article 7 
This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.
...Done at Brussels, 3 August 2018.
For the Commission
The President
Jean-Claude JUNCKER