Standard contractual clauses (SCC)

Standard contractual clauses (SCCs) are model data protection clauses adopted by the European Commission under Art. 46(2)(c) GDPR which, when incorporated without modification into a contract between a data exporter subject to the GDPR and a data importer in a third country, provide appropriate safeguards for the international transfer of personal data. The current set, adopted by Implementing Decision (EU) 2021/914, replaced the 2001, 2004 and 2010 clauses, which could no longer be used after 27 December 2022.

The 2021 SCCs use a modular structure: Module 1 controller to controller, Module 2 controller to processor, Module 3 processor to processor, and Module 4 processor to controller. The parties select the module, complete Annex I (parties and description of the transfer), Annex II (technical and organisational measures) and Annex III (sub-processors), and may add a docking clause, an optional redress clause and the choice of governing law and forum within the EU. Modules 2 and 3 also satisfy the Art. 28 requirements, so a separate DPA is not strictly needed for the transfer relationship. Clause 14 obliges the parties to carry out and document a transfer impact assessment of the importer's local laws, and Clause 15 governs responses to government access requests, both codifying the Schrems II requirements; where the assessment reveals a risk, supplementary measures are needed.

The SCCs cannot be used where the importer is itself directly subject to the GDPR under Art. 3(2); the Commission has announced a dedicated set of clauses for that case. The UK uses its own International Data Transfer Agreement or the UK Addendum to the EU SCCs, and Switzerland requires specific adaptations of the EU SCCs recognised by the FDPIC. In clinical research, SCCs are concluded between EU sponsors or sites and non-EU sponsors, CROs, central laboratories and technology vendors; they do not cover disclosures to non-EU regulators such as the FDA, which rely on Art. 49(1)(d). iliomad reviews and completes SCCs as part of its contractual review services.