Article 46 GDPR

← Article 46 - Transfers subject to appropriate safeguards →
Chapter 1: General provisions Article 1: Subject-matter and objectives Article 2: Material scope Article 3: Territorial scope Article 4: Definitions Chapter 2: Principles Article 5: Principles relating to processing of personal data Article 6: Lawfulness of processing Article 7: Conditions for consent Article 8: Conditions applicable to child’s consent in relation to information society services Article 9: Processing of special categories of personal data Article 10: Processing of personal data relating to criminal convictions and offences Article 11: Processing which does not require identification Chapter 3: Rights of the data subject Article 12: Transparent information, communication and modalities for the exercise of the rights of the data subject Article 13: Information to be provided where personal data are collected from the data subject Article 14: Information to be provided where personal data have not been obtained from the data subject Article 15: Right of access by the data subject Article 16: Right to rectification Article 17: Right to erasure (‘right to be forgotten’) Article 18: Right to restriction of processing Article 19: Notification obligation regarding rectification or erasure of personal data or restriction of processing Article 20: Right to data portability Article 21: Right to object Article 22: Automated individual decision-making, including profiling Article 23: Restrictions Chapter 4: Controller and processor Article 24: Responsibility of the controller Article 25: Data protection by design and by default Article 26: Joint controllers Article 27: Representatives of controllers or processors not established in the Union Article 28: Processor Article 29: Processing under the authority of the controller or processor Article 30: Records of processing activities Article 31: Cooperation with the supervisory authority Article 32: Security of processing Article 33: Notification of a personal data breach to the supervisory authority Article 34: Communication of a personal data breach to the data subject Article 35: Data protection impact assessment Article 36: Prior consultation Article 37: Designation of the data protection officer Article 38: Position of the data protection officer Article 39: Tasks of the data protection officer Article 40: Codes of conduct Article 41: Monitoring of approved codes of conduct Article 42: Certification Article 43: Certification bodies Chapter 5: Transfers of personal data Article 44: General principle for transfers Article 45: Transfers on the basis of an adequacy decision Article 46: Transfers subject to appropriate safeguards Article 47: Binding corporate rules Article 48: Transfers or disclosures not authorised by Union law Article 49: Derogations for specific situations Article 50: International cooperation for the protection of personal data Chapter 6: Supervisory authorities Article 51: Supervisory authority Article 52: Independence Article 53: General conditions for the members of the supervisory authority Article 54: Rules on the establishment of the supervisory authority Article 55: Competence Article 56: Competence of the lead supervisory authority Article 57: Tasks Article 58: Powers Article 59: Activity reports Chapter 7: Cooperation and consistency Article 60: Cooperation between the lead supervisory authority and the other supervisory authorities concerned Article 61: Mutual assistance Article 62: Joint operations of supervisory authorities Article 63: Consistency mechanism Article 64: Opinion of the Board Article 65: Dispute resolution by the Board Article 66: Urgency procedure Article 67: Exchange of information Article 68: European Data Protection Board Article 69: Independence Article 70: Tasks of the Board Article 71: Reports Article 72: Procedure Article 73: Chair Article 74: Tasks of the Chair Article 75: Secretariat Article 76: Confidentiality Chapter 8: Remedies, liability and penalties Article 77: Right to lodge a complaint with a supervisory authority Article 78: Right to an effective judicial remedy against a supervisory authority Article 79: Right to an effective judicial remedy against a controller or processor Article 80: Representation of data subjects Article 81: Suspension of proceedings Article 82: Right to compensation and liability Article 83: General conditions for imposing administrative fines Article 84: Penalties Chapter 9: Specific processing situations Article 85: Processing and freedom of expression and information Article 86: Processing and public access to official documents Article 87: Processing of the national identification number Article 88: Processing in the context of employment Article 89: Safeguards and derogations relating to processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes Article 90: Obligations of secrecy Article 91: Existing data protection rules of churches and religious associations Chapter 10: Delegated and implementing acts Article 92: Exercise of the delegation Article 93: Committee procedure Chapter 11: Final provisions Article 94: Repeal of Directive 95: /46: /EC Article 95: Relationship with Directive 20: 02: /58: /EC Article 96: Relationship with previously concluded Agreements Article 97: Commission reports Article 98: Review of other Union legal acts on data protection Article 99: Entry into force and application

Legal Text

Article 46 - Transfers subject to appropriate safeguards

1. In the absence of a decision pursuant to Article 45(3), a controller or processor may transfer personal data to a third country or an international organisation only if the controller or processor has provided appropriate safeguards, and on condition that enforceable data subject rights and effective legal remedies for data subjects are available.

2. The appropriate safeguards referred to in paragraph 1 may be provided for, without requiring any specific authorisation from a supervisory authority, by:

(a) a legally binding and enforceable instrument between public authorities or bodies;

(b) binding corporate rules in accordance with Article 47;

(c) standard data protection clauses adopted by the Commission in accordance with the examination procedure referred to in Article 93(2);

(d) standard data protection clauses adopted by a supervisory authority and approved by the Commission pursuant to the examination procedure referred to in Article 93(2);

(e) an approved code of conduct pursuant to Article 40 together with binding and enforceable commitments of the controller or processor in the third country to apply the appropriate safeguards, including as regards data subjects' rights; or

(f) an approved certification mechanism pursuant to Article 42 together with binding and enforceable commitments of the controller or processor in the third country to apply the appropriate safeguards, including as regards data subjects' rights.

3. Subject to the authorisation from the competent supervisory authority, the appropriate safeguards referred to in paragraph 1 may also be provided for, in particular, by:

(a) contractual clauses between the controller or processor and the controller, processor or the recipient of the personal data in the third country or international organisation; or

(b) provisions to be inserted into administrative arrangements between public authorities or bodies which include enforceable and effective data subject rights.

4. The supervisory authority shall apply the consistency mechanism referred to in Article 63 in the cases referred to in paragraph 3 of this Article.

5. Authorisations by a Member State or supervisory authority on the basis of Article 26(2) of Directive 95/46/EC shall remain valid until amended, replaced or repealed, if necessary, by that supervisory authority. Decisions adopted by the Commission on the basis of Article 26(4) of Directive 95/46/EC shall remain in force until amended, replaced or repealed, if necessary, by a Commission Decision adopted in accordance with paragraph 2 of this Article.

Relevant Recitals

Recital 108: Transfers Subject to Appropriate Safeguards

In the absence of an adequacy decision, the controller or processor should take measures to compensate for the lack of data protection in a third country by way of appropriate safeguards for the data subject. Such appropriate safeguards may consist of making use of binding corporate rules, standard data protection clauses adopted by the Commission, standard data protection clauses adopted by a supervisory authority or contractual clauses authorised by a supervisory authority. Those safeguards should ensure compliance with data protection requirements and the rights of the data subjects appropriate to processing within the Union, including the availability of enforceable data subject rights and of effective legal remedies, including to obtain effective administrative or judicial redress and to claim compensation, in the Union or in a third country. They should relate in particular to compliance with the general principles relating to personal data processing, the principles of data protection by design and by default. Transfers may also be carried out by public authorities or bodies with public authorities or bodies in third countries or with international organisations with corresponding duties or functions, including on the basis of provisions to be inserted into administrative arrangements, such as a memorandum of understanding, providing for enforceable and effective rights for data subjects. Authorisation by the competent supervisory authority should be obtained when the safeguards are provided for in administrative arrangements that are not legally binding.

Recital 109: Standard Data-Protection Clauses

The possibility for the controller or processor to use standard data-protection clauses adopted by the Commission or by a supervisory authority should prevent controllers or processors neither from including the standard data-protection clauses in a wider contract, such as a contract between the processor and another processor, nor from adding other clauses or additional safeguards provided that they do not contradict, directly or indirectly, the standard contractual clauses adopted by the Commission or by a supervisory authority or prejudice the fundamental rights or freedoms of the data subjects. Controllers and processors should be encouraged to provide additional safeguards via contractual commitments that supplement standard protection clauses.

Commentary

Article 46(1) allows the transfer of personal data to a third country or an international organisation in the absence of an adequacy decision and always 'on condition that enforceable data subject rights and effective legal remedies for data subjects are available'. This provision, together with the others contained in Chapter V, thus contributes to the transfer of personal data in a globalised economy while ensuring a level of protection comparable to that provided by European law. From a practical point of view, the instruments regulated by Article 46 are very important, since the vast majority of third countries or international organisations do not have their own adequacy decision under Article 45 GDPR. Therefore, in the absence of such instruments, data transfer would be precluded to a large part of the planet.

(1) Scope

Article 46(1) allows the transfer of personal data to a third country or an international organisation in the absence of an adequacy decision, by means of appropriate safeguards. Although the provision seems to limit its scope to cases where there is no adequacy decision, it should be pointed out that the safeguards mentioned in the provision constitute an alternative system of data transfer and can therefore be additional elements to the adequacy decision. For example, there may be cases where the controller, for a variety of reasons, may consider that the adequacy decision is invalid, or does not provide an essentially equivalent level of protection. In such circumstances, it would not make sense to inhibit the controller from using these additional tools to increase the protection of data subject rights.

Appropriate Safeguards

According to Recital 108, appropriate safeguards may consist of making use of binding corporate rules, standard data protection clauses (also known as standard contractual clauses or SCCs) adopted by the European Commission (Commission), standard data protection clauses adopted by a data protection authority (DPA) or contractual clauses authorised by a DPA. Those safeguards should ensure compliance with data protection requirements and the rights of the data subjects appropriate to processing within the Union.This includes the availability of enforceable data subject rights and of effective legal remedies, the possibility to obtain effective administrative or judicial redress, as well as to claim compensation, in the Union or in a third country.

Enforceable Data Subject Rights

Paragraph 1 clarifies that a transfer on the basis of appropriate safeguards may only take place if enforceable rights are granted to the data subject. This includes, in particular, the right of access (Article 15 GDPR), rectification (Article 16 GDPR), deletion (Article 17 GDPR), restriction of processing (Article 18 GDPR), objection (Article 21 GDPR) and the right to ‘claim damages’ in the EU or in a third country. However, the mere granting of substantive rights is of little use to the data subject; in order to enforce them, the data subject must also have effective remedies at their disposal. The absence of an adequacy decision entails that there are no legal provisions on which the data subject can rely on if they wish to enforce their rights. Therefore, a different legal avenue is required. This can only be based on a voluntary commitment of the data processing body in the third country, which can be expressed in a construction such as a civil law contract for the benefit of third parties, which in this case would be the data subjects.

Effective Legal Remedies

A further condition for the application of the safeguards in question is that the data subject must have effective legal remedies against possible infringements in the third country. This requirement clearly consists in the possibility of taking legal action in the third country. The practical feasibility of this requirement is however controversial. In many cases, the ordinary consumer will be faced with complex legal wrangling in distant and unfamiliar legal systems, including potential costs. For these reasons, some have branded this requirement as an "empty promise".

All the Above post Schrems II

In Schrems II, the CJEU held that the notions of appropriate safeguards, enforceable rights, and effective legal remedies under Article 46 GDPR must be interpreted in light of Article 44 GDPR, which states that “all provisions [in Chapter V, including Article 46 GDPR and its SCCs] shall be applied in order to ensure that the level of protection of natural persons guaranteed by [the GDPR] is not undermined”. The Court continued: “that level of protection must therefore be guaranteed irrespective of the provision of that chapter on the basis of which a transfer of personal data to a third country is carried out”. In particular, in the absence of an adequacy decision, and with specific regard to the SCCs, the data exporter should determine whether the laws of the data importer’s country provide an “essentially equivalent” protection of personal data to that guaranteed under EU law. Should that not be the case, “supplementary measures” must be implemented and, if such measures would still not provide an “essentially equivalent” protection, the data transfer must then be suspended.

The EDPB has provided specific guidance on the matter. In practice, the data exporter must always check whether the legal situation in the recipient country enables the data importer to comply with the contractual obligations entered into – for example in the form of standard data protection clauses – such as those to process the received data exclusively in accordance with the exporter's instructions. As a consequence, the exporter must verify the state of law and practice in the third country. The analysis should not cover the entire legal system of the third country, but should rather be limited to the most critical areas including law enforcement, intelligence services and specific sectoral disciplines relevant to the specific processing activity. Once the relevant laws have been identified, the third-country law’s compliance with the essential elements of clarity and predictability should then be verified. Finally, an assessment should be made as to whether the law meets the criterion of strict necessity in a democratic society to ensure, among others, state security, national defence or public safety. The mere absence of either of such requirements should lead to the blocking of transfers to the third country unless “additional safeguards” are available to protect the transferred personal data. The EDPB, in its Recommendations 1/2020 paper, mentions mostly encryption and pseudonymisation. However, in some transmission scenarios, it will not be possible to find additional measures that are effective and thus could still "save" the transmission.

The CJEU has hereby imposed a considerable burden on data exporters who wish to transfer personal data to any third country. They must actively deal with the legal situation in the third country on an ongoing basis. From this point of view, the Schrems II ruling may indicate a certain trend towards the establishment of EU-based servers and storage space.

(2) Appropriate Safeguards

Article 46(2) GDPR provides a list of appropriate safeguards that the controller or processor may use to transfer data without a prior authorisation from the DPA. The list includes the following transfer instruments (or safeguards): (a) a legally binding and enforceable instruments between public authorities or bodies; (b) binding corporate rules in accordance with Article 47 GDPR; (c) standard data protection clauses adopted by the Commission; (d) standard data protection clauses adopted by a DPA and subsequently approved by the Commission; (e) an approved code of conduct; or (f) an approved certification mechanism.

(a) Legally binding and enforceable instrument between public authorities or bodies

A “legally binding and enforceable instrument between public authorities or bodies” allows data transfers between such entities. This could include, for example, an international agreement (i.e. a treaty) to share data between an EU-based public authority and one in a third country. The provision does not clarify what is meant by an instrument. Recital 108, however, reduces the uncertainty by mentioning “administrative arrangements, such as a memorandum of understanding, providing for enforceable and effective rights for data subjects”.

EDPB Guidelines: on this provision there are Guidelines 2/2020 on articles 46 (2) (a) and 46 (3) (b) of Regulation 2016/679 for transfers of personal data between EEA and non-EEA public authorities and bodies

(b) Binding corporate rules in accordance with Article 47

Binding corporate rules allow the transfer of personal data to third countries without an adequacy decision, when the transfer takes place within the same group of companies. For more on this, please refer to the commentary on Article 47 GDPR.

(c) Standard data protection clauses adopted by the Commission under Article 93(2)

Standard data protection clauses (or SCCs), are a set of predefined clauses prepared by the European Commission and adopted under through a decision under Article 93(2) GDPR. A first set of such clauses were established by decisions 2001/497/EC and 2010/87/EU. As mentioned above, with the Schrems II decision, the CJEU emphasised that not only adequacy decisions (Article 45 GDPR), but also SCCs, must ensure an essentially equivalent level of protection and that it is incumbent on the controller to ensure that additional safeguards are given where the case so requires.

Taking this into account, on 4 June 2021 the Commission adopted the Implementing Decision (EU) 2021/914, which established a new set of SCCs. These clauses transpose the main aspects of the GDPR as well as the Schrems II ruling into contractual terms. Among other things, by signing the SCCs, the contractual parties are required to, among the others, (i) fully inform the data subjects about the processing and the transfer, (ii) ensure the full exercise of their GDPR rights; (iii) provide an easy point of contact for the data subject to make any complaints or claims; (iv) continuously assess the importer’s national law and verify whether it provides an essentially equivalent level of protection and, should that not be the case, (v) adopt additional measures to solve the problem or otherwise interrupt the transfer. Moreover, (vi) data subjects should be able to be represented in court by non-profit associations, and to claim compensation for damages resulting from unlawful processing operations.

Recital 109 GDPR clarifies that there is no prohibition against "adding other clauses or additional safeguards provided that they do not contradict, directly or indirectly, the standard contractual clauses adopted by the Commission or by a supervisory authority or prejudice the fundamental rights or freedoms of the data subjects". However, any amendment of the "standard clauses means that they will be considered to be ad hoc clauses that require the authorisation of the competent DPA" under Article 46(3)(a) GDPR.Article 46(1) allows the transfer of personal data to a third country or an international organisation in the absence of an adequacy decision and always 'on condition that enforceable data subject rights and effective legal remedies for data subjects are available'. This provision, together with the others contained in Chapter V, thus contributes to the transfer of personal data in a globalised economy while ensuring a level of protection comparable to that provided by European law. From a practical point of view, the instruments regulated by Article 46 are very important, since the vast majority of third countries or international organisations do not have their own adequacy decision under

(d) Standard data protection clauses adopted by a supervisory authority and approved by the Commission

A further innovation of the GDPR is the possibility for SCCs to be adopted not only by the Commission, but also by the DPAs of the individual Member States. The adoption of such clauses requires, firstly, the mandatory opinion of the EDPB under Article 64(1)(d) GDPR and, subsequently, the acceptance of the Commission under the procedure provided for in Article 93(2) GDPR.

(e) Approved code of conduct pursuant to Article 40

Codes of conduct are another novelty brought by the GDPR. They are drawn up by associations (which may represent certain groups of data processors) and provide these bodies with guidelines for the application of the GDPR, for example, with regard to technical and organisational security measures, reporting obligations in the event of data protection violations, as well as data transfers to third countries or to international organisations. For further information, please refer to the commentary on Article 40 GDPR.

EDPB Guidelines: For this provision, please see Guidelines 04/2021 on Codes of Conduct as tools for transfers

(f) Approved certification mechanism pursuant to Article 42

The GDPR does not contain a definition of "certification mechanism" although Article 42 GDPR refers to "data protection seals and marks". An example of a certification mechanism would thus "presumably be a trustmark placed on a website, which would have to be backed up by some sort of code of conduct or code of practice". Certification mechanisms are voluntary, but under Article 42(5) GDPR they may be approved either by a DPA or a national certification body as set out in Article 43 GDPR. A certification mechanism must contain "binding and enforceable commitments of the controller or processor in the third country to apply the appropriate safeguards", and must thus be legally binding. No additional DPA authorisation is required for the use of a certification mechanism once it has been approved.

EDPB Guidelines: on this provision, please see Guidelines 07/2022 on certification as a tool for transfers

(3) Other Safeguards which require an Authorization by the DPA

In addition to the appropriate safeguards provided for in paragraph 2, paragraph 3 opens to further hypotheses. In this case, though, the use of such safeguards require the SA's prior authorisation. The provision mentions two examples, (a) contractual clauses between the controller or processor and the controller, processor or the recipient ("Ad-hoc Contractual Clauses") and (b) provisions to be inserted into administrative arrangements between public authorities ("Administrative Arrangements").

(a) Ad-hoc Contractual Clauses

Article 46(3)(a) GDPR allows the creation of specific transfer agreements between exporter and importer. It is clear that the contract should clarify the essential aspects of the transfer and follow the SCC’s structure in terms of content and safeguards. For example, clauses defining the intended purpose, the categories of data to be transmitted or the measures to prevent unauthorized access. In contrast to the subsequent Article 46(3)(b), this provision does not provide that the clauses must include "enforceable and effective data subject rights". This is evidently a drafting error since it is precisely in such cases that there is a need to protect the interests of the data subject. Consequently, the ad-hoc clauses should also contain provisions on such safeguards.

(b) Administrative Arrangements

Article 46(3)(b) GDPR permits transfers based on "provisions to be inserted into administrative arrangements between public authorities or bodies". Unlike the agreements referred to in Article 46(2)(a) above, these agreements are not "legally binding" (Recital 108 speaks of "memorandum of understandings"), which is why they require prior authorisation by the DPA. Kuner correctly points out that it is unclear "how 'enforceable and effective' rights for data subjects can be provided when the arrangements under which such rights are to be secured are themselves not legally binding".

EDPB Guidelines: on this provision there are Guidelines 2/2020 on articles 46 (2) (a) and 46 (3) (b) of Regulation 2016/679 for transfers of personal data between EEA and non-EEA public authorities and bodies

(4) Consistency Mechanism in case Paragraph 3 Applies

The appropriate safeguards under paragraph 3 must be submitted to the respective DPAfor examination and approval. The supervisory authorities must not only provide an express answer, but also needs to be proactive and assess the effectiveness of the proposed safeguards. The DPA shall also apply the consistency mechanism referred to in Article 63 GDPR.

(5) Continuous Validity

Authorisations by a Member State or a DPAon the basis of Article 26(2) DPD shall remain valid until amended, replaced or repealed, if necessary, by that DPA. Similarly, decisions adopted by the Commission on the basis of Article 26(4) DPD shall remain in force until amended, replaced or repealed, if necessary, by a Commission Decision adopted in accordance with paragraph 2 of the aforementioned DPD provision.

Decisions

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