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GDPR Art. 35 EN
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Data protection impact assessment

In force — consolidated2016-05-04 · CELEX 02016R0679-20160504 · ELI ↗
Version history 2
  • 2016-05-04in force CELEX 02016R0679-20160504
  • 2016-04-27 CELEX 32016R0679
  1. 1.

    Where a type of processing in particular using new technologies, and taking into account the nature, scope, context and purposes of the processing, is likely to result in a high risk to the rights and freedoms of natural persons, the controller shall, prior to the processing, carry out an assessment of the impact of the envisaged processing operations on the protection of personal data. A single assessment may address a set of similar processing operations that present similar high risks.

  2. 2.

    The controller shall seek the advice of the data protection officer, where designated, when carrying out a data protection impact assessment.

  3. 3.

    A data protection impact assessment referred to in paragraph 1 shall in particular be required in the case of:

    1. a)
      a systematic and extensive evaluation of personal aspects relating to natural persons which is based on automated processing, including profiling, and on which decisions are based that produce legal effects concerning the natural person or similarly significantly affect the natural person;
    2. b)
      processing on a large scale of special categories of data referred to in Article 9(1), or of personal data relating to criminal convictions and offences referred to in Article 10; or
    3. c)
      a systematic monitoring of a publicly accessible area on a large scale.
  4. 4.

    The supervisory authority shall establish and make public a list of the kind of processing operations which are subject to the requirement for a data protection impact assessment pursuant to paragraph 1. The supervisory authority shall communicate those lists to the Board referred to in Article 68.

  5. 5.

    The supervisory authority may also establish and make public a list of the kind of processing operations for which no data protection impact assessment is required. The supervisory authority shall communicate those lists to the Board.

  6. 6.

    Prior to the adoption of the lists referred to in paragraphs 4 and 5, the competent supervisory authority shall apply the consistency mechanism referred to in Article 63 where such lists involve processing activities which are related to the offering of goods or services to data subjects or to the monitoring of their behaviour in several Member States, or may substantially affect the free movement of personal data within the Union.

  7. 7.

    The assessment shall contain at least:

    1. a)
      a systematic description of the envisaged processing operations and the purposes of the processing, including, where applicable, the legitimate interest pursued by the controller;
    2. b)
      an assessment of the necessity and proportionality of the processing operations in relation to the purposes;
    3. c)
      an assessment of the risks to the rights and freedoms of data subjects referred to in paragraph 1; and
    4. d)
      the measures envisaged to address the risks, including safeguards, security measures and mechanisms to ensure the protection of personal data and to demonstrate compliance with this Regulation taking into account the rights and legitimate interests of data subjects and other persons concerned.
  8. 8.

    Compliance with approved codes of conduct referred to in Article 40 by the relevant controllers or processors shall be taken into due account in assessing the impact of the processing operations performed by such controllers or processors, in particular for the purposes of a data protection impact assessment.

  9. 9.

    Where appropriate, the controller shall seek the views of data subjects or their representatives on the intended processing, without prejudice to the protection of commercial or public interests or the security of processing operations.

  10. 10.

    Where processing pursuant to point (c) or (e) of Article 6(1) has a legal basis in Union law or in the law of the Member State to which the controller is subject, that law regulates the specific processing operation or set of operations in question, and a data protection impact assessment has already been carried out as part of a general impact assessment in the context of the adoption of that legal basis, paragraphs 1 to 7 shall not apply unless Member States deem it to be necessary to carry out such an assessment prior to processing activities.

  11. 11.

    Where necessary, the controller shall carry out a review to assess if processing is performed in accordance with the data protection impact assessment at least when there is a change of the risk represented by processing operations.

Enforcement

Cited in 101 fines totalling €509.6M

Top authority: 🇪🇺Italian Data Protection Authority (Garante) (31) · median fine €55,000 · see all enforcement for Art. 35 →

Connections by provision

35(1) 9 Case Law 20 Enforcement 148 Guidance 1 Literature .md
Guidance 148
Opinion 2/2019 on the draft list of the competent supervisory authority of Norway regarding the processing operations subject to the requirement of a data protection impact assessment (Article 35.4 GDPR) Opinion 5/2018 on the draft list of the competent supervisory authorities of Germany regarding the processing operations subject to the requirement of a data protection impact assessment (Article 35.4 GDPR) Opinion 9/2018 on the draft list of the competent supervisory authority of France regarding the processing operations subject to the requirement of a data protection impact assessment (Article 35.4 GDPR) Opinion 22/2018 on the draft list of the competent supervisory authority of the United Kingdom regarding the processing operations subject to the requirement of a data protection impact assessment (Article 35.4 GDPR) Opinion 1/2018 on the draft list of the competent supervisory authority of Austria regarding the processing operations subject to the requirement of a data protection impact assessment (Article 35.4 GDPR) Opinion 25/2018 on the draft list of the competent supervisory authority of Croatia regarding the processing operations subject to the requirement of a data protection impact assessment (Article 35.4 GDPR) Opinion 15/2018 on the draft list of the competent supervisory authority of Malta regarding the processing operations subject to the requirement of a data protection impact assessment (Article 35.4 GDPR) Opinion 18/2018 on the draft list of the competent supervisory authority of Portugal regarding the processing operations subject to the requirement of a data protection impact assessment (Article 35.4 GDPR) +140 more
35(2) 2 Enforcement 6 Guidance .md
35(3) 4 Case Law 4 Enforcement 125 Guidance .md
Guidance 125
Opinion 10/2018 on the draft list of the competent supervisory authority of Hungary regarding the processing operations subject to the requirement of a data protection impact assessment (Article 35.4 GDPR) Opinion 12/2018 on the draft list of the competent supervisory authority of Italy regarding the processing operations subject to the requirement of a data protection impact assessment (Article 35.4 GDPR) Opinion 6/2024 on the draft list of the Latvian SA on pro-cessing operations exempt from the data protection impact assessment requirement (Art. 35.5 GDPR) Opinion 7/2020 on the draft list of the competent supervisory authority of France regarding the processing operations exempt from the requirement of a data protection impact assessment (Article 35(5) GDPR) Opinion 11/2019 on the draft list of the competent supervisory authority of the Czech Republic regarding the processing operations exempt from the requirement of a data protection impact assessment (Article 35(5) GDPR) Opinion 13/2019 on the draft list of the competent supervisory authority of France regarding the processing operations exempt from the requirement of a data protection impact assessment (Article 35(5) GDPR) EDPB- EDPS Joint Opinion 01/2025 on the Proposal for a Regulation on simplification measures for SMEs and SMCs, in particular the record-keeping obligation under Art. 30(5) GDPR Opinion 12/2019 on the draft list of the competent supervisory authority of Spain regarding the processing operations exempt from the requirement of a data protection impact assessment (Article 35(5) GDPR) +117 more
35(3)(a) 2 Case Law .md
35(3)(b) 6 Case Law 4 Guidance .md
35(3)(c) 5 Guidance .md
35(4) 3 Case Law 52 Guidance 1 Literature .md
35(5) 30 Guidance .md
35(6) 3 Enforcement 19 Guidance .md
Guidance 19
Opinion 13/2019 on the draft list of the competent supervisory authority of France regarding the processing operations exempt from the requirement of a data protection impact assessment (Article 35(5) GDPR) Opinion 7/2020 on the draft list of the competent supervisory authority of France regarding the processing operations exempt from the requirement of a data protection impact assessment (Article 35(5) GDPR) Opinion 10/2019 on the draft list of the competent supervisory authority of Cyprus regarding the processing operations subject to the requirement of a data protection impact assessment (Article 35(4) GDPR) Opinion 11/2019 on the draft list of the competent supervisory authority of the Czech Republic regarding the processing operations exempt from the requirement of a data protection impact assessment (Article 35(5) GDPR) EDPB Document on response to the request from the European Commission for clarifications on the consistent application of the GDPR, focusing on health research Opinion 6/2024 on the draft list of the Latvian SA on pro-cessing operations exempt from the data protection impact assessment requirement (Art. 35.5 GDPR) ¶7 Opinion 10/2019 on the draft list of the competent supervisory authority of Cyprus regarding the processing operations subject to the requirement of a data protection impact assessment (Article 35(4) GDPR) ¶61 EDPB Document on response to the request from the European Commission for clarifications on the consistent application of the GDPR, focusing on health research +11 more
35(7) 1 Case Law 10 Enforcement 2 Guidance .md
35(7)(b) 6 Enforcement 2 Guidance .md
35(7)(c) 4 Case Law .md
35(7)(d) 2 Guidance .md
35(8) 6 Guidance .md
35(9) 2 Guidance 1 Literature .md
35(10) 8 Case Law 4 Guidance .md
35(11) 2 Guidance .md