Eva Maydell

Text proposed by the Commission

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given entity where that entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council¹⁵ . The Commission, together with the European Data Protection Board, should support controllers in the application of this updated definition by stipulating technical criteria in an implementing act. _________________ ¹⁵ Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj)

Amendment

(27) This Regulation proposes a series of targeted amendments to Regulation (EU) 2016/679 for clarification and simplification, whilst preserving the same level of data protection. Article 4 of Regulation (EU) 2016/679 provides that personal data is any information relating to an identified or identifiable natural person. In order to determine whether a natural person is identifiable, account should be taken of all the means reasonably likely to be used to identify the natural person directly or indirectly. Taking into account the case-law of the Court of Justice of the European Union concerning the definition of personal data, it is necessary to provide further clarity on when a natural person should be considered to be identifiable. The existence of additional information enabling the data subject to be identified does not, in itself, mean that pseudonymised data must be regarded as constituting, in all cases and for every person or entity, personal data for the purposes of the application of Regulation (EU) 2016/679. In particular, it should be clarified that information is not to be considered personal data for a given person or entity where that person or entity does not have means reasonably likely to be used to identify the natural person to whom the information relates. To ascertain whether means are reasonably likely to be used to identify the natural person, account should be taken of all objective factors, such as the costs of and the amount of time required for identification, taking into consideration the available technology at the time of the processing and technological developments. The principles of data protection should therefore not apply to anonymous information, namely information which does not relate to an identified or identifiable natural person or to personal data rendered anonymous in such a manner that the data subject is not or no longer identifiable. A potential subsequent transmission of that information to third parties who have means reasonably allowing them to identify the natural person to whom the information relates, such as cross-checking with other data at their disposal, renders that information personal data only for those third parties who have such means at their disposal. An entity for which the information is not personal data, in principle, does not fall within the scope of application of Regulation (EU) 2016/679. In this respect the Court of Justice of the European Union has held that a means of identifying the data subject is not reasonably likely to be used where the risk of identification appears in reality to be insignificant, in that the identification of that data subject is prohibited by law or impossible in practice, for example because it would involve a disproportionate effort in terms of time, cost and labour. An example of a prohibition against reidentification can be found in the obligations of health data users in Article 61(3) of Regulation (EU) 2025/327 of the European Parliament and of the Council. It should also be clarified that information, which is apparently impersonal, may still be considered personal data if the data subject can be identified with additional information obtained from another person or entity through means reasonably likely to be used making it possible to identify the data subject. In such circumstances, the fact that the information enabling the data subject to be identified is in the hands of other people does not prevent that data subject from being identifiable for the controller. The Court of Justice of the European Union has also held that information which are in themselves impersonal may become personal in nature where the controller puts them, or is likely to put them, at the disposal of other persons or entities who have means reasonably likely to enable the data subject to be identified. It is apparent, in particular, that if that information is put at these other persons or entities’ disposal – then this information is personal data for these persons and entities and, indirectly, for the controller. Accordingly, in so far as it cannot be ruled out that those persons or entities have means reasonably allowing them to attribute pseudonymised data to the data subject, such as cross-checking with other data at their disposal, the data subject must be regarded as identifiable as regards both that transfer and any subsequent processing of those data by those persons and entities. In such circumstances, pseudonymised data should be considered to be personal data. The Commission, together with the European Data Protection Board, may support controllers in the application of this updated definition by stipulating technical criteria in an implementing act.

Text proposed by the Commission

(28) In order to assess whether research meets the conditions of scientific research for the purpose of this Regulation, account can be taken of elements such as methodological and systematic approach applied while conducting the research in the specific area. Research and technology development should be conducted in academic, industry and other settings, including small and medium-sized undertakings, (Article 179(2) TFEU) and should be always of a of high quality and should adhere to the principles of principles of reliability, honesty, respect and accountability (verifiability).

Amendment

(28) In order to assess whether an activity meets the conditions of being scientific research for the purpose of this Regulation, account should be taken of the following characteristics: novelty, creativity, uncertainty, systematic and transferable/reproducible. Consideration should also be given to the purpose of the activity, which should primarily aim at new findings, based on original concepts (and their interpretation) or hypotheses. The Frascati Manual will be the main reference for this assessment.

Text proposed by the Commission

(32) The processing of personal data for scientific research purposes and the application of the GDPR’s provisions on scientific research are conditional on the adoption of appropriate safeguards for the rights and freedoms of data subjects, pursuant to Article 89(1) GDPR. To that end, the GDPR balances the right to protection of personal data, pursuant to Article 8 CFREU, with the freedom of science, pursuant to Article 13 CFREU. The processing of personal data for the purpose of scientific research therefore pursues a legitimate interest within the meaning of Article 6(1)(f) of Regulation (EU) 2016/679, provided that such research is not contrary to Union or Member State law. This is without prejudice to the obligation of the controller to ensure that all other conditions of Article 6(1)(f) of Regulation (EU) 2016/679 as well as all other requirements and principles of that Regulation are met.

Amendment

(32) The processing of personal data for scientific research purposes and the application of the GDPR’s provisions on scientific research are conditional on the adoption of appropriate safeguards for the rights and freedoms of data subjects, pursuant to Article 89(1) GDPR. To that end, the GDPR seeks to ensure a proportionate balance between the right to protection of personal data, pursuant to Article 8 CFREU, with the freedom of science, pursuant to Article 13 CFREU. The processing of personal data for the purpose of scientific research therefore pursues a legitimate interest within the meaning of Article 6(1)(f) of Regulation (EU) 2016/679, provided that such research is not contrary to Union or Member State law. This is without prejudice to the obligation of the controller to ensure that all other conditions of Article 6(1)(f) of Regulation (EU) 2016/679 as well as all other requirements and principles of that Regulation are met.

Text proposed by the Commission

Amendment

(32a) The possibility of drawing conclusions regarding a data subject's health status through the combination, analysis or contextual interpretation of other data should not, in itself, result in the classification of such data as data concerning health for the purposes of Article 9. Data should only fall within the special category referred to in Article 9(1) where it directly and inherently discloses information concerning health, and not merely because such information could, in principle, be derived from it by a third party through further processing, enrichment or analysis.

Text proposed by the Commission

(40) Article 35 of that Regulation (EU) 2016/679 requires controllers to conduct a data protection impact assessment where the processing of personal data is likely to result in a high risk to the rights and freedoms of natural persons. The supervisory authorities established pursuant to that Regulation are required to establish and make public a list of the kind of processing operations which are subject to the requirement for a data protection impact assessment. In addition, the Regulation provides that supervisory authorities may establish and make public a list of the kind of processing operations for which no data protection impact assessment is required. In order to effectively contribute to the aim of convergence of the economies and to effectively ensure free flow of personal data between Member States, increase legal certainty, facilitate compliance by controllers and ensure a harmonised interpretation of the notion of a high risk to the rights and freedoms of data subjects, a single list of processing operations should be provided at EU level, to replace the existing national lists. In addition, the publication of a list of the type of processing operations for which no data protection impact assessment is required, which is currently optional, should be made mandatory. The lists of processing operations should be prepared by the Board and adopted by the Commission as an implementing act. In order to facilitate compliance by controllers, the Board should also prepare a common template and a common methodology for conducting data protection impact assessments, to be adopted by the Commission as an implementing act. The Commission should take due account of the proposals prepared by the Board and review them, as necessary, prior to adoption. In order to take account of technological developments, the lists and the common template and methodology should be reviewed at least every three years and updated where necessary.

Amendment

(40) Article 35 of Regulation (EU) 2016/679 requires controllers to conduct a data protection impact assessment where the processing of personal data is likely to result in a high risk to the rights and freedoms of natural persons. The supervisory authorities established pursuant to that Regulation are required to establish and make public a list of the kind of processing operations which are subject to the requirement for a data protection impact assessment. In addition, the Regulation provides that supervisory authorities may establish and make public a list of the kind of processing operations for which no data protection impact assessment is required. In order to effectively contribute to the aim of convergence of the economies and to effectively ensure free flow of personal data between Member States, increase legal certainty, facilitate compliance by controllers and ensure a harmonised interpretation of the notion of a high risk to the rights and freedoms of data subjects, a single list of processing operations should be provided at EU level, to replace the existing national lists. In addition, the publication of a list of the type of processing operations for which no data protection impact assessment is required, which is currently optional, should be made mandatory. The lists of processing operations should be prepared by the Board and adopted by the Commission as an implementing act. In order to facilitate compliance by controllers, the Board should also prepare a common template and a common methodology for conducting data protection impact assessments, to be adopted by the Commission as an implementing act. The Commission should take due account of the proposals prepared by the Board and review them, as necessary, prior to adoption. In order to take account of technological developments, the lists and the common template and methodology should be reviewed at least every three years and updated where necessary.

Text proposed by the Commission

(41) Regulation (EU) 2018/1725 of the European Parliament and of the Council¹⁶ applies to the processing of personal data by the Union institutions, bodies, offices and agencies. Directive (EU) 2016/680 of the European Parliament and of the Council¹⁷ applies to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties. Regulation (EU) 2018/1725 and Directive (EU) 2016/680 should be brough into alignment with the amendments to Regulation (EU) 2016/679 introduced by this Regulation. _________________ ¹⁶ Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39, ELI: http://data.europa.eu/eli/reg/2018/1725/oj). ¹⁷ Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89, ELI: http://data.europa.eu/eli/dir/2016/680/oj).

Amendment

(41) Regulation (EU) 2018/1725 of the European Parliament and of the Council¹⁶ applies to the processing of personal data by the Union institutions, bodies, offices and agencies. Directive (EU) 2016/680 of the European Parliament and of the Council¹⁷ applies to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties. Regulation (EU) 2018/1725 and Directive (EU) 2016/680 should be brought into alignment with the amendments to Regulation (EU) 2016/679 introduced by this Regulation. _________________ ¹⁶ Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39, ELI: http://data.europa.eu/eli/reg/2018/1725/oj). ¹⁷ Directive (EU) 2016/680 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data by competent authorities for the purposes of the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, and on the free movement of such data, and repealing Council Framework Decision 2008/977/JHA (OJ L 119, 4.5.2016, p. 89, ELI: http://data.europa.eu/eli/dir/2016/680/oj).

Text proposed by the Commission

6. The Board shall prepare and transmit to the Commission a proposal for a common template for notifying a personal data breach to the competent supervisory authority referred to in paragraph 1 as well as for a list of the circumstances in which a personal data breach is likely to result in a high risk to the rights and freedoms of a natural person. The proposals shall be submitted to the Commission within [OP date = nine months of the entry into application of this Regulation]. The Commission after due consideration reviews it, as necessary, and is empowered to adopt it by way of an implementing act in accordance with the examination procedure set out in Article 93(2).

Amendment

6. The Board shall establish and make public common template for notifying a personal data breach to the competent supervisory authority referred to in paragraph 1 as well as for a list of the circumstances in which a personal data breach is likely to result in a high risk to the rights and freedoms of a natural person and a list of the circumstances in which it is not likely to result in such a high risk.. The template and lists shall be available to the Commission within [OP date = nine months of the entry into application of this Regulation]. The Commission after due consideration reviews it, as necessary, and is empowered to adopt it by way of an implementing act in accordance with the examination procedure set out in Article 93(2). 7. The template and the list referred to in paragraph 6 shall be reviewed at least every three years and updated where necessary. The Board shall submit its assessment and possible proposals for updates to the Commission in due time. The Commission after due consideration of the proposals reviews them and is empowered to adopt any updates following the procedure in paragraph 6.’

Text proposed by the Commission

6. The Board shall prepare and transmit to the Commission a proposal for a common template and a common methodology for conducting data protection impact assessments.

Amendment

6. The Board shall establish a common template and a common methodology for conducting data protection impact assessments.

Text proposed by the Commission

(a) assess the state of the art of available techniques;

Amendment

(a) assess the state of the art of available techniques, such as privacy- enhancing technologies;

Text proposed by the Commission

(b) develop criteria and or categories for controllers and recipients to assess the risk of re-identification in relation to typical recipients of data.

Amendment

(b) develop criteria and or categories for controllers and recipients to assess the risk of re-identification in relation to typical recipients of data, taking into account objective factors such as cost, amount of time required, available technology, legal obligations.

Text proposed by the Commission

Amendment

(ba) In Article 41a, paragraph 2, the following point ba is added: '(ba) assess technical, administrative, organisational and contractual measures that can prevent the risk of re-identification.'

Text proposed by the Commission

11. In Article 57(1) is amended as follows:

Amendment

11. In Article 57, paragraph 1 is amended as follows: In paragraph 1, the following subparagraph is added: 'National supervisory authorities shall refrain from adopting guidelines, recommendations and best practices on matters already covered by guidelines, recommendations and best practices issued by the Board and, where necessary, shall update or repeal their national documentation adopted prior to guidelines, recommendations and best practices adopted by the Board in order to ensure consistency of interpretation of this Regulation.'

Text proposed by the Commission

Amendment

(ab) In Article 57, paragraph 1, the following point va is added: '(va) set up regulatory sandboxes to facilitate testing the compliance of specific techniques or technological solutions to be used for the data processing activities with the obligations under this Regulation or whether the data processing results in data that would be exempt from this Regulation.'

Text proposed by the Commission

Amendment

(3a) In Article 88b, the following paragraph is inserted: '3a. Where a data subject gives specific consent to a controller pursuant to Article 88a, such consent shall prevail over any conflicting automated or machine-readable indication referred to in paragraph 1.'

Text proposed by the Commission

Amendment

(7a) In Article 88b, the following paragraph is added: '7a. The Commission shall, by [insert date = 3 years after the date of entry into force of this Regulation], submit a report to the European Parliament and the Council on the functioning of this Article, including an assessment of: (a) the impact on user choice and competition; (b) the effectiveness of machine-readable indications in reducing consent fatigue; (c) the emergence of new gatekeeper risks; (d) the impact on European media service providers; and (e) the need for legislative amendment.'