Adina Vălean

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

(33) The development of certain AI systems and AI models may involve the collection of large amounts of data, including personal data and special categories thereof. Special categories of personal data may residually exist in the training, testing or validation data sets or be retained in the AI system or the AI model, although the special categories of personal data are not necessary for the purpose of the processing. In order not to disproportionately hinder the development and operation of AI and taking into account the capabilities of the controller to identify and remove special categories of personal data, derogating from the prohibition on processing special categories of personal data under Article 9(2) of Regulation (EU) 2016/679 should be allowed. The derogation should only apply where the controller has implemented appropriate technical and organisational measures in an effective manner to avoid the processing of those data, takes the appropriate measures during the entire lifecycle of an AI system or AI model and, once it identifies such data, effectively remove them. If removal would require disproportionate effort, notably where the removal of special categories of data memorised in the AI system or AI model would require re-engineering the AI system or AI model, the controller should effectively protect such data from being used to infer outputs, being disclosed or otherwise made available to third parties. This derogation should not apply where the processing of special categories of personal data is necessary for the purpose of the processing. In this case, the controller should rely on the derogations pursuant to Article 9(2)(a) – (j) of Regulation (EU) 2016/679.

Amendment

(33) The development of certain AI systems and AI models may involve the collection of large amounts of data, including which may include personal data and special categories thereof. Special categories of personal data may incidentally and residually exist in the training, testing or validation data sets or be retained in the AI system or the AI model, although the special categories of personal data are not necessary for the purpose of the processing and while the controller did not intend to process such personal data and has taken the appropriate technical and organisational measures to avoid such processing, such as the filtering out of special categories of personal data at the collection stage. In order not to disproportionately hinder the development and operation of AI and taking into account the capabilities of the controller to identify and remove special categories of personal data, including technical capabilities derogating from the prohibition on processing special categories of personal data under Article 9(2) of Regulation (EU) 2016/679 should be allowed for incidental and residual processing of special categories of data in the context of the development and technical operation of AI systems or AI models. The derogation should not be understood as covering the processing of special categories of personal data directly acquired by or provided to the AI system or AI model in the course of the deployment. The derogation should only apply where the controller has implemented appropriate technical and organisational measures in an effective manner to avoid the processing of those data, takes the appropriate measures during the entire lifecycle, such as the development and operation, of an AI system or AI model, and, once it identifies such data, effectively remove them. If removal would require manifestly disproportionate effort, notably where the removal of special categories of data memorised in the AI system or AI model would require re-engineering the AI system or AI model the controller should effectively protect such data from being further processed or processed for other purposes, in particular used to infer outputs, being disclosed or otherwise made available to third parties. The controller should document its assessment and have processes in place to monitor and demonstrate the effectiveness of these measures. This derogation should not apply where the processing of special categories of personal data is necessary for the purpose of the processing, for example if special categories of personal data relating to a natural person’s voice, image or other personal characteristics are used in a way that goes beyond incidental or residual existence. In this case, the controller should rely on the derogations pursuant to Article 9(2)(a) – (j) of Regulation (EU) 2016/679 or in another Union law, such as Regulation (EU) 2024/1689 regarding the processing of special categories of personal data for the purpose of ensuring bias detection and correction. The notion of AI system and AI model should be understood in the same manner as in Regulation (EU) 2024/1689.

Text proposed by the Commission

Information relating to a natural person is not necessarily personal data for every other person or entity, merely because another entity can identify that natural person. Information shall not be personal for a given entity where that entity cannot identify the natural person to whom the information relates, taking into account the means reasonably likely to be used by that entity. Such information does not become personal for that entity merely because a potential subsequent recipient has means reasonably likely to be used to identify the natural person to whom the information relates.

Amendment

Information relating to a natural person, depending on the circumstances of the case, is not necessarily personal data for every other person or entity, in so far as that person or entity cannot identify that natural person to whom the information relates taking into account the means reasonably likely to be used by that person or entity, Information relating to a natural person is, however, personal data where this information is likely to be put or is put at the disposal of other persons or entities who have the means reasonably likely to enable the data subject to be identified.

Text proposed by the Commission

(38) “scientific research” means any research which can also support innovation, such as technological development and demonstration. These actions shall contribute to existing scientific knowledge or apply existing knowledge in novel ways, be carried out with the aim of contributing to the growth of society´s general knowledge and wellbeing and adhere to ethical standards in the relevant research area. This does not exclude that the research may also aim to further a commercial interest.

Amendment

(38) “scientific research” means creative and systematic work undertaken in order to increase the stock of knowledge, either through experimental or theoretical work undertaken primarily to acquire new knowledge of the underlying foundations of phenomena and observable facts without any particular application or use in view, or through original investigation undertaken in order to acquire new knowledge directed primarily towards a specific, practical aim or objective. This does not exclude that the research may also aim to further a commercial interest.

Text proposed by the Commission

(k) processing in the context of the development and operation of an AI system as defined in Article 3, point (1), of Regulation (EU) 2024/1689 or an AI model, subject to the conditions referred to in paragraph 5.

Amendment

(k) incidental and residual processing in the context of the development, training, testing, deployment and operation of an AI system as defined in Article 3, point (1), of Regulation (EU) 2024/1689 or an AI model as referred to in Regulation (EU) 2024/1689, including for the improvement of such systems or models and of related products or services, subject to the conditions referred to in paragraph 5.

Text proposed by the Commission

Amendment

(la) processing is strictly necessary for the recognition, management or payment of retirement, disability, dependency or other related pension benefits, where such processing is required by contract or legal provision governing the pension plan, for the sole purpose of verifying and administering the conditions for entitlement, and is subject to appropriate and specific safeguards to protect the fundamental rights and interests of the data subject, including data minimisation, purpose limitation, restricted access and professional secrecy. This provision shall not affect the validity of other legal bases currently relied upon under this Regulation for the processing of health data related to the treatment of certain pension benefits.

Text proposed by the Commission

Amendment

(lb) In Article 9, paragraph 2, the following point is added: 'lb. processing is necessary and proportionate for the prevention of fraud, the detection and prevention of abuse, bot and spam activity, identity misuse, account takeover or payment fraud, or for ensuring the security of accounts, payments and transactions, provided that the processing is subject to appropriate safeguards for the rights and freedoms of the data subject.'

Text proposed by the Commission

(b) providing a service explicitly requested by the data subject;

Amendment

(b) providing a service or the maintenance of a user session explicitly requested by the data subject;

Text proposed by the Commission

Amendment

(ca) In Article 83, paragraph 3, the following point ca is inserted: '(ca) performing audience measurement in compliance with Article 24 of Regulation (EU) 2024/1083.'

Text proposed by the Commission

(d) maintaining or restoring the security of a service provided by the controller and requested by the data subject or the terminal equipment used for the provision of such service.

Amendment

(d) maintaining or restoring the security, integrity and functioning of a service provided by the controller and requested by the data subject or the security of the terminal equipment used for the provision of such service, including detecting, preventing or mitigating fraud, automated or non-human traffic, unauthorised access, misuse of the service, circumvention of technical access conditions, or other uses that are contrary to the provider’s terms and conditions

Text proposed by the Commission

Amendment

(da) In Article 88a, paragraph 3, the following point da is added: '(da) legitimate purposes in relation to contextual advertising, including measuring the performance and reach of such advertisement or capping the frequency with which such advertisement is being displayed.'

Text proposed by the Commission

Amendment

(db) In Article 88a, paragraph 3, the following point db is added: '(db) ‘legitimate interests’ according to Article 6(1)(f) of this regulation provided that the controller applies Privacy Enhancing Technologies (PETs) in accordance with the technical standards adopted pursuant to Article 25a. This point shall not apply to processing operations that involve tracking or profiling a data subject's behaviour for the purposes of behavioural advertising, regardless of whether there is a direct relationship with the data subject. This does not preclude the processing of data for internal product optimisation, provided such processing is not used to track the user.'

Text proposed by the Commission

(a) the data subject shall be able to refuse requests for consent in an easy and intelligible manner with a single-click button or equivalent means;

Amendment

(a) the data subject shall be able to refuse requests for consent in an easy and intelligible manner with a single-click button or equivalent means, except where the controller is a media service provider as defined in Article 2 (2) of Regulation (EU) 2024/108

Text proposed by the Commission

(c) if the data subject declines a request for consent, the controller shall not make a new request for consent for the same purpose for a period of at least six months.

Amendment

(c) if the data subject declines a request for consent, the controller shall not make a new request for consent for the same purpose for a period of at least six months, except where the controller is a media service provider as defined in Article 2 (2) of Regulation (EU) 2024/108.

Text proposed by the Commission

Amendment

(4a) In Article 88a, the following paragraph 4a is inserted: '4a. Nothing in this Article shall prevent a media service provider from making access to its service conditional on either the data subject's consent to the processing of personal data for one or more specified purposes, or the payment of a reasonable fee for access to an equivalent version that does not involve such processing. Where such is offered, both options shall be presented to the data subject with equal prominence, in plain language and without the use of dark patterns.'

Text proposed by the Commission

(3) Paragraphs 1 and 2 shall not apply to controllers that are media service providers when providing a media service.

Amendment

(3) Paragraphs 1 and 2 shall not apply to controllers that are media service providers when providing a media service. This exemption extends to all processing carried out by or on behalf of a media service provider in connection with the provision of the media service.

Text proposed by the Commission

The Commission shall, in accordance with Article 10(1) of Regulation (EU) 1025/2012, request one or more European standardisation organisations to draft standards for the interpretation of machine-readable indications of data subjects’ choices.

Amendment

The Commission shall, in accordance with Article 10(1) of Regulation (EU) 1025/2012, request one or more European standardisation organisations to draft standards for the interpretation of machine-readable indications of data subjects’ choices. The European standardisation organisations shall, where appropriate, take into account existing international standards developed by international standardisation organisations, as well as emerging technical specifications developed by relevant industry consortia. When drawing up the standardisation mandate, the Commission shall consult the European Data Protection Board and an advisory forum comprising representatives of controllers, data subjects, media service providers, consumer protection organisations, academia and civil society to ensure that standards reflect diverse perspectives and do not create new gatekeepers

Text proposed by the Commission

(6) Providers of web browsers, which are not SMEs, shall provide the technical means to allow data subjects to give their consent and to refuse a request for consent and exercise the right to object pursuant to Article 21(2) through the automated and machine-readable means referred to in paragraph 1 of this Article, as applied pursuant to paragraphs 2 to 5 of this Article.

Amendment

(6) Rules set out in this Regulation should support the emergence of market-driven solutions with appropriate interfaces that provide the technical means to allow data subjects to give their consent and to refuse a request for consent and exercise the right to object pursuant to Article 21(2) through the automated and machine-readable means referred to in paragraph 1 of this Article ,and shall provide the technical means to allow media service providers to effectively use the exception pursuant to paragraph 3, as applied pursuant to paragraphs 2 to 5 of this article. The technical means should allow for granular choices, including category-based or purpose-based preferences, and shall enable data subjects to override global settings at the service level.