1. The EEA shall collect human biomonitoring data generated within the territory of the EEA’s member and cooperating countries. In the case of occupational human biomonitoring data, the EEA shall cooperate with the ECHA.
2. By 2 January 2029, the Commission shall transfer any human biomonitoring data it holds to the EEA.
3. The EEA shall process human biomonitoring data constituting personal data for the following purposes only:
(a) assessing the impact of chemicals on human health and the environment;
(b) monitoring time and spatial trends in exposure;
(c) developing health risk and impact indicators;
(d) monitoring the impact of regulatory intervention;
(e) supporting regulatory risk assessments and regulatory risk management;
(f) supporting policy making and the development of legislation;
(g) facilitating the processing of human biomonitoring data by the Commission, the ECHA, the EFSA, the EMA, and EU-OSHA in accordance with paragraphs 4 to 8.
4. The Commission shall process human biomonitoring data constituting personal data for the following purposes only:
(a) assessing the impact of chemicals on human health and the environment;
(b) monitoring time and spatial trends in exposure;
(c) developing health risk and impact indicators;
(d) monitoring the impact of regulatory intervention;
(e) assessing the need for regulatory action and prioritising such action;
(f) performing regulatory risk assessment and regulatory risk management;
(g) supporting policy making and the development of legislation, including by carrying out scientific research to that effect;
(h) in the context of studies under the data generation mechanism referred to in Article 24 and the human biomonitoring study referred to in Article 25.
5. The ECHA shall process human biomonitoring data constituting personal data for the following purposes only:
(a) assessing the impact of chemicals on human health and the environment;
(b) monitoring time and spatial trends in exposure;
(c) developing health risk and impact indicators;
(d) monitoring the impact of regulatory intervention;
(e) performing regulatory risk assessment and regulatory risk management;
(f) in the context of studies under the data generation mechanism referred to in Article 24 and the human biomonitoring study referred to in Article 25;
(g) assessing the need for regulatory action and prioritising such action;
(h) supporting policy making and the development of legislation, including by carrying out scientific research to that effect;
(i) facilitating the processing of human biomonitoring data by the Commission, the EEA, the EFSA, the EMA, and EU-OSHA in accordance with paragraphs 3, 4, 6 and 7.
6. The EFSA shall process human biomonitoring data constituting personal data for the following purposes only:
(a) assessing the impact of chemicals on human health and the environment;
(b) monitoring time and spatial trends in exposure;
(c) developing health risk and impact indicators;
(d) in the context of studies under the data generation mechanism referred to in Article 24 and the human biomonitoring study referred to in Article 25;
(e) performing regulatory risk assessment and supporting regulatory risk management;
(f) assessing the need for regulatory action and prioritising such action;
(g) monitoring the impact of regulatory intervention;
(h) supporting policy making and the development of legislation, including by carrying out scientific research to that effect.
7. The EMA shall process human biomonitoring data constituting personal data for the following purposes only:
(a) assessing the impact of chemicals on human health and the environment;
(b) monitoring time and spatial trends in exposure;
(c) performing regulatory risk assessment and supporting regulatory risk management;
(d) assessing the need for regulatory action and prioritising such action;
(e) monitoring the impact of regulatory intervention;
(f) supporting policy making and the development of legislation, including by carrying out scientific research to that effect.
8. EU-OSHA shall process human biomonitoring data constituting personal data for the following purposes only:
(a) assessing the impact of chemicals on human health and the environment;
(b) monitoring time and spatial trends in exposure;
(c) monitoring the impact of regulatory intervention;
(d) assessing the need for regulatory action and prioritising such action;
(e) supporting regulatory risk assessment and regulatory risk management;
(f) supporting policy making and the development of legislation, including by carrying out scientific research to that effect;
(g) developing health risk and impact indicators.
9. Any processing of human biomonitoring data constituting personal data by the Agencies or the Commission for the purposes referred to in paragraphs 3 to 8 of this Article shall not entail the sharing of such data with third parties other than those within the meaning of Article 4, point (10) of Regulation (EU) 2016/679 and Article 3, point (14) of Regulation (EU) 2018/1725.
10. The EEA and the ECHA shall make human biomonitoring data they hold or host publicly available in anonymised form through the IPCHEM.
11. The Agencies and the Commission shall act as data controller for the human biomonitoring data constituting personal data they hold, host or process for the purposes referred to in paragraphs 3 to 8.
12. The EEA and the ECHA shall determine the storage period for the human biomonitoring data constituting personal data that they hold as well as the criteria used for that purpose, and shall review that period and those criteria.
13. For the purposes of this Article, human biomonitoring data include personal data collected before the entry into force of this Regulation in accordance with relevant data protection rules.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.