- Agencies
means the European Chemicals Agency (the ‘ECHA’), the European Environment Agency (the ‘EEA’), the European Food Safety Authority (the ‘EFSA’), the European Medicines Agency (the ‘EMA’) and the European Agency for Safety and Health at Work (‘EU-OSHA’);
- Authorities
means the Commission, the competent authorities of the Member States as referred to in any of the Union legal acts listed in Annexes I or III, and the Agencies, excluding their management boards;
- business operator
means a duty holder which is a private or public undertaking;
- chemicals data
means any representation of facts or information relating to chemicals and any compilation of such facts or information, including information on physicochemical properties, hazard properties, use, exposure, risk, occurrence, emissions, fate and manufacturing process of chemicals, as well as environmental sustainability-related information on chemicals, including climate change-related information, regulatory process-related information on chemicals, data on alternatives to substances of concern, standard formats, controlled vocabularies, or any information on applicable legal obligations relating to chemicals;
- controlled vocabularies
means standardised and organised arrangements of words and phrases presented as lists of terms or as a thesaurus, and taxonomies with a hierarchical structure of broader and narrower terms;
- data controller
means controller as defined in Article 4, point (7), of Regulation (EU) 2016/679 and as defined in Article 3, point (8), of Regulation (EU) 2018/1725;
- data processor
means a processor as defined in Article 4, point (8), of Regulation (EU) 2016/679, and as defined in Article 3, point (12), of Regulation (EU) 2018/1725;
- duty holder
means a natural or legal person responsible for meeting obligations under the Union legal acts listed in Annex I;
- environmental sustainability-related data
means any data relevant for the environmental sustainability assessment of a chemical or material throughout its entire life cycle, including:
- human biomonitoring data
means data on concentrations of chemicals measured in human matrices such as blood or urine;
- interoperability
means the ability of two or more data spaces or communication networks, systems, products, applications or components to exchange and use data in order to perform their functions;
- originating Union act
means the Union legal act pursuant to which chemicals data and information were generated or submitted;
- originator
means the Commission or the agency or competent authority of a Member State responsible for confidentiality assessments under any Union legal act listed in Annex I;
- peer-reviewed published research data
means any chemicals data derived from scientific studies that are published in peer-reviewed publications and that are not carried out specifically for the purposes of regulatory assessments;
- personal data
means personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679 and as defined in Article 3, point (1), of Regulation (EU) 2018/1725;
- processing
means processing as defined in Article 4, point (2), of Regulation (EU) 2016/679 and as defined in Article 3, point (3), of Regulation (EU) 2018/1725;
- reference value
means an estimate of a maximum exposure level or emission level of a chemical below which no or only acceptable adverse effects on human health or the environment are expected, or below which risks related to adverse effects of that chemical on human health or the environment are considered acceptable or tolerable;
- the public
means one or more natural or legal persons, and associations, organisations or groups of such persons.