Subject matter and scope
1. This Regulation aims to ensure the efficient delivery of consistent hazard and risk assessments of chemicals where those assessments are required by Union legal acts, in order to achieve a high level of protection of human health and the environment, enable the development and use of safe and sustainable chemicals, ensure the proper functioning of the single market for chemicals, improve the Union’s citizens’ knowledge about, and trust in, the scientific basis for the decisions taken under Union legal acts on chemicals, and to contribute to the replacement and reduction of animal testing wherever possible.
2. To achieve the objectives referred to in paragraph 1, this Regulation lays down measures to:
(a)
bring together chemicals data and ensure that such data are easily findable accessible, interoperable and reusable;
(b)
keep records of studies commissioned by business operators in the context of fulfilling their obligations under Union law on chemicals;
(c)
establish the widest possible scientific basis for the implementation and development of Union law and policy related to chemicals;
(d)
establish an early warning and action system for emerging chemical risks.
3. This Regulation applies to chemicals data as referred to in Article 3(2) and (3).
Definitions
For the purpose of this Regulation, the following definitions apply:
(1)
‘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’);
(2)
‘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;
(3)
‘duty holder’ means a natural or legal person responsible for meeting obligations under the Union legal acts listed in Annex I;
(4)
‘business operator’ means a duty holder which is a private or public undertaking;
(5)
‘human biomonitoring data’ means data on concentrations of chemicals measured in human matrices such as blood or urine;
(6)
‘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;
(7)
‘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;
(8)
‘originating Union act’ means the Union legal act pursuant to which chemicals data and information were generated or submitted;
(9)
‘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;
(10)
‘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;
(11)
‘environmental sustainability-related data’ means any data relevant for the environmental sustainability assessment of a chemical or material throughout its entire life cycle, including:
(a)
data on resources, including raw materials, water, energy, fossil fuels and land;
(b)
data on emissions, including of greenhouse gases, eutrophication-relevant substances, dust and all other polluting substances; and
(c)
data on by-products originating during the chemical’s life cycle that can be used as resources for other production processes, including hydrogen and carbon monoxide;
(12)
‘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;
(13)
‘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;
(14)
‘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;
(15)
‘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;
(16)
‘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;
(17)
‘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;
(18)
‘the public’ means one or more natural or legal persons, and associations, organisations or groups of such persons.
