Recitals
- Recital (1)The communication of the Commission of 11 December 2019 on the European Green Deal sets high ambitions for enabling the transition towards…
- Recital (2)The main objective of this Regulation is to increase the level of protection of the environment and human health from the risks arising…
- Recital (3)Under Decision (EU) 2022/591 of the European Parliament and of the Council, harnessing the potential of digital and data technologies to…
- Recital (4)In its communication of 19 February 2020 on a European strategy for data, the Commission described its vision of a common European data…
- Recital (5)This Regulation also aims to implement the principles laid out in the proposal for an Interoperable Europe Act in the chemicals sector by…
- Recital (6)Business operators and competent authorities of the Member States are required by various Union legal acts to submit data and information…
- Recital (7)Unless this Regulation specifies otherwise, the common data platform should contain, but not be limited to, all chemicals-related data and…
- Recital (8)While some medicinal products are also chemicals and are relevant to the objectives of this Regulation, the application and use of hazard…
- Recital (9)Taking due account of the administrative work for the EMA from the adaptation of such data to an appropriate format for incorporation in…
- Recital (10)Other chemicals data submitted or generated under Union legal acts on medicinal products could also be of relevance to chemicals regulatory…
- Recital (11)In order to add data to be made available by the EMA through the common data platform where relevant to support the achievement of the…
- Recital (12)Due to the sensitivity of the information on the exact chemical composition of mixtures placed on the market and classified as hazardous on…
- Recital (13)To safeguard the ability of the European Commission, of the Agencies and of the competent authorities of the Member States to carry out…
- Recital (14)In order to respond to the needs of the digital economy and to ensure a high level of protection of the environment and human health, it is…
- Recital (15)Chemicals data and information generated as a result of obligations laid down by Union legal acts on chemicals could contain commercially…
- Recital (16)When using data contained in the common data platform, the Authorities should respect the originator principle. Under that principle, the…
- Recital (17)To ensure the protection of legitimate expectations of duty holders when generating or submitting data or information under the Union legal…
- Recital (18)When processing or disclosing personal data contained in the common data platform, the Agencies and the Commission should comply with…
- Recital (19)Given that the Agencies would be required to store scientific data which includes confidential and personal data, it is necessary to ensure…
- Recital (20)While the ECHA should identify and develop the technical functionalities of the common data platform in stages, certain dedicated services…
- Recital (21)The Commission should adopt an implementation plan identifying datasets of chemicals data to be made accessible via the common data…
- Recital (22)When exercising implementing powers, and in the cases in which Regulation (EU) No 182/2011 of the European Parliament and of the Council…
- Recital (23)The common data platform should serve the widest possible community and should have the ability to address new use cases, incorporate new…
- Recital (24)In order to bring together all relevant chemicals data and information in the common data platform, the Commission and the Agencies should…
- Recital (25)To ensure that an adequate knowledge base on chemicals is available through the common data platform, the Commission should be able to…
- Recital (26)Some types of data are currently not within the mandate of any of the Agencies. In order to ensure clarity with regard to the…
- Recital (27)To improve the uptake of academic data and to expand the knowledge base for safety assessments of chemicals and for environmental…
- Recital (28)The EEA, as the agency responsible for monitoring data and information on chemicals in the environment, should also be responsible for…
- Recital (29)The Agencies and the Commission should be able to process human biomonitoring data constituting personal data. Since human biomonitoring…
- Recital (30)Human biomonitoring data collected prior to the entry into force of this Regulation should be included in the common data platform to…
- Recital (31)The Agencies and the Commission should be able to process human biomonitoring data constituting personal data to assess the impact of…
- Recital (32)In order to ensure that appropriate safeguards are in place to secure the protection of human biomonitoring data constituting personal…
- Recital (33)In order to prevent any disruption to the current operation and functioning of IPCHEM, the ECHA should incorporate IPCHEM in the common…
- Recital (34)In order to promote the use and harmonisation of reference values among risk assessors and risk managers across different Union legal acts…
- Recital (35)In order to increase transparency, as well as to enable Authorities to have complete prior knowledge of studies commissioned by business…
- Recital (36)Under Regulation (EC) No 178/2002, business operators and laboratories are obliged to notify to the database of study notifications…
- Recital (37)To ensure consistency between those two study notification mechanisms, as well as to ensure certainty for business operators that are…
- Recital (38)While the obligation to notify studies under this Regulation should apply in the context of all the Union legal acts on chemicals listed in…
- Recital (39)Nevertheless, to ensure compliance with the obligation to notify studies under this Regulation, and to cater for the specificities of…
- Recital (40)In order to facilitate enforcement by Member States, the Agencies responsible for assessing and providing scientific output, including…
- Recital (41)While Regulation (EC) No 178/2002 also requires the consultation of stakeholders and the public following the notification to the EFSA of…
- Recital (42)Under the mechanism for study notifications established by Regulation (EC) No 1907/2006, where registrants are required to perform studies…
- Recital (43)To strengthen the coordination and cooperation between the different bodies performing chemicals assessments in the Union, and to promote…
- Recital (44)The use of articles or products containing chemicals could lead to exposure to those chemicals. Knowledge about the presence of chemicals…
- Recital (45)In order to support and promote research and development as regards alternatives to substances of concern, and to promote the uptake of…
- Recital (46)The existing project The EU Chemicals Legislation Finder, managed by the ECHA, makes it easier to find and identify legal obligations…
- Recital (47)In order to ensure that chemicals data are easily findable in the common data platform and that all relevant data on a specific chemical or…
- Recital (48)The Agencies and the Commission should specify appropriate controlled vocabularies for data they receive and store and, where relevant,…
- Recital (49)In order to promote the interoperability of database systems on chemicals beyond the common data platform, the ECHA should establish a…
- Recital (50)The International Uniform Chemical Information Database (IUCLID) is a software application designed to record, store, maintain and exchange…
- Recital (51)In order to support the uptake of peer-reviewed published research data in regulatory assessments of chemicals and the implementation of…
- Recital (52)To increase the availability and facilitate the use of information on the environmental performance of chemicals throughout their…
- Recital (53)To monitor the impacts on humans and the environment, including the climate, of exposure to chemicals and to establish a knowledge base to…
- Recital (54)This Regulation should establish an early warning and action system to identify emerging chemical risks and enable early regulatory…
- Recital (55)In June 2017, at the Commission’ request, the ECHA set up the European Observatory for Nanomaterials (EUON), which collects existing data…
- Recital (56)The ECHA should continue operating the EUON and transform it into an observatory for specific chemicals and groups of chemicals with the…
- Recital (57)The observatory should not be regarded as a substitute for required risk management action on any chemical in cases where a hazard or risk…
- Recital (58)Under Regulation (EC) No 178/2002, the EFSA is able to commission, in an open and transparent manner, the scientific studies it needs to…
- Recital (59)To gather information on the exposure of European citizens to chemicals, to support the effective implementation and evaluation of Union…
- Recital (60)In order to ensure the optimal functioning of this Regulation and to stay abreast of technological and legislative developments, the…
- Recital (61)In order to adjust the content of Annex I, which should list all Union legal acts pursuant to which chemicals data are generated or…
- Recital (62)In order to adjust the content of Annex II, which should list relevant reference values resulting from the implementation of Union legal…
- Recital (63)In order to adjust the content of Annex III, which should list all Union legal acts pursuant to which regulatory processes on chemicals or…
- Recital (64)In order to adjust the content of Annex V, which should list Union legal acts pursuant to which data on chemicals in articles or products…
- Recital (65)It is of particular importance that the Commission carry out appropriate consultations during its preparatory work in relation to the…
- Recital (66)Since the objectives of this Regulation, namely to ensure the efficient delivery of consistent hazard and risk assessments of chemicals…
- Recital (67)The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered an…
Text as published in the Official Journal; for the authentic version, see EUR-Lex.
