32025R2455#anx_IVRegulation (EU) 2025/2455 of the European Parliament and of the Council

Annex IV — Datasets to be included at the date of establishment of the common data platform

All chemicals data of the datasets specified in the table below shall be included in the common data platform, within three years of 1 January 2026. This includes data generated or submitted before 1 January 2026, unless specified otherwise, as well as data indicated in accordance with Article 5(2) as not being made available to the public under the originating Union act. DatasetDescriptionData provider Datasets behind dedicated servicesChemicals data covered by: IPCHEM (Article 7) This includes all chemicals data contained in the IPCHEM operated by the Commission before transfer of the operation to the ECHA.Commission Repository of reference values (Article 8) This includes the following data: (a) regulatory reference values formally adopted under Union legal acts listed in Annex I; (b) scientific reference values available in formal opinions delivered under Union legal acts listed in Annex I, Part 1; and (c) scientific reference values specified in Annex II resulting from relevant procedures that are concluded after the entry into force of this Regulation. Agencies Information on regulatory processes on chemicals (Article 10): This includes the following information: (a) information contained in the existing Activities Coordination Tool of the ECHA; (b) information on regulatory processes on chemicals available via the existing Open EFSA of the EFSA; and (c) other information as provided to the ECHA in accordance with Article 10. Authorities Information on the obligations under Union legal acts on chemicals (Article 13) This includes information on the obligations under Union legal acts listed in Annex I, including information available through the existing European Union Legislation Finder of the ECHA.ECHA Repository of standard formats and controlled vocabularies (Article 14) This includes standard formats and controlled vocabularies available in accordance with Article 14.Agencies, Commission REACH registrationsRegistration dossiers submitted under Title II of Regulation (EC) No 1907/2006.ECHA CLP classification and labelling inventoryClassification and labelling information submitted in registration dossiers under Title II of Regulation (EC) No 1907/2006 and notified under Title V of Regulation (EC) No 1272/2008; and Harmonised classification and labelling entries from Annex VI of Regulation (EC) No 1272/2008. ECHA BPR applications for approval and renewal of active substances and summaries of biocidal product characteristicsApplications for approval or renewal of approval of biocidal active substances under Chapter II and III of Regulation (EU) No 528/2012 and available in IUCLID; and Summaries of biocidal product characteristics submitted by applicants for Union authorisation under Chapter VIII of Regulation (EU) No 528/2012 and by applicants under Regulation (EU) No 414/2013 and available in IUCLID. ECHA DWD applications for inclusion of substances in the European positive listsApplications to add new entries, and to amend or remove existing entries from the European positive lists of substances in contact with drinking water, submitted by economic operators or relevant authorities under Article 13 of Directive (EU) 2020/2184.ECHA Study notificationsStudy notification information once a corresponding registration, application or other relevant regulatory dossier has been submitted and any confidentiality claims assessed: from the ECHA Database of Study Notifications referred to in Article 9 of this Regulation; and from the EFSA database referred to in Article 32b of Regulation (EC) No 178/2002 as made available to the ECHA in accordance with Article 9(4) of this Regulation. ECHA, EFSA Open Food ToxThe EFSA’s chemicals hazard database that compiles, in a structured format, EFSA chemical risk assessments including chemical identifiers, critical endpoints, toxicological reference values and metadata from EFSA outputs.EFSA Chemical monitoring dataEFSA chemical monitoring data covering multiple regulations under the EFSA’s remit and including chemical monitoring data for pesticides and veterinary medicinal product residues and contaminants data; the individual measurements of chemicals in food/feed and other materials sampled as part of official controls and enforcement activities; measurements of chemicals in food and feed received from industry; and other sources in response to a call for data. EFSA Food chainFood chain application dossiers containing chemicals data submitted through the E-submission Food Chain Platform by applicants under different regulated product areas under Regulation (EC) No 1831/2003, Regulation (EC) No 1935/2004, Regulation (EC) No 1924/2006 and Regulation (EU) 2015/2283 and available in structured formats.EFSA Applications under PPPRDossiers submitted by applicants under Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market, including the active substance, maximum residue levels and basic substance submission types and available in IUCLID.EFSA Air qualityAir quality data from a range of sources including time series of measurements from Europe’s air quality monitoring network; and statistics for air pollutants calculated from officially verified country data as compiled under Directive (EU) 2024/2881 but not including EEA-held near-real time information on air quality and associated data products e.g. Air Quality Index. EEA Waterbase water qualityTime series of concentrations of nutrients, organic matter, hazardous substances and other chemicals in rivers, lakes, groundwater, transitional, coastal and marine waters as reported in accordance with the Watch List for chemicals in surface waters under Directive 2000/60/EC (also identified as WISE-6).EEA Waterbase EmissionsTime series of emissions of nutrients and hazardous substances to water, reported on yearly riverine input loads to transitional, coastal and marine waters under Directive 2000/60/EC (also identified as WISE-1).EEA Industrial emissionsChemicals data on releases, transfers and emissions of regulated pollutants as reported by Member States into the European Pollutant Release and Transfer Register under Regulation (EC) No 166/2006 and Directive 2010/75/EU.EEA NEC emissions inventoryData on emissions of air pollutants as reported by Member States under Directive (EU) 2016/2284 and contained in the emission inventory.EEA Human medicinal products data on environmental risk assessment and non-clinical safety dataEnvironmental risk assessment and non-clinical safety data from marketing authorisation applications for medicinal products for human use under Directive 2001/83/EC and Regulation (EC) No 726/2004. This includes only data on relevant active substances submitted to the EMA in the context of the relevant procedures that are concluded after the entry into force of this Regulation.EMA Veterinary medicinal products data on environmental risk assessment and on maximum residue limitsEnvironmental risk assessment data, maximum residue limits (MRLs) values and MRL assessment data from marketing authorisation applications for medicinal products for veterinary use under Regulation (EU) 2019/6 and Regulation (EC) No 470/2009. This includes only data on relevant active substances submitted to the EMA in the context of the relevant procedures that are concluded after the entry into force of this Regulation.EMA

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