Identification of a substance and verification of substance identity How an inquiry dossier is processed by ECHA 25 May 2011 Suvi Takala ECHA – C2 Unit Substance Identification & Data Sharing Introduction to inquiry process • Data sharing under the REACH Regulation – Phase-in substances that have been pre-registered • Data sharing in SIEFs – Non phase-in substances and phase-in substances that have not been pre-registered • Inquiry process http://echa.europa.eu 2 Legal background • Article 26 regulates the inquiry process as follows: – 26(1) – inquiry to ECHA and information to be submitted; – 26(2) – communication in case of substances non-previously registered; – 26(3) – communication of name and contact details of previous registrant and potential registrant; communication in case of previously registered substance; – 26(4) – communication in case of several Potential Registrants making an inquiry about the same substance. http://echa.europa.eu 3 Legal background (cont.) • The inquiry dossier shall contain all the following information (Art. 26): – the identity of the potential registrant (Section 1 of Annex VI, with the exception of the use sites); – the identity of the substance (Section 2 of Annex VI); – information requirements that would require new studies involving vertebrate animals to be carried out; – information requirements that would require other new studies to be carried out. http://echa.europa.eu 4 General substance identity requirements under REACH 2.1.1 IUPAC name or other international chemical name 2.1.2 Other names (e.g. trade name) 2.1.3 EINECS or ELINCS number (if available) 2.1.4 CAS name and CAS number (if available) 2.1.5 Other identity code (if available) 2.2.1 Molecular and structural formula (including SMILES, if available) 2.2.2 Information on optical activity and typical ratio of (stereo) isomers (if applicable and appropriate) 2.2.3 Molecular weight or molecular weight range 2.3.1 Degree of purity (%) 2.3.2 Nature of impurities, including isomers and by-products 2.3.3 Percentage of (significant) main impurities 2.3.4 Nature and order of magnitude (e.g. ppm) of any additives (e.g. stabilising agents or inhibitors) 2.3.5 Spectral data (ultra-violet, infra-red, nuclear magnetic resonance or mass spectrum) 2.3.6 High-pressure liquid chromatogram, gas chromatogram 2.3.7 Description of analytical methods or the appropriate bibliographical references for the identification of the substance and, where appropriate, for the identification of impurities and additives. This information shall be sufficient to allow the methods to be reproduced. http://echa.europa.eu 5 Substance identity requirements • Annex VI (2) of the REACH Regulation states: “For each substance, the information given in this section shall be sufficient to enable each substance to be identified. If it is not technically possible or if it is does not appear scientifically necessary to give information on one or more of the items below, the reasons shall be clearly stated.” http://echa.europa.eu 6 Why correct and accurate substance identification is important • To ensure that ECHA can be confident in the chemical identity of each substance • To establish whether two (or more) substances are the same • To ensure data sharing and joint submission work effectively and correctly http://echa.europa.eu 7 How to inquire? • • Option 1 – Create inquiry dossier in IUCLID5 – Submit the dossier via REACH-IT Option 2 (since April 2009) – Create and submit inquiry dossier with Online Inquiry dossier Tool available in REACH-IT Further information on creating and submitting an inquiry dossier is available on ECHA webpage http://echa.europa.eu/reachit/inquiry_en.asp – Industry User Manual - Part 11: Online dossier creation and submission for inquiries – Data Submission Manual 2: How to prepare and submit an inquiry dossier – Industry User Manual - Part 6: Dossier Submission – Data Submission Manual 18: How to report the substance identity in IUCLID 5 for registration under REACH http://echa.europa.eu 8 Inquiry process at ECHA • • • • Substance identification assessment Identification of previous (potential) registrant(s) Identification of information available Communication of the results http://echa.europa.eu 9 Substance identification assessment • Identification – IUPAC name, structural formula, numerical identifiers, molecular formula, molecular weight,… • Composition – Main constituent(s), impurities, additives • Analytical data – Spectral, chromatographic and other relevant analytical data http://echa.europa.eu 10 Inquiry process at ECHA • • • • Substance identification assessment Identification of previous (potential) registrant(s) Identification of information available Communication of the results http://echa.europa.eu 11 Identification of previous registrant(s) and other potential registrant(s) • “Matching” is based on – Name – Composition – Analytical data http://echa.europa.eu 12 Inquiry process at ECHA • • • • Substance identification assessment Identification of previous (potential) registrant(s) Identification of information available Communication of the results http://echa.europa.eu 13 Inquiry process at ECHA • • • • Substance identification assessment Identification of previous (potential) registrant(s) Identification of information available Communication of the results http://echa.europa.eu 14 Communicating inquiry results Information given adequate to identify the substance • Inquiry number • EC number or technical number • Information on previous registrants • Information on data already available for this substance • Information on previous potential registrants • Recommended modifications • Instructions on how to contact ECHA http://echa.europa.eu 15 Communicating inquiry results Information given adequate to identify the substance • If the substance has been previously registered or inquired about – Contact details of the previous registrants, registrants that notified the substance under Biocidal Product Directive 98/8/EC and/or the Plant Protection Product Directive 91/414/EEC and/or previous potential registrants • IUCLID file for the EC number of for the technical number • Instructions to use IUCLID file attached http://echa.europa.eu 16 Informing previous registrants and/or previous potential registrants • Contact details of the potential registrant (or third party representative) • List of studies requested (if any) http://echa.europa.eu 17 Communicating inquiry results Information given not adequate to identify the substance • Required modifications • Recommended modifications • Instructions on how to contact ECHA about the same substance http://echa.europa.eu 18 http://echa.europa.eu 19