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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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Identification of previous registrant(s)
and other potential registrant(s)
• “Matching” is based on
– Name
– Composition
– Analytical data
http://echa.europa.eu
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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
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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
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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
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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
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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
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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
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http://echa.europa.eu
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