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Substance identification and how to report it in IUCLID 6
Chemical Watch Expo
Laszlo Majoros
Scientific Officer
European Chemicals Agency
26 April 2017
Berlin
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• Easier and more transparent way to report information, giving better guidance on what is expected
• Manuals integrated
• Installation simplified
Improved IT tool
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IUCLID 6 released
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Content
• Reference substance
• Other regulatory substance identifiers in section 1.1.
• Section 1.2
• Type of composition
• State / form
• Description of composition
• Justification for deviations
• Function (of additive)
• Section 1.4
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Reference substance
• A IUCLID entity that collects chemical (scientific) identifiers on a particular chemical
• Purpose is to store the information once in the database, and link to it from any IUCLID document and section needed.
• Not related to a particular location; can be used to describe:
• The registered substance in section 1.1
• A constituent of the substance in section 1.2
• An impurity or additive of the substance in section 1.2
• A surface treatment agent of nanomaterials in section 1.2
• The assessed substance in the PBT assessment in section 2.3
• A component of the test material in endpoint study records in sections 4–9
• The identity of a transformation product in section 4.17, 4.18, 4.19, 5.1.1, 5.1.2, 5.1.3, 5.1.4, 5.2.2, 5.2.3, 5.4.1, 6.5, 9.3
• The identity of reaction products of an intermediate in section 3.5.3
• The component of an assessment entity in section 0.4
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• Use it for storing chemical and scientific identifiers; not regulatory information
• Linked from different places, exchanged by companies
• Important not to store information inside the reference substances that is specific to its IUCLID section, to the company, or to the registered substance i.e.:
• No description of “scope of registered substance”
• No company-specific manufacturing process
Reference substance
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• Pre-filled reference substances and a limited inventory can be searched and downloaded from the website.
• https://iuclid6.echa.europa.eu/web/iuclid/get-reference-substances
Reference substance
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Reference substance -
Creating a new reference substance
• A new reference substance can be created in IUCLID 6
1. In the IUCLID 6 home view, by right-clicking the reference substance icon
2. Inside the reference substance inventory:
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Reference substance – Chemical inventories
• The EC inventory is now called Chemical inventories
• Currently only EC inventory exists
• Each reference substance can only link to one inventory entry of each inventory type. E.g. cannot link to two EC numbers.
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Reference substance – Chemical inventories
• To link an EC inventory file to a reference substance, you search and assign:
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Section 1.1 - Identification
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Section 1.1: Identification
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Section 1.1: Identification
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Section 1.1: Identification- Submission checks
• A reference substance must be linked
• As a minimum, the IUPAC name must be given. If IUPAC name is not available, then a chemical name must be given in that field.
• EC number must be given if exists (JS identifier, inquiry)
• Molecular and structural information must be given; extent depends on type of substance
• Type of substance (mono-constituent, multi-constituent, UVCB) must be indicated
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Section 1.2 - Composition
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Section 1.2: Composition
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Section 1.2: Composition - Type of composition
• Picklist values:
• legal entity composition
• boundary composition (SIP)
• composition generated upon use
• other:
• Mandatory for all dossiers (BR)
• Legal entity composition is
selected by default for new or
migrated compositions
• At least one LE composition must exist
• LE compositions subject to TCC (Annex VI.2 requirements)
• Boundary composition has to provided by the LEAD registrant
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Section 1.2: Composition - Description of composition
• Existing field: 32.000 char
• Supporting attachments (e.g. flowchart) can be provided below
• Mandatory for UVCB substances -
it is the only place to report
registrant-specific process
description
• Free-text templates can be
loaded into the field to support
a meaningful process description
• ECHA verifies that a UVCB
manufacturing process description
has been given in this field
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Section 1.2: Composition - Justification for deviations
• Must be used to give justification
when deviating from substance
identity conventions:
– Mono-constituent substance• > 1 constituent
• < 80 % constituent
• > 20% impurity
– Multi-constituent substance• < 2 constituents
• > 80 % constituent
• > 10% impurity
– UVCB• 1 constituent
• ECHA verifies that a relevant justification has been given in this field.
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Section 1.2: Composition
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Full concentration range always required; except if reporting exactly 100% or 0%
Section 1.2: Composition
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• Mandatory to select a
value starting with
‘stabiliser…’
Section 1.2: Composition - Function (of additive)
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• UVCB manufacturing process must be given for each LE composition
• Any deviation from the conventions for identifying and naming a substance must be justified in the ‘Justification for deviations’ field of each LE composition
• Only one constituent for multi or UVCB
• More than one constituent for mono
• Deviation from 80-20% rules for mono-constituent and 80-10% rule for multi-constituent substances
• A full concentration range must be given for each constituent, additive, impurity
• The stabilising function of the additive must be indicated
Section 1.2: Composition – Submission checks
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Section 1.2: Composition – Remaining Submission checks
• At least one ‘legal entity composition of the substance’ must exist
• Degree of purity must be given (one value and unit)
• Each composition must have at least one constituent
• A reference substance must be linked to each constituent, impurity, additive
• Each reference substance must contain EC, CAS and/or IUPAC information
• Molecular and structural information must be given; extent depends on type of substance (well-defined vs. UVCB)
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Section 1.4 – Analytical information
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Analytical information
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Analytical information
Picklist fields support user in reporting
relevant information
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Analytical information
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• Mandatory to provide analytical results on at least one determination to quantify, and one determination to identify the substance.
• Each created row must be complete:
• Provide the ‘Purpose of analysis’ and ‘Analysis type’
• Provide either an attachment in the field ‘Attached methods/results’ OR explain why this analysis type was not used in the fields ‘Rationale for no results’ and ‘Justification’
Analytical information
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Analytical information
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Analytical information
• Optical activity reported through picklist field
• Possible to link the analytical information record to the relevant composition(s) in section 1.2
• Not mandatory to provide either
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Validation assistant (VA)
• It should always be used before submitting a dossier to ECHA.
• All failures in the ‘Submission checks’ tab should be corrected as they will lead to failures during submission.
• The VA also contains the ‘Quality checks’ tab with rules that warn against inconsistencies in the dossier. These warnings will not lead to failures during submission, but may lead to clarification needs later on in other regulatory processes. Recommended to fix them before submitting.
• Passing the VA does not automatically mean that the registration passes the technical completeness check.
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Validation assistant
Use the Validation Assistant on your substance dataset
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Validation assistant – an example showing potential failures and inconsistencies
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Manual verification
• ECHA performs a completeness check on each incoming registration to ensure that the required information is provided (Article 20 of the REACH Regulation).
• As of 21 June 2016, the automated completeness check is complemented with additional manual checks of certain elements of the registration dossier that cannot be checked automatically, to ascertain that all the information required by the legislation has been included.
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• ECHA performs the manual verification on both new registrations and updates of existing dossiers.
• Validation assistant cannot show the outcome of the manual checks as they are done by ECHA staff.
• The manual checks are integrated in the completeness check process.
• Detailed information on the areas of the manual verification is available and published on the ECHA website under Support -> Manuals: https://echa.europa.eu/manuals
Manual verification
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Support
• Dossier preparation manuals
– Available on ECHA website (Support >> Manuals)
– Integrated in IUCLID 6 help system (F1 key)
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Support
• If after consulting the manual and the document there are still questions, please contact ECHA using the following link: https://echa.europa.eu/contact
• ECHA also organised a webinar on the completeness check on 20 April 2017. The recording will be available on the webinar website. https://echa.europa.eu/support/training-material/webinars
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