Safety data sheet information - ECHA - Europa

Safety data sheet information
Dissemination & Confidentiality
Claims
06 September 2012
Martin ALBERT
ECHA

Content of presentation
• Background information
• Timelines
• General Information on SDS Claims
• Detailed description of new SDS Claims
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SDS info & Dissemination
Background Information /
Timelines
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Background on dissemination of SDS info
• According to Article 119(2) of REACH, ECHA shall
disseminate certain information unless claimed
confidential
• Article 119(2)d: information, other than that listed in paragraph
1, contained in the safety data sheet;
• Initially only uses and uses advised against were
disseminated under Article 119(2)(d)
• Following a re-interpretation of the scope of Article
119(2)(d), more information from registration dossiers
will be disseminated as of November 2012
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Timelines for dissemination of SDS info
For previously submitted dossiers:
• Action needed: Review your dossier; edit and insert
claims if appropriate, and resubmit
• Submit an update by 31 October 2012
• Dissemination of SDS info (not claimed confidential)
starts November 2012
Assistance:
• Dissemination and Fee calculation plug-in
• Data Submission Manuals 15 and 16
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SDS information to be disseminated
• Registration number
• Registrant name
• Life cycle description and uses advised against
information
• Result of the PBT (Persistent, Bioaccumulative and
Toxic chemicals) and vPvB (very Persistent and very
Bioaccumulative) assessment
• Indication of whether a chemical safety assessment
(CSA) was performed
• Exposure scenario elements (not before 2014)
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SDS info & Dissemination
General Information on SDS Claims
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General principles
• Claim on SDS will be invoiced once for all elements.
(Independent from number of SDS items claimed)
• ECHA requires an individual justification for each item
claimed confidential
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ECHA invoices confidentiality claims
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ECHA invoices confidentiality claims
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Updated version of Fee calculation plug-in
• Same logic as for REACH-IT invoicing
• Indicates the places of chargeable confidentiality
claims
• Because all the information is not available in the
dossier (i.e. classification from the lead dossier),
some checkboxes have been implemented:
• SDS indicator
• PBT/vPvB indicator
• Hazardous substance indicator
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Confidentiality claim charges
• Confidentiality claims on SDS info will in general only be
charged if the substance requires a safety data sheet:
• Criteria listed in REACH Art. 31,
• Not applicable for On-Site Isolated Intermediates (OSII)
• If no SDS required, the confidentiality claim indicates
that the registrant does not volunteer the publication of
the information (no fee will be charged)
• Some items for the SDS claims are only charged if a
CSR is required:
• Section 2.3: PBT assessment (endpoint summary and / or endpoint
study record(s))
• Section 13: CSA performed
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Criteria when SDS is required
a) substance is hazardous; or
• Hazardous definition amended by CLP 58(2). As submitted by
registrant in Section 2.1 Classification and Labelling in the
IUCLID dossier
b) substance is PBT or vPvB; or
• As defined by the registrant in Section 2.3 endpoint summary in
the IUCLID dossier
c) substance is included in the candidate list
• Substance EC number, CAS number or IUPAC name are
compared with those on the candidate list.
Not applicable for “On-Site Isolated Intermediates” (OSII)
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SDS info & Dissemination
Detailed description of SDS claims
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Section 1.1: Company name
• For manufacturers and importers, the registrant name will be
disseminated unless it is claimed confidential
• The name of the OR will be disseminated unless it is claimed
confidential, or unless suppliers (importers) are listed in section 1.7
whose identity is not claimed confidential
• ORs having indicated suppliers (importers) need to attach
permission from the suppliers for dissemination of their
information
• The name of the Third Party Representative will not be disseminated
• Legal entity name and full address will be disseminated
• Information is taken from REACH-IT except for the supplier details
that come from section 1.7 in IUCLID
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Section 1.1: Company name
INVOICED
INVOICED
REMEMBER: In case you are an OR and you indicate suppliers (importers),
be sure to attach an agreement from the supplier for dissemination of their information
Alternative solution in case you do not have an agreement with your suppliers:
1) Put a flag on Section 1.1 (chargeable) no name is disseminated
2) Put a flag on Section 1.7 (not chargeable) name of OR is disseminated
Different repeatable blocks can be created in Section 1.7
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Section 1.1 Contact person for the SDS
• In IUCLID 5.4, a
new type of
contact person is
introduced:
competent person
responsible for the
safety data sheet
• Information will be
disseminated
unless claimed
confidential:
• Organisation name
• Phone number
• Address
• In case claimed
confidential, no fee
will be charged
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Company information to be disseminated
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Dossier header & section 1.3:
Registration number
• Registration number in full (13 digits) will be
disseminated unless claimed confidential
• If the registrant name has been claimed confidential
but the registration number has not, the last four
digits will be hidden
• Possibility to claim confidentiality on registration
number in two places:
• Dossier header Section 1.3
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Section 2.3 endpoint summary:
PBT assessment outcome
• The information on the PBT/vPvB assessment outcome
will be disseminated, unless it is claimed confidential
• Endpoint summary in section 2.3:
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Section 2.3 endpoint study records:
Results on PBT assessment
• The information on the PBT/vPvB assessment results
will be disseminated, unless it is claimed confidential
• The reference substance attached to an endpoint study
record in this section and the remark for the assessed
substance will not be disseminated
• Endpoint study records in section 2.3
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Section 3.5: Life Cycle description
• Identified uses (section 3.5) in IUCLID 5.4 has been renamed Life
Cycle description and has been restructured and expanded
• The uses entered in the tables in section 3.5 are currently
disseminated, unless claimed confidential
• The same information will be disseminated with IUCLID 5.4. The new
tables in these sections (for example Formulation) will be
disseminated in a similar way
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Section 3.6: Uses advised against
• The uses advised against entered in section 3.6 are
currently disseminated, unless claimed confidential
• The same information will be disseminated with
IUCLID 5.4. The new tables in these sections
(for example Formulation) will be disseminated in a
similar way
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Section 3.7.1 endpoint study records:
Exposure scenarios and local assessment
• Information from this section will only be disseminated
when TCC will be applied for this section (not before 2014)
• Registrants are encouraged to complete this section
comprehensively,
• since IUCLID 5.4 is providing the opportunity to store this information in
a structured and harmonised format in one single database, and
• to avoid having to rewrite this section in case of a later update of their
dossier
• For the moment ECHA recommends not to flag this section
as confidential
• A further announcement on the specific fields to be
disseminated will be published well in advance
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Section 3.7.3: Generic exposure potential
• The fields in section
3.7.3 were
previously part of
section 3.5 on the
uses,
• The information will
automatically be
migrated in IUCLID 5.4
• Section 3.7.3 on
Generic exposure
potential will be
disseminated in full,
unless it is claimed
confidential
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Section 13: Assessment report
• An indication of whether a CSA was performed will be
disseminated, unless claimed confidential.
• Whether an assessment report of the type ‘REACH Chemical safety report (CSR)’
was included in the dossier, and the existence or absence of an attachment.
• SDS fee will be charged in case there is a flag in the section 13
endpoint study record with a document type ‘REACH Chemical
Safety Report (CSR)’
• Note that the CSR
itself will not be
disseminated
ä
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Conclusions
• Use the latest version of the dissemination plugin to
check your dossier before submission
• Resubmit your dossier before 31 October 2012 if new
claims on the safety data sheet are needed
• ORs who have listed suppliers need to attach their
permission for dissemination
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Thank you
ALBERT, Martin
Martin.Albert@echa.europa.eu