REACH Registration 2013 - Assent Compliance Webinar

AS SENTCOM PLIANCE
info@assenTcompliance.com w w w. a s s e n T c o m p l i a n c e . c o m Tel: 613.290.8044

REACH
Registration 2013
Assent Compliance

Krystal Noseworthy-Baker
phone: 613.882.1429
krystal.baker@assentcompliance.com

C u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]

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Introduction to Assent Compliance

Assent Compliance
• Consulting
• Global Requirements
• Compliance Strategies
• Regulatory Interpretations and Impacts
• IT
• Cloud Computing
• Application Design
• Operations
• Program Implementation
• Data Management

C u s t o m s o l u t i o n s f o r c o m p l i a n c y [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]

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Agenda


• Recent ECHA Releases
• Registration Overview
• Requirements
• Timelines
• Process
• FAQs
• Impacts
• Other Concerns
• CLP
• Common Industry Practices
• Q&A

C u s t o m s o l u t i o n s f o r c o m p l i a n c y [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]

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 Recent ECHA Releases
Late pre-registration of substances to be
registered in 2013 closing soon (May 25th, 2012)
• To benefit from the extended deadlines for registering phase-in substances under the REACH Regulation:
• Registrants have to/had to pre-register their phase-in substances.
• The opportunity to late pre-register phase-in substances due to be registered by the 2013
registration deadline was 31 May 2012.

• All substances with phase-in status that are produced or imported into the EU in quantities
above 100 tonnes per year must be registered on 31 May 2013 at the latest.
• To benefit from the staggered registration deadlines, phase-in substances that are manufac-
tured or imported above the one-tonne threshold need either to have been pre-registered
by the original pre-registration deadline in 2008 or “late” pre-registered within six months
of the first manufacture or import of the substance.
»» The possibility to “late” pre-register substances to be registered by 31 May 2013
ends one year before the deadline, i.e. on 31 May 2012.
»» The possibility to “late” pre-register substances to be registered by 31 May 2018
ends one year before the deadline, i.e. on 31 May 2017.

C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]

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• After 31 May 2012 (NOW):
»» For substances due to be registered by May 31 2013 that are not pre-registered:
»» Companies need to submit an inquiry to ECHA and register the substance
before manufacturing/importing can take place.

• Substances that need to be registered by the 2018 REACH registration deadline can still be
“late” pre-registered within 6 months of the first manufacturing or importing.
»» 2018 Deadline Substances = Substances that are for the first time manufactured or
imported in quantities between 1-100 tonnes per year (and not classified as CMRs)


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 Recent ECHA Releases
Registration, evaluation and authorisation discussed
at ECHA’s Stakeholders’ Day (May 23rd, 2012)
• During the Stakeholders’ Day, ECHA will draw the attention of registrants to the timely prepara-
tion and quality of their REACH registration dossiers.
• As of the date of preparing this presentation, a report on the day had not been released
• The next registration deadline for substances produced or imported in the EU in quantities at or
above 100 tonnes per year is 31 May 2013. Based on the experience of evaluating the registra-
tions from the 2010 deadline, ECHA urges all registrants to step up their dossier preparation
efforts now and to pay special attention to the quality of their dossiers.
• During the event, ECHA will inform industry about its new compliance check strategy which
complements its current evaluation activities.
• The new strategy aims to systematically target dossier elements that are immediately rel-
evant for the safe use of the substance.
• Rather than evaluating the full dossier content at once, a part of the compliance checks
will be addressing for example targeted endpoints which are related to the Persistent,
Bioaccumulative and Toxic (PBT) or Carcinogenic, Mutagenic or Toxic to reproduction
(CMR) status of a substance.


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• The ECHA will start checking those parts of registration dossiers which have been identi-
fied based on this concern-driven approach.
»» As a consequence, registrants who have submitted non-compliant dossiers
may receive multiple decisions from ECHA for a single dossier.
»» In addition to these targeted compliance checks, a significant part of the overall
compliance checks will still be addressing the full dossier content in order to
assess the overall compliance of the dossier and its safety assessments.

• ECHA will also introduce the substance evaluation process that started in March 2012
and describe how it is functionally interlinked with other evaluation and regulatory risk
management processes.
• ECHA will also highlight an example chemical safety report (CSR) that it has developed to
support companies in complying with their obligations under REACH. The example gives
tips for developing a good quality CSR and advice on how to avoid common deficiencies
that have been identified by ECHA.


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 REACH Registration 2013
Overview
• Applies to substances produced or imported into the EU at ≥100 tonnes per year per manufacturer
or importer.
• Greater number of substances is expected to be registered in 2013 than in 2010.
• The total data requirements for ≥100 tonne substances are less than those for the ≥1000 tonne
substances.
• Unfortunately because these substances have smaller tonnages, they are less widely used which
means it is more than possible that less data will be available to fulfill the REACH dossier
information requirements.
• This may mean there is increased use of alternative methods for filling data gaps, (read-across,
Quantitative Structure Activity Relationships (QSARs), new testing or the creation of testing
plans.)
• The biggest help to dossier completion are SIEFs (Substance Information Exchange Forums) and
Consortiums – Letters of access to the dossiers and information they have already gathered are
essential for proper completion of data requirements. The cost of letters of access is determined
by the number of registrants so it is important to investigate this as soon as possible.


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Requirements
• Information Requirements are established in Annex VII, VIII and IX of the REACH Regulation:
Standard Information Requirements for Substances Manufactured or Imported in Quantities of
1 Tonne or More, 10 Tonnes or More and 100 Tonnes or More

• Sections 4-7 of the IUCLID Dossier are where the informational increase is concentrated

• As you move from one tonnage level to another, the registration dossier information require-
ments increase however theses annexes also establish the rules for any adaptation from the infor-
mation requirement


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Timeline

Registration
Registration
Late Late >1 tonne <100
Registration LOA Access >100 tonnes
Pre-Registration Pre-Registration tonnes
>1000 tonnes, Letter and TODAY June 1, 2013
CMRs, R50-53 Reception of Deadline JUNE 7, 2012 Deadline June 1, 2018
Dec 1, 2010 Lead Dossier May 31, 2012 Submit May 31, 2017 Submit
may 31, 2013
may 31, 2018

Collection,
Locate and verification
appoint Only and entry
Representative of all Completion
if required. necessary of Section 1.4 Entry of
existing Testing remaining
dossier data. UV data into
IR dossier.
NMR
MS TCC Dossier
HPLC Submission
GC


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Process

Substance Review

YES Gather Gather Dossier
Active SIEF and Is there an active Gather Identify Data
membership Instructions Gather Data as
Consortium SIEF or Corsortium? membership data Gaps
process. Gather and Substance necessary
Investigation and costs Sections 1 & 3
LoA. Dataset
NO

Identify Data Complete Dossier
Data Gathering Gaps Gather data as
Sections 1 – 13 necessary
TCC
Complete Dossier

Submit Dossier
TCC

Submit Dossier


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 REACH Registration
FAQs
What if there is no lead registrant?
• Communicate within SIEF
• Discuss Data Realities
• Appoint an OR
OR could accept Lead Registration on your behalf

What if I already have an Only Representative?
• Only Representative transfer is not a complicated process if required

What happens if we do not meet the 2013 Deadline?
• Non-compliance.
• Cannot continue import until registration is complete.

Once we have registered is there anything else we will need to worry about?
• CLP, communications from SIEF, communication of registration number (SDS, etc.)


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 IMPACTS
Registration 2013, REACH Compliance
• Customs Stoppages
• Delivery Delays or Rejections
• New Product Launch delays
• Fines
• Imprisonment
• Loss of business
• REACH compliance is quickly becoming a contractual obligation and if the obligation
cannot be met then potential customers move on


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 Other Concerns for Substance and
Mixture Producers/Importers
Classification, Labeling and Packaging (CLP)
• Regulation (EC) No 1272/2008
• GHS (Global Harmonised System) Based
• Impacts the classification of substances, mixtures, including:
• Safety Data Sheets
• Packaging
• Labelling

• CLP Classification Deadlines:
• Substances: 1 December 2010
»» If already on the market before 1 December 2010 1 December 2012

• Mixtures: 1 June 2015
»» If already on the market before 1 June 2015 1 June 2017

• CLP SDSs
• Deadlines for SDSs (AND LABELS), same as classification deadlines


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 Other Concerns for Substance and
Mixture Producers/Importers
Classification, Labeling and Packaging (CLP) -
Notification
• CLP Notification Scope:
• Substances subject to registration under REACH
»» Unless already registered (during 2010 registration) with the CLP classification included
• Substances classified as hazardous under CLP and placed on market
»» IRRESPECTIVE OF TONNAGE
• Substances classified as hazardous under CLP and in a mixture above concentration limits
(Annex I CLP, or in DPD) which results in mixture being classified as hazardous and the
mixture is placed on the market

• CLP Notification Deadlines:
• Substances on market 1 December 2010: January 3rd, 2011
• Substances on market after 1 December 2010: 1 month from date of placement on market


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 • ORs have no role under CLP
• UPDATE: ECHA accepts group notification to the Classification and Labelling Inventory
for companies who are not themselves manufacturers or importers (May 3rd, 2012)

ORs will be able to submit notifications on behalf of a group of manufacturers or importers
»» ECHA has announced it will accept notifications to the classification and labelling
(C&L) inventory from groups other than manufacturers and importers.
»» Only Representatives will now be able to submit notifications on behalf of non-EU
companies.
• Previously, companies had to import small quantities of substance to qualify as
importers in order to make the notification.
»» Conditions:
• The submitting company will need to be able to document that it has been
mandated to act in this capacity
• The manufacturers or importers in the group acknowledge that they remain
fully responsible for fulfilling their obligations associated with the notification.

• Notification to match Registration
• Harmonised classification published - Notification to be updated


REACH Registration 2013 - Assent Compliance Webinar

REACH Registration 2013 - Assent Compliance Webinar

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