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AS SENTCOM PLIANCEinfo@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...
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: 61...
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...
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...
AS SENTCOM PLIANCEinfo@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...
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...
AS SENTCOM PLIANCEinfo@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...
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...
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...
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 ...
AS SENTCOM PLIANCE                   info@assenTcompliance.com                         w w w. a s s e n T c o m p l i a n ...
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...
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...
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...
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...
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...
REACH Registration 2013 - Assent Compliance Webinar
REACH Registration 2013 - Assent Compliance Webinar
REACH Registration 2013 - Assent Compliance Webinar
REACH Registration 2013 - Assent Compliance Webinar
REACH Registration 2013 - Assent Compliance Webinar
REACH Registration 2013 - Assent Compliance Webinar
REACH Registration 2013 - Assent Compliance Webinar
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REACH Registration 2013 - Assent Compliance Webinar

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Assent Compliance hosts regular webinars which cover compliance for REACH, RoHS , CLP, Conflict Minerals and many other environmental regulations. To view the web cast online visit www.assentcompliance.com

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Transcript of "REACH Registration 2013 - Assent Compliance Webinar"

  1. 1. AS SENTCOM PLIANCEinfo@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.comC 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 ]
  2. 2. 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 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 ]
  3. 3. 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 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 ]
  4. 4. 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 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 ]
  5. 5. AS SENTCOM PLIANCEinfo@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 • 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)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 ]
  6. 6. 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 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. 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 ]
  7. 7. AS SENTCOM PLIANCEinfo@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 • 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.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 ]
  8. 8. 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 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. 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 ]
  9. 9. 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 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 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 ]
  10. 10. 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 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, 2013CMRs, 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 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 ]
  11. 11. 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 ProcessSubstance 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 DossierData Gathering Gaps Gather data as Sections 1 – 13 necessary TCC Complete Dossier Submit Dossier TCC Submit Dossier 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 ]
  12. 12. 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 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.) 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 ]
  13. 13. 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 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 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 ]
  14. 14. 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 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 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 ]
  15. 15. 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 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 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 ]
  16. 16. 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 • 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 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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