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Assent Compliance - 2013 REACH Registrations

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

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

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  • 1. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931REACH – RegistRation 2013 is not the only RequiRement, aRe you Ready foR the next 2 yeaRs? assent compliance Krystal Noseworthy-BaKer phone: 613.882.1429 krystal.baker@assentcompliance.com custom solutions for compliance [ reach | rohs | cpsia | rsl | prop65 ]
  • 2. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 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 custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 3. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 AgENdA • Recent ECHA Releases • CLP Overview • Data Sharing – Rulings and Reports • Requirements • Registration Overview • Timelines • Requirements • Process • Timelines • FAQs • Process • Impacts • FAQs • Implementation Timelines • Impacts • Common Industry Practices • Authorisation Review • Q&A custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 4. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 REgISTRATION – RECENT ECHA RELEASES First Report Card was released July 1, 2011 • Examined the lessons and challenges encountered so far (3 years into REACH, 2 years into CLP). Dealt with everything from nanomateri- als to joint registration to IT tool support • Communication, feedback, process, comitology all need to improve response time, there are no issues with the quality of response simply how quickly the information is getting up and down the chain • Enforcement guidance and processes will hopefully be clarified and released Green MEP Satu Hassi (European Parliament Environment Committee liaison) and the ECHA • Discussion on SVHCs • Discussion on compliance checks and making dossiers better (= more time-consuming) custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 5. AS SENTCOM PLIANCEinfo@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931There are currently 4416 registrations with 20175 registration numbers having been granted (there were over 143 000 pre-registrations)Registration dossiers for intermediates are not up to the necessary standards http://echa.europa.eu/news/na/201105/na_11_21_intermidiates_en.asp • The ECHA screened over 400 dossiers and found the majority do not meet the conditions necessary to benefit from the reduced information requirements for intermediates • The ECHA is placing onus on the registrants to reassess and update as requiredcustom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 6. AS SENTCOM PLIANCEinfo@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.693107 Mar 2011 – Completeness checks completed by ECHA as required http://echa.europa.eu/news/na/201103/na_11_08_echa_meets_completeness_check_deadline_en.asp • 15366 dossiers relevant to the 2010 deadline were submitted in the 2 months leading up to the deadline • It is ECHA’s duty to undertake a completeness check on these within a three month period which ended on February 28th, 2011 – The deadline was met by the ECHA.On a separate REACH note:SDS Guidance was officially published September 7th, 2011custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 7. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 dATA SHARINg – RuLINgS ANd REPORTS Multiple Registrants, Same Substance • August 10th, 2011 http://echa.europa.eu/news/na/201108/na_11_33_same_substance_reg- istrants_20110810.asp • Companies have submitted registrations without taking part in a single Substance Information Exchange Forum (SIEF) custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 8. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 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. custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 9. AS SENTCOM PLIANCEinfo@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931• 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 num- ber of registrants so it is important to investigate this as soon as possible.custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 10. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 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 in- formation requirements increase however theses annexes also establish the rules for any adaptation from the information requirement custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 11. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931REACH – REgISTRATIONtimeline Registration Registration Registration > 1 tonne LOA Access > 1000 tonnes, TODAY Letter and >= 100 tonnes Registration OMRs, R50-53 SEptEmbER JunE 1, 2012 Reception of JunE 1, 2013 < 100 tonnes 21, 2011 Dec 1, 2010 Lead Dossier JunE 1, 2018 Collection, Completion Locate and verification appoint Only of Section 1.4 Entry of and entry Testing Representative of all remaining if required. UV data into necessary IR existing dossier. NMR dossier data. MS TCC Dossier HPLC Submission GC custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 12. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931REACH – REgISTRATIONprocessSubstance Review YES Gather Gather Dossier Active SIEF and Is there an active Gather Identify Data membership Instructions Gather Data as Consortium SEF 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 Sections 1 – 13 TCC Gather data as necessary Submit Dossier Complete Dossier TCC Submit Dossier custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 13. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 REACH – REgISTRATION faqs • What if there is no lead registrant? • What if I already have an Only Representative? • What happens if we do not meet the 2013 Deadline? • Once we have registered is there anything else we will need to worry about? custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 14. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 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 custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 15. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 CLASSIfICATION, LAbELINg + PACkAgINg (CLP) overview – classification • 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 custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 16. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 CLASSIfICATION, LAbELINg + PACkAgINg (CLP) overview – 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 custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 17. AS SENTCOM PLIANCEinfo@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931• 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• ORs have no role under CLP• Notification to match Registration• Harmonised classification published – Notification to be updated • 14 mar 2011 – http://echa.europa.eu/news/na/201103/a_11_10_rac_opinions_clh_20110314_en.asp • 15 June 2011 – http://echa.europa.eu/news/na/201106/a_11_27_rac_adopts_ten_scientific_opinions_en.aspcustom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 18. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931  CLP notification process Without testing time included, normally takes 2-4 weeks (Very Data Dependent) Have you completed notifications for Collection, OptImAL: Decide on Completion of hazardous substances verfication and Confirm Substance Completion TCC Notification Section 1.4 Testingand all substances under entry of all Identity already and Submission Submitter UV the scope of REACH? necessary existing entered of dossier (EU Entity) IR dossier data NMR MS HPLC GC custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 19. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 CLP timeline CLP Classification CLP Classification CLP Classification (Substances) TODAY CLP Classification Transition Transition Dec 1, 2010 SEptEmbER (Mixtures) (Substances) (Mixtures) 21, 2011 June 1, 2015 December 1, 2012 June 1, 2017 CLP Notifi cation January 3, 2011 custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 20. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 CLP faqs • My products are all mixtures, do my SDSs have to have CLP classification information on them? • I registered my substances before the 2010 deadline but I am not sure if the CLP information was included? • My substance is under the 1 tonne threshold for REACH so I did not notify for CLP, should I have any concerns? custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 21. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 CLP impacts • At this time, the primary impact is customs stoppages. • It is very obvious when substances do not meet the CLP requirements Example: Formaldehyde DSD Classification : Carc. Cat. 3; R40 – T; R23/24/25 – C; R34 – R43 Risk Phrases : + R23/24/25 : Toxic by inhalation, in contact with skin and if swallowed. : + R34 : Causes burns. : + R40 : Limited evidence of a carcinogenic effect. : + R43 : May cause sensitization by skin contact. Safety Phrases : + S1/2 : Keep locked up and out of the reach of children. : + S26 : In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. : + S36/37/39 : Wear suitable protective clothing, gloves and eye/face protection. : +  S45 : In case of accident or if you feel unwell, seek medical advice immediately (show the label where possible). : + S51 : Use only in well-ventilated areas. Symbol(s) and Indication(s) of Danger + T: continued... custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 22. AS SENTCOM PLIANCEinfo@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931(cont’d)Example: FormaldehydeDSDSpecific Concentration Limit(s) Concentration Classification C ≥25 % T; R23/24/25 5 % ≤ C < 25 % Xn; R20/21/22 C ≥25 % C; R34 5 % ≤ C < 25 % Xi; R36/37/38 C ≥ 0,2 % R43custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 23. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 CLP impacts (cont’d) CLp REguLATION (EC) NO 1272/2008 ANNEx VI TAbLE 3.1 classification labelling Hazard Class and Hazard Statement pictogram Signal Hazard Statement Category Code(s) Code(s) Word Code(s) Code(s) Carc. 2 H351 H351 Acute Tox. 3 * H331 GHS06 H331 Acute Tox. 3 * H311 GHS08 H311 Acute Tox. 3 * H301 GHS05 H301 Skin Corr. 1B H314 Dgr H314 Skin Sens. 1 H317 H317 SPECIfIC CONCENTRATION LIMITS ANd M fACTORS concentration C ≥25 % 5 % ≤ C < 25 % 5 % ≤ C < 25 % C ≥ 5 % C ≥ 0,2 % custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 24. AS SENTCOM PLIANCEinfo@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 PICTOgRAMSSkull & Crossbones Health Hazard Corrossioncustom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 25. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 REACH ANd CLP timeline review Questions & Answers on Regulation (EC) No 1272/2008 on classification, labeling and packaging of substances and mixtures: REACH Pre-registration First phase Second phase Third phase entry into period in deadline in deadline in deadline force December 1, 2010 June 1, 2013 June 1, 2018 June 1 to June 1, 2007 December 1, 2008 all new substances and substances and reach substances mixtures ≥ 1000 mixtures ≥ 100 tonnes substances and mixtures ≥ 1 tonne per year timeline and tonnes per year or of per year mixtures very high concern year 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 onwards classified, labelled and packaged under dsd. if clp is classified under both dsd and clp; substances applied in full as well, labelled and packaged under clp. classified, labelled and packaged under clp. clp no dsd labelling and timeline packaging. classified, labelled and packaged under dpd. if clp is applied in full as well, mixtures no dpd labelling and packaging. CLP entry into Obligation to Obligation to apply CLP to mixtures. Please note that for certain force; repeal of apply CLP to substances/mixtures in the 2012/2017 deadline for re-labelling and Annex I to DSD substances re-packaging applies January 20, 2009 December 1, 2010 June 1, 2015 custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 26. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 COMMON INduSTRy PRACTICES – REACH & CLP • Registration: Only Representative Nomination • Registration – Joint Dossier: REACH Centrum is a commonly used SIEF and Consortium administrative firm with established processes, contracts, and LoAs • CLp Classification: In-house chemical assessment based on defined CLP thresh- olds (within regulation) OR Third Party assessment based on testing results • CLp notification: Importer of record/manufacturer provides information to Third party for completion and submission of dossier on their behalf custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 27. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 AuTHORISATION REVIEw • The Authorisation process – starts with the identification of substances of very high concern (SVHC) by Member State Competent Authorities or the European Chemicals Agency (on behalf of the European Commission) by preparing a dossier in accordance with Annex XV. • Decisions on prioritisation of these SVHCs and the subsequent release of the final list of substances subject to authorisation is decided by the Commission. • Each Authorisation: • identifies the substance, • provides it’s “properties of very high concern”, • makes clear both the Sunset Date and the Application Date • includes the review period and the exempted uses or categories of uses, if applicable custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 28. AS SENTCOM PLIANCEinfo@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931• SVHC Candidate List substances will most likely ALL eventually be on the authorisation list• Applicable to imported substances on their own or in preparations. • Substances being an integral part of articles are NOT subject to authorisation• Applicable to all substances manufactured in the European Unioncustom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 29. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 AuTHORISATION REVIEw (CONT’d) • Authorisation Applications (dossiers) are created in IUCLID (same as REACH Registration dossiers and CLP notification dossiers) • They are NOT submitted in REACH-IT, they use a webform via the ECHA website • They include a CSR , an alternatives analysis, a socio-economic analy- sis and a substitution plan • Applications must be submitted 18 MONTHS before the sunset date • Application creation should start at least 30 MONTHS (2.5 YEARS) before the sunset date • You will see on the next slide that the sunset dates are in 2014 and 2015: » Application deadlines starting February 2013 – February 2014 » Application creation process should start February 2012 – February 2013 • What is the alternative? • REDESIGN custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 30. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 REACH – AuTHORISATION current authorisation list substance included in annex, sunset date 4,4’ – Diaminodiphenylmethane (MDA) In Annex XIV – Sunset Date Aug 21, 2014 Dibutyl phthalate (DBP) In Annex XIV – Sunset Date Feb 21, 2015 Benzyl butyl phthalate (BBP) In Annex XIV – Sunset Date Feb 21, 2015 Bis (2-ethyl(hexyl)phthalate) (DEHP) In Annex XIV – Sunset Date Feb 21, 2015 5-tert-butyl-2,4,6-trinitro-m-xylene (musk In Annex XIV – Sunset Date Aug 21, 2014 xylene) Hexabromocyclododecane (HBCDD)and In Annex XIV – Sunset Date Aug 21, 2015 all major diastereoisomers identified: custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 31. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 RECOMMENdEd fOR AuTHORISATION recommended for inclusion dec 17, 2010 substances Diarsenic pentaoxide Diarsenic trioxide Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins) 2,4-Dinitrotoluene *Recommendation for inclusion June 1, 2009 Diisobutyl phthalate (DIBP) Lead chromate Lead chromate molybdate sulphate red (C.I. Lead sulfochromate yellow (C.I.Pigment Yellow Pigment Red104) 34) Tris(2-chloroethyl)phosphate custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 32. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 dRAfT RECOMMENdATION fOR AuTHORISATION comment deadline sept 14th substances Cobalt dichloride Sodium dichromate Ammonium dichromate Chromic acid Oligomers of chromic acid and dichromic Dichromic acid acid Chromium trioxide Cobalt(II) carbonate Cobalt(II) diacetate Cobalt(II) dinitrate Cobalt(II) sulphate Potassium chromate Potassium dichromate Sodium chromate Trichloroethylene custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]
  • 33. AS SENTCOM PLIANCE info@assentsvhc.com w w w. a s s e n t s v h c . c o m tel: 866.964.6931 QuESTIONS? Please submit your questions in writing using the Q&A tool along the top menu tool bar. Any questions not addressed during the Q&A portion of this webinar will be addressed in private correspondence after the webinar. custom solutions for compliancy [ reach | rohs | cpsia | rsl | prop65 ]

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