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REACH Seminar 29 th July 08, Chennai Role of the Only Representative (OR) within REACH: European Unions New Chemical Policy Dr. Shruti Ralegaonkar

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Presentation on theme: "REACH Seminar 29 th July 08, Chennai Role of the Only Representative (OR) within REACH: European Unions New Chemical Policy Dr. Shruti Ralegaonkar"— Presentation transcript:

1 REACH Seminar 29 th July 08, Chennai Role of the Only Representative (OR) within REACH: European Unions New Chemical Policy Dr. Shruti Ralegaonkar [shruti@reach-support.com]

2 REACH Seminar 29 th July 08, Chennai Non-EU Manufacturers Options oUse Importer as a channel for registration and other REACH compliance issues oAppoint an Only Representative to act on its behalf for registration and other REACH compliance issues

3 REACH Seminar 29 th July 08, Chennai Only Representative: Roles & Responsibilities oLiaison between ECHA and non-EU manufacturer oPre-registration of substance oCommunication and documentation oRegister on behalf of non-EU manufacturer oMaintain and update registered information oCommunicate Safety Data Sheets for Downstream Users

4 REACH Seminar 29 th July 08, Chennai Specific Tasks of the OR oPre-registration with the ECHA oCommunication in the Supply Chain (with non-EU manufacturers & EU importers) oNotification of substances of very high concern (SVHC) oUpdates to the ECHA (if any) oOther obligations resulting from Authorization & Restrictions oTranslation of SDS in the language of the EU Member States (upon request) oCo-operation with new OR in case of change of OR

5 REACH Seminar 29 th July 08, Chennai Qualities of an Only Representative oTypically independent and specialized service oSmall organization with network of technical support organizations oIn-depth Understanding of REACH Regulation and its process oUnderstanding of IUCLID 5 software oUnderstanding of the business culture of the non-EU manufacturer

6 REACH Seminar 29 th July 08, Chennai oLegally constituted in Sweden oExtensive REACH – knowledge and capacity oCore team of 5 professionals oSpecializes in REACHs application/ implications on non-EU manufacturer oExtended Team: Our partners in REACH Compliance Sweco Environment (Sweden) Adelphi Consulting (Germany) B-Lands Consulting (France) REACH Support (India) Sustainability Support Services (Europe) AB: Only Representative appointed by CHEMEXCIL

7 REACH Seminar 29 th July 08, Chennai oOnly OR service providing a local presence in India oIUCLID 5 and REACH IT – understanding and capacity to use; train others oOR service related infrastructure Legal Council – Nordic Law Insurer of our OR services – Länsforsarkering Financial and Administrative – SET SSS (Europe) AB: Highlights

8 REACH Seminar 29 th July 08, Chennai SSS (Europe) AB: OR Service Package Preparation of Pre-Registration dossier after data validation (substance identity & substances in articles) Submission of the Pre-Registration dossier of the substance using REACH-IT system (IUCLID 5 plug in) Identifying the respective Substance Information Exchange Forum (SIEF) within which the ECHA has grouped the substances Will represent as the communication & liaison center for the substances; specifically the communication from ECHA and SIEF leader and other SIEF members Will offer services to represent the substance in the Substance Information Exchange Forum (SIEF)

9 REACH Seminar 29 th July 08, Chennai Pre-registration Methodology oSubstance information submitted by industries to CHEMEXCILs REACH team oCHEMEXCIL team enters info into IUCLID Plug-in oThis data is then transferred to REACH Support for Data Validation (CMR 1 & 2 [> 1 tonne) and R50/53 (> 100 tonnes)] oIf any queries exist, the company is contacted to establish correct substance identity oQueries clarified by interaction with company oCHEMEXCIL raises invoice after data validation is done oIndustry pays the requisite OR service charges to Council oUpon receipt of payment, OR does the Pre-registration oPre-registration report forwarded to company by the OR through CHEMEXCIL

10 REACH Seminar 29 th July 08, Chennai Name Submission Number Pre-registration numberStatusTonnage band Deadline date 1,5-dihydroxy-4-nitro-8- (phenylamino)anthraquinone DT143933-2005-2114105841-59-0000Completed Between 1 to 10 tonnes/year 31/05/2018 1,8-dihydroxy-4-nitro-5- (phenylamino)anthraquinone QW143935-9705-2114105843-55-0000Completed Between 1 to 10 tonnes/year 31/05/2018 4-[(4-ethoxyphenyl)amino] - N,N-dimethyl-3- nitrobenzenesulphonamide RF143936-2805-2114105844-53-0000Completed Between 1 to 10 tonnes/year 31/05/2018 Company specific details on the REACH IT portal can be accessed through the following Web link: https://reach-it.echa.europa.eu/reach/public/login.faces

11 REACH Seminar 29 th July 08, Chennai CHEMEXCILs REACH Score (as on 28 th July 08) oSubstance Information Received708 oSubstances Pre-registered84 oNo. of companies who have submitted info78 oNo. of companies whose Pre-registration18 is complete oSubstances validated (For CMR/ R 50/53)406 oSubstances ready for Pre-registration152 oQueries being solved by REACH Support10-12 through e-mail & telephone (Daily average)

12 REACH Seminar 29 th July 08, Chennai Suggested Roadmap for Complete REACH Compliance oPre-registration through the OR oSIEF Formation (Pre-SIEF page of every substance) oSubstance Inventory to know Data Gaps oOR participation in the SIEF (Online or physical meetings) oData Trading (Buying data after compensating data owner or selling data that the industry owns) oTesting to fill in the data gaps (GLP certified laboratories)

13 REACH Seminar 29 th July 08, Chennai Suggested Roadmap for Complete REACH Compliance (Contd.) oPreparation of the Registration Dossiers in IUCLID 5 oJoint submission of technical data within a SIEF oIndividual submission of industry details oRegistration with the ECHA as per applicable deadlines

14 REACH Seminar 29 th July 08, Chennai www.chemexcil-reachhelp.com

15 REACH Seminar 29 th July 08, Chennai Issue of the Non-EU Traders Options available 1. The traders can request their importers to do their Pre- registration (not preferred). 2. They appoint an independent importer to fulfill their REACH obligations (OR can also be appointed as the importer). (Terms and conditions will have to be carefully framed as this OR will also invite the attention of other European agencies like Customs, Excise, etc). 3. They request their suppliers to do Pre-registration and probably help them financially (The can use their Pre- registration number). 4.They present themselves as manufacturers (not legal).

16 REACH Seminar 29 th July 08, Chennai


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