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

REACH Seminar 29th July’ 08, Chennai

Role of the “Only Representative” (OR)

within REACH:

European Union’s New Chemical Policy

Dr. Shruti Ralegaonkar[[email protected]]


Non-EU Manufacturer’s Options

o Use Importer as a channel for registration and other REACH compliance issues

o Appoint an Only Representative to act on its behalf for registration and other REACH compliance issues


Only Representative: Roles & Responsibilities

o Liaison between ECHA and non-EU manufacturer

o Pre-registration of substance

o Communication and documentation

o Register on behalf of non-EU manufacturer

o Maintain and update registered information

o Communicate Safety Data Sheets for

Downstream Users


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


Qualities of an Only Representative

o Typically independent and specialized serviceo Small organization with network of technical

support organizationso In-depth Understanding of REACH Regulation and

its processo Understanding of IUCLID 5 softwareo Understanding of the business culture of the non-

EU manufacturer


o Legally constituted in Swedeno Extensive REACH – knowledge and capacity o Core team of 5 professionals o Specializes in REACH’s application/ implications

on non-EU manufacturero Extended Team: Our partners in REACH

ComplianceSweco Environment (Sweden) Adelphi Consulting (Germany) B-Lands Consulting (France) REACH Support (India)

Sustainability Support Services (Europe) AB: Only Representative appointed by CHEMEXCIL


o Only OR service providing a local presence in India

o IUCLID 5 and REACH IT – understanding and capacity to use; train others

o OR service related infrastructureLegal Council – Nordic Law Insurer of our OR services –

Länsforsarkering Financial and Administrative – SET

SSS (Europe) AB: Highlights


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)


Pre-registration Methodology

oSubstance information submitted by industries toCHEMEXCIL’s REACH teamoCHEMEXCIL team enters info into IUCLID Plug-inoThis data is then transferred to REACH Support for DataValidation (CMR 1 & 2 [> 1 tonne) and R50/53 (> 100 tonnes)]

oIf any queries exist, the company is contacted to establish

correct substance identityoQueries clarified by interaction with companyoCHEMEXCIL raises invoice after data validation is doneoIndustry pays the requisite OR service charges to Council

oUpon receipt of payment, OR does the Pre-registrationoPre-registration report forwarded to company by the OR

through CHEMEXCIL


NameSubmission

NumberPre-registration number Status Tonnage band

Deadline date

1,5-dihydroxy-4-nitro-8-(phenylamino)anthraquinone

DT143933-20 05-2114105841-59-0000 CompletedBetween 1 to 10 tonnes/year

31/05/2018

1,8-dihydroxy-4-nitro-5-(phenylamino)anthraquinone

QW143935-97 05-2114105843-55-0000 CompletedBetween 1 to 10 tonnes/year

31/05/2018

4-[(4-ethoxyphenyl)amino] -N,N-dimethyl-3-nitrobenzenesulphonamide

RF143936-28 05-2114105844-53-0000 CompletedBetween 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


CHEMEXCIL’s REACH Score (as on 28th July’ 08)

o Substance Information Received 708

o Substances Pre-registered84

o No. of companies who have submitted info 78

o No. of companies whose Pre-registration18

is complete

o Substances validated (For CMR/ R 50/53) 406

o Substances ready for Pre-registration 152

o Queries being solved by REACH Support 10-12

through e-mail & telephone (Daily average)


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)


Suggested Roadmap for Complete REACH Compliance

(Contd.)oPreparation of the Registration Dossiers in IUCLID

5

o Joint submission of technical data within a SIEF

o Individual submission of industry details

oRegistration with the ECHA as per applicable

deadlines


www.chemexcil-reachhelp.com


Issue of the Non-EU TradersOptions 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).


Documents

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