Registration

To qualify for extended registration deadlines, companies were required to pre-register with ECHA before December 1st, 2008. Companies who missed the deadline do not qualify for extended registration deadlines and must submit an Inquiry to ECHA and proceed with an Immediate Registration. However, companies who first breached the one tonne threshold after December 1st, 2008 can still benefit from extended registration deadlines.

For information on late pre-registration see REACH Representative Services.

Types of Dossiers

Dosser Type Description Timing
Lead Complex dossier, typically within consortia

>1,000t (Dec 2010),            >100t (June 2013),                 > 1t (June 2018)
Joint Purchase Letter of Access (LOA) to associate with Lead Dossier As Above
Inquiry Possible new substance, change tonnage band 12 months before registration event
NONS Upgrade to existing or tonnage update New infomation is available or there is a tonnage change
PPORD Temporary relaxation from "some" REACH for R&D Submit and wait 2 weeks for tacit approval












Inquiry Process

Inquiry involves the submission of an Inquiry Dossier detailing the substance in question. This dossier is used by ECHA to establish if the substance has been registered already. If the substance has been registered already, then a letter of access can be purchased from the original registrant(s) to gain access to their technical dossier; if not, then a technical dossier will have to be created.

Dossier Modus Service

Following Inquiry, a registration dossier is completed and submitted along with a letter of access or technical dossier.

  • Phase 1: “Data Gathering and Assessment”; includes collecting substance identification and existing data, assessing the quality and applicability of the data and identify the gaps based on the dossier requirements. Collectively this information is used to develop a substance and client tailored “Gap Assessment”.

 

  • Phase 2: “Study Plan Development & Execution” includes resolution of data testing options, in depth evaluation of existing intrinsic data and includes the exploration of alternate testing methods – such as QSAR, data modelling etc. H2 Compliance phase 2 services focus on optimizing the testing requirements and registration deadlines.

 

  • Phase 3: Full Dossier Build including Test Plan Completion”. For all dossiers this stage includes engagement and selection of the Contract Research Organisation (CRO), completion of the Test Plan with reliable study monitoring and final dossier build. Based on a sound testing strategy. H2 Compliance interacts and negotiates on the clients behalf with top CRO’s. For dossiers at the 10 ton registration level, this stage also includes completion and development of a Hazard Assessment, Exposure Scenarios and Risk Characterisation. This stage ends with a dossier ready for submission.

 

  • Phase 4: This represents the last phase of the Dossier Modus service and involves the dossier registration submission with receipt of dossier acceptance. Typically this would represent completion of the dossier project and project completion.100% of our dossiers are accepted the first time they are submitted.

Your Obligations if you have missed the deadline

  • Submit an Inquiry to ECHA and make an immediate registration
  • Suspend the sale/manufacture of your product in Europe

Additional Services

  • Chemical Safety Assessment (CSA) and Exposure Scenario (ES) Development
  • Scientific Assistance with GHS Classification & Labelling
  • Chemical Safety Report (CSR) Write Up
  • Budgeting & Business Impact Analysis
  • Downstream User Communications
  • Safety Data Sheet Creation and Translation

For clarification on your situation or for more information regarding our services contact us by phone, email or using our Online Enquiry Form.

 

 

Air Products:

“The company and its partners bring a wealth of experience to this technical area and have a high quality of communication and project management. Communications are efficient and with regard to the confidential nature of our relationships. Air Products has found the relationship with H2 Compliance to be strong and we are happy to recommend them”

Petr K, Prague

 

Managing REACH & CLP: The Essential Guide to 2013

This workshop is essential for regulatory managers, importers & manufacturers to understand more about registering your substances in 2013.

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