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REACH Registration as Lead Registrant

If a substance is of strategic importance to your company and no other lead registrant or REACH consortium is in place, or if you hold valid data for the REACH registration of the substance, you should consider registering the substance as lead registrant. As a lead registrant, you will be required to prepare a complete registration dossier (technical dossier + chemical safety report) in IUCLID 5 and submit it to ECHA.

The initial cost of being a lead registrant could be daunting considering the high cost of GLP testing(up to 2 million Euros) and dossier preparation. Several companies could form a REACH consortium to pool financial resources. The initial cost could be compensated by offering letter of access to other registrants.

REACH Registration: What information is required?

A registration dossier consists of two parts: Technical Dossier and Chemical Safety Report.

1. Technical Dossier (> 1 ton per year)

  • Identity of manufacturer/importer;
  • Identity, volume and identified uses of substance;
  • Classification and labeling ;
  • Study report and robust study summaries according to Annex VII to X (physiochemical, toxicological, eco-toxicological properties, etc);
  • Testing proposal;
  • Statement whether tests have been carried out on vertebrate animals;

 

2. Chemical Safety Report (> 10 ton per year)

  • Human hazard assessment, physicochemical properties assessment, environmental hazard assessment and PBT/vPvB assessment;
  • Exposure Scenario is required if classified as dangerous or PBT/vPvB;
    • operational conditions and risk management measures for each use;
    • exposure estimation;

Our REACH Registration Services

Our full-range REACH registration services will provide end-to-end solutions to REACH registration. If you are considering registration of a substance as lead registrant, please don't hesitate to contact us for free advice. We will evaluate the total costs of being a lead registrant. We can also help you form consortium or SIEF leading team(SLT) with other companies.

We provide a full range of registration services in one package to help you finish registration as lead registrant. Theese services include:

  • SIEF/consortium management;
  • Data gap analysis, literature search, GLP testing, QSAR and read-cross;
  • Testing proposal;
  • Full registration dossier preparation including technical dossier and chemical safety report;
  • Safety data sheets;

 

We have helped hundreds of non-EU firms and EU companies acquire over 180 REACH registration numbers up to date. The reasons to choose us include:

  • Extensive substance specific registration experience;
  • Broad communications with SIEF/Consortium;
  • No hourly rates and hidden charges;
  • Success guaranteed;
  • Free regulatory updates and free consultations;

 

Please don't hesitate to contact us if you would like to find out whether you need to do reach registration or not and how much it might cost you. Our initial consultations are free.

About the Expert

Louise Halpin, Operations Manager, service@cirs-reach.com

Expertise: REACH only representative, REACH registration dossier preparation (IUCLID 5), REACH SDS, chemical classification and labelling in according to CLP, C&L notification, GHS.

Louise Halpin graduated from Trinity College Dublin with an honors degree in medicinal chemistry. Prior to joining CIRS, she was a regulatory affairs consultant for an international consultancy company. She was responsible for preparing relevant dossiers for submission to the EU, under Directives 91/414/EEC and 98/8/EEC. As the chief Environmental fate specialist, her work focused on conducting various environmental risk assessments, liaising with clients regarding the product under which registration was sought, liaising with relevant personnel within regulatory bodies in the EU member states and attending meetings in the Irish Department of Agriculture.

We offer free consultation services on cost estimation. If you would like to find out how much it might cost to register your substances, please consult:

  • Europe Office
    Unit 1 Ardee Business Park, Hale Street, Ardee, Co. Louth, Ireland
    Tel : +353 41 9806 916 | Fax : +353 41 9806 999
    Email: service@cirs-reach.com
  • Ms. Alice Qian, China Office
    11F Building 1, Dongguan Hi-Tech Park, 1288 Chunbo Road, Binjiang District, Hangzhou 310052, China
    Tel: +86-571 8720 6555 | Fax: +86-571 8720 6533
    Email: info@cirs-reach.com