REACH Registration as Lead Registrant

Joint Registration and Lead Registrant

Each registrant is obliged to submit a registration dossier for each of his substances. In cases where the same substance is manufactured or imported or intended to be manufactured or imported by more than one company, all the registrants are obliged to be part of the same joint submission for that substance. The joint submission obligation applies for both the registration of phase-in substances and for that of non-phase-in substances.

Registrants are required to jointly submit information on the intrinsic properties of the substance (studies and testing proposals, if any) and its classification and labelling. Registrants may decide to jointly submit the guidance on safe use of the substance, the chemical safety report (CSR) and an indication of what information submitted for the CSR has been reviewed by an assessor.

The information that needs to be submitted jointly is submitted by one lead registrant on behalf of the other registrants. Other information needs to be submitted by all registrants individually.

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 6 and submit it to ECHA.

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 Lead Registrant 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 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. These 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 800 REACH registration numbers and acting as lead registrant for more than 100 substances 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.

Contact:

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 41 687 1874 | Fax : +353 41 9806 999

Email: service@hfoushi.com