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New Chemical Substance Notification in EU - REACH Inquiry

REACH regulation has replaced the old framework(67/548/EEC) of notification of new substances (NONS) in the EU. A notifier can claim their REACH registration number from the Agency (via the REACH IT system) for free for substances that have been notified.

Under REACH, new chemical registration would require an inquiry dossier submitted to ECHA. This applies to companies who would like to put a new substance on EU market for the first time and companies who decide to register an existing substance without pre-registration.

After an inquiry has been submitted, ECHA then will indicate what data is available for sharing, and which information requirements would require new studies involving vertebrate animals. ECHA will also inform potential registrants of the contact details of previous registrants and other potential registrants.

After inquiry, potential registrant needs to buy letter of access from other registrants, prepare another registration dossier and submit it to ECHA.

Please click here[pdf,99kB] to view a complete inquiry process illustrated by Prevention du risque chimique of France.

REACH Registration Process: Inquiry + Registration

  • Inquiry dossier must be firstly submitted to ECHA to see what data is required, what data is available and if there are other potential registrants;
  • Potential registrant negotiates the cost of data with previous registrant or other potential registrants and reaches data sharing agreement (via letter of access);
  • Potential registrant collects the rest of data required (usually by GLP testing), prepares registration dossier and submits it to ECHA;

Inquiry Dossier

  • the identity of the company;
  • the identity of the substance (Name, EC, CAS, analytical data, etc);
  • which information requirements would require new studies involving vertebrate animals to be carried out ;
  • which information requirements would require other new studies to be carried out.

Registration Dossier

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

1. Technical Dossier

  • 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;

Cost Estimation and Duration

The total reach registration cost depends on the tonnage band and the hazard properties of the substance (data cost could be very expensive). Based on our experience, the total cost of registering a new substance (1-10t per year) is between 6,000 Euros and 25,000 Euros. The inquiry process takes 1-2 months and the whole registration process might take up to 12 months.

Our REACH Registration Services: Inquiry + Registration

Our full-range REACH registration services will provide end-to-end solutions for REACH registration at competitive prices. Theese services include:

  • Inquiry dossier preparation and submission;
  • Data gap analysis, literature search, GLP testing, QSAR and read-cross, testing proposal;
  • Data cost negotiation and purchase of letter of access;
  • Full IUCLD 5 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