REACH Registration Process

To minimize animal testing and data fee for each registrant, REACH encourages data sharing among all registrants by the joint submission of registration data to ECHA. The principle is “one substance, one registration”.

During joint submission process, the lead registrant or REACH consortium will do most of the work such as data collection, development of technical dossier and Chemical Safety Report (CSR), and submission of joint registration dossier to ECHA. Other co-registrants only need to pay the lead registrant or consortium a fee to refer to the joint registration dossier and then prepare the individual part of the registration dossier in IUCLID 5.

Registrants will have two options to complete registration as a member of joint submission: Purchase a letter of access or join REACH consortium. Both options allow registrants to refer to the joint registration dossier prepared by lead registrant or REACH consortium. Generally, a letter of access is cheaper because it does not grant ownership of data.

REACH Registration Process for Phase-in Substances

  1. After pre-registration, all pre-registrants of the same substance are put into one Substance Information Exchange Forum(SIEF), in which members exchange information and share data;
  2. SIEF facilitator conducts survey on registration intention, substance sameness and data availability;
  3. Lead registrant is elected by all SIEF members (in many cases, LR is a large company or a member of a consortium);
  4. Lead registrant collects data, prepares joint registration dossier (technical dossier and/or Chemical Safety Report) and submits the dossier to ECHA in REACH-IT;
  5. Co-registrants pay lead registrant a fee(buy a letter of access or join REACH consortium) to refer to the common part of registration dossier and receive the name of joint submission and a security token from lead registrant;
  6. Co-registrants confirm membership of joint submission in REACH-IT, complete the individual part of registration dossier in IUCLID 5 and submit it to ECHA;
  7. Co-registrants pay ECHA administrative fee and receive a registration number;

 

In rare cases, joint registration dossier might not include Chemical Safety Report or not cover certain uses. Member registrants need to prepare their own Chemical Safety Report correspondingly.

For more information about joint submission process (REACH-IT, LEO, IUCLID 5) and how to prepare the individual part of registration dossier in IUCLID 5, please click CIRS's presentation on joint submission process and reach registration dossier preparation[pdf, 2.4MB].

Please note: Phase-in substances are also called existing substances.

REACH Registration Process for New Chemical Substances

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

Our REACH Registration Services

CIRS's full-range REACH registration services will provide end-to-end solutions for REACH registration of both existing substances and new chemical substances. Theese services include:

  • SIEF/consortium communication;
  • 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;
  • Individual dossier preparation in IUCLID 5;or
  • 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, Opertations Manager, louise@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:

  • Ms. Louise Halpin, Europe Office
    Singleton House, Laurence Street, Drogheda, Co. Louth, Ireland
    Tel : +353 41 9806 916 | Fax : +353 41 9806 999
    Email: louise@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