ink-1602896_1920.jpg

Chemicals (REACH)

A solid, highly experienced team focused on helping you meet your compliance deadline. You're in safe hands. A solid REACH dossier will enable you to put your substance on the market serenely. Your product is your priority, you are ours. During REACH Phase 1, 2 & 3 CEHTRA provided high quality technical and regulatory support and obtained extensive experience which can be a real asset to industry faced with the challenge of managing, completing and updating dossiers.

Moreover, by implementing Regulation (EU) 2020/1435 of 9 October 2020, the European Commission has now clarified when companies need to update their REACH registration dossiers. Click here to read more about how CEHTRA experts can assist you with REACH registration dossier updates.

Meet our experts

Mathieu ROLLAND

Head of REACH

mathieu.rolland@cehtra.com

Aurelie SEVESTRE-HERBELET

Senior Toxicologist

aurelie.sevestre@cehtra.com

Brigitte CASENAVE

Senior Chemist

brigitte.casenave@cehtra.com

Key Services

Dossier compilation & update

Lead registrant and co-registrant dossiers testing strategy

SIEF

Management

Consortium and SIEF communication, administrative and financial management of LoA

Only Representative

Representation of non-EU companies through our Only-Representative (OR) Legal Entity and UK-REACH

Supply-chain management 

Obligations as EU importer, manufacturer or Downstream-User (DU), notifications to ECHA

  • CEHTRA's consultants have been involved in the preparation of hundreds of REACH registration dossiers, acting on behalf of either the Lead Registrant or a coregistrant.

  • Industrials have successfully experienced CEHTRA and they continue for reviewing their product portfolio and strategy for REACH registration of substances, adapting testing strategies, expert regulatory and scientific advices.

REACH dossier registration updates

  • Implementing Regulation (EU) 2020/1435 of 9 October 2020, the European Commission has now clarified when companies need to update their REACH registration dossiers.

  • The requirement to update ‘without undue delay’ is in most cases specified as three months and, in more complex cases, up to 12 months.

  • Additionally, Cefic, through its multi-annual Action Plan, provides a framework for REACH registrants to evaluate the safety data in a stepwise manner.

IUCLID

Migration

Dossier Review

Lead Registration dossier update

Co-registration dossier update

Full update for

IUCLID 5 dossiers and

TCC passing for dossiers  submitted in older versions of IUCLID 6

Listing vulnerabilities and corrective actions

and expert advice to tackle them

a) Boundary composition including all

SIEF information

b) Outcomes associated to new studies

c) CSR with CHESAR

a) New UVCB qualities

b) New impurity profile

c) Impact for C&L

d) Tonnage update

We have indeed a large amount of experience in the update process:

 

i) IUCLID Migration Services

  • Only by using the Technical Completeness Check (TCC) tool in the latest version of IUCLID (6.5.1.2) can you ensure your submission will pass the first submission processing steps in REACH IT.

  • IUCLID 5.6 and newer files can be imported directly into the latest version of IUCLID (6.5.1.2) however they will most likely fail the latest Technical Completeness Check (TCC) and therefore need updating. Any IUCLID files older that 5.6 will not import into the latest IUCLID directly and would need to be updated in a stepwise process.

  • If you need to make submissions to the UK competent authority after Brexit you will also need to pass the latest TCC check.

  • Our team has good experience with IUCLID migration services. If you have any questions, write to one of our experts or simply drop your query in the chat window below and one of our experts will get back to you.

 

ii) Joint Submission Services

CEHTRA experts accompany:

 

a) Companies to update their dossier within or without the CEFIC Action Plan

b) Lead Registrants for preparing the dossier updates and associated costs taking other SIEF members into consideration.

c) Co-registrants when supply-chain and/or composition has been modified.

 

Value-added services

Cost-sharing and data-sharing

UVCB registration

Alternative testing strategies

Expert advice

Study monitoring

PRIMO tool to optimize management and follow-up of data

Downloads

7-ink WEBP Chemicals.webp

Key Contacts

Mathieu ROLLAND

Head of REACH

mathieu.rolland@cehtra.com

Aurelie SEVESTRE-HERBELET

Senior Toxicologist

aurelie.sevestre@cehtra.com

Brigitte CASANAVE

Senior Phyiso-Chemist

brigitte.casanave@cehtra.com