About REACH Registration

Most registrants of a substance under REACH will have to jointly submit one dataset for the substance, the so-called “joint submission” (JS) which is prepared and submitted by the Lead Registrant (LR).

However, each company will have to submit their own registration individually and will have a range of additional individual obligations which are not covered by the joint submission. Many companies may not have the in-house expertise or resources to deal with tasks such as co-registrant communication or dossier preparation in IUCLID. Other companies may need advice on the exact requirements placed on them in order to achieve a successful registration.

Doruksistem supports joint registrants with their registration obligations through tailored advice and technical assistance.

Our registration services are underpinned by the technical, regulatory, managerial and legal expertise of the company’s consultants and affiliates.

Our registration services offering includes:

Who Must Register Under REACH?

REACH registration is the obligation of EU-established manufacturers and importers that manufacture a substance in the EU, or import it into the EU, on its own or in a mixture, in quantities of 1 tonne or more per year (“no data, no market”). Under certain conditions, registration is also required for substances intentionally released from articles.

Non-EU manufacturers cannot register directly; instead, they can appoint an EU-based Only Representative to register on their behalf, in which case EU importers are regarded as downstream users. Downstream users have no registration obligation, but they should communicate their uses to their suppliers and apply the measures in the Safety Data Sheet.

What Happened to Pre-registration?

Pre-registration took place between 1 June and 1 December 2008 and gave “phase-in” (existing) substances staggered registration deadlines based on tonnage and hazard. The transition was completed in three phases: 30 November 2010, 31 May 2013 and 31 May 2018.

Since 1 June 2018, the phase-in / non-phase-in distinction has no practical relevance: pre-registration no longer gives any rights, and every substance within the scope of REACH must be registered before it is placed on the market.

How Does REACH Registration Work?

Inquiry: The potential registrant submits an inquiry to ECHA to find out whether the substance has already been registered and which data can be shared.
Data sharing and joint submission: Under the “one substance, one registration” principle, registrants of the same substance share data and submit jointly. The lead registrant prepares the joint dossier; other registrants usually obtain access to the data by purchasing a letter of access (LoA).
Dossier preparation: The registration dossier is prepared in IUCLID format.
Submission: The dossier is submitted to ECHA via REACH-IT.
Checks, fee and registration number: ECHA checks the dossier for technical completeness; once the fee is paid and the check is passed, a registration number is assigned.

Which Information Is Required?

The information required in the registration dossier increases with the annual tonnage:

1–10 t/y: Annex VII information
10–100 t/y: Annexes VII and VIII
100–1000 t/y: Annexes VII–IX
≥ 1000 t/y: Annexes VII–X

For registrations of 10 tonnes or more per year, a Chemical Safety Report (CSR) is also required; if the substance is hazardous or PBT/vPvB, exposure scenarios are included. Tests under Annexes IX and X require a testing proposal to ECHA first.

Obligations After Registration

Dossier updates: Changes such as tonnage band, composition, classification, uses or new information require a dossier update. Implementing Regulation (EU) 2020/1435 sets update deadlines of 3 to 12 months, depending on the type of change.
ECHA evaluation: ECHA carries out compliance checks and may request missing information.
Supply chain communication: Safety Data Sheets and, where relevant, exposure scenarios must be provided to recipients and kept up to date.
Candidate List and restrictions: Developments on the SVHC Candidate List, authorisation (Annex XIV) and restrictions (Annex XVII) should be monitored regularly.

Official guidance is available on ECHA’s REACH registration page. Contact our experts for your registration strategy and dossier updates.

REACH Registration Timeline (2007–2018)

Date	Milestone
1 June 2007	REACH entered into force.
1 June 2008	ECHA started operations; pre-registration began.
1 December 2008	Pre-registration ended.
30 November 2010 (Phase 1)	Registration deadline: substances ≥ 1000 t/y; CMR substances (Category 1A/1B) ≥ 1 t/y; substances very toxic to aquatic organisms ≥ 100 t/y (R50/53; Aquatic Acute 1 and Chronic 1 under CLP).
31 May 2013 (Phase 2)	Registration deadline: substances ≥ 100 t/y.
31 May 2018 (Phase 3)	Registration deadline: substances ≥ 1 t/y. The transition period ended.
Since 1 June 2018	All substances within the scope of REACH must be registered before being placed on the market.

Doruksistem – Services

REACH Registration Services