Overview: comparison of the dispute procedures for pre-registrants and inquirers

 

The procedure is slightly different depending on whether your substance is subject to pre-registration or inquiry. If your substance is subject to pre-registration, the procedure is based on Article 30(3) of REACH. If your substance is subject to inquiry, the procedure is based on Articles 27(5) and (6) of REACH.

 

  Pre-registration/SIEF Inquiry

What does that mean?

Pre-registration was possible until 1 December 2008 if you manufactured or imported the substance before that time.

Late pre-registrations can be done until 31 May 2017, if you have started to manufacture or import in quantities between one and 100 tonnes a year.

After pre-registration, you become a member of a substance information exchange forum (SIEF) where all discussions on substance sameness, data sharing and joint submission take place.

If you intend to start manufacturing or importing a substance more than one tonne a year and can no longer late pre-register, you are subject to inquiry.

When you submit an inquiry to ECHA, you will be put in contact with the existing registrants of the same substance. You will then need to discuss sharing data and submitting jointly with them.

Admissibility check

Up to 15 working days (can be extended if ECHA needs to request further information from the potential registrant)

Deadline for the other party to provide documentary evidence

10 working days (if the other party does not provide documentary evidence within 10 working days, ECHA will assess the dispute based only on the documentation submitted by the claimant)

Deadline to issue decision after having received evidence from both parties

2 months

1 month

Outcome/content of decision

ECHA either issues a decision granting the potential registrant permission to refer to the requested studies and/or providing a token to access the joint submission, or requests both parties to continue their negotiations.

Note 1: Even after ECHA issues a decision granting permission to refer, parties are still encouraged to reach a voluntary agreement.

Note 2: If ECHA issues a decision requesting the parties to continue negotiations, and the parties cannot come to an agreement in their negotiations, the potential registrant can submit another dispute covering their subsequent efforts.

Scope of permission to refer

Only vertebrate studies subject to the negotiations.

All studies subject to the negotiations.

Access to joint submission

Token to access the joint submission in REACH-IT (More information on Joint submission web page)

Payment?

If ECHA grants permission to refer and/or access to the joint submission, ECHA will not request a proof of payment. However, the other party may refer the matter to the competent national courts for adequate compensation.

If ECHA intends to grant permission to refer and/or access to the joint submission, first a request for proof of payment is sent along with the draft decision.

Once the proof of payment is received, ECHA issues the final decision.

Note: ECHA has no legal competence to assess whether or not this compensation is adequate. This is under the exclusive competence of national courts. However, ECHA advises that this payment reflects at least the elements agreed during the negotiations.

Legal remedies

All dispute decisions are appealable at the ECHA Board of Appeal within three months.

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