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Registry of restriction intentions until outcome

The registry of restriction intentions until outcome lists the intentions and Annex XV restriction proposals received by ECHA.

A restriction proposal may be prepared by a Member State or by ECHA at the request of the Commission or on its own initiative for substances in the Authorisation List. It is a legal requirement for a Member State to notify ECHA of its intention to prepare a restriction dossier. The advance notice enables interested parties to plan and prepare for commenting later on.

Interested parties can follow the progress of a proposal through the restriction process, from the notification of the intention to the adoption of the final opinions by the Committee for Risk Assessment (RAC) and the Committee for Socio-economic Analysis (SEAC), and the adoption of the restriction by the European Commission.

Stakeholders are encouraged to submit any relevant information to the dossier submitters during the preparation of the restriction proposal and during the public consultations. Information to motivate any exemptions to the scope described in the intention is particularly useful to receive in the preparatory phase of the dossier.

Perfluorooctanoic acid and its salts

EC / List no: - CAS no: -
CLP Annex VI Index number
Further substance information
Submitter(s)
ECHA
Details on the scope of restriction
A derogation for the import and use in pharmaceutical products for the treatment of pulmonar diseases the restriction in entry 68 of Annex XVII: Perfluorooctanoic acid (PFOA), its salts and related substances.
Reason for restriction
This use was not identified during the processing of the PFOA restriction, and the Commission requested ECHA to review the derogation request of AstraZeneca.
Remarks
Status
Opinion development
Date of intention
16/05/2018
Expected date of submission
20/06/2018
Withdrawal date
Reason for withdrawal
Start of Call for Evidence public consultation
Deadline for comments on the Call for Evidence
Start of second Call for Evidence public consultation
Deadline for comments on the second Call for Evidence
Start of third Call for Evidence public consultation
Deadline for comments on the third Call for Evidence
Restriction report (and annexes)
Information note on restriction report
Start of Annex XV report public consultation
1st deadline for comments on Annex XV report
Final deadline for comments on Annex XV report
Comments on Annex XV report
Opinion of RAC (and minority positions)
Draft opinion of SEAC
RAC & SEAC (draft) Background document (and annexes)
Start of SEAC draft opinion public consultation
Deadline for comments on SEAC draft opinion
Comments on SEAC draft opinion
Compiled RAC and SEAC opinion (and minority positions)
Final background document (and annexes)
Adopted restriction/Commission communication
Latest update
10/01/2019

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