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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.

Substances in tattoo inks and permanent make up

EC / List no: - CAS no: -
CLP Annex VI Index number
Further substance information
The starting point for the scope of the assessment is the list of substances restricted in the Cosmetics Products Regulation (EC) N° 1223/2009 as well as substances with harmonised classification as CMR, skin sensitiser/irritant/corrosive, and eye irritant/damaging. This scope also covers the substances in the Council of Europe Resolution (ResAP(2008)1) on requirements and criteria for the safety of tattoos and permanent make-up (https://wcd.coe.int/ViewDoc.jsp?p=&Ref=ResAP(2008)1&Language=lanEnglish&Ver=original&direct=true). ECHA and its partner Member States submitting the dossier (Denmark, Italy, and Norway) analysed the risks to human health of the substances used in tattoo inks and permanent make-up. Germany also significantly contributed to the dossier preparation.
Submitter(s)
ECHA
Denmark
Italy
Norway
Details on the scope of restriction
Restricting the placing on the market of certain chemicals in tattoo inks and permanent make-up.
Reason for restriction
The Commission has asked ECHA to assess the risk of chemicals in tattoo inks and permanent make-up, the relevant socio-economic impacts and the need for European Union-wide action beyond any national measures already in place by preparing an Annex XV dossier for restriction.
Remarks
The primary concern is human health risks for the general population. Risks not related to chemicals (e.g. hygiene concerns as well as other provisions, e.g., notification, warnings and complete ingredient labelling of tattoo inks) can continue to be regulated at the Member State level.
Status
Opinions adopted
Date of intention
23/08/2016
Expected date of submission
06/10/2017
Withdrawal date
Reason for withdrawal
Start of Call for Evidence public consultation
31/08/2016
Deadline for comments on the Call for Evidence
31/10/2016
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
20/12/2017
1st deadline for comments on Annex XV report
16/02/2018
Final deadline for comments on Annex XV report
20/06/2018
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
12/12/2018
Deadline for comments on SEAC draft opinion
11/02/2019
Comments on SEAC draft opinion
Compiled RAC and SEAC opinion (and minority positions)
Final background document (and annexes)
Adopted restriction/Commission communication
Latest update
08/07/2019

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