Registry of restriction intentions until outcome
Registry of restriction intentions until outcome
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 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 | Commission decided |
Date of intention | 23-kol-2016 |
Expected date of submission | 06-lis-2017 |
Withdrawal date | |
Reason for withdrawal | |
Start of Call for Evidence consultation | 31-kol-2016 |
Deadline for comments on the Call for Evidence | 31-lis-2016 |
Start of second Call for Evidence consultation | |
Deadline for comments on the second Call for Evidence | |
Start of third Call for Evidence consultation | |
Deadline for comments on the third Call for Evidence | |
Restriction report (and annexes) | |
Information note on restriction report | |
Start of Annex XV report consultation | 20-pro-2017 |
1st deadline for comments on Annex XV report | 16-velj-2018 |
Final deadline for comments on Annex XV report | 20-lip-2018 |
Comments on Annex XV report | |
Opinion of RAC (and minority positions) and Forum Enforceability Advice (as of September 2023) | |
Draft opinion of SEAC | |
RAC & SEAC (draft) Background document (and annexes) | |
Start of SEAC draft opinion consultation | 12-pro-2018 |
Deadline for comments on SEAC draft opinion | 11-velj-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 | 13-sij-2021 |
First published | 27-velj-2018 |