An EU proposal to restrict certain chemicals in tattoo inks and permanent make-up (PMU) under REACH is "not fit for purpose", Anec, the European consumer voice in standardisation, has said.
The proposal – jointly submitted by Echa, Denmark, Italy and Norway – suggests restricting around 4,000 substances.
In the EU's consultation on the process, which closed on 20 June, NGOs and member states posed questions about the scope and how concentration limits of certain substances compare with other European legislation.
The proposal comprises two restriction options, which take into account several points, including:
- reasonable assumptions about not placing under the skin chemicals that are deemed ‘unsafe’ in cosmetics products applied on the skin;
- carcinogenic, mutagenic and reprotoxic (CMR) classified substances not permitted to be marketed or supplied to the public should not be used in tattoo inks and PMU; and
- chemicals with hazard profiles indicating potential sensitisation issues should not be applied under the skin or in the eye.
In its comments, Belgium said the proposal "lacks ambition" and called for "strict bans" on EDCs and classified carcinogenic, mutagenic and reprotoxic (CMR) substances in tattoo inks and PMU.
While CMR categories 1A, 1B and 2 – which are banned from use in cosmetics – are included in the restriction proposal, those suspected of causing cancer via the inhalation route are excluded. But Belgium says classifications "based on all exposure routes should be taken into consideration, to exclude use of substances of concern".
And it said it has identified chemicals classified as CMRs that are not captured in the list of banned substances in the present restriction dossier.
In its comments, Finland questioned why the proposal does not address the potential exposure of tattoo artists from the possible release of aerosols from tattoo guns or when preparing ink from the dry powder form.
NGOs the Health and Environment Alliance (HEAL) and the European Environmental Bureau (EEB) support the inclusion of workers in the scope. There is "so much overlap" between tattoo artists and recipients in evaluating substances that it would be "shortsighted" to exclude workers who use the same chemicals every day, they said.
Meanwhile, HEAL and the EEB raised concerns that the proposal includes many derogations for substances with no alternative and cited pigment green 7 and pigment blue.
Proposed concentration limits of certain chemicals have also raised concerns, especially in relation to controls arising from other legislation.
Belgium, HEAL and EEB said they do not agree with allowing CMR substances up to the generic concentration limit as defined under CLP, because the OECD test basis for deriving these is "not adequate for intradermal use of these substances".
In its comments, Anec suggested introducing practical enforcement limits of 10ppm (0.001%) for category 1A and 1B and 100ppm (0.01%) for category 2 CMRs.
Anec suggested introducing practical enforcement limits of 10ppm (0.001%) for category 1A and 1B and 100ppm (0.01%) for category 2 CMRs
Skin sensitisers are also in the scope of the proposed restriction. The Swedish Chemicals Agency, Kemi, said it is concerned that generic (and specific) concentration limits in the CLP Regulation for these "may not be relevant and that the intended level of protection of the restriction may not be reached".
And Belgium said it does not agree with permitting classified skin sensitisers in tattoo ink, and that allowing these at 0.1% w/w is "inconsistent with the current knowledge that induction and elicitation appear at extremely low" levels.
It is also inconsistent, it added, with current provisions under the cosmetics Regulation – with obligations for labelling above 0.001% for leave-on products – as well as in detergent products (obligation of labelling from 0.01%).
And colourants, listed in Annex IV of the cosmetics Regulation, have not been assessed for intradermal application and therefore "can be not considered as safe" for use in tattoo inks, it added.
Meanwhile, Anec said REACH is not the best framework for regulating the substances because positive lists, which should be a "key long-term goal", cannot be established under the Regulation.
A "better choice", it added, would be to include them in the cosmetics Regulation or to establish a separate legal framework following similar principles.
It also noted that there are "many cases" of industry self-classifying substances. The proposed restriction should also cover these, "where 50% or more of the notifiers have self-classified the substances indicating these hazard classes".