Proposed Group Standard UPDATE PAPER
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Proposed Group Standard For tattoo and permanent makeup substances SEPTEMBER 2011 UPDATE PAPER 2 Proposed Tattoo and Permanent Makeup Substances Group Standard (ERMA200781) Table of Contents 1. Introduction .................................................................................................................................. 3 2. The notification process ............................................................................................................. 3 3. The submissions ......................................................................................................................... 3 4. Revision of the proposed group standard ................................................................................ 4 4.1. Revision of the scope of the group standard ...................................................................... 4 4.2. Removal of schedules 3, 4 and 5 ........................................................................................ 4 5. Conclusions and recommendations ......................................................................................... 5 5.1. Best international practices and standards ......................................................................... 6 5.2. Appropriate controls ............................................................................................................ 6 5.3. Efficiency and effectiveness ................................................................................................ 6 5.4. Similar nature, type, circumstance of use ........................................................................... 6 5.5. Conclusion ........................................................................................................................... 7 Appendix A: Consultation Document .................................................................................................. 8 Appendix B: Parties Notified ................................................................................................................ 9 Appendix C: Summary of Submissions ............................................................................................ 13 Appendix D: Tattoo and Permanent Makeup Substances Group Standard .................................. 14 September 2011 3 Proposed Tattoo and Permanent Makeup Substances Group Standard (ERMA200781) 1. Introduction There has been increasing concern in recent years about the potential adverse health effects of tattooing, including allergic reactions to some pigments and potential long term health effects. In light of these concerns and, as the Cosmetic Products Group Standard was revised in 2010 to remove tattoo and permanent make-up (PMU) substances as of 31 October 2011, the EPA has proposed that a new group standard for approval of these substances be issued. 2. The notification process ERMA New Zealand1 publicly notified the proposal to issue a Tattoo and Permanent Makeup Substances Group Standard in June 2011 in the following manner: 1. Posting on the ERMA New Zealand website; and 2. Emailing relevant Government Agencies, industry associations and other interested parties (detailed in Appendix B). All interested parties were given an opportunity to make submissions. Submissions closed on 20 July 2011. 3. The submissions The following parties made submissions in response to the notification of the proposal: Auckland Regional Public Health Service; Te Toi Ora – Public Health Service; Janet Connochie; Ministry of Health New Zealand (MoH); Blackrose Tattoo and Hiviz Tattoo; The NZ Association of Registered Beauty Therapists Incorporated; and The NZ Tattoo Association. A summary of submissions is attached in Appendix C of this document, and is intended to provide a synopsis of the issues raised by submitters. Submissions ranged from general expressions of support to more technical analyses of the conditions of the group standard. No submissions in opposition to the proposed group standard were received. 1 The Environmental Protection Authority (EPA) took over the HSNO Act functions from ERMA New Zealand on 1 July 2011. September 2011 4 Proposed Tattoo and Permanent Makeup Substances Group Standard (ERMA200781) 4. Revision of the proposed group standard The proposed group standard has been revised from the draft standard released for public consultation. These revisions address: Submissions received and further advice and information received form industry; Simplification of information in the group standard, reflecting revision to the scope (see 4.1 below); Removal of contaminant limits from the standard (Schedules 3, 4 and 5). These limits will be published as guidance to the group standard; and Correction of minor technical errors in the document released for consultation. We consider these changes to be minor in effect. Parties who submitted on the original consultation, and other industry groups and enforcement agencies will not be adversely affected by the amendments. Therefore, there is no need for further consultation. 4.1. Revision of the scope of the group standard Substances triggering flammable classifications have been removed from the scope of the group standard based on new information which shows that flammable inks are not used. Whilst flammable substances are used within the tattoo industry, HSNO approval for these substances is given under existing group standards, and supplication within this group standard is unnecessary. 4.2. Removal of schedules 3, 4 and 5 The original group standard was based on the Council of Europe Committee of Ministers resolution, Res AP (2008)1, on the requirements and criteria for the safety of tattoos and permanent makeup. This resolution provides guidelines for the establishment of national legislation in member countries for the regulation of substances used in tattoos and PMU. The key features of Res AP (2008)1 are that it: prohibits the use in tattoos and PMU of substances that contain or release certain aromatic amines; prohibits the use in tattoos and PMU of certain colouring agents; prohibits the use in tattoos and PMU of substances banned from use in cosmetics under the EU Cosmetics Directive76/768/EEC; sets maximum permissible concentrations of certain impurities in tattoos and PMU. The EPA originally proposed to adopt a similar approach to developing a group standard, with a “negative list” of substances that should not be used in tattoos and PMU. In developing the proposed group standard, the EPA sought to allow the continued use of these substances while providing an acceptable level of protection for the environment and the health and safety of people and communities. The draft group standard released for consultation proposed not to give an approval for September 2011 5 Proposed Tattoo and Permanent Makeup Substances Group Standard (ERMA200781) substances containing certain hazardous components (these were the schedules 3, 4 and 5 in the original draft). However, the EPA considers that it is more appropriate to allow these substances to be imported or manufactured in New Zealand, but to provide explicit guidance on the presence of components in these substances. This guidance will be relevant to all substances used in tattooing, not just those imported or manufactured under this group standard approval. This guidance also provides the opportunity to address other types of risks, such as the transmission of infectious disease, providing a more holistic and convenient source of information for the industry. Further consideration has also been given to the matters set out in Part 2 of the Act - specifically the need to recognise and provide for the maintenance and enhancement of the capacity of people and communities to provide for their own economic, social and cultural wellbeing and for the reasonably foreseeable needs of future generations. It is well understood that tattooing forms part of the social and cultural wellbeing of many communities. By allowing the import and manufacture of these substances, and providing guidance on their use as tattoo and PMU substances, people would then be able to make the choice for themselves. It is considered that guidelines setting out which substances are, and which are not safe, may be a more appropriate means of recognising and providing for these matters. 5. Conclusions and recommendations According to s 96C(1), before issuing a group standard for these substances the EPA must: (1) consider best international practices and standards for the safe management of hazardous substances and products (s 96C(1)(f)); and (2) consider the types of controls appropriate for the group in accordance with sections 77, 77A and 77B (s 96B(2)); and (3) be satisfied that issuing....group standards is a more efficient and effective way of managing the risks of all the hazardous substances in the identified group than the approval process under Part 5 (s 96C(1)(a)). (4) Be satisfied that all the hazardous substances in the identified group have a similar nature, are of a similar type, or have similar circumstances of use, such that the risks of the group of hazardous substances can be effectively managed by 1 set of conditions. September 2011 6 Proposed Tattoo and Permanent Makeup Substances Group Standard (ERMA200781) 5.1. Best international practices and standards Allowing the substances to be imported or manufactured in New Zealand, while issuing guidelines addressing the risks of substances as a tattoo ink would be consistent with the general approach taken in Europe to date. It is noted