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Proposed Group Standard for Tattoo and Permanent Make-Up Substances

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Proposed Group Standard for Tattoo and Permanent Make-Up Substances Proposed group standard For tattoo and permanent make-up substances June 2011 2 Proposed tattoo and permanent make-up group standard Contents 1. The proposed group standard.................................................................................................... 3 1.1 Background ................................................................................................................................... 3 1.2 Substances used in tattooing and permanent make-up................................................................ 3 1.3 Tattooing and permanent make-up practices in New Zealand ..................................................... 4 1.4 The current regulatory and enforcement situation in New Zealand .............................................. 6 1.5 The proposed group standard ....................................................................................................... 7 1.6 Public consultation ........................................................................................................................ 8 2. Notification of the Authority’s assessment .............................................................................. 8 2.2 Benefits versus economic cost of compliance .............................................................................. 9 2.3 Efficiency and effectiveness ........................................................................................................ 10 2.4 Similar nature, type or circumstance of use ................................................................................ 10 2.5 Best international practices and standards ................................................................................. 13 2.6 Other matters considered by the Authority ................................................................................. 14 3. The next steps ............................................................................................................................ 15 3.1 Notification and other matters for amending a group standard ................................................... 15 3.2 Following consultation ................................................................................................................. 15 3.3 When the proposed group standard comes into force ................................................................ 15 3.4 How to have your say .................................................................................................................. 16 Making a submission .......................................................................................................................... 17 Appendix 1 ........................................................................................................................................... 19 Draft Tattoo and Permanent Make-up Substances Group Standard .................................................... 19 Appendix 2 ........................................................................................................................................... 19 Review of Tattooing and Permanent Make up practices in New Zealand ............................................ 19 Appendix 3 ........................................................................................................................................... 28 Legislation on tattoos and permanent make up in overseas jurisdictions ............................................. 28 Appendix 4 ........................................................................................................................................... 30 Information sheet on proposed Tattoo Inks Group Standard March 2011 ............................................ 30 June 2011 3 Proposed tattoo and permanent make-up group standard 1. The proposed group standard 1.1 Background 1.1.1. ERMA New Zealand is consulting on the proposal to issue a new group standard for approval of substances used in tattooing and permanent make-up. This document provides an assessment of the matters that must be considered before issuing or amending a group standard. 1.1.2. A group standard sets out conditions to safely manage a group of hazardous substances. Most domestic and workplace chemicals are approved under group standards. This proposed group standard will define what chemicals may be used in tattoos and permanent make-up (PMU), and will set out conditions on how they can be used. The proposed group standard will approve substances that meet the scope of the group standard. 1.1.3. On 1 November 2010 the Cosmetics Products Group Standard (CPGS) was amended to exclude ―any substance intended to be ingested, inhaled, injected or implanted into the human body‖. This amendment, therefore, excludes tattoo and PMU substances from the CPGS since they are injected into the skin. This amendment comes into force after 31 October 2011. After this time, tattoo and PMU substances will require a separate HSNO approval. 1.1.4. The Surface Coatings and Colourants Group Standard (SCCGS) applies to substances imported or manufactured for use as a surface coating or colorant. The SCCGS specifically excludes cosmetic products. Removing tattoo and PMU substances from the CPGS meant that they would be covered under the SCCGS since they were no longer a cosmetic. The SCCGS, however, does not adequately manage the risks associated with the use of tattoo and PMU substances. In October 2010 the Authority considered a number of options for managing the risks associated with tattoo inks and determined that the risks associated with these substances would be best managed in a dedicated group standard. The Authority requested that the Agency develop a group standard to specifically cover substances used in tattooing. 1.1.5. Accordingly, the Agency has reviewed the substances used in the processes of tattooing, application of permanent make up and other associated activities. Appendix 2 contains a summary of the review process. 1.2 Substances used in tattooing and permanent make-up 1.2.1 The substances used as tattoo inks and for permanent make-up (PMU) are diverse and historically have not received much regulatory attention. In developing this proposal for a new group standard to cover substances used in tattooing and permanent make-up, the Agency has considered the following points: 1.2.2 Inks used in tattooing are often derived from recipes that were formulated centuries ago when the depth of colour was paramount and toxicity was of little interest. This has led to the inclusion of substances that are now considered unacceptable. While many of these substances have June 2011 4 Proposed tattoo and permanent make-up group standard recently been removed from the colour pigments used today, it is possible that some are still used by manufacturers. 1.2.3 Different colours derive their colour from quite different substances. For example yellow can be produced by azo dyes or cadmium sulphide, and white by lead carbonate, zinc oxide or titanium dioxide. Collectively, the number of potentially toxic substances in the colour pigments is high. 1.2.4 Historically, the formulation of tattoo inks was seen as an art rather than a science with inks being purchased on the reputation of those creating them. Modern manufacturers often encourage this view and are reticent to publish information about the contents of their products. 1.2.5 Until recently hazardous substance regulations internationally have treated tattoo and PMU colour pigments as cosmetics or colour additives and have not taken into account the specific nature of their use. It is only with the recent increase in the popularity of tattoos and PMU and the associated increase in reports of adverse reactions that concerns about their safety have arisen. For example between 1998 and 2003 the FDA received five reports of adverse reactions to PMU. This increased to 150 reports in the period 2003/2004. 1.2.6 Research undertaken over the past decade has identified a range of significant risks associated with some of the substances that have been used for tattooing and permanent make-up. To reduce risks in this area, the EU released an initial resolution in 2003 that places controls on the use of substance for tattooing and PMU. 1.3 Tattooing and permanent make-up practices in New Zealand 1.3.1 The EU resolution on tattoo and permanent makeup substances defines tattooing as the intradermal injection of substances consisting of colorants and auxiliary ingredients in order to impart a skin marking or design (a ―tattoo‖). 1.3.2 Permanent make-up (PMU) is a specialised form of tattooing which involves intradermal injection of colorants and auxiliary ingredients for the purposes of enhancing the contours of the face. Other names include dermapigmentation, micropigmentation and cosmetic tattooing. 1.3.3 In practice, PMU uses a similar technique to tattooing. However, the pigment is not introduced into the skin to the same depth and the colorants used fade, requiring reapplication within two to five years. PMU pigments and techniques are also used in hospitals for nipple areola tattooing following breast reconstruction. 1.3.4 The Agency has consulted with tattooists, beauty therapists and other interested parties seeking information on substances used in tattooing and PMU, their sources, circumstances of use and any other information relevant to the regulation of such substances. 1.3.5 The Agency was unable to identify any manufacturers of substances used in tattooing or PMU in New Zealand. Tattooists, however,
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