Sunscreens their special and unique non-gmp requirements Dusanka Sabic Regulatory Reform Director, Accord Australasia November 2017
What I will be covering today Sunscreen regulation as cosmetics impact of proposed changes to industrial chemicals regulation Changes to therapeutic goods regulation which impact on sunscreens Proposed sunscreen reform and implications for GMP Other reforms which will impact on sunscreens
Sunscreen regulation Sunscreens are regulated as either cosmetics or therapeutic products Cosmetic sunscreens are colour cosmetics, lip products, sunbathing products (with any SPF) or moisturisers with SPF 15 or less Therapeutic sunscreens are products used primarily for protection from UV radiation, SPF 4 or more and moisturisers containing sunscreen with SPF greater than 15 - includes insect repellants Australian sunscreen standard defines secondary and primary
Sunscreens as cosmetics New industrial chemicals framework 1 July 2018? Cosmetic standard will no longer apply The TGA will articulate interface on cosmetic and therapeutic requirements Introduction of animal test ban for cosmetic ingredients
Overview of categorisation
Exposure band criteria - Key concepts
Ban on cosmetic animal testing Overview An election commitment to implement a ban commencing 1 July 2018 Extensive consultation including consumer survey Part of industrial chemicals legislation reform package Ban to follow international practice
Animal test ban proposal As currently drafted, the legislation aligns with the EU ban Chemicals with industrial uses other than in cosmetics can use animal test data Only cosmetic and personal care ingredients affected by the ban Therapeutic goods are exempt Development of Industry Code for consumer education and cosmetic claims
Accord position on animal test ban Committed to animal welfare and safety for consumers, workers and the environment Support a workable, practical, evidence-based approach Supported the current bill as is aligned with major trading partners and included realistic transition timeframe We would have preferred to see cosmetic ingredients removed from the scope of industrial chemicals legislation
Where are we now? In June 2017, The Industrial Chemicals Bill 2017 was introduced and read for the first time in parliament The bill has passed the House of Representatives and sits in the Senate The delegated legislation is still under development Commencement date of 1 July 2018 looks unlikely Political environment is out of our control
Permissible Ingredients Determination On 1 January 2016, a new legislative instrument under section 26BB of the Therapeutic Goods Act 1989 commenced This instrument brings together all of the ingredients that are available for use in listed medicines and their associated requirements Common issues raised by Accord members include: Previously not all proprietary ingredients were required to be evaluated, flavors (5%), fragrances (1%) and inks (0.1%) The TGA advised that implementation of 26BB would not change existing requirements nor result in any changes to industry business processes Lack of transparency and timeliness of 26BB decisions and timing when an assessment would appear on the 26BB list and available for use
Labelling of Sunscreens as therapeutic goods In August 2016 the new labelling order - TGO 92 Standard for labels of non prescription medicines was introduced A 4 year transition period for the implementation of TGO 92 to eventually replace TGO 69 TGO 69 will remain in existence until the end of the 4 years Full compliance with new requirements will be 1 September 2020
TGO 92 sunscreen exemptions Minor changes to current labelling requirements for sunscreens Sunscreens may list the actives on side panel Main label requirements do not apply to information on side or rear panel i.e. each active ingredient does not need to appear on a separate line Certain exemptions small containers i.e. multiple active ingredients presented on continuous line
Impact of Expert Review Impact of reforms for complementary medicines have had an unintended consequence for sunscreens Any change to listed medicines impact on sunscreens, e.g. permitted ingredients and permitted indications Changes to advertising Introduction of pharmacovigilance inspection programme
Permitted indications September 2016 Government announcement that TGA will introduce a list of permitted indications for all listed medicines The purpose is to: Ensure that listed medicines can only make low level indications Provide transparency for sponsors on what indications are suitable for listed medicines Avoid consumers being misled by inappropriate indications
Permitted indications (cont ) Permitted indications reforms to commence January 2018 with 3 year transition period Indications which are not compliant with AS/NZS 2604:2012 will not be included in permitted indications list after 2021 Sunscreens compliant with AS/NZS 2604:1998 will not be able to make claims such as SPF30+ Products not compliant with with new indications will be cancelled
Reforms to low risk therapeutic goods Part of a wider review of medicines and medical devices Recommended further review for low risk products of which sunscreens is one product category Also looked at range of other product categories such as: Household disinfectants Tampons Desensitising toothpaste Antiseptic mouthwashes Antiperspirants Acne products
Therapeutic sunscreen reform options Status quo Streamline regulatory pathways Prevent secondary sunscreens from making SPF claims Create GMP for primary sunscreens New ingredient approval process Alternative ingredient approval process Exclude all sunscreens from regulatory framework
Accord position on sunscreen reform Support all sunscreens regulated as cosmetics but being pragmatic this will not happen in Australia Support all secondary sunscreens regulated as cosmetics Support alternative GMP to PICS Support streamlining of ingredient approvals Support a regulatory instrument for all of the controls for primary sunscreens regulated as therapeutic goods
Other initiatives which impact on sunscreens Revision of Australian sunscreen standard Unit measure flexibility in quantity statement display Biosecurity new requirements for imported products
Revision of sunscreen standard ISO requires 5 year review of standards: ISO 2443 Determination of sunscreen UVA protection in vitro ISO 2444 Cosmetics-Sun protection test methods In vivo determination of the sun protection factor (SPF) This will also lead to review of AS/NZS 2604:2012
Unit measure slow process to reform 2014 reform proposal to introduce flexibility of unit measurement mark or quantity statement placement Current requirement for quantity statement to be on front of pack 2015 industry consultation including consumer survey 2017 Options Paper to move towards flexible principles-based approach with 3 options for reform Current favoured option is for principles-based approach requiring quantity statement to be legible and prominent
Biosecurity Cosmetic Case BICON is the Australian Government's Biosecurity Import Conditions database The BICON system replaced the Import Conditions (ICON) database Introduction of new arrangements has led to significant increase in regulatory red tape for low risk finished cosmetic products New arrangements commenced 16 June 2016
Biosecurity Cosmetic Case BICON now requires a manufacturer s declaration or equivalent (supplier s declaration, invoice or product label) for all consignments of cosmetics entering Australia. Even for cosmetics that contain only synthetic chemicals. Further documentation may be required for products containing animal, microbial or plant derived ingredients. More information at: https://bicon.agriculture.gov.au/biconweb4.0/importconditions/questions/evaluatecase?elementid =0000067907&elementVersionID=177
Thank you Dusanka Sabic dsabic@accord.asn.au +61 422569222