PDF printable version of Michael Roberts' submission (PDF 67 KB)
Department of Health and Ageing
GPO Box 9848
CANBERRA ACT 2609
18 December 2011
I write to you in my capacity as an individual, but comment that I am a NHMRC Senior Principal Research Fellow, the Professor of Clinical Pharmacology at the University of Queensland and the Professor of Therapeutics & Pharmaceutical Sciences at the University of South Australia. My credentials include more than 400 peer reviewed papers, 3 textbooks on topical products, many overseas invited presentations and service on the regulatory bodies for Europe, Canada and Australia. In relation to this submission, I am a member of NICNAS’s Cosmetic Advisory Committee.
Australian TGA regulations for therapeutic substances follow closely those developed and established by the corresponding European Agency., However, the proposed guidelines for cosmetics, as regulated by NICNAS, do not. In my view, the current Australian regulations governing the manufacture and sale of cosmetics should be upgraded to follow European guidelines as closely as possible.
The current discrepancy has implications on both patient safety and the Australian economy. By appropriate marketing, foreign multinationals will be able to claim that their products are superior to local products, placing Australian cosmetic products at a significant disadvantage.
The European Community, in adopting their new Cosmetic Products Regulations EU Regulation 1223/20091, has taken steps to provide better safeguards for their Consumers2. According to the Cosmetics Directive 76/768/EEC, Article 2, “a cosmetic product put on the market within the Community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use”. I believe that this is a positive step forward and the NICNAS Review Committee should follow this approach.
Particularly relevant statements from these European regulations include:
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- Article 3 – Safety. A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use...
- Article 10 - Safety assessment. In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up ..The responsible person shall ensure that: (a) the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment; (b) an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources; (c) the cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market.
- (30) - At present, there is inadequate information on the risks associated with nanomaterials. In order to better assess their safety the SCCS should provide guidance in cooperation with relevant bodies on test methodologies which take into account specific characteristics of nanomaterials...”
Furthermore, under the Cosmetic Directive in Europe, manufacturers of sunscreens are required to:
- ensure formulations cause no damage to human health when applied under normal or reasonably foreseeable conditions of use.
- to have a safety assessments of the formula carried out and ensure the results are available for inspection.
- conduct a safety assessment and produce a product safety report prior to placing a cosmetics product on the market.
- appoint a “responsible person” for relevant legal obligations which include responsibilities for products supplied to consumers from outside the EU, for example, via the internet.
- to report serious, undesirable effects to the authorities as part of an early detection mechanism.
- products for children under three must undergo a specific safety assessment that takes account of their special needs, for example, their higher skin surface area to body
- weight ratio. The person who carries out the safety assessment must have adequate qualifications and relevant experience and hold a recognised diploma in pharmacy, toxicology, dermatology, medicine or a similar discipline.
- the national governments of EU Member States have surveillance systems that monitor compliance with all requirements.
- an official body in each country carries out in-market control inspections. These bodies have powers to analyse samples for compliance with requirements for labelling, ingredients and microbiological quality.
With these measures in mind, in providing regulatory control of Australian cosmetics, including sunscreens, I request the NICNAS Review committee considers adopting these regulations in their entirety, not only from a Consumer safety perspective but also from an Industry perspective.
In my observation, The Productivity Commission Research Report: Chemicals and Plastics Regulation, July 20083
has only considered cosmetic issues in terms of chemical ingredients included in products, as distinct from the formulation of products. The report emphasises the hazards
of individual chemicals and appears to fail to recognise that risk also involves exposure to chemicals
, defined by the nature of the product and how and where it is used. For instance, paraben preservatives are generally safe in an appropriately formulated product. In a poorly formulated product, parabens can be absorbed through their skin where they can cause an allergic reaction and show potential estrogenic effects. The concentration of paraben in the formula is important but also interactions with other ingredients are vital and must be considered. There are ingredients which are quite innocuous when considered in isolation as a single product ingredient, but when combined with other products, they have additional properties and significant consequences to the Consumer. An example of such a reaction is the enhanced absorption of sunscreening agents when formulated in combination with octyldodecyl neopentanoate (Elefac-I-205).
Another example is the commonly used sunscreen ingredient, oxybenzone. A margin of safety of greater than 100 is normally applied in the toxicological assessment of chemicals, including this sunscreen. However, the safety margin for oxybenzone is estimated to be only 40 when this sunscreen is applied to children in current formulations4
. Our experimental data suggests that common Australian sunscreen products manufactured specifically for children, deliver the same amount of benzophenone as the adult formulations manufactured for adult skin.5
It appears that no consideration is being given to how suboptimal formulations may lead to a potential higher exposure for children than desirable.
Cosmetic science is now relatively well developed and can be used to minimise the risk of substance or maximise the efficacy of cosmetic ingredients. The key question the Review committee should consider is whether the European pre-emptive, premarketing safety assessment, in combination with labelling requirements, avoids more risks than the Australian ACCC post - market activities such as product warning notices, product bans and product recalls)6
. The NICNAS Review committee should consider the safety of Consumers and be proactive in their protection regime rather than being reactive after the fact once a Consumer has been compromised and injured.
I trust these comments assist your deliberations.
M.S Roberts BPharm MSc PhD DSc MBA FACP firstname.lastname@example.orgTop of Page
Submission supported by Ms Robyn Easton, BSc (Hons)
- the Consumers’ Federation of Australia representative on the NICNAS Cosmetic Advisory Committee;
- the Chair of Product Safety Working Group, International Organisation for Standardisation Consumer Policy Committee;
- a Member of Asian Network of Consumer Organisations; the Australian Consumers’ Association; CHOICE; the Society of Consumer Affairs Professionals;
- the Winner of 2002 Standards Australia National Excellence in Standardization and Outstanding Service Award and member of 2008 Standards Australia National Award for Committee of the Year
- a former:
- Vice Chair of the Technical Advisory Council of the Joint Accreditation System of Australia & NZ; Councillor of National Association of Testing Authorities, Australia;
- member of Victorian Government Solaria Reference Group;
- member of the Registrar Accreditation Board and the Quality Society of Australasia International Consumer Safety Design Professional Team
- and member of the Registrar Accreditation Board and the Quality Society of Australasia International Product Recall Coordinator Scheme Team
- and a Consumer advocate for over eighteen years.