PDF printable version of Aldous-Easton-Roberts submission (PDF 94 KB)
Department of Health and Ageing MDP 71
GPO Box 9848
CANBERRA ACT 2601
Attention: Mr G Barden
Office of Chemical safety
Prof M S Roberts
NHMRC Senior Principal Research Fellow MDP 71 Prof of Clinical Pharmacology, University SA
Prof of Therapeutics & Pharmaceutical Sciences, Uni SA
Dr G Aldous
Project Manager, Research and Development School of Pharmacy and Medical Sciences, University SA
Ms R Easton
Chair Product Safety ISO/COPOLCO, CHOICE, SOCAP Consumers’ International, Consumers' Federation of Aust
In response to your invitation to stakeholders, on the second round of consultations for the review of the National Chemical notification and Assessment Scheme (NICNAS), please find comments below sent by Professor Mike Roberts, Dr Graham Aldous and Ms Robyn Easton. Professor Roberts is Professor of Clinical Pharmacology and NHMRC Senior Principal Research Fellow at the University of Queensland. Dr Graham Aldous is Project Manager of Research and Development at the School of Pharmacy and Medical Sciences, University of South Australia and Robyn Easton is Chair of Product Safety at ISO/COPOLCO and Consumer Advocate for over 20 years. Both Professor Roberts and Robyn Easton are members of the NICNAS Cosmetic Advisory Group.
In our submission for the first round of consultations to the review of NICNAS, we raised three main areas of concerns – the need for Australian cosmetic guidelines to more closely follow European guidelines; elements required for safer regulatory control of sunscreens; and the gap that currently exists in safety requirements for formulations. We have read, with interest, the Discussion Paper of June 2012, drafted from responses to the first round of consultations. We note, with great disappointment that the concerns above that we raised have largely been ignored. There has been some mention of possible alignment to regulatory processes of other countries (page 11) and the adoption of restrictions that other countries have imposed to protect Australian consumers from these ingredients (page 12). However, these refinements are barely mentioned in the Summary of Options attached to the Discussion Paper as Attachment A (page 45).
May we re-emphasise that current Australian TGA regulations for therapeutic substances follow closely those developed and established by the corresponding European Agency. The proposed guidelines for cosmetics, as regulated by NICNAS, do not. We submit that the current Australian regulations governing the manufacture and sale of cosmetics should be upgraded to follow European guidelines as closely as possible. The discrepancy which now exists 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”. This is a positive product safety initiative that the NICNAS Review Committee should consider.
Particularly relevant statements from these European regulations include:
- 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.
- Article 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, we request the NICNAS Review committee to consider adopting these regulations in their entirety, not only from a Consumer safety perspective but also from an Industry perspective.
The Productivity Commission Research Report: Chemicals and Plastics Regulation, July 20083
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. In the current NICNAS environment, this is perpetuated. 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 interactions with other ingredients are vital and must also be considered for safety reasons.
NICNAS must note that there are chemicals 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
. 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 skin5
. It appears that no consideration is being given to how suboptimal formulations may lead to a potential higher exposure for children than desirable. It has been recognised in the Discussion Paper that the fragmented regulatory system has created gaps in Australian regulation (page 10). The above examples highlight this safety deficiency.
The section on Chemicals in Cosmetics ( page 39) requires bre-evaluation. Cosmetic science is now relatively well developed and can be used to minimise the risk of substance and 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. The recommendation H1 (page 50) to transfer the responsibility for administration and enforcement of the Cosmetics Standard 2007 to the ACCC will not solve the existing gap in the regulatory process. The NICNAS Review committee should consider the safety of Consumers and be proactive in their protection regime of the assessment of chemicals rather than the current unsafe situation which is reactive after the fact, once a Consumer has been compromised and injured and the outcome is presented as incident data. Furthermore, we submit a strong recommendation that the Australian Government adopt the well planned and considered guidelines being implemented by the Europeans rather than end up with ill-defined guidelines that limit Australia's product quality, international competitiveness and consumer safety.
We trust these comments assist your deliberations and are considered during your second consultation.
Prof M.S Roberts BPharm MSc PhD DSc MBA FACP
Dr Graham Aldous PhD, BSc (Hons), MRACI, Chartered Chemist
Ms Robyn Easton BSc (Hons)
A full list of all 2012 submissions can be viewed at June 2012 submissions to the review of NICNAS