Stephen Kirk MSc, C Biol – European registered toxicologist, UK OPINION
Cosmetic product safety: old friend or new foe?
Although the safety of cosmetic products in Europe is closely controlled by European legislation, the emerging question is how safe for the consumer are they really? Currently, Article 7a of the prevailing European legislation Council Directive 76/768/EEC, merely requires that manufacturers of cosmetic products have readily available an assessment of the safety for human health of the finished product. This safety assessment should include, among other things, the general toxicological profile of the ingredients, their chemical structure and level of exposure. However, the recent recast of the EU cosmetic legislation, Regulation (EC) No 1223/2009, now requires a more detailed safety assessment to be performed for cosmetic products placed on the market from 11 July 2013, the date upon which the Regulation comes into force. Indeed, the Regulation now describes explicitly the specific information that is required to form part of the safety assessment, now called the Cosmetic Product Safety Report (CPSR). Taking its lead from the 7th Revision of the SCCS’s Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (where the Committee describe the desirable toxicological studies and principles for the safety assessment of cosmetic ingredients and subsequently finished products) Annex I of Regulation 1223/2009 (the CPSR) clearly states that the CPSR should contain the specific details of the toxicological profile of the substances in a cosmetic product for all relevant end-points, with a particular focus on an evaluation of local toxicity such as skin and eye irritation and skin sensitisation, as well as systemic toxicity and corresponding margins of safety if systemic exposure is likely to arise following normal and foreseeable usage of a cosmetic product.
Although the clear inference from Annex I is that it is classic toxicity end-points that only need to be considered during a cosmetic product’s safety assessment, the cosmetic action being attributed to ingredients in the 21st century could be
Although the usage of bromelain as a food additive has been reviewed and approved by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) with an Acceptable Daily Intake of ‘Not limited’, in their 15th Report, the Committee acknowledged the possibility of allergic reactions following skin application of enzymes used as food additives.1 However, the possibility of such reactions occurring was subsequently discounted, since the route of exposure was through the diet, which was considered to be equivalent to the normal dietary exposure to proteins and protein fragments. With this in mind, Kelling et al.2 evaluated the safety of
and Sarlo et al.3
Bromelain is manufactured from the waste of the pineapple processing industry.
considered to be outside of the scope of the SCCS’s Notes of Guidance, for example proteolytic enzymes, peptide growth factors and other metabolic enzyme inhibitors. Recently, it was reported in the online
journal, Cosmetic Design (8 February 2012), that researchers in Thailand had isolated and characterised the enzyme bromelain from waste pineapple material following the processing of this plant for food usage. It was reported that pineapple waste such as peel, core, stems and crown contained appreciable amounts of this proteolytic enzyme, which could in turn be commercially beneficial to the pineapple processors.
Bromelain is one of a family of proteolytic enzymes isolated from the pineapple plant which among other applications finds usage in the food industry and diagnostic medical laboratories, for example as a meat tenderiser and in blood typing procedures. Its usage as a cosmetic ingredient is somewhat limited though, primarily on the grounds of cost, essentially being limited to oral care or premium skin care products. However, the availability of a cheap and plentiful source of the enzyme could open up its usage in mass market brands for its ‘natural’ exfoliating action.
bacterial proteases as prototype cosmetic ingredients in both rinse-off (soap bar cleansing product) and leave-on applications (moisturiser body lotion). These studies were performed with the knowledge that protease enzyme usage in household laundry products has been shown to produce IgE-mediated hypersensitivity in workers handling detergent enzymes in the occupational setting, primarily through respiratory exposure to enzyme dusts.
Both these studies revealed that a number of volunteers developed Type I hypersensitivity to the enzyme in the two prototype products being evaluated, and that respiratory exposure to airborne enzyme was responsible for antibody elicitation. Production of antibody in both studies was also highly time-dependent, taking at least four months of exposure before measurable levels were detected in the blood of volunteers. However, none of the volunteers with elevated antibody titres in either study reported any respiratory symptoms typical of Type I hypersensitivity. Similarly, the only dermal symptoms reported during the studies were considered to be consistent with an irritant response to the prototype products being evaluated. It was subsequently concluded that the induction of the allergic antibody was sufficient grounds to discontinue the development of these prototype protease- containing personal care products.
April 2012 PERSONAL CARE 81
www.en.wikipedia.org
Markus Leupold-Lo?wenthal
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