How cosmetics are currently regulated in South Africa

A global increase in demand for natural and organic products, including cosmetics has emerged. Consumers are now more sensitive towards the sustainability of manufacturing processes, its impact on the environment and the absence of harmful ingredients. With South Africa’s unique biodiversity this demand not only creates enormous local business opportunities, but also begs formal legal regulation.

Why the need for formal regulation

Many of the up to 23 ingredients of cosmetic products are imported and subject to an ad valorem or “luxury” tax in addition to excise duties and further considering the volatility of the rand it is clear that the production of cosmetics locally is an expensive business. This is why more and more local manufacturers are turning to South Africa’s indigenous flaura which is regulated by the National Environmental Management: Biodiversity Act 10 of 2004 and the Nagoya Protocol, after South Africa became the 12th signatory in 2013. With local direct selling company, Avon, only trumped by international giant Revlon, having the second biggest market share in South Africa, it is further clear that local manufacturers can and wants to compete internationally. Avon, and other direct selling companies such as Annique, Avroy Shlain, Vanda, Sh’zen and Jean Guthrie already trade freely on the African continent as a result of being part of the Southern African Customs Union.

It is thus surprising that an industry of this extent is currently only self-regulated in South Africa, although the Department of Health (DoH) has proposed a bill to Parliament “…to start regulating the cosmetics industry…” according to Sinah Mosehla, Director of Cosmetics, Department of Trade & Industry (DTI).

Formal regulation is much needed to attend to, amongst other, controversies such as the obligation to register cosmetic products in countries to which such products are exported, while no such registration is required in South Africa, even though South African products are compliant with the International Organisation for Standardization’s (ISO) standards.

Current regulatory framework

The South African cosmetics industry has been self-regulated for years and mainly depends in this regard on the Cosmetic Compendium of the Cosmetic, Toiletry and Fragrance Association of South Africa (CTFA). This comprehensive compendium, containing sections, amongst other, on Good Manufacturing Practice (GMP); primary cosmetics with secondary antibacterial / antifungal function; labelling, advertising and composition of cosmetics in South Africa; microbial testing for cosmetics and a list of substances which must not form part of the composition of cosmetic products has been developed by CTFA in consultation with the cosmetics industry, government and the South African Bureau of Standards (SABS). European regulations were closely followed during this development so that South African cosmetics can also be sold in the European Union.

Oddly enough, when Cosmetics Europe, a personal care association in Brussels, issued an industry-wide notice on 12 December 2014 to discontinue the use of the preservative Methylisothiazolinone (MIT), a leave on skin product, based on clinical data showing adverse skin reactions to this ingredient, CFTA advised that this ingredient is not banned in South Africa until the investigation by the Scientific Committee on Consumer Safety has been finalised.

In case of unsubstantiated claims, when unpermitted ingredients are used or substandard products are sold, complaints can be made with the Advertising Standards Authority (ASA) or the Consumer Commission in terms of the Consumer Protection Act 68 of 2008 which contains section relating to the quality of products in the market; consumer safety; advertising; promotions and marketing; communication between suppliers and consumers and contractual terms and conditions.

Due to the chemical composition of most cosmetics, making it “high” risk products, companies are strongly encouraged to be certified by DQS or SGS as ISO 22716 (GMP) compliant which will serve as a guarantee of quality to consumers.

The Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972 regulates the sale, manufacture, importation and exportation of cosmetics, along with foodstuffs and disinfectants due the similar production processes followed during the manufacturing of these products.

In March 2013 the European Union banned any form of animal testing of cosmetic products and their ingredients completely, while organisations such as BUAV, founded by Cruelty Free International, still aim to implement a global ban in this respect. In the meantime companies can obtain the Leap Bunny certificate if their products is found to be produced without animal testing in all of the company’s global operations.

Medical v cosmetic claims

The Foodstuffs, Cosmetics and Disinfectant Amendment Act 8 of 2008 defines a “cosmetic product” as follows:

A cosmetic product shall mean any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and mucous membrane of the oral cavity with a view of exclusively or mainly to clean them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition

except

where such cleaning, perfuming, protecting, changing, keeping or correcting is wholly for the purpose of treating or preventing disease.”

Any products meant to be inhaled, ingested or applied to body parts not specified in this definition are not cosmetics and might qualify as medicine which must be registered with the Medicines Control Council (MCC) in terms of the Medicines and Related Substances Control Act 101 of 1965 after clinical safety and efficacy have been sufficiently proven. Although primary cosmetics can also have a secondary function, such as an antibacterial or antifungal body wash, such secondary claims can only be made in a cosmetic sense, otherwise the product might be subject to registration as afore mentioned.

In efforts to enhance products’ competitive edge and to circumvent the registration requirements the term “cosmeceutical” has been encountered. However, Item 2.9 of the Medicines Control Council’s Minutes of March 2000 strictly prohibits the use of this term as a result of being misleading. Subsequently any claims, in respect of cosmetics products, implying health related properties must be substantiated with scientific proof.

Thus, to help local producers and manufacturers flourish in the international market and to create much needed jobs in South Africa by making use of our abundant indigenous knowledge and biodiversity, formal regulations must be developed to ensure safety to consumers and legal certainty for manufacturers, producers and suppliers.