On 19 August, the South African Department of Health (DoH) published draft regulations relating to the labelling, advertising and composition of cosmetics in terms of the Foodstuffs, Cosmetics and Disinfectants Act 54 of 1972.
According to Spoor & Fisher, in summary, these draft regulations provide for:
- categories of cosmetics products
- measures to ensure the safety of these products
- a mandatory product information file
- Good Manufacturing Practice (GMP)
- prohibited substances in the composition of cosmetics
- labelling requirements
- product claims
Implications for entire industry
The draft regulations involve a large portion of the industry value chain, including the manufacturer, packer, distributor, importer or brand owner making use of a contract manufacturer.
One particular draft amendment states that no person may sell, manufacture or import any cosmetics that ‘may cause damage to human health when used under normal or reasonably foreseeable conditions of use’. Further requirements state ‘the manufacturer, packer, and distributor must keep a product file for each cosmetic product, and that the manufacture of goods must comply with GMP’.
The amendments also focus on prohibited substances, which are listed in the draft regulations. None of these substances may be included in a cosmetics formulation.
Cosmetics manufacturing also comes under the spotlight in the draft regulations with regard to GMP compliance, requiring production in accordance to the international standard ISO 22716.
An already self-regulated industry
According to the Cosmetic, Toiletry and Fragrance Association of South Africa (CTFA), the local industry is currently effectively self-regulated. Adelia Pimentel, the CTFA’s executive director and Judy Nobin, its technical manager, were asked to comment on the matter: ‘South Africa primarily aligns with EU regulations and only customises to follow specific aspects of local legislation, codes and practices. Products are required to meet guidelines laid out in the CTFA Cosmetic Compendium with additional requirements to meet local standards and practices’.
Pimentel and Nobin added that self-regulation principles have underpinned the local industry since CTFA inception in 1994 and members have been compliant in all aspects.
Claim substantiation extremely important
Once promulgated, the new regulations will see claim substantiation becoming a major driving force in the market. This is because the draft regulations state ‘the manufacturer, packer, distributor, importer or person on whose behalf the cosmetic is packed, must refrain from making any claims in respect of the cosmetic, its nature, effects and quality that cannot be scientifically substantiated and must refrain from using the words “clinically proven” unless scientifically substantiated’.
The draft regulations also set out penalties for non-compliance. For example, under these regulations it is an offence to label a product ‘recommended by doctors’ or’ to imply that a product is recommended by doctors’. This adds weight to the previous regulations set out in the CTFA Cosmetic Compendium.
The CTFA believes that the DoH regulations are a positive step within the regulatory framework, building on the sound structure developed by the association over the last 22 years. The CTFA is also working with members to prepare, collate and submit comments to the department during the public comment period.
Written submissions and comments to the proposed regulations must be submitted within three months of the publication of the draft, i.e. by 19 November 2016.