How to formulate compliant skin care products

There are stringent regulations surrounding skin care formulations in South Africa. Brands should pay careful attention to what claims they make regarding the reduction of dark spots and pigmentation.

Uneven skin tone is one of the most common skin concerns in South Africa. There are many factors that affect skin tone, from genetics to how often you apply SPF. Other issues such as acne and melasma can also affect the skin’s appearance in the short and long term.

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Texture and colour are two main aspects that make the skin’s tone appear uneven. Formulations that address skin tone often claim to ‘smooth the texture’, ‘decrease the dark spots’, and ‘address redness’. 

In South Africa when it comes to formulations that address skin tone, in particular those that claim to reduce dark spots and pigmentation, one has to pay careful attention to label claims as these are governed by strict regulations.

According to Robyn Brown of Stability Testing Services, a division of Botanichem, it is imperative that label claims and formulation ingredients are compliant with industry regulations.

“You cannot use the words ‘lightening’ or ‘whitening’ in your product claims but not everyone knows this,” explains Brown. “According to the Cosmetics Toiletries and Fragrance Association, CTFA, a product may not claim to bleach, whiten or lighten the skin.”

Whilst products containing ingredients such as steroids, hydroquinone, mercury and lead have been banned in South Africa for some time, other chemicals such as kojic acid and tranexamic acid are also no longer permitted in cosmetic products.

Kojic acid

Kojic acid helps lighten the skin by affecting the production of melanin – the naturally occurring pigment in the body that gives colour to our eyes, hair, and skin. The amino acid tyrosine is needed to support the production of melanin. Kojic acid works by blocking tyrosine from forming, which then prevents melanin production. This decreased melanin production has a lightening effect on the skin. However, concerns have been raised about its safety including the increased risk of sunburn in people with sensitive skin and evidence that kojic acid can lead to skin cancer on damaged skin.

Kojic acid dipalmitate (KAD) is the ester of kojic acid. Aside from it being superior to kojic acid in its whitening ability, it is more stable in cosmetic formulations and not considered harmful to the skin.

“KAD is safe, and it suits people from light to dark skin, however it will not change naturally dark skin, instead it lightens abnormal pigmentation caused by acne scars, melasma, freckles etc,” explains Brown.

Although KAD is safer than kojic acid, products formulated with KAD need to be carefully labelled with a sunscreen warning. This is because, when reducing melanin production, the skin loses its natural protection mechanism. Therefore consumers need to be reminded that their skin requires additional protection from the sun.

Tranexamic acid

In some countries, tranexamic acid is used for skin lightening and to address uneven skin tone. This ingredient comes from the amino acid lysine and is traditionally used as an oral medication to treat heavy menstrual bleeding. When applied topically, it changes the way cells produce melanin, interrupting pathways in the skin that might otherwise lead to an uneven skin tone.

In South Africa, tranexamic acid is a Schedule 4 drug and cannot be used in cosmetics unless registered as a medicine.

Fragrances and allergens

Some changes are expected in the regulations concerning fragrance allergens with an additional 34 Allergens being included in the list of fragrance allergens that need to be declared your product’s INCI listing. 

Furthermore if your fragrance ingredients contain certain essential oils, these essential oils will need to be listed as Allergens on the INCI. In the EU there is a deadline to change ingredient listings on labels and packaging by 2026.

Contact Stability Testing Services, for more information on formulations, ingredients, ingredient regulations, guidance on labelling and how to ensure your products conform to the necessary legal requirements.

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