New EU Restriction on Dihydroxyacetone or DHA

The European Commission published an amendment to the Cosmetics Regulation (EC) No. 1223/2009 including 1,3-dihydroxy-2-propanone (INCI: Dihydroxyacetone or DHA), in applications for skin conditioning and tanning, adding the substance as a new entry to Annex III, at Commission Regulation (EU) 2021/1099 of 05 July 2021.

Dihydroxyacetone (or DHA) is primarily used as an ingredient in sunless tanning products. It is often derived from plant sources such as sugar beets, sugar cane, and also by the fermentation of glycerin.

DHA was first recognized as a skin colouring agent by German scientists in the early 1920s. Through its use in the X-ray processes, it was noted as the substance was causing the skin surface to turn brown when spilled.

This skin browning effect is non-toxic and is a result of a Maillard reaction. DHA reacts chemically with the amino acids in the protein keratin, the major component of the skin surface. Different amino acids react to DHA in different ways, producing different tones of coloration from yellow to brown. These are similar in coloration to melanin, the natural substance in the deeper skin layers which brown or “tan” from the exposure to UV rays.

The first consumer sunless tanning lotion was introduced into the marketplace in the 1960s. Today, DHA is the main active ingredient in many sunless tanning skincare preparations, and can be used alone or combined with other tanning components such as erythrulose. DHA is considered the most effective sun-free tanning additive.

Self-tanning products in the EU will now be limited to a maximum of 10% DHA based on the SCCS safety evaluation. The regulation also set a limit of 6.5% for use in non-oxidative hair-dye products.

Consumer products are not likely to be affected because the concentration used at cosmetic products is much lower than the indicated at the new entry of the Regulation (EC) 1223/2009 to gradually develop colour. Concentrations greater than 10% used for faster tanning and darker skin tones will no longer be permitted in the EU in early 2022, triggering reformulation for these cosmetic products.

Sunless tanners may be an effective alternative to UV-induced tanning but bear in mind that they do not provide sun protection! They should never be used in place of sunscreens. IF you are going to stay under the sun please use a proper sunscreen product with a very high protection level.

If you have any question about the compliance of your products in the EU or in the UK market please contact us, we will be glad to help!



According to sources1, 2, at the topical level, cannabidiol (CBD) acts as an adaptogen, which means that it is capable of increasing the ability to adapt to environmental factors and avoid the damage caused by them. This is why CBD will be use  in cosmetics.

This molecule binds to different receptors3 (CB1 and CB2) found at different levels of the skin involved in maintaining skin homeostasis. Various cannabinoids are attached to these receptors, including CBD, acting in the regulation of different epidermal processes.

The adaptability of this ingredient and its possible implication in maintaining skin homeostasis, which translates into an interest in using it in anti-aging and sebum-regulating cosmetics, leads us to carry out an analysis on the legality of its use .

CBD in cosmetics: FDA4

Currently, the FDA does not have an established regulation that regulates the use of CBD in cosmetics. Despite this, based on previous studies, they do not recommend its use in pregnant or lactating women in any type of preparation, as it can cause damage or slow down the development of the baby.

Although cosmetic ingredients and products do not need approval by the FDA, prior to their marketing in the United States, before launching a cosmetic in this market we must ensure that it is safe and effective, since this agency does not approve, but it does you can recall a cosmetic from the market. That is why the only legislation established by the FDA for ingredients like CBD is that:

  • We must ensure that the product is safe for consumers when used in accordance with normal conditions of use.
  • It should not be mislabeled, in terms of concentration and function of the ingredients it contains.
  • If the CBD cosmetic can affect the structure or some function of the body, it can also be considered a medicine and must be approved by the FDA. This is so because for this organism there is a dual classification of a product.

CBD in cosmetics: European legislation5

According to European Regulation 1223/2009, the use in cosmetics of narcotic drugs included in the Single Convention of 1961. Although CBD is not on this list, tetrahydrocannabinol (THC) is.

That is why the use of CBD in cosmetics, in Europe, is prohibited if it comes from extracts, tinctures or resins of the “Cannabis Sativa” plant as it may contain THC; but it can be used, if it comes from seeds or leaves. In these cases, it is necessary to have documentation that corroborates that it comes from these parts of the plant, and not from others. In addition, documentation is needed indicating its tetrahydrocannabinol (THC) content.

On the other hand, the use of synthetic CBD is allowed, which is currently the safest and most recommended, since we ensure that there is no presence of THC.

Although there is currently no legal framework that regulates the percentage of THC allowed in cosmetics, the WHO Expert Committee on Drug Dependence (ECDD) proposed in 2019 possible changes to the Single Convention of 1961, which would include an indicative note: “Preparations that contain predominantly cannabidiol and less than 0.2% THC, are not under international control ”.

Basically, this ingredient generates great interest in the cosmetic industry as a source of innovation. Despite this, there are still no well-established legal frameworks to indicate what can be done with it; but it is clear under what conditions we cannot use it.


  1. Oláh A, Tóth BI, Borbíró I, Sugawara K, Szöllõsi AG, Czifra G, Pál B, Ambrus L, Kloepper J, Camera E, Ludovici M, Picardo M, Voets T, Zouboulis CC, Paus R, Bíró T. Cannabidiol exerts sebostatic and antiinflammatory effects on human sebocytes. (2014) The Journal of Clinical Investigation. 124(9):3713-24.
  2. Papaseit E, Pérez-Mañá C, Pérez-Acevedo AP, Hladun O, Torres-Moreno MC, Muga R, Torrens M, Farré M. Cannabinoids: from pot to lab. Int J Med Sci 2018; 15(12):1286-1295. doi:10.7150/ijms.27087. Available from
  5. Reglamento (CE) 1223/2009 del Parlamento Europeo y del Consejo, de 30 de noviembre de 2009, sobre los productos cosméticos.