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Cosmetics Regulations

Some substances have been withdrawn

Ingredients presenting new health concerns may no longer appear in cosmetic products. Obviously, there is one thing cosmetics must not do: harm the user.
Marta Campbell
05.04.2022  08:30 Uhr

Cosmetics should care for the body, ensure well-being and make people more beautiful. Therefore, there are strict regulations as to which substances may not be used at all or only to a limited extent in care products. The regulations are uniform throughout the EU and can be found in Regulation (EC) No. 1223/2009 on cosmetic products, for short the Cosmetics Regulation. The regulation has eight annexes, of which Annexes II to VI refer to substances that may be used in cosmetics with restrictions or are even prohibited. The lists are adjusted as soon as scientific knowledge about substances changes. The changes are initiated by the inclusion of ingredients in Table 3 of Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation for short). The CLP Regulation is an EU chemicals regulation that outlines the classification, labelling and packaging of substances and mixtures. Said Table 3 contains the harmonised classifications and labels of hazardous substances.

On 31 August 2021, the 15th ATP (Adaptation to Technical Progress) to the CLP Regulation came into force, its application deadline was the1 March 2022. In the course of this, the list of substances in Annex VI was extended and updated. Some substances were newly classified as carcinogenic, mutagenic or toxic to reproduction (CMR substances from Carcinogenic, Mutagenic and toxic to Reproduction). In the EU Cosmetics Regulation, the substance lists in the annexes were adjusted accordingly, so that the use of 23 CMR substances in cosmetic products has also been prohibited since 1 March 2022.

Exemptions for CMR substances

Whether a substance has CMR effects in humans is not always clearly established. Depending on the level of evidence of their CMR properties, substances are assigned to categories 1A, 1B or 2 under the CLP Regulation:

  • Categories 1A: proven in humans
  • Categories 1B: proven in animal studies, suspected in humans
  • Category 2: suspected substances

The individual categories thus refer exclusively to how certain a CMR effect on humans has been proven to be. However, the classification says nothing about how strong the Potenzial CMR effect is. For example, a carcinogenic substance in category 2 can already have an effect at lower concentrations than a substance in category 1A.

Article 15 of the Cosmetics Regulation stipulates that substances classified as CMR substances of category 1A, 1B or 2 in Table 3 of Annex VI of the CLP Regulation may not be used in cosmetic products. However, exemptions are possible under the conditions laid down in Article 15. For example, a category 2 CMR substance may be used in cosmetics if it has been found safe for use in cosmetic products by the Scientific Committee on Consumer Safety (SCCS). In exceptional cases, even CMR substances of categories 1A or 1B may be used. The conditions include that the substances must meet the food safety requirements according to the Basic Food Regulation and that the SCCS has found them safe for use in cosmetic products according to strict criteria.

However, manufacturers are then responsible for labelling the products accordingly. The exemptions are routinely reviewed every five years after substances have been included in Annexes III to VI. In case of safety concerns, the SCCS also re-evaluates the respective substances on an ad hoc basis.

Lilial and zinc pyrithione

Of the 23 substances currently included as CMR substances, two in particular are relevant to practice: the fragrance Lilial and the biocide zinc pyrithione. Both substances have been upgraded in the risk assessment to »Repr. 1B«, i.e. »probably toxic for reproduction«. The products concerned had to be withdrawn from sale before 1 March 2022.

Zinc pyrithione is found in some anti-dandruff shampoos, but also, for example, in a shaving cream by Avène. The substance was already controversial because it can irritate the skin and is toxic to aquatic organisms. In cosmetics, it can be found as Zinc Pyrithione according to the International Nomenclature of Cosmetic Ingredients (INCI).

Lilial is contained as a synthetic fragrance in numerous cosmetics. Organisations such as the German Allergy and Asthma Association (DAAB) or online databases such as CodeCheck have long warned against the ingredient because it can trigger skin irritations and allergic reactions with inflammation, itching and blistering. On the outer packaging, Lilial is usually labelled with the INCI designation Butylphenyl Methylpropion or also Lysmeral.

Besides Lilial, other fragrances are also controversial. However, consumers cannot always tell which fragrances are contained in a product. Fragrances may generally be grouped under the INCI designation »perfume«. The only exception is for 26 particularly allergenic substances, which manufacturers must declare by name above a certain level.

It is under discussion to extend the list to further fragrances. For customers who are sensitive to fragrances, the PTA can recommend fragrance-free alternatives. A good recommendation are products with the DAAB logo, which contain neither fragrances nor allergenic preservatives, or natural cosmetics, for example from Lavera, Dr. Hauschka, Weleda, Primavera or Speick.


Deutsch/German Englisch/English
Allergene allergens
Alternativen alternatives
Bläschenbildung blistering, vesiculation
Duftstoffe perfumes, scents
Einstufung classification, designation
Entzündung inflammation
Hautreizungen skin irritations
Hersteller manufacturer
Inhaltsstoffe ingredients
Juckreiz itching
Karzinogen carcinogenic
Kategorien categories
Konservierungsstoffe preservatives
Kosmetik cosmetics
Kosmetikverordnung Cosmetics Regulation
Mutagen mutagenic
Naturkosmetik natural cosmetics
Reproduktionstoxisch toxic to reproduction
Stoffe substances
Substanzen substances

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