Endocrine active substances (EAS) are used in cosmetics mainly as preservatives and UV filters. Cosmetic products (such as sunscreen, shower gel, perfume) are also suspected of containing endocrine disrupting substances: e.g. UV filters in sunscreens (benzophenones and ethylhexyl methoxycinnamates), preservatives in creams (parabens), hair dyes (resorcinol), conditioners (cyclotetrasiloxane) or denaturants in alcohol (diethyl phthalate).
Safety of cosmetics with endocrine active substances
All cosmetic products must be safe. The manufacturer must be able to demonstrate the safety of his cosmetic product in a safety report.
There is no general approval for cosmetic products in the EU. However, certain ingredients such as preservatives, colorants or UV filters must be approved. The approval procedure for these substances is regulated at European level. The basis for approval is a risk assessment by the Scientific Committee for Consumer Protection on Consumer Products (SCCS). The approved substances are included in a positive list. This may also contain restrictions on use, e.g. maximum concentration levels.
The SCCS scientific committee also evaluates substances that have already been permitted if new scientific findings become available (re-evaluation). Based on such scientific evaluations, new limits, bans or other restrictions can be established for substances.
Important preservatives in cosmetics are parabens. They are considered to be effective and skin-friendly. From studies with animals it became known that some parabens can influence the hormone system. Based on scientific assessments by the SCCS Committee, the European Commission has regulated the use of certain parabens as follows:
- Methyl and ethyl parabens are considered safe: based on new data, their safe use in cosmetic products has been reconfirmed.
- Benzylparaben, phenylparaben, pentylparaben, isobutylparaben and isopropylparaben: their use was banned throughout the EU due to insufficient data. Since 30.07.2015, products containing these preservatives may no longer be made available on the market (according to VO 358/2014).
- For propyl and butyl paraben: the use concentration has been reduced or the use in products for children under 3 years of age in the diaper area has been prohibited (according to the VO 1004/2014).
In the European Union, endocrine disruptors are to be specifically regulated in various legal areas. In the area of plant protection products and biocides, the European Commission has established criteria for the identification of endocrine disruptors, which are based on the WHO definition. Although these criteria are not binding for cosmetic products, they must nevertheless be taken into account.
According to Cosmetics Regulation (EC) No. 1223/2009, the EU Commission must review the Cosmetics Regulation with regard to substances with endocrine disrupting properties when recognized criteria for the identification of substances with endocrine disrupting properties are available. As a first step, the Commission has published a document for this purpose, which sets out the form in which endocrine disruptors can currently be regulated under the Cosmetics Regulation or REACH. Substances that may pose a risk to human health are regulated on the basis of a scientific assessment (SCCS). The Commission has submitted a priority list of potential endocrine disruptors to the SCCS for evaluation. Some of these substances have already been evaluated, while for others this evaluation is still pending.
Formore information on endocrine dis ruptors, see the European Commission's page on cosmetics.
In cosmetics, nanomaterials are mainly used as encapsulation or carrier systems to transport active ingredients into deeper skin layers. They are also used as optimized UV protection filters in sunscreens.
In terms of the EU Cosmetics Regulation, a nanomaterial is an insoluble or biologically stable and intentionally manufactured material with one or more external dimensions or an internal structure in the range of 1 to 100 nanometers.
However, as there are different definitions of nanomaterial at the EU level, an adaptation of the individual definitions is currently still under discussion.
In addition to notification, cosmetic products containing nanomaterials must be notified by the responsible person to the European Commission via the"Cosmetic Products Notification Portal (CPNP)" six months before they are placed on the market. This must include the specifications (size, physical and chemical properties), a toxicological profile, safety data and exposure conditions of the nanomaterial(Questions and answers on the notification of cosmetic products containing nanomaterials).
All ingredients in the form of nanomaterials must be clearly listed in the list of ingredients. The names of these ingredients must be followed by the word "nano" in parentheses. Nanomaterials that have already been classified as safe by the European Commission and are mentioned in the annexes of the regulation as colorants, UV filters or preservatives do not have to be notified before being placed on the market. However, labeling as "nano" must still be done.
Information on nanomaterials can be found on the European Commission's page on cosmetics.
CMR substances (Art. 15) are substances that: are carcinogenic (carcinogenic), mutagenic (mutagenic) or toxic for reproduction (toxic for reproduction) or are suspected of having such effects. Substances classified as CMR substances in accordance with Regulation (EC) No. 1272/2008 are generally prohibited. They are classified into hazard categories according to their toxicity:
Category 1A or 1B
A category 1A or 1B substance may be used in cosmetic products in exceptional cases if all of the following criteria are met:
- the food safety requirements of Regulation (EC) No 178/2002 are met
- there are no suitable substitutes
- it concerns a specific use with known exposure
- it has been assessed as safe by the SCCS
A category 2 substance can be used in cosmetic products if it has been found safe by the Scientific Committee on Consumer Safety (SCCS).
For better clarity, since 2019 the Commission has decided to include substances that have been classified as CMR substances according to Regulation (EC) No 1272/2008 (Part 3 of Annex VI) and that do not meet the exemption conditions of the Cosmetics Regulation (Article 15) in Annex II (Prohibited List) and, if necessary, to delete them from the other annexes. This is regularly done with the so-called "Omnibus Acts". All "Omnibus-Acts" and further amendments to the Regulation can be found here.
Further information on CMR substances can be found on the page of the European Commission on cosmetics.
Peeling is a cosmetic or dermatological procedure designed to remove the top layers of the skin, depending on the type and concentration. The aim is to stimulate the formation of new cells and make the skin look fresher and smoother. On the one hand, a distinction is made between mechanical and chemical peeling, and on the other hand, the depth of peeling is differentiated into superficial, medium and deep peeling.
In mechanical peeling, the uppermost layers of the skin are removed by rubbing - this usually leads to a slight reddening and irritation of the skin, which, however, soon subsides. Fine quartz sand, ground seeds of fruits (apricots) or even solid plastic (polyurethane) or water-soluble salts (NaCl) are used.
Chemical peeling uses chemical stimuli to remove the top layer of skin. Depending on the desired depth of effect of the peeling, various chemical acids are used, such as vitamin A acid, trichloroacetic acid, phenolic compounds and fruit acids. Fruit acids are hydroxycarboxylic acids often found in fruits, mostly α-hydroxy acids (AHA) such as malic acid, citric acid, gluconic acid, glycolic acid, mandelic acid, lactic acid, α-hydroxycaprylic acid and tartaric acid.
Classification as cosmetic product
It should be noted that not all peeling products are cosmetic products. In the Borderline Manual (September 2020, version 5.2), this delimitation is dealt with under point 3.4.1:
Depending on all characteristics especially the composition, intended purpose and depth of the peel, it must be assessed how the peel affects normal skin physiology and barrier function. Cosmetic products may remove dead cells and the uppermost layers of the stratum corneum, provided they do not significantly affect normal skin physiology and barrier function. Peels that expose deeper layers of the stratum corneum or result in complete removal of the stratum corneum significantly impact skin physiology and barrier function. Such a product cannot be considered a cosmetic product.
Further information on Borderline Manual can be found under Differentiation from cosmetic products.
Recommendations for the use of fruit acid
Vitamin A acid (retinoic acid) is used as an active pharmaceutical ingredient in the treatment of acne and hyperkeratotic skin diseases (severe keratinization) and is banned in cosmetic products.
In 1997, the Cosmetic Ingredients Review (CIR) evaluated the safety of lactic acid and glycolic acid. The panel concluded that products for general use containing up to 10% fruit acid (lactic acid or glycolic acid) at a pH greater than 3.5 are considered safe. It must be ensured that the formulation does not increase sun sensitivity or has application instructions that include daily sun protection. For professional users, the panel concluded that the threshold is 30% at a pH greater than 3.0.
The former EU Scientific Committee (SCCNFP) evaluated α-hydroxy acids and thus glycolic and lactic acids in its position paper. According to this, taking into account the precautionary principle, the content of lactic acid in cosmetic products should not exceed 2.5 % and glycolic acid should not exceed 4 %, with pH values greater than 5 and 3.8, respectively. Furthermore, warnings should ensure that contact with the eyes is prevented and that UV exposure is minimized during treatment (until the skin layers have regenerated).
Last updated: 22.01.2022