The beginning of the New Year is a time of summaries, resolutions and changes, including those in cosmetic regulations. What changes in the cosmetics law will 2020 bring us? You can find it out from the below post 🙂
- Salicylic Acid as hot potato topic
On November 27th, 2019, Commission Regulation (EU) No. 2019/1966 introducing amendments to the Regulation 1223/2009 appeared. These changes largely concern the conditions of Salicylic Acid use in cosmetics.
Salicylic Acid, 2-hydroxybenzoic acid, belongs to the group of β-hydroxy acids (BHA) and occurs in the nature, including in willow bark and chamomile flowers. It is widely used in cosmetics as a preservative, keratolytic, anti-dandruff, masking, skin and hair conditioning agent.
Salicylic Acid is included both in the list of substances which cosmetic products must not contain except subject to the restrictions laid down (Annex III of the Regulation 1223/2009 – position 98) and on the list of allowed preservatives (Annex V, position 3, Salicylic Acid and its salts).
Classification of Salicylic Acid as a CMR (carcinogenic, mutagenic or toxic for reproduction) substance category 2, in accordance with the Regulation No. 1272/2008/EC (CLP), forced changes regarding the conditions of use of this substance in cosmetics. Category 2 CMRs are substances that are suspected to be carcinogenic to humans. Should therefore Salicylic Acid be on the list of banned substances in cosmetics (Annex II)? Not completely. Salicylic Acid meets the conditions described in the Article 15 of the Regulation 1223/2009, i.e.:
- it was assessed by the Scientific Committee on Consumer Safety (SCCS),
- SCCS found Salicylic Acid safe for use in cosmetic products.
Therefore, the SCCS Committee supported the safety of Salicylic Acid in its opinion no. SCCS/1601/18. The safety of the acid has been confirmed in applications other than as a preservative while maintaining the existing restrictions and concentrations, i.e. in rinse-off hair products at a maximum concentration = 3.0% and in other products at a concentration not exceeding 2.0%, except for body lotions, eye shadows, mascaras, eyeliners, lipsticks and roll-on deodorants. The SCCS opinion does not apply to oral products or spray products that may lead to exposure through inhalation. In addition, the SCCS Committee concluded that Salicylic Acid is irritating to the eyes and may potentially cause serious eye damage.
Considering the above properties of Salicylic Acid and the SCCS opinion, new restrictions of the acid use have been introduced, described in the Annex III, position 98 (uses other than as a preservative). Therefore, Salicylic Acid cannot be used in the following products:
- body lotions, eye shadows, mascaras, eyeliners, lipsticks and roll-on deodorants,
- ANY products for children under 3 years old (until now the use of acid in shampoos for children under 3 years of age has been allowed),
- products that may lead to exposure of the user’s lungs via inhalation (e.g. spray cosmetics),
- oral care cosmetics.
Changes have also been made to the Annex V (position 3 – use of Salicylic Acid as a preservative). Here also the current maximum concentration (0.5% as acid) and conditions of use have been maintained, however, new restrictions, similar to those from the Annex III, have been added:
- not to be used in products for children under 3 years of age (in any products, the use of acid in shampoos for children under 3 years of age has been allowed so far),
- not to be used in oral products,
- not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation.
The above changes regarding Salicylic Acid will come into force on May 1st, 2020.
In the opinion SCCS/1601/18 it was also noted that studies are currently underway on the potential for endocrine disrupting of Salicylic Acid. The results of these studies may be significant for further restrictions on the use of Salicylic Acid in cosmetics. So, the time will tell us how the further history of Salicylic Acid in the cosmetics industry will unfold…
- New prohibited substances
Changes will also take place in the Annex II (list of prohibited substances in cosmetic products). Here, due to the aforementioned CLP Regulation, compounds classified as CMR must be included in the list of prohibited substances. Annex II will therefore be extended by another 30 compounds and will already contain 1641 items. New banned substances will include: Phosmet, Potassium permanganate, Propiconazole, Tetramethrin, 1-Vinylimidazole, Phenol, dodecyl-, branched, Acetochlor, Glass microfibres of representative composition, Dicyclohexyl phthalate and tert-Butyl hydroperoxide.
Some of these substances are already prohibited from December 18th, 2019, while others will be banned from May 1st, 2020.
As it can be seen, there is a tendency to systematically include subsequent CMR substances in the list of prohibited substances of the Regulation 1223/2009. Due to the classification of Salicylic Acid as a CMR substance, it was necessary to collect data from new studies, waiting for the opinion of SCCS, and then implement further restrictions under the conditions of use of this compound in cosmetics. We already know about such significant changes in the cosmetics law at the very beginning of the new year 2020. I wonder what will be the next ones and what this year will bring for the cosmetics sector 🙂
Link to the website with the Regulation: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32019R1966&from=EN
Link to the website with SCCS opinions concerning Salicylic Acid: https://ec.europa.eu/health/sites/health/files/scientific_committees/consumer_safety/docs/sccs_o_223.pdf