Amendments to Annexes II, III and V to Regulation (EC) No 1223/2009
Substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) of category 1A, category 1B or category 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CMR substances) are prohibited for use in cosmetics (Article 15 of Regulation EC) No 1223/2009).
Nevertheless, a CMR substance may be used in cosmetics if it complies with the conditions set out in Article 15 (1) or the second subparagraph of Article 15 (2) of Regulation (EC) No 1223/2009.
Substances prohibited for use in cosmetic products
CMR substances, which haven’t complied with the requirements for restricted use in cosmetics laid down in Regulation (EC) No 1223/2009, are added to the list of prohibited substances in Annex II to Regulation (EC) No 1223/2009. This includes Quaternium-15, Chloroacetamide, Dichloromethane, Formaldehyde, Perboric acid and Sodium perborate compounds.
Quaternium-15
Quaternium-15 is currently listed in Annex V to Regulation (EC) No 1223/2009 and is allowed for use in cosmetic products in a concentration of up to 0,2 %. The substance is a mixture of cis and trans isomers, of which the cis-isomer is a CMR substance of category 2. Furthermore, the Scientific Committee on Consumer Safety (SCCS) concluded that the safety of Quaternium-15 cannot be established. Therefore, this substance has been added to the list of substances in Annex II to the Regulation (EC) No 1223/2009 and deleted from Annex V to the same Regulation.
Chloroacetamide
Chloroacetamide is currently included in Annex V to Regulation (EC) No 1223/2009 as allowed for use in cosmetic product in a concentration of up to 0,3 %. This substance has been classified as a CMR substance of category 2. It was concluded by the SCCS that chloroacetamide is not safe for use in cosmetics when used according to the currently allowed concentration. The substance has been deleted from the list of preservatives allowed in cosmetics and added to the list of prohibited substances for use in cosmetic products.
Dichloromethane
Dichloromethane is included in Annex III to Regulation (EC) 1223/2009 and is allowed for use in a concentration of up to 35 % in ready for use preparations. It has been classified as a CMR substance of category 2. In addition, the SCCS has established that dichloromethane used in a concentration of up to 35 % in spray formulations, including hair sprays, is not considered safe. Therefore, this substance has been deleted from the list of restricted substances (Annex III) and added to the list of prohibited substances (Annex II).
Formaldehyde
Formaldehyde is currently allowed in nail hardening in a concentration of up to 5 % and is listed in Annex III. In addition, it can also be found in Annex V as allowed in oral products in a concentration of up to 0,1 % and in other cosmetic products, when used in a concentration of up to 0,2 %. Formaldehyde is a CMR substance of category 1B. CMR substances may be used in cosmetics if, among other requirements, no suitable alternatives are available. It has not been established that there are no suitable alternative substances available for the purpose of hardening nails, therefore, formaldehyde has been deleted from the list of restricted substances in Annex III. Additionally, since no application was made for other uses of formaldehyde, it has also been deleted from Annex V and added to the list of prohibited substances in Annex II.
Perboric acid and Sodium perborate compounds
These substances are CMR substances of category 1B and are covered by the hydrogen peroxide releasing substances listed in Annex III. It has not been established that there are no suitable alternatives available for the purpose of oxidation of hair. Therefore, Perboric acid and Sodium perborate compounds have been deleted from the list of restricted substances and added to the list of prohibited substances.
Dibutyltin hydrogen borate and boron compounds
Dibutyltin hydrogen borate and some boron compounds, which are currently included in entries 1a and 1b of Annex III, have been classified as CMR substances of category 1B. Those boron compounds have been deleted from Annex III and added to the list of prohibited substances in Annex II, together with Dibutyltin hydrogen borate.
Other substances prohibited for use in cosmetics
Substances, which are not classified as CMR substances, but are chemically similar to substances classified as CMR substances, have also been added to the list of prohibited substances in Annex II. This includes Paraformaldehyde, Methylene Glycol and certain boron compounds (borates, tetraborates, octaborates, boric acid salts and esters such as MEA-borate, MIPA-borate, potassium borate, trioctyldodecyl borate and zinc borate).
Substances restricted for use in cosmetic products
Furfural, Trimethylbenzoyl diphenylphosphine oxide and Polyaminopropyl biguanide, have fulfilled the conditions for restricted use in cosmetics laid down in Regulation (EC) No 1223/2009. This means, they are allowed for use in cosmetic products.
Furfural
Furfural, which has been classified as a CMR substance of category 2, is used as a fragrance or flavour ingredient in cosmetics. It is currently not listed in any of the Annexes, but it has now been added to Annex III with a maximum allowed concentration of 0,001 %
Trimethylbenzoyl diphenylphosphine oxide (TPO)
TPO is currently not included in the Annexes but has been added to the list of restricted substances in Annex III. It may be used in artificial nail systems for professional use only with a maximum concentration of 5 %.
Polyaminopropyl biguanide
This substance is currently included in Annex V and may be used in a concentration of up to 0,3 %. Based on the SCCS opinion concerning the safety of polyaminopropyl biguanide, it is allowed for use as a preservative in cosmetics with a concentration of up to 0,1 %, except in applications that may lead to exposure of the end-user’s lungs by inhalation.