Amendments to the Regulation 1223/2009

On June 12, Commission Regulation (EU) No 2019/831 /EU of 22 May 2019 entered into force amending Annexes II, III and V to the Regulation 1223/2009.

What has changed?

  • First of all, the Regulation takes into account compounds classified as CMR substances (carcinogenic, mutagenic or toxic to reproduction) in accordance with the Regulation No. 1272/2008 /EC (CLP) of 1st December 2018.
  • In connection with the above, the list of prohibited substances in cosmetic products has significantly increased (Annex II). Formaldehyde, Dichloromethane and Quaternium-15 has appeared, among others, on the list, which were classified as CMR substances, and a number of other compounds, e.g. Methylene Glycol, Styrene, Octamethylcyclotetrasiloxane (D4) and Acetaldehyde. The previous version of the list of prohibited substances included 1384 compounds, currently we have as many as 1611 of them.
  • From the Annex III (the list of substances which cosmetic products must not contain except subject to the restrictions laid down) some compounds have been deleted and transferred to the Annex II (the list of prohibited substances). Why? Because some of them have been classified as CMR substances. Taking into account this fact and other factors concerning toxicological and safety data, it was found that these compounds should be banned in cosmetic products. Among these substances, e.g. already mentioned Formaldehyde or Dichloromethane has appeared. Also Boric Acid and Tetraborates have been removed from the Annex III.
  • In the Annex V (the list of allowed preservatives), similar changes have occurred as above. Previously allowed preservatives, subsequently classified as CMR substances have now been banned, therefore, they have been transferred from the Annex V to the Annex II. What are those substances? Of course, Formaldehyde, as well as Quaternium-15 and Chloroacetamide. Also Chlorophene has disappeared from the list of allowed preservatives, and the maximum allowable concentration for Polyaminopropyl biguanide has been reduced from 0.3% to 0.1% and the possibility of its use in products with inhalation exposure has been excluded.

As you can see, there are a lot of changes. The regulation entered into force on June 12, 2019. This is the final date of withdrawal from the market of products containing ingredients added to the Annex II of the Regulation 1223/2009.

The Regulation can be read at the following link:

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