Annexes II, III and V of the Cosmetics Regulation (EC) No 1223/2009 have been updated with several new substances. This means that the list of substances restricted in cosmetic products for reasons of safety and suitability has been updated. The Annexes now include a total of 996 substances with limits on their concentrations in finished cosmetic products.

Therefore, if you manufacture or import cosmetics, you will be affected by these updates. The rest of this article will give more information about the changes and what they mean to manufacturers and importers.

What are the changes to the Annexes? 

The updates to Annexes II, III, and V affect the following substances:

  • Certain metal compounds (chromium, cobalt, copper, manganese)
  • Carbon disulfide
  • Nonylphenol polyethoxylated
  • Substances for which the level of safety has not yet been assessed because there is insufficient evidence

These changes mean that certain substances are now permitted in products. For instance, the use of chromium salts as colorants or preservatives is no longer banned. This change could lead to an increase in the use of chromium salts in products. The same applies to manganese, cobalt, and copper. While these amendments were made to Annex II on individual limits, Annex III has also been updated with new limits for carbon disulfide. This means that it will now be allowed in cosmetic products at a maximum concentration of 0.2%. Previously it was banned altogether.

Who is affected by these changes?

The changes introduced by the new Annexes II, III, and V of the Cosmetics Regulation (EC) No 1223/2009 affect manufacturers and importers.

Manufacturers are those who take raw materials and make their cosmetic products. Importers are those who import cosmetics from outside the EU to sell inside it.

The updates introduce limits on the concentrations of 996 substances in finished cosmetic products, which means that manufacturers will have to ensure that these limits are met before they can put their products on the market. Importers will also need to make sure that their suppliers comply with these limits, as well as other restrictions on substances in cosmetics.

If you manufacture or import cosmetics, you will be affected by these updates.

What substances have been added to Annexes II, III, and V?

In Annex II, III, and V, the following substances have been added:

  • Substances that can cause reproductive toxicity, such as di(2-Ethylhexyl) phthalate (DEHP), polycyclic musks, nitro musks, or lead.
  • Substances that can trigger allergic reactions such as triclosan, cinnamaldehyde, and benzophenone-3.
  • Substances that are prohibited in cosmetic products for reasons of safety and suitability such as alkylphenols and hexachlorobenzene.

Conclusion

The European Commission has considered the well-being of Europeans by updating Annexes II, III, and V of the Cosmetics Regulation (EC) No 1223/2009. The updates will be applied to all cosmetic products in Europe, but also cosmetic products imported from third countries.

A total of 996 substances are now included in the three restricted lists. Manufacturers and importers to stay aware of these changes because they could affect their production or importing process.