How to interpret the Regulation (EC) No. 1223/2009?

What are the Annexes to Regulation 1223/2009?

The annexes act as “reference lists” that define which substances may — or may not — be used in cosmetics, and under what conditions. The main ones are:

• Annex II – Restricted prohibited in cosmetics.

• Annex III – Restricted substances: prohibited substances that may only be used within specific concentrations or conditions.

• Annex IV – List of permitted colourants..

• Annex V – List of permitted preservatives.

• Annex VI – List of permitted UV filters..

Being able to consult these lists is essential when assessing raw materials and formulations.

Interpreting the annexes requires careful attention to a few aspects:

• Complex chemical names or derivatives (e.g. salts, esters).

• Conditions of use and mandatory warnings.

• Common updates published by the European Commission.

• Ingredients of complex composition, such as fragrances and plant extracts.

These details make the difference between a compliant and a non-compliant product. In addition to ensuring consumer safety, they also safeguard the credibility and legality of your brand.

At Pharmilab, we help transform regulatory complexity into clarity and confidence. If you have questions about the annexes of Regulation 1223/2009, get in touch with us—we are ready to support your team.