EU Regulation 1223/2009
Definition
The EU Cosmetics Regulation: the primary legal framework governing cosmetics marketed in the EU. Annex II (prohibited substances) lists lead (Entry 209), mercury (Entry 221), and antimony (Entry 35). Annex IV lists permitted colourants; unlisted colourants including Sudan dyes and Rhodamine B are prohibited by default. Annex V lists permitted preservatives including FRPs with maximum concentrations.
- Common name
- EU Cosmetics Regulation
- Annex II
- Prohibited substances, including lead and mercury
- Annex IV
- Permitted colourants list
- Annex V
- Permitted preservatives, including maximum concentrations
Common questions
Why are Sudan dyes and Rhodamine B prohibited by default under this Regulation?+
Annex IV operates as a positive list, so any colourant not explicitly listed as permitted is prohibited, and Sudan dyes and Rhodamine B were never added, which is why their presence in a cosmetic sample is treated as a clear regulatory violation rather than requiring a separate ban entry.
How does a forensic chemist use the Annex II entry numbers in casework?+
The numbered entries, such as Entry 209 for lead, give a fixed reference point for reporting which specific prohibited substance a sample tested positive for, keeping the finding tied to the exact regulatory listing rather than a general description.
What does exceeding an Annex V preservative limit mean for a cosmetic product?+
It means the product contains a permitted ingredient, such as a formaldehyde releaser, above its allowed maximum concentration, which is a distinct violation from using a banned substance outright and is assessed against the specific concentration cap in the annex.
Related terms
- Ammoniated Mercury
- A mercury-ammonia complex (mercuric chloride-ammonia, HgNH2Cl) historically used as a skin-lightening active ingredient. Inhibits melanogenesis by binding to tyrosinase's active-site cysteine. Causes...
- Formaldehyde-Releasing Preservative (FRP)
- A preservative that slowly releases formaldehyde as its antimicrobial active ingredient. The five principal FRPs in cosmetics are quaternium-15, DMDM hydantoin, imidazolidinyl...
- Galena (PbS)
- Lead(II) sulfide: the principal ore of lead, a grey-black metallic mineral used as the traditional pigment in kohl eye cosmetics for thousands...
- Kohl (Kajal, Surma, Al-Kohl)
- A dark powder applied to the eyes as a cosmetic in South Asian and Middle Eastern cultural traditions. Traditional mineral kohl is...
- MoCRA 2022
- Modernization of Cosmetics Regulation Act 2022 (US), signed into law December 2022. Requires cosmetic-facility registration with FDA, product listing, safety substantiation, adverse-event...
- Nash Reagent Method
- The EU reference colorimetric method for free formaldehyde in cosmetics: formaldehyde reacts with ammonium acetate and acetylacetone to produce the yellow 3,5-diacetyl-1,4-dihydrolutidine...
- RAPEX / Safety Gate
- The EU rapid alert system for dangerous non-food consumer products, including cosmetics. Analogous to RASFF for food. Member states notify dangerous products;...
- Rhodamine B
- A xanthene dye (C28H31ClN2O3, MW 479.0) with brilliant pink fluorescence, listed on the EU REACH SVHC candidate list as a suspected carcinogen...
- Tyrosinase Inhibition
- The mechanism by which mercury compounds and some other skin-lightening agents achieve depigmentation: mercury binds to the sulphydryl (cysteine) group at the...