EU Cosmetics Regulation 1223/2009: who has to do what.
Regulation (EC) No 1223/2009 sets the rules for every cosmetic product sold in the EU. Great Britain keeps its own version of the same text, and Türkiye’s Cosmetic Products Regulation is built on it. This guide covers who carries which duty, what the annexes list, what the label must say, and how changes reach you.
01/Obligations
Who carries which duty? Mostly the Responsible Person.
Article 5 lists the articles the Responsible Person must comply with. Almost every duty in the Regulation lands on that one person.
| Article | What it asks for |
|---|---|
| Article 4(1) | A Responsible Person established in the EU for every product. Nothing is placed on the market without one. |
| Article 3 | The product is safe under normal or reasonably foreseeable use. |
| Article 10(1) | A safety assessment and a cosmetic product safety report before the product is placed on the market. |
| Article 11(1) | A product information file for every product, kept ten years after the last batch. |
| Article 13(1) | Notification before placing on the market, through the CPNP. |
| Article 14(1) | No prohibited substances, and restricted ones only within the limits of the annexes. |
| Article 19(1) | The label carries the information the article lists, in indelible, easily legible and visible lettering. |
| Article 20(1) | No claim implying characteristics or functions the product does not have. |
| Article 23(1) | Serious undesirable effects reported without delay to the authority (cosmetovigilance). |
Great Britain applies the same structure through its own Article 4: the Responsible Person must be established in the UK, and products are notified through SCPN instead of the CPNP. Northern Ireland has a separate process.
02/Annexes II–VI
Five annexes, one list each.
Article 14 points to five lists. One prohibits, one restricts, and three allow only what they name: colorants, preservatives and UV filters.
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Annex II · Prohibited substances
- What it lists
- Substances prohibited in cosmetic products
- In Unique Alphabet®
- Regulations: search by ingredient, number or product type
-
Annex III · Restricted substances
- What it lists
- Substances allowed only within the restrictions laid down: limits, product types, wording
- In Unique Alphabet®
- Formula Check compares each ingredient with its annex limit
-
Annex IV · Colorants
- What it lists
- Colorants allowed in cosmetic products, with their conditions
- In Unique Alphabet®
- Each entry and its conditions, shown as written
-
Annex V · Preservatives
- What it lists
- Preservatives allowed in cosmetic products, with maximum concentrations
- In Unique Alphabet®
- Each limit and its mandatory wording, shown as written
-
Annex VI · UV filters
- What it lists
- UV filters allowed in cosmetic products, with their conditions and warnings
- In Unique Alphabet®
- Each limit and its mandatory warning, shown as written
03/Labelling
What must the label say? Seven items.
Article 19(1) lists what the container and packaging must carry. The language of most items is set by the Member State where the product is sold.
Responsible Person
Name or registered name and address; the country of origin for imported products.
Nominal content
By weight or by volume, except under five grams or five millilitres, free samples and single-application packs.
Date of minimum durability
Or, for products lasting more than 30 months, the period after opening (the open-jar symbol).
Precautions
Particular precautions for use, and at least those listed in Annexes III to VI.
Batch number
Or the reference that identifies the product.
Function
Unless it is clear from the presentation.
List of ingredients
Headed “ingredients”, in descending order of weight, using common INCI names; nanomaterials followed by “(nano)”.
Claims sit under Article 20: whatever the label implies, the product has to deliver, and the evidence goes into the product information file.
04/Changes
How do changes reach you? Through the annexes.
The Regulation itself rarely changes; the annexes do, through amending regulations with their own dates. A limit that tightens can take a product you already sell off the market.
Every change to the EU, UK and Türkiye annexes, dated, with its source.
Regulatory Watch reads EU, UK and Türkiye sources and names the product a change touches.
Türkiye’s regulation is itself a change in the log: Resmî Gazete 32184, in force since 8 November 2023.
Questions about the Regulation.
What is Regulation (EC) No 1223/2009?
The EU regulation on cosmetic products. It sets who is responsible for a product, how its safety is assessed and documented, how it is notified and labelled, and which substances are prohibited, restricted or allowed.
Does it still apply in the UK?
Great Britain keeps its own version of the Regulation, with a Responsible Person established in the UK and notification through SCPN. Northern Ireland has a separate process.
Do cosmetics need approval before sale?
No. There is no pre-market approval. The Responsible Person carries out the safety assessment, keeps the product information file and notifies the product before placing it on the market.
What is the difference between Annex II and Annex III?
Annex II lists substances cosmetic products must not contain. Annex III lists substances they may contain only within the restrictions it lays down.
How often does Regulatory Watch check for changes?
Once a day, overnight, across every source it reads.
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