Made in the EU: What European Cosmetics Rules Mean for You

Made in the EU: What European Cosmetics Rules Mean for You

Short answer: The EU Cosmetics Regulation, (EC) No 1223/2009, is one rulebook for every cosmetic sold in the European Union. Each product needs a named Responsible Person in the EU, a written safety assessment, a full ingredient list in standard INCI names, and no animal testing for cosmetic purposes. The same rules cover imports.

Quick facts

Question Answer
Which law? Regulation (EC) No 1223/2009, applied in full across the EU since 2013
Who is accountable? A Responsible Person based in the EU, named on every pack
Is each product checked for safety? Yes, by a qualified safety assessor, before it goes on sale
Is animal testing allowed? No, not for cosmetic purposes, and products tested that way cannot be sold
Does a regulator approve each product? No. Products are notified, not pre-approved; responsibility sits with the company

What is the EU Cosmetics Regulation?

It is a single law that sets the safety, ingredient, labelling and claims rules for cosmetics across all EU member states. Before it, each country had its own national rules built on an older directive. A regulation applies directly in every member state, so a face cream sold in Hannover, Lisbon or Helsinki meets the same requirements.

A "cosmetic" in this law means a product applied to the outer parts of the body, the teeth or the mouth to clean, perfume, change the appearance, protect, keep in good condition or correct body odours. That definition is the reason cosmetics speak the language of look and feel. A product presented as treating or preventing disease, or as changing how the body functions, risks being classed as a medicine instead.

What is a Responsible Person, and why does it matter?

The Responsible Person is the company or individual in the EU that answers for a product's compliance. Every cosmetic placed on the EU market must have one, and their name and address must appear on the label. They make sure the safety assessment exists, the product information file is kept, the label is correct and any serious reactions are reported to the authorities.

For you, this means there is always a named, reachable party inside the EU behind a product. If a product came from a seller with no EU address on the pack, that is a reason for caution.

A distributor has duties too. Before selling, a distributor must check that the label information is present, that the date of minimum durability, where one applies, has not passed, and that storage and transport do not harm the product. L'ESTHETIQ products are made in the EU, and Med24 GmbH in Hannover is the distributor.

What does the safety assessment cover?

Every cosmetic needs a written cosmetic product safety report before it goes on sale. A qualified safety assessor reviews the formula as a whole, the toxicological profile of each ingredient, the likely exposure from normal use, stability, microbiological quality, impurities and the packaging. The report sits inside a product information file, which the Responsible Person must keep available for the authorities for ten years after the last batch is placed on the market.

The product must also be made under good manufacturing practice, and it must be notified through the EU's Cosmetic Products Notification Portal before sale, which gives authorities and poison centres access to key information.

Which ingredients are banned or restricted?

The regulation keeps lists, called annexes, of what may and may not go into a cosmetic.

  • Annex II lists prohibited substances.
  • Annex III lists restricted substances, with limits on where and how much they may be used, and any warnings needed.
  • Annexes IV, V and VI list the only colourants, preservatives and UV filters allowed.

These lists are updated as the science changes. One recent example concerns kojic acid: a 2024 amendment, Commission Regulation (EU) 2024/996, restricted it to face and hand products. That is why our Brightening Face Exfoliator with Kojic Acid is labelled for the face and hands and not for the body.

What must a cosmetic label show?

The regulation sets a fixed list of information, so you can compare any two products on the same terms.

Label item What it tells you
Responsible Person's name and address Who answers for the product in the EU
Nominal content (ml or g) How much is in the pack
Date of minimum durability or the open-jar symbol How long it keeps unopened, or after opening
Precautions for use Warnings that must accompany certain ingredients
Batch number Which production run the pack came from
Function, unless obvious What the product is for
Ingredient list in INCI names Everything in the formula, in descending order of weight; those under 1% may follow in any order

The ingredient list follows strict rules. Ingredients present above 1% are listed in descending order of weight; those below 1% may follow in any order. Fragrance appears as "parfum", and certain fragrance allergens must be named individually above set thresholds. Nanomaterials are marked "(nano)". The names are INCI names, an international system that mixes Latin plant names with English chemical names, so "Aqua" and "Butyrospermum Parkii Butter" read the same in every country.

Is animal testing banned for cosmetics in the EU?

Yes. The regulation bans animal testing of finished cosmetic products and of cosmetic ingredients to meet its requirements, and it bans selling cosmetics whose ingredients were tested on animals for that purpose. The final stage of the marketing ban took effect in 2013. One honest nuance: other EU chemicals laws, which cover workers and the environment, can still require data on some substances that are also used in cosmetics. That overlap is a long-running debate, and it is the reason careful brands phrase their animal-testing statements precisely.

How are cosmetic claims regulated?

A separate regulation, (EU) No 655/2013, sets six common criteria that every cosmetic claim must meet: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making. A claim must not suggest a product does more than the evidence shows, and it must not present a legal requirement as if it were a special feature. This is why you will read "helps skin look smoother" on our pages, and why you will not find promises to change how skin works.

What "made in the EU" does and doesn't tell you

It tells you where a product was manufactured, and nothing more. Imported cosmetics sold in the EU must meet the same safety, ingredient and labelling rules as those made here. "Made in the EU" does not mean natural, vegan, fragrance-free or suitable for your skin. Those are separate questions, answered by the ingredient list and any certification logos. For example, our Exosome & Niacinamide Serum is fragrance-free because its formula contains no added fragrance, not because of where it was made.

What EU rules won't do

  • They do not pre-approve products. No authority signs off each cream before sale. Notification and the safety report are the company's responsibility, checked by market surveillance afterwards.
  • They do not define "natural" or "clean". Those words have no legal definition in the regulation. Private standards such as COSMOS set their own criteria.
  • They do not promise a product suits you. A product can be safe for general use and still disagree with your skin. Patch test new products.
  • They do not rank products. Meeting the rules is the floor, not a mark of quality.

Frequently asked questions

Who is the Responsible Person for a cosmetic?

It is the company or person in the EU legally accountable for the product's compliance. Their name and address must be on the label. For a product made in the EU, it is often the manufacturer or the brand owner.

Are cosmetics approved before they go on sale in the EU?

No. There is no pre-market approval for each product. Instead, the Responsible Person must hold a safety report and product information file and notify the product through the EU portal, and authorities can inspect at any time.

Is animal testing banned for cosmetics in the EU?

Yes, for cosmetic purposes. Testing finished products and ingredients to meet the Cosmetics Regulation is banned, and so is selling cosmetics tested that way. Other chemicals laws can still require data on some ingredients for worker or environmental safety.

Does "made in the EU" mean a product is natural or vegan?

No. It only describes where the product was made. Check the ingredient list and any certification marks. For our range, 12 of 13 products are vegan; the Keratin hair mask is not, as it contains hydrolysed keratin.

What should I do if a cosmetic causes a reaction?

Stop using it and see a doctor if the reaction is more than mild and short-lived. Tell the seller or the Responsible Person named on the pack, and keep the packaging with its batch number so the product can be traced.

To see how these rules look on real packs, browse our face care collection or read the FAQ.

Last reviewed: October 2026.

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