Everything you need to know about cosmetics compliance and the cosmetics regulation (2024)

If you want to sell or manufacture cosmetic products it is important that you make yourself familiar with the cosmetics law and legislation. Here you can read all the essential information.

Cosmetic legislation and the cosmetics regulation

In Europe there are strict rules for putting cosmetic products on the EU market, and this is a good thing. When you want to produce or sell products it is crucial to get to know the cosmetic legislation.

In this post, you will read everything you need to know, like what kind of ingredients are allowed in cosmetics up to what the product labelling should look like.

What are cosmetics according to EU law?

Cosmetic products are defined by law as follows:

“any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.”

The product must:

  • be a substance or mixture
  • touch the body (the outside, or the mouth cavity)
  • have a cosmetic function

That is why products like shampoos and mascaras are considered cosmetics and products like fake-nails (article), alcohol handgel (non-cosmetic) and scented candles (no body contact) are not cosmetics.

What is the cosmetics regulation?

There is no specific Dutch, French or German law for cosmetics. The European Commission has created the European Cosmetics Regulation EC 1223/2009 and this law is applicable to all EU countries.

Because all products must comply to this international cosmetics regulation, it is much easier to sell cosmetics in multiple EU countries.

The Regulation states that all products must have a safety report. This report must show that all ingredients with their reported use concentrations are safe and that the use of this product is not harmful for human health.

Looking for US cosmetics regulations? We’ve compiled a full list of key differences between the US and EU cosmetics regulations.

What are the requirements for cosmetics?

The most important aspect a cosmetic product needs to comply with is that the product, when used correctly, is safe for human health. That sounds logical and simple, right?

But there are a lot of strings and responsibilities attached to this aspect. For example, each cosmetic product must have a Responsible Person.

That is a person or company present in the EU that takes responsibility for the product and is obligated to guarantee that this product is really safe.

The Responsible Person must ensure that a safety assessment is done, that the product labelling is correct, that customer complaints are handled adequately, etc.

What elements should be present on a cosmetic label?

To ensure that consumer safety is guaranteed, a cosmetic product must have a minimum of 8 (!) labelling elements on its packaging:

  • Responsible Person name and address
  • Nominal content
  • Expiration date
  • Instructions for use including precautions
  • Batch code
  • Product function
  • Ingredient declaration
  • Suitable claims

Which licenses are needed for cosmetics?

Everybody can sell cosmetics, you don’t need a license for this. But it is obligatory for each product to have some sort of license. This is called a Product Information File.

All product characteristics are described in this dossier, including an obligatory safety assessment. This assessment must be cone by safety assessors, specialists who have undergone years and years of specialized training.

This dossier and safety assessment must be finalized before the product is made available on the market. You can compare this with an MOT or a periodic safety check for cars.

You don’t need to send the safety assessment to the government before you are allowed to sell your products; this report is checked by them when the product is on the market.

So there is no waiting time for governmental approval, the product can be sold as soon as the dossier is completed.

Are there any forbidden ingredients for cosmetics?

Yes, not all ingredients are allowed in cosmetic products. This not only includes toxic substances, but also medicinal ingredients and drugs like the painkiller ibuprofen.

These substances cannot be added to cosmetics. Other specific ingredients aren’t forbidden but they are restricted which means that they have special rules.

Only if they exactly follow these rules, restricted ingredients can be used in cosmetics.

All forbidden and regulated ingredients are stated in annexes to the cosmetics regulation:

  • Annex II: forbidden substances
  • Annex III: restricted substances; forbidden unless they follow exact conditions
  • Annex IV: allowed colourants
  • Annex V: allowed preservatives
  • Annex VI: allowed UV filters

Annex IV, V and VI are so-called positive lists, meaning that for these categories only substances can be used if they are on these lists.

Is a colourant not present on Annex IV? Then this is a prohibited colourant. Ingredients on these positives can also be subject to specific extra conditions.

The preservative Phenoxyethanol is allowed because it is present on Annex V. But only if it is used up to 1% in products. More than 1% Phenoxyethanol in a product? Then it is not allowed to be used, despite the ingredient being present on Annex V.

A few times per year a legislative change is done to the cosmetics regulation. Most of these changes have to do with these annex lists.

Ingredients can become prohibited and move to Annex II because new scientific findings show that the ingredient is less safe than we used to think.

That really sucks if this ingredient happens to be in your newly developed product. So it is very important that the Responsible Person really pays attention to these legislative changes.

How do competent authorities check cosmetic safety?

In every EU country, a national competent authority is responsible for checking cosmetic products. In the Netherlands this is the Dutch Food and Goods Authority (NVWA).

To guarantee that cosmetics are safe, companies who product or sell cosmetics must comply to the requirements of the regulation. Do they not comply? Then they risk hefty fees.

The competent authorities do company inspections and they analyze products. During a company inspection, they check if all products have a Product Information File with a good (and positive) safety assessment.

For really bad deviations that may endanger the safety of consumers, the authorities can oblige the Responsible Person to issue a public recall to pull the products from market.

When a national authority like the NVWA require such recall, this recall is also posted in the RAPEX system. You can publicly view these recalls and even see per country which products are unsafe.

The governments have stringent measures to ensure that products comply with legislation. It is therefore important that the Responsible Person ensures that all products have an up-to-date dossier to prevent such events.

Not just to avoid fees and other penalties, but especially to protect consumers.


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