EU Cosmetic Regulation 1223/2009 applies to finished cosmetic products and sets out several requirements for brands wishing to place a product on the European market.
One of the key steps in this compliance process concerns the labelling of cosmetic products.
A compliant label is not limited to a few mandatory statements: it must be consistent with the formula, the Product Information File, the safety report, the CPNP notification and the claims used to promote the product.
Follow our guide to better understand cosmetic labelling requirements in Europe and secure the market access of your products.
The EU Cosmetic Regulation
Applicable since 2013, EU Cosmetic Regulation No. 1223/2009 governs the placing of cosmetic products on the market in the 27 Member States of the European Union. It is also relevant for countries in the European Economic Area, including Iceland, Liechtenstein and Norway.
The United Kingdom now has its own cosmetic regulatory framework. Although some requirements remain close to the EU framework, UK obligations must be checked separately, particularly regarding the UK Responsible Person, the SCPN notification and certain labelling information.
To successfully place a cosmetic product on the EU market, labelling must be carefully checked, together with the formula, product safety and related regulatory documentation.
Definitions
Cosmetic product: “Means 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".
Labeling: Mandatory requirements
Article 19 of the EU cosmetic regulation defines the rules for a compliant cosmetic label.
Mandatory information must appear on the product in indelible, easily legible and visible lettering.
1. Name and address of the Responsible Person
The name or registered name and address of the Responsible Person must appear on the label.
If your company is located outside the European Union, it is mandatory to appoint a Responsible Person established in the EU before placing the product on the EU market.
Where several addresses are indicated, the address at which the Product Information File is made readily accessible must be highlighted.
2. Country of origin
The country of origin must be indicated for cosmetic products imported into the European Union.
Examples:
- Made in Canada
- Made in Korea
- Made in USA
This information is not required for a product manufactured within the European Union.
3. Nominal content
The nominal content must appear in grams (g) or millilitres (ml).
Examples:
- 50 ml
- 100 g
- 250 ml
Certain exceptions exist, particularly for free samples, single-use packs or some very small products.
4. Date of Minimum Durability and Period After Opening
If the product’s minimum durability is less than or equal to 30 months, the Date of Minimum Durability must be indicated, together with the hourglass symbol or the appropriate wording.
If the minimum durability is more than 30 months, the Date of Minimum Durability is generally not required. In that case, the Period After Opening, or PAO, must be indicated using the open jar symbol followed by the number of months or years.
Examples:
- 6M
- 12M
- 24M
The PAO must be consistent with the available data on product stability, microbiological safety, packaging type and normal conditions of use.
5. Particular precautions for use and warnings
Depending on the type of cosmetic product, certain precautions for use and warnings may be mandatory.
This may concern, for example:
- certain hair products;
- certain sunscreen products;
- substances regulated in the annexes to the Regulation;
- ingredients requiring specific warnings.
For example, certain products containing formaldehyde-releasing substances may require the warning “releases formaldehyde” when the applicable regulatory threshold is exceeded.
6. Batch number
The batch number, or any reference allowing the cosmetic product to be identified, is mandatory.
This information is essential for traceability. It allows the products concerned to be identified in the event of a complaint, non-compliance, recall or withdrawal from the market.
7. Product function
The function of the product must be clearly indicated, unless it is already obvious from the product presentation.
Examples:
- face moisturiser
- shampoo
- cleansing milk
8. List of ingredients
The list of ingredients must be preceded by the term “Ingredients”.
Ingredients must be listed:
- using their INCI name;
- in descending order of weight at the time they are added to the product;
- with some flexibility for ingredients present at less than 1%, which may be listed in any order after those present above 1%.
Perfume and aromatic compositions may be indicated using the terms “Parfum” or “Aroma”.
Colourants may be listed using their CI number.
Ingredients present in the form of nanomaterials must be indicated with the word [nano] after their name.
Important notes
Translation
The EU Cosmetic Regulation applies across multiple language markets, and certain mandatory information intended for the end user must be available in the language or languages required by each country of sale.
In practice, this may concern:
- the function of the product;
- precautions for use;
- warnings;
- certain information necessary for the safe use of the product.
Small packaging
Where, for practical reasons, all mandatory information cannot appear directly on the packaging, certain information may be provided on a leaflet, an attached label, a tag, a tape or a card enclosed with the product.
Mandatory symbols
The hourglass symbol is used to indicate the Date of Minimum Durability when this is less than or equal to 30 months. The date must appear next to the symbol or be clearly associated with it.
If the minimum durability exceeds 30 months, the open jar symbol indicates the Period After Opening.
Example: 12M means that the product can be used for 12 months after opening under normal conditions of use.
The book and hand symbol informs consumers that a leaflet, label, tag or card accompanies the product and contains additional regulatory information.
Diagram: example of a compliant label
Fragrance allergens: a key point of attention
An important point to include in the updated article concerns fragrance allergens.
The EU framework has evolved and now requires increased vigilance regarding the declaration of certain fragrance allergens on cosmetic labels.
The declaration thresholds remain:
- 0.001% for leave-on products
- 0.01% for rinse-off products
This verification is particularly important for products containing:
- fragrances;
- essential oils;
- botanical extracts;
- aromatic compositions.
Claims
Cosmetic product claims are governed by Article 20 of Regulation 1223/2009, as well as Regulation (EU) No. 655/2013 on common criteria for cosmetic claims.
Cosmetic claims are used to present a product on:
- the label;
- the packaging;
- the website;
- marketing materials;
- social media;
- advertisements.
They must:
- describe the effects of the product;
- help consumers understand the product;
- remain fair and substantiated;
- not mislead the consumer.
6 common criteria
- Legal compliance
- Truthfulness
- Evidential support
- Honesty
- Fairness
- Informed decision-making
Claims such as “hypoallergenic”, “natural”, “clean beauty”, “free from”, “clinically proven” or “dermatologically tested” must be used with caution and must be supported by appropriate evidence.
Would you like to learn more about cosmetic labelling compliance in Europe?
Cosmetic label compliance cannot be assessed in isolation. It must be consistent with:
- the formula;
- supplier documentation;
- the safety report;
- the Product Information File;
- the CPNP notification;
- the claims used.
EcoMundo supports cosmetic brands in the regulatory verification of their products before they are placed on the European market.
For more information on cosmetic compliance, do not hesitate to contact our experts
EU Cosmetic Regulation 1223/2009 applies to finished cosmetic products and sets out several requirements for brands wishing to place a product on the European market.
One of the key steps in this compliance process concerns the labelling of cosmetic products.
A compliant label is not limited to a few mandatory statements: it must be consistent with the formula, the Product Information File, the safety report, the CPNP notification and the claims used to promote the product.
Follow our guide to better understand cosmetic labelling requirements in Europe and secure the market access of your products.
The EU Cosmetic Regulation
Applicable since 2013, EU Cosmetic Regulation No. 1223/2009 governs the placing of cosmetic products on the market in the 27 Member States of the European Union. It is also relevant for countries in the European Economic Area, including Iceland, Liechtenstein and Norway.
The United Kingdom now has its own cosmetic regulatory framework. Although some requirements remain close to the EU framework, UK obligations must be checked separately, particularly regarding the UK Responsible Person, the SCPN notification and certain labelling information.
To successfully place a cosmetic product on the EU market, labelling must be carefully checked, together with the formula, product safety and related regulatory documentation.
Definitions
Cosmetic product: “Means 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".
Labeling: Mandatory requirements
Article 19 of the EU cosmetic regulation defines the rules for a compliant cosmetic label.
Mandatory information must appear on the product in indelible, easily legible and visible lettering.
1. Name and address of the Responsible Person
The name or registered name and address of the Responsible Person must appear on the label.
If your company is located outside the European Union, it is mandatory to appoint a Responsible Person established in the EU before placing the product on the EU market.
Where several addresses are indicated, the address at which the Product Information File is made readily accessible must be highlighted.
2. Country of origin
The country of origin must be indicated for cosmetic products imported into the European Union.
Examples:
- Made in Canada
- Made in Korea
- Made in USA
This information is not required for a product manufactured within the European Union.
3. Nominal content
The nominal content must appear in grams (g) or millilitres (ml).
Examples:
- 50 ml
- 100 g
- 250 ml
Certain exceptions exist, particularly for free samples, single-use packs or some very small products.
4. Date of Minimum Durability and Period After Opening
If the product’s minimum durability is less than or equal to 30 months, the Date of Minimum Durability must be indicated, together with the hourglass symbol or the appropriate wording.
If the minimum durability is more than 30 months, the Date of Minimum Durability is generally not required. In that case, the Period After Opening, or PAO, must be indicated using the open jar symbol followed by the number of months or years.
Examples:
- 6M
- 12M
- 24M
The PAO must be consistent with the available data on product stability, microbiological safety, packaging type and normal conditions of use.
5. Particular precautions for use and warnings
Depending on the type of cosmetic product, certain precautions for use and warnings may be mandatory.
This may concern, for example:
- certain hair products;
- certain sunscreen products;
- substances regulated in the annexes to the Regulation;
- ingredients requiring specific warnings.
For example, certain products containing formaldehyde-releasing substances may require the warning “releases formaldehyde” when the applicable regulatory threshold is exceeded.
6. Batch number
The batch number, or any reference allowing the cosmetic product to be identified, is mandatory.
This information is essential for traceability. It allows the products concerned to be identified in the event of a complaint, non-compliance, recall or withdrawal from the market.
7. Product function
The function of the product must be clearly indicated, unless it is already obvious from the product presentation.
Examples:
- face moisturiser
- shampoo
- cleansing milk
8. List of ingredients
The list of ingredients must be preceded by the term “Ingredients”.
Ingredients must be listed:
- using their INCI name;
- in descending order of weight at the time they are added to the product;
- with some flexibility for ingredients present at less than 1%, which may be listed in any order after those present above 1%.
Perfume and aromatic compositions may be indicated using the terms “Parfum” or “Aroma”.
Colourants may be listed using their CI number.
Ingredients present in the form of nanomaterials must be indicated with the word [nano] after their name.
Important notes
Translation
The EU Cosmetic Regulation applies across multiple language markets, and certain mandatory information intended for the end user must be available in the language or languages required by each country of sale.
In practice, this may concern:
- the function of the product;
- precautions for use;
- warnings;
- certain information necessary for the safe use of the product.
Small packaging
Where, for practical reasons, all mandatory information cannot appear directly on the packaging, certain information may be provided on a leaflet, an attached label, a tag, a tape or a card enclosed with the product.
Mandatory symbols
The hourglass symbol is used to indicate the Date of Minimum Durability when this is less than or equal to 30 months. The date must appear next to the symbol or be clearly associated with it.
If the minimum durability exceeds 30 months, the open jar symbol indicates the Period After Opening.
Example: 12M means that the product can be used for 12 months after opening under normal conditions of use.
The book and hand symbol informs consumers that a leaflet, label, tag or card accompanies the product and contains additional regulatory information.
Diagram: example of a compliant label
Fragrance allergens: a key point of attention
An important point to include in the updated article concerns fragrance allergens.
The EU framework has evolved and now requires increased vigilance regarding the declaration of certain fragrance allergens on cosmetic labels.
The declaration thresholds remain:
- 0.001% for leave-on products
- 0.01% for rinse-off products
This verification is particularly important for products containing:
- fragrances;
- essential oils;
- botanical extracts;
- aromatic compositions.
Claims
Cosmetic product claims are governed by Article 20 of Regulation 1223/2009, as well as Regulation (EU) No. 655/2013 on common criteria for cosmetic claims.
Cosmetic claims are used to present a product on:
- the label;
- the packaging;
- the website;
- marketing materials;
- social media;
- advertisements.
They must:
- describe the effects of the product;
- help consumers understand the product;
- remain fair and substantiated;
- not mislead the consumer.
6 common criteria
- Legal compliance
- Truthfulness
- Evidential support
- Honesty
- Fairness
- Informed decision-making
Claims such as “hypoallergenic”, “natural”, “clean beauty”, “free from”, “clinically proven” or “dermatologically tested” must be used with caution and must be supported by appropriate evidence.
Would you like to learn more about cosmetic labelling compliance in Europe?
Cosmetic label compliance cannot be assessed in isolation. It must be consistent with:
- the formula;
- supplier documentation;
- the safety report;
- the Product Information File;
- the CPNP notification;
- the claims used.
EcoMundo supports cosmetic brands in the regulatory verification of their products before they are placed on the European market.
For more information on cosmetic compliance, do not hesitate to contact our experts
