Cosmetic labelling requirements: every mandatory particular, one by one

Cosmetic labelling requirements are set by Article 19 of Regulation (EC) No 1223/2009: Responsible Person, country of origin, nominal content, date of minimum durability or PAO, precautions for use, batch number, function and INCI list. According to COSMED, these particulars must be printed in indelible, easily legible and visible characters. Manufacturing in Tunisia does not exempt you from these requirements when selling in Europe.

This informational article separates what the regulation sets from what falls to the laboratory and the brand. It details each particular, the symbols and the points distributors watch, then offers a pre-print checklist. For the general framework, the Regulation and quality category of the blog gathers the articles on the subject.

What are the mandatory particulars on a cosmetic label?

Article 19 of Regulation (EC) No 1223/2009 sets the particulars of a cosmetic label: Responsible Person and address, country of origin, nominal content, date of minimum durability or PAO, precautions for use, batch number, product function and list of ingredients. They must be indelible, legible and visible. This article is informational: refer to EUR-Lex.

Labelling is all the written or symbolic information carried on a product’s container and packaging. According to FEBEA, this obligation applies to all cosmetic products, whether sold in shops, on the internet or by mail order.

Here are the eight particulars to include:

1. the name and address of the Responsible Person;
2. the country of origin;
3. the nominal content;
4. the date of minimum durability or the period after opening (PAO);
5. precautions for use and warnings;
6. the batch number;
7. the product function;
8. the list of ingredients, known as the INCI list.

“The following mandatory information must be printed on the product ‘in indelible, easily legible and visible characters’” (COSMED)

This information appears on both the container label and the packaging label. FEBEA specifies, however, that the list of ingredients may appear on the packaging only.

Before designing the label, our advice is to fix five elements: the target, the benefit sought, the selling price, the quantity and the overall budget. A brief that changes along the way means redoing the artwork. For the reference text, see the consolidated text of the regulation on EUR-Lex.

Who is the Responsible Person and which country of origin should you state for a product made in Tunisia?

To sell in the European Union, a Responsible Person established in the EU guarantees the product’s compliance and appears on the label with their address. According to COSMED, the country of origin is among the mandatory particulars: for a product made in Tunisia, it is Tunisia. Manufacturing outside the EU does not exempt you from the requirements of the destination market.

Responsible Person established in the EU

The Responsible Person is the natural or legal person who guarantees that the cosmetic product complies with the regulation. According to EUR-Lex, the Responsible Person ensures, for each cosmetic product placed on the market, compliance with the applicable obligations set out in the regulation.

For an imported product, each importer is the Responsible Person for the product they place on the market. A distributor becomes one when they market a product under their own name or brand.

Our advice: manufacturing in Tunisia does not exempt you from the requirements of the destination market. For the European Union, you notably need a Responsible Person established in the EU, a PIF (Product Information File) with a safety assessment (CPSR), a compliant composition and labelling, and a CPNP notification on the portal before marketing. This notification is neither an authorisation nor a quality certification.

Country of origin and address

The country of origin is among the particulars that COSMED lists right after the name and address of the Responsible Person. For a product made in Tunisia, you therefore state Tunisia, and the Responsible Person’s address remains that of an operator established in the EU if you are targeting that market.

We recommend defining your countries of sale from the brief onwards: the laboratory can then prepare the corresponding supporting documents and packaging. If you are building your brand from scratch, ask your laboratory to build this thinking in from the start, for example as part of brand creation support. Reminder: this content is informational; only the official texts are authoritative.

Date of minimum durability, PAO, nominal content, batch: how do you read and choose the symbols?

The date of minimum durability is mandatory when the product’s durability is under 30 months. Beyond that, the PAO, symbolised by an open jar followed by a number of months and the letter M, replaces it. The nominal content is expressed by weight or volume, and the batch number ensures traceability.

The date of minimum durability is the date before which the product is best used. The period after opening (PAO) is the length of time the product remains safe once opened.

Table of particulars and symbols

According to FEBEA, the purpose of the batch number is to guarantee the identification and traceability of a product throughout the supply chain, particularly in the event of a recall. At Oppenheimer Lab, the full history of a batch is available within 24 hours.

Date of minimum durability or PAO: which should you choose?

The choice is not a matter of taste: it follows from the product’s durability. According to FEBEA, the date of minimum durability is mandatory if durability is under 30 months. Beyond that threshold, the PAO takes over.

Some products display neither a date of minimum durability nor a PAO, such as single-dose products or perfumes, according to COSMED.

The period chosen is based on testing. According to Implementing Decision 2013/674/EU, stability assessment is used to determine the minimum durability and the period of use after opening. So ask your laboratory for the stability results before fixing the artwork.

How do you draw up the INCI list, the function and the precautions for use?

The INCI list names the ingredients in descending order of weight, with those present at less than 1% allowed to follow in any order. It may appear on the packaging alone. The product function must be clearly stated, and the precautions for use derive from the cosmetic product safety report.

List of ingredients

The INCI list is the list of ingredients written according to the international nomenclature of cosmetic ingredients. According to COSMED, it gives the names of the ingredients in descending order of weight, except those present at less than 1%.

For online sales, FEBEA indicates that the list also appears in the product’s web description. So plan this text from the product page stage.

Function and precautions

The product function is the use announced to the consumer, for example moisturising or cleansing. According to FEBEA, it must be clearly stated on the container and on the packaging.

Have the precautions for use validated by your laboratory and the person in charge of the safety assessment. Have them validate each warning before printing.

On a small bottle, FEBEA mentions the open book symbol, which then refers to the packaging.

Our advice: never order your bottles before confirming their compatibility with the formula. Also check that they leave the space needed for the particulars. We recommend testing the formula-container pairing before launching the whole order; our filling and packaging page details this step.

What mistakes and points of vigilance matter for distributors and brands?

Before making a product available, the distributor checks certain particulars of Article 19 of Regulation (EC) No 1223/2009, compliance with language requirements and the date of minimum durability. A non-compliant product can only be distributed once brought into compliance. Claims fall under Article 20 and Commission Regulation (EU) No 655/2013.

Distributor checks

A distributor is the supply chain operator, other than the manufacturer or the importer, who makes a product available on the market. According to EUR-Lex, they check that the labelling carries the information required by Article 19, that the language requirements are met and that the date of minimum durability has not passed.

If the distributor considers that a product is not compliant, they may only make it available once it has been brought into compliance. For a brand, the stakes are concrete: an incomplete label can block a listing in parapharmacy. Have your artwork reviewed before printing, not after.

Claims and language

A claim is a statement that attributes a quality or an effect to the product. It falls under Article 20 of Regulation (EC) No 1223/2009 and Commission Regulation (EU) No 655/2013. The label language depends on Article 19, paragraph 5: check this text for each country of sale.

Beware of common phrases. For “vegan”, COSMED indicates that there is no common standard or label: each label or marketer imposes its own criteria. According to COSMED, the statement “not tested on animals” is prohibited in the European Union; for any other statement of the “paraben-free” type, ask your laboratory whether it is justified under these texts.

Also be careful with sensitive terms such as SPF or organic: ask your laboratory what supporting evidence backs them before printing them.

Pre-print checklist: what should you check and where should you start?

Before printing, check each mandatory particular, the space available on the container, the batch number, the dates and consistency with the product file. Have the artwork reviewed by your laboratory and by the Responsible Person, then request a quote. This check avoids reprinting an entire run.

A checklist is a list of points to validate one by one, in the same order, before any label order. Here is a basis to tick off:

• the name and address of the Responsible Person, and the country of origin, are present and accurate;
• the nominal content is given by weight or volume;
• the date of minimum durability or PAO matches the stability results provided by the laboratory;
• the batch number is planned for printing or marking;
• the precautions for use have been validated by the person in charge of the safety assessment;
• the product function is clear on the container and on the packaging;
• the INCI list is complete and reproduced in the online product page;
• claims and language have been checked country by country.

Take a typical example: a Tunisian entrepreneur launches her first skincare brand sold online. She chooses a single reference, a 50 ml face moisturiser, based on an existing formula already validated. For 1,000 units, a timeline of about twelve weeks is realistic, provided the packaging is available, validations are quick and checks are satisfactory. The label artwork is part of these validations.

Our advice: start with one or two products that are well positioned, keep budget aside to market them, then expand the range based on customer feedback. Each reference adds a label to check.

At Oppenheimer Lab, manufacturing follows cosmetic Good Manufacturing Practice (GMP, ISO 22716), and we prepare PIFs (Product Information Files) and CPNP notifications. To launch your project, you can request a quote: we reply within 48 working hours. This article remains informational; only the official texts, available on EUR-Lex, are authoritative.

Sources

• Consolidated text: Regulation (EC) No 1223/2009, version of 01.05.2025, EUR-Lex (European Union), 1 May 2025
• Implementing Decision 2013/674/EU: guidelines on Annex I to Regulation (EC) No 1223/2009, EUR-Lex (European Union), November 2013
• Tout savoir sur l’étiquetage de vos produits cosmétiques en Europe (in French), FEBEA (Fédération des entreprises de la beauté), undated
• Decode your cosmetic products (in French), COSMED (association professionnelle), April 2021