Labels & market rules

Selling Perfume in the EU: Responsible Person, Safety Report and CPNP

The EU rules for perfume under Regulation 1223/2009: responsible person, safety report, product information file, CPNP notification, GMP and label.

Short answer

To sell perfume in the European Union, a product needs a responsible person established in the EU, a safety assessment by a qualified assessor documented in a cosmetic product safety report, a product information file kept for ten years after the last batch is placed on the market, a notification in the EU's Cosmetic Products Notification Portal (CPNP) before it goes on sale, manufacture under good manufacturing practice, and a label that meets Article 19 of Regulation (EC) No 1223/2009 — including fragrance allergens above the thresholds. The rules are the same in every member state, but labels must be in the languages each country requires.

Cosmetics in the EU — perfumes included — are governed by Regulation (EC) No 1223/2009, the Cosmetics Regulation. It applies directly in every member state and covers safety, ingredients, labeling, notification and post-market duties. Its annexes list prohibited substances (Annex II), restricted substances (Annex III, which includes the fragrance allergens), permitted colorants (Annex IV), preservatives (Annex V) and UV filters (Annex VI). The European Commission's cosmetics pages explain how it is applied.

The IFRA Standards are a separate, industry framework; a product can meet one and not the other. See IFRA Standards explained.

The responsible person

Every cosmetic product placed on the EU market must have a designated responsible person — a natural or legal person established in the EU — who ensures it complies (Article 4). For an EU-based brand, that is usually the brand itself. For a brand outside the EU, it is typically the importer or a contracted responsible-person service. The responsible person's name and address appear on the label, and the product information file is kept at that address.

Safety assessment and the product information file

Before a product is placed on the market, the responsible person must ensure it has been assessed for safety by a suitably qualified person, documented in a cosmetic product safety report (Article 10 and Annex I). The report has two parts: safety information (composition, physical and chemical properties and stability, microbiological quality, impurities, packaging, intended use, exposure, toxicological profiles of the ingredients, undesirable effects) and the assessor's conclusion.

The safety report sits inside the product information file (Article 11), which also contains a description of the product, the manufacturing method and a statement of good manufacturing practice, proof of any claimed effects, and data on any animal testing. It must be kept readily accessible at the responsible person's address for ten years after the last batch was placed on the market. What an assessor needs from you to write the report is covered in what a safety assessor needs from you.

Notification in the CPNP

Before placing a product on the market, the responsible person notifies it through the Cosmetic Products Notification Portal (Article 13), a free online system run by the European Commission. The notification includes the product's category and name, the responsible person, the country of origin for imports, the presence of substances in nanomaterial form, certain substances of concern, and the frame formulation or exact formulation needed for poison centers.

Good manufacturing practice

Products must be manufactured according to good manufacturing practice (Article 8). Compliance is presumed when production follows the relevant harmonized standard, which is EN ISO 22716; see cosmetic GMP and ISO 22716.

The label

Article 19 lists what must appear on the container and packaging. For a perfume, in summary:

  • the name or registered name and address of the responsible person;
  • the country of origin, for imported products;
  • the nominal content at the time of packaging, by weight or volume;
  • the date of minimum durability, or a period-after-opening symbol, where required — see perfume expiry dates and PAO;
  • particular precautions for use, where needed;
  • the batch number or a reference identifying the product — see perfume batch numbers and lot codes;
  • the function of the product, unless clear from its presentation;
  • the list of ingredients (which may appear on the outer packaging only), using common ingredient names, with "parfum" for the fragrance and fragrance allergens named above the thresholds.

Writing the ingredient list is covered in perfume ingredient labeling, the allergen rules in EU fragrance allergen labelling, and the list of allergens in the fragrance allergens list.

After launch

  • Serious undesirable effects must be notified to the competent authority of the member state where they occurred (Article 23).
  • Claims must meet the EU's common criteria for cosmetic claims; see perfume claims.
  • Changes to the formula mean updating the safety report, the product file and, where relevant, the notification.
  • Annex amendments — new restrictions or allergens — must be tracked and acted on by their dates.

A practical sequence for a small brand

  1. Decide who will be the responsible person.
  2. Finalize the formula; check it against the annexes and IFRA Standards; complete stability testing.
  3. Assemble the documents and commission the safety assessment.
  4. Prepare the product information file and the label (in the required languages).
  5. Notify in the CPNP.
  6. Place on the market, and keep records of batches and complaints.

Selling in Great Britain needs a separate GB responsible person and notification; see selling perfume in the UK. Other markets are compared in perfume regulations by market.

Sources

Frequently asked questions

Do small or handmade brands get an exemption?

No. The Regulation applies to every cosmetic product placed on the EU market, whatever the size of the business or batch.

Can I sell to EU customers online from outside the EU?

Products sold to consumers in the EU must comply, which includes having an EU responsible person. Arrange this before selling.

Written and reviewed by the RUŌOD Lab team. This article is general education about perfume formulation and record-keeping; it is not legal, regulatory or safety advice, and the examples are illustrations, not validated commercial formulas. How we write and check these guides.

Formulate with the arithmetic done for you

RUŌOD Lab exports formulas and materials as PDF, CSV, Excel and JSON for your safety assessor and records.