Selling a fragrance in the European Union

Nobody licenses you, and nobody approves the perfume

There is no exam to pass and no permit to hold. You do not send anyone a sample and wait for a yes. What the European Union does instead is put the responsibility on a named person, require that person to hold a complete file before the first bottle is sold, and reserve the right to ask for that file at any time for the next ten years.

That design catches people out in a specific way. Because nothing blocks you, it is entirely possible to sell for two years and only discover what was missing when a market surveillance authority, a marketplace compliance team or an insurer asks. The file is not something to assemble when asked. It is a precondition of the first sale.

First, work out which law you are under

This is the question to settle before any other, because it decides everything that follows, and it is decided by what your customer buys rather than by what you made.

• A perfume sold to a person is a cosmetic. It is applied to the body to perfume it, which is the definition. Regulation (EC) No 1223/2009 governs it: responsible person, product file, safety report, portal notification, ingredient list. A finished cosmetic supplied to a consumer does not need a safety data sheet.
• A concentrate sold to another business is a chemical mixture. Selling perfume oil by the kilo to a candle maker or a soap maker puts you under the chemicals rules instead: classification and labeling under CLP, a safety data sheet under REACH, and poison center notification. This surprises people who think of themselves as perfumers rather than as chemical suppliers, and it is the most commonly missed obligation of the three.
• A candle, a reed diffuser or a room spray is neither. None of them is applied to the body, so none of them is a cosmetic. They sit under general product safety and, where the mixture is classified as hazardous, under CLP. No responsible person and no product file in the cosmetics sense, but a different set of obligations that is easy to overlook because the word cosmetic does not appear anywhere in it.

The rest of this guide is about the first case, which is the one most people are asking about. If you do more than one of the three, and most small houses eventually do, they are separate compliance jobs on the same juice.

The responsible person

Every cosmetic on the EU market must have a responsible person established in the EU or EEA. That person is named and addressed on the label, holds the Product Information File, and answers to the competent authority for it. Selling without one is the single clearest way to be non-compliant.

If you manufacture in the EU, you are the responsible person by default. If you are outside the EU, you must appoint one inside it by written mandate that they accept in writing, and their address goes on your label. Since Brexit a UK entity cannot do this job, so a British maker selling into the EU needs an EU responsible person as well as a UK one.

One thing worth understanding before you shop for the service: a distributor who translates your label or repackages your product can become a responsible person by operation of law, whether or not they intended to. Being clear in writing about who holds the role is worth doing early.

The Product Information File

The PIF is the dossier the responsible person keeps for each product, at the address on the label, for ten years after the last batch was placed on the market. It has to be available in a language the competent authority accepts, and it has to be producible readily. It holds:

• A description of the product that lets the file be unambiguously matched to it.
• The Cosmetic Product Safety Report.
• A description of the method of manufacture, and a statement that it complies with good manufacturing practice.
• Proof of any effect the product claims, where the nature of the claim justifies it.
• Data on any animal testing performed, by anyone in the chain, for this product.

Ten years after the last batch is longer than it sounds. A product discontinued next year, whose final bottle was sold the year after, carries a file obligation into the late 2030s. Records that only exist in a spreadsheet on a laptop do not survive that, and the question always arrives after the laptop has been replaced.

The safety report, and the half you cannot sign yourself

The Cosmetic Product Safety Report comes in two parts and they are very different jobs.

Part A is the safety information. It is assembly rather than judgment: the quantitative and qualitative composition, the physical and chemical properties and stability of both the materials and the finished product, microbiological quality, impurities and packaging information, normal and reasonably foreseeable use, exposure to the product and to each substance, the toxicological profile of each substance, and any undesirable effects already known. Nearly all of it is data you already hold or can get from your suppliers. Gathering it is work, but it is your work.

Part B is the safety assessment. It is the reasoned conclusion that the product is safe, together with any warnings the label must carry. It must be signed by an assessor holding a recognized qualification in pharmacy, medicine, toxicology or an equivalent discipline. If you do not hold that qualification, you cannot sign it, and there is no exemption for a small producer or for a product made in tiny volume.

So budget for an assessor from the beginning. The practical lever you have over that cost is the quality of what you hand them. An assessor given a complete Part A with every composition, density, allergen figure and IFRA position already stated and sourced will quote very differently from one handed a spreadsheet and a box of supplier PDFs. Reformulating after an assessment has been paid for means paying again.

Notifying the portal

Before a product is placed on the market, the responsible person must notify it to the Cosmetic Products Notification Portal. The notification carries the product name and category, the responsible person and where the file is kept, the country of origin for an imported product, the label artwork and container photograph, and either the exact composition or a frame formulation.

The composition question is worth understanding, because it is the part people fear. A frame formulation is a predefined composition range published for a product type, and notifying against one lets you satisfy the portal without publishing your exact formula. The reason the portal wants the information at all is not surveillance: it is so that a poison center can advise a doctor at three in the morning when a child has swallowed something. Exact concentrations become mandatory for substances of particular concern.

It is a notification and not an application. Nobody writes back to approve it. The obligation continues after submission, because a notification has to be updated whenever a change would alter what a poison center would say.

What has to be on the bottle and the carton

Article 19 sets a minimum, and it is longer than most first labels turn out to be:

• The name and address of the responsible person.
• The country of origin, for a product imported into the EU.
• The nominal content at the time of packaging, by weight or volume.
• A date of minimum durability, or the period after opening where durability exceeds thirty months.
• Precautions to be observed in use, including any the safety assessor requires.
• The batch number or an identification of the batch.
• The function of the product, unless it is obvious from presentation.
• The ingredient list, headed Ingredients, in INCI names, in descending order of weight down to 1 percent, with the fragrance as Parfum and the declarable allergens named alongside it.

The batch number is the one that is quietly load-bearing. It is the thread that ties a bottle in a customer's hand back to the lot of every material that went into it, and it is what makes a targeted recall possible instead of a total one. A batch number that cannot be resolved back to material lots is a batch number in name only.

Good manufacturing practice is not optional either

The Regulation requires manufacture in accordance with good manufacturing practice, and following the harmonized standard for cosmetics GMP gives you presumption of conformity. At the scale of a small house this is not a factory audit. It is written procedures, clean and suitable premises and equipment, materials accepted against their documentation, batch records that record what was actually done, traceability in both directions, and complaints and recalls handled in a way that leaves a trail.

In practice the whole of it rests on one habit: recording what really happened at the time it happened, rather than what the formula said should happen. A batch record written from the recipe afterward is not a batch record.

The order to do it in

1. Settle the formula

   The product type and the strength with it, because every later step depends on all three.

2. Check it before you commit

   IFRA at its category, and the allergen declaration, while changing something is still cheap.

3. Gather the documentation

   Compositions, densities and paperwork for every material, from your own suppliers.

4. Appoint the responsible person

   If it is not you. They must be established in the EU or EEA, and their address goes on the label.

5. Assemble Part A, commission Part B

   Part A is yours to gather. Part B needs a qualified assessor's signature and cannot be self-signed.

6. Finalize the label

   After the assessment, not before, because the assessor can require warnings that have to go on it.

7. Notify the portal

   Before the product is placed on the market. It is a notification, so nobody replies to approve it.

8. Then sell, and keep the file

   Ten years after the last batch was placed on the market, at the address on the label.

The two steps people reverse are 6 and 5, printing labels before the assessment, and 2 and 3, commissioning an assessment before knowing the compositions. Both are expensive in the same way: the money is already spent when the problem appears.

How Orris Bench handles this

Orris Bench is built around the file rather than around the formula, because the file is what the Regulation actually asks for. One record runs from the first trial to the batch in a customer's hand, and the documents are generated from it rather than retyped out of it.

It compiles the Product Information File, and produces the portal notification pack, including the frame formulation route where you are notifying against one. It generates the ingredient list in INCI order with the declarable allergens named, the label, and safety data sheets and CLP labels for the cases where you are supplying a mixture to another business rather than a finished cosmetic to a person. Which market a product is for is a fact you state once, and the documents that depend on it read it rather than guessing.

The batch is where it earns its keep. A batch number ties the bottle to the lot of every material that went into it and to the strength that actually came off the balance, and the IFRA verdict and the allergen declaration are stored as they stood on the day of making. Ten years later the record still answers the question that was asked, rather than being quietly rewritten by the current version of the rules.

Sources

Everything above is from Regulation (EC) No 1223/2009 on cosmetic products: the responsible person at Article 4, good manufacturing practice at Article 8, the assessor qualification at Article 10, the Product Information File and its ten-year retention at Article 11, portal notification at Article 13, and labeling at Article 19 with the safety report set out in Annex I. The position that a finished cosmetic supplied to a consumer needs no safety data sheet follows from REACH Article 2(6)(b). This page is written for people who make fragrances and it is not legal advice; the Official Journal texts are the authority, they are free to read, and a qualified safety assessor is the person to ask about your specific product.