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Every new cosmetic formula involves several people: the brand that wants the product, the chemist who balances the ingredients, the plant that runs the first batch, the professional who signs the safety assessment. Regulation (EC) No 1223/2009 does not ask who wrote the formula. It asks a different question, about the finished product: who answers for it in the Union? For a brand outside the EU, or an importer launching its first product, the answer is less obvious than it looks, and it is cheaper to settle before the formula is fixed than after the first batch.
Who is who around a new cosmetic formula
The Regulation defines roles by what a party does with the product, not by who designed it. The manufacturer under Article 2 is whoever makes a product, or has it designed or made, and markets it under its own name or trademark. A brand that commissions a laboratory to develop the formula and a plant to produce it is therefore the manufacturer for legal purposes, while for a contract plant that only produces for the brand the definition is not something to assume: settle in the contract, in writing, who acts as the manufacturer and who as the responsible person.
The importer is a person established in the Union who places a product from a third country on the market; the distributor is any other party in the supply chain that makes the product available. Around them sit the Responsible Person and the safety assessor, two further roles that are often confused with the others.
Whose name goes on the label when the brand is outside the EU
Article 4(1) allows a cosmetic product on the market only if a natural or legal person has been designated as its Responsible Person in the Union. The rest of the article tells you who that is. If the product is made in the EU and not exported and re-imported, the manufacturer established in the EU is the Responsible Person, and it may designate someone else by written mandate that the other accepts in writing. If that manufacturer is established outside the EU, Article 4(4) obliges it to designate, by written mandate, a person established in the EU who accepts in writing. For imported products, Article 4(5) makes each importer the Responsible Person for the specific product it places on the market, with the same option of a written mandate. A distributor becomes the Responsible Person if it places a product on the market under its own name or trademark, or modifies one in a way that could affect compliance; translating the product information is expressly not such a modification.
Take a concrete case. A brand based outside the EU commissions the formula and the production from an EU laboratory. The brand is the manufacturer under Article 2 and it is established outside the Union, so Article 4(4) applies: it needs a written mandate to a person in the EU, accepted in writing. The laboratory does not become the Responsible Person by default. Change one fact, production in Asia and import by a Spanish company, and the importer is the Responsible Person by default. Our guide to the Responsible Person covers the role in full.
The safety obligation and the person who assesses it
Article 3 sets the standard: a cosmetic must be safe for human health under normal or reasonably foreseeable conditions of use, taking into account its presentation, labelling, instructions and any other information the Responsible Person provides. Warnings on the label do not relieve anyone of the other obligations in the Regulation.
Article 10 turns that standard into work. Before the product is placed on the market, the Responsible Person must ensure that a safety assessment has been carried out and that a safety report has been drawn up in line with Annex I. The assessment has to take into account the intended use and the anticipated systemic exposure to the individual ingredients of the final formulation, which is why it cannot be closed on a draft. Article 10(2) requires the assessment to be carried out by a person holding a university-level qualification in pharmacy, toxicology, medicine or a similar discipline, or a qualification a Member State recognises as equivalent.
Annex I sets the content. Part A covers composition, stability, microbiological quality, impurities, exposure, the toxicological profile of the substances with the margin of safety, and undesirable effects. Part B holds the conclusion, the warnings the label needs, the reasoning, and the assessor’s name, address, proof of qualification, date and signature. The assessor signs Part B; Article 10(1) puts the duty to make sure the assessment exists, and is updated with information generated after launch, on the Responsible Person. The Cosmetic Product Safety Report is that document.
The file and the notification that carry the formula
Under Article 11 the Responsible Person holds a Product Information File for ten years after the last batch was placed on the market. It contains a description of the product, the safety report, a description of the method of manufacture with a declaration of compliance with good manufacturing practice, proof of the claimed effect where justified, and data on animal testing. It must be available to the competent authority of the Member State where it is kept, at the address on the label, in a language the authority can readily understand.
Before launch, Article 13 requires the Responsible Person to notify the Commission electronically. The notification carries the category and name, the Responsible Person’s name and address, the country of origin for imports, any nanomaterials, the CMR substances of categories 1A and 1B, and the framework formulation that allows rapid medical treatment if something goes wrong. Changes must be updated immediately. Article 19(1)(a) puts the Responsible Person’s name and address on the packaging, plus the country of origin for imports. Our CPNP notification guide walks through the Commission’s portal.
The plant, good manufacturing practice and what the contract covers
Article 8 requires manufacture under good manufacturing practice and presumes conformity when it follows the relevant harmonised standards published in the Official Journal. The Commission lists EN ISO 22716:2007, the good manufacturing practice guidelines for cosmetics, among the harmonised standards for the Regulation, and two points from its text matter to a brand commissioning a new cosmetic formula. Its scope is production, control, storage and shipment; research and development, and distribution of the finished product, are outside it, so a plant’s GMP evidence tells you how the product is made, not whether the formula is safe. And clause 12 on subcontracting expects a written contract that specifies the respective duties of contractor and subcontractor. That contract is worth having, but Article 5(1) lists Article 8 among the provisions the Responsible Person must guarantee.
What a contract cannot move
You can move three things by contract: the manufacture, the assessment and the Responsible Person role itself, the last only by the written mandate Article 4 describes, accepted in writing by a person established in the Union. What you cannot do is leave the product without a Responsible Person, or push the duties of Article 5 onto the formulator, the plant or the assessor while the Responsible Person stays a name on the label.
Article 5 is specific. The Responsible Person guarantees compliance with Articles 3, 8 and 10 to 18, parts of Article 19, and Articles 20, 21, 23 and 24. If it has reason to think a product on the market does not comply, it must take corrective measures at once and, where there is a risk to human health, inform the national authorities immediately. On a reasoned request it must hand over the documentation showing conformity, in a language the authority understands, and Article 23 adds immediate notification of serious undesirable effects.
A supply agreement with your formulator or plant, including indemnities, allocates cost and recourse between the parties. It does not change the party the Regulation names to the authority. Nor does a warning on the label, as Article 3 says, and nor does the assessor’s signature. After almost twenty years assessing the safety and conformity of cosmetics and food supplements, we see three problems repeatedly: a brand that believes the contract plant is its Responsible Person because the plant issues the invoices; a formula adjusted at the plant after the assessment was signed; and a label that shows an address where nobody keeps the file.
A sensible order of decisions
Decide first who will be the Responsible Person and put the mandate in writing. Then choose the manufacturer, ask for its GMP evidence and agree the subcontracting terms. Fix the formula and give the assessor the final version. Only then build the file, notify and finalise the label; every later change of composition goes back to the assessor.
If you still need the formula itself, our cosmetic formulation service delivers the formula only: the ingredient list with percentages, checked against the annexes of the Regulation. Labelling, claims and the safety report are separate services.
Frequently asked questions
Can my contract manufacturer be my Responsible Person?
Yes, if it is established in the Union and accepts the role in writing under the mandate Article 4 describes. Accepting the role means accepting the Article 5 duties.
Next step
If you are about to launch a new cosmetic formula in the EU and are not sure who in your chain holds which role, write to us through our contact page before the first production order, and a technician at ASC will go through it with you.