Responsible person, safety assessment, notification: who is in charge of what in cosmetics

Reviewed by Dr. Daniel Wallerstorfer, molecular biologist and founder of Novogenia · Updated: 13 October 2026 · Reading time: 11 min

In short

In the EU, a cosmetic product may only be placed on the market if a responsible person established in the EU has been designated (Art. 4(1) Regulation (EC) No 1223/2009). Before sale, this person ensures a safety assessment with a safety report (Art. 10, Annex I), keeps the product information file (Art. 11), notifies the product via the CPNP (Art. 13) and reports serious undesirable effects (Art. 23). At Novogenia, we take on this role. As a distributor, you remain jointly responsible for your own advertising, for passing the products on and for reports from your customers. Switzerland has no CPNP: there, the manufacturer and the importer carry the self-supervision obligation.

Every cosmetic product needs an address in the EU

Before a serum may be sold in the EU, it must be clear who answers for it. Regulation (EC) No 1223/2009 is unambiguous: only cosmetic products for which a legal or natural person is designated within the EU as the “responsible person” may be placed on the market (Art. 4(1)). For each product, this person ensures compliance with the obligations of the regulation (Art. 4(2)).

Think of the responsible person as the home address of the product. Its name and address appear on the pack (Art. 19(1)(a)). At that address, it keeps the product information file readily accessible to the authorities (Art. 11(3)). And when an authority has questions, that is exactly where it rings the bell.

Who is the responsible person?

Who carries the role depends on how a product reaches the market:

Situation	Responsible person	Legal basis
The product is manufactured in the EU	the manufacturer established in the EU; it may designate, by written mandate, another person in the EU who accepts the mandate in writing	Art. 4(3)
Own brand: you have the product made and sell it under your name or trademark	Legally, you are the “manufacturer” – and therefore the responsible person yourself, unless you designate another person by mandate	Art. 2(1)(d), Art. 4(3)
Import from a country outside the EU	the importer, for the product it places on the market; it may also designate by mandate	Art. 4(5)
A distributor sells under its own name or trademark, or modifies the product in a way that may affect compliance	the distributor	Art. 4(6)

One detail on distributors: merely translating information on a product already on the market does not make a distributor the responsible person (Art. 4(6), subparagraph 2). But a distributor who, on its own initiative, translates elements of the labeling for sale in another Member State must submit certain information to the Commission electronically (Art. 13(3)).

The four big tasks of the responsible person

Article 5(1) lists what the responsible person must ensure: from safety (Art. 3), good manufacturing practice (Art. 8) and the restrictions on substances to labeling (Art. 19(1), (2) and (5)) and product claims (Art. 20). In everyday business, four tasks stand out:

Task	What it involves	Legal basis
Safety assessment	Before placing on the market: safety assessment and safety report in line with Annex I; takes into account the intended use and the systemic exposure to individual ingredients; kept up to date as new information arises	Art. 10(1), Annex I
Product information file	Product description, safety report, method of manufacturing with GMP statement, where justified proof of the effect claimed, data on animal testing; kept for ten years after the last batch was placed on the market	Art. 11
Notification	Before placing on the market, by electronic means to the Commission, via the Cosmetic Products Notification Portal (CPNP): among other things category and name, responsible person, Member State, contact person, nanomaterials, certain CMR substances and the frame formulation; plus the original labeling and, where reasonably legible, a photo of the packaging	Art. 13(1) and (2)
Serious undesirable effects	Notify without delay to the competent authority of the Member State where they occurred – with the product name and any corrective measures taken	Art. 23(1)

On top of that comes the duty to act immediately in case of non-compliance: take corrective measures, withdraw or recall the product and – where it presents a risk to human health – inform the competent authorities without delay (Art. 5(2)).

The safety report: facts in Part A, verdict in Part B

The safety report has two parts. Part A gathers the facts: composition, physical and chemical characteristics and stability, microbiological quality, impurities and packaging material, normal and reasonably foreseeable use, exposure to the product and to the substances, the toxicological profiles of the substances and known undesirable effects. Part B is the verdict: the conclusion on safety, any warnings and instructions for use needed, the scientific reasoning, and the name, qualifications and signature of the assessor (Annex I).

Only a person with a completed university degree in pharmacy, toxicology, medicine or a similar discipline – or a course recognized as equivalent – may carry out the assessment (Art. 10(2)). How the report is structured in detail is described in the Commission guidelines in Implementing Decision 2013/674/EU.

With personalized cosmetics, the selection and dosage of the active ingredients change from person to person. The regulation provides a framework for this: the notification includes a frame formulation (Art. 13(1)(h)). It lists the category or function of the ingredients and their maximum concentration in the product (Art. 2(1)(s)). The safety assessment takes into account the systemic exposure to individual ingredients in a final formulation (Art. 10(1)(a)). It follows that the assessment must cover the formulas that are actually mixed.

Novogenia as the responsible person: what it means for you

At Novogenia, we take on the role of the responsible person. For BeautyMe, we are the manufacturer anyway. For your own brand, you are legally the manufacturer at first, because you have the product made and sell it under your name (Art. 2(1)(d)). By written mandate, you designate us as the responsible person, and we accept the mandate in writing (Art. 4(3)). The safety assessment, product information file and notification then lie with us. The name and address of the responsible person appear on the pack as mandatory information (Art. 19(1)(a)) – your brand, design and presentation remain yours.

That does not take you out of the picture entirely. As a distributor passing the products on to your customers, you have obligations of your own:

Advertising: the ban on misleading claims applies to labeling, making available on the market and advertising (Art. 20(1)) – so also to your website, social media and flyers. The criteria for claims apply irrespective of the medium (Art. 1 Regulation (EU) No 655/2013), and the responsible person must ensure that claims are consistent with the evidence in the product information file (Art. 2). So agree new claims with us beforehand. More in Advertising cosmetics.
Do not modify: anyone who modifies a product in a way that may affect compliance becomes the responsible person themselves (Art. 4(6)).
Due care and checks: distributors act with due care (Art. 6(1)). Before making a product available, they verify that the name and address of the responsible person, the batch number and the ingredient list are present, that the language requirements are met and that the date of minimum durability has not passed (Art. 6(2)).
Storage and transport: while a product is under your responsibility, storage and transport must not jeopardize its compliance (Art. 6(4)).
Risks and serious undesirable effects: where a product presents a risk, distributors immediately inform the responsible person and the competent authorities (Art. 6(3)). Distributors also notify serious undesirable effects themselves (Art. 23(1)).
Supply chain: at the request of the authorities, you identify from whom you obtained the product and to whom you supplied it (Art. 7).

Personalized cosmetics start with a genetic analysis. Under the GDPR, genetic data belong to the specially protected categories of data – how to handle them is explained in Genetic data and the GDPR.

Switzerland: self-supervision instead of CPNP

The EU Cosmetics Regulation does not apply directly in Switzerland. The rules are set out in the Foodstuffs Act (LMG), the Foodstuffs and Consumer Products Ordinance (LGV) and the FDHA Ordinance on Cosmetic Products (VKos). In substance, much is close to the EU – for prohibited and restricted substances, the LGV even refers to the annexes of the EU regulation in the version binding in the EU at the time (Art. 54 LGV). Roles and procedures, however, are organized differently:

Topic	EU	Switzerland
Who carries responsibility?	responsible person established in the EU (Art. 4)	manufacturer and importer (Art. 3(1) VKos); they may designate in writing an authorized representative with an address in Switzerland (Art. 3(2)); the distributor when selling under its own name or trademark (Art. 3(3))
Person in the business	no separate rule	a responsible person with a business address in Switzerland for every business (Art. 73 LGV)
Notification before sale	notification via the CPNP (Art. 13)	no notification, no authorization
Safety report	in line with Annex I (Art. 10)	in line with Annex 5 VKos, structured in parallel (Art. 4 VKos)
Product information file	in a language easily understood by the authority, ten years (Art. 11)	in an official language or English, ten years; a file drawn up abroad is sufficient if it meets the requirements (Art. 5 VKos)
Name on the pack	responsible person (Art. 19(1)(a))	manufacturer, importer, distributor or the responsible person under EU law (Art. 9(1)(b) VKos)
Health hazard	corrective measures, informing the authorities (Art. 5(2)), notification of serious undesirable effects (Art. 23)	inform the cantonal enforcement authority, withdrawal and, where needed, recall (Art. 84 LGV)

For a Swiss partner, this means: anyone who places products from the EU on the market in Switzerland is the importer (Art. 2(1)(d) VKos) and carries the self-supervision obligation (Art. 26 LMG, Art. 74 LGV). The product information file does not have to be drawn up again if the EU file meets the Swiss requirements – but the importer must be able to demonstrate this to the cantonal enforcement authorities (Art. 5(3) VKos). It keeps the self-supervision records available for three years (Art. 13 VKos). So clarify with the manufacturer in advance how you will get the necessary documents quickly if needed.

Checklist: settle the roles before the first bottle is sold

The responsible person is designated; the mandate is given in writing and accepted in writing.
The safety report by a qualified person is in place before the first sale.
The product information file is accessible at the address on the label.
The product is notified in the CPNP before the first sale; the original labeling and a photo of the packaging have been submitted.
Claims are agreed with the responsible person and backed by evidence.
For complaints and serious undesirable effects, it is defined who reports and who informs whom.
Deliveries are documented: obtained from whom, supplied to whom.
For Switzerland: the importer and the responsible person in the business are designated, and access to the product information file is arranged.

How we do it at Novogenia

How we take on responsibility at Novogenia:

Responsible person: We take on the role of the responsible person under the EU Cosmetics Regulation – and with it the safety assessment, the product information file and the notification.
Manufacturing: Day serum, night serum and body lotion are made in our own cosmetics factory in Eugendorf near Salzburg, Austria, certified to ISO 22716 by Quality Austria.
Partner models: Resell BeautyMe, white label on a proven base formulation under your brand, or your own formula – developing it takes 3 to 5 months. We produce from small batches.
No lab of your own: If you resell BeautyMe, you need no lab, no production and no start-up costs.
Training: The NOVO Academy is free of charge and optional and includes a course on the genetics of skin.

Frequently asked questions

Can my studio be the responsible person itself?

Yes, if it is established in the EU. You then carry all obligations under Art. 5(1) Regulation (EC) No 1223/2009 – from the safety assessment by a qualified person and the product information file to notification and the reporting of serious undesirable effects. Alternatively, you designate by written mandate another person in the EU who accepts the mandate in writing (Art. 4(3)).

What goes into the product information file?

A description that clearly identifies the product, the safety report, a description of the method of manufacturing with a statement on good manufacturing practice, where justified proof of the effect claimed, and data on animal testing (Art. 11(2)). The responsible person keeps the file for ten years after the last batch was placed on the market and makes it readily accessible to the authority at the address on the label (Art. 11(1) and (3)).

Who may carry out the safety assessment?

A person holding a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline – or a course recognized as equivalent by a Member State (Art. 10(2) Regulation (EC) No 1223/2009).

What is a serious undesirable effect?

An undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalization, congenital anomalies, an immediate vital risk or death (Art. 2(1)(p)). The responsible person and distributors notify it without delay to the competent authority of the Member State where it occurred (Art. 23(1)).

Do I have to register a cosmetic product in Switzerland?

No. Switzerland has no notification like the EU’s CPNP, and cosmetic products need no authorization. Instead, self-supervision applies (Art. 26 LMG): before the product is first placed on the market, a product information file with a safety report must exist (Art. 57 LGV), and every business designates a responsible person with a business address in Switzerland (Art. 73 LGV).

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Note: This guide is general information for businesses and professionals and does not replace legal advice. BeautyMe products are cosmetic products; statements in this guide are not promises of cure. The genetic traits determined in a genetic analysis are well documented (each gene included is backed by at least three independent studies); recommendations for skincare and formulation derived from them are logical conclusions, not scientifically proven. Regulations can change; errors and changes excepted.