How to place a cosmetic product on the market in the EU and Hungary: a plain-language guide for 2026

A cosmetic product can be placed lawfully on the market in the European Union and Hungary once five things are in order: it has a responsible person, its safety assessment is complete, its product information file (PIF) has been compiled, it has been notified on the EU cosmetics portal (CPNP), and its label meets the requirements. No authorisation is needed, but the authorities may check at any time that all of these are in place.

If you are about to launch a cream, a soap or an own-brand product range, you are probably asking the same three questions as most of our clients. What exactly is required? Who is responsible? And what happens when an inspection comes? In this guide we explain, in everyday language rather than legal jargon, what the law requires and why. The exact legal references are given in brackets for anyone who wants to look them up.

In one sentence: in the EU a cosmetic product can be placed on the market without authorisation but subject to five conditions (a responsible person, a safety assessment, a product information file (PIF), a CPNP notification and a compliant label), while Hungary adds Hungarian-language labelling and notification of domestic manufacturing 30 days in advance; InnovaTox helps with all of this, drawing on 25 years of regulatory and expert experience.

What do you need to sell a cosmetic product, in short?

Selling a cosmetic product requires five mandatory elements, and all five must be in place before the first unit reaches a shelf or a webshop. You can use this table as a checklist.

All of this is based on Regulation (EC) No 1223/2009 of the European Parliament and of the Council (30 November 2009) on cosmetic products, which applies directly in every EU Member State. In Hungary it is supplemented by Government Decree 246/2013 (VII. 2.) on cosmetic products.

Does a cosmetic product need to be authorised?

No: in the EU there is no authorisation procedure for cosmetic products, only a notification obligation. What people often call "cosmetic product approval" actually means the five steps above: the responsible person demonstrates compliance under their own responsibility, then notifies the product on the CPNP. The authorities check afterwards, on the market, so the documentation must be ready from the very first unit sold.

What counts as a cosmetic product?

A cosmetic product is any product intended for the skin, hair, nails, lips, teeth or oral cavity in order to clean, perfume, beautify, protect or care for them (Regulation (EC) No 1223/2009, Article 2). This includes shampoo, toothpaste, deodorant, make-up, sunscreen and perfume.

Anything meant to be swallowed, inhaled, injected or implanted is not a cosmetic. There are also some common borderline cases:

• Hand sanitiser: if its main purpose is to kill pathogens, it is a biocidal product and different rules apply.
• Insect-repellent body lotion: because of the repellent effect it is also a biocide, even if it contains care ingredients.
• Medicinal claims: if the product treats or prevents a disease, it is no longer a cosmetic.

Who is the responsible person, and is it you?

The responsible person is the EU-based company or person legally responsible for ensuring that the cosmetic product meets every requirement: without a responsible person the product cannot be sold (Regulation (EC) No 1223/2009, Article 4). Who that is depends on the product's route to market:

The brand owner is the responsible person because it places the product on the market under its own name (Article 4(6)). The distributor's role is smaller but not zero: before selling the product it must check the label, the language requirements and that the product has not expired (Article 6).

Can you appoint someone else as the responsible person? Yes: the manufacturer or importer can appoint another EU-based company by written mandate, provided it accepts (Article 4(3) and (5)).

Does translating the label make you the responsible person? No: translation alone does not make a distributor the responsible person (Article 4(6)). However, it is responsible for the accuracy of the translation.

How does a cosmetic product reach the market, step by step?

A cosmetic product reaches the market lawfully in seven steps, and the order matters: the safety assessment and the PIF must be ready before the CPNP notification.

1. Checking the formula. Every ingredient must be checked against the EU lists of prohibited, restricted and permitted substances (Regulation (EC) No 1223/2009, Annexes II–VI). These lists change several times a year.
2. Manufacturing under good manufacturing practice (GMP). Production must follow a documented quality system; the accepted benchmark is EN ISO 22716 (Article 8).
3. Safety assessment. A qualified expert writes the cosmetic product safety report (CPSR) (Article 10).
4. Compiling the PIF. Every document proving the product's safety and claims is brought together in one place (Article 11).
5. CPNP notification. The responsible person notifies the product online on the European Commission's portal (Article 13).
6. Label. The mandatory particulars go on the packaging, partly in Hungarian in Hungary (Article 19; Government Decree 246/2013, Section 2).
7. Notifying domestic manufacturing. If you manufacture in Hungary, the activity must be notified at least 30 days before production starts (Government Decree 246/2013, Section 4).

The work does not end at launch. If the formula, the label or a supply source changes, the safety assessment, the PIF and the CPNP data must also be updated. Serious undesirable effects (for example an allergic reaction requiring treatment) must be reported to the authority without delay (Article 23).

What is the PIF, and what does it contain?

The product information file (PIF; TID in Hungarian) is the cosmetic product's "personal file": a dossier holding, in one place, every document proving that the product is safe and that what is claimed about it is true (Article 11). It is the first thing an authority asks for during an inspection.

The PIF has five parts:

• a description of the product, so it is clear which product it covers,
• the safety assessment (CPSR),
• a description of the manufacturing method and the GMP statement,
• evidence for the claims, for example for "dermatologically tested",
• data on animal testing.

How long must the PIF be kept? For 10 years after the last batch was placed on the market. The PIF does not "expire"; it is a living document that must be updated whenever something changes.

Where must it be kept? At the address shown on the label, in a language easily understood by the authority (Article 11(3)). If the PIF is held in Hungary, its technical review is carried out by the National Centre for Public Health and Pharmacy (NNGYK) (Government Decree 246/2013, Section 5).

If you are not sure your existing PIF would survive an inspection, our cosmetics documentation page shows how we review it and fill in the missing parts.

What is the safety assessment (CPSR)?

The safety assessment is an expert report confirming that the cosmetic product is safe under normal and reasonably foreseeable conditions of use (Article 10). It is known as the CPSR (Cosmetic Product Safety Report) and has two parts (Annex I):

• Part A, the facts: exact composition, stability, microbiological quality, impurities and the effect of the packaging material, method of use, exposure (how much enters the body), the ingredients' toxicological profile, known side effects.
• Part B, the expert opinion: the conclusion on whether the product is safe, the warnings to appear on the label, the reasoning and the assessor's details.

Who can prepare it? A pharmacist, toxicologist, physician or specialist with a similar university degree (Article 10(2)). You cannot write it yourself without the relevant qualification.

Which laboratory tests does the safety assessment need?

Part A of the safety assessment relies on measured data, so most products need four tests (Annex I; Commission Implementing Decision 2013/674/EU):

• Stability testing: shows that the product does not change (colour, odour, texture, pH) until its expiry date.
• Microbiological testing: confirms that the product is not contaminated with bacteria or fungi.
• Preservative efficacy (challenge) test: confirms that the preservation protects the product during use; almost always needed for water-based products.
• Packaging compatibility: checks that the packaging does not interact with the product.

The assessor also relies on the raw material suppliers' documents: specifications and the raw materials' safety data sheets (SDS), which provide the hazard and purity data of the ingredients. Incomplete or outdated raw material SDSs also hold up the safety assessment.

What is the CPNP, and how does it differ from the PIF?

The CPNP (Cosmetic Products Notification Portal) is the European Commission's free online portal where the responsible person notifies the cosmetic product before placing it on the market (Article 13). One notification covers the whole EU; it does not need to be repeated country by country.

The two terms are often confused, but their roles differ:

• The CPNP is the notification: it tells the authorities and poison centres that the product exists and who is responsible for it.
• The PIF is the evidence: it proves that the product is safe and complies with the rules.

Among other things, the notification must state the product's category and name, the address where the PIF is kept, the country of origin, any nanomaterials and the frame formulation, and a photo of the label must be uploaded. The database is not public.

Is a CPNP notification enough to sell the product? No. The NNGYK explicitly stresses that a CPNP notification is not a sufficient condition for lawful sale: the safety assessment and the PIF must also be in place.

What must appear on a cosmetic label, and what in Hungarian?

The label must carry seven particulars, four of which must be shown in Hungarian in Hungary (Regulation (EC) No 1223/2009, Article 19; Government Decree 246/2013, Section 2).

The Hungarian text may appear on a supplementary label if it is clearly visible and cannot be removed. If a distributor translates a label element, according to NNGYK guidance this must also be recorded in the CPNP.

What can I claim about the product? Anything that is true and can be proven. Claims must meet six common criteria: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision-making (Regulation (EU) No 655/2013). A "dermatologically tested" or "hypoallergenic" claim therefore needs test results in the PIF.

What is mandatory only in Hungary?

In Hungary, four national requirements are added to the EU rules, all in Government Decree 246/2013 (VII. 2.):

1. Hungarian-language labelling for nominal content, durability, precautions and function (Section 2).
2. Notification of manufacturing: a domestic manufacturer notifies its activity to the competent district (Budapest district) office at least 30 days before production starts, and any changes within 30 days (Section 4).
3. National authority: the NNGYK, which also carries out the technical review of PIFs held in Hungary (Sections 3 and 5).
4. Reporting serious undesirable effects on the form published on the NNGYK website (Section 10).

On the market, the district office, the National Chief Medical Officer and the consumer protection authority may also carry out inspections (Section 4(1)).

What is changing in cosmetics regulation in 2026 and 2027?

The most important change in 2026 is fragrance allergen labelling: since 31 July 2026, new product units may only be placed on the market with labels based on the extended list, and the number of fragrance allergens that must be labelled has risen from 26 to 82 (Regulation (EU) 2023/1545).

A fragrance allergen must be labelled if it is present above 0.001% in leave-on products or above 0.01% in rinse-off products. A broader EU simplification package is also under way, which would introduce sell-off periods for prohibited substances; we will update this section once it is finally adopted.

What are the most common misconceptions?

The most common misconception is that a CPNP notification is an authorisation. In our experience, these misunderstandings cause the most gaps during an official inspection:

• "A CPNP notification is an authorisation." It is not: it is only one of seven steps; without the PIF and the safety assessment the product cannot be sold.
• "The contract manufacturer has taken care of everything." If your brand name is on the label, you are the responsible person and you must have access to the PIF.
• "The PIF only has to be prepared once." The PIF is a living document: it must be updated whenever the formula, sourcing or the rules change.
• "A natural ingredient is bound to be safe." Essential oils contain fragrance allergens, and some plant substances are on the prohibited list.
• "As a webshop I am not responsible for anything." Distributors must also check the label, the Hungarian language and the expiry date.

What does this look like in practice?

A typical case: a small Hungarian business launches an own-brand body lotion range, production is handled by a contract manufacturer, and sales start in its own webshop and a few drugstores. The company contacts us because the drugstore asks for the CPNP number and the responsible person's details at the very first meeting.

In such cases we first clarify that the responsible person is the brand owner, because its name goes on the label. We then request the formula and production data from the contract manufacturer, check the ingredients, and prepare the safety assessment and the PIF. Finally, we review the label and the claims, and complete the CPNP notification. The drugstore then receives an inspection-ready dossier.

How much does it cost to place a cosmetic product on the market?

The CPNP notification itself is free of charge: the European Commission's portal costs nothing. The real costs come from expert work and testing, which vary by product and formula:

• CPNP notification: HUF 0, the European Commission's portal is free of charge.
• Safety assessment (CPSR Parts A and B) and PIF: typically HUF 150,000–250,000 per product; simpler products (such as oils or soaps) sit at the lower end, complex emulsions at the upper end.
• Stability and compatibility testing: approx. HUF 50,000–120,000.
• Microbiological purity testing: approx. HUF 25,000–45,000.
• Preservative efficacy (challenge) test: approx. HUF 80,000–150,000; usually not needed for anhydrous products.
• Label and claims review: approx. HUF 30,000–50,000 if not included in the expert package.
• Claim substantiation: for example dermatological or efficacy testing if the label carries such a claim; the price depends on the test.

For a product range (for example the same cream in several scents), shared data usually lowers the cost per product. Prices are indicative and exclude VAT. We quote a precise price once we have seen the formula and the existing documents.

How do we help?

We prepare the full regulatory documentation for your cosmetic product and complete the notification, so the product can go to market with confidence. Specifically, we:

• check the formula and the ingredients,
• prepare the safety assessment (CPSR Parts A and B),
• compile the PIF, including manufacturing and quality assurance data,
• review the label and the substantiation of claims,
• complete the CPNP notification and track changes to the product,
• support the responsible person and help answer enquiries from the authorities.

We work with manufacturers, owners of contract-manufactured brands, importers and webshops. Our expertise is built on 25 years of regulatory and consulting experience: we know what an inspector looks at first.

If you have a product getting ready for launch, or you are unsure whether your existing documentation would survive an inspection, request a quote for cosmetics compliance. We reply within one working day; you can also reach us at consulting@innovatox.hu or on +36 20 445 4888.

Glossary: key terms in cosmetics regulation

• Responsible person: the EU-based company or person legally responsible for the cosmetic product's compliance.
• PIF (product information file; TID in Hungarian): the product's dossier with every document proving its safety and claims.
• CPSR (cosmetic product safety report): the safety assessment written by a qualified expert, with Parts A and B.
• CPNP: the European Commission's cosmetic products notification portal.
• INCI: the standard international naming of ingredients on the label.
• GMP: good manufacturing practice; for cosmetics, the EN ISO 22716 standard.
• Claim: any statement about the product on the label or in advertising.
• CMR substance: a carcinogenic, mutagenic or reprotoxic substance; generally prohibited in cosmetics.
• NNGYK: the National Centre for Public Health and Pharmacy, the Hungarian cosmetics authority.