Правна рамка за козметични продукти в България и ЕС

Placing a cosmetic product on the market may at first glance appear to be primarily a commercial and marketing process. In practice, however, every cream, serum, shampoo or other cosmetic product is subject to a substantial regulatory framework.

For businesses, this means that a number of requirements must be met even before the product reaches consumers - from designating a responsible person and assessing safety to labelling, advertising claims and the documents that must be available during an inspection. Lack of familiarity with the regulations entails serious risks of administrative sanctions, the blocking and withdrawal of goods by the Regional Health Inspectorate, unfair competition disputes before the Commission for Protection of Competition, and lasting damage to the business.

When is a product considered a cosmetic product?

The main legal framework at European Union level is contained in Regulation (EC) No 1223/2009 on cosmetic products, supplemented by the applicable provisions of the Health Act. To be classified as a cosmetic product, a product must meet two main criteria simultaneously.

First, it must be intended to come into contact with the external parts of the human body - for example, the epidermis, hair, nails or lips - or with the teeth and the mucous membranes of the oral cavity.

Second, its primary purpose must be exclusively or mainly to clean, perfume, change appearance, protect, keep in good condition or correct body odours.

No Licence is required, but there are mandatory steps before placing the product on the market

Cosmetic products are not subject to a prior licensing regime before being offered on the market, but there are obligations that must be fulfilled.

The first step is to designate a “Responsible Person” established in the EU, which, in the case of imported products, is most often the importer. Before the product is offered to consumers, the Responsible Person must ensure that a Safety Report is prepared by a qualified specialist.

Information about the product - including details of the manufacturing method, evidence supporting the claimed effect and compliance with Good Manufacturing Practice - is compiled in a “Product Information File” and kept for 10 years after the last batch is placed on the market. Where the Responsible Person’s address is in Bulgaria, the file must be readily accessible to inspectors of the Regional Health Inspectorate in Bulgarian.

In addition, the product must be notified through the centralised European portal, and its safety cannot be demonstrated through animal testing, which is subject to a complete ban in the EU.

What must the label contain?

Labelling is one of the most visible and practically important aspects of a cosmetic product’s compliance. Under the established regulatory requirements, cosmetic products may be made available on the market only if mandatory information appears on their primary and secondary packaging in indelible, clear and easily legible lettering. This information includes the name and address of the Responsible Person, and, in the case of imports, the country of origin must also be specified.

The packaging must state the nominal content by weight or volume, with exemptions for samples, single-use packs and products containing less than 5 grams or 5 millilitres.

As regards durability, products with a minimum durability of up to 30 months must indicate the date of minimum durability, preceded by the relevant symbol or the words “best used before the end of”, whereas products with a durability exceeding 30 months must indicate the period after opening (PAO symbol) during which the product remains safe for use.

The label must also include specific precautions and warnings for use, the manufacturing batch number and the function of the product, unless that function is entirely clear from its presentation.

How should the Ingredients be listed?

The list of ingredients, preceded by the term “ingredients”, may appear on either the primary or secondary packaging and must be arranged in descending order of their weight at the time they are added.

Where, due to small size or practical considerations, it is impossible to fit the precautions or ingredients on the packaging, an enclosed leaflet, label or card marked with the “open book with a hand” symbol may be used; for soaps and small products, the information is placed in the immediate vicinity of the point of sale.

Advertising - what can and cannot be promised?

The legal requirements do not end with manufacturing and labelling. The way in which the product is advertised is also regulated. All claims relating to cosmetic products - including messages on websites, in advertisements or on social media - must meet the common criteria under Regulation (EU) No 655/2013.

First, the messages must comply with the law, which means that compliance with standard legal requirements cannot be presented as a unique advantage, nor may false approval by a public authority be claimed. Their truthfulness is also crucial - if a specific ingredient is advertised, it must actually be present in the formulation, and subjective opinions must not be presented as proven facts. Every claimed effect requires scientific substantiation, supported by verifiable and up-to-date methodologies for the specific product. Advertising must be entirely honest, without exaggerating the product’s effects or presenting properties common to a category as exclusive. Last but not least, messages must be guided by fairness, remaining objective and not denigrating competitors or legally used ingredients. All of this serves one ultimate purpose - enabling an informed decision through a clear, accurate message tailored to the audience, helping consumers make a conscious and safe choice.

Social media is also part of the regulatory risk

Marketing content on Instagram, TikTok, Facebook or other social networks is not outside the scope of the rules simply because it is published in a more informal format.

Where a post, video, story or influencer communication makes claims about the effects, qualities or composition of a cosmetic product, those claims must meet the same requirements of truthfulness and substantiation. It is therefore good practice for legal review to cover not only the label but also advertising concepts and key marketing messages before publication.

Who regulates cosmetic products in Bulgaria?

In Bulgaria, supervision is carried out by the Ministry of Health and the Regional Health Inspectorates, whose inspectors have the right to conduct inspections, take samples, issue mandatory instructions and, where violations are identified, draw up Statements of Establishment of Administrative Violations (AUAN).

What does All this mean for the Cosmetics Business?

Successfully launching and managing a cosmetic product requires legal and regulatory requirements to be integrated into the product development and positioning process from the outset.

In practice, businesses need to check not only the formula and safety but also the Responsible Person, the product file, the label, the mandatory information and the way in which the product will be advertised. This allows potential problems to be identified before the product reaches the market.

The KGK Law Firm team offers comprehensive legal assistance to cosmetics businesses, including audits of products, labels and marketing campaigns, drafting contracts, representation before the Regional Health Inspectorates and the Commission for Protection of Competition, as well as defence against sanctions and unfair competition.

If you develop, import or offer cosmetic products and wish to check whether your product and the communications relating to it comply with the applicable requirements, contact us.