Are you thinking about launching your own line of cosmetic products?
Starting your own cosmetic line has become an attractive option for many entrepreneurs—more and more brands are emerging in the market, and consumers are becoming increasingly demanding in terms of effectiveness, ingredients, and sustainability of cosmetic products. For many, this is the ideal opportunity to combine creativity and entrepreneurial spirit in the beauty industry.
In addition to understanding the market, competition, and trends, it is essential to be familiar with the legal framework governing the product from its inception to its market launch. From ingredient selection, through product testing, ensuring safety and quality requirements, to market placement and brand protection—each step requires knowledge of legal standards.
Cosmetic product market
As we mentioned earlier, launching your own cosmetic line has become a very popular business move recently. This trend is confirmed by the figures—according to data from the Serbian Chamber of Commerce from May 2024, the value of cosmetic product exports from Serbia in the first five months reached 36.8 million euros, an 8% increase compared to the same period last year.
This growth is not new and has been observed in previous years as well. According to data from 2023, total exports of cosmetic products from Serbia were nearly 40% higher than in 2022. In addition to regional markets, Serbian cosmetic products can be found in almost all parts of the world. This trend indicates that the cosmetic industry in Serbia is on an upward trajectory and is becoming an increasingly significant player on the global stage.
Legislative framework
The regulation of cosmetic products in Serbia was fully aligned with EU regulations in 2023. As early as 2019, the Law on Consumer Products and the Regulation on Cosmetic Products were enacted, with a transitional period for full implementation ending in April 2023.
A cosmetic product manufactured in Serbia must meet the same standards as a product manufactured in the European Union.
Therefore, every cosmetic product must comply with the applicable regulations before being placed on the market. In addition to the aforementioned Law and Regulation, it is important to consider the rest of the legislative framework, which includes, for example, the Law on Chemicals, the Law on General Product Safety, the Law on Sanitary Supervision, the Regulation on Health Safety Conditions for Consumer Products, and the guidelines SRPS EN ISO 22716 and SRPS EN ISO 9001.
As stated in the Law on Consumer Products, cosmetic products placed on the market must be safe for human health when used under normal or reasonably foreseeable conditions, considering especially the appearance of the product (plus compliance with regulations concerning misleading products), product labeling, instructions for use and disposal, and any other information provided by the responsible person. We will explain who the person responsible is later.
Where to start?
You probably already have an idea of the type of cosmetic product you want to produce and market. However, let’s start with the basics and the definition of a cosmetic product.
A cosmetic product refers to substances (chemical elements and their compounds in their natural state or obtained through the manufacturing process) or mixtures (a blend or solution consisting of two or more substances) intended to come into contact with the external parts of the human body or with teeth and the mucous membranes of the mouth, exclusively or primarily for cleaning, perfuming, changing their appearance, correcting body odor, or protecting and maintaining them in good condition. If the substances or mixtures are intended for ingestion, inhalation, injection, or implantation into the human body, they are not considered cosmetic products.
The Regulation on Cosmetic Products defines the manufacturer as a legal entity, entrepreneur, or individual under whose name or brand the cosmetic product is placed on the market, whether the product is made by them or if the product is designed or manufactured by someone else on their behalf. This second situation refers to the manufacturing agreement, where one legal entity enters into an agreement with another legal entity to produce a product or an entire line of products in its name.
At this stage, we will not discuss the manufacturing process, and all the legal specifications related to production but will focus on the situation where you have opted for contract manufacturing, which is a common choice today.
If you haven’t already, the first step is to register your business or choose the legal form under which you will operate. You can register as an entrepreneur or opt for a form of business entity.
You can learn more about this here: ‘How to prepare for starting a company?’.
Who is the responsible person and what are their obligations?
Only cosmetic products for which a legal or natural person in the Republic of Serbia has been designated as the responsible person can be placed on the market. If the cosmetic product is manufactured in Serbia and is not subsequently exported and re-imported into Serbia, the responsible person is the manufacturer whose headquarters are in the Republic of Serbia. We have already provided the definition of the manufacturer above.
The manufacturer can authorize, in writing, a person established in Serbia to act as the responsible person. If the manufacturer is based outside the Republic of Serbia, and the product is manufactured in Serbia but not exported and then re-imported into Serbia, the manufacturer must authorize a legal entity established in Serbia as the responsible person, in writing.
The responsible persons must ensure compliance with the provisions of the Law on Consumer Products and the Regulation on Cosmetic Products related to product safety, good manufacturing practice principles, safety assessment, product information dossier, sampling and analysis, traces of prohibited substances, reporting of serious adverse effects, labeling requirements, and more.
If the responsible person believes or has reason to believe that a cosmetic product does not comply with legal regulations, they must immediately take corrective actions, which may vary depending on the case. If the cosmetic product poses a risk to human health, the responsible person must notify the relevant authorities in the EU member states where the product is available to consumers, as well as the EU member state where the product information dossier is easily accessible.
Responsible persons in Serbia must cooperate with the relevant Ministry and, upon request, provide all necessary data and documentation to prove the compliance of certain aspects of the product.
When is the distributor the responsible person?
A distributor is considered the responsible person when they place a cosmetic product on the market under their name or brand, or when they modify a product that has already been placed on the market in a way that may affect its compliance with applicable requirements. The law specifies additional obligations for distributors when delivering a cosmetic product to the market.
What is the Product Information File (PIF)?
The Product Information File (PIF) contains regularly updated data about the cosmetic product, including a description of the product, a safety report, a description of the manufacturing method, a declaration of compliance with good manufacturing practices, evidence supporting any claims about the product’s effects (if justified by the nature of the product), and details about any animal testing conducted by the manufacturer, its representatives, or suppliers, including any animal testing done to meet regulatory requirements in other countries.
Once the cosmetic product is placed on the market, the responsible person must retain the Product Information File (PIF) for ten years from the date the last batch of the product was placed on the market and must ensure that the file is easily accessible to sanitary inspectors.
Regarding information that constitutes the manufacturer’s business secret, the sanitary inspector must act in accordance with the Law on Protection of Business Secrets.
What is the Declaration of Compliance with Good Manufacturing Practice?
Compliance with good manufacturing practice is presumed when production is in accordance with relevant harmonized standards.
The responsible person, or the manufacturer in the Republic of Serbia, signs this Declaration. The documentation required from the responsible person includes, for example, evidence of an established quality management system (ISO 9001), proof of the appointment of a responsible person for quality assurance, the manufacturer’s organizational chart, raw material incoming inspection, evidence of established procedures for handling complaints/claims, internal controls, and more.
Contracts with accredited laboratories
In accordance with SRPS EN ISO 22716, it is also necessary to secure contracts for laboratory testing services and specific health safety requirements for finished products, including tests for microbiological purity, equipment, and staff, as well as the implementation of mandatory pest control, disinfection, and rodent control.
The manufacturer must enter into agreements with accredited laboratories, which include accredited private laboratories or Public Health Institutes. These institutions must be authorized by the Ministry of Health.
What must the product documentation contain?
This documentation demonstrates that the cosmetic product is health-safe and includes specific information.
First, it must contain details about the qualitative and quantitative composition of the product. The qualitative composition refers to the chemical names of substances and their intended purpose. For the qualitative composition, you should refer to the International Nomenclature of Cosmetic Ingredients (INCI), the European Inventory of Existing Commercial Chemical Substances (EINECS), or the European List of Notified Chemical Substances (ELINCS).
The documentation should also contain the quantitative composition if the substances used are restricted, or if the active substance places the product in another category.
Next, the documentation must include information about the physical and chemical characteristics and stability of the cosmetic product. These data refer to the characteristics of the substances or mixtures, as well as the cosmetic product as a whole.
Additionally, the documentation must contain data on microbiological quality, information about the packaging, details regarding the normal and intended use of the product, and information about undesirable effects and serious adverse effects.
What shouldn’t a cosmetic product contain?
Our Regulation specifies what a cosmetic product must not contain, for example, substances banned in cosmetic products, as well as colors, UV filters, and preservatives not listed in the appendices of the Regulation.
The use of substances classified as carcinogenic, mutagenic, or toxic is prohibited in production, with certain prescribed exceptions.
Regarding heavy metals, the cosmetic product (calculated per 1 kg) must not contain more than 3 mg of cadmium and arsenic, more than 1 mg of mercury, and more than 10 mg of lead and nickel, with one exception related to skin care products for the eye area if the product contains thiomersal or phenylmercury salts.
What is the Declaration and what should it contain?
All cosmetic products marketed in Serbia must have a declaration in the Serbian language. The declaration must appear on both the primary and secondary packaging.
The declaration must contain the data prescribed by the Regulation, such as the name and address of the responsible person, the country of origin, net content, the minimum shelf life or a ‘period after opening’ (PAO) symbol if the minimum shelf life exceeds 30 months, usage instructions, warnings, a control or reference number for identification, intended use, and the product’s ingredient list.
Claims (e.g., text, logos, symbols, images, and other labels) that explicitly or implicitly describe the characteristics or functions of the cosmetic product must comply with the provisions of the Regulation and can be used when labeling, marketing, or advertising the product. The responsible person must ensure that the text of the claims complies with the common criteria for claims and is supported by documentation proving the claim about the product’s effects.
Placing a Cosmetic Product on the EU Market
To place a product on the EU market, a legal or natural person with a registered address in the EU must be designated as the responsible person.
The EC Regulation on Cosmetic Products (No. 1223/2009) applies, and it is necessary for the safety report to be compiled in accordance with Annex 1 of this Regulation. Additionally, the responsible person must notify the product through the CPNP (Cosmetic Products Notification Portal).
Note: This text is not legal advice but the personal opinion of the author.
