Cosmetic products

Serbia and EU cosmetic legislation consulting service

Before going out on the market, every cosmetic product must be subjected to a specific cosmetic legislation. With Serbia’s adoption of the new Law on General Use Items and the Bylaw on Cosmetic Products in 2019, the cosmetic industry is being harmonized with the regulations of the European Union. With that being done, there are a lot of new obligations for the cosmetic products manufacturers and distributors, and they have to be fully compliant until April 2023. We help you deal with regulatory challenges, if you are a manufacturer, importer or distributor of cosmetic products and raw materials in Serbia and EU.

Responsible Person Role

According to the Law on Items of General Use, only products for which a Responsible Person (RP) has been appointed, can be placed on the Serbian market. Importer of cosmetic products or manufacturer of cosmetic products located outside of Serbia can designate as Responsible Person a legal or natural person in Serbia. We provide this service - role of the Responsible Person, for the Serbian market. If you are a manufacturer of cosmetic products located in Serbia willing to export to the EU we will introduce you to a trusted partner that can take the Responsible Person role for the EU market.

Product Information File - PIF

Starting from April 2023, every cosmetic product placed on the Serbian market must have supporting Product Information File - PIF. The designated Responsible Person has an obligation to make sure that the Product Information File is made and maintained in accordance with the legislation, and in case of inspection to make it available in short notice. The Most important part of the Product Information File is the Cosmetic Product Safety Report, done and signed by an expert (safety assessor) with academic qualifications defined by the law. We offer a service of making and maintaining your Product Information File and we help with collecting all necessary documents.

Safety Data Sheet (SDS) for cosmetic ingredients

Safety Data Sheet (SDS, previously called Material Safety Data Sheet - MSDS) is a document containing a broad range of information on the composition, physical and chemical properties, environmental and health effects of the substance or a mixture, and is providing the instructions on their safe usage, storage and disposal. Although it is not mandatory for cosmetic products to have a Safety Data Sheet, making one is seen as a good business practice, considering it can be helpful with providing valuable information on handling, storage and transport of cosmetic products, help with identification during the import and export customs procedures, giving the information on presence of classified substances etc. Safety Data Sheet for a substance or a mixture on the Serbian market must be written in Serbian language in accordance with the Serbian Law on Chemicals, regardless of the country of origin. For the cosmetic raw materials and the cosmetic products manufactured in Serbia, we make Safety Data Sheets, and for imported cosmetic products and raw materials we do their translation and adjustment to Serbian regulation.

Cosmetic Product Safety Report (CPSR)

Cosmetic Product Safety Report is the crucial part of the Product Information File designed to demonstrate that the cosmetic product is safe for use. It contains a broad range of toxicological information on raw materials and product itself necessary for the safety evaluation. Cosmetic Product Safety Report is done and signed by the safety assessor with academic credentials defined by the law. We offer a service of making a Cosmetic Product Safety Report, and we help you gather all the required documents.

Testing of cosmetic products and raw materials

If you are a manufacturer of the cosmetic products or raw materials, based on the type of your product we can lead you through the mandatory and optional testing procedures. In cooperation with accredited laboratories we can help you organize:

  • Microbiology testing
  • Stability and Compatibility test
  • Challenge test 
  • Heavy Metals Analysis
  • Pesticides Analysis 
  • Allergens Analysis
  • and more
Cosmetic products formulation consultancy

It would be necessary to consider the safety aspect of the cosmetic product during the process of development and formulation of the product. There are a number of risks to be taken into account  - quality of the raw materials, production method of the raw materials, ingredients compatibility, product and packaging compatibility, unwanted interactions, regulatory restrictions etc. We provide consulting services during all phases of the product development, we evaluate raw materials and final formulation, we check regulatory requirements and restrictions.

Maintaining and updating of the Product Information File

The Product Information File must be kept for the period of 10 years following the date on which the last batch of the cosmetic product was placed on the market, and  has to be shown to the authorities upon request. During that period, it is necessary to update the Product Information File with every eventual change relevant to the product (ingredients, manufacturing process..), and  with the information coming from the surveillance of the product on the market. Product Information File must be kept by the Responsible Person. We offer a service of the Responsible Person role for the Serbian market, we make and maintain Product Information File, and we cooperate with the local authorities.