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Montenegro Cosmetic Product Registration

COSMETIC REGISTRATION IN MONTENEGRO

Regulatory Authority

http://Ministry of Health (www.gov.me)

Local Regulation

Law on Cosmetic Products (OG n. 24/2019)

Who can Register? 

  • Manufacturer
  • Distributor

Data to be Communicated

Process to Register Cosmetic Product

For a cosmetic product to be introduced into the Montenegrin market, the company is obligated to provide necessary documentation to both the Montenegrin Ministry of Health and the European Commission, aligning with the standards set by the EU. Despite the legislation not expressly stipulating the requirement for a designated national responsible person, companies are expected to guarantee the conformity of their products with legal mandates. 

This entails having a local point of contact established to address any potential concerns or inquiries. Compliance with regulatory obligations ensures that products meet the prescribed safety and quality standards, safeguarding consumer health and interests.

Therefore, while the specific mention of a responsible national person may be absent, companies are still bound to fulfil these responsibilities to ensure the smooth entry and distribution of their cosmetic goods in Montenegro, adhering to the broader regulatory framework set forth by the European Union.

Additional Information

Labelling requirements: Cosmetic labelling regulations necessitate the inclusion of specific information on product labels. Manufacturers or distributors must be clearly identified along with contact information. Cosmetic ingredients must be listed in the order of their presence in the formula, identified by their botanical names. 

Additionally, the label must display the weight of the product in both standard and metric units as required by the department of weights and measures. The choice of label material often depends on the nature of the packaging and the method of filling.

Animal Testing: At present, Montenegro has not instituted a ban on animal testing for cosmetic items, permitting the utilization of data from such testing or its components, provided such tests were not conducted within the EU. Nonetheless, the Montenegrin government has affirmed its dedication to harmonizing its legal framework with that of the EU gradually, which entails the eventual cessation of animal testing for cosmetics. 

Furthermore, Montenegro’s cosmetic regulations authorize products that have undergone alternative testing methods to be labelled accordingly, potentially incentivizing companies to transition away from animal testing. This aligns with broader global trends favouring cruelty-free practices and underscores Montenegro’s intent to embrace ethical standards in the cosmetic industry. 

As Montenegro moves towards convergence with EU guidelines, the emphasis on non-animal testing methodologies signifies a progressive stance aimed at promoting both consumer welfare and ethical considerations within the cosmetics sector.