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Legislation and regulations in the cosmetic industry


In our country, the cosmetic industry has undergone significant evolution in recent decades, reflecting both changes in consumer preferences and adaptation to international standards in the field. This increasingly dynamic and competitive sector has been shaped and essentially influenced by strict regulations aimed at ensuring the quality and safety of cosmetic products available on the market.

In light of legal provisions such as those outlined in Law no. 178/2000 on cosmetic products, the cosmetic industry in Romania is committed to a constant effort to ensure that products made available to consumers meet the highest standards of quality and safety. This legislation for cosmetics in Romania, along with applicable European regulations, forms the essential basis for conducting activities in accordance with established requirements and norms.

Regulations in the cosmetic industry serve not only the interests of the industry but, more importantly, have the role of protecting the health and safety of consumers. The presence of rigorous standards regarding verification procedures, testing of composition, efficacy, and labeling of cosmetic products ensures that cosmetics meet essential standards before being introduced to the market.

By strictly adhering to regulations, the cosmetic industry in Romania promotes transparency and the responsibility of cosmetic manufacturers towards consumers.

Cosmetic Legislation in Romania

In the dynamic context of the cosmetic industry in our country, legislation represents the basic pillar that provides the necessary framework for the correct and safe functioning of this sector.

Cosmetic legislation in Romania includes rules and regulations that align with those at the European level. National authorities play a crucial role in ensuring compliance with cosmetic laws. The Ministry of Health, together with the National Consumer Protection Authority, are the main entities involved in implementing and monitoring compliance with regulations. These entities conduct control activities, issue approvals, and cooperate with other European authorities to ensure coherence in the single market.

Regulations in the cosmetic industry establish clear requirements regarding the ingredients used, manufacturing processes, labeling of cosmetic products, and transparent information to consumers through proper marketing. By applying these regulations in the cosmetic industry, the aim is to prevent incorrect commercial practices and ensure fair competition in the industry.

Basic Requirements for Cosmetic Products

In accordance with cosmetic legislation in Romania, products are subjected to rigorous requirements concerning the definition, classification, labeling, and packaging of cosmetic products. These requirements ensure transparency, safety, and adequate information for consumers.

Definitions and Classifications

Romanian legislation defines cosmetic products as substances or mixtures applied to the surface of the human skin, nails, hair, lips, or oral cavity, with the purpose of cleaning, perfuming, modifying their appearance, protecting them, maintaining them in good condition, or correcting body odor.

These products are classified into a diverse range, including creams, emulsions, lotions, gels, perfumes, hair care products, makeup products, and many more. The precise definition and classification of each type of cosmetic product are established in accordance with the rules imposed by Romanian cosmetic legislation and are essential for compliance with specific norms and regulations.

Mandatory Studies and Tests

Cosmetic products must comply with safety and efficacy standards established by cosmetic legislation in Romania, aligned with European standards. These requirements aim to ensure that products intended for human use are safe for health and that they fulfill the purposes for which they were created. The studies and tests conducted must provide clear evidence regarding:

  1. Microbiological and physico-chemical product safety: Each ingredient in the master formula is carefully checked, analyses are performed to verify microbiological safety, the validity of the product when closed, and the product after opening, mandatory physico-chemical tests for placing the new product on the market.
  2. Compatibility with the skin: Cosmetic products must be tested to ensure that they do not cause allergic reactions or skin irritations. These tests focus on individual ingredients and their combinations to assess their impact on skin health. Tests are conducted under the supervision of a dermatologist and only on human subjects.
  3. Stability and durability: Cosmetic products must retain their initial qualities throughout the entire shelf life. Stability studies evaluate how products react to factors such as light, heat, or oxygen, to establish the storage conditions of the product in the final packaging throughout the shelf life, as well as after opening.
  4. Efficacy and performance: To ensure that products meet the promises made to consumers, efficacy studies test their capabilities, such as skin hydration, water resistance of products, or anti-wrinkle effects. This type of test is called a claim test, ensuring correct marketing and presenting customers with the effect promised by the product.

Cosmetic manufacturers in Romania have the responsibility to initiate, coordinate, and bear the costs of the necessary studies and tests to demonstrate the compliance of cosmetic products with regulations. This process involves:

  1. Selecting accredited laboratories: It is crucial for manufacturers to collaborate with accredited laboratories to perform studies and tests in line with specific requirements. Choosing reputable laboratories contributes to obtaining valid and internationally accepted results.
  2. Documenting and presenting results: Manufacturers must document and present the results of studies and tests in product dossiers. This information is often requested by regulatory bodies and may be required for subsequent checks or verifications.
  3. Continuous knowledge updating: As research and technology evolve, manufacturers are encouraged to constantly update their knowledge to stay abreast of the latest requirements and testing methods.

By rigorously adhering to safety and efficacy requirements and by assuming responsibility for conducting mandatory studies and tests, cosmetic manufacturers in Romania contribute to the development of a transparent, safe, and confident industry. These practices ensure that products reach the market only after careful assessments and comply with the highest quality standards.

Labeling of Cosmetic Products and Packaging According to Norms

Proper labeling and secure, efficient packaging are essential aspects for compliance with regulations. On the label of each cosmetic product, essential information such as:

  • The manufacturer’s name
  • Manufacturer’s address or the person responsible for placing on the market/distributor
  • Country of origin
  • Quantity of the finished product
  • Instructions for use
  • Special precautions for use and necessary warnings
  • Function of the cosmetic product, possibly a description of the product and its ingredients
  • Batch number and expiration date, and PAO (period after opening)
  • Full list of ingredients, according to INCI, and product registration number
  • Product storage conditions

These requirements ensure that all consumers are adequately informed and can make informed choices when purchasing and using cosmetic products.

By imposing these basic requirements, Romanian authorities create a regulatory framework that promotes high standards in the cosmetic industry. Proper labeling of cosmetic products and appropriate packaging are the keys to a trusting relationship between manufacturers and consumers, ensuring that cosmetic products marketed in Romania comply with the highest standards of quality and safety for use.

Manufacturer’s Responsibility

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Producers of cosmetic products have the following legal obligations:

  1. Compliance with Production Standards:Producers must manufacture cosmetics in accordance with the norms and standards established by Romanian cosmetic legislation. This involves using safe and approved ingredients, adhering to good manufacturing practices, and maintaining a hygienic working environment.
  2. Ensuring Quality and Safety: Producers are responsible for the quality and safety of cosmetic products. They must implement quality procedures and controls to prevent risks and ensure that products meet established standards.
  3. Labeling of Cosmetic Products: They must ensure proper labeling of cosmetic products, complying with the requirements imposed by European cosmetics legislation. Information on the label must be clear and easily understandable for consumers.
  4. Documentation Preservation: Producers are obligated to keep complete and up-to-date documentation for each manufactured cosmetic product. This documentation may be requested during inspections or verifications by competent authorities.

Responsible Distribution of Cosmetic Products

Close collaboration between producers and distributors ensures that cosmetic products maintain their quality and safety throughout the entire process, from production to distribution and to the consumer.

Distributors of cosmetic products also play a crucial role in ensuring that these products reach consumers in optimal conditions. The main aspects of responsible distribution include:

  1. Proper Storage: Distributors must ensure adequate storage conditions for cosmetic products to prevent their deterioration and comply with the storage conditions provided by the manufacturer. For example, products sensitive to high temperatures or direct light exposure must be handled and stored appropriately.
  2. Safe and Efficient Transport: Distributors are responsible for ensuring the safe transport of cosmetic products to points of sale. Proper packaging and careful handling during transport contribute to maintaining the quality of products.
  3. Respecting the Supply Chain: Distributors must collaborate with producers and suppliers to ensure the respect of the entire supply chain. Efficient communication and continuous monitoring contribute to preventing issues related to the quality or compliance of cosmetic products.
  4. Consumer Information: Distributors have a role in providing correct information to consumers regarding the use and benefits of cosmetic products. They must offer assistance and respond to questions to facilitate a positive experience for consumers.

Compliance with Cosmetic Products: How We Help Clients at Pop Chemistprod

As experts in private label cosmetic product manufacturing, we always ensure that our products fully comply with the regulations in the Romanian cosmetic industry. We are committed to supporting clients and distributors in achieving and maintaining compliance. Our cosmetic compliance consulting services are designed to provide support in all aspects related to specific regulations in the cosmetic field. Here’s how we can help:

  • Compliance Assessment: At Private Label, we offer more than simple cosmetic compliance consulting. We conduct thorough assessments to verify if products meet specific legislative requirements. This process involves analyzing ingredients and final formulations, manufacturing processes, and associated documentation.
  • Documentation Development: We also assist clients in preparing the necessary documentation, including technical dossiers and labeling information. We closely collaborate with them and competent authorities to ensure that all required details are in accordance with legal requirements.
  • Labeling and Packaging Consultancy: We provide guidance in the cosmetic product labeling process, ensuring that information is presented clearly and complies with legal requirements. This service includes both the design aspect and all elements required by legislation, such as the ingredient list, usage instructions, and relevant symbols.

The importance of compliance in the Romanian cosmetic industry cannot be underestimated. Adhering to regulations in the cosmetic industry is essential not only to avoid sanctions but also to ensure the safety and trust of consumers. If you need a long-term partner to support you from the ideation stage, creating and verifying new formulas, raw material selection, obtaining market placement approvals, and even distribution, we encourage you to get in touch with us. We ensure that the entire communication will be transparent and confidential, that the resulting products will be made only with quality ingredients, and that they comply with all relevant laws in the industry.

Feel free to contact us either via email: or by phone: 0751 071 043!