October 14, 2024
The rules for introducing cosmetic products to the European Union market are fully contained in Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 concerning cosmetic products. This regulation establishes clear and detailed provisions, preventing divergent interpretations by Member States. It also ensures the introduction of uniform regulations throughout the Community at the same time [1].
It is important to note that this document only applies to cosmetic products and not to medicinal products, medical devices, or biocidal products. The distinction is made based on the definition provided in Article 2 of the regulation: "A 'cosmetic product' means any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips, and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view to exclusively or mainly cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors" [2].
Below are the key aspects of the regulation, which will be briefly discussed in the article:
1. Safety, responsibility, free movement
2. Safety assessment, product documentation, notification
3. Restrictions on certain substances
4. Animal testing
5. Consumer information
6. Market surveillance
As we know, a cosmetic product introduced to the market should be safe for health and, according to Directive 87/357/EEC, should not resemble products intended for uses other than the actual purpose [3]. Before launching a product, appropriate labeling must be ensured. The responsible person, whether the manufacturer or importer, takes full responsibility for the product, the information on the label, and its safety. If the cosmetic product meets all the requirements of the regulation, no Member State may restrict the distribution or availability of the product placed on the market.
Before placing a cosmetic product on the market, the manufacturer is required to conduct a series of tests, such as microbiology, preservative testing, stability, and compatibility of the mass with the packaging. Additional tests, such as dermatology and application tests, are also recommended, allowing the manufacturer to create an ideal marketing claim and tailor the product to the appropriate consumer group.
The next step is to create a Safety Report, which evaluates the safety of substances and cosmetic products intended for use. This report is prepared by a qualified Safety Assessor. It must include Part A, which covers product information (individual ingredients and packaging material), toxicological evaluation of ingredients, exposure assessment, and the results of the aforementioned tests. Part B contains conclusions and qualifications.
The final step, which must be completed no later than the day the product is placed on the market, is registration in the Central Products Notification Portal (CPNP). This portal was created to standardize the system for registering cosmetics in the EU and to efficiently transmit information to control authorities, such as the State Sanitary Inspectorate and Trade Inspection. It has been mandatory since July 11, 2013. The following must be registered:
- Full product name in all languages
- Responsible person
- Product category
- Product concentration range
- Labeling
- Packaging - external appearance of the product [4].
Regulation (EC) 1223/2009 of the European Parliament and Council includes annexes listing substances prohibited for use in cosmetics (Annex II), materials used in specific concentration limits and allergens (Annex III), and a list of colorants approved for use in cosmetic products with specified concentration limits and specific uses for particular body parts (Annex IV).
Since 2004, there has been a ban on testing cosmetic products on animals within the European Union. In 2009, a ban on testing cosmetic raw materials on animals was introduced, and since 2013, there has been an absolute ban on the sale of products where either the raw materials or the finished product were tested on animals.
An important aspect is proper labeling of the cosmetic product. The label or outer packaging (e.g., carton) must include elements such as:
- Precise manufacturer data
- Country of origin
- Nominal quantity [g/ml]
- Expiration date/PAO
- Instructions for use, warnings, product function
- Batch number
- INCI nomenclature – product ingredients.
The manufacturer and distributor are required to report any adverse effects resulting from the use of a cosmetic product to the competent authorities of the Member State where the adverse effect occurred. The report must include the data the company has regarding potential serious adverse effects, the name of the cosmetic product, and information about any corrective actions taken if they were implemented [2].
In addition to the regulation, every cosmetic manufacturer must also comply with Good Manufacturing Practice (GMP). This key standard contains a set of rules aimed at ensuring high standards at every stage of production, from the purchase of raw materials to the sale of the product. GMP controls the entire production cycle, including the equipment, employees, training, disinfection, maintenance, etc. [5].
The final element a manufacturer must have before introducing a cosmetic product to the market is the Product Information File (PIF), as required by Article 11 of Regulation (EC) No 1223/2009. This file contains all documents related to the manufacture of the product, including the cosmetic product description, safety report, information on production methods, test results, proof of claimed effects, and data on animal testing.
As outlined above, every manufacturer, distributor, or importer must meet several key elements before introducing a product to the market. Knowledge of the regulation, proper and thorough documentation, and production in accordance with GMP are the starting points for expanding the market and introducing innovative, effective, and above all, safe products that consumers can use in their daily care.
[1] https://sip.lex.pl/akty-prawne/dzienniki-UE/rozporzadzenie-1223-2009-dotyczace-produktow-kosmetycznych-wersja-67916860
[2] https://kosmetyczni.pl/uploads/dokumenty/Wprowadzanie_do_obrotu_2019.pdf
[3] https://sip.lex.pl/akty-prawne/dzienniki-UE/dyrektywa-87-357-ewg-w-sprawie-zblizenia-ustawodawstw-panstw-czlonkowskich-67428129
[4] https://ekos.gda.pl/pl/artykuly/cpnp-portal-zglaszania-produktow-kosmetycznych.html
[5] https://www.kosmopedia.org/regulacje/testy-na-zwierzetach/
