Product Information File (PIF), Cosmetic Product Safety Report (CPSR), CPNP portal, Responsible Person cosmetic product classification, stability tests, Challenge test, IFRA, PAO...
If these words sound confusing to you, feel free to call us. We will help you to prepare this files according to the EU Cosmetic Products Regulation (EC) No. 1223/2009.
Preparation of documentation is a very complex process, for which time and money need to be allocated. It is necessary to prepare in time!
The MNS Centar was founded in 2020. with the goal of educating and providing consulting services to small producers about the cosmetic industry, production and legal regulations necessary for placing products on the market. From this idea developed the need to provide the service of preparation of PIF and Report on the Safety of Cosmetic Products (Safety Assessment). Our clients have successfully marketed their products in the EU, and we can also boast of cooperation with foreign clients from the EU territory for whom we did safety assessments. We offer comprehensive advice/service to cosmetic manufacturers and distributors in compliance with the regulatory requirements of the European Regulation.
When assessing the safety of a cosmetic product, we always start from the definition of the cosmetic product.
A "cosmetic product" shall mean any substance or mixture intended to be placed in contact with the various 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...
When placing a cosmetic product on the market, whether you are in the EU or in Serbia, you must have a Product Information File (PIF). A Cosmetic Product Information File is a document that contains all relevant information about the product itself. It is stored for a period of 10 years from the date when the last batch of the cosmetic product was placed on the market.
The label of the cosmetic product must be in accordance with the Regulation on cosmetic products. The declaration can be found on the primary and secondary packaging. If the product has both primary and secondary packaging, the declaration can be in a shorter form on the primary packaging.
In order to prepare a report on the safety of a cosmetic product, it is necessary to perform certain tests. What tests are needed to do a safety assessment is a very complex process. It is determined on a case by case basis.
Stability tests of cosmetic products are performed to ensure that the cosmetic product retains its intended physical, chemical and microbiological quality, as well as functionality and aesthetics when stored under appropriate conditions.
When marketing a cosmetic product on the territory of the EU or on the territory of England, there is an obligation of the manufacturer to register the product itself on the CPNP portal or The UK Cosmetic Products Notification Portal (SCPN).
After registration, you receive a confirmation that the product has been notified. Only after that you can start marketing the product on the EU market.
According to the Cosmetic Regulation, cosmetic products are classified into 26 types: Creams, emulsions, lotions, gels and oils for the skin; Face masks; Colored substrates (liquids, pastes, powders); Decorative ("Make-up") powders, after-bath powders, hygienic powders; Toilet soaps, deodorant soaps; Perfumes, toilet waters and colognes; Products for bathing and showering (salts, foams, oils, gels); Epilators; Deodorants and antiperspirants; Hair coloring products; Products for curling, straightening and fixing hair, Products for strengthening hair; Products for washing and cleaning hair (lotions, powders, shampoos); Conditioning products (lotions, creams, oils); Hair styling products (lotions, varnishes, brilliants) Shaving products (creams, foams, lotions); Make-up and make-up removal products; Products for use on the lips; Products for the care of teeth and oral cavity; Products for nail care and beautification; Products for external intimate hygiene; Sun protection products; Skin tanning products without sun exposure; Skin whitening products; Anti-wrinkle products; Other products in accordance with the definition of the term "cosmetic product".
Item 5 contains toilet soaps and deodorant soaps. As soaps are cosmetic products, it is necessary to assess the safety of the cosmetic product for them.
The challenge test is a test that shows how resistant your product is to external contamination. This applies to products that contain water in their composition and whose packaging is such that contamination can occur during the use of the cosmetic product itself. If you are not sure whether your product falls into one of these categories, contact us.
A PIF on a cosmetic product is a document that is taken care of, and can also be created by the person responsible for the cosmetic product. If you are unable to create it, we can do it for you.
The Safety Assessment report is an integral part of the PIF on the cosmetic product, i.e. separate document. It is made by a Cosmetic Product Safety Assessor. This is the person who evaluates the cosmetic product with his experience and competences and lists his qualifications at the end of the report. According to legal regulations, it can be a pharmacist, doctor, toxicologist with experience gained in additional education. The Safety Assessment of the cosmetic product at the MNS Center is performed by a graduate pharmacist, cosmetology specialist, international safety assessor who obtained his qualifications at the University of Vrije.
GMP (Good Manufacturing Practice) is a set of guidelines that you use in your daily work to ensure that each of your products is manufactured with the same quality, consistency and safety.
The GMP standard itself refers to the work of the staff, the organization and appearance of the premises, the marking and receipt of raw materials, and quality control of the finished product.
All companies that sell their cosmetic products must produce them according to this standard. According to the Cosmetic Regulation EU 1223/2009, you need to manufacture your product in accordance with this standard. This standard is also called ISO 22716. It is not an obligation to introduce and certify it, but you must work according to the requirements of GMP. The authorities can certainly require you to prove that you work according to these standards, so it is certainly desirable to have proof. When creating the PIF file, it is also necessary to make a statement that you work according to GMP standards.
You have an idea but you don't know how and where to realize it. We provide you with the service of formulating and designing products in accordance with modern trends. Based on many years of experience and continuous education, we will provide you with better insights into the world of cosmetics and an understanding of processes and legal regulations.
In cooperation with our partners, we can also organize service production for you in accordance with all applicable standards.
We also do all the necessary supporting documentation for your product.
Contact us for more detailed information.
The effectiveness of the cosmetic product is very important for consumers, but also for your marketing and labeling of the product itself.
The claims you make on the product declaration and later for the purpose of advertising and marketing campaigns of your cosmetics must be supported. According to the Regulation, the responsible person ensures that the text of the claim related to the cosmetic product is aligned with the documentation that proves the claim about the effect of the cosmetic product, which is an integral part of the PIF.
Challenge test is also known as Preservation Efficacy Test.
The challenge test is not the same as microbiological testing of the preparation.
The Challenge test checks how effective the cosmetic product's preservative system is and whether it is capable of withstanding various types of contamination during production, from the environment or during use of the product itself during its shelf life.
The responsible person is fully responsible for the safety of the cosmetic product, makes product information file (PIF) that he keeps for 10 years after placing the last batch of products on the market, registers the product on the CPNP portal, is responsible for labeling cosmetic products in accordance with legal regulations, communicates with legal authorities.
GMP (Good Manufacturing Practice) is a set of guidelines that you use in your daily work to ensure that each of your products is manufactured with the same quality, consistency and safety.
As of November 10, 2022., the European Commission adopted official amendments to the Regulation and amendments to Annexes III and VI of the EU Regulation on cosmetic products. Annex III is a list of substances that can be used in cosmetics only according to certain restrictions specified in it. Annex VI includes UV filters permitted for use in cosmetics.
On September 23, 2022, the Scientific Committee on Consumer Safety (SCCS) issued a final and official opinion on genistein and daisdein.
On September 15, 2022, the European Union notified the World Trade Organization (WTO) of the draft regulation on the labeling of allergens, fragrances in cosmetic products. The current list of allergens will be expanded to include 61 additional fragrance ingredients, essential oils or other components.
From December 17, 2022., the application of the Omnibus V Cosmetic Regulation begins. What does this regulation bring? According to this regulation, 14 ingredients are banned.
They will be added to the list of Annex II (Annex II of our rulebook) of the Cosmetic Regulation.
