What Does Constitute a Cosmetic Product?

A cosmetic product is any substance or mixture intended to be in contact with the external parts of human body or with the teeth and oral mucous membranes, solely or primarily for the purpose of cleansing, perfuming, altering their appearance and/or protecting and maintaining them in a good condition.

Cosmetic Products Production

The cosmetic products production is regulated by the Law on Items of General Use (Official Gazette, Nos. 39/13, 47/14) and the Ordinance on special conditions for the production and marketing of items intended for general use (Official Gazette, No. 80/18). The production area must be in compliance with the prescribed special technical and sanitary conditions. The cosmetic products manufacturer must also meet the requirements of the Croatian Standard on Guidelines for Good Manufacturing Practice in the field of cosmetics, HRN EN ISO 22716:2007. The ISO 22716:2007 Standard is an international standard that prescribes guidelines for the production, management, control, storage and distribution of cosmetic products. Cosmetic production must comply with the principles of Good Manufacturing Practice (GMP). We provide a service for the development of Good Manufacturing Practices for cosmetics with supporting documentation (operating procedures, forms) in accordance with the applicable Standard, adjusted to your facility’s characteristics, equipment development and production capacity.

Cosmetic Products Classification

Not every product used in everyday life that can be considered a cosmetic product, is classified as a cosmetic product in the EU. Also, not every product classified as a cosmetic product in the US, for example, is classified as a cosmetic product in the EU. Furthermore, cosmetic products can border with medical products, traditional herbal remedies, medicines and biocidal formulations. We can help you determine whether or not your product is a cosmetic product and devise a strategy for its development.

Cosmetic Products Categorization

Each cosmetic product is included to one of the cosmetic categories and sub-categories depending on its purpose and effect. Consequently, the category of cleaning products includes firm and liquid soaps, cleansing masks, cleansing lotions, peeling preparations, deodorants, etc., while the care category includes various lotions, gels and creams. Other categories are protection products, beauty products and perfumes. We help you determine the exact category of your cosmetic product.

Cosmetics Laboratory Tests

Challenge Test i.e. Preservative Efficacy Test, for example, is one of many laboratory tests and forms part of documentation containing product information – Product Information File (PIF) and reports on cosmetic product safety – Cosmetic Product Safety Report, CPSR). Challenge test is required for most cosmetic products except for those with low microbiological risk.

Stability and compatibility tests show the relative level of product stability in various conditions (storage, transport, shelf life) to which it can be subjected from the time of production to the expiry date, as well as the compatibility of the product with packaging. Stability and compatibility tests serve as the basis for determining the cosmetic product’s expiry date. We can help you determine which lab tests your cosmetic product needs to be subjected to.

Documentation Containing Product Information – Product Information File (PIF)

Before placing a product on the market, a Product Information File needs to be made. Product Information File represents product’s identity card. The central and most important part of the documentation is the report on the product safety – Cosmetic Product Safety Report (CPSR) which contains product formulation, raw material and packaging specifications, and laboratory test results. We will advise you on the selection of documents that must be included in the PIF and its development. Assessment of safety – Cosmetic Product Safety Assessment) is the ultimate result and vital part of the Report. The safety can be assessed exclusively by qualified professionals who, based on the information available in the Report and calculation results, determine whether the product is safe for consumers’ health and whether or not it complies with EU cosmetic regulations. We provide a service of Cosmetics Product Information Documentation development, in accordance with Regulation (EC) No. 1223/2009 requirements.

Cosmetic Products Labelling and Statements

Special rules apply to the cosmetic products labelling in the EU. Labels must contain certain information, while others are forbidden. Statements on cosmetic products that serve to inform end users about the characteristics and quality of products are also an important aspect of labelling. Regulation (EU) 655/2013, laying down common criteria for the justification of claims used in relation to cosmetic products, defines six criteria that guarantee a high level of protection for end users, in particular from misleading claims in relation to cosmetic products: Legal compliance, Truthfulness, Evidential support, Honesty, Fairness, Informed decision-making. We provide guidance on labelling requirements, verify the content of your labels and other promotional material, and work with you on aligning of all information on your labels with EU regulations.

Cosmetic Product Notification Portal (CPNP)

The final step before product launching is product notification the to the European Commission via the CPNP platform. The CPNP is an online notification system for submitting certain technical compliance related information about manufacturer and each of his cosmetic products placed on the EU market. Information submitted to the CPNP is then made available through the portal to the relevant Competent Authorities, enabling market surveillance, analysis and evaluation, as well as to safeguard against grey market or counterfeit products. The information is also available to Poison Control Centres and other similar bodies established in individual member states for medical treatment and consumer safety purposes. We provide you with assistance in every step of notification process of your products.