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How to Ensure Cosmetic Compliance in Slovenia – Guidelines from Agency for Medicinal Products and Medical Devices

Medical Device Registration in Slovenia Medical devices intended for placement on the Slovenian market must comply with Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR). These regulations establish the requirements for safety, performance, and market access for medical devices within the European Union. Competent Authority...

Minimum legal requirements to sell cosmetics

Starting a cosmetic business in the European Union is an exciting opportunity—but it also comes with clear legal responsibilities. Whether you are developing your first formulation or planning to launch a brand, understanding the regulatory framework is essential from day one. In the EU, cosmetic products are governed by Regulation (EC) No 1223/2009, which ensures...

What is considered a cosmetic product under EU law?

Understanding whether a product qualifies as a cosmetic is a fundamental step for anyone entering the European market. This classification determines which legal framework applies and what  obligations must be fulfilled before placing a product on the market. In the European Union, cosmetic products are defined under Regulation (EC) No 1223/2009, which provides a clear...

EU Regulations for Sunscreen Products

Sunscreen products in Europe are treated as cosmetic products, so they must follow Regulation (EC) No. 1223/2009 on cosmetic products. This regulation sets the rules for safety, ingredients, labeling, and marketing before a product can be sold in the European Union. The European Commission has also issued recommendations on sunscreen efficacy and claims that manufacturers...

How to Ensure Cosmetic Compliance in Portugal – Guidelines from National Authority of Medicines and Health Products

Cosmetic compliance in Portugal is a fundamental requirement for brands that intend to manufacture, import, or distribute cosmetic products within the Portuguese market. Portugal is a Member State of the European Union and follows the EU Cosmetic Regulation (EC) No 1223/2009. It also enforces national controls through its designated competent authority. Companies must comply with...