Cosmetic Regulatory Requirements in Luxembourg complies with the EU regulation (Regulation (EC) No 1223/2009) without additional national requirements specific to cosmetics. The regulation sets out stringent requirements to ensure the safety of cosmetic products before they are placed on the market.
Ministry of Health (Ministère de la Santé)
The regulatory authority overseeing cosmetic products in Luxembourg is the Ministry of Health (Ministère de la Santé). They are responsible for enforcing the EU regulations and ensuring that cosmetic products marketed in Luxembourg comply with safety standards.
Language Requirements
Luxembourg has three official languages: Luxembourgish, French, and German. The label must be in one or more of the official languages of Luxembourg. It is common practice to have labels in French or German, as these are widely understood across the country.
Adverse Event Reporting
Adverse event reporting for cosmetics in Spain aligns with EU regulations, emphasizing the importance of promptly reporting serious incidents to the competent authority. Manufacturers and distributors must ensure compliance with these requirements to maintain product safety and regulatory compliance in the Spanish market.
Product Safety Assessment
Cosmetic products must undergo a safety assessment conducted by a qualified person before they can be placed on the market. This assessment ensures that the product is safe for human health when used under normal or reasonably foreseeable conditions of use.
Key Provisions of the Cosmetic Regulatory Requirements in Luxembourg
The Regulation (EC) No 1223/2009 on cosmetic products, which came into effect on July 11, 2013, replaced the Cosmetics Directive 76/768/EEC. The main objectives of this regulation are to ensure the safety of cosmetic products and to streamline the requirements across the EU member states.
Key elements of this Regulation
Safety Assessment
Before a cosmetic product can be placed on the market, it must undergo a safety assessment conducted by a qualified safety assessor. The safety report is part of the Product Information File (PIF).
Product Information File (PIF)
Every cosmetic product must have a Product Information File, which includes detailed information about the product, such as the safety assessment, product description, manufacturing method, proof of the effects claimed, and data on any animal testing performed.
Notification
Cosmetic products must be notified to the EU Cosmetic Products Notification Portal (CPNP) before being marketed. This centralized database is accessible to competent authorities for market surveillance and emergency purposes.
Labelling
The product label must include the name and address of the responsible person, the country of origin for imported products, the nominal content, the date of minimum durability, precautions for use, the batch number, the product’s function, and a list of ingredients.
Cosmetic Good Manufacturing Practices (GMP)
Compliance with Good Manufacturing Practices, as outlined in ISO 22716, is mandatory to ensure the quality and safety of cosmetic products.
Nanomaterials
Special provisions apply to nanomaterials used in cosmetics, including specific labelling requirements and notification to the European Commission.
Conclusion
Luxembourg’s regulatory framework for cosmetics aligns closely with EU standards, particularly Regulation (EC) No 1223/2009. The Ministry of Health plays a crucial role in overseeing compliance and ensuring that cosmetic products placed on the market are safe for consumers.
