Nolla And The Regulatory Framework of Cosmetics in Europe

19.08.2014

Nolla Antimicrobial has developed a regulation-compliant Nolla™ grade for cosmetics. It will revolutionize the way silver is used in the industry.

New regulations

The new EU Cosmetics Regulation 1223/2009 came into full force in July 2013. It replaced the Cosmetics Directive 76/768/EC that was adapted in 1976.

Revision of the cosmetic regulation enhanced safety requirements and market supervision, and introduced new rules for the use of nanomaterials in cosmetics. Nolla™ technology is not a nanotechnology and therefore the new rules relating to nanomaterials do not apply to Nolla Antimicrobial.

What is a cosmetic product?

There is a clear definition of a cosmetic product cited in the new regulations. It is defined as “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 exclusively or mainly to cleaning them, perfuming them, changing their appearance, protect­ ing them, keeping them in good condition or correcting body odours”.

Borderline issues

Even though a cosmetic product is well-defined, it may sometimes be unclear whether a product is a cosmetic within the cosmetics regulation or whether it is regulated under other legislation. Common borderline cases are between biocides and medicinal products.

The primary function of a cosmetic product is to clean, perfume, correct body odor, change the appearance, protect or keep in good condition. Primarily, a cosmetic product can not be used to treat, disinfect, eliminate or cure. However, a cosmetic product may have secondary functions inherent to formulation, such as antimicrobial property, which is thought as a preventative benefit.

There is not an all-inclusive guidance for borderline cases and therefore some borderline products need to be interpreted case by case. In addition, there are differences between European countries in classification of borderline products. Nolla Antimicrobial is working closely with authorities and consultants to guarantee its products are correctly categorized.

Silver in cosmetics

Various silver substances are used in cosmetics ranging from deodorants to creams in cosmetics in Europe.

Silver substances currently approved for use in Europe include silver oxide, silver chloride, metallic silver, silver citrate and silver nitrate. Functions of these silver containing substances vary from deodorizing and antimicrobial to preservative and skin conditioning.

Silver oxide is the silver source in cosmetic grade Nolla™ in Europe. Other silver substances such as metallic silver and silver chloride can be used when regulations allow it outside Europe. All approved cosmetic ingredients in Europe can be found on the database maintained by the European Commission.

Contact us

Nolla Antimicrobial takes regulations and consumer safety seriously. For more information about regulatory issues and how they apply to Nolla technology, please contact Nolla Antimicrobial.