MARIE MAGNAN
Regulatory Affairs Manager, COSMED, France

Abstract

Sunscreen products are among the most regulated cosmetic products. Indeed, helping consumers protect themselves from UV radiation, they can also, if poorly formulated or misused, lead to short-term (burns) or long-term health problems (skin cancers). 

In this article, Cosmed exposes first regulation in the European Union. Then, the main differences between the European Union and some international regulations will be discussed. The last part will develop the latest changes in regulation and the latest developments in testing.

INTRODUCTION

During the lockdown period in Europe, cosmetic products, and among them sunscreen products, recorded a huge drop in sales (-89%). However, until this year, market share for sunscreens, estimated at 9.1 billion euros worldwide, was growing by almost 4% per year (source Euromonitor).

REGULATORY FRAMEWORK FOR SUNSCREENS IN THE EU

Texts and definition

In the European Union, sunscreen products are defined as cosmetic products according to the Regulation (EC) No. 1223/2009 on cosmetic products and are therefore subject to all the requirements of this regulation, especially labelling and safety assessment.

In addition, on September 22, 2006, the European Commission published a recommendation concerning the efficacy and labelling of sunscreens “ Commission Recommendation on the efficacy of sunscreen products and the claims made relating thereto “. 

This text defines a sunscreen product as any preparation (such as creams, oils, gels, sprays) intended to be placed in conta ...