According to Regulation (EC) No 1223/2009,1 sunscreen products are classified as cosmetic products. In Part A of this article,2 different aspects of testing for the efficacy of sunscreen products and harmonisation were extensively explained. This article summarizes the regulation regarding claims and labelling wording for sunscreen in products in the EU.
Get automated Regulatory reports
Did you know that Prospector®'s Early Insights Toolkit offers access to up-to-date regulatory information and allows you to connect with experienced Regulatory Specialists? Discover how the Toolkit can make your job easier...
According to Commission Regulation (EU) No 655/2013, claims on cosmetic products shall conform to the following common criteria:
- Legal compliance
- Evidential support
- Informed decision-making
Since sunscreen products have significant effect on protection against UV exposure, the communication with consumers (labelling and claims) will be very important public health issues. Hence the EU commission did a public consultation and published a recommendation on sunscreen labels in 2006 (2006/647/EC).
This recommendation is based on four pillars:
- Claims that should not be made for sunscreen products
- Precautions to be available on the label
- Minimum efficacy standard for sunscreen products
- Simple labelling to assist consumer in choosing the right products
Based on this recommendation, the following claims are not allowed to be on sunscreen products:
- 100% protection from UV radiation (such as ‘sunblock’, ‘sunblocker’ or ‘total protection’);
- no need to re-apply the product under any circumstances (such as ‘all day prevention’).
The following wording should be displayed as precautions on the products:
- ‘Do not stay too long in the sun, even while using a sunscreen product’
- ‘Keep babies and young children out of direct sunlight’
- ‘Over-exposure to the sun is a serious health threat’
The following instructions are recommended to be displayed on labels:
- ‘Apply the sunscreen product before exposure’
- ‘Re-apply frequently to maintain protection, especially after perspiring, swimming or towelling’
Meanwhile it is important to emphasize the right quantity of sunscreen product required to achieve the claimed efficacy on the packaging. For example, include a warning such as: ‘reducing this quantity will lower the level of protection significantly’ is one of the EU commission recommendations to highlight the importance of applied quantity.
The commission aims to keep sunscreen labelling simple and easy to understand, so consumers can choose the right product. Hence, for communicating the efficacy of sunscreen, in addition of Sun Protection Factor (SPF), using one out of four categories (‘low’, ‘medium’, ‘high’ and ‘very high’) is recommended. The categories will provide a simpler indication of efficacy of sunscreen and should be labelled as prominently as the SPF number.
The four labelling categories compared to their relevant SPF numbers are:
|Labelled 'Category'||Labelled Sun Protection Factor (SPF)|
|Low Protection||6, 10|
|Medium Protection||15, 20, 25|
|High Protection||30, 50|
|Very High Protection||50+|
Furthermore, the EU commission concluded that for a product to make sunscreen claims, there should be a minimum degree of protection against UV radiation. So, products with lower than SPF 6 cannot be labelled as sunscreen products.3
In order to standardise the UVA claims, the claimed UVA protection factor should be 1/3 of the claimed SPF number and shall have a critical wavelength of 370 nm. Industry is now starting to introduce on-pack indication of compliance with EC recommendation with printing UVA in a simple circular shape. For the purpose of the labelling, the diameter of the logo should not exceed the height of the SPF number3. Furthermore, all the sunscreen products, which are marketed for beach and seaside locations, should have both UVA and UVB protection.
In conclusion, it is crucial to inform consumers about the safety risk of excessive sun exposure. At the end it is necessary to emphasis that EU commission document is a recommendation and not a regulation. However, following the EU recommendation and the guideline is very important to ensure the safety and better communication with consumers on sunscreen products.
- Regulation (EC) No 1223/2009
- EU SPF Regulations: A Historical Review of Sunscreen Product Testing
- IMPORTANT USAGE AND LABELLING INSTRUCTIONS FOR SUN PROTECTION PRODUCTS, COLIPA RECOMMENDATION N°23, Approved by PCPM 24 February 2009 [PDF]
- Commission Recommendation(notified under document number C(2006) 4089), (2006/647/EC), 22 September 2006
- Guidelines to Commission Regulation (EU) No 655/2013 laying down common criteria for the justification of claims used in relation to cosmetic products, July 2013. [PDF]
The views, opinions and technical analyses presented here are those of the author, and are not necessarily those of UL, ULProspector.com or Knowledge.ULProspector.com. While the editors of this site make every effort to verify the accuracy of its content, we assume no responsibility for errors made by the author, editorial staff or any other contributor. All content is subject to copyright and may not be reproduced without prior authorization from Prospector.