Advice from BuRO Regarding the health risks of insufficient UV protection in sunscreen products
Work towards good in vitro methods that are prescribed as reference methods for measuring UV protection of sunscreen products. Make sure that a sunscreen application thickness is used that is representative of the consumer behavior. Pay attention to the stability of UV filters during the recommended period of use, and to protect against both UVA and UVB radiation. This advice is given to the State Secretary for Youth, Prevention and Sport.
Other advises
BuRO advises the State Secretary for Youth, Prevention and Sport to contribute to the revision of Recommendation 2006/647/EC. Ensure that a uniform SPF is produced that will serve as a realistic measurement for both UVA and UVB protection. Inform consumers about the meaning and the importance of UVA and UVB protection.
BuRO also gives the Inspector General of the NVWA the following advice:
- Inform the industry about the sometimes considerable discrepancy in results between the in vivo reference method and the double plate in vitro method.
- Enforce if the declared SPF values of sunscreen products are too low.
Background
In 2023, the NVWA conducted a study of the UV protection of sunscreen products on the Dutch market. The NVWA laboratory determined the SPF using an in vitro method, in which sunscreen products were applied to test plates in order to measure the transmission of UV radiation. A number of products have also been tested via the standardized in vivo method. It became clear that different test methods can lead to different results. The SPF was generally lower when measured with the new in vitro method.
To substantiate any measures, the Enforcement directorate posed the following question to the Office for Risk Assessment and Research (BuRO) of the NVWA:
“At what deviation from the SPF measured using in vitro methods as compared with the SPF claimed on the product does a (serious) health risk occur?”
To be able to answer this question, BuRO added the following questions:
- What are the risks to the consumer from the harmful effects of UV radiation based on the available product information regarding sunscreen products?
- How is the system of classification/categorisation of sunscreen products structured?
- What methods are available for determining the SPF, and what are their advantages and disadvantages?
Answers to the questions
At what deviation from the SPF measured using in vitro methods as compared with the SPF claimed on the product does a (serious) health risk occur?
An increased health risk occurs if the actual SPF is lower than the claimed SPF. No quantitative conclusion can be drawn due to the fact that SPF is based on UVB protection, whereas skin cancer can also be caused by UVA radiation. This makes it impossible to accurately quantify the actual protection that the sunscreen product offers against both UVA and UVB radiation.
If the SPF measured is lower than the SPF claimed on the packaging, the consumer is misled and this discrepancy contributes to an increased risk of developing skin cancer later in life.
What are the risks to the consumer from the harmful effects of UV radiation based on the available product information regarding sunscreen products?
This includes 2 questions.
How is the system of classification/categorisation of sunscreen products structured?
Sunscreen products are classified on the basis of the degree of UVB protection they offer (SPF). According to Recommendation 2006/647/EC, sunscreen products must also offer UVA protection, equivalent to at least one third of the UVB protection.
What methods are available for determining the SPF, and what are their advantages and disadvantages?
In vivo reference methods measure UVA and UVB protection based on observation of an acute effect in test subjects: the erythemal response to UVB radiation and the tanning of the skin by UVA radiation. It is unknown how this acute effect relates to the level of UV protection and protection against negative health effects in the long term, such as premature skin ageing and skin cancer. These in vivo methods are only tested on a single specific skin type.
In vitro methods are also available. The advantage of these methods is that the entire spectrum of UV radiation can be quantitatively measured. The step involving irradiation with a UV lamp also provides a quantitative measurement of the stability of UV filters during the period of use.
The disadvantage of these in vitro methods is that they do not take into account the interaction between the sunscreen product and the skin. In addition, the results obtained are corrected so that they correspond more accurately with the results obtained using the in vivo reference methods.
For both the in vivo and in vitro methods, the specified quantity of the product specified is not representative for the quantity that consumers actually apply to their skin.