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Sunscreen products and claims EU Regulatory Framework Guidelines
Sunscreen products refer to Any preparation intended to come into contact with human skin Such as cream oil Gel Aerosol ,Its main purpose is to absorb Scattering or reflecting radiation to protect the skin from ultraviolet radiation European Commission ,2006 year ,Sunscreen products fall within the regulatory scope of the EU cosmetics regulations.Due to the specific protective purpose of sunscreen products,The EU has established some additional requirements Especially regarding its efficacy Claims and testing methods.
● Efficacy and testing methods
ultraviolet rays (UV) There are two types UVA and UVB.UVAradiation The spectrum is 320-400 nm Can penetrate deep into the skin,Therefore, it may lead to premature skin aging and skin cancer Melanoma ,andUVB radiation The spectrum is 290-320 nm Can only reach the surface of the skin,It's due to sunburn and redness.
To protect the skin from UV radiation,Sunscreen products must contain sunscreen agents.The EU allows the use of sunscreen listed in EU Cosmetics Regulations enclosure VIin,Not in attachment VISunscreen agents in the EU market must not be added to sunscreen products sold in the EU market.
Sunscreen products cannot filter all ultraviolet rays,But it must be able to protect UVA and UVB.According to the European Commission 2006 year 9 month 22 Suggestions and related statements on the efficacy of sunscreen products in Japan,The minimum effective level of protection for sunscreen products is
1. Sunscreen factor (SPF) by 6,Can resist UVB
2. UVAThe protection factor is the sun protection factor1/3
3. The critical wavelength is370nm.
Products that do not meet the above standards cannot be sold as sunscreen products.
2006 year 7 month 12 day,The European Commission authorizes the European Committee for Standardization (CEN) Develop European standards for testing the efficacy of sunscreen products.therefore,The following standards have been released
EN ISO 24442:2011 – Sunscreen testing method – sunscreen cream UVA Internal measurement of protection
EN ISO 2443:2021 External sunscreenUVADetermination of Light Protection Effect
EN ISO 24444:2020 – Sunscreen testing method – In vivo measurement of sun protection index (SPF).
● Declaration and labeling
The above-mentioned European Commission recommendation also specifies requirements for claims and labeling.declare Should be simple to make clear make sense,And based on standardization Repeatable standards European Commission ,2006 year ,Prohibit the use of the following and similar claims Sunscreen sun blocker Comprehensive protection total protection Prevention throughout the day all day prevention ,Because they imply that the product can resist all ultraviolet radiation,No need to reapply,But the fact is not so.
2005 year 4 month,The European Cosmetics Association has released a guideline,Identify what tests manufacturers must conduct to determine the waterproofness of sunscreen products.If the evaluation result is positive,Cosmetics can be applied waterproof water resistant or Super waterproof very water resistant Tags for.
It is particularly important to emphasize that,Some warnings and usage instructions are necessary
1. Excessive exposure to sunlight can pose a serious threat to health
2. Babies and young children must avoid direct sunlight exposure
3. Must be repeatedly applied frequently.
Manufacturers can change the warning wording themselves,As long as the meaning remains unchanged.in addition,It must be clearly stated how much product is needed to ensure sufficient UV protection The European Commission recommends that ordinary adults use 36 Ke product .
● Label requirements
As for labeling requirements,The efficacy of a certain sunscreen product must be classified according to the level of sun protection factor low in high or Very high And the category must be indicated on the pattern,Font and SPF identical.In order to help consumers better understand,Suggestions not only indicate SPF,Also indicate that it is correct UVA Protection level.through the use of Colipa Suggested UVA identification Within the circle UVA letter To achieve.
● reference
1.Cosmetics Europe (2009). 23 Important usage and labelling instructions for sun protection products. Retrieved on 28/06/2021 from https://www.cosmeticseurope.eu/files/9814/6408/4022/CR-23-Sunscreens_Labelling.pdf
2.EC (2006). Commission Recommendation of 22 September 2006 on the efficacy of sunscreen products and the claims made relating thereto. Retrieved on 28/06/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32006H0647&from=EN
3.EC (2006). Standardisation mandate assigned to CEN concerning methods for testing efficacy of sunscreen products. Retrieved on 28/06/2021 from https://ec.europa.eu/growth/sectors/cosmetics/products/sunscreen_en
4.Cosmetics Europe (2005). Guidelines for evaluating sun product water resistance. Retrieved on 28/06/2021 from https://www.cosmeticseurope.eu/files/7914/6407/7400/Guidelines_for_Evaluating_Sun_Product_Water_Resistance_-_2005.pdf
● The services provided by ZOOP
1. Product classification
2. CPNP Notification
3. Formula review
4. Label and claim review
5. Website detail page review
6. Cosmetic Safety Assessment Report(CPSR)
7. PIFDocument review and organization
8. Agency services for responsible persons within the European Union