At the beginning of 2024, several press reports highlighted the detection of the substance mono-n-hexyl phthalate (MnHexP) in urine samples from children and adults. These tests were conducted by the German Environment Agency (UBA) and the State Office for Nature, Environment, and Consumer Protection of North Rhine-Westphalia (LANUV) as part of a study.
The reason for these findings could be di-n-hexyl phthalate (DnHexP), a substance that was previously widely used as a plasticizer in plastics. However, this substance can also appear as a by-product in sunscreen products. The Chemical and Veterinary Investigations Office in Karlsruhe (CVUA) found concentrations of 0.3 to 16 ppm in various sunscreen products. The source appears to be the UV filter DHHB, which has been increasingly used in recent years to replace other UV filters that are now banned. DnHexP may be present as an unwanted by-product.
In its statement of March 21, 2024 (017/2024 "MnHexP in Urine Samples: Health Risk Assessment"), the Federal Institute for Risk Assessment (BfR) concluded that the concentrations found "pose no cause for concern" from a health perspective. It is essential that consumers are not unsettled by these findings and continue using sunscreen to protect themselves from harmful UV radiation.
How is FRIKE handling this issue?
FRIKE also uses the UV filter DHHB in sunscreen products. Since the by-product DnHexP is prohibited in cosmetics, even as an impurity, only unavoidable traces are allowed. This means that extra care must be taken during the production of the DHHB UV filter.
FRIKE's quality policy is to source only high-quality raw materials with minimal by-products. External analyses of customer products have shown that the sunscreens manufactured by us contain only extremely low levels of DnHexP – so low that they are nearly at the detection limit. Thanks to our high-quality standards, FRIKE was able to support customers contacted by authorities with reliable data in a monitoring campaign.
If you have any questions on this topic, please contact your FRIKE representative.
Visit us at the SEPAWA Congress, October 16-18, 2024, Estrel Congress hotel, Berlin
Soon, the most important gathering for the detergents, cleaning products, cosmetics, and perfumery industries will begin again, and as always, we will be there with our booth.
Visit us in Hall C, Booth No. 483 & 484, and let's discuss future projects.
We look forward to seeing you.
The FRIKE Cosmetic Team
What does this mean for us and our customers?
Certain substances have been shown to be a significant cause of allergic reactions in consumers who are sensitive to fragrances. To ensure that such consumers are adequately informed, the presence of these substances should be indicated on the list of ingredients.
The purpose of this additional labeling is to inform sensitive individuals who have been tested and know which ingredients to avoid.
Currently, 26 “fragrance allergens” must be included in the list of ingredients, even if they are components of a perfume, a flavoring or a complex ingredient. Labeling is mandatory if the substance is present in the cosmetic product above certain threshold concentrations, which are different for leave-on and rinse-off products. The new regulation extends this list to over 80 allergens.
FRIKE Internal is a specially created task force that is now working hard on this issue, as around 1,000 raw materials are affected and now need to be examined. Examples of affected raw materials include perfume oils, extracts, tinctures and essential oils. Affected customers will be informed of any changes and adjustments in good time.
Transition periods and deadlines are as per publication in the Official Journal of July 27, 2023.
The date of entry into force of the new regulation was August 16, 2023, but there is a transitional period until July 31, 2026 for placing on the market (production or import into the EU). The transitional period for making products available on the market (sale and withdrawal of products) runs until July 31, 2028. The detailed implementation and guidelines for the law are currently being discussed. The FRIKE GROUP is monitoring this and has simultaneously begun implementing the extended allergen list in the internal computer system.
What other effects will this have?
The extension of the list of allergens will lead to new challenges in regulation and implementation. Consumers with allergies will have to remember many new and complicated names for one and the same type of allergen. At the same time, there will be space problems on labels due to the very long list of ingredients.
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Contract filling of aerosols as foams, sprays and gels
We use bag-on-valve technology for contract filling in various areas of application. Compared to conventional aerosol technologies, bag-on-valve offers a longer shelf life, optimum spraying capabilities, complete emptying of the can, hygienic cleanliness thanks to separate areas for propellant gas and product, and the use of environmentally friendly gases.
• Filling quantities from 15 liters to 50 tons, and from small test markets and sample filling to fully automated large-scale production.
• Filling volumes: We fill cans made of aluminum, PCR aluminum, tinplate or, on request, glass with quantities of 10 ml to 1000 ml.
• We use various gases: Propane, butane, trimethyl ether, high-density substances, air, oxygen, nitrogen, nitrous oxide and carbon dioxide.
• Several fully automatic filling systems are available for filling aerosol cans as foams, sprays or gels at high speeds of up to 80 units per minute.
• Measurements are carried out by volume and by weight.
• Affixing data to the container: We can also label RFID chips on the line for storing data sheets, product information, etc. (competition to QR code)
• Various sealing methods: Cans can be sealed using various methods, including induction, heat or simply by pressing on sealing film.
• Automatic labeling in various shapes: rounded, on the front and back or all the way around.
Your Swiss contract manufacturer with expertise in cosmetics, pharmaceuticals and chemicals
The FRIKE GROUP is the largest independent contract manufacturer in Switzerland and produces private label products and branded products for national and international customers. As a full-service partner of expertise, our core competencies lie in the development of innovative and sustainable products, their manufacture and bulk production, filling, packaging and regulatory services.
From sourcing to shipping and everything in between: As a contract manufacturer, we offer you a complete service. Each of our five locations has its own development laboratory, so we can guarantee high Swiss-made productivity and comprehensive expertise. Customers in all our sectors – cosmetics, pharmaceuticals and chemicals – benefit from rapid technology transfer. Let’s work together to make your product ideas a reality.