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.
Company Outing to Celebrate the 80th Anniversary of the FRIKE GROUP at Europa-Park!
With beautiful weather and great spirits, we had the perfect opportunity to strengthen our team spirit and create many unforgettable memories. 🤗🎉 The delicious lunch buffet was an additional highlight, and the energy boost was gladly welcomed. 💪🎉
A huge thank you to the entire team for the amazing atmosphere and to everyone who made this day so special! 💪 Together, we look back on 80 years of FRIKE and look forward to many more successful years to come.
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
Visit us at the CPHI in Milan, October 8-10, 2024
One of the largest pharmaceutical trade fairs in Europe is about to begin again, and as always, we will be there with our booth.
Visit us in Hall 7, Booth No. 7D74, and let's talk about future projects.
We look forward to hearing from you.
Your FRIKE Pharma Team
Scale-up to a new level
Whereas it was previously possible for air inclusions or insufficient homogenisation to impair the tests, the new Mini offers the full range of possibilities of a production mixer. This means that reliable data is already at a new level during development for later scale-up.
This puts FRIKE in a position to support new development projects even more competently, as the new Mini is a mixer of the latest generation. It has a high-shear homogeniser with a circuit that reflects all the dosing applications of a large-scale plant. In addition, the mixer has a memory that continuously logs the parameters travelled. This enables exact comparisons of the tests carried out.
Ultimately, the fact that the new Becolab Mini is the first qualified system of its kind at FRIKE is a decisive factor for us. It can be used to prepare small quantities under GMP production conditions, which can be used in clinical trials, for example. It has already passed its baptism of fire with the first test batches, and the first projects under GMP conditions are under discussion.
We asked our customers for feedback at the beginning of 2024. The result was that with a few exceptions, customers are very satisfied with FRIKE. Particularly appreciated were "friendliness", "clarity of quotations" and "quality of delivery" were rated the highest.
On contrary, the points "is FRIKE innovative" and "Value for money" were rated the lowest! We take this feedback very seriously and endeavour to improve the less rated points.
All in all, however, we can all be extremely proud of ourselves, because the survey only went so well because we are a company with very competent and motivated employees.
As FRIKE donated CHF 30 per completed questionnaire to the Sternschnuppe Foundation, we were able to fulfil a heartfelt wish with the money raised.
The specific beneficiary was a boy called Emilio, who suffers from a heart defect. A few weeks ago, he was allowed to visit the Rega base in Dübendorf and take a sightseeing flight in a helicopter (not from Rega). We are delighted that we were able to fulfil Emilio's heartfelt wish and would like to thank everyone who took part once again.
Modernisation of Cosmetics Regulation Act
The requirements for cosmetic products on the US market are now similar to EU cosmetics legislation:
- Registration of products and manufacturing facilities with the FDA (Product Listing, Facility Registration),
- Appointment of a person responsible to the authorities (Responsible Person),
- Preparation of a safety report for the products (safety substantiation),
- Production under GMP conditions,
- Recording and reporting of adverse effects (Adverse Event Reporting).
Whether there will be mutual recognition, e.g. for European product safety reports or GMP certification in accordance with ISO 22716, remains to be seen.
This does not affect the previous regulation that certain products (e.g. sun protection products) are categorised as OTC pharmaceuticals in the USA and therefore require a significantly higher regulatory effort.
The following FRIKE Group sites fulfil these high requirements: Glaropharm is FDA-Pharma certified, FRIKE Pharma AG in Mönchaltdorf is working on finalising certification as soon as possible.
All "normal" cosmetic products under MoCRA must be registered in the USA from 1 July 2024 and fulfil the above requirements. Registration of the associated production facility is also important for product registration. Our cosmetics plant FRIKE Cosmetic AG in Ebnat-Kappel has the necessary facility registration with the FEI number (FDA Establishment Identifier).
For representation in the USA, the FRIKE Group works with Michael Pfeiffer (Pfeiffer Consulting) and Claire Bing (Confiance Cosmetic). We will be happy to put you in touch with them.
The FRIKE Group is the right partner if you want to distribute cosmetic products in the USA.
Improved usability and simple orientation
Our website has been completely redesigned to make navigation more intuitive. Future customers will benefit from the new structure, which clearly divides our business areas into three divisions: Pharmaceuticals, Cosmetics and Chemicals. This organization makes it easy to find exactly the information you are looking for without having to click through different company pages.
Hot-air balloon competition
Around 30 competition teams from all over the world have travelled to this high-calibre competition, including numerous world, European and national champions. The hot-air balloon competition is about which pilot can fly their balloon with the greatest precision. The competition regulations define 20 different types of task. The competition director usually sets several tasks per flight, which are adapted to the respective weather situation. Swiss pilot Stefan Zeberli and his team won twice.
The day was a unique experience and the winners were able to take marvellous pictures.
What is the role of the person with technical responsibility?
«Medicines are regulated by the authorities, so they are subject to high quality requirements and must be safe for patients. The person with technical responsibility has a bridging function between the regulatory requirements in the manufacture of medicinal products and the internal implementation of these regulations. This ensures that regulatory requirements are also applied in the company and that all products meet the high quality requirements. In this context, the person with technical responsibility also acts as an interface between the authorities and the company.»
Why did you choose the FRIKE GROUP as your new employer?
«With around 300 employees, the FRIKE GROUP is one of the largest contract manufacturers in Switzerland. I appreciate being part of the set-up of a large manufacturer with a broad product range and lots of interesting products, as it means exciting projects and challenging tasks. At the same time, I like the informal working environment of FRIKE PHARMA AG, as a small company. Thanks to the manageable size of the company, my tasks are very varied and range from team management to the implementation of the GMP guidelines and the release of medicinal products as the person with technical responsibility. That won me over, and I’m looking forward to taking on many new challenges.»