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.
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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Trends and innovations
Lively hustle and bustle in the aisles, lively discussions, and exciting presentations: on 5 and 6 June 2024, numerous decision-makers from the cosmetics industry and their suppliers gathered at CosmeticBusiness 2024 at the MOC Munich to exchange ideas about trends, innovations and new projects. At the international supplier fair for the cosmetics industry, 418 exhibitors from 23 countries presented their latest products and solutions in the fields of ingredients, manufacturing and packaging. The extensive specialist programme in the INNOVATION CORNER with top-class speakers such as Alicia Lindner from BÖRLIND and Birgit Huber from IKW was very well received.
In the DACH region, Cosmetic Business is the most important trade fair for packaging materials and therefore also for contract manufacturers. More raw material suppliers are also exhibiting, but interest is rather low. Our stand in Hall 3 had a very good location and was literally overrun in places. According to Ronnie Heusser, Sales Manager at FRIKE Cosmetic, we had never made so many new contacts at a Cosmetic Business as we did this year.
And what else is there to report about the trade fair?
Sustainability remains the hot topic in the packaging sector. This year, exhibitors will primarily be showing how they are using mono-material solutions to further facilitate recycling and thus recyclability. The fact that recycled materials can be used more and more effectively in the form of PCR will also be demonstrated at the exhibition using various examples.
