3. Case studies of frontier products
Frontier products reveal the challenges of regulatory classification due to their hybrid nature. These detailed case studies analyze concrete examples from various sectors, examining their specific characteristics: product type, substance type, area of application, expected and foreseeable use, presentation and claim. These analyses help us to understand how regulatory frameworks influence their positioning on the market.
3.1 Hydroalcoholic hand gels
At first glance, hydroalcoholic gels might seem to fall into the regulatory category of medical devices. The table at 12 enables us to analyze the criteria for a medical device and apply them to hydroalcoholic gels.
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Case studies of frontier products
Conclusion
Bibliography
Standards and norms
- Management de la sécurité des denrées alimentaires, 2e édition. - ISO 22000 - 2018
- Food safety management systems – Recommendations for the application of ISO 22000, 1re edition. - ISO 22004 - 2014
- Raw materials of natural origin – Vocabulary, 2nd edition. - ISO 9235 - 2013
- Bonnes pratiques de fabrication (BPF). - ISO 22716 - 2007
- Antiseptics and chemical disinfectants – Quantitative suspension...
Regulations
Public Health Code, sub-section 3: traditional herbal medicines (articles R. 5121-107-3 to R. 5121-107-15) (2025).
Article L. 5111-1 of the French Public Health Code.
Law of March 25, 1964 on medicines and its implementing decrees.
Regulation (EC) no. 1924/2006 on nutrition and health claims made on foods.
Regulation (EU) 2017/745...
Patents
EP1638582A1 – Use of hyaluronic acid for preparing compositions for treating oral cavity aphthas (2004).
CN106341977B – Improved mouthwash formulations (2015).
US7985432B2 – Insect repellent (2008).
WO2002036138A1 – A head lice formulation (2001).
Directory
Manufacturers – Suppliers – Distributors (non-exhaustive list)
Directory of cosmetics professionals:
http://www.cosmetic-valley.com/annuaire/
Directory of pharmaceutical companies :
...
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