Which regulatory requirements do really matter?
Cosmetic products are used by consumers on a daily basis. Often they are applied to the human skin directly and many products such as face creams and beauty products remain on the skin for hours (leave-on products). In the European Economic Area (EEA) cosmetic products and associated efficiency claims are regulated by two major regulations: Regulation (EC) No 1223/2009 (cosmetic products) and Regulation (EU) No 655/2013 (criteria for the justification of cosmetic product claims). In addition, the ingredients used in the product formulation and the packaging are subject to other regulations such as Regulation (EC) 1907/2006 (REACH), Regulation (EU) 2019/1021 (POP) and Directive 94/62/EC (Packaging and Packaging Waste).
Not only the safety of the consumer has to be taken into account before placing a cosmetic product on the market. Especially, rinse-off products such as shower gels get washed into the sewage system bearing a potential hazard for the environment. Therefore, a toxicological and eco toxicological safety assessment of the ingredients used is crucial in order to protect aquatic and terrestrial species.
Obtaining an Ecolabel (e.g. Blue Angel, EU Ecolabel, Nordic Swan) can be an effective tool in order to demonstrate to consumers that a cosmetic product is environmentally-friendly.
It is important to note that products which fall under the jurisdiction of cosmetics regulations in the EEA may not be deemed cosmetic products in other countries around the world. The criteria defining a cosmetic product differ based on the functionality and efficacy claim used as well as the product composition. A regulatory compliance check including the determination of the product type and the relevant legislation should always be the first step before exporting (or importing) any products.
Knowing your regulatory environment is essential to stay in the market: with a global network of affiliates, knoell keeps track of the developments concerning global regulations. Read more about our strategic and regulatory consulting solutions.
For your cosmetic products we support you with...
- Information on regulatory requirements in target countries
- Check of compliance for formulations, labels, claims etc.
- Check of compliance for cosmetic packaging
- Regulatory advice on borderline product cases
- Regulatory status check for cosmetic ingredients (inventory check)
- Communication with authorities and actors of the supply chain
- Coordination of notification and registration processes for cosmetic products and ingredients
- Dossier preparation, e.g. INCI application
- Ecolabel support
- Post-submission support
Read more about our submission support services.
With a team of about 40 toxicologist, more than 70 environmental fate and modelling experts as well as approx. 45 ecotoxicologists your assessments are in competent hands.
- Toxicological and ecotoxicological evaluation of substances; Endocrine Disruptors (EDs)
- Development of exposure scenarios
- Risk and exposure assessments using conventional models (e.g. EUSES, Chesar, ECETOC TRA) and computer based (in silico) methods (e.g. QSAR, read-across)
- Review of notification documents, e.g. Product Information Files (PIF), Cosmetic Product Safety Reports (CPSR), INCI applications
- Data gap analysis
- Literature search and evaluation
- Risk and exposure assessments
- Environmental impact screening
- (extended) Safety Data Sheet preparation for cosmetic ingredients
Read more about technical and scientific support.
Study management and monitoring can be challenging tasks. Besides the various problems caused by complicated test substances, the right laboratory needs to be identified for the required study, and ideally you want a study to be performed in a way that it can be used for submissions in more than one country or region if your business is international. Find out why knoell might be the right choice for you when it comes to study management and monitoring.
Benefit from our up-to-date expert training modules, seminars and workshops held on scheduled dates at our training premises, online or at a location of your choice and individually designed for you. Explore our knoell academy programme!