The Virtual 6^th ERPA  Annual Congress on

Regulations and Compliance for Cosmetics

• What are the main projects related to cosmetics regulatory field the European Commission is focusing on at the moment?
• What other topics are expected in the near future?

This presentation will give a brief overview of the forthcoming targeted revision of the EU’s legislation on cosmetic products. This revision might include the prohibition of endocrine disrupting substances, the implementation of the ‘one substance, one assessment’-principle, a new definition of nanomaterials and digital labelling.

• Banned ingredients, restricted ingredients, published Omnibus Acts, CBD, endocrine disruptors
• Deadlines & implications

The endocrine system comprises a complex array of signaling mechanisms. Disruption is linked to adverse health effects. However, feedback loop mechanisms and adaptive responses regulate the secretion of hormones and maintain homeostasis. A chemical interfering with the endocrine system, named an endocrine disrupter (ED), may affect hormone secretion or other cellular factors, but such perturbations could remain as well within the homeostatic or metabolic detoxification capacity and therefore not result in adverse effects in the intact organism. In the EU, EDs are banned based on hazard, affecting cosmetic ingredients availability, as risk assessment must be animal-free. Indeed, the ED definition, according to WHO/IPCS, 2002 and the 5 stages defined by OECD TG 150 need to be followed. Consequently, an ED cannot be defined for cosmetic ingredients since only levels 1 and 2 are animal-free. Legislations concerned will be updated in the near future, but the question remains whether the use of harmless concentrations of cosmetic ingredients with ED properties, will still be allowed. The Scientific Committee on Consumer Safety (SCCS) actually performs risk assessment of 28 prioritized cosmetic compounds with ED activity. The future of these and other crucial cosmetic ingredients remains, however, very insecure.

• What are the implications on cosmetics?
• What is the process?
• When should we expect changes?

• Overview of national labelling requirements

• How to classify your products and choose the “right” legislation
• Medical Device Regulation2017/745 Annex XVI – List of groups of products without an intended medical purpose
• New classification rule for substances
• What to do when more legislation apply?

• When can you make such claims?
• What documentation you need?
• Who can help you?
• What is the process?

• Are they in vogue?
• What is skin microbiome?
• Under which circumstances you can make such claims?

When studying an anatomical structure, trying to understand its physiology, pathology, adaptation to change, and ageing, it is essential to know its histories. Indeed, each anatomical structure has two different histories, the developmental one and the evolutionary one; they are deeply linked together. Human skin has striking characters that, among many others, distinguish our species from other mammals. A deep understanding of human skin is conveyed by the knowledge of its evolution.

We find remarkable morphological and physiological differences even comparing it with that of other primates. The skin barrier, the hair, the eccrine glands, the microbiome, are only some of the features that strongly difference human skin from other primates’ skin, and obviously from other mammalian species. Moreover, the awareness of the differences, also within mammals, remarks that all the data yielded from studies on other animals need to be carefully applied to human. On the other hand, recent in vitro models, that are built from human cells and tissues, have a higher probability to give reliable response to any kind of test. The improvement of in vitro models is the promising way to further future, reliable, and personalized, testing methods.

• What is being developed at the moment?
• Status of the new Generation SAR

• Risk perceptions for cosmetics use during pregnancy among women and healthcare providers
• Are there pregnancy “safe” and “unsafe” cosmetics?
• Where can we find information on the topic?