Head of Unit, European Commission, DG for Internal Market, Industry, Entrepreneurship and SMEs
- 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.
Regulatory Affairs Consultant, Obelis Group, Belgium
- Banned ingredients, restricted ingredients, published Omnibus Acts, CBD, endocrine disruptors
- Deadlines & implications
Prof. Dr. Emeritus, In Vitro Toxicology and Dermato-Cosmetology (IVTD) at Universiteit Brussels, Belgium
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.
Director Technical Regulatory & International Affairs, Cosmetics Europe, Belgium
- What are the implications on cosmetics?
- What is the process?
- When should we expect changes?
- Overview of national labelling requirements
President, Medical Device Safety Service, Germany
- 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?
Director at The International Natural and Organic Cosmetics Association - NATRUE, Belgium
• When can you make such claims?
• What documentation you need?
• Who can help you?
• What is the process?
Vice President Science & Consulting, proderm, Germany
• Are they in vogue?
• What is skin microbiome?
• Under which circumstances you can make such claims?
University of Genoa, DISTAV, Italy
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.
CEO, Angel Consulting, Italy
• What is being developed at the moment?
• Status of the new Generation SAR
Co-Founder, Labfit, Portugal
- 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?
Head of Service, Medical Devices Department, Agencia Española de Medicamentos y Productos Sanitarios, Spain
CEO, Trianon Scientific Communication, Chairman Business Operation, Obelis
• What is a green and more sustainable innovation in nanotechnology?
• What are the new trends in green & more sustainable innovation for cosmetics?
• Why are they a driving force for the future of the cosmetic industry
This presentation will give a short overview of green sustainable innovation of smart
nanoparticles in the sector and why they will enhance a green beauty sector as they meet
the sustainable development goals raised by the UN.
Consultant Regulatory Affairs for Cosmetics, MDSS, Germany
- Legal responsibilities of different economic operators
- Principles of Post Market Surveillance and preparation for In-Market Controls
- Communication between economic operators and competent authorities
- RAPEX system and Business Alert Gateway
Cosmetics’ and Evaluations’ Departments at National Organization for Medicines (EOF), PRAC Member at EMA, PEMSAC Responsible Person Representing Greece
Pharmacovigilance is defined by WHO as “the science and activities related to the detection, assessment, understanding and prevention of adverse drug effects or any other possible drug-related problems. In line with this general definition, underlying objectives of pharmacovigilance in accordance with the applicable EU legislation for are: a) preventing harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of marketing authorization or from occupational exposure; and b) promoting the safe and effective use of medicinal products, in particular through providing timely information about the safety of medicinal products to patients, healthcare professionals and the public. Pharmacovigilance is therefore an activity contributing to the protection of patients’ and public health. Cosmetovigilance is a form of health surveillance i.e., public surveillance with a public health objective and its scope is cosmetic products. Are there similarities and differences between these two disciplines? What is a SUE, and can it be compared with a serious adverse reaction (ADR)? Is there room for future improvement concerning cosmetovigilance and can certain risk minimization measures, used in pharmacovigilance, be inserted in the field of cosmetic products?
Regulatory Affairs Manager, COSMED, France
• What are the Omnibus Acts?
• What is the process behind and who is involved?
• How is it impacting you and what are the main challenges?
Technical Director, National Perfumery and Cosmetics Association (Stanpa), Spain
Technical Advisor, National Perfumery and Cosmetics Association (Stanpa), Spain
Associate Professor, University of Genoa, Italy
Aluminium is an ubiquitous element found both in nature and in human-made products. Aluminium may trigger several adverse effects thus compromising the health of exposed organisms. In fact, Aluminium exposure can result in several toxic effects ranging from interference with metabolism of other cations, such as Calcium and Iron, to severe neurotoxicity. In cosmetics, Aluminium is widely used in antiperspirants, lipsticks and toothpastes. In the light of recent data, the SCCS considers that the use of Aluminium compounds is safe at the following equivalent concentrations up to: 6.25% in non-spray deodorants or antiperspirants; 10.60% in spray deodorants and antiperspirants ; 2.65% in toothpastes and 0.77 % in lipsticks. No data are available on Aluminum leach, eventually ingested with toothpaste. In this study, the bioavailability of Aluminum included in cosmetic products used for oral care was assessed, and preliminary data are here presented.
CEO, Angel Consulting, Italy
- General overview of regulatory status for cosmetics for pets
- How can you demonstrate the safety of your cosmetics for pets?
Scientific Affairs Manager, CTPA, UK
This session gives an overview of the requirements for cosmetic products sold in Great Britain, as the UK Cosmetics Regulation entered into force on 1 January 2021. The session focusses on some challenges that companies face when trading cosmetics between the UK and the EU, in particular looking at the status of ingredients management processes and the possibility of divergence in the future.
Head of International Growth and Regulatory Services, CTPA, UK
This session outlines the best practices of claims and their substantiation, developed by CTPA and relevant stakeholders in advertising in the UK. CTPA will also give an overview of the UK advertising landscape and rules, as well as interpretation of borderline scenarios for cosmetic products.