Introduzione
Ensuring compliance with regulatory requirements for cosmetic products is a key factor in fostering the growth and success of a cosmetic brand while prioritizing consumer safety.
From selecting suppliers and ingredients to developing formulations, determining product positioning and claims, and managing sales and distribution, understanding the applicable regulatory framework is essential at every stage.
This course offers grounding knowledge of the regulatory requirements for placing cosmetic products on the EU market, along with the main differences and particularities of the US and Canadian markets.
Cosmetics in the EU
Overview of EU Cosmetics Regulatory Framework
- Regulation (EC) No. 1223/2009 on Cosmetic Products
- Cosmetic Regulatory Definition and Borderline Products
- Economic Operators along the Supply Chain
- Responsible Person: definition and obligations
Regulatory Requirements – From Concept to Market
- R&D of cosmetic formulations for placement in the EU market
- Good Manufacturing Practices (GMP)
- Product Information File (PIF): structure and contents
- Safety Assessment Report: structure, contents, and responsibilities of the EU Safety Assessor
- Labelling Requirements
- Advertising, Proof of Claims and Alleged Effects
- Cosmetic Product Notification Portal (CPNP)
- Post-Market Surveillance – Cosmetovigilance obligations
Q&A session
Main differences of the US and Canadian markets:
Overview of US Federal Cosmetics Regulatory Framework
- FDA’s authority over Cosmetics
- Cosmetic Regulatory Definition
MoCRA Overview
- New facility registration requirements
- Product listing requirements
- Serious adverse event reporting
- Safety substantiation documentation
- Good Manufacturing Practice regulations
Overview of Cosmetics Regulations in Canada
- Health Canada’s authority over Cosmetics
- Cosmetic Regulatory Definition and Classification
- Responsible Person obligations
- Cosmetic Ingredient Hotlist
- Good Manufacturing Practices (GMP)
- Notification of Cosmetic Products
Q&A Session
- Professionals in the cosmetic and personal care industries new to EU, US and Canada Cosmetics Regulatory Affairs or wishing to update their knowledge on these regulatory frameworks.
- Regulatory Affairs, Registration and Documentation Assistants/Officers/Managers and Quality Assurance professionals seeking to improve their skills in the cosmetic regulatory environment.
- R&D professionals involved in the development of cosmetic formulations for the North American market.
- Marketing professionals involved in cosmetics label preparation and market placement.
- Project Management or Business Development officers who would find knowledge of the regulatory environment useful.
Participant experience
No previous knowledge required.
Training will be in the form of an interactive workshop.
It will include presentations, discussions, and Q&A.
Docente/i
Liliana Teles
MedTech Industry: Liliana Teles is a pharmacist holding Masters in Pharmaceutical Sciences and Pharmaceutical Medicine, with more than 10 years of experience in Medical Devices and In Vitro Diagnostics Regulatory Affairs & Quality Assurance. At Critical Catalyst, her work is focused in supporting medical device Manufacturers, Distributors, and Importers in achieving regulatory compliance. Experienced in implementation and audit to Quality Management Systems according to ISO 13485 and Good Distribution Practices of medical devices. Passionate about working with dedicated teams, driving projects related to regulatory compliance in the medtech field and streamlining patients access to medical device technology.
Cosmetics Industry: With a Post-Graduation in Advanced Cosmetology and certification as Cosmetics Safety Assessor, Liliana is specialized in Regulatory Affairs, Product Development and Quality Assurance for the cosmetics industry. At Critical Catalyst, Liliana works closely with manufacturers, importers and distributors of cosmetic products located worldwide to ensure compliance with regulations and safe access to the global market.
Online Training – 2 modules
MODULE 1 | 03 June 2025 from 2:00 pm to 5:30 pm CEST
MODULE 2 | 05 June 2025 from 2:00 pm to 5:30 pm CEST
After the registration, you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 790,00* (until 06 May 2025)
Ordinary: € 980,00*
Freelance – Individual – Academy – Public Administration: € 565,00*
* for Italian companies: +22% VAT
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Newsletter
Ilaria Butta
Events & Training Manager
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
