Cosmetics regulation in Europe and the latest news
This training allows you to develop or validate your knowledge in the field of cosmetics. You will find all the necessary information to better understand the constraints as well as the opportunities to bring a product to market that complies with regulations.
3 Afternoons
No level required
Remote Training (Webinar)
If a specific adaptation is needed, particularly in relation to a disability, please do not hesitate to let us know.
- 24/11, 25/11 et 27/11
Presentation
The basics of Regulation 1223/2009 are covered to clearly define the regulatory area presented. The different market entry procedures (Product Information File, CPNP notification, etc.) as well as the requirements regarding formulation and labeling form the core of this training. Communication, claims, and the expected level of evidence will also receive special attention.
Anyone involved in the cosmetics development and/or marketing process (CEO, project manager, R&D, regulatory or marketing departments).
No special prerequisites.
Objectives
- Validate your regulatory knowledge concerning cosmetics.
- Understand the constraints.
- Study and experiment on one or more concrete cases.
- Q&A – Exchange and debate on the subject.
- Validate your regulatory knowledge concerning cosmetics.
- Understand the constraints.
- Study and experiment on one or more concrete cases.
- Q&A – Exchange and debate on the subject.
Sessions
Program
- Attendees’ connection
- Presentations / Round table of everyone’s expections and objectives
Cosmetic Product Regulation in Europe: Focus on the Product Information File
– The regulation of cosmetics in Europe
– Regulation 1223/2009 EC on cosmetic products:
– Objectives
– Definitions
– How to compile my product information file?
– File structure:
– Sections other than the safety report
– The safety report
– The 10 parts that make up section A of the report
Cosmetic Safety Assessment
Post-Marketing Surveillance: Cosmetovigilance, How to Implement Your Procedure?
- Regulatory obligations:
– Safety concept: central aspect of the regulation
– Regulatory obligations
– Regulatory definitions, severity criteria, reporting to authorities - Cosmetovigilance cases:
-Definition of a case
– Causality assessment methods
– Responsibilities
– Steps in case management
– Different types of reactions to cosmetic products - Case study:
– Use of collected data / evaluation / decision-making
– Integration of data into the Product Information File
– Evaluation, reporting - Market surveillance of cosmetic products:
– General overview
– Focus on France (ANSES and DGCCRF, inspections, and penalties…)
- Attendees’ connection
- Presentations / Round table of everyone’s expections and objectives
Cosmetic Claims, How to Communicate Safely?
- Context and regulatory texts:
– Self-regulation regime
– The six common criteria of the European Regulation: definition and examples - Case study:
– “Free-from” claims: the “spirit” of the text, what is allowed, what is prohibited
– “Hypoallergenic” claim: the “spirit” of the text, how to justify this type of claim? - How to justify a claim?
– Regulatory context of clinical testing for cosmetic products
– Types of clinical tests: safety, use, effectiveness
– Methodologies of safety and efficacy tests, proof of claimed effects - Website / Advertising / Influencers
=> Quiz, exercises: Validate your knowledge
Trainers
Means and modalities
The training will be conducted via the Teams video conferencing tool (a link will be sent to participants before the session for access). The training material (PowerPoint) will be presented through a combination of lectures and discussions with the trainers. Educational documentation will be provided in electronic format. A knowledge assessment must be completed at the end of the training. A certificate of attendance will be issued.
Prices
2 Afternoons: 24 & 25 November 2025 (1.30pm- 5.00pm) - 750€HT soit 900€TTC
For your requests for support by your Skills Operator (OPCO) Pharmanager Development has an activity declaration number: 5249 03216 49.
For your requests for support by your Skills Operator (OPCO) Pharmanager Development has an activity declaration number: 5249 03216 49.
Do you want tailor-made training?
Our experts can study with you your expectations and objectives on themes related to nutrition, health and beauty, and offer you adapted training, in person at your premises or in ours, or remotely.