A practical cosmetovigilance learning platform for Responsible Persons, distributors, safety assessors, quality teams and professionals who may receive cosmetic safety information — from recognition and case assessment to serious undesirable effect reporting, CPSR feedback, trend review and corrective action.
This platform focuses on EU cosmetic products under Regulation (EC) No 1223/2009 and Greek implementation context. It is an educational resource, not a substitute for a Responsible Person, safety assessor, competent authority, medical judgement, company SOP or legal/regulatory advice.
Cosmetovigilance is the post-market safety discipline that collects, evaluates and learns from undesirable effects associated with cosmetic products. The EU framework distinguishes an undesirable effect from a serious undesirable effect and creates specific duties for serious cases.
An adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product.
An undesirable effect resulting in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies, immediate vital risk or death.
Available UE/SUE data belong in the cosmetic product safety report and may change the safety assessment, warnings, product controls or other corrective measures.
Greek Joint Ministerial Decision D3(a)/91512 (Government Gazette B 25/15.01.2018) establishes national implementation provisions and a cosmetovigilance system. Use the current EOF cosmetics legislation and instructions for real Greek cases. EOF legislation ↗
Choose the characteristics of a hypothetical case. The tool teaches what to consider first and how safety, quality and regulatory routes can interact. Do not enter real personal data; this is not a reporting portal.
The first task is to separate a human-health undesirable effect from a quality-only complaint, then check seriousness and the context of use.
For real cases, follow the current approved company process, Responsible Person/safety assessor governance, national competent-authority instructions and applicable law.
Each module includes concise theory, practical learning objectives, case-thinking prompts and official regulatory references. Start with foundations, then move toward safety-system oversight.
Training depth should match the chance of receiving safety information, the decisions the role makes and the obligations of the organisation. Use these as starting points for a training needs assessment, not as fixed legal curricula.
Cosmetovigilance is cross-functional. The exact job titles vary by company, but these role families commonly interact with post-market cosmetic safety.
Short memory aids for training and discussion. They are deliberately not operational SOPs and should be adapted to the company quality system.
Cosmetic legislation changes through amendments to the annexes and related measures. For real decisions, verify the current consolidated text, applicable national rules and current competent-authority instructions.
Choose a level and test reasoning about definitions, reporting, causality, CPSR feedback and safety-quality interfaces. The result is for personal learning only.
Choose a level and start. Each answer includes a concise explanation.
Key terms used across EU cosmetic safety, market surveillance and company safety systems.