MODULE 1: Approaching Cosmetic Products and Their Safety

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MODULE 1: Approaching Cosmetic Products and Their Safety

Begins May 27, 2025  || 12 EST · 17 GMT · 18-19:30 CET

A LIVE E-LEARNING COURSE PROVIDING SCIENTIFIC UNDERSTANDING, EXPERTS’ KNOWLEDGE AND
THEIR PRACTICAL EXPERIENCES ON COSMETIC PRODUCT SAFETY ASSESSMENT
For further info about CCE online safety assessment training modules,
pls. contact Steven L. Hanft, Business Communications, CCE
Email: steven.hanft@cpsr-education.com

 

Register now!

COSMETIC PRODUCT SAFETY ASSESSMENT ONLINE TRAINING

CCE Course at a Glance: The training program, now in its 5th season, aims to empower participants with the skills necessary to conduct Safety Assessments (SAs) for cosmetic products with global reach. The foundation of the scientific and regulatory principles lies in the European Regulation N° 1223/2009 on cosmetic products and its associated guidance publications. Yet, the curriculum also provides support for applications under further global regulatory frameworks, with one focus on developments under the US-MOCRA.

CCE’s team of EU / UK safety assessors, alongside other international CCE experts, will share their practical experiences gleaned from hands-on daily practice in performing SAs and ensuring regulatory compliance. Additionally, the program will feature lecturers from universities and industry who will contribute insights on fundamental scientific aspects. This approach ensures a comprehensive understanding of both practical applications and theoretical underpinnings.

The training unfolds across 6 online modules over the span of one year. Each module comprises four webinars and a dedicated full online day for knowledge exchange, discussion, exercises, and support. Upon completing tht entire course, the collective content of the modules equips participants with the necessary expertise to proficiently perform cosmetic product safety assessments upon completing the entire course. Overall, the course provides a well-rounded and in-depth education, blending real-world application with academic rigor.

Target Groups

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Experienced Safety Assessors (SAs) and beginners in the field

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Department Staff from: R&D, Regulatory Affairs, QA/QC, Testing, Formulation

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Responsible Persons (RPs) under the context of the Cosmetics Product Regulation

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Members of the Cosmetics, Chemicals/Raw Materials, Pharmaceutical, Packaging, Fragrance Industries

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Members of Regulatory Authorities

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All graduates in Toxicology, Chemistry, Biology, Pharmacology, Life Sciences, Product Technology with interest in continuing education and specialization

Our Methodology

6 Training Modules: Each module consists of 4 online-seminars of 90 minutes and a full Attendance Day

MODULE 1: Regulatory Affairs, Approaching Cosmetic Products and Their Safety

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2

3

4

ATTENDANCE DAY ONLINE
Tuesday Tuesday Tuesday Tuesday Friday
27.05.2025 03.06.2025 10.06.2025 17.06.2025 27.06.2025
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 11:00 – 17:30
Regulations for Cosmetic Products Fundamentals for Safety Assessment Raw Material Criteria Raw Material Evaluation A Practical Approach to Safety Assessment
Training Goals Principles of Safety Assessment Safety Annex I – The CPSR
 Data Research
EU Common Market + its  Regulation The SCCS – Notes of Guidance Composition Ingredients Descriptors, Impurity Status and Documentation
CPSR and PIF Dual Approach to Ingredients’ Safety Substances from different Origin  Horizontal Legislation Good, necessary and Supporting Information
Other Cosmetics legal Frameworks Substances regulated in the CPSR Annexes Impurities’ Relevance for safety Sources for Impurities: Manufacturing Process Cosmetic Manufacturing: Where Hazards May Appear
LECTURER LECTURER LECTURER LECTURER LECTURER

Raphael Sauerwein

 Elina Hotuleva Uwe Rossow Ute Wollenweber All Lecturers
Module 2: Toxicology 1

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2

3

4

ATTENDANCE DAY ONLINE
Tuesday Tuesday Tuesday Tuesday Friday
07.10.25 14.10.25 21.10.25 28.10.25
 07.11.25
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 11:00 – 17:30
Skin Structure Local Endpoint 3 Local Endpoint 2 Local Endpoint 1 Starting the Assessment
Toxicological Endpoints in Safety Assessment  Clinical Testing
Data Interpretation		 Skin & Mucous
Membrane Irritation		 Skin Sensitization Research Strategies for Toxicological Information 
Skin Physiology  Skin Compatibility
Sun Protection		 Phototoxicity
Photosensitization		 Test Methods
 Filling Data Gaps
CPSR Approach
LECTURER LECTURER LECTURER LECTURER LECTURER

Lecturer

 Lecturer Lecturer Lecturer All Lecturers
Module 3: Toxicology 2

1

2

3

4

ATTENDANCE DAY
ONLINE
Tuesday Tuesday Tuesday Tuesday

Friday
11.11.25 18.11.25 25.11.25 01.12.25 12.12.25
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 11:00 – 17:30
Acute Toxicity Systemic Toxicity 1 Systemic Toxicity 2 Chronic Toxicity Assessment Approach
ADME  
 Genotoxicity
 Carcinogenicity
 Repeated Dose Toxicity (Oral, Dermal) Data Use and Interpretation
Acute Oral Toxicity Toxicity for Reproduction Endocrine
Disruptors		 Repeated Dose Toxicity (Inhalation) Assessment Strategies
Acute Derma +
Inhalation Toxicity		 Test Methods,
Endpoint NOAEL		 Uncertainty Factors  Endpoint NOAEC Data Sources
LECTURER LECTURER LECTURER LECTURER LECTURER
Lecturer Lecturer Lecturer Lecturer All Lecturers

 

Module 4: Exposure Criteria / Safety Margins / TTC

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2

3

4

ATTENDANCE DAY ONLINE
Tuesday Tuesday Tuesday Tuesday Friday
03.02.26 10.02.26 17.02.26 24.02.26 06.03.26
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30

18:00 – 19:30

 11:00 – 17:30
Product Application Exposure 1 Exposure 2

Data Gaps

 Practical Application
Consumer Group
Specifics / Skin Types		 Exposure to the Cosmetic Product External + Internal
Exposure
Exposure Pathways

TTC Concept
TTC approach to
botanical extracts

 DExercises on POD calculation and UF choice
Normal + Reasonably
Foreseeable Use		 Exposure to Substances Risk Assessment
Calculations SED, MoS

Extrapolations & Approaches in Cases of Data Gaps

TTC Examples
Product Group Specifics:
– Fragrances
– Baby products		 Exposure to Impurities and Migrant Substances Dose Descriptors
Weight of Evidence
 Read-across, QSAR Toolbox Exercises for Safety
Margin Calculations
LECTURER LECTURER LECTURER

LECTURER

 LECTURER
Lecturer Lecturer Lecturer

Lecturer

 All Lecturers
Module 5: Packaging, Stability, Microbiology

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2

3

4

ATTENDANCE DAY ONLINE
Tuesday Tuesday Tuesday Tuesday Friday
10.03.26 17.03.26 24.03.26 31.03.26 17.04.26
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 11:00 – 17:30
Packaging I Packaging II Product Stability Microbiology Practical application
Types of packaging
Implications on Safety
 Cosmetics packaging
Information. Requirements		 PhysChem Characteristics
Stability, Photostability
  Types of Microorganism Reading & Interpreting
chalenge + bioburden test
Plastics Packaging Impurities and Additives
Recicled Packaging		 Packaging Assessment –  Food Law  Testing:
Product Stability
Packaging Compatibility 		 Bioburden Testing
Challenge Test		 Packaging Assessment
Food Contact Framework + Certificates
Aerosol Packaging  Packaging Assessment – Safety Criteria Shelf Life, PAO Purity of Raw Maaterials
Products & Production		 Read-across Approach performance of Migration Tests
LECTURER LECTURER LECTURER LECTURER LECTURER
Lecturer Lecturer Lecturer Lecturer All Lecturers
Module 6: Animal Testing Ban / GMP / Claims / CPSR

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2

3

4

ATTENDANCE DAY ONLINE
Tuesday Tuesday Tuesday Tuesday Friday
21.04.26 28.04.26 05.05.26 12.05.26 22.05.26
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 11:00 – 17:30
Animal Testing / Quality / GMP Claims, Efficacy CPSR Borderline / Cosmetovigilence Practical Applications
Animal Testing Ban
Test Protocol Quality		 Claims, Warnings and Instructions of Use The CPSR – Format, Key Contents.
Assessor Credentials
Conclusion & Reasoning		 Functionality and Efficacy Testing.
Borderline between Efficacy and Safety		 How to prepare a CPSR (practical exercise with examples)
GMP: Principles & Contribution to Product Safety Safety Assessment results to be recognized in product labelling Grey-zones between Safety Assessor and Responsible Person.
Statics		 UEs and SUEs Challenges / Inspections
LECTURER LECTURER LECTURER LECTURER LECTURER
Lecturer Lecturer Lecturer Lecturer All Lecturers
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Course Concept: The Modules are interlinked, but not strictly consecutive – any module provides a benefit on its own

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Tutorial: On-line self-learning phases are carried out before the full Attendance Day

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Flexible Learning: Due to the course structure participation is easily manageable while working on the job

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Attendance Days: All day is fully ONLINE; no wasted time for travel applies
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Exams: Each online-seminar is supervised by written tasks; any Attendance Day is ended with a written exam

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Predictability: All six modules will be offered within one calendar year

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Achievements: CCE’s Safety Assessment Modules will enable participants to perform SAs for cosmetics according to the Cosmetics Product Regulation N° 1223/2009.  Our industry experts will contribute their hands-on experiences from doing SAs.  

Our e-Training will support those striving to do safety assessments for both the EU & UK as well as for global markets. 

Upon successful course completion, CCE will issue a Certificate.

Fees

  • €1.400 per Module: Purchase all 6 Modules, get 1 Free!
  • Includes an online Attendance Day with Q&A session (Fridays, 11-17.00 CET)
  • Discounts for members of CCE, IBA, SCC-USA, SCS-UK / Registering company groups

Registration for CCE Safety Assessment e-Training Modules

Starting Mai 2025

Please select Module(s) for Registering your participation in:

Terms & Conditions

Data Protection Declaration

CCE’s Online Course Requirement, Completion & contacts

To participate, a university degree in a science field, such as Biology, Chemistry, Toxicology, or similar, is preferred and required for signing SAs under the EU’s Cosmetics Regulation. However, the key to successfully completing the course is the participant’s willingness to learn and dedicate the time and attention necessary to complete all tasks.

Contact for addressing further questions: 

For regulatory affairs courses in Australia and New Zealand

Regulatory Training Direct

+ Info

Why us?

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Independent safety assessors lecture on the basis of their experiences from daily work and projects
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The learning curve for future safety assessors will be accelerated, while experienced safety assessors will gain the necessary updates on their skills and knowledge
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Continously updated state of the art knowledge of science and regulatory affairs

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Individual advice and feedback from the lecturers

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Testimonials

“Participation in the training allows participants to compare the presented information with their own real-world experience in the regulatory field and to gain new insights. The information is concise, specific, comprehensive, professional, and presented in an engaging manner. The training occurs in a dialogue between the lecturer and the participants. The training opens new horizons for professional growth. Highly recommended”

Julia K., Kyiv Ukraine

“I really enjoyed Attendance Day for each Module. Attendance Days are intense with high value because of the active discussions and information provided. I really like that each Attendance Day starts with summary of hot topics.”

Iveta K., QA Manager, USA

“The attendance day was extremely helpful. Hearing all of the presenters discuss the participants’ questions was very insightful.”

Daniel S., Research Scientist, USA

“I thought the presenters were great. I loved that the sessions were recorded for reference throughout the week after each session. I also enjoyed the content. I appreciated that the start time of the all-day session was moved to later in the day to help accommodate the US participates.”

Adrienne G., Senior Regulatory Specialist, USA

“Overall, the training is a well-structured and balanced theory with practical knowledge, giving me the tools to confidently approach cosmetic safety assessments. It is ideal for anyone involved in product development or regulatory affairs, like me, and provides valuable insights into ensuring consumer safety.”

Maria D., Safety Assessor, USA

“This course not only met my expectations but exceeded them. I receive not only theoretical but also practical knowledge on qualitative preparation of Cosmetic Product Safety Report. The lecturers were qualified, each expert in their field. Practical examples for each module are an integral part of this course.”

Iveta K., QA Manager, USA

“Different perspectives and insights from a very broad range of presenters providing a well-rounded, academically robust learning experience that is wrapped up in real work practical applications.”

Dr Mark T., LLM, MA, PhD Csci, Managing Partner, UK

“Exchange of views between lecturers and sharing their practical experience. Plus opportunity to practice under their supervision.”

Markéta B., Ing., Czech Republic

Exposure Criteria / Safety Margins

“This final module emphasized the practical application of exposure data to assess risk. It covered critical topics like calculating the safety margins and understanding the exposure limits for various cosmetic ingredients. This module was essential for grasping how theoretical toxicology is applied to real-world product safety evaluations.”

Maria D., Safety Assessor, USA

“An insight into how complex and interdisciplinary the work of a safety assessor is. I have promoted the course in Czech Cosmetic industry Association and Society of Cosmetology.”

Markéta B., Ing., Czech Republic

“Would like to express my gratitude and appreciation for the way the training was handled and the technical knowledge of all each and all presenters, I must say I’m impressed. Having completed all 6 seminars already I can definitely say that Modules 2-4 are the most challenging (as expected I guess), and if Ok I would suggest adding either an extra Module (or at least a couple of webinars) intended only for examples and practice of Exposure Scenarios.”

Andrea P., Safety Assessor, Canada

Approaching Cosmetic Products and Their Safety

“This module was a great introduction, offering an in-depth overview of the regulatory frameworks and essential safety considerations specific to cosmetics. It helped set the context for assessing the formulation and the finished product, highlighting the importance of product safety in the market. It also covered the evaluation of the raw material.”

Maria D., Safety Assessor, USA

“All topics were relevant for me. The most challenging but at the same time most valuable part for me was Toxicology 1 and Toxicology 2 as I have not studied it in depth before. Now I have more understanding on skin sensitization and irritation, phototoxicity, acute and systemic toxicity.”

Iveta K., QA Manager, USA

Toxicology 1 & 2

“The toxicology modules were personally the most challenging but also the core of the training, diving into fundamental toxicological principles and their applications to cosmetics. Toxicology 1 focused on basic concepts like dose-response relationships and hazard identification, while Toxicology 2 expanded on more advanced topics like mutagenicity, reproductive toxicity, and dermal absorption. These sections were particularly insightful in understanding the biological effects of ingredients and how to evaluate their potential risks.”

Maria D., Safety Assessor, USA

“So dynamic and interactive course, also multidisciplinary with multitopic, and with that I have now a better and more general picture of cosmetics world.”

Patricia A., Senior Regulatory Officer, Ireland

“Very detailed and thorough explanation of skin sensitization. There was a lot of information and it was hard to follow at times, but going through the presentation a second time helped me nail down all of the information.”

Daniel S., Research Scientist, USA

“The speakers were experts on their field, I have learned a lot from them and they were very willing to answer to any questions especially during the attendance day.”

Maria S., Pharmaceutical Services, Cyprus

“This course not only met my expectations but exceeded them. I receive not only theoretical but also practical knowledge on qualitative preparation of Cosmetic Product Safety Report. The lecturers were qualified, each expert in their field. Practical examples for each module are an integral part of this course.”

Patricia A., Senior Regulatory Officer, Ireland

“My overall opinion is very positive, I would definitely recommend it to others and I am looking forward to the next Modules.”

Maria S., Pharmaceutical Services, Cyprus

|

Testimonials

“Participation in the training allows participants to compare the presented information with their own real-world experience in the regulatory field and to gain new insights. The information is concise, specific, comprehensive, professional, and presented in an engaging manner. The training occurs in a dialogue between the lecturer and the participants. The training opens new horizons for professional growth. Highly recommended”

Julia K., Kyiv Ukraine

“I really enjoyed Attendance Day for each Module. Attendance Days are intense with high value because of the active discussions and information provided. I really like that each Attendance Day starts with summary of hot topics.”

Iveta K., QA Manager, USA

“The attendance day was extremely helpful. Hearing all of the presenters discuss the participants’ questions was very insightful.”

Daniel S., Research Scientist, USA

“I thought the presenters were great. I loved that the sessions were recorded for reference throughout the week after each session. I also enjoyed the content. I appreciated that the start time of the all-day session was moved to later in the day to help accommodate the US participates.”

Adrienne G., Senior Regulatory Specialist, USA

“Overall, the training is a well-structured and balanced theory with practical knowledge, giving me the tools to confidently approach cosmetic safety assessments. It is ideal for anyone involved in product development or regulatory affairs, like me, and provides valuable insights into ensuring consumer safety.”

Maria D., Safety Assessor, USA

“This course not only met my expectations but exceeded them. I receive not only theoretical but also practical knowledge on qualitative preparation of Cosmetic Product Safety Report. The lecturers were qualified, each expert in their field. Practical examples for each module are an integral part of this course.”

Iveta K., QA Manager, USA

“Different perspectives and insights from a very broad range of presenters providing a well-rounded, academically robust learning experience that is wrapped up in real work practical applications.”

Dr Mark T., LLM, MA, PhD Csci, Managing Partner, UK

“Exchange of views between lecturers and sharing their practical experience. Plus opportunity to practice under their supervision.”

Markéta B., Ing., Czech Republic

Exposure Criteria / Safety Margins

“This final module emphasized the practical application of exposure data to assess risk. It covered critical topics like calculating the safety margins and understanding the exposure limits for various cosmetic ingredients. This module was essential for grasping how theoretical toxicology is applied to real-world product safety evaluations.”

Maria D., Safety Assessor, USA

“An insight into how complex and interdisciplinary the work of a safety assessor is. I have promoted the course in Czech Cosmetic industry Association and Society of Cosmetology.”

Markéta B., Ing., Czech Republic

“Would like to express my gratitude and appreciation for the way the training was handled and the technical knowledge of all each and all presenters, I must say I’m impressed. Having completed all 6 seminars already I can definitely say that Modules 2-4 are the most challenging (as expected I guess), and if Ok I would suggest adding either an extra Module (or at least a couple of webinars) intended only for examples and practice of Exposure Scenarios.”

Andrea P., Safety Assessor, Canada

Approaching Cosmetic Products and Their Safety

“This module was a great introduction, offering an in-depth overview of the regulatory frameworks and essential safety considerations specific to cosmetics. It helped set the context for assessing the formulation and the finished product, highlighting the importance of product safety in the market. It also covered the evaluation of the raw material.”

Maria D., Safety Assessor, USA

“All topics were relevant for me. The most challenging but at the same time most valuable part for me was Toxicology 1 and Toxicology 2 as I have not studied it in depth before. Now I have more understanding on skin sensitization and irritation, phototoxicity, acute and systemic toxicity.”

Iveta K., QA Manager, USA

Toxicology 1 & 2

“The toxicology modules were personally the most challenging but also the core of the training, diving into fundamental toxicological principles and their applications to cosmetics. Toxicology 1 focused on basic concepts like dose-response relationships and hazard identification, while Toxicology 2 expanded on more advanced topics like mutagenicity, reproductive toxicity, and dermal absorption. These sections were particularly insightful in understanding the biological effects of ingredients and how to evaluate their potential risks.”

Maria D., Safety Assessor, USA

“So dynamic and interactive course, also multidisciplinary with multitopic, and with that I have now a better and more general picture of cosmetics world.”

Patricia A., Senior Regulatory Officer, Ireland

“Very detailed and thorough explanation of skin sensitization. There was a lot of information and it was hard to follow at times, but going through the presentation a second time helped me nail down all of the information.”

Daniel S., Research Scientist, USA

“The speakers were experts on their field, I have learned a lot from them and they were very willing to answer to any questions especially during the attendance day.”

Maria S., Pharmaceutical Services, Cyprus

“This course not only met my expectations but exceeded them. I receive not only theoretical but also practical knowledge on qualitative preparation of Cosmetic Product Safety Report. The lecturers were qualified, each expert in their field. Practical examples for each module are an integral part of this course.”

Patricia A., Senior Regulatory Officer, Ireland

“My overall opinion is very positive, I would definitely recommend it to others and I am looking forward to the next Modules.”

Maria S., Pharmaceutical Services, Cyprus

FAQs

Can I use the course for cosmetics assessment under UK law?

The course is teaching how to perform a science-based risk assessment on cosmetics and their ingredients. This approach is applicable independently from a regulatory scheme. The EU’s framework is chosen as base structure because in its legal text the assessment is laid down in detail in regard to necessary requirements and the assessment steps are supported by comprehensive guidance publications. During the course, various examples will be depicted where decisions are based on specific legal requirements and how these can be translated into other worldwide regulatory frameworks.

What qualification do I need to have to take the module(s)?
Cosmetics safety assessment is a complex exercise involving interdisciplinary scientific approaches in the fields of toxicology, chemistry, pharmacology, biology/life sciences, as well as product and packaging technology, regulatory affairs, etc. All areas will be addressed during the training program. The experience shows, that the participants come with various backgrounds; therefore, everybody has strengths and weaknesses and these need to be balanced in the self-learning phases. Complementary, the course will demand and stimulate the active engagement of the participants.
Do I need an academic degree for attending the course?
The course can be attended and successfully completed without owning an academic degree, as it was observed in practice; yet, based on the existing strong engagement of the participant. However, under the EU’s cosmetic regulation it is required to possess a ‘diploma or other evidence of formal qualifications’ [Reg. (EC) 1223/2009, Art. 10 (2)], in order to legally sign on as Safety Assessor.
How much time is required to complete the course successfully?

Solid data on intrinsic properties of product ingredients are required, as well as on the potential occurrence of harmful contaminants and microbiological burden. This data and further information on the properties and effects of substances and formulations serve as the basis for exposure and risk assessments. The demand on knowledge and skills of product safety assessors is enormous and is constantly growing based on new scientific and regulatory results. Therefore, the learning is ongoing and the course is giving the start to the continuous learning approach.