MODULE 3: TOXICOLOGY 2

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MODULE 3: TOXICOLOGY 2

23. April 2024  || 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

 

GLOBAL COSMETIC PRODUCT SAFETY ASSESSMENT TRAINING

The Course Concept at a Glance: The training program, now in its fourth 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 a focus on developments under the US-MOCRA.

CCE’s team of 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 into fundamental scientific aspects. This approach ensures a comprehensive understanding of both practical applications and theoretical underpinnings.

The training unfolds across six modules over the span of a year. Each module comprises four webinars and a dedicated full online day for knowledge exchange, discussion, exercises, and support. 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. Participants can expect to gain practical skills, theoretical knowledge, and insights, positioning them as competent safety assessors in the field of cosmetic product regulations.

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: Approaching Cosmetic Products and Their Safety

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ATTENDANCE DAY ONLINE

Tuesday Tuesday Tuesday Tuesday Friday
06.02.24 13.02.24 20.02.24 27.02.24 08.03.24
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 Specifics for Fragrances and for Packaging Impurity Status and Documentation
CPSR and PIF Dual Approach to Ingredients’ Safety Substances from different Origin Ingredients Descriptors, Horizontal Legislation Good, necessary, Supporting Information
Other Cosmetics 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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ATTENDANCE DAY ONLINE

Tuesday Tuesday Tuesday Tuesday Friday
12.03.24 19.03.24 26.03.24 09.04.24 
(pot. 02.04.24)
19.04.24
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 11:00 – 17:30
Skin Structure Local Endpoint 1 Local Endpoint 2 Local Endpoint 3 Starting the Assessment
Toxicological Endpoints in Safety Assessment  Clinical Testing
Data Interpretation
Skin Irritation
Mucous Membrane
Irritation
Skin Sensitization Research Strategies for Toxicological Information 
Skin Physiology  Skin Compatibility
Sun Protection
Phototoxicity
Photosensitization
Test Methods
Filling Data Gaps  Starting CPSR Approach
LECTURER LECTURER LECTURER LECTURER LECTURER

Uwe Rossow
Annette Mehling

Uwe Rossow
Marcus Kleber Annette Mehling All Lecturers
Module 3: Toxicology 2

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ATTENDANCE DAY 
ONLINE

Tuesday Tuesday Tuesday Tuesday

Friday

23.04.24 30.04.24 07.05.24 14.05.24 31.05.24
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
TBD TBD  TBD TBD All Lecturers

 

Module 4: Exposure Criteria / Safety Margins

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ATTENDANCE DAY ONLINE

Tuesday Tuesday Tuesday Tuesday Friday
04.06.24 11.06.24 18.06.24 25.06.24 28.06.24
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

EData 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

Data use and interpretation 
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

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ReadAcross, QSAR Toolbox Exercises for Safety
Margin Calculations
LECTURER LECTURER LECTURER

LECTURER

LECTURER
TBD TBD TBD

TBD

All Lecturers
Module 5: Packaging, Stability, Microbiology

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ATTENDANCE DAY ONLINE

Tuesday Tuesday Tuesday Tuesday Friday
03.10.23 10.10.23 17.10.23 24.10.23 03.11.23
18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 18:00 – 19:30 11:00 – 17:30
Packaging Materials  Packaging -Information Requirements Product Stability,  PhysChem Characteristics, Photostability Microbiology, Types of Microorganisms Stability Testing in Various Product Categories
Impurities and Additives Applicability of Food Law  Packaging Compatibility  Challenge Testing Practical Approach to Packaging Assessment
Recycled Packaging  Packaging Assessment    Shelf Life, PAO Microbiological Purity How to read  Microbiological Tests
LECTURER LECTURER LECTURER LECTURER LECTURER
Alex vd Burgh Uwe Rossow Natalia Georgiou Uwe Rossow All Lecturers
Module 6: Animal Testing Ban / GMP / Claims / CPSR

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ATTENDANCE DAY ONLINE

Tuesday Tuesday Tuesday Tuesday Friday
07.11.23 14.11.23 21.11.23 28.11.23 08.12.23
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 & resulting Requirements Claims, Labelled Warnings and Instructions of Use The CPSR – Format, Product Identification, & Traceability, Approach Borderline Product / Interface between Efficacy and Safety How to prepare a CPSR – practical exercise with an example formulation
Quality of Testing Protocols Results from SA to be recognized in Labelling Assessor Credentials, Key SA Contents, Conclusion & Reasoning Cosmetovigilance > UEs and SUEs Proper Documentation
GMP: Principles & Contribution to Product Safety Functionality and Efficacy – Testing   Grey zones between Safety Assessor and Responsible Person Statistics Challenges / Inspections
LECTURER LECTURER LECTURER LECTURER LECTURER
Marcus Kleber
Fabienne Hins
Alex vd Burgh Uwe Rossow Mabel Iwobi
Uwe Rossow
All Lecturers

Why us?

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Independent safety assessors lecture based on experiences from daily work and projects

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Speed-up of the learning curve of future safety assessors, update of the skills of experienced safety assessors

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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

Course Structure and Costs

Fee Structure: €1,400.00 per module
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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; thus Covid-safe

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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 markets with further advances one’s cosmetic sciences. 
Upon successful course completion, CCE will issue its own certificate for performing Safety Assessments. To perform SAs for clients, companies, etc., it’s really more about what one gleans from the training and fully applies it to their professional regulatory work!

Registration for CCE Safety Assessment e-Training Modules

Starting February 2024

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

Terms & Conditions

Data Protection Declaration

FAQs

With Brexit a ‘done deal’, 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. Wherever decisions are based on specific legal requirements these are depicted during the course and can be translated from this description 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 and regulatory affairs. All areas will be addressed during the training program, and it will also stimulate and demand to be complemented by the active engagement of the participants. The experience shows that the participants come with various backgrounds; therefore, everybody has strength and weaknesses and these need to be balanced in the self learning phases.

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.

Cosmetics Consultants Europe (CCE) is a pan-European industry association uniting consultant working in the cosmetics, cosmetic ingredients and borderline industries –

For more information email to Steven L. Hanft: sg@ccecosmetic.org