Cosmetic Safety Assessment e-Training Module 4 Commences

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Cosmetic Safety Assessment e-Training Module 4 – EXPOSURE CRITERIA / SAFETY MARGINS

10. May 2022 || 12 EST 17 GMT 18-19.30 CET

GLOBAL COSMETIC PRODUCT SAFETY ASSESSMENT TRAINING

The Course Concept at a Glance: This coming February 2022, Cosmetics Consultants Europe (CCE) will commence its ‘online’ Cosmetic Safety Assessment ‘e-Training courses. All modules will be taught by industry experts as such assuring contents close to the cosmetics safety assessment practice

The training program will enable participants to perform Safety Assessments (SAs) for cosmetic products in both the EU & UK, which are formulated, manufactured and marketed on a worldwide scale.

The scientific and regulatory concept is based on the European Regulation N° 1223/2009 on Cosmetic Products and the related guidance publications, while also support for application under other regulatory frameworks is part of the curriculum.

Target Groups

Experienced Safety Assessors (SAs) and beginners in the field

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

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

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

Members of Regulatory Authorities

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: Regulation on cosmetic products and their safety

ONLINE SEMINARS DATES – Next dates for Module 1 will be in January 2023
Training Goals & Principles	Principles of Safety Assessment	Annex I / CPR	Raw Material Criteria	Practical Approach to Safety Assessment
The EU’s Common Market & Industry Regulation	The SCCS – Notes of Guidance	Information Requirements	Intrinsic Properties Ingredient Origin	Data Collection, Impurity Research
Cosmetics Product Regulation / PIF	Regulated Substances	Ingredient Descriptors (INCI, EC, etc.)	Impurities	Documentation
LECTURER	LECTURER	LECTURER	LECTURER	LECTURER
tba	tba	tba	tba	tba

Module 2: Toxicology 1

1	2	3	4	ATTENDANCE DAY ONLINE
Tuesday	Tuesday	Tuesday	Tuesday	Friday
22.02.22	01.03.22	08.03.22	15.03.22	25.03.22
18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	09:00 – 17:00
Toxicological Endpoints Safety Assessment	Skin Sensitization	Skin Irritation	Phototoxicity	Research Strategies for Toxicological Information
Skin Physiology	Test Methods	Mucous Membrane Irritation	Photosensitization	Filling Data Gaps Starting a CPSR
LECTURER	LECTURER	LECTURER	LECTURER	LECTURER
U. Rossow A. Mehling	A. Mehling	M. Kleber U. Rossow	M. Kleber	A. Mehling M. Kleber U. Rossow

Module 3: Toxicology 2

1	2	3	4	ATTENDANCE DAY ONLINE
Tuesday	Tuesday	Tuesday	Tuesday	Friday
29.03.22	05.04.22	12.04.22	26.04.22	06.05.22
18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	09:00 – 17:00
Acute Oral Toxicity	Genotoxicity	Carcinogenicity	Repeated Dose Toxicity (Oral, Dermal)	Data Use and Interpretation
Acute Toxicity (Dermal, Inhalation)	Reproduction Toxicity	Uncertainty Factors	Repeated Dose Toxicity (Inhalation)	Developing Assessment Strategies
ADME	Test Methods, Endpoint NOAEL	Relevance of Toxicogical Endpoints	Endpoint NOAEC	Data Sources
LECTURER	LECTURER	LECTURER	LECTURER	LECTURER
Prof. C. Martin	Prof. D. Yildiz	Prof. D. Yildiz	Prof. C. Martin	Prof. C. Martin Prof. D. Yildiz

Module 4: Exposure Criteria / Safety Margins

1	2	3	4	ATTENDANCE DAY
Tuesday	Tuesday	Tuesday	Tuesday	Friday
10.05.2022	17.05.2022	24.05.2022	31.05.2022	03.06.2022
18:00 – 19:30CET	18:00 – 19:30CET	18:00 – 19:30CET	18:00 – 19:30CET	11:00 – 17:30CET
Product Application	Exposure 1	Exposure 2	Data Gaps	Practical Application
Consumer Group Specifics / Skin Types	Exposure Pathways – oral, dermal, inhalative	Exposure to the Cosmetic Product	TTC Concept NoG: Appendix 13 and TTC approach to botanical extracts	Data use and interpretation (practical exercises)
Normal and Reasonably Foreseeable Use	Dose Descriptors (LD50, LC50, EC50, NOAEL, LOAEL, ADI, TDI, etc.)	Exposure to the Substances	Extrapolations & Approaches in Cases of Data Gaps	Discrepancies in SPF Determination and Exposure Presentation
Specifics for various product groups: – Fragrance Assessment – Baby products	Weight of Evidence Approach	Exposure to Impurities and Migrant Substances	ReadAcross, QSAR Toolbox	Calculation of Safety Margins (formulation examples)
LECTURER	LECTURER	LECTURER	LECTURER	LECTURER
Celia Campos	Alex van der Burgh	Uwe Rossow	Marcus Kleber	ALL Lecturers

Module 5: Packaging, Stability, Microbiology

1	2	3	4	ATTENDANCE DAY ONLINE
Tuesday	Tuesday	Tuesday	Tuesday	Friday
04.10.22	11.10.22	18.10.22	25.10.22	04.11.22
18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	09:00 – 17:00
Packaging Materials	Packaging – Information Requirements	Product Stability PhysChem Characteristics Photostability	Microbiology Types of Microorganisms	Stability Testing in Various Product Categories
Impurities & Additives	Applications 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
A. vd Burgh	U. Rossow	N. Georgiou	U. Rossow	A. vd Burgh U. Rossow N. Georgiou

Module 6: Animal Testing Ban / GMP / Claims / CPSR

1	2	3	4	ATTENDANCE DAY ONLINE
Tuesday	Tuesday	Tuesday	Tuesday	Friday
08.11.22	15.11.22	22.11.22	29.11.22	09.12.22
18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	09:00 – 17:00
Animal Testing / Quality / GMP	Claims / Efficacy	Borderline Products / Cosmetovigilence / Statistics	CPSR – Key Contents	Practical Application
Animal Testing Ban & resulting Requirements	Labelled Warnings and Instructions of Use	Borderline between Efficacy and Safety	CPSR – Format	CPSR Format, Product Description, Product Traceability, Completion
Quality of Testing Protocols	Safety Principles in Labelling	Undesirable Effects / Serious Undesirable Effects	Assessor Credentials, Conclusion and Reasoning	CPSR (practical exercise)
GMP: Principles & Contribution to Product Safety	Functionality and Efficacy – Testing	Statistics	Greyzones between Safety Assessor and Responsible Person	Proper GMP Documentation
LECTURER(S)	LECTURER(S)	LECTURER(S)	LECTURER(S)	LECTURER(S)
M. Kleber A. Struessmann	A. vd Burgh	M. Iwobi U. Rossow	U. Rossow	M. Kleber A. vd Burgh M. Iwobi U. Rossow

Why us?

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

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

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

Course Concept: The Modules are interlinked, but not strictly consecutive – any module provides a benefit on its own

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

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

Attendance Days: All day is fully ONLINE; thus Covid-safe

Exams: Each online-seminar is supervised by written tasks; any Attendance Day is ended with a written exam

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

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 2022

First Name

Family Name

Email Address

Company Name

Billing address & Payer’s Name

City

Country

ZIP Code

VAT Number

Please select Module(s) for Registering your participation in: Please select Module(s) for Registering your participation in: Module 2 - Toxicology 1 (Feb 2022) Module 3 - Toxicology 2 (Mar 2022) Module 4 - Exposure / Safety Margins (May 2022) Module 5 - Packaging / Stability / Microbiology (Oct 2022) Module 6 - ATB / GMP / Claims / CPSR (Nov 2022) Module 1 - Regulatory / Annex 1 / Raw Materials (Jan 2023)

Terms & Conditions Terms & Conditions I agree with the General Terms and Conditions for the e-Training of Cosmetics Consultants Europe (CCE) - Download GTC

Data Protection Declaration Data Protection Declaration I agree with the Data Protection Declaration of Cosmetics Consultants Europe (CCE) - Download DPD

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