Cosmetic Safety Assessment e-Training Free Demo

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Cosmetic Safety Assessment e-Training Free Demo

14. April 2021 || 12EST 17GMT 18-18.45CEST 19TRT-IsST

Scientific and Teaching Concept

Educational Requirements

Worldwide Scope

Discussion

GLOBAL COSMETIC PRODUCT SAFETY ASSESSMENT TRAINING

The Course Concept at a Glance: The training program will enable participants to perform Safety Assessments (SAs) for cosmetic products, 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.

Lecturers from the RWTH Aachen University will provide a profound science background, while international CCE experts will contribute experiences from their hands-on daily practise of performing SAs and seeking regulatory compliance.

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: The European Union’s regulation on cosmetic products and their safety

ONLINE SEMINARS DATES
1	2	3	4	ATTENDANCE DAY
Tuesday	Tuesday	Tuesday	Tuesday	Friday
25.05.21	01.06.21	08.06.21	15.06.21	25.06.21
18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	09:00 – 17:00
The European Union and its industry regulation	Regulation (EC) 1223/2009 on Safety Assessment	Cosmetics‘ and horizontal legislation	Raw Material Criteria	Practical Approach to Safety Assessment
Introduction-Training Goals & Principles	Principles of Safety Assessment	Annex I – CPSR Information Requirements	Raw Material Sources – Manufacturing Processes	How to do a raw material safety assessment – data collection, data research, impurity status, documentation
The EU’s Common Market	The Scientific Committee for Consumer Safety – Notes of Guidance	Specifics for Fragrances	Intrinsic Properties of Substances	Evaluation what is good, necessary, supporting information – (practical exercises)
The Cosmetics Product Regulation	The dual Approach towards Ingredients’ Safety	Raw Materials, Ingredients Ingredient Descriptors (INCI, EC, etc.)	Substances from different Origin	Cosmetic manufacturing: Where hazards may appear – Location visit (TBD)
The PIF	Substances regulated in the Annexes	Impurities’ Sources and their Relevance for Product Safety	Impurities from Manufacturing and their Relevance for Product Safety
LECTURER	LECTURER	LECTURER	LECTURER	LECTURER
tba	tba	tba	tba	tba

Module 2: Toxicology 1

ONLINE SEMINAR DATES
1	2	3	4	ATTENDANCE DAY ONLINE
Tuesday	Tuesday	Tuesday	Tuesday	Friday
tba	tba	tba	tba	tba
18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	09:00 – 17:00
Skin Physiology	Skin Sensitization	Skin Irritation / Dermatological Tests of Cosmetic products	Skin Cancer / Clinical Signs / Phototoxicity	Practical application
Toxicological endpoints to be considered in Safety Assessments of skin care products and Cosmetics	Skin Sensitization – Toxicological considerations	Skin Irritation – Toxicological considerations	Skin cancer	Research strategies for toxicological information on raw materials
Skin physiology with special emphasis on skin absorption and metabolism, sensitization and interactions with UV light	Skin sensitization – Testing methods	Mucous Membrane Irritation – Toxicological considerations	Phototoxicity, Photosensitization	Filling data gaps: Read across, conclusions by analogy and other approaches – practical examples
		Test methods for Skin Irritation and Mucous Membrane/Eye Irritation	Clinical signs and symptoms of allergic contact dermatitis, hand eczema and other skin diseases	Start to prepare a CPSR – implement toxicological data – practical advise
LECTURER	LECTURER	LECTURER	LECTURER	LECTURER
Dr. U. Rossow Prof. Dr. Merk	Prof. Dr. Blömeke	Prof. Dr. Blömeke Dr. U. Rossow	Prof. Dr. Merk	Prof. Dr. Merk Prof. Dr. Blömeke Dr. U. Rossow

Module 3: Toxicology 2

ONLINE SEMINAR DATES
1	2	3	4	ATTENDANCE DAY ONLINE
Tuesday	Tuesday	Tuesday	Tuesday	Friday
tba	tba	tba	tba	tba
18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	09:00 – 17:00
Acute Toxicity	Systemic Toxicity 1+2	Systemic Toxicity 3	Systemic Toxicity 4+5	Practical application
Acute Toxicity (Oral, Dermal, Inhalation, including Skin/Eye Irritation and Corrosion): a) Existing test methods, b) Outlook to alternative methods c) Endpoint (LD50, EC50, etc.)	Systemic Toxicity 1 – Genotoxicity: a) Existing Test Methods, b) Outlook to Alternative Methods	Systemic Toxicity 3 – Carcinogenicity a) Existing Test Methods, b) Outlook to Alternative Methods	Systemic Toxicity 4 – Repeated Dose Toxicity (Oral, Dermal): a) Existing Test Methods, b) Outlook to Alternative Methods c) Endpoint NOAEL	Developing assessment strategies (practical exercises)
Dermal	Systemic Toxicity 2 – Toxicity for Reproduction: c) Existing Test Methods, d) Outlook to Alternative Methods e) Endpoint NOAEL	Uncertainty factors a) Route-to-route Extrapolation b) Study Design c) Study Duration	Absorption Systemic Toxicity 5 – Repeated Dose Toxicity (Inhalation): a) Existing Test Methods, b) Outlook to alternative methods c) Endpoint NOAEC	Data use and interpretation (practical exercises)
ADME		Relevance of Toxicological Endpoints for Safety Assessment		Calculation of Safety Margins (formulation examples)
LECTURER	LECTURER	LECTURER	LECTURER	LECTURER
Prof. Dr. C. Martin	Prof. Dr. D. Yildiz	Prof. Dr. D. Yildiz	Prof. Dr. C. Martin	Prof. Dr. C. Martin Prof. Dr. D. Yildiz

Module 4: Exposure Criteria / Safety Margins

ONLINE SEMINAR DATES
1	2	3	4	ATTENDANCE DAY
Tuesday	Tuesday	Tuesday	Tuesday	Friday
tba	tba	tba	tba	tba
18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	09:00 – 17:00
Product Use	Exposure 1	Exposure 2	Data Gaps	Practical application
Consumer Group Specifics / Skin Types	Exposure to the Cosmetic Product	Exposure Pathways – oral, dermal, inhalative	TTC Concept	Developing assessment strategies (practical exercises)
Normal and Reasonably Foreseeable Use	Exposure to the Substances	Dose Descriptors (LD50, LC50, EC50, NOAEL, LOAEL, ADI, TDI, etc.)	Extrapolations & Approaches in Cases of Data Gaps	Data use and interpretation (practical exercises)
Significance of the various Testing Results in Safety Assessment (SA)	Exposure to Impurities and Migrant Substances	Weight of Evidence Approach	ReadAcross, QSAR Toolbox	Calculation of Safety Margins (formulation examples)
LECTURER	LECTURER	LECTURER	LECTURER	LECTURER
Celia Campos	Uwe Rossow	Alex van der Burgh	Marcus Kleber	Celia Campos Uwe Rossow Alex van der Burgh Marcus Kleber

Module 5: Packaging, Stability, Microbiology

ONLINE SEMINAR DATES
1	2	3	4	ATTENDANCE DAY
Tuesday	Tuesday	Tuesday	Tuesday	Friday
09.02.2021	16.02.2021	23.02.2021	02.03.2021	12.03.2021
18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	18:00 – 19:30	09:00 – 17:00
Packaging Materials 1	Packaging Materials 2	Product Stability	Microbiology	Practical application
Packaging Materials – Types of Packagings and Implications on Safety	Packaging Materials in Cosmetics -Information Requirements	Physical/chemical Characteristics, Stability, Photostability: Safety Relevance and Testing	Microbiological Testing – Types of Microorganisms concerned, Testing Methods, Challenge Test	How to read/interpret a microbiological challenge test / microbiological stability test – validity and suitability
Plastics’ Packaging Production – Impurities and Additives	Packaging Assessment – Food Law applicable to Cosmetics	Product Stability Testing and Packaging Compatibility Testing	Microbiological Purity: Aspects for Raw Materials, Products and Manufacturing	Packaging material assessment – Different kinds of certificates of food contact material compliance – Traps and solutions – what if mandatory info is missing – Individual approaches (e.g. read across or performance of e.g. migration tests)
Recycled Packaging Materials	Packaging Assessment – Criteria and Points to be considered in SA	Shelf Life, PAO		laboratory – visit
LECTURER	LECTURER	LECTURER	LECTURER	LECTURER
Alex vd Burgh	Uwe Rossow	Natalia Georgiou	Uwe Rossow	Alex vd Burgh Uwe Rossow Natalia Georgiou

Module 6: Cosmetic Products Evaluation

ONLINE SEMINAR DATES
1	2	3	4	ATTENDANCE DAY
Tuesday	Tuesday	Tuesday	Tuesday	Friday
13.04.2021	20.04.2021	27.04.2021	04.05.2021	14.05.2021
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 / Assessor Credentials	Practical Application
Animal Testing Ban, Requirements resulting from the Animal Testing Ban	Claims, Labelled Warnings and Instructions of Use	Borderline between Efficacy and Safety	The Cosmetic Product Safety Report – A practical Approach towards Format, Product Identification, Product Traceability, Completion	How to do a Safety Assessment (practical exercise with a example formula)
Quality of Testing Protocols	Results from Safety Assessment to be recognized in Labelling	Undesirable Effects and Serious Undesirable Effects	Assessor Credentials, Key Contents of Assessment, Conclusion and Reasoning	How to prepare a CPSR (practical exercise with a example formula)
GMP: Principles and Contribution to Product Safety	Functionality and Efficacy – Testing	Statistics	Responsibility Greyzones between Safety Assessor and Responsible Person	Proper documentation – how to prepare internal documents in order to be prepared for audits / challenges / inspections
LECTURER(S)	LECTURER(S)	LECTURER(S)	LECTURER(S)	LECTURER(S)
Markus Kleber Annemie Lambert	Alex van der Burgh	Mabel Iwobi Uwe Rossow	Uwe Rossow	Markus Kleber Annemie Lambert Alex van der Burgh Mabel Iwobi Uwe 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

.

Individual advice and feedback from the lecturers

Course Structure and Costs

Fee Structure: €1,400.00 per module

Booking Options: A complete course as starting in May 2021 or modules on their own

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 and 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: A certificate of attendance of the RWTH International Academy is issued upon termination of each module. The successful completion of a full course will be certified by Cosmetics Consultants Europe. Subsequently, a cosmetic product safety assessment can be performed. Provided the pre-condition of an available ‘diploma or other evidence of formal qualifications’ is fulfilled [acc. to Reg. (EC) 1223/2009, Art. 10 (2)], it can be signed as Safety Assessor under the EU’s regulatory scheme.

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

RWTH International Academy is the academy for continuing education of the German excellence university in, the RWTH Aachen University – www.cpsr-education.com/