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
Register: cpsr@academy.rwth-aachen.de
Enter Code: e-training 2021
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
FAQs
With Brexit a ‘done deal’, can I use the course for cosmetics assessment under UK law?
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?
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/