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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

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

Members of Regulatory Authorities

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

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

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
Raphael Sauerwein Alex van der Burgh Patrick Gonry Patrick Gonry ALL

Module 2: Toxicology 1

ONLINE SEMINAR DATES
1 2 3 4 ATTENDANCE DAY ONLINE
n/a n/a n/a n/a n/a
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
n/a n/a n/a n/a n/a

Module 3: Toxicology 2

ONLINE SEMINAR DATES
1 2 3 4 ATTENDANCE DAY ONLINE
n/a n/a n/a n/a n/a
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
n/a n/a n/a n/a n/a

Module 4: Exposure Criteria / Safety Margins

ONLINE SEMINAR DATES
1 2 3 4 ATTENDANCE DAY
n/a n/a n/a n/a n/a
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
n/a n/a n/a n/a n/a

Module 5: Packaging, Stability, Microbiology

ONLINE SEMINAR DATES
1 2 3 4 ATTENDANCE DAY
n/a n/a n/a n/a n/a
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
n/a n/a n/a n/a n/a

Module 6: Cosmetic Products Evaluation

ONLINE SEMINAR DATES
1 2 3 4 ATTENDANCE DAY
n/a n/a n/a n/a n/a
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)
n/a n/a n/a n/a n/a

Who we are?

RWTH International Academy

RWTH International Academy is the academy for continuing education of the German excellence university RWTH Aachen University.

Cosmetics Consultants Europe (CCE)

Cosmetics Consultants Europe (CCE) is a pan-European industry association uniting consultant working in the cosmetics, cosmetic ingredients and borderline industries. The majority of CCE’s members are located in the Member States of the European Union; others are based in Brazil, China, Colombia, Israel, Russia, Switzerland, Turkey, UK & USA. The services provided include Regulatory Affairs, Safety Assessment, Testing, Formulation, IT, Marketing, Quality Assurance, Training, etc.

Why us?

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

  • Continously updated state of the art knowledge of science and regulatory affairs

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

  • Individual advice and feedback from the lecturers

What our participants say

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 and Covid-safe

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

  • Predictability: modules will be offered on firmly fixed dates

  • 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

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.

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.

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.

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.

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