Activity Details

Course Objectives:

• Introduction of EU cosmetic Regulation, safety assessment and alternative methods
• Sharing hand-on experience on safety assessment and PIF preparation
• Introduction of GCC cosmetic regulation and recent development

Who should attend

This course is designed for specialists from NSBs, governmental agencies (Regulators and Market surveillance authorities), Conformity Assessment Bodies (Laboratories & other inspection and certification bodies),the cosmetic industry, the dermatologically oriented pharmaceutical industry, professionals in research and development, scientists, marketers and training people involved in dermato-cosmetics.

Course Content

GSO's four- day training proposal is a packaged training session covering all aspects of the cosmetics regulation and giving practical examples along each broached topic

Overview of the Cosmetics Regulation 1223/2009:

1.      Major practical and legislative changes between Directive 76/768/EEC and Regulation 1223/2009 (2h30)

• Major differences with the Directive 76/768
• Focus on the status and the responsibilities of the RP
• Focus on the CPNP notification
• Focus on labelling requirements
• Focus on claims and the 655/2013 Regulation: common criteria and substantiation

2.      Actors and instances of the cosmetic supply chain (30 min)

• European Commission / SCCS/ National authorities/ professional federations/ Responsible person
• Role and collaboration of the different actors

PIF requirements -Bordelineproducts issue

 1.      Product Information File for a finished cosmetic product according to the current Regulation 1223/2009 (2h)

• The five PIF sections
• Focus on mandatory data regarding the Raw Materials and Finished Products

2.      Borderline issues in context of cosmetics (1h)

• Borderline with toys
• Borderline with biocides
• Borderline with pharmaceuticals
• Borderline with medical devices

 Impact of REACH on cosmetic Industry -Packaging assessment

1. Impact of REACH on the cosmetic industry (1h)

• How does the REACH regulation impact a cosmetic product?
• Main obligations regarding registration
• Focus on ingredients registration
• Exemptions in REACH regulation

2. Packaging requirements under Annex I of Regulation 1223/2009 (2h)

• Regulations to consider
• Data exchanges -available templates-standard development
• Challenges observed

 Ingredients under EC spotlight and EU cosmetic challenges

1. Ingredients under the EC spotlight (1h)

• Preservatives
• Allergens
• Nano-materials and endocrine disruptors
• Hair-dyes

2. Current challenges in safety assessment of cosmetics in the EU (1h)

• Projects of regulation annexes modification
• Guidelines to manage CMR, aggregated exposures, traces of prohibited substances

3. Practical case 1: summary of achievements(1h)

• Use the knowledge acquired during the previous 2-day training.
• Exercise to summarize the regulatory requirements

 Toxicological data and testing of cosmetics

1.Roleoftolerancetestingplayedinthesafetyassessmentofcosmetics(2h)

• Management of skin and eye irritation potential, sensitization, photo toxicity/photosensitization
• Conventional testing methods and clinical tests available

2.Validated"and"valid"alternativemethods(actual use and tests)(1h)

• ECVAM methods validation process
• OECD validated alternative methods
• "Valid" alternative methods
• Further methods development of other toxicological endpoint: QRA approach

 Toxicological data and testing of cosmetics

1.Role of systemic toxicity testing played in the safety assessment of cosmetics(2h)

• Relevant choice of the key systemic toxicity descriptor: NOAEL(C)
• Calculation of the systemic Exposure Dose
• Valid Margins of Safety MoS
• New methodologies: Threshold Toxicological concept TTC

2.Genotoxicity and mutagenicity testing of cosmetics(1h)

• Definition and mechanisms of toxicity
• Conventional test methods and decision

 Specific toxicological assessments and market surveillance

1. Safety assessment of Nano-materials in cosmetic products (1h)

• Definition
• Challenge of the physic chemical characterization
• Nano-materials in the annexes of Regulation1223/2009

2. Safety assessment of natural ingredients (1h)

• Natural ingredients: a complex and undefined structure
• Identification of active substances
• Assessment of local toxicity

3. Market surveillance and notification of serious undesirable effects (1h)

• Definition undesirable effect (UE)/serious undesirable effect (SUE)
• Causality Assessment method
• Requirements for notification and transmission of SUEs
• Principles of interaction between the Responsible Person, Distributor and National Competent Authority

Practical case: makinga PIF(3h)

 Use the knowledge acquired during the training. The session can be organized into groups of 3-4 participants

• Identify the regulation applicable to a product and the requirements related to it
• Check the composition
• List the mandatory data regarding raw materials and products type
• Calculate margin of safety of ingredients

Day to day practice: interest of using cosmetic software

A long the four-day training: Experts from EcoMundo will deal with its own experience in EU cosmetics regulation to collect data, to keep a PIF up to date and to support safety assessment thanks to its software. Therefore, along the different topics, trainees will have the direct application of the theoretical speech in a day to day practice, in particular using cosmetics soft wares.

The Practical guide for  the cosmetic industry will be provided for each attendee.