Cosmetics Europe proposed strategy to ensure microbiological safety of cosmetic products

Transcription

1 Cosmetics Europe proposed strategy to ensure microbiological safety of cosmetic products Dr. Sylvie CUPFERMAN, Membre de l Expert Team Product Preservation, Cosmetics Europe, Directrice Internationale Microbiologie, L Oréal R&I 17 th November 2016

2 Overview of Presentation Outcomes of the Product Preservation workshops (Oct 2015 & Sept 2016) Key challenges & potential solutions with a focus on: Preservative usage & exposure assessment Improving the risk assessment process and paradigms Management of the risk using a holistic approach Maintenance & innovation Key messages 2

3 Outcomes from Product Preservation Workshops Crisis Point The Cosmetic Industry is facing a crisis with the continued loss/restriction of preservative ingredients. Preservative ingredients are being banned, product uses and/or use concentrations are being restricted at an alarming rate. Innovation pipeline of new preservative ingredients is virtually empty. Crisis Prevention needs A wide and diverse palette of suitable preservative ingredients. A risk management and risk assessment approach which brings together ingredient, product and consumer safety. A realistic consumer use & exposure modelling and assessments. A risk based approach to ensure consumer safety. Improved dialogue and collaboration between experts. 3

4 Inadequate preservation - a consumer health issue Protect products against growth of microorganisms introduced during continued use and maintain product quality and safety: - Without preservatives, possible development of bacteria, yeast, mould and other organisms Product deterioration, spoilage and potential health and safety issues - Microbia contamination can potentially cause significant health problems Since 01/2014, 190 RAPEX notifications and withdrawal of contaminated cosmetic products from the market and 33 are considered due to microbiological risk «Weekly overview reports of RAPEX notifications» European Union,

5 Reality Check 3 November 2016 Review of the EU Annex V preservatives banned, restricted (Annex V reference number/date of JOCE publication) + those about to be banned and under EUCOM/SCCS evaluation BANNED RESTRICTED ABOUT TO BE BANNED/RESTRICTED EU COM / SCCS EVALUATION PENDING Hexachlorophene (ex N 6/1987) Propyl + Butylparaben (N 12/2014) Sodium iodate (ex N 10/2007) Triclosan (N 25/2014) Isoparabens, benzylparaben, phenylparaben, pentylparaben (ex N 12/2014) MDBGN (ex N 36/2007) MCIT/MIT (Kathon CG/N 39/2014) Iodo Propynyl Butyl Carbamate (N 56/2007) Formaldehyde (N 5) Mercury containing preservatives: Thiomersal (N 16) Phenyl mercuric salts (N 17) Quaternium 15 (N 31) Chloroacetamide (N 41) Methylisothiazolinone (N 57) O-Phenyl phenol & salts (N 7) Zinc pyrithione (N 8) Formaldehyde Releasers: Bronidox, Bronopol, Imidazolidinyl urea, Methenamine, DMDM Hydantoin, Diazolidinyl urea, Sodium hydroxymethyl glycinate, Benzyl hemiformal (N 20, 21, 27, 30, 33, 46, 51, 55) PHMB (N 28) Climbazole (N 32) 4/59 4/59 6/59 12/59

6 Key Challenges & Solutions Risk Assessment- Exposure and Usage Current Status Current exposure assessment scenarios overestimated since it assumes : Daily consumers use all product types on a daily basis (17.4g). All product types contain the same preservative ingredient. Preservatives are added at the maximum authorized concentration. Vision Future exposure scenarios reflect: Real consumer practices (all cosmetic products not used at the same time). More realistic up to date exposure scenarios using improved exposure assessment tools (probabilistic approach). Presence probability data & realistic use concentration. Updated information could extend knowledge for SCCS and Industry to assist with risk and exposure assessments. Acceptance and use of exposure modelling. 6

7 Probabilistic Approach: Aggregate Exposure Model AAAAAA EEEEEE = FFFFFFFFFFFFFFFFFF AAAAAAAAAAAA RRRRRRRRRRRRRRRRRR CCCCCCCCCCCCCCCCCCCCCCCCCC PPPPPPPPPPPPPPPPPPPPPP BBBBBBBBBBBBBBBBBBB 7

8 Key challenges & Potential Solutions Current Status Risk Assessment - Methodologies Preservative safety is important across several industries. Vision Formal collaboration between EU COM experts on key safety issues and methodologies. Lack of new preservatives added to Annex V driven by lack of acceptance or availabilities of new approaches. Systemic toxicity endpoints assessments: No accepted non-animal alternative methods available. Need for advocating more of weight of evidence approach. EU COM commitment and support to maintain a wide and diverse preservative ingredient palette. Next generation risk assessment approaches accepted to assure the safety of preservative ingredients (new and existing). Weight of evidence approaches consistently applied. 8

9 Key challenges & Potential Solutions Current Status Reactive state with preservatives being lost one by one. Risk Management Vision Clear EU strategy on PP with key milestones and deliverables. Focus on ingredient safety. No pre-meeting with SCCS prior to submission to discuss deliverables. No impact assessment when preservatives are restricted or banned. Achieving right balance: ingredient safety AND product safety = consumer safety. Critical for dialogue between EU COM and industry prior to submission as part of a systematic approach. Introduce a health impact assessment to identify implications to certain product types. 9

10 Key Messages To maintain a wide and diverse palette of cosmetic preservative ingredients we need to: 1. Refine the exposure scenarios to reflect realistic consumer use and exposure- probabilistic exposure. 2. Gain acceptance of the next generation risk assessment approachesto include weight of evidence. 3. Combine ingredient safety and finished product microbial safety to deliver consumer safety. 4. Introduce a health impact assessment of the preservative ingredient palette prior to restriction or ban of a specific preservative ingredient. 5. Encourage innovation of new preservative ingredients 10