PIF Introduction Including Safety Assessment Cosmetics Information Day, September 15 th 2010 Dr. Sarah O Meara, Pre-clinical Assessor, Irish Medicines Board The content of this presentation does not purport to be an interpretation of law and/or regulations and is for guidance purposesslide only. 1
Legislation & Guidance EU legislation: Cosmetic Directive 76/768/EEC, as amended S.I. No. 870 of 2004 Cosmetic Products Regulation (EC) No 1223/2009 (recast) EU Guidance: The SCCP s notes of guidance for the testing of cosmetic ingredients and their safety evaluation, 6th revision. Date 15/09/2010 Slide 2
Objective To introduce the Product Information File (PIF) and outline key data required To give guidance on the safety assessment requirements for cosmetic products Date 15/09/2010 Slide 3
PIF Requirements Directive 76/768/EEC, Article 7a; SI 870 of 2004, Reg 12 The Responsible Person (RP) shall keep the following information readily accessible to the competent authorities of the Member State concerned at the address specified on the label Must be available in the national language of the Member State concerned Date 22/03/2010 Slide 4
Contents of PIF Qualitative & Quantitative composition Physico-chemical & microbiological specifications of raw materials and finished product Method of manufacture complying with GMP Assessment of the safety for human health of finished product Data on undesirable effects Proof of the effect claimed Date 22/03/2010 Slide 5
Safety Assessment Key element a cosmetic product must not cause damage to human health taking account the product s presentation, its labelling, any instructions for its use Directive 76/768/EEC, Article 2 The RP shall keep an assessment of the safety for human health of the finished product, taking into account (for the ingredients) the toxicological profile the level of exposure special exposures children, mucous membranes the chemical structure Directive 76/768/EEC, Article 7a 1(d) Shall be carried out in accordance with the principles of GLP Directive 76/768/EEC, Article 7a (2) Date 15/09/2010 Slide 6
Safety Assessor Name & Address in PIF Must hold at least a diploma in the field of pharmacy, toxicology, dermatology, medicine or similar discipline Does not need to be an employee of the organisation can be independent/ external to the organisation Date 22/03/2010 Slide 7
Safety Assessment of Cosmetics Date 22/03/2010 Slide 8
Safety Assessment Process Hazard identification Testing, clinical studies, literature Dose-response assessment What concentrations, thresholds do the effects occur Exposure assessment How long, how often is the exposure? Any sensitive groups? Risk characterisation What are the chances that adverse effects will occur? Determination of Margin of Safety (MoS 100) MoS = NOAEL/SED Date 15/09/2010 Slide 9
Toxicity Hazard identification Acute toxicity (oral, dermal, inhalation)* Irritation (skin, eye)* Skin sensitisation* Trans-dermal (percutaneous) absorption Repeated-dose toxicity studies Mutagenicity/genotoxicity* Carcinogenicity Reproductive toxicity Toxicokinetics Photo-induced toxicity (for UV absorbing molecules) Any human data *Minimum studies for safety evaluation by assessor Studies must be done to GLP Date 15/09/2010 Slide 10
Animal Testing Directive 76/768/EEC Art 4a Testing ban For finished cosmetic products since 2004 For ingredients, when alternative validated, latest 2009 Marketing ban Finished product or ingredients tested on animals after validated method, latest 2009, except for repeated-dose toxicity, reproductive toxicity, toxicokinetics, latest 2013 Draft Report on Alternative (non-animal) methods for cosmetics testing: current status and future prospects - 2010 deadline for comments 15 th Oct 2010 Date 15/09/2010 Slide 11
Regulation (EC) No 1223/2009 - recast RP shall ensure the cosmetic product has undergone a safety assessment and that a cosmetic product safety report is set up in accordance with Annex I Regulation 1223/2009 Article 10, para 1 RP shall ensure the intended use and anticipated systemic exposure to individual ingredients are taken into account Commission shall adopt appropriate guidelines to enable compliance with the requirements in Annex I Date 15/09/2010 Slide 12
In Summary RP obligation to maintain PIF and demonstrate the safety of all cosmetic products on the market Contains data necessary to demonstrate compliance with the legislative requirements Must be kept up-to-date Readily accessible at the address specified on the label Date 22/03/2010 Slide 13
Thank You for your attention! Date 22/03/2010 Slide 14