Safety & Efficacy of Cosmetics New rules of the European Commission Nicola Lionetti ISPE srl
L. Rigano Industrial Consulting & Research ISPE – Instit...
Safety & Efficacy of Cosmetics New rules of the European Commission Nicola Lionetti ISPE srl
L. Rigano Industrial Consulting & Research ISPE – Institute of Skin Product Evaluation
Regulation (EC) 1223/2009 of the European Parliament and of the Council of the 30 November 2009 on cosmetic products (recast) http://eur‐lex.europa.eu/LexUriServ/LexUriServ.do? uri=OJ:L:2009:342:0059:0209:en:PDF
Entry into force & date of application 11 January 2010 (20 d publication Official Journal) Only for CMR ⇒ 1 December 2010 New Notification ⇒ 11 January 2012 Nanomaterial ⇒ 11 January 2012 11 July 2013
Regulation 1223/2009 Mainly a RECAST Clarification/Explication on: Responsible Person (RP) Good Manufacturing Practice (GMP) Supply Chain & Market Surveillance Safety of the Cosmetics Proof of the effect claimed
Regulation 1223/2009 New rules on: Cosmetic Notification (CPNP) Nanomaterials (def. & Notification) CMR Label Indications Underline the PIF address
Titanium Dioxide (nano)
Regulation 1223/2009 Improves
FREE CIRCULATION SAFETY CLAIM of COSMETICS
Safety Assessment
Little Digression
Clarification/Explication ? Safety of the Cosmetics Article 7a, paragraph d (Directive 76/768) Assessment of the safety for human health of the finished product. To that end the manufacturer shall take into consideration the general toxicological profile of the ingredients, their chemical structure and their level of exposure. It shall take particular account of the specific exposure characteristics of the areas on which the product will be applied or of the population for which it is intended. There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene SCCNFP/0690/03, Final : Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation, 5th revision, adopted by the SCCNFP during the 25th plenary meeting of 20 October 2003
Safety Report Art. 11 – Product Information File shall contain: ‐ …….. ‐ cosmetic product safety report (CSR) Art. 10 – CSR: ‐ guaranteed by RP ‐ kept up to date ‐ carried out by qualified person (pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by Member State)
Safety Report Art. 10 – CSR: ‐ The Commission, in close cooperation with all stakeholders, shall adopt appropriate guidelines to enable undertakings, in particular small and medium‐sized enterprises, to comply with the requirements laid down in Annex I.
Annex I COSMETIC PRODUCT SAFETY REPORT The cosmetic product safety report shall, as a minimum, contain the following PART A – Cosmetic product safety information PART B – Cosmetic product safety assessment
RISK ASSESSMENT
Annex I PART A – Cosmetic product safety information 1. Quantitative & qualitative composition cosmetic product 2. Physical/chemical characteristics & stability 3. Microbiological quality 4. Impurities, traces, information on packaging material 5. Normal & reasonably foreseeable use
Annex I PART A – Cosmetic product safety information 6. Exposure to the cosmetic product 7. Exposure to the substances 8. Toxicological profile of the substances 9. Undesirable effects & serious undesirable effects 10. Information on the cosmetic product
Annex I PART B – Cosmetic product safety assessment 1. Assessment conclusion 2. Labelled warnings and instructions of use 3. Reasoning 4. Assessor’s credentials and approval of part B
Annex I PART A – Cosmetic product safety information 1. Quantitative & qualitative composition cosmetic product 2. Physical/chemical characteristics & stability 3. Microbiological quality 4. Impurities, traces, information on packaging material 5. Normal & reasonably foreseeable use
Annex I 4. Impurities, traces, information about the packaging material 4.1 The purity of the substances and mixtures 4.2 In the case of traces of prohibited substances, evidence for their technical unavoidability 4.3 The relevant characteristics of packaging material, in particular purity and stability
Guidelines on Annex I COMMISSION IMPLEMENTING DECISION of XXX on Guidelines on Annex I to Regulation (EC) No 1223/2009 on cosmetic products http://ec.europa.eu/enterprise/tbt/tbt_reposito ry/EEC186_EN_2_1.pdf
Guidelines on Annex I 4.3 The relevant characteristics of packaging material, in particular purity and stability • Direct contact with the formulation • Reference to Regulation on Food Contact Materials
(migration) • Experience with similar formulation/packaging • Interaction between product and packaging material • Barrier properties of packaging material • Composition of the packaging material (+ additives) • Technically unavoidable impurities
Example Eyeshadow powder pressed in pan tin plate containing in plastic container Safety/Technical Sheets Plastic container: Acrylonitrile Butadiene Styrene (ABS) polymers > 98% Styrene