Recherche et Preservatives & Cosmetic Micro Regulations in the EU ylvie CUPFERMAN, Ph D Or October 2010 Recherche et Presentation Outline 1. Preservatives on the EU positive list a. New preservatives b. Preservatives under review 2. The New European Cosmetic Regulation Or 1
Recherche et 1.a. New Preservatives Ethyl auroyl Arginate 57 th Adaptation Cosmetic Directive (2010/3 February 2010): Annex III = 0.8% soap, anti-dandruff shampoo, deodorant (non aerosol) Annex VI = 0.4% except lips, oral hygiene and aerosols Entry in application ept. 2010 (products in the hands of the consumer: March 2011). New CCP mandate to evaluate the supplier data related to oral hygiene and lip products as EA is approved as food additive. Or Recherche et Citric acid (and) ilver Nitrate Industry request : 0.2% 1 st CCP opinion Jan. 2009: insufficient data. 2 nd CCP opinion Oct. 2009: OK 0.2%, except oral hygiene and eye products but recommendation to evaluate the global exposition (argyriose). Discussed during AHWP Feb. 2010: OK at 0.0024% (expressed in silver). urvey on the other uses in progress (EU Commission). Or 2
Recherche et 1.b. Preservatives under review Methylisothiazolinone / Methylchloroisothiazolinone (Kathon CG ) Industry request: 0.0015% in rinse-off products only. CCP opinion Dec. 2009: OK 15 ppm in rinse-off but caution with sensitization risk. Industry (Dow & Thor) have sent comments on this opinion New CCP opinion pending. Or Recherche et Zinc pyrithione Industry request: 2 % anti-dandruff shampoo (specific use / annex III) CCP opinion pending (new mandate April, 2009) Parabens Industry request : 0.4% (acid) per ester / 0.8% for blends CCP opinion pending for Propyl & Butyl et Iso forms (discussed during the plenary meeting eptember, 2010) [OK for Methyl & Ethyl (2005 et 2008)] Polyaminopropyl Biguanide (Cosmocil CQ ) Proposition of CMR 3 classification made by France (Afsset) to ECHA. upplier (Arch Chemical) + COIPA collaboration to try to avoid this classification. Or 3
Recherche et Quaternium-15 (Dowicil 200) Dangerous ubstances Directive : CMR3 classification of the «cis» isomer. CCP mandate (March 2010) on the Industry safety dossier Chloracetamide Dangerous ubstances Directive : CMR3 classification. Call for data from the EU Commission Formaldehyde & releasers Dossier submitted by the Industry: waiting for a CC mandate Reach : France dossier for CMR 1a or 1b Or Recherche et The New European Cosmetics Regulation (EC 1223/09) Or 4
Direction Internationale Evaluation écurit Presentation Outline Introduction Timeline What remains the same What changes Conclusion Or Direction Internationale Evaluation écurit Why change? European Cosmetics Directive: 76/768 EEC 30 years old - 7 modifications and 44 adaptations Each modification requires a very long, complex process -> extremely obstructive Required recast and simplification Or 5
Direction Internationale Evaluation écurit The recast process Recast and simplification project: January - March 2007: public survey April - December 2007: multi-party discussions involving Commission-Industry-COIPA 2008: Parliamentary work on the recast project 24 March 2009: Vote on the New Regulation by the European Parliament Or Direction Internationale Evaluation écurit Timeline 2009 2010 2011 2012 2013 NR Vote (24-Mar-09) Entry into force (11-Jan-10) Notification (11-Jan-12) Entry into application (11-July-13) Publication OJ of the EU (22-Dec-09) Nanomaterials notification (11-Jan-13) Or 6
Direction Internationale Evaluation écurit New Regulation Chapter Title Articles I cope, definitions 1-2 II afety, responsible person, free movement 3-9 III afety Assessment, product information file, sampling and analysis, notification 10-13 IV Restrictions for certain substances 14-17 V Animal testing 18 VI Consumer information 19-21 VII Market surveillance 22-24 VIII Non-compliance, safeguard clause 25-27 IX Administrative cooperation 28-30 X Implementing measures, final provisions 31-40 ANNEXE I - X Or Direction Internationale Evaluation écurit New Regulation What remains the same Broad def n of a cosmetic product Market surveillance (no prior authorisation) One person responsible for market introduction Principle of safety pecific regulations for certain ingredients (annexes) Ban on animal testing Traces of prohibited substances Or What changes Regulation vs. Directive Added definitions Notification obligation Nanomaterials afety Report Claims erious undesirable effects Expanded distributor obligations Improved market surveillance Modification of the regulation of CMR chemicals INCI Glossary 7
Direction Internationale Evaluation écurit What remains the same Or Direction Internationale Evaluation écurit Cosmetic Product Definition Article 2: Any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to: cleaning them perfuming them changing their appearance protecting them keeping them in good condition correcting body odours Or 8
Direction Internationale Evaluation écurit Principle of safety Article 3: A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking into account, in particular, the following: a) Presentation, including conformity with Directive 87/357/EEC b) abelling c) Instructions for use and disposal d) Any other indication or information provided by the responsible person defined in Article 4. The presence of such indications however does not exempt persons from compliance with the other requirements laid down in this Regulation. Or Direction Internationale Evaluation écurit Ban on animal testing Article 18: Ban on: Performing tests on animals in the EU For finished products (11 eptember 2004) For ingredients or combinations of ingredients (11 March 2009) Ban on: The placing on the market of cosmetic products where the final formulation or ingredients/combinations of ingredients, in order to meet the requirements of this Regulation, have been the subject of animal testing (11 March 2009) Exception made for repeated-dose toxicity, reproductive toxicity and toxicokinetic testing (11 March 2013) Or 9
Direction Internationale Evaluation écurit ubstances listed in the Annexes Article 14: Annex II: Prohibited substances Annex III: ubstances subject to restrictions Annex IV: Colorants (plan to add hair dyes to this list) Annex V: Preservatives Annex VI: UV-Filters Modification of the numbering: Application only on 11 July 2013 Or Direction Internationale Evaluation écurit Traces of prohibited substances Article 17: Non-intended presence mall quantity of a prohibited substance temming from: impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging. Technically unavoidable in good manufacturing practice Permitted provided that the product is safe for human health Or 10
Direction Internationale Evaluation écurit What changes Or Direction Internationale Evaluation écurit Regulation vs. Directive Directive: Transposition into local legislation (± local specificities) Transposition deadlines Regulation: Directly applicable as is in the 27 member countries No differences from country to country Or 11
Direction Internationale Evaluation écurit Added definitions Article 2: Cosmetic Product ubstance Mixture Manufacturer Distributor End user Making available on the market Placing on the market Importer Harmonised standard Nanomaterial Preservatives Colorants UV-Filters Undesirable effect erious undesirable effect Withdrawal Recall Frame formulation Or Direction Internationale Evaluation écurit Notification Article 13: Prior to placing the product on the market: Category of cosmetic product Name(s) enabling its specific identification Name and address of the responsible person Country of origin (in the case of import) Member tate in which the cosmetic product is to be placed on the market Contact details of a physical person Presence of substances in the form of nanomaterials Identification Exposure conditions CMR 1A or 1B (name and CA number) Frame formulation Or 12
Direction Internationale Evaluation écurit Notification Article 13: Notification when placing the product on the market: Original labelling Photograph of the corresponding packaging (where reasonably legible) Notification: Possible to start notification as of 11 January 2012 Mandatory as of 11 July 2013 (for all of the products on the market on this date) Or Direction Internationale Evaluation écurit Nanomaterials - Definition Article 2: Definition (Art. 2): nanomaterial means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm Or 13
Direction Internationale Evaluation écurit Nanomaterials - Pre-notification Article 16: Mandatory pre-notification for nanomaterials: Notification 6 months prior to being placed on the market Unless the nanomaterials used are colorants, UVfilters or preservatives and are listed in the annexes Electronic notification: Identification, specification, toxicological profile, safety data, exposure conditions, quantity Or Direction Internationale Evaluation écurit Nanomaterials - Pre-notification Article 16: The Commission / CC has a period of 6 months to provide an opinion (period can be prolonged if data is missing) Pre-notification of nanomaterials can start as of 11 January 2013 Article 19 (labelling): Ingredient INCI name followed by [nano] Or 14
Direction Internationale Evaluation écurit afety Assessment Article 10: Product safety report updated for all cosmetic products on the market on 11 July 2013 Annex I: Content of the cosmetic product safety report Or Direction Internationale Evaluation écurit afety Assessment Part A afety information Quantitative and qualitative composition Physical/chemical characteristics and stability Microbiological quality Impurities, traces, information about the packaging material Normal and reasonably foreseeable use Exposure to the cosmetic product Exposure to the substances Toxicological profile of the substances Undesirable effects and serious undesirable effects Information on the cosmetic product Part B afety Assessment Assessment conclusion abelled warnings and instructions of use Reasoning Assessor's credentials Or 15
Direction Internationale Evaluation écurit afety Assessment Cosmetic Product afety Report Part A - Cosmetic Part B - Cosmetic Product afety Information Product afety Assessment ❷Physical/ chemical ❶Quantitative & qualitative characteristics and stability ❶Assessment conclusion composition of the product of the cosmetic product ❹Impurities,traces,information ❷abeled warnings and ❸Microbiological quality about the packaging material instructions of use ❺Normal and reasonably foreseeable use ❻Exposure to the cosmetic product ❸Reasoning ❼Exposure to the substance ❽ Toxicological profile ❹Assessor of Assessor s s credential the substances and approval of part B ❾ Undesirable effects and ❿Information on the serious undesirable effects cosmetic product Or Direction Internationale Evaluation écurit Annex I Cosmetic product safety report The cosmetic product safety report shall, as a minimum, contain the following: PART A Cosmetic product safety information 3. Microbiological quality The microbiological specifications of the substance or mixture and the cosmetic product. Particular attention shall be paid to cosmetics used around the eyes, on mucous membranes in general, on damaged skin, on children under three years of age, on elderly people and persons showing compromised immune responses. Results of preservation challenge test. Or 16
Direction Internationale Evaluation écurit Claims Article 20: Do not attribute characteristics or functions to cosmetic products when they do not have them The Commission shall, in cooperation with Member tates, establish an action plan regarding the claims used and fix priorities for determining the common criteria that justify the use of claims The Commission shall take appropriate measures By 11 July 2016, the Commission shall submit a report regarding the use of claims on the basis of the common criteria The Commission adopts the necessary measures Or Direction Internationale Evaluation écurit Communication of serious undesirable effects Definition: An undesirable effect (an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product) which results in Temporary or permanent functional incapacity Disability Hospitalisation Congenital anomalies An immediate vital risk Death Or New EU Cosmetics Regulation Date 44 17
Direction Internationale Evaluation écurit Communication of serious undesirable effects Article 23: The responsible person or the distributor shall without delay notify the Competent Authority of the Member tate where the serious undesirable effect occurred This Competent Authority shall immediately transmit this information to the competent authorities of the other Member tates. If the notification is received by the distributor or an end/professional user, the Competent Authority shall inform the responsible person Or New EU Cosmetics Regulation Date 45 Direction Internationale Evaluation écurit Identification within the supply chain Article 7: At the request of a competent authority: responsible persons shall identify the distributors to whom they supply the cosmetic product The distributor shall identify the distributor or the responsible person from whom, and the distributors to whom, the cosmetic product was supplied. This obligation shall apply for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor. Or New EU Cosmetics Regulation Date 48 18
Direction Internationale Evaluation écurit ubstances classified as CMR substances Article 15: Possibility (exceptional) of authorisation for CMR 1A and 1B substances (currently prohibited): If they comply with the food safety requirements If there are no suitable alternatives available For a particular use with a known exposure If they have received a favourable CC opinion Re-evaluated every 5 years Or New EU Cosmetics Regulation Date 49 Direction Internationale Evaluation écurit Conclusion - Discussion Or 19