Presentation on theme: "Arila POCHET Head of the evaluatin of cosmetic procducts department Afssaps 143/147 Boulevard Anatole France 93285 Saint-Denis- France : 00 33 1 55 87."— Presentation transcript:
Arila POCHET Head of the evaluatin of cosmetic procducts department Afssaps 143/147 Boulevard Anatole France Saint-Denis- France : : : Market surveillance of cosmetics products in France : advantages and shortcomings of the directive Arila POCHET Head of the evaluatin of cosmetic procducts department Afssaps 143/147 Boulevard Anatole France Saint-Denis- France : : : Shampooing
The aims : To apply the regulation The market surveillance of cosmetics products in France Inspection Controls Evaluation (including vigilance) To update the regulation Consummers protection Public health Approaches Finality
of the directives in the national rulespolicy decision implementation of the directives in the national rules policy decision Health ministery (General Health Directorate : DGS) and Afssaps Afssaps Economy Ministery : Trade and Fraud Repression Directorate and Industry Directorate (DGCCRF) In France, several actors for the supervision Regulation Lab Tests products Inspection Evaluation (assessment of technical files) Afssaps (majority) Afssaps, Inspectors from health ministery Afssaps DGCCRF
compagnies Distributors, retailers manufacturers manufacturers Importers (third countries) Importers (third countries) >2000 inspections per year Specific issues Case by case raw materials (animals derivatives) Sunscreen products following the notification of an undesirable effect in order to check the information included in the technical file in order to control the animal trials (GLP) and clinical trials quality production (GMP) (DGCCRF) Afssaps and inspectors from Afssaps and inspectors from the health ministery Inspection majority (DGCCRF)
Physico-chemical and microbiological tests, safety trials (in vivo or in vitro) to test e.g the tolerance or sensitivation Afssaps : beginning activity : > 100 controls in 2002 Specific survies Specific survies : Solar products, whitening products : in expecting Babies cleaning products Babies shampoos No riskThere is a risk : meeting with industry to justifie or change things Decisions; modification of the formulation, market stopping, modification of the labelling Case by case Case by case : following a notification of an indesirable effect If there is a risk If relevant, inspection or policy décision Laboratories tests
From technical files (industrials data, studies from litterature and lab controls) AFSSaPS : commission of cosmetology Ingredients Finish products scientific opinions : risk? Decisions RISK ASSESSMENT
French commission of cosmetic products 4 members of administration (Afssaps, Health ministery, Directorate of trade and fraud repression and directorate of Industry), 17 scientific experts, 6 scientific people who are working in the Cosmetic Industry, A chairman and vice-chairman choosed between its experts members. a representative from the consumers association
Commission of cosmetic products : working groups preparing the opinions of the Commission WG « ingredients » GT « clinical trials » WG « safety use « Safety assessment guidelines. Organization of cosmetovigilance. Assessment of indésirables effects Safety use of products. Protection of volunteers Place authorizations for trials Commission Approuving working groups + others subjects OPINIONS Decisions Minimal number of members Vote
File assessment File assessment Designation of an internal or external expert for the file Assessment Written Reports (s) Discussions in the WG Commission Decisions Competency, Prblems of financial interests, confidentiality Information given by manufacturers and or cosmetics Unions Information from Afssaps (internal or Litterature) European documents Chemical and/or, pharmaco- toxicological, clinical assessment. file APPROUVED OPINIONS Policy Decision (emergency danger) Guidelines to the manufacturers Request to the European Commission (non urgent case) No risk Information to the Industry which can reply and justify their point of vue
RELATIONS AFSSAPS – EUROPE THE EUROPEAN COMMISSION (BRUSSELS) Directives to adapt the lists of substances to the technical progress = Annexes of the Directive 76/768/CEE SCCNFP DGS, AFSSAPS, DGCCRF, Industry French Commission NATIONAL AUTHORITHIES CAPT SGCI (interministerial department) National orders EXPERTSTEXTS
RELATIONS AFSSAPS – EUROPE THE EUROPEAN COUNCIL (STRASBOURG) Resolutions Recommandations Guidelines e.g : Side effects Experts Commitee for cosmetic Products DGS, AFSSAPS, Industry French Commission National authorithies
Examples of assessment Ingredients : glycol ethers in cosmetic products. 7 have been banned because of their reprotoxic effect 4 which are still been used have been assessed phénoxyethanol : the current regulation is confirmed. EGBE : limitation is proposed at 9% for the use in hair dyes only DEGBE: limitation is proposed in hair dyes at 2% or 4% in permanent hair dyes (diluted at 50% before application). DEGEE : the assessment is engoing to a limitation or a ban proposal
Examples of assessment Ingredients : new substances used in cosmetic products. The competent authority in France for classification of chemical substances regularly asked Afssaps for a risk assessment for the consumer in order to complete the risk assessment for environment and for the workers Some difficulties : the data are often inadequate for a relevant evaluation and a administrative cooperation between member- states is needed. A guideline to inform about the minimum tests for a cosmetic ingredient could be helpful.
Other examples for ingredients Tooth whitening containing hydrogeen peroxide : assessment of the recent litterature : F involved in the proposal of a compromise for a draft directive on the basis of French commission of cosmetology conclusions. UV filters : proposal for the European Commission about a strategy in order to reassess the most widely used filters.
Examples of risk assessment for finish products Notification of serious indesirable effects : 12 cases of sensitisation with vit K1 products Withdrawal of the products from the market. Product with essential oils containing terpens (camphor and eucalyptol) used for babies : Risk assessment in favour of a toxic effect because of a concentration in eucalyptol three times over the tempory TDI given by the Concil of Europe. In addition, one undesirable effect (neurological troubles). The product has been withdrawn even from the retaillers. 7 undesirables effects have been notified since the date of the withdrawal of the product.
Examples of controls Products contained not intentionnaly some traces of products : Phthalates for example Difficulties : to define what is a trace ? What is the minimum of level for traces ? Products which are microbiologically contaminated : GMP and methods are needed (ISO or UE ?), specific criteria from the scientific committee. Products with misleading labels and in particular for the safety : for examples shampoos with a claim of « very gentle product for babies eyes» and the tests shows a significant eye irritation.
Advantages of a market surveillance Strictly necessary because : - there is no authorization before putting a product on the market - products are widely used every day by the entire population (old people, adults, teenagers, children and babies) Strictly necessary in order to : - check if the regulation is applied in terms of composition and labelling, dossier and so on when the directive is accurate. - to update the lists as often as possible and as soon as possible to avoid potential harmful products considering long term effects (e.g cancers)
Market surveillance : shortcomings of the directive Cosmetovigilance : A sytem implemented by each authority or by the commission is needed to complete the market surveillance. F has implemented in its regulation a national obligation for the halth professional : to notifie to the competent authority the serious undesirable effects. Such a system should be discussed in order to oblige the industrials to notifie their undesirable effects (8th amendment ?)
Access to the formula of the products for the competent authorities. To evaluate the risk of a specific substance, the authorities should be able to know how many products are involved and at what concentration. But in the directive, there is only a possibilty in case of troubles to have adequate information (what does « adequate » excatly mean ?) For France, only the poison center have the formula of the products which is not readily accessible to Afssaps. Market surveillance : shortcomings of the directive
Clinicals trials. The directive is relevant for the product put on the market. What about the product used in clinicals trials ? In France, there is a system of authorization for product with a potential risk or using volunteers with deseases or using methodologies which present a risk. Market surveillance : shortcomings of the directive