Market surveillance of cosmetics products in France :

advantages and shortcomings of the directive

Arila POCHET Arila POCHET Head of the evaluatin of cosmetic procducts Head of the evaluatin of cosmetic procducts

department department Afssaps Afssaps

143/147 Boulevard Anatole France143/147 Boulevard Anatole France93285 Saint-Denis- France 93285 Saint-Denis- France : 00 33 1 55 87 42 43 03 : 00 33 1 55 87 42 43 03

: 01 55 87 42 60 : 01 55 87 42 60 : arila.pochet@afssaps.sante.fr : arila.pochet@afssaps.sante.fr

Shampooing

The aims :

To apply the regulation

The market surveillance of cosmetics The market surveillance of cosmetics products in Franceproducts in France

Inspection

Controls

Evaluation (including vigilance)

To update the regulation

Consummers protection

Public health

Approaches

Finality

implementation of the directives in the national rules of the directives in the national rules policy decision 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 supervisionIn France, several actors for the supervision

RegulationRegulation

Lab Tests productsLab Tests products

InspectionInspection

Evaluation Evaluation

(assessment of technical files)(assessment of technical files)

Afssaps (majority)

Afssaps, Inspectors from health ministery

Afssaps

DGCCRF

DGCCRF

compagnies Distributors, retailers

manufacturersmanufacturers

Importers (third countries)Importers (third countries)

>2000 inspections per year

Specific Specific

issuesissues

Case by caseCase 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 trialsquality production (GMP)

(DGCCRF)(DGCCRF)

Afssaps and inspectors from Afssaps and inspectors from

the health ministerythe health ministery

InspectionInspection

majority (DGCCRF)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 surviesSpecific survies :

Solar products, whitening products : in expecting

Babies cleaning products

Babies shampoos

No risk There is a risk : meeting with industry to justifie or change

things

Decisions; modification of the formulation, market stopping, modification of the labelling

Case by caseCase by case : following a notification of an indesirable

effect

If there is a risk

If relevant, inspection or

policy décision

Laboratories testsLaboratories tests

From technical files (industrials data, studies from litterature and lab From technical files (industrials data, studies from litterature and lab controls)controls)

AFSSaPS : commission of cosmetology

Ingredients Ingredients Finish productsFinish products

scientific opinions : risk?

Decisions

RISK ASSESSMENTRISK ASSESSMENT

French commission of cosmetic productsFrench 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 Commission of cosmetic products : working groups preparing the opinions of the Commissionpreparing the opinions of the Commission

WG « ingredients » GT « clinical trials »WG « safety use « 

Safety assessment

guidelines

. Organization of cosmetovigilance

. Assessment of indésirables effectsSafety use of products

. Protection of volunteersPlace authorizations for trials

Commission

Approuving working groups + others subjects

OPINIONS

Decisions

Minimal number of members

Vote

File assessmentFile 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 – EUROPRELATIONS AFSSAPS – EUROPEE

THE EUROPEAN COMMISSION (BRUSSELS) THE EUROPEAN COMMISSION (BRUSSELS)

Directives to Directives to adapt the lists of adapt the lists of substances to the substances to the

technical technical progress = progress = Annexes of the Annexes of the

Directive Directive 76/768/CEE76/768/CEE

SCCNFPSCCNFP

DGS, AFSSAPS, DGS, AFSSAPS, DGCCRF, IndustryDGCCRF, Industry

French French CommissionCommission

NATIONAL NATIONAL AUTHORITHIESAUTHORITHIES

CAPTCAPT

SGCISGCI

(interministerial (interministerial department) department)

National ordersNational orders

EXPERTSEXPERTS TEXTSTEXTS

RELATIONS AFSSAPS – EUROPERELATIONS AFSSAPS – EUROPE

THE EUROPEAN COUNCIL (STRASBOURG) THE EUROPEAN COUNCIL (STRASBOURG)

Resolutions Resolutions Recommandations Recommandations

Guidelines Guidelines e.g : Side effects e.g : Side effects

ExpertsExperts

Commitee for cosmetic Commitee for cosmetic ProductsProducts

DGS, AFSSAPS, DGS, AFSSAPS, IndustryIndustryFrench French

Commission Commission

National National authorithiesauthorithies

Examples of assessmentExamples 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 assessmentExamples 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 ingredientsOther 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 productsExamples 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 controlsExamples 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 surveillanceAdvantages 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 directiveMarket 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 Market surveillance : shortcomings of the directivedirective

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 Market surveillance : shortcomings of the directivedirective