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 93285 Saint-Denis- France ? : 00 33 1 - PowerPoint PPT Presentation

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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 93285 Saint-Denis- France ? : 00 33 1

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AFSSaPS : commission of cosmetology. Ingredients. Finish products. scientific opinions : risk? ... on the basis of French commission of cosmetology conclusions. ... – PowerPoint PPT presentation

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Title: 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 93285 Saint-Denis- France ? : 00 33 1


1
Market surveillance of cosmetics products in
France advantages and shortcomings of the
directive Arila POCHET Head of the evaluatin
of cosmetic procducts department ?
Afssaps143/147 Boulevard Anatole France93285
Saint-Denis- France ? 00 33 1 55 87 42 43 03?
01 55 87 42 60? arila.pochet_at_afssaps.sante.fr

2
The market surveillance of cosmetics products in
France
The aims
To apply the regulation
Inspection Controls Evaluation (including
vigilance)
Approaches
To update the regulation
Consummers protection Public health
Finality
3
In France, several actors for the supervision
Regulation
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)
Lab Tests products
Afssaps (majority)

DGCCRF
Inspection
Afssaps, Inspectors from health ministery
DGCCRF
Evaluation (assessment of technical files)
Afssaps
4
Inspection
Distributors, retailers
compagnies
? manufacturers ? Importers (third countries)
gt2000 inspections per year
(DGCCRF) Afssaps and inspectors from the health
ministery
majority (DGCCRF)
Case by case
Specific issues
  • 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)
  • raw materials (animals derivatives)
  • Sunscreen products

5
Laboratories tests
Physico-chemical and microbiological tests,
safety trials (in vivo or in vitro) to test e.g
the tolerance or sensitivation
Afssaps beginning activity gt 100 controls in
2002
  • Specific survies
  • Solar products, whitening products in
    expecting
  • Babies cleaning products
  • Babies shampoos

Case by case following a notification of an
indesirable effect
If there is a risk
If relevant, inspection or policy décision
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
6
RISK ASSESSMENT
From technical files (industrials data, studies
from litterature and lab controls)
AFSSaPS commission of cosmetology
Finish products
Ingredients
scientific opinions risk?
Decisions
7
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

8
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
Minimal number of members Vote
Commission Approuving working groups others
subjects
OPINIONS
Decisions
9
File assessment
Information given by manufacturers and or
cosmetics Unions Information from Afssaps
(internal or Litterature) European documents
file
Competency, Prblems of financial
interests, confidentiality
Designation of an internal or external expert for
the file
Assessment
Chemical and/or , pharmaco-toxicological ,
clinical assessment .
Written Reports (s)
Discussions in the WG
Commission
Information to the Industry which can reply and
justify their point of vue
APPROUVED OPINIONS
Decisions
Policy Decision (emergency danger)
Guidelines to the manufacturers
Request to the European Commission (non urgent
case)
No risk
10
RELATIONS AFSSAPS EUROPETHE EUROPEAN
COMMISSION (BRUSSELS)
Directives to adapt the lists of substances to
the technical progress
Annexes of the Directive 76/768/CEE
SCCNFP
CAPT
SGCI (interministerial department)
DGS, AFSSAPS, DGCCRF, Industry
French Commission
National orders
NATIONAL AUTHORITHIES
EXPERTS
TEXTS
11
RELATIONS AFSSAPS EUROPETHE EUROPEAN COUNCIL
(STRASBOURG)
Resolutions Recommandations Guidelines
e.g Side effects
Experts Commitee for cosmetic Products
DGS, AFSSAPS, Industry
French Commission
National authorithies
12
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

13
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.

14
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.

15
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.

16
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.

17
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)

18
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 ?)

19
Market surveillance shortcomings of the
directive
  • 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.

20
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.
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