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
1Market 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
2The 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
3In 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
4Inspection
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
5Laboratories 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
6RISK ASSESSMENT
From technical files (industrials data, studies
from litterature and lab controls)
AFSSaPS commission of cosmetology
Finish products
Ingredients
scientific opinions risk?
Decisions
7French 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
-
8Commission 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
10RELATIONS 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
11RELATIONS AFSSAPS EUROPETHE EUROPEAN COUNCIL
(STRASBOURG)
Resolutions Recommandations Guidelines
e.g Side effects
Experts Commitee for cosmetic Products
DGS, AFSSAPS, Industry
French Commission
National authorithies
12Examples 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
13Examples 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.
14Other 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.
15Examples 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.
16Examples 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.
17Advantages 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)
18Market 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 ?)
19Market 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.
20Market 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.