Market surveillance of cosmetics
products in France :
advantages and
shortcomings of the directive
Shampooing
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 42 43 03
 : 01 55 87 42 60
 : arila.pochet@afssaps.sante.fr
The market surveillance of cosmetics
products in France
The aims :
To apply the regulation
Approaches
Inspection
Controls
Evaluation (including
vigilance)
To update the regulation
Consummers protection
Finality
Public health
In France, several actors for the supervision
Regulation
implementation of the directives in the national rules
Health ministery (General Health Directorate : DGS) and Afssaps
policy decision
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
Inspection
Distributors, retailers
compagnies
 manufacturers
 Importers (third countries)
(DGCCRF)
Afssaps and inspectors from
>2000 inspections per
year
majority (DGCCRF)
the health ministery
Specific
issues
 raw materials (animals derivatives)
 Sunscreen products
Case by case
 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)
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 : > 100 controls in 2002
Specific survies :
 Solar products, whitening products : in
expecting
Case by case : following a
notification of an indesirable
effect
 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
If there is a risk
If relevant, inspection or
policy décision
RISK ASSESSMENT
From technical files (industrials data, studies from litterature and lab
controls)
AFSSaPS : commission of cosmetology
Finish products
Ingredients
scientific opinions : risk?
Decisions
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 »
WG « safety use «
Safety assessment
. Organization of cosmetovigilance
guidelines
. Assessment of indésirables effects
Safety use of products
GT « clinical trials »
. Protection of volunteers
Place authorizations for
trials
Minimal number
of members
Commission
Approuving working groups + others subjects
OPINIONS
Decisions
Vote
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
Chemical and/or ,
pharmacotoxicological , clinical
assessment .
Assessment
Written Reports (s)
Discussions in the WG
Information to the
Industry which can
reply and justify their
point of vue
Commission
APPROUVED OPINIONS
Decisions
No risk
Policy Decision
(emergency danger)
Request to the European
Commission
(non urgent case)
Guidelines to the
manufacturers
RELATIONS AFSSAPS – EUROPE
THE EUROPEAN COMMISSION (BRUSSELS)
SCCNFP
CAPT
SGCI
(interministerial
department)
French
Commission
EXPERTS
DGS, AFSSAPS,
DGCCRF, Industry
NATIONAL
AUTHORITHIES
Directives to
adapt the lists of
substances to the
technical
progress =
Annexes of the
Directive
76/768/CEE
National orders
TEXTS
RELATIONS AFSSAPS – EUROPE
THE EUROPEAN COUNCIL (STRASBOURG)
Experts
Commitee for cosmetic
Products
French
Commission
Resolutions
Recommandations
Guidelines
e.g : Side effects
DGS, AFSSAPS,
Industry
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
permanent hair dyes (diluted at 50% before application).
4% in
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 ?)
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.
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.