Documente Academic
Documente Profesional
Documente Cultură
Reporting of Serious
Undesirable effects
Gerald Renner
Director Technical Regulatory Affairs
Cosmetics Europe
Undesirable effects to cosmetics
V Animal testing 18
VI Consumer information 19 - 21
IX Administrative cooperation 28 - 30
Who ?
Responsible Person (and Distributor)
What ?
All SUE cases , except those classified as “excluded”
Where ?
Country where serious undesirable effect occurred
When ?
Initial report : Without delay (understood as calendar 20 days)
Follow-up report : When new relevant information is obtained
How ?
Standardised SUE reporting forms, following EU Guidelines
Art. 2 : Definitions
• (o) «Undesirable effect» means an adverse
reaction for human health attributable to the
normal or reasonably foreseeable use of a
cosmetic product Causality assessment !
Note : the word "serious" is not synonymous with severe. "Severe" is used to
describe the intensity (severity) of the effect as in mild, moderate or severe.
Seriousness is used to describe the patient/event outcome or action.
• Article 10(1) & Annex I : Information to be
included in the Cosmetic Safety Report
– All available data on the UEs and SUEs to the
cosmetic product, or where relevant, other
cosmetic products
NO YES
Undesirable Undesirable
Event Effect
Not always so easy !
Suspected Undesirable Events
Rarely confirmed by relevant medical investigations
Often with consumer interpretation
Rarely only 1 product used
5 levels of causality :
Very Likely - Likely - Not clearly attributable - Unlikely - Excluded
Causality decision table
Symptomatology
Evocative Non evocative
Rechall. / Invest. Rechall. / Invest.
+ ? - + ? -
Chronology
Delay
between
exposure Not clearly
and Compatible L NCA UL NCA UL UL
reaction
onset
Symptoms
evocative
Chronology
Investigations
Rechallenge
Important considerations
Serious Case ?
Causality ?
CASE 1 - Narrative
Additional contact with mother and family doctor
• Identification of the product,
• Use history : Christmas gift, used intermittently for 2 months, 3 or 4
applications without problem
• Details about the reaction:
– occurred at home at 3 pm, a few minutes after applying the
product on the legs and hands.
– Reported: breathing problem, difficulty speaking, feeling of
sickness. Self-medication corticosteroids without effect.
– Called Hospital Mobile Intensive Care Unit who stated hypotension,
swollen face, abdominal pain.
• Hospitalisation in intensive care unit where she spent the night.
CASE 1 - Narrative
Additional information continued :
The mother does not know the treatment given, does not
have the report of hospitalization
Serious Case ?
Causality ?
CASE 1 - Narrative
New phone contact with the mother detailing the 2 hours preceding
the reaction :
Serious Case ?
Causality ?
Case Narrative N°2
• A phone call from an adult woman has been received on July 19, 2011, who
said :” On July 15, 2011, my daughter and I used the deodorant X and we
developed immediately a stinging feeling under the arms. One hour later, it
turned out as red spots. It was very visible as we both shaved our axilla on the
day before.”
• The product was correctly applied and previously used without any reaction.
Product was not used after July 15th.
Serious Case ?
Causality ?
Case Assessment N°3
Serious Case ?
Causality ?
Case Assessment N°3