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Cosmetovigilance and

Reporting of Serious
Undesirable effects

Gerald Renner
Director Technical Regulatory Affairs
Cosmetics Europe
Undesirable effects to cosmetics

• EU Cosmetics Regulation requires products “to


be safe” BUT this does not mean “zero risk”
• Small proportion of consumers will inevitably
experience undesirable effects
• Products are still considered safe if the rate /
nature of the undesirable effects remain
wirhin acceptable limit
• Same issue independent of regulatory
apporach (pre-market approval or in-marker
control)
Undesirable effects to cosmetics
(UE)
UE from normal use of cosmetics are generally :
– local (itching/ burning, irritation, allergic skin
reaction)
– transient
– succesfully addressed by patient self-
management without medical intervention
Undesirable effects to cosmetics

• Vast majority of cases do not result in medical


consultation
• Very rarely, more serious effects may occur
• Undesirable effects per se do not mean that
the products are unsafe.
• Concerns arise if the type or frequency of
reactions create a safety signal

 role of cosmetovigilance is to make such


safety signals visible
Objective of Cosmetovigilance

Support post marketing surveillance by companies


and authorities

• Add information to the post marketing safety


evaluation a given product
• Contribute to the decision making process for risk
management

Safety Signal Generation :


• Detect unexpected changes of reporting rates
(number and/or nature of UEs) compared to an
existing baseline
EU Approach on Cosmetovigilance
Main source of information is industry
• Logical and nearest contact point for EU consumers – especially n
case of non-serious undesirable effects.
• Data can be easily collected on individual products and be compared
between similar products
• Industry standards can be devleopped for handling and assessing
UEs, thus allowing data to be comparable across the industry

Priority is given to serious undesirable effects


• Non-serious cases need to be recorded as summary information in
the product information file
• Serious cases need to be actively reported to the authorities
Cosmetovigilance Elements in the EU
Cosmetics Regulation 1223/2009/EEC

Chapter Title Articles

I Scope, definitions 1-2

II Safety, responsible person, free movement 3-9

III Safety Assessment, product information file, 10 - 13


sampling and analysis, notification

IV Restrictions for certain substances 14 - 17

V Animal testing 18

VI Consumer information 19 - 21

VII Market surveillance 22 - 24

VIII Non-compliance, safeguard clause 25 - 27

IX Administrative cooperation 28 - 30

X Implementing measures, final provisions 31 - 40


ANNEXES I-X
In a nutshell :

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 !

• (p) «Serious undesirable effect» means an


undesirable effect which results in temporary or
permanent functional incapacity, disability,
hospitalization, congenital anomalies, or an
immediate vital risk or death

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

• Article 21: Access to information for the public


– …existing data on UEs and SUEs , attributable
to the products
Article 23: Communication of SUEs
In the event of SUEs, the responsible person and distributors
shall without delay notify the following to the competent
authority of the Member State where the SUE occurred:
• All SUEs which are known to him or which may
reasonably be expected to be known to him;
• The name of the cosmetic product concerned,
enabling its specific identification
• The corrective measures taken by him, if any
When distributors, end users, Professionals of Health report
serious undesirable effects to the competent Authority (…), this
competent authority shall immediately transmit the information
(….) to the responsible person
European Commission Guidance on
reporting of Serious Undesirable Effects
European Commission, with Member States and Industry has
developed guidance and template report forms based on EU Cosmetics
Regulation :

• Causality Assessment method


• Scope of notification of SUEs
• Requirements for notification and transmission of SUEs
• Principles of interaction between the Responsible Person,
Distributor and National Competent Authority
• Subsequent actions by Responsible Person and Competent Authority
Pilot studies with industry are ongoing
Causality Assessment

Suspected undesirable event

Is there a causal relationship with the reported product ?

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

 The case information is often not easily assessed as YES


(Very Likely) or NO (Excluded)

 If not easy : need to avoid subjective evaluation


Development of a
Causality Assessment
Method with intermediate
levels of relatedness.

This method is included in the EU


Commission Guidelines on SUE
reporting
Objective of the method.

 Consistent and reproducible analysis/evaluation of


reported cases
Between Companies
Inside the Company
With all stakeholders (e.g. authorities)
 To estimate the degree of relation between the use of a
cosmetic product and the development of an undesirable
effect
 For each individual case report
Principle of the method.

 Analysis of 3 key parameters


 Symptoms : Semiology
 Time sequence of event(s) : Chronology
 Specific medical investigation(s) and/or
Re-exposure to the product: rechallenge

5 levels of causality :
Very Likely - Likely - Not clearly attributable - Unlikely - Excluded
Causality decision table

Symptomatology
Evocative Non evocative
Rechall. / Invest. Rechall. / Invest.
+ ? - + ? -
Chronology

Compatible VL L NCA L NCA UL

Delay
between
exposure Not clearly
and Compatible L NCA UL NCA UL UL
reaction
onset

Incompatible Excl Excl Excl Excl Excl Excl


Causality decision tree

Symptoms
evocative

Chronology

Investigations

Rechallenge
Important considerations

 Assessment of individual cases


 Assessment possible only if enough information is
available
 Assessor must have appropriate background and
training in undesirable event assessment
 Whenever appropriate, support of a medical expert
should be sought
 Assessment can change when new information is
collected
CASE 1 - Narrative
Phone call from the mother of a 16 years old
consumer.
Reports that her daughter has had an anaphylactic
shock the day before, following the use of a body
lotion.
Her daughter is still hospitalized in an intensive care
unit

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 :

Relevant medical history :


– Known allergic background, confirmed latex allergy . Food
allergies (banana, kiwi, avocado).
– Food/ exercise induced allergy. Emergency kit available at
home
– No previous problem with cosmetic products

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 :

• Regular meals between 1 and 2 pm


• Between 2: 00 pm and 3: 30 p.m. fitness, ate some chocolate
• Application of the body lotion on the hands and legs at about 3:
30 p.m.
• 3: 30 pm manipulated a latex balloon,
• 3: 43 itching hands, then breathing problem, eyes pruritus.
• 4: 00 pm called her mother

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.

• The reaction disappeared spontaneously within 15 minutes for the stinging


sensation and a few hours fort he red spots.

• No medical investigations were performed.


Case Assessment N°2
• There are two case reports. Both are valid.

• It is not a serious undesirable effect.


• The symptoms could be in relation with the application of a deodorant for
several reasons :
– their nature,
– their localization,
– Even if shaving axilla may be partly responsible, the reactions were
not observed before applying the deodorant AND it may be
reasonably expected for a deodorant to be applied on shaved axillae.
• The chronology of events is compatible for both events.
• Causality assessment :
– Symptomatology: evocative
– Chronology: Compatible Likely related
– Re-exposure/investigations: ?
Case Narrative N°3

• A 17-year old man experienced severe itching and rash on the


scalp after the first and single use of a hair styling product.
• The reaction worsened over the next 2 weeks. A
dermatologist was consulted and a medicated shampoo was
prescribed. The patient used the medication only twice and
than discontinued because he felt that the product didn’t suit
him. The reactions temporarily improved but recurred 2
months later. The outcome of the reactions is unknown.

Serious Case ?
Causality ?
Case Assessment N°3

• Medical history obtained from treating doctor : already


experienced these symptoms several times in the past, but he
never consulted a dermatologist until now
• Medical consultation: yes
• Final diagnosis: seborrheic dermatitis

Serious Case ?
Causality ?
Case Assessment N°3

• The case is valid and is non serious.

• Symptoms are evocative

• Chronology is not clearly compatible (persistance of symptoms 2 weeks


after discontinuation, reoccurance without re-exposure)

• History indicates an underlying disease which can explain the reported


symptom. Medical investigation is needed which was not possible in this
case.

• The case is not clearly attributable (or excluded).

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