Living with the Regulation from a SME perspective

Living with the Regulation
from a SME perspective
Dr Catherine Renard,
Chief Executive Officer,
Quatre S Cosmetics
Cosmetic Market in EU
• 505 millions habitants with 28 countries
• A unique regulation 1223/2009
• Bigger than US market
– But a non competitive market
• Barrier of languages
• Labor cost :
– Manufacturing cost
– Expertise cost
Where cosmetics sold in EU are
manufactured?
Non competitiveness
• Cosmetics Consumption low in EU
– Small brand, small batches (ie 5 000 units is the
minimum)
• Sold between 1 to 10 € exluded VAT (excluded perfume
case) ie 5000 € to 50 000 €
– How could you amortized the cost of regulation ?
– The production of small quantity is not anymore possible.
» Dying market?
European Directive vs Regulation
1223/2009
• Big changes
• Notification: (especially for French company)
• Definition of responsibility (not so clear)
• Distributor implementation in the product safety and
traceability
• Question mark on the level of application,
understanding and implication in the different
countries of Europe
– Conclusion: still unclear definition because in the
real world there is many different type of
companies.
Notification
Responsibilities
– A distributor can be also a retailer and an
importing company can also be a distributor.
– A non EU brand can have a responsible person
established within the Community. If this non EU
brand is imported in EU by another EU company
which distributes the product inside the EU ?
Added value
• Time consuming changes with minor impact in term
of safety
• Safety assessment (PartB)
– SED calculation
– MOS mainly based on NOAEL determinated by oral absorption
– ISO standard (Chinese manufacturing company vs French
manufacturing company)
• Relation with suppliers to provide the right information
to ensure a good safety evaluation, mainly toxicological
data but also packaging component information.
Claims
• Efficacy and claims: claims must be
documented and proved depending of the
level of claims made.
– Might be closer to the Canadian or Australian
claim list. Increase price for SME.
Animals testing
• Discordance between Reach and Cosmetic
regulation.
• Problem of recognition with some countries
(China)
Cosmetics : Common Goods?
• Cosmetic vs Pharmacy it seems
– regulation is more demanding for cosmetics as
regards to stability or pollution control.
PAO and its determination
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no body understand what mean such logo?
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Google : PAO
Catégorie:Logiciel de PAO — Wikipédia
fr.wikipedia.org/wiki/Catégorie:Logiciel_de_PAO
Un logiciel de PAO est destiné à permettre la création d'ouvrages imprimés tels que livres,
brochures ou catalogues. Article détaillé : Publication assistée par ...
Pão de queijo — Wikipédia
fr.wikipedia.org/wiki/Pão_de_queijo
Les plus utilisés sont la mozzarella, le parmesan, mais plus traditionnellement le fromage de
l'État de Minas. Le fromage donne le goût typique de Pão de queijo ...
Images correspondant à PAOSignaler des images inappropriées
Plus d'images pour PAO
Pao Production - Accueil
www.paoproduction.nc/
Pao Production. ... spacer.png, 0 kB, Installation et habillage par PAO Production d'après un
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de as the necessity to open the jar or the bottle.
Allergy
• Very often the claim hypoallergenic with
allergens labelled in the IL…
• Monitoring side effect is necessary but with a
cross analysis (contact dermatitis but also
food or medecine).
– Importance of cosmetivigilance : interaction
between medical treatment and cosmetic
application (BHT, small peptides)
Innovation
• Without innovation, non competiveness in EU
– Putting in the EU market new active ingredient
only used in cosmetic industry is an economic non
sense
Too many regulation kill the product and market
behind the product
Future for SME’s