Title: Composition
1Composition
- INCI - International Nomenclature of
Cosmetics Ingredients Nomenclature attributed
by the PCPC (ex CTFA) following certain rules - The EU and USA use the same nomenclature except
for the following substances
EU USA
Latin names e.g. aqua Trivial names e.g. water
Colour Index e.g. CI 14700 Colour Cosmetics e.g. Red N4
Linné nomenclature e.g. Triticum Vulgare Plants e.g. Wheat Germ Oil
2Composition
- In descending order of weight preceded by
INGREDIENTS not translated at time added - Concentrations lt 1 any order after
concentrations gt 1 - Colouring agents any order after other
ingredients - Parfum or Aroma not translated
- plus 26 potentially allergic perfume ingredients
if - gt 10 ppm for leave-on products
- gt 100 ppm for rinse-off products
- Range of decorative colorants /- CI (may
contain)
3Ingredients EU FIL Labelling
4Mixed Composition EU/ USA
- This is tolerated on the EU market
5Composition - Exemptions
- For certain substances
- Impurities in the raw materials used
- Subsidiary technical materials used in the
preparation but not present in the final product - Solvents for perfumes and aromatic compositions
6Where should this information appear
- All obligatory information must appear on the
container and the external packaging with the
exception of the ingredient composition which may
be indicated on the packaging alone - The information should be indelible and be in
characters which are visible and easy legible
7Product labellingPrimary / Secondary packaging
art. 6 .d et f
8Impossibility due to size and shape
- It is possible to indicate
- the precautions to be observed in use
- the composition
- by referring to a leaflet or attached card via a
phrase or by a symbol - Possible to indicate composition on a notice in
immediate proximity to the container in which the
cosmetic product is offered for sale - There is no definition of a small product
within the cosmetics directive
9Product labelling In case of small products
NoteSymbol not required when off-pack
labelling of ingredients
10Country of origin Made in
- Member States may require that the country of
origin be specified for goods manufactured
outside the Community - Article 6.1(a)
- Not obligatory for products manufactured and sold
within the EU (but if mentioned, this must not be
misleading) - Obligatory for import and export vis-à-vis the EU
- No recognition of Made in EU
11Country of origin Made in
12Obligations due to Horizontal Texts for Subjects
Outside the CD 76/768/EEC
- Aerosols (logo warnings)
-
- Environment (recycling logo green point)
13Principles of Safety Evaluation
14Principles of Safety Evaluation
- High level of consumer protection achieved
through a global and dynamic safety evaluation
and management approach - At individual consumer level
- Public/ collective level
15Safety Management
16Product Safety
- Article 2
- Article 7a(1)h Existing data on undesirable
effects on human health
A cosmetic product put on the market within the
Community must not cause damage to human health
when applied under normal or reasonably
foreseeable conditions of use, taking account, in
particular, of the products presentation, its
labelling, any instructions for its use and
disposal as well as any other indication or
information provided by the manufacturer or his
authorised agent or by any other person
responsible for placing the product on the
community market.
17Responsibilities of the safety assessor and
nature of the safety evaluation
18Safety Evaluation
- Proof of safety forms part of so called product
information - Safety for human health of finished product,
taking into consideration the general
toxicological profile of the ingredients, their
chemical structure and level of exposure (Article
7a) - Safety assessor must have adequate qualifications
and relevant experience - He/She may be a company employee or consultant,
not necessarily based in EU
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