Composition

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Composition

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The EU and USA use the same nomenclature except for the ... Parfum ' or ' Aroma ' [not translated] plus 26 potentially allergic perfume ingredients if: ... – PowerPoint PPT presentation

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Title: Composition


1
Composition
  •  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
2
Composition
  • 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)

3
Ingredients EU FIL Labelling
4
Mixed Composition EU/ USA
  • This is tolerated on the EU market

5
Composition - 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

6
Where 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

7
Product labellingPrimary / Secondary packaging
art. 6 .d et f
8
Impossibility 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

9
Product labelling In case of small products
NoteSymbol not required when off-pack
labelling of ingredients
10
Country 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 

11
Country of origin  Made in  
12
Obligations due to Horizontal Texts for Subjects
Outside the CD 76/768/EEC
  • Aerosols (logo warnings)
  • Environment (recycling logo green point)

13
Principles of Safety Evaluation
14
Principles 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

15
Safety Management
16
Product 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.
17
Responsibilities of the safety assessor and
nature of the safety evaluation
18
Safety 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

19
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