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Cosmetic products definition EU


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This presentation shows which products are considered to be cosmetic products in the EU and which conditions they need to fulfill to be considered cosmetics.

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Cosmetic products definition EU

  1. 1. EU REGULATION 1223/2009© CE.way Regulatory Consultants Ltd
  2. 2. LEGISLATION• EU cosmetic regulation 1223/2009 (replacing directive 76/768/EC)• Applicable: July 2013 onwards© CE.way Regulatory Consultants Ltd
  3. 3. COSMETIC PRODUCT DEFINITION“‘cosmetic product’ means any substance ormixture intended to be placed in contact withthe external parts of the human body(epidermis, hair system, nails, lips and externalgenital organs) or with the teeth and themucous membranes of the oral cavity with aview exclusively or mainly to cleaning them,perfuming them, changing their appearance,protecting them, keeping them in goodcondition or correcting body odours;” (Regulation 1223/2009, Article 2.1a)© CE.way Regulatory Consultants Ltd
  4. 4. COSMETIC PRODUCTSThis definition applies to all cosmetic products,be they• Sold in shops• Through vending machines• By mail order• Via the internet• Applied by professionals• Made available in hotels, spas etc.© CE.way Regulatory Consultants Ltd
  5. 5. COSMETIC PRODUCTS CATEGORIESCosmetic products may include (regulation 1223/2009)• Creams• Emulsions• Lotions• Gels and oils for the skin• Face masks• Tinted bases (liquids, pastes, powders)• Make-up powders• After-bath powders• Hygienic powders• Toilet soaps• Deodorant soaps© CE.way Regulatory Consultants Ltd
  6. 6. COSMETIC PRODUCTS CATEGORIES• Perfumes• Bath and shower preparations (salts, foams, oils, gels)• Toilet waters and eau de Cologne• Depilatories• Deodorants and anti-perspirants• Hair colorants• Hair-setting products• Products for waving, straightening and fixing hair• Hair-cleansing products (lotions, powders, shampoos)• Hair-conditioning products (lotions, creams, oils)• Hairdressing products (lotions, lacquers, brilliantines)© CE.way Regulatory Consultants Ltd
  7. 7. COSMETIC PRODUCTS CATEGORIES• Shaving products (creams, foams, lotions)• Make-up and products removing make-up• Products intended for application to the lips• Products for care of the teeth and the mouth• Products for nail care and make-up• Products for external intimate hygiene• Sunbathing products• Products for tanning without sun• Skin-whitening products• Anti-wrinkle products© CE.way Regulatory Consultants Ltd
  8. 8. COSMETIC PRODUCTS CATEGORIES – CPNP Level 1 Level 2 Skin care products Skin cleansing products Body and hair removal products Bleach for body removal products Correction of body odour and/or perspiration Skin products Shaving and pre- /after-shaving products Make-up products Perfumes Sun and self-tanning products Other skin products© CE.way Regulatory Consultants Ltd
  9. 9. COSMETIC PRODUCTS CATEGORIES – CPNP Level 1 Level 2 Hair and scalp care and cleansing products Hair and scalp Hair colouring products products Hair styling products Other hair and scalp products Nail varnish and remover products Nail and cuticle Nail care / nail hardener products products Nail glue remover products Other nail and cuticle products Tooth care products Oral hygiene Mouth wash / breath spray products Tooth whiteners Other oral hygiene products© CE.way Regulatory Consultants Ltd
  10. 10. COSMETIC PRODUCTS• Presentation of a cosmetic product (in particular its form, odour, colour, appearance, packaging, labelling, volume or size) should not endanger health and safety of consumers due to confusion with foodstuffs• Products containing substances or preparations intended to be ingested, inhaled, injected or implanted into the human body do not fall under the definition of cosmetics© CE.way Regulatory Consultants Ltd
  11. 11. COSMETIC PRODUCTS• Cosmetic products should conform with the requirements regarding prohibited ingredients, restricted substances, colorants, preservatives and UV filters (these can be found in the regulation Annexes II-VI)© CE.way Regulatory Consultants Ltd
  12. 12. COSMETIC PRODUCT CLAIMSProduct claims are very important when itcomes to product classification• Should be in line with the definition of the cosmetic product• Cosmetic products should therefore not claim, for example, that they treat any kinds of diseases© CE.way Regulatory Consultants Ltd
  13. 13. BORDERLINE PRODUCTS• Products where it might be difficult to classify them into one or the other product category  Cosmetic/pharmaceutical product borderline  Cosmetic/biocide borderline  Cosmetic/medical device borderline  Etc.• Case-by-case© CE.way Regulatory Consultants Ltd
  14. 14. ALWAYS REMEMBERThe assessment of whether a product is acosmetic product has to be made on thebasis of a case-by-case assessment, taking intoaccount all characteristics of the product!© CE.way Regulatory Consultants Ltd
  15. 15.© CE.way Regulatory Consultants Ltd