CURRENT COSMETICS LEGISLATIVE FRAMEWORK IN CROATIA

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CURRENT COSMETICS LEGISLATIVE FRAMEWORK IN CROATIA

• Mr.sc.Vjera Haberle, dipl.ing
• CROATIAN NATIONAL INSTITUTE OF PUBLIC HEALTH
• Zagreb, studeni 2008

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Common use and general consumption items Law..

• Pursuant to the Croatian law, cosmetics belong
  to common use and general consumption items.
  Regulations on cosmetics are laid down in the Act
  on General Use Items (OG 85/06) and the Ordinance
  on General Consumption Items (OG 47/08). The
  latter gives one chapter to cosmetic products.

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Croatian Cosmetic Law

• Ordinance regulations primarily present a
  definition of a cosmetic product, as translated
  from the original definition in the Cosmetics
  Directive 76/768/EEC. Types of cosmetic products
  make up List I, the first Annex of the Ordinance.

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Croatian Cosmetic Law

• Next in line is a provision prescribing that no
  cosmetic product shall be damaging to human
  health immediately upon use, of for any longer
  period, in line with Article 2 of the Cosmetics
  Directive followed by a provision demanding that
  a cosmetic product shall be marketed solely in a
  packaging which makes proper application possible
  and protects product safety.

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Croatian Cosmetic Law

• Furthermore, there are requirements for
  marketing cosmetics, pursuant to Article 4 of the
  Directive, and a ban on testing cosmetics and raw
  materials on animals, including clauses when
  animal testing is permitted. It is also
  prohibited in the production of cosmetics to use
  substances which are, according to regulations on
  dangerous chemicals, divided as carcinogenic,
  mutagenic or toxic for reproduction into
  categories 1, 2 and 3.

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Croatian Cosmetic Law

• The Ordinance lists in detail everything a
  cosmetic product shall state on the label
  (information on product), in line with Article 6
  of the Directive. Consequently, manufacturer,
  importer or representative shall report to the
  competent ministry of health, in a form which is
  contained in the Ordinance, on the first or
  repeated marketing of a cosmetic product on the
  Croatian market.

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Croatian Cosmetic Law

• The Ordinance then lays down that the
  manufacturer, importer or representative shall
  provide the competent ministry of health with
  data on a particular cosmetic product, such as
  the ingredients, specifications on raw materials
  and end product, evaluation of safety for human
  health, as well as other data which make up
  product dossier.

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Croatian Cosmetic Law

• Likewise, pursuant to the Ordinance, the
  person responsible for marketing a cosmetic
  product shall, for the purposes of needed
  emergency medical actions, make available all
  corresponding information on the ingredients of
  the product to the Center for Poisoning Control.
  Such information shall only be used for necessary
  medical care.

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Croatian Cosmetic Law

• The Ordinance stipulates that the manufacturer
  of raw materials and active substances,
  intermediaries and end products shall, when
  requested, issue a BSE/TSE certificate regarding
  the applied raw materials. For fiber components,
  collagen and elastin, the importer shall deliver
  a manufacturer's certificate on BSE risk
  assessment adopted by a competent body in the
  country where the ingredient was produced.

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Croatian Cosmetic Law

• In continuance, the Ordinance lays down safety
  parameters for cosmetics, as follows HEAVY
  METALS in cleansing products and products for
  care of the teeth and the mouth, products for
  making up and coloring lips, products for making
  up and coloring the eyes and the remaining
  decorative cosmetics, with the exception of the
  cosmetics used for hair and nails followed by
  the criteria of MICROBIOLOGICAL CLEANNESS and pH
  VALUE of product, according to type of cosmetic
  product.

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Croatian Cosmetic Law

• The Ordinance also stipulates that
  professional cosmetics used in beauty salons
  shall be marketed as
• - products applicable solely by professionals
  and with a packaging that shall clearly state
  FOR PROFESSIONAL USE ONLY,
• - products for continued home care under the
  supervision of a professional, with a packaging
  that shall state TO BE USED UNDER PROFESSIONAL
  SUPERVISION.

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Croatian Cosmetic Law

• The Ordinance contains supplemented lists
  which correspond Annexes I, II, III, IV, VI and
  VII of the Cosmetics Directive, while Annex V of
  the Directive is included in the text of the
  Ordinance. Furthermore, there is a list of
  antioxidants, vitamins and vitaminoids, with a
  remark that, aside from those listed, other
  permitted raw materials from the same groups may
  be used, under the condition that they not affect
  product safety.

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Croatian Cosmetic Law

• Finally, the Ordinance also contains a
  supplement equivalent to Annex VIII of the
  Directive, as well as a supplement containing the
  sign corresponding to the PAO (Period After
  Opening) symbol in the Directive.