Cosmetics

A “cosmetic product” is defined as any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours. 

Production and marketing of cosmetic products in Iceland must comply with the requirements of Icelandic regulation of cosmetic products No 577/2013 that implements Regulation of the European Commission on cosmetic products No. 1223/2009 into Icelandic law. Also, this regulation demands producers and importers of cosmetic products into the EEA to demonstrate the safety of products and to report adverse effects of products. A responsible person shall stand for each cosmetic product placed on the market. 

The Environment Agency of Iceland is the competent authority for the cosmetic regulation and the marketing of cosmetics in Iceland.

Production of cosmetics 

  • Production of cosmetics is subject to license from the local health inspectorate. Prior to placing product on the market within the EEA it shall be notified into the CPNP of EU

Marketing of cosmetics 

  • Prior to placing a cosmetic product on the market, it shall be ensured that it contains only substances approved within the EEA and fulfils requirements of labelling (see Appendixes II-VI and Article 19 of the EC regulation of cosmetic products). 
  • Prior to placing a cosmetic product on the market within the EEA it shall be notified into the CPNP of EU

A responsible person shall stand for all cosmetic products placed on the market, which guarantees that the product meets the requirements of regulations. The responsible person can be a:

  • Producer of the cosmetic product within the EEA or his agent, 
  • Importer of the product from countries outside the EEA or his agent or 
  • Distributor when marketing a product already on the market in his own name or brand or making changes the product. 

The responsible person needs to have the following data:

  • Product information file that includes:
    • Description of the cosmetic product. 
    • Cosmetic product safety report. See Guidelines about safety report. 
    • Description of the method of manufacturing and a statement on compliance with good manufacturing practice.
    • Proof of effect claimed for the cosmetic product. See Guidelines of common criteria for the justification of claims used in relation to cosmetic products.
    • Safety assessment for the cosmetic product.

The responsible person shall make the product information file readily accessible to the competent authority of the Member State in which the file is kept.

Labelling of cosmetic products shall be in Icelandic, English or Nordic language other than Finnish. However, certain labelling concerning conditions of use and warnings shall be in Icelandic. Following information shall be included on a label or a leaflet:

  • Name of the cosmetic product. 
  • Function of the cosmetic product, unless it is clear from its presentation. 
  • Name and address of the responsible person.
  • Country of origin of the cosmetic product if imported into the EEA. 
  • Nominal content at the time of packaging (weight or volume). 
  • Date of minimum durability. 
  • Wordings of conditions of use and warnings in Icelandic according to Icelandic translation of Annexes III.-VI. of the EC regulation of cosmetic products. 
  • Batch number of manufacture.
  • List of ingredients (INCI name or other approved nomenclature). All nanomaterials shall be specified. Perfume and aromatics shall be referred to by the terms “perfume” or “aroma”. 

 

 See more information of labelling of cosmetic products in Article 19 of the EC Regulation of cosmetic products.

Before a cosmetic product is placed on the market it shall be ensured that it contains only substances approved within the EEA.

  • Substances listed in Annex II of the EC regulation are prohibited in cosmetic products. 
  • Substances listed in Annex III of the EC regulation are subject for restrictions.
  • In Annexes IV-VI of the EC regulation allowed colorants, preservatives and UV filters are listed. 

 

On the CosIng website of the European Commission can be checked if a certain substance is approved in cosmetic products, prohibited or if there are some rules or restrictions on the substance. The substance name is written in the search window on the site and then information about it will appear with reference to Annex of the EC regulation on cosmetic products. 

CPNP - Cosmetic Products Notification Portal 

Prior to placing a cosmetic product on the marked in the EEA the responsible person or his/hers agent shall notify the product into the CPNP of EU. The following information shall be notified: 

 

General information 

  • Category and the products name. 
  • Name and address of the responsible person. 
  • Country of origin in the case of import into the EEA.
  • The country within the EEA in which the product is to be placed on market. 
  • Photographs of the cosmetic product/packaging. 
  • Photographs of labels or of text on the packaging. 

Chemical information

  • Predefined frame formulation, exact concentration or concentration ranges of substances in the product. 
  • Information of CAS or EC number of substances classified as carcinogenic, mutagenic or toxic (CMR) if present in the product. 
  • Information of substances in the form of nanomaterials if present in the product. 

 

See user manual for notifications in CPNP and further information of the notification in Article 13 of the EC regulation. 

RAPEX is the EU rapid alert system that facilitates the rapid exchange of information between EU states and the European Commission on measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers. The product may need to be withdrawn from the market, recalled from consumers or warnings are needed. 

According to Article 5 of the Icelandic chemical Act, No. 61/2013, the Environment Agency of Iceland plays the role of notifying products and viewing notification of products in RAPEX. The Agency regularly prepares a list of illegal cosmetic products in RAPEX, focusing on products originated from neighbouring countries in Europe, USA, Canada and China, or have been banned in these countries. The agency publishes the lists on the website and sends to the main importers of cosmetic products in Iceland, thus promoting non-health and even illegal cosmetics in the market in Iceland.

If cosmetic products on the list turn out to be on the Icelandic market it is requested that it is notified to the Environment Agency of Iceland through this web page or by the e-mail to ust@ust.is.

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