Cosmetics

What is meant by being a responsible person of a cosmetic product?
A responsible person may be a producer within the European Economic Area (EEA), an importer of the product from countries outside the EEA or a distributor when marketing a product already on the market in his own name or brand or making changes on the product.
The reponsible person must guarantee that the cosmetic product on the market meets the requirements of regulations on cosmetic products, i.a. regarding notification into the Cosmetic Products Notification Portal (CPNP) and having a product information file and a safety assessment for each product.
Is there a need for a permit to import cosmetics to Iceland?
No, but the products must meet the requirements of national Regulation No 577/2013 on cosmetic products which implements Regulation (EC) No 1223/2009 on the same subject as the product is placed on the market for the first time. These are requirements regarding the labelling, ingredients and the notification of the product in the CPNP by the responsible person. Detailed information can be found on the website of the Environmental Agency in Icelandic and English.
All cosmetics producers in Iceland must notify their cosmetics in the CPNP before they are marketed. Furthermore, a cosmetic product must be notified into CPNP when it is imported for the first time into the EEA. The same goes for a cosmetic product that a distributor places on the market under his or her name or brand or changes a product already on the market within the EEA. The distributor then becomes the responsible person for the product in question.
What are the requirements for cosmetic labelling?
The labelling is discussed in detail in Article 3 of national Regulation No 577/2013 and Article 19 Regulation (EC) No 1223/2009. A compilation of mandatory labelling is also available on our website.
Which substances are forbidden to use in cosmetics?
In Annex II of the Regulation (EC) No 1223/2009 on cosmetics there is a list of substances that are prohibited in cosmetic products within the EEA.
What requirements must be met when manufacturing cosmetics in Iceland?
Production of cosmetics is subject to license from the local health inspectorate. Furthermore, the production and marketing of cosmetic products in Iceland must comply with the requirements as described above.
Here are the basics that a producer / responsible person for a cosmetic product needs to have in mind when placing it on the market within the EEA:
- Notify the product electronically in the CPNP (Cosmetic Products Notification Portal) before it is placed on the market.
- Make sure that the product only contains ingredients which are allowed to be used in cosmetics. Prohibited cosmetic ingredients are listed in Annex II in the Cosmetics regulation.
- Make sure that the product complies with chemical content restrictions listed in the Annexes of the Cosmetics regulation.
- Have in its possession a product information file containing a safety report and a product safety assessment.
- Take care that the production complies with good manufacturing practices. The standard for good manufacturing practices can be obtained from the Icelandic Standard Council but also online
- Make sure that the packaging of the cosmetic product is labelled in accordance with Article 3 of national Regulation No 577/2013, as well as Article 19 of the Cosmetics Regulation (EC) No 1223/2009.
- All ingredients should be listed according to the global cosmetic nomenclature system, INCI.
- No claims regarding a drug action or a healing power may be asserted on the packaging. In such cases, the product falls under the Icelandic Medicines Agency and must be classified and marketed as a drug.
  
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What is needed when marketing cosmetics manufactured in another EEA state, e.g. Paris, France?
There is no special permit needed in Iceland when marketing cosmetic products from another country. As Iceland is within the EEA the above mentioned requirements must be fulfilled and that is the responsibility of the manufacturer in France.
What on the other hand should be taken into consideration when marketing cosmetic products that are produced in countries like France is the language requirement, which is, according to the national Regulation No 577/2013 on cosmetics, that they are labelled in Icelandic, English or Nordic language other than Finnish. If labelling is not in any of these languages, their marketing in our country is not allowed. There is also a requirement that the conditions of use and warnings according to column i. in Annexes III, V and VI of the Regulation (EC) No 1223/2009 shall be in Icelandic. This goes first and foremost for products containing certain ingredients which may potentially cause health damage.
What are the rules apply on safety assessment for cosmetics?
Article 10 in the Cosmetics regulation depicts the rules that apply on safety assessment for cosmetics and Annex I describes how a cosmetic product safety report should be set up.
It should be pointed out that the safety assessment is a part of the so-called a product information file, that a responsible person, also needs to prepare or have made prepared for the product.
According to Article 10 in the Cosmetics regulation is it conditional that a safety assessment „shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State".
What can be done to evaluate if a product imported from a country outside the EEA is allowed for marketing in the area?
The name or registered name and address of the responsible person within the EEA is one of the elements that must be included in the labelling of the packaging of cosmetics products placed on the market in the area. It is therefore advisable to check whether that information is in place, because, if it isn’t, it indicates that the product is not legal on the market. Such information may be abbreviated in so far as the abbreviation makes it possible to identify that person and his address.
An importer may also request confirmation from a foreign supplier of the product, which shows that it is already registered in the EU cosmetics web portal, CPNP, which is a prerequisite for the product being eligible for the European market.
Who is responsible for creating a “Certificate of Free Sales” in Iceland?

No provisions or requirements for such documents or their making are stated in the laws or regulations on cosmetics.

The Icelandic Chamber of Commerce (Viðskiptaráð Íslands) issues “Certificate of Free Sales” for cosmetics at a request.