Chemicals

Legislation and authorisations for chemicals in Iceland

The Environment Agency is the competent authority for the application of a number of EU acts. That includes

  • Regulation (EC) No. 1907/2006 (REACH)
  • Regulation (EC) No. 1272/2008 (CLP)
  • Regulation (EU) No. 528/2012 (biocides)
  • Regulation (EC) No. 1107/2009 (plant protection products)
  • Regulation (EC) No. 1223/2009 (cosmetics) 
  • Directive 2011/65/EU (RoHS)

See detailed information in tabs above.

The Environment Agency is responsible for the helpdesk for REACH and CLP. Manufacturers, importers, exporters, distributors, downstream users and others should be able to get key information regarding the chemicals legislation in Iceland on this webpage.

Contact us by email: ust@ust.is, by phone: +354 5912000 or by fax: +354 5912010.

The Poison Information Center is responsible for storing information on emergency response. Contact by email: eitur@landspitali.is or telephone: +354 5432222.

REACH

The REACH regulation applies in Iceland. No further requirements on registrations, authorisations or restrictions are required. The Environment Agency participates in enforcement projects and in ECHA working groups. Safety data sheets shall be available to professional users in Icelandic. Requirements for the compilation of safety data sheets shall be according to regulation (EU) no. 453/2010 after it will enter into force in 2012.

CLP

The classification and labelling of substances and preparations applies to Icelandic Regulation No. 415/2014 on the classification, labelling and packaging of substances and preparations, based on the CLP Regulation No. 1272/2008 /EU.

Hazardous substances and mixtures shall have a label in Icelandic.

The signal words are “Hætta“ for danger and “Varúð“ for warning.

The Poison Information Centre is responsible for receiving in relation to emergency health response according to article 45.

According to Article 35 of the Chemicals Act No. 61/2013 plant protection products must have an authorisation issued by the Environment Agency in order to be placed on the market in Iceland.

Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market was implemented in Iceland on June 5th 2015 with national regulation no. 544/2015 on plant protection products.

During the transition period, which extends until 2021, plant protection products may be placed on the market in Iceland on the basis of the three following acts:

1. Temporary registration

Upon entry into force of the Chemicals Act no. 61/2013 on April 17th 2013 all registrations for plant protection products were repealed. According to the II. transitional provision of the Chemicals Act, it was possible to apply for a temporary registration of plant protection products which had a valid registration upon the entry into force of the new Act. Plant protection products granted such a temporary registration where in turn permitted to be placed on the market in Iceland for a time period based on how long the active substance in the product concerned is approved within the EU.

2. Mutual recognition of certain authorisations for plant protection products

Icelandic Regulation No 1002/2014 applies to mutual recognition of certain authorisations for plant protection products, i.e. products which have previously been granted an authorisation in another EEA-state on the basis of Directive 79/117 / EEC and 91/414 / EC, before Regulation (EU) No 1107/2009 entered into force on June 14th 2011. This regulation thus bridges the gap between older national legislation and the EC legislation on placing of plant protection products on the market.

3. National regulation No. 544/2015 on plant protection products

National regulation No. 544/2015 on plant protection products of 6th June 2015 implements regulation (EC) No 1107/2009 of the European Parliament and of the Council of October 21st 2009 concerning the placing of plant protection products on the market. Authorisations of plant protection products containing active substances approved after June 14th 2011 are governed by this regulation.


The Guidance document on work-sharing in the Northern Zone in the authorization of plant protection products describes the procedure for the submission and assessment of applications for authorisation and re-authorisation of plant protection products under Regulation EC 1107/2009 in the Northern zone.

For questions concerning the placing on the market of plant protection products in Iceland please send your inquiries to ust@ust.is.

 

Production and marketing of cosmetic products in Iceland must comply with the requirements of Icelandic regulation of cosmetic products No 577/2013 that implemented Regulation of the European Commission on cosmetic products No. 1223/2009 into Icelandic laws along with all changes of it. The EC regulation includes uniform notification process and database, the Cosmetic Products Notification Portal (CPNP), in the EEA area is established. Also this regulation demands producers and importers of cosmetic products into EEA to demonstrate the safety of products and to report adverse effects of products. Responsible person shall stand for each cosmetic product. 

The Environment Agency of Iceland is responsible for the cosmetic regulations and marketing of them, whereas local health issue operate licenses for cosmetic production in Iceland. 

“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

Production of cosmetics 

  • Production of cosmetics is subject to license from the local health. Prior to placing product on the market within the EEA area it shall be notified into the CPNP portal of EU (see the “Notification” tab). 

Marketing of cosmetics 

  • Prior to placing a cosmetic product on the market it shall be ensured that it contains only substances approved in the EEA area (see the “ingredients” tab) 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 area it shall be notified into the CPNP portal of EU (see the “Notification” tab). 

Responsible person

For all cosmetic products shall stand a responsible person which guarantees that the product meets the requirements of regulations. The responsible person can be

  • producer of the cosmetic product within the EEA area or his agent, 
  • importer of the product from countries outside the EEA area or his agent or 
  • distributor if marketing product already on the market in his own name or brand or 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 method of manufacturing and 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 

  • Labelling of cosmetic products shall be in Icelandic, English or Scandinavian language other than Finnish. However, certain labelling concerning conditions of use and warnings shall be in Icelandic. Following information shall be on label or 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 area. 
    • 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.

 Ingredients 

  • Before cosmetic product is placed on the market it shall be ensured that it contains only substances approved in the EEA area.
    • 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 are allowed colorants, preservatives and UV filters listed. 
  • On the CosIng website of the European Commision can be checked if 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. 

Notifications 

CPNP - Cosmetic Products Notification Portal 

Prior to placing a cosmetic product on the marked in the EEA area the responsible person or it´s 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 area.
  • The country within the EEA area 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 - The Rapid Alert System for Non-Food Products 

RAPEX is the EU rapid alert system that facilitates the rapid exchange of information between EU states and the European Commision 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 law, No 61/2013, the Environment Agency of Iceland plays the role of notify and view notification of products in RAPEX. The institution prepares regularly 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 this countries. In July 2014 the first list was sent to the main importers of cosmetic products in Iceland. The list includes products notified through RAPEX from September 2013 to June 2014. 

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

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