Classification and labelling – CLP

  1. What language requirements apply to the labeling of hazardous substances and mixtures in Iceland?
    The legal language concerning labelling hazardous substances and mixtures is Icelandic according to  the Icelandic Law on Chemicals (Efnalög) No. 61/2013 (article 32), and the national Regulation No. 415/2014 (article 4) that implements Regulation (EC) No. 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP Regulation).

  2. What is meant by the term "marketing" within the CLP regulation?
    Placing a substance or a mixture on the market under CLP means offering the product to a third party, whether for a fee or free of charge within the borders of the EU member states and the EEA states that have implemented the CLP regulation. Imports into the customs territory of those countries that have implemented the CLP regulation are also considered to be marketing.

  3. When does the importer need to label substances and mixtures under the CLP Regulation?
    Substances and mixtures should be labelled in accordance with the CLP Regulation before the product is placed on the market, ie. made available to third parties. According to the REACH and CLP regulations, imports means that the product is placed on the market, and therefore it is the duty of importers to prepare Icelandic labels in accordance with the CLP regulation for substances and mixtures when they place them on the market. However, it is up to the importer to decide when and how this happens as long as the labels are on the products when they are placed on the market.
    When an importer makes a use of a distributor, it is not the responsibility of the distributor to fulfill the obligation to label. The importer must, therefore, adequately label the substance / mixture before the product comes into the hands of the distributor.

  4. Is it allowed to use labelling according to Directive 67/548 / EEC and 1999/45 / EC?
    No, as of June 1, 2017, only substances and mixtures classified and labelled according to Regulation no. 415/2014 on the classification, labelling and packaging of substances and mixtures, which introduces EU Regulation no. 1272/2008 (CLP) in Iceland are allowed on the market.

  5. Are the number of hazard statements on the label limited?
    The number of hazard statements on the label is generally not limited as they are intended to display all hazard classes of a substance or a mixture. An exception is only made for duplicates or information that is considered redundant.

  6. Is the number of precautionary statements on the label limited?
    In contrast to the number of hazard statements, the number of precautionary statements on the label is limited. The general rule is that precautionary statements on the label should not be more than six unless it is considered necessary to indicate the nature or severity of the hazard. Advice is given on the selection of precautionary statements in the ECHA publication "Guidance on labeling and packaging in accordance with Regulation (EC) No 1272/2008" which can be accessed at the following link: https://echa.europa.eu/documents/10162/23036412/clp_labelling_en.pdf/89628d94-573a-4024-86cc-0b4052a74d65

  7. When preparing a label with pre-printed diamond shapes, it may happen that not all the diamonds need to be filled out with a hazard warning sign. Is it possible to have empty diamonds on labels for hazardous substances and mixtures?
    When preparing hazard labels, a common practice is to use pre-printed label stocks of the diamonds (the label background is printed first before it is overprinted with the specific label information). This may result in labels with a number of pre-printed empty diamonds, not all of which may then be needed by a company that has purchased pre-printed labels. In such a situation one or more pre-printed diamonds may have to be left empty.
    CLP does not explicitly forbid blank diamonds. However, any information given in addition to the minimum mandatory labelling must not contradict or cast doubt on the mandatory label information (Article 25(3)), while empty red frames might raise questions. If empty red frames are unavoidable, it is recommended to cover them up with a solid overprint which blacks them out completely.

  8. Are suppliers always required to record information about them self on a label?
    Yes. Article 17 (I1 (a)) states that the supplier's / supplier's name, address and telephone number must appear on the label. Furthermore, Article 4. (4) states that „Where a substance or mixture is classified as hazardous, suppliers shall ensure that the substance or mixture is labelled and packaged in accordance with Titles III and IV, before placing it on the market.“
    If the distributor changes the packaging to the extent that the labelling will change according to Article 17, information about that distributor must be included on the labelling. Under such circumstances, the distributor has taken responsibility for the repackaging and re-labelling of the substance or mixture.
    In cases where suppliers change the language of the label, they will be responsible for the correct translation of the content. Therefore, they should add information about themselves to the label.
    If distributors do not change the packaging or labelling, they do not need to add information about them self as a contact on the label or change the information about the person who provided the product. Distributors, however, are free to do so, if they so wish.

  9. When designing a label, what are the requirements about the hazard pictograms, and the size of the label and of the label elements?
    General rules on the labelling are set out in Article 31 of the CLP Regulation. According to the Art. (4) the pictograms should comply with the provisions of Annex I, Section 1.2.1, and Annex V of the CLP Regulation.
    The warning signs should be labelled in black on a white background and around them a red diamond large enough to be clearly visible. Each hazard pictogram shall include at least one-fifteenth of the minimum surface of the CLP label (see Table 1.3 in Section 1.2.1.4 of Annex I for further details). If the seller chooses to use a label in excess of the minimum size, it is not necessary to also enlarge the pictogram, as long as it covers one fifteen of the minimum size label and is proportional to the size of the package. The minimum dimension of each pictogram shall not be less than 1 cm2.

    The following rules apply to the minimum dimensions of label and pictograms:
    Capacity of the package
    Dimensions of the label (in millimetres) for the information required by Article 17
    Dimensions of each pictogram (in millimetres)
    Not exceeding 3 litres:
    If possible, at least 52 x 74
    Not smaller than 10 x 10
    If possible, at least 16 x 16
    Greater than 3 litres but not exceeding 50 litres:
    At least 74 x 105
    At least 23 x 23
    Greater than 50 litres but not exceeding 500 litres:
    At least 105 x 148
    At least 32 x 32
    Greater than 500:
    At least 148 x 210
    At least 46 x 46


    Further instructions can be found in section 5.2, "Size of the label and of the label elements" in Guidance on labeling and packaging,
    https://echa.europa.eu/documents/10162/23036412/clp_labelling_en.pdf/89628d94-573a-4024-86cc-0b4052a74d65

  10. What body or bodies will receive information relating to emergency health response in accordance with Article 45 of Regulation (EC) No. 1272/2008 and how should they be presented?
    Eitrunarmiðstöð Landspítalans (Landspítali Posion Centre) is at the moment the appointed body in Iceland responsible for receiving information from importers and downstream users (submitters) relating to emergency health response according to Article 45 of the CLP-regulation. Contact by email: eitur@landspitali.is or telephone: +354 5432222. . The information shall be submitted to the Toxic Center in the form of safety data sheets (SDS).
    Changes regarding this information reception are to become in the near future in the sense that the European Chemicals Agency (ECHA) will receive information from submitters on mixtures in conjunction with Article 45 through the coordinated central ECHA portal (PCN), thus addressing the role of nation states in terms of information gathering.
    When registering in the EU portal more detailed information is required than what the SDS contain regarding the chemical composition of the mixture and, at the same time, the contributors need to provide information of a so called UFI code of the product. The information that needs to be included is specified in VIII. Annex of Regulation (EC) 1272/2008.
    The first deadline to register in the ECHA portal is January 1, 2021 (the deadline has been extended from the original claim of January 1, 2020).


  11.  What is UFI?
    UFI is an abbreviation for "Unique Formula Identifier". UFI is a 16-charcter code which is characteristic of one particular type of mixture or group of mixtures of the same nature. Hence the code links a specific product on the market to the submitted mixture information.
    UFI will be required on the labeling of chemical products containing hazardous mixtures as of January 1, 2021, and all mixtures on the market must be included with this code as part of the packaging label of the product by the end of 2025. Furthermore, UFI codes will be required for registration of information in the centralized ECHA's poision center, so national poision centers can quickly identify toxicological effects to determine appropriate emergency response. (For further details see Annex VIII of Regulation 1272/2008 and ECHA‘s information site; https://poisoncentres.echa.europa.eu/ufi-generator)