Questions and Answers
The number of hazard statements on the label is in principle not limited as they will normally have to reflect all hazard classifications of a substance or mixture. The only exception is for evident duplication or redundancy.
In the EU, only those labels which comply with the CLP rules will be accepted. This means that those provisions that are laid down in Title III of the CLP Regulation and the details regulated in its Annexes I – V must be respected. However, many aspects in relation to the arrangement of labelling elements and in relation to supplemental labelling information are at the discretion of the supplier of the hazardous substance or mixture.
No, it isn't. CLP Articles 21 and 22 require that the statements as such are put on the label, in accordance with the wording provided in Annex III and Annex IV, Part 2. The codes corresponding to these statements are not required for the label, but are not explicitly excluded. It is up to the supplier to decide whether he will include the codes on the label as well.
Yes, they do. Active substances, plant protection products within the scope of Regulation (EC) No 1107/2009 or biocidal products within the scope of Regulation (EU) 528/2012, which are classified as hazardous, must bear a CLP label including the relevant hazard statements, precautionary statements, signal word and pictograms.
In addition, the label of a hazardous plant protection product must also display the statement EUH401 ("To avoid risks to human health and the environment, comply with the instructions for use"). However, in relation to any other aspects of labelling, the provisions of the respective regulations apply, e.g. for the update of a label of a plant protection or biocidal product, see CLP Articles 15(5) and 30(3). Further information can be found in the Guidance on labelling and packaging in accordance with the CLP Regulation available on the ECHA website at http://echa.europa.eu/guidance-documents/guidance-mainly-for-industry-use
Note that an active substance can also be placed on the market for non-pesticidal or non-biocidal uses. In these cases, the labelling provisions set out in CLP Title III apply in full. This means, for example, that the update of the relevant label has to follow the provisions of CLP Article 30(1) and (2).
CLP Article 25 introduces the concept of "supplemental information", which is intended to incorporate additional labelling information 'over and above' that listed in CLP Article 17 (1) (a) to (g). Any non-EU hazard information included along with the CLP label elements may be considered as supplemental information and placed alongside the CLP labelling elements so long as it does not contradict or cast doubt on the validity of the information required by CLP Article 17 (1) (a) to (g), nor makes it more difficult to identify such information. This can only be determined on a 'case by case' basis depending on the information being proposed by the importer. Additional guidance on supplemental labelling information can be found in Section 4.8- 'Supplemental labelling information' of the CLP labelling and packaging guidance available on the ECHA website at http://www.echa.europa.eu/guidance-documents/guidance-on-clp
The general rules for the application of labels are outlined in CLP Article 31. For the hazard pictograms, as detailed in CLP Article 31 (4), the provisions of Annex I, Section 1.2.1, to CLP and Annex V to CLP shall apply. According to Annex V to CLP, hazard pictograms shall have a black symbol on a white background with a red frame wide enough to be clearly visible. Hazard pictograms shall be in the shape of a square set at a point. Each hazard pictogram shall cover at least one fifteenth of the minimum surface area of the label dedicated to the information required by CLP Article 17 (as defined in Table 1.3 in Section 18.104.22.168 of Annex I, 2nd ATP to CLP). Where a supplier chooses to use a label that is larger than the minimum dimensions for a certain capacity of the package, it is not necessary for the size of the pictogram also to be increased, provided it covers one fifteenth of the relevant minimum dimensions and remains proportional to the size of the packaging. The minimum area of each hazard pictogram shall not be less than 1 cm². Note that the size of the pictogram relates to the dimensions of the pictogram itself, and not to the size of the virtual square where the pictogram is embedded. Further guidance can be found in Section 5.2- 'Size of the label and of the label elements' of the Guidance on labelling and packaging in accordance with the CLP Regulation available on ECHA's website at: http://www.echa.europa.eu/guidance-documents/guidance-on-clp
The CLP Regulation does not require the labelling of substances or mixtures that are only exported and that, within the EU, are only subject to transport operations. It is necessary to take worker health and safety considerations into account during the production packaging and storage stages, to ensure that these substances and mixtures are handled safely.
However, the PIC Regulation ((EU) 649/2012) concerning the export and import of hazardous chemicals (which implements the Rotterdam Convention within the EU) requires that all exported chemicals are classified, labelled and packaged in accordance with the CLP Regulation, the Plant Protection Products Regulation ((EC) No 1107/20), the Biocidal Products Regulation ((EU) No 528/2012) or any other relevant EU legislation, unless those provisions would conflict with any specific requirements of the receiving countries. Further information can be found in sections 4.1 and 6.10 of the Guidance for implementation of the PIC Regulation.
The labelling and packaging requirements for hazardous transported goods are laid down in the respective transport legislation, based on the UN Model Regulations.
According to the criteria given in section 1.2.1 of Annex II to CLP, the hazard statement applies to 'substances and mixtures which in contact with water or damp air, evolve gases classified for acute toxicity in category 1, 2 or 3 in potentially dangerous amounts, such as aluminium phosphide, phosphorous pentasulphide.' No further criteria or guidance are provided as to when this hazard statement should be assigned and no appropriate test methods are indicated. It is recommended that any amount of acute toxic category 1, 2 or 3 gas emitted triggers the inclusion of EUH029. It is thus also recommended to add this sentence to each substance or mixture that releases a toxic gas when in contact with water.
No. Substances or mixtures under the scope of the CLP Regulation can not be exempted from the classification, labelling and packaging requirements regardless of how low the risk is estimated to be and regardless of the size of the packaging. However, certain derogations apply for labelling of small packagings according to Article 29 of CLP.
Article 18(3) of CLP provides that the identity of all substances in a mixture that contribute to the classification of the mixture in certain hazard classes must be given on the label. A maximum of four chemical names are to be included, unless more are needed to reflect the nature and severity of the hazards.
There are no strict rules on how to decide which substances should take precedence to be named on the label, but the following may help in the selection.
For non-additive health hazards (e.g. germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation and specific target organ toxicity categories 1 and 2), all ingredients which are present in the mixture above the generic or specific concentration limit should be considered as ”primarily responsible for the major health hazards” within the meaning of Article 18(3)(b) CLP and included on the label.
For the additive health hazards mentioned in Article 18 (3)(b) CLP (e.g. acute toxicity, skin corrosion, serious eye damage, specific target organ toxicity category 3 and aspiration hazard), all ingredients which are present in the mixture above the generic or specific concentration limits should be included on the label. However, where there are several ingredients contributing to classification for one hazard endpoint, only the ingredients primarily contributing to the classification, for example, those closest to the GCL or SCL, need to be included on the label, and thus the names of other ingredients with limited contribution to the classification are not required.
In addition, specific labelling rules apply to mixtures containing skin and respiratory sensitisers. See Annex I Table 3.4.3 and Annex II, point 2.8.
No, they are not. Article 33(1) of CLP outlines that when a package consists of an outer and an inner packaging, together with an intermediate packaging, and the outer packaging meets the labelling provisions in accordance with the rules on the transport of dangerous goods, the hazard pictograms required by CLP do not need to appear on the outer packaging.
For the purpose of CLP, transport labelling is considered to include the limited/excepted quantity marks (chapters 3.4 and 3.5 of the UN Model Regulations for the transport of dangerous goods). This is explained in the Guidance on labelling and packaging (chapter 5.4) that states that labelling in accordance with CLP is required only when neither:
- 'normal' transport labelling elements, nor
- other transport labelling elements such as ‘limited/excepted quantity marks' are needed on the outer packaging.
This means that limited/excepted quantities are considered as transport labelling and therefore CLP pictograms are not required when those limited/excepted quantity marks are carried on the outer packaging. CLP labelling may however be used, if desired according to Article 33(1) of CLP.
The precautionary statement P501 with appropriate specification of where to dispose of the content/container (e.g. public waste disposal or recycling facility), in accordance with the applicable regulation, must be included on the label of any substance or mixture supplied to the general public if the substance or mixture is classified in the hazard classes and categories listed under P501 in Table 6.5 of Annex IV to the CLP Regulation.