Questions and Answers

CLP

Labelling

[234] Should substances or mixtures which were already placed on the market before 1 December 2010 or 1 June 2015, respectively, and are still in stock after 1 December 2010 or 1 June 2015, respectively, be relabelled according to CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

According to Article 61(4) CLP, if the substance or mixture classified, labelled and packaged in line with Directive 67/548/EEC (Dangerous Substances Directive, DSD) or in case of mixtures Directive 1999/45/EC (Dangerous Preparations Directive, DPD) has already been placed on the market before 1 December 2010 or 1 June 2015 respectively, the substance or mixture which is still in stock does not have to be relabelled and repackaged in accordance with the CLP rules by the supplier before 1 December 2012 or 1 June 2017 respectively.
 
It is pointed out that under certain conditions, substances manufactured before 1 December 2010 and stored in the manufacturer's warehouse after 1 December 2010 and mixtures prepared before 1 June 2015 and stored in a formulator's warehouse after 1 June 2015 can benefit from the transitional arrangements provided for in Article 61(4). This would normally be the case where the transfer of ownership of the substance or mixture has taken place before 1 December 2010 or 1 June 2015 respectively although the substance or mixture does still remain in the manufacturer's or formulator's warehouse, i.e. no physical hand-over of the substance or mixture. For the notion of "placing on the market" under CLP see also FAQ ID=229
[236] Is the number of hazard statements on the label limited? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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.
[237] Is the number of precautionary statements on the label limited? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

In contrast to the number of hazard statements, the number of precautionary statements is limited on the label. The general rule is that no more than six precautionary statements shall appear on the label unless they are necessary to reflect the nature and the severity of the hazards. Advice on the selection from more than 100 different precautionary statements is given in the Guidance on labelling and packaging available at:
[238] Is a label which is designed according to legislation of non-EU countries implementing the GHS accepted in the EU? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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.
[239] Is it mandatory to include the hazard and precautionary statements together with their codes on the label? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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.
[240] When preparing hazard labels, the pre-printing of the diamond form may result in labels where not all diamonds are filled with hazard symbols. Would such empty diamonds be allowed on labels of hazardous substances and mixtures? (EDITED) Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

It is acknowledged that mass pre-printing of labels is current practice in industry. This means that the label background is printed first before it is overprinted with the specific label information in a second step. In cases where this two-step process leads to a situation where only a few hazard pictograms are needed for the label, one or more pre-printed diamonds may have to be left empty or, alternatively, be blacked-out in a second step.
 
Although CLP does not explicitly forbid the use of blank or blacked out diamonds on the label, Article 19(1) requires suppliers to include relevant hazard pictograms on the label which are intended to convey specific information on the hazards concerned. Furthermore, Article 25(3) requires that any information which goes beyond the mandatory label elements; must not contradict or cast doubt on the messages provided by the latter.
 
Therefore, due to the current lack of suitable printing techniques afforded by SMEs, it may not always be possible to only include hazard pictograms that fulfil these conditions. This means that any blank or blacked out diamond(s) should be seen in the light of this provision. In cases where empty diamonds are unavoidable, it is recommended to cover them up with a solid overprint which blacks them out completely and thereby avoids the impression that relevant hazard symbols may have been left off the label through a printing mistake.
[241] Do active substances, plant protection products and biocidal products have to be labelled in accordance with CLP? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 02/02/2016

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).

[242] Is a supplier always required to provide their contact details on the label? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

Yes they are. CLP Article 17 (1) (a) states that the name, address and telephone number of the supplier(s) must be included on the label. Furthermore, pursuant to Article 4 (4) a supplier shall ensure that a hazardous substance or mixture is labelled and packaged in accordance with Titles III and IV of the CLP Regulation before placing it on the market.
 
In principle, there can be more than one supplier of the same hazardous substance or mixture in the supply chain at the same time, e.g. when a hazardous substance or a mixture containing hazardous substances has been supplied to a distributor, who then supplies it to third parties. If the distributor then changes the packaging to such an extent that the label elements set out in CLP Article 17 have to be displayed differently than on the original label/packaging supplied, then the contact details of the distributor should be added to or replace the contact information of the previous supplier. In this scenario, the distributor has taken on the responsibility for repackaging and re-labelling of the substance or mixture.
 
If distributors do not change the packaging or labelling, then they do not need to add their contact details to the label nor replace the contact information of their supplier. The distributors may, however, do so if they wish to.
 
In case a supplier changes the languages(s) displayed on a label, they become responsible for the correct translation of the label content. Thus, they should add their contact details to the contact details of the supplier who issued the original label.
[243] May non-EU hazard information be included on the label along with CLP labelling elements for substances placed on the EU market? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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

[244] When designing a label, what are the requirements regarding dimensions and make up of the hazard pictograms, to be used on the label? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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 1.2.1.4 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

[245] When a package carries a transport label or mark that corresponds to the same hazard as a CLP pictogram, can the CLP pictogram be omitted? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

Yes, it can. It is specified in Article 33 (1) and (3) of the CLP Regulation that where a hazard pictogram required by CLP relates to the same hazard as in the rules for the transport of dangerous goods then the CLP pictogram for that same hazard can be omitted from the outer packaging. 
 
In section 5.4 "Interaction between the CLP and the transport labelling rules" of the Guidance on labelling and packaging in accordance with the CLP Regulation, available at http://echa.europa.eu/guidance-documents/guidance-on-clp, it is stated that transport labelling, as referred to in CLP Article 33, includes all marks required by transport legislation, e.g. the mark for environmentally hazardous substances, elevated temperature marks or limited/exempted quantities marks. Therefore, the pictograms depicting the same hazard do not need to appear twice.
[246] If a substance or mixture is produced exclusively for the non-EU market, does it need to be labelled in accordance with CLP before export? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 02/02/2016

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.

[247] Can the outer packaging display both CLP and DPD labelling when the inner components are made up of a CLP compliant substance and a DPD compliant mixture? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

Yes, it can. Although it was not foreseen to have both CLP and DPD labelling on the outer packaging at the same time, in cases where both the inner and outer labels are compliant with their respective legislative remits, namely CLP and DPD during the transitional period, it is acceptable to have both types of labels on the outer packaging until 1 June 2015, as long as the labelling of the different components is clearly distinguished in the outer packaging. However, if the mixture is voluntarily classified in accordance with CLP before that date, both the inner and outer label for the mixture need to be updated to meet the requirements of CLP.
 
However, as this type of combined CLP and DPD labelling may cause some confusion for end users during the transitional period, those with the responsibility of labelling such products are advised to avoid mixed CLP and DPD labelling where practicable.
[248] Should substance names used on the label be in the official language(s) of a Member State? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

Yes, they should. It should be kept in mind that labels are meant for health, environment and consumer protection, thus they must be understood by the users of the products.According to 17(2) of CLP, the label shall be written in the official languages(s) of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise. 
 
Therefore, substances currently listed in English only in Part 3 of Annex VI to CLP or in the C&L Inventory need to be translated into the official languages(s) of the Member State(s) where it is placed on the market unless the Member State(s) provides otherwise.
 
ECHA plans to make available the translated chemical names of the Annex VI entries in a later version of the public C&L Inventory.
[249] Do containers used for the transport of bulk chemicals (e.g. portable tanks and trailers) meet the definition of a package and fall within the remits of CLP Article 33(3) and as a consequence should they be labelled accordingly? --New Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

CLP Regulation is not applicable to transport of dangerous goods by air, sea, road, rail or inland waterways, except for the labelling requirements set out in CLP Article 33. Article 33(3) CLP states that single packages that meet the labelling provisions set out in the rules on the transport of dangerous goods shall be labelled both in accordance with CLP Regulation and the transport rules.
 
As CLP does not define what constitutes a 'single package', for the present purposes the definition of 'single package' is taken from the rules on the transport of dangerous goods. The rules on road, rail and inland waterway transport are implemented in Europe by Directive 2008/68/EC. From Annex I, Annex II, and Annex III to Directive 2008/68/EC and the definitions of the ADR it can be inferred that packaging (e.g. boxes, drums and jerry cans), large packaging and IBC are considered to be packaging for transport purposes in the context of CLP Article 33(3) and therefore both a CLP and transport label are required.
 
In contrast, tanks, bulk containers and freight containers are not considered packaging or single package according to Directive 2008/68/EC and the exclusion stated in CLP Article 1(6) may be considered fully applicable during the transport activities. 
[250] When should an importer label their substances/mixtures in line with CLP? --New Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

Substances and mixtures must be appropriately labelled in accordance with CLP before they are placed on the market, i.e. made available to third parties.Under REACH and CLP Regulations, import is considered to be placing on the market and it is the obligation of an importer to provide labels in line with CLP for substances/mixtures they place on the market. It is, however, at the discretion of the importer to decide when and how this happens, as long as the labels are on the packages when the substance/mixture is placed on the market. They may decide whether this is done by a non-EU supplier, during customs supervision or without undue delay after it reaches its destination.
 
Where importers make use of a distributor, they may not pass this labelling duty to their distributor. The substance/mixture being distributed should be adequately labelled by the importer before it reaches the distributor. 
[251] When is it relevant to allocate the supplemental hazard statement EUH029 - "Contact with water liberates toxic gas" -to a substance or mixture? --New Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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.
[252] Are there any exemptions in the CLP Regulation for chemicals supplied in very small quantity packages, when they are considered to present a very low risk? --New Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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.

[848] May a supplier put the name, address and phone number of another supplier on the label? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 0.0
Latest update: 04/06/2015

Yes, they may. Private labelling is commonly used by industry whereby products are made by a contract manufacturer under licence using different brand labels for different suppliers. Although the CLP Regulation does not explicitly refer to private labelling, its provisions apply in this case. 
 
In accordance with Article 17(1)(a) of the CLP Regulation, a substance or mixture classified as hazardous and contained in packaging shall bear a label including, among others, the name, address and telephone number of the supplier(s). Based on this provision, it is possible to place the name, address and telephone number of more than one supplier on the label. The contact details of any supplier in the supply chain are allowed to be included on the label. More information can be found in the Guidance on labelling, section 4.1, and in the CLP FAQ on labelling (unique ID 242).
 
The responsible supplier should be able to provide additional information in the language of the country where the product is placed on the market.
[1050] If a mixture contains more than four substances contributing to the classification of the mixture, which substances should be identified on the label? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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.

[1051] Are CLP pictograms required when outer packaging is marked with the ‘limited/excepted quantity marks’ according to the rules on the transport of dangerous goods? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 04/06/2015

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.

[1137] When must the precautionary statement P501 be included on the label of a substance or mixture supplied to the general public? Questions on REACH, CLP and BPR marked as Frequently Asked Questions (FAQ) have been agreed between ECHA, the national helpdesks and the European Commission to ensure consistency and accuracy. - FAQ
CLP
Labelling
Version: 1.0
Latest update: 09/10/2015

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.