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Before 1 June 2015, any supplier (manufacturer, importer, downstream user or distributor) was entitled to attach a DPD label (label in accordance with the Dangerous Preparations Directive (1999/45/EC) on its mixture before placing it on the market, as long as it had been classified according to the same directive.
Alternatively, suppliers could choose to attach a CLP label instead, provided that the mixture had been classified according to CLP.
After that date, suppliers must attach a CLP label.
However, there is a limited derogation available where a mixture classified, labelled and packaged in line with the DPD, which has already been placed on the market before 1 June 2015 does not have to be re-labelled and re-packaged in accordance with the CLP rules before 1 June 2017 (Article 61(4) CLP)1.
Therefore, formulators or importers who have placed a mixture on the market before 1 June 2015, which is correctly labelled and packaged in accordance with the DPD, does not need to recall the mixture for re-labelling and re-packaging. This mixture can continue to be supplied further down the supply chain, without changes to its labelling and packaging, provided other actors do not change the composition of the mixture in any way.
This implies that re-labelling due to a change of name or contact details of suppliers or language (e.g. a mixture placed on the market of a Member State before 1 June 2015 and transferred between 1 June 2015 and 1 June 2017 to the market of another Member State requiring re-labelling in the language of the other Member State) does not trigger the obligation to re-label a DPD-labelled mixture according to CLP.
This derogation might be applied, for example, to mixtures that are on the shelf in a warehouse, in a shop, or in the stocks of a formulator or importer and are in a condition which is ready to be sold or supplied. This derogation is not available to mixtures under customs supervision which fall within the scope of Article 1(2)(b)).
For the derogation to apply, suppliers should be able to show that the mixtures were already correctly packaged and labelled in accordance with DPD on 1 June 2015 and had been placed on the market before that date, e.g. when made available for a third party even though the mixtures may still be stocked in the formulator’s, importer’s or distributor’s warehouse. This could be shown, for example, by proof that on that date the mixture had been formulated, packaged and labelled and had passed a formulator’s quality control system (“cleared for sale/supply”).
Formulators are encouraged to start re-labelling the mixtures that they already placed on the market, well before 1 June 2017 to ensure that distributors and other actors down the supply chain are not prevented from selling their stocks of DPD-labelled mixtures after 1 June 2017. Distributors and other actors down the supply chain are similarly encouraged to buy CLP-labelled products early enough to ensure that their stocks of DPD-labelled mixtures have been sold by 1 June 2017.
Foot note 1) This derogation does not apply to liquid consumer laundry detergents in soluble packaging for single use, which had to be re-labelled in accordance with CLP since 31 December 2015, in accordance with Article 2(2) of Commission Regulation (EU) No 1297/2014.
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 the 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.
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.
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).
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, as stated in Article 4 (4), a supplier must 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. This can be the case, for example, 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.
When 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.
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 184.108.40.206 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.
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 must 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, the translated names of substances listed in Part 3 of Annex VI to CLP or in the C&L Inventory need to be used in the Member State(s) where placed on the market unless the Member State(s) provides otherwise. The public C&L Inventory does not contain translations for substances that do not have a harmonised classification of the Annex VI entries.
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 in accordance with the CLP Regulation (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 the ‘limited/excepted quantity marks', the mark for environmentally hazardous substances or elevated temperature 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 and the pictograms depicting the same hazard do not need to appear twice. 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.
Suppliers of substances and mixtures classified as hazardous according to CLP must label them in accordance with CLP before placing them on the market.
A supplier is any manufacturer, importer, downstream user or distributor placing a substance on the market on its own or in a mixture. Import is considered to be placing on the market (Article 2(18) CLP). Therefore, an importer (supplier) importing (placing on the market) substances or mixtures will have to label them according to CLP. Imported substances and mixtures require CLP labelling, even if the importer and the user are the same legal person.
Where importers make use of a distributor, the importers may not pass this labelling duty to their distributor. The substance/mixture being distributed should be correctly labelled by any supplier (including the importer) in the supply chain.
An importer is not required to classify, notify or label its substances/mixtures in accordance with CLP if the following conditions apply (note that they apply cumulatively):
- the substances/mixtures are under customs supervision;
- there is no treatment or processing activity;
- one of the three following (not cumulative) conditions apply: the substances/mixtures are (a) in temporary storage or, (b) in a free zone or free warehouse with a view to re-exportation or, (c) in transit.
In customs terms, transit means both internal and external transit. In case of doubt, it is recommended to contact the customs authorities, to clarify the applicable customs rules established by Regulation (EU) No 952/2013 on the Union Customs Code.
No, it is not. A hazardous chemical product that is subject to labelling and packaging under CLP must not be confused with a food, medicinal or cosmetic product. For example, a prominent picture of a fruit on the label or packaging can create confusion for the consumer and increase attractiveness to children. Other elements, such as the bright colour, the shape and design of the packaging or the consistency of the chemical may also create a resemblance with food products or with toys.
A hazardous chemical product must not attract the curiosity of children, but apart from children, other vulnerable consumer groups also exist and need to be considered. Therefore, the packaging of a hazardous chemical should not be of a shape or design that, for example, a visually impaired person could confuse with food.
E-liquids for electronic cigarettes are regulated by the Tobacco Products Directive (TPD, Directive 2014/40/EU). The TPD requires Member States to ensure that electronic cigarettes and their refill containers are only placed on the market if they comply with the TPD and with all other relevant Union legislation (Article 20(1)), including the obligations under the CLP Regulation.
Under CLP, the classification, labelling and packaging of an e-liquid is the responsibility of the formulators or importers of the liquid. Under TPD, they must also submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market. This notification should include the classification of the mixture in accordance with CLP.
The TPD sets its own labelling requirements for the unit packets of electronic cigarettes and refill containers (TPD Article 20(4)). In addition, the refill containers must also be labelled and packaged in accordance with CLP if the e-liquid is classified as hazardous. In that case, the unit packet must have a CLP label, with TPD-related information as supplemental. Overlapping information only needs to be indicated once: for example, the list of all ingredients required by TPD vs the list of ingredients contributing to classification under CLP.
It should be noted that the TPD provides that the nicotine content must not exceed 20 mg/ml and only ingredients that do not pose a risk to human health in heated or unheated forms may be used in the nicotine-containing liquid. However, other components of e-liquids have also been identified as hazardous and need to be considered in the classification and labelling of the e-liquid.
According to TPD, electronic cigarette devices and refill containers have to be child- and tamper-proof, protected against breakage and leakage and have to have a mechanism that ensures refilling without leakage (Article 20(3)g).
A refillable electronic cigarette device that is empty when placed on the market is not subject to the labelling obligations under CLP, as the hazards are dependent on the contents of the refill container.