This Hazard Information and Packaging Special Report will examine the specific supply labelling requirements that result from various EU regulations, in particular those related to Classification, Labelling and Packaging (Regulation (EC) 1272/2008) (CLP), biocides (Regulation (EU) No. 528/2012) (BPR) and detergents (Regulation (EC) No. 648/2004) (DPR). It will describe the specific labelling requirements specific to each of these legislative areas and their interdependence.
The report will also contain some more general comments on product supply labelling and its importance in helping to ensure that users/consumers understand the intrinsic hazards of the products they are using, and how to handle, use, store and dispose of them safely.
This article will summarise the supply label requirements for chemical products.
Labelling for the transport of dangerous goods falls outside the scope of this report, except in those situations where combined labelling is allowed.
For more detailed information on labelling requirements the reader is advised to consult the legislative texts (CLP and DPR) and the detailed guidance and Q&A support available on the ECHA website for CLP and BPR.
Regulation (EC) No. 1272/2008 (as amended) on the classification, labelling and packaging of substances and mixtures (CLP) came into force on 20 January 2009. The CLP labelling deadline for substances is well past; however, mixtures must be classified, labelled and packed according to CLP at the latest from 1 June 2015. By way of derogation, mixtures already “placed on the market” before that date do not need to be relabelled and repackaged according to CLP until 1 June 2017.
If not classified and labelled to CLP then mixtures must be classified and labelled to the 1999/45/EC Dangerous Preparations Directive (DPD), which is implemented in Great Britain by the Chemicals (Hazard Information and Packaging for Supply) Regulations 2009 (SI 2009 No. 716) (CHIP4).
Labelling under CLP
Title III of CLP is called “Hazard Communication in the Form of Labelling” and in Articles 17 to 34 covers the content and application of labels.
A substance or mixture contained in packaging should be labelled according to CLP rules before placing it on the market:
- when a substance is classified as hazardous
- when a mixture contains one or more of certain substances classified as hazardous above a certain threshold, even if the mixture itself is not classified as hazardous
- if it is an explosive article.
CLP defines the content of the label and the organisation of the various labelling elements. The label includes:
- the name, address and telephone number of the supplier
- the nominal quantity of a substance or mixture in the package made available to the general public (unless this quantity is specified elsewhere on the package)
- product identifiers
- where applicable, hazard pictograms, signal words, hazard statements, precautionary statements and supplemental information required by other legislation.
The labelling elements should be clearly and indelibly marked on the label and should stand out clearly from the background, and be of such size and spacing as to be easily read.
Note that specific labelling requirements are laid down in Section 1.3 of Annex 1 to CLP that apply to the following:
- transportable gas cylinders
- gas containers intended for propane, butane or liquefied petroleum gas
- aerosols and containers fitted with a sealed spray attachment and containing substances classified as presenting an aspiration hazard
- metals in massive form, alloys, mixtures containing polymers, mixtures containing elastomers
- explosives, as referred to in Section 2.1 of Annex 1 to CLP, placed on the market with a view to obtaining an explosive or pyrotechnic effect.
The above are not considered further in this report.
Who should label?
A manufacturer, importer, downstream user (including formulator) or distributor (including retailer) should label any substance or mixture requiring labelling and contained in packaging, before placing it on the market. This also applies to producers and importers of articles which are explosive according to the CLP criteria.
A distributor need not classify from scratch for the purposes of labelling, but may take over the classification of the substance or mixture from their supplier, provided it is derived in accordance with CLP Title II. The same applies to downstream users, provided they do not change the composition of the substance or mixture supplied to them.
Labels should be written in or include the official language(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. (So far only Ireland has done so, making use of Irish language optional, in addition to English.)
The various label elements of CLP are discussed below.
Name, address and telephone number of the supplier(s)
The name, address and telephone number of the supplier(s) must be included on the label.
In principal, there can be more than one supplier of the same hazardous substance or mixture in the supply chain at the same time, eg when supplied to a distributor who then supplies it to third parties. 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 distributor may, however, do so if they wish to.
If, on the other hand, the distributor changes the packaging to such an extent that the label elements 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 relabelling of the substance or mixture.
Where a supplier changes the language(s) displayed on the label, they become responsible for the correct translation of the label content. They should add their contact details to the contact details of the supplier who issued the original label.
The product identifier on the label and in the product SDS must be the same.
For substances a chemical name and an identification number such as an EC number or CAS number are required, if available.
For mixtures both the following are required.
- The trade name or the designation of the mixture.
- The identity of all the substances in the mixture that contribute to the classification of the mixture as to acute toxicity, skin corrosion or serious eye damage, germ cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitisation, specific target organ toxicity (STOT), or aspiration hazard.
There is no need to use more than four chemical names unless necessary due to the nature and severity of the hazards. The chemical names selected should identify the substances primarily responsible for the major health hazards which have resulted in the classification and choice of hazard statements.
Chemical names should be written in the official language(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 (see above regarding the Irish language).
In the case of certain mixtures, if declaring a specific chemical name on the label is considered to put at risk confidential business information or intellectual property, a request can be submitted to ECHA to use a more descriptive general name identifying the most important functional groups or an alternative designation. However, it is important to first consult CLP Article 24 and Annex 1 Section 1.4.1 where the full criteria are laid out, including the limited list of hazard categories where the use of an alternative name could potentially be allowed.
A hazard pictogram is a pictorial presentation of a particular hazard. The classification of a substance or mixture determines which hazard pictograms, if any, should be displayed on the label to reflect the physical, health and/or environmental hazards of the product. The pictograms, which are diamond shaped, are significantly different from those of the previous regulations, and are consistent with those used under the transport of dangerous goods. Table 1 gives details of the CLP pictograms, their GHS Code Numbers and their use.
Table 1: Hazard Pictograms
Where the classification of a substance or mixture would result in more than one pictogram on the label, the rules of precedence (Article 26) may be applied to reduce the number of pictograms required.
For example for health hazards:
- if GHS06 (skull & crossbones) applies, then GHS07 (exclamation mark) should not appear
- if GHS05 (corrosion) applies, then GHS07 (exclamation mark) should not be used for skin or eye irritation, but may still be used for other hazards.
For full precedence details the CLP text and ECHA guidance should be consulted.
In the case of pre-printed labels where the background (including pictogram outlines) is printed first before it is overprinted with specific label information, the current ECHA recommendation (Q&A No. 240) is to cover any empty diamonds with solid overprint. This is to avoid giving the impression that relevant hazard symbols may have been left off the label through a printing mistake.
Signal words – “Danger” or “Warning”
A signal word indicates the degree of severity of the hazard. The label should include the relevant signal word in accordance with the classification of the hazardous substance or mixture. For a more severe hazard the label should bear the signal word “Danger”, and for less severe hazards the signal word “Warning”.
The signal word requirement for each specific classification is set out in the tables indicating the label elements required for each hazard class as set out in Parts 2 to 5 of Annex I to CLP. Some hazard categories (eg explosives, division 1.6) do not have a signal word.
Under the precedence rules for labelling, where the signal word “Danger” is required the signal word “Warning” shall not appear on the label.
The label needs to bear the relevant hazard statements describing the nature and severity of the hazards of the substance or mixture. The hazard statements relevant for each specific hazard classification are set out in the tables contained in Parts 2 to 5 of Annex I to CLP.
Annex III to CLP lists the correct wording of the hazard statements and their translations as they should appear on the label. The hazard statements of one language should be grouped together with the precautionary statements of the same language on the label.
Each hazard statement in Annex III is assigned a unique alphanumerical code which consists of one letter (H) and three numbers. The starting digit “2” refers to physical hazards, “3” to health and “4” to environmental. Some examples are given in Table 2 below.
|H225||Highly flammable liquid and vapour.|
|H290||May be corrosive to metals.|
|H303||May be harmful if swallowed.|
|H317||May cause an allergic skin reaction.|
|H411||Toxic to aquatic life with long lasting effects|
The wording of a number of the hazard statements is different from the wording of the equivalent Risk Phrases under previous legislation.
The codes corresponding to the hazard statements are not required for labels, but can be included on a voluntary basis by the supplier.
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.
The labels should bear the relevant precautionary statements, giving advice on measures to prevent or minimise adverse effects to human health or the environment arising from the hazards of the substance or mixture.
Precautionary statements should be selected in line with Article 28 and with Part 1 of Annex IV to CLP. Any selection should take into account the hazard statements used and the intended or identified use or uses of the substance or mixture.
Normally no more than six precautionary statements should appear on the label, unless more are necessary to fully reflect and take account of the nature and severity of the hazards.
Part 2 of Annex IV to CLP lists the correct wording of the precautionary statements as they should appear on the label.
As with hazard statements, each precautionary statement in Annex IV is assigned a unique alphanumerical code which consists of one letter (P) and three numbers. The starting digit “1” refers to General precautions, “2” to Prevention, “3” to Response, “4” to Storage and “5” to Disposal. Some examples are given in Table 3 below.
|P102||Keep out of reach of children.|
|P243||Take precautionary measures against static discharge.|
|P262||Do not get in eyes, on skin, or on clothing.|
|P273||Avoid release to the environment.|
|P314||Get medical advice/attention if you feel unwell.|
|P302 + P352||IF ON SKIN: Wash with plenty of soap and water.|
|P403||Store in a well-ventilated place.|
|P501||Dispose of content/container to…|
As with the hazard statements the code numbers are not required for labels.
CLP Article 25 introduces the concept of “supplemental information” which is intended to incorporate additional labelling information over and above that listed in Article 17(a) to (g) and outlined above. This additional information can be divided into two categories, namely obligatory and non-obligatory information, and must be in the same language(s) as the CLP label elements.
Obligatory supplemental information
The label should include the relevant supplemental information when the substance or mixture that has been classified as hazardous has the physical or health properties described in Sections 1.1 and 1.2 of Annex II (Special Rules for the Labelling and Packaging of Certain Substances and Mixtures). These are essentially physical and health properties not included in UN GHS that are taken over from the 67/548/EEC Dangerous Substances Directive (DSD).
Similarly, where a mixture contains any substance classified as hazardous, it needs where applicable to be labelled in accordance with Part 2 of Annex II to CLP. These phrases have been taken over from the 1999/45/EC Dangerous Preparations Directive (DPD). For any supplemental statements included in CLP there are new “EU” codes to distinguish them from statements originating from the UN GHS.
These are alphanumeric codes consisting of EUH and three numerical digits and can refer to both hazard and other supplemental statements. Some examples are given in Table 4.
|EUH019||May form explosive peroxides.|
|EUH066||Repeated exposure may cause skin dryness or cracking.|
|EUH201||Contains lead. Should not be used on surfaces liable to be chewed or sucked by children.|
|EUH205||Contains epoxy constituents. May produce an allergic reaction.|
|EUH208||Contains (name of sensitising substance). May produce an allergic reaction.|
|EUH210||Safety Data Sheet available on request.|
Other obligatory supplemental information can include label elements resulting from other Community acts, for example relating to biocides, detergents, etc. These are described in more detail later in the article.
The supplemental information should be integrated with the CLP label elements, and should be easy to identify and read. It has precedence over any non-obligatory supplemental information if space on the label is limited.
Non-obligatory supplemental labelling
Suppliers may find the need to include certain elements on the label which are not legally obligatory but are necessary for the handling and use of the product. It can include, for example, specific product information or particular instructions for use.
This non-obligatory supplemental information may also be placed alongside the label elements required in CLP Article 17(a) to (g), and the obligatory supplemental information, when applied. However, it shall not distract from nor contradict the obligatory label elements, and must be consistent with the classification of the substance or mixture. This also implies the need to avoid inconsistent statements such as “non-toxic”.
Size of the label and label elements
The CLP Regulation (Section 1.2 of Annex I) defines the minimum dimensions on the size of the label and some of its elements. The minimum dimensions are taken over from the DSD, and are given in Table 5.
|Capacity of the package||Dimensions of the label (mm)||Dimensions of the pictogram (mm) (side length)|
|≤3 litres||If possible, at least 52 × 74||Not smaller than 10 × 10. If possible, at least 16 × 16|
|>3 litres but ≤50 litres||At least 74 × 105||At least 23 × 23|
|>50 litres but ≤500 litres||At least 105 × 148||At least 32 × 32|
|>500 litres||At least 148 × 210||At least 46 × 46|
Application of labels
Article 31 of CLP includes the stipulation that labels shall be firmly affixed to one or more surfaces of the packaging immediately containing the substance of mixture and shall be readable horizontally when the package is set down normally.
The labelling information can be displayed on the packaging itself rather than have a label.
Exemptions from the labelling and packaging requirements
Where substances or mixtures are supplied in packaging that is too small or of such form or shape that it is impossible to meet the requirements of Article 31, CLP provides for exemptions to labelling and packaging requirements. It should be noted that a packaging volume of 125ml or more cannot be considered as too small in this context.
Small pack sizes
The hazard and precautionary statements and pictogram that may be omitted for pack sizes under 125ml are set out in Section 1.5 to Annex I to CLP. Many of these provisions were brought over from DSD/DPD.
Regulation (EU) No 487/2013, the so called fourth adaptation to technical progress (ATP) of CLP, lays out further labelling derogations for packaging where the contents do not exceed 10ml.
Section 220.127.116.11 also specified the labelling exemptions of soluble packaging intended for single use where the content of each soluble package does not exceed 25ml.
Use of fold out labels, tie-on tags and outer packaging
In the situation where the packaging is so small or in such a shape or form that the full range of labelling elements even in a single language cannot be displayed and/or cannot be read horizontally when the package is set down normally, the label elements may be provided either on:
- fold-out labels
- tie-on tags, or
- outer packaging.
Section 1.5.1 of Annex 1 stipulates that where one of these alternatives is used, the part of the label which is attached to the packaging or, in relation to the last bullet point, the label on any inner packaging shall contain at least the hazard pictogram(s), the product identifier and the name and telephone number of the supplier.
It should be noted that these alternatives may not be used where a label becomes unreadable because the supplier has chosen to add more languages on a label than are required in the Member State where the substance or mixture is placed on the market.
Labelling shall be carried out on all layers of packaging, unless the layer is transparent (eg a clear film wrap) or otherwise allows (eg a cut-out) the label on the inner level of packaging to be seen. This includes the outer packaging, except as provided below.
Interaction between the CLP and the transport labelling rules
Article 33 of CLP sets out specific rules for situations where the packaging of substances and mixtures is required to meet also labelling provisions in accordance with the rules on the transport of dangerous goods.
A basic principle of CLP is not to override any labelling required by the transport rules while maintaining essential hazard information on the relevant layer(s) of packaging.
Transport “labelling” will have to appear on single or composite packages or the outer packaging of hazardous substances and mixtures if these are “dangerous goods” according to the rules on the transport of dangerous goods.
Single packages need to carry both the CLP label elements and the transport labelling, except for the CLP hazard pictograms where these are already covered by (an) equivalent transport pictogram(s) reflecting the same hazard.
CLP labelling will be required on every inner and intermediate packaging layer of a substance or mixture; CLP labelling may also appear on an outer packaging but this is not obligatory if those goods are carrying dangerous goods transport “labelling”.
“Labelling” here should be understood to include the Excepted Quantity package (EQ) and Limited Quantity package (LQ) marks as well as the transport Class danger labels.
Labelling requirements for other Community acts
Article 32(6) of CLP states that any labelling elements from other Community acts should be placed in the label section for supplemental information.
For example, the additional labelling elements required for biocidal products, detergents, and any labelling required by Authorisation and/or Restrictions under the REACH regulation should be included. A number of these are summarised below.
Biocidal products authorised under Regulation (EU) No. 528/2012 (BPR) must be classified, packaged and labelled in accordance with CLP (or DPD for mixtures up to 1 June 2015). However, there are significant additional labelling provisions.
These are specified in Article 69 of the BPR (which should be consulted for full details) and include the following.
- The identity of every active substance and its concentration in metric units.
- The nanomaterials contained in the product, if any.
- The authorisation number allocated to the biocidal product.
- The name and address of the authorisation holder.
- The type of formulation.
- The uses for which the biocidal product is authorised.
- Directions for use, frequency of application and dose rate.
- Particulars of likely direct or indirect adverse side effects and any directions for first aid.
- If accompanied by a leaflet, the sentence “Read attached instructions before use” and, where applicable, warnings for vulnerable groups.
- Directions for the safe disposal of the biocidal product and its packaging; including where relevant, any prohibition on the reuse of packaging.
- The formulation batch number or designation and the expiry date relevant to normal conditions of storage.
- Where applicable, the period of time needed for the biocidal effect, the interval to be observed between applications etc.
- Where applicable, the categories of users to which the biocidal product is restricted.
- Where applicable, information on any specific danger to the environment particularly concerning protection of non-target organisms and avoidance of contamination of water.
- For biocidal products containing micro-organisms, labelling requirements in accordance with Directive 2000/54/EC.
By way of derogation, where this is necessary because of the size or the function of the biocidal product, the information referred to in points (e), (g), (h), (i), (j), (k), (l) and (n) may be indicated on the packaging or on an accompanying leaflet integral to the packaging.
Article 11 of Regulation (EC) No. 648/2004, as amended by Regulation (EC) No. 1336/2008, specifies the labelling rules that apply to products that fall within the scope of the detergent regulations. In addition to the requirement to meet CLP/DPD labelling, certain additional information must appear on the label.
In particular Annex VII of Regulation (EC) No. 648/2004 specifies the additional labelling for contents that apply for detergents sold to the general public.
The following weight percentage ranges shall be used to indicate the content of a range of constituents where they are added in a concentration above 0.2 % by weight:
- less than 5%
- 5% or over but less than 15%
- 15% or over but less than 30%
- 30% and more.
These constituents include phosphates, surfactants, bleaching agents, hydrocarbons, soap, etc. For the full list consult Annex VII.
In addition the following constituents, if added, must be listed on the label irrespective of their concentration:
- optical brighteners
- preservation agents.
There are also requirements for listing certain allergenic fragrances if present above 0.01% by weight.
For detergents intended to be used in the industrial sector, and not made available to members of the general public, the above additional labelling requirements do not have to be fulfilled if the equivalent information is provided by means of technical data sheets, safety data sheets, or in a similar manner.
Article 65 of REACH provides that for substances that are subject to authorisation, the holders of the authorisation as well as downstream users including the substances in a mixture, must include the Authorisation Number on the label before they place the substance or the mixture on the market for an authorised use.
For most users of chemicals the product supply label is their first line of defence in understanding the nature and properties of the product they are intending to use, and the precautions they need to take.
Under CLP and with the additional labelling requirements of other legislation the amount of information required and the space taken up by the label elements has increased.
Furthermore, the “label” on a product, particularly consumer products for sale to the general public and also some trade products, can contain whole sets of other information that are not related to the hazards and safe use of the product. This can include company logos, marketing information, graphics and detailed information on the application and uses of the product.
There is always the risk that the regulatory information can be swamped by and not given anything like the prominence of this other information.
Producing the correct legally compliant label information is only half the battle. Presenting it well and in a manner that maximises the chances that it will be read and understood by the user is arguably as, if not more, important.
Those responsible for the regulatory information and product stewardship more generally, need if necessary to fight their corner with the other stakeholders within the organisation to ensure that the regulatory information is clearly and prominently displayed, is legible and is in the required language(s).
The regulations themselves provide some help in defining the standards that are required in terms of label size, legibility and content.
However, getting the user to read the label is an ongoing challenge for all involved in the sale of chemical (and other) products!
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