The Classification, Labelling and Packaging (CLP) Regulation is an implementation of the United Nations’ Globally Harmonised System (GHS). GHS provides a harmonised system for hazard classification, product labelling and other aspects, such as Safety Data Sheets (SDS), across all signatory regions and countries. GHS uses a building block approach allowing regions to adopt differing requirements into local legislation.
This approach has led to some complexity as needs can vary between jurisdictions. These harmonised provisions aim to have consistent product safety information and to improve protection for consumers, workplace users and the environment.
European Union (EU) CLP
Classification, Labelling and Packaging Regulation (EC) No 1272/2008 (CLP) is a European Union (EU) Regulation passed in 2008.
CLP regulation sets the same legally binding requirements across all Member States of the European Economic Area (EEA).
Great Britain (GB) CLP
The CLP regulation was ‘lifted and shifted’ into UK law after the United Kingdom (UK) left the European Union. Most of the legislation remained the same, but minor changes made it more appropriate to the GB market and facilitated the transition.
GB CLP applies to substances or mixtures placed on the market in GB (i.e. England, Scotland, Wales and associated islands). The Northern Ireland Protocol means that EU CLP applies to substances or mixtures placed on the market in Northern Ireland (NI).
What are the key principles of CLP?
CLP requires manufacturers, importers or downstream users of substances or mixtures to classify, label and package those products appropriately before placing them on the market. This requirement ensures that information on hazards is passed efficiently along the supply chain.
The first step is an assessment of the properties of a substance to determine its hazard profile. For example, the flashpoint of a substance may trigger classification as flammable, which then requires appropriate labelling; or, study data may trigger a human health hazard classification, which again would require specific labelling. The legislation sets the criteria and thresholds for each classification and category of severity.
A mixture is composed of two or more substances and is subject to the same requirements as the component substances. CLP specifies threshold levels for each hazard type above which that hazard must also apply to the mixture. Note that most of these thresholds should apply per component, and some are additive (meaning that actors should add all components with that hazard together). Many mixtures contain dozens or even hundreds of components, and specific software can facilitate calculations.
Labelling of a product allows clear hazard communication along the supply chain. Users of the substance or mixture are made aware of any hazards present and can implement whatever risk management measures are appropriate. The legislation sets out detailed requirements on labelling, including pictograms and wording, size of labels and legibility of any text, suitable packaging standards, and the layout and content of SDS, a critical element of the hazard communication process for workplace use.
An example of labelling
|Hazard class||The type of hazard.
For example: Flammable liquids.
|Hazard category||The severity of the hazard. For example: Flammable liquids hazard class divides into Categories 1, 2 and 3, with Category 1 being the most severe.|
|Pictogram||An image depicting the hazard. The image is displayed in black, on a white background, within a red diamond.
For example: The pictogram for Flammable liquids Categories 1-3 is GHS-02:
|Signal word||Accompanies other hazard information indicating a relative level of severity. There are two signal words; Danger and Warning. Note that Danger supersedes Warning.
If hazards dictate that Danger and Warning are required, only Danger must be displayed.
Examples of Danger:
Flammable liquids, Categories 1 & 2.
Serious eye damage/eye irritation, Category 1.
Examples of Warning:
Flammable liquids, Category 3.
Serious eye damage/eye irritation, Category 2.
Hazardous to the environment, chronic hazard, Category 1.
|Hazard statement||A brief statement on the nature of the hazard and its severity.
Flammable liquids, Categories 1 to 3 require the following hazards statements:
Category 1: Extremely flammable liquid and vapour.
Category 2: Highly flammable liquid and vapour.
Category 3: Flammable liquid and vapour.
|Precautionary statement||A statement describes recommended risk management measures relating to the appropriate hazard of the substance or mixture. While CLP is almost exclusively concerned with hazard, these precautionary statements deal with risk, i.e. reducing or preventing the hazard associated with use.
Flammable liquids hazard class requires many precautionary statements, such as;
P210: Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking.
P233: Keep container tightly closed.
P403+P235: Store in a well-ventilated place. Keep cool.
Safety Data Sheets (SDS)
The REACH regulation determines when an SDS is required, and CLP defines the format and content of SDSs. The SDS succinctly summarises the relevant information on a substance or mixture into a document that is easy to read and navigate for the user. The SDS is necessary for any substance or mixture classified with any hazard under the CLP classification regime. The manufacturer or distributor must provide an SDS free of charge no later than the first supply date.
The format of the SDS should be as follows:
- Identification (of the substance/mixture and the supplier);
- Hazard identification;
- Composition / information on ingredients;
- First-aid measures;
- Fire-fighting measures;
- Accidental release measures;
- Handling and storage;
- Exposure controls / personal protection;
- Physical and chemical properties (e.g. appearance / physical state, melting point, boiling point, flashpoint, solubility, vapour pressure);
- Stability and reactivity (e.g. conditions to avoid, hazardous decomposition products);
- Toxicological information;
- Ecological information;
- Disposal considerations;
- Transport information (e.g. UN TDG shipping and transport class and associated information);
- Regulatory information (compliance information not covered in other sections); and
- Other information.
The SDS should include a date of issue, version number and revision information. Annex II of the CLP Regulation sets out further details of SDS requirements.
While CLP is an EU Regulation, enforcement of its obligations is the responsibility of each EU Member State. National legislation applies regarding market surveillance of CLP compliance and penalties applying to non-compliance.
The enforcing authority for GB CLP, is the UK Health & Safety Executive (HSE). Non-compliance may lead to prosecution and unlimited fines or a prison sentence.
Certain types of products are exempt from the classification and labelling requirements of CLP, as they are subject to their own separate legislation of equal rigour.
- Medical devices
- Veterinary medicines
- Feeding stuffs (such as food additive; food flavouring; feeding stuffs used in animal nutrition)
A crucial distinction is that the final product as presented to the consumer is exempt, not the entire supply chain. For example, with a cosmetic product, CLP labelling is not necessary on the final pack placed on the store shelf; the stages of production and bulk material supply before this are in scope of CLP, however, and the requirements of hazard communication as laid out in the regulation do apply.
Harmonised Classification and Labelling
Annex VI of CLP lists substances that have a harmonised classification. Any Member State, manufacturer, importer or downstream user can propose a harmonised classification within the EU. It is for the European Chemicals Agency’s (ECHA) Committee for Risk Assessment (RAC) to assess these proposals. While this process can be used for any hazard, it is typically used for the most severe hazards (carcinogenicity, mutagenicity, reproductive toxicity and respiratory sensitisers). Once agreed and adopted, details of the harmonised classification are added to CLP Annex VI, which triggers additional requirements.
GB Mandatory Classification List (GB MCL)
The list of harmonised classifications in Annex VI of EU CLP was transposed directly into UK law when the UK left the EU. All harmonised classifications in force in EU CLP on that date (31st December 2020) have been retained in UK law, and this is referred to as the GB Mandatory Classification and Labelling List (GB MCL). The UK government has been transparent that further updates to Annex VI of EU CLP will not automatically be adopted into the GB MCL. This could lead to further divergence between EU and GB CLP.
The Classification and Labelling (C&L) Inventory is a database maintained by ECHA. Manufacturers and importers who place substances, on their own or in mixtures, on the market are obliged to submit notifications to ECHA with classification and labelling information. Notifications must be completed within one month of placing on the market. Substances in scope are:
- Substances classified as hazardous under CLP.
- Substances subject to registration requirements under the REACH Regulation 1907/2006 (note that entities holding a REACH registration for a given substance do not have to submit a notification to the C&L Inventory).
There is no equivalent to the C&L Inventory under GB CLP.
Poison Centre Notification (PCN)
Importers or downstream users placing mixtures with a human health hazard on the EU market must submit Poison Centre Notifications (PCN) to an organisation designated by the relevant Member State. Information requirements for these notifications are specified in Annex VIII to EU CLP. Submitted information is retained for access by national poison centres for emergency health responses, where it is critical to have fast access to clear information on hazardous mixtures. Depending on the Member State, actors may submit the notifications using ECHA’s submission portal or to the Member State directly.
An essential element of the submission is the unique formula identifier (UFI) displayed on the product label. This UFI code enables the link between the product and the relevant information.
Poison Centres under GB CLP
The National Poisons Information Service (NPIS), also referred to as the National Poison Centre, is the receiving submission authority under GB CLP. If you are a GB-based importer or downstream user of a hazardous mixture, information can be submitted to the NPIS via email in the form of an SDS. Submissions under GB CLP are a voluntary requirement. This also applies to NI-based entities directly supplying the GB market with qualifying NI Goods (QNIGs).
Other regional differences
The ‘building block’ nature of GHS and its adoption into legislation in different regions of the world mean that compliance in one region does not necessarily mean compliance in all, and care should be taken when marketing products across regions. For example, the Flammable liquids hazard class is divided into three categories in EU CLP and GB CLP; however, some regions (e.g. USA, China) also have a fourth category (where the flashpoint is >60°C and ≤93°C), requiring no pictogram but the signal word ‘Warning’. As a further example, GHS provides for three categories of acute environmental hazard, but EU CLP and GB CLP only use acute Category 1 for classification, and other regimes (e.g. USA, Canada, Australia) do not use any, acute or chronic.
How to comply with CLP?
Put simply, if you are responsible for placing a substance or mixture on the market within the EU or GB, and no exemption applies, you must:
- Classify your products using the classification scheme set out in the legislation (and following any harmonised or mandatory classifications);
- Label your products accordingly;
- Ensure that relevant information is passed along the supply chain in the form of an SDS; and
- Complete and submit any notifications required.
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