CLP
Section outline
-
A. Introduction
CLP (Regulation (EC) 1272/2008) is the acronym for Classification, Labelling and Packaging of substances and mixtures. This Regulation entered into force on the 20th of January 2009 and is based on the Globally Harmonized System (GHS), a set of recommendations drafted by the United Nations.
Aim
The purpose of the CLP regulation is to clearly communicate chemical hazards to workers and consumers across the European Union by classifying and labelling chemicals appropriately.
The primary goal of CLP is to protect human health and the environment. All parties involved in the supply chain are responsible for complying with the classification, labelling and packaging rules. Before chemical products enter the market, manufacturers and suppliers must assess the potential risks these substances and mixtures pose to people and the environment and classify them based on their identified hazards. Hazardous chemicals must be labelled using a standardised system to ensure that workers and consumers understand the risks before use.
Moreover, CLP is closely connected with:
- REACH, especially in relation to safety data sheets;
- Various other European regulations, including those on Biocides, Plant Protection Products, major industrial accident prevention (Seveso Directive), and workplace chemical safety (Carcinogens and Mutagens Directive, Chemicals Agents Directive).
Scope
CLP requirements apply to chemical substances (such as chloric acid, ethanol, iron, cooking salt, ammonia, bleach...) as well as to mixtures (detergents, paints, lacquers, concrete, oil...).
The CLP Regulation does not apply to certain categories such as radioactive substances, waste, non-isolated intermediates, substances under customs supervision, and materials used for scientific research and development. It also excludes finished products intended for end users, including medicinal and veterinary products, cosmetics, medical devices, and food or animal feed products regulated under other EU legislation.
In this section we will mainly focus on the C&L inventory. Visit ECHA’s webpage for further information and guidance on the CLP regulation.
Classification
All substances which are placed on the EU market must be classified by manufacturers, importers or downstream users of chemical substances or mixtures according to Article 4.1 CLP. This obligation applies regardless of the tonnage manufactured, imported or placed on the market.
Besides the obligation to classify under the CLP Regulation, manufacturers and importers must also classify all substances subject to registration and notification obligations under the REACH Regulation (Articles 6, 7, 9, 17 and 18 REACH).
There are two types of classification:
- Harmonised classification: This type of classification concerns substances for which a classification has been decided upon at the European level. When a harmonised classification and labelling exist, companies must apply this classification. Harmonised classifications can be found in the tables of Annex VI CLP. A harmonised classification only applies to substances and not to mixtures.
- Self-classification: This type of classification is required when substances do not have a harmonised classification or where a harmonised classification only covers certain hazard classes. The self-classification has to be done by: manufacturers of substances, importers of substances or mixtures and downstream users, including formulators.
Further detailed information and guidance can be found ECHA’s webpage on classification.
Labelling
The label is the main source of information on the hazards of chemicals that can be accessed by users who may be workers but also consumers. Labelling ensures that the characteristics of a given product are clearly visible and accessible. These labels help the user to be aware of any specific hazards as well as necessary precautions which need to be taken when using a product.
Suppliers or importers of a substance or mixture are required to label the product if this product is classified as hazardous. In addition, if a mixture contains at least one substance that is classified as hazardous, the product must be labelled as well.
According to Article 17 CLP, a substance or a mixture classified as hazardous must bear a label including the following elements:
- Name, address, and telephone number of the supplier(s);
- The nominal quantity of the substance or mixture in the package where this is being made available to the general public, unless this quantity is specified elsewhere on the package;
- Product identifiers;
- Hazard pictograms, where applicable;
- The relevant signal word, where applicable;
- Hazard statements, where applicable;
- Appropriate precautionary statements, where applicable;
- A section for supplemental information, where applicable.
Further detailed information and guidance can be found on ECHA’s webpage on labelling.
B. Classification and labelling (C&L) inventory
The Classification and Labelling (C&L) inventory is a database maintained by ECHA that contains information on the classification and labelling of substances placed on the European market. It includes data on both notified and registered substances, as well as the list of harmonised classifications and labelling specified in Annex VI of the CLP Regulation.
C&L notification
Within the framework of the C&L inventory, manufacturers and importers are required to notify the classification of all substances placed on the market.
A notification to ECHA must be submitted when:
- substances are manufactured and/or imported and are subject to registration under the REACH Regulation;
- substances are classified as hazardous;
- mixtures contain a hazardous substance present above the relevant concentration limit, causing the mixture itself to be classified as hazardous;
- articles contain a substance that is subject to registration according to Article 7 of the REACH Regulation.
The notification must be made within one month of placing the substance on the market. For importers, this one-month period begins from the date the substance, either on its own or within a mixture, is physically brought into the territory of the European Union.
Note:
- There are no exemptions from C&L notification requirements. Therefore, even substances exempt under the REACH Regulation must be notified.
- If a manufacturer or importer has already submitted a registration dossier under REACH for a substance, a separate C&L notification is not required since the necessary classification and labelling information is already included in the registration dossier.
How to notify
C&L notifications must be submitted electronically through the REACH-IT portal on the ECHA website. There are three submission methods available:
- Directly online using REACH-IT;
- Creating an IUCLID dossier and submitting the notification via REACH-IT;
- Uploading a bulk notification as an XML file through REACH-IT.
Information in the C&L inventory
The following information is published according to CLP (Article 42):
- The name in the IUPAC nomenclature for substances classified with certain hazard classes or categories set out in Article 119(1)(a), without prejudice to Article 119(2)(f) and (g) of REACH;
- The name of the substance as given in EINECS, if applicable, and other numerical identifiers as appropriate and available;
- The classification and labelling of the substance.
All notifications for any published substance are included in the C&L Inventory and this includes notifications for non-classified substances.
More information and guidance concerning C&L notifications can be found on ECHA’s website.