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CLP Regulation
CLP (Classification, Labelling & Packaging)
The CLP (Classification, Labeling and Packaging) Regulation is European Union legislation introduced in 2008 that applies to
the European Economic Area (EEA). The regulation constitutes
the European Union's system of classification, labeling and packaging of chemical substances and adopts the Global Harmonized System (GHS). The GHS is a non-legally binding international agreement established by the United Nations
to classify and report the hazardous properties of industrial
and consumer chemicals. The GHS replaced a number of
regulations used around the world.
The CLP requires all importers, manufacturers and downstream users to properly classify, label and package substances and mixtures before they can be placed on the market. Pharmilab can help determine your company's CLP requirements for chemical substances and mixtures in the EU.
Classification
The objective of classification is to ensure that all substances and mixtures that present dangerous properties are correctly identified. To achieve this objective, companies must determine the classification of substances and mixtures before they are placed on the market.
Self-classification involves analyzing information about physical, health, environmental or other hazards and comparing it with the criteria defined in the CLP Regulation. Many common substances have a harmonized classification, listed in Annex VI of the CLP Regulation, and must be classified, as a minimum, accordingly.
Pharmilab's team of regulatory and toxicology experts can help you analyze information related to your substance or mixture and obtain its classification.
Labeling
Once a substance or mixture has been classified, any risks must be communicated to your customers effectively. Furthermore, manufacturers and importers of certain items must communicate identified hazards to other actors in the supply chain. This is done through labeling and the CLP Regulation defines the content of a label and the arrangement of the various elements of the label. Additionally, there may be additional packaging requirements, such as child safety locks or tactile hazard warnings (TWD).
Notifications for Classification and Labeling Inventory
Importers and manufacturers of certain substances, mixtures and articles must submit a notification to the Classification and Labeling Inventory within one month of placing them on the market. Notifications must follow a specific format and must be submitted by importers, manufacturers, sole representatives or third parties.
Pharmilab can help create and submit Classification and Labeling Inventory notifications.
Poison Center Notifications
In 2017, a new annex to the CLP Regulation was added, which requires importers and downstream users to submit harmonized information on mixtures they place on the market that are classified for any health or physical hazard. This information must be submitted to designated bodies (Poison Centers) in all Member States where the mixture is sold and used in a health emergency response.
Safety Data Sheets
Regulation (EC) No. 1907/2006 (REACH) requires that safety data sheets (SDS) be provided to professional customers to convey CLP information about the substance or mixture. SDS are required for substances or mixtures classified as: dangerous under the CLP Regulation, or persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), or if a substance is included in the REACH candidate list , or if several other criteria apply. The SDS follows an internationally agreed standard 16-section format and must be provided in the official language of the Member State(s) in which the substance or mixture is placed on the market, unless otherwise provided by the ) Member State(s) concerned.
It is important to note that if a substance is manufactured or imported into the EEA in quantities exceeding 10 tonnes/year and if the substance is classified as dangerous under the CLP Regulation, an extended SDS (FDSe) must be drawn up and provided to customers. This contains an additional annex with one or more exposure scenarios.
CLH Dossiers
Substances registered as active substances under EU pesticide or biocide regulations, or those classified under the CLP Regulation as carcinogenic, mutagenic or toxic for reproduction (CMR), require the preparation of a CLH dossier and its submission to ECHA for assessment. Using available scientific data, a CLH dossier should analyze the physical, health, environmental and other hazards of the substance to derive/justify CLP Regulation classification/non-classification. A CLH dossier is normally submitted by the Member State/Competent Authority, but is often prepared by the registrant or supplier of the substance.
In addition to services typically applied to cosmetic products, Pharmilab can help you with many other processes and regulatory obligations:
REACH
Assessment, dossier update, compliance check, restriction
Notifications
Poison centers, SVHC in articles or Prior Informed Consent (PIC)
CLP classification and MSDS creation
Labeling
Brexit management
Other EU services
