CLP regulation compliance
CLP Regulation (Classification, Labelling and Packaging) is a European Union legislation introduced in 2008 that applies to the European Economic Area (EEA). The regulation is the European Union system of classification, labelling and packaging of chemical substances and adopts the Globally Harmonised System (GHS). The GHS is a non-legally binding international agreement, set up by the United Nations, for classifying and communicating the hazardous properties of industrial and consumer chemicals. GHS replaced a variety of regulations used around the world.
What are the CLP requirements?
CLP requires all importers, manufacturers and downstream users to classify, label and package substances and mixtures adequately before they can be placed on the market. TSG can help to determine your company’s CLP requirements for chemical substances and mixtures within the EEA.
The aim of classification is to ensure all substances and mixtures that feature hazardous properties are correctly identified. To comply with this, companies must determine the classification of substances and mixtures before they are placed on the market.
Self-classification involves reviewing information on the physical, health, environmental or other hazards, and comparing them with the criteria set out in the CLP regulation. Many common substances have a harmonised classification, listed in CLP Annex VI, and must be classified accordingly, as a minimum.
TSG’s team of regulatory and toxicological experts can help you to review information related to your substance or mixture and derive the classification.
Once a substance or mixture has been classified, any risks need to be communicated to your customers effectively. In addition, manufacturers and importers of certain articles must communicate identified hazards to other actors in the supply chain. This is done by labelling, and CLP defines the content of a label and the layout of various label elements. In addition, there may be additional packaging requirements such as child-resistant fastenings or tactile warnings of danger (TWD).
TSG can help to identify all labelling requirements required by the CLP regulation.
Notifications to the C&L Inventory
Importers and manufacturers of certain substances, mixtures and articles must submit a notification to the Classification and Labelling Inventory within one month from them being placed on the market. Notifications must follow a specific format and should be submitted by importers, manufacturers, Only Representatives or third parties.
TSG can help to create and submit notifications to the C&L Inventory.
Poison centre notifications
A new Annex was added to the CLP Regulation in 2017, which requires importers and downstream users to submit harmonised information on mixtures they place on the market which are classified for any health or physical hazard. This information has to be submitted to the appointed bodies (the Poison Centres) in every Member State in which the mixture is sold, and is used in an emergency health response.
TSG can help you to prepare and submit the necessary notifications to Poison centres throughout the EEA.
Safety Data Sheets
Regulation (EC) No 1907/2006 (REACH) requires Safety Data Sheets (SDS) to be supplied to professional customers in order to convey CLP information about the substance or mixture. SDSs are required for substances or mixtures classified as: hazardous under CLP, or persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), or if a substance is included on the REACH candidate list, or if a number of other criteria apply. The SDS follows an internationally-agreed 16 section standard format and must be supplied in the official language of the Member State(s) where the substance or mixture is placed on the market, unless the Member State(s) concerned provide(s) otherwise.
Importantly if a substance is manufactured or imported into the EEA at >10 tonnes/year and the substance is classified as hazardous under CLP, an extended SDS (eSDS) should be prepared and supplied to customers. This contains an additional annex with one or more exposure scenario(s).
TSG can help prepare CLP-compliant SDSs & eSDSs.
Substances registered as active substances under EU pesticide or biocide regulations, or those classified under CLP as carcinogenic, mutagenic or toxic to reproduction (CMR) require a CLH dossier be prepared and submitted to ECHA for evaluation. Using available scientific data, a CLH dossier must review the physical, health, environmental and other hazards of the substance to derive/justify the CLP classification/non-classification. A CLH dossier is normally submitted by the Member State/Competent Authority, but is often prepared by the substance registrant or supplier.
With extensive experience through our dedicated EU pesticide and biocide regulatory teams, supported by technical specialists and chemical expertise, TSG can assist preparing and submitting CLH dossiers.