The CLP Regulation requires hazardous chemicals to be classified, labelled and packaged appropriately before they are placed on the market. The regulation is based on the United Nations’ Globally Harmonised System (GHS) and replaces in a stepwise manner the previous legislation – the Dangerous Substances Directive (DSD) and the Dangerous Preparations Directive (DPD). Now is the time to act to make sure that you comply with CLP
Re-label and re-package your mixtures
All hazardous chemicals must be labelled and packaged to comply with the CLP Regulation by 1 June 2015. However, there is a transitional period of two years for those mixtures that have already been classified, labelled and packaged under the DPD, and which are on the market before June next year. Such mixtures will only have to be labelled and packaged in accordance with CLP by 1 June 2017.
‘Placed on the market’ is a complex notion. In this particular case, it means that, on 1 June 2015, the mixture is no longer owned by the company that produced it – they have placed it on the market. For example, the mixture may still be in the formulator’s warehouse, but provided they have a proof of sale dated before 1 June 2015 to prove that they no longer are the owner, then they can benefit from the two year transition. Even if the classification and labelling are according to the DPD, the product can legally be sold for the coming two years. On the contrary, if the mixture is stored in the distributor’s warehouse, but is still owned by the formulator, then it must be re-labelled and re-packaged by 1 June 2015
Update the safety data sheet
The 2015 deadline also affects the safety data sheet (SDS) of your mixture. Until the deadline, your SDS must include the classification that follows the DPD. From 1 June 2015, the SDS no longer needs to contain the DPD classification, unless you still have mixtures already on the market as mentioned earlier. The contents of the SDS must match the information given on the label of your mixture.
You may already have the new classification together with the old DPD classification in your SDS. After the deadline for the CLP classification has passed, you should update your SDS and remove the old classification. You do not need to remove it straight away, but you can do it when the SDS is due for an update for other reasons. However, if the old classification affects the safe use of the product or its risk management measures, the SDS needs to be updated right away.
Classifying mixtures containing substances claimed confidential
Both the CLP and REACH Regulations make it possible for a supplier to claim their substance confidential. Under CLP, the supplier of a substance in a mixture can request an alternative chemical name for their substance. Alternative names granted under the DPD can also still be used under CLP. Under REACH, the registrant of a substance can claim the IUPAC name confidential and use the approved public name for the substance instead.
However, when the identity of the ingredient substances is not apparent, it may be difficult for a downstream user to decide on the appropriate classification for the mixture. Consequently, to guarantee the safe use of the substance and the subsequent mixture, the supplier must forward all relevant hazard information to the downstream user – even if the name of the substance has been claimed confidential.
Either the alternative name or public name must be given. If the substance is hazardous, the concentration range and classification must also be available to the downstream user.
Harmonised classification and labelling
Certain hazardous substances are subject to harmonised classification and labelling to ensure an adequate risk management across the European Union. These substances are listed in Annex VI to the CLP Regulation, and are also available in the Classification and Labelling Inventory. The list is continuously updated with new entries and amendments.
Sometimes your supplier may provide you with a classification that covers more hazard classes than the ones foreseen by the relevant entry in Annex VI to the CLP Regulation. This can be perfectly correct. Based on the CLP Regulation, the harmonised classification and labelling is legally binding and all the included hazard classes need to be applied to your classification. However, the supplier is responsible for evaluating all the relevant hazard classes and, if necessary, for adding a self-classification for any additional relevant hazard classes not covered by a harmonised classification and labelling. This means that, when classifying your mixture, you need to apply the full classification that you have received from your supplier, including both the harmonised classification and the possible self-classification.
Downstream user report may be needed
It is possible that in some cases you disagree with the classification that your supplier has provided. If any of your suppliers provide the same classification as yours, no action is needed. However, if you have only one supplier or you disagree with all of your suppliers, you need to generate a new classification and submit a downstream user report to ECHA. The report is created in IUCLID 5 format and submitted to ECHA through REACH-IT.
More information about the downstream user report and how to prepare and submit it can be found on ECHA’s website.