Classification, Labelling and Packaging (CLP)
Our first involvement in the harmonised EU criteria for classification, labelling and packaging was at the advent of the Dangerous Preparations Directive (DPD, 1999/45/EC), where our scientists managed the reclassification of many corporate portfolios. The Classification, Packaging and Labelling (CLP) Regulation No. 1272/2008 which entered into force on 20th January 2009 has replaced the DPD and Dangerous Substances Directive (67/548/EEC) in the EU, and implements the United Nations’ Globally Harmonised System of Classification and Labelling of Chemicals (UN GHS). The CLP labelling provisions take on board the red-framed hazard pictograms, signal words, and hazard and precautionary statements provided for in the UN GHS.
Since the 1st June 2015 the CLP Regulation has applied to chemical mixtures (formerly products/preparations), with respect to classification, labelling and packaging requirements. As with the previous legislation, the CLP Regulation is intended to be primarily a self-classification system for companies, using test data available on the mixture, bridging principles or the conventional calculation method.
We are competent to assist you in meeting your CLP obligations to:
- Gather and evaluate all relevant and reliable information on physical, health and environmental hazards
- Identify the relevant information for all relevant hazard classes/categories
- Evaluate against the CLP criteria to arrive at a suitable classification
- Liaise with competent authorities for submission of revised classification
- Prepare the revised product Safety Data Sheet (SDS)
- Prepare the revised product CLP label
CLP Desktop Companion
Our CLP desktop companion is now available and provides a handy reference guide to those parts of the regulation you are most likely to need daily. It’s not a replacement for the full text – and only documents published in the Official Journal of the European Union are deemed authentic – but should answer your day-to-day questions on classification and labelling.
We would welcome your feedback and comments on this edition and any suggestions you may have as to how future editions can be enhanced.
Safety Data Sheet Preparation
Safety data sheets (SDSs) provide useful information on substances and chemical mixtures, describing the hazards presented, and giving information on handling, storage and measures in the case of an accident or emergency. An SDS must be supplied with hazardous substances, and with mixtures containing hazardous substances above thresholds of concern. EU SDSs must be prepared in accordance with the format prescribed in Annex II of the REACH Regulation (Regulation (EC) No 1907/2006), as updated by the Regulation (EU) No 453/2010. Over the years there has been a gradual transition to the extended SDS (eSDS) which includes further information on safe handling, in the form of exposure scenarios. REACH requires users of hazardous chemicals to follow the advice on risk management measures given in the exposure scenario.
For the EU, it is a requirement that the person responsible for compiling an SDS is ‘competent’, that is, that they have the relevant experience, knowledge and training. Our experts provide EU SDS compilation and translation services for our clients.
Poison Centre Notification
Generally, chemical products are considered to be safe if their use instructions are followed. However, inappropriate use or accidents can cause unintentional exposure and, in this case, immediate access to relevant information on the chemical product is crucial for medical staff and emergency responders.
In order to have this information readily available, the CLP Regulation (EC) No 1272/2008, incorporated in Art 45 the requirement for MS to appoint a body for receiving information on the composition of hazardous mixtures. However, the absence of harmonisation led to inconsistencies in the information available in different MS. To address this issue a new Annex VIII entered into force in April 2017, setting provisions for the harmonisation of the format and content of the information to be submitted to the MS appointed bodies or poison centres.
The required information includes product identification, hazard identification, product composition and the intended uses. The information must be submitted by electronic means in a specified format. A unique formula identifier (UFI) will allow the poison centres to unambiguously identify the composition of the mixture and propose the appropriate medical treatment in the event of poisoning. The deadlines for submitting the information are:
– 1 January 2021 for mixtures for consumer or professional use
– 1 January 2024 for mixtures for industrial use
If the information has already been submitted before the date of applicability, a resubmission is not required until 1 January 2025.
The obligation for the submission falls on companies carrying out import, formulation, repackaging, refilling and/or toll formulation activities. Distribution, retail, re-branding and/or re-labelling activities may require submission under certain circumstances.
Post submission, submitters must make sure that the submitted information is constantly up to date.
We can assist you with:
- ensuring you meet your obligations for appointed body/poison centre notification
- carrying out required submissions through the relevant online submission tools (e.g. IUCLID)
- generating UFI(s)
- keeping your submission up to date
If you require assistance with CLP or SDS preparation, please send an email to info@kerona.ie or contact our team on +353 1 849 5284.