A wide variety of chemical products are available on the EU market for use by professionals and the general public. These products can pose hazards due to unintentional exposure in cases of misuse or accidents. It is crucial that emergency responders have immediate access to accurate and relevant information about the chemical product in question when an accidental exposure takes place.
According to Article 45 of the CLP (Regulation (EC) No 1272/2008 on the classification, labelling and packaging of substances and mixtures), importers and downstream users placing hazardous mixtures on the market are responsible for complying with the requirements established in Annex VIII to the CLP. According to Annex VIII, information must be submitted for mixtures that are placed on the EU market and classified as hazards based on their health or physical effects. Required information must be provided to the appropriate appointed body in the Member States where the mixture is placed on the market. Submission information includes the GHS hazard classification, toxicological information, as well as information about the composition of the product.
Poison centres have reported experiencing problems correctly identifying a mixture in case of accidental exposure in up to 40% of the calls they receive. In order to improve emergency response, labels for hazardous mixtures placed on the market will be required to carry a 16-digit Unique Formula Identifier (UFI). The UFI will enable rapid and unambiguous identification of the information submitted on the mixture by any poison centre called upon to provide advice on dealing with a poisoning incident.
Version 1.0 of the Guidance on harmonised information relating to emergency health response is available on the Guidance on CLP section on ECHA’s website.
If you have obligations under Annex VIII to CLP, we recommend downloading a copy of the ECHA Guidance document which provides details on the obligation to submit relevant information on hazardous mixtures to the Member States’ appointed bodies.
ECHA Submission portal now available
The first release of the ECHA submission portal is now available for poison centre notifications. The portal is a secure way to centrally manage notifications for hazardous mixtures and is available for use by industry and Member States’ appointed bodies.
Member state variation in implementation
Notification is not currently a one size fits all solution. Member states have implemented the appointed bodies in different ways and have different requirements for submission. In many cases, submission is free, whereas some countries charge a fee for submission. Several countries accept notification vie the ECHA Submission Portal only, whereas others have a national system for submission. Additionally, most countries require notification to be in the local language.
Benefits of notifying now
The deadline for compliance with Annex VIII is 1 January 2020 for consumer mixtures, 1 January 2021 for professional mixtures, and 1 January 2024 for industrial mixtures.
It’s a good idea to notify soon rather than waiting until the deadline for several reasons. Companies have moral obligation to submit the relevant information so that in the case of an accident, the required information is available to emergency responders. Notification is currently free in most member states and it is unclear if the fees will change in the future. Additionally, companies that notify before the deadline may take advantage of the transitional period. Before the deadlines, mixtures continue to be subject to existing national requirements. If the relevant information relating to a hazardous mixture, according to the national requirements, is submitted to the appointed body for the deadline, there is no obligation to comply with Annex VIII until 1 January 2025. This means that less information is required for notification and the UFI does not need to appear on the label until the year 2025. However, if there is a change in the mixture composition, product identifier, or toxicological properties during the transitional period, then a submission in accordance with Annex VIII is required before the product may be placed on the market.
A list of national appointed bodies is available at the ECHA Poison Centre website: https://poisoncentres.echa.europa.eu/
For more information about EU poison centre notification, contact Nexreg today!