The requirement to submit information to poison centres is not a new one. Indeed, the requirement to provide information on hazardous mixtures to poison centres has been around since the 1999 Dangerous Preparations Directive, and was transposed into CLP (via Article 45) in 2008.
Because the original requirement was based on a Directive, each Member State implemented the requirement in their own way, leading to different notification systems across the EU. Therefore, at the time of introducing CLP, the European Commission agreed to undertake a review of these requirements to see if harmonisation of notification requirements across the EU would be beneficial.This review was duly undertaken and led to the introduction of Regulation (EU) 2017/542, amending CLP by adding an annex on harmonised information relating to emergency health response (Annex VIII).
The new Annex VIII requires information for poison centres to be submitted using a new harmonised format. In addition, it requires that suppliers create new Unique Formula Identifier (UFI) for each hazardous mixture that they place on the market, to be included on labels and safety data sheets as specified in the regulation.
Notifications for new hazardous mixtures being placed on the market, and updates to existing hazardous mixture notifications, must be made in the new format from
- 1 January 2021 for hazardous mixtures supplied to consumers (delayed from 1 Jan 2020)
- 1 January 2021 for hazardous mixtures supplied to professional users
- 1 January 2024 for hazardous mixtures supplied to industrial users.
All existing notifications need to be updated to the new format by 1 January 2025, if they have not already been done so as above.
Many suppliers who have not previously notified their hazardous mixtures to poison centres are waiting for the new systems to be put in place before making their notifications by the above deadlines. Whilst this may be acceptable in some EU Member States, particularly those who set up voluntary notification systems, this is not the case in all Member States, many of whom did fully enact the requirements of the DPD and CLP. Suppliers should check the requirements for each Member State where they place mixtures on the market, and make notifications as required. Information about existing national schemes can be found on the ECHA website via the list of National Helpdesks. This also includes information on whether an emergency telephone number needs to be added to section 1.4 of the SDS.
The new format for making notifications requires suppliers to provide detailed information on their product, including:
- Product identifiers, including the new UFI
- Hazard classification and labelling of the mixture
- Either exact percentage composition, or composition ranges. If using composition ranges, suppliers must be within specified ranges which depend on the hazard of the ingredient, and are much narrower than those typically used on Safety Data Sheets
- Details on physical form, pH, packaging, etc.
- Information on toxicological properties
- Use information using a new product categorisation system
These requirements apply to all mixtures placed on the market that are classified for either physical hazards or health hazards. The new requirements do not apply to mixtures classified only for hazards to the environment.
Mixtures which are outside the scope of CLP, e.g. foods and feedstuffs, medicines and cosmetics in their retail packaging are also exempt, though it should be noted that for, e.g., bulk mixtures which are not yet in their final packaging and are still subject to CLP, notification would still be required. In this case, the industrial mixtures deadline would apply as there are separate notification requirements under other sectoral legislation for the retail products.
There are also exemptions for mixtures that meet the definition of “scientific research and development” and to mixtures for “product and process oriented research and development”. Mixtures classified only as gases under pressure; and/or explosives (unstable explosives and Divisions 1.1 to 1.6) are also exempted.
Products supplied only for industrial use can also benefit from reduced notification requirements (an SDS can be submitted instead of detailed compositional information) but only where the supplier can provide the full information required 24/7. If this is not possible, a full notification must be submitted.
There has been a lot of discussion over what is an industrial mixture. A mixture is only considered to be an industrial mixture if all uses, including down the supply chain, are industrial. A fragrance blend that goes into a household cleaning product, for example, would not be considered to be an industrial mixture, even though the immediate customers of the supplier may be using it at an industrial site to create the household cleaning product.
A new, central submission portal has been created by ECHA to make it easier for companies to make their notifications. An overview of which countries are accepting submissions through the portal, what languages they accept, and whether a fee may be charged for submissions is also available.
Further information on the new requirements, including tools and guidance can be found on the ECHA website here.
GB Requirements
Since the first transition deadline for making notifications in the new format was after the date of the UK’s withdrawal from the EU, and since the UK had always adopted a voluntary system based on submission of SDS, it had been understood that the new EU Poison Centre Notification requirements would not be adopted in GB (Northern Ireland, however, remains within EU CLP as part of the NI Protocol and notifications are required).
However, it has since transpired that the EU legislation implementing the new requirements was actually adopted into UK law as part of the withdrawal arrangements. The UK government is currently considering whether to retain these requirements or to introduce new legislation that would repeal them. In the meantime, companies may wish to consider making voluntary submissions to the UK National Poisons Information Service (NPIS), either in the new format, or by submitting their SDS, as under the previous arrangements.