On 13 November 2020, the second amendment to Annex VIII of the Classification, Labelling and Packaging (CLP) Regulation was published. The purpose of this amendment is to provide clarity on the workability concerns raised by specific industry sectors – namely the construction, paints and petroleum industries.
Concerns expressed by these industries contained a common theme – the unpredictability and variability of product composition. Many industry sectors face the challenge of not knowing the exact composition of mixtures in cases where raw materials with a highly variable or even unknown composition are used. Other notable concerns that have been raised, include cases where:
- Very toxicologically similar components are supplied by multiple suppliers and used together in the same production line.
- Complex supply chains are used.
A specific concern raised by the bespoke mixture industries was the impossibility of knowing in advance, or even predicting, which exact bespoke mixtures of the infinite possible combinations would be placed on the market.
Solutions were developed to address the issues and reduce the difficulty faced by duty holders to comply with regulations, while still requiring enough information for poison centres to provide effective emergency health response.
Therefore, the second amendment provides:
- Cross-sector solutions for unpredictability of compositions.
- Relaxed requirements for construction products and fuels.
- An exemption for bespoke paints.
- Introduction of Interchangeable Component Groups and Standard Formulas.
Interchangeable Component Groups (ICG)
ICGs were introduced with the intention of providing a more general solution to the workability concerns. More specifically, they were introduced to address situations where different, but toxicologically very similar, components are used in a mixture and where it is unknown which component is present in a particular mixture placed on the market at a given time.
Therefore, downstream users and importers can group toxicologically similar components together in an ICG and provide information on the total concentration of those components present in the mixture, without the need to specify their individual concentrations.
For all components in an ICG, the following criteria in its entirety must be met:
- The technical functions for which the components are used in the mixture, for which the submission is made, are identical.
- The classification for health and physical hazards is identical (this includes hazard class and category).
- The toxicological profile, including at least the type of toxicological effects and the target organs, are the same.
In the ECHA’s Annex VIII harmonised submission portal, ICG components can be flagged by the submitter.
Standard Formulas and the construction industry
A concern raised by the construction industry was the inability to predict exact composition due to the high variability of composition in raw materials, often resulting in concentrations out of the allowable ranges under Annex VIII. This inability spread over different time periods and consequently the failure to notify following the original standard requirements, would lead to duty holders having to complete multiple notifications, create multiple unique formula identifiers (UFIs) and frequently update their notifications.
To address these difficulties and to enable compliance with the emergency health response requirements, Annex VIII now contains a new section, Part D, which includes an exhaustive list of Standard Formulas. Each Standard Formula outlines the components and their compositions. Therefore, a mixture with a composition conforming to a Standard Formula specified in Part D can be notified with reference to the relevant standard composition. The list applies to the gypsum, ready-mixed concrete and cement sectors.
However, when completing a notification using a specific Standard Formula, there are requirements that need to be met.
Standard Formulas can only be used in cases where the mixture classification does not change according to the mixture’s composition and stays within the concentration ranges specified in the Standard Formula. Moreover, the information on composition in the Standard Formula must be at least as detailed as the information contained in the mixture’s safety data sheet (SDS).
In the ECHA’s Annex VIII harmonised submission portal, specific components that conform to Standard Formulas can be flagged by the submitter.
The workability solutions introduced for the fuels industry are similar to those outlined for construction products.
Concerns raised by the fuels industry highlighted the difficulty in knowing the exact concentration of all batches at various points in time. Furthermore, the variability in the composition of raw materials, often results in concentrations out of the allowable ranges or even unknown concentrations.
Therefore, for fuels listed in Table 3 of Annex VIII, the workability solution added that the identity and concentration of the mixture’s components listed in the SDS may be submitted, along with any other known information on the product’s chemical composition. Therefore, it is possible to waive the stricter information requirements of Annex VIII.
In the ECHA’s Annex VIII harmonised submission portal, fuels will be considered a Standard Formula, enabling the exact name of the fuel to be flagged. The rules for fuels will differ from those of Standard Formulas.
Bespoke paints could have an unlimited number of compositions, requiring an extremely large number of different notifications and UFIs to be created for every possible combination to comply with the regulation. The other option was to delay supply until the information had been submitted to the harmonised portal and the UFI had been created. Either approach would have placed a disproportionate burden on the bespoke paints industry.
Due to the relatively small number of accidents related to paints being reported by poison centres and the lower risk compared with other mixtures, the Annex VIII second amendment now states that submitters may opt not to submit information and not create a UFI.
A set definition of bespoke paints is now included in the Annex VIII second amendment, which is as follows:
‘A paint that is formulated in limited amounts on a tailor-made basis for an individual consumer or professional user at the point of sale by tinting or colour mixing.’
However, the base paint and other mixtures contained in the bespoke paint remain subject to all requirements of Annex VIII and must be notified. Additionally, the final bespoke paint’s label must include the:
- UFI of the base paint.
- UFI of all the individual mixtures contained in the bespoke paint.
- Specific concentration of each mixture present within a UFI (for concentrations exceeding 5%).
How can NCEC help my organisation with Annex VIII notifications?
NCEC recently hosted a poison centres event focused on Annex VIII and were joined by multiple Member States. The event covered:
- IT tools.
- Compiling information.
- Workability solutions for industries with variable formulas.
- Different EU country’s adoption of the harmonised submission portal.
- Brexit and Annex VIII's implementation across non-European regions.
If you would like to purchase the recording, please fill the form here. This would also give you access to the many questions that were answered during the event and a subsequent frequently asked questions sheet that our experts have developed.
If you need any further assistance in understanding Annex VIII or the amendments, what it could mean for your UK or EU-based organisation, or require help for your poison centre notifications, then please don’t hesitate to contact us through the form on the side, call us at +44 (0)1235 753654 or email us at [email protected].