Two regulations amending Annex VI to the CLP, Regulations 2023/1434 and 2023/1435, were published in the Official Journal on 11 July and enter into force on 31 July 2023.
amends Annex VI to CLP by revising the harmonised classifications of compounds of boron on the one hand and 2-ethylhexanoic acid (2-EHA) and its salts on the other hand. Those New classifications will be applicable from 1 February 2025.
creates new notes in connection with these entries:
Notes 11 and 12 relating to the additivity of the hazard for reproductive toxicity:
o Note 11 specific to Borates,
o Note 12 applicable to 2-EHA and likely to be attributed, in the future, to substances others ; it is worded so that it is not limited to the entry of 2-EHA,
o They specify that the classification of mixtures as toxic for reproduction is necessary when the sum of the concentrations of the different substances in the mixture placed on the market is equal to or greater than 0.3%.
Note X (applicable to 2-EHA but likely to be assigned to others in the future).
It specifies that the classification is only based on the hazardous properties of the structural part common to substances. The substances covered by this note must therefore be self-classified to take into account the dangers associated with other structural elements.
COMMISSION DELEGATED REGULATION (EU) 2023/1434 of 25 April 2023 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards the addition of notes to Part 1, section 1.1.3, of Annex VI
Commission Delegated Regulation (EU) 2023/1435 of 2 May 2023 amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures as regards the modification of entries in Part 3 of Annex VI for 2-ethylhexanoic acid and its salts, boric acid, diboron trioxide, tetraboron disodium heptaoxide hydrate, disodium tetraborate anhydrous, orthoboric acid sodium salt, disodium tetraborate decahydrate, and disodium tetraborate pentahydrate
The compliance date for industrial use only mixtures, focusing on the second poison centre compliance date set for January 2024.
Industrial use only mixtures – the transitional period, information requirements, the use of Unique Formula Identifier (UFI), and available tools and support for compliance.
Industrial Use Only Mixtures: These mixtures are exclusively used in industrial sites and are not accessible to consumer or professional users as a final product or in diluted form. For example, an automotive paint used only at an industrial site is an industrial use only mixture.
Transitional Period: Industrial use only mixtures already notified via national submission systems before the 2024 compliance date may benefit from a transitional period until January 1, 2025. However, any modifications made to the mixture’s composition, product identifiers, classification, or toxicological information during this period require a harmonized format notification before market introduction.
Information Requirements: The harmonized information requirements include full chemical composition, toxicological information, product details, and the Unique Formula Identifier (UFI) as outlined in Annex VIII to the CLP Regulation.
Limited Submission for Industrial Use Mixtures: Industrial use mixtures have the option of a “limited submission” where compositional information from the Safety Data Sheet can be used. However, a contact person providing complete compositional details in case of an incident must be included in the notification.
UFI in Notification and Labeling: Hazardous mixtures requiring notification must have a UFI in both the Poison Centre Notification (PCN) and on the product label. If a hazardous mixture is exclusively used at an industrial site, the UFI may be indicated only in Section 1.1 of the Safety Data Sheet. If the same mixture is available to consumer or professional users, the UFI is required on the label.
Main Use from EuPCS: The main intended use of a mixture is identified by selecting the most relevant category from the European Product Categorization System (EuPCS). Secondary uses may also be included if applicable. For any difficulties in assigning a product category, industry associations or the helpdesk can provide recommendations or assistance in requesting a change to the EuPCS.
The upcoming compliance date of January 2024 for industrial use only mixtures necessitates adherence to harmonized information requirements outlined in Annex VIII to the CLP Regulation. Companies must ensure compliance and utilize available tools and support to facilitate successful notification. The report emphasizes the distinction between industrial use only mixtures and industrial use mixtures, the transitional period, the role of UFIs, and the need for accurate product categorization as per the EuPCS.