by Charlotte Blackburn, PhD
The first amendment to Annex VIII to CLP, relating to the harmonisation of EU Poison Centre information requirements, was published in the Official Journal on 10th January 2020. The most significant change is the postponement of the first compliance deadline for mixtures placed on the market for consumer use to 1st January 2021, which replaces the original deadline of 1st January 2020. There has been no change to the deadlines for mixtures placed on the market for professional use (1st January 2021) and industrial use (1st January 2024).
A number of workability issues relating to Annex VIII requirements have been raised, such as dealing with the impact of multiple suppliers of technically equivalent raw materials. The deferral of the first deadline by one year should allow time for necessary solutions to be developed and any resulting changes to the new rules made.
What other changes have come in?
Along with the postponement of the first compliance deadline, some other key changes have been made which include:
- The regulation previously stated that the Unique Formula Identifier (UFI) shall be printed or affixed on the label, but has been amended so that the UFI can now alternatively be printed or affixed on the inner packaging, located with the other label elements. It is not necessary to include the UFI on each layer of packaging, which is in derogation from Article 33 of CLP. If it is impossible to include the UFI on the inner packaging due to its shape or size, the UFI can be printed or affixed on the outer packaging, located with the other label elements. Additionally, the UFI shall be preceded by “UFI” followed by a colon (“UFI:”).
- In addition to the details of the submitter, the name, full address, telephone number and email address shall be provided for the point of contact (if different than the submitter) to be used for obtaining further information relevant to emergency health response purposes.
- For a mixture in mixture (MIM) component, if the full composition is not available, it can be identified in the submission by means of its product identifier along with its concentration and UFI, if available. The amendment has clarified that this is only allowable if the relevant appointed body has already received the information on the MIM.
- The generic product identifier “fragrances” has been omitted from the regulation; the generic product identifiers “perfumes” and “colouring agents” remain, and may be used for mixture components used exclusively to add perfume or colour, if certain conditions are met.
- There has been clarification on how the information on the pH of the mixture shall be provided. The pH shall be of the mixture as supplied or, where the mixture is a solid, the pH of an aqueous liquid or solution at a given concentration. The concentration shall be stated, and if the pH is not available, the reasons shall be given.
Should I be notifying mixtures in accordance with Annex VIII requirements now?
According to the latest available information, currently only two of the EU Member States, Estonia and Germany, are connected to the ECHA submission system and ready to accept notifications from duty holders. For all other Member States, duty holders must continue to notify their mixtures according to the requirements of national legislation until further notice (this will be at the latest until 31st December 2020 for mixtures placed on the market for consumer and professional use).
The transition period remains unchanged, and therefore if you have placed a product on the market and have notified Member States in accordance with current national legislation, then you will have until 1st January 2025 to comply with Annex VIII requirements – unless the product changes.
Other Poison Centre Resources:
- Poison Centre Notification Checklist
- Poison Centres: A “How To” Guide For Annex VIII Compliance [White Paper]
- Poison Centres: The First CLP Annex VIII Compliance Date for Mixtures for Consumer Use Agreed to be Postponed
Poison Centres: What You Need To Know
For more information about Poison Centres, check out our dedicated Poison Centres Homepage, where you can find the latest resources, including White Papers, Webinars and FAQs to help you understand your obligations under Annex VIII. You can also learn more about our expert tools and services which can help you meet your compliance requirements.
Need more assistance? Click on the button below, and complete the form to speak with one of our Regulatory Experts.
Commission Delegated Regulation (EU) 2020/11: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2020.006.01.0008.01.ENG&toc=OJ:L:2020:006:TOC
Commission Regulation (EU) 2017/542: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0542&rid=1
Recommended action items
- Review text of amendment
- Notify per requirements
CLP, Poison Centre, Annex VIII, UFI
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