It is official – the deadline for the poison centres consumer-use mixtures has been extended
Commission Delegated Regulation (EU) 2020/11 of 29 October 2019 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 information relating to emergency health response was published last week.
Regulation (EU 2020/11) amends Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP), specifically Annex VIII, by clarifying the position relating to emergency health response – otherwise known as poison centres. The amendment extends the first deadline to 1 January 2021 for consumer use mixtures. The deadlines for professional-use and industrial-use mixtures remain as 1 January 2021 and 2024 respectively. The Regulation also clarifies that the unique formula identifier (UFI) may now be included on the product packaging or labelling.
This delay of a year is significant and helps the European Chemicals Agency (ECHA) and the industry. It gives the ECHA more time to get the tools in place and resolve the workability issues, and enables industry to take advantage of the extra year by making notifications now under the current Member State rules. Businesses that make their notifications under the Member State rules can benefit from the transitional period until 1 January 2025, when they must make their notifications under the new Annex VIII harmonised rules.
The need to notify hazardous mixtures within European Member States is a mandatory requirement already in place. Waiting until the format is harmonised leaves companies non-compliant and open to penalties. However, notifying now under Member States rules has many benefits such as:
- Early compliance with current regulations – poison centre notification is a legal requirement and is mandatory now across Member States. Early compliance provides peace of mind in an ever-changing regulatory landscape.
- Potential cost benefits – enforcement is increasing across Member States and non-compliance could be very costly. In addition, as the deadline gets closer, there is increased workload for poison centres and fee increases may be used to help secure the extra resources needed.
- Extended time to comply – UFI numbers would not be required until 2025, allowing those companies notifying now a grace period to create them and update labels/packaging in a timely manner. Additionally, if you use other suppliers' mixtures in your own formulation then, from 2021, you will need to include their UFI in your submission. Therefore, if suppliers make any changes to their products that would require an update to their notifications (such as a change in composition or classification) and they will need to generate a new UFI which could trigger an update to your own notifications. Notifying now would mean that there would be no need to make these updates until 2025.
- Greater confidentiality – many Member States currently allow reduced notifications, so there is no requirement to disclose the full composition. With the extension to 2025, this effectively 'buys' up to 5 years before the full composition must be disclosed (assuming no change is made to the declared information that would require an update) as Annex VIII will introduce narrower ranges when declaring product composition.
Submitting notifications for some companies is going to be a substantial task, but any notifications that are completed before the Annex VIII deadlines are valid until 2025, assuming there is no change in classification. Businesses can take advantage of a grace period of 5 years to monitor these regulations and see how the changes are going to affect their company. Just recently, a large company changed its approach; the plan had been to wait and notify under Annex VIII, but the business decision has just been made to notify now under current Member State rules to protect the company's formulation.
The amendment to Annex VIII can be found here.
We believe that the best advice we can give to our customers is to notify now and benefit from the extended deadline of 2025.
If you think that your business may be well positioned to take advantage of this extension to the deadline, but would like further advice, please don’t hesitate to get in touch.
Based on Official Journal L6 of the European Union, 1998-2020, Document 32020R0011