The EU PCN: Navigating the Land of Confusion
After five years of talking, planning, negotiating and, yes worrying, Brexit is finally here. Oh, and if that didn’t bring enough confusion to the European market on its own, the first deadlines for the European Union’s Poison Centre Notification (PCN) requirements are here, too.
If companies want to stay in compliance, there’s a lot of work to be done.
For years, the very idea of just getting ready for the EU PCN hung over industry like a shadow in a spotlight. As of Jan. 1, 2021, it officially became time to move from planning to implementing for mixtures intended for consumer and professional use; mixtures for industrial use will follow suit in 2024. This coincided with Great Britain’s exit from the European Union as the long delayed and debated Brexit finally took place. Not even two months into 2021, these two events have caused a plethora of significant changes and confusion for the regulatory landscape.
It’s important to note that while Northern Ireland is part of the United Kingdom, it is not part of Great Britain and therefore companies based in Northern Ireland will be obligated to comply with Annex VIII regulations.
With their official exit from the European Union, Great Britain has had to make decisions on how to handle regulatory standards. Most notably, Great Britain will not move forward with Annex VIII to the Classification, Labelling and Packaging (CLP) Regulation, which calls for the harmonization of the information to be submitted on hazardous materials including Unique Formula Identifiers (UFI). However, in Great Britain, Safety Data Sheets (SDS) can be submitted on a voluntary basis to the National Poison Information Service’s (NPIS’) Birmingham Unit.
The NPIS will be collecting the information for Northern Ireland, but because the NPIS will not have access to the European Chemicals Agency (ECHA) portal, all PCN dossiers must be created using the ECHA International Uniform Chemical Information Database tool, commonly referred to as IUCLID. If it is created through third-party tool, it must be imported into the ECHA IUCLID tool and then exported in the IUCLID format (.i6z) and sent directly to NPIS Birmingham as the appointed body by email.
- The pH Validation Rule: It’s a tale as old as time: a regulatory body unexpectedly pushes through a mandatory validation rule and chaos reigns as companies scramble to comply, the regulatory body realizes the error of its ways and rolls back the change.This is exactly what happened in October 2020 when ECHA released a major update to its XML format Version 3.0 and simultaneously pushed a new set of validation rules that required a mandatory justification for pH absence. To help our customers meet this rule, Sphera was able to deploy a quick update to accommodate this change. ECHA ultimately decided to temporarily rollback this validation rule.
- Packaged or Not? The first time we saw a request to support both packaged and not packaged items was in the LinkedIn ECHA PCN group. The customer asked about the possibility and ECHA helpdesk provided a workaround and announced changes to the IUCLID format to support both options by April 2021. To help companies address both options, Sphera released an update in January 2021. Additionally, two packaging types were included, cartridge and ampoule (a sealed vial), which were made available in the PCN format 3.0.
- Annex VIII’s Second Amendment: The second amendment to Annex VIII was published in November 2020. This amendment, often referred to as the workability amendment, will address issues identified by industries related to variations in mixtures. First, some variation in mixture can arise because of changes in components without affecting the classification, hazard or emergency health response. Additionally, different raw materials may be combined in a continuous production process, leading to ambiguity around the exact composition at any given time. This can lead to concentrations beyond the allowable range. Four sectors—cement, gypsum, concrete and petroleum—have proposed standard formulas. Finally, mixtures formulated on demand at the point of sale often have variations.
- Managing Change: While the EU PCN rollout has been phased in to help avoid confusion, it is inevitable when change is constant. That’s why Management of Change becomes imperative. Once the initial substance submission is complete, the work is not done; companies must monitor changes to the mixtures they have submitted. However, not all changes have a mandatory submission update. Managing these updates without automation can be cumbersome, if not impossible, especially for companies with large product portfolios.
What’s Next for ECHA?
ECHA announced that it plans to release an update to Annex VIII guidelines in March 2021. It is also planning an IUCLID service release for April 2021 with a major IUCLID release expected in October that will most likely include PCN format and validation rule updates. We also expect more updates from ECHA regarding Annex VIII guideline revisions, PCN format changes and System to System updates this year.
It’s a lot to process, for sure. And if Brexit weren’t complicated enough, the EU PCN can truly be the land of confusion when it comes to Chemical Management in the European Union without having the proper software solutions in place.