As of Jan. 1, 2021 the new European Union Poison Centres Notification (EU PCN) rules officially went into effect for mixtures intended for consumer and professional use. A few months into this new regulatory era, Sphera has identified the top three lessons learned.
1. Flexibility, Flexibility, Flexibility
- The EU PCN, which has implications across the board, has been a moving target. Having the agility and flexibility to adapt as the target shifts, sometimes overnight, has been a key to successful compliance. Some examples where flexibility have been needed are:
- The requirement for justification of not having a pH was suddenly required by the submission format with the release of an International Uniform Chemical Information Database (IUCLID) update. Although this was not a new requirement, this was an instance where companies had to wait for the European Chemicals Agency (ECHA) to update their IT systems to be able to collect this data.
- The workability amendments changed how some businesses would need to comply with the rules about four months before the first compliance deadline.
- There are changes and frequent changes and you need to cope with that. Changing course or just having to sit tight are both hard to do, but sometimes waiting is the best course of action.
- While we don’t foresee any other changes to Annex VIII itself, we do know that both IUCLID and the validation rules that impose further requirements for the data submission are continuing to evolve.
2. Plan ahead
- Understanding the implications of your business decisions in relation to regulations is paramount.
- Know your product lines, know what is required to be sent, where the product is marketed, how it is packaged (or not packaged). Where workability amendments are concerned, evaluating the provisions for interchangeable component groups could be important for some products.
- Have processes in place for changes to existing products (selling to a new market, new package type, etc.).
- If Mixture in Mixture (MiM) is part of your formulations, know what data you need for your MiMs (unique formula identifier [UFI] and/or composition) and have processes in place to manage changes to MiMs
- All of this should be figured out before creating a dossier. Having the information before you begin that process will prevent frustration and save time in the long run.
3. Build a solid relationship
- Having a solid relationship with the team that is designing your software system is key. They need to understand your business and your goals in order to help you maximize efficiency. PCN is not a long or difficult regulation, but that does not minimize its importance since it is a requirement where regulations meet business processes. There are many business decisions where data needs to be collected and maintained in order to complete a successful submission. Is your software designer taking your business into consideration or are they creating a solution in a vacuum?
In our experience, companies create product data in all sorts of ways for different purposes outside of the PCN. The way this data was created and managed was not as anticipated. Furthermore, large amounts of legacy data can’t be easily modified. Sometimes there really is a good reason for why the customer data is the way it is. If it’s not accounted for in the software implementation, it could have large or drastic implications on the amount of effort required to prepare and submit dossiers or, worst case, even being able to submit one at all.