Happy Summer everyone! I hope you are all enjoying the wonderful summer weather and getting the opportunity to take some time off work for family vacations. In the U.S., we are only a week away from our Independence Holiday, and that means the local corn crops should be “knee-high.”
This month, I’d like to discuss handling updates to product compositions for purposes of regulatory requirements. While there are many published reports on why Management of Change (MOC) is important to controlling environmental, health, and safety risks prior to implementing significant changes, there is not a lot of reporting on how these changes impact regulatory requirements. When we speak about capturing compositions, we are referring to a complete composition of the product. This includes all raw materials and impurities, such that the components add up to 100%. We have previously mentioned in September’s blog, that full compositions are critical for evaluating your product against chemical inventories, chemical registrations, banned & restricted lists, and other regulatory requirements.
Do you have an MOC process for overseeing revisions to your compositions? What should you monitor to keep up with this?
Although there are many variables that can change a product’s composition, from a risk-based approach, the two most critical are being aware of new product introductions and any changes to raw materials.
For new product introductions, you need to be closely connected to your scientists or product development team that are announcing new products. Get them into the habit of speaking to you early in the process about new products. Not only can you capture the compositions for your files, but it gives you the opportunity to do a regulatory assessment. Your team will want to know in advance if there are going to be any issues with selling the product into any global regions.
For raw material changes, there are different ways to be connected into such modifications. This can sometimes be a bit challenging. Ultimately, you need to find the right one that works with your production environment. When you do learn of raw material changes, be sure to capture the new compositions for your files, but also review to see if the changes caused any regulatory impacts or other risks to the business. In addition, determine if you are required to notify your downstream customers for product composition changes.
Understanding your product compositions and staying abreast of changes will go a long way towards keeping you in regulatory compliance. You just need to have a good MOC process and evaluate any changes as they occur. If you need any help with setting up your MOC process, contact us at Strategic Realm Consulting, and we can assist you with that.