Last Updated on September 29, 2022 by Ithos Global Regulatory Team
To Avoid Major Delays and Expenses, Verify Formulations Before Sending to a Responsible Person
To avoid major delays and expenses, brands should verify formulations before sending to a Responsible Person (RP) in the EU and UK. At Ithos, we see too many companies scrambling after a Safety Assessor will not sign off on a formula, artwork or claims reviews. By making compliance part of the product development process, you can avoid expensive setbacks and keep new products and new market launches on track.
“We’ll deal with the EU when we’re ready to expand there.”
“Our RP handles our compliance checks in the UK.”
We hear these responses all the time. Unfortunately, once you turn over your formula to an RP, a negative report from the Safety Assessor means you’re either headed back to the drawing board, reworking labeling, or ditching expansion plans altogether. We’ve seen existing purchase orders go unfulfilled. And your expensive clinical studies, artwork and production are suddenly worthless.
An RP can also take issue with the clinical studies for claims support, failing your formulation if the study and protocol are not developed to ensure they support the claims correctly. When companies are forced to retest, reformulate, and resubmit data – it costs valuable time and money.
By running potential formulas through the Ithos Information Network, our web-based compliance solution, you’ll be alerted if an ingredient is not compliant, in any jurisdiction. That way, you can make changes early, before committing to marketing campaigns, manufacturing, and other costs.
Do you Know the Four Primary Steps Every RP Takes?
When you send a formula to an RP in the EU and UK, there are four key steps taken before your product is approved to go to market:
1. Evaluation of formulation and documentation to confirm compliance within the jurisdiction(s)
2. Creation of a Consumer Product Safety Report (CPSR), otherwise known as a safety assessment, performed by a certified toxicologist, called a Safety Assessor
3. Evaluation of all labeling and claims to ensure the label formatting is compliant and all claims are formally supported
4. Formal notification of the results, via the EU and/or UK portals
While every brand has a different product development process, the milestones are the same. You may not be thinking about moving into new markets yet – but the Ithos Information Network ensures that when the time comes, you’re ready.
Staying Off Retailer No-No Lists
In addition to meeting key market regulations, another reason to verify new product formulations through the Ithos Information Network is increasing scrutiny from retailers.
Whether banning substances, approving brands, or featuring products that meet additional requirements, retailers such as Ulta and Target are showcasing their social responsibility with “No-No Lists,” “Green Lists,” “Clean Lists,” “Black Lists,” and others that are shared with customers online and in stores.
Because the IIN is constantly updated, we screen ingredients and formulas against these evolving lists, ensuring your product is ready to sell anywhere – and won’t be called out on social media for certain ingredients. This is why many brands continue to use the IIN long after their formula is approved.
Ithos as your Advocate
In some cases, Ithos can intervene on a brand’s behalf, providing expert regulatory explanation or key data to potentially amend a Safety Assessor’s decision to ensure agreement and marketability of a product.
Some RPs are more stringent than others, and this type of advocacy is done by our in-house regulatory experts on a case-by-case basis. An RP may not have access to the most up to date information, or the issue may be open to interpretation, such as rulings, use of symbols or labeling requirements. Our team can talk directly to the RP about your specific brand or product type.
To see how the Ithos Information Network can help you launch compliant products and avoid expensive delays, contact us to schedule a demo.