Month: August 2018

The European Food Safety Authority (EFSA) is a world renowned regulator which is known for its high scientific standards when it comes to food safety and claim substantiation. Formed in 2002 following several mishaps involving food safety, EFSA is responsible for the evaluation of scientific evidence and identification & communication of risks pertaining to safe practices in the areas of food & nutrition, animal feeds, animal health, plant protection and plant health.

Why are EFSA’s methods and findings important?

EFSA uses high level scientific evaluation to formulate their opinions. While some may argue their findings are only applicable to the European market, this is not entirely true. EFSA’s regulatory opinion is valued in many other jurisdictions. For example, in December of 2015 the Canadian Food Inspection Agency (CFIA), Canada’s science-based regulator of food, animals and plants, officially agreed to collaborate with EFSA for the collection, analysis and sharing of data pertaining to risk assessments. Both regulatory bodies also agreed to share views and expertise on methods for data collection, risk assessment and risk communication. Further to this, EFSA’s assessments are also highly regarded by regulatory officials at Health Canada. If you have obtained EFSA approval for a food ingredient or a health claim, it is likely that your evidence will be approved by Health Canada as well.

While it is up to EFSA’s team of experts to formulate the final opinion, they seek comments from stakeholders prior to finalization of their reports. Of particular interest to our industry is their current consultation. They are currently seeking consultation for the Guidance on the Requirements for Health Claims Related to Physical Performance.  This draft guidance outlines EFSA’s current view on the evidence required to support claims on muscle function, physical performance and physical capacity. The consultation is open until September 2, 2018 and comments are welcome from any interested party, but please note comments will be made public.

If you are marketing a workout supplement in Canada, the United States or Europe, EFSA’s draft guidance document is worth a read. If the evidence you have on file aligns with the final published views of EFSA, it is likely your claims will be substantiated. This is beneficial for your Canadian products since it will help facilitate the approval of your innovative natural health products geared to support muscle function & physical performance.

EFSA’s opinions may also benefit your American dietary supplements. If the evidence you have on file to substantiate your clear and meaningful claims matches that required for European approval, then it is likely that you have competent and reliable scientific evidence to render your health claims truthful and not misleading.

If you are interested in bringing a workout supplement to Europe, Canada or the United States, or if you would like to submit anonymous comments to EFSA on their draft Guidance on the Requirements for Health Claims Related to Physical Performance, Quality Smart Solutions has a team of specialists who can assist you.  Contact us today to discuss how we can be your solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices, OTC drugs and Canna. Ask us for details or visit our website at www.qualitysmartsolutions.com.