Demystifying Botanical Ingredients: An In-Depth Outlook in Europe

The webinar was successfully concluded on

May 7, 2025

Thank you for joining our Freyr Webinar Series on “Demystifying Botanical Ingredients: An In-Depth Outlook in Europe” on May 07, 2025!

Key Takeaways:

We explored the Regulatory landscape for botanical ingredients in Europe.
Discussed challenges in placing botanical products on the market.
Highlighted FBO responsibilities and real-world examples of popular botanicals.

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Thank you again for attending! Stay tuned for future sessions in the Freyr Webinar Series.

Meher Bhattiprolu, as the Manager of Global Regulatory Services for Food Products at Freyr Solutions, boasts a decade of expertise in Regulatory and quality assurance across diverse industries including food, nutraceuticals, pharmaceuticals, cosmetics, and personal care. With a background as a Pharmacist, Meher possesses core competencies in Regulatory strategy and solutions, global project support, quality assurance, compliance, new product development, and product registrations across multiple markets.

Giulio Libertini is a Regulatory Specialist and biologist with a solid background in public health and food safety. In 2010, he started working as a Regulatory professional, gaining valuable experience with Health Authorities (HAs) and Regulatory bodies. He has four (04) years of experience in food compliance and labeling of food supplements, fortified foods, and foods for specific groups, with successful projects in several different countries. His primary expertise is food compliance evaluation along with food labeling, Regulatory submissions, and nutritional/health claims.

Aspect	USA	EU	Australia	China	UAE
Regulatory Authority	FDA	EFSA & Member State Authorities	FSANZ	SAMR & NHC	ESMA & MOHAP
Major Regulation Governing Compliance	Federal Food, Drug, and Cosmetic Act (FFDCA); 21 CFR Part 110 (Current Good Manufacturing Practices)	Regulation (EC) No 178/2002 (General Food Law); Regulation (EU) No 1169/2011 on Food Information to Consumers	Food Standards Code (Australia New Zealand Food Standards Code)	Food Safety Law of the People's Republic of China (Revised 2015); GB Standards for Food Safety	UAE.S GSO 9:2017 (GCC General Requirements for Prepackaged Food)
Pre-market Approval Required?	No pre-market approval except for novel ingredients, color additives, or specific claims	No pre-market approval for general foods, but novel foods or health claims require EFSA approval.	No pre-market approval unless it's a novel food or makes health claims	Pre-market registration is required for novel foods, health foods, or products with new ingredients	Pre-market approval is required for certain foods, health products, and products with new ingredients
Processed Food Labeling Compliance /Labeling Requirements	Mandatory labeling as per FDA guidelines (Nutrition Facts, Ingredient Declaration, Allergens)	Must comply with EU Food Information Regulation (1169/2011); includes allergens, nutrition, and origin labeling.	Must follow FSANZ Food Standards Code for labeling; nutrition panels, allergens, and ingredient lists required	Must follow GB 7718-2011 (National Food Safety Standards) for labeling; mandatory nutrition facts, allergens, and shelf-life	Must follow GSO 9:2017 for pre-packaged food labeling; Arabic labeling, allergens, and nutrition facts required
Timeline for Registration	No fixed timeline: products can enter the market once compliant	No formal registration unless novel food; EFSA approval for health claims takes 12-18 months	No formal registration unless it's a novel food or makes health claims	Typically, 12-24 months for novel foods, shorter for regular processed foods	Approval may take 6-12 months for certain products. Regular processed foods can enter the market once label approval is obtained

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Demystifying Botanical Ingredients: An In-Depth Outlook in Europe

Demystifying Botanical Ingredients: An In-Depth Outlook in Europe

Key Takeaways:

Host

Meher Bhattiprolu

Presenter

Giulio Libertini

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