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Nutraceutical Regulations and Registration in European Union (EU-EMA)

  • At a CAGR of 4.91% over the projected period (2023-2028), the Europe Nutraceutical Market is anticipated to increase from USD 79.95 billion in 2023 to USD 101.60 billion by 2028.

  • The European market is being driven by the rising number of health-conscious customers and their need for goods with healthy ingredients.

In the EU, nutraceutical products comes within the broader scope of "food or dietary supplements" & their regulations and registration falls under purview of EMA


This article outlines the nutraceutical regulations and registration in European Union (EU-EMA)

Nutraceutical Regulations Registration EU EMA

REGULATORY FRAMEWORK


Regulation (EU) No 1169/2011 on the Provision of Food Information to Consumers:

  • This regulation establishes rules for providing information about food products to consumers, including health supplement products.

  • It requires food supplements to be labeled with specific information, such as the list of ingredients, recommended daily dose, directions for use, allergen information, and more.

Directive 2002/46/EC on Food Supplements:

  • This directive provides the framework for regulating the composition, labeling, and advertising of food supplements across the EU.

  • It lists the vitamins and minerals that can be used as ingredients in food supplements and sets out the maximum levels for these nutrients.

Health Claims Regulation (Regulation (EC) No 1924/2006):

  • This regulation establishes rules for making health claims on food products, including food supplements.

  • Health claims must be authorized by the European Food Safety Authority (EFSA) and must be based on scientific evidence.

The directive specifies the guidelines that are exclusively applicable to the use of vitamins and minerals in the production of dietary supplements. Other than vitamins and minerals, the use of other materials in the production of dietary supplements may be governed by national laws or be covered by other particular EU regulations.

Food supplements are defined as concentrated sources of nutrients (vitamins and minerals) or other substances with a nutritional or physiological effect, intended to supplement the normal diet.


Documents Required

Product Information:

  • Name of the product and brand name.

  • Product category (e.g., vitamins, minerals, herbal extracts).

  • Form of the product (e.g., tablets, capsules, liquid).

  • Intended use and target consumer group.

  • Recommended dosage and directions for use.

Ingredients and Composition:

  • A list of all ingredients present in the product, including vitamins, minerals, herbal extracts, and other active substances.

  • Quantities of each ingredient per recommended dose.

  • Specifications for the purity and quality of ingredients.

  • Information on the source of ingredients (e.g., plant-based, synthetic).

Safety Assessment:

  • Scientific data on the safety of each ingredient, including any potential risks associated with their use.

  • Information on the safety assessment process, which may include toxicological studies, exposure assessments, and potential interactions.

Quality Control and Manufacturing:

  • Documentation related to the quality control and manufacturing processes, including good manufacturing practices (GMP) certificates if applicable.

  • Details on the production site, facilities, equipment, and quality control procedures.

Labeling and Packaging:

  • Drafts of the product label and packaging, including all required information according to EU regulations (e.g., list of ingredients, recommended daily dose, directions for use, allergen information).

  • Proposed labeling claims, if any (e.g., health claims, nutrient content claims).

Scientific Substantiation for Claims:

  • If making health claims on the product, scientific evidence to support these claims. The claims must be authorized by the European Food Safety Authority (EFSA).

Notification or Authorization Documentation:

  • Depending on the member state, documentation related to the notification or authorization process, including forms, fees, and any additional requirements set by the national regulatory authority.

Notification or Authorization from Other EU Member States:

  • If the product is already legally marketed in another EU member state, documentation proving this authorization may be required for cross-border trade.

Regulatory Process

Ingredient Approval and Listing:

  • The ingredients that can be used in food supplements are listed in Annex II of the EU Directive on Food Supplements (Directive 2002/46/EC).

  • If an ingredient is not listed, a safety assessment and approval process must be followed. Manufacturers must submit an application for authorization of a new ingredient to the relevant national authority in an EU member state. This application includes scientific data on the safety and bioavailability of the ingredient.

  • The national authority reviews the application and may consult the European Food Safety Authority (EFSA) for a scientific opinion.

Formulation and Composition:

  • Manufacturers must ensure that the formulation and composition of their food supplements comply with the permitted ingredients and their maximum levels.

Safety Assessment:

  • Manufacturers are responsible for conducting a safety assessment of their food supplements, including assessing potential risks associated with the ingredients and their levels.

  • The safety assessment should take into account the intended use, potential exposure, and any special population groups (e.g., children, pregnant women) that may be more vulnerable.

Labeling and Packaging:

  • Food supplements must have accurate and clear labeling that includes information such as the list of ingredients, recommended daily dosage, directions for use, warnings, allergen information, and more.

  • Health claims made on the packaging must be authorized by the EFSA.

Notification or Authorization:

  • Depending on the EU member state, food supplement manufacturers may need to notify the national competent authority before placing their products on the market.

  • In some cases, especially if a new ingredient is used, a formal authorization process may be required. This involves submitting detailed information about the product's composition, safety, and intended use.

Cross-Border Trade:

  • Once a food supplement is legally marketed in one EU member state, it can generally be sold in other member states without needing to undergo a new authorization process.

References:


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