Grape Seed Extract

About

What it is and where it shows up.

Grape seed extract (GSE) is a polyphenol-rich botanical extract derived from the seeds of Vitis vinifera, primarily composed of oligomeric proanthocyanidins (OPCs), catechins, epicatechins, and gallic acid. It is used in food, dietary supplements, and functional beverages as a natural antioxidant, flavouring agent, and nutraceutical ingredient with purported cardiovascular and antimicrobial benefits.

Safety summary

The regulatory and scientific consensus.

GSE is generally considered safe at typical dietary and supplemental doses with no IARC carcinogenicity classification and no established numerical ADI from major regulatory bodies; EFSA has concluded it does not exhibit endocrine-disrupting, neurotoxic, or immunotoxic properties. High-dose supplementation may interact with anticoagulant medications and antihypertensive drugs (including ACE inhibitors, beta-blockers, calcium channel blockers, and diuretics), and patients on such therapies should seek medical advice before use. Safety data for supplemental use during pregnancy, lactation, and in infants and young children remain insufficient to establish a safe intake level.

Regulatory landscape

What food-safety regulators have decided.

Jurisdiction	Status	Note
Health Canada (Canada)	Approved	Grape seed extract is among the botanical ingredients permitted for use in supplemented foods under Health Canada's Temporary Marketing Authorization Letter (TMAL) system, subject to specific conditions including ingredient specification, addition limits, and labelling requirements.source
EFSA (European Food Safety Authority) (European Union)	Approved	Under Regulation (EC) No 1334/2008, flavouring preparations produced from food sources such as grape extracts do not require specific prior authorisation before being placed on the EU market for food use. Additionally approved as a basic substance for plant protection (fungicide) under Commission Implementing Regulation (EU) 2025/96, which entered into force approximately 20 days after its publication on 21 January 2025. No E-number has been assigned.source
FSSAI (Food Safety and Standards Authority of India) (India)	Approved	Grape seed extract is listed as a permitted ingredient (Schedule item 85) under the FSSAI Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food Regulations, 2016 (implementation advisory issued December 2017). Not permitted for use in products targeted at infants up to 24 months.source
FDA (Food and Drug Administration) (United States)	Approved	GSE is commercially marketed as a dietary supplement ingredient under DSHEA and recognised as a flavouring compound under FEMA GRAS 4045 (CoE 485). No standalone GRAS notice for GSE as a direct food additive has been issued by FDA. A separate GRAS notice (GRN 886) exists for monoacylglycerides derived from grape seed (Apeel Sciences), which is a chemically distinct ingredient.

Who should approach with care

Whose guidance would steer them away.

Pregnancy — Insufficient clinical safety data exist for high-dose grape seed extract supplementation during pregnancy; general caution is advised as effects on fetal development have not been adequately characterised in human studies.

Lactation — No adequate human safety data are available for supplemental GSE use during breastfeeding; transfer of concentrated polyphenolic compounds into breast milk has not been sufficiently studied.

Infants — FSSAI nutraceutical regulations explicitly exclude products for infants up to 24 months of age, and no regulatory body has established a safe supplemental dose of GSE for this age group.

Children — No established safe supplemental dose of grape seed extract has been set for children by any major regulatory authority; use in paediatric populations should be supervised by a healthcare provider.

Hypertension — EFSA NDA Panel (2021) specifically flagged potential interactions between grape seed extract and antihypertensive medications including ACE inhibitors, beta-blockers, calcium channel blockers, and diuretics, requiring case-by-case evaluation.

Research citations

The sources behind this verdict.

1EFSA. Overall conclusions on the application for approval of grape seed extract as a basic substance to be used in plant protection as a fungicide on grapevines, apples, potatoes and lettuce, 2023. efsa.europa.eu
2PubMed. A Systematic Quantitative Determination of the Antimicrobial Efficacy of Grape Seed Extract against Foodborne Bacterial Pathogens, 2023. pubmed.ncbi.nlm.nih.gov
3EFSA. MegaNatural®‐BP grape seed extract and maintenance of normal blood pressure: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006, 2021. efsa.europa.eu
4FSSAI. Implementation of Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016, 2018. fssai.gov.in
5EFSA. Dry grape extract for all animal species, 2016. efsa.europa.eu

Independently researched5 citations