EU Regulatory Compliance for Importing Herbal Ingredients from India: A Buyer's Guide

Q: Does EU Novel Food Regulation apply to standard Ayurvedic herbs like ashwagandha and turmeric?

The key test under Regulation (EU) 2015/2283 is whether the food or ingredient was consumed to a significant degree within the EU before 15 May 1997. Turmeric rhizome, moringa leaf, tulsi, and most classic Ayurvedic herbs traded in conventional food and spice forms were present in European commerce before 1997 and are generally not subject to the Novel Food authorization requirement in those standard forms. However, novel extract types, high-potency concentrates, and standardised isolates - particularly those at specifications not previously available in the EU market - may be assessed as novel foods. Ashwagandha root extract has been the subject of Novel Food consultations in certain EU member states. The prudent approach is to verify your specific ingredient and form against the EU Novel Food Catalogue before placing orders, and to ask your Indian supplier for documented evidence of EU pre-1997 market presence if the Novel Food status is ambiguous.

Q: What are the most common reasons Indian herbal ingredient shipments are rejected at EU borders?

Based on EU Rapid Alert System for Food and Feed (RASFF) data and official EU import control records, the most frequent causes of rejection for herbs and spices from India are pesticide residue levels exceeding EU MRLs under Regulation (EC) No 396/2005, particularly for cumin from India (under a 30% inspection frequency since 2023) and cardamom, nutmeg, and mace from India (at 30% since July 2024), followed by mycotoxin contamination and microbiological non-compliance. Requiring a comprehensive lot-specific Certificate of Analysis from your Indian supplier before each shipment is the most direct way to catch compliance gaps before goods reach the EU border.

Q: Can I make health claims on EU products that contain Indian Ayurvedic ingredients?

Under Regulation (EC) No 1924/2006, health claims on food products must be scientifically assessed by EFSA and authorized by the European Commission. In 2010, the Commission suspended EFSA's assessment of approximately 1,500 health claims for botanical substances, and that suspension has remained in place. On 30 April 2025, the Court of Justice of the EU (Case C-386/23, Novel Nutriology) confirmed that this suspension does not create a transitional permission to use unauthorized claims. Claims such as supports stress resilience or promotes immune function for ashwagandha or tulsi in food supplement labeling and advertising are prohibited. Consult a food law specialist to review your labeling before launch in the EU.

Q: What pesticide testing should I require from my Indian herbal ingredient supplier for EU compliance?

For EU-bound supply, require a batch-specific multi-residue pesticide screening covering substances regulated under Regulation (EC) No 396/2005, run by LC-MS/MS and GC-MS/MS at detection limits of 3 to 10 parts per billion. The EU default MRL where no specific limit has been set is 0.01 mg/kg - one of the strictest default thresholds in the world. For dried herbal products, Article 20 of Regulation (EC) No 396/2005 allows the concentration caused by drying to be factored into MRL calculations using dehydration factors published by the European Spice Association. Given that cumin from India has been subject to elevated EU inspection frequencies due to pesticide residue violations, treat pesticide screening as a mandatory per-lot requirement rather than a periodic audit for any flagged Indian herb category.

The European Union is the world’s largest trading bloc for food and dietary supplement ingredients and one of the most significant destination markets for Indian herbal and botanical exports. EU-based supplement brands, functional food manufacturers, contract formulators, and ingredient distributors collectively source substantial volumes of Ayurvedic actives, botanical extracts, and herbal powders from India each year.

For EU buyers, the regulatory environment governing these imports is more complex than most markets outside of Japan. It operates across multiple intersecting frameworks - Novel Food authorization, pesticide maximum residue levels, contaminant limits, and health claims restrictions - each of which creates distinct compliance obligations. Understanding how these frameworks apply to Indian herbal ingredients, and knowing what to require from your Indian suppliers, is essential before committing to supply agreements.

This guide covers the EU regulatory requirements that directly affect international buyers sourcing herbal ingredients from India: the Novel Food Regulation, pesticide MRL framework, contaminant limits, health claims restrictions, and the documentation standard EU-compliant Indian suppliers should meet.

The EU Novel Food Regulation: The First Question to Answer

Before anything else, EU buyers importing an Indian herbal ingredient must determine whether that ingredient is a “Novel Food” under Regulation (EU) 2015/2283.

The regulation defines a Novel Food as any food that was not consumed to a significant degree within the EU before 15 May 1997. This date - carried forward from the original Novel Food Regulation (EC) 258/97 - is the threshold that determines whether an ingredient can be placed on the EU market freely or requires formal authorization through a process that typically takes one to three and a half years and significant scientific evidence.

For most standard Ayurvedic ingredients, the Novel Food question resolves relatively clearly. Turmeric rhizome and its conventional spice forms, moringa leaf and powder in standard dried formats, tulsi leaf, and most classic Ayurvedic herbs that have been traded in European food and supplement markets since before 1997 are generally not subject to the Novel Food requirement in those forms. The EU Novel Food Catalogue, maintained by the European Commission, lists the assessment status of many plant-origin products and is the first reference point for any Novel Food status query.

Where the Novel Food question becomes live: Novel Food issues arise with highly concentrated or standardised extracts, isolation of specific phytocompounds not previously in the EU food supply, and ingredients processed using methods not used before 1997. Some Indian botanical extracts - including certain ashwagandha root extract preparations - have been the subject of Novel Food status consultations in EU member states. If your ingredient or its specification raises a question, the prudent step is to consult the Novel Food Catalogue and, if ambiguous, submit a consultation request to the competent authority in the first EU member state where you intend to place the product on the market under Article 4 of Regulation (EU) 2015/2283. The consultation process is free and provides a formal determination.

The Traditional Food from Third Countries pathway: For ingredients that are novel in the EU but have a documented history of safe use in India, Regulation (EU) 2015/2283 provides a separate notification pathway for Traditional Foods from Third Countries. A food qualifies if it has a history of safe consumption for at least 25 years in a third country as part of the customary diet of a significant population. This pathway is faster and less burdensome than the full Novel Food authorization, and several Indian botanical ingredients have been successfully placed on the EU market via this route. Makhana (fox nut, Euryale ferox) was authorized as a traditional food from a third country in 2023 under this pathway.

Pesticide Maximum Residue Levels: The Most Frequent Point of Non-Compliance

Regulation (EC) No 396/2005 sets harmonized maximum residue levels (MRLs) for pesticides in food and feed sold in the EU. The same MRLs apply to all products on the EU market whether produced within the EU or imported - there is no separate import tolerance that eases requirements for non-EU suppliers.

The default MRL: Where no specific MRL has been established for a pesticide-commodity combination, the EU default applies: 0.01 mg/kg. This default is extremely strict - effectively the limit of analytical detection - and applies across virtually all plant-origin foods unless a higher specific limit has been set. For Indian herbal ingredient suppliers using crop protection practices common in Indian agriculture, this default can be the decisive compliance boundary.

Elevated inspection frequencies for Indian herbs: The EU maintains a list of products subject to temporary increases in official border checks where compliance concerns have been identified. As of 2024-2025, several Indian botanical products are subject to elevated inspection frequencies under Regulation (EU) 2019/1793. Cumin from India has been under a 30% inspection frequency since 2023 due to recurring pesticide residue violations, with the inspection rate maintained or increased into 2025. Nutmeg, mace, and cardamom from India were moved to a 30% inspection frequency in July 2024. When a product from a specific origin country reaches a high rate of non-compliance, the frequency of checks increases further - reaching 50% or higher for the most non-compliant product-country combinations.

What this means for EU buyers: Elevated inspection frequency does not mean your shipments will be detained, but it does mean they are substantially more likely to be physically checked. A non-compliant pesticide result at the EU border triggers a RASFF notification, which is publicly visible, and may result in a formal import restriction if non-compliance rates rise further. The practical protection is requiring a comprehensive, multi-residue pesticide screening from your Indian supplier - run at detection limits of 3 to 10 parts per billion by LC-MS/MS and GC-MS/MS - before each shipment departs India.

Dehydration factors for dried herbs: Article 20 of Regulation (EC) No 396/2005 allows for concentration caused by drying to be factored into MRL calculations. The European Spice Association has published dehydration factors for common herbs and spices. For dried products, the fresh product MRL is multiplied by the relevant dehydration factor to determine the applicable MRL for the dried form. Your Indian supplier or your EU customs or regulatory advisor can apply these factors when interpreting COA pesticide results against EU limits.

Contaminant Limits: Heavy Metals and Mycotoxins

Regulation (EU) 2023/915 sets maximum levels for contaminants including heavy metals in food. For herbal ingredient buyers, the relevant contaminants are:

Lead - maximum levels range from 0.1 mg/kg for many plant-based foods to higher limits for specific food supplement categories. Lead contamination in herbal ingredients primarily reflects soil conditions and agricultural inputs at the origin of cultivation.

Cadmium - maximum levels for plant-based ingredients vary by product category. Root crops and ingredients from cadmium-accumulating plant species require particular attention.

Mercury and arsenic - specific limits apply to certain food categories. Arsenic limits for food are currently being reviewed and tightened by the European Commission following EFSA assessments.

Nickel - new maximum levels for nickel in a range of foods took effect in July 2025 under Regulation (EU) 2023/915. This is one of the most recent additions to EU contaminant regulation and Indian herbal ingredient buyers should verify their supplier’s COA testing covers nickel alongside the established heavy metals.

Aflatoxins - maximum levels for aflatoxins in spices and dried herbs are set under Regulation (EU) 2023/915. Aflatoxins are produced by Aspergillus moulds in conditions of high humidity and inadequate post-harvest storage. Indian herb exports have historically been flagged in RASFF for aflatoxin exceedances in certain product categories. Require aflatoxin testing covering B1, B2, G1, and G2 as standard for any dried herb or botanical powder supplied from India.

Ochratoxin A - relevant for dried herbs including those in the ginger family and other rhizome-derived ingredients.

For EU-bound supply, the minimum expectation is that your Indian supplier’s lot-specific COA covers all contaminants for which EU maximum levels are set in the relevant product category under Regulation (EU) 2023/915.

Health Claims: The Most Consequential Restriction for EU Buyers

This is the area where EU regulation most directly constrains the commercial use of Indian herbal ingredients in finished products - and where the regulatory situation changed materially in 2025.

Under Regulation (EC) No 1924/2006 on Nutrition and Health Claims, any health claim on food sold in the EU must be scientifically assessed by EFSA and formally authorized by the European Commission before it may be used on labels or in marketing. Authorized claims are listed in Regulation (EU) No 432/2012.

The botanical health claims suspension: In 2010, the European Commission suspended EFSA’s assessment of approximately 1,500 pending health claims for botanical substances, citing complexity and resource constraints. This suspension has remained in place for more than 15 years. During this period, many EU supplement brands and distributors operated on the assumption that claims on botanical products were in a permitted transitional state - neither authorized nor formally prohibited.

The April 2025 CJEU ruling (Case C-386/23, Novel Nutriology): On 30 April 2025, the Court of Justice of the EU issued a landmark judgment that resolved this ambiguity definitively and unfavorably for botanical health claims. The Court ruled that Article 10(1) of Regulation (EC) No 1924/2006 contains a fundamental prohibition on health claims that are not authorized and included in the approved list. The prolonged suspension of EFSA’s assessment process does not create a transitional permission to use those claims. Unless an application for authorization was submitted to the European Commission by 19 January 2008 and the transitional procedural requirements were met, unauthorized health claims for botanical substances in commercial advertising are prohibited.

What this means for EU buyers of Indian herbal ingredients: Claims such as “supports stress resilience,” “promotes relaxation,” “supports immune function,” “promotes cognitive performance,” or “supports joint comfort” - standard language across ashwagandha, tulsi, brahmi, boswellia, and turmeric supplement products - cannot currently be used in EU product labeling or marketing. Nutrient function claims for vitamins and minerals listed in Regulation (EU) No 432/2012 remain authorized and are unaffected. The restriction applies to botanical substance claims regardless of the strength or volume of traditional use evidence behind them.

The practical implication for purchasing decisions: EU buyers should not assume they can replicate US-market or UK-market label claims on EU-sold products containing Indian botanical ingredients. Review your product labels and marketing materials against the EU authorized claims list before launch, and consult a food law specialist if your product relies on botanical health claims that have not been formally authorized.

Organic Claims: EU Certification Requirements

If you are sourcing organic Indian herbal ingredients for EU-market products carrying an organic claim, the certification requirement is specific.

The EU organic regulation (EU 2018/848) requires that organic products placed on the EU market - whether produced in the EU or imported - are certified under EU organic rules or under a recognized equivalence arrangement. Certification must be issued by a control body approved by the European Commission.

Indian NPOP organic certification is recognized by the EU under an equivalence arrangement, but this equivalence applies only when the Indian NPOP-certified product is certified by a control body that is also approved by the EU for the equivalence arrangement. Not all NPOP-certifying bodies in India hold EU equivalence recognition. Before accepting Indian NPOP organic certificates as evidence of EU organic equivalence, verify that the certifying body is listed on the EU’s official list of recognized control bodies for organic imports from India.

For EU buyers, the safest approach is to require that your Indian supplier holds dual certification - Indian NPOP certification from an equivalence-recognized body, or direct EU organic certification from an EU-approved control body operating in India. Several EU-approved certification bodies including Control Union, ECOCERT, and SGS operate certification programs for Indian organic producers.

What to Require from Your Indian Supplier for EU Market Compliance

Consolidating the requirements above, EU-bound Indian herbal ingredient sourcing should be supported by the following documentation as standard:

Novel Food and regulatory status:

Written confirmation of the ingredient’s Novel Food status, referencing the EU Novel Food Catalogue or a formal consultation outcome from an EU member state competent authority, where status is not clearly established

GMP and quality systems:

GMP certification under WHO-GMP, EU-GMP, or an equivalent standard recognized in the EU food supplement market; or a valid Schedule T certificate as a baseline domestic standard with supporting third-party audit
FSSAI Central License as the Indian food safety baseline

Per-shipment documentation:

Batch-specific Certificate of Analysis from a NABL-accredited laboratory covering: botanical identity (HPLC or TLC), active constituent assay at declared specification, moisture content, heavy metals (lead, cadmium, mercury, arsenic, nickel) tested against Regulation (EU) 2023/915 limits by ICP-MS, pesticide multi-residue screening by LC-MS/MS and GC-MS/MS at limits of quantification of 10 ppb or lower, mycotoxin screening (aflatoxins B1/B2/G1/G2, ochratoxin A), microbial limits (total aerobic count, yeast and mould, absence of Salmonella spp. and E. coli)
Phytosanitary certificate issued by NPPO India prior to shipment
Certificate of Origin
Health Certificate or Free Sale Certificate from APEDA or relevant Indian authority where required by the importing EU member state

For organic supply:

EU organic certificate from an EU-approved control body, or NPOP certificate from a body with confirmed EU equivalence recognition - verify the certifying body’s status on the European Commission’s approved list before accepting the certificate

EU Import Controls and the RASFF Database

The EU operates a rapid alert system for food safety - RASFF (Rapid Alert System for Food and Feed) - which logs and publicly reports all food safety notifications including border rejections. RASFF data is publicly searchable and provides a real-time picture of compliance issues by product category and country of origin.

Before committing to a new Indian herbal ingredient supplier for EU-bound supply, search the RASFF database for notifications involving the relevant ingredient and India as the country of origin. A cluster of recent RASFF notifications for a specific product type signals elevated compliance risk in that category and should inform your supplier qualification process and COA requirements.

EU official controls on food imports are coordinated through Regulation (EU) 2017/625. Member state competent authorities are responsible for border inspection at ports of entry, and the European Commission publishes an updated list of products subject to enhanced import controls. Monitoring this list for product categories relevant to your sourcing is part of responsible EU compliance management.

The EU Market and India: Getting Compliance Right from the Start

The EU presents the most technically demanding regulatory environment for international buyers of Indian herbal ingredients. The combination of strict pesticide MRLs, comprehensive contaminant limits, a Novel Food authorization process that affects certain extract types, and the April 2025 CJEU ruling on botanical health claims creates a compliance landscape that rewards thorough pre-import due diligence.

Indian herbal ingredient suppliers who serve the EU market successfully have invested in analytical capacity - holding NABL-accredited laboratories capable of running multi-residue pesticide panels, heavy metal ICP-MS testing, and mycotoxin analysis at EU-compliant limits. They maintain current GMP certification, understand the Novel Food status of their ingredient portfolio, and can provide per-lot COA documentation that maps directly to EU regulatory limits rather than to generic in-house specifications.

The gap between these suppliers and those producing to Indian domestic standards is material. Getting this right at the supplier selection stage - before goods are at the EU border - is substantially less costly than managing a RASFF notification, a border rejection, or a product withdrawal after EU distribution has begun.

Sourcing herbal ingredients from India for the EU market? Ayris Global works with verified Indian producers who maintain EU-compliant quality systems and can provide the testing and documentation EU buyers require. Contact our sourcing team to discuss your ingredient requirements, or visit our For Buyers page for more information.

Frequently Asked Questions

Does EU Novel Food Regulation apply to standard Ayurvedic herbs like ashwagandha and turmeric?

The test under Regulation (EU) 2015/2283 is whether the ingredient was consumed to a significant degree within the EU before 15 May 1997. Turmeric in spice form, moringa leaf powder, tulsi, and most classic Ayurvedic herbs traded in conventional food and supplement forms before 1997 are generally not subject to the Novel Food authorization requirement in those standard forms. However, novel extract types, high-potency concentrates, and standardised isolates may be assessed as novel foods. Verify your specific ingredient and form against the EU Novel Food Catalogue before placing orders.

What are the most common reasons Indian herbal ingredient shipments are rejected at EU borders?

Based on RASFF data, the most frequent causes are pesticide residue levels exceeding EU MRLs - particularly for cumin from India, which is under a 30% inspection frequency, and for cardamom, nutmeg, and mace from India at 30% since July 2024 - followed by mycotoxin contamination and microbiological non-compliance. Requiring a comprehensive lot-specific COA from your Indian supplier before each shipment is the most direct way to identify compliance gaps before goods reach the EU border.

Can I make health claims on EU products that contain Indian Ayurvedic ingredients?

No - not for botanical health claims that have not been formally authorized under Regulation (EC) No 1924/2006. The April 2025 CJEU ruling (Case C-386/23, Novel Nutriology) confirmed that the prolonged suspension of EFSA’s botanical health claims assessment does not create a transitional permission to use those claims. Claims such as “supports stress resilience” or “promotes immune function” for ashwagandha or tulsi are prohibited in EU labeling and advertising unless specifically authorized. Consult a food law specialist before launching EU products containing Ayurvedic botanical ingredients.

What pesticide testing should I require from my Indian herbal ingredient supplier for EU compliance?

Require a batch-specific multi-residue pesticide screening covering substances regulated under Regulation (EC) No 396/2005, run by LC-MS/MS and GC-MS/MS at detection limits of 3 to 10 parts per billion. The EU default MRL where no specific level is set is 0.01 mg/kg - effectively the detection limit. For dried herbal products, dehydration factors published by the European Spice Association can be applied to adjust MRL compliance calculations.

What documentation should I require from an Indian herbal ingredient supplier to import into the EU?

At minimum: batch-specific COA from a NABL-accredited laboratory covering botanical identity, active constituent assay, ICP-MS heavy metals (including nickel, which has limits effective from July 2025), pesticide multi-residue screening, mycotoxin testing, and microbial limits; phytosanitary certificate from NPPO India; Certificate of Origin; and where relevant, a Free Sale or Health Certificate. For organic claims, require an EU organic certificate or NPOP certification from a control body with confirmed EU equivalence recognition. Also confirm the ingredient’s Novel Food status before import.

Ayris Global connects international buyers with verified Indian producers of botanical extracts, Ayurvedic actives, herbal powders, and nutraceutical ingredients. To discuss EU-market sourcing requirements, contact us at sourcing@ayrisglobal.in or visit our For Buyers page.