Key takeaways
- Germany is the EU's largest market for herbal products, consuming over 25% of all herbal teas and dietary supplements sold in the bloc. If you can export medicinal herbs to Germany, the rest of the EU follows.
- The LFGB (Lebensmittel- und Futtermittelgesetzbuch) is Germany's central food and feed code. Every herbal ingredient sold in Germany must comply with LFGB requirements on safety, labelling, and traceability.
- BfR (Bundesinstitut fuer Risikobewertung) issues risk assessments and maximum level recommendations that German enforcement agencies apply. BfR opinions on pyrrolizidine alkaloids and heavy metals are stricter than baseline EU rules.
- Product classification determines your entire regulatory pathway. A chamomile batch classified as herbal tea faces different rules than the same chamomile classified as a traditional herbal medicine. Get classification wrong and you face import refusal.
- Documentation is the deal-breaker: Certificate of Analysis, phytosanitary certificate, EUR.1 origin certificate, TRACES notification, and German-language labelling must all be correct before your shipment arrives at Hamburg or Bremen.
Introduction
Germany is the gateway to European herbal commerce. With a population of 84 million consumers who spend more on natural health products per capita than any other EU member state, the German market represents the single highest-value destination for suppliers looking to export medicinal herbs to Germany and the broader EU. The country's deep-rooted Naturheilkunde (natural healing) tradition, combined with a sophisticated retail infrastructure spanning pharmacies, Reformhaeuser (health food stores), organic supermarkets, and online platforms, creates sustained demand for quality botanical ingredients.
But Germany is also one of the most heavily regulated food and supplement markets in the world. The regulatory framework involves multiple federal agencies, overlapping EU and national rules, and enforcement standards that frequently exceed EU minimums. Suppliers who approach Germany with documentation calibrated for less demanding markets routinely face border rejections, product seizures, and blacklisting by importers.
This guide walks B2B suppliers and procurement managers through every layer of Germany's regulatory landscape for medicinal herbs and botanical ingredients, from market fundamentals through classification, contaminant limits, labelling, and import documentation. If you are already familiar with the broader EU market entry process, this post drills into the Germany-specific requirements that sit on top of that EU baseline.
Germany's herbal product market
Market size and growth
Germany's herbal products market is valued at approximately EUR 12 billion annually when measured across herbal teas, dietary supplements, natural cosmetics, and traditional herbal medicinal products. The herbal tea segment alone accounts for roughly EUR 1.2 billion in annual retail sales, making Germany the largest herbal tea market in Europe by a significant margin. Growth has been consistent at 4 to 6 percent year-over-year since 2020, driven by consumer preference for preventive health, clean-label products, and plant-based alternatives.
The B2B ingredient supply chain feeding this market is dominated by importers based in Hamburg, Bremen, and Frankfurt, who source raw materials from Turkey, Egypt, India, Morocco, and Eastern Europe. Turkish suppliers hold structural advantages in key product categories including oregano, sage, thyme, linden blossom, chamomile, rosehip, and dried fig, benefiting from geographic proximity, the EU-Turkey Customs Union, and competitive pricing against North African and South Asian origins.
German consumer preferences and the Naturheilkunde tradition
Germany's consumer relationship with medicinal herbs is qualitatively different from most EU markets. Naturheilkunde (naturopathy) has been embedded in German healthcare culture since Sebastian Kneipp's nineteenth-century hydrotherapy movement. German health insurance funds (Krankenkassen) reimburse certain traditional herbal medicines. Pharmacies stock herbal preparations alongside pharmaceuticals, and pharmacists routinely recommend botanical products. This cultural infrastructure means German consumers are educated buyers who read labels, understand dosage forms, and demand third-party quality verification.
For B2B suppliers, this translates into procurement specifications that are frequently more demanding than the legal minimums. German importers will ask for full Certificates of Analysis, supplier audits, and documentation of the entire supply chain from field to warehouse. Reviewing our CoA guide before engaging a German buyer is strongly recommended.
Key product categories
| Category | Examples | Typical use | Market channel | |---|---|---|---| | Herbal teas | Chamomile, peppermint, linden, sage, rosehip | Wellness beverages, pharmacy teas | Retail, pharmacy, food service | | Dietary supplements | Valerian extract, artichoke leaf, milk thistle | Capsules, tablets, liquid extracts | Pharmacy, health food, online | | Natural cosmetics | Lavender oil, rose extract, calendula | Skincare, aromatherapy | Pharmacy, organic retail | | Traditional herbal medicines | St. John's wort, ginkgo, devil's claw | Registered medicinal products | Pharmacy only | | Herbal raw materials (B2B) | Dried whole herbs, cuts, powders, extracts | Ingredient supply for manufacturers | Wholesale, direct contract |
Arovela's medicinal herb range and essential oils cover the botanical inputs that feed all five categories above.
Regulatory framework
Germany's regulatory system for herbal products involves three principal federal agencies operating under a framework that combines EU regulations with national law.
LFGB: the food and feed code
The Lebensmittel- und Futtermittelgesetzbuch (LFGB) is Germany's central legislation governing food safety, food additives, feed, and consumer products. For herbal product suppliers, the LFGB establishes the legal basis for market surveillance, enforcement, and penalties. Key provisions relevant to herbal exports include the prohibition on marketing unsafe food (Section 5), the prohibition on misleading labelling (Section 11), and the requirement that food must not be harmful to health when consumed as intended.
The LFGB transposes EU Regulation 178/2002 (the General Food Law) into German national law and adds additional national enforcement mechanisms. Violations of the LFGB can result in product recalls, fines up to EUR 100,000, and criminal prosecution for serious offences involving health risk.
BfR: risk assessment
The Bundesinstitut fuer Risikobewertung (BfR) is Germany's federal risk assessment institute. BfR does not enforce law directly; instead, it produces scientific risk assessments and maximum level recommendations that the enforcement agencies (BVL and state-level authorities) use as benchmarks. For herbal product suppliers, BfR opinions matter because they frequently set de facto standards that are stricter than EU-wide rules.
The most consequential BfR positions for herbal exporters include the institute's recommendations on pyrrolizidine alkaloid limits, heavy metal maximum levels in herbal teas, and safety assessments of specific botanical substances. When a BfR opinion recommends a maximum daily intake level for a contaminant, German importers and retailers treat that recommendation as a binding threshold, even before it becomes formal law.
BVL: enforcement
The Bundesamt fuer Verbraucherschutz und Lebensmittelsicherheit (BVL) coordinates food safety enforcement across Germany's 16 federal states (Laender). Each state has its own food inspection authorities, which means enforcement intensity and interpretation can vary by region. BVL also operates the German RASFF (Rapid Alert System for Food and Feed) contact point, managing notifications of non-compliant products detected at borders or in retail surveillance.
For exporters, the practical implication is that your product may pass initial customs clearance but still face enforcement action if a state-level food inspector samples it during market surveillance. Compliance must be genuine and verifiable, not cosmetic.
EU Novel Food Regulation (2015/2283)
The EU Novel Food Regulation applies when a herbal ingredient lacks a documented history of significant consumption within the EU before 15 May 1997. The regulation requires a safety assessment and authorisation before the ingredient can be placed on the EU market. Germany applies Novel Food rules rigorously, and BVL maintains its own database of substances it considers novel.
Ingredients with established traditional use in Europe (chamomile, thyme, oregano, sage, peppermint, valerian, linden blossom) are not Novel Foods and trade freely. However, newer or exotic botanicals, unusual plant parts, or concentrated extracts may trigger Novel Food requirements. The EU Novel Food Catalogue is the first reference to check, but German authorities may apply additional scrutiny beyond the catalogue listing. Our EU market entry guide covers the Novel Food assessment process in full detail.
HMPC monographs for traditional herbal medicines
The Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency publishes monographs for herbs with sufficient evidence of traditional or well-established use. These monographs define approved indications, dosage ranges, and quality requirements for herbs that qualify for registration as traditional herbal medicinal products under Directive 2004/24/EC.
Germany has the highest number of registered traditional herbal medicines in the EU, and German manufacturers reference HMPC monographs extensively. If your customer is a German pharmaceutical manufacturer producing registered herbal medicines, your raw material must meet the quality specifications defined in the relevant HMPC monograph and the European Pharmacopoeia (Ph. Eur.) monograph for that herb.
Product classification: the critical first step
Food or tea vs dietary supplement vs traditional herbal medicine vs pharmaceutical
Before any regulatory analysis, you must determine how the German market will classify your herbal product. This classification determines which laws apply, which agencies have oversight, which labelling rules you must follow, and which claims you can make. The same dried chamomile flower can be classified under four different regulatory pathways depending on its intended use, presentation, and claims.
- Food/herbal tea: Dried herbs sold for infusion or culinary use, with no health claims beyond general statements. Regulated under LFGB and EU food law.
- Dietary supplement (Nahrungsergaenzungsmittel): Concentrated herb preparations (extracts, capsules, powders) marketed for nutritional or physiological effect. Regulated under the German Dietary Supplement Regulation (Nahrungsergaenzungsmittelverordnung, NemV) and EU Directive 2002/46/EC. Must be notified to BVL before marketing.
- Traditional herbal medicinal product: Registered under Directive 2004/24/EC with a simplified registration process. Requires 30 years of traditional use documentation (15 years in the EU). Can carry specific therapeutic indications. Sold in pharmacies.
- Pharmaceutical (full marketing authorisation): Herbal products with full clinical dossiers meeting the same standards as synthetic drugs. Rare for pure botanicals; more common for standardised extracts like ginkgo or St. John's wort extracts with clinical trial data.
Why classification determines your regulatory pathway
| Criterion | Food / herbal tea | Dietary supplement | Traditional herbal medicine | Pharmaceutical | |---|---|---|---|---| | Pre-market approval | None | BVL notification | BfArM registration | BfArM marketing authorisation | | Quality standard | EU food law | NemV + EU food law | Ph. Eur. monograph | Ph. Eur. + ICH guidelines | | Claims permitted | No health claims | Approved EU health claims only | Traditional use indications | Full therapeutic claims | | Sales channels | All retail | All retail | Pharmacy only | Pharmacy only | | Typical lead time | Weeks | 1 to 3 months | 6 to 18 months | 2 to 5 years | | Supplier documentation | CoA, phytosanitary | CoA, stability data, specifications | Full quality dossier (CTD Module 3) | Full pharmaceutical dossier |
Common misclassification mistakes
The most frequent error suppliers make is assuming that their product's classification in the country of origin determines its classification in Germany. It does not. German authorities classify based on presentation, dosage form, claims, and composition in the German market context. A product sold as a simple herbal tea in Turkey can be reclassified as a dietary supplement or even an unauthorised medicinal product in Germany if the packaging includes health claims, the dosage form suggests therapeutic intent, or the active compound concentration exceeds food-typical levels.
A second common mistake is applying dietary supplement rules to a product that German authorities consider a medicinal product by function (Funktionsarzneimittel). German case law establishes that products with pharmacological effect at the marketed dose may be classified as medicinal products regardless of how the supplier labels them. Concentrated valerian extract, high-dose artichoke extract, and certain adaptogenic preparations have all been reclassified by German courts.
Contaminant limits
Germany applies some of the strictest contaminant limits in the EU for herbal products. BfR recommendations frequently set benchmarks below EU-wide maximum levels, and German importers build these tighter limits into their purchasing specifications.
Pesticide residues (MRL)
EU Regulation 396/2005 sets Maximum Residue Limits (MRLs) for pesticides in food. The default MRL where no specific crop limit exists is 0.01 mg/kg, which functions as a near-zero tolerance threshold. German retail chains and importers often apply even lower internal limits, particularly for organic-certified products.
Turkish-origin medicinal herbs frequently demonstrate strong pesticide profiles because much of the cultivation occurs in highland zones where low-input farming is traditional practice. Geothermal drying, widely used in the Denizli and Afyon regions, avoids fumigation chemicals that can contaminate conventionally dried herbs.
Heavy metals
| Metal | EU general food limit | BfR recommendation for herbal teas | Ph. Eur. herbal drugs | |---|---|---|---| | Lead (Pb) | 0.30 mg/kg (herbs) | 1.0 mg/kg (dry matter) | 5.0 mg/kg | | Cadmium (Cd) | 0.20 mg/kg (herbs) | 0.5 mg/kg (dry matter) | 1.0 mg/kg | | Mercury (Hg) | 0.10 mg/kg | 0.10 mg/kg | 0.10 mg/kg | | Arsenic (As) | Not harmonised (EU) | Minimise exposure | 2.0 mg/kg (inorganic) |
For lead and cadmium, note that BfR applies limits to the dry matter of the herb, while some regulations reference the product as consumed (infusion). Suppliers must verify which basis their buyer's specification references.
Mycotoxins
| Contaminant | EU limit (dried herbs/spices) | Notes | |---|---|---| | Aflatoxins B1 | 5 micrograms/kg | Regulation 1881/2006, as amended | | Aflatoxins total (B1+B2+G1+G2) | 10 micrograms/kg | Sum of four aflatoxins | | Ochratoxin A | 15 micrograms/kg (spices) | Regulation 1881/2006 |
Aflatoxin contamination is a primary concern for herbs stored in warm, humid conditions. Proper post-harvest handling and storage at controlled humidity are critical, and testing at both origin and destination is standard practice for German importers.
Pyrrolizidine alkaloids: Germany's strict approach
Pyrrolizidine alkaloids (PAs) are naturally occurring toxins found in certain plant families (Boraginaceae, Asteraceae, Fabaceae) that can contaminate herbal products through co-harvested weeds. Germany has been at the forefront of PA regulation globally. BfR has recommended that daily PA intake from herbal teas and dietary supplements should not exceed 0.007 micrograms per kilogram of body weight per day, translating to approximately 0.49 micrograms per day for a 70 kg adult.
The EU set harmonised PA limits in 2022:
| Product category | PA limit | |---|---| | Herbal teas (dried product) | 200 micrograms/kg | | Herbal teas (liquid) | 1.0 microgram/kg | | Dietary supplements containing herbal ingredients | 400 micrograms/kg | | Tea (Camellia sinensis) | 150 micrograms/kg |
German importers typically apply limits tighter than these EU maximums, often requiring results below 100 micrograms/kg for dried herbal teas. Suppliers must test specifically for PAs using LC-MS/MS methodology covering the full suite of regulated PA compounds. A standard multi-residue pesticide screen does not detect PAs.
Microbiological limits
| Parameter | EU guidance limit (dried herbs) | |---|---| | Total aerobic mesophilic count | 10,000,000 CFU/g (satisfactory) | | Enterobacteriaceae | 10,000 CFU/g (satisfactory) | | E. coli | 1,000 CFU/g (satisfactory) | | Salmonella | Absent in 25g | | Listeria monocytogenes | Absent in 25g | | Yeasts and moulds | 100,000 CFU/g (satisfactory) |
These limits follow EU Regulation 2073/2005 and German DGHM (Deutsche Gesellschaft fuer Hygiene und Mikrobiologie) guidance values. Dried herbs that will undergo further processing (boiling water infusion) are subject to less stringent limits than herbs consumed directly.
Labelling requirements
German language mandatory
All food products sold in Germany must carry labelling in German. This includes the product name, ingredient list, net quantity, best-before date, origin information, storage instructions, and the name and address of the responsible food business operator (the German importer or distributor). B2B bulk shipments that are not destined for direct retail sale may carry English-language documentation for logistics purposes, but the final retail product must be labelled in German.
EU Regulation 1169/2011 compliance
The Food Information to Consumers Regulation (EU) 1169/2011 harmonises labelling across the EU and mandates specific requirements including allergen declaration, nutrition declaration, country of origin for certain foods, and minimum font sizes. For herbal products, the regulation requires the specific botanical name (genus and species) in addition to the common name, and the plant part used must be stated.
Health claims regulation (EC 1924/2006)
Health and nutrition claims on food products (including herbal teas and dietary supplements) are governed by Regulation EC 1924/2006. Only claims that have been evaluated and authorised by EFSA and listed in the EU Register of Nutrition and Health Claims may be used. Germany enforces this regulation strictly. Claims such as "supports immune function" or "aids digestion" require a specific authorised claim text linked to the ingredient at the claimed dose. Unapproved claims result in warning letters, fines, and product withdrawal.
The current state of botanical health claims in the EU is complex. A large number of botanical health claims remain "on hold" since 2012, neither approved nor rejected. German authorities generally permit the use of on-hold claims provided they are not misleading, but the situation remains legally uncertain.
Organic labelling
Products marketed as organic in Germany must carry the EU organic logo and comply with EU Regulation 2018/848 on organic production. Additionally, many German retailers and consumers look for the Bio-Siegel, Germany's national organic label, which follows the same EU standards but enjoys higher consumer recognition domestically. Organic certification must be issued by an accredited control body, and the certification number must appear on the label. Our certification guide covers the audit and verification process for quality certifications including organic.
Import process and documentation
Required documents
A complete documentation package for exporting medicinal herbs to Germany includes the following:
- Commercial invoice with full product description, HS code, country of origin, and Incoterms
- Packing list with lot numbers, net and gross weights per package
- EUR.1 Movement Certificate (or origin declaration for consignments under EUR 6,000) to claim preferential tariff rates under the EU-Turkey Customs Union
- Certificate of Analysis (CoA) issued by an accredited laboratory, covering identity, heavy metals, pesticide residues, mycotoxins, pyrrolizidine alkaloids, and microbiological parameters
- Phytosanitary certificate issued by the Turkish Ministry of Agriculture for plant-origin products
- Health certificate (if required by the specific product category or importer)
- Organic certificate (if applicable), issued by an accredited EU-recognised control body
- Bill of lading or airway bill for transport documentation
- TRACES NT notification (Trade Control and Expert System) submitted by the EU importer before the consignment arrives
For a complete overview of how to read and evaluate supplier documentation, see our CoA guide. For buyers evaluating Turkish suppliers specifically, our Turkey sourcing overview covers the end-to-end procurement workflow.
TRACES system notification
TRACES NT is the EU's online platform for managing sanitary and phytosanitary checks on imported goods. The German importer (not the Turkish exporter) is responsible for submitting a TRACES notification before the consignment arrives at the EU border. The notification triggers risk-based controls that can include documentary checks (100% of consignments), identity checks, and physical inspections including laboratory sampling.
Products that appear on the increased controls list (Regulation 2019/1793, updated regularly) face mandatory sampling at defined frequencies. Herbs from certain origins with a history of non-compliance (pesticide residues, aflatoxins, salmonella) may face 10 to 50 percent physical inspection rates. Turkish herbs are generally not on the high-risk list for most product categories, which is a meaningful logistical advantage.
Port of entry inspection
Germany's primary ports for herbal product imports are Hamburg and Bremen/Bremerhaven, with Frankfurt airport handling air freight consignments. At the port of entry, the consignment passes through the Border Control Post (BCP), where veterinary and phytosanitary inspectors review documentation and may take samples for laboratory analysis.
If the consignment passes all checks, it is released for free circulation within the EU. If non-compliance is detected, the authorities can order the consignment to be returned to the country of origin, destroyed, or subjected to special treatment (re-processing, re-labelling). The costs of these actions fall on the importer.
Customs clearance timeline
Under normal conditions, customs clearance for herbal products entering Germany takes 2 to 5 business days from vessel arrival. Documentary-only checks are typically completed within 24 hours. Physical inspections with laboratory sampling can extend clearance by 5 to 15 business days depending on the testing schedule. Importers experienced with TRACES and the BCP process can minimise delays through accurate pre-notification and complete documentation.
The preferential tariff rate under the EU-Turkey Customs Union reduces or eliminates customs duties on most dried herbs (HS codes 0910, 1211) and essential oils (HS 3301), provided the EUR.1 certificate is valid. This tariff advantage, combined with geographic proximity reducing transit time to 3 to 7 days by sea from Turkish ports to Hamburg, makes Turkey a structurally competitive origin for the German herbal market. For detailed guidance on trade terms and shipping, see our dried fruit sourcing guide, which covers logistics principles applicable to herbal shipments as well.
Frequently asked questions
Do I need to register my herbal tea product with German authorities before selling?
No, herbal teas classified as food do not require pre-market registration or notification in Germany. They must comply with LFGB and EU food law requirements at the point of sale, but there is no mandatory registration step. However, dietary supplements (Nahrungsergaenzungsmittel) must be notified to BVL before first marketing. If your product is classified as a traditional herbal medicinal product, registration with BfArM is required.
What is the difference between BfR recommendations and legally binding limits?
BfR recommendations are scientific opinions, not law. However, German enforcement agencies and courts routinely reference BfR assessments when determining whether a product is safe under LFGB Section 5. In practice, if your product exceeds a BfR-recommended maximum level, German importers will reject it and enforcement authorities may consider it non-compliant. Treat BfR recommendations as de facto binding limits for the German market.
Can I use health claims on herbal products sold in Germany?
Only health claims listed in the EU Register of Nutrition and Health Claims (authorised under Regulation EC 1924/2006) may be used. Many botanical health claims remain "on hold" and may be used provisionally, but the legal situation is uncertain. Structure-function claims, disease risk reduction claims, and any implied therapeutic claims without authorisation will trigger enforcement action. Consult your German importer's regulatory team before finalising any claim language.
How do pyrrolizidine alkaloid limits affect my chamomile or peppermint exports?
Chamomile and peppermint themselves do not contain pyrrolizidine alkaloids, but PA-containing weeds (such as Senecio species) can contaminate the harvest if field management is inadequate. German importers require PA testing on virtually all herbal tea raw materials, regardless of the botanical species. You must test each lot using LC-MS/MS methodology and demonstrate compliance with at minimum the EU limit (200 micrograms/kg for dried herbal teas), though many German buyers require results below 100 micrograms/kg.
Does the EU-Turkey Customs Union eliminate all import duties on herbal products?
The Customs Union covers industrial goods including most dried herbs, spices, and essential oils, providing zero or reduced tariff rates when accompanied by a valid EUR.1 Movement Certificate. However, certain agricultural products may fall outside the Customs Union's scope or face tariff-rate quotas. Verify the specific HS code classification for your product and confirm the applicable tariff rate with your customs broker before shipping.
Start exporting to Germany
Germany represents the single most valuable market entry point for herbal product suppliers targeting the EU. The regulatory requirements are demanding, but they are predictable and well-documented. Suppliers who invest in proper product classification, comprehensive laboratory testing, complete documentation, and German-language labelling will find a market that rewards quality and consistency with long-term purchasing relationships.
Arovela supplies medicinal aromatic herbs and essential oils to importers across Germany and the EU, backed by ISO 22000 and HACCP-certified processing, full lot-level Certificates of Analysis, and documentation packages built to meet German buyer specifications. View our certifications for audit and accreditation details.
Ready to discuss specifications and pricing for the German market? Request a quote and our export team will respond within 24 hours with a tailored proposal including COA samples, product specifications, and logistics options.