Plant extracts: What issues should be noted when purchasing

Plant extracts (plant/animal/microbial sources such as Curcumin, Ginseng Extract, Collagen, Probiotics, Polysaccharides, etc.) involve more complex compliance than nutritional fortifiers. Key factors include product classification as food/novel food/medicine, efficacy claim red lines, extraction process compliance, pesticide residue/heavy metal/microbial control, allergen labeling and traceability. Global regulatory differences are significant with high compliance risks. Targeted explanations are as follows.

1) First Classification: Ordinary Food Raw Material / Novel Food / Dietary Supplement / Medicine? Wrong Classification Equals Total Market Ban

There is no unified global classification standard for plant extracts; misclassification directly results in market access prohibition.

• EU: Products with pre-1997 edible history are classified as ordinary food; post-1997 new extracts require EFSA Novel Food approval (e.g. Curcumin derivatives, new Ginseng extracts). Some extracts are classified as herbal medicines and prohibited from food sales.

• US: Regulated under DSHEA as dietary supplement raw materials if with pre-1994 edible history; new extracts require NDI notification. Medical efficacy claims (e.g. cancer treatment) are strictly prohibited.

• China: Products with traditional edible habits are ordinary food; those without require National Health Commission New Food Raw Material approval (e.g. Stevia Polyphenols, Maca Extract). Some extracts (e.g. Epimedium) are classified as medicines and prohibited from food use.

• Japan & South Korea: Japan classifies into traditional food / functional labeled food; South Korea implements a health functional food raw material positive list with unlisted products banned.

• Typical Compliance Pitfalls: Red Yeast Extract permitted as a supplement in Europe and America with restricted usage in China; Garcinia Cambogia allowed in the US but banned in the EU.

Procurement Principle: Require suppliers to provide edible history certificate, target market classification document and approval certificate to confirm qualification as food/novel food/supplement rather than medicine.

2) Efficacy Claims: Global Red Line Against Medical Claims; Only Nutritional/Health Function Claims Allowed

Efficacy claim is the most common compliance pitfall for plant extracts. Global unified rule: Prohibit claims of treatment/diagnosis/prevention of diseases; only nutritional supplementation and physical function support claims are permitted.

• EU: EFSA only approves a small number of health claims (e.g. Curcumin "joint health support"); unsubstantiated claims face heavy fines.

• US: FDA strictly bans disease-related claims (e.g. hypoglycemic, anti-cancer); only structure/function claims (e.g. anti-oxidation, immunity support) are allowed with mandatory disclaimer statements.

• China: Labels are prohibited from medicinal words such as "anti-inflammatory", "anti-cancer" and "treatment"; only claims like "enhance immunity" and "nutritional supplementation" are permitted.

Procurement Action: Prohibit suppliers from marking medical efficacy on labels and promotional materials; all claims must comply with target market regulations.

3) Extraction Process & Solvent Residue: Process Compliance + Qualified Residues; Higher Risks for Alcohol/Chemical Extraction

Extraction processes (water extraction/alcohol extraction/enzymolysis/chemical extraction) directly determine compliance; excessive solvent residue is a key global inspection item.

• EU: Regulated by EC 1881/2006, Ethanol residue ≤500mg/kg, Methanol ≤50mg/kg, Acetone ≤10mg/kg; chemical extraction solvents such as Chloroform are strictly banned.

• US: FDA mandates solvent residue compliance with USP standards; alcohol extracts must label ethanol residue content.

• China: Regulated by GB 2760; extraction solvents must be food-grade with strict residue limits. Alcohol extracts carry higher compliance risks than water extracts; most water extracts qualify as ordinary food while alcohol extracts often require Novel Food approval.

• High-risk Processes: Chemical extraction (Acetone, Chloroform) and high-concentration alcohol extraction (95% Ethanol) are prone to excessive residue and banned in some markets.

Procurement Action: Require suppliers to provide extraction process description and solvent residue test reports; prioritize water extraction/enzymolysis, cautiously adopt alcohol extraction and reject chemical extraction completely.

4) Safety Impurities: Higher Risks for Pesticide Residues / Heavy Metals / Microorganisms / Mycotoxins / Allergens

As concentrated products, plant extracts amplify impurity content, leading to much higher excess rates of pesticide residues, heavy metals and mycotoxins than raw materials with zero global tolerance.

• Pesticide Residues: Plant extracts (Ginseng, Green Tea) prone to excessive pesticide residues; EU MRL standards are the strictest with strict FDA inspection in the US and full testing per GB 2763 in China.

• Heavy Metals: Botanical raw materials (Licorice, Astragalus) prone to Lead/Arsenic/Mercury excess; animal extracts (Collagen) prone to Cadmium excess with limits consistent with nutritional fortifiers.

• Microorganisms / Mycotoxins: Extracts prone to mildew and Aflatoxin excess; pathogens (Salmonella) must be undetectable.

• Allergens: Mandatory global labeling for allergens in animal extracts (Collagen, Fish Protein) and plant extracts (Soybean, Peanut).

Procurement Action: Mandatorily require full third-party testing covering pesticide residues, heavy metals, microorganisms, mycotoxins and allergens; reject supplier self-inspection reports.

5) Raw Material Traceability & Authenticity: Origin Traceability + Component Identification + Anti-adulteration; High Adulteration Risks for Extracts

Plant extracts have high adulteration prevalence (starch posing as polysaccharides, cheap plants posing as rare extracts, synthetic pigments posing as natural pigments); global authorities strictly inspect product authenticity.

• Raw Material Traceability: Must specify raw material origin, variety, picking time and planting standards (organic/conventional) with full traceability to farmers.

• Component Identification: Fingerprint spectrum (HPLC/GC-MS) + active ingredient content testing. E.g. Curcumin Extract ≥95% Curcumin content; Ginseng Extract ≥5% Ginsenoside content.

• Anti-adulteration: Mandatory third-party authenticity identification to avoid counterfeit products.

6) Production Qualifications & GMP: Food-grade GMP + Extract-specific Certification; Reject Small Workshops Directly

Production requirements for plant extracts are higher than ordinary food; food-grade GMP is mandatory with special certifications required for some markets.

• EU: EU GMP + extract-specific audit; production workshops must be clean rooms (Class 10,000 / 100,000).

• US: FDA registration + GMP (21 CFR Part 111) + dietary supplement raw material certification.

• China: SC production license (food additive/ordinary food category) covering extract varieties.

• Organic Certification: Organic claims require EU ECO, US USDA or China organic certification.

7) Labeling & Documentation: Multi-language + Full Ingredient Disclosure + Allergen Marking + Active Ingredient Content

Plant extract labeling requirements are more detailed than nutritional fortifiers with mandatory full ingredient disclosure and active ingredient content marking.

• SDS + COA: 16-section SDS required; COA specifies active ingredient content, impurities, solvent residues and allergens.

• Packaging Labeling: Must specify product name, raw material source, active ingredient content, batch number, production date, shelf life, storage conditions, allergens and manufacturer information; multi-language labeling for EU/US/local markets.

• Compliance Declaration: Stamped supplier declaration confirming compliance with target market regulations (EU Novel Food, US DSHEA, etc.).

8) Special Extracts: Additional Compliance for Probiotics / Animal Extracts / Herbal Extracts

• Probiotics: Must specify strain number, viable count (CFU/g), acid resistance and stability; EU/US require strain safety assessment.

• Animal Extracts: Mandatory quarantine certificate, disease-free area certificate and slaughterhouse qualification to prevent mad cow disease and avian influenza risks.

• Herbal Extracts: Some herbs (Ephedra, Epimedium) are globally banned or restricted; verify target market blacklist before procurement.

Summary of Plant Extract Procurement Compliance

For global B-end buyers of plant extracts, the core compliance logic is Classification Compliance → Process Compliance → Safety Compliance → Authenticity Compliance → Qualification Compliance → Claim Compliance → Documentation Compliance:

1. Classification Compliance: Confirm qualification as ordinary food/novel food/dietary supplement rather than medicine;

2. Process Compliance: Prioritize water extraction/enzymolysis, cautiously adopt alcohol extraction, reject chemical extraction and ensure qualified solvent residues;

3. Safety Compliance: Zero tolerance for pesticide residues, heavy metals, microorganisms and mycotoxins; mandatory allergen labeling;

4. Authenticity Compliance: Complete raw material traceability, fingerprint spectrum identification, active ingredient content verification and third-party authenticity testing;

5. Qualification Compliance: Suppliers must hold food-grade GMP certification, production license and special industry certifications;

6. Claim Compliance: Prohibit medical efficacy claims; only permitted nutritional/functional claims complying with target market rules;

7. Documentation Compliance: Complete set of SDS, COA, compliance declaration and multi-language labeling;

8. Special Compliance: Probiotics require strain certification; animal extracts need quarantine certificates; avoid blacklisted herbal extracts.