Plant Extracts in the Food Industry and Safety Standards

Plant extracts are increasingly used as functional foods, supplements and natural preservatives. This situation is closely associated with strict safety assessments, "novel food" rules and additive legislation in many countries, above all in the EU.

For food to be safe, traceability and systems based on hazard analysis (HACCP and the like) are a basic requirement. Where plant extracts form part of a food, they are subject to general food legislation. In the EU, if there was no significant consumption before 15 May 1997, they fall within the scope of Regulation (EU) 2015/2283 as a "novel food", and an EFSA risk assessment together with Commission pre-market authorisation is required.

Basic Safety Data for Plant Extracts

For plant extracts to be assessed safely and to a consistent standard, certain technical and scientific data must be set out in detail.

1. Identity and Composition

For the identity and composition of plant extracts to be defined correctly, the full scientific name of the plant used, the family it belongs to, its geographical origin, the time of collection and whether it was obtained from cultivation or from a wild population must be stated in detail. The plant part used (leaf, root, bark and so on) must also be clearly defined.

Regarding the production process of the extract, the solvent or solvent mixture used (water, ethanol, hydroalcoholic systems and so on), the drug-to-solvent ratio, the extraction method (maceration, percolation, Soxhlet and so on), temperature, time, pressure and any pre-treatments (fermentation, purification and so on) must be detailed.

In terms of composition, the purity of the extract, the quantities of active or marker compounds and their chromatographic profiles (HPLC, HPTLC, GC and so on) must be reported, and where possible standardisation should be carried out on the basis of these constituents. Such detailed definitions are regarded as fundamental to ensuring the quality, efficacy and reliability of the product.

2. Production Process

The industrial production process for plant extracts has a multi-stage structure aimed at obtaining a standard and safe product.

The process consists of raw material selection, quality control, extraction, purification and final quality verification steps. GMP, HACCP and quality management systems must be actively applied at these stages.

The methods and parameters used at the extraction stage (temperature, time, solvent ratio and so on) directly affect the quality of the product. Alongside this, active constituent monitoring, impurity control and batch consistency must be maintained throughout production.

3. Exposure Assessment

Exposure assessment is an important parameter in the safe use of plant extracts.

The food categories in which the extract will be used and the levels at which it will be used are determined. These data are evaluated together with consumption habits and daily intake amounts are calculated.

The resulting values are compared with toxicological limits and a safe range of use is established.

4. Toxicological Assessment

The safety of plant extracts must be supported by toxicological testing.

Within this scope genotoxicity tests and cellular analyses are carried out. The data obtained are used in determining the risk profile of the product for human use.

5. Nutritional Effect

The effect of the extract on nutrition must be evaluated and it must be confirmed that it causes no adverse effect at the recommended levels of use.

Safety Standards and Assessment Elements

In the safe use of plant extracts, various quality parameters such as pesticide residues, heavy metals, solvent residues and microbiological criteria are taken into account.

Alongside this, the species of the plant, the growing conditions and the processing method can make standardisation more difficult. In concentrated extracts, dose and duration of use are also among the critical factors.

Application, Labelling and Post-Market Control

Labelling is an important part of safe use in products containing plant extracts.

The plant name, extract type, content information and instructions for use must be clearly stated on labels. Health and nutrition claims must be supported by scientific data and must comply with the relevant legislation.

In some countries products are also monitored after being placed on the market and risk-based inspections are applied.

Conclusion

The use of plant extracts in the food industry is not limited to the product development process alone. It also requires a comprehensive safety assessment and regulatory compliance.

Correct definition of identity and composition, controlled production, toxicological assessment, exposure calculations and correct labelling form the basis of safe use.

Particularly in markets where regulation is intensive, such as the European Union, it is not possible to place products on the market without the necessary data sets and pre-market authorisations.