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EHPM guidance helps brands achieve best practice for botanicals

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Botanical brands face many specific challenges, from accurately identifying their wild ingredients to complying with the EU’s fragmented rules on botanical health claims. Recent guidance from the European Federation of Associations of Health Product Manufacturers (EPHM) offers tips for best practice.

Developed by technical experts from the industry, the EHPM Quality Guide, published in October, covers all aspects of food supplement production across the EU, from product concept through to manufacturing, quality control, packaging, distribution, and storage.

“The EHPM quality guide is not only about [hazard analysis and critical control points] HACCP and traceability,” said Antonino Santoro, who chairs the EHPM. “It covers all aspects of food supplement quality. Implementing [this] guide is therefore the best way for food supplements operators to ensure both the safety and the satisfaction of the growing number of European citizens who use food supplements every day.”

For safe and efficacious supplements

The quality and safety of food supplements are covered by harmonised EU legislation, and compliance is mandatory for all operators within the EU. However, the guide points out recommended procedures that go above and beyond the minimal legal requirement. It also contains several checklists to be used a practical tool, allowing companies to establish their own level of performance, or that of their suppliers or contract manufacturers, relative to the quality requirements.

While EU regulations provide a certain level playing field, the regulatory structure in place for food supplements in the EU and European Economic Area (EEA) is not entirely harmonised and there are different rules on what ingredients can be used in food supplements, and at what intake. Melatonin, for example, can be used in food supplements in Italy but is considered a medicine in Ireland.

Ensuring regulatory compliance within the single market therefore involves careful navigation – particularly regarding botanical-based supplements, as the category is highly fragmented across Europe.

Botanical regulations in EU are highly fragmented

“There is a rich history of use of botanicals in Europe. While many EU member states have extremely well-developed regulatory systems in place covering the use of botanicals in food supplements, a common EU approach still needs to be developed,” reads the report, which dedicates a special chapter specifically to botanical-derived supplements.

This lack of harmonisation has been ongoing for over a decade, according to Luca Bucchini, regulatory expert and managing director of scientific consultancy Hylobates.

“At the end of the first decade of the century, it was decided that EU member states were too far apart on how to regulate botanicals to attempt harmonisation,” he told this publication previously. “The practical implication is that the same botanical may be permitted in Italy, but not in France, for example. France may require data that Spain does not require, and Belgium may require a label warning at odds with the French requirement. As for Germany, the same product incorporating botanicals may be [regulated as] either a medicine or a food supplement.”

The conditions under which brands can make health claims for botanical ingredients also remain subject to the discretion of individual EU member states, meaning manufacturers must conduct due diligence before making health claims for products that are sold in different single-market countries.

Botanical batch testing for bioactive content

The EHPM guide outlines key quality requirements for botanicals based on existing best practice. The first step in ensuring high-quality consumer products that contain functional and active ingredients begins with the starter material: the botanical itself.

Since the chemical profile of botanical organisms are influenced by external factors, such as soil quality, mineral content of the soil, temperature, sunlight, and the time of harvesting, there can be huge variability in the composition of botanicals that enter the supply chain. Crucially for supplement brands, these environmental differences also impact the concentration of physiologically active substances.

It is therefore hugely important that suppliers test batches of botanical raw materials before accepting to process them further, concludes the guide.

“It is also particularly important that the sampling procedures used can guarantee the homogeneity and representativeness of the batch [or] lot tested,” it reads. “Testing should include identification, purity tests and assay of physiologically active constituents or other, relative quality markers.

“This is particularly important when the sourcing of the botanical is first used or changed or when there are other considerations known to affect the quality of the source material, [for example], environmental or climatic conditions, so that the risk analysis testing can, if necessary, be appropriately adapted.”

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Correctly identify wild-harvested botanicals

Correctly identifying the botanical in question may seem obvious but can be challenging, particularly for wild-harvested plants.

Brands should be rigorous in noting detailed information to correctly identify a botanical, including the scientific (Latin) name and the full systematic species name. This includes the botanical family, genus, species, variety, subspecies, author’s name, and chemotype (if applicable). Brands should also make a record of the part used, such as the root, leaf, seed, or bark.

The EHPA also recommends using authoritative sources to accurately identify some botanical sources, such as the World Checklist of Selected Plant Families or the International Plant Names Index.

Safety issues: Cross-contamination and residues

All botanical extracts that are used in food supplements must fully comply with EU food law regarding contaminants, genetically modified organisms (GMOs), irradiation, allergens, nano-ingredients, and additives. According to EU rules on contaminants, for instance, it is strictly prohibited to mix contaminated extracts with non-contaminated ones to reduce the overall contaminant levels.

There are several safety issues that require vigilance from manufacturers using both cultivated botanicals and those harvested in the wild. At the harvesting and primary processing stage, this includes cross-contamination and adulteration; foreign matter contamination (for example, pest infestation); pesticide residues; mycotoxins; and contamination with polycyclic aromatic hydrocarbons (PAHs).

As part of the risk management process, brands must have due diligence procedures in place to inspect and sort botanical materials prior to primary processing. This should include visual and organoleptic inspection of the physical characteristics, says the EHPA.

“However, the adequacy of such inspection depends on the form of the botanical material (cut size) and the level of expertise of the supervisor. This is why complementary testing is necessary to confirm the identity of the botanical material. [...] Any plant parts showing signs of fungal/mould growth should be discarded,” write the report authors.

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