The safety and quality of botanicals are closely interrelated and apply from the beginning of the manufacturing process. Correct plant identification, raw material control and avoiding any inadvertent adulteration of the raw material are of paramount importance. Potential contamination from pesticides, mycotoxins or toxic metals – such as lead or cadmium – must also be avoided. European food law sets out specific levels that must be met, which are often stricter than those for medicines.
Since its creation, Food Supplements Europe (FSE) has committed to helping its members apply complex regulatory frameworks to ensure that food supplements are safe and of the highest quality.
By bringing the knowledge and expertise of leading companies together with that of national food supplements associations, Food Supplements Europe has a strong basis for developing tools and guidelines that are of value to its members and, in particular, the numerous small and medium-sized companies that operate in the EU. The focus on quality is also important for products intended for export, and companies looking to import products into the continent will be scrutinised using the same standards.
The legislation governing the EU’s food sector
In the EU, the safety of food supplements is governed by a whole body of legislation. These consist of pre-market authorisation procedures for products like novel foods, additives and nutritional substances; positive or negative lists of compounds permitted for use in food supplements – mostly at national level – including conditions of use, maximum levels – for contaminants and residues – and requirements for labelling, and the use of nutrition and health claims.
For manufacturing, the rules are also extensive and covered by hygiene legislation; however, they are generalised for most food categories. This body of legislation is therefore complemented by guidance documents created by various food sectors.
FSE has developed a number of publications and tools to help manufacturers identify and apply necessary measures to reach the expected level of quality. Its guidelines include the Good Manufacturing Practice for Manufacturers of Food Supplements (GMP) and Quality of Botanical Preparations (QBP), which both have accompanying self-assessment questionnaires.
The right guide
The GMP covers all aspects of manufacturing food supplements, from the incoming raw materials to the outgoing goods, and the perspective of EU legislation and the requirements for good manufacturing practice, based on the principles of hazard analysis and critical control points (HACCP), which underlie EU hygiene legislation. It covers the complete cycle of production and quality control of a food supplement, from the acquisition of all materials through all stages of subsequent processing, packaging and storage to the distribution or release of the finished product. As such, relevant sections of the document also apply to food supplement companies that use contract manufacturing for items or to those that are the sole distributors of products.
It is a legal obligation to have a comprehensive system in place that is designed, documented, implemented and controlled, and provided with personnel, equipment and other necessary resources to ensure products will be safely and consistently manufactured for their intended use. All businesses along the food supplement supply chain should take quality seriously and guarantee that all relevant sections are complied with.
The guidelines specifically cover aspects of importance for training personnel, the maintenance of premises and manufacturing equipment. Of particular note is the verification of the product development process that ensures safety, stability, and the legality of composition and labelling, including using health claims. Detailed requirements for quality control in the manufacturing process and the stability of testing to determine shelf life are also provided alongside emergency procedures – such as recall and withdrawal – and complaint handling. In addition, a specific chapter addresses contract manufacturing and the document also provides examples of HACCP control charts, which are very helpful for companies assessing their performance in this area.
This guidance is the European equivalent of the International Alliance of Dietary/Food Supplement Associations (IADSA)’s Global Guide to Good Manufacturing Practice for Supplements, which was published in 2011.
Better botanicals
To address the specificities of botanicals, FSE has also developed the QBP. While the more general principles of quality and safety are covered by the GMP, this publication addresses the particular aspects of botanical extracts, as they have very strict requirements for their identification and manufacturing. This guideline was developed with the help of experts in botanical product manufacturing.
The most critical aspect for the quality – and safety – of botanical preparations is the correct identification of the plant, including knowing its origin and the fact it has been cultivated or collected in accordance with good agricultural and collection practices (GACP). Also, knowledge about the treatment the source material has undergone is critical for preventing many issues during and after production.
For some plants, specific safety issues exist that need to be addressed in the HACCP and quality system, such as the possible cross-contamination with species that look similar but have a different safety profile. In addition, substances of concern need to be addressed by appropriate quality measures to ensure safe final products.
EU legislation contains specific provisions for contaminants and residues that need to be verified – and microbiological quality also needs to be ensured. In the EU, it is not permitted to irradiate plants that are intended for use in food supplements.
Another aspect addressed by the guide is the quality of extracts and their preparation. A botanical extract is a complex product, with a composition and chemical profile that is mainly determined by the quality and natural variability of the raw material, and the extraction process applied. To ensure consistent quality, it is necessary to determine the specifications of the production process and the final extract. For changes in raw materials or processing parameters, the verification of conformity with the specifications must be reassessed and, where appropriate, the necessary modifications applied.
Key parameters that support the equivalence between two extracts are the solvent and extraction conditions, as well as the ratio of the starting plant material to the final extract, which is considered as a range related to the natural variability of the plant material. This is of importance to the supplement manufacturer, which may have to make significant changes to a product’s formula to accommodate an alternative source of extract. Specific aspects, such as market determination and extract ratio, are therefore covered in detail.
Finally, the QBP also contains practical and hands-on information relating to the practicalities of quality control.
Of critical importance is the product’s documentation, and the manufacturing process steps that must be collected and maintained. This information should cover every aspect of the product in detail, from the agreed specifications for the raw botanical material through to the release for sale of the extract. This documentation should include a specification sheet, a flow chart, and the results of analytical testing and process monitoring. Without proper documentation, the company will not be able to demonstrate that all measures identified in its HACCP system have been carried out and are efficient.
A true test of quality
Two self-assessment questionnaires accompany the guides and have been developed as a checklist to help manufacturers identify the necessary documentation needed throughout the supply chain to ensure that their products are high quality and safe.
These tools are the result of the demand for easy-to-use documents, helping the FSE’s members and other companies apply the multitude of regulatory requirements applicable to food supplements. They allow manufacturers to verify if they have covered all aspects and are in possession of the necessary documentation to ensure legal compliance.
We are confident that the selfassessment questionnaires are an essential tool for companies that are committed to show they manufacture safe and highquality products, and can help enforcement authorities identify aspects of importance. It is especially valuable for small and medium-sized companies. We recommend all companies in this area test and apply the questionnaires to rate their own performance and identify where improvements are needed.
In conclusion, the FSE’s guidelines and assessment tools identify, in a practical way, the aspects that require specific attention and control. The association is a vast repository of measures that can be used by companies to ensure that their products are safe and of high quality. It is recommended that businesses make use of these documents, if they are manufacturing food supplements for marketing in the EU.
