Masterstudiengang "Drug Regulatory Affairs"


Evaluation and safety assessment of botanical preparations intended for the use in food supplements ***

Dr. Annette Mayer (Abschlußjahr: 2009)

Language: English

Food supplements are defined as food intended to supplement the normal diet. They are concentrated sources of vitamins, minerals or “other substances with a nutritional or physiological effect” - which might for example be derived from plants. The number of food supplements containing botanicals or botanical preparations to be referred to as botanical food supplements - is strongly increasing on the European market. The consumer believes in the beneficial health effects of the concerned plants and has the opinion, that “natural” means “safe”.

However, botanical food supplements cannot a priori be assumed to be harmless and a comprehensive safety assessment is necessary to ensure the safety of the product.

The risk operator needs a detailed knowledge of the legal framework of food supplements, the principles of the safety of food and food supplements and all parameters that are important for a comprehensive safety assessment:
  1. The European Commission (EC) defined food supplements for the first time by the Directive 2002/46/EC which was implemented in Germany with the Food Supplements Ordinance „Verordnung über Nahrungsergänzungsmittel“ (NemV) in 2004. The EC also defined there that food supplements mean foodstuffs, with the consequence that the risk operator has to additionally consider the General Food Law with the Regulation 178/2002/EC. Further legislation also has to be taken into consideration if applicable. This might be the Novel Food Regulation or Health Claims Regulation.
  2. It is important to know that Directive 2002/46/EC and NemV permit besides vitamins and minerals - „other substances with a nutritional or physiological effect“ in food supplements.
    However, no definition of what „other substances“ are, and no positive lists exist. The European Member States pursue different policies ranging from liberal to restrictive regarding the acceptance of „other substances“ in food supplements leading to uncertainty for business operators as to whether the concerned food supplement will be accepted or not. For example Germany follows a restrictive policy, especially in view of botanical extracts which are quite often classified as drugs by the authority.
    It has to be pointed out that this master thesis focuses on safety assessment, therefore the topic of classification as food supplement or medicinal product is just noted in the margin.
  3. The food safety requirements are defined in the Regulation 178/2002/EC laying down the general principles and requirements of food law, establishing the European Food Safety Authority and procedures in matters of food safety. An important factor to take account of is that the legal responsibility for ensuring the quality and safety at all stages of the food production chain stands with the operator.
    This is also the case for food supplements as they belong to food. Hence, the business operators are responsible for the food supplement they place on the market, assuming the burden of proof in relation to their safety. Therefore, it is essential that a safety assessment should be performed by the business operators.
  4. Potential contamination with heavy metals, pesticides, microorganisms and mycotoxins has to be evaluated with respective maximum limits. Additionally, allowance of food contact material, flavourings and additives and the application of irradiation might be relevant. These are parameters the business operator also has to consider in his comprehensive safety assessment.
  5. It should be pointed out that botanical food supplements in comparison to, for example vitamin food supplements, require additional safety aspects to be considered.
    Firstly, substances commonly occurring at low levels in botanical food might be extracted and consumed at much higher levels in specific products than in a normal diet. Therefore, an assessment in view of selective enrichment of substances, which may have pharmacological or toxicological effects, is essential.
    Secondly, the identity of the concerned plant has to be ensured to rule out adulterations or mistakes during harvest or manufacturing.
    Thirdly, variability in composition of the substances can lead to large differences in concentrations of specific compounds. Therefore it has to be guaranteed that the concentrations of bioactive agents, as well as of naturally occurring toxic substances meet specifications and are within safe limits.
In the last few years concern regarding safety of botanical food supplements has increased resulting in the publication of several guidances by different organisations. Due to the high priority of food safety in EU policy, and due to the increased popularity of botanical food supplements, the European Food Safety Agency (EFSA) was recently requested by the Member States to work on a harmonised guidance for safety assessment. In 2008 the EFSA published the draft guidance “Safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements” introducing a new two-level approach for data requirements and a compendium that contains plants which may deserve special attention. The guidance focuses on safety and quality parameters and wants to be a useful tool for risk operators to perform safety assessment of botanical food supplements.

However, the EFSA´s guidance does not discuss hazards by contaminations or other important issues like the allowance of additives etc., parameters the business operator also has to consider in a comprehensive safety assessment.
Therefore, the business operator has to consider several Directives and Regulations besides the EFSA guidance. This is a complex and complicated evaluation of all necessary safety aspects with a risk of unintentionally missing essential issues as the result of the assessment depends mostly on the experience of the risk operator. The EFSA´s guidance is a first step to harmonise safety assessment of botanical food supplements on the European level, however the business operator still has to complete his “tool box” of applicable legislation and guidances by himself. Therefore, a complete and updated list of guidelines and legislation that might be relevant for safety/quality/risk assessment should be linked to the EFSA guidance.

The present master thesis is focusing on the safety assessment of botanicals or botanical preparations used as an ingredient in food supplements. A complete overview of current legislation and necessary data and information for safety assessment are presented. Additionally, a checklist has been developed to control the availability of this data. It helps to evaluate the risk and safety of the product with subsequent options for activities by the business operator.

Therefore, this master thesis can be used as a multifunctional tool box for a comprehensive safety assessment of botanical food supplements.

Pages: 60

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