Botanicals

Botanicals and derived preparations made from plants, algae, fungi or lichens have become widely available on the EU market in the form of food supplements. Examples include ginkgo, garlic and ginseng. Such products are typically labelled as natural foods and a variety of claims are made regarding their possible health benefits. They can be bought over the counter in pharmacies, supermarkets, specialist shops and via the internet. While most of these products have a long history of use in Europe, some concerns exist about their safety and quality. These include the risk of chemical or microbiological contamination and the need to ensure that concentrations of active substances are within safe limits.

Latest

EFSA has released the fourth edition of the Scientific Committee’s Compendium of Botanicals, marking a major upgrade of the open-source database of plant species A subdivision of the genus, a species is a group of closely related and similar-looking organisms; for example, in the case of Homo sapiens (humans), the second part of the name (sapiens) represents the species reported to contain naturally occurring substances of potential concern for human and animal health. 

The number of plant species included totals 2,701. Among the new features the Compendium now boasts an extensive list of 1,538 naturally occurring substances of potential concern for human health. The database provides information on plants, their composition, as well as toxicity The potential of a substance to cause harm to a living organism data when available for plants and substances, drawn from published scientific articles, case and risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation reports and from state -of-the-art quantitative structure-activity relationships (QSAR) predictions (i.e. computational models).

The presence of a substance of concern in a botanical A substance, used either as a food or a medicine, derived from plants, fungi, algae or lichens does not necessarily mean that the substance poses a risk to consumer health. The database is not intended to conclude on the safety or non-safety of the listed plant species, but to help with the safety assessment of botanicals and botanical preparations by facilitating hazard identification The first step in risk assessment, this involves the identification of biological, chemical, and physical agents capable of causing adverse health effects. As such, it is a tool for scientific assessors at EFSA and in EU Member States, for risk managers at EU and national level, and for applicants/manufacturers in areas such as food supplements, novel food Foodstuff or food ingredient that was not used for human consumption to a significant degree within the European Union before 15 May 1997, and feed additives.

• External scientific report: Transformation and further development of the Compendium of Botanicals reported to contain naturally occurring substances of possible concern for human health when used in food and food supplements

EFSA's role

EFSA’s work in this field aims to provide any organisation assessing the safety of botanical ingredients with a science-based approach. It provides the criteria to take into account when undertaking work to establish the safe use of botanicals or derived preparations.

This work was initiated in 2004 when the members of EFSA’s Advisory Forum underlined the need for science-based guidance for assessing the safety of botanicals. In 2009 EFSA published a toolkit to help assess the safety of botanicals and derived preparations which are intended for use in food supplements. The toolkit is intended for both risk assessors who want to consider the safety of a given botanical ingredient Any substance deliberately added to a foodstuff which will remain in the finished product, even in an altered form, and food manufacturers who are responsible for ensuring that the products they put on the market are safe.

The toolkit is composed of:

• A guidance document identifying the data needed to assess the safety of botanicals and describing a science-based approach for the safety assessment. (The guidance document is scheduled for revision in due course.)
• A report with a number of examples illustrating how to apply the proposed scientific approach.
• A Compendium of Botanicals that have been reported to contain substances that may be of health concern when used in food or food supplements. This compendium is subject to regular updates.

EU framework

The EU does not have a centralised authorisation procedure for the use of botanicals and derived preparations in food. The authorisation and monitoring of botanicals use in food and food supplements are a national competency of EU Member States. Nonetheless, the use of botanicals and derived preparations in food has to comply with the general requirements set out in Regulation (EC) No 178/2002, which lays down the general principles and requirements of food law in the EU. This assigns primary legal responsibility for the safety of the products placed on the market to business operators. 

Depending on national legislation in place, some botanicals are considered traditional herbal medicinal plants or food supplements. The European Medicines Agency (EMA) is responsible for assessing both the safety and efficacy How well something works in relation to predefined standards or expectations of herbal preparations when used as medicines. It is not the role of EFSA or EMA to determine the classification of a botanical as a medicine or a food supplement Foodstuff containing concentrated amounts of nutrients or other substances that are intended to supplement the normal diet.

Safety assessments of botanicals

Some botanicals may require a safety assessment by EFSA under Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods. Article 8 of the Regulation provides a procedure to prohibit, restrict or place under EU scrutiny a substance other than a vitamin Dietary substance needed in very small amounts to support normal growth and maintenance of health in humans and animals. Most vitamins are 'essential' as they are not made within the body or a mineral A naturally occurring inorganic element (e.g. calcium, iron) that is needed in the diet for normal growth, development and health that is added to foods or used in the manufacture of foods. This includes the safety assessment of active substances in certain botanicals used in foods such as plant preparations. The European Commission initiates the procedure either at the request of a Member State or on its own initiative, if the conditions laid down in Regulation (EU) No 307/2012 are met. 

If a botanical intended to be used in food including food supplements does not have a history of safe use in the EU before 1997, EFSA is requested to provide a scientific opinion Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment on its safety according to Regulation (EC) No 2015/2283 on novel foods.