EN    EN EN 
 
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 5.12.2008 
SEC(2008) 2977 
 
COMMISSION STAFF WORKING DOCUMENT 
AVAILABLE SCIENTIFIC INFORMATIO N ON THE USE OF SUBSTANCES 
OTHER THAN VITAMINS AND MINERALS IN FOOD SUPPLEMENTS 
COM(2008) 824 final 
 
SEC(2008)2976 
 
EN 2   EN COMMISSION STAFF WORKING DOCUMENT 
AVAILABLE SCIENTIFIC INFORMATIO N ON THE USE OF SUBSTANCES 
OTHER THAN VITAMINS AND MINERALS IN FOOD SUPPLEMENTS 
1. THE EUROPEAN FOOD SAFETY AUTHORITY (EFSA)1 
The European Food Safety Authority (EFSA), as part of a self-task initiated in 2004 
with the aim of increasing the information available on plants and plant preparations 
used in food supplements, request ed its Scientific Committee to: 
• Analyse the available information. 
• Prepare a guidance document on how to a ssess the safety of botanicals and of 
botanical preparations to be us ed in the food and feed area. 
• Establish a list of the main categories of  botanicals and botanical preparations and 
to prioritise the products  to be considered for a safety assessment. 
Guidelines as well as a compendium of botan icals that have been reported to contain 
toxic, addictive, psychotropic or other s ubstances that may be of concern, have 
recently been finalised. These documents ai m to provide the necessary information 
with a view to harmonising the assessmen t methodology regarding the safety of the 
concerned products by the diffe rent EFSA panels. In addition, they aim to draw 
attention to the issues that would need to  be taken into acco unt when assessing the 
safety of herbal substances in foods. 
Further to this work a new mandate was given to an EFSA Scientific Cooperation 
(ESCO) working group covering the following: 
• Enlarging the information basis unde rlying the compendium, and therefore 
improving its values. 
• Prioritising botanicals for safety assessment and te sting the proposed tiered 
approach for the safety assessment of bot anicals and botanical preparations for a 
selected number of cases. 
• Providing the EFSA Executive Director with the updated compendium, a report 
summarising the outcome of the case stud ies, and giving advice on the adequacy 
of the proposed tiered approach for the safety assessment of botanicals and botanical preparations for EFSA  and Member States’ needs. 
2. C
OMMITTEE OF EXPERTS ON NUTRITION , FOOD SAFETY AND CONSUMER HEALTH OF 
THE COUNCIL OF EUROPE2 
The Committee was created in 2002 as an ad hoc group of experts on food 
supplements. 
                                                 
1 http://www.efsa.europa .eu/EFSA/efsa_locale-1178620753812_1178717026833.htm 
2 http://www.coe.int/t/e/social_cohesion/soc-
sp/public_health/nutrition_food_consumer_health/N utrition,%20food%20and%20consumer%20health_
%20EN.asp#TopOfPage 
 
EN 3   EN This ad hoc group adopted in 2005 guidelines entitled ‘Quality, sa fety and marketing 
of plant-based food supplements’. 
The aim of this work was to provide interested stakeholders with requirements that 
should be taken into account in the manufacture of safe products. 
The ad hoc group also recently drew up two other documents of interest: 
• ‘Homeostasis, a practical tool to di stinguish between foods (including food 
supplements) and medicinal products’. 
• ‘Populations possibly at risk ’ in the event of ingesti on of botanical supplements.