Commission staff working document - Available scientific information on the use of substances other than vitamins and minerals in food supplements {COM(2008) 824 final} {SEC(2008)2976}
Date: 2008-12-05
Institutions: European Commission
Subjects: approximation of laws, consumer protection, food additive, foodstuffs legislation, inorganic chemical product, vitamin

EN 

EN 

   EN 

 
 
COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 5.12.2008 
SEC(2008) 2977 

COMMISSION STAFF WORKING DOCUMENT 

AVAILABLE SCIENTIFIC INFORMATION ON THE USE OF SUBSTANCES 
OTHER THAN VITAMINS AND MINERALS IN FOOD SUPPLEMENTS 

COM(2008) 824 final 

SEC(2008)2976 

EN 

   EN 

 
 
 
 
 
COMMISSION STAFF WORKING DOCUMENT 

AVAILABLE SCIENTIFIC INFORMATION 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, requested its Scientific Committee to: 

•  Analyse the available information. 

•  Prepare  a  guidance  document  on  how  to  assess  the  safety  of  botanicals  and  of 

botanical preparations to be used 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 botanicals that have been reported to contain 
toxic,  addictive,  psychotropic  or  other  substances  that  may  be  of  concern,  have 
recently  been  finalised.  These  documents  aim  to  provide  the  necessary  information 
with a view to harmonising the assessment methodology regarding the safety of the 
concerned  products  by  the  different  EFSA  panels.  In  addition,  they  aim  to  draw 
attention to the issues that would need to be taken into account 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  underlying  the  compendium,  and  therefore 

improving its values. 

•  Prioritising  botanicals  for  safety  assessment  and  testing  the  proposed  tiered 
approach for the safety assessment of botanicals 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 studies, 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. 

COMMITTEE OF EXPERTS ON NUTRITION, FOOD SAFETY AND CONSUMER HEALTH OF 
2 
THE COUNCIL OF EUROPE

The  Committee  was  created  in  2002  as  an  ad  hoc  group  of  experts  on  food 
supplements. 

1 
2 

http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1178717026833.htm 
http://www.coe.int/t/e/social_cohesion/soc-
sp/public_health/nutrition_food_consumer_health/Nutrition,%20food%20and%20consumer%20health_
%20EN.asp#TopOfPage 

EN 

2 

   EN 

 
                                                 
This ad hoc group adopted in 2005 guidelines entitled ‘Quality, safety 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  distinguish  between  foods  (including  food 

supplements) and medicinal products’. 

•  ‘Populations possibly at risk’ in the event of ingestion of botanical supplements. 

EN 

3 

   EN