Federal Public Service - Health, Food Chain Safety and Environment
1
The regulatory system & legislation in Belgium
for food supplements with botanicals
Update of the Decree on plants
FPS Health, Food Chain Safety and Environment
DG Animals, Plants and Food
Section Service Food, Feed & other consumption products
20 April 2012 – NAREDI
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Royal decree on Plants : facts
2
- 1st publication in Belgian Official Journal
21/11/’97
- 9 decrees with adaptations
’99 - ’08
•Transposition of Directive 2002/46/EC
May 2003
•Conditions of use, specific warnings and
maximum levels for ~27 plants
March 2005
- Amending decree notified - EU COM – TRIS
April 2010
•Justification warnings - COM  + advice
July 2011
•Nat. procedure – Council of State + advice
Dec 2011
•Nat. procedure - signature 19/03/12
March 2012
 Publication Official Journal
20 April 2012 – NAREDI
4/4/2012
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Royal decree on Plants : facts
3
Justification mandatory warnings
• Based on scientific evaluation of Advisory commission
• Case-by-case assessment to ensure a high but proportional
level of consumer protection and information
• potentially adverse effects identified,
• available scientific data (+ EFSA Compendium),
• the extent of scientific uncertainty evaluated
• Measures take into account precautionary principle
• consistent with previous measures
20 April 2012 – NAREDI
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Royal decree on Plants : facts
4
Royal decree of 29/08/1997
concerning production and commercialization of
food composed of or containing plants or plant preparations
Defines:
- Lists of forbidden and authorized plants
- Notification requirements
- Requirements labeling & advertising
- Advisory Commission on Plant preparations
20 April 2012 – NAREDI
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Royal decree on Plants : scope
5
- Applies to foods and supplements that contain plants
- In annex 3 lists:
List 1:
Plants that may not be used in or as food.
 Derogation possibility
List 2:
Edible mushrooms
List 3:
Plants - predosed form. To be notified.
(*) Maximum levels
20 April 2012 – NAREDI
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Royal decree on Plants : scope
6
- Applies to foods and supplements that contain plants
- In annex 3 lists:
List 1:
Apply to all food
List 2:
List 3:
20 April 2012 – NAREDI
Only applies to Food supplements
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Actualisation of the Decree: text
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• “foodstuffs in pre dosed form”  “food supplements”
• Art. 1 – Definitions:
1° Plants: living organisms capable synthesize organic
compounds from inorganic material by means of
photosynthesis, the parasitic plants and the mushrooms;
8° Food supplements: foodstuffs the purpose of which is
to supplement the normal diet and
which are concentrated sources of nutrients or other
substances with a nutritional or physiological effect;
20 April 2012 – NAREDI
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Actualisation of the Decree: text
8
• Art. 4. § 1.
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was done
20 April 2012 – NAREDI
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Actualisation of the Decree: text
9
• Art. 4. § 2.
It is forbidden to manufacture and market food
supplements consisting of or containing one or more
plants that:
1° are not listed in list 2 and list 3 in annex to this decree
or;
2° listed in list 2 and list 3 in annex to this decree but for
which the limitations and conditions were not met,
if no prior notification to the Service was done …
20 April 2012 – NAREDI
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Actualisation of the Decree: text
10
• Art. 4. § 5. ( Notification not required for:)
3° … plant preparations in concentrated or dehydrated
form that serve for the manufacturing of soft drinks, fruit
juices and vegetable juices and of which the species are
mentioned in article 7 § 2 of Royal Decree of 19 March
2004 relating to fruit juices, nectars, fruit juices and
certain similar products;
20 April 2012 – NAREDI
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Actualisation of the Decree: text
11
• Art. 8.
Infringements of this decree are detected, identified and
prosecuted under the royal decree of 22 February 2001 on
the organization of the controls carried out by the Federal
Agency for the Safety of the Food chain
and punished according to the aforementioned law of 24
January 1977.
20 April 2012 – NAREDI
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Actualisation of the Decree: lists
12
• Transposition of the advice of the Advisory commission
- advice 2003 - 2008 = 100 advices
+ 15 plants list 1, + 50 plants list 3, Warnings, Max. levels
• Transposition of the advice of Working Group ‘Plant parts’
- Plants list 3 save & traditionally used parts mentioned
* New plants parts not forbidden but safety evaluation needed!
• Genera of list 3 replaced by specific species
- Novel Food also works species specific
(e.g. Salvia spp.)
• Check of the nomenclature of all plants
- cooperation with experts of National Botanical garden
 www.ThePlantList.org !
20 April 2012 – NAREDI
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Actualisation of the lists: past
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• List 3: genus or species (~570)
 plant parts (62)
 mandatory warnings (19)
 limited substances (12): PA, AA, estragol…
 maximum levels AI (27)
20 April 2012 – NAREDI
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Actualisation of the lists: present
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• List 3: only species (~650)
 plant parts (all plants)
+11  mandatory warnings (30)
+4
 limited substances (16): meta-synephrine
+13  maximum levels AI (40)
20 April 2012 – NAREDI
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Actualisation of the lists: maximum levels
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Brassica oleracea L. progoitrine 20 mg, goitrine 5 mg. batch/batch
Camellia sinensis
(L.) Kuntze
tannins expressed as EGCG 1600 mg.
Only the use of these solvents are allowed:
water, alcohol with a maximum amount of 25%.
Citrus aurantium L. No meta-synephrin
Maximum para-synephrin 20 mg.
Vaccinium vitisidaea L.
20 April 2012 – NAREDI
Maximum dose equivalent to 6,8 g dried leaf
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Actualisation of the lists: maximum levels
16
Glycine max (L.) Merrill
isoflavones exceeds 40 mg
(expressed as glycoside of the main
Trifolium pratense L.
Pueraria lobata (Willd.) Ohwi component).
Salix alba L.
Salix fragilis L.
Salix pentandra L.
Salicin 96 mg.
Salix purpurea L.
Zingiber officinale Roscoe
Maximum dose equivalent to 5 g of
dried rhizome
Also levels for : Urtica urens, Valeriana wallichii
20 April 2012 – NAREDI
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Actualisation of the lists: limit undesired substance
17
Borago officinalis L. 1 µg/kg toxic pyrrolizidine alkaloids
Aphanizomenon flos-aquae Possible contamination of marine
(L.) Ralfs ex Bornet &
toxins, especially micro-cystine, should
Flahault
be excluded for each batch.
Aleurites moluccana (L.)
Willd.
20 April 2012 – NAREDI
No phorbolesters
eleostearine acid content < 1%.
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Actualisation of the lists: mandatory warnings
18
Brassica oleracea
L.
- For persons with hypothyroidism or thyroid
treatment, consult your doctor
Citrus aurantium
L.
- Do not use during pregnancy or lactation
- Not for use by persons treated for hypertension
- Not for use by children under 12 years
- If signs of anxiety or nervousness, stop taking
the product
Vaccinium vitis-idaea - Do not use when pregnant or breastfeeding
L.
Cyperus rotundus L. - Do not use during pregnancy or lactation
20 April 2012 – NAREDI
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Actualisation of the lists: mandatory warnings
19
Ocimum basilicum
L.
- Do not use below 12 years
- No long-term use without professional advice
Polypodium leucatomos Poir. Not to be used by heart patients.
Calophyllum
inophyllum L.
This oil is not suitable for consumption by
vulnerable groups, in particular:
children under 12 years, adolescents under 18,
pregnant and lactating women.
Other warnings for: Nigella sativa, Juniperus communis,
Tabebuia impetignosa, Valeriana officinalis
20 April 2012 – NAREDI
Legislation on Plant food supplements in Belgium
Federal Public Service - Health, Food Chain Safety and Environment
Contact
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For questions regarding legislation on Botanicals:
Joris.Geelen@health.belgium.be
+322/524.73.82
or
0478 94 55 01
www.health.belgium.be
> Food safety > Foodstuffs > Food supplements
20 April 2012 – NAREDI
Legislation on Plant food supplements in Belgium