federal public service - health, food chain safety and environment 20 april 2012 –...
TRANSCRIPT
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
1 The regulatory system & legislation in Belgium
for food supplements with botanicals
FPS Health, Food Chain Safety and Environment
DG Animals, Plants and FoodSection Service Food, Feed & other consumption products
Update of the Decree on plants
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
2
Royal decree on Plants : facts
- 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 March 2005maximum levels for ~27 plants - 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 4/4/2012
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
3
Royal decree on Plants : facts
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
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
4
Royal decree on Plants : facts
Royal decree of 29/08/1997concerning 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
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
5
Royal decree on Plants : scope
List 1:
List 3:
Plants that may not be used in or as food.
Derogation possibilityEdible mushrooms
Plants - predosed form. To be notified.
(*) Maximum levels
List 2:
- In annex 3 lists:
- Applies to foods and supplements that contain plants
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
6
Royal decree on Plants : scope
Apply to all foodList 1:
List 3:Only applies to Food supplements
List 2:
- In annex 3 lists:
- Applies to foods and supplements that contain plants
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
7
Actualisation of the Decree: text
• 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;
• “foodstuffs in pre dosed form” “food supplements”
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
8
Actualisation of the Decree: text
• Art. 4. § 1.
It is forbidden to manufacture and market foodstuff in pre dosed form, consisting of or containing one or more plants that are listed in list 2 and list 3 in annex to this decree if no prior notification to the Service was done
• Art. 4. § 1.
It is forbidden to manufacture and market food supplements, consisting of or containing one or more plants or plant parts that are listed in list 2 and list 3 in annex to this decree if no prior notification to the Service was done
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
9
Actualisation of the Decree: text
• 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 …
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
10
Actualisation of the Decree: text
• 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;
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
11
Actualisation of the Decree: text
• 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.
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
12
Actualisation of the Decree: lists
• 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
• Transposition of the advice of the Advisory commission- advice 2003 - 2008 = 100 advices+ 15 plants list 1, + 50 plants list 3, Warnings, Max. levels
www.ThePlantList.org !
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
13
•List 3: genus or species (~570)
plant parts (62)
mandatory warnings (19)
limited substances (12): PA, AA, estragol…
maximum levels AI (27)
Actualisation of the lists: past
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
14
•List 3: only species (~650)
plant parts (all plants)
+11 mandatory warnings (30)
+4 limited substances (16): meta-synephrine
+13 maximum levels AI (40)
Actualisation of the lists: present
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
15
Actualisation of the lists: maximum levels
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%.
Brassica oleracea L.
progoitrine 20 mg, goitrine 5 mg. batch/batch
Citrus aurantium L.
No meta-synephrin Maximum para-synephrin 20 mg.
Vaccinium vitis-idaea L.
Maximum dose equivalent to 6,8 g dried leaf
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
16
Actualisation of the lists: maximum levels
Glycine max (L.) Merrill
isoflavones exceeds 40 mg (expressed as glycoside of the main component).
Trifolium pratense L.
Pueraria lobata (Willd.) OhwiSalix alba L.
Salicin 96 mg.Salix fragilis L.
Salix pentandra L.
Salix purpurea L.
Zingiber officinale Roscoe Maximum dose equivalent to 5 g of dried rhizome
Also levels for : Urtica urens, Valeriana wallichii
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
17
Actualisation of the lists: limit undesired substance
Aphanizomenon flos-aquae (L.) Ralfs ex Bornet & Flahault
Possible contamination of marine toxins, especially micro-cystine, should be excluded for each batch.
Borago officinalis L.
1 µg/kg toxic pyrrolizidine alkaloids
Aleurites moluccana (L.) Willd.
No phorbolesterseleostearine acid content < 1%.
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
18
Actualisation of the lists: mandatory warnings
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 L.
- Do not use when pregnant or breastfeeding
Brassica oleracea L.
- For persons with hypothyroidism or thyroid treatment, consult your doctor
Cyperus rotundus L.
- Do not use during pregnancy or lactation
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
19
Actualisation of the lists: mandatory warnings
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.
Ocimum basilicum L.
- Do not use below 12 years - No long-term use without professional advice
Other warnings for: Nigella sativa, Juniperus communis,
Tabebuia impetignosa, Valeriana officinalis
Federal Public Service - Health, Food Chain Safety and Environment
20 April 2012 – NAREDI Legislation on Plant food supplements in Belgium
20
For questions regarding legislation on Botanicals:
+322/524.73.82 or 0478 94 55 01
www.health.belgium.be > Food safety > Foodstuffs > Food supplements
Contact