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Most important Dutch and EU Regulations ans Directives
- Herbal Products / Herbal Medicinal Products
European Directive Food Supplements 2002/46/EC - 10 June 2002
Only vitamin and mineral subsntances as mentioned on the new annex 2 are allowed
Discussion Paper on the setting of minimum and maximum levels vitamins and minerals in foodstuffs - June 2006
WHO Codex for Food Supplements - July 2005
Dutch Food Law Herbal Products - 19 January 2001
Directive 2001/83/EC relating to medicinal products - 6 November 2001
Directive 2004/24/EC amending 2001/83/EC regarding Traditional Herbal Medicnal Products - 31 March 2004
By Thomans Brendler a guideline for THMPD regsitration is published in 2011: see http://www.thmpd.eu/publications/
Directive 1999/83/EC relating to analytical, pharmacotoxicological and clinical standards and
protocols in respect of the testing of medicinal products - 8 September 1999
Substances/products are not a Novel Food when they were significantly on the market in at least one EU country before May 15, 1997.
Novel Foods are only allowed after approval by National authorities after a safety assessment. Also a new technology or new extractionprocedure can make a product into an un-approved Novel Food.
For traditional products outside of the EU with a long history of safe use the European Commission will use less strict requirements.
The EU published a Novel Food catalogue, which will give an overview of substances/products/ingredients/plants that have been discussed within the EU whether they are a Novel Food. The result is a list in 4 groups:
1. products that are not a novel food because they were on the market before May 15, 1997 in the EU
2. products not on the market before May 15, 1997 and which are not allowed
3. products under investigation, not sure if they belong to 1. or 2.
4. substances that were used in foodsupplements before May 15, 1997 and are ONLY allowed in
The Novel Food Catalogue is far from complete. If a substance or plant is not mentioned in this catalogue it just means that the EC did not yet review it!
Directive Novel Foods 258/97/EC - January, 27 1997
Dutch Regulation regarding fortification of foods with vitamins and minerals
(will be replaced by EU Regulation in 2007)
Correcting of art 5 addition of foliumacid and Vit D - January 2007
Regulation on the addition of vitamins and minerals to foods 1925/2006/EC - 20 december 2006
Nutrition- and Health Claims
Selfregulation guidelines: KAG-Leidraad
Regulation 1924/2006/EC on Nutrition and Health Claims- 20 December 2006
Regulation 432/2012: approved health claims, May 2012
Regulation 536/2013 extra permitted claims, 12-06-2013
EFSA opinions: see EFSA website
In 2012 the EC published (can be found on the EU website) on hold lists for botanicals and non-botanicals.
Only claims on the on hold lists for botanicals and permitted health claims for all other ingredients are allowed since end of 2012!
Codex Guidelines for use of Nutrition and Health Claims - July 2004
Directive 2007/68/EG, amending Annex IIIa to directive 2003/89/EC, 27 november 2007
Directive 2005/63/EC, correcting of 2005/26/EC, 3 October 2005
Directive 2005/26/EC, Labelling of Allegens, 21 March 2005
Directive 2003/89/EC, Annex IIIa, 10 November 2003
Dietary foods for special medical purposes (Parnuts): medical food, dietetic food
Proposal for a Regulation on food intended for infants and young children and on food for special medical purposes
Directive 2009/39/EC - 6 May 2009 on foodstuffs intended for particular nutritional uses (recast)
Repealed: Council Directive 89/398/EEC; Directive 96/84/EC; Directive 1999/41/EC and Regulation (EC)
No 1882/2003 (pn 15 of Annex III only).
Directive 2006/34/EG - 21 March 2006 (amending the Annex to Directive 2001/15/EG)
Directive 2001/15/EG - 15 February 2001 (consolidated), on substances that may be added for specific
nutritional purposes in foods.
Directive 1999/21/EG - 25 March 1999 ,on dietary foods for special medical purposes
Directive on foodstuffs intended for particular nutritional uses 2004/0090 (COD) - 22 April 2004
Directive 96/84/EG - 19 December 1996 (amending 89/398/EEG), repealed 6 May 2009
Directive 1999/41/EEG - 7 June 1999 (amending 89/398/EEG), repealed 6 May 2009
Directive 89/398/EEG - 3 May 1989, repealed 6 May 2009
All companies that bring food supplements on the EU market must have a HACCP system, by which the safety of the product and all product processes are disucssed and secured. Rivendell has a simple, adequate HACCP system for distributors of food supplements.
Decision 768/2008/EC, 9 juli 2008
This Decision lays down common principles and reference provisions intended to apply across sectoral legislation in order to provide a coherent basis for revision or recasts of that legislation.
Regulation 764/2008/EC, 9 juli 2008
This Regulation is laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State.
Regulation 765/2008/EC, 9 juli 2008
This Regulation is setting out the requirements for accreditation and market surveillance relating to the marketing of products.
Import, especially from the US
As the EU is making its laws and regulations more and more restrictive regulations for food supplements
it is for companies from the US getting more difficult to export US food supplements to the EU. The biggest gaps are in the maximum daily dosages for most vitamins to most EU countries (except the UK and the Netherlands) and the since end 2009 in force list of approved vitamin and mineral subtances. Most chelated minerals are not on the EU list. Also regarding new or rare herbal ingredients it is quite possible that they are seen as a Novel Food in the EU.
Rivendell has selected the above laws and regulations with the intention that this gives a good view regarding the legal aspects for these type of products. However it is possible that texts are meanwhile amended, in that case the most recent version including the amending must be used. For the correct interpretation of laws and regulations also the existing practice in a memberstate of the EU can be of influence. Rivendell can only have responsibility for the use and interpretation of above overview and legal texts after all legal aspects and the practice regarding a product have been examined carefully and are written down in a report by Rivendell.
With respect to the correctness of the on-line legal texts Rivendell refers to the important legal notice of
the European Commission in which they do not accept responsibility or liability. Only European Union
legislation published in paper editions of the Official Journal of the European Union is deemed authentic.
A consolidated document is one easy to read, non-official document, which is a combination of several legal texts, that is officially published in ‘The Official Journal of the European Communities'.