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Decision of 15 March 2003, laying down rules on food supplements (WarenwetDecree food supplements)
We Beatrix, at the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc. etc. etc.
On the nomination of the Secretary of State for Health, Welfare and Sport of 29 November 2002, VGB/VL 2335168, made in accordance with Our Ministers for Agriculture, Nature Management and Fisheries, of Economic Affairs and of Justice;
Having regard to:
- Directive No 2002 /46/EC of the European Parliament and of the Council of the European Union of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (PbEG L 183), and
- Article 4, first paragraph, points (a) and (c) , Article 6 (d) , Article 8, first paragraph, points (a) and (c) , Article 13 (a) , Article 14 , and Article 32b, 1st paragraph, of the Warenwet ;
The Council of State heard (opinion of 6 February 2003, No. W13.02.0549/III);
Having regard to the further report of the Secretary of State for Health, Welfare and Sport of 11 March 2003 with number VGB/VL 2361770, expressed in agreement with Our Ministers for Agriculture, Nature Management and Fisheries, of Economic Affairs, and of Justice;
Have found good and understand:
1 In this Decision and the provisions based thereon, the following definitions shall apply:
a. micronutrients : vitamins and minerals;
b. food supplements : eating or drinking products which:
1 ° are intended as a supplement to the normal diet;
2 ° shall be a concentrated source of one or more micro-nutrients or of other substances having a nutritive or physiological effect; and
3 ° are traded in measured small unit units intended for intakes;
c. Directive 2002 /46/EC : Directive No 2002 /46/EC of the European Parliament and of the Council of the European Union of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (PbEG L 183);
ed. Regulation (EU) No 1169/2011 Regulation (EU) No Council Regulation (EC) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers amending Regulations (EC) No 142/2011 1924/2006 of the product (EC) Parliament and Council Directive 87 /250/EEC, Council Directive 90 /496/EEC, Commission Directive 1999 /10/EC, Directive 2000 /13/EC of the European Parliament and of the Council, Directives Commission Directive 2002 /67/EC and 2008 /5/EC, and Regulation (EC) No 313/EC, Commission Regulation (EC) No 608/2004 (PbEU 2011, L 304).
2 This Decision shall not apply to medicinal products referred to in Article 1, first paragraph, point (b) of the Pharmaceutical Act .
1 It shall be prohibited to prepare or market food supplements which do not comply with the requirements laid down in or pursuant to this Decision with regard to their composition.
2 It is prohibited to offer food supplements to the final consumer for sale, sale or delivery other than as pre-packaged food as referred to in point (e) of Article 2 of Regulation (EU) No 1169/2011.
3 It is prohibited to trade food supplements other than in compliance with the requirements laid down in this Decision with regard to their designation.
4 It is prohibited to trade food supplements other than in compliance with the requirements laid down in or pursuant to this Decision with regard to the use of indications or representations of the nature, composition, status, characteristics or destination of the commodity.
1 By way of a regulation of our Minister for implementation of Article 4, first paragraph, of Directive 2002 /46/EC , the micronutrients and their compounds, which may only be used in the preparation of food supplements, are used.
2 Under the arrangements of Our Minister for the implementation of: Directive 2002 /46/EC the purity criteria laid down for the micronutrients referred to in the first paragraph are adopted.
3 Under the conditions of Commodity law The criteria of purity laid down for micronutrients referred to in paragraph 1 which are used in the preparation of food and drinking products other than food supplements shall apply mutatis mutandis in the preparation of food supplements.
To be placed under the rules of our Minister for the implementation of Article 5 (4) of the Directive 2002 /46/EC measures taken, the quantities of vitamins and minerals laid down, which are in food supplements:
a. at least be present; and
(b) may be present at most.
The designation food supplement It should be used exclusively for food supplements.
1 Without prejudice to Regulation (EU) No 1169/2011, food supplements shall include entries concerning:
a. the designation of the categories of micronutrients or substances having the characteristics, or information about the nature of these micronutrients or substances;
b. The recommended daily portion of the commodity;
c. A warning for exceeding the recommended daily portion;
d. an indication that food supplements are not used as a substitute for a varied diet; and
e. a warning that food supplements should be kept out of reach of young children.
2 When setting the recommended daily portion, account will be taken of the Article 4 quantities referred to.
3 In food supplements no entries claim or suggest that a balanced and varied diet may in general not provide appropriate amounts of micronutrients.
4 By arrangement of Our Minister for the implementation of pursuant to Article 7 of Directive 2002 /46/EC the measures taken in respect of the second and third paragraphs have been adopted.
1 The amount of micronutrients or substances present in a dietary supplement with a nutritive or physiological effect shall be indicated in the labelling of the commodity in a number. This entry;
a. refers to the recommended daily portion of the pore; and
b. is expressed as a percentage of the reference intakes as referred to in Part A of Annex XIII to Regulation (EU) No 1169/2011.
2 The quantity referred to in the first paragraph of the first paragraph shall be an average based on the analysis of the quantity used by the manufacturer concerned.
3 Without prejudice to the first paragraph, point (b), the percentage of reference values for vitamins and minerals referred to therein may also be expressed in graphic form.
4 By arrangement of Our Minister for the implementation of Article 8, first paragraph, and Article 9, first and second paragraph, of Directive 2002 /46/EC the measures taken, detailed rules relating to the first, second, or third members.
1 This Decision shall enter into force as from the day following the date of issue of the Official Journal in which it is placed.
2 By way of derogation from the first paragraph Article 2 and Article 8 in effect from 1 August 2005.
3 Article 3, fourth paragraph , shall expire on 31 December 2009.
This decision is cited as: WarenwetDecree food supplements.
Charges and orders that this Decision will be placed in the Official Journal by means of the note of explanatory note accompanying it.
' s-Gravenhage, 15 March 2003
Beatrix
The Secretary of State for Health, Welfare and Sport,
C. I. J. M. Ross-van Dorp
Issued the first April 2003The Minister of Justice, a.i.,
H. P. A. Nawijn
