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1. ------IND- 2004 0534 CZ- EN- ------20050105 ------PROJET
Draft
DECREE
of ...... 2004
on foodstuffs intended for particular uses and on their method of use
Having regard to Article 19 Paragraph 1 a) and i) of Act No.. 110/1997 Sb., on food and tobacco products and amending and supplementing several related acts, the Ministry of Health has determined in the wording of Act No. 306/2000 Sb., Act No. 274/2003 Sb. and Act No. 316/2004 Sb., hereinafter referred to only as “the Act”,:
Article 1
Decree No. 54/2004 Sb. on foodstuffs intended for special use and on their method of use shall be amended as follows:
1.The note under point 1) shall read:
“ 1) Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses, in the text of Directive 96/84/EC and Directive 99/41/EC.
Commission Directive 2001/15/EC of 15 October 2001 on substances that may be added
for specific nutritional purposes in foods for particular nutritional uses, in the text of Directive 2004/5/EC.
European Parliament and Council Directive 2000/13/EC of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs.
Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and
follow-on formulae, in the text of Directive 96/4/EC, Directive 1999/50/EC and Directive 2003/14/EC.
Directive 1996/5/EC of 16 February 1996 on processed
cereal-based foods and baby foods for infants and young children, in the text of Directive 98/36/EC, Directive 99/39/EC and Directive 2003/13/EC.
Council Directive 92/52/EEC of 18 June 1992 on infant formulae and
follow-on formulae intended for export to third countries.
Commission Directive 96/8/EC of 26 February 1996 on foods intended for use
in energy-restricted diets for weight reduction.
Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical
purposes.
Commission Directive 2004/6/EC of 20 January 2004 derogating from Directive 2001/15/EC to postpone the application of the prohibition of trade to certain products.”
2.In Article 18 Paragraph 2 shall read:
“(2) Gluten-free foodstuffs shall be taken to mean:
a)foodstuffs, which consist of or are produced solely from raw materials which do not contain any ingredients from wheat or other types of Triticum such as spelt (Triticumspelta L.), Polish wheat (Triticum polonicum L.) or hard wheat, barley, rye, oats and any hybrid varieties thereof; the amount of gliadin in the final food product shall not exceed
1 mg/100 g or 100 ml of products labelled “naturally gluten-free foodstuffs” or
b)foodstuffs which contain ingredients from wheat, rye, barley, oats, spelt or any hybrid varieties thereof; such foodstuffs shall be regarded as gluten-free if the amount of gliadin in the final food product does not exceed 5 mg/100 g or 100 ml of the product.
3.In Article 19 Paragraph 3) shall be designated as Article 19 Paragraph 1), and shall read:
“(1) Foodstuffs labelled “naturally gluten-free” may not have a gliadin content in excess of 1 mg per 100 g or 100 ml of the product”.
Existing Paragraphs 1) and 2) shall be re-numbered 2) and 3).
4.In Article 19, Paragraph 2 a) shall read:
“(2) Gluten-free foods may be labelled “without gluten” or “gluten-free” only if
a) they do not contain more than 5 mg of gliadin per 100 g or 100 ml of any product derived from cereals containing gluten, and in particular wheat, rye, triticale, barley and oats,
b) they contain starch, derived from cereals containing gluten, if the starch used did not contain more than 0,3g of proteins per 100g of the product; the plant source of the starch used is indicated on the packaging.”
6.Appendix 13 shall read:
“Appendix 13 to Decree No. 54/2004 Sb.
FOOD ADDITIVES THAT MAY BE ADDED FOR SPECIFIC PURPOSES TO FOODS FOR PARTICULAR USES
For the purposes of this table:
—‘FSMP’ means foods for particular nutritional uses intended for special medical purposes
—‘All FPNU’ means dietary foods for particular nutritional purposes, including FSMPs, but excluding infant formulae, follow-on formulae, processedcereal-based foods and baby foods intended for infants and young children.
Food additive / Conditions of UseAll FPNU / FSMP
Category 1. Vitamins
VITAMINA
—retinol / ×
—retinolacetate / ×
—retinolpalmitate / ×
—betacarotene / ×
VITAMIND
—cholecalciferol / ×
—ergocalciferol / ×
VITAMINE
—D-alphatocopherol / ×
—DL alphatocopherol / ×
—D alphatocopherol acetate / ×
—DL alphatocopherol acetate / ×
—Dalpha-tocopherol hydrogen succinate / ×
— D-alphatocopherol polyethyleneglycol 1000 succinate / ×*)
VITAMINK
—phylloquinone (phytomenadion) / ×
VITAMINB1
—thiaminhydrochloride / ×
—thiaminmononitrate / ×
VITAMINB2
—riboflavin / ×
—riboflavin5'phosphate, sodium salt / ×
NIACIN
—nicotinic acid / ×
—nicotinamide / ×
PANTOTHENIC ACID
—calcium D-pantothenate / ×
—sodium D-pantothenate / ×
—dexpanthenol / ×
VITAMINB6
—pyridoxinehydrochloride / ×
—pyridoxine5'phosphate / ×
—pyridoxinedipalmitate / ×
FOLIC ACID
—pteroylmonoglutamic acid / ×
VITAMINB12
—cyanocobalamin / ×
—hydroxocobalamin / ×
BIOTIN
—Dbiotin / ×
VITAMINC
—Lascorbic acid / ×
—sodium L-ascorbate / ×
—calcium L-ascorbate / ×
—potassium L-ascorbate / ×
—Lascorbyl6palmitate / ×
Category 2. Minerals
CALCIUM
—carbonate / ×
—chloride / ×
—salts of citric acid / ×
—gluconate / ×
—glycerophosphate / ×
—lactate / ×
—phosphate / ×
—hydroxide / ×
—oxide / ×
—sulphate / ×
—amino acids chelate / ×*)
—pyroglutamate (pidolate) / ×*)
MAGNESIUM
—acetate / ×
—carbonate / ×
—chloride / ×
—salts of citric acid / ×
—gluconate / ×
—glycerophosphate / ×
—lactate / ×
—phosphate / ×
—hydroxide / ×
—oxide / ×
—sulphate / ×
—pyroglutamate (pidolate) / ×*)
—amino acids chelate / ×*)
IRON
—ferrous carbonate / ×
—ferrous citrate / ×
—ferric ammonium citrate / ×
—ferrous gluconate / ×
—ferrous fumarate / ×
—ferric sodium diphosphate / ×
—ferrous lactate / ×
—ferrous sulphate / ×
—ferric diphosphate / ×
—ferric oxide with saccharose / ×
—elemental iron (hydrogen reduced or electrolytic) / ×
—ferrous hydroxide / ×*)
—ferrous pyroglutamate (pidolate) / ×*)
—amino acids chelate / ×*)
COPPER
—copper carbonate / ×
—copper citrate / ×
—copper gluconate / ×
—copper sulphate / ×
—copper lysine complex / ×
—amino acids chelate / ×*)
IODINE
—potassium iodide / ×
—potassium iodate / ×
—sodium iodide / ×
—sodium iodate / ×
ZINC
—acetate / ×
—chloride / ×
—citrate / ×
—gluconate / ×
—lactate / ×
—oxide / ×
—carbonate / ×
—sulphate / ×
—amino acids chelate / ×*)
MANGANESE
—carbonate / ×
—chloride / ×
—citrate / ×
—gluconate / ×
—glycerophosphate / ×
—sulphate / ×
—amino acids chelate / ×*)
SODIUM
—bicarbonate / ×
—carbonate / ×
—chloride / ×
—citrate / ×
—gluconate / ×
—lactate / ×
—hydroxide / ×
—phosphate / ×
POTASSIUM
—bicarbonate / ×
—carbonate / ×
—chloride / ×
—citrate / ×
—gluconate / ×
—glycerophosphate
—lactate / ×
—hydroxide / ×
—phosphate / ×
SELENIUM
—sodium selenate / ×
—sodium hydroselenate / ×
—sodium selenite / ×
—enriched yeast / ×*)
CHROMIUM III and their hexahydrates
—chloride / ×
—sulphate / ×
—amino acids chelate / ×*)
MOLYBDENUM VI
—ammonium molybdate / ×
—sodium molybdate / ×
FLUORINE
—potassium fluoride / ×
—sodium fluoride / ×
BORAX
—boric acid / ×*)
—sodium borate / ×*)
Category 3. Amino acids
—Lalanine / ×
—Larginine / ×
—Larginine-L-aspartate / ×
—Laspartic acid / ×
—Lcitrulline / ×
—Lcysteine / ×
—Lcysteine-N-acetate / ×
—cystine / ×
—Lhistidine / ×
—Lglutamic acid / ×
—Lglutamine / ×
—glycine / ×
—Lisoleucine / ×
—Lleucine / ×
—Llysine / ×
—Llysineacetate / ×
—LlysineL-aspartate / ×
—LlysineL-glutamate / ×
—Lmethionine / ×
—Lmethionine-acetate / ×**)
—Lornithine / ×
—Lphenylalanine / ×
—Lproline / ×
—L-serine / ×
—Lthreonine / ×
—Ltryptophan / ×
—Lthyrosine / ×
—Lvaline / ×
In the case of permitted amino acids only their sodium, potassium and calcium salts, and salts of magnesium and their hydrochlorides may be used.
Category 4. Carnitine and taurine
—Lcarnitine / ×
—Lcarnitinehydrochloride / ×
—Lcarnitine-L-tartarate / ×
—taurine / ×
Category5. Nucleotides
—adenosine5'phosphoric acid (AMP) / ×
—sodium salts of AMP / ×
—cytidine5'-monophosphoric acid (CMP) / ×
—sodium salts of CMP / ×
—guanosine5'phosphoric acid (GMP) / ×
—sodium salts of GMP / ×
—inosine5'phosphoric acid (IMP) / ×
—sodium salts of IMP / ×
—uridine5'phosphoric acid (UMP) / ×
—sodium salts of UMP / ×
Category6. Choline and inositol
—choline / ×
—cholinechloride / ×
—cholineditartrate / ×
—cholin-citrate / ×
—inositol / ×
*) The above substances may be added to foods intended for special purposes until 31 December 2006 on the understanding that the European Food Safety Authority has not adopted a negative standpoint on the use of materials for the production of foods intended for special purposes and on condition that the above substances have been used in the production of foods intended for special purposes that were marketed before 9 February 2004.
**) Only in products intended for use by persons over 1 year of age”
Article II
This Decree shall enter into force on 1 January 2005 with the exception of points 2, 3 and 4, which shall enter into force on 1 July 2007.
Rationale
I. General
The Ministry of Health submits the draft decree amending Decree No. 54/2004 Sb. on foodstuffs intended for particular uses and on their method of use as part of Act No. 110/1997 Sb., on food and tobacco products, in the wording of the most recent regulations.
The purpose of the amendment is the transposition of Commission Directive 2004/6/EC of 20 January 2004 derogating from Directive 2001/15/EC to postpone the application of the prohibition of trade to certain products. The Directive extends authorisation for the use of certain types of vitamins and mineral substances in foodstuffs intended for particular uses until 31 December 2006, provided that those foodstuffs containing the types of vitamins and mineral substances in question were already marketed before the date of the entry into force of this Directive and if the European Food Safety Authority has not given an unfavourable opinion in respect of the use of these substances in the manufacture of foods for particular nutritional uses.
A further purpose of the amendment is to rectify errors, to which the attention of the Ministry of Health has been drawn by manufacturers. This applies in particular to gluten-free foodstuffs and Table 13, which sets out the food additives that may be added for specific purposes to foods for particular uses.
The resubmission of the draft amendment to the Decree to the interdepartmental parliamentary working group is to address the issue of gluten-free foodstuffs. On 4 August 2004 and 23 September 2004 meetings took place between representatives of the Ministry of Agriculture, the State Agriculture and Food Inspectorate, the expert committee on gluten-sensitive enteropathy, the Food Research Institute, the Coeliac Association of the Czech Republic and the Czech Association for Brand Products on the theme of gliadin content in gluten-free foodstuffs. .
It is the view of the working group on gluten-sensitive enteropathy that the current norm is too high and causes health problems for coeliacs, and for this reason they are seeking a reduction from the current level of 10 mg of gliadin to 1 mg/100 g of dry material, with this norm applying to just one group – gluten-free foodstuffs – with no distinction being made between gluten-free and naturally gluten-free foodstuffs. A transition period of 2 to 3 years is proposed for manufacturers to adapt to the suggested norm.
However, with regard to the draft in theCodex Alimentarius, which provides for two groups of foodstuffs: 1) gluten-free and 2) naturally gluten-free foodstuffs and for two limits 1) 10 mg and 2) 1 mg of gliadin per 100 g of dry material, and as there is no information about anything that would lead to significant changes in this draft, and furthermore as Czech consumers are used to these two groups, the Ministry of Health of the Czech Republic has left both groups of foodstuffs in the draft decree and has also left the two limits of 5 mg and 1 mg per 100 g or 100 ml respectively. The 10 mg limit has only been reduced to 5 mg, because there is no binding legal norm in the European Union and because neighbouring states have a recommended limit within the range 1 to 10 mg. This is also because discussions in other countries are moving towards a reduction in the norm to1 mg of gliadin per 100 g of dry material. The adjustment to 100 g of the product will enable consumers to be better informed about the gliadin content of the product. A 6-moth transition period is proposed for manufacturers..
The implementation of the draft will have no economic or financial impact on the state budget, on other public budgets or economic entities, nor will it have any social or environmental effects.
The draft decree is fully compatible with the laws of the European Community, with international agreements to which the Czech Republic is bound, and is not at variance with the Constitution of the Czech Republic.
II. Specific
Article 1
To point 1
The wording of the whole note under Point 1 shall be amended, supplementing Commission Directive 2004/6/EC of 20 January 2004 derogating from Directive 2001/15/ES, to postpone the application of the prohibition of trade to certain products.
To point 2
The wording of Article 18 Paragraph 2 shall be amended to a gliadin content of 100 g or 100 ml of the product and point c), specifying the applied gliadin content per 100 ml of the product shall be deleted.
To point 3
The wording of Article 19 Paragraph 3 shall be amended to a gliadin content for foodstuffs labelled ‘naturally gluten-free’, which cannot exceed 1 mg per 100 g of the dry material of the product, in accordance with Article 18 Paragraph 2 a). Article 19 Paragraph 3 shall be renumbered Article 19 Paragraph 1 and the remaining paragraphs of Article 19 shall be renumbered.
To point 4
Above all, the wording of Article 19 Paragraph 2 a) shall be amended by deleting the calculation of the gliadin content in food via the nitrogen content. The calculation of the prolamin content by conversion via the nitrogen content shall only be possible in the case of pure starches, the origin of which is known.
To point 5
The whole of Annex 13 shall be amended in accordance with Commission Directive 2004/6/EC. The incorrect English translation of aspartic acid shall be amended to L-aspartic acid. Potassium pantothenate was listed in error. The correct version should be calcium pantothenate. Glycine has been listed under foods for special medical purposes and L-isoleucine under foods for particular nutritional uses (including FSMPs but excluding infant formulae, follow-on formulae, processed cereal-based foods and baby foods intended for infants and young children). Further amendments to the chemical names of substances and salts have been made in accordance with the draft of the Czech Health Department.
Article II
This Decree shall enter into force on 1 January 2005, with the exception of the points governing the area of gluten-free foods, which shall enter into force on 1 July 2007.