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Regulation 3
1. The substances listed in column 1 of Table 1 must be added to flour derived from common wheat in the proportions and in accordance with the other provisions specified in column 2.
Column 1 Substance | Column 2 Quantity of the substance to be added and other provisions in relation to addition of those substances |
---|---|
Calcium carbonate; | (a) At least 300 mg/100 g flour. |
(b) Not more than 455 mg/100 g flour. | |
(c) The substance must be added in the form of E 170 calcium carbonate conforming to the specification set out in Schedule 2 to these Regulations. | |
(d) But the addition of calcium carbonate is not required to flour that is— | |
(i) self-raising flour with a calcium content of 0.2% or more, or | |
(ii) wheat malt flour. | |
Folic acid | (a) 0.25 mg/100 g flour. |
(b) The substance must be added in the form of pteroylmonoglutamic acid conforming to the criteria in the monograph for folic acid hydrate contained in the British Pharmacopoeia 2023 at page I-1110. |
2.—(1) The substances listed in column 1 of Table 2 must be present in flour derived from common wheat in the proportions specified in column 2.
(2) Where the addition of substances is necessary in order to meet the required proportions specified in column 2 of Table 2, the substances must be added in accordance with the other provisions specified that column.
Column 1 Substance | Column 2 Quantity of the substance that must be present in flour and other provisions in relation to addition of those substances |
---|---|
Iron | (a) At least 2.10 mg/100 g flour. |
(b) Any addition of the substance must be in the form of any of, or any combination of, the following— | |
(i) ferric ammonium citrate conforming to the criteria in the monograph for ferric ammonium citrate contained in the British Pharmacopoeia 1973 at page 201; | |
(ii) ferrous sulphate conforming to the criteria in the monograph for ferrous sulphate heptahydrate contained in the British Pharmacopoeia 2023 at page I-1037; | |
(iii) dried ferrous sulphate conforming to the criteria in the monograph for dried ferrous sulphate contained in the British Pharmacopoeia 2023 at page I-1036; | |
(iv) iron powder conforming to the specification contained in Schedule 3 to these Regulations. | |
>Niacin | (a) At least 2.40 mg/100 g flour. |
(b) Any addition of the substance must be in the form of either, or a combination of, the following— | |
(i) nicotinic acid conforming to the criteria in the monograph for nicotinic acid contained in the British Pharmacopoeia 2023 at page II-404; | |
(ii) nicotinamide conforming to the criteria in the monograph for nicotinamide contained in the British Pharmacopoeia 2023 at page II-399. | |
Thiamin (vitamin B 1) | (a) At least 0.24 mg/100 g flour. |
(b) Any addition of the substance must be in the form of thiamin hydrochloride conforming to the criteria in the monograph for thiamin hydrochloride contained in the British Pharmacopoeia 2023 at page II-1129. |
Regulation 3 and Schedule 1
(1) European Inventory of Existing Commercial Chemical Substances, as published in OJ No C 146A, 15.6.1990, p.1. | |
(2) Sum of ethylene oxide and 2-chloroethanol expressed as ethylene oxide (i.e. ethylene oxide + (0.55 × 2-chloroethanol)). | |
Synonyms | CI Pigment White 18; Chalk |
Definition | Calcium carbonate is the product obtained from ground limestone or by the precipitation of calcium ions with carbonate ions. |
Colour Index No | 77220 |
EINECS number(1) | Calcium carbonate: 207-439-9 Limestone: 215-279-6 |
Chemical name | Calcium carbonate |
Chemical formula | CaCO3 |
Molecular weight | 100.1 g/mol |
Assay | Content ≥ 98% on the anhydrous basis |
Description | White crystalline or amorphous, odourless and tasteless powder |
Identification | |
---|---|
Solubility | Practically insoluble in water and in alcohol. Dissolves with effervescence in diluted acetic acid, in diluted hydrochloric acid and in diluted nitric acid, and the resulting solutions, after boiling, give positive tests for calcium. |
Purity | |
Loss on drying | ≤ 2.0% (200°C, 4 hours) |
Acid-insoluble substances | ≤ 0.2% |
Magnesium and alkali salt | ≤ 1.0% |
Fluoride | ≤ 50 mg/kg |
Antimony (Sb) | ≤ 100mg/kg, singly or in combination |
Copper (Cu) | |
Chromium (Cr) | |
Zinc (Zn) | |
Barium (Ba) | |
Arsenic (As) | ≤ 3 mg/kg |
Lead (Pb) | ≤ 3 mg/kg |
Cadmium (Cd) | ≤ 3 mg/kg |
Ethylene oxide(2) | Total residues of ethylene oxide, irrespective of origin, must not exceed 0.1 mg/kg |
Regulation 3 and Schedule 1
(1) BS 410:1969 “Specification for test sieves”. Published by the British Standards Institution on 31 August 1971. Available at: https://knowledge.bsigroup.com. | |
Definition | Iron powder consisting essentially of finely-divided metallic iron containing at least 90% by weight of iron and conforming to the requirements of this Schedule. |
Chemical name | Iron |
Chemical formula | Fe |
Assay | Accurately weigh 0.25 g of sample into a stoppered flask. Add a hot solution of 1.25 g of copper sulphate pentahydrate in 20 ml of water and shake for 10 minutes. Filter rapidly and wash the filter with water; acidify the mixed filtrate and washings with sulphuric acid, and titrate with N/10 potassium permanganate. Each ml of N/10 potassium permanganate is equivalent to 0.005585 g of iron. |
Description | Fine greyish-black powder of such granularity that not more than 0.1% by weight remains on a British Standard 410:1969 (1) wire sieve nominal aperture size 150 μm and not more than 5% by weight on a British Standard 410:1969 wire sieve nominal aperture size 53 μm. |
Identification | |
---|---|
Solubility | At least 95% of the iron content when determined by the following method. Accurately weigh 0.1 g of sample into a 750 ml conical flask. Add 450 ml 0.2% weight in weight hydrochloric acid previously warmed to 37°C. Stir continuously for 3 hours, maintaining the temperature at 37°C. Cool to room temperature and dilute to 500 ml with distilled water. Filter; determine the iron content of the filtrate by a suitable method. Calculate the total iron in solution as a percentage of the metallic iron content of the sample taken. |
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