(2)(a)(ii), the added protein shall not be less than 0.48g/100 kJ (2g/100 kcal). 2.3 For biscuits mentioned in Article 1

(2)(a)(ii) and (iv), made with the addition of a high protein food, and presented as such, the added protein shall not be less than 0.36g/100 kJ (1.5g/100 kcal). 2.4 The chemical index of the added protein shall be equal to at least 80% of that of the reference protein (casein as defined in Schedule 3), or the protein efficiency ratio (PER) of the protein in the mixture shall be equal to at least 70% of that of the reference protein. In all cases, the addition of amino acids shall be permitted solely for the purpose of improving the nutritional value of the protein mixture, and only in the proportions necessary for that purpose. 3. Carbohydrates 3.1 If sucrose, fructose, glucose, glucose syrups or honey are added to products mentioned in Article 1

(2)(a)(i) and (iv): —the amount of added carbohydrates from these sources shall not exceed 1.8g/100 kJ (7.5g/100 kcal). —the amount of added fructose shall not exceed 0.9g/100 kJ (3.75g/100 kcal). 3.2 If sucrose, fructose, glucose syrups or honey are added to products mentioned in Article 1

(2)(a)(ii): —the amount of added carbohydrates from these sources shall not exceed 1.2g/100 kJ (5g/100 kcal). —the amount of added fructose shall not exceed 0.6g/100 kJ (2.5g/100 kcal). 4. Lipids 4.

(2)(a)(ii): the lipid content shall not exceed 1.1g/100 kJ (4.5g/100 kcal). If the lipid content exceeds 0.8g/100 kJ (3.3g/100 kcal): —the amount of lauric acid shall not exceed 15% of the total lipid content, —the amount of myristic acid shall not exceed 15% of the total lipid content, —the amount of linoleic acid (in the form of glycerides = linoleates) shall not be less than 70mg/100 kJ (300mg/100 kcal) and shall not exceed 285mg/100 kJ (1200mg/100 kcal). 5. Minerals 5.1 Sodium —Sodium salts may only be added to processed cereal-based foods for technological purposes, —the sodium content of processed cereal-based foods shall not exceed 25mg/100 kJ (100mg/100 kcal). 5.2. Calcium 5.2.

(2)(a) and (iv), manufactured with the addition of milk (milk biscuits) and presented as such, the amount of calcium shall not be less than 12mg/100 kJ (50mg/100 kcal). 6. Vitamins 6.1 For processed cereal-based foods, the amount of thiamin shall not be less than 25g/100 kJ (100g/100 kcal). 6.2 For products mentioned in Article 1

(2)(a)(ii): Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum Vitamin A (μg RE)

(1)14 43 60 180 Vitamin D (μg)

(2)0.25 0.75 1 3

(1)RE = all trans retinol equivalents

(2)In the form of cholecalciferol, of which 10μg = 400 i.u. of vitamin D. These limits shall be applicable if vitamins A and D are added to other processed cereal-based foods. 7. Maximum limits for vitamins, minerals and trace elements, if added The requirements concerning nutrients refer to the products ready for use, marketed as such or reconstituted as instructed by the manufacturer, except for potassium and calcium for which the requirements refer to the product as sold. Nutrient Maximum per 100 kcal Vitamin A (μg RE) Vitamin E (mg a —TE)

(1)Vitamin D (μg) Vitamin C (

1. mg)Thiamin (
2. mg)Riboflavin (
3. mg)Niacin (mg NE) Vitamin B6 (mg)

(3)Folic acid (μg) Vitamin B12 (μg) Pantothenic acid (

1. mg)Biotin (μg) Potassium (
2. mg)Calcium (
3. mg)Magnesium (
4. mg)Iron (
5. mg)Zinc (
6. mg)Copper (μg) Iodine (μg) Manganese (
7. mg)180 3 3 12.5/25

(2)0.5 0.4 4.5 0.35 50 0.35 1.5 10 160 80/180

(4)/100

(5)40 3 2 40 35 0.6

(1)α-TE = d-α-tocopherol equivalent.

(2)Limit applicable to products fortified with iron.

(3)NE = Niacin equivalents = mg nicotinic acid + mg tryptophan/60.

(4)Limit applicable to products mentioned in Article 1

(2)(a)(i) and (ii).

(5)Limit applicable to products mentioned in Article 1

(2)(a)(iv). SCHEDULE 2 ESSENTIAL COMPOSITION OF BABY FOODS FOR INFANTS AND YOUNG CHILDREN The requirements concerning nutrients refer to the products ready for use, marketed as such or reconstituted as instructed by the manufacturer.

1. Protein 1.1 If meat, poultry, fish, offal or other traditional source of protein, are the only ingredients mentioned in the name of the product, then: —the named meat, poultry, fish, offal or other traditional protein source, in total, shall constitute not less than 40% by weight of the total product, —each named meat, poultry, fish, offal or other traditional source of protein shall constitute not less than 25%, by weight, of total named protein sources, —the total protein from the named sources shall not be less than 1.7g/100 kJ (7g/100 kcal). 1.2 If meat, poultry, fish, offal or other traditional source of protein, singularly or in combination, are mentioned first in the name of the product, whether or not the product is presented as a meal, then: —the named meat, poultry, fish, offal or other traditional protein source, in total, shall constitute not less than 10% by weight of the total product, —each named meat, poultry, fish, offal or other traditional source of protein shall constitute not less than 25% by weight, of total named protein sources, —the protein from the named sources shall not be less than 1g/100 kJ (4g /100 kcal). 1.3 If meat, poultry, fish, offal or other traditional source of protein singularly or in combination are mentioned, but not first, in the name of the product, whether or not the product is presented as a meal, then: —the named meat, poultry, fish, offal or other traditional protein source, in total, shall constitute not less than 8% by weight of the total product, —each named meat, poultry, fish, offal or other traditional source of protein shall constitute not less than 25%, by weight, of total named protein sources, —the protein from the named sources shall not be less than 0.5g/100 kJ (2.2g/100 kcal), —the total protein in the product from all sources shall not be less than 0.7g/100 kJ (3g/100 kcal). 1.4 If cheese is mentioned together with other ingredients in the name of a savoury product, whether or not the product is presented as a meal, then: —the protein from the dairy sources shall not be less than 0.5g/100kJ (2.2g/100 kcal) —the total protein in the product from all sources shall not be less than 0.7g/100kJ (3g/100 kcal) 1.5 If the product is designated on the label as a meal, but does not mention meat, poultry, fish, offal or other traditional source of protein in the name of the product, the total protein in the product from all sources shall not be less than 0.7g/100 kJ (3g/100 kcal). 1.6 Sauces presented as an accompaniment to a meal shall be exempt from the requirements of points 1.1 to 1.5 inclusive. 1.7 Sweet dishes that mention dairy products as the first or only ingredient in the name shall contain not less than 2.2g dairy protein/100 kcal. All other sweet dishes shall be exempt from the requirements in 1.1 to 1.
2. 1.8 The addition of amino acids shall be permitted solely for the purpose of improving the nutritional value of the protein present, and only in the proportions necessary for that purpose.
3. Carbohydrates The quantities of total carbohydrates present in fruit and vegetable juices and nectars, fruit-only dishes, and desserts or puddings shall not exceed: —10g/100ml for vegetable juices and drinks based on them, —15g/100ml for fruit juices and nectars and drinks based on them, —20g/100g for fruit-only dishes, —25g/100g for desserts and puddings, —5g/100g for other non-milk-based drinks.
4. Fat 3.1 For products referred to in point 1.1: if meat or cheese are the only ingredients or are mentioned first in the name of a product, the total fat in the product from all sources shall not exceed 1.4g/100 kJ (6g/100 kcal). 3.2 For all other products, the total fat in the product from all sources shall not exceed 1.1g/100 kJ (4.5g/100 kcal).
5. Sodium 4.1 The final sodium content in the product shall be either not more than 48mg/100 kJ (200mg/100 kcal) or not more than 200mg per 100g. However, if cheese is the only ingredient mentioned in the name of the product, the final sodium content in the product shall not be more than 70mg/100 kJ (300mg/100 kcal). 4.2 Sodium salts may not be added to products based on fruit, nor to desserts, puddings except for technological purposes.
6. Vitamins Vitamin C In a fruit juice, nectar, or vegetable juice the final content of vitamin C in the product shall be either not less than 6mg/100 kJ (25mg/100 kcal) or not less than 25mg per 100g. Vitamin A In vegetable juices, the final content of vitamin A in the product shall be not less than 25μg RE/100 kJ (100μg RE/100 kcal). Vitamin A shall not be added to other baby foods. Vitamin D Vitamin D shall not be added to baby foods.
7. Maximum limits for vitamins, minerals and trace elements, if added The requirements concerning nutrients refer to the products ready for use, marketed as such or reconstituted as instructed by the manufacturer, except for potassium and calcium for which the requirements refer to the product as sold. Nutrient Maximum per 100 kcal Vitamin A (μg RE) Vitamin E (mg a —TE) Vitamin C (mg) Thiamin (mg) Riboflavin (mg) Niacin (mg NE) Vitamin B6 (mg) Folic acid (μg) Vitamin B12 (μg) Pantothenic acid (mg) Biotin (μg) Potassium (mg) Calcium (mg) Magnesium (mg) Iron (mg) Zinc (mg) Copper (μg) Iodine (μg) Manganese (mg) 180

(1)3 12.5/25

(2)/125

(3)0.25 0.4 4.5 0.35 50 0.35 1.5 10 160 80 40 3 2 40 35 0.6

(1)In accordance with the provisions of point 5.

(2)Limit applicable to products fortified with iron.

(3)Limit applicable to fruit-based dishes, fruit juices, nectars and vegetable juices. SCHEDULE 3 AMINO ACID COMPOSITION OF CASEIN (

1. g)per 100 g of protein) Arginine 3.7 Cystine 0.3 Histidine 2.9 Isoleucine 5.4 Leucine 9.5 Lysine 8.1 Methionine 2.8 Phenylalanine 5.2 Threonine 4.7 Tryptophan 1.6 Tyrosine 5.8 Valine 6.7 SCHEDULE 4 NUTRITIONAL SUBSTANCES 1. Vitamins Vitamin A Retinol Retinyl acetate Retinyl palmitate beta carotene Vitamin D Vitamin D2 (= ergocalciferol) Vitamin D3 (= cholecalciferol) Vitamin B1 Thiamin hydrochloride Thiamin mononitrate Vitamin B2 Riboflavin Riboflavin-5’-phosphate, sodium Niacin Nicotinamide Nicotinic acid Vitamin B6 Pyridoxine hydrochloride Pyridoxine-5-phosphate Pyridoxine dipalmitate Pantothenic Acid D-pantothenate, calcium D-pantothenate, sodium Dexpanthenol Folate Folic acid Vitamin B12 Cyanocobalamin Hydroxocobalamin Biotin D-biotin Vitamin C L-Ascorbic acid Sodium L-ascorbate Calcium L-ascorbate 6-Palmityl-L-ascorbic acid (ascorbyl palmitate) potassium ascorbate Vitamin K Phylloquinone (Phytomenadione) Vitamin E D-alpha tocopherol DL-alpha tocopherol D-alpha tocopherol acetate DL-alpha tocopherol acetate 2. Amino acids L-arginine) L-cystine) L-histidine) L-isoleucine) and their hydrochlorides L-leucine) L-lysine) L-cysteine) L-methionine L-phenylalanine L-threonine L-tryptophan L-tyrosine L-valine 3. Others Choline Choline chloride Choline citrate Choline bitartrate Inositol L-Carnitine L-carnitine hydrochloride 4. Salts of minerals and trace elements Calcium Calcium carbonate Calcium chloride Calcium salts of citric acid Calcium gluconate Calcium glycerophosphate Calcium lactate Calcium oxide Calcium hydroxide Calcium salts of orthophosphoric acid Magnesium Magnesium carbonate Magnesium chloride Magnesium salts of citric acid Magnesium gluconate Magnesium oxide Magnesium hydroxide Magnesium salts of orthophosphoric acid Magnesium sulphate Magnesium lactate Magnesium glycerophosphate Potassium Potassium chloride Potassium salts of citric acid Potassium gluconate Potassium lactate Potassium glycerophosphate Iron Ferrous citrate Ferric ammonium citrate Ferrous gluconate Ferrous lactate Ferrous sulphate Ferrous fumarate Ferric diphosphate (Ferric pyrophosphate) Elemental iron (carbonyl + electrolytic + hydrogen-reduced) Ferric saccharate Sodium ferric diphosphate Ferrous carbonate Copper Copper-lysine complex Cupric carbonate Cupric citrate Cupric gluconate Cupric sulphate Zinc Zinc acetate Zinc chloride Zinc citrate Zinc lactate Zinc sulphate Zinc oxide Zinc gluconate Manganese Manganese carbonate Manganese chloride Manganese citrate Manganese gluconate Manganese sulphate Manganese glycerophosphate Iodine Sodium iodide Potassium iodide Potassium iodate Sodium iodate SCHEDULE 5 REFERENCE VALUES FOR NUTRITION LABELLING FOR FOODS INTENDED FOR INFANTS AND YOUNG CHILDREN Nutrient Labelling Reference Value Vitamin A Vitamin D Vitamin C Thiamin Riboflavin Niacin equivalents Vitamin B6 Folate Vitamin B12 Calcium Iron Zinc Iodine Selenium Copper (μg) 400 (μg) 10 (
2. mg)25 (
3. mg)0.5 (
4. mg)0.8 (
5. mg)9 (
6. mg)0.7 (μg) 100 (μg) 0.7 (
7. mg)400 (
8. mg)6 (
9. mg)4 (μg) 70 (μg) 10 (
10. mg)0.4 SCHEDULE 6 SPECIFIC MAXIMUM RESIDUE LEVELS OF PESTICIDES OR METABOLITES OF PESTICIDES IN PROCESSED CEREAL-BASED FOODS AND BABY FOODS Chemical name of the substance Maximum residuelevel (mg/
11. kg)Cadusafos 0.006 Demeton-S-methyl/demeton-S-methyl sulfone/oxydemeton-methyl (individually or combined, expressed as demeton-S-methyl) 0.006 Ethoprophos 0.008 Fipronil (sum of fipronil and fipronil-desulfinyl, expressed as fipronil) 0.004 Propineb/propylenethiourea (sum of propineb and propylenethiourea) 0.006 SCHEDULE 7 PESTICIDES WHICH SHALL NOT BE USED IN AGRICULTURAL PRODUCTION INTENDED FOR THE PRODUCTION OF PROCESSED CEREAL-BASED FOODS AND BABY FOODS Table 1 Chemical name of the substance (residue definition) Disulfoton (sum of disulfoton, disulfoton sulfoxide and disulfoton sulfone expressed as disulfoton) Fensulfothion (sum of fensulfothion, its oxygen analogue and their sulfones, expressed as fensulfothion) Fentin, expressed as triphenyltin cation Haloxyfop (sum of haloxyfop, its salts and esters including conjugates, expressed as haloxyfop) Heptachlor and trans-heptachlor epoxide, expressed as heptachlor Hexachlorobenzene Nitrofen Omethoate Terbufos (sum of terbufos, its sulfoxide and sulfone, expressed as terbufos) Table 2 Chemical name of the substance Aldrin and dieldrin, expressed as dieldrin Endrin SCHEDULE 8 Form of offical certificate to be given by an approved examiner to an authorised officer. EUROPEAN COMMUNITIES (PROCESSED CEREAL-BASED FOODS AND BABY FOODS FOR INFANTS AND YOUNG CHILDREN) REGULATIONS 2007 Certificate of Analysis To

(1).............................. I, the undersigned

(2)................................................ being an approved examiner for the purpose of the above Regulations certify that on the ................................ day of .................................. 20........ a sample marked

(3)......................................... Date ................................................ Number .................................................... Weight or Measure ...................................... was submitted to me by you and I certify that the sample was prepared and analysed/examined by me or under my direction

(4)and as a result I am of the opinion that

(5)Observations:

(6)I further certify that the sample has undergone no change which would affect my opinion/observations expressed above. Certified by me this ................................. day of ......................................... 20 .......... at

(7)................................................ Name in BLOCK LETTERS ....................................................... Status ............................................................... Signature ............................................................. Official Stamp NOTES

(1)Insert the name and address of the person submitting the sample for analysis.

(2)Insert description (e.g. Executive Analytical Chemist located at a Public Analyst Laboratory).

(3)Insert particulars of marking (e.g. name, date etc.) and the weight or measure (this may be left unanswered if the sample cannot be conveniently weighed or measured or if the weight or measurement is not material to the result of analysis).

(4)Indicate whether the approved examiner carried out the analysis himself or herself or whether it was carried out by another under the direction of the approved examiner.

(5)Here the approved examiner should specify the result of the analysis having regard to the provisions of the relevant legislation.

(6)Here the approved examiner may insert, at his or her discretion, his or her opinion whether the analysis indicates any addition, abstraction, deficiency or the presence of foreign matter or other defect and whether the composition or quality is thereby affected; any physical, chemical or other properties bearing on the composition or quality of the article; whether the article is injurious to health or unfit for human consumption; whether and in what respect a label and description relating to the sample is incorrect or misleading; and he or she may add any other observations as he or she may consider relevant.

(7)Insert the name and address of the laboratory carrying out the analysis/examination. GIVEN under my Official Seal, 28 November 2007 MARY HARNEY, Minister for Health and Children. EXPLANATORY NOTE (This note is not part of the instrument and does not purport to be a legal Interpretation.) These Regulations give effect to Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children. These Regulations revoke the European Communities (Processed Cereal-Based Foods and Baby Foods for Infants and Young Children) Regulations 2004 ( S.I. No. 433 of 2004 ). These Regulations may be cited as the European Communities (Processed Cereal-Based Foods and Baby Foods for Infants and Young Children) Regulations

1. 1 OJ L 339, 6.12.2006, p.
2. 2 OJ L 31, 1.2.2002, p.
3. 3 OJ L 165, 30.4.2004, p. 1, as affected by the Corrigendum to Regulation (EC) No. 882/2004, OJ L 191, 28.5.2004, p.
4. 4 OJ L 230, 19.8.1991, p.
5. 5 OJ L 109, 6.5.2000, p.
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