S.L. 449.29 Art. 7in products infants shall for one or product. Values for Vitamins: Vitamin A Vitamin D Vitamin K Vitamin C Thiamin Riboflavin Vitamin B6 Niacin (mg Folic acid Vitamin Pantothenic Biotin (µg) Vitamin TE) Minerals: Sodium Chloride Potassium Calcium Phosphorus Magnesium Iron (mg) Zinc (mg) Copper (µg)

Maximum levels of vitamins and mineral substances present referred to in regulation 3.2(c) other than those intended specifically for not exceed those specified in Table 2, without prejudice to modifications more of these nutrients rendered necessary by the intended use of the TABLE 1

vitamins, mineral and trace elements in nutritionally complete foods intended for use by infants

Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum (µg RE) 14 43 60 180

(µg) 0.25 0.75 1 3

(µg) 1 5 4 20

(mg) 1.9 6 8 25

(mg) 0.01 0.075 0.04 0.3

(mg) 0.014 0.1 0.06 0.45

(mg) 0.009 0.075 0.035 0.3 NE) 0.2 0.75 0.8 3

(µg) 1 6 4 25 B12 (µg) 0.025 0.12 0.1 0.5 acid (mg) 0.07 0.5 0.3 2 0.4 5 1.5 20  E (mg - 0.5/g 0.75 0.5/g 3 polyunsatura- polyunsatura-ted fatty ted fatty acids acids expressed as expressed as linoleic acid linoleic acid but in no case but in no case less than 0.1 less than 0.1 mg per 100 mg per 100 available kJ available kcal

Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum

(mg) 5 14 20 60

(mg) 12 29 50 125

(mg) 15 35 60 145

(mg) 12 60 50 250 (mg)1 6 22 25 90

(mg) 1.2 3.6 5 15 0.12 0.5 0.5 2 0.12 0.6 0.5 2.4 4.8 29 20 120 1.2 8.4 5 35

(µg) 0.25 0.7 1 3 Minerals: Per 100 kJ Per 100 Minimum Maximum Minimum Manganese (mg) 0.012 0.05 0.05 Chromium (µg) - 2.5 -Molybdenum (µg) - 2.5 -Fluoride (mg) - 0.05 -

1 The calcium/phosphorus ratio shall not be less than 1.2 nor greater than 2.0.

TABLE 2

Values for vitamins, minerals and trace elements in nutritionally complete other than those intended for use by infants

Vitamins: Per 100 kJ Per 100 Minimum Maximum Minimum Vitamin A (µg RE) 8.4 43 35 Vitamin D (µg) 0.12 0.65/0.752 0.5 Vitamin K (µg) 0.85 5 3.5 Vitamin C (mg) 0.54 5.25 2.25 Thiamin (mg) 0.015 0.12 0.06 Riboflavin (mg) 0.02 0.12 0.08 Vitamin B6 (mg) 0.02 0.12 0.08 Niacin (mg NE) 0.22 0.75 0.9 Folic acid (µg) 2.5 12.5 10 Vitamin B12 (µg) 0.017 0.17 0.07 Pantothenic acid (mg) 0.035 0.35 0.15 Biotin (µg) 0.18 1.8 0.75  Vitamin E (mg - 0.5/g 0.75 0.5/g TE) polyunsatura- polyunsatura-ted fatty ted fatty acids acids expressed as expressed as linoleic acid linoleic acid but in no case but in no case less than 0.1 less than 0.1 mg per 100 mg per 100 available kJ available kcal

2 For products intended for children of 1 to 10 years of age.

Per 100 kJ Per 100 kcal Minimum Maximum Minimum Maximum

(mg) 7.2 42 30 175

(mg) 7.2 42 30 175

(mg) 19 70 80 295

(mg) 8.4/122 42/602 35/502 175/2502 (mg)3 7.2 19 30 80

(mg) 1.8 6 7.5 25 0.12 0.5 0.5 2 0.12 0.36 0.5 1.5 15 125 60 500 1.55 8.4 6.5 35

(µg) 0.6 2.5 2.5 10

(mg) 0.012 0.12 0.05 0.5

(µg) 0.3 3.6 1.25 15 Molybdenum (µg) 0.72 4.3 3.5 18

(mg) - 0.05 - 0.2

calcium/phosphorus ratio shall not be less than 1.2 nor greater than 2.0.

SECOND SCHEDULE

under which dietary foods for special medical purposes are sold, in all the European Community languages: Bulgarian:

храни за специални медицински цели"

dietético para usos médicos especiales"

potravina určená pro zvláštní lékařské účely"

"Levnedsmiddel/Levnedsmidler til særlige medicinske formål"

"Diätetisches/Diätetische Lebensmittel für besondere medizinische Zwecke Diäten)" - in Estonian:

"Toit meditsiinilisel näidustusel kasutamiseks" - in Greek: "Διαιτητικά τρόφιμα για ειδικούς ιατρικούς σκοπούς"

- in English: "Food(s) for special medical purposes" - in French:

"Aliment(s) diététique(s) destiné(s) a des fins médicales spéciales" - in Croatian: "Hrana za posebne medicinske potrebe"

- in Italian: "Alimento dietetico destinato a fini medici speciali" - in Latvian:

"Diētiskā pārtika cilvēkiem ar veselības traucējumiem" - in Lithuanian: "Specialios medicininės paskirties maisto produktai"

- in Hungarian: "Speciális – gyógyászati célra szánt – tápszer" - in Maltese:

"Ikel dijetetiku għal skopijiet mediċi speċifiċi" - in Dutch: "Dieetvoeding voor medisch gebruik"

- in Polish: "Dietetyczne środki spożywcze specjalnego przeznaczenia medycznego" - in Portuguese:

"Produto dietético de uso clínico" - in Romanian: "Alimente dietetice pentru scopuri medicale speciale"

- in Slovak: "dietetická potravina na osobitné lekárske účely" - in Slovenian:

"Dietno (dietetično) živilo za posebne zdravstvene namene" - in Finnish: "Kliininen ravintovalmiste/kliinisiä ravintovalmisteita"

- in Swedish: "Livsmedel för speciella medicinska ändamål".