LegalizeS.I. No. 852/2007 - European Communities (Infant formulae and Follow-on formulae) Regulations 2007
This is the act as published. Later amendments are not folded into the text below: each one is a separate act in this repository and an entry in this law's history.
5 amending acts · 2019-08-16, S.I. No. 425/2019 - European Union (Food Intended For Infants And Young Children, Food Fo…
| Mineral substances | Permitted salts |
| Calcium (Ca) | Calcium carbonate Calcium chloride Calcium salts of citric acid Calcium gluconate Calcium glycerophosphate Calcium lactate Calcium salts of orthophosphoric acid Calcium hydroxide |
| Magnesium (Mg) | Magnesium carbonate Magnesium chloride Magnesium oxide Magnesium salts of orthophosphoric acid Magnesium sulphate Magnesium gluconate Magnesium hydroxide Magnesium salts of citric acid |
| Iron (Fe) | Ferrous citrate Ferrous gluconate Ferrous lactate Ferrous sulphate Ferric ammonium citrate Ferrous fumarate Ferric diphosphate (Ferric pyrophosphate) Ferrous bisglycinate |
| Copper (Cu) | Cupric citrate Cupric gluconate Cupric sulphate Copper-lysine complex Cupric carbonate |
| Iodine (I) | Potassium iodide Sodium iodide Potassium iodate |
| Zinc (Zn) | Zinc acetate Zinc chloride Zinc lactate Zinc sulphate Zinc citrate Zinc gluconate Zinc oxide |
| Manganese (Mn) | Manganese carbonate Manganese chloride Manganese citrate Manganese sulphate Manganese gluconate |
| Sodium (Na) | Sodium bicarbonate Sodium chloride Sodium citrate Sodium gluconate Sodium carbonate Sodium lactate Sodium salts of orthophosphoric acid Sodium hydroxide |
| Potassium (K) | Potassium bicarbonate Potassium carbonate Potassium chloride Potassium salts of citric acid Potassium gluconate Potassium lactate Potassium salts of orthophosphoric acid Potassium hydroxide |
| Selenium (Se) | Sodium selenate Sodium selenite |
3. Amino acids and other nitrogen compounds
L-cystine and its hydrochloride
L-histidine and its hydrochloride
L-isoleucine and its hydrochloride
L-leucine and its hydrochloride
L-lysine and its hydrochloride
L-cysteine and its hydrochloride
L-methionine
L-phenylalanine
L-threonine
L-tryptophan
L-tyrosine
L-valine
L-carnitine and its hydrochloride
L-carnitine-L-tartrate
Taurine
Cytidine 5’-monophosphate and its sodium salt
Uridine 5’-monophosphate and its sodium salt
Adenosine 5’-monophosphate and its sodium salt
Guanosine 5’-monophosphate and its sodium salt
Inosine 5’-monophosphate and its sodium salt
4. Other nutritional substances
Choline
Choline chloride
Choline citrate
Choline bitartrate
Inositol
SCHEDULE 4 NUTRITION AND HEALTH CLAIMS FOR INFANT FORMULAE AND CONDITIONS WARRANTING A CORRESPONDING CLAIM
1. Nutrition Claims
| Nutrition claim related to | Conditions warranting the nutrition claim |
| 1.1 Lactose only | Lactose is the only carbohydrate present. |
| 1.2 Lactose free | Lactose content is not greater than 2.5mg/100 kJ (10mg/100 kcal). |
| 1.3 Added LCP or an equivalent nutrition claim related to the addition of docosahexaenoic acid | The docosahexaenoic acid content is not less than 0.2% of the total fatty acid content. |
| 1.4 Nutrition claims on the addition of the following optional ingredients: | |
| 1.4.1 taurine | ) |
| ) | |
| 1.4.2 fructo-oligosaccharides and galacto- oligosaccharides | ) Voluntarily added at a level that would be ) appropriate for the intended particular use ) by infants and in accordance with the ) conditions set out in Schedule 1. |
| 1.4.3 nucleotides | ) |
2. Health Claims (Including Reduction of Disease Risk Claims)
| Nutrition claim related to | Conditions warranting the health claim |
| 2.1 Reduction of risk to allergy to milk proteins. This health claim may include terms referring to reduced allergen or reduced antigen properties. | (a) Objective and scientifically verified data as proof to the claimed properties must be available; |
| (b) The infant formulae shall satisfy the provisions set out in point 2.2 of Schedule 1 and the amount of immunoreactive protein measured with methods generally acceptable as appropriate shall be less than 1% of nitrogen containing substances in the formulae; | |
| (c) The label shall indicate that the product must not be consumed by infants allergic to the intact proteins from which it is manufactured unless generally accepted clinical tests provide proof of the infant formulae’s tolerance in more than 90% of infants (confidence interval 95%) hypersensitive to proteins from which the hydrolysate is manufactured; | |
| (d) The infant formulae administered orally must not induce sensitisation, in animals, to the intact proteins from which the infant formulae are manufactured. |
SCHEDULE 5 INDISPENSABLE AND CONDITIONALLY INDISPENSABLE AMINO ACIDS IN BREAST MILK
For the purpose of these Regulations, the indispensable and conditionally indispensable amino acids in breast milk, expressed in mg per 100 kJ and 100 kcal, are the following:
| Per 100 kJ ( 1) | Per 100 kcal | |
| CystineHistidineIsoleucineLeucineLysineMethioninePhenylalanineThreonineTryptophanTyrosineValine | 9 10 22 40 27 5 20 18 8 18 21 | 38 40 90 166 113 23 83 77 32 76 88 |
| (1) 1 kJ = 0.239 kcal. |
SCHEDULE 6 SPECIFICATION FOR THE PROTEIN CONTENT AND SOURCE AND THE PROCESSING OF PROTEIN USED IN THE MANUFACTURE OF INFANT FORMULAE WITH A PROTEIN CONTENT LESS THAN 0.56g/100 kJ (2.25g/100 kcal) MANUFACTURED FROM HYDROLYSATES OF WHEY PROTEINS DERIVED FROM COWS’ MILK PROTEIN
1. Protein content
Protein content = nitrogen content x 6.25
Minimum 0.44g/100 kJ (1.86g/100 kcal)
Maximum 0.7g/100 kJ (3g/100 kcal)
2. Protein source
Demineralised sweet whey protein derived from cows’ milk after enzymatic precipitation of caseins using chymosin, consisting of:
- (a) 63% caseino-glycomacropeptide free whey protein isolate with a minimum protein content of 95% of dry matter and protein denaturation of less than 70% and a maximum ash content of 3%; and
- (b) 37% sweet whey protein concentrate with a minimum protein content of 87% of dry matter and protein denaturation of less than 70% and a maximum ash content of 3.5%.
3. Protein processing
Two-stage hydrolysis process using a trypsin preparation with a heat-treatment step (from 3 to 10 minutes at 80 to 100 °C) between the two hydrolysis steps.
SCHEDULE 7 REFERENCE VALUES FOR NUTRITION LABELLING FOR FOODS INTENDED FOR INFANTS AND YOUNG CHILDREN
| Nutrient | Labelling reference value |
| Vitamin A Vitamin D Vitamin E Vitamin K Vitamin C Thiamin Riboflavin Niacin Vitamin B6 Folate Vitamin B12 Pantothenic acid Biotin Calcium Phosphorus Potassium Sodium Chloride Iron Zinc Iodine Selenium Copper Magnesium Manganese | (μg) 400 (μg) 7 (mg TE) 5 (μg) 12 (mg) 45 (mg) 0.5 (mg) 0.7 (mg) 7(mg) 0.7 (μg) 125 (μg) 0.8 (mg) 3 (μg) 10 (mg) 550 (mg) 550 (mg) 1000 (mg) 400 (mg) 500 (mg) 8 (mg) 5 (μg) 80 (μg) 20 (mg) 0.5 (mg) 80 (mg) 1.2 |
SCHEDULE 8 PESTICIDES WHICH SHALL NOT BE USED IN AGRICULTURAL PRODUCTION INTENDED FOR THE PRODUCTION OF INFANT FORMULAE AND FOLLOW–ON FORMULAE
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 9 SPECIFIC MAXIMUM RESIDUE LEVELS OF PESTICIDES OR METABOLITES OF PESTICIDES IN INFANT FORMULAE AND FOLLOW-ON FORMULAE
| Chemical name of the substance | Maximum residue level (mg/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 10 Form of official certificate to be given by an approved examiner to an authorised officer.
European Communities
(Infant Formulae and Follow-On Formulae) 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’s 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,
21 December 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 2006/141/EC of 22 December 2006 on compositional, labelling, marketing and informational requirements for infant formulae and follow-on formulae intended for infants and young children, and give further effect to Council Directive 92/52/EEC on infant formulae and follow-on formulae intended for export to third countries. These Regulations do not give effect to those aspects of Commission Directive 2006/141/EC that amend Directive 1999/21/EC.
In order to provide for the transitional arrangements under Commission Directive 2006/141/EC, certain provisions of the European Communities (Infant Formulae and Follow-on Formulae) Regulations 2004 ( S.I. No. 242 of 2004 ) are revoked, while the remainder will remain in effect until 31 December 2009.
These Regulations revoke the European Communities (Infant Formulae and Follow-on Formulae) (Amendment) Regulations 2007 ( S.I. No. 242 of 2007 ).
These Regulations may be cited as the European Communities (Infant Formulae and Follow-On Formulae) Regulations 2007.
Footnotes
OJ L 401, 30.12.2006, p. 1.
OJ L 91, 7.4.1999, p. 29.
OJ L 179, 1.7.1992, p. 129.
OJ L 404, 30.12.2006, p. 9, as affected by Corrigendum to Regulation (EC) No. 1924/2006, OJ L 12, 18.1.2007, p. 3.
OJ L 31, 1.2.2002, p. 1.
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. 1.
OJ L 230, 19.8.1991, p. 1.
OJ L 109, 6.5.2000, p. 29.
OJ L 186, 30.6.1989, p. 21, as amended.
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