S.I. No. 433/2004 - European Communities (Processed Cereal-Based Foods and Baby Foods For Infants and Young Children) Regulations 2004

I, Micheál Martin, Minister for Health and Children, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972), having regard to Council Directive 89/398/EEC¹ of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses, as amended by Directive 96/84/EC² of the European Parliament and of the Council of 19 December 1996, and Directive 1999/41/EC³ of the European Parliament and of the Council of 7 June 1999, and having regard to Commission Directive 2001/15/EC⁴ of 15 February 2001 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses, and for the purpose of giving effect to Commission Directive 96/5/EC,⁵ Euratom of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children, as amended by Commission Directive 98/36/EC⁶ of 2 June 1998, and Commission Directive 1999/39/EC⁷ of 6 May 1999, and Commission Directive 2003/13/EC⁸ of 10 February 2003, hereby make the following regulations:

PART 1 Preliminary

1.

• (2) The requirements of paragraphs (10) and (11) of Regulation 4 shall come into effect on 6 March 2005.

• (3) From the date of coming into effect of these Regulations, a person may trade in products complying with the provisions referred to in paragraph (2).

2.

“Act of 1998” means the Food Safety Authority of Ireland Act 1998 (No. 29 of 1998);

“approved examiner” in these Regulations means -

• (a) a Public Analyst located at a Public Analyst’s Laboratory,

• (b) a Deputy Public Analyst located at a Public Analyst’s Laboratory,

• (c) an Executive Analytical Chemist located at a Public Analyst’s Laboratory,

• (d) a Consultant Microbiologist located at an Official Laboratory,

• (e) a Chief Laboratory Technologist located at an Official Laboratory, or

• (f) a person designated by the Minister pursuant to Regulation 16;

“authorised officer” means an authorised officer appointed under section 49 of the Act of 1998;

“Authority” means the Food Safety Authority of Ireland, established under section 9 of the Act of 1998;

“baby foods” means foodstuffs, other than processed cereal-based foods, for particular nutritional use fulfilling the particular requirements of infants and young children in good health and intended for use by infants while they are being weaned, and by young children as a supplement to their diet or for their progressive adaptation to ordinary food or both;

“Directive” means Commission Directive 96/5/EC⁵ , Euratom of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children, as amended by Commission Directive 98/36/EC⁶ of 2 June 1998, and Commission Directive 1999/39/EC⁷ of 6 May 1999, and Commission Directive 2003/13/EC⁸ of 10 February 2003;

“food” or “foodstuff” means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be, ingested by humans;

“food” includes drink, chewing gum and any substance, including water, intentionally incorporated into the food during its manufacture, preparation or treatment. It includes water after the point of compliance as defined in Article 6 of Directive 98/83/EC⁹ , without prejudice to the requirements of Directives 80/778/EEC¹⁰ and 98/83/EC⁹ ;

“food” shall not include -

• (a) feed,

• (b) live animals unless they are prepared for placing on the market for human consumption,

• (c) plants prior to harvesting,

• (d) medicinal products within the meaning of Council Directives 65/65/EEC¹¹ and 92/73/EEC¹² ,

• (e) cosmetics within the meaning of Council Directive 76/768/EEC¹³ ,

• (f) tobacco and tobacco products within the meaning of Council Directive 89/622/EEC¹⁴ ,

• (g) narcotic or psychotropic substances within the meaning of the United Nations Single Convention on Narcotic Drugs, 1961, and the United Nations Convention on Psychotropic Substances, 1971, or

• (h) residues and contaminants;

“import” means importation from a country other than a Member State, save in the context of Regulation 3(5) where ‘imported’ means importation from a Member State into a country other than a Member State;

“infants” means children under the age of 12 months;

“manufacture” includes the production and processing of food, other than primary production for private domestic use and domestic preparation, handling and storage of food for private domestic consumption, and cognate words shall be construed accordingly;

“Member State” means a Member State of the European Community and shall be construed as including reference to those States that are Contracting Parties to the EEA Agreement;

“Minister” means the Minister for Health and Children;

“official agency” means an official agency carrying out functions under a service contract and acting on behalf of the Authority pursuant to section 48 of the Act of 1998;

“official laboratory” in these Regulations means -

• (a) the Food Microbiology Laboratory, Cork,

• (b) the Food Microbiology Laboratory, Galway,

• (c) the Microbiology Laboratory, Dublin,

• (d) the Microbiology Laboratory, Limerick,

• (e) the Public Analyst’s Laboratory, Cork,

• (f) the Public Analyst’s Laboratory, Dublin,

• (g) the Public Analyst’s Laboratory, Galway,

• (h) the Public Health Laboratory, Sligo,

• (i) the Public Health Laboratory, Waterford, or

• (j) a laboratory designated by the Minister pursuant to Regulation 16;

“pesticide residue” means the residue in processed cereal-based foods and baby foods of a plant protection product, as defined in point 1 of Article 2 of Council Directive 91/414/EEC¹⁵ , as amended, including its metabolites and products resulting from its degradation or reaction, and cognate words shall be construed accordingly;

“place on the market” means -

• (a) import,

• (b) sell,

• (c) offer or expose for sale,

• (d) invite the making by a person of an offer to purchase,

• (e) distribute free of charge,

• (f) supply for any of those purposes (whether or not for profit)

and cognate words shall be construed accordingly;

“processed cereal-based foods” means foodstuffs for particular nutritional use fulfilling the particular requirements of infants and young children in good health and intended for use by infants while they are being weaned, and by young children as a supplement to their diet or for their progressive adaptation to ordinary food or both, and divided into the following four categories -

• (a) simple cereals which are, or have to be, reconstituted with milk or other appropriate nutritious liquids,

• (b) cereals with an added high protein food which are or have to be reconstituted with water or other protein-free liquid,

• (c) pastas which are to be used after cooking in boiling water or other appropriate liquids, and

• (d) rusks and biscuits which are to be used either directly, or, after pulverisation, with the addition of water, milk or other suitable liquids;

“service contract” means a contract entered into between the Authority and an official agency pursuant to section 48 of the Act of 1998;

“young children” means children aged between 1 and 3 years.

• (2) A word or expression which is used in these Regulations and which is also used in the Directive has, unless the context otherwise requires, the same meaning in these Regulations as it has in the Directive.

• (3)
• (a) A reference in these Regulations to a Regulation is to a Regulation of these Regulations, unless it is indicated that reference to some other Regulations is intended.

• (b) A reference in these Regulations to a paragraph or subparagraph is to the paragraph or subparagraph of the provision in which the reference occurs, unless it is indicated that reference to some other provision is intended.

• (c) A reference in these Regulations to a Schedule is to a Schedule to these Regulations, unless it is indicated that reference to some other Regulations is intended.

PART 2 General Provisions

3.

• (2) The foodstuffs referred to at paragraph (1) comprise processed cereal-based foods and baby foods.

• (3) These Regulations shall not apply to milks intended for young children.

• (4) A person shall not -

• (a) manufacture processed cereal-based foods or baby foods, or products presented as such, or

• (b) place processed cereal-based foods or baby foods, or products presented as such, on the market,

unless the requirements of these Regulations are complied with.

• (5) A person is only required to comply with paragraph (4)(a) insofar as the country into which the foods are intended to be imported does not otherwise stipulate or request by its provisions.

• (6) Agricultural products intended for the production of processed cereal-based foods or baby foods shall be treated in accordance with the requirements of these Regulations.

4.

• (2) Processed cereal-based foods shall comply with the compositional criteria specified in Schedule 1.

• (3) Baby foods which are described in Schedule 2 shall comply with the compositional criteria specified therein.

• (4) Only the nutritional substances listed in Schedule 4 may be added in the manufacture of processed cereal-based foods and baby foods.

• (5) Notwithstanding paragraph (4), a substance listed in Schedule 6 shall not be added in the manufacture of processed cereal-based foods and baby foods in a quantity that is greater than the maximum permitted level for that substance as specified in that Schedule.

• (6) Processed cereal-based foods and baby foods shall not contain any substance in such quantity as to endanger the health of infants and young children.

• (7) Processed cereal-based foods and baby foods shall not contain residues of individual pesticides at levels exceeding 0.01 mg per kg, except for those substances for which specific levels have been set in Schedule 7, in which case those specific levels shall apply.

• (8) The levels referred to at paragraph (7) apply to processed cereal-based foods and baby foods as proposed ready for consumption or as reconstituted according to the instructions of the manufacturer.

• (9) Analytical methods for determining the levels of pesticide residues shall be generally acceptable standardised methods.

• (10) Those pesticides listed in Schedule 8 shall not be used in agricultural products intended for the production of processed cereal-based foods and baby foods. However, for the purpose of control, pesticides listed in Tables 1 and 2 of Schedule 8 are considered not to have been used if their residues do not exceed a level of 0.003mg per kg.

• (11) The levels referred to in paragraph (10) shall apply to the products as proposed ready for consumption or as reconstituted according to the instructions of the manufacturers.

5.

• (a) a statement as to the appropriate age from which the product may be used, with regard to its composition, texture or other particular properties. The stated age shall not be less than 4 months for any product. Products recommended for use from the age of 4 months may indicate that they are suitable from that age unless independent persons having qualifications in medicine, nutrition or pharmacy, or other professionals responsible for maternal and child care, advise otherwise.

• (b) information as to the presence or absence of gluten if the indicated age from which the product may be used is below 6 months,

• (c) the available energy value expressed in kJ and kcal, and the protein, carbohydrate and lipid content, expressed in numerical form, per 100 g or 100 ml of the product as sold and, where appropriate, per specified quantity of the product as proposed for consumption,

• (d) the average quantity of each mineral substance and of each vitamin governed by a specific level in Schedules 1 and 2 respectively, expressed in numerical form, per 100g or 100ml of the product as sold and, where appropriate, per specified quantity of the product as proposed for consumption, and

• (e) instructions for appropriate preparation, when necessary, and a statement as to the importance of following those instructions.

• (2) The labelling of processed cereal-based foods and baby foods may bear -

• (a) the average quantity of the nutrients set out in Schedule 4 when such declaration is not covered by the provisions of paragraph (1)(d), expressed in numerical form, per 100g or 100ml of the product as sold and, where appropriate, per specified quantity of the product as proposed for consumption, and

• (b) in addition to numerical information, information on vitamins and minerals shown in Schedule 5, expressed as a percentage of the reference values given therein, per 100g or 100ml of the product as sold, and where appropriate, per specified quantity of the product as proposed for consumption, provided that the quantities present are at least equal to 15% of the reference values.

PART 3 Enforcement

6.

7.

8.

9.

• (2) An authorised officer may, for the purpose of taking a sample of processed cereal-based foods or baby foods, open any receptacle.

• (3) Where an authorised officer purchases or takes without payment, with the intention of having it analysed, a sample of processed cereal-based foods or baby foods which are suspected by him or her to fail to comply with the provisions of these Regulations, he or she may, by notice in writing to the seller, owner or person in apparent charge or control of such processed cereal-based foods or baby foods, prohibit the removal of the processed cereal-based foods or baby foods except to any place which may be specified in the notice, during such period as may be specified in the notice, but not exceeding 15 days from the date of the detention of the sample.

• (4) Where an authorised officer purchases or takes without payment a sample of processed cereal-based foods or baby foods with the intention of having it analysed, he or she shall after purchasing or taking the sample forthwith notify the seller, owner or person in apparent charge or control of the processed cereal-based foods or baby foods of his or her intention of having the sample analysed.

10.

• (2) Where an authorised officer takes a sample consisting of processed cereal based foods or baby foods contained in unopened containers and its division into parts-

• (a) is not reasonably practicable, or

• (b) might affect the composition or impede the proper analysis of the sample,

the provisions of paragraph (1) of this Regulation as regards the division of samples into parts shall be deemed to be complied with if the authorised officer divides the containers into three lots and deals with each lot as if it were a sample as specified under paragraph (1) of this Regulation.

• (3) In proceedings for an offence under these Regulations, the result of any test, examination or analysis of, or report on a sample of processed cereal-based foods or baby foods taken pursuant to these Regulations, shall not be adduced unless before the proceedings were instituted the sample was divided as specified in paragraphs (1) and (2) of this Regulation. The part, package or container retained by the authorised officer shall be produced at the hearing.

11.

• (2) An official certificate given in accordance with paragraph (1) of this Regulation shall be prima facie evidence of the matters contained therein until the contrary is proved.

12.

• (a) the Authority, where the officer was appointed by the Authority, or

• (b) the official agency, where the officer was appointed by an official agency

and the Authority, or the official agency (as the case may be), shall comply with such request.

13.

14.

• (a) products which are not baby foods or processed cereal-based foods, as defined in Regulation 2(1), but which are being placed on the market as such, and

• (b) any other products which the authorised officer suspects are being treated, manufactured or placed on the market in contravention of these Regulations.

15.

• (2) An authorised officer may, with the consent in writing of the owner or person in apparent charge or control of such processed cereal-based foods, baby foods or other products or in accordance with an order of a judge of the District Court under paragraph (4) of this Regulation, destroy or otherwise dispose of same so as to prevent them being used for human consumption.

• (3) An authorised officer who has seized, removed, detained or directed the withdrawal from the market of, processed cereal-based foods, baby foods or other products in pursuance of the provisions of this Regulation may, on giving notice in writing to the owner or person in apparent charge or control of such products of his or her intention to do so, apply to a judge of the District Court for an order directing that such products be destroyed or otherwise disposed of.

• (4) A judge of the District Court, to whom an application is made for an order under paragraph (3), may, if satisfied that such products fail to comply with these Regulations, order that they be destroyed or otherwise disposed of, after such period, not exceeding 14 days, as may be specified in such order, and an authorised officer shall destroy or dispose of them accordingly.

16.

• (a) a laboratory as a laboratory at which samples taken under these Regulations may be analysed, and testing and verification may be carried out, and

• (b) a person as being a person who, or a class of persons the members of which, may, at a designated laboratory, engage in analysis, testing and verification for the purposes of these Regulations.

17.

• (2) Paragraph (1) shall not apply to an authorised officer acting in the course of his or her duties pursuant to these Regulations.

18.

19.

• (2) Any person who alters with intent to defraud or deceive, or who utters knowing it to be so altered, a certificate of analysis or other document issued, granted or given under these Regulations, or required for the purposes of these Regulations (hereafter in this Regulation referred to as “an altered document”), is guilty of an offence.

• (3) Any person who, without lawful authority, has in his or her possession a forged document or an altered document is guilty of an offence.

• (4) Any person who, with intent to defraud or deceive -

• (a) tampers with any thing so as to procure that any sample taken pursuant to these Regulations does not correctly represent the substance sampled, or

• (b) tampers or interferes with any sample taken under these Regulations

is guilty of an offence.

20.

• (2) A person who is guilty of an offence under these Regulations shall be liable on summary conviction to a fine not exceeding €3,000 or at the discretion of the court to imprisonment for a term not exceeding 12 months or both.

21.

• (a) the Authority, or

• (b) an official agency.

PART 4 Revocations

22.

• (2) References in any other instrument to the Regulations revoked under paragraph (1) shall be construed as references to these Regualtions, as appropriate.

Schedule 1 Essential Composition of Processed Cereal-Based 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.

Processed cereal-based foods are prepared primarily from one or more milled cereals and/or starchy root products.

The amount of cereal and/or starchy root shall not be less than 25% of the final mixture on a dry weight for weight basis.

2.1 For products mentioned in subparagraphs (b) and (d) of the definition of processed cereal-based foods in paragraph (1) of Regulation 2, the protein content shall not exceed 1.3g/100 kJ (5.5g/100 kcal).

2.2 For products mentioned in subparagraph (b) of the definition of processed cereal-based foods in paragraph (1) of Regulation 2, the added protein shall not be less than 0.48g/100 kJ (2g/100 kcal).

2.3 For biscuits mentioned in subparagraph (d) of the definition of processed cereal-based foods in paragraph (1) of Regulation 2, 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 (1.5/100 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 energy 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 is permitted solely for the purpose of improving the nutritional value of the protein mixture, and only in the proportions necessary for that purpose.

3.1 If sucrose, fructose, glucose, glucose syrups or honey are added to products mentioned in subparagraphs (a) and (d) of the definition of processed cereal-based foods in paragraph (1) of Regulation 2:

• 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 subparagraph (b) of the definition of processed cereal-based foods in paragraph (1) of Regulation 2,

• 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).

4.1 For products mentioned in subparagraphs (a) and (d) of the definition of processed cereal-based foods in paragraph (1) of Regulation 2, the lipid content shall not exceed 0.8g/100 kJ (3.3g/100 kcal).

4.2 For products mentioned in subparagraph (b) of the definition of processed cereal-based foods in paragraph (1) of Regulation 2, 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):

• (a) the amount of lauric acid shall not exceed 15% of the total lipid content;

• (b) the amount of myristic acid shall not exceed 15% of the total lipid content;

• (c) 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 (1,200mg/ 100 kcal).

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 (10 mg/ 100 kcal).

5.2. Calcium

5.2.1 For products mentioned in subparagraph (b) of the definition of processed cereal-based foods in paragraph (1) of Regulation 2, the amount of calcium shall not be less than 20mg/ 100 kJ (80mg/ 100 kcal).

5.2.2 For products mentioned in subparagraph (d) of the definition of processed cereal-based foods in paragraph (1) of Regulation 2, 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).

6.1 For processed cereal-based foods the amount of thiamin shall not be less than 2.5 μg/100 kJ (100μg/100 kcal).

6.2 For products mentioned in subparagraph (b) of the definition of processed cereal-based foods in paragraph (1) of Regulation 2:

	Per 100 kJ	Per 100 kJ	Per 100 kcal	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	1 RE = all trans retinol equivalents	1 RE = all trans retinol equivalents	1 RE = all trans retinol equivalents	1 RE = all trans retinol equivalents
2 In the form of cholecalciferol, of which 10μg = 400 i.u. of vitamin D.	2 In the form of cholecalciferol, of which 10μg = 400 i.u. of vitamin D.	2 In the form of cholecalciferol, of which 10μg = 400 i.u. of vitamin D.	2 In the form of cholecalciferol, of which 10μg = 400 i.u. of vitamin D.	2 In the form of cholecalciferol, of which 10μg = 400 i.u. of vitamin D.

These limits are also applicable if vitamins A and D are added to other processed cereal-based foods.

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.

1.1 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/100kJ (7g/100 kcal).

1.2 If meat, poultry, fish, offal or other traditional source of protein, singly 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 1 g/ 100 kJ (4g / 100 kcal).

1.3 If meat, poultry, fish, offal or other traditional source of protein singly 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).

1.3a 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)

1.4 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, then the total protein in the product from all sources shall not be less than 0.7g/ 100 kJ (3g/100 kcal).

1.4a Sauces presented as an accompaniment to a meal are exempt from the requirements of sections 1.1 to 1.4 inclusive.

1.4b Sweet dishes that mention dairy products as the first or only ingredient in the name shall contain not less than 2.2g dairy protein/100kcal. All other sweet dishes are exempt from the requirements in 1.1 to 1.4.

1.5 The addition of amino acids is permitted solely for the purpose of improving the nutritional value of the protein present, and only in the proportions necessary for that purpose.

The quantities of total carbohydrates present in fruit and vegetable juices and nectars, fruit-only dishes, and desserts or puddings shall not exceed:

• 10g/ 100 ml for vegetable juices and drinks based on them,

• 15g/ 100 ml for fruit juices and nectars and drinks based on them,

• 20g/ 100 g for fruit-only dishes,

• 25g/ 100 g for desserts and puddings,

• 5g/ 100 g for other non-milk-based drinks.

3.1 For products referred to in point 1.1 of this Schedule, if meat or cheese are the only ingredients or are mentioned first in the name of a product, then the total fat in the product from all sources should not exceed 1.4g/ 100 kJ (6g/ 100 kcal).

3.2 For all other products the total fat in the product from all sources should not exceed 1.1g / 100 kJ (4.5g/ 100 kcal).

4.1 The final sodium content in the product should be either not more than 48mg/ 100 kJ (200mg/ 100 kcal) or not more than 200 mg per 100g. However, if cheese is the only ingredient mentioned in the name of the product, the final sodium content in the product should 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.

Vitamin C

In a fruit juice, nectar, or vegetable juice the final content of vitamin C in the product should 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 should be not less than 25μg RE/ 100 kJ (100μg RE/ 100 kcal)¹⁷

Vitamin A shall not be added to other baby foods.

Vitamin D

Vitamin D shall not be added to baby foods.

Schedule 3 Amino Acid Composition of Casein

(g per 100 g of protein)	(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

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

Choline

Choline chloride

Choline citrate

Choline bitartrate

Inositol

L-Carnitine

L-carnitine hydrochloride

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 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	(μg) 400
Vitamin D	(μg) 10
Vitamin C	(mg) 25
Thiamin	(mg) 0.5
Riboflavin	(mg) 0.8
Niacin equivalents	(mg) 9
Vitamin B6	(mg) 0.7
Folate	(μg) 100
Vitamin B12	(μg) 0.7
Calcium	(mg) 400
Iron	(mg) 6
Zinc	(mg) 4
Iodine	(μg) 70
Selenium	(μg) 10
Copper	(mg) 0.4

Schedule 6 Maximum limits for vitamins, minerals and trace elements, if added, in processed cereal-based foods and baby foods intended 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, except for potassium and calcium for which the requirements refer to the product as sold.

Nutrient	Maximum per 100 kcal
Vitamin A (μg RE)	1801
Vitamin E (mg a —TE)	3
Vitamin C (mg)	12.5/252/1253
Thiamin (mg)	0.25/0.54
Riboflavin (mg)	0.4
Niacin (mg NE)	4.5
Vitamin B6 (mg)	0.35
Folic acid (μg)	50
Vitamin B12 (μg)	0.35
Pantothenic acid (mg)	1.5
Biotin (μg)	10
Potassium (mg)	160
Calcium (mg)	80/1805/1006
Magnesium (mg)	40
Iron (mg)	3
Zinc (mg)	2
Copper (μg)	40
Iodine (μg)	35
Manganese (mg)	0.6

¹ In accordance with the provisions of Schedules 1 and 2.

² Limit applicable to products fortified with iron.

³ Limit applicable to fruit-based dishes, fruit juices, nectars and vegetable juices.

⁴ Limit applicable to processed cereal-based foods.

⁵ Limit applicable to products mentioned in subparagraphs (a) and (b) of the definition of processed cereal-based foods in paragraph (1) of Regulation 2.

⁶ Limit applicable to products mentioned in subparagraph (d) of the definition of processed cereal-based foods in paragraph (1) of Regulation 2.

Schedule 7 Specific maximum residue levels of pesticides or metabolites of pesticides in processed cereal-based foods and baby foods

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 8 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 9

Form of official 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 2004

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 this 13th day of July 2004.
	Micheál Martin, T.D. 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 96/5/EC, Euratom of 16 February 1996 on processed cereal-based foods and baby foods for infants and young children, as amended by Commission Directive 98/36/EC of 2 June 1998, and Commission Directive 1999/39/EC of 6 May 1999, and Commission Directive 2003/13/EC of 10 February 2003.

These Regulations revoke the European Communities (Processed Cereal-Based Foods and Baby Foods for Infants and Young Children) Regulations 2000 ( S.I. No. 142 of 2000 ).

These Regulations may be cited as the European Communities (Processed Cereal-Based Foods and Baby Foods for Infants and Young Children) Regulations 2004.

Footnotes