EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10355/2015 ANNEX (POOL/E4/2015/10355/10355-EN ANNEX.doc) […](2015) XXX  draft 
ANNEXES 1 to 6 
  
ANNEXES 
to the 
COMMISSION DELEGATED REGULATION (EU) …/... 
supplementing Regulation (EU) No 609/2013 of the European Parliament and of the 
Council as regards the specific composit ional and information requirements for 
processed cereal-based food and baby food 
  
EN 2   EN ANNEX I  
COMPOSITIONAL REQUIREMENTS REFERRED TO IN ARTICLE 2(2) 
1. CEREAL CONTENT 
Processed cereal-based food shall be prep ared primarily from one or more milled 
cereals and/or starchy root products. 
The amount of cereal and/or starchy root sh all not be less than 25 % of the final 
mixture on a dry weight for weight basis. 
2. PROTEIN 
2.1. For cereals with an added high protein f ood which are or have to be reconstituted 
with water or other protein- free liquid and rusks and biscuits which are to be used 
either directly or, after pulverisation, with  the addition of water, milk or other 
suitable liquids, the protein content shall not exceed 1,3 g/100 kJ (5,5 g/100 kcal).  
2.2. For cereals with an added high protein f ood which are or have to be reconstituted 
with water or other protein-free liquid, th e added protein shall not be less than 
0,48 g/100 kJ (2 g/100 kcal). 
2.3. For biscuits which are to be used either  directly or, after pulverisation, with the 
addition of water, milk or other suitable liquids, made with the addition of a high 
protein food, and presented as such, the added protein shall not be less than 
0,36 g/100 kJ (1,5 g/100 kcal).  
2.4. The chemical index of the added protein sha ll be equal to at least 80 % of that of the 
reference protein (casein as set out in Tabl e 1), 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 ami no 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. 
Table 1 
Amino acid composition of casein 
(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  
EN 3   EN 3. CARBOHYDRATES 
3.1. If sucrose, fructose, glucose, glucose sy rups or honey are added to simple cereals 
which are or have to be reconstituted with milk or other appropriate nutritious liquids 
and rusks and biscuits which are to be used  either directly or , after pulverisation, 
with the addition of water, m ilk or other suitable liquids: 
– the amount of added carbohydrates from  these sources shall not exceed 
1,8 g/100 kJ (7,5 g/100 kcal), 
– the amount of added fructose shall not exceed 0,9 g/100 kJ (3,75 g/100 kcal). 
3.2. If sucrose, fructose, glucose syrups or honey are added to cereals with an added high 
protein food which are or have  to be reconstituted with water or other protein-free 
liquid: 
– the amount of added carbohydrates from  these sources shall not exceed 
1,2 g/100 kJ (5 g/100 kcal), 
– the amount of added fructose shall not exceed 0,6 g/100 kJ (2,5 g/100 kcal). 
4. LIPIDS 
4.1. For simple cereals which are or have to  be reconstituted w ith milk or other 
appropriate nutritious liquids and rusks and biscuits which are to be used either 
directly or, after pulverisati on, with the addition of water,  milk or other suitable 
liquids, the lipid content shall not ex ceed 0,8 g/100 kJ (3,3 g/100 kcal). 
4.2. For cereals with an added high protein f ood which are or have to be reconstituted 
with water or other protein-free liquid, the lipid content shall not  exceed 1,1 g/100 kJ 
(4,5 g/100 kcal). If the lipid conten t exceeds 0,8 g/100 kJ (3,3 g/100 kcal): 
– the amount of lauric acid shall not ex ceed 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 = linol eates) shall not be 
less than 70 mg/100 kJ (300 mg/100 kcal ) and shall not exceed 285 mg/100 kJ 
(1 200 mg/100 kcal). 
5. MINERALS 
5.1. Sodium 
5.1.1. Sodium salts may only be added to pr ocessed cereal-based food for technological 
purposes. 
5.1.2. The sodium content of processed cereal-b ased food shall not exceed 25 mg/100 kJ 
(100 mg/100 kcal). 
5.2. Calcium 
5.2.1. For cereals with an added high protein f ood which are or have to be reconstituted 
with water or other protein- free liquid, the amount of calcium shall not be less than 
20 mg/100 kJ (80 mg/100 kcal). 
5.2.2. For rusks and biscuits which are to be used either directly  or, after pulverisation, with 
the addition of water, milk or other su itable liquids, manufactured with the addition 
of milk (milk biscuits ) and presented as such, the amount  of calcium shall not be less 
than 12 mg/100 kJ (50 mg/100 kcal).  
EN 4   EN 6. VITAMINS 
6.1. For processed cereal-based food, the amount  of thiamin shall not be less than 
25 μg/100 kJ (100 μg/100 kcal). 
6.2. For cereals with an added high protein f ood which are or have to be reconstituted 
with water or other protein-free liquid, th e limits set out in Table 2 shall apply. 
Those limits shall also apply where vitami ns A and D are added to other processed 
cereal-based foods. 
 Table 2 
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 10 μg = 400 i.u. of vitamin D.   
7. MAXIMUM LIMITS FOR VITA MINS, MINERALS AND TRACE 
ELEMENTS, IF ADDED 
The maximum limits set out in Table 3 shall apply. By  way of derogation from 
Article 2(4), the limits fo r potassium and calcium refe r to the product as sold. 
Table 3 
Nutrient Maximum per 100 kcal 
Vitamin A ( μg RE) 180 
Vitamin E (mg α-TE)(1)  3 
Vitamin D ( μg) 3 
Vitamin C (mg) 12,5/25(2) 
Thiamin (mg) 0,5 
Riboflavin (mg) 0,4 
Niacin (mg NE)(3) 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) 80/180(4) /100(5) 
Magnesium (mg) 40 
Iron (mg) 3  
EN 5   EN Zinc (mg) 2 
Copper (μg) 40 
Iodine (μg) 35 
Manganese (mg) 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 simple cereals which are or  have to be reconstituted with milk or other 
appropriate nutritious liquids, and cereals with an added high protein food which are or have to 
be reconstituted with water or other protein-free liquid. 
(5) Limit applicable to rusks and biscuits which are to  be used either directly or, after pulverisation, 
with the addition of water, milk or other suitable liquids.   
EN 6   EN ANNEX II  
COMPOSITIONAL REQUIREMENTS REFERRED TO IN ARTICLE 2(3)  
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: 
– the named meat, poultry, fish, offal or other traditional protein source, in total, 
shall constitute not less than 40 % by weight of th e total product, 
– each named meat, poultry, fish, offal or ot her traditional source of protein shall 
constitute not less than 25 %, by wei ght, of total named protein sources, 
– the total protein from the named sources shall not be less than 1,7 g/100 kJ 
(7 g/100 kcal). 
1.2. If meat, poultry, fish, offal or other trad itional source of protei n, singularly or in 
combination, are mentioned first in the na me of the product, whether or not the 
product is presented as a meal: 
– the named poultry, fish, offal or other trad itional protein source, in total, shall 
constitute not less than 10 % by weight of the total product, 
– each named meat, poultry, fish, offal or ot her 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 
(4 g/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: 
– the named meat, poultry, fish, offal or other traditional protein source, in total, 
shall constitute not less than 8 % by weight of th e total product, 
– each named meat, poultry, fish, offal or ot her traditional source of protein shall 
constitute not less than 25 %, by wei ght, of total named protein sources, 
– the protein from the named sources shall not be less than 0,5 g/100 kJ 
(2,2 g/100 kcal), 
– the total protein in the product from all sources shall not be less than 
0,7 g/100 kJ (3 g/100 kcal). 
1.4. If cheese is mentioned together with ot her ingredients in the name of a savoury 
product, whether or not the pr oduct is presented as a meal: 
– the protein from the dairy sources shall not be less than 0,5 g/100 kJ 
(2,2 g/100 kcal), 
– the total protein in the product from all sources shall not be less than 
0,7 g/100 kJ (3 g/100 kcal). 
1.5. If the product is designated on the la bel as a meal, but does not mention meat, 
poultry, fish, offal or other traditional sour ce of protein in the name of the product, 
the total protein in the product from all so urces shall not be le ss than 0,7 g/100 kJ 
(3 g/100 kcal).  
EN 7   EN 1.6. Sauces presented as an accompaniment to a meal shall be exempt from the 
requirements of points 1.1 to 1.5. 
1.7. Sweet dishes that mention dairy products as  the first or only ingredient in the name 
shall contain not less than 2,2 g dairy protein/100 kcal. A ll other sweet dishes shall 
be exempt from the requirements in 1.1 to 1.5. 
1.8. The addition of amino acids shall be pe rmitted solely for the purpose of improving 
the nutritional value of the protein present,  and only in the proportions necessary for 
that purpose. 
2. CARBOHYDRATES 
The quantities of total carbohydr ates present in fruit and ve getable juices and nectars, 
fruit-only dishes, and desserts or puddings shall not exceed: 
– 10 g/100 ml for vegetable juices and drinks based on them, 
– 15 g/100 ml for fruit juices and nectars and drinks based on them, 
– 20 g/100 g for fruit-only dishes, 
– 25 g/100 g for desserts and puddings, 
– 5 g/100 g for other non-milk-based drinks. 
3. 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 1,4 g/100 kJ 
(6 g/100 kcal). 
3.2. For all other products, the total fat in the product from all sources shall not exceed 
1,1 g/100 kJ (4,5 g/100 kcal). 
4. SODIUM 
4.1. The final sodium content in the product shall be either not more than 48 mg/100 kJ 
(200 mg/100 kcal) or not more than 200 mg  per 100 g. 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 70 mg/100 kJ (300 mg/100 kcal). 
4.2. Sodium salts may not be added to products  based on fruit, nor to desserts, puddings 
except for technological purposes. 
5. VITAMINS 
Vitamin C 
In a fruit juice, nectar, or vegetable juice the final conten t of vitamin C in the product 
shall be either not less than 6 mg/100 kJ  (25 mg/100 kcal) or not less than 25 mg per 
100 g. 
Vitamin A 
In vegetable juices, the final content of vita min A in the product shall be not less than 
25 μg RE/100 kJ (100 μg RE/100 kcal). 
Vitamin A shall not be added to other baby food.  
EN 8   EN Vitamin D 
Vitamin D shall not be added to baby food. 
6. MAXIMUM LIMITS FOR VITA MINS, MINERALS AND TRACE 
ELEMENTS, IF ADDED 
The maximum limits set out in Table 1 shall apply. By  way of derogation from 
Article 2(4), the limits fo r potassium and calcium refe r to the product as sold. 
Table 1 
Nutrient Maximum per 100 kcal 
Vitamin A ( μg RE) 180(1) 
Vitamin E (mg α-TE) 3 
Vitamin C (mg) 12,5/25(2)/125(3) 
Thiamin (mg) 0,25 
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 
Magnesium (mg) 40 
Iron (mg) 3 
Zinc (mg) 2 
Copper (μg) 40 
Iodine (μg) 35 
Manganese (mg) 0,6 
(1) In accordance with point 5. 
(2) Limit applicable to products fortified with iron. 
(3) Limit applicable to fruit-based dishes, fruit juices, nectars and vegetable juices.   
EN 9   EN ANNEX III  
ACTIVE SUBSTANCES REFERRED  TO IN ARTICLE 3(3) 
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  
EN 10   EN ANNEX IV  
ACTIVE SUBSTANCES REFERRED  TO IN ARTICLE 3(4) 
Chemical name of the substance (residue definition) 
Aldrin and dieldrin, expressed as dieldrin  
Disulfoton (sum of disulfoton, disulfoton sulf oxide and disulfoton sulfone expressed as 
disulfoton) 
Endrin 
Fensulfothion (sum of fensulfothion, its oxyge n analogue and their sulfones, expressed as 
fensulfothion) 
Fentin, expressed as triphenyltin cation 
Haloxyfop (sum of haloxyfop, its  salts and esters includi ng conjugates, expressed as 
haloxyfop) 
Heptachlor and trans -heptachlor epoxide, expressed as heptachlor 
Hexachlorobenzene 
Nitrofen 
Omethoate 
Terbufos (sum of terbufos, its sulfoxi de and sulfone, expressed as terbufos)  
EN 11   EN ANNEX V  
REFERENCE INTAKES REFERRED TO IN ARTICLE 5(6) 
Nutrient Reference intake 
Vitamin A ( μg) 400 
Vitamin D ( μg) 7 
Vitamin E (mg TE) 5 
Vitamin K ( μg) 12 
Vitamin C (mg) 45 
Thiamin (mg) 0,5 
Riboflavin (mg) 0,7 
Niacin  (mg) 7 
Vitamin B6 (mg) 0,7 
Folate ( μg) 125 
Vitamin B12 ( μg) 0,8 
Pantothenic acid (mg) 3 
Biotin ( μg) 10 
Calcium (mg) 550 
Phosphorus (mg) 550 
Potassium (mg) 1 000 
Chloride (mg) 500 
Iron (mg) 8 
Zinc (mg) 5 
Iodine ( μg) 80 
Selenium ( μg) 20 
Copper (mg) 0,5 
Magnesium (mg) 80 
Manganese (mg) 1,2