Infant formula

Provisions on, for example, the composition and mandatory packaging markings are set out in the Decree of the Ministry of Trade and Industry on infant formula and follow-on formula (1216/2007). Link to the Decree (in Finnish): http://www.finlex.fi/fi/laki/alkup/2007/20071216

Annexes to the Decree—23 pages—specify the current requirements on the composition, and these can be found by following the link at the bottom of the text.
The mandatory information that must be included on the packaging must also be entered in the Data Pool. It is possible to provide more information in the Data Pool than on the product packaging. GS1 gives instructions on how to report information in the Data Pool, but GS1 is not responsible for interpretation of the law.

Contents

Mandatory information
Mandatory additional information on infant formula and follow-on formula
Additional information on infant formula
Additional information on follow-on formula
Storage and disposal

Mandatory information

Infant formula and follow-on formula are governed by the legislation on the packaging markings for food stuffs, which means that certain information must be provided on the packaging and in the Data Pool.
The mandatory information are specified in section 12 of the Decree.

Ingredient statement F7018

Use the Synkka Product Ingredient Statement F7018 to report the ingredients of infant formula and follow-on formula. The maximum length of the ingredient statement is 5,000 characters per language.
The ingredients must be listed in both Finnish and Swedish.
Allergens must be highlighted on the packaging (optional methods) and in the Data Pool in CAPITAL LETTERS.

Allergens F7004

The allergens on the ingredient statement must also be listed on the list of allergens F7004.

Vitamins and minerals F7031

The vitamins and minerals in the product must be listed on the Vitamins/minerals F7031 list.
The list must include all the vitamins and minerals that are available in the Data Pool.
If your product contains a vitamin/mineral/vitamin-like substance that is not listed in the Data Pool, disclose it at the end of the ingredient statement. Below are some examples of substances not found in the pool:

  • Nucleotides
  • Choline
  • Inositol
  • Taurine

The section on vitamins and minerals must include all the vitamins and minerals referred to in Annexes I and II and, if necessary, choline, inositol and carnitine, expressed as the average amount per 100 ml of product that is ready for consumption.

Note! Please report choline, inositol and carnitine at the end of the ingredient statement.

In addition to the quantities of vitamins and minerals referred to in Annex VII, the packaging for a follow-on formula may include the percentage of the reference daily intake of the nutrient, as specified in the annex, per 100 ml of product ready for consumption.

Nutrient content

The packaging and the Data Pool must disclose the energy content of the product as kilojoules (kJ) and kilocalories (kcal), as well as the content of protein, fat and carbohydrate in numbers per 100 ml of product ready for consumption.

Mandatory additional information on infant formula and follow-on formula

In addition to the other information required by the food stuff regulations, infant formula and follow-on formula must be equipped with other mandatory information.

Instructions for use

Enter the instructions for use that are on the packaging in the Preparation Instructions F7028 section.
The maximum length of the instructions for use is 2,500 characters. The instructions for use can be provided in more than one language.
The instructions for the use of infant formula and follow-on formula must be provided in at least Finnish and Swedish.

Preparation type

In addition to the Preparation Instructions (F7028), you must select the product’s Preparation Type (F7037) from the list.
The alternatives include:

  • READY_TO_EAT No other preparation is required besides removing the packaging.
  • HEAT_AND_SERVE Requires heating.
  • MICROWAVING Requires heating in a microwave.

Additional information on infant formula

The Decree specifies a group of additional information which must be disclosed on infant formula packaging:
1) infant formula must be equipped with an indication that the product is suitable as infant food from birth if the baby is not breast-fed;
2) infant formula must be equipped with the following information under the word Important or other similar expression:
– statement on the superiority of breast feeding; and
– recommendation, stating that the product should only be used following the instructions of independent experts who have undergone medical, nutritional or pharmaceutical training or work as professionals in maternity or child care.

This additional information is entered on the ingredient statement (F7018) in the Data Pool.

First, enter the ingredients listed on the product’s ingredient statement, followed by the vitamins/minerals not found in the Data Pool and conclude with this additional information.

Additional information on follow-on formula

This additional information is entered on the ingredient statement (F7018) in the Data Pool.
First, enter the ingredients listed on the product’s ingredient statement, followed by the vitamins/minerals not found in the Data Pool and conclude with this additional information.

Storage and disposal

Infant formula and follow-on formula must be equipped with appropriate instructions for preparation, storage and disposal, along with a warning about the health hazards associated with incorrect preparation or storage methods.

In the Data Pool, these are reported in the Consumer Storage Instructions (F7252) section. The maximum length is 1,000 characters.

Infant formula and follow-on formula must include this information in at least Finnish and Swedish.

Revision history

Date Revision made
23.12.2016 Document translation ready