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Warning labelling and instructions for use

Provisions on food safety are contained in article 14 of the General Food Law Regulation (EC) 178/2002.

Under article 14 of the General Food Law Regulation, food must not be placed on the market if it is unsafe. Food is considered unsafe if it is injurious to human health or unfit for human consumption. When the safety of food is assessed, consideration must be given to the normal conditions of use and the information provided to the consumer concerning the avoidance of adverse health effects of particular foodstuffs. When assessing whether a foodstuff is injurious to health, consideration must be given to the following:

  • the immediate, short-term and long-term effects that the foodstuff may have on the health of the person consuming it
  • he effects on subsequent generations
  • any cumulative toxic effects, and
  • the particular health sensitivities of a specific category of consumers should the food be intended for that category.

According to Directive 2000/13/EC (implemented in Finland by the Decree of the Ministry of Trade and Industry on the Labelling of Foodstuffs, 1084/2004), the packaging for a food must, if necessary, carry instructions for use for consumer information and/or protection; to protect consumers against health hazards. Separate provisions on the content of instructions for use are also contained in product-specific legislation at EU level. Otherwise, assessing the need for such labelling is the duty of the operator, as the operator is responsible for ensuring the safety of the food it has produced and processed. Furthermore, the Finnish Food Safety Authority Evira considers that certain foodstuffs, described below, must be equipped with specific warning text/instructions for use.

The labelling must be located in a conspicuous place using clear and sufficiently large lettering so that the labelling is easy to read and understand. If a consumer with normal eyesight is unable to notice and read the warning text/instructions for use with ease, the packaging labelling of the product is in violation of the provisions.