Article 21 labeling of allergenic substances

Article 21 is the main article for handling the labeling of substances or products that cause allergies or intolerances, and is structured in two sections:

Paragraph 21.1: Indicates how the labeling of certain substances or products causing allergies or intolerances should be presented. The mandatory statements referred to in Article 9.1 (c), without detriment to the rules adopted in Article 44.2, must comply with the following requirements:

• Adopting the measures and requirements described in the following subsections, operators of food entities shall mention on the product, the substances present that may cause allergies or intolerances in consumers.

• With regard to the form of expression and presentation on unpackaged products of the allergenic substances which must be mentioned, the member states shall take internal measures which shall prevail over the rules contained in Article 21.

• These allergenic substances shall be indicated in the list of ingredients in accordance with the rules stipulated in article 18.1, and the name of the substance or product shall be clearly mentioned in correspondence with the contents of annex ii.

• According to annex ii of the European regulation, ingredients, products or derivatives of substances that cause allergies or intolerances must be clearly mentioned in the list of ingredients of the product, referring to the name of the substance as it appears in the said annex. This measure does not modify what was previously stipulated in Directive 2000/13/EC.

• The names of substances or products contained in annex ii shall be highlighted in the typesetting so that they can be clearly distinguished from the other substances in the list of ingredients, such as through font type, style or background color.

• The use of "bold" typeface is a very effective way to highlight the allergenic substance from the other substances in the ingredient list.

• Operators may, for technical reasons, use other ways or means of highlighting the allergenic substances of mandatory mention in addition to what is specified in the provision on font type, style, etc.

• The description of the statements referred to in Article 9.1(c) shall include the word "contains" + the name of the allergenic substance as listed in Annex ii, in those cases where there is no listing of product ingredients, such as on reusable glass bottles that have permanent markings and do not require labels.

• For each ingredient and technological adjuvant, information on its composition must be indicated on the product label, when they are derived from a single allergenic substance or product of those contained in Annex II.

In this case the operator, for each ingredient or processing aid present in the food product, which is derived from an allergenic substance causing allergic reactions or intolerances, may refer to the allergenic substance multiple times or may choose a form of presentation where it indicates that the ingredients or processing aids are derived from a single allergenic substance.

The operator is not obliged to label substances or products that cause allergies or intolerances when the name of the food clearly refers to the name of the substance, such as wheat flour, tuna pate, strawberry-flavored soy beverages (if soy lecithin is used in the flavor) or dairy products such as yogurt, cheese, etc., since it is understood that they are derived from milk.In addition, when the name of the ingredient clearly refers to the substance or product causing allergies or intolerance, the labeling of the substance or product involved is also not mandatory. As stipulated in Articles 9.1 (a) an