Practical comments on fortified foods, NANDO system and introducing dietary supplements on the market

Publication date: January 09, 2025

Dictionary:

• Fortified foods – these are food products that have had additional nutrients added (such as vitamins, minerals, fiber) to improve their nutritional value and prevent deficiencies of these nutrients in the diet, e.g. enriching spring water with minerals changes the qualification of this water to mineral water.
• NANDO – (New Approach Notified and Designated Organisations) notification is the act by which a Member State informs the Commission and the other Member States that a body that meets the relevant requirements has been designated to carry out conformity assessments in accordance with the directives. Notification of notified bodies and their withdrawal are the responsibility of the notifying Member State.

Bodies notified:

1. are free to offer their conformity assessment services to any economic operator in the EU and beyond
2. may conduct this activity in the territory of other EU Member States or non-EU countries
3. must act in a non-discriminatory, transparent, neutral, independent and impartial manner
4. must employ the necessary personnel with sufficient knowledge and experience to carry out the conformity assessment in accordance with the relevant legal provisions
5. must take appropriate measures to ensure the confidentiality of information obtained during the conformity assessment
6. must have appropriate insurance covering their professional activities, unless liability is ensured under the national law of the notifying EU Member State
7. must provide information to their notifying authority, market surveillance authorities and other notified bodies
8. Manufacturers are free to choose any notified body that is legally designated to carry out the conformity assessment procedure.

• Food certification companies – this should be understood as conformity assessment bodies demonstrating that a properly identified product, product design or its manufacturing process complies with the requirements;
• Dietary supplement – is a food product whose purpose is to supplement a normal diet, being a concentrated source of vitamins or minerals or other substances with a nutritional or other physiological effect, single or complex, introduced to the market in a form enabling dosing.

Does a company that evaluates fortified food products have to be in some register?

Yes, a company assessing food products must be accredited by the PCA (Polish Center for Accreditation). The Polish Center for Accreditation is a national accreditation body authorized to accredit conformity assessment bodies under the Act of 13 April 2016 on conformity assessment and market surveillance systems. A company assessing food products is required to receive accreditation under Article 22 of the Act of 13 April 2016 on conformity assessment and market surveillance systems (Journal of Laws of 2022, item 1854, as amended).

To obtain accreditation, an application must be submitted to the PCA pursuant to Article 23 of the aforementioned Act. Such an application should include:

1) the name of the conformity assessment body applying for accreditation and the address of its registered office;

2) the number in the register appropriate to the conformity assessment body;

3) defining the scope of accreditation;

4) a list of documents describing the management system in the conformity assessment body (originals or copies certified by persons authorized to represent the conformity assessment body must be submitted).

The application may be submitted in paper or electronic form; if submitted electronically, it must be accompanied by a qualified electronic signature.

The PCA considers the application for accreditation within a period not longer than 12 months from the date of submission of the application. The absence of any of the above elements does not result in the commencement of the 12-month period. In the event of a refusal to grant, withdrawal, suspension or limitation of the scope of accreditation, an appeal may be lodged with the PCA Appeal Committee within 14 days from the date of receipt of the notification of granting, withdrawal, suspension or limitation of the scope of accreditation. After the Appeal Committee considers the appeal, the body shall refer the case to the PCA for reconsideration in the event of the appeal being justified or shall dismiss the appeal, in which case a complaint against the appeal may be lodged with the Voivodship Administrative Court through the Appeal Committee within 30 days from the date of receipt of the notification.

Why are food certification companies not notified bodies in the NANDO database?

Food certification companies are not notified bodies in the NANDO database, because NANDO notifies bodies only when they assess the compliance of products with regulations that require special EU regulations, such as product safety, labeling, or assessment of conformity under specific EU directives. Food certification, e.g. in terms of quality, can be performed by companies that do not have to meet such requirements, because they are not subject to special regulations regarding notification in the NANDO system.[1]

The organisation to be designated must meet detailed requirements regarding organisational aspects, quality management, resources and processes. These requirements are verified by the national authorities responsible for notified bodies with the participation of other European experts.[2]

A notified body is a conformity assessment body, reported to the European Commission and placed on the list of notified bodies for specific directives. Such a body has a unique identification number. A notified body is authorized to conduct conformity assessment and issue type conformity certificates. A manufacturer whose product must undergo conformity assessment involving a third party must use the services of a notified body of their choice.

What is the legal environment for introducing dietary supplements to the Polish market?

In accordance with the applicable legal status, three separate registration systems are currently operated in the territory of the Republic of Poland:

1) medicines,

2) dietary supplements,

3) cosmetics.

All three areas are subject to the Minister of Health, who controls their functioning through the appropriate bodies:

– President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,

– Chief Sanitary Inspector,

– Institute of Occupational Medicine – register of cosmetics in the National Cosmetics Information System.

To introduce a dietary supplement to the market in Poland for the first time, the following steps must be taken:

• Notify the Chief Sanitary Inspector. This notification must include:

1) the name of the product and its manufacturer;

2) the form in which the product is introduced to the market;

3) model labelling in Polish;

4) the classification/type of foodstuff adopted by the food market entity;

5) qualitative composition including data on the ingredients contained in the product, including active substances;

6) quantitative composition of ingredients;

7) name and surname or name, address and tax identification number (NIP) of the entity notifying about the first introduction to the market.

• The Chief Sanitary Inspectorate may conduct proceedings aimed at explaining the product’s properties. The Chief Sanitary Inspector may request the submission of an opinion from the appropriate research and development unit. This opinion is taken into account in this proceeding.

Chief Sanitary Inspector may also require the entity to document that the food product meets the requirements for a given type of food product. The explanatory proceedings may not last longer than 60 days. It should also be noted that in the event of suspicion that the food product does not meet the requirements specified for that product, the relevant sanitary inspector shall decide to suspend the introduction of that food product to the market or to withdraw it from the market until the explanatory proceedings are completed.[3]

When introducing a dietary supplement to the market, it is worth using advertising. The issue of advertising is addressed in many legal regulations. They state that a manufacturer of dietary supplements, in addition to the usual statutory advertising prohibitions, cannot manipulate information regarding the labeling of a food, in particular regarding the characteristics of the food, including its name, type, properties, composition, quantity, durability, source or place of origin, methods of production or manufacturing (Article 46, paragraph 1, point 1, letter a), by:

• attributing to a food an effect or property that it does not possess (Article 46 paragraph 1 point 1 letter b),
• suggesting that a food has special properties if all similar foodstuffs have such properties (Article 46(1)(1)(c)),
• attributing to a food the property of preventing or treating diseases or referring to such properties, subject to the provisions of the Act (Article 46, paragraph 1, point 2).

The provisions of Article 46 paragraph 1 also apply to the advertising and presentation of foodstuffs, in particular in relation to their shape, the appearance of the packaging, the packaging materials used, the method of presentation and the environment in which they are presented (Article 46 paragraph 2).

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[1]https://webgate.ec.europa.eu/single-market-compliance-space/home

[2]https://single-market-economy.ec.europa.eu/single-market/goods/building-blocks/notified-bodies_en

[3]Act of 25 August 2006 on food and nutrition safety (Journal of Laws of 2023, item 1448).