In-house control of food supplements

In-house control (referred to as ‘own checks’ in the Food Act) requires operators to have sufficient and correct information on the food supplements that they produce, manufacture, import, export, package, sell, serve or distribute as foods. Products must be safe and must not mislead the consumer.

In-house control of food supplements should include at least the following:

Composition:

  • ingredients and finished food supplements are of good microbiological quality,
  • food supplements and their ingredients do not contain alien substances in quantities that exceed threshold values (environmental toxins, heavy metals, mould toxins, etc.),
  • food supplements only contain vitamins and/or minerals allowed in the Commission Regulation (EC) No 1170/2009, and only in the allowed chemical compounds,
  • ingredients do not contain hormones or doping substances,
  • permitted quantities of permitted additives are not exceeded.
  • regarding the composition, pay attention to the more susceptible consumer groups (for example in food supplements for children)

Novel foods
The food supplement does not contain novel food ingredients that have not been authorised in EU. Novel foods refer to products, which have not prior to May 1997 been used for human consumption to a significant degree within the Community. Regulation (EC) 258/97 applies to novel foods. 

Medicinal product – food supplement
Food supplements must not contain medicinal products as referred to in section 3 of the Medicines Act 395/87. If a food supplement contains substances listed in the List of Medicines or large doses of vitamins and/or minerals, it is recommended that a classification be requested from the Finnish Medicines Agency Fimea (former National Agency for Medicines).

Organic
If food supplements are sold as organic products (organic, biodynamic, eco, etc.), the product must fulfil the requirements of the EU Regulation on organic production, and the labelling must show that the product comes under organic control, i.e. the emblem of the organic controller.

Genetic modification
Any genetically modified organisms used in the production of the food and ingredients of the food manufactured from such organisms are indicated on labelling and traceability has been ensured (Regulations (EC) 1829/2003 and (EC) 1830/2003).

Irradiation
Any irradiation of dried spice herbs, spices and spice plants must be declared on the labelling in accordance with regulations. (Note that the irradiation of any other ingredients is not allowed, under the Decree of the Ministry of Trade and Industry on Treatment of Food with Ionizing Radiation, 852/2000).

Package labelling:

  • is in Finnish and Swedish,
  • is easily visible and readable,
  • is consistent with the composition of the contents,
  • indicates the necessary limitations on use and warnings.

Marketing
Marketing must conform to regulations (for instance, no medical claims may be used on the packaging or in other marketing, and any claims made regarding the product must be truthful). Marketing must also conform to the requirements of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods, and permission has been sought for the claims used in marketing. The Commission is estimated to publish the list of permitted nutrition claims by the end of 2011, and after this only the permitted claims may be used. New claims must be submitted for approval before they may be used. However, there is no transition period for claims of reducing the risk of illness. Claims regarding the health and development of children have been subject to permit since January 2008, and the date of the decision determines the transition period for their use. For more information, see the pages on nutrition and health claims at the Evira website.

Traceability
An operator in the food business must know and keep records of where each food supplement or ingredient thereof has been purchased and to whom the food supplement has been sold (traceability requirement as per the general EU Food Regulation 178/2002).

Withdrawals and notifications of injurious effect
The in-house control plan must include procedures for any product withdrawals or notifications of injurious effect required.

Notification of changes
The food supplement notification submitted to the Food Safety Authority must be up to date. A new notification must be submitted whenever the composition of a product changes or a food supplement is withdrawn from the market.

The compliance of products with regulations may be monitored in in-house control through means such as certificates from ingredient providers, inspections and/or in-house sampling and tests.

The Food Act (23/2006) provides for the in-house control plan (referred to in the Act as the ‘own-check plan’, sections 19-20). The requirement for in-house control and the drawing up of the in-house control plan applies to all operators in the food sector — importers, manufacturers and marketers — with a small number of exceptions. Local food safety authorities monitor that in-house control plans cover the ensuring of compliance of food supplements with regulations in sufficient detail at all stages of the product process and that the plan is also being implemented in practice.

Useful links:

Evira’s web page www.evira.fi and European commission’s web page www.europa.eu and
Web page of Finnish Medicines Agency www.fimea.fi

Food supplements
www.evira.fi – In English – Food – Manufacture and sales
Direct link: https://www.evira.fi/en/foodstuff/manufacture-and-sales/food-categories/food-supplements/
Food supplement guide https://www.evira.fi/en/about-evira/publications/food/oppaat/   http://ec.europa.eu/food/index_en.htm   Food and Feed Safety – Labelling and nutrition – food supplements
Direct link: http://ec.europa.eu/food/food/labellingnutrition/supplements/index_en.htm .

http://www.fimea.fi/web/en/frontpage (Finnish Medicines Agency) – License holders – Classification
Direct link: http://www.fimea.fi/web/en/supervision/classification

Novel Foods
www.evira.fi – In English – Food – Manufacture and sales
Direct link: https://www.evira.fi/en/foodstuff/manufacture-and-sales/common-requirements-for-composition/novel-foods/

http://ec.europa.eu/food/index_en.htm – Food and Feed Safety – Novel Food
Direct link: http://ec.europa.eu/food/food/biotechnology/novelfood/index_en.htm

The Novel Food Catalogue, where products or other ingredients of plant or animal origin are classified, based on the information available on their history of use http://ec.europa.eu/food/food/biotechnology/novelfood/nfnetweb/index.cfm

Organic farming
www.evira.fi – In English – Themes – Organic production
https://www.evira.fi/en/shared-topics/organic-production/

http://ec.europa.eu/agriculture/index_en.htm – Policy areas – Organic Farming
Direct link: http://ec.europa.eu/agriculture/organic/home_en

GM Food and Feed
www.evira.fi – In English – Food – Manufacture and sales- Production practices
https://www.evira.fi/en/foodstuff/manufacture-and-sales/common-requirements-for-composition/genetically-modified-food-gmo/

http://ec.europa.eu/food/index_en.htm – Gm Food and Feed
Direct link: http://ec.europa.eu/food/food/biotechnology/gmfood/index_en.htm

Irradiation
http://ec.europa.eu/food/index_en.htm – Food and Feed Safety – Biological Safety – Irradiation
Direct link: http://ec.europa.eu/food/food/biosafety/irradiation/index_en.htm

Labelling
www.evira.fi – In English – Food – Manufacture and sales – Labelling
Direct link: https://www.evira.fi/en/foodstuff/manufacture-and-sales/food-information/labelling/

www.europa.eu/food  Food and Feed Safety – Labelling and nutrition – Food labelling
Direct link: http://ec.europa.eu/food/food/labellingnutrition/foodlabelling/index_en.htm

Health and nutrition claims
www.evira.fi – In English – Food – Manufacture and sales – Labelling
https://www.evira.fi/en/foodstuff/manufacture-and-sales/food-information/nutrition-and-health-claims/

http://ec.europa.eu/food/index_en.htm - Food and Feed Safety - Labelling and nutrition – Health and nutrition claims
Direct link: http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm

Guidelines on withdrawal of products
www.evira.fi – In English – Food – Manufacture and sales
Direct link: https://www.evira.fi/en/foodstuff/manufacture-and-sales/control/guidelines-on-withdrawal-of-products/

Legislation
Finnish legislation www.finlex.fi 
EU-legislation: www.eur-lex.europa.eu