Source: http://www.bmel.de/EN/Food/Safe-Food/_Texte/Supplements-Operators.html?nn=522306
Timestamp: 2017-10-22 04:18:51
Document Index: 321380437

Matched Legal Cases: ['§ 1', '§ 12', '§ 5', '§ 5', '§ 4', '§ 5', '§ 54', '§ 7', '§ 7', '§ 54', '§11', '§ 12']

BMEL - Safe food - Food supplements: answers to frequently asked questions by food operators
What are food supplements? What is the difference between food supplements and medicinal products? These are just some of the questions answered here
3. Who is in charge of a food supplement's marketability?
4. What do producers or importers need to consider when wanting to place food supplements on the market?
5. What is compulsory notification?
6. How must a food supplement be labelled?
7. What else do I need to observe when a given food supplement is already marketed in another member state?
8. Which transitional arrangements apply for vitamins and minerals not listed in the Ordinance on Food Supplements (Verordnung über Nahrungsergänzungsmittel) in Germany until the end of 2009?
9. What do I have to consider when advertising food supplements?
10. Who controls the compliance with food law provisions?
11. Which substances may be added to food supplements?
12. Are there maximum levels for nutrients in food supplements?
13. What do I have to consider when I want to use a new food ingredient in a food supplement?
According to § 1 of the Ordinance on Food Supplements (Verordnung über Nahrungsergänzungsmittel, NemV), food supplements are foodstuffs
Food supplements are foodstuffs. Therefore, they are subject to the relevant food law provisions. Foodstuffs means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. The complete definition can be found under Article 2 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council of 28. January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.
Medicinal products are intended to heal, alleviate, prevent or identify diseases, suffering, physical defects or health disorders, or to influence the condition, state or function of the body or the mental state. They are governed by the provisions of the Medicinal Products Act (Arzneimittelgesetz). Medicinal products are marketable only after being authorised or if a marketing authorisation has been granted by the Commission of the European Community or by the Council of the European Union in accordance with Regulation (EC) No. 726/2004 Article 3(1) or (2) of the European Parliament and the Council from 31. 03. 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the evaluation of medicinal products (Official Journal of the EU No. L 136 page 1). Products authorised as medicinal products may not be marketed as foodstuffs.
Accordingly, food supplements must not be labelled as medicinal products or be advertised with claims relating to healing, alleviating or preventing diseases. (Prohibition of disease-related advertisement, cf. also § 12 Food and Feed Act (Lebensmittel - und Futtermittelgesetzbuch, LFGB).
The manufacturer or foodbusiness operator has to ensure compliance with food law provisions.
To assess whether a product that is to be placed on the German market complies with applicable legal provisions, it is recommended to consult an officially appointed and sworn food expert (commercial chemist). A list of experts with contact information is available from the website of the Chamber of Commerce and Industry (Industrie- und Handelskammer, IHK) (special field no. 5150 or 5200) or as a leaflet entitled "Geprobt und Geprüft - Lebensmittelsachverständige" from the Chamber of Industry and Commerce, Fasanenstrasse. 85, 10623 Berlin (www.ihk.de).
In the Federal Republic of Germany, it is within the responsibility of the Länder to monitor compliance with food law provisions.
Import and placing on the market of foodstuffs are regulated by the general food law provisions and a few specific legal provisions. Please refer in particular to the provisions of the Food and Feed Act (Lebensmittel - und Futtermittelgesetzbuch,LFGB)4, according to which foodstuffs may be produced and placed on the market only if they comply with applicable food law provisions. The Ordinance on Food Supplements (Verordnung über Nahrungsergänzungsmittel) is also of importance; this Ordinance has transposed the provisions of the Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements into German law.
For questions on the assessment of marketability, please refer to question no. 3.
For questions about compulsory notification, please refer to question no. 5.
For food supplements which are already legally marketed in other EU member states, please refer to question no. 7.
For transitional arrangements, please refer to question no. 8.
Germany has a compulsory notification scheme for foodstuffs, as laid down in § 5 of the Ordinance on Food Supplements (Verordnung über Nahrungsergänzungsmittel). However, such notification does not release food operators from their responsibility to comply with food law provisions, the monitoring of which is within the responsibility of the individual Länder.
If a manufacturer or importer wants to introduce a food supplement on the German market, they must notify the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL) no later then at the moment of initial marketing by providing a sample of the label used on the product. Such notification is required also when a food supplement has already been notified for marketing and placed on the market in another EU member state. Please refer to the website of the Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) for further information about the notification procedure. The notification form pursuant to § 5 of the Ordinance on Food Supplements (Verordnung über Nahrungsergänzungsmittel) is available for download here.
The labelling of food supplements is laid down in § 4 of the Ordinance on Food Supplements (Verordnung über Nahrungsergänzungsmittel). In addition to the information required by the Food Labelling Ordinance (Lebensmittel-Kennzeichnungsverordnung, LMKV), the following must be included on the label:
any pre-packaged good must contain the description "food supplement" as sales description in accordance with the Food Labelling Ordinance (Lebensmittel-Kennzeichnungsverordnung, LMKV),
information about the category of nutrient,
information about the amount of nutrient in relation to the recommended daily consumption and information about the percentage in relation to the nutrient reference value,
the warning: "Do not exceed the stated recommended daily dose",
a statement to the effect that food supplements should not be used as a substitute for a balanced and varied diet, and
a statement to the effect that the products should be stored out of the reach of children.
Advertising, labelling or presentation of a food supplement must not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.
For information about the prohibition of disease-related advertisement, please refer to question no. 2.
According to § 5 of the Ordinance on Food Supplements (Verordnung über Nahrungsergänzungsmittel), notification is also required when a food supplement has already been notified for marketing and placed on the market in another EU member state.
If a product which is already legally marketed in another EU member state is to be placed on the German market, but does not comply with the Federal Republic’s food law provisions, for example if it contains added substances that are treated in the same way as additives but are not authorised in Germany, it is possible to issue a general decree under § 54 of the Food and Feed Code (Lebensmittel- und Futtermittelgesetzbuch, LFGB4 ). Such a general decree will only be issued if there are no compelling reasons of public health that oppose the issuance. The corresponding applications are to be addressed to the
Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL)
For further information about the application procedure, please also refer to www.bvl.bund.de.
For vitamin and mineral compounds which are already authorised for use by exemption permits and general decrees, these authorisations continue to apply provided that this is not contrary to the provisions of Directive 2002/46/EC of the European Parliament and of the Council of 10. June 2002 on the approximation of the laws of the Member States relating to food supplements (OJ No L 183, p. 51).
For information about the compulsory notification, please refer to question 5.
Pursuant to Article 4 (6) of Directive 2002/46/EC10, member states may under certain conditions allow in their territory the use of vitamins and minerals not listed in Annex I, or of vitamins and minerals in forms not listed in Annex II until 31. December 2009. These rules have been transposed into German law through § 7 (2) of the Ordinance on Food Supplements (Verordnung über Nahrungsergänzungsmittel).
A list of vitamin and mineral compounds pursuant to the first sentence no. 2 of § 7 (2) of the Ordinance on Food Supplements (Verordnung über Nahrungsergänzungsmittel).) was published in the Federal Gazette No. 24 of 4. February 2006 (page 752). However, the publication of the list of these substances does not mean that it is generally allowed to use these substances in food supplements and to place food supplements produced in this manner on the market.
An exemption permit under Section 68 of the Food and Feed Act (Lebensmittel- und Futtermittelgesetzbuch, LFGB) or a general decree under § 54 of the Food and Feed Code is required for the production and placing on the market of food supplements containing substances that had not already been allowed prior to 28. May 2004 as food additives for nutritional purposes to be incorporated into food supplements. The latter may be considered if the food supplement in question is legally marketed in a different EU member state (see question no. 7).
Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20. December 2006 on nutrition and health claims made on foods has been applicable since July 2007 and is available on the internet. Transitional measures under Article 28 must be complied with.
According to §11 of the Food and Feed Code (Lebensmittel- und Futtermittelgesetzbuch, LFGB) 4), it is prohibited to commercially market foodstuffs using misleading labels, claims or presentations or to advertise foodstuffs generally or in individual cases using misleading presentations or claims. A clear example of misleading consumers is when foodstuffs are said to have certain effects which are not sufficiently proven by scientists.
According to § 12 of the Food and Feed Code (Lebensmittel- und Futtermittelgesetzbuch, LFGB) 4, food supplements must not be advertised with claims relating to the healing, alleviating or preventing of diseases.
Food supplements are not medicinal products and may not be advertised as such. For more information about the difference between foodstuffs and medicinal products, please refer to question no. 2.
Compliance with food law provisions is monitored by the competent authorities of the Länder. If, after the purchase of a food supplement, consumers have reasonable doubt about its labelling and composition, they may turn to the local competent food supervisory authority (usually the regulatory agency) or to the supreme authority responsible for food monitoring in the Land. An overview of the competent Ministries/Senate Departments of the Länder is available on the website of the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL).
The permitted vitamin and mineral compounds are laid down in Directive 2006/46/EC10 and the Ordinance on Food Supplements (Verordnung über Nahrungsergänzungsmittel). On this basis, only the addition of vitamins and minerals in food supplements are currently regulated; the Ordinance does not cover other substances such as amino acids, essential fatty acids and plant and herb extracts. Products containing such substances must be verified on a case-by-case basis to see whether they comply with the general legal provisions. In Germany, certain substances used for nutritional purposes are treated in the same way as additives. This means they are subject to authorisation for the use in food supplements and other foods..
For maximum levels, please refer to question no. 12.
Directive 2002/46/EC10 and correspondingly the Ordinance on Food Supplements (Verordnung über Nahrungsergänzungsmittel) contains a list of vitamin and mineral compounds permitted in food supplements. However, they do not regulate the amounts allowed to be added. It is planned to regulate maximum levels for vitamins and minerals in food supplements at European level, a process that has not yet been concluded. Maximum levels are necessary for the protection of consumer health due to a lack of knowledge about possible side effects of large-dose intake of vitamins and because excessive supply of vitamins and minerals may have adverse health effects.
The European Food Safety Authority (EFSA) has compiled risk assessments required for setting maximum levels. The EFSA has set "Tolerable Upper Intake Levels" (UL) for 16 vitamins and minerals relating to maximum levels.
These UL-values are not to be confused with maximum levels for foodstuffs. UL-values are rather safe maximum levels for a life-long, daily intake of vitamins and minerals from all available sources such as conventional foodstuffs, enriched products and vitamin and mineral preparations. A maximum level, on the other hand, indicates what amount of a vitamin or mineral may be added to a food supplement.
In July 2006 the European Commission published a consultation paper on the setting of maximum and minimum levels of vitamins and minerals. You can find the responses of parties involved on the internet. Until the planned rules on maximum level come into force under Community law, it has to be decided on a case-by-case basis whether a specific product corresponds to the applicable food law provisions.
In Germany, the Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, BfR) has reassessed the issue of vitamins and minerals in foodstuffs and put forward proposals for maximum levels of vitamins and minerals in food supplements.
According to Regulation (EC) No 258/97 of the European Parliament and of the Council of 27.. January 1997 concerning novel foods and novel food ingredients, novel foods and novel food ingredients are foods and food ingredients which have not been used for human consumption to a significant degree within the European Union prior to 15. May 1997 (date of the coming into force of the regulation) and which fall under specific categories listed in the said regulation.
Novel foods and food ingredients may be released on the market within the European Union only after they have been granted a corresponding authorisation following a health assessment.
If a food business operator intends to use a novel food ingredient in food supplements, the operator responsible for placing the product on the EU market must file the corresponding application with the competent authorities of the member state in which the product is to be initially released to the market. In Germany, such applications are to be sent to the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL) . Detailed information about authorisation procedures and the required application dossier can also be found in Regulation (EC) No 258/97 and the Commission Recommendation of 20. July 1997.