Key Benefits:
Announcing on the addition of certain substances other than vitamins and minerals to foodstuffs 1)
In accordance with section 7 9, section 37 and section 60 (2), Three, in the law. 526 of 24. June 2005 on food, cf. Law Order no. 820 of 1. July 2011 :
Scope and definitions
§ 1. This notice includes the addition of food, including food supplements, of the following substances :
1) substances which are not vitamins or minerals, which have and / or are added to have a nutritional or physiological effect, and
2) flavourings and food additives, which, in addition to being added as aroma or food additive, also have and / or are added for the purpose of having a nutritional or physiological effect.
Paragraph 2. This notice shall apply only where specific provisions are not provided for in :
1) nutrients,
2) novel foods and new food ingredients (novel food),
3) food for particular nutrients,
4) food additives ;
5) flavouring,
6) genetically modified food,
7) trade standards and marketing standards.
Paragraph 3. Food and substances referred to in paragraph 1. 2 may be used in accordance with the relevant specific legislation.
Paragraph 4. This notice shall not apply to :
1) planting stock in fresh, dried, chopped, cut or pulverised form, and
2) the extracts of planting stock, which have been obtained solely by overpouring with boiling water (an infus).
§ 2. For the purposes of this notice :
1) ' Substances ` means substances which have a nutritional or physiological effect and which :
a) are not vitamins or minerals ;
b) where food is added to the purpose of obtaining a nutritional or physiological effect,
c) has a purity of at least 50% or is concentrated 40 times or more, and
d) generally not be taken as a food in itself and normally is not used as a typical ingredient in food.
2) ' Aroma ` shall mean the aroma of flavourings, flavouring flavouring, reaction flavour, flavouring flavour, flavouring flavouring, flavouring substances or mixtures of these other or other additives or food.
3) ' Aromatised beverages ` means : non-alcoholic beverages added to the flavouring ingredient or substance.
4) 'Sports products' means food for consumption in the case of highly demanding muscle work, especially for sports people, which are covered by the notice of particular nutrients.
5) ' Food additive ` means a reference to the definition in Regulation (EC) No 2 of the European Parliament and of the Council. 1333/2008 of 16. In December 2008 on food additives.
Conditions for use
§ 3. In the case of substances covered by the notice, only the substances covered by Annex 1 are added to food, including food supplements, under the conditions laid down in the Annex. however, paragraph 1 2.
k. 2 The maximum quantities set out in the Annex must not be exceeded regardless of the source of the substance or the purpose of the condition, unless otherwise specified for the substance concerned.
Paragraph 3. For substances covered by paragraph 1. 1, the requirements for identity and purity laid down in the specifications set out in Annex 2 shall apply.
§ 4. Substances covered by Annex 1 and which are intended to be added to other conditions other than those listed in the Annex may be applied for a period of six months after the condition is notified to the Food Authority.
Paragraph 2. The notification, cf. paragraph 1, shall contain the information contained in Annex 3 (I). The notification shall relate to the addition of the substance to the product concerned. A notification shall not be deemed to have been filed until all the information has been submitted to the Food Authority.
Paragraph 3. In cases where data has already been submitted and subsequently assessed and approved in another Member State, and this assessment has been submitted to the Food Authority, they may be able to do so in paragraph 1. However, 1 mentioned substances shall be taken for three months after notification to the Food Authority, cf. however, paragraph 1 4.
Paragraph 4. If there are reasons for this, the Food Service may extend it in paragraph 1. 3 mentioned period to 6 months.
Paragraph 5. It is a prerequisite for the application of paragraph 1. 1 4, that the FDA has not been banned from the notified use of the substance prior to having been banned.
Paragraph 6. Regardless of the fact that the Food Authority does not, in the context of the notification, have been banned from a substance covered by paragraph 1. 1, the FDA may later lay down the prohibition of use if the conditions are to be used for this purpose.
Paragraph 7. The Food Management Board may lay down conditions for the use of the substance, including the use only for a limited period, or that the substance may only be used in certain food categories.
Paragraph 8. A notified substance shall be used only in accordance with the information in the notification.
§ 5. The provisions of section 4 shall also apply to amino acids, which are not covered by Annex 1 but which satisfy the requirements for identity and purity specified in the specifications in Annex 2.
§ 6. Addition of substances not covered by Section 5 or Annex 1 shall be approved by the Food Authority.
Paragraph 2. The application for approval, cf. paragraph 1 shall include the information contained in Annex 3 (II). An application shall not be deemed to have been filed until all the information has been submitted to the Food Authority.
Paragraph 3. The Food Management Board may lay down conditions for the use of the substance, including the use only for a limited period, or that the substance may only be used in certain food categories.
Paragraph 4. The Food Safety Management Board shall decide on applications for approval no later than six months after receipt of the application, but not later than three months after the submission of the data already authorised in another Member State, cf. however, paragraph 1 5.
Paragraph 5. If there are reasons for this, the Food Service may extend it in paragraph 1. 4 mentioned period to 6 months.
§ 7. At the latest with the marketing of food added to substances covered by Annex 1, the producer, importers or others responsible for the first marketing in Denmark shall send a copy of the marking to be used for the first marketing year, The FDA.
Paragraph 2. Changes to the labelling applied and the withdrawal of the food from the market must be communicated to the Food Authority.
Paragraph 3. Paragy1 and 2 shall not apply to food supplements.
§ 8. The manufacturer or importer responsible for the first marketing in Denmark of a foodstuff containing added substances must comply with the additional own checks provided for in Appendix 4 in addition to the general rules on self-monitoring.
Penalty provisions
§ 9. Regulation (EC) No, Regulation (EC) No, 764/2008 of 9. July 2008 laying down procedures for the application of certain national technical regulations to products placed on the market legally in another Member State, and repealing Decision No 2 of the Commission. Regulation 3052 /95/EC shall apply to administration of the notice.
§ 10. Immediately after completed case processing, the FDA is updating Annexes 1 and 2 with
1) substances that have been applied in accordance with section 4 (4). 1-5, and
2) substances approved in accordance with section 6 (1). 1, cf. paragraph 3.
§ 11. The penalty shall be penalised by the penalty which is in breach of section 3, section 4. 1, 5 or 8, section 5, section 6 (4). Paragraph 7, paragraph 7. 1 or 2, or Article 8, or conditions set pursuant to section 4 (4). 7, or Section 6 (4). 3, in this notice.
Paragraph 2. The sentence may rise to a maximum sentence for two years if it has been committed by the action or omission, with a set of or gross negligence, and there is a breach in the infringement proceedings ;
1) damage to health or to the detriment of such risks ; or
2) obtained or intended to benefit from the economic advantage of the person concerned himself or others.
Paragraph 3. Companies can be imposed on companies, etc. (legal persons) punishable by the rules of the penal code 5. Chapter.
Entry into force
§ 12. The announcement shall enter into force on 16. August, 2011.
Paragraph 2. Food supplements placed on the market before the 161. 1 August 2011 and which do not comply with the provisions of this notice and for which no later than 16. November 2011 has been filed notification of added substances, cf. Section 4 (4). 1, or the application for approval of added substances, cf. Section 6 may be placed on the market while the matter is being processed in the Food Authority.
Paragraph 3. Food that goes before the 16th. August 2011 has been made in accordance with section 14-16, cf. Annex 3, in the notice of publication no. 93 of 4. In February 2011, on the addition of herds, etc. for food, must be placed on the market until the stocks are used.
The FDA, the 12th. August, 2011
Esben Eoked Rasmussen
/ Anette Flensborg
Appendix 1
Certain other substances other than vitamins and minerals authorised in food, including food supplements ;
The quantities specified in the Annex must not be exceeded regardless of the source or the purpose of the condition, unless otherwise specified for the substance in question.
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Appendix 2
Characteristics of identity and purity and analytical methods
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Appendix 3
I. The notification, cf. Section 4 (4). 2, must include the following information :
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II. Applications for approval, cf. Section 6 (2). 2, must include the following information :
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Appendix 4
Additional self-control provisions
1) The company must be able to document the declared amount of the added substance. The samples must be taken of the food for the analytical control of the substances that have been added. The controls must be carried out on the guidelines laid down in paragraph 1. 2-4. In addition, the time required for food supplements must be carried out from the guidelines laid down in paragraph 1. 5.
2) For foodstuffs containing up to five added substances, the content of each substance shall be analysed at least once a year. For foodstuffs containing 6-10 added substances, the content of each substance must be analysed at least once every 2. Years. The analyses must be carried out so that at least once a year, at least one substance is produced in the product. For foodstuffs containing more than 10 added substances, the content of each substance must be analysed at least once every 3. Years. The analyses must be carried out so that at least once a year, at least one substance is produced in the product.
3) Analytically determined total content (natural + added), added or deducted from the analytical uncertainty calculated as 95% confidensinterval, must be between 80 and 150% of the declared content.
4) Where a maximum level is specified in Annex 1 for a substance, the analyzed content of the substance shall comply with this maximum value.
5) Co-supplements that are not chew tablets, shower tablets, suction tablets, "slows release" tablets or similar, must, in addition to the analysis after paragraph 1. 1, also undergoing measurement for the period of time. The waste time shall not exceed 60 minutes.
6) In the case of imports of foodstuffs from other Member States of the European Union, the analytical control after paragraph 1 may be suspended if the undertaking can substantiate the fact that a check has been carried out in the notification country with a view to ensuring the same security as regards their compliance with the purposes of the control.
1) The announcement has been notified to the Directive 98 /34/EC of the European Parliament and of the Council of Directive 98 /34/EC (Directive 98 /48/EC), as amended by Regulation (EC) No 1925/2006 of 20. In December 2006, on the addition of vitamins and minerals, as well as certain other substances to food.
