Food Standards Agency
Thursday 24 July 2008
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The Food Supplements Directive 2002/46/EC came into force in July 2002 and was implemented in England by the (External) Food Supplements (England) Regulations 2003 . Separate, equivalent legislation has been made in Scotland, Wales and Northern Ireland. The directive and these regulations have applied in full since 1 August 2005.
One of the provisions of this directive is for lists of nutrients and their sources that can be included in food supplements. The first list covers the vitamins and minerals that may be used in food supplements (such as vitamin C, calcium, iron). It excludes six minerals (tin, silicon, nickel, boron, cobalt, and vanadium) that are currently used in food supplements on sale in the UK.
The second list covers the chemical forms (sources) of those vitamins and minerals that may be used. These lists can be added to following a favourable opinion on individual nutrients or nutrient sources from the European Food Safety Authority (EFSA) after consideration of a dossier containing safety data.
Only one dossier is required per nutrient substance for assessment by EFSA, therefore it is possible for manufacturers to collaborate and provide a dossier for assessment with information collated from a number of sources. Manufacturers are not required to submit dossiers for individual products or for an individual operator’s use of a substance.
Where dossiers were submitted before 12 July 2005, a derogation will apply in the UK for the nutrient substances listed on the (External) European Commission’s website allowing them to continue to be used in food supplements in accordance with Article 4 (6)(a) and (b) of Directive 2002/46/EC. These substances may be used by any operator in any product and are allowed to remain on the market until 31 December 2009 providing EFSA has not given an unfavourable opinion.
However certain dossiers supporting the use of a vitamin or mineral substances in food supplements, submitted to the FSA, for assessment by EFSA, were very basic. The European Commission wrote to the FSA in August 2005 indicating that additional information would be required for such basic dossiers. This request for information was also sent to those who had submitted these dossiers. Additionally, the FSA wrote to those who had submitted these dossiers in December 2006 and February 2007 reminding operators of need to submit further information.
EFSA has now sent a letter to the FSA on 29 October informing us that if they have not received dossiers according to the relevant SCF/EFSA guidelines by 31 December 2007, or a commitment to send such dossiers within a three month period, then the panel which is assessing the dossiers will have to adopt an opinion stating that the safety and bioavailability of the associated substances cannot be assessed on the basis of the data submitted.
It is not clear what the status of such opinions would be under Directive 2002/46/EC, with regard to the continued sale of products containing these substances. The FSA is consulting the Commission on this issue.
Operators who submitted these dossiers have been advised to send the required full dossiers of information directly to EFSA by their deadline of 31 December 2007, or respond to them confirming whether the relevant information would be available within a 3 month period.
Operators using a substance for which derogation currently exists but who did not themselves submit a dossier for that substance are advised to regularly check EFSA’s web-site and the Commission’s dossier list which are updated as opinions are published and dossiers are withdrawn.
Guidance notes on these Regulations can be accessed at the link below. Companies who wish to market particular nutrients or nutrient sources in other Member States should check with the (External) relevant competent authority on their requirements with respect to current derogation.
Additional dossiers may still be submitted directly to the (External)
European Commission
. Derogation will not apply to the substances covered by these dossiers as they would not comply with Article 4(6) (a) and (b) of Directive 2002/46/EC.
Following the publication of a positive opinion on a substance by EFSA, the Commission will bring forward proposals to add the substance to the positive list in the Directive. Additions will be agreed at the EC Standing Committee for the Food Chain and Animal Health. The first amendment to the list has now been implemented in the UK by parallel legislation in England, Wales, Scotland and Northern Ireland. This came into force on 6 April 2007 and adds Calcium methyl-folate and Ferrous bis-glycinate to the positive list.
Withdrawal of dossiers submitted to the EC under Article 4(6) of Directive 2002/46/EC on food supplements:
More than 70 dossiers have now been withdrawn from the safety assessment process, either because the substances were not considered to be within the scope of the food supplements directive, or that they are no longer being manufactured or sold by the applicant as food supplements. There are three potential consequences of the withdrawal of dossiers on the continued sale of products in the UK, depending on the nature of the substance. These are outlined below:
1. Substances that may not be sold as food supplements in the United Kingdom.
Several substances, for which dossiers were originally submitted, have been classified as medicinal by the Medicines and Healthcare products Regulatory Agency (MHRA) and may not be sold in the form of food supplements in the UK. The substances are lithium orotate, potassium salicylate and sodium salicylate. Therefore the dossiers for these substances have been withdrawn and the derogation for these substances does not apply as they are considered to be outside of the scope of the food supplements directive according to article 1(2) as they have been classified as medicinal.
2. Substances that do not require safety assessment under Directive 2002/46/EC on food supplements and may continue to be sold as food supplements.
Two substances, para-amino benzoic acid and glucosamine sulphate potassium chloride, have been withdrawn as they are not considered to be within the scope of Article 4(1) of the Directive, that is, they are not considered to be a source of a vitamin or mineral. These substances therefore, are currently not required to undergo a safety assessment and may continue to be used in food supplements.
3. Substances that may continue to be sold only until 31 December 2009
In the UK, derogation applies to all substances where a dossier was submitted to the EC by 12 July 2005 and therefore, under the Food Supplement Regulations, a product containing one or more of these substances may continue to be sold until 31 December 2009, provided that EFSA have not given an unfavourable opinion on their use. This derogation will still apply to substances for which dossiers have now been withdrawn, provided that there are no concerns regarding the safety or medicinal status of the substances. After 31 December 2009, these substances may not be sold in food supplements. If another manufacturer has been relying on a dossier submitted by another company to have the product added to the positive list, the manufacturer concerned will need to submit a dossier of safety data to the Commission as soon as possible, to allow sufficient time for it to be assessed by EFSA and added to the positive list, before the end of the derogation period. More than 70 dossiers have been withdrawn on the basis that these substances are not used or are no longer being used by the original applicant in products on sale in the UK.
A list of dossiers submitted to the Commission is available on the (External) Commission’s website and the list is updated regularly to indicate whether dossiers have been withdrawn.
The contacts for enquires regarding food supplements are:
Colin Clifford
Novel Foods, Additives and Supplements Division
Food Standards Agency (England)
Room 515 B Aviation House
125 Kingsway
London WC2B 6NH
Maria Tocher
Food Standards Agency (Scotland)
St Magnus House 6th Floor
25 Guild Street
Aberdeen
AB11 6NJ
Hilary Neathey
Food Standards Agency (Wales)
11th Floor Southgate House
Wood Street
Cardiff
CF10 1EW
Karen Flanigan
Food Standards Agency (Northern Ireland)
10A-10C Clarendon Road
Belfast
BT1 3BG
Download pdf
(pdf 45KB) Final report of the EVM Food Supplements (England) (Amendment) Regulations 2007 Read the consultation documents Food Supplements (England) (Amendment) Regulations 2007 Regulatory Impact Assessment Food Supplements Regulations 2003: Guidance notes See guidance notes in full Guidance on the information to be included in dossiers Guidance issued by the Scientific Committee on FoodDownload pdf
(pdf 23KB) Response to EC proposals to set maximum vitamin and mineral levels in food Vitamins and minerals stakeholder meetingIn October 2003 two sets of proceedings started in the High Court of Justice of England and Wales, seeking annulment of the national domestic legislation implementing the provisions of the Food Supplements Directive (2002/46/EC).
Download pdf
(pdf 34KB) FSA 05/09/02 Food Supplements Directive: Maximum safe levels of vitamins and minerals in supplements (Annexe 1)Download pdf
(pdf 10KB) FSA 05/09/02 Food Supplements Directive: Maximum safe levels of vitamins and minerals in supplements (Annexe 2)Download pdf
(pdf 22KB) FSA 06/09/04 - Vitamins and Minerals in Food Supplements and Fortified FoodsDownload pdf
(pdf 27KB) FSA 06/09/04 Annexe - Vitamins and Minerals in Food Supplements and Fortified FoodsDownload pdf
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