The market for both fortified foods and food supplements is rapidly changing and expanding as public interest in the healthy lifestyle ideal increases.
There has also been increased interest in this area by the European Commission and the Food Standards Agency. Recently there have been three developments in this area:
1. The transposition of Directive 2002/46/EC on food supplements into UK law by way of the draft Food Supplements Regulations (England) 2003. (Consultation ends 15th January 2003.
2. The Expert Group on Vitamins and Minerals (EVM) have drafted a report on the maximum levels of vitamins and minerals that are safe to consume. (Consultation ends 21st November 2002.)
3. Further amendments have been made to the Codex Alimentarius Commission Guidelines on Nutrition Labelling and Draft Guidelines for Use of Health and Nutrition Claims imposing further conditions for the making of health and nutrition claims. (Consultation ends 18th December 2002.)
1. Draft Food Supplements Regulations (England) 2003
Regulations to implement Directive 2002/46/EC are to be introduced by 31st July 2003 and will come into force on 1st April 2005 (with the exception of the provisions relating to Schedule 1, which are proposed to come into force on 31st July 2004.)
For the first time, legislation will provide a definition of the term “food supplement this is stated as
“any food the purpose of which is to supplement the normal diet and which-
(a)is a concentrated source of a vitamin or mineral or other substance with a nutritional or psychological effect, alone or in combination; and
(b) is sold in dose form.
The legislation aims to introduce a list of the vitamins and minerals that may be used in food supplements together with a list of the permitted chemical forms (sources) of these vitamins and minerals at Schedules 2 and 3 – the so-called “positive lists.
Article 4 of the Directive contained a derogation allowing member states to permit, subject to the conditions set out, the continued use of vitamins and minerals not on the “positive lists until 31 December 2009. The UK have made use of this derogation, which will apply to all those products that fulfil the conditions set out in Regulation 5(4), namely
(i) that the substance was used in the manufacture of a food supplement which was on sale in the European Community on 12th July 2002,
(ii) a dossier supporting use of substance in question was submitted to the Commission by the Food Standards Agency or another member state by 12th July 2005,
(iii) the European Food Safety Authority has not given an unfavourable opinion in respect of the use of that substance, or its use in that form in the manufacture of food supplements, and
(iv)the substance in question is not in a form listed in Schedule 1.
Schedule 1 lists prohibited substances, the UK draft currently prohibits the use of two substances only – chromium picolinate and menadione, and this will come into effect from 31st July 2004. This provision had been added due to concern about the safety of these substances, highlighted by reviews carried out by the Food Standards Agency’s expert group on vitamins and minerals (EVM) draft report. (The substances have been included as a precautionary measure and if evidence is submitted of their safety, they may be removed, if appropriate.)
All vitamin or mineral supplements that are sold directly to the ultimate consumer must be pre-packed under the directive and the draft regulations. Mandatory labelling requirements for food supplements in addition to those applied to most foodstuffs by the existing Food Labelling Regulations 1996 (as amended) are required and the sale of food supplements that do not comply with these requirements will be prohibited.
However, producers have been spared some red tape in that the provision under Article 10 of the Directive which allowed Member States to require the manufacturer or the person placing the product on the market to notify the competent authority of that by forwarding to it a model of the label used for the product has not been included in the UK draft regulations.
Any contravention of these Regulations shall involve the commitment of an offence under strict liability and liable on summary conviction to a fine not existing level 5 on the standard scale.
The UK Regulations implement enforcement and defence provisions set out in the Food Safety Act 1990, most notably the due diligence defence and defence of publication in the course of business and also provides the defence as stated in the Directive in relation to exports, namely that it would be a defence for the person charged to prove –
(a) that the food in respect of which the offence is alleged to have been committed was intended for export to a country which has legislation analogous to these Regulations and that the food complies with that legislation; and
(b) in the case of export to [a member state] that the legislation complies with the provisions of Directive 2002/46.
The EVM report also highlighted concerns over germanium and vanadrum. Germanium is currently subject to a voluntary ban on its use in supplements in the UK. It is proposed that this arrangement continues and so there is no plan at present to include germanium in Schedule 1. The use of vanadrum in supplements is not currently controlled in the UK and options as to whether this should be subject to a voluntary or a statutory (inclusion in Schedule 1) ban are being reviewed.
2. Draft Report of the Expert Group on Vitamins and Minerals
The Expert Group on Vitamins and Minerals (EVM) have advised on the safety intake levels and safe upper levels (SULs) of 34 vitamins and minerals in food supplements and fortified foods. For each nutrient a detailed review and risk assessment has been undertaken based on the available evidence and comments received from interested parties. The full report can be accessed on: www.foodstandards.gov.uk/foodindustry/Consultations/ukwideconsults/evmdraftrep
The Food Standards Agency is consulting on behalf of the EVM on the risk assessment included in this draft report. The consultation will end on 21st November 2002.
The recommendations for SULs depend on the availability of good data on the nature and frequency of adverse effects detected at different levels of intake. However, the Food Standards Agency highlight that the database supporting the safety in use of vitamins and minerals is generally poor and that there is a particular lack of reasonable sized, well designed comparative human studies of significant duration at different levels of intake. In addition, the Food Standards Agency believe that there has rarely been adequate consideration of potentially vulnerable population sub-groups such as children or older people. In the event that the EVM has been unable to give categorical advice on SULs where possible, guidance levels have been given instead. These guidance levels must not be confused with, or used as, SULs. The EVM also invite comments on scientific evidence that may have been missed or on interpretation of the science itself.
The EVM was not asked to consider the beneficial effects of the vitamins and minerals under consideration. However, nutritional need was taken into account in setting safe upper levels. The non-nutritional efficacy of vitamins and minerals has not been considered by the EVM since such effects would be classified as medicinal and would be within the remit of the Medicines Controls Agency.
The Food Standards Agency has countered the argument that since vitamins and minerals are essential for human health, it is not appropriate to assess them in the same way that other chemicals added to food are assessed, by stating that since there is evidence that excessive intakes of some vitamins and minerals can cause harm, it is not appropriate to exclude essential vitamins from the safety assessment that is applied to other chemical substances as added to food.
As vitamins are not always stable the EVM report also deals with the practice of using “overages within the food supplement industry. “Overage means the formulation of a product with more than the declared content of a particular nutrient to ensure that there is a sufficient level of the vitamin or mineral throughout the shelf life (particularly common with fat soluble vitamins such as vitamins A, D and E). The EVM provide data on typical levels of overage in Annex 4 of their report. It is stated by the Food Standards Agency to be essential that consistent validated methods for the analysis of levels of vitamins and minerals in supplements and fortified foods are available that enable levels present to be independently verified.
3. Draft amendment to the Guidelines on nutritional labelling and for use of health and nutrition claims
This consultation ends on the 18th December 2002 and concerns the various amendments made to the draft amendment to the Guidelines on nutrition labelling (at step 6) and draft Guidelines for use of health and nutrition claims (at step 6) – CL2002/37-FL-July 2002.
The main amendments to the proposed draft amendment to the guidelines on nutrition labelling, amend section 3.2.1 in that where the nutrition declaration is applied, there should be mandatory declarations in relation to the amount of any other nutrient for which a health as well as a nutritional claim is made.
The amounts of total sugars, dietary fibre, saturated fatty acids and sodium where these may be declared
(a) on a voluntary basis,
(b) on a mandatory basis (i) if they are the subject of a nutrition claim or (ii) if a health claim is made for the food.
Where a claim is made regarding the amount and/or type of fatty acids, the amounts of saturated fatty acids, and polyunsaturated fatty acids should be declared.
Section 3.2.6 has been changed from requiring only those vitamins and minerals which are present in significant amounts to be listed to only those vitamins and minerals which are present in amounts less than 5% of the nutrient reference value or of the officially recognised guidelines of the national authority per 100 grams or 100 millilitres or per serving as quantified on the label should not be declared.
Section 3.2.7 is also added in that in the case where a product is subject to labelling requirements of a codex standard, the provisions for nutrient declaration set out in that standard should take precedence over but not conflict with the earlier sections of these guidelines (section 3.2.1 to 3.2.6).
The proposed draft guidelines for Use of health and nutrition claims are amended in that now nutrition and health claims are not permitted for foods for infants and young children unless specifically provided for in the relevant codex standards.
A health claim means “any representation that states, suggests or implies that a relationship exists between a food or a constituent of that food and health.
Various amendments to health claims have been made dealing with both function claims and reduction of disease risk claims. A separate section on health claims has now been inserted detailing conditions that are to be met before a health claim is permitted. These include that:
- health claims must be based on current relevant scientific substantiation and the level of proof must be sufficient to substantiate the type of claimed effect as recognised by generally accepted scientific review of the data and the scientific substantiation should be reviewed as new knowledge becomes available.
- The claimed benefit should arise from the consumption of a reasonable quantity of the food or food constituent in the context of a normal diet.
- Only those essential nutrients for which a nutrient reference value (NRV) has been established in the codex guidelines on nutrition labelling or those nutrients which are mentioned in officially recognised dietary guidelines of the national authority have in jurisdiction, should be the subject of nutrient function claim.
- Health claims should have a clear framework for qualifying and/or disqualifying conditions for eligibility to use the specific claim.
Also further information on the labelling of the food bearing health claims is required, to include a statement of the quantity of any nutrient or the constituent of the food that is the subject of the claim, information on the target group, if appropriate, and advice to vulnerable groups. Information on how to use the food and maximum safe intake of the food should also be included where necessary, as well as information on how the food or food constituent fits within the context of the total diet.
The draft amendments are therefore increasing conditions and provisos for any nutrition or health claim.
Summary
These 3 consultations are currently on the Food Standards website. They mark an increase in regulation and investigation in this area of food law. There is however still a lack of understanding and scientific information in this area as evidenced by the EVM report and this is further complicated by the fact that the non-nutritional efficacy and the beneficial effects of vitamins and minerals is not taken into account as it is outside the remit of the Foods Standards Agency. The fact that levels of nutrient can change and the use of “overage has been referred to but there is as yet no consistent, validated method to enable levels of the vitamins present to be independently verified.
The draft Food Supplements Regulations (England) 2003 does take advantage of the available derogations and flexibility provided by Directive 2002/46/EC and the Food Standards Agency will continue with the use of voluntary bans as opposed to statutory bans where this is deemed to be effective. The main cost for business would be in relation to an increase in labelling costs which is estimated by the Food Standards Agency to be in the order of £300-£500 per product (a total of around £10 million for the industry).
This increase in labelling costs will be further highlighted by the more restrictive amendments made to the codex guidelines. However, the Food Standards Agency argue that these are maximum figures because these costs would be “significantly offset by planned re-labelling costs during the 3 year transitional period allowed.
This area of food is becoming much more tightly regulated and the requirements are likely to be thrown back on the manufacturer to provide substantiating scientific documentation to both evidence claims made and to ensure that recommendations made for safe upper levels or guidance levels are correct.
For further information, please contact Jessica Burt by telephone on +44(0) 207 367 3589 or by email at jessica.burt@cms-cmck.com
