Below is the text submitted to the UK Food Standards Agency following its request for comments as part of partial regulatory impact assessment on the European-wide setting of potentially restrictive maximum permitted levels of vitamins and  minerals.

ANH CONSULTATION RESPONSE TO:
INITIAL REGULATORY IMPACT ASSESSMENT
Anticipated proposal for setting daily dose levels of vitamins and minerals in food supplements

25 May 2007

We are pleased to offer comments to the UK Food Standards Agency (FSA) following its request for stakeholder views on the anticipated proposal for setting daily dose levels for vitamins and minerals in food supplements.

General comments

1. We feel compelled to indicate that, in our opinion, the procedure for determination of maximum permitted levels in vitamins and minerals as set out in Article 5 of the Food Supplements Directive (2002/46/EC), is one that will lead, in the case of many vitamin and mineral forms, to the setting of maximum levels that are excessively low. Should these levels be enforced legally, many consumers would be prevented from consuming dosages of particular vitamin or mineral forms that are known to be within an optimal range.

2. The German BfR has used what is essentially the Article 5 model in its own determinations and the resultant maximum levels for food supplements have been widely criticized by scientists, stakeholders and other interests across the EU.

3. The main problem with the approaches used thus far for determination of SULs, as typified by that used by the Expert Group on Vitamins and Minerals (EVM), is that it is based on an excessively precautionary model. Some of its limitations are:

a) The Safe Upper Levels (SULs) as determined by the EVM take into account No Observable Adverse Effect Levels (NOAELs) or Lowest Observable Adverse Effect Levels (LOAELs) which are based on the most precautionary findings. In a significant number of cases, these studies either have methodological problems (e.g. Dalton & Dalton 1987 re vitamin B6) or they include studies on nutrient forms which cannot be applied to all members of the same nutrient group (e.g. the findings for synthetic beta-carotene in the CARET 1994 and ATBC 1996 studies cannot be applied to naturally occurring mixed carotenoids which contain natural beta-carotene within a complex of other carotenes). See ANH consultation response to the Draft EVM Report, dated November 2002, attached to the present report for further information.

b) The Guidance Levels set by the EVM cannot be used as SULs, as stated by the EVM itself. Citing from the EVM