FSA Consultation Letter, 31 March 2010
Regulations amending The Addition of Vitamins, Minerals and Other Substances (England) Regulations 2007 to introduce an ambulatory reference to annexes I and II of Regulation (EC) No. 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods.
Responses are requested by: 23 June 2010
Audience
Who will this consultation be of most interest to?
Food business operators manufacturing or selling foods fortified by the addition of vitamins or minerals; enforcement authorities.
What is the subject of this consultation?
Regulations amending The Addition of Vitamins, Minerals and Other Substances (England) Regulations 2007 to introduce an ambulatory reference to annexes I and II of Regulation (EC) No. 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods.
What is the purpose of this consultation?
To seek comments on the draft Addition of Vitamins, Minerals and Other Substances (England) (Amendment) Regulations 2010. Parallel Regulations have been produced in Scotland, Wales and Northern Ireland and consultations on these will run concurrently.
Consultation details
The Addition of Vitamins, Minerals and Other Substances (England) Regulations 2007 (SI 2007 No. 1631) make provision for the execution and enforcement of Regulation (EC) No. 1925/2006 (As amended by Regulation (EC) 108/2008 of 15 January 2008 (OJ No. L39,13.2.2008, p.11) and by Regulation (EC) No 1170/2009 (OJ No.314, 1.12.2009, p.36)). According to regulation 2(1) of the SI, 'the EC Regulation' is defined as Regulation 1925/2006 as last amended by Commission Regulation No 1170/2009.
Article 3.1 of Regulation 1925/2006 provides for the lists of vitamins and minerals and vitamin formulations and mineral sources in the annexes to the Regulation to be amended. These lists have already been amended once2 (by Regulation 1170/2009) and are almost certain to be amended in future (See: The Food Supplements (England) and Addition of Vitamins, Minerals and Other Substances (England) (Amendment) Regulations 2009 (SI 2009 No. 3251)). EFSA has recently published a positive opinion on the use of ferric sodium EDTA as a source of iron added for nutritional purposes to food supplements, foods for particular nutritional uses and fortified foods (See EFSA Journal 2010;8(1):1414). In addition, the FSA, on behalf of petitioners, submitted 14 dossiers for addition of substances to annexe II in January 2010; the competent authorities in other EU member states may have done the same.
In order to provide for enforcement with respect to the substances listed in the annexes to 1925/2006, the SI needs to be amended so that it refers to up-to-date versions of those lists.
Proposals:
Options being considered are:
Preferred option
Each individual change to the annexes could be dealt with by a separate amendment to the Addition of Vitamins, Minerals and Other Substances (England) Regulations. However, the most efficient way to provide for these similar, multiple changes to the SI would be to amend regulation 2(1) so that it makes an ambulatory reference to annexes I and II of 1925/2006 as amended from time to time. We will consult stakeholders, as usual, when future changes to the annexes are proposed and discussed at EU level. However, having the ambulatory provision in place will avoid the need for formal consultations on an amending SI after the directly applicable EU provisions are already in place and when there will be little or no opportunity to change the decision.
Option 2 is therefore the preferred option.
Consultation Process:
A 12-week public consultation is being undertaken on the draft SI and all responses received as part of this consultation will be given careful consideration. These will be summarised and published on the Agency‟s website in due course.
Impact Assessment:
The purpose of an impact assessment is to assess and record the likely costs and benefits of the forthcoming provisions for businesses, consumers and enforcement bodies. The only proposal is to introduce amending Regulations to introduce an ambulatory reference to annexes I and II of Regulation (EC) No. 1925/2006 into the Addition of Vitamins, Minerals and Other Substances (England) Regulations 2007. We do not anticipate that the implementation of the new Regulations will result in any new costs or savings for businesses. Therefore, an impact assessment has not been prepared to accompany these Regulations at this stage. However, if you consider that these Regulations will impose additional costs on businesses or the public sector, please provide evidence and estimated costs in your response to this consultation and we will consider preparing an impact assessment.
Question asked in this consultation:
We welcome comments from all stakeholders. Please send your response by email or post using the contact details above.
Other relevant documents:
Responses:
Responses are required by close 16 June 2010. Please state, in your response, whether you are responding as a private individual or on behalf of an organisation/company (including details of any stakeholders your organisation represents).