The regulation (1925/2006), which is intended to control voluntary addition of vitamins and minerals through a positive list, purity levels and minimum and maximum levels, was published in December and will be applicable across all member states from July 1 2007.
Its aim, according to the FSA, is to provide a higher level of consumer protection and harmonise legislation across the EU to facilitate trade within the community.
The FSA has put together a draft guidance document aimed at food business operators, a draft statutory instrument setting out enforcement provisions, and a regulatory impact assessment.
It is seeking comments on all of these, particularly since some of the provisions have had to be interpreted. Where an interpretation has been made, and in the absence of case law, it does not want to go further than the minimum legal requirement in conforming.
In particular, the agency is drawing attention to certain points that may need discussion with stakeholders. For instance, its view is that the addition of vitamins and minerals to restore levels that are lost during the course of manufacture and processing is covered by the regulation.
It is asking for comments to help refine this view, especially with regard to whether there is a requirement for minimum levels of nutrients.
The agency said that comments on what purity criteria should apply to vitamin formulations and mineral substances that are not already covered by existing EC legislation and international recommendations.
The guidance also includes a quick guide for small businesses, on which the agency would like to receive comments from small and medium enterprises (SMEs).
The setting of maximum levels of vitamins and minerals, which forms part of food fortification regulation as well as the 2002 supplements directive, is a hot topic in Europe, as different countries would prefer levels that would allow them to keep existing products on the market.
The UK has proposed a two-tier system that would allow the EU to set maximum levels, but for individual countries to continue to allow products with higher levels provided they carried warning labels.
For the first time, the FSA will not be making its guidance documents available in hard copy for reasons of sustainability. Rather, it plans to provide them as .pdf documents and to develop a web-based version.
The FSA is planning a stakeholder meeting to discuss the guidance on May 3, and is accepting comments on its draft documents until May 24.
