The regulation, as yet only a working document, is part of Europe's aim to harmonise food laws across the European community and replace the directive 89/107/EEC (the food additives framework directive) with separate laws for additives, colours, sweeteners and enzymes.
However the requirements in the Commission's latest draft would involve major costs to supplement makers using enzymes and slow innovation in health foods where developments in enzymes are expected to offer opportunities for improving nutritional profiles.
In order for an enzyme to be submitted to an EU positive list, it would need a dossier of safety evidence, as well as proof of its 'technological need' that cannot be achieved by other means.
Currently some enzymes used as additives are regulated under Directive 95/2/EC on food additives other than sweeteners and colours, whereas others that are used as processing aids are subject to the laws of individual member states.
Furthermore, the lawmakers have gone further than the now typical positive lists and prior approval process, by proposing that enzymes go through a reauthorisation process every 10 years.
"Whilst the notion of Community lists and prior approval is nothing new, reauthorisation most definitely is new and the enormous burden that would be placed on companies reapplying with dossiers of evidence every ten years would be substantial," commented Chris Whitehouse, MD of health industry lobbyists The Whitehouse Consultancy.
"Creating legal uncertainly in this way, which will apply even for widely accepted food enzymes, has the potential to be highly damaging," he added.
David Hare, account manager for this sector at the Whitehouse Consultancy, believes that the final 'draft regulation' will closely resemble the working document released on 2 February as member states have largely showed their support for it.
In the UK the Food Standards Agency (FSA) issued a consultation letter on 11 March summarizing both the new EU regulation on enzymes and one on food additives. Comments were to be forwarded directly to the Commission by 31 March.
"No more consultation will happen formally so there is little anyone can do, although food operators could voice their concern with the Commission," he told NutraIngredients.com.
"The Commission is increasingly trying to make sure the industry is united on things and so if industry got together and opened up dialogue with them they may be able to stall the regulation as sports nutrition manufacturers have done with the sports nutrition directive."
"Now is the best time to make changes as once the regulation has become a Commission proposal, it will be reluctant to make modifications," added Hare.
The Commission releases a working document on a regulation prior to publishing it as a draft proposal, which is then consulted by the Parliament and Council.
Enzymes in food are currently staring at relatively flat growth, of about 2 to 3 per cent. But while the volumes of pure enzyme protein produced are very small, their value reached over $2 billion (€1.53bn) in 2004, according to BCC market analysts.
Enzymes are thought to have significant potential in food processing and in development of safer, healthier foods, leading to forecast growth to about $2.4 billion in 2009.
Standalone enzymes, such as bromelain extracted from pineapple, and lactase for people with lactose intolerance, are also marketed as food supplements.