New EU rules for enzyme market one step closer

By Lindsey Partos

- Last updated on GMT

Related tags European commission European union

Rules authorising enzymes need to be updated and simplified, and
enzymes should be authorised only where the consumer benefits, said
Europe's Environment committee, clearing the next hurdle in a
new legal framework for enzyme players.

At the second reading vote earlier this month on new European regulations for additives, flavourings and enzymes, MEPs stressed that "enzymes should be authorised only if there is a benefit to the consumer" and that "the precautionary principle should apply." Used extensively by food and beverage makers, enzymes perform a wide range of functions in food applications, such as baking, brewing and cheese-making.

In Europe, food additives are currently regulated by a dozen or so EU laws, but four new regulations, proposed in 2006 by Europe's law-making body, the European Commission, aim to harmonise authorisation and safety assessment procedures for Europe's internal market.

The first rule sets out an EU-level "common authorisation procedure" for additives, flavourings and enzymes.

The other three deal in detail with each of these categories, for which lists of authorised products - the positive lists - will be compiled, with conditions of use and rules on labelling.

Only those approved on the positive lists will be allowed for use in food and beverage applications.

The European Commission will manage the lists of approved products subject to risk assessments carried out by the European Food Safety Authority (EFSA).

From the start, the enzyme industry has backed the European initiative to introduce a level playing ground for the European enzyme market.

"The possibility of obtaining one single authorisation which is valid in the entire EU will be advantageous for the internal market," said Amfep, the association of manufacturers and formulators of enzyme products.

And speaking today, prior to the official position for the group expected shortly, a spokesperson at Amfep said "he was basically positive about the meeting."

But a very real concern for enzyme firms today is the unknown costs involved in compiling and submitting product dossiers to EFSA.

Until EFSA publishes guidelines on the procedure, the industry is largely in the dark.

"A concern for enzyme producers are the budget implications over the next few years for 'x' number of dossiers based on 'x' criteria," a spokesperson at Amfep recently told

And not simply these costs; in the event that a certain enzyme would fail to gain approval for the positive list, there would be clear costs linked to the burden of re-formulation.

The industry has already submitted information on best practise to Europe but is unaware if it has been taken on board.

However, EFSA told today that "all information received from stakeholders is taken into consideration."

EFSA is currently drawing up the guidelines for the submission of data on enzymes.

Once the new rules authorising enzymes - as well as food additives and flavourings - are adopted, expected later this year, EFSA has six months to publish these guidelines.

Available for public consultation, the industry will then have a clearer idea of the costs involved for dossier submission, as well as the opportunity to issue feedback on the guidelines.

Enjoying year on year of growth of 8 per cent, the enzyme market is expected to hit €846.2m by 2011, according to market research firm, the Freedonia group.

Novozymes is the leading player, with fellow enzyme producers Danisco, Genzyme, Roche, Allergen, DSM and BASF all holding a stake in this growing market.

The report on enzymes, drafted by MEP Avril Doyle (EPP-ED, IE), was adopted by the Environment Committee at the second reading vote on 5 May 2008, with 51 votes and 1 abstention.

At the meeting the Environment committee not only called for "a more transparent procedure," to govern the "common authorisation procedure" but also stressed that, as with additives, the precautionary principle should apply to enzymes.

Europe's precautionary principle states that the absence of full scientific certainty should not be used as a reason to delay measures where there is a risk of serious or irreversible harm to public health or to the environment.

The plenary vote on the new EU rules authorising food additives, flavourings and enzymes is expected in July 2008.

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