Record breakers26 April 2013
The EU food enzymes legislation has the chance to enter the history books as one of the most monumental constructions in EU law. Youri Skaskevitch of the Association of Manufacturers and Formulators of Enyzme Products explains.
In late 2008, EU legislators agreed on the final text of the EU regulation on food enzymes. The document is part of a broad legislative initiative commonly referred to as the Food Improvement Agents Package (FIAP). In addition to food enzymes, the FIAP lays down rules for food additives and flavours on the EU market. The new approval procedure covering these substances largely relies on a safety assessment carried out by the European Food Safety Authority (EFSA). The European Commission then acts as a submission counter for the applicant and, with the help of member states, grants approval.
The EU food enzymes regulation
is the result of a hard political compromise, which has put an end to three decades of bargaining. During these years of uncertainty, many more or less successful attempts were made to regulate various production methods and very specific uses of food enzymes in food processing. This has resulted in a patchwork of discordant rules adopted at different levels, causing a great deal of confusion today. The harmonised rules of the game are intended to bring about coherence because they are applicable to all food enzymes regardless of the production process, or whether they are sold individually or used in the manufacturing of food traded in the EU.
These changes will not happen overnight. Enzymes are by no means new; hundreds have been used in food production for many decades. Many have been approved in France and in Denmark - the only two member states with pre-market approval for food enzymes. This is why EU regulators have decided to allow enough time for applicants to send in dossiers for existing products, and for EFSA and the European Commission to evaluate them.
It is only after this bulk evaluation is completed that the first EU positive list of food enzymes will be published, which is unlikely to happen before 2020. This publication will officially terminate the transition period and launch a new centralised EU approval mechanism of new food enzymes. Only then will the rules, applicable today at national and EU level to the placing on the market of food enzymes, be repealed.
At present, the road to this future system seems to be very bumpy for all parties involved. Innovation has become a synonym for the European enzymes industry, but it has also become one of its biggest challenges. Innovation makes it virtually impossible for an outsider to grasp the modern production techniques and catch up with the latest technological advancements. The authorities, which have little experience with food enzymes and their uses, are not yet comfortable with the mission conferred upon them.
As a result, they tend to ask the applicant to provide information and/or run costly and lengthy tests that may go beyond what is physically possible. These requirements may even be disproportionate, because they relate to enzymes that have been safely used for decades and, in some cases, for millennia.
Dialogue and coordination
The real danger in this situation is that it risks placing the bar too high for small and medium-sized companies, which make up 90% of EU food enzymes organisations. Faced with an average €300,000 bill per food enzyme application, some SMEs may find it easier to discontinue their independent activities in Europe. This situation could stimulate further concentration of the market, reducing the diversity and eventually increasing the bill for the consumer. This dramatic scenario is, alas, very realistic, and has been experienced by other sectors within the food chain.
For the last 35 years, the food enzymes industry, represented by the Association of Manufacturers and Formulators of Enzyme Products (Amfep), has been engaged in a constructive discussion with authorities at all levels. Speaking with one voice, enzymes producers have offered their expertise, contributed to the shaping of the present regulatory framework and are now actively involved in its implementation.
This mutually beneficial cooperation has resulted in common understandings with authorities on specific technical issues related to the production and the use of food enzymes in food manufacturing. Thanks to this dialogue, it is now possible for a group of companies - be that manufacturers, formulators or users of food enzymes - to join efforts and submit one dossier for a specific food enzyme. This initiative is intended to help SMEs decrease the number of animal trials and relieve authorities of a large part of the evaluation burden. Amfep has been very active in facilitating joint submissions, involving companies that are not necessarily Amfep members.
Time to adapt
Since the publication of the FIAP, the number of regulatory instruments applicable to the approval of food enzymes has risen to ten. These legally binding texts and are guidelines that clarify for the applicants the submission practicalities. The latest text was published in November 2012, extending the window allocated for the submission of dossiers for existing products until March 2015. It was very much welcomed by the food enzymes industry, because of the need to adapt to the new rules. This extension will also benefit public authorities, which now have additional capacities to adapt to the forthcoming evaluation of food enzymes.
Although many grey areas have now been clarified, several vital variables remain dependent on very unclear assumptions. In particular, it is not yet known exactly how food enzymes will be approved in the EU and what conditions will be attached to their use.
It is very likely that the EU's positive list of food enzymes will be complex. It will combine approvals, issued to specific companies (like in the pharmaceutical industry) with so-called generic approvals (like approvals granted for food additives), allowing all firms to sell the product approved, provided that it complies with specifications set forth in the approval.
In addition, finding the right vehicle to inform consumers about the role of enzymes in food processing is complex and should not compromise the essential information: safety and well-established consumer needs, such as the energy intake of foodstuffs.
Descriptions on packs of enzymatic processes used to produce foods or food ingredients would also be of little value to the consumer, and risks diluting the other important health and safety information they might be interested in. In this context, the recently upgraded EU rules on consumer information present a balanced approach towards enabling consumers to make informed choices.
These and similar discussions are likely to continue in the coming years. At present though, the food enzymes industry is busy compiling dossiers, and is very much committed to ensuring compliance with the new EU rules and uninterrupted supplies to their customers.