April 30 - The Association of Manfacturers and Formulators of Enzyme Products (Amfep) welcomes the launch of the EFSA public consultation on the draft guidelines for the safety evaluation of food enzymes according to Regulation 1332/2008.
Amfep, representing enzyme manufacturers supplying 90% of the European market of industrial enzymes, intends to provide a formal input document to the EFSA public consultation, before the deadline of 08 June. This input will be made public in due time.
In the meantime, Amfep would like to state a few points of great importance when assessing the safety of food enzymes.
1. Food enzymes have been used safely throughout the world for decades, in the manufacturing of safe and high quality food:
During this period, literally hundreds of food enzymes have been evaluated for their safety by scientific experts in the industry as well as by the authorities. These evaluations have never led to any concrete safety concern. Many of these evaluations are publicly available, either in published articles, as part of national rulemaking or on various authorities’ websites.
Therefore and in the absence of any new scientific information, any newly established set of safety requirements for food enzymes should be based on the existing requirements around the world and in particular those used within the EU. - Likewise, existing safety evaluations performed in the EU should be taken into account by EFSA to shorten and simplify the re-evaluation of food enzymes that are presently on the EU market.
2. Safety requirements for food enzymes should be proportionate and flexible:
Depending on the source used to produce a food enzyme, a full set of toxicological studies may not be necessary in all cases, and clear criteria should be developed to describe such situations. Compliance with existing EU legislation on reducing use of laboratory animals when possible is thus warranted.
Requirements should be limited to the documentation that is necessary from a safety point of view for the food enzyme under consideration. - Applicants should be allowed in practice to submit joint dossiers for the same food enzymes which meet the above criteria. This will enable the work of the Risk Assessor (EFSA) and Risk Manager (Commission) to be better targeted.
3. Enzyme manufacturers and enzyme users (i.e. the Food Industry) need regulatory predictability and certainty:
The decision steps and criteria leading to the formal authorization of a food enzyme must be adequately clear to the applicant to provide for an exact determination of the amount and quality of documentation that will satisfy the EFSA experts.