Enzyme industry responds to EFSA’s draft safety guidelines

By Caroline Scott-Thomas

- Last updated on GMT

Related tags Enzyme Food European union

The Association of Manufacturers and Formulators of Enzyme Products has welcomed EFSA’s draft guidelines for assessing food enzyme safety, but cautioned that regulation should be proportionate and clear.

Amfep’s comments follow the publication of the European Food Safety Authority’s (EFSA) draft guidelines on the subject, opened for consultation earlier this month.

The adoption of the new FIAP (food improvement agents package) regulation (1331/2008) at the end of 2008 means enzymes used as processing aids must be approved prior to their use in the UK. Until now, approval has not been required for most of the EU, with the exception of France and Denmark.

Simplified process

Industry has largely come out in support of a unified approach to assessing enzyme safety, instead of having to undergo separate approval processes in France and Denmark.

Amfep, which represents enzyme manufacturers that supply around 90 per cent of the European industrial enzyme market, said that it welcomed the guidelines, and that it would be putting together a formal input document for the EFSA public consultation in due course. In the meantime, it has issued a statement outlining some general points that it considers to be “of great importance”​ for establishing the new safety rules.

Using current requirements

It said: “Food enzymes have been used safely throughout the world for decades, in the manufacturing of safe and high quality food…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.”

It added that safety evaluations should also be based on those that are already being used in the EU in order to keep the re-evaluation time of enzymes that are already on the market as short as possible.

Amfep also highlighted the need for food enzyme safety requirements to be “proportionate and flexible”.

It said: “Depending on the source used to produce a food enzyme, a full set of toxicological studies may not be necessary in all cases.”


Finally, the organization said that EFSA should make its requirements clear to manufacturers, to provide predictability and certainty about regulatory conditions.

“[Decision criteria] 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,”​ it said.

Enzymes are added to foods to improve texture, appearance or nutritional value, or to helping achieve optimum results in certain food production processes, such as cheese making or beer brewing.

Full details of the consultation, which is open until 8 June, are available at http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902439387.htm​.

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