Europe targets harmonised enzyme regulations

By Anthony Fletcher

- Last updated on GMT

Related tags Food European union European commission

The European Commission has proposed new legislation that would
harmonise EU rules on food enzymes.

The package, which is designed to create a simplified common approval procedure for food additives, flavourings and enzymes, is based on scientific opinions from the European Food Safety Authority (EFSA).

"Food additives, flavourings and enzymes play an important role in the production of food for today's mass market and can offer benefits to the consumer in terms of keeping food fresh and tasty,"​ said Markos Kyprianou, commissioner for health and consumer protection.

"Clear, harmonised rules on the safety approval and marketing of these substances serve to protect the consumer and boost public confidence in the food produced with them. Today's proposal ensures that these rules are based on sound scientific advice and that consumers are afforded the same level of safety, wherever they are in the EU."

The harmonisation of ingredient regulations is being driven by the globalisation of the food industry. Regulators are struggling to accommodate the growing pressure on food companies to get new products out and onto the global markets.

Important steps have been made towards global regulatory harmonisation in a number of sectors. JECFA, the Joint FAO/WHO Expert Committee on Food Additives, which has been engaged in collecting and evaluating scientific data on food additives and making recommendations on safe levels of use since 1956, is an ongoing process.

Some food scientists are hopeful that the work of JECFA could lead to a harmonised system under the UN, whose recommendations would hopefully be taken on by all WTO members.

Last week's EC proposals are therefore part of this global harmonisation process.


Currently food enzymes used as processing aids are not covered by EU legislation. Member States legislation on food enzymes differs significantly, which can lead to problems for the internal market and an unclear situation for the EU consumer.

Under the new legislation proposed last week, harmonised EU rules would be laid down for the evaluation, approval and control of enzymes used in food. The draft regulation foresees the establishment of a positive list of all food enzymes used in food for a technological purpose, based on favourable scientific opinions from EFSA.

The proposal also includes requirements for the labelling of food enzymes other than those used as processing aids. Food enzymes with a technological function in the final food will have to be labelled as ingredients with their function and name.


The new proposed legislation aims to simplify and streamline the food additive approval system, allowing the Commission to update and add to the EU positive list of food additives, following Member State approval in the Standing Committee on the Food Chain and a right of scrutiny for the European Parliament.

All approvals would be based on a safety evaluation carried out by EFSA. The proposal also sets out a re-evaluation system for food additives currently on the EU market, based on risk assessments by EFSA.


The EC believes that existing legislation needs to be updated to reflect technological and scientific developments. The new legislation proposed therefore sets out clearer rules on maximum levels for undesirable substances, in line with EFSA opinions.

Definitions of flavourings (e.g. flavouring substance, flavouring preparation, thermal process flavouring) are clarified and stricter conditions are also introduced for the use of the term 'natural' when describing flavourings.

Finally, a key aspect of the draft legislation is the introduction of a single common procedure for the approval of food additives, flavourings and enzymes.

This approval procedure includes a safety evaluation by EFSA. The benefits of this common approach include simplified legislation and more consistency in the procedures used to approve additives, flavourings and enzymes, which the EC expects will be welcomed by the food industry.

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