EFSA publishes data guidance for flavour approvals

EFSA reassessing flavouring substances that are already in use in the EU, numbering around 2800 in all. However it has asked for more tests on some 530 substances, including some that have been assessed by bodies like the FAO/WHO’s JECFA committee. The list of flavouring substances needs to be adopted by the end of 2010, and will be included in the new flavouring regulation 334/2008 was adopted at the end of 2008.

New flavouring substances proposed for foods, however, will have to go through a risk assessment procedure, and petitioners will have to supply data to allow EFSA’s panel to form its opinion.

The draft guidance was published in November 2009 for public consultation, and some meetings have taken place between stakeholders, notably between the European Flavour Association (EFA) and EFSA.

The guidance document, available here​, was adopted on 20 May but only published this week.

EFSA said its panel considers it important to build on experience gained during the reassessment, and where possible new flavouring substances will be assigned to one of the existing flavouring group evaluations on the basis of structural and metabolic similarities.

For these groups, scientific principles and a group-based approach have already been drawn up. Data requirements for these chemically-defined substances are included in part A of the guidance.

The guidance will be particularly helpful for data submission on new flavourings that cannot be put into any existing group, however, as it sets out a procedure that will allow for individual evaluation. This is included in part B of the guidance.

Generally speaking, the panel will require data on:

Identity of source materials

Manufacturing process

Specifications

Assessment of dietary exposure

Toxicological data

New regulation​

In an interview with FoodNavigator.com in January, EFFA president Heinrich Schaper said the main objectives of the new regulation are promoting the effective functioning of the internal market and giving high level of consumer protection.

One major change is the new and more detailed labelling requirements for natural flavours, and the reclassification of nature identical and artificial flavours as ‘flavouring substances’. These new requirements need to be on labels and in documentation by January 2011, but flavour firms’ regulatory and IT teams have been working on making sure the raw materials are classified for compliance for some time.