EFSA agrees with JECFA on 10 out of 22 flavouring substances

13-Oct-2010 - Last updated on 14-Oct-2010 at 08:35 GMT

EFSA has agreed with JECFA that 10 of the latest 22 flavouring substances to undergo re-evaluation pose no safety concern at estimated intake levels, but more info is required to complete assessment on the remaining 12.

The European Food Safety Authority has been reassessing the safety of flavouring substances permitted in the EU since 1999, in preparation for the positive list to be annexed to the new flavour regulation.

However some 400 of the 2600 substances in use have yet to be assessed, and in may cases EFSA has requested the industry for more data in order to complete its work.

The latest batch of assessments were aliphatic branched-chain saturated and unsaturated alcohols, aldehydes, acids, and related esters. They are structurally related to a group of branched- and straight-chain unsaturated carboxylic acids and esters with aliphatic saturated alcohols previously evaluated by EFSA.

For 20 of the 22 its panel agreed with the procedure carried out by JECFA – the WHO/FAO Joint Executive Committee on Food Additives – but for two, FL-no: 05.148 and 08.079, it pointed out that the JECFA evaluation is only based on MSDI (maximum survey-derived intake) values came from the US and EU production figures would be necessary to finalise the evaluation.

EFSA also said that for the 22 substances use levels are needed to calculate the mTAMDIs – modified theoretical added maximum daily intake) so as to identify flavouring substances that need more refined exposure assessment and to finalise the evaluation.

For ten (FL-no: 02.058, 02.076, 02.109, 05.124, 05.169, 08.047, 08.064, 08.070, 09.408 and 16.001) adequate specifications including complete purity criteria and identity were available and the panel agreed with the JECFA conclusion that “no safety concern at estimated levels of intake as flavouring substances”.

For the remaining 12 (FL-no: 02.011, 02.012, 02.027, 02.029, 05.020, 05.021, 05.148, 08.036, 08.044, 08.055, 08.079 and 09.273) the panel had reservations on the grounds that no European production volumes were available, information on stereoisomerism had not been specified; or further information on the composition was requested.

Plea to industry

The European Commission has asked EFSA to conclude safety reassessments of all the outstanding 400 by 2014. Addressing the EFFA conference in Brussels last week, Michael Flueh, DG Sanco’s head of unit, chemicals, contaminants and pesticides said the industry needs to ensure the dossiers are available to EFSA.

He called on all stakeholders make an effort to give the dossiers to allow EFSA to meet this deadline.

“You will not be able to keep substances on the market after 2014 if it is not fully assessed,” he emphasised. Having to remove substances from the market would result in a chaotic situation where substances currently being used in foods would no longer be legal.

The missing data was not necessarily requested at the start of the reassessment process, but EFSA deems it necessary in order to complete its work.

EFSA as a reference

The outstanding flavour substances have all been approved by the Joint WHO/UN Expert Committee on Food Additives (JECFA), a green light which is seen as adequate in some other parts of the world.

Flueh said that questions have been asked, especially from non-EU stakeholders, as to why the EU authorities cannot accept the evaluation of the on the outstanding flavourings.

“I would like to make it very clear the Commission takes into account Codex and JECFA, but our reference is EFSA,” he said.