At the end of 2008 a clutch of new regulations on food additives, flavourings and enzymes were adopted, together with a common authorisation procedure for these (EC 1331/2008; 1332/2008; 1333/2008; 1334/2008). These entered into force on 20 January this year.
The European Commission asked the European Food Safety Authority (EFSA) for its opinion on data that would be required for the risk assessment of flavourings, with a view to informing the preparation and submission of applications. EFSA’s CEF panel (food contact materials, enzymes, flavourings, and processing aids) has now published its draft guidance.
The document has been opened up to consultation and interested parties are invited to make comments until 7 December. The draft guidance and instructions on how to make comments are available here.
The food risk assessor has been conducting a lengthy safety assessment of some 2800 flavourings already on the market in the EU, which is expected to be completed soon. The new draft guidance relates to new flavourings to be placed on the market, but EFSA said it this reflects experience it has gained during the ongoing evaluation process.
The European Flavour and Fragrance Association (EFFA) said it is too early for industry to give a view on the guidance, but an indication of how the guidance is being received will be given over the coming months.
EFSA has said the final guidance will be finalised in early 2010 and will take into consideration comments received.
EFSA has already conducted a consultation on draft guidance published in April for submissions for enzymes approval under the common authorisation procedure.
The Association of Manufacturers and Formulators of Enzyme Products (Amfep) has said it is “gratified” to se that a number of its comments to the draft have been included in amendments.
However a particular area of ongoing concern is that the guidelines still appear to be highly product- and manufacturer specific, Amfep said last month.
“Overall, Amfep feels that mutual understanding between the enzyme industry and the EFSA CEF Panel is required on how the guidelines will be implemented in practice, particularly in relation to the construction of the dossiers and their subsequent evaluation.”