EFSA's risk assessment of smoke flavouring Primary Product FF-B

EFSA is currently evaluating the safety of a number of smoke flavourings. These products are added to a range of foods and until recently were not subject to any authorisation process for use
in Europe. EFSA is assessing applications from companies on the safety of their smoke flavouring Primary Products to inform European decision makers in authorising their use in foods.

One of the smoke flavourings being assessed, named Primary Product FF-B, raised concern. The AFC Panel[1] concluded that Primary Product FF-B can be regarded as weakly genotoxic in vivo ( i.e.
animal testing has shown that it can damage DNA, the genetic material in cells). The Panel therefore could not establish its safety in use when added to food.

EFSA has sent the risk assessment to the Commission to help inform their consideration of the necessity of any further measures. The petitioner informed EFSA, on 23 April, of the company’s
decision to withdraw the application and to stop all activities shipping the Primary Product FF-B or derived products to the EU.

EFSA is continuing its work on assessing the safety of the remainder of the smoke flavourings for which applications have been made for authorisation.


Regulation of smoke flavourings
The European Parliament and the Council established Community procedures for the safety assessment and the authorisation of smoke flavourings used or intended for use in or on foods[2]. Under
this Regulation, a smoke flavouring will only be authorised if it is sufficiently demonstrated that it does not present risks to human health. Based on EFSA’s opinions regarding safety, the
European Commission will establish a list of so-called “primary products” (see definition below) authorised in the EU for use as such in or on foods and/or for the production of derived smoke
flavourings for use in or on foods.

Under the Regulation, initial applications for inclusion of a primary product in the positive list of authorised smoke flavourings had to be submitted by manufacturers to the competent
authority of an EU Member State. The applications and their related dossiers were then passed on to EFSA to undertake the safety evaluations. EFSA has received altogether 16 applications for
primary smoke flavouring products. Of the 16 applications, 2 were not valid and one was withdrawn by the applicant who was not able to provide the scientific dossier required for a proper
assessment. The remaining 12 applications are currently under evaluation by EFSA’s AFC Panel.

What is a Primary Product?
Liquid smoke flavourings are produced by controlled thermal degradation of wood in a limited supply of oxygen (pyrolysis), subsequent condensation of the vapours and fractionation of the
resulting liquid products. Liquid smoke flavourings derive from smoke condensates.
Traditional smoking
Smoking of foods, using freshly generated smoke, has been used for preserving foods for thousands of years. This process traditionally applied to certain perishable foods such as fish and meat,
also imparts colour and flavour to food. Liquid smoke flavourings have been used for many years to replace traditional smoking of foods which can generate undesirable substances that may be
hazardous to human health.


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