Presentation and regulatory framework
Updated on 03/08/2016
Processing aids, Additives
Processing aids are substances which are not consumed as food ingredients on their own, but which are deliberately used during the processing or transformation of raw materials, foodstuffs or their ingredients in order to fulfil a given technological objective. Aside from enzyme preparations, which are regulated on the EU level, all processing aids are regulated in France on the country level. ANSES assesses them before they are marketed.
Processing aids are substances which are not consumed as food ingredients on their own, but which are deliberately used during the processing or transformation of raw materials, foodstuffs or their ingredients in order to fulfil a given technological objective. Their use may result in the unintentional but technologically inevitable presence of residues of the substances or their by-products in the finished product, provided they do not present any health risk and that they have no technological effects on the finished product.
In France, the processing aid categories currently authorised include anti-foaming agents, decontamination agents for plant-based products, mold-release agents and extraction solvents.
Only processing aids in the enzymatic preparation category are subject to EU-wide harmonised regulation. These preparations, which until now have been submitted in France for case-by-case authorisation, will gradually be subject to the new EU authorisation system after evaluation by the European Authority for Food Safety (EFSA). They will therefore be subject to the standardised evaluation procedure defined by Regulation EC/1331/2008 and the specific regulation for enzymes, Regulation No. EC/133/2008.
The French regulatory framework
France is one of the only European countries which have issued specific conditions for the assessment, authorisation and use of all other types of processing aids via its Decree no 2011-509 of 10 May 2011 and Order of 7 March 2011.
Regarding processing aids other than enzyme preparations, the Decree of 10 May 2011 specifies that those not included in the list established by the Order of 19 October 2006 must be assessed by ANSES on request from the Directorate General for Fair Trading, Consumer Affairs and Fraud Control (DGCCRF).
This Decree also includes special provisions for processing aids that are already used but for which an extension of use is being considered, or for processing aids which are legally produced or marketed in other Member States of the European Union.
The Order of 7 March 2011 specifies the information and recommendations required for compiling a Marketing Authorisation request file for a new processing aid. These recommendations are based on the ANSES Opinion of 14 January 2011.
These recommendations include requests for documentation concerning the identity and chemical characterisation, detection process, technological role, outcome in the foodstuff, analytical methods used, harmlessness and safety of use of the processing aid. In its Opinion, ANSES also specifies that consumer exposure for the uses requested must be documented. To help industrial applicants complete this process, ANSES has developed a tool for calculating the exposure (see also the explanatory note on how to use it) incorporating food consumption data for the French population based on the latest Individual and National Study on Food Consumption (INCA 2 - synthesis available in English).
Due to these modifications to the rules applicable to processing aids, the previous document entitled Guidelines for Compiling Files on the Use of Processing Aids in Human Foods, published by the Agency in 2001, is no longer applicable.
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