NATCOL welcomes DG SANTE Roadmap for Risk Management of Re-evaluated Food Additives.

In its new web page dedicated to the re-evaluation of food additives the European Commission (DG SANTE) presents its re-evaluation program, a table on the permitted food additives and status of their re-evaluation by EFSA also including a spreadsheet for colours.

NATCOL welcomes the clarity made regarding the approach the Commission will take on the EFSA re-evaluation of permitted additives for which some concerns have been identified and for which a follow up is required.

The risk management decision on whether an additive and its uses/use levels remain permitted, and/or on the content of its specifications will be taken based on the outcome of EFSA’s final scientific opinion. This enables products to remain on the market until new data is provided.

If the requested data is not submitted or if the new data is not sufficient for EFSA to conclude the risk assessment, the additives may be removed from the Union list of permitted additives. There will be no successive requests for additional data.

NATCOL expects the Commission to issue a call for scientific and technical data on Chlorophyllins (E140ii), Copper complex of Chlorophylls (E140i) and Copper complexes of Chlorophyllins (E140ii).

The process

DG SANTE will issue a call for scientific and technical data summarising the conclusions of the EFSA’s scientific opinions on the re-evaluation of safety, the issues identified by EFSA that require a follow up and the new data necessary to address them.

Requests for extension of use or amendment of specifications will not be dealt with until the issues raised by EFSA are satisfactorily clarified.

Where limited data availability was identified by EFSA, business operators will be asked to indicate to the Commission (within 6 weeks in general) whether they are interested in the continuity of approval of the additive(s) and in providing the data needed by EFSA to complete the risk assessment (step 1). The list of business operators interested in submitting data will be published on this new DG Sante web page.

The interested business operators will then have to confirm within 12 or 24 weeks (if toxicological studies are needed) that they will submit the new data required and provide the timeline and its justification (step 2). Intermediate milestones will be identified and the Commission will have to be kept informed about their timely achievement. The timeline for data submission and milestones should be in line with EFSA’s report on Indicative timelines for submitting additional or supplementary information to EFSA during the risk assessment process of regulated products.

The data to be submitted, deadlines and milestones will then be published on DG SANTE’s web site.

Where concerns in terms of exposure or specifications were made by EFSA in its scientific opinion, the same follow up approach will be followed, but EFSA’s assessment of the new data may not always be needed.