On Friday, 6 September 2019, a Regulation amending the General Food Law from 2002 was published in the EU Official Journal. The initiation to amend the Regulation has its roots in the heated arguments around the safety of glyphosate and the claims about the lack of transparency in the risk assessment. Besides plant protection products like glyphosate, the amendment now covers also genetically modified organisms, food and feed additives, food enzymes and flavourings, smoke flavourings, novel foods and food contact materials.
To increase transparency, applications for authorisation submitted to EFSA for scientific evaluation will be made public. This includes all non-confidential information and studies supporting the application. This is not, in fact, an entirely novel procedure. The Food Standards Australia New Zealand (FSANZ) has already had this practice at least for food enzymes. Thus anybody interested has had a possibility to scroll through, even download, an over 1000-page application if (s)he so wishes. The data requirements by FSANZ and EFSA are not much different so one can have a pretty good idea about the content of applications submitted in the EU. FSANZ has also a consultation procedure for the submitted applications.
What is clearly new is that applicants and laboratories carrying out studies will have a notification obligation, basically meaning that studies with undesirable outcome cannot be hidden anymore by excluding them from the application. Further guidance is obviously needed how to fulfil this obligation. How is this accomplished with applicants coming from ouside the EU? There will be a grey area between studies carried out in the R & D phase, and those carried out with the final product.
For the applicants, the Regulation brings a very welcome improvement in that EFSA will provide pre-submission advice on the required content of an application dossier. Currently all legislation and guidelines are available as well-organised packages in EFSA homepage. The new approach must then go clearly further than that. The more innovative the applications are, the more there will be a need to consult EFSA to achieve an optimal outcome from both applicant’s and EFSA’s point of view.
For the laboratories, perhaps the major change will be the Commission fact-finding missions to ensure the compliance of laboratories/studies with appropriate standards. This has a good chance of improving the quality of the studies. However, this should not cause extra financial burden to the laboratories.
The amendment becomes applicable by the end of March 2021. Hopefully this one and a half year is sufficient to ensure that not only Commission and EFSA but also all other parties down the line, Biosafe Ltd included, will be fully prepared to the changes needed.