EFSA: new rules for submitting applications The Members of the European Parliament passed QUESTIONS AND CHALLENGES in record time (and without a prior impact study) These measures are drastically changing the way new rules concerning the transparency and sus- companies are preparing their dossiers. tainability of risk assessment (Regulation No. Les ingrédients de They must ensure that all studies have been noti- 2019/1381) by the EU. The European lawmaker spécialité peuvent fied. They must also protect sensitive information confirms that the authorization procedures are faire l’objet de by applying for the status of confidential informa- réglementations tion (Editor’s Note: this status is granted by EFSA based on the principle that the applicant’s dossier spécifiques, has to prove the harmlessness of its product. In re- comme les additifs according to its eligibility criteria for the concept cital 19, “the burden of proof is on the applicant... alimentaires et les of “harmed interests to a significant degree”). who has to prove that the subject matter of its ap- Novel Foods. These new transparency rules raise questions plication is safe prior to its placing on the market”. - so far unresolved. What will be the effects on These new rules concern plant protection prod- the competitiveness of innovative players con- ucts, Novel Foods, health claims, the sources of vi- Specialty ingredients sidering that the authorisations granted to Novel tamins and minerals, food additives and enzymes. may be subject to Foods, food additives or enzymes are generic? specific regulations, In order to ensure the sustainability and transpar- such as food And, finally, will the new regulation succeed in re- ency of the assessment, the functioning of both additives and storing the European citizens’ confidence in the the Administrative Council and EFSA’s Scientific Novel Foods. Agency and, moreover, in Europe? • Committee has been modified. The information included in the dossier - except Source: Synpa / www.synpa.org for confidential information - is disclosed. All the studies notified during the preparation of the dossier are also made public. LABORATORIES AT THE HEART OF THE SYSTEM Laboratories and the testing facilities carrying out studies on behalf of companies shall also notify the studies commissioned by their clients. This obligation concerns not only the laboratories based in the European Union, but also those in third countries that have an agreement with the European Union. This is a crucial point inasmuch as as any failure to notify a study will lead to the resubmission of a new dossier with a penalty of six months for its assessment. Once the file has been submitted, EFSA ensures that all the noti- fied studies are present. Otherwise, the procedure is suspended for six months pending the submis- sion of a new dossier. Once this step has been completed, the Agency shall make public the non-confidential version and all the notified studies. noitalsigeL — noitatnemelgèR- 86 -