The General Food Law (GFL; (EC) No 178/2002) is the founding act of the current food and feed legislation. It lays down general principle, requirements and procedures related to decision-making in the food and feed safety in Europe. It also established the European Food Safety Authority (EFSA) and the basis of its functioning. It provides the legislative framework for a number of sub-areas, including Regulation 1831/2003 on additives for use in animal nutrition.
Based on a scheduled periodical “Fitness check”, but mainly driven by a controversy over the risk assessment of certain sensitive issues and a European Citizens’ Initiative entitled “Ban glyphosate and protect people and the environment form toxic pesticides”, the European Commission put forward a legislative proposal in order to increase the transparency and sustainability of the EU risk assessment in the food chain, which is amending the GFL. The announced purposes of the proposal were to improve citizens’ confidence in the credibility of the scientific studies and consequently confidence in the Union’s risk assessment, through improving public access to industry studies used by EFSA in its risk assessments. The proposal also seeks to safeguard EFSA’s ability to recruit scientific experts, what is understood to be increasingly challenging, and to reinforce the EFSA’s own scientific capacity.
In about a year from the initial proposal, through a first reading and an informal trilogue, the three institutions have reached an agreement on the proposal at a quick pace. Its final adoption by the Council occurred on 13 June and its publication is expected in September. Driven by legitimate principles of transparency, but missing to carry out an impact assessment, it is not certain that the co-legislators have fully encompassed the collateral consequences of the adopted measures, regarding market-access conditions that are already perceived as heavy by the economic operators.
It is not time anymore for feed applicant to worry about the decision made, but rather to adapt as quickly as possible to this new context with the least possible damage. Next chance to possibly influence the context will occur at the next 5-years periodical review of this Regulation.
The nature of the changes is fixed now; only the precise implementation calendar will be determined by the exact publication date. Most of the new measures will apply 18 months after the entry into force of this Regulation, so likely around April 2021. Considering the duration of the internal preparation of applications for feed additives, strategic adaptation to this new framework need to be put in place as soon as possible.
The main changes to take into consideration are the following ones:
- All studies submitted to EFSA shall be made public via the EFSA website (after the validity check).
- Standard data format for submission will be set
- EFSA is put in charge of decisions on confidentiality requests, under modified conditions and limitations (closed list of possible items)
- Public consultation on the dossier during the risk assessment
- A common European register/database of commissioned studies will be created (pre-requisite to applications)
- Public consultation on the planned studies for renewals at pre-submission phase
- Possibility for EFSA to commission additional studies (probably not relevant to feed additives applications)
- Possibility of pre-submission meeting with EFSA
- Changes regarding experts’ appointments in the scientific panels
- EC audits of the laboratories/facilities carrying out the studies
These different aspects might have significant consequences on the strategic planning of feed additives’ dossiers preparations and submission and should be carefully considered from the earlier stage of the process.