Jeannette Paulussen, PhD, Willemien Wieland, PhD
Sweeping Changes in EU Food Safety Regulations
European regulation on transparency in the food chain: Opening up
On March 27, an unprecedented new law spanning all sectors of the food chain went into effect in Europe. The Regulation (EU) 2019/1381 introduces new rules for petitioning the European Food Safety Authority (EFSA) and amends the General Food Law from 2002. To put into perspective how expansive this law is, this is the first time that all studies on food safety will become available in the EFSA data base and the study summaries become publicly available.
The law affects registrations of feed additives, smoke flavourings, food contact materials, food additives, food enzymes and flavourings, GMOs (cultivation and food/feed uses), plant protection products and novel foods.
The impetus behind these amendments to the General Food Law Regulation of 2002 is to increase the transparency of the EU risk assessment in the food chain. In addition to increasing the transparency of risk assessments in the food chain in the EU it aims to strengthen the reliability, objectivity, and independence of the studies used by the ESFA. However, it may also lead to more confusion than clarity, at least at first.
More publicly available data under Food Safety Law
To meet these new regulations, a risk assessment will still be required that considers two main concerns:
- How hazardous the substance is: Is the substance toxic to the environment? Can you get an allergic reaction after repeated exposure?
- How the product is used: How much of the substance will get into the environment? How many times and how much exposure to farmers and consumers might occur?
What is different is the amount of data available to the public. Up until now only a summary of the risk assessment was made available, which included the conclusion, key data and considerations used to reach the conclusion. This lack of transparency may have led to a feeling of distrust and suspicion that companies were only including data favorable to their active registration.
To provide greater transparency in the processes leading up to approval of a substance, the new legislation foresees (among other things) that all test work should be notified to EFSA prior to initiation. This approach is expected to lead to increased reliability, objectivity and independence of studies used by the EFSA in its risk assessment.
The notification of any experiment performed will need to be done by the company commissioning the study before it even begins. When a CRO performs a study, it will need to co-notify the study, too. The platform to notify studies is now open and obligatory, and EFSA has made webinars available to indicate how to notify studies. However, the actual impact of the obligation to notify studies is not yet clear.
Furthermore, new studies required specifically for renewals of agrochemical actives need to be indicated up front in the EFSA database, so consultation from EFSA and the public is possible. The effect of this in time is unknown yet.
Ability to adapt to regulations will be key
In time more details from approved registrations will be made publicly available. The International Uniform Chemical Information Database (IUCLID) platform will need to be used to submit (renewals of) agrochemical actives. Registrations for other substances regulated under the Food Law will also need to be done via IUCLID. As for industrial chemicals registered under REACH this platform allows dissemination quite easily of non-confidential details, resulting in all data becoming publicly available.
When this will be done is not clear to date. The final update of the IUCLID form, which now includes summaries of the experimental data that need to be provided, was done only in the last week of March, but was obligatory the following week! My company (Charles River Labs), has >10 years of experience with the IUCLID platform and we therefore can adapt easily to these sudden changes, however for several companies and the member state authorities involved this is a whole new experience with a much bigger learning curve.
In addition, we expect these new regulations will cost time in the overall registration process and present a big hurdle toward approval of actives in general.
With that said, Charles River’s legal entities in the EU are all ready to co-notify studies to the EFSA database related to this regulation. In addition, we are following the developments closely, as not everything is crystal clear. Together with sponsors we will find tailor-made solutions on when and how studies are to be co-notified by Charles River, to make sure this is watertight. In this respect all cards are on the table: all studies need to be notified and the content of dossiers will be disseminated.