26 October 2021 - This year has seen dramatic changes to the regulatory environment for feed ingredients and feed additives in the EU, most notably the so-called “transparency regulation” which entered into force in March. Looming over the industry for the last two years, Regulation (EU) 1381/2019 overhauled how feed additives companies communicate with the European Food Safety Authority (EFSA) about studies and how EFSA communicates with the public about risk assessments, among many other changes.
Looking to help address some of the industry’s numerous questions about these changes, the regulatory experts of Pen & Tec Consulting will be leading a workshop at this week’s Feedinfo Summit in Geneva reviewing the first six months of the transparency regulation. Ahead of this widely-anticipated workshop, Feedinfo caught up with Pen & Tec CEO Dr. Hannah Lester to learn her views not only about the changes wrought by the transparency regulation, but also about other shifts in the EU regulatory environment which may reverberate for the animal nutrition industry for years to come.
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[Feedinfo] I know you will be talking extensively about the transparency regulation in your workshop at the Feedinfo Summit, but perhaps in the meantime you can share a more personal view of your and your teams’ experiences since the new regulation came into force. On the company/applicants’ side, has there been confusion or surprise about certain details of the new framework? And how have you found things on the regulators’ side: were they prepared for the implementation of the new regulation? Has the roll-out been as smooth as can be expected? Moreover, the EC & EFSA were also flooded with feed additive applications submitted before the 27th March deadline. Pen & Tec alone submitted over 30 dossiers. However, there have been some teething problems, including the following: |
Dr. Hannah Lester |
Technology-related problems
For example, with the EFSA Connect Portal, many of our clients have experienced difficulties setting up accounts, and in some cases this has taken several weeks.
Moreover, each business entity was allocated only three EFSA e-mail accounts initially (now increased to six), which caused administrative problems for organisations with teams of managers that need to access the system frequently. Sharing e-mail accounts causes problems with passwords & access to the system.
Additionally, EFSA realised after implementation of the EFSA Connect Portal that entities using the system may play multiple roles – Business Operator, External Laboratory/Testing Facility, Internal Laboratory/Testing Facility, Lead Applicant for a group of Applicants, Consultants, etc. The system was updated to reflect these different roles, but what the industry needs is for EFSA to publish clear guidelines about the procedure for notifying the list of intended studies for renewals when a consultant is acting as the Feed Business Operator (FBO) that represents a group of applicants.
There have been some updates on the platform that were implemented without prior notice; for example, the requirement of creating a relationship in the system before a consultant can notify studies on behalf of a FBO, or the change in the procedure for notifying the data of the CRO/lab where the studies will be performed (before we could do this while the study was still in draft mode, whereas now the information can only be provided immediately before notifying the study). However, some updates were announced before implementation, such as the introduction of a double authentication system, but this caused a lot of issues and many users were frozen out of their accounts.
Pre-submission advice
Pre-Submission Advice (PSA) is obligatory for renewal dossiers & requires pre-notification of intended studies (NoS – Notification of Studies). Some of our team and clients have found the system to be complex and have suffered IT glitches; when this happens, notifiers are unsure if the problems arising are due to this complexity and their own failure to use or understand the system correctly, or if it is a technical bug. Notifier questions to EFSA take significantly longer to process and generate a response than EFSA target timeframes, which is very frustrating for everybody.
In our experience with feed additive renewal PSA, EFSA is complying with the general timelines. However, files for the public consultation (EXCEL) are not available on the platform, even though EFSA says they are (i.e., when you click the link, you get an error, and EFSA only fixes this in the last days of the public consultation). But overall, EFSA still respects the timelines, closes the public consultation and provides PSA when it should.
Notification of studies
Regarding the notification of studies in general, there has been confusion about how to make notifications when multiple companies are developing a joint application. Furthermore, we are now in Q4 and find that studies which were apparently notified correctly are stuck in the system. Laboratories trying to co-notify find the “co-notify” button unresponsive. We have also heard that many companies are still not clear about the co-notification obligation for studies for labs/CROs located outside the EU for example.
And beyond…
A lot of emphasis was given to the portal for notification of studies (EFSA Connect Portal), but not to the other new platforms that applicants need to use for the registration process, such as the E-submission food chain platform and Portalino. We keep finding that companies do not even know they exist.
I think one of the trickiest areas is confidentiality requests – there is a lot of confusion regarding what can be requested as confidential, what justifications will be considered valid, and how to prepare the proper documentation to make a confidentiality claim. Additionally, the new requirements make this a very time-consuming process that applicants do not know until they start to work on the dossier.
It will just take time to get used to the new system and it is inevitable that there has been initial problems and confusion. EFSA staff are working hard to put everything back on track as soon as possible, & we all sympathise with the difficulties faced by the EFSA team.
[Feedinfo] Of course, as has already been pointed out, there has been quite a lot of discussion and coverage of the transparency regulation. Are there other developments in feed regulation in 2021 which have perhaps received less attention than they deserved?
[Hannah Lester] The transparency regulation has certainly dominated the regulatory world in the EU since it took effect in March. I think some public consultations have been overlooked, such as the recent update to the feed materials catalogue. Unfortunately, there was only a month to provide feedback and only seven responses were recorded.
[Feedinfo] In July, the EC adjusted its approach to feed additives and feed materials authorised for use in organic production, with changes to take effect in January 2022. Can you explain what changed, and how significant the move was?
[Hannah Lester] The implementation of the new organic legislation was indeed postponed for a year due to pressure from organic stakeholders. This pressure was related to the limited time that EU Member States had to properly discuss, finalise and implement secondary legislation, which would have left organic operators very little time to adapt to new rules had the regulation been implemented in January 2021.
The new organic regulation foresees the adoption and implementation of many delegated acts and implementing measures relating to technical rules such as organic production rules, group certification and the organic control system. Unfortunately, EU Member States did not manage to agree and finalise the complex secondary legislation in good time. The delay was also related in part to the COVID-19 crisis.
The postponement was widely praised by the industry. It was really good to see that the EC was open to the feedback from the industry and willing to delay implementation to give organic producers enough time to adapt and implement.
[Feedinfo] Policy frameworks like the Green Deal and Farm to Fork are lined up to transform food production in the EU. What kinds of effects are you expecting for the animal nutrition industry?
[Hannah Lester] I really hope that the EU uses this as an opportunity to create and invest in a more sustainable food chain. I hope that it will provide scope for innovation in the animal nutrition industry and be open to the use of new technologies such as cell-cultured protein. I also think it is an opportunity to register feed additives under the Zootechnical category, such as physiological condition stabilisers, that will help animals to be more productive without the use of antibiotics. I think there is real potential here as long as EFSA is open to applicants proposing unique methods of action and novel study designs & endpoints outside of the standard EFSA guidance.
[Feedinfo] Can you give an overview of the regulatory status of hemp-related ingredients in animal feed in Europe?
[Hannah Lester] Hemp seed, hemp seed oil and hemp expeller are all listed in the catalogue of feed materials and can be used as feed materials as long as the variety of hemp used contains less than 0.2% tetrahydrocannabinol. However, CBD is not authorized for use in feed either as a feed material or a feed additive. Several notifications have been made for CBD on the feed material register, but all have been rejected because CBD has been classified as a feed additive. Hence, CBD does not have a legal status for use in animal feed & will require a feed additive authorization most likely as a zootechnical additive. This is not stopping feed businesses though – many rapid alerts have been submitted by EU Member States this year notifying of the presence of CBD in complementary feeds, especially complementary feeds for pets.
[Feedinfo] Do you believe the animal production industry should be concerned about the EC banning the use of ionophores? Why or why not?
[Hannah Lester] This is a tricky question. I do not think we can take anything for granted.
The ionophores offer an effective solution for the control of coccidiosis, which is a devastating disease that has severe implications to the health and welfare of poultry. I have witnessed firsthand the rapid and fatal onset of this disease and once it is established, it is very hard to eradicate.
There are coccidial vaccines available, but they can be expensive and more complicated to administer.
In terms of the reasons for banning them, all coccidiostats are subjected to a rigorous safety evaluation by EFSA before they can be placed on the market and applicants must demonstrate that the product is safe for the target species, users, consumers, and the environment. Applicants must also demonstrate efficacy against recent field isolates of Eimeria spp.
The only reason that the EC would ban the use of ionophores is if there is a significant body of evidence to show that the ionophores are not safe for example, if they were in any way linked to antimicrobial resistance. There has been a lot of research conducted over the years on ionophores and no link between ionophore use and an increased risk of antibiotic resistance to antibiotics used in human medicine has been established. Moreover, ionophores are not used in human medicine and have a different mode of action to human antibiotics.
The good news is, EFSA has recently published opinions on ionophores and concluded that they are safe & effective & were subsequently authorized by the EU. There are several ionophore dossiers (renewal of authorization) still under review, although it is true that the applicants are having a hard time and have received many supplementary information requests.
Published in association with Pen & Tec Consulting