EFSA Guidelines bonanza: how to smoothly navigate the new transparency requirements?Posted: March 26, 2021 | |
The world of food is changing at a rapid pace – alternative proteins becoming a new reality. Examples are products using microbial fermentation or cellular agriculture in their production process. If you are a company wanting to market such a product in the EU, there is a good chance you require a prior market authorization as a regulated product, such as a novel food (NF) or a GMO. In that case, you need to get up to speed with the following four new ESFA guidance documents that will all apply as of 27 March 2021.
- Decision laying down the practical arrangements on pre-submission phase and public consultations
- Decision of EFSA’s executive director laying down practical arrangements concerning transparency and confidentiality
- Administrative guidance for the processing of applications for regulated products (update 2021)
- ESFA’s catalogue of support initiatives during the life-cycle of applications for regulated products (update 2021)
Document # 3 explains EFSA’s workflow in dealing with regulated products. It applies to applications for authorization of substances used in food and feed, food contact materials, NFs and GMO’s amongst others. The title of document # 4 is pretty self-explanatory. Examples of EFSA support initiatives range from general pre-submission and renewal advice to admin support to SMEs on applications and from EFSA guidance documents and scientific opinions to roundtables with industry associations.
Documents # 1 and 2 contain practical arrangements for companies that intend submitting scientific evidence regarding products requiring an EFSA evaluation. The full list of products is enumerated at the end of this post.* From a legal point of view, these guidelines implement the changes introduced in the General Food Law Regulation by the Transparency Regulation. We already covered the consequences of this Regulation in a previous blogpost, which in particular focuses on the relation between transparency and confidentiality.
This blogpost provides more detailed information on two topics representing a real change in the situation before 27 March, notably the general pre-submission advice and the notification of studies. To make this blogpost more concrete, it will target one specific category of regulated products within EFSA’s remit, notably NFs. For a reason. Currently, a great number of EU food companies active in the field of cultured meat are preparing their novel food applications. These companies need to be aware of these changes in the current regulatory framework.
General pre-submission advice (GPSA)
The GPSA to be provided by EFSA Staff concerns the rules applicable to and the content required for the NF application prior to its submission. It explicitly does not cover the design of the studies to be submitted. Aspects going beyond information available in any guidance documents are out of scope of pre-submission advice. Examples are questions regarding hypotheses to be tested or risk management. Furthermore, said staff shall not be involved in any preparatory scientific or technical work that is (in)directly of relevance for the NF application to be made. Also, the advice given shall be without prejudice and non-committal as to any subsequent assessment by EFSA (and the Member States via the PAFF Committee).
Prior to obtaining any GPSA, the applicant (and / or its representative) must register in the EFSA system supporting pre-submission activities and it must also request a pre-application ID. The pre-submission request can be introduced at any time before submitting a NF application. The European Commission nevertheless recommends submitting a request at least six months before introduction of the intended NF application.
The request for pre-submission advice shall be made in a dedicated form (“general pre-submission advice form”) made available by EFSA and a link should be made to the pre-application ID. Subsequently the applicant for an authorisation of a NF should provide all necessary information regarding the application, including a list of exhaustive questions. A maximum of two requests may be submitted under the same pre-application ID.
After a check that the questions asked are not out of scope, the applicant will be informed within 15 working days from the receipt of the advice form whether the submitted request is accepted or rejected. Companies expecting face-to-face meetings with EFSA need to know this will not happen automatically. Where possible, EFSA shall address the queries in writing. However, if EFSA considers that a discussion with the applicant might be useful to clarify certain aspects of the request, a meeting shall be organised. You then do not need to travel to Parma or elsewhere, as such meeting shall be conducted preferably by telco or webco. Only in exceptional cases a live meeting shall take place.
Any requests to be delt with in writing shall be answered within 15 working days after acceptance of the request. Any meeting to be set up shall be organised within 20 working days after acceptance of the request. EFSA shall draft a summary of the questions asked and not only send this to the applicant, but it will also publish it after the novel food application at stake has been considered admissible or valid.
Notification of studies
For transparency purposes, EFSA has established a database of studies commissioned or carried out by business operators to support any application requiring any type of scientific output, including a scientific opinion. The obligations to submit information on studies applies to both (A) potential applicants (i) having commissioned to a lab or external testing facility or (ii) carrying out such studies in in-house testing facilities and (B) to the labs or testing facilities carrying out such studies. Don’t be fooled by the wording “studies carried out” in relation to the notification required. In fact, timing is of the essence here, as all study notifications need to be submitted before the actual starting date of the study.
There may be justified justifications for not timely notifying studies. However, if EFSA does not consider the justifications provided by an applicant valid, the application needs to be re-submitted. As a consequence, the assessment of the validity of the application shall commence only six months after the notification of the studies according to the Transparency Regulation. The EFSA pre-submission guidance states the assessment of a re-submitted application shall commence 6 months after the re-submission of the application. This is not exactly the same, but it is clear that not complying with the studies notification requirement can be a serious showstopper, as a NF application supported by not-notified studies is not valid.
What exactly needs to be notified in the EFSA studies database? First of all, the study title, as well as an English translation thereof if the original title is not in English. Secondly, the applicant needs to be identified, after having first registered in the EFSA system for pre-submission activities. Thirdly the planned study starting and completion date, the laboratory where the study shall be carried out, as well as the study scope. In order to detail the study scope, the applicant should provide information on the intended study area (e.g. cultured meat), the study type (e.g. genotoxicity in vitro study) and the study objective (e.g. demonstrate that cultured meat does not pose any safety risks at the anticipated level of intake). The data entered can be modified, for instance if a study is delayed, the anticipated completion date can be aligned thereto. Information previously entered into the study database can also be withdrawn, but the applicant needs to provide a valid justification for that purpose. In the absence thereof, the same consequences will apply as when the applicant notifies its studies too late.
Once EFSA has received a valid or admissible application for a NF authorization, it shall publish this in order to launch the consultation of third parties on the application submitted. The rationale behind is that EFSA needs to have access to all relevant scientific data and studies available on the subject matter regarding the application at stake. Any communications on such consultation shall be published at EFSA’s website and shall remain open for three weeks, unless specified otherwise in sectoral Union law. For applicants, it is good to know that this public consultation in principle does not result in long delays. Upon closure of the public consultation, EFSA shall make publicly available all comments received. This will be done simultaneously with the publication of EFSA’s scientific output, which will address all relevant comments received.
What learnings can be drawn from the new EFSA Guidance documents? In the first place, that designing a safety evaluation strategy for a regulated product such as a NF has become even more important. By deciding as early stage as possible, what studies will be required to demonstrate the safety of your product, the chances that you can timely notify these studies in the EFSA study database shall increase. In this way, unnecessary delays in the appraisal of your application can be prevented. In the second place, it remains to be seen how helpful EFSA pre-submission advice will be, as it will be purely procedural and not material at all. At the same time, EFSA launched the new initiative of dedicated support for SME’s. Potentially, combination of the two reveals to be helpful.
*Products subject to transparency requirements and requiring an EFSA evaluation are the following:
- GMO’s (captured by both Directive 2001/18 and Regulation 1829/2003)
- Additives in animal nutrition
- Smoke flavouring used on food
- Food contact materials
- Food additives, enzymes and flavourings
- Plant protection materials
- Novel Foods