In 2019, the EU adopted Regulation (EU) 2019/1381, which introduced certain amendments to the EU General Food Law Regulation (EC) No 178/2002 (“GFL Regulation”), as well as certain other associated Regulations in the food space (e.g. GMOs, smoke flavorings, additives etc.), regarding e.g. risk communication, notification of studies, consultation of third parties and confidentiality. These amendments will enter into force on March 27, 2021.
The amendments were the result of public scrutiny over the risk assessment of certain products, such as GMOs and plant protection products. In January 2018, the Commission published its findings of the latest “Fitness Check” of the GFL Regulation and as a result of an ongoing public debate proposed certain amendments to the GFL Regulation with a view to increase the transparency and sustainability of the EU scientific assessment model. To that end, the revisions to the GFL Regulation include: a mechanism for pre-submission advice from the European Food Safety Authority (“EFSA”), the introduction of a database of studies commissioned by companies in support of an application or notification submitted to EFSA, a requirement for public consultations on renewal applications, as well as a mechanism for the Commission to request EFSA to initiate verification studies. Given the range of matters by EFSA, these changes will have implications for a wide range of companies operating in the space.
In preparation for the entry into force, EFSA has published Practical Arrangements on the interpretation of the transparency and confidentiality requirements, which set out EFSA interpretation of the new regime. EFSA has also updated its more scientific and administrative guidance documents to reflect the new transparency requirements. Further, EFSA also operates a specific mailbox for questions regarding the implementation of the new regime: TransparencyRegulationImplementation@efsa.europa.eu.
1. Pre-submission Advice
The new Article 32a GFL Regulation provides for a mechanism by which companies can seek scientific advice from EFSA in advance of the submission of application or notification. The provision makes clear that the EFSA staff involved in such pre-submission advice must not be part of the scientific or technical work undertaken in relation to a later application or notification to the extent that it relates to the subject matter of the advice. EFSA’s Practical Arrangements on Pre-Submission Phase and Public Consultations set out further details on pre-submission advice.
2. Database of Commissioned Studies
Under the new rules, EFSA has to establish and operate a database to record the studies commissioned or carried out by companies (or “business operators” in the language of the GFL Regulation) in support of their applications or notifications (new Article 32b of the GFL Regulation). The term “Study” is defined broadly as “an experiment or set of experiments in which a test item is examined under laboratory conditions or in the environment to obtain data with respect to the properties and/or the safety of that test item, which is relevant for submission to appropriate regulatory authorities” (Practical Arrangements on Pre-Submission Phase and Public Consultations), so will likely capture a range of activities.
Businesses operators must notify EFSA without delay, of the title and scope of any study commissioned or carried out by them to support any application or notification. They must also provide information about the laboratory or testing facility carrying out the study in question, and its start/end dates.
Under the same provision, laboratories and other testing facilities located in the EU also have responsibility to notify EFSA with the same information, as well as the name of the business operator commissioning the laboratory/testing facility. The disclosure obligations of Article 32b also apply to laboratories/testing facilities in third countries insofar as there are agreements and arrangements with those third countries.
Failure to notify EFSA of a study that is then relied on in an application can mean that the application is not considered valid or admissible, unless the applicant can provide a valid justification. Similarly, applicants must include supporting studies in their applications/notifications that have been previously notified to EFSA, unless there is a valid justification. These rules are intended to address past allegations that companies only submitted “cherry-picked” results to EFSA in support of their applications.
3. Disclosure of Supporting Information and Handling of Confidential Information
The new rules also require EFSA to make details of the studies notified to it available to the public, when it receives a corresponding application or notification. Under the amended Article 38(1)(c) GFL Regulation, EFSA must now make public “scientific data, studies and other information supporting applications, including supplementary information supplied by applicants…taking into account the protection of confidential information and the protection of personal data in accordance with Articles 39 to 39e.” The provision is without prejudice to existing EU rules concerning intellectual property rights, and EU data exclusivity rules.
The amended GFL Regulation allows applicants to request EFSA to grant confidential treatment to certain categories of information if they can demonstrate that disclosure would harm their interests to a “significant degree” (amended Article 39). The question of what constitutes a “significant degree” will likely be the subject of much discussion between companies and EFSA. One would expect that ultimately the European Courts will have to determine the boundaries. The new rules provide that certain information may be accepted as being confidential: the manufacturing or production process; commercial links between a producer or importer, or importer and applicant/authorization holder; commercial information revealing sourcing, market shares or business strategy of the applicant; and quantitative composition of the subject matter of the request. However, there are also certain caveats (effectively an exception from the exception). For example, the exemption for information regarding the manufacturing process and the quantitative composition is subject to an important qualification: if the information is relevant to the assessment of safety, it will not be granted confidentiality. EFSA’s Practical Arrangements concerning transparency and confidentiality set out details on the treatment of confidential information and specify the “substantive requirements (minimum content)” that companies need to meet in making confidentiality requests.
Finally, the provisions also make clear that EFSA can also choose to disclose this information in any event if urgent action is required to protect human health, animal health or the environment.
4. Public Consultations
New Article 32c of the GFL Regulation provides for the consultation of third parties (stakeholders and the public), once EFSA receives notification from applicants about studies commissioned for the renewal of an approval or authorization. Any consultation will cover the intended studies for renewal, including their proposed design. The consultation will be based on a non-confidential version of the application or notification “in order to identify whether other relevant scientific data or studies are available on the subject matter concerned by the application or notification.” Once comments are received from the consultation, EFSA will provide advice on the content of the intended renewal application or notification, as well as on the study design.
5. Verification Studies
The amended GFL Regulation will also allow the Commission in exceptional circumstances of “serious controversies or conflicting results” to request EFSA to commission its own scientific studies to verify evidence used in its risk assessment process (new Article 32d). The studies commissioned may have a wider scope than the evidence initially subject to the verification. The effect of this measure is likely to extend the timeline for any approval or authorization by EFSA while it carries out its own verification study. Moreover, the applicant will have no control over the manner in which the study is designed and conducted, thus taking the matter out of the hands of the applicant altogether. The question of when it will be appropriate to resort to such measures will likely give rise to much controversy.
6. The Future
The new transparency rules have raised significant concerns with many companies, especially regarding the early disclosure of studies. The amended text of the GFL Regulation states that public disclosure of applicants’ supporting information should not be considered as a permission or license to use, reproduce or exploit the relevant data or information in breach of any intellectual property rights or data exclusivity rules. At the same time, the provision also provides that the EU will not be responsible for the use of the disclosed supporting documentation by third parties. Further, EFSA must ensure that “clear undertakings or signed statements are given to that effect by those who access the relevant information prior to its disclosure.” Whereas food businesses used to consider patents as “nice to have,” it is likely that IP will soon play a much greater role in protecting innovation in the food space.
Covington has significant experience in handling transparency matters for clients in the pharmaceutical, food/feed, and chemical sectors. This includes several matters negotiating the scope of confidential information with the EU institutions and litigating against disclosure of trade secrets and confidential information in several cases before the EU Court of Justice.
If you have any questions concerning the material discussed in this client alert, please contact the following members of our Food, Beverage, and Dietary Supplements practice.
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