The EU Transparency Regulation – Potential Challenges for the Submission of Food-Contact Dossiers
The Transparency Regulation (EC) 2019/1381 introduced significant changes that impact petitions to the European Food Safety Authority (EFSA) for, amongst others, new monomers and additives intended to be used in the manufacture of plastic food-contact materials and articles and plastic recycling processes subject to authorization in the EU. The regulation, which applied from March 27, 2021, amended the EU General Food Law Regulation (EC) No. 178/2002 and impacted eight legislative acts across the agri-food industry, including the Framework Regulation (EC) No. 1935/2004 on food-contact materials and articles intended to come into contact with food.
Notably, the Transparency Regulation mandates that companies who intend to conduct analytical and toxicity studies to support petition dossiers for new food-contact substances or plastic recycling processes notify EFSA prior to initiating the studies. It also provides that a version of the petition from which confidential information has been redacted be published on EFSA’s website once the petition is officially accepted or ‘validated’ by EFSA. In addition, the Transparency Regulation details the type of advice that may be sought by applicants from EFSA officials prior to submitting petition dossiers to EFSA.
According to the European Commission (‘EC’), the Transparency Regulation aims at “increasing the transparency of the EU risk assessment in the food chain” and “on strengthening the reliability, objectivity and independence of the studies used by European Food Safety Authority”. However, the publication of scientific information and studies early in the risk assessment process is a significant confidential business information concern of U.S. companies registering products in the EU, points out the U.S. Department of Agriculture (USDA), Foreign Agricultural Service.
This article focuses on the aspects that may impact business operators in the food-contact sector.
Notification of Studies: What must be notified to EFSA prior to the submission of a petition dossier for a food contact substance or recycling process and what are the consequences of a failure to notify?
The Transparency Regulation requires EFSA to establish and maintain a database of studies carried out by business operators to support petitions to EFSA to provide a scientific output, including a scientific opinion (this is the case for monomers/starting substances and additives used in the manufacture of plastic materials and articles for instance). The Transparency Regulation further requires business operators, EU laboratories, and testing facilities carrying out testing intended to support a petition dossier for a food-contact substance or a recycling process to notify EFSA of such studies “without delay.” This includes in-house testing conducted by business operators to support such a petition dossier. This obligation is purported to apply to laboratories and other testing facilities located in third countries insofar as set out in relevant agreements and arrangements (although, to our knowledge, there are currently no such agreements in place).
The notification should include the following information:
- Title and scope of the study,
- Testing facility carrying out the study, and
- Commencement and planned completion dates of the study.
Importantly, the regulation provides that petitions for food-contact substances to EFSA are not to be considered “valid or admissible” if studies supporting the petition dossier were not previously notified to EFSA unless a valid justification for non-notification of such studies is provided. If petitions are deemed not valid due to a failure to notify studies, the studies in question would, thereafter, need to be notified to EFSA and the petition dossier could only be re-submitted to EFSA six months after the studies are notified.
A notified study can also be withdrawn before its planned completion date, but withdrawal of a notified study also requires justification or, again, the application may be deemed invalid by EFSA. If the application is deemed invalid for failure to include a notified study, the study would need to be notified and EFSA would only begin its review six months after the notification of the missing study.
Similarly, if in the course of a risk assessment EFSA discovers that studies subject to the regulation have not been notified and no valid justification was provided, the timeline for the risk assessment will be suspended, which will end only six months after the studies are notified. Hence, failure to comply with the notification requirement may result in significant delays of the petition dossier review process.
Pre-submission Advice: What does this cover?
The Transparency Regulation also provides that where EU law contains provisions for EFSA to provide a scientific output, including a scientific opinion, EFSA staff shall, at the request of a potential applicant, provide advice on the rules applicable to and the content required for the petition dossier prior to its submission. The advice may only include information available in the rules and guidance documents. For instance, “questions related to hypotheses to be tested or risk management shall be out of the scope of the general pre-submission advice.” EFSA recommends that requests for pre-submission advice be submitted at least six months prior to the targeted submission date of the application and a specific pre-submission advice online form must be used. A summary of pre-submission advice will be made public once the application is considered valid or admissible.
What Information can be maintained as confidential?
The Transparency Regulation requires that applicants file confidential and non-confidential versions of the food-contact petition dossier to EFSA where the applicant is seeking confidential treatment of parts of the dossier. The non-confidential version of the petition including relevant supporting documentation and any supplementary information supplied by the applicant will be made public by EFSA on its OpenEFSA Portal when a petition is validated or found admissible (i.e., at the initial stage of the risk assessment process). The Transparency Regulation identifies the following as details that may be marked as confidential in a petition dossier to the EFSA:
- Manufacturing/production process, including the method and innovative aspects thereof, as well as other technical and industrial specifications inherent to that process or method, except for information that is relevant to the safety assessment
- Commercial links between a producer or importer and the applicant, where applicable
- Commercial information revealing sourcing, market shares, or business strategy of the applicant
- Quantitative composition of the subject matter of the request, except for information relevant to the safety assessment
For food-contact petitions, the Transparency Regulation stipulates that the following additional details may be maintained as confidential:
- Any information provided in detailed descriptions of starting substances and mixtures used to manufacture the substance subject to the authorization; the composition of the mixtures; materials and articles in which the petitioner intends to use the substance; the manufacturing methods of these mixtures, materials, and articles; and impurities and migration test results, except for information relevant to the safety assessment
- Trademark under which the substance is to be marketed, as well as the trade name of the mixtures, materials, and articles in which it shall be used, where applicable
- Any other information deemed confidential in accordance with the specific procedural rules referred to in point (n) of Article 5(1) of the Framework Regulation
That said, the Transparency Regulation also states that where urgent action is essential to protect human health, animal health, or the environment, such as in emergency situations, EFSA may disclose the above listed information. Equally, if information forms part of the conclusions of scientific outputs, including scientific opinions delivered by EFSA, and which relate to foreseeable effects on human health, animal health, or the environment, it shall also be made public.
What happens if the EFSA and the Applicant disagree with respect to the information that may be maintained as confidential?
Following the publication of the non-confidential version of the petition, EFSA will then proceed with a thorough examination of all confidentiality requests. The Transparency Regulation sets out a detailed formal procedure to be followed in the situation where the petitioner/applicant disagrees with the EFSA’s assessment of what information may be maintained as confidential.
A number of databases have been up to implement the Transparency Regulation, notably:
“Connect EFSA” Portal: It is mandatory to register on the Connect EFSA Portal to obtain pre-submission identification and for pre-submission activities (i.e., notification of studies and to fill out the form requesting pre-submission advice).
“Food and Feed E-Submission Platform”: Petitions to EFSA for new food-contact substances or plastic recycling processes must be submitted via the Food and Feed e-submission Platform. This has been the case since March 27, 2021.
In conclusion, the Transparency Regulation has introduced substantial changes in the petitioning process to EFSA and it is important to become familiar with these to act in time, as a failure to do so could have significant consequences.
 Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain
See Official Journal of the European Union, 6 September 2019
 Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety.
 USDA, “European Union: EU Transparency Regulation Enters Into Force,” April 26, 2021. European Union: EU Transparency Regulation Enters Into Force | USDA Foreign Agricultural Service
 See Article 1 of the Transparency Regulation which inserts Article 32b in Regulation (EC) No. 178/2002
 For further details, please refer to EFSA’s Decision laying down the practical arrangements on pre-submission phase and public consultations
 See Article 1 of the Transparency Regulation which inserts Article 32a in Regulation (EC) No. 178/2002
 See Article 6, paragraph 2 of EFSA’s Decision laying down the practical arrangements on the pre-submission phase and public consultations
 See Article 1 of the Transparency Regulation which inserts Article 39a.1 in Regulation (EC) No. 178/2002
 See Article 1 of the Transparency Regulation which inserts Article 39.2 in Regulation (EC) No. 178/2002
 See Article 5 of the Transparency Regulation which inserts Article 20 in Regulation (EC) No. 1935/2004
 This refers to specific procedural rules that the European Commission could adopt in relation to the authorization of a new substance, process or material or article.
 See Article 1 of the Transparency Regulation, which inserts Article 39.4 in Regulation (EC) No. 178/2002