Written by Katia Merten-Lentz and Oliver Hartmann
At the beginning of this year, the Directorate General for Health and Food Safety of the European Commission (DG SANTE) published its findings in relation to the Fitness Check of the General Food Law Regulation (EC) No 178/2000 (GFL Regulation), which had been concluded by the end of 2017. Here, Katia Merten-Lentz and Oliver Hartmann at international law firm, Keller and Heckman, look at this check-up found shortcomings in transparency.
As the foundation of the EU’s food law, the GFL Regulation covers the entire food chain, notably all stages of production, processing and distribution of food and feed, including import – also known as the ‘farm to fork’ approach.
It contains general principles of food law, including the principle of risk analysis, making a distinction between risk assessment, risk management and risk communication and the precautionary principle, and general requirements of food law, such as food safety and traceability. Of course, the GFL Regulation also provides for the establishment of the European Food Safety Authority (EFSA).
The Fitness Check of the Regulation was conducted to evaluate whether the established general principles and requirements are appropriate for the purpose by identifying excessive regulatory burdens, overlaps, gaps, inconsistencies and/or obsolete measures.
In general, the REFIT evaluation found that the GFL Regulation remains relevant and has succeeded in achieving a high level of protection of human health and consumers’ interests in relation to food, while contributing to the effective functioning of the internal market.
However, certain shortcomings were identified.
One of the main findings regarding these shortcomings was the increased negative perception by the civil society of EFSA and its risk assessment process of regulated substances – such as, for example, enzymes, additives, pesticides or flavourings – based on studies financed by the industry. In particular, the findings emphasized in this regard that:
“[…]EFSA is bound by strict confidentiality rules that are laid down in the GFL Regulation and in the multiple authorisation procedures in EU secondary food legislation. The application of the confidentiality rules creates the perception of a certain lack of transparency. This perception is further reinforced by the civil society’s concerns over EFSA’s independence from industrial interests, as EFSA bases its risk assessment on authorisation dossiers on studies conducted by the industry. These criticisms in turn can have a negative impact on the acceptability of EFSA’s scientific work by the general public. There is therefore a need to address perceived issues with respect to the transparency as well as the reliability and independence of studies underpinning EFSA’s assessments […].”
Taking these findings into account, the Commission launched at the end of December 2017 the roadmap initiative “Transparency and sustainability of the EU risk assessment model in the food chain” .
A main objective of the initiative is to clarify and improve the transparency of the scientific studies supporting the risk assessment of substances subject to pre-market approval carried out by EFSA.
“One of the main findings was the increased negative perception by the civil society of EFSA and its risk assessment process of regulated substances based on studies financed by the industry”
By way of background, the GFL Regulation subjects EFSA to comprehensive transparency obligations, since its adoption in 2002, per Article 38.
As part of these obligations, EFSA is required to publish, inter alia, agendas, minutes and opinions of the Scientific Committee and Scientific Panels, the information on which its opinions are based, the results of its scientific studies as well as the annual declarations of interest of certain individuals from its staff.
Hence, “a high level of transparency” as formulated in Article 38 of the GFL Regulation is already being implemented in EFSA’s activities.
EFSA’s transparency obligation must be read in conjunction with Article 39 that lays down rules on confidentiality constituting a derogation from Article 38. In accordance with Article 39, EFSA may not disclose information, that was received and for which confidential treatment has been requested, to third parties.
This general provision of the GFL Regulation is complemented by confidentiality rules set out in sectoral EU food legislation such as Regulation (EC) No 1331/2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings. Of further relevance, Regulation (EC) No 1049/2001 regulates the right of access by the public to documents of the EU institutions and agencies, like EFSA.
On 11 April, the roadmap initiative resulted in the publication of the Commission’s legislative proposal on the transparency and sustainability of the EU risk assessment model in the food chain , amending principally the GFL Regulation and introducing, amongst other things, significant changes to rules on transparency and confidentiality under Articles 38 and 39. Besides the changes to the GFL Regulation, the Commission proposal amends, at the same time, relevant provisions of sectoral EU food legislation pertaining to GMOs, feed additives, smoke flavourings, food contact materials, food additives, food enzymes, flavourings, plant protection products and novel foods.
In particular, the proposal amends Article 38 by extending EFSA’s transparency obligations specifically to scientific data, studies and other information supporting applications for authorization of substances regulated under EU food law, including supplementary information supplied by applicants.
On this basis, EFSA is required to disclose scientific studies generated by the industry for the risk assessment of regulated substances. However, it is important that the obligation by EFSA to disclose such information does not affect any existing intellectual property rights and data exclusivity provisions established in sectoral food legislation. In addition, certain information may be protected as confidential in line with Article 39 as revised by the proposal.
Of relevance, the amended Article 39 restricts confidential treatment in principle to the following four types of information:
- the method and other technical and industrial specifications relating to the method, used to manufacture or produce the subject matter of the request for a scientific output, including a scientific opinion;
- commercial links between a producer or importer and the applicant or the authorisation holder, if applicable;
- commercial information revealing sourcing, market shares or business strategy of the applicant;
- quantitative composition of the subject matter of the request for a scientific output, including a scientific opinion.
When requesting confidential treatment of such information positively identified in the revised provision of Article 39, the respective applicant must still provide verifiable justification that disclosure significantly harms its (commercial) interests.
This approach adopted by the Commission could have repercussions for the promotion of innovation and stimulating research and development within the agri-food sector.
Interestingly, the amended Article 39 envisages that information may still be made publicly available, even if it is considered confidential, under the condition that urgent action is essential to protect public health, animal health or the environment, or that such information is part of the conclusions of EFSA opinions and relates to foreseeable health effects. In other terms, an overriding provision has been incorporated allowing for EFSA to disclose confidential information under certain circumstances.
Another novelty introduced by the proposal is that if an applicant requests confidentiality for certain parts of a scientific study generated, the applicant must submit a confidential and non-confidential version of the study concerned to EFSA. The Authority then publishes the non-confidential version of submitted study, while it will assess and decide on the confidentiality request for the identified information.
The proposal determines that the publication of the non-confidential version of the scientific study and the assessment of the confidentiality request must be conducted without delay by EFSA.
If EFSA takes the view that the confidentiality request cannot be supported, EFSA is obliged to inform the applicant of its intention to disclose the information and the reasons prior to taking the formal decision.
Following the notification of EFSA’s position, the applicant has the opportunity to state its views or withdraw the application. The next stage of this procedure, EFSA must adopt a reasoned decision on the confidentiality request taking into account the views of the applicant, where submitted within ten weeks from the date of receipt of the confidentiality request.
Consequently, any information for which the confidentiality request is considered not justified, would be made public, unless the corresponding application was withdrawn by the applicant before the decision on the confidentiality request by EFSA.
Openness of scientific studies
The tabled proposal demonstrates the Commission’s willingness to ensure that most of the content of the scientific studies provided by the industry for the risk assessment process are made public.
While intellectual property rights and data exclusivity provisions established in sectoral food legislation are still protected, the grounds for confidential treatment of information are narrowly defined so that the proposal restricts the possibility significant for the industry to keep information and data included in scientific studies confidential.
This approach adopted by the Commission could have repercussions for the promotion of innovation and stimulating research and development within the agri-food sector. More specifically, the extension of transparency and the restriction of confidentiality facilitates the publication of data submitted for the risk assessment of a regulated substance that could allow competitors of the given applicant to potentially use, one way or another, the generated data for the substance concerned without having to face the same costs and efforts.
In terms of next steps, the Commission proposal is submitted to the Council and the Parliament for review taking into account that the two EU institutions as co-legislators may table amendments to the proposal. It, therefore, remains to be seen to what extent the initial provisions of the proposal are kept.
This article was first published by EU Food Law on April 19, 2018.