The European Commission has issued its much anticipated proposal on the transparency and sustainability of the EU risk assessment in the food chain. The proposal is of direct impact to companies regulated by eight pieces of existing EU sectoral legislation on: (i) the deliberate release into the environment of genetically modified organisms (GMOs), (ii) GM food and feed, (iii) feed additives, (iv) smoke flavourings, (v) food contact materials, (vi) food additives, food enzymes and food flavourings, (vii) plant protection products (agrochemicals), and (viii) novel foods. A key issue will be whether this initiative to increase transparency of the risk assessment process and facilitate public scrutiny will sufficiently protect the rights of information submitters to protect their confidential business secrets (one component which the Commission acknowledges as supporting innovation).
The proposal is part of the Commission response to a European Citizens’ Initiative submitted during the process for re-approval of glyphosate (an active substance used in plant protection products). It also responds to “public controversy over the approach towards the assessment and management of sensitive substances such as genetically modified organisms, and plant protection products” more generally, and “potentially negative health impacts arising from endocrine disruptors.” This is the first stage of a full legislative process.
Strong Political Push
The Commission first indicated that it would come forward with a proposal in December 2017. A public consultation was initiated in late January 2018. The full proposal has been issued a mere 56 days after the closing of a public consultation - in which some 471 stakeholder submissions were provided. No Impact Assessment has been carried out by the Commission. These are required under the Commission’s 2017 “Better Regulation Guidelines” for “…Commission initiatives that are likely to have significant economic, environmental or social impacts.” The Commission has apparently concluded that there will be no significant clearly identifiable impacts. The compressed timeline reflects a high-level commitment to this initiative within the Commission.
Rules on Confidentiality
The proposal envisages an alignment of rules on confidentiality and disclosure for all information which will be submitted to EFSA. It establishes a list of information for which confidential treatment could be claimed, based upon “verifiable justification” that disclosure would “significantly harm the interests concerned”:
- the method and other technical and industrial specifications relating to that 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, where applicable;
- commercial information revealing sourcing, market shares or business strategy of the applicant; and
- quantitative composition of the subject matter of the request for a scientific output, including a scientific opinion.
For each of the eight pieces of existing EU sectoral legislation, the proposal lists additional information which EFSA “may also” treat as confidential based upon the same “verifiable justification.” These should be studied carefully by each concerned sector.
It is unclear where the “significantly harm” test, for justifications, comes from. It sets a very high threshold. All other information in the EU, under the Regulation (EC) 1049/2001 on access to documents, applies the more nuanced standard that disclosure “would undermine the protection of commercial interests.”
Confidentiality claims would need to be submitted to EFSA along with an application for an authorisation, supporting scientific data and other supplementary information. EFSA would make a concrete and individual examination of the confidentiality request in each case. Thereafter the following procedure would apply:
- EFSA would inform the applicant in writing of its intention to disclose information and the reasons for it (a draft decision), before taking a formal decision on the confidentiality request. This provides an opportunity for the applicant to state its reasons for disagreeing or withdraw its application within two weeks from the date on which it was notified of EFSA’s position.
- EFSA would adopt a final decision on the confidentiality request, within ten weeks from the date of receipt of the request. These decisions would potentially be challengeable before the Court of Justice of the European Union (and an application for injunctive relief could be made as well). Non-confidential information would be made public.
EFSA would also undertake a review of the confidentiality of information previously granted confidentiality protection, when it issues its scientific outputs (including scientific opinions). A concrete individual decision would be taken by EFSA (as outlined above).
The proposal stresses that disclosure of information to the public would “not be considered as an explicit or implicit permission or license for the relevant data and information and their content to be used, reproduced, or otherwise exploited and its use by third parties shall not engage the responsibility of the European Union.” This appears to be an attempt to affirm that information owners retain the ability to insist upon financial compensation for any citation rights which they may grant to third parties (or are required to grant, where sharing is mandatory). This is welcome in the EU but is unlikely to be sufficient. The real commercial impact of disclosure of information is likely to be felt outside the EU, where national data protection and confidentiality regimes (in so far as they exist) are not bound by EU law.
Register of Studies
To address the claim that EFSA makes assessments without having the whole picture:
- business operators would have an obligation to notify, without delay, the subject matter of any study commissioned to support a future application for an authorisation under EU food law; and
- laboratories carrying out those studies in the EU would have the same obligation.
The consequences of non-compliance would be set out in EFSA’s internal rules. Notifications would be made public in a register “only in case a corresponding application for authorisation has been received” and “after” it “has decided on the disclosure of the accompanying studies” in accordance with EFSA’s transparency and confidentiality rules, outlined above.
Potential applicants for renewals would have to notify EFSA of the studies they intends to perform. In response, EFSA would:
- launch a consultation of stakeholders and the public on the intended studies (after it has decided on disclosure, in accordance with EFSA’s transparency and confidentiality rules); and
- provide non-binding advice on the content of the intended renewal application taking into account the received comments.
The stated objective of this consultation is to facilitate the identification of “other relevant scientific data or studies…available on the subject matter concerned.” It is to be hoped that this might stop some stakeholders from trying to derail authorisation processes by producing last minute, allegedly new and relevant, information.
Study Controls and Verification
Two measures aim to ensure confidence in decision-making, whilst retaining the burden of proof on the dossier submitter to demonstrate safety:
- “Commission experts” would acquire the power to “perform controls, including audits, to obtain assurance that testing facilities comply with relevant standards for carrying out tests and studies.” This would be done in cooperation with member state competent authorities.
- EFSA would acquire the residual power - “in exceptional circumstances” - to commission scientific studies “with the objective of verifying evidence used in its risk assessment process.” These could have “a wider scope than the evidence subject to verification.”
EFSA is already charged with communicating about risk to “promote coherence,” in cooperation with the Commission and member states. This includes explaining risk assessment findings and the basis of risk management decisions, as well as distinguishing between hazards and risks and addressing risk perceptions “in order to improve consumer confidence.” The proposal aims to strengthen this role by establishing:
- harmonised risk communication objectives, including to “foster public understanding of the risk analysis process so as to enhance confidence in its outcome” and “promote consistency and transparency in formulating risk management recommendations”; and
- general principles of risk communication, including to “take into account risk perceptions” and to “be accessible, including to those not directly involved in the process, while taking into account confidentiality and protection of personal data.”
Moreover, the proposal would empower the Commission to adopt “delegated acts” to establish a general plan for risk communication on matters relating to the agri-food chain, within two years from the date of application of the proposal. The delegated acts procedure provides for discussion with member states and possibly stakeholders. However, it does not require a voting procedure by any committee in order for the Commission to adopt (unlike other “comitology” procedures). The European Parliament and member states retain the ability to object - a “nuclear option” - in which case the measure would not enter into force.
The Management Board would be transformed from its current 14 member state nominees, to 34 sitting members from a wider range of backgrounds:
- 27 members nominated by member states (plus alternatives when necessary);
- 2 members from the Commission (plus alternatives when necessary);
- 1 from the European Parliament; and
- 4 representing civil society and food chain interests (1 from consumers organisations, 1 from environmental NGOs, 1 from farmers organisations and one from industry organisations).
All of these would have the right to vote, by majority voting in most cases. It is striking that the Commission, which plays a distinct risk management role, would be given voting rights regarding the running of EFSA, the independent risk assessor.
The Scientific Panels would be strengthened by measures which aim to ensure a wider pool of independent experts as candidates. Each Member State would nominate at least 12 scientific experts and each panel would be allowed to have up to 21 members. They would serve 5 year renewable terms (increased for the current 3 year term). EFSA’s Executive Director would draw up a list of experts for each Scientific Panel, based on new criteria, which would be appointed by the Management Board.
EFSA’s Working Methods
EFSA has been under sustained attack from some stakeholders about its independence. This has sometimes led to a regrettable reluctance to engage with dossier submitters, for fear of being perceived as lacking independence. The proposal would address this issue by setting out a transparent “pre-submission procedure,” by which EFSA can provide advice to an applicant. In the case of renewals, the pre-submission procedure foresees that studies planned by a potential applicant would have to be notified to EFSA and, after public consultation on these planned studies, EFSA would systematically provide advice to the applicants.
The Commission will want to have the adoption process completed before the current European Parliament’s term of office expires in May 2019 – if agreement can be reached between Parliament and the Council of the EU (member states). The timeline for action is short. If adopted, the measure would come into effect (with some transitional arrangements) 18 months after its entry into force.
Stakeholders should begin participating in the legislative process - analysing the impact of the proposal and expressing their views and suggestions - immediately. Whilst the proposal is of direct importance to companies regulated by eight pieces of existing EU sectoral legislation, its impact is likely to be felt beyond these areas. Other bodies in the EU carry out risk assessments and the pressure to align should not be underestimated. Equally, its effects may be felt beyond the territorial borders of the EU. Some aspects of the proposal may impact rights currently enjoyed by companies operating from within the EU’s trading partners. Discussions on this proposal are sure to be lively.