The U.S. and other companies that export foods, additives, colorings, etc. to the European Union (EU) should take notice: new legislation applicable to the agri-food industry is being billed as one of the world’s “most transparent” laws raising potential concerns about protecting proprietary information from competitors. Controversy surrounding the use of genetically modified organisms and the associated herbicide glyphosate paved the way for a European citizens’ initiative, which ultimately led to a legislative proposal by the European Commission to enhance public confidence in risk assessment of foods. The ensuing regulation on the transparency and sustainability of the EU risk assessment in the food chain will amend the EU’s General Food Law Regulation, a law that was adopted following a series of food incidents in the late 1990s.
The revised regulation aims to ensure that market approvals related to the food chain by the European Food Safety Authority (EFSA) are founded on reliable, objective and independent studies and risk analysis. It will entail automatic publication of all studies and information submitted to EFSA to support the authorization of a proposed product or ingredient. It appears that this data will be uploaded early in the approval process, a decision opposed by industry groups. In addition, the law will establish a database of studies for EFSA to verify whether all relevant research on a substance is considered in evaluating market applications. The intent is to deter corporations from withholding unfavorable data. In addition, stakeholders and the general public will be invited to join consultations to help identify any omitted information and ensure EFSA’s comprehensive access to evidence.
For obvious reasons, negotiation of the new legislation was plagued by thorny issues around business information as the legislators struggled to strike a balance between the protection of intellectual rights and commerce and exposing business secrets in a more transparent risk assessment process. The final acquired text is not yet publicly available but it appears that confidentiality of information will be able to be maintained where companies provide a “verifiable” justification for doing so. According to a document reportedly seen by Politico, companies will be able to seek confidential treatment of information on: “the manufacturing or 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 which is relevant to the assessment of safety.” The revised regulation requires formal approval of the European Parliament and the Council of the EU. It is scheduled to take effect 20 days after its publication, however, operative provisions will be delayed for some time to come.