European Parliament adopts new legislation on transparency, reforming the EU’s General Food Law

On 13 June 2019, the European Parliament formally adopted a new Regulation on the transparency and sustainability of the EU risk assessment model in the food chain. Based on a 2018 proposal tabled by the European Commission, the new Regulation mainly amends General Food Law Regulation (EC) No. 178/2002 and will give the public access to all studies and information submitted by industry in the risk assessment process. Furthermore, stakeholders and the general public will be consulted on submitted studies. Applicants may request that EFSA keeps some information confidential if it is not relevant to the assessment of safety and if they can justify that disclosing it may harm their commercial interests.

“The new Regulation brings significant change for not only the food industry, but also food packaging manufacturers and the crop protection sector,” says Mike Carroll, Principal Plant Protection Consultant, TSG Consulting. “From March 2021, the complete reports of all scientific studies reviewed by EFSA will be publicly available, unless EFSA grants confidential treatment in cases where an applicant can demonstrate that disclosing certain information will harm its commercial interests. The changes also affect the renewals of authorised substances that are already on the market. For these, applicants will need to notify EFSA in advance of the studies it plans to carry out for the renewal request, along with the proposed study design. Confidential business information and trade secrets will now be a privilege and not a right as they are today.”

The new Regulation has been implemented in response to EU citizens’ concerns over the transparency of scientific studies in the food area. Amendments have been made to eight legislative acts, dealing with specific sectors of the food chain: GMOs (cultivation and for food/feed uses), feed additives, smoke flavourings, food contact materials, food additives, food enzymes and flavourings, plant protection products and novel foods.

In addition to publishing scientific data, other measures to ensure a more robust, independent and transparent risk assessment process include: the creation of a database of commissioned studies and an obligation for applicants and laboratories to notify the database when studies are commissioned; a specific procedure for the renewals of already authorised substances; pre-submission advice on the applicable rules and the required content of an application dossier; fact-finding missions by the EC to ensure the compliance of laboratories and studies with standards; and the possibility for the EC to ask EFSA to commission studies to verify evidence used in its risk assessment policies.

The new Regulation is expected to be published in the Official Journal on 6 September 2019 and will enter into force by the end of March 2021.

Detailed information can be found in the European Commission Fact Sheet: New legislation on transparency and sustainability of the EU risk assessment model in the food chain