On 6 September 2019, Regulation (EU) 2019/1381 of the European Parliament and of the Council on the transparency and sustainability of the EU risk assessment in the food chain (the “Regulation”) was published in the Official Journal of the European Union.
Review of the matters addressed by the Regulation was initially prompted by a European Citizens’ Initiative (#StopGlyphosate), which campaigns against the use of toxic pesticides and for reform of the EU pesticides approval procedure.
The new Regulation principally amends Regulation (EC) No 178/2002 laying down the general principles and requirements of food law (the “General Food Law Regulation”). It also amends eight sector-specific legislative acts, concerning genetically modified organisms, feed additives, smoke flavourings, food contact materials, food additives, food enzymes and flavourings, plant protection products and novel foods.
Disclosure of scientific assessments
Many food and feed-related products (including those covered by the legislation listed above) require a scientific assessment to evaluate their safety before they are authorised to be placed on the EU market.
The focus of the Regulation is to promote transparency within that scientific assessment process, to explain how risk management decisions are reached and to involve all interested parties (including consumers, feed and food businesses and the academic community) in the decision-making process.
The Regulation requires that information relied upon for the purposes of scientific assessments should be disclosed, subject only to protection of confidential information (explicitly defined and subject to determination by the European Food Safety Authority, EFSA) and personal data. These requirements shall not be considered to constitute a licence for the relevant data and information to be used in breach of intellectual property rights or data exclusivity rules, although it is unclear how such rights can be protected outside the EU where they may be eroded by the simple fact of publication.
Under the Regulation, the European Commission is required to adopt a general plan for risk communication, by means of implementing acts. This will promote an integrated risk communication framework to be followed at both EU and national level.
Database of studies to support an application or notification
The EFSA is charged with managing a publicly accessible database that will contain details of all studies and information commissioned or carried out by business operators to support an application or notification in relation to which EU law provides for any scientific output by the EFSA.
The Regulation establishes a notification obligation, to ensure that business operators, laboratories and other testing facilities notify EFSA of the title and scope of any such study, together with its starting and planned completion dates. All notified studies (including unfavourable studies) must be included in any subsequent application or notification to EFSA, unless non-inclusion is justified. The studies will not be made public until any application has been determined.
These changes will affect applications for new product authorisations, as well as renewals of authorisations of substances that are already on the market.
Under the Regulation, EFSA will also provide pre-submission advice on the applicable rules and the required content of an application dossier. That advice is particularly intended to benefit small and medium enterprises (SMEs).
The Regulation will become applicable by March 2021. However, companies with products that come within the scope of the Regulation will need to prepare for its entry into force by considering the nature of the studies they commission and the information included in those studies, bearing in mind the Regulation’s general principle of pro-active public disclosure of that information.