EU food safety proposal: changes to risk assessment, but not FBO responsibility

Published 28 November 2018 in Agribusiness Intelligence and reprinted with permission

In April 2018, the European Commission officially proposed a targeted revision of the General Food Law Regulation (EC 178/2002) to improve the transparency of scientific studies in the food safety area, writes  international food law firm Keller & Heckman.

This proposal follows a European Citizens' Initiative submitted in October 2017 focusing on pesticides and food safety.

However, the main principles of food safety in the EU, i.e. responsibility of the operator and traceability, will not be part of this revision.

The Commission recently explained in its answer to a parliamentary question that the current framework had resulted, globally, in positive outcomes and did not have to be amended for now.

Keeping the preventative approach

European food safety regulation is primarily based on a preventive approach, in which food business operators (FBOs) hold the primary legal responsibility for ensuring compliance with food law.

The legal framework results from two main instruments combined:

-        the General Food Law Regulation (GFL), which lays down the general principle that all operators in the supply chain may only place safe foods on the market; and

-        the EU Regulation (No 852/2004) on the hygiene of foodstuffs.

The EU Regulation on hygiene states that FBOs must implement a food safety management system, which prevents and reduces food-borne hazards, and which is based on the hazard analysis and critical control point (HACCP) principles.

These flexible principles are developed to enable operators to identify points during the production where potential hazards may occur (related to harmful microorganisms, chemical hazards, packaging or equipment quality, etc), analyse the probability of those hazards happening, and set up controls and corrective actions to tackle them, such as sampling the food to check microbiological criteria for instance.

The Regulation on hygiene also provides a set of rules on good hygiene practice, covering aspects like cleaning and disinfection, pest control, waste management, hygiene of the staff and transport.

Operators must also ensure that products comply with specific EU provisions on safety, such as the regulations setting up maximum levels for certain contaminants and residue levels of pesticides in food, beyond which a food may not be placed on the market.

If despite the preventive measures, an unsafe product is placed on the market, the GFL Regulation provides for additional dispositions to protect the safety of consumers.

The GFL imposes general obligations on food business operators in terms of traceability, notification of food safety incidents and withdrawal and recall of unsafe food.

The obligation of ‘traceability’ means that the operator must be able to identify both their suppliers and customers through all stages of production, processing and distribution. Traceability is essential to facilitate withdrawal and recall of food.

Indeed, if an operator believes that a food that it has imported, manufactured or distributed is not in compliance with food safety requirements, he or she must withdraw it immediately, by removing it from the supply chain. If this product might have been already bought by consumers, it has to be recalled in addition. The FBO also has to notify the national authorities of the withdrawal as soon as possible.

When a serious health hazard is detected, the national authorities inform the European Commission and the other Member States via a platform called the Rapid Alert System for Food and Feed.  If deemed necessary, the Commission can adopt emergency measures - such as suspending the placing on the market of products - to mitigate the risks.

Reform on transparency of the risk assessments for food-related authorisations

After completing, in January 2018, the REFIT on the GFL Regulation, the Commission concluded that the core principles regarding risk analysis, primary responsibilities of FBO and traceability, have been successful in protecting public health.

However, the Commission noted a lack of trust from the citizens regarding transparency of risk analysis, particularly with regard to the authorisation dossiers.

While on the one hand the operators are responsible for the safety of the products they put on the market, on the other hand, the European Food Safety Authority (EFSA) plays a major part by assessing the dossiers submitted by operators seeking authorisation for novel foods, additives, plant protection products and food improvement agents.

The GFL Regulation lays down that EFSA's assessment is primarily based on industry studies - therefore generated by the applicant. Moreover, EFSA is bound by strict confidentiality rules with regards to these studies. These elements have a negative impact on consumers' trust. To tackle this issue, the Commission has made several proposals to ensure more transparency during the risk assessment process.

The reform proposes free access for citizens to all safety-related information submitted by the industry, and the creation of a European Register of studies.

The proposal also includes consultation of stakeholders and public on studies submitted by the industry, as well as an increase in the EU member states' involvement in EFSA. Finally, the Commission also wants to strengthen risk communication to citizens by promoting public awareness and better explaining scientific opinions.

The proposal is currently being examined by the European Parliament in the first reading, and the main sticking point in the discussions relates to the level of confidentiality that must be granted to industry studies.

The first trilogues are expected late December and early January, which means that the reform will probably be adopted during the course of 2019, but certainly not under the current Parliament.