The Evolution of the Official Controls System: A “One Health” Strategy│Italy

The system of official controls within the EU continues to develop as a result of the new Regulation (EU) 2017/625 (the “Regulation”), which – unlike Regulation (EC) No 882/2004 – brings a highly innovative perspective to the primary legislation contained within Regulation (EC) No 178/2002. The main areas in which the system has evolved include the new rating scheme and integrated information processing system, as well as the updated definitions of “risk”, “hazard” and “operator”.

Regulation (EU) 2017/625 (“the Regulation”) introduces a more organic regulatory framework for official controls, with a wider scope of application compared with previous EU legislation. The Regulation encompasses official controls concerning all food and feed enterprises, from primary producers to retailers and restaurateurs – including selectors, farmers, livestock breeders, and traders of animals and plants.

The Regulation has an integrated approach that covers the following areas:

As such, the Regulation represents a legislative mindset regarding official controls that is characterised by a One Health approach. In other words, the Regulation lays down a legislative framework that includes the protection of other factors that are crucial for food health and safety, as well as those historically connected to human health. There has been a shift, therefore, from a human-centred view of risk protection to an approach that extends its focus to the environment of which humans are a part.

This new approach led to a significant change in the legal definitions of “risk” and “hazard” – not to mention the very meaning of “operator” – and, in doing so, partly implied a repeal of previous definitions under Regulation (EC) 178/2002. Specifically, the current definitions of “risk” and “hazard” also take into account detrimental effects on animal health, animal welfare (including during the transport, slaughter, and breeding stages), plant health, and the environment (with regard to GMOs and plant protection products).

As previously mentioned, this framework also includes changes to the definition of a “food business operator”, which was previously based on Regulation (EC) 178/2002. Pursuant to Article 1.2 of the Regulation, FBOs are now simply “operators” – ie, natural or legal persons whose business activity is not limited just to the food industry but also covers areas such as animal welfare and the environment, which were only involved in their activities in intersectoral terms (and not very explicitly) under previous legislation.

In light of the foregoing, it appears clear that the official controls system changed its approach to move towards a “wholesomeness” of food safety, as defined under Article 1 of the Regulation.

In terms of regulatory changes, it is worth noting that the frequency of official controls has been deemed “appropriate” in accordance with Recital (32) of the Regulation, which introduced a definition rooted in a “risk approach” – meaning that official controls should be carried out based on risk. The definition of “appropriateness” in the context of the frequency of official controls is measured based on the risk of an operator’s activity and possible violations of the relevant legislation perpetrated by the operator.

According to the Regulation, the results of official controls should be recorded using a “rating” scheme, meaning a system based on the assessment carried out at the premises of operators during official controls. The classification should be based on an assessment of the operator’s conformity with certain criteria (known as “ratings criteria”), which must be established in a fair, consistent, transparent, and objective manner by single EU member states. From the operator’s standpoint, the implementation of a rating scheme may be beneficial for two reasons:

Another relevant change is the Regulation’s focus on the manner in which official controls can be performed. Specifically, the Regulation confirms that official controls can be performed “without notice” and introduces the option for competent authorities to perform controls “through remote means”. The performance of remote official controls allows the competent authorities to obtain samples by “mystery shopping” – ie, placing anonymous orders for products, which can then be analysed, tested or subject to a verification of compliance. However, it is worth noting the defence guarantees accorded to operators during “physical” and contextual inspections must always be in place. For this reason, the collection of samples should be conducted with special care.

As well as making a legislative commitment to establishing a harmonised system for organising official controls, the Regulation also introduces a new computerised system for processing information and documents pertaining to official controls and other official activities in EU member states. The Regulation introduced this system, known as “IMSOC (Information Management System for Official Controls)”, under Articles 131 et seq. However, the specific rules for the operation of the system were only laid down by Implementing Regulation (EU) 2019/1715.

The IMSOC integrates the four systems already in place and managed by the EC, namely:

The purpose of this integration is to guarantee an improved merging of information from the various systems to prevent – or at least identify – any risk situations with ramifications in more than one EU member state. The IMSOC Implementing Regulation also introduced changes to the structure of the RASFF (now iRASFF) by adding:

The above-mentioned considerations reflect only a few of the Regulation’s main points and, as such, this article is not intended as a comprehensive analysis. The development of the Regulation is still “unfinished”, both at a national and EU-wide level. From the standpoint of single member states, the Regulation still requires implementation measures to apply the principles and procedures it lays down. Meanwhile, implementing and enforcement regulations will require further deliberation on the part of the EU.