The guarantee of the food safety falls into the primary responsibility of food business operators (OSA). (1) Duties, verifications and sanctions, theABC following. In the perspective, among other things, of the reform on official public controls.
Food safety and operator responsibility, basic criteria
The Food Sector Operator (FBO) he must guarantee the compliance of food and feed with safety requirements, also verifying that the companies he controls comply with the legal provisions relating to their activities in all stages of preparation, processing and distribution. (2)
THElabeling it can affect the safety of food, in relation to all mandatory information of health significance. Starting with specific information on the presence of allergens, which must therefore follow specific criteria. As well as in relation to Expiration date, conditions of storage and use, sensitive ingredients (eg caffeine and quinine, glycyrrhizinic acid, sources of phenylalanine, polyols added in quantities greater than 10%, phytosterols and stanols of plant origin).
La traceability of food, feed and MOCA (materials and objects intended to come into contact with food) is prescribed to all operators of the respective supply chains, according to a 'chain' mechanism (one step back, one step beyond). That is to say, each operator must be able to declare, to the authorities upon request, from whom he received which materials and to whom he delivered which goods. Having suitable registers for this purpose, obviously commensurate with the size of the activity and the complexity of the processes. (4)
La internal traceability, although useful for optimizing processes and reducing the costs of any corrective actions, it is not, conversely, prescribed for the generality of products, (5) but only in the meat supply chains. With detailed rules in the bovine livestock sector (reg. CE 1760, 1825/00), more nuanced in the swine, poultry, egg-goat ones.
The management of food security crises is also entrusted, (yes, you can learn it), the responsibility of the operator. Which - in cases of news or even just well-founded fear of non-compliance with safety requirements of a food imported by him, produced, transformed, processed or distributed, which is no longer under his immediate control - must promptly activate the prescribed corrective actions (commercial withdrawal, notification to the competent health authority, information to consumers, any public recall).
The distributor in turn - even when do not participate in any food handling activities (e.g. unpacking, portioning, pre-wrapped), thus limiting its work to logistics and trade - must proceed with the withdrawal of products at risk of security, collaborating with the authorities and other operators involved in the management of the crisis. (6)
The administrative sanctions to be applied the violations of the aforementioned rules - unless the fact constitutes a crime - are those indicated in legislative decree 190/06. The lack of organization of a suitable traceability system is punished with an administrative sanction from € 750 to € 4.500. The omission of necessary corrective actions in situations of food and feed safety crisis is instead subject to penalties ranging from € 3.000 to € 18.000.
The principle of precaution, introduced by General Food Law as a criterion to be followed in the risk analysis, (7) must be interpreted according to the Court of Cassation in the sense that 'the producer, in order to guarantee the safety of the food, has an obligation, as a professional operator, to comply with the precautionary principle and adopt proportionate measures according to the characteristics of the product and its intended use for human consumption '. (8)
Consequently, the OSA he cannot limit himself to relying on the declarations and / or certifications offered by his suppliers to evaluate the safety of the products, which he himself must guarantee under his own responsibility. Exercising self-control - GMP and HACCP - with a level of diligence, prudence and expertise based on the best science and experience applicable in its operating sector at that historical moment.
On the other hand, also in terms of information to the consumer - without prejudice to the primary responsibility of the owner or manager of the brand under which the product is marketed - EU regulation no. 1169/2011 states the shared responsibility of the distributor that sells products which it can presume non-compliance with current regulations. (9)
Food safety and operator responsibility, the Hygiene package
General and specific rules to oversee food safety are foreseen in the cd. Hygiene package. With specific regard to EC regulations no. 852/04 (so-called Hygiene 1, general principles on food safety) and 853/04 (Hygiene 2, detailed rules on products of animal origin). (10)
The reg. CE 852/04 it is applied to all stages of food production, processing and distribution, according to the ancient adage from farm to fork e from stable to table (from farm to fork, from stable to table). Including primary agricultural production and hunting, (11) with the sole exclusion of activities intended for domestic consumption or the direct supply of small quantities of primary products to the final consumer or to local retailers. (12)
The hygiene requirements relating to primary production and related operations (e.g. transport and storage operations), to control measures for any contamination and to the health and welfare of animals and plants'that have relevance to human health ' are indicated in Annex I, part A.
It is thus disciplined cleaning of plants, equipment and animals, health and training of personnel, the use of additives, veterinary medicines, plant protection products and biocides. In addition to keeping the records where to indicate all the measures taken to control the hazards - in relation to the nature and size of the company - and the making available of all relevant information to the competent authorities and operators receiving the products.
All stages subsequent to primary production are in turn subject to the hygiene requirements set out in AAnnex II, which provides for structures intended for food, premises and equipment, waste, water supply, hygiene and staff training, packaging and packaging.
Self-control, in the stages following primary production, must include the application of both good processing practices (GMP, Good Manufacturing Practices), both of procedures based on the principles of the HACCP system, Hazard Analysis and Critical Control Points. (13) An internationally tested system for over three decades, whose function is precisely to identify, control and mitigate risks on food safety, based on a concrete analysis of each phase of the processes.
The HACCP system - around which the Hygiene Package revolves - focuses on 7 main points:
identification of any danger (CP, Critical Points) which must be prevented, eliminated or reduced to acceptable levels,
- identification of critical control points (CCP, Critical Control Points) in the phases in which the verification is essential to prevent, eliminate or reduce the risk identified to acceptable levels,
- define, at the critical control points, the critical limits for the acceptability of the material, for the purpose of preventing, eliminating or reducing risks,
- draw up and apply effective surveillance procedures at critical control points,
- foresee the corrective actions to be taken in the event that the surveillance reveals the failure to consider a critical point,
- establish the procedures, to be applied regularly, to verify the effective functioning of the above measures,
- prepare documents and records appropriate to the nature and size of the company.
The operators they must keep and show to the (health) authorities who request it the documentation certifying the effective application and updating of procedures suitable for the purposes, as well as consistent with the operational reality.
Flexibility measures in favor of micro-enterprises were highlighted in a specific communication by the European Commission in 2017. With the aim of encouraging the effective application of good hygiene practices, in line with manuals prepared by the trade associations, as a basic unit to guarantee safety.
Exceptional hypotheses of derogation with the requirements set out in the annexes of reg. CE 852/04, provided that the achievement of food hygiene objectives is not compromised, are envisaged in favor ofuninterrupted use of traditional methods'. (14)
I products of animal origin they are then subject to additional requirements, contained in EC regulation no. 853/04, starting from the obligation of recognition (or authorization) of the plants, after inspection by the health authority which is also competent to issue the health stamp and identification mark.
Criminal and administrative sanctions for non-compliance with the above provisions, provided for in legislative decree 193/2007, they reach considerable amounts and do not exclude the competition of offenses provided for by other regulations (criminal code, law 283/62).
Consistent application of adequate self-control plans moreover - in the jurisprudence of legitimacy - it has often been used to exclude the criminal liability of operators for the sale of food harmful to human health has excluded the operator's criminal responsibility, where adequate self-control plans had been prepared and the judicial body had not promptly illustrated the reasons why, despite this, profiles of guilt could be integrated. (15)
Operators responsibility and official public controls, reg. EU 2017/625
The EU regulation 2017/625 - 'on official controls and other official activities carried out to ensure the application of legislation on food and feed, rules on animal health and welfare, plant health and plant protection products (...)'- will mainly apply with effect from 14.12.18. (16) Thus repealing the previous reg. CE 882/04.
The new regulation on official public controls aims to establish a harmonized framework at EU level on the organization of official controls throughout the food chain, rationalizing and simplifying the rules that already existed. By expanding, among other things, the definition of 'official control' and its scope, not more limited to food safety but extended to further areas, such as those relating to product quality.
The field of application in fact, it includes the deliberate release into the environment of GMOs, the protective measures against organisms harmful to plants, the requirements for the marketing and use of plant protection products, organic production and the labeling of the relative products, protected geographical indications (eg PDO and PGI), the attestation of official certificates, official controls on products entering the European Union and fraudulent or deceptive practices in the production and labeling of PDO and PGI wines.
Le responsibility of the operators are better defined as regards the specific cooperation obligations with the competent authorities. Where, in in particular, the FBO is required - at the request of the authorities - to provide data relating to the company, list the specific activities carried out and the premises under its control, grant access to all equipment, means of transport, spaces, systems data processing of news on animals, goods, documents and other information, as well as cooperating with operators and providing them with assistance (EU reg. 2017/625, article 15).
In case of non-compliance with current legislation in all the areas listed above, (17) the competent authority will have to ensure that the operator remedies the situations and will take all necessary measures in order to determine the origin and extent of the non-compliance and establish the responsibility of the operators involved, who will have to remedy it and prevent it the repetition.
The competent authorities they will then send the relevant FBO or its representative written notification of the decision on the measures to be taken and information on the right to appeal against such decisions. All costs incurred in relation to the actions taken following verification of a non-compliance are expressly charged to the operators responsible.
La definition of danger - and, consequently, that of risk, is also considerably expanded with respect to the provisions of EC regulation no. 178/2002. Going to include every agent or condition of a food or feed capable of causing a harmful effect not only on human health, but also on animal or plant health, animal welfare or the environment.
Compliance with the rules on animal welfare and plant health therefore notes for the purposes of food safety, but also with specific attention to ensuring that:
- in animal husbandry, the treatments are humane and do not cause unnecessary pain and suffering to animals,
- in the plant sector, the health of crops, public and private green spaces and forests are protected, while safeguarding biodiversity and the environment. (18)
A paradigm shift which also notes for operators, who hire the responsibility to verify the compliance of the company with current legislation, with a view to protecting not only human health, but also animals, plants and the environment. The FBO thus rises to the role of guarantor, in the context of food production, of the health of the entire biological cycle. (19)
The frequency of physical checks, consequently, it is defined and updated on the basis of arisk proportionality approach', that means based on the level of risk you are identifies in relation to the following factors: animals and goods, all activities under the control of operators, location of activities, use of products, processes or substances that may affect the safety of food or feed, animal health and welfare, plant health, GMOs and plant protection products, possible negative impact on the environment, possible deception of consumers. Also taking into account the precedents of the operators (which must be kept by the competent authorities in special registers). (20)
Responsibility of the operators, final summary
The main obligations of the operators in terms of food safety, they can be summarized as follows.
- Compliance of the product food to safety requirements (EU regulation 2017/625, article 3.1.23)
- Obligations in all phases of the production processes:
reg. CE 178/2002, article 17 (integrated supply chain responsibility)
reg. CE 852/04 (generality of products), reg. CE 853/04 (products of animal origin), reg. EU 2017/625 (human, animal and plant health, animal welfare and environmental protection),
traceability (EC reg. 178/02, art. 18),
precautionary principle (EC reg. 178/02, art. 7),
- Corrective actions in case of food and feed safety crisis:
immediate commercial withdrawal, notification to the health authority, consumer information where the products have already reached the retail trade, public recall when any other measure is not sufficient to guarantee a high level of food safety (EC Reg. 178/02, art. 19-20),
cooperation with official control and the other operators involved (EU regulation 2017/625, article 15, EC regulation 178/02, article 19),
Presentation obligations of the food product (EC reg. 178/02, art. 16, EU reg. 1169/2011).
for further, see our free eBooks'Food safety, mandatory rules and voluntary standards' and '1169 penalties. EU Reg. 1169/11, news on foods, controls and sanctions'.
Dario Dongo and Giulia Torre
Footnotes to the story
See. reg. THERE IS 178/02, article 3.3
V.rregulation EC no. 178/2002,articlei 14, 15 and 17
See. reg. THERE IS 178/02, art. 16, ereg. EU 1169/11 (Food Information Regulation)
See rregulation EC no. 178/2002, article 18. By the definition of traceability see the previous Article 3.15
V. Guidelines for the purposes of traceability of food and feed for public health purposes, aI agree State-Regions and Autonomous Provinces of Trento and Bolzano 28.7.05, http://www.gazzettaufficiale.it/atto/serie_generale/caricaDettaglioAtto/originario;jsessionid=t5hTst00ke3mmmz1KMg5ZA__.ntc-as5-guri2a?atto.dataPubblicazioneGazzetta=2005-12-19&atto.codiceRedazionale=05A11176&elenco30giorni=false
See reg. CE 178/02, art. 19
The precautionary principle is indicated in the EC regulation no. 178/2002 to article 7. The previous article 6 frames this principle in the context of risk management
See the Court of Cassation, Saclà judgment no. 15824/2014
See reg. EU 1169/11, art. 8 (Reliability). With particular regard to its paragraph 3
We remember the reg. CE 854/04 (so-called Hygiene 3, official public controls on products of animal origin) and reg. EC 882/04 (first regulation on official public controls), as part of the so-called Hygiene Package (EC regulation 852/04 and following), both repealed by the subsequent reg. EU 2017/625 of 2017
It is meant by primary production - pursuant to reg. CE 178/02, art. 3.17 - 'all stages of the production, rearing or cultivation of primary products, including harvesting, milking and livestock production prior to slaughter and including hunting and fishing and harvesting of wild products'
See reg. CE 852/04 (so-called Hygiene 1), article 1. 2
See reg. CE 852/04, article 5
The possibility of granting the exemptions in question was provided for by reg. CE 852/04, article 13 (final provisions). The Mi.PAAF maintains a list of 'Traditional Agri-food Products' (PAT), updated March 2018 on https://www.politicheagricole.it/flex/cm/pages/ServeBLOB.php/L/IT/IDPagina/398. However, it should be noted that in relation to almost all the PATs, no exceptions were requested in terms of hygiene and health
See for example Cass. Pen. 9.10.02 n. 33630, 6.2.13 no. 5859, and 4.4.17 n. 37436
Title III of reg. EU 2017/625, relating to reference laboratories, is already applicable from 28.4.18. Some rules concerning the protection against pests for plants (methods of sampling and analysis, testing and diagnosis, designation of official laboratories) will instead be applied from 29.4.22
See reg. EU 2017/625, art. 138
See EU regulation no. 2017/625
See reg. EU 2017/625, recitals 7 and 8
See reg. EU 2017/625, art. 9