Consumer

Food safety, ABC operator responsibilities

April 6, 2018

The assurance of food safety falls under the primary responsibility of food business operators (FBO). (1) Duties, checks and sanctions, theABC to follow. In the perspective of, among other things, the reform on official public controls.

Food safety and operator liability, basic criteria

The Food Business Operator (FBO)
must ensure the compliance of food and feed with safety requirements, while also verifying that the enterprises under his control comply with the legal provisions inherent in their activities at all stages of preparation, processing and distribution. (2)

All foods placed on the market
– regardless of their origin or provenance, quality and price-must be safe and suitable for human consumption. Having regard to their conditions of use, as well as the information accompanying them.

L’

labeling

can affect food safety, in relation to all mandatory health-relevant information. Beginning with specific information on the presence of allergens, which must therefore follow special criteria. As well as in relation to expiration date
, conditions of storage and use.

, sensitive ingredients (e.g., caffeine and quinine, glycyrrhizinic acid, sources of phenylalanine, polyols added in amounts greater than 10%, phytosterols and stanols of plant origin).

The

traceability
of food, feed and MOCAs(materials and objects intended to come into contact with food) is prescribed to all operators in the respective supply chains, according to a ‘chain’ mechanism (
one step back,

one step beyond
). That is, each operator must be able to declare, to authorities upon request, from whom he received what materials and to whom he delivered what goods. Having suitable records for this purpose, obviously commensurate with the size of the business and the complexity of the processes. (4)

Internal traceability, although useful for optimizing processes and reducing the costs of any corrective actions, is conversely not prescribed for the generality of products, (5) but only in meat supply chains. With detailed rules in the bovine livestock supply chain (EC reg. 1760, 1825/00), more nuanced in the swine, poultry, and egg and goat sectors.

The management of food security crises
is also entrusted,
first and foremost
, to the responsibility of the operator. Which – in cases of news or even well-founded fear of non-compliance with safety requirements of a food imported, produced, processed, manufactured or distributed by him or her that is no longer under his or her immediate control-he or she must promptly activate the prescribed corrective actions (commercial recall, notification of the competent health authority, consumer information, possible public recall).

The distributor in turn
– When even not participating in any food handling activities (e.g. unpacking, portioning, pre-packaging), thus limiting its work to logistics and trade – must proceed to the withdrawal of products with safety risks, cooperating with the authorities and other operators involved in crisis management. (6)

The administrative sanctions to be applied
to violations of the aforementioned regulations-unless the act constitutes a crime-are those specified in Legislative Decree 190/06. Failure to organize a suitable traceability system is punishable by an administrative penalty of €750 to €4,500. On the other hand, the omission of dutiful corrective actions in food is feed safety crisis situations is subject to penalties ranging from €3,000 to €18,000.

The principle of

precaution
, introduced by the
General Food Law
as a criterion to be followed in risk analysis, (7) should be interpreted according to the Supreme Court to mean that ”
the producer, in order to ensure the safety of food, has an obligation, as a professional operator, to
adhere to the precautionary principle and take proportionate measures according to the characteristics of the product and its intended use for human consumption’. (8)

Consequently, the FBO
cannot simply rely on the claims and/or certifications offered by his suppliers to assess the safety of the products, which he himself must guarantee on his own responsibility. Exercising self-control – GMP and HACCP – with a level of diligence, prudence and expertise marked by the best science and experience applicable in its field of operation at that historical moment.

On the other hand., including on the subject of consumer information – without prejudice to the primary responsibility of the owner or manager of the trademark under which the product is marketed – EU Regulation No. 1169/2011 affirms the concurrent responsibility of the distributor Who sells products whose non-compliance with applicable standards can be presumed. (9)

Food safety and operator liability, the

Hygiene Package

General and specific standards to protect food safety
are provided in the so-called

Hygiene Package

. With precise regard to EC Regulations no. 852/04 (so-called Hygiene 1, general principles on food safety) and 853/04 (Hygiene 2, detailed rules on animal products). (10)

Reg. EC 852/04 applies to all stages of food production, processing and distribution, according to the ancient adages
from farm to fork
e
from stable to table
(from farm to fork, from stable to table). Including primary agricultural production and hunting activities, (11) excluding only activities for domestic consumption or direct supply of small quantities of primary products to the final consumer or local retailers. (12)

Hygiene requirements Related to primary production and related operations (e.g., transport and storage operations), to measures to control possible contamination, and to animal and plant health and welfare ‘That have relevance to human health’ are shown in Annex I, Part A.

The following is thus regulated.
the cleaning of facilities, equipment and animals, the health and training of personnel, the use of additives, veterinary medicines, plant protection products and biocides. In addition to record keeping where all measures taken to control hazards-relating to the nature and size of the enterprise-are indicated, and all relevant information is made available to the competent authorities and operators receiving products.

All stages following primary production
are in turn subject to the hygiene requirements set out in AnnexII, which provides for food facilities, premises and equipment, waste, water supply, staff hygiene and training, packaging and wrapping.

Self-control.
, in the stages following primary production, must include the application of both good manufacturing practices (GMP,
Good Manufacturing Practices
) and of procedures based on the principles of the HACCP system ,
Hazard Analysis and Critical Control Points.
(13) An internationally proven system for more than three decades, the function of which is precisely to identify, control mitigate food safety risks, based on concrete analysis of each process step.

The HACCP system
– around which the Hygiene Package revolves – revolves around 7 main points:

identification of each hazard (CP,
Critical Points
) that must be prevented, eliminated or reduced to acceptable levels,
Identification of critical control points (CCPs,
Critical Control Points
) at stages where verification is essential to prevent, eliminate or reduce the identified risk to acceptable levels,
Define, at critical control points, critical limits for material acceptability for the purpose of preventing, eliminating or reducing risks,
Draw up and implement effective surveillance procedures at critical control points,
Provide for corrective actions to be taken if surveillance reveals that a critical point has not been considered,
Establish procedures, to be applied regularly, to verify the effective operation of the above measures,
Prepare documents and records appropriate to the nature and size of the enterprise.

Operators
must keep and show to (health) authorities who request them documentation that they have effectively implemented and updated procedures that are fit for purpose, as well as consistent with operational reality.

Flexibility measures

in favor of micro-enterprises

were highlighted in a special communication from the European Commission in 2017. With the aim of encouraging the effective implementation of good hygiene practices, in line with the

manuals

prepared by professional associations, as a garrison-base to ensure safety.

Exceptional cases of derogation
to the requirements of the annexes of reg. EC 852/04, provided that the achievement of food hygiene objectives is not compromised, are provided in favor of the ‘
uninterrupted use of traditional methods’.
(14)

I

products of animal origin
are then subject to additional requirements, contained in EC Regulation No. 853/04, starting with the requirement that facilities be recognized (or licensed) after inspection by the health authority, which is also responsible for issuing health stamps and identification marks.

The criminal and administrative penalties
for non-compliance with the above provisions, provided for in Legislative Decree 193/2007, reach considerable amounts and do not exclude competing offenses under other legislation (Criminal Code, Law 283/62).

The consistent application of appropriate self-control plans of the rest – in the jurisprudence of legitimacy – has often served to exclude the criminal liability of operators for the sale of food harmful to human health ruled out criminal liability of the operator where adequate self-control plans were in place and the adjudicating body had not pointedly explained the reasons why, despite this, fault profiles were integrable. (15)

Operator liability and official public controls, reg. EU 2017/625

EU Regulation 2017/625
– ‘
on official controls and other official activities carried out to ensure the enforcement of food and feed law, animal health and welfare, plant health and plant protection products (…)
‘ – will be applied, predominantly, effective from 14.12.18. (16) Thus repealing the former reg. EC 882/04.

The new regulation on

official public controls
aims to establish a harmonized EU-wide framework on the organization of official controls throughout the food chain, streamlining and simplifying the rules that already existed. By, among other things, broadening the definition of ‘official control’ and its scope, no longer limited to food safety but extended to additional areas, such as those pertaining to product qualities.

The scope of application goes in fact to include the deliberate release of GMOs into the environment, protective measures against plant pests, requirements on the placing on the market and use of plant protection products, organic production and labeling of related products, protected geographical indications (e.g., PDO and PGI), 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.

The

responsibilities of operators
are better defined with regard to specific obligations to cooperate with competent authorities. Where, in in particular, the FBO is required-at the request of the authorities-to provide data on the enterprise, list the specific activities carried out and the premises under its control, grant access to all equipment, means of transport, space, computer systems for processing animal, goods, documents and other information, and cooperate with and provide assistance to operators (EU Reg. 2017/625, Article 15).

In case of non-compliance with current regulations
In all the areas listed above, (17) the competent authority shall ensure that the operator remedies the situations and shall 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 shall remedy it and prevent its recurrence.

The competent authorities
will therefore send written notification of the decision on the measures to be taken and information regarding the right of appeal against such decisions to the FBO concerned or its representative. All costs incurred in connection with actions taken following verification of a noncompliance are expressly placed on the responsible operators.

The

definition of hazard
– and, consequently, that of hazard, is also expanded considerably from that in EC Regulation No. 178/2002. Going to include any agent or condition of a food or feed that is capable of causing an adverse 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
is therefore relevant to food safety, but also with specific attention to ensuring that:

– in animal husbandry, treatments are humane and do not cause unnecessary pain and suffering to animals,

– in the plant sphere, the health of crops, public and private green spaces and forests are protected, while safeguarding biodiversity and the environment. (18)

A paradigm shift
that also notes for operators, who assume responsibility for verifying the company’s compliance with applicable regulations, with a view to protecting not only human health, but also animals, plants and the environment
.
The FBO thus rises to the position of guarantor, in the context of food production, of the health of the entire biological cycle. (19)

The frequency of physical checks, consequently, is defined and updated on the basis of a ‘proportionality approach to risk‘, i.e. Based on the level of risk that you identifies in relation to the following factors: animals and commodities, all activities under the control of operators, location of activities, use of products, processes or substances that may affect food or feed safety, animal health and welfare, plant health, GMOs and plant protection products, possible negative impact on the environment, possible deception of that consumers. Also taking into account the track record of the operators (which must be kept by the relevant authorities in special records). (20)

Operators’ responsibilities, concluding summary

The main obligations of operators
in food safety can be summarized as follows.

Compliance

of the product
food to safety requirements (EU reg. 2017/625, Article 3.1.23)
Obligations at all stages of production processes.
:

reg. EC 178/2002, Article 17 (integrated supply chain responsibility)
reg. EC 852/04 (generality of products), reg. EC 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 the event of a

food and feed safety crises:

immediate commercial withdrawal, notification to the health authority, consumer information where products have already reached the retail trade, public recall when any other measure is not sufficient to ensure a high level of food safety (EC Reg. 178/02, Art. 19-20),
cooperation with official control and other operators involved (EU reg. 2017/625, Art. 15, EC reg. 178/02, Art. 19),

Presentation requirements
of the food product (EC Reg. 178/02, Art. 16, EU Reg. 1169/2011).

For further study.
, see our free eBooks ‘

Food safety, mandatory rules and voluntary standards

‘ e ‘1169 penis. Reg. EU 1169/11, food news, controls and penalties‘.

Dario Dongo and Giulia Torre

Notes

Cf. reg. CE 178/02, Article 3.3
V. regulation EC no. 178/2002, articlei 14, 15 e 17
Cf. reg. CE 178/02, art. 16, and reg. EU 1169/11 (
Food Information Regulation
)
See the regulation EC no. 178/2002, Article 18. For the definition of
traceability
see the previous Article 3.15
V. Guidelines for the purpose of food and feed traceability for public health purposes, accord State-Regions and Autonomous Provinces of Trent 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
V. reg. EC 178/02, art. 19
The precautionary principle is stated in EC Regulation No. 178/2002 in Article 7. Article 6 above frames this principle within the framework of risk management
Cf. Court of Cassation, Saclà Judgment No. 15824/2014
V. reg. EU 1169/11, art. 8 (Responsibility). With particular regard to its paragraph 3
Regs. EC 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), under the so-called Hygiene Package (reg. EC 852/04 et seq.), both of which were repealed by the subsequent reg. EU 2017/625 of 2017
Primary production is defined as – within the meaning of reg. EC 178/02, Art. 3.17 – ‘all stages of production, breeding or cultivation of primary products, including harvesting, milking and livestock production prior to slaughter and including hunting and fishing and gathering of wild products’
See EC Reg. 852/04 (so-called Hygiene 1), Article 1. 2
Cf. reg. EC 852/04, Article 5
The possibility of granting the exemptions in question was provided for in reg. EC 852/04, Article 13 (final provisions). Mi.P.A.A.F. maintains a list of ‘Traditional Agri-food Products’ (PAT)

, updated March 2018 at

https://www.politicheagricole.it/flex/cm/pages/ServeBLOB.php/L/IT/IDPagina/398

. It should be noted well, however, that in relation to almost all of the PATs, no sanitation exemptions have been requested
See, for example, Cass. Pen. 9.10.02 n. 33630, 6.2.13 n. 5859, and 4.4.17 no. 37436
Title III of reg. EU 2017/625 on reference laboratories is applicable as early as 28.4.18. In contrast, some regulations pertaining to protection against plant pests (methods of sampling and analysis, testing and diagnosis, designation of official laboratories) will be implemented as of 29.4.22
Cf. reg. EU 2017/625, Art. 138
See EU Regulation no. 2017/625
V. reg. EU 2017/625, recitals 7 and 8
Cf. reg. EU 2017/625, Art. 9