The implementation in Italy of reg. EU 2017/625 reaches the finish line with Legislative Decree. 27/21, on official controls in the food processing chain.
Legislative Decree 2.2.21 no. 27, ‘Provisions for the adaptation of national legislation to the provisions of Regulation (EU) 2017/625‘, effective from 26.3.21, in brief to follow.
Official public inspection, reg. EU 2017/625
Reg. EU 2017/625, in repeal of the former reg. EC 882/04, updates the general principles to be followed by member states in organizing and carrying out official controls on the agri-food chain (1,2,3). First and foremost, the reform extended the scope to a number of areas now so subject to due coordination by a single authority in each member state:
– Plant health and plant protection products,
– Old and new GMOs(NBTs) intended for food and feed production,
– Animal health and animal welfare,
– organic productions,
– geographical indications (e.g., PDO, PGI, TSG, DOC, DOCG),
– CMO (Common Market Organization),
– SOA (animal by-products),
– Import agreements on animals and products imported from third countries (e.g., Brexit),
– European Commission controls in member states and third countries,
– Accreditation of official laboratories.
EU Regulation 2017/625, the challenges
The push toward harmonization of official controls-extended to plant health and animal welfare, including on products entering the EU-aspires to standardize levels of protection in an internal market where there are still asymmetries between the systems in place at the 27 member states (4,5,6). With major implications for food safety, highlighting the need to strengthen collaboration between competent authorities in different countries.
Public controls need to be more effective and efficient, as well as consistent with the FBO’s risk characterization and level of compliance with the standard. Without neglecting the ecommerce channel, which is still, as noted, poorly manned by supervisory activities (7,8,9). Regulation (EU) no. 2017/625 introduced strengthened measures against fraud, as well as operator rating criteria (10,11). Subsequent reg. EU 2019/624 and 2019/627 then updated official controls on animal products. (12)
Implementation reg. EU 2017/625 in Italy, the delegation to the government
The Italian government has received delegated authority to:
(a) to adapt and reconcile existing national provisions with the provisions of Reg. (EU) 2017/625, with express repeal of incompatible national regulations and reordering of coeval ones,
(b) confirm the Ministry of Health as the single coordinating body of competent authorities (under EU Reg. 2017/625, Art. 4) to organize and carry out official controls and official activities in the said sectors, including consumer information,
(c) identify the Ministry of Health as the liaison body for the exchange of communications between the competent authorities of member states,
(d) without prejudice to the unique coordinating role of the Ministry of Health, identify the MiPAAF as the authority in turn responsible for official controls and other official activities on various aspects beyond food and feed safety risk assessments (13,14,15).
Implementation reg. EU 2017/625, d.lgs. 27/21
Legislative Decree. 27/21 consists of 20 articles. Among the purposes is set forth the need to adapt and reconcile the existing national provisions with the provisions of Reg. EU 2017/625 (Legislative Decree 27/21, Article 1).
The competent authorities and control bodies shall be defined in compliance with the delegation, reserving for official control personnel the qualifications of public officials and agents, judicial police officers within the limits of the service to which the officials are assigned, according to the powers conferred on them (Article 2).
Timely reporting requirements to the ASL.
Public personnel and police attached to other institutions who, in the course of carrying out checks conducted for their institutional activities, suspect the presence of non-compliance have a duty to promptly report to the relevant health authorities.
The judicial authority in turn-if it detects possible risks to public health, as part of investigations in areas subject to this decree-must promptly notify the relevant health authorities in order to contain food safety risks. (15)
Ministry of Health, roles and responsibilities
The Ministry of Health has the following roles and responsibilities:
(a) Ensure coordination, uniformity, effectiveness and efficiency of official controls and other official activities conducted by all competent authorities in the national territory, through the adoption of nationwide programmatic plans (e.g., national animal feed plan, NAPA, national animal welfare plan, PNBA),
(b) coordinating cooperation and contacts with the European Commission and other member states in relation to official controls,
(c) Facilitate the exchange of communications between competent authorities in relation to official controls and other official activities,
(d) central authority responsible for the organization and coordination of official controls and other official activities for the prevention and control of transmissible animal diseases, with reference to the areas of animal health and animal welfare.
The health administration may make use of the Carabinieri Health Protection Command as the competent authority, ensuring coordination of its assessment activities with the control activities carried out by other authorities.
Military veterinarians
Military vets – in the hierarchies of the Ministry of Defense, but rather subject to the operational coordination of Health-they are recognized as the competent authority for official inspections and other official control activities to be conducted in military facilities, including those related to the activities of the contingents of the armed forces deployed in international missions. Also through inspections at establishments located outside military facilities that supply goods for the armed forces. The results of these checks must be reported to the local health authority.
MiPAAF, competencies and overlaps
MiPAAF is designated by Legislative Decree. 27/21 as the Competent Authority in the areas of:
– food (standards to ensure fair trade practices and protect consumer interests and information, including labeling standards),
– feed (standards aimed at protecting quality and commodity aspects, including labeling, for profiles that have no impact on safety but may affect the fairness and transparency of commercial transactions),
– Protective measures against plant pests, organic production and labeling of organic products,
– Use and labeling of protected designations of origin, protected geographical indications and traditional specialties guaranteed (Legislative Decree 27/21, Article 2).
The Ministry of Agriculture, Food and Forestry is also listed as the liaison body for the exchange of communications between the competent authorities of member states in the areas just enunciated. In obvious overlap with the Ministry of Health, as well as contrary to reg. EU 2027/625, Article 4.
Multi-year National Control Plan (NCP)
The Multi-Year National Control Plan (NCP), developed by each Member State with the aim of describing the system of official controls throughout the food chain, thus verifying the proper implementation of EU legislation.
In this context, the Ministry of Health, as a single coordinating body, identifies shared methods and tools and coordinates the competent authorities (Regions and Autonomous Provinces, ASLs) responsible for official controls, which must transmit the results each year, to the Ministry of Health, no later than April 30.
Control frequency and risk categories
Official controls must be carried out regularly on all establishments and activities in the various sectors, according to the assigned risk category and with appropriate frequency, taking into account:
(a) Identified hazards associated with animals/goods, activities carried out by FBOs, use of products, processes, materials or substances that may affect the safety, integrity and wholesomeness of food and feed,
(b) ‘historical’ noncompliance of operators,
(c) reliability and results of self-control put in place by FBOs, including private quality certification schemes (Article 4).
It is necessary to carry out official controls without prior notice, except where prior notice is necessary and duly justified for carrying out the controls. On the basis of documented procedures, updated as necessary, containing instructions for relevant personnel to ensure uniformity and effectiveness.
Official controls, procedures
The procedures to be followed in carrying out official controls postulate:
1) Implementation of procedures for verifying the consistency and effectiveness of official controls and other official activities,
2) Taking corrective actions (in self-control, ed.) in case of inadequacies,
3) written documentation (minutes) of the checks carried out, albeit in electronic format, available to the operator,
4) Ensuring a high level of transparency of official controls, with publication (including on the Internet, at least once a year) of data on controls performed,
5) Ensuring the safety and compliance with current regulations of food sold remotely through electronic channels(ecommerce),
6) Taking restrictive measures, such as suspending or closing all or part of non-compliant activities.
Administrative seizures-under Law 689/81, Article 13-may be taken in cases of noncompliance that may pose a risk to human or animal health. (17)
Duties of operators
Operators shall ensure that the competent authorities have access to equipment, means of transport, premises and other places under their control and their adjacencies. As well as to their computer systems, animals and goods under their control, documents including computerized documents of the enterprise and all other information relevant to the safety of the agribusiness supply chain (Legislative Decree 27/21, Article 6). (18) With an obligation to notify the Competent Authority of any changes in data on registered or approved establishments by their respective owners.
During official inspections, operators must provide assistance and cooperation to the staff of the competent authorities. Including by providing, free of charge, a suitable quantity of matrices to enable the formation of samples for analysis. It is further the operators’ obligation to ensure that production/marketing personnel have received appropriate training for their tasks.
Sampling
During the sampling activity, the competent authority must ensure that a sufficient quantity is reserved for the counter-expertise activity placed on the operator’s guarantee, subject to the operator’s explicit waiver (to be recorded in the sampling report) or the possibilities, under special conditions, to proceed with the sampling of a single aliquot. The results of the analysis must be promptly reported to the competent authority, then to the operator.
The operator has the option of activating the dispute procedure by requesting the competent authority to be able to entrust, at its own expense, the review of the documentation of the initial analysis, test or diagnosis. The counter-expertise activity is entrusted to the Istituto Superiore di Sanità (ISS).
Official laboratories
The following are identified official laboratories–Istituto Superiore di Sanità, Istituti Zooprofilattici Sperimentali (IZS), public health laboratories of local health units–that operate in a network, with tasks of analytical activity and advice on human health risks related to chemical, physical and biological hazard factors in living and working environments.
Official laboratories may also conduct analysis, testing and diagnosis for private operators, with care taken to ensure impartiality and no conflict of interest with their institutional roles. To this end, they must ensure the separation of human, structural and financial resources dedicated to their respective areas. (19) National Reference Centers (NRCs) located at IZSs are recognized as an indispensable operational tool of high and proven competence, in the fields of animal health, food hygiene and animal husbandry.
Traceability of veterinary drugs, dedicated feeds and intermediate products
The computerized traceability system for veterinary drugs, medicated feeds and ‘intermediate products’ is to be completed by 28.1.22. From that date, treatment records must be made only in electronic format. (20) Legislative Decree. 27/21, amends and partially repeals Leg. 16.3.06, n. 158.
Obligations on operators and records to be borne by the attending veterinarian and breeder are updated . Provisions on slaughtering for private domestic consumption outside registered or approved establishments are also updated.
Annexes, repeals, financial invariance
In Annex to Legislative Decree. 27/21 specific regulations on sampling-for laboratory analysis, testing and diagnosis-of matrices of interest are introduced.
Historical provisions including RD 20.12.28, no. 3298, Act 30.4.62 no. 283 (subject to Articles 7,10,22) Presidential Decree 26.3.80, No.327, Leg. 27.1. 92, n. 110 (frozen), etc.
Finally, the financial invariance clause-according to which no new or increased burdens or less revenue should arise from public finance-will have to come to terms with the objectives and training needs of inspection personnel.
Dario Dongo, Amaranta Traversa, Sarah Lanzilli, Claudio Biglia
Notes
(1) Dario Dongo, Riccardo Di Farno. Official public controls, the new EU Regulation 2017/625 soon to be in the Official Journal. FARE (Food & Agriculture Requirements) 28.3.17, https://www.foodagriculturerequirements.com/archivio-notizie/controlli-pubblici-ufficiali-il-nuovo-regolamento-ue-2017-625-presto-in-gazzetta
(2) Dario Dongo. Controls, the role of the Health Administration. GIFT (Great Italian Food Trade). 10/30/17, https://www.greatitalianfoodtrade.it/etichette/controlli-il-ruolo-dellamministrazione-sanitaria/
(3) Dario Dongo, Giulia Torre. Official public controls, EU Regulation 2017/625 kicks off. GIFT (Great Italian Food Trade). 12/18/19, https://www.greatitalianfoodtrade.it/sicurezza/controlli-pubblici-ufficiali-al-via-il-regolamento-ue-2017-625
(4) Marta Strinati. Official public controls in decline, the BEUC report. GIFT(Great Italian Food Trade). 2.11.19, https://www.greatitalianfoodtrade.it/sicurezza/controlli-pubblici-ufficiali-in-declino-il-rapporto-beuc
(5) Dario Dongo. Listeria, the Spanish outbreak and the faults of Brussels. GIFT (Great Italian Food Trade). 8/24/19, https://www.greatitalianfoodtrade.it/sicurezza/listeria-l-epidemia-spagnola-e-le-colpe-di-bruxelles
(6) Dario Dongo. Traceability and origin of meat, widespread fraud in France. GIFT(Great Italian Food Trade). 14.10.20, https://www.greatitalianfoodtrade.it/sicurezza/tracciabilità-e-origine-delle-carni-frodi-diffuse-in-francia
(7) Dario Dongo, Marta Strinati. Everli, Carrefour, the ecommerce that deceives. Stoned prices and misleading labels. GIFT (Great Italian Food Trade). 11/28/20, https://www.greatitalianfoodtrade.it/consum-attori/everli-carrefour-l-ecommerce-che-inganna-prezzi-sballati-ed-etichette-fuorvianti
(8) Dario Dongo. Ecommerce, pesticide smuggling. GIFT (Great Italian Food Trade). 10/19/18, https://www.greatitalianfoodtrade.it/salute/ecommerce-contrabbando-di-pesticidi
(9) Dario Dongo. Amazon, expired food unfit for human consumption. 10/26/19, https://www.greatitalianfoodtrade.it/sicurezza/amazon-alimenti-scaduti-e-inidonei-al-consumo-umano
(10) Dario Dongo. Official public controls, measures to combat food fraud in the new EU Regulation 2017/625. FARE(Food & Agriculture Requirements). 3/28/17, https://www.foodagriculturerequirements.com/archivio-notizie/controlli-pubblici-ufficiali-le-misure-a-contrasto-delle-frodi-alimentari-previste-nel-nuovo-regolamento-ue-2017-625
(11) Dario Dongo. Official public audits, operator ratings, and transparency. Does it portend a breakthrough? FARE(Food & Agriculture Requirements).
4/28/17, https://www.foodagriculturerequirements.com/archivio-notizie/controlli-pubblici-ufficiali-rating-degli-operatori-e-trasparenza-si-preannuncia-una-svolta#
(12) Dario Dongo, Melissa Bozzolini. Official public controls on animal products, reg. EU 2019/624 and reg. EU 2019/627. FARE(Food & Agriculture Requirements). 10.6.19, https://www.foodagriculturerequirements.com/archivio-notizie/controlli-pubblici-ufficiali-sui-prodotti-di-origine-animale-reg-ue-2019-624-e-reg-ue-2019-627
(13) The delegation of authority to the government to implement reg. EU 2017/625 in Italy is contained in the 2018 European delegation law, no. 117/2019, in Article 12
(14) NB: The Italian state must in any case ensure the effective coordination of all official controls – starting with planning – by the Ministry of Health as the designated authority (EU Reg. 2017/625, Article 4.2)
(15) Dario Dongo. Official controls, decree scheme to be revised. GIFT(Great Italian Food Trade). 9/20/19, https://www.greatitalianfoodtrade.it/sicurezza/controlli-ufficiali-schema-di-decreto-da-rivedere
(16) Legislative Decree. 27/21 assumes a waiver of the duty to promptly report to the ASL in the event of a need to safeguard investigative secrecy. However, the constitutionality of this exemption is questionable in the face of the higher need to safeguard public health
(17) However, administrative seizures must also come to be allowed in numerous other instances that integrate various risks (e.g., plant health, animal welfare, SOA noncompliance, organic products, geographical indications)
(18) Legislative Decree. 27/21 also provides for the possibility of conducting official public inspections on factory ships and refrigerator vessels even in international waters (with expenses borne by OSA)
(19) IZSs, according to the provisions of Leg. 27/21. May enter into conventions or consulting contracts for the provision of services and the provision of services to public and private entities, associations, and organizations on the basis of regional provisions
(20) Records of processing are prescribed by Leg. 158/06 e 193/06. The new decree specifies how and when treatments are to be recorded, which until 28.1.22 can also be done on an endorsed farm paper register (to be kept for at least five years), immediately followed by communication to the competent veterinary service.
The Minister of Health – subject to the agreement of the Conference of State, Regions and Autonomous Provinces – is mandated to define criteria and procedures for recording in electronic format
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.