On 14.12.19, Regulation (EU) No. 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‘. Highlights in the brief notes to follow.
Official Public Audits, One Health
One Health is the strategy – shared by WHO (World Health Organization), FAO (Food and Agriculture Organization) and OIE (World Organization for Animal Health) – to address food security and public health with a multi-sectoral approach. Considering both environmental and zoonotic risks at the human-animal-ecosystem interface.
The new regulation, in line with the One Health strategy, thus extends the scope of official public controls to the entire food and livestock supply chain. And it brings together in a single text the organization of controls hitherto distributed in different areas. (1) In particular:
– from seed to fork, seed genetics and the deliberate release of GMOs into the environment,
– from stable to table, animal welfare in addition to the health of animals intended to contribute to the food chain,
– chemical and biological safety, including in aspects involving protective measures against plant pests and requirements on the marketing and use of plant protection products,
– organic production chains and those certified in quality schemes (PDO and PGI),
– official certificates and official controls on products entering the EU,
– consumer information and within the supply chain, as well as deceptive and fraudulent practices.
Danger and risk
Reg. EU 2017/625 finally clarifies the distinction between danger and risk, which has been the subject of countless misunderstandings over the years, in both the private and public sectors. A crucial distinction for the purposes of risk assessment and/or classification, and thus risk management:
– hazard is ‘any agent or condition having potential harmful effects on human, animal or plant health, animal welfare or the environment.’
– risk, conversely, expresses ‘a function of the probability and severity of a harmful effect on human, animal or plant health, animal welfare or the environment resulting from the presence of a hazard.’ (2)
Plant health, animal welfare and the environment come right into the mix of hazards and risks to be considered, once again in the One Health direction. With major implications on the measures to be taken, for example, even in cases of pesticide abuse (where Agro Pontino, to cite one case, leads the way).
Unannounced inspections and operator ratings
Unannounced checks become the rule, to ensure the effectiveness of the checks (see EU Reg. 2017/625, Recital 33). With the sole exceptions of cases of absolute necessity related to their specific nature (e.g., audits and controls in slaughterhouses, where the presence of official public veterinarians is systematic). However, the frequency of controls should be planned on the basis of a ‘risk-proportionality approach’ that considers a number of aspects related to the criticality of supply chains, products and territories. In addition to operators’ backgrounds, which are relevant to their rating (EU Reg. 2017/625, Art. 9).
The rating of operators based on background checks, already provided for in the former reg. EC 882/04, indeed finds new emphasis in the new regulation. Where it is also contemplated to publish the ‘score’ given to individual operators. Albeit, as noted above, under certain conditions. Provision was also made for the enterprise to request new inspections at close time intervals in cases of negative results.
Fraud, forecasts and prospects
Fraud, in turn, will have to receive more attention from regulators. That right in Regulation (EU) no. 2017/625 are also requested to supervise the proper implementation of the so-called Single CMO (reg. EU 1308/13).
New EU rules to combat fraud-which is sorely needed, as it turns out-were announced by the president of the new European Commission led by Ursula von der Leyen. As part of the Farm to Fork (F2F) strategy, which in turn is framed in the so-called.
European Green Deal.
625, eight implementation measures in EU
Eight delegated and implementing regulations of reg. EU 2017/625 were published in 2019. To introduce specific regulations on the following issues:
– methods of conducting official controls on meat productions, the areas of housing and production of live bivalve molluscs, animal products for human consumption,
– models of official certificates , and forms to be used in the annual reports of member states,
– emergency measures to be taken in case of entry into the Union of certain goods, animals subject to official controls at border checkpoints. (3)
625, implementation in Italy
Law 4.10.19 no. 117 delegated the government to adapt (by 2.11.20) existing national legislation to the provisions contained in Reg. (EU) 2017/625. (4) The revision of Legislative Decrees 193/07 and 194/08 was actually started as early as summer 2019. The proposed texts, however-as noted-do not meet the requirements of 625, the so-called OCR(Official Controls Regulation), in four key respects:
– failure to give the Ministry of Health the role of coordinating all public controls performed and to be performed in Italy under the OCR. Where the European regulation prescribes ‘efficient coordination’-to hinge on a single authority in each member state-as a condition of ensuring the ‘consistency and effectiveness of official controls’ in each member state, (5)
– failure to transpose the new European concepts of hazard and risk (see ‘hazard and risk’ section above),
– lack of appropriate contingency measures with respect to different cases of risk. With special regard to risks on feed (already under EC Reg. 178/02, Article 15), as well as with respect to the broader concepts mentioned above,
– ineffectiveness of sanctions. These, as specified by OCR, must be deterrent to the point of highlighting the ‘economic impropriety’ of the offense.
Controls and penalties in Italy
Pending reform, the measures and penalties essentially provided by:
– Legislative Decrees 190/06 and 193/07 on food hygiene and safety (see. free ebook ‘Food safety, mandatory rules and voluntary standards‘),
– d.lgs. 231/17 and 27/17 on food-related consumer information and nutrition & health claims (see free ebook ‘1169 penis. Reg. EU 1169/11. Food news, inspections and penalties‘),
– d.lgs. 142/09 and 26/2017 on feed hygiene and labeling,
– d.lgs. 29/2017, on materials and articles intended to come into contact with food (MOCA)
– d.lgs. 20/18 on organic, d.lgs. 103/16 on PDOs and PGIs, etc. (6)
Dario Dongo and Giulia Torre
Notes
(1) First, the new regulation repeals the former reg. EC 882/2004 (general principles on official public controls in the agri-food chain) and reg. EC 854/2004 (so-called Hygiene 3, supplementary rules for controls on products of animal origin)
(2) See reg. EU 2017/625, Art. 3, para. 23 and 24
(3) See reg. EU 2019/624, 2019/627, 2019/628, 2019/723, 2019/1793 and 2019/2007. Other delegated and implementing acts are:
– the reg. EU 2019/625, which supplements reg. EU) 2017/625 regarding requirements for the entry into the Union of consignments of certain animals and goods for human consumption,
– the reg. EU 2019/626, concerning lists of third countries or regions thereof from which certain animals and goods intended for human consumption are permitted to enter the EU
(4) See Act Oct. 4, 2019, no. 117 ‘for the transposition of European directives and the implementation of other acts of the European Union – European Delegation Act 2018‘, Article 12
(5) See reg. EU 2017/625, Art. 4.2
(6) See Regulation (EU) no. 2017/625, Art. 138