The European Commission has published a communication 'on the implementation of food safety management systems covering good hygiene practices and procedures based on HACCP principles, including facilitation / flexibility of implementation in certain food businesses' (2022/C 355/01). (1)
The document updates the previous communication (2016/C 278/01), in the light of the reform of the reg. EC 852/04 (Hygiene 1 Regulation) intervened with the reg. EU 2021/382 (2,3,4). With focus on culture of food safety and management of food allergens. Also in the light of the developments recorded in Codex Alimentarius (2020) and ISO 22000: 2018.
1) Food Safety Management Systems, FSMS. Premise
Management systems of food safety (Food Safety Management System, FSMS) represent the evolution of self-monitoring, which includes good hygiene practices (GHG, Good Hygiene Practices) and HACCP (Hazard Analysis on Critical Control Points).
The collectivities (bars, restaurants, fast food, food delivery) and the small-medium enterprises that represent over 90% of food production in the EU still find it difficult to understand the HACCP system. Although it has already been introduced 30 years ago (dir. 93/43/CE). (4)
The comunication under examination therefore dwells once again, as already in 2016, (5) on good hygiene practices. Now integrated into the broader concept of PRPs, Pre-Requisite Programs, as pillars of prevention and preparation of FSMS.
2) EC Guidelines, 2022
The EC Guidelines on food safety management systems, although they have no legal value, they offer some insights on:
- relationships between GHP, prerequisite programs (PRP), operational PRP (OPPRP) and HACCP, in the framework of a FSMS,
- GHP (Annex I),
- procedures based on the HACCP system (Annex II),
- audit of the FSMS (Annex III).
Target of the document is to promote the development of a culture of food safety in line with the evolution of the international reference standard, ISO 22000.
3) Risk analysis
The concepts points of attention and control points are introduced in the FSMS system to bridge the gap between GHPs and CCPs (Critical Control Points), distinguishing between intermediate and significant risks.
Risk analysis – which is based precisely on examining the dangers and the probability of their occurrence, as well as the seriousness of their potential effects on food safety and public health (6) – plays a central role.
Good hygiene practices (GHP), following the risk analysis, may be sufficient or unsuitable. And in this second case it is appropriate to distinguish the intermediate risks from the significant ones, to be addressed respectively with the operational PRPs and with the CCPs.
3.1) ISO 22000, the high road
The approach adopted by the European Commission to bridge the gap between GHP and CCP - and thus, to classify intermediate risks more precisely than significant ones - follows the path of ISO 22000, by identifying the OPPRPs. That is to say, through appropriate control measures to be taken to prevent or reduce a significant risk to food safety to an acceptable level. (7)
Il Codex Alimentarius General principles of Food Hygiene (CXC 1-1969) instead refers to the «GHPs that require higher attention». With a simplified approach, which indicates the need for a «higher attention», expressed in terms of greater frequency of application, surveillance and verification of the effectiveness of good hygiene practices.
3.2) The three phases of prevention
PRPs - Pre-Requisite Programs, which include the GHP and other practices and procedures (e.g. training and traceability) necessary to establish the basic environmental and operating conditions for the implementation of the HACCP system - must be identified and applied in all Food Safety Management Systems (FSMS).
Identification of the dangers for each phase of the process it is the second phase of the risk analysis which develops, in a third phase, with the identification of the different levels of risk. And so:
– for lower risk levels, the application of effective GHPs may be sufficient to ensure food safety,
– intermediate levels of risk can be addressed preventively through 'intermediate' measures, such as OPPRPs, (7)
– high risks must be controlled through specific CCPs (Critical Control Points), to verify the effectiveness of GHP and OPPRP aimed at preventing them (Communication 2022/C 355/01, Appendix 1).
FAO / WHO Risk characterization of microbiological hazards in food (8) is mentioned, in Appendix 2, as a basic example on which to build the risk analysis and determine GHP, OPPRP, CCP.
4) Allergens, prevention and information
The ambiguity of the European Commission on the risks of involuntary contamination of foods with allergens not declared on the label goes beyond all limits. Where, in this document, simple examples of the application of good hygiene practices (GHP) are reported, and the abstract principle is reaffirmed according to which the Precautionary Allergen Labeling (PAL) must be based on the 'risk analysis' (Annex I, Section 3.7).
Allergens (potentially) present in the product due to cross-contamination, according to the Commission, they should not be included in the ingredients list since they were not added intentionally. However, this same European Commission is involved in product recalls 'suspected of' cross contact from allergens with a priori waiver of risk analysis (9,10).
5) Flexibility for small businesses
Flexibility in applying good hygiene practices and procedures based on the HACCP system, it must always consider the nature of the activity (and the related risks), as well as the size of the establishment. As already foreseen by the reg. EC 852/04 (Hygiene 1 Regulation).
Food safety remains the primary objective to be pursued, where possible, by applying GHGs and reducing the number of CCPs. With a simplification that in fact corresponds to the approach of Codex Alimentarius (See supra, par. 3.1). In short, nothing new.
6) Audit on GHP and HACCP
Official controls must include two types of audit, to verify the suitability of good hygiene practice (GHG) manuals and procedures based on the HACCP system:
- audit complete, with in-depth analysis of all the operational and documentary aspects of the food business operator (FBO) audited,
- audit partial. It often follows a audit complete, which follow-up for verifying compliance with pre-imposed requirements. Or, in general terms, to investigate certain aspects (e.g. traceability, sanitization, training, ..).
6.1) Methods of execution of the audit
The function of audit is 'provide useful information – both to the food business operator and the competent authority – for the purpose of improving compliance'.
Guidelines on how to run the audit are provided in Annex III to the communication in question, with some suggestions on how to identify the shortcomings of the legal obligations and the technical non-conformities.
inspection activities can (and do not 'should') be notified in advance to the operator, when this is 'necessary to ensure the proper conduct of the inspection'. In Appendix 6 an example of official communication is shown.
7) Culture of food safety, evaluation
'To avoid a subjective perception, verification of food safety culture should be done by verifying objective data, eg:
- food hygiene practices,
- staff training,
- the control of the documentation relating to the flow of information and exchanges between employees and managers, o
- performance monitoring such as the results of internal audits'.
A checklist on the culture of food safety, as an example of indicators that the competent authorities can follow in official controls, is available in Appendix 3 to the communication in question.
Staff training of food businesses to food hygiene – for the correct application of GHP and other PRPs, in addition to HACCP procedures – is a key element for fulfilling the requirement of a food safety culture, introduced by reg. EU 2021/382 in reform of the Hygiene 1 Regulation (EC regulation 852/04).
'The formation is often the most important tool for achieving a good food safety culture or for taking corrective action if deficiencies are found when assessing the scope of the food safety culture'(11,12).
7.2) Training by the authorities
The effectiveness of self-control he risk analysis – on which modern food law is based – is closely linked to the level of culture of food safety food business operators (FBOs) and their staff. The importance of specific HACCP training for workers supervising or managing critical control points (CCPs) is therefore underlined.
On the other hand, ‘GHP, other PRP and HACCP training for food business personnel should be commensurate with the nature and size of the business and take into account the specific risks associated with the nature of the business'.
The competent authorities they should therefore consider the opportunity to involve food chain operators in food safety training activities. To this end, the European Commission refers to the FAO/WHO guidance to governments on the application of HACCP in small and/or less-developed food businesses. (13)
8) Final considerations
Food safety it is the prerequisite for any activity that may in any way affect the production, distribution and administration of food and feed, as well as their ingredients and substances introduced into processes and materials and objects in contact with food (MOCA or FCM, Food Contact Materials).
The extreme variability environmental and operational conditions and the emerging risks also highlight how food safety itself is a dynamic concept, a value and an objective to which everyone must contribute with their own skills and experience. To constantly update the practical applications of prevention and control.
Outreach Paths participatory - such as those implemented in the past in the EU program 'Better training for safe food', to which the writer (Dongo) had the opportunity to contribute – should be included in public research and innovation programs, as well as for the promotion of food safety in the various territories.
Dario Dongo and Giulia Pietrollini
Footnotes to the story
(1) European Commission. Commission Notice on the implementation of food safety management systems covering Good Hygiene Practices and procedures based on the HACCP principles, including the facilitation/flexibility of the implementation in certain food businesses https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52022XC0916%2801%29 (2022/C 355/01)
(2) Dario Dongo. EU Reg. 2021/382. Allergen management, safety culture, food redistribution. GIFT (Great Italian Food Trade). 9.3.21
(3) Reg. (EC) No 852/2004, on the hygiene of foodstuffs. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32004R0852&qid=1671973897521 Consolidated text as of 24.3.21 on Eur-Lex
(4) Food and Veterinary Office (FVO), European Commission (2016). Overview Report on the State of Implementation of HACCP in the EU and Areas for Improvement
(5) Dario Dongo. Hygiene in restaurants, the ABC. GIFT (Great Italian Food Trade). 27.12.17
(6) Dario Dongo, Giulia Torre. Official public controls, EU regulation 2017/625 is underway. GIFT (Great Italian Food Trade). 18.12.19
(7) Some examples of OPRPs:
– stricter controls upon receipt of raw materials if the supplier does not guarantee the desired level of safety (e.g. mycotoxins in spices),
– efficient sanitization to control cross-contamination between production batches that contain different allergens (e.g. nuts, soy, milk, ..)
(8) FAO / WHO (2009). Risk characterization of microbiological hazards in food https://www.fao.org/documents/card/en/c/37c8cde5-6b83-5705-ac0e-17f4fdf1209b/ ISBN 978-92-4-154789-5 (WHO)
(9) Dario Dongo. Allergens and RASFF, European blackout. GIFT (Great Italian Food Trade). 13.7.22
- (10) The two-headed DG SANTR (European Commission) also refers to some documents where it expressly refers to Reference Doses (RD) for risk analysis of allergen contamination, including:
Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens – Part 3: Review and establish precautionary labeling in foods of the priority allergens https://www.who.int/news-room/events/detail/2021/10/18/default-calendar/ad-hoc-joint-fao-who-expert-consultation-on-risk-assessment-of-food-allergens-part-3-review-and-establish-precautionary-labelling-in-foods-of-the-priority-allergens
- FoodDrinkEurope. Precautionary Allergen Labeling (PAL): a science-based approach based on Quantitative Risk Assessment https://www.fooddrinkeurope.eu/wp-content/uploads/2021/05/Precautionary-Allergen-Labelling.pdf
(11) Communication 2022/C 355/01, Annex I, Section 4.14
(12) NB: the training of community personnel (e.g. bars, restaurants, fast food) on risk management in case of allergic reactions of patrons should include instructions on the actions to be taken for the emergency room, in the face of the concrete risk of anaphylactic shock with possible lethal outcome and the widespread ignorance found in a recent scientific study by the University of Cologne (Loerbroks et al., 2019). See Dario Dongo. Allergies in the restaurant, guaranteed danger. I study German. GIFT (Great Italian Food Trade). 26.5.19
(13) World Health Organization & Food and Agriculture Organization of the United Nations. (2006). FAO/WHO guidance to governments on the application of HACCP in small and less-developed food businesses. World Health Organisation. https://apps.who.int/iris/handle/10665/43598