Reg. EU 2021/382. Allergen management, safety culture, food redistribution


Reg. EU 2021/382, effective 3/24/21, draws attention toward the management of food allergens. As well as introducing the principle of ‘food safety culture‘ and new requirements to be applied to food redistribution.

The Hygiene Package is being updated in the wake of some of the reforms adopted in September 2020 by the Codex Alimentarius Commission. ABC to follow.

Codex Alimentarius and Hygiene Package, updates

Regulation ‘Hygiene 1’ (reg. EC 852/04) – laying down general principles on food safety – is supplemented by reg. EU 2021/382 with three objectives:

A) allergen management. To call the attention of all operators in the supply chain, from farm to fork, to the need to extend self-control to the risk of food contamination with allergens. Also in light of the code of best practices introduced by Codex Alimentarius,

B) food safety culture. Promote food safety awareness and training of all workers, in organizations downstream of the primary agricultural supply chain,

C) food redistribution. Define appropriate hygiene and traceability requirements, to guard food safety, to be applied to food redistribution. Even when such activities are carried out for charitable purposes.


The prevalence of food allergies in Europe has so far been estimated at 3-4% of the general population, with large margins of approximation related to poor coverage of diagnoses. (3) EFSA(European Food Safety Authority), in its latest opinion on the subject, moreover, highlighted the seriousness of the dangers associated with allergic reports, in some cases lethal. (4)

Food allergy report

Managing the risk of contamination of food with allergenic ingredients is still largely underestimated, as evidenced by often outlawed labels (e.g., ‘may contain traces of nuts‘), faulty sales signs and registers or menus, and often absent information in food delivery.

Allergen Management in Codex Alimentarius

A code of best practices for food allergen management by food business operators was adopted in September 2020 by the Codex Alimentarius Commission. (5) Information to consumers and users about the presence of allergens in food-already the subject of special labeling requirements, (6) in the Codex Alimentarius standard dedicated to it-must meet the following principle:

‘Consumers should have access to adequate and correct information on the allergenic nature of a food. This should ensure that those with allergies can avoid allergenic foods and ingredients.’ (7)

The Codex document under review then considers the risks of allergen contamination throughout the entire food supply chain, from primary agricultural production and logistics, to distribution and/or serving to the final consumer. Recalling precautions to be followed and recorded-as a complement to GHPs(Good Hygienic Practices)-to mitigate the above risks. And the additional self-control requirements, such as HACCP, for operators who are subject to them.

Allergen management in the Hygiene Package, primary production

Hygiene measures established in the EU for primary production operators (agriculture and animal husbandry, hunting and fishing, and plant collection) are supplemented as follows:

‘The equipment, vehicles and/or containers used for the collection, transport or storage of substances or products causing allergies or intolerances listed in Annex II of Regulation (EU) No. 1169/2011 shall not be used for the collection, transport or storage of foodstuffs that do not contain such substances or products unless such equipment, vehicles and/or containers have been cleaned and checked at least for the absence of any visible residues of such substances or products’ (EC Reg. 852/04, Annex I, Part A, Section II, new point 5a).

Allergen management in the Hygiene Package, steps after primary production

Operators in the food chain at the stages following primary production are subject to an additional requirement, similar in tenor to that prescribed in primary agricultural production. In this case it refers to ‘equipment, vehicles and/or containers used for processing, handling, transporting or storing‘ allergens.

Such instruments shall not be used for the processing, handling, transportation or storage of food products that do not contain such substances or products, unless‘ they ‘Have not been cleaned and checked at least for any visible residues of such substances or products‘ (EC Reg. 852/04, Annex II, new point 9).

Allergens, zero tolerance

Regulation (EU) 2021/382 addresses allergen management very superficially and lends itself to dangerous interpretations. Therefore, it is worth keeping the basic requirements in mind:

– cross-contamination with allergens is subject to zero tolerance (with the only exception of sulfites allowed in concentrations <10 mg/l, <10 mg/kg). Visual inspection alone following unidentified ‘cleaning’ of vehicles, containers, mixed-use equipment therefore exposes operators to serious liability, including criminal liability,

– trade associations, on the other hand, at the European and national levels, must adapt their respective good hygiene practice manuals to the practices outlined by Codex Alimentarius. Where, in 20 pages of work, the operations necessary to minimize food safety risks related to allergen contamination are specified,

– food business operators are in any case primarily responsible for food safety. It is therefore recommended that everyone compare their good hygiene practice manuals with the Codex Code of Good Practices (5) and where appropriate update them without delay.


A culture of food safety–to be understood in terms of the commitment of ownership and management to train all employees, workers and contractors–is the basic condition for preventing toxins and food safety crises. The Codex Alimentarius Commission, in September 2020, thus updated the ‘General Principles of Food Hygiene‘ standard. (8)

Thus, the European legislature addresses additional requirements to food business operators (FBOs) in the stages following primary agricultural production. That is, to owners and operators of food processing, distribution and serving activities (9,10,11). Who must also ensure and demonstrate adequate training of internal and external staff, with different declinations depending on the characteristics of the organization. As, moreover, was made clear at the time in Italy in the guidelines for the implementation of the Hygiene Package.

Food safety training

General hygienerequirements applicable to all food business operators other than primary production‘ are supplemented by reg. EU 2021/382 with the new chapter on ‘Food Safety Culture‘.

‘1. Food business operators must establish and maintain an appropriate food safety culture, and provide evidence to prove it, by meeting the following requirements:
(a) Commitment by management, in accordance with Section 2, and all employees to the safe production and distribution of food;
(b) Lead role in safe food production and involvement of all employees in food safety practices;
(c) awareness by all employees of the enterprise of food safety hazards and the importance of food safety and hygiene;
(d) open and clear communication among all employees of the enterprise, within an activity and between consecutive activities, including communication of deviations and expectations;
(e) availability of sufficient resources to ensure the safe and hygienic handling of food’ (reg. EC 852/04, Annex II, new Chapter XI-bis).

Food safety culture, management responsibility

Therefore, the legal representative of the organization is subjected to precise organizational responsibilities that actually integrate principles and criteria already established in food safety management systems (e.g., ISO 22000:2018, GFSI guidance) into the Hygiene Package.

‘2. The commitment on the part of the leadership Must include the following actions:

(a) ensure that roles and responsibilities are clearly communicated within each activity of the food enterprise;

(b) maintain the integrity of the food hygiene system when changes are planned and implemented;

(c) verify that controls are carried out on time and efficiently and that documentation is up to date;

(d) ensure that staff have appropriate training activities and supervision;

(e) ensure compliance with relevant regulatory requirements;

(f) encourage the continuous improvement of the enterprise’s food safety management system, taking into account scientific and technological developments and best practices where appropriate.

3. The implementation of food safety culture must take into account the nature and size of the food business’ (EC Reg. 852/04, Annex II, new Chapter XI-bis).


Reducing foodwaste (food waste) is a priority related to food security needs (global food supply security), in fact included among Sustainable Development Goals (SDGs) in UN Agenda 2030 atGoal 12.3. In turn, the European Commission has included this goal-along with reducing food loss (the losses of raw materials and food upstream of distribution)-in its Farm to Fork Strategy.

The redistribution of surplus and/or unsold food, through food banks and other solidarity circuits (e.g., AlterBanc), makes it possible to maintain the highest use value of food resources suitable for human consumption, as well as fulfilling widespread social needs. Therefore, it is necessary to clarify the sanitation requirements to be applied to such activities as well.

Food redistribution, new requirements

The safety and fitness for human consumption of food for redistribution must be verified first and foremost by the operators who give it away, at the stages following primary agricultural production. Microbiologically rapidly perishable products can be given away by the peremptory deadline of the expiration date mentioned on the label. Other foods may also be transferred at a date after the expiration of the minimum storage period (‘best before…’).

Those who receive the food in turn have the burden of verifying its suitability,
‘taking into account at least the following elements:
– the minimum shelf life or expiration date, ensuring that the remaining shelf life is sufficient to allow safe redistribution and use by the final consumer,

– The integrity of the packaging, if appropriate,

– proper storage and transportation conditions, including applicable temperature requirements, (…), if applicable,

– the organoleptic conditions, -the guarantee of traceability (12) in accordance with Implementing Regulation (EU) No. 931/2011 of the Commission, in the case of products of animal origin’ (Reg. EC 852/04, Annex II, new Chapter V-bis).

Dario Dongo


(1) For further discussion, see Dario Dongo’sebook. Food safety, mandatory rules and voluntary standards. FARE(Food and Agriculture Requirements). Download at

(2) V. Codex Alimentarius. General Principles of Food Hygiene, CXC 1-1969 as amended

(3) Sabrina Bergamini. Food allergies and intolerances, attention to diagnosis. GIFT (Great Italian Food Trade). 6.4.19,

(4) EFSA, NDA Panel(EFSA Panel on Dietetic Products, Nutrition and Allergies). Scientific Opinion on the evaluation of allergenic foods and food ingredients for labelling purposes. EFSA Journal 2014 doi:10.2903/j.efsa.2014.NNNN

(5) Codex Alimentarius. Code of practice on food allergen management for food business operators (CXC 80-2020). http://www.%252FCXC%

(6) Codex Alimentarius. General Standard for the Labelling of Prepackaged Foods (CXS 1-1985 as amended, most recently in 2018), V. http://www. %252FCXS% Section Food labels must always indicate the presence of a number of foods and ingredients that have been identified globally as major causes of hypersensitivity (food allergies and intolerances):

– ‘Cereals containing gluten; i.e., wheat, rye, barley, oats, spelt or their hybridized strains and products
– Crustacea and products of these
– Eggs and egg products
– Fish and fish products
– Peanuts, soybeans and products of these
– Milk and milk products (lactose included)
– Tree nuts and nut products; and
– Sulphite in concentrations of 10 mg/kg or more’

(7) See note 5. Section IX, Product information and consumer awareness

(8) Codex Alimentarius. General Principles of Food Hygiene (CXC 1-1969 as amended), %252FCXC%

(9) Giulia Torre, Dario Dongo. Food safety, ABC operator responsibilities. GIFT(Great Italian Food Trade). 6.4.18, %C3%

(10) Dario Dongo, Pier Luigi Copparoni. Distributor liability, insights. 22.5.18. GIFT(Great Italian Food Trade).à-del-distributore-approfondimenti

(11) Dario Dongo. Hygiene in restaurants, the ABCs. GIFT(Great Italian Food Trade). 12/27/17,

(12) Traceability of food of animal origin involves recording the following information:

– Detailed description of foods,
– volume or quantity,
-Name and address of the food handler who shipped the food,
– Name and address of the consignee (owner), if different from the food business operator who shipped the food,
– Name and address of the food business operator to whom the food was shipped,
– Name and address of the consignee (owner) if different from the food handler to whom the food was shipped
– Lot or batch identification reference, if necessary,
– date of shipment (EU reg. 931/11, article 3)