COMMI SSION REGUL ATION (EU) 2021/382 
of 3 March 2021 
amending the Annex es to Regulation (EC) No 852/2004 of the European Parliament and of the 
Council on the hygiene of foodst uffs as regards food allergen management, redist ribution of food 
and food safety culture 
(Text with EEA relevance) 
THE EUR OPEAN COMMISSION, 
Havi ng regar d to the Treaty on the Functioning of the European Union, 
Havi ng regard to Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 Apr il 2004 on the 
hygiene of foodstuffs (1), and in particular Article 13(1)(c) and (d) thereof, 
Whereas: 
(1) Regulation (EC) No 852/2004 lays down general rules for food business operat ors on the hygiene of foodstuffs 
taking into account the principle that it is necessar y to ensure food safety throughout the food chain, starting with 
primar y production. Food business operat ors theref ore, need to comply with the general hygiene provi sions laid 
down in Annex es I and II of that Regulation. 
(2) On 30 October 2014, the European Food Safety Auth ority (‘the Author ity’) updated its scientific advice on the 
evaluation of allergen ic foods and food ingredients for labelling purposes (2), indicating that the presence of food 
allergies across Europe has been estimated at 3 % to 4 % for both adults and children. The Author ity concluded that, 
while food allergies affect a relatively small propor tion of the population, an allergic reaction can be severe, even 
poten tially fatal and that it is increasing ly apparent that people with food allergies or intol erances exper ience a very 
signif icant reduction in quality of life. 
(3) In Sept ember 2020, the Codex Alimentar ius Commission adopt ed a code of practice on food allergen manag ement 
for food business operators (CXC 80-2020) including recommendations on the mitigation of food allergen s by a 
harmonised approach in the food chain based on general hygiene requirements. 
(4) Consider ing the adoption of the global standard CXC 80-2020 and the expectations of consumers and trade partners 
that food produced in the EU complies at least with such global standard, it is necessar y to introduce requirements 
introducing good hygiene practices to prevent or limit the presence of substances causing allergies or intolerances, 
refer red to in Annex II to Regulation (EU) No 1169/2011, in equipment, conve yances and/or containers used for 
the harvesting, transpor t or storag e of foodstuffs. Since contamination of foodstuffs might take place both at the 
level of primar y production and at stages beyond that production, both Annex es I and II to Regulation (EC) 
No 852/2004 should be amended. 
(5) The Farm to Fork Strateg y for a fair, healthy and environmental friendly food system, adopt ed by the Commission, is 
a key compo nent of the European Green Deal initiative. Reducing food waste is one of the objectives of the Farm to 
Fork Strategy whic h will also contr ibute to achieving a circular economy . Redistr ibution of food surplus for human 
consum ption, in particular through food donations, where it is safe to do so, ensures the highest value use of edible 
food resources, while preventing food waste . 
(6) On 27 Sept ember 2018, the Author ity adopt ed a second scientific opinion on hazard analysis approaches for certain 
small retail establishments and food donations (3). In the opinion, it states that food donations presents several new 
food safety challenges at retail level and theref ore it recommends several additional general hygiene requirements. It 
is theref ore necessar y to lay down certain requirements in order to promote and facilita te redistr ibution of food, 
while guarant eeing its safety for consumers. 
(1)OJ L 139, 30.4.2004, p. 1. 
(2)http://www .efsa.europa.eu/sites/def ault/files/consultation/140523.pdf 
(3)EFSA Journal 2018; 16(11):5432 EN Offi cial Jour nal of the European Union 4.3.2021                                                                                                                                             L 74/3   (7) In September 2020, the Codex Alimentar ius Commission adop ted a revision of its global standard on Gener al 
Principles of Food Hygiene (CXC 1-1969). The revised CXC 1-1969 introduces the ‘food safety culture’ concep t as a 
general principle. Food safet y culture enhances food safety by increasing the awar eness and impro ving behaviour of 
emplo yees in food establishments. Such impact on food safety has been demonstrated in several scientific 
publications. 
(8) Consider ing the revision of the global standard and the expectations of consumers and trade partners that food 
produced in the EU complies at least with such global standard, it is necessar y to include general requirements on 
food safety culture in Regulation (EC) No 852/2004. 
(9) Regulation (EC) No 852/2004 should be amended according ly. 
(10) The measures provid ed for in this Regulation are in accordance with the opinion of the Standing Committ ee on 
Plants, Animals, Food and Feed, 
HAS ADOPTED THIS REGUL ATION: 
Article 1 
Annex es I and II to Regulation (EC) No 852/2004 are amended in accordance with the Annex to this Regulation. 
Article 2 
This Regulation shall enter into force on the twentieth day followi ng that of its publication in the Official Journal of the 
European Union. 
This Regulation shall be binding in its entirety and directly applicable in all Member States. 
Done at Brussels, 3 March 2021.  
For the Commission 
The President 
Ursula VON DER LEYEN     EN Offi cial Jour nal of the European Union L 74/4                                                                                                                                              4.3.2021   ANNEX 
(1) Annex I to Regulation (EC) No 852/2004 is amended as follows : 
In Part A, Section II, the followi ng point 5a is inser ted: 
‘5a. Equipment, conve yances and/or containers used for the harvesting, transpor t or storage of one of the substances 
or products causing allergies or intolerances, refer red to in Annex II to Regulation (EU) No 1169/2011, shall not 
be used for the harvesting, transpor t or storag e of any food not containing that substance or product, unless the 
equipment, conve yances and/or containers have been cleaned and check ed at least for the absence of any visible 
debr is of that substance or product.’ 
(2) Annex II to Regulation (EC) No 852/2004 is amended as follows: 
(a) the introduction is replaced by the followi ng: 
‘INTR ODUCTION 
Chapt ers V, Va, VI, VII, VIII, IX, X, XI, XIa and XII apply to all stages of production, processing and distr ibution of food. 
The remaining Chapt ers apply as follows: 
— Chapt er I applies to all food premises, excep t premises to which Chapt er III applies, 
— Chapt er II applies to all rooms where food is prepared, treated or processed, excep t dining areas and premises to 
which Chapt er III applies, 
— Chapt er III applies to those premises liste d in the heading of that Chapt er, 
— Chapt er IV applies to all transpor tation,’; 
(b) the followi ng Chapt er Va is inser ted after Chapt er V: 
‘CHAPTER Va 
Redist ribution of food 
Food business operators may redistr ibute food for the purpose of food donation subject to the follo wing conditions: 
(1) Food business operat ors shall routinely chec k if food under their responsibility is not injur ious to health and is fit 
for human consum ption in accordance with Article 14(2) of Regulation (EC) No 178/2002 (*). If the chec k carried 
out is satisf actory , food business operat ors may redistr ibut e food in accordance with point (2): 
— for food for which a “use by” date is applied in accordance with Article 24 of Regulation (EU) No 1169/2011, 
before the expir y of that date, 
— for food for which a date of minimum durability is applied in accordance with Article 2(2)(r) of Regulation (EU) 
No 1169/2011, up to and after that date , or 
— for food for which a date of minimum durability is not required in accordance with point 1(d) of Annex X to 
Regulation (EU) No  1169/2011, at any time provid ed. 
(2) Food business operators handling food refer red to in point 1, shall assess if food is not injur ious to health and fit for 
human consum ption by taking into account at least the followi ng: 
— the date of minimum durability or the “use by” date, ensur ing sufficient remaining shelf-life left to allow for the 
safe redistr ibution and use by the final consumer , 
— the integrit y of the pack aging, when applicable, 
— the proper storage and transpor t conditions, including applicable temperature requirements, 
— the date of freezing in accordance with point 2(b) of Section IV of Annex II to Regulation (EC) No 853/2004 of 
the European Parliament and of the Council (**), when applicable, 
— the organoleptic conditions, EN Offi cial Jour nal of the European Union 4.3.2021                                                                                                                                             L 74/5   — the assurance of traceability in accordance with Commission Implementing Regulation (EU) No 931/2011 
(***), in case of products of animal origin. 
_____________ 
(*) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 Januar y 2002 laying down 
the general principles and requirements of food law, establishing the European Food Safet y Author ity and laying 
down procedures in matte rs of food safet y (OJ L 31, 1.2.2002, p. 1). 
(**) Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 Apr il 2004 laying down 
specifi c hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55). 
(***) Commission Implementing Regulation (EU) No 931/2011 of 19 Sept ember 2011 on the traceability 
requirements set by Regulation (EC) No 178/2002 of the European Parliament and of the Council for food of 
animal origin (OJ L 242, 20.9.2011, p. 2).’; 
(c) in Chapt er IX, the follo wing point 9 is inser ted: 
‘9. Equipment, conveyances and/or containers used for the processing, handling, transpor t or storag e of one of the 
substances or products causing allergies or intol erances, referred to in Annex II to Regulation (EU) No 1169/2011, 
shall not be used for the processing, handling, transpor t or storage of any food, not containing that substance or 
product, unless the equipment, conveyances and/or containers have been cleaned and check ed at least for the 
absence of any visible debr is of that substance or product.’; 
(d) the followi ng Chapt er XIa is inser ted after Chapt er XI: 
‘CHAPTER XIa 
Food Safe ty Culture 
1. Food business operators shall establish, maintain and provid e evidence of an appropr iate food safet y culture by 
fulfilling the followi ng requirements: 
(a) commitment of the management, in accordance with point 2, and all emplo yees to the safe production and 
distr ibution of food; 
(b) leadership towards the production of safe food and to engag e all emplo yees in food safet y practices; 
(c) awar eness of food safety hazards and of the impor tance of food safety and hygiene by all emplo yees in the 
business; 
(d) open and clear communication between all emplo yees in the business, 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. 
2. Management commitment shall include: 
(a) ensur ing that roles and responsibilities are clearly communicat ed within each activity of the food business; 
(b) maintaining the integrity of the food hygiene system when chang es are planned and implemented; 
(c) verifying that controls are being performe d timely and efficiently and documentation is up to date; 
(d) ensur ing that the appropr iate training and super vision are in place for personnel; 
(e) ensur ing compl iance with relevant regulator y requirements; 
(f) encouraging continual impro vement of the food safety manag ement system of the business, where appropr iate, 
taking into account developments in science, technology and best practices. 
3. The implementation of the food safety culture shall take account of the nature and size of the food business.’   EN Offi cial Jour nal of the European Union L 74/6                                                                                                                                              4.3.2021