EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10430/2020 CIS 
(POOL/G4/2020/10430/10430 -EN 
ANNEX CIS.docx)  
[…](2020) XXX  draft  
ANNEX  
 
ANNEX  
to the  
Commission Regulation  
amending Regulation (EC) No 852/2004 of the European Parliament and of the Council 
on the hygiene of foodstuffs as regards food allergen management, redistribution of food 
and food safety culture   EN 1  EN ANNEX  
1) Annex I to Regulation (EC) No 852/2004 is amended as follows:  
In Part A, Section II, the following point 5a is inserted : 
'5a. Equipment, conveyances and/or containers used for the harvesting, transport or storage of 
one of the substances or products causing allergies or intolerances, referred to in Annex II to 
Regulation (EU) No 1169/2011, shall not be used for the harvesting, tr ansport or storage of 
any food not containing that substance or product, unless the equipment, conveyances and/or 
containers have been cleaned and checked at least for the absence of any visible debris 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 following:  
'INTRODUCTION  
Chapters V, Va, VI, VII, VIII, IX, X, XI, XIa and XII apply to all stages of production, 
processing and distribution of food . The remaining Chapters apply as follows:  
– Chapter I applies to all food premises, except premises to which Chapter III 
applies;  
– Chapter II applies to all rooms where food is prepared, treated or processed, 
except dining areas and premises to which Chapter III applies;  
– Chapter III applies to those premises listed in the heading of that Chapter;  
– Chapter IV applies to all transportation;  
(b) The following Chapter Va is inserted after Chapter V:  
' CHAPTER Va  
Redistribution  of food  
Food business operators may redistribute food for the purp ose of food donation subject to the 
following conditions : 
(1) Food business operators shall routinely check if food under their responsibility  is not 
injurious to health and fit for human  consumption in accordance with Article 14(2) of 
Regulation (EC) No 178/2 0021. If not the case,  food business operators  may redistribute 
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 expiry of that date;  
– for food for which a date of minimum durability is applied in accordance 
with Article 2(2)(r) of Regu lation (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 Ann ex X to Regulation (EU) No 
1169/2011, at any time provided .  
                                                 
1 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down 
the general principles and requirements of food law, establishing the European Food Safety Authority 
and laying down procedures in matters of food saf ety (OJ L 31, 1.2.2002, p. 1)  EN 2  EN (2) Food business operators handling food referred to in point  1, shall assess if 
food is not injurious to health and fit for human consumption by taking  into 
account  at least the following : 
– the date of minimum durability or the ‘use by’ date , ensuring  sufficient  
remaining  shelf -life left to allow for the safe redistribution and use by the 
final consumer ; 
– the integrity of the packaging, when applicable;  
– the proper storage and transport condi tions , 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 
Council2, when applicable;  
– the organoleptic conditions ; 
– the assurance of traceability in accordance with Commission 
Implementing Regulation (EU) No 931/20113, in case of products of 
animal origin.  
(c)  In Chapter IX, the following point 9 is inserted : 
‘9 Equipment, conveyances and/or containers used for the processing, handling, transport or 
storage of one of the substances or products causing allergies or intolerances, referred to in 
Annex II to Regulation (EU) No 1169/2011, shall not be used for the processing, handling, 
transport or storage of any food, not containing that substance or product, unless the 
equipment, conveyances and/or containers have been cleaned and checked at least for the 
absence of any visible debris of that substance or product.’  
(d) The following Chapter XIa is inserted after Chapter XI : 
‘CHAPTER XIa  
Food Safety Culture  
1.  Food business operators shall establish, maintain and provide evidence of an 
appropriate food safety  culture by fulfilling  the following requirements:  
(a) commitment of the management, in accordance with point 2, and all employees 
to the safe production and distribution of food;  
(b) leadership toward s the production of safe food and to engage all employees in 
food safety practices;  
(c) awareness of food safety hazards and of the importance of food safety and 
hygiene by all employees in the business;  
(d) open and clear communication between all employees in the business, within 
an activity and between consecutive activit ies, including communication  of 
deviations and expectations;  
                                                 
2 Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down 
specific hygiene rules for food of animal origin (OJ L 139, 30.4.2004, p. 55)  
3 Commission Implementing Regulation (EU) No 931/2011 of 19 September 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)  EN 3  EN (e) availability of sufficient resources to ensure the safe and hygienic handling of 
food.  
2.  Management commitment shall include:  
(a) ensuring that roles and responsibilities are clearly communicated within each 
activity of  the food business;  
(b) maintaining the integrity of the food hygiene system when changes are planned 
and implemented;  
(c)  verifying that controls are being performed timely and efficiently  and 
documentation is up to date;  
(d)  Ensuring  that the appropriate training and supervision are in place for 
personnel;  
(e)  ensuring compliance with relevant regulatory requirements ; 
(f)  encouraging continual improvement  of the food safety management system of 
the business , where appropriate, taking into accoun t 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 .’