EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/10430/2020 CIS 
(POOL/G4/2020/10430/10430 -EN 
CIS.docx)  
[…](2020) XXX  draft  
 
COMMISSION REGULATION (EU) …/…  
of XXX  
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 COMMISSION REGULATION (EU) …/…  
of XXX  
amending the Annexes to 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  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 852/2004 of the Eur opean Parliament and of the 
Council of 29 April 20 04 on the hygiene of foodstuffs1, and in particular Article 13(1) (c) and 
(d) thereof,  
Whereas:  
(1) Regulation (EC) No 852/2004 lays down general rules for food business operators on 
the hygiene of foodstuffs  taking into account the principle that it is necessary to ensure 
food safety throughout the food chain, starting with primary production. Food business 
operators therefore, need to comply with the general hygiene provisions laid down in 
Annexes I and II of that Regulation.    
(2) On 30 October  2014, the European Food Safety Authority ( ’the Authority’ ) updated its 
scientific advice on the evaluation of allergenic foods and food ingredient s for 
labelling purposes2, indicating that the presence  of food allergies acr oss Europe has 
been estimated at around 1% for both adults and children. The Authority concluded 
that, w hile food allergies affect a relatively small proportion of the population, an 
allergic reaction can be sever e, even potentially fatal  and that it  is in creasingly 
apparent that people with food allergies  or intolerances  experience a very significant 
reduction in quality of life.  
(3) [In October 2020 ], the Codex A limentarius Commission adopted a code of practice on 
food allergen management for food business operators (RCP…), including 
recommendations on the mitigation of food allergen by a harmonised approach in the 
food chain based on general hygiene requirements.   
(4) Considering the adoption of the global standard  RCP…  and the expectations of 
consumers and trade partners  that food produced in the EU complies at least with such 
global standard , it is necessary  to introduce requirement s introducing good hygiene 
practic es to prevent or limit the presence of substances causing allergies or 
intolerances, referred to in Annex II to Regulation (EU) No 1169/2011  in equipment, 
conveyances and/or containers used for the harvesting, transport or storage  of 
foodstuffs . Since cont amination of foodstuffs might take place both at the level of 
primary production and at stages beyond that production, both Annexes I and II to 
Regulation (EC) No 852/2004 should be amended.  
(5) The Farm to Fork Strategy for a fair, healthy and environmental friendly food system , 
adopted by the Commission,  is a key component of the European Green Deal  
                                                 
1 OJ L 139, 30.4.2004, p. 1  
2 http://www.efsa.europa.eu/sites/default/files/consultation/140523.pdf   EN 2  EN initiative . Reducing food waste is one of the objectives of the  Farm to Fork Strategy 
which will also contribute to achieving  a circular  economy . Redistribution of food 
surplus for human consumption, in particular through food donations, where it is safe 
to do so, ensure s the highest value use of edible food resources, while preventing food 
waste.  
(6) On 27 September 2018, the Authority  adopted a second scientific op inion on hazard 
analysis approaches for certain small retail establishments and food donations3. In the 
opinion , it states  that food donations presents several new food safety challenges at 
retail level and therefore  it recommends several additional general hygiene 
requirements. It is therefore necessary to lay down certain requirements  in order  to 
promote and facilitate redistribution of food, while guarant eeing its safety for 
consumers.   
(7) [In October  2020 ], the Codex A limentarius Commission adopted a revision of its 
global standard on  General Principles of Food Hygiene  (CXC 1 -1969). The revised 
CXC 1 -1969  introduces the “ food safety culture ” concept  as a general principle . Food 
Safety Culture  enhances food safety by incr easing the awareness and improving 
behaviour of employees in food establishments . Such impact on food safety  has been 
demonstrated in several scientific publications.  
(8) Considering 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 necessary  to include general requirements on food safety culture in 
Regulation (EC) No 852/2004.  
(9) Regulation (EC) No 852/2004 should be amended accordingly.  
(10) The meas ures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Plants, Animals, Food and Feed,  
HAS ADOPTED THIS REGULATION:  
Article 1  
Annexes I and II to Regulation (EC) No 852/2004 are amended in accordance with the A nnex 
to this Regulation.  
Article 2 
This Regulation shall enter into force on the twentieth  day following 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,  
 For the Commission  
 The President  
 Ursula von der LEYEN  
                                                 
3  EFSA Journal 2018; 16(11):5432  