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Commission consultation, 9 July 2020
Draft for consultation: COMMISSION REGULATION 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
A copy of the draft Regulation is available on this site (click on image). The draft Annexes are provided in a separate document. See: Draft Hygiene Amendments - Annex.
The consultation period is from 9 July 2020 - 6 August 2020. For more details, see the consultation page at Food safety, allergies & food waste – new EU rules.
Cross-contamination and food allergies have become a matter for increasing concern in the EU and worldwide.
By revising Regulation (EC) No 852/2004 on food hygiene, this initiative aims to:
The following are the initial recitals from the draft Regulation:
(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 ingredients for labelling purposes [see Note 1 below], indicating that the presence of food allergies across Europe has been estimated at around 1% for both adults and children. The Authority concluded that, while food allergies affect a relatively small proportion of the population, an allergic reaction can be severe, even potentially fatal and that it is increasingly apparent that people with food allergies or intolerances experience a very significant reduction in quality of life.
(3) [In October 2020], the Codex Alimentarius 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 requirements introducing good hygiene practices 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 contamination 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 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, ensures the highest value use of edible food resources, while preventing food waste.
(6) On 27 September 2018, the Authority adopted a second scientific opinion on hazard analysis approaches for certain small retail establishments and food donations [see Note 2 below]. 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 guaranteeing its safety for consumers.
(7) [In October 2020], the Codex Alimentarius 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 increasing 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 measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed.
2. EFSA Journal 2018; 16(11):5432