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Annex II, Chapter IX of Regulation (EC) No 852/2004 — Provisions applicable to foodstuffs

Updated 2026-07-12 · Consolidated text as of 2021-03-24 · Reviewed by: Redazione ce85204 — revisione editoriale assistita da AI (2026-07-12)

Annex II, Ch. IX of Regulation (EC) No 852/2004 sets the rules on foodstuffs: rejection of contaminated raw materials, protection from contamination at all stages, an unbroken cold chain (para. 5), rapid cooling after cooking (para. 6), controlled thawing (para. 7) and separation of allergens (para. 9, since 2021).

CHAPTER IX — Provisions applicable to foodstuffsText consolidated as of 2021-03-24 — source EUR-Lex
1

A food business operator is not to accept raw materials or ingredients, other than live animals, or any other material used in processing products, if they are known to be, or might reasonably be expected to be, contaminated with parasites, pathogenic microorganisms or toxic, decomposed or foreign substances to such an extent that, even after the food business operator had hygienically applied normal sorting and/or preparatory or processing procedures, the final product would be unfit for human consumption.

2

Raw materials and all ingredients stored in a food business are to be kept in appropriate conditions designed to prevent harmful deterioration and protect them from contamination.

3

At all stages of production, processing and distribution, food is to be protected against any contamination likely to render the food unfit for human consumption, injurious to health or contaminated in such a way that it would be unreasonable to expect it to be consumed in that state.

4

Adequate procedures are to be in place to control pests. Adequate procedures are also to be in place to prevent domestic animals from having access to places where food is prepared, handled or stored (or, where the competent authority so permits in special cases, to prevent such access from resulting in contamination).

5

Raw materials, ingredients, intermediate products and finished products likely to support the reproduction of pathogenic micro-organisms or the formation of toxins are not to be kept at temperatures that might result in a risk to health. The cold chain is not to be interrupted. However, limited periods outside temperature control are permitted, to accommodate the practicalities of handling during preparation, transport, storage, display and service of food, provided that it does not result in a risk to health. Food businesses manufacturing, handling and wrapping processed foodstuffs are to have suitable rooms, large enough for the separate storage of raw materials from processed material and sufficient separate refrigerated storage.

6

Where foodstuffs are to be held or served at chilled temperatures they are to be cooled as quickly as possible following the heat-processing stage, or final preparation stage if no heat process is applied, to a temperature which does not result in a risk to health.

7

The thawing of foodstuffs is to be undertaken in such a way as to minimise the risk of growth of pathogenic microorganisms or the formation of toxins in the foods. During thawing, foods are to be subjected to temperatures that would not result in a risk to health. Where run-off liquid from the thawing process may present a risk to health it is to be adequately drained. Following thawing, food is to be handled in such a manner as to minimise the risk of growth of pathogenic microorganisms or the formation of toxins.

8

Hazardous and/or inedible substances, including animal feed, are to be adequately labelled and stored in separate and secure containers.

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.

At a glance

Commentary

Rationale and origin

Chapter IX is the part of Annex II that governs the object of production itself: the foodstuff at every stage of its life cycle. Whereas the preceding chapters concern premises, equipment, transport and staff, Chapter IX sets result-based and process rules on the control of contamination, on temperature and on the management of thawing, hazardous substances and allergens. It directly implements the general requirement of Article 4 Article 4(2) of Regulation (EC) No 852/2004 and supplies the technical content on which the hazard analysis of the HACCP system is built: in practice many of the Chapter's requirements become the critical limits and control measures of the food safety management procedures Article 5(2) of Regulation (EC) No 852/2004. Paragraph 9, on allergens, was inserted by Regulation (EU) 2021/382 Article 1 of Regulation (EU) 2021/382.

Personal scope

The Chapter addresses every food business operating after primary production: producers, processors, warehouses, distributors, catering and retail. Some requirements presuppose specific facilities — paragraph 5 requires suitable rooms and sufficient separate refrigerated storage for businesses manufacturing, handling and wrapping processed foodstuffs Annex II, Chapter IX, point 5 of Regulation (EC) No 852/2004 — while others (protection from contamination, cold chain, thawing) apply to any operator, scaled to the nature and size of the activity.

Material scope

Raw materials (paras. 1 and 2). The prohibition on acceptance targets raw materials, ingredients and processing materials contaminated with parasites, pathogenic or toxic micro-organisms, decomposed or foreign substances "to such an extent" that the final product would be unfit for human consumption even after hygienic sorting and processing Annex II, Chapter IX, point 1 of Regulation (EC) No 852/2004. The threshold is result-driven: not every presence bars acceptance, only presence that normal processing cannot bring within acceptable limits. Live animals are excluded from the provision. Once accepted, stored raw materials must be kept so as to prevent harmful deterioration and contamination Annex II, Chapter IX, point 2 of Regulation (EC) No 852/2004.

Protection from contamination (paras. 3 and 4). At all stages of production, processing and distribution food must be protected from any contamination likely to render it unfit, injurious or otherwise unreasonable to consume Annex II, Chapter IX, point 3 of Regulation (EC) No 852/2004. This is the clause that operationally underpins the prevention of cross-contamination between raw and cooked, between allergens and non-allergens, between dirty and clean zones. Paragraph 4 requires adequate procedures to control pests and to prevent domestic animals from accessing places where food is prepared, unless the competent authority permits it in special cases Annex II, Chapter IX, point 4 of Regulation (EC) No 852/2004.

Temperature and cold chain (paras. 5 and 6). This is the best-known core. Raw materials, ingredients, intermediate and finished products likely to support the reproduction of pathogens or the formation of toxins must not be kept at temperatures that might result in a risk to health; the cold chain must not be interrupted Annex II, Chapter IX, point 5 of Regulation (EC) No 852/2004. The Regulation sets no numeric values here: specific temperatures derive from Regulation (EC) No 853/2004 for products of animal origin, from the manufacturer's instructions and from national law. Limited periods outside temperature control are allowed, for the practicalities of handling during preparation, transport, storage, display and service, provided there is no risk to health Annex II, Chapter IX, point 5 of Regulation (EC) No 852/2004: this is the legal basis, for example, for brief display outside refrigeration or short transport. Paragraph 6 requires food to be held or served chilled to be cooled as quickly as possible after the heat-processing or final preparation stage Annex II, Chapter IX, point 6 of Regulation (EC) No 852/2004: rapid chilling is the typical measure to cross quickly the temperature range favourable to pathogens.

Thawing (para. 7). Thawing must minimise the risk of growth of pathogens or formation of toxins, at temperatures that do not result in a risk to health; hazardous run-off liquid must be adequately drained, and after thawing the food must be handled with the same care Annex II, Chapter IX, point 7 of Regulation (EC) No 852/2004. In practice this means thawing under refrigeration and not refreezing a thawed product without an intermediate treatment.

Hazardous substances and allergens (paras. 8 and 9). Hazardous or inedible substances, including animal feed, must be labelled and kept in separate, secure containers Annex II, Chapter IX, point 8 of Regulation (EC) No 852/2004: the rule physically separates detergents, disinfectants and non-food items from food. Paragraph 9, added in 2021, extends the separation logic to allergens: equipment, conveyances and containers used for the substances or products causing allergies or intolerances listed in Annex II to Regulation (EU) No 1169/2011 must not be used for food not containing them unless cleaned and checked for the absence of visible debris Annex II, Chapter IX, point 9 of Regulation (EC) No 852/2004. It should be read together with the allergen information obligations of the labelling rules Article 9 of Regulation (EU) No 1169/2011.

Coordination with other rules

Chapter IX coordinates with Chapter IV on maintaining temperature during transport Annex II, Chapter IV, point 7 of Regulation (EC) No 852/2004, with Chapter XI on the heat treatment of products in hermetically sealed containers Annex II, Chapter XI, point 1 of Regulation (EC) No 852/2004, with Chapter VIII on handler hygiene as an anti-contamination measure Annex II, Chapter VIII, point 1 of Regulation (EC) No 852/2004 and with Chapter Va on the redistribution of food for donation Annex II, Chapter V bis, point 1 of Regulation (EC) No 852/2004. On technical parameters, compliance with temperatures and contamination control is verified through the microbiological criteria of Regulation (EC) No 2073/2005 Article 3 of Regulation (EC) No 2073/2005, with the sampling and testing obligations set out there Article 4 of Regulation (EC) No 2073/2005. Finally, the Chapter gives content to the general ban on placing food that is injurious to health or unfit for human consumption on the market Article 14 of Regulation (EC) No 178/2002.

Application and interpretive issues

The temperature derogation and "practicalities". The derogation in paragraph 5 is the most misunderstood provision: it allows deviations only for limited periods and only where no risk to health arises Annex II, Chapter IX, point 5 of Regulation (EC) No 852/2004. In our view it does not legitimise prolonged display outside refrigeration as ordinary practice: the duration and conditions of the derogation must be defined and justified in the HACCP-based procedures on the basis of a hazard analysis Article 5(2) of Regulation (EC) No 852/2004.

No numeric values in the Chapter. Chapter IX sets no degrees or times: anyone looking for "the legal temperature" must turn to Regulation (EC) No 853/2004 for products of animal origin, to the manufacturer's instructions or to national rules. Attributing to Chapter IX thresholds it does not contain is an error.

Allergens and visible debris. Paragraph 9 sets a minimum standard — cleaning and a check for the absence of visible debris Annex II, Chapter IX, point 9 of Regulation (EC) No 852/2004 — which does not exhaust allergen risk management: unintended allergen presence may require further measures and adequate consumer information Article 9 of Regulation (EU) No 1169/2011.

Penalties

The Chapter contains no penalties of its own: the matter is national, with effective, proportionate and dissuasive measures Article 17(2) of Regulation (EC) No 178/2002. National regimes sanction breaches of the general Annex II requirements; see the country pages.

Case law

As at the update date of this page, there is no Court of Justice of the European Union ruling dedicated specifically to Chapter IX of Annex II to Regulation (EC) No 852/2004. Systemically relevant is CJEU, Fourth Chamber, 13 November 2014, Case C-443/13, Reindl (ECLI:EU:C:2014:2370), on the obligation of the operator at the distribution stage to comply with the microbiological criteria of Regulation (EC) No 2073/2005 Article 3 of Regulation (EC) No 2073/2005: product compliance, at which Chapter IX aims, is also verified through those criteria.

Implementation in the Member States

The Chapter is directly applicable and requires no transposition. Member States act on penalties and on any national temperature thresholds for products not covered by Regulation (EC) No 853/2004; for temperature-controlled transport the requirements of Chapter IV apply. For the national picture and penalties, see the country pages.

Common errors

Frequently asked questions

What does Chapter IX say about the cold chain?

It requires the cold chain not to be interrupted and products supporting pathogens or toxins not to be kept at risky temperatures Annex II, Chapter IX, point 5 of Regulation (EC) No 852/2004. The Chapter sets no degrees: values come from Regulation (EC) No 853/2004 for products of animal origin, the manufacturer or national rules.

Can food be kept out of refrigeration during service?

Yes, but only for limited periods and for the practicalities of handling during preparation, transport, display and service, provided there is no risk to health Annex II, Chapter IX, point 5 of Regulation (EC) No 852/2004. The duration and conditions must be defined and justified in the HACCP procedures on the basis of the hazard analysis Article 5(2) of Regulation (EC) No 852/2004.

How must thawing be carried out under the Regulation?

So as to minimise the growth of pathogens and the formation of toxins, at temperatures that do not result in a risk to health, draining hazardous run-off liquid and handling the food with the same care after thawing Annex II, Chapter IX, point 7 of Regulation (EC) No 852/2004. In practice food is thawed under refrigeration and not refrozen without an intermediate treatment.

Does Chapter IX require allergens to be separated?

Yes, since 2021. Equipment, conveyances and containers used for the allergens listed in Annex II to Regulation (EU) No 1169/2011 must not be used for food not containing them without cleaning and a check for the absence of visible debris Annex II, Chapter IX, point 9 of Regulation (EC) No 852/2004. The paragraph was inserted by Regulation (EU) 2021/382 Article 1 of Regulation (EU) 2021/382 and should be read with the allergen information duties Article 9 of Regulation (EU) No 1169/2011.

Must a restaurant reject raw materials that look spoiled?

Yes. The business must not accept raw materials or ingredients contaminated to such an extent that the final product would be unfit for human consumption even after normal sorting and processing Annex II, Chapter IX, point 1 of Regulation (EC) No 852/2004. The acceptance check is a typical point in the HACCP procedures.

Where must cleaning chemicals be kept in a kitchen?

Hazardous and inedible substances — including detergents, disinfectants and animal feed — must be labelled and stored in separate, secure containers, kept apart from food Annex II, Chapter IX, point 8 of Regulation (EC) No 852/2004.

Does the Regulation require a blast chiller?

Not by name. It requires food to be held or served chilled to be cooled as quickly as possible after heat processing or final preparation, to a temperature that does not result in a risk to health Annex II, Chapter IX, point 6 of Regulation (EC) No 852/2004. A blast chiller is the most common technical means to meet the obligation, but the rule sets the result, not the tool.

Sources

Drafting and review

ce85204 editorial team. Draft generated with AI from primary sources; AI-assisted editorial review (see methodology).