Annex II, Chapter X of Regulation (EC) No 852/2004 — Provisions applicable to the wrapping and packaging of foodstuffs

Rationale and origin

Chapter X closes the hygiene cycle of the product: after preparation, handling and any heat treatment, the food is enclosed in a container that travels with it to the consumer. The logic mirrors the whole of Annex II — prevent contamination at every stage Article 4(2) of Regulation (EC) No 852/2004. The legislator distinguishes, without expressly defining them, wrapping (the primary material in direct contact with the food, such as film, a tray or a vacuum bag) from packaging (the secondary container gathering one or more wrapped units, such as a carton). Both are subject to the same underlying prohibition: not to be a source of contamination Annex II, Chapter X, point 1 of Regulation (EC) No 852/2004.

Who is bound

The chapter applies to any food business operator carrying out wrapping or packaging operations, whatever the size of the business: canneries, dairies, delicatessen workshops, restaurants packing takeaway or vacuum-packed meals, bars and cafés wrapping products, food trucks. Proportionality bears on how controls are organised, not on whether the requirement applies.

What it covers

The four points span the whole life of the material. Point 1 states the principle: no migration or transfer that contaminates the food Annex II, Chapter X, point 1 of Regulation (EC) No 852/2004. Point 2 governs storage: virgin materials must be kept away from dust, moisture, pests and any contamination risk, consistently with the requirements on foodstuffs and on equipment Annex II, Chapter X, point 2 of Regulation (EC) No 852/2004. Point 3 governs the operation: it must avoid contamination, with a reinforced duty "where appropriate" for cans and glass jars, whose integrity and cleanliness must be assured — a technical reference to the risk of glass or metal foreign bodies and of seaming defects in canned goods Annex II, Chapter X, point 3 of Regulation (EC) No 852/2004. Point 4 covers re-use: re-used wrapping and packaging must be easy to clean and, where necessary, to disinfect Annex II, Chapter X, point 4 of Regulation (EC) No 852/2004, a requirement that in practice concerns crates and returnable containers.

Interaction with other rules

The most misunderstood point. Chapter X of Regulation 852/2004 governs the hygiene of the wrapping operation; it does not lay down which materials are suitable for food contact. That suitability is the subject of a distinct, specialised body of law, the food contact materials (FCM) framework: Regulation (EC) No 1935/2004 requires materials to be sufficiently inert not to transfer their constituents to food in quantities that could endanger human health or bring about an unacceptable change in the food's composition Article 3 of Regulation (EC) No 1935/2004, with a declaration of compliance and documentary traceability Article 16 of Regulation (EC) No 1935/2004. Good manufacturing practice for FCM is in turn governed by Regulation (EC) No 2023/2006 Article 4 of Regulation (EC) No 2023/2006. In short: what I may place in contact with food is FCM law; how I must wrap it hygienically is Chapter X.

Within the hygiene regulation, Chapter X connects with Article 5: the choice of material and the wrapping steps must be considered in the hazard analysis where they are relevant to safety (for example modified atmosphere, vacuum, hermetic sealing) Article 5(1) of Regulation (EC) No 852/2004. Where the product is placed in hermetically sealed containers and heat-treated, Chapter XI applies in addition Annex II, Chapter XI, point 1 of Regulation (EC) No 852/2004.

Practical application and interpretive knots

In our view the recurring error is to reduce Chapter X to merely choosing a "food-grade" pack: the glass-and-fork symbol attests the FCM compliance of the material, not the hygiene of the operation. Correct storage of virgin materials Annex II, Chapter X, point 2 of Regulation (EC) No 852/2004, cleanliness of the line and of containers Annex II, Chapter X, point 3 of Regulation (EC) No 852/2004 and, for re-use, verifiable washing procedures Annex II, Chapter X, point 4 of Regulation (EC) No 852/2004 all remain due. For cross-contamination from packaging materials (dusty cardboard next to exposed products) control runs through the prerequisites of Article 4 Article 4(2) of Regulation (EC) No 852/2004.

Penalties

The chapter carries no penalties of its own: penalties are left to the Member States Article 17(2) of Regulation (EC) No 178/2002. In Italy the breach of the general hygiene requirements of Annex II is subject to administrative penalties under Legislative Decree No 193/2007 Article 6 of Italian Legislative Decree No 193/2007; breaches of the FCM rules follow a separate penalty track. The national picture is on the Italian penalties page.

As at the date of this update, there is no Court of Justice of the European Union case-law specifically dedicated to Chapter X of Annex II of Regulation (EC) No 852/2004. Litigation on packaging tends to sit on the food contact materials plane (suitability of the material under Regulation (EC) No 1935/2004 Article 3 of Regulation (EC) No 1935/2004) or on the operator's liability for product contamination, rather than on the hygiene of the operation as such.

The chapter is directly applicable and requires no transposition. Member States act on the penalty side and through official controls Article 9 of Regulation (EU) 2017/625. For Italy: penalties under Legislative Decree No 193/2007 Article 6 of Italian Legislative Decree No 193/2007; the general picture is on the Italy page. The comparison across Member States is in the country pages.