Articles 10-11 of Regulation (EC) No 852/2004 — Imports and exports

Rationale and origin

Articles 10 and 11 close the body of the Regulation with two coordination rules linking Regulation (EC) No 852/2004 to the framework food law, Regulation (EC) No 178/2002. The legislature did not build a separate hygiene regime for goods crossing the Union's border. Instead, it made clear that the substantive requirements of Articles 3 to 6 form part of those "relevant requirements of food law" that Regulation 178/2002 makes applicable to imported and exported food. The drafting technique is cross-reference: Articles 10 and 11 add no obligations but establish an equivalence of content, so that food hygiene is no less protected when the food comes from, or is destined for, a third country.

The premise is the principle, set in Regulation 178/2002, that food imported for placing on the Union market must comply with the relevant requirements of food law or with conditions recognised by the Union to be at least equivalent Article 11 of Regulation (EC) No 178/2002; symmetrically, food exported or re-exported must comply with the relevant requirements, unless the authorities of the importing country require otherwise or the agreements and rules of the country of destination provide otherwise Article 12 of Regulation (EC) No 178/2002. Articles 10 and 11 of Regulation 852/2004 state that this "relevant" content also includes the Regulation's hygiene requirements.

Personal scope

The two provisions do not identify a new addressee: they speak to the same food business operators (FBOs) bound by the rest of the Regulation. An importer established in the Union is an FBO at the distribution stage and, as such, subject to the general hygiene obligation Article 3 of Regulation (EC) No 852/2004, to the applicable requirements of Annex II, and to HACCP-based self-checking Article 5(1) of Regulation (EC) No 852/2004. An exporter established in the Union is likewise an FBO subject to the same duties for the part of the chain carried out on Union territory. Article 10 does not transfer obligations to the third-country producer — who is not a direct addressee of the Regulation — but makes the Union hygiene standard the yardstick for the conformity of imported goods.

Material scope

The object of the cross-reference is, textually, "the requirements laid down in Articles 3 to 6": the general hygiene obligation Article 3 of Regulation (EC) No 852/2004, the general and specific requirements of Annex I and Annex II Article 4(1) of Regulation (EC) No 852/2004, HACCP-based permanent procedures Article 5(1) of Regulation (EC) No 852/2004 and the duties of official control, notification for registration or approval of establishments Article 6(2) of Regulation (EC) No 852/2004. The scope is hygiene: Articles 10 and 11 do not touch non-hygiene matters (labelling, additives, contaminants), which follow their own instruments.

One boundary must be noted. Regulation 852/2004 governs the hygiene of all food; the specific rules for products of animal origin are in Regulation (EC) No 853/2004 Article 1 of Regulation (EC) No 853/2004, which lays down further conditions for the import of such products. Articles 10 and 11 must therefore be read as the "general hygiene" component of a wider system.

Coordination with other rules

The operational centre of gravity has shifted over time. When Regulation 852/2004 was adopted, official controls on imports were organised by instruments that are no longer in force. Since 14 December 2019 the matter has been governed by Regulation (EU) 2017/625 on official controls, which regulates controls on animals and goods entering the Union, border control posts and official certification Article 1 of Regulation (EU) 2017/625. This is the instrument that gives practical effect to the principle of Articles 10 and 11: it verifies that imported food also complies with the hygiene requirements of Articles 3 to 6. In our view, this is where the most common error of commentators lies: many still cite the repealed official-control regulations. Regulation 2017/625 replaced them.

On the export side, the reference to Article 12 of Regulation 178/2002 introduces a flexibility that imports lack: where food is intended for export to a third country, the requirements agreed with or requested by the authorities of the importing country prevail, if any Article 12 of Regulation (EC) No 178/2002. It remains, however, that food injurious to health may not be exported.

Practical application and interpretive knots

"Import" in a hygiene sense, not a customs sense. Articles 10 and 11 do not create duties, quotas or customs procedures: they fix the equivalence of the substantive standard. The health documentation accompanying the goods and the checks at the border control post flow from Regulation 2017/625, not from these two articles.

No import/export certificate under Regulation 852/2004. The Regulation provides for no document called a certificate for import/export purposes; conformity with Articles 3 to 6 is demonstrated as for any Union FBO and, on import, is subject to official control. Anyone promising a title "valid to export throughout the Union" conflates distinct planes.

Equivalence, not identity. For imports, Article 11 of Regulation 178/2002 allows, as an alternative to full compliance with Union law, conditions recognised by the Union to be at least equivalent Article 11 of Regulation (EC) No 178/2002. Equivalence is a Union assessment, not a free self-declaration by the operator.

Penalties

Articles 10 and 11 carry no penalties of their own. Breaches of the hygiene obligations referred to (Articles 3 to 6) are penalised by the Member States with effective, proportionate and dissuasive measures Article 17(2) of Regulation (EC) No 178/2002. On import, Regulation 2017/625 also governs the measures the competent authority takes where goods entering the Union are non-compliant, up to refusal or destruction. National penalty frameworks are covered in the country pages.

As at the update date of this page, there is no Court of Justice of the European Union case-law specifically devoted to Articles 10 and 11 of Regulation (EC) No 852/2004. The hygiene of imported food has been addressed by the Union courts mainly through official controls and safeguard measures, now consolidated in Regulation (EU) 2017/625 Article 1 of Regulation (EU) 2017/625.

Articles 10 and 11 are directly applicable and require no transposition. Practical implementation runs through official controls on imports, organised uniformly by Regulation (EU) 2017/625 Article 1 of Regulation (EU) 2017/625 and carried out by the national competent authorities. Member States act through penalties for breach of the hygiene obligations Article 17(2) of Regulation (EC) No 178/2002. The operational picture per Member State is in the country pages.