Flexibility for small businesses in Regulation (EC) 852/2004

The principle: recital 15

Flexibility is a constitutive feature of the Hygiene Package, not a later concession. Recital 15 of Regulation (EC) 852/2004 — the interpretive context declared by the legislator — states that the HACCP requirements should take account of the principles of the Codex Alimentarius and provide sufficient flexibility to be applicable in all situations, including small businesses. The same recital acknowledges that in certain businesses it is not possible to identify critical control points and that, in some cases, good hygiene practices can replace the monitoring of CCPs; it further clarifies that the requirement to establish "critical limits" does not imply fixing a numerical limit in every case, and that the obligation to retain documents must be flexible so as not to place an undue burden on very small businesses.

Flexibility already within Article 5

Much of the flexibility requires no further act: it is built into Article 5. Point (g) of paragraph 2 requires documents and records "appropriate to the nature and size of the food business" Article 5(2) of Regulation (EC) No 852/2004; paragraph 4(a) leaves the manner to the requirements of the competent authority, "taking into account the nature and size of the business" Article 5(4) of Regulation (EC) No 852/2004. Commission Notice 2022/C 355/01 translates these principles into operational guidance: for simple activities (catering and retail), well-managed prerequisites, supplemented where necessary by a simplified HACCP based on sector guides, can satisfy the obligation of paragraph 1 where CCPs cannot or need not be identified. The food safety management manual of a small business is therefore leaner, but not absent.

Derogations and national measures: Article 13

Beyond internal proportionality, Article 13 opens two formal channels of flexibility.

Commission derogations (paragraph 2). The Commission may grant derogations from Annexes I and II, in particular to facilitate the application of Article 5 for small businesses, taking into account the relevant risk factors and provided the derogations do not affect the objectives of the Regulation Article 13(2) of Regulation (EC) No 852/2004.

National adapting measures (paragraphs 3-7). Member States may adopt national measures adapting the requirements of Annex II, without compromising the objectives of the Regulation Article 13(3) of Regulation (EC) No 852/2004. Such measures pursue two typical aims: enabling the continued use of traditional methods at any stage of production, processing or distribution of food; or accommodating the needs of businesses in regions subject to special geographical constraints; in other cases they apply only to the construction, layout and equipment of establishments Article 13(4) of Regulation (EC) No 852/2004. A Member State intending to adopt them notifies the Commission and other Member States, describing the requirements to be adapted, the foodstuffs and establishments concerned and the reasons, including a summary of the hazard analysis Article 13(5) of Regulation (EC) No 852/2004. A consultation phase follows and, where necessary, action by the Commission Article 13(6) of Regulation (EC) No 852/2004 Article 13(7) of Regulation (EC) No 852/2004. It is on this basis that, for example, maturing in traditional environments or mountain-pasture production are protected.

A firm limit: not an exemption

In our view, the most widespread misconception is reading flexibility as a dispensation from the obligations. It is not. Hazard analysis remains due at all times: flexibility affects the how (intensity of documentation, presence or absence of CCPs, structural adaptation), not the whether of self-monitoring. The choice not to identify CCPs, or to replace their monitoring with good hygiene practices, must be justified within the hazard analysis and remains open to review by the competent authority Article 5(4) of Regulation (EC) No 852/2004. National measures, moreover, cannot compromise the objectives of the Regulation Article 13(3) of Regulation (EC) No 852/2004. Application diverges between Member States: the measures adopted must be checked country by country (see country pages).