Annex I, Part B of Regulation (EC) No 852/2004 — Recommendations for guides to good hygiene practice
Updated 2026-07-12 · Consolidated text as of 2021-03-24 · Reviewed by: Redazione ce85204 — revisione editoriale assistita da AI (2026-07-12)
Annex I, Part B of Regulation (EC) No 852/2004 recommends the content of guides to good hygiene practice for primary production: mycotoxins and heavy metals, use of water, fertilisers, plant protection and veterinary products, feed traceability, and record-keeping. It is not binding: it steers the national and Union guides under Articles 7-9.
1National and Community guides referred to in Articles 7 to 9 of this Regulation should contain guidance on good hygiene practice for the control of hazards in primary production and associated operations.
2Guides to good hygiene practice should include appropriate information on hazards that may arise in primary production and associated operations and actions to control hazards, including relevant measures set out in Community and national legislation or national and Community programmes. Examples of such hazards and measures may include:
(a) the control of contamination such as mycotoxins, heavy metals and radioactive material;
(b) the use of water, organic waste and fertilisers;
(c) the correct and appropriate use of plant protection products and biocides and their traceability;
(d) the correct and appropriate use of veterinary medicinal products and feed additives and their traceability;
(e) the preparation, storage, use and traceability of feed;
(f) the proper disposal of dead animals, waste and litter;
(g) protective measures to prevent the introduction of contagious diseases transmissible to humans through food, and any obligation to notify the competent authority;
(h) procedures, practices and methods to ensure that food is produced, handled, packed, stored and transported under appropriate hygienic conditions, including effective cleaning and pest-control;
(i) measures relating to the cleanliness of slaughter and production animals;
(j) measures relating to record-keeping.
At a glance
- Part B imposes no obligations: it recommends the content that guides to good hygiene practice under Articles 7 to 9 should have for hazard control in primary production Annex I, Part B, point 1 of Regulation (EC) No 852/2004.
- It lists, by way of example, hazards and control measures: mycotoxins, heavy metals and radioactive material; use of water, organic waste and fertilisers; use and traceability of plant protection products, biocides, veterinary medicinal products and feed Annex I, Part B, point 2 of Regulation (EC) No 852/2004.
- It is the instrument through which the legislature promotes, on a voluntary basis, the extension of good practice to the primary stage, which is exempt from the HACCP obligation of Article 5 Article 5(3) of Regulation (EC) No 852/2004.
- Guides may be national, drawn up under Article 8, or Union-level, drawn up under Article 9 Article 8(1) of Regulation (EC) No 852/2004.
Commentary
Rationale and origin
Part B closes Annex I in a register different from that of Part A: it does not prescribe, it recommends. The verb of the whole part is "should", which in the Regulation's language signals guidance and not an obligation. The reason is consistent with the overall design: because primary production is exempt from the obligation to put in place permanent procedures based on the HACCP principles under Article 5 Article 5(3) of Regulation (EC) No 852/2004, the legislature entrusts the guides to good practice — voluntary instruments — with guiding producers in hazard control, and here sets out the recommended minimum content.
Material scope: the recommended content
Point 1 sets the function: national or Union guides under Articles 7 to 9 should contain guidance on good hygiene practice for the control of hazards in primary production and associated operations Annex I, Part B, point 1 of Regulation (EC) No 852/2004. Point 2 lists, "for example", hazards and measures the guides should cover Annex I, Part B, point 2 of Regulation (EC) No 852/2004:
| Point | Hazard or measure |
|---|---|
| (a) | Contamination by mycotoxins, heavy metals and radioactive material |
| (b) | Use of water, organic waste and fertilisers |
| (c) | Correct use and traceability of plant protection products and biocides |
| (d) | Correct use and traceability of veterinary medicinal products and feed additives |
| (e) | Preparation, storage, use and traceability of feed |
| (f) | Proper disposal of dead animals, waste and litter |
| (g) | Protective measures against diseases transmissible to humans and the duty to notify the competent authority |
| (h) | Procedures and methods to produce, handle, pack, store and transport under hygienic conditions, with cleaning and pest control |
| (i) | Cleanliness of slaughter and production animals |
| (j) | Record-keeping |
The list is not exhaustive ("examples … may include") and mirrors, at the level of the guides' content, the operational duties of Part A Annex I, Part A, point 4 of Regulation (EC) No 852/2004. The theme of traceability of inputs and products recurs throughout (points c, d, e), tying Part B to the general traceability duty of food law Article 18 of Regulation (EC) No 178/2002 and to the record-keeping required by section III of Part A Annex I, Part A, point 7 of Regulation (EC) No 852/2004.
Coordination with other rules
Part B expressly refers to the system of guides to good practice governed by Chapter III of the Regulation: drawing up and use Article 7 of Regulation (EC) No 852/2004, national guides assessed by the Member State Article 8(1) of Regulation (EC) No 852/2004 and Union guides Article 9(1) of Regulation (EC) No 852/2004. On the management side, the recommended content feeds, for downstream stages, into the food safety management manual based on the HACCP principles of Article 5 Article 5(1) of Regulation (EC) No 852/2004.
Practice
Guides to good practice for primary production have been adopted in many Member States for specific sectors (fruit and vegetables, raw milk, eggs, beekeeping, fisheries). Their adoption remains voluntary, but adherence to a validated guide makes it easier to demonstrate compliance with the requirements of Part A during official controls Annex I, Part A, point 6 of Regulation (EC) No 852/2004. In our view Part B's practical value is twofold: it offers a checklist of the hazards typical of the primary stage, and it standardises the expected content of the guides, reducing divergence between sectors and territories.
Penalties
Being recommendations, Part B is not itself a source of enforceable obligations. Penalties concern breaches of the binding requirements of Part A and are a national matter Article 17(2) of Regulation (EC) No 178/2002. A comparative summary is in the countries section.
Case law
As at the date of this update, there is no Court of Justice of the European Union ruling on Annex I, Part B of Regulation (EC) No 852/2004. The recommendatory nature of the provision limits its direct justiciability; litigation in this field rather concerns the binding requirements of Part A.
Implementation in the Member States
Part B requires no transposition: it operates through the guides to good practice that Member States draw up and assess under Article 8 Article 8(1) of Regulation (EC) No 852/2004 and that the Commission may draw up at Union level under Article 9 Article 9(1) of Regulation (EC) No 852/2004. A country-by-country view is in the countries section.
Common errors
- Treating Part B as an obligation. The text uses "should" and works as a recommendation on the content of the guides Annex I, Part B, point 1 of Regulation (EC) No 852/2004: the binding obligations are in Part A Annex I, Part A, point 2 of Regulation (EC) No 852/2004.
- Confusing guides to good practice with the HACCP manual. Primary-stage guides are voluntary guidance instruments Article 7 of Regulation (EC) No 852/2004; the self-check plan based on the HACCP principles is mandatory only from stages after primary production Article 5(3) of Regulation (EC) No 852/2004.
- Reading the point 2 list as exhaustive. The rule introduces the hazards and measures with "examples … may include" Annex I, Part B, point 2 of Regulation (EC) No 852/2004: guides can and should also cover further hazards relevant to the sector.
Frequently asked questions
Is Part B of Annex I binding?
No. It contains recommendations on the content that guides to good practice should have Annex I, Part B, point 1 of Regulation (EC) No 852/2004. The binding obligations for primary production are in Part A Annex I, Part A, point 2 of Regulation (EC) No 852/2004.
What should guides to good practice for primary production contain?
Guidance on controlling the hazards typical of the primary stage: mycotoxins, heavy metals and radioactive material; use of water, waste and fertilisers; use and traceability of plant protection products, biocides, veterinary medicinal products and feed; disposal of dead animals and waste; measures against transmissible diseases; hygienic procedures and record-keeping Annex I, Part B, point 2 of Regulation (EC) No 852/2004.
Who draws up guides to good practice?
National guides are drawn up by the sectors of the food industry and assessed by the Member State under Article 8 Article 8(1) of Regulation (EC) No 852/2004; Union guides are drawn up with the involvement of the Commission under Article 9 Article 9(1) of Regulation (EC) No 852/2004.
Why does primary production have guides instead of HACCP?
Because the obligation to put in place permanent procedures based on the HACCP principles under Article 5 does not apply to primary production Article 5(3) of Regulation (EC) No 852/2004. The legislature promotes hazard control at this stage through voluntary guides to good practice Annex I, Part B, point 1 of Regulation (EC) No 852/2004.
Is adopting a guide to good practice mandatory?
No, adoption is voluntary Article 7 of Regulation (EC) No 852/2004. Adherence to a validated guide does, however, make it easier to demonstrate compliance with the requirements of Part A during official controls Annex I, Part A, point 6 of Regulation (EC) No 852/2004.
Sources
- EUR-Lex — Regulation (EC) No 852/2004, text consolidated as of 24 March 2021 (CELEX 02004R0852-20210324): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02004R0852-20210324 — accessed 2026-07-12.
- EUR-Lex — Regulation (EC) No 178/2002, Article 18 (traceability): https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02002R0178-20240701 — accessed 2026-07-12.
Drafting and review
ce85204 editorial team. Draft generated with AI from primary sources; editorial review assisted by AI (see methodology).