While Regulation (EC) 852/2004 lays down general rules on the hygiene of foodstuffs, Regulation (EC) 853/2004 lays down specific hygiene rules for food of animal origin. Food business operators which must comply with Regulation (EC) 853/2004 must also comply with Annex II of Regulation (EC) 852/2004. In relation to the former:
The principal objectives … are to secure a high level of consumer protection with regard to food safety, in particular by making food business operators throughout the Community subject to the same rules, and to ensure the proper functioning of the internal market in products of animal origin, thus contributing to the achievement of the objectives of the common agricultural policy.1
2 The Scope of Regulation (EC) 853/2004
Regulation (EC) 853/2004 supplements the rules laid down by Regulation (EC) 852/2004 and they shall apply to unprocessed and processed products of animal origin. In which ‘unprocessed products’ are:
… foodstuffs that have not undergone processing, and includes products that have been divided, parted, severed, sliced, boned, minced, skinned, ground, cut, cleaned, trimmed, husked, milled, chilled, frozen, deep-frozen or thawed.2
The act of ‘processing’ means any action that substantially alters the initial product, including heating, smoking, curing, maturing, drying, marinating, extraction, extrusion or a combination of processes3 and which results in ‘processed products’ namely:
… foodstuffs resulting from the processing of unprocessed products. These products may contain ingredients that are necessary for their manufacture or to give them specific characteristics.4
When applied to ‘products of animal origin’ namely:
Food of animal origin, including honey and blood.
Live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods intended for human consumption.
Other animals destined to be prepared with a view to being supplied live to the final consumer.5
So that a non-exhaustive list of unprocessed (or raw) products of animal origin6 includes:
Fresh meat/minced meat/Mechanically Separated Meat.
Untreated intestines, stomachs and bladders.
Meat preparations that have not been processed.
Fresh fishery products.
Live bivalve molluscs, live echinoderms, live tunicates and live marine gastropods.
Whole eggs and liquid egg.
An unprocessed product with a product of plant origin remains a raw product, for example, a skewer containing fresh meat and vegetables and preparations of fresh fishery products (such as fish fillets) with food of plant origin.
Processed ‘meat products’ means processed products resulting from the processing of meat or from the further processing of such processed products, so that the cut surface shows that the product no longer has the characteristics of fresh meat7 and includes ham, salami, etc.
‘Dairy products’ means processed products resulting from the processing of raw milk or from the further processing of such processed products and includes heat treated milk, cheese, yoghurt, etc.
‘Egg products’ means processed products resulting from the processing of eggs, or of various components or mixtures of eggs, or from the further processing of such processed products.
‘Processed fishery products’ means processed products resulting from the processing of fishery products or from the further processing of such processed products and includes smoked fish, marinated fish, etc.
‘Rendered animal fat’ means fat derived from rendering meat, including bones, and intended for human consumption.
‘Greaves’ means the protein-containing residue of rendering, after partial separation of fat and water.
‘Gelatine’ means natural, soluble protein, gelling or non-gelling, obtained by the partial hydrolysis of collagen produced from bones, hides and skins, tendons and sinews of animals.
‘Collagen’ means the protein-based product derived from animal bones, hides, skins and tendons manufactured in accordance with the relevant requirements of this Regulation.
‘Treated stomachs, bladders and intestines’ means stomachs, bladders and intestines that have been submitted to a treatment such as salting, heating or drying after they have been obtained and after cleaning.
Processed products also include a combination of processed products, for example, cheese with ham, and products that have undergone several processing operations, for example, cheese from pasteurised milk.
Regulation (EC) 853/2004 does not apply to food containing both products of plant origin and processed products of animal origin, any risks posed are adequately addressed in compliance with Regulation (EC) 852/2004. However, processed products of animal origin used to prepare such food must be obtained and handled in accordance with the requirements of the former Regulation.9 So, for example, meat and dairy products used to prepare ready-to-eat meals composed of such processed products and vegetables must have been obtained in accordance with Regulation (EC) 853/2004, but the manufacture of these ready-to-eat meals falls under Regulation (EC) No 852/2004.10
Finally, Regulation (EC) 853/2004 does not apply to retail unless expressly indicated to the contrary.11
3 Official Controls and Enforcement
The rules governing the organisation of official controls on products of animal origin intended for human consumption are contained in Regulation (EC) 854/2004 which is to be read in conjunction with implementing Regulation (EC) 2074/2005. The competent authorities are required to ensure that food business operators comply with their obligations and involves the auditing of good hygiene practice and critical control point HACCP-based procedures. In order to fulfil this responsibility the competent authorities must ensure that food business operators offer all the assistance needed to ensure that official controls carried out by the competent authority can be performed effectively. In particular, food business operators must:
Give access to all buildings, premises, installations or other infrastructures.
Make available any documentation and record required under Regulation (EC) 854/2004 or considered necessary by the competent authority for judging the situation.
Regulation (EC) 854/2004 applies in addition to Regulation (EC) 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules in respect of activities and persons to which Regulation (EC) 853/2004 applies.12
There is specific provision for official controls in relation to fresh meat,13 live bivalve molluscs,14 fishery products15 and raw milk and dairy products.16 These are more fully dealt with in the documents covering these products.
3 Ibid., Article 2(1)(m)
4 Ibid., Article 2(1)(o)
6 European Commission, Guidance Document on the Implementation of Certain Provisions of Regulation (EC) No 853/2004 on the Hygiene of Food of Animal Origin, 16 February 2009, Annex I
7 Ibid., Annex I, Section 7.1
8 Ibid., Annex I, Section 7.2 to 7.9
10 European Commission, Guidance Document on the Implementation of Certain Provisions of Regulation (EC) No 853/2004 on the Hygiene of Food of Animal Origin, 16 February 2009, p5, para 3.4
11 Op. cit., Article 5(a)
13 Ibid., Article 5 and Annex I
14 Ibid., Article 6 and Annex II
15 Ibid., Article 7 and Annex III
16 Ibid., Article 8 and Annex IV