The registration of a food business is required under Regulation (EC) 852/2004.1 Food business establishments handling food of animal origin must, with some limited exceptions, be approved2 where they operate within the following categories:
Meat of domestic ungulates.
Meat from poultry and lagomorphs.
Meat of farmed game.
Wild game meat.
Minced meat, meat preparations and mechanically separated meat (MSM).
Live bivalve molluscs.
Raw milk, colostrum, dairy products and colostrum-based products.
Eggs and egg products.
Frogs’ legs and snails.
Rendered animal fats and greaves.
Treated stomachs, bladders and intestines.
In each category Annex III of Regulation 853/2004 lays down requirements with which food business operators must comply.3 Compliance with relevant requirements of Regulation 853/2004 is required in addition to full compliance with Regulation (EC) 852/2004. Registration is not required for establishments that are subject to approval.
The responsibility for the approval of establishments and subsequent enforcement rests with the local food authority where control does not fall to an official veterinarian.5 The FSA is in practice responsible for slaughterhouses, game handling establishments, and cutting plants placing fresh meat on the market and co-located establishments.
The FSA is also responsible for enforcement in relation to raw cows’ milk intended for direct human consumption.6
2 The Approval of Food Business Establishments
The competent authority7 must establish procedures for food business operators to follow when applying for approval of their establishments in accordance with Regulation (EC) 852/2004, Regulation (EC) 854/2004 or Directive 95/69/EC. On receipt of an application for approval the competent authority must make an on-site visit and must approve an establishment for the activities concerned only if the food business operator has demonstrated that it complies with the relevant requirements of food law.8
The competent authority may grant conditional approval if it appears that the establishment meets all the infrastructure and equipment requirements and full approval only if it appears following an inspection carried out within three months that the establishment meets the other relevant requirements of food law. If clear progress has been made but the establishment still does not meet all of the relevant requirements, conditional approval may continue but must not exceed a total of six months.
The approval of establishments is to be kept under review and where serious deficiencies are identified or production at an establishment has to be stopped repeatedly and the food business operator is not able to provide adequate guarantees regarding future production, procedures to withdraw the establishment's approval must be initiated. An establishment's approval may be suspended if the food business operator can guarantee that it will resolve deficiencies within a reasonable time.
The competent authorities must maintain up-to–date lists of approved establishments and make them available to the public in a manner specified.9 The FSA publishes lists of approved premises under sixteen separate headings each corresponding to a different food sector.
Working within the above requirements the procedure is set out in the FSA’s Food Law Code of Practice (England).10 The FSA has also issued more detailed guidance to local food authority authorised officers on the approval of establishments.11
Local food authorities should request food business operators to submit applications for approval in the appropriate form and the FSA provides a template for this purpose.12 Food business operators must provide all relevant information before an application for approval is determined, which may be obtained from documentation supplied with the application or during the subsequent on-site visit. The legislation allows both natural and legal persons to be an applicant food business operator. The circumstances in which applications are required include:
New build or start-up establishments.
Establishments registered under Regulation (EC) 852/2004 seeking to undertake activities that require approval.
Establishments approved under Regulation (EC) 853/2004 seeking to undertake additional activities that require approval.
Establishments approved under Regulation (EC) 853/2004 seeking to undertake additional activities as a co-located establishment that requires approval by the FSA.
A change in food business operator.13
The local food authority should ensure that it fully considers any exemption that may be afforded to the applicant.14
The on-site visit should take the form of an inspection of the establishment to verify that, where necessary, all systems, procedures and documentation meet the relevant requirements of Regulation (EC) 852/2004 and Regulation (EC) 853/2004.
The food business operator must demonstrate than an establishment fully meets the requirements of Regulation (EC) 852/2004, Regulation (EC) 853/2004 and other requirements of food law relevant to the activities to be undertaken. These cover three broad categories:15
Infrastructure and equipment, including the structure of the premises, equipment and layout.
Other requirements of food law relevant, including those applicable to all food establishments such as procedures for maintaining environmental hygiene, traceability, supervision and training.
HACCP-based food safety management system specific to individual establishments to demonstrate compliance with the requirements of Article 5 of Regulation (EC) 852/2004 concerning the seven HACCP principles.
Where an establishment requires approval it cannot operate until it has been granted conditional approval:
In all circumstances, conditional approval should be granted prior to full approval being granted. This is because it will be impossible for the FBO to demonstrate that the food safety management system is valid and to verify its effectiveness.16
The competent authority should, once conditional or full approval has been granted, notify the food business operator in writing setting out the nature and scope of the approval and any conditions or limitations which may apply. The FSA provides a template for this purpose.17
The local food authority or the FSA, as the case may be, must give an approval number to each food business establishment it approves, either conditionally or fully.18 The approval number is a three digit number unique to that authority and which forms a part of an approval code which consists of the local food authority’s two-letter code followed by the approval number. The approval code is incorporated into an identification mark which an approved establishment is required to apply to its products. The form of the mark is prescribed19 and one example of an acceptable mark is as follows:
The name of the country in which the establishment is located may be written out in full or, as above, the two-letter ISO standard code may be used.
Where an establishment manufactures food to which Regulation 853/2004 applies and food to which it does not, the food business operator may apply the same identification mark to both types of food.
Food business operators must ensure that the relevant competent authority always has up-to-date information on establishments including significant changes in activities and closures of establishments.20
Where an application for approval is refused, the competent authority should notify the applicant in writing of the decision at the earliest opportunity and provide reasons for the refusal, details of the action necessary to satisfy the requirements of the regulations and make it clear that activities requiring approval may not be undertaken unless and until approval or conditional approval has been granted. The food business operator should be informed of their right of appeal21 against the decision and provided with the address of the Magistrates Court where an appeal may be made. The appeal must be made within one month from the date on which notice of the decision to refuse an approval was served. The establishment cannot continue to operate from the date on which notice of the decision is served whilst the appeal is pending.
3 The Exemptions from Approval
3.1 The Direct Supply of Small Quantities of Primary Products
The direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer is exempt from the requirements of Regulation (EC) 853/2004.22
The concept of ‘small quantities’ should be broad enough to allow:23
Farmers to sell primary products directly to the final consumer by means of farm gate sales or sales at local markets, sales to local retail shops directly supplying the final consumer and sales to local restaurants.
Fishermen who harvest live shellfish products and fishery products such as crabs and lobsters to deliver directly to the final consumer or to local retail shops for direct sale to the final consumer and to local restaurants.
The phrase ‘small quantities’ is not defined. The FSA’s guidance to local food authority authorised officers24 suggests the following maximum quantities:
Milk - up to 24 pints (approximately 14 litres) of raw drinking milk per day.
Eggs - less than 360 eggs (one full case) per week in the case of direct supplies to the final consumer from the farm and farmers’ markets and door to door. Sales to local shops, restaurants and bakeries must be graded Class A which is an activity that requires authorisation and approval as a packing centre.25
Fishery products – up to 25 tonnes in a calendar year.
Live bivalve molluscs - up to 25 tonnes in a calendar year, subject to maximum limits for individual species:
Cockles 25 tonnes
Oysters 5 tonnes
King Scallops 5 tonnes
Queen Scallops 10 tonnes
Mussels 20 tonnes
Others 10 tonnes
Marine gastropods 20 tonnes
The direct supply, by the producer, of small quantities of meat from poultry and lagomorphs26 slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer as fresh meat is exempt from the requirements of Regulation (EC) 853/2004.27
The exemption applies to producers of poultry (which excludes ratites such as ostriches and emus), rabbits, hares and rodents who slaughter their own animals on the farm of production. Again, ‘small quantities’ are not defined. The FSA’s guidance suggests the following should be exempt:
Producers slaughtering under 10,000 birds or lagomorphs annually. Year-on-year fluctuations are acceptable provided that the annual slaughtering is typically no more than 10,000. The limit of 10,000 applies to the total number of poultry or lagomorphs slaughtered.
Producers slaughtering over 10,000 birds or lagomorphs annually who are members of an appropriate assurance scheme and who either dry pluck by hand or slaughter for 40 days per year or less. The intention is that these restrictions are self-limiting to small quantities and are for those producers where the assessed public health risk is likely to be low.
The factors to be taken into account in deciding whether an assurance scheme is appropriate include whether the scheme meets the minimum legal requirements in relation to food safety and hygiene and whether it is subject to independent verification.
Meat produced in accordance with this exemption may be supplied direct to the final consumer or direct to local retail establishments directly supplying the meat to the final consumer.
The direct supply to the final consumer includes mail order, internet sales and farmers markets when the supply is direct to the consumer. These supplies are not necessarily limited to meat in the form of fresh meat and may include minced meat, meat products or meat preparations.
The direct supply to local retail establishments of fresh meat, minced meat, meat preparations or meat products could include the supply by the producer to restaurants or other catering establishments. The retail establishments must be local28 and, in addition, anywhere within the UK in the two weeks preceding Christmas and Easter and, for geese, Michaelmas in late September.
A producer who supplies small quantities of meat under this exemption must ensure that it bears a label or other marking clearly indicating the name and address of the farm where the animal from which it is derived was slaughtered.29 Furthermore, the producer must:
Keep a record in adequate form to show the number of birds and the number of lagomorphs received into, and the amounts of fresh meat despatched from, the premises during each week.
Retain the record for a period of one year.
Make the record available to an authorised officer on request.
A producer who fails to comply with any of these requirements is guilty of an offence and is liable on summary conviction to a fine not exceeding the statutory maximum and on conviction on indictment to imprisonment for a term not exceeding two years, to a fine or to both.30
The direct supply by hunters of small quantities of wild game or wild game meat directly to the final consumer or to local retail establishments directly supplying the final consumer is exempt from the requirements of Regulation (EC) 853/2004.31
The exemption is for primary producers, individual hunters and shooting estates, supplying small quantities of wild game carcases in fur or feather directly to the final consumer and to local retail establishments directly supplying the final consumer. The exemption also applies to hunters and active members of a hunting party supplying small quantities of wild game meat directly to the final consumer and local retailers directly supplying the final consumer. The meat must be prepared by an individual who has played an active part in the shoot, such as a beater, so the exemption is available to shooting estates.32
In general, the ‘direct supply’ to a final consumer can be via mail order or internet sales as well as by delivery or collection. The final consumer does not have to be local to the primary producer, but any retail establishments supplied must be local.
3.2 The Retail Exemptions
Unless expressly indicated to the contrary Regulation (EC) 853/2004 does not apply to retail.33 The Regulation does, however, apply to retail when operations are carried out with a view to the supply of food of animal origin to another establishment, unless:
The operations consist only of storage or transport, in which case the temperature requirements laid down in Annex III apply; or
The supply of food of animal origin from the retail establishment is to other retail establishments only and, in accordance with national law, is a marginal, localised and restricted activity.
The definition of ‘retail’ includes ‘wholesale outlets’34 but the broader terms ‘wholesale’, ‘wholesale activities’ or similar are not used. An establishment supplying its customers on a ‘cash and carry’ basis is included in the retail exemption, so long as an element of that supply is to the final consumer.
The FSA offer the following interpretations of ‘marginal’, ‘localised’ and ‘restricted’.
The supply of products of animal origin is ‘marginal’ where up to a quarter of the establishment’s annual turnover in food is in such products or, in relation to meat (fresh or processed, excluding wild game meat) up to 2 tonnes a week (averaged over a 12 month period) where the establishment has a genuine retail element to its operation.35
Sales are ‘localised’ when they take place within the county in which the establishment is located plus the greater of either the neighbouring county or counties or 30 miles (50km) from the boundary of the supplying establishment’s county. In exceptional circumstances, ‘localised’ may include the whole of the UK in cases where the geographical distribution of certain farmed or game animals would otherwise significantly restrict the national supply (for example, rare breeds meat and grouse) or where a traditional, rare or high value product could not find a sufficient and/or specialist market on a local basis.
The supply is restricted when it concerns “only certain types of products or establishments”.36 The FSA guidance states:
This only applies to the supply of wild game. Supply is subject to the game having been examined by a trained person and carcases of large wild game animals must be accompanied by a trained person’s declaration stating that no abnormalities were observed either before or after shooting. For all other meat, the restrictions relate to the amount of meat supplied.37
3.3 Supply by the Producer to the Final Consumer at Farmers’ Markets
Establishments producing products of animal origin for supply to the final consumer at farmers’ markets, or at other markets supplying the final consumer, are not subject to approval under Regulation (EC) 853/2004 subject to the following conditions:38
There is no change of control so, for example, farmer A cannot cut meat and supply it to farmer B to sell at the market.
It does not involve supply to other than the final consumer. The supply to shops or restaurants would render the establishment subject to approval if supply was above the marginal, local and restricted limits.
In practice, markets are treated as an extension of the producer’s establishment and as sales to the final consumer are not limited to the ‘localised’ sale criteria.
3.4 Composite Products
Regulation (EC) 853/2004 does not apply to food containing both products of plant origin and processed products of animal origin. However, processed products of animal origin used to prepare such food must be obtained and handled in accordance with the requirements of the Regulation.39
A food business operator who merely assembles processed products of animal origin with products of plant origin does not need approval since it is a composite product.
The further processing of a processed product of animal origin prior to combining it with food of plant origin would need approval under Regulation (EC) 853/2004 for the further processing since it is not, at that stage, a composite product. The subsequent combining of the processed product with product of plant origin does not need approval.40
The combining of food of plant origin with unprocessed food of animal origin which is further processed together requires approval under Regulation (EC) 853/2004 since it is not a composite product.
The addition of a product of plant origin to a processed product of animal origin does not automatically mean that the resulting food would be a composite product. The addition of herbs to cheese, fruit to yoghurt or garlic to sausage are all examples of products whose manufacture must be performed under the requirements of Regulation (EC) 853/2004.41
1 Regulation (EC) 853/2004, Article 6(2)
2 Ibid., Article 4(2)
3 Ibid., Article 3(1)
4 April 2012, p102, para 5.1.6ff
5 Regulation (EC) 854/2004, Article 4(7)
6 The Food Hygiene (England) Regulations 2006 SI 2006/14, Schedule 6
7 The central authority, the Food Standards Agency, of an EU member state competent for the organisation of official controls or any other authority, a local food authority, on which that competence has been conferred.
8 Regulation (EC) 882/2004, Article 31(2)(a)
9 Ibid., Articles 31(2)(f) and 62(3) and European Commission, Technical Specifications in Relation to the Master List and the Lists of EU Approved Food Establishments, SANCO/2179/2005 Revision 5, 2005
10 April 2012, p102, para 5.1.6ff
11 Food Standards Agency, Guidance for Local Authority Authorised Officers on the Approval of Establishments, 2012
13 Food Standards Agency, Guidance for Local Authority Authorised Officers on the Approval of Establishments, 2012, p31, para 102
14 Regulation (EC) 853/2004, Article 1
15 Article 31(2)(d)
16 Food Standards Agency, Guidance for Local Authority Authorised Officers on the Approval of Establishments, 2012, p23, para 47
18 Regulation (EC) 854/2004, Article 3(3)
19 Regulation (EC) 853/2004, Annex II, Section IB, points 5 to 8
20Regulation 852/2004, Article 6(2)
21 Official Feed and Food Controls (England) Regulations 2009 SI 2009/3255, r12 as amended by The Official Feed and Food Controls (England) (Amendment) Regulations 2011 SI 2011/136 which revoked r12(5) to (7).
22 Regulation (EC) 853/2004, Article 1(3)(c)
23 Food Standards Agency, Guidance for Local Authority Authorised Officers on the Approval of Establishments, 2012, p13, para 7(i)
24 Ibid., pp13-14, para 7(i)
26 Rabbits, hares and rodents.
27 Article 1(3)(d)
31 Regulation (EC) 853/2004, Article 1(3)(e)
32 Food Standards Agency, Guidance for Local Authority Authorised Officers on the Approval of Establishments, 2012, p15, para 7
33 Regulation (EC) 853/2004, Article 1(5)
34 Regulation (EC) 178/2002, Article 3(7)
35 Food Standards Agency, Guidance for Local Authority Authorised Officers on the Approval of Establishments, 2012, p16, para 12 and Food Standards Agency, Food Law Practice Guidance (England), October 2012, p115, para A.3.4.2
36 Regulation (EC) 853/2004, recital 13
38 Food Standards Agency, Guidance for Local Authority Authorised Officers on the Approval of Establishments, 2012, p17, paras 13 and 14.
39 Regulation (EC) 853/2004, Article 1(2)
40 Regulation (EC) 852/2004 applies here and in the previous case.
41 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