1 Introduction
This document concentrates on the specific provisions which apply to raw drinking milk. It should be read in conjunction with Milk, Milk Products and Drinking Milk which sets out the regulations concerning milk production throughout Europe.
Under Article 10(8) of Regulation (EC) 853/2004 laying down specific hygiene rules for food of animal origin, individual member states may prohibit or restrict the availability within their territory of raw milk or raw cream intended for direct human consumption. Raw cream is covered in Cream and Raw Cream.
Marketing standards for milk and milk products are subject to Regulation (EC) No 1234/2007, which establishes a common organisation of agricultural markets, in particular Article 114, Annex XII and XIII. The Regulation is supplemented and enforced by The Drinking Milk (England) Regulations 2008.1 Milk and cream, not concentrated nor containing added sugar or other sweetening matter2 may only be marketed in accordance with the requirements of Annex XIII. The regulations are covered in Milk, Milk Products and Drinking Milk.
There are additional provisions specific to raw milk which are contained in the Food Hygiene (England) Regulations 20063 and The Food Labelling Regulations 1996.4
2 Definition and Requirements
‘Milk’ is the produce of the milking of one or more cows5 and ‘drinking milk’, where intended for delivery without further processing to the consumer, includes ‘raw milk’ defined6 as milk which has not been heated above 40oC or subjected to treatment having equivalent effect.
In all cases, including raw milk, drinking milk shall:
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Have a freezing point close to the average freezing point for raw milk recorded in the area of origin of the drinking milk collected.
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Have a mass not less than 1028 grams per litre for milk containing 3.5% (m/m) of fat at a temperature of 20oC or the equivalent weight per litre for milk having a different fat content.
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Contain a minimum 2.9% (m/m) of protein for milk containing 3.5 % (m/m) fat or an equivalent concentration in the case of milk having a different fat content.7
Under Regulation (EC) 1234/2007 only milk complying with these requirements may be delivered or sold without processing to the final consumer, either directly or through the intermediary of restaurants, hospitals, canteens or other similar mass caterers. The sales description to be used is that of ‘raw milk’ and in England the Food Hygiene (England) Regulations 2006 makes provision for strict controls over the sale and distribution of raw milk and the standards it must meet.
The Drinking Milk (England) Regulations 2008 provide that no person may sell or deliver milk, use or omit to use a sales description in contravention of the requirements laid down for drinking milk or those relating to sales descriptions.8 Any person who does so commits an offence and is liable on summary conviction to a fine up to level 5 on the standard scale.9
A number of provisions of the Food Safety Act 1990 apply for the purposes of the 2008 Regulations10, including the extended meaning of sale, presumption that food is intended for human consumption, offences committed due to the default of another and the defence of due diligence.11
3 Restrictions on the Sale of Raw Drinking Milk Intended for Direct Human Consumption
A ‘milk production holding’ means an establishment where one or more farmed animals are kept to produce milk with a view to placing it on the market as food12 and such establishments are subject to official controls.13
The occupier of premises at which milk-producing cows are kept may only sell raw cows' milk intended for direct human consumption:
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At or from the farm premises where the animals from which the milk has been obtained are maintained; and
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To the final consumer for consumption other than at those farm premises, a temporary guest or visitor to those farm premises as or as part of a meal or refreshment, or a distributor.14
The ‘occupier’ means any person carrying on the business of producing or handling raw cows' milk or his duly authorised representative.
‘Farm premises’ means a farm occupied by the occupier of a production holding as a single farm and includes the production holding and any other building situated on that farm and occupied by the same occupier.
A ‘distributor’ means a person who sells raw cows' milk that has been produced on a production holding of which he is not the occupier. A distributor may only sell raw cows' milk intended for direct human consumption:
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Which has been bought in the circumstances described in paragraphs a) and b) above.
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In the containers in which the milk was received, with the fastenings of the containers unbroken.
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From a vehicle which is lawfully used as a shop premises; and
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Direct to the final consumer.
A key question to consider is what in practice does “from the farm premises” mean? The Food Standards Agency acknowledges that sales at a local market are permitted and, furthermore, that:
Raw milk producers are using new routes of sale for raw drinking milk with at least two producers in England offering internet sales. This is permitted under current domestic controls but is not within the spirit of the legislation as these controls were developed to only allow restricted sales and only to a local market. Other producers are exploring sale through vending machines which, based on discussions in European Commission Working Groups, is following practices in some other EU countries such as Italy. Sales from vending machines on farm premises or at a farmers market would be permitted under current domestic controls in England, Wales and Northern Ireland but vending machines cannot be placed in retail outlets.15
The result appears somewhat absurd. The FSA’s view of the legislation remains untested. The prosecution brought by the FSA in 2013 against a farmer in connection with vending machine sales in a London food store was dropped. The current FSA review of controls over raw drinking milk sales may well result in changes to the present legislative framework.
Any person, other than the occupier of a production holding or a distributor, who sells raw cows' milk intended for direct human consumption commits an offence. The occupier of a production holding who sells raw cows' milk intended for direct human consumption in contravention the first mentioned paragraphs 1) and 2) above commits an offence and a distributor who sells raw cows' milk intended for direct human consumption in contravention of paragraphs 1) to 4) above commits an offence.16
4 Hygiene Rules
4.1 Primary Production Rules
Hygiene rules in relation to primary production are more extensively covered in the section on Food Hygiene. A summary of the provisions relevant to milk production are included in the document on Milk, Milk Products and Drinking Milk.
More detailed rules are contained in Regulation (EC) 853/2004 concerning the health requirements for raw milk and colostrums production.17 In the UK raw milk must also meet the following standards:
Plate count at 300C (cfu per ml) | ≤ 20,000 |
Coliforms (cfu per ml) | < 100 |
The Food Standards Agency is required to carry out such sampling, analysis and examination of raw milk it considers necessary to ensure that these standards are met and in respect of which a fee of £63 is due.18 In practice compliance is monitored through a system of twice yearly inspections, milk is also sampled and tested quarterly under the supervision of the FSA to ensure compliance with the standards for total bacterial count and coliforms.
Any person who sells raw milk intended for direct human consumption in contravention of these standards is guilty of an offence punishable on summary conviction with a fine up to level 5.19
4.2 Responsibilities for the Enforcement of Hygiene Legislation for Milk
The FSA takes the lead role in connection with hygiene legislation relating to milk and milk production, including on farm incidents putting milk or milk products at risk of tuberculosis contamination. Defra’s Animal Health and Veterinary Laboratories Agency is responsible for tuberculosis (TB) infection in cattle and used to undertake the necessary enforcement inspections on behalf of the FSA, but since 1 April 2012 hygiene inspections in England and Wales have been carried out by FSA staff.
5 Labelling Milk and Misleading Descriptions
The general requirements set out under The Food Labelling Regulations 1996 are covered in Sales, Advertising and Labelling, but there are a number of specific provisions which apply to raw drinking milk dealt with here.
The 1996 Regulations apply generally to food which is ready for delivery to the ultimate consumer or to a catering establishment20 and ‘milk’ means the milk intended for sale, or sold, for human consumption of:
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One or more cows, and includes skimmed, semi-skimmed and whole milk; or
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One or more ewes, goats or buffaloes.21
‘Raw milk’ is further defined for the purposes of the 1996 Regulations, in relation to cows' milk, as having the meaning assigned to it by Regulation (EC) 1234/200722 and, in relation to the milk of ewes, goats or buffaloes means milk which has neither been heat-treated beyond 400C nor undergone any treatment having the same effect.
Milk which is prepacked for direct sale is not subject to the general labelling requirement23 except for the name of the food and the requirement that it be marked or labelled with particulars of the place of origin or provenance of the food if failure to give such particulars might mislead a purchaser to a material degree as to the true origin or provenance of the food. In the case of raw milk the name or business name and an address or registered office of the manufacturer or packer must be provided.24
In the case of cows’ milk, ‘prepacked for direct sale’ means put into containers on the premises where the milk is produced by the person owning or having control of the herd from which the milk is produced for sale on those premises or from a vehicle or stall.25 Where milk is contained in a bottle, any particulars required to be given may be stated on the bottle cap.26
The 1996 Regulations prohibit a range of misleading food descriptions. In regard to milk, the word 'milk' or any other word or description which implies that the food being described contains milk must not be used as part of the name of a food that contains the milk of an animal other than a cow, unless:
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The milk has all the normal constituents in their natural proportions and the word or description is accompanied by the name of that animal; or
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The milk has been subjected to a process or treatment, and the word or description is accompanied by the name of that animal and an indication of that process or treatment; or
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The word or description is used in accordance with any regulations made, or having effect as if made, under the Food Safety Act 1990 or any order having effect as if contained in regulations so made.27
Finally, special provision is made for raw drinking milk, the container in which it is sold must be marked or labelled with the words: “This milk has not been heat-treated and may therefore contain organisms harmful to health”.28
Where raw milk is not prepacked and is sold at a catering establishment there must appear on a label attached to the container in which that milk is sold, or on a notice readily discernible by an intending purchaser the words: “Milk supplied in this establishment has not been heat-treated and may therefore contain organisms harmful to health”.29
No statement is required in relation to raw milk from buffaloes.30
It is an offence31 punishable on summary conviction with a fine not exceeding level 5 on the standard scale for any person to:
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Sell food not marked or labelled in accordance with the 1996 Regulations
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Sell or advertise for sale food in respect of which a claim is made, nutrition labelling is given or a description or a name is used in contravention the 1996 Regulations.
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Sell food from a vending machine in contravention of regulation 29 which makes provision for the display of certain information in particular circumstances on the front of or in close proximity to the vending machine.
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Sell food after the date shown in a 'use by' date relating to it.
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Remove or alter the appropriate durability indication relating to food being a person who is not the manufacturer, the packer, or the seller established within the European Union originally responsible for so marking the food.
2 Regulation (EC) No 1234/2007, Annex I, Part XVI, Milk and Milk Products, CN code 0401
3 SI 2006/14
4 SI 1996/1499
5 Op. cit., Article 114 and Annex XIII, point I(a)
6 Op. cit., Annex XIII, point III(1)(a)
7 Op. cit., Annex XIII, point III(3)
9 Currently £5,000
10 Op. cit., r7
11 Food Safety Act 1990, ss2, 3, 20 and 21
12 Regulation (EC) 853/2004, Annex I, para 4.2
13 Regulation (EC) 854/2004, Annex IV
15 Food Standards Agency, Microbiological Safety of Raw Drinking Milk, Report by Alison Gleadle, Director of Food Safety, 20 March 2012, para 4.13
16 Op. cit., Schedule 6, para 2(1) to (3)
17 Regulation (EC) 853/2004, Annex III, Section IX, Chapters I and II on Raw Milk, Colostrum, Dairy Products and Colostrum-based Products
18 Op. cit., Schedule 6, para 6 and 7
19 Op. cit., Schedule 6, para 1 and r17
21 Ibid., r2(1)
22 See Section 2 above.
23 Op. cit., r5
24Op. cit., r23(2)(a) and (b); see also r26 in its application to indelibly marked glass bottles intended for re-use and r27 in relation to milk sold at catering establishments such as restaurants, pubs, schools, hospitals, etc.
25 Op. cit., r2(1)
26 Op. cit., r37
27 Op. cit., Schedule 8, Part 1
28 Op. cit., r31(1)
29 Op. cit., r31(2)