THE EUROPEAN UNION DIRECTIVES

It is important to clarify some terms before explaining the Directives as they are different from the ones we use in the US.  These are taken from Article 2 of Directive 92/46/EEC:

1.   "raw milk":   milk produced by the secretion of he mammary glands of one or more cows, ewes, goats, or buffaloes, which has not been heated beyond     40 °C (104 °F) or undergone any treatment that has an equivalent effect.

2.   "heat treatment": any treatment involving heating that causes, immediately after it has been applied, a negative reaction to the phosphatase test (which is the definition of  "pasteurization" in the US regulations).

3.   "thermization": the heating of raw milk for at least 15 seconds at a temperature between 57 °C and 68 °C (135 °F and 154 °F) such that after treatment the milk shows a positive reaction to the phosphatase test (which is called "heat treatment" or "sub pasteurization" in the US regulations).

            The deadline for the transposition of this Directive was January 1, 1994,  however, the Council recognized that certain rules were likely to affect both products with traditional characteristics and establishments with limited production.  The Directive allowed member states to apply for changes ("individual and general derogation") to some of the rules by October 1, 1994.  The work on these changes appears to have been complex.  This is probably why the Directive was not fully enforced until January 1, 1998.

              The actual conditions for compliance and measures taken for checking compliance with the rules of the Directive may be amended or supplemented.  In this case, these procedures are "referred to the Standing Veterinary Committee (or "the Committee"), which consults with the Management Committee for Milk and Milk Products, where matters of chemistry or technology are involved."   The changes are to be resolved within a period of three months.  This mechanism is used frequently to determine appropriate steps to take in case of non compliance, including defining the types and frequency of sampling and analysis for investigation.

           

            One very important part of the regulations concerns the situation with the direct sale of raw milk and raw milk products made on the farm.  The EU Council does not regulate this type of operation as long as the farmstead complies with national health rules.  The regulation of the direct-selling producer in France will be discussed later.  It is stated in Chapter I - General Rules: Article 1 that:

            "This Directive does not affect national rules applicable to the direct sale to the consumer by a producer of raw milk obtained from a herd officially free of tuberculosis and officially free or free of brucellosis, or of milk-based products made on his holding with such raw milk, provided the hygiene conditions of the holding comply with the minimum health rules laid down by the competent authority."

  Raw Milk Production and Handling

              The requirements for raw milk used for the manufacture of cheese ("milk-based products or heat-treated drinking milk") in member states is set down in Chapter II - Rules governing Community production: Article 3. 

This article is very important because it refers to many rules and measures that form the risk assessment approach to safe raw milk production and handling.  The main points of Article 3 are as follows:

 

1.      Member Sates shall ensure that raw milk meets the following requirements: 

(a) The milk comes from animals and production holdings which are checked at regular intervals by competent authorities to ensure that animal health and hygiene requirements are being met as follows:

 Þ    regular veterinary inspections of animals on production holdings

Þ    additional inspections if animal requirements are not being met

Þ    regular checks of production holdings to ensure compliance with hygiene requirements

Þ    if the hygiene is inadequate the competent authority shall take appropriate steps to achieve compliance

(b.1)   The milk is checked at the treatment or processing establishment by competent authorities as follows:

 

Þ    hygiene requirements relating to the premises, equipment and staff are met, which include:

·      cross-contamination between operations by equipment, ventilation or staff must be avoided

·      rooms intended for production purposes shall be divided into wet and dry areas, each having its own operating conditions

·      the operator of the establishment shall draw up a cleaning program based on risk analysis to ensure that there is no health risk to products as a result of inadequate cleaning methods

Þ    there is permanent supervision by the permanent or periodic presence of the competent authority

Þ   the competent authority shall take appropriate measures, up to and including suspension of approval, if there is non compliance with the rules of the Directive

  (b.2) The operator or manager of the processing establishment must constantly carry out his own checks to ensure that, at all stages of production, the rules of the Directive are complied with (see article 14, page 13).

   (b.3)  There will examination of the milk for foreign substances including:

  Þ    residues of substances having a pharmacological or hormonal action

Þ        antibiotics, sulfanomides and similar anti-microbial substances

Þ        pesticides, detergents, and other substances which might alter the organoleptic characteristics of the milk or milk-based products and make their consumption dangerous to human health

  (b.4)   Standards to be met for the collection of raw milk from the production holding or for acceptance at treatment or processing establishments (refer to Table 1, page 19).

  (c)    Animal health requirements for raw milk:

  Þ    for cows and buffaloes, officially tuberculosis-free and officially brucellosis-free or brucellosis-free;

      for goats and sheep, officially brucellosis-free or brucellosis-free (Brucellosis melitensis)

Þ    do not show any symptoms of infectious diseases communicable to humans through milk

Þ    in the case of cows, yield at least 2 liters of milk per day

Þ    when different animal species are kept together on the holding, each species must satisfy health conditions which would be required if it were alone.

Þ    if goats are kept with cows they must undergo a tuberculosis check.

Þ    other rules are similar to those in the US, e.g., incapable of giving the milk abnormal organoleptic characteristics.

  (d)    Requirements for hygiene of the holding:

  Þ    rules are similar to those in the US, e.g., premises where milking is performed or milk is stored, handled or cooled must be so situated and constructed as to avoid all risk of contamination of the milk

 (e)    Requirements for hygiene in milking, the collection of raw milk and its transport from the production holding to the collection or standardization center or to the treatment establishment or processing establishment:

  Þ    if the milk is not collected within two hours of milking, it must be cooled to 8 °C (46.4 °F) or lower in the case of daily collection or 6 °C (42.8 °F) or lower if the collection is not daily 

Þ    while milk is being transported to the treatment and/or processing center its temperature must not exceed 10 °C (50 °F)

Þ    absolute cleanliness and healthiness is required of the staff

Þ   other rules are similar to those in the US, e.g.,  a monitoring system shall be established under the supervision of a competent authority to prevent water from being added to raw milk

Milk Processing and Milk-based Products

              The rules for manufacturing raw milk cheeses fall under Article 6 and requirements for the products themselves are contained in Article 7.  In the US, cheese which is called “raw milk cheese” is also made from thermized milk (as defined in the Directive) but this is not the case in the EU as “raw milk cheese” is only made from “raw milk,” which is not heated above 104 °F as defined in the Directive. 

  Under Article 6:

  Þ    The raw milk must comply with the previously stated rules (Article 3)

Þ    raw milk must be used within 36 hours of acceptance, if the milk is kept at 6 °C (42.8 °F) or lower, or within 48 hours of acceptance if the milk is kept at 4 °C (39.2 °F) or lower

Þ        thermized milk must have been obtained from raw milk which, if it is not treated within 36 hours of acceptance, has a standard plate count at 30 °C prior to thermization of 300,000 or less per ml

           Under Article 7, milk-based products must be prepared in processing establishment that meets the Directive standards and specifications.  These rules are similar to those in the US but there are the following exceptions:

  (a)  General conditions of hygiene for premises, equipment and tools:

  Þ        workroom and lavatory taps must not be hand operable

Þ    grandfather clause for wooden walls built before 1 January 1993

  (b) General conditions of staff hygiene

  Þ    staff assigned to the handling of raw materials must be required to wash their hands at least each time work has resumed and/or where contamination has occurred

Þ    clean headgear which completely encloses the hair shall be used

Þ    when recruited, any person handling products shall be required to prove that there is no medical impediment to such employment

  (c)    Standards for milk-based products (refer to Table 2, pages 20 and 21)

  (d)  Conditions governing health marking and labeling:

  Þ    products must carry a health mark (refer to the example on page 22)

Þ    marking must be done during or immediately after manufacture in the establishment, in an easily visible place

Þ    the mark shall be legible and indelible

Þ    the mark may be applied to the product or to the wrapping or, if the product is individually wrapped and packaged, to the packaging

Þ    the health mark must give the following particulars in an oval surround

·      above, the name of the consigning country in capitals

·      in the center, the approval number of the establishment

·      below, one of the following sets of initials: CEE - EOF - EWG - EOK - EEC - EEG

Þ    the health mark may be applied by an ink stamp or by branding or it may be applied to or printed on the label

Þ    products from such establishments that do not bear the health mark cannot be the subject of trade

Þ    the labeling must show ‘made with raw milk’ for milk-based products manufactured from raw milk whose manufacturing process does not include any heat treatment, including thermization

Þ    there shall be a use-by or minimum durability date on labeling for milk-based products in which growth of micro-organisms may occur

  Article 14: The Risk Assessment Plan

              Article 14 is referred in Article 3 (raw milk production) and Article 7 (milk-based products).  The rules define, in simple terms, a risk reduction strategy similar to a HACCP plan.  This adds a mechanism for risk assessment, monitoring, and corrective action of the manufacturing processes in each production facility covered by the Directive.  The inclusion of this section is the most striking difference between the EU and the US dairy regulations.  The rules are as follows:  

  1.    Member States shall ensure that the operator or manager of the processing establishment takes all necessary measures to ensure compliance at all stages of production.

  Þ    To that end, the operator or manager must constantly carry out his own checks based on the following principles:

·   identification of critical points in the processes used in the establishment

·   monitoring and checking of such critical points

·   taking samples for analysis in a laboratory recognized by a competent authority  for the purpose of checking sanitation and compliance with Directive standards

·   keeping a written or registered record of the information required with a view to submitting it to a competent authority for a period of at least two years, except for products which cannot be stored at ambient temperature, the period shall be at least two months after the use-by date

·    inform the competent authority when information reveals that there is a serious health risk

·  in the event of an immediate human health risk, withdraw from the market the quantity of products obtained in technologically similar conditions and likely present the same risk

Þ    the operator or manager must guarantee the correct administration of the health marking

Þ    the competent authority must regularly monitor compliance with identification, monitoring and checking of critical control points

Þ    the operator or manager must organize a staff training program enabling workers to comply with conditions of sanitary production, unless the staff already have adequate qualifications.  The competent authority for the establishment must be involved in the planning and implementation and monitoring of the program

 

Derogation

 

            Member states may be authorized to grant individual or general amendments to the rules for cheese that is made with an aging period of at least 60 days.  These changes pertain to the following  conditions and standards:

Þ        microbiological limits for raw milk may be changed if the finished product meets the requirements for Staphylococcus aureus

Þ        conditions of the processing establishment

Þ    wrapping and packaging

Þ    labeling clearly showing ‘made with raw milk’ is not always required for milk-based products made from raw milk whose manufacturing process does not include any heat treatment, including thermization

Þ    general and particular requirements may be adopted as necessary in accordance with the procedure for making amendments and supplements to the rules of the Directive (Article 31)

 

            Member states may be authorized to make amendments to certain rules if they affect the manufacture of cheeses with traditional characteristics as long as the milk used to make the cheeses meets the animal health requirements for raw milk.  These changes pertain to:

Þ        conditions for milk collection, storage and transportation

Þ    standards for the products

Þ        conditions of the processing establishment

Þ    wrapping and packaging

 

            Member states may also be authorized to make changes to the rules for general conditions for approval of processing establishments manufacturing milk-based products whose production is limited if the establishments are checked by a competent authority and comply with Article 14 (risk assessment and reduction plan).  These limited production establishments can also be exempted from organizing worker training programs for hygienic production.  Uniform criteria for approving these establishments was finalized by January 1, 1998.  Until these establishments were classified, their products could not bear the health mark and could only be marketed at national level.

    

Compliance

 

            The procedures for compliance are laid out in Article 10 and Article 13.  These provisions include registration, inspection and certification as follows:

 

1.  Each Member state shall draw up a list of processing and treatment establishments approved by it.

 

Þ    each such establishment shall have an approval number

Þ    approval by a competent authority shall not be given unless they comply with the rules of the Directive

Þ    this approval may be withdrawn if there is failure to comply

 

2.  Inspection and supervision shall be carried out.

 

Þ    the competent authority from a member state shall make spot checks on production holdings, and processing and treatment establishments to verify that they comply with the rules of the Directive 

Þ    the competent authority must analyze the results of the checks in Article 14

Þ    on the basis of these analyses, conduct further examinations at all stages of production, including microbiological analyses

Þ    the results of the analyses shall be written up into a report, with conclusions and recommendations to the operator of the establishment

Þ    the operator shall rectify the shortcomings noted with a view towards improving hygiene

Þ    in the event of repeated shortcomings, checks shall be increased and, where appropriate, labels or seals bearing the health mark shall be removed

 

            Finally, the EU Commission is given the authority to make checks of establishments to ensure that approved establishments are complying with the Directive.  This is to ensure that the competent authorities are doing their job.

Experts from the Commission may, insofar as is necessary for the uniform application of this Directive and in cooperation with competent authorities, make on-site checks.

 

Þ    they may verify by checking a representative percentage of establishments

Þ    the Commission shall inform the member states of the results of the checks

Þ    a member state in whose territory a check is being carried out shall give all necessary assistance to the experts

 

            An important aspect of Directive 92/46/EEC to note is that its rules do not apply to producers who make dairy products on their small farms and sell them directly to consumers, as long as these producers comply with the minimum health rules laid down by a competent authority in their country. 

The regulations governing all food businesses, including these direct-selling food producers are standardized within the EU and are laid down in Directive 93/43/EEC.

 

 

DIRECTIVE 93/43/EEC [13]

 

            This Directive harmonizes the general rules of hygiene for foodstuffs to be observed at the time of preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling and offering for sale or supply to the consumer in order to protect human health.

            The following terms are defined in the Directive:

1.   ‘hygiene’:   all measures necessary to ensure the safety and wholesomeness of foodstuffs.  The measures shall cover all stages after primary production (the latter including, for example, harvesting, slaughter and milking), during preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling and offering for sale or supply to the consumer.

2.   ‘food business’:    any undertaking, whether for profit or not and whether public or private, carrying out any or all of the following: preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling and offering for sale or supply of foodstuffs.

3.      ‘wholesome food’:    food fit for human consumption as far as hygiene is concerned.

 

            There are four important cornerstones that lay the foundation for this Directive.  These embrace the concepts of HACCP, good hygienic practice, standardization, and education/training. They are as follows:

 

1.   Food business operators shall identify any step in their activities, which is critical to ensuring food safety and ensure that adequate safety procedures are identified, implemented, maintained and reviewed on the basis of the following principles, used to develop the system of HACCP:

     

Þ                analyzing the potential food hazards in a food business operation,

Þ                identifying the points in the operation where the hazards may occur,

Þ                deciding which of the points identified are critical to food safety - the ‘critical points’,

Þ                identifying and implementing effective control and monitoring procedures at those critical points, and

Þ                reviewing the analysis of food hazards, the critical control points and the control and monitoring procedures periodically and whenever food operations change.

     

2.   The preparation, processing, manufacturing, packaging, storing, transportation, distribution, handling and offering for sale or supply 

      of foodstuffs shall be done in a hygienic way.

     

Þ    food business operators shall comply with the rules of hygiene; these are listed in the Annex and are similar to those in the US concerning facilities, personnel, etc..

 

3.      Microbiological criteria and temperature control criteria for certain classes of foodstuffs may be adopted.

     

4.   Member States shall encourage the development of guides to good hygiene practice, which may be used voluntarily by food businesses as a guide to compliance with the rules of hygiene.

     

Þ    by food business sectors and representatives of other interested parties, such as appropriate authorities and consumer groups

Þ    in consultation with interests substantially affected, including the competent authorities

Þ    where appropriate, having regard to the Recommended International Code of Practice, General Principles of Food Hygiene of the Codex Alimentarius

Þ    the guides may be developed under the direction of a national standards institute

Þ                Member States shall forward to the Commission those guides they presume to comply with the rules of hygiene

           

            The Commission recognized that, “there may be a need for guides to good hygiene practice to be developed on a European basis.”  There are provisions in the Directive for creating “European guides to good hygiene practice” with the intention of harmonizing procedures throughout the EU.

 

            The mechanisms for making amendments to this Directive are similar to those in Directive 92/46/EEC, which is also the case for ensuring compliance with the rules. 

 

           

 

 

            If the competent authorities find a case of failure to comply, where it might result in risks to the safety or wholesomeness of foodstuffs, they shall take appropriate measures as follows:

 

Þ        withdrawal and/or destruction of the foodstuff

Þ    closure of all or part of the business for an appropriate period of time

Þ    and determine the risk to food safety or wholesomeness, with regard to the nature of the food, the manner in which it is handled and packed, and any process to which the food is subjected before supply to the consumer and the conditions under which it is displayed and/or stored

 

            Any person affected by the control has the right to appeal the measures taken by the competent authority.

 

            After adoption of Directive 93/43/EEC, member states were given 30 months to bring the rules into force.  It is clear from this review of the Directives that all food producers and sellers in the EU are required to have some form of a risk assessment and reduction plan in place at their establishment, based on HACCP principles or otherwise.  This risk reduction plan, combined with rules for stricter microbiological standards for raw milk used in raw milk cheese production and raw milk cheese, characterizes the approach taken by the EU to assure the safety of raw milk cheese.  There is flexibility built into the Directives for addressing the manner in which “milk-based products with traditional characteristics” and limited-production establishments are regulated.  The member states were instructed to start the process of granting derogation in order that they identify dairy products, whose character would be affected by the rules of the Directive.  This allowed authorities to review milk collection, storage, manufacturing, and packaging methods and find agreeable ways to maintain tradition. 

Table 1.  Standards for raw milk intended for the manufacture of milk-based products (maximum limits per ml of milk) from Directive 92/46/EEC.

	Cow  milk		Sheep and Goat milk		Buffalo milk
	for products made with ‘heat-treated milk’	for products ‘made with raw milk’	for products made with ‘heat-treated milk’	for products ‘made with raw milk’	for products made with ‘heat-treated milk’	for products ‘made with raw milk’
Date of enforcement	1.1.98	1.1.98	1.1.94	1.1.94	1.1.94	1.1.94
Standard plate count (a)	100,000	100,000	1,000,000	500,000	1,000,000	500,000
Somatic cell count (b)	400,000	400,000			500,000	400,000
Staphylococcus aureus  (1) n=5, c=2 m   M		500   2,000		500   2,000		500   2,000

 

(a)  Geometric average over a period of two months, with at least two samples per month

  (b) Geometric average over a period of three months, with at least one sample per month, or

        where production levels vary considerable according to season, method of calculating results 

        can be adjusted in accordance with procedures for amending the Directive

 

(1)  Where:

      n =  number of units comprising the sample;

      m = threshold value for the number of bacteria; the result is considered satisfactory if the number of bacteria in all sample units does not exceed ‘m’;

      M =  maximum value for the number of bacteria; the result is unsatisfactory if the number of  bacteria in one or more sample units is ‘M’, or more;

      c =    number of sample units where the bacteria count may be between ‘m’ and ‘M’, the sample  considered acceptable if the bacteria count of the other sample units is ‘m’ or less.

Table 2:  Microbiological criteria for certain milk-based products on removal from the processing establishment from Directive 92/46/EEC.

¨   Table 2a:  Pathogenic micro-organisms

Type of micro-organism	Hard cheeses	Other cheeses
Listeria monocytogenes	Absence in 1 g n=5, c=0	Absence in 25 g (a) n=5, c=0
Salmonella spp	Absence in 25 g, n=5, c=0
In addition, pathogenic micro-organisms and their toxins must not be present in quantities such as to affect the health of consumers

 (a)  the 25 g sample consists of 5 specimens of 5 g taken from different parts of the same product

 

¨   Table 2b: Indicator organisms: guidelines

	Soft cheeses made from heat-treated (pasteurized) milk
Coliforms (plate count at 30 °C) per g	m = 10,000 M = 100,000 n = 5, c = 2

¨   Table 2c:  Micro-organisms indicating poor hygiene

Type of micro-organism	Cheeses made from raw milk and from thermized milk	Soft cheese made from heat-treated (pasteurized) milk	Fresh cheeses made from heat-treated (pasteurized) milk
Staphylococcus aureus per g	m = 1 000 M = 10,000 n = 5, c = 2	m = 100 M = 1,000 n = 5, c = 2	m = 10 M = 100 n = 5, c = 2
Escherichia coli per g	m = 10,000 M = 100,000 n = 5, c = 2	m = 100 M = 1,000 n = 5, c = 2

 

In all cases where these standards are exceeded there must be a review of the implementation of the methods of monitoring and checking critical control points applied in the processing establishment pursuant to Article 14 of Directive 92/46/EEC.  The competent authority shall be informed of the corrective procedures included in the production monitoring system to prevent any repetition of the occurrence.

In addition, whenever the standard M is exceeded in the case of cheese made from raw milk and from thermized milk or soft cheese, testing must be carried out for the possible presence of toxins in such products.

If strains of enterotoxinogenic Staphylococcus aureus or strains of Escherichia coli that are presumed to be pathogenic are identified, all the batches involved shall be withdrawn from the market.  In this case the competent authority shall be informed of the findings and of the action taken to withdraw the suspect batches and the corrective procedures introduced into the production monitoring system.