“Maisto saugos vadybos sistema”

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Dry cured ham

Food Safety Management system in ParmaHam Production

Fiorucci Food, Italy

Exam project in International Food Legislation and Quality Management (270064)

Department of Food Science

Faculty of Life Sciences

University of Copenhagen

Line Christensen FSK06023

Stine Elise Dedenroth FSK07033

Anne-Marie Jensen Kerstens FSK05020

Preface

The present exam project is composed in Block 1 2007 as a part of the course International food legislation and quality management (270064) at department of Food Science, Faculty of Life Sciences, University of Copenhagen.

International food legislation and quality management is a part of the specializations Dairy technology and Meat science annd technology, and it gives applied science competences within international food legislation and quality management systems throughout the food chain.

The course objective was to obtain knowledge about international quality management systems in the agri-food chain and understanding of the concepts of food quality and design of food products. Further the objective of the course was to obtain detailed insights in food safety management and to obtain knowledge of international food legislation (EU).

Regarding the supervision of the exam project we woould like to thanks lector Niels Arneborg, Department of Food Science/Food Microbiology.

Copenhagen 26. October 2007

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Line Christensen Stine Elise Dedenroth Anne-Marie Jensen Kerstens

FSK06023 FSK07033 FSK05020

Abstract

This report was based on the production of Parma Ham, produced the traditional Italian way, by Fiorucci Food. The p

production of Parma Ham was described and illustrated in a flow sheet. In relation to production of Parma Ham, the relevant requirements in EU food law were outlined.

Based on the requirements in ISO22000:2005 a table of content for a Quality Manual, procedures and instructions were fabricated. Besides the requirements in ISO22000:2005 two additional chapters, purchasing and personnel hygiene, were added to the quality manual.

Based on the production of Parma Ham, biological, physical and chemical hazards were considered. In each category one hazard were chosen: Salmonella, Glass and Cleaning agents, and a proposal for an oPRP and/or a HACCP plan were developed for each hazard. Only one Critical Control Point was found in this production; the salting of the hhams, since this step eliminates Salmonella.

Project description

Group project 2: Dry cured ham – Fioruccifood, Italy

For information about the Company and its range of products the homepage www.fioruccifood are consulted. Among the wide range of products manufactured by Fiorucci Food the present project is limited to dry cured ham produced in the traditional Italian way (Parma ham).

Based upon information collected on production of traditional Italian dry cured ham a description of production from raw materials to the final product are given. Furth

her relevant food safety hazards are identified and described. Based on the requirements given in “ISO22000:2005” an outline of a food quality management system is made. The outline illustrates the overall structure of the system by tables of contents for the Quality Manual, Procedures and Instructions. A proposal for an operational prerequisite program and a HACCP-plan is presented.

The basic requirements laid down in the EU regulations valid for Parma Ham are outlined including links to the food quality management system established.

Table of content

Introduction to Fiorucci Food

Fiorucci Food is an Italian producer of cured meats for four generations, starting from an artisan workshop turning into an international foodstuff group, who are maintaining a high level of food quality. Fiorucci Food has 6 factories; 5 situated in Italy and 1 in USA. All the production plants are certified by ISO 9001:2000 and ISO 14001. The part of the organisation of Fiorucci Food, which is of relevance to this project report, is illustrated in Figure 1.

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Figure 1. Organisation diagram of Fioruccifood (modified from www.fioruccifood.it,18. October 2007). Organisation diagram for the production plant, Felino, is illustrated. * illustrates members of the HACCP-team.

The six factories are organised under the department of Procurements and Operations, and each factory has its own organisation structure, as the structure illustr

rated for the factory Felino (Figure 1).

The headquarter of the Gruppo Alimentare Cesare Fiorucci, S. Palomba, is situated in the Roman countryside, in Santa Palomba. S. Palomba has a yearly Production Capacity of Italian deli meat of 60.000 tonnes.

In the province of Parma two cured ham factories, Langhirano and Felino, are producing Protected Designation of Origin (PDO), Parma ham and sliced cured ham. The PDO designation is protected by the consortium of Parma Ham (www.prosciuttodiparma.it). Langhirano are producing the sliced Parma Prosciutto (800 tonnes a year). Felino are the producer of Parma Prosciutto and foreign cured hams, production capacity of 330,000 raw hams. It is described in the Project description (page iv) that the project is limited to a dry cured ham produced the traditional Italian way as the production of ham at the factory Felino. Therefore Felino is highlighted in the organisation diagram (Figure 1) and the organisation of Felino is illustrated. Further, the * mark illustrates the members of the HACCP team at Felino (see section 5; ad. i).

Another curing factory is the S. Daniele Del Friuli (Udine) owned by Nuova Mondial SpA. S. Daniele Del Friuli has a production of San Daniele Prosciutto with a yearly capacity of 150,000 dry cured hams whereas 75,000 are produced for Fiorucc

ci. The factory belongs to the San Daniele protection consortium (www.prosciuttosandaniele.it), where the San Daniele PDO dry cured ham is produced.

In Castelnuovo Rangone in the province of Modena a vinegar factory, Castelnuovo Rangone, is situated. In the vinegar factory the production and ageing of the Modena Balsamic Vinegar takes place. The annual production capacity is 2,600 tons.

The last production plant is situated in Richmond (Virginia) in the USA, where the production and marketing of the Fiorucci speciality foodstuffs (salamis, mortadella, cured and cooked hams) for the North American markets occur. The annual production capacity is 16,000 tons.

Fiorucci Food sells their products to 49 countries all over the world; examples are Hungary, Poland, Spain, Argentina, Japan, Hong Kong and Denmark. Due to the large export branches, direct offices are situated in France, Germany, England, Spain and USA. Selling to different member states within EU, European legislation applies, while exporting to countries outside EU national import legislation applies (see section 3.1). For instance when exporting dry cured hams to USA the rules by FSIS/USDA have to be fulfilled.

Fiorucci Food’s products are the result of a manufacturing process, respecting the Italian traditions. This is the reason why FiorucciFood’s product qualityis protected by the Consortiums which guarantee the quality connected to the PDO and Protected Geographical Indication (PGI). Among the wide range of products manufactured this project report is limited to a dry cured ham produced the traditional Italian way, Prosciutto di Parma (see Project description, page iv).

(All the above information about Fiorucci Food is found on the webpage www.fioruccifood.it)

Production of dry cured ham

This section gives an overview of the production of dry cured ham.

Flow sheet

The flow sheet of the production of dry cured ham is illustrated in Figure 2.

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Description of flow sheet

Receiving and inspection of raw materials

In this step an inspection of the raw materials (hams and salt) is carried out. Raw materials used for production of dry cured ham must follow the requirements outlined in the instruction on characteristics of raw materials (I.9.3.3.1, section 6.3). The Instruction describes that the supplier of the hams used for the Parma ham production must fulfil several obligations. The hams must come from pigs, which had a slaughter weight of at least 140 kg and the pigs utilized for production of Parma ham must come from northern and central Italy (Feiner, 2006). Further, the feeding of pigs to be processed for Parma ham is commonly tightly controlled, since the feed has an impact on the fatty acids composition present in the pig fat, which in turn has a significant impact on flavour development caused by lipases during the long period of drying. (Feiner, 2006). The supplier also makes sure that the hams have a weight of minimum 9 kg and maximum 13 kg (Feiner, 2006). Instruction 9.3.3.1 also describes that the ham has to carry a visible tattoo, brand and seals (according to traceability, Procedure 9.9) on its skin. These marks are shown in Figure 3.

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Figure 3. A: tatoo indicating birth place, breeders code and the month of birth; B: brand identifying the slaughterhouse; C: metal seal indicating the date at which the curing process began (www.prosciuttodiparma.com).

Within 30 days of birth an indelible tattoo (Figure 3A) is placed on both rear hams of the young pig indicating birth place, the breeder’s code and the month of birth. The authorized abattoirs apply a firebranded code on the pigskin of each fresh trimmed ham permanently identifying the slaughterhouse (Figure 3B). A metal seal is attached to each ham during the salting stage, bearing the Consortium’s initials (CPP) and the date at which processing began (Figure 3C).

At the inspection of the raw materials at Fiorucci Food, the hams are visually inspected in batches. Fiorucci Food divides the production into batches since, if one ham in a batch is unsafe, the rest of the batch is also considered unsafe unless a detailed assessment shows that it is not (see section 3.1). The control measures at the inspection are done according to the oPRP plan (Table 8). The temperature requirement (< 5°C) is lower than the legal requirement (<7ºC) (see section 3.3). The 5ºC is selected to prevent growth of Salmonella (section 4.1).

Chilling of raw materials to 0°C

The inspected raw hams are chilled to around 0°C for 1-2 days before being salted.

Application of salt

Prior to salting, the hams are weighed and massaged to remove the last traces of blood. Minimum 25 g of salt per kg of meat are applied by hand, following a standardised procedure for at least 4 minutes. After addition of salt the hams are weighed again to control the amount of salt added.

Drying – stage1

The salted ham is placed on racks at temperatures of 1-4°C for around 1 month and some additional salt is applied around 7-10 days after the first salting took place. During this month, the brine developed as a result of salting, runs off.

Washing with lukewarm water

After salting for around 1 month excess salt is removed by washing the hams with lukewarm water.

Drying – stage 2

The washed hams are stored in a dry room for 1-2 days at around 70-74% relative humidity (RH) to dry the surface quickly again. Quite a low level of salt is applied overall.

Drying – stage 3

After a month, the distribution of salt in the ham is equalized by hanging up the hams at a room temperature of 3-5°C for around 2 months (Feiner, 2006).

Weighing

To control the weight loss the hams are weighed after the first 3 months of drying. The weight loss during this period of around 3 months is between 12% and 15% as the RH applied during this period is between 75% and 85%.

Flavour development

Following the 3 months of salting and drying, the product is then commonly placed 4-6 days at 20-22°C to start the enzyme activity for flavour development (Feiner, 2006).

Drying – stage 4

The next 3-8 months of drying occurs at 14-16°C and 70-74% RH in conditions with some degree of air circulation. Factories are built at 90° angle to a river, which keeps the level of moisture constant as well as causing some air circulation (Feiner, 2006). The drying rooms are equipped with large windows that are opened when the outside temperature is favourable. Producers of Parma ham believe that this period is critical to the development of the distinctive flavour of Parma ham (www.prosciuttodeparma.com).

Weighing

The hams are weighed again to further be able to control the weight loss. After around 7 months from the first day of salting, the ham has lost around 22-25% (Feiner, 2006) in weight and the surface of the ham is dry and hardened (www.prosciuttodeparma.com).

Hams are covered with fat

The hams are covered with a mixture of flare fat, pepper, rosemary (to avoid rancidity) and some salt. To allow the ham to breath, a small area next to the bone on the topside is not covered.

Drying – stage 5

The ham is then dried at 14-16°C and RH at 70-74% for another 3-5 months, but only another 5% of weight is lost due to the coverage of the exposed surface. During these 3-5 months, development of flavour takes place as a result of proteolysis and lipolysis that form peptides and free amino acids as well as free fatty acids. Tenderization of muscle tissue also takes place in this period because collagenase activity loosens up the structure of intramuscular collagen.

Quality inspection

After around 12-14 months the hams are ready for sale, although some producers dry their hams as long as 30 months (www.prosciuttodeparma.com). The ham has now lost around 30% of its initial weight. Quality inspection of the ham is carried out by sticking a horse bone several times into the knuckle and upper area of the ham, thus checking the flavour obtained on the bone. Specialized people perform this smell test to detect whether the ham is ready for sale or not. For each batch test sampling is done to validate the microbiological quality.

At the end of the quality inspection a five point Ducal Crown brand is added along with the identification code of the producer, and is the final guarantee of the quality of the ham. The five point Ducal Crown is shown in Figure 4 (www.prosciuttodiparma.com).

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Figure 4. The five point Ducal Crown with identification code of the producer (www.prosciuttodiparma.com).

Packaging

Whole bone-in hams are vacuum packed.

Distribution

Hams are distributed to costumers at 4-8°C.

Legislation

In the EU legislation several regulations and directives has relevance for the production of Parma Ham. These regulations and directives cover different areas hygiene, labelling and protection of local products. These regulations and directives are mentioned in Table 1. Besides the regulations in Table 1, there are also legislation covering environmental issues, work environment and other areas.

Table 1. Overview of some EU regulations and directives concerning the production of dry ham.

Subject

Regulation/directive

Title

General food law

178/2002

Laying down the general principles and requirement of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

Hygiene

852/2004

On the hygiene of foodstuffs

853/2004

Laying down specific hygiene rules for food of animal origin

Official control

854/2004

Laying down specific rules for the organization of official controls on products of animal origin intended for human consumption

882/2004

On official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

Microbiology in foods

2073/2005

On microbiological criteria for foodstuffs

Labelling

2000/13

On the approximation of the laws of the Member States relating to the labelling, presentation and

advertising of foodstuffs

Protection of local products

510/2006

On the protection of geographical indications and designations of origin for agricultural products and foodstuffs

Thissectionfocuses on the laws concerning food law. For each of the regulations the section will point out the articles and paragraphs relevant for production of Parma ham, and where there are links to ISO22000:2005 these will be pointed out.

The part about labelling is a directive, which means that it does not apply directly to dry cured ham producer, but should be incorporated into the laws in the member states. In this case it is assumed that the directive has been incorporated in Italian laws. For the dry cured ham producer it is important to know that Directive No. 2000/13 states that the labelling and advertising should not be misleading (article 2). The producer should also label the ham with the following information: name of the product, ingredients (in order of weight (article 5)), “use by date”, storage conditions, name and address of the manufacturer, place of origin (article 3) and net weight (article 8). These rules do not apply for product exported outside EU (article 23). Directive No. 2000/13 article 3, 5 and 8 can be linked to ISO22000:2005 (chapter 7.3.3.2).

On Fiorucci Foods homepage, it says that Parma Ham is a PDO product (Protection of Designations of Origin). Being granted a PDO- mark means that it is only legal to produce Parma Ham in certain areas, and according to certain specifications. The mark can be granted to products according to Regulation No. 510/2006; On the protection of geographical indications and designations of origin for agricultural products and foodstuffs. When the product has become protected according to Regulation No. 510/2006, it can be stated on the product with a special mark.

Regulation No. 178/2002

Laying down the general principles and requirement of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

Regulation No. 178/2002 (Reg. No. 178/2002), lay down the general principles for food law. It is important for the ham producer to know this regulation, since it defines some of the terms used in the other regulations. Article 2 and 3 defines food, but also other terms necessary, for instance the term hazard. In article 4 it is defined that this law cover all stages of production, processing and distribution of foods. This is important for the ham producer since the hygiene package (Reg. No. 852/2004, Reg. No. 853/2004, Reg. No. 854/2004), uses these definitions.

Export of dry cured ham to countries outside the EU is described in article 12. It states that a product exported from the EU has to fulfil the same standard, as if it was to be sold on the community market. There are two exceptions, the authorities in the receiving country require otherwise, or there is a bilateral agreement between the EU and the receiving country. The requirements to be fulfilled for a product to be placed on the EU market are covered in article 14. In this article there are several paragraphs of interest to the ham producer. In §1 it states that a product should not be placed on the market if it is considered unsafe. When determining whether a dry cured ham is safe or fit for human consumption, the normal use of the product should be considered (§3 and §5). In this case the consumer will eat the dry cured ham untreated. The dry cured hams may not be injurious to health on long term, for the next generation, or have any cumulative effects (§4). The producer has to divide his production into some kind of batch or lot, as stated in §6, that if one product in a batch is considered unsafe, the rest of the batch is also unsafe, unless a detailed assessment shows that it is not.

When the producer is planning his advertisement and labelling of the product article 16 has to be taken in consideration, article 16 states that the presentation of the product shall not mislead the consumer in any way. This area is also covered by Directive No. 2000/13.

The producer has to be aware that it is his responsibility that the product satisfy the requirements of the law, that is relevant for his activities, according to article 17 §1. It is also the producer’s responsibility that if there are any suspicion that the product is not in compliance with food safety requirements, to initiate a withdrawal of the food and to inform the competent authorities. If the product has reached the customers the producers is responsible to inform them, and if it is necessary to recall the product. All of this has to be done according to article19 §1 and §3. The producer is also obligated to collaborate with the authorities on the actions taken due to a noncompliance, article 19 §4.

When producing foodstuffs the producer has, according to article 18, to make sure he has a proper traceability program. A traceability program has to be incorporated in all stages of production. The producer has to be able to identify all suppliers and develop a system that makes it possible to keep document of the traceability and to make the documents available for the authorities (§1 and §2). In the same manner the producer has to be able to identify other business operators to which there product has been supplied (§3). The producer also has to make sure that the product is labelled in a way that makes it possible to identify it (§4). A linking to ISO22000:2005 is made in Table 2.Table 2. Comparison between Regulation No. 178/2002 and ISO22000:2005

References in text

Regulation No. 178/2002

ISO22000:2005

Article 1

Chapter

Scope

All stages of production, processing and distribution.

Art. 1 §3

It is applicable to all organizations involved in any aspect of the food chain.

Article 3

Hazard

Biological, chemical or physical agent with potential to cause adverse health effect.

Art.3 §14

3.3

Food safety hazard.

Article 4

Scope

All stages of production, processing and distribution.

Art. 4 §1

It is applicable to all organizations involved in any aspect of the food chain.

Article 14

FoodSafety requirements

Food shall not be placed on the market if it is unsafe.

Art. 14 §1

All

The standard is made to ensure food safety.

Article 17

Responsibilities

Verify that requirements of food law is meet.

Art.17 §1

1 (b)

The organization shall comply with food safety requirements.

Article 18

Traceability

Traceability of food shall be established at all stages of production, processing and distribution.

Art. 18 §1

7.9

They organization shall establish a traceability system that enables the identification of product lots and their relation to batches of raw materials, processing and delivery records.

Suppliers

Operators should be able to identify suppliers.

Art. 18 §2

7.9

The traceability system shall be able to identify incoming material from the immediate suppliers.

Distribution route

Systems and procedures to identify the other businesses to which their products has been supplied .

Art. 18 §3

7.9

The traceability system shall be able to identify they initial distribution route of the end product.

Article 19

Withdrawals

If a product is considered not to be in compliance with the food safety requirements, the food business operator shall immediately initiate procedures to withdraw the food in question from the market.

Art. 19 §1

7.10.4

The organization shall establish and maintain a documented procedure to enable and facilitate the complete and timely withdrawal of lots of end products which has been identified as unsafe.

Information to the authorities

The operator shall inform the competent authorities if it considers as an unsafe product has reached the market. And inform the authorities about actions taken to prevent risk to the final consumer

Art. 19 §3

7.10.4

The organization shall establish and maintain a documented procedure for notification to relevant interested parties.

RegulationNo.852/2004

On the hygiene of foodstuffs

Regulation No. 852/2004 is the regulation laying down the ground rules for hygiene demands during food production. For the producer of dry ham it is necessary to know this regulation, but also to remember that it has to be supplemented by Regulation No. 853/2004 laying down specific hygiene rules for food of animal origin. The regulation emphasize some of the topics as in Regulation No. 178/2002, for instance that the producer is the primary responsible for food safety (Reg. No. 852/2004, article 1 §1).

For the production of dry cured ham several articles are important. Article 1 §1 requires implementation procedures based on HACCP principles and good manufacturing principles. The producer also has to ensure that the microbiological criteria’s and temperature demands are based on a scientific risk assessment.

To gain the right understanding of the regulation, the producer also has to read article 2; definitions, in addition to these definitions the producer also has to read the definitions given in regulation 178/2002 article 2 and 3.

The producer of dry ham has to make sure that the processes under his control, fulfil all the relevant requirements in this regulation (article 3). The producer will have to read article 4 to realise which rules apply for his production. In this case the production fits the definition in article 4 §2, the production has to follow the regulations in annex II and Regulation No. 853/2004. The producer also has to implement some of the specific hygiene measures mentioned in article 4 §3: a, b, c and e.

Guides provided for article 7, 8 and 9 may be used as a way to reach the obligations under Regulation No. 852/2004 (article 6), it means that the producer can use national and community guides as a help on a voluntary basis.

The producer is obligated to make a HACCP-program according to article 5, to review it and if necessary change the program if the process is changed in any way. It has to be documented that a HACCP program is implemented, in a way that satisfy the competent authorities, and to keep these documents updated and kept for an appropriate time scale (article 5 §4). The producer of dry cured ham is also obligated to cooperate with the competent authorities in accordance with other community and national laws (article 6 §1). In this case the producer has to cooperate under Regulation No. 853/2004, and national laws. The producer is obligated to inform authorities of all establishments that is carrying out the production (article 6 §2).

Article 11 states the foods for export has to fulfil the requirements in article 3 to 6 in this regulation, but also article 12 in Regulation No. 178/2002.

Regulation No. 852/2004 annex II

The dry cured ham producer has to make sure that the requirements for the factory premises are met, these requirements are mentioned in annex II chapter I. Most of requirements are non-specific, and give a possibility for interpretation. For instance the producer has to decide how many wash basins are adequate. Besides the requirement of the factory premises, there are specific requirements for rooms where the food are prepared and treated (chapter II), and for the equipment that is used (chapter V). All of these things are to be kept in a good condition to avoid contamination, and should be easy to clean. The dry cured ham producer would have to check that his factory and all off the equipment fulfil this. But for the producer of dry cured hams especially chapter 1 point 5 and chapter 2 point 1 (d) is important. These states that ventilation systems are to be constructed in a manner to avoid contamination. In this case windows are used to ventilate the drying areas (see section 2.2), so the producer has to ensure that there is some kind of filter avoiding contamination through the open windows. The conveyances used have to be well maintained and clean, and everything placed in them should be protected from contamination. If the same conveyance is used for both unprocessed and processed product there should be an effective separation (chapter IV).

Waste from the production is to be removed in a proper manner following chapter VI. The water used is potable and there must be all the potable water needed. Non-potable water is kept away from the potable water (chapter VII).

For the dry cured ham producer it is essential that his employees follow the hygienic rules in chapter VIII, and that none of his employees carry a disease that can contaminate the product. It is alsovery important that the employees are trained, so they are aware of the food safety role that they possess (chapter XII). The dry cured ham producer has to make sure that the raw materials received are safe; if it in any way can be expected to be unsafe it has to be rejected. During storage and production the product shall be protected against all kinds of contamination including that from pest and domestic animals and kept at the right temperature at all times (chapter IX). Before sending of the dry cured ham the producer has to make sure that the wrapping in no way is to contaminate the product (chapter X). A linking to ISO22000:2005 is made in Table 3.

Table 3. Comparision between Regulation No. 852/2004 and ISO22000:2005

References in text

Regulation No. 852/2004

ISO22000:2005

Article 1

Chapter

Implementation of HACCP-principles

Implementation of procedures based on HACCP principles.

Art. 1 §1 (d)

7.1

The organisation shall plan and develop processes needed for a safe product, including oPRPs, PRPs and CCPs.

Article 3

Obligations

The food business operator has to ensure that the hygiene requirements in the regulation are meet.

Art. 3

5.2 b

The management has to conform with statutory and regulatory requirement.

Article 4

Sampling and analysis

Sampling and analysis.

Art. 4 §3 (e)

8.2

Validation of control measure combinations.

8.4.2

Verification results.

Article 5

HACCP-plan

The food business shall implement a HACCP-plan.

Art. 5 §1 and §2

7.6

Establishing the HACCP-plan.

Documents

All documents should be developed, updated and retained for an appropriate period.

Art. 5 §4 (b) and (c)

7.3.1

All relevant information shall be maintained.

Cooperation

The food business shall cooperate with the competent authorities.

Art. 6 §1

5.6.1 (c)

The company shall communicate with authorities.

Annex II

Food premises

General requirements for food premises.

Annex II Chapter Ι and Chapter II

7.2

Prerequisite programmes.

Equipment

Equipment requirements.

Annex II Chapter V

7.2

Prerequisite programmes.

Waste

Food waste.

Annex II

Chapter VI

7.2.3 (d) and (f)

Waste and sewage disposal.

Water

Water supply.

Annex II

Chapter VII

7.2.3 (c) and (f)

Supply of air, water, ice and steam.

Personal hygiene

Personal hygiene.

Annex II

Chapter VIII

7.2.3 (j)

Personal hygiene.

Pest control

Procedures to control pests.

Annex II

Chapter IX, 4

7.2.3.(i)

Pest control.

Storage conditions

Raw materials and ingredients are not to be kept at temperatures that might result in a risk to health.

Annex II

Chapter IX, 5

7.3.3.1 (f)

Storage conditions and shelf life.

Training

Training.

Annex II

Chapter XII

6.2.2 (b), (c) and (e)

Competence, awareness and training.

RegulationNo.853/2004

Laying down specific hygiene rules for food of animal origin

This regulation supplement Regulation No. 852/2004 on food hygiene. Regulation No. 853/2004 applies to all unprocessed and processed products of animal origin and is therefore of interest in production of dry cured ham. To use this law it is necessary to read and understand the definitions in article 2, it states that it follows the definitions from Regulation No. 178/2002 and 852/2004, and the ones given in annex I. A dry cured ham fits in the definition for a “meat product”, since the cut surface no longer has the characteristics of fresh meat.

Regulation No. 853/2004 also states that the producer is only allowed to place the product on the market if it meets the requirements in Regulation No. 852/2004 and in annexes II and III of Regulation No. 853/2004. The requirement for Regulation No. 852/2004 concerning a dry cured ham produced has been shown previously. In annex II point 1 it is stated that identity marks have to be placed on the product. The mark placed on the product must be legible and indelible; it must indicate the name of the originating country and the approval number for the establishment (annex II point 5 and point 6). The mark must be placed so it is clearly displayed for the competent authorities (annex II point 5). The mark may be applied to the dry cured hams in different manners, but for all of them go that it has to be irremovable (annex II point 9). If the producer chooses to apply the mark directly to the ham, he has to ensure that the colour is approved under community rules (annex II point 14). Annex II point 4 is also emphasizing that the producer has to have traceability in place, as stated in Regulation No. 178/2002. Receiving raw materials it is important that it is stored below 7 ºC. The product may not be exposed to contamination during transportation (annex II chapter 7).

It is important for the producer of the dry cured hams to know that he is obligated to cooperate with the competent authorities according to Regulation No. 854/2004 (Reg. No. 853/2004). He is also obligated to ensure that when it is required, all necessary paperwork follow the products (article 7 §1).

Since this regulation supplement Regulation No. 852/2004, no new links to ISO22000:2005 has been found.

Regulation No. 854/2004 and Regulation No.882/2004

Both of these regulations are regulations that lay down rules concerning the official control of compliance with food law. The producer of dry cured ham, has to offer all the needed assistance to the competent authorities. The producer has to give the competent authorities access to all premises and to give access to all documentation and records needed for the competent authorities to judge a given situation (Reg. No. 854/2004, article 4 §1). In this regulation the competent authority means, the authority of a member state competent to carry out veterinary checks. If an inspection is carried out on the premises the dry cured ham producer are obligated to assist the competent authorities so they are able to do their work (Reg. No. 882/2004, article 4 §2 (g)).

Regulation No. 2073/2004

On microbiological criteria for foodstuffs

This regulation lays down criteria’s for certain microorganisms in food stuff. A food mentioned in annex I has to live up to criteria that is made in the annex (article 3 §1). In general a food business manufacturer who is responsible for a product should perform studies as stated in annex II (article3 §2). The studies should include a description of the product, which should include all properties of importance for microbiological growth, for instance pH, aw etc. The producer should also look into the available scientific literature. If necessary, additional studies should be made, these studies should take into consideration the variability in the product, the microflora of the product, and the processing and storage conditions (annex II).

The producer of dry cured ham, do not have to take into consideration annex I, since the product does not fall into any of the categories mentioned. But the producer should make the studies required in annex II.

Food safety hazards in dry cured hams

Food safety hazards are defined as harmful substances present in food. Any substance that is reasonably likely to cause harm, injury or illness, when present above an established acceptable level, is a food safety hazard (Alli, 2004). There are three recognized categories of food safety hazards: biological hazards, chemical hazards, and physical hazards. The origin of these hazards can be from naturally occurring substances or agents in foods, from deterioration or decomposition of foods, or from contamination of the food with the hazard at various stages of the production, harvesting, storing, processing, distribution, preparation and utilization (Alli, 2004). The three categories are described in detail below.

Biological hazards in dry cured hams

Biological hazards cover food-borne pathogenic bacteria, vira and parasites. Food-borne pathogenic bacteria are responsible for a large proportion of food poisoning incidents all over the world, which emphasize the importance of this group of hazards (Adams & Moss, 2000; Alli, 2004). The foods commonly involved in these food poisonings incidents include meat and poultry and their products, seafood and seafood products, egg and egg products, milk and dairy products, fruit and vegetables and their products, low-acid canned foods and water (Alli, 2004).

Bacteria such as Salmonella spp. and Staphylococcus aureus are the major pathogens in the production of air-dried products (Feiner, 2006). Salmonella spp. are primarily inhabitants of the gastrointestinal tract, and are carried by a wide range of wild animals, birds, pets etc. Food animals may acquire Salmonella infection on the farm from wild bird and rodents, but the principal sources are other animals and contaminated feeding stuffs. Transfer of Salmonella between animals is particularly associated with situations where animals are stressed and crowded, such as during transport and when in lairage at the slaughterhouse (Lawrie, 2006). Salmonella spp. are facultative anaerobic, and grow from 5°C (Adams & Moss, 2000). The minimum water activity (aw) for growth is around 0.93, but the cells survive well in dried foods (Adams & Moss, 2000). Most Salmonella spp. are regarded as human pathogens, though they differ in the characteristics and severity of the illness they cause. Salmonellosis is described as a zoonotic infection since the major source of human illness is infected animals (Adams & Moss, 2000).

Staphylococcus aureus (Staph. aureus) is facultative anaerobic, and grows at temperatures above 7°C. Staph. aureus produces enterotoxin at higher temperatures (35-40°C). Staph. aureus is very tolerant of salt and reduced aw (>0.83). Production of enterotoxin occurs down to an aw of around of 0.86 (Adams & Moss, 2000). Staph. aureus occurs most frequently on the skin, and is a part of the skin microflora. Though not in itself a health threat, the presence of Staph. aureus on raw meats does pose a risk of cross-contamination of processed food. Especially salted meats (e.g. ham) are vulnerable to cross-contamination at food handlers, since Staph. aureus is unaffected by levels of salt that will inhibit a large proportion of the competitive flora (Adams & Moss, 2000).

Is risk of E. coli also exist in dry cured ham. E. coli is an almost universal inhabitant of the gut of humans and animals where it is the predominant facultative anaerobe, though only a minor component of the total microflora. Its common occurrence in faeces, ready culturability, generally non-pathogenic character, and survival in water led to the adoption of E.Coli as an indicator of faecal contamination and the possible presence of pathogens such as Salmonella spp. Some strains of E.Coli, e.g. O157:H7, can cause foodborne illnesses such as heamorrhagic colitis. Faecal contamination of water supplies and food handlers contaminating the product are frequent causes for outbreak of diarrhea, while mainly undercooked ground meat has been involved in outbreaks caused by O147:H7 (Adams & Moss, 2000). Temperature optimum for E.Coli is 37°C, although it grows from 7°C up to 50°C. The minimum aw for growth is 0.95. The failures that lead to outbreaks of E.Coli are normally simple breakdowns of basic food hygiene (Adams & Moss, 2000).

Entry of pests (rodents, insects, birds etc.) might impose a risk of contamination in production of Parma ham. During some stages of drying the hams are placed in so-called well ventilated rooms (se section 2.2), which refer to rooms with open windows, through which pests might be able to enter the production area, unless a filter is placed as it should be according to Regulation No. 852/2004. A pest control program is covered in the prerequisite program (oPRP) (ISO22000:2005; 7.2.3), by which the food plant is protected against pests (Alli, 2004).

Chemical hazards indry cured hams

The chemical hazards in food are a large group of chemical substances of different origin. Examples of chemical hazards are agricultural residues as pesticides or antibiotics, cleaning agents, industrial contaminants, but also the naturally occurring substances such as aflatoxins from mold i

. . .

1 Scope

2 Normative references

3 Terms and definitions

4 Food Safety Management system

4.1 General requirements

4.2 Documentation requirements

4.2.1 General

4.2.2 Control of documents

4.2.3 Control of records

5 Management responsibility

5.1 Management commitment

5.2 Food safety policy

5.3 Food safety management system planning

5.4 Responsibility and authority

5.5 Food safety team leader

5.6 Communication

5.6.1 External communication

5.6.2 Internal communication

5.7 Emergency preparedness and response

5.8 Management review

5.8.1 General

5.8.2 Review input

5.8.3 Review output

6 Resource Management

6.1 Provision of resources

6.2 Human resources

6.2.1 General

6.2.2 Competence, awareness and training

6.3 Infrastructure

6.4 Work environment

7 Purchasing

7.1 Purchasing requirements

7.2 Supplier control process

8 Personnel hygiene

9 Planning and realization of safe products

9.1 General

9.2 Prerequisite programmes (PRPs)

9.2.1 General

9.2.2 Selecting and establishing of PRPs

9.3 Preliminary steps to enable hazard analysis

9.3.1 General

9.3.2 FoodSafetyTeam (HACCP Team)

9.3.3.1 Raw materials, ingredients, and product-contact materials

9.3.3.2 Characteristics of the end product

9.3.4 Intended use

9.3.5 Flow diagrams, process steps and control measures

9.3.5.1 Flow diagrams

9.3.5.2 Description of process steps and control measures

9.4 Hazard analysis

9.4.1 General

9.4.2 Hazard identification and determination of acceptable levels

9.4.2.1 Identification

9.4.2.2 Determination of acceptable levels

9.4.3 Hazard assessment

9.4.4 Selection and assessment of control measures

9.5 Establishing the operational prerequisite programmes (oPRP)

9.6 Establishing the HACCP plan

9.6.1 HACCP plan

9.6.2 Identification of critical control points (CCPs)

9.6.3 Determination of critical limits for critical control points

9.6.4 System for the monitoring of critical control points

9.6.5 Actions when monitoring results exceeds critical limits

9.7 Updating of preliminary information and documents specifying the PRPs and the HACCP plan

9.8 Verification plan

9.9 Traceability system

9.10 Control of nonconformity

9.10.1 Corrections

9.10.2 Corrective actions

9.10.3 Handling of potentially unsafe products

9.10.3.1 General

9.10.3.2 Evaluation for release

9.10.3.3 Disposition of nonconforming products

9.10.4 Withdrawals

10 Validation, verification and improvement of the food safety management system

10.1 General

10.2 Validation of control measure combinations

10.3 Control of monitoring and measuring

10.4 Food safety management system verification

10.4.1 Internal audit

10.4.2 Evaluation of individual verification results

10.4.3 Analysis of results of verification activities

10.5 Improvement

10.5.1 Continual improvement

10.5.2 Updating the food safety management system

Procedures – table of content

For the quality manual the relevant procedures (P) are listed below. Most of the procedures are required in ISO22000:2005 but also additionally procedures of relevance for Fiorucci Food are described. The numbers are in accordance with the numbers in the quality manual.

P.4.2.2 Procedure for control of documents

P.4.2.3 Procedure for control of records

P.5.6.1 Procedure for external communication

P.5.6.2 Procedure for internal communication

P.5.7 Procedure for emergency and response

P.6.2 Procedure for training

P.7.1 Procedure for purchasing requirements

P.7.2 Procedure for supplier control

P.8 Procedure for personnel hygiene

P.9.2.a Procedure for establishing and implementing PRPs

P.9.2.b Procedure for maintaining PRPs

P.9.3.3.1 Procedures for raw material, ingredients and product-contact materials characteristics

P.9.3.3.2 Procedures for characteristics of end products

P.9.4.4 Procedure for selection and assessment of control measures

P.9.5 Procedure for establishing and implementing the operational PRPs

P.9.6.1 Procedure for establishing and implementing the HACCP plan

P.9.6.4 Procedures for monitoring critical control points

P.9.6.5 Procedure when monitoring results exceeds critical limits

P.9.9 Procedure for traceability

P.9.10.1 Procedure for corrections(control of nonconformity)

P.9.10.2 Procedure for corrective and preventive actions

P.9.10.3 Procedure on handling of potentially unsafe products

P.9.10.4 Procedure for withdrawals

P.10.3 Procedure for control of monitoring and measuring

P.10.4.1 Procedure for internal audit

Instructions – table of content

For each procedure Fioruccifood has specified instructions. The instructions define how the procedures should be performed. The numbers are in accordance with the numbers in the quality manual and the procedures.

Instructions (I) for control of documents (Procedure 4.2.2)

I.4.2.2.a Approval of documents for adequacy prior to issue

I.4.2.2.b Review and updating documents

I.4.2.2.c Identification of revised documents

I.4.2.2.d Placement of relevant versions of applicable documents is available at points of use

I.4.2.2.e Identification of documents and how to keep them readable

I.4.2.2.f Identification and distribution of external documents

I.4.2.2.g Identification of outdated documents and prevention of their unintended use.

Instructions for control of records (Procedure 4.2.3)

I.4.2.3.a Identification of records

I.4.2.3.b Storage of records

I.4.2.3.c Protection of records

I.4.2.3.d Retrieval of records

I.4.2.3.e Retention time of records

I.4.2.3.f Disposition of records

Instructions for external communication (Procedure 5.6.1)

I.5.6.1.a Communication with suppliers and contractors

I.5.6.1.b Communication with consumers and customers

I.5.6.1.c Communication with statutory and regulatory authorities

I.5.6.1.d Communication with others than I.5.6.1.a,b or c.

Instructions for Internal communication (Procedure 5.6.2)

I.5.6.2.a Communication concerning changes of products or new products

I.5.6.2.b Communication concerning changes of raw materials, ingredients and services

I.5.6.2.c Communication concerning changes of production systems and equipment

I.5.6.2.d Communication concerning changes of production premises, location of equipment, surrounding environment

I.5.6.2.e Communication concerning changes of cleaning and sanitary programmes

I.5.6.2.f Communication concerning changes of packaging, storage and distribution systems

I.5.6.2.g Communication concerning changes of personnel qualification levels and/or allocation of responsibilities and authorizations

I.5.6.2.h Communication concerning changes of statutory and regulatory requirements

I.5.6.2.i Communication concerning changes of knowledge regarding food safety hazards and control measures

I.5.6.2.j Communication concerning changes of customer, sector and other requirements that the organization observes

I.5.6.2.k Communication of relevant enquiries from external interested parties

I.5.6.2.l Communication of complaints indicating food safety hazards associated with the product

I.5.6.2.m Communication of other conditions that have an impact on food safety

Instructions for emergency and response (Procedure 5.7)

I.5.7.a Management of potential emergency situations and accidents

Instructions for training (Procedure 6.2)

I.6.2.1.a Training and/or education of employees

I.6.2.1.a.a Evaluation of I.6.2.1.a

I.6.2.1.b Retraining of employees

I.6.2.1.c Maintaining appropriate records of training or education

Instructions for purchasing (Procedure 7.1)

I.7.1.a Food safety requirements for purchasing

I.7.1.b Economic guidelines for purchasing

Instructions for supplier control (Procedure 7.2)

I.7.2.a Auditing of suppliers

I.7.2.b Evaluation of supplier audit

Instructions for personnel hygiene (Procedure 8)

I.8.a Illness and injuries

I.8.b Personal hygiene

I.8.c Work clothing

I.8.d Personal items

I.8.2.e Eating, drinking and smoking

I.8.2.f Hand wash

Instructions for establishing and implementing PRPs (procedure 9.2.a)

I.9.2.a.a Construction of buildings and installations

I.9.2.a.b Construction of water supply, energy and other utilities

I.9.2.a.c Construction of work areas and employee facilities

I.9.2.a.d Organisation of production flow

Instructions for maintaining PRPs (procedure 9.2.b)

I.9.2.b.a Maintenance of buildings and installations

I.9.2.b.b Instruction for development of cleaning manual

I.9.2.b.c Disposal of garbage

I.9.2.b.d Pest control

Instructions for characteristics of raw materials, ingredients and product-contact materials (Procedure 9.3.3.1)

I.9.3.3.1.a Characterisation of raw materials, ingredients and product-contact materials

Instructions for characteristics of end products (Procedure 9.3.3.2)

I.9.3.3.2.a Characterisation of end products

Instruction for selection and assessment of control measures (Procedure 9.4.4)

I.9.4.4.a Selection and categorisation of control measures according to whether they need to be managed through oPRPs or CCPs.

Instruction for establishing and implementing operational PRPs (Procedure 9.5)

I.9.5.a Establishing of oPRPs

I.9.5.b Implementation of oPRPs

I.9.5.c Monitoring of oPRPs

Instruction for establishing and implementing the HACCP plan (Procedure 9.6.1)

I.9.6.1.a Establishing of CCPs

I.9.6.1.b Implementation of CCPs

I.9.6.1.c Monitoring of CCPs

Instructions for monitoring critical control points (procedure 9.6.4)

I.9.6.4.a Selection of measurements or observations

I.9.6.4.b Monitoring frequency

I.9.6.4.c Evaluation of monitoring results

Instruction for traceability (Procedure 9.9)

I.9.9.a Traceability

Instructions for corrections (control of nonconformity) (procedure 9.10.1)

I.9.10.1.a Identification and assessment of affected end products to determine their proper handling (see I.9.10.3)

I.9.10.1.b Review of the corrections carried out

Instructions for specifying corrective actions that identify and eliminate the root cause of detected nonconformity (Procedure 9.10.2+9.6.5)

I.9.10.2.a Review of nonconformities(includingcustomer complaints)

I.9.10.2.b Review of monitoring results

I.9.10.2.c Investigation of nonconformities to find the root cause(s)

I.9.10.2.d Determine the need of and implement the needed actions

I.9.10.2.e Validation of the corrective actions

Instructions for handling of potentially unsafe products (Procedure 9.10.3)

I.9.10.3.a Handling of potentially unsafe products

I.9.10.3.b Evaluation of potentially unsafe products

I.9.10.3.c Handling of unsafe products

Instructions for withdrawals (Procedure 9.10.4)

I.9.10.4.a The sequence of actions to be taken in case of withdrawal

I.9.10.4.b Notification to relevant parties

I.9.10.4.c Handling of withdrawn products as well as affected lots of the products still in stock

I.9.10.4.d Verification of the withdrawal programme

Instructions for control of monitoring and measuring (Procedure 10.3)

I.10.3.a Calibration of measuring equipment and methods

I.10.3.b Verification of calibration results of measuring equipment and methods

Instructions for internal audit (procedure 10.4.1)

I.10.4.1.a Auditing

I.10.4.1.b Review of the internal audit

Concluding remarks

A proposal for a food safety management system based on ISO22000:2005 for the production of Parma Ham has been developed. Besides the requirements in ISO22000:2005 two additional chapters, Purchasing and Personnel hygiene, were added to the quality manual. The chapter about Purchasing covers the requirements for raw materials and a supplier control, due to the high importance of the right quality of the raw materials. The chapter about Personnel hygiene is already covered in ISO22000:2005 in chapter 7.2.3, but due to the high importance in food safety it is chosen to pay extra attention to this area as it is a source of contamination and difficult to control.

If the proposed oPRP and HACCP plans were to be implemented, further and more thoroughly hazard assessment should be made, including a more scientific basis. If Felino also carried out slicing of Parma Ham there would be additional hazards such as Listeria to consider.

Before establishing a Parma Ham production, the legal basis of the production within EU and Italian law shall be considered further than the mentioned legislation.

References

Alli, I. (2004): Food quality Assurance, Principles and Practices, CRC Press LLC, Florida, ISBN 1-56676-930-2

Adams, M.R. & Moss, M.O. (2000): Food microbiology. Second edition. The Royal Society of Chemistry.

Directive No. 2000/13 (EC): On the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs, March 20. 2000

Feiner(2006): Meat products handbook: practical science and technology, Cambridge, Woodhead Publishing

Lawrie, R.A. & Ledward, D.A. (2006): Lawrie’s meat science. Seventh edition. Woodhead Publishing.

Luning, P.A., Marcelis, W.J. and Jongen, W.M.F. (2002): Food Quality Management, A techno-managerial approach, Wageningen Academic Publishers, The Netherlands, ISBN 9074134815

Møltoft, J., Drachmann, P., Hansen, K., Jensen, N.C., Jensen, K.E., Kjeldal, B., Kristensen, P.S., Loll, V., Ploug, H.H. and Winther, C.A.D. (1996): Grundbog I Kvalitetsstying og måleteknik, Industriens forlag, 2. edition, ISBN 87-600-0101-1

Regulation No. 178/2002 (EC): Laying down the general principles and requirement of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, January 28. 2002

Regulation No. 510/2006 (EC): On the protection of geographical indications and designations of origin for agricultural products and foodstuffs, March 20. 2006

Regulation No. 852/2004 (EC): On the hygiene of foodstuffs, April 29. 2004

Regulation No. 853/2004 (EC): Laying down specific hygiene rules for food of animal origin, April 29. 2004

Regulation No. 854/2004 (EC): Laying down specific rules for the organization of official controls on products of animal origin intended for human consumption, April 29. 2004

Regulation No. 882/2004 (EC): On official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules, April 29. 2004

Regulation No. 2073/2005 (EC): On microbiological criteria for foodstuffs, November 15. 2005

DS/EN ISO 22000, Copenhagen, DS project 52387, ICS 67:020, (2005-12-22).

Webpages

http://www.adctoday.com/support/qm.php 14. October 2007

www.fioruccifood.it 15. October 2007, 18.October 2007

http://www.fsis.usda.gov/About_FSIS/index.asp 16. October 2007

www.proscuittodiparma.com 17.october 2007

http://www.prosciuttosandaniele.it/en/approfondimenti_vero.asp 16.oktober 2007

USDA: United States Department of Agriculture

FSIS: The Food Safety and Inspection Service is the public health agency in the U.S. Department of Agriculture responsible for ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged. http://www.fsis.usda.gov/About_FSIS/index.asp

iii

Chairman and CEO

Vice president

Vice chairman

Internal

audit

Quality assurance, Research and development

Communication

Administration and Finance

Procurement & Operations

Human Resources and legal affairs

Marketing & Sale

Factory

Langhirano

Factory

Felino

Factory

S. Daniele Del Friuli

Factory

Castel-nuovoRangone

Factory

Richmond USA

Headquarter

S. Palomba

Factory manager*

Human Resources

Quality Assurance

Production* Manager

Maintenance*

Purchase*

Sale*

Microbiology*

Product quality*

Figure 2. Flow sheet of the production of dry-cured hams.

Receiving and inspection of raw materials

Chilling of raw materials to 0°C

Application of salt (25 g/kg meat) Hams are weighed before and after salting

Drying – stage 1

Washing with lukewarm water

Drying – stage 2

Drying – stage 3

Weighing

Flavour development

Drying – stage 4

Weighing

Hams are covered with fat.

Drying – stage 5

Quality

Packaging

Distribution

Quality Manual

Quality Procedures

Work Instructions

Records

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