January 1, 2006
"Hygiene packet" comes in to force

The new community regulations for hygiene in the food processing industry

HACCP systems have had a huge economic impact on the environment, in most outside primary production rules were fixed by a single OCM or worse by voluntary choice. At the end of the 1990s, in order to bolster consumers' confidence, it became necessary to explain and simplify the regulations that covered all productive cycles in order to guarantee the safety of European sanitation policy. All of these measures were assembled like general principles inside the "White book of alimentary security" The White Book spoke about the necessity of having safety rules for foods based on solid scientific proof and redefined safety alimentary tools contained in regulations 178/02 CE. Now comes the introduction of the Hygiene Packet. The Hygiene Packet was born out of the need to simplify and update current laws covering hygiene in the food processing sector. Before the creation of the Hygiene Packet, industry hygiene regulation was spotty at best and relied only on the CEE stamp and self regulation to assure compliance in every sector. The need for broad regulations that cover all work environments remains just as great today as it was in the 1990s.

The Hygiene Packet includes 4 community regulations:

• Regulation (CE) n. 852/04 - Alimentary Hygiene Products;
• Regulation (CE) n. 853/04 - Defines Hygiene Specifications and Rules for Animal Foods;
• Regulation (CE) n. 854/04 - Defines Specification Rules and establishes an Official Agency for the Control of Animal Foods for Human Consumption;
• Regulation (CE) n. 882/04 - Establishes Official Verification Rules for Conformity of Food and Feeds for the Health and Wellbeing of Animals.

The new national rules eliminate some of the old rules and in some instances replace only the parts of the rules that supersede those currently in force.

The following list of directives shows which rules will be totally replaced and which will only be partially replaced:

• Directive (CE) n. 93/43 CEE which defined production process safety, is acknowledged with D.lgs. 155/97 and has been abrogated with reg. 852/04.
• Directive (CE) n. 89/397 CEE defined the general principles for official controls, is acknowledged with D.lgs. 123/93 CEE and has been abrogated by reg. 882/04 CE.

European legislators abrogated directive 2004/41 CE rules as unnecessary for the new Hygiene Packet. The innovations that are observed immediately when new regulations come into force are an obligatory extension of alimentary security into primary alimentary production. This is necessary to guarantee the security of all alimentary processing, imposing upon the primary production operators' respect for and observance of minimum security requirements. (Indicated in attachment 1 part A).

All entrepreneurial entities, like agricultural companies which cultivate or raise livestock and require large storage, refrigeration and distribution facilities, must be identified. This means that each company will have a distinct personal code that is developed for and well-suited to its production cycle. This represents a substantial increase in quality for the food processing industry so that companies will not only be producers but also compliant distributors of more healthy and hygienic food products.

Regulations (CE) n. 852/04, Alimentary Hygiene Products

Article 1. Application area

Present regulations define the general rules for alimentary hygiene products destined for use by alimentary operators and disseminate the following principles:

• Alimentary sector operators are principally responsible for food security;

This increased obligation has lead many companies to assume the lead in all phases of hygienic-sanitary food production and obtain firm commitments from all companies (including agricultural and zootechnic) to participate in the development of a self oversight system. With this system the entrepreneurial will and a sense of responsibility of the producers can be observed, while giving the public the ability to remove some of the bureaucrat procedures;

• It is necessary to guarantee alimentary security throughout the food production chain, starting from alimentary production.

It is clear that this more integrated vision toward the use of only one identification CEE level will bring major flexibility to the industry and confirm good hygienic operations all the way through alimentary production.

• It is important to the integrity of the food-chain that foods which cannot be stored in ambient temperatures follow safety guidelines, particularly for frozen foods;
• Apply procedures based on HACCP rules and correct hygienic procedure, which should increase operator responsibility in the alimentary sector;
• Manuals of correct procedure are precious tools in helping alimentary operator respect and observe hygienic rules in each level of the food-chain applying principles based on HACCP;
• It is necessary to define microbiologic parameters and requirements for temperatures controls that can estimate scientific risk;
• It is necessary to guarantee the consumer community that imported foods are produced to the same hygienic standards of quality utilizing the same or similar rules.

Current regulations must remain in force during all cycles of food production, processing, distribution and exportation, and must meet all scientific requirements for food hygiene.

Art. 5 Risk Analysis and Check Points that defines HACCP System Principles.

HACCP (Hazard Analysis Critical Control Points) system was created to reduce alimentary risks before negative events occur and to take corrective actions so that sanitation risks will always be kept at a minimum. The most important HACCP principles are defined and summarized below:

• Potential risk identification and analysis for foods during various cycles of the production process.
• Instruments with the capacity to identify and neutralize risks (activating control procedures during production cycles which could affect product hygiene).
• Assurance that these instruments work in efficacy mode (Allowing more time controls and instituting control procedures at critical points along the food production chain).

A definition and summary of the general requirements are found in Regulation 852/04; in particular attachment II covers general hygiene requirements. This attachment basically applies to all alimentary operators but excludes those operating in primary food production, which is regulated by attachment 1). In fact there are principles for hygiene foods, for work-stuff operators, for various devices utilized in the industry, etc…. These principles are an in-depth continuation of Regulation 853/04, which addresses the provenance of animal food hygiene.

Regulations (CE) n. 853/04 defines specific hygiene rules for foods of animal provenance.

This regulation is targeted specifically to the European Community: The principal reason for revising the previous rules was to assure consumers of a secure and high quality level of products. Including all alimentary operators in every community under the same rules and regulations attains this high level of operation. This method guarantees proper function of the internal market for animal food provenance so that an agricultural political target can be reached. Inside regulations these rules complete the Regulation. 852/04.

Community regulations 854/04 and 882/04 deal with official control organizations. It is possible that official controls can become a good "certification" tool in a larger system of self-control and tracing organized by the companies themselves Under this structure specific controls are required to oversee secondary sanitary risks of each company utilizing parameter evaluation of hygiene specific self-controls. The controls would be charged to any producer interested in using the best system available to decrease hygienic sanitary risks to his processing production, alleviating public control and decreasing his overall costs.

In the last few pages we have primarily examined the appearance of new Community rules because it is very difficult to describe the newest modifications for each alimentary sector in such a limited amount of space. Below we will discuss how the hygiene rules will be extended with the addition of new rules that are more specific to a single alimentary sector.

Update for new rule " Hygiene Packet "

Regulations (CE) n. 2073/2005 - The Committee for Microbiological Specification for Alimentary Foods, November 15, 2005.

Regulations (CE) n. 2074/2005 - The Committee about Specification for Carry out only for certain products, December 5, 2005 "
(reg.CE n. 853/2004 , reg. CE n.854/2004 , reg. CE 882/2004) as a relaxation of the regulations CE n.852/2004 and modify of reg. CE n. 853/2004 , CE n.854/2004.

Regulations (CE) n. 2075/2005 - The Committee about Specific Rules Regarding Official Controls for Trichinae presence inside meats, November 15, 2005.

Regulations (CE) n. 2076/2005 - The Committee about Fixing Provisory Dispositions for carry- out of Regulations by the European Parliament and Council, November 15, 2005. "
CE n.853/2004 , n.854/2004 , n.882/2004 and modify of reg. CE n. 853/2004 , CE n.854/2004