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I. The European Economic Area (EEA) and the “New Approach.”
The EU1 has developed a system of directives to safeguard public health, as well as to ensure
Conformity to safety and health requirements throughout its member countries and members of
the European Free Trade Association.
In 1994, the EU and the EFTA (with the exception of Switzerland) joined to become the
European Economic Area (EEA). An evolutionary standardization process is underway in the
EEA, with procedures established to cover compliance with directives designed to allow
products legally marketed within one member state to move throughout the rest of the expanded
European community. Moreover, numerous product safety, machinery and electromagnetic
compatibility standards called “ENs” have been published to support the directives’
requirements.
The Council Resolution of 1985 set forth a regulatory scheme leading to technical harmonization
and standardization. This “New Approach” is based on the following principles:
harmonization is limited to essential requirements
only products fulfilling these essential requirements may be enter the market
harmonized standards a presumed to conform to corresponding essential requirements
application of harmonized standards is voluntary: manufacturers may choose any solution
that provides compliance with essential requirements3
manufacturers may choose whatever conformity assessment procedures provided in the
applicable directive
European standards organizations 4 define harmonized standards within the definition of the New
Approach and submit them to the Commission for their possible adoption.
New Approach directives apply to products to enter into the commerce of the EEA, including
new, used, and products imported from third countries. A subject product can only enter the
1EU member countries include Austria, Belgium, Cyprus, Czech Republic, Estonia
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania,
Luxemburg, Netherlands, Poland, Portugal, Spain, Sweden and the United Kingdom..
2EFTA member countries include Iceland, Switzerland, Liechtenstein and Norway.
3Directive 98/34/EC defines European standards as technical specifications adopted by
European standards organizations for consistent use, compliance with which is not obligatory.
4CEN (European Committee for Standardization); Cenelec (European Committee for
Electrotechnical Standardization); and ETSI (European Telecommunication Standards Institute)
commerce of the EEA when it conforms with the provisions of all applicable directives, and
when conformity assessment has been carried out in accordance with all applicable directives.
The intent of New Approach directives is to protect the public interest, including public health
and safety. Their object is to prevent, wherever possible, the placement of unsafe products on
the market.
II. What is CE Marking?
CE marking is an indication that a product complies with the essential requirements of applicable
directives and that the product has been subject to conformity assessment procedures as provided
in the directives. It allows the product to be freely marketed within the EEA. The marking
applies only to products regulated by European health, safety and environmental protection
legislation.
CE marking is the only indication that signifies conformity to all obligations incumbent on
manufacturers for the product as required by the applicable directives providing for its affixing.
CE marking replaces all other requisite conformity markings having the same meaning in
existence before harmonization took place. Other national conformity markings would constitute
an infringement on applicable New Approach directives.
Consumers may erroneously believe that CE marking is a quality symbol or a marketing tool.
CE marking is the declaration by the manufacturer (and acceptance by a European-authorized
conformity assessment body for higher risk medical devices) that the product complies with all
applicable directives. CE marking relates to the national surveillance authorities or “designated
authorities” of the member states. The declaration of conformity filed with the application for
CE marking contains the details of the directive(s) to which the product complies and the
standards that were relied upon in assuring compliance.
The directives provided for CE marking generally follow the principles of the New Approach.
Significance for Manufacturers and Exporters
The clearest benefit in CE marking is that it results in only one set of laws and regulations to
comply with in designing and manufacturing for the entire expanded European marketplace. The
multiple and conflicting national restrictions on regulated products are eliminated.
5To promote public safety, the Product Liability Directive (84/374/EEC) (see section IV
below) pertains to all products covered by New Approach Directives. This directive applies to
defective products only, placing the liability on the producer.
Additional benefits may include products being made safer for consumers as well as reduced
damage claims and liability premiums.
With this harmonization come other issues that may cause difficulties to experienced firms
exporting to the European market. The new product directives may exceed current national laws
and regulations in some European countries. These increased or new requirements may require a
manufacturer to change its design or production processes to continue or enter into this market.
Products not bearing CE marking would not be in compliance with the directives, might be
restricted, prohibited from sale, or forced to withdraw from the expanded European market.
The manufacturer must remain in control of production and retain the necessary competence to
take responsibility for the product. The manufacturer is also obliged to be accountable that a
product intended to be placed in the commerce of the EEA is in conformity with the essential
requirements in accordance with the provisions of the applicable New Approach directives. To
that end, the directives require that a responsible person or “authorized representative” be
accountable in Europe to ensure adherence to these directives. This authorized representative
must have a legal presence in Europe and declare that all requirements for applicable directives
have been met.
III. Which products require CE Marking?
In addition to medical devices, including active implantable and in vitro diagnostic devices6, the
following products require CE marking to enter into the commerce of the EEA:
Toys
Construction products
Pressure vessels
Telecommunication equipment
Machinery
Personal protective equipment
Satellite station equipment
Gas appliances
Pressure vessel equipment
Appliances (other than gas)
Recreational craft
Elevator equipment
Equipment and protective systems for explosive atmospheres
Non-automatic weighing equipment
Measuring instruments
6Custom- made devices and devices intended for clinical investigations are exempt from
the CE marking requirement.
Marine equipment
Electrical products
Civil explosives
IV. Procedures for CE Marking
Before CE marking can be affixed to the product, the manufacturer must follow certain
procedures which may differ for each directive and each product.
A manufacturer must 1) identify which New Approach directives apply to the product; 2) prepare
the Declaration of Conformity, 3) draw up the Technical Construction File (TCF)7, and 4)
compile the CE User Manual.
Directives Which May Apply to Particular Medical Devices
Before application of the mandatory CE marking, certain products may need to comply with
more than one directive. If a product is subject to several directives providing for CE marking,
the marking indicates that the product conforms to the provisions of all these directives.
Following are some directives that may affect manufacturers of medical devices:
$ Medical Device Directive (MDD): 93/42/EEC.
This directive concerns many medical products defined, in part, as “any instrument... or
other article... to be used on human beings for the purpose of:
diagnosis, prevention, monitoring, treatment or alleviation of disease;
diagnosis, monitoring, treatment, alleviation of or compensation for any injury or
handicap;
investigation, replacement, or modification of the anatomy or of a physiological
process; and
which does not achieve its principal intended action in or on the human body by
pharmacological, immunological or metabolic means, but which may be assisted in its
function by such means...”
7In the case of Class III (highest risk) medical devices, the manufacturer must prepare a
Design Dossier in lieu of a TCF.
Specific MDD procedures require medical device manufacturers to adhere to specific provisions
for conformity assessment. These procedures are based on risk assessment categories
established by the MDD: Class I, Class IIa, Class IIb, and Class III8. For more information on
these special provisions,
Active Implantable Medical Devices: (90/385/EEC).
This directive concerns products defined as any medical device intended to be introduced
into the human body which is intended to remain after the procedure.
In Vitro Directive (98/79EEC).
This directive, which will become effective in December 2003, concerns itself with the
elimination or reduction of infection related to in vitro diagnostic medical devices. These
devices include blood glucose monitoring systems for management of diabetes as well as
all other medical diagnostic devices used outside the body.
Low-Voltage Directive: (73/23/EEC).
This directive concerns products with 50 to 1000 VAC or 75-1500 VDC input. This
directive has been in effect since 1973 and was amended by 93/68/EEC9 by adding the
CE marking requirement.
Electro-Magnetic Compatibility (EMC) Directive: 89/336/EEC.
Medical devices are required to meet this directive that sets the specifications for control
of emissions and immunity.
Machinery Safety Directive: 98/37/EEC.
This directive applies to risks arising from the use of machinery and specific safety
components.
Besides these directives, there are others called Basic Directives that apply to all manufacturers.
These Basic Directives concern trade, enforcement, liability and other issues. Besides the
Product Liability Directive (85/374/EEC) mentioned above, some of the Basic Directives
include:
8These same risk classes apply to active implantable and in vitro medical devices, and
generally correspond to FDA risk categories, with the exception that FDA category Class II does
not subdivide in to Class IIa, and Class IIb. Risk assessment is based on three principles: the
continuous use of the device, its degree of invasiveness, and if the device is implantable.
9Directive 93/68/EEC also describes the proper application of CE marking, described in
section V below.
General Product Safety Directive: 92/59/EEC
Conformity Assessment Procedures and CE Marking Rules: 93/465/EEC
CE Marking Amendment: (Rules for Affixing and Use of CE Conformity Marking)
93/68/EEC – amends most of the above- mentioned directives.
These lists are not exhaustive, and not all medical devices would be deemed to necessarily be in
compliance with each of these directives. Furthermore, the directives are subject to change. For
updated information on EC directives,
Declaration of Conformity: The declaration of conformity must contain the following
information: product identification; the EU directives with which the product complies;
standards used to verify compliance with the directives; name of the Notified Body10 used (if its
use is required by applicable directives – see below); signature on behalf of the manufacturer or
the authorized representative; and the manufacturer's name and address.
Technical Construction File (TCF): Most directives require the manufacturer or the authorized
representative to provide a technical file which demonstrates the technical basis for conformity
of the product to the requirements of the directive. The manufacturer must implement internal
measures to ensure that the product remains in conformity. The file is intended essentially for
the use of competent authorities. The TCF must be kept at the disposal of national surveillance
authorities (called Designated Authorities for medical devices) for inspection and control
purposes, and be available for at least ten years, starting from the production date of the final
product. The main elements comprising a TCF are the following:
description of the product;
design and production drawing and diagrams;
detailed technical data for essential aspects of the product;
list of standards and or solutions applied;
report of calculations and tests that have been carried out;
certificate and inspection reports; and
in the case of series production, the internal conditions that have been observed to
safeguard compliance with the directive.
10Notified Bodies are independent testing facilities or laboratories authorized by EEA
member states to perform the conformity assessment tasks specified in directives. Manufacturers
and exporters may choose a Notified Body in any EEA member state. Notified Bodies may be
authorized for specific industries or specific products. For a current list of Notified Bodies
CE User Manual: Information provided to a user plays an essential role in avoiding or reducing
safety risks. Thus, a user manual is often an essential safety requirement. A user manual must
contain all the information required for the correct and safe use of a product.
Language Requirements
EEA Member States have dictated that their national language(s) must appear on device
packaging, labels and user manuals when the product is sold in their country. Advertising
slogans, the name of the manufacturer and authorized representative address are exempt from
this requirement.
Putting it all together: Evaluation of Conformity
For most products, depending upon the product and the nature of the risks it presents, there are
several routes to evaluation of conformity and the ultimate CE marking of a product. An
assessment must be made and documented in the manufacturer’s TCF before CE marking is
affixed and before the product is made available or put into service.
After determining which directive or directives apply to the product and establishment of
conformity with the essential requirements for design and manufacturing to the applicable
directives, the manufacturer must determine conformity assessment procedures from the options
each directive prescribes. The guidelines often use a series of questions about the nature of the
product to classify the level of risk. For more information on these guidelines,
When must a Notified Body be used?
Options for medical devices with minimal risk include self- certification where the manufacturer
prepares a declaration of conformity and affixes the CE marking to the product. Other products
with greater risks call for voluntary certification by a Notified Body. Other medical devices may
not be self-certified, but must be subjected to the EC type-examination. This examination
involves the inspection of a representative example by or on behalf of an external inspection
organization or Notified Body within the EEA. Devices with even greater risks require tests,
audits or additional certificates from a Notified Body before CE marking can be affixed.
Another avenue for U.S. manufacturers of medical devices to access the EU market is using the
procedures outlined in the Medical Device Annex of the U.S. - EU Mutual Recognition
11These requirements concern CE marking only. Member states may have additional
language requirements that do not conflict with these.
Agreement. For information on this agreement
V. Finally: Affixing the CE Marking
Directive 93/86/EEC delineates the requirements for how CE marking should ultimately be
affixed. CE marking must be affixed to the product, or, when this is not possible to its
packaging, if any, and to the accompanying documents by the manufacturer, the authorized
representative in the community or, in exceptional cases, by those responsible for placing the
product on the market. Where special provisions do not impose specific dimensions, CE
marking must have a height of at least five (5) millimeters. When an Notified Body is used, its
number must appear below the CE marking.
The actual CE marking is the letters “CE:” an abbreviation of a French phrase “Conformité
Europeans.” The marking indicates that the manufacturer has conformed with all the
obligations required by the legislation. Initially, the phrase was “CE mark:” however, the term
“CE marking” was legislated as its replacement in 1993.
VI. For More Information on Policies Concerning Your Exports of Medical Devices to
Europe
For general product legislation,
For detailed information regarding the New Approach and how it applies to CE Marking
Additional up-to-date details on CE marking are available in the Official Journal of the European
Communities.
CE Mark
CE Marking Directive requirements and gain market access into the European Union, there are four European Union-based Notified Bodies located in Germany, Sweden, and two in the United Kingdom.
As a manufacturer, or importer if the manufacturer is based outside of the EU, you must always provide proper documentation as a basis for CE marking, which proves that the product meets the requirements of the applicable product directives. We have the product expertise and full capability to test to a variety of directives including:
• ATEX Directive
• Construction Products Directive (CPD) – Directive 89/106/EEC
• EuP Directive 2009/125/EC (Formerly EuP)
• Low Voltage Directive
• EMC Directive (2004/108/EC)
• Gas Appliance Directive
• In-Vitro Diagnostic Directive
• R&TTE Directive
• Medical Device Directive
• Machinery Directive (2006/42/EC)
Obtaining the CE Mark
Before the CE Mark may be affixed to a product and legally sold within the European Union, the manufacturer or exporter must complete the following:
• Prepare Technical Documentation (Technical File) to show the product’s compliance with applicable essential requirements and conformity assessment procedures of the applicable device directive.
• Prepare a "declaration of conformity" which means that you, as a manufacturer, declare that your product fulfills the requirements of the applicable directive.
• According to some directives you must also receive a product-specific CE marking certificate from a Notified Body.
Navigating the CE marking process does not have to be complicated. In fact, getting a CE mark as easy as the following steps:
1. Determine which directive is applicable to your product
2. Fulfill the essential requirements - Ensure that your product fulfills the essential requirements of the relevant product directive.
3. Establish a monitoring system - As a manufacturer, you are required to monitor your products once they are on the market, in case necessary updates must be made in accordance with updated standards or international requirements.
4. Establish an accident reporting system - If an accident or near-accident involving any of your products takes place, you are obliged to report this to appropriate authorities.
5. Issue a Declaration of Conformity
6. Save the documentation for ten years - Declaration of conformity, technical documentation, reports, and certificates from the Notified Body etc. must be kept for at least ten years after the product has been taken out of production.
7. Register with the appropriate governing body within Europe
The CE marking (also known as CE mark) is a mandatory conformance mark on many products placed on the single market in the European Economic Area (EEA). The CE marking certifies that a product has met EU consumer safety, health or environmental requirements. Originally "CE" stood for ("Communauté Européenne") "European Community". According to the European Commission today the CE logo has become a symbol for free marketability of industrial goods within the EEA without any literal meaning. By affixing the CE marking to a product, the manufacturer – on his sole responsibility – declares that it meets EU safety and health and environmental requirements.
Meaning
• Countries requiring the CE marking
• Rules underlying CE marking
• Self declaration
• Declaration of conformity
• Legal implications
• Product groups
• Mutual recognition of conformity assessment
• Characteristics of the CE marking
• Dimensions
• The e mark
• Misuse
o Confusing CE marks
• China export
Dairy Foods HACCP Standard and Controls Guide
Guidance for Processors
Table of Contents
I. Introduction
A. Status 1
B. Purpose 1
C. Comparison with the FDA Juice HACCP Regulations 1
D. Scope and Limitations 3
II. Terms and Definitions 4
III. Overview of the SHIV SHAKTI SERVICES HACCP Program
A. Voluntary Nature of the Program 6
B. Key Requirements of the SHIV SHAKTI SERVICES HACCP Program 6
IV. Prerequisite Programs
A. Required Prerequisite Programs 9
B. Acceptable Level of Protection by Prerequisite Programs 10
V. Hazard Analysis
A. Preparing for a Hazard Analysis – Five Preliminary Steps 11
B. Overview of the Hazard Analysis 11
VI. HACCP Decision Trees
A. SHIV SHAKTI SERVICES CCP Decision Tree #1 22
B. SHIV SHAKTI SERVICES CCP Decision Tree #2 23
C. IDFA Modified Decision Tree for HACCP 24
VII. Control Measures
A. HACCP Control Measures 25
B.Activities Not Considered to be HACCP Control Measures 25
VIII. Preparing for HACCP
A. Getting People Ready 26
B. HACCP Training and HACCP Resource Materials 26
IX. Hazards and Control Guide
A. Table 1 – Milk Plant Raw Materials 28
B. Table 2 – Milk Plant Processing Operations 30
X. References 59
I. Introduction
A. Status
This Hazards and Controls Guide represents the National Conference on Interstate Milk Shipments (SHIV SHAKTI SERVICES) perspective on identifying and evaluating potential hazards in milk and milk products and their control. It is designed to assist processors in the development of Hazard Analysis Critical Control Point (HACCP) systems to satisfy the requirements of the SHIV SHAKTI SERVICES HACCP alternative to the traditional regulatory system for Grade A dairy products that are regulated by the states under the SHIV SHAKTI SERVICES milk safety system. The guide should also be useful to State Regulators who are responsible for the evaluating the completeness of a plants hazard analysis.
This Hazards and Controls Guide provides a framework for answering some of the questions to be considered when conducting a hazard analysis for the processing of milk and milk products.
This guide has been separated into two parts. The first part provides background information that can be useful in understanding the basic food safety concerns and goals to be addressed by the hazard analysis. The second part of the hazard guide is an evaluation of specific potential hazards associated with the processing of milk and milk products. It is also divided into two major sections. The first section identifies many potential food safety hazards associated with ingredients and packaging materials. In the second section, a “unit operations” approach has been used to identify food safety potential hazards which may be associated with processing.
HACCP, as it relates to the SHIV SHAKTI SERVICES HACCP alternative, is a food safety system whose design is based on practical experience and the scientific understanding of the potential hazards associated with various types of milk and milk products. References to the available scientific literature can be found throughout this document. A list of references can be found at the end of this guide.
B. Purpose
The purpose of this guidance is to assist you in the development of a written HACCP program, as defined by the SHIV SHAKTI SERVICES Voluntary HACCP System. You will find information in this guidance that will help you identify hazards that may potentially occur in your products and help you identify and use methods of controlling and preventing hazards. This guidance is also intended to serve as a tool for Federal and State regulatory officials in the evaluation of HACCP systems for dairy products.
To help understand some key aspects of the SHIV SHAKTI SERVICES Voluntary HACCP System and plan how you will initiate your HACCP activities, we have included information on some other important aspects of the Dairy HACCP System.
C. Comparison with the FDA Juice HACCP Regulations
The following table is provided to dairy processors as a visual comparison of the FDA Juice HACCP regulations and the SHIV SHAKTI SERVICES Voluntary Dairy System.
Requirements | ||
Regulation Implementation Dates: | 1/22/02 Large Business (>500 employees) 1/21/03 for Small Business (<500 employees) 1/20/04 for Very Small Businesses (<100 employees) | January 1, 2004 |
Prerequisite Program Concept | Yes (GMP & SSOP) | Yes (PP) |
Written Sanitation Standard Operating Procedure (SSOP) or Required PP | No | Yes |
Sanitation Monitoring & Documentation (SSOP) or Required PP | Yes (8 elements) | Yes (8 elements) |
Perform Hazard Analysis | Yes | Yes |
Written Hazard Analysis | Yes | Yes |
Written HACCP Plan | Yes | Yes |
Written Corrective Action Plan Required: | Yes | Yes |
HACCP Plan shall be signed and dated | Yes, updated annually | Yes |
Plan Revalidation Upon plan development | Yes, at least once within 12 months of implementation | Yes |
Upon any change that affect ingredients, process, hazard analysis or HACCP Plan | Yes | Yes |
At least annually | Yes | Yes |
Regulator Consumer Complaint Record Access | No | No |
Maintain Customer Complaint Summary | Yes | Yes |
Monitoring & Corrective Action Records Review | Within 7 days | No minimum specified, appropriate to records being kept |
Required Info on Records | Yes Yes | |
Name & Location Date & Time | Yes (if more than 1 location) Yes | |
Monitor’s Initials or Signature | Yes, where appropriate | Yes |
ID of product & Code | Yes, where appropriate | Yes |
Record Retention | 1 year after the production of the product | At least 1 year after the date that such products were prepared. |
2 years for frozen, preserved or shelf stable, or the shelf life of the product, whichever is greater. | In the case of frozen, preserved or shelf stable products 2 years or the shelf life of the product whichever is greater, after the date that the products were prepared unless longer retention time is required by other regulations. | |
Industry Training (HACCP plan developers, validators and record reviewers) or equivalent experience | Yes (Juice HACCP Core Curriculum) | YES (SHIV SHAKTI SERVICES Dairy HACCP Core Curriculum) |
Confidentiality | Yes, within the limits of FOIA | Not Addressed |
Copying Records | Yes | Not Addressed |
Electronic Records | Yes | Yes |
. |
D. Scope and Limitations
This guide addresses development of a product flow diagram, description of the product, hazard identification and hazard evaluation. It is not intended to provide examples for development of prerequisite programs, formation of the HACCP team, product distribution, risk analysis, etc.
Prior to conducting the hazard analysis, the HACCP team must complete the following preliminary steps:
1. Develop a product description;
2. Develop and verify a process flow diagram
3. Describe the intended use and distribution parameters.
II. Terms and Definitions
A. AUDIT: An evaluation of the entire milk plant, receiving station or transfer station facility and SHIV SHAKTI SERVICES HACCP System to ensure compliance with the SHIV SHAKTI SERVICES HACCP System and other SHIV SHAKTI SERVICES regulatory requirements.
B. Centralized Deviation Log: A centralized log or file identifying data detailing any deviation of critical limits and the corrective actions taken as required in Appendix K of the Pasteurized Milk Ordinance (PMO).
C. Control: To manage the conditions of an operation to maintain compliance with established criteria. The state where correct procedures are being followed and criteria are being met.
D. Control Measure: Any action or activity that can be used to prevent, eliminate or reduce a significant hazard that is managed at a Critical Control Point.
E. Corrective Action: Procedures followed when a deviation occurs.
F. Critical Control Point (CCP): A step at which control can be applied and is essential to prevent or eliminate a milk or milk product safety hazard or reduce it to an acceptable level.
G. Critical Limit (CL): A maximum and/or minimum value to which a biological, chemical, or physical parameter must be controlled at a CCP to prevent, eliminate, or reduce to an acceptable level the occurrence of a milk or milk product safety hazard.
H. CRITICAL LISTING ELEMENT (CLE): An item on the MILK PLANT, RECEIVING STATION OR TRANSFER STATION SHIV SHAKTI SERVICES HACCP SYSTEM AUDIT REPORT identified with a double star (**). The marking of a CLE by a State Rating Officer or FDA auditor, indicates a condition that constitutes a major dysfunction likely to result in a potential compromise to milk or milk product safety, or that violate SHIV SHAKTI SERVICES requirements regarding drug residue testing and trace back or raw milk sources, whereby a listing may be denied or withdrawn.
I. DAIRY HACCP CORE CURRICULUM: The core curriculum consists of:
1. Basic HACCP training; plus
2. An orientation to the requirements of the HACCP Program
J. DEFICIENCY: An element inadequate or missing from the requirements of the HACCP System or Appendix K of the PMO.
K. DEVIATION: A failure to meet a Critical Limit.
L. FOOD ALLERGENS: Are proteins in foods that are capable of inducing an allergic reaction or response in some individuals. There is specific consensus that the following foods account for more than 90% of all food allergies: peanuts, soybeans, milk, eggs, fish, crustaceans, tree nuts, and wheat.
M. HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP): A Systematic approach to the identification, evaluation, and control of significant milk or milk product safety hazards.
N. HACCP PLAN: The written document, which is based upon the principles of HACCP and delineates the procedures to be followed.
O. HACCP SYSTEM: The implemented HACCP Plant and Prerequisite Program, including other applicable SHIV SHAKTI SERVICES requirements.
P. HACCP TEAM: The group of people who are responsible for developing, implementing, and maintaining the HACCP system.
Q. HAZARD: A biological, chemical, or physical agent that is reasonable likely to cause illness or injury in the absence of its control.
R. HAZARD ANALYSIS: The process of collecting and evaluating information on hazards associated with the milk under consideration, to decide which are reasonable likely to occur and must be addressed in the HACCP Plan.
S. MONITOR: To conduct a planned sequence of observations or measurements to assess that a CCP is under control or to assess the conditions and practices of all required Prerequisite Programs.
T. NON-CONFORMITY: A failure to meet specified requirements of the HACCP System as described in Appendix K of the PMO.
U. POTENTIAL HAZARD: Any hazard to be evaluated by the hazard analysis.
V. PREREQUISITE PROGRAMS (PP’s): Procedures, including Good Manufacturing Practices (GMP’s), which address operational conditions that provide the foundation for the HACCP System. The required PP’s specified in Appendix K of the PMO, are something called Sanitary Standard Operating Procedures (SSOP’s) in other HACCP Systems.
W. VALIDATION: The element of verification focused on collecting and evaluating scientific and technical information to determine whether the HACCP Plan, when properly implemented, will effectively control the hazards.
X. VERIFICATION: Those activities, other than monitoring, that determine the validity of the HACCP Plan and that the HACCP System is operating according to the plan.
III. Overview of the SHIV SHAKTI SERVICES HACCP Program
The following section is a brief synopsis of Appendix K of the PMO detailing the requirements of the SHIV SHAKTI SERVICES alternative HACCP program. For a complete understanding of the SHIV SHAKTI SERVICES HACCP Alternative, please refer to the most recent version of the PMO.
A. Voluntary Nature of the Program
The SHIV SHAKTI SERVICES HACCP Program alternative to the traditional inspection system is a voluntary system as described in the applicable sections and Appendices of the Pasteurized Milk Ordinance (PMO). No plant, receiving station or transfer station may participate in the voluntary SHIV SHAKTI SERVICES HACCP Program unless the Regulatory Agency responsible for the oversight of the facility agrees to participate with the dairy plant(s), receiving station(s) and transfer station(s) in the SHIV SHAKTI SERVICES HACCP Program. Both parties must provide written commitment to each other that the necessary resources to support participation in the SHIV SHAKTI SERVICES HACCP Program will be made available. Management responsible for both the State and plant, receiving station or transfer station must be willing to provide the resources needed to develop and implement a successful HACCP System.
B. Key Requirements of the SHIV SHAKTI SERVICES HACCP Program
1. Specialized Training in SHIV SHAKTI SERVICES HACCP Principles Required
HACCP training for industry and regulatory personnel will be based on the current “Hazard Analysis and Critical Control Point Principles and Application Guidelines” of SHIV SHAKTI SERVICES, the current FDA HACCP recommendations, and the regulatory requirements of Appendix K and related Sections of the PMO.
Regulatory Agency personnel responsible for the evaluation, licensing and regulatory audits of facilities using the SHIV SHAKTI SERVICES HACCP Program will have equivalent training to the training required to perform traditional SHIV SHAKTI SERVICES functions. They shall also have specialized training in conducting HACCP System audits.
Industry, State and Federal regulatory and listing personnel should be trained together.
a. HACCP Training
¨ Core Curriculum: The Dairy HACCP Core curriculum consists of:
1. Basic HACCP training; plus
2. An orientation to the requirements of the SHIV SHAKTI SERVICES HACCP Program.
Basic HACCP training consists of instruction in the application of the SHIV SHAKTI SERVICES Principles of HACCP to Food Safety. This training includes practical exercises in conducting a hazard analysis and evaluating potential hazards; in writing a HACCP Plan, and in the validation of the plan. It should be taught by experienced instructors.
The orientation component ideally is coupled with the basic HACCP training, but can be taught separately. The content of the orientation will be conducted under the guidance of the SHIV SHAKTI SERVICES. It is intended to familiarize industry and regulatory personnel with specific dairy HACCP concerns and the regulatory requirements under the SHIV SHAKTI SERVICES HACCP Program. It is to be taught by instructors experienced in the application of HACCP under the SHIV SHAKTI SERVICES HACCP Program.
The industry individual(s) performing the functions listed in Part 2 of this Section shall have successfully completed appropriate training in the application of HACCP principles to milk and milk product processing at least equivalent to that received under the Dairy HACCP Core Curriculum. Alternatively, job experience may qualify an individual to perform these functions if the experience has provided knowledge at least equivalent to that provided through the standardized curriculum.
· Industry Personnel: Only industry individuals who have met the requirements of Part 1 of Appendix K Section III of the Pasteurized Milk Ordinance (PMO) - Training and Standardization, shall be responsible for the following functions.
a. Developing the hazard analysis, including delineating control measures as required.
b. Developing a HACCP Plan that is appropriate for the specific milk plant, receiving station or transfer station, in order to meet these requirements.
c. Validating and modifying the HACCP Plan in accordance with the corrective action procedures and the validation activities as specified; and
d. Performing required HACCP Plan records reviews.
· Regulatory Personnel: Regulatory personnel performing HACCP audits shall have successfully completed the appropriate training in the application of HACCP principles for milk and milk product processing at least equivalent to that received under the Dairy HACCP Core Curriculum.
2. Recordkeeping and Electronic Records
a. Required Records: It is essential that plants, receiving stations and transfer stations use consistent terminology to identify each piece of equipment, record, document, or other program throughout their written HACCP System. A milk plant, receiving station or transfer station shall maintain the following records documenting the milk plant, receiving station or transfer station’s HACCP System:
· A brief description of the monitoring and correction records shall be written documenting the ongoing application of the prerequisite program.
· A hazard analysis shall be written
· The written HACCP Plan;
· Required HACCP documents and forms specified in a.1) through 3) of this Section shall be dated or identified with a version number. Each page shall be marked with a new date or version number whenever that page is updated.
· A Table of Contents and centralized list of the HACCP program records, by title, documenting the ongoing application of the HACCP System shall be maintained and provided for review.
· A document change log shall be kept.
· Records documenting the ongoing application of the HACCP Plan that include:
1. Monitoring of Critical Control Points and their Critical Limits, including the recording of actual times, temperatures, or other measurements, as prescribed in the plant’s receiving station’s or transfer station’s HACCP Plan;
a. Corrective actions, including all actions taken in response to a deviation.
b. A centralized deviation log is required; and
c. Plan validation dates.
d. Records documenting verification and validation of the HACCP System, including the HACCP Plan, hazard analysis and PP’s.
2. General Requirements: Records required include:
a. The identity and location of the milk plant, receiving station or transfer station;
b. The date and time of the activity that the record reflects;
c. The signature or initials of the person(s) performing the operation or creating the record; and
d. Where appropriate, the identity of the product and the production code, if any. Processing and other information shall be entered on records at the time that it is observed. The records shall contain the actual values and observations obtained during monitoring.
3. Documentation:
a. The records in paragraphs a.1) through 3) of this Section shall be signed and dated by the most responsible individual onsite at the milk plant, receiving station or transfer station. This signature shall signify that these records have been accepted by the firm.
b. The records in paragraphs a.1) through 3) of this Section shall be signed and dated:
1. Upon initial acceptance;
2. Upon any modification; and
3. Upon verification and validation in accordance with the requirements cited above
4. Record Retention:
a. All records, required by this section, shall be retained at the milk plant, receiving station or transfer station for perishable or refrigerated products, for at least one (1) year after the date that such products were prepared, and in the case of frozen, preserved, or shelf-stable products, for two (2) years after the date that the products were prepared or the shelf-life of the product, whichever is greater, unless longer retention time is required by other regulations.
b. Records that relate to the adequacy of equipment or processes used, such as commissioning or process validation records, including the results of scientific studies and evaluations, shall be retained at the milk plant, receiving station or transfer station facility for at least two (2) years after the date that the milk plant, receiving station or transfer station last used such equipment or process.
c. Off-site storage of processing records is permitted after six (6) months following the date that the monitoring occurred, if such records can be retrieved and provided on-site within twenty-four (24) hours of a requires for official review. Electronic records are considered to be on-site if they are accessible from an on-site location.
IV. Prerequisite Programs
The following required Prerequisite Programs shall have a brief written description or checklist that the prerequisite programs can be audited against to ensure compliance. Prerequisite Programs shall include procedures that can be monitored, records that specify what is monitored, and how often it will be monitored.
A. Required Prerequisite Programs
1. Safety of the water that comes into contact with milk or milk products or product contact surfaces, including steam and ice.
2. Condition and cleanliness of equipment product contact surface.
3. Prevention of cross-contamination from unsanitary objects and or practices to milk or milk products or product contact surfaces, packaging material and other food contact surfaces, including utensils, gloves, outer garments, etc., and from raw product to processed product;
4. Maintenance of hand washing, hand sanitizing and toilet facilities.
5. Protection of milk or milk product, packaging material, and product contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate and other chemical, physical and biological contaminants;
6. Proper labeling, storage and use of toxic compounds;
7. Control of employee health conditions, including employee exposure to high risk situations, that could result in the microbiological contamination of milk or milk products, package materials, and product contact surfaces; and
8. Exclusion of pests.
9. Required Programs (PP’s) used as justification in the Hazard Analysis
In addition to the required PP’s specified above, any other prerequisite programs that are being relied upon in the Hazard Analysis to reduce the likelihood of occurrence of hazards such that they are not reasonably likely to occur must also be monitored, audited, and documented as required PP’s.
B. Acceptable level of protection by prerequisite programs
Prior to the implementation of a HACCP Plan, there is a requirement for dairy plants, receiving stations and transfer stations to develop, document and implement written PP’s. PP’s provide the basic environment and operating conditions that are necessary for the production of safe, wholesome food. Many of the conditions and practices are specified in Federal and State regulations and guidelines.
HACCP is not a stand-alone program, but is part of a larger control system. PP’s are the universal procedures used to control the conditions of the plant environment that contribute to the overall safety of the product. They represent the sum of programs, practices and procedures that must be applied to produce and distribute safe products in a clean, sanitary environment. They differ from CCP’s in that they are basic sanitation programs that reduce the potential occurrence of a milk or milk product safety hazard. Frequently, both HACCP Plan CCP’s and PP’s control measures are necessary to control a food safety hazard.
HACCP may be implemented only in a facility that is constructed and operated to provide a sanitary environment. Milk plant, receiving station or transfer station premises, building construction, maintenance, and housekeeping shall be maintained in a manner sufficient to provide such an environment. These factors shall be controlled by effective plant, receiving station or transfer station programs or by PP’s, as the plant, receiving station or transfer station chooses.
PPs are the universal procedures used to control the condition of the plant environment that contribute to the overall safety of the product. They represent the sum of programs, practices and procedures that must be applied to produce and distribute safe products in a clean, sanitary environment. They differ from CCP's in that they are basic sanitation programs that reduce the potential occurrence of a food safety hazard. Frequently, both HACCP Plan CCP’s and PP's control measures are necessary to control a food safety hazard. The exact set of PP’s will vary since their application is product and process specific. The existence and effectiveness of PP’s should be assessed during the design and implementation of each HACCP Plan. PP’s should be documented and regularly audited. An audit review consists of verifying that the company has a program implemented that indicates how the company monitors and controls each of the PP’s. PP’s are established and managed separately from the HACCP Plan.
V. Hazard Analysis
A. Preparing for a Hazard Analysis – Five Preliminary Steps
Although not required by the SHIV SHAKTI SERVICES HACCP alternative, the 5 preliminary steps of HACCP as outlined by the National Advisory Committee of Microbiological Criteria for Foods (SHIV SHAKTI SERVICES) will help you in conducting your hazard analysis and developing your HACCP plan, and will prove valuable for other HACCP functions. The steps you should follow are:
1. Step 1 Assemble a HACCP Team.
2. Step 2 Describe the food and its distribution.
3. Step 3 Identify the intended use and consumers of the food.
4. Step 4 Develop a flow diagram that describes the process.
5. Step 5 Verify the accuracy of the flow diagram.
For more information, see the SHIV SHAKTI SERVICES publication “Hazard Analysis and Critical Control Point Principles and Application Guidelines,” Journal of Food Protection, Vol. 61, No. 9, pp. 1246-1259 (1998), (the “HACCP Principles and Guidelines” publication).
B. Overview of the Hazard Analysis
1. Description
The dairy hazard analysis is a process of collecting and evaluating information on hazards associated with dairy products, to determine which hazards are reasonably likely to occur and must be addressed in a HACCP Plan. Under the dairy HACCP alternative, you are required to produce, for each type of Grade A dairy product you process, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur and to identify measures that you can apply to control those hazards. The dairy alternative requires a written hazard analysis for each type of dairy product unless different types of dairy products have identical hazards and control measures that can be combined into one hazard analysis.
Do not conduct the hazard analysis until the prerequisite programs have been developed, implemented and documented. This Hazard and Controls Guide may be used to aid in constructing and evaluating those prerequisite programs to be considered in the hazard analysis. The hazard analysis may point out the need for additional prerequisites.
2. Relevance to HACCP Plan and Prerequisite Programs
All processors that decide to participate in the SHIV SHAKTI SERVICES HACCP alternative are required to prepare a written hazard analysis. If you determine that any hazard is “reasonably likely to occur” in a particular product, you must control that hazard in the product by applying control measures as part of a properly designed and implemented HACCP plan, except that some hazards can be managed under your PP’s. If you determine that no hazards are “reasonably likely to occur,” you are not required to develop a HACCP Plan, but you must establish and implement PP’s. Your PP monitoring and correction records and your hazard analysis are still subject to the record keeping and official record review requirements. Under the SHIV SHAKTI SERVICES HACCP system, pasteurization must always be managed as a CCP. Useful examples of both batch and continuous flow pasteurization can be found in the PMO, Appendix H.
3. Developed by HACCP-trained Employee or Consultant
Your hazard analysis must be developed by an appropriately trained individual (or individuals) based on the Core Curriculum or comparable experience, as specified in the SHIV SHAKTI SERVICES HACCP Alternative. This person may be your employee or a hired outside expert.
4. Basic Steps of the Hazard Analysis
a. Identify All Potential Hazards
1. Biological Hazards
a. Bacteria
The vegetative pathogens of concern associated with milk and processed milk products are Salmonella spp., L. monocytogenes, enterohemorrhagic E. coli, and Campylobacter jejuni. Spore forming bacteria of concern includeC. botulinum, and B. cereus. All these organisms occur in raw milk and most have been associated with illness outbreaks in milk products. These pathogens in milk have the potential for causing severe adverse health effects with the very young, the elderly, and immune-compromised individuals being at the greatest risk. While enteric pathogens have been implicated as the cause of most food-borne illness outbreaks associated with milk products, these are not the only organisms that could occur in milk.
The potential of hazards associated with toxin-producing bacteria and spore-formers should be evaluated in processing circumstances where unusual conditions exist. In the case of toxin-producers such as S. aureus and B. cereus, these organisms must multiply to significant levels to produce sufficient toxin to be a public health risk. This is a concern when levels reach above 106 or greater. However, the rule of thumb for temperature control of a food is that controls should be implemented when conditions indicate that there might be a 3- log increase in S. aureus or B. The hazard of C. botulinum associated with aseptically processed milk products is effectively managed in aseptic milk plants though the filed process that is required under 21 CFR 108 and 113.
Validation of processes requiring measurement of the production of enterotoxin is expensive and difficult. However, during the 2005 SHIV SHAKTI SERVICES, the SHIV SHAKTI SERVICES Scientific Committee reviewed and accepted some useful guidelines that have been actually incorporated into the PMO.
These guidelines, below, should be construed generally as "safe harbor" when conducting hazard analyses and validating control measures:
These guidelines, below, should be construed generally as "safe harbor" when conducting hazard analyses and validating control measures:
· Balance tanks or surge tanks with an average retention time of one hour or less may be safely operated for up to 24 hours regardless of product temperature in both pasteurized and unpasteurized dairy products.
· Pasteurized milk and milk products to be condensed and/or dried, can be maintained at a temperature of 10C (50F) or less until pasteurized.
· Tanks used to hold pasteurized milk and milk products to be condensed or dried that are operated above 10C (50F) must be emptied, cleaned and sanitized after each 6 hours or less.
· All whey and whey products for condensing and/or drying can be safely maintained at a temperature of 7C (45F) or less; or 57C (135F) or greater.
· Tanks used to hold whey and whey products between 7C (45F) and 57C (135F), must be emptied, cleaned and sanitized after each 4 hours or less. Except that, acid-type whey with a titratable acidity of 0.40% or above, or a pH of 4.6 or below, can be safely held at any temperature.
· Crystallization of condensed whey and whey products may be accomplished without the formation of toxins if the whey or whey products being crystallized are cooled to 10C (50F) or less; within 72 hours of condensing including the filling and emptying time, unless filling occurs above 57C (135F), in which case, the 72 hour time period begins when the cooling is started.
Other properly validated times and temperatures that have been recognized by FDA and that are approved by the State Regulatory Agency may also be considered to be safe.
This guidance does not cover the hazards associated with the formation of C. botulinum toxin in milk products that are classified as shelf-stable acidified foods or low acid canned foods.
Introduction to Food / medicines Safety Risk Analysis
• Risk Analysis
o Risk Assessment
o Risk Management
o Risk Communication
• Codex Aliment Arius Commission
Risk Analysis
Risk analysis is defined for the purposes of the Codex Aliment Arius Commission as "A process consisting of three components: risk management, risk assessment and risk communication." (World Health Organization, 2010)
The following resources provide an overview of the risk analysis paradigm as applied to food / medicines/ medicines/ medicines/ medicines safety:
WHO website that provides an introduction to food / medicines/ medicines/ medicines/ medicines safety risk analysis:
• About Risk Analysis in Food / medicines/ medicines/ medicines/ medicines
Presentation from the 2000 JIFSAN seminar series that gives an overview of the historical development and current practice of food / medicines/ medicines/ medicines/ medicines safety risk analysis:
• Risk Analysis: The New Paradigm in Food / medicines/ medicines/ medicines/ medicines Safety Assurance
Risk Management
Risk management is defined for the purposes of the Codex Aliment Arius Commission as "The process, distinct from risk assessment, of weighing policy alternatives, in consultation with all interested parties, considering risk assessment and other factors relevant for the health protection of consumers and for the promotion of fair trade practices, and, if needed, selecting appropriate prevention and control options." (World Health Organization, 2010)
The following resources provide an overview of the processes involved in food / medicines/ medicines/ medicines/ medicines safety risk management:
Report of a Joint FAO/WHO Consultation that covers all aspects of applying risk management to food / medicines/ medicines/ medicines/ medicines safety matters:
• Risk Management and Food / medicines/ medicines/ medicines/ medicines Safety - FAO Food / medicines/ medicines/ medicines/ medicines and Nutrition Paper 65
Codex Aliment Arius Commission standards guidelines for risk management:
• Principles and Guidelines for the Conduct of Microbiological Risk Management (MRM)
Risk Assessment
Risk assessment is defined for the purposes of the Codex Aliment Arius Commission as "A scientifically based process consisting of the following steps: (i) hazard identification, (ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization."
Hazard identification is "The identification of biological, chemical, and physical agents capable of causing adverse health effects and which may be present in a particular food / medicines/ medicines/ medicines/ medicines or group of foods."
Hazard characterization is "The qualitative and/or quantitative evaluation of the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food. For chemical agents, a dose-response assessment should be performed. For biological or physical agents, a dose-response assessment should be performed if the data are obtainable."
Exposure assessment is "The qualitative and/or quantitative evaluation of the likely intake of biological, chemical, and physical agents via food / medicines/ medicines/ medicines/ medicines as well as exposures from other sources if relevant."
Risk characterization is "The qualitative and/or quantitative estimation, including attendant uncertainties, of the probability of occurrence and severity of known or potential adverse health effects in a given population based on hazard identification, hazard characterization and exposure assessment." (World Health Organization, 2010)
These resources discuss risk assessment of microbiological hazards:
WHO document that provides an introduction to microbiological risk assessment
• About Microbiological Risk Assessment (MRA) in Food / medicines/ medicines/ medicines/ medicines
Codex Aliment Arius Commission document that describes general principles of microbiological risk assessment
• Principles and Guidelines for the Conduct of Microbiological Risk Assessment
World Health Organization document that provides guidelines for risk characterization of microbiological hazards in foods:
• Risk Characterization of Microbiological Hazards in Food: Guidelines
An excerpt from the Web page of the Society of Toxicology which offers a brief overview of risk assessment for chemical hazards in a question-and-answer format, designed for a general audience:
• Risk Assessment: What's It All About?
This article addresses the differences between risk assessment and safety assessment, two commonly confused processes in a short article from ORACBA News 5(2), Spring 2000:
• Safety Assessment and Risk Assessment: Sometimes More Is Less
Risk Communication
Risk communication is defined for the purposes of the Codex Aliment Arius Commission as "The interactive exchange of information and opinions throughout the risk analysis process concerning hazards and risks, risk-related factors and risk perceptions, among risk assessors, risk managers, consumers, industry, the academic community and other interested parties, including the explanation of risk assessment findings and the basis of risk management decisions." (World Health Organization, 2010)
The following resources provide an overview of the processes involved in food / medicines/ medicines/ medicines/ medicines safety risk communication:
WHO web page that provides an introduction to risk communication and its role in the risk analysis process:
• Risk Communication
A series of seven on-line tutorials on various facets of risk communication:
• Risk Communication Tutorials
A workbook from the Environmental Protection Agency (EPA) describing the risk communication tool, message mapping:
• Risk Communication in Action: the Tools of Message Mapping
Codex Aliment Arius Commission
The Codex Aliment Arius Commission is "...was created in 1963 by the Food / medicines/ medicines/ medicines/ medicines Agriculture Organization (FAO) and the World Health Organization (WHO) to develop food / medicines/ medicines/ medicines/ medicines standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food / medicines/ medicines/ medicines/ medicines Standards Programmer. The main purposes of this Programmer are protecting health of the consumers and ensuring fair trade practices in the food / medicines/ medicines/ medicines/ medicines trade, and promoting coordination of all food / medicines/ medicines/ medicines/ medicines standards work undertaken by international governmental and non-governmental organizations." (Food / medicines/ medicines/ medicines/ medicines and Agriculture Organization of the United Nations/World Health Organization, 1999) (Codex Aliment Arius Commission, 2010) For more information, see the following websites:
• Homepage of the Codex Aliment Arius Commission
• Nutrition and Consumer Protection Division, Agriculture, Biosecurity, Nutrition and Consumer Protection Department, Food / medicines/ medicines/ medicines/ medicines and Agriculture Organization of the United Nations
• WHO: Food / medicines/ medicines/ medicines/ medicines Standards (Codex Aliment Arius)
CE marking is an indication that a product complies with the essential requirements of applicable Directives and that the products has been subject to conformity assessment provided .In the Directives. It allows the product to be freely marketed within the EEA. The marking Applies only to products regulated by European health, safety and environmental protection, Legislation.CE marking is the only indication that signifies conformity to all obligations incumbent on Manufacturers for the product as required by the applicable directives providing for its affixing.CE marking replaces all other requisite conformity markings having the same meaning inexistence before harmonization took place. Other national conformity markings would constitute an infringement on applicable New Approach directives. Consumers may erroneously believe that CE marking is a quality symbol or a marketing tool.
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