Competent authorities and their regulations

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Competent Authorities and Their Regulations
Introduction:
According to “Codex Alimentarius Commission” competent authority means “The official
authority charged by or part of the government with the control of food hygiene and the
management of official systems of inspection and certification.”
According to European Union, ‘Competent authority’ means the central authority of a
Member State competent for the organization of official controls or any other authority to
which that competence has been conferred.
Some well recognized competent authorities are
• US-FDA (United States Food and Drug Administration)
• EC (European Commission)
• WTO (World Health Organization)
• GATT (General Agreement on Tariffs and Trades)
• ITC (International Trade Commission)
• BSTI (Bangladesh Standard Testing Institute )
• EU (European Commission)
In many countries competent authorities are part of the government e.g. Ministry of Health,
Ministry of Agriculture. For zoonotic diseases there is often an overlap between agriculture
and health departments.
Food safety legislation
To enable the establishment of food laws and competent authorities, so that they can develop,
establish, implement, maintain and enforce a national food control system.
Food safety legislation should be aimed at the reduction, elimination or avoidance of a risk to
health and be based on the three interconnected components of risk analysis - risk
assessment, risk management, and risk communication to provide a systematic methodology
for the determination of effective, proportionate and targeted measures to protect health.
Working principles for risk analysis for food safety for application
The overall objective of risk analysis applied to food safety is to ensure human health
protection.
 These principles apply equally to issues of national food control and food trade
situations and should be applied consistently and in a nondiscriminatory manner.
 To the extent possible, the application of risk analysis should be established as an
integral part of a national food safety system.
 Implementation of risk management decisions at the national level should be
supported by an adequately functioning food control system/program.

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 Risk analysis should be:
o applied consistently;
o open, transparent and documented; and
o Evaluated and reviewed as appropriate in the light of newly generated
scientific data.
 The three components of risk analysis should be documented fully and systematically
in a transparent manner.
 Effective communication and consultation with all interested parties should be
ensured throughout the risk analysis.
 The three components of risk analysis should be applied within an overarching
framework for management of food related risks to human health.
 There should be a functional separation of risk assessment and risk management to
the degree practicable.
 With the support of international organizations where appropriate, national
governments should design and/or apply appropriate training, information and
capacity building programs that are aimed to achieve the effective application of risk
analysis principles and techniques in their food control systems.
Official control programs
• Purpose of the Guidelines
• Guidance on the legal requirements for national control plans
• National control plans
• General requirements for national control plans
• Strategic objectives of national control plans
• Risk categorization
• Designation of competent authorities
• General organization and management
• Control systems and coordination of activities
• Delegation to control bodies
• Compliance with operational criteria
• Training of staff performing official controls
• Documented procedures
• Operational contingency plans
• Organization of cooperation and mutual assistance
• Adjustment of national control plans
Strategic objectives
Taking into account that the main objective of a food safety system is to protect public health
through the effective enforcement of food law, it is essential to develop appropriate
objectives and strategies to achieve that purpose. Those objectives and strategies, which may
involve the concentration or prioritization of official controls or the allocation of resources on
certain activities or at certain stages of the production chain should form the basis of a
national control plan.

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Official control operational procedures
Programs and training manuals should be developed and implemented to ensure consistent
application of requirements. Documentation for competent authorities should include:
An organizational chart of the official control system;
• Roles of each level in the hierarchy (including other relevant jurisdictions i.e.,
State, Provincial);
• Job functions and qualifications as appropriate;
• Operating procedures including methods of inspection and control, sampling, and
testing;
• Relevant legislation and requirements;
• Arrangements for coordination with key officials in relevant ministries and private
sector organizations;
• Relevant information about food contamination and food control;
• Procedures for conducting food recalls and investigations; and
• Relevant information on staff training.
• Programs and training manuals should be developed and implemented to ensure
uniform application
Competent authority personnel:
National food control systems should have, or have access to, a sufficient number of qualified
personnel as appropriate in areas such as: food science and technology, chemistry,
biochemistry, microbiology, veterinary science, human medicine, epidemiology, agronomic
engineering, quality assurance, audit and law. Personnel should be capable and appropriately
trained in the operation of food inspection and control systems. They should have a status
which ensures their impartiality and have no direct commercial interest in the products or
establishments being inspected or certified.
Inspection is the examination of food or systems for control of food, raw materials,
processing and distribution, including in-process and finished product testing, in order to
verify that they conform to requirements.
Audit is a systematic and functionally independent examination to determine whether
activities and related results comply with planned objectives.
Official controls of fish and fishery products
The elements of a control program should include, as appropriate:
 inspection;
 sampling and analysis;
 checks on hygiene, including personal cleanliness and clothing;
 examination of written and other records;

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 examination of the results of any verification systems operated by the
establishment;
 audit of establishments by the national competent authority;
 national audit and verification of the control programme;
 administrative procedures should be in place to ensure that controls by the
inspection system are carried out;
 regularly in proportion to risk;
 where non-compliance is suspected or identified;
 in a co-ordinated manner between different authorities, if several exist.
Controls should cover, as appropriate:
- establishments, installations, means of transport, equipment and material;
- raw materials, ingredients, technological aids and other products used for the
preparation and production of foodstuffs;
- semi-finished and finished products;
- materials and objects intended to come into contact with foodstuffs;
- cleaning and maintenance products and processes, and pesticides;
- processes used for the manufacture or processing of foodstuffs;
- the application and integrity of health, grading and certification marks;
- preserving methods;
- labeling integrity and claims.
- The elements of the control programme should be formally documented including
methods and techniques.
Risk-based official controls over fishery product:
There are two main components to the risk that food businesses may present to public health:
• Intrinsic risks
 Type of fish and method of handling
 Method of processing
 Consumers at risk
• FBO-related risks
 Level of (current) compliance
 Confidence in management/control procedures
Official certification
Food inspection and certification systems should be used wherever appropriate to ensure
those foods, and their production systems, meet requirements in order to protect consumers
against food-borne hazards and deceptive marketing practices and to facilitate trade on the
basis of accurate product description.

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US-FDA (United States Food and Drug Administration)
Food Laws Suggested by FDA:
1. Food laws will not guarantee that food is safe; it is too expensive to guarantee that all food
is safe for consumption. The less expensive approach, but still politically and socially
accepted, is for food laws to reduce the risk of unsafe food.
 To understand the risk of unsafe food and to manage that risk requires an application
of science, such as biology, microbiology, chemistry, pathology, engineering, etc.
 Despite common expectations for all foods and all food businesses, each type of food
needs specific, unique or individualized production, processing and handling practices
to reduce the risk that the food is rendered unsafe.
 Strategies to reduce the risk of unsafe food must be developed and implemented at
each step in the food system.
2. U.S. food law has defined the food industry into sectors:
 consumers,
 retail and food service sector (e.g., grocery stores, restaurants, cafeterias),
 processing sector (e.g., food businesses that manufacture/process, transport and store
food products),
 production sector which produces agricultural commodities (e.g., farms, ranches,
orchards, vineyards, feedlots), and
 the production input sector that provides agricultural producers with animal drugs,
animal feed, pesticides, and biotechnology.
3. Government oversight of the sectors can be summarized as follows; note that the
government oversight strategy varies by sector and the oversight strategies are changing.
 Consumers -- the primary strategies to advance food safety are 1) educate the
consumers about food safety (and nutrition) and 2) provide information so consumers
can make informed decisions.
 Retail and food service sector -- primarily regulated by state law and municipal health
codes with increasing guidance from the federal level via the Food and Drug
Administration (e.g., the Food Code).
 Processing sector -- primarily regulated by U.S. federal law since the early 1900s in
coordination with state law and municipal health codes. The primary U.S. federal
agencies are 1) the U.S. Food and Drug Administration (FDA) and 2) the Food Safety
Inspection Service (FSIS) in the U.S. Department of Agriculture (USDA). Hazard
Analysis and Critical Control Point (HACCP) is emerging as the dominant strategy.
The recently defined Food Safety Plan is based on the principles of HACCP.
4. Federal law dominates the regulation of food safety in the United States but there is close
interaction with state and local authorities, plus an expanding role and impact of international
food standards.

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 The major prohibitions in food safety laws are the sale
of adulterated or misbranded food products; adulterated and misbranded have broad
definitions and address a number of food safety concerns.
 Firms also are prohibited from selling food products if they do not appropriately
document where and how food is handled; for example, registering the food
facility and developing/implementing a Food Safety/HACCP plan.
5. It is the task or burden of the food business to establish that the food is NOT adulterated or
misbranded. It is not the government's responsibility to establish that food is adulterated or
misbranded.
6. Food must be in compliance with the laws of the jurisdiction where the food is located.
7. The two U.S. federal agencies with primary responsibility for food safety in the United
States are
 The Food and Drug Administration (FDA) in the Department of Health and Human
Services, and
 The Food Safety and Inspection Service (FSIS) in the U.S. Department of Agriculture
(USDA).
 The Environmental Protection Agency also has an expanding role (EPA's discussion
of the Food Quality Protection Act). In addition, the Food Safety Office in the Centers
for Disease Control and Prevention (CDC) provides information about food-borne
illnesses and responds to outbreaks of food-borne illnesses.
9. Decisions about what to eat will be made by the consumer, not a government authority; but
the law requires that information about the food product be available so consumers can make
an informed choice.
10. Government inspection of the food industry continues to be an important strategy, but one
must understand the recent and ongoing shift of responsibility to the firms with the adoption
of Hazardous Analysis and Critical Control Points (HACCP) plan requirements.
Basic strategies to protect against misbranded fishery product
 Mandate and monitor labeling; assure the labeling complies with labeling regulations
 Monitor advertising and promotional claims; assure the claims align with regulations
pertaining to making claims about the fishery product
 Assure labels are not damaged or removed
 Assure information on labels and other consumer communications are not misleading
Other laws that prohibit adulterated and misbranded fishery product
For the purposes of this title food shall be deemed to be adulterated:
1. If any substance has been mixed and packed with it so as to reduce, lower, or
injuriously affect its quality or strength;

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2. If any substance has been substituted wholly or in part for it;
3. If any valuable constituent thereof has been wholly or in part abstracted;
4. If it be mixed, colored, powdered, coated, or stained in a manner whereby damage or
inferiority is concealed;
5. If it contains any poisonous or otherwise deleterious ingredient, added or natural, this
may render it injurious to health.
6. If in the manufacture, sale, distribution, transportation, or in the offering or exposing
for sale, distribution, or transportation, it is not at all times securely protected from all
filth, flies, dust, contamination, or other unclean, unhealthful, or insanitary conditions.
Application of HACCP
Step #1 Assemble a HACCP Team
 A commitment from management.
 Multidisciplinary membership.
 Know the manufacturing process and the products
 Know how to take corrective action.
 Understand the HACCP principles.
Step #2 Processing and Distribution of Foods
 A separate HACCP is needed for each product.
 What method will be used for distributing the product?
 Is the product refrigerated, frozen or shelf-stable?
 What safety hazard or quality issue are associated with this food product?
Step #3 Intended Use and Consumers
 What impact will the product have on the general public?
 Are you targeting a specific segment of the market? Particular consumers? Are you
targeting a wholesale or retail market?
 What are the ingredients? Do any ingredient pose a food safety risk?
 Does the food offer specific characteristics, such as, a low fat products
Step #4 Develop a Flow Diagram
 The diagram or flow chart must cover all steps of the manufacturing process.
 It is not an engineering drawing.
 Verify the accuracy and completeness of the flow diagram.
 Take the diagram to the production floor to assure/verify its accuracy.
Step #5 Conduct a Hazard Analysis
 Are you concerned about microbiological, chemical or physical hazards (again,
this list is expanding)?
 Identify steps in the manufacturing process where a hazard can happen.
 Consider risk (probability) of the hazard and severity if the hazard occurs.

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 Remember -- hazard is limited to safety; it does not focus on quality issues (even
though they may be related).
 Identify preventative measures that can be applied.
Step #6 Critical Control Points (CCP)
 CCP -- any place in the manufacturing and distribution process where control can be
applied to prevent a hazard.
 GMPs can and should control many hazards.
 A CCP for one product many not be a CCP for another product.
Step #7 Critical Limits (CL)
 Limit that must be met to insure safety of the product.
 Exceeding the CL means a health hazard exists.
 CLs can be derived from regulatory standards (e.g., dairy), guidelines, studies,
experts, etc.
 Examples of CLs: temperatures (for some products it may be what is too high and for
other products it may be what is too low), time, pH, residues, kind and count of
bacteria.
Step #8 Monitoring/Inspection
 Planned sequence of observations or measurements.
 Must control CCP’s
 Must be effective.
 Monitoring intervals must be reliable.
 Must be rapid, no lengthy analysis.
 Adequate plan to see that the monitoring is carried out.
Step #9 Corrective Actions
 Specify procedures to be taken when deviations occur.
 Corrective actions must be documented.
 Eliminate actual or potential hazards.
 Be prepared to put products on hold if a problem is identified.
 Make changes to prevent future occurrence.
Step #10 Records
 Must include every part of the HACCP program, from team membership through all
actions -- steps #1 – 12
Step #11 Verification
 Consists of methods, procedures or tests used in monitoring compliance.
 CCP’s are under control
 Necessary changes have been made.

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 All records are complete.
 Sample analysis to verify.
 Training and knowledge.
Step #12 Evaluation and Revision
 At least an annual review.
 Anytime manufacturing process is changed or products are changed.
 Anytime new raw materials or sources are used.
 Anytime formulation is changed.
 Anytime new equipment is installed; in some cases, even adjusting the performance
of the equipment may necessitate are review of the HACCP..
 Anytime there is a change in personnel or shifts.
 Anytime there is a changes in storage or distribution.
HACCP and the Food Safety Modernization Act
Food Safety Plans must address the following points:
 Identify and implement preventive controls, including at critical control points, to
provide assurances that hazards identified in the hazard analysis will be significantly
minimized or prevented; and the food manufactured, processed, packed, or held by
such facility will not be adulterated or misbranded.
 Monitor the effectiveness of the implemented preventive controls to assure that the
identified hazards are significantly minimized or prevented.
 Establish procedures to ensure that if the implemented preventive controls are not
properly implemented or are found to be ineffective (1) appropriate action is taken to
reduce the likelihood of recurrence of the implementation failure; (2) all affected food
is evaluated for safety; and (3) all affected food is prevented from entering into
commerce if the business cannot ensure that the affected food is not adulterated or
misbranded.
 Verify that (1) the preventive controls implemented are adequate to control the
hazards identified; (2) the business is monitoring as required by law; (3) the
business is making appropriate decisions about corrective actions taken; (4) the
implemented preventive controls are effectively and significantly minimizing or
preventing the occurrence of identified hazards, including through the use of
environmental and product testing programs and other appropriate means; and (5)
there is documented, periodic re-analysis of the plan to ensure that the plan is still
relevant to the raw materials, conditions and processes in the facility, and new and
emerging threats.
 Maintain, for not less than two years, records documenting the monitoring of the
implemented preventive controls, instances of nonconformance material to food
safety, the results of testing and other appropriate means of verification, instances
when corrective actions were implemented, and the efficacy of preventive controls
and corrective actions.

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 Prepare a written plan that documents and describes the procedures used by the
business to comply with these requirements, including analyzing the hazards and
identifying the adopted preventive controls to address those hazards. Such written
plan, together with the documentation, shall be made promptly available to a duly
authorized representative of the FDA upon oral or written request.
 Conduct a re-analysis whenever a significant change is made in the activities
conducted at a facility if the change creates a reasonable potential for a new hazard or
a significant increase in a previously identified hazard, or not less frequently than
once every three years, whichever is earlier. Such re-analysis shall be completed and
additional preventive controls needed to address the hazard identified, if any, shall be
implemented before the change in activities at the facility is operative.
EU import conditions for seafood and other fishery products
The European Union is by far the world’s biggest importer of fish, seafood and aquaculture
products. Import rules for these products are harmonized, meaning that the same rules apply
in all EU countries. For non-EU countries the European Commission is the negotiating
partner that defines import conditions and certification requirements.
General Rules for Fishery Products
Imports of fishery products into the European Union are subject to official certification,
which is based on the recognition of the competent authority of the non-EU country by the
European Commission. This formal recognition of the reliability of the competent authority is
a pre-requisite for the country to be eligible and authorized to export to the European Union.
Public authorities with the necessary legal powers and resources must ensure credible
inspection and controls throughout the production chain, which cover all relevant aspects of
hygiene, public health and, in the case of aquaculture products, also animal health.
Specific Key Elements
For all fishery products, countries of origin must be on a positive list of eligible countries for
the relevant product. The eligibility criteria are:
• Exporting countries must have a competent authority which is responsible for
official controls throughout the production chain. The Authorities must be
empowered, structured and resourced to implement effective inspection and
guarantee credible public health and animal health attestations in the certificate to
accompany fishery products that are destined for the EU.
• Live fish, their eggs and gametes intended for breeding and live bivalve molluscs
must fulfill the relevant animal health standards. This requires that the veterinary
services must ensure effective enforcement of all necessary health controls and
monitoring programmes.
• The national authorities must also guarantee that the relevant hygiene and public
health requirements are met. The hygiene legislation contains specific

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requirements on the structure of vessels, landing sites, processing establishments
and on operational processes, freezing and storage.
• Specific conditions apply for imports of live or processed bivalve molluscs (e.g.
mussels and clams), echinoderms (e.g. sea urchins) or marine gastropods (e.g. sea-
snails and conchs).
• In the case of aquaculture products, a control plan on heavy metals, contaminants,
residues of pesticides and veterinary drugs must be in place to verify compliance
with EU requirements.
• A suitable control plan must be designed by the competent authority and
submitted to the European Commission for initial approval and yearly renewal.
• Imports are only authorized from approved vessels and establishments (e.g.
processing plants, freezer or factory vessels, cold stores), which have been
inspected by the competent authority of the exporting country and found to meet
EU requirements.
The formal steps towards approval for imports
The EU has designed a procedure for the evaluation of the eligibility of third countries for
exporting fishery products to the EU.
1. The national authority of a third country must submit a formal request to the
Directorate-General for Health and Consumer Protection of the European
Commission to export fish, fishery products or bivalve mollusks to the EU.
2. The Directorate-General for Health and Consumer Protection sends out a
questionnaire which should be completed and returned. Information on relevant
legislation, competent authorities, hygiene and many other elements are requested.
3. For aquaculture products, a residue monitoring plan of the exporting country must
also be submitted and approved at this stage.
4. After the evaluation of the paper submission, an inspection by the Food and
Veterinary Office may be carried out to assess the situation on the spot. Such an
inspection is mandatory for high-risk products like shellfish.
5. Based on the results of the evaluation / inspection, and the guarantees given by the
exporting country, the Directorate-General for Health and Consumer Protection
proposes the listing of the country, the specific conditions under which imports from
that country will be authorized and the list of approved establishments in the country.
These are then discussed with representatives of all EU Member States.
6. If the Member States have a favorable opinion on the proposal, the European
Commission adopts the specific import conditions.
Conclusion:
A common of Regulation is that, to fulfill their roles effectively, competent authorities must
have access to relevant information, clear communication links both with other competent
authorities and with those organizations fulfilling related roles, and the legal powers and
resources to fulfill their established roles.

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References:
https://en.wikipedia.org/wiki/Competent_authority
http://www.clientearth.org/reports/eutr-vpa-competent-authorities.pdf
https://www.ag.ndsu.edu/foodlaw/safe-408-608/foodprocessingregulation
https://www.ag.ndsu.edu/foodlaw/overview/riskanalysis
http://ec.europa.eu/food/index_en.htm
http://ec.europa.eu/food/animal/animalproducts/index_en.htm
http://ec.europa.eu/food/international/trade/interpretation_imports.pdf
http://exporthelp.europa.eu/index_en.html