PHILIPPINE NATIONAL STANDARD  PNS/BAFS xxx:2017  
Working Principles for Risk Analysis for Food Safety Application by Governments  
 
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 1 Scope  1 
 2 
This standard is intended to provide guidance to the responsible competent authority 3 
for risk assessment, risk management and risk communication with regard to food 4 
related risks  to human health.  5 
 6 
2 Normative references  7 
 8 
The following referenced documents are indispensable for the application of this 9 
document. For dated references, only the edition cited applies. For undated references, 10 
the latest edition of the referenced document (including any amendments) applies.  11 
 12 
CAC/GL 62 -2007, Working Principles for Risk Analysis for Food Safety for Application by 13 
Governments  14 
 15 
3 Terms and definitions  16 
 17 
For the purposes of this document, the following terms and definitions apply:  18 
 19 
3.1  20 
exposure assessment  21 
qualitative and/or quantitative evaluation of the likely intake of biological, chemical, 22 
and physical agents via food as well as exposures from other sources if relevant  23 
 24 
3.2  25 
hazard  26 
biological, chemical and/ or physical agent in, or condition of, fo od with the potential to 27 
cause an adverse health effect  28 
 29 
3.3  30 
hazard characterization  31 
qualitative and/or quantitative evaluation of the nature of the adverse health effects 32 
associated with biological, chemical and physical agents which may be present in food. 33 
For chemical agents, a dose -response assessment should be performed. For biological 34 
or physical agents, a dose -response assessment should be performed if the data are 35 
obtainable  36 
 37 
3.4  38 
hazard identification  39 
identification of biological, chemical, and physical a gents capable of causing adverse 40 
health effects and which may be present in a particular food or group of foods  41 
 42 
3.5 43 
responsible competent authority  44 
refers to the regulatory agency responsible for the implementation of official food 45 
control system to ensur e public health and safety across the food supply chain  46 
 47 
 48 
3.6 49 PHILIPPINE NATIONAL STANDARD  PNS/BAFS xxx:2017  
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 risk  50 
function of the probability of an adverse health effect and the severity of that effect, 51 
consequential to a hazard(s) in food  52 
 53 
 54 
3.7 55 
risk analysis  56 
process consisting of three components : risk assessment, risk management and risk 57 
communication  58 
 59 
3.8 60 
risk assessment  61 
scientifically based process consisting of the following steps: (i) hazard identification, 62 
(ii) hazard characterization, (iii) exposure assessment, and (iv) risk characterization  63 
 64 
3.9 65 
risk assessment policy  66 
documented guidelines on the choice of options and associated judgements for their 67 
application at appropriate decision points in the risk assessment such that the scientific 68 
integrity of the process is maintained  69 
 70 
3.10  71 
risk char acterization  72 
qualitative and/or quantitative estimation, including attendant uncertainties, of the 73 
probability of occurrence and severity of known or potential adverse health effects in a 74 
given population based on hazard identification, hazard characteriza tion and exposure 75 
assessment  76 
 77 
3.11  78 
risk communication  79 
interactive exchange of information and opinions throughout the risk analysis process 80 
concerning risk, risk -related factors and risk perceptions, among risk assessors, risk 81 
managers, consumers, industry , the academic community and other interested parties, 82 
including the explanation of risk assessment findings and the basis of risk management 83 
decisions  84 
 85 
3.12  86 
risk estimate  87 
quantitative estimation of risk resulting from risk characterization  88 
 89 
3.13  90 
risk management  91 
process, distinct from risk assessment, of weighing policy alternatives, in consultation 92 
with all interested parties, considering risk assessment and other factors relevant for 93 
the health protection of consumers and for the promotion of fair tra de practices, and, if 94 
needed, selecting appropriate prevention and control options  95 
 96 
3.14  97 
risk profile  98 PHILIPPINE NATIONAL STANDARD  PNS/BAFS xxx:2017  
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 description of the food safety problem and its context  99 
 100 
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4 General aspects  103 
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4.1 The overall objective of risk analysis applied to food safety is to ensure human 105 
health protection.  106 
4.2 These principles apply equally to issues of national food control and food trade 107 
situations and should be applied consistently and in a non -discriminatory  108 
manner.  109 
4.3 To the extent possible, the application of risk analysis should be established as 110 
an integral part of a national food safety system.  111 
 112 
4.4 Implementation of risk management decisions at the national level should be 113 
supported by an adequately functioning food c ontrol system/program.  114 
4.5 Risk analysis should be : applied consistently; open, transparent and 115 
documented; and evaluated and reviewed as appropriate in the light of newly 116 
generated scientific data.  117 
4.6 The risk analysis should follow a structured approach compris ing the three 118 
distinct but closely linked components of risk analysis (risk assessment, risk 119 
management and risk communication) as defined by the Codex Alimentarius 120 
Commission , each component being integral to the overall risk analysis.  121 
4.7 The three component s of risk analysis should be documented fully and 122 
systematically in a transparent manner. While respecting legitimate concerns to 123 
preserve confidentiality, documentation should be accessible to all interested 124 
parties  (risk assessors, risk managers, consume rs, industry, the academic 125 
community and, as appropriate, other relevant parties and their representative 126 
organizations) . 127 
4.8 Effective communication and consultation with all interested parties should be 128 
ensured throughout the risk analysis.  129 
4.9 The three components of risk analysis should be applied within an overarching 130 
framework for management of food related risks to human health.  131 
4.10 There should be a functional separation of risk a ssessment and risk management 132 
to the degree practicable, in order to ensure  the scientific integrity of the risk 133 
assessment, to avoid confusion over the functions to be performed by risk 134 
assessors and risk managers and to reduce any conflict of interest.  135 
However, it is recognized that risk analysis is an iterative process, and 136 
interaction between risk managers and risk assessors is essential for practical 137 
application.  138 PHILIPPINE NATIONAL STANDARD  PNS/BAFS xxx:2017  
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 4.11 Precaution is an inherent element of risk analysis. Many sources of uncertainty 139 
exist in the process of risk assessment and risk management of food related 140 
hazards t o human health. The degree of uncertainty and variability in the 141 
available scientific information should be explicitly considered in the risk 142 
analysis. The assumptions used for the risk assessment and the risk management 143 
options selected should reflect the  degree of uncertainty and the characteristics 144 
of the hazard.  145 
4.12 The responsible competent authority  should take into account relevant guidance 146 
and information obtained from risk analysis activities pertaining to human 147 
health protection conducted by Codex, FA O, WHO and other relevant 148 
international intergovernmental organizations, including OIE and IPPC.  149 
4.13 With the support of international organizations where appropriate, the 150 
responsible competent authority should design and/or apply appropriate 151 
training, informa tion and capacity building programs that are aimed to achieve 152 
the effective application of risk analysis principles and techniques in their food 153 
control systems.  154 
4.14 The responsible competent authority should share information and experiences 155 
on risk analysis with relevant international organizations , other national 156 
governments (e.g. at the regional level through FAO/WHO Regional Coordinating 157 
Committees) to promote and facilitate a broader and, where appropriate, more 158 
consistent, application or risk analysis.  159 
5 Risk assessment policy  160 
5.1 Determination of risk assessment policy should be included as a specific 161 
component of risk management.  162 
5.2 Risk assessment policy should be established by risk managers in advance of risk 163 
assessment, in consultation with risk assessors and all other interested parties. 164 
This procedure aims at ensuring that the risk assessment is systematic, 165 
complete, unbiased and transparent.  166 
5.3 The mandate given by risk managers to risk assessors should be as clear as 167 
possible.  168 
5.4 When necessary, risk managers  should ask risk assessors to evaluate the 169 
potential changes in risk resulting from different risk management options.  170 
6 Risk assessment  171 
6.1 Each risk assessment should be fit for its intended purpose.  172 
6.2 The scope and purpose of the risk assessment being carried  out should be clearly 173 
stated and in accordance with risk assessment policy. The output form and 174 
possible alternative outputs of the risk assessment should be defined . 175 PHILIPPINE NATIONAL STANDARD  PNS/BAFS xxx:2017  
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 6.3 Experts involved in risk assessment including government officials and experts 176 
from outs ide government should be objective in their scientific work and not be 177 
subject to any conflict of interest that may compromise the integrity of the 178 
assessment. Information on the identities of these experts, their individual  179 
expertise and their professiona l experience should be publicly available, subject 180 
to national considerations. These experts should be selected in a transparent 181 
manner on the basis  of their expertise and their independence with regard to the 182 
interests involved, including disclosure of co nflicts of interest in connection with 183 
risk assessment.  184 
6.4 Risk assessment should incorporate the four steps of risk assessment, i.e. hazard 185 
identification, hazard characterization, exposure assessment and risk 186 
characterization.  187 
6.5 Risk assessment should be base d on scientific data most relevant to the national 188 
context. It should use available quantitative information to the greatest extent 189 
possible. Risk assessment may also take into account qualitative information.  190 
6.6 Risk assessment should take into account relev ant production, storage and 191 
handling practices used throughout  the food chain including traditional 192 
practices, methods of analysis, sampling and inspection and the prevalence of 193 
specific adverse health effects.  194 
6.7 Constraints, uncertainties and assumptions ha ving an impact on the risk 195 
assessment should be explicitly considered at each step in the risk assessment 196 
and documented in a transparent manner. Expression of uncertainty or 197 
variability in risk estimates may be qualitative or quantitative, but should be 198 
quantified to the extent that is scientifically achievable.  199 
6.8 Risk assessments should be based on rea listic exposure scenarios, with 200 
consideration of different situations being defined by risk assessment policy. 201 
They should include consideration of susceptib le and high -risk population 202 
groups. Acute, chronic (including long -term), cumulative and/or combined 203 
adverse health effects should be taken into account in carrying out risk 204 
assessment, where relevant.  205 
 206 
6.9 The report of the risk assessment should indicate any  constraints, uncertainties, 207 
assumptions and their impact on the risk assessment. Minority opinions should 208 
also be recorded. The responsibility for resolving the impact of uncertainty on 209 
the risk management decision lies with the risk manager, not the risk  assessors.  210 
6.10 The conclusion of the risk assessment including a risk estimate, if available, 211 
should be presented in a readily understandable and useful form to risk 212 
managers and made available to other risk assessors and interested parties so 213 
that they can r eview the assessment.  214 
7 Risk management  215 
7.1 The responsible competent authority  decisions on risk management, including 216 
sanitary measures taken, should have as their primary objective the protection of 217 PHILIPPINE NATIONAL STANDARD  PNS/BAFS xxx:2017  
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 the health of consumers. Unjustified differences in the me asures selected to 218 
address similar risks in different situations should be avoided.  219 
7.2 Risk management should follow a structured approach including preliminary 220 
risk management activities  (identification of a food safety problem; 221 
establishment of a risk profi le; ranking of the hazard for risk assessment and risk 222 
management priority; establishment of risk assessment policy for the conduct of 223 
the risk assessment; commissioning of the risk assessment; and consideration of 224 
the result of the risk assessment) , evalu ation of risk management options, 225 
implementation, monitoring and review of the decision taken.  226 
7.3 The decisions should be based on risk assessment, and should be proportionate 227 
to the assessed risk, taking into account, where appropriate, other legitimate 228 
factors relevant for the health protection of consumers and for the promotion of 229 
fair practices in food trade, in accordance with the Criteria for the Consideration 230 
of the Other Factors Referred to in the Second Statement of Principles as they  231 
relate to decisi ons at the national level. The responsible competent authority 232 
should base their sanitary measures on Codex standards and related texts, where 233 
available.  234 
7.4 In achieving agreed outcomes, risk management should take into account 235 
relevant production, storage and handling practices used throughout the food 236 
chain including traditional practices, methods of analysis, sampling and 237 
inspection, feasibility of enforcem ent and compliance, and the prevalence of 238 
specific adverse health effects.  239 
7.5 Risk management should take into account the economic consequences of the 240 
feasibility of risk management options.  241 
7.6 The risk management process should be transparent, consistent and f ully 242 
documented. Decisions on risk management should be documented so as to 243 
facilit ate a wider understanding of the risk management process by all interested 244 
parties.  245 
7.7 The outcome of the preliminary risk management activities and the risk 246 
assessment should be combined with the evaluation of available risk 247 
management options in order to reach a decision on management of the risk.  248 
7.8 Risk management options should be assessed in terms of the scope and purpose 249 
of risk analysis and the level of consumer health prot ection they achieve. The 250 
option of not taking any action should also be considered.  251 
7.9 Risk management should ensure transparency and consistency in the decision - 252 
making process in all cases. Examination of the full range of risk management 253 
options should, as far as possible, take into account an assessment of their 254 
potential advantages and disadvantages. When making a choice among different 255 
risk management options, which are equally effective in protecting the health of 256 
the consumer, national governments shoul d seek and take into consideration the 257 
potential impact of such measures on trade and select measures that are no more 258 
trade -restrictive than necessary.  259 PHILIPPINE NATIONAL STANDARD  PNS/BAFS xxx:2017  
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 7.10 Risk management should be a continuing process that takes into account all 260 
newly generated data in the evaluation and review of risk management options. 261 
The relevance, effectiveness, and impacts of risk management decisions and their 262 
implementation should be regularly monitored and the decisions and/or their 263 
implementation reviewed as necessary.  264 
8 Risk comm unication  265 
8.1 Risk communication should:  266 
8.1.1 promote awareness and understanding of the specific issues under 267 
consideration during the risk analysis;  268 
8.1.2 promote consistency and transparency in formulating risk management 269 
options/recommendations;  270 
8.1.3 provide a sound basis  for understanding the risk management decisions 271 
proposed;  272 
8.1.4 improve the overall effectiveness and efficiency of the risk analysis;  273 
8.1.5 strengthen the working relationships among participants;  274 
8.1.6 foster public understanding of the process, so as to enhance trust an d 275 
confidence in the safety of the food supply;  276 
8.1.7 promote the appropriate involvement of all interested parties;  277 
8.1.8 exchange information in relation to the concerns of interested parties about 278 
the risks associated with food; and  279 
8.1.9 respect the legitimate concern to  preserve confidentiality where applicable.  280 
8.2 Risk analysis should include clear, interactive and d ocumented communication, 281 
among  risk assessors and risk managers and reciprocal communication with all 282 
interested parties in all aspects of the process.  283 
8.3 Risk communication should be more than the dissemination of information. Its 284 
major function should be to ensure that all information and opinion required for 285 
effective risk management is incorporated into the decision making process.  286 
8.4 Risk communication involvin g interested parties should include a transparent 287 
explanation of the risk assessment policy and of the assessment of risk, including 288 
the uncertainty. The decisions taken and the procedures followed to reach them, 289 
including how the uncertainty was dealt wit h, should also be clearly explained. It 290 
should indicate any constraints, uncertainties, assumptions and their impact on 291 
the risk analysis, and minority opinions that had been expressed in the course of 292 
risk assessment (see 6.9).   293 PHILIPPINE NATIONAL STANDARD  PNS/BAFS xxx:2017  
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 Bibliography  294 
Codex Alimentarius Commission. 2013. Codex Alimentarius Commission Procedural 295 
Manual Twenty -first edition . Rome: World Health Organization and Food and 296 
Agriculture Organization of the United Nations.  297