DRAFT RISK ANALYSIS PRINCIPLES APPLIED BY THE
CODEX COMMITTEE ON FOOD ADDITIVES AND CONTAMINANTS
(At Step 8 of the Procedure)
a) This document addresses the respective applications of risk analysis principles by the Codex Committee on Food Additives and Contaminants (CCFAC) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA). For matters which cannot be addressed by JECFA, this document does not preclude the possible consideration of recommendations arising from other internationally recognized expert bodies.
b) CCFAC and JECFA recognize that communication between risk assessors and risk managers is critical to the success of their risk analysis activities.
c) CCFAC and JECFA will continue to develop procedures to enhance communication between the two committees.
d) CCFAC and JECFA will ensure that their contributions to the risk analysis process are fully transparent, thoroughly documented and available in a timely manner to Members.
e) JECFA, in consultation with CCFAC, will continue to explore developing minimum quality criteria for data requirements necessary for JECFA to perform risk assessments. These criteria will be used by CCFAC in preparing its Priority List for JECFA. The JECFA Secretariat will consider whether these minimum quality criteria for data have been met when preparing the provisional agenda for meetings of JECFA.
3. CCFAC
f) CCFAC is primarily responsible for recommending risk management proposals for adoption by the CAC.
g) CCFAC will base its risk management recommendations to the CAC on JECFA’s risk assessments, including safety assessments1, of food additives, naturally occurring toxicants, and contaminants in food.
h) In cases where JECFA has performed a safety assessment and CCFAC or the CAC determines that additional scientific guidance is necessary, CCFAC or CAC may make a more specific request to JECFA to obtain the scientific guidance necessary for a risk management decision.
i) CCFAC’s risk management recommendations to the CAC with respect to food additives shall be guided by the principles described in the Preamble and relevant annexes of the Codex General Standard for Food Additives.
j) CCFAC’s risk management recommendations to the CAC with respect to contaminants and naturally occurring toxicants shall be guided by the principles described in the Preamble and relevant annexes of the Codex General Standard for Contaminants and Naturally Occurring Toxins in Food.
k) CCFAC’s risk management recommendations to the CAC that involve health and safety aspects of food standards will be based on JECFA’s risk assessments and other legitimate factors relevant to the health protection of consumers and for the promotion of fair practices in food trade.
l) CCFAC’s risk management recommendations to the CAC will take into account the relevant uncertainties and safety factors described by JECFA.
m) CCFAC will endorse maximum use levels only for those additives for which 1) JECFA has established specifications of identity and purity and 2) JECFA has completed a safety assessment or has performed a quantitative risk assessment.
n) CCFAC will endorse maximum levels only for those contaminants for which 1) JECFA has completed a safety assessment or has performed a quantitative risk assessment and 2) the level of the contaminant in food can be determined through appropriate sampling plans and analysis methods, as adopted by Codex. CCFAC should take into consideration the analytical capabilities of developing countries unless public health considerations require otherwise.
o) CCFAC will take into account differences in regional and national food consumption patterns and dietary exposure as assessed by JECFA when recommending maximum use levels for additives or maximum levels for contaminants and naturally occurring toxicants in food.
p) Before finalising proposals for maximum levels for contaminants and naturally occurring toxicants, CCFAC shall seek the scientific advice of JECFA about the validity of the analysis and sampling aspects, about the distribution of concentrations of contaminants and naturally occurring toxicants in foods and about other relevant technical and scientific aspects, including dietary exposure, as necessary to provide for a suitable scientific basis for its advice to CCFAC.
q) When establishing its standards, codes of practice, and guidelines, CCFAC will clearly state when it applies any other legitimate factors relevant to the health protection of consumers and for the promotion of fair practices in food trade, in addition to JECFA’s risk assessment, and specify its reasons for doing so.
r) CCFAC’s risk communication with JECFA will include prioritizing substances for JECFA review with the view towards obtaining the best available risk assessment for purposes of elaborating safe conditions of use for food additives and elaborating safe maximum levels or codes of practice for contaminants and naturally occurring toxicants in food.
s) CCFAC will consider the following when preparing its priority list of substances for JECFA review:
• Consumer protection from the point of view of health and prevention of unfair trade practices;
• CCFAC’s Terms of Reference;
• JECFA’s Terms of Reference;
• The Codex Alimentarius Commission’s Medium-Term Plan of Work;
• The quality, quantity, adequacy, and availability of data pertinent to performing a risk assessment;
• The prospect of completing the work in a reasonable period of time;
• The diversity of national legislation and any apparent impediments to international trade;
• The impact on international trade (i.e., magnitude of the problem in international trade); and,
• Work already undertaken by other international organizations;
t) When referring substances to JECFA, the CCFAC will provide background information and clearly explain the reasons for the request when chemicals are nominated for evaluation
u) When referring substances to JECFA, CCFAC may also refer a range of risk management options, with a view toward obtaining JECFA’s guidance on the attendant risks and the likely risk reductions associated with each option.
v) CCFAC will request JECFA to review any methods and guidelines being considered by CCFAC for assessing maximum use levels for additives or maximum levels for contaminants and naturally occurring toxicants. CCFAC will make any such request with a view toward obtaining JECFA’s guidance on the limitations, applicability, and appropriate means for implementation of a method or guideline for CCFAC's work.
w) JECFA is primarily responsible for performing the risk assessments upon which CCFAC and ultimately the CAC base their risk management decisions.
x) JECFA will select scientific experts on the basis of their competence and independence, taking into account geographical representation to ensure that all regions are represented.
y) JECFA will strive to provide CCFAC with science-based risk assessments that include the four components of risk assessment as defined by CAC and safety assessments that can serve as the basis for CCFAC’s risk-management discussions. For contaminants and naturally occurring toxicants, JECFA will determine to the extent possible the risks associated with various levels of intake. Because of the lack of appropriate information, including data in humans, however, this will be possible in only a few cases in the foreseeable future. For additives, JECFA will continue to use its safety assessment process for establishing ADIs.
z) JECFA will strive to provide CCFAC with science-based quantitative risk assessments and safety assessments for food additives, contaminants, and naturally occurring toxicants in a transparent manner.
aa) JECFA will provide CCFAC with information on the applicability and any constraints of the risk assessment to the general population to particular sub-populations and will as far as possible identify potential risks to populations of potentially enhanced vulnerability (e.g., children, women of child-bearing age, the elderly).
bb) JECFA will also strive to provide CCFAC with specifications of identity and purity essential to assessing risk associated with the use of additives.
cc) JECFA will strive to base its risk assessments on global data, including that from developing countries. These data should include epidemiological surveillance data and exposure studies.
dd) JECFA is responsible for evaluating exposure to additives, contaminants, and naturally occurring toxicants.
ee) When evaluating intake of additives or contaminants and naturally occurring toxicants during its risk assessment, JECFA will take into account regional differences in food consumption patterns.
ff) JECFA will provide to CCFAC its scientific views on the validity and the distribution aspects of the available data regarding contaminants and naturally occurring toxicants in foods which have been used for exposure assessments, and will give details on the magnitude of the contribution to the exposure from specific foods as may be relevant for risk management actions or options of CCFAC.
gg) JECFA will communicate to CCFAC the magnitude and source of uncertainties in its risk assessments. When communicating this information, JECFA will provide CCFAC a description of the methodology and procedures by which JECFA estimated any uncertainty in its risk assessment.
hh) JECFA will communicate to CCFAC the basis for all assumptions used in its risk assessments including default assumptions used to account for uncertainties.
ii) JECFA’s risk assessment output to CCFAC is limited to presenting its deliberations and the conclusions of its risk assessments and safety assessments in a complete and transparent manner. JECFA’s communication of its risk assessments should not include the consequences of its analyses on trade or other non-public health consequence. Should JECFA include risk assessments of alternative risk management options, JECFA should ensure that these are consistent with the Working Principles for Risk Analysis for the Application in the Framework of the Codex Alimentarius and Risk Analysis Principles applied by the Codex Committee on Food Additives and Contaminants.
jj) When establishing the agenda for a JECFA meeting, the JECFA Secretariat will work closely with CCFAC to ensure that CCFAC’s risk management priorities are addressed in a timely manner. With respect to food additives, the JECFA Secretariat will normally give first priority to compounds that have been assigned a temporary ADI, or equivalent. Second priority will be normally given to food additives or groups of additives that have previously been evaluated and for which an ADI, or equivalent, has been estimated, and for which new information is available. Third priority will be normally given to food additives that have not been previously evaluated. With respect to contaminants and naturally occurring toxicants, the JECFA Secretariat will give priority to substances that present both a significant risk to public health and are a known or expected problem in international trade
kk) When establishing the agenda for a JECFA meeting, the JECFA Secretariat will give priority to substances that are known or expected problems in international trade or that present an emergency or imminent public health risk.
1 A Safety Assessment is defined as a scientifically-based process consisting of: 1) the determination of a NOEL (No Observed Effect Level) for a chemical, biological, or physical agent from animal feeding studies and other scientific considerations; 2) the subsequent application of safety factors to establish an ADI or tolerable intake; and 3) comparison of the ADI or tolerable intake with probable exposure to the agent (Temporary definition to be modified when JECFA definition will be available).