Global Harmonization of Food
Ingredient Specifications and the
Importance of Codex Alimentarius
David R. Schoneker
Director of Global Regulatory Affairs
Colorcon
dschoneker@colorcon.com
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
The Need for Harmonization of Food
and Color Additive Specifications
 Food regulations in many countries provide lists of approved
food and color additives for various food categories, acceptable
levels of use and specifications for these materials
 These lists, food categories and specifications are extremely
non-harmonized around the world which makes it very difficult
for international trade of many food products
 Major developed countries such as the U.S. Europe and Japan
have had detailed food and color additive regulatory systems in
place for many years which has led to significant nonharmonized standards
 Currently, many developing countries are in the process of
improving their regulations related to food and color additives in
a non-harmonized manner which is increasing the problems
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Codex Committee on Food Additives (CCFA)
 Global food standards setting committee
 Goal: harmonized food standards
 CCFA is developing a General Standard for Food
Additives (GSFA) that lists food additives
reviewed and assigned an Acceptable Daily
Intake (ADI) (either numerical or "not specified")
by JECFA.
 The GSFA provides a list of food categories for
which an additive may be used and the maximum
level of use for each category.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
JECFA
 Joint FAO/WHO Expert Committee on Food
Additives
 International expert scientific committee that is
administered jointly by the Food and Agriculture
Organization of the United Nations (FAO) and the
World Health Organization (WHO)
 Global body that performs toxicological
evaluations (risk assessment and exposure
assessment)
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
JECFA
 Meet once a year to review food additive safety
data submitted
 Works in conjunction with Codex Committee on
Food Additives (CCFA)
 Has evaluated more than 2,500 food additives
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
General Standard for Food Additives (GFSA)
 Has 16 food categories, most with subcategories
(hierarchical), that lists food additives and
maximum level allowed for use in each food
category
 Organized in three tables:
— Table 1: Organized by Food Additive
— Table 2: Organized by Food Category
— Table 3: Additives for which an ADI of “non-specified”
(previously called ADI “not-limited”) has been assigned;
additives permitted for use at GMP’s, except for food
categories listed in the Annex
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
General Standard for Food Additives
Initial Charge to the Committee 1991
 Elaborate a GSFA that includes all foods
 Develop the GSFA
1. CCFA should agree to accept science-based JECFA safety
evaluations
2. CCFA should recognize variability of technological need
among different nations
3. CCFA should not rely on individual government prohibitions
on additives in specified foods, yet instead should rely more
heavily on informative labeling
4. CCFA members should rely on the GSFA as the single
authoritative source on food additives
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
GSFA – Food Additive Provisions
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Note 161
 Note 161 undermines:
— scientific base of Codex and
— foundation of Codex as an international standard setting organization
— and is inconsistent with WTO SPS agreement regarding scientific
justification…“national governments can adopt more restrictive standards
than those of Codex if there is scientific justification” and “Codex
standards are voluntary and national governments may introduce a higher
level of protection when justified”
 Codex “STATEMENTS OF PRINCIPLE CONCERNING THE ROLE
OF SCIENCE IN THE CODEX DECISION-MAKING PROCESS AND
THE EXTENT TO WHICH OTHER FACTORS ARE TAKEN INTO
ACCOUNT”
— Recognized that some legitimate concerns of governments when
establishing their national legislation are not generally applicable or
relevant worldwide
— Only those factors which can be accepted on a worldwide basis, or on a
regional basis in the case of regional standards and related texts, should
be taken into account in the framework of Codex
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
JECFA Evaluation of Aluminum
June 2006
 Aluminum evaluated from all sources including food and color
additives
 Based on limited data which was available JECFA established
a provisional tolerable weekly intake (PTWI) of 1 mg/kg bw for
all aluminum compounds
 JECFA withdrew previous PTWI of 0-7 mg/kg bw
 Committee concluded that aluminum has the potential to effect
the reproductive system and developing nervous system at
doses lower then previous PTWI
 Committee requested additional safety data on bioavailability of
different aluminum containing additives, developmental study
and a multigeneration study with neurobehavioural endpoints
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Industry Study Conclusions
 Bioavailability studies conducted by trade associations (IFAC,
IACM and IAI) for 7 compounds
 The IAI Industry association submission to JECFA concluded
the following:
— “In light of recent studies that either filled toxicological
data gaps or reduced uncertainty in the toxicokinetic
differences between test animals and humans, raising
the value of the PTWI by a factor of up to 4 would be
consistent with the currently available scientific data.”
 IAI stated uncertainty factors already applied may be considered
sufficient to address remaining data gaps and uncertainties.
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
JECFA Evaluation June 2011
 The new industry studies were submitted for evaluation of
bioavailability, reproductive, developmental and
neurobehavioural effects
 JECFA Committee then established a PTWI of 2 mg/kg bw; the
previous PTWI of 1 mg/kg bw was withdrawn
 Recommended that the provisions in the GSFA be compatible
with the revised PTWI
 New data did not substantially change the LOAEL range of 5075 mg/kg bw per day; a NOAEL of 30 mg/kg bw per day from an
aluminum citrate study was used to determine the revised PTWI
of 2 mg/kg bw
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
European Union Evaluation of
Aluminum
 EFSA evaluation established a tolerable weekly intake (TWI) of
1 mg/kg bw in 2008
 EU Commission than began drafting restrictions on the level of
use of aluminum from food additives in various food categories
to address the reduced TWI
 In 2010 EFSA refused to increase the TWI based on the new
industry studies and on JECFA’s revised TWI
— If they used JECFA’s preliminary assessment to lower the
TWI, why shouldn’t they use JECFA’s final assessment to
increase and align the EU TWI with global standards?
 Instead, the EU Commission officially amended Annex II of
regulation 1333/2008 to limit aluminum content in various food
categories - Effective 1 August 2014
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Future Considerations to Improve
Harmonization
 Increased participation from all Codex members and
commitments to accept Codex standards will:
— Ensure consumer health protections, and fair trade practices
— Ensure science-based international standards that are good for
government, industry, and consumers
— Promote harmonization through stakeholder consultations
— Promote technical advancements to build market opportunities
 Increased funding is needed for JECFA to facilitate
timely safety reviews and specification development
— How can this be done within the current government funding
paradigm?
— Should industry and governments (U.N.) consider some type of
user fee approach?
— This has worked well in the U.S. for certified colors!
— How can we get this discussion started?
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.
Acknowledgements
 Maia Jack – GMA
 Penny Marsh – Kerry
 Haley Stevens – IFAC
 Chris DeMerlis - Colorcon
The information contained in this presentation is proprietary to Colorcon and may not be used or disseminated inappropriately.