Food Laws

&
Regulation
s
Prepared by:
Ammar Naeem
 Regulatory Bodies in the EU
EFSA is an independent scientific advice
The European body, they provide the European
Commission is the Commission with advice relating to
direct or indirect impact on food and
executive arm of the
feed safety.
EU. European Food Safety
Authority (EFSA)
European Commission Risk Assessors
(EC) Provide opinion of the
safety of new products
European Chemicals Ag and/or re-evaluation of
ency (ECHA) existing products
European European
Council Parliament The European Chemicals Agency is
the driving force among regulatory
authorities in implementing the EU's
chemicals legislation.

Risk Managers / Regulators EU Legislation:

Review & act on opinions & recommendations
following risk assessments. Set new laws &
amendments to existing legislation
• Regulation - binding legislative act. Applicable in its entirety across
the EU 20 days following publication
• Directive - a legislative act that sets out a goal that all EU countries
must achieve. However, it is up to the individual countries to devise
their own laws on how to reach these goals.
EU Regulations and Data Base:
Pesticides/active substance data base
for MRLs – Product wise/Individual
data

https://eur-lex.europa.eu/legal-content/EN/TXT/?
uri=CELEX%3A02006R1881-20140701

Key EU Regulations
Food Additive Regulation
REGULATION (EC) 1333/2008 on Food Additives
What are Food Additives?
• Any substance not normally consumed as a food in itself and not normally used as a
characteristic ingredient of food, whether or not it has nutritive value

• Added to food for technological purposes in its manufacture, processing, preparation,

treatment, packaging, transport or storage, food additives become a component of the
food

• Additives can be used for various purposes. EU legislation defines 26 "technological

purposes“ including sweeteners colours, preservatives, emulsifiers, stabilisers

• Once authorised – food additives can be safely placed on the EU market

• Food additives are assigned E-numbers as a mark of Safety

• Many additives are found in nature

• Food Additive labelling is legally specified in legislation

• Many products in the Ingredion portfolio are food additives – modified starches, food
systems, sweeteners Source: https://www.faia.org.uk/apples-contain/
Codex Alimentarius
International Food Code
“CODEX is a global organisation that
consists of 188 member countries plus
one member organization, the European
Union. Codex Texts are a collection of
standards, guidelines and codes of
practice, based on independent scientific
evidence, and risk-based assessments to
help ensure a consistent, safe global food
supply chain, and to help with import
/export requirements whilst promoting
fair practices”.
“Several nations use CODEX as a
CODEX does not have any legal status instead basis to set their own directives and
it is an international reference point, for
example the World Trade Organization (WTO), regulations such as the EU, FDA,
for purposes of food safety, refers to China and ANZ, others simply adopt
the Codex , additives are globally recognized the Codex Alimentarius directly into
through their international numbering system
provided by Codex, Codex provides standards
their own regulations, such as
for commodities such as wheat flour, certain parts of the ME and Africa”.
chocolate, infant formula and they have
guidelines for best practice regarding hygiene,
test methods and specific testing parameters.
 Codex Alimentarius
International Food Co
de
Search Bar for
searching standard

Honey Codex Regulations; Examples of Codex

regulations:
GENERAL STANDARD FOR FOOD ADD
ITIVES
JECFA – Joint Ex
pert Committee of
Food
JECFA Additives:
serves as an independent scientific
expert committee, which performs risk
assessments and provides advice to FAO,
WHO and the member countries of both
organizations, as well as to the
Codex Alimentarius Commission (CAC).

This database
provides the
most recent
specifications
for food
additives
evaluated by
JECFA
General Standard for Food Additives (GSFA) – 192 -
1995
Important Terms!
General Standard
for Food Additives
(GSFA)
 Middle East
Regulations:
It is a governmental certificate issued
by the Saudi Food and Drug Authority
(SFDA) after reviewing your product
or company files to prove (certify)
that a product or a company has
complied with the required safety,
efficacy, and quality standards set by
the SFDA. I.e. it is the SFDA
approval.
GSO Online Store for Stan
dard purchasing
: 80% of GSO standards are
GCC: GSO
GCC Standardization
The Cooperation Council for the Arab States of Organization (GSO) is a Regional
the Gulf, also known as the Gulf Cooperation Standardization Organization
Council, is a regional, intergovernmental, (RSO) established by the
political, and economic union comprising resolution of the GCC Supreme
Council (22nd Session, Muscat,
Bahrain, Kuwait, Oman, Qatar, Saudi
Oman, 30-31 December 2001).
Arabia, and the United Arab Emirates. GSO operated in May 2004 and
The council's main headquarters is in Riyadh,
its Headquarter is located in
Saudi Arabia.
Riyadh, Kingdom of Saudi
Arabia.
“Moreover, many GSO Standards
are adopted as identical
International standards. At least,
international standards like codex
and EU regulations”.
USFDA
Regulations
:
Owners, operators, or agents in
charge of domestic or foreign
facilities that
manufacture/process, pack, or
hold food for consumption in the
U.S. are required to register the
facility with the FDA.
Federal Food, Drug, and Cosmetic •Food facilities register with
Act - set of laws passed by the
United States Congress in 1938
FDA, and
•FDA be given advance notice
on shipments of imported
food.
giving authority to the U.S. Food
and Drug Administration to
oversee the safety of food, drugs,
The Public Health Security and
medical devices, and cosmetics
Bioterrorism Preparedness and Response
Act of 2002 (the Bioterrorism Act) directs
the Food and Drug Administration
(FDA), to take steps to protect the public
The FDA Food Safety Modernization Act
from a threatened or actual terrorist
(FSMA), enacted on January 4, 2011, amended
attack on the U.S. food supply and other
section 415 of the Federal Food, Drug, and
food-related emergencies.
Cosmetic Act (FD&C Act), in relevant part, to
require that facilities engaged in
manufacturing, processing, packing, or
holding food for consumption in the United
States submit additional registration
information to FDA, including an assurance
that FDA will be permitted to inspect the facility
at the times and in the manner permitted by the
FD&C Act
 WHAT It Is: Domestic and WHY It’s Required: To help WHICH Facilities Must Register:
foreign facilities that FDA to determine the Domestic and foreign food
manufacture, process, location and source of a manufacturers/processors,
pack, or hold food, as potential or actual packers, and storage operations
FDA’s Foo defined in 21 CFR 1.227,
for human or animal
bioterrorism incident or an
outbreak of food-borne
that handle food for
consumption in the U.S. For
d Facility consumption in the U.S.
must register with FDA.
illness, and permit the
Agency to notify quickly
purposes of registration, “food”
is defined in 21 CFR 1.227.
Registratio facilities that may be

n Regulati affected.

on At-a-Gl
Examples of WHICH Foods Require Facility Registration:
 Dietary supplements and dietary ingredients WHO May Register: The owner, operator, or agent in charge of
a facility, or an individual authorized by one of them, may
ance
 Infant formula
 Beverages (including alcoholic beverages and bottled register that facility
water)
 Fruits and vegetables
 Fish and seafood
 Dairy products and eggs
 Raw agricultural commodities for use as food or
Foreign facilities must designate a U.S. agent, who lives or
components of food maintains a place of business in the U.S. and is physically
 Canned and frozen foods present in the U.S., for purposes of communication between
 Bakery goods, snack food, and candy (including chewing the facility and FDA. The U.S. agent also may be authorized to
gum)
 Live food animals register the facility.
 Food for animals (e.g., pet food, pet treats and chews,
animal feed)
In the 1970’s several life-
threatening Clostridium
botulinum out breaks occurred
due to
 Inadequate thermal
processing of commercially
prepared low – acid foods
packaged in hermetically
sealed containers
 Improper acidification of
commercially prepared
acidified food products.
Facts !
1. Low-Acid Canned Food
Regulations (LACF)
2. Hazard Analysis Critical Point
3. Good Manufacturing Practices
 Registration of the Facility that
produces the products as food
canning establishment (FCE)
 Filing of processing information for
all low –acid or acidified foods
produced in the factory (SID)
 Coding on the packaging that
identifies
 The establishment where product
was packed
 The product contained therein
 The year, day, and period during
which it was packed
 What is FCE?
Registration of the physical location that
produces the product (Note: Doesn’t
include office, importer, and warehouses).
FCE, SID, Low Acid The factory is assigned a 5-digit number
CANNED and Acidified(e.g., FCE # 18289)
FOODs Only one number is assigned per factory.
Traditionally, this process takes 5-10
weeks.
Low-Acid Canned Foods:
 Have an equilibrium pH value greater
than 4.6and water activity greater
than 0.85
 Are sealed in hermetic, air-tight
container (i.e., secure against the
entry of microorganisms)
 Receive a heat treatment for the
purpose of achieving commercial
sterility and
 Are normally stored and distributed
under-refrigerated conditions.
What is “Process Filing” (SID)?
An SID is a number assigned to the filings
for process information for low-acid or
acidified canned food with the FDA.
Process filings are required for each
products produced at the factory that falls
under LACF regulations
Each process filing is assigned an SID
number (submission Identifier)
Acidified Foods:
 Are low-acid foods to which acid (s) or acid
food (s) are added for the purpose of
reducing the pH to a finished equilibrium
pH of 4.6 or below.
 Have a water activity greater than 0.85
 Are stored and distributed under non-
refrigerated conditions.
Take Away:
• Fermented products are naturally fermented whereby pH of the food is
reduced to 4.6 or below by the production of acid from the growth of acid –
producing microorganisms. It may be excluded from FCE/SID filings.
• Important factors include pH, water activity, fermentation, carbonation etc.
• Acidified and low acid canned food will always require FCE and SID
registration.
• A product with a pH > 4.6 and water activity > 0.85 requires an FCE and SID
registration.
• A product with acid added to pH < 4.6 and water activity > 0.85 requires an
FCE and SID registration.
CFR - Code of Federal Regulations Title 21
Generally Reco
gnized as Safe (
GRAS)
"GRAS" is an acronym for the
phrase Generally Recognized As Safe.
Under sections 201(s) and 409 of the
Federal Food, Drug, and Cosmetic Act
(the Act), any substance that is
intentionally added to food is a food
additive, that is subject to premarket
review and approval by FDA, unless the
substance is generally recognized, among
qualified experts, as having been
adequately shown to be safe under the
conditions of its intended use, or unless
the use of the substance is otherwise
excepted from the definition of a food
additive.
 Exercise:
If a manufacturer intends to sale product in north Africa region, the
product is emulsified condiment. What is the best approach to start
business in this region.
Exercise:
A manufacturer sells cake product in Middle East, Africa and north
Africa countries. However, he notifies by the authorities, preservative
use in this product exceed the limits mention in regulations of these
countries, and business will not be continued due to violation activity
report. What is the mistake, which has been done by the manufacturer.
Exercise:
Product having pH value greater than 4.6 and water activity greater
than 0.85, but it derives from natural sources and does not involve any
processing steps. Product intends to sale in US region, so what are
prerequisites that the manufacturer need to be done prior to sale in
this product in US region. Manufacturer is in based in Pakistan.
Thank you – Questions Welcome!