Food Contact Regulations in Emerging Markets

60 Pages·1.382 MB·English

by  iSmithers Rapra Publishing

food contact > e-book
Food Contact Regulations
in Emerging Markets
this e-book examines the most up-to-date information
on the regulation of FCMs/food packages in each of
the emerging markets.
www.piRa-intERnational.CoM
Food Contact Regulations in Emerging Markets
Pira Business Intelligence
p. Vincent Hegarty
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table of contents
Executive Summary 3 Regulatory Landscape 4 Packaging Processes and Materials
introduction introduction HaCCp for FCMs
Current issues argentina plastics
Regulatory landscape 4argentine Food Code (Caa) plastic Kitchenware
4argentina Brazil 4EU
4Brazil 4FCM Regulations 4US
4China China 4Emerging Markets
4india 4Food Safety law antimicrobial packaging
4indonesia 4Final Food Safety law implementation Measures Canning
4MERCoSUR 4 External perspective on Food Safety law Container integrity
4Russia 4 Ministry of Health active and intelligent FCMs
4South africa 4 Government Directive to Clean Up FCMs Colorants
4thailand 4 Food Safety Violators to Face Death penalty Reduced oxygen packaging (Rop) / oxygen Scavengers
Regulation of packaging processes and Materials 4 External Comment Ethylene-Vinyl alcohol Copolymers
Regulatory outlook for Food Contact packaging india Migration limits
Clarification Regarding applicable Regulations for Food products
1Introduction and Methodology 4Food Safety and Standards Rules, 2011 5 Outlook for Food Contact Packaging
objectives 4prevention of Food adulteration introduction
Scope 4the Food Safety and Standards act, 2006 Regulations—Food production Equipment and Cleaning
Methodology 4Draft Food Safety and Standards Regulations, 2010 new Food packaging Materials and processes
Definitions 4 Regulations in the packaging industry: time for change? 4nanotechnology
indonesia 4 nanotechnology for Food Contact Materials (FCMs) and
2 Food Contact Packaging 4 act of the Republic of indonesia no.7 of 1996 on Food law packaging
Global importance of Food Safety Regulations 4 Government Regulation on Food Safety, Quality and nutrition. 4 nanocomposites
the Global Food Market 4Supervision of imported Food packing Materials 4 nanoclays
4Harmonization of Food laws and Regulations 4 Food Contact Substances Maximum Migration limit 4 nanometals
4 importance of terminology 4words of Caution 4 nanoparticle Coating
4 China MERCoSUR 4 nano-emulsions
4 argentina Russia 4 nanosensors
4 US 4 Federal law on the Quality and Safety of Food products 4 Summary
4 EU 4 Hygienic Requirements for Foodstuff Safety and nutritional Value 4Biopolymers
4 Variation in assessments of Safety --- Bisphenol a (Bpa) 4 Federal agency on technical and Regulating Metrology (GoSt) 4Case Ready packaging
4 EU publications on food packaging/food contact materials: 4plastic vs. Glass Containers
4 USa 4Exporting Food to Russia 4optical Scanning System
4 Canada South africa 4active Films
4 australia/new Zealand 4Food Control
4 China 4Foodstuffs, Cosmetics and Disinfectants List of Tables
4 South africa 4 Definitions
4 Fao/wHo 4the Health act, 1977
4 others 4 Standards and Requirements for Food Containers
4Conclusions thailand
increased Emphasis on Food Safety and FCMs 4 thai Food Contact Material/Food packaging Regulations
Updating Food laws and Regulations 4 thai Guidelines on packaging
Regulating FCMs and Food packaging 4 Feeding Bottle, no. 117/2532 (1989)
Globalization of the Food Supply additional information
4United States Food and Drug administration (FDa)
4European Union
www.piRa-intERnational.CoM
4Codex alimentarius
food contact > e-book > food contact regulations in emerging markets
Executive Summary
Introduction regulations. For example, (EU) no. 10/2011, regarding plastic Emerging markets
Emerging markets will play an increasingly important role in the materials and articles intended to come into contact with food, is are experiencing
production, use and regulation of food contact materials (FCM). an extensive updating and harmonization of regulations within
rapid change
the organisation for Economic Cooperation and Development the EU. therefore, it is advisable to check the most recent status of
in all aspects of
(oECD) categorizes the most important emerging markets as the FCM laws and regulations irrespective of country of interest.
food regulations,
BRiiCS (Brazil; Russian Federation; india; indonesia; China, people’s
including FCMs.
Republic of; and South africa). two other important food trading Emerging markets are experiencing rapid change in all aspects
nations are included in this e-book—argentina and thailand of food regulations, including FCMs. these changes include
(argentina is a member of MERCoSUR—argentina, Brazil, paraguay harmonization of food laws and regulations; this harmonization
and Uruguay). all are members of the world trade organization of regulations is ongoing in MERCoSUR, which includes both
(wto) with the exception of the Russian Federation. this is argentina and Brazil along with paraguay and Uruguay. in 2009,
important information in the event of a trade dispute involving the Russian Federation began forming the Customs Union of the
FCMs if it goes to the wto for resolution. Republic of Belarus, the Republic of Kazakhstan and the Russian
Federation; it is expected to be completed in 2012.
Current Issues
laws and regulations on the composition, use and disposal of FCMs there may be variations in the response of emerging markets to
are of growing importance globally. Regulations are changing current FCM safety issues. Bisphenol a (Bpa) is a good example.
rapidly in response to improved analytical methods, incorporation Since September 1, 2011, China has banned the sale of food
of new technologies and increasing awareness of the importance of containers and bottles used by babies and infants containing
the safety of FCMs by governments, industry, importers, exporters Bpa. South africa issued a draft regulation on Bpa in March
and consumers. all of the countries mentioned in this report have 2011. no action is reported, as of May 2011, by argentina, india,
posted information on food laws and regulations available on the MERCoSUR, and the Russian Federation.
web site of the appropriate government ministry/department.
packaging and FCMs are a part of the Sanitary and phytosanitary
Even so, many countries defer to FCM regulations of the United (SpS) and technical Barriers to trade (tBt) agreements of the
States (US) and/or the European Union; MERCoSUR and world trade organization (wto). Some packaging and labelling
australia/new Zealand are good examples. other countries requirements, if directly related to the safety of the food, are
incorporate the US or EU laws into their national laws and subject to the SpS agreements. tBt measures typically deal with
regulations. the US and EU are constantly updating their FCM packaging requirements for food, packaging and labelling for
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food contact > e-book > food contact regulations in emerging markets
Executive Summary
dangerous chemicals and toxic substances. this is a further reason industry and Foreign trade (MDiC). the national agency of
that emerging nations must have regulatory systems for FCMs that Sanitary Surveillance (anViSta) regulates the toxicological aspects
conform to international norms. of packaging.
Regulatory Landscape China China is undergoing rapid changes in food safety
regulations, including those for FCMs. national food safety
Argentina Food safety and FCM regulations continue to be standards and certification programs based on international
harmonized within MERCoSUR. the argentine Food Code (Caa) standards are now in place, but provinces and industries are
forms the basis of food regulations; it is an extensive document nonetheless allowed to set their own standards. in the absence
including detailed information on FCMs. Caa incorporates of a national food safety standard, a local food safety standard
standards set by MERCoSUR—many of which are influenced by may be developed. the Ministry of Health issued a statement on
standards from Codex alimentarius, the EU and US FDa. april 22, 2011, that China’s food safety standards are consistent
with international standards. the Food Safety law of the people’s
Brazil there are thousands of plastic manufacturers in Brazil, but Republic of China came into effect on June 1, 2009. its coverage
most are small- and medium-sized companies. Resolutions that includes “production and trading of packing materials, vessels,
apply to FCMs are incorporated into “portarias” or ministerial detergents and disinfectants for food, as well as utensils and
decrees and issued by the national agency for Sanitary equipment used in food production and trading (thereafter referred
Surveillance, which, in portuguese, is agência nacional de to as ‘Food-Related products’).” it is important to note that FCMs in
Vigilância Sanitária (anViSa) of the Ministry of Health. new food China are referred to as “food-related products.” Food contaminated
regulations are published in “Diario oficial,” which is similar to the by packaging materials, containers or means of transport is
EU’s official Journal or the US Federal Register. Food contact and prohibited from distribution.
packaging standards and specifications (technical rules) are issued
by the Brazilian association of technical norms (aBnt). aBnt China’s new food safety law modernizes its approach to food safety.
certifies consumer packaging (paper and carton boxes, plastic bags, it increases the use of risk analysis in decision-making, public
steel sheet aluminum cans, pEt bottles, etc) and also regulates information and consumers’ rights, and it emphasizes process
the recycling of packaging and containers for food products. the rather than an end-point focus, as well as food safety supervision.
national institute of Metrology, Standardization and industrial However, some of the problems inherent in the previous laws still
Quality (inMEtRo) regulates the quality and safety of packages exist. these include the lack of a clear or centralizing authority,
and containers for food. it is part of the Ministry of Development, lack of consistent enforcement of the regulations and insufficient
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food contact > e-book > food contact regulations in emerging markets
Executive Summary
oversight of the thousands of small producers. the latter would contend that the laws are little more than technical guidelines
include both the producers and the users of FCMs. the government that specify the quality of the packaging material while ignoring
is aware of these problems—the Ministry of Health issued a the packaging process; they also view the current regulations that
directive in December 2009 to clean up FCMs. this included govern the packaging industry as obsolete, and object to the fact
actively guiding industry to discontinue the use of FCMs harmful that it is not mandatory for manufacturers to specify technical
to human health; accelerating the improvement in the assessment guidelines.
process for FCMs; increasing enforcement against illegal acts in
the production and operation of FCMs; and establishing a long- Indonesia Food safety, including FCMs, is regulated by the
term mechanism for the supervision of FCMs. in May 2011 China’s Ministry of Health (MoH) and the national agency of Drug and
highest court initiated the death penalty for anyone violating food Food Control (na-DFC); in indonesian, it is Badan pengawas obat
safety regulations if people die as a result of these violations—this dan Makasnan or BpoM. Food products regulated primarily by
includes FCMs. na-DFC include packaged food for retail and others to go on for
further processing. all foods imported into indonesia must be
India the packaging industry in india is growing rapidly. about registered through na-DFC. laws regarding the waste disposal of
80% is rigid packaging, and the remaining 20% is flexible packages apply only to those containing expired food.
packaging. Many of the companies are small or medium sized.
Many changes are taking place in food safety regulations in india. the act of the Republic of indonesia no.7 of 1996 on Food law
the Food Safety and Standards authority of india (FSSai) was is the legal basis for the regulation, development and control
established by the Food Safety and Standards act, 2006. FSSai is of the production, import and distribution of food. Government
in the Ministry of Health and Family welfare. it is in the process of Regulation of the Republic of indonesia, number 28/2004, Food
consolidating and developing laws, and it will act as the national Safety, Quality and nutrition has information on food packaging.
regulatory agency for food and for FCMs. Domestic food laws and imported food packing materials are covered by the Supervision of
regulations apply equally to domestic and imported food products, imported Food packing Materials, HK 00.05.155.1621, dated april
including FCMs. the Draft Food Safety and Standards Regulations 13, 2009. attached to this document is a list of 604 food packing
was published in 2010, and most of it is based on existing materials that are allowed into indonesia.
regulations and will be implemented in 2011.
Critics state that many of indonesia’s food regulations are unclear
a lot of progress has been made in establishing FCM regulations and confusing. Many regulations are enforced in a haphazard
within india in recent years, but detractors of the regulations manner or not enforced at all.
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Executive Summary
MERCOSUR MERCoSUR was established in 1991 to harmonize of 1977), Regulations Governing General Hygiene Requirements
national legislations of the member states; other South american for Food premises and the transport of Food (created in 1999)
countries that follow MERCoSUR regulations include Colombia, and Regulation Regarding Food and water Vessels no. R. 1575
peru and Venezuela. September 1971. in March 2011 a draft regulation that bans infant
feeding bottles containing Bpa was published.
Updating FCM regulations began in 2002. Many are based on
EU and/or US regulations for FCMs, including a plastic polymers Critics of South africa’s food control system describe a multiple
positive list. MERCoSUR’s plastic migration regulations follow EU agency control system with fragmentation of legislation, structure
regulations and the European Committee for Standardization (CEn). and functions resulting in operational challenges.
Russia the Russian Federation’s application for membership in Thailand Food safety regulations, including FCMs and food
the wto has been ongoing since 1993; Russia is a member of the packaging, are in Food act B.E. 2522, 1979, implemented by
Russia-Belarus-Kazakhstan Customs Union. Regulations for sanitary, the Ministry of public Health. all packaging and containers must
phytosanitary, technical issues and for FCMs within this union comply with the Ministerial notification no. 92, B.E. 2528 (1985)
are expected to be harmonized by 2012. important mandatory and no. 295, B.E. 2548 (2005); the latter regulation deals with
requirements for food safety and identification are in national plastic containers.
standards codified in State Standards (GoSt). Federal law no.
29-FZ, 2000 on the Quality and Safety of Food products includes Regulation of Packaging Processes and Materials
regulations on FCMs. Emerging markets have a formidable task in keeping their
regulations on FCMs up-to-date and in conformity with major
Critics contend that agencies’ control over imported food remains food trading areas such as the EU and USa. Recently, food safety
complicated and bureaucratic. Barriers to trade depend on the type agencies in both australia and new Zealand have provided
of product, customs clearance location, importer’s status, and other useful information on FCMs for consumers. this consumer-focused
non-transparent factors. material could become a template in emerging markets.
South Africa the national Food Safety Division of the Ministry of Many emerging markets must move from end-point testing to the
Health is responsible for all ready-to-eat food products. legislation incorporation of Hazard analysis Critical Control points (HaCCp)
related to FCMs is contained in Foodstuffs, Cosmetics and for FCMs. Recent EU updating of regulations on plastics and on
Disinfectants act no. 54 of 1972, the Health act, 1977 (act no. 63 the importation of polyamide and melamine plastic kitchenware
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Executive Summary
from China has implications for all emerging markets. antimicrobial in summary, this is a time of great opportunities and great
packaging has potential benefits for a number of perishable challenges in the regulation of FCMs in emerging markets.
commodities. Many of the emerging markets are in countries with Government agencies must initiate and implement up-to-date laws
have high temperatures and humidity, so antimicrobial packaging and regulations for FCMs that conform to international standards.
should have a positive impact on food quality and safety. Commercial interests all along the food chain must comply with the
Regulatory agencies in emerging markets must give increased latest FCM regulations. Consumers must be aware that materials
attention to the creation and implementation of appropriate in contact with food are an important component of a safe food
regulations to cover developments in canning, container integrity, system.
active and intelligent FCMs, colorants, reduced oxygen packaging
(Rop), ethylene-vinyl alcohol copolymers and migration limits.
it is advisable that food exporters or importers dealing with any
of the emerging markets confer with appropriate government
authorities and consultants before beginning trade discussions.
Regulatory Outlook for Food Contact Packaging
Creating and updating regulations to meet rapid changes in
FCMs will present significant challenges for emerging market food
safety agencies and for all segments of the food chain in emerging
economies over the next 5 to 10 years.
among the expected changes are the inclusion of HaCCp in
the production and application of FCMs. new food packaging
materials and processes will require regulations as well as training
for inspectors and for implementers of those regulations along
the entire food chain. these new materials include the products
of nanotechnology as applied to FCMs, biopolymers, case ready
packaging, optical scanning systems and active films.
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food contact > e-book > food contact regulations in emerging markets
1 Introduction and Methodology
Objectives Scope this e-book
1. to provide the most up-to-date information on the regulation this e-book examines the laws and regulations for food contact examines the laws
of FCMs/food packages in each of the emerging markets. the materials (FCMs)—especially for plastics, canned foods, paper, and
and regulations
primary sources for regulatory information are the government the standards and requirements for food containers in the following
for food contact
agency/agencies responsible for the formulation and emerging markets:
materials (FCMs)—
implementation of laws and regulations on FCMs. • Argentina
especially for
2. to make the latest information on FCM regulations as accessible • Brazil
as possible; to that end, an extensive listing of website • China plastics, canned
information has been cited throughout this e-book. • India foods, paper, and
3. to make the connection between the emerging markets • Indonesia the standards and
and both the US and EU markets because of: a) the large • MERCOSUR (Argentina, Brazil, Paraguay, Uruguay)
requirements for
import and export food markets between the US/EU and the • Russia
food containers
emerging markets, and b) several emerging countries defer to • South Africa
the FCM regulations of the US and/or the EU. this objective • Thailand
is timely because of the February 2011 announcement by the world trade organization (wto) does not have a definition
the Global Food Safety initiative (GFSi) introducing the new for “developing” or “emerging” markets/countries. “Members
packaging technical working Group (www.mygfsi.com), which announce for themselves whether they are ‘developed’ or
was initiated because of... “growing concerns over the need to ‘developing’ countries. However, other members can challenge
provide a streamlined, harmonized approach to the food safety the decision of a member to make use of provisions available to
requirements which can be found in the plethora of packaging developing countries.” www.wto.org/english/tratop_e/devel_e/
standards existing today in the food industry.” d1who_e.htm
4. to indicate issues of concern in the current regulation of FCMs
in emerging markets. these critical analyses are taken from all of the aforementioned countries are members of the wto with
government or non-profit agencies within the respective country the exception of the Russian Federation, which made its application
or from peer-reviewed international journals. for membership in 1993 but has not been admitted yet. these
5. to review emerging markets’ regulatory developments in FCMs distinctions are important in the event of an international trade
and how they deal with new regulatory issues in FCMs. dispute involving Food Contact Materials (FCMs) making its way to
the wto.
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Introduction and Methodology
the organisation for Economic Co-operation and Development to make protective coatings and linings for food and beverage
(oECD) recognizes the increasing economic significance of the cans and vats. Bpa can migrate in small amounts into food and
BRiiCS (Brazil, Russian Federation, india, indonesia, China and beverages stored in materials containing the substance.
South africa). www.oecd.org/dataoecd/35/34/42324460.
pdf MERCoSUR (includes argentina) and thailand are included Colorant (US FDA): a dye, pigment or other substance that is
because of their increasing significance in world trade in food. used to impart color or to alter color of a food-contact material;
it does not migrate to food in amounts that will contribute to
Methodology that food any color apparent to the naked eye. the term colorant
information in this e-book was obtained from a thorough review includes substances such as optical brighteners and fluorescent
of secondary research on FCMs. Sources included regulatory whiteners, which may not themselves be colored, but whose use is
agencies in emerging countries, government reports, articles on intended to affect the color of a food-contact material.
food packaging and FCMs in peer-reviewed journals. all websites
referenced throughout this e-book were verified as of June 1, 2011. Engineered nanomaterial (ENM), also known as
manufactured nanomaterials (FAO/WHO): any material
Definitions that is intentionally produced in the nanoscale to have specific
the source is given for some definitions that are transcribed properties or a specific composition.
verbatim. this is important because the terms and definitions for
some FCMs and FCM-related issues may differ between countries. Food contact materials (EU): all materials and articles
the reader is advised to check with the appropriate national intended to come into contact with food, such as packaging and
authority on their definitions and terms prior to the commencement containers, kitchen equipment, cutlery and dishes. these can
of any discussions/negotiations. be made from a variety of materials, including plastics, rubber,
paper and metal. Food contact materials also include those used
Bisphenol A (BPA) (EU): a chemical that is mainly used in processing equipment, such as coffee makers or production
in combination with other chemicals to manufacture plastics machinery as well as containers those used in transport. in
and resins. For example, Bpa is used in polycarbonate, a high- addition, EU legislation for food contact materials covers materials
performance transparent, rigid plastic. polycarbonate is used in contact with water intended for human consumption, e.g.
to make food containers, such as returnable beverage bottles, bottles (with the exception of fixed public or private water supply
infant feeding bottles, tableware (plates and mugs) and storage equipment).
containers. Residues of Bpa are also present in epoxy resins used
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