GMO hrana zakonska regulativa
Evropska unija
U Evropskoj Uniji (EU) je na snazi specifičan
regulatorni okvir koji se odnosi na GMO i on
se primenjuje još 1990. god.
Od 2004. god. u svih 25 zemalja EU se
primenjuje novi, unapređeni zakonski okvir
Svaki GMO mora imati odobrenje za
određenu vrstu rada sa njim, pre nego što se
pojavi na tržištu EU.
Glavni ciljevi EU
regulative
zaštita zdravlja i životne sredine
obezbeđenje slobodnog transporta
odobrenih GM proizvoda na tržištu EU
sloboda izbora potrošača
Glavni zakonski elementi
regulatornog okvira EU
Direktiva 98/81/EC o ograničenoj upotrebi
GM mikroorganizama
Direktiva 2001/18/EC o namernom uvođenju
GMO u životnu sredinu (obuhvata
eksperimentalno uvođenje GMO u životnu
sredinu i stavljanje u promet GMO);
Regulativa 1829/2003 o iznošenju na tržište
GM hrane i hrane za životinje, kao i hrane i
hrane za životinje koja sadrži ili se sastoji od
GMO
Glavni zakonski elementi
regulatornog okvira EU
Regulativa 1946/2003 o namernom i
nenamernom kretanju GMO između zemalja
članica EU i zemalja van EU;
Regulativa 1830/2003 o sledljivosti i
obeležavanju GMO i o sledljivosti hrane i
hrane za životinje dobijene od GMO;
Regulativa 641/2004/EC,
Regulativa 65/2004/EC,
Preporuka 2004/787/EC itd.
http://ec.europa.eu/food/food/bio
technology/gmo_nutshell_en.htm
General issues
What are GMOs?
Facts and figures about GMOs
Who assesses the safety of GMOs?
Who assesses the safety of
GMOs?
The European Food Safety Agency (EFSA) was established to provide
objective scientific advice on all matters with a direct or indirect impact
on food and feed safety in the EU, including animal health and welfare
and plant protection. European Food Safety Agency’s (EFSA) scientific
output can be classified in two broad categories: "Opinions of Scientific
Committee/Panels" and "other scientific outputs". The Scientific Panel
on Genetically Modified Organisms (GMO Panel) of the European Food
Safety Authority (EFSA) adopted its guidance document for the risk
assessment of genetically modified (GM) plants and derived food and
feed on 24 September 2004. In 2006 the Panel enhanced its guidance
document by adding a chapter on general surveillance of unanticipated
effects. The European Food Safety Authority (EFSA) and the GMO Panel
have consulted stakeholders prior to the final adoption of this
document. This document provides guidance for the preparation and
presentation of applications submitted within the framework of
Regulation (EC) 1829/2003 on GM food and feed, and of Directive
2001/18/EC on the deliberate release into the environment of genetically
modified organisms (GMOs). This document therefore covers the full
risk assessment of GM plants and derived food and feed.
GM Food and Feed
Is the placing on the EU market of GM food and feed
governed by any legislation?
What are the principles of the Regulation on GM foo
d and feed?
What is the authorisation procedure under the Regul
ation on GM food and feed?
Have GMOs already been approved for use in food or
feed products?
What are the current rules on genetically modified va
rieties and seeds?
What are the principles of the
Regulation on GM food and
feed?
the products to which it applies must not:
have adverse effects on human health, animal health,
or the environment;
mislead the consumer or user;
differ from the food/feed they are intended to replace
to such an extent that their normal consumption
would be nutritionally disadvantageous for human
beings (and for animals in the case of genetically
modified feed).
in the case of genetically modified food and feed,
harm or mislead the consumer by impairing the
distinctive features of the animal products.
Have GMOs already been approved
for use in food or feed products?
Products from numerous GMOs can legally be
marketed in the EU. These are mainly processed
foods derived from GM soy, maize, and oilseed rape,
but also oil from cottonseeds varieties, as well as GM
sweet corn. See the Register on GM food and feed.
Further applications for the placing on the market of
GM food products have been introduced and are
currently pending at different stages in the
authorisation procedure. This mainly concerns
products derived from GM maize, sugar beet and
soybean. See the EFSA webpage.
GMOs in the environment
What are GMOs released into the environment?
What does Directive 2001/18/EC introduce?
What is the procedure for authorisation of the experi
mental release of GMOs into the environment?
What is the procedure for authorising the placing on
the market of GMOs as such or as a component in pr
oducts?
How is the environmental risk of GMOs assessed?
Have GMOs already been authorised for release into
the environment?
How is the environmental risk of
GMOs assessed?
identification of any characteristics of the GMO(s)
which may cause adverse effects;
evaluation of the potential consequences of each
adverse effect;
evaluation of the likelihood of the occurrence of
each identified potential adverse effect;
estimation of the risk posed by each identified
characteristic of the GMO(s)
application of management strategies for risks
resulting from the deliberate release or placing on
the market of GMO(s);
determination of the overall risk of the GMO(s).
Ban on GMOs
What are the national safeguard measures?
Are there any national safeguard measures co
ncerning GM foods?
Are any national safeguard measures concern
ing GM seed varieties included in the commo
n catalogue of varieties?
Which EU countries ban the cultivation of GM
Os?
What are the national safeguard
measures?
A number of Member States have invoked the
so-called 'safeguard clause' of the previous
Directive 90/220/EEC. This clause is also included
in Directive 2001/18/EC (Article 23), which
replaces Directive 90/220/EEC.
This safeguard clause provides that where a
Member State has justifiable reasons to consider
that a GMO, which has received written consent
for placing on the market, constitutes a risk to
human health or the environment, it may
provisionally restrict or prohibit the use and/or
sale of that product on its territory.
Which EU countries ban the
cultivation of GMOs?
Six Member States are currently applying
safeguard clauses on GMO events: Austria,
France, Greece, Hungary, Germany and
Luxembourg.
Rules on GMOs already on the
market
Why it is important to trace GMOs in the EU mar
ket?
How does traceability work in practice?
What are the rules on traceability of GMOs?
What are the rules on labelling of GMO
products?
Exemption from the traceability and labelling
requirements.
Will the meat or milk of an animal fed with GM
feed also be labelled as genetically modified?
Why it is important to trace GMOs
in the EU market?
Traceability provides the means to trace
products through the production and
distribution chains. The general objectives are to
facilitate:
implementation, control and verification of GM
labelling requirements;
targeted monitoring of potential effects on health and
the environment, where appropriate;
withdrawal of products that contain or consist of
GMOs where an unforeseen risk to human health or
the environment is established.
What are the rules on
traceability of GMOs? Regulation
1830/2003
1) In the case of a product consisting of or containing GMOs:
operators must transmit in writing to the operator receiving the
product:
an indication that the product – or some of its ingredients –
contains or consists of GMOs and
the unique identifier(s) assigned to those GMOs, in the case of
products containing or consisting of GMOs.
2) In the case of products produced from GMOs: operators must
transmit in writing to the operator receiving the product:
an indication of each of the food ingredients which are produced
from GMOs;
an indication of each of the feed materials or additives which are
produced from GMOs;
in the case of products for which no list of ingredients exists, an
indication that the product is produced from GMOs.
What are the rules on labelling
of GMO products?
Labelling informs the consumer and user of the product,
hence allowing them to make an informed choice.
Generally speaking, for all pre-packaged products
consisting of or containing GMOs, Regulation 1830/2003
requires that operators indicate on a label: “This product
contains genetically modified organisms” or “This product
contains genetically modified [(name of organism(s)]”. For
non pre-packaged products offered to the final consumer or
to mass caterers (restaurants, hospitals, canteens and
similar caterers) these words must appear on, or in
connection with, the display of the product.
What are the rules on labelling
of GMO products?
In particular as regards genetically modified food
and feed, Regulation 1829/2003 lays down specific
labelling requirements.
Genetically modified foods which are delivered as
such to the final consumer or mass caterers
(restaurants, hospitals, canteens and similar
caterers) must be labelled, regardless of whether
DNA or proteins derived from genetic modification
are contained in the final product or not.
labelling requirement also includes highly refined
products, such as oil obtained from genetically
modified maize.
Will the meat or milk of an
animal fed with GM feed also be
labelled as genetically modified?
In line with the general EU rules on labelling,
Regulation (EC) No 1829/2003 does not
require labelling of products such as meat,
milk or eggs obtained from animals fed with
genetically modified feed or treated with
genetically modified medicinal products. Nor
are these products subject to traceability
requirements.
Asynchronous authorisations
What is asynchronous authorisation?
What is the impact of GMO asynchronous
authorisations on the EU market?
Contamination with unauthorised
GMOs
Emergency Measures
Co-existence
What are the rules on co-existence between
transgenic crops and traditional or organic
crops?
In order to help the Member States in developing
national approaches to co-existence, the
Commission adopted, on 23 July 2003, a
Recommendation (2003/556/EC) on guidelines
for the development of national strategies and
best practices to ensure the co-existence of
genetically modified crops with conventional and
organic farming.
The international environment
Is the regulatory framework in line with
international trade rules?
What are the rules governing the movement
and international trade of GMOs?
WTO case on GMO
OECD
Codex
Is the regulatory framework in line
with international trade rules?
The regulatory framework for GMOs takes
account of the EU's international trade
commitments and of the requirements of the
Cartagena Protocol on Biosafety, specifically
as regards the obligations on importers of
products in the EU and the obligations on
exporters of products to third countries.
The EU's regulatory system for authorizing
GMOs is in line with WTO rules: it is clear,
transparent and non-discriminatory.
What are the rules governing the
movement and international trade
of GMOs?
The Codex Alimentarius has developed several documents
regarding the safety assessment of genetically modified
foods. Those documents are the following:
Principles for the Risk Analysis of Foods Derived from
Modern Biotechnology
Guideline for the Conduct of Food Safety Assessment of
Foods Produced Using Recombiant-DNA Microorganisms
Guideline for the Conduct of Food Safety Assessment of
Foods Derived from Recombinant-DNA Plants
Guideline for the Conduct of Food Safety Assessment of
Foods Derived from Recombinant-DNA Animals
WTO case on GMO
The EU is a party to the Cartagena Protocol on Biosafety
annexed to the UNEP’s Convention on Biological Diversity,
which entered into force on 11 September 2003. The overall
purpose of this United Nations agreement is to establish
common rules to be followed in transboundary movements
of GMOs in order to ensure, on a global scale, the
protection of biodiversity and of human health.
The Cartagena Protocol on Biosafety is incorporated into
EU legislation through a wide range of legislative measures
governing the use of GMOs within the European Union. The
cornerstone of this legal framework is Directive 2001/18/EC
on the deliberate release into the environment of
genetically modified organisms.
Regulation on the transboundary
movements of GMOs
The main features of the Regulation are:
the obligation to notify exports of GMOs
intended for deliberate release into the
environment and secure express consent prior to
a first transboundary movement;
the obligation to provide information to the
public and to our international partners on EU
practices, legislation and decisions on GMOs, as
well as on accidental releases of GMOs;
a set of rules for the export of GMOs intended to
be used as food, feed or for processing;
provisions for identifying GMOs for export.
USA
FDA’s regulation of genetically engineered
foods: Scientific, legal and political
dimensions
David L. Pelletier
Division of Nutritional Sciences, Cornell
University, 378 MVR Hall, Ithaca, NY 14853,
United States
EU vs. USA
The European Union and the United States
have strong disagreements over the EU's
regulation of genetically modified food
The US claims these regulations violate free
trade agreements, the EU counter-position is
that free trade is not truly free without
informed consent.
informed consent
Many European consumers are demanding the right
to be informed whether food that they have
consumed had been genetically modified.
Some polls indicate that some Americans would also
like labeling, but it has not become a major issue.
New EU regulations are expected to require strict
labeling and traceability of all food and animal feed
containing more than 0.5 percent GM ingredients.
Also Codex Alimentarius published a document to
safe guard the GM food in 2003 and further
compliances need to be made if the GM food is for
the purpose of exporting and importing.
Good or bad?
A 2003 survey by the Pew Research Center found
that a majority of people in all countries
surveyed felt that GM foods were "bad".
The lowest scores were in the US and Canada,
where 55% and 63% (respectively) were against
it, while the highest were in Germany and France
with 81% and 89% disapproving.
The survey also showed a strong tendency for
women to be more opposed to GM foods than
men
http://en.wikipedia.org/wiki/International_tra
de_of_genetically_modified_foods
Srbija
ZAKON O GENETIČKI MODIFIKOVANIM
ORGANIZMIMA
Zabrana stavljanja u promet
Član 2.
Nijedan modifikovan živi organizam kao ni proizvod od
genetički modifikovanog organizma ne može da se stavi u
promet, odnosno gaji u komercijalne svrhe na teritoriji
Republike Srbije.
Član 3.
Genetički modifikovan organizam ne smatra se poljoprivredni
proizvod biljnog porekla koji količinski sadrži do 0,9%
primesa genetički modifikovanog organizma i primesa
poreklom od genetički modifikovanog organizma.
Semenski i reproduktivni materijal ne smatraju se genetički
modifikovanim organizmima ukoliko količinski sadrže do
0,1% primesa genetički modifikovanog organizma i primesa
poreklom od genetički modifikovanog organizma.
Izuzeci od primene
Član 5.
Odredbe ovog zakona ne primenjuju se na proizvod od
genetički modifikovanog organizma (u daljem
tekstu: proizvod od GMO) koji nije modifikovani živi
organizam ( u daljem tekstu: LMO) i ne koristi se kao
hrana, hrana za životinje, lek ili pomoćno lekovito
sredstvo.
Odredbe ovog zakona ne primenjuju se na genetički
modifikovan mikroorganizam, kao i na proizvod od
GMO koji nije LMO, ako su oni namenjeni za
medicinsku upotrebu i ako je njihova upotreba u
celini regulisana drugim propisima.
