Global Labeling Requirements for Genetically Modified Organisms
On May 4, 2018, the United States Department of Agriculture – Agriculture Marketing Service (USDA AMS) issued proposals for a national bioengineered food disclosure standard.1
64 countries currently have labeling requirements relating to the disclosure of foodstuffs and/or ingredients that have been produced using genetic engineering (GE), more commonly known as genetic modified organisms (GMO).2 The USDA AMS’s proposal will give US consumers greater understanding of food products containing GMOs or ingredients derived from GMOs. While this is positive news for US consumers, the proposal will add to the complexity that already exists around GMO labeling.
The USDA AMS has defined bioengineered (BE) food as substance (matter) that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or be found in nature. The proposal establishes how this information is to be disclosed, exemptions to disclosure, and the record keeping requirements.
A compliance date of January 1, 2020, has been set for the new disclosure rules, except for small businesses which will have until January 1, 2021. These dates correspond to the US Food and Drug Administration’s compliance dates for the new rules for nutritional fact panels, making it more convenient for the food industry.3
The USDA’s Agriculture Biotechnology Glossary defines these terms as follows:
- Genetic Engineering (GE): “Manipulation of an organism's genes by introducing, eliminating or rearranging specific genes using the methods of modern molecular biology, particularly those techniques referred to as recombinant DNA techniques.”
- Genetic Modification (GM): “The production of heritable improvements in plants or animals for specific uses, via either genetic engineering or other more traditional methods. Some countries other than the United States use this term to refer specifically to genetic engineering.”
- Agricultural Biotechnology: “A range of tools, including traditional breeding techniques, that alter living organisms, or parts of organisms, to make or modify products; improve plants or animals; or develop microorganisms for specific agricultural uses. Modern biotechnology today includes the tools of genetic engineering.”
Most countries require the disclosure of GE ingredients to be included on a food’s label. The information is normally imparted using the terms: genetically modified, genetically modified organisms, genetically engineered, or the symbols GM, GMO, GE.4
Disclosure requirements vary greatly around the world. In the EU, the declaration can be very strict in some countries. India, which has had GMO regulations since 2013, has recently issued proposals to strengthen its declaration to all packaged products from 19 categories.5 China, however, while it does have GMO labeling requirements, it does not provide specifics for how the disclosure is to be made.6 In some countries, because of regulatory complexities, ongoing industry debate, or reluctance to comply, GMO labeling requirements have become almost nonexistent, despite being regulatorily mandated.
The USDA AMS is proposing an alternative presentation to the standard GMO reference, either through text stating, “contains bioengineered ingredient” or “bioengineered food”, or via a symbol. The USDA has proposed three symbols, all containing the letters “BE”. This can be disclosed through a digit format. Additionally, small businesses will have the option of including a toll-free phone number and website on packaging to allow the consumer to contact the company for information.
The US is following a similar path on GE labeling to South Africa. Its 2004 health regulations mandate the labeling of GE food in certain cases. These are: when the product includes an allergen, human/animal proteins, or when the GE food product differs significantly from a non-GE equivalent. On October 1, 2011, its new Consumer Protection Bill (68/2008), requiring GE labeling, came into effect, establishing four basic categories and their labeling requirements:
- Above 5% GE ingredients – “contains at least five percent genetically modified organisms”
- Between 1% and 5% GE ingredients – “genetically modified content is below five percent”
- Not possible or feasible to test for the GE traits – “may contain GMO ingredients”
- Below 1% GE ingredients – “does not contain genetically modified ingredients”
The food industry then raised the point of regulatory complexity due to prior regulations, cost, and the challenges of compliance. The South African government agreed that amendments needed to be made and a task force was formed, meeting on July 25, 2014. A period for public comment was then opened on August 15, 2014, but, so far, no new regulations have been published.7
It is easy to see, therefore, that even if a country does have GMO disclosure requirements, they are not always being performed.
The proposed US law will also exclude:
- Meat, poultry, dairy and egg products that come from animals that have eaten BE feed
- Food service establishments and similar retail service establishments
- Very small businesses
- Certified organic products as recognized by USDA AMS
Similar exemptions exist around the world. Australia and New Zealand have exemptions for restaurants and similar food service establishments.8 The EU, Australia and New Zealand exempt animals feed or product from animals that are fed genetically modified feed.
In the EU, food sold in restaurants is not exempted, even when produced from a GMO source, and the USDA AMS is indicating products from a GMO source, such as sugar beet, will also not be exempted. Australia and New Zealand do exempt GM flavorings when they represent no more than 0.1% of the ingredients in the product.
To ensure traceability, companies must maintain effective records. In the EU, traceability is essential for companies to prove their sugar is not from GMO sugar beet and oil is not from a GMO source, especially when the country of origin has approved GMO.
The USDA AMS rules will require companies to keep records of their product’s BE status and produce these records upon regulatory request, and within five days of any request. The form of records will depend on the US marketable crop and whether the BE product is above or below 85% of the total product.
Part of the problem is that farmers tend to utilize seeds from grown crops for the next harvest season, distributing them to neighbors, friends and relatives. GMO seeds can easily cross borders therefore, moving from one that requires labeling to one that does not. This can make full disclosure difficult and hence the need for full traceability.
Following the precedent of just under half of the 64 countries with GMO labeling regulations, the USDA AMS has proposed a limit of 0.9% for inadvertent contamination. In general, countries using the 0.9% limit are countries that ship to the EU, since this is the EU’s long-established standard. Other countries have no limit, and little to no enforcement of these limits, and some have limits between 1% and 5%. India is an example of a country that uses the 5% or more requirement for declaration.
At the moment, there are three countries – Benin, Serbia and Zambia – that have a total ban on GE imports and cultivation. Serbia is now being pressured by the World Trade Organization (WTO) to change its stance, because it prohibits trade bans for non-safety reasons. Stakeholders should also be aware, Bhutan does not have a GMO labeling law but does require that all food is organic.
SGS has a global network of ISO 17025 accredited GE/BE testing laboratories that can perform screening and specific event analysis. We can also help with Non-GMO/GE auditing certification programs, traceability and record keeping with Transparency One, regulatory compliance information with Digicomply, and our label compliance teams can review your product labels against this and other labeling requirements.
For the complete range of SGS services and support visit SGS Food Safety.
For further information, please contact:
Global Food Inspection Technical Manager
t: +1 973 461 1493
1 National Bioengineered Food Disclosure Standard
2 International Labeling Laws
3 Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Extension of Compliance Dates
4 Traceability and labelling
5 FSSAI Proposes GMO Labelling on All Packaged Products
6 Restrictions on Genetically Modified Organisms: China
7 Food and Agricultural Import Regulations and Standards - Narrative
8 Genetically Modified (GM) Food Labelling