27 August 2005

GM labelling

Genetically Modified Crops

Extract from NSW Parliament (here)

5.0 GMO REGULATORY AND LABELLING REGIMES IN OTHER COUNTRIES

There are no distinct international standards for GMOs, countries are assessing their risks on an individual basis and applying a variety of measures. Rules that require labelling of GM products are being put in place in an increasing number of countries. Most of the important grain importing markets now have mandatory labelling regimes including China, the European Union, Japan and the Republic of Korea. However, the nature of these labelling regimes differs significantly between countries, some of the most important of which are explained below. ²⁵

5.1 United States and Canada

The United States and Canada do not require the labelling of GM foods that have the same properties and characteristics as the conventionally produced counterparts. The US government focuses on the safety of the product rather than the process. By examining the product, the United States Department of Health and Human Services issued regulations in 1992 stating that GM foods did not have to be labeled if the food product had the same characteristics as their non-GM counterparts.²⁶

In 1999 the US Food and Drug Administration began a review of the 1992 labeling regulations, as governed by the Federal Food, Drug, and Cosmetic Act . In issuing a guidance note in January 2001 the Administration stated:

The agency received more than 50,000 written comments about its policy regarding safety and labeling of bioengineered foods. The theme related to labeling in those comments and the testimony at the meetings was that there are very strongly held but divergent views as to whether bioengineered foods should be required to bear special labeling. However, there was general agreement that providing more information to consumers about bioengineered foods would be useful. ²⁷

Nevertheless, the Administration maintained the 1992 labeling regime, and noted:

The agency is still not aware of any data or other information that would form a basis for concluding that the fact that a food or its ingredients was produced using bioengineering is a material fact that must be disclosed under sections 403(a) and 201(n) of the act [Federal Food, Drug and Cosmetics Act]. FDA is therefore reaffirming its decision to not require special labeling of all bioengineered foods.²⁸

However, in issuing the guidelines the FDA emphasised that GM foods need to adhere to labeling laws as per the Federal Food, Drug, and Cosmetic Act . Under this Act, the label of the food must reveal all material facts about the food. Thus:

• If a bioengineered food is significantly different from its traditional counterpart such that the common or usual name no longer adequately describes the new food, the name must be changed to describe the difference.
• If a bioengineered food has a significantly different nutritional property, its label must reflect the difference.
• If a new food includes an allergen that consumers would not expect to be present based on the name of the food, the presence of that allergen must be disclosed on the label. ²⁹
• Brazil - Labeling requirements set down by Presidential Decree came into force on 1 January 2002. Originally GM labeling was required for all foods intended for human consumption where more than four percent of the ingredients are derived from GMOs. However, the threshold was lowered to 1 percent from June 2003.³⁰
• China – In December 2001 China passed new rules to regulate GM foods. Under these rules, production and imports of GM food and food additives are subject to examination and approval. This requires the trading parties to obtain safety certificates, labelling permits and quarantine permits before any foreign GM grain could be brought into China. ³¹ However, there has been considerable confusion over the import requirements, and the Chinese Government mandated a simpler temporary measure. This temporary measure was originally due to expire in December 2002, was extended to September 2003, and it has been reported that it will be extended to April 2004.³² The temporary measure provided that interim safety certificates could be issued based on valid safety assessments issued by the relevant authority in the GM product’s ‘home’ country. Safety assessments based on field trials in China are necessary for permanent approval. The regulations for accidental contamination with GM material have not been determined. ³³
• Japan - A finished food must be labeled as “GM ingredient used” or “GM non – segregated” if it contains more than 5% approved GM product by weight. A finished food may be labeled as “non-GM” if it contains less than 5% approved GM product by weight and the vendor can show that its production and processing used an “identity preserved” approach. Reflecting the international focus on food safety, in early July 2003 the Japanese Government established a new Food Safety Council. The Council will take charge of evaluating a wide range of food materials, including genetically modified food. ³⁴
• Korea - Foods containing soybeans, corn or bean sprouts in the top 5 ingredients by weight must be labeled as “containing GM” if the level of one of these ingredients is greater than 3% by weight in the final food. The Republic of Korea is essentially a non-GM market as retailers avoid placing ‘GM’ labels with soybean and maize products on store shelves to avoid consumer reaction.³⁵
• Taiwan - A finished food must be labeled as “GM” or “containing GM” if it contains greater than 5% approved GM product by weight. ³⁶

5.2 European Union

Foster et al note that the influence of the European Union on the worldwide adoption and acceptance of GM crops is pivotal. This is for two reasons. Firstly, EU human health and environmental safety concerns over GM products seem to spill over to influence attitudes in other countries, particularly poorer countries that do not have the resources to carry out their own safety assessments of GM crops. Secondly, countries with EU markets need to meet EU import standards, which as described below, are restrictive. ³⁷ A detailed review of the EU regulatory environment is therefore required.

European Community legislation on GMOs has been in place since the early 1990s, and the regulatory framework has been further extended and refined, with the most recent amendments in July 2003. The EU now has amongst the most stringent and wide ranging regulations on GM food in the world. This has been described as a reaction to the incidences of mad cow and foot and mouth disease, which has damaged consumer confidence in government regulatory agencies and agribusiness groups.³⁸

The main legislation dealing with the deliberate release of GMOs is Directive 2001/18/EC of the European Parliament and Council, effective from 17 October 2002. This Directive puts in place a step-by-step approval process on a case-by-case assessment of the risks to human health and the environment before any GMO or product consisting of or containing GMOs can be released into the environment or placed on the market. The Directive introduces:

• Principles for the environmental risk assessment;
• Mandatory post-market monitoring requirements, including on long-term effects associated with the interaction with other GMOs and the environment;
• Mandatory information to the public;
• A requirement for Member States to ensure labelling and traceability at all stages of placing on the market;
• First approvals for the release of GMOs to be limited to a maximum of ten years ;
• The consultation of the Scientific Community to be obligatory;
• An obligation to consult the European Parliament on decisions to authorise the release of GMOs; and
• The possibility for Council of Ministers to adopt or reject a Commission proposal for authorisation of a GMO by a qualified majority. ³⁹

Under Directive 2001/18/EC, a company intending to market a GMO must first submit an application to the national authority of the Member State where the product is to be first placed on the market. This application must include a full environmental risk assessment. If the national authority gives a favourable opinion on the placing on the market of the GMO concerned, this Member State informs the other Member States via the European Commission. If there are no objections, the authority that carried out the original evaluation grants the consent for placing the product on the market. The product may then be placed on the market throughout the European Union.

However, if objections are raised and maintained, a decision has to be taken at Community level. The Commission firsts asks for the opinion of its Scientific Committees. If this opinion is favourable, the Commission then proposes a draft Decision of the Regulatory Committee composed of Member States. If the Regulatory Committee agrees, the Commission adopts the decision. If the draft is not adopted, the draft is submitted to the Council of Ministers for adoption by qualified majority or rejection.

Since the original Directive in October 1991, the commercial release of 18 GMOs have been authorised in the EU, mostly by a Commission Decision following a qualified majority vote in the Regulatory Committee. However, since October 1998, no further authorisations have been granted, which left 13 applications pending at the time of its repeal.

Since 1997 labelling to indicate the presence of GMOs as such or in a product was mandatory. In January 2000 the Commission adopted another regulation ensuring that additives and flavourings were also labelled if they contain DNA or protein of GMO origin is present in the final product. Also in 2000, a regulation was passed which limited presence of GM material in conventional food to one percent, below which labelling is not required.

On 25 July 2001 the European Commission adopted two legislative proposals on GMOs, which targeted traceability, reinforced the labelling regime and introduced the labelling of GM feed. These proposals were formally adopted by the European Council of Ministers on 22 July 2003, and have the following effects:

• GM Food – the new laws will extend the current labelling requirements to cover all foods produced from GMOs, irrespective of whether there is DNA or protein of GM origin in the final product. For example, maize oil produced from GM maize, previously not required to be labelled, will now need to be. Food manufactured with ingredients that have been produced from GMOs, for example biscuits with maize oil produced from GM maize will have to be labeled. The GM material in conventional food does not have to be labelled if it can be shown to be adventitious and technically unavoidable, with the threshold reduced to 0.9 percent (from 1.0 percent).
• GM Feed – the regulation introduced for the first time comprehensive labelling requirements for GM feed based on the same principles as for GM food.
• Traceability Requirements – this new regulation requires business operators when using or handling GM products to transmit and retain information at each stage of production. Information concerning the presence of GMOs in products must be transmitted throughout the commercial food chain and must be retained for five years. The industry will have to ensure that systems are in place to identify to whom and from where GM products are made available.
• Authorisation Procedures – these were streamlined to establish a ‘one door one key’ procedure the scientific assessment and authorisation of GMOs and GM food and feed, where the operator is able to file a single application. The newly established European Food Safety Authority will carry out the scientific risk assessment. On the basis of the Authority’s opinion, the Commission will draft a proposal for granting or refusing authorisation, which will be approved through a qualified majority of Member States within the Regulatory Committee (ie, as per previous arrangements). ⁴⁰
• Co-existence – measures to ensure the production of organic and conventional crops can co-exist with GM crops were introduced, allowing Member States to take appropriate measures to avoid cross contamination. Guidelines promoting such measures were identified as:
  • On farm measures such as isolation distances, buffer zones, and pollen barriers ;
  • Co-operation between neighbouring farms, including monitoring and notification schemes, farmer training and advisory services;
  • Cross contamination measures of a regional scale (ie, GM free regions) could also be considered if they are proportioned and if sufficient levels of purity cannot be achieved by other means. ⁴¹

In a statement about the revised legislative framework, the European Commission Health and Consumer Protection Commissioner David Byrne said: “European consumers can now have confidence that any GM food or feed marketed in Europe has been subject to the most rigorous pre-marketing assessment in the world. Consumers will also have a clear choice of products to buy as GM food will now be clearly labelled. For the first time farmers will see labels on GM-feed. Europe will now have a comprehensive and transparent system of authorisation and labelling that can only enhance business and consumer confidence.” ⁴²

On 13 May 2003 the United States announced their intention to request World Trade Organisation consultations on the European Union’s authorisation system for genetically modified organisms. The United States was joined by Argentina and Canada, with Australia, Chile, Colombia, El Salvador, Honduras, Mexico, New Zealand, Peru and Uruguay joined as third parties. United States corn farmers have argued that they are losing about $300 million in sales to the European Union each year because of the effective moratorium since 1998. President George W. Bush is reported to have said: “Acting on unfounded, unscientific fears, many European governments have blocked the import of all new biotech crops. Because of these artificial obstacles, many African nations avoid investing in biotechnology, [and receiving United States food aid which contains GM material] worried that their products will be shut out of important European markets.”⁴³

However, with the adoption of the European Union regulations on 22 July 2003, as described above, it is not clear whether the United States will persist in the World Trade Organisation complaint. ⁴⁴ The United States Department of State had this comment about the new European regulations:

The United States believes that the objective of any regulation should be to protect consumer health and safety while maximizing informed consumer choice. We agree that consumers should have information about the products they purchase so they can make choices. That is what the United States has done for years, but this information should be non-prejudicial in presentation and feasible for producers to provide. We are concerned that the regulations that the European Parliament approved do not meet this standard. The European Union's practice may lead other countries to block trade by imposing similar needlessly burdensome labeling, traceability and documentation requirements, and thus could prompt a host of new, non-tariff barriers just when we are trying to stimulate global trade. We have conveyed our concerns to the European Union and hope they will modify their proposal before adoption. If and when these regulations are adopted, we will examine them in light of the European Union's World Trade Organization obligations.

The European Union's five year moratorium on new biotech approvals is not based on scientific analysis, it blocks consumer choice, and jeopardizes the benefits biotechnology offers to the environment and to feeding the world’ s hungry. It conflicts with the analysis of six national academies of science, including the French Academy of Science and Medicine; and over 3,200 scientists, including 20 Nobel Laureates. We urge the European Union to lift this moratorium immediately. ⁴⁵

5.3 The Labelling of Livestock Reared on GM Feed

Currently no country mandates labeling of livestock product produced using GM materials although the European Union was considering this at one stage, but rejected it. However, a number of large supermarket chains in Europe require their suppliers of food animal products, such as meat, milk and eggs, not to use GM feedstuffs. Many animal products in Europe are labeled as being produced from only non-GM feedstuffs. In Australia, the beef industry is largely based on grass fed animals, but substantial quantities of grain are used in feedlots or to finish grass fed cattle for the market. Supplementary grain feeding of dairy cattle is also increasingly common. However, there is anecdotal evidence that some buyers of Australian livestock products are seeking assurances that GM feedstuffs have not been used in the production process.⁴⁶

5.4 Conclusion

It is evident that the GM regulatory environment worldwide is in a state of change and evolution. Foster et al note that key developments to watch for with both import restrictions and labeling requirements are tolerances specified by governments for adventitious presence of GM material – zero or very low tolerances would make it difficult, if not impossible, to operate a mixed production system of GM and non-GM crops in a way that enable the diverse range of consumer requirements to be met. Other key developments are whether GM labeling is required with animal feeds or with products where the modified DNA or protein is detectable, such as oils – both these actions would substantially increase the amounts of grain products that would require labeling. ⁴⁷