The Commission has presented a report on the implementation of Regulation (EC) No 1830/2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC.

Adopted in 2003, Regulation 1830/2003/EC, establishes a system for the traceability and labelling of GMOs. In 2006, the Commission forwarded to the European Parliament and to the Council a report on the implementation of the Regulation. However, since only a limited amount of information and experience was available to underpin Member States' input (2005), the Commission has drawn up the current report to give a more complete picture of its implementation. 23 Member States submitted their input, as well as two industry associations. Information from Member States was gathered by means of a 10-part questionnaire concerning the following issues:

Interpretation, implementation and effect of traceability rules : the report states that the majority of Member States reported no problems with interpreting the traceability rules. They noted that overall the system is progressing. As a standard business practice, operators ask suppliers for the necessary documentation, and more and more business operators declare GM modifications in the accompanying documents . However, significant experience suggests that this refers mainly to the feed industry. The majority of Member States have found that the effect of traceability rules on labelling and informed choice is positive, because they facilitate official controls, risk management and the functioning of the entire system. Traceability rules have an overall positive influence on public opinion on food safety, and a favourable impact on the marketing of non-GM products due to the persisting negative perception of GM products by consumers.

Interpretation, implementation and effect of labelling rules : the report highlights that most Member States reported no problems with the way labelling rules were being interpreted by officials. A few Member States noted a lack of clarity about the precise differences between the scope of the Regulation and Regulation (EC) No 1829/2003 for GM food and feed. Member States generally consider the labelling rules to be running smoothly. Identified problems concern mislabelling (e.g. labels indicating that a product "may" contain GMOs), negative labelling in breach of national legislation (e.g. "non-GM" or "GM-free"), lack of documentation indicating GM presence in non pre-packaged products, and lack of labelling despite the 0.9% threshold being exceeded. Some Member States indicated that for GMOs such as feeding-stuffs, the unavailability of information about the adventitious or technically unavoidable presence of GMOs below the 0.9% made it impossible to purchase entirely GM-free products.

Labelling thresholds and adventitious presence of GMOs : the majority of Member States have indicated no particular problems with the proper application of thresholds (0.9%) for the exemption from labelling of food and feed products. However some Member States pointed to the need to resolve the threshold issue in the case of stacked events. There are practical difficulties when a mixture of grains, flours or a processed product has to be analysed, as they might contain different ingredients produced from the same raw material, e.g. starch and flour from maize. Some Member States and stakeholders also pointed to the need for labelling thresholds for the presence of GMOs in seeds. The Commission is currently carrying out an impact assessment to examine this issue.

The use of unique identifiers : the report notes that m ost Member States regard unique identifiers as useful tools for identifying and labelling genetically modified products and report no serious problems.

Inspection and control measures : the majority of Member States reported that overall controls and official inspections are carried out without serious problems. However it should be noted that some of their practices differ significantly. In some Member States the majority of checks are documentary, while sampling and analysis are limited due to the cost factor. Other Member States reported that control officers principally check whether the operators perform "in house" controls in accordance with the regulations. Several Member States made reference to the benefits of training programmes for inspectors, such as the ones provided by the JRC and within the framework of TAIEX, and the advantages of having their laboratories involved in the ENGL network. National provisions have established sanctions for infringing the respective Community and national legislation, including warnings, withdrawal of products, return to country of origin, re-labelling, fines and imprisonment. No serious patterns of infringement have been noted, while most of the identified violations of the law concern non-labelling and insufficient operating procedures for traceability of GM products.

As indicated in the first report, there are still problems in terms of the units in which GM content should be expressed. Recommendation 2004/787/EC advises that "the results of quantitative analysis should be expressed as the percentage of GM DNA copy numbers in relation to target taxon specific DNA copy numbers calculated in terms of haploid genomes". Nevertheless, some Member States ask their laboratories to express measurements of authorised GM materials in weight-% rather than haploid genomes-%, as the labelling threshold in their view must be with respect to weight or number of grains and not DNA content. Some other Member States have noted that method validation according to ISO 17025, as suggested by the Recommendation, depends on the national accreditation body.

Conclusion : Member States and stakeholders have gained additional experience on the implementation of the Regulation since the publication of the last report. This is particularly true of the feed sector, and it has been evident in their input on a series of practical matters. However, the overall experience in the food sector remains modest, mainly due to the limited number of GMOs and derived products currently being marketed in the European Union.

Several problems concerning the application of business practices pose major challenges for GMO policy making and its enforcement in the European Union. Industrial associations and exporters from third countries continue to argue that the Regulation introduces excessive administrative burdens. It restricts the export of GMOs to the European Union, and forces European operators to use high priced conventional products. They consider the labelling thresholds as arbitrary choices and claim that labelling products produced from GMOs, where no GM material can be detected, places an unfair burden on operators in the food and feed sector to verify compliance of refined material.

The Commission considers that several factors, like consumer demand for non-GM products, higher prices in the feed sector and asynchronous approval for GMOs between countries, have had a far greater effect on the trade in GMOs. The requirement for labelling aims to deliver free choice for operators and consumers and should not be considered as an obstacle to the marketing of authorised GM products. The Commission will continue to work with the Competent Authorities of Member States to ensure the appropriate implementation of the Regulation. At the same time it will continue to examine with stakeholders all possible aspects of implementing and possibly improving the policy on the traceability and labelling of GMOs. The Commission (Eurostat) will also continue its efforts to obtain official statistics on GM based products, in particular on the volume of EU imports of GM based products from non-EU countries, on feed market penetration and on GMO cultivated surfaces.

COM(2008)0560
EUR-Lex

Adopted in 2003, Regulation 1830/2003/EC, establishes a system for the traceability and labelling of GMO’s. The requirements apply to products placed on the market containing or consisting of GMO’s and to food and feed products produced from GMO’s. By introducing provisions on traceability, the Regulation intends to control and verify labelling claims; to monitor any effects these products may have on the environment; and to identify and (possibly) withdraw any GMO products in the case of an unforeseen risk to either human health or to the environment.

In order to achieve the objective of traceability the Regulation requires operators to transmit and retain specified information for the GMO product types. Provisions include, inter alia , the need to retain information for a period of five years as well as the establishment of adventitious thresholds (0.9%). The principle of traceability is considered essential for the final labelling of a product. Regulation 1830/2003/EC works in tandem with Regulation 1829/2003/EC on genetically modified food and feed. (See 2001/0173(COD)).

In preparing this report, the European Commission compiled a questionnaire, which was sent to all competent authorities, relevant stakeholders as well as food, feed and seed industry associations and trading partners. NGO’s and relevant Member State government departments were also forwarded the questionnaire, which contained questions on the traceability, labelling, exemptions from traceability and labelling requirements and on the inspection and control measures. The responses were used to compile this report.

Based on the responses received the Commission makes the following findings:

Food production and distribution chains:

- The European food and retailing industries prefer not to market GMO food and food products due to negative consumer reactions. Only a limited number of products are currently being marketed and imported GM material is currently not utilised in food products to any great extent.

- Industry, in tune with consumer likes and dislikes, appears to be responding to retailer and consumer demands for non-GM products. Industry, therefore, avoids purchasing ingredients containing GMO products.

- A large, third country food exporter, states that it no longer exports any processed food products to the European Union due to the burden of the regulatory framework – and cites that this is due to the traceability requirements and not due to a lack of market demand.

- A third-country industry association states that many companies marketing food products in the EU have stopped using internally produced GM soybean oil and protein ingredients in order to avoid what are perceived to be the onerous and costly mandatory traceability requirements.

- A second food association argues that the Regulation has created an unacceptable burden on small food exporters.

- An overseas Government Department claims that the Regulation acts as a barrier to trade and provides a disincentive for manufactures to place GM products on the market.

- The US Government and third country food associations urge the Commission to work together towards a mutual recognition of GM products. The report remarks that the Commission has actively engaged in and remains open to international discussion with the EU’s trading partners but that since 2002, the US Government has been reticent to engage in bi-lateral discussions on issues pertaining to GMO’s.

- NGO’s, on the other hand, claim that the labelling rules have had a positive effect in facilitating informed choice. Indeed, they argue that labelling should be extended to include products derived from animals fed with GM material - such as milk, meat, eggs, wool etc.

Feed production and distribution chains:

- The majority of GMO products circulating in the EU are destined for animal feed and originate in the form of imported commodities such as GMO soybean products. Millions of tonnes of soybean material are imported every year and stem mostly from the US, Argentina and Bra zil.

- Soybeans exported to the EU for feed are mixed by the US commodity-handling system. According to some third-country trading partners it is, therefore, not feasible to transmit the kind of information required by the Regulation. The Commission counters this argument by stating that the European feed industry have been able to report the correct information. Certain industry contacts have suggested that some crushers of non-GM soybeans have had difficulty in selling material due to higher costs.

Labelling and traceability of GM seed products for cultivation:

- The cultivation of GMO’s is not practiced in the vast majority of Member States. BT-maize is commercially grown in some regions of Spain. Some GM varieties are gown in France, Germany, the Czech Republic and Portugal, but only on a small scale.

- The plant biotechnology industry have had no serious problems concerning the interpretation of the Regulation. In countries where GM varieties are available, such as Spain, no particular difficulties have been encountered vis-à-vis the Regulation’s interpretation.

Enforcement of the Regulation:

- Insufficient time, between the Regulation’s implementation and the presentation of this report, has elapsed to gather the relevant experience and information needed for an objective assessment of the current situation.

- Nevertheless, a large majority of Member States deem that the Regulation’s requirements have had a positive effect in terms of providing relevant information to consumers and in terms of providing safety guarantees.

- Some Member States would like to see even stricter requirements for imported GMO goods with even tighter control measures.

- Difficulties have been reported regarding sampling and testing. Techniques for the detection of adventitious presence is cited an example.

- Some Member States would like to see legislation, rather than guidance, on sampling and testing, in order to guarantee a harmonised approach to this matter.

- Some Member States would also like to see harmonised documentation. This would help both the authorities and economic operators to implement the Regulation’s provisions. Industry does not share this view.

- Conversely, other Member States have reported few problems in interpreting, implementing and enforcing the Regulation.

Conclusion:

The Regulation has been operational for a limited period of time. Experience, in terms of the Regulation’s implementation is, as a result, extremely limited. In spite of the above, it appears that the provisions of the Regulation are being correctly applied. Some early “teething” problems have been reported but they appear to have been largely resolved. On the matter of sampling and detection, the JRC and European Network of GMO Laboratories (ENGL) have developed a new methodology for sampling bulk shipments of grain, which has been accepted as an international standards. The JRC and ENGL will continue in their efforts to find specific detection methods for individual GMO’s. In spite of accusations that the Regulation is excessive, the import of soy-meal or corn gluten feed does not appear to have been affected by the Regulations. The report argues that consumer and market demand for foodstuffs have a far greater effect than the Regulation’s provisions. Within 24 months the Commission will draw up a second report in order to gain a more complete picture of the Regulation’s implementation.

COM(2006)0197
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Regulation 2003/1830
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A5-0204/2003

SEC(2003)0362
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COM(2002)0515
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