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 most 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.