Commenting on the proposals, Environment Commissioner Margot Wallström said: "The provisions for traceability ensure a high level of environmental and health protection and pave the way for a proper labelling system. Certainly, there is a cost for the producers and for trade, but what is at stake is our ability to build public confidence. European companies will only be able to seize the opportunities provided by bio-technology if this confidence is established".
Health and Consumer Protection Commissioner David Byrne emphasised: "These laws will ensure that the regulatory framework in the EU is up to the high standard consumers expect. After that it is for consumers to decide if they want to buy food produced from a GMO. The proposed labelling regime will allow consumers to make that choice. Consumers can be assured that any GMOs in their food have been assessed strictly for their safety.
Equally important to me is that for the first time ever we will have clear rules on GM-feed in place in Europe which is a major contribution to provide trustworthy information to farmers on the feed they buy".
The main European legislation in force on GMOs ensures the scientific safety assessment of GMOs, regulates its authorisation and its use. Its general provisions apply to genetically modified seed, feed and food. The directive also requires traceability and labelling without elaborating on details. Today's proposals specify the details of those requirements designed to protect the environment in case any problem emerges while not imposing too heavy burden on economic operators. Furthermore, the proposals introduce for the first time specific rules on GM-feed in Europe and existing provisions on GM-food are unified and streamlined. The draft legislation presented today takes account the international trade commitments of the European Communities and the requirements of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity as regards importer obligations and notifications.
The adoption of today's proposals together with the recent adoption of the revised legal framework on the deliberate release of GMOs into the environment will build up public confidence by responding to questions and concerns raised by the general public and providing a high level of protection for human health and the environment. This will contribute towards the lifting of the de facto moratorium on the commercial release of GMOs.
Traceability
Traceability entails the ability to trace products through the production and distribution chains. Traceability for certain products has existed for many years. However, specific traceability requirements for products that contain GMOs or are derived from GMOs do not currently exist. The proposed regulation makes it possible to trace GMOs through the production and distribution chain. Traceability facilitates monitoring of any effects on human health and the environment, for accurate labelling and for controlling labelling claims. It is also necessary to enable withdrawal from the market in case of unexpected adverse effects.
In the new Regulation traceability is ensured by putting obligations on business operators to transmit and retain information at each stage of the placing on the market. The industry must have systems in place that identify to whom and from whom GM products are made available. Information concerning the presence of GMOs must be transmitted throughout the commercial chain and must be retained for five years.
Transmission and storage of information will reduce the need for sampling and testing of products. To facilitate a co-ordinated approach for inspection and control by Member State, the Commission will develop technical guidance on sampling and testing methods prior to the application of this proposed regulation.
"The proposal for a harmonised framework for traceability and labelling of GMOs will provide for legal certainty as well as a coherent approach that should contribute to the effective functioning of the internal market," Commissioner Wallström said: "With common rules, we should avoid that Member States establish 15 different systems of traceability. Instead, consumers and operators get one single, effective and transparent system to keep track of GMOs which will operate throughout the EU. "
Labelling
In comparison with the labelling system in place today, the proposal on GM food and feed will add the labelling of:
GM-food
Already today, retailers have to label a food consisting of or containing GMOs. This also includes food produced from GMOs if traces of DNA or protein from the genetic modification is detectable in the final product (such as flour produced from genetically modified maize. However, the labelling provisions do not cover some foods or food ingredients, such as highly refined soya or maize oil. The effect of today's proposal is to extend the current labelling requirements to also cover such food and food ingredients produced from GMOs and to allow consumers to exercise their freedom of choice. The accidental presence of GM-material in food up to 1% will continue to be exempted from the labelling obligation.
GM-feed
The proposal also introduces for the first time strict labelling requirements of GM-feed along the same principle as for GM food. Currently no labelling requirements are in place for feed produced from GMOs. The proposal will require labelling of, for example, GM-soy meal and any compound feed that includes in its composition the GM-soya meal. It will also require labelling of corn gluten feed produced from GM maize. The accidental presence of GM-material in feed up to 1% will be exempted from the labelling obligation.
"The objective of the harmonised and comprehensive labelling requirements proposed is to respond to an overwhelming need to enable the consumer or users to make an individual choice and thereby to foster increased public confidence", said David Byrne.
Adventitious presence
An issue which arises from the cultivation of GMOs is the possibility of the presence of minute traces of unauthorised GMOs in food and feed. These traces may be technically unavoidable during cultivation, harvest, transport and processing. Whether we like it or not this has become a reality. This is not a problem which is particular to GMOs. In the production of food, feed and seed, it is practically impossible to achieve products which are 100% pure.
The present proposal acknowledges this fact and sets up specific conditions under which technically unavoidable presence of unauthorised GMOs could be permitted. In the EU, a number of GMOs have already been assessed by the Scientific Committees as not posing a danger to environment and health. However, these GMOs are still pending final approval.
The proposal allows for these GMOs which have received a positive opinion from a EU Scientific Committee to be present in a food or feed up to a maximum of 1%.
Authorisation procedure
Clear rules are set out in the EU for the assessment and authorisation of GMOs and GM-food but responsibilities are divided between Member States and the Community. It is therefore proposed to establish a "one door one key"-procedure for the scientific assessment and authorisation of GMOs and GM food and feed resulting in a centralised, clear and transparent Community procedure where an operator only has to file a single application. Learning from the US experience with StarLink, the proposal provides that GMOs likely to be used as food and feed can only be authorised for both uses or not at all.
The scientific risk assessment will be carried out by the European Food Authority covering both the environmental risk and human and animal health safety assessment. Its opinion will be made available to the public and the public will have the possibility to make comments. On the basis of the opinion of the European Food Authority, the Commission will draft a proposal for granting or refusing authorisation. The proposal will as it is currently the case be approved through qualified majority of the Member States within a Regulatory Committee. Products authorised shall be entered into a public register of GM-food and feed. The authorisation should be granted for a period of 10 years, subject where appropriate to a post-market monitoring plan. Authorisations are renewable for 10-year periods.
The simplified procedure for putting on the market GM-foods which are considered to be substantially equivalent to existing foods will be abandoned.
Current GM-products will remain eligible for marketing. Operators will however be obliged to provide methods for sampling and detection to the European Food Authority within six months of entry into force of today's proposal. The proposal also establishes the Joint Research Centre (JRC) of the Commission as new Community Reference Laboratory which will have the main task of validating sampling and detection methods. The JRC will continue to work with the "European Network of GMO laboratories".
Existing GM-products shall also be entered into the public register and the time limit of 10 years from the day when the concerned product was first placed on the market equally applies to them.