Genetically modified organisms
A good deal of the EU legislation is designed at controlling risks from the deliberate use and release into the environment of genetically modified organisms. There is a EU framework for release of GMOs and marketing of them in accordance with the so-called precautionary principle. The legislation aims to establish a common methodology for the risk-assessment and safety.
The consent for permitting release and placing in the market of GMOs is for a maximum of 10 years, renewable. Compulsory monitoring is required.
The legislation allows for common methodology to assess case-by-class the risk for the environment associated with the release of GMO.
GMO labelling is compulsory.
The directive applies to common measures on the contained use of genetically modified microorganisms. It is aimed at protecting human health and the environment.
States must take all measures necessary to avoid the contained use of genetically modified microorganisms having negative consequences on human health and the environment.
There are certain exceptions, some of which are covered by other regulations and directives.
The assessment of GMM records must result in a risk hierarchy of the contained uses consisting of four classes:
Class I — no or negligible risk;
Class II — low risk;
Class III — moderate risk;
Class IV — high risk.
Contained used of the GMM requires an examination of the containment and protection measures in order to avoid a release.
When contained uses are to be carried out in premises for the first time, the user must submit to the components authorities’ notification containing at least the information specified in the directive.
Following notification, Class I may be used without further notification. The uses in Class I must maintain certain records.
If the premises have been the subject of a previous notification to carry out a Class II or higher class of contained use and an associate consent has been satisfied, Class II use may proceed following new notification.
If the premises has not been the subject of a previous consent to carry out Class II or a higher class of the contained use, the Class II contained use may in the absence of indication to the contrary from the authorities proceed 45 days after notification or earlier agreement.
Class III or higher may not proceed without the prior consent of the competent authority in writing. The annexes to the directive deal with the criteria for assessing the risks of GMM to health and the environment.
Before use is commenced member states must ensure that an emergency plan is drawn up to deal with accidents and that persons at risk of being affected by an accident are informed of all aspects of their safety,
If an accident occurs the user must immediately inform the competent authority and communicate necessary information. The Commission maintains a register of accidents including analysis of cause.
The EU regulation deals with the placing in the market of GMO, and foodstuffs containing these whether intended for consumption by persons or animals. There is a specific authorization procedure.
Labelling requirement does is not apply to GMO foods in proportion no higher than 0.9 percent of food ingredients considered individually, provided the presence is adventitious and technically unavoidable.
The regulations includes all foods produced from GMOs but just making a distinction between those containing DNA or protein resulting from genetic modification and those which do not. The regulation covers foods with traces of GMOs, GMO derivatives, and those which have not trace of DNA GM proteins.
Legislation puts all genetically modified animal feeds and providers with the same assessment authorization and labelling system as foods for human consumption.
There is a single authorization procedure for all food and feed containing GMOs. The operator can submit his application in accordance with the regulation or split the application and deal with it only in respect of a limited category of GMOs.
Once the application is made, the authority acknowledges receipt and informs the EFSA. It is responsible for risk assessment. It has six months to conduct the assessment.
On the basis of risk assessment carried out the Commission draws up a draft decision accepting or rejecting the application. It submits it to the Standing Committee on Food-Chain and Animal Health. If the committee accepts the proposal it is adopted by the Commission. If not it is passed to the Council of Ministers. The marketing authorization is renewable for 10-year periods.
All products approved in accordance with the regulation are subject to compulsory labelling. The words “genetically modified” are produced and “genetically modified on a (specified organism)” must be clearly displayed.
If the foodstuff or one of its components contain the GMOs or if is produced from such organisms it should be labelled as “GMO.” If it does not exceed 0.9 percent per ingredient and its presence is adventitious or technically unavoidable the foodstuff should not be labelled as a GMO.
GMO and products thereof of food must respect labelling and traceability obligations and other regulations.
There are common measures laid down in the directive for the contained use of GMOs aimed at protecting human health and the environment.
States are required to take measures in order to avoid the contained use of GMMs having negative consequences on human health and the environment. These are genetically modified microorganisms.
There are certain exemptions in the directive including uses involving GMMs unless established in their safety for human health and the environment:
Transport of GMMs by various methods,
Storage, culture, transportation, destruction of GMMs which have been marketed in accordance with legislation.
The assessment of GMMs results in a risk hierarchy of four classes:-
Class I — no or negligible risk.
Class II — low risk
Class III — moderate risk
Class IV — high risk
The contained use of GMMs requires an examination of containment and protection measures in order to avoid a release.
When contained uses are to be carried out for the first time in a premises the user must submit to the competent authorities a notification containing at least the information provided in the directive. Following notification to the authorities of the Class I use — subsequent Class I use may proceed without further notification. Users of GMMs and Class I contained uses must be required to keep a record of each assessment which is available to the competent authority.
If the premises have been the subject of a previous notification to carry on a Class II or higher class of contained use, the Class II contained use may proceed without the new notification. The applicant may himself request from the authority a decision to grant a formal authorization.
If the premises that have not previously been authorized for a Class II or higher class use, the Class II contained use may in the absence of indication to the contrary proceed after 45 days.
A Class III or higher use may not proceed without prior consent of the authority. This is required between 45 and 90 days after submission of the application.
The directive provides criteria for assessing risks of GMMs to health and the environment as well as protection level for each of the four levels of containment.
Before use commences states must ensure that an emergency plan is drawn up to deal with an accident and that persons at risk or being affected are informed of all aspects related to their safety.
If an accident occurs the user must immediately inform the authority and communicate the information necessary for assessing the impact of the accident after taking appropriate action.
States and the Commission must keep a register of accidents including the analysis of the causes, experience gained, and measures taken to avoid similar accidents.
The directive on deliberate release of GMOs requires authorization for such release. Consents last for 10 years, renewable.
There’s a common methodology to assess case-by-case the risks to the environment associated with the release of GMO. Public consultation and GMO labelling are made compulsory.
The regulation on the traceability and labelling of genetically modified organisms allows for monitoring and checking. The regulation concerning traceability and labelling stipulates that traceability is required throughout the food chain.
This is to inform customers and create a safety net of traceability for products through all stages of production and placing on the market. This facilitates monitoring and checking of nutritional claims on the label. Surveillance of potential effects on human health and the environment and withdrawal of products, if an unforeseen risk to human health or the environment is identified.
The regulation covers traceability of GMOs as products or product components including seed or food or feed products produced from GMOs. The traceability applies to all GMOs.
The regulation covers foodstuff and feeding stuff produced from GMOs. All products are subject to compulsory labelling. They must also meet the specific labelling requirements of the general directive regulation on labelling.
Operators must transmit the following information in writing:-
An indication that the products consist or contain GMOs;
Unique alpha-numerical identifiers assigned to the GMOs. Through this system of unique identifiers it is possible to note the producers, features and characteristics for the purposes of surveillance and traceability.
For products which contain a mixture of GMOs the industrial operator may submit a declaration of use of the products together with a list of identifiers assigned to all GMOs used in the mixture.
Operators who place in the market a pre-packaged product consisting of or containing GMOs, must ensure at all stages in the production/distribution chain that the words “This product contains genetically modified organisms or products produced from GM (named organisms)” appear on the label of the product is impossible the operator must ensure the information is transmitted with the product.
Before placing products in the market the operator must transmit the following:-
Indication of each food ingredient produced from GMO;
Indication of each raw material or additive I, foodstuffs produced from GMO;
If no list of ingredients the product must nevertheless bear an indication that it is produced from GMO.
For food and feed products including those intended directly for processing, traces of GMO are to be exempt from labelling obligations if they do not exceed a threshold of 0.9 percent and their presence is adventitious or technically unavoidable.
States must carry out measures to inspect and monitor products including sampling and qualitative and quantitative analysis of food and feed.
The regulation provides for unique identifiers for genetically modified organisms. They must appear on a product’s labelling. The code is uniform .The purpose is to ease identification and traceability of GMO.
Placing in the market of GMOs is regulated by directive. This covers the use in food, animal seed, food ingredients.
All GMOs must be assessed before they can show or place in the market. The risk assessment is carried out on a case-by-case basis and examines the expected, unexpected or possible effects that a GMO may have on health the environment.
Effects linked to GMOs’ potential toxicity, allergenicity, or its effects on non-target organisms are evaluated by national and Community scientific bodies including the European Food Safety Authority.
Once GMO products have been authorized to be placed in the market, the appropriate identifier unique to each GMO must appear on the labelling.
The identifier is made up of nine characters including numbers and letters. The format was approved by the OECD. The identifier for each SMO is listed on the OECD’s BioTrack database.
Regulation provides for authorization for placing GMOs on the market. The industrial operator must submit his application in accordance with the regulation for all food products, feed and food or feed ingredients containing GMOs.
A single form of application is used. This covers use in food, animal feed, cultivation, and release in the environment. Once the application has been made by the operator, the national authority acknowledges receipt and informs European Food Safety Authority. The latter has six months in which to conduct the risk assessment.
The Commission draws up a draft decision accepting or rejecting the application. This is submitted to the Standing Committee on the Food Chain and Animal Health. If the committee accepts the proposal it is formally adopted by the council. If it is not, the proposal is assessed by the Council of Ministers. If the latter does not reach a decision within three months or is unable to reach a qualified majority for or against the Commission adopts its proposal. Marketing authorization is renewable for 10 years.
There are special labelling requirements for GMOs. They must be labelled as such. They must comply with labelling conditions provided for in the regulation relating to traceability and labelling.
There is a common system of notifying and exchanging information on transboundary movements of GMOs to third (outside EU) countries. Exporters of GMO intended for deliberate release into the environment must notify the national authority of the country of import prior to the transboundary movement. This must contain information in the directive.
Where the importer does not apply within 270 days in receiving notification, the exporter must send a reminder to the national authority of the country of import with a deadline of response of 60 days from receipt. The exporter must send a copy of the notification and acknowledgement of receipt to the authority of his state and to the Commission. Under no circumstances may transboundary movements take place without prior written consent from the importer.
Exporters must keep the notification, acknowledgement of receipt and importers’ decision for five years. They must also notify the transit of GMOs to any country upon request.
The Commission or the state which took the decision must notify the Biosafety Clearing House of any decision regarding the use, including placement on the market of GMOs intended for food or feed or for proposing that may be subject to transboundary movement. The notification must contain information in the directive in the regulation.
GMOs intended for food or processing or feed may not be moved across boundaries if they have not been authorized within the Community and if the importer has not given his express consent.
Exporters must ensure that exporter GMOs are clearly identified, that the product states that it contains GMOs and produce-code designed to those GMOs. Exporters of GMOs intended for food or feed or food processing must sign a declaration to the effect that the GMOs will not be deliberately released into the environment. GMOs intended for use in a confined environment must be accompanied by safety rules on storage, transport, and use.
States must take necessary measures to avoid unintentional transboundary movements of GMOs. If occurrence results in the release of a GMO that may lead to an unintentional transboundary movement that is likely to have adverse effects on environment or health, the state must inform the public, notify the Commission and other states and the BCH and relevant international organization and consult the affected state.
With a view to setting up information exchange procedures for exports of GMOs, the regulation specifies that member states must notify the Commission and BCH. The Commission and member states must designate entities responsible for liaising with the secretariat to the protocol in their own name. States must designate competent authorities. The Commission and states must notify the secretariat through the protocol the name and address of their competent professional authority.
The member states and the Community signed Cartagena Protocol in 2000. This is the Cartagena Protocol on biosafety. The aim is to ensure that transfer, handling and use of living, modified organisms resulting from modern biotechnology do not have an adverse effect on the environment and health. It focuses specifically on transboundary movement. The Protocol has been in force since 2003.