Explanatory Memorandum to COM(2001)425 - Genetically modified food and feed - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2001)425 - Genetically modified food and feed. |
|---|---|
| source | COM(2001)425  |
| date | 26-07-2001 |
As part of the framework to improve and bring coherence to Community legislation from 'farm to table' the Commission announced in the White Paper on Food Safety:
* To propose legislation for the evaluation, authorisation and labelling of novel feed, in particular of genetically modified organisms and feeding stuffs derived therefrom (Action 6 in the White Paper).
* To clarify and make the procedure for authorising the placing on the market of novel foods (i.e. foods and food ingredients which have not yet been used for human consumption, in particular those containing or derived from genetically modified organisms) more transparent and review exemptions from these provisions (Action 50 in the White Paper).
* To review Regulation (EC) 258/97 on novel foods and novel food ingredients i, including the introduction of new requirements at least equivalent to those in the revised regulatory framework for the deliberate release of GMOs under Directive 90/220/EEC (now 2001/18/EC) (Action 51 in the White Paper).
* To introduce a general requirement for a new safety evaluation for permitted additives made from new sources or with new methods (Action 41 in the White Paper).
* To complete and harmonise the labelling provisions (Action 52 in the White Paper).
In the context of the adoption of Directive 2001/18/EC i the Commission reaffirmed its intention to supplement the Community labelling regime in accordance with the White Paper on Food Safety.
Contents
* an improved, harmonised, uniform and transparent procedure for safety assessment of genetically modified food
* a safety assessment and an authorisation procedure for genetically modified feed, based on the same improved and transparent authorisation procedure as for genetically modified food
* that authorisation should not be granted for a single use either as food and feed in cases where such products are likely to be used both as food and feed
* harmonised and comprehensive labelling requirements for genetically modified foods with the aim of providing the consumer with a real choice
* harmonised and comprehensive labelling requirements for genetically modified feed in order to provide users with accurate information about composition and properties.
The objectives of this proposal are:
a) to provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, environment and consumers' interest in relation to genetically modified food and feed, whilst ensuring the effective functioning of the internal market;
(b) to lay down Community procedures for the assessment, authorisation and supervision of genetically modified food and feed;
(c) to lay down provisions for the labelling of genetically modified food and feed.
In order to ensure a high level of human and animal health and protection of the environment, this proposal contains the following authorisation criteria for genetically modified food and feed:
- must not present a risk for human health, animal health or the environment,
- must not mislead the consumer or the user,
- must not differ from foods or feed which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for consumers or animals,
- and, for feed, must not harm the consumer by impairing the distinctive features of the animal products.
These criteria do not differ from the criteria laid down in the Novel Foods Regulation, Directive 90/220/EEC (now 2001/18/EC) and the general criteria for placing on the market of feed materials and authorisation of feed additives.
Based on recent experiences and in order to ensure a high level of protection, this proposal provides that authorisation should not be granted for a single use, when a product is likely to be used both for food and feed purposes. Such products would therefore have to fulfil the authorisation criteria for both food and feed before being placed on the market.
Furthermore, in accordance with Article 12 of Directive 2001/18/EC, Articles 13 to 24 of that Directive shall not apply to any GMO or products in so far as they are authorised by other Community legislation. This legislation provides already for specific environmental risk assessment carried out in Annex II and on the basis of information specified in Annex III of that Directive and for requirements as regards risk management, labelling, monitoring as appropriate, information to the public and safeguard clause at least equivalent to that laid down in that Directive. This proposal aims at introducing requirements which are at least equivalent to those of Directive 2001/18/EC and stipulates that the environmental risk assessment, where appropriate, shall be conducted on the basis of the requirements laid down in that Directive.
The proposal covers food and feed containing, consisting of, or produced from genetically modified organisms (hereunder called genetically modified food or feed).
In order to ensure a high level of consumer and animal health protection, this proposal extends the scope of current Community legislation on GMOs to also cover feed produced from GMOs and a specific evaluation of the genetic modification relating to substances such as food additives, flavourings or feed additives, where they have been produced from GMOs.
Authorisation in accordance with this Regulation may be granted:
* for a GMO and food and/or feed containing or consisting of that GMO as well as food and/or feed produced from or containing ingredients produced from that GMO, or
* for a food produced from or containing an ingredient produced from a GMO, as well as food produced from or containing that food,
* for a feed produced from a GMO, as well as feed produced from or containing that feed.
Thus, under the proposed Regulation an applicant shall be able to obtain authorisation of a specific GMO and/or products produced from a GMO for all possible uses in food and/or feed.
Other food or feed business operators wishing to use the authorised GMO or use the authorised products produced from a GMO as ingredients will not have to submit a new application for authorisation, provided that they respect the terms of the authorisation granted. This situation is similar to the one resulting from Article 3 i of the Novel Foods Regulation, except that the latter does not apply to food additives and food flavourings.
The proposed Regulation would cover products 'produced from a GMO', but not products 'produced with a GMO'. The former implies that a proportion of the end product, whether it is the food or feed itself or one of its ingredients, has been derived from the original genetically modified material. The latter is produced with the assistance of a genetically modified organism, but no material derived from the genetically modified organism is present in the end product. Thus, cheese produced with a genetically modified enzyme that does not remain in the final product and products obtained from animals fed with genetically modified feed or treated with genetically modified medicinal products would be subject neither to the authorisation requirements, nor to the labelling requirements laid down in the proposed Regulation. This is in line with the current provisions of the Novel Foods Regulation which covers foods and food ingredients produced 'from' genetically modified organisms, but not foods and food ingredients produced 'with' genetically modified organisms.
For reasons of practicability and legal clarity this proposal does not include the evaluation and authorisation of:
* novel foods which are not genetically modified,
* aspects not related to the genetic modification of substances which are subject to an assessment and a regulatory approval process prior to their inclusion in a positive list or register (such as additives, flavourings, food supplements, etc.).
Where the authorisation granted under the proposed Regulation will relate to the GM counterpart of a conventional substance already authorised for use as additive, flavouring, food supplement etc., these authorised uses will cover the substance authorised under the proposed Regulation.
However, where the authorisation granted under the proposed Regulation will relate to a GM substance whose conventional counterpart is not yet authorised for use as additive, flavouring, food supplement, etc., a specific approval for each specific use will still be required under the relevant legislation. This is not different from the situation that is applicable to conventional (non-GM) food ingredients or feed, where separate applications must be made under the relevant legislation, such as:
* Directive 89/107/EEC concerning food additives,
* Directive 88/388/EEC relating to flavourings for use in foodstuffs,
* Directive 91/321/EEC on infant formulae,
* Directive 96/5/EC on baby foods,
* Directive 2001/15/EC on substances for particular nutritional use,
* COM(2001) 159 on food supplements,
* Directive 70/524/EEC concerning additives in feedingstuffs.
The proposed Regulation is based on the 'one door - one key' principle. Thus, it will be possible, under the proposed Regulation, to file a single application for obtaining both:
* the authorisation for the deliberate release of a GMO into the environment, under the criteria laid down in Directive 2001/18/EC;
* and the authorisation for the use of this GMO in food and/or feed under the criteria laid down in the proposed Regulation.
This authorisation, valid throughout the Community, will be granted subject to:
* a single risk assessment process (covering both the environmental risk and risks to human and animal health), under the responsibility of the European Food Authority,
* a single risk management process, involving the Commission and the Member States through a regulatory committee procedure.
However, the use of the same GMO as seed will not be included in this process, as the conventional variety acceptance criteria do not fall within the remit of the European Food Authority. Moreover, the procedure for accepting conventional varieties under the seeds legislation differs significantly from that for authorisation of genetically modified food and feed under the proposed Regulation. Therefore, it is not foreseen that the inscription into the Common Catalogues of genetically modified varieties should be obtained through this proposal. In a future amendment of Directive 98/95/EC on seeds, the possibility of granting authorisation of genetically modified foods through the seeds legislation will be repealed.
Feed falling within the scope of Directive 82/471/EEC concerning certain products used in animal nutrition i shall be authorised under the procedure laid down in this proposal where it contains or consists of GMOs or is produced from GMOs, instead of the procedure laid down in Directive 82/471/EEC. However, applications related to such products should still be accompanied by the information required under Directive 83/228/EEC ion the fixing of guidelines for the assessment of certain products used in animal nutrition.
The proposal also covers genetically modified food and feed already on the market which have been approved in accordance with the procedures provided for in Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms, in Regulation (EC) 258/97 on novel foods and novel food ingredients, in Directive 70/524/EEC concerning additives in feedingstuffs i and in Directive 82/471/EEC concerning certain products used in animal nutrition.
The provisions in the Novel Foods Regulation concerning genetically modified food will be repealed by this Regulation. The Novel Foods Regulation will remain in place for novel foods, which are not genetically modified, and will be reviewed later this year. Where it will be proposed to apply a (non-GM) production process not currently used, in the sense of Article 1 i (f) of the Novel Foods Regulation, to a food authorised under the proposed Regulation, a specific authorisation will still be required, for that specific process, under the Novel Foods Regulation.
The proposed Regulation (COM(2000) 716 final - 2000/0286(COD) ) laying down the general principles and requirements of food law, establishing the European Food Authority, and laying down procedures in matters of food safety establishes the principles and procedures on which European food law will be based. It specifies that food law has as one of its objectives the high level of protection of human health and life and that, where appropriate to the circumstances, food law should be based on risk analysis. When adopted, it is foreseen that the European Food Authority should carry out the role of the Scientific Committees established respectively by Commission Decision N° 97/404/EC of 10 June 1997 i and Commission Decision N° 97/579/EC of 23 July 1997 i and conduct risk assessments where requested to do so by Community legislation.
In order to streamline and improve the efficiency of the current authorisation procedure for genetically modified foods, this proposal requires that the European Food Authority should carry out risk assessments. As envisaged in the proposal for a European Food Authority, the Authority should also carry out risk assessment for genetically modified feed. This will also ensure a harmonised approach to scientific assessment of genetically modified foods and feed.
This proposal foresees that Community authorisation shall be issued in a transparent and centralised way on the basis of the scientific opinion of the European Food Authority provided that the criteria for authorisation are fulfilled.
In order to ensure clarity, transparency and a harmonised framework for authorisation of genetically modified food, this proposal does not include a notification (simplified) procedure as laid down in Regulation EC No 258/97 on novel foods and novel food ingredients for genetically modified foods which are substantially equivalent to existing foods. The use of this regulatory short-cut for so-called 'substantially equivalent' GM foods has been very controversial in the Community in recent years i and there is consensus at the international level i that whilst substantial equivalence is a key step in the safety assessment process of genetically modified foods, it is not a safety assessment in itself. When reaching a decision on granting a Community authorisation under the proposed Regulation, other legitimate factors relevant to the matter under consideration shall be taken into account. Thus, when initiating the decision-making process, the Commission may well, as a risk manager, propose a Decision which would be different from the outcome of the risk assessment carried out under the responsibility of the European Food Authority. As the case may be, the Commission would have to explain its reasons for such a departure. This is in line with the Codex Alimentarius General Principles on Risk Analysis.
Products authorised under the proposed Regulation shall be entered into a register of genetically modified food and feed, including product specific information, studies which demonstrate the safety of the product and detection methods which have to be provided by the applicant in order to facilitate control. All non-confidential data should be made available to the public.
The initial authorisation should be granted for a period of 10 years subject, where appropriate, to a post-market monitoring plan for the use of genetically modified foods for human consumption and for the use of genetically modified feed for animal consumption. The need for post-market monitoring for use as food or feed is to be assessed on a case by case basis during the risk assessment. In the case of GMOs, a monitoring plan concerning environmental effects is compulsory in accordance with Directive 2001/18/EC.
Authorisations are renewable for ten-year periods upon application to the Authority at least one year before the expiry date.
The proposal provides that the authorisation-holder shall submit any new information related to the conditions of authorisation of the product and any reports as specified in the authorisation to the European Food Authority. If the authorisation-holder proposes to modify the terms of the authorisation, an application shall be submitted to the European Food Authority.
To improve transparency of the decision-making process and the involvement of the public in the authorisation process, a summary of the application for approval of genetically modified food and feed and the opinion of the European Food Authority shall be made available to the public. The public may make comments to the Commission within 30 days after the publication of the opinion.
In accordance with Directive 2001/18/EC, this proposal provides for the opportunity to consult the Commission's European Group on Ethics in Science and New Technologies, established by Decision of 16 December 1997.
After an authorisation has been issued in accordance with this proposal, the authorisation-holder has to ensure that any conditions or restrictions, which have been imposed on the supply or use of the food or feed are respected. However, as a general principle no person should place a genetically modified food or feed on the market, use or process it unless it is covered by an authorisation granted in accordance with this proposal and the relevant conditions of the authorisation are adhered to, which are available to the public via the register of genetically modified food and feed.
It is proposed that existing authorisations and notifications for placing on the market genetically modified foods under Regulation (EC) No 258/97 on novel foods and novel food ingredients and existing authorisations of genetically modified food and feed, granted under Directives 90/220/EEC and 2001/18/EC, Directive 82/471/EEC or Directive 70/524/EEC, should continue to remain in force, provided that additional information concerning the risk assessment, methods for sampling and detection, including samples of the food and feed, are submitted to the European Food Authority within six months of the entry into force of this proposal. The consequence of not meeting this requirement is that the food or feed shall no longer be considered approved for placing on the market in the Community.
If on the basis of new information or a reassessment of existing information, Member States or the Commission have detailed grounds for considering that the use of a food or feed authorised in accordance with this proposal endangers human health, animal health or the environment, safeguard measures to be adopted by the Commission are foreseen.
The labelling of genetically modified foods is currently regulated by several pieces of Community legislation: a) Regulation (EC) No 258/97 on novel foods and novel food ingredients, b) Regulation (EC) No 1139/98 i concerning the compulsory indication, on the labelling of certain foodstuffs produced from genetically modified organisms, of particulars other than those provided for in Directive 79/112/EEC, as amended by Regulation (EC) No 49/2000 i and c) Regulation (EC) No 50/2000 on the labelling of foodstuffs and food ingredients containing additives and flavourings i.
The labelling is triggered by the presence of DNA or protein resulting from genetic modification.
Genetically modified feed has to be labelled in accordance with Directive 90/220/EEC (now 2001/18/EC), which applies only to live GMOs. Thus, no labelling requirements are in place for feed produced from GMOs, but no longer containing GMOs. In addition, until the second revision of Directive 90/220/EEC, labelling indicating the presence of GMOs was not mandatory, so that currently, four authorisations of GMOs for feed use do not require mandatory labelling while four require mandatory labelling.
An appropriate labelling system of genetically modified food and feed is regarded as one of the key issues in ensuring greater acceptance of the application of gene technology in the agro-food sector. The Eurobarometer 2000 and various other surveys throughout Europe show that consumers are demanding clear labelling whether products contain, consist of or have been produced from genetically modified organisms in order to be able to make an individual choice.
This proposal extends the current labelling provisions to all genetically modified food irrespective of the detectability of DNA or protein. Food that consists of, contains or is produced from GMOs would have to be labelled as such. Thus, all products which are subject to authorisation under the proposed Regulation, would henceforth also be subject to mandatory labelling. In return, products which are not subject to authorisation would also not be subject to mandatory labelling. As indicated above, cheese produced with a genetically modified enzyme that does not remain in the final product and products obtained from animals fed with genetically modified feed or treated with genetically modified medicinal products would not be subject to the labelling requirements laid down in the proposed Regulation.
This important change to the current Community legislation on the labelling of food produced from genetically modified organisms will result in labelling of a number of foodstuffs, which are currently not required to be labelled, such as highly refined oils of GMO origin.
It may be argued that the impossibility of checking through analytical methods whether refined ingredients, whether sold as such or when incorporated into final food or feed, have or not been derived from a genetically modified material, will make the proposed labelling provisions unenforceable and will result in frauds. However, it must be noted that the absence of analytical methods has never been considered a valid reason for not subjecting the same products to a pre-marketing authorisation in a number of countries around the World; yet the consequences of fraud are much greater in respect of the authorisation process than in respect of mandatory labelling. Furthermore, there are many examples - in the food sector and in other sectors - of mandatory labelling being imposed despite the absence of any existing analytical methods for controlling the truthfulness of the information being provide on labels; origin labelling, which is required in respect of many foods such as fruits and vegetables, is the most obvious example. Finally, where no analytical methods are available, the accuracy and truthfulness of the information being provided on labels can be controlled through an effective traceability system.
The proposal for a Regulation concerning traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms i would ensure that information concerning whether a food or a feed is consisting of, containing or produced from a GMO is available at all stages of the placing on the market and should thereby facilitate accurate labelling of the final product and provide the means for inspection and control of labelling claims.
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The objective of the harmonised and comprehensive labelling requirements proposed is to respond to an overwhelming need to enable the consumer to make an individual choice and to ensure that consumers are not liable to be misled, and thereby to foster increased public confidence and acceptance of genetically modified foods.
Genetically modified feed should also be labelled based on the same principles as for food to provide final users, in particular livestock farmers, with accurate information on the composition and properties of feed which would enable the user to make an individual choice. This would result in labelling of a large number of feeds, which are currently not required to be labelled with regard to the genetic modification, such as all feed produced from GMOs as well as four genetically modified feed authorised under Directive 90/220/EEC without a labelling requirement.
As already laid down in the Novel Food Regulation, the consumer should additionally be informed about any characteristic or property which render a food not equivalent to its conventional counterpart as regards composition, nutritional value or nutritional effects, intended use of the food, health implications for certain sections of the population and in cases where food may give rise to ethical or religious concerns. It is proposed to apply the same additional labelling criteria to feed.
Despite the fact that some operators make every effort to avoid using genetically modified material, such material may be present in minute traces in conventional food and feed as a result of adventitious or technically unavoidable contamination during cultivation, harvest, transport and processing. In such cases this food or feed should not be subject to the labelling requirements of this Regulation; in order to achieve this objective, it is necessary to establish thresholds for the adventitious or technically unavoidable presence of genetically modified material in food or feed.
In order to ensure the practicability and feasibility of this Regulation, it is also foreseen to establish a threshold of 1 % for minute traces in food or feed of genetically modified material, with the possibility of lower levels to be established by comitology, including genetically modified material not authorised under Community legislation, where the presence of such material is adventitious or technically unavoidable. In order to ensure consistency, it is proposed that Directive 2001/18/EC be amended accordingly.
In order to ensure enforceability, this proposal stipulates that applicants must provide a method for detection, including sampling and identification of the transformation event and, where applicable, for the detection and identification of the transformation event in the food and/or in foods produced from it or in the feed, which can be used for control purposes.
It is proposed to establish a Community Reference Laboratory with the task of testing and validating the proposed methods for sampling and detection, including the reception, preparation, storage and maintenance of control samples submitted by the applicant to provide the means for a harmonious approach for control across the Community. Based on its experience in the field of testing and validation, the Commission's Joint Research Centre is suggested to be the newly established reference laboratory of the Community, assisted by a consortium of national reference laboratories, which will be referred to as the 'European Network of GMO laboratories'
This proposal takes account of the international trade commitments of the European Communities and of the requirements of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity as regards importer obligations and notification.