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EUROPE

European Union

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Directive 2001/18/EC (Deliberate Release of GMOs into the Environment)

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Selected Legal Annotations and Comments

This is the primary piece of horizontal EU legislation on GMOs and the environment. It addresses the release of GMOs into the environment for purposes other than placing on the market, as well as the placing on the market of GMOs. It will replace Directive 90/220/EEC on 17 October 2002 by which time Member States are to comply with it (art. 34). Directive 90/220/EEC was supplemented by a collection of sectoral directives and regulations. The relationship between the existing sectoral legislation and the new Directive is unclear as the Directive refers to some and does not refer to others. The Commission is also bringing forward a number of proposals to rationalize the collection of legislation, especially in the food safety area.

The Directive’s preamble reflects the principles upon which the Directive’s substantive provisions are based. The Directive derives from the principle embodied in the Treaty Establishing the European Community that Community action on the environment should based on preventative action (preamble para. 6). The precautionary principle is to be considered in the Directive’s implementation (preamble para. 8). Member States may consider ethical aspects when GMOs are released into the environment or placed on the market (preamble para. 9). The Directive also promotes transparency by emphasising the necessity of public consultation, either by the European Commission or the Member States (preamble para. 10). Case by case environmental risk assessment is to be always carried out prior to release, in particular to identify long term effects (preamble para. 19; article 4(3)) and monitoring should be undertaken after release (preamble para. 20). Members and the Commission should ensure systematic and independent research into the potential risks of GMO release or marketing (preamble para. 21).

Deliberate Release of Viable GMOs for Purposes Other than Placing on the Market (Part B)

GMO introduction into the environment is premised on the “step by step” principle whereby GMO containment is reduced, and the release scale is gradually increased, but only if earlier human health and environmental evaluations of previous steps indicate the next step can be taken (preamble para. 24). Competent national authorities must be notified and provide consent before any deliberate release takes place (preamble paras. 32 and 34; art. 6(1)). Notifications are to include a technical dossier including a full environmental risk assessment (preamble para. 33; art. 6(2)). The period of consent for release is unclear. Notifiers must report on the result of the release in respect to any risk to human health or the environment with particular reference to any product that the notifier intends to notify at a later stage (art. 10).

Differentiated (exceptional or simplified) procedures can be proposed to the Commission by the competent national authority where sufficient experience has been obtained for certain GMOs proposed for releases that meet specified criteria (art. 7(1)). The Commission seeks observations and comments from other Member State competent national authorities and the public, respectively (art. 7(2)(a) and (b)). It seeks an opinion from relevant Scientific Committees (art. 7(2)(c)) as well. The Commission next decides the minimum amount of information necessary to evaluate foreseeable risks that is to be provided to the competent national authority (art. 7(3)). The notifier then must comply with any conditions set forth by the competent national authority (art. 7(5)). Other simplified procedures apply for genetically modified plants pursuant to Commission Decision 94/730/EC (art. 7(6)).

Article 9 applies to public information and consultation with respect to environmental releases. In general, Member States shall consult with the public, including groups. They are to create arrangements for consultation, including reasonable time periods for the expression of opinions (art. 9(1)). In addition, Member States are to make information available to the public on all GMO releases into the environment (art. 9(2)). In addition, the Commission is to make available to the public the information contained in the system of information exchange between the Commission and the Member States’ competent authorities (art. 9(2), which includes summaries of the notifications received by the competent authorities, observations and a list of GMOs released within the Member States’ territories (art. 11). These provisions are qualified by article 25 (Confidentiality).

The Commission and competent national authorities shall not divulge to third parties confidential information notified or exchanged under the Directive (art. 25(1)). The notifier may indicate that information whose disclosure might harm his competitive position and which should be treated as confidential (art. 25(2)). He must provide verifiable justification. The competent national authority consults with the notifier and decides which information shall be kept confidential (art. 25(4)). Information that cannot be kept confidential includes inter alia a general description of the GMO, monitoring methods and plans, emergency responses and environmental risk assessment (art. 25(4)).

Information exchange is to take place between competent national authorities and the Commission (art. 11). A summary of each notification received by the Member State is to be provided to the Commission (art. 11(1)). The Commission in turn forwards the summaries to other Member States who may make observations to the Commission or directly to the relevant competent national authority (art. 11(2)). The competent national authorities of other Member States may subsequently request the full notification. It is unclear to what extent the article 25 confidentiality provisions may apply to another Member State’s receipt of the full notification. The extent the observations from other Member States must be considered is also unclear. Competent national authorities must inform the Commission of the final decisions taken, including any reasons for rejection (art. 11(3)).

Placing on the Market as or in Products (Part C)

Directive 2001/18/EC is to act as a reference for GMOs as or in products authorized by other Community legislation inter alia with regards to environmental risk assessment, risk management, labelling, monitoring and public information (preamble para. 27). In general, GMOs, whether individually or in combinations, intended for placing on the market as or in products must have been subjected to satisfactory field testing in the research and development stage in ecosystems that could be affected by their use (preamble para. 25). The general procedures for notification of and consent by the competent national authorities are similar to those for release into the environment (Part B). Notification is sent to the competent national authority of the Member State in which the product will be marketed for the first time. Notifications are to include a technical dossier including a full environmental risk assessment and, for products, precise information for use and proposed labelling and packaging (preamble para. 33; art. 13(2)(f) and (g)). The proposed labelling must include the words “this product contains genetically modified organisms” clearly displayed either on a label or in accompanying documentation (preamble para. 40; art. 13(2)). On the basis of results from Part B, or on other substantive, reasoned scientific grounds, a notifier may propose to the competent authority not to provide information required in the Directive Annex IV (B) (Additional Information) because the product posed no risk to human health and the environment (art. 13(2)(h)).

The competent national authority forwards a dossier summary immediately to other Member States and the Commission (art. 13(1)). Upon a complete notification, the competent national authority prepares an assessment report indicating whether the GMO should or should not be placed on the market (art. 14). Where the Commission or another Member State do not object to the marketing then the competent national authority may provide its consent in writing, subject to its conditions, and notifies the Commission and other Member States (art. 13(3)). Conditions will inter alia include monitoring and the public release of subsequent results to ensure transparency (art. 20(4)). Consent is given for 10 years (art. 14(4)) with exceptions provided for GMOs intended only for the marketing of their seeds and forest reproductive material. Consent can be renewed subject to further review and additional conditions (art. 17). In addition, the Member State is to take emergency measures, including providing public information, when the GMO or the product presents a severe risk after consent has been granted (art. 23(1)).

Where objections are lodged, a committee procedure under article 30 (Committee Procedure) is activated to resolve objections. The Commission drafts a decision reflecting the concerns of the Member States. A vote is taken. Where resolution is not possible, the Council of Ministers decides. If the Council fails to decide within three months, the Commission can adopt its decision.

Member States are to take “all necessary measures” to ensure that the written consent, and decisions by the committee created to address Member State objections to a notification (art. 18) are made accessible to the public (art. 19(4)).

The competent national authority or the Commission may propose derogations from the information requirements specified for notifications (art. 16(1)) but “relevant scientific committees” must be consulted (art. 16(2)). The Commission (art. 16(3)) must notify proposals for derogations to the public. Public comments and an analysis are forwarded to a committee set-up to consider the derogations (arts. 16(3) and 30).

Member States are to ensure that labelling and packaging of GMOs placed on the market as or in products comply with the conditions of consent (art. 21(1)). Where adventitious or technically unavoidable traces of authorized GMOs cannot be excluded, minimum thresholds may be established below which the products require no labelling (art. 21(2)). Thresholds will be product specific and will be established through the EC committee procedure laid down in article 30(2).

Where consent for marketing is provided in one Member State, other Member States may not prohibit, restrict or impede the GMO product’s marketing (art. 22). However, a Member State may provisionally restrict or prohibit a GMO’s sale or use as or in a product within its territory when it has obtained new or additional information after consent has been given. The information is related inter alia to the environmental risk assessment or new scientific knowledge (art. 23(1)). A decision is taken through the committee procedure outlined in article 30(2).

In contrast to Part B’s provision on public information where the burden is placed on the competent national authority, the Commission has the responsibility to make available to the public the dossier summary provided with the notification (art. 24(1)). This is to happen immediately upon the notification’s receipt. The public may make comments within 30 days and these are to be forwarded to the competent national authorities. In addition, the assessment reports for GMOs attaining written consent, and the opinions of any Scientific Committees consulted, must also be made public (art. 24(2)), but it is unclear who is to do this. The release of information to the public in all cases is subject to the confidentiality provisions of article 25.

A system will be designed to assign a unique identifier for GMOs (preamble para. 41). In all stages of placing on the market, traceability of the GMO as or in products is to be ensured by the Member State (preamble para. 42, art. 4(6)). This will take account of international developments. Monitoring plans are required to trace and identify any direct or indirect, immediate, delayed or unforeseen effects on human health or the environment of GMOs as or in products after their placement on the market (preamble para. 43).

Miscellaneous and Final Provisions

The Commission shall consult “relevant scientific committees”, on its own initiative or at the request of a Member State, when objections are raised to marketing a GMO based on risks to human health or the environment (art. 28(1)). Relevant scientific committees shall also be consulted where an assessment report indicates GMO should not be marketed. Any other matters may also be put to the relevant scientific committee (art. 28(2)). The procedure for actually creating a committee is unclear.

At its own initiative, or upon request of the European Parliament, the Council of Ministers or a Member State, the Commission may also consult any committee it has created to obtain advice on the ethical implications of biotechnology, such as the European Group on Ethics in Science and New Technologies (art. 29(1)). This is without prejudice to the competence of Member States on ethical issues. The consultation is to be based upon openness, transparency and accessibility to the public (art. 29(2)). Results shall be publicly available.

The Commission is to establish publicly accessible registers on genetic modification that “shall include a part which is accessible to the public” (art. 31(2)). Member States are also to create public registers with release site locations for Part B GMO releases (art. 31(3)(a)). They are to also create registers for GMOs grown under Part C whose locations shall also be publicly available (art. 31(3)(b)).

The Commission will submit a report to the European Parliament every three years to report on the experience of Member States. The upcoming report for 2003 will include an assessment of inter alia of the socio-economic implications of deliberate GMO releases and subsequent marketing (art. 31(7)(d)). Finally, the Commission will report annually to the Council and the Parliament on ethical issues (art. 31(8)), including proposals to amend the Directive.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Regulation 258/97/EC (Concerning Novel Foods and Novel Food Ingredients)[4]

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Selected Legal Annotations and Comments

This regulation applies to the placing on the market for the first time of novel foods or novel food ingredients (i.e. “foods that have not hitherto been used for human consumption to a significant degree”) (art. 1(1 and 2)). This includes inter alia (1) foods and food ingredients containing or consisting of GMOs, (2) foods and food ingredients produced from, but not containing, GMOs (art. 1(2)(a) and (b)). The criteria for authorization are the food and food ingredients must not (1) present a danger for the consumer; (2) mislead the consumer; or (3) differ from foods or food ingredients which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer (art. 3(1)).

Requests for authorization are made to the Member State in which the product will be placed for the first time (art. 4). The Commission receives a copy from the applicant. When the food or food ingredients contain or consist of a GMO additional information requirements for the application apply (art. 9(1)). These include the written consent for the earlier deliberate release for research and development purposes and a technical dossier supplying information requested by Directive 90/220/EEC (now 2001/18/EC) on deliberate release with the environmental risk assessment.

The Member State undertakes an initial assessment to determine whether an additional assessment (further review) is required (art. 4(2)). The competent food assessment body preparing the assessment report is notified to the Commission (art. 6(2)) and the Commission in turn provides the Member States with this information and the applicant’s summary. The initial assessment is forwarded to the Commission and subsequently forwarded to the Member States (art. 6(4)). The Commission and Member States may comment or present reasoned objections, which may also address labelling issues. Comments or objections are circulated to the Member States.

Where an additional assessment is not needed and there are no objections to the application then the Member State notifies the applicant that it may place the food or food ingredient on the market (art. 4(2)). Where an additional assessment is required or objections exist the authorization decision takes place at the Commission level (art. 7(1)). The procedure for the authorization decision is specified in article 13 and includes using the Standing Committee for Food Stuffs to review and deliver opinions on draft measures to be taken (art. 13(1-3)). The Commission can adopt the measures to be taken provided they are in accordance with the Committee’s opinion (art. 13(4)). The decision shall define the scope of the authorization and establish conditions of use, the food or food ingredient’s designation and specific labelling requirements (art. 7(2)).

A Member State may subsequently temporarily restrict or suspend the trade in and use of the food or food ingredient within its territory (art. 12(1)). This must be based on new information or reassessment of existing information that provides a Member State with detailed grounds to consider the use of the food or food ingredient endangers human health or the environment. The Commission examines the grounds in conjunction with the Standing Committee on Foodstuffs pursuant to the procedure in article 13.

Labelling requirements in addition to other Community labelling requirements can be specified for foodstuffs to ensure that the final consumer is informed. Among these, additional labelling is required when (1) any characteristic or food property no longer renders a novel food or food ingredient equivalent to an existing counterpart (based on scientific assessment and accounting for natural variations); (2) the presence of material not present in the existing counterpart and which may have human health implications for certain population sectors; (3) the presence of material not found in existing counterparts that gives rise to ethical concerns; and (4) the presence of GMOs (art. 8(1)). Where an existing equivalent counterpart does not exist appropriate provisions are to be adopted to ensure that consumers are adequately informed of the nature of the food or food ingredient (art. 8(2)).

A derogation procedure is available for food or food ingredients when the applicant believes they are “substantially equivalent” to existing foods or food ingredients. This determination is based on the criteria in article 3(1) described earlier. To support this, the determination must be based on: (1) available and generally recognized scientific evidence or (2) on the basis of a Member State’s competent food assessment body (arts. 3(4) and 5). In this procedure the applicant notifies the Commission with relevant details and these are forwarded to Member States (art. 5). The Standing Committee on Foodstuffs (art. 13(1)) may assist the Commission. The Commission drafts a decision that is considered by the Committee (art. 13(3)). The Commission adopts the measures when they are in accordance with the Committee’s opinion (art. 13(4)(a)). The Council of Ministers votes on the Commission draft where the Committee’s opinion differs with Commission’s measures. The Commission can adopt its measures when the Council fails to act (art. 13(4) (b))

In this regulation there do not appear to be any requirements for stakeholder participation at the Community level, other than co-ordination between the Member States. In addition, there are no requirements of stakeholder participation at the national level.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Regulation 1139/98/EC (Labelling of Certain Foodstuffs Produced from GMOs) as amended[5]


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Selected Legal Annotations and Comments

Regulation 1139/98 derives from Directive 79/112/EEC (Approximation of the Laws of Member States Relating to Labelling, Presentation and Advertising of Foodstuffs). It was amended by Regulation 49/2000/EC. As amended, Regulation 1139/98 covers food and food ingredients that are delivered as such to the final consumer or mass caterers (e.g. restaurants) and are produced in whole or in part from GM soya beans (Decision 96/281/EC) and GM maize (Decision 97/98/EC). These foodstuffs are subject to labelling requirements in addition to those in Directive 79/112/EEC.

The labelling requirements do not apply when the protein or DNA resulting from the genetic modification is not present in the food ingredients individually considered or the food when it comprises a single ingredient (art. 2(2)(a)). In addition, labelling is not required where the foodstuff contains GM soya beans and/or GM maize and any other material placed on the market pursuant to Regulation 258/97 (Novel Foods and Food Ingredients) derived from GMOs in a proportion no higher than 1 percent of the food ingredients (art. 2(2)(b)). In other words, de minimis amounts of genetically modified materials up to 1 percent do not trigger additional labelling requirements. Operators must be in position to supply evidence to satisfy competent authorities that they have taken appropriate steps to avoid GMOs as a source.

Lists of products, ingredients or foods without DNA or protein from genetic modification, and therefore not subject to additional labelling requirements, are to be developed taking account of technical developments, the opinion of the EC Scientific Committee for Food and other relevant scientific advice (art. 2(a)).

Additional labelling requirements vary with the form the food product takes. For example, where the food consists of more than one ingredient, the words “produced from genetically modified soya” or “produced from genetically modified maize” are to appear in the list of ingredients in brackets immediately after the ingredient concerned or in a prominently displayed footnote (art. 3(a)). Other requirements apply (art. 3(b)-(d)).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Regulation 50/2000/EC (Labelling of Foodstuffs and Food Ingredients Containing GM Additives and Flavourings)


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Selected Legal Annotations and Comments

Regulation 50/2000 fills in a gap created by Regulation 258/97 (Novel Foods and Food Ingredients) because it does not apply to GM additives and flavourings. Regulation 50/2000 applies to additives and flavourings used in foodstuffs that are, contain or are produced from GMOs (art. 1(2)).

Labelling requirements in addition to other Community labelling requirements are to be specified for additives and flavourings to ensure that the final consumers and mass caterers are informed. Among these, additional labelling is required when (a) any characteristic or food property no longer renders a novel food or food ingredient equivalent to an existing counterpart (based on scientific assessment and accounting for natural variations); (b) material that is present that is not present in the existing counterpart and which may have human health implications for certain population sectors; (c) the presence of material not found in existing counterparts gives rise to ethical concerns; and (d) GMOs are the present (art. 2(a)-(d)).

Additives or flavourings are not equivalent if scientific assessment demonstrates that the characteristics assessed are different to traditional additives or flavourings taking into consideration accepted limits for natural variation (art. 3). Additives or flavourings with protein or DNA resulting from genetic modification are not considered equivalent. The labelling requirements vary with the form of the flavouring or additive. They may include wording such as “produced from genetically modified...” (where a characteristic or food property is not equivalent to existing additives or flavourings) (art. 4(1)) or “genetically modified” (where an additive or flavouring is or contains an organism modified by GM techniques (art. 4(2)).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Proposed Regulation on Genetically Modified Food and Feed

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Selected Legal Annotations and Comments

The Proposed Regulation of the European Parliament and the European Council on Genetically Modified Food and Feed flows from various proposals made in the Commission White Paper on Food Safety (COM (1999) 719 Final, 21 January 2000) and the adoption of Directive 2001/18/EC.

The proposed regulation will consolidate existing Community level legislation and procedures on these issues and close gaps such as feed produced from GMOs and the evaluation of genetic modifications in additives and flavourings. The proposed regulation is premised on three fundamental objectives: (1) to ensure a high level of consumer and animal health and life protection; (2) to facilitate the consumer’s and in the case of feed, the end user’s right to know to enable an informed choice; and (3) to ensure that the consumer or end user is not misled (CEC, 2001).

The proposed regulation would fit within a larger framework of food law that is being proposed for a regulation at the Community level in the aftermath of European food crises involving BSE and dioxin contaminated feed (see EC proposed regulation COM (2000) 716 Final - 2000/0286(COD)). The proposed legal framework would lay down general principles and requirements of food law, establish an independent European Food Authority and provide procedures for food safety. It will include a proposed regulation on traceability and labelling of GMOs and traceability of food and feed products produced from GMOs. The European Food Authority would carry out the role of scientific committee envisioned in existing EU legislation (CEC, 2001). For example, the Authority would undertake risk assessments on GM food and feed under the proposal described here.

The overall process envisioned is based on the “one door-one key” principle (CEC, 2001). This would streamline procedures and make it possible for an applicant to obtain approval for both the deliberate release of a GMO as well as its use in food and/or feed in one process. There would be a single risk assessment process overseen by the Authority. There also would be a single risk management process involving the Commission and the Member States (CEC, 2001).

The proposed regulation would cover genetically modified food, livestock feed and additives and flavourings regardless of whether DNA or protein resulting from the genetic modification can be detected (CEC, 2001). In other words, it will apply to products produced from a GMO, rather than products produced with a GMO (CEC, 2001). According to the explanatory memo accompanying the proposed regulation, the determining criterion is whether or not material derived from the genetically derived starting material is present in the food or in the feed. Also the memo states that food or feed manufactured with the help of a genetically modified processing aid is not covered.

Importantly, the proposed regulation would eliminate the simplified notification procedure provided in the Novel Foods Regulation (97/258/EC) for GM foods which are “substantially equivalent” to existing foods. According to the explanatory memo accompanying the proposal, the substantially equivalent concept has been controversial in the Community. It has been recognized internationally only as a key step in the safety process of GM foods but not a safety assessment in itself has it has been used as a regulatory shortcut. The references in the proposed Regulation to “other legitimate factors” indicates that the Commission, as decision maker, may in making its decision rely on other factors in addition to the scientific risk assessment undertaken by the Authority and provided for in the authority’s written opinion. The reference may align the EU legislation with work being undertaken in the Codex Alimentarius Commission.

The Commission’s proposal on regulating genetically modified food and feed has been supported by the European Parliament in July 2002. In November 2002 the Council has adopted its Common Position.

Genetically Modified Food (Chapter II)

Authorization

The proposed regulation would apply to (1) GMOs for food use (GMOs used as food or as source material - article 2(4)), (2) food containing or consisting of GMOs and (3) food produced from or containing ingredients produced from GMOs (art. 3). The criteria for authorization require that the food must not: (1) present a risk to human health or the environment; (2) mislead the consumer; and (3) differ from food that it is intended to replace to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer (art. 4(1)). “Genetically modified food or feed” means “food or feed containing, consisting or produced from [GMOs]” (art. 2(3)). Marketing a genetically modified organism for food use or food requires prior authorization (art. 4(2)). Authorization requires the applicant to demonstrate that the organism for food use or food meets the article 4(1) criteria. In other words, the applicant has the burden of demonstrating the safety of the organism or food. Authorization may apply to (1) a GMO or foods containing or consisting of that GMO, as well as foods produced from or containing ingredients produced from that GMO or (2) a food produced from or containing an ingredient produced from a GMO as well as foods produced from or containing that food (art. 4(4)).

Food material that contains, consists of or is produced from GMOs in proportions of 1 percent or less does not require authorization (art. 5). However this is provided (1) the presence is “adventitious or technically unavoidable” and (2) the GM material has been subject to scientific risk assessment by the “relevant Scientific Committee(s)” or the European Food Authority. The assessment must conclude that the material does not present a risk to human health or the environment. Operators “must be in a position” to show “competent authorities” that the material is adventitious or technically unavoidable by demonstrating that they have taken steps to avoid the presence of the GMO or the products thereof.

An application process would be established by the proposed regulation (art. 6). The application would be sent to the Authority. Along with a variety of other information, including a study demonstrating compliance with the authorization criteria in article 4(1), the application must include six additional points. These are inter alia (1) either an analysis that the food is not different to conventional food compared to the criteria enumerated in article 14(2)(a) (i.e. regarding composition, nutritional value or effects, intended food use and implications for the health of certain population sections) or a proposal for labelling in harmony with article 14(2)(a) and (3), (2) either a reasoned statement that the food does not give rise to ethical or religious concerns or a proposed labelling scheme, (3) a method to detect and identify the transformation event in the food and/or in the foods produced from it, (4) food and control samples, (5) where appropriate a post-market monitoring proposal and (6) a dossier summary (art. 6(3)(f), (g), (i)-(l)).

The Authority would consider the application and would prepare an opinion that is subsequently considered by the Commission and the Member States (art. 7). The Authority would make the application and supplementary information available to the Commission and the Member States (art. 7(3)(b)). The applicant’s dossier summary would be made available to the public (art. 7(3)(c)). The Authority may ask a food assessment body in a Member State to undertake a food safety assessment and a competent authority designated under Directive 2001/18/EC to undertake an environmental risk assessment (art. 7(3)(d)). Confusingly, the Commission will publish a recommendation on the nature of the risk assessment that the Authority is to undertake (art. 7(8)). The Authority may also request the Community reference laboratory to test and validate the detection and identification methods proposed by the applicant (art. 7(3)(f)). The Authority would also validate the applicant’s claims that the food’s characteristics are different from its conventional food counterpart (art. 7(3)(g)).

The Authority’s evaluation must respect the environmental safety requirements specified in Directive 2001/18/EC for GMOs or food containing or consisting of GMOs in relation to deliberate release or placing the product on the market (art. 7(4)). The Authority is to consult with the bodies set-up under Directive 2001/18/EC by the Community and /or the Member States. Favourable opinions by the Authority are to include inter alia a labelling proposal, any conditions or restrictions such as post-market monitoring based on the risk assessment and a detection method (art. 7(5)). The Authority would forward its opinion to the Commission and the Member States with a rationale (art. 7(6)). The opinion would also be made available to the public after deletion of confidential information (art. 7(7)). The public will be able to provide the Commission with comments within 30 days of the opinion’s publication. There are no criteria proposed on the extent to which public comments need to be considered.

The Commission will prepare a draft decision. The draft decision is to take account of Community law and “other legitimate factors relevant to the matter under consideration” (art. 8(1)). A draft decision contrary to the Authority’s opinion will need to provide an explanation of the differences. A final decision will be adopted according to Decision 1999/468/EC. Authorization is valid for 10 years throughout the Community (art. 8(5)). The authorized food is entered in a Register that is accessible to the public. Products authorized before the entry into force of the Regulation could remain on the market subject to a notification to the Authority which will include the information required in a first time notification described earlier under article 6(3) and (5) (art. 9(a)). The process will lead to the product being placed on the Register (art. 9(b)).

All authorization holders will have supervisory obligations to undertake post-market monitoring and report to the Authority (art. 10(1)). The Authority will be informed of new scientific or technical information that may influence the food’s safety evaluation and will be informed of any prohibition or restriction imposed by the competent authority of a third country in which the food is placed on the market (art. 10(3)).

According to the environmental assessment of the proposed regulation, GM food labelling within the EU is currently addressed by Regulation 258/97/EC (Novel Foods and Novel Food Ingredients) and Regulation 1139/98/EC (Compulsory Indication of the Labelling of Certain Foodstuffs Produced from GMOs Other than Those Provided for in Directive 79/112/EEC) as amended by Regulation 49/2000/EC and Regulation 50/2000/EC (Labelling of Foodstuffs and Food Ingredients Containing Additives and Flavourings that have been Genetically Modified or have been Produced from GMOs). The last three regulations would be repealed by the proposed regulation described here.

It is important to note that the labelling requirements exist irrespective of the detectability of DNA or protein resulting from the genetic modification in the final the products (CEC, 2001).

Labelling

All products subject to the authorization under the proposed regulation would also be subject to mandatory labelling (CEC, 2001). Under the proposal, labelling requirements will apply to foods “delivered as such to the final consumers or mass caterers which (1) consist or contain GMOs or (2) are produced from or contain ingredients produced from GMOs (art. 13(1)). Labelling requirements will not apply to foods with material that contains, consists of or is produced from GMOs in a proportion no higher than the thresholds to be established provided the presence is adventitious or technically unavoidable (art. 13(2)). This leaves open the possibility that labelling requirements may apply to a threshold of adventitious materials different than that set for authorization. As with the procedures for GMO food authorization, the operator must be in a position to supply evidence to satisfy the competent authorities that they have taken steps to avoid the presence.

The food labelling requirements vary with the form of the product and are not to prejudice other Community labelling requirements (art. 14(1)). Generally, the words “genetically modified” or “produced from genetically modified [name of organism] but not containing a [GMO]” must appear (art. 14(1)(a-c)). Food without pre-packaging must have similar wording displayed on or in connection with the food’s display (art. 14(1)(d)). The labelling must also mention any characteristic or property when (1) the food is not equivalent to its conventional counterpart (i.e. with regard to composition, nutritional value or nutritional effects, intended use, or implications for the health of certain sectors of the public) or (2) where the food gives rise to ethical or religious concerns (art. 14(2)(a) and (b)). Where a food does not have a conventional counterpart the label is to include information about the food’s nature and the characteristics (art. 14(3)).

Genetically Modified Feed (Chapter III)

The proposed regulation’s provisions on genetically modified feed (marketing and labelling) generally parallel the provisions for genetically modified food. The following recounts some highlights.

Directive 90/220/EEC and, when it enters, into force 2001/18/EC, presently regulate GM feed. Feed produced from GMOs but which does not contain them does not have to be labelled presently. The proposed regulation would change this.

The authorization procedure is the same as that for GM food. The proposed regulation will apply to (1) GMOs for feed use, (2) feed containing or consisting of GMOs and (3) feed produced from GMOs (art. 16(1)). To gain authorization, feed must not (1) present a risk to animal health, human health or the environment, (2) mislead the user, (3) harm the consumer by impairing the distinctive features of animal products and (4) differ from feed it was intended to replace to such an extent that it would be nutritionally disadvantageous for animals or humans (art. 17(1)). The authorization can apply to (1) a GMO and feed containing or consisting of that GMO as well as feed produced from the GMO or (2) feed produced from a GMO as well as feed produced from or containing the feed (art. 17(4)).

A 1 percent threshold is set for adventitious or technically unavoidable genetically modified material in feed with similar conditions shifting the burden on the operator to be in a position to demonstrate the steps taken to avoid the presence (art. 18). The application for authorization also refers to information (1) demonstrating the feed is not different than a conventional feed, (2) a reasoned statement that the feed does not give rise to ethical or religious concerns and (3) a method to detect and identify the transformation (art. 19(3)(f), (g) and (i). The Authority will conduct the application review and submit an opinion to the Commission and Member States with distribution to the public (art. 20(3)(b) and (c)). The Commission will publish a recommendation on the nature of risk assessment that the authority will undertake (art. 20(8)). In developing its draft decision the Commission is to take into account Community legislation and “other legitimate concerns” (art. 21(1)). It will also include the unique code attributed to the GMO to be developed further under the proposed regulation on traceability and labelling (art. 21(2)). Authorization will be valid for 10 years throughout the Community (art. 21(5)).

In contrast to the GM food labelling requirements which only speak in terms of label content, article 27 proscribes a person from marketing GM feed without including a clearly visible, legible and indelible label, either on an accompanying document or on the packaging, container or on a label attached thereto (art. 27(3)). For genetically modified feed the name shall be “genetically modified [name of feed]”; for feed produced from GMOs: “produced from genetically modified [name of the feed from which the feed is produced] but not containing a [GMO]”; for feed containing or consisting of GMOs the unique identifier assigned to the GMO shall accompany the name of the feed (art. 27(3)(a(and (b)). As with the GM food labelling requirements, any characteristic not equivalent to its conventional counterpart needs to be also clearly indicated, including a characteristic or property that may give rise to ethical or religious concerns (art. 27(3)(c) and (d))

Common Provisions

Products likely to be used as food and feed shall be evaluated as a single application and will result in a single opinion by the Authority (art. 29). A Community Register of Genetically Modified Food and Feed is to be created and made available to the public (art. 30). Confidentiality provisions are similar to those in 2001/18/EC. However, it is clarified that the Commission, Authority and the Member States are obliged to keep confidential all information identified as confidential “except for information which must be made public if circumstances so require, in order to protect human health, animal health or the environment” (art. 31(5)). The Community Reference Laboratory will be the Commission’s Joint Research Centre (Annex). It will be assisted by a consortium of national reference laboratories to be referred to as the “European Network of GMO Laboratories”. As with Directive 2001/18/EC, at its own initiative, or upon request of a Member State, the Commission may also consult the European Group on Ethics in Science and New Technologies to obtain its opinion on ethical issues (art. 34(1)). The Commission will make the Group’s opinions available to the public (art. 34(2)).

In addition to that European legislation already mentioned, the proposed regulation would amend Regulation 258/97/EC (Novel Foods). It would do this by removing GM foods from its scope of application (art. 38); Directive 82/471/EEC (Concerning Certain Products useful in Animal Nutrition) would be amended by removing products which act as direct or indirect protein sources that are within the scope of application of the proposed regulation (art. 39); Directives 70/457/EEC (Common Catalogue of Varieties of Agricultural Plant Species) and 70/458/EEC (Marketing of Vegetable Seed) would be amended inter alia such that when the material derived from a plant variety is intended to be used in food within the scope of the proposed regulation, the variety will not be accepted unless it is approved in accordance with the proposed regulation (art. 40(1) and article 41(1)); Directive 2001/18/EC would be amended with regard to the 1 percent threshold for adventitious presence of GMOs in products (art. 42).

France

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Law 92-654 (Control of GMO Use and Spread) (1992)

Y

Y




Y



Y

Y

Y

Y


Selected Legal Annotations and Comments

Law 92-654 is the basic French law for research on and release of genetically modified organisms as they may affect the environment or human health. Title I provides for the National Commission on Gene Technology, a cross-sectoral body composed of scientists in fields related to genetics, public health and environmental protection and a representative from Parliament (art. 3(I)). It is charged with evaluating risks posed by GMOs and proposes risk management measures. It also proposes necessary measures to adapt to technological changes. The National Commission on the Release of the Biomolecular Products is another cross-sectoral body involved with the risk assessment, defining the conditions of commerce and labelling of GMOs and the products that contain them (art. 3(II)). It is composed of scientists, parliamentary members, representatives of environmental and consumer protection groups, professionally concerned groups and representatives of employee groups. A simple reading of the law does not give the reader a clear indication of the roles of these two institutions. Subsequent legislation described below indicates that the National Commission on the Release of the Biomolecular Products generally undertakes the risk evaluation. It undertakes the risk evaluation and supplies an opinion to the Minister of the relevant competent national authority reviewing the application for authorization.

Title II applies to GMOs used in research applications. GMOs are classified according to risk (art. 4). A license is required for GMO research (art. 6(I)), except where the GMO is a non-disease causing organism or has been classified as not dangerous to public health or the environment (art. 6(II)). The license includes risk management measures (art. 6(I)).

The application for first time authorization is to include an “information file to the public” (art. 6(II) including general information on the planned activities, the classification of the GMOs and an address where the public can file objections. The address is that for the National Commission on Gene Technology. In general, the file is sent to and reviewed by the competent national authority responsible for the application’s authorization, which may vary with the type of organism or product. Subsequent legislation described below clarifies which competent national authority is involved. In addition, the file must be sent to the local administration, mayor or city hall where the activity will take place. It is unclear whether this is purely for informational purposes or whether another regulatory process takes place at the local level. There are no other specific provisions on stakeholder involvement, but the information file submitted by the applicant must include an address to which the public can file objections to the proposal (art. 6(II)).

Decree 93-773 describes the general administrative procedures and the conditions under which authorization can be granted under Law 92-654. In particular, article 3, as amended by Decree 98-18, classifies the genetically modified organisms in two groups, according to classes of risk and other criteria, such as nature of the vector or transmitted DNA sequence. Decree 93-773 sets out provisions on information to the public on possible risks and emergency plans. In general, the proposer makes an application to the appropriate competent authority. As described above, a public notice at the local level (e.g. at the city hall) is to inform the public about the request (art. 7(II)).[6] Comments are made to the competent authority and the proposer then must address them.

Title III applies to GMOs deliberately released into the environment for research or development purposes and GMOs placed into commerce. It does not apply to GMO transport (art. 9). All releases and related research, as well as placement into commerce, require a permit (arts. 11 and 15). Permission is based inter alia on a risk evaluation (arts. 11 and 15). The public has the right to access all files related to risk to public health or the environment (art. 12), but it is unclear how stakeholders can actually participate in this aspect. The application file must include an address to which the public can file objections to the proposal as described earlier (art. 6(II)). Commerce in GMOs requires a license. “Commerce” is defined as putting genetically modified products or products with GMOs at the disposal of third parties for free or for a fee (art. 14).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Decree 93-1177 (Application of Law 92-654 to GM Plants, Seeds and Seedlings) (1993)

Y

Y




Y



Y

Y

Y

Y


Selected Legal Annotations and Comments

The Ministry of Agriculture is the competent national authority that provides authorization to release GMOs related to plants, seeds and seedlings, after approval of the Ministry of Environment (art. 1). In addition to other information for the application, an information file for the public must be included. This is to include information on inter alia: goal of release, description of GMO; evaluation of risks and impact on human health and the environment; and emergency plans (arts. 2-11). The National Commission on the Release of the Biomolecular Products undertakes a risk evaluation and provides its opinion to the Minister who then makes a decision (arts. 2 and 3).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Decree 94-359 (Control of Phyto-pharmaceutical Products)(1994)

Y

Y



Y

Y




Y

Y

Y


Selected Legal Annotations and Comments

Phyto-pharmaceutical products include all substances, preparations containing active ingredients and products composed wholly or partially of GMOs for use inter alia as herbicides, pesticides or fertilisers (art. 1). Deliberate release or commerce in GMO phyto-pharmaceuticals requires a license issued by the Ministry of Agriculture after approval from the Ministry of Environment (art. 29). Information requirements are similar to those outlined in the previous decree and the main law, including various pieces of information for public information (art. 30). The National Commission on the Release of the Biomolecular Products undertakes a risk evaluation and provides its opinion to the Minister who then makes a decision (arts. 29, 46 and 49). When the Ministry of Agriculture authorizes the release, it provides information to the local community where the release will take place, though it is unclear to what extent local approvals apply (art. 54). Labelling requirements are to follow the requirements laid out in an administrative order from 21 September 1994 (art. 64-66).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Decree 95-487 (Applications for GM Animals) (1995)

Y

Y


Y


Y




Y

Y

Y


Selected Legal Annotations and Comments

Release of genetically modified animals must be authorized by the Ministry of Agriculture after the approval of the Ministry of the Environment (art. 2). Application information requirements are similar to earlier decrees, including a public information file (art.3). Similar authorization is required for commerce in GM animals (arts. 13-19). Authorization in either case cannot be made if the GM animal and its descendants cannot be traced (art. 22). Animals must be kept under surveillance for diseases and behaviour. The minister will grant authorization after the opinion and risk evaluation of the National Commission on the Release of Biomolecular Products (art. 3(III)).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Decree 97-685 (Animal Feed Stuff) (1997)

Y

Y




Y




Y

Y

Y


Selected Legal Annotations and Comments

Chapter I provides rules for the release (testing) of products destined for animal feed composed partially or wholly of GMOs which are not plants, seeds seedlings or breeding animals. Release is permitted by a joint ministerial order issued from the Ministry of Consumer Protection and the Ministry of Agriculture after approval from the Ministry of Environment (art. 1). Application information requirements are similar to decrees described earlier including a public information file (art. 2(II)). The public may address all observations about the release to the Ministry of Consumer Protection. Upon a complete application, the Ministry of Consumer Protection submits the application to the National Commission on the Release of the Biomolecular Products and the National Commission on Animal Feed. The Commissions give their opinions to the Minister, based on a risk evaluation, who then decides to grant consent or reject the file (art. 3(II)).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Decree 98-318 (Control of Fertilisers and Cultivation Supporting Substances Wholly or Partially Containing GMOs) (1998)

Y

Y




Y




Y

Y

Y


Selected Legal Annotations and Comments

Release of or commerce in fertilisers and cultivation supporting substances partially or wholly composed of GMOs requires Ministry of Agriculture authorization after approval by the Ministry of the Environment (arts. 1 and 16). The National Commission on the Release of Biomolecular Products and a number of other commissions is involved in the review process and they provide their opinions to the Minister (arts. 1 and 16). Information requirements in the application are similar to those for other decrees (art. 2(III)). Commerce will be authorized when the product is (1) shown to be harmless to public health and the environment and effective and (2) if no EU country opposes the application (art. 17(I)).

United Kingdom

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Environmental Protection Act (1990) as amended

Y





Y



Y

Y

Y

Y


Selected Legal Annotations and Comments

Part VI of the UK Environmental Protection Act, as amended, and The Genetically Modified Organisms (Deliberate Release) Regulation (1992), as amended, implement EC Directive 90/220/EEC (Deliberate Release and Marketing of GMOs). The designated Secretary of State from England, Wales and Scotland act to implement the legislation. Where a function of the Secretary of State is exercised in relation to a matter where the Minister of Agriculture, Fisheries and Food has competence the function is to be exercised acting jointly (as respects England)(sect. 126).

No person may import, acquire (to be in a person’s possession (sect. 217(1)), keep, release or market GMOs unless (1) a risk assessment of damage to the environment is carried out from the act and (2) the Secretary of State has been notified (sect. 108(1) and (3)). The Secretary of State may decide when consent is required by giving directions (sect. 108(8)). General duties of a person proposing to import, acquire, release or market GMOs or who is keeping GMOs vary with the circumstances (sect. 109). They include inter alia: (1) taking reasonable steps to identify the risks of damage to the environment when proposing to import or acquire GMOs and not importing or acquiring GMOs when there appears to be risk of damage to the environment, despite precautions taken (sect. 109(2)); (2) keeping informed of environmental damage caused by keeping GMOs, identifying risks of environmental damage caused by continued keeping, ceasing keeping of GMOs where there is risk of environmental damage from continued keeping and using best available techniques, not entailing excessive costs, to keep GMOs under control and preventing any environmental damage and disposing of GMOs properly; and (3) keeping informed of the risks of environmental damage as a result of GMO release, not releasing when there is a risk of environmental damage and using best available techniques, not entailing excessive costs, to prevent any environmental damage (sect. 109(2-4)).

No person can import, acquire, keep, release or market a GMO without the consent of the Secretary of State (sect. 111(1) and (2)). Application requirements apply (sect. 111(3)). The application must also be advertised (sect. 111(4)) and must be advertised to such persons as may be prescribed (sect. 111(5)). Exemptions are possible (sect. 111(7)). The Secretary of State may, by notice, revoke or vary the consent at any time (sect. 111(10)). In addition to specific conditions applied to the consent (sect. 112), every consent includes implied general conditions applicable to the consent holder. These vary with the circumstances. The implied general conditions parallel the general duties described earlier. They generally include (1) keeping informed of any risks of environmental damage from the permitted activity, (2) notifying the Secretary of State of any new information regarding the risks of environmental damage being so caused and the effects of any releases especially those when it appears the risks are more serious than apparent when the consent was first granted and (3) using best available techniques, not entailing excessive costs, to prevent environmental damage as a result of the activity (sect. 112 as amended by reg. 9 of 1992)).

The Secretary of State is to maintain a public register. The register includes (1) notifications under section 108, (2) directions under section 108(8), (3) prohibition notices, (4) applications for consent and advice given by an appointed committee, (5) consents granted and information furnished pursuant to conditions of consent, (6) any other information and (7) convictions for offences (sect. 122(1)). The register is to be open to the public, free of charge and is to afford the public facilities to obtain copies of register entries for reasonable charges (sect. 122(2)). The register shall not include (1) information contrary to national security interests, (2) information that could lead to environmental damage or (3) information that is commercially confidential (without consent of the information holder (sect. 123(1-3)). The register goes beyond EU requirements.

The holder of commercially confidential information must apply to have the information excluded from the register (sect. 123(4)) and the Secretary of State decides upon the application and informs the applicant accordingly. When it has been obtained as a result of the law’s implementation, the Secretary of State shall notify third parties of information that may be commercially confidential to give them a reasonable opportunity to object to its posting in the register (sect. 123(6)). The Secretary of State shall take the third party’s representations into consideration before determining whether the information is commercially confidential. Information to be included in the register for notifications, consent applications and consents granted is to include (1) name and address of person; (2) GMO description; (3) location of the GMOs; (4) purposes of importation, acquisition, keeping, release or marketing; (5) results of environmental risk assessment; and any other information “which the public interest requires” notwithstanding its commercial confidentiality (sect. 123(7)(a)-(e)). Confidential information can be excluded from the register for up to four years, at which time the holder needs to reapply (sect. 123(8)).

The Secretary of State is to appoint a committee to provide advice inter alia on consents and conditions and limitations on consents (sect. 124). The Advisory Committee on Releases to the Environment has been established and consists of independent experts. It advises the government on the safety of proposed releases and marketing of GMOs (and non-native species), biosafety research and GMO policy issues (UK Joint Regulatory Authority, et al., 2000). The Advisory Committee can take into consideration comments made as a result of listing in the public register and those made after the application has been notified in newspaper under the 1992 Regulations (see below) (UK Joint Regulatory Authority, et al., 2000).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

The GMOs (Deliberate Release) Regulation (1992), as amended

Y





Y



Y

Y

Y

Y


Selected Legal Annotations and Comments

The regulations, as amended, implement Part VI of the Environmental Protection Act of 1990. The regulations provide more detailed requirements. They are divided into different parts.

Part II deals with marketing. To streamline the regulatory process, applications for release can address (1) one or more releases of one or more GMOs “of one or more descriptions” on the same site for the same purposes or (2) one or more releases of one description of GMOs on one or more sites for the same purposes (reg. 5(2)).

The applicant is responsible for advertising the application for consent to release by publishing a notice in a newspaper or newspapers in the areas likely to be affected by the proposal (reg. 8(1)). The information is to include (a) the applicant’s name and address; (b) the general description of the organisms to be released; (c) the release’s location and general purpose; and (d) the foreseen release dates (reg. 8(1)(a)-(d)). The level of detail regarding the release’s location must be that which appears in the public register created pursuant to the Environmental Protection Act. In addition, the applicant must specifically notify a number of individuals that he has made the application along with the information found in the public notice. These include inter alia (a) the owner or owners of the site when different from the applicant; (b) the local authority for the area of the proposed release; (c) the Nature Conservancy Council (England), Scottish Natural Heritage or the Countryside Council (Wales); (d) the Countryside Commission (England); (e) the Forestry Commission; (f) the National Rivers Authority or the regional islands council (Scotland); the water undertaker for the area of the proposed release or the river purification board or islands council (Scotland); and (g) each member of the genetic modification safety committee that the applicant has established pursuant to the UK Genetically Modified Organisms (Contained Use) Regulations of 1992 (reg. 3(a)-(h)).

Under Part III for marketing, consent for marketing is required where the product is being marketed for the first time and where the product is intended for a use for which it had not previously been marketed (reg. 10(2)). In contrast to an application for consent to release, applications for consent to market do not appear to have detailed regulations on public announcement.

Part IV enumerates various duties that are created after an application for consent is made. For example, the applicant’s duties are listed in the Act but have been expanded to include notifying the Secretary of State before the application is granted or rejected of any new information to any risks of environmental damage from release or marketing (reg. 13). With regard to consents to release, the Secretary of State’s duties include inter alia (1) forwarding the application’s summary to the European Commission (reg. 14), (2) evaluating the risks posed by the proposed release, (3) carrying our tests and inspections as necessary for control purposes, (4) where appropriate, taking account of any comments made by the competent authorities of Member States and (5) recording his conclusions in writing (reg. 14). The Secretary of State may not grant consent to release as it relates to human health without the agreement of the Health and Safety Executive (reg. 15(1)) and likewise may not revoke or vary consent as it relates to human health without the Executive’s agreement (reg. 15(5)). Consents must be notified to the European Commission and the competent authorities of the Member States (reg. 15(4)).

Consent for marketing also entails duties for the Secretary of State. These include forwarding to the Commission inter alia (1) a statement of the conditions under which the Secretary of State proposes to consent to marketing, (2) details of any proposal by the applicant not to comply with certain information requirements (where acceded to by the Secretary of State) and (3) a favourable opinion (reg. 16(2)(a)) or informing the applicant that the application does not fulfil the necessary legal requirements (reg. 16(2)(b)). Favourable opinions must be forwarded to the Commission only with the agreement of the Health and Safety Executive (reg. 16(3)). Information received before or after consent is made is to be forwarded before or after granting consent (reg. 16(5)). The Secretary of State will grant consent where the Commission has taken a favourable decision under its procedures after a Member State objects (reg. 16(7)). Revocations or variations to a consent cannot be made as they relate to human health cannot be made without the agreement of the Health and Safety Executive (reg. 16(8)).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Novel Foods and Novel Food Ingredients Regulations (1997) as amended


Y

Y


Y

Y



Y

Y

Y


Y

Selected Legal Annotations and Comments

Pursuant to the Food Safety Act of 1990, these regulations enable the enforcement and execution of certain obligations of EC Regulation 258/97/EC and other EC regulations. In the UK, requests to place a novel food or novel ingredient on the market (pursuant to article 4(1) of Regulation 258/97/EC) are made to the Minister of Agriculture, Fisheries and Food who acts jointly with the Secretary of State for Health as the UK food assessment body (reg. 3). However, these powers appear to be delegated to individual food authorities, designated by the UK Food Safety Act and operating at the local level, who are responsible when designated to enforce or execute the EC regulation. Therefore, separate but similar regulations have been promulgated for England, Northern Ireland and Wales.

For example, the Genetically Modified and Novel Foods (Labelling) (England) Regulations 2000 implement the details of the EC regulations dealing with novel foods and food ingredients involving GMOs. It specifies inter alia: the general and specific requirements for the manner of marking or labelling foods and food ingredients, including additives and flavourings, containing GM maize and soya. Offences and penalties are also specified.

It is not immediately apparent from the regulations reviewed how the process to make the initial assessment under Regulation 258/97/EC to market novel foods and novel ingredients operates within the UK. However, though not specifically referred to in the regulations, the Advisory Committee on Novel Foods and Processes (ACNFP) carries out the assessment of novel foods in the UK, The ACNFP is a non-statutory body of independent experts (UK Food Standards Agency, a.).

A 1999 amendment to the Regulations increased the transparency of ACNFP’s proceedings such that any information submitted to it under the European Commission Regulation 257/97 is discloseable to anyone who requests it. This is subject to three exceptions: (1) the information is not required by the EC Novel Foods Regulation; (2) ACNFP agrees with the information holder that the information is confidential because it would harm competitive position; or (3) the ACNFP agrees that the information is confidential because disclosure would harm intellectual property rights (UK Food Standards Agency, Other aspects of stakeholder involvement such as public participation in decision-making are not clarified, although another UK law that has not been reviewed, such as the UK Freedom of Information Act (2000), could provide for this.

The UK Food Standards Agency, created pursuant to the Food Standards Act of 1999, provides the ACNFP’s secretariat.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Food Standards Act (1999)


Y

Y


Y

Y




Y

Y

Y


Selected Legal Annotations and Comments

The Food Standards Agency is entrusted with protecting the public from risks that may arise from food consumption and to protect the interests of consumers with respect to food (sect. 1(2)). The risks from food consumption may include those risks caused by the way the food is produced or supplied. The Agency functions to develop food safety policies (sect. 6(a)), It also provides advice and information to the general public on food safety or other consumer related interests (sect. 7(1)), while ensuring that the public is kept adequately informed and advised in respect of matters that could significantly affect their capacity to make informed choices on food (sect. 7(2)). The Agency has similar functions with respect to animal feed stuffs (sect. 9). It is expected that the UK Food Standards Agency will eventually act as the competent authority within the UK for purposes of implementing EC Novel Foods Regulation 258/97/EC (ACNFP, 1997).

The Agency is to prepare and publish a statement of general objectives that it intends to pursue and the general practices that it intends to adopt to carry out its functions (sect. 22(1)). The statement is to include as one of the Agency’s objectives “securing that its activities are the subject of consultation with, or with representatives of, those affected and, where appropriate, with members of the public” (sect. 22(2)(a)). The statement is also to include as one of the Agency’s objectives “securing the records of its decisions, and the information upon which they are based, are kept and made available” to enable the public to make informed judgments about the manner in which the Agency carries out its functions (sect. 22(2)(c)).

When it carries out its functions, the Agency is to “pay due regard” to its statement of objectives (sect. 23(1)). When it considers whether or not to exercise its powers, or the manner in which it will exercise any power, the Agency is to take into account inter alia (1) the nature and magnitude of the risks to public health or other risks relevant to the decision (including “any uncertainty as to the adequacy or reliability of available information”), (2) the likely costs and benefits of the exercise and non-exercise of its powers and (3) “any relevant advice or information...[from] an advisory committee (whether or not requested) (sect. 23(2)(a)-(c)).

South West Pacific

Australia

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Gene Technology Act (2000)

Y





Y

Y


Y

Y

Y

Y

Y

Selected Legal Annotations and Comments

The Australian Gene Technology Act consolidates Australia’s treatment of GMOs (e.g. an (living) organism modified by gene technology or an organism that that has inherited a gene technology derived trait from another organism - sect. 10) and GM products (i.e. a thing, other than a GMO, derived or produced from a GMO - sect. 10). The object of the Act is to (1) protect human health and safety and (2) protect the environment by identifying and managing risks posed by gene technology, by regulating “certain dealings” (i.e. activities) with GMOs (sect. 3). The Act has been supplemented by regulations (Gene Technology Regulations 2001). The objectives of the Act are achieved through a regulatory framework. The framework is premised inter alia on the precautionary principle: “where there are threats of serious or irreversible environmental damage, a lack of full scientific certainty should not be used as a reason for postponing cost-effective measures to prevent environmental degradation” sect. 4(aa). The term “precautionary principle” is not used and it is unclear whether this is a policy principle for purposes of the Act (see below).

The Act is viewed as a component of a nationally consistent scheme to regulate certain dealings with GMOs (sect. 5). The Act works in conjunction, with and does not substitute for, other Commonwealth and State regulatory schemes relevant to GMOs and GM products (sect. 4(b)). In effect, this means that the Act applies to all dealings listed, including imports or intentional releases into the environment, and applies to those GM products not already regulated by an existing Australian agency. For example, food products with GM components and foods that are GMOs are regulated according to existing food laws in particular the Australia New Zealand Food Authority Act (1991) and accompanying standards. Similar treatment is accorded to agriculture and veterinary chemicals, industrial chemicals and therapeutic goods. Being a commonwealth, State laws are not displaced by the Act to the extent that they are compatible with it (sect. 16).

The Act establishes the Gene Technology Regulator as an administrative office within the Ministry of Health and Aged Care to administer the legislation and make decisions pursuant to it (sect. 26). Among its functions, the Regulator performs functions in relation to issuing GMO licences, develops draft policy principles and codes of practice and provides advice to the public, other regulatory agencies and the Ministerial Council (sect. 27).

The Act also establishes (1) a scientific committee (Gene Technology Technical Advisory Committee), (2) a community committee (Gene Technology Community Consultative Committee) and (3) an ethics committee (Gene Technology Ethics Committee) (part 8). The committees are interdisciplinary and share cross membership. On matters within their competence, the committees provide advice upon request to the Regulator and the Ministerial Council. Common to all three committees is inter alia providing advice on the need for policy principles and codes of practice. In particular, the Ethics Committee is to provide advice on ethical issues relating to gene technology, the need for and content of codes of practice in relation to ethics and conducting dealings with GMOs and the need for a content of policy principles in relation to dealings with GMOs that should not be conducted for ethical reasons (sect. 112). All committee members are subject to disclosure and conflict of interest rules.

The Act prohibits persons from dealing (e.g. research, manufacture, production, commercial release and import) with GMOs unless the dealing is (1) exempt, (2) a “notifiable low risk dealing” (NLRD), (3) on the Register of GMOs or (4) licensed by the regulator. Offences can be penalized criminally and can be considered strict liability offences. The licensing system that is created applies to two kinds of dealings - those involving intentional release into the environment and those that do not (sect. 39). Applications are made to and reviewed by the Regulator. For those applications where the dealings do not involve release, the Regulator must inter alia prepare a risk assessment and risk management plan (sect. 47, para. 1). Criteria are provided for undertaking both the assessment and the management plan (sect. 47, paras. 2 and 3). The Regulator has the discretion to consult with those entities and persons listed including the Gene Technology Technical Advisory Committee (sect. 47, para. 4).

When an intentional release is involved, and the Regulator is satisfied that it may pose significant risks to human health and safety or the environment, he must publish a notice on the application in the Official Gazette, a national newspaper and on the Regulators website (sect. 49). Criteria are provided to guide the Regulator’s determination of significant threat (sect. 49, para. 2). Criteria are also provided for the public notice including inviting submissions on whether the license should be issued along with a closing date for submissions (sect. 49, para. 3). Before a license for release can be issued the Regulator must prepare a risk assessment and a risk management plan, regardless of whether a public notice was required (sect. 50). (NB: this seems to mean that all applications for a license to release requires assessment, whether the threats foreseen are significant or not). The Regulator must also seek advice from those entities and persons listed, including the Gene Technology Technical Advisory Committee, on matters related to the risk assessment and risk management plan (sect. 50). Criteria are provided for what must be assessed. The Regulator is directed to “take into account” inter alia any risks to human health and safety and the environment, any submission made under the public notice and any advice from those entities enumerated, including the Gene Technology Technical Advisory Committee (sect. 51, para. 1). Similar criteria are specified for the risk management plan (sect. 51, para. 1). Once assessment and plan are completed, the Regulator must again notify the public that they are available for comment (sect. 52, para. 2) and again seek advice from enumerated entities (sect. 52, para. 3). The Regulator may also hold public hearings (sect. 53). Persons may request copies of the application and the risk assessment or risk management plan (sect. 54, para. 1). Confidential commercial information so declared by the Regulator is not to be shared (sect. 54, para. 2).

The applicant must apply to the Regulator for a declaration of confidential commercial information (sect. 184). Criteria are provided to guide the Regulator’s decision-making (sect. 185). The Regulator may refuse a declaration when the public interest in disclosure outweighs the prejudice disclosure would cause to the information holder (sect. 185, para. 2). The Regulator must refuse a declaration of confidential information if the information relates to one or more locations at which GMO field trials would occur, unless the Regulator is satisfied that significant damage to human health and safety, the environment or property would likely occur if the locations were disclosed (sect. 185, para. 2a). The Regulator must make publicly available a statement of reasons for making the declaration (sect. 185, para. 3(a)).

In any licensing decision - whether for release or otherwise - the Regulator cannot issue license without being satisfied that risks posed by the dealings proposed to be authorized by the license can be managed to protect human health and safety and the environment (sect. 56). Guidelines are provided to guide the Regulator’s decision-making process. For example, the Regulator must be guided by the risk assessment and management plan, submissions received from the public and any policy guidelines in force related to risks and ways to manage them (Sect. 56, para. 2). However, the Regulator must also not issue a license if it would be inconsistent with a policy principle in force or if the applicant is not suitable to hold a license (sect. 57). In general, the Act makes an implicit distinction between policy principles and policy guidelines based on the way they are developed and to be applied. Policy principles are developed and adopted by the Ministerial Council in consultation with all three advisory committees, including the Ethics Committee, and other stakeholders within and outside government (sect. 22). Decision-making must not be inconsistent with policy principles, whereas policy guidelines are to be considered. The Ministerial Council may also issue codes of practice developed by the Regulator in a consultative process with the committees and other stakeholders (sect. 24).

Low risk dealings are subject to another regulatory process based on a notification system. They don’t require a license as such. Notifiable low risk dealings cannot involve intentional release into the environment (sect. 74). Regulations are to be developed specifying low risk dealings that qualify pursuant to criteria specified: (1) biological containment and the ability of the organism to survive without human intervention; (2) minimal risk to human health and safety and the environment; (3) whether no conditions or minimal conditions would be needed (sect. 74, para. 3). These are similar to class or general licences.

The Act establishes a GMO Register, maintained by the Regulator (sect. 76). Once dealings with GMOs have been licensed for a certain period of time or a particular GMO involved is a GM product and the GMO has been defined by regulations, they may be entered into a register. GMOs can only be listed when the Regulator is satisfied that the risks posed are minimal and a person undertaking the dealing does not need regulatory oversight to protect human health and safety or the environment. Any person (sect. 81) may inspect the Register.

The Regulator must also maintain a comprehensive record of GMO and GM product dealings (sect. 138). The information in the record is to include that of designated notifications to the Regulator related to dealings involving GM products under other laws, such as the Australia New Zealand Food Authority Act (1991).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Joint Australia New Zealand Food Standards Code, Standard 1.5.2 (Food Produced Using Gene Technology) (2000)


Y

Y


Y

Y



Y

Y


Y

Y

Selected Legal Annotations and Comments

The Joint Australia-New Zealand Food Standard 1.5.2. was developed by the Australia New Zealand Food Authority (ANZFA). ANZFA develops and maintains a joint Australian New Zealand Food Standards Code pursuant to the Australia New Zealand Food Authority Act (1991). The Australian States and Territories and the government of New Zealand enforce the code and police food standards set according to it. The food standards have the force of law and must be read in conjunction with national and sub-national food legislation in the respective countries.

The Act’s objective is to ensure a high standard of public health protection throughout Australia and New Zealand through achieving inter alia a high degree of consumer confidence and the establishment of common rules for both countries (sect. 2A(a and b)). The Act created ANZFA. Among others, ANZFA’s functions include developing draft standards and draft variations of standards, to make recommendations to the joint Ministerial Council and to review standards (sect. 7(1)(a)). Any body or person may apply to ANZFA to develop a standard or variation (sect. 12(1)). After making a preliminary assessment of the application, ANZFA decides whether to accept or reject the application. If it accepts, then a full assessment is undertaken (sect. 15). When the application is accepted, a public notice must be issued (sect. 14(1)(a)) and relevant government agencies are given written notice (sect. 14(1)(b)). The public notice invites written submissions. A public hearing may be held (sect. 29).

With regard to approval, Standard 1.5.2 applies to food produced using gene technology (whether derived or developed from an organism that has been modified by gene technology - sect. 1). It does not apply to additives and processing aids derived from gene technologies, whose safety and pre-market approval, are regulated by a different standard. In general, Standard 1.5.2 prohibits the sale and use of foods produced from gene technology or classes of such foods, unless they have been assessed, approved and listed by ANZFA. Exemptions to the general prohibition on sale and use may apply. For example, if ANZFA has evidence that the food is lawfully permitted and sold or used as an ingredient or component by a food regulatory agency in one or more countries (sect. 3). The safety assessment is pursuant to ANZFA assessment criteria. Assessment generally addresses the safety for human consumption of each.

The Standard also applies to the labelling of food produced using gene technology.


[4] NB: The provisions on GMO foods and ingredients in Regulation 258/97/EC will be deleted if the Community adopts the proposal for a new Regulation on Genetically Modified Foods and Feed.
[5] NB: This Regulation and its amendments would be repealed by the proposed regulation on genetically modified food and feed.
[6] NB: in later French laws described here the public notice procedure changes slightly with the relevant competent authority, such as the Ministry of Environment or Agriculture, sending the file to the local level. The local level administration then publishes the notice at city hall. In addition, the public may send objections and observations directly to the minister. The minister then informs the National Commission on the Release of the Biomolecular Products. (Décret 93-1177 Art.6 (GM plants); Décret 94-359 Art.34 (GM phytopharmaceuticals); Décret 95-487 Art.7 (GM animals); Décret 98-318 Art.6. (GM fertilisers). Décret 97-685 is different still. Here the Minster of Commerce does not inform the concerned local administration. Instead, it publishes the public notice granting authorization in the official journal (art. 6).

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