1. NEW EU REGULATION OPENS LOOPHOLES FOR UNAUTHORISED GMOS
2. Consumer group seeks safeguards on accidental GM contamination
3. EU PROPOSALS ON GMOs PUT INDUSTRY FIRST
4. EU Green Light for GM? - Commissioner Byrne Statement
5. More Byrne
6. Question and Answers on the regulation of GMOs in the EU
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1. NEW EU REGULATION OPENS LOOPHOLES FOR UNAUTHORISED GMOS
GREENPEACE PRESS RELEASE
25 July 2001
Brussels - The long awaited regulations on traceabilty and labelling of genetically modified food and feed, presented by the European Commission today, risk opening a hole in a dike, allowing for the first time unauthorised genetically modified organisms (GMOs) into the European Union market, warned Greenpeace.
Greenpeace welcomes the introduction of a more thorough labelling regime, which includes products derived from GMOs such as oil and starch in food, as well as animal feed, which is the bulk of present GMO imports into the European Union. However the new regulations include a dangerous loophole: the Commission is proposing to set a one percent tolerance threshold not only for authorised but also for unauthorised GMOs. Below that threshold, their presence in a product would not need to be approved or labelled. If the European Parliament and Council endorsed this provision, EU member states would in fact give up their sovereignty over the regulation of GMOs to some extent.
At this moment the Commission proposes to apply these exemptions only to those GMOs, which have already received a favourable risk assessment by the EU scientific committees, but not the final market approval from the member states competent authorities and ministers. As they had deemed the present EU regulations inadequate, member states have imposed a de facto moratorium on GMO approvals for more than two years. Authorities have not agree on any of the approvals proposed by the Commission.
Scientists as well as politicians and NGOs have frequently questioned the EU Scientific Committees' favourable opinions on GMOs over the past few years. And the recent Scientific Committee conclusion that 'zero tolerance' of seed contamination from unauthorised GMOs is unworkable in practice was based on political and commercial assumptions, rather than scientific criteria. (1)
"The Commission's proposal is the wrong reaction to increased pressure and threats from the US administration and GMO producing companies like Monsanto, Aventis, Syngenta and DuPont," said Greenpeace European Unit political advisor Dr.Brigid Gavin. "If the EU sets clear and uncompromising safety standards the market will adapt to them. Opening loopholes like this however invites them to continue with their present strategy of sneaking unwanted and dangerous GMOs into our food chain."
"Member states should closely watch the Commission's intentions and make sure they keep full control of the proposed new European Food Agency. Once you give up the principle to only accept GMOs, which are authorised within and by the Community, a vicious circle of increasing contamination with such unauthorised GMOs will be started by interested companies," said Gavin.
FOR FURTHER INFORMATION PLEASE CONTACT:
Lorenzo Consoli, Greenpeace European Unit, press officer: + 32 496122112 Dr. Brigid Gavin, Greenpeace European Unit political advisor +32 2 2801400
Note:
1) Scientific Committee on Plants - Opinion concerning the adventitious presence of GM seeds in conventional seeds. Adopted on 7 March 2001.
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2. Pharma/Biotech
AFXpress
Last update 21:30:48 GMT
European consumer group seeks safeguards on accidental GM food contamination
BRUSSELS (AFX) - The European Consumers Organisation (BEUC) said it wants stricter EU safeguards to prevent accidental contamination of food and animal feed containing genetically-modified organisms.
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3. EU PROPOSALS ON GMOs PUT INDUSTRY FIRST, THE ENVIRONMENT AND CONSUMERS SECOND
When "unapproved" becomes "admissible"
Friends of the Earth Europe PRESS RELEASE 25th July 2001
Proposals adopted today concerning Traceability & Labelling of GMOs and Novel Food & Feed have been criticised by environmental group Friends of the Earth (FoE) which described them as a concession for the biotech industry to the detriment of European citizens.
After long and protracted debate, the EU Commissioners have finally adopted two proposals for new Regulations dealing with GMOs: one concerning traceability and labelling of GMOs and food/feed products produced therefrom, and the other on genetically modified food and animal feed. Both proposals contain major compromises that favour GMO producers. These are that GMOs not authorised in the European Union will be tolerated up to a certain threshold (1%) as long as their presence is deemed ‘adventitious’ or ‘technically unavoidable’, and that these unauthorised GMOs, as well as food/feed derived from them, will not have to be labelled (1). In addition, the Commission also proposes to amend the recently revised deliberate release Directive 2001/18/EC (just adopted by the European Parliament in February of this year) in order to accommodate these concessions (2).
According to FoE, the decision to allow GMOs not authorised by the EU onto the market is giving biotech companies a ‘licence to pollute’. "All companies have to do now is to say that the GMO contamination they created was ‘accidental’, and they get away with it", said Gill Lacroix, Biotechnology Coordinator at FoE Europe in Brussels. "It’s the thin-end-of-the-wedge syndrome they will contaminate our agriculture and food supply and that contamination will self-perpetuate as time goes on. They have managed to convince the Commission to legislate on how to accommodate GMO pollution, rather than to act on how to prevent it".
Lacroix said that, under the new proposals, European citizens would still not feel reassured about EU GMO legislation. Although FoE welcomes some positive developments in the proposals, it considers the move to allow contamination by unapproved GMOs unacceptable. "The decision to tolerate the presence of unauthorised GMOs in the EU is just capitulating to US government pressure and the interests of biotech companies", Lacroix said. "In the future, ‘unapproved’ will become ‘admissable’ how can people have confidence in a system like that?"
Friends of the Earth is the largest grassroots environmental network in the world. Friends of the Earth Europe's membership consists of 31 member organisations in 30 European countries with over 3000 local groups.
(1) The unauthorised GMOs referred to are those which have not yet received EU approval for release into the environment but for which companies have made applications to put them on the market. At the moment, 14 GM varieties are on this list, including 5 maize, 3 oilseed rape, 2 cotton, and 1 application each for GM varieties of tomato, potato, fodder beet, and chicory.
(2) Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and repealing Directive 90/220/EEC, was adopted by the European Parliament and the Council in February this year. Today’s proposals intend to already revise the new Directive by adding a paragraph to Article 2 to allow placing on the market of unauthorised GMOs up to a level of 1%.
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4. European Union Green Light to GM Foods?
Your Right To Know About Genetically Modified Food
- by EU Commissioner for Health Mr. David Byrne
- Irish Independent
http://www.unison.ie/irish_independent/stories.php3?ca=36&si=480629&issue_id=4940
"I can choose whether or not to buy food produced from a Genetically Modified Organism (GMO)." That is the choice I want to give consumers throughout Europe. When you don't know what you are buying, of course you may be concerned. Fear of the unknown is a most natural human reaction. I understand that perfectly.
That is the message you, the consumers of Ireland, have given me. That is the message your Government has given me. Your consumer representatives have also clearly spelled out your concerns to me. I am now going to deliver on your concerns. Your voice has counted. Today two European Commissioners are bringing your concerns directly into the meeting in Brussels where the Commission makes its weekly decision.
President Romano Prodi will chair this meeting. Both Margot Wallstrom, the Environment Commissioner and myself, responsible for Health and Consumer Protection issues, will address the President and our seventeen other colleagues. We will present to them, on your behalf, two new laws regulating GMOs in Europe. I believe our colleagues will give the green light to our ideas.
You are concerned about possible risks connected to GMOs. As European Commissioners, we too are taking precautions in our new laws to make sure that GMOs do not present any risk to your health or to the environment.
That is why we will have the European Food Authority examine in detail all applications for the use of GMOs in food or in feed for animals. The top scientists in Europe, independent of politics and industry, will vet the GMOs to make sure they are no risk to your health, the health of animals or to the environment. If the Food Authority's scientists say "No", then the GMO food or feed cannot be sold in Europe. Nor, indeed, can imported food or feed containing such a GMO be sold.
On the other hand, if the Food Authority says that the GMO is safe, then it is up to the Commission and representatives of each of the fifteen Governments in the EU to decide on allowing its use and under what particular conditions.
One basic condition is that the GMO food (or feed) must be labelled. This is to give you a choice: either to buy the product in question or to choose something else. At present, the EU's labelling regime gives you lots of information, about the food ingredients, additives and flavourings. We will soon add clear information about allergens. And this GMO legislation will add information about any GMO in food.
My aim is provide assurance for consumers that any product placed on the market is safe. After that it is for you to decide if you want to buy it or not. Labelling allows you to make that choice.
One other issue that arouses controversy concerns what is known as "adventitious presence". This means the unavoidable or accidental trace presence of a GMO in our food or feed. Whether we like it or not this is a reality. This is nature at work. Short of stopping the growth of GMO crops all around the world, or closing our borders, there is very little that can be done about it.
Our proposals for GMO legislation recognise this reality. And we are regulating it. We say that only minute traces of GMOs that are not formally authorised in Europe will be permitted in food or feed. But they first must have been assessed by our scientists as presenting no risk to human or animal health or to the environment which is a necessary step in the process before formal authorisation.
I said earlier that people are concerned about the unknown. But when in the future you see a label on a food product saying "genetically modified organism", you will have a number of real assurances. Firstly, that it has been assessed by the top scientists in Europe in the Food Authority.
Unless the scientists say "yes" it cannot go on the market. You will also be assured that the GMO has been examined by the Commission and representatives of your Government. And then it is up to you to choose.
* David Byrne is European Commissioner for Health and Consumer Protection.
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5. Biotechnology - 'The right to know about genetically modified food'
by David Byrne, Commissioner for Health and Consumer Protection,
25 July 2001
[ES] http://europa.eu.int/comm/food/fs/biotech/biotech07_es.pdf
[DA] http://europa.eu.int/comm/food/fs/biotech/biotech07_da.pdf
[DE] http://europa.eu.int/comm/food/fs/biotech/biotech07_de.pdf
[EL] http://europa.eu.int/comm/food/fs/biotech/biotech07_el.pdf
[EN] http://europa.eu.int/comm/food/fs/biotech/biotech07_en.pdf
[FR] http://europa.eu.int/comm/food/fs/biotech/biotech07_fr.pdf
[IT] http://europa.eu.int/comm/food/fs/biotech/biotech07_it.pdf
[NL] http://europa.eu.int/comm/food/fs/biotech/biotech07_nl.pdf
[PT] http://europa.eu.int/comm/food/fs/biotech/biotech07_pt.pdf
[FI] http://europa.eu.int/comm/food/fs/biotech/biotech07_fi.pdf
[SV] http://europa.eu.int/comm/food/fs/biotech/biotech07_sv.pdf
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6. Question and Answers on the regulation of GMOs in the EU
24 July 2001
http://europa.eu.int/comm/dgs/health_consumer/library/press/press171_en.pdf
European Union MEMO/00/277; Brussels, 24 July 2001
1. What are GMOs and GMMs?
Genetically modified organisms (GMOs) and genetically modified micro-organisms (GMMs) can be defined as organisms (and micro-organisms) in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating or natural recombination. The technology is often called "modern biotechnology" or "gene technology", sometimes also "recombinant DNA technology" or "genetic engineering". It allows selected individual genes to be transferred from one organism into another, also between non-related species.
2. What is the current legislation in the EU on GMOs?
Community legislation on GMOs has been in place since the early 1990s and throughout the decade, this regulatory framework has been further extended and refined. The EU introduced specific legislation designed to protect its citizens' health and the environment while simultaneously creating a unified market for biotechnology. The main legislation which authorises experimental releases and placing on the market of genetically modified organisms (GMOs) in the Community is currently Directive 90/220/EEC. A new, updated Directive 2001/18/EC on the deliberate release of genetically modified organisms was adopted by the European Parliament and the Council of Ministers in February 2001 and will enter into force on 17 October 2002. Directive 90/220/EEC put in place a step-by-step approval process on a case by case assessment of the risks to human health, animal health and the environment before any GMO or product consisting or containing GMOs can be released into the environment or placed on the market. Products derived from GMOs, such as paste or ketchup from a GMO tomato are not covered by this horizontal Directive but by vertical, sectoral legislation, for example the Regulation on Novel Foods and Novel Food Ingredients of 27 January 1997(Regulation (EC) 258/97). Directive 90/219/EEC as amended by Council Directive 98/81/EC on the contained use of GMMs which regulates the contained use of GMMs for research and industrial purposes.
3. What is the current procedure for approval of the release of GMOs into the environment?
Under Directive 90/220/EEC (or Directive 2001/18/EC from October 2002 ), a company intending to market a GMO must first submit an application to the competent national authority of the Member State where the product is to be first placed on the market. For experimental releases it is the competent authority of the Member State where the product shall first be released for research or development purposes.
The application must include a full risk assessment. If the national authority gives a favourable opinion on the placing on the market of the GMO concerned, this Member State informs the other Member States via the Commission. If there are no objections, the competent authority that carried out the original evaluation grants the consent for the placing on the market of the product. The product may then be placed on the market throughout the European Union in conformity with any conditions required in that consent.
If any objections are raised, a decision has to be taken at Community level. The Commission first asks for the opinion of its Scientific Committees. If the scientific opinion is favourable, the Commission then proposes a draft Decision to the Regulatory Committee composed of representatives of Member States for opinion. If the Regulatory Committee gives a favourable opinion, the Commission adopts the Decision. If not, the draft Decision is submitted to the Council of Ministers for unanimous adoption or rejection. If the Council does not act within 3 months, the Commission can adopt the decision.
4. What is the current risk assessment procedure?
There is no scientific evidence that the use of the technology is itself inherently unsafe. The safety of GMOs depends on the characteristics of the inserted gene(s), the final organism that is produced and its application The objective of the risk assessment is to identify and evaluate potential adverse effects of the GMO(s), either direct or indirect, immediate or delayed, taking also into account the cumulative and long term effects on human health and the environment which the deliberate release or the placing on the market of GMOs may have. The risk assessment also looks specifically how the GM product was developed and examines the risks associated with the gene products in the product (for example toxic or allergenic proteins), and the possibility of a gene-transfer (for example of antibiotic resistance genes).
The methodology of the risk assessment is as follows.
* Identification of any characteristics of the GMO(s) which may cause adverse effects
* Evaluation of the potential consequences of each adverse effect
* Evaluation of the likelihood of the occurrence of each identified potential adverse effect
* Estimation of the risk posed by each identified characteristic of the GMO(s)
* Application of management strategies for risks from the deliberate release or placing on the market of GMO(s)
* Determination of the overall risk of the GMO(s)
The Scientific Committee on Plants (SCP) has issued opinions on 17 GM plants under Directive 90/220/EEC. In one case an unfavourable opinion was given due to an insufficient risk assessment of the presence of a number of uncharacterised genes and particularly the gene which confers resistance to amikacin, a clinically important antibiotic. Therefore, this product was not allowed onto the market. The Scientific Committee on Food is responsible for opinions relating to Novel Foods. This Committee has issued one favourable opinion on food of plant origin (processed tomato) and 4 on products of microbial origin.
5. What will change when Directive 2001/18 comes into force?
The revised Directive updates and strengthens the existing rules of the risk assessment and the decision-making process on the release of GMO's into the environment. In particular it introduces mandatory information to the public and general rules on mandatory labelling and traceability at all stages of the placing on the market. The new Directive also foresees mandatory monitoring requirements of long-term effects associated with the interaction with other GMOs and the environment. Such effects will also to be taken into account in the risk assessment carried out prior to authorisation. First approvals for the release of GMO's will be limited to a maximum of ten years, and consultation of the Scientific Committee(s) becomes obligatory. The new Directive also introduces an obligation to consult the European Parliament on decisions to authorise the release of GMO's and the possibility for Council of Ministers to adopt or reject a Commission proposal for authorisation of a GMO by qualified majority.
6. How many GMO's have been approved for release into the environment? Since Directive 90/220/EEC entered into force in October 1991, the commercial release of 18 GMO's has been authorised in the EU by a Commission Decision, mostly following a qualified majority vote in the Regulatory Committee. In two cases the Commission Decision has not yet been implemented by the Member State (see Annex 1). Since October 1998 no further authorisations have been granted and there are currently 14 applications pending (see Annex 2).
Some Member States have invoked Article 16, the so-called safeguard clause, of Directive 90/220/EEC to temporarily ban the placing on the market of genetically modified maize and oilseed rape products in their territories. There are currently eight ongoing Article 16 cases involving Austria, Luxembourg, France, Greece and Germany. These cases have been examined by the Scientific Committee on Plants, which in all cases deemed that the information submitted by Member States did not justify their bans.
7. What are the rules on the marketing of GM foods?
Regulation (EC) 258/97 on Novel Foods and Novel Food Ingredients sets out rules for authorisation and labelling of novel foods including food products containing, consisting or produced from GMOs. The first step of an authorisation procedure is an assessment of an application to market a GM food product by the Member State where the food is to be first placed on the market. In case of a favourable opinion, this Member State informs the other Member States via the Commission. If there are no objections against the application, this Member State can authorise the product for marketing in the entire EU. If there are objections by other Member States, a decision at Community level is required. The Commission consults the Scientific Committees on matters relating to public health and adopts a decision after receiving a favourable opinion from the Regulatory Committee. Once a Decision at Community level is required, the time frame for authorisation is necessarily extended. As a derogation from the full authorisation procedure, the Novel Foods Regulation provides for a simplified procedure for foods derived from GMOs but no longer containing GMOs which are "substantially equivalent" to existing foods with respect to composition, nutritional value, metabolism, intended use and the level of undesirable substances. In such cases, the companies only have to notify the Commission when placing a product on the market together with either scientific justification that the product is substantially equivalent or an opinion to the same effect, delivered by the competent authorities of a Member State.
8. How many GMO's have been approved for use in food products?
Two genetically modified plants, a variety of soya and a variety of maize have been authorised under Directive 90/220/EEC prior to the entry into force of the Novel Foods Regulation, to be on the European market for the use in food. Under the Novel Foods Regulation no products consisting of or containing live GMOs have so far been authorised. Eleven applications concerning such products are pending at different stages in the procedure. Several products produced from GMOs have been notified to the Commission as being substantially equivalent (see Annex 3). The list of notifications is published in the Official Journal of the EU once a year.
9. What are the rules on Genetically modified feed?
No specific Community legislation on GM feed is in place yet. However, eight GMOs are authorised in accordance with Directive 90/220/EEC for the purpose of use in feed; these are four maize varieties, three rape varieties and one soya variety.
10. What are the rules on genetically modified seeds?
Community legislation on seeds, notably Directive- 98/95/EC, specifies that national authorities that have agreed to the use of a seed on their territory must notify this acceptance to the Commission. The Commission examines the information supplied by the Member State concerned and its compliance with the provisions of Community seeds legislation. If such is the case, the Commission includes the variety concerned in the "Common Catalogue of varieties of Agricultural Plant Species" which means the seed can be marketed throughout the EU. The seed legislation furthermore requires that GMO seed varieties have to be authorised in accordance with Directive 90/220/EEC before they are included in the Common Catalogue and marketed in the EU. If the seed is intended for use in food, it also has to be authorised in accordance with the Novel Foods Regulation.
Legislation on the marketing of forestry reproductive material also requires prior authorisation of GM material in line with the requirements of Directive 90/220. The Commission has proposed to amend the Community rules governing the marketing of vine material in line with Directive 90/220/EEC. In the White Paper on Food Safety the Commission has announced a proposal for a Regulation specifying the conditions for the environmental risk assessment for GM plant varieties. Further rules on growing conditions and other requirements for purity concerning the presence of GM seeds in seed lots of traditional varieties, as well as detailed labelling rules are also to be proposed.
11. How many GM seeds have been authorised?
So far only two GMO seed varieties have been included in the Common Catalogue for seed varieties which can be marketed in the EU, after prior authorisation under Directive 90/220/EEC. Applications for the inclusion of three new GMO seed varieties, already approved under 90/220/EEC, are pending.
12. What are the rules for Medicines, Protection of workers & Transport?
Authorisation of medicinal products for human and veterinary use (including such derived from genetically modified organisms) is regulated under Regulation (EEC) 2309/93 laying down Community procedures for the Council Directive 90/679/EEC on the protection of workers from the risks related to exposure to biological agents at work also regulates GMOs alongside other biological agents. Several pieces of legislation regulate transport of GMOs, in particular the Council Directives on the approximation of laws of Member States with regard to transport of dangerous goods carried by road, rail and inland seaways, the Council Directives on the appointment and vocational qualification of safety advisers for the transport of dangerous goods in the same sectors, as well as a Council Directive on uniform procedures for checks on the transport of dangerous goods by road.
13. What are the current rules on labelling?
The EU recognises the consumers? right for information and labelling as a tool to make an informed choice. Since 1997 labelling to indicate the presence of GMOs as such or in a product is mandatory. The Novel Foods Regulation provides for the mandatory labelling of foods and food ingredients which contain or consist of a GMO without prejudice to the other labelling requirements of Community law. The labelling requirements for foods derived from GMO, but no longer containing GMO are more complicated and based on the concept of equivalence 1 . Council Regulation 1139/98 lays down provisions for the labelling of foods and food ingredients derived from one maize and one soya 2 variety based on the presence of DNA or protein resulting from genetic modification. This criterion serves as a model providing the rules applicable to labelling of all foods and food ingredients derived from GMO. In January 2000, the Commission adopted Regulation (EC) 50/2000 ensuring that also additives and flavourings have to be labelled if DNA or protein of GMO origin is present in the final product. Regulation (EC) 49/2000 addresses the problem of adventitious contamination of GM material in conventional food. It introduces a 1% de minimis threshold for DNA or protein resulting from genetic modification below which labelling is not required, if operators can demonstrate that they have used appropriate steps to avoid the presence of GM material.
Genetically modified seed varieties must be labelled, in accordance with Council Directive 98/95/EEC. The label has to show clearly that it is a GM variety. Currently, there is no specific Community legislation on the labelling of GMO feed. The general labelling rules under Directive 90/220/EEC apply. A new Novel Feed legislation will foresee provisions for labelling.
Beate GMINDER: 02/296.56.94; Thorsten MUENCH: 02/296.10.63; Catherine BUNYAN: 02/299.65.12
1 This means that if a characteristic or property (composition, nutritional value or nutritional effects, intended use) renders a food or food ingredient no longer equivalent to an existing counterpart, it has to be labelled indicating the method (i.e. genetic modification) by which the characteristic or property was obtained. 2 These varieties were approved before the entering into force of the Novel Foods Regulation under Directive 90/220/EEC on the deliberate release into the environment of genetically modified organisms authorisation and supervision of medicinal products for human and veterinary use.