Mr. Gregory Canning:

I thank the joint committee for giving the Department the opportunity to speak about the proposal to amend the current regulation and the basis for it. The Commission is proposing to allow member states in certain circumstances to restrict or prohibit the use of authorised genetically modified food or feed in their territories.

It is proposed that member states be allowed to make use of this "opt-out" provision, subject to their being able to justify the restriction or prohibition on a case by case basis.

Under the existing provisions laid down in Regulation EC 1829/2003, only authorised GM food or feed may be placed on the EU market and when present in a food or feed at greater than a figure of 0.9%, it must be labelled accordingly. The current regulation also sets out a centralised procedure for the safety assessment and authorisation of food and feed from a GM source. Even where a genetically modified organism, GMO, or a product derived from a GMO is to be used only in animal feed, its safety with respect to human food is also assessed and vice versa. The authorisation procedure put in place by the regulation ensures the products concerned will not pose a risk to human and animal health and the environment. The authorisation of a GM food or feed in the European Union begins with a safety assessment carried out by the European Food Safety Authority, EFSA, a risk assessment body established under the regulation. Each application is assessed on a case by case basis and once the dossier has been deemed complete by the EFSA, it forms the basis for an authorisation or rejection proposal which is then presented by the Commission to member states to be voted on at standing committee level.

As our colleague has outlined, since the entry into force of Regulation EC 1829/2003, a qualified majority of member states has never been achieved either for or against authorisation of a GM food or feed. The applications are, therefore, sent to the appeals committee to try to reach a majority decision. Where this is not achieved, an application is sent to the Commission for final decision. The Commission has stated the reasons given by many member states to justify abstaining in votes or rejecting applications are usually not based on science but on other considerations. Where there is scientific evidence demonstrating that an authorised GM product is likely to pose a risk to human or animal health or the environment, the regulation allows the Commission or member states to adopt emergency measures restricting or prohibiting the placing on the market of the product. This is the only basis allowed to member states to restrict the placing of GM food or feed on the market once a product has been authorised.

The Commission is proposing to amend Regulation EC 1829/2003 to provide that individual member states may, subject to certain conditions, adopt measures to restrict or prohibit the use of GM food and feed on part or all of their territories. There is a series of caveats set out in the recitals to the proposal, which are as follows: the member state must be able to justify the prohibition or restriction on the grounds of an overriding public interest in accordance with Article 36 of the treaty as developed by the case law of the European Court of Justice; the measures must not infringe Article 34 of the treaty on the free movement of goods; the measures must be reasoned and compatible with the principles of proportionality and non-discrimination between national and non-national products; as stated, the reasons for prohibition or restriction cannot be linked with health risks as they are already dealt with centrally by the EFSA and the emergency measures covered in Regulation EC 1829/2003; and the measures cannot be used to prohibit or restrict the placing on the market of products containing less than 0.9% GM material, which products are already dealt with under the existing regulation. Essentially, this means that products containing adventitious or technically unavoidable amounts of GM material are not required to be labelled as containing GM material.

Under the new provisions, the prohibition or restriction of a GM product by a member state may only occur after the GM product has been authorised. This process will thus not affect the procedure for authorisation of GM food and feed which will remain valid for the whole of the European Union. Once a GM product is authorised in the European Union, it may be marketed in all member states, including Ireland. GM food ingredients authorised in the European Union include soya bean, maize, oilseed rape, cotton, sugar beet and starch potato. Under the current regulation, if more that 0.9% of a food or ingredient is derived from a GM source, it must be labelled accordingly.

GM foods are not generally sold in Ireland, a situation similar to that in other EU member states. An evaluation of the EU legislative framework for food and feed published in June 2010 by DG Sanco suggests this is because food markets have evolved towards the dominant use of non-GM supply chains. Monitoring of the Irish marketplace has been co-ordinated by the Food Safety Authority of Ireland since 2001, which ensures only authorised GM foods or ingredients are on the market and that consumers are allowed to purchase or avoid these products by virtue of accurate labelling.

Sampling and analysis of GM foods are mainly concentrated on processed food containing soya, maize or rice as these are foods where GM ingredients are more commonly found. Inspection results are published on the FSAI website and demonstrate that only a small proportion of foods analysed contain GM ingredients but that these are generally authorised GM ingredients and are below the labelling threshold of 0.9%.

To date, Ireland has always adopted a science-based but precautionary approach to GM foods while consumer choice has been ensured by adequate monitoring of the marketplace. This new Commission proposal provides member states with a unilateral means of prohibiting or restricting the marketing of EU-authorised GM food and feed ingredients in their territories without having to resort to emergency measures provided for under article 34 of the regulation. The proposal does not define the reasons that can be invoked by member states other than to stipulate that they cannot be based on perceived risks to human or animal health or the environment. The Department of Health is of the view that the provisions of the legislation currently in place for authorising GM food and feed in the EU provide adequate science-based safeguards in the context of human and animal safety and the environment.

We are available for any questions members may have.