Clash Over Novel Foods Policy

The revision of a key EU Regulation on novel foods risks failing after almost two years of debate. The EU institutions are unable to agree on how to handle products from naturally-born descendants of cloned animals.

The European Parliament is calling for an outright ban on such products, while the Council and the Commission do not support that approach. If, as appears likely, Parliament and Council are unable to reach agreement by March 30, this legislative initiative will have failed and one of the most controversial areas of novel foods policy will remain unregulated.

The debate appears to pit the opinion of EU consumers, who are largely against products from cloned animals because of public health and animal welfare concerns, against the EU’s commercial interests in international trade as well as compliance with WTO agreements.


The current Regulation on novel foods dates from 1997 and lays down authorisation rules for foods and food ingredients that have not been used for human consumption to a significant degree within the EU before or are produced by a method that has not previously been used before May 1997.  The Regulation also applies to foods that have not been on the EU market to before its entry into force.

A revision of the Regulation was considered necessary in light of new food industry methods and technologies that have appeared, in and outside the EU, since its adoption.

Proposal for new Regulation

In 2008 the European Commission chose to propose an entirely new Regulation on novel foods and repeal the old one, rather than propose a revision of the old one. 

The proposal aims to create a centralised authorisation system to simplify and speed up the procedure of authorisation for novel foods. The Commission would receive the application for authorisation and the European Food Safety Authority would carry out the scientific assessment on the product. The Commission has chosen the “one door-one key” approach which means that the applicant may make one application for approval covering all possible uses of the substances in question. Only novel foods that are included on the Community list after assessment by the EFSA and a final decision made by the Commission may be placed on the market.

The proposal also sets out data protection rules, which aim to protect newly developed foodstuffs once authorised, and encourage companies to invest in developing new types of foods and food production techniques.

A notification procedure is introduced for foods which have not been traditionally sold in the EU but which have a safe history of use in third countries.

Besides repealing the old Novel Foods Regulation, the new measure it would also amend the Regulation on the authorisation procedure for food additives, food enzymes and food flavourings and repeal Regulation on food information requirements for novel foods.

Products from cloned animals and their descendants

The European Parliament and the Council reached an agreement to ban the use of cloning in animal reproduction aimed at food production. Therefore, in the begging of March 2011, the Commission adopted a report which includes a recommendation for legislation that would ban cloning animals for food production. The report highlights animal welfare issues such as the increased morbidity of cloned animals, increased incidence of large offspring leading to difficult births, as well as long term complex health problems for clones. The Report also considered the ethical implications of cloned animals, in light of health issues that commonly effect clones. Currently there are no Member States using cloned animals for food, however due to trade with countries using cloned food industry (mainly the USA), it is very difficult to trace how many cloned animals or products have entered the EU market.

However, the question on products from naturally born descendants of cloned animals remains controversial, being the main cause for disagreements between the institutions, unable to find a common position on the new Regulation at first and at second reading.

The Parliament considers that foods derived from cloned animals should be excluded from the scope of the Regulation on novel foods and be addressed in a separate and more specific legislation on cloning. The Parliament insists that EU consumers are against such products for health, ethical and animal welfare concerns.

On the other hand, the Council and the Commission refuse to ban the sale of naturally born offspring of cloned animals. The Council considers that emerging technologies in breeding and food production processes which have an impact on food, and thus might have an impact on food safety, should be covered by the Regulation. Novel food should therefore include foods derived from cloned animals’ offspring.

The main argument is the impossibility to trace such products in the food chain and therefore, the EU will have to reject imports of all meat and dairy products from countries using cloned food industry.  This would harm consumers by increasing prices and rural communities who depend on farming due to possible retaliation by our trading. Such a ban would aggravate EU’s international commercial relations and would cause problems as regards WTO engagements.

The failure of revision of the old novel foods regulation would put on hold food industry innovation and, until a new proposal comes out, there will be a legal vacuum, as no measure will regulate the food cloning industry and other new technologies, like foods produced using nanotechnology.

Conciliation procedure

As the Council rejected the amendments adopted by the Parliament at second reading on 7 December 2010, the third reading will give the institutions a final attempt to adopt the proposal by negotiating a compromise during the conciliation procedure.

The Conciliation Committee is composed of members of the Council or their representatives and an equal number of representatives of the Parliament, as well as the Commissioner responsible.

The work of the Conciliation Committee is prepared in the course of trialogues involving negotiators for each institution attempting to draw up a compromise (“joint text”). The institutions have six weeks to discuss the details of a compromise in the informal trialogue meetings. The length of the trialogue meetings can be extended by a further two weeks. Following the conclusion of the trialogue meetings, the conciliation committee will then have six weeks to adopt a joint text. The committee can extend their work by a further two weeks.

The Council’s delegation must approve the joint text by a qualified majority (unanimity in cases specified by the Treaty) while the Parliament’s delegation by a simple majority. The Commission plays a mediating role and aims to reconcile the positions of the two co-legislators.

In some cases, like the present one, several meetings of the Conciliation Committee will be necessary to ensure that the members of the delegations are fully aware of all positions and able to make a decision.

Next steps

The Concision Committee did not manage to reach an agreement during its meeting on 16 March 2011. The next meeting of the Committee is scheduled for 28 March 2011 and it will have the final chance to reach an agreement on the text until 30 March 2011.

If a text is agreed it is scheduled to be voted in the European Parliament on 10 May 2011 and then it will go to the Council. Should either of the institutions fail to give approval, the act will not be adopted and the procedure is ended.