Cloned Animals & Food: EU Ban

The EU is getting ready to specifically ban both cloning of animals in the EU and the placing on the market of food from cloned animals. The European Commission is also proposing an overhaul of how other types of novel foods are authorised, with the length of time the procedure takes reduced from three years - as it is presently - to 18 months.

These are the key objectives contained in a “package” of three legislative proposals which, the Commission says, aim to address consumer safety and animal welfare concerns while still encouraging food sector innovation.

Context

Cloning is not currently used for food production in the EU, and no food business operator has applied for European authorisation to market food derived from cloned animals. Recent consultations have shown that citizens hold a broadly negative perception of the use of cloning for farming purposes.

A recent report on cloning, which is cited in one of the proposals, also expressed doubts that animal cloning can be justified "considering the current level of suffering and health problems of surrogate dams and animal clones".

The issues surrounding novel food - food which was not consumed in the EU to a significant degree before 1997 - are slightly different. While the authorisation and use of novel foods and food ingredients have been regulated in the EU since 1997, the procedure is lengthy and cumbersome.

The Commission wants to simplify and streamline the approvals process, in order to boost competitiveness while maintaining high food safety standards. The term ‘novel food’ refers in particular to food produced using new techniques and technologies such as nanomaterials.

Proposal Directive on Food from Animal Clones

The first proposal in the package is for a Council Directive on the placing on the market of food from animal clones.

Under the current legislative framework, food from clones falls under the scope of the existing Novel Food Regulation. However, the Commission has been asked by both the Council and the Parliament to prepare a separate legislative proposal on cloning.

The proposed Directive makes clear that it will be up to Member States to ensure that food from animal clones is not placed on the market. They will also be obliged to ensure that no food from animal clones is exported to the EU from third countries where cloning is permitted.

Member States will also have to take all measures necessary to ensure that the Directive is fully implemented, and lay down clear penalties for possible infringements. They will also provide the Commission with a report on their experiences of applying the Directive, five years after transposing it into national law.

The Commission will also present a report to the European Parliament and the Council on the application of the Directive, taking into account the reports submitted by Member States.

Proposed Directive on Cloning of Animals

The second draft Directive in this policy package is a proposal for a Parliament and Council Directive on the cloning of animals. The proposal covers cow, pig, sheep, goat and horse species kept and reproduced for farming purposes.

The aim is to ensure uniform conditions of production for farmers across the EU, while protecting the health and welfare of animals. It states very clearly that Member States will prohibit the cloning of animals and the placing on the market of animal clones and embryo clones.

As with the first proposal for a Directive, Member States must ensure that the legislation is fully implemented, lay down clear penalties and provide the Commission with a report. The Commission will also present a report to the European Parliament and the Council on the application of this particular Directive.

Proposed Regulation on Novel Foods

Finally, the third proposal in the package is for a Regulation on novel foods. This proposal is limited solely to the safety of novel food – the other two proposals deal with cloning issues – and is based on an overall agreement already reached between the European Parliament and the Council.

The aim is to ensure food safety, protect public health and supporting food sector innovation by streamlining the authorisation procedure. All novel foods and their use in food will have to comply with the following straight forward criteria: they should not present a danger to human health and their use should not mislead the consumer.

The definition of a novel food is also clarified to include new technologies which have an impact on food. Nanomaterials for example, which are intended for food use will be assessed and authorised under this Regulation before being placed on the EU market.

Determining Novel Food Status

Food business operators must verify whether or not the food which they intend to place on the EU market falls within the scope of this Regulation, and can consult a Member State if they are unsure. In this case, food business operators must provide necessary information on request.

Authorisation Procedure

Novel foods will be subject to a much faster harmonised safety evaluation and authorisation procedure. The current system of individual authorisations will be replaced by generic authorisations. The Regulation will also introduce a more proportionate safety assessment for foods from third countries, which have a history of safe food use.

Already authorised novel foods will continue to be marketed and will be included in the EU list of novel foods.

Applicants must include:
• the name and description of the novel food
• the composition of the novel food
• scientific evidence demonstrating that the novel food does not pose a safety
risk to human health
• where applicable, a proposal for the conditions of use and a proposal for specific labelling requirements which do not mislead the consumer

Role of the Commission

In line with the decision to switch to a centralised EU-level procedure and to separate risk management and risk assessment, all applications for the authorisation of novel foods will be submitted to the Commission. The Commission may then request a scientific opinion on risk assessment from the European Food Safety Authority (EFSA).

Where the Commission requests an opinion from EFSA, it shall forward the valid application to the authority, which will adopt its opinion within nine months from the date of receipt of a valid application. The inclusion of a novel food in the EU list of novel foods will be considered by the Commission on the basis of the opinion from EFSA.

Within nine months from the date of publication of EFSA's opinion, the Commission

will submit to the Standing Committee on the Food Chain and Animal Health (SCOFCAH) a draft implementing act, updating the EU list.

Post-Market Monitoring

The Commission may, for food safety reasons and taking into account the opinion of EFSA, impose a requirement for post-market monitoring of a novel food to ensure that the use of the authorised novel food is within safe limits. Food business operators must inform the Commission of:
• any new scientific or technical information which might influence the evaluation of the safety in use of the novel food
• any prohibition or restriction imposed by any third country in which the novel food is placed on the market

Exemptions

This Regulation will not apply to genetically modified foods falling within the scope of Regulation (EC) No1829/2003; food enzymes falling within the scope of Regulation (EC) No 1332/2008; food additives falling within the scope of Regulation (EC) No
1333/2008; food flavourings falling within the scope of Regulation (EC) No
1334/2008; and extraction solvents used or intended to be used in the production of foodstuffs or food ingredients and falling within the scope of Directive
2009/32/EC.

Next Steps

The European Parliament and the Council will consider the Commission's draft legislative package in due course. The Commission estimates that the legislation will enter into force in 2016 at the earliest.