Explanatory Memorandum to COM(2013)893 - Placing on the market of food from animal clones - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2013)893 - Placing on the market of food from animal clones. |
|---|---|
| source | COM(2013)893  |
| date | 18-12-2013 |
Cloning is a relatively new technique of asexual reproduction of animals producing near exact genetic copies of the animal cloned, i.e. without modification of genes.
In food production cloning is a new technique. Hence, under the current legislative framework, food from clones falls under the scope of the Novel Food Regulation[1] and is thus subject to pre-market approval based on a safety risk assessment.
In 2008 the Commission presented a proposal[2] to streamline the approval process in the Novel Food Regulation. In the legislative procedure lawmakers aimed to amend the proposal to introduce specific rules on cloning[3]. Yet no agreement was reached on the scope and features of these insertions so that the proposal was not adopted by the co-legislators after the Conciliation failed in March 2011. As a result the Commission was asked to prepare a legislative proposal on cloning in food production based on an impact assessment outside the Novel Food Regulation i.
The European Food Safety Authority (EFSA) concluded that there is no indication of any difference for food safety for meat and milk of clones and their progeny compared with those of conventionally bred animals. However EFSA has identified animal welfare hazard related to the low efficiency of the technique. It up-dated its opinion on cloning of animals last in 2012[5] concluding that scientific knowledge available on cloning has increased but that nevertheless its efficiency remains low compared to other reproduction techniques.
The objective of this proposal is to address consumer perceptions on the use of food from animal clones.
Animal cloning is a new technique in food production. Thus, currently, food derived from animal clones falls under the scope of the Novel Food Regulation. Under this Regulation food produced by new techniques can only be marketed after specific authorisation. Such pre-market approval must be based on a favourable assessment of the risk for food safety which is to be undertaken by EFSA. No application has ever been submitted for an authorisation to market food produced by means of the cloning technique.
This initiative responds to the above-mentioned concerns while avoiding unnecessary burdens for farmers, breeders or food business operators established in the Union and in third countries. The proposal envisages a suspension on Union territory of the marketing of food from clones.
The provisional prohibitions of the marketing of food from clones complements the suspensions of the use of the technique for farming purposes and the marketing of live clones proposed in a parallel measure. The provisional prohibition of the marketing of food from clones is also kept under review to take account of potential changes in consumer perceptions on cloning linked to animal welfare concerns and of international developments.
Contents
- RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENT
- LEGAL ELEMENTS OF THE PROPOSAL
- BUDGETARY IMPLICATION
- 1.1. Background of the proposal
- 1.2. Objectives of the proposal
- 1.3. Regulatory framework
- 1.4. Consistency with other policies and objectives of the Union
- 2.1. Consultation process
- 2.1.1. Consultation methods and main sectors targeted
- 2.1.2. Summary of responses and how they have been taken into account
- 2.1.3. External expertise
- 3.1. Legal basis
- 3.2. Subsidiarity principle
- 3.3. Proportionality principle
- 3.4. Choice of instruments
Member States, stakeholders and third countries trade partners were consulted.
The Standing Committee for the Food Chain and Animal Health was the main forum for discussions with Member States. In addition all Member States completed a specific questionnaire on cloning on their territory.
Stakeholders were consulted in the Advisory Group of the Food Chain. Twenty-two organisations representing all sectors concerned (farmers, breeders, food industry, retailers, consumers and animal rights activists) participated. In addition 5 technical meetings were held with organisations representing farmers, breeders and food industry.
A specific questionnaire was sent to the 15 major third country trade partners of which 13 replied.
The general public was consulted via the Interactive Policy Making Initiative in March 2012. This tool reaches approximately 6000 subscribers with 360 replied[6].
Two Eurobarometer surveys addressed cloning: a 2008 specific survey on cloning[7] performed in 27 Member States and a 2010 survey on biotechnology[8] with specific questions on cloning performed in 27 Member States and 5 non-Union European countries.
The specific report on cloning by the European Group on Ethics in Science and New Technologies (EGE) of 2008[9] expressed doubts that animal cloning for farming purposes can be justified 'considering the current level of suffering and health problems of surrogate dams and animal clones'. The EGE also concluded that it did 'not see convincing arguments to justify the production of food from clones and their offspring'.
Member States confirmed that animals are presently not cloned for food production in the Union. The economic sectors involved (farming, breeding, food industry) indicated that they have, at this time, no interest to produce food from animal clones.
Argentina, Australia, Brazil, Canada, and the United States confirmed that animals are cloned on their territory but could not indicate to what extent. In Brazil, Canada and the United States clones are registered by private companies. In Canada the legal situation on cloning is similar to that in the Union, i.e. food produced from animal clones is considered novel and requires pre-market approval. Argentina, Australia, Brazil, Canada, New Zealand, Paraguay and the United States pointed out that measures should be science-based. They moreover stressed that measures should be no more trade-restrictive than necessary to fulfil legitimate objectives.
Union citizens, on the other hand, hold a broadly negative perception of the use of the cloning technique for the production of animals for farming purposes. As a result consumers would not want to eat food derived from a clone.
This initiative takes account of the results of the consultations. It addresses justified concerns in a proportionate manner and considers the limits of the powers conferred to the Union by the Treaties.
In 2008 the European Food Safety Authority (EFSA) delivered an opinion on cloning. It focused on animal clones, their progeny and of the products obtained from those animals. This opinion was up-dated by three statements in 2009, 2010 and 2012[10]. Based on the available data EFSA saw animal welfare problems related to the health of surrogate mothers (carrying the clones) and the clones themselves. Surrogate dams suffer in particular from placenta dysfunctions contributing to increased levels of miscarriages. This contributes, amongst others, to the low efficiency of the technique (6-15 % for bovine and 6 % for porcine species) and the need to implant embryo clones into several dams to obtain one clone. In addition, clone abnormalities and unusually large offspring result in difficult births and neonatal death. A high mortality rate is a characteristic of the cloning technique.
On the other hand EFSA repeatedly stated that cloning has no impact on the safety of meat and milk obtained from the clones.
2.2. Impact assessment[11]
Based on the experience gained in the legislative procedure which failed in March 2011 and the positions expressed by stakeholders, four options were assessed. Option 4 included, among others, the temporary suspension of the placing on the market of food from clones.
As a result of the analysis of the four options, and considering their impacts and the objectives pursued, this element of Option 4 was retained as the basis of the present proposal. Its impact on Union food business operators (FBOs) and trade is limited because trade, if any, is likely to be insignificant as FBOs have no interest to market food from clones.
This option has a positive impact on citizens: their concerns about animal welfare will be addressed as no food from clones will be placed on the market in the Union.
The Treaty does not provide, for the adoption of this Directive, powers other than those under Article 352. This Directive addresses animal welfare concerns of consumers related to the use of a reproduction technique that has no impact on the safety or quality of the food produced but implies animal suffering. Article 169 TFEU calls the Union to promote the interest of consumers when adopting measures under Article 114 in the context of the completion of the internal market. Under Article 13 TFUE, in formulating and implementing the Union's internal market policy, the Union and the Member States must pay full regard to the welfare requirements of animals since animals are sentient beings. According to an established case-law[12], the choice of Article 114 TFUE as a legal basis is justified where there are differences between national rules which are such as to hinder the functioning of the internal market. Recourse to that provision is also possible if the aim is to prevent the emergence of such obstacles to trade resulting from the divergent development of national laws. However, the emergence of such obstacles must be likely and the measure in question must be designed to prevent them. In the present case, no current or likely divergence between national legislations was detected. Moreover, during the Conciliation referred to in paragraph 1.1. above, Member States expressed their willingness to see measures on cloning at EU level, but they did not specify which type of national measures they would put in place in the absence of EU initiative.
Isolated Member States measures on food from clones, if adopted, could lead to distortions of the markets concerned. Moreover, the measure concerns import controls. It is thus necessary to ensure that the same conditions apply and thus to address the matter at Union level.
Animal cloning in food production has no benefit for the consumer and the food industry has no interest to market food from clones. At its present state of development it also appears that its use in food production is of limited benefit. The suspension of the marketing of food from clones complements the suspensions of the use of the technique for farm purposes and the marketing of live clones (animal clones) proposed in a parallel measure and thus strikes a reasonable fair balance between animal welfare, citizens' concerns and the interests of farmers, breeders and other stakeholders involved.
The proposed instrument is a Directive. Other types of measures would not be appropriate for the following reasons:
(i) a directive allows Member States employ existing control tools as appropriate for the implementation of Union rules and thus to limit the administrative burden;
(ii) soft law instruments are considered insufficient to prevent the use of a technique throughout the Union.
In accordance with the Joint Political Declaration of Member States and the Commission on explanatory documents, Member States have undertaken to accompany, only in justified cases, the notification of their transposition measures with one or more explanatory documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. Considering the limited legal obligations set by this Directive, explanatory documents from the Member States in the context of transposition of this Directive are not needed.
This initiative has no budgetary implications for the EU and requires no additional human resources in the Commission.