Currently, the EU Novel Foods Regulation from 1997 is the only EU legislation covering animal cloning. Under the Novel Foods Regulation, food “produced from non-traditional breeding techniques” (implicitly including cloning) – but not from their offspring – requires a pre-market authorization in order to be imported or sold in the EU. In January 2008, the European Commission proposed a revision of the EU’s Novel Foods Regulation to simplify the authorization procedure. Under the co-decision procedure, the Parliament and the Council proposed to add more measures for food derived from clones and offspring of clones. In March 2011, the European Parliament and Council of the European Union failed to bridge differences over the introduction of mandatory labeling requirements for all food produced from the offspring of clones. For more information on the failure of the Conciliation procedure see GAIN report “EU Novel Foods Proposal failed to win Approval”. As a result, the proposed Novel Foods revision could not become law and the current Novel Foods Regulation still applies (more information on the Novel Foods Webpage).
NEW LEGISLATIVE PROPOSALS ON ANIMAL CLONING PUBLISHED
On December 18, 2013, the Commission announced three legislative proposals: 1) a proposal on the cloning of animals of the bovine, porcine, ovine, caprine and equine species kept and reproduced for farming purpose; 2) a proposal on the placing on the market of food from animal clones; and 3) a new proposed regulation for novel foods.
The first proposal on animal cloning would ban animal cloning for farming purposes in the EU for bovine, porcine, ovine, caprine and equine species, as well as imports of cloned animals and embryos. The ban on cloning would be in place for five years, after which the scientific progress on the efficacy of the cloning technique would be reassessed. This proposal for a European Parliament and Council Directive has to be adopted under the ordinary legislative procedure (co-decision). Under this procedure, both the European Parliament (EP) and Council have to reach agreement on the Commission proposal. The legal basis for this proposal is Art. 43 of the Lisbon Treaty and refers to the Common Agricultural Policy which is normally covered by the Agriculture (AGRI) Committee in the EP. In the proposal, the Commission justifies a ban on cloning because of the cloning-related animal welfare concerns raised in the Update of the European Food Safety Authority’s (EFSA) scientific opinion.
The second proposal (banning the marketing of food, i.e. meat and dairy products from cloned animals in the EU) is a Council directive regulating the EU internal market. The proposal banning the marketing of products from clones is not based on animal welfare concerns, nor is there a food safety issue with the products from cloned animals. For this reason, the Commission based this proposal on Article 352 of the Lisbon Treaty, also known as the flexibility clause. The flexibility clause allows the EU to create rules in areas that are not covered specifically by the treaties. In this way, if the Commission wants to draft a legislation purely to inform consumers about a subject but no legal basis to do so exists in the treaties, the Commission can apply Article 352 as a legal basis for a proposal. The consent procedure is the legislative procedure for this article, which allows the EP the right to oppose the proposal, but not to amend it. However, without the EP’s consent, the Council cannot adopt it and the Council must also act unanimously on this proposal.
The proposed legal instrument for both proposals is a directive. Unlike a regulation, which is binding in its entirety and automatically enters into force on a set date throughout the EU, Member States have to transpose the rules set out in a directive into national legislation. The objective of the proposed rules is the same for all Member States (MS) but how and when the MS will implement the directives can vary. According to the explanatory memorandum that accompanies both proposals, a directive “allows Member States to employ existing control tools as appropriate for the implementation of Union rules and thus to limit the administrative burden”.
Neither of the proposed cloning directives cover offspring from cloned animals, nor products derived from their offspring. In a press release, Health Commissioner Borg explained that labeling for fresh meat from offspring of cloned animals could be required at a later date, pending a feasibility study report from DG AGRI on the consequences of labeling for both the EU domestic meat market and meat imports. Because of the expected length of time necessary for the legislative approval procedure, it is unlikely that this draft legislation will be enter into force before 2016 at the earliest.
For more information on the EU decision-making procedures, see GAIN report “How the European Union Works – A Guide to EU Decision-Making”. This report explains the different stages and key actors in the development of new framework legislation, from the Impact Assessment to the final phase of the ordinary legislative procedure.
NEXT STEPS FOR ANIMAL CLONING PROPOSALS
The EP AGRI (Agriculture) Committee and the ENVI (Environment, Public Health and Food Safety) Committee have been designated as joint lead committees for the animal cloning proposals. MEP Giulia Moi (Europe of Freedom and Direct Democracy Group – EFDD) and MEP Renate Sommer (European People’s Party – EPP) are the rapporteurs for the respective committees.
– Council of the European Union first reading position: currently under discussion.
– On January 15, 2016, the European Commission feasibility study on labeling of food from animal clones and offspring was published.
– On September 8, 2015, the European Parliament adopted its first reading position in plenary.
– On June 25, 2015, the joint ENVI and AGRI Committees adopted their report for amending the Commission proposals.
– On April 28, 2015 the amendments tabled in the joint committee were published.
– On March 23, 2015, the draft report of the joint AGRI and ENVI Committee of the EP was published.
– December 18, 2013: Commission proposals on animal cloning for food production were published.
- The first proposal would ban animal cloning for food purposes in the EU, as well as imports of cloned animals and embryos.
- The second proposal would ban the marketing of food, i.e. meat and dairy products from cloned animals in the EU.
– The Impact Assessment, on which these proposals are based, was published simultaneously.
– Public consultation closed on September 3, 2012
– “Roadmap” published in February 2012
ANIMAL CLONING RISK ASSESSMENTS
In January 2008, FDA released a final risk assessment in which it concludes that meat and milk from cow, pig, and goat clones and the offspring of any animal clones are as safe as food from conventionally bred animals. FDA’s risk assessment and other information on animal cloning can be downloaded from their website at www.fda.gov/cvm/cloning.htm.
In July 2008, the European Food Safety Authority (EFSA) published its final scientific opinion on the implications of animal cloning. EFSA states that there is no indication that differences exist in terms of food safety between food products from healthy cattle and pig clones and their progeny, compared with those from healthy conventionally-bred animals. In September 2010, EFSA published a further statement on animal cloning following the endorsement of its Scientific Committee. The Scientific Committee concurred that no new scientific information had become available that required EFSA to reconsider its previous conclusions and recommendations.
In December 2011, the Commission requested a further update from EFSA regarding the status of cloning of farmed animals for food production purposes. On July 5, 2012, EFSA published an update of its scientific statement reiterating its earlier findings: with respect to food safety, there are no indications that food products derived from healthy clones or their offspring are different from those of healthy conventionally bred animals. There are also no scientific indications that animal cloning presents a greater risk to genetic diversity, biodiversity, or the environment than conventionally bred animals.