EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, 18.12.2013  
COM(2013) 892 final 
2013/0433 (COD) 
  
Proposal for a 
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on the clonin g of animals of the bovine, porcine, ovine, caprine and equine species kept 
and reproduced for farming purposes 
{SWD(2013) 519 final} 
{SWD(2013) 520 final}  EN 2   EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL 
1.1. Background of the proposal 
Cloning is a relatively new technique of asexual reprodu ction of animals producing 
near exact genetic copies of the animal cloned, i.e. without modification of genes. 
In food production cloning is a new techni que. Hence, under the current legislative 
framework, food from clones falls under the scope of the Novel Food Regulation1 
and is thus subject to pre- market approval based on a food safety risk assessment. 
In 2008 the Commission presented a proposal2 to streamline the approval process in 
the Novel Food Regulation. In the legisla tive procedure lawmakers aimed to amend 
the proposal to introduce specific rules on cloning3. Yet no agreement was reached 
on the scope and features of these insertions so that th e proposal was abandoned after 
a failed Conciliation in March 2011. As  a result the Commission was asked to 
prepare a legislative propos al on cloning in food producti on based on an impact 
assessment outside the Novel Food Regulation4. 
The European Food Safety Authority (EFSA) views cloning primarily as an animal 
welfare hazard related to the low efficiency of the technique. It up-dated its opinion 
on cloning of animals in 20125 concluding that scientific knowledge available on 
cloning has increased but that nevertheless its efficiency remains low compared to 
other reproduction techniques. 
1.2. Objectives of the proposal 
The objective of this proposal is to e nsure uniform conditions of production for 
farmers while protecting the hea lth and welfare of animals. 
1.3. Regulatory framework 
Directive 98/58/EC6 on the protection of animals kept  for farming purposes sets very 
general minimum animal welfare standards for animals used in agriculture. It does 
not refer explicitly to cloning, but calls on Me mber States to avoid unnecessary pain, 
suffering or injury in farm animals. If cloning causes unnecessary pain, suffering or 
injury Member States have to ac t at national level to avoid it. 
                                                 
1 Regulation (EC) N° 258/97 of the European Parliament and the Council of 27 January 1997 concerning 
novel foods and novel food ingredients. 
2 Proposal for a Regulation of the European Parliament and of the Council on novel foods COM(2007) 
872 final of 14.1.2008.  
3 Report from the Commission to the European Parliament and the Council on animal cloning for food 
production COM (2010) 585 of 19.10.2010 suggested to (i) to suspend temporarily the use of the cloning technique, clones and of food from clones fo r five years; (ii) to trace imported reproductive 
materials of clones. http://ec.europa.eu/dgs/health_consumer/docs/20101019_report_ec_cloning_en.pdf
 
4 For example, the European Parliament resolution of 6 July 2011 on the Commission Work Programme 
2012 requested a legislative proposal to prohibit food from clones, offspring and descendants: 
http://www.europarl.europa.eu/sides/getDoc .do?pubRef=-//EP// TEXT+TA+P7-TA-2011-
0327+0+DOC+XML+V0//EN (Procedure 2011/2627(RSP), point 31) 
5 EFSA Statement of 2012 overall conclusion p.18. EFSA statements 2012 and 2010:  
http://www.efsa.europa.eu/en/efsajournal/pub/2794.htm and  http://www.efsa.europa.eu/en/efsajournal/pub/1784.htm 
6 Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming 
purposes OJ L 221, 8.8.1998, p. 23. EN 3   EN 1.4. Consistency with other policie s and objectives of the Union 
This initiative responds to the above-mentioned concerns while avoiding unnecessary 
burdens for farmers and breeders establishe d in the Union and in third countries.  
The proposal envisages a susp ension on Union territory of: 
• the use of the technique for food production purposes;  
• the marketing of live clones (animal clones). These provisional prohibitions  will confine a production technique causing distress 
to animals to areas where it appears to have particular benefit. 
The provisional prohibitions are kept under review given the development of 
knowledge on the technique and progress in th e application of the technique in areas 
outside farming. 
This initiative excludes cloning carried out in research, for the preservation of rare 
breeds or endangered species and for th e production of medicinal products and 
medical devices. 
2. RESULTS
 OF CONSULTATIONS  WITH  THE  INTERESTED  PARTIES  AND  
IMPACT  ASSESSMENT 
2.1. Consultation process 2.1.1. Consultation methods a nd main sectors targeted 
Member States, stakeholders and third c ountry 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 cl oning on their territory. 
Stakeholders were consulted in the Advi sory Group of the Food Chain. Twenty-two 
organisations representing all sectors conc erned (farmers, breeders, food industry, 
retailers, consumers and animal rights act ivists) participated. In addition five 
technical meetings were held with organi sations representing farmers, breeders and 
the 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 of which 360 replied
7.  
Two Eurobarometer surveys addressed cloning: a 2008 specific survey on cloning8 
performed in 27 Member States and a 2010 survey on biotechnology9 with specific 
questions on cloning performed in 27 Me mber States and 5 non-Union European 
countries. 
                                                 
7 Of which: 34 came from professional organisations, 34 from non-governmental organisations,16 from 
national administrative bodies, 1 fr om a third country, 9 from enterprises, 26 from the academia, 10 
from Member States and 230 from individuals. 
8 European attitudes towards animal cloning http:// ec.europa.eu/public_opinion/flash/fl_238_en.pdf and 
http://ec.europa.eu/food/food/resources/docs/eurobarometer_cloning_sum_en.pdf 
9 Special Eurobarometer, Biotechnology report, October 2010  
http://ec.europa.eu/public_opinion/archives/ebs/ebs_341_en.pdf EN 4   EN The specific report on cloning by the European Group on Ethics in Science and New 
Technologies (EGE) of 200810 expressed doubts that animal cloning for farming 
purposes can be justified " considering the current leve l 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 ". 
2.1.2. Summary of responses and how they  have been taken into account 
Member States confirmed that animals ar e presently not cloned for faming purposes 
in the Union. The economic sectors involve d (farming and breeding) indicated that 
they have, at this time, no interest to  produce animals for farm purposes though 
cloning. Farmers and breeders however stressed that to remain competitive they need 
to have access to high performance gene s including the reproductive material of 
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 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 pr e-market approval. Argentina, Australia, 
Brazil, Canada, New Zealand, Paraguay an d the United States pointed out that 
measures should be science-based. They more over stressed that measures should be 
no more trade-restrictive than necessary to fulfil legitimate objectives. 
Union citizens, on the other hand, held a br oadly negative perception of the use of 
the cloning technique for the production of animals for farming purposes. 
This initiative takes account of  the results of the consulta tions. It addresses justified 
concerns in a proportionate manner and cons iders the limits of the powers conferred 
to the Commission by the Treaties. This implies limiting the measures to the animals 
concerned (i.e. the surrogate mothers and th e clones) and the species likely to be 
cloned (bovine, porcine, caprine, ovine  and equine) for farming purposes. 
2.1.3. External expertise 
In 2008 the European Food Safety Aut hority (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-dat ed by three statem ents in 2009, 2010 and 
2012
11. Based on the available data EFSA sa w animal welfare problems related to 
the health of surrogate mothers (carryi ng the clones) and the clones themselves. 
Surrogate dams suffer in particular fr om 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 severa l dams to obtain one clone. In addition, 
clone abnormalities and unusually large offspring result in difficult births and 
                                                 
10 Ethical aspects of animal cloning for food supply 16 January 2008:  
http://ec.europa.eu/bepa/european-group-ethics/docs/publications/opinion23_en.pdf  
http://ec.europa.eu/bepa/european-group-ethics/docs/publications/opinion23_en.pdf 
11 Food safety, animal health and welfare and environmental impact of animals derived from cloning by 
SCNT and their offspring and products obtained from those animals (opinion and statements):  
http://www.efsa.europa.eu/en/efsajournal/doc/767.pdf; http://www.efsa.europa.eu/en/efsajournal/doc/319r.pdf; 
http://www.efsa.europa.eu/en /efsajournal/doc/1784.pdf; 
http://www.efsa.europa.eu/en /efsajournal/doc/2794.pdf EN 5   EN neonatal death. A high mortalit y 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 assessment12 
Based on the experience gained in the legi slative procedure which failed in March 
2011 and the positions expresses by stakeh olders, four options were assessed13. As a 
result of the analysis of the four opti ons, and considering their impacts and the 
objectives pursued, elements of Option 4 (i .e. temporary suspension of the technique 
and of imports of live clones)  were retained as the ba sis of the present proposal. 
Suspending the use of the te chnique and the marketing of  animal clones for farming 
purposes ensures that all Union farmers and breeders are subject to the same 
conditions while adequately protecting animal welfare. To preserve the 
competitiveness of Union farmers, the proposal does not regulate reproductive 
material of clones. 
3. LEGAL  ELEMENTS  OF THE  PROPOSAL 
3.1. Legal basis  
The proposal is based on Article 43 TFEU (agriculture). The objectives of the 
Union's agricultural policy enumerated in Article 39 TFEU require ensuring, 
amongst others, the rational development of agri cultural production. This implies 
ensuring uniform conditions of production for farmers. In choosing the means to 
achieve these objectives, account must also be taken of Article  13 TFEU. Article 13 
TFEU requires that in formulating and im plementing of, amongst others, the Union's 
agriculture policy that the Union and the Member States pay full regard to the welfare requirements of animals since they are sentient beings. 
3.2. Subsidiarity principle 
Isolated approaches to animal cloning coul d lead to distortions of the agricultural 
markets concerned. It is thus necessary to ensure that the same conditions apply and 
thus to address the matter at Union level. 
3.3. Proportionality principle 
The suspension of the cloning technique and the suspension of im ports of live clones 
are suitable and necessary measures to achie ve the objectives. They also present the 
best cost-benefit ratio to resolve the issues at stake.  
At its present state of development it app ears that the use of the cloning technique for 
farming purposes is of limited benefit. Fo r this reason, this proposal addresses only 
those aspects related to animal producti on for farming purposes. It does not cover 
other areas where cloning can be justified due to a positiv e risk-benefit ratio (such as 
research or the use of repr oductive material of clones). 
The suspension of the cloning technique and of imports of animal clones for farming 
purposes thus strikes a reason able fair balance between animal welfare, citizens' 
concerns and the interests of farmers, breeders and other stakeholders involved. 
                                                
 
12 See for further details the accompanying Impact assessment Commission Staff working document SEC 
(2013) XXX. 
13 (1) no policy change, (2) pre-market approval of food from clones, offspring and descendants, 
(3) labelling of food from clones, offspring and descendants, (4) suspension of the cloning techniques 
and of imports of live clones, of food from clones and of reproductive material of clones. EN 6   EN 3.4. Choice of instruments 
The proposed instrument is a Directive. Other types of measures would not be 
appropriate for the following reasons: 
(i) a directive allows Member States em ploy existing control to ols 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, Me mber States have undertaken to 
accompany, only in justified cases, the notif ication of their transposition measures 
with one or more explanatory document s explaining the rela tionship between the 
components of a directive and the corres ponding 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. 
4. BUDGETARY
 IMPLICATION 
This initiative has no budgeta ry implications for the EU and requires no additional 
human resources in the Commission. EN 7   EN 2013/0433 (COD) 
Proposal for a 
DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
on the cloning of animals of the bovine, po rcine, ovine, caprine and equine species kept 
and reproduced for farming purposes 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Article 43(2), 
Having regard to the proposal from the European Commission, 
Having regard to the opinion of the Eu ropean Economic and Social Committee, 
After transmission of the proposal  to the national Parliaments, 
Acting in accordance with the or dinary legislative procedure, 
Whereas: (1) Council Directive 98/58/EC
14 lays down general minimum welfare standards for 
animals bred or kept for farming purposes . It calls on Member States to avoid 
unnecessary pain, suffering or injury of fa rm animals. If cloning causes unnecessary 
pain, suffering or injury, Member States ha ve to act at national level to avoid it. 
Different national approaches to animal cloni ng could lead to market distortion. It is 
thus necessary to ensure that the same  conditions apply to all involved in the 
production and distribution of liv e animals throughout the Union. 
(2) The European Food Safety Authority (EFSA ) has confirmed that surrogate dams used 
in cloning suffer in particular from placen ta dysfunctions contributing to increased 
levels of miscarriages15. This contributes, amongst other things, to the low efficiency 
of the technique, 6 to 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 re sult in difficult births and neonatal 
deaths. 
(3) Taking into account the objectives of the Un ion's agricultural polic y, the results of the 
recent scientific assessments of EFSA and the animal welfare requirement provided in 
Article 13 of the Treaty, it is prudent to provisionally prohibit the use of cloning in 
animal production for farm purposes of certain species. 
(4) Currently animals of bovine, porcine, ovine , caprine and equine species are likely to 
be cloned for farming purposes. The scope of this Directive should therefore be 
limited to the use of cloning for farm ing purposes of those five species. 
                                                
 
14 Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming 
purposes (OJ L 221, 8.8.1998, p. 23). 
15 Scientific Opinion of the Scientific Committee on Food Safety, Animal Health and Welfare and 
Environmental Impact of Animals derived from Cloning by Somatic Cell Nucleus Transfer (SCNT) and 
their Offspring and Products Obtained from those Animals  
http://www.efsa.europa.eu/en/t opics/topic/cloning.htm?wtrl=01 EN 8   EN (5) It is expected that the kn owledge on the impact of the cl oning technique on the welfare 
of the animals used will increase. The cl oning technique is lik ely to improve over 
time. Consequently prohibitions should onl y apply provisionall y. This Directive 
should therefore be reviewed within a reasonable time taking into account the 
experience gained by the Member States in its implementation, scientific and technical 
progress and international developments. 
(6) This Directive respects the fundamental ri ghts and observes the principles recognised 
by the Charter of Fundamental Rights of the European Union, and notably the freedom to conduct a business and the freedom of th e sciences. This Directive has to be 
implemented in accordance with these rights and principles. 
HAVE ADOPTED THIS DIRECTIVE: 
Article 1  
Subject matter and scope 
This Directive lays down rules on: 
(a) the cloning of animals in the Union; (b) the placing on the market of embryo clones and animal clones. 
It shall apply to animals of the bovine, por cine, ovine, caprine and equine species ('the 
animals') kept and reproduced for farming purposes. 
Article 2  
Definitions 
For the purposes of this Directive, the following definitions shall apply: 
(a) animals "kept and reproduced for farming purposes" means animals kept and 
reproduced for the production of food, wool , skin or fur or for other farming 
purposes. It shall not include animals ke pt and reproduced exclusively for other 
purposes such as research, the production of medicinal products and medical devices, 
the preservation of rare br eeds or endangered species, sp orting and cultural events; 
(b) "cloning" means asexual reproduction of  animals with a technique whereby the 
nucleus of a cell of an individual animal is  transferred into an oocyte from which the 
nucleus has been removed to create gene tically identical individual embryos 
("embryo clones"), that can subsequently be implanted into surrogate mothers in 
order to produce populations of genetica lly identical animals ("animal clone"); 
(c) "placing on the market" means the first ma king available of an animal or a product 
on the internal market.  
Article 3 
Provisional prohibition 
Member States shall provisionally prohibit: 
(a) the cloning of animals; (b) the placing on the market of animal clones and embryo clones. EN 9   EN Article 4 
Penalties 
Member States shall lay down the rules on pena lties applicable to infringements of the 
national provisions adopted pursua nt to this Directive and shall take all measures necessary to 
ensure that they are implemented. The penalties provided for must be e ffective, proportionate 
and dissuasive. Member States shall notify those provisions to th e Commission by [date for 
transposition of the Directive] at the late st and shall notify it without delay of any 
subsequent amendment affecting them.’ 
Article 5 
Reporting and Review 
1. By [date = 5 years after the date of tran sposition of this Directive], the Member 
States shall report to the Commission on the experience gained by them on the 
application of this Directive. 
2. The Commission shall present a report to the European Parliament and the Council 
on the application of this Di rective taking into account: 
(a) the reports submitted by Member States in accordance with paragraph 1; (b) scientific and technical progress, in particular relating to the animal welfare 
aspects of cloning; 
(c) international developments.  
Article 6 
Transposition 
1. Member States shall bring into force the laws, regulations and administrative 
provisions necessary to comply with this Directive by [date = 12 month after the date 
of transposition of this Directive]. They shall forthwith communicate to the 
Commission the text of those provisions. 
When Member States adopt those provisions,  they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official 
publication. Member States shall determin e how such reference is to be made. 
2. Member States shall communicate to the Commission the text of the main provisions 
of national law which they adopt in th e field covered by this Directive.  
Article 7  
Entering into force 
This Directive shall enter into  force on the twentieth day follo wing that of its publication in 
the Official Journal of  the European Union .  EN 10   EN Article 8 
Addressees 
This Directive is addressed to the Member States. 
Done at Brussels, [Date]. 
For the European Parliament For the Council 
The President The President