EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, 18.12.2013  
COM(2013) 893 final 
2013/0434 (APP) 
  
Proposal for a 
COUNCIL DIRECTIVE 
on the placing on the market of food from animal clones 
{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 pr e-market approval based on a 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 the propos al was not adopted by 
the co-legislators after the Conciliation failed in March 2011. As a result the 
Commission was asked to prepare a legi slative proposal on cloning in food 
production based on an impact assessment  outside the Novel Food Regulation4. 
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 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 addre ss consumer perceptions  on the use of food 
from animal clones. 
1.3. Regulatory framework 
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 ne w techniques can only be marketed after specific 
authorisation. Such pre-mark et approval must be based on a favourable assessment 
                                                
 
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 14.01.2008.  
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  
EN 3   EN 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. 
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, breeders or food busin ess operators established in the Union and 
in third countries. The proposal envisage s a suspension on Union territory of the 
marketing of food from clones. 
The provisional prohibitions of the marke ting 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 meas ure. The provisional prohibition of the 
marketing of food from clones is also kept  under review to take account of potential 
changes in consumer percepti ons on cloning linked to an imal welfare concerns and 
of international developments. 
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 ountries 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 activis ts) 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 approxim ately 6000 subscribers with 360 replied
6.  
Two Eurobarometer surveys addressed cloning: a 2008 specific survey on cloning7 
performed in 27 Member States and a 2010 survey on biotechnology8 with specific 
questions on cloning performed in 27 Me mber States and 5 non-Union European 
countries.  
                                                 
6 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. 
7 European attitudes towards animal cloning http ://ec.europa.eu/food/resources/docs/eurobarometer 
cloning 
8 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 20089 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 food production 
in the Union. The economic sectors i nvolved (farming, breed ing, 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 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, hold a br oadly 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 consulta tions. It addresses justified 
concerns in a proportionate manner and cons iders the limits of the powers conferred 
to the Union by the Treaties. 
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 
201210. 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 neonatal death. A high mortality rate is a characteristic of the cloning technique.  
On the other hand EFSA repeatedly stated th at cloning has no impact on the safety of 
meat and milk obtained from the clones. 
                                                
 
9 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 
10 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/e fsajournal/doc/1784.pdf;  
http://www.efsa.europa.eu/en /efsajournal/doc/2794.pdf  
EN 5   EN 2.2. Impact assessment11 
Based on the experience gained in the legi slative procedure which failed in March 
2011 and the positions expressed by stakeholders, four options were assessed. Option 4 included, among others, the temporary susp ension 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 insi gnificant as FBOs have no interest to market 
food from clones. 
This option has a positive impact on citizen s: their concerns about animal welfare 
will be addressed as no food from clones will be placed on the market in the Union. 
3. LEGAL
 ELEMENTS  OF THE  PROPOSAL 
3.1. Legal basis  
The Treaty does not provide, for the adoption of this Directive,  powers other than 
those under Article 352. This Directive a ddresses animal welfare concerns of 
consumers related to the use of a repr oduction 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 intere st of consumers when adopting measures 
under Article 114 in the contex t 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 ar e 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 intern al market. Recourse to that pr ovision is also possible if the 
aim is to prevent the emergence of such  obstacles to trade resulting from the 
divergent development of national laws. Ho wever, 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 diverg ence between national legislations was 
detected. Moreover, d
uring 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 . 
3.2. Subsidiarity principle 
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. 
                                                 
11 See for further details the accompanying Impact assessment Commission Staff working document SEC 
(2013) XXX. 
12 See for example C-58/08 Vodafone [2010] ECR p. I-4999, paragraphs 32 and 33 and the case-law cited.  
EN 6   EN 3.3. Proportionality principle 
Animal cloning in food pr oduction 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 a nd the marketing of live clones (animal 
clones) proposed in a parallel measure a nd thus strikes a reas onable fair balance 
between animal welfare, citizens' concerns and the interests of farmers, breeders and 
other stakeholders involved. 
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 2013/0434 (APP) 
Proposal for a 
COUNCIL DIRECTIVE 
on the placing on the market of food from animal clones 
THE COUNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty on the Functioning of the European Union, and in particular 
Article 352(1) thereof, 
Having regard to the proposal from the European Commission, 
After transmission of the draft legislative act to the national Parliaments, After obtaining the consent of the European Parliament,  Acting in accordance with a sp ecial legislative procedure, 
Whereas: (1) Food from animal clones, as food deri ved from a new reproduction technique, falls 
within the scope of the Regulation (EC) No 258/97 of the European Parliament and the 
Council
13 and is thus subject to pre-market approval. 
(2) An opinion of the European Food Safety Authority (EFSA) first adopted on 15 July 
2008 and confirmed in 2009, 2010 and 201214 found no indication of any differences 
in food safety between food products from healthy animal clones and their progeny 
compared with those from healthy conventi onally bred animals. However, EFSA also 
concluded that animal welfare problems related to the health of surrogate mothers, namely those carrying the clones, and the clones themselves exist
15. EFSA concluded 
that surrogate dams suffer in particular from placenta dysfunctions contributing to 
increased levels of miscarriages. This co ntributes, amongst othe r things, to the low 
efficiency of the cloning technique, whic h is 6% to 15 % for animals of the bovine 
species and 6 % for animals of the 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 diffi cult births and neonatal deaths. A high 
mortality rate is a characteri stic of the cloning technique.   
                                                
 
13 Regulation (EC) N° 258/97 of the European Parliament and the Council of 27 January 1997 concerning 
novel foods and novel food ingredients (OJ L 43, 14.2.1997, p. 1). 
14 Scientific Opinion of the Scientific Committ ee 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 
15 Opinion and statements on 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:  
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 8   EN (3) The specific report on cloning by the Eur opean Group on Ethics in Science and New 
Technologies (EGE) of 200816 expressed doubts that animal cloning for food 
production purposes can be justified "consid ering the current level of suffering and 
health problems of surrogate dams and animal clones". 
(4) The majority of Union citizens disappr ove of cloning for f ood production due to 
animal welfare and general ethical concer ns. They do not want to consume food from 
animal clones.  
(5) The use of cloning technique and the placi ng on the market in the Union of embryo 
clones and animal clones for farming pur poses is provisionally prohibited by the 
Directive [number] of the Europe an Parliament and of the Council  on the cloning of 
animals of the bovine, porcine, ovine, caprine  and equine species kept and reproduced 
for farming purposes17. However, this prohibition does not apply to animals kept and 
reproduced exclusively for other purposes.  
(6) In order to address consumer percep tions on cloning linked to animal welfare concerns 
it is necessary to en sure that food from animal clone s does not ente r the food chain. 
Less restrictive measures, such as food labe lling, would not entire ly address citizens' 
concerns since the marketing of food produced  with a technique th at implies animal 
suffering would still be allowed.  
(7) Animal cloning is allowed in certain thir d countries. Therefore, measures should be 
taken to avoid the import into the Union of food obt ained from animal clones 
produced in those third countries.  
(8) It is expected that the knowledge on the impact of cloning technique on animal welfare 
will increase. The cloning technique itself may improve over time and thus become more acceptable to consumers.  
(9) The measures laid down in this act should be reviewed within a reasonable period of 
time to evaluate whether they adequately address the objectives  pursued by it taking 
into account the experience gained by the Me mber States in the application of this 
Directive, consumer perceptions on cloning  linked to animal welfare concerns and 
international developments.  
(10) The Treaty does not provide, for the adop tion of this Directive, powers other than 
those under Article 352. This Directive ad dresses animal welfare concerns of 
consumers related to the use of a reproduc tion technique that has no impact on the 
safety or quality of the food produced but implies animal suffering. Article 169 of the 
Treaty calls on the Union to promote the interests of consum ers when adopting 
measures pursuant to Article 114 thereof in the context of the completion of the internal market. Article 13 of the Treat y, provides that in formulating and 
implementing the Union's internal market pol icy, the Union and the Member States are 
to pay full regard to the welfare requirements of animals since animals are sentient beings. According to the established case-law of the Court of Justice of the European 
Union, the choice of Article 114 of the Treaty as a legal basis is justified where there 
are differences between national rules which are such as to hinde r the functioning of 
the internal market. Recourse to that provisi on is also possible if the aim of the act is 
to prevent the emergence of such obstacles  to trade resulting from the divergent 
                                                
 
16 Ethical aspects of animal cloning for food supply 16 January 2008:  
http://ec.europa.eu/bepa/european-group-ethics/docs/publications/opinion23_en.pdf 
17 [to be completed when text is adopted].  
EN 9   EN development of national laws18. 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 betw een national legislations was detected. 
(11) This Directive respects the fundamental rights and observes the principles recognised 
by the Charter of Fundamental Rights of the European Union, and notably the freedom to conduct a business. This Di rective has to be implemented  in accordance with these 
rights and principles. 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Subject matter 
This Directive establishes rules for the placi ng on the market of food from animal clones. 
Article 2 
Definitions 
For the purposes of this Directive, the following definitions shall apply: 
(a) "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 genetically identical anim als ('animal clones').  
(b) "Food" means food as defined in Ar ticle 2 of Regulation (EC) No 178/2002
19.  
Article 3 
Provisional prohibitions 
1. Member States shall ensure that food from animal clones is not placed on the market.  
2. Member States shall ensure that food of animal origin imported from third countries 
where food from clones can be legally pl aced on the market or exported is only 
placed on the market of the Union according to any specific import conditions 
adopted under Articles 48 and 49 of Regul ation (EC) No 882/ 2004 of the European 
Parliament and of the Council, ensuring that no food from animal clones will be 
exported to the European Union from these third countries.  
                                                 
18 See for example C-58/08 Vodafone [2010] ECR p. I-4999, paragraphs 32 and 33 and the case-law cited. 
19 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying 
down the general principles and requirements of food law, establishing the European Food Safety 
Authority and laying down procedures in matters of food safety, OJ L 31, 1.2.2002, p. 1.  
EN 10   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 t hose provisions to the Commission by [date for 
transposition of the Dir ective] at the latest and shall notify it wit hout 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) changes in consumer perception on cl oning linked to animal welfare concerns; 
(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 months after the date of adoption 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 the field covered by this Directive. 
Article 7 
Entry into force 
This Directive shall enter into force on the tw entieth day following that of its publication in 
the Official Journal of  the European Union . 
It shall apply from [date = 18 months after the date of adoption of th is Directive].   
EN 11   EN Article 8 
Addressees 
This Directive is addressed to the Member States. 
Done at Brussels, 
 For the Council 
 The President