EN    EN EN 
EN    EN  EUROPEAN COMMISSION 
Brussels, 19.10.2010 
COM(2010) 585 final 
  
REPORT FROM THE COMMISSION TO  THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 
on animal cloning for food production 
EN 2   EN REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT 
AND THE COUNCIL 
on animal cloning for food production 
TABLE OF CONTENTS 
1. INTRODUCTION........................................................................................................ 3 
2. ANIMAL WELFARE ISSUES.................................................................................... 4 3. ETHICS...................................................................................................................... .. 5 
4. SITUATION IN THE MEMBER STATES................................................................. 6 5. SITUATION IN THIRD COUNTRIES....................................................................... 7 6. PUBLIC PERCEPTION AND STAKEHOLDER OPINIONS................................... 8 7. TRADE ISSUES .......................................................................................................... 9 8. LEGAL ASPECTS TO BE TAKEN INTO ACOUNT IN THE RISK 
MANAGEMENT....................................................................................................... 10 
9. OPTIONS ................................................................................................................... 12  
10. CONCLUSIONS........................................................................................................ 14 
EN 3   EN 1. INTRODUCTION 
This report presents an assessment of  cloning technology in relation to food 
production. The objective is to examine the rele vant aspects of cloning in light of the 
current legislative framework. 
Cloning1 is a relatively new breeding t echnique which allows the asexual 
reproduction of animals that have shown good productivity, low incidence of disease 
and the capacity to cope with the producti on environment. The scope of the report is 
limited to animals when raised for food production. The animal which is obtained (the clone) is a near exact genetic copy of the original animal. As with any other 
breeding technique, it is important to undertak e risk assessments on critical aspects in 
order to address possible risks as regards food safety and the health and welfare of 
animals. This report also examines other as pects, such as the ethical dimension, trade 
implications and the consumer's right to be  informed about the production process.  
An opinion of the European Food Safety Authority (EFSA) adopted on 15 July 
2008
2, cited difficulties in relation to the risk assessment of cloning due to the limited 
number of available studies. It also noted that the health and welfare of a significant 
proportion of clones had been f ound to be adversely affecte d, often severely and with 
a fatal outcome. The opinion found no indicati on of any differences in food safety for 
the meat and milk of clones and their pr ogeny compared with conventionally bred 
animals. Finally, the opinion did not e nvisage environmen tal impacts, but 
acknowledged the limited availability of data.  
On 26 June 2009, EFSA published a statement on further advice on the use of animal 
cloning3. This statement confirmed the validity of the conclusions and 
recommendations of the 2008 EFSA opinion, adding that the main source of the 
adverse effects that may affect clones a nd result in developmental abnormalities was 
"epigenetic dysregulation"4. Failure of the placental development following cloning 
is believed to be one of the reasons why the technique has a low success rate. 
Adverse affects, however, vary between species. For example, large offspring 
syndrome (LOS) affects cattle but not pigs. Th is condition can result in difficult birth 
and health problems for the surrogate dams and cases of stillbirt h. Neither of these 
phenomena appears to affect the offspr ing of clones, born through conventional 
breeding techniques. 
The EFSA statement of 2009 also noted that  if the success rate of the epigenetic 
reprogramming were to be improved it is likely that the incidence of pathologies and mortalities would decrease.  
                                                
 
1 For the purposes of this report (and in common with EFSA and EGE Opinions) “cloning” refers to 
replication by somatic cell nuclear transfer (SCNT)  to create genetic replicas (clones) from adult 
animals that share the same nuclear gene set as another organism. This report does not cover embryo 
splitting or any form of genetic modification. 
2 http://www.efsa.europa .eu/EFSA/efsa_locale-1178620753812_1211902019540.htm 
3 http://www.efsa.europa.eu/cs/BlobServer/Statm_of _Efsa/sc_statementej_RN319_en.pdf?ssbinary=true 
4 "Epigenetics" seeks to describe the inheritance of information on the basis of gene expression. 
Epigenetic changes in reprogramming of the donor’s nucleus in SCNT have been implicated in causing 
many of the observed anomalies.  
EN 4   EN Japanese research institutes have been  studying animal cloning since 1998. Living 
clones and their progeny provide  important data allowing an alysis of the health and 
welfare status of those animals. Betw een July 1998 and September 2009, 575 cloned 
cattle were born in Japan of wh ich 55% died shortly after birth5. 
In May 2010, the Commission asked EFSA fo r a further update of the scientific 
assessment of cloning: The EFSA statem ent of September 2010 indicated that: 
"Being a genetic copy of its cell donor, the clone has similar potential productive 
performances. It should be stressed that  besides quantitative/ qualitative traits of 
animal products, today’s sele ction strategies take into  account other relevant 
parameters, including resistance to th e common pathologies (e.g. mastitis, other 
infectious and parasitic diseases), fert ility, mentality and ot hers related to the 
general robustness of the animal. Breeding out such complex traits using the traditional selection schemes is time consuming and might tu rn out to be complicated 
and the success is not certain. Cloning could contribute to address these issues in a 
more rapid manner." 
Concerning genetic diversity, th e statement indicated that: 
"An argument often voiced is that cloning will decrease genetic diversity. However, if 
used appropriately, in connection with su itable management measures, cloning is not 
expected to adversely affect the gene tic diversity among domestic species." 
2. ANIMAL WELFARE ISSUES 
The available EFSA opinion associates an imal welfare problems with the current 
state of the application of the cloning t echnique. Cloning presents severe welfare 
challenges for clones arising directly fr om its use and also through possible 
exacerbation of the problems caused by selective breeding. 
First of all, as highlighted by EFSA, a large majority of cloned embryos fail to 
develop to term and, for those that do, a significant proportion of the animals die 
during or shortly after bi rth, or over the following days and weeks, from 
cardiovascular failure, respiratory probl ems, liver or kidney failure, immuno-
deficiencies or musculoskeletal abnormalities. Significantly, EFSA stresses that: “the 
mortality rate of clones is considerably  higher than in sexually produced animals”  
and that there is “evidence of increased morbidity of  clones compared with sexually 
produced animals” .  
Based on the available data, the overall success rate of the cloning procedure 
(measured as the percentage of live cl ones born from the number of embryos 
transferred) is less than 10% in bovine animals and between 5 and 17% in pigs. 
Studies undertaken outside Eu rope have shown that the survival of the progeny of 
clones does not differ to any significant exte nt from the survival of conventionally 
bred animals (around 85%).  
                                                
 
5 Dr. Shinya Watanabe, National Institute of Livestock and Grassland Science, Japan. 
EN 5   EN In its opinion, EFSA also highlighted important welfare issues for surrogate cattle 
dams which suffer from late gestational loss es, more difficult delivery (dystocia) and 
large offspring. Additional welfare concerns ar e related to the fact  that clones may be 
born unusually large and with a range of asso ciated health problems, termed “large 
offspring syndrome” (LOS). This is a co mmon problem in cattle and sheep clones, 
but not in pigs. It should be noted that some abnormalities may not show up until 
later in life. Writing in the OIE Revue Scientifi que et Technique  a leading cloning 
scientist pointed out that the developmen t of musculoskeletal problems, such as 
chronic lameness and severely contracted flexor tendons, in th ese high-production 
animals “ emphasises the point that any underlyi ng frailties in cloned animals may 
not be fully revealed until the animals are stressed in some manner .”6 
In order to correctly assess the impact of cloning on the welfare of farm animals, it is 
important to consider the ways in which cloning is likely to be used within the 
livestock sector. Whilst the cloning of th e fastest growing and high yielding animals 
may lead to higher proportion of animals suffering from such health and welfare 
problems, the cloning of conventionally bred  animals, which are resistant to certain 
diseases or which can easily adapt to difficult environmental conditions, may have 
some possible benefits from a welfare point of view.  
3. ETHICS 
The European Group on Ethics in Scienc e and New Technologies (EGE) published a 
report on the ethical aspects of animal cloning for food production in January 20087.  
The EGE expressed doubts on the ethical justification of cloning animals for food 
production purposes, " considering the current level of  suffering and health problems 
of surrogate dams and animal clones ". The EGE also concluded that the issue of 
ethical justification on the pr ogeny of clones was open to fu rther scientific research 
and did " not see convincing arguments to just ify the production of food from clones 
and their offspring ". 
The basic ethical issue raised by EGE concerns  the moral status that people attribute 
to animals. The position of society on this issue has broadly evolved along two lines: either animals were seen as mere possessions by their owners and available to them for any purposes that they saw fit, or anim als were given respect in varying degrees. 
These attitudes were influenced strongly by cultural and religious traditions. 
Actions causing pain to moral subject s are considered mo rally problematic. 
Therefore, if cloning or any other breedi ng or farming technique affects animal 
welfare and health, then this use is difficu lt to accept. Such theories have advocated 
the possible use of animals only under specific conditions where animal pain is minimised and authorised in well-justified circumstances
 based on the 3Rs 
(reduction, refinement and replacement) pr inciple and on the five freedoms as 
defined by the Farm Animal Welfare C ouncil (FAWC): freedom from (1) hunger, 
                                                 
6 Wells DN. 2005. Animal cloning: problems and prospects. Revue Scientifique et Technique 
(International Office of Epizootics) 24(1):251-64. 
7 http://ec.europa.eu/european_group_ethics/activities/docs/opinion23_en.pdf 
EN 6   EN thirst and malnutrition; (2) fear and distre ss; (3) physical and thermal discomfort; (4) 
pain, injury and disease; and (5) freedom to express normal patterns of behaviour. 
Another theory defends an even stricter line, advocating that animals have a moral 
value in themselves as "subjects-of-life" (intrinsic value argument) and states that both human and non-human beings are (anal ogously) moral entities because of their 
sentient capacities. The corollary of this argument is not to use animals for human 
purposes. Therefore, there is opposition to animal bio-engineering on the basis of 
categorical arguments.  
Another ethical issue concerns intellectua l property rights. Patenting in animal 
cloning is so far limited to nuclear transfer techniques. 
4. SITUATION IN THE MEMBER STATES 
Imports, trade and use of products from  clones (food, semen, and embryos) are 
covered by general EU legislat ion. There is no obligation fo r operators or authorities 
to notify the production, trade or import of cl ones or their semen and embryos so it is 
not possible to gain a complete picture of  the overall situati on. However, for meat 
and milk a pre-market authorisation is  mandatory, according to the Novel Foods 
Regulation8. 
Denmark has imposed a national ban on the use of animal cloning for commercial 
purposes. Any exemptions to this ban mu st be approved and must demonstrate a 
benefit taking into account the stress or suffering caused, including considerations of 
animal integrity, instincts and welfare. At th e core of this ban lies the ethical concern 
that this might lead to human cloning, hen ce Denmark is in accordance with the 2005 
United Nations Resolution calli ng on its Member States to " prohibit all forms of 
human cloning inasmuch as they are in compatible with human dignity and the 
protection of human life ".  
Apart from Denmark, no other Member State has any specific legislation on the use 
of cloning. However, some have provisions in  national animal welf are legislation on 
breeding and genetic engineer ing relating to possi ble pain and suffering of animals 
associated with reproducti on techniques. In Denmark, the cloning of animals is 
permitted only if it serves an essential purpo se. Examples of what is considered an 
essential purpose are basic re search, applied research aimed at improving health and 
the environment or creation and breed ing of animals producing substances 
essentially benefiting health and the environment.   
The Commission has received detailed info rmation from some Member States, which 
use cloning technology for research purposes only. The United Kingdom reported three cattle that are the progeny of clone s imported as embryos. Germany reported 
cloned donor bulls, the semen of which has not  yet been used within the EU but has 
already been exported to third countries. France reported that since 1998 a total of 
90 bovines have been born by cloning at the Institut National de Recherche 
Agronomique (INRA). Currently there are 32 living cloned cows. These animals are 
                                                
 
8 Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 
concerning novel foods and novel food ingredients. 
EN 7   EN used only for research purposes and are sla ughtered, as are their descendents, as soon 
as their research use has ended. Their pr oducts are not used as food. In addition, 
30 offspring of bovine clones have been born by artificia l insemination. Males were 
studied until the age of three months and th en killed. Females are reared in order to 
undertake studies. Currently INRA keeps sixteen young females, offspring from 
clones, in the framework of a research programme. 
5. SITUATION IN THIRD COUNTRIES  
The USA is the most advanced country as regards the cloning of animals for food 
production. The situation is also evolving in other countries such as Argentina, Brazil 
and Japan. China has expressed interest in  the technique and has imported clones 
from Australia amongst others. In addition to the Chinese focus on pets, China has also advocated the use of cloning for th e preservation of endangered species.  
A voluntary moratorium for the marketing of food products (meat and milk) from 
clones is in place in the USA. This mora torium does not, however, cover food from 
the offspring of clones nor semen and embr yos from clones. Generally there is no 
specific labelling or monitoring of se men and embryos from clones and their 
offspring. Therefore, it is not  possible to substantiate pr ecise figures on the possible 
export of semen and embryos to the EU, as clone donors of semen are owned by farmers, and cloning companies do not have control over their use.  
In the USA three major companies sell clone s to farmers. Two of the companies put 
in place a voluntary tracking system, giving every clone a unique identification (ID). 
The system does not however  extend to tracking the o ffspring of clones. The 
programme works through the use of a nati onal registry, based on written statements 
of truth and incentives. The ID of the clone  is entered into a registry that can be 
queried and verified by the livestock auc tion market or packer/processor. The US 
companies involved in cloning have cont acted the Commission  services several 
times in order to express their views. The relevant facts can be summarised as 
follows: 
• Regarding the number of clones, th e companies have not provided (for 
commercial or confidentiality reasons ) precise figures but have often 
mentioned "hundreds of pigs" and "thousa nds of cattle". Therefore products of 
offspring of clones have entered the food chain, not only in the US but also in 
other parts of the world (not least in  Brazil where there are five companies 
involved in cloning). 
• Regarding traceability, clones are tracked through a registry, plus there is an 
economic incentive for farmers not to introduce clones in to the food chain. 
However, this tracking is not mandatory, so it cannot be guaranteed that milk 
from clones does not enter the food chain (e ven if it is unlikel y that such milk 
would be used for food purposes). O ffspring from clones are not tracked. 
In Japan, the National Research Institute  assessed the use of cloning technology and 
concluded that the government would not ta ke any regulatory measure (such as prior 
certification or labelling of  imported food from clones and their offspring). However 
the current voluntary moratorium on the do mestic production of food products from 
EN 8   EN clones and their offspring will be retained. Therefore semen of cloned bulls is 
collected and stored but not used for co mmercial purposes. Arge ntina reported that 
cloning is taking place for comm ercial purposes. It has no re gistry for clones. Brazil 
reported that cloning is only taking place fo r research and not food purposes. A draft 
text is being discussed in the Brazilian Se nate and the Ministry of Agriculture is 
expected to present a proposal for the oblig atory registration of animal clones in a 
national database. Canada requ ires pre-market approval on  a case-by-case basis for 
food from clones. The current policy is bei ng reviewed and the Canadian authorities 
are awaiting a scientific opinion on food safety and animal welfare, which is 
expected by the end of 2010. New Zealand has a moratorium establishing that clones 
cannot enter the food chain. In June 2010 the authorities introduced a national 
registry scheme for clones. An official traceability system will also apply.  
Given the differences of approach with our international partners , there is scope to 
further deepen our understanding of th e regulatory frameworks and research 
parameters that guide cloning outside the EU. To this end the Commission will strengthen the dialogue with trading partners in order to  explore the possibility of 
finding common ground for an understanding on cloning.  
6. PUBLIC PERCEPTION AND STAKEHOLDER OPINIONS 
In 2008 the Commission launched an opinion poll
9 (Eurobarometer) to assess public 
attitudes towards animal cloning. The study s howed that a majority of EU citizens, 
whilst having an understanding of the c oncept of animal cloning, had a broadly 
negative perception of its use for food production. Many were concerned about the 
lack of information concerning the long- term consequences of cloning and many 
cited ethical concerns. There was a genera l feeling that the cloning of animals for 
food production purposes would not benefit the consumer, with few believing that 
using cloning for food production would be mu ch more efficient in the long run or 
lower the cost of food pr oducts for consumers.  
However, in contrast to the generally negative perception of cloning, 44% thought 
that cloning can be justified under ce rtain circumstances, such as for the 
improvement of resistance of animals agains t diseases or to preserve rare animal 
species. 
Animal welfare groups have campaigned st rongly against the use of cloning for food 
production in the EU. These groups claim that  animal welfare legislation, provides a 
basis for the prohibition of the technique to prevent detrimental effect to the welfare of the animals. The same animal welfare gr oups stress the need to apply restrictive 
measures to products from the offspring of clones, even if such animals are produced 
through conventional breeding techniques. They consider it essential for the 
offspring of clones to be included in th e EU’s approach to cloning for food. 
According to these organisations, a prohibiti on of the placing on the market of meat 
and milk from clones (but not their offspri ng) would not be enough to restrain the use 
of the technique in Europe. 
                                                
 
9 European attitudes towards animal cloning: http ://ec.europa.eu/public_opinion/flash/fl_238_en.pdf 
EN 9   EN While assessing the situation, the Commi ssion discussed with the EU agri-food 
sector the use of cloning, taki ng into account the in terests of the lives tock sector with 
respect to access to this innovative technology. The Comm ission discussed with the 
Association of European farmers and of European agri-cooperatives (COPA-
COGECA) the possibility of a voluntary mora torium for a limited period of time on 
the use of clones and their offspring. Th e purpose of such a voluntary moratorium 
would be to ensure that future regulator y options would not be compromised by the 
appearance on the EU market of such animals and animal products. However, 
COPA/COGECA10 takes the view that such a mora torium would not be appropriate, 
in particular because there are currently no means, nor controls, first to ensure full 
traceability of imported products and sec ond to legally pursue those who break the 
moratorium.  
The European meat processing industry CLITRAVI11 states that products from 
cloned animals and/or their offspring thereo f are being sold within the EU and that 
setting up a traceability system will be very costly.  
Both Parliament and Council expect the Co mmission to work on a separate proposal 
on all aspects of cloning. In the Pos ition adopted in March 2010 the Council 
extended the Novel Foods pre-market appr oval to food from the offspring (first 
generation) of clones12. The Parliament reiterated, at its July plenary, its request for a 
total ban on the cloning of an imals; on imports of live cl ones and their offspring; on 
the marketing of food from clones and their offspring; and on the import of semen 
and embryos of clones.  
7. TRADE ISSUES 
Breeding of the European bovine herd takes place mainly through artificial 
insemination. This has consequences on trade. Around 2.5% of the bovine semen used in artificial insemination in the EU is imported, of which approximately 99% 
from USA and Canada. According to the da ta available on TRACES (EU system to 
dispatch information set out in veterinary certificates accompanying animal and animal products traded within the EU and imported from third countries), the overall 
number of doses of bovine semen importe d from USA and Canada into the EU in 
2009 was above 1 200 000. These figures are supported by those for the first semester of 2010, with more than 600 000 doses of semen imported from these two 
countries. 
Assuming that 50% of the doses  of semen imported have b een successfully used to 
inseminate cows in the EU in 2009, this means that around 600 000 calves born in the EU in 2010 are progeny of US or Cana dian bulls. This amounts to approximately 
2% of the calves born each year in the EU . There is no information about the number 
of doses of imported semen coming from cloned bulls.  
Imports of embryos for embryo transfer a nd of breeding animals also take place. 
747 consignments of bovine embryos we re imported into the EU in 2009.  
                                                
 
10 http://www.copa-cog eca.be/Main.aspx?page=search&lang=en 
11 http://www.clitravi.eu/ 
12 Reference COM (2007) 872 of 7 January 2008 
EN 10   EN Imports of live bovines are much less comm on. In the first semester of 2010 only 
24 breeding animals were imported into the EU (from Croatia and Canada)13. 
For live animals, animal products (such as semen and embryos but also wool and 
leather) and food, the following multilatera l agreements of the World Trade 
Organisation (WTO) are relevant: the General Agreement on Tariffs and Trade 
(GATT), the Agreement on the Application of  Sanitary and Phytosanitary Measures 
(SPS) and the Agreement on  Technical Barriers to Trade (TBT). The precise 
determination which of the WTO provisions  are relevant woul d depend (a) on the 
justification and (b) on the nature of  the legislation to be drafted.  
Any measure adopted would have to honour the principle of "National Treatment", 
which prohibits less favourab le treatment of like products imported (Article III:4 
GATT), and the requirement to eliminate quantitative restrictions (Article XI 
GATT). Exemptions from these general ru les can be justified under Article XX of 
GATT ( General Exemptions ) and/or the TBT or SPS agreement. The two latter 
would allow exemptions in line with international standards or based on scientific evidence. The potentially relevant intern ational standard setting bodies for food 
safety (Codex Alimentarius) and animal h ealth (World Organisation for Animal 
Health (OIE)) have not set relevant standards on cloning.  
There is no scientific evidence which coul d justify restrictions  on food from clones 
and food from offspring of clones base d on human health concerns. EFSA has 
however expressed concerns which are related to the welfare of clones. 
The most relevant exemptions from Article  III and XI of GATT would thus be the 
exception on "public morals" which could include animal welfare (paragraph a 
GATT XX) or the protection of  life and health. The WTO exemptions are subject to 
strict requirements, amongst others, proof of  the necessity of the measure to obtain 
the objective in question, which implies that it has to be investigated whether there is 
not a less trade restrictive way to obtain the same objective, as well as proof of 
application in a non-discriminatory, non- arbitrary, non-trade re strictive manner. 
8. LEGAL ASPECTS TO BE TAKEN INTO ACOUNT IN THE RISK 
MANAGEMENT  
Animal Health and Zootechnics 
The applicable law, both veterinary and zootechnical, is based on Article 43 of the 
Treaty of the Functioning of the European Union. The rules do not  distinguish 
between animals produced by different re production technologies (e.g. artificial 
insemination, embryo transfer, embryo splittin g, in-vitro-fertilisation or cloning) as 
from a genetic perspective none of th ese practices affects the genome or 
susceptibility to inf ectious diseases.  
                                                
 
13 Switzerland is not considered here, as in accordance w ith an agreement in place on veterinary issue, it is 
bound to apply EU legislation. Therefore trade in live animals with Switzerland takes place in 
accordance with the rules applying amongst Member States.  
EN 11   EN The basic aim of EU animal h ealth legislation is to contro l infectious diseases. This 
legislation harmonises animal health c onditions governing EU trade and imports 
from third countries. Animals and their products are traded with veterinary 
certificates. The certificates do not cont ain information about the reproduction 
technology by which the animal or (for se men, ova and embryos) the donor animal 
was produced. 
The basic aim of EU zootechnical legislati on is to improve livestock performance by 
rules to ensure free trade and harmonise d conditions for imports of 'pure-bred'  
breeding animals and their genetic material . Pure bred breeding animals are traded 
with pedigree certificates containing the pa rentage of the animal. This legislation 
does not however affect the trade, impor ts or breeding of non pure-bred animals 
(representing some 95% of pigs, sheep and goats, 90% of beef cattle and 50% of dairy cattle).  
EU zootechnical legislation establishes that  pedigree certificates are issued by 
approved breeders’ organisations  or associations to ensu re the ancestry, performance 
and genetic value of pure-bred breeding an imals (bovine, swine, equine, sheep and 
goats) and their semen, ova and embryos that  are traded within the EU or imported 
from third countries. These cer tificates do not foresee that information is given if the 
animals in question are clones/offspring of clones or if they are conventionally bred. 
Animal welfare 
Cloning could be examined in the light of  the provisions of  Council Directive 
98/58/EC concerning the protec tion of animals kept for farming purposes. Paragraph 
20 of the Annex to the Directive states th at: “Natural or artificial breeding or 
breeding procedures which cause or are likely to cause suffering or injury to any of 
the animals concerned must not be practise d.” The same text is included in the 
European Convention for the protection of animals kept for farming purposes, which 
gives principles for the keeping, care and housing of animals, in particular in 
intensive breeding systems. Member States are responsible for the implementation of EU legislation on their terr itory. Furthermore, Article 13 of the Treaty of the 
Functioning of the EU clearly states that animals welfare needs must be fully taken 
into account when drafting and implementing EU policies on agriculture, fisheries, 
transport, internal market, rese arch and development and space.  
Traceability of animals 
In the EU, food producing animals are subjec t to traceability requirements which also 
apply to clones. Individual traceability has been in place for bovine animals since 1997. For sheep and goats, i ndividual traceability bega n in 2010. Pigs have been 
traceable on a batch basis since 1992. The current rules do not foresee a need to 
record on the documents any refe rence to reproduction technology. 
Novel Foods issues 
Food from clones is covered by Regulati on (EC) 258/97 on Novel foods, since such 
food is derived from animals that ar e obtained by non-trad itional breeding 
techniques. This means that these food pr oducts cannot be put on the market without 
a safety assessment and a specific authorising legal act. To date, no application has been made by any company seeking to put food from clones on the market. 
EN 12   EN Legislation on organic farming 
Since 1991, the EU has in place a legislativ e framework relating to the practice of 
organic farming. At first the organic Regulation only regulated plant products. 
Additional provisions for the production of  animal products were later introduced. 
These rules included animal feed, prevention of illness, veterinary treatment, animal 
protection, livestock breeding in gene ral and the use of livestock manure14. 
With regard to breeding, the Regulation st ates that reproduction shall take place 
using natural methods. However artificial insemination is allowed, but any other 
form of artificial reproducti on, such as cloning and embr yo transfer, shall not be 
used. The use of inducing treatments w ith hormones or similar substances is 
forbidden, unless in the form of therapeutic  treatment for an individual animal.  
The EU framework on organic farming pr ovides for the guarantee that food is 
obtained from animals bred without the us e of any "non-traditi onal breeding method" 
such as cloning or embryo transfer.  
9. OPTIONS  
The assessment of the situation shows that it  is scientifically accepted that there are 
no food safety concerns about food produced  from clones or their offspring. The 
risks for animal welfare are however a solid  basis for the Commission to initiate a 
legislative process. To address the con cern that people perceive the cloning of 
animals as morally wrong could be seen as another factor to be taken into account 
under EU law. 
The options are therefore:  
(1) Legal status quo  
 Cloning would continue not to be speci fically regulated at  EU level. Clones 
and their reproductive materials (seme n, ova and embryos) would continue to 
be marketed in the EU under the general rules. Food from clones would still be 
subject to a pre-market authorisation under the Nove l foods Regulation. Food 
from the offspring of clones would cont inue to be covered by generic rules, 
which ensure the safety of those products and the functioning of the single market
15.  
                                                 
14 Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic 
products and repealing Regulation (EEC) No 2092/91. 
15 Treaty of the Functioning of the EU, Art. 34 – 36, General food law Regulation (EC) No 178/2002 on 
the general principles and requirements of food law, Regulation (EC) No 852/2004 on the hygiene of 
foodstuffs, Regulation (EC) No 853/2004 on the specific hygiene rules for food of animal origin. 
EN 13   EN (2) Total prohibition  
• Prohibition of the cloning of fa rm animals for food production : This 
would address the key issue pertaini ng to cloning, namely the welfare 
concerns. Cloning would not be allo wed on EU territory for food 
production purposes.  
• A ban in the EU on the use of clones and of the placing on the market 
of food from clones : This measure, which would also apply to imports 
would ensure coherence with the ban of the cloning technique in the EU.  
• A ban of the placing on the market of offspring of clones and food 
from the offspring of clones: This measure would not  be justified on 
grounds of protecting animal welfare, an imal health or pub lic health in so 
far as there are no welfare concerns fo r the offspring of clones as they are 
produced by normal reproduction techni ques, nor safety concerns for 
food derived from offspring of clon es, as indicated by EFSA. As food 
from the offspring of clones cannot be distinguished from food from 
other animals, a complete traceability system would be needed. This would be extremely burdensome to put in place as it would imply detailed tracing of all generations of  offspring, for the species used for 
food production. Furthermore, such prohi bition would lead to a ban of 
imports of any food of animal or igin (meat, milk  and processed 
products), from third countries wh ich may have imported reproductive 
material from clones. A total ban on the import of food from the offspring of clones would have a considerable and disproportionate 
economic impact on EU agriculture production and trade.  In addition, 
there are no welfare or health or f ood safety concerns to justify such 
action.  
• A ban on the use of reproduc tive material from clones: There are no 
health or food safety concerns linked to the use of conventional breeding techniques, therefore a ban on impor ts of reproductive material from 
clones is difficult to justify.  
(3) Mix of measures 
 The Commission considers that a mix of  measures would meet the concerns 
raised on the issue of cloning. These measures could include:  
• A temporary suspension of the clon ing technique of farm animals for 
food purposes : This option addresses the welfare issues linked to the use 
of the cloning technique for food pr oduction in the EU. As the technique 
may mature and alleviate partially or  fully these concerns, the prohibition 
should be revisited after a certain period.  
• A temporary suspension of the use of cloned farm animals : This is a 
limited measure since imports of live clones are rare and no commercial cloning occurs in the EU. This would ensure coherence with the suspension of the cloning technique. 
EN 14   EN • A temporary suspension of placin g on the market of food from 
clones : This suspension which would appl y also to imports would ensure 
coherence with the ban of the technique in the EU. 
• Traceability of reproductive material:  This would allow farmers and 
the food industry to develop informati on schemes. In order to distinguish 
between (i) semen and embryos from clones and (ii) semen and embryos originating from conventionally bred-a nimals it would be necessary to 
amend certain certification requirement s laid down in the zootechnical 
and animal health legislation. As op erators would be required to mention 
in existing certificates whether or not the reproductive material derives 
from a clone, the administrative burden is limited. Such information is not difficult to retrieve as the gene tic value is usually  requested by the 
purchaser. Further, some trading part ners using the cloning technique for 
food production purposes have already es tablished - or envisage to do so 
- a specific system of compulsory re gistration of clones, which facilitates 
further the traceability of reproductive material. 
10. CONCLUSIONS  
In view of the issues outlined above, and in particular the need to  address the welfare 
concerns linked to the use of the cloning technique and the appropriateness to allow market information, the Commission will propose to: 
(i) Suspend temporarily the use of the techniqu e in the EU for the reproduction of 
all food producing animals; the use of clones of these animals; and the marketing of food from clones.  
(ii) Establish the traceability of imports  of semen and embryos to allow farmers 
and industry to set up data bank( s) of offspring in the EU.  
With a review clause after 5 years, the proposed legislative measure will be based on 
the appropriate legal basis taking into account its content and objective. Cloning 
would however remain possible for all ot her purposes than f ood production such as 
research
16, production of pharmaceuticals or the conservation of endangered species 
or breeds. During the five year period, the Commission will  monitor the scientific 
and technological development of cloning in  order to asses whether, when and under 
which conditions these provisi onal measures co uld be removed. No legal measures 
are proposed in relation to food from the offspring of clones. However, the establishment of the traceability system under (ii) above makes information schemes 
possible.  
                                                
 
16 The use of clones in research must be in compli ance with the Dir ective 86/609/EEC on the protection of 
animals used for experimental and other scientific purposes. 
EN 15   EN The future scenarios can be summarised as follows:  
 Clones Offspring 
 Clone itself Embryo/semen Food products Offspring 
itself Embryo/semen Food 
products 
Produced in 
the EU Temporary 
suspension of the technique 
for food 
production No measure 
As long as the technique is suspended there will  be no products (embryos, semen, food) of clones 
produced in the EU and of their offspring  
Imported in 
the EU Temporary 
suspension of imports of 
clones Traceability 
requirements on exporters to EU Temporary 
suspension of placing on the 
market.  No measure 
The Commission invites the Parliament and the Council to consider the contents and 
conclusions of this report and to ex press their positions in due course.