REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL on animal cloning for food production
Date: 2010-10-19
Institutions: European Commission
Subjects: animal breeding, cloning, food safety, foodstuffs legislation, health risk

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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 

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REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT 
AND THE COUNCIL 

on animal cloning for food production 

TABLE OF CONTENTS 

1. 

2. 

3. 

4. 

5. 

6. 

7. 

8. 

9. 

10. 

INTRODUCTION........................................................................................................ 3 

ANIMAL WELFARE ISSUES.................................................................................... 4 

ETHICS........................................................................................................................ 5 

SITUATION IN THE MEMBER STATES................................................................. 6 

SITUATION IN THIRD COUNTRIES....................................................................... 7 

PUBLIC PERCEPTION AND STAKEHOLDER OPINIONS ................................... 8 

TRADE ISSUES .......................................................................................................... 9 

LEGAL ASPECTS TO BE TAKEN INTO ACOUNT IN THE RISK 
MANAGEMENT ....................................................................................................... 10 

OPTIONS ................................................................................................................... 12 

CONCLUSIONS........................................................................................................ 14 

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1. 

INTRODUCTION 

This  report  presents  an  assessment  of  cloning  technology  in  relation  to  food 
production. The objective is to examine the relevant aspects of cloning in light of the 
current legislative framework. 

Cloning1  is  a  relatively  new  breeding  technique  which  allows  the  asexual 
reproduction of animals that have shown good productivity, low incidence of disease 
and the capacity to cope with the production 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 undertake 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 aspects, 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 
20082, 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 found to be adversely affected, often severely and with 
a fatal outcome. The opinion found no indication of any differences in food safety for 
the  meat  and  milk  of  clones  and  their  progeny  compared  with  conventionally  bred 
animals.  Finally,  the  opinion  did  not  envisage  environmental  impacts,  but 
acknowledged the limited availability of data. 

the  validity  of 

On 26 June 2009, EFSA published a statement on further advice on the use of animal 
cloning3.  This  statement  confirmed 
the  conclusions  and 
recommendations  of  the  2008  EFSA  opinion,  adding  that  the  main  source  of  the 
adverse effects that may affect clones and 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. This condition can result in difficult birth 
and  health  problems  for  the surrogate dams and cases of stillbirth. Neither of these 
phenomena  appears  to  affect  the  offspring  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.  

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2 
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4 

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. 
http://www.efsa.europa.eu/EFSA/efsa_locale-1178620753812_1211902019540.htm 
http://www.efsa.europa.eu/cs/BlobServer/Statm_of_Efsa/sc_statementej_RN319_en.pdf?ssbinary=true 
"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.  

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Japanese  research  institutes  have  been  studying  animal  cloning  since  1998.  Living 
clones and their progeny provide important data allowing analysis of the health and 
welfare status of those animals. Between July 1998 and September 2009, 575 cloned 
cattle were born in Japan of which 55% died shortly after birth5. 

In  May  2010,  the  Commission  asked  EFSA  for  a  further  update  of  the  scientific 
assessment of cloning: The EFSA statement 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  selection  strategies  take  into  account  other  relevant 
parameters,  including  resistance  to  the  common  pathologies  (e.g.  mastitis,  other 
infectious  and  parasitic  diseases),  fertility,  mentality  and  others  related  to  the 
general  robustness  of  the  animal.  Breeding  out  such  complex  traits  using  the 
traditional selection schemes is time consuming and might turn 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, the statement indicated that: 

"An argument often voiced is that cloning will decrease genetic diversity. However, if 
used appropriately, in connection with suitable management measures, cloning is not 
expected to adversely affect the genetic diversity among domestic species." 

2. 

ANIMAL WELFARE ISSUES 

The  available  EFSA  opinion  associates  animal  welfare  problems  with  the  current 
state  of  the  application  of  the  cloning  technique.  Cloning  presents  severe  welfare 
challenges  for  clones  arising  directly  from  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  birth,  or  over  the  following  days  and  weeks,  from 
cardiovascular  failure,  respiratory  problems,  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  clones  born  from  the  number  of  embryos 
transferred)  is  less  than  10%  in  bovine  animals  and  between  5  and  17%  in  pigs. 
Studies  undertaken  outside  Europe  have  shown  that  the  survival  of  the  progeny  of 
clones  does  not  differ  to  any  significant  extent  from  the  survival  of  conventionally 
bred animals (around 85%).  

5 

Dr. Shinya Watanabe, National Institute of Livestock and Grassland Science, Japan. 

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In  its  opinion,  EFSA  also  highlighted  important  welfare  issues  for  surrogate  cattle 
dams which suffer from late gestational losses, more difficult delivery (dystocia) and 
large offspring. Additional welfare concerns are related to the fact that clones may be 
born unusually large and with a range of associated health problems, termed “large 
offspring  syndrome”  (LOS).  This  is  a  common  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  Scientifique  et  Technique  a  leading  cloning 
scientist  pointed  out  that  the  development  of  musculoskeletal  problems,  such  as 
chronic  lameness  and  severely  contracted  flexor  tendons,  in  these  high-production 
animals  “emphasises  the  point  that  any  underlying  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 the 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 Science 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 progeny of clones was open to further scientific research 
and did "not see convincing arguments to justify 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 animals were given respect in varying degrees. 
These attitudes were influenced strongly by cultural and religious traditions. 

Actions  causing  pain  to  moral  subjects  are  considered  morally  problematic. 
Therefore,  if  cloning  or  any  other  breeding  or  farming  technique  affects  animal 
welfare and health, then this use is difficult 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)  principle  and  on  the  five  freedoms  as 
defined  by  the  Farm  Animal  Welfare  Council  (FAWC):  freedom  from  (1)  hunger, 

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Wells  DN.  2005.  Animal  cloning:  problems  and  prospects.  Revue  Scientifique  et  Technique 
(International Office of Epizootics) 24(1):251-64. 
http://ec.europa.eu/european_group_ethics/activities/docs/opinion23_en.pdf 

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thirst and malnutrition; (2) fear and distress; (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 (analogously) 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  intellectual  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 legislation. There is no obligation for operators or authorities 
to notify the production, trade or import of clones or their semen and embryos so it is 
not  possible  to  gain  a  complete  picture  of  the  overall  situation.  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  must  be  approved  and  must  demonstrate  a 
benefit taking into account the stress or suffering caused, including considerations of 
animal integrity, instincts and welfare. At the core of this ban lies the ethical concern 
that this might lead to human cloning, hence Denmark is in accordance with the 2005 
United  Nations  Resolution  calling  on  its  Member  States  to  "prohibit  all  forms  of 
human  cloning  inasmuch  as  they  are  incompatible  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 welfare legislation on 
breeding  and  genetic  engineering  relating  to  possible  pain  and  suffering  of  animals 
associated  with  reproduction  techniques.  In  Denmark,  the  cloning  of  animals  is 
permitted only if it serves an essential purpose. Examples of what is considered an 
essential purpose are basic research, applied research aimed at improving health and 
the  environment  or  creation  and  breeding  of  animals  producing  substances 
essentially benefiting health and the environment.  

The Commission has received detailed information from some Member States, which 
use  cloning  technology  for  research  purposes  only.  The  United  Kingdom  reported 
three  cattle  that  are  the  progeny  of  clones  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. 

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used only for research purposes and are slaughtered, as are their descendents, as soon 
as  their  research  use  has  ended.  Their  products  are  not  used  as  food.  In  addition, 
30 offspring of bovine clones have been born by artificial insemination. Males were 
studied until the age of three months and then 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 the 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 moratorium does not, however, cover food from 
the  offspring  of  clones  nor  semen  and  embryos  from  clones.  Generally  there  is  no 
specific  labelling  or  monitoring  of  semen  and  embryos  from  clones  and  their 
offspring. Therefore, it is not possible to substantiate precise 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 clones 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  offspring  of  clones.  The 
programme works through the use of a national 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  auction  market  or  packer/processor.  The  US 
companies  involved  in  cloning  have  contacted  the  Commission  services  several 
times  in  order  to  express  their  views.  The  relevant  facts  can  be  summarised  as 
follows: 

• 

• 

Regarding  the  number  of  clones,  the  companies  have  not  provided  (for 
commercial  or  confidentiality  reasons)  precise  figures  but  have  often 
mentioned "hundreds of pigs" and "thousands 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  into  the  food  chain. 
However, this tracking is not mandatory, so it cannot be guaranteed that milk 
from clones does not enter the food chain (even if it is unlikely that such milk 
would be used for food purposes). Offspring from clones are not tracked. 

In Japan, the National Research Institute assessed the use of cloning technology and 
concluded that the government would not take any regulatory measure (such as prior 
certification or labelling of imported food from clones and their offspring). However 
the current voluntary moratorium on the domestic production of food products from 

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clones  and  their  offspring  will  be  retained.  Therefore  semen  of  cloned  bulls  is 
collected and  stored but not used  for  commercial purposes.  Argentina reported that 
cloning is taking place for commercial purposes. It has no registry for clones. Brazil 
reported that cloning is only taking place for research and not food purposes. A draft 
text  is  being  discussed  in  the  Brazilian  Senate  and  the  Ministry  of  Agriculture  is 
expected  to  present  a  proposal  for  the  obligatory  registration  of  animal  clones  in  a 
national  database.  Canada  requires  pre-market  approval  on  a  case-by-case  basis  for 
food from clones. The current policy is being 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  the  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 poll9 (Eurobarometer) to assess public 
attitudes towards animal cloning. The study showed that a majority of EU citizens, 
whilst  having  an  understanding  of  the  concept  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  general  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 much more efficient in the long run or 
lower the cost of food products for consumers.  

However,  in  contrast  to  the  generally  negative  perception  of  cloning,  44%  thought 
that  cloning  can  be  justified  under  certain  circumstances,  such  as  for  the 
improvement  of  resistance  of  animals  against  diseases  or  to  preserve  rare  animal 
species. 

Animal welfare groups have campaigned strongly 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 groups 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  the  EU’s  approach  to  cloning  for  food. 
According to these organisations, a prohibition of the placing on the market of meat 
and milk from clones (but not their offspring) would not be enough to restrain the use 
of the technique in Europe. 

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European attitudes towards animal cloning: http://ec.europa.eu/public_opinion/flash/fl_238_en.pdf 

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While  assessing  the  situation,  the  Commission  discussed  with  the  EU  agri-food 
sector the use of cloning, taking into account the interests of the livestock sector with 
respect to access to this innovative technology. The Commission discussed with the 
Association  of  European  farmers  and  of  European  agri-cooperatives  (COPA-
COGECA) the possibility of a voluntary moratorium for a limited period of time on 
the  use  of  clones  and  their  offspring.  The  purpose  of  such  a  voluntary  moratorium 
would be to ensure that future regulatory 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 moratorium would not be appropriate, 
in  particular  because  there  are  currently  no  means,  nor  controls,  first  to  ensure  full 
traceability of  imported products and second to legally pursue those  who break  the 
moratorium.  

The  European  meat  processing  industry  CLITRAVI11  states  that  products  from 
cloned animals and/or their offspring thereof are being sold within the EU and that 
setting up a traceability system will be very costly.  

Both Parliament and Council expect the Commission to work on a separate proposal 
on  all  aspects  of  cloning.  In  the  Position  adopted  in  March  2010  the  Council 
extended  the  Novel  Foods  pre-market  approval  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 animals; on imports of live clones 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 data 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  imported  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 been 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 Canadian 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  and  of  breeding  animals  also  take  place. 
747 consignments of bovine embryos were imported into the EU in 2009.  

10 
11 
12 

http://www.copa-cogeca.be/Main.aspx?page=search&lang=en 
http://www.clitravi.eu/ 
Reference COM (2007) 872 of 7 January 2008 

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Imports  of  live  bovines  are  much  less  common.  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  multilateral  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  would  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  favourable  treatment  of  like  products  imported  (Article  III:4 
GATT),  and  the  requirement  to  eliminate  quantitative  restrictions  (Article  XI 
GATT).  Exemptions  from  these  general  rules  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  international  standard  setting  bodies  for  food 
safety  (Codex  Alimentarius)  and  animal  health  (World  Organisation  for  Animal 
Health (OIE)) have not set relevant standards on cloning.  

There is no scientific evidence which could justify restrictions on food from clones 
and  food  from  offspring  of  clones  based  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 restrictive 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  reproduction  technologies  (e.g.  artificial 
insemination,  embryo  transfer,  embryo  splitting,  in-vitro-fertilisation  or  cloning)  as 
from  a  genetic  perspective  none  of  these  practices  affects  the  genome  or 
susceptibility to infectious diseases.  

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Switzerland is not considered here, as in accordance with 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.  

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The basic aim of EU animal health legislation is to control infectious diseases. This 
legislation  harmonises  animal  health  conditions  governing  EU  trade  and  imports 
from  third  countries.  Animals  and  their  products  are  traded  with  veterinary 
certificates.  The  certificates  do  not  contain  information  about  the  reproduction 
technology by which the animal or (for semen, ova and embryos) the donor animal 
was produced. 

The basic aim of EU zootechnical legislation is to improve livestock performance by 
rules  to  ensure  free  trade  and  harmonised  conditions  for  imports  of  'pure-bred' 
breeding  animals  and  their  genetic  material.  Pure  bred  breeding  animals  are  traded 
with  pedigree  certificates  containing  the  parentage  of  the  animal.  This  legislation 
does  not  however  affect  the  trade,  imports  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 ensure the ancestry, performance 
and  genetic  value  of  pure-bred  breeding  animals  (bovine,  swine,  equine,  sheep  and 
goats) and their semen, ova and embryos that are traded within the EU or imported 
from third countries. These certificates 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 protection of animals kept for farming purposes. Paragraph 
20  of  the  Annex  to  the  Directive  states  that:  “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  practised.”  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  territory.  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, research and development and space.  

Traceability of animals 

In the EU, food producing animals are subject to traceability requirements which also 
apply  to  clones.  Individual  traceability  has  been  in  place  for  bovine  animals  since 
1997.  For  sheep  and  goats,  individual  traceability  began  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 reference to reproduction technology. 

Novel Foods issues 

Food from clones is covered by Regulation (EC) 258/97 on Novel foods, since such 
food  is  derived  from  animals  that  are  obtained  by  non-traditional  breeding 
techniques. This means that these food products 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. 

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Legislation on organic farming 

Since  1991,  the  EU  has  in  place  a  legislative  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 general and the use of livestock manure14. 

With  regard  to  breeding,  the  Regulation  states  that  reproduction  shall  take  place 
using  natural  methods.  However  artificial  insemination  is  allowed,  but  any  other 
form  of  artificial  reproduction,  such  as  cloning  and  embryo  transfer,  shall  not  be 
used.  The  use  of  inducing  treatments  with  hormones  or  similar  substances  is 
forbidden, unless in the form of therapeutic treatment for an individual animal.  

The  EU  framework  on  organic  farming  provides  for  the  guarantee  that  food  is 
obtained from animals bred without the use of any "non-traditional 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  concern  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  specifically  regulated  at  EU  level.  Clones 
and their reproductive materials (semen, 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 Novel foods Regulation. Food 
from  the  offspring  of  clones  would  continue  to  be  covered  by  generic  rules, 
which  ensure  the  safety  of  those  products  and  the  functioning  of  the  single 
market15.  

14 

15 

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. 
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. 

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(2)  Total prohibition  

• 

• 

• 

Prohibition of the cloning of farm animals for food production: This 
would  address  the  key  issue  pertaining  to  cloning,  namely  the  welfare 
concerns.  Cloning  would  not  be  allowed  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, animal health or public health in so 
far as there are no welfare concerns for the offspring of clones as they are 
produced  by  normal  reproduction  techniques,  nor  safety  concerns  for 
food  derived  from  offspring  of  clones,  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  prohibition  would  lead  to  a  ban  of 
imports  of  any  food  of  animal  origin  (meat,  milk  and  processed 
products),  from  third  countries  which  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  food  safety  concerns  to  justify  such 
action.  

• 

A ban on the use of reproductive material from clones: There are no 
health or food safety concerns linked to the use of conventional breeding 
techniques,  therefore  a  ban  on  imports  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 cloning technique of farm animals for 
food purposes: This option addresses the welfare issues linked to the use 
of the cloning technique for food production 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. 

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• 

• 

A  temporary  suspension  of  placing  on  the  market  of  food  from 
clones: This suspension which would apply 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 information schemes. In order to distinguish 
between (i) semen and embryos from clones and (ii) semen and embryos 
originating  from  conventionally  bred-animals  it  would  be  necessary  to 
amend  certain  certification  requirements  laid  down  in  the  zootechnical 
and animal health legislation. As operators 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  genetic  value  is  usually  requested  by  the 
purchaser. Further, some trading partners using the cloning technique for 
food production purposes have already established - or envisage to do so 
- a specific system of compulsory registration 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 technique 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 other purposes than food production such as 
research16, 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  provisional  measures  could  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 compliance with the Directive 86/609/EEC on the protection of 
animals used for experimental and other scientific purposes. 

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The future scenarios can be summarised as follows:  

Clones 

Offspring 

Clone itself 

Embryo/semen 

Food products 

Offspring 
itself 

No measure 

Embryo/semen 

Food 
products 

Produced in 
the EU 

Imported in 
the EU 

Temporary 
suspension of 
the technique 
for food 
production 

Temporary 
suspension of 
imports of 
clones 

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  

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 express their positions in due course. 

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