COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT
Date: 2013-12-18
Institutions: European Commission
Subjects: animal breeding, animal welfare, cattle, cloning, equidae, foodstuff, goat, market approval, marketing standard, sheep, swine













EUR-Lex - 52013SC0519 - EN











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52013SC0519

COMMISSION STAFF WORKING DOCUMENT IMPACT ASSESSMENT /* SWD/2013/0519 final */









Table of Contents
1..... Procedural
issues and consultation of interested parties. 7
1.1.     Introduction. 7
1.2.     Organisation
and timing. 8
1.2.1. Member States. 8
1.2.2. Stakeholders and third countries. 9
1.2.3. Responses to the public consultation “IPM
consultation” & position papers  9
1.2.4. Results of Eurobarometer of 2008 and 2010. 10
1.2.5. Impact Assessment Steering Group (IASG) 10
1.2.6. External expertise. 10
1.3.     Opinion
of the IAB.. 11
2..... Problem
definition.. 12
2.1.     Animal
welfare concerns linked to the use of the cloning technique. 12
2.2.     Concerns
of EU citizens. 13
2.3.     Risk
of diverging national laws on cloning. 13
2.4.     The
underlying drivers. 14
2.5.     Who
is affected, in what ways, and to what extent?. 15
2.6.     Baseline
scenario. 16
2.6.1. EU legal framework. 16
2.6.2. Baseline scenario regarding the farming,
breeding and food sectors. 19
2.6.3. International dimension. 20
2.7.     Does
the EU have the right to act (subsidiarity)?. 23
3..... Objectives. 24
3.1.     General
objective. 24
3.2.     Specific
objectives. 24
3.3.     Consistency
with other EU policies and horizontal objectives. 25
4..... Policy
Options. 25
4.1.     Policy
options included in the analysis. 25
4.2.     Options
discarded at an early stage. 27
5..... Analysis
of Impacts. 28
5.1.
Option 1: No policy change. 28
5.1.1. Description of the option. 28
5.1.2. Economic Impacts. 29
5.1.3. Impacts on consumer protection. 31
5.1.4. Impacts on food prices and employment 31
5.1.5. Impact on Animal Welfare. 32
5.2.
Option 2: Pre-market approval for food from clones, offspring and descendants. 32
5.2.1. Description of the option. 32
5.2.2. Economic Impacts. 33
5.2.3. Impacts on consumer protection. 34
5.2.4. Impact on prices and employment 34
5.2.5. Impact on Animal Welfare. 34
5.3.
Option 3: labelling of food from clones, offspring and descendants. 34
5.3.1. Description of the option. 34
5.3.2. Economic impacts in EU - costs. 35
5.3.3. Economic impacts on trade with third countries. 40
5.3.4. Impacts on consumer protection. 42
5.3.5. Impacts on food prices and employment 43
5.3.6.. Impact on Animal Welfare. 43
5.4.
Option 4: temporary suspension of the technique and of imports of live clones,
their reproductive material and their food. 43
5.4.1. Description of the option. 43
5.4.2. Economic Impacts. 44
5.4.3. Impacts on consumer protection. 46
5.4.4. Impacts on prices and employment 46
5.4.5. Impact on Animal welfare. 46
5.5.
Impacts on control (applicable to all options including non-policy change) 47
6..... Comparing
the Options. 47
6.1.     Comparing
the options in terms of impacts. 48
6.1.1. Option 1 (no policy change) 48
6.1.2. Option 2: Pre-market approval of food from
clones to food from offspring and descendants  48
6.1.3. Option 3: labelling of food (from clones,
offspring and descendants) 48
6.1.4. Option 4: temporary suspension of the technique
and the use of clones (food and reproductive material) 49
6.2.     Comparing
the options in terms of objectives for coherence and efficiency. 49
6.2.1. Option 1 (no policy change) 49
6.2.2. Option 2: Pre-market approval of food from
clones to food from offspring and descendants. 49
6.2.3 Option 3: labelling of food (from clones,
offspring and descendants) 50
6.2.4. Option 4: temporary suspension of the technique
and the use of clones (food and reproductive material) 50
6.3.     Table
summarising the impacts. 51
7..... Monitoring
and Evaluation.. 52
ANNEXES. 53
 Executive Summary Sheet 
 Proposals for Directives of the European Parliament and of the Council on cloning of food producing animals  
 A. Need for action 
 Why? What is the problem being addressed? 
 a) Welfare and health of animals linked to the use of the cloning technique EFSA[1] highlighted that surrogate dams (carrying the clones) and the clones themselves suffer in the application of the technique. b) The negative perception that EU citizens have cloning technique if used for food production In surveys the vast majority (above 80 %) of EU citizens expressed broadly negative perception of the use of cloning technique for food production. This perception appears to be at least partly the result of: -          the unfounded assumption that cloning of food producing animals poses a risk to food safety and human health; -          the false idea that this cloning involves genetic modification; -          general scepticism towards new technologies in biosciences; -          fear that negative effects of cloning manifest themselves only later. c) The request of the co-legislator to address the issue Inter-institutional discussions on cloning started in 2009 in the context of the negotiations on a proposal streamlining the approval process of the 1997 Novel Food Regulation. No agreement could be reached between Member States and the European Parliament on any of the issues linked to cloning. The conciliation failed and the Commission was requested to present a proposal on cloning based on an impact assessment. 
 What is this initiative expected to achieve? 
 General objectives To address concerns on cloning for farming purposes, to ensure uniform conditions for farmers in the EU and to protect consumer interests as regard food from cloned animals. Specific objectives - Objective 1:    To ensure uniform conditions of production of farmers in the EU while protecting health and welfare of farmed animals; - Objective 2:    To protect consumer interests as regards food from cloned animals; - Objective 3:    To safeguard the competitiveness of farmers, breeders and food businesses in the EU 
 What is the value added of action at the EU level?  
 Council Directive 98/58/EC lays down general minimum welfare standards for animals bred or kept for farming purposes. It calls on Member States to avoid unnecessary pain, suffering or injury of farm animals. If cloning causes unnecessary pain, suffering or injury, Member States have to act at national level to avoid it. Yet different national approaches to animal cloning could lead to market distortion. Measures regulating the use of the cloning technique would address the associated animal health and welfare concerns. They would prevent the development of diverging national legislation and the consequent disruptions of the concerned agricultural markets. They would thus also ensure level playing field for breeders and farmers and uniform conditions of production for farmers. As breeding/cloning companies and food operators in third countries are also concerned it is necessary to ensure that the same conditions apply to them. The matter should thus be addressed at Union level. 
 B. Solutions 
 What legislative and non-legislative policy options have been considered? Is there a preferred choice or not? Why? 
 Four legislative policy options have been assessed: (1) the status quo; (2) premarket-approval of food from clones, offspring and descendants; (3) labelling of food from clones, offspring and descendants; and (4) suspension of the cloning technique in the EU (with the suspension of use of clones, their reproductive material and their food). None of the options would on their own enable to attain the objectives. Therefore to define the most appropriate policy approach, elements of options may need to be put together. No preferred option is thus proposed at this stage. 
 Who supports which option? 
 All professional organisations representing the various farming, breeding and food industry sectors are in favour of the status quo and resist new measures on cloning as they may trigger additional costs and administrative burden. Conversely, the European consumer organisations and other NGOs are in favour of a mandatory labelling of food products derived from the progeny (offspring and descendants) of clones and the suspension of the cloning technique in the EU. 
 C. Impacts of the preferred option 
 What are the benefits of the preferred option (if any, otherwise main ones)? 
 This option has a positive impact on animal welfare and creates a level playing field for all farmers and breeders in the Union. It is restricted to the technique, to clones and food obtained thereof. Its impact on Union FBOs and trade is limited because trade, if any, is likely to be insignificant as FBOs have no interest to market food from clones. The suspension of the technique would not stifle innovation and research as it would be temporary and limited in scope. It thus signals that research outside this policy can be pursued. Traditional breeding techniques use clones to produce offspring. Hence the suspension of the use of reproductive material of clones could jeopardize the competitiveness of the Union's farming sector as it would deprive it of competitive genetic material. This option has a positive impact on consumers: their concerns about animal welfare will be addressed as no cloning would take place in the Union and no food from clones marketed in the Union. 
 What are the costs of the preferred option (if any, otherwise main ones)? 
 The impact of the preferred option on business is negligible as trade in animal clones and food derived thereof is quasi non-existent and food business operators have no commercial interest in marketing clones or food from clones. 
 How will businesses, SMEs and micro-enterprises be affected? 
 The freedom to conduct business might be restricted but this would be justified for the purpose of protecting animal health and welfare and the suspension would be stopped as soon as the technology has evolved.  The Directives will not have an impact on SMEs and micro-enterprises 
 Will there be significant impacts on national budgets and administrations? 
 There would be no additional costs for Member States' control authorities as official controls are already in place on animals and their reproductive material, as well as on food labelling in general. 
 Will there be other significant impacts? 
 The preferred option could have indirect long term effects on the allocation of innovation investments. Organisations looking to invest in the development of cloning in general may be more inclined to place their investments elsewhere. Therefore we need to continue to encourage cloning for research. 
 D. Follow up 
 When will the policy be reviewed?   
 Both proposals trigger a review process By 5 years after the date of transposition of this Directive when Member States will have to report to the Commission on the experience gained by them on the application of the Directives. 

1.         
Procedural issues and consultation of interested
parties
1.1.             
Introduction

Cloning is a relatively new reproduction technique
which allows the asexual reproduction of an individual farm animal that has
shown good productivity. Cloning does not involve any genetic modification. In
fact, the clone is a near exact genetic copy of the original animal (the donor)
and should have the same high quality reproductive material (semen, ova or
embryos) as that of the donor. Although cloning does not improve the
animal's performance, breeders may consider cloning beneficial in order to increase
the output of reproductive material of a particularly valuable animal. 
Clones for food production are used to
produce reproductive material. As shown in the schema below, the reproductive
material of the clone enables the production of progeny (composed of offspring
and then of descendants). This progeny is produced via traditional breeding
techniques (not involving cloning). It is mostly destined for direct use in the
food chain although elite animals may be retained for breeding purposes. 
Clones are not produced
to obtain meat or milk for the food chain. This may however happen for meat, at
the end of the breeding life of the clone or when the clone obtained is less
efficient than originally foreseen and therefore no longer kept for breeding
purposes. The process of cloning is further detailed in Annex XIII (Paragraph
1).
       
                                
As cloning is a novel reproduction technique and as food from clones is susceptible to
enter the food chain, food from clones is presently subject to a pre-market
approval under the existing Novel Food Regulation[2].
The inter-institutional discussions on a proposal streamlining this approval
process reached a stalemate on issues related to cloning (such as the use of
the technique in the EU, the use of reproductive material of clones, of their
food, the traceability of progeny of clones and of their food). In spite of the
Commission’s report of October 2010, which suggested adopting specific measures
on cloning[3], no agreement could be reached and the Conciliation
ended in March 2011. This led to the request to the Commission[4]
to prepare a separate legislative proposal on all aspects of cloning for food
production based on a detailed impact assessment.
This
impact assessment therefore covers the five species susceptible to be cloned (i.e.
bovine, porcine, caprine, ovine and equine) and used for food production. Cloning of animals for research purposes, for producing medicinal
products or medicinal devices, for preserving rare breeds or endangered species
or for sport purposes is excluded from this policy initiative. A Glossary of
technical terms is to be found in Annex I. 

1.2.      
Organisation and timing

The
public consultation and collection of expertise
took place between end 2011 and end 2012. 

1.2.1. Member States

Member States
were consulted in the meetings of Standing Committee for the Food Chain and
Animal Health between February and July 2012 to clarify whether cloning takes
place and if so to what extent, and were subsequently invited to respond to a
specific questionnaire on these issues in March 2012. All 27 Member States
responded with Germany authorities clarifying their final position in May 2013.

In response to the questionnaire on the use
of cloning on their territory, to know whether clones are produced for food
production or imported and if so to what extent, all Member States confirmed
that cloning for food production does not take place on their territory. Most
of them specified that Directive 98/58/EC[5] (see section
2.6.1) is transposed into national animal welfare law. Only Denmark refers
explicitly to cloning which is banned on their territory. Germany who reported
in the past the existence of cloned bulls for selling their reproductive
material outside the EU confirmed in writing in May 2013 the absence of any
such clones on their territory. France reported cloning of horses but only for
sport purposes. The positions of Member States are summarised in Annex III
(paragraph 1). 

1.2.2.
Stakeholders and third countries[6]

Multi stakeholders meetings took place via the Advisory Group of the Food Chain (Annex II) with 22
organisations representing all concerned stakeholders (farmers and breeders,
meat and milk industry, food industry, retail industry, consumers and animal
welfare) on their position on possible action regarding the use of the cloning
technique in the EU and the appropriateness to label food from clones and of
their progeny so as to offer consumer choice.
Five technical bilateral meetings were held
with specific industry organisations on technical issues linked to breeding for
food production to understand the baseline scenario regarding traceability of
animals and of meat and milk. The minutes of the meetings are to be found in (Annex
II). 
15 third
countries with major trade (in meat, milk products
and reproductive materials) with the EU were also consulted via a specific
questionnaire sent in March 2012.  13 countries responded to the questionnaire
and one (New Zealand) sent instead a letter expressing their position. China
and Chile did not reply to the questionnaire. 
Based on the responses received to the
questionnaire on cloning activities to understand whether traceability systems
are in place for clones, their progeny and food, the responses received can be
summarised as follows: cloning for food production takes place in USA, Canada,
Argentina, Brazil and Australia.  In Canada the situation on cloning is similar
to that in the Union, i.e. food produced from food is considered novel and
requires pre-market approval. In the other countries, clones, their progeny and
reproductive material are subject to the same regulation as conventional
animals regarding the food safety, animal health and welfare. Clones are
registered by private companies (USA, Canada and Brazil)[7]
but Argentina and Australia report that clones are not registered. The number
and activities of cloning companies on their territory are not known by any of
the authorities. The positions of third countries are summarised in Annex III (Paragraph
2). 

1.2.3.
Responses to the public consultation “IPM consultation” & position papers

The public consultation was launched
in March 2012 via the Interactive Policy Making (the so called "IPM
consultation") for 16 weeks with reminders sent during this period via
the Enterprise Europe Network, on DG Health and Consumers website and via the
e-news network reaching approximately 6000 subscribers: 360 replies were
received among which 34 from professional organisations, 34 from
non-governmental organisations, 10 from Member States, one third country and
230 from individuals.  
Almost all[8] professional
organisations representing farmers, breeders, food industry and retail, when
asked about policy change on any of the issues of cloning indicated their favourable
position towards the status quo (no legislation on cloning, maintaining food
from clones under the Novel Food Regulation, no measures on food from progeny
of clones, no labelling). The additional position papers received from industry
(farmers, breeding sector and food industry) confirmed that the current
situation represents for them the best scenario. 
Conversely consumer organizations, animal
welfare associations and individuals, expressed themselves against the use of
cloning technique and the placing of the food from clones and their progeny on
the EU market. Finally, EU citizens participating in
the "IPM consultation"
emphasised that if food products originating from
clones and their progeny would be available on the EU market, they would want
to be able to make informed choices.
The responses to the IPM consultations are
summarised in Annex IV. The position papers of specific stakeholders are summarised
in Annex III (Paragraph 3). 

1.2.4.
Results of Eurobarometer of 2008 and 2010              

To understand the consumers’ position, a specific Eurobarometer of 2008 on cloning[9],
which surveyed 25000 randomly selected citizens in EU 27 and the 2010 Eurobarometer
on biotechnology of were used.
The Eurobarometer of 2008 on cloning showed
that around 80% of the interviewees agreed that there could be ethical grounds
for rejecting animal cloning and around 70% that animal cloning would risk
treating animals as commodities rather than creatures with feelings. Concerning
animal welfare issues linked to the use of cloning technique, 41% agreed that
it would cause animal unnecessary pain, suffering and distress and 42%
disagreed. In the Eurobarometer on biotechnology of 2010 EU citizens expressed
strong reservations about the use of animal cloning in food production. More
information on the responses is available in Section 2.2. (concerns of EU
citizens).

1.2.5.
Impact Assessment Steering Group (IASG)

The Impact Assessment Steering Group
(IASG) was set up in November 2011 with 11 Directorate-Generals as well as
EFSA: DG AGRI, ENV, TRADE, MARKT, RTD, JUST, ENTR, TAXUD, JRC, SG and LS. The
Group was consulted frequently. It agreed on the Roadmap in February 2012[10]
and dealt with the work carried out by the contractor, the IPM public
consultation, the consultation process with Member States and third
countries as well as the elaboration of this impact assessment report. 

1.2.6.
External expertise

The European Food Safety Authority
(EFSA) delivered an opinion in 2008 on the food safety, animal health, animal
welfare and environmental implications of clones, of their progeny and of the
products obtained from those animals followed by three statements in 2009, 2010
and 2012[11]. Based on the available
data EFSA confirmed the welfare problems related to the health of surrogate
mothers (carrying the clones) and clones themselves. Regarding food safety,
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. 
The specific report on cloning by the European
Group on Ethics in Science and New Technologies (EGE) of 2008[12]
was also used as source of expertise. The EGE expressed doubts on the ethical
justification on animal cloning for food production purposes, "considering
the current level of suffering and health problems of surrogate dams and animal
clones". EGE also concluded that it did "not see convincing arguments
to justify the production of food from clones and their offspring". 
In December 2012 a study[13]
by ICF-GHK was finalised concerning mainly the feasibility and costs of the
possible measures on animal cloning (summary in Annex V). 

1.3.                 
Opinion of the IAB

The IA report was
submitted to the IA board on 19. June 2013 and was formally presented on 17
July 2013. Following this meeting the board issued a positive opinion on 19
July 2013. The opinion suggested clarifying a number of points, which have been
addressed in the following manner:
1) Explain better
the uncertainty in interpreting Directive 98/58/EC as regards the use of the
cloning technique, its potential circumvention and the likelihood of unilateral
national measures and explain better why the existing pre-market approval would
still be considered fit for purpose for food from bovine and porcine clones. 
These issues have
all been addressed in section 2.3. "risk of diverging national laws on
cloning" and section 2.6.1. (b) "Novel Food Regulation". 
2) Explain why
measures to improve consumer awareness or upgrade/revise existing voluntary
(organic) label schemes have not been considered, give further insights into
consumers views clarify whether there is any evidence of undermined consumer
confidence because of absence of information on cloning, and to what extent
consumers are ready to pay higher prices, and why food business operators have
not developed voluntary labelling schemes. 
This explanation
has been added in section 2.2. on "concerns of EU citizens" and in  section
2.4 "the underlying drivers".
3) Present and
asses the  provisions on "mandatory" and "voluntary"
labelling versus "offspring" and "descendants" separately
and clarify the proportionality of option 2 and explain difference between
status quo and labelling food from clones/suspension of the cloning technique. 
This has been done
in section 5.2.1. "description of option 2" and in section 4.1. "Policy
options". In addition, sections 5.3. , 6.1., 6.2. and 6.3. present and
assess the options distinguishing between "offspring",
"descendants", "voluntary", "mandatory".
 4)Provide (as
appropriate) a more conclusive assessment of competitiveness impacts, clearly
differentiating between the impact on EU farmers, importers of food and the
food chain industry operators, clarify readiness of third countries to put in
place the traceability systems. These requests have been dealt with in section 5.3.3.(b)
and (c) and  overview tables (numbers 4 and 5) has been inserted in Annex IX. 
5) Section 5.1 on
the pre-market approval of food from clones and section 5.3.2. (a) on the
labelling of food from clones explain why the related costs would be marginal.
Regarding food from offspring and descendants, section 5.3.2. (b) explains the
costs of traceability and labelling.
6) Identify which Member States will be impacted most and explain
how the 2 % increase in the beef sector has been calculated. This has been
integrated in Annex IX. 
7) Clarify why
national authorities / EU budged are not expected to bear additional costs: The
clarification has been added to section 5.5. "Impacts on control".  
8) Give the key
results in a comprehensive overview table:  Table 9 has been added in Section
6. In view of the many possible options, in particular on labelling, this table
9 is a summary of the more elaborate overview which is to be found in Annex XII.

9) Mention
monitoring indicators corresponding to the data collection and respective
objectives: this data has been added in section 7.
10) Complete Summary
and Executive Summary sheet with most relevant information: this   has been
done. 

2.         
Problem definition

As indicated under 1.2.6. above 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.

2.1.                 
Animal welfare concerns linked to the use
of the cloning technique

In the EFSA's
opinion on animal cloning of 2008 and subsequent statements until 2012 it is highlighted
that issues of welfare and health of animals for the surrogate dams (carrying
the clones) and the clones themselves are arising. This evaluation is however based
on limited data and related primarily to bovine and porcine species. In
particular: 
a) For
bovine and porcine species EFSA noted that surrogate dams suffer in
particular from placenta dysfunctions contributing to increased levels of
miscarriages. This contributes, amongst others, to the low efficiency of the
technique (6-15 % for bovine and about 6 % for porcine species) and the need
implant embryo clones[14] into several dams to
obtain but one clone. In addition, clone abnormalities and unusually large offspring
result in difficult births and neonatal death. After weaning no significant
differences from conventional animals are noted.
b) for other
species (ovine, caprine and equine), EFSA stated that there was not enough
data available to complete its assessment on animal welfare aspects.
c) As regards offspring and descendants of
clones, EFSA concluded that no animal health or welfare problems affect
offspring and descendants of clones, as compared to conventionally bred
animals, for all species as they are produced, via traditional reproduction
techniques.

2.2.                 
Concerns of EU citizens

The vast
majority (above 80 %) of EU citizens interviewed in the Eurobarometer survey
had a broadly negative perception of the use of cloning technique for food
production[15]. This was primarily due
to welfare and ethical concerns. EU citizens also
indicated that if food products originating from clones and their progeny would
be available on the EU market, they would want to be able to make informed
choices. Half of the interviewees also considered – incorrectly- that animal
cloning involves genetic modification. 
This is highlighted by both the 2008 and 2010
Eurobarometer and the IPM consultation launched for this impact assessment (see
chapter 1.2.4. above). 
This strong
negative perception of cloning appears to be at least partly the result of:
-         
the unfounded assumption that cloning of food
producing animals poses a risk to food safety and human health; 
-         
the false idea that this cloning involves
genetic modification;
-         
general scepticism towards new technologies in
biosciences;
-         
fear that negative effects of cloning manifest
themselves only later.

2.3.                 
Risk of diverging national laws on
cloning

The growing
concern of public opinion in particular about the animal health and welfare
issues associated with the use of cloning for food production could push Member
States to take measures unilaterally on issues linked to the use of the cloning
technique, the use of clones (reproductive material and/or food) and to the labelling
of food to inform consumers. 
Member States
may ban explicitly the use of cloning technique on their territory in
accordance with provisions of Directive 98/58/EC on animal welfare on all
species or only on some of them. Directive 98/58/EC forbids the use of
"breeding procedures which cause unnecessary pain" but does not
explicitly forbid the cloning technique. Denmark adopted in 2005[16]
a national legislation which forbids the use of the technique on the national
territory but does not regulate the intra-Union trade and the imports of
animals, their reproductive material or food. It therefore has no impact on the
functioning of the internal market. However, it is not certain that other
Member States, when taking national measures, in the absence of EU initiatives
would take a similar line as Denmark. They may interpret the provision of the
Directive in a way that the use of clones, whether produced nationally or
imported, and their products (reproductive material and food) are also
forbidden on their territory.
There is no
information about the circumventing of the de-facto ban on the use of cloning
technique as there is no legal requirement for EU operators to register any
information related to the cloning status of their animals or informing the
competent authorities when buying
a clone or its reproductive material (same requirements as for conventionally
bred animals).   
During the
Conciliation referred to in paragraph 1.1.above, Member States expressed their
willingness to see measures on cloning at EU level but did not specify which
type of national measures they would adopt in the absence of EU initiative. Taking into consideration the
outcome of the inter institutional debate on food from clones, it appears that
the absence of comprehensive EU measures on cloning could present some
challenges to the good functioning of the concerned markets as divergent
national legislations could be adopted by Member States. However, since the end
of the conciliation (as referred to in paragraph 1.1. above), only Austria
highlighted in writing the need to address cloning at EU level to avoid
adoption of diverging national laws without specifying to which aspects such
laws would refer to. 

2.4.                 
The underlying drivers

They are three-fold and can be summarised
as follows: 
- The animal health and welfare problems
identified by EFSA are due to the use of the cloning technique and its current
level of development. EFSA clearly indicates that the negative effects have
been observed in other assisted reproductive techniques (not involving cloning)
but at much lower frequencies[17]. In the latest update of
2012, EFSA concludes[18]
that the scientific knowledge available has increased but that only limited
progress has been achieved to diminish or solve of the problems identified as
the efficiency of cloning is still low compared to other techniques; in
particular, EFSA mentions that to overcome the relative low cloning efficiency,
researchers continue to amend cloning procedures, with however limited
improvements shown by some researchers. 
- The consumer's attitude towards
the cloning has been summarised as follows in the 2008 Eurobarometer study
(page 11 of the summary):  
It is thus a
general negative perception of this reproduction technique generated by
different motives.
This general
negative perception give rise to a desire to recognize the food derived from
clones and their progeny as clearly shown by the survey's results.
The results
show that consumers are reluctant to buy products of cloning origin. There is,
however, no evidence that buying behaviour for food of animal origin would in
practice be influenced by the knowledge on the reproduction technique used.
It is not clear
to what extent consumers are ready to pay a premium for information on the food
from clones and their progeny. Respective questions were not asked in the
context of the various consultations held[19] due to the known
discrepancy between the consumers' replies to such questions and their actual
purchasing behaviour. The situation is thus not comparable to that of the BSE
crisis[20].
- The request
to produce a dedicated policy on cloning is due to the outcome of the
discussions on the Novel Food legislative proposal (see Section 1.1.), where it
appeared necessary to clarify and address all different aspects related to
cloning going beyond the food aspects. In this context, the Member States
already requested the Commission to prepare a proposal on all aspects of
cloning, based on an impact assessment. As the conciliation did not conclude,
the final positions of Member States and Parliament remain unclear.  More
specifically Member States requested by unanimity a pre-market approval for
food from offspring in first reading but in the subsequent discussions it
appeared that some Member States were in favour of labelling and others were
totally opposed. The European Parliament[21] requested a
ban of the technique, of meat and dairy products of clones and of their
offspring as well as of their reproductive material, and then, in second
reading, a total ban of any food from clones and descendants[22].
More recently in the context of the discussions of electronic identification of
bovine[23], the European Parliament
requested mandatory labelling of fresh meat of offspring of clones pending the
presentation by the Commission of the specific proposal on cloning. 

2.5.                 
Who is affected, in what ways, and to
what extent?

The range of
actors that could be potentially affected by any measure taken covering the
three aspects of cloning (technique of cloning, live animals, their
reproductive material and their food) is very wide and include the following : 
- The breeders,
which produce and market the reproductive materials (semen, embryo and ova)
to improve the genetic performances of farm animals for the meat and milk
production or other relevant traits. The sector is composed of cooperative of
farmers or specific companies specialised in livestock genetics. They may be
affected in so far as they presently import reproductive material from third
countries some of which could derive from clones. They import limited numbers
of live animals but these could also be clones or offspring or descendants of
clones, in which case they would also be impacted. 
 - The farmers
(or livestock sector), which raise animals for food production,
which accounts for a large part of the EU agricultural output (41% of in value
terms, representing 1.2% of the European Union’s GDP); they may be impacted
when they buy reproductive material of clones to raise offspring and
subsequently descendants on the EU territory of food production. 
 -The EU
food industry at the different stages of the food chain (from
slaughterhouses to distribution and retail) when using food from clones,
offspring or descendants of clones raised in the EU or importing such food from
third countries. SME's play a key role in the EU food sector on every stage of
the supply chain, representing nearly 452 billion € of turnover (Annex X).
-Third
country operators who trade live animals, reproductive material, or food
with the EU would also be affected. This would be in particular the case of
cloning companies and breeders who may produce reproductive materials from
clones (or from offspring or descendants of clones) and export it to the EU; it
may also affect food operators in third countries who export meat, milk or the
derived products to the EU and which could derive from clones or progeny of
clones
- EU consumers as purchasers of the
food products available on EU the market.

2.6.                 
Baseline scenario
2.6.1.
EU legal framework
a) Legislation
on animal welfare

The EU
Directive 98/58/EC on the protection of animals kept for farming purposes[24]
does not refer explicitly to cloning but requires Member States to act at
national level to avoid unnecessary pain, suffering or injury in the context of
raising farm animals and mentions that such obligation also applies in the use
of reproduction techniques. In so far as cloning causes unnecessary pain,
suffering or injury, as highlighted by EFSA it cannot be used for food
production on the EU territory pursuant to this Directive. The feasibility and the appropriateness of introducing specific
welfare indicators to ensure uniform application of EU legislation is being
studied under the Welfare Strategy[25].

b)  Novel Food Regulation

The Novel Food
Regulation[26] covers, to date, the
food derived from cloned animals, which are subject to a pre-market approval
and a risk assessment by a national competent authority. If an authorisation
would be granted mandatory labelling could be requested on a case by case
basis. The cloned animals and their food would need to be identified as
"clones" or "derived from clones". To date this identification
system dedicated to cloned animals is not in place. Moreover no request for
authorisation has ever been made up to now (see further details in Annex V). 

c)  Legislation
on identification of animals 

The EU legislation on identification of animals is a prerequisite
for the traceability of animals in case of disease outbreaks.
Animal identification systems are established with Regulation (EC) 1760/2000[27], Council Directive
2008/71/EC[28], Council Regulation (EC) 21/2004[29] and
Commission Regulation (EC) No 504/2008. These measures provide for mandatory
identification devices or marks, passports and registers. All equine animals
are identified individually[30]
for their life time and registered in databases. Bovine, caprine, and ovine
species[31]
are in principle identified individually but are subject to some exceptions
granted to Member States. Porcine animals are not identified individually; they
are identified in "batches" (i.e. same registration number for each
pig belonging to the batch). 
In addition, all holdings have to record the individual animals (or
the batches, in the case of pigs) as well as their movements in their own
registers. 
No system requires information on the reproduction methods the
animals were produced with. It is thus nowhere specified whether the animal is
or not a clone or a progeny of clone.  
All five species can only be moved between Member States or imported
into the EU when accompanied by a "health certificate" delivered by
an official veterinarian of the Member State or the third country of dispatch.
Further details are given in Annex VI.

d)  Legislation
on identification of reproductive material
and traceability of the reproductive material to an individual animal

The EU legislation requires - for both imported and EU produced
reproductive material- the individual identification of the donor animal. The
precise identification of the animal needs to be indicated on the straws, or ampoules,
or packaging, or  the accompanying "health certificate".  
There is no requirement to specify that the donor is or not a clone
or a progeny of clone. 
Further details are given in Annex VI.

e)
Legislation on traceability of animals

Traceability of animals is the ability to track an animal or a group
of animals from one point in the supply chain to another, either backwards or
forwards.EU legislation imposes traceability systems for the purposes of animal
health to provide the information required to implement control measures
against disease. They allow that animals can be traced from holding of birth to
death/slaughter. 
Further details are given in Annex VI. 

f)
Legislation on traceability of food from animals

Traceability of food is imposed on all food business operators
(FBOs) established in the EU by the General Food law[32].
FBOs must be able for any food and through all stages of production,
processing, and distribution, to identify the immediate supplier of the product
in question as well as the subsequent recipient. FBOs organise their production
by batches (groups of products with homogeneous characteristics) so as to be
able to identify the batches which contain the food to be withdrawn in case of
fraud or food safety issue. 
This system does not ensure that food (such as a piece of meat) can
be traced to an individual animal.
The compulsory labelling system established with Regulation
1760/2000 obliges food business operators to label the
beef at all stages of the marketing process and thus to establish the
underlying identification and traceability system to allow them to provide the
information required, i.e. country where the animal was slaughtered, the license
number of the slaughterhouse, the country where cutting was performed, the license
number of the cutting plant, the country where the animals were born, the
country where the animals were fattened/bred. Imported meat for which not all
compulsory information is available is labelled "Origin: non-EC",
followed by the name of the third country in which it was slaughtered.
Further details are given in Annex VI. 

    g) Legislation on zootechnics and
voluntary guidelines

To be entered
in a herd-book of the same breed, purebred animals of all five species and
their genetic material must comply with EU requirements (e.g. parents and grant
parents of that breed must be registered in the same herd book and mentioned on
the certificate)[33]. Compliance is attested
in specific "zootechnical certificates". 
There is no EU
requirement to register clones specifically in herd books. However, for a
particular dairy cattle breed, guidelines have been established on a voluntary
basis by the World Holstein Friesian Federation (WHFF)[34]
on how to register clones, the donor animal and the required ancestors. It is
not known how far this is implemented by breeders, whether it exists for other
breeds and how much attention EU breeders and farmers give to this information.

Further details
are given in Annex XIII (Paragraph 5).

2.6.2.
Baseline scenario regarding the farming, breeding and food sectors

The EU
livestock production accounts for 41% of agricultural
output in value terms, representing 1.2% of the European Union’s GDP. In value
terms, beef and milk represent over 50% of total output, with sheep meat
representing over 20%[35]. 
Regarding
number of actors across the meat and dairy supply
chain, there are almost 8 million farmers/producers, around 80.000 processors
and the same amount of wholesalers and close to 700.000 food and specialist
meat and dairy retailers across Europe[36].
The EU food sector represents[37] a total turn-over of 1,017 Billion €
and approximately 287,000 companies employing 4.25 million people in the EU.
Around 98 % companies are SMEs which represent around 49 % of total turn-over
and 63% of employment in the sector. It is the largest manufacturing sector in
terms of turnover, value added and employment. It contributes for around 15 %
of EU gross value added of manufacturing sector. 
SMEs play a key role in the EU food sector, at every stage of the supply chain. They represent nearly EUR 452
billion of turn-over, with EUR 93 billion of value added and employ about 2.7
million people in 271,000 enterprises which are 99.1% of total Food & Drink
companies, and 48.7% of total turnover[38].
The meat consumption is expected to remain high.  On a per
capita basis, EU meat consumption in 2022, at 82.6 kg, would be at
approximately the same level as it was in 2009. Pork is expected to remain the
preferred meat in the EU with 40.8 kg/capita consumption in 2022, compared to
24.1 kg for poultry, 15.7 kg for beef/veal and less than 2.0 kg for sheep and
goat meat. Meat demand in Northern America and Europe would remain globally
stable by 2050[39]  but still remain
highest in the world by 2050 at around 89 kg per inhabitant (against an
estimated 83 kg in 2010).
Regarding the economic performance, gross profit margins are
generally not high in the livestock sector but they are positive. However,
measured by economic profit and thus also taking into account estimates of the
unpaid family factors is negative in most cases, which suggests that resources
are not being optimally allocated[40]. Thus, across the food
chain, efficiency gains through technological or process innovation are being
pursued, which is also a factor leading to concentration in the sector. 
The structure
of livestock breeding in Europe is primarily composed of elite breeders at
the top (mostly organised in cooperatives owned by farmers, which are often
SMEs) who supply commercial herds in charge of meat and milk production.   
Cloning for
food production is not taking place in the EU as
reported by Member States (see Section 1.2.1. above) and there is little
prospect of commercial cloning activity in the period to 2020, or at least to
any significant scale.. 
The actual
impact of cloning on farm-level economics can be estimated as providing
an annual increase in milk yields of 300kg (estimate for a period of ten years)[41].
For comparison, it is necessary to know that current high end producers are at
an EU average of 7000 kg per annum which would mean cloning could provide for
an additional increase of 4%. This has to be put into comparison to the current
EU dairy market: over the last 3 years, milk deliveries remained relatively
stable, with only small variations while forecast for 2020 predict EU-27 total
milk production to exceed the 2009 level by about 3%[42].
Further details
are given in Annexes VII and VIII. 

2.6.3. International dimension
a) Legal framework

For live
animals, animal products (including reproductive materials and food), the following multilateral agreements of the World Trade
Organization (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 on the objective and the
drafting of the envisaged legislation.
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). Departures from this general rule could be justified under
Article XX of GATT (General Exceptions) which allows for measures taken on
grounds of "public morals", which could be interpreted as including animal
welfare or for measures taken on grounds of the protection of life and health
of human or animal 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 manner. In
addition to the GATT, the envisaged legislation would be subject to either the
SPS Agreement or the TBT Agreement, depending on its objective and design.
The SPS
Agreement applies to measures taken with the objective to protect human, animal
or plant health from diseases carried through food, feed, animals, plants or
pests. A measure that conforms to international standards is presumed to be in
compliance of the SPS Agreement, but there are no international standards on
cloning. The SPS Agreement requires measures within its scope to be based on
science, proportionate and non-discriminatory.
To the extent the legislation lays down product
characteristics or related processing methods, labelling, packaging or other
requirements, and these requirements do not relate to SPS objectives, the
TBT Agreement would apply. The TBT Agreement requires measures to be
non-discriminatory and not more trade-restrictive than required to achieve a
legitimate objective. Measures should not create unnecessary obstacles to
international trade.

b) Cloning
activity in third countries

As commercial
cloning for food production is presently taking place in third countries and as
the EU imports animals, reproductive material and food, which could potentially
be clones or derive from clones, the third country trade aspect of this policy
must be taken into account. Based on the replies to the questionnaire (see
Section 1.2. above), third countries' authorities do not have any information
about the number of clones and the specific activities carried out by cloning
companies on their territory, or about the amount of food products of clones or
progeny of clones. Based on the consultant's study and information received
from US companies and stakeholders (Annex II), cloning takes place primarily
for bovine (for food production) and equine (for elite sports horses). It is
also carried out for porcine (for food production) but to a much lesser extent.
It is presently not known whether it is used commercially for ovine species and
should have just started for caprine in the US. The possible reasons for this
relatively limited development could be due to the low efficiency of the
technique as highlighted by EFSA and the related high costs, placing prices of
clones above the prices of high quality animals. This could also explain why
cloning could represent  a higher commercial interest in the case of more
expensive animals such as bovine for breeding purposes or horses for sport
purposes. 
The overview of
commercial cloning is summarised below: 
Overview of
commercial cloning in third countries 
Bovine
animals: 
the most developed. Applied to cattle in the US, Canada, Argentina and
Australia[43] It may also be
undertaken in Brazil, New Zealand, Chile, China and Uruguay based on the
presence of cattle cloning companies in these countries. 
Milk
and meat
from the offspring or descendants of cloned bovine animals have entered the
food chain in the US and may have done so in Argentina; these are the products
most likely to continue to enter human food chains in the near future. The
Swiss government says that ‘several hundred’ second or third generation
descendants of clones are in Switzerland (of a total 1.5 million head of
cattle);[44] 
Porcine
animals:
consultations with the US cloning industry suggests that there is some
commercial cloning for pigs in that country and that it is becoming more
common. It may also be undertaken in New Zealand and China based on the
presence of pig cloning companies in these countries.
Ovine
and caprine animals: consultations with industry stakeholders
in the EU of third country Competent Authorities indicate that commercial
cloning of ovine or caprine animals outside the EU is uncommon.  Some
commercial cloning of these animals has started in the US, but at very small
scale. Equine animals: consultations of third country Competent Authorities
indicate that there is no livestock cloning activity currently being conducted
for equine animals. Sport cloning is undertaken in North and South America and
Brazil and South Korea..[45]
Source GHK study
page 26 

c) EU imports of live animals, reproductive material and food of
animal origin 

The EU imports
live animals (LA), reproductive material (RM) and animal products, in many
cases from one or more of the five countries (USA, Canada, Argentina, Brazil,
Australia) where commercial cloning is taking place. The
extent to which these imports are related to clones, to the reproductive
material of clones or their progeny is presently unknown as there is no
requirement (neither under EU law; nor in third countries) to identify them as
such. 
As shown in the
table 1 below, the share of imports of live animals and
of reproductive material compared to EU production or livestock is very low
(respectively <0.01% of EU livestock and 2.5 % of EU use of reproductive
material). The share of EU
imports of meat and milk products is also low except for ovine /caprine and
equine meat, where it ranges between 20 % and 50 % of EU production
respectively. 
For these
species, however cloning is not taking place for food production or may have
started to a very limited extent.    
Table 1
Summary of EU imports from main exporting countries 
   || Species || Main exporting country || Amount || % of EU imports of livestock, use or production 
 Live animals || Bovine || Canada and New Zealand || Very low || <0,01 % of livestock 
 Pigs || Russian federation, Canada and USA || Very low || <0,01 % of livestock 
 Others || USA, Argentina, New Zealand and Chile || Very low || <0,1 % of livestock 
 Reproductive material   (semen) || Bovine || USA, Canada, New Zealand and Australia || Low at EU level  but medium to high in some MS || 2.5 % of use of semen in EU in average   and up to 20 % or more in certain MS * 
 Others || Canada, USA, Australia and New Zealand  || Not available || Not available 
 Reproductive material    (embryo) || Bovine || Canada and USA || Not available || Not available 
 Meat || Bovine || Argentina, Brazil and Uruguay (70 % of all imports), Australia, USA, New Zealand || Low || EU net importer (5 % of EU production) 
 Ovine || New Zealand (80 % of all imports) || High || EU net importer (23 % of EU production) 
 Caprine 
 Porcine || Chile, USA and Australia || Very low || EU self-sufficient (<0.1% of EU production) 
 Equine || Canada, Argentina, Mexico, Uruguay || High || EU net importer (50 % of EU production) 
 Fresh milk || Bovine Caprine Ovine || Croatia, Switzerland and Norway (99 % of all imports) || Very low  ||  0.01% of EU production 
 Cheese & butter || Bovine Caprine Ovine || Switzerland, New Zealand, USA, Australia and Norway || Low  ||  2 % of EU production 
Very low: <1%; low: 1% -
5%; medium: 6% -20% high: 21% -50%;
Sources: Eurostat External Trade Statistics
(COMEXT), Traces; * Source: Commission report on animal cloning for food
production–COM (2010) 585 and stakeholders in Advisory group meetings (minutes
in Annex II).
However, in
terms of value, as shown in table 2 below, out of a total value of 3.6 billion
€ of imports of food per year, imports of meat accounts for 80 %, of which the
highest share is composed of bovine meat (60 %) imported from countries where
cloning takes (notably USA, Argentina, Brazil). The share of ovine and caprine meat
in value of all meat imports is also relatively high (35 %) but as stated
above, cloning for these species is not developed for the time being. 
EU trade on
reproductive material takes primarily place with the USA and Canada. 
- Imports of
reproductive material account for a small percentage of total use in the EU (2.5%
on average[46]) but the breeding sector
considers access to this genetic material as essential to the continued
viability of the industry[47]. The majority of
imported reproductive material is from bovine (in value): for example in 2011,
the value of all imported reproductive material (all species) was of €48
million in 2011, originating at 93% from bovine.  The US and Canada are very
dominant in EU supply of reproductive material for all species (bovine at 98%,
porcine at 100%, ovine and caprine at 80 %, equine at 98%).
-The EU
exports bovine semen worth €25 million each year[48] of which
almost half to the US, Canada and Latin America.
Table 2 Import value in million € from 2010 to 2012
   || Species || 2010 || 2011 || 2012 
 Live animals || TOTAL Live animals || 193 || 120 || 185 
 Bovine || 0.91 || 1 || 0.62 
 Swine || 1 || 0.53 || 0.77 
 Sheep and goats  || 0.28 || 0.85 || 0.12 
 Equidae || 191 || 118 || 184 
 Meat || TOTAL Meat || 2731 || 3046 || 2847 
 Bovine || 1576 || 1702 || 1693 
 Porcine || 58 || 55 || 52 
 Ovine/caprine || 999 || 1195 || 1003 
 Equine || 98 || 94 || 99 
 RM* || TOTAL || 45 || 48 || 49 
 Milk &Milk products** || TOTAL || 644 || 688 || 722 
 TOTAL || 3612 || 3901 || 3802 
* Reproductive Material from
bovine         ** from bovine, caprine, ovine 
Source: Eurostat. Comext
-Extracted 7/06/2013

2.7.                 
Does the EU have the right to act
(subsidiarity)?
Right to
act (EU competence)

Article 13 TFEU
specifies that welfare requirements of animals shall be taken into account by
the Union and the Member States when formulating and implementing Union
policies. However, this Article in itself does not grant the EU a competence to
legislate on animal welfare.
Existing Union
legislation on both animal welfare and identification of farm animals and their
reproductive materials is based on Article 43 TFEU (Agriculture). Measures
regulating the use of the cloning technique would address the associated animal
health and welfare concerns, and would prevent the development of diverging
national legislation on this technique adopted to implement the general
principles laid down in Directive 98/58/EC on the protection of animals kept
for farming purposes and the consequent disruptions of the concerned
agricultural markets. They would therefore ensure legal certainty and a level
playing field for breeders and farmers and to ensure uniform conditions of
production for farmers.  Therefore, it may be possible to base certain measures
on Article 43 TFEU. 
As regards the
EU competence under Article 114 TFEU (Internal Market), this requires a risk of
divergence between national legislations as explained in paragraph 2.3 above.
Finally, EU
competence for certain measures could be drawn from Article 352 TFEU (Flexibility
Clause) under the conditions set out therein.

Necessity
of the EU to act (Subsidiarity)

Issues linked
to animal cloning relate to the identification and traceability of life animals
and of their reproductive material. As live animals, their reproductive
materials and derived food can be freely traded in the Internal Market the
issue needs to be addressed at Union level. Isolated national approaches could
lead to market distortion. 

Proportionality

The options
identified as feasible as a result of this impact assessment should be suitable
and necessary to achieve the objectives set out below and they should present
the best cost benefit ratio to resolve the issues at stake, as explained in the
comparison of options in chapter 6.2.

3.         
Objectives 
3.1.                 
General objective

To address concerns raised as regards cloning for farm purposes and
ensure uniform conditions for farmers in the EU and to protect consumer
interests as regard food from cloned animals.

3.2.                 
Specific objectives 

Objective 1:

To ensure
uniform conditions of production of farmers in the EU while protecting health
and welfare of farmed animals;
Objective 2:
To protect
consumer interests as regards food from cloned animals 
Objective 3:
To safeguard
the competitiveness of farmers, breeders and food businesses in the EU.

3.3.                 
Consistency with other EU policies and
horizontal objectives

The objectives
identified are in particular in line with: 
- the Europe 2020
Strategy in favour of a sustainable development based on innovation and
competitiveness of EU economy and agriculture; 
- the Common
Agricultural Policy objectives including in relation to the rearing of
animals for food production;
- the EU Food Law
defines the requirements applicable to all foods as regards food safety and
consumer information.
It also improves
coherence with other EU policies notably on:
- the Novel Food
Regulation, which as mentioned in 2.6.1.a. above, addresses only food from
clones; 
- the Animal welfare
strategy for the protection and welfare of animals for 2012-2015[49],
which  in addition to the Directive 98/58/EC (see 2.6.1 above), aims to further
improve the welfare of animals in the European Union;
-
the EU legislation on Food Information to Consumers[50]
which lays down labelling requirements applicable to all foods. 
Finally, it takes into consideration the impacts of this initiative
on the Charter of Fundamental Rights of the European Union especially as
regards the freedom to conduct a business (Article 16) and consumer protection
(Article 38) as further analysed in section 6.2.

4.         
Policy Options
4.1.                 
Policy options included in the analysis

In light of the
problems and objectives outlined above, 4 options were retained. They are
described below and are also summarised in Table 3 (below).
Option 1:
no policy change. The pre-market approval for
food from clones under the current Novel Food Regulation would be maintained.
Regarding cloning, Member States would continue to be entitled to act at
national level, in line with Directive 98/58/EC on animal welfare. 
Option 2:
Pre-market approval of food from clones, from offspring and descendants.
As regards food
from clones, this option differs from the status quo from a procedural point of
view only[51].  
The main
difference to option 1 is that it would enlarge the scope of the pre-market
approval from food of clones to food of offspring and descendants of clones.  Accordingly
this food would become subject to a scientific risk assessment by EFSA followed
by a decision of the Commission to authorise or not the food[52].

It has to be
stressed that EFSA has already confirmed the absence of a risk to food safety.  
However, it is
important to assess this policy option since this option had been put forward
by the co-legislators during the discussions between 2008 and 2011 on a reform
of the Novel Food Regulation. Moreover, EFSA could not establish the absence of
food safety concerns for the other species than porcine and bovine (ovine,
caprine, equine) in the absence of specific data. Therefore the pre-market
approval would be useful (i) to confirm the safety for the bovine and porcine
species; and (ii) to encourage the establishment of data for the other species
so as to be able confirm in a second stage their safety.
Option 3:
labelling of food from clones, offspring and descendants 
Sub-option 1:  labelling of food from clones
Sub-option 2:  labelling of food from offspring 
Sub-option 3: labelling of food from descendants
Under this
option food from clones, offspring and descendants would be labelled. The
labelling would apply incrementally to the various generations analysed in the
two sub-options or only to one of them according to the results of the
analysis.
In order to be
able to label this food, traceability systems would need to be in place for the
live animals (as regards previous generations of animals), reproductive
material and the food from the animal (as regards the individual animal which
was the source of the food).
Sub-option 4: voluntary labelling
Sub-option 5: mandatory labelling
Under this
option the possibility to introduce voluntary labelling (sub-option 4) or mandatory
labelling (sub-option 5) will be investigated as well as the different type of
food covered:  direct fresh food (fresh meat or fresh milk or both) or  all
types of food (fresh food and processed food such as sausages, cheese, etc.).
Overall, this
option differs from the status quo as it does not require a pre-market approval
and extends the labelling to food from offspring and descendants.  
Option 4:
temporary suspension of the technique and of imports of live clones, their
reproductive material and their food.  
Under this
option the use of the cloning technique would be suspended in the
EU until this reproduction technique has been developed further so that the welfare
issues are alleviated. As a consequence, no clones, reproductive material and
food from clones would be produced on the EU territory. 
To avoid circumvention
of the suspension of the technique in the EU and create uniform conditions of
production for breeders and farmers, imports of the "results"
of the use of the technique in third countries (live clones, their reproductive
material and their food) would be suspended as long as the technique is
suspended in the EU. As a result, no offspring of clones would be produced in
the EU. 
This option
differs from the status quo as it forbids explicitly cloning on a temporary
basis throughout the EU whereas the rules in place (i.e. Directive 98/58/EC)  require
Member States to act at national level in a more general manner (i.e. "to
avoid unnecessary pain, suffering or injury" (…) including in the
"context of the breeding technique"). 
In addition
this option includes explicitly the suspension of the use of the clones (i.e.
suspension of the import of reproductive material and food of clones). 
Table 3.
Summary of the description of options:
 Option || Description || Generation covered || Traceability to implement the option 
 No Policy change || - PMA (+ labelling of the food on a case by case basis) - Directive 98/58/EC (animal welfare) || Clones || - For PMA live clones + their food (in EU and third countries exporting to EU) ; - For animal welfare, none 
 Pre-market approval || PMA || Clones, Offspring and Descendants || Traceability of live clones, offspring and descendants, + reproductive material & food of clones  (in EU and third countries exporting to EU)   
 Labelling of food || Labelling of food – voluntary or mandatory (fresh meat or fresh milk or all type of food)   || Clones, Offspring, Descendants 
 Suspension || Suspension of : cloning technique in EU + imports of clones + reproductive material & food of clones || Clones   || Traceability of clones + their food + their reproductive material (in third countries) 
 

4.2.                 
Options discarded at an early stage

The preliminary
options below have been discarded after discussion in the IASG based on the
following criteria: i) the legal feasibility of the proposed options (in
light of TFEU, EU secondary legislation and WTO); ii) the technical
limitations. 
(i) A permanent ban of the cloning technique, clones and their use
(reproductive material and food) was discarded as
the underlying animal health and welfare concerns identified by EFSA are linked
to the present scientific and technological development of the cloning
technique. The latter may, however, mature and thereby alleviate partially or
fully the concerns: the prohibition linked to the use of the technique and of
the clones needs therefore to be temporary with a review clause.  A permanent
ban would be unjustified and disproportionate.
(ii) A permanent ban or temporary
suspension of food from offspring and descendants was discarded as in the
light of the EFSA opinion there is no scientific concern or food safety reason
to forbid - whether temporarily or permanently - market access for such food.
There is therefore no legal basis to act for this option. 
(iii) The option of setting up harmonised conditions of use of the cloning technique
for food production was discarded based on the EFSA opinion: under current
scientific knowledge, it is not possible to define any conditions of use of the
technique which would alleviate animal health and welfare concerns identified
by EFSA. It is therefore not possible to define technical parameters to this
end.
(iv) Measures to improve consumer awareness that would potentially alleviate the consumer concerns or to
upgrade voluntary labelling schemes have also been discarded for the following
reasons: 
a)      consumers who reject the technique for ethical reasons, would not
accept it more if the technique is explained better and in further detail;
b)      as long as the technique, even explained better, implies the
suffering of clones and surrogate mothers, the reticence of consumers would
remain unchanged;  
c)      informing consumers that offspring and descendants are produced with
traditional breeding techniques and that no particular welfare concerns can be
associated with this, could clarify the difference between clones and
offspring. It would however not alleviate the reticence of consumers towards
cloning in the absence of measures on clones and the cloning technique;  
d)     it is difficult to establish a link between cloning and benefits to
consumers. Clones are of interest in high productivity farms where
"elite" animals are already used. Links between cloning and positive
effects on consumers (such as lower prices or contribution to agricultural
landscape) may therefore be difficult to establish; 
e)      information campaigns on such issues could be carried out by the
food sector  and not necessarily by public authorities whether at national or EU
level;
(v) Upgrade of labelling schemes: existing specific
labelling schemes (whether organic or other similar quality labelling schemes)
do not exclude the production of food from offspring of animal clones. This is
because offspring is produced with traditional breeding techniques and does not
therefore deserve or require special treatment. Based
on the information available, no FBO has so far set up any voluntary labelling
scheme on the non-cloning origin of animals. In cases where FBO could guarantee
non-cloning origin of animals the food is obtained from specific breeds
produced exclusively locally (not cloned or obtained from reproductive material
of clones).  This is presumably because the other positive messages have a
better impact on consumer behaviour. If there would be an interest to bring out
products of non-cloning origin, it would have to be in combination with other
positive messages - such as organic, GM free, special consideration of welfare
of animals concerns etc. 

5.         
Analysis of Impacts 

The analysis
has been performed using data provided by the external contractor ICF-GHK and
gathered through other data sources available[53].
However, limited quantitative data have not allowed for a detailed quantitative
analysis.
 5.1. Option 1: No policy change 

5.1.1. Description of the
option 

Food from
clones would remain within the scope of the Novel
Food Regulation and subject to a pre-market approval (PMA) based on a food
safety assessment. As described in section 2.6.1. paragraph b), the FBO's need
to submit an authorisation application to the Member State's authority to
perform a scientific risk assessment and pay fees for this. In case of
objections by other Member States to the risk assessment, the file is sent to
the Commission who consults EFSA who performs a new risk assessment on the
basis of which the Commission adopts a Decision for authorisation or not. If an
authorisation were requested and then granted, clones would need to be traced. 
At present this traceability system does not exist. In addition, labelling (as “derived
from clones”) could be requested on a case by case basis.
Food from
offspring and from descendants would continue to be
marketed without any distinction as to the animals it is obtained from. This
food is not covered by this option, consumers would not be able to know if the
product they are purchasing is deriving from offspring and/or descendants
The use of
the cloning technique would continue to be
regulated by Directive 98/58/EC.  Where Member States fail to implement the
Directive in relation to cloning, the Commission could start infringement
procedures. If Member States would take measures specific to cloning to comply
with the relevant requirements of that Directive, such measures would not
necessarily be uniform and could apply, for example, to different species or
types of breeds, to the technique as such or also to the imports of lives
clones and their products. Different national approaches might disturb the
functioning of the concerned agricultural markets. 
As EFSA has
already identified animal health and welfare issues linked to the use of the
cloning technique, the future use of welfare indicators, which could be
developed in the context of the Animal Welfare Strategy (see section 2.6.1.,
paragraph a) above) would not affect the status of this issue. 

5.1.2.
Economic Impacts

Regarding
the pre-market of food from clones, the potential economic impact relates to food business operators
(FBOs) which would like to market food from clones in the EU. The FBO will have
to file an authorisation application to be submitted to the national competent
authority who would charge fees to FBOs[54]. Where a fee is in place, it ranges from EUR 830 to EUR 25 000 and
from EUR 900 to EUR 2 000 for a simplified procedure.
FBOs bear a
series of additional costs related to the preparation of the file and the
application procedure. In detail, the cost of filing an application under the
Novel Food Regulation has been estimated to be up to 400.000 €[55] when toxicological tests are required (see details in table 4
below). Where the file is referred to EFSA for an opinion, there is additional
EU budget needed to finance the costs borne by EFSA in processing applications,
evaluated around 83 000 € per application for Novel Food[56]. Under the current Novel Food Regulation, authorisations are
individual: each FBO who intends to put food from clones on the EU market would
require a pre-market approval for the products; subsequent operators who wish
to put similar products to those already authorised on the market would need to
get approval from their national authorities for "substantial
equivalence", which, if granted, would not imply a new application dossier
and risk assessment.
Table 4:  Costs linked to
applications dossiers for pre-market approval
 Cost || Action 
 from 20.000 € to 45.000 € || to set up an application file for risk assessment 
 around 300 000 € || only if toxicological tests are required 
 administrative fees from 800 to 25 000 € || for the risk assessment by Member State 
In addition to
above application costs, FBOs would be obliged to adapt their traceability
system to trace food from clones and could also be requested to label their
food. Farmers and breeders would need to trace the clones. The additional costs
are not significant:   
·        
in view of the rather limited number of animals
concerned and the likelihood that they would be processed apart and labelled
through a segregated food supply chain* (see Section 5.3.2. paragraph b)
below), the traceability cost of food from clones for all EU operators along the
food chain would be negligible[57] and the amount of food produced in this way limited; 
·        
costs for tracing clones by farmers and breeders
are also considered marginal (see Section 5.3.2.b paragraph b) below); 
·        
the average cost at company level for a small label
change has been estimated at €2,000-4,000; a full label redesign has been
estimated at €7,000-9,000 (or €9,000-13,000 in total). It should be noted that
most companies (~80%) redesign their label every three years as a normal part
of their business operation[58] (see section 5.3.2 paragraph c). 
European
associations[59] representing the food industry, the milk and meat sectors are in
favour of this option, i.e. maintain the principle of a pre-market approval for
food of clones only (see Annex III.3).
As regards
the "no policy change" on cloning and taking into consideration the very limited cloning activity in
the EU, the economic impact on production costs for EU breeders, farmers and on
third country trade is considered non-significant. This is mainly linked to the
low economic profitability of the cloning technique which has an efficiency
rate[60] according to EFSA (calculated as the number of live offspring as a
proportion of the number of transferred embryos) still in the range of 6-15%
for cattle and of 6% for pigs, albeit occasionally higher success rates were
reported. Farmers and breeders would be able to continue to import live clones
or their reproductive material from third countries where commercial cloning
takes place. 
Regarding
SMEs, the specific impact mainly arises from the costs
for having to recruit specialists not permanently available in FBOs themselves
to prepare the applications. Another issue, which could present particular
challenges for micro and small enterprises -including direct on-farm sales of
food of animal origin to the final consumer- stems from the rules on
traceability and labelling, where the lack of economies of scale (lowering the
cost per unit) may lead to higher relative costs for SMEs. 
As far as
third countries are concerned, in case their food industry would intend to put food from clones on
the EU market, exporters would need to file an application for authorisation to
EFSA. They would have to incur the same application costs of the EU business
operator as well as additional labelling and traceability costs. If no
authorisation is granted[61], food industry in third countries where cloning technique is used, would
have to either remove food of clones from their food chain or remove it from
the food exported to the EU. The clones would need to be identified and
registered as such if their food is to be authorised by the EU before being
exported. 
Apart from food from clones which needs to
be identified, no other impact under this option is expected on third
countries: they would continue to be able to export live animals (clones and
progeny), their reproductive material and their food.  

5.1.3.
Impacts on consumer protection

The impact of
the pre-market approval of food from clones on consumer protection
is considered positive: in case labelling is requested upon authorisation,
consumers would be able to identify the food derived from clones and to make
informed choices as to whether a food product contains or not products derived
from clones. More than 70% of the total respondents to the IPM public
consultations are in favour of a mandatory labelling of food not only from
clones, but also from offspring and descendants of clones. 
This approach
is also supported by the European consumer association (BEUC)[62]. In its comments
BEUC urges the Commission to set up: “a full compulsory traceability system
(which includes clones and their offspring)”. 
The retail
sector (Euro Commerce) confirms that they would sell the products according to
acceptance by consumers but "practical solutions" would need to be
found to ensure traceability (Annex III paragraph 3).   
However, this
option does not entirely respond to consumer expectations as information of
food from offspring and descendants would not be provided.

5.1.4.
Impacts on food prices and employment

In case the
authorisation of food from clones would impose labelling, some
price-effects could be expected due to the additional costs for ensuring
traceability of clones and food obtained thereof. However, as explained in
Section 5.3.2. paragraph c) below, the impact is expected to be low although it
is not possible to quantify it.. Moreover it is not possible to quantify the
effect on employment for lack of data.  
Regarding the
prices for food from offspring and descendants, they would remain unchanged,
as no system is set up to ensure the expected information is available to
consumers and therefore no impact on employment resulting from labelling and
traceability requirements is expected.

5.1.5.
Impact on Animal Welfare

Under this
option animal welfare problems are addressed by the Member States under the Directive
98/58/EC.  
 5.2. Option 2: Pre-market approval for food from clones, offspring and descendants 

5.2.1. Description of the
option 

Under this
option FBOs would have to file an application for authorisation to market food
derived from clones, offspring and descendants. Contrary to option 1, the
authorisation would be submitted directly to the Commission who consults EFSA
for an opinion, avoiding thereby that FBOs have first to go to Member States'
authorities for a first assessment. This streamlined centralised procedure was
already foreseen in the 2008 Novel Food proposal as described in Annex VI
paragraph 5.   In addition, under this option, the scientific assessment would
cover food from offspring and descendants, although not considered as being
"novel" (as derived from conventionally bred animals) and presenting
no safety issue as indicated by EFSA. 
This option would
be more efficient than option 1, by imposing a centralised authorisation system
based on a risk assessment.. Yet this option does not address directly the
specific objectives set out in Section 3.2. However, it has been considered
worthwhile analysing it as it was supported - for food from clones and
offspring(1st generation) - by unanimity by the Council in first
reading during the inter-institutional discussions on the Novel Food proposal
(referred to in paragraph 1.1. above). As the offspring and the following
generations present exactly the same characteristics[63], it is appropriate for sake of coherence and completeness that this
option also includes food from descendants of clones. This option could be considered
appropriate for food from clones because of their novelty aspect and because
this option provides a more efficient approval system than under option 1.  However,
as regards food from offspring and descendants this option is inappropriate in
the absence of any specific food safety issue as highlighted by EFSA.
Under this
option, an application for authorisation would need to be submitted by EU or
third country FBOs, and authorisations would be granted based on a risk
assessment. In order to do so an underlying traceability system would need to
be in place. At present this traceability system does not exist. The
implementation of this option implies that in the absence of authorisation, the
food could no longer be put on the EU market. 
This approach is also supported by the European consumer association
(BEUC)[64]. In its comments BEUC urges the Commission to set up: “a suitable risk assessment and authorisation procedure complemented
by a compulsory labelling system for food derived from clones and their
offspring, should the temporary suspension be lifted in the future”.
Conversely,
industry representatives[65] are against taking measures beyond food of clones, as there is no
food safety concern with food from offspring and descendants. They base
themselves mostly on the EFSA opinion of 2008 and subsequent statements.  
  

5.2.2.
Economic Impacts 

As regards
the EU, the expected economic impact of this option
touches overall the same aspects of the assessment performed for food from
clones under option 1. However the magnitude of the impact is considered more
important as this option covers a longer chain and entails additional impacts:
the offspring and descendants of one single animal increases exponentially by
thousands of animals per generation (see Annex XIII paragraph 2). 
The costs for
filing an application for pre-market authorisation are the same than those
detailed in section 5.1.2 except for the fees paid at national level which will
no longer exist. In the case of an individual authorisation as under current
Novel Food Regulation (option 1), agreement on substantial equivalence
for each FBO is required. In the case of a generic authorisation, a single FBO
would bear the costs of application for a given food while all other operators
would benefit from this authorisation.
All FBOs
–whatever the type of authorisation foreseen- would have to be able to identify
this food as stemming from offspring or descendants of clones to be able to
prove that it has been approved beforehand. The impact for traceability would
be high for the EU food industry as the number of animals concerned (offspring
and descendants) would be much extended (as compared to clones). 
FBOs would need
to adapt their traceability system to trace food from the respective animals. 
There would therefore be costs for (i) the traceability of food for all EU
operators along the food chain, which would be important in view of the very
high number of animals concerned; and for (ii) the identification and
registration of clones, of offspring and descendants (and of their reproductive
material). The cost of traceability of animals and of food are described in
further detail in Section 5.3.2. below.  
Under this
option, EFSA would have to perform a risk assessment on food from offspring and
descendants of clones not considered at risk for public health. There would in
addition be cost to be borne by the EU budget to cover the costs involved in
processing applications (estimated at 83000 € per application) for Novel Food[66]. 
Such assessment
is only appropriate when possible risks are identified. In the case of food
from clones, offspring and descendants of clones, EFSA did not consider them
different from other food. The only justification for an authorisation could be
applied to food from clones, as here the animal is produced with a
"novel" reproduction technique; for other food such pre-market
approval would be even less justified from a scientific point of view. 
SME's cannot be excluded from any of the PMA mentioned above. This option
has therefore potential to impact SME profit margins and thus growth in
particular as they do not benefit from efficient production systems and/or
economies of scale enjoyed by larger firms. Traceability of food could present
particular challenges for micro and small enterprises but there may be some
differences among Member States (see Annex X) 
As regards
third countries, the
PMA requirement for food from offspring or descendants would create major
difficulties for EU importers and their third country suppliers. EU importers
need to have the guarantee that either (i) imported food does not derive from
offspring or descendants, or (ii) imported food has been approved. Otherwise,
they would no longer be able to maintain these imports. As explained in Section
5.3.3. below, third country operators would need to identify the food and
therefore the animals concerned (clones, offspring and descendants of clones)
which is not the case at present. Imports could be reduced or halted because
third countries would be unwilling or unable to meet the requirements of the EU
legislation. This would have an impact on EU imports of meat, milk and other
food products accounting[67] today for around 1.7 billion € for beef, 1 billion € for sheep and
goat meat and 722  million € for milk products[68] and could lead to major trade disruptions.

5.2.3.
Impacts on consumer protection 

Under this
option, consumers would be reassured that the food is safe but still, it would
not allow consumers to identify food from clones, offspring or descendants and
make informed choices. For this to happen, mandatory labelling, as described in
Option 3 below, would need to be provided for.  

5.2.4.
Impact on prices and employment

There would be
a negative impact on food prices as the price of meat and milk and
derived products could increase to compensate for additional compliance costs
due to extended requirements. The negative impact on consumer markets (prices
and choice) would be even higher if the major import, such in beef, would
cease. It is however not possible to quantify the envisaged impact as no
data is available, nor is it possible to quantify the effect on employment.

5.2.5.
Impact on Animal Welfare 

Under this
option animal welfare problems are not addressed.  
 5.3. Option 3: labelling of food from clones, offspring and descendants 

5.3.1. Description of the option 

As set out
above (section 4.1), this option has two elements: the scope of the labelling, and
its modalities (obligatory or voluntary)
(i) In terms
of scope, this option covers the labelling of food of clones, offspring and
descendants. The following two sub-options have been identified: 
- Sub-option 1:
labelling of food from clones 
- Sub-option 2:
labelling of food from offspring 
- Sub-option 3:
labelling of food from descendants 
Labelling of food
as stemming from these animals is not a self-standing option. Whether such
labelling is voluntary or compulsory, it is subject to two main conditions: (i)
the identification and traceability of animals and their reproductive material
(RM), and (ii) the traceability of the food.  These two requirements imply
costs in addition to the cost of labelling as such as described in paragraphs
5.3.2. to 5.3.3. below. 
(ii) In
terms of modality of labelling, the following two options have been
identified: 
- sub-option 4:
voluntary labelling 
- sub-option 5:
compulsory labelling. 
The modality of
labelling is particularly relevant for consumer protection and is assessed in
further detail under paragraph 5.3.4. The voluntary labelling could be
of interest to FBOs when it represents an added value for selling their
products, which would enable them to cover extra costs. It would be put in
place by some FBOs depending on market demand. The mandatory labelling
implies that costs are borne by all FBOs, who have to check whether the food
derives from clones, offspring and/or descendants. 
The
requirements increase exponentially with the generations as shown in table 5 below:

Table 5
Conditions of identification/ traceability  to be fulfilled 
to label food
from clones, offspring and descendants of clones 
 Food from : || CONDITIONS OF IDENTIFICATION/TRACEABILITY 
 CLONES || OFFSPRING 1st generation || DESCENDANTS 
 2nd generation || 3rd generation || etc. 
 Food || LA || RM || Food || LA || RM || Food || LA || RM || Food || LA || RM ||   
 Clones || X || X ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
 Offspring ||   || X || X || X || X ||   ||   ||   ||   ||   ||   ||   ||   
 Descendants || 2nd generation ||   || X || X ||   || X || X || X || X ||   ||   ||   ||   ||   
 3rd generation ||   || X || X ||   || X || X ||   || X || X || X || X ||   ||   
 4th  etc. ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   ||   
LA : live animals
; RM reproductive material 

5.3.2. Economic
impacts in EU - costs

Labelling
requires confidence that its content is correct. To provide the information as
to whether food was obtained from clones, their offspring or their descendants
on the label, it is necessary to create a documented link between a food and
the animal/animal clone. 
This requires that
parentage information for every food producing animal is conveyed through the
food production chain. This becomes more costly with every generation between
the clone and the animal, reproductive material and the food. 
As explained above (section 2.6.1.) current
legislation on traceability does not conserve the require link between an individual
animal and the food obtain thereof throughout the food production chain. It
does not ensure the link between the animal and its parents throughout all
stages of livestock production. As a result to label food derived from clones,
their offspring or their descendants, production processes would have to be profoundly
amended to ensure such link.
It is obvious
that, depending on the sub-option chosen, costs can vary substantially. This
was also highlighted in the consultations, where industry representatives
expressed themselves against labelling of food from offspring and descendants
(as highlighted in Annex II and Annex III paragraph 3) and underlined the risk
of trade disruption.  Representatives of European farmers/cooperative
associations[69] consider that traceability extended to offspring puts an
administrative burden on operators at all levels of the supply chain.

a) Sub-option 1: food from clones 

While no precise
numbers exist, it can be presumed that few animals will be cloned as the
conventional breeding techniques will remain mainstream and the cloning one
ancillary. Evidence indicates that productivity increases resulting from use of
cloning technique as currently performed are marginal. 
There is thus
little economic incentive to use it. As a result the technique would not be
used for food production in the EU up to 2020. Moreover, as set out above, the
clone itself does usually not serve as source for food. 
The consultant[70] thus presumed that if these assumptions are correct the clones in
circulation would be so few and that they could be closely traced with limited
efforts. The consultant could, however, not demonstrate that this is really the
case.

b) Sub-options 2
and 3 - Cost of traceability of food  of
offspring and descendants  

To the contrary
of clones, the traceability of food from offspring and descendants implies a
higher number of conditions (see Table 5), which increase exponentially per
generation and which need to be fulfilled. 
In particular, both
farmers and breeding companies have to adapt their registration and
traceability systems and to introduce the information related to the status of
their offspring or descendants and their reproductive material (see (i) below).
Moreover, a
traceability system would have to be set up which links every piece of meat,
and every litre of milk to a specific animal. Due to the complexity of such
system, the multitude of actors involved and the uncertainties surrounding the
functioning of existing systems costs could not be calculated. However, surely,
they come at a cost (see ii below). 
(i)     Traceability at the level of farmers and breeders
The costs for
adapting traceability systems of animals and their reproductive material have
been calculated by the consultant[71] on the basis of costs per operator (working time[72] and investments).

They were
divided into: i) one-off learning costs to familiarise with new requirements;  ii)
one-off  investments in equipment; iii) annual operating costs for recording
information on  status and parentage ; and  iv) annual  reporting and
inspection costs to respond to information requests from customers and control
authorities. 
As shown in Table 6 below, the costs for farmers have been
qualitatively assessed and considered marginal. The costs for breeding companies
(importers and established in the EU) as well as importers of live animals would
be low: the one off costs per operator range between 3 000 € and 3 600 € and
the annual costs per operator around 100 €.  
These costs should be, in principle, relatively limited as EU
operators have already the obligation to introduce information on all animals in
systems in place in the EU (see Section 2.6.1. above). In practice, the cost is
most likely to be higher because of the number of animals concerned.  
Table 6: Cost
of traceability for offspring and descendants and their reproductive material
(RM)
 in € || EU farmers || Live animals || Breeding companies 
 EU Importers  || EU Importers || EU Producers  
 Number of operators || Over 7 million || 22 || 69 || 215 
 Learning || Learning all operators   || Marginal || 71 000 || 251 000 || 783 000 
 Per operator || Marginal || 3 227 || 3 637 || 3 641 
 Compliance || Investments in equipment || Minor modifications to existing systems || Not available 
 Operating costs || Marginal || Marginal 
 Reporting & inspection || all operators || Marginal || 2000 || 8 000 || 22 000 
 per operator || Marginal || 90 || 116 || 102 
* Source ICF GHK
study tables 8.6, 8.7 and 8.8.

    

ii) traceability of food and link with the
individual animal 
Operators would need - throughout their operations - to be able to
recognise whether every food is derived or not from progeny of clones. This
would require a detailed and sophisticated (probably
electronic) traceability system.  Without such a system, linking the food of
progeny (over generations) to the animal clone is unworkable[73]. The setting up and implementation of such a
system would produce require major investments and maintenance costs that the
consultant was unable to estimate as shown in Table 7 below. 
Table
7: cost of traceability of food of offspring and descendants in non-segregated
food supply chains
 In € || Slaughterhouse / markets/ assembly centres || Importers food   || Food processors/ manufacturers  || Wholesalers || Retailers 
 Number of operators || 15 491 (bovine only) || 715 || 81 993 (all species) || 82 801 (all species) || 623 812 (all species) 
 Learning || All operators || 713 000 || 30 000 || 3 772 000 || No data || No data 
 Per operator || 46 || 43 || 46 || No data || No data 
 Compliance (invest-ments and operating costs) || Unfeasible – no quantitative data  
 Reporting and inspection || All operators || 1 426 000 || 6 000 || 7 544 000 || Marginal || Marginal 
 Per operator || 92 || 8 || 92 || Marginal || Marginal 
Source ICF GHK study tables 8.6, 8.7 and
8.8.
The consultant argued
that these costs would be avoided in food supply chains if all actors involved
(farmers, slaughterhouses, cutting plants, traders, etc.) “segregate” between  “clone/progeny”
or “non-clone/progeny” .  
While this may
limit implementation costs in terms of traceability, segregation would still bring
about considerable market disruption, since a large part of the market of food
would be not accessible for certain FBOs. It is not possible to quantify these
impacts. 
However,
considering that the number of animals concerned
increases exponentially per generation (for example, for one single bull the
number of offspring can be as high as 5,000 to 10,000; for the 2nd
generation up to 140,500 descendants and up 662,000 of the following 3rd
generation, etc. (see details in Annex XIII paragraph 2). The repercussions on the market place for food could be very
substantial[74].
While
quantitative figures are not available, any additional costs are particularly
relevant for meat, which is already very price-sensitive and where margins are
generally low. 
The
traceability of milk is even more difficult and costly than meat as it is systematically
mixed from different animals at farm level and would need, separate collecting
tanks[75] at farm level and all following stages of the supply chain
(transport, dairy, retail, etc.). The dairy industry[76] explained that separate milk collection is strictly speaking
feasible as it happens already for animals under medical treatment[77] but the likely
consequence of having to label milk from progeny of clones is that farmers
would avoid having those animals on their farms (see Annex III paragraph 3). 
At the
following stages of food processing (such as meat products, dairy products and milk
ingredients such as casein, etc.) the link with the animals concerned becomes
more difficult and costly to establish as it imposes detailed segmentation of
the different food products (or raw materials) before the processing can take
place[78].  
As regards
SME's, they cannot be excluded from any of the
traceability requirements mentioned above. This option has therefore a
potential to impact SME profit margins and growth in particular as they do not
benefit from efficient production systems and/or economies of scale enjoyed by
larger firms. Labelling could present particular challenges for micro and small
enterprises but there may be some differences among Member States (see Annex
X). 
Thus, the traceability
requirements for food poses risks of triggering significant impacts on the EU
supply chain due to changes in third country trade patterns, mainly in meat
(see Section  5.3.3. below). In case third countries' operators would be unable
to label the food from offspring or from descendants, EU buyers would seek
alternative supplies, which would result in changes in the distribution of
demand across the supply chain. 
The impacts on
the different Member States would depend on several factors, in particular the
importance of animal production and their dependence on imports. As 60 % of EU
total production of dairy and beef originate in four Member States (France,
Germany, Italy and United Kingdom), it could be assumed that in principle the
farmers, breeders and FBOs in those Member States would be relatively more
affected than those in the other Member States. 
During the
consultations, industry representatives expressed themselves against labelling
of food from offspring and descendants (as highlighted in Annex II and Annex
III paragraph 3). They also underlined the risk of trade disruption.  In
particular, representatives of European farmers /cooperative associations[79]  consider that
traceability extended to offspring represent a real administrative burden for
the whole supply chain without benefit to consumers and would be faced with
legal uncertainty as they would depend entirely on accuracy of information
provided by third countries. They would rather be in favour of using voluntary
information schemes.  Professional organisations who responded to the "IPM
consultation" also expressed themselves against (around 65%) labelling of
food from offspring and descendants of clones (including the association
representing the European food industry[80]).  
Conversely
consumer organisations, animal welfare associations and individuals, expressed
themselves by a very high majority (between 75% and 90%) in favour of traceability
system of reproductive material from clones and of labelling of food from
offspring and descendants; results also showed that the absence of information
was - wrongly[81]- perceived by consumers as an issue of food safety. Some industry
representatives[82] suggested during the consultations (Annex II) to inform generally
consumers about the benefits and risks of cloning so that they would be well
informed and would no longer have unfounded concerns. 

c) Cost for changing the label of the food  

Compared to the
costs for ensuring traceability the costs for re-designing and re-printing
labels are negligible. Estimates provided by the Commission impact report on
food labelling range between 2000-4000 € for a small label change and between
7000-9000 € for full label redesign and per operator.  Results of other studies
also show limited costs (see Table 8 below).
Table 8 cost of labelling of food products
 European Commission (2008) Impact Assessment Report on General Food Labelling Issues || Average cost at company level for a small label change: €2,000-4,000 per stock keeping unit (SKU); Additional cost for full label redesign: €7000-9000. 
 Private Label Buyer  (2011) Special Report — Labelling || Cost of redesigning a small private label line of approximately 100 SKUs: $100-$3000 (€77 to €2320) in design fees ; Photography and illustration costs could more than double total cost 
 Defra (2010) Developing a Framework for Assessing the Costs of Labelling Changes in the UK   || Average costs of changing a label for a food manufacturer: Voluntary redesign 4857 £/SKU (€6050) Implementing of new legislation 2945 £/SKU (€3670) ; Average costs for country of origin labelling for meat – large company: £600 - £1,150 (€748 to €1433). 

Source: Defra
(2010) Private Label Buyer (2011) European Commission (2008) 

The economic
impacts of labelling depend also on whether it is voluntary (sub-option4) or
mandatory (sub-option5): 
Sub-option 4
(voluntary labelling): operators interested in differentiating their
products would label food as not stemming from clones, offspring or descendants
on a voluntary basis. They could in these cases offset the additional costs
(linked for example to private control schemes) by a higher selling price in so
far as  there is market demand for such (more expensive) products and they can
trace the food as described in section 5.3.2. (b) above.
Sub-option 5
(mandatory labelling): unlike in the case of voluntary labelling, the costs
set out above for sub-options 2 and 3, would fully incur if the labelling was
mandatory. So if extended to offspring and descendants the additional cost would
have to be borne by all (as explained in second indent of Section 5.3.5. below).
   

5.3.3.
Economic impacts on trade with third countries 
a) sub-option
1: food from clones 

The cloning companies and breeders in some third countries already
register their animals as clones on a voluntary basis as reported in the
consultations (see section 1.2.2.). The cost for third country breeders has not
been estimated but the cost for identifying clones and their reproductive
material can be reasonably the same[83]as estimated for the EU and therefore relatively low (e.g. around
20,000 € if companies decided to set up a database of clones and around 4,000 €
per company to upgrade their registration and traceability system of
reproductive material[84]).  

b) sub-option
2: food from offspring  

If food from offspring of clones would need to be traced and
labelled to be exported to the EU, the adaptation costs would be much higher in
third countries[85] than in the EU for food from offspring and descendants. Third
countries generally[86] do not dispose of individual animal identification and of national
databases as the EU does. It is very unlikely that third country operators
would afford such costs for the EU market only. No third country has expressed
any readiness to put in place the identification and traceability system.
 
In fact, EU's
trading partners have repeatedly stated[87] that no measures should be imposed on the reproductive material and
on offspring of clones by the EU; they underlined in particular that “there
is no scientifically justifiable basis for imposing a regulatory
differentiation between the progeny of clones and other animals of the same
species” and “that restrictions specifically aimed at food from progeny of
clones – such bans or labelling requirements – could have negative impacts on
international trade”. They also pointed out that “science-based
verification of audit and enforcement measures on progeny would be impossible”
and “that systems put in place would be potentially subject to fraud”
(see Section 5.5. below on control).  
This option may
therefore create major trade disruptions with the EU[88].  Exports of live animals and their reproductive material to the EU
would also need to specify whether they originate from offspring or descendants
so that EU FBOs could label their future food accordingly. 
The trade at
risk for food could be substantial. Food imports of meat, milk and milk
products are worth approximately € 3.6 billion each year[89]. 

c) sub-option 3: food from
descendants

If food from
descendants of clones would need to be traced and labelled to be exported to
the EU, third countries would first need to put in place a system to trace the
offspring and their reproductive material (as described in sub-option 2 above)
which is unlikely. In addition, as for offspring adaptation costs would be much
higher in third countries[90] than in the EU. In view of the reluctance of third country
operators to afford costs for tracing offspring and their reproductive material[91] this option would
be clearly rejected by third countries. This sub-option may therefore create
even more trade disruptions with the EU[92] in food and in live animals and their
reproductive material.  

5.3.4. Impacts on consumer protection 

a) sub-option 1:
 food from clones
This option has
a positive impact on consumers but as limited to food from clones, may not
satisfy totally their request.  In view of the consumers' negative perception
towards cloning, it is likely that FBOs would not market this food if "mandatory
labelling" is requested and would not label it either on a "voluntary"
basis.  
b) sub-option 2:
food from offspring 
This sub-option
brings in principle an added value in terms of protection of consumer interests
as it is to offer consumer choice but does not cover food from clones.  There is
also a considerable difference between voluntary and mandatory labelling for
this type of food. 
c) sub-option 3:
food from descendants
This sub-option
should offer an even higher benefit for consumers but would not make much sense
if food from clones and from offspring would not be labelled. In effect, as
shown in the consultations held, consumers have an interest for consumer choice
linked to cloning and a partial one limited to descendants would not satisfy
their expectations.  
 
d) sub-option 4:
voluntary labelling 
In the case of voluntary
labelling and if there is a market demand, the FBO could see an interest in
differentiating their products. In this case, the voluntary labelling, would
probably be "negative", i.e. specify that the food does not derive
from cloning. FBOs have no interest in advertising food from clones, food from
progeny of clones considering the strong negative attitude of consumers. It is
therefore reasonable to assume that, based on consumer preferences, the market
would decide for a "negative" labelling. This approach would however
only offer a fragmented picture to consumers: not all FBOs would indicate the
non-cloning origin of their food.  As a result, consumers would not know
whether unlabelled food is in effect derived or not from clones/progeny of
clones. In addition, it is also possible that no FBO would decide to label, in
which case consumers would not be informed. 
e) sub-option 5:
mandatory labelling 
Conversely, mandatory
labelling would create a clear picture for consumers and a level playing
field for all operators. It should be "positive" (i.e. specify that
the food derives from cloning) in order not to impose a burden on farmers,
breeders and FBOs not involved in cloning. Mandatory labelling provides for a
clear and uniform consumer information and thus put consumers in the position
to choose but, as explained above, it is very costly to implement.  

5.3.5.
Impacts on food prices and employment  

The extra cost
of positive voluntary labelling (as described in Section 5.3.4. (d) above)
would be borne by consumers and would probably relate to local food production
(e.g. cheese produced exclusively from local bovine breeds) which uses
exclusively traditional breeding techniques, therefore limiting the cost of
voluntary labelling and giving to the food an added value. 
In the case
mandatory labelling (as described in 5.3.4. (e) above)
there would be an impact on production costs due to the cost of the
obligatory traceability system and the pressure on suppliers to be able to
prove whether their products derive or not from offspring or descendants. There
could be a price increase for food which could be transferred to consumers, if
elasticity of demand is low. If not, this would have consequences on breeders,
farmers and importers who would need to bear additional costs and even suffer a
reduction in activity and employment, in particular for SME's.

5.3.6..
Impact on Animal Welfare

 5.4. Option 4: temporary suspension of the technique and of imports of live clones, their reproductive material and their food. 

Under this option animal welfare problems are not
addressed. 

5.4.1. Description of the
option

The temporary
suspension of the cloning technique in the EU would ensure that Member States
do not adopt national measures for welfare reasons, offering thereby legal
certainty and clarity. Live clones, their food and their reproductive material
would therefore not be produced on the EU territory. 
Imports of live
clones[93], of their reproductive material would need to be suspended to
ensure a level playing field between all breeders and farmers in the EU and
ensure full consistency with the suspension of the technique in the EU.
As the
technique may evolve over time and alleviate the welfare concerns, the
suspension would need to be linked to a scientific review to assess whether it
should be maintained or stopped, based on the possible technological evolution
of the technique.  
The suspension
of food of clones would address consumer perceptions on the use of food from
animal clones; it would complement the suspension of the technique and of
marketing live clones. 

5.4.2.
Economic Impacts 

As far as
the EU is concerned, Member states have confirmed that cloning is not used for food
production and therefore, no food from clones and no reproductive material from
clones is produced on the EU territory. No food from clones has been imported
so far in the EU and imports of live animals are in any case very limited.
Therefore the expected economic impact of the temporary suspension of the
cloning technique, of the clones and of their food is not expected to be
significant to the contrary of reproductive material as explained below (Annex
XI). 
- Suspension of the technique 
The suspension
would have limited effect as no cloning is taking place in the EU. In the
hypothesis that cloning for food production were more used in the EU, an
increase in farming sector productivity could in principle be expected as the
technique aims at reproducing elite animals[94]. However a recent economic study[95] estimated that the increase of productivity in the milk sector
would be limited to 0.35%, which is minimal compared to the annual productivity
increase of 1.5% observed in Europe between 2006 and 2009 without cloning
activity. 
Representatives
of European farmers and agri-cooperatives[96] confirm that there is limited interest of European livestock
keepers in cloning in view of the high cost of the technology but still
consider that cloning could represent an interest in specific cases such as the
preservation of valuable genetics (see summary of positions in Annex III
paragraph 3 and Annex XIII paragraph 2 for the cost of cloned animals). This is
also confirmed by the meat association[97] as other breeding methods work better and faster for the purpose of
animal selection; nonetheless cloning might in their view become more relevant
in the future (minutes of meeting in Annex II).
            - Suspension
of reproductive material of clones 
The actual
impacts on Member States of suspending the reproductive material of clones may
differ according to the importance of their livestock. As shown in Table 1 (see
Section 2.6.3. above), imports of reproductive material from third countries are
on average low (2.5 %) but represent in certain Member States more than 20 %.
It is not known how much of this imported reproductive material is obtained
from clones or from conventional animals. It is difficult to assess whether
there are major differences regarding the impact of this suspension according
to Member States, particularly as the breeding sector requires continuous
exchange of high quality reproductive material especially for high output
species. 
During the consultations and interviews with the consultants, EU
breeders and farmers underlined that it is important to continue to have access
to this genetic material to be able to decide on their strategies to improve
the productivity on a large base of genetics and improve or maintain their
competitiveness (Annex XIII paragraph 4). 
            - Suspension of food from clones 
As clones are
not reared for food, it is unlikely that third country trading partners would from
now on export food from clones to the EU in the future. This has not happened
so far also because of the obligation to submit such food to a pre-market
approval under the current Novel Food Regulation. Food industry in third
countries where cloning technique is used would either remove food of clones
from their food chain or remove it from the food exported to the EU. Taking into
account the low number of clones and the fact that already today food cannot be
imported as long as there is no PMA, this option has a very limited impact.
 Regarding
impact on competitiveness (Annex IX), the
suspension of cloning technique in the EU is not expected to have direct
effects on EU breeding companies, as there is no commercial cloning
activity[98] expected for food production until 2020. Possible impacts on cost
competitiveness are expected to arise through the additional costs incurred in
assuring that inputs meet the terms of the suspension in the EU and the
contingent risk of loss of access to imports of live animals, their food and
reproductive material. EU farmers (especially in the bovine meat/dairy and
ovine sectors) would benefit from loss of competition from imports of food
(meat and milk production) in scenarios where exports from third countries to
the EU are disrupted or lost. 
Although research
is not covered by this policy initiative, the potential for research may be
affected if the commercial exploitation on the market is restricted. For
example, cloning is used as a means to research in genome editing (which
enables to identify at an early stage the productivity potential or other
qualities of the adult conventional animals). Innovation in the breeding and
farming sector could be more difficult to achieve in the EU and have serious
long-term consequences on the ability of European farmers to access improved
genetics, if European breeding organisations, which are global leaders, would
relocate their activities outside the EU. It is therefore essential under this
option, to consider the suspension as only a temporary measure so as not to
discourage research and innovation in Europe and adapt the suspension to the
evolution of the technique regarding its impacts on animal welfare. 
As reported in
Annex III paragraph 3, the organisations representing farmers, breeding sector,
food industry as well as research institutes[99] expressed support for continuing and encouraging research in animal
cloning. One organisation in particular[100] acknowledged the concerns of health and welfare linked to cloning,
considered that they should be further addressed through research and that a
broader analysis would be needed in the longer term to assess the benefits of
cloning.  
Regarding
SME's, it is not possible to exclude them from the
temporary suspension as this would undermine the objectives of providing for
uniform conditions of production for the whole farming sector while ensure
adequate protection of the welfare and health of animals.  The impact on SME's
mirror those expected on businesses as a whole (see Annex X).
Third
countries would, under this option, not be allowed
to export live clones, their food and their reproductive material to the EU.
The impact for live animals would be limited as trade of live animals is
generally very low (in total only around 40 bovines and around 800 porcine
imported in the EU in 2011) the cost of identification and traceability of
clones in third countries is relatively low (see paragraph a) Section 5.3.3
above).  The impact on food would be insignificant in third countries as of
today food from clones can only enter the EU market subject a pre-market
authorisation, which has never been requested and as clones are not produced to
this end it is unlikely the situation will evolve. The pragmatic approach
already adopted by some third countries (see footnote 6 in Section 1.2. above)
is to exclude the clones from the food chain on their territory. The suspension
of exports of reproductive material of clones could have an impact but it is
difficult to specify in the absence of any quantification of this material. 

5.4.3. Impacts on consumer protection 

This option has
a positive impact on consumers: their concerns about animal welfare will be
addressed as no cloning would take place in the EU. Consumers will have more
confidence on the origin of products they are purchasing as food from clones
would be forbidden and no food from offspring produced in the EU. However, they
would not be able to make informed choices on food from descendants and
imported food from offspring.  

5.4.4.
Impacts on prices and employment 

The expected
‘direct’ employment impacts of the option of suspending the cloning technique
and the use of clones is considered not significant because few EU jobs are
sustained by commercial cloning for the farming sector. The potential
employment impacts could arise through the induced and indirect effects of the
legislation. Efforts to confirm compliance with the suspension legislation in
particular for the reproductive material would create employment in the supply
of verification services but this growth would come at the expense of
employment elsewhere (more supply chain resources would be channelled into
compliance activities at the expense of core business). It is however not
possible to quantify such impact due to the lack of data available.
As regards food
prices, no impact is expected as the technique is not currently used in the EU
(see Annex IX).

5.4.5.
Impact on Animal welfare 

This option has
a positive impact on animal welfare, as it creates a level playing field for
all farmers and breeders in the EU who no longer be able to make recourse to
it. The suspension would be maintained a long as the concerns on animal welfare
and health are not alleviated and be subject to scientific review so as to
assess whether it should be maintained or stopped. 
 5.5. Impacts on control (applicable to all options including non-policy change) 
Control on the
implementation of any measure on cloning by control authorities can only be
based on documentary and traceability systems, set up and managed by the
successive operators along the food chain including in third countries where
the cloning activity takes place. 
Physical
controls based on analytical methods are not possible as the DNA of the clone is
identical to the DNA of the donor and therefore the derived products
(reproductive material and food) of clones and of progeny cannot be
distinguished via laboratory testing. This could create potential legal uncertainty
for operators, who would not be in a position to attest by analytical methods
that the animals, reproductive material or food they have procured is derived
or not from cloning. 
There would be
no additional costs for Member States' control authorities as regards  the
controls of intra-Union trade and imports of live animals,  their reproductive
material and their food. The absence of additional costs is due to the fact
that live animals, their reproductive and food are already submitted to
specific official controls both as regards those produced in the EU and those
imported[101]. Therefore, the additional information required as a result of this
policy initiative would not trigger new activities by Member States. Conversely,
additional resources would be required from FBOs (as described in Section
5.3.2) to check the reliability of the traceability systems, which support the
labelling of food of clones and their progeny.
The effectiveness of
control relies primarily on third countries' readiness to put in place the
identification and traceability systems of the clones as any of the policy
options are dependent on this prerequisite. Controls in third countries can be
ensured by the Food and Veterinary Office (FVO) which would verify that
breeding companies and food operators exporting to the EU have put in place the
necessary identification and traceability systems of the animals, reproductive
material and food to ensure proper and reliable information. There would be no
impact on the EU budget as the FVO already carries out inspections in the fields
covered by this policy initiative. 

6.         
Comparing the Options

The ranking of
the impacts and objectives per option is given in detail in Annex XII. 
A summary of
the ranking is given at the end of this Chapter. The impacts in terms of
economic (costs), consumers (freedom of choice) and social (prices of food
& employment) are compared for the various options.  As the options have no
or very limited impact on environment (biodiversity), this criterion does not
appear relevant to rank the options. All measures on cloning would produce costs
for operators for part or for the food chain. These costs need to be justified balanced
by added value in terms of animal welfare and consumer protection.  

6.1.           
Comparing the options in terms of impacts
6.1.1.
Option 1 (no policy change) 

This option has
the lowest economic impact but only partially addresses consumer protection and
welfare. It implies costs on FBOs interested to market food from clones as this
requires pre-market approval of food. It allows labelling of approved products.
Yet as there is no commercial interest in the marketing of food from clones, the
actual implementation of PMA is unlikely.   
As to welfare,
in light of the EFSA opinion, full implementation by Member States of the
Directive 98/58/EC on animal welfare implies in principle that the cloning technique
is not used for food production in the EU. This option has thus a positive
impact on welfare. It has no impact on FBOs in general as they can under this
option continue to import animals and food. 

6.1.2.
Option 2: Pre-market approval of food from clones to food from offspring and
descendants

This option
triggers impacts due to the multiplication of application dossiers for the
required market authorisations for both EU and third country operators, to
unavoidable additional burden on EFSA, to the necessity to trace the animals
and their reproductive material in addition to the food. In the absence of food
safety issues, the measures under this option are not proportionate in
particular as regards food from offspring and descendants. 
   

6.1.3.
Option 3: labelling of food (from clones, offspring and descendants)

This option requires
the traceability of animals, of their reproductive material and of the food to
enable FBOs to label the food. 
a) For sub-option
1 (labelling food from clones), the impact on both FBOs and third countries is
limited.
b) For sub-options
2 and 3 (labelling of food from offspring and descendants) the costs for
traceability would be substantial. The costs increase even further with the
inclusion of each generation and with non-segregated food supply chains because
of the underlying need for more sophisticated traceability systems. This is
particularly the case when the labelling is compulsory (sub-option 2 and
3 combined with sub-option 4). 
 c) in the case
of voluntary labelling of food from offspring or from descendants (sub-options
2 and 3 combined with sub-option 4): FBOs would be able decide to label the
“non-cloning origin” of their food if they dispose of the necessary information
upstream. If this information is limited to the traceability of clones and
their reproductive material and offspring, as foreseen in the Commission
report, the impact is limited. However as labelling would be decided by FBOs,   consumers
would only be informed scarcely. 

6.1.4.
Option 4: temporary suspension of the technique and the use of clones (food and
reproductive material)

This option
ranks higher than option 1 as it creates legal certainty for all EU operators
and applies in a coherent manner to the use of the technique as wells as to the
use of clones. Its efficiency depends on its scope: 
(i) if limited
to the technique, to clones and their food, the impact on EU FBOs and trade is
limited as trade, if any, is likely to be extremely low and FBOs overall have
no interest to market food from clones. The suspension of the technique would
not impact negatively on innovation and research as it would be temporary and
signal that research, (not touched upon by this policy) needs to be pursued. The
possible use of imported reproductive material of clones (as mentioned in
section 5.4.2. second indent above), justified for economic reasons, would not
diminish the effects of this measure as the welfare of animals reared in the EU
would be secured by the suspension of the technique in the EU and the
suspension of live clones. 
 (ii) if the
suspension would also include that of reproductive material of clones, it
offers the highest coherence with the objective of animal welfare but may
prevent EU breeders and farmers to have access to this genetic material, which
they may have had so far, and thereby undermine their competitiveness. 
Therefore the
elements of this option, which rank highest in terms of animal welfare, are the
suspension of all elements except the reproductive material from clones. Otherwise,
it ranks lower than option 1.  

6.2.                 
Comparing the options in terms of
objectives for coherence and efficiency 
6.2.1. Option 1 (no policy change) 

This option is
coherent with the objective of consumer protection but only as regards food
from clones. For food from offspring and descendants, this objective would not
be fulfilled. In addition, this option adds costs linked to pre-market
authorisation and risk assessment. 
The
implementation of Directive 98/58/EC is coherent with the objective on welfare.
It is not efficient as it applies only to the cloning technique and not to the
use of clones, which means that farmers and breeders can still import them and
use them.  
 

6.2.2.
Option 2: Pre-market approval of food from clones to food from offspring and
descendants. 

This option
provides for consumer protection[102] as it reassures consumers on safety as it applies to all food of
the animals concerned. In the absence of "novelty" for food from
offspring and descendants and in the absence of food safety issues, it is
unjustified and incoherent to impose any PMA for this type of food,
particularly as the food in question must in any case comply with the
legislation on food safety (hygiene, control, additives, etc.). The PMA for
offspring and descendants is also disproportionate; as described in section
5.2.2 above, unjustified costs would need to be borne for FBOs (linked to risks
assessments and application dossiers, to the required traceability requirements
of the animals concerned and of their food) and trade disruptions most likely.  
Therefore, the element of this option,
which ranks highest, is the pre-market approval of food from clones. 

6.2.3 Option 3: labelling of food (from clones, offspring and
descendants)

Sub-option 1 (labelling of food from
clones) would rank highest as not having any impact on trade but this type of
food is unlikely to be marketed. 
Sub-option 2
(labelling of food from offspring) combined with sub-option 5 (mandatory
labelling) for all food, would not be efficient as very
difficult to put in place. In addition, it would considerably disturb trade with
third countries and not attain the general objective (as described in  section
3.1). 
If sub option 2
is combined with option 4 (voluntary labelling) it would rank lower than
mandatory labelling and option 1.  
Sub-option 3 (food from descendants) would be totally inefficient if mandatory
(combined with sub-option 5) as unfeasible to put in place. If voluntary
(combined with sub-option 4) it would not meet consumer expectations.
Sub–option 3 ranks therefore lowest. 
Therefore, the
elements of this option, which would rank highest in relative terms are the
mandatory labelling of food from clones (sub-option 1 combined with sub-option
5) and of fresh meat of offspring (elements of sub-option 2 combined with
sub-option 5).  

6.2.4.
Option 4: temporary suspension of the technique and the use of clones (food and
reproductive material) 

This is the
only option (together with option 1) which addresses animal welfare. In terms
of achieving the objective of creating uniform conditions for farmers while
resolving the welfare issue, this option ranks higher than option 1. The
freedom to conduct business might be restricted but this would be justified for
the purpose of protecting animal health and welfare[103]. The objective of animal welfare can therefore be best achieved at
Union level with this option. The suspension of the use of reproductive
material of clones would not be coherent with the objective of safeguarding the
competitiveness of the EU farming sector. Therefore, the elements of this
option, which rank highest, are the suspension of the technique, of imports of
clones and of food. 

6.3.                 
Table summarising the impacts
 
 OPTIONS   || Economic impact/ costs   || Effectiveness in reaching the objectives 
 Animal welfare || Consumer  protection 
 Option 1   No Policy Change: Pre-market approval + labelling of food from clones on case by case + Directive 98/58/EC on animal welfare. || 0 || + || + 
 Option 2     Pre-market approval : Food from clones                      Food from offspring and descendants || 0 - - - || 0 0 || 0/+ 0/+ 
 Option 3 Labelling of food [104] || Food from clones   || Mandatory labelling of food from clones (sub-option 1 + sub-option 5) || 0 || 0 || ++ 
 Food from offspring     || Voluntary labelling of food from offspring (sub-option 2 + sub-option 4)   || 0 || 0 || 0/+ 
 Mandatory labelling of food from offspring (sub-option 2 + sub-option 5) || - - - || 0 || +++ 
 Food from descendants ||   Voluntary labelling of food from descendants (sub-option 3+sub-option 4) || 0 || 0 || 0/+ 
   Mandatory labelling of food from descendants (sub-option 3+sub-option 5) || - - - || 0 || +++ 
 Option 4 (Suspension in EU) || Cloning technique || 0 || +++ || ++ 
 Clones || 0 || +++ || ++ 
 Reproductive materials of clones || - - || 0 || 0 
 Food from clones || 0 || 0 || ++ 
                                                                                      Table 9  Summary
of comparison of options of Section 6

7.         
Monitoring and Evaluation

In order to
monitor and evaluate how the two specific objectives are implemented and
performed in the various options, the following monitoring indicators could be used:

Objective 1: To ensure uniform conditions of production of farmers in the EU
while protecting health and welfare of farmed animals:  Scientific progress
could be monitored by EFSA for both option 1 (to assess whether cloning is
still a breeding that causes unnecessary pain) and  option 4 (to  measure  whether
the suspension should be stopped, amended, for example in terms of coverage or
be maintained); 
Objective 2:
To protect consumer interests as regards food from cloned animals : 
- for both
options 1 and 2, the number of applications made (and approvals given with
labelling requirement) for food subject to a pre-market authorisation enables
to assess which food has been authorised and which  food (if any) could not be
authorised and for which reasons;
- regarding
option 3, specific surveys at national or EU level could assess which food is
labelled on the EU market, if consumers' attitude has changed towards cloning,
the effects of the measures on FBOs; statistics[105]
on the number of clones/offspring/descendants raised in the EU or imported
would also give a picture of their share in the EU livestock.  
-------------------

ANNEXES

ANNEX I: Glossary.. 54
ANNEX II: Minutes of the Advisory Group and bilateral
meetings with stakeholders. 56
ANNEX III: Consultation stakeholders. 77
1. State of Cloning in Member States – Summary. 77
2. State of Cloning in Third Countries – Summary. 82
3. Stakeholders position. 90
4. Third country competent Authorities. 92
ANNEX IV: IPM summary report and original questionnaire.. 94
Annex V: Executive summary of the ICF-GHK study on the
impact in the EU and Third Countries of EU measures on animal cloning for food
production.. 109
ANNEX VI: Summary of EU requirements on the
identification and traceability of life animals and reproductive material and
novel food   127
ANNEX VII: Baseline Scenario (Economic) 136
ANNEX VIII: EU statistics on imports of live animals,
reproductive materials, meat, meat products, milk and milk products (sources
COMEXT and TRACES) 149
ANNEX IX: Impact in the EU and Third Countries of the EU
Measures on Animal Cloning for Food Production – Effects on Sector
Competitiveness  166
ANNEX X: SME Test. 180
ANNEX XI: Analysis of Impact on Trade in case of
Suspension of Cloning Technique.. 188
ANNEX XII: Comparison of options on impacts and of
options according to Objectives. 189
1: Comparison of
options on impacts. 189
2: Comparison of
options according to objectives. 190
ANNEX XIII: Baseline Scenario (Background Information) 191
1. Technical Description of the Cloning Process. 191
2. Price of Cloning, Cloning Activity Projected to 2020
and simulation of the number of offspring and descendants. 192
3. Background Information on Cloning-Companies, Number of
Clones in third countries and Supply Chain Management for clones in the US. 194
4. Genetic Diversity. 196
5. World Holstein Friesian Federation Guidelines for
Registered Clones. 197

ANNEX I: Glossary

"Artificial
Insemination": Can be described as the
injection of semen from a superior-quality male in the reproductive tract of a
female to make her pregnant.
"Breeding": Consists in selecting the most suitable
animals as parents of the next generation so as to improve[106] on a
regular basis the performance (in milk production, amount of muscles,
resistance, longevity etc.) of the following generation(s). The improvements
can bring high economic returns at breeding and farm level and be disseminated
widely especially thanks to the high reproductive rates of the animals, the use
of artificial insemination, embryo transfer, in-vitro fertilisation and more
recently the use of genomic selection. 
"Breeding
animals": Pure breed animals companies with
high genetic value which produce reproductive materials (semen, embryos and
ova) to perform artificial insemination or embryo transfer (males and females
detained by farmers which are used for natural mating or calf production are
excluded). 
"Cloning": Means a technique of asexual, artificial reproduction with the aim
of producing an identical or nearly identical copy of the original animal by
transferring the nucleus of a cell from the donor animal into an enucleated
oocyte which is subsequently implanted into a surrogate mother (cloning does
not involve any genetic modification).
"Conventional animals": For the purpose of this report, conventional animals means all
animals other than those having a cloning background (clones, offspring and
their descendants).
"Descendants (second and further
generations)": Means an animal produced by a
traditional breeding technique, where none of its parents is a clone but at
least one of its ancestors was a clone.
"Embryo
Transfer": It consists in using a very good
female to produce embryos (with the genetic material of both the female and the
male). Each embryo from this female is transferred to surrogate mothers to give
birth to the actual animals.
"EU Food Law": (Regulation (EC) 178/2002): establishes the common basis
for food law in Member States and includes common definitions, general
provisions and specific requirements such as food traceability.
"Generic
authorisation": The pre-market
authorisation is granted to all operators who can put the authorized product on
the EU market provided they respect all the specifications and conditions of
use.
"Genome editing": Small changes or moving polymorphisms within a breed.
"Genomic Selection": Is a technology that incorporates information from tens of thousands
ADN positions to determine directly from the genome of an animal its genetic
merit and future production and performances.
"Gross profit margin": describes the difference between revenue (price of a product) and
cost (total costs incurred in production).
"Herd
book":  A book containing the list and
pedigrees of one or more herds of choice breeds of cattle, pigs etc.; - also
called herd record, or herd register. 
"Individual
authorisation": The pre-market
authorisation is only granted to the operator who filed the application.
"In-vitro fertilisation": Is a process by which an oocyte is fertilised by semen outside the
body of the animal to be then transferred into a surrogate female.
"Offspring (first generation)": Means an animal produced by a traditional breeding technique,
where at least one of its parents is a clone. 
"Pre-market approval": Is a regulatory measure according to which, new food products have
to be authorized by the competent Authorities before being placed on the EU
market.
"Reproductive material": Means the semen, ova and embryos of animals to be used for
traditional breeding techniques. These materials are produced by the breeding
companies and used by farmers to obtain animals intended for meat and milk
production. 
"Segregated food supply chain": Means that food operators would treat separately (on a separate
processing chain or at a different period) the carcasses, the meat or the milk
of clones and their progeny in order not to mix it with meat or milk from
conventional animals. Basic identification and traceability (e.g. colour code)
is sufficient not to mix the two types of food products.
"Selection farms": Farms of animals with high genetic values used for the genetic
improvement of specific breeds. In order to estimate the genetic value of these
animals it is necessary to have an individual identification of them and at
least to know the father and the mother of the animal.
"Whole food supply chain": Means that food operators would treat simultaneously and on the
same processing chain the carcasses and meat from i) clones and their progeny
and ii) from conventional animals. This would require the setting up of new
traceability systems or the upgrading of existing ones (such as those used for
beef labelling of the origin). N.B. not possible for milk when mixed in the
same tank.
"Surrogate mothers": A surrogate mother is a female animal who bears a cloned embryo.
She carries and gives birth to an animal that she is not the biological mother.
"Traditional
reproduction techniques": Are artificial
insemination (AI), embryo transfer (ET) and natural mating (NM) used in the
sexual reproduction of farm animals.
"Veterinary Health Certificate":
Is an official document signed by the official
veterinarian certifying in accordance to general provisions laid down in
Directive 96/93/EEC that the animals or products thereof meet certain generic
(e.g. no clinical sign of disease) and specific (e.g. being tested with
negative results) health requirements.

ANNEX II: Minutes of the Advisory Group and bilateral meetings
with stakeholders

1.  Plenary meeting of the Advisory Group
on the Food Chain and Animal and Plant Health 16 March 2012 (Point 5 of the
agenda).
2.  Working Group of 14 May 2012 on the
Impact Assessment of measures on animal cloning for food production in the EU
(Agenda and Summary). 
3.  Plenary meeting of the Advisory Group
on the Food Chain and Animal and Plant Health 26 November 2012 (Point 8 of the
agenda).
4. Report on the meeting of 20 September
2012 with EFFAB (European Forum of farm Animal Breeders).
5.  Report on the meeting of 25 October
2012 with EDA (European Dairy Association).
6. Report on the meetings of 5 September and
10 October 2012 with UECBV (European Livestock and Meat Trading Union).
7. Report on the meetings of 12 September
and 8 November 2012 with COPA-COGECA (European Farmers and European
Agri-cooperatives).
8. Report on the meeting of 18 December
with UECBV (European Livestock and Meat Trading Union).
1. Plenary meeting of the Advisory
Group on the Food Chain and Animal and Plant Health 16 March 2012 (Point 5 of
the agenda).
Impact assessment in the EU and third countries of
measures on animal cloning for
food production in the EU.
COM presented the state of play of the Commission impact
assessment on animal cloning for
Food production; briefly clarified the terminology used
and explained individual roadmap policy options. COM offered links to all
available relevant information and informed participating organisations of the
various general, as well as targeted consultations which are scheduled in the
near future. COM also mentioned its request to EFSA to update its opinion on
cloning by June 2012.
COM presented the external study for the collection and
analysis of data, the main objectives
of which are to analyse the feasibility of options and
to assess socio-economic and environmental impacts. COM asked participating
organisations to provide written positions
by 30 April 2012 and that public consultation using the
Interactive Policy Making tool (IPM)
will be available on its website by April. The impact
assessment will be finalized by the end
of 2012. COM's proposal on animal cloning for food
production is planned for 2013, as indicated in the road map which has been
recently published.
COM's contractor, GHK Consulting, presented the main
goals of its study, which are to examine the feasibility and the impacts of
various policy measures that would govern animal
cloning and the marketing of derived products in the EU,
ranking from suspension of the cloning technique in the EU, the setting up of
traceability systems for reproductive materials
from clones and live clones and offspring, to pre-market
approval, traceability and mandatory
labelling for derived foodstuffs.
GHK explained that the analysis will apply to several
species (cattle, pigs, sheep, goats and
horses) and be built around a model of the market that
captures the EU production, imports
and exports and a simplified schematic representation of
the full supply chain. The external
study will be finalized in the summer of 2012.
Comments and questions raised:
FESASS commented on the differences in legislation in
the EU and 3rd countries and asked how the different implementations of legislation
would be treated in the study.
GHK confirmed that these would be considered in the
study.
FOODDRINKEUROPE asked what types of questions are in a
questionnaire sent to the Member States and whether they are related to
traceability. It also raised the question of novel
food and asked when it is foreseen to come forward with
the legislation on cloning and novel food, whether they would be separated and
what the time line is.
COM clarified that at the moment it has only been
decided to present a proposal on animal cloning, which is scheduled for 2013.
Regarding the novel food legislation, there is no decision yet on when it might
be presented. With regard to the questionnaire sent to the Member States, COM
pointed out that the questions are related to traceability and possible
labelling and recording in the Member States.
EDA expressed concern about the feasibility of tackling
such a broad issue within the given timeline. If stakeholders are to be asked
to provide relevant data, sufficient time is needed.
In reply to a request from EUROGROUP FOR ANIMALS on
public consultations, COM gave further details, in particular that the
questionnaire for the general public will be available
on the Your Voice in Europe website in April for
a twelve-week period.
COM/GHK clarified to FESASS that there is indeed the
intention to categorise different costs
in the study so that it shows clearly which costs are
related to the setting up of the traceability
and labelling system.
2. Working Group on the Impact Assessment of measures on animal
cloning for food production in the EU (Agenda and Summary). 
 || EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Safety of the Food Chain Innovation and Sustainability   
Brussels, 14 May 2012
D(2012) 
Working
Group of the Advisory Group of the Food Chain, Animal Health and Plant Health
on the impact assessment of measures on animal cloning for food production in
the EU
Summary
report
14
MAY 2012
Participants:
Commission - DG Health and Consumer:
Chantal Bruetschy (Head of Unit E6)
José Luis de Felipe Gardón (Deputy Head of
Unit E6)
Stakeholders:
please see list attached
1. Introduction
Ms Bruetschy, Head of Unit E6, chaired the
meeting. She explained that the purpose of the meeting, in the framework of the
impact assessment procedure, was to collect the stakeholders' views on the
possible measures to regulate the use of cloning for food production in Europe,
as set out in the published roadmap. The aim of the impact assessment is to define
the most appropriate policy while ensuring the functioning of the internal
market, respecting the WTO agreements and guaranteeing consumer information. 
2. General positions on cloning
CIWF stated its position against cloning,
based on two general problems: the welfare issues for clones and the surrogate
mothers and the fact that the technique will be used to produce copies of
animals genetically selected for high yields despite the EFSA reports showing
that high yielding animals often suffer from serious health and welfare
problems. In this regard, the representative felt that current animal welfare
legislation is not up to date on problems of high yield animals. He emphasized
the need for ethic consistency and thus that any measure on offspring should take
into account that such animals are the result of the use of the cloning
technique at some stage. He also worried that feasibility hurdles would serve
as an excuse for inaction. Finally, he stressed that the absence of safety
issues does not make the problem of cloning less relevant to consumers.
UECBV is of the view that cloning is not of
great interest for the meat industry in Europe today, as other breeding methods
work better and faster for the purpose of animal selection, but that cloning
might become relevant in the future. However, cloning is currently used in
third countries that have trade relations with the EU. The uncertainty
regarding the usage of the technique in the world would make identification and
labelling requirements difficult to implement. The representative also felt
that the tracing systems in place for cattle should not lead to an excessive
and unfair burden on the beef industry.
CLITRAVI said that WTO obligations must be
respected, as import restrictions for products related to cloning (reproductive
material, live animals and food) could be negatively perceived as technical
barrier to trade. 
COPA-COGECA stressed the importance of
SME's in Europe and that the majority of farmers are against cloning for food
production purposes, since consumers are against it. However, Europe cannot
isolate itself from the rest of the world, and the use of the cloning technique
outside the EU has to be carefully assessed. The fact that food from clones and
offspring is not distinguishable from other food raises feasibility issues for
traceability and labelling.
EFFAB mentioned that measures must be
enforceable and that animal cloning is a reproduction technique, not a breeding
technique.
HOLSTEIN UK felt that progeny from clones
and food from clones and offspring would be hard to trace and, therefore,
expressed concern about the effectiveness of possible legislation.
EUROGROUP for ANIMALS is not in favour of
cloning for the same reasons exposed by CIWF. They believed that farmers that
buy breeding material to improve the yield of animals should have information
on where the reproductive material comes from. 
BEUC stated its position against the use of
cloning for food production, given the great dissent of consumers. The
representative stressed that consumers should have the right to choose and
that, if marketed, food from clones and offspring should be labelled.
FOODDRINK EUROPE has yet no official
position on cloning; however it felt that, given there is no food safety but
only an animal welfare issue, the topic relates more to actors upstream in the
agricultural industry than to consumers. Possible measures should avoid trade
disruptions, be proportionate and enforceable, and preserve the trust of
consumers in the food industry. 
3. Detailed discussion
To help the discussion, it was suggested to
divide the theme into four main streams: 
a) current traceability of reproductive
material/live offspring, b) possible tracing of reproductive material from
clones/live offspring from clones, c) labelling and d) pre-market approval
a) Current traceability of reproductive
material/offspring
Cattle:
HOLSTEIN UK said that for pedigree animals, it is possible to know the ancestry
of animals and reproductive material. 
COPA-COGECA and UECBV observed that not all
animals are purebred and registered in herd books, as it is not mandatory.
Moreover, COPA-COGECA and HOLSTEIN UK pointed to the cross-bred animals, which
are also not in the herdbooks. The percentage of cross breeds varies between
25% and 50 %, depending on the breed.
FVE held that farmers sometimes trust an
expert breeder and choose the semen based on production expectations rather
than based on its ancestors. In relation to this, COPA-COGECA mentioned that
farmers may follow breeding programs to select the reproductive material they
buy. In both cases, farmers may not be interested in the identity of the sire.
Pigs: In
most cases, breeding takes place with artificial insemination (AI) and no
longer with natural mating (in some countries AI is reaching 80-90 %). COPA-COGECA
said that, when AI is used, it is done with fresh and not frozen semen. Semen
is traded in limited amounts.
Goats: 
Farms are usually small and not attached to breeding organizations. The
percentage of AI is very low (it dropped considerably compared to 20 years ago,
maybe between 5 % and 10 %, exact figures are not available),UECBV observed
that in the Netherlands production of breeding material for goats was stopped
because it was not profitable.
b) Possible tracing of reproductive
material from clones/live offspring from clones
HOLSTEIN UK said information on whether an
animal is a clone can be included in the supporting documentation of pedigree
animals, but that it would be difficult to verify the reliability of this
information. However, not all Holsteins have a pedigree. The representative
stressed that individual identification of animals does not exist in many
countries, making a global certification system an unlikely possibility.
UECBV said that, in order to be credible, a
declaration on import certificates should not be based on the information on
herd books only. It should instead be supported by official certification from
public authorities. However, the representative considered that this measure
could put the EU at risk of retaliation. 
A database with information on individual
animals, similar to the one in place for European cattle, would only be useful
if the major trade partners had one. This is not seen as a realistic
possibility. Finally, a system restricted to European production would
represent an unfair burden on European farmers, decreasing their
competitiveness.
CLITRAVI stated that a traceability system
based on unreliable information would open the possibility for food scares. The
representative doubted that third countries, such as the USA, would accept a
measure requiring official certification of imports.
EDA noted that, today, imports are allowed
on the basis of the information provided by official certificates. They thus
considered that inspections on procedures and official certificates would be
sufficient to guarantee that foreign producers provide reliable information on
reproductive material from clones and live offspring. Although less preferred,
a system of "own check" procedures could work as well. This would force
foreign producers, who wish to export into the EU, to have a procedure in place
to guarantee reliable information.
EFFAB reiterated the statement of
COPA-COGECA on the impossibility of checking if a product involved cloning at
some stage. FVE mentioned that a clone can be recognized by testing DNA. 
Reacting to CLITRAVI’s statement on
unreliable traceability system and food scares, BEUC stressed that information
is key to building consumer confidence in the food system. Rather than waiting
for news stories on “cloned” food to appear in the media – which will also
result in costly food scares -, BEUC emphasized the importance to have, as soon
as possible, a reliable system in place to inform consumers. UECVB thought that
giving reliable information to consumers is important in this respect and
mentioned the hormone free beef scheme as an example.
Horses are usually not bred for food
production purposes, but EDA said imported sports horses can be slaughtered and
enter the food chain. COPA-COGECA said AI is not allowed in several major
breeding organizations. Only geldings could need to be cloned, as they cannot
reproduce naturally.
c) Labelling
CIBC noted that mandatory labelling would
have the consequence that food from clones and offspring from clones would not
be marketed and that no label would then exist in Europe.
UECVB are not in favour of labelling. They
stressed that labelling must be based on a good traceability system with strong
guarantees on the reliability of the initial information. This is particularly
important because the technique is perceived negatively by consumers. FVE
suggested cloning could become a positive attribute in the future and that
labels would be perceived as a value added to products. UECVB responded that,
currently, this is not the case. They felt that the likely consequence of
labelling would be the interruption of imports of reproductive material from
clones. 
EUCOLAIT noted that any measure relating to
food from offspring and descendants of clones (suspension, pre-market approval
or mandatory labelling system) would effectively block imports of dairy
products and likely be challenged at the WTO. As regards labelling of products
from offspring and descendants born in the EU, EUCOLAIT considered that it
would be difficult to label processed milk products because the milk comes from
many animals. EDA responded that, in the production process, separating the
milk of specific cows is feasible and is done regularly in the case of animals
under medical treatment. This could be done also for cows that are clones or
offspring from clones. However, it is likely that as a consequence farmers will
avoid having clones and offspring from clones in their herd. Finally, EDA
stressed that a labelling system should not be retroactive and should include a
transition period.
CLITRAVI expressed the view that labelling
of food from clones could create trade disruptions.
CIWF noted that retailers and consumers in
Europe do not want cloning and that justifying measures with the WTO would not
be impossible. The argument would need to be constructed properly, based on
consumer perceptions and behaviour, the clause on public morals and case law.
FOODDRINK EUROPE does not have an official
position on labelling yet. It noted that in Europe, so far, labelling has
killed technology and that it would be difficult to guarantee reliable
information at all. It believed that labelling of food from clones could create
trade disruptions.
BEUC stressed the importance of informing
consumers and that trust is always involved in the business to business relation
between producers and their suppliers. Consumers have not supported products
deriving from new technologies when they do not see the benefits for them of
using such technologies. Also in the US, consumers have strong concerns over
the use of animal cloning for food production and consumer organizations in the
EU and US, through the Transatlantic Consumer Dialogue (TACD), issued a joint
resolution in 2008 for the suspension of food from clones. Reacting to a comment
that it would be very difficult to impose labelling on imported food of animal
origin, the representative said that, even though direct labels would be the preferred
option also for third country products, country of origin information could be
used by consumers as an indication of the possibility that cloning took place
at some level of the production chain.
EUROCOMMERCE has no position on labels yet.
In general, retailers aim at offering consumers what they expect.
COPA-COGECA expressed a preliminary position
against labelling of food from offspring of clones because it does not see
traceability as a feasible possibility. Farmers are not likely to take the risk
of having clones and offspring form clones in their herds. The result of
labelling would be to segregate the production flows of food from clones and
their offspring and food from conventional animals. In the medium term,
restricting the commercial use of the cloning technique could have a negative
impact on the competitiveness of European farmers. They considered that if a
certification system would be required only at European level, an unfair burden
would be put on European producers with respect to producers outside Europe.
Finally, COPA-COGECA underlined that research would only be pursued if it has
prospects of commercial application.
EFFAB worried that labelling and
traceability measures would hinder research on cloning in Europe, which would
risk decreasing the competitiveness in the future. 
There were no particular comments on
descendants of offspring of clones or on the pre-market approval measure.
AVEC, ECSLA, FESASS, INFOAM EU, UEAPME and
OIE did not express an opinion on the questions raised.
4. Conclusions
COM thanked the stakeholders for their
contribution and asked them to complete the public consultation questionnaire
with all the necessary technical explanation and data where possible. 
Participation list
Table 1: ADVISORY GROUP MEMBERS
 1 || AVEC || Association of Poultry Processors and Poultry Import and Export Trade in the European Countries 
 2 || BEUC || Bureau Europeen des Unions de Consommateurs 
 3 || CLITRAVI || Centre de liaison des Industries Transformatrices de viandes de l'Union Europeenne 
 4 || COPA-COGECA || Comité des organisations professionnelles agricoles de l’Union européenne – Confédération générale des coopératives agricoles de l’Union européenne 
 5 || ECSLA || European Cold Storage and Logistics Association 
 6 || EDA || European Dairy Association 
 7 || EUROCOMMERCE || European Representation of Retail, Wholesale and International Trade 
 8 || EUROCOOP || European Community of Consumer Cooperatives 
 9 || EUROGROUP FOR ANIMALS || Eurogroup for Animal Welfare 
 10 || FESASS || Fédération européenne pour la santé animale et la sécurité sanitaire 
 11 || FoEE || Friends of the Earth Europe 
 12 || FOODDRINK EUROPE  (former CIAA) || Confederation des Industries Agroalimentaires 
 13 || FVE || Federation of Veterinarians of Europe 
 14 || IFOAM-EU GROUP || International Federation of Organic Agriculture Movements — European Union Regional Group 
 15 || UEAPME || Union européenne de l’artisanat et des petites et moyennes entreprises 
 16 || UECBV || Union européenne du commerce du bétail et de la viande 
Table 2: NON
MEMBERS
 1 || CIBC || Confederation International de la Boucherie et de la Charcuterie 
 2 || CIWF || Compassion in World Farming 
 3 || EUCOLAIT || European Association of Diary Trade 
 4 || EFFAB || European Forum of Animal Breeders 
 5 || HOLSTEIN UK || Breed Society 
 6 || OIE || Office International des Epizooties 
3. Plenary meeting of the Advisory Group on the Food Chain and Animal
and Plant Health 26 November 2012 (Point 8 of the agenda).
Impact assessment for possible measures on animal
cloning for food production – state of play on information received from
stakeholders
The Commission thanked the members for the
various position papers received on cloning issue and the responses to the IPM consultation
which are being examined. Commission also thanked for the technical explanation
(breeding issues, herdbooks, genomics, etc.) given in bilateral meetings with
COPA-COGECA, EFFAB, EDA and UECBV.
The Commission acknowledged the difficulty
for the members to obtain data related to the use and imports of reproductive
materials in the EU and invited them to share information on this for all
relevant species (bovine, but also porcine, caprine and ovine) in so far it is
not commercially sensitive. Several members agreed to do their best and
mentioned the fruitful cooperation with the Commission services on the
technical understanding of the all related aspects. 
The Commission indicated that the work on
the impact assessment report was on going and the legislative proposal on
animal cloning for food production is planned for adoption by mid-2013.
4. Report on the meeting of 20
September 2012 with EFFAB (European Forum of farm Animal Breeders)
BTO report of E6 meeting with EFFAB on cloning issue (20/09/2012)
Present:
EFFAB, Topigs,
UNCEIA representatives.
SANCO: C.
Bruetschy, J.L. De Felipe, J.F. Roche
EFFAB is the
European organisation representing the breeding sector for farm animals.
1. Use of
A.I. and embryo transfer
·        
Bovines
- EU average of 75%
of A.I. for milk production and < 10% for meat production (except for BE
breed "blanc bleu belge" with very high %).
- EU imports of
reproductive materials mainly for milk production. Around 10 % of semen is
imported (milk) mainly to UK, Irl, NL, Italy and to lesser extent DE, BE, FR
etc.
- Costs for semen
doses: 10-20 € for standard bull, 2-300 € for top bulls.

  Porcines

- Use of locally
produced fresh semen for production farms
- Use of frozen
semen (both from EU and third countries) limited to nucleus herds (selection:
multiplication farms). Only 300 bores (males) at world level are used for A.I.
with frozen semen.
- Huge development
of A.I. for meat production (95%).
- Mixing of semen to
increase fertility.
- Cloning not
interesting due to short intervals between the generations and quick genetic
improvements;

  Ovines

- Very limited use
of A.I. for ovines because not economically worthwhile (for Lacaune breed for
Roquefort production and only for selection farms for meat production).
- Use of fresh semen
only: No imports of semen.
- Mixing of semen to
increase fertility.

  Caprines

- Use of A.I. for
selection/ multiplication farms only.
- No imports of
semen.
- Mixing of semen to
increase fertility.
2. Traceability
for reproductive materials
- Imports of semen only for pure breeds with full identification of
the donor (EU health certificates).
- No mixing of semen collected by semen centres (except for porcine
and ovine);
- Straws: identification of collect centre,
animal individual identification, and date of collection.
- DNA profiles to check the identity of the donor and its parentage
but not applicable to make distinction between the original bull and its
clones.
- Use of cloned bovine for reproductive materials to continue the
semen production of top bulls when the original animals are no longer in use
but overlap cannot be excluded as frozen semen may be stored up to 50 years.
- No problem to trace in the EU imported semen from clones once it
has been declared as such (no obligation under EU legislation to do so), but no
idea about feasibility of such traceability in US / Canada.
- EFFAB has set up a code of Good Breeding practices for bovines,
porcine and poultry which is applied by breeding companies which are members of
EFFAB but not by individual farmers which can directly import reproductive
materials: to impose transit through EU agreed semen centres for registration
and control.
- Difficulty to control possible EU measures requesting third
country exporters to identify and trace semen from clones: it cannot be based
on DNA testing but on traceability systems based on documents. To set mutual
agreements based on ISO certification and to involve the Authorities at some
stage (e.g. validation of certification schemes).
5. Report on the meeting of 25 October
2012 with EDA (European Dairy Association)
BTO report of E6 meeting with EDA (25/10/2012)
Present: EDA, EUCOLAIT and Danish
Agriculture and Food Council representatives.
SANCO: C. Bruetschy, J.F. Roche
EDA represents
the EU milk industry. The EU milk sector is shared between cooperatives (60%)
owned by farmers and private companies (40%). It is the milk industry which
defines the standards and criteria applicable to milk quality (direct link to
milk price paid to farmers).
1. Trade of milk and milk products
The EU does import very few milk, cream,
butter or cheese (less than 1 % of EU production) while EU exports mainly
cheese, milk powder and butter. However, the EU imports some high value milk
ingredients amongst others from the US: MPC (milk proteins concentrates) and
WPC (whey protein concentrates) and lactose. They are intended for
incorporation in a large variety of EU milk products or foods (meat products,
sport drinks, baby foods) to strengthen the protein content.
2. Milk production
- Reproductive materials
Technical aspects to be discussed with
COPA-COGECA.
- Traceability for milk and milk products
At farm level; all the milk is collected in
the same tank (no separate collection on a regular basis would be feasible for
milk from one or two cows in a herd).
A 30 ton tanker is collecting milk each 1
to 3 days from a series of farmers.
At dairy plant level, usually one storage
facility where all the milk collected in a single day is mixed in the same
tank(s). New marketing trend for bio milk or grazing cows' milk lead to
the splitting of milk storage and processing at the dairy plant level where it
is feasible but not at the farm level (specialised in that specific
production). This segmentation is possible because of the economic interest
(higher milk price) which would not be the case with milk labelled as
originating from offspring/descendants of clones.
Therefore, EDA is of the opinion that if EU
traceability measures with a separate milk collection at farm and dairy plant
would be imposed to the milk obtained from offspring/descendants of clones,
then EU dairy farmers would exclude the use of reproductive materials from
clones. This would be a fortiori the case if a labelling requirement is
also imposed (no market for milk or milk products earmarked as from clones or
offspring from clones).
6. Report on the meeting of 5
September and 10 October 2012 with UECBV (European Livestock and Meat Trading
Union).
BTO report of E6 meeting with UECBV on cloning issue (5/09/2012 and
10/09/2012)
Present:
UECBV, Dutch and
French Federation representatives.
SANCO: C.
Bruetschy, J.L. De Felipe, J.F. Roche
UECBV is
composed of 56 national federations of meat industry including EEA countries,
Croatia, Turquia and Russia. They are competent for meat production (EU slaughterhouses
and cutting plants) and imports and exports of meat.
1. Bovines
·        
Background: EU production and trade
The EU is the 2nd
world producer for pork meat (after China) and for bovine meat
(after USA). EU is self-sufficient for porcine and poultry and in deficit
for bovine (3-4%), ovine (20-22%) and horses (80%) meat.
EU beef production
originates 2/3 from milk breeds (by product of milk production) and 1/3
beef breeds. 
EU bovine and
ovine meat production decreasing on a regular trend and
EU consumption as well. Porcine production is stable but
rentability is negative for most farmers.
EU imports bovine
meat from:
i)                 
South America (mainly Argentine, Brazil,
Uruguay) but in significant decrease (local and emerging countries demand is
increasing and other competing productions (bio-fuel, feed) severe decrease of
cattle production in Argentina partly compensated by Brazil).
ii)               
USA mainly with major increase of EU imports
(extension of UE import quota in context of new EU-US agreement on hormone free
beef production for EU). 
EU exports
bovine and pork meat in Russia mainly but also in
China, Japan, South Korea and Turkey.

  Individual identification

EU system: Based
on double ear tags (electronic identification proposed in Commission
legislative proposal which revises Regulation 1760/2000).
Third countries:
no individual identification except for Australia, New-Zealand (whole
production) and Argentina (for farms which export to the EU).
For US and
Canada feed lots (identification by batch, certification on methods of production
(hormone free etc.) before slaughtering. No information on the background and
parentage of individual animals before age of 3 to 4 months where they enter
into feed lots (A.I. and cloning would also be used for meat breeds such as
Hereford and Angus).
·        
Reproductive materials
-         
Imports of reproductive materials quasi exclusively for milk breeds (Holstein mainly), very limited
imports for beef breeds (Angus and Hereford in UK / IRL). 90-95% of I.A. for
milk production among which around 20% imported from 3rd countries.
-         
30% of EU Holstein cattle would have common
genetic with US Holstein cattle (due to imports of
reproductive materials from US). The cloning issue (reproductive materials
aspects) is in the hands of the EU milk sector (both farmers and milk
industry).
-         
Top list of 50 to 100 US / Canada Holstein bulls
with ranking system (on milk quantity, proteins, conformation of animals) with
possibility for EU farmers to order directly semen from these bulls. 
·        
Food products
-         
There would be no market for beef
identified and labelled as derived from clones, offspring and descendants. If
EU cloning legislation would set up traceability and labelling measures for
those food products, no products will be labelled in practice as meat from
clones/ offsprings/descendants would be excluded from EU production: It
would therefore potentially apply only to beef imports.
-       
According to NL federation representative, the
same objective (EU clone free beef and milk production) could be met through a
commitment of all EU operators (farmers and industry) to put in place
commercial agreements on a contractual basis with third countries exporters to
ensure the importation of "clone free" reproductive materials (and of
live animals). This could be done through a formal commitment of EU farmers
and EU meat and milk industry, as already done in the "Bruxelles
declaration" against pig castration practices in the EU (supported
by both Council and EP).
-       
Each food operator has its mandatory
traceability system for the labelling of beef origin which is chosen and
adapted by each operator depending its needs (slaughterhouse/ cutting plant /
retailers).
-       
Those traceability systems enable to trace back
from a steak to a batch of around 20 adult bovines or 100 calves originating
from various farms.
2. Ovines and caprines

  Individual identification

- On paper similar individual identification than for bovines
(except electronic identification instead of ear tag). In practice, individual
identification for ovine and caprine would not work properly: i) complexity and
high costs for electronic identification and ii) many derogations which are
foreseen by either EU Regulation (ex < 650.000 ovine for a M.S. such as in
Hungary) or decided at national level (derogation for ovine which are directly
intended for slaughtering and remain on national territory).

  Reproductive materials

- No more use of A.I. for ovine and caprine in the EU and therefore
no imports of reproductive materials from third countries.

  Food products

Imports of ovine
meat mainly from N-Z and Australia.
7. Report on the meetings of 12
September and 8 November 2012 with COPA-COGECA (European Farmers and European
Agri-cooperatives).
BTO report of E6 meeting with COPA-COGECA on cloning issue
(12/09/2012 and 8/11/2012)
Present:
COPA-COGECA representatives.
SANCO: C.
Bruetschy, J.L. De Felipe, J.F. Roche
1. Bovine
The general
problem is that there is no harmonized EU statistics, but rather information
from single countries, which is not collected in the same way. In addition, it
shows a large variation with respect to the requested figures or indicators.
Use of A.I. and embryo transfer
- High level of A.I. (around 90%) in main producing countries for bovine
milk production while only 20 % for bovine meat production (in NL it is 40 %).
- For beef production,
use of A.I. is limited to multiplication farms (breeding programs) and not use
by meat production farms. The reason for that is that AI is rarely used for
beef cows is that they are outside for most of the year and thus not accessible
for the farmer or the AI technician.
- EU average of
10-15% of imported bovine semen (would be up to 40 % in U.K. / NL for Holstein
breed) mostly managed by European subsidiaries of US / Canada breeding
companies. 
Overall imports
of the EU-27 have been about 9.7 millions doses in 2011 (Eurostat). A large
share is traded between Member States, showing the increasing collaboration
between breeding organisations in different Member States, e. g. Germany and
Austria, the Netherlands and Belgium or Denmark, Sweden and Finland.)
Semen marketed
in the EU by US breeding companies would not be from clones (commercial
agreement) but  this commercial agreement has not been confirmed by competent
professional organisations. 
- No statistics on
national production nor on intra-CE trade of semen: data are kept by the semen centres;
however, data on the use of semen at national level are collected by national
professional organisations but only for some Member States and not in a
harmonised way.
- There is no EU
statistics, Eurostat also provides figures for intra-Union trade; however these
do not always look reliable as you can find big discrepancies between the
imports of country A from country B compared to the exports of country B to
country A although the figures should be roughly the same. 
- Data on Traces are
different and lower than those from Eurostat (1.8 Million doses of imported
bovine semen compared to around 10 Million doses for Eurostat). This results
mainly from the lack of harmonisation of the registration of semen doses (by
kg, by volume, by number of doses etc.) by the competent Authorities at EU
Border Inspection Posts where the primary objective is to control the
compliance with EU animal health and zootechnical legislation.
- WHFF guidelines
(Holstein breed) on cloning (2006) requires that:
- name of cloned
calf = name of original animal followed by number 2 (2.1; 2.2 etc.).
- semen from clones
and embryo obtained by cloning technique should bear a suffix ETA /ETN for
their identification and registration.
- it is important
to note that the identification of the source animal should be recorded, too,
and that each breed association should establish its own procedure relating to
the registration of progeny of clones.

  EU Breeding organisations

- Semen centers and
breeding organisations are either cooperatives or private companies: relative
importance between the 2 types of actors varies depending Member States.
- Use of embryo
transfer in breeding programs only: to obtain mothers which will produce
reproductive bulls (100% genetic under control with embryo transfer while only
50 % with semen).
- Management by
milk/meat performance organisations with computing centres. Assessment of
breeding value based on several criteria (health, milk, meat, fertility,
longevity, functional traits etc.)
- All breeding
bovines in semen centres are registered in herd books as well as pure bred
bovines from production farmers (to be supplied only with approved semen).
- Milk farmers
produce and sell calves to meat producers of calf meat and JBB for feedlots
(JBB jeunes bovins de boucherie). Milk farmers do not register the pedigree of
the calves intended for meat production.
2. Porcine
- A.I. is the
rule (100%) for selection / multiplication schemes but also in rapid increase
for meat production.
- Very limited
imports of semen (frozen semen) and only for selection/multiplication schemes:
Use of fresh semen locally produced except for imports.
- Common
practice to mix the semen of different reproductors to produce semen doses in
order to boost fertility (no parentage traceability). This practice is not done
for selection purposes.
- Pork meat
production is very competitive and prices are relatively high for the moment,
however, feed prices as well, hence margins remain low: no market for "clone
free" pork meat. 
            3. Ovine and caprine
- A.I. is the
rule for selection / multiplication schemes.
- Common
practice to mix the semen of different reproducers to produce semen doses in
order to boost fertility (no parentage traceability). 
8. Report on the meeting of 18
December with UECBV (European Livestock and Meat Trading Union).
BTO report of E6 meeting with UECBV on cloning issue – porcine
sector (18/12/2012)
Present:
UECBV, Dutch
Federation and Pig Research Centre in Denmark representatives. 
SANCO : J.F.
Roche, J.L. De Felipe
Porcine sector:
Cloning in the
porcine sector is not in use in Europe for production purposes. This technique
is not needed for reproduction of pigs as there are large litters and a short
time interval from one generation of pigs to the next, and the costs of cloning
is not justified, either in the nucleus herds or at the production level. This
report is therefore more a description on the structure of the pig production,
the breeding and reproduction techniques used, like AI, and the trading of pigs
in the porcine sector.  
The structure of
the porcine sector is divided mainly in three levels. The nucleus farms in
which the boars and sows are present for genetic distribution, the multiplying
farms with sows producing crossbred gilts and finally the production farms for
for crossbred production and fattening of the piglets for slaughter.
AI for pigs
started in the 70' and since then is done mainly by the farmers using fresh
semen. The preservation system of fresh semen has been improved enlarging the
life time of semen from 3 to 5 days.  Frozen semen is reducing the quality of
semen and consequently the litters are small.
The use of AI is
generalized and in average the use is >90% in countries like DK and NL. For
the selection in the top of the pyramid the percentage even could reach 95%. It
is difficult to give a figure for others EU Member States. Embryo transfer
technique is not used in the porcine sector. Inseminated sows have 2.3-2.4 litter
per year. Mixed semen from 5 different boars is a common practice in the
production level in several Member States. This technique has proven to
increase the litter size with one-two more piglets per litter. Germany is not
using the mixing of semen. Nevertheless, the mixing is never done between boars
of different AI centres for sanitary reasons. In case of an animal health
problem the blockage of the AI centre has more serious implications than the
blockage of the animals at farm or slaughter level. Porcine semen is managed
via AI centres, EU approved or not, for international trade or local trade.
Boars from the top of the pyramid (breeding herds) are used in average 6-8
months and for boars used at the production level the boars are used during 1
year to 1.5 years (differs from country to country). Breeding values are
calculated for all breeding pigs and these values are used for selection of the
new generation of breeding pigs.  
As regards trade
of semen, the practice is not to import or export frozen semen but fresh semen
or live boars. A certificate of pedigree (several known generations) and a
health certificate usually will accompany this type of trade. 
Import of live
animals is very limited (Denmark and Netherlands). On the other hand a lot of
live females, semen and some boars are exported from these countries all over
the world.
At the
production level Denmark and the Netherlands are exporting 9.3 (DK, 2012) and
3,8 million (NL, 2012) piglets for fattening per year and Germany is one of the
biggest recipients. These piglets are not individually marked and cannot be
traced by pedigree, but identified by batch when they leave the farm or the
country. Production sows, mainly crossbreds, could be identified at the farm
but they don´t have a known pedigree. 
Cloning
activities in pigs is not taking place in Europe. In Canada, in a research
project, a type of transgenic pig has been cloned some years ago to produce a
pig with the capability to excrete less phosphorus than ordinary pigs. There is
no known activity on cloning for farming purposes in the EU.  There is only
cloning activities and research going on in the medical humane sector. However,
possibilities to evaluate and develop the cloning technique for research could
be important for the sector in the future.
The lack of
cloning activities in pigs is justified by the short production period for a
boar (generation interval could be 400 days for a boar) and the large litters
of pigs produced. There is no economic interest to clone specific boars as
their production life is so short and the cost of cloning is high. Farmers buy
a genetic line more than a specific boar. The genetic lines are adapted to the
different type of production and the preferences of the consumers in the
different Member States (e.g. more or less fat in the meat).   

ANNEX III: Consultation stakeholders
1. State of Cloning in Member States – Summary

The following summary contains the
information given by Member States that replied to the consultation
questionnaire. All 27 Member States have answered. 
National Legislation 
The Member States do not have special legislation regarding the
cloning technique and its use for food production purposes, with the exception
of Denmark. In Denmark cloning and genetic modification of animals,
including import and breeding, is regulated by law nr. 550 of June 24th
2005. Essentially, the use of cloning is subject to an authorisation and it is
allowed only when it is of substantial benefit for health and environmental
purposes. In addition in the United Kingdom, cloning for research
purposes is covered by the Animals (Scientific Procedures) Act 1986, but its
use for commercial purposes is not regulated.  In the Netherlands, the
Dutch Animal Health and Welfare Law forbids the use of biotechnical techniques
on animals, unless the minister decides to grant permission, based on ethical
motivations on the purpose of research. In Finland cloning is indirectly
covered by general law on vivisection and animal welfare and in Portugal by
law on the protection of animals kept for farming purposes. Finally in Germany
commercial cloning is indirectly covered by animal welfare and in case of
experimental trials permission is required. 
Use of cloning for breeding purposes
None of the surveyed authorities reports the use of the cloning
technique in breeding of species used for food production purposes, and
therefore no country has identification requirements for clones or reproductive
material from clones, except in Germany where clones are registered as
such in herd books and detained in semen centres and whose semen is exported to
third countries outside the EU. This semen is neither distributed nor used
inside the EU. The products of these cloned animals cannot enter in the food
chain.
Information from Germany, received after this consultation, confirms
that there are currently no live cloned bulls anymore in Germany. In France the technique has been used for the breeding of
race horses; a registration system for the identification of horses' birth
origin is in place. This system can provide information on the reproduction technique,
including cloning. In Spain the technique has been used successfully on bovine
only once.
Identification or registration
Member States authorities do not monitor if imported animals or
reproductive material originates from cloned animals; in most cases it is thus
not possible to know whether there have been any imports of cloned animals or
reproductive material from clones. The exception, again are  the cases of
Germany of clones of elite bulls who are registered in herd books and their
semen is marketed in third countries and the race horses in France,
which have a specific registration system (SIRE/Haras nationaux).
Animal health and welfare 
No information about improvements in the health and welfare
conditions of animals used in cloning is known to any Member State competent
authority. An "Opinion on the Welfare implications of Breeding and
Breeding Technologies in Commercial Livestock Agriculture" has been
published in November 2012 by the United Kingdom Farm Animal Welfare Committee.
No improvements in the health and welfare of animals are mentioned.
Scientific risk assessments 
The French national agency for the safety of food, environment
and work (ANSES) has published a report in September 2005 on the risks and
benefits related to cloning. This assessment is mainly focus on Bovines,
descendants of clones are considered as similar as the animals obtained by
traditional reproduction techniques and due to the reduced data it suggested to
perform more analysis and collection of data during several generations. 
The Board of the Food Standard Agency in the United Kingdom
asked the Advisory Committee on Novel Foods and Processes to conduct a
hypothetical assessment of an application of food from cloned animals (cattle
and pigs) under the EU Novel Food Regulation 258/97/EC. The main conclusions
were that: no differences in composition between meat and milk of conventional
animals and clones and their progeny, which is therefore unlikely to present
any food risk; the data on composition are limited and more evidence is
required on how different environments may affect the meat and milk; any
potential differences between conventional cattle and the progeny of a clone
were unlikely to exist from the second generation onwards and finally consumers
may want to see effective labelling of products from clones and their
offspring.  
Other Member State authorities base their opinion on the EFSA
scientific documents.
Research
Cloning is used for research purposes in the Czech Republic, Denmark,
Estonia, France, Germany, Italy, Spain and the United
Kingdom. In the Czech Republic studies focus on processes of
reprogramming of transferred nuclei – epigenetic modifications. In France,
research focused on the technique itself, on the development of cloned animals
and to study the contribution of epigenetic to the variability of phenotypes in
cloned animals. In Italy one company is working on cloning with pigs for
humane health purposes. In Spain research is pursued with the purpose of
improving the SCNT technique itself, of using pigs for human disease research
and for animal species preservation.
See summary table below.
 Country || National legislation || Use of cloning || Identification of clones || Identification of Rep. Materials || Imports of clones or Rep.Materials || Identification of imported clones or Rep. Materials || Improvements on animal health || Risks assessment || Cloning for research || 
 Austria || No || No || No || No || No || No || No || No || No || 
 Belgium || No || Yes for horses. Unknown for other species || No official registration. AWE foresees a code at the end of the name. None have been registered. || No || Yes for horses Unknown for other species || Yes for live horses. Imported horses have specific identification with a Greek letter in their name registered in the Studbook. || No Unknown for horses || No || No || 
 Bulgaria || No || No || No || No || No || No || No || No || No || 
 Cyprus || No || No || No || No || No || No || No || No || No || 
 The Czech Republic || No || No || No || No || No || No || No || No || Yes, at the Institute of Animal Science and the Institute of Animal Physiology and Genetics || 
 Denmark || Yes, Law on cloning and genetically modification of animals, law nr. 550 of June 24th 2005.   || No A permission is needed for research purposes || All cloned animals produced following the research permission are identifiable by registration of the animal. Imported cloned animals, who are regarded to be few, are not registered. || No || Unknown || No || No || No || Yes, at the University of Aarhus || 
 Estonia || No || No || No || No || Unknown || No || No || No || Yes || 
 Finland                                   || Indirectly through legislation on animal welfare and animal testing. Cloning not specifically mentioned. || Unknown || No || No || Unknown || No || No || No || No || 
 Country || National legislation || Use of cloning || Identification of clones || Identification of Rep. Materials || Imports of clones or Rep.Materials || Identification of imported clones or Rep. Materials || Improvements on animal health || Risks assessment || Cloning for research || 
 France || No || Yes. Only one company  that breeds horses for sport purposes is known to the authorities || Yes. Only for horses bred for use in sports (SIRE/Haras nationaux). || No || Unknown || No, except for horses || No || ANSES report on the risks and benefits related to cloning by (2005) || Yes, at the National Research Institute for Agriculture (INRA) || 
 Germany* || No Legislation on animal welfare. Permission for experimental trials. || There are currently no live cloned bulls in Germany || No, but they are registered in herd books. It is not possible to give exact figures on the number of clones. || No || Unknown || Unknown || No || No || Yes, at the Friedrich-Loeffler-Institut (FLI) || 
 Greece || No || No || No || No || Unknown || No || No || No || No || 
 Hungary || No || No || No || No || No || No || No || No || No 
 Ireland || No || No || No || No || No || No || No || No || No 
 Italy || No || No || No || No || No || No || No || No || Yes, the genetic center AVANTEA on pigs for humane health purposes 
 Republic of Latvia || No || No || No || No || No || No || No || No || No 
 Lithuania || No || No || No || No || No || No || No || Yes (EFSA assessments) || No 
 Luxembourg || No || No || No || No || Unknown || Unknown || No || No || No 
 Malta || No || No || No || No || Unknown || Unknown || No || No || No 
*Information received from Germany after this
consultation confirms that there are currently no live cloned bulls in Germany
 Country || National legislation || Use of cloning || Identification of clones || Identification of Rep. Materials || Imports of clones or Rep.Materials || Identification of imported clones or Rep. Materials || Improvements on animal health || Risks assessment || Cloning for research 
 The Netherlands || Indirectly through the Dutch Animal Health and Welfare Law. Special permission for research purposes || No || No || No || Unknown || No || No || No || No 
 Poland || No || No || No || No || No || No || No || No || No 
 Portugal || Indirectly through  protection of animals kept for farming purposes (Dir 98/58) || No || No || No || No || No || No || No || No 
 Romania || No || No || No || No || Unknown || Unknown || No || No || No 
 Slovak Republic || No || No || No || No || Unknown || Unknown || No || No || Yes (In cooperation with INRA) 
 Republic of Slovenia || No || No || No || No || No || No || No || No || No 
 Spain || No || Not currently || No || No || Unknown || No || Yes (Article from 2008) || No || Yes, Universidad Autónoma de Barcelona,  University of Murcia,  Research and Agroalimentary Technology Center of Aragón (C.I.T.A.) 
 Sweden || No || No || No || No || Unknown || No || No || No || No 
 United Kingdom || Only for research purposes through the Animals Act (Scientific Procedures) 1986. Commercial SCNT is not covered by the Act. || Unknown || No || No || Unknown || No || No. Report by the Farm Animal Welfare Committee. No improvements are mentioned || Yes.   || Yes. Not possible to disclose this information obtained in the course of functions under the Animal Act of 1986. 

2. State of Cloning in Third Countries – Summary

The European Union trades with partner
countries in sectors that are relevant to the cloning technique. Fifteen
countries were consulted, based on two main criteria: the countries which carry
out cloning activity and, in addition, the main exporters of meat and
reproductive materials to the EU Third Countries (Argentina, Australia,
Botswana, Brazil, Canada, Chile, China, Japan, Namibia, New Zealand, Norway,
Paraguay, Uruguay, United States and Switzerland). The following summary
contains the information given by the government authorities of Third Countries
that replied to the consultation questionnaire. 13 third countries have
answered. China and Chile did not reply to the questionnaire. For the USA,
information provided from the public authority was complemented with
information given from private companies to the Commission.
Some third countries which together supply
the majority of livestock-product imports of the European Union made a Joint
Statement on animal cloning for livestock production signed by Argentina,
Brazil, New Zealand, Paraguay and the United States of America on 16 March 2011
a second one on 26 October 2012 signed by the same countries except Paraguay. 
The main points identified in this
statement are the following:
-Regulatory approaches should be science based and no more
trade-restrictive than necessary to fulfil legitimate objectives, 
-No evidence indicating that food from clones or the progeny of
clones is any less safe than food from conventionally bred livestock,
-Progeny of clones are the same as any other sexually-reproduced
animal of their own species, 
-Restrictions on food from progeny of clones could have negative
impacts on international trade and 
-Any audit or enforcement measure on progeny of clones would be
impossible to apply legitimately and would results in onerous, disproportionate
and unwarranted burdens on livestock producers.
National Legislation 
Most authorities have stated that they do
not have specific legislation governing the use of animal clones, with the
exception of Norway in which the animal cloning is forbidden by law. Animal
clones, their progeny and products deriving from animal clones are subject to
the same regulations as conventional animals regarding food safety, animal
health and animal welfare. Regulations on the use of animals for research
purposes also apply.
In most third countries, food from clones
is not considered to be different from food derived from conventional animals,
based on the assessment of the risks of consumption of food derived from clones
(see below).
An exceptional case is Canada, where food
from clones and their progeny falls under the novel food definition and, as
such, it requires a pre-market safety assessment. Animal feed that derives from
clones and their progeny is also considered novel feed, which has to be
notified for assessment to the Canadian Food Inspection Agency prior to
introduction to the feed chain. Finally, SCNT animal clones, their progeny and
their products and by-products are considered new substances under the Canadian
Environmental Protection Act and manufacturers or importers of such substances
must notify it to the Minister of the Environment.
In Japan, the Ministry of Agriculture, Forestry
and Fisheries has imposed a voluntary ban on the use of cloning for livestock
animals except for research purposes. 
In Australia there is an explicit industry
moratorium on products of cloning entering the food supply.
Brazil is in the process to set up
legislation on cloning. The Brazilian Senate draft proposal is regulating the
activities of research, production, import and sale of cloned animals. This
project will go to the House of Commons to be analysed. The main purpose of the
project is to provide a legal framework of the animal cloning activity already
in place in Brazil, including research, and strengthen the official control. 
Use of cloning for breeding purposes
Cloning is used for breeding purposes in
Australia, Argentina, Brazil and the USA. However, since cloning is not
regulated in any of these countries, authorities do not have specific
information about these activities. 
In Canada, no companies of which the
government is aware are currently using cloning with the purpose of breeding
animals for the commercial livestock sector. One company operates a laboratory
for the purpose of harvesting elite performance horse embryos for use in
cloning but the embryos are exported and not brought to term in Canada.
In December 2011, US private companies that
engage in cloning have provided the Commission with the following data for the
number of clones of different species: 1100 bovines, 190 pigs, more than 100
horses. Cloning of goats was just starting, while no sheep had been cloned so
far.
Identification or registration
In most of the countries examined clones
are not distinguished and registered separately from conventional animals.
In Canada registration of cloned animals is
voluntary. Some livestock breed registries have provisions to identify animal
clones through a supplemental designation on the registration documents. Semen
and embryos are collected, identified and transferred in accordance with
protocols established by the Canadian Embryo Transfer Association. The
documentation for semen and embryos must identify animal clones through a
supplemental designation on the registration documents. 
In the USA, public authorities do not
require clones to be distinguished from conventional animals. However, private
companies have set up a supply chain management system for livestock, whereby
animals are registered. Cloned animals are individually identified and
registered by private companies. For reproductive materials (semen and
embryo), it is up to each breeding centre to decide whether to identify, or
not, material from cloned animals. 
In New Zealand, the New Zealand Food Safety
authority adopted a regulated control scheme, which applies to all ungulate
animals. Under this scheme, owners of cloned animals must provide the Ministry
of Agriculture and Forestry with a statement that provides information that
allows identification of the cloned animal and registration in an official
database. This measure is intended to facilitate access to foreign markets
should an importing country introduce restrictions relating to products derived
from clones. There are currently 13 cloned animals in New Zealand, most of
which are owned by the Crown Research Institute.
In Brazil, cloned animals are registered
via the breeding organisations, but the public authority does not keep this
information.
The Japanese Ministry of Agriculture,
Forestry and Fisheries keeps records of the number of cloned livestock. The
cumulative number of cloned cattle produced in Japan until 2011 is 591 cattle,
609 pigs and 9 goats.
Imports
Most government authorities said they do
not have information on the nature of live animals or reproductive materials
that are imported in their countries. Whether such imports are live clones or
reproductive material from clones is thus unknown.
In Canada a pre-import notification is
required to import clones and their reproductive material, but at this time no
notification was submitted to government authorities. No country has a system
of identification and registration in place for such imports.
Animal welfare
Argentina cited several papers as evidence
of improvements of the animal welfare implications of cloning. In their
experience of Argentine cloning techniques are not different from other
assisted reproduction techniques in use worldwide. So, in no case animal
welfare can justify any trade restrictive requirement.
 FDA recently submitted to EFSA its most
recent bibliography on scientific papers addressing this issue. The newer data
all support that the risks of health and welfare appear to be quite low.
Scientific risk assessments
Studies on the risk of consuming food
derived from clones and offspring has been carried out by scientists in several
countries and are often the basis on which third country authorities form their
opinions. 
USA, Canada, Switzerland and Japan have
carried out their own risk assessments. All these risks assessments, except the
one from Japan, include also considerations on risks posed on animal health.
Traceability and labelling
No country has traceability and labelling
systems for food derived from cloned animals and/or their offspring in place.
Switzerland, however, considers that this could be an option for future action.
Research
Research on cloning is pursued in all
countries except Paraguay, Namibia and Botswana, but authorities do not have
detailed information on it. In Canada, animals used for research purposes are
explicitly prohibited to enter the food chain or be released into the
environment. In New Zealand, research is pursued by AgResearch Limited (a Crown
Research Institute), which has an explicit voluntary moratorium preventing
products derived from cloned animals they own entering the food chain. In
Japan, research on the SCNT is promoted by the authorities competent for the
improvement and increased production of livestock.
See summary table below.
 Country || National legislation || Use of cloning || Identification of clones || Identification of Reprod. Materials || Imports of clones or rep.mat. || Identification of imported clones or rep.mat. || Improvements on animal health and welfare || Risks assessment || Traceability and labelling of clones and offspring || Cloning for research 
 Argentina || No. Indirectly through animal welfare legislation applicable to animals used for scientific purposes.      || Yes || No || No || Unknown || No || Yes  Papers cited || Yes Papers cited || No || Yes, but detailed information is not available 
 Australia || No || Yes + voluntary moratorium on products of cloning entering the food supply. || No || No || Yes. But no Government register. || No || No || No || No || Yes but detailed information is not available. Cloning is covered by national animal research guidelines. 
 Botswana   || No   || No || No || No || No || No || No || No || Yes || No 
 Brazil                                               || No. A draft proposal initiated by the Senate regulating the activities of research, production, import and sale of cloned animals in under discussion.   || Yes || Yes, the cloned animals are registered via breeding organisations || No || Unknown || No || Unknown || No || No || Yes but detailed information is not available 
 Country || National legislation || Use of cloning || Identification of clones || Identification of Reprod. Materials || Imports of clones or rep.mat. || Identification of imported clones or rep.mat. || Improvements on animal health and welfare || Risks assessment || Traceability and labelling of clones and offspring || Cloning for research 
 Canada || No. Cloning falls under Novel food legislation. Products or by-products of any animal clones or their progeny to the human food supply are subject to a pre-market safety assessment. || Yes. A few bovine artificial insemination centres in the past but euthanized since then. No entry into the food chain. One company haversting elite performance horse embryos for use in cloning and exported before the end of the process. || Yes. Some Canadian livestock breed registries have voluntary provisions to identify animal clones through a supplemental designation on the registration documents. Holstein Canada has special protocols for recording clones. || Yes.  Documentation for semen and embryos must identify animal clones through a supplemental designation on the registration documents. || Unknown. Pre-import notification requirement. At this time, no pre-import notification submitted to government authorities. || No || No || Yes, draft scientific opinion for internal reference only. || No || Yes, but such animals do not enter the food chain 
 Japan                                       || No. The Ministry of Agriculture had imposed a voluntary ban to research institutes  on the use of cloning except for the purpose of research. || No || Yes. All cloned animals in the research Institutes  are notified to the public authority and registered. Carcasses of cloned animals after research are incinerated or buried properly. || Yes. Research Institutes control reproductive materials and after use for research they shall be disposed properly by incineration or burial. || Unknown || No || Unknown || Yes, only on the risks of consuming food derived from clones (June 2009). No assessment has been conducted from the point of view of animal health and welfare.   || Yes, for animals used in Research Institutes. Products from clones have to be disposed after use for research by incineration or burial. No for offspring of clones || Yes 
 Country || National legislation || Use of cloning || Identification of clones || Identification of Reprod. Materials || Imports of clones or rep.mat. || Identification of imported clones or rep.mat. || Improvements on animal health and welfare || Risks assessment || Traceability and labelling of clones and offspring || Cloning for research 
 Namibia || No || No || No || No || No || No || No || No || No || No 
 New Zealand || No. Indirectly, market access of food derived from clones and their progeny and welfare implications for cloned animals are covered by general legislation. || No || Yes. Regulated control scheme requiring cloned livestock to be identified with an ear tag unique to each animal and listed in an official database. || No || Unknown || No || No || Yes,A  based on relevant scientific external evidence || No || Yes, it is pursued by AgResearch Limited (a Crown Research Institute), which has a voluntary moratorium preventing products derived from cloned animals they own entering the food chain. 
 Norway || Yes. Cloning is forbidden by law. Exception for research. || No || No || No || No || No || No || No || No || No 
 Paraguay || No || No || No || No || No record. || No record || No || No || No || No 
 Switzerland || Yes, Legislation on animal experiments applies needing a licence from the cantonal authorities. || No || No || No || Only once in 2005 of semen from a bull whose mother was cloned, none since. 200 live cattle with a cloned cattle in the pedigree.   || No || No || Yes, studies relate to animal health and welfare, food safety and ethical considerations. || No, but setting up a traceability and labelling  system for cloned animals and their direct offspring is one option discussed for future action. || Not for farm animals. More information in life sciences (animal experimentation) is not available. 
 Country || National legislation || Use of cloning || Identification of clones || Identification of Reprod. Materials || Imports of clones or rep.mat. || Identification of imported clones or rep.mat. || Improvements on animal health and welfare || Risks assessment || Traceability and labelling of clones and offspring || Cloning for research 
 Uruguay || No || No || No || No || Yes || No || No || No || No || Yes in vitro fertilisation. No results on live clones yet 
 USA || No. Same regulations apply as to conventionally-bred animals with respect to animal care and welfare, treatment with animal drugs, and introduction into the food/feed supply.   || Yes || No. However, there is an industry-sponsored supply chain management system for livestock, to track clones. || No || Unknown || No || Yes, FDA recently submitted to EFSA its most recent bibliography on scientific papers addressing this issue. The newer data all support that the risks of health and welfare appear to be quite low. || Yes, FDA scientific opinion. || No || Yes, but detailed information is not available 

3. Stakeholders position

In addition to the participation in the IPM
public consultation, the main sectors concerned by the animal cloning have also
provided their position paper on this issue. The different position papers from
European farmers to the European consumer association are summarized below. 
a. Farmers
and breeding sector
COPA-COGECA
as EU representatives of farmers and agri-cooperatives consider that any
measure on animal cloning should be Science-based, cost-effective and workable
in practice. They are also concerned about the possible indirect impact on
European farmers of a ban of food from cloned animals since several third
countries do not have traceability systems in place. Copa-Cogeca considered
that traceability of clones may not be problematic but imposing a traceability
scheme to offspring represents a real administrative burden for all the supply
chain without benefits for the consumers. They would rather favour voluntary
information schemes. 
BAB (British
Agriculture Bureau) feels that is inappropriate to ban a technology in
food production when there is no scientific basis for a food safety risk, as
confirmed by the European Food Safety Authority (EFSA). The UK farming unions
believe option 1 is the preferred option and importantly the most
scientifically sound option in light of the EFSA opinion that there are no food
safety issues with the offspring from cloned animals.
EFFAB (European
Forum of Farm Animal Breeders) strongly supports maintaining the status
quo. EFFAB believes that any measures must be based on sound scientific
evidence and enforceable not only by EU member States but also by third
countries. They also considered that the adverse effects of cloning technology
are limited at present and will reduce with further developments. They also
share the view of EFSA and the USA Food and Drug Administration (FDA) where
current evidences suggests that meat and milk for healthy clones or healthy
offspring of clones is as safe as that from conventional healthy animals.
EAAP (European
Association for Animal Production) and ICAR (International
Committee for Animal Recording) expressed the interest of both
organisations in supporting the research in animal cloning, independently from
the concerns that the European consumers may express in other forums. Even if
the use of cloning in animal production is limited certainly their medical
applications appear to be promising. Both organisations support clone research,
to allow the European scientists may retain the necessary tools and knowledge
to achieve beneficial goals.
The IETS (International Embryo
Transfer Society) and the INRA (Institut National de la Recherche
Agronomique), both from scientific area, considered that more research
in the cloning process and in the animal health issues needs to be encouraged.
The IETS has issued a set of guidelines based on scientific knowledge of
research teams to lower the incidence of neo-natal concerns. Concerning food
safety and labelling aspects, the IETS considered that based on EFSA and U.S.
FDA scientific opinions concluding on the lack of evidence of food safety
concerns for food derived from clones or offspring, there is no necessity to
label such food. 
The FVE (Federation of Veterinarians
of Europe) stated that there is no evidence that food safety is
adversely affected, but the public are concerned for ethical and other reasons
such as poor welfare due to a focus on agricultural productivity, a reduction
in genetic diversity and environmental impact.
b. Food industry
The dairy association EDA (European
Dairy Association) and EUCOLAIT (European Association of Dairy Trade)
both supported the status quo for which a pre-market approval for food from
clones is necessary. Offspring first generation and descendants are considered
as conventional bred and not distinguishable from any other animal of the same
species and therefore cannot be considered clones. They also based their
position in the EFSA conclusions and recommendations of 2008 followed by their
statements of 2009, 2010 and 2012 in which the safety of food from clones and
progeny are not different to those from conventionally bred animals.
The European meat sector via UECBV
(European Livestock and Meat Trades Union) and CLITRAVI (Liaison Centre
for the Meat Processing Industry in the EU) provided also their positions. In
both cases the support the status quo. In their view the EU policy on cloning
should be based in sound science, practicality to implement identification
traceability and labelling of animals and food and public concerns should be
taken into account in a balanced and proportionate manner. They also suggested
in order to prevent misinformation and unfounded public concerns the
implementation of appropriate information campaigns to explain the issues to
the public. Another key point of concern for the meat industry is the potential
trade disruption with important trade partners like USA, China, Canada, Brazil
and Japan.
Food Drink Europe organisation (EU food industry) is in favour to take measures
(identification, traceability and labelling) only on clones which are already
included in the current Novel Food regulation via the pre-market authorisation
of food from clones. They are against to take measures on offspring and
descendants of clones based on that there are no food safety concerns. In the
other hand FoodDrink Europa is in favour of the traceability of reproductive
materials from clones to be able to monitor the animal health and welfare of
the offspring of clones.
CELCAA (Agricultural
trade) considered that a complete ban or a mandatory labelling system of food
both from clones and their offspring based solely on ethical considerations
would be completely disproportionate in light of its uncontrollable economic
impact and therefore very difficult to justify. Furthermore, traders question
the feasibility of an effective enforcement of potential bans (as requested in
the past by the European Parliament), be it to prohibit imports completely. In
addition, the measures would be very difficult to defend within the WTO. 
Euro Commerce
(Commerce/retail/wholesale sector) 
Considered it is necessary to keep up with
the continued research progress on animal cloning techniques. Besides
scientific data, other legitimate factors, such as ethical considerations need
to be taken into account in the decision process. Nevertheless, Euro Commerce
has no intention to participate in the ethical debate. They also consider
essential to take into consideration the consumer acceptance on this issue in
addition to inform the citizens about animal cloning versus genetically
modified animals, the benefits, risks and impacts, so that consumers are well
informed. If products from clones and offspring of clones are authorised find a
practical solution to trace these products along the whole food supply chain.
c. Consumer
organisations
BEUC, the
European Consumers Organisation, (based on IPM consultation) considered that
the current situation does not guarantee a sufficient level of consumer
protection as food derived from offspring or descendants of clones is not
subjected to any pre-market authorisation. They state that consumers should
have the right to make an informed choice and in this case, that is to decide
whether or not they wish to eat food from clones, their offspring or
descendants. The Flash Eurobarometer on Europeans' Attitude towards animal
cloning (October 2008) found that a majority of EU citizens do not want food
derived from cloned animals to enter the food chain. A more recent Special
Eurobarometer Survey on Food-related Risks (November 2010) also showed that
cloning animals for food production is one of the most widespread food safety-related
concerns of Europeans consumers. Finally another recently Special Eurobarometer
Survey on Biotechnology (October 2010) showed that Europeans have strong
reservations and concerns about the safety of animal cloning for food
production.  
d. Animal welfare associations
Eurogroup for Animals and Compassion in World Farming are the two NGOs who have
provided a position paper on this matter. Both consider that cloning technique
is inefficient and involves severe animal suffering linked to health and
welfare problems for cloned animals and their surrogate dams. In addition, the
routine use of cloning would reduce genetic diversity and increase productivity
with insufficient attention to the animal welfare. Finally they also underline
the well-documented public concerns related to the use of cloning for food
production purposes.   
In summary, both professional organisations
of the farming, breeding and the food sectors are in favour of the status quo.
They do not support the ban of cloning technique as they consider that this
technique may improve and could be important in the future for the
competitiveness of the EU farming and breeding sectors. They are also against
any labelling measures concerning food from offspring or descendants as there
are no food safety concerns and such measures would entail additional
administrative burden and costs for operators along the food chain. On the
other hand, consumer and animal welfare organisations are in favour of a ban of
the cloning technique in the EU and of mandatory labelling for food from
offspring and descendants to provide consumer choice.
4. Third
country competent Authorities
Consultations with main trade partner third
countries competent authorities (Argentina, Australia, Botswana, Brazil,
Canada, Chile, China, Japan, Namibia, New Zealand, Paraguay, Switzerland,
Norway, Uruguay and United States of America) have taken place using a special
questionnaire to assess the situation on animal cloning for food production,
via bilateral meetings or in some cases using the IPM public consultation. Most
of the authorities do not have specific legislation governing the use of animal
cloning for food production. Animal clones, their progeny and products derived
are subject to the same regulations as conventional animals regarding the food
safety, animal health and welfare. 
Japan has imposed a ban on the use of
cloning for livestock animals and Australia and New Zealand have an explicit
industry moratorium on products on cloning entering in the food chain.
Some third countries which together supply
the majority of livestock-products which are imported in the European Union
made a Joint Statement addressed to the Commission on animal cloning for
livestock production signed by Argentina, Brazil, New Zealand, Paraguay and the
United States of America on 16 March 2011 a second one on 26 October 2012
signed by the same countries except Paraguay. 
The main points identified in this
statement are the following:
·       
Regulatory approaches should be science based
and no more trade-restrictive than necessary to fulfil legitimate objectives, 
·       
No evidence indicating that food from clones or
the progeny of clones is any less safe than food from conventionally bred
livestock,
·       
Progeny of clones are the same as any other
sexually-reproduced animal of their own species, 
·       
Restrictions on food from progeny of clones
could have negative impacts on international trade and 

  Any audit or enforcement measure on
      progeny of clones would be impossible to apply legitimately and would
      results in onerous, disproportionate and unwarranted burdens on livestock
      producers.


ANNEX IV: IPM summary report and original questionnaire

 || EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL   
CONSULTATION ON ANIMAL CLONING FOR FOOD
PRODUCTION
Summary of the replies to the
IPM consultation
This document does not represent an official position
of the European Commission. The suggestions contained in this document do not
prejudge the form and content of any future proposal by the European
Commission.
Introduction
On 3 May 2012 the European Commission
launched an IPM public consultation on animal cloning for food production. This
consultation sought to gather the views and opinions of all interested parties
on various aspects surrounding the issue of cloning for food production, such
as the use of the cloning technique, the use of clones and their reproductive
materials (semen and embryo) for breeding purposes and the use of live clones,
their offspring and descendants for food purposes. 
It targeted companies, organizations with
an interest in the matter, experts in the field as well as ordinary citizens.
The consultation was open online for 16 weeks (from 03.05.2012 until
03.09.2012). Reminders were done by the DG Health and Consumers using its
website (Flash news) and via the e-news network on 4 July 2012 reaching
approximately 6000 subscribers. Another reminder was also launched on 21 June
2012 using the Enterprise Europe Network (EEN). The consultation period ended
on 3 September 2012.
The Commission received 360 replies (56
requesting confidentiality, 150 anonymously and 154 under the name indicated):
- 99 Stakeholders (Professional Organisations, NGOs, International
organisations and Academic).
- 16 from National Competent Authorities (NCA), IRL(2), UK, AT, FIN,
DE, CZ, PT(2), FR, LX, IT and ARG (4). 
- 9 from enterprises, including  7 from SMEs (including 2 micro enterprises)
and 2 large enterprises.
- 236 from individual persons (209),
self-employed (17) and others (10).
This document summarises the responses to
the public consultation on the possible measures on animal cloning for food
production. It is in no way to be understood as an endorsement of any comment.
For the sake of brevity, consultation items are not reproduced. Therefore, this
summary should be read in conjunction with the original questionnaire and the
roadmap on animal cloning for food producing published in February 2012[107]
In addition, main comments of position
papers received from stakeholders organisations are also mentioned in chapter
3.  
The public consultation is part of the
on-going impact assessment exercise. The information and views gathered in this
public consultation will be taken into consideration in the impact assessment
process.
General remarks
The public consultation was appreciated by
the stakeholders with an acceptable participation. The vast majority of
respondents 72.5% were well informed on the subject animal cloning for food
production and also a large majority 68.6% considered that the current
situation is inappropriate and need to be changed.  Based on the participation
distribution mentioned above, some cautions needs to be exercised when drawing
conclusions from these figures as all the different categories from individual
to professional organisations or international organisation have the same value
as a single record even if the stakeholder organisations are representing a
group of persons.
The majority of the respondents were in
favour of a ban of the animal cloning covering all the different areas such as
the cloning technique, the use of live cloned animals, clone reproductive
materials, live offspring and descendants of clones and the food derived. The
most important reason was the animal health and welfare.
Concerning the pre-market approval of food
from clones, offspring and descendants of clones the majority of the
respondents were in favour of such pre-market approval given the food safety
concerns as the most important reason to put in place this measure. In the
other hand the most important reason against a pre-market approval was also the
no food safety concerns.
It is important to underline that for some
areas such as placing food from clone origin on the market and pre-market
approval there was a slight decrease in the percentage for the descendants of
clones in relation to the clones.
The majority of the respondents were in
favour of the identification and registration of clones, reproductive materials
of clones and offspring and descendants of clones. In this case also there was
a slight decrease in the percentage from the clones (86.91%) to the descendants
(71.9%). The most important reason in favour to set up this identification and
registration system was the possibility to monitor the animal health and
welfare. In the other hand the most important reason against to set up this
system was that this measure is not based on science.
Similarly to the previous areas the
majority of the respondents were in favour of a traceability system for food
from clones and offspring and descendants of clones. Again the percentages in
favour are decreasing from 88.6% for clones to 71.9% for descendants of clones.
The majority of the respondents (79.2%) considered that the traceability system
can be established and the cost should be bear by the food industry (60.3%)
covering all the species (cattle, pigs, horses, goats and sheep).
The consumers' information based on
labelling schemas was supported by a majority of the respondents using a
mandatory approach. Again there was a decrease in the percentages for the
clones (82.2%) to the descendants of clones (71.1%). The majority of the
respondents considered that all the products proposed need to be labelled and
the cost will be mainly bear by the food industry (42.8%).
Finally, concerning the proposed 5 options
nearly half of the respondents (49.2%) were in favour of option 5 on a
suspension of the use of the cloning technique in the EU, the use of clones and
live offspring of clones, the reproductive material from clones and the placing
on the market of food from clones and their offspring and descendants. The
options 1, 2 and 4 got approximately 10% and option 3 got 5%. The remaining 15%
did not select any of the options proposed.
Summary
of responses
(all respondents)
Awareness
about the developments on animal cloning for food production
A large majority of respondents were very
well (22.2%) or fairly well (50.3%) informed. Only 19.4% and 8.1% were not
respectively very well or not at all informed on animal cloning.
1. Use of
cloning technique, clones and food from clones
Nowadays the animal cloning technique is
allowed and a pre-market approval for food from clones is required in the EU.
So far no such authorisation has yet granted or even requested.
A large majority of respondents 68.6%
considered that the current situation is inappropriate, 29.7% were in favour to
keep the current situation as it is and 1.7% had no opinion.
Ban and
pre-market approval of food on the EU market 
The ban on animal cloning is covering the
cloning technique, live cloned animals for breeding purposes, clone
reproductive materials, live offspring and descendants of clones and the food
derived.
Concerning the ban the respondents replied
the following: 
 Ban || In favour % || Against % || No opinion % 
 Cloning technique || 65.5 || 26.9 || 7.5 
 Live cloned animals || 71.9 || 21.1 || 6.9 
 Clone reproductive materials || 67.2 || 26.4 || 6.4 
 Offspring of clones || 69.2 || 25.8 || 5 
 Descendants of clones || 68.9 || 26.4 || 4.7 
For all areas concerning the ban, there
were a majority of respondents from 65.5 to 71.9 % in favour of the ban on
animal cloning.
The most important reason in favour of the
ban was animal health and welfare (25.6%) followed by ethical reasons (23.3%),
reduction of diversity and genetic variety (17.2%), food safety concerns
(15.8%) and the least important reason was the restriction of access to genetic
heritage for example via patents (25.3%).
The most important reason against the ban
was the no food safety concerns (13.1%) followed by loss of innovation (8.9%),
increase of administrative burden and international trade barrier (5.3% both)
and higher costs of production and reduction of food supply (4.2% both).
Concerning the placing of food from clones,
offspring of clones and descendants of clones the respondents replied the
following:
 Food || In favour/% || Against/% || No opinion/% 
 Clones || 15.3 || 77.5 || 7.2 
 Offspring || 24.4 || 72.5 || 3.1 
 Descendants || 25 || 71.4 || 3.6 
The majority of the respondents were
against to put on the EU market food from clones, offspring of clones and
descendants of clones (77.5%, 72.5% and 71.4% respectively). It should be
noticed that the percentage against the food is slightly decreasing from 77.5%
for clones to 71.4% for the descendants.
Regarding the necessity of a pre-market
approval for food from clones, offspring of clones and descendants the opinion
of the respondents were the following:
 Pre-market approval of food || Necessary || Not necessary || No opinion 
 Clones || 78.1 || 13.1 || 8.9 
 Offspring || 68.3 || 23.3 || 8.3 
 Descendants || 66.1 || 24.2 || 9.7 
The majority of the respondents were in
favour of a pre-market approval for all food from clones, offspring and
descendants of clones. It should be noticed that the percentage for the
pre-market approval is slightly decreasing from 78.1% for clones to 66.1% for
descendants.
The most important reason in favour of a
pre-market approval was food safety concerns (26.9%) followed by animal health
and welfare (24.7%), ethical reasons (22.2%) and biodiversity and genetic
variety (20.3%).
The most important reason against a
pre-market approval was the no safety concerns (11.1%) followed by the use of
cloning technique should be banned (7.5%), increased administrative burden
(6.4%), loss of innovation (5.3%), higher cost of production (4.2%) and delay
in the marketing of the food product (3.3%).
The identification and registration of live
clones, of reproductive materials (semen, embryos and ova) and of live
offspring would be a prerequisite for the monitoring of animal health and
welfare aspects and for the setting up of traceability and labelling systems
for food products which are derived.
Concerning the identification and
registration the respondents replied the following: 
   || In favour of identification and registration of || Not in favour of identification and registration of || No opinion 
 Clones || 87.5 || 6.4 || 6.1 
 Offspring of clones || 76.9 || 17.2 || 5.8 
 Descendants of clones || 73.9 || 19.4 || 6.7 
 Clone reproductive materials || 81.4 || 11.1 || 7.5 
For all areas concerning the identification
and registration the majority of the respondents were in favour to set up a
specific identification and registration system for clones, offspring,
descendants and reproductive materials of clones produced or imported into the
EU.  
The majority of respondents considered that
the way to put in place the identification and registration system for all the
areas concerned need to be via a compulsory system. It should be noticed that
the percentage for the identification and registration is slightly decreasing
from 86.91% for clones to 71.9% for descendants.
The most important reason in favour to set
up an identification and registration system was the possibility to monitor the
animal health and welfare (from 50% to 61.4%) followed by to allow food
labelling (from 46.9% to 52.8%), the farmer knowledge that the animals are
cloned (from 43.9% to 50.8%), and to allow targeted recalls of food from the
above categories (from 35.8% to 39.7%). 
The most important reason against to set up
an identification and registration system was that this measure is not based on
science. This reason got the higher percentage in all categories.
Regarding the species to be cover by the
identification and registration the majority of the respondents considered that
all species need to be covered (Cattle 83.9%, Pigs 81.9%, Horses 77.5%, Goats
77.8 and Sheep 80.3%).
2. Traceability 
The setting up of EU identification and
registration systems for clones, clone reproductive materials, offspring and
their descendants would allow the setting up of traceability systems.
Concerning the traceability system the
respondents replied the following: 
 Traceability system || In favour || Against || No opinion 
 Food from clones || 88.6 || 7.2 || 4.2 
 Food from offspring || 77.2 || 16.9 || 5.8 
 Food from descendants || 76.4 || 17.5 || 6.1 
The majority of the respondents were in
favour of a traceability system for all the categories mentioned. It should be
noticed that the percentage for the traceability system is decreasing from
88.6% for clones to 71.9% for descendants.
Concerning the feasibility of this
traceability system 79.2% of the respondents considered that can be
established, 15.6% not and 5.3% had no opinion. In addition, 29.7% of the
respondents considered that this traceability system may lead to unacceptable
cost, 54.4% not and 15.8 had no opinion.   
Regarding who should bear the traceability
additional costs the respondents considered the food industry in 60.3% followed
by the farmers 38.6%, tax payers 38.1 ad consumers 28.1%.
Regarding the species to be cover by the
traceability the majority of the respondents considered that all species need
to be covered (Cattle 94.7%, Pigs 91.4%, Horses 85.3%, Goats 84.2 and Sheep
87.5%).
3. Consumers'
information
Traceability systems for food from clones,
offspring and their descendants would allow food producers and retailers to
inform consumers via labelling. The possible labelling schemas proposed were
none, mandatory, voluntary and others.
Concerning labelling the respondents
replied the following: 
   || No labelling || Mandatory labelling || Voluntary labelling of "clone free food" || Others 
 Clones || 6.7 || 82.2 || 5.8 || 5.3 
 Offspring of clones || 16.1 || 74.7 || 6.1 || 3.1 
 Descendants of clones || 16.9 || 71.1 || 8.6 || 3.3 
The majority of the respondents were in
favour of a mandatory labelling for clones, offspring and descendants of
clones. It should be noticed that the percentage for the mandatory labelling is
decreasing from 82.2% for clones to 71.1% for descendants of clones. 
Concerning the products to be covered by
the labelling systems the majority of the respondents, more than 80%,
considered that all the products proposed need to be labelled. They also
considered in 81.1% that such labelling can be established and that these
labelling may no cause unacceptable costs in 59.7%.
Concerning the group of stakeholders would
likely more affected for possible additional costs the respondents considered
that will be the food industry 42.8%, followed by tax payers 35.6%, farmers 35%
and consumers 33.1%.
4. Policy
options
The Commission in its roadmap on animal
cloning for food production identified in summary the following 5 policy
options: 
Option 1. Retain the current legal
framework
Option 2. Allow the use of the cloning
technique in the EU for food production
Option 3. Temporary ban of food from clones
in the EU and tracing of imports of clone reproductive materials
Option 4. Temporary ban of food from clones
in the EU and imposition of mandatory labelling of food from offspring and
descendants
Option 5. Temporary ban of food from
clones, offspring and their descendants
The nearly half of the respondents 49.2%
were in favour of option 5 followed by none 15% [to be explain looking in
detail the replies], option 1 10.6%, option 2 10.3%, option 4 10% and option 3
5%.
Summary
of the responses by categories of respondents
- Individual and self-employment
There were 226 responses from individual
(209) and self-employed (17). The majority of the respondents were from Finland
(36), United Kingdom (32), France (29), Estonia (25), Germany (18), Italy (15),
Portugal (13) and Spain (10).
The respondents in this category were very
well informed 13.2% and fairly well informed 52.2% and 34.5% were not very well
or not at all informed. In addition 73.9% considered that the current situation
is not appropriate.
Concerning the ban of the cloning
technique, live cloned animals, reproductive materials of clones, offspring of
clones and descendants of clones the respondents were in favour of a ban for
all areas: cloning technique 73% live cloned 81.4%,reproductive materials of
clones 76.1% and offspring and descendants of clones 79.6% in both cases. The
main reason expressed by the respondents to be in favour of a ban was the
animal health and welfare with a 27.4% and against the ban the main reason was
the loss of innovation with 8.8%.
In relation to the placing of food from
clones, offspring of clones and descendants of clones in the EU market the
respondents were against to allow the placing of food from clones (86.3%)
offspring (84.1%) and descendants (83.2%) of clones.
The pre-market approval was considered by
the respondents necessary for food from clones in a 88.9%, 76% for offspring of
clones and 75% for descendants of clones. The main reason for the pre-market
approval was the food safety concern.
The respondents were in favour of the
identification and registration of clones with a 87.2%, 84.5% for offspring of
clones, 81.9% for descendants of clones and 85.4% for reproductive materials of
clones. In case of the setting up of an identification and registration the
majority of the respondents were in favour of a compulsory system for clones
87.2%, offspring of clones 83.2%, descendants of clones 80.1% and 82.3% for the
reproductive materials of clones. The main reason to put in place this system
was to monitor the health and welfare of the animals. In case of identification
and registration the respondents considered that all species proposed should be
covered.
In respect to the traceability systems for
food the majority of respondents were in favour with a 91% for food of clones,
87% for offspring of clones and 86.3% for the descendants of clones.
Concerning labelling the majority of
respondents were in favour of a mandatory labelling for food from clones 89%
and offspring and descendants of clones 84% and 82.3% respectively.
Finally concerning the choice within the 5
policy options proposed 58% considered that option 5 was the most appropriate.
- Stakeholders
organisations (Professional Organisations, International organisations,
Academic and NGOs)
There were 99 responses from stakeholder's
organisations, 34 Professional Organisations, 34 NGOs, 26 Academic and 5
International organisations.
The respondents in this category were very
or fairly well informed 83.9% and considered that the current situation is not
appropriate in a 52.5%.
Concerning the ban of the cloning
technique, live cloned animals, reproductive materials of clones, offspring and
descendants of clones the stakeholders' respondents were in favour of a ban for
all areas, 54.5% for the cloning technique, 57.6% for lived cloned animals
55.6% for reproductive materials of clones 53.5% for offspring of clones and
52.5% of descendants of clones. The main reason expressed by the respondents to
be in favour of a ban was the problem of animal health and welfare and against
the ban the main reason was the no food safety concern.
In relation to the placing of food from
clones, offspring of clones and descendants of clones in the EU market the
stakeholders respondents were against to allow the placing of food from clones
64.6%, offspring 55.6% and descendants 53.5% of clones.
The pre-market approval was considered by
the stakeholders' respondents necessary for food from clones in a 81.8%, for
food from offspring of clones 59.6% and descendants of clones with a 56.6%. The
main reason for having necessary the pre-market approval was the food safety
concern.
The Stakeholders' respondents were in
favour of the identification and registration of clones with 89.9%, for
offspring of clones 64.6%, descendants of clones 62.6% and for reproductive
materials 75.8%. In case of the setting up of an identification and
registration the majority of the respondents were in favour of a compulsory
system for clones 88.9%, offspring of clones 64.6%, descendants of clones 60.6%
and the reproductive materials of clones 71.7%. There was not a clear majority
for the reasons in favour or against to put this system in place. The main
reason to put in place this system was to monitor of the animal health and
welfare. In case of identification and registration the respondents considered
that all species proposed should be covered.  
In respect to the traceability systems for
food the majority of stakeholders' respondents were in favour for food of
clones in a 85.9% and food from offspring and descendants of clones in 61.6%
for both. In case of identification and registration the respondents considered
that all species proposed should be covered.
Concerning labelling the majority of
stakeholders' respondents were in favour of a mandatory labelling for food from
clones 70.7% and offspring 57.6% and descendants 51.5% of clones.
Finally concerning the choice within the 5
policy options proposed 32.3% considered that option 5 was the most
appropriate, followed by option 1 with a 20.2%.
- Entreprises 
There were 9 responses under the category
of enterprise, 2 of them were large, 5 SME (2 small and 3 medium) and 2 micro
enterprises.
The respondents in this category were very
or fairly well informed 88.9% and considered that the current situation is not
appropriate in a 66.7%.
Concerning the ban of the cloning
technique, live cloned animals, reproductive materials of clones, offspring of
clones and descendants of clones the enterprise respondents were in favour of a
ban for all areas 55.6% except for offspring of clones and descendants of
clones with the same percentage 55.6%. The main reason expressed by the
respondents to be in favour of a ban was the possible reduction of biodiversity
and genetic variety and be against the ban the main reason was the no food
safety concern.
In relation to the placing of food from
clones, offspring of clones and descendants of clones in the EU market the
enterprise respondents were in favour to allow the placing of food from
offspring and descendants of clones with a 55.6% but for food from clones the
respondent were against with a 66.7%.
The pre-market approval was considered by
the enterprises respondents necessary for food from clones in a 88.9%, but the
pre-market approval was not considered necessary for food from offspring of
clones and descendants of clones in both cases with a 55.6%. The main reason
for not having necessary the pre-market approval was the no food safety concern.
The enterprise respondents were in favour
of the identification and registration of clones with 100%, for offspring of
clones and descendants of clones also in favour with a 55.6% in both cases and
for reproductive materials 77.8% were also in favour. In case of the setting up
of an identification and registration the majority of the respondents were in
favour of a compulsory system for clones 100%, offspring of clones 55.6%,
descendants of clones 55.6% and the reproductive materials of clones 77.8%.
There was not a clear majority for the reasons in favour or against to put this
system in place. In case of identification and registration the respondents
considered that all species proposed should be covered.  
In respect to the traceability systems for
food the majority of enterprise respondents were in favour for food of clones
in a 100% and food from offspring and descendants of clones in 55.6% for both.
Concerning labelling the majority of
enterprise respondents were in favour of a mandatory labelling for food from
clones 77.8% and offspring and descendants of clones 55.6% in both cases.
Finally concerning the choice within the 5
policy options proposed 55.6% considered that option 5 was the most
appropriate, followed by option 1 with a 22.2%.
- National
Competent Authorities 
16 replies were received under the NCA
category. 12 were coming from EU Member States and 4 from third countries. It
should be noted that 8 out of 16 did not mention the name of their
organisations at all or were regional authorities. The 10 Member States were
Ireland(2), United Kingdom, Austria, Finland, Germany, Portugal(2), Czech
Republic, France, Luxembourg and Italy. Argentina was the only third country
participating four times, one of them without mentioning the name of the
organisation and the other three from the same organisation.
The respondents from the Member States
National competent authorities were very or fairly well informed 83.3% and
considered that the current situation is not appropriate in a 58.3%.
Concerning the ban of the cloning
technique, live cloned animals, reproductive materials of clones, offspring of
clones and descendants of clones the Member States respondents were 41.7% in
favour and 41.7% against.
In relation to the placing of food from
clones, offspring of clones and descendants of clones in the EU market the
Member States respondents were against to allow the placing of food from clones
but for food from offspring and descendants it was equal percentage in favour
and against (41.7%).
The pre-market approval was considered by
the Member States respondents necessary for food from clones in a 66.7% and for
offspring of clones in a 58.3%, but the pre-market approval was for descendants
of clones there was an equal percentage in favour 41.7% and against 41.7%. 
The Member States respondents were in
favour of the identification and registration of clones 91.7%, offspring of
clones 75%, descendants of clones 58.3% and reproductive materials of clones
83.3%. 
In respect to the traceability systems for
food the majority of the Member States respondents were in favour for food of
clones 91.7%, 66.7% were in favour for the food from offspring and 58.3% were
against the system for the descendants of clones.
Concerning labelling the majority of the
Member States respondents were in favour of a mandatory labelling for food from
clones and offspring of clones 75% in both cases, in the other hand 58.3% of
the Member States respondents were in favour of no labelling for the
descendants of clones.
Finally concerning the choice within the 5
policy options proposed, options 1 and option 5 were considered the most
appropriate both with a 25% each.
Details of responses by categories of
respondents. 
The comparative tables below are presented
the detailed positions expressed by the different categories than cannot be
observed within the above global assessment. For instance contrary to the
position of NGOs and individuals in favour of a general ban of the technique
and animals derived from clones, the Professional Organisations are in favour
of the ban of the cloning technique, live clones and the traceability of
reproductive materials of clones but against any measures on the progeny of
clones. 
Concerning Competent Authorities of Member
States it should be noticed that 5 out of 12 replies do not provide the name of
the organisation they are representing and Ireland and Portugal replied twice.
For all these reasons some cautions need to be exercised when drawing
conclusions from these figures. 6 out of 10 are in favour of the status quo.
Concerning the general ban there are the same number of Member States in favour
than against. The majority are also in favour of the pre-market approval of
food from clones (7 out of 10) and offspring of clones (6 out of 10). Competent
Authorities of Member States are in favour of the animal identification and
registration and the traceability and labelling of clones and their progeny.
 Questions || NGOs || PROFESSIONAL ORGANISATIONS || Individuals and self-employed || Member States* 
 Level of information – Well informed || 94.1% || 79.4% || 65.5% || 83.3% 
 Current situation || 88.2% not appropriate || 55.9% agree with the current situation || 73.9% not appropriate || 58.3% agree with the current situation 
* The National competent authorities
of EU Member States participating in this public consultation were Ireland (2);
United Kingdom; Austria; Finland; Germany; Portugal (2); Czech Republic;
France; Luxembourg and Italy.
Cloning Technique
 Questions || NGOs || PROFESSIONAL ORGANISATIONS || Individuals and self-employed || Member States 
 Ban of Cloning technique || 85.3% in favour || 38.2% in favour || 73% in favour || 41.7% against and 41.7% in favour 
 Ban of Live cloned animals || 91.2% in favour || 38.2% in favour || 81.4% in favour || 41.7% against and 41.7% in favour 
 Ban of clone reproductive materials || 94.1% in favour || 52.9% against || 76.1% in favour || 41.7% against and 41.7% in favour 
 Ban offspring of clones || 91.2% in favour || 61.8% against || 79.6% in favour || 41.7% against and 41.7% in favour 
 Ban of descendants of clones || 88.2% in favour || 61.8% against || 79.6% in favour || 41.7% against and 41.7% in favour 
Foodstuff
 Questions || NGOs || PROFESSIONAL ORGANISATIONS || Individuals and self-employed || Member States 
 Placing food from clones || 91.2% against || 52.9% against || 86.3%  against || 50% against 
 Placing food from offspring || 94.1% against || 64.7% in favour || 84.1% against || 41.7% against and 41.7% in favour 
 Placing food from descendants || 91.2% against || 67.6% in favour || 83.2% against || 41.7% against and 41.7% in favour 
 Pre-market approval for food from clones || 79.4% in favour || 79.4% in favour || 79.2% in favour || 66.7% in favour 
 Pre-market approval for food from offspring of clones || 79.4% in favour || 64.7% against || 75.7% in favour || 58.3% in favour 
 Pre-market approval for food from descendants of clones || 79.4% in favour || 64.7% against || 74.8% in favour || 41.7% against and 41.7% in favour 
Animal identification and registration
 Questions || NGOs || PROFESSIONAL ORGANISATIONS || Individuals and self-employed || Member States 
 Identification and registration of clones || 97.1% in favour || 79.4% in favour || 87.2% in favour || 91.7% in favour 
 Identification and registration of offspring of clones || 91.2% in favour || 58.8% against || 84.5% in favour || 75% in favour 
 Identification and registration of descendants of clones || 88.2% in favour || 58.8% against || 81.9% in favour || 58.3% in favour 
 Identification and registration of reproductive materials of clones || 97.1% in favour || 47.1% in favour || 85.4% in favour || 83.3% in favour 
Traceability and labelling
 Questions || NGOs || PROFESSIONAL ORGANISATIONS || Individuals and self-employed || Member States 
 Traceability of food from clones || 94.4% in favour || 73.5% in favour || 90.7% in favour || 91.7% in favour 
 Traceability of food from offspring of clones || 88.2% in favour || 58.8% against || 86.7% in favour || 66.7% in favour 
 Traceability of food from descendants of clones || 91.2% in favour || 58.8% against || 83.6% in favour || 58.3% in favour 
 Labelling of food from clones || 88.2% in favour mandatory || 50% in favour mandatory || 88.9% in favour mandatory || 75% in favour mandatory 
 Labelling of food from offspring of clones || 85.3% in favour mandatory || 64.7% against || 84.1% in favour mandatory || 75% in favour mandatory 
 Labelling of food from descendants of clones || 82.4% in favour mandatory || 64.7% against || 82.3% in favour mandatory || 58.3% in favour mandatory 
Options
 Questions || NGOs || PROFESSIONAL ORGANISATIONS || Individuals and self-employed || Member States 
 Options || 41.2% Option 5 || 29.4% Option 1 || 58% Option 5 || 25% Option 1 and 25% option 5 

Annex V: Executive summary of the ICF-GHK study on the impact
in the EU and Third Countries of EU measures on animal cloning for food
production

Executive Summary 
Introduction 
This is a summary of a study
commissioned by DG SANCO of the European Commission from ICF GHK to inform and
support development and appraisal of proposals to regulate animal cloning in
the EU. It provides a feasibility and impact assessment of four possible
approaches to regulation of animal cloning for livestock in the EU. It includes
a description of the use of and concerns about the technique and the outlook
for livestock cloning to 2020. It then compares the expected impacts of various
measures, specified by the European Commission, through which the four
approaches would be implemented. The appraisal covers feasibility,
administrative burdens, induced costs, trade-mediated impacts, employment
effects, and then impacts on consumers, SMEs and the environment. 
There is currently a lack of
inter-institutional agreement between the Commission and the Parliament
regarding the regulation of animal cloning in the EU. A Roadmap was developed
in February 2012 to address this issue. This study will assist the Commission
as it prepares an impact assessment of the five options set out in the Roadmap.
The four approaches assessed here are: 
■ A suspension or ban on animal cloning in the EU, including
use of the cloning technique, marketing of reproductive materials from clones,
marketing of live clones, and marketing of clone offspring, descendants, and
the reproductive materials of offspring and descendants. 
■ Traceability for clone reproductive materials, live clones,
their offspring and descendants, their reproductive materials and derived food
products. 
■ Labelling requirements for food products derived from
clones, their offspring and descendants, in addition to the traceability
requirements. 
■ Premarket approval requirements for food products derived
from clones, their offspring and descendants, in addition to the traceability
requirements. 
The scope of work includes bovine,
porcine, ovine, caprine and equine animals and spans the full breadth of the
food supply chain from production to consumption. The study considers the
impacts of the four approaches on both the EU and third countries. It does not
consider cloning for research purposes, pharmaceutical production or other
commercial uses, including sport and leisure or conservation of endangered
species or breeds. 
ICF GHK acknowledges with thanks the
support given to the study by many stakeholders who participated in the
consultation and research process. 
Context to the study - livestock cloning in the EU
and third countries
 
Scientific and social context of livestock cloning 
Commercial cloning is a form of
assisted reproductive technology and may be used to replicate ‘high quality’,
high value breeding animals. It can increase the number and therefore the
availability of animals with superior genetics. Cloning can multiply the number
of such animals, but it is not a breeding technique — an animal with desirable
attributes can be replicated, but the technique cannot be used to acquire or
refine desirable traits. 
Commercial cloning is most common in
sectors where assisted reproductive technologies are already widely used and
where breeding animals carry a particularly high value. Cloning is currently
considered to be of greatest benefit in the dairy industry, where larger numbers
of high quality animals could increase overall herd milk yield, the
availability of stock with disease resistance and other desirable traits
associated with milk quality. 
Cloning has been used for bovine,
porcine, ovine, caprine and equine animals. Its use has been mostly limited to
dairy cattle and horses, however, largely due to their high value as breeding
animals. Cloning is relatively expensive and has a high failure rate, making it
viable only where the prospective returns are worth the investment. The overall
success rate of the cloning procedure is less than 10 per cent in bovine
animals and between 5 and 17 per cent in pigs. Its use in equine animals is
limited to sport horses. Little use of the technique is made for ovine, caprine
and porcine animals.
There are animal health and welfare
concerns associated with cloning, particularly the higher mortality rate of
clones compared with sexually produced animals. A majority of cloned embryos do
not develop to term and of those that do, another proportion die during or
shortly after birth from a variety of causes. Surrogate cattle dams also have
problems including late gestational loss and more difficult delivery. Studies
have shown that survival of offspring and descendants of clones is similar to
the survival of conventionally bred animals.
Studies carried out on in the EU and
third countries on the safety of food products derived from clones, their
offspring and descendants conclude that there are no additional risks
associated with consuming these products and that there is no increased risk
compared to food products derived from conventionally-bred animals.
Nonetheless, research suggests that
EU citizens and consumers are concerned about animal cloning, and oppose its
use for livestock. The supply chain does not generally perceive investment in
cloning to be worthwhile at this time due to consumer concerns, coupled with
high costs to use the technique and availability of other assisted reproduction
techniques. 
A joint statement on animal cloning
issued in 2010 by the governments of Argentina, Brazil, New Zealand, Paraguay
and the United States observes that regulatory approaches to agricultural
technologies should be ‘science based’ and should not restrict trade more than
necessary to fulfil ‘legitimate objectives’. It states that there is no basis
to differentiate offspring or descendants of clones from other sexually
reproduced animals. New Zealand is the only country that currently regulates
cloning activity. No third country identifies or tracks the offspring or
descendants of clones.
Current use of animal cloning and
the outlook to 2020 
The research suggests that there is
currently no commercial cloning of livestock animals in the EU and none is
expected before 2020. Commercial cloning of bovine animals is happening in a
small number of third countries, particularly in North America and Argentina.
Cloning is also being applied to porcine, ovine and caprine animals in third
countries, but to a much lesser extent. Commercial cloning is concentrated in
the US, Canada and Argentina, although there is some activity in New Zealand,
Australia, Chile, China and South Korea. 
Commercial cloning of beef and dairy
cattle is likely to continue in third countries. It is expected to become more
efficient and less expensive, but remain limited to high value breeding
animals. Commercial pig cloning may also become more widespread by 2020. Its
application to ovine and caprine animals is expected to remain limited. 
The most likely route for clones,
clone offspring and descendants or their reproductive materials to come into
the EU is as reproductive materials from bovine animals, and possibly porcine
animals from North America, and beef products from Argentina. Offspring of
bovine dairy clones have been produced in the EU from imported reproductive
materials from North America (two such animals entered the UK food chain in
2010). It is possible, if unlikely, that equine clones produced for sport could
enter the EU food chain when the animals reach the end of their working life or
through equine meat imports from third countries.
Supply chain and trade profile 
The supply chains that may be
affected by the proposed approaches to regulation of animal cloning reach from
‘farm to fork’, including the breeding sector, producers, markets,
slaughterhouses, cutting plants, meat and dairy processors, wholesalers,
retailers, as well as importers of live animals, reproductive materials and
food products. Species-specific information is available on the number of
enterprises involved in animal breeding and production, as well as for imports
of live animals and their reproductive materials. Beyond these points in the
supply chain the available data only provide aggregate numbers of enterprises
across the different sectors. 
The policies potentially affected a
very large number of businesses – relatively few firms in the breeding sector
but very many producers, processors and retailers. There are fewer than 10
companies operating in the EU that could conduct cloning activities (none are
known to be doing so). Approximately 300 AI companies operate in the EU
livestock breeding sector. There are an estimated 120 importers of reproductive
materials. Almost all the importers of live animals deal in equine animals,
though there are a few importers of bovine, porcine, ovine and caprine animals.

The EU has nearly 8 million
producers of bovine (3.3 mil), porcine (2.7 mil), ovine (1.2 mil) and caprine
(0.7 mil) animals. The total number of markets, slaughterhouse and cutting
plants is unknown, though there are an estimated 15,000 of these operations for
bovine animals. Further down the supply chain there are around 82,000
processors / manufacturers, 83,000 wholesalers, and 624,000 retailers of meat
and dairy products. There are around 715 importers of meat and dairy products. 
The measures assessed could affect
trade, particularly imports into the EU. At present: 
■ Parts of the EU livestock
sector are heavily reliant on imported reproductive materials, particularly
from US and Canada. Commercial cloning activities occur in both countries, but
the proportion of materials sourced from clones, their offspring and descendants
is unknown.
 
■ A small number of live
bovine, ovine and caprine animals and a larger, but still relatively small
number of porcine animals are imported to the EU each year. Due to the high
transportation costs, these are all expected to be high value breeding animals,
which the EU livestock sector also considers to be important to the breeding
industry. A relatively large number of equine animals imported into the EU each
year (11,000 in 2011), but these are all expected to be for sport and leisure
purposes rather than food production.
 
■ The EU is a net importer of
beef and veal worth around €1.7 billion per year. Sheep meat imports are valued
at approximately €1 billion. Cheese and butter are worth more than half a
billion euro, despite the EU being a net exporter of these products. 95 per
cent of beef imports are sourced from eight countries, with 70 per cent coming
from Argentina, Brazil and Uruguay. Milk and dairy products are sourced
primarily from Switzerland, New Zealand, and Ukraine and Belarus. The EU is
self-sufficient in pig meat though there is small volume of pig offal imports
from Switzerland and of pig meat, mainly from US and Chile. Sheep and goat meat
is primarily sourced from New Zealand and Australia. Around 70% of equine meat
is sourced from Argentina, Brazil, Uruguay and Mexico, most of the remainder is
sourced from Canada and the US.
Feasibility and impacts of the four approaches[108]

The individual measures provided are
not, with a few exceptions, viable in isolation so for the purposes of analysis
were combined into coherent ‘packages’ of measures. In some cases, different
strategies have also been modelled to explore the implications of alternative
possible interpretations of the stated policy objectives. For example, for
traceability, one strategy looks at the impacts assuming that best use is made
of existing traceability systems, another looks at the impacts of implemented
full traceability of every individual animal, and another looks at whether the
objectives could be achieved via voluntary approaches. 
The feasibility and impact
assessment process therefore involved, for each approach: specifying the
packages of measures; mapping these packages onto the supply chain; defining
the obligations that the packages place on different sectors and the systems
required to achieve the objectives of the different approaches; assessing the
feasibility of each package; analysing the impacts on operators and competent
authorities arising from the packages, including impacts on SMEs, EU
competitiveness, consumers and the environment. The feasibility and impacts of
the four approaches have been considered comparatively and progressively
through the supply chain, from packages that focus on live animals and their
reproductive materials through to food products. 
Feasibility 
The feasibility assessment
considered the issues involved in the construction and operation of systems
that could be developed to deliver on each of the four approaches. It focused
on technical feasibility, that is, whether a compliant system could be constructed,
as well as the strengths and weaknesses of each package of measures. 
Feasibility of packages focused on live animals –
clones 
The suspension of the cloning
technique in the EU and marketing of clones and traceability of live clones by
adapting existing traceability systems are both feasible (measure S1 / package
S-A, measureT1 / package T-A). Use of the cloning technique requires specialist
expertise and technology not widely available. Clones are high-cost animals
that would be used for breeding purposes. As such, they are highly identifiable
since operators involved in breeding such high-value animals tend to keep
detailed records of the animals. With few firms to regulate, domestic cloning
would be relatively easy for competent authorities to control. Imports are more
problematic, but there are only a small number of animals to control. Imported
live animals can be controlled relatively easily through risk-based
surveillance of trade focusing on the main sources of food production animals
with the highest levels of cloning activity.
Feasibility of packages focused on reproductive
materials from clones
 Suspension of the marketing of reproductive
materials from clones (package S-B) and traceability of reproductive materials
from clones (package T-B) under all traceability strategies are feasible
without significant adjustment to existing EU (or third country) systems. The
production of reproductive materials is already a highly regulated industry in
the EU and in the third countries from which the EU sources imported materials.
Individual identification and traceability is already enabled in the EU for all
semen and embryos. There is no known domestic production of clone reproductive
materials for bovine, porcine, ovine or caprine animals. Private sector
agreements also already identify cloned reproductive materials from bovine and
equine animals originating in the US and Canada. There is no known trade in
reproductive materials from clones of the other species. 
Feasibility of packages focused on live animals –
offspring and descendants 
Suspension of the marketing of clone
offspring and descendants (packages S-C, S-D), and the traceability of clone
offspring and descendants (packages T-C, T-D) using existing infrastructure are
both feasible, but would require considerably more adjustment to existing
systems than controls that applied only to clones. These packages are more
vulnerable to fraud than those covering only clones and clone reproductive
materials; third countries are unlikely to change their traceability systems to
ensure that imports of live animals into the EU conform to EU requirements.
Together, these issues put packages related to clone offspring and descendants
at risk of not meeting their objectives. 
Domestically produced offspring of clones
are identifiable due to agreements with North American operators to identify
reproductive materials from clones. The offspring produced from these
reproductive materials are most likely to be high-value breeding animals and
therefore, records will be kept of these animals’ parentage. Identifying
domestically produced descendants will be complicated by the record keeping
required. As descendants become part of multiplication herds, parentage
information may not be fully reliable due to mixing of animals on farm.
Incentives may not encourage compliance, especially if operating the system
entails additional cost and identification of animals as clone descendants has
an impact on their market value. 
Few live animals of the species
covered here are imported into the EU and those that are imported are ‘high
value’ animals whose heritage would normally be documented. Offspring of clones
will be relatively easy to identify since parentage records are kept for these
high-value animals for at least the previous generation. Identifying clone
descendants is much more complicated than for clone offspring because current
systems in third countries do not require traceability of clone offspring or
descendants. Assuming that the EU requires documentary evidence at the point of
import, this package would therefore require countries exporting to the EU to
establish new systems that identify each clone offspring and descendant. These
systems would need to incorporate trade in animals and reproductive materials
amongst third countries to be comprehensive. It seems unlikely adequate systems
would be built. 
Information on the pedigree status
of reproductive materials would be needed to implement these packages; such
documentation is not currently required. Systems in place in North America to
identify clone reproductive materials do not extend to reproductive materials
from clone offspring or descendants. Additional steps would need to be taken by
operators to identify these reproductive materials as derived from clone offspring
or descendants. 
‘Legacy’ presence of clone offspring
and descendants in the EU is a potential problem and a source of additional
regulatory costs for suspension and traceability packages covering descendants
because identifying all such animals could be difficult and expensive. A
decision would be needed on how to treat these animals. One option would be to
accept a low level legacy presence of clone offspring and descendants in the
food chain and focus efforts on excluding new sources. 
Feasibility of packages that require identification
of the status of all animals or batches of animals/reproductive materials 
Packages covering traceability of clone offspring (T-C,
Strategy 1 – ID all animals or batches and Strategy 2) and descendants (T-D,
Strategy 1 - ID all animals or batches and Strategy 2) are technically
feasible, but would require major changes to the systems for some species, even
where there is likely to be little, if any, cloning activity. 
A traceability strategy that requires identification of
the ‘clone status’ of all animals or batches of animals will require adjustment
to all existing traceability systems to enable an indication to be provided as
to whether or not the animal is a clone, clone offspring or descendant, or
batch of animals contains animals that are clones, clone offspring or
descendants. At present, this should be straightforward for porcine, ovine and
caprine animals, since cloning activity for these species is very limited.
Bovine animals are more complicated because offspring and descendants may be
produced in the EU. There is also an issue of ‘legacy’ bovine offspring and
descendants in the EU. 
Traceability approaches that require individual animal
identification and traceability will require significant adjustments to
existing traceability systems and may require new systems where existing
systems cannot cope with identifying the number of new animals that require
traceability. Third countries are unlikely to implement new traceability
systems in the absence of evidence on human health or safety risks. 
Feasibility of packages focused on food products 
The greatest challenge to feasibility of packages
covering food products arises from imports. Confirmation of the status of these
food products as being derived from clones, clone offspring or clone
descendants would need to rely on traditional documentary methods used in
supply chain traceability systems. This kind of documentation is not currently
required for imported food products. International trade in reproductive
materials will make it difficult to be certain that the animals, and thus food
products, from a country that does not use the cloning technique were not
actually derived from reproductive materials from clones, their offspring or
descendants obtained in another country. Extension of traceability requirements
into processed food products would not be feasible in most instances. 
Suspending the marketing of food products derived from
clones (S-E) is the most feasible of the packages covering food. The number of
potential EU suppliers is small. Proportionate systems for suspension of clone
imports are also technically feasible through working with trading partners.
The risk of clones being used systematically for food in the next few years is
low as clones are uncommon and very valuable, though there is a theoretical
risk of such animals entering the food chain at the end of their working lives
as breeding animals. Nonetheless, demonstrating and documenting that foods are
free of clones would require systems that do not currently exist. Third
countries that export to the EU would require appropriate traceability systems
or segregated supply chains, unless a pragmatic agreement was reached with
third countries to exclude clones from exports to the EU. Verification of
claims would not be possible. Moreover enforcing the suspension of use of
clones in imported food products would be a significant challenge due to the
high volume of EU meat product imports, especially bovine products. 
Constructing a system that can exclude clone offspring
(S-F) and descendants (S-G) is less feasible than one covering clones alone.
Trading partners would need to either identify and trace all clone offspring as
live animals and then trace them through the food chain to demonstrate that
exports to the EU did not contain products derived from clone offspring, or to
establish fully segregated ‘clone-free’ supply chains. The feasibility of the
system for all animals would depend on the specification of the evidential
requirements applied by the EU to imports under the new EU ‘cloning’
legislation. 
Traceability packages for clone offspring and clones
descendants (T-F, T-G) face the same challenges as suspension packages for food
products derived from clone offspring and clone descendants – identification
and traceability beyond clones themselves is difficult, if not impossible,
without completely segregated supply chains. The EU’s trading partners (and
those countries’ other trading partners) will need to adapt their traceability
systems. It seems unlikely they will do so. 
Feasibility of labelling and premarket
approvals for food products derived from clones, their offspring and
descendants
Labelling and premarket approval approaches
for food products derived from clones (package L-A, P-A), their offspring
(package L-B, P-B) and descendants (package L-C, P-C) are feasible only to the
extent to which the underlying traceability systems are feasible. The
limitations of traceability described above are thus also present for labelling
and premarket approvals. Where it is difficult or impossible to confirm that a
food product contains clones, their offspring or descendants (e.g. mixed meat
products), then it will be difficult to label these products, for example, and
there are likely to be more errors in identification.
A labelling approach that requires
‘positive’ labelling (e.g. “contains products derived from descendants of
clones”) is likely to prompt the industry to exclude products from the supply
chain that would be required to carry the positive label. This is due to the
negative perception of the cloning technique by consumers and supply chain
operators’ concern about negative responses of consumers to any label referring
to cloning. A labelling approach that required food products to be labelled
with information telling the consumer that they may be derived from clone
offspring or descendants could be used in a context where food exports to the
EU were unable to provide full traceability. This would enable imports to
continue in a way that would not be possible if declaration of clone status was
a formal requirement for import into the EU. 
A labelling approach that is voluntary and
‘negative’ (e.g. “produced without cloning technology”) is likely to be
appealing to some operators. A certification approach could be used in which
sufficient documentary evidence would confirm that the process used involved
sufficient effort by the supply chain to exclude these animals, even if the
product is not verifiable. Even so, there is a risk that the two labelling
packages covering food products from clone offspring (L-B) and descendants
(L-C) would not achieve their objectives because of difficulties in confirming
the claims made for imported food products derived from offspring and
descendants.
Impacts 
Given that little or no commercial
cloning is expected in the EU in the period to 2020, virtually all of the
impacts arising from the proposed approaches assessed in this study arise from
the development of systems to control activities and products that are not
present in the supply chain or, in the case of bovine animals, present only at
very low levels. Direct and indirect effects are expected on the EU supply
chain. The imposition of new requirements that exporters in third countries may
be unwilling or unable to satisfy poses a risk of causing interruption to
trade, especially for packages that cover clone offspring and descendants, and
food products. These trade-mediated effects could negatively impact the EU’s
animal breeding at one end of the supply chain, and affect choice and price of
food for consumers at the other. Some packages are also expected to cause a
large number of businesses to spend time (and thus incur cost) understanding
the implications of the new legislation for their operations, even in
circumstances where they would not be expected to encounter any animals or
products regulated (under that legislation). This is a form of additional
deadweight cost.
 
By making products derived from
clones, clone offspring and clone descendants more ‘visible’, the interventions
are likely to reinforce a drive towards exclusions of such animals and products
from the supply chain. Labelling requirements, which makes clone status visible
to consumers, are likely to further reduce demand for livestock animals
produced from the use of cloning technology and their introduction into the EU
supply chain. Mandatory ‘positive’ labelling is likely to result in downward
pressure on upstream operators by retailers and manufacturers to exclude
clones, their offspring and descendants from the supply chain. Operators will
face additional costs to take measure to exclude these animals. 
Fully segregated supply chains are
feasible in some cases, such as for milk, but due to the lack of market demand
for products formally recognised as being derived from clones (or clone
offspring / descendants), operators are unlikely to invest in those operations.
Direct burdens 
The direct burdens on EU operators
will vary significantly depending on the approach taken, the information
requirements of the approach and the compliance, reporting and enforcement
strategy of competent authorities (sections 7.4 and 8.4). 
‘Learning costs’ 
‘Learning costs’ are the staff time
and advisory costs incurred by directly affected operators as they familiarise
themselves with the new legal requirements (sections 7.4.2 and 8.4.2). Under
the suspension and traceability (Strategy 1) approaches such costs are likely
to be modest where packages focus on breeders and the ‘upstream’ parts of the supply
chain operators (estimated at less than a €100,000 for packages S-A and T-A due
to the small number of directly affected operators, and approximately €1
million for packages S-B to S-D and T-B to T-D). Most of the costs under these
packages are borne by the AI industry. 
Learning costs increase
significantly where packages include regulation of food products. Under the
suspension packages (S-F to S-G) meat food importers will also be directly
affected, increasing costs by more than €5 million. Under traceability packages
(T-E to T-G) costs could increase by approximately €200 million under each
package as other ‘downstream’ operators in the EU supply chain
(slaughterhouses, markets, food importers, processors, manufacturers,
wholesalers, and retailers) are required to learn about the new requirements
(Table 7.5 and Table 8.9). 
Learning costs for breeders /
holdings can vary from relatively modest (a couple of million euro) where
packages focus only on identification and traceability of clones themselves to
hundreds of millions of euro where all holdings must learn about new
requirements related to traceability under Strategy 1 if all animals/batches of
animals must be identified as a clone (or not) and under Strategy 2 if all
individual animals must be identified and traced. This is because the scope of
the regulation changes from focusing only on those operators handling animals
that may be clones, offspring or descendants to all operators raising livestock
animals in the EU. Even if each of these operators only needs a minimal amount
of time to learn about the new requirements, there are nearly eight million
operators that may be directly affected under these scenarios.
Reporting and inspection costs 
Reporting and inspection costs are
incurred as breeders, livestock producers and food business operators responses
to requests for information (i.e. reporting) and/or inspections from competent
authorities (CAs) (sections 7.4.2 and 8.4.3). 
CAs’ approach to regulation will
determine the precise burdens on operators. If CAs take a risk-based approach
that focuses on EU organisations capable of conducting cloning and targeted
checks on imports, then regulatory costs can be reduced. If CAs implement a
comprehensive monitoring and reporting framework then the costs will be far
higher. In all cases, the costs increase as the packages involve more of the
supply chain, and particularly for those that cover food products. 
Annual reporting burdens under the
suspension approach and (the less ambitious, Strategy 1) traceability approach
will be modest where packages focus on clones. For example, traceability costs
are estimated at approximately €2,000 per year for packages focusing on clones
(T-A and T-E). Estimated annual reporting burdens grow to approximately €32,000
under traceability packages that cover clone offspring and clone descendants
(packages T-B, T-C, T-D, T-F, T-G) (Table 7.7 and Table 8.13). Additional
annual reporting burdens could be zero to negligible for breeders/holdings
under traceability Strategy 1 where positive ID is required only for clones,
their offspring and descendants (sub-strategy (a)) but more than €100 million
per year if all animals require individual identification where this is not
already a requirement under EU legislation (Strategy 2) (Table 8.15). 
Compliance costs 
The traceability approach will
impose additional costs on competent authorities and businesses, including
livestock producers. The costs to CAs include one-off costs for changing
paper-based documentary and IT based traceability systems to achieve compliance
with the new rules and on-going costs for operation of the expanded system
(section 8.4.4). 
If the traceability approach focused
on making best use of existing traceability infrastructure (Strategy 1)
consultations with selected MS representatives suggest that these changes could
be made through minor adjustments to existing systems. Sub-strategy (a)
requires identification only of clones, their offspring, descendants,
reproductive materials and derived food products, which would also keep costs
low given the small number of animals in the system. Sub-strategy (b) would
impose much higher costs since it would require an indication of the status of
all animals or batches of animals, and derived products (i.e. clone, offspring,
descendant ‘yes’ or ‘no’). 
If each animal had to be individually identified for all
species without derogations (Strategy 2) much larger investments in databases
and associated systems would be required. Countries with large populations of
porcine, ovine and caprine animals would need to have systems that could
accommodate individual ID of all of these animals (potentially millions of
additional animals and many millions of animal movements). New systems are
likely to be needed to record this information. The costs of adjusting or
creating new systems under Strategy 2 would likely run into millions of euros
in total across the EU. 
There would also be large additional capital and
operating expenses for the livestock sector to work to the new system in which
individual animal ID and traceability is required. That change would involve
removing the derogations put in place under current traceability legislation.
There would be additional costs in acquiring and maintaining equipment (such as
ear tags, and modifying readers). The requirement to identify the clone status
of each small ruminant would require more than 50 million animals to be tagged
each year at a cost to breeders and producers in tags and other equipment
estimated at €37million to €98 million/year. The cost for porcine animals would
be higher because many more porcine animals are produced each year
(approximately 260 million) than ovine/caprine animals (approximately 89
million), and most are currently batch-identified. The cost is estimated at
between €193 and €510 million each year (section 8.4.4.3). Added to this would
be the cost of time taken by operators to administer the system. The inputs
required for an accurate estimation of additional costs are not all available
but the incremental cost of recording clone status on an individual animal
basis is estimated at €24 million for ovine and caprine animals and €71m/year
for porcine animals (Table 8.20). 
The suspension approach would not impose additional
compliance costs on the EU. But it would require compliance expenditure by
third countries that would be required to develop segregated supply chains or
traceability systems sufficient to demonstrate that their exports to the EU of
animals were not clones, their offspring or descendants, and exports of
reproductive materials and food products were not derived from such animals,
much as would be needed under the traceability approach (section 7.4.1). These
systems do not exist at present. 
The labelling and premarket approval approaches would
impose further compliance costs on operators and competent authorities. These
include: 
■ Costs for labelling changes: operators that need
to adapt or redesign product labels in order to accommodate new labelling
requirements will incur additional costs that are expected to range from as
little as €100 to as much as €13,000 per stock keeping unit depending on the
requirements (Table 9.3). The incremental costs will be lower where changes can
be integrated into the labelling ‘lifecycle’ and included during the regular
‘refresh’ of a product label. 
■ Costs for premarket approval: the expected costs
to industry of approvals are less than €30,000 per product for a purely
administrative approval mechanism. Toxicological tests are unlikely to be
required, but if they were, the costs could be more than €300,000 for testing
and detailed risk assessment (section 10.4.2). The designated authority will
also incur costs to establish the approval system. The assumptions made about
evidence required are illustrative for this appraisal only. 
The total expected costs on the supply chain are small
because it is expected that relatively few products would be labelled or
brought to the market. The detail of the labelling requirements (e.g. whether
they specify a note in the list of ingredients or a prominent front of pack
label) would influence impacts. 
In a scenario where imported foods were required to be
labelled as potentially derived from clones, clone offspring or clone
descendants (i.e. “may contain”), there would be impacts on exporters in third
countries. This route would however enable food imports to continue in
circumstances where third countries are unable (or unwilling) to establish
robust traceability systems for such animals and derived products.
Trade-mediated effects 
Many of the measures assessed risk disrupting EU import
trades, with the potential for impacts across the supply chain, from the
artificial insemination and elite breeding sectors all the way through to
consumers. Imports of reproductive materials are of direct importance to the EU
breeding and livestock production sector and benefit the rest of the supply
chain indirectly. If the EU imposes conditions relating to clone status that
exporters are unable or unwilling to satisfy, €3.67 billion worth of annual
imports of meat and other animal-derived food products are at risk of
interruption (sections 7.5.3 and 8.5.2). Given the international trade in
reproductive materials, animals and food, to achieve traceability or exclusion
of products of clone offspring and descendants from the EU supply chain would
demand that the other trading partners of the EU’s direct trading partners have
adequate traceability systems for clone status – in effect a global
traceability system. The feasibility and reliability of such a system is in
doubt. 
The size of such trade-mediated contingent risks varies
depending on the scope of the legislation. The precise impacts will also depend
on the behavioural responses by the EU supply chain and by actors in third countries.
The analysis has therefore estimated trade and jobs ‘at risk’ rather than
specifying definitive losses. The value of trades and the number of businesses
at risk are set out in Table E.1. Both short-run effects (e.g. loss of access
to South American beef) and long-run effects (e.g. impacts on EU dairy breeding
strategies and productivity if EU breeders are denied access to elite genetic
materials from North America) are anticipated. 
EU requirements to trace or excludes products based on a
clone status add cost and complexity for operators exporting to the EU and for
EU importers. Evidential requirements under all scenarios are expected to be
harder to meet, and therefore entail additional costs. 
Premarket approvals (PMAs) could also create issues for
importers of meat and other products into the EU if importers cannot be sure
that imported products are free of animal clones, offspring and descendants
because they will not be able to place them on the EU market. PMA requirements
risk triggering trade disruptions to meat and other animal product imports.
Generic authorisations could reduce the problem. Even under a generic system,
issue remains until the first authorisation is granted Authorities could
provide for a transitional period for PMA to allow food products that may be
derived from clone offspring and descendants to continue to enter the market
without approval until end of the transition period. A PMA requirement would
create an additional barrier for exporters to the EU over and above that posed
by traceability requirements.
Impacts on competitiveness 
In addition to direct economic
impacts and indirect trade-related effects on EU and third country operators
and competent authorities, there may be impacts arising from the proposed
approaches related to competitiveness, including cost competitiveness, capacity
to innovate and international competitiveness. These are each considered in
turn below. 
Table 1: Summary of potential
trade-mediated impacts arising from suspension and traceability approaches
 Issue || Package || Number of businesses at risk || Value of trade at risk (€m/yr) || Significance of impacts if full cessation of trade 
 Cloning technique is unavailable in EU || All suspension packages (S-A to S-G) || LOW – no known food-related companies conducting cloning in the EU || N/A || LOW – potential limited impact to 2020 in the dairy sector 
 Imports of live animals cease || All suspension and traceability packages (S-A to S-G and T-A to T-G) || LOW - small numbers of live animals imported || LOW - 2.3 || MEDIUM – small numbers of animals, but important to EU breeding sector 
 Imports of reproductive materials cease || S-B to S-G and T-B to T-G || MEDIUM – 120 companies may go out of business; 294 AI companies may be affected || MEDIUM - 14 || MEDIUM - HIGH The EU breeding industry is heavily reliant on imported reproductive materials, especially for bovine animals 
 Imports of food products cease || S-F, S-G and T-F, T-G[109] || MEDIUM – 715 companies may go out of business; effects greatest for bovine, ovine and equine meat importers || HIGH - 3,667 || LOW – caprine food imports MEDIUM – porcine, ovine and equine food imports HIGH – bovine food imports 
Cost competitiveness
Packages that extend beyond control of
cloning are expected to have negative impacts on the cost competitiveness of EU
businesses. It is not clear that EU controls on use of cloning would confer an
advantage in export markets that would help to offset the additional costs. In
the EU domestic market the negative impacts of the additional administrative
burdens would be mitigated by an increase in demand for domestically production
if access to imports was reduced.  
The largest direct cost impact domestic
producers is triggered by a requirement for individual animal traceability in
the porcine and ovine/caprine sectors; many producers in those sectors already
exist on low margins and it is unlikely that the incremental costs could be
passed in full down the supply chain.  The packages that impose additional
traceability and reporting burdens would make these sectors less competitive.
Indirect effects may be greater than the direct effects, particularly where
trade losses occur due to third countries not being able or willing to meet
traceability requirements. If trades are halted, input costs could rise in the
EU, for example, in the breeding sector.
 Packages || Direct effects || Indirect effects 
 Control of cloning and use of clone reproductive materials S-A, S-B & T-A, T-B || None as no commercial cloning expected in the EU in the baseline (business as usual) scenario || Some additional administrative costs to meet requirements Risk of loss of access to imports of live animals and RM which could raise input costs, if existing private schemes are not recognised and extended 
 Controls on clone offspring and descendants S-C, S-D & T-C, T-D || Negative impacts on farmers and importers of animal genetics for bovine species Where all animals require ID, significant additional administration and equipment costs in porcine and ovine/caprine sector would negatively impact cost competitiveness of these sectors || Potential trade losses where third countries do not meet traceability requirements to allow importers to meet requirements of suspension or traceability approach in the EU –could raise input costs in the EU 
 Controls on food S-F, S-G & T-F, T-G || Increased compliance and reporting costs || Risk of widely distributed negative impacts due to loss of imports Some negative impacts may be offset if imports are restricted from third countries due to lack of compliance with traceability requirements and EU producers benefit from loss of competition 
Impacts on EU’s capacity to innovate
The indirect (and uncertain) trade-mediated
effects have the potential to immediately impact on innovation and thus
productivity growth in the livestock sector in the EU, particularly for
bovines. If trading partners cut off trade with the EU in live animals and
reproductive materials, it would also affect Europe’s access to high quality
genetics in key breeds and thus the sector’s ability to improve the quality of
the EU breeding stock. Suspension measures which prohibit use of cloning
technologies risk inhibiting the EU’s capacity to innovate in this area, though
the short-term impacts of the approach on cloning research and innovation are
expected to be small.  
International competitiveness
Traceability and suspension packages that
reach beyond regulation of clones and clone reproductive materials risk having
a negative impact on the EU’s international competitiveness. Packages that
result in lack of access to high quality genetic materials from third countries
could, especially over the longer term, negatively impact on competitiveness in
price-sensitive export markets. The additional administrative burden imposed on
the food chain would be expected to reduce the competitiveness of the affected
sectors.  This is particularly true of the more ambitious traceability strategy
which could have negative impacts for porcine, ovine, caprine and equine animal
industries due to significantly higher costs imposed on operators.
There would potentially be some benefits
for EU domestic producers in-so-far as:
■      Packages
that interrupt imports could reduce domestic producers’ exposure to competition
in the EU market, which could improve their competiveness in the domestic EU
market; 
■      Suspension,
traceability, and labelling approaches that enable ‘clone free’ status for EU
products, could have a positive impact on demand for those products in third
countries if this is seen as a premium attribute by consumers; and
■      Competitiveness
impacts arising from the labelling and premarket approval approaches are
expected to flow predominantly from the traceability systems underlying them. 
Impacts on SMEs
The four approaches as specified do not
provide an exclusion from the requirements for SME businesses. The food chain
contains large numbers of SMEs, from the farming sector through to
manufacturing and retail. All four approaches therefore have the potential to
impact on SME growth. The impacts on SMEs are likely to vary depending on the
approach and strategy chosen, as well as information requirements. Indicative
likely impacts are described in Table E.3.
 Package || Sectors || Principal impacts expected || Comments || Significance 
 Control of cloning S-A & T-A || Live animal importers || Risk of loss of market in live animal imports || Aggregate value of trade is small Few businesses rely on trade in live animals to the EU, but important to those few businesses Animals are high-value and therefore likely to be traceable with modest effort || High for affected businesses Low overall 
 Clones plus clone reproductive materials S-B || Importers of RM || Materials will need to be identified as derived from clones and excluded (S-B) from EU market || Existing system can and does already screen out clone RM where required || Low 
 Clones plus clone reproductive materials T-B || Importers of RM || Materials will need to be identified as derived from clones and traced in EU market || Materials are already traceable and identifiable in major exporting countries as derived from a clone || Low 
 As above plus offspring and descendants S-C, S-D & T-C, T-D || Importers of RM || Risk of loss of access to imported RM leads to loss of business for importers where exporters cannot or will not identify RM from clone offspring/ descendants || Existing ‘screening’ system does not extend to offspring and descendants of clones || High 
   || Breeders || Loss of access to high quality Holstein/other genetics would negatively affect breeding programmes || Some Member States are heavily dependent on AI and imported RM for breeding programmes || High in select MS Low in other MS 
 As above, plus food S-E, S-F, S-G & T-E, T-F, T-G || Food importers, processors,  manufacturers, retailers etc. || Risk of loss of access to imported meat and dairy suppliers Import substitution from domestic supply should raise prices/profitability for EU suppliers || Higher input prices likely Some businesses rely entirely on imports Food products derived from clones (T-E) are highly unlikely and could be excluded through pragmatic measures without the negative impacts expected from T-F and T-G. || High/critical for businesses dependent on imports General negative impact from higher input prices 
Social
(employment) impacts
Few EU jobs are currently sustained by
commercial livestock cloning so suspension will have little direct impact on
employment in the breeding sector. The more substantial employment impacts
expected are:
■     
Employment
losses prompted by the additional administrative burdens place on livestock
producers and other food business operators (FBOs); and
■     
The
risk to jobs in EU livestock sector and supply chains created by requiring
third countries to comply with traceability conditions that they may be unable
or unwilling to meet. 
Direct and indirect (trade-mediated)
employment impacts of the suspension and traceability approaches, as well as
labelling and premarket approvals are summarised in Table E.4.
Impacts
on consumers
The suspension and traceability approaches
that reach beyond control of cloning and clone reproductive materials could
result in negative impacts on EU consumers. These may include both price
effects (i.e. price changes in consumer markets) and choice effects (i.e.
changes in the availability of goods and services available to consumers).
Short run impacts are likely to be highest for packages that include food
products, mainly because of the potential trade-related impacts on food
imports. These could limit the availability of certain products and increase
prices where alternatives must be sourced from other trading partners or
supplemented by domestic production. Traceability Strategy 2 may also increase the
production costs for operators, and these costs may be passed to consumers,
increasing costs to purchase these products.
   || Direct impacts || Indirect (trade-mediated impacts) 
 Suspension || Negligible for all packages – few if any EU jobs sustained by commercial cloning in the food chain || Potential high negative impacts; suspension puts jobs at risk in businesses importing products and in downstream supply chains – impacts expected in the EU and third countries, especially for packages related to food products (S-E, S-F, S-G) 
 Traceability – Strategy 1 || Negligible for live clones (T-A) and their reproductive materials (T-B) – few EU jobs sustained by commercial cloning; reproductive materials are already traceable and the status of the RM is easy to determine || May have negative impacts for domestic and third country operators for reproductive materials from clone offspring (T-C) and descendants (T-D) – third countries unlikely to implement required systems to enable traceability. Packages related to food products (T-E to T-G) could produce significant employment impacts in sectors currently sustaining thousands of jobs in the EU and third countries if traceability requirements results in a cut-off in trade of these products 
 Traceability – Strategy 2 || Direct impacts for live bovine animals, and RM of all species (T-A, T-B) expected to be the same as under Strategy 1 EU jobs would be created for live porcine, ovine, caprine and equine animals to produce tags, equipment, computer systems for individual ID and to implement the systems (T-A, T-C, T-D) || Impacts for food products of all species (T-E to T-G) expected to be the same as under Strategy 1. Employment gains through expanded traceability for porcine, ovine, caprine and equine animals likely to be offset by employment losses caused by additional administrative burdens place on livestock sectors and supply chain. 
 Labelling || Few products likely to be brought to market under ‘positive’ labelling Voluntary labelling may result in creation of a small number of jobs in administration of requirements, inspections, etc. || Impacts are expected to be related to the underlying traceability systems, rather than labelling itself 
 Premarket approval || No measurable employment impacts expected – demand for approvals likely to be zero || Primary impacts are expected to be related to traceability rather than the PMA itself; though PMA would present an additional barrier to trade if / once the traceability issues had been overcome. 
 Package || Price effects || Choice effects 
 S-A, S-B & T-A, T-B (Strategy 1, positive ID only) || None expected || None expected 
 S-C, S-D & T-C, T-D (Strategy 1, positive ID only) || Price effects in dairy markets if dairy sector loses access to imported reproductive materials Marked short run effects may occur in MS with high dependence on imported RM and heavy use of AI Price effects in meat and meat products sector if meat production sector loses access to imported RM || Limited, except as a consequence of product scarcity 
 T-A, T-C, T-D (Strategy 1 and 2, ID all animals/batches) || Negative price effects if all animals must be identified || None expected 
 S-F, S-G and T-F, T-G (Strategy 1 and 2) || Price effects in dairy markets if imports of dairy products cease Potentially significant price effects in meat and meat products sector if imported meat products cease (primarily bovine, as well as ovine meats) || Product-specific and seasonal due to loss of access to specific brands/types of dairy product. Significant for bovine meat and meat products Significant for ovine and caprine meat products Limited for porcine and equine meat products 
Environmental impacts
The evidence suggests that the negative
welfare impacts are concentrated in the cloning process itself. The incremental
animal welfare benefits are thus highest for the measures and packages that
focus only on cloning (measure S1, package S-A; measure T1, package T-A).   As
the scope of the packages increases to cover offspring, descendants and food,
the additional animal welfare benefits decline while the additional economic
impacts, and risks, increase.
There is uncertainty about the impacts of use of cloning on genetic
diversity in domesticated species, but the most likely outcome is a reduction
in the genetic diversity of the gene pool, and potentially further
concentration in the use of a small number of breeds. The EU’s exposure to
these impacts is likely to be indirect, mediated through the use of genetic
materials imported from North America. Regulating the use of cloning could
reduce the risk of this loss of diversity, though it could also deny EU
breeders access to high quality genetics from North America that are used to
supplement ‘domestic’ genetics. If, in extremis, imports of reproductive
materials ceased then EU breeders in the dairy sector and elsewhere would be
denied access to the global ‘pool’ of genetic resources used in animal breeding
and would need to develop alternative strategies for the same breeds or turn to
other domestic EU breeds. 
Conclusion
The analysis
suggests that controls that were limited to the use of cloning in the EU in the
period to 2020 would not have a significant economic impact, partly because
little or no commercial cloning is expected even without regulation. 
Suspension of, or requiring traceability for, clone reproductive materials is
feasible and would not have a large economic impact if existing supply chain
arrangements can be recognised, formalised and extended. However, as the scope
of the packages increases beyond cloning to cover offspring, descendants and
food, the incremental animal welfare benefits decline while the additional
economic impacts, and risks, increase. Packages also become progressively less
feasible. The key issues are:
■      The
costs associated with traceability requirements imposed on the EU supply chain
under the traceability approach, and the exact specification of those
traceability requirements;
■      The
systems or documentary evidence that entities exporting animals, reproductive
materials and to the EU will be required to have to support declarations on
whether those goods are clones, clone offspring and clone descendants, or
derived from such animals; and
■      How
to foster a system that is robust and reliable in a context where claims of the
clone status of animals and products will not (with few exceptions) be
verifiable except by documentary evidence, where mistakes as to parentage are
easily made (e.g. through mixing of young animals and parents in extensive
systems), and where incentives in the supply chain may not encourage compliance
(e.g. higher costs, lower market value).
The proportionality of the actions
represented by many of the packages evaluated is doubtful given the absence of
commercial cloning in the EU and that commercial cloning for food production in
third countries is largely confined to bovine animals.

Annex VI: Summary of EU requirements on the identification and
traceability of life animals and reproductive material and novel food

1. Live animals
a) For Bovine animals, the main objectives of the current system of identification,
registration and traceability are to identify individually and to trace
animals for the control of infectious diseases and  to re-establish consumer
confidence in beef and beef products through transparency and traceability of
bovine animals and the meat derived.
The system is based on 4 elements: “double ear
tag”, “holding register”, “cattle passport” and “national computerised
database”. The identification is individual and the registration of individual
movements is compulsory by keepers in the holding register and in the database.
The holding register and the database contain among others information on the
date of birth and the mother of each bovine animal.
In the case of imported live bovines, EU legislation
ensures identification on the animal in question upon arrival and subsequent
tracing once the bovine enters the EU. Information about parentage and date of
birth is not requested in the import health certificate. However the whole
pedigree (parents and grand parents) is provided in the zootechnical
certificate for pure bred animals which are  intered to be registered in herd
books. The total number of live bovine imported into the EU is limited but
these are mainly pure bred animals with zootechnical certificates.
b) For sheep and goats, the objective is
mainly animal health. Sheep and goats born after 1 January 2010 must either be i)
individually identified with an electronic identifier and an eartag or ii) by
two conventional eartags. National computerized databases have been set up also
for ovine and caprine but only holdings have to be registered. The registration
of individual animals and their movements has only to be done in the holding
registers and not in the database. The holding register and the database do not
contain information on the parentage 
It has to be noted that the current legislation on small ruminant
identification provides for a derogation to individual identification for
slaughter animals under 12 months old under certain conditions. 
In
relation to imports of sheep and goats from third countries, the current import
health certificate does not impose to record information on the parentage, but the whole pedigree (parents and grand
parents) is provided in the zootechnical certificate for pure bred animals.
The number of live sheep imported into the EU is limited. 
c) For Pigs, the objective is mainly animal health. The current system for
identification in the EU is less sophisticated than the system set up for
bovine, ovine, caprine and equine since it is not based on individual
identification but on "batch/holding" identification which enables to
determine the last holding from which they come from and the holding on which
they were born. Each animal is identified at birth with the identification
number which is attributed to the farm of birth and keeps it up to slaughtering.
The same animals receive a second eartag from the farm of fattening (same
number attributed to the whole batch of production). All farms are registered
in the national database of porcine holdings. 
The database does not contain records of animal movements but all
holdings have to register in their holding registers the information related to
animal movements between holdings (including slaughterhouses) based on batches
of animals. The traceability of batches of animals is therefore paper based
(holdings registers and possible documents accompanying the movements of
animals). 
In
relation to imports of pigs from third countries, the current import health
certificate does not impose information on the parentage
but the whole pedigree (parents and grand parents) is provided in the
zootechnical certificate for pure bred animals. The number of live pigs
imported into the EU is limited (around 800 per year).
d) For
Equine animals, the objective is mainly animal
health. Horses born after 1 January 2009 must be individually identified
(electronically) but the registration of individual movements is not done in
the database. The current system for identification is based on a single
lifetime identification document (individual passport) and the registration of
individual animals in a database. The database is updated only following to a
change in the ownership of the animal. The microchip contains the Unique Equine
Life Number (UELN), and the microchip number can be linked to a central
database and/or to the passport.
In relation to
imports of horses from third countries, the current import health certificate
does not impose information on the parentage but the
whole pedigree (parents and grand parents) is provided in the zootechnical
certificate for pure bred animals. The number of horses imported is
around 10000 horses per year, but most of them are not intended for the food
chain.
For all species, the responsibility to
register and to feed the system with information related to animal movements, births,
deaths, etc. falls on the keeper of the animal. EU legislation describes
clearly the information to be recorded per every animal, which varies depending
on the animal species. This includes information on the mother but only for
bovines. Information on the father is not requested for any of the farm animal
species.
Table 1: Main EU legislation and type of
identification and traceability by species
 Species EU Legislation || Identification || Traceability (Registration of animals) 
 Bovine Regulation 1760/2000 || Individual (Ear tag) || Individual + passport National Database 
 Ovine/caprine Regulation 21/2004 || Individual (EID or ear tag) || Individual / holding register Batch (Lambs) (Holding register) 
 Porcine Directive 2008/71 || Batch (Ear tag) || Batch holding register 
 Equine Regulation 504/2008 || Individual (EID) || Individual + passport National Database or passport 
2. Reproductive material 
Health certificates are
required for intra-community trade and imports of reproductive material.
Current rules on trade of either EU produced or imported semen and embryo
establish a registration system which is based on the individual identification
of the donor (semen) or both donors (for embryo). That system ensures that
these reproductive materials can only be marketed if the individual
identification of the donor animal(s) is indicated on the straws, ampoules or
other packaging, containing the individual dose of semen or embryos and on the
veterinary import certificate accompanying these products. This information
then allows the traceability of these reproductive materials from the breeding centre
of production up to the farm of destination.
a)
Intra-community trade
·        
Information in the health certificate contains
provisions related to identification and registration of the donor animal(s).
For each consignment of semen: approval number(s) of semen centre(s), identity
of the donor animal(s), identification mark(s) of doses and the consignee(s).
Similar rules for embryo.
·        
This information is transferred electronically
via TRACES.
·        
Traceability requirements provides for an unique
identification number of donor animal(s) which is labelled (bar code) for
each semen straw / embryo ensuring full traceability from the donor animal to
the farm(s) of destination.
b) Imports
from third countries
·        
Equivalent requirements on identification and
registration apply for imports of reproductive material from third countries
than to those for intra-EU trade
·        
Only EU agreed collect and storage semen centres
can provide semen to the EU market.
c) National trade
·        
No health certificate and therefore no
registration are needed for national trade of reproductive materials. 
·        
However EU Law foresees that semen centres have
the obligation to register the consignee (approved entities of destination) for
each semen consignment they put on the market.
3. Registration of zootechnical
certificates for trade of live animals and reproductive material (pure bred
only).
As regards farmers willing to register
their pure bred animals in herd books: on top of the above-mentioned
requirements on identification and registration, pure bred animals must comply
with additional requirements resulting of the provisions contained in the EU zootechnical
legislation. This includes the possibility to have additional information on
the parentage of these animals via the herd-books, like registration of both
parents and the 4 grand-parents. This information is managed by private
organisations and on a voluntary basis. The number of farm animals for which
this additional information on identification and registration could be
available represents a small percentage of the total animal farm population in
the EU. 
a) Imports from third countries
Imports of reproductive material and pure
breed animals from third country may on the top of the identification and
registration requirements referred in points 1 and 2, comply with additional
requirements resulting of the provisions contained in the zootechnical
legislation. EU zootechnical certificates[110]
are not systematic for the imports of pure bred live animals and their
reproductive material as it depends if the farmer of destination intends to
register the animal(s) imported or obtained in the national herd-book of the
breed.
b) Intra-community trade
·        
Member States may also impose EU
genealogic/zootechnical certificates[111]
(delivered by herd-books) for pure breed animals and pure breed reproductive
material intended for intra-community trade.
·        
These certificates provide information on the
pedigree (see paragraph 1 b) for registration in the national herd-book of the
breed of i) pure bred live animals and ii) the offspring obtained from their
reproductive materials.
4. Traceability of food
Food traceability is the ability to track any
food, food producing animal or substance that may be destined for human consumption
through all stages of production, processing and distribution of foods. For the
proper application and enforcement of origin labelling, an effective
traceability system is required to ensure the passing of the origin information
along the food chain. 
a) General EU
traceability requirements.
The EU traceability legislation aims at
ensuring food safety. Accordingly, 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[112] sets out a
comprehensive system of traceability within food and feed businesses to meet
this objective.  The traceability requirements can be
summarised as follows:[113]
v  The traceability of food, feed, food-producing animals, and any
other substance intended to be, or expected to be, incorporated into a food or
feed should be established at all stages of production, processing and distribution.
v  FBOs must be able to identify any person from whom they have been
supplied with a food, a feed, a food-producing animal, or any substance
intended to be, or expected to be, incorporated into a food or feed. To this
end, FBOs must have in place systems and procedures that allow for this
information to be made available to the competent authorities on demand.
v  FBOs must have in place systems and procedures to identify the other
businesses to which their products have been supplied. This information must be
made available to the competent authorities on demand.
v  Food or feed which is placed on the market or is likely to be placed
on the market in the Union must be adequately labelled or identified to
facilitate its traceability, through relevant documentation or information in
accordance with the relevant requirements of more specific provisions.
The requirement to identify suppliers and
other businesses to which products are supplied is known as the ‘one step
back - one step forward’ approach. The ‘one step
back - one step forward’ approach implies for food business operators that:

-       
They must have in place a system enabling them
to identify the immediate supplier(s) and immediate customer(s) of their
products;
-       
a link ‘supplier-product’ must be established (which
products supplied from which suppliers); 
-       
a link ‘customer-product’ must be established
(which products supplied to which customers). Nevertheless, food business
operators do not have to identify the immediate customers when they are final
consumers. 
As such, the existing traceability
requirements do not foresee a cumulative traceability system.
The traceability requirements set out in
Regulation (EC) No 178/2002 are worded in terms of their goal and intended
result, rather than in terms of prescribing how that result is to be achieved. This allows certain flexibility to the FBOs in the implementation of
these requirements. 
b) Traceability of food of animal origin.
As far as foods of animal origin are
concerned, Commission Implementing Regulation (EU) No 931/2011 of 19 September 2011 on the traceability
requirements set by Regulation (EC) No 178/2002 of the European Parliament
and of the Council for food of animal origin[114]
sets out additional traceability requirements. In
particular, it applies to unprocessed and processed foods of animal origin.[115]
It requires FBOs to ensure that the following information concerning
consignments of food of animal origin is made available to the FBO to whom the
food is supplied and, upon request, to the competent authority: 
-         
 an accurate description of the food; 
-         
the volume or quantity of the food; 
-         
the name and address of the food business
operator from which the food has been dispatched; 
-         
the name and address of the consignor (owner) if
different from the food business operator from which the food has been
dispatched;
-         
the name and address of the food business
operator to whom the food is dispatched; 
-         
the name and address of the consignee (owner),
if different from the food business operator to whom the food is dispatched; 
-         
a reference identifying the lot, batch or
consignment, as appropriate; and 
-         
the date of dispatch.
These information requirements must be
updated on a daily basis and kept at least available until it can be reasonably
assumed that the food concerned has been consumed.
In addition, Regulation (EC) No 853/2004 of
the European Parliament and of the Council of 29 April 2004 laying down
specific hygiene rules for food of animal origin[116] requires
that products of animal origin should have an identification mark indicating
the last approved establishment in which the product was handled. The
identification mark must indicate the country where the establishment is
located and its approval number. Establishments located within the Union must
be indicated as EC (or equivalent abbreviation in other languages). 
Imports of live animals and animal products
from third countries into the EU are governed by detailed legislation in the
veterinary field. Third countries exporting to the EU must have traceability
systems in place for exports, which are able to provide equivalent standards to
those in the EU. In that respect, Regulation (EC) No 853/2004 sets out general
obligations for the importation of products of animal origin from third
countries, including the fact that foods of animal origin can only be imported
from countries and establishments laid down in EU lists. 
c) Specific
requirements for fresh beef
With regard to bovine animals and fresh beef,
Regulation (EC) No 1760/2000[117]
and Commission Regulation (EC) No 1825/2000[118]
lay down mandatory origin labelling as well as detailed traceability
requirements for bovine animals and fresh, chilled or frozen beef products for
the purposes of food safety, origin labelling and animal health including
disease control. Operators at all stages of production up to the point of sale
must have systems in place to ensure the link between bovine animals, carcasses
and/or cuts of fresh, chilled or frozen beef including minced beef. In that
respect, the following indications must be included on the label of such food
products:
-         
a reference number or code linking the meat to
an animal or group of animals;
-         
the approval numbers of the slaughterhouse and
cutting plant;
-         
the Member State or third country of birth;
-         
the Member State or third country of rearing;
-         
the Member State or third country of slaughter;
-         
the Member State or third country of cutting.
Where meat is derived from animals born,
reared and slaughtered in the same Member State or third country, the
indication may be given as ‘Origin: [name of Member State/third country]’.Where
beef is derived from animals that have been reared for 30 days or less, the
indication of origin should provide:
-         
the Member State or third country of birth, or;
-         
the Member State or third country where
slaughter took place;
Where full information is not available for
beef imported from third countries, it may be permitted to state the country of
origin as ‘non-EU’, provided that the name of the third country of slaughter is
indicated. In this case, live animals must generally have been kept for a
minimum of six months in the designated country before slaughter and export of
the beef into the EU. 
A derogation is allowed for minced meat where
the label must indicate as a minimum ‘Prepared: [name of Member State/third
country]’ to show where the minced meat was prepared; and ‘Origin: [name of
Member State/third country]’ if the meat originated from a country or countries
other than the country of preparation.
Traceability of processed beef meat is
subject to the general requirements of Regulations (EC) No 178/2002 and
931/2011, which do not address the passing of origin information along the food
chain. 
d) Specific
traceability requirements for sheep and goat meat
Council Regulation (EC) No 21/2004[119]
concerns the identification and registration of live sheep and goats to permit
individual traceability throughout their lifetime via electronic identification
for animals born after 1 January 2010, subject to certain derogations. 
The sheep and goat traceability system
enables the complete traceability within the EU of live sheep and goats through
individual electronic identification. Traceability, however, of unprocessed and
processed sheep and goat meat is subject to the general requirements of
Regulations (EC) No 178/2002 and 931/2011, which do not address the passing of
origin information along the food chain. 
In addition, national databases containing
information on individual sheep and goat movements are not compulsory but may
be implemented voluntarily in Member States. The lack of national databases
makes full information on the origin of sheep and goat meat more difficult to
access than in other systems, particularly traceability of unprocessed beef.
e) Specific
traceability requirements for pig meat
Council Directive 2008/71/EC[120]  concerns the
identification and registration of live pigs. Pigs must be identified and
registered in such a way that movements of animals and the farm of origin can
be traced rapidly and accurately. The pig identification system is based on
batch identification and not individual identification. In particular,
Directive 2008/71/EC requires: 
-         
identification marks to be applied before pigs
leave the holding of birth, making it possible to determine the holding of
origin;
-         
animal keepers must keep records of movements of
animals entering and leaving a holding, at least on a batch basis and including
the origin or destination, as applicable;
-         
keepers must supply the competent authority on
request with all information concerning the origin, identification and where
appropriate the destination of animals that they have owned, kept, transported,
marketed or slaughtered;
-         
these procedures apply to intra-Union movements;
and,
-         
pigs imported from third countries must be
similarly identified and a link established and recorded to identify the third
country. Imported animals going direct to a slaughterhouse need not be
re-identified.
The pig identification and recording system
enables identification of the holding and country of birth, and identification
of the last holding from which an animal has come. Intermediate holdings may be
traced through records of movements, although the system does not guarantee the
traceability of all intermediate holdings prior to the last holding for
individual animals. This system of traceability does not allow the passing of
information on origin along the full chain.
Traceability, however, of unprocessed and
processed pig meat is subject to the general requirements of Regulations (EC)
No 178/2002 and 931/2011, which do not address the passing of origin
information along the food chain. In addition, the national databases for pigs
do not contain information on individual movements, making it more difficult to
ensure the full origin information as regards pig meat, compared to the traceability
of unprocessed beef.
5. Novel Food Regulation
The Novel Food Regulation (EC) n° 258/97
covers the food derived from animals which are obtained by non-traditional
breeding techniques and therefore the food from cloned animals. As offspring
and descendants are conventionally bred, their food is not covered by this
Regulation.
Food from clones could only be placed on
the EU market after the submission of an application -by an applicant to the
competent Authorities of a Member State- has gone through a scientific risk
assessment performed at national level and, if objections from member State(s),
at EU level by the EFSA and finally obtained an individual authorisation by the
European Commission. When a Novel Food authorisation is granted, mandatory
labelling can be requested. Once an individual authorisation has been given to
a prior applicant, other applicants can submit an authorisation request for the
same product through a simplified procedure called "notification"
based on the opinion of a national food assessment body that has established
"substantial equivalence" with the novel food already authorised.
Based
on an impact assessment report made in view of the revision of Novel Food
Regulation, the 2008 Novel Food proposal provided for the simplification of
legislation and of the administrative procedures for public Authorities and
food business operators:
- The
procedure for the assessment and authorisation of novel foods is fully
centralised at EU level. National administrative procedures and double risk
assessment -at national and most often at EU level (EFSA)-are repealed.
- The
authorisation procedure is streamlined, increasing its efficiency and reducing
the administrative burden and the length of the authorisation procedure.
-
Individual authorisation currently granted only to the applicant are replaced
by generic authorisations available to all food business operators which comply
with the specifications of the authorisation.
- A
simplified procedure for the placing on the market of the traditional foods
from third countries is introduced to alleviate the administrative burden for
their placing on the EU market.
However, the 2008 legislative proposal was
not adopted in Conciliation in March 2011: a separate legislative proposal on
Novel Food is planned to be adopted at the same time than the legislative
proposal on cloning.
To date no application for authorisation of food from clones has
ever been made. If an authorisation would be requested, it is likely that the
authorisation would include a mandatory labelling of food from clones to ensure
consumer information which implies that the cloned animals and their food will
have to be traced. To date, the identification as such and the traceability of
cloned animals is not in place.

ANNEX VII: Baseline Scenario (Economic)

The scope of activities and sectors which
may be impacted by measures on cloning covers the breeding sector, the farming
sector (meat and milk production) and the food sector, covering five species
(bovine, porcine, ovine/caprine and equine). The baseline is structured as
follows:
A.  EU livestock sector 
B.  The breeding
sector 
C.  Food sector
(including market outlook) 
A. Livestock
sector
1. EU
livestock
Figures on the EU livestock for bovine,
ovine, caprine are provided in table 1:
Table 1: EU livestock population – annual
data – millions of animals) 
 ANIMALS || 2010 || 2011 || 2012 
 Live bovine animals || 87,3 || 86,2 || 85,9 
 Live goats || 13,3 || 12,4 || 8,1 
 Live sheep || 85,9 || 85,6 || 75,8 
 Live swine, || 151,1 || 148,5 || 144,7 
Source: Eurostat 2008
In 2007, EU livestock production accounted
for 41% of agricultural output in value terms, representing 1.2% of the
European Union’s GDP. Highest GDP shares are found in Bulgaria, 4.4%, and
Romania, 3.8%, while lowest shares are found in Luxemburg (0.5%), UK (0.6%) and
Sweden (0.7%). In value terms,
beef and milk represent over 50% of total output, with sheep meat representing
over 20%[121].
However, the relative importance of livestock
production per member states as expressed in the share of the agricultural
output ranges from 28% in the case of Greece to 69% in Ireland, which is
obviously at least partly the result of specific conditions.
Regarding number of actors across the meat
and dairy supply chain, there are almost 8 Million farmers/producers and around
80.000 processors and the same amount of wholesalers and close to 700.000 food
and specialist meat and dairy retailers across Europe.[122]
Dairy farming sector
It remains characterized by an important
diversity and heterogeneity in the EU27, despite strong restructuring, which
expresses itself through labour input, the (feed) resource base and the
intensification and specialization levels including a trend towards landless
livestock production. 
Meat farming sector
The EU produced 7,900
thousand tonnes of bovine meat for the purpose of food production in 2010 among
which 2/3 originate from dairy herds and 1/3 from beef production.
Almost 60% came from four countries (France, Germany, Italy and the UK). The
structure of EU production has changed little over time: the same four
countries accounting for 57% of bovine meat production in 2004. 
Pig production is
generally an intensive, indoor, large scale business which combined with the
much weaker dependence on the local resource base and bio-physical conditions
leads to a relatively low level of variability in production systems.  
Across
the sector, the general trend in production continues to concentrate on fewer,
larger farms. For example, in dairy production where about 50% of dairy cows
are in herds of at least 50 heads and 85% of EU milk production is derived from
high input/output production units. 
Table 2: EU livestock sector’s 2007 – economic
output
 Member || Livestock Production ||   ||   || Share (%) of livestock production(value terms) terms) || 
 state ||   ||   ||   ||   ||   ||   ||   ||   ||   || 
   || Million || Agricultural || GDP ||   || Milk || Beef || Pig || Sheep ||   
   || euro || output share || share ||   ||   ||   || meat || and goats ||   
 fr || 23542 || 36.4% || 1.2% ||   || 31 || 34 || 12 || 3 ||   
 de || 20400 || 45.1% || 0.8% ||   || 47 || 15 || 25 || 0 ||   
 it || 14441 || 33.5% || 0.9% ||   || 30 || 23 || 16 || 2 ||   
 es || 14296 || 36.6% || 1.4% ||   || 19 || 15 || 33 || 11 ||   
 uk || 12301 || 56.8% || 0.6% ||   || 33 || 26 || 9 || 9 ||   
 nl || 9140 || 39.9% || 1.6% ||   || 43 || 18 || 22 || 1 ||   
 pl || 8994 || 45.5% || 2.9% ||   || 35 || 10 || 28 || 0 ||   
 dk || 5449 || 60.2% || 2.4% ||   || 27 || 6 || 44 || 0 ||   
 ro || 4584 || 34.7% || 3.8% ||   || 30 || 11 || 21 || 4 ||   
 Ie || 4092 || 68.5% || 2.1% ||   || 40 || 37 || 7 || 4 ||   
 Be || 3799 || 52.0% || 1.1% ||   || 25 || 27 || 34 || 0 ||   
 At || 2883 || 48.0% || 1.1% ||   || 33 || 29 || 23 || 1 ||   
 Gr || 2881 || 27.9% || 1.3% ||   || 37 || 8 || 9 || 27 ||   
 Pt || 2499 || 37.9% || 1.5% ||   || 30 || 20 || 19 || 5 ||   
 Hu || 2296 || 35.4% || 2.3% ||   || 22 || 5 || 28 || 2 ||   
 Fi || 2259 || 55.2% || 1.3% ||   || 46 || 15 || 15 || 0 ||   
 Se || 2225 || 47.7% || 0.7% ||   || 44 || 18 || 16 || 1 ||   
 Cz || 1763 || 41.6% || 1.4% ||   || 43 || 16 || 23 || 0 ||   
 Bg || 1259 || 41.4% || 4.4% ||   || 39 || 9 || 13 || 13 ||   
 Sk || 941 || 48.9% || 1.7% ||   || 31 || 13 || 21 || 1 ||   
 Lt || 892 || 45.7% || 3.1% ||   || 51 || 16 || 16 || 0 ||   
 Si || 572 || 50.6% || 1.7% ||   || 32 || 29 || 18 || 2 ||   
 Lv || 411 || 43.4% || 2.1% ||   || 49 || 11 || 15 || 1 ||   
 cy || 305 || 50.9% || 2.0% ||   || 28 || 4 || 28 || 11 ||   
 Ee || 303 || 48.2% || 2.0% ||   || 55 || 8 || 22 || 1 ||   
 Lu || 165 || 60.7% || 0.5% ||   || 57 || 30 || 10 || 0 ||   
 Mt || 71 || 59.5% || 1.3% ||   || 24 || 6 || 22 || 1 ||   
 EU-27 || 142190 || 41.4% || 1.2% ||   || 34 || 20 || 21 || 4 ||   
Source:
Eurostat 2008
Meat consumption
Forecasts are mainly driven by increasing
poultry and pork meat consumption, as well as by a firm external demand and
higher prices. On a per capita basis, EU meat consumption[123] in 2022, at 82.6 kg, would be at
approximately the same level as it was in 2009 and 1% lower than in 2011,
despite the improved macroeconomic prospects. Pig meat is expected to remain
the preferred meat in the EU with 40.8 kg/capita consumption in 2022, compared
to 24.1 kg for poultry, 15.7 kg for beef/veal and less than 2.0 kg for sheep
and goat meat.
2. International trade
The EU import trade in live animals for
food production is fairly small except for horses. In 2011, 98% of
the €120m value of live animal imports for the species of interest here related
to horses (generally originating in the US). Most, if not all, of these
animals were destined for sport and leisure uses rather than food
production.
3. Economics
Gross margins in the livestock sector are
generally not high but they are positive. In the EU15 in 2007 farmers
respectively i) breeders or ii) breeder and fatteners obtained on average
comparable Gross Margin -including with EU and national coupled payments- of €310/cow
and €297/cow respectively and an average of €135/male for fatteners (not
directly comparable). The EU-10 margins were lower than the EU-15 for all three
groups, which can be explained in part by the smaller number of cows/cattle per
farm and lower prices for beef. 
However, when looking at economic
performance measured by Economic Profit (also taking into account estimates of
the unpaid family labour) it is negative in most cases. Given the constraints
and incentives, beef producers can be expected to adopt strategies of
minimising production costs, underpaying family factors and subsidising farm
production from decoupled payments and other sources of income[124].
In the meat processing sector, the
concentration process due to very low margins is continuing. For example, in
Germany three slaughterhouses process more than 50% of all pigs. Similarly, in
the retail sector, for the very same reason of decreasing profit margins, the
concentration process is equally increasing with the top four retailers in Germany
providing 65% of the total turnover of the sector.[125] 
B. Breeding sector 
1. Description
The structure of livestock breeding in Europe can be described as a
pyramid with the elite or nucleus breeders at the top, one or more middle tiers
of purebred or crossbred multipliers in the middle, and a final tier of
commercial herds below. Most nucleus breeders and multiplier organisations are
cooperatively owned by farmers, and are often SMEs organised in national
umbrella organisations. For disseminating desired genotypes, these national or
local organisations of farm owners are internationally co-ordinated by a small
number of private, elite breeding companies and cooperatives. 
Important terms are:

 Nucleus herds: elite breeders producing breeding stock, particularly males. 
 Multiplier herds: take improved stock from nucleus herds to create larger
     number of animals for sale to tier below.

- Purebred multipliers produce greater
numbers of purebred animals, particularly males, for sale to the tiers below.
- Crossbred multipliers producing crossbred animals, particularly
females, for use in the commercial tier.

 Commercial
     herds: animals primarily involved in the
     production of milk and meat.  Have little or no involvement in selling
     stock for further breeding.

Table 1: Beef and dairy breeding structure
Most nucleus breeders and multiplier
organisations are cooperatively owned by farmers, and are often SMEs,
operating in their native language, organised in national umbrella
organisations. For disseminating desired genotypes, these national or local
organisations of farm owners are internationally co-ordinated by a small number
of private, elite breeding companies and cooperatives. 
The European Forum of Farm Animal
Breeders (EFFAB) reports that the livestock genetics industry mainly
consists of ‘(small or) medium enterprises or small units in larger
organisations.’ According to one source, the size of livestock breeding
companies tends to be medium scale, with at most 2000 employees, and annual
turnovers not exceeding €0.5 billion[126].
Table 3: Economic operators in the EU by
sector and species (indicative): General overview
 Sector || All species || Bovine || Porcine || Ovine || Caprine || Equine 
 Companies that could conduct cloning activities || 7 || 4 || 1 || 0 || 0 || 2 
 All companies || 294 || 150 || 50 || 10 || 5 || [79 studs] 
Source: Eurostat
2008
AI companies, breeders and producers are
often involved directly in the import of reproductive materials and live
animals. Alongside those making direct use of the imported reproductive
materials, live animals and products, there also exists a number of specialist
import/export trading companies; 
Globally, the
main markets for trade in bovine semen are the EU, the US, Canada and
Latin America. The market value of international trade in livestock
genetics as a whole is relatively small: US and Canadian exports of bovine
semen to the EU from 2006-11 were worth an annual average of €21 million and
€17 million respectively. 
Approximately
99% of bovine semen which is imported into the EU (around 1.9 million
doses in 2011) are sourced from either the US or Canada. The US and Canada are
also dominant in the markets for genetic materials of porcine, ovine, caprine
and equine. A 2008 USDA report indicates that ‘the largest U.S. export in
livestock genetics is bovine semen’[127].
Parts of the EU
livestock sector are now heavily reliant on reproductive materials imported
from outside the EU. For example, while imported bovine semen represents on
average 2.5% of the semen used in artificial insemination in the EU
(considered much higher[128] in some Member States),
the breeding sector considers access to this genetic material as essential to
the continued viability of the industry[129].
On average, the EU exports of bovine are
semen worth €25 million each year[130].
EU exports of bovine semen to the US, Canada and Latin America represent less
than half of this total export value from 2006-2011. A further quarter of this
trade is to neighbouring countries, particularly Turkey and Switzerland, while
more modest amounts are exported to Australia, China and Japan. 
2.
State of play on cloning activity
Taking into
account that no cloning activity is taking place in the EU (see Annex III.1),
it can be estimated that the economic viability of cloning depends mainly on
the cost of a clone and the pregnancy rate: The higher the costs, the more
likely the use of cloning remains restricted to long-use high output animals
(dairy cows, race horses), the lower the costs, the more likely the use of
offspring for short term use (e.g. beef production).
Commercial cloning
activity in third countries is concentrated in a small number of
countries. The countries with the most well-developed commercial cloning
sectors are the US, Canada, and Argentina.  New Zealand, Australia, Chile,
China and Korea are also undertaking commercial cloning for livestock species. 

 Bovine animals: commercial cloning
     activity for livestock is best developed in bovine animals. Cloning
     technology is being applied to cattle in the US, Canada, Argentina and
     Australia[131]
     It may also be undertaken in Brazil, New Zealand, Chile, China and Uruguay
     based on the presence of cattle cloning companies in these countries. 
 Milk and meat from the offspring or
     descendants of cloned bovine animals have entered the food chain in the US
     and may have done so in Argentina; these are the products most likely to
     continue to enter human food chains in the near future. The Swiss
     government says that ‘several hundred’ second or third generation
     descendants of clones are in Switzerland (of a total 1.5 million head of
     cattle);[132]
 Porcine animals: consultations with
     the US cloning industry suggests that there is some commercial cloning for
     pigs in that country and that it is becoming more common. It may also be
     undertaken in New Zealand and China based on the presence of pig cloning
     companies in these countries.
 Ovine and caprine animals:
     consultations[133]
     with industry stakeholders in the EU of third country Competent
     Authorities indicate that commercial cloning of ovine or caprine animals
     outside the EU is uncommon.  Some commercial cloning of these animals is
     on-going in the US, but at very small scale. 
 Equine animals: consultations[134]
     of third country Competent Authorities indicate that there is no livestock
     cloning activity currently being conducted outside the EU for equine animals.
     Sport cloning is being undertaken in North and South America and Brazil
     and South Korea.[135]

Examples of
on-going cloning activities:
·      
TransOva, a US cloning company estimates that it
costs between USD 18,000-20,000 (approximately €15,000-16,000) to produce a
clone. This range is likely to be competitive elsewhere in the world.
Typically, clones are used as breeding animals due to their high cost. A
clone can generate on average USD 60,000 in semen/embryo sales in the first
year of production.
·      
Consultation with EU industry association
COPA-COGEGA indicates that the cost of producing a clone for research
purposes in the EU is approximately €12,000-15,000 (i.e. similar to the
TransOva estimate).  Embryos of cloned bulls sold at auction in the US have
fetched USD 10,000-20,000 (€8,000-16,000), which is the same price as embryos
from an animal from a ‘non-cloned’ high-value embryo line. 
·      
A cloned sport horse can fetch USD
800,000 on the market, based on auction prices in Buenos Aires in 2010 for a
cloned polo horse[136].
Cryozootech, a French horse cloning company sells a dose of semen from a cloned
horse for between €450 and €700 depending on the clone. 
·      
To produce the first cloned fighting bull,
the Spanish breeders group May spent around €30,000. The family which owns the
bull could expect to make around €1.5 million from selling the bulls that the
clone fathers naturally during his lifetime.[137]
C. Food sector
1. General
description
The EU food
sector represents[138] a total turn-over of 1,017 Billion € and approximately 287,000
companies employing 4.25 million people in the EU. Around 98 % companies are
SMEs which represent around 49 % of total turn-over and 63% of employment in
the sector. 
It is the largest manufacturing sector in
terms of turnover, value added and employment. It contributes for around 15 %
of EU gross value added of manufacturing sector. The net trade balance was of
13.2 billion € in 2011 (see table 4 below).
Table 4: EU 27 data on Food and drink
industry (Turnover, Number of employees, Trade)  
   || 2010 || 2011 || 2011/2010(%) 
 Turnover (Euro billion) || 953 || 1.017 || + 6,8 
 Number of employees (million) || 4,25 || 4,25 || 0 
 Exports (Euro billion) || 65,2 || 76,2 || + 16,6 
 Imports (Euro billion) || 55,5 || 63 || + 13,5 
The EU food sector for meat, milk and
derived products is present at three stages of the food supply chain:
The first stage is composed:

 for meat: slaughterhouses, cutting plants (primary and secondary
     cutting) and minced meat plants
 for milk: dairy farms, dairy plants (collect, storage,
     processing and packaging of milk and production of cheese and butter and
     milk industrial ingredients such as caseins).

The second stage is composed:

 for meat: meat processing (meat products), meat industrial
     ingredients (gelatine etc.) and all derived food products where meat is an
     ingredient
 for milk: processed milk products (yogurts, milk based
     specialities) and all food products which contain milk ingredients.

The third stage is composed:

 wholesalers, distributors and food retailers including food
     markets and direct sale at farms.
 caterers (canteens, restaurants etc).

2. Meat and milk sectors
- EU dairy sector
Dairy farming systems remain characterized
by an important diversity, despite strong restructuring (the number of
dairy holdings in the EU15 is now well below the one observed in France in the
beginning of the 1970s), technical modernization and the wide adoption of the
high yield races (Holstein). 
The most striking aspect of the sectors heterogeneity
is the substantial variation in size (surface, herd and quota), from small
units (southern EU but also Austria) to large units (dominant in the UK,
Denmark and the Netherlands). The heterogeneity also expresses itself through
the natural production conditions, labour input, the (feed) resource base and
the intensification and specialization levels and the trend towards
landless livestock production.
The average milk quota per farm also
varies strongly between dairy regions: Less than 160,000 kg in Austria, Spain,
Italy, Finland, Portugal and south Germany (Bayern), milk quotas exceed 400,000
kg in the UK, Denmark, the Netherlands and Eastern Germany. A majority of total
dairy holdings are relatively small in terms of cow numbers and contribution to
total EU production. These farms are probably less specialised than those
accounting for the majority of production with dairying being one of a number
of enterprises (mainly other livestock enterprises) undertaken. However, to
these farms dairying as an activity remains an important part of total economic
activity.
EU dairy production is
very stable, largely as an effect of the milk quota system, but this hides
important trends. Due to the milk quota system, productivity gains in milk
yields lead to a continuing reduction in the total number of dairy cows in the
EU. In general, dairying in the EU continues to intensify and specialize, with
herd sizes of individual farms increasing in all MS.
Together this means that production continues to
concentrate on fewer, larger farms (e.g. about 50% of EU dairy cows are in
herds of at least 50 heads) resulting in a corresponding decrease of dairy
farming on many holdings and in some cases abandonment of holdings. This is
true for virtually all dairy farms irrespective of system or bio-geographical
region; noting that 85% of EU milk production is derived from high
input/output economic/technical class of dairy farming. 
- EU meat sector
The EU produced:
- 7.844 million tons of bovine meat in 2011 (almost 60% came
from France, Germany, Italy and the UK). It originates 2/3 from milk breeds and
1/3 beef breeds.
- 22.011 million tons of porcine meat in 2011 (almost 75 %
came from Germany, Spain, France, Poland, Denmark and Italy).
- 0.732 million tons of sheep meat in 2011 (almost 75% from
U.K., Spain, France and Greece)
- 0.059 million tons of goat meat in 2011 (almost 60% from
Greece).
- 0.053 million tons of horse meat in 2008 (almost 75% from
Italy and Poland).
3. International trade
- Meat sector
The EU exports bovine and pork meat mainly to Russia but also
China, Japan, South Korea and Turkey. The EU is the 2nd biggest
producer of pork meat (after China) and bovine meat (after USA) in the world.
EU is self-sufficient for pork and poultry and has a deficit for bovine (3-4%),
ovine (20-22%) and horse (80%) meat.
- Beef and veal
The EU is a net importer of beef
which is mainly imported from:
- South America (mainly Argentine, Brazil, Uruguay) with a
significant decrease trend.
- USA with significant increase trend following extension of EU
import quota in context of new EU-US agreement on hormone free beef production
for EU (20.000 tonnes). 
Beef imports are forecast to increase. The
trade in beef products could reach half a million tonnes by 2020. Market
effects (e.g. price changes) are more likely to be observed where measures have
an impact on these trade flows. In 2011, approximately 300,000 tonnes of bovine
meat products worth over €1.7 billion were imported into the EU. More than 95%
of these imports came from eight countries. Argentina, Brazil and Uruguay
accounted for approx.70% of total trade volume
In recent years, Australia, New Zealand,
Paraguay, Namibia and the US all increased their bovine product exports to the
EU. By 2011 these five countries together accounted for 27% of total trade (5%
in 2006). 
EU beef and veal imports are forecast to
increase by 10% from 2011 to 2020 according to the latest projections
(OECD-FAO, 2012). Globally, the EU is the third largest importer of beef and
veal behind Russia and Japan.
In total, EU
imports of beef, veal, dairy products and sheep meat are worth € 3.3 billion
per year.
Table 6: Overview annual value of EU
imports
 Species || Product || Approximate Total Annual Value || Summary 
 Bovine || Beef and veal products[139] || € 1.7 billion || The EU is a net importer of bovine meat products and the third largest importer in the world; the net trade imbalance is expected to grow to 2020 
   || Cheese and butter || € 610 million || The EU imports considerable quantities of cheese and butter despite being a net exporter of these products 
 Ovine || Sheep meat || €1 billion || The volume of imported sheep meat is equivalent to over a quarter of domestic EU production; 85 per cent was supplied by New Zealand; the EU is a net importer of sheep meat 
Source based on
COMEXT data
Table 7: Import sector overview: Number of
importers
 Sector || All species || Bovine || Porcine || Ovine || Caprine || Equine 
 Importers: live animals || 1667 || 3 || 12 || 5 || 2 || 1645 
 Importers: meat || 715 || 280 || 40 || 374 (sheep and goat) ||   || 21 
Source: Eurostat
2008
- Porcine meat
The EU is self-sufficient in pig meat and EU porcine
production is stable. The EU consequently imports relatively little
(approximately 15,000 tonnes per year). It accounts for less than 0.1% of
global imports. In 2011, the EU imported just 14,000 tonnes of pig meat, and a
further 18,000 tonnes of offal at a total value of €61 million. 99.9% of pig
offal was imported from Switzerland; over 80% of imported pig meat came from
the US and Chile. The EU also imports relatively high quantities of low value
prepared pig meat such as ham and sausages and offal products; On average the
EU imported 126.000 tonnes of such products at an approximate value of € 18
million per year from 2006-2011.
In addition, the EU also imports gelatine
for EU food, cosmetics and pharmaceutical industries. Total annual EU imports
of gelatine are relatively stable, with 20,000 tonnes imported annually over
the period 2006-11, valuing at approximately €76 million per year. 
- Ovine and caprine meat
The EU is a net importer of ovine and
caprine meat (23% of EU production). Imports from
New Zealand and Australia are the most important trades for ovine and caprine
products. From 2006-2011, EU imports of sheep meat were valued at just over €1
billion per year (averaging 210,000 tonnes per year). Of the total volume
imported into the EU over this period, 85% of total sheep meat imported was
supplied by New Zealand at an average of 178,000 tonnes each year. A further 8%
of EU sheep meat imports were sourced from Australia. Though these figures are
relatively low, it is notable that the volume of imported sheep meat is
equivalent to over 25% of domestic EU production.
Table
8: Overview annual value of EU imports
 Species || Product || Approximate Total Annual Value || Summary 
 Caprine ||   ||   ||   
 Ovine || Sheep meat || €1 billion || The volume of imported sheep meat is equivalent to over a quarter of domestic EU production; 85 per cent was supplied by New Zealand; the EU is a net importer of sheep meat 
Source based on
COMEXT data
- Horse meat
The EU is a net importer of horse meat (50% of EU production). In 2011, the EU imported 28,000 tonnes of
horse meat, valued at €94 million. The volume of imported horse meat is
equivalent to over 50% of domestic EU production. From 2006-2011, the EU
imported a total of €592 million worth of horse meat, 60% of which was sourced
from Latin America (Argentina, Brazil, Uruguay and Mexico) and a further 38%
from Canada and the US.
- Dairy sector
The EU is largely self-sufficient in
dairy products. It is a net exporter but still imports considerable
quantities of cheese from third countries and, to a lesser extent, butter.
These two product groups accounted for almost 90% of the €610 million average
annual value of EU dairy imports from 2006-2011. 
The EU is a major player in international
dairy markets. It accounted for 24-30% of world dairy exports from
2005-2010. The big four dairy producers in order of their market share are New
Zealand, the EU, Australia and the US. Over half of all EU imports of cheese in
2006-11 were purchased from Switzerland, representing 70% per cent of the total
value of EU cheese imports (€1.79 billion).  In this period, a further 150,000
tonnes of cheese worth €348 million were shipped to the EU from New Zealand. In
the same period, New Zealand was also the source of 88% of all EU butter
imports, at the average annual value of €110 million from 2006-2011.
Imports of milk proteins and caseinates
were also significant over this period, with the EU on average importing €178
million each year from 2006-11. Of this total amount, 80% was sourced from just
three countries: New Zealand, Ukraine and Belarus.
4.
Outlook all markets
The EU
meat market is likely to be affected by the on-going economic downturn and
historically high levels of unemployment, which tend to push EU demand towards
cheaper meat options. The new animal welfare requirements in the pig sector are
also expected to play an important role in the near future. As a consequence,
total EU meat production, after having increased during both 2010 and 2011,
will contract by 2% over the next two years.
The OECD-FAO Agricultural Outlook (2011)
forecasts that EU exports in beef and veal will fall steadily year-on-year from
2010 to 2020, dropping by an estimated total of 41% over the period.  EU beef
accounts for only 3% of global beef and veal exports. The marginal role of the
EU in these markets is expected to continue to 2020. Major third country beef
exporters include Australia, Canada, India, the US, and the South American
countries of Brazil, Argentina and Uruguay.  Brazil, Uruguay and Australia are
also major global suppliers of live bovine animals, exporting to the EU’s main
markets in North Africa and the Middle East.
The net trade position of the EU is projected to
deteriorate over the outlook period, driven by an increase in meat imports (of
beef/veal, sheep and goat and poultry meats) and a parallel decline in exports
of poultry. Aggregate meat imports would grow by 5.2% (2022 vs. 2011)
and exports would decline by 6.8%, leaving the EU,
nevertheless, a net exporter of pig and poultry meats in 2022.
The EU milk production is projected to continue
increasing from 2012 onwards, at a moderate growth rate. Aggregate EU
production would remain below the potential growth rate provided by the gradual
elimination of the quota regime. EU milk production is projected to reach 159.3
million tonnes in 2022, accounting for a cumulative increase of 5% since 2011. 

Medium term prospects for milk and dairy products
appear favourable due to the continuing expansion of world demand. Global
population and economic growth, and increasing preference for dairy products
are expected to be the main drivers, fuelling EU exports and sustaining
commodity prices. The best export performance is shown by cheese and SMP, whose
exports over the outlook period would expand by two thirds and triple
respectively.
While the global market situation has
recently been favourable, DG AGRI (2011) reports that expectations for the next
two years depend on the extent of increased milk production both in the EU and
in the main supplying countries (e.g. New Zealand, Australia, and the US) and
the sustainability of strong demand on the world market led by China and other
countries of South-East Asia as well as by the Near and Middle East. 
The OECD-FAO Agricultural Outlook (2011)
projects that global imports of dairy produce will rise by a million tonnes
from 2010 to 2020. Despite this growth in the market the EU’s share of global
dairy products is forecast to fall below 20% in this period. This is largely as
a result of competitive pressure from New Zealand.
From 2009 to 2010, EU bovine exports
increased in volume by 125%. Particularly marked increases occurred in the
trade of fresh, chilled and frozen bovine meats as well as in the trade of live
bovines.  From 2004-2011, the relatively stable EU exports in bovine offal
represented 25% of total bovine meat and meat product exports. As a result of
such rapid growth, the total value of EU exports of live bovines and bovine
meat in 2011 was worth of €1.7 billion. Exports doubled in size in a single calendar
year from 2009 to 2010.
EU porcine export market outlook: pig meat accounted for roughly a quarter of total world pig meat
exports from 2005 to 2010.  Pork exports from the US and Canada accounted for a
further quarter each in this period; Brazil is the fourth largest pork
exporter. 
EU pig meat exports are forecast to decline
year on year to 2020, with the EU seeing its share of the market fall to 20%
(OECD-FAO 2011). This decline is likely to occur in the context of global
growth in the volume of pig meat exports (likely to be sustained by demand in
Japan, Russia, Ukraine and other East Asian markets), which is forecast to be
mostly captured by US pig exporters. There is also growing import demand for
pig meat in markets where EU exports currently have less market presence such
as Mexico, the US and Australia.
Looking ahead for the EU ovine and
caprine export market to 2020, the forecast to increase but still account
for just 2% cent of global sheep meat exports (OECD-FAO 2011).  Australia and
New Zealand together account for over 75% of this trade. The EU is the world’s
biggest importer of sheep meat, taking 25% of global sheep imports in 2010.
Saudi Arabia, the US and China are the next biggest markets for sheep imports.
The volume of EU imports of sheep meat is forecast to decline by 22% from
estimated 2010 levels.[140]
References
Butler, L.J., and Marianne McGarry Wolf (2010).
Economic Analysis of the Impact of Cloning on Improving Dairy Herd Composition.
AgBioForum 13 (2): 194-207.
Carroll, R. (2011) ‘Argentinian polo readies itself
for attack of the clones: Player forms alliance with genetics laboratory to
clone equine champions in hope of replicating performance’, The Guardian, http://www.guardian.co.uk/world/2011/jun/05/argentinian-polo-clones-player.
Dematawewa, C.M.B., & Berger, P.J. (1998).
Break-even cost of cloning in genetic improvement of dairy cattle. Journal of
Dairy Science 81(4): 1136-1147.
Eurostat External Trade Statistics (COMEXT), http://epp.eurostat.ec.europa.eu/newxtweb/
European Commission 2012: "Prospects for
Agricultural Markets and Income in the EU 2012-2020", DG AGRI 12/2012
European Commission 2012: "Report from the
European Commission to the European parliament and the Council "Evolution
of the market situation and the consequent conditions for smoothly phasing-out
the milk quota system - second "soft landing" report COM(2012) 741
final, Brussels, 10.12.2012
Gura (2007) ‘Livestock genetics companies:
Concentration and proprietary strategies of an emerging power in the global
food economy’, League for Pastoral Peoples and Endogenous Livestock
Development.
IFC GHK 2012: Impact in the EU and third countries of
EU measures on animal cloning for food production, 2012
JRC 2010: Evaluation of the livestock sector's
contribution to the EU greenhouse gas emissions (GGELS), Final report 2010
JRC 2013: Contribution to the economic impact
assessment of policy options to regulate animal cloning for food production
with an economic simulation model. JRC Scientific and Policy Report, EUR XXXXX
(forthcoming)
Kanter, J. (2010) ‘Cloned Livestock Gain a
Foothold in Europe’, New York Times, July 29, 2010, available from: http://www.nytimes.com/2010/07/30/business/global/30cloning.html?pagewanted=all.
United States Department of Agriculture
(USDA) (2008), ‘EU-27 Livestock and Products Animal Genetic Markets in EU
Member States 2008’, Foreign Agricultural Service Global Action Information
Network Report.

ANNEX VIII: EU statistics on imports of live animals,
reproductive materials, meat, meat products, milk and milk products (sources
COMEXT[141] and TRACES[142])

Statistics on imports below provide from 2
EU sources (Comext and TRACES) and may differ between the 2 sources. Data of
reference are those from Comext. TRACES data are provided as a complement and
should be considered mainly for the imports of live animals and reproductive
materials.
The discrepancy in the trade volumes
between Eurostat and TRACES data for the products of animal origin is due
to the different methodology applied for the definition of the products group
(meat, milk etc.). The custom code applied for the custom tariff purposes do
not take account the veterinary description of the goods. For example, in case
of the custom code applied for the meat products allows the use of the
added salt, whereas such products under veterinary legislation is categorised
as meat preparations.
In case of  data differences for the
reproductive material, there is no conventional rate of duty applied for the
import and  reproductive material is not presented as unit volume as
straw, but converted as a weight calculated number of straws.  The TRACES
data are recorded by Member State border veterinarian and in such cases as well
different volume measurements have been applied: number of straws,  amount
presented in kilograms, amount presented in ml etc.
I. Live animals
Importations of live bovine in the EU are
very low apart from Turkey in 2011. The EU also imports few bovines in a
sporadic way from various third countries including Canada and USA. 
The same situation occurs for imports of
live ovine and caprine. Imports of live porcine though limited are more
significant and originate mostly from Canada and Russian Federation.
Imports of live horses are more developed
and originate from a large set of countries. On the contrary to other above
species where imported animals are intended for reproduction, live horses are
mainly imported for horse races and leisure activities.
- EU live bovine imports compared to EU livestock
(Source Comext)
 Origin/Year/Nbr. Anim. || 2007 || 2008 || 2009 || 2010 || 2011 
 Turkey || 0 || 0 || 0 || 6 || 18.548 
 Albania || 0 || 0 || 67 || 0 || 0 
 FYROM || 0 || 62 || 0 || 0 || 0 
 Canada || 1 || 0 || 0 || 10 || 42 
 Croatia || 0 || 0 || 14 || 10 || 0 
 United States || 0 || 15 || 0 || 0 || 0 
 Ukraine || 3 || 0 || 0 || 0 || 0 
 Argentina || 2 || 0 || 0 || 0 || 0 
 United Arab Emirates || 0 || 1 || 0 || 0 || 0 
 New Zealand || 0 || 0 || 0 || 0 || 0 
 TOTAL || 6 || 78 || 81 || 26 || 18.590 
 EU live bovines || 89.037.000 || 88.867.000 || 88.300.000 || 87.391.200 || 86.250.200 
 % of imports/EU production || 0.000006 || 0.00008 || 0.00009 || 0.00003 || 0.021 
-
EU live bovine imports (Source TRACES)
 Origin/Year Nbr. Anim. || 2006 || 2007 || 2008 || 2009 || 2010 || 2011 
 Canada || 0 || 0 || 0 || 0 || 10 || 42 
 New Zealand || 0 || 0 || 0 || 0 || 0 || 3 
 TOTAL || 0 || 0 || 0 || 0 || 10 || 45 
 EU live bovines || N/A[143] || 89.037.000 || 88.867.000 || 88.300.000 || 87.391.200 || 86.250.200 
 % of imports/EU production || -- || 0 || 0 || 0 || 0.00001 || 0.00005 
-
EU live ovine imports (Source Comext)
 Origin/Year Nbr. Anim. || 2007 || 2008 || 2009 || 2010 || 2011 
 Turkey || 0 || 0 || 0 || 0 || 25.690 
 Bosnia and Herzegovina || 0 || 631 || 0 || 0 || 0 
 Croatia || 20 || 0 || 0 || 510 || 0 
 New Zealand || 2 || 5 || 0 || 10 || 29 
 Canada || 0 || 0 || 11 || 21 || 0 
 Russian Federation || 0 || 0 || 0 || 0 || 7 
 Iceland || 5 || 0 || 0 || 0 || 0 
 TOTAL || 27 || 636 || 11 || 541 || 25.726 
 EU live ovines (source Eurostat) || 95.803.000 || 90.907.000 || 88.757.000 || 85.945.500 || 85.648.000 
 % of imports/EU production || 0.00002 || 0.0006 || 0.00001 || 0.0006 || 0.03 
-
EU live ovine imports (Source TRACES)
 Origin/Year Nbr. Anim. || 2006 || 2007 || 2008 || 2009 || 2010 || 2011 
 New Zealand || 0 || 2 || 21 || 0 || 22 || 29 
 Croatia || 0 || 0 || 0 || 0 || 510 || 0 
 Canada || 0 || 0 || 0 || 11 || 9 || 0 
 TOTAL || 0 || 2 || 21 || 11 || 541 || 29 
 EU live ovines (source Eurostat) || N/A || 95.803.000 || 90.907.000 || 88.757.000 || 85.945.500 || 85.648.000 
 % of imports/EU production || -- || 0.000002 || 0.00002 || 0.00001 || 0.0006 || 0.00003 
-
EU live caprine imports (source Comext)
 Origin/Year Nbr. Anim. || 2007 || 2008 || 2009 || 2010 || 2011 
 Bosnia and Herzegovina || 0 || 55 || 0 || 0 || 0 
 Chile || 0 || 0 || 0 || 44 || 0 
 Canada || 16 || 0 || 0 || 0 || 0 
 Russian Federation || 0 || 1 || 3 || 0 || 0 
 United States || 0 || 0 || 0 || 0 || 1 
 TOTAL || 16 || 56 || 3 || 44 || 1 
 EU live caprine (source Eurostat) || 13.212.000 || 11.430.000 || 12.920.000 || 13.364.800 || 12.480.700 
 % of imports/EU production || 0.0001 || 0.0004 || 0.00002 || 0.0003 || 0.000008 
-
EU live caprine imports (source TRACES)
 Origin/Year Nbr. Anim. || 2006 || 2007 || 2008 || 2009 || 2010 || 2011 
 New Zealand || 0 || 0 || 0 || 0 || 0 || 6 
 Croatia || 0 || 0 || 0 || 4 || 0 || 5 
 Chile || 0 || 0 || 0 || 3 || 0 || 0 
 Canada || 23 || 16 || 0 || 1 || 0 || 0 
 TOTAL || 23 || 16 || 0 || 8 || 0 || 11 
 EU live caprine (source Eurostat) || N/A || 13.212.000 || 11.430.000 || 12.920.000 || 13.364.800 || 12.480.700 
 % of imports/EU production || -- || 0.0001 || 0 || 0.00006 || 0 || 0.00008 
- EU live swine imports (Source Comext)
 Origin/Year Nbr. Anim. || 2007 || 2008 || 2009 || 2010 || 2011 
 Russian Federation || 135 || 792 || 1.639 || 1.382 || 170 
 Canada || 623 || 517 || 449 || 346 || 88 
 United States || 87 || 126 || 106 || 88 || 7 
 Albania || 42 || 0 || 0 || 0 || 0 
 Belarus || 20 || 0 || 0 || 0 || 0 
 TOTAL || 907 || 1.435 || 2.194 || 1.816 || 265 
 EU live porcine (source Eurostat) || 159.965.000 || 152.988.000 || 151.911.000 || 151.130.100 || 148.556.500 
 % of imports/EU production || 0.0005 || 0.0009 || 0.001 || 0.001 || 0.0002 
- EU live porcine imports (Source TRACES)
 Origin/Year Nbr. Anim. || 2006 || 2007 || 2008 || 2009 || 2010 || 2011 
 Canada || 254 || 324 || 611 || 727 || 551 || 845 
 TOTAL || 254 || 324 || 611 || 727 || 551 || 845 
 EU live porcine (source Eurostat) || N/A || 159.965.000 || 152.988.000 || 151.911.000 || 151.130.100 || 148.556.500 
 % of imports/EU production || -- || 0.0002 || 0.0003 || 0.0004 || 0.0003 || 0.0005 
-
EU live equine imports (source Comext)
 Origin/Year Nbr. Anim. || 2007 || 2008 || 2009 || 2010 || 2011 
 United States || 3.679 || 3.551 || 3.090 || 2.359 || 2.256 
 Argentina || 3.036 || 2.561 || 1.589 || 1.308 || 789 
 Belarus || 2.637 || 1.910 || 1.154 || 518 || 16 
 Iceland || 1.135 || 1.399 || 1.445 || 961 || 915 
 Croatia || 627 || 397 || 275 || 656 || 898 
 Uruguay || 790 || 449 || 421 || 248 || 26 
 United Arab Emirates || 363 || 249 || 230 || 290 || 184 
 Canada || 311 || 279 || 169 || 122 || 116 
 Ukraine || 546 || 24 || 27 || 19 || 11 
 Morocco || 322 || 46 || 36 || 59 || 92 
 Russian Federation || 105 || 139 || 86 || 126 || 83 
 Montenegro || 0 || 0 || 0 || 0 || 500 
 Australia || 130 || 104 || 92 || 71 || 65 
 Brazil || 112 || 139 || 38 || 62 || 27 
 New Zealand || 127 || 81 || 34 || 42 || 58 
 TOTAL || 26.327 || 10.606 || 7.403 || 6.081 || 9.287 
 EU live equine (DG Sanco website) || 6.000.000 || 6.000.000 || 6.000.000 || 6.000.000 || 6.000.000 
 % of imports/EU production || 0.4 || 0.1 || 0.1 || 0.1 || 0.1 
- EU live equine imports (source
TRACES)
 Origin/Year Nbr. Anim. || 2006 || 2007 || 2008 || 2009 || 2010 || 2011 
 United States || 2407 || 3094 || 2896 || 2364 || 1986 || 6530 
 Argentina || 2472 || 2615 || 2594 || 1604 || 1409 || 904 
 Iceland || 1163 || 1237 || 1452 || 1230 || 970 || 561 
 United Arab Emirates || 533 || 375 || 385 || 380 || 407 || 473 
 Qatar || 31 || 84 || 95 || 70 || 127 || 156 
 Russian Federation || 122 || 156 || 192 || 112 || 229 || 141 
 Belarus || 4255 || 2493 || 1913 || 1193 || 475 || 31 
 New Zealand || 142 || 154 || 110 || 41 || 66 || 95 
 Australia || 187 || 168 || 198 || 165 || 106 || 47 
 Uruguay || 320 || 425 || 482 || 421 || 301 || 69 
 Brazil || 125 || 85 || 188 || 59 || 139 || 74 
 Morocco || 313 || 344 || 76 || 97 || 90 || 110 
 TOTAL || 12070 || 11230 || 10581 || 7736 || 6305 || 9191 
 EU live equine (DG Sanco website) || 6.000.000 || 6.000.000 || 6.000.000 || 6.000.000 || 6.000.000 || 6.000.000 
 % of imports/EU production || 0.2 || 0.18 || 0.17 || 0.1 || 0.1 || 0.15 
II. Semen and embryo
The EU imports significant amounts of
bovine semen doses mainly from USA, Canada and to a lesser extent from New
Zealand, Australia, Switzerland and Norway. Imports from these countries are
well established for many years and are growing regularly (with high growth
trend for imports from New Zealand and Norway).
Imports of bovine semen do represent on
average 2.5 % of the total amount of semen doses used in the EU. However, this
low percentage does not reflect their importance in EU breeding schemes as
imported semen is of high genetic value for the dairy production.
Imports of porcine semen are more limited
than for bovine: the use of frozen porcine semen is very limited as the number
of piglets obtained with frozen semen is far lower than with fresh semen.
However some trade of frozen porcine semen of high genetic value takes place and
originates mostly from Canada and USA.
Imports of ovine and caprine semen are very
limited and originate mostly form USA, Canada, Australia and New Zealand.
Though import figures are low, they may be significant both in terms of
percentage and genetic value as the use of artificial insemination for ovine
and caprine in the EU is very limited compared to its use for bovine specie.
- EU bovine semen imports in doses (Source Comext)
 Origin country /  Year / Dosis || 2007 || 2008 || 2009 || 2010 || 2011 
 United States || 3.418.197 || 3.553.153 || 3.678.915 || 4.283.701 || 4.241.689 
 Canada || 2.453.611 || 2.670.217 || 2.613.608 || 3.380.888 || 3.610.052 
 New Zealand || 39.840 || 1.800 || 66.294 || 413.371 || 574.755 
 Australia || 41.933 || 78.283 || 39.142 || 44.446 || 28.778 
 Croatia || 0 || 0 || 5.010 || 21.000 || 103.011 
 China || 0 || 0 || 60.000 || 7.701 || 0 
 Serbia || 0 || 9.000 || 0 || 0 || 0 
 Philippines || 4.829 || 0 || 0 || 0 || 0 
 Costa Rica || 0 || 0 || 3.000 || 0 || 0 
 Venezuela || 0 || 1.800 || 0 || 0 || 0 
 Malaysia || 500 || 0 || 0 || 0 || 0 
 Argentina || 0 || 0 || 0 || 0 || 36 
 TOTAL || 5.958.910 || 6.314.253 || 6.465.969 || 8.151.107 || 8.558.321 
- EU bovine semen imports in doses (Source Traces)
 Origin country /  Year / Dosis || 2006 || 2007 || 2008 || 2009 || 2010 || 2011 
 United States || 115537 || 171256 || 724156 || 716299 || 817718 || 977402 
 Canada || 81963 || 172686 || 478279 || 557304 || 661156 || 898107 
 Australia || 7384 || 5832 || 11897 || 7395 || 11311 || 2225 
 New Zealand || 18549 || 297 || 14 || 1418 || 664 || 803 
 Croatia || 0 || 0 || 0 || 13 || 1000 || 84 
 Chile || 20692 || 0 || 0 || 2 || 0 || 0 
 Argentina || 4896 || 0 || 780 || 0 || 0 || 0 
 China || 0 || 0 || 14036 || 0 || 0 || 0 
 India || 0 || 36410 || 46669 || 0 || 0 || 0 
 TOTAL || 248.967 || 386.505 || 1.275.083 || 1.281.962 || 1.492.000 || 1.878.600 
-
EU porcine semen imports in doses (Source Traces)
 Origin country /  Year / Dosis || 2006 || 2007 || 2008 || 2009 || 2010 || 2011 
 Canada || 9 || 210 || 373 || 200 || 782 || 176 
 United States || 280 || 517 || 5 || 75 || 173 || 59 
 Australia || 127 || 126 || 0 || 16 || 0 || 0 
 New Zealand || 10414 || 0 || 0 || 0 || 0 || 0 
 South Africa || 0 || 0 || 73 || 0 || 0 || 0 
 TOTAL || 10830 || 853 || 451 || 291 || 955 || 235 
-
EU equine semen imports in doses (Source Traces)
 Origin country /  Year / Dosis || 2006 || 2007 || 2008 || 2009 || 2010 || 2011 
 United States || 725 || 174479 || 5898 || 3119 || 7427 || 260772 
 Canada || 523 || 1442 || 2895 || 99 || 42 || 286 
 Brazil || 0 || 0 || 0 || 0 || 0 || 80 
 Australia || 0 || 27 || 0 || 67 || 11 || 3 
 New Zealand || 0 || 0 || 0 || 0 || 2 || 2 
 Morocco || 0 || 0 || 0 || 30 || 0 || 1 
 United Arab Emirates || 0 || 0 || 0 || 19 || 1 || 0 
 Mexico || 15 || 0 || 0 || 13 || 0 || 0 
 Argentina || 0 || 30 || 18 || 0 || 0 || 0 
 Tanzania || 0 || 0 || 1 || 0 || 0 || 0 
 TOTAL || 1263 || 175978 || 8812 || 3347 || 7483 || 261144 
- EU semen imports (ovine and caprine) in doses
(Source Traces)
 Origin country /  Year / Dosis || 2006 || 2007 || 2008 || 2009 || 2010 || 2011 
 United States || 469 || 1685 || 535 || 385 || 572 || 912 
 Canada || 79 || 7 || 82 || 128 || 317 || 267 
 Australia || 312 || 586 || 265 || 63 || 177 || 242 
 New Zealand || 83 || 18 || 23 || 1763 || 14 || 14 
 Japan || 1 || 0 || 2 || 22 || 210 || 0 
 South Africa || 0 || 0 || 29 || 51 || 28 || 0 
 Brazil || 0 || 1 || 0 || 0 || 0 || 0 
 TOTAL || 944 || 2297 || 936 || 2412 || 1318 || 1435 
Imports of bovine
embryo take place on a regular basis and are reducing since 2009. They
originate mostly from Canada and USA. No figures are available for other
species.
- EU bovine embryo imports (Source TRACES)
 Origin country /  Year / Quantity (number of embryos) || 2006 || 2007 || 2008 || 2009 || 2010 || 2011 
 Argentina || 0 || 0 || 0 || 2 || 0 || 1 
 Australia || 81 || 6 || 106 || 37 || 104 || 64 
 Canada || 2008 || 3008 || 2165 || 3934 || 3762 || 2955 
 New Zealand || 0 || 16 || 0 || 0 || 0 || 1 
 Philippines || 0 || 0 || 1 || 0 || 0 || 0 
 Turkey || 0 || 0 || 0 || 0 || 1 || 0 
 United States || 2670 || 2924 || 3402 || 2959 || 2613 || 2494 
 TOTAL || 4759 || 5954 || 5674 || 6932 || 6480 || 5515 
III. Meat, meat products, milk and milk
products
1 Meat and meat products
Imports of bovine meat originate from a
wide range of countries. More than 95 % of these imports come from 9 countries
(Brazil, Argentina, Uruguay, Botswana, New Zealand, Namibia, United States,
Australia, Paraguay) and imports from Brazil, Argentina, and Uruguay
represented around 80 % of the total trade volume in 2010. These imports are on
a slow growing trend, except for USA where there are in major increase since
2010.
Imports of swine meat originate mainly from
Chile, United States, Brazil, Australia and Canada. There is no general trend
as they have increased from Brazil, Australia and decreased from Chile, USA,
Argentina, New Zealand.
Imports of ovine and caprine originate
mostly from New Zealand (around 80 %), Australia (around 10 %) and Chile,
Argentina, Uruguay and Macedonia (around 10 %). Figures are common for ovine
and caprine imports but caprine imports are very limited. There is no
significant trend as the EU is importing the vast majority of its ovine
consumption since the last decade.
- EU
bovine meat imports in tons (source Comext)
 Origin country /  Year / Quantity || 2007 || 2008 || 2009 || 2010 || 2011 
 Brazil || 181.594 || 41.951 || 40.449 || 43.578 || 45.390 
 Argentina || 57.595 || 56.168 || 73.578 || 50.168 || 44.780 
 Uruguay || 25.252 || 46.441 || 58.289 || 47.537 || 39.001 
 Australia || 6.310 || 8.952 || 10.770 || 9.556 || 12.480 
 Namibia || 8.051 || 7.960 || 9.674 || 10.440 || 6.904 
 United States || 2.061 || 4.943 || 7.394 || 11.753 || 16.171 
 New Zealand || 2.592 || 7.870 || 10.465 || 9.607 || 11.169 
 Botswana || 10.452 || 7.855 || 8.669 || 12.090 || 736 
 Chile || 2.099 || 1.832 || 2.343 || 1.861 || 1.663 
 Paraguay || 0 || 168 || 1.823 || 3.671 || 3.184 
 Serbia || 2.322 || 1.777 || 984 || 1.122 || 784 
 Croatia || 1.067 || 1.287 || 1.185 || 1.152 || 1.505 
 Canada || 883 || 679 || 572 || 551 || 707 
 TOTAL Beef Total bovine meat ||   297.582 N/A ||   188.569 391.800 ||   226.504 425.600 ||   203.429 369.900 ||   184.694 N/A 
 EU production   Beef Total bovine meat (source Eurostat) ||   6.113.00 8.204.000 ||   6.050.000 8.072.000 ||   5.612.000 7.717.000 ||   5.716.000 7.918.000 ||   N/A 7.844.000 
 % imports/EU production   Beef Total bovine meat ||   4,86 % -- ||   3,11 4,85 ||   4,03 5,51 ||   3,56 4,67 ||   -- -- 
-
EU bovine meat imports in tons (sources TRACES)
 Origin country /  Year / Quantity || 2006 || 2007 || 2008 || 2009 || 2010 || 2011 
 Brazil || 173974 || 200977 || 61276 || 40560 || 56668 || 88765 
 Argentina || 7995 || 24159 || 34354 || 39357 || 49180 || 48007 
 Uruguay || 11644 || 16361 || 46823 || 41357 || 39119 || 43046 
 New Zealand || 2315 || 4592 || 9971 || 10770 || 10457 || 28857 
 Australia || 9109 || 7331 || 9700 || 8189 || 7826 || 27114 
 United States || 242 || 1639 || 4555 || 3109 || 9292 || 15694 
 Namibia || 4030 || 5409 || 7728 || 9295 || 9044 || 10344 
 Paraguay || 0 || 0 || 144 || 1069 || 5324 || 3173 
 Canada || 526 || 759 || 673 || 555 || 528 || 2452 
 Chile || 1062560 || 1187896 || 671837 || 1206082 || 1597986 || 1763572 
 Croatia || 644854 || 1065554 || 1303234 || 1232284 || 1179209 || 1555919 
 Serbia || 0 || 1991161 || 1778254 || 978283 || 1126053 || 796406 
 Botswana || 4253350 || 7212455 || 6517167 || 10529026 || 11037246 || 689238 
 Swaziland || 0 || 74982 || 268720 || 190695 || 328487 || 38869 
 Serbia and Montenegro || 1893666 || 349895 || 0 || 0 || 0 || 0 
 South Africa || 1962395 || 1000 || 3034 || 0 || 0 || 0 
 Syrian Arab Republic || 0 || 21951 || 0 || 0 || 0 || 0 
 Thailand || 0 || 12518 || 25641 || 0 || 0 || 0 
 Uganda || 0 || 11041 || 50459 || 0 || 0 || 0 
 Viet Nam || 23130 || 12013 || 35343 || 0 || 0 || 0 
 TOTAL || 10049790 || 12201693 || 10828913 || 14290631 || 15456419 || 5111456 
- EU porcine
meat imports in tons (source Comext)
 Origin country /  Year / Quantity || 2007 || 2008 || 2009 || 2010 || 2011 
 Chile || 12.323 || 17.142 || 16.554 || 8.875 || 7.105 
 United States || 9.979 || 22.951 || 7.147 || 6.222 || 2.598 
 Australia || 1.923 || 1.557 || 879 || 1.234 || 1.736 
 Japan || 110 || 94 || 1.693 || 48 || 53 
 Russian Federation || 98 || 141 || 946 || 58 || 109 
 South Korea || 160 || 3 || 158 || 66 || 327 
 Canada || 0 || 0 || 295 || 350 || 5 
 Belarus || 148 || 0 || 60 || 190 || 97 
 Croatia || 22 || 50 || 70 || 22 || 61 
 China || 0 || 17 || 146 || 0 || 24 
 Hong Kong || 0 || 0 || 158 || 28 || 0 
 Brazil || 130 || 23 || 0 || 0 || 0 
 Ukraine || 0 || 0 || 39 || 47 || 20 
 TOTAL || 24.893 || 41.978 || 28.145 || 15.140 || 12.135 
 EU porcine meat production (source Eurostat) || N/A || 22.574.000 || 21.279.000 || 22.011.000 || 22.388.000 
 % imports / EU porcine meat production || -- || 0.19% || 0.13% || 0.07% || 0.06% 
- EU swine meat imports
(source TRACES)
 Origin country /  Year / Quantity (kg) || 2006 || 2007 || 2008 || 2009 || 2010 || 2011 
 Brazil || 28757737 || 27461301 || 19959328 || 22456542 || 40669925 || 34722611 
 Chile || 1808137 || 9181850 || 10335403 || 10454470 || 12321828 || 6589425 
 Australia || 299575 || 737652 || 649168 || 326483 || 1306825 || 3371357 
 United States || 6709709 || 27363029 || 21490418 || 6710900 || 4416382 || 2486045 
 Argentina || 5655380 || 4626748 || 1220232 || 2991189 || 2033793 || 1624437 
 Croatia (Local Name: Hrvatska) || 691875 || 794008 || 1030038 || 645050 || 1212180 || 1278558 
 New Zealand || 45602 || 187024 || 615579 || 245574 || 159525 || 109116 
 Uruguay || 42779 || 94266 || 222218 || 631154 || 2073887 || 106583 
 Canada || 50955 || 37067 || 41310 || 142883 || 315379 || 61318 
 Thailand || 156804 || 84934 || 23301 || 67186 || 149424 || 39748 
 Serbia || 0 || 0 || 0 || 13152 || 23337 || 20000 
 Botswana || 0 || 0 || 0 || 0 || 18701 || 18268 
 South Africa || 0 || 43191 || 109168 || 4155 || 567 || 0 
 TOTAL || 44218553 || 70611070 || 55696163 || 44688739 || 64701753 || 50427466 
- EU ovine
and caprine meat imports in tons (source Comext)
 Origin country /  Year / Quantity || 2007 || 2008 || 2009 || 2010 || 2011 
 New Zealand || 191.693 217.921 || 189.432 432.800 || 185.174 229.746 || 164.348 197.043 || 149.224 
 Australia || 16.920 || 18.057 || 17.645 || 14.585 || 16.639 
 Argentina || 4.646 || 4.548 || 5.912 || 4.796 || 3.605 
 Chile || 4.072 || 3.376 || 5.104 || 5.278 || 4.749 
 Uruguay || 3.627 || 3.557 || 3.426 || 2.709 || 2.994 
 FYROM || 2.605 || 2.346 || 2.598 || 2.173 || 2.574 
 Iceland || 517 || 829 || 1.404 || 1.872 || 1.210 
 Falkland Islands || 321 || 298 || 322 || 327 || 396 
 TOTAL || 442322 || 655243 || 451331 || 393131 || 181391 
 EU ovine / caprine meat production || N/A || 1.022.000 (945+77) || 808.000 (748+60) || 786.000 (725+61) || 791.000 (732+59) 
 % imports / EU ovine and caprine production || -- || 64.1% || 55.8% || 50% || 22.9% 
-  EU ovine and caprine meat imports (source TRACES)
 Origin country / Year / Quantity (kg) || 2006 || 2007 || 2008 || 2009 || 2010 || 2011 
 New Zealand || 169241349 || 207819306 || 421658085 || 218614718 || 186705599 || 237765575 
 Australia || 15753193 || 15940698 || 38283820 || 19722278 || 15058534 || 19939478 
 Chile || 1016565 || 1456320 || 1979460 || 2300314 || 3500822 || 4863268 
 Argentina || 2025915 || 2204192 || 2798619 || 3913173 || 3784742 || 3373474 
 Uruguay || 2215407 || 2328314 || 3629467 || 2788308 || 2545345 || 2803375 
 FYROM || 2299000 || 2164609 || 2274887 || 2630773 || 2365727 || 2529928 
 Iceland || 475934 || 400907 || 905287 || 941638 || 1519615 || 1199528 
 Falkland Islands (Malvinas) || 235899 || 249602 || 300086 || 293021 || 284397 || 411320 
 Greenland || 591 || 793 || 10302 || 867 || 770 || 1343 
 United States || 33476 || 64362 || 28903 || 22376 || 0 || 807 
 Brazil || 56447 || 187702 || 0 || 11829 || 127113 || 0 
 TOTAL || 193353776 || 232816805 || 471868916 || 251239295 || 215892664 || 272888096 
- EU horse meat imports in
tons (source Comext)
 Origin country / Year / Quantity (Tons) || 2007 || 2008 || 2009 || 2010 || 2011 
 Argentina || 16.414 || 13.277 || 11.921 || 8.767 || 7.300 
 Canada || 7.442 || 13.727 || 10.114 || 9.126 || 8.874 
 Brazil || 11.636 || 8.449 || 8.464 || 2.774 || 1.602 
 Mexico || 4.327 || 6.758 || 7.037 || 7.404 || 5.430 
 Uruguay || 2.785 || 2.957 || 3.034 || 2.422 || 2.884 
 United States || 3.983 || 1 || 0 || 211 || 2.038 
 Australia || 542 || 407 || 1.305 || 324 || 120 
 New Zealand || 142 || 135 || 116 || 150 || 64 
 Iceland || 13 || 36 || 46 || 26 || 0 
 TOTAL || 47.284 || 46.000 || 42050 || 31204 || 28312 
 EU horse meat production (Source Eurostat) || 56.000 || 53.000 || N/A || N/A || N/A 
 % imports / EU horse meat || 84.4% || 87 % || -- || -- || -- 
IV. Milk and milk products
The EU does import very limited quantities
of fresh milk (for dairy plants at EU borders). Therefore data on imports can
be assumed as referring to milk products (including milk powder for further
processing).
Milk products imports originate mostly from
Switzerland, New Zealand, USA and Australia.
- EU milk
imports in tons (source Comext)
 Origin country / Year / Quantity (Tons) || 2007 || 2008 || 2009 || 2010 || 2011 
 Croatia || 8.623 || 4.613 || 13.430 || 2.697 || 2.944 
 FYROM || 1.302 || 659 || 384 || 0 || 1 
 Lebanon || 0 || 0 || 0 || 0 || 773 
 Australia || 546 || 48 || 50 || 55 || 1 
 Japan || 0 || 0 || 191 || 2 || 0 
 United States || 3 || 86 || 6 || 0 || 0 
 Russian Federation || 0 || 2 || 8 || 20 || 20 
 United Arab Emirates || 0 || 0 || 0 || 0 || 43 
 TOTAL || 10474 || 5408 || 14069 || 2774 || 3782 
 EU milk production* (source Eurostat) || N/A N/A || 46.351.000 47.994.000 || 46.056.000 47.749.000 || 46.592.000 48.253.000 || 46.918.000 48.657.000 
 % imports / EU milk production || -- || 0.011% || 0.03% || 0,005 % || 0.008% 
* liquid milk and
cream
- EU milk
products* imports in tons (source Comext)
 Origin country / Year / Quantity (Tons) || 2007 || 2008 || 2009 || 2010 || 2011 
 New Zealand || 111.406 || 73.860 || 84.799 || 63.723 || 50.479 
 United States || 16.832 || 18.972 || 1.491 || 7.570 || 10.693 
 Australia || 14.008 || 9.817 || 6.828 || 4.210 || 2.773 
 Canada || 6.609 || 6.832 || 3.487 || 2.082 || 40 
 Croatia || 4.562 || 3.248 || 2.405 || 2.621 || 2.764 
 Israel || 918 || 818 || 3.254 || 948 || 1.003 
 Belarus || 2.233 || 229 || 1.140 || 79 || 0 
 Iceland || 288 || 782 || 477 || 545 || 740 
 Algeria || 221 || 236 || 32 || 164 || 276 
 China || 41 || 247 || 152 || 80 || 172 
 Malaysia || 26 || 645 || 1 || 0 || 1 
 Russian Federation || 29 || 85 || 60 || 330 || 51 
 Morocco || 41 || 21 || 246 || 200 || 0 
 TOTAL || 157.214 || 115.792 || 104.372 || 82552 || 68.992 
 EU milk products* production (source Eurostat) || N/A || 12.775.000 || 12.766.000 || 12.686.000 || 12.878.000 
 % imports / EU milk products production || -- || 1.96% || 1.84% || 0,97 % || 1.5% 
* milk powder,
butter and cheese
- EU milk and
milk products imports (source TRACES)
 Origin country / Year / Quantity (kg) || 2006 || 2007 || 2008 || 2009 || 2010 || 2011 
 New Zealand || 95108490 || 80129396 || 75292875 || 61587614 || 50565513 || 50893373 
 United States || 3434991 || 33926500 || 19124228 || 3047930 || 9002031 || 45916436 
 Croatia || 6863128 || 30169565 || 12702743 || 19507523 || 7146446 || 9488242 
 Australia || 6875292 || 11623617 || 8885125 || 3742873 || 5616374 || 5304817 
 Israel || 620006 || 1068296 || 1328196 || 2112820 || 717722 || 1077929 
 Iceland || 20057 || 302149 || 869784 || 425009 || 192319 || 712893 
 Canada || 4652339 || 5784890 || 6751666 || 3183618 || 1044195 || 72218 
 Argentina || 31745 || 15588 || 15657 || 46744 || 21202 || 40138 
 FYROM || 1129424 || 748770 || 2679875 || 365504 || 3234 || 8104 
 TOTAL || 118735472 || 163768771 || 127650149 || 94019635 || 74309036 || 113514150 

ANNEX IX: Impact in the EU and Third Countries of the EU
Measures on Animal Cloning for Food Production – Effects on Sector
Competitiveness

I. Introduction
1 Context 
In the context of the identification of
economic impacts of this initiative[144], particular attention has been
paid to factors determining productivity and subsequently to the
competitiveness of EU economic sectors involved. In this respect,
competitiveness is defined as a measure of an economy’s ability to provide its
population with high and rising standards of living and high rates of
employment on a sustainable basis. To deliver on these objectives, competition
in a supportive business environment is a key to promote growth and
competitiveness of sectors.
The EU sectors which would be
potentially affected by measures on cloning are the animal farming sector (meat
and milk production), the animal breeding sector (production of high genetic
value reproductive material) and the food and retail industry (meat and milk
production, processed foods, food imports, distribution and retail).
This analysis of impacts on
competitiveness ('competitiveness proofing')[145] is performed through an
assessment of the impacts on (i) costs and prices, (ii) innovation implications
and (iii) the international competitiveness of the sectors involved. It is mainly qualitative, working with assumptions and draws mainly on studies prepared by an external consultant (GHK IFC
2012)[146] and the Commission's own Joint Research Centre (JRC Seville 2013).[147] However, the JRC study assumes that a "mandatory traceability
and labelling system for food coming from offspring of cloned animals can be
established in third countries" and that "the existing traceability
system in third countries can be applied for the cloning technique without extra
costs[148]".  It will centre on the two main regulatory approaches (a)
the suspension approach and (b) the traceability and labelling approach.
Taking into account that productivity increases resulting from use
of cloning technique are marginal, it is assumed that cloning technique and
cloned animals will not be used in the EU for food production up to 2020. Until
then exposure of affected sectors in the EU is likely to be indirect, i.e. via
the imports of reproductive material from clones, of live offspring and the
food derived.
2
Background
The animal breeding sector aims at
improving of genetic characteristics to increase production (e.g. of meat or
milk). Breeding may indirectly affect production costs, notably feeding costs. Improvements
resulting in better feed conversion rates (unit of feed/ unit of weight gained)
are thus considered a major breeding progress as they have direct effect on the
economic performance of the livestock farming sector.
The price of
breeding stock (i.e. animals used for the purpose of planned breeding) or for
animals used for production has a rather low impact on total production costs.
For instance, considering the costs of pig meat production in EU countries in 2007[149], it emerges that breeding, veterinary medicine and energy costs are
only about 6% of the total production costs. Production costs are mainly due to
feed costs (about 50%). The situation is similar in the EU27 beef sector where
breeding costs are about 6% of the total cost of beef production. On the demand
side, farmers' share of the end consumer meat price is about 25%[150]. 
Evidence indicates[151] that productivity increases resulting from use of cloning technique
as currently performed are marginal. There is thus little economic incentive to
use it. As a result it is presumed that the technique would not be used for
food production in the EU up to 2020. 
II. Competitiveness analysis
1. Cost competitiveness
Production costs are only one of the many
factors determining the competitive strength of a sector. They are influenced
by the price, quality and dependability of purchased inputs and determined by
the costs of land, labour, capital, machinery and stock as well as fertiliser,
seed and fodder prices in e.g. animal production chains. Also in international
trade transportation and import levies may also be significant. These
additional costs counterweigh the usually higher in production costs between EU
MS and between EU MS and third counties.
a) Suspension of cloning technique in the EU, imports of live
clones, their reproductive material and their food (suspension approach).
As explained above it is presumed that the technique would not be used
for food production in the EU up to 2020. As a result the suspension of cloning
technique in the EU is not expected to have direct effects on costs for farmers
and breeders in the EU. 
There is a
contingent risk of cost created by the loss of access to imports of live
animals, reproductive materials and food derived could increase input costs for
EU food business operators. This risk would, however, only materialise if third
country trading partners would not segregate clones and their products from
other animals. In return EU farmers (especially in the meat/dairy bovine and
ovine sectors) could benefit from loss of competition from imports if exports
from third countries to the EU are disrupted or lost.
EU breeders
currently import significant amounts of reproductive material from third
counties (US and Canada) which is worth 50 millions €. Thus suspension import
of reproductive material from clones may have a significant impact on both the
EU breeding and farming sectors if third countries are unwilling or unable to
identify reproductive material from clones. In consequence imports of
reproductive material would become difficult. This could affect EU farmers if
they would lose access to imported high performance genetic resources on
certain farmer largely depend (e.g. dairy farmer using the Holstein breed).
b) Traceability and labelling of food from clones, offspring and descendants
(traceability and labelling approach) 
The cost of
labelling can be split into the cost for underlying traceability and the cost
of marking the food for retail. 
The compliance cost
of marking is negligible. Cost for adaptation or
redesign of product labels are modest: the average cost at company level for a
small label change has been estimated at €2,000-4,000. A full label redesign
has been estimated at €7,000-9,000 (or €9,000-13,000 in total). Most companies
(~80 per cent) redesign their label every three years as a normal part of their
business operation (EC 2008). 
The compliance costs
for the underlying traceability, i.e. identification of animals, of
reproductive material and of derived food becomes more costly with every
generation between the clone and the animal, reproductive material or food traded
and the degree of integration of supply chains. Increase in cost depend also on
the degree that animals are already individually identified. Bovine and equine animals
are already individually identified. For caprine and ovine species this is,
with some exceptions, the case. Porcine animals are raised and moved in
distinct groups. Thus traceability
requirements related only to animal cloning in the EU are expected to have in
principle minimal direct effects on companies’ cost competitiveness for bovine
animals if number of concerned animals[152] remains
small and no direct effects for the other species in food production in the
business (as usual baseline to 2020).
Impacts on cost
competitiveness may arise through trade losses where third countries cannot or
will not meet import traceability requirements for food. This could raise input
costs in the EU market. If all live animals or batches of live animals require
identification as a clone, offspring or descendant, the effects on cost
competitiveness could be more significant, particularly for operators working
with animal species for which profit margins are particularly low (e.g. ovine
and caprine animals).
Some of the
negative impacts may be offset if imports are restricted from third countries
due to lack of compliance with traceability requirements and thus, EU producers
would benefit from the subsequent loss of competition.
2. Capacity to innovate
The options
assessed have the potential to change genetic diversity in the EU through
changing the EU breeding sector’s access to genetics from elsewhere in the
world. If, in extremis, trade in reproductive materials ceased then EU breeders
in the dairy sector and elsewhere would need to develop alternative strategies
for the same breeds or turn to other breeds. The EU would, in functional terms,
be cut off from access to the global ‘pool’ of genetic resources.
a) Suspension approach 
As explained above it is presumed that the technique would not be used
for food production in the EU up to 2020. Elsewhere the use of the technique is
restricted to a very small number of animals and is concentrated in a single
species (bovine animals). 
The EU’s
‘exposure to the impacts of cloning over that period are likely to be indirect,
mediated though use by operators in the EU of genetic materials brought in from
North America. The net innovation impacts of the approach on cloning research
and innovation are expected to be small in the short term. Stakeholder input suggests
that EU industry would not invest in cloning for food production if
unrestricted.
Suspension could have longer and indirect effects on the allocation
of innovation investments in industry and upstream research funding by
signalling explicitly that market prospects for the technology are not positive
in the EU. Organisations looking to invest in the development of such
technologies may be more inclined to place their investments elsewhere.
This may give rise to a competitive disadvantage for EU breeding
companies on the long term. However, alternative approaches to cloning, in
particular genomic selection[153] have been developed in the EU and their potential appears higher
than that of cloning for livestock genetic improvement.
b) Traceability and labelling approach
Commercial
cloning is unlikely to occur in the EU to 2020, the introduction of
traceability requirements for reproductive material from clones is not expected
to alter this. 
There is no direct link between this approach and the capacity to
innovate in the breeding sector but an indirect link as the additional costs
for ensuring traceability and labelling of concerned animals and the lack of
market in the EU for their food could decrease the interest for the technique.
3. International competitiveness
a) Suspension approach 
The potential impacts of the suspension
approach on international competitiveness are mixed and complex. The EU is not
only the biggest importer but also a major exporter of reproductive material
(semen, embryos). European breeding organisations are competitive on the global
market for high value genetics that depends on continuous exchanges. Measures
that hamper import or export of genetic material would weaken the position of
the EU breeding sector in this global business.
Table 1 summarizes
the impacts of suspension approach on both import and export sides.
 Suspension approach: effects on the import side || Suspension approach: effects on the export side 
 ·         An interruption of imports would reduce the exposure of domestic producers to competition in the EU market and would be expected to increase their relative competitiveness / market share. This could result in EU market share in third countries declining as a larger part of domestic output is absorbed by domestic demand. For example, bovine semen that the EU currently exports might be used for domestic production and North America would be likely to replace the EU in its current markets (typically South America) ·         A loss of access to high quality genetic materials could have long term impacts on output and on productivity, both of which could negatively impact on competitiveness in price-sensitive export markets || ·         Possible positive impacts on demand for EU products in third countries if the ‘clone free’ status was perceived as a premium attribute by consumers.  ·         The acceptability of meat from clones, clone offspring and clone descendants for different religious faiths could also be relevant to the market prospects for EU products in such circumstances   
There is thus
some uncertainty about the scale and direction of the net effect on the EU’s
international competitiveness. However, it must be noted that the potential
reduction of international competitiveness through loss of market access due to
retaliatory trade measures introduced by third countries is out of the scope of
this analysis.
A quantification of the likely effects of the suspension approach on
international trade and EU domestic production has been attempted in a recent
study by Commission Joint Research Center (JRC).[154] Among the
various scenarios which have been used as a model for analysis by JRC, a
scenario[155]
considers that the cloning technique is suspended in the EU but remains
available in third country main trading partners[156] which
signed the joint statement on animal cloning for livestock production
(Argentina, Brazil, New Zealand and the USA).
Under these assumptions no trade restrictions exist and the only
difference between EU and Third countries lies in the productivity increase
associated with cloning. The results show that imports would increase slightly
in the case of a suspension of cloning in the EU but at the same time allowing
the imports of food stemming from cloning. The EU would import marginally more
cattle, beef and dairy, but the effects on prices and domestic production are
negligible as imports represent only a small part of domestic use. This
indicates that the productivity increase from cloning is not significant enough
to change trade patterns.
Trade-mediated
effects resulting from third country unwillingness or inability to comply with
the requirements may negatively impact innovation, particularly for the bovine
breeding industry which relies on imported reproductive material to improve the
quality of the breeding stock.
b)
Traceability and labelling approach 
The potential
impacts of the traceability and labelling approach on international
competitiveness have been assessed in the 2013 JRC study mentioned above. Some
of the relevant impacts are reported in Table 2 below. 
Table 2: Traceability approach - impacts on international
competitiveness
 negative impacts || positive impacts 
 Negative impacts in the case of fully comprehensive traceability for porcine, ovine, caprine and equine animal industries, due to significantly higher costs to operators (particularly breeders/farmers) in industries that already have low profit margins. This is particularly likely for pork products (batch traceability), for which the EU is a net exporter. No third country has such traceability requirements in place resulting in an advantage over EU operators in trade with other third countries. For domestic consumption, if the requirement is put in place for all third countries as well, then the overall competitiveness effect will be determined by the ease with which EU operators can comply with the requirements versus their competitors in third countries. || Traceability could have positive impacts on demand for EU products where it allowed operators to identify their products as ‘clone free’ and where this is perceived as a premium attribute by consumers. The extent to which this characteristic may be desired by consumers in third country markets is unknown.   
The traceability and labelling approach poses
the risk of triggering significant impacts on importers of food products and on
the EU food supply chain due to changes in trade patterns.  When food business
operators from third countries cannot identify food products as derived from
the offspring or descendants of clones and cannot satisfy the EU’s import
conditions for traceability, a compulsory product labelling scheme might drive
EU buyers to seek alternative supplies. This would result in changes in the
distribution of demand across the supply chain with EU buyers sourcing rather
from EU producers/farmers.
The significance of major impacts for the three
affected sectors in the context of the scenario 'suspension of imports of
clones and meat from clones' and the scenario 'traceability and labelling of
meat from clones and offspring' is summarised in table 3 below:
Table 3: Significance of the impacts of the two
scenarios on the four main actors in the food chain
 Actors   || Suspension of imports of clones and meat from clones || Traceability and Labeling of meat from clones and offspring 
 Farmers || No impact on direct cost competitiveness; in the long term, there might be a potential contingent risk of loss of access to imports of live animals and especially reproductive material. Due to the fact that it is not conceivable how large the share of cloned animal will be, and which species will be covered, this risk to innovation and competiveness is hard to estimate but likely to remain limited. Benefits (limited) due to import substitution (price increases for producers)   || Only minimal direct cost impacts for bovines; EU domestic farmers/producers will increase their market shares on the EU Single market due to slightly increased production which substitutes for decreased imports (notably from US beef and New Zealand sheep meat)   
 Traders   || No imports of all meat types from clones, which are expected to be very limited in the first place   Similarly, decreasing exports as meat demand on EU domestic market increase || For live animal imports, no significant additional costs (except USA*) due to requirements for individual animal identification For meat importers, significant additional traceability/labeling costs due to segregation of supply chains For EU exporters, potential comparative advantage on specific export markets of 'clone free' meat 
 FBO || No impact on direct cost competitiveness but in the long term potentially increased cost for private compliance mechanisms to ensure clone-free status Higher meat prices due to lack of imports and only partly substitution by domestic production (depending on species) notably for the meat processing industry || Significance of the impact on costs depending on (1) existing traceability system according to species; (2) establishment of segregated supply chains  and (3) details of labeling rules including the FBOs possibility for integration into Business-as-usual costs   
* Individual animal identification system
exists in most of the major exporting countries with the exception of the USA.
In the absence of data on the shares that Member States have on EU
imports, the significance of impacts by Member State, in order to determine
which would be most affected, cannot be made. However, in order to provide best
possible estimates, four factors can be considered:
1)
The importance of animal production: For example, 60% of EU total production of
dairy and beef originate from four countries (France, German, Italy and UK)
while in sheep and goats, biggest producers in numbers are Greece, Bulgaria,
Spain and Cyprus, with UK and Ireland also significant producers. It can be
assumed, that the potential impacts of lack of access to genetic resources from
third countries is more significant in these Member States.
2)
The importance of the use of reproductive materials potentially from clones:
This remains highly hypothetical for the time being. It is obvious that global
breeding efforts will require continuous exchange of high-quality reproductive
materials, especially for high-output species. At the same time, as the example
of the World Holstein-Friesian Association (see annex XIII) demonstrates, these
sectors are already putting appropriate traceability systems in place on a
voluntary basis.
3)
On-going cloning activities in the EU: Of the 35 companies undertaking cloning
activity worldwide, only four are active in the EU, and their commercial
activities in Europe may not include the cloning technique.[157] Only
France reported currently on-going cloning activities, but limited to sport
horses. In Germany, in the past, clones were kept in semen centres but only for
exports to third countries, not for distribution or use in the EU. Therefore,
this factor currently has no impact on Member States at all. 
4)
Imports of meat and dairy into the EU: For the main imports (beef meat from
South America, sheep meat from Australia and New-Zealand), specific impacts on
Member States- are difficult to assess once products have been introduced into
the internal market. For detailed trade numbers see annex VIII. However, imports decrease should be limited to a few products and remain
rather insignificant as it would be at least partly substituted.   
A summary of
the impacts on competitiveness of the suspension approach and the traceability
and labelling approach on the various affected EU sectors in presented in
tables 4 and 5 below.
Table 4 Suspension approach (cloning
technique, live clones, reproductive material from clones, food from clones)
Assumptions:  1) Suspension approach would reduce or cut access to
genetic resources from third countries 
2)
Cloning technique would remain considered an efficient technique for improving
livestock production.
 Competitiveness / Sectors   || Breeders / importers of RM || Farmers || Food industry and distribution/retail 
 cost and price competitiveness   || No impact Cloning technique unlikely to be used in the EU for food production up to 2020. || Negative impact   Short term: insignificant as technique is not widely spread yet and imports represent only a small part of domestic use long term: significant if performance cannot be increased though other techniques   || short term: No impact as technique is not used in EU and not widely spread in third countries long term: increased costs through non availability of imports of cheaper  conventional global market in food of animal origin yet effects on prices are negligible as imports represent only a 
 capacity to innovate   || Negative impact Direct: EU breeders cut off global gene pool Indirect: allocation investments in breeding industry  and upstream research => investments elsewhere || Negative impact If access to high performance reproductive material is disrupted or stoppedd || No impact Not the way food industry innovates   
 international competitiveness   || Negative impact   Loss of market share in the global market in reproductive material   || - No access to high quality reproductive materials => long term impacts on output/productivity - May be outbalanced by gain in special/niche market || short term: No impact long term: increased costs through non availability of imports of cheaper  conventional food of animal origin from global market. 
Table 5 Labelling and traceability
approach (traceability of live clones, reproductive material from clones, live
offspring; food from clones and offspring).
Assumptions:
 1) Labelling of food from clones and offspring can be put in place
on the EU based on existing identification and traceability systems for live
animals and reproductive material and possible adaption of food industry for
traceability and labelling of fresh meat / food from offspring.
2) Most third countries would be unable or unwilling to put in place
similar identification and traceability systems.
 Competitiveness / Sectors   || Breeders / importers of RM || Farmers || Food industry and distribution/retail 
 cost competitiveness   || No impact || increase in compliance costs due to more detailed identification of animals increase depends on degree of identification already established for species) number of generations to be identified || increase in compliance costs 1.    marking of food: negligible if incorporated into ‘label lifecycle’ 2.    traceability (identification of food through the food chain): potentially significant and increasing with: length of food chain complexity of food chain number of generations of animals to be identified raise input costs as of cheaper  conventional global market in food of animal origin not available 
 capacity to innovate   || No impact   || May trigger development of new more efficient ways to identify animals || May trigger development of new more efficient ways to ensure traceability 
 Competitiveness / Sectors   || Breeders / importers of RM || Farmers || Food industry and distribution/retail 
 international competitiveness   || Loss of share of global market in reproductive material + An interruption of imports would reduce the exposure of domestic producers to competition in the EU market and would be expected to increase their relative competitiveness / market share. This could result in EU market share in third countries declining as a larger part of domestic output is absorbed by domestic demand. For example, bovine semen that the EU currently exports might be used for domestic production and North America would be likely to replace the EU in its current markets (typically South America)   || Loss of share of conventional global market in food of animal origin May be outbalance by gain in special market and loss of competition in Internal Market   || short term: no impact long term: - increased cost through non availability of imports of cheaper  conventional global market in food of animal origin - positive impact  if EU clone free’ products are premium attribute in TCs   
III Combined scenario from JRC study.
Another scenario[158] analysed by
JRC study is to combine the suspension approach and the traceability and
labelling approach (suspension of cloning technique in the EU + mandatory
traceability and labelling of food from clones and offspring). In particular,
this scenario implies that the cloning technique is forbidden in the EU and
remains available and used in third countries which signed the joint statement
on animal cloning for livestock production (Argentina, Brazil, New Zealand and
the USA). In addition, a mandatory traceability and labelling system for food
coming from clones and offspring is established.
The following matrix (Table 6) aims
to present the results of the qualitative screening for the JRC combined
scenario.
 Competitive losses || Affected sectors || Sizing of impacts (significance) || Duration of impact || Risks and uncertainty 
 Directly || Indirectly ||   ||   ||   
 Cost and price competitiveness || Domestic EU market: Live animal importers, Importers of RM, Breeders, Food importers, processors, manufacturers, retailers   || EU exporters, consumer price increase || Indirect effects may be greater than the direct effects, particularly where trade losses occur due to third countries not being able or willing to meet traceability requirements || Short/long term || Risk of loss of access to imports of live animals and RM Potential trade losses where third countries do not meet traceability requirements to allow importers to meet requirements of suspension or traceability approach in the EU Risk of widely distributed negative impacts due to loss of imports 
 Capacity to innovate || Breeding industry, particularly bovines || EU exporters, research linked to reproduction and cell biology || Insignificant and small short term impact. Significant impact in the long horizon || Long term || Risk of inhibition of  the EU’s capacity to innovate in cloning 
 International competitiveness || Domestic EU market: Live animal importers, Importers of RM, Breeders, Food importers, processors,  manufacturers, retailers . In particular some benefits for  EU domestic producers ||  Employment impacts for FBO, consumer price increase || Negative impact on competitiveness in price-sensitive export markets especially over the longer term || Short/long term || The additional administrative burden imposed on the food chain would be expected to reduce the competitiveness of the affected sectors 
Note: RM stands for reproductive materials,
FBO stands for Food Business Operators
Under this scenario, imports increase
slightly when the EU decides not to use cloning but to allow the imports
stemming from cloning. At the same time, the additional costs of setting up traceability
systems in third countries would reduce the imports compared to the baseline
for imports of primary products. 
Concerning changes in the EU’s domestic
production, no significant differences to the baseline scenario are observed.
This is expected as the changes in imports were marginal under this scenario
and the competitive position of different sectors in the EU remains stable as
the cloning technique cannot be used by EU farmers. Similarly, changes in
import flows from main trading partners remain insignificant.
References  
De Roest, K. Jongeneel, J. Dillen, K. Winsten, J.
(2008): "Cross compliance and competitiveness of the European Beef and Pig
Sector". Research Center on Animal Production (CRPA).
Defra 2010: "Developing a Framework for Assessing
the Costs of Labelling Changes in the UK", UK 2010
DBV 2012: "Situationsbericht Landwirtschaft
2012", 
European Commission 2012: " Comparisons of
production cost structure for animal products: EU and non-EU countries",
DG SANCO 03/2010.
European Commission 2012: 'A "Competitiveness
Proofing" Toolkit for use in Impact Assessments', Commission Staff Working
document SEC(2012) 91 final 
Hoste R. (2009): "Environment and welfare melt
Dutch cost advantage", Pig Progress Volume 25 nr 3".
IFC GHK 2012: "Impact in the EU and third
countries of EU measures on animal cloning for food production", 2012. 
JRC Sevilla 2013: "Contribution to the economic
impact assessment of policy options to regulate animal cloning for food
production with an economic simulation model". 2013
Suk et al. 2007: "Dolly for dinner? Assessing
commercial and regulatory trends in cloned livestock", Nature
Biotechnology, 25(1):47-53.

ANNEX X: SME Test

I. SME in
the Food chain 
SMEs play a key role in the EU food sector, at every stage of the
supply chain. They represent nearly EUR 452 billion of turn-over, with EUR 93
billion of value added and employ about 2.7 million people in 271,000 enterprises
which are 99.1% of total Food & Drink companies, and 48.7% of total
turnover. [159]
The EU definition
of small and medium-sized and micro enterprises[160]:
 Enterprise Category || Headcount || Turnover                    or                     Balance sheet total 
 Medium sized || < 250 || ≤ € 50 million || ≤ € 43 million 
 Small || < 50 || ≤ € 10 million || ≤ € 10 million 
 Micro || < 10 || ≤ €   2 million || ≤ €   2 million 
With a view
to the main drivers in producing and marketing clones for food, 3 types of
actors mainly composed of SMEs can be identified:

 Breeding
     companies (private and public), including multiplier organisations (breeding
     companies and farmers);
 Farmers/producers
     for meat and dairy;
 Food
     industry (processing).

1.
Breeding sector 
The breeding
industry it is driven principally by SMEs. According to the European Forum of
Farm Animal Breeders (EFFAB)[161], the livestock genetics industry mainly consists of SME and small
units in larger organisations. The size of livestock breeding companies tends
to be medium scale, with at most 2000 employees, and annual turnovers not
exceeding €0.5 billion.[162] 
The small
number of players in the livestock breeding industry is the reflection of the
specificities of the industry whereby genetic improvements brought about by
breeding are cumulative (build on experience), permanent (no further breeding
input is required once a superior animal has been bred), and can be rapidly
disseminated to livestock farmers.[163]
Cloning and
the advancements in cloning techniques is expected to accelerate and intensify
the activities of the livestock genetics industry, especially with regards to
delivering semen of top bulls and boars. In cattle, where artificial
insemination (AI) can enable up to a million offspring, the economic prospects
are seen as particularly promising, especially in comparison to pigs, where AI
can produce around only 2000 offspring. [164]
Most multiplier organisations are SMEs cooperatively owned by
farmers, operating in their native language, organised in national umbrella
organisations. These national or local organisations of farm owners are
internationally co-ordinated by a small number of private, elite breeding
companies and cooperatives.
2. Farmers/producers
  Holdings structure 
In the EU
Member States with the largest cattle and dairy cow populations, the majority
of animals are kept on holdings with over 100 heads in size.  In contrast, in
the EU12 the majority of cattle and dairy cows are kept on small holdings of 9
animals or less.  
The
proportion of animals held on small holdings decreased while the number of
animals held on large holdings increased. This trend occurred across the EU27
but was more pronounced in the new EU12.[165]
The production tends to be
dominated by larger holdings in Northern Europe while the majority of cattle
farms in Southern and Eastern Member States are smaller holdings of less than
50 heads.
Structure of the producers across the main EU countries
The distribution of cattle
holdings follows a different pattern to the distribution of the cattle
population.  Over 50 per cent of European cattle holdings are located in
Romania and Poland and only 34 per cent are located in the EU15.  The majority
of holdings (79%) in Poland (98%) and Romania are of between 1 – 9 heads.
By comparison, a large
proportion of the holdings in Germany and France are of 50 heads or more (45
per cent and 60 per cent respectively). There are a larger number of dairy cow
holdings in the new EU12, the majority of which are small holdings. [166]
3. Food sector
The Food sector is
dominated by a large number of SMEs and micro-enterprises,
which can be as high especially in the dairy products industry where 72% of all
operators are micro-enterprises. 
For instance in Slovakia,
only 13% of relevant enterprises are micro-enterprises and potential impact
might be expected to be smaller, whereas in Sweden, the figure rises to 80% and
potential impact would be expected to be much larger3.
Micro Enterprises in meat sector
   || Processing and preserving of meat and production of meat products || Manufacture of dairy products || Total 
   || Total || Micro || Share || Total || Micro || Share || Total || Micro || Share 
 AT || 1,092 || 763 || 70% || 158 || 117 || 74% || 1,312 || 907 || 69% 
 BE || 823 || 571 || 69% || 442 || 373 || 84% || 1,470 || 1,020 || 69% 
 BG || 475 || 201 || 42% || 273 || 125 || 46% || 885 || 381 || 43% 
 CY || 71 || 46 || 65% || 147 || 127 || 86% || 256 || 201 || 79% 
 CZ || 1,467* || : || : || 146 || : || : || 1,613 || : || : 
 DK || 147 || 89 || 61% || 75 || 49 || 65% || 408 || 232 || 57% 
 EE || 53 || 20 || 38% || 31 || 11 || 35% || 156 || 63 || 40% 
 FI || 204 || 142 || 70% || 52 || 29 || 56% || 480 || 355 || 74% 
 FR || 10,410* || : || : || 1,457 || : || : || 12,363 || : || : 
 DE || 11,044 || 6,558 || 59% || 401 || 207 || 52% || 12,098 || 7,028 || 58% 
 HU || 592 || 334 || 56% || 100 || 53 || 53% || 901 || 517 || 57% 
 IE || 133 || 26 || 20% || 59 || 20 || 34% || 318 || 83 || 26% 
 IT || 3,559 || 2,495 || 70% || 3,295 || 2,469 || 75% || 7,875 || 5,606 || 71% 
 LV || 128 || 62 || 48% || 42 || 15 || 36% || 294 || 121 || 41% 
 LT || 176 || 69 || 39% || 69 || 46 || 67% || 336 || 162 || 48% 
 LU || 27 || 14 || 52% || 5 || 1 || 20% || 32 || 15 || 47% 
 NL || 491 || 325 || 66% || 258 || 206 || 80% || 1,046 || 691 || 66% 
 PL || 3,283 || 2,134 || 65% || 718 || 467 || 65% || 4,872 || 3,224 || 66% 
 PT || 633 || 382 || 60% || 439 || 345 || 79% || 1,411 || 891 || 63% 
 RO || 909 || 532 || 59% || 633 || 413 || 65% || 1,711 || 1,058 || 62% 
 SK || 72 || 17 || 24% || 38 || 3 || 8% || 178 || 23 || 13% 
 SI || 163 || 110 || 67% || 87 || 77 || 89% || 271 || 198 || 73% 
 ES || 4,153 || 2,771 || 67% || 1,462 || 1,168 || 80% || 7,141 || 4,295 || 60% 
 SE || 494 || 367 || 74% || 127 || 108 || 85% || 935 || 746 || 80% 
 UK || 1,035 || 545 || 53% || 543 || 357 || 66% || 2,347 || 1,354 || 58% 
 Total || 29,757** || 18,573 || 62% || 9,454** || 6,786 || 72% || 60,709 || 29.171 || 48% 
Source: Eurostat.  
The impact on the food
sector and notably the many SME will mainly draw from any new rules on
labelling. However, in considering the economic impacts that might occur due to
changes to labelling rules it is important to understand that even in the
absence of labelling legislation, pre-packed food (such as dairy products) would
still be labelled. Therefore, whilst changes in food labelling legislation may
mean some additional costs associated with including the information required,
companies producing pre-packed foods will always have costs of labelling that
are not due to legislative requirements.[167]
Food
retailers are composed of large companies (distribution chains) and of SMES
(butchers, independent food retailers, local markets).
Food retail
markets in the EU are increasingly concentrated with the market share of the
top 3 retailers ranging from 30% to 50% in most MS, sometimes reaching between
70-90% (Ireland, Sweden, Finland and Denmark). In addition, this market
concentration drives private label penetration, which has reached almost 35% in
Germany and almost 40% in the UK (2010).[168]
The impact of
new traceability and labelling rules for food would be very limited for these
distribution chains: they have already put in place traceability systems for
meat products for their own processing activities and would require their food
suppliers to put in place all relevant traceability and labelling measures. 
The impact
would be considerably higher for independent retailers, butchers, local markets
in terms of additional costs and administrative burden which could have
significant impact on their business operations.
II. Impacts
on SMEs 
1
Suspension approach
The suspension approach[169]
cannot provide an exclusion from the suspension requirements for SME
businesses, from the farming sector through to manufacturing and retail. The
approach therefore has the potential to impact on SME growth.
The expected impacts on
SMEs mirror the expected impacts on EU businesses as a whole, but would be
limited to impacts of live clones and their food which will be suspended.
Trade-mediated impacts therefore dominate. Expected impacts on the farming
sector (which has a high concentration of SMEs) are mixed: the number of
imported live animals as low but with the potential for higher prices as the
market seeks to compensate for the loss of high yielding animals. This in turn
might have short run impacts on breeding plans for some businesses and the
potential for longer run impacts on productivity growth for the sector as a
whole.
Expected scale, distribution and type of
impact on SMEs- suspension approach 
 Sectors where impacts will be concentrated || Principal impact expected || Significance 
   Live animal imports ||   Risk of loss of market in live animal imports (clones) ||   High for affected businesses but aggregate value of the trade is small 
 Importers of reproductive materials (RMs)   || No impact   ||   
 Breeders   || No impact   ||   
 Dairy/beef farmers   || Farmers need to find alternative RM suppliers to maintain output || High in Member States with high dependency on AI & imported RM   
 Food processing and retail || No access to food from clones || Low 
2 Traceability
and labelling approach
The traceability and
labelling approach[170] does not foresee exclusion
for SME businesses, from the farming sector through to manufacturing and retail,
and the approach therefore has the potential to impact on SME profit margins
and growth.
The impacts on SMEs will
vary depending on the chosen path. If all operators are subject to the
traceability requirements such that they must identify the clone status of all
animals, reproductive materials and food products then SMEs will be affected
similarly to all other EU operators. 
The requirements are more
likely to affect the profits of small producers because they do not benefit
from efficient production systems and/or economies of scale enjoyed by larger
firms. 
There is also likely to be
variance in these impacts among Member States. Some MS have a large number of
small producers. For example, in Poland (one of the EU countries with the
largest pig populations) more than 60 per cent of the pigs are kept on farms
with fewer than 50 animals. In Germany, higher production costs are already
expected to cause the exclusion from the market of a large proportion of farms
with fewer than 200 sows in 2013.[171]
Additional costs for traceability could aggravate this impact.
Expected scale, distribution and type of
impact on SMEs – traceability approach for clones, food derived from clones and
reproductive materials
 Sectors where impacts will be concentrated || Principal impact expected || Significance 
   Live animal importers || Aggregate value of the trade is small Few businesses likely to rely on trade in live animals to the EU Animals are high-value and therefore likely to be traceable with modest effort || Low  High in Member States with high dependency on AI & imported RM 
   Importers of reproductive materials (RMs)   ||   Materials are already traceable and identifiable in the major exporting countries as derived from a clone Risk of loss of access to imported reproductive materials leads to loss of business for importers where exporters cannot or will not identify reproductive materials from offspring of clones   ||   Low High   
   Breeders ||   Loss of access to high quality Holstein/other genetics would negatively affects breeding programmes if RM importers halted ||   High in Member States with high dependency on AI & imported RM   
   Dairy/beef farmers ||   Farmers need to find alternative RM suppliers to maintain output ||   High in Member States with high dependency on AI & imported RM 
   Food importers, processors, food manufacturers, retailers  and food service companies ||   Risk that import trades would be affected because exporters are unwilling or unable to meet the requirements on food products, but a supply chain solution to exclude clones from food suppliers seems more likely than a solution for clone offspring and descendants, which are more numerous and not traced ||   Low 
Labelling mainly affects the food business operators (EU food industry, food
importers, food distributors and retailers) which will have to comply with new
labelling requirements.
The first impact of
labelling results primarily from the setting up of new traceability systems or
the upgrading of existing ones in order to ensure that labelling requirements
are properly implemented. This has been assessed in the previous chapter.
The second impact of new
labelling requirements result from the adaptation of the labels and labelling
equipment and the need to replace the existing stocks of labels by new ones
(see scheme below)[172]. 
Labelling
process:
The evidence suggests that a move towards a mandatory labelling
approach could present particular challenges for micro and small enterprises.
This is because larger firms enjoy economies of scale, which lowers the cost
per-unit of complying with regulations.
The changes in food labelling legislation may mean some
additional costs associated with including the information required, companies
producing pre-packed foods will always have costs of labelling that are not due
to legislative requirements (for example printing and packaging costs).
A label change can be
triggered by various reasons; the most common ones are: changes in regulations,
marketing reasons and the producers usually change them at regular intervals.
This label's life
cycles may range from a few months for highly marketed, or it might take a few
years for niche products. Before designing/redesigning a label the company
needs to be familiar with the legislation to identify the legal requirements
for the new label.
For instance, in the
light of an administrative burden exercise UK estimated the costs attributed to
familiarisation and understanding the General Food Labelling regulations as 13%
of all administrative costs across all the food regulations. 
An administrative
measurement exercise conducted in Denmark estimates the costs associated with
familiarisation with food labelling legislation to account for 5% of the total
administrative burden associated with the food regulations.[173]
However, the recent
public consultation-based Communication on the ten most burdensome regulations
for SME revealed that only 23 organisations mentioned the Food Information for Consumers (Regulation (EC) No 1169/2011). 
In this context, it is relevant
to point to the on-going exercise on a possible country of origin labelling (COOL)
for meat and meat products as well as the revision of the Hygiene package, both
of which are taking SME impacts specifically into account.[174]
III. Conclusions
A high level of protection
of human life and health, as well as consumer protection, is the overarching objective
of all DG SANCO policies and legislation (Art 169 TFEU). 
The cross-cutting
principles of promoting health, safety and the interests of European consumers
are directly embedded in the Treaty. Therefore, as a matter of principle, all
EU legislation regarding food safety and public health should apply to all
business operators as their impact on the health and safety of citizens is highly
significant. 
The Commission is
therefore cautious when considering any exemptions or lighter regimes for SMEs
and micro-enterprises for these policy areas, since such exemptions should not
undermine the high level of protection which has already been achieved.  
Furthermore, the food
safety requirements often bring positive, direct benefits to businesses - for
example, a safe supply of raw materials for production, clear guidance to staff
handling the production process, a high degree of consumer confidence and of
our global partners and export markets.
In
conclusion, it can be stated that the difference between SME and other FBO is
not significant with reference to the factors subject to the preferred option.
This means, that although impacts can be identified,
their impact is similar on all FBO regardless of size or turnover, while the
overarching objective of the preferred option as outlined in the specific
objectives of the IA can only be achieved if no exception is granted to SME. 
References
Merks, J. (2006) The
European Perspective for Livestock Cloning, Institute for Pig Genetics,
presented at BIO2006, Chicago, 11 April 2006
Simm, G. (1998) Genetic
Improvement of Cattle and Sheep.
Gura (2007) Livestock
genetics companies: Concentration and proprietary strategies of an emerging
power in the global food economy, League for Pastoral Peoples and Endogenous
Livestock Development
IFC GHK 2012: Impact in
the EU and third countries of EU measures on animal cloning for food production,
2012
JRC 2010: Evaluation of
the livestock sector's contribution to the EU greenhouse gas emissions (GGELS),
Final report 2010
JRC 2013: Contribution to
the economic impact assessment of policy options to regulate animal cloning for
food production with an economic simulation model. JRC Scientific and Policy
Report, EUR XXXXX (forthcoming)
Food and Drink Europe Data
Trends 2012
FSA 2006: “Food Standards
Agency: Administrative Burdens Measurement Exercise: Final Report”, June 2006

ANNEX XI: Analysis of Impact on Trade in case of Suspension of
Cloning Technique

-  imports of (i) reproductive materials
of clones, of (ii) life offspring & (iii) descendants would continue to
take place without restriction (eg subject to the relevant animal health and
zoo-technical legislation applicable to all food and animals – see Summary of
legislation on animal health and import certificates.
- imports of food from these animals
(offspring and descendants of clones) would not be recognised as such and
continue to be subject to all the relevant food legislation without any change
; 
The suspension of cloning in the EU
together with the suspension of imports of clones and the food from clones has
very limited impact on trade but the clones need to identified as such
in those third countries where cloning takes place and their food from clones
not be put on the food export market. 
In addition the possible number of imported
of live clones - although there are no official figures - should be
extremely low if non-existent: imports of live animals overall is extremely
low; and the purpose of using clones is to trade their reproductive material
(which is not affected by this option) and not to trade the clones themselves;
imported live animals require documentation of the pedigree information of the
animal, to confirm it is a clone or not. This information should be relatively
easy to confirm given the small number of operators producing clones in third
countries and EU operators' awareness of the status of the imported animal[175].
Based on the information received from breeding association they would be
imported as pure bred or breeding animals for which the parentage is obligatory[176]. 

- imports of food from clones produced
in third countries   The cost to exclude food from clones from EU imports
should be minimal and be put against the very small number of clones, compared
to the livestock in third countries, and the fact that clones are not produced
for food production. The voluntary system in the USA for example enables the
food producer to decide whether or not to put it in the food chain. 

ANNEX XII: Comparison of options on impacts and of options
according to Objectives
1: Comparison of options on impacts
 
 OPTIONS || Economic || Social || Consumers 
 EU || Third country || EU Employment ||  Protection || Food prices 
 Option 1 (No Policy Change): Pre-market approval + labelling of food from clones on case by case + Directive 98/58/EC on animal welfare. || 0 || 0 || 0 || + || 0 
 Option 2 (Pre-market approval): food from offspring and descendants || - - - || - - - || - - || 0 || - - 
 Option 3 (Labelling of food) || Sub-option 1: Food from clones || Mandatory || Segregated || All food || Clones || 0 || 0/- || 0 || + + || 0 
 Sub-option 2 and 3: Food from offspring and descendants || Sub-option 4: Mandatory || Segregated || Meat || Offspring ||  - - || - - - || 0 || + + + || 0/- 
 Descendants || - - - || - - - || 0 || + + + || - 
 Other food || Offspring || - - || - - || - - || + + + || - - 
 Descendants || - - || - - || - - || + + + || - - 
 Non Segregated || Meat || Offspring || - - - || - - - || 0/- || + + + || - 
 Descendants || - - - || - - - || 0/- || + + + || - 
 Other food || Offspring || - - - || - - - || - - || + + + || - 
 Descendants || - - - || - - - || - - || + +  + || - 
 Sub-option 5: Voluntary || Segregated or non segregated** || All food || All || 0/+ || 0 || + || + || - 
 Option 4 (Suspension in EU) || Cloning technique || 0 || 0 || 0 || ++ || 0 
 Clones || 0 || 0 || 0 || ++ || 0 
 Reproductive materials of clones || - - || - || 0 || 0 || 0 
 Food from clones || 0 || 0/- || 0 || ++ || 0 
++ strongly positive; + positive; -
negative; - - strongly negative; 0 no impact.
* meat process product; milk and  milk processed products, meat
ingredients; milk ingredients. 
** Not to be set
up by regulatory measure but by the FBOs depending on their activity, facilities and traceability equipment.
                                                                                                                                                                                                                                                   

2: Comparison of options
according to objectives
 
 OPTIONS   || Specific Objectives 
 Animal welfare || Consumer Protection || Competitiveness farmers / breeders / FBO 
 Option 1 (No Policy Change): PMA + labelling of food from clones on case by case + Directive 98/58/EC on animal welfare. ||            + || + || 0 
 Option 2 (Pre-market approval):  Food from offspring and descendants || 0 || 0/+ || 0 
 Option 3 (Labelling of food) || Sub-option 1: Food from clones || Mandatory || Segregated || All food || Clones || 0 || ++ || 0 
 Sub-option 2 and 3: Food from offspring and descendants || Sub-option 4: Mandatory || Segregated** || Meat || Offspring || 0 || +++ || - 
 Descendants || 0 || +++ || - - 
 Other food** || Offspring || 0 || +++ || - - - 
 Descendants || 0 || +++ || - - - 
 Non Segregated** || Meat || Offspring || 0 || +++ || - - - 
 Descendants || 0 || +++ || - - - 
 Other food** || Offspring || 0 || +++ || - - - 
 Descendants || 0 || +++ || - - - 
 Sub-option 5 Voluntary || Segregated** or non segregated || All food || All food || 0 || + || 0 
 Option 4 (Suspension in EU) || Cloning technique || +++ || ++ || 0 
 Clones || +++ || ++ || 0 
 Reproductive materials of clones || 0 || 0 || - - 
 Food from clones || 0 || ++ || 0 
Magnitude of impact of the option to attain
the objective: ++ strongly positive; + positive; - negative; - - strongly
negative; 0 no impact.
* Milk, meat and milk processed products, meat
and milk ingredients. 
** Not to be set up by regulatory measure
but by the FBOs depending on
their activity, facilities and traceability equipment.

ANNEX XIII: Baseline Scenario (Background Information)
1. Technical Description of the Cloning Process

The animal cloning
means an asexual reproduction technique of animals that involves the genetic
material of one animal only (either a male or a female). This animal is called
the donor and the technique aims at producing an almost exact genetic copy of
the donor by using a surrogate mother. The technique does not involve any
genetic modification. 
More specifically,
the technique consists (Figure 1) in taking the nucleus (which contains the
genetic material DNA) of a cell of the donor and transferring this nucleus into
an oocyte of a female. The original nucleus of the oocyte has been excluded.
This implies that the genetic material of the oocyte has disappeared. The
oocyte containing the transferred nucleus therefore bears only the genetic
material of the donor. This new cell if successful develops into an embryo,
which is then implanted into a surrogate mother. The surrogate mother - if the
embryo develops properly - gives birth to the clone. 
Figure 1 Process on animal cloning SNCT
technique (Somatic Nuclear Cell Transfer-EFSA 2008 Scientific opinion)

This technique is rather
complicated having for the moment a high rate of failures and it is therefore
very expensive. At this moment the main species which are cloned for food
production are bovine and pigs. 

2. Price of Cloning, Cloning Activity Projected to 2020 and
simulation of the number of offspring and descendants

a. Costs of cloned animals 
Taking into account that no cloning activity is taking
place in the EU (See 1.2.1 above) it can be estimated that the economic
viability of cloning depends mainly on the cost of a clone and the pregnancy
rate: The higher the costs, the more likely the use of cloning remains
restricted to long-use high output animals (dairy cows, race horses), the lower
the costs, the more likely the use of offspring for short term use (e.g. beef
production).
Currently, the cost to produce a clone in third
countries is thought to be €12,000-15,000
(COPA-COGECA interview). These animals can sell for more than €50,000. Breeding auctions in the EU sell
good quality heifers for between €1,500-1,800 and bulls for €8,000-12,000, placing clones well above the top end of the range.
Auctions in the United States have reported sale prices for the embryos of
cloned bovine animals at a competitive price (USD 10,000-20,000), similar to
the price of a ‘conventionally bred’ high-value line.
Due to the high cost of cloning and low success rates
from SCNT techniques, cloning is currently seen as potentially useful as
‘insurance’ whereby breeders may seek to protect themselves from the premature
injury or death of highly valuable animals by creating and storing somatic cell
lines of those animals. Clones of elite animals could thus be used as sires for
multiplication of beef cattle and dairy cattle with desirable characteristics. 
b. Projection of the use of cloning in
the EU
Suk et al 2007 estimated that the offspring of cloned
cattle would likely enter the food chain somewhere in the world before 2010.
The industry's view at that time suggested that the estimated timeline for
commercialisation of cloned animal food products was: 
■     
2005 – 2010: semen and offspring from cloned
cattle and milk, meat and derivatives from offspring of cloned cattle.
■     
2010 - 2015: cloned cattle and milk, beef and
derivatives from cloned cattle would enter the food chain.
Offspring from cloned cattle did enter the food chain in
the UK in 2010 through the slaughter of two sires for dairy cattle. No other
such activity has been reported in the EU, although the EU does not currently
regulate the import of reproductive material from clones. It is possible that
additional offspring of clones have been produced elsewhere in the EU. No
clones are known to have entered the food chain in Europe to date as no
pre-market approval requests have been submitted under the Novel Foods
Regulation. 
c. Simulation of the potential number of
offspring and descendants from a cloned bull
The exponential
increase of the number of offspring and descendants happens for semen, ova and
embryos. It is particularly important when semen is used in artificial
insemination. The number of offspring from one single bull is in order of
thousands in his entire lifetime. In the case of elite bull the number of
offspring (male and female) can be as high as 5000 to 10000. In case of elite
cows and after superovulation treatment for embryo transfer, the number of
transferable embryos can be 50 embryos in her entire lifetime. Like the
artificial insemination has done for the bull, embryo transfer can greatly
increase the number of offspring that an elite important cow can produce.
Without this embryo transfer technology a cow will produce an average of 8
calves in her entire lifetime under normal management programs (See table 1 on
the simulation of number of offspring and descendants).
 Table 1 Simulation of number of
offspring and descendants
   || Offspring first generation (usually half female and half male) || Descendants Second generation (only female offspring*** used- and males sent to slaughtering) || Descendants Third generation (only female offspring*** used- and males sent to slaughtering) 
 Elite Bull * || 5000- 10 000 || 20 000  - 40 000 || 80 000 - 160 000 
 10 elite bulls from the 2500-5000 males || 50000 -100 000 || 200 000 – 500 000 
 10 elite cows from the 2500-5000 females || 500 || 2000 
 TOTAL || 5000 – 10 000 || 70 500 -140 500 || 282 000 – 662 000 
 Elite cow** (after superovulation treatment for embryo transfer) || 50 || 200 || 800 
 5 elite cows from the 25 females || 250 || 1000 
 1 elite bull from the 25 males || 5000 – 10 000 || 20 000 – 40 000 
 TOTAL || 50 || 5450 -10 450 || 21 800 – 41 800 
Source Information provided by UNCEIA (French National Association of
livestock & Artificial Insemination Cooperatives).
*An elite bull can produce in average between 5000 and 10000 offspring
first generation (half male and half female).
**An elite cow can produce in average 50 offspring first generation
(half male and half female). 
***A cow will produce an average of 8 calves in her entire lifetime
under normal management programs

3. Background Information on Cloning-Companies, Number of Clones in
third countries and Supply Chain Management for clones in the US

a. Cloning companies
Based on the information gathered by the consultant GHK
on companies' websites few companies carry out cloning only – most of them are
also producers of other livestock reproductive material. The consultant did not
succeed in getting any information directly from the cloning companies. The GHK
study also reports that JRC study (2007)[177]
found that of the 35 companies undertaking cloning activity worldwide, nine of
these applied cloning technology to cattle.  Four of these companies are
represented in the EU, although their commercial activities in Europe are not
thought to include use of the cloning technique.
 Company Name || Head Office || # Employees || Revenue || Europe Offices || Presence in key third countries 
 AltaGenetics || Canada || Canada: 5-10 US: 50-100 || Canada: $500,000 US: $10-$25m || NL || Uruguay, Argentina, Chile, US 
 Celentis || NZ || Celentis: 50-100 AgResearch: 780 || Celentis: $10-$25m AgResearch: 157.7m ||   ||   
 Cyagara/ Goyaike* || US || 1001-5000 ||   ||   || Brazil, Argentina 
 Genus/ Bovec/ ABS || UK || 1000-5000 || 309.9m  (Euro) || IT, DE, FR, IE || US, Canada, Brazil, Argentina, Australia, Chile 
 Minitube (Intl Centre for Biotechnology) || US || 400+ || US: $10-$25m ||   || Asia, Australia, North American, South America 
 TransOva || US || 50-100 || $10-$25m ||   ||   
 Viagen || US || 50-100 || $1-$15m ||   ||   
 Yangling Keyuan cloning co. || China || 50+ || 2-3m (RMB) ||   ||   
Source: Cloning company websites
b. Number of clones in USA
Information
provided by USA cloning companies (TransOva and ViaGen) to DG SANCO on 9
December 2012 by teleconference.
 Species || Number of clones in the USA || Success rate of cloning technique || Cost of a clone 
 Bovine || 1100 (50% male and 50% female) || 10 to 20% depending of races || 18000$ 
 Pigs || 190 || >50% || 1500$ for each piglet (6 on average) 
 Horses || >100 || 15% || 165000$ 
 Sheep || 0 || -- || -- 
 Goats || At start || No information provided || No information provided 
c. Supply Chain
Management for Clones in the US
A
paper-based supply chain management programme for verification of clones was
set up in the US but has since been discontinued. It was implemented
voluntarily in the US for clones (but not their offspring or descendants) and
reached to the point of slaughter. The system was developed by the largest US
livestock cloning companies, ViaGen and Trans Ova Genetics. 
The
Supply Chain Management Program (SCMP) involved a registry system that followed
livestock clones from birth to death and carcass disposal. The key components
of the program were education, a national clone registry, affidavits, and
incentives (Figure 2). 
Figure 2 US
Livestock Cloning Supply Chain Management Program Overview 
Source:
http://www.clonesafety.com/documents/SCM_How.pdf
The Colorado based company,
AgInfoLink, managed the database of animals identified with an Animal
Identification Number. The system was designed to manage only cloned animals,
not their offspring. Consultation with the cloning industry in the US indicates
that the SCMP system was operational for five years but that it was
discontinued because there was no demand for it, neither from consumers nor
from companies. No claims for labelling of cloned pedigrees were submitted.
 The program functioned as
follows: 
■ Cloning
company contracts to produce animal following owner education. 
■ Owner
signs an affidavit committing to proper marketing or disposal of animal or milk
products. 
■ Owners
get refunded an incentive deposit they had previously paid to the cloning company
when they notify the company of animal death (verified by a veterinarian),
consumption by owner (verified by the meat locker) or sale to a
packer/processor who accepts livestock produced through cloning (verified by a
signed statement from the packer/processor). 
■ The incentive deposit was
based on a value higher than market value for a similar animal. 

4. Genetic
Diversity

Regarding genetic diversity, the suspension of
the cloning technique should have no major impact as the breeding sector has to
pay much attention to avoid consanguinity and avoid having too many animals
with the same genetics
Traditional breeding of farm animals already concentrate
on the genetic improvement of specific traits (such as milk yield or meat
production), which results in a reduction of animal species and a low range of
breeds in particular in industrialised countries[178].
 
Cloning can be used commercially to duplicate elite
breeding animals and therefore reduce the number of animals used in breeding
programmes. This could contribute to the further loss of genetic diversity
(EFSA, 2008). Breeding programmes utilising only a few bloodlines also may
increase the susceptibility of an animal population to risk factors such as
infection by disease and climate change (EFSA, 2008).
EFSA (2008) reports that, where used appropriately and
with suitable management measures, these adverse effects can be avoided. While
EFSA foresees no ‘new or additional’ environmental risks from cloning, the data
are limited (2008). This was confirmed in the updated EFSA 2012 statement
(EFSA, 2012).
In the dairy sector consanguinity could in the future
become a serious problem[179] as a high output dairy
cattle breeds like the Holstein account already for 75 per cent of the world's
milk supply (FAO 2007)[180]. This situation is not
necessarily linked to cloning but could be
exacerbated if cloning is used widely in third countries
and their reproductive material imported in the EU. 

5. World
Holstein Friesian Federation Guidelines for Registered Clones
 International Embryo Transfer Society (IETS)
     forms (or forms with similar format and information) should be completed
     and submitted to appropriate breed association prior to, or with
     application for registration of a clone. The type of cloning technology
     should be provided by the company producing clones -- cells from an adult
     animal, a foetus; or an embryo. 
 A code or suffix should be used in the name or as
     a part of the record of identification. This code or suffix should show on
     certificates of registration, pedigrees, and all other official
     Association documents. NOTE: (Holstein Canada records the code “ETA” on
     the second line, under the name of an animal, on a certificate of
     registration if cells are from an adult animal or foetus, and uses ETN if
     cells are from an embryo. Holstein USA uses the suffix “ETN” in naming all
     clones.) 
 When a cloned calf is registered, the breeder of
     the entity from which the nuclear material originates should be recorded
     as the breeder and the breeder’s prefix should be used in the name. 
 The name of each clone should be distinguished by
     an Arabic number starting with the digit 2 either preceding the suffix or
     at the end of the name. Cloned calves can be registered with the same name
     as the source animal followed by the appropriate Arabic number. The sire
     and dam of a clone should be the same as the sire and dam of the source
     animal, foetus or embryo. 
 The identification of the source animal should be
     recorded on the registering Association’s records and associated with the
     registration record for the resulting clones. This information should be
     made available, if requested.
 Each breed association should establish its own
     policy on the amount of parentage testing to be conducted, using either
     DNA genotyping or blood typing, but it is recommended that all clones be
     DNA genotyped or blood typed. The testing results must show that the
     source animal and clones have identical genotypes/blood types. 
 Each breed association should establish its own
     policy and procedure relating to the registration of progeny of a clone. 
 If cloned animals or embryos resulting from
     cloning are exported, the accompanying documents should provide all
     information required by the Association in the importing country. 

WHFF-Council
Recommendation (October 2006, Killarney, Ireland).
[1] opinion of 2008 up-dated in 2009, 2010 and 2012
[2] Regulation (EC) N° 258/97 of the European Parliament and the
Council of 27 January 1997 concerning novel foods and novel food ingredients.  
[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 for 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/get

[5] Directive 98/58/EC of 20 July 1998 concerning the protection of
animals kept for farming purposes; see in particular Article 3 and 4 and Point
20 of its Annex.
[6] For the selection
of these third countries see Annex III (Paragraph 2).
[7] Breeding companies in third countries and as, in the USA,
organisation and data base sponsored by industry of a "supply chain
management system" to track clones and exclude them from the food supply
chain the data bases in the USA and Canada contain the DNA profile of the
clones. See Annex XIII Paragraph 4).
[8] EuroCommence
considers that “should food methods from clones and offspring be authorised for
the EU market, a practical solution needs to be found to enable traceability of
these products along the whole food supply chain”.
[9] Europeans’ attitudes towards animal cloning
http://ec.europa.eu/public_opinion/flash/fl_238_en.pdf
[10]http://ec.europa.eu/governance/impact/planned_ia/docs/2013_sanco_007_use_of_cloning_technique_for_food_production_en.pdf
[11] Food safety, animal health and welfare and
environmental impact of animals derived from cloning by
SCNT and their offspring and products obtained from those
animals (opinion and statements): 
http://www.efsa.europa.eu/en/efsajournal/doc/767.pdf  ; http://www.efsa.europa.eu/en/efsajournal/doc/319r.pdf; http://www.efsa.europa.eu/en/efsajournal/doc/1784.pdf ; http://www.efsa.europa.eu/en/efsajournal/doc/2794.pdf
[12] Ethical aspects of animal cloning for food supply 16 January 2008:
http://ec.europa.eu/bepa/european-group-ethics/docs/publications/opinion23_en.pdf
[13]   Source ICF-GHK study on animal cloning December 2012. 

[14] Embryo clones
need to be distinguished for the “embryo” classified under reproductive
material. The first is a clone, the second not.
[15] EU citizen
concerns were threefold (in descending order % of replies, see page 11 of the
summary http://ec.europa.eu/food/food/resources/docs/eurobarometer_cloning_sum_en.pdf)
1. (84%): the EU do not know enough about the
long term health and safety effects of using cloned animals for food.
2. (75%): Cloning for human consumption could
not be seen just as a technical issue, since there could be ethical grounds for
rejecting such cloning.
3. (69%): using cloning for food production
purposes would be unacceptable because it would mean that animals are treated
as commodities rather than creatures with feelings.
[16] LOV nr 550 af 24/06/2005 - Lov om kloning og genmodificering af dyr
m.v https://www.retsinformation.dk/Forms/R0710.aspx?id=2116
[17] EFSA opinion of 2008 and Statement of 2012 
[18] EFSA Statement of
2012 overall conclusion p.18.
[19] i.e. the 2008 and
2010 Eurobarometer and the IPM consultation for the cloning study

[20] The
lack of consumer confidence in beef following the crisis in 2000 resulted in a
severe drop of beef consumption which was solved through a set of EU measures,
including the mandatory labelling of the national origin

[21] European Parliament Resolution of 3 September 2008 on
the cloning of animals for food supply.
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P6-TA-2008-0400&format=XML&language=EN

[22] European Parliament Resolution of 7 July 2010 on Novel Food.
http://www.europarl.europa.eu/sides/getDoc.do?type=TA&reference=P7-TA-2010-0266&format=XML&language=EN
[23] The Conciliation on this proposal failed in May 2013. http://ec.europa.eu/food/animal/identification/bovine/elec_id_bovine_en.htm
[24] OJ L 221,
8.8.1998, p. 23
[25] Communication from the Commission to the
European Parliament and the Council on the European Union Strategy for the
Protection and Welfare of Animals 2012-2015, COM(2012) 6 final/2 15.2.2012 http://ec.europa.eu/food/animal/welfare/actionplan/docs/aw_strategy_19012012_en.pdf

[26] Regulation (EC) No 258/97 of the European
Parliament and of the Council of 27 January 1997 concerning novel foods and
novel food ingredients OJ L 43, 14.2.1997, p. 1
[27] Regulation (EC)
No 1760/2000 of the European Parliament and of the Council of 17 July 2000
establishing a system for the identification and registration of bovine animals
and regarding the labelling of beef and beef products and repealing Council
Regulation (EC) No 820/97, OJ L 204, 11.8.2000, p. 1
[28] Council Directive
2008/71/EC of 15 July 2008 on the identification and registration of pigs, OJ L
213, 8.8.2008, p. 31
[29] Council
Regulation (EC) No 21/2004 of 17 December 2003 establishing a system for the
identification and registration of ovine and caprine animals and amending
Regulation (EC) No 1782/2003 and Directives 92/102/EEC and 64/432/EEC, OJ L 5,
9.1.2004, p. 8–
[30] Universal Equine
Life Number (UELN).
[31] Where derogations are applied in specific Member States for certain
or all stock of the ovine and caprine species, the animals have to be
registered by batches in the national data bases.
[32] 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
[33] http://ec.europa.eu/food/animal/zootechnics/legislation_en.htm
[34] http://www.whff.info/search/index.php.
[35] Eurostat data 2011.
[36] Eurostat Structural Business Statistics (2009).
[37] Source  Food
Drink Europe – data & trends of European Food and Drink Industry 2012. 
[38] Food Drink Europe: Data trends 2012.
[39] Food
and Agriculture organisation – livestock’s long shadow – environmental issues
and options (2006).   
[40] European
Commission 2011: 'EU Beef farms report 2010', DG AGRI 2011.
[41] Dematawewa, C.M.B., & Berger, P.J. 1998: "Break-even cost
of cloning in genetic improvement of dairy cattle". Journal of Dairy
Science 81(4): 1136-1147.
[42] European Commission 2010: "Evolution of the market situation
and the consequent conditions for smoothly phasing out the milk quota
system" 8.12.2010 COM(2010) 727 final.
[43] DG SANCO survey to Member States and third countries regarding
cloning activity, 2012.  
[44] Kanter, J. (2010) ‘Cloned Livestock Gain a Foothold in Europe’, New
York Times, July 29, 2010, available from:
http://www.nytimes.com/2010/07/30/business/global/30cloning.html?pagewanted=all.
[45] Carroll, R. (2011) ‘Argentinian polo readies itself for attack of
the clones: Player forms alliance with genetics laboratory to clone equine
champions in hope of replicating performance’, The Guardian,
http://www.guardian.co.uk/world/2011/jun/05/argentinian-polo-clones-player,
2011 
[46] There are no
statistics on EU use of reproductive material; the share of imports is therefore
based on estimates – source : Commission report of 2010  
[47] ICF GHK report 2012
[48] Figures based on 2006-2011 COMEXT
data
[49] Communication on the European Union Strategy for the Protection and
Welfare of Animals 2012-2015 COM(2012) 6 final/2. http://ec.europa.eu/food/animal/welfare/actionplan/docs/aw_strategy_19012012_en.pdf
[50] Regulation (EU) No 1169/2011 of the
European Parliament and of the Council of 25 October 2011 on the provision
of food information to consumers. 
[51] Under this
option, a streamlined and centralised approval process would be introduced
which would involve the Commission and EFSA 
[52] Streamlined procedure was already foreseen in the original
Commission proposal of 2008 (referred to in Section 1.1 above)
[53] Stakeholder consultations in meetings of Advisory Group on the Food
Chain and bilateral meetings. 
[54] Fees perceived by Member State agencies to make the scientific risk
assessment under Novel Food Regulation.
[55] Estimation done by assuming the equivalence with the costs of
filing an application under Novel food Regulation. Source: Impact assessment
on Revision of Regulation 178/2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Authority
(EFSA) and laying down procedures in matters of food safety on the
establishment of fees for EFSA.
[56] Source : EFSA impact assessment, Annexes page 56  
[57] Source ICF-GHK study on animal cloning December 2012.
46 Source
Impact Assessment Report on general food labelling issues 30/01/2008, SEC
(2008) 92
[59] EDA (European Dairy Association); Eucolait (European Association of
Dairy Trade); UECBV (European Livestock and Meat Trade Union); CLITRAVI
(liaison Centre for the Meat processing industry in the EU); Food and Drink
Europe. 
[60] According to EFSA, if the comparator for
cattle cloning is in vitro fertilisation (IVF), the background (i.e. the percentage
of live offspring per transferred embryo from IVF) is 45-60%. Compared to this
efficiency of IVF, the efficiency of cloning can be estimated at 13-25%.
[61] Which is the case at present.
[62]     Cloning for food production - BEUC comments on the European
Commission report at http://www.beuc.org/Content/Default.asp?PageID=2139
[63] In terms of (i) not presenting any novelty aspect justifying their
inclusion in a Novel Food Regulation and of (ii) not raising food safety
concerns as indicated by EFSA.
[64]     Cloning for
food production - BEUC comments on the European Commission report at http://www.beuc.org/Content/Default.asp?PageID=2139
[65] Food Drink Europe; British Agricultural Bureau, the European Forum
of Farm Animal Breeders (EFFAB); the European Dairy Association (EDA); and
European Association of Dairy Trade (Eucolait); European farmers /cooperatives
(Copa Cogeca).
[66] Source : EFSA IA annexes page 56 
[67] Sources Eurostat 2012
[68] Source ICF-GHK study on animal cloning December 2012, page 18  
[69]  European
association of farmers /cooperatives (Copa Cogeca).
[70] IFC GHK 2012
[71] IFC GHK 2012
[72] The working time necessary as a minimum to
learn the new legal requirements and define what is necessary to record the new
information has been estimated at one hour per farm. For breeding companies
this time has been estimated at 70 hours per company. The minimum time
necessary on a yearly basis to record the data and report it has been estimated
at 2 hours per operator. Source : ICF-GHK Study  
[73] As
explained in Section 5.5. there is no physical difference between food from
clones, food from their progeny and food from other animals. 
[74]Although it is unlikely that all reproductive material of a single cloned
will be used in one country.
[75] Milk from the animals is mixed in one tank at farm level and dairy
plant level ; separate systems  already exist in some Member States for the
collection of milk produced with specific requirements (related to animal feed,
animal welfare etc.) but for larger production and with added value which
compensate extra costs. 
[76] The European
Dairy Association (EDA). 
[77] However, in this case, the traceability of the milk is no longer
needed as it is destroyed and does therefore not enter the food chain. 
[78] This is confirmed by evidence from an on-going study 2013: 'Study
on the application of rules on voluntary origin labelling of foods (VCOOL)'
FCEC (forthcoming) commissioned by the Commission that shows that segregation
of supply chains can have significant impacts, depending on the sector, company
and production method. For the last factor, in the case of continuing
production process, the change to batch production in order to ensure
segregation of different supplies can imply significant investments and
adaptations of production processes. This is particularly the case for
processed products. 
[79]  European association of farmers
/cooperatives (Copa Cogeca).
[80] Food Drink
Europe. 
[81] EFSA concluded there is no safety issue
-see paragraph 2.1.
[82] In particular
European association of retailers (Eurocommerce) and European Livestock and
Meat Trade Union (UEBCV).
[83] No ICF-GHK figure on cost calculation for third country companies.
[84] Result of ICF-GHK
interview of private breeding companies. 
[85] It has to apply both in the third country which export to the EU
and also the other third countries from which either live animals or
reproductive materials are supplied.
[86] The EU requirements for individual
identification apply (as described in section 2.6.1.) only if these animals are
exported live or their reproductive material is exported to the EU. 
[87] Joint statement
on animal cloning for livestock production of 16 March 2011 by Argentina,
Brazil, New Zealand, Paraguay, United States at www.ustr.gov.
Correspondence to Commission of 26. October 2012 signed by missions or
embassies of Argentina, Brazil, New Zealand and United States in Brussels 
[88] Meat and milk from our main trading partners may be exported to
other international markets where consumption and financial resources are
significantly increasing.
[89] Sources Eurostat 2012 – see table 2 in Section 2.6.3., paragraph
c).
[90] It has to apply both in the third country which export to the EU
and also the other third countries from which either live animals or
reproductive materials are supplied.
[91] As it is a prerequisite to label food from
descendants.
[92] Meat and milk from our main trading partners may be exported to
other international markets where consumption and financial resources are
significantly increasing.
[93] Including embryos, which are part of the cloning process as defined
in Annex XIII paragraph 1,  and which if the cloning process is successful,
will become life clones.  
[94] In fact according to a relatively recent study, there should be an
increase in the milk production if cloning were more used in Europe: Butler,
L.J., McGarry Wolf, M. (2010) 'Economic Analysis of the Impact of Cloning on
improving Dairy Herd Composition', AgBioForum, 13(2): pp. 194-207.
[95] Buttler study 2010 Economic analysis of the impact on improving
dairy herd composition. AS bioforum 13(2):194-207.
[96] European association of farmers /agri cooperatives (Copa Cogeca).
[97] European Livestock and Meat Trade Union (UEBCV)
[98] Source ICF-GHK study.
[99] European farmers/agri cooperatives (Copa Cogeca); European
association of retailers (Eurocommerce);  the European Association for Animal
Production (EAAP); the International Committee for Animal recording (ICAR); the
International Embryo Transfer Society (IETS); the French institute for
agronomic research (INRA) 
[100] European farmers/agri cooperatives (Copa Cogeca)
[101] Intra-Union
trade and imports of live animals and reproductive material must be accompanied
by "health certificate" delivered by official authorities in Member
States and Third Countries as described in Annex III. 
[102] Charter of Fundamental Rights of the European Union (2000/C 364/1)
Article 38 on Consumer protection.
[103] Charter of Fundamental Rights of the European Union (2000/C 364/1):
Article 16 on freedom to conduct a business.
[104] Option 3 is
divided in five sub-options: sub-option 1 (food from clones), sub-option 2
(food from offspring), sub-option 3 (food from descendants), sub-option 4
(voluntary labelling), sub-option 5 (mandatory labelling).
 +++ strongly positive; ++average positive +limited positive, - -
-strongly negative, - - average negative; - limited negative; 0 no effect.
[105] Eurostat, TRACES
(Commission management tool for tracking the movement of animals and of
products of animal origin from both outside of the EU and within EU territory).

[106] This is done by using the naturally occurring genetic variations
that exists always between individual animals.
[107]http://ec.europa.eu/governance/impact/planned_ia/docs/2013_sanco_007_use_of_cloning_technique_for_food_production_en.pdf
[108] As defined in Commission Roadmap on measures on animal cloning for
food production in the EU
http://ec.europa.eu/governance/impact/planned_ia/docs/2013_sanco_007_use_of_cloning_technique_for_food_production_en.pdf
[109] Food products derived from clones are highly unlikely since clones
are scarce and expensive and, it is assumed, could be excluded through
pragmatic measures without putting EU trade as a whole at risk.  
[110] Council
Directive 94/28/EC laying down zootechnical and genealogic conditions
applicable to imports from third countries of semen, ova and embryo.
[111] Could be
replaced by genealogic documents issues by semen centres.
[112] OJ L 31, 1.2.2002, p. 1.
[113] Article 18 of
Regulation (EC) No 178/2002; Guidance on the implementation of Articles 11, 12,
14, 17, 18, 19 and 20 of Regulation (EC) No 178/2002 on General Food Law - Conclusions
of the Standing Committee on the Food Chain and Animal Health, January 2010, to
be found at: http://ec.europa.eu/food/food/foodlaw/guidance/docs/guidance_rev_8_en.pdf.
 
[114] OJ L 242, 20.9.2011, p. 2.
[115] However, it does
not apply to foods containing
both products of plant origin and processed products of animal origin.
[116] OJ L 139, 30.4.2004, p. 55.       
[117] Regulation (EC) No 1760/2000 of the European Parliament and of the
Council of 17 July 2000 establishing a system for the identification and
registration of bovine animals and regarding the labelling of beef and beef
products and repealing Council Regulation (EC) No 820/97 (OJ L 204, 11.8.2000,
p. 1).
[118] Commission Regulation (EC) No 1825/2000 of 25 August 2000 laying
down detailed rules for the application of Regulation (EC) No 1760/2000 of the
European Parliament and of the Council as regards the labelling of beef and
beef products (OJ L 216, 26.8.2000, p. 8).
[119] Council Regulation (EC) No 21/2004 of 17 December 2003 establishing
a system for the identification and registration of ovine and caprine animals
and amending Regulation (EC) No 1782/2003 and Directives 92/102/EEC and
64/432/EEC (OJ L 5, 9.1.2004, p. 8).
[120] Council Directive 2008/71/EC of 15 July 2008 on the
identification and registration of pigs (OJ L 213, 8.8.2008, p. 31).
[121] Eurostat data 2011
[122] Eurostat Structural Business Statistics (2009)
[123] Meat demand in
Northern America and Europe would remain globally stable by 2050 but still remain
highest in the world by 2050 at around 89 kg per inhabitant (against an
estimated 83 kg in 2010); Source : Food and Agriculture organisation –
livestock’s long shadow – environmental issues and options (2006).   
[124] European Commission 2011: EU beef farms report 2010', DG AGRI 2011
[125] DBV 2012: Situationsbericht 201/13 – Trends und Fakten zur Landwirtschaft',
2012
[126] Gura, 2007
[127] USDA, 2008
[128] No data on national imports of reproductive material from third countries
are available. 
[129] ICF GHK report
2012
[130] Figures based on
2006-2011 COMEXT data
[131] DG SANCO survey
to Member States and third countries regarding cloning activity, 2012  
[132] Kanter, 2010
[133] See 5
[134] See 13
[135] Carroll, 2011
[136] Carroll, 2011
[137] Kanter, 2010
[138]Sources "Data and Trends of the European Food and Drink
Industry 2012" of FoodDrink Europe.
[139] Value includes all fresh, frozen, chilled, prepared and preserved
bovine meat, offal and derived products including gelatine
[140] ICF GHK 2012
page 34
[141] Comext: is a statistical database on trade of
goods managed by Eurostat, the Statistical Office of the European Commission.
[142] TRACES: is a management tool for tracking the movement of animals and
products of animal origin from both outside of the European Union and within
its territory.
[143] N/A: not available
[144] This annex has
been elaborated based on available data and information (see list of
references). It reflects the policy options as identified in the IA report,
except where otherwise stated. 
[145] European Commission 2012: 'A "Competitiveness Proofing"
Toolkit for use in Impact Assessments', Commission Staff Working document SEC(2012)
91 final
[146] IFC GHK 2012:
"Impact in the EU and third countries of EU measures on animal cloning for
food production", Final report to DG SANCO, 6 December 2012.
[147] JRC 2013:
"Contribution to the economic impact assessment of policy options to
regulate animal cloning for food production with an economic simulation
model", JRC Scientific and Policy Report, EUR 25856 JRC 79995
[148] This assumption is however in contradiction with the third
countries joint statement and no data on costs for third countries are
available.
[149] DG SANCO 2009:
'Draft background paper – the EUs role in the Global Food Supply Chain', based
on Dutch Agricultural Economics Research Institute (Hoste R. (2009):
Environment and welfare melt Dutch cost advantage. Pig Progress Volume 25 nr 3)
and CRPA (De Roest, K. Jongeneel, J. Dillen, K. Winsten, J. (2008): Cross
compliance and competitiveness of the European Beef and Pig Sector. Research
Center on Animal Production (CRPA))
[150] Von
Thunen-Institut 2013.
[151] IFC GHK 2012
[152] The assumption is that only animals which are derived from cloning
(clones or offspring) and reproductive material from clones would be subject to
additional traceability requirements and that no additional traceability
requirement would apply to other animals and reproductive material.
[153]  Genomic selection is based on detection at embryo level of the
genetic potential of animals. This technology saves much time and resources compared
to classical selection based on testing of adult animal performances for meat
or milk production.
[154] JRC 2013: In the
study the choice was made to perform the analysis through the use of a
computable general equilibrium model called GLOBE. The different model
scenarios are constructed based on combinations of the identified policy
options such as suspension; traceability and labelling requirements with the
productivity increase associated with cloning.
[155] Scenario 3 of
2013 JRC study.
[156] Most of them signed the joint statement on animal cloning for livestock
production (Argentina, Brazil, New Zealand and the USA).
[157] Suk et al. (2007). Dolly for dinner? Assessing commercial and
regulatory trends in cloned livestock. Nature Biotechnology, 25(1):47-53.
[158] Scenario 4 of 2013 JRC study.
[159] Food
Drink Europe: Data trends 2012
[160] It is worth
noting that this classification does not apply to the agriculture sector
[161] http://www.effab.org/ 
[162] Gura, 2007
[163] Simm et al. 1997
[164] Merks, 2006
[165] GHK, 2012
[166] GHK, 2012
3 IA OCR, 2012
[167] IA FIC 2008
[168] Food Drink Europe 2012: Data and trends 2011
[169] No use of
cloning technique in the EU
[170] Imports of clone
from TC allowed only if full traceability is provided 
[171] http://www.thepigsite.com/reports/?category=903&id=903
[172] Defra May 2010, "Developing a Framework for Assessing the
Costs of Labelling Changes in the UK", Report
[173] FSA (2006), “Food Standards Agency: Administrative Burdens Measurement
Exercise: FinalReport”, June 2006.
[174] http://ec.europa.eu/governance/impact/planned_ia/roadmaps_2012_en.htm#SANCO

[175] GHK study table
7.2. page 52 
[176] See Annex XI. 
[177] Suk et al. (2007). Dolly for dinner? Assessing commercial and
regulatory trends in cloned livestock. Nature Biotechnology, 25(1):47-53.
[178] The impact of genetic selection for increased milk
yield on the welfare of dairy cows. PA Oltenacu and DM Broom. 
[179] The impact of genetic selection for increased milk yield on the
welfare of dairy cows. PA Oltenacu and DM Broom
[180] FAO, 2007. 'The
state of the World's Animal Genetic Resources for Food and Agriculture'