COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE 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 - 52013SC0520 - EN











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52013SC0520

COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY OF THE IMPACT ASSESSMENT /* SWD/2013/0520 final */









Table of Contents
1..... Problem
definition.. 2
2..... Analysis
of subsidiarity.. 3
3..... Objectives
of EU initiative.. 3
4..... Policy
options. 4
5..... Comparison
of options. 6
6..... Monitoring
and evaluation.. 6
Executive Summary

1.         
Problem definition 

Cloning is a
relatively new technique which allows the asexual reproduction of an individual
animal. Cloning does not involve any genetic modification and the clone is not
a GMO. In fact, the clone is a near exact genetic copy of the original animal
(the donor). Although the cloning technique itself does not improve the
animal's performance, breeders may consider cloning beneficial because it
allows increasing the quantity of reproductive material (semen, ova or
embryos) of a particularly valuable animal.
Cloning is used in research and the
production of medicinal products and medical devices. It is also a method to
increase the population of rare breeds or endangered species. 
In farming, cloning is used to multiply the
reproductive material of high performance "elite" animals[1].
Predominantly the semen of male animal clones is used for artificial
insemination, i.e. with a traditional breeding technique. 
Offspring is
the first generation where one parent is a clone, while descendants are all
further generations where none of the parents is a clone.
Clones are usually not bred and raised to produce
food (hereafter "food from clones"). While food could be obtained
from clones produced for other purposes as a side-effect, this would be economically
unattractive and thus rather unlikely.
According to the information available to the
Commission, there is currently no cloning activity in the EU for food purposes.
The European Food Safety Authority (EFSA)[2] concluded that
there is no indication of any difference for food safety for meat and milk of
clones and their progeny compared with those of conventionally bred animals.
However, cloning
of farm animals for food production is under discussion for three reasons:  
(a)   Welfare
and health of animals linked to the use of the cloning technique
EFSA 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 of the 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 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. Following this
failure, the European Parliament called upon the Commission to present a
proposal on cloning based on an impact assessment.
The following
actors could be affected by potential measures: 
-         
EU farmers which raise animals for food
production;   
-         
EU breeders which produce or import reproductive
materials (semen, embryo and ova);
-         
EU food industry (including distribution, retail
and importers) which places food on the EU market;  
-         
EU consumers as beneficiaries of availability of
food products; 
-         
Third country[3] breeding/cloning
companies and food operators who export reproductive material, live animals and
food of animal origin to the EU if cloning takes place in their country.

2.         
Analysis of subsidiarity 

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.

3.         
Objectives of EU initiative 

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.

4.         
Policy options 

In light of the
issues and objectives outlined above, 4 options were analysed:
Option 1: no policy change. 
Summary of the option 
-    Food: pre-market approval (PMA) for food from clones under
existing Novel Food Regulation - Cloning technique: Member States address
concerns by implementing Directive 98/58/EC.
This option
appears to have the lowest economic impact of all options but does only
partially address consumer concerns and animal welfare. It incurs costs for
food business operators (FBOs)[4] if they were to apply for
a marketing authorisation. No request for authorisation has ever been filed and
therefore no food from clones has been marketed so far in the EU. 
If such
authorisation would be granted mandatory labelling of food from clones and prerequisite
tracing could be required for the product authorised. However, in view of the
aforementioned EFSA opinions, it is doubtful whether an authorisation could be
refused.   Moreover, this option carries the risk that Member States address
animal welfare concerns with potentially diverging national legislation
supplementing Directive 98/58/EC. Finally, as this option covers only the
cloning technique, farmers and breeders could still import cloned animals.
Option 2: Pre-market approval (PMA) of food from clones, food from
offspring and descendants[5].
Summary of the option 
-    Food: PMA for food from clones, their offspring and descendants

-    Cloning technique: Member States address concerns by
implementing Directive 98/58/EC.
-    Traceability : systems needed for the live animals,
reproductive material and the derived food.
The costs for
FBOs to obtain PMA would be considerably higher, as more food would be covered
by this option. Moreover, FBOs would have to be able to distinguish food from clones,
offspring or descendants, by linking it to an individual animal, and to a valid
authorisation[6]. Regarding the impacts of
identification and traceability, reference is made to option 3. This would hardly
be possible for importers and their third country suppliers. Food prices are
likely to increase due to additional compliance costs. 
Option 3: labelling of food (from clones, offspring and descendants)

Summary description of the option 
- food obtained from (i) clones, or from (ii) offspring or (iii)
from descendants; 
- labelling could be (iii) voluntary or (iv) mandatory.
This option requires,
as pre-requisite, identification and traceability of cloned animals, their
reproductive material and of food obtained thereof. To ensure the labelling is
correct, it is necessary to create a documented link between a food and the animal
(animal clone, the offspring, the descendant). 
Regarding
identification of animals, Union operators are already obliged under Union
legislation[7] to identify individual animals
of most species. The costs and feasibility of traceability of animals, their
reproductive material and of the food depend largely on the scope of the
measure. 
Tracing food
from cloned animals would concern only a very low number of animals in
the EU. 
Conversely, tracing
food to offspring and descendants would affect much more food and a much higher
number of animals in the EU. Moreover, it would imply identifying and tracing
the individual animals descending from clones as well as their reproductive
material.  This is more costly with every generation between the clone, the
animal (be it offspring or descendant), the reproductive material and the food.

The
traceability requirements for food to an individual animal and for animals
across generations would have significant impacts on the EU food supply chain. Operators
would need - throughout their operations - to be able to recognise whether
every food is derived or not from progeny of clones. This would incur considerable
costs. 
Segregation of the
food chain between “clone/progeny” and “non-clone/progeny” may limit
implementation costs in terms of traceability. Yet such segregation would cause
considerable market disruption, since all food business operators would have to
obtain food from specific predetermined sources. 
Third countries
generally do not dispose of individual animal identification systems and of
national databases like the Union. In view of the costs, it is unlikely that
third country operators would establish systems for the EU market only. No third
country has expressed any readiness to put in place EU like identification and
traceability systems. This option may therefore create major trade disruptions
with the EU.
For the
aforementioned reasons, farmer and industry representatives expressed themselves
against labelling of food from offspring and descendants. They also underlined
the risk of trade disruption.  
Under this
option animal welfare problems are not directly addressed.
Option 4: Temporary suspension of the technique and of imports of
live clones, their reproductive material and their food.
Summary description of the option 
-    Food: Suspension of import of food from clones.
-    Cloning technique: Suspension of the cloning technique in the Union and of imports of live clones and of their reproductive material. 
The impact on
Union FBOs and trade is limited because trade in live clones,  if any, is very
limited and – as mentioned under Option 1- no food from clone has been marketed
in the EU up to now.  The cloning technique seems to be currently not used in
the EU for food purposes. However, traditional breeding techniques use reproductive
material from clones to produce offspring. Therefore, suspending 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.
This option has
a positive impact on animal welfare and creates a level playing field for all
farmers and breeders in the Union.

5.         
Comparison of options 

In comparing the aforementioned policy options, and considering
their impacts, it appears that option 4 (excluding the suspension of import of
reproductive material) is best suited to address the objectives set out in
section 3. It addresses better animal welfare concerns and consumer concerns than
options 1 and 2, while avoiding the economic repercussions of options 2 and 3. 

6.         
Monitoring and evaluation

The monitoring
and evaluation can be carried out through various means, namely on the basis
of: 
-           
scientific progress monitored by EFSA for option
1 and 4 (to assess whether cloning is still a breeding that causes unnecessary
pain), 
-           
the number of applications made and pre-market approvals
(option 1 and option 2) to assess which food has been authorised, 
-           
surveys at national or EU level to assess which
food is labelled (option 3) on the EU market, and possible changes in consumers'
attitude towards cloning (option 4), 
-           
statistics[8] on the number
of clones/offspring/descendants raised in the EU or imported (option 3).
-------------
[1]       Particular
in USA and Canada.
[2]       Opinion of
2008 up-dated in 2009, 2010 and 2012.
[3]       Mainly for bovine (food production)
and to a lesser extent for porcine and even less for caprine and ovine;
primarily in the US, Canada, Argentina, Brazil and Australia but possibly also
in other third countries. The number of clones is not known but should be
relatively low in view of the high costs and low success rate of the technology
(source: consultant's study and Commission questionnaire- details in Annex III).
[4]       Estimated up
to 400.000 €  and where the application is referred to EFSA for an opinion,
additional 83 000 € per application for Novel Food to be borne by the EU
budget.
[5]       This option 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. As the offspring and the following generations present exactly
the same characteristics (produced with traditional breeding techniques), it is
appropriate for sake of coherence and completeness that this option also
includes food of the following descendants of clones.
[6]       See impacts
of traceability of food from offspring and descendants in option 3 below,
paragraph b) and c).
[7]       Mainly on
animal health and zootechnics.
[8]       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).