# EUR-Lex - 52013PC0893 - EN

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# 52013PC0893

**Proposal for a COUNCIL DIRECTIVE on the placing on the market of food from animal clones /* COM/2013/0893 final - 2013/0434 (APP) */**

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EXPLANATORY MEMORANDUM

1.           CONTEXT OF THE PROPOSAL

1.1.        Background of the proposal

Cloning is a relatively new technique of
asexual reproduction of animals producing near exact genetic copies of the
animal cloned, i.e. without modification of genes.

In food production cloning is a new technique.
Hence, under the current legislative framework, food from clones falls under
the scope of the Novel Food Regulation[1]
and is thus subject to pre-market approval based on a safety risk assessment.

In 2008 the Commission presented a proposal[2] to streamline the
approval process in the Novel Food Regulation. In the legislative procedure
lawmakers aimed to amend the proposal to introduce specific rules on cloning[3]. Yet no agreement was
reached on the scope and features of these insertions so that the proposal was not
adopted by the co-legislators after the Conciliation failed in March 2011. As a
result the Commission was asked to prepare a legislative proposal on cloning in
food production based on an impact assessment outside the Novel Food Regulation[4].

The European Food Safety Authority (EFSA) concluded that there is no indication of
any difference for food safety for meat and milk of clones and their progeny
compared with those of conventionally bred animals. However
EFSA has identified animal welfare hazard related to the low efficiency of the
technique. It up-dated its opinion on cloning of animals last in 2012[5] concluding that
scientific knowledge available on cloning has increased but that nevertheless
its efficiency remains low compared to other reproduction techniques.

1.2.        Objectives of the proposal

The objective of this proposal is to address consumer perceptions on the use of food from
animal clones.

1.3.        Regulatory framework

Animal cloning is a new technique in food
production. Thus, currently, food derived from animal clones falls under the
scope of the Novel Food Regulation. Under this Regulation food produced by new
techniques can only be marketed after specific authorisation. Such pre-market
approval must be based on a favourable assessment of the risk for food safety
which is to be undertaken by EFSA. No application has ever been submitted for
an authorisation to market food produced by means of the cloning technique.

1.4.        Consistency with other
policies and objectives of the Union

This initiative responds to the above-mentioned
concerns while avoiding unnecessary burdens for farmers, breeders or food
business operators established in the Union and in third countries. The
proposal envisages a suspension on Union territory of the marketing of food
from clones.

The provisional prohibitions of the marketing
of food from clones complements the suspensions of the use of the technique for
farming purposes and the marketing of live clones proposed in a parallel measure.
The provisional prohibition of the marketing of food from clones is also kept
under review to take account of potential changes in consumer
perceptions on cloning linked
to animal welfare concerns and of international
developments.

2.           RESULTS OF CONSULTATIONS
WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENT

2.1.        Consultation process

2.1.1.     Consultation methods and
main sectors targeted

Member States, stakeholders and third countries
trade partners were consulted.

The Standing Committee for the Food Chain and
Animal Health was the main forum for discussions with Member States. In
addition all Member States completed a specific questionnaire on cloning on
their territory.

Stakeholders were consulted in the Advisory
Group of the Food Chain. Twenty-two organisations representing all sectors
concerned (farmers, breeders, food industry, retailers, consumers and animal
rights activists) participated. In addition 5 technical meetings were held with
organisations representing farmers, breeders and food industry.

A specific questionnaire was sent to the 15
major third country trade partners of which 13 replied.

The general public was consulted via the
Interactive Policy Making Initiative in March 2012. This tool reaches
approximately 6000 subscribers with 360 replied[6].

Two Eurobarometer surveys addressed cloning: a
2008 specific survey on cloning[7]
performed in 27 Member States and a 2010 survey on biotechnology[8] with specific questions
on cloning performed in 27 Member States and 5 non-Union European countries.

The specific report on cloning by the European
Group on Ethics in Science and New Technologies (EGE) of 2008[9] expressed doubts that
animal cloning for farming purposes can be justified "considering the
current level of suffering and health problems of surrogate dams and animal
clones". The EGE also concluded that it did "not see
convincing arguments to justify the production of food from clones and their
offspring".

2.1.2.     Summary of responses and
how they have been taken into account

Member States confirmed that animals are
presently not cloned for food production in the Union. The economic sectors
involved (farming, breeding, food industry) indicated that they have, at this
time, no interest to produce food from animal clones.

Argentina, Australia, Brazil, Canada, and the United States confirmed that animals are cloned on their
territory but could not indicate to what extent. In Brazil, Canada and the United States clones are registered
by private companies. In Canada the legal situation on
cloning is similar to that in the Union, i.e. food produced from animal clones
is considered novel and requires pre-market approval. Argentina, Australia, Brazil, Canada, New Zealand, Paraguay and the United States pointed out that
measures should be science-based. They moreover stressed that measures should
be no more trade-restrictive than necessary to fulfil legitimate objectives.

Union citizens, on the other hand, hold a
broadly negative perception of the use of the cloning technique for the
production of animals for farming purposes. As a result
consumers would not want to eat food derived from a clone.

This initiative takes account of the results of
the consultations. It addresses justified concerns in a proportionate manner
and considers the limits of the powers conferred to the Union by the Treaties.

2.1.3.     External expertise

In 2008 the European Food Safety Authority
(EFSA) delivered an opinion on cloning. It focused on animal clones, their
progeny and of the products obtained from those animals. This opinion was up-dated
by three statements in 2009, 2010 and 2012[10].
Based on the available data EFSA saw animal welfare problems related to the
health of surrogate mothers (carrying the clones) and the clones themselves.
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 6 % for porcine species) and
the need to implant embryo clones into several dams to obtain one clone. In
addition, clone abnormalities and unusually large offspring result in difficult
births and neonatal death. A high mortality rate is a characteristic of the
cloning technique.

On the other hand EFSA repeatedly stated that cloning
has no impact on the safety of meat and milk obtained from the clones.

2.2.        Impact
assessment[11]

Based on the experience gained in the legislative procedure which
failed in March 2011 and the positions expressed by stakeholders, four options
were assessed. Option 4 included, among others, the temporary suspension of the
placing on the market of food from clones.

As a result of the analysis of the four options, and considering
their impacts and the objectives pursued, this element of Option 4 was retained
as the basis of the present proposal. Its impact on Union food business
operators (FBOs) and trade is limited because trade, if any, is likely to be insignificant
as FBOs have no interest to market food from clones.

This option has a positive impact on citizens:
their concerns about animal welfare will be addressed as no food from clones
will be placed on the market in the Union.

3.           LEGAL ELEMENTS OF THE
PROPOSAL

3.1.        Legal basis

The Treaty does not provide, for the adoption
of this Directive, powers other than those under Article 352. This Directive
addresses animal welfare concerns of consumers related to the use of a reproduction
technique that has no impact on the safety or quality of the food produced but
implies animal suffering. Article 169 TFEU calls the Union to promote the
interest of consumers when adopting measures under Article 114 in the context
of the completion of the internal market. Under Article 13 TFUE, in formulating
and implementing the Union's internal market policy, the Union and the Member States must pay full regard to the welfare requirements of animals since animals are
sentient beings. According to an established case-law[12], the choice of Article
114 TFUE as a legal basis is justified where there are differences between
national rules which are such as to hinder the functioning of the internal
market. Recourse to that provision is also possible if the aim is to prevent
the emergence of such obstacles to trade resulting from the divergent
development of national laws. However, the emergence of such obstacles must be
likely and the measure in question must be designed to prevent them. In the
present case, no current or likely divergence between national legislations was
detected. Moreover, during the
Conciliation referred to in paragraph 1.1. above, Member States expressed their
willingness to see measures on cloning at EU level, but they did not specify
which type of national measures they would put in place in the absence of EU
initiative.

3.2.        Subsidiarity principle

Isolated Member States measures on food from clones,
if adopted, could lead to distortions of the markets concerned. Moreover, the
measure concerns import controls. It is thus necessary to ensure that the same
conditions apply and thus to address the matter at Union level.

3.3.        Proportionality
principle

Animal cloning in food production has no benefit for the consumer
and the food industry has no interest to market food from clones. At its
present state of development it also appears that its use in food production is
of limited benefit. The suspension of the marketing of food from clones
complements the suspensions of the use of the technique for farm purposes and
the marketing of live clones (animal clones) proposed in a parallel measure and
thus strikes a reasonable fair balance between animal welfare, citizens'
concerns and the interests of farmers, breeders and other stakeholders
involved.

3.4.        Choice of instruments

The proposed instrument is a Directive. Other
types of measures would not be appropriate for the following reasons:

(i)      a directive allows Member States
employ existing control tools as appropriate for the implementation of Union
rules and thus to limit the administrative burden;

(ii)     soft law instruments are considered
insufficient to prevent the use of a technique throughout the Union.

In accordance with the Joint Political
Declaration of Member States and the Commission on explanatory documents,
Member States have undertaken to accompany, only in justified cases, the
notification of their transposition measures with one or more explanatory
documents explaining the relationship between the components of a directive and
the corresponding parts of national transposition instruments. Considering the
limited legal obligations set by this Directive, explanatory documents from the
Member States in the context of transposition of this Directive are not needed.

4.           BUDGETARY IMPLICATION

This initiative has no budgetary implications
for the EU and requires no additional human resources in the Commission.

2013/0434 (APP)

Proposal for a

COUNCIL DIRECTIVE

on the placing on the market of food from
animal clones

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the
Functioning of the European Union, and in particular Article 352(1) thereof,

Having regard to the proposal from the European
Commission,

After transmission of the draft legislative
act to the national Parliaments,

After obtaining the consent of the European
Parliament,

Acting in accordance with a special
legislative procedure,

Whereas:

(1)       Food from animal clones,
as food derived from a new reproduction technique, falls within the scope of
the Regulation (EC) No 258/97 of the European Parliament and the Council[13] and is thus subject to
pre-market approval.

(2)       An
opinion of the European Food Safety Authority (EFSA) first adopted on 15 July
2008 and confirmed in 2009, 2010 and 2012[14] found no indication of any differences in food safety between food
products from healthy animal clones and their progeny compared with those from
healthy conventionally bred animals. However, EFSA also
concluded that animal welfare problems related to the health of surrogate
mothers, namely those carrying the clones, and the clones themselves exist[15]. EFSA concluded that
surrogate dams suffer in particular from placenta dysfunctions contributing to
increased levels of miscarriages. This contributes, amongst other things, to
the low efficiency of the cloning technique, which is 6% to 15 % for animals of
the bovine species and 6 % for animals of the porcine species, and the need to
implant embryo clones into several dams to obtain one clone. In addition, clone
abnormalities and unusually large offspring result in difficult births and
neonatal deaths. A high mortality rate is a characteristic of the cloning
technique.

(3)       The specific report on
cloning by the European Group on Ethics in Science and New Technologies (EGE)
of 2008[16]
expressed doubts that animal cloning for food production purposes can be
justified "considering the current level of suffering and health problems
of surrogate dams and animal clones".

(4)       The majority of Union
citizens disapprove of cloning for food production due to animal welfare and
general ethical concerns. They do not want to consume food from animal clones.

(5)       The use of cloning
technique and the placing on the market in the Union of embryo clones and
animal clones for farming purposes is provisionally prohibited by the Directive
[number] of the European Parliament and of the Council on the cloning of
animals of the bovine, porcine, ovine, caprine and equine species kept and
reproduced for farming purposes[17]. However, this prohibition does not apply
to animals kept and reproduced exclusively for other purposes.

(6)       In order to address consumer
perceptions on cloning linked to animal welfare concerns it is necessary
to ensure that food from animal clones does not enter the food chain. Less
restrictive measures, such as food labelling, would not entirely address
citizens' concerns since the marketing of food produced with a technique that
implies animal suffering would still be allowed.

(7)       Animal cloning is allowed
in certain third countries. Therefore, measures should be taken to avoid the
import into the Union of food obtained from animal clones produced in those
third countries.

(8)       It is expected that the
knowledge on the impact of cloning technique on animal welfare will increase.
The cloning technique itself may improve over time and thus become more
acceptable to consumers.

(9)       The measures laid down in
this act should be reviewed within a reasonable period of time to evaluate
whether they adequately address the objectives pursued by it taking into
account the experience gained by the Member States in the application of this
Directive, consumer
perceptions on cloning linked
to animal welfare concerns and international developments.

(10)     The Treaty does not
provide, for the adoption of this Directive, powers other than those under
Article 352. This Directive addresses animal welfare concerns of consumers
related to the use of a reproduction technique that has no impact on the safety
or quality of the food produced but implies animal suffering. Article 169 of
the Treaty calls on the Union to promote the interests of consumers when
adopting measures pursuant to Article 114 thereof in the context of the
completion of the internal market. Article 13 of the Treaty, provides that in
formulating and implementing the Union's internal market policy, the Union and
the Member States are to pay full regard to the welfare requirements of animals
since animals are sentient beings. According to the established case-law of the
Court of Justice of the European Union, the choice of Article 114 of the Treaty
as a legal basis is justified where there are differences between national
rules which are such as to hinder the functioning of the internal market.
Recourse to that provision is also possible if the aim of the act is to prevent
the emergence of such obstacles to trade resulting from the divergent
development of national laws[18].
However, the emergence of such obstacles must be likely and the measure in
question must be designed to prevent them. In the present case, no current or
likely divergence between national legislations was detected.

(11)     This Directive respects the
fundamental rights and observes the principles recognised by the Charter of
Fundamental Rights of the European Union, and notably the freedom to conduct a
business. This Directive has to be implemented in accordance with these rights
and principles.

HAS ADOPTED THIS DIRECTIVE:

Article 1
Subject matter

This Directive establishes rules for the placing on the market of
food from animal clones.

Article 2
Definitions

For the purposes of this Directive, the following definitions shall
apply:

(a)          "Cloning" means asexual
reproduction of animals with a technique whereby the nucleus of a cell of an
individual animal is transferred into an oocyte from which the nucleus has been
removed to create genetically identical individual embryos ('embryo clones'),
that can subsequently be implanted into surrogate mothers in order to produce
populations of genetically identical animals ('animal clones').

(b)          "Food" means food as
defined in Article 2 of Regulation (EC) No 178/2002[19].

Article 3
Provisional prohibitions

1.           Member States shall ensure that
food from animal clones is not placed on the market.

2.           Member States shall ensure that
food of animal origin imported from third countries where food from clones can
be legally placed on the market or exported is only placed on the market of the
Union according to any specific import conditions adopted under Articles 48 and
49 of Regulation (EC) No 882/2004 of the European Parliament and of the
Council, ensuring that no food from animal clones will be exported to the
European Union from these third countries.

Article 4
Penalties

Member States shall lay down the rules on penalties applicable to
infringements of the national provisions adopted pursuant to this Directive and
shall take all measures necessary to ensure that they are implemented. The
penalties provided for must be effective, proportionate and dissuasive. Member
States shall notify those provisions to the Commission by [date for
transposition of the Directive] at the latest and shall notify it without delay
of any subsequent amendment affecting them.

Article 5
Reporting and Review

1.           By [date = 5 years after the date
of transposition of this Directive], the Member States shall report to the
Commission on the experience gained by them on the application of this
Directive.

2.           The Commission shall present a
report to the European Parliament and the Council on the application of this
Directive taking into account:

(a)     the reports submitted by Member States
in accordance with paragraph 1;

(b)     changes in consumer perception on cloning
linked to animal welfare concerns;

(c)     international developments.

Article 6
Transposition

1.           Member States shall bring into
force the laws, regulations and administrative provisions necessary to comply
with this Directive by [date = 12 months after the date of adoption of this
Directive]. They shall forthwith communicate to the Commission the text of
those provisions.

When Member States adopt those provisions, they
shall contain a reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member States shall
determine how such reference is to be made.

2.           Member States shall communicate
to the Commission the text of the main provisions of national law which they
adopt in the field covered by this Directive.

Article 7
Entry into force

This Directive shall
enter into force on the twentieth day following that of its publication in the Official
Journal of the European Union.

It shall apply
from [date = 18 months after the date of adoption
of this Directive].

Article 8
Addressees

This
Directive is addressed to the Member States.

Done at Brussels,

For
the Council

The
President

[1]               Regulation (EC) N° 258/97 of the European Parliament
and the Council of 27 January 1997 concerning novel foods and novel food
ingredients.

[2]               Proposal for a Regulation of the European Parliament
and of the Council on novel foods COM(2007) 872 final of 14.01.2008.

[3]               Report from the Commission to the European Parliament
and the Council on animal cloning for food production COM (2010) 585 of
19.10.2010 suggested to (i) to suspend temporarily the use of the cloning
technique, clones and of food from clones 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/getDoc.do?pubRef=-//EP//TEXT+TA+P7-TA-2011-0327+0+DOC+XML+V0//EN
(Procedure 2011/2627(RSP), point 31)

[5]               EFSA Statement of 2012 overall conclusion p.18. EFSA
statements 2012 and 2010: http://www.efsa.europa.eu/en/efsajournal/pub/2794.htm
and 
http://www.efsa.europa.eu/en/efsajournal/pub/1784.htm

[6]               Of which: 34 came from professional organisations, 34
from non-governmental organisations,16 from national administrative bodies, 1
from a third country, 9 from enterprises, 26 from the academia, 10 from Member
States and 230 from individuals.

[7]               European attitudes towards animal cloning http://ec.europa.eu/food/resources/docs/eurobarometer
cloning

[8]               Special Eurobarometer, Biotechnology report, October
2010    
http://ec.europa.eu/public_opinion/archives/ebs/ebs_341_en.pdf

[9]               Ethical aspects of animal cloning for food supply 16
January 2008:      
http://ec.europa.eu/bepa/european-group-ethics/docs/publications/opinion23_en.pdf       
http://ec.europa.eu/bepa/european-group-ethics/docs/publications/opinion23_en.pdf

[10]             Food safety, animal health and welfare and
environmental impact of animals derived from cloning by SCNT and their
offspring and products obtained from those animals (opinion and statements):    
http://www.efsa.europa.eu/en/efsajournal/doc/767.pdf;           
http://www.efsa.europa.eu/en/efsajournal/doc/319r.pdf;          
http://www.efsa.europa.eu/en/efsajournal/doc/1784.pdf;         
http://www.efsa.europa.eu/en/efsajournal/doc/2794.pdf

[11]             See for further details the accompanying Impact
assessment Commission Staff working document SEC (2013) XXX.

[12]             See for example C‑58/08 Vodafone [2010] ECR p.
I-4999, paragraphs 32 and 33 and the case-law cited.

[13]             Regulation (EC) N° 258/97 of the European Parliament
and the Council of 27 January 1997 concerning novel foods and novel food
ingredients (OJ L 43, 14.2.1997, p. 1).

[14]             Scientific Opinion of the Scientific Committee Food
Safety, Animal Health and Welfare and Environmental Impact of Animals derived
from Cloning by Somatic Cell Nucleus Transfer (SCNT) and their Offspring and
Products Obtained from those Animals                
http://www.efsa.europa.eu/en/topics/topic/cloning.htm?wtrl=01

[15]             Opinion and statements on food
safety, animal health and welfare and environmental impact of animals derived
from cloning by SCNT and their offspring and products obtained from those animals:    
http://www.efsa.europa.eu/en/efsajournal/doc/767.pdf; http://www.efsa.europa.eu/en/efsajournal/doc/319r.pdf; http://www.efsa.europa.eu/en/efsajournal/doc/1784.pdf;
http://www.efsa.europa.eu/en/efsajournal/doc/2794.pdf

[16]             Ethical aspects of animal cloning for food supply 16
January 2008:      
http://ec.europa.eu/bepa/european-group-ethics/docs/publications/opinion23_en.pdf

[17]             [to be completed when text is adopted].

[18]             See for example C‑58/08 Vodafone [2010] ECR p.
I-4999, paragraphs 32 and 33 and the case-law cited.

[19]             Regulation (EC) No 178/2002 of the European Parliament
and of the Council of 28 January 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety Authority and
laying down procedures in matters of food safety, OJ L 31, 1.2.2002, p. 1.