EN Official Journal of the European Union C 311/73

Opinion of the European Economic and Social Committee on the ‘Proposal for a Directive 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’

COM(2013) 892 final — 2013/0433 (COD)

‘Proposal for a Council Directive on the placing on the market of food from animal clones’

COM(2013) 893 final — 2013/0434 (APP)

‘Proposal for a Regulation of the European Parliament and of the Council on novel foods’

COM(2013) 894 final — 2013/0435 (COD)

2014/C 311/12

Rapporteur: José María Espuny Moyano

On 16 January 2014 the European Parliament, and on 15 and 17 January 2014 the Council, decided to consult the European Economic and Social Committee, under Articles 43, 304 and 114 of the Treaty on the Functioning of the European Union (TFEU), on the

Proposal for a Directive 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

COM(2013) 892 final — 2013/0433 (COD)

Proposal for a Council Directive on the placing on the market of food from animal clones

COM(2013) 893 final — 2013/0434 (APP)

Proposal for a Regulation of the European Parliament and of the Council on novel foods

COM(2013) 894 final — 2013/0435 (COD).

The Section for Agriculture, Rural Development and the Environment, which was responsible for preparing the Committee's work on the subject, adopted its opinion on 1 April 2014.

At its 498th plenary session, held on 29 and 30 April 2014 (meeting of 30 April), the European Economic and Social Committee adopted the following opinion by 174 votes to 2 with 5 abstentions.

1. Conclusions and recommendations

1.1 Cloning

1.1.1 The EESC believes it is necessary and appropriate to regulate cloning of animals in the EU with the aim of ensuring uniform conditions of production for farmers, while protecting the health and welfare of animals and the expectations of consumers.

1.1.2 Taking into account the opposition of the public and of consumer organisations, and the insufficient technical knowledge, the EESC supports the temporary suspension of animal cloning and imports of animal clones for farming purposes in the EU.

1.1.3 The EESC points out that the suspension is not based on known health risks but on ethics and animal welfare.

1.1.4 The EESC believes that the ban should not apply to areas such as cloning for research purposes where the use of the technique is justified.

1.1.5 The EESC believes that the temporary ban could be reviewed in the future, purely taking into account the experience that Member States gain in implementing the legislation, scientific and technical progress and the development of the international environment, as well as the opinion of the public and of consumer organisations.

1.1.6 The EESC questions whether adequate techniques for distinguishing between cloned animals and animals produced using techniques currently permitted in the EU, particularly as regards imports, really exist; in this connection it demands that the full traceability requirement be extended to imports, as this is the only reliable guarantee of an animal's origin and an indispensable tool for managing health risks.

1.1.7 The EESC reiterates that the legislation applicable in the EU must also apply to imported animals so that our farmers are not placed at a disadvantage compared to farmers in third countries.

1.1.8 The EESC considers that cloning could pose a threat to quality production and the sustainability of Europe's economic and agri-food sector. Moreover, widespread cloning for agricultural purposes risks transferring wealth from workers and producers to the research centres that hold the patents.

1.2 Marketing of food from animal clones

1.2.1 The EESC believes it is necessary and appropriate to establish unambiguous provisions on temporarily prohibiting food from animal clones from being placed on the market, in order to take into account the different perceptions of citizens and of consumer organisations.

1.2.2 The EESC supports the temporary suspension of the marketing of food from animal clones in the EU to complement the temporary ban on the technique of animal cloning.

1.2.3 The EESC believes that the ban could be reviewed in future, taking into account the experience that Member States gain in implementing the legislation, scientific and technical progress and the development of the international environment, as well as the opinion of the public and of consumer organisations.

1.2.4 The EESC stresses that, given that animal cloning is permitted in certain non-EU countries, the Member States must adopt all appropriate measures to prevent foods obtained in third countries from animal clones being imported into the EU.

1.2.5 The EESC is concerned at the lack of adequate systems for detecting the existence of meat and milk from cloned animals in food imported from third countries; in this connection it demands that the full traceability requirement be extended to imports, as this is the only reliable guarantee of an animal's origin and an indispensable tool for managing health risks.

1.2.6 Recognising the need to safeguard consumer confidence and given the lack of sufficiently accurate analytical instruments to distinguish between clones and their offspring and conventionally-bred animals, and of clear and reliable traceability and labelling systems, the Committee warns of possible future negative repercussions on the market in animal products.

1.3 Novel foods

1.3.1 The EESC considers an update of legislation on novel foods to be necessary and appropriate, as this would achieve both greater legal certainty and greater food safety, and it therefore endorses the Commission proposal, although a number of suggestions should be taken into account.

1.3.2 The EESC believes that the status of novel food, based on the fact that the food ‘was not used for human consumption to a significant degree within the Union’, should be defined more precisely, and appropriate requirements established.

1.3.3 The EESC considers that the implications of the generic authorisation model envisaged in the proposal should be carefully explored, as on no account must it be allowed to jeopardise future innovation.

1.3.4 The EESC considers that the procedure for authorising traditional foods from third countries should be simpler and based on clear criteria that can provide evidence of the ‘history of safe food use in a third country’ referred to in the proposal.

1.3.5 The EESC believes that Union lists should be clear, up-to-date and easily accessed by both consumers and operators. Lists should include, as well as authorised traditional foods from third countries and novel foods, cases where authorisation has been denied along with the reasons for this rejection of the application. This will encourage transparency and ensure the necessary legal certainty.

1.3.6 The EESC notes that no system or timeframe is envisaged for review of the list, and therefore proposes that the same regulation establish a mechanism for reviewing the list when necessary.

1.3.7 It considers that businesses' efforts in the field of R+D+I should be safeguarded by the authorities through adequate data protection. It therefore suggests that the conditions for this protection be related to the applicant rather than to the Commission's opinion of the application.

1.3.8 The EESC would like to make it clear that the transitional measures should also cater for products that do not comply with the requirements laid down by the regulation on the date of its entry into force.

2. Gist of the proposals

2.1 Cloning

2.1.1 The proposal lays down rules for the cloning of animals for farming purposes in the EU and the placing on the market of embryo clones and animal clones.

2.1.2 To this end, the following definitions apply: (a) animals ‘kept and reproduced for farming purposes’ means animals kept and reproduced for the production of food, wool, skin or fur or for other farming purposes. It shall not include animals kept and reproduced exclusively for other purposes such as research, the production of medicinal products and medical devices, the preservation of rare breeds or endangered species, sporting and cultural events; (b) ‘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 clone’); (c) ‘placing on the market’ means the first making available of an animal or a product on the internal market.

2.1.3 Member States are to provisionally prohibit the cloning of animals and the placing on the market of animal clones and embryo clones.

2.1.4 Animals kept and reproduced exclusively for other purposes such as research, the production of medicinal products and medical devices, the preservation of rare breeds or endangered species, and sporting and cultural events are explicitly excluded.

2.1.5 Member States are to lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to the directive.

2.2 Marketing of food from animal clones

2.2.1 The proposal addresses consumer perceptions on the use of food from animal clones.

2.2.2 It provides for provisional prohibition of the placing on the market of food from animal clones.

2.2.3 in which: (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 clone’); (b) ‘food’ means food as defined in Article 2 of Regulation (EC) No 178/2002.

2.2.4 Importing of food of animal origin from third countries where food from animal clones can be legally placed on the market or exported is prohibited unless all the specific import conditions are met.

2.2.5 The proposal ensures that food such as meat or milk from clones is not placed on the EU market.

2.2.6 Member States are to lay down rules on penalties applicable to infringements of the national provisions adopted pursuant to the directive.

2.3 Novel foods

2.3.1 The original European regulation dates from 1997 and is updated by this proposal.

2.3.2 This proposal aims to ensure food safety, to protect public health and secure the functioning of the internal market, while contributing to innovation in the food sector.

2.3.3 It aims to streamline the authorisation procedure and improve its efficiency and transparency. It also clarifies the definition of a novel food and takes into consideration new technologies which have an impact on food.

2.3.4 It introduces a faster and more proportionate safety assessment for traditional foods from third countries having a history of safe food use.

2.3.5 It keeps the existing general criteria for defining novel food: ‘(a) food that was not used for human consumption to a significant degree within the Community before 15 May 1997, including, in particular; (i) food to which a new production process not used for food production within the Union before 15 May 1997 is applied, where that production process gives rise to significant changes in the composition or structure of the food which affect its nutritional value, the way it is metabolised or the level of undesirable substances; (ii) food containing or consisting of “engineered nanomaterials” as defined in Article 2(2)(t) of Regulation (EU) No 1169/2011; (iii) vitamins, minerals and other substances used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013, where: a new production process has been applied as referred to in point (i) of this paragraph; or such substances contain or consist of “engineered nanomaterials”; (iv) food used exclusively in food supplements within the Union before 15 May 1997, where it is intended to be used in foods other than food supplements as defined in point (a) of Article 2 of Directive 2002/46/EC.’

2.3.6 The proposal also contains definitions of basic concepts such as ‘traditional food from a third country’ and ‘history of safe food use’.

2.3.7 Novel foods are to be subject to safety evaluation and authorisation via a fully harmonised procedure.

2.3.8 The proposal stipulates that only novel foods included in the Union list of novel foods may be placed on the market in the EU, and only if they meet the following conditions: — they do not, on the basis of the scientific evidence available, pose a safety concern; — they do not mislead the consumer; — they are not nutritionally disadvantageous for the consumer in cases where they are intended to replace a traditional food.

2.3.9 The current system of individual authorisations is replaced by a system of generic authorisations.

2.3.10 All applications for the authorisation of novel foods are to be submitted to the Commission, who will then request a scientific opinion on risk assessment from the European Food Safety Authority (EFSA). The Commission will consider the inclusion of a novel food in the Union list of novel foods on the basis of this opinion, and will be assisted in this task by the Standing Committee on the Food Chain and Animal Health (SCOFCAH).

2.3.11 For traditional foods from third countries, a safety assessment and risk management based on a history of safe food use in a third country for at least 25 years will be introduced.

2.3.12 Where reasoned objections are presented concerning the safety of a traditional food from a third country, an EFSA assessment, followed by an EU authorisation procedure similar to the general procedure but with shorter deadlines, will be required. On the basis of the EFSA opinion, the Commission may impose post-market monitoring where necessary for food safety reasons.

2.3.13 The proposal provides for the right to data protection for a maximum of five years, in duly justified cases.

2.3.14 Member States are to lay down the rules on penalties applicable to infringements of the national provisions adopted pursuant to the regulation.

3. General comments

3.1 Cloning

3.1.1 The EESC supports the proposal, taking note of the insufficient technical and scientific knowledge available, the problems relating to animal welfare and the opposition of the public and of consumers, although it considers that the temporary ban on cloning animals will, in due time, need to be reviewed to take into account improvements in the technique, scientific progress, the international environment and the need for the sectors involved to be competitive.

3.1.2 The EESC points out that Member States have undertaken ‘to ensure that the owners or keepers take all reasonable steps to ensure the welfare of animals under their care and to ensure that those animals are not caused any unnecessary pain, suffering or injury’ (1).

3.1.3 The EESC believes it is extremely important to highlight the decisive role of the EFSA in assessing the potential risks associated with using the technique of animal cloning and its contribution to decisions relating to the use of the technique.

3.1.4 The EFSA has encountered animal welfare problems arising from the health of the surrogate mothers and of the clones themselves (high rate of miscarriages, dysfunctions of the placenta, implants in several surrogate mothers in order to obtain a clone, unusually large size of foetuses and stillbirths), making cloning a technique with a high mortality rate.

3.1.5 Cloning presents risks to biodiversity and the genetic heritage, which will create problems in terms of resistance to emerging risks and new zoonotic agents entering Europe (e.g. Schmallenberg virus).

3.1.6 The EESC considers that cloning could pose a threat to quality production and the sustainability of Europe's economic and agri-food sector. Moreover, widespread cloning for agricultural purposes risks transferring wealth from workers and producers to the research centres that hold the patents.

3.2 Marketing of food from animal clones

3.2.1 The EESC welcomes the proposal, taking note of the insufficient technical and scientific knowledge available, the problems relating to animal welfare and the opposition of the public and of consumer organisations, although it considers that the temporary ban on the placing on the market of food from animal clones will need to be reviewed to take into account improvements in the technique, scientific progress, the international environment and the need for the sectors involved to be competitive.

3.2.2 Recognising the need to safeguard consumer confidence and given the lack of sufficiently accurate analytical instruments to distinguish between clones and their offspring and conventionally-bred animals, and of clear and reliable traceability and labelling systems, the Committee warns of possible future negative repercussions on the market in animal products.

3.2.3 The EESC points out that no application has ever been submitted for an authorisation to market food produced by means of cloning techniques.

3.2.4 The EESC highlights the role of the EFSA in assessing the potential risks associated with using the technique of cloning.

3.2.5 The EESC stresses that there was no indication in the ESFA's assessments of any difference in food safety between meat and milk from clones and their progeny and that from conventionally-bred animals.

3.2.6 The ban on the marketing of food from animal clones is not based on known health risks but on ethics and animal welfare.

3.3 Novel foods

3.3.1 The EESC welcomes the proposal to revise the current legislation on novel foods, given that it dates from 1997 and significant innovation has taken place in the past 17 years.

3.3.2 The EESC stresses that the proposal must be clear and comprehensive enough for operators to be able to implement it.

3.3.3 The EESC considers that it is necessary and appropriate to establish a centralised authorisation procedure and a harmonised system of penalties in order to make progress with the single market.

3.3.4 It congratulates the Commission on giving the EFSA a key role in assessing the risk presented by novel foods, which will benefit the safety and protection of consumers and the industry itself.

3.3.5 The EESC considers that the concept of food ‘used for human consumption to a significant degree’ is not sufficiently clear.

3.3.6 It notes the need to establish clear criteria that can provide evidence of the ‘history of safe food use in a third country’, which is a pre-requisite for authorising traditional foods from third countries.

3.3.7 The EESC has concerns regarding the confidentiality of the data that the applicant submits to obtain authorisation of a novel food.

3.3.8 It feels that the transitional measures provided for in the proposal need to be further developed and clarified.

3.3.9 The EESC believes it is important for the Commission to be assisted by the SCOFCAH.

4. Specific comments

4.1 Cloning

4.1.1 Cloning is not a technique that is currently in use in the EU for farming purposes.

4.1.2 However, it is used in countries such as Argentina, Brazil, Canada and the USA, although these countries have not been able to specify the extent of production of cloned animals.

4.1.3 EU citizens have expressed a broadly negative opinion on the use of the cloning technique for reproduction for farming purposes.

4.1.4 Since the proposal provides for the provisional prohibition of animal cloning and placing on the market of animals and clones from embryos in the EU, the Member States must adopt the necessary sampling and monitoring measures to enforce the provision.

4.1.5 As yet no endorsed, accredited and harmonised analytical methodology exists in this field. We therefore feel it is necessary for the Commission and the Member States to start work on this aspect.

4.1.6 The EESC also calls on the Member States to harmonise their rules on penalties applicable in the event of infringement, in order to avoid some countries becoming more permissive or lenient and the ensuing downward competition among them.

4.2 Marketing of food from animal clones

4.2.1 Since the proposal provides for the provisional prohibition of animal cloning and placing on the market of animals and clones from embryos in the EU, the Member States must adopt the necessary sampling and monitoring measures to enforce the provision.

4.2.2 As yet no endorsed, accredited and harmonised analytical methodology exists in this field. We therefore feel it is necessary for the Commission and the Member States to start work on this aspect.

4.3 Novel foods

4.3.1 Definition of novel food

The EESC considers that the proposal's definition of novel food is based on consumption, and that it should be more precise in order to avoid food products that are not novel foods (e.g. pizza with new ingredients) being included.

4.3.2 Concept of significant change

The EESC notes that the criteria for establishing what is meant by ‘significant change’ should be set out in detail, so as to be able to determine whether a novel food falls within the scope of the proposal.

4.3.3 Concept of ‘human consumption to a significant degree’

The EESC is concerned by the concept of ‘human consumption to a significant degree’ because of its ambiguity (within a region?, country?, geographical area?, in a specific community?).

4.3.4 Centralised authorisation procedure

In a previous opinion (2) which is essentially still valid, the EESC pointed out in this connection: ‘Centralising the assessment and authorisation of novel foods (involving the EFSA and the European Commission) is essential, but a simple, clear, effective, detailed procedure with deadlines also needs to be established ...’.

Although the proposal specifies some timeframes (e.g. nine months for the EFSA to issue its opinion, another nine months for the Commission to adopt the corresponding implementing act to authorise a novel food), greater clarity and precision are needed so that the operator is aware of the details of where the application submitted is the process.

4.3.5 Lists

In the same opinion the EESC commented with regard to lists: ‘The initiative to draw up lists of novel foods (...) will help to improve consumer information and provide operators with greater legal certainty. The list-based model is by no means new, since the use of such lists has become increasingly common (for example, the Regulation on nutrition and health claims and the Regulation on the addition of vitamins and minerals to foods, amongst others)’.

This comment still applies, notwithstanding the fact that only one list is currently being proposed by the Commission rather than two separate lists.

4.3.6 Protection of intellectual property

In the above opinion the EESC stated: ‘Developing novel foods requires considerable commitment to and investment in R&D on the part of businesses and they therefore require not only straightforward, swift and economically feasible procedures; knowledge and developments must also be protected to ensure that competitiveness does not suffer. No clear definition is provided for the scope of the data protection to which, according to the proposal, businesses will be entitled (it refers only to authorisations, what becomes of applications that are ultimately rejected, etc.)’.

The opinion goes on to say: ‘Providing the future regulation with a tool such as data protection will help to give businesses some security as regards the economic and human resources they channel into new projects. They will see data protection as a tool that affords them the protection they need to continue innovating and to become increasingly competitive, given the ever-more demanding nature of both the market and consumers’.

These comments continue to apply.

Brussels, 30 April 2014. The President of the European Economic and Social Committee Henri MALOSSE

(1) Council Directive 98/58/EC (Article 3).

(2) OJ C 224, 30.8.2008, p.81.