# Official Journal C 274/2021

| | ISSN 1977-091X |
| --- | --- |
| Official Journal
  of the European Union | C 274 |
| | |
| English edition | Information and Notices | Volume 649 July 2021 |

ISSN 1977-091X

Official Journal

of the European Union

C 274

English edition

Information and Notices

Volume 649 July 2021

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| Contents | page |
| --- | --- |
| | II   Information |
| | INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2021/C 274/01 | Communication from the Commission on the European Citizens’ Initiative (ECI) End the Cage Age | 1 |
| 2021/C 274/02 | Commission Notice on marketing authorisations for veterinary medicinal products for which the expiry of the 5-year period of validity falls on or after the date of entry into application of Regulation (EU) 2019/6 | 14 |
| 2021/C 274/03 | Initiation of proceedings (Case M.10078 — Cargotec/Konecranes) (
  1
  ) | 17 |

Contents

page

II   Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2021/C 274/01

Communication from the Commission on the European Citizens’ Initiative (ECI) End the Cage Age

1

2021/C 274/02

Commission Notice on marketing authorisations for veterinary medicinal products for which the expiry of the 5-year period of validity falls on or after the date of entry into application of Regulation (EU) 2019/6

14

2021/C 274/03

Initiation of proceedings (Case M.10078 — Cargotec/Konecranes) (
  1
  )

1

17

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| | IV   Notices |
| --- | --- |
| | NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
| | European Commission |
| 2021/C 274/04 | Euro exchange rates — 8 July 2021 | 18 |

IV   Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

2021/C 274/04

Euro exchange rates — 8 July 2021

18

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| | V   Announcements |
| --- | --- |
| | PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY |
| | European Commission |
| 2021/C 274/05 | Prior notification of a concentration (Case M.10345 — Equistone Partners Europe/CVG) – Candidate case for simplified procedure (
  1
  ) | 19 |

V   Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

2021/C 274/05

Prior notification of a concentration (Case M.10345 — Equistone Partners Europe/CVG) – Candidate case for simplified procedure (
  1
  )

1

19

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| | (1)   Text with EEA relevance. |

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(1)   Text with EEA relevance.

1

| EN | |
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EN

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II Information

INFORMATION FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 9.7.2021 | EN | Official Journal of the European Union | C 274/1 |
| --- | --- | --- | --- |

9.7.2021

EN

Official Journal of the European Union

C 274/1

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Communication from the Commission on the European Citizens’ Initiative (ECI) ‘End the Cage Age’

(2021/C 274/01)

1.   INTRODUCTION: THE CITIZENS’ INITIATIVE

By means of a European citizens’ initiative (ECI) under Article 11(4) of the Treaty on European Union, a million or more nationals of a significant number of EU Member States can ask the European Commission, within the scope of its powers, to submit an appropriate proposal on a matter on which they consider that an EU legal act is required for the purpose of implementing the Treaties. Detailed rules on ECIs are set out in Regulation (EU) 2019/788 (1) (the ECI Regulation).

‘End the Cage Age’ is the sixth ECI to have reached the numerical thresholds (2). It calls on the Commission to take action on the treatment of farm animals, as follows:

‘Hundreds of millions of EU farm animals are kept in cages for most of their lives, causing great suffering. We call on the European Commission to end this inhumane treatment of farm animals.

Cages inflict suffering on enormous numbers of farm animals every year. They are cruel and unnecessary, as higher-welfare cage-free systems are viable.

The Commission is therefore invited to propose legislation to prohibit the use of:

| — | cages for laying hens, rabbits, pullets, broiler breeders, layer breeders, quail, ducks and geese; |
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cages for laying hens, rabbits, pullets, broiler breeders, layer breeders, quail, ducks and geese;

| — | farrowing crates for sows; |
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farrowing crates for sows;

| — | sow stalls, where not already prohibited; |
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sow stalls, where not already prohibited;

| — | individual calf pens, where not already prohibited.’ (3) |
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individual calf pens, where not already prohibited.’ (3)

The organisers explained the objectives of the initiative in detail in a meeting with the Commission on 30 October 2020 and a public hearing organised by the European Parliament on 15 April 2021. On 10 June 2021, the European Parliament held a plenary debate on this citizens’ initiative and adopted a resolution (4) setting out the Parliament’s position.

This Communication sets out the Commission’s legal and political assessment of the initiative, the action it intends to take, its reasons for doing so and the envisaged timeline, in accordance with Article 15(2) of the ECI Regulation.

2.   CONTEXT

This citizens’ initiative reflects a demand for a transition to more ethical and sustainable farming systems, to be achieved inter alia on the basis of new animal welfare legislation. Responding to this demand is a high priority for the Commission, as it has made clear in the European Green Deal (5) and the Farm to Fork Strategy (6). The initiative claims that 300 million animals are currently kept in cages in the EU.

The Treaty on the Functioning of the European Union defines animals as sentient beings. As a major importer of food, the EU has a moral responsibility to ensure that on-farm conditions for animals reflect its principles, including in respect of the food that it imports.

The phasing-out of cages started 22 years ago, when new legislation for the rearing of laying hens entered into force. Scientific analysis supported the benefits of this approach for other species such as calves and pigs, for which partial prohibitions were introduced in 1997 and 2001 respectively.

2.1.   Existing legal framework for on-farm animal welfare

EU legislation on animal welfare has evolved and expanded its coverage since the first EU legislation on the welfare of animals was adopted in 1974. The current legal framework for the keeping of farmed animals consists of a general Directive (7) on the protection of animals bred and kept for farming purposes. It sets out general principles and leaves room for Member States to adopt stricter provisions, provided they are compatible with EU rules. To complement the general Directive, four sector-specific Directives govern the welfare of laying hens, broilers, calves and pigs.

The general Directive provides that the freedom of movement of animals must not be restricted in such a way as to cause them unnecessary suffering or injury. In addition, it requires that, where an animal is continuously or regularly tethered or confined, it must be given appropriate space in line with its physiological and ethological needs. Keeping animals in cages is thus allowed, but subject to certain conditions.

The sector-specific Directives lay down certain rules on confinement:

| — | for laying hens, the legislation for the rearing of laying hens adopted in 1999 prohibited the use of barren (‘battery’) cages in the EU, with a 2 stage transitional period of 12 years in total: as from 2003 cages taken into use for the first time had to be enriched cages, and as from 2012 the prohibition on barren cages for laying hens applied to all farms in the EU. Today, laying hens may be kept in ‘enriched’ cages that allow them to perch and scratch, for example (8); |
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for laying hens, the legislation for the rearing of laying hens adopted in 1999 prohibited the use of barren (‘battery’) cages in the EU, with a 2 stage transitional period of 12 years in total: as from 2003 cages taken into use for the first time had to be enriched cages, and as from 2012 the prohibition on barren cages for laying hens applied to all farms in the EU. Today, laying hens may be kept in ‘enriched’ cages that allow them to perch and scratch, for example (8);

| — | since 2013, it has been obligatory to keep female pigs (sows) in groups for a period starting from 4 weeks after service (mating with a boar or insemination) to 1 week before the expected time of farrowing. For the rest of the time (i.e. from 1 week before the expected time of farrowing to 4 weeks after service), in line with applicable EU legislation, a large proportion of gilts and sows in the EU are regularly confined in ‘farrowing crates’ and ‘sow stalls’ (9); and |
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since 2013, it has been obligatory to keep female pigs (sows) in groups for a period starting from 4 weeks after service (mating with a boar or insemination) to 1 week before the expected time of farrowing. For the rest of the time (i.e. from 1 week before the expected time of farrowing to 4 weeks after service), in line with applicable EU legislation, a large proportion of gilts and sows in the EU are regularly confined in ‘farrowing crates’ and ‘sow stalls’ (9); and

| — | since 2007, it has not been allowed to confine a calf in an individual pen after the age of 8 weeks. However, up to that age, the individual keeping of calves is possible, subject to the conditions of the applicable EU legislation (10). |
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since 2007, it has not been allowed to confine a calf in an individual pen after the age of 8 weeks. However, up to that age, the individual keeping of calves is possible, subject to the conditions of the applicable EU legislation (10).

No specific EU animal welfare legislation exists for the other animals referred to in the European citizens’ initiative.

The request to phase out cages is in line with current developments, as several Member States have already implemented total or partial bans on cages:

Enriched cages for laying hens:

| — | banned in Austria and Luxembourg; |
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banned in Austria and Luxembourg;

| — | banned in France for new or refurbished farms; |
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banned in France for new or refurbished farms;

| — | banned in Germany from 2025, in Czechia from 2027, in Wallonia (Belgium) from 2028 and in Slovakia from 2030. |
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banned in Germany from 2025, in Czechia from 2027, in Wallonia (Belgium) from 2028 and in Slovakia from 2030.

Sow stalls and farrowing crates:

| — | banned in Sweden; |
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banned in Sweden;

| — | farrowing crates allowed for max. 5 days per farrowing period in Germany by 2036; |
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farrowing crates allowed for max. 5 days per farrowing period in Germany by 2036;

| — | ban of sow stalls by 2029 in Germany; |
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ban of sow stalls by 2029 in Germany;

| — | ban of sow stalls from the time of weaning in Denmark with full effect from 2035; |
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ban of sow stalls from the time of weaning in Denmark with full effect from 2035;

| — | ban of sow stalls 4 days after insemination in the Netherlands and 10 days after insemination in Austria. |
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ban of sow stalls 4 days after insemination in the Netherlands and 10 days after insemination in Austria.

Cages for rabbits:

| — | banned for meat rabbits in Austria, Germany and the Netherlands; |
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banned for meat rabbits in Austria, Germany and the Netherlands;

| — | ban on barren cages for meat rabbits since 2016 and enriched cages for meat rabbits and breeding females in Flanders (Belgium) from 2025; |
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ban on barren cages for meat rabbits since 2016 and enriched cages for meat rabbits and breeding females in Flanders (Belgium) from 2025;

| — | specific requirements for rabbits in Germany, the Netherlands and Sweden, e.g. housing at least in pairs (fattening rabbits), suitable gnawing material, access to roughage, access to a platform. |
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specific requirements for rabbits in Germany, the Netherlands and Sweden, e.g. housing at least in pairs (fattening rabbits), suitable gnawing material, access to roughage, access to a platform.

2.2.   Current EU policy context

On 11 December 2019, the Commission adopted a Communication on A European Green Deal (11), a comprehensive strategy to transform the EU into a modern, resource-efficient and competitive economy that caters for all dimensions of sustainability, including animal welfare.

On 20 May 2020 (as part of the Green Deal), the Commission adopted the Farm to Fork Strategy (12), which sets out a blueprint for a fair, healthy and environment-friendly food system. Through the strategy, the Commission seeks to ensure not only that food in the EU is safe, nutritious and of high quality, but also that it becomes the global standard for sustainability. Animal welfare plays a prominent role in the sustainability agenda and the strategy includes a commitment of the Commission to submit legislative proposals to revise EU animal welfare legislation by the end of 2023, following an evaluation (fitness check) of the existing legislation and an impact assessment. The aim is to improve animal welfare, broaden the scope of the legislation, align it with the latest scientific evidence and make it easier to enforce.

The Commission also announced in the strategy that it would:

| — | look at options for animal welfare labelling, in order better to reap and transfer along the food chain the added value that products gain through welfare-friendly practices; and |
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look at options for animal welfare labelling, in order better to reap and transfer along the food chain the added value that products gain through welfare-friendly practices; and

| — | propose a sustainable food-labelling framework. |
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propose a sustainable food-labelling framework.

The Farm to Fork Strategy recognises the role of the common agricultural policy (CAP) in supporting the transition to sustainable food systems. In the context of and subject to the ongoing legislative procedure regarding the CAP, a new system, is envisaged from 2023 whereby Member States will be able to use ‘eco-schemes’ (13) to support a transition to better animal welfare (14). Eco-schemes will provide farmers with support in the form of management commitments compensating them for additional costs or income losses associated with upgraded standards that go beyond mandatory requirements. Eco-schemes are fully financed by the general budget of the Union.

Under the European Agricultural Fund for Rural Development (EAFRD), the same possibilities will continue to be available for supporting animal welfare after 2022 as were available under the CAP from 2014 to 2022. EAFRD-funded projects (‘interventions’) require co-financing by Member States. EAFRD support is available in the form of management commitments compensating farmers for additional costs or income losses associated with commitments for upgraded standards that go beyond mandatory requirements, and investments for more animal welfare friendly housing. The extent to which EAFRD and eco-scheme support goes to animal welfare depends on Member States’ needs and prioritising.

Further intervention possibilities under EAFRD and eco-schemes include support for:

| — | training and advice; |
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training and advice;

| — | converting to and maintaining organic farming methods; |
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converting to and maintaining organic farming methods;

| — | quality schemes; and |
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quality schemes; and

| — | cooperation and innovation between food chain operators under the European Innovation Partnership for Agricultural Productivity and Sustainability (EIP-AGRI) (15). |
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cooperation and innovation between food chain operators under the European Innovation Partnership for Agricultural Productivity and Sustainability (EIP-AGRI) (15).

It is envisaged that animal welfare will be one of the CAP’s specific objectives for the 2023-2027 period (16). Each Member State will assess its situation on the basis of a SWOT analysis (strengths, weaknesses, opportunities and threats) and its specific needs, in particular as regards improving animal welfare and reducing the use of antimicrobials. On this basis, each Member State will design interventions to be included in a CAP national strategic plan (which will be operative as of the beginning of 2023 after their approval by the Commission), which will also set out a strategy for combining various CAP tools. Dedicated indicators will be used to measure and monitor progress in implementing the plans.

Compliance with mandatory existing animal welfare legal requirements (17) will continue to be one of the conditions for farmers to receive full CAP direct support and certain (annual) payments under the EAFRD, including animal welfare payments.

The Commission adopted recommendations in respect of the CAP national strategic plans in December 2020. These recommendations, specifically addressed to each Member State, include a number of measures enhancing the welfare of farm animals (18).

To help Member States formulate interventions in line with the recommendations, the Commission recently launched a study on CAP measures and instruments that promote animal welfare and the reduction of antimicrobial use (19). It is expected to be concluded in October 2021.

2.3.   Scientific context and ongoing projects

Better animal welfare is not only an ethical issue, it improves animal health and reduces the need for medication, thus slowing the possible triggering of antimicrobial-resistant micro-organisms and improving food quality. In addition, reducing stress in laying hens, for example, reduces the prevalence of Salmonella in flocks. The welfare of humans and the welfare of animals are closely linked.

Over the past 20 years, the European Food Safety Authority (EFSA), the Commission’s main scientific advisor in this area, has adopted opinions addressing (among others) the welfare of laying hens and pigs. Currently, EFSA is developing further scientific assessments on cages for the species and categories of animals covered by the citizens’ initiative. These will be available in 2022 and 2023. A recent EFSA opinion can be considered as reflecting the current state of knowledge as regards rabbits (20).

Recently published scientific studies attest the existence of alternative high-performing farming systems that do not entail the use of cages. In addition, a recent study produced for the European Parliament’s Committee on Petitions (PETI) (21) concludes that non-caged systems for laying hens are economically, environmentally and socially similar to furnished cage systems. Another study (22) provides an overview of scientific research on the caged farming of laying hens, sows, rabbits, ducks, geese, calves and quail. It describes the welfare impacts of caged confinement and of housing in alternative farming systems. Other reports outline the environmental and welfare challenges, opportunities and potential consequences of further animal welfare improvements and ending the use of cages in the production of certain farmed animals in the EU (23).

Various ongoing research and innovation projects, also financed by the EU, are looking at animal welfare, in particular low-input (24) and organic farming, precision farming (25) and welfare-friendlier practices in intensive farming. While no projects to date have looked specifically at the withdrawal of cages, some CORE (26) Organic Cofund (27) projects funded from Horizon 2020, are looking at animal rearing, allowing animals to meet their natural requirements and related issues; these include:

| — | POWER, which is investigating the combined improvement of the housing and management of pigs, including the effects of farrowing pen design, sow genetics and management strategies on newborn piglet mortality and piglet health before and after weaning; and |
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POWER, which is investigating the combined improvement of the housing and management of pigs, including the effects of farrowing pen design, sow genetics and management strategies on newborn piglet mortality and piglet health before and after weaning; and

| — | GroupHouseNet (28), a COST action that aims to provide the EU livestock industry with the innovations in breeding and management for pigs and poultry that it needs for a successful transition to large group housing systems without the need for painful tail docking and beak trimming. |
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GroupHouseNet (28), a COST action that aims to provide the EU livestock industry with the innovations in breeding and management for pigs and poultry that it needs for a successful transition to large group housing systems without the need for painful tail docking and beak trimming.

Horizon Europe, the EU’s new framework programme for research and innovation, will provide further support in 2021-2027, in particular in the ‘agriculture, forestry and rural areas’ intervention area (29).

2.4.   Social and economic context

Growing numbers of consumers are demanding more welfare-friendly farming methods and information to help them identify products produced in welfare-friendly conditions (30).

Farmed animals are kept in caged confinement for various, mainly economic reasons. Such systems (particularly in intensive production units) are economically efficient and provide more practical working conditions. Some degree of indoor confinement may also be necessary for biosecurity reasons, to prevent certain animal diseases.

Discontinuing the use of cages will necessitate changes to current farming systems and often costly investments. It may require farmers to adjust farm premises, purchase new equipment and adapt production and husbandry practices. At the same time, the switch to farming systems with higher animal welfare standards often improves farmers’ reputation in society and raises confidence in their work (31). The EU’s high animal welfare standards also contribute to the good reputation of EU agricultural products and partly explain the high demand for them, which ensures a better income for the farmers. Changes to current farming systems would also help to preserve the resources on which the food systems depend, which in turn would decrease the loss of biodiversity.

2.5.   Ongoing initiatives and actions relevant in the context of the citizens’ initiative

In view of the revision of the animal welfare legislation, including Directive 98/58/EC on the protection of animals kept for farming purposes (32), as announced under the Farm to Fork Strategy, the Commission is already taking or has already taken the following action:

| — | In June 2020, it mandated EFSA to provide updated scientific opinions on the advantages and disadvantages of different production systems and how they could be improved for species currently covered by sector-specific animal welfare legislation, i.e. laying hens (the mandate also includes pullets and layer breeders), chickens kept for meat production (also including broiler breeders), calves and pigs. In June 2021, it requested further opinions on animal welfare aspects of cage and cage-free farming of quail, ducks and geese (33). EFSA is expected to issue these opinions in 2022 and 2023; |
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In June 2020, it mandated EFSA to provide updated scientific opinions on the advantages and disadvantages of different production systems and how they could be improved for species currently covered by sector-specific animal welfare legislation, i.e. laying hens (the mandate also includes pullets and layer breeders), chickens kept for meat production (also including broiler breeders), calves and pigs. In June 2021, it requested further opinions on animal welfare aspects of cage and cage-free farming of quail, ducks and geese (33). EFSA is expected to issue these opinions in 2022 and 2023;

| — | On 7 April 2021, the Commission published the results of an evaluation of the EU’s 2012-2015 animal welfare strategy (34); |
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On 7 April 2021, the Commission published the results of an evaluation of the EU’s 2012-2015 animal welfare strategy (34);

| — | It is currently carrying out an evaluation (fitness check) of the EU animal welfare acquis (35), which seeks to identify:






  — | possible shortcomings in the design, scope and implementation of the existing rules; |
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It is currently carrying out an evaluation (fitness check) of the EU animal welfare acquis (35), which seeks to identify:

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possible shortcomings in the design, scope and implementation of the existing rules;

| — | potential for simplification and reducing regulatory costs and burdens; and |
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potential for simplification and reducing regulatory costs and burdens; and

| — | possible gaps and areas for improvement. |
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possible gaps and areas for improvement.

It expects to finalise the fitness check by 2022;

| — | It is exploring options for an EU-wide animal welfare label to improve the transmission of value through the food chain. To this end, it has established a dedicated subgroup of the EU Animal Welfare Platform and launched a study on animal welfare labelling (36); |
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It is exploring options for an EU-wide animal welfare label to improve the transmission of value through the food chain. To this end, it has established a dedicated subgroup of the EU Animal Welfare Platform and launched a study on animal welfare labelling (36);

In addition, the following ongoing and planned actions are relevant in the context of the citizens’ initiative:

| — | Studies to gather data on the environmental and socio-economic consequences of phasing out cages and to get a clearer picture on the current situation in the EU (37); |
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Studies to gather data on the environmental and socio-economic consequences of phasing out cages and to get a clearer picture on the current situation in the EU (37);

| — | A code of conduct for responsible business and marketing practices is currently under preparation. The goal is to encourage actors along the food chain to make sustainability commitments that also cover animal welfare; these could include commitments concerning the transition to non-caged systems; |
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A code of conduct for responsible business and marketing practices is currently under preparation. The goal is to encourage actors along the food chain to make sustainability commitments that also cover animal welfare; these could include commitments concerning the transition to non-caged systems;

| — | The Commission will prepare a legislative proposal for a framework for a sustainable food system before the end of 2023. Animal welfare will feature in discussions on the definition of food system sustainability and the criteria for assessing the sustainability of foods and operations; |
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The Commission will prepare a legislative proposal for a framework for a sustainable food system before the end of 2023. Animal welfare will feature in discussions on the definition of food system sustainability and the criteria for assessing the sustainability of foods and operations;

| — | By 2024, it will propose a sustainable food labelling framework that should cover the nutritional, climate, environmental and social aspects of food products, including animal welfare; |
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By 2024, it will propose a sustainable food labelling framework that should cover the nutritional, climate, environmental and social aspects of food products, including animal welfare;

| — | While several bilateral trade agreements with non-EU countries already include cooperation provisions on animal welfare, the EU will propose the inclusion of a chapter on sustainable food production systems in ongoing negotiations for free trade agreements with partner countries and future trade agreements. This also covers cooperation on animal welfare; and |
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While several bilateral trade agreements with non-EU countries already include cooperation provisions on animal welfare, the EU will propose the inclusion of a chapter on sustainable food production systems in ongoing negotiations for free trade agreements with partner countries and future trade agreements. This also covers cooperation on animal welfare; and

| — | The EU also promotes its animal welfare standards by contributing to the development, adoption and implementation of World Organisation for Animal Health (OIE) international standards on animal welfare (38) and cooperating with the Food and Agriculture Organization (FAO). |
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The EU also promotes its animal welfare standards by contributing to the development, adoption and implementation of World Organisation for Animal Health (OIE) international standards on animal welfare (38) and cooperating with the Food and Agriculture Organization (FAO).

3.   EVALUATION OF THE PROPOSALS IN THE INITIATIVE

3.1.   Response to initiative: actions

The citizens’ initiative calls on the Commission to propose legislation prohibiting the use of:

| — | cages for laying hens, rabbits, pullets, broiler breeders, layer breeders, quail, ducks and geese; |
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cages for laying hens, rabbits, pullets, broiler breeders, layer breeders, quail, ducks and geese;

| — | farrowing crates for sows; |
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farrowing crates for sows;

| — | sow stalls, where not already prohibited; and |
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sow stalls, where not already prohibited; and

| — | individual calf pens, where not already prohibited. |
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individual calf pens, where not already prohibited.

In response to the initiative and to the demand for a transition to more ethical and sustainable farming systems, the Commission intends to propose to phase out and finally prohibit the use of such cage systems, for all these species and categories, under conditions (including the length of the transition period) to be determined based on EFSA opinions and an impact assessment. This will be included as one of the key objectives of the revision of animal welfare legislation that the Commission has committed to propose by the last quarter of 2023.

The Commission will consider the following aspects in the context of the revision process:

A.   animals currently covered by species-specific animal welfare legislation

The existing species-specific animal welfare legislation on laying hens, sows and calves will be revised under the Farm to Fork Strategy, with a Commission proposal to be presented by the last quarter of 2023. This legislation currently provides for prohibitions of certain types of cage, but not all.

B.   animals currently not covered by species-specific animal welfare legislation

Currently, there is no specific EU animal welfare legislation for several of the species/categories covered by the ECI (rabbits, pullets, broiler breeders, layer breeders, quail, ducks and geese).

In order to respond to the initiative, the Commission has, in June 2020 and in June 2021, mandated EFSA to complement existing scientific evidence on the animal welfare impacts of cage farming systems for laying hens, pigs, calves, pullets, broiler breeders, layer breeders, quail, ducks and geese in the course of 2022 and early 2023 with the aim to introduce the legislation by the last quarter of 2023.

The conditions for the prohibition of cage systems will be determined on the basis of an impact assessment; they will take account of:

| — | animal welfare benefits; |
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animal welfare benefits;

| — | the social and economic needs of the farming sector in the EU, including of small farms; |
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the social and economic needs of the farming sector in the EU, including of small farms;

| — | the international trade dimension; and |
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the international trade dimension; and

| — | environmental aspects. |
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environmental aspects.

3.2.   Response to the initiative: envisaged timeline

The Commission’s response to the initiative as outlined in Chapter 3.1 will be included as one of the key objectives in the revision of animal welfare legislation that it has committed to propose by the last quarter of 2023.

To develop this legislative proposal, the Commission will prepare an impact assessment as described above. This assessment will also support decision-making – amongst others – on accompanying measures. It will include a public consultation that will be carried out by early 2022. The impact assessment is scheduled to be completed by the end of 2022.

While the citizens’ initiative does not include a specific request on timing, in the meeting with the Commission and the hearing in the European Parliament the organisers expressed their ambition for a ban on cages to come into effect in 2027.

The date of entry into force of the prohibition, and thus the length of the phasing out period, will be considered in the context of the impact assessment for the legislative proposal. In particular, this will assess the feasibility of working towards the proposed legislation entering into force from 2027 taking into account the need to support farmers in this transition – financially and otherwise.

3.3.   Transitional and accompanying actions in the EU

While the initiative itself does not include requests for transitional and accompanying measures, the organisers indicated at the meeting with the Commission and at the public hearing of the European Parliament that such measures would be needed to facilitate the transition to cage-free farming.

The Commission considers that a balanced transition to cage-free systems requires appropriate consideration of relevant societal concerns, the economic impacts on the various parties involved and environmental aspects. It should be organised and supported in such a way that farmers can seize society’s demand for enhanced animal welfare as an opportunity to contribute directly to better animal health and welfare, food quality and environmental objectives without however endangering the survival of their farms. The entire food chain, in particular the food processing industry and the retail sector, will have an important role to play.

Therefore, in parallel to the legislation it will propose, the Commission will continue to develop supporting measures, such as best practices, guidelines, recommendations and studies, for the promotion of and the transition to non-cage farming. It will promote communication and information on the measures, in the preparation of the phasing out of cages. This aims at providing incentives for farmers to start the transition process.

| — | With the CAP, the EU will provide financial support to farmers to shift to cage-free systems through means available under the rural development policy and the new eco-schemes (to the extent that Member States use these opportunities). The Commission encourages Member States to use the eco-schemes (once the legislation establishing the new CAP has been adopted) and to present their intervention strategies in their national strategic plans to support the phasing out of cages. This could also imply a shift to innovative solutions as well as extensive production systems. |
| --- | --- |

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With the CAP, the EU will provide financial support to farmers to shift to cage-free systems through means available under the rural development policy and the new eco-schemes (to the extent that Member States use these opportunities). The Commission encourages Member States to use the eco-schemes (once the legislation establishing the new CAP has been adopted) and to present their intervention strategies in their national strategic plans to support the phasing out of cages. This could also imply a shift to innovative solutions as well as extensive production systems.

When evaluating the Member States’ national strategic plans the Commission will pay particular attention to the financial support that Member States intend to devote to improve animal welfare. Finally, the Commission encourages Member State to increase the aid intensity (39) for EAFRD support for cage-free systems, as compared with investments in housing with less focus on animal welfare.

In its annual work programmes for the farm products promotion policy (40), the Commission will also include a dedicated budget for raising awareness of sustainability in agriculture, including specific animal welfare features such as cage-free farming systems.

Other supporting measures will complement CAP funding:

| — | In line with the adopted action plan on organic farming, aiming to ensure that 25 % of land in the EU is used for organic production by 2030, farmers will be provided with opportunities to switch from cage-systems directly to organic farming. The use of cages is not allowed in organic production (41); |
| --- | --- |

—

In line with the adopted action plan on organic farming, aiming to ensure that 25 % of land in the EU is used for organic production by 2030, farmers will be provided with opportunities to switch from cage-systems directly to organic farming. The use of cages is not allowed in organic production (41);

| — | The Commission will support farmers and other actors in the transition to cage-free systems through information campaigns and training through the Member States’ farm advisory services (42); |
| --- | --- |

—

The Commission will support farmers and other actors in the transition to cage-free systems through information campaigns and training through the Member States’ farm advisory services (42);

| — | The Commission will work closely with the food processing industry and retailers to encourage them to support the development of the market for cage-free products at rewarding farm gate prices; |
| --- | --- |

—

The Commission will work closely with the food processing industry and retailers to encourage them to support the development of the market for cage-free products at rewarding farm gate prices;

| — | In line with the Farm to Fork Strategy, the Commission will consider options for animal welfare labelling to improve the transmission of value through the food chain. A requirement to inform consumers whether products come from animals kept in cages or from cage-free systems could encourage farmers to switch earlier to cage-free systems and consumers to become more aware of their choices. Similarly, the Commission will explore a possible extension of the scope of the agriculture marketing standards in the context of the revision of the legislation (as announced in the Farm to Fork Strategy); |
| --- | --- |

—

In line with the Farm to Fork Strategy, the Commission will consider options for animal welfare labelling to improve the transmission of value through the food chain. A requirement to inform consumers whether products come from animals kept in cages or from cage-free systems could encourage farmers to switch earlier to cage-free systems and consumers to become more aware of their choices. Similarly, the Commission will explore a possible extension of the scope of the agriculture marketing standards in the context of the revision of the legislation (as announced in the Farm to Fork Strategy);

| — | Given the role that public procurement can play in transforming the EU’s food production and consumption model by boosting more sustainable sourcing of food, the Commission committed in the Farm to Fork Strategy to determine the best way of setting minimum mandatory criteria for sustainable food procurement. In this context, it will explore how it could support the transition to non-caged systems. Some animal welfare aspects are already addressed in the current green public procurement criteria (43); |
| --- | --- |

—

Given the role that public procurement can play in transforming the EU’s food production and consumption model by boosting more sustainable sourcing of food, the Commission committed in the Farm to Fork Strategy to determine the best way of setting minimum mandatory criteria for sustainable food procurement. In this context, it will explore how it could support the transition to non-caged systems. Some animal welfare aspects are already addressed in the current green public procurement criteria (43);

| — | Where appropriate, Horizon Europe will help provide decision-makers and actors with additional scientific evidence. In particular, the creation of a European Partnership on Animal Health and Welfare will be proposed for the 2023-2024 work programme. |
| --- | --- |

—

Where appropriate, Horizon Europe will help provide decision-makers and actors with additional scientific evidence. In particular, the creation of a European Partnership on Animal Health and Welfare will be proposed for the 2023-2024 work programme.

Further action will include measures to ensure better and stricter implementation of existing legislation, e.g. by training inspectors (through the Commission’s ‘better training for safer food’ (BTSF) programme (44) and with the support of the EU animal welfare reference centres), and by Commission audits of animal welfare systems and their follow-up with national administrations.

In addition, the Member States may target the transition to cage-free farming in their national state aid measures (45). Agricultural state aid rules allow them to grant financial aid to farmers as long as EU standards are not yet in force. In the case of newly introduced EU standards, farmers can receive aid for related investments for a limited period of time.

3.4.   Trade aspects

The Commission seeks to promote the uptake of sustainable standards globally, including on animal welfare, and to promote policy coherence between domestic and imported products. The impact assessment will examine different options on how to achieve this objective with respect to animals and products of animal origin from third countries..

In its Trade policy review (46), the Commission stresses that imports must comply with relevant EU regulation and standards, and that, under certain circumstances determined by World Trade Organization (WTO) rules, it is appropriate for the EU to require that imported products comply with certain production requirements. The legitimacy of applying production requirements to imports is based on the need to protect the environment and to respond to ethical concerns. Where this approach is taken, it must be done in full respect of WTO rules. It is also possible to introduce animal welfare requirements to imported products in the framework of bilateral trade agreements.

Under existing EU legislation, only a few animal species and products are subject to specific animal welfare requirements on import. In the absence of sufficient assurance that the exporting country’s marketing standards for eggs are equivalent to the EU’s, packs of imported eggs must bear an indication that the farming method is ‘non-EC standard’ (47). The health certificate accompanying imported meat must certify that the exporting country’s slaughter requirements are at least equivalent to those laid down in EU animal welfare legislation, e.g. with regard to stunning procedures (48).

The Commission is active in promoting EU animal welfare standards through bilateral cooperation and work with international organisations such as the OIE and the FAO to enhance on-farm conditions for animals worldwide. It has had some success, but this is limited and depends strongly on trade partners’ interest in raising their standards. The Commission intends to maintain and step up its efforts at international level.

As the EU is a major importer of food, the Commission will study this issue in the impact assessment for the revision of the animal welfare legislation, by exploring the following non-mutually exclusive options and their possible combinations (see below). Any future measures the EU takes will need to comply with WTO rules.

Option 1   
  Enhanced cooperation with trading partners

The Commission will set up specific ‘knowledge paths’ to disseminate updated scientific information on alternatives to caged farming systems. It will strive to enhance cooperation with trading partners, particularly those with which the EU has a free trade agreement or with whom trade negotiations are underway or planned. This will be in line with the spirit of the ‘green alliances/partnerships’ referred to in the Farm to Fork Strategy and should boost global uptake of EU standards on animal welfare. The bilateral cooperation will be combined with similar approaches with international organisations and regional bodies.

Option 2   
  Imposing some EU rules on imports

The Commission will assess the scope for translating the EU rules on cages into specific requirements to be applied to imports, following an appropriate transition period, but ensuring that concerns of citizens are addressed. During the transition period, the EU could provide partner countries from which it imports the animals/products in question with support or incentives, for example through:

| — | Technical assistance and cooperation opportunities offered under existing and future trade agreements, and |
| --- | --- |

—

Technical assistance and cooperation opportunities offered under existing and future trade agreements, and

| — | Neighbourhood and pre-accession programmes to upgrade farming systems so as to meet EU requirements and support the transition to cage-free systems. |
| --- | --- |

—

Neighbourhood and pre-accession programmes to upgrade farming systems so as to meet EU requirements and support the transition to cage-free systems.

This would be accompanied by training for inspectors in non-EU countries (through the BTSF programme) and the organisation of awareness-raising activities.

Option 3   
  An animal welfare labelling system that also applies to imports

The Commission will assess the feasibility of introducing labelling requirements to inform EU consumers whether or not products are obtained from animals raised in cages. Such requirements would apply to all products placed on the EU market, including imports, in full compliance with the EU’s international obligations.

For option 2 and 3, accession countries could include project proposals under agriculture and animal welfare headings, including projects to phase out cages, e.g. using the Instrument for Pre-accession Assistance (IPA) (49). The Neighbourhood, Development and International Cooperation Instrument (NDICI) — ‘Global Europe’ (50) is a financial instrument available to other non-EU countries, including those neighbouring the EU.

4.   CONCLUSION AND OUTLOOK

In reply to the European citizens’ initiative ‘End the Cage Age’, the Commission concludes as follows:

The ‘End the Cage Age’ initiative reflects societal concerns, supported by scientific evidence, about the need to ban cages for specific farmed animal species. The initiative aligns with the Commission’s deliberations for actions in this area. The Commission will incorporate the objectives of the initiative in the implementation of the European Green Deal and the Farm to Fork Strategy.

More specifically, the Commission intends to put forward a legislative proposal by the end of 2023 to phase out and finally prohibit the use of cages for all the animal species and categories referred to in the initiative (laying hens, sows, calves, rabbits, pullets, broiler breeders, layer breeders, quail, ducks and geese) as part of the planned revision of EU animal welfare legislation, under conditions (including the length of the transition period) to be determined based on EFSA opinions, the results of an impact assessment and a public consultation.

To this end, the Commission will consider the available science, an assessment of social, economic and environmental impacts, evolving needs and consumer demand. These elements will be taken into account when it comes to determining the length of a reasonable transition period and the accompanying and supporting measures to facilitate the transition. The Commission in particular will assess the feasibility of working towards the proposed legislation entering into force from 2027.

Since the EU is a major importer of food products, it bears a societal responsibility also with regard to the products it imports. The EU will therefore maintain and step up its bilateral and multilateral efforts to raise animal welfare levels in third countries. In the impact assessment, the Commission will consider options to address the issue, such as introducing rules or standards for imported products that are equivalent to the EU’s and/or a labelling requirement, in compliance with WTO rules. This is to take into account EU citizens’ demands and the need for a harmonised solution at EU level to safeguard the Single Market.

The Commission will adopt and pursue or implement specific supporting measures in key related policy areas, such as the CAP, trade, and research and innovation, to facilitate a sustainable and economically viable transition.

---

(1)  Regulation (EU) 2019/788 of the European Parliament and of the Council of 17 April 2019 on the European citizens’ initiative (OJ L 130, 17.5.2019, p. 55).

(2)  The annex provides further procedural details about the initiative, including the required thresholds, and the number of statements of support.

(3)  https://europa.eu/citizens-initiative/initiatives/details/2018/000004_en

(4)  https://www.europarl.europa.eu/doceo/document/B-9-2021-0296_EN.html

(5)  https://ec.europa.eu/info/publications/communication-european-green-deal_en

(6)  https://ec.europa.eu/food/farm2fork_en

(7)  Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes (OJ L 221, 8.8.1998, p. 23).

(8)  Council Directive 1999/74/EC of 19 July 1999 laying down minimum standards for the protection of laying hens (OJ L 203, 3.8.1999, p. 53).

(9)  Council Directive 2008/120/EC of 18 December 2008 laying down minimum standards for the protection of pigs (OJ L 47, 18.2.2009, p. 5).

(10)  Council Directive 2008/119/EC of 18 December 2008 laying down minimum standards for the protection of calves (OJ L 10, 15.1.2009, p. 7).

(11)  https://ec.europa.eu/info/strategy/priorities-2019-2024/european-green-deal_en

(12)  https://ec.europa.eu/food/farm2fork_en

(13)  Eco-schemes are payment schemes in agriculture aimed at protecting the environment and climate, and animal welfare: https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Glossary:Eco-schemes

(14)  The list of potential agricultural practices that eco-schemes could support is available at https://ec.europa.eu/info/sites/info/files/food-farming-fisheries/key_policies/documents/factsheet-agri-practices-under-ecoscheme_en.pdf

(15)  https://ec.europa.eu/eip/agriculture/en/about

(16)  The legislative procedure on the CAP reform is still ongoing. The description of its main elements regarding welfare is therefore subject to final agreement by the co-legislators.

(17)  So called ‘cross-compliance’ under the CAP since 2003. This is not checked systematically prior to payment, but a posteriori cross-compliance on-the-spot checks are obligatory for a minimum of 1 % of beneficiaries. It is an effective tool for raising beneficiaries’ awareness of animal welfare requirements:https://ec.europa.eu/info/food-farming-fisheries/key-policies/common-agricultural-policy/income-support/cross-compliance_en

(18)  The recommendations are tailor-made and addressed to individual Member States. They aim to help each Member State in the drafting of its CAP national strategic plan, by identifying the key areas on which it should focus: https://ec.europa.eu/info/food-farming-fisheries/key-policies/common-agricultural-policy/cap-strategic-plans_en#cap-strategic-plans-recommendations

(19)  Evaluation study of the CAP measures and instruments promoting animal welfare and reduction of antimicrobials use (AGRI-2020-0319; due in October 2021).

(20)  EFSA Panel on Animal Health and Welfare (AHAW), Health and welfare of rabbits farmed in different production systems, scientific opinion (EFSA-Q-2019-00593); adopted 21 November 2019:https://www.efsa.europa.eu/en/efsajournal/pub/5944

(21)  End the cage age: looking for alternatives — overview of alternatives to cage housing and the impact on animal welfare and other aspects of sustainability (30-11-2020):https://www.europarl.europa.eu/thinktank/en/document.html?reference=IPOL_STU%282020 %29658539 https://www.europarl.europa.eu/RegData/etudes/STUD/2020/658539/IPOL_STU(2020)658539_EN.pdf

(22)  Compassion in World Farming (21 February 2021), Scientific briefing on caged farming – overview of scientific research on caged farming of laying hens, sows, rabbits, ducks, geese, calves and quail: https://www.ciwf.eu/media/7444223/ciwf-february-2021-scientific-briefing-on-caged-farming.pdf

(23)  e.g. Assessment of environmental and socio-economic impacts of increased animal welfare standards — transitioning towards cage-free farming in the EU, policy report: https://ieep.eu/publications/assessment-of-environmental-and-socio-economic-impacts-of-increased-animal-welfare-standards;European Economic and Social Committee, The farming profession and the profitability challenge, opinion (adopted 18 July 2019).

(24)  ‘Low-input’ farming, when referring to animals, includes ‘extensive’ farming, access to outdoors, use of local breeds, etc. potentially leading to better welfare and lower use of antibiotics.

(25)  ‘Precision’ farming, when referring to animals, means any technology that makes it possible to follow the livestock, e.g. putting a camera in a barn may help to detect a specific problem at an early stage.

(26)  Network of European ministries and research councils funding research in organic food and farming systems funded in 2004.

(27)  https://projects.au.dk/coreorganiccofund/core-organic-cofund-projects/

(28)  https://www.grouphousenet.eu/about-2

(29)  https://ec.europa.eu/info/research-and-innovation/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe/cluster-6-food-bioeconomy-natural-resources-agriculture-and-environment_en

(30)  Attitudes of Europeans towards animal welfare, Special Eurobarometer 442 (March 2016): file:///C:/Users/sandekn/AppData/Local/Packages/Microsoft.MicrosoftEdge_8wekyb3d8bbwe/TempState/Downloads/ebs_442_en%20(1).pdf

(31)  https://europa.eu/eurobarometer/surveys/detail/2096

(32)  Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes, (OJ L 221, 8.8.1998, p. 23).

(33)  https://www.efsa.europa.eu/en/topics/topic/animal-welfare

(34)  https://ec.europa.eu/food/animals/welfare/strategy/evaluation_strategy_en

(35)  The fitness check will cover Directive 98/58/EC, Directive 1999/74/EC, Regulation (EC) No 1/2005, Directive 2007/43/EC, Directive 2008/119/EC, Directive 2008/120/EC and Regulation (EC) No 1099/2009, and the relevant implementing rules.

(36)  The results of the study are expected for the end of 2021.

(37)  e.g. Pilot project hens (SANTE-2020-G5 051) on laying hens, pullets and layer breeders (due in 2022): Evaluation study of the CAP measures and instruments promoting animal welfare and reduction of antimicrobials use (AGRI-2020-0319; due in October 2021).

(38)  Terrestrial Animal Health Code, Section 7: https://www.oie.int/en/standard-setting/terrestrial-code/access-online/ Aquatic Animal Health Code, Section 7 https://www.oie.int/en/standard-setting/aquatic-code/access-online/

(39)  ‘Aid intensity’ refers to the proportion of public (EU or national) support in the overall investment. An increase in aid intensity reduces the proportion to be paid by the farmer.

(40)  Under Regulation (EU) No 1144/2014, the promotion policy involves co-funding opportunities run by EU or inter-trade associations for promotion activities.

(41)  https://ec.europa.eu/info/sites/info/files/food-farming-fisheries/farming/documents/com2021_141-organic-action-plan_en.pdf

(42)  https://ec.europa.eu/info/food-farming-fisheries/key-policies/common-agricultural-policy/income-support/cross-compliance/fas_en

(43)  https://ec.europa.eu/jrc/en/publication/eu-gpp-criteria-food-procurement-catering-services-and-vending-machines

(44)  https://ec.europa.eu/food/safety/btsf_en

(45)  State aid is decided and 100 % financed by the Member States: https://ec.europa.eu/competition/sectors/agriculture/overview_en.html

(46)  Trade policy review — an open, sustainable and assertive trade policy, Communication to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions (adopted 18 February 2021): https://trade.ec.europa.eu/doclib/docs/2021/february/tradoc_159438.pdf

(47)  Article 30 of Commission Regulation (EC) No 589/2008 of 23 June 2008 laying down detailed rules for implementing Council Regulation (EC) No 1234/2007 as regards marketing standards for eggs (OJ L 163, 24.6.2008, p. 6).

(48)  Article 12 of Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (OJ L 303, 18.11.2009, p. 1).

(49)  Overview — Instrument for Pre-accession Assistance

(50)  factsheet-mff-multiannual-financial-framework-v09_en.pdf

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ANNEX

PROCEDURAL ASPECTS OF CITIZENS’ INITIATIVE ON ‘END THE CAGE AGE’

Pursuant to Articles 4(2) and 10 of Regulation (EU) No 211/2011 on the citizens’ initiative, the Commission registered the present initiative on 11 September 2018 and published the relevant information in its online register at: https://europa.eu/citizens-initiative/initiatives/details/2018/000004_en

The members of the citizens’ committee registered with the Commission are residents of the following Member States: Czechia, Germany, Greece, France, Italy, the Netherlands and Poland.

The initiative was registered in English. Its title, subject matter and objectives were published in all official EU languages.

In accordance with the Regulation on the citizens’ initiative, the forms used by citizens to express their support for the initiative contained its title, subject matter and objectives, and a link to the online register, so that people could access more detailed information.

The 12-month collection period started on the date of registration and ended on 11 September 2019. After the relevant national authorities had verified the collected statements of support, the organisers submitted the initiative to the Commission on 2 October 2020, together with certificates issued by the Member States’ competent authorities, in accordance with Article 9 of the Regulation.

The organisers collected valid statements of support exceeding the thresholds in a record number of 18 Member States. The numbers indicated in the certificates are given in the table below:

| Member State | Number of signatories | Threshold to qualify for minimum of seven Member States |
| --- | --- | --- |
| Austria | 20 403 | 13 500 |
| Belgium | 62 397 | 15 750 |
| Bulgaria | 17 986 | 12 750 |
| Croatia | 12 498 | 8 250 |
| Cyprus | 1 610 | 4 500 |
| Czechia | 49 219 | 15 750 |
| Denmark | 47 336 | 9 750 |
| Estonia | 3 560 | 4 500 |
| Finland | 32 716 | 9 750 |
| France | 89 600 | 55 500 |
| Germany | 474 753 | 72 000 |
| Greece | 9 003 | 15 750 |
| Hungary | 2 550 | 15 750 |
| Ireland | 14 646 | 8 250 |
| Italy | 90 085 | 54 750 |
| Latvia | 3 631 | 6 000 |
| Lithuania | 8 449 | 8 250 |
| Luxembourg | 5 510 | 4 500 |
| Malta | 1 694 | 4 500 |
| Netherlands | 153 958 | 19 500 |
| Poland | 54 039 | 38 250 |
| Portugal | 13 948 | 15 750 |
| Romania | 8 308 | 24 000 |
| Slovakia | 29 413 | 9 750 |
| Slovenia | 3 553 | 6 000 |
| Spain | 85 756 | 40 500 |
| Sweden | 46 378 | 15 000 |
| United Kingdom (1) | 54 114 | 54 750 |
| Total | 1 397 113 | |

Member State

Number of signatories

Threshold to qualify for minimum of seven Member States

Austria

20 403

13 500

Belgium

62 397

15 750

Bulgaria

17 986

12 750

Croatia

12 498

8 250

Cyprus

1 610

4 500

Czechia

49 219

15 750

Denmark

47 336

9 750

Estonia

3 560

4 500

Finland

32 716

9 750

France

89 600

55 500

Germany

474 753

72 000

Greece

9 003

15 750

Hungary

2 550

15 750

Ireland

14 646

8 250

Italy

90 085

54 750

Latvia

3 631

6 000

Lithuania

8 449

8 250

Luxembourg

5 510

4 500

Malta

1 694

4 500

Netherlands

153 958

19 500

Poland

54 039

38 250

Portugal

13 948

15 750

Romania

8 308

24 000

Slovakia

29 413

9 750

Slovenia

3 553

6 000

Spain

85 756

40 500

Sweden

46 378

15 000

United Kingdom (1)

54 114

54 750

Total

1 397 113

As the initiative was registered before 1 January 2020, the collection and verification of statements of support and the submission of the valid initiative to the Commission were governed by Regulation (EU) No 211/2011. The Commission’s subsequent examination of the initiative and its reply, as presented in this Communication, are governed by Regulation (EU) 2019/788 on the European citizens’ initiative, which applies from 1 January 2020 (having replaced and repealed Regulation (EU) No 211/2011).

The Commission met the organisers on 30 October 2020. It was represented by Vice-President Jourová, Commissioner Kyriakides and senior officials from the services concerned.

On 15 April 2021, the organisers were given the opportunity to present the initiative in a public hearing at the European Parliament, in accordance with Article 14(2) of Regulation (EU) 2019/788 (2). The Commission was represented by Vice-President Jourová and Commissioners Kyriakides and Wojciechowski.

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(1)  The collection period ended on 11 September 2019. Statements of support submitted on the United Kingdom form could be taken into account as they were verified and certified before the date of withdrawal of the United Kingdom from the European Union.

(2)  With the agreement of the organisers, the public hearing had been postponed due to the COVID-19 pandemic and took place remotely, in line with Regulation (EU) 2020/1042 of the European Parliament and of the Council of 15 July 2020 laying down temporary measures concerning the time limits for the collection, the verification and the examination stages provided for in Regulation (EU) 2019/788 on the European citizens’ initiative in view of the COVID-19 outbreak (OJ L 231, 17.7.2020, p. 7).

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| 9.7.2021 | EN | Official Journal of the European Union | C 274/14 |
| --- | --- | --- | --- |

9.7.2021

EN

Official Journal of the European Union

C 274/14

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Commission Notice on marketing authorisations for veterinary medicinal products for which the expiry of the 5-year period of validity falls on or after the date of entry into application of Regulation (EU) 2019/6

(2021/C 274/02)

1.   Introduction

The purpose of this Notice is to inform stakeholders on how the Commission intends to deal with centrally authorised veterinary medicinal products for which the expiry of the 5-year period of validity of the marketing authorisation falls on or after 28 January 2022. The Notice also addresses certain questions that may arise in relation to nationally authorised products.

This Notice should be read in conjunction with the relevant provisions of Directive 2001/82/EC (1) and Regulation (EU) 2019/6 on veterinary medicinal products (2). It clarifies the provisions already contained in the applicable legislation and does not extend in any way the obligations deriving from such legislation nor introduce any additional requirements on the concerned operators and competent authorities.

This Notice is merely intended to assist business operators and national competent authorities in the application of the relevant legislation. Only the Court of Justice of the European Union is competent to authoritatively interpret Union law. The views expressed in this Notice cannot prejudge the position that the European Commission might take before the Union and national Courts.

2.   Status of marketing authorisations for which the expiry of the 5-year period of validity falls on or after the date of entry into application of Regulation (EU) 2019/6

Regulation (EU) 2019/6 on veterinary medicinal products (‘the VMP Regulation’), which repeals Directive 2001/82/EC, will enter into application on 28 January 2022.

Article 5(2) of the VMP Regulation provides that a marketing authorisation’s validity is unlimited from the moment the authorisation is granted. Article 152(1) provides that marketing authorisations granted in accordance with both Directive 2001/82/EC and Regulation (EC) No 726/2004 (3) shall be deemed to have been issued in accordance with the VMP Regulation. However, Article 28(1) and (2) of Directive 2001/82/EC provides that marketing authorisations are initially valid for five years and become unlimited only after a renewal procedure. For centrally authorised products, Article 39 of Regulation (EC) No 726/2004 mirrors this provision.

Therefore, as of 28 January 2022, a new single-step system for acquiring a marketing authorisation for an unlimited duration will replace the previous two-step process of both Directive 2001/82/EC and Regulation (EC) No 726/2004.

The VMP Regulation does not foresee a situation that would require a renewal, as marketing authorisations granted under the Regulation are in principle valid for an unlimited period. Equally, it does not contain any provisions addressing the renewal of existing marketing authorisations granted under Directive 2001/82/EC or Regulation (EC) No 726/2004.

Furthermore, there is no legal basis in any of the relevant EU legislation to specifically anticipate that the marketing authorisations in question would automatically become valid for an unlimited period as of 28 January 2022. Consequently, regulatory action is required in order to give effect to Article 152(1) of the VMP Regulation, as explained below.

Marketing authorisations granted under Regulation (EC) No 726/2004 are in the form of a Commission Implementing Decision, which provides in its enacting terms that the period of validity of the marketing authorisation is five years from the date of notification of the Decision to the marketing authorisation holder. These individual decisions granting marketing authorisations will need to be amended to remove the provision with the expiry date. This applies in principle to both centrally authorised and nationally authorised products. For centrally authorised products, under EU law, it is only possible to do this by amending each decision individually.

For nationally authorised products, Member States will need to take the necessary measures to ensure that the national decisions concerned are amended in due course in order to remove the 5-year time limit. The manner in which this is achieved will depend on national law.

3.   Applications for renewal submitted before entry into application of Regulation (EU) 2019/6

Article 151 (1) and (2) of the VMP Regulation states that procedures concerning the applications for marketing authorisations for veterinary medicinal products or of variations that have been validated in accordance with either Regulation (EC) No 726/2004 or Directive 2001/82/EC before 28 January 2022 shall be completed in accordance with Regulation (EC) No 726/2004 and the Directive, respectively.

Consequently, applications for renewal of marketing authorisations granted under either Directive 2001/82/EC or Regulation (EC) No 726/2004 that are validated before entry into application of Regulation (EU) 2019/6 will be processed under Directive 2001/82/EC or Regulation (EC) No 726/2004, respectively. The relevant provisions require the submission of an application for a renewal at least six months before the expiry of the marketing authorisation.

Should they wish to (and in consultation with the relevant competent authority), marketing authorisation holders may apply for a renewal under Directive 2001/82/EC or Regulation (EC) No 726/2004 further in advance than the usual 6 months in cases where, in the absence of a request for renewal, the expiry of the marketing authorisation would fall upon or after entry into application of the VMP Regulation.

4.   Questions and Answers

For both centrally and nationally authorised products

Question 1:

What do I need to do if the period of validity of the marketing authorisation for my veterinary medicinal product is due to expire upon or after the entry into application of the VMP Regulation?

Answer:

For centrally authorised veterinary medicinal products, the European Medicines Agency (‘the Agency’) will send a letter concerning the expiry of the validity of the marketing authorisation. You will need to reply to this letter to confirm whether or not you wish your marketing authorisation to be unlimited in duration upon expiry of its 5-year period of authorisation. If you reply in the affirmative, the Commission will then take the necessary steps to ensure that the marketing authorisation becomes unlimited in duration. If you reply in the negative or do not reply to the letter from the Agency, the marketing authorisation will automatically expire after the 5-year period of validity.

Alternatively, you could apply for a renewal, under existing legislation, before entry into application of the VMP Regulation (4) (see question 2 below).

For nationally authorised products, you should contact the national competent authority to ascertain what steps you must take.

Question 2:

In cases where the expiry of my marketing authorisation after the 5-year period would fall on or after entry into application of the VMP Regulation, can I choose to apply earlier than 6 months before expiry of the marketing authorisation for the renewal of the marketing authorisation for my veterinary medicinal product?

Answer:

Yes, in consultation with the relevant competent authority, it is possible to apply early for a renewal in these circumstances in accordance with Directive 2001/82/EC or Regulation (EC) No 726/2004, as applicable. Please note that the validation date of the renewal application should fall before 28 January 2022 and that in this case an assessment will be undertaken.

Question 3:

Would there be any assessment by the Commission or the national competent authority before the marketing authorisation decision is administratively amended to remove the 5-year time limit for the period of validity?

Answer:

No, there will be no assessment involved in an administrative removal of the 5-year limit for the period of validity, i.e. where no renewal application has been submitted.

Question 4:

What happens if, by 28 January 2022, a decision has not yet been taken on my ongoing application for renewal of a marketing authorisation submitted under Directive 2001/82/EC or Regulation (EC) No 726/2004, as applicable?

Answer:

In accordance with Article 151 of the VMP Regulation, the renewal request will be dealt with under Directive 2001/82/EC or Regulation (EC) No 726/2004, as applicable, and the marketing authorisation will remain valid until the end of its validity as stated in the decision granting the marketing authorisation.

Question 5:

What if the marketing authorisation for my veterinary medicinal product already has an unlimited duration?

Answer:

The status of your marketing authorisation will remain the same and no further action is required.

For centrally authorised products only

Question 6:

What if there is a gap in time between expiry of the 5-year time limit for the period of validity and the new decision making it unlimited?

Answer:

If you express your interest in obtaining an unlimited duration of the marketing authorisation for your veterinary medicinal product, the marketing authorisation will remain valid in practice until amendment of the marketing authorisation decision, which will ‘regularise’ the legal situation regarding unlimited duration of that marketing authorisation.

Question 7:

What if there are no upcoming procedures that would necessitate amendment of the decision for the veterinary medicinal product concerned before the expiry date of the marketing authorisation and following the entry into application of Regulation (EU) 2019/6?

Answer:

If there are no timely upcoming procedures, the Commission will issue a Decision amending the marketing authorisation at or around the marketing authorisation’s expiry date. If such a Decision is not adopted before the expiry date of the marketing authorisation, the marketing authorisation will remain valid in practice until amendment of the marketing authorisation decision, which will ‘regularise’ the legal situation regarding unlimited duration of that marketing authorisation.

Question 8:

What will happen to my marketing authorisation if I do not submit a renewal application and I do not reply to the letter asking if I wish my marketing authorisation to become indefinite?

Answer:

The marketing authorisation would expire naturally at the current date of expiry of the period of validity.

---

(1)  Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (OJ L 311, 28.11.2001, p. 1).

(2)  Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).

(3)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).

(4)  The validation date of the renewal application should be before 28 January 2022.

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| 9.7.2021 | EN | Official Journal of the European Union | C 274/17 |
| --- | --- | --- | --- |

9.7.2021

EN

Official Journal of the European Union

C 274/17

---

Initiation of proceedings

(Case M.10078 — Cargotec/Konecranes)

(Text with EEA relevance)

(2021/C 274/03)

On 2 July 2021, the Commission decided to initiate proceedings in the above-mentioned case after finding that the notified concentration raises serious doubts as to its compatibility with the internal market. The initiation of proceedings opens a second phase investigation with regard to the notified concentration, and is without prejudice to the final decision on the case. The decision is based on Article 6(1)(c) of Council Regulation (EC) No 139/2004 (1).

The Commission invites interested third parties to submit their observations on the proposed concentration to the Commission.

In order to be fully taken into account in the procedure, observations should reach the Commission not later than 15 days following the date of this publication. Observations can be sent to the Commission by fax (+32 22964301), by email to COMP-MERGER-REGISTRY@ec.europa.eu or by post, under reference M.10078 — Cargotec/Konecranes, to the following address:

| European Commission |
| --- |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

(1)  OJ L 24, 29.1.2004, p. 1 (the ’Merger Regulation’).

---

IV Notices

NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES

European Commission

| 9.7.2021 | EN | Official Journal of the European Union | C 274/18 |
| --- | --- | --- | --- |

9.7.2021

EN

Official Journal of the European Union

C 274/18

---

Euro exchange rates (1)

8 July 2021

(2021/C 274/04)

1 euro =

| | Currency | Exchange rate |
| --- | --- | --- |
| USD | US dollar | 1,1838 |
| JPY | Japanese yen | 129,91 |
| DKK | Danish krone | 7,4366 |
| GBP | Pound sterling | 0,86133 |
| SEK | Swedish krona | 10,1908 |
| CHF | Swiss franc | 1,0851 |
| ISK | Iceland króna | 146,30 |
| NOK | Norwegian krone | 10,4138 |
| BGN | Bulgarian lev | 1,9558 |
| CZK | Czech koruna | 25,894 |
| HUF | Hungarian forint | 358,57 |
| PLN | Polish zloty | 4,5504 |
| RON | Romanian leu | 4,9272 |
| TRY | Turkish lira | 10,2904 |
| AUD | Australian dollar | 1,5957 |
| CAD | Canadian dollar | 1,4893 |
| HKD | Hong Kong dollar | 9,1967 |
| NZD | New Zealand dollar | 1,7048 |
| SGD | Singapore dollar | 1,6020 |
| KRW | South Korean won | 1 361,34 |
| ZAR | South African rand | 17,0554 |
| CNY | Chinese yuan renminbi | 7,6832 |
| HRK | Croatian kuna | 7,4913 |
| IDR | Indonesian rupiah | 17 280,56 |
| MYR | Malaysian ringgit | 4,9501 |
| PHP | Philippine peso | 59,347 |
| RUB | Russian rouble | 89,0266 |
| THB | Thai baht | 38,497 |
| BRL | Brazilian real | 6,2463 |
| MXN | Mexican peso | 23,7922 |
| INR | Indian rupee | 88,6073 |

Currency

Exchange rate

USD

US dollar

1,1838

JPY

Japanese yen

129,91

DKK

Danish krone

7,4366

GBP

Pound sterling

0,86133

SEK

Swedish krona

10,1908

CHF

Swiss franc

1,0851

ISK

Iceland króna

146,30

NOK

Norwegian krone

10,4138

BGN

Bulgarian lev

1,9558

CZK

Czech koruna

25,894

HUF

Hungarian forint

358,57

PLN

Polish zloty

4,5504

RON

Romanian leu

4,9272

TRY

Turkish lira

10,2904

AUD

Australian dollar

1,5957

CAD

Canadian dollar

1,4893

HKD

Hong Kong dollar

9,1967

NZD

New Zealand dollar

1,7048

SGD

Singapore dollar

1,6020

KRW

South Korean won

1 361,34

ZAR

South African rand

17,0554

CNY

Chinese yuan renminbi

7,6832

HRK

Croatian kuna

7,4913

IDR

Indonesian rupiah

17 280,56

MYR

Malaysian ringgit

4,9501

PHP

Philippine peso

59,347

RUB

Russian rouble

89,0266

THB

Thai baht

38,497

BRL

Brazilian real

6,2463

MXN

Mexican peso

23,7922

INR

Indian rupee

88,6073

---

(1)  Source: reference exchange rate published by the ECB.

---

V Announcements

PROCEDURES RELATING TO THE IMPLEMENTATION OF COMPETITION POLICY

European Commission

| 9.7.2021 | EN | Official Journal of the European Union | C 274/19 |
| --- | --- | --- | --- |

9.7.2021

EN

Official Journal of the European Union

C 274/19

---

Prior notification of a concentration

(Case M.10345 — Equistone Partners Europe/CVG)

Candidate case for simplified procedure

(Text with EEA relevance)

(2021/C 274/05)

1.

This notification concerns the following undertakings:

| — | Equistone Partners Europe SAS (‘Equistone Partners Europe’, France); and |
| --- | --- |

—

Equistone Partners Europe SAS (‘Equistone Partners Europe’, France); and

| — | CVG SAS (‘CVG’, France) and all its subsidiaries. |
| --- | --- |

—

CVG SAS (‘CVG’, France) and all its subsidiaries.

Equistone Partners Europe acquires within the meaning of Article 3(1)(b) of the Merger Regulation sole control of the whole of CVG and of its subsidiaries.

The concentration is accomplished by way of purchase of shares.

2.

| — | Equistone Partners Europe: management of professional private equity funds; |
| --- | --- |

—

Equistone Partners Europe: management of professional private equity funds;

| — | CVG: sale of children’s products (clothes, shoes, home products, childcare products and toys) under the Vertbaudet brand. |
| --- | --- |

—

CVG: sale of children’s products (clothes, shoes, home products, childcare products and toys) under the Vertbaudet brand.

3.

Pursuant to the Commission Notice on a simplified procedure for treatment of certain concentrations under Council Regulation (EC) No 139/2004 (2), it should be noted that this case is a candidate for treatment under the procedure set out in the Notice.

4.

Observations must reach the Commission no later than ten days following the date on which this notification is published. The following reference should always be specified:

M.10345 — Equistone Partners Europe/CVG

Observations can be sent to the Commission by e-mail, by fax, or by post. Please use the contact details below:

Email: COMP-MERGER-REGISTRY@ec.europa.eu

Fax +32 22964301

Postal address:

| European Commission |
| --- |
| Directorate-General for Competition |
| Merger Registry |
| 1049 Bruxelles/Brussel |
| BELGIQUE/BELGIË |

European Commission

Directorate-General for Competition

Merger Registry

1049 Bruxelles/Brussel

BELGIQUE/BELGIË

---

(1)  OJ L 24, 29.1.2004, p. 1 (the ‘Merger Regulation’).

1

(2)  OJ C 366, 14.12.2013, p. 5.

2

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