COMMUNICATION FROM THE COMMISSION

on the European Citizens’ Initiative (ECI) ‘Save cruelty-free cosmetics – Commit to a Europe without animal testing’

(2023/C 290/01)

1.   INTRODUCTION: THE EUROPEAN CITIZENS’ INITIATIVE

EU citizens can ask the European Commission to submit a proposal for legislation on a matter they consider requires legal action to uphold the EU treaties. To do so, they must submit a European citizens’ initiative (ECI) under Article 11(4) of the Treaty on European Union, which requires collecting the signatures of at least one million nationals of a significant number of Member States. Regulation (EU) 2019/788 (1) (the ‘ECI Regulation’), which applies as of 1 January 2020, sets out detailed rules on the ECI.

‘Save cruelty-free cosmetics – Commit to a Europe without animal testing’ is the ninth ECI (2) to reach the thresholds required by the Treaty on European Union and the ECI Regulation. It is also the fifth successful initiative on animal welfare or the environment. The initiative calls on the Commission to take action on the use of animals for scientific purposes, as set out below.

1) Protect and strengthen the cosmetics animal testing ban. Initiate legislative change to achieve consumer, worker, and environmental protection for all cosmetics ingredients without testing on animals for any purpose at any time. 2) Transform EU chemicals regulation. Ensure human health and the environment are protected by managing chemicals without the addition of new animal testing requirements. 3) Modernise science in the EU. Commit to a legislative proposal plotting a roadmap to phase out all animal testing in the EU before the end of the current legislative term.

Following the organisers’ request on 21 May 2021, the Commission registered the initiative (3) on 30 June 2021. On 25 January 2023, after verification of the statements of support by the Member State authorities, the organisers submitted the initiative to the Commission (4). The Commission has examined the initiative on the basis of the ECI Regulation.

The organisers detailed the objectives of the initiative in a meeting with the Commission on 17 March 2023 (5) and at the public hearing organised by the European Parliament on 25 May 2023 (6). Furthermore, on 10 July 2023, the Parliament held a plenary debate on the ECI.

This Communication sets out the Commission’s legal and political conclusions on the initiative and any action it intends to take in response to the initiative in accordance with Article 15(2) of the ECI Regulation.

2.   CONTEXT

Article 13 of the Treaty on the Functioning of the European Union recognises the need to protect animals as sentient beings. It requires the EU and its Member States to pay full regard to the welfare requirements of animals in formulating and implementing the EU's agriculture, fisheries, transport, single market, research and technological development and space policies.

The EU’s legislative and policy framework has been globally recognised as leading in the areas of phasing out the use of animals and promoting animal welfare. Major achievements of this policy include the introduction of the full ban on animal testing for cosmetics in the EU in 2013 (7) and the more than EUR 1 billion in funding provided to research and innovation initiatives using non-animal methods across the EU f in the last two decades.

The use of animals in science constitutes a major cross-cutting issue. Notwithstanding progress made, a large number of animals are still used for testing in Europe. Animals are used for several purposes in research and safety assessment of chemicals and medicines where no alternatives are available to provide a high level of protection of human health and the environment (including animal health).

In 2020, 7,9 million animals in total were used for testing for research, training and education, or for regulatory purposes in the EU (excluding the UK) and Norway (8). This number is 7,5 % lower than in 2019 (8,5 million) and 11,4 % lower than in 2018 (8,8 million) (9). The most-used species were mice (49 %) and fish (27 %). As in previous years, the main purpose of animal use was research (72 %), 41 % of all use being for basic research and 31 % for translational and applied research. Of all animal use 17 % was to satisfy regulatory requirements as itemised below, followed by animals used for routine production (5 %), including the production of antibodies or blood-based products. Of all animal use to satisfy regulatory requirements (1,4 million occurences in total), 54 % was for human medicinal products, 22,8 % for veterinary medicinal products, 8,7 % for industrial chemicals (this is related to chemicals legislation such as the REACH Regulation (10)), 2.8 % for feed and food products, 4.8 % for plant protection products, 3.6 % for medical devices, 0.3 % for biocides and 3.0 % for other purposes.

2.1.   Legislative acts relevant to animal testing

The body of EU law affecting animal testing is rather broad and, in principle, could be split in three categories. In the first one, there is the Directive 2010/63/EU on the protection of animals used for scientific purposes (11) that sets general goals and rules on the welfare of animals used in testing when animal use cannot be avoided. The second one consists of cross-cutting acts targeting chemicals such as the REACH Regulation, which contains cross-sectoral rules. The third one represents multiple sectoral legal acts setting out rules for the assessment of chemicals used in specific sectors or products. Both the REACH Regulation and sector-specific EU legal acts contain data requirements or provisions leading to animal testing to assess potential impacts of products and substances on human or animal health or on the environment.

2.1.1.   Legislation to protect animals used for scientific purposes

The Directive on the protection of animals used for scientific purposes sets the ultimate goal of fully phasing out all animal use for research and for regulatory purposes in the EU. Another cornerstone of the Directive is the need to comply with the principle of the Three Rs:

—	replacement of studies relying on animals by using methods not involving live animals

—	reduction: adaptation of test methods or assessment approaches in a way that reduces the number of animals needed for a scientifically sound outcome

—

refinement of methods that help minimise pain, suffering and distress experienced by the animals used or increase their welfare. — The Directive also lays down the specific duties of the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) (12) , which is an integral part of the Commission’s Joint Research Centre (JRC). It carries out a range of activities to promote the use of non-animal methods in legislation, biomedical science and education. The Directive entrusts the EURL ECVAM with the development of alternative approaches, participating in and coordinating validation and setting up databases and information systems, among other things. The Directive requires Member States to regularly provide statistical data (13) on the use of animals for scientific purposes. It also requires the Commission to set up dedicated, publicly available databases (14).

2.1.2.   Cross-cutting EU law on chemicals

The REACH Regulation is a cross-cutting legal act on chemicals, which requires the provision of information on chemicals to ensure their safe manufacture, import and use. The Annexes to the REACH Regulation specify methods for generating hazard information, several of which are still animal test methods. However, registrants are only allowed to use animal testing as a last resort. Vertebrate animal tests should be replaced whenever possible by alternative methods. Annex XI to the REACH Regulation lists alternative methods to adapt the standard testing regime and the European Chemicals Agency (ECHA) provides comprehensive guidance (15).

Furthermore, the REACH Regulation contains specific rules on data sharing to avoid unnecessary tests. Finally, the REACH Regulation provides for prior validation of testing proposals, which ensures that animal testing is only used as a last resort and only when required.

The use of available alternative methods under the REACH Regulation is ensured by their listing in the Test Methods Regulation (16) , among other things. The recent revision of this Regulation will lead to an accelerated uptake of test methods once they are adopted by the Organisation for Economic Cooperation and Development (OECD) since it now refers directly to the OECD methods instead of describing them in the regulation.

Note also that a planned targeted revision of the REACH Regulation could be an opportunity to include the generation of more hazard information e.g. on endocrine disruption for all substances and more information on substances registered in the lowest tonnage range. The exact delivery mechanism under the revised REACH Regulation is still under discussion.

2.1.3.   Sectoral legislation

Cosmetics Regulation

The Cosmetics Regulation13 is the most advanced EU legal act as regards phasing out animal testing since it bans the placing on the market of cosmetic products that have been tested on animals to meet the requirements of the Regulation. The animal testing ban under the Cosmetics Regulation is discussed in detail in section 3.1.

Plant Protection Products Regulation and Biocidal Products Regulation

The Plant Protection Products Regulation (17) and the Biocidal Products Regulation (18) (the ‘BPR’) provide that unnecessary animal testing must be avoided. Both Regulations set out the requirements for the submission of data in applications for the approval of substances under these regulations. The design of studies must take full account of the Three Rs principle, in particular when appropriate validated methods become available. Applicants must share data to avoid vertebrate studies and duplication. In particular, a mandatory data-sharing mechanism has been set up for studies on biocidal active substances and biocidal products involving vertebrates: a prior request to ECHA to check if such studies have already been submitted under the BPR is needed before initiating studies. The information requirements laid down in Annexes II and III to the BPR were amended in 2021 (19) to address new testing strategies favouring in vitro methods over in vivo testing.

Medicinal products for human use

The general legal framework on human medicines consists of Directive 2001/83/EC (20) and Regulation (EC) No 726/2004 (21). It fully takes into account the Three Rs principle as introduced by Directive 2010/63/EU. The regulatory authorities in the EU will accept all validated methodologies supporting this principle. Alternative testing approaches that have not been assessed in a formal validation process can also be accepted by the responsible authorities (i.e. European Medicines Agency and national competent authorities) on a case-by-case basis and following an evaluation of the data submitted by the applicant.

Furthermore, abridged marketing authorisation applications (e.g. for generics and biosimilars) and informed consent applications can rely on the preclinical and clinical studies conducted for the purpose of obtaining a marketing authorisation of a reference medicinal product. In such cases, the applicant refers to the data that was submitted by the originator (there is no duplication of tests).

The above mentioned EU general pharmaceutical legislation for human medicinal products has been reviewed recently and the Commission adopted a new legal proposal (22) on 26 April 2023. Some proposed changes aim to strengthen the Three Rs principle across the lifecycle of a medicinal product. In addition, the legislative proposal strengthens the current rules by adding obligations for marketing authorisation applicants or holders and by facilitating alternative testing approaches. The new rules will also encourage more cooperation between EU agencies and the national competent authorities in assessing substances, facilitating data sharing and carrying out joint non-clinical studies to avoid unnecessary duplication of tests with live animals. The proposal also aims to future-proof the legislation in order to allow the use of alternative testing methods.

Veterinary medicinal products

The EU legal framework on veterinary medicines was revised by Regulation (EU) 2019/6 (23). It requires applicants for authorisation of any veterinary medicinal product to use the minimum number of animals in the control tests carried out during the manufacturing process of both immunological and non-immunological veterinary medicinal products, and on finished immunological veterinary medicinal products. Alternative in vitro test must be used when this leads to replacement or reduction of animal use or reduction of suffering. As for human medicines, some marketing authorisation applications (e.g. for generics) can rely on the studies in animals conducted for the reference veterinary medicinal product. Regulation (EU) 2019/6 also provides the possibility of granting other prospective applicants access to data via a letter of access (e.g. for applications based on informed consent) to avoid unnecessary animal testing.

Clinical trials for veterinary medicinal products are exempted from the scope of Directive 2010/63/EU on the protection of animals used for scientific purposes since the legislation on veterinary medicinal products already provides appropriate animal-welfare measures: clinical trials should take into account the Three Rs principle, use alternative test methods wherever possible and take into account the guidelines of the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (24).

Medical devices

The legal framework on medical devices was revised in 2017 with the adoption of the Regulation on medical devices (25) and the Regulation on in-vitro diagnostic medical devices (26). In few cases tests on animals may take place, for pre-clinical studies. These tests must be conducted in accordance with Directive 2010/63/EU.

2.2.   Current EU policy context

On 14 October 2020, the Commission adopted its Communication on Chemicals Strategy for Sustainability – Towards a Toxic-Free Environment under the European Green Deal (27). This Strategy has a dual goal: improving protection of people’s health and the environment and boosting innovation for safe and sustainable chemicals. The Strategy announces the revision of the EU’s framework of chemical legislation and reiterates the EU’s ultimate goal of full replacement of animal testing, committing to fostering multidisciplinary research and digital innovations for advanced tools, methods and models, and data analysis capacities.

The strategy lists 85 action points, of which several support reducing or phasing out animal testing. For instance, the proposal for a regulation on chemicals data (28) under the ‘one substance, one assessment’ umbrella would bring available information on chemicals together on one platform. This could help authorities group chemicals for risk management or support read-across, reducing the need for animal data. Another example is the Commission Recommendation establishing a European assessment framework for ‘safe and sustainable by design’ chemicals and materials (29), which promotes the use of new approach methodologies (NAMs) for chemical safety assessment, integrating them into the design and development of chemicals as early as possible.

In September 2021, the Parliament adopted a resolution (30) requesting to accelerate the transition to innovation without the use of animals in research, regulatory testing and education. The Commission responded to the resolution measures by outlining the actions it takes to reduce animal testing30.

2.3.   EU research on alternative approaches, education and training

During the last two decades, the Commission has invested more than EUR 1 billion into over 300 research projects related to alternative methods to animal testing. Many of these projects have generated new tools and methods that are used for regulatory purposes, to predict the safety of chemicals, to understand diseases, or to assess the effectiveness of new treatments.

The EU Framework Programmes for Research and Innovation, Horizon 2020 and Horizon Europe, fund ambitious research projects on alternatives to animal testing. Two prominent examples are the ASPIS cluster on animal-free safety assessment of chemicals with a budget of EUR 60 million from Horizon 2020 (31) and the PARC partnership with a total budget of EUR 400 million, of which EUR 200 million is provided by Horizon Europe (32) , (33). ASPIS provides NAMs to improve the accuracy, speed and affordability of chemical safety testing without using laboratory animals. It is currently developing a framework, called the ASPIS Safety Profiling Algorithm (ASPA), based on a tiered approach for Next Generation Risk Assessment (NGRA) in the safety assessment of chronic adverse health effects associated with chemical exposure. PARC aims to support the move towards NGRA and the increased acceptance and use of NAMs. Against this background, a good collaboration between ASPIS and PARC is set up in this context. PARC is also supporting the development of a toolbox for implementing the ‘safe and sustainable by design’ framework promoting the use of in silico tools in risk assessment.

The 2023-2024 work programme of Horizon Europe Cluster 1 ‘Health’ will complem these important initiatives by funding research project on alternatives to animal testing in biomedical sciences in areas with limited translational value of animal-based approaches, the highest use of animals, or the most severe animal suffering (EUR 25 million; submission deadline 19 September 2023). To foster uptake of alternatives to animal testing, the 2023-2024 Work Programme of Horizon Europe cluster 1 contains a topic aiming to support the training of regulators and improve regulatory uptake (topic submission deadline 11 April 2024) (34).

The Innovative Medicines Initiative Joint Undertaking, the predecessor of the Innovative Health Initiative Joint Undertaking, also invested in alternatives to animal methods. These projects have generated, among other things, an in silico test to predict the toxicity of chemicals, and accelerate drug development without using animals. The Innovative Health Initiative Joint Undertaking (35) will continue investing in the development of alternatives to animal testing and fostering uptake by the health industry. A relevant topic is planned to be launched before the end of 2023.

Awareness, education and training are essential to foster the use of non-animal methods, as highlighted also by the ECI. While education and training formally are a Member State responsibility, the EURL ECVAM is engaged in several education and training activities aiming at increasing the awareness of Three Rs principle at the levels of secondary school, university and early professional training. The core business of this activity is the deployment of a proper strategy to produce a comprehensive set of teaching resources, and a set of guidance documents to inform educators and educational institutions about effective ways of creating, adapting and implementing curricula and practices specific to the teaching of Three Rs principle. Furthermore, the biannual edition of the JRC Summer School on non-animal approaches in science provides students with the opportunity to learn from experts in the fields of cutting-edge technologies and computational modelling, share knowledge and experience and build professional networks. In addition, several EU projects funded under various programmes (36) supported the training of hundreds of young scientists in non-animal methods. For example, ASPIS is currently setting up an academy of young scientists on animal-free safety assessment of chemicals. The Commission, with financial support from the Parliament, developed a series of e-learning modules on various aspects of Directive 2010/63/EU, including one on how to search for existing non-animal alternatives and one on how to develop alternative methods for regulatory purposes.

2.4.   International activities

The Commission is committed to developing common standards and innovative risk assessment tools internationally (notably in the OECD), and to promoting their use within international frameworks, to shift further away from animal testing, among other objectives. The Commission is actively supporting the development of OECD technical guidelines, also aiming to ensure mutual acceptance of data among OECD and other relevant countries.

Furthermore, the Commission is actively promoting the inclusion of alternative methods, including in vitro methods in the Globally Harmonised System of Classification and Labelling of Chemicals, helping to align international approaches and thus to create a level playing field.

2.5.   Agencies, Commission scientific committees and stakeholders

The Commission relies on a wide network of expert groups, committees and in-house think tanks that provide a wealth of expertise on NAMs that will facilitate their acceptance. The Commission is in the fortunate position to receive advice on world-leading science from the JRC, including the EURL ECVAM. This knowledge is strengthened in the various regulatory areas by the agencies and the Commission scientific committees (37). Further structures exist for example the European Partnership for Alternative Approaches to Animal Testing.

The 2023-2026 work programme of ECHA lists several of its planned activities of the Agency related to NAMs, e.g.:

—	building internal capacity on NAMs by organising training for ECHA scientists and its committees to increase the level of knowledge on NAMs suitable for regulatory needs;

—	becoming more closely involved in scientific projects addressing key aspects for regulatory acceptance (38);

—	continuously developing computational tools that provide information on hazard properties (39);

—	making data sets available for the development of NAMs and joint projects with EFSA on data interoperability and tools integration;

—

increasing cooperation across legislations and jurisdictions within Europe and outside Europe (US Environmental Protection Agency, Health Canada) through platforms such as the European Partnership on Alternative Approaches to Animal Testing (EPAA) and Accelerating the Pace of Chemical Risk Assessment (APCRA); and

—	organising sessions on non-animal methods at key conferences (40).

The European Medicines Agency (EMA) supports the ethical use of animals in the testing of human and veterinary medicinal products across the EU by promoting regulatory acceptance of testing approaches applying the Three Rs principle. It has issued specific guidance in this respect, including:

—	recommendations on methods applying the Three Rs principle in the European pharmacopoeia to help marketing authorisation holders comply with new or revised measures;

—	a scientific review of batch release tests for human and veterinary vaccines and biologicals to ensure that these are aligned with best practice in Three Rs; and

—	a contribution to the development of harmonised guidance and requirements in Europe and globally, by working closely with relevant European and international bodies.

Furthermore, EMA has recently reactivated its dedicated 3Rs Working Party (3RsWP). The 3RsWP provides advice to the EMA’s scientific committees on the use of animals in regulatory testing of medicines and the application of the Three Rs principle. The 3RsWP has set some very ambitious goals (41) for – among others – the promotion of regulatory acceptance of innovative NAMs. EMA also has an Innovation Task Force, which is a multidisciplinary group that provides a forum for early dialogue with applicants on innovative aspects in medicines development and also covers the regulatory acceptance of non-animal methods.

The European Food Safety Agency (EFSA) is considering the development and use of non-animal methods in risk assessment as a critical step for moving towards a new paradigm based on the mechanistic understanding of toxicity and moving away from the use of animals. EFSA has sponsored several projects in various areas such as developmental neurotoxicity, chronic neurotoxicity, development of adverse outcome pathways, NAMs for nanoforms and absorption, distribution, metabolism and excretion. Furthermore, EFSA has published a NAM roadmap (42) with proposals for the development of non-animal methods and new concepts for human risk assessment relevant for regulatory purposes.

The EU’s Scientific Committee on Consumer Safety (SCCS) (43) plays an important role in taking up the legislator’s decision to ban animal tests under the Cosmetics Regulation. The SCCS has been closely following progress in developing and validating alternative methods. The latest revision of the Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation by the SCCS was published in March 2021.

Besides validated alternatives, the SCCS may also accept, on a case-by-case basis, methods that the Committee considers scientifically valid for the safety evaluation of cosmetic substances even if they have not gone through a validation process.

The EPAA was set up by the Commission in 2005. The EPAA brings together all Commission services with activities related to (non-)animal testing for scientific purposes, EU agencies, as well as representatives of the industry covered by the regulatory framework on chemicals and pharmaceuticals, with other stakeholders like animal-welfare NGOs, the Parliament and academic experts. The EPAA’s activities include the Project Platform, where EPAA partners and associates collaborate on projects that support the development, validation, acceptance and implementation of alternatives that apply the Three Rs principle in regulatory testing and decision-making. Furthermore, the EPAA organises an annual conference on activities on these topics. The next annual conference will take place in November 2023 and aims to address the impact of the chemical strategy for sustainability and the pharmaceutical strategy for Europe on innovation and animal testing. The Partners’ Forum gives EPAA members an opportunity to exchange information across sectors and to identify synergies. In addition, it provides grants and awards for outstanding contributions to the development and implementation of alternatives to animal testing, such as the EPAA Refinement Prize, which supports students and young scientists who have done outstanding work in the field of alternative approaches.

2.6.   Progress following the ECI ‘Stop Vivisection’ of 2015

In 2015, the ECI ‘Stop Vivisection’ asked the Commission to put forward a new proposal aimed at phasing out the practice of animal experimentation. The Commission responded with a number of actions, which have been followed through:

1.

Accelerating progress in the Three Rs through knowledge sharing: The ETPLAS (44) platform was created to allow a more systematic sharing of knowledge on the application of Three Rs. Six open access training e-modules are currently accessible via the platform, while thirteen additional modules will be finalised by end of 2024.

2.

Development, validation and implementation of new alternative approaches: The Commission followed up to its commitment to support the development, validation and implementation of alternative approaches for regulatory and research use by continuing the funding of alternative approaches and with activities of EURL ECVAM on method validation. Collaborations like EPAA and APCRA support the Commission’s efforts.

3.

Monitoring compliance with Directive 2010/63/EU: The Commission and its agencies continued promoting the use of alternative approaches, e.g. for pyrogenicity testing of vaccines and biologicals (45). The Commission also updated the Test Method Regulation to foster the use of internationally accepted alternative methods.

4.

Engaging in a dialogue with the scientific community: The Commission committed to organise a conference engaging the scientific community and stakeholders in a debate on how to advance towards the goal of phasing out animal testing. The Commission organised two conferences on this topic in 2016 and in 2021 (46).

3.   EVALUATION OF THE PROPOSALS IN THE INITIATIVE AND RESPONSES

The Commission has carefully analysed the three main objectives of the ECI.

3.1.   Objective 1: Protect and strengthen the cosmetics animal testing ban

Objective 1 is described in the ECI as ‘Protect and strengthen the cosmetics animal testing ban. Initiate legislative change to achieve consumer, worker, and environmental protection for all cosmetics ingredients without testing on animals for any purpose at any time’. In the annex to the initiative, this objective is broken down into the below four points.

1.	Immediately implement the existing EU bans on animal testing for cosmetics and the marketing of ingredients tested on animals.

2.	Clarify that the assessment of cosmetics ingredients must rely on non-animal data and that animal data must be rejected, regardless of the location and purpose of animal tests.

3.	Change legislation to ensure a chemical safety assessment of cosmetic ingredients, including for workers’ health and the environment, without animal testing.

4.	Devise a robust assessment strategy for cosmetics ingredients based on non-animal methods.

Response to objective 1:

The Commission responds to the ECI as set out below. — The Commission emphasises that the animal testing ban for cosmetics ingredients and the marketing ban for cosmetic products containing ingredients tested on animals has been fully implemented under the Cosmetics Regulation. — Already now, animal testing is banned for the assessment of cosmetics ingredients under the Cosmetics Regulation. — The Commission does currently not intend to propose legislative changes to the Cosmetics Regulation nor to the REACH Regulation as regards the testing of cosmetics ingredients. The interface between the two Regulations is currently under scrutiny by the General Court in two cases brought against ECHA. The Commission will analyse the judgments, once available, and take them into account when deciding on the need for legislative changes. — Furthermore, as part of the targeted revision of the REACH Regulation, the Commission intends to propose replacing some information requirements based on animal testing with non-animal methods, where possible. — The request for a robust assessment strategy for cosmetics ingredients based on non-animal methods appears to be similar to the requests made under objective 2 of the ECI for steps to develop and implement non-animal approaches to chemical safety assessments and for an aligned transition in the regulatory space to non-animal approaches. Therefore, the request is replied to in section 3.2.

Already now, the Cosmetics Regulation bans the placing on the market of cosmetic products that have been tested on animals to meet the requirements of this Regulation. The ban, which has been fully applicable since March 2013, also concerns cosmetics ingredients tested on animals for the purpose of that Regulation. Data generated through animal testing performed to meet cosmetics requirements of non-EU countries cannot be relied on in the EU for the assessment of cosmetics.

However, most ingredients used in cosmetic products are also used in other consumer and industrial products. Animal testing may be necessary to ensure compliance with rules that apply to these products. In such cases, the Commission clarified (47) that animal testing that has been motivated by compliance with non-cosmetics-related rules should not trigger the marketing ban for cosmetics. Such data can be relied on for the cosmetics safety assessment under the Cosmetics Regulation if they are relevant for this assessment (48).

Chemical substances used as cosmetics ingredients are also subject to requirements under the REACH Regulation, if produced at 1 tonne or more per year, for assessing hazards and risks to human health and the environment. In October 2014, the Commission, in cooperation with ECHA, clarified (49) the relationship between the marketing ban and the information requirements under the REACH Regulation. For chemicals that are not solely used in cosmetics, animal testing is permitted, as described above, to fulfil the requirements under the REACH Regulation.

The Cosmetics Regulation requires an assessment of the risks to consumers and to professionals (50). For these assessments, animal testing is prohibited. The REACH Regulation, however, additionally requires an assessment of the risks to workers exposed to the substance and the risks to the environment. Therefore, registrants of chemicals exclusively used in cosmetics may need to perform animal testing to satisfy the requirement to assess the risks to workers and the environment under the REACH Regulation. However, as is the case for all substances registered under the REACH Regulation, registrants must provide the required information, wherever possible, by using alternatives to animal testing (e.g., computer modelling, read-across, weight of evidence). Animal testing remains the last resort, and can, and in fact frequently is waived in accordance with the REACH Regulation.

The ECI asks for legislative changes and to expand the scope of the Cosmetics Regulation to cover the assessment of the risks to workers’ health and the environment. This would require fundamental changes to this Regulation and to the REACH Regulation. This would also be the case if changes were to be made to the REACH Regulation only, i.e. a ban on animal testing for cosmetics ingredients were to be introduced under the REACH Regulation only. Changes to any of the two Regulations would lead to information gaps on risks to workers and the environment since, as indicated above, it is not yet considered sufficient to perform safety assessments for human health and the environment without any animal testing due to the lack of accepted alternative methods. It could also lead to cosmetic ingredients that are in principle safe being removed from the market because it is impossible to fully demonstrate their safety. In summary, any legislative changes would require progress in developing animal-free assessment methods and suitable criteria for their uptake and an in-depth analysis of the impacts.

The above interpretation of the interface between the Cosmetics Regulation and the REACH Regulation is currently under scrutiny by the General Court in two cases brought against ECHA. A registrant challenges the obligation to perform animal testing, requested by ECHA in dossier evaluation decisions under the REACH Regulation. The judgments are expected in the course of 2023 and may have consequences for the current interpretation underlying the Commission’s response to this ECI.

Case T-655/20 and Case T-656/20 (Symrise v ECHA) The applicants apply for annulment of two decisions of the Board of Appeal of ECHA. In these decisions, the Board of Appeal had confirmed the ECHA’s request for certain tests involving animal testing for chemicals that are solely used in cosmetics. Among other pleas, the applicant, supported by NGOs and companies active in the production of cosmetics, claims that by requesting tests on vertebrate animals for the assessment of the risks to workers’ health, and by failing to take account of the safety of the substance as assessed under the Cosmetics Regulation into account, ECHA committed a manifest error of assessment and misinterpreted the REACH Regulation.

3.2.   Objective 2: Transform EU chemicals legislation

The ECI calls on the Commission to transform EU chemicals legislation and to ensure that human health and the environment are protected by managing chemicals without adding of new animal testing requirements. The initiative requests under objective 2 to put in place concrete steps to develop, validate, and implement human-relevant, non-animal approaches for the identification of toxic chemicals. It asks to commit to a full transition away from animal testing, ensure an uptake of non-animal methods that is aligned between all relevant regulatory agencies with administrative responsibility for chemicals, biocides, plant protection products, pharmaceuticals, and other products and to adapt regulatory frameworks to ensure a rapid uptake of NAMs. It further requests to ensure that test requirement deadlines are not applied at the expense of scientific rigour or human and environmental safety by allowing a default fallback to reliance on unreliable tests on animals. In essence, the objectives of the initiative correspond to putting in place a strategy or roadmap for a transition away from animal testing. Points mentioned under objective 2, which have been further detailed in a meeting with the Commission on 17 March 2023, appear to partly overlap with those under objective 3 asking to ‘plot a roadmap’ and further to prioritise the funding for developing and validating non-animal methods, also for regulatory purposes, and to coordinate the uptake of the methods. In particular, the request for concrete steps in objective 2 corresponds to setting up a roadmap towards phasing out animal testing for chemical safety assessments.

Response to Objective 2:

A roadmap towards ultimately phasing out animal testing for chemical safety assessments The Commission will immediately launch the work to develop a roadmap that will outline milestones and specific actions, to be implemented in the short to longer term, to reduce animal testing and that would be pre-requisites for a transition towards an animal-free regulatory system under relevant pieces of chemical legislation (e.g. REACH, Biocidal Product Regulation, Plant Protection Products Regulation and human and veterinary medicines). Core of the roadmap will be to analyse and to describe the necessary steps to replace animal testing in pieces of legislation that currently require animal testing for chemical safety assessments. The roadmap will outline the path to expand and accelerate the development, validation and implementation of non-animal methods as well as means to facilitate their uptake across legislations. The Commission intends to discuss with Member States and stakeholders elements of the roadmap at a workshop in the second half of 2023 and to present the progress made at a second workshop in the second half of 2024. It is intended to finalise the work on the roadmap in the first quarter of the term of the next Commission. When drawing up the roadmap, the Commission will work closely with its agencies, the Member States and relevant stakeholders from NGOs, industry and research. The roadmap’s development will be supported by assessments that were carried out by the Joint Research Centre, EFSA’s work on non-animal approaches, the EFSA roadmap and the expertise of ECHA, EFSA and EMA.

The roadmap will include and build on the below elements to support the transition towards chemical safety assessments based on non-animal testing.

1.

Replacing animal testing: While substantial progress has been made during the recent years to develop alternative methods to animal testing, it is still not possible to replace animal testing for chemical safety assessments for all (eco-)toxicological endpoints. For some endpoints, further research is necessary. For other endpoints, non-animal testing is currently not satisfying fully the regulatory needs, e.g. as regards the quantitative assessments of hazards and risks. It is therefore necessary to analyse for each (eco-)toxicological endpoint the options to replace animal testing, identify gaps that have to be closed and development needs. Furthermore, in some cases, it might be necessary to define data requirements in legislation differently so that non-animal methods can be used to fulfil regulatory needs. This analysis will be a core element of the roadmap, which will also include action points and milestones to achieve the ultimate goal of phasing out animal testing for the different endpoints.

2.

Joining forces - stakeholder involvement: Involving stakeholders is crucial for pooling the scientific knowledge that forms the basis of the roadmap and essential to receive support from Member States, agencies and stakeholders from industry, NGOs and research. As a first step, from 31 May to 1 June 2023 (51), the Commission, together with ECHA and several stakeholders, organised a workshop that took stock of the scientific developments on non-animal testing, and discussed requirements such testing need to fulfil in a regulatory context. Organisers of the ECI participated at the workshop. Participants of the workshop voiced support for developing a roadmap. towards phasing out animal testing.Continuous stakeholder involvement will be guaranteed with, among other things, a set of further workshops: — the Commission will organise a workshop in the second half of 2023 to discuss the steps necessary to replace animal testing for each toxicological endpoint and the elements of a roadmap; — the Commission intends to organise a second workshop in the second half of 2024 to present the progress made on developing a roadmap as well as to receive input from Member States and stakeholders; and — further workshops focusing on scientific and regulatory aspects will be organised in collaboration with the EPAA or by the agencies.

3.

Strengthen collaboration of agencies and expert committees: The Commission is currently preparing a proposal for adoption in 2023 entitled ‘Streamlining EU scientific and technical work on chemicals through the EU agencies’ that has the purpose to enhance the collaboration of the agencies and to increase their efficiency by making full use of synergies in the assessment of chemicals. Furthermore, the Commission will, as part of the roadmap, analyse the strengths and weaknesses of the current landscape of agencies, committees and working groups that provide advice on non-animal methods. Such action, which will be finished together with the roadmap, could also explore opportunities for a stronger collaboration and analyse possibilities to accelerate the transfer of available scientific expertise to legislation.

4.

Advisory scientific committee on non-animal methods: As part of the work under under the roadmap, the Commission will analyse the need and feasibility of an expert scientific committee to provide advice on the development of non-animal approaches and their uptake and use in the regulatory context. The analysis will be presented together with the roadmap.

5.

Acceptance of methods: The Commission will analyse, as part of the roadmap, ways to accelerate the acceptance of new non-animal methods, while taking into account the importance of mutual acceptance of data across different jurisdictions. This includes the need to increase validation but also the regulatory uptake of non-animal methods.

6.

International dimension: The roadmap will outline ways to improve outreach activities with non -EU partner countries and multilateral organisations to foster the development and acceptance of non-animal testing methods for regulatory purposes, such as the underlying classification methods for substances and mixtures under the UN Globally Harmonised System of Classification and Labelling of Chemicals.

7.

Agencies involvement in international forums: The EU agencies, such as EFSA, ECHA or EMA, have outstanding expertise in non-animal methods. The roadmap will analyse, in close collaboration with the agencies, possibilities to increase the agencies’ visibility and impact in international forums, such as OECD at the regional and the WHO at the international level. The collaboration of regulators from the US, Canada, Europe and others in the APCRA (Accelerating the Pace of Chemical Risk Assessment) project is facilitating alignment in international forums. This work is critical to enable progress towards phasing out animal testing in the international context, i.e. in light of globally harmonised classifications and mutual acceptance of data.

8.

Improve availability and accessibility of information: Access to information on NAMs, available knowledge bases and tools is key to accelerating the uptake of non-animal approaches. The Commission will propose in 2023 a Regulation on chemicals data that will improve accessibility to information on chemicals. Furthermore, the Commission will analyse by end of 2024, how to facilitate access to information such as upcoming events, calls, but also to guidance, e.g. through dedicated platforms and interactive communication tools. Increased availability and accessibility of information on non-animal methods will benefit industry and authorities when replacing animal testing, inform the general public and support the scientific community when developing new methods.

9.

Outreach to scientific community and stakeholders: An exchange with all stakeholders, including the scientific community, is vital for accelerating the replacement of animal testing and for gaining support for basing chemical assessments on non-animal methods. The Commission will therefore increase its outreach to stakeholders and the scientific community, with support of its agencies, to receive the necessary input on how to replace animal testing with non-animal approaches, e.g. via the organisation of workshops (point 2), the annual conference under the umbrella of EPAA (section 2.5) or contributions to conferences.

Furthermore, as part of the revision of the REACH Regulation, the Commission intends to assess all possibilities to replace information requirements based on animal testing with non-animal methods. New animal-based information requirements would be introduced only as a last resort.

3.3.   Objective 3: Modernise science in the EU – Commit to a legislative proposal plotting a roadmap to phase out all animal testing

The ECI asks to modernise science in the EU by ultimately phasing out all animal testing including for research and educational purposes. The initiative proposes reaching this goal through a ‘legislative proposal plotting a roadmap to phase out all animal testing in the EU before the end of the current legislative term’. Such a proposal should include targets regarding ‘reduction in numbers of animals used, investments in advanced non-animal models and infrastructures, education and training synergy, and regulatory acceptance of non-animal methods. The description under the initiative’s objective 3 appears to overlap with objective 2. The initiative also requests to endorse the desirability of phasing out animal testing in science.

Response to Objective 3:

The Commission responds to the ECI as set out below. — The Commission is proposing a set of action points to accelerate the reduction of animal testing in research, education and training, including activities that will increase cooperation with Member States. — Furthermore, the Commission will continue to support research on alternatives to animal testing with substantial funding.

The Commission reiterates that it shares the goal of phasing out animal testing, as soon as it is scientifically possible, as also mentioned in recital 10 of Directive 2010/63/EU, however it does not consider that a legislative proposal is the right way forward towards phasing out all animal testing. Directive 2010/63/EU lays down measures to protect animals used for scientific or educational purposes. It does not provide a legal framework to set up research programmes or to set reduction targets for the number of animals used, or to stimulate investments in advanced non-animal models and infrastructures, education and training synergies or the regulatory acceptance of non-animal methods. Advances in the mentioned areas can rather be reached by building and extending on existing programmes and developing specific actions as suggested below. In addition, progress in science via research programmes requires strong support from Member States. This is even more evident for actions in education and training, an area for which the Member States are responsible. Similarly, the uptake of validated methods can only be achieved with their involvement.

Setting reduction targets appears to be useful in policy areas where the possibilities to implement a policy goal can be clearly mapped out. However, this is not the case in research, where scientific progress and innovation are unpredictable, and rely on the best available methods, technologies and knowledge. In addition, setting a universal reduction target may not account for the diversity of research needs. Considerable advances have been made in developing alternatives, but animal models remain unavoidable at the moment to understand some more complex biological or physiological processes involved in health, disease and biodiversity. The Commission reiterates that at this stage, it is not possible to predict when scientifically valid methods able to replace particular animal procedures in research will become available. Consequently, setting reduction goals seems unrealistic and these would need to be constantly adjusted.

As mentioned above in section 3.2 (point 5), as a response to the requests of the initiative under objective 2, the Commission will propose to draw up a roadmap that includes the development and validation of non-animal methods for regulatory purposes as well as their uptake and acceptance in regulatory procedures for chemicals safety assessment as soon as they are available. As regards research funding, the EU is already making considerable investments in advancing non-animal approaches. This has been briefly described in section 2.3. The Commission intends to keep up the pace of funding alternatives to animal approaches.

Finally, the Commission will complement its commitments to the roadmap for chemicals safety assessment described in section 3.2 with the below specific action points to accelerate the reduction of animals used in research, education and regulatory acceptance.

1.

Further improving coordination with Member States: The Commission is exploring the possibility of developing a European Research Area (ERA) policy action to reduce animal uses in research and regulatory testing. The involvement of a critical mass of Member States is crucial to accelerate the uptake of alternative methods and commit to a reduction of animal testing. This action would be a direct and potentially impactful answer to the request of the initiative to phase out animal testing in research. It could mobilise Member States, under the Commission’s leadership to streamline their national and regional policies to reduce animal testing, while accelerating the development, validation and uptake of alternative methods. This ERA policy action would also inform all relevant stakeholders of the applicability of non-animal methods, as they become available. The Commission presented this proposal to the Member States on 25 May 2023. Member States are currently assessing their interest in participating in such action.

2.

Continued EU funding to alternatives and visibility: The Commission already provides substantial support to research on alternatives to animal testing and will continue to do so. As mentioned in section 2.3, the 2023-2024 work programme of Horizon Europe Work Programmes 2023-2024 and the Innovative Health Initiative cover several relevant topics. The Commission also intends to include alternatives to animal testing in the next Horizon Europe strategic planning 2025-2027.

3.	Exploratory workshop(s): The Commission intends to organise one or more workshops with experts to determine future priority areas of research. The workshop(s) will be held before mid 2025 and might be part of the workshops announced in section 3.2.

4.	Education, training and awareness: As indicated in section 2.3, an academy of young scientists in alternatives to animal testing was set up recently under the Horizon 2020 ASPIS cluster. The Commission is exploring ways to continue this initiative.

4.   CONCLUSION AND OUTLOOK

The ECI ‘Save cruelty-free cosmetics – Commit to a Europe without animal testing’ echoes the public concerns about the use of animals for scientific purposes, including for chemical safety assessments under various pieces of legislation.

The Commission shares the view that all animal testing for regulatory purposes should be phased out. However, this is a long-term goal that will only be reached step by step and that requires further scientific developments in identifying hazards and risks solely based on non-animal methods. In the short and medium term, animal testing remains important for assessing risks of chemicals to human health and the environment. Where possible, current revisions of several pieces of chemical legislation foster the use of non-animal approaches. For instance, the Commission intends to replace some animal-based methods currently required under the REACH Regulation and to introduce non-animal methods.

Reducing animal testing in the short and medium term and phasing out such tests in the long term will require concerted and aligned action by the Commission and its agencies, Member States, the research community and stakeholders. It further demands a clear view on the steps needed to phase out animal testing. The Commission will therefore immediately start with its work to develop a roadmap that will outline milestones and specific actions, to be implemented from the short to longer term, to reduce animal testing with the aim to transition towards an animal-free regulatory system under all relevant pieces of chemical legislation. This roadmap will analyse necessary changes in regulatory approaches and to give the right impetus for the development, validation and implementation of non-animal methods and their rapid uptake in regulatory procedures for chemicals safety assessment. Once defined, this roadmap could serve as a model for other policy areas. The main Commission actions that will feed into this roadmap consist of a set of legsislative and non-legislative actions (outlined in detail in section 3.2):

—	A step-by-step analysis of each (eco-)toxicological endpoints with the aim to define necessary actions and milestones to phase out animal testing;

—	A full involvement of stakeholders in workshops in 2023 and 2024 that will discuss the roadmap. ;

—	Strengthened collaboration of agencies and expert committees, among others through the adoption of the Commission proposal for adoption in the second half of 2023 entitled ‘Streamlining EU scientific and technical work on chemicals through the EU agencies’;

—	Improving accessibility to information on NAMs, by, among others, a Commission proposal in the second half of 2023 for a Regulation on chemicals data that will improve accessibility to information on chemicals;

—	Perform an analysis, as part of the roadmap, of ways to accelerate the validation and acceptance of new non-animal methods;

—	Analyse the possible need and feasibility of an expert scientific committee to provide advice on the development of non-animal approaches and their uptake and use in the regulatory context;

—	Analyse ways to improve outreach activities with non-EU partner countries and multilateral organisations, as well as to increase the visibility of EU agencies in relevant international forums.

Similarly, to reach the goal of modernising science, further development of non-animal methods is required. Therefore, the Commission will continue its strong support to the development of alternative approaches with appropriate funding. The Commission is also exploring the possibility of coordinating Member States activities in this field.

The Commission does not share the view that a legislative proposal is the right tool to reach the goal of phasing out the use of animals in research and education. Science has not yet progressed sufficiently to offer adequate non-animal solutions for understanding completely health and diseases or the biodiversity. Therefore, the Commission proposes to develop specific measures for accelerating the reduction of animal testing in science. These actions are outlined in section 3.3 in the area of research, education and training to further strengthen the efforts towards phasing out animal testing.

Finally, the Commission, through a proposed new ERA policy action, invites the Member States, acting within their powers, and in particular for research and educational purposes, to step up their efforts to reduce animal methods and to actively participate in developing alternative approaches.

---

(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)  https://europa.eu/citizens-initiative/initiatives/details/2021/000006_en

(3)  Commission Implementing Decision (EU) 2021/1136 of 30 June 2021 on the registration of the European citizens’ initiative entitled ‘Save Cruelty-free Cosmetics – Commit to a Europe without Animal Testing’, pursuant to regulation (EU) 2019/788 of the European Parliament and of the Council.

(4)  The annex to ‘Save cruelty-free cosmetics – Commit to a Europe without animal testing’ ECI provides further procedural details about the initiative, including the required thresholds, and the number of statements of support.

(5)  Meeting of the organisers of the ‘Save cruelty-free cosmetics’ European citizens' initiative with the European Commission (europa.eu); https://audiovisual.ec.europa.eu/en/reportage/P-060517

(6)  ECI-Hearing ‘Save cruelty-free cosmetics – Commit to a Europe without animal testing’; https://www.europarl.europa.eu/committees/en/eci-hearing-save-cruelty-free-cosmetics-/product-details/20230524ECI00141

(7)  Communication from the Commission to the European Parliament and the Council on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics (COM/2013/0135 final).

(8)  https://webgate.ec.europa.eu/envdataportal/content/alures/section1_number-of-animals.html

(9)  The 2020 decrease is also partially due to reduced activities from lockdowns and cancelled or postponed projects as a result of the COVID-19 pandemic.

(10)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

(11)  Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes (OJ L 276, 20.10.2010, p. 33).

(12)  EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) (europa.eu)

https://joint-research-centre.ec.europa.eu/eu-reference-laboratory-alternatives-animal-testing-eurl-ecvam_en

(13)  See latest statistics report https://ec.europa.eu/environment/chemicals/lab_animals/reports_en.htm

(14)  Public statistics database https://webgate.ec.europa.eu/envdataportal/content/alures/section1_number-of-animals.html

(15)  List of guidance documents on REACH is available on the ECHA’s website: https://echa.europa.eu/guidance-documents/guidance-on-reach.

(16)  Council Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 142, 31.5.2008, p. 1).

(17)  Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).

(18)  Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (OJ L 167, 27.6.2012, p. 1).

(19)  Commission Delegated Regulation (EU) 2021/525 of 19 October 2020 amending Annexes II and III to Regulation (EU) No 528/2012 of the European Parliament and of the Council concerning the making available on the market and use of biocidal products (OJ L 106, 26.3.2021, p. 3).

(20)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

(21)  Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community 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).

(22)  Proposal for a Regulation of the European Parliament and of the Council laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency (COM/2023/193)

(23)  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).

(24)  https://vichsec.org/en/home.html

(25)  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (OJ L 117, 5.5.2017, p. 1).EUR-Lex - 52020DC0381 - EN - EUR-Lex (europa.eu)

(26)  Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

(27)  COM/2019/640. https://commission.europa.eu/document/daef3e5c-a456-4fbb-a067-8f1cbe8d9c78_en

(28)  Chemical safety – better access to chemicals data for safety assessments (europa.eu)

(29)  Commission Recommendation (EU) 2022/2510 of 8 December 2022 establishing a European assessment framework for ‘safe and sustainable by design’ chemicals and materials

(30)  Procedure File: 2021/2784(RSP) | Legislative Observatory | European Parliament (europa.eu)

(31)  Animal-free Safety assessment of chemicals: Project cluster for Implementation of novel Strategies. (aspis-cluster.eu)

(32)  Partnership for the Assessment of Risks from Chemicals | Parc (eu-parc.eu)

(33)  Marx-Stoelting, P., Rivière, G., Luijten, M. et al. A walk in the PARC: developing and implementing 21st century chemical risk assessment in Europe. Arch Toxicol 97, 893–908 (2023). https://doi.org/10.1007/s00204-022-03435-7

(34)  European Commission Decision C(2023) 2178. Horizon Europe Work Programme 2023-2024. 4. Health. 31 March 2023

(35)  https://european-union.europa.eu/institutions-law-budget/institutions-and-bodies/search-all-eu-institutions-and-bodies/innovative-health-initiative-joint-undertaking-ihi-ju_en

(36)  E.g. under Horizon 2020 Societal Challenge 1, Horizon Europe Health Cluster, the Innovative Medicines Initiative and the Innovative Health Initiative, Marie Curie networks, etc

(37)  E.g. the Scientific Committee for Consumer Safety (SCCS), the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) or the EURL ECVAM Scientific Advisory Committee

(38)  E.g Accelerating the Pace of Chemical Risk Assessment (APCRA), EU ToxRisk, ASPIS, PARC and MATCHING projects,)

(39)  E.g. the OECD QSAR Toolbox or the QSAR Assessment Framework work at OECD

(40)  E.g. SETAC Annual Meetings, EUROTOX, QSAR 2023

(41)  Consolidated 3-year work plan for the Non-clinical domain including the priorities for 2023 (europa.eu)

(42)  Development of a Roadmap for Action on New Approach Methodologies in Risk Assessment EFSA Journal 2022;19(6):EN-7341

(43)  The Committee provides Opinions on health and safety risks (chemical, biological, mechanical and other physical risks) of non-food consumer products (e.g. cosmetic products and their ingredients, toys, textiles, clothing, personal care and household products) and services (e.g. tattooing, artificial sun tanning).

(44)  https://learn.etplas.eu/ Education and Training Platform for Laboratory Animal Science

(45)  Joint EDQM-EPAA Event: The future of pyrogenicity testing: phasing out the rabbit pyrogen test - European Directorate for the Quality of Medicines & HealthCare

(46)  Non-animal approaches - Publications Office of the EU (europa.eu) (2017); Towards replacement of animals for scientific purposes - Publications Office of the EU (europa.eu) (2021)

(47)  Communication from the Commission to the European Parliament and the Council on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics, 11.3.2013, COM(2013)135

(48)  Article 10 (3) of Regulation 1223/2009/EC

(49)  Interface between REACH and Cosmetics regulations, Factsheet, ECHA-14-FS-04-EN; https://echa.europa.eu/documents/10162/13628/reach_cosmetics_factsheet_en.pdf/2fbcf6bf-cc78-4a2c-83fa-43ca87cfb314

(50)  Professionals are understood as persons using cosmetic products as part of their business (e.g. hairdressers), while workers manufacture the ingredients or the products on an industrial site.

(51)  https://echa.europa.eu/-/echa-s-workshop-opens-way-for-animal-testing-free-chemicals-regulation

Non-opposition to a notified concentration

(Case M.11144 – COLT TECHNOLOGY SERVICES GROUP / LUMEN EMEA BUSINESS)

(Text with EEA relevance)

(2023/C 290/02)

On 9 August 2023, the Commission decided not to oppose the above notified concentration and to declare it compatible with the internal market. This decision is based on Article 6(1)(b) of Council Regulation (EC) No 139/2004 (1). The full text of the decision is available only in English and will be made public after it is cleared of any business secrets it may contain. It will be available:

—	in the merger section of the ‘Competition policy’ website of the Commission (https://competition-cases.ec.europa.eu/search). This website provides various facilities to help locate individual merger decisions, including company, case number, date and sectoral indexes,

—	in electronic form on the EUR-Lex website (http://eur-lex.europa.eu/homepage.html?locale=en) under document number 32023M11144. EUR-Lex is the online point of access to European Union law.

---

(1)  OJ L 24, 29.1.2004, p. 1.

OPINION OF THE EUROPEAN CENTRAL BANK

of 5 July 2023

on a proposal for economic governance reform in the Union

(CON/2023/20)

(2023/C 290/03)

Introduction and legal basis

On 12 May and 27 June 2023 the European Central Bank (ECB) received requests from the Council of the European Union and the European Parliament, respectively, for an opinion on a proposal for a Regulation of the European Parliament and of the Council on the effective coordination of economic policies and multilateral budgetary surveillance and repealing Council Regulation (EC) No 1466/97 (hereinafter, the ‘proposed new Stability and Growth Pact (SGP) preventive arm Regulation’) (1). On 12 May 2023 the ECB received requests for an opinion from the Council of the European Union on a proposal for a Council Regulation amending Council Regulation (EC) No 1467/97 on speeding up and clarifying the implementation of the excessive deficit procedure (hereinafter, the ‘proposed amendments to the SGP corrective arm Regulation’) (2) and on a proposal for a Council Directive amending Council Directive 2011/85/EU on requirements for budgetary frameworks of the Member States (hereinafter, the ‘proposed amendments to the budgetary frameworks Directive’) (3) – the latter, together with the proposed new SGP preventive arm Regulation and the proposed amendments to the SGP corrective arm Regulation hereinafter referred to as the ‘Commission proposals’.

The ECB’s competence to deliver an opinion on the proposed new SGP preventive arm Regulation and on the proposed amendments to the budgetary frameworks Directive is based on Articles 127(4) and 282(5) of the Treaty on the Functioning of the European Union, since the effective coordination of economic policies and multilateral budgetary surveillance are relevant to the primary objective of the European System of Central Banks (ESCB) to maintain price stability under Articles 127(1) and 282(2) TFEU and Article 2 of the Statute of the European System of Central Banks and of the European Central Bank (hereinafter the ‘Statute of the ESCB’).

The ECB’s competence to deliver an opinion on the proposed amendments to the SGP corrective arm Regulation is based on the second subparagraph of Article 126(14) TFEU, which provides that the Council shall, after consulting, inter alia, the ECB, adopt the appropriate provisions on the excessive deficit procedure, which is also relevant to the abovementioned primary objective of the ESCB.

In accordance with the first sentence of Article 17.5 of the Rules of Procedure of the European Central Bank, the Governing Council has adopted this opinion.

General observations

The ECB welcomes the Commission proposals on the reform of the Union’s economic governance framework. The reform aims to safeguard the sustainability of public debt, the countercyclicality of fiscal policy, to adopt a medium-term approach to budgetary policies, as well as to achieve simplification and increased national ownership of the framework. It also recognises that reforms, investment and fiscal sustainability are mutually reinforcing and should therefore be fostered with an integrated approach. Finally, the reform aims to ensure more effective enforcement. To support the achievement of these objectives, the ECB offers some specific, technical observations and suggestions on the Commission proposals, with a view to further enhance the new framework and ensure it will be more transparent and predictable.

A robust Union framework for economic and fiscal policy coordination and surveillance is in the profound and overwhelming interest of the European Union, the Member States and, in particular, the euro area (4) . The ECB emphasises the importance of sustainable fiscal positions for price stability and sustainable growth in a smoothly functioning Economic and Monetary Union (EMU) (5). The reform of the Union’s economic governance framework can offer a realistic, gradual and sustained adjustment of public debt, combined with facilitating necessary national structural policies.

The ECB urges the Union legislators to come to an agreement on the reform of the Union’s economic governance framework as soon as possible, and at the latest by the end of 2023. As the general escape clause contained in the SGP will be deactivated by then (6), such an agreement would be critical in order to anchor expectations for debt sustainability and sustainable and inclusive growth. Failure to swiftly agree on and put in place a credible, transparent and predictable fiscal framework could create uncertainty and unduly delay necessary fiscal adjustment and the impetus for reforms and investment.

The ECB emphasises the following reasons for a reformed economic governance framework. First, increased government debt ratios and debt heterogeneity in the aftermath of the coronavirus pandemic reinforce the need for effective coordination of fiscal positions via the SGP. A realistic, gradual and sustained adjustment of public debt taking into account the prevailing outlook for growth and inflation is important to ensure fiscal sustainability and in order to rebuild fiscal space ahead of eventual downturns. Second, it is essential to make fiscal policy more countercyclical. Determined action during recessions is required to avoid adverse economic developments, but it is also crucial that buffers are rebuilt once the economy is firmly back on track, to ensure debt sustainability. By effectively contributing to macroeconomic stabilisation in times of large shocks, countercyclical fiscal policy supports monetary policy in achieving price stability over the medium term. Third, it is essential that the economic governance framework sets preconditions for economic policies to become more growth friendly. Structural reforms, investment, and fiscal sustainability should be better integrated into fiscal and macroeconomic surveillance, including under the macroeconomic imbalance procedure (MIP) (7). Moreover, addressing the challenges of the green and digital transitions, in particular meeting the Union’s and Member States’ climate commitments under international and EU law (8), will require significant private and public investment, facilitated by complementary structural policies. A credible stabilisation of public debt ratios requires growth friendly economic policies, including public investment, which need to be appropriately incentivised in the reformed economic governance framework of the Union. Indeed, if effectively implemented, NextGenerationEU, and in particular the Recovery and Resilience Facility, will support Member States in addressing these challenges and demonstrate the potential of Union-wide action. But greater resources and investment at Union level will be needed, as well as sustained, nationally financed investment, requiring either additional sources of revenue or a reprioritisation of expenditure, notably in Member States with elevated debt ratios. Fourth, going forward the ECB would welcome further progress on euro area-related aspects of the Union’s economic governance framework, such as a more effective coordination of the euro area fiscal stance and the establishment of an appropriately designed permanent central fiscal capacity. More broadly, completing the economic and institutional architecture of the EMU remains essential to strengthen the euro area’s shock-absorption capacity and to foster stability and growth (9).

Specific observations

1.   Public debt sustainability and fiscal adjustment

1.1.   The role of debt sustainability analysis

1.1.1.

The ECB understands that under the proposed new SGP preventive arm Regulation, the Debt Sustainability Analysis (DSA) prepared by the Commission will play an important role in designing the technical trajectories for net government expenditure put forward by the Commission to provide guidance to the Member States (10). The Commission’s DSA is a valuable tool in identifying fiscal risks that are not sufficiently captured in recorded debt levels, for example, future costs related to ageing, contingent liabilities, and the maturity composition of debt. To ensure the replicability, predictability and transparency of the DSA and a consistent implementation of the framework across Member States and time, the ECB emphasises the need to specify the methodology underpinning the Commission’s DSA in consultation with, and supported by, the Member States. Moreover, the ECB would also see merit in consulting the European Fiscal Board on this methodology.

1.1.2.

The ECB welcomes that the Commission’s technical trajectory focuses on a net expenditure path which would, in principle, not rely on annual real-time estimates of the unobservable output gap. This has the potential to improve the countercyclicality of fiscal policy, including the fluctuation of revenues arising from cyclical conditions. To further enhance the clarity of the Commission proposals, the ECB recommends that the definition of ‘net expenditure’ is further specified (11) to clarify the following aspects. The definition should: (a) explain whether the net expenditure path would be defined in nominal terms or in real terms; (b) clarify and evaluate the methodology to calculate discretionary revenue measures that are to be deducted from gross expenditure and (c) clarify the extent to which the indicator’s computation would rely on observable items, in particular by clarifying the methodology to compute the cyclical elements of unemployment benefit expenditure.

1.1.3.

The proposed new SGP preventive arm Regulation requires that the technical trajectory for net expenditure ensures that the public debt ratio is put or remains on a plausibly downward path or stays at prudent levels (12). The Commission is required to assess and publish its analysis of plausibility and the underlying data (13). The ECB recommends that the key parameters and assumptions underlying the methodology for the assessment of plausibility should be further elaborated in the Commission proposals (14). Moreover, the ECB welcomes and supports the fact that the Commission’s report to the Economic and Financial Committee, containing the technical trajectories, will be made public prior to the preparation by the Member States of their national medium-term fiscal-structural plans (hereinafter, the ‘national plans’) (15). In addition, the ECB recommends that a common framework is developed in respect of the ‘sound and verifiable economic arguments’ that Member States must put forward in their national plans whenever they include a net expenditure trajectory higher than the one put forward by the Commission (16).

1.2.   Safeguards

The ECB recalls that Article 126(2), point (b), TFEU refers to situations where the ratio of government debt to gross domestic product (GDP) is ‘sufficiently diminishing and approaching the reference value at a satisfactory pace’ (17). In view of the need to avoid that debt stabilises at high levels, the ECB welcomes the fact that the Commission proposals include some safeguards that support debt and deficit reduction, notably by ensuring that the fiscal trajectory envisages a lower public debt ratio at the end of the planning horizon than at the start of the technical trajectory, by avoiding backloading of the fiscal adjustment to the outer years of the adjustment period, and by proposing a minimum adjustment for the years in which the deficit is expected to exceed the 3 % reference value (18). The ECB understands that the issue of safeguards is subject to ongoing discussions and considers that a balance is needed between complexity and ownership on the one hand and effectiveness of debt reduction on the other hand to ensure that debt is put on a sufficiently diminishing path that is appropriately differentiated.

2.   National medium-term fiscal-structural plans

2.1.   Reforms and investments

Productive investment is a prerequisite for economic growth which would support the long-term sustainability of public finances. Hence, it is crucial that fiscal adjustment should not be to the detriment of investment, especially investment that supports the common priorities of the Union. To this end, the level and quality of public investment should also be effectively monitored. In addition, the ECB agrees that there is an urgent need to foster growth-friendly reforms. For that reason, national ownership of Member States’ national plans is essential. The ECB emphasises that the technical dialogue between the Member State and the Commission under the proposed new SGP preventive arm Regulation, (19) which is an important element of national ownership, should be conducted in a smooth, transparent, and predictable manner. The technical dialogue should be properly structured and detailed to help clearly specify the content of national plans. Hence, the ECB recommends that the proposed new SGP preventive arm Regulation includes a higher level of detail on the requirements for the reforms and investment commitments to be included in all national plans (20).

2.2.   Adjustment period

The proposed new SGP preventive arm Regulation provides that the Member States’ national plans must present a net expenditure trajectory covering a period of at least four years (21). Where a Member State commits to a relevant set of reforms and investments, the adjustment period may be extended by up to three years (22). Such a time horizon is long and stretches beyond a typical electoral cycle and might therefore hinder compliance with those commitments. Therefore, the ECB supports a prudent use of the extensions of national plans and stresses the need for commitments for additional reforms and investments to fully materialise. Moreover, the ECB has two suggestions in respect of the adjustment period and its extension. First, the ECB welcomes the requirement that each of the reform and investment commitments underpinning an extension of the adjustment period must be sufficiently detailed, front-loaded, time-bound and verifiable (23). To ensure that the methodology is sufficiently clear and transparent, the ECB suggests that the assessment framework for assessing Member States’ commitments (24) is developed further. In particular, it should be ensured that such commitments are conducive to enhancing potential growth and, therefore, debt sustainability. Moreover, the ECB recommends that further safeguards be included to ensure an increase in investment for critical policy priorities such as the green and digital transitions, and that reform and investment commitments are sufficiently frontloaded, similarly to the safeguards already in place for fiscal adjustment (25). Second, until 2026 the reform and investment commitments included in the approved recovery and resilience plans of the Member States can be taken into account for an extension of the adjustment period (26) . While welcoming consideration of the recovery and resilience plans, the ECB recommends that the assessment framework ensures that a substantial share of the reforms and investments put forward by the Member States are in addition to pre-existing commitments.

2.3.   Revised national plans

The proposed new SGP preventive arm Regulation sets out the possibility for Member States to submit a revised national plan if there are objective circumstances preventing the implementation of the original plan, or if the submission of a new national plan is requested by a new government (27). The ECB recommends that the proposed new SGP preventive arm Regulation specifies the objective circumstances that would be considered relevant and clarifies how the Commission considers the past adjustment of the Member State concerned, or the lack thereof, in preparing its new technical trajectory. In addition, the ECB recommends that the proposed new SGP preventive arm Regulation ensures that the revised plan does not permit the backloading of reforms and investments.

3.   Interaction with the macroeconomic imbalance procedure

3.1.

The ECB welcomes the holistic monitoring of national structural reform commitments, together with investments and fiscal policies, as part of the national plans, for all national structural policies, specifically those that can facilitate the prevention and correction of macroeconomic imbalances, as monitored under the MIP (28).

3.2.

The ECB welcomes the requirement for national plans to address the Union’s country-specific recommendations, including those related to macroeconomic imbalances identified under the MIP (29). The ECB recommends that the national plans focus on addressing the main risks of macroeconomic imbalances to fiscal sustainability, sustained losses of competitiveness, and large external imbalances.

3.3.

The proposed new SGP preventive arm Regulation provides that where a Member State fails to implement the reform and investment commitments included in its national plan to address country-specific recommendations relevant to the MIP, and the Member State concerned is affected by excessive imbalances, an excessive imbalance procedure (EIP) can be opened, in accordance with Article 7(2) of Regulation (EU) No 1176/2011 of the European Parliament and of the Council (30) (31). In that case, the Member State must submit a revised national plan, which also serves as the corrective action plan required under Article 8(1) of Regulation (EU) No 1176/2011. The ECB has two comments in this regard. First, given the evolving nature of macroeconomic challenges, the ECB considers that it would be helpful if the framework could also facilitate adjustments to the national plans irrespective of whether or not an EIP is opened. This ensures that relevant reforms and investments can be adjusted to address all newly emerging macroeconomic imbalances and macroeconomic challenges more extensively in a timely and effective manner. Second, the ECB notes that enforcement in respect of macroeconomic imbalances has been a key concern under the existing economic governance framework. The ECB emphasises that the procedures for the prevention and correction of macroeconomic imbalances should be determined by transparent and effective trigger mechanisms, including detailed communication of the procedural decisions (32). To ensure that Member States address macroeconomic imbalances in a timely and effective manner, and as noted by the Council (33), the ECB highlights that the MIP should be used to its full potential and in a transparent and consistent way, ensuring Member States’ ownership of the procedure, including the activation of the EIP where applicable.

4.   Compliance and enforcement

4.1.   Satisfactory compliance by Member States with the commitments underpinning an extension of an adjustment period

The proposed new SGP preventive arm Regulation provides that where a Member State has been granted an extension of the applicable adjustment period but fails to satisfactorily comply with its set of reform and investment commitments underpinning the extension, the Council may, acting upon a recommendation from the Commission, recommend a revised net expenditure path with a shorter adjustment period (34). In that context, the ECB emphasises the need to ensure timely, adequate and transparent monitoring and enforcement of Member States’ compliance with their reform and investment commitments to ensure fiscal and macroeconomic stability. Thus, it may be preferable that, in this case, the proposed new SGP preventive arm Regulation obliges the Council to act upon a recommendation from the Commission, in accordance with the ‘comply-or-explain’ principle (35), to recommend a revised net expenditure path with a shorter adjustment period (36). In this vein, the ECB notes the reference by the Commission to forthcoming work to develop a new enforcement tool (37). The ECB would welcome further details of the new enforcement tool, which do not yet form part of the Commission proposals.

4.2.   Assessment of substantial public debt sustainability challenges and other relevant factors in the context of the Commission’s report under Article 126(3) TFEU

The ECB welcomes the fact that the degree of public debt sustainability challenges of the Member State concerned is included as a key relevant factor for the opening of an excessive deficit procedure (EDP) (38). Given the importance of the assessment of relevant factors for the implementation of the EDP, the ECB calls for a well-defined and transparent methodological approach for the assessment of these factors to be included in the proposed amendments to the SGP corrective arm Regulation.

4.3.   Design of the corrective net expenditure path

The ECB stresses the need for a gradual but swift correction of excessive debt and deficits. In this context it acknowledges that safeguards intended to limit the risk of backloading the fiscal adjustment were introduced in respect of how the corrective net expenditure path must address the debt ratio (39). The ECB welcomes the numerical requirement in relation to deficits, affirming that for the years when the general government deficit is expected to exceed the reference value, the corrective net expenditure path must be consistent with a minimum adjustment. However, it should be clarified how this adjustment is measured. The ECB notes however that the proposed amendments to the SGP corrective arm Regulation (40) would remove the current requirement that the Council recommendation under Article 126(7) TFEU must establish a specific deadline for the correction of the excessive deficit, ‘which shall be completed in the year following its identification unless there are special circumstances’ (41).

4.4.   The control account

The ECB welcomes the requirement for the Commission to set up a control account to keep track of cumulative deviations, both upward and downward, of actual net expenditure from the net expenditure path (42). This is a crucial element to ensure compliance and support the countercyclicality of the rule through the possibility of building fiscal buffers in economic good times which can be used in economic bad times. The information in the control account is taken into account in the context of the Commission’s report under Article 126(3) TFEU (43), and is thus an important factor relevant to the opening of an EDP. For that reason, the ECB recommends that the functioning and key parameters of the control account should be specified further. Moreover, the ECB recommends that the country-specific computations and the status of each Member State under the control account should be published on the Commission’s website, preferably alongside the Commission’s spring and autumn forecasts. Finally, the ECB would recommend the introduction of a threshold for deviations of actual net expenditures from the net expenditure path, which would trigger a requirement for the Commission to prepare a report under Article 126(3) TFEU (44).

5.   The role of independent fiscal institutions and the European Fiscal Board

5.1.

Reinforcing the role of the independent bodies in the fiscal surveillance process can help to reduce the procyclical tendencies inherent in fiscal policymaking while also supporting national ownership, which is essential for sustained implementation of the framework (45). The ECB therefore supports the provisions of the proposals which aim to strengthen the role of independent fiscal institutions (IFIs) (46) by including requirements related to their governance and independence and assigning them tasks (47) that go beyond their existing tasks under Regulation (EU) No 473/2013 of the European Parliament and of the Council (48). Notably, the ECB welcomes the anchoring of the ‘comply-or-explain’ principle in Union legislation. The ECB supports the strengthening of the role of the IFIs, provided that their overall capacity is also improved commensurately with their additional tasks, and that their own adequate and stable resources to carry out their mandate in an effective manner are ensured (49).

5.2.

The ECB recommends that, subject to the abovementioned strengthening of capacity and without prejudice to the role of the Commission under the Treaties, the role of IFIs under the proposed new SGP preventive arm Regulation could be further enhanced by giving them a role in the preparation of Member States’ national plans and the assessment of non-quantifiable targets (for example, on the impact of reforms). IFIs could provide an assessment of the underlying assumptions, the consistency of the national plan with the Commission’s technical trajectory and, where relevant, the plausibility of reform and investment commitments. Likewise, the ECB recommends that the involvement of IFIs under the proposed amendments to the SGP corrective arm Regulation could be further strengthened by requiring the IFI to also prepare an opinion on the Commission’s analysis of relevant factors for the purposes of the report under Article 126(3) TFEU.

5.3.

Finally, the ECB acknowledges the work of the European Fiscal Board (50) and fully supports the Commission’s intention to explore measures to strengthen it. To that end, without prejudice to the competence of the Commission, the ECB supports a significant role of the European Fiscal Board in the economic governance framework of the Union (51). In particular, the ECB welcomes the possibility for the European Fiscal Board to provide an opinion to inform the Council recommendation on activating or extending the general escape clause in accordance with the proposed new SGP preventative arm Regulation (52). As noted above in paragraph 1.1.1 above, the ECB also sees merit in consulting the European Fiscal Board on the methodology underlying the DSA. Furthermore, the role of the European Fiscal Board in assessing the appropriate euro area fiscal stance should also be enhanced.

6.   Commission delegated powers to amend the annexes

6.1.

The proposed new SGP preventive arm Regulation empowers the Commission to adopt delegated acts for the purpose of amending Annexes II to VII, to adapt them in order to take due account of further developments or needs (53).

6.2.

As the Annexes form an integral part of the proposed new SGP preventive arm Regulation, the ECB recommends that the Annexes already include further details and specifications ex ante. In particular, as noted above, further detail could be provided on the information in the national medium-term fiscal-structural plan (Annex II), the control account (Annex IV), the methodology for the assessment of plausibility (Annex V), and the assessment framework for the set of reform and investment commitments underpinning an extension of the adjustment period (Annex VII).

6.3.

Moreover, the ECB wishes to stress the importance of consulting it on all delegated and implementing legal acts that fall in its field of competence, and in a timely manner, pursuant to Article 127(4) first indent, and Article 282(5) TFEU (54).

7.   Relationship with the Treaty on Stability, Coordination and Governance

The ECB welcomes the objective of the Commission proposals to integrate the substance of the Treaty on Stability, Coordination and Governance (TSCG) into the Union legal framework, in accordance with Article 16 thereof (55) . The substance of the TSCG has been interpreted by the Commission to correspond to the Fiscal Compact (Title III of the TSCG). Moreover, the ECB notes that Article 2 of the TSCG ensures that the adoption of the Commission proposals does not necessitate the amendment or repeal of the TSCG. Article 2(1) of the TSCG requires that the TSCG must be applied and interpreted by the contracting parties in conformity with the Treaties on which the European Union is founded, in particular Article 4(3) of the Treaty on European Union and with Union law, including procedural law whenever the adoption of secondary legislation is required. Moreover, Article 2(2) of the TSCG states that the TSCG applies insofar as it is compatible with the Treaties on which the European Union is founded and with Union law, and that it must not encroach upon the competence of the Union to act in the area of the economic union. Thus, the ECB understands that when the Commission proposals are adopted and enter into force, the TSCG will apply and be interpreted in accordance with the new economic governance framework.

8.   Completing Europe’s Economic and Monetary Union

Given the importance of a robust Union framework for economic and fiscal policy coordination in the context of monetary union, the ECB emphasises that further progress on euro-area specific aspects is needed. The development of a framework to monitor and steer the aggregate euro-area fiscal stance is important to provide a counterpart to monetary policy, as it can help ensure that monetary and fiscal policy better complement each other. Moreover, the need for a permanent central fiscal capacity remains. Such a tool, if appropriately designed, could play a role in enhancing macroeconomic stabilisation and convergence in the euro area in the longer run, including through investment, thereby also supporting the single monetary policy. To that end, a permanent central fiscal capacity would need to be sufficient in size and have permanent funding (56) .

---

(1)  COM (2023) 240 final.

(2)  COM (2023) 241 final.

(3)  COM (2023) 242 final.

(4)  See paragraph 1.1 of Opinion CON/2018/25 of the European Central Bank of 11 May 2018 on a proposal for a Council Directive laying down provisions for strengthening fiscal responsibility and the medium-term budgetary orientation in the Member States (OJ C 261, 25.7.2018, p. 1). All ECB opinions are available on EUR-Lex.

(5)  See Eurosystem reply to the Communication from the European Commission ‘The EU economy after COVID-19: implications for economic governance’, 1 December 2021, available on the ECB’s website at www.ecb.europa.eu

(6)  See European Commission, ‘Fiscal policy guidance for 2024: Promoting debt sustainability and sustainable and inclusive growth’, 8 March 2023.

(7)  Regulation (EU) No 1176/2011 of the European Parliament and of the Council of 16 November 2011 on the prevention and correction of macroeconomic imbalances (OJ L 306, 23.11.2011, p. 25).

(8)  Paris Agreement adopted under the United Nations Framework Convention on Climate Change (OJ L 282, 19.10.2016, p. 4). Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’) (OJ L 243, 9.7.2021, p. 1).

(9)  See ‘Completing Europe's Economic and Monetary Union’, Report by Jean-Claude Juncker, in close cooperation with Donald Tusk, Jeroen Dijsselbloem, Mario Draghi and Martin Schulz, 22 June 2015, p. 4, available on the Commission's website at www.ec.europa.eu. See also General Observations of Opinion CON/2018/51, of the European Central Bank of 9 November 2018 on a proposal for a Regulation on the establishment of a European Investment Stabilisation Function (OJ C 444, 10.12.2018, p. 11); paragraph 1.3 of Opinion CON/2019/37 of the European Central Bank of 30 October 2019 on a proposal for a Regulation on a governance framework for the budgetary instrument for convergence and competitiveness for the euro area (OJ C 408, 4.12.2019, p. 3).

(10)  See Articles 5 and 6 and Annex I of the proposed new SGP preventive arm Regulation. See also, Communication from the Commission to the European Parliament, the Council, the European Central Bank, the European Economic and Social Committee of the Regions, ‘Communication on orientations for a reform of the EU economic governance framework’, COM (2022) 583 final, 9 November 2022.

(11)  For instance, in Article 2, point (2), and/or in Annex II, point (a), of the proposed new SGP preventive arm Regulation.

(12)  See Article 6, point (a), of the proposed new SGP preventive arm Regulation.

(13)  See Article 8 and Annex V of the proposed new SGP preventive arm Regulation.

(14)  In particular, this could be included in Annex V of the proposed new SGP preventive arm Regulation.

(15)  See Article 5 of the proposed new SGP preventive arm Regulation.

(16)  See Article 11(2) of the proposed new SGP preventive arm Regulation.

(17)  See also Article 1, point (1), of the proposed amendments to the SGP corrective arm Regulation, which amends Article 2(1a) of Council Regulation (EC) No 1467/97 of 7 July 1997 on speeding up and clarifying the implementation of the excessive deficit procedure (OJ L 209, 2.8.1997, p. 6).

(18)  See Article 6, points (c) and (d), Article 15(2) and Annex I, point (c), of the proposed new SGP preventive arm Regulation. See Article 1, point (2), of the proposed amendments to the SGP corrective arm Regulation, which amends Articles 3 (4) of Council Regulation (EC) No 1467/97; see Article 1, point (4), of the proposed amendments to the SGP corrective arm Regulation, which amends Article 5(1) of Council Regulation (EC) 1467/97.

(19)  See Article 10 of the proposed new SGP preventive arm Regulation

(20)  See Articles 11, 12 and 14 and Annex II of the proposed new SGP preventive arm Regulation.

(21)  See Article 5 and Article 11(1) of the proposed new SGP preventive arm Regulation.

(22)  See Article 13(1) of the SGP preventive arm Regulation.

(23)  See Article 13(3) of the proposed new SGP preventive arm Regulation.

(24)  See Article 13(5) and Annex VII of the proposed new SGP preventive arm Regulation.

(25)  See Article 6, points (c) and (d), and Article 15(2) of the proposed new SGP preventive arm Regulation.

(26)  See Article 13(4) of the proposed new SGP preventive arm Regulation.

(27)  See Article 14(1) of the proposed new SGP preventive arm Regulation.

(28)  See Article 11(1), Article 12, point (b), Article 13(2) and Articles 16 and 30 of the proposed new SGP preventive arm Regulation.

(29)  See Article 11(1) and Article 12, point (b), of the proposed new SGP preventive arm Regulation.

(30)  Regulation (EU) No 1176/2011 of the European Parliament and of the Council of 16 November 2011 on the prevention and correction of macroeconomic imbalances (OJ L 306, 23.11.2011, p. 25).

(31)  See Article 30 of the proposed new SGP preventive arm Regulation.

(32)  See paragraph 18 of Opinion CON/2011/13 of the European Central Bank of 16 February 2011 on economic governance reform in the European Union (OJ C 150, 20.5.2011, p. 1).

(33)  See the Council’s press release of 12 July 2022, ‘Macroeconomic imbalance procedure: Council adopts conclusions’, available on the Council’s website at www.consilium.europa.eu

(34)  See Article 19 of the proposed new SGP preventive arm Regulation.

(35)  See Article 27 of the proposed new SGP preventive arm Regulation.

(36)  See Article 19 of the proposed new SGP preventive arm Regulation. The drafting could be amended to state: ‘[…] the Council shall on a recommendation from the Commission, recommend a revised net expenditure path with a shorter adjustment period’.

(37)  See Communication from the Commission to the European Parliament, the Council, the European Central Bank, the European Economic and Social Committee and the Committee of the Regions ‘Communication on orientations for a reform of the EU economic governance framework’, COM (2022) 583 final, 9 November 2022

(38)  Article 1, point (1), of the proposed amendments to the SGP corrective arm Regulation, which amends Article 2(3) of Council Regulation (EC) No 1467/97.

(39)  See Article 1, point (2), of the proposed amendments to the SGP corrective arm Regulation, which amends Article 3(4) of Council Regulation (EC) No 1467/97; see Article 1, point (4), of the proposed amendments to the SGP corrective arm Regulation, which amends Article 5(1) of Council Regulation (EC) 1467/97.

(40)  See Article 1, point (2), of the proposed amendments to the SGP corrective arm Regulation, which amends Article 3(4) of Council Regulation (EC) No 1467/97

(41)  See Article 3(4) of Council Regulation (EC) No 1467/97.

(42)  See Article 21, second paragraph, and Annex IV of the proposed new SGP preventive arm Regulation.

(43)  See Article 1, point (1), of the proposed amendments to the SGP corrective arm Regulation, which amends Article 2(3), point (b), of Council Regulation (EC) No 1467/97.

(44)  For instance, under Article 1, point (1), of the proposed amendments to the SGP corrective arm Regulation, which amends Article 2 of Council Regulation (EC) 1467/97.

(45)  See Eurosystem reply to the Communication from the European Commission ‘The EU economy after COVID-19: implications for economic governance’ of 19 October 2021, 1 December 2021.

(46)  See paragraph 2.4.1 of Opinion CON/2018/25.

(47)  See Article 1, point (8), of the proposed amendments to the budgetary frameworks Directive, which amends Article 8 of Council Directive 2011/85/EU of 8 November 2011 on requirements for budgetary frameworks of the Member States (OJ L 306, 23.11.2011, p. 41). See Article 22 of the proposed new SGP preventive arm Regulation. See Article 1, point (1), of the proposed amendments to the SGP corrective arm Regulation, which amends Article 2(3) of Council Regulation (EC) No 1467/97, and Article 1, point (3), of the proposed amendments to the SGP corrective arm Regulation, which amends Article 3(5) of Council Regulation (EC) No 1467/97.

(48)  Regulation (EU) No 473/2013 of the European Parliament and of the Council of 21 May 2013 on common provisions for monitoring and assessing draft budgetary plans and ensuring the correction of excessive deficit of the Member States in the euro area (OJ L 140, 27.5.2013, p. 11)

(49)  See Article 1, point (8), of the proposed amendments to the budgetary frameworks Directive, which amends Article 8(3), point (c), of Council Directive 2011/85/EU.

(50)  Commission Decision (EU) 2015/1937 of 21 October 2015 establishing an independent advisory European Fiscal Board (OJ L 282, 28.10.2015, p. 37).

(51)  See paragraph 22 of Opinion CON/2011/13.

(52)  See Article 24 of the proposed new SGP preventive arm Regulation.

(53)  See Article 32 of the proposed new SGP preventive arm Regulation.

(54)  See Opinion CON/2011/42 of the European Central Bank of 4 May 2011 on a proposal for a Directive of the European Parliament and of the Council amending Directives 2003/71/EC and 2009/138/EC in respect of the powers of the European Insurance and Occupational Pensions Authority and the European Securities and Markets Authority; see paragraph 8 of Opinion CON/2011/44 of the European Central Bank of 19 May 2011 on the proposal for a Regulation of the European Parliament and of the Council on the European system of national and regional accounts in the European Union; see paragraph 4 of Opinion CON/2012/5 of the European Central Bank of 25 January 2012 on a proposal for a Directive on the access to the activity of credit institutions and the prudential supervision of credit institutions and investment firms and a proposal for a Regulation on prudential requirements for credit institutions and investment firms; see paragraph 1.9 of Opinion CON/2018/1 of the European Central Bank of 2 January 2018 on a proposal for a Regulation of the European Parliament and of the Council on European business statistics amending Regulation (EC) No 184/2005 and repealing 10 legal acts in the field of business statistics.

(55)  See paragraph 1.2 of Opinion CON/2018/25. Article 16 of the TSCG envisages that within five years, at most, of the date of entry into force of the TSCG, i.e. by 1 January 2018, the necessary steps shall be taken with the aim of incorporating the substance of the TSCG into the Union legal framework.

(56)  See Eurosystem reply to the Communication from the European Commission ‘The EU economy after COVID-19: implications for economic governance’ of 19 October 2021, 1 December 2021. See also General Observations of Opinion CON/2018/51 and paragraph 1.3 of Opinion CON/2019/37.

Euro exchange rates (1)

17 August 2023

(2023/C 290/04)

1 euro =

	Currency	Exchange rate
USD	US dollar	1,0900
JPY	Japanese yen	158,88
DKK	Danish krone	7,4518
GBP	Pound sterling	0,85395
SEK	Swedish krona	11,8666
CHF	Swiss franc	0,9555
ISK	Iceland króna	144,10
NOK	Norwegian krone	11,4985
BGN	Bulgarian lev	1,9558
CZK	Czech koruna	24,078
HUF	Hungarian forint	384,73
PLN	Polish zloty	4,4718
RON	Romanian leu	4,9385
TRY	Turkish lira	29,5376
AUD	Australian dollar	1,6931
CAD	Canadian dollar	1,4718
HKD	Hong Kong dollar	8,5318
NZD	New Zealand dollar	1,8298
SGD	Singapore dollar	1,4793
KRW	South Korean won	1 458,28
ZAR	South African rand	20,7417
CNY	Chinese yuan renminbi	7,9387
IDR	Indonesian rupiah	16 726,82
MYR	Malaysian ringgit	5,0712
PHP	Philippine peso	61,738
RUB	Russian rouble
THB	Thai baht	38,542
BRL	Brazilian real	5,4127
MXN	Mexican peso	18,6156
INR	Indian rupee	90,4995

---

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

Update of the list of border crossing points as referred to in Article 2(8) of Regulation (EU) 2016/399 of the European Parliament and of the Council on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (1)

(2023/C 290/05)

The publication of the list of border crossing points as referred to in Article 2(8) of Regulation (EU) 2016/399 of the European Parliament and of the Council of 9 March 2016 on a Union Code on the rules governing the movement of persons across borders (Schengen Borders Code) (2) is based on the information notified by the Member States to the Commission pursuant to Article 39 of the Schengen Borders Code.

In addition to the publication in the Official Journal, a regular update is available on the website of the Directorate-General for Migration and Home Affairs.

LIST OF BORDER CROSSING POINTS

GERMANY

Replacement of the information published in OJ C 202, 9.6.2023, p. 33.

Ports on the North Sea

(1)

Borkum

(2)

Brake

(3)	Brunsbüttel

(4)

Büsum

(5)	Bützflether Sand

(6)

Bremen

(7)	Bremerhaven

(8)

Cuxhaven

(9)	Eckwarderhörne

(10)

Elsfleth

(11)

Emden

(12)	Fedderwardersiel

(13)	Glückstadt

(14)

Hamburg

(15)	Hamburg-Neuenfelde

(16)

Helgoland

(17)

Husum

(18)

Leer

(19)

Lemwerder

(20)

List/Sylt

(21)

Norddeich

(22)

Nordenham

(23)

Norderney

(24)

Papenburg

(25)	Stadersand

(26)	Wangerooge

(27)

Wedel

(28)	Wewelsfleth

(29)	Wilhelmshaven

Baltic ports

(1)	Eckernförde (Federal German Navy port facilities)

(2)	Port of Flensburg

(3)	Port of Greifswald-Ladebow

(4)	Jägersberg (Federal German Navy port facilities)

(5)

Kiel

(6)	Kiel (Federal German Navy port facilities)

(7)	Kiel-Holtenau

(8)

Lubmin

(9)

Lübeck

(10)	Lübeck-Travemünde

(11)

Mukran

(12)

Neustadt

(13)	Puttgarden

(14)

Rendsburg

(15)	Port of Rostock (amalgamation of the overseas ports of Warnemünde and Rostock)

(16)

Sassnitz

(17)

Stralsund

(18)	Surendorf (Federal German Navy port facilities)

(19)

Vierow

(20)

Wismar

(21)

Wolgast

ODERHAFF

(1)	Ueckermünde

Airports, aerodromes, air fields

IN THE FEDERAL STATE OF BADEN WÜRTTEMBERG

(1)	Aalen-Heidenheim-Elchingen

(2)	Baden Airport Karlsruhe Baden-Baden

(3)	Donaueschingen-Villingen

(4)	Freiburg/Brg.

(5)	Friedrichshafen-Löwental

(6)	Heubach (District of Schwäb. Gmünd)

(7)

Lahr

(8)

Laupheim

(9)	Leutkirch-Unterzeil

(10)	Mannheim-City

(11)

Mengen

(12)	Niederstetten

(13)	Schwäbisch Hall

(14)

Stuttgart

IN THE FEDERAL STATE OF BAVARIA

(1)	Aschaffenburg

(2)	Augsburg-Mühlhausen

(3)	Bayreuth – Bindlacher Berg

(4)	Coburg-Brandebsteinsebene

(5)	Giebelstadt

(6)	Hof-Plauen

(7)	Ingolstadt

(8)

Lechfeld

(9)	Memmingerberg

(10)	München ‘Franz Joseph Strauß’

(11)

Neuburg

(12)

Nürnberg

(13)	Oberpfaffenhofen

(14)

Roth

(15)	Straubing-Wallmühle

IN THE FEDERAL STATE OF BERLIN

(1)	Berlin-Tegel

IN THE FEDERAL STATE OF BRANDENBURG

(1)	Berlin Brandenburg ‘Willy Brandt’

(2)	Schönhagen

IN THE FEDERAL STATE OF BREMEN

(1)

Bremen

IN THE FEDERAL STATE OF HAMBURG

(1)

Hamburg

IN THE FEDERAL STATE OF HESSE

(1)	Allendorf/Eder

(2)

Egelsbach

(3)	Frankfurt/Main

(4)

Fritzlar

(5)	Kassel-Calden

(6)	Reichelsheim

IN THE FEDERAL STATE OF MECKLENBURG-WESTERN POMERANIA

(1)	Neubrandenburg-Trollenhagen

(2)	Rostock-Laage

IN THE FEDERAL STATE OF LOWER SAXONY

(1)	Braunschweig-Waggum

(2)	Bückeburg-Achum

(3)

Celle

(4)	Damme/Dümmer-See

(5)

Diepholz

(6)

Emden

(7)

Fassberg

(8)

Hannover

(9)	Leer-Nüttermoor

(10)

Nordholz

(11)	Osnabrück-Atterheide

(12)	Wilhelmshaven-Mariensiel

(13)	Wittmundhafen

(14)

Wunstorf

IN THE FEDERAL STATE OF NORTH RHINE-WESTPHALIA

(1)	Aachen-Merzbrück

(2)

Arnsberg

(3)	Bielefeld-Windelsbleiche

(4)	Bonn-Hardthöhe

(5)	Dortmund-Wickede

(6)	Düsseldorf

(7)	Essen-Mülheim

(8)	Bonn Hangelar

(9)

Köln/Bonn

(10)	Marl/Loemühle

(11)	Mönchengladbach

(12)	Münster-Osnabrück

(13)

Nörvenich

(14)	Paderborn-Lippstadt

(15)	Porta Westfalica

(16)	Rheine-Bentlage

(17)	Siegerland

(18)	Stadtlohn-Wenningfeld

(19)	Weeze-Lahrbruch

IN THE FEDERAL STATE OF RHINELAND-PALATINATE

(1)

Büchel

(2)

Föhren

(3)

Hahn

(4)	Koblenz-Winningen

(5)	Mainz-Finthen

(6)	Pirmasens-Pottschütthöhe

(7)	Ramstein (US Air Base)

(8)

Speyer

(9)	Spangdahlem (US Air Base)

(10)	Zweibrücken

IN THE FEDERAL STATE OF SAARLAND

(1)	Saarbrücken-Ensheim

(2)	Saarlouis/Düren

IN THE FEDERAL STATE OF SAXONY

(1)

Dresden

(2)	Leipzig-Halle

(3)	Rothenburg/Oberlausitz

IN THE FEDERAL STATE OF SAXONY-ANHALT

(1)

Cochstedt

(2)

Magdeburg

IN THE FEDERAL STATE OF SCHLESWIG-HOLSTEIN

(1)	Helgoland-Düne

(2)

Hohn

(3)	Kiel-Holtenau

(4)	Lübeck-Blankensee

(5)	Schleswig/Jagel

(6)	Westerland/Sylt

IN THE FEDERAL STATE OF THURINGIA

(1)	Altenburg-Nobitz

(2)	Erfurt-Weimar

GREECE

Replacement of the information published in OJ C 261, 25.7.2018, p. 6.

Εναέρια σύνορα  (*1)		Airports (Air Borders)
1.	Αθήνα	Αthina
2.	Ηράκλειο	Heraklion
3.	Θεσσαλονίκη	Thessaloniki
4.	Ρόδος	Rodos (Rhodes)
5.	Κέρκυρα	Kerkira (Corfou)
6.	Αντιμάχεια Κω	Antimachia (Kos)
7.	Χανιά	Chania
8.	Πυθαγόρειο Σάμου	Pithagorio, Samos
9.	Μυτιλήνη	Mitilini
10.	Ιωάννινα	Ioannina
11.	Άραξος	Araxos
12.	Σητεία	Sitia
13.	Χίος	Chios (*1)
14.	Αργοστόλι	Argostoli
15.	Καλαμάτα	Kalamata
16.	Καβάλα	Kavala
17.	Άκτιο Βόνιτσας	Aktio Vonitsas
18.	Ζάκυνθος	Zakinthos
19.	Θήρα	Thira
20.	Σκιάθος	Skiathos
21.	Κάρπαθος	Karpathos (*1)
22.	Μύκονος	Mikonos
23.	Αλεξανδρούπολη	Alexandroupoli
24.	Ελευσίνα	Elefsina
25.	Ανδραβίδα	Andravida
26.	Ατσική Λήμνου	Atsiki – Limnos
27	Νέα Αγχίαλος	Νea Aghialos
28.	Αργος Ορεστικού (Καστοριά)	Argos

Θαλάσσια σύνορα		Ports (Sea Borders)
1.	Γύθειο	Githio
2.	Σύρος	Siros
3.	Ηγουμενίτσα	Igoymenitsa
4.	Στυλίδα	Stilida
5.	Άγιος Νικόλαος	Agios Nikolaos
6.	Ρέθυμνο	Rethimno
7.	Λευκάδα	Lefkada
8.	Σάμος	Samos
9.	Βόλος	Volos
10.	Κως	Kos
11.	Δάφνη Αγίου Όρους	Dafni, Agiou Oros
12.	Ίβηρα Αγίου Όρους	Ivira, Agiou Oros
13.	Γλυφάδα	Glifada
14.	Πρέβεζα	Preveza
15.	Πάτρα	Patra
16.	Κέρκυρα	Kerkira
17.	Σητεία	Sitia
18.	Χίος	Chios
19.	Αργοστόλι	Argostoli
20.	Θεσσαλονίκη	Thessaloniki
21.	Κόρινθος	Korinthos
22.	Καλαμάτα	Kalamata
23.	Κάλυμνος	Kalymnos (*2)
24.	Καβάλα	Kavala
25.	Ιθάκη	Ithaki
26.	Πύλος	Pilos
27.	Πυθαγόρειο Σάμου	Pithagorio - Samos
28.	Λαύριο	Lavrio
29.	Ηράκλειο	Heraklio
30.	Σάμη Κεφαλληνίας	Sami, Kefalonia
31.	Πειραιάς	Pireas
32.	Μήλος	Milos
33.	Κατάκολο	Katakolo
34.	Σούδα Χανίων	Souda - Chania
35.	Ιτέα	Itea
36.	Ελευσίνα	Elefsina
37.	Μύκονος	Mikonos
38.	Ναύπλιο	Nafplio
39.	Χαλκίδα	Chalkida
40.	Ρόδος	Rodos
41.	Ζάκυνθος	Zakinthos
42.	Θήρα	Thira
43.	Καλοί Λιμένες Ηρακλείου	Kali - Limenes - Herakliou
44.	Μύρινα Λήμνου	Myrina - Limnos
45.	Παξοί	Paxi
46.	Σκιάθος	Skiathos
47.	Αλεξανδρούπολη	Alexandroupoli
48.	Αίγιο	Aighio
49.	Πάτμος	Patmos
50.	Σύμη	Simi
51.	Μυτιλήνη	Mitilini
52.	Χανιά	Chania
53.	Αστακός	Astakos
54.	Καρλόβασι Σάμου	Karlovasi Samos (*2)
55.	Πέτρα Λέσβου	Petra, Lesvos (*2)
56.	Αγία Μαρίνα Λέρου	Agia Marina Leros (*2)
57.	Νέα Μουδανιά Χαλκιδικής	Nea Moudania
58.	Άγιοι Θεόδωροι	Agioi Theodoroi
59.	Καστελόριζο	Kastellorizo
60.	Πλωμάρι Λέσβου	Plomari, Lesvos (*2)

Χερσαία σύνορα		Land borders
Με την Αλβανία		With Albania
1.	Κακαβιά	1.	Kakavia
2.	Κρυσταλλοπηγή	2	Kristalopigi
3	Σαγιάδα	3	Sagiada
4	Μερτζάνη	4	Mertzani
Με την πρώην Γιουγκοσλαβική Δημοκρατία της Μακεδονίας		With the former Yugoslav Republic of Macedonia
1.	Νίκη	1.	Niki
2.	Ειδομένη (σιδηροδρομικό)	2.	Idomeni (Rail)
3.	Εύζωνοι	3.	Evzoni
4.	Δοϊράνη	4.	Doirani
Με τη Βουλγαρία		With Bulgaria
1.	Προμαχώνας	1.	Promachonas
2.	Προμαχώνας (σιδηροδρομικό)	2.	Promachonas (Rail)
3.	Δίκαια (σιδηροδρομικό)	3.	Dikea, Evros (Rail)
4.	Ορμένιο	4.	Ormenio, Evros
5.	Εξοχή	5	Εχοηι
6.	Άγιος Κωνσταντίνος Ξάνθης	6	Agios Konstantinos (Xanthi)
7.	Κυπρίνος Έβρου	7	Kyprinos (Evros)
8.	Νυμφαία	8	Nymfaia
Με την Τουρκία		With Turkey
1.	Καστανιές Έβρου	1.	Kastanies
2.	Πύθιο (σιδηροδρομικό)	2.	Pithio (Rail)
3.	Κήποι Έβρου	3.	Kipi

FRANCE

Replacement of the information published in OJ C 202, 9.6.2023, p. 33.

Air borders

(1)	Ajaccio-Napoléon-Bonaparte

(2)	Albert-Bray

(3)	Angers-Marcé

(4)	Angoulême-Brie-Champniers

(5)	Annecy-Methet

(6)	Auxerre-Branches

(7)	Avignon-Caumont

(8)	Bâle-Mulhouse

(9)	Bastia-Poretta

(10)	Beauvais-Tillé

(11)	Bergerac-Dordonge-Périgord

(12)	Béziers-Vias

(13)	Biarritz-Pays Basque

(14)	Bordeaux-Mérignac

(15)	Brest-Bretagne

(16)	Brive-Souillac

(17)	Caen-Carpiquet

(18)	Calais-Dunkerque

(19)	Calvi-Sainte-Catherine

(20)	Cannes-Mandelieu

(21)	Carcassonne-Salvaza

(22)	Châlons-Vatry

(23)	Chambéry-Aix-les-Bains

(24)	Châteauroux-Déols

(25)	Cherbourg-Mauperthus

(26)	Clermont-Ferrand-Auvergne

(27)	Colmar-Houssen

(28)	Deauville-Normandie

(29)	Dijon-Longvic

(30)	Dinard-Pleurtuit-Saint-Malo

(31)	Dôle-Tavaux

(32)	Epinal-Mirecourt

(33)	Figari-Sud Corse

(34)	Grenoble-Alpes-Isère

(35)	Hyères-le Palivestre

(36)	Istres-Le-Tubé

(37)	La Môle-Saint-Tropez (annual opening from 1 July to 15 October)

(38)	La Rochelle-Ile de Ré

(39)	La Roche-sur-Yon

(40)	Laval-Entrammes

(41)	Le Castellet (Annual opening from 1 June to 31 July. Opening exceptional from 22 to 31 October 2022.)

(42)	Le Havre-Octeville

(43)	Le Mans-Arnage

(44)	Le Touquet-Côte ďOpale

(45)	Lille-Lesquin

(46)	Limoges-Bellegarde

(47)	Lorient-Lann-Bihoué

(48)

Lyon-Bron

(49)	Lyon-Saint-Exupéry

(50)	Marseille-Provence

(51)	Metz-Nancy-Lorraine

(52)	Monaco-Héliport

(53)	Montpellier-Méditérranée

(54)	Nantes-Atlantique

(55)	Nice-Côte d’Azur

(56)	Nîmes-Garons

(57)	Orléans-Bricy

(58)	Orléans-Saint-Denis-de-l’Hôtel

(59)	Paris-Charles de Gaulle

(60)	Paris-Issy-les-Moulineaux

(61)	Paris-le Bourget

(62)	Paris-Orly

(63)	Pau-Pyrénées

(64)	Perpignan-Rivesaltes

(65)	Poitiers-Biard

(66)	Pontoise / Cormeille-en-Vexin (14-22 June 2023, 13:30-16:30; 23-25 June 2023, 12:30-17:30)

(67)	Quimper-Pluguffan (open from the beginning of May to the beginning of September)

(68)	Rennes Saint-Jacques

(69)	Rodez-Aveyron

(70)	Rouen-Vallée de Seine

(71)	Saint-Brieuc-Armor

(72)	Saint-Etienne Loire

(73)	Saint-Nazaire-Montoir

(74)	Salon de Provence (10 May 2023–27 May 2023)

(75)	Strasbourg-Entzheim

(76)	Tarbes-Lourdes-Pyrénées

(77)	Toulouse-Blagnac

(78)	Toulouse-Francazal

(79)	Tours-Val de Loire

(80)	Troyes-Barberey

(81)	Valence – Chabeuil (as of 1 June 2021)

(82)	Vélizy-Villacoublay

Sea borders

(1)

Ajaccio

(2)

Bastia

(3)

Bayonne

(4)

Bordeaux

(5)

Boulogne

(6)

Brest

(7)	Caen-Ouistreham

(8)

Calais

(9)	Cannes-Vieux Port

(10)

Carteret

(11)

Cherbourg

(12)

Dieppe

(13)

Douvres

(14)

Dunkerque

(15)

Granville

(16)

Honfleur

(17)	La Rochelle-La Pallice

(18)

Le Havre

(19)	Les Sables-d’Olonne-Port

(20)

Lorient

(21)

Marseille

(22)	Monaco-Port de la Condamine

(23)	Nantes-Saint-Nazaire

(24)

Nice

(25)	Port-de-Bouc-Fos/Port-Saint-Louis

(26)	Port-la-Nouvelle

(27)	Port-Vendres

(28)

Roscoff

(29)

Rouen

(30)	Saint-Brieuc

(31)	Saint-Malo

(32)

Sète

(33)

Toulon

Land borders

(1)	Bourg Saint Maurice railway station (open from the beginning of December to mid-April)

(2)	Moûtiers railway station (open from the beginning of December to mid-April)

(3)	Ashford International railway station

(4)	Cheriton/Coquelles

(5)	Chessy-Marne-la-Vallée railway station

(6)	Fréthun railway station

(7)	Lille-Europe railway station

(8)	Paris-Nord railway station

(9)	St-Pancras railway station

(10)	Ebbsfleet railway station

(11)	Pas de la Case-Porta

(12)	Roissy TGV railway station - airport

POLAND

Replacement of the information published in OJ C 84, 4.3.2016, p. 2.

Border crossing points:

1)

accessible to all: No Name Type Authorised type of border traffic Opening times a) national border with the Russian Federation: 1 Braniewo - Mamonovo rail traffic passenger traffic, freight traffic 24/7 2 Bezledy - Bagrationovsk road traffic passenger traffic, freight traffic, vehicles with an axle load of up to 8 tonnes engaged in international transport 24/7 3 Glomno - Bagrationovsk rail traffic freight traffic 24/7 4 Skandawa - Zheleznodorozhny rail traffic freight traffic 24/7 5 Gołdap - Gusev road traffic freight traffic - vehicles with a maximum permissible laden weight not exceeding 7.5 tonnes 24/7 6 Grzechotki - Mamonovo II road traffic passenger traffic, freight traffic 24/7 7 Gronowo - Mamonovo road traffic passenger traffic, freight traffic, vehicles with a laden weight not exceeding 6 tonnes 24/7 b) national border with Belarus: 1 Rudawka - Lesnaya river traffic passenger traffic from 1.5 to 1.10 between 7:00 and 19:00 2 Kuźnica Białostocka - Grodno rail traffic passenger traffic, freight traffic 24/7 3 Kuźnica Białostocka -Bruzgi road traffic passenger traffic, freight traffic 24/7 4 Bobrowniki - Bierestovica road traffic passenger traffic, freight traffic 24/7 5 Zubki Białostockie - Bierestovica rail traffic freight traffic 24/7 6 Siemianówka - Svislach rail traffic freight traffic 24/7 7 Białowieża - Piererov road traffic passenger traffic: pedestrians, cyclists from 1.4 to 30.9, between 8:00 and 20:00; from 1.10 to 31.3, between 8:00 and 18:00 8 Czeremcha - Vysoko-Litovsk rail traffic freight traffic 24/7 9 Kukuryki - Kozłowiczy road traffic freight traffic 24/7 10 Terespol - Brest rail traffic passenger traffic, freight traffic 24/7 11 Terespol - Brest road traffic passenger traffic 24/7 12 Sławatycze - Damachava road traffic passenger traffic — excluding buses 24/7 c) national border with Ukraine: 1 Dorohusk - Jagodzin road traffic passenger traffic, freight traffic 24/7 2 Dorohusk - Jagodzin rail traffic passenger traffic, freight traffic 24/7 3 Zosin - Ustilug road traffic passenger traffic 24/7 4 Hrubieszów — Volodymyr-Volynsky rail traffic passenger traffic, freight traffic 24/7 5 Dołhobyczów - Uhryniv road traffic passenger vehicles with a permissible laden weight not exceeding 3.5 tonnes and buses 24/7 6 Hrebenne - Rava-Rus’ka road traffic passenger traffic, freight traffic 24/7 7 Hrebenne - Rava-Rus’ka rail traffic passenger traffic 24/7 8 Werchrata - Rava-Rus’ka rail traffic freight traffic 24/7 9 Budomierz - Hrushiv road traffic passenger traffic, freight traffic, vehicles with a maximum permissible laden weight not exceeding 3.5 tonnes 24/7 10 Korczowa - Krakovets’ road traffic passenger traffic, freight traffic 24/7 11 Przemyśl - Mostys’ka rail traffic passenger traffic, freight traffic 24/7 12 Medyka - Shehyni road traffic passenger traffic, freight traffic 24/7 13 Krościenko - Smil’nytsya road traffic passenger traffic, freight traffic, vehicles with a maximum permissible laden weight not exceeding 7.5 tonnes 24/7 14 Krościenko - Khyriv rail traffic passenger traffic 24/7 d) maritime border: 1 Szczecin sea traffic passenger traffic, freight traffic 24/7 2 Trzebież sea traffic passenger traffic 24/7 3 Nowe Warpno sea traffic passenger traffic 24/7 4 Świnoujście sea traffic passenger traffic, freight traffic 24/7 5 Dziwnów sea traffic passenger traffic in recreational craft, freight traffic (Polish fisheries) 24/7 6 Mrzeżyno sea traffic freight traffic (Polish fisheries) 24/7 7 Kołobrzeg sea traffic passenger traffic, freight traffic 24/7 8 Darłowo sea traffic passenger traffic, freight traffic 24/7 9 Ustka sea traffic passenger traffic, freight traffic 24/7 10 Łeba sea traffic passenger traffic in recreational craft, freight traffic (Polish fisheries) 24/7 11 Władysławowo sea traffic passenger traffic, freight traffic 24/7 12 Jastarnia sea traffic passenger traffic in recreational craft, freight traffic (Polish fisheries) 24/7 13 Hel sea traffic passenger traffic, freight traffic 24/7 14 Gdynia sea traffic passenger traffic, freight traffic 24/7 15 Gdańsk-Port sea traffic passenger traffic, freight traffic 24/7 16 Gdańsk-Górki Zachodnie sea traffic passenger traffic in recreational craft, Polish fisheries 24/7 17 Elbląg sea traffic passenger traffic, freight traffic 24/7 18 Frombork sea traffic passenger traffic, freight traffic 24/7 19 Nowy Świat sea traffic passenger traffic, freight traffic 24/7 e) permanent airport: 1 Poznań-Ławica air traffic passenger traffic, freight traffic 24/7 2 Bydgoszcz air traffic passenger traffic, freight traffic 24/7 3 Łódż-Lublinek air traffic passenger traffic, freight traffic 24/7 4 Świdnik k/Lublina air traffic passenger traffic, freight traffic 24/7 5 Kraków-Balice air traffic passenger traffic, freight traffic 24/7 6 Katowice-Pyrzowice air traffic passenger traffic, freight traffic 24/7 7 Wroclaw-Strachowice air traffic passenger traffic, freight traffic 24/7 8 Gdańsk-Rębiechowo air traffic passenger traffic, freight traffic 24/7 9 Rzeszów-Jasionka air traffic passenger traffic, freight traffic 24/7 10 Warsaw-Okęcie air traffic passenger traffic, freight traffic 24/7 11 Warsaw-Modlin air traffic passenger traffic, freight traffic 24/7 12 Szczecin-Goleniów air traffic passenger traffic, freight traffic 24/7 13 Radom-Sadków air traffic passenger traffic, freight traffic 24/7 14 Mazury air traffic passenger traffic 24/7 15 Zielona Góra-Babimost air traffic passenger traffic, freight traffic 24/7 f) other airport: 1 Jelenia Góra air traffic passenger traffic between 7:00 and 20:00; from 1.5 to 30.9, between 7:00 and 22:00 2 Mielec air traffic passenger traffic between 8:00 and 20:00; from 1.5 to 30.9, between 7:00 and 22:00 3 Zielona Góra–Przylep air traffic passenger traffic between 6:00 and 20:00; from 1.5 to 30.9, between 6:00 and 22:00 4 Gdynia-Kosakowo air traffic passenger traffic between 6:00 and 20:00; from 1.5 to 30.9, between 6:00 and 22:00 5 Kielce-Maslów air traffic passenger traffic, freight traffic between 6:00 and 20:00; from 1.5 to 30.9, between 6:00 and 22:00

2)	international border crossing points for nationals of the states concerned: No Name Type Authorised type of border traffic Opening times 1 Polowce-Pieszczatka road traffic passenger traffic — excluding buses, for Polish and Belarus nationals 24/7

SLOVENIA

Replacement of the information published in OJ C 210, 16.7.2011, p. 30.

Sea borders

(1)	Koper – Capodistria

(2)	Piran – Pirano

Air borders

(1)	Ljubljana–Brnik

(2)	Maribor–Slivnica

(3)	Portorož–Portorose

List of previous publications

OJ C 247, 13.10.2006, p. 25.

OJ C 77, 5.4.2007, p. 11.

OJ C 153, 6.7.2007, p. 22.

OJ C 164, 18.7.2008, p. 45.

OJ C 316, 28.12.2007, p. 1.

OJ C 134, 31.5.2008, p. 16.

OJ C 177, 12.7.2008, p. 9.

OJ C 200, 6.8.2008, p. 10.

OJ C 331, 31.12.2008, p. 13.

OJ C 3, 8.1.2009, p. 10.

OJ C 37, 14.2.2009, p. 10.

OJ C 64, 19.3.2009, p. 20.

OJ C 99, 30.4.2009, p. 7.

OJ C 229, 23.9.2009, p. 28.

OJ C 263, 5.11.2009, p. 22.

OJ C 298, 8.12.2009, p. 17.

OJ C 74, 24.3.2010, p. 13.

OJ C 326, 3.12.2010, p. 17.

OJ C 355, 29.12.2010, p. 34.

OJ C 22, 22.1.2011, p. 22.

OJ C 37, 5.2.2011, p. 12.

OJ C 149, 20.5.2011, p. 8.

OJ C 190, 30.6.2011, p. 17.

OJ C 203, 9.7.2011, p. 14.

OJ C 210, 16.7.2011, p. 30.

OJ C 271, 14.9.2011, p. 18.

OJ C 356, 6.12.2011, p. 12.

OJ C 111, 18.4.2012, p. 3.

OJ C 183, 23.6.2012, p. 7.

OJ C 313, 17.10.2012, p. 11.

OJ C 394, 20.12.2012, p. 22.

OJ C 51, 22.2.2013, p. 9.

OJ C 167, 13.6.2013, p. 9.

OJ C 242, 23.8.2013, p. 2.

OJ C 275, 24.9.2013, p. 7.

OJ C 314, 29.10.2013, p. 5.

OJ C 324, 9.11.2013, p. 6.

OJ C 57, 28.2.2014, p. 4.

OJ C 167, 4.6.2014, p. 9.

OJ C 244, 26.7.2014, p. 22.

OJ C 332, 24.9.2014, p. 12.

OJ C 420, 22.11.2014, p. 9.

OJ C 72, 28.2.2015, p. 17.

OJ C 126, 18.4.2015, p. 10.

OJ C 229, 14.7.2015, p. 5.

OJ C 341, 16.10.2015, p. 19.

OJ C 84, 4.3.2016, p. 2.

OJ C 236, 30.6.2016, p. 6.

OJ C 278, 30.7.2016, p. 47.

OJ C 331, 9.9.2016, p. 2.

OJ C 401, 29.10.2016, p. 4.

OJ C 484, 24.12.2016, p. 30.

OJ C 32, 1.2.2017, p. 4.

OJ C 74, 10.3.2017, p. 9.

OJ C 120, 13.4.2017, p. 17.

OJ C 152, 16.5.2017, p. 5.

OJ C 411, 2.12.2017, p. 10.

OJ C 31, 27.1.2018, p. 12.

OJ C 261, 25.7.2018, p. 6.

OJ C 264, 26.7.2018, p. 8.

OJ C 368, 11.10.2018, p. 4.

OJ C 459, 20.12.2018, p. 40.

OJ C 43, 4.2.2019, p. 2.

OJ C 64, 27.2.2020, p. 17.

OJ C 231, 14.7.2020, p. 2.

OJ C 58, 18.2.2021, p. 35.

OJ C 81, 10.3.2021, p. 27.

OJ C 184, 12.5.2021, p. 8.

OJ C 219, 9.6.2021, p. 9.

OJ C 279, 13.7.2021, p. 4.

OJ C 290, 20.7.2021, p. 10.

OJ C 380, 20.9.2021, p. 3.

OJ C 483, 1.12.2021, p. 19.

OJ C 201, 18.5.2022, p. 82.

OJ C 229, 14.6.2022, p. 8.

OJ C 241, 24.6.2022, p. 6.

OJ C 286, 27.7.2022, p. 33.

OJ C 335, 2.9.2022, p. 15.

OJ C 202, 9.6.2023, p. 33.

---

(1)  See the list of previous publications at the end of this update.

(2)  OJ L 77, 23.3.2016, p. 1.

(*1)  Note: These are exclusively operational during the summer period.

(*2)  Note: These are exclusively operational during the summer period.

Publication of a communication of approval of a standard amendment to a product specification for a name in the wine sector, as referred to in Article 17(2) and (3) of Commission Delegated Regulation (EU) 2019/33

(2023/C 290/06)

This communication is published in accordance with Article 17(5) of Commission Delegated Regulation (EU) 2019/33 (1).

COMMUNICATING THE APPROVAL OF A STANDARD AMENDMENT

‘Maremma toscana’

PDO-IT-A1413-AM03

Date of communication: 18.5.2023

DESCRIPTION OF AND REASONS FOR THE APPROVED AMENDMENT

1.   Indication of the term ‘Rosé’ as an alternative to the term ‘Rosato’ [rosé]

The option to indicate also the term ‘Rosé’ on the labels of Rosato wines has been added for the following product types: Rosato, Alicante Rosato, Grenache Rosato, Ciliegiolo Rosato, Merlot Rosato, Sangiovese Rosato, Syrah Rosato.

This option is intended to increase commercial opportunities, particularly in English-speaking markets.

The amendment concerns Articles 1, 2, 4, 5, 6 and 7 of the product specification and points 4 and 9 of the single document.

2.   Addition of Vermentino Superiore [superior] type

The new Vermentino Superiore type has been added.

The purpose of adding this type is to make the most of the qualities of the Vermentino variety by using different growing and wine-making techniques compared to those used for the basic Vermentino wine.

The amendment concerns Articles 1, 2, 4, 5, 6, 7, 8 and 9 of the product specification and points 4, 5 and 8 of the single document.

3.   Combination of grape varieties for the Vermentino Superiore type

The minimum percentage of the Vermentino grape variety has been increased to 95 % in the Superiore type, compared to 85 % in the basic type.

This makes the specific characteristics of the grape variety more distinctive.

The amendment concerns Article 2 of the product specification but does not affect the single document.

4.   Addition of agronomic requirements for the Vermentino Superiore type

The maximum grape production per hectare and the minimum natural alcoholic strength by volume have been added for this type.

This became necessary as a result of the introduction of this wine type and is in line with the requirements for the using the term ‘Superiore’.

The amendment concerns Article 4 of the product specification and point 5.2 of the single document.

5.   Adjustments to the form

The Canaiolo type has been added to the list showing the requirements for release for consumption.

The Merlot Passito [raisined] type has been added to the list showing the grape-to-wine yields and maximum wine production.

This corrects a simple clerical error in the previous versions.

The amendments concern Article 5 of the product specification but do not affect the single document.

6.   Rules on winemaking and release for consumption of the Vermentino Superiore type

The maximum grape-to-wine yield, maximum wine production per hectare and requirements for release for consumption have been added for this type.

The yield and maximum wine production per hectare have been specified in line with the agronomic requirements laid down for this type of wine. Furthermore, laying down a minimum period before the product is released for consumption means it can be differentiated both in terms of quality and on the market.

The amendments concern Article 5 of the product specification but do not affect the single document.

7.   Description of the Vermentino Superiore wine type

The chemical, physical and organoleptic descriptors have been added for the new wine type.

The product’s characteristics on consumption mean that wines made from the Vermentino grape variety qualified with the term Superiore can be clearly identified.

The amendment concerns Article 6 of the product specification and point 4 of the single document.

8.   Adjustment to the rules on labelling

The term ‘Rosé’ has been added as an alternative to the word ‘Rosato’ for rosé wines.

The term ‘Superiore’ has been deleted from the list of descriptors that may not be used on labelling.

These adjustments are consistent with the changes made to the Maremma toscana PDO designation.

The amendments concern Article 7 of the product specification but do not affect the single document.

9.   Adjustment to the rules on packaging

The minimum capacity of bag in box containers has been reduced from 3 litres to 2 litres. Furthermore, containers made of glass alternatives polyethylene terephthalate (PET) and plastic-coated paper (Brik) have been prohibited. The reduction in the minimum capacity for bag in box containers will make it possible to improve marketing opportunities for the products on EU and international markets as it meets the needs of many consumers who welcome this small size. PET and Brik containers have been prohibited in order to preserve the image of the PDO product presented to the consumer.

Only glass bottles may be used for Superiore types, as is already the case for Riserva [reserve], Vigna [vineyard], Passito, Vin Santo [holy wine] and Vendemmia tardiva [late harvest]. This is to further enhance the image of the products. Additionally, the maximum capacity of the bottles has been increased to 18 litres for these types in order to meet the requirements of markets where, for some types of high-quality wines, there is a demand for large sizes that can be used for mainly promotional purposes.

The amendments concern Article 8 of the product specification and point 9 of the single document.

10.   Adjustments to the form in the section on the link with the geographical environment

The description of the link has been adapted following the introduction of the new Vermentino Superiore type.

This is a change to the form of the text to include references to the above wine type.

The amendment concerns Article 9 of the product specification but does not affect the single document.

SINGLE DOCUMENT

1.   Name(s)

Maremma toscana

2.   Geographical indication type

PDO - Protected Designation of Origin

3.   Categories of grapevine product

1.

Wine

4.	Sparkling wine

5.	Quality sparkling wine

4.   Description of the wine(s)

1.   Bianco [white] including Bianco Riserva [white reserve], with indication of one or two grape varieties

CONCISE TEXTUAL DESCRIPTION

Colour: straw yellow of varying intensity. Aroma: fine and delicate, with mainly fruity notes in the Viognier and Ansonica; broader and more complex in the Riserva [reserve] version. Taste: from dry to medium-dry in the Bianco; soft and velvety in the Vermentino, Viognier and Ansonica; fresher, with spicy notes, flavourful and full-bodied in the Riserva version. Minimum total alcoholic strength by volume: Bianco: 10,50 %; Ansonica, Viognier, Vermentino, Chardonnay, Sauvignon, Trebbiano: 11,00 %; Riserva: 12,00 %. Minimum sugar-free extract: Bianco: 14,00 g/l; Ansonica, Viognier, Vermentino, Chardonnay, Sauvignon, Trebbiano: 16 g/l; Riserva: 18 g/l. Any analytical parameters not shown in the table below comply with the limits laid down in national and EU legislation.

General analytical characteristics
Maximum total alcoholic strength (in % volume)
Minimum actual alcoholic strength (in % volume)
Minimum total acidity	4,50 grams per litre expressed as tartaric acid
Maximum volatile acidity (in milliequivalents per litre)
Maximum total sulphur dioxide (in milligrams per litre)

2.   Vermentino Superiore [superior]

CONCISE TEXTUAL DESCRIPTION

Colour: bright straw yellow, sometimes with hints tending to golden. Aroma: delicate, distinctive, fine. Taste: dry, flavourful, soft, velvety. Minimum total alcoholic strength by volume: 12,50 %. Minimum sugar-free extract: 20,0 g/l.

General analytical characteristics
Maximum total alcoholic strength (in % volume)
Minimum actual alcoholic strength (in % volume)
Minimum total acidity	4,5 grams per litre expressed as tartaric acid
Maximum volatile acidity (in milliequivalents per litre)
Maximum total sulphur dioxide (in milligrams per litre)

3.   Rosso [red], including Rosso Novello [new] and Rosso Riserva, with indication of one or two grape varieties

CONCISE TEXTUAL DESCRIPTION

Colour: ruby red of varying intensity with hints of purple; intense red, tending to garnet with age.

Aroma: with fruity notes in the Novello, Alicante/Grenache, Merlot, Pugnitello and Sangiovese wines and spicy notes in the Cabernet Franc, Cabernet Sauvignon, Syrah and Petit Verdot; the aroma is more delicate in the Ciliegiolo, tending to become more refined during ageing in the Riserva wines.

Taste: from dry to medium-dry in the Rosso, and slightly acidic and flavourful in the Novello, Alicante/Grenache; with more body in the Cabernet, Cabernet Franc, Cabernet Sauvignon, Ciliegiolo, Petit Verdot, Pugnitello, Sangiovese and Merlot, and also in the Riserva wines; intense and spicy in the Syrah; and lively and full in the Rosso and Sangiovese types subject to the Governo all’uso toscano technique.

Minimum total alcoholic strength by volume: Rosso, Novello: 11,00 %; Alicante/Grenache, Cabernet, Cabernet Franc, Cabernet Sauvignon, Canaiolo, Merlot, Petit Verdot, Pugnitello, Sangiovese and Ciliegiolo, Syrah: 11,50 %; Riserva: 12,00 %.

Minimum sugar-free extract: Rosso: 22,00 g/l; Novello: 20,00 g/l; Alicante/Grenache, Cabernet, Cabernet Franc, Cabernet Sauvignon, Canaiolo, Merlot, Petit Verdot, Pugnitello, Sangiovese and Ciliegiolo, Syrah: 22 g/l; Riserva 24,00 g/l.

Any analytical parameters not shown in the table below comply with the limits laid down in national and EU legislation.

General analytical characteristics
Maximum total alcoholic strength (in % volume)
Minimum actual alcoholic strength (in % volume)
Minimum total acidity	4,50 grams per litre expressed as tartaric acid
Maximum volatile acidity (in milliequivalents per litre)
Maximum total sulphur dioxide (in milligrams per litre)

4.   Rosato [rosé] / Rosé, with indication of the grape variety

CONCISE TEXTUAL DESCRIPTION

Colour: pink of varying intensity.

Aroma: delicate, with intense fruity notes, more persistent in the Alicante, and more delicate in the Sangiovese.

Taste: from dry to medium-dry, slightly acidic, harmonious.

Minimum total alcoholic strength by volume: 10,50 %.

Minimum sugar-free extract: 16,00 g/l.

Any analytical parameters not shown in the table below comply with the limits laid down in national and EU legislation.

General analytical characteristics
Maximum total alcoholic strength (in % volume)
Minimum actual alcoholic strength (in % volume)
Minimum total acidity	4,50 grams per litre expressed as tartaric acid
Maximum volatile acidity (in milliequivalents per litre)
Maximum total sulphur dioxide (in milligrams per litre)

5.   Vin Santo [holy wine]

CONCISE TEXTUAL DESCRIPTION

Colour: from straw yellow to amber to brown.

Aroma: redolent of ether, warm and distinctive.

Taste: from dry to sweet, harmonious and velvety.

Minimum total alcoholic strength by volume: 16,00 %.

Minimum sugar-free extract: 22,00 g/l.

Any analytical parameters not shown in the table below comply with the limits laid down in national and EU legislation.

General analytical characteristics
Maximum total alcoholic strength (in % volume)
Minimum actual alcoholic strength (in % volume)	12,00
Minimum total acidity	4,50 grams per litre expressed as tartaric acid
Maximum volatile acidity (in milliequivalents per litre)	30,00
Maximum total sulphur dioxide (in milligrams per litre)

6.   Vendemmia tardiva [late harvest], with indication of the grape variety

CONCISE TEXTUAL DESCRIPTION

Colour: from intense straw yellow to golden yellow of varying intensity.

Aroma: delicate, intense, occasionally spicy.

Taste: from dry to sweet, full and harmonious.

Minimum total alcoholic strength by volume: 15,00 %.

Minimum sugar-free extract: 22,00 g/l.

Any analytical parameters not shown in the table below comply with the limits laid down in national and EU legislation.

General analytical characteristics
Maximum total alcoholic strength (in % volume)
Minimum actual alcoholic strength (in % volume)
Minimum total acidity	4,50 grams per litre expressed as tartaric acid
Maximum volatile acidity (in milliequivalents per litre)	25
Maximum total sulphur dioxide (in milligrams per litre)

7.   Passito Bianco [raisined white], including with indication of grape variety

CONCISE TEXTUAL DESCRIPTION

Colour: from golden yellow to amber of varying intensity.

Aroma: intense, of ripe fruit.

Taste: from dry to sweet, round and velvety.

Minimum total alcoholic strength by volume: 15,50 %.

Minimum sugar-free extract: 23,00 g/l.

Any analytical parameters not shown in the table below comply with the limits laid down in national and EU legislation.

General analytical characteristics
Maximum total alcoholic strength (in % volume)
Minimum actual alcoholic strength (in % volume)	12,00
Minimum total acidity	4,50 grams per litre expressed as tartaric acid
Maximum volatile acidity (in milliequivalents per litre)	25
Maximum total sulphur dioxide (in milligrams per litre)

8.   Passito Rosso [raisined red], including with indication of grape variety

CONCISE TEXTUAL DESCRIPTION

Colour: intense ruby red.

Aroma: intense, broad.

Taste: from dry to sweet, velvety.

Minimum total alcoholic strength by volume: 15,50 %.

Minimum sugar-free extract: 24,00 g/l.

Any analytical parameters not shown in the table below comply with the limits laid down in national and EU legislation.

General analytical characteristics
Maximum total alcoholic strength (in % volume)
Minimum actual alcoholic strength (in % volume)	12,00
Minimum total acidity	4,50 grams per litre expressed as tartaric acid
Maximum volatile acidity (in milliequivalents per litre)	25
Maximum total sulphur dioxide (in milligrams per litre)

9.   Sparkling wine and Quality sparkling wine - Bianco, including with indication of the grape variety, and Rosato/Rosé

CONCISE TEXTUAL DESCRIPTION

Colour: straw yellow of varying intensity; in the Ansonica, bright straw yellow; occasionally with greenish hints in the Vermentino; from pale to cherry pink in the Rosato/Rosé.

Foam: fine and long-lasting.

Aroma: fine, fruity, long-lasting, lighter in the Ansonica, more delicate in the Vermentino, with more marked fruity notes in the Rosato/Rosé.

Taste: zero dosage to extra dry, harmonious in the Ansonica; lively, acidic, slightly bitter in the Rosato/Rosé.

Minimum total alcoholic strength by volume: Bianco and Rosato: 10,50 %; Ansonica and Vermentino: 11,00 %.

Minimum sugar-free extract: Bianco 14,00 g/l; Ansonica, Vermentino, Rosato/Rosé: 16,00 g/l.

Any analytical parameters not shown in the table below comply with the limits laid down in national and EU legislation.

General analytical characteristics
Maximum total alcoholic strength (in % volume)
Minimum actual alcoholic strength (in % volume)
Minimum total acidity	4,50 grams per litre expressed as tartaric acid
Maximum volatile acidity (in milliequivalents per litre)
Maximum total sulphur dioxide (in milligrams per litre)

5.   Wine-making practices

5.1.   Specific oenological practices

1.   Vin Santo wine-making method

Specific oenological practice

After undergoing a careful selection process, the grapes must be naturally dried in suitable premises until they reach an adequate sugar content, before pressing. The wine must be made, stored, and aged in wooden containers with a maximum capacity of 500 litres, and may not be released for consumption before 1 March of the 3rd year following the year in which the grapes were produced.

2.   Governo all’uso toscano wine-making method

Specific oenological practice

The traditional method, permitted for the Rosso and Sangiovese types, whereby fermentation is slowly restarted by adding slightly dried black grapes (at least 10 kg per hectolitre) that, before pressing, have begun fermentation.

5.2.   Maximum yields:

1.	Bianco, Bianco Riserva and Spumante 13 000 kilograms of grapes per hectare

2.	Bianco, Bianco Riserva and Spumante 91,00 hectolitres per hectare

3.	Rosso, Rosso Riserva, Rosato, Rosato Spumante and Novello 12 000 kilograms of grapes per hectare

4.	Rosso, Rosso Riserva, Rosato, Rosato Spumante and Novello 84,00 hectolitres per hectare

5.	Vin Santo 13 000 kilograms of grapes per hectare

6.	Vin Santo 45,50 hectolitres per hectare

7.	Ansonica, Ansonica Spumante, Chardonnay, Sauvignon, Trebbiano, Vermentino, Vermentino Spumante and Viognier 12 000 kilograms of grapes per hectare

8.	Ansonica, Ansonica Spumante, Chardonnay, Sauvignon, Trebbiano, Vermentino, Vermentino Spumante and Viognier 84,00 hectolitres per hectare

9.	Vermentino Superiore 9 000 kilograms of grapes per hectare

10.	Vermentino Superiore 63,00 hectolitres per hectare

11.	Alicante, Cabernet, Cabernet Sauvignon, Cabernet Franc, Canaiolo, Ciliegiolo, Merlot, Petit Verdot, Sangiovese and Syrah 11 000 kilograms of grapes per hectare

12.	Alicante, Cabernet, Cabernet Sauvignon, Cabernet Franc, Canaiolo, Ciliegiolo, Merlot, Petit Verdot, Sangiovese and Syrah 77,00 hectolitres per hectare

13.	Pugnitello 9 000 kilograms of grapes per hectare

14.	Pugnitello 63,00 hectolitres per hectare

15.	Alicante Rosato, Ciliegiolo Rosato, Merlot Rosato, Sangiovese Rosato and Syrah Rosato 11 000 kilograms of grapes per hectare

16.	Alicante Rosato, Ciliegiolo Rosato, Merlot Rosato, Sangiovese Rosato and Syrah Rosato 77,00 hectolitres per hectare

17.	Passito Bianco, Ansonica Passito, Chardonnay Passito, Sauvignon Passito and Vermentino Passito 11 000 kilograms of grapes per hectare

18.	Passito Bianco, Ansonica Passito, Chardonnay Passito, Sauvignon Passito and Vermentino Passito 44,00 hectolitres per hectare

19.	Passito Rosso, Cabernet Passito, Cabernet Sauvignon Passito, Ciliegiolo Passito, Merlot Passito and Sangiovese Passito 11 000 kilograms of grapes per hectare

20.	Passito Rosso, Cabernet Passito, Cabernet Sauvignon Passito, Ciliegiolo Passito, Merlot Passito and Sangiovese Passito 44,00 hectolitres per hectare

21.	Vendemmia tardiva, Ansonica Vendemmia tardiva, Chardonnay Vendemmia tardiva and Sauvignon Vendemmia tardiva 80 000 kilograms of grapes per hectare

22.	Vendemmia tardiva, Ansonica Vendemmia tardiva, Chardonnay Vendemmia tardiva and Sauvignon Vendemmia tardiva 40,00 hectolitres per hectare

23.	Trebbiano Vendemmia tardiva, Vermentino Vendemmia tardiva and Viognier Vendemmia tardiva 80 000 kilograms of grapes per hectare

24.	Trebbiano Vendemmia tardiva, Vermentino Vendemmia tardiva and Viognier Vendemmia tardiva 40,00 hectolitres per hectare

6.   Demarcated geographical area

The area of production falls within the region of Tuscany and, specifically, covers the entire province of Grosseto.

7.   Wine grape variety(-ies)

Alicante N. - Grenache

Ansonica B. - Inzolia

Cabernet Franc N. - Cabernet

Cabernet Sauvignon N. - Cabernet

Canaiolo Nero N. - Canaiolo

Carmenère N. - Cabernet

Chardonnay B.

Ciliegiolo N.

Malvasia Istriana B. - Malvasia

Malvasia Bianca Lunga B. - Malvoisier

Malvasia Bianca di Candia B. - Malvasia

Merlot N.

Petit Verdot N.

Pugnitello N.

Sangiovese N. - Sangioveto

Sauvignon B. - Sauvignon Blanc

Syrah N.

Trebbiano Toscano B. - Procanico

Vermentino B. - Pigato B.

Viognier B.

8.   Description of the link(s)

8.1.   ‘Maremma toscana’ PDO - Wine including Vin Santo, Vendemmia tardiva and Passito

The area consists largely of hills and foothills, with moderate rainfall and scarce summer rain. The deep soils favour root development and have a good drainage capacity. It is a historical wine-growing area dating back to the Etruscans, which, over the centuries, has been considered ideal for growing vines, most of which have been trained using the spurred cordon method with a high planting density. The varieties used are both traditional to the area (Trebbiano Toscano, Ansonica, Vermentino, Vermentino Superiore, Sangiovese and Ciliegiolo), and more modern (Chardonnay, Sauvignon, Viognier, Merlot, Cabernet and Syrah), producing highly characteristic wines that are fresh, aromatic and well-structured.

8.2.   ‘Maremma toscana’ PDO - Sparkling wine and Quality sparkling wine

The area consists largely of hills and foothills, with moderate rainfall, scarce summer rain, and good ventilation. The deep soils favour root development and have a good drainage capacity. The traditional production of sparkling wines is also linked to the presence of natural cellars hewn out of the tuff stone, which allow optimal temperatures to be maintained. The vineyards have had high planting densities since ancient times. The varieties used are those traditional to the area (Trebbiano Toscano, Vermentino and Ansonica), to which other more modern varieties are sometimes added (Chardonnay, Sauvignon), that give the wines fresh, slightly acidic, fine and fruity characteristics.

9.   Essential further conditions (packaging, labelling, other requirements)

Labelling

Legal framework:

EU legislation

Type of further condition:

Additional provisions relating to labelling

Description of the condition:

The synonym Grenache has been specified as an alternative name for the Alicante variety.

The possibility of using the term ‘Rosé’ as an alternative to the word ‘Rosato’ has been specified for rosé wines

Wine-making area of the products

Legal framework:

EU legislation

Type of further condition:

Derogation from production in the demarcated geographical area

Description of the condition:

In addition to the provinces of Pisa, Livorno, Siena and Florence, the province of Arezzo has been added to the list of areas where wine-making operations may be carried out for the production of wines covered by the PDO.

Indication of grape variety

Legal framework:

EU legislation

Type of further condition:

Additional provisions relating to labelling

Description of the condition:

The option has been added to specify on the label two grape varieties of the same colour from those indicated in the product specification, which must be listed in descending order with respect to the actual amount of grapes used, under Article 50(1)(a)(ii) of Regulation (EU) 2019/33.

Rules on packaging

Legal framework:

EU legislation

Type of further condition:

Additional provisions relating to labelling

Description of the condition:

Any containers with a nominal volume permitted by the legislation in force may be used, including containers of a material other than glass consisting of a wine skin of polyethylene or polyester multi-layered plastic enclosed in a box made of cardboard or any other rigid material, exclusively for volumes of between 2 and 5 litres.

Containers such as demijohns and carboys, and containers of a material other than glass such as polyethylene terephthalate (PET) and plastic-coated paper (Brik) may not be used.

Any type of closure permitted by legislation, with the exception of crown caps, may be used for wines in glass bottles.

For wines bearing the terms ‘Riserva’, ‘Superiore’ and ‘Vigna’ and wines of the Passito, Vin Santo and Vendemmia tardiva types, the only containers permitted are glass bottles with a shape and presentation befitting of fine wine, with a nominal volume of up to 18 litres and a closure other than a crown cap.

Link to the product specification

Https://www.politicheagricole.it/flex/cm/pages/serveblob.php/L/IT/idpagina/19593

---

(1)  OJ L 9, 11.1.2019, p. 2.