Commission Delegated Regulation Research Articles

Bioactive Compounds in the Oils of the Autochthonous Slovenian Olive Varieties 'Buga', 'Črnica' and 'Drobnica'.

The adaptation of autochthonous olive varieties to local soil and climatic conditions can lead to a unique chemical composition and characteristics of olive oils that may differ from the generally accepted quality standards set out in the International Olive Oil Council strategy documents and EU regulations. Therefore, the fatty acid composition, biophenol, tocopherol, sterol and triterpenic dialcohol content and composition of the autochthonous Slovenian olive varieties 'Buga', 'Črnica' and 'Drobnica' were studied for a three-year period with the aim of valorising the characteristics of the three olive varieties. Standardised and accredited analytical methods in accordance with SIST EN ISO/IEC 17025:2017 were applied. The results of the investigation showed that the highest average amount of oleic acid (75.75%) was found in the oils of the 'Črnica' variety, followed by the 'Drobnica' (72.06%) and the 'Buga' (68.73%). All three varieties are a good source of total biophenols ('Buga' 616 mg/kg, 'Drobnica' 569 mg/kg and 'Črnica' 427 mg/kg) and α-tocopherol ('Buga' 378 mg/kg, 'Drobnica' 279 mg/kg, and 'Črnica' 243 mg/kg). 'Buga' and 'Drobnica' are characterised by high amounts of total sterols, 2468 mg/kg and 2391 mg/kg, respectively, while 'Črnica' oils, in comparison, showed a lower average value of total sterols (1351 mg/kg). Due to their exceptional chemical composition, 'Buga', 'Črnica' and 'Drobnica' show great potential for the further cultivation and valorisation of traditional olive oil production in the region, thus contributing to the preservation of biodiversity and local traditions. The quality parameters of olive oil from the autochthonous Slovenian olive varieties 'Buga', 'Črnica' and 'Drobnica' also fulfil the limits for extra virgin olive oil according to the Commission Delegated Regulation (EU) 2022/2104, despite local climatic influences. However, accelerated growth due to climatic changes affecting early harvest can lead to them falling outside these limits, which was observed in particular for the 'Buga' variety in terms of the linoleic acid content. This study emphasises the importance of timing the harvest to achieve optimum maturity and meet EU quality standards, taking into account the genetic makeup of the varieties and their response to the current climatic conditions.

How Botswana and Mauritius Exited the EU High-Risk Third Country List by Adapting Their Approaches to Beneficial Ownership and Residence

On 22 February 2022, the Mauritian Ministry of Financial Services and Good Governance issued a communique reporting the country’s removal from the European Union (‘EU’) List of High-Risk Third Countries. This list is also called the Anti-money Laundering and Countering Terrorist Financing List (‘AML/CTF’); or, less affectionately, the Blacklist. Mauritius issued this report a month after the European Union released its Commission Delegated Regulation (EU) 2022/229, removing Botswana and Mauritius from the AML/CTF. The EU placed Mauritius and Botswana on the Blacklist in May 2020 after adopting updated criteria for assessing high-risk third countries and publishing its revised methodology for identifying these high-risk jurisdictions. These updated criteria and procedures relegated the tax regimes of Mauritius and Botswana as strategically ‘[deficient] on anti-money laundering and counter-terrorist financing…,’ such that they ‘pose significant threats to the financial system of the Union.’ Placement on the Blacklist encumbers States with increased monitoring, regulatory requirements, and global trade restrictions that can result in a heavy economic toll. Moreover, to exit the list, countries must remediate deficiencies in cooperation with the EU and Financial Action Task Force (‘FATF’), each of which must be satisfied with the improvements made. Mauritius and Botswana passed a bevy of substantial laws in just over a year to satisfy the EU and FATF, earning an exit from the Blacklist. Among the many changes, enhancements to each country’s transparency measures were central. Adopting new approaches to beneficial ownership and residence in each country is at the core of this transparency. This work will explore how Mauritius and Botswana leveraged new approaches to beneficial ownership and residence to meet EU standards for tax regime transparency, resulting in each country’s removal from the EU Blacklist. This analysis will begin with an economic overview of Mauritius and Botswana. What follows will be an introduction to the EU AML/CTF list, followed by how and why the EU placed Mauritius and Botswana on the list. Finally, this work will look at how Mauritius and Botswana exited the list, and what that exit means for each country and other countries like them.

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2024 in the context of commission delegated regulation (EU) 2018/772.

This report comprises the 14th assessment of the Echinococcus multilocularis surveillance scientific reports, provided by Finland, Ireland, United Kingdom (Northern Ireland) and Norway on their respective surveillance programmes. Every year since 2012, EFSA presents the assessment to the European Commission in which the sampling strategy, data collection and detection methods used by these countries are evaluated. More specifically, the surveillance programmes of these four countries are evaluated by checking the information submitted by each of them and verifying that the technical requirements are fulfilled as laid down in Commission Delegated Regulation (EU) 2018/772 of 21 November 2017 supplementing Regulation (EU) No 576/2013 of the European Parliament and of the Council with regard to preventive health measures for the control of Echinococcus multilocularis infection in dogs, and repealing Delegated Regulation (EU) No 1152/2011. The information is divided into four different categories for assessment: the type and sensitivity of the detection method, the selection of the target population, the sampling strategy and the methodology. For each category, the main aspects that need to be considered in order to accomplish the technical requirements of the legislation are checked against compliance of several criteria. The countries participating in this surveillance (Finland, Ireland, the United Kingdom (Northern Ireland) and Norway) succeeded in the fulfilment of the technical legal requirements foreseen in Commission Delegated Regulation (EU) 2018/772 concerning these four different categories. None of the four countries recorded positive samples in the 12-month reporting period.

Comprehensive Screening of Salinomycin in Feed and Its Residues in Poultry Tissues Using Microbial Inhibition Tests Coupled to Enzyme-Linked Immunosorbent Assay (ELISA).

Salinomycin is a coccidiostat approved as a feed additive for the prevention of coccidiosis in poultry. Official control of its residues is set by the Commission Delegated Regulation (EU) 2022/1644. The aim of our study was to assess the suitability of three microbial inhibition tests (MITs), Premi®Test, Explorer 2.0, and the Screening Test for Antibiotic Residues (STAR) linked to the enzyme-linked immunosorbent assay (ELISA), for the screening of salinomycin residues in the tissues of broiler chickens (breast and thigh muscle, heart, liver, gizzard, kidneys, lungs, spleen, skin, and fat) fed commercially produced feed containing 70 mg.kg-1 of salinomycin in the complete feed. The first residue screening (Sampling A) was performed on the last day of administration of the salinomycin-medicated feed (day 30), and the second screening (Sampling B) was performed on the day of slaughter (day 37) after the expiry of the withdrawal period with the feeding of non-medicated feed. Based on the quantitative confirmation of salinomycin residues in the examined chicken tissues by the ELISA method (Sampling A from 0.025 to 0.241 mg.kg-1; Sampling B from 0.003 to 0.076 mg.kg-1), all the MITs with the preference of the bacterial strain Bacillus stearothermophilus var. calidolactis ATCC 10149 demonstrated the ability to detect the residues of salinomycin in the examined tissues of broiler chickens at the level of the maximum residue limits set from 0.015 to 0.150 mg.kg-1 by Commission Implementing Regulation (EU) 2017/1914 and confirmed the relevance of their sensitivity to the coccidiostat salinomycin.

Biological Containment for African Swine Fever (ASF) Laboratories and Animal Facilities: The Italian Challenge in Bridging the Present Regulatory Gap and Enhancing Biosafety and Biosecurity Measures

The African Swine Fever Virus (ASFV) is a DNA virus of the Asfarviridae family, Asfivirus genus. It is responsible for massive losses in pig populations and drastic direct and indirect economic impacts. The ever-growing handling of ASFV pathological material in laboratories, necessary for either diagnostic or research activities, requires particular attention to avoid accidental virus release from laboratories and its detrimental economic and environmental effects. Recently, the Commission Delegated Regulation (EU) 2020/689 of 17 December 2019 repealed the Commission Decision of 26 May 2003 reporting an ASF diagnostic manual (2003/422/EC) with the minimum and supplementary requirements for ASF laboratories. This decision generated a regulatory gap that has not been addressed yet. This paper aims to describe the Italian National Reference Laboratory (NRL) efforts to develop an effective and reliable biological containment tool for ASF laboratories and animal facilities. The tool consists of comprehensive and harmonized structural and procedural requirements for ASF laboratories and animal facilities that have been developed based on both current and repealed legislation, further entailing a risk assessment and internal audit as indispensable tools to design, adjust, and improve biological containment measures.

Występowanie i zwalczanie wysoce zjadliwej grypy ptaków w krajach Unii Europejskiej, w tym w Polsce w sezonie 2020/2021

Highly pathogenic avian influenza is one of the most contagious and dangerous infectious animal diseases of the twenty first century. Its recurring outbreaks in recent years have been increasing in scope and have resulted in previously unrecorded losses in poultry production, related to both its high mortality rate and the need to kill poultry in outbreaks, as well as economic losses related to trade restrictions imposed on affected countries and regions. An increase in the average duration of the so-called „flu season” was also observed. This is related to the shift in the phenological calendar observed in nature, which was created based on the analysis of climatic factors, weather and the impact on animal behavior. Currently, in the countries of the European Union, the direct legal basis for the control of highly pathogenic avian influenza in the EU, is provided by the provisions of Regulation (EU) 2016/429 of the European Parliament and of the Council (EU) (Animal Health Law, AHL), while the detailed manner and mode of control of this disease is defined in the Commission Delegated Regulation (EU) 2020/687 of December 17, 2019.

ОЦІНКА ВІДПОВІДНОСТІ ПАРАМЕТРІВ СВІТЛОДІОДНИХ ДЖЕРЕЛ СВІТЛА ВИМОГАМ НОВИХ РЕГЛАМЕНТІВ КОМІСІЇ ЄС 2019/2020 та ЄС 2019/2015

The results of studies of the energy efficiency and functional parameters of non-directional LED lamps for replacing incandescent lamps, which are supplied to Ukraine as aid for reducing electricity costs for lighting in the residential sector, and their compliance with the new requirements of the Commission Regulation (EU) 2019/2020 on establishing requirements are presented to ecodesign for light sources and Commission Delegated Regulation (EU) 2019/2015 on energy labeling of light sources, which entered into force in EU countries in 2021. In Ukraine, national technical regulations are being developed on the basis of these regulations. The following parameters of LED lamps with a power of 5-12 W were measured: power consumption, power factor, useful luminous flux, correlated color temperature, uniformity of color, color rendering index, short-term indicator of light flickering, indicator of the visibility of the stroboscopic effect, coefficient of preservation of luminous flux after 3000 hours of operation of the lamps and others The maximum power allowed by the Regulation was calculated, which is defined as a function of the declared useful luminous flux and the declared color rendering index, as well as energy efficiency classes in accordance with the requirements of the new energy labeling, the service life of the lamps was estimated according to the experimentally determined coefficient of preservation of the luminous flux and according to the data of the service life declared by the manufacturer. It is shown that most of the parameters of LED lamps entering Ukraine meet the requirements of the new Commission (EU) Regulations and despite the identified inconsistencies among individual manufacturers, there have been successes in increasing the energy efficiency and quality of LED lamps over the last decade. Keywords: Commission Regulations (EU), LED light sources, energy efficiency, functional parameters.

Licensing Requirements for Avian Vaccines Within the European Union.

Avian vaccines are a key factor when it comes to ensuring the availability of products derived from healthy poultry and preventing the transmission of infections from domestic and wildlife birds to humans. A marketing authorization for veterinary vaccines is granted after the product's quality, safety, and efficacy have been confirmed. During the licensing procedure, the manufacturing process is assessed to guarantee consistent quality and stability of the vaccine components. Furthermore, both the safety for the target species and the risk for the user, the consumer, and the environment must be demonstrated. In addition, specific tests and studies are required to support the efficacy of the vaccine. The authorization procedures and related licensing requirements for avian vaccines to be marketed in the European Union (EU) based on the requirements of Regulation (EU) 2019/6 Article 8 and the Commission Delegated Regulation (EU) 2021/805 amending Annex II to Regulation (EU) No. 2019/6 are explained in the paper.

The application of EN ISO 52016-1 to assess building cost-optimal energy performance levels in Italy

In Italy, the cost-optimisation calculation procedure, based on the comparative methodology framework established by the Commission Delegated Regulation 244/2012 to derive minimum energy performance requirements of buildings, was firstly applied by means of a monthly quasi-steady-state calculation method based on EN ISO 13790. The introduction of the new EN ISO 52016-1 simplified hourly calculation method determined the possibility of testing the new assessment procedure. The aim of this work is to analyse the deviation between the monthly and hourly calculation methods in the assessment of the building energy needs for space heating and cooling and in the selection of cost-optimal solutions. The cost-optimisation analysis was hence performed on a group of buildings representative of the Italian building stock. The results of the monthly and hourly methods in terms of cost-optimal levels and packages of energy efficiency measures were then compared. Results show limited variations in the resulting global cost, while differences in the cost-optimal packages of energy efficiency measures are not negligible. A sensitivity analysis of the main economic parameters was carried out, pointing out the main influencing factors.

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2023 in the context of commission delegated regulation (EU) 2018/772.

This report is part of the Echinococcus multilocularis surveillance scientific reports which are presented annually by EFSA to the European Commission and are intended to assess the sampling strategy, data collection and detection methods used by Finland, Ireland, United Kingdom (Northern Ireland) and Norway in their respective surveillance programmes. The surveillance programmes of these fourcountries were evaluated by checking the information submitted by each of them and verifying that the technical requirements were fulfilled as laid down in Commission Delegated Regulation (EU) 2018/772 of 21 November 2017 supplementing Regulation (EU) No 576/2013 of the European Parliament and of the Council with regard to preventive health measures for the control of Echinococcus multilocularis infection in dogs, and repealing Delegated Regulation (EU) No 1152/2011. The information was divided into four different categories for assessment: the type and sensitivity of the detection method, the selection of the target population, the sampling strategy and the methodology. For each category, the main aspects that need to be considered in order to accomplish the technical requirements of the legislation were checked against compliance of several criteria. The countries participating in this surveillance (Finland, Ireland, Norway and United Kingdom [Northern Ireland]) succeeded in the fulfilment of the technical legal requirements foreseen in Commission Delegated Regulation (EU) 2018/772 concerning these four different categories None of the four countries recorded positive samples in the 12-month reporting period.

The EU’s New Energy and Climate Policy: Energy Security and the Moderation of Environmental Standards

The article analyzes the evolution of the EU's energy and climate policy to explain that since Russia invaded Ukraine, a reformulation has occurred, characterized by the reconciliation of climate objectives with energy security and the flexibility of the environmental dimension. This rearrangement of the objectives of environmental policies has begun to take shape with the REPowerUE Plan, an energy package with which the EU intends to respond to the two dimensions of Europe's energy crisis: the need to deepen the transition towards climate neutrality and the duty to abandon dependence on Russian hydrocarbons. The review is based on two specific measures: Commission Delegated Regulation (EU) 2022/1214 and Council Regulation EU 2022/2577, key regulations for the massive deployment of renewable energies.

Galileo-Based Doppler Shifts and Time Difference Carrier Phase: A Static Case Demonstration.

The European Commission is designing and implementing new regulations for vehicle navigation in different sectors. Commission Delegated Regulation 2017/79 defines the compatibility and performance of the 112-based eCall in-vehicle systems. The regulation has a large impact on road transportation because it requires that all cars and light duty vehicles must be equipped with eCall devices. For heavy duty vehicles, a set of new regulations has been developed, starting from EU Regulation No 165/2014, in which the concept of smart tachographs was introduced to enforce the EU legislation on professional drivers' driving and resting times. In addition, intelligent speed assistance (ISA) devices increase the safety of road users. These new devices fully exploit the Global Navigation Satellite System (GNSS) to compute position velocity and time (PVT) information. In all these systems, the velocity of the vehicle plays a fundamental role; hence, a reliable and accurate velocity estimate is of utmost importance. In this work, two methods for velocity estimation using Galileo are presented and compared. The first exploits Doppler shift measurements, while the second uses time difference carrier phase (TDCP) measurements. The Doppler-based technique for velocity estimation is widely adopted in current devices, while the TDCP technique is emerging due to its promising high accuracy. The two methods are compared considering all the Galileo signals including E1, E5a, E5b, E5 Alt BOC and E6. The methods are compared in terms of velocity errors for both horizontal and vertical components using real static data. From the tests performed, it emerged that the TDCP has increased performance with respect to the Doppler-based solution. Among the Doppler-based solutions, the most accurate solution is the one obtained with the E5 Alt BOC signal.

Insights into UK investment firms’ efforts to comply with MiFID II RTS 6 that governs the conduct of algorithmic trading

PurposeThe purpose of this paper is to examine the effectiveness of UK investment firms’ implementation of the requirements in Commission Delegated Regulation 2017/589 (more commonly known as “Regulatory Technical Standard 6” or “RTS 6”) that govern the conduct of algorithmic trading activities.Design/methodology/approachA qualitative examination of 19 semi-structured interviews with practitioners working for, or with, UK investment firms engaged in algorithmic trading activities.FindingsThe paper finds that practitioners generally have a good understanding of the requirements in RTS 6. Some lack knowledge of algorithms, coding and algorithmic strategies but have used best efforts to implement RTS 6. However, regulatory fatigue, complacency, cost pressures, governance in international groups, overreliance on external knowledge and generous risk parameter calibration threaten to undermine these efforts.Research limitations/implicationsThe study’s findings are limited to the participants’ insights. Some areas of the RTS 6 regime attracted little comment from participants.Practical implicationsThe paper proposes the introduction of mandatory algorithmic trading qualification requirements for key staff; the lessening of the requirements in RTS 6 for automated executors; and the introduction of a recognised software vendor regime to reduce duplication and improve coordination between market participants that deploy algorithmic trading systems.Originality/valueTo the best of the author’s knowledge, the study represents the first qualitative examination of firms’ implementation of the algorithmic trading regime in the second Markets in Financial Instruments Directive 2014/65/EU.

Annual assessment of Echinococcus multilocularis surveillance reports submitted in 2022 in the context of Commission Delegated Regulation (EU) 2018/772.

This report is part of the Echinococcus multilocularis surveillance scientific reports which are presented annually by EFSA to the European Commission and are intended to assess the sampling strategy, data collection and detection methods used by Finland, Ireland, United Kingdom (Northern Ireland) and Norway in their respective surveillance programmes. The surveillance programmes of these four countries were evaluated by checking the information submitted by each of them and verifying that the technical requirements were fulfilled as laid down in Commission Delegated Regulation (EU) 2018/772 of 21 November 2017 supplementing Regulation (EU) No 576/2013 of the European Parliament and of the Council with regard to preventive health measures for the control of Echinococcus multilocularis infection in dogs, and repealing Delegated Regulation (EU) No 1152/2011. The information was divided into four different categories for assessment: the type and sensitivity of the detection method, the selection of the target population, the sampling strategy and the methodology. For each category, the main aspects that need to be considered in order to accomplish the technical requirements of the legislation were checked against compliance of several criteria. Three of the countries participating in this surveillance (Finland, Ireland and Norway (mainland)) succeeded in the fulfilment of the technical legal requirements foreseen in Commission Delegated Regulation (EU) 2018/772 concerning these four different categories. United Kingdom (Northern Ireland) fulfils those requirements, only assuming a diagnostic test sensitivity value of 0.99 (value provided by the national reference laboratory, higher than the conservative sensitivity value suggested by EFSA, i.e. 0.78). None of the four countries recorded positive samples in the 12-month reporting period.

STATE REGULATION OF INTERNET BANKING IN EUROPEAN COUNTRIES

The purpose of the study. The purpose of the article is to analyze the state of state regulation of Internet banking in European countries. The subject of the study is the legislation and trends of state regulation of online banking in European countries. The research methodology is based on a comparative analysis of legislation regulating online banking in the EU countries on the example of Switzerland and the UK. The main methods of research are comparative legal analysis, statistical analysis of the development of online banking in the EU countries. Conclusion. The growth of technological innovations in the financial sector and active user demand for financial and technological services have led to the need to develop a regulatory framework for Internet banking in European countries. As a result, the EU seeks to create a single financial space that unites providers and users of Internet banking, so it is constantly improving the regulatory framework. The article defines that the key documents at the EU level for state regulation of online banking are the EU Payment Services Directives (PSD1 2007/64, PSD2 2015/2366, the Reviewed Payment Services Directive PSD2 2021/1230). The main prerequisites for the adoption of the Directive were to create a level playing field for payment service providers, protect consumer rights and increase the provision of payment services by non-banking institutions. It is determined that Directive PSD2 2015/2366 updated the existing legal framework for payment services in the EU and introduced increased requirements for transparency and security. The updated Payment Services Directive PSD2 2021/1230 harmonises business rules for all electronic payment service providers across the EU and creates a tiered authorization regime for non-bank payment service providers such as payment institutions. Commission Delegated Regulation (EU) 2018/389 came into force on September 14, 2019, defining mechanisms for electronic payment transactions and online banking to ensure higher levels of security. The state regulation of online banking is considered on the examples of Great Britain and Switzerland. The Swiss financial sector is one of the most competitive in the world and a leader in cross-border wealth management. It offers a first-class environment for technological innovation and its regulatory system is internationally recognised as exemplary.

Does the deployment of algorithms combined with direct electronic access increase conduct risk? Evidence from the LME

PurposeThe purpose of this paper is to examine the effectiveness of two regulatory initiatives in developing awareness of conduct risk associated with algorithmic and direct-electronic access (DEA) trading at broker-dealers: the UK Financial Conduct Authority’s algorithmic trading compliance in the wholesale markets and Commission Delegated Regulation 2017/589 (CDR 589) to the second Markets in Financial Instruments Directive.Design/methodology/approachA qualitative examination of 15 semi-structured interviews with representatives of London Metal Exchange member firms, their clients and regulators.FindingsThis paper finds that the key conduct related messages in algorithmic trading compliance in the wholesale markets may not yet be fully embedded at broker–dealers. This is because of a perceived simplicity of the algorithms deployed by broker dealers or, alternatively, a lack of reflection on their impact. Conversely, a concern exists that clients’ deployment of algorithms on DEA channels provided by broker–dealers increase conduct risk. However, the threat of harm posed by clients is not envisaged in current definitions of conduct risk. Accordingly, CDR 2017/589 does not currently require firms to evaluate clients’ awareness of it.Research limitations/implicationsThis study’s findings are limited to the insights provided by 15 participants.Originality/valueThis paper contributes to existing research by deepening understanding of conduct risk arising from algorithmic trading and DEA. To account for the potential harm arising from clients’ activities, this paper proposes a revision to Miles’s definition of conduct risk. This is complemented by a proposed amendment to CDR 2017/589 to require evaluation of clients’ understanding of conduct risk.

Assessment of Regulatory Compliance Testing for Vitamin D in Infant Formula-Impact of Delegated Regulation (EU) 2019/828.

Since the publication of Standard Method Performance Requirements (SMPR®) for vitamin D in infant formula (SMPR 2011.004) by AOAC INTERNATIONAL, revised vitamin D limits have been recommended by the European Food Safety Authority (EFSA) for infant formula and adopted in Commission Delegated Regulation (EU) 2019/828. The vitamin D range introduced, 2-2.5 μg/100 kcal, is significantly narrower than previous limits specified by Codex Standard 72-1981 and requires lower method reproducibility metrics to adequately assess regulatory compliance. The narrower limits for vitamin D present a significant challenge for current-generation reference analytical methods that comply with SMPR 2011.004. We evaluate the impact of Delegated Regulation (EU) 2019/828 on the demonstrated performance of AOAC Method 2016.05/ISO 20636:2018 to assess the likelihood that vitamin D results produced by the method would be found outside the EU limits when testing infant formula that is compliant as manufactured. AOAC Method 2016.05/ISO 20636:2018, specifically data generated during multi-laboratory study, was used as a basis for statistical evaluation of the impact of the narrower EU vitamin D limits. The review of AOAC Method 2016.05/ISO 20636:2018 method performance against the vitamin D regulatory range introduced in (EU) 2019/828 indicates methods capable of performing in alignment with SMPR 2011.004 are likely to produce results that fail to meet EU requirements. Our assessment illustrates the high probability that a well-manufactured product with vitamin D levels within the EU regulatory range would fail to meet the regulatory requirements due to analytical method variability when tested using fit-for-purpose methods. Further, required method performance cannot be expected with the future development of new methods. To avoid this, consideration should be given to aligning proposed regulatory limits with method performance metrics of current-generation compendial methods. Current, state-of-the-art methods cannot consistently verify infant formula product compliance for vitamin D in accordance with (EU) 2019/828.

Flashing Lights, Dark Shadows, and Future Prospects of the Current European Legislation for a Better Traceability and Animal Health Requirements for Movements of Small Animal Germinal Products.

Recently, there has been an increasing movement of germinal products of dogs (Canis lupus familiaris) and cats (Felis silvestris catus) between the Member States. Therefore, Europe laid down and harmonized rules on the marking of straws and other packages containing germinal products [Commission Delegated Regulation (EU) 2020/686]. Given that germinal products' movement may increase the risk of infectious disease spread, requirements regarding animal health have been revised focusing on control of rabies and echinococcosis, although there are new emerging diseases that may require, even locally, specific requirements. For this reason, veterinarians, operators, and official veterinarians are involved in different phases of the process. Because non-veterinary operators can operate in all phases, they should have a limited role in collecting germinal products, especially for feline species. Veterinarians, instead, should have a main role in the health evaluation of donors, in collecting germ cells with medical techniques and in depositing sperm and embryos with endoscopic or surgical methods. The official veterinarians are the main ones responsible for the application of the rules. This paper aims to provide an overview of the European legislative framework regarding the newly delegated regulation on germinal products in small animals (dogs and cats), highlighting some of the benefits and critical aspects regarding its functioning.

Nutritional safety and suitability of a specific protein hydrolysate derived from whey protein concentrate and used in an infant and follow-on formula manufactured from hydrolysed protein by HIPP-Werk Georg Hipp OHG (dossier submitted by meyer.science GmbH).

The European Commission asked EFSA to deliver an opinion on the nutritional safety and suitability of a specific protein hydrolysate. It is derived from whey protein concentrate and used in infant and follow‐on formula by HIPP‐Werk Georg Hipp OHG. The dossier that was submitted to the European Commission aimed at requesting an amendment of Regulation (EU) 2016/127 with respect to the protein sources that may be used in infant and/or follow‐on formula. This opinion does not cover the assessment of the safety of the food enzymes used in the manufacture of the protein hydrolysate. The protein hydrolysate under evaluation is sufficiently characterised with respect to the fraction of the hydrolysed protein. In the pertinent intervention study provided, an infant formula manufactured from the protein hydrolysate with a protein content of 1.9 g/100 kcal and consumed as the sole source of nutrition by infants for 3 months led to growth equivalent to a formula manufactured from intact cow’s milk protein with the same protein content. No experimental data have been provided on the nutritional safety and suitability of this protein source in follow‐on formula. However, given that it is consumed with complementary foods and the protein source is considered nutritionally safe and suitable in an infant formula that is the sole source of nutrition of infants, the Panel considers that the protein hydrolysate is also a nutritionally safe and suitable protein source for use in follow‐on formula. The Panel concludes that the protein hydrolysate under evaluation is a nutritionally safe and suitable protein source for use in infant and follow‐on formula, as long as the formula in which it is used contains a minimum of 1.9 g/100 kcal protein and complies with the compositional criteria of Commission Delegated Regulation (EU) 2016/127 and the amino acid pattern in its Annex IIIA.

ДОСЛІДЖЕННЯ СТАНУ ТА ПЕРСПЕКТИВ ОНОВЛЕННЯ ЗАКОНОДАВСТВА УКРАЇНИ В СЕКТОРІ СІЛЬСЬКОГОСПОДАРСЬКИХ І ЛІСОГОСПОДАРСЬКИХ ТРАНСПОРТНИХ ЗАСОБІВ

The purpose of research is to substantiate the provisions regarding the further updating and improvement of the type approval system of agricultural and forestry vehicles and their components based on actual acts of the European Union (hereinafter - EU) [Regulation (EU) 167/2013, 2013, Commission Delegated Regulation (EU) 2015/208, 2015; Commission Delegated Regulation (EU) 2015/68, 2015; Commission Delegated Regulation (EU) No. 1322/2014, 2014; Commission Implementing Regulation (EU) 2015/504, 2015; Commission Delegated Regulation (EU) 2018/985, 2018].