(1)

Commission Regulation (EU) No 139/2014 (2) lays down requirements and administrative procedures related to aerodromes, including provisions addressing the surface movement guidance and control system and low-visibility operations at aerodromes.

(2)

In order to align those provisions with Annexes 6 and 14 to the Convention on International Civil Aviation and Doc 9365 of the International Civil Aviation Organization (‘ICAO’) it is necessary to lay down rules on the implementation of all-weather operations at aerodromes, by ensuring the availability of the appropriate visual and non-visual aids as well as other aerodrome equipment, the availability of the required information, and the implementation of appropriate procedures.

(3)

Annex I (Definitions) to Regulation (EU) No 139/2014 should be amended as regards to the definitions of decision altitude, instrument runway, low visibility operations, low visibility procedures, low visibility take-off, operation with operational credits and Type B instrument approach operation.

(4)

Annex III (Part-ADR.OR) to Regulation (EU) No 139/2014 lays down organisation requirements for aerodrome operators. That Annex has become outdated as regards the regulatory framework regarding visual and non-visual aids, notably as regards meteorological equipment and should therefore be amended to include specific requirements as regards the availability and maintenance of visual and non-visual aids and any other equipment necessary to support all-weather operations.

(5)

Annex IV (Part-ADR.OPS) to Regulation (EU) No 139/2014 lays down the requirements for the operation of aerodromes. That Annex should be amended to include specific operational procedures applicable to the aerodrome operator that address the surface movement guidance and control system and low-visibility operations at aerodromes.

(6)

Regulation (EU) No 139/2014 should therefore be amended accordingly.

(7)

Pursuant to Article 75(2), points (b) and (c) and Article 76(1) of Regulation (EU) 2018/1139 the European Union Aviation Safety Agency prepared and submitted to the Commission Opinion No 02/2021 (3) as regards draft implementing rules.

(1)

Commission Delegated Regulation (EU) 2021/578 (2) sets out the requirements for the collection of data on the volume of sales and on the use of antimicrobial medicinal products in animals.

(2)

In order for Member States to be able to collect and report such data to the European Medicines Agency (‘the Agency’), the format of such data should be clearly defined.

(3)

The required format of the data should apply to the data collected for the antimicrobials referred to in Articles 1 to 4 of Delegated Regulation (EU) 2021/578 in order to have harmonised and comparable data. The required format of the data should equally apply to data collected on antimicrobials contained in medicated feed and intermediate products, in line with Article 4(4) of Regulation (EU) 2019/4 of the European Parliament and of the Council (3).

(4)

The format, which Member States are to use for reporting antimicrobial sales and use data to the Agency, should take into account specific data variables that need to be provided per product presentation in order to enable the Agency to calculate the quantity of antimicrobial active substances from veterinary medicinal products sold per Member State for use on its territory during the year of data collection. Those data variables should also enable the Agency to calculate the quantity of antimicrobial active substances from medicinal products used in designated animal species or categories per Member State on its territory during the year of data collection. Additional data variables should be provided by Member States to the Agency, per reporting year, in order to allow for an accurate analysis and interpretation of the data.

(5)

The Agency should provide the necessary supporting information to Member States in order to facilitate the harmonised calculation of the volume of sales and of the use of antimicrobials and to facilitate subsequent data validation by Member States before reporting to the Agency. Such supporting information is to be provided to Member States by the Agency through the web interface for collated data reporting referred to in Article 10 of Delegated Regulation (EU) 2021/578.

(6)

In addition, the Agency should minimise the efforts required by Member States to enter data in the web interface, by pre-filling data entry fields whenever data is already available from existing databases under the remit of the Agency. At the same time, in line with Article 6 of Delegated Regulation (EU) 2021/578, Member States remain responsible for the fulfilment of the data quality requirements with respect to the information provided on the antimicrobial medicinal products authorised at national level, including the accuracy of the information provided by the Agency in those pre-filled data entry fields.

(7)

To ensure that the data collected on the sales and the use of antimicrobials is comparable year-over-year within Member States and within the Union and that those data are adequately analysed, the format for reporting of the data should take into account the size of the animal population that is likely to be treated with antimicrobials. This should also facilitate the comparison of data reported at national level and at Union level with data available from non-Union countries and at global level. It is therefore important to define the format according to which the animal population data should be referred to. Any comparison of data across Member States should take into account the diversity of practices within the Union and the differences in national legal contexts.

(8)

The most appropriate format for the animal population data as regards terrestrial animals should be the number of living animals or the number of slaughtered animals, depending on the animals species or categories concerned, while the most appropriate format for the animal population data as regards farmed fish should be the produced biomass. However, in order to appropriately reflect each Member State’s animal population data in the context of the collection of data on the volume of sales and on the use of antimicrobials in animals, so that it can be effectively used by the Agency, the animal population data should be adjusted according to so-called denominators, such as the population correction unit or other denominators, as appropriate. Such adjustments are necessary for the Agency to identify trends in the volume of sales and the use of antimicrobials in animals and make relevant analyses.

(9)

This Regulation is necessary for the application of Regulation (EU) 2019/6, which applies from 28 January 2022. Therefore, and in accordance with Article 153(1) of Regulation (EU) 2019/6, this Regulation should apply from that same date.

(10)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Veterinary Medicinal Products referred to in Article 145 of Regulation (EU) 2019/6,

(1)

Semiconductors are essential to the functioning of our modern economy and society. Within the past year, the Union has witnessed unprecedented disruptions in their supply which have entailed serious delays and negative effects on important economic sectors and have led to delays to the repair and maintenance of essential products for critical sectors, such as medical and diagnostic equipment.

(2)

The current semiconductor shortage crisis and its ripple effects therefore render critical sectors such as health, transport, energy, defence, security and space under threat of being affected. The Union’s green and digital transition is at risk of delay.

(3)

Against that background, the Commission Proposal for a Regulation of the European Parliament and the Council establishing a framework of measures for strengthening Europe’s semiconductor ecosystem (Chips Act) (1) aims to address the Union’s resilience to disruptions in the semiconductor supply chain, to foster the development of capacities in advanced manufacturing, design and system integration as well as cutting-edge industrial manufacturing within the Union, to address the acute skills shortage, to increase qualified workforce and to contribute to creating a resilient and dynamic semiconductor ecosystem in the Union. The Union is committed to its strategic goal to reach at least 20 % of world production in value of cutting-edge, innovative and sustainable semiconductors by 2030, as set out in the Digital Decade Policy Programme (2).

(4)

This Recommendation accompanies the proposed Regulation as a tool with immediate effect to enable a rapid and coordinated Union response to the current shortage. To that end, it proposes to set up a coordination mechanism to discuss and decide on timely and proportionate crisis response measures.

(5)

In view of the structural deficiencies of the semiconductor supply chain, it additionally recommends measures to enable coordinated monitoring of the semiconductor value chain, focussing on risks that may disrupt, compromise or negatively affect the supply of semiconductors. Those measures should prepare and enable the permanent mechanism for monitoring of the semiconductor supply chain proposed under the Regulation.

(6)

The Commission has set up the European Semiconductor Expert Group, for the purpose of implementing this Recommendation. The European Semiconductor Expert Group will serve as a platform for coordination between Member States and provide advice and assistance to the Commission in the implementation of the forthcoming Regulation. The tasks of the European Semiconductor Expert Group shall be taken over by the European Semiconductor Board to be established in the Regulation.

(7)

The European Semiconductor Expert Group should facilitate rapid and effective information exchange between the Member States and the Commission on market developments that put Union supplies at tangible risk, and foster a uniform and coordinated crisis response.

(8)

As a first measure, Member States are recommended to request information from representative organisations of undertakings or, if necessary, from individual semiconductor and equipment manufacturers. This would increase the ability of the European Semiconductor Expert Group to identify and tailor potential crisis response measures. The data gathered should concern the production capability, production capacity and current primary disruptions and bottlenecks. Any collection or exchange of information should be in line with applicable rules on data sharing and confidentiality of information and data.

(9)

This Recommendation includes suggestions for crisis response measures that Member States are invited to discuss and consider to implement where relevant and proportionate.

(10)

If the assessment of the crisis at hand so requires, Member States could consider entering into a dialogue asking semiconductor manufacturers established in the Union to prioritise contracts with companies who supply products to critical sectors, with a view to ensure that these sectors continue to operate.

(11)

Furthermore, if relevant and appropriate according to the assessment of the crisis at hand, Member States may consider granting a mandate to the Commission to procure certain products on their behalf, in order to create a leverage effect through its purchasing power and to ensure the supply to critical sectors in the public interest.

(12)

Finally, Member States are encouraged to assess whether the Union should exercise surveillance over certain exports for securing supply to the internal market. If they find such protective measures appropriate, necessary and proportionate, they could discuss and request the Commission to assess whether the conditions for protective measures with regard to exports pursuant to Regulation (EU) 2015/479 of the European Parliament and of the Council (3) are fulfilled.

(13)

The recommended monitoring action should follow the principles of anticipation, coordination and preparedness with a view to establish an early warning system in order to prevent semiconductor crises and to strengthen the Union’s semiconductor ecosystem. To that end, Member States are asked to discuss in the European Semiconductor Expert Group appropriate early warning indicators to anticipate future shortages in the semiconductor supply chain.

(14)

Further in-depth assessment is needed as regards the risks that may disrupt, compromise or negatively affect the value chain, including on the origins and sources of supplies beyond the Union. Therefore, Member States are recommended to gather relevant information and cooperate with a view to enable the Commission to prepare a common risk assessment for the semiconductor value chain in the Union. Factors to be taken into account when preparing the risk assessments should be indicated.

(15)

The Commission sets out in the proposed Regulation a permanent and binding mechanism for a coordinated monitoring and crisis response, which builds upon the measures suggested in this Recommendation. Once the Regulation enters into force, this Recommendation may be repealed.