(1)

On 5 March 2014, the Council adopted Regulation (EU) No 208/2014.

(2)

On the basis of a review by the Council, the entries for four persons against whom the application of restrictive measures expired on 6 September 2022, and the information regarding their rights of defence and their right to effective judicial protection, should be deleted from Annex I to Regulation (EU) No 208/2014.

(3)

Regulation (EU) No 208/2014 should therefore be amended accordingly,

(1)

On 18 January 2016, the Council adopted Regulation (EU) 2016/44.

(2)

On 18 July 2022, the United Nations Security Council (‘UNSC’) Committee established pursuant to UNSC Resolution 1970 (2011) updated the information relating to one person subject to restrictive measures.

(3)

Annex II to Regulation (EU) 2016/44 should therefore be amended accordingly,

(1)

On 30 August 2017, the Council adopted Regulation (EU) 2017/1509.

(2)

On 26 July 2022, the United Nations Security Council (‘UNSC’) Committee established pursuant to UNSC Resolution 1718 (2006) updated the information relating to 20 persons and 24 entities subject to restrictive measures.

(3)

Annex XIII to Regulation (EU) 2017/1509 should therefore be amended accordingly,

(1)

Council Directive 2006/112/EC (2), as amended by Directive (EU) 2020/284 (3), introduces reporting obligations for payment service providers from 1 January 2024. From then on, payment service providers who are established or provide payment services in the European Union are to keep certain records of cross-border payments originating from payers within Member States and certain information of the payees, and transmit those records to the Member States for the fight against value added tax (VAT) fraud.

(2)

Pursuant to Regulation (EU) No 904/2010, as amended by Regulation (EU) 2020/283 (4), Member States are to transmit those records to a central electronic system of payment information (‘CESOP’), which is to be developed, maintained, hosted and technically managed by the Commission.

(3)

To ensure the proper functioning of CESOP, and pursuant to Article 24e, point (a), of Regulation (EU) No 904/2010, it is necessary to adopt the technical measures for establishing CESOP. Those measures should provide for the necessary CESOP functionalities for the development of CESOP’s capabilities as described in Article 24c of Regulation (EU) No 904/2010. The measures should also ensure a high level of user-friendliness by providing search and visualisation tools in CESOP. In addition, CESOP should facilitate exchanges of information between Eurofisc liaison officials by allowing them to quickly and securely exchange information on VAT fraud directly in CESOP. The measures that the Commission should take to maintain CESOP after it becomes operational should also be laid down in order to ensure the operational quality standards of CESOP’s IT infrastructure and its functionalities, and that the required updates are made when needed to handle the system’s incidents between the Commission and Member States.

(4)

While Member States, as controllers of CESOP, are responsible for its management, the Commission has a series of responsibilities limited to the technical management of CESOP as its host and processor, pursuant to Article 24e, point (b), of Regulation (EU) No 904/2010. These should include the technical tasks necessary for the daily administration of CESOP such as keeping records of the Eurofisc liaison official accessing CESOP, keeping records of the payment service providers which transmitted data to Member States, establishing appropriate organisational security measures for CESOP, as well as providing the necessary training and support for Eurofisc liaison officials to use CESOP effectively.

(5)

Pursuant to Article 24b(1), point (b), of Regulation (EU) No 904/2010, Member States are to send data to CESOP in a common format. The data elements to be reported by payment service providers in the format of an XML document should be set out. In order to ensure the overall operability between national electronic systems and CESOP pursuant to Article 24b(3) of Regulation (EU) No 904/2010, Member States should check that the data transmitted by payment service providers includes the compulsory and syntactically correct data elements pursuant to Article 243d of Directive 2006/112/EC, as CESOP can only operate if the mandatory data is correctly logged into CESOP.

(6)

Member States should designate the Eurofisc liaison officials who will have access to CESOP and inform the Commission of their decision. In that regard, the Commission should provide those officials with a unique identifier to access CESOP and maintain a list of all Eurofisc liaison officials who have access to CESOP based on the information received from Member States.

(7)

Pursuant to Article 24e, point (g), of Regulation (EU) No 904/2010, the Commission is to establish procedures to ensure that appropriate technical and organisational security measures for the development and operation of CESOP are in place. Several security aspects of CESOP’s central components of also depend on the implementation of national security measures, such as measures to control the safety of the data transmitted and measures to ensure that only the Eurofisc liaison official with a valid unique identifier may access CESOP. Therefore, Member States should provide the Commission with information on their own security measures. The Member States and the Commission should keep each other informed of the security measures taken and of the need of any upgrade to those measures.

(8)

The processing of personal data under this Regulation as well as the responsibilities of Member States and the Commission is subject to the rules laid down in Regulation (EU) 2016/679 of the European Parliament and of the Council (5) and in Regulation (EU) 2018/1725 of the European Parliament and of the Council (6). Pursuant to Article 24e, point (h), of Regulation (EU) No 904/2010, the roles and responsibilities of Member States and the Commission regarding controllership of CESOP should be laid down. Member States should jointly be considered as controllers of CESOP as they decide on the means of processing and use of the data in CESOP. The Commission should be considered as processor as it acts on behalf of Member States in performing all its tasks.

(9)

This Regulation should only apply from 1 January 2024 in order to align it with the application of Regulation (EU) 2020/283 and Directive (EU) 2020/284.

(10)

The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered an opinion on 2 February 2022.

(11)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Administrative Cooperation,

(1)

On 16 July 2012, the Council adopted Decision 2012/392/CFSP (1) establishing a European Union CSDP mission in Niger to support the capacity building of the Nigerien security actors to fight terrorism and organised crime (EUCAP Sahel Niger).

(2)

On 7 September 2020, the Council adopted Decision (CFSP) 2020/1254 (2) and extended the Mission until 30 September 2022.

(3)

On 15 June 2022, the Political and Security Committee (PSC) examined the Strategic Review of the Mission and agreed to extend EUCAP Sahel Niger until 30 September 2024. On 28 June 2022, when closing the Strategic Review of the Mission, PSC furthermore agreed inter alia that the Mission should be able to exchange EU classified information with the Union Justice and Home Affairs agencies, in the framework of its mandate.

(4)

Decision 2012/392/CFSP should be amended accordingly.

(5)

EUCAP Sahel Niger will be conducted in the context of a situation which may deteriorate and could impede the achievement of the objectives of the Union’s external action as set out in Article 21 of the Treaty on European Union,

(1)

Restrictive measures adopted by the Council on the basis of Article 29 of the Treaty on European Union as well as of Article 215 of the Treaty on the Functioning of the European Union are an essential foreign policy tool for the Union’s external action.

(2)

The wide dissemination of, and easy access to, information on restrictive measures in force in the Union as well as information exchange between the Member States, stakeholders and the Commission are an essential condition of their efficacy.

(3)

Russia’s war of aggression against Ukraine has shown the urgent need to launch an action to better enable Member States and operators to implement the restrictive measures adopted since 24 February 2022. Increased demands on effective implementation of restrictive measures, new requirements set by the unprecedented scope and nature of restrictive measures, and the need for secure communications and close cooperation between Member States, stakeholders and the Commission for their implementation require new or improved and more secure information technology tools.

(4)

An operational action under the common foreign and security policy should support the development of the required applications and databases as a matter of urgency,

(1)

On 5 March 2014, the Council adopted Decision 2014/119/CFSP (1).

(2)

On the basis of a review by the Council, the entries for four persons against whom the application of restrictive measures expired on 6 September 2022, and the information regarding their rights of defence and their right to effective judicial protection, should be deleted from the Annex to Decision 2014/119/CFSP.

(3)

Decision 2014/119/CFSP should therefore be amended accordingly,

(1)

On 4 May 2020, the Council adopted Decision (CFSP) 2020/610 (1), which provided for an extension of the validity of the national permits of certain Palestinians for entry into, and stay in, the territory of the Member States referred to in Council Common Position 2002/400/CFSP (2) for a further period of 24 months.

(2)

On the basis of an evaluation of the application of Common Position 2002/400/CFSP, the Council considers it appropriate that the validity of those permits be extended for a further period of 24 months,

(1)

On 31 July 2015, the Council adopted Decision (CFSP) 2015/1333.

(2)

On 18 July 2022, the United Nations Security Council (‘UNSC’) Committee established pursuant to UNSC Resolution 1970 (2011) updated the information relating to one person subject to restrictive measures.

(3)

Annexes I and III to Decision (CFSP) 2015/1333 should therefore be amended accordingly,

(1)

On 27 May 2016, the Council adopted Decision (CFSP) 2016/849.

(2)

On 26 July 2022, the United Nations Security Council (‘UNSC’) Committee established pursuant to UNSC Resolution 1718 (2006) updated the information relating to 20 persons and 24 entities subject to restrictive measures.

(3)

Annex I to Decision (CFSP) 2016/849 should therefore be amended accordingly,

(1)

Commission Decision (EU) 2021/2313 (3) granted, in respect of certain Member States, relief from import duties and exemption of value added tax (‘VAT’) on importation of goods needed to combat the effects of the COVID-19 outbreak, from 1 January 2022 until 30 June 2022.

(2)

On 15 June 2022, the Commission consulted the Member States on whether an extension of the validity of the measures laid down in that Decision was necessary. Belgium, Latvia, Austria, Portugal and Slovenia (‘the requesting Member States’) submitted requests to that effect on 21 June 2022.

(3)

The imports made to the requesting Member States under Decision (EU) 2021/2313 have been beneficial in providing State organisations or other organisations that have been approved by the national competent authorities access to needed medicines, medical equipment and personal protective equipment, for which a shortage existed. Trade statistics for such goods indicate that the related importations are on a downward trend, but may fluctuate following new demands of goods needed to combat the COVID-19 pandemic. Despite the ongoing vaccination in the Union and a number of measures taken to prevent the spread of the virus, the number of COVID-19 infections in the requesting Member States still poses public health risks. As shortages of goods needed to combat the COVID-19 pandemic are still reported in those Member States, it is appropriate to grant a relief for import duties chargeable on goods imported for the purposes specified in Article 74 of Regulation (EC) No 1186/2009 and an exemption for VAT chargeable on goods imported for the purposes specified in Article 51 of Directive 2009/132/EC.

(4)

The requesting Member States should inform the Commission of the nature and quantities of the various goods admitted free of import duties and VAT with a view to combatting the effects of the COVID-19 outbreak, of the organisations they have approved for the distribution or making available of those goods and of the measures taken to prevent the goods from being used for purposes other than to combat the effects of that outbreak.

(5)

Taking into consideration the challenges that the requesting Member States envisage to face, relief of import duties and exemption of VAT should be granted in respect of importations made from 1 July 2022. The relief should remain in place until 31 December 2022.

(6)

On 22 July 2022, the Member States were consulted in accordance with Article 76, first paragraph, of Regulation (EC) No 1186/2009 and Article 53, first paragraph, of Directive 2009/132/EC,

(1)

A request for registration of a European citizens’ initiative entitled ‘Every European house equipped with 1 kW photovoltaic and 0,6 kW wind turbines using EU funding through the municipalities alone’ was submitted to the Commission on 11 July 2022.

(2)

The objectives of the initiative are expressed by the organisers as follows: ‘(1) to reduce the CO2 footprint of each household; (2) accountability of the municipalities, distributors and suppliers of energy, limiting migration between suppliers in the green zone with professional training for at least one municipality employee in environmental matters, using only EU equipment; (3) development of green energy sources in the most isolated villages and at the end of networks which would otherwise require consolidation investments funded by distributors, energy suppliers or territorial administrative units; (4) to change the public perception that green energy is expensive and to educate the public to consume at least 1 kW of solar energy during the day in order to reduce bills. We say stop to the energy war, we prepare local turbine pump systems of up to 400 kW, drip irrigation systems and hydrogen generators for compact energy zones. A major step for competitiveness in the EU.’

(3)

An annex to the initiative provides further details on the subject matter, objectives and background to the initiative, setting out and detailing the reasons to support it. The organisers claim that the money not used for resilience, cohesion and regional development could serve to fund, through territorial administrative units, 600 million photovoltaic panels and 197 000 megawatt green energy in approximately 197 million households across the Union for an estimated cost of EUR 750 billion, laying the foundations of the ‘green European energy union’.

(4)

As regards the call for action to install photovoltaic panels and wind turbines to supply households with green energy with a view to reducing their CO2 footprint, the Commission has the power to present proposals for legal acts creating obligations to equip new or existing buildings with renewable energy installations and seeking to speed-up permitting procedures for renewable energy projects on the basis of Article 194(2) of the Treaty.

(5)

Inasmuch as the initiative calls for its objectives to be achieved with the contribution of Union funds, the Recovery and Resilience Facility as well as the Just Transition Fund, InvestEU, based on Article 173 and/or Article 175 of the Treaty, and the proposed new Social Climate Fund, based on Article 91(1), point (d), Article 192(1) and Article 194(1), point (c), all provide for significant investments into the green transition.

(6)

For those reasons, none of the parts of the initiative manifestly fall outside the framework of the Commission’s powers to submit a proposal for a legal act of the Union for the purpose of implementing the Treaties.

(7)

That conclusion is without prejudice to the assessment of whether the concrete substantive conditions required for the Commission to act, including compliance with the principles of proportionality and subsidiarity, and compatibility with fundamental rights, would be met in this case.

(8)

The group of organisers has provided appropriate evidence that it fulfils the requirements laid down in Article 5(1) and (2) of Regulation (EU) 2019/788 and has designated the contact persons in accordance with Article 5(3), first subparagraph, of that Regulation.

(9)

The initiative is not manifestly abusive, frivolous or vexatious, nor is it manifestly contrary to the values of the Union as set out in Article 2 of the Treaty on European Union and rights enshrined in the Charter of Fundamental Rights of the European Union.

(10)

The initiative entitled ‘Every European house equipped with 1 kW photovoltaic and 0,6 kW wind turbines using EU funding through the municipalities alone’ should therefore be registered.

(11)

The conclusion that the conditions for registration under Article 6(3) of Regulation (EU) 2019/788 are fulfilled does not imply that the Commission in any way confirms the factual correctness of the content of the initiative, which is the sole responsibility of the group of organisers of the initiative. The content of the initiative only expresses the views of the group of organisers, and can in no way be taken to reflect the views of the Commission,

(1)

A request for registration of a European citizens’ initiative entitled ‘Protect the EU’s Rural Heritage, Food Security and Supply’ was submitted to the Commission on 13 July 2022.

(2)

The objectives of the initiative are expressed by the organisers as follows: ‘Europe’s rural regions are losing their heritage, industries, populations, and values – threatening food security and supply across the EU. To preserve what makes these regions unique for future generations and ensure the longevity of the EU’s food-producing communities, we need a renewed EU commitment to the promotion of regional heritage, rural sustainable growth and rising living standards. This European Citizens’ Initiative asks the EU to modernise its rural commitments to take into consideration the need for greater food security, supply of agricultural materials and protection for the rural way of life – its people, their values and livelihoods.’

(3)

An annex to the initiative provides further details on the subject matter, objectives and background to the initiative, by setting out and detailing the reasons to support it. The organisers claim that ‘rural sectors and those that work them face increasing pressure and diminishing incentives to continue, which, if, not addressed, will lead to the extinction of some of Europe’s most foundational communities and values’. They request the Commission to submit a proposal, within the competences conferred on the Union by the Treaties, to strengthen and preserve regional heritages and industries throughout the Union in order to boost rural growth and promote rural job practices and activities. They further ask for recognition of food security and supply, such as fertiliser and biogas materials, to maintain a robust regional food supply in the Union. They invite the Commission to include the promotion of rural heritage and the recognition of food security and supply in the European Agricultural Fund for Rural Development and they mention the need to increase the scope of the long-term vision for the Union’s rural areas up to 2040, the Rural Pact as well as the EU Rural Action Plan (2).

(4)

In line with the objectives of the common agricultural policy (CAP) established by Article 39 of the Treaty, the CAP strategic plans Regulation (3) pursues the general objectives of fostering a smart, competitive, resilient and diversified agricultural sector ensuring long-term food security, supporting and strengthen environmental protection and strengthening the socioeconomic fabric of rural areas (4). To the extent that the initiative’s objective of protection of the Union’s rural heritage, food security and supply is not covered by Regulation (EU) 2021/2115, the Commission has the power to present a proposal for a legal act on the basis of Article 42 and Article 43(2) of the Treaty.

(5)

For those reasons, none of the parts of the initiative manifestly fall outside the framework of the Commission’s powers to submit a proposal for a legal act of the Union for the purpose of implementing the Treaties.

(6)

That conclusion is without prejudice to the assessment of whether the concrete substantive conditions required for the Commission to act, including compliance with the principles of proportionality and subsidiarity and compatibility with fundamental rights, would be met in this case.

(7)

The group of organisers has provided appropriate evidence that it fulfils the requirements laid down in Article 5(1) and (2) of Regulation (EU) 2019/788 and has designated the contact persons in accordance with Article 5(3), first subparagraph, of that Regulation.

(8)

The initiative is not manifestly abusive, frivolous or vexatious, nor is it manifestly contrary to the values of the Union as set out in Article 2 of the Treaty on European Union and rights enshrined in the Charter of Fundamental Rights of the European Union.

(9)

The initiative entitled ‘Protect the EU’s Rural Heritage, Food Security and Supply’ should therefore be registered.

(10)

The conclusion that the conditions for registration under Article 6(3) of Regulation (EU) 2019/788 are fulfilled does not imply that the Commission in any way confirms the factual correctness of the content of the initiative, which is the sole responsibility of the group of organisers of the initiative. The content of the initiative only expresses the views of the group of organisers, and can in no way be taken to reflect the views of the Commission,

(1)

Annex I to Regulation (EU) No 528/2012 contains active substances which have a more favourable environmental or human or animal health profile. Products containing these active substances may therefore be authorised under a simplified procedure. Nitrogen is included in Annex I to Regulation (EU) No 528/2012, subject to the restriction that it is used in limited quantities in ready-for-use canisters.

(2)

Pursuant to Article 86 of Regulation (EU) No 528/2012, nitrogen is approved as active substance for use in biocidal products of product-type 18, insecticides (2). Biocidal products consisting of nitrogen as approved are authorised in several Member States and are supplied in gas cylinders (3).

(3)

Nitrogen can also be generated in situ from ambient air. In situ generated nitrogen is currently not approved for use in the Union and it is neither listed in Annex I to Regulation (EU) No 528/2012, nor inserted in the list of active substances included in the review programme of existing active substances in biocidal products in Annex II to Commission Delegated Regulation (EU) No 1062/2014 (4).

(4)

Pursuant to Article 55(3) of Regulation (EU) No 528/2012, on 5 April 2022 Finland submitted to the Commission an application for derogation from Article 19(1)(a) of that Regulation asking to allow it to authorise biocidal products consisting of nitrogen generated in situ from ambient air for the protection of cultural heritage (‘the application’).

(5)

Cultural heritage can be damaged by a wide range of harmful organisms, from insects to microorganisms. The presence of those organisms not only can lead to the loss of the cultural good itself, but also poses the risk of those harmful organisms being spread to other objects nearby. Without an appropriate treatment, objects could be irremediably damaged, putting the cultural heritage at serious risk.

(6)

In situ generated nitrogen is used to create a controlled atmosphere with a very low concentration of oxygen (anoxia) in permanent or temporary sealed treatment tents or chambers for the control of harmful organisms on cultural heritage objects. Nitrogen is separated from the ambient air and is pumped into the treatment tent or chamber, where the nitrogen content of the atmosphere is increased to 99 % approximately and consequently oxygen is almost completely depleted. The humidity of the nitrogen pumped into the treatment area is set according to the demands of the object to be treated. Harmful organisms cannot survive under the conditions created in the treatment tent or chamber.

(7)

According to the information submitted by Finland, the use of in situ generated nitrogen appears to be the only effective technique for the control of harmful organisms that can be used for all types of materials and combinations of materials present in cultural institutions without damaging them and is effective against all developmental stages of pests in cultural heritage.

(8)

The method of anoxia or modified or controlled atmosphere is listed in the standard EN 16790:2016 ‘Conservation of cultural heritage – Integrated pest management (IPM) for protection of cultural heritage’ and nitrogen is described in this standard as ‘most used’ for creating anoxia.

(9)

Other techniques for the control of harmful organisms are available, such as thermal shock techniques (high or low temperatures). In addition, biocidal products containing other active substances can be used for that purpose. However, according to Finland, each of those techniques has limitations in terms of damage that could occur to certain materials during treatment.

(10)

As stated in the application, other active substances are seldom used in cultural institutions due to their hazard profile. After treatment with those substances, the residues on the treated objects can be progressively released to the environment, which poses a risk to human health. Moreover, those substances may react with the materials of the heritage objects causing irreversible changes, especially of their surface.

(11)

According to the information in the application, the use of nitrogen in cylinders is not an appropriate alternative for cultural institutions, as it presents practical disadvantages. The limited quantities in cylinders require frequent transport and a separate storage facility. The treatment with nitrogen in cylinders would also generate high costs for the cultural institutions.

(12)

Requesting cultural institutions to use several techniques to control harmful organisms – each of them suitable for specific materials and objects – instead of using one technique already used and suitable to all materials, would involve additional costs for cultural institutions and make it more complicated for them to reach the objective of moving away from the use of more hazardous active substances in their IPM. In addition, the abandonment of facilities and equipment acquired for in situ generated nitrogen anoxia would represent a loss of previous investments.

(13)

Discussions related to a possible derogation pursuant to Article 55(3) of Regulation (EU) No 528/2012 for in situ generated nitrogen took place in several meetings (5) of the Commission expert group of Competent Authorities for Biocidal Products in 2019.

(14)

In addition, at the request of the Commission, following the first, similar application for derogation for products consisting of in situ generated nitrogen from Austria, the European Chemicals Agency conducted a public consultation on that application, allowing all interested parties to provide their views. The vast majority of the 1487 comments received were in favour of the derogation. Many contributors outlined the disadvantages of the alternative techniques available: thermal treatments may damage certain materials; the use of other active substances leaves toxic residues on artefacts that are progressively released to the environment; the use of nitrogen in cylinders does not allow the control of the relative humidity in the treatment area, which is needed for the treatment of some materials.

(15)

The inclusion of in situ generated nitrogen in Annex I of Regulation (EU) No 528/2012 would allow Member States to authorise products consisting of in situ generated nitrogen without the need for a derogation in accordance with Article 55(3) of that Regulation. Such an application has been submitted in March 2022. However, performing the evaluation of this application, including the substance into Annex I to Regulation (EU) No 528/2012 and obtaining product authorisations require time.

(16)

The application shows that no appropriate alternatives are available in Finland, since all the alternative techniques currently available present disadvantages either due to non-suitability for the treatment of all materials or practical disadvantages.

(17)

Based on all those arguments it is appropriate to conclude that in situ generated nitrogen is essential for the protection of cultural heritage in Finland and that no appropriate alternatives are available. Finland should therefore be allowed to authorise the making available on the market and use of biocidal products consisting of in situ generated nitrogen for the protection of cultural heritage.

(18)

The possible inclusion of in situ generated nitrogen into Annex I to Regulation (EU) No 528/2012 and the subsequent authorisation by Member States of products consisting of in situ generated nitrogen requires time. It is therefore appropriate to allow a derogation for a period that would allow the completion of the underlying procedures,

(1)

On 19 October 2015, the company Laboratoria Qualiphar N.V./S.A. (‘the applicant’) submitted to the competent authorities of several Member States, including France, an application for mutual recognition in parallel, in accordance with Article 34 of Regulation (EU) No 528/2012, of the biocidal product Mouskito Junior Lotion (‘the biocidal product’). The biocidal product is a ready-to-use product intended to protect human skin from insect bites and contains as active substance ethyl butylacetylaminopropionate (IR 3535). Belgium is the reference Member State responsible for the evaluation of the application as referred to in Article 34(1) of Regulation (EU) No 528/2012.

(2)

The claims of the applicant for the product were: protection in tropical climate areas against mosquitoes (Aedes aegypti, Culex quinquefasciatus, Anopheles gambiae) and in areas with temperate climate against mosquitoes (Aedes aegypti, Culex quinquefasciatus), flies (Stomoxys calcitrans), bees (Apis mellifera), wasps (Vespula vulgaris) and ticks (Ixodes ricinus).

(3)

On 19 June 2019, pursuant to Article 35(2) of Regulation (EU) No 528/2012, France referred objections to the coordination group, indicating that the biocidal product does not meet the conditions laid down in Article 19(1), point (b) (i), of that Regulation for the use against bees and wasps. The referral was discussed in the coordination group on 16 September 2019.

(4)

As no agreement was reached in the coordination group, on 7 November 2019 Belgium referred the unresolved objection to the Commission, pursuant to Article 36(1) of Regulation (EU) No 528/2012. Belgium provided the Commission with a detailed statement of the matter on which Member States were unable to reach agreement and the reasons for their disagreement. The statement was forwarded to the Member States concerned and to the applicant.

(5)

France disagrees with the reference Member State’s recommendation for authorisation of the use against wasps and bees. More specifically, France considers that efficacy for the specific use has not been demonstrated in the simulated-use test provided by the applicant, as the design of that test did not permit the determination of a complete protection time (2) and as the product was not applied on a human skin-like surface.

(6)

Belgium argues that the applicant has performed the tests required by the guidance existing at the time of the application submission and noted that for wasps and bees no established protocol exists. Belgium considers that a specific claim cannot be dismissed only because an established testing protocol does not exist and that therefore an expert judgement needs to be used. While acknowledging that no complete protection time was determined by the test provided by the applicant, Belgium concluded on the basis of expert judgement that the claim of repellence of bees and wasps was sufficiently supported.

(7)

On 17 December 2021, the Commission requested an opinion on that matter from the European Chemicals Agency (‘the Agency’) in accordance with Article 36(2) of Regulation (EU) No 528/2012. The Agency was requested to indicate (i) whether a determination of complete protection time is needed for the assessment of the efficacy against bees and wasps and whether the simulated-use test performed by the applicant allows the determination of a complete protection time, (ii) whether simulated-use tests need to be performed on a human skin-like surface and (iii) whether the performed simulated-use test generated data demonstrating that the biocidal product controls wasps and bees by repelling those organisms at the recommended dose and thereby support the claim ‘repels wasps and bees’.

(8)

On 2 March 2022, the Biocidal Products Committee of the Agency adopted its opinion (3).

(9)

According to the Agency, efficacy data relevant to the actual conditions of use are needed to substantiate the product claims. The protection time is a very important parameter, especially for products intended to be used against dangerous insects, also considering that bees and wasps stings are a real concern to vulnerable individuals due to allergic reactions to the venom.

(10)

The Agency acknowledges that there are no agreed efficacy test protocols or criteria for topical repellents against wasps and bees and considers that it is the applicant’s responsibility to provide efficacy data from studies designed to mimic the practical use situation in order to substantiate the claim.

(11)

The tests performed by the applicant were field trials conducted in orchards. The repellent efficacy was investigated using traps in the form of plastic bottles, filled with sugar solution and detergent to catch the target organisms. The surface of the traps was treated with the test product twice a day or remained untreated. According to the Agency, for repellents against bees and wasps the set-up of the test using traps with an attractant as test subject instead of humans could be acceptable, due in particular to ethical issues raised by exposure of humans to inevitable and painful bee and wasp stings. However, the data collected during the field trial performed by the applicant do not allow the establishment of the complete protection time.

(12)

The Agency also points out that the surface of the bottles used as traps, which is a non-porous material, is significantly different from any material simulating the properties of human skin, especially in terms of absorbance and odour, which may affect the efficacy of the repellent. The test design should mimic the practical in-use situation as much as possible, for instance it would be preferable to use an absorbent human skin-like surface or texture like animal skin, or any artificial porous material modified in a way to simulate human skin.

(13)

According to the Agency, the data submitted by the applicant from the field trials are in principle valid and could demonstrate the efficacy of products intended to be used as spatial or surface repellents and could substantiate a claim ‘repels wasps and bees’. However, the test provided is not relevant for the intended use, that is topical repellent against wasps and bees to be applied on human skin and thus used to protect individuals against insect bites/stings. The generated data should be relevant to this intended use. The treated surface of the traps in the test performed does not sufficiently mimic the practical use situation, therefore the test design cannot be considered suitable to demonstrate efficacy of the product for the claimed use.

(14)

Taking into account the opinion of the Agency, the Commission considers that the biocidal product does not meet the condition laid down in Article 19(1), point (b)(i), of Regulation (EU) No 528/2012 for the use of the product as repellent against wasps and bees.

(15)

The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Biocidal Products,

(1)

Regulation (EU) 2021/953 sets out the EU Digital COVID Certificate the purpose of which is to serve as a proof that a person has received a COVID-19 vaccine, a negative test result or has recovered from infection for the purpose of facilitating the holders’ exercise of their right to free movement during the COVID-19 pandemic.

(2)

In order for the EU Digital COVID Certificate to be operational throughout the Union, the Commission adopted Implementing Decision (EU) 2021/1073 (2) laying down technical specifications and rules to populate, securely issue and verify EU Digital COVID Certificates, ensure the protection of personal data, lay down the common structure of the unique certificate identifier and issue a valid, secure and interoperable barcode.

(3)

On 29 June 2022, the European Parliament and Council adopted Regulation (EU) 2022/1034 (3), which extends the period of application of Regulation (EU) 2021/953 on the EU Digital COVID Certificate until 30 June 2023. That extension ensures that the EU Digital COVID Certificate can continue to facilitate free movement during the COVID-19 pandemic, while pursuing a high level of public health protection. This is particularly relevant in the event that certain restrictions to free movement on grounds of public health are maintained or (re-)introduced, for example in response to the emergence and spread of new SARS-CoV-2 variants of concern.

(4)

To enlarge the scope of COVID-19 diagnostic tests that may be used for the issuance of an EU Digital COVID Certificate, the definition of rapid antigen tests set out in Article 2, point 5, of Regulation (EU) 2021/953 was amended by Regulation (EU) 2022/1034 to include laboratory-based antigenic assays. It is now possible for Member States to issue test certificates and, following the adoption of Commission Delegated Regulation (EU) 2022/256 (4), certificates of recovery on the basis of the antigen tests included in the EU common list of COVID-19 antigen tests, as agreed, and regularly updated, by the Health Security Committee and as meeting the established criteria.

(5)

Article 5(5) of Regulation (EU) 2021/953 was also amended by Regulation (EU) 2022/1034 in order to allow Member States to issue vaccination certificates to participants in clinical trials that have been approved by Member States’ ethical committees and competent authorities, regardless of whether the participant received the COVID-19 vaccine candidate or, to avoid undermining the studies, the dose administered to the control group. Pursuant to Article 3(11) of Regulation (EU) 2021/953, where necessary, the Commission is to ask the Health Security Committee, ECDC or EMA to issue guidance on the acceptance of COVID-19 vaccines undergoing clinical trials in the Member States.

(6)

In view of these amendments to Regulation (EU) 2021/953, in order to ensure the interoperability of the EU Digital COVID Certificate, the rules for populating the EU Digital COVID Certificate should be updated to reflect the possibility to use laboratory-based antigenic assays for test and recovery certificates and to issue vaccination certificates for participants in clinical trials.

(7)

Implementing Decision (EU) 2021/1073 should therefore be amended accordingly.

(8)

In the light of the need for rapid implementation of the amended technical specifications for the EU Digital COVID Certificate, this Decision should enter into force on the third day following that of its publication in the Official Journal of the European Union.

(9)

The measures provided for in this Decision are in accordance with the opinion of the Committee, established by Article 14 of Regulation (EU) 2021/953,

(1)

In accordance with Regulation (EU) No 305/2011, Technical Assessment Bodies are to use methods and criteria provided in European Assessment Documents, the references of which have been published in the Official Journal of the European Union, for assessing performance of construction products covered by those documents in relation to their essential characteristics.

(2)

In accordance with Article 19 of Regulation (EU) No 305/2011, following several requests by manufacturers for European Technical Assessments, the organisation of Technical Assessment Bodies has drawn up and adopted 10 European Assessment Documents and one correction.

(3)

The European Assessment Documents drawn up and adopted by the organisation of Technical Assessment Bodies relate to the following construction products:

(4)

The European Assessment Document with the reference number 360001-01-0803 relating to ventilation system made of mineral wool with facings on outside and inside, the reference of which is published by Commission Implementing Decision (EU) 2019/450 (2) contains an error. It is therefore necessary to add a clarification that European Assessment Document with the reference number 360001-01-0803 supersedes the previous version of the European Assessment Document with the reference number 360001-00-0803.

(5)

The European Assessment Documents drawn up and adopted by the organisation of Technical Assessment Bodies satisfy the demands to be met in relation to the basic requirements for construction works set out in Annex I to Regulation (EU) No 305/2011. It is therefore appropriate to publish the references of those European Assessment Documents in the Official Journal of the European Union.

(6)

The list of references of European Assessment Documents is published by Implementing Decision (EU) 2019/450. For reasons of clarity, references of new European Assessment Documents should be added to that list.

(7)

Implementing Decision (EU) 2019/450 should therefore be amended accordingly.

(8)

In order to enable the use of the European Assessment Documents as early as possible, this Decision should enter into force on the day of its publication,