(1)

On 14 June 2017, Dow Europe GmbH (‘the applicant’) submitted an application to the European Chemicals Agency (‘the Agency’) in accordance with Article 43(1) of Regulation (EU) No 528/2012 for Union authorisation of a biocidal product family named ‘CMIT/MIT SOLVENT BASED’ of product-type 6, as described in Annex V to that Regulation, for preservation of aviation fuel, crude oil and middle distillate fuel, providing written confirmation that the competent authority of France had agreed to evaluate the application. The application was recorded under case number BC-NN032576-24 in the Register for Biocidal Products. On 16 April 2020, the applicant withdrew the application as regards use of ‘CMIT/MIT SOLVENT BASED’ in aviation fuels. On 31 October 2020, the application was transferred by the applicant to Nutrition & Biosciences Netherlands B.V.

(2)

The biocidal product family ‘CMIT/MIT SOLVENT BASED’ comprises products for preservation of de-watered crude oil and refined products (middle and light distillate fuels) containing 5-chloro-2-methylisothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one (‘C(M)IT/MIT’) as the active substance, which is included in the Union list of approved active substances referred to in Article 9(2) of Regulation (EU) No 528/2012.

(3)

On 28 August 2019, the evaluating competent authority submitted, in accordance with Article 44(1) of Regulation (EU) No 528/2012, the assessment report and the conclusions of its evaluation to the Agency.

(4)

On 7 April 2020, the Agency submitted an opinion (2), the draft summary of the biocidal product characteristics (‘SPC’) of ‘CMIT/MIT SOLVENT BASED’ and the final assessment report on the biocidal product family to the Commission in accordance with Article 44(3) of Regulation (EU) No 528/2012.

(5)

The opinion concludes that ‘CMIT/MIT SOLVENT BASED’ is a biocidal product family within the meaning of Article 3(1), point (s), of Regulation (EU) No 528/2012, that it is eligible for Union authorisation in accordance with Article 42(1) of that Regulation and that, subject to compliance with the draft SPC, it meets the conditions laid down in Article 19(1) and (6) of that Regulation. The opinion included a minority position expressed by the member appointed by Germany, which concluded that the use of ‘CMIT/MIT SOLVENT BASED’ as a preservative in fuels conflicts with the national legislation of that Member State (10th Federal Emission Control Ordinance §2 (1) and (2)), which forbids that fuels for on-road motor vehicles contain additives with chlorine or bromine compounds and which forbids the placing on the market of additives that contain chlorine or bromine as these compounds cause formation of dioxins during the fuel combustion.

(6)

On 15 January 2021, the Agency transmitted the draft SPC to the Commission in all the official languages of the Union in accordance with Article 44(4) of Regulation (EU) No 528/2012.

(7)

To address the concerns on dioxin formation expressed in the minority position to the opinion, on 24 July 2020, the Commission requested an opinion from the Agency under Article 75(1), point (g), of Regulation (EU) No 528/2012 to estimate the amount of formation of dioxins and the overall contribution to the emissions of dioxins due to the use of the biocidal product family ‘CMIT/MIT SOLVENT BASED’ in fuels used for road and water transport. The Commission also requested the Agency to clarify the level of the risks to the environment and human health due to the exposure to dioxins via the environment from the use of the biocidal product family ‘CMIT/MIT SOLVENT BASED’.

(8)

On 5 July 2021, the Agency submitted the requested opinion to the Commission (3) concluding that although the potential consequences of the use of C(M)IT/MIT as a preservative in oil and fuel cannot be neglected, it is not possible to draw any conclusions on the magnitude of the potential contribution of the use of C(M)IT/MIT in fuels with respect to dioxin exposure, nor on the potential consequences of chlorine additives such as C(M)IT/MIT in fuels on human health and on the environment.

(9)

The objectives of the Stockholm Convention on Persistent Organic Pollutants (‘Stockholm Convention’) (4) and Regulation (EU) 2019/1021 of the European Parliament and of the Council (5) are to protect human health and the environment from persistent organic pollutants (POPs), which include dioxins. The Commission considers that refusing the Union authorisation for the biocidal product family ‘CMIT/MIT SOLVENT BASED’ would not lead to a significant decrease of dioxin emissions compared to granting it, as the same or similar chlorine-containing additives are currently allowed to be placed on the market under transitional measures of Regulation (EU) No 528/2012 by the Member States or could be authorised under national authorisations granted in accordance with Regulation (EU) No 528/2012. Furthermore, as a consequence of the ambitions of the European Green Deal (6) and Regulation (EU) 2021/1119 of the European Parliament and of the Council (7) (the European Climate Law (8)) to achieve climate neutrality by 2050, the overall amount of fuel that may potentially be treated with the biocidal product family and combusted in motors or heating systems is expected to decline significantly in the coming decades. Consequently, the possible formation of dioxins associated with the use of the biocidal product family ‘CMIT/MIT SOLVENT BASED’ will decrease accordingly, thus contributing to achieve the objectives of the Stockholm Convention and Regulation (EU) 2019/1021.

(10)

On 16 November 2021, in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012, Denmark made a request to the Commission for the Union authorisation of the biocidal product family ‘CMIT/MIT SOLVENT BASED’ not to apply in its territory, based on the grounds provided in Article 37(1), points (a) and (c), of that Regulation, as the presence of halogenated organic compounds such as C(M)IT/MIT in fuel may result in the formation of dioxins during fuel combustion, alternatives for fuel preservation without halogenated compounds are available and preservatives for fuels are not used by refineries or at service stations in Denmark.

(11)

On 12 December 2021, Germany requested that the Commission adjusts the conditions of the Union authorisation of the biocidal product family ‘CMIT/MIT SOLVENT BASED’ in its territory in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012, based on the grounds referred to in Article 37(1) points (a) and (c), of that Regulation so as not to allow its use for the preservation of fuels for non-rail bound on-road motor vehicles, except for the purpose of research, development or analysis in line with national legislation as set out in the 10th Federal Emission Control Ordinance (9) in combination with the German Road Traffic Act (Straßenverkehrsgesetz) (10).

(12)

On 15 July 2022, in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012, Belgium made a request to the Commission for the Union authorisation of the biocidal product family ‘CMIT/MIT SOLVENT BASED’ not to apply in its territory, based on the grounds provided in Article 37(1), points (a) and (c), of that Regulation, as it considers that the presence of halogenated organic compounds such as C(M)IT/MIT in fuel may result in the formation of dioxins during fuel combustion, that the formation of dioxins should be minimised and, where feasible, fully eliminated in Belgium, and that alternatives for fuel preservation without halogenated compounds are available.

(13)

The Commission considers that the requests made by Germany to adjust the conditions and the requests made by Denmark and Belgium not to apply the Union authorisation of the biocidal product family ‘CMIT/MIT SOLVENT BASED’ in the respective territories of those Member States in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012 can be considered justified on the grounds of the protection of the environment and the protection of health and life of humans pursuant to Article 37(1), points (a) and (c), of that Regulation as the presence of halogenated organic compounds, such as C(M)IT/MIT, in fuel may result in the formation of dioxins during fuel combustion.

(14)

Therefore, the biocidal product family ‘CMIT/MIT SOLVENT BASED’ should not be authorised for use in Denmark and Belgium and should be not be used in Germany for the preservation of fuels for non-rail bound on-road motor vehicles, except for the purpose of research, development or analysis.

(15)

Therefore, the Commission concurs with the opinion of the Agency and considers it appropriate to grant a Union authorisation for ‘CMIT/MIT SOLVENT BASED’ with the adjustments for Germany, Denmark and Belgium requested in accordance with Article 44(5), second subparagraph, of Regulation (EU) No 528/2012.

(16)

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

(1)

The practical implementation of Regulation (EU) No 952/2013 (‘the Code’) in combination with Commission Implementing Regulation (EU) 2015/2447 (2) has shown that some amendments to that Implementing Regulation are needed to better tailor it to the needs of economic operators and customs authorities and to take into account the developments regarding the forthcoming deployment of releases 2 and 3 of the Import Control System (ICS2).

(2)

Article 36 of Implementing Regulation (EU) 2015/2447 provides for the use of the Customs Risk Management System for the exchange of risk-related information between Member States’ customs authorities and the Commission, and between customs authorities, and for the storage of such information. Following the deployment of the security and safety analytics in ICS2, it is necessary to amend that Article in order to also allow the Member States and the Commission to exchange specific information needed for pre-arrival security and safety risk analysis purposes using the ICS2.

(3)

Article 184 of Implementing Regulation (EU) 2015/2447 provides obligations for the submission of particulars of the entry summary declaration to customs authorities by persons other than the carrier. From the date set out in Part II of the Annex to Commission Implementing Decision (EU) 2019/2151 (3) for the deployment of release 2 of ICS2, the submission of entry summary declarations through the ICS2 system for goods entering the customs territory of the Union by air is to become obligatory. It should therefore be necessary to oblige the carrier to inform customs authorities when a third country postal operator does not provide him or her with the particulars required for the entry summary declaration.

(4)

Furthermore, from the date set out in Part II of the Annex to Implementing Decision (EU) 2019/2151 for the deployment of release 3 of ICS2, the submission of entry summary declarations through the ICS2 system for goods entering the customs territory of the Union by rail is to become obligatory. It should therefore be necessary to oblige the carrier to inform the customs authorities if any person issuing a consignment note for goods entering the customs territory of the Union by rail does not provide him or her with the particulars required for the entry summary declaration, and to oblige the person issuing the consignment note to inform the other parties to the transport contract of that consignment note. Therefore, Article 184 of Implementing Regulation (EU) 2015/2447 should be amended.

(5)

It is necessary to align Annexes 32-01, 32-02 and 32-03 and Part II, Chapters VI and VII of Annex 72-04 to Implementing Regulation (EU) 2015/2447 with the Convention on a common transit procedure (4) to take into account the accession of Ukraine to that Convention, in accordance with Decision No 3/2022 of the EU-CTC Joint Committee (5). However, in order to use up the existing stock of the guarantor’s undertaking forms, the specimen forms laid down in Annexes 32-01, 32-02 and 32-03 and which are valid on the day before the entry into force of this Regulation, should continue to apply until 1 April 2024, subject to the necessary geographical adaptations in point 1 of those Annexes and the mention of the name and address for service of the authorised agent in Ukraine in point 4 of those Annexes.

(6)

Implementing Regulation (EU) 2015/2447 should therefore be amended accordingly.

(7)

The measures provided for in this Regulation are in accordance with the opinion of the Customs Code Committee,

(1)

in Article 36, the following paragraph 3 is added:

(2)

Article 184 is amended as follows:

(3)

in Part I (Undertaking by the guarantor) of Annex 32-01, point 1 is amended as follows:

(4)

in Part I (Undertaking by the guarantor), point 1, of Annex 32-02, the word ‘Ukraine,’ is inserted after the text ‘the Republic of Turkey’;

(5)

in Part I (Undertaking by the guarantor) of Annex 32-03, point 1 is amended as follows:

(6)

in Part II, Chapter VI (Comprehensive guarantee certificate) (TC 31 Comprehensive guarantee certificate) (Front), point 7, of Annex 72-04, the word ‘Ukraine’, is inserted after the text ‘Turkey’;

(7)

in Part II, Chapter VII (Guarantee waiver certificate) (TC33 Guarantee waiver certificate) (Front), point 6, of Annex 72-04, the word ‘Ukraine’, is inserted after the text ‘Turkey’.

(1)

The Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part (1) (‘the Agreement’) entered into force on 1 September 2017.

(2)

The Preamble to the Agreement recognises the Parties’ desire to move the reform and approximation process forward in Ukraine, thus contributing to the gradual economic integration and deepening of political association, as well as to achieving economic integration through extensive regulatory approximation.

(3)

Article 1(2), point (d), of the Agreement refers to the objective to support Ukrainian efforts to complete the transition into a functioning market economy by means of, inter alia, the progressive approximation of its legislation to that of the Union.

(4)

Pursuant to Article 459(1) of the Agreement, the Parties are to implement assistance in accordance with the principles of sound financial management and cooperate in protecting of the financial interests of the EU and of Ukraine as set out in Annex XLIII to the Agreement. The Parties are to take effective measures to prevent and fight fraud, corruption and any other illegal activities, inter alia, by means of mutual administrative assistance and mutual legal assistance in the fields covered by the Agreement.

(5)

Pursuant to Article 459(2) of the Agreement, Ukraine is to also gradually approximate its legislation in line with the provisions as set out in Annex XLIV to the Agreement.

(6)

Article 474 of the Agreement provides for the general commitment of Ukraine to carry out gradual approximation of its legislation to EU law, based on commitments identified in, inter alia, Title VI of the Agreement. Commitments concerning gradual approximation of Ukrainian legislation to EU law identified in Title VI of the Agreement include protection of the financial interests of the EU and of Ukraine in the context of financial assistance provided through the relevant EU funding mechanisms and instruments in order to achieve the objectives of the Agreement, taking into account Ukraine’s needs, sector capacities and progress with reforms.

(7)

Pursuant to Article 463(1) and (3) of the Agreement, the Association Council has the power to take decisions for the purpose of attaining the objectives of the Agreement. In particular, it may update or amend the Annexes to the Agreement, taking into account the evolution of EU law and applicable standards set out in international instruments deemed relevant by the Parties.

(8)

Since the conclusion of negotiations for the Agreement, EU law on protection of the financial interests of the European Union, provisions of which were incorporated in Annex XLIV to the Agreement, was replaced by Directive (EU) 2017/1371 of the European Parliament and of the Council (2), and thus Ukraine’s commitments envisaged by the implementation of the Agreement have changed as well. Those amendments of EU law need to be reflected in Annex XLIV to the Agreement, which therefore needs to be amended.

(9)

The Association Council is therefore to amend Annex XLIV to the Agreement and to adjust the deadline for implementation of the provisions referred to in that Annex in order to take into account the new amendments of EU law.

(10)

It is appropriate to establish the position to be taken on the Union’s behalf within the Association Council, as regards the amendment of Annex XLIV to the Agreement,