0.18.3

(1)

In order to ensure a sufficient and uninterrupted supply of certain agricultural and industrial products which are produced in insufficient quantities in the Union and thereby avoid any disturbances on the market for those products, autonomous tariff quotas of the Union (‘quotas’) were opened by Council Regulation (EU) 2021/2283 (1). Within those quotas, products can be imported into the Union at reduced or zero duty rates.

(2)

As it is in the Union's interest to ensure an adequate supply of certain industrial products, and having regard to the fact that identical, equivalent or substitute products are not produced in sufficient quantities within the Union, it is necessary to open new quotas with order numbers 09.2819, 09.2839, 09.2855, 09.2857 and 09.2702 at zero duty rates for appropriate quantities of those products.

(3)

As the scope of the quotas with order numbers 09.2583 and 09.2876 has become inadequate to fulfil the needs of the economic operators in the Union, the description of the products covered by those quotas should be amended. The indication of the applicable TARIC code for those products should therefore be amended.

(4)

As it is no longer in the Union's interest to maintain the quotas with order numbers 09.2637, 09.2679 and 09.2740, those quotas should be closed with effect from 1 July 2022.

(5)

Taking into account the amendments to be made and for the sake of clarity, the Annex to Regulation (EU) 2021/2283 should be replaced.

(6)

In order to avoid any interruption in the application of the quota scheme and to comply with the guidelines set out in the communication from the Commission of 13 December 2011 concerning autonomous tariff suspensions and quotas, the changes provided for in this Regulation regarding the quotas for the products concerned should apply from 1 July 2022. This Regulation should therefore enter into force as a matter of urgency,

(1)

Regulation (EU) 2019/1009 lays down rules on the making available on the market of EU fertilising products. EU fertilising products contain component materials of one or more of the categories listed in Annex II to that Regulation. In accordance with component material category (‘CMC’) 11 of that Annex, EU fertilising products may contain by-products within the meaning of Directive 2008/98/EC of the European Parliament and of the Council (2), with some exceptions, which are to be registered in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3).

(2)

Article 42(7) of Regulation (EU) 2019/1009 requires the Commission to supplement Part II, CMC 11, point 3, of Annex II, by laying down criteria for agronomic efficiency and safety for the use of by-products within the meaning of Directive 2008/98/EC in EU fertilising products. To that end, the Commission mandated its Joint Research Centre (‘JRC’) to provide scientific advice (4).

(3)

By-products within the meaning of Directive 2008/98/EC build a very heterogeneous category of substances. These substances have different physical and chemical nature, and may be obtained during various production processes. For the purpose of this Regulation, the by-products are divided in two categories, depending on their type of agronomic efficiency. The first category concerns by-products, which provide nutrients to plants or mushrooms or improve their nutrition efficiency. The second category concerns by-products which are used as technical additives in smaller concentrations. Even though they are not directly linked to nutrition or nutrition efficiency, they do improve the quality of the fertilising product or the safety in handling it.

(4)

For the first category, the JRC has identified by-products resulting from a variety of production processes, which contain ammonium salts, sulphate salts, phosphate salts, elemental sulphur, calcium carbonate and calcium oxide. To ensure that those by-products have a clear agronomic value and do not create adverse effects for human health and the environment, a strict purity requirement should be laid down.

(5)

For the second category, the JRC proposed to allow the use of by-products as technical additives, such as hardening, binding or filling agents, or anti-dusting agents to improve the health protection of users. To ensure that the use of such by-products does not jeopardise the overall agronomic efficiency of the EU fertilising product and has no adverse effect on human health or the environment, a maximum concentration in the final EU fertilising product should be laid down.

(6)

In addition, the JRC assessed the most commonly used by-products according to existing practices. Those by-products have been selected based on their market potential, available data, on their current legal situation, on their use history and on their clear agronomic value, as well as based on the straightforwardness of safety criteria development given the time constraints in performing the assessment. The by-products identified were mother liquor from the reaction of 5(β-methyl-thioethyl)-hydantoin with potassium carbonate in the methionine production process, residues from mineral and ore processing and purification, post-distillation liquid from Solvay process, carbide lime from acetylene production, ferrous slags, metal salts from ore concentrate processing and metal surface treatment, and humic and fulvic acids from drinking water discolouration. These specific by-products should be used in EU fertilising products without having to comply with restrictive purity levels for the first category of by-products or with the purpose and a maximum concentration allowed for the second category of by-products. The reason is that such by-products are clearly identified, which allowed the JRC to thoroughly assess their agronomic value and all the specific risks they may raise.

(7)

Furthermore, the corresponding supplementary safety criteria for the use of by-products should be laid down.

(8)

Some of those by-products should comply with safety criteria limiting the content of contaminants and other substances of concern, applied in addition to those that are laid down in Annex I to Regulation (EU) 2019/1009 for the corresponding product function category, and without prejudice to Regulation (EU) 2019/1021 of the European Parliament and of the Council (5).

(9)

Additional limit values should be laid down for the contaminants total chromium, thallium and vanadium. Some of the by-products may contain such contaminants as a result of the particularity of their production process. The proposed limit values for those contaminants should ensure that the use of EU fertilising products containing by-products with such contaminants does not lead to their accumulation in soil. The limit values for such contaminants should be determined as concentration in the final product, similar to the requirements set out in Annex I to Regulation (EU) 2019/1009. This is justified by the fact that the safety criteria introduced in reply to any particular risks identified concern, as a rule, the final product and not a component material. This should facilitate the conformity assessment and market surveillance of such products, as tests are to be carried out only on the final product.

(10)

Residues from the processing or purification of sedimentary phosphate ore are known to contain naturally occurring radionuclides. In order to ensure safe use of such by-products in EU fertilising products, it is appropriate to lay down maximum permitted levels of activity concentration values of naturally occurring radionuclides, from the uranium and thorium series in EU fertilising products containing such materials.

(11)

Furthermore, additional safety criteria should be laid down to limit the content of 16 polycyclic aromatic hydrocarbons (PAH16) (6) and of polychlorinated dibenzo-p-dioxins and dibenzofurans (PCDD/PCDF) (7). Regulation (EU) 2019/1021 lays down release reductions for PAH16 and PCDD/PCDF as unintentionally produced substances during manufacturing processes, but does not introduce a limit value in such cases. Given the high risks generated by the presence of such pollutants in fertilising products, it is considered appropriate to introduce more stringent requirements than those laid down in that Regulation. Such limit values should be laid down at component material level and not as concentration in the final product, to ensure coherence with Regulation (EU) 2019/1021.

(12)

The limit values for contaminants, PAH16 and PCDD/PCDF may not be relevant in all cases. Therefore, manufacturers should have the possibility to presume the conformity of the fertilising product with a given requirement without verification, such as testing, whenever the compliance with the said requirement follows certainly and uncontestably from the nature or manufacturing process of the by-products belonging to CMC 11 or of the EU fertilising product containing such a by-product.

(13)

Some of the by-products may contain selenium, which can be toxic if present in high concentration. Some may also contain chloride, which may raise concerns regarding the salinity in soil. Whenever those substances are present in concentrations exceeding a certain limit, their content should be indicated on the label so that the users of the fertilising product are properly informed.

(14)

Given that Regulation (EU) 2019/1009 will fully apply from 16 July 2022, it is necessary to defer the application of this Regulation to the same date,

(1)

Pursuant to Article 50(2)(a) of Regulation (EU) No 1151/2012, France’s application to register the name ‘Cidre du Perche/Perche’ was published in the Official Journal of the European Union (2).

(2)

As no statement of opposition under Article 51 of Regulation (EU) No 1151/2012 has been received by the Commission, the name ‘Cidre du Perche/Perche’ should therefore be entered in the register,

(1)

Regulation (EU) No 1286/2014 lays down uniform rules on the format and content of the key information document to be drawn up by PRIIP manufacturers and on the provision of the key information document to retail investors in order to enable retail investors to understand and compare the key features and risks of the PRIIP. However, pursuant to Article 32(1) of that Regulation, management companies as defined in Article 2(1), point (b), of Directive 2009/65/EC of the European Parliament and of the Council (2), investment companies as referred to in Article 27 thereof and persons advising on, or selling, units of UCITS as referred to in Article 1(2) thereof were exempt from the obligations under that Regulation until 31 December 2021. When a Member State applies rules on the format and content of the key information document, as laid down in Articles 78 to 81 of Directive 2009/65/EC, to non-UCITS funds offered to retail investors, the transitional arrangement laid down in Article 32(1) of that Regulation applies to management companies, investment companies and persons advising on, or selling, units of such funds to retail investors. Regulation (EU) 2021/2259 of the European Parliament and of the Council (3) amended Regulation (EU) No 1286/2014 to extend that transitional arrangement until 31 December 2022.

(2)

Commission Delegated Regulation (EU) 2017/653 (4), which was adopted on the basis of Articles 8(5), 10(2) and 13(5) of Regulation (EU) No 1286/2014, lays down rules with regard to the presentation, content, review and revision of key information documents and the conditions for fulfilling the requirement to provide such documents. Article 14(2) of that Delegated Regulation allowed PRIIP manufacturers to use the key investor information document drawn up in accordance with Articles 78 to 81 of Directive 2009/65/EC to provide specific information for the purposes of Articles 11 to 13 of that Delegated Regulation, rather than the key information document referred to in that Delegated Regulation (EU) 2017/653, until 31 December 2019, provided that at least one of the underlying investment options referred to in Article 14(1) of that Delegated Regulation is a UCITS or non-UCITS fund as referred to in Article 32 of Regulation (EU) No 1286/2014. Commission Delegated Regulation (EU) 2019/1866 (5) extended that transitional arrangement until 31 December 2021, and Commission Delegated Regulation (EU) 2021/2268 (6) amended Delegated Regulation (EU) 2017/653 to further extend that transitional arrangement until 30 June 2022.

(3)

Since Regulation (EU) 2021/2259 has now extended the transitional arrangement referred to in Article 32 of Regulation (EU) No 1286/2014 until 31 December 2022, it is necessary that that extension is also reflected in Delegated Regulation (EU) 2017/653, and that the transitional arrangement is further extended from 30 June 2022 until 31 December 2022. Delegated Regulation (EU) 2017/653 should therefore be amended accordingly.

(4)

It is necessary to ensure that Delegated Regulation (EU) 2021/2268 only applies as of the day that follows the end of the transitional arrangement laid down in Article 32 of Regulation (EU) No 1286/2014. The date laid down in Article 2, second paragraph, of Delegated Regulation (EU) 2021/2268 should therefore be replaced. Delegated Regulation (EU) 2021/2268 should therefore be amended accordingly,

(1)

Regulation (EU) 2016/429 requires that consignments of animals, germinal products and products of animal origin must come from a third country or territory, or zone or compartment thereof, listed in accordance with Article 230(1) of that Regulation in order to enter the Union.

(2)

Commission Delegated Regulation (EU) 2020/692 (2) lays down the animal health requirements with which consignments of certain species and categories of animals, germinal products and products of animal origin from third countries or territories, or zones thereof, or compartments thereof, in the case of aquaculture animals, must comply with in order to enter the Union.

(3)

Commission Implementing Regulation (EU) 2021/404 (3) establishes the lists of third countries, or territories, or zones or compartments thereof, from which the entry into the Union of the species and categories of animals, germinal products and products of animal origin falling within the scope of Delegated Regulation (EU) 2020/692 is permitted.

(4)

More particularly, Annexes V and XIV to Implementing Regulation (EU) 2021/404 set out the lists of third countries, or territories, or zones thereof authorised for the entry into the Union, respectively, of consignments of poultry, germinal products of poultry, and of fresh meat from poultry and game birds.

(5)

Canada notified the Commission of one outbreak of highly pathogenic avian influenza in poultry located in the province of Saskatchewan, Canada, and it was confirmed on 4 May 2022 by laboratory analysis (RT-PCR).

(6)

In addition, Canada notified the Commission of two outbreaks of highly pathogenic avian influenza in poultry, both located in the province of British Columbia, Canada, and they were confirmed on 4 June 2022 by laboratory analysis (RT-PCR).

(7)

The United Kingdom notified the Commission of one outbreak of highly pathogenic avian influenza near Southwell, Newark and Sherwood, Nottinghamshire, England, United Kingdom, and it was confirmed on 19 May 2022 by laboratory analysis (RT-PCR).

(8)

In addition, the United Kingdom notified the Commission of one outbreak of highly pathogenic avian influenza near Bexhill-on-Sea, Rother, East Sussex, England, United Kingdom, and it was confirmed on 15 June 2022 by laboratory analysis (RT-PCR).

(9)

The United States notified the Commission of one outbreak of highly pathogenic avian influenza in poultry located in the state of North Dakota, United States, and it was confirmed on 6 June 2022 by laboratory analysis (RT-PCR).

(10)

In addition, the United States notified the Commission of three outbreaks of highly pathogenic avian influenza in poultry: one outbreak is located in the state of Colorado, United Sates, another outbreak is located in the state of Indiana, United States and a further outbreak is located in the state of Washington, United States and they were all confirmed on 7 June 2022 by laboratory analysis (RT-PCR).

(11)

Following those outbreaks of highly pathogenic avian influenza, the veterinary authorities of Canada, the United Kingdom and the United States established a 10 km control zone around the affected establishments and implemented a stamping-out policy in order to control the presence of highly pathogenic avian influenza and limit the spread of that disease.

(12)

Canada, the United Kingdom and the United States have submitted information to the Commission on the epidemiological situation on their territory and the measures they have taken to prevent the further spread of highly pathogenic avian influenza. That information has been evaluated by the Commission. On the basis of that evaluation and in order to protect the animal health status of the Union, the entry into the Union of consigments of poultry, germinal products of poultry, and fresh meat from poultry and game birds from the areas under restrictions established by the veterinary authorities of Canada, the United Kingdom and the United States due to the recent outbreaks of highly pathogenic avian influenza should no longer be authorised.

(13)

Moreover, Canada has submitted updated information on the epidemiological situation on its territory in relation to one outbreak of highly pathogenic avian influenza in poultry establishments in the province of Nova Scotia, Canada confirmed on 8 February 2022. Canada has also submitted information on the measures it has taken to prevent the further spread of that disease. In particular, following this outbreak of highly pathogenic avian influenza, Canada has implemented a stamping out policy in order to control and limit the spread of that disease. In addition, Canada has completed the requisite cleaning and disinfection measures following the implementation of the stamping out policy on the infected poultry establishments on its territory.

(14)

Moreover, the United Kingdom has submitted updated information on the epidemiological situation on its territory in relation to ten outbreaks of highly pathogenic avian influenza in poultry establishments: one outbreak near Alford, East Lindsey, Lincolnshire, England, United Kingdom, which was confirmed on 16 December 2021, one outbreak near Washington, Sunderland, Tyne & Wear, England, United Kingdom, which was confirmed on 11 December 2021, one outbreak near Mablethorpe, East Lindsey, Lincolnshire, England, United Kingdom, which was confirmed on 31 December 2021, one outbreak near Eton, Windsor & Maidenhead, Berkshire, England, United Kingdom, which was confirmed on 2 January 2022, one outbreak near Alford, East Lindsey, Lincolnshire, England, United Kingdom which was confirmed on 3 January 2022, one outbreak near Upholland, West Lancashire, Lancashire, England, United Kingdom, which was confirmed on 7 January 2022, one outbreak near Byker, Newcastle Upon Tyne, Tyne & Wear, England, United Kingdom, which was confirmed on 25 January 2022, one outbreak near Bishop’s Waltham, Winchester, Hampshire, England, which was confirmed on 4 February 2022, one outbreak near Welshpool, Montgomeryshire, Powys, Wales, United Kingdom, which was confirmed on 21 February 2022 and one outbreak near Collieston, Aberdeenshire, Scotland, United Kingdom, which was confirmed on 11 March 2022. The United Kingdom has also submitted information on the measures it has taken to prevent the further spread of that disease. In particular, following these outbreaks of highly pathogenic avian influenza, the United Kingdom has implemented a stamping out policy in order to control and limit the spread of that disease. In addition, the United Kingdom has completed the requisite cleaning and disinfection measures following the implementation of the stamping out policy on the infected poultry establishments on its territory.

(15)

The Commission has evaluated the information submitted by Canada and the United Kingdom and concluded that the highly pathogenic avian influenza outbreaks in poultry establishments have been cleared and that there is no longer any risk associated with the entry into the Union of poultry commodities from the zones of Canada and the United Kingdom from which the entry into the Union of poultry commodities were suspended due to these outbreaks.

(16)

Annexes V and XIV to Implementing Regulation (EU) 2021/404 should be therefore amended to take account of the current epidemiological situation as regards highly pathogenic avian influenza in Canada, the United Kingdom and the United States. Regulation (EU) 2021/404 should therefore be amended accordingly.

(17)

Taking into account the current epidemiological situation in Canada, the United Kingdom and the United States as regards highly pathogenic avian influenza and the serious risk of its introduction into the Union, the amendments to be made to Implementing Regulation (EU) 2021/404 by this Regulation should take effect as a matter of urgency.

(18)

The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,