(1)

Regulation (EC) No 273/2004 lays down measures for monitoring trade in drug precursors within the Union, while Regulation (EC) No 111/2005 governs trade in drug precursors between the Union and third countries. Annex I to Regulation (EC) No 273/2004 and the Annex to Regulation (EC) No 111/2005 each contain a list of scheduled substances, which are subject to a number of harmonised control and monitoring measures provided for by those Regulations.

(2)

National competent authorities have reported the seizure of ethyl alpha-phenylacetoacetate (EAPA) and methyl 3-oxo-2-(3,4-methylenedioxyphenyl)butanoate (MAMDPA) in the context of illicit manufacture of narcotic drugs.

(3)

EAPA is used to produce 1-Phenyl-2-propanone (P-2-P), also known as benzyl methyl ketone (BMK). BMK is a precursor of amphetamine and methamphetamine.

(4)

MAMDPA is used to produce 3,4-Methylenedioxyphenylpropan-2-one (PMK), which, in turn, is a precursor of 3,4-methylenedioxymethamphetamine (MDMA), commonly known as ‘ecstasy’.

(5)

Amphetamine, methamphetamine and MDMA are some of the most common drugs illicitly produced in the Union. They have severe consequences for human health and are causing serious social and public health problems in some regions of the Union.

(6)

Therefore, EAPA and MAMDPA should be scheduled at Union level to reinforce their control and monitoring.

(7)

The scheduled substances listed in Annex I to Regulation (EC) No 273/2004 and in the Annex to Regulation (EC) No 111/2005 are divided into categories for which different measures apply, so as to achieve a proportionate balance between the level of threat posed by each specific substance and the burden on licit trade. The strictest control and monitoring measures apply to substances of Category 1.

(8)

EAPA and MAMDPA, as precursors to amphetamine, methamphetamine and MDMA, pose significant social and public health threats in the Union. They have no known licit production, trade or use, except for research purposes. Therefore, including them in Category 1 in Annex I to Regulation (EC) No 273/2004 and in Category 1 in the Annex to Regulation (EC) No 111/2005 would be an adequate response to avoid their use in the illicit manufacture of narcotic drugs and, at the same time, would not entail any significant extra administrative burden for economic operators and competent authorities in the Union.

(9)

Regulations (EC) No 273/2004 and (EC) No 111/2005 should therefore be amended accordingly.

(10)

Regulations (EC) No 273/2004 and (EC) No 111/2005 jointly implement certain provisions of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, done at Vienna on 20 December 1988 and approved by Council Decision 90/611/EEC (3). In view of the close substantive link between the empowerments contained in those Regulations, it is appropriate to adopt the amendments by way of one single delegated act,

(1)

A fertilising product, which meets the requirements laid down in Annexes I and II to Regulation (EU) 2019/1009 for the relevant product function category (‘PFC’) and component material category (‘CMC’) respectively, is labelled in accordance with Annex III to that Regulation and has successfully passed the conformity assessment procedure laid down in Annex IV to Regulation (EU) 2019/1009, can then be CE marked and can move freely in the internal market as an EU fertilising product.

(2)

While preparing for the transition to new harmonisation rules, both Member States and interested stakeholders informed the Commission about the need to adapt some of the technical provisions in the annexes to Regulation (EU) 2019/1009. Those adaptations are necessary to facilitate internal market access for fertilising products that are agronomically efficient, safe and already widely traded on the market. Some of those amendments facilitate the free movement of such products, i.e. safe and agronomically efficient fertilising products, by improving the consistency with other legal acts and policy objectives of the Union. Other amendments are necessary in order to avoid situations in which significant categories of fertilising products would inadvertently be excluded from the harmonisation rules.

(3)

Regulation (EU) 2019/1009, as amended by Commission Delegated Regulation (EU) 2021/1768 (2), allows manufacturers to use certain types of polymers in EU fertilising products if those are compliant with the conditions laid down for CMC 1 and CMC 11 in Annex II to Regulation (EU) 2019/1009. One of the conditions is that the polymer is registered in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3). In the Communication titled ‘Chemicals Strategy for Sustainability, towards a Toxic-Free Environment’ (4), the Commission announced the revision of Regulation (EC) No 1907/2006, extending a registration obligation to certain polymers. Consequently, for reasons of coherence and consistency, the registration obligation of polymers should, as a first step, be regulated under Regulation (EC) No 1907/2006, as the discussions for its revision offer a broader context and the possibility of taking a holistic approach, before becoming applicable under Regulation (EU) 2019/1009.

(4)

Regulation (EU) 2019/1009 lays down an obligation for the registration of magnesia in accordance with Regulation (EC) No 1907/2006. However, Regulation (EC) No 1907/2006 exempts magnesia, which is not chemically modified, from the registration obligation, as the registration is deemed inappropriate or unnecessary for that substance and its exemption from the registration obligation does not jeopardise the objectives of that Regulation. Magnesia has a long history of use in fertilisers and has no harmonised classification in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council (5). Taking that into account and in order to facilitate the access to the internal market of fertilisers containing magnesia as EU fertilising products, the registration obligation laid down in Regulation (EU) 2019/1009 should no longer apply to magnesia used in fertilisers.

(5)

Regulation (EU) 2019/1009 lays down requirements for inhibitors as EU fertilising products belonging to PFC 5 and for EU fertilising products containing inhibitors as a component material belonging to CMC 1. To avoid any confusions, the terminology used in that Regulation should be amended to reflect the distinction between the two situations. Thus, the term ‘inhibiting compound’ should be used whenever it concerns a substance or mixture which improves the nutrient release pattern of a nutrient by delaying or stopping the activity of specific groups of micro-organisms or enzyme. The term ‘inhibitor’ should be used only when it refers to EU fertilising products belonging to PFC 5. This distinction is important as inhibitors may be mixtures containing other substances, like stabilisers, in addition to inhibiting compounds. Correct use of those terms is necessary to facilitate the free movement of EU fertilising products, by clearly laying down the rules applicable in each situation.

(6)

Regulation (EU) 2019/1009 includes requirements ensuring that the inhibiting compounds are efficient, but does not lay down requirements on the efficiency of the fertiliser or the blend containing such an inhibiting compound. The use of efficient products containing such substances helps avoiding the environmental pollution caused by the leaching of nitrogen. Commission Communications titled ‘Pathway to a Healthy Planet for All EU Action Plan: “Towards Zero Pollution for Air, Water and Soil”’ (6) and ‘A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system’ (7) mention the environmental concerns and the ambitious targets to reduce nutrient losses by 50 % by 2030. It is therefore important to ensure that the EU fertilising products, which contain inhibiting compounds, are efficient. Therefore, Regulation (EU) 2019/1009 should be amended to include a requirement that inhibiting compounds are present in fertilisers (PFC 1) or in fertilising product blend (PFC 7) in a concentration, which is within the range of concentrations that ensures the efficiency of the inhibiting compound. Furthermore, additional labelling requirements should ensure that the manufacturers of inhibitors referred to in PFC 5 provide clear instructions on how to mix such products with a fertiliser to ensure their efficiency.

(7)

Regulation (EU) 2019/1009 lays down rules on the use of fresh crop digestate and on digestate other than fresh crop digestate, hereafter commonly referred to as ‘digestate’, as component materials in EU fertilising products. That Regulation lays down rules for the digestion processes. However, it does not provide for any other rules for post processing of the digestate.

(8)

The Joint Research Centre (JRC) report titled ‘End-of-waste criteria for biodegradable waste subjected to biological treatment (compost & digestate): Technical proposals’ (8) states that digestate is often used in agriculture, either as a whole or following separation in a solid and liquid fraction. That separation facilitates the storing of materials and their long-distance transport, which is especially important for a CE marked product. The mechanical separation of a digestate in the solid and liquid fractions is a commonly used method in some Member States and seems to be a well-established method according to a recent study titled ‘Digestate and compost as fertilisers: Risk assessment and risk management options’ (9). The separation of a digestate in the solid and liquid fractions could pose limited risks if conditions regarding the post digestion process and the additives to be used are laid down. Therefore, Regulation (EU) 2019/1009 should be amended to include this post digestion process, under the conditions that the additives used do not exceed a certain concentration and are registered in accordance with Regulation (EC) No 1907/2006. Allowing these processes in Regulation (EU) 2019/1009 is necessary in order to facilitate the access to the internal market for EU fertilising products containing digestate and to adapt the requirements laid down for these component material categories to technical progress. It will also create new opportunities for the recovery of bio-waste, which is in line with the overall ambitious plans for a circular economy.

(9)

Besides the mechanical separation of a digestate in the solid and liquid fractions, other processes are commonly used to remove water from a digestate or its fractions. Regulation (EU) 2019/1009 should allow manufacturers to further process the digestate or its fractions in order to extract water, without the intention to otherwise chemically modify the component materials. Furthermore, nitrogen or phosphorus may be recovered out of a digestate via stripping or precipitation. To close the loop, it is important not only to create the possibility for the recovery of these nutrients out of digestate, but also to allow for the use of the remaining digestate in EU fertilising products, given that it contains various other nutrients and organic matter. In addition, requirements for the use of additives needed for such processes should be laid down.

(10)

Regulation (EU) 2019/1009 applies without prejudice to Regulation (EU) 2019/1021 of the European Parliament and of the Council (10), which lays down general rules applicable to persistent organic pollutants. Regulation (EU) 2019/1009 lays down a limit value of 0,8 mg/kg dry matter of ndl-PCB for pyrolysis and gasification materials belonging to CMC 14. However, in accordance with Regulation (EU) 2019/2021, PCB are not to be present in substances or mixtures placed on the EU market. To ensure coherence with Regulation (EU) 2019/1021 and clarity as to the fact that no ndl-PCB is to be contained in EU fertilising products with pyrolysis or gasification materials, that limit value in Regulation (EU) 2019/1009 should be deleted.

(11)

Regulation (EU) 2019/1009 should therefore be amended accordingly,

(1)

Annex I is amended in accordance with Annex I to this Regulation;

(2)

Annex II is amended in accordance with Annex II to this Regulation;

(3)

Annex III is amended in accordance with Annex III to this Regulation;

(4)

Annex IV is amended in accordance with Annex IV to this Regulation.

(1)

In accordance with Article 67(3) of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2), the revenue of the European Medicines Agency includes fees paid by undertakings for obtaining and maintaining Union marketing authorisations and for other services provided by the Agency, and for services provided by the coordination group as regards the fulfilment of its tasks in accordance with Articles 107c, 107e, 107g, 107k and 107q of Directive 2001/83/EC of the European Parliament and of the Council (3).

(2)

The last adjustment of the fees and remuneration amounts laid down in Regulation (EU) No 658/2014 was carried out in 2020 based on the cumulative inflation rate of 2018 and 2019. The inflation rate of the Union for the years 2020 and 2021, as published by the Statistical Office of the European Union, was respectively 0,3 % and 5,3 % (4). Taking into consideration the level of the inflation rates for those years, it is considered justified to adjust, in accordance with Article 15(6) of Regulation (EU) No 658/2014, the amounts of the fees and the amounts of the remuneration for rapporteurs and co-rapporteurs referred to in Parts I to IV of the Annex to that Regulation. A cumulative adjustment taking into account the inflation rates for both 2020 and 2021 should therefore be applied.

(3)

For the sake of simplicity, the adjusted amounts should be rounded to the nearest EUR 10, with the exception of the annual fee for information technology systems and literature monitoring where the adjusted level should be rounded to the nearest EUR 1.

(4)

Fees laid down in Regulation (EU) No 658/2014 are due either at the date of the start of the respective procedure or, in the case of the annual fee for information technology systems and literature monitoring, on 1 July of every year. Consequently, the applicable amount will be determined by the due date of the fee and there is no need to set specific transitional provisions for pending procedures.

(5)

In accordance with Article 15(6) of Regulation (EU) No 658/2014, where an act adjusting the amounts of the fees laid down in Parts I to IV of the Annex to that Regulation enters into force before 1 July, the adjustments are to take effect as from 1 July, whereas where it enters into force after 30 June, the adjustments are to take effect from the date of entry into force of the act. The date of application for this Regulation should be laid down in accordance with that provision.

(6)

Regulation (EU) No 658/2014 should therefore be amended accordingly,

(1)

in Part I, point 1 is amended as follows:

(2)

in Part II, point 1 is amended as follows:

(3)

in Part III, point 1 is amended as follows:

(4)

in point 1 of Part IV, ‘EUR 71’ is replaced by ‘EUR 75’.