ISSN 1977-0677 |
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Official Journal of the European Union |
L 236 |
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English edition |
Legislation |
Volume 65 |
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(1) Text with EEA relevance. |
EN |
Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period. The titles of all other Acts are printed in bold type and preceded by an asterisk. |
II Non-legislative acts
REGULATIONS
13.9.2022 |
EN |
Official Journal of the European Union |
L 236/1 |
COMMISSION DELEGATED REGULATION (EU) 2022/1518
of 29 March 2022
amending Regulation (EC) No 273/2004 of the European Parliament and of the Council and Council Regulation (EC) No 111/2005 as regards the inclusion of certain drug precursors in the list of scheduled substances
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 273/2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors (1), and in particular Article 15 thereof,
Having regard to Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Union and third countries in drug precursors (2), and in particular Article 30a thereof,
Whereas:
(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, |
HAS ADOPTED THIS REGULATION:
Article 1
Amendments to Regulation (EC) No 273/2004
Annex I to Regulation (EC) No 273/2004 is amended in accordance with Annex I to this Regulation.
Article 2
Amendments to Regulation (EC) No 111/2005
The Annex to Regulation (EC) No 111/2005 is amended in accordance with Annex II to this Regulation.
Article 3
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 29 March 2022.
For the Commission
The President
Ursula VON DER LEYEN
(3) Council Decision 90/611/EEC of 22 October 1990 concerning the conclusion, on behalf of the European Economic Community, of the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (OJ L 326, 24.11.1990, p. 56).
ANNEX I
In Regulation (EC) No 273/2004, in Annex I, in the table for Category 1, the following entries are inserted in the list of substances in the appropriate place sequentially according to the CN Code:
Substance |
CN designation (if different) |
CN Code |
CAS No |
‘ethyl alpha-phenylacetoacetate (EAPA) (*1) |
|
Ex29183000 |
5413-05-8 |
methyl 3-oxo-2-(3,4-methylenedioxyphenyl)butanoate (MAMDPA) (*2) |
methyl 3-oxo-2-(3,4-methylenedioxyphenyl)butanoate |
Ex29329900 |
1369021-80-6 |
(*1) also known as ethyl 3-oxo-2-phenylbutanoate, according to IUPAC (The International Union of Pure and Applied Chemistry).
(*2) also known as methyl 2-(2H-1,3-benzodioxol-5-yl)-3-oxobutanoate, according to IUPAC.’.
ANNEX II
In Regulation (EC) No 111/2005, in the Annex, in the table for Category 1, the following entries are inserted in the list of substances in the appropriate place sequentially according to the CN Code:
Substance |
CN designation (if different) |
CN Code |
CAS No |
‘ethyl alpha-phenylacetoacetate (EAPA) (*1) |
|
Ex29183000 |
5413-05-8 |
methyl 3-oxo-2-(3,4-methylenedioxyphenyl)butanoate (MAMDPA) (*2) |
methyl 3-oxo-2-(3,4-methylenedioxyphenyl)butanoate |
Ex29329900 |
1369021-80-6 |
(*1) also known as ethyl 3-oxo-2-phenylbutanoate, according to IUPAC (The International Union of Pure and Applied Chemistry).
(*2) also known as methyl 2-(2H-1,3-benzodioxol-5-yl)-3-oxobutanoate, according to IUPAC.’.
13.9.2022 |
EN |
Official Journal of the European Union |
L 236/5 |
COMMISSION DELEGATED REGULATION (EU) 2022/1519
of 5 May 2022
amending Regulation (EU) 2019/1009 of the European Parliament and of the Council as regards the requirements applicable to EU fertilising products containing inhibiting compounds and the post processing of digestate
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (1), and in particular Article 42(1) thereof,
Whereas:
(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, |
HAS ADOPTED THIS REGULATION:
Article 1
Regulation (EU) 2019/1009 is amended as follows:
(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. |
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 5 May 2022.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 170, 25.6.2019, p. 1.
(2) Commission Delegated Regulation (EU) 2021/1768 of 23 June 2021 amending, for the purpose of its adaptation to technical progress, Annexes I, II, III and IV to Regulation (EU) 2019/1009 of the European Parliament and of the Council laying down rules on the making available on the market of EU fertilising products (OJ L 356, 8.10.2021, p. 8).
(3) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
(4) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Chemicals Strategy for Sustainability, towards a Toxic-Free Environment, COM(2020) 667 final of 14 October 2020.
(5) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
(6) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Pathway to a Healthy Planet for All EU Action Plan: ‘Towards Zero Pollution for Air, Water and Soil’, COM(2021) 400 final of 12 May 2021.
(7) Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: A Farm to Fork Strategy for a fair, healthy and environmentally-friendly food system, COM(2020) 381 final of 20 May 2020.
(8) Saveyn H, Eder P. End-of-waste criteria for biodegradable waste subjected to biological treatment (compost and digestate): Technical proposals, EUR 26425, Publications Office of the European Union, 2013. JRC87124.
(9) Digestate and compost as fertilisers: Risk assessment and risk management options, 2019, 40039CL003i3.
(10) Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (OJ L 169, 25.6.2019, p. 45).
ANNEX I
Part II of Annex I to Regulation (EU) 2019/1009 is amended as follows:
(1) |
in point 2 of PFC 1(C), the second indent is replaced by the following:
|
(2) |
Section ‘PFC 7’ is amended as follows:
|
ANNEX II
Part II of Annex II to Regulation (EU) 2019/1009 is amended as follows:
(1) |
Section ‘CMC 1’ is amended as follows:
|
(2) |
in point 1(d) of Section ‘CMC 3’, sub-point (i) is replaced by the following:
|
(3) |
Section ‘CMC 4’ is amended as follows:
|
(4) |
Section ‘CMC 5’ is amended as follows:
|
(5) |
in Section ‘CMC 6’, point 2 is replaced by the following:
|
(6) |
in Section ‘CMC 11’, point 2 is replaced by the following:
|
(7) |
in Section ‘CMC 12’, point 13 is replaced by the following:
|
(8) |
in Section ‘CMC 13’, point 8 is replaced by the following:
|
(9) |
Section ‘CMC 14’ is amended as follows:;
|
(10) |
in Section ‘CMC 15’, point 10 is replaced by the following:
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(*) In the case of a substance recovered in the European Union, this condition is fulfilled if the substance is the same, within the meaning of point (d)(i) of Article 2(7) of Regulation (EC) No 1907/2006, as a substance registered with a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of point (d)(ii) of Article 2(7) of Regulation (EC) No 1907/2006.’;
(**) Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, indeno[1,2,3-cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene.’;’
ANNEX III
Part II of Annex III to Regulation (EU) 2019/1009 is amended as follows:
(1) |
Section ‘PFC 1’ is amended as follows:
|
(2) |
Section ‘PFC 5: INHIBITOR’ is replaced by the following: ‘PFC 5: INHIBITOR
|
(3) |
in Section ‘PFC 7: FERTILISING PRODUCT BLEND’ the following paragraph is added: ‘Where the fertilising product blend contains one or more inhibitors belonging to PFC 5, the use instructions referred to in point 3 in PFC 5 in Part II of this Annex shall not be added.’. In Part III of Annex III, Section ‘PFC 1: FERTILISER’ is replaced by the following: ‘PFC 1: FERTILISER The following tolerance rules apply to fertilisers containing nitrification, denitrification or urease inhibiting compounds, as specified in CMC 1 in Part II of Annex II:
|
ANNEX IV
Part I of Annex IV to Regulation (EU) 2019/1009 is amended as follows:
(1) |
in point 1.1, sub-point (a) is replaced by the following:
|
(2) |
in point 3.1, sub-point (a) is replaced by the following:
|
13.9.2022 |
EN |
Official Journal of the European Union |
L 236/16 |
COMMISSION DELEGATED REGULATION (EU) 2022/1520
of 17 June 2022
amending Regulation (EU) No 658/2014 of the European Parliament and of the Council as regards the adjustment to the inflation rate of the amounts of the fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (1), and in particular Article 15(6) thereof,
Whereas:
(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, |
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Regulation (EU) No 658/2014 is amended as follows:
(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’. |
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 3 October 2022.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 17 June 2022.
For the Commission
The President
Ursula VON DER LEYEN
(1) OJ L 189, 27.6.2014, p. 112.
(2) Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
(3) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(4) Eurostat, euroindicators 11/2022, published on 20 January 2022.