Regulation (EU) 2024/2516 of the European Parliament and of the Council of 18 September 2024 amending Regulation (EU) 2019/1009 as regards the digital labelling of EU fertilising products (Text with EEA relevance)

• CELEX: Regulation (EU) 2024/2516
• Articles: 4

Article 1 Forms of labelling

Regulation (EU) 2019/1009 is amended as follows:

(1)

Article 2 is amended as follows:

(a)

the following point is inserted:

‘(10a)

“packaging” means a sealable receptacle holding not more than 1 000 kg;’

;

(b)

the following point is inserted:

‘(16a)

“data carrier” means a linear bar-code symbol, two-dimensional symbol or other automatic identification data capture medium that can be read by a device;’

;

(2)

Article 6 is amended as follows:

(a)

in paragraph 5, the following subparagraph is added:

‘The information referred to in the first subparagraph shall be provided physically on the packaging or the accompanying document, digitally, or both. Where the information is provided digitally, the requirements set out for digital labels in Article 11b and the obligations set out in Article 11c shall apply.’

;

(b)

in paragraph 6, the following subparagraph is added:

‘The information referred to in the first subparagraph shall be provided physically on the packaging or the accompanying document or both physically on the packaging or the accompanying document and digitally. Where the information is provided digitally, the requirements set out for digital labels in Article 11b and the obligations set out in Article 11c shall apply.’

;

(c)

paragraph 7 is replaced by the following:

‘7.   Manufacturers shall ensure that EU fertilising products are accompanied by the labelling elements required under Annex III, provided in the relevant form as set out in Article 11a. Those labelling elements shall be:

(a)

in a language which can be easily understood by end-users, as determined by the Member State concerned;

(b)

clear, understandable, accurate, intelligible and prominently placed on the packaging;

(c)

accessible for inspection purposes when the EU fertilising product is made available on the market.’

;

(3)

in Article 8, paragraph 4 is replaced by the following:

‘4.   Importers shall ensure that EU fertilising products are accompanied by the labelling elements required under Annex III, provided in the relevant form set out in Article 11a. Those labelling elements shall be:

(a)

in a language which can be easily understood by end-users, as determined by the Member State concerned;

(b)

accessible for inspection purposes when the EU fertilising product is made available on the market.’

;

(4)

the following articles are inserted:

‘Article 11a

Forms of labelling

1.   Where EU fertilising products are made available to economic operators on the market in packaging, they shall be accompanied by the labelling elements set out in Annex III in the following form:

(a)

on a label in a digital form (“digital label”); or

(b)

on a label in a physical form attached to the packaging or, for the labelling elements that cannot be provided on the label due to the packaging being too small, in a separate leaflet accompanying the packaging (“physical label”).

2.   Where EU fertilising products are made available to economic operators on the market without packaging, they shall be accompanied by the labelling elements set out in Annex III in the following form:

(a)

on a digital label; or

(b)

in a leaflet accompanying the EU fertilising product.

3.   Where EU fertilising products are made available to end-users on the market in packaging, they shall be accompanied by the labelling elements set out in Annex III in the following form:

(a)

on a physical label; or

(b)

on a digital label and duplicated on a physical label.

By way of derogation from point (b) of the first subparagraph, the labelling elements marked with an asterisk in Annex III do not have to be duplicated on the physical label.

4.   Where EU fertilising products are made available to end-users on the market without packaging, they shall be accompanied by the labelling elements set out in Annex III in the following form:

(a)

on a digital label; or

(b)

in a leaflet accompanying the EU fertilising product.

5.   Where economic operators provide a digital label in accordance with this Article, they shall ensure consistent labelling in the case of duplication and shall comply with the requirements set out in Articles 11b and 11c.

Article 11b

Requirements for digital labels

1.   The digital label shall include:

(a)

the information required pursuant to Article 6(6) and Article 8(3);

(b)

the CE marking and, where applicable, the identification number of the notified body, in accordance with Articles 17 and 18;

(c)

all the labelling elements required under Annex III, with the exception of the production date and quantity where those elements have been provided on the physical label.

2.   The digital label may include recommendations and best practices for the use of the EU fertilising product.

3.   The information referred to in paragraph 1 shall be provided together in one place and separated from information under paragraph 2 and from any information not provided under this Regulation.

4.   The digital label shall be:

(a)

accessible free of charge;

(b)

easily and directly accessible through all major operating systems and browsers, without a need to register in advance, to download or install applications or to provide a password, and accessible to all potential users in the Union;

(c)

searchable;

(d)

presented in a way that also addresses the needs of vulnerable groups and supports, as relevant, the necessary adaptations to facilitate access by those groups, in particular those consisting of persons with disabilities;

(e)

available for a period of 10 years from the date that the EU fertilising product concerned was placed on the market, including in the event of the insolvency, liquidation or cessation of activity in the Union of the economic operator that created it.

Where the digital label is available in more than one language, the choice of languages shall not be dependent on the geographical location.

5.   The data carrier used for a digital label shall be printed or placed physically on the packaging or, where the EU fertilising products are made available on the market without packaging, on the accompanying document or leaflet, in a way that it is externally visible, legible, and accessible to vulnerable groups, including persons with disabilities, and that allows that data carrier to be processed automatically by digital devices.

Article 11c

Obligations of economic operators providing a digital label

1.   Economic operators providing a digital label shall not track, analyse or use any usage information for purposes other than what is absolutely necessary for providing the relevant information digitally.

2.   At the request of end-users and independently of a purchase, or without such a request where the digital label is temporarily unavailable at the time of purchase, economic operators making EU fertilising products available to such end-users on the market shall provide the information included on the digital label by alternative means and free of charge;

3.   Where EU fertilising products are made available on the market with a digital label in accordance with Article 11a(4), point (a), the economic operator supplying them to end-users shall post the labelling information referred to in Article 11b(1) in a visible place at the point of sale.’

;

(5)

in Article 42, the following paragraphs are added:

‘9.   By 1 May 2027, the Commission shall adopt delegated acts in accordance with Article 44 to supplement Articles 11b and 11c by laying down specific requirements for the digital labelling of EU fertilising products and conditions for fulfilling the obligations of economic operators providing a digital label. Those requirements shall establish, in particular, the types of electronic technical solutions which economic operators can use for providing the digital label, and the alternative means for providing the information referred to in Article 11c(2). When adopting the delegated acts, the Commission shall:

(a)

ensure consistency with other relevant Union acts;

(b)

encourage innovation and the use of state-of-the-art technology;

(c)

ensure technological neutrality by not limiting the choice of technology or equipment, within the bounds of compatibility and interference avoidance;

(d)

ensure that the digital labelling does not compromise the safety of the end-user and the environment;

(e)

ensure that any modification of the digital label does not compromise the ability of market surveillance authorities to verify the content of the label which existed prior to that modification;

(f)

take into account the level of digital readiness among end-users of EU fertilising products;

(g)

take into account the requirement set out in this Regulation to provide the information for a period of 10 years from the date that the EU fertilising product was placed on the market;

(h)

take into consideration the enhancement of the free movement of EU fertilising products in the internal market;

(i)

take into consideration the needs and the capacity of small and medium-sized enterprises to comply with such requirements.

10.   The Commission is empowered to adopt delegated acts in accordance with Article 44 to amend Annex III, as regards the labelling information which economic operators choose to provide on a digital label only in accordance with the derogation set out in Article 11a(3), second subparagraph, in order to adapt that Annex to technical and scientific progress or to the level of digital readiness among end-users of EU fertilising products. When adopting those delegated acts, the Commission shall take into account the need to ensure safety and a high level of protection of human, animal and plant health and the environment.’

;

(6)

the following article is inserted:

‘Article 49a

Evaluation

By 21 October 2031, the Commission shall carry out an evaluation of the digital labelling of EU fertilising products as introduced by Regulation (EU) 2024/2516 of the European Parliament and of the Council  ( *1 ) . As part of that evaluation, it shall assess in particular:

(a)

the impact of digital labelling of EU fertilising products on the proper functioning of the internal market, the level of consumer protection and impact of digital labelling of EU fertilising products on businesses, in particular micro, small and medium-sized enterprises;

(b)

the impact of Article 11a and in particular the extent to which economic operators opted for the use of a digital label.

The Commission shall draw up a report on the main findings and submit it to the European Parliament, the Council and the European Economic and Social Committee. Member States shall provide the Commission with the information necessary for the preparation of that report.

The report shall be accompanied, where appropriate, by a legislative proposal.

( *1 )   Regulation (EU) 2024/2516 of the European Parliament and of the Council of 18 September 2024 amending Regulation (EU) 2019/1009 as regards the digital labelling of EU fertilising products ( OJ L, 2024/2516, 30.9.2024, ELI: http://data.europa.eu/eli/reg/2024/2516/oj ).’

"

(7)

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

(8)

Annex IV is amended in accordance with Annex II 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 .

It shall apply from 1 May 2027.

Schedules & Appendices

ANNEX I

ANNEX I

Annex III to Regulation (EU) 2019/1009 is amended as follows:

(1)

Part I is amended as follows:

(a)

point 1 is amended as follows:

(i)

point (d) is replaced by the following:

‘(d)

instructions for intended use concerning application rates, timing and frequency, and target plants or mushrooms;’;

(ii)

the following point is inserted:

‘(da)

other instructions for intended use than those listed in point (d);*’;

(iii)

point (h) is replaced by the following:

‘(h)

a list of all ingredients above 5 % by product weight or volume, or in the case of products in liquid form by dry weight, in descending order of magnitude;*’;

(iv)

the following points are added:

‘(i)

an identification in accordance with Article 18 of Regulation (EC) No 1272/2008 of any ingredient in the list referred to in point (h) that is a substance or a mixture;*

(j)

the designations of the relevant CMCs as referred to in Part I of Annex II for each ingredient listed in point (h).*’;

(v)

the following paragraph is added:

‘Naturally occurring substances may, in addition to the information requested in point (i), be identified by their mineral names.’;

(b)

the following points are added:

‘12.

Where economic operators provide a digital label in accordance with Article 11a(1) and (2), the data carrier used for that digital label shall be accompanied by the warning: “A physical label must be provided in accordance with Regulation (EU) 2019/1009 before the product is made available to end-users on the market in packaging containing up to 1 000 kg” or by a similar warning.

13.

Where economic operators provide a digital label in accordance with Article 11a(3), second subparagraph, the data carrier used for that digital label shall be accompanied by the statement “More comprehensive information on the product is available online. You can ask your supplier to provide that information by other means.” or by a similar statement.

14.

Where economic operators provide a digital label in accordance with Article 11a(4), the data carrier used for that digital label shall be accompanied by the statement “Information on the agronomic efficiency and the safe handling of the product is available online. You can ask your supplier to provide that information by other means.” or by a similar statement.’;

(2)

Part II is amended as follows:

(a)

the section ‘PFC 1(A): ORGANIC FERTILISER’ is amended as follows:

(i)

in point (d), sub-points (v) and (vi) are replaced by the following:

‘(v)

organic carbon (C org );*

(vi)

dry matter;*’;

(ii)

points (e) and (f) are replaced by the following:

‘(e)

the ratio of organic carbon to total nitrogen (C org /N);*

(f)

production date;*’;

(b)

the section ‘PFC 1(B): ORGANO-MINERAL FERTILISER’ is amended as follows:

(i)

in point 1(d) sub-points (v) and (vi) are replaced by the following:

‘(v)

organic carbon (C org );*

(vi)

dry matter;*’;

(ii)

in point 5 sub-point (ca) is replaced by the following:

‘(ca)

where the declared micronutrients are chelated by chelating agent(s), the pH range guaranteeing acceptable stability;*’;

(c)

the section ‘PFC 1(C)(I)(a): SOLID INORGANIC MACRONUTRIENT FERTILISER’ is amended as follows:

(i)

point 2 is replaced by the following:

‘2.

The granulometry of a solid inorganic macronutrient fertiliser shall be indicated, expressed as % by mass of the product passing through a determined sieve.*’;

(ii)

point 4 is amended as follows:

—

the introductory sentence is replaced by the following:

‘For coated solid inorganic macronutrient fertilisers, the following shall be indicated:’;

—

the following points (-a) and (-aa) are inserted:

‘(-a)

the name of the coating agents;

(-aa)

the percentage of fertiliser coated by each coating agent;*’;

(iii)

in point 8, sub-point (ca) is replaced by the following:

‘(ca)

where the declared micronutrients are chelated by chelating agent(s), the pH range guaranteeing acceptable stability;*’;

(d)

the section ‘PFC 1(C)(I)(b): LIQUID INORGANIC MACRONUTRIENT FERTILISER’ is amended as follows:

(i)

point 1 is replaced by the following:

‘1.

The label shall indicate whether the liquid inorganic macronutrient fertiliser is in suspension or in solution.*’;

(ii)

in point 6 sub-point (ca) is replaced by the following:

‘(ca)

where the declared micronutrients are chelated by chelating agent(s), the pH range guaranteeing acceptable stability;*’;

(e)

the section ‘PFC 1(C)(II): INORGANIC MICRONUTRIENT FERTILISER’ is amended as follows:

(i)

point 1 is replaced by the following:

‘1.

For inorganic micronutrient fertilisers, the following shall be indicated:

—

the declared micronutrients listed by their names and chemical symbols of the declared micronutrients, in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn);

—

the names of their counter-ions when the declared micronutrients are intentionally added.*’;

(ii)

point 2a is replaced by the following:

‘2a.

Where the declared micronutrients are chelated by chelating agent(s), the pH range guaranteeing acceptable stability shall be indicated.*’;

(f)

in the section ‘PFC 1(C)(II)(a): STRAIGHT INORGANIC MICRONUTRIENT FERTILISER’, point 1 is replaced by the following:

‘1.

The label shall indicate the relevant typology, as referred to in the table under PFC 1(C)(II)(a) in Part II of Annex I.*’;

(g)

in the section ‘PFC 2: LIMING MATERIAL’, the fifth indent is replaced by the following:

‘—

reactivity and method of determination of reactivity, except for oxide and hydroxide limes.*’;

(h)

the section ‘PFC 3(A): ORGANIC SOIL IMPROVER’ is amended as follows:

(i)

the first indent is replaced by the following:

‘—

pH;*’;

(ii)

the fifth indent is replaced by the following:

‘—

the ratio of organic carbon to total nitrogen (C org /N).*’;

(i)

the section ‘PFC 4: GROWING MEDIUM’ is amended as follows:

(i)

the second indent is replaced by the following:

‘—

pH;*’;

(ii)

the fourth, fifth, sixth and seventh indents are replaced by the following:

‘—

nitrogen (N) extractable by CaCl 2 /DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; “CAT-soluble”), if above 150 mg/l;*

—

phosphorus pentoxide (P 2 O 5 ) extractable by CaCl 2 /DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; “CAT-soluble”), if above 20 mg/l;*

—

potassium oxide (K 2 O) extractable by CaCl 2 /DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; “CAT-soluble”), if above 150 mg/l;*

—

production date.*’;

(j)

the section ‘PFC 5: INHIBITOR’ is replaced by the following:

‘PFC 5: INHIBITOR

1.

All ingredients shall be declared by product weight or volume in descending order of magnitude.*

2.

The content of the inhibiting compound(s), expressed as % by mass or volume shall be declared.*

3.

The use instructions referred to in point 1(da) of Part I of this Annex shall contain information on:

(a)

the types of EU fertilising products with which the inhibitor may be mixed*, in particular:

(i)

for the nitrification inhibitor referred to in PFC 5(A) in Part II of Annex I, an EU fertilising product in which at least 50 % of the total nitrogen (N) content consists of the nitrogen (N) forms ammonium (NH 4

+ ) and urea (CH 4 N 2 O);*

(ii)

for the urease inhibitor referred to in PFC 5(C) in Part II of Annex I, an EU fertilising product in which at least 50 % of the total nitrogen (N) content consists of the nitrogen (N) form urea (CH 4 N 2 O);*

(b)

the minimum and maximum recommended concentration of inhibiting compound(s) when mixed with a fertiliser prior to its use:

(i)

for the nitrification inhibitor referred to in PFC 5(A) in Part II of Annex I, expressed as a % by mass of the total nitrogen (N) present as ammonium nitrogen (NH 4

+ ) and urea nitrogen (CH 4 N 2 O);

(ii)

for the denitrification inhibitor referred to in PFC 5(B) in Part II of Annex I, expressed as a % by mass of the nitrate (NO 3 -) present;

(iii)

for the urease inhibitor referred to in PFC 5(C) in Part II of Annex I, expressed as a % by mass of the total nitrogen (N) present as urea nitrogen (CH 4 N 2 O).’;

(k)

the section ‘PFC 6: PLANT BIOSTIMULANT’ is replaced by the following:

‘PFC 6: PLANT BIOSTIMULANT

The following information shall be provided:

(a)

physical form;

(b)

production date;*

(c)

expiry date;

(d)

application method(s);*

(e)

effect claimed for each target plant;* and

(f)

any relevant instructions related to the efficacy of the product, including soil management practices, chemical fertilisation, incompatibility with plant protection products, recommended spraying nozzles size, sprayer pressure and other anti-drift measures.*’;

(l)

in section ‘PFC 7: FERTILISING PRODUCT BLEND’, the second paragraph is replaced by the following:

‘Where the fertilising product blend contains one or more plant biostimulants belonging to PFC 6, the concentration of each plant biostimulant in the blend shall be indicated in g/kg or g/l at 20  o C.*’.

ANNEX II

ANNEX II

Part II of Annex IV to Regulation (EU) 2019/1009 is amended as follows:

(1)

in the section ‘MODULE A – INTERNAL PRODUCTION CONTROL’, point 2.2. is amended as follows:

(a)

point (c) is replaced by the following:

‘(c)

the EU declarations of conformity for the component EU fertilising products of the fertilising product blend and a specimen of their physical label or leaflet in accordance with Article 11a and, if the information is provided only on a digital label in accordance with that Article, a specimen of the data carrier of the component EU fertilising products,’;

(b)

point (e) is replaced by the following:

‘(e)

a specimen of the physical label or the leaflet referred to in Article 11a providing the information required in accordance with Annex III and, if the information is provided only on a digital label in accordance with that Article, a specimen of the data carrier,’;

(2)

in the section ‘MODULE A1 – INTERNAL PRODUCTION CONTROL PLUS SUPERVISED PRODUCT TESTING’, point 2.2. is amended as follows:

(a)

point (c) is replaced by the following:

‘(c)

the EU declarations of conformity for the component EU fertilising products of the fertilising product blend and a specimen of their physical label or leaflet in accordance with Article 11a and, if the information is provided only on a digital label in accordance with that Article, a specimen of the data carrier of the component EU fertilising products,’;

(b)

point (e) is replaced by the following:

‘(e)

a specimen of the physical label or the leaflet referred to in Article 11a providing the information required in accordance with Annex III and, if the information is provided only on a digital label in accordance with that Article, a specimen of the data carrier,’;

(3)

in the section ‘MODULE B – EU-TYPE EXAMINATION’, point 2.2 is amended as follows:

(a)

point (c) is replaced by the following:

‘(c)

the EU declarations of conformity for the component EU fertilising products of the fertilising product blend and a specimen of their physical label or leaflet in accordance with Article 11a and, if the information is provided only on a digital label in accordance with that Article, a specimen of the data carrier of the component EU fertilising products,’;

(b)

point (e) is replaced by the following:

‘(e)

a specimen of the physical label or the leaflet referred to in Article 11a providing the information required in accordance with Annex III and, if the information is provided only on a digital label in accordance with that Article, a specimen of the data carrier,’;

(4)

in the section ‘MODULE D1 – QUALITY ASSURANCE OF THE PRODUCTION PROCESS’, point 2.2. is amended as follows:

(a)

point (c) is replaced by the following:

‘(c)

the EU declarations of conformity for the component EU fertilising products of the fertilising product blend and a specimen of their physical label or leaflet in accordance with Article 11a and, if the information is provided only on a digital label in accordance with that Article, a specimen of the data carrier of the component EU fertilising products,’;

(b)

point (e) is replaced by the following:

‘(e)

a specimen of the physical label or the leaflet referred to in Article 11a providing the information required in accordance with Annex III and if the information is provided only on a digital label in accordance with that Article, a specimen of the data carrier,’.