EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, 27.2.2023  
COM(2023) 98 final  
2023/0049 (COD)  
 
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
amending Regulation (EU) 2019/1009 as regards the digital labelling of EU fertilising 
products  
(Text with EEA relevance)  
{SEC(2023)  99 final}  - {SWD(2023)  48 final}  - {SWD(2023)  49 final}  -
 {SWD(2023)  50 final}   EN 1  EN EXPLANATORY MEMORANDUM  
1. CONTEXT  OF THE  PROPOSAL  
• Reasons for and objectives of the proposal  
In 2019,  the European  Parliament  and the Council  adopted  Regulation  (EU)  2019/1009  laying  
down  rules  on the making  available  on the market  of EU fertilising  products1. This Regulation  
replaces  the harmonis ation  rules  on EC fertilisers,  as laid down  in Regulation  (EC)  
No 2003/20032.  
Regulation  (EU)  2019/1009  introduces  labelling  requirements  that are much  more  extensive  
than Regulation  (EC)  2003/2003 . This reflected  new social demands  and concerns,  as well as 
the fact that the new rules  drastically  opened  the EU market  for products  that are innovative  
and unknown,  and therefore  require  better  user information.  However,  overloaded  labels  
cause  two problems:  they are both difficult to read by interested  persons  and difficult  to 
manage for economic  operators.  Providing  a lot of details  on a label  makes  it difficult  to 
identify  the essential  information  and may also need  frequent  updates , thereby  increasing  the 
labelling  costs .  
This proposal  is governed  by the same  general  objectives  as Regulation  (EU)  2019/1009,  
namely  ensure a high level  of protection  for human  health  and the environment  and the well-
functioning  of the internal  market.  In response  to the two problems  identified,  this proposal  
follows  two specific  objectives:  improving  the readability  of labels  and facilitating  their 
management  by economic  operators.   
• Consistency with existing rules in the policy area  
Fertilising products are part of the food chain and  account for  a significant portion of  the price 
of agricultural products. In the 2021 Communication on energy prices3, the Commission 
acknowledged the economic difficulties faced by the energy -intensive fertiliser ind ustry 
following the dramatic increase in  energy prices as of the autumn of 2021. As explained in the 
2022 Communication on food security4, the war of aggression of Russia against Ukraine 
exacerbated the economic difficulties already faced by the industry.  
The current difficult political and economic context  speaks in favour of, firstly, accelerating  
the existing trend of improving the use efficiency of fertilising products and, s econdly, 
streamlining  the costs  of bringing fertilising products to the market . This proposal supports 
both trends in the fertilising products policy.   
                                                 
1 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, OJ L 170, 
25.6.2019, p. 1.  
2 Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 
relating to fertilisers, OJ L 304, 21.11.2003, p. 1 –194. 
3 Communi cation from the Commission to the European Parliament, the European Council, the Council, 
the European Economic and Social Committee and the Committee of the Regions of 13 October 2021 
Tackling rising energy prices: a toolbox for action and support, COM/20 21/660.  
4 Communication from the Commission to the European Parliament, the European Council, the Council, 
the European Economic and Social Committee and the Committee of the Regions of 23 March 2022, 
Safeguarding food security and reinforcing the resilien ce of food systems, COM(2022) 133  EN 2  EN On the first issue, t he more efficient use of, in particular, fertilisers is an important element in 
the Farm to Fork Strategy5, which specifies a target of 50% reduction of nutrien t losses and 
aims to reduce fertiliser use by 20% by 2030. The need to increase the use efficiency is 
reiterated in the 2022 Communication on fertilisers6. Use of digital tools is a key enabler in 
this process, for example in trac king the Gross Nutrient Balance  baselines and targets for 
countries and the collection of data at regional level.  In addition, a better communication of 
product properties by using  digital labels is a step towards optimising instructions for use 
efficiency based on those properti es, which will lead to a better communication of the use 
instructions and avoid over -fertilisation.  
On the second issue, laying down  rules for the voluntary digit isation of labels will lead to cost 
reductions for economic operators in the  medium and long term. It will further streamline the 
labelling process, by avoiding unnecessary costs and reducing packaging waste. This will 
optimise the conditions for bringing fertilisers to the EU market in challenging times.  
This proposal  feeds into the broader digitalisation process of the agricultural secto r, a priority 
for most Member State who signed a  declaration for ‘a smart and sustainable digital future for 
European agriculture and rural areas ’ on 9 April  20197.  
• Consistency with other EU policies  
In the Green Deal8, the Commission announced its intention to address the twin challenge of 
the green and digital transition s. Soon after, the COVID -19 pandemic  radically changed the 
role and perception of digitalisation in our societies and economies and accelerated its pace.  
The 2021 Digital Compass Communication9 maps out a clear path towards a common vision 
and actions for Europe to succeed in the Digital Decade. It puts forward the ’digital by 
default ’ principle and outlines a way ahead for the broad -based digitalisation of society.  
There is a lso a  general trend towards  digitisation of labels  and documents accompanying 
products. Rules are in place for construction p roducts10 and medical devices11 or under 
preparation for batteries12, detergents13, cosmetics14 and hazardous chemicals15.  
                                                 
5 Communication from the Commission to the European Parliament, the Council, the European 
Economic and Social Committee and the Committee of the Regions of 20 May 2020, A Farm to Fork 
Strategy for a fair, healthy and environmentally -friendly food system, COM/2020/381.  
6 Communication from the Commission to the European Parliament, the Council, the European 
Economic and Social Committee and the Committee of the Regions of 9 November 2022, Ensuring 
availability and affor dability of fertilisers, COM/2022/590.  
7 Declaration: A smart and sustainable digital future for European agriculture and rural areas 
(smartagrihubs.eu)  
8 Communication from the Commission to the European Parliament, the European Council, the Council, 
the European Economic and Social Committee and the Committee of the Regions, The European Green 
Deal, COM/2019/640, 11.12.2019.  
9 Communication from the Commission to the European Parliament, the Council, the European Economic and Social 
Committee and the Comm ittee of the Regions, 2030 Digital Compass: the European way for the Digital Decade, 
COM(2021)118, 9.3.2021.  
10 Regulation (EU) No 305/2011 of the European Parliament and of the Council of 9 March 2011 laying down 
harmonised conditions for the marketing of construction products and repealing Council Directive 89/106/EEC, OJ 
L 88, 4.4.2011, p. 5.  
11 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, 
amending Directive 2001/83/EC, Regulation (EC) No 178/20 02 and Regulation (EC) No 1223/2009 and repealing 
Council Directives 90/385/EEC and 93/42/EEC, OJ L 117, 5.5.2017, p. 1.  
12 Proposal for a Regulation of the European Parliament and of the Council concerning batteries and waste batteries, 
repealing Directive  2006/66/EC and amending Regulation (EU) No 2019/1020, COM(2020)798.  
13 Detergents – streamlining and updati ng the EU rules (europa.eu)    
14 EU chemicals strategy for sustainability – Cosmetic Products Regulation (revision) (europa.eu)  EN 3  EN The proposal for a Regulation on Ecodesign for Sustainable Products16 aims to establish a 
Digital Product Passport (DPP).  In the version proposed by the Commission, the passport will 
introduce the mandatory  adoption of digital ways of communicating information about all 
regulated products, including fertilising products. Such information will not cover labelling 
requirements. Therefore, this proposal  complements the measures already proposed for 
digitising other information about  products.  
 2. LEGAL  BASIS,  SUBSIDIARITY  AND  PROPORTIONALITY  
• Legal  basis  
This proposal  has the same legal base as  Regulation (EU) 2019/1009 : Article 114 of the 
Treaty on the functioning of the European Union on the approximation of national rules for 
the establishment and functioning of the internal market.  Although the Commission is 
empowered to amen d the Annexes to Regulation (EU) 2019/1009 , all the amendments 
proposed in this initiative  are included in this proposal in order to ease the adoption process as  
they are linked to each other.  
• Subsidiarity   
The problems caused by overloaded labels of EU fertilising products have a strong cross -
border dimension. Inorganic fertilisers subject to Regulation (EC) 2003/2003 are produced in 
a few EU Member States17 and sold all over the EU. Regul ation (EU) 2019/1009 aims both to 
maintain  these products within its scope and encompass  new products,  which have not yet 
been covered by harmonisation rules , thus increasing their potential on the EU market .  
The extensive labelling requirements laid down in Annex III to Regulation (EU) 2019/1009 
have to be provided on the physical label. P art of the info rmation required  by this Annex is 
subject to frequent changes and, in accordance with the same Regulation, labels of certain 
products have to change before reaching the end -users  (for instance, the label of a fertilising 
product blend will contain all the relevant information about the component EU fertilising 
products  expressed in relation to the final blend ; so, before the blend reached the end -user, 
both the component EU fertilising products and the blend itself had a physical label) . The 
Regulation is d irectly applicable in all Member States. In addition, Member States have the 
obligation not to impede the free movement of EU fertilising products for reasons linked to 
their labelling. Therefore, Member States cannot adopt national measures to improve the  
readability of physical labels or avoid frequent changes  to them .  
Member States could adopt national rules regardi ng minimum standards for digit ising the 
labels , when used on a voluntary basis and in addition to physical labels , given that this issue 
is not yet covered in Regulation (EU) 2019/1009 . Such an approach would unavoidably lead 
to different practices all over the EU and create obstacles in the functioning of the internal 
market. It could lead to inequalities in terms o f potential cost savings and communication of 
information. It would also increase costs for industry to adapt to divergent digital labelling 
requirements in different Member States.  
By contrast , introducing the conditions for the digital label  at EU level  has the added value of 
harmonising the various practices. By creating a level playing field, such an initiative would 
                                                                                                                                                         
15 Chemicals – simplification and digitalisation of labelling requirements (europa.eu)  
16 Proposal for a Regulation of the European Parliament and of the Council establishing a framework for setting 
ecodesign requirements for sustainable products and repealing Directive 2009/125/EC, COM/2022/142, 
30.03.2022.  
17 see footnote 26.  EN 4  EN improve the functioning of the internal market, while ensuring the high standard of protection 
required by Regulation (EU) 2019/1009 . In addition, the decision on which labelling elements  
currently requ ired on the physical label may be provided only digitally  can be made only at 
EU level . 
The benefit of EU action also lies in the existence of potential economies of scale in the 
fertilising products industry. Aligning  digital labelling requirements across the EU could 
facilitate the use of multi -lingual labels and thus support the distribution of products with the 
same label in more than one Member State.  
Therefore, this proposal  on the volu ntary digitisa tion of labels for EU fertilising products  is 
necessary and can efficiently tackle the problems identified.   
• Proportionality  
The initiative does not go beyond what is necessary to achieve the objectives sought. It aims 
to introduce  volunta ry digital labelling for EU fertilising products. Economic operators will 
have the choice of whether to provide the labelling elements on a physical or digital label.  
If a digital label is provided , this proposal lays down general rules to ensure a high level of 
protection for users of  EU fertilising products .   
In the accompanying impact assessment, policy options with various degree s of digit isation 
have been assessed.  The option put forward in this proposal strikes the best balance between 
the interests of various stakeholders. While it opens the possibility of providing  digital labels, 
it maintains on the physical label  of EU fertilising products made available to end -users  the 
most important  information, in response to the readiness of such end -users to rely only on 
digital tool s for having access to information. Following the evolution of the society, the 
number  of labelling elements to be provided only digitally could be further increased , which 
is accounted for in the empowerment laid down in  this proposal .      
3. RESULTS  OF EX-POST  EVALUATIONS,  STAKEHOLDER  
CONSULTATIONS  AND  IMPACT  ASSESSMENTS  
 
• Stakeholder  consultations  
The following consultation activities have been carried out:  
Open p ublic consultation  
The open public consultation confirmed the interest in digital labels both from the industry 
and the users ’ side.  
Over half of respondents (52.1%, N=198) would respond positively or moderately positively 
if some information was removed from the label and could only be obtained digitally . Since 
22.7% did not know/could not answer , the percentage is higher (66.9%)  among those that 
answered . 
Most respondents (N=93, 72%) would implement digital labelling if it was possible.  
The main benefits of a digital label  (N=195) include: the possibility to provide more detailed 
information (14%), being able to provide all the relevant information where the packag ing is 
too small (14%), easy  access to  information (13%), access to up -to-date information (13%) 
and informatio n in additional languages (13%); more relevant/targeted information, 
environmental benefits (19%) and cost savings (8%).  EN 5  EN The main challenges of digital labels (N=200) include: difficulty to access information (24%), 
differences between on -pack and digital information (22%), inequalities for different 
population groups (22%), and increased costs for industry.  
Interviews  
Interviews have been organised to collect information on, in particular, (i) what constitutes 
essential labelling information for various categories of stakeholders,  (ii) labels’ use patterns,  
(iii) the benefits and dis advantages of digital labelling and  (iv) industry labelling practices. 
The large number of interviews with industry stakeholder s and fertilising product users 
revealed that in put from these groups  in relation to  specific labelling inform ation  (e.g. content 
of nitrogen)  was often divergent, varying according to the Product Function Categorie s and 
the types of users in question . Thus, essential information for industry representa tives was not 
the same as for professional and non -professional users.  
This proposal takes into account these divergent needs, and gives priority to ensuring the safe 
use of EU fertilising product s and a high level of protection of human health and the 
environment, by keeping on the physical label of packaged products sold to end -users the 
most important information .  
Targeted survey of stakeholders  
The survey targeted users of fertilising products ( professional and  non-professional), the 
industry (manufac turers, importers  and distributors ) as well as conformity assessment bodies 
and market surveillance authorities  from France, Germany, Italy, Lithuania, Poland, Romania, 
Denmark, and Spain.  
Out of the 755 responses received, non -professional users  (i.e. hobby gard eners, persons 
acting outside the scope of an economic activity)  constituted the largest response group 
(43.6%), followed by professional users (33.5%).  
The targeted survey also revealed the differences in perception as regards the most im portant 
information on the label. While users considered information about safety requirements 
absolutely essential, for manufacturers what was thought to be essential was agronomic 
efficiency.  
When asked which format they prefer to access label informatio n in, most of the professional 
and non -professional users selected physical labels. This confirms the need to keep the most 
important information on the physical label.  
Manufacturers had divergent views  on whether digitalisation in general would save them  
money. 48.4% think that it would provide financial savings (N=49).  
Focus groups  
Eight focus groups were organised with professional and non -professional users from France, 
Poland, Romania and Spain. Participants welcome d the digit isation of the EU fertil ising 
products labels, which was seen as beneficial and a natural transition. Concerns were 
expressed about accentuating  the negative effects of the digital divide.   
 This consultation activity showed the differences in perception between professional and  
non-professional users as regards the importance of various categories of information.  
Agronomic efficiency information (such as content of nutrients) was considered more 
import ant than other types of informa tion by professional users, while after purchas e 
information , such as use instructions or storing conditions,  was not that important as 
‘everybody knew what to do’. Non -professional users, on the contrary, found agronomic 
efficiency information too technical  and thought  that after purchase information was more EN 6  EN import ant. Similarly, professional users were  more interested in information on content, such 
as the list of ingredients , than non -professional users .  
Survey experiment  
The survey experiment explored the effects of lab elling changes on key behaviours among 
professional and non -professional users of fertilising products.  The exercise sought to 
understand the behaviours users act ually exhibit when shown digit ised labels, instead of 
asking participan ts what they think abou t digit isation.  
The survey experiment showed  that professional users are mostly unaffected by changes in 
the amount of information on the physical label when it comes to product application and 
storage. Non -professional users are more sensitive to label s implification than their 
professional counterparts.  
With regards to factors influencing understanding of labels, the ease of interpreting labels 
(self-reported) is significantly positively related to the age of professional and non -
professional users, as well as to their experience of using the fertilising product  in question . 
Less information on labels did not lead to a significant change in how easily information was 
interpreted on the label in question by  either of the two user groups .  
Usability testing  
The unmoderated usability testing exercise tested t he popularity and potential use of various 
digital technologies that could be implemented on the fertilising product labels. Of the 48 
tested individuals, 33 scanned a QR  code  and 26 accessed a URL, making these the most used 
options.  
Expert Group meeting on options for digit isation of labels   
An on -line meeting of the Commission Expert Group on Fertilising  Products took place on 
15 March 2022. The input received from the Members and Observers in the expert group fed 
into the development of the policy options. The expert group welcomed  the categorisation of 
the information and the methodology used for building the various policy options.  
They expressed divergent views on the need to introduce a distinction between non -
professional and professional users . While some pointed to the fact that the two categories of 
users have different behaviours and different needs in terms of labelling, others drew  the 
attention to the increased complexity such a distinction would add to the rules, and to the 
difficulties in implementing  and market surveillance.  
Survey on costs and benefi ts related to various digitisa tion options  
Following the expert g roup meeting,  an online survey to collect data on costs and benefits 
related t o various options for digitisa tion was conducted. The survey had 93 valid responses 
distributed among various stakeholder groups .  
Some 56.3% of respondents (manufacturers, N=32) indicated th at they already provide some 
labelling information digitally. Overall , there was strong support for the proposed general 
rules for  digitisation of labels (N=84).  When comparing the effects of labels under the 
different options on economic, environmental an d social impacts, the general response was 
that the higher the level of digit isation , the greater the positive impacts.  
• Collection and use of expertise   
In analysing the results of the consultation activities  and the impact of various pol icy options, 
the Commission used an external contractor.  EN 7  EN • Impact  assessment  
In performing the impact assessment18, the Commission faced two difficulties. Regulation 
(EU) 2019/1009 is applicable as of 16 July 2022, so no concrete experience in applying the 
new rules was available. In addition, the Regulation lay s down the optional harmonisation of 
EU fertilising products. The choice if to apply the Regulation or not is with the manufacturers 
of the fertilising products. Therefore, it is difficult to estimate  how many manufacturers will 
make such a choice and will maintain it in the coming years.  
The impact assessment received a positive opinion from the Regulatory Scrutiny Board on 
22 July 202219.  
The Commission assessed the impacts of three policy options ( PO): PO1 - development of a 
guidance document only, PO2 - information may be provided digitally for EU fertilising 
products and PO3 - all information is provided digitally for certain categories of products.  
As regards PO2, 5 sub -options have been conside red ( PO2a -PO2e). The level of digit isation 
varies ( ranging from certain information to be provided o n the digital label  to most of the 
information to be provided there ). In some of the sub -options, a distinction is made between 
professional and non -profess ional users. The impacts of PO2a -PO2e are analysed together, as 
only limited differences  have been identified . 
The preferred option is PO2a  comb ined with PO3:  
– PO2a means  the optional digitisation of certain information of the label of EU 
fertilising produc ts, without making a distinction between professional/non -
professional users ;  
– PO3 means  the optional digit isation of all the information for products sold in bulk  
and products not sold to end -users, but to other economic operators . 
While PO2a is the most cautious in terms of the scope of the information to be provided only 
digitally, combining this option with PO3 ensures the objectives are most effectively 
addressed, keeping a balanced approach to the different views of stakeholders .  
Firstly, option 2a implies keeping all the safety related information , as well as the most 
important information on agronomic efficiency, content and information relevant after 
purchase  on the physical label. By reducing the  other type of  information to  be included on 
the physical label, safety information will become more visible thus contributing to the 
objective of protecting the health and the environment. This option takes most into account 
the digital divide. Removing all label information, includi ng safety information, under option 
3 for sales to economic operators is justified by the particular users concerned, which are not 
end-users . The economic operators buy the products to make them available on the market, 
and not to apply them on soils. As regards bulk products, given the nature of the product 
itself, there is no possibility of providing the information on a physical label affixed to the 
packaging, which is the direct way of communicating labelling information. Replacing the 
leaflet with a d igital label is not expected to have a significant impact on the availability of the 
information.  
Secondly, this combined option will reduce labelling costs and will create a level playing field 
between economic operators  as regards the use of digital labe lling. The labelling costs will be 
reduced both by including more languages on the  physical  label and by avoiding frequent 
changes  to it. 
                                                 
18 Link to the summary IA  
19 Link to the opinion  EN 8  EN Lastly, this combined option is easier to apply and enforce, as no distinction is made between 
professional and non -professional users. Such a distinction does not exist in Regulation (EU) 
2019/1009  and would have increased the complexity to the rules and made their 
implementation  more difficult .  
Given the limited evidence base for the costs, a full extrapolation of costs to EU level is 
problematic and risks providing a false picture. Maximum EU -level costs for enterprises 
under PO2 (but also PO3) based on stakeholder survey data would be €0.3m (ra nging from 
€0.1m to € 0.6m) for one -off costs, and €0.1m (ranging from €0. 06m to €0 .4m) for ongoing 
(annual) costs. In practice, the actual costs would most likely be less than these maximum 
costs, as a certain proportion of firms would choose not to provid e digital labelling.  
It should be noted that some costs may additionally be incurred by the economic operator 
opting for digital labelling, in terms of providing the information by alternative means where 
necessary. Although such costs could not be quantif ied, they are expected to be marginal, 
given that product information would only be supplied to small portions of the target markets. 
In the longer term, costs would be offset by savings related to updating physical labels, 
avoiding double labelling and fr eeing space on the physical label for information in more 
languages. In addition, PO3 leads to net benefits estimated at  0.8m  as it introduces full 
digitisation of the labelling requirements for products sold in bulk or products which are not 
sold to end -users. 
In terms of direct impacts of PO2a and PO3 on public authorities, despite positive aspects 
related to the ease of managing and compiling online data, public authorities could require 
some investment in equipment and training to facilitate access to d igital labels.  
The estimates for preferred policy option 2a suggest that a mid -range possible one -off net 
benefits would be negative accruing to all enterprises in EU27 (i.e. €-0.1m , based on the 
assumption that all enterprises that export would gain from  savings associated with reduced 
physical labelling requirements). Annual maximum recurring benefits for PO2a would be 
€0.9m  accruing to all enterprises (EU27). Under option 3, maximum possible one -off net 
benefits woul d also be negative (i.e.  €-0.5m  based  on the same assumptions as for PO2a).20  
However, annual maximum recurring net benefits for PO3 would be €3m  accruing to all 
enterprises21 (EU27).  
The preferred option is expected to have environmental benefits, by reducing packaging 
waste. Such benefits co uld not be quantified.  
No negative social impact is expected as under PO2a, the information found essential by 
various categories of users is maintained on the physical label. On the contrary, the readability 
of the physical label is expected to be improv ed, by moving various technical details  to the 
digital label . In addition, users will be able to take full advantage of the various possibilities 
created by digitalisation in terms of accessibility and searching specific information in digital 
format.  
• Regulatory  fitness  and simplification  
This proposal  aims to simplify the compliance with the labelling requirements under 
Regulation (EU) 2019/1009  and thus to reduce the burden on economic operators, without 
                                                 
20 One-off costs are expected to remain the same under PO2 and PO3. Please refer to Annex 4 for a full 
breakdown of cost and benefit calculations.  
21 Relevant to PO3 14% of all enterprises are assumed to only provide products in bulk or products which 
are sold to industrial users (e.g. blenders).  EN 9  EN jeopardising the main objectives of the Regulat ion, including the protection of human health 
and the environment . 
This proposal  directly contributes to the REFIT scoreboard (Areas 13. Chemicals legislation 
(other than REACH)), by using digital tools  to communicate information on EU fertilising 
products . Reaping the benefits of the digital age will result in potential burden reduction for 
SMEs, improved enforcement and compliance, reinforcing cooperation between competent 
authorities, including customs and market surveillance authorities .  
The digit isation of the label remains optional. So, no specific measures are needed for small 
and medium ent erprises , which are free to choose the right moment to do this change, if at all.  
5. OTHER  ELEMENTS  
• Implementation  plans  and monitoring,  evaluation  and reporti ng arrangements  
In the evaluation performed in accordance with Article 49 of Regulation (EU) 2019/1009, t he 
Commission will also assess how this specific intervention has performed (or is working), and 
draw preliminary conclusions. This will be the first opportunity to assess whether there were 
unintended or unexpected effects.  
Subsequently, the Commission will be monitoring if the EU intervention remains fit for its 
purpose, should be adjusted for greater effectiveness, relevance and coherence, or should 
simply be repealed.  
• Detailed  explanation  of the specific  provisions  of the proposal  
This proposal introduces the voluntary digit isation of the labels of EU fertilising products. 
The choice is wit h the manufacturers, importers or distributors of EU fertilising products.  
It is proposed to allow economic operators to provide all the labelling elements  required under 
Annex  III to Regulation (EU) 2019/1009 only in a digital format in the following two  
situations: the EU fertilising products are sold without a packaging , or the EU fertilising 
products are sold to economic operators (which are not end -users of the products).  
The economic operators opting for the digital labelling of EU fertilising products supplied to 
end-users  in packaging  will have to provide also a physical label, containing the most 
important information . The physical label will contain  all the information concerning the 
protection of human health and the environment, as well as  the most important information on 
the agronomic efficiency and content of the product, or information used after purchase.  
Once economic operators cho ose to provide digital labels, the proposal lays down the gen eral 
rules regarding the digit isation of labels. In particular , the economic operators will have to 
ensure that the digital label can be accessed free of charge  and is easily accessible all over the 
EU, and they will have to take into account the needs of vulnerable population groups. The 
information on digital labels is also to be provided by alternative means, where needed.  
The proposal contains a Commission empower ment  to supplement  the general digital 
labelling requirements and further adapt Annex III by deciding which labelling elements  
could be provided digitally  when EU fertilising products are made available to end -users in  
packaging , depending on the evolution of the society .  
 EN 10  EN 2023/0049 (COD)  
Proposal for a  
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL  
amending Regulation (EU) 2019/1009 as regards the digital labelling of EU fertilising 
products  
(Text with EEA relevance)  
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,  
Having regard t o the Treaty on the Functioning of the European Union, and in particular 
Article  114 thereof,  
Having regard to the proposal from the European Commission,   
After transmission of the draft legislative act to the national parliaments,  
Having regard to the opi nion of the European Economic and Social Committee1,  
Acting in accordance with the ordinary legislative procedure,  
Whereas:  
(1) Annex III to Regulation (EU) 2019/1009 lays down the labelling requirements 
applicable to EU fertilising products . The informat ion referred to in Annex II I is to be 
provided on  a label in a physical form attached to that 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 that packaging  (‘physical label ’). Products without a 
packaging are accompanied by a leaflet. The labelling requirements concern  various 
parameters linked to the agronomic efficiency of EU fertilising products (e.g., content 
of nutrients in a fertiliser)  and the content of such products (e.g., quantity) . The 
labelling requirements also cover information needed for the protection of human 
health and the environment when using EU fertilising products (e.g., information 
needed for the correct application of Council  Directive 91/676/EEC2) and information 
needed for the correct handling and use of such products after purchase ( e.g., 
information on storage conditions).  
(2) The form in which  EU fertilising products are labelled  in accordance with  Regulation 
(EU) 2019/1 009 should be ad apted to technological and societal chang es in the field of 
digitalisation.  
(3) Providing information o n a label in a digital form (‘digital label’) has clear benefits. 
Digital  labelling c an improve the communication of labelling information  both by 
avoiding overcrowded physical label s and by allowing users to rely on various reading 
options  available only for digital formats,  such as increased fon t, automatic search, 
loud speakers or translation into other languages . In addition , digital labelling of EU 
                                                 
1 OJ C , , p. .  
2 Council Directive 91/676/EEC of 12 December 1991 concerning the pr otection of waters against 
pollution caused by nitrates from agricultural sources  (OJ L 375, 31.12.1991, p. 1 ). EN 11  EN fertilising products contributes to the ongoing progress with regard to digitalisation of 
the European agricultur al sector  and can facilitate the reporting obligations of farmers 
regarding the use of such products. Digital label ling can also lead to a more efficient 
management of the labelling obligations by economic operators , by facilitating the 
update of labelling information  and permitting a more targeted information to users . In 
addition, digital labelling can contribute to reducing labelling costs all along the 
supply chain, given that the labels of EU fertilising products may be changed 
following a transaction between economic operators, before reaching end -users,  
(4) However, digital labelling c an also create new challenge s for the vulnerable 
population groups , in particular persons  with no , or insufficient , digital skills  or 
persons with disabilities,  and thus accentuate the digital divide . Therefore,  digital 
labelling should be introduced in Regulation (EU) 2019/1009, und er certain 
conditions, taking into account  the need to ensure a high level of protection of human 
health and the environment , and the digital readiness .  
(5) Economic operators  should remain free to choose if to provide a digital or physical 
label. This wi ll ensure that  such economic operators hav e flexibility to opt for the rules 
most appropriate to their situation. It is particularly important not to create unjustified 
costs for small and medium -sized  enterprises for which digital labelling might be 
challenging , given the reduce d volumes or types of EU fertilising products.  
(6) The choice to provide a digital label lies primarily with manufacturers and importers, 
who are responsible for fulfilling the labelling requirements set out in Annex III  to 
Regulation (EU) 2019/1009 . Nevertheless, to maximise the use of digital labels  and 
thereby improve  the communication of information to users, distributor s should also  
have the possibility to digit ise the label of EU fertilising products that they make 
available on the market, based on the information already provided by the 
manufacturer . The extent of digital labelling should depend on two factors: if the EU 
fertilising products are made available to economic operators or to end -users  and if the 
products are provided with or without a packaging .  
(7) Economic operators should be allowed to provide all the labelling elements referred to 
in Annex III of Regulation (EU) 2019/1009 in a digital label only for the EU fertilising 
products sup plied to other economic operators , with or without a packaging . The use 
of digital labels in such cases can reduce the labelling costs in the supply chain. 
Importers or distributors will have the  possibility to affix a physical label to the EU 
fertilising product directly in the official languages needed for their specific situation. 
In addition, labelling costs can be avoided in case of blending, packaging or re -
packaging of EU fertilising products, since the products c an be labelled with a 
physical label only once, before reaching end -users. As products are supplied to 
economic operators, the communication of information  to end -users is not affected . 
Where the economic operators choose to provide, in addition to a digital label, a 
physical label, they shou ld be free to decide which labelling elements to include in that 
physical label.  
(8) Physical labels  remain the preferred way of obtaining information for end -users  as by 
being affixed to packaging  such physical labels  offer immediate access to information . 
In addition, t he vast majority of EU fertilising products available on the market  are 
used by professional users, such as farmers . While professional users are well 
accustomed with fertilising products and often rely on consultancy for their 
fertilisation plans, they tend to belong to more advanced  age groups, with more 
reduced digital skills .  EN 12  EN (9) Whe re economic operators opt for digital labelling of EU fertilising products supplied 
to end -users in a packag ing, they should therefore ensure th at a minimum set of 
information is also available on  the physical label. In this context and with regard to 
other rules specific to products made available in a packaging, a packaging should 
contain no more than 1000 kg in coherence with Commission Regulat ion (EU) No 
142/20113. Products supplied in a packaging exceeding this limit should be considered 
as being supplied without a packaging for the purpose of Regulation (EU) 2019/1009 . 
This will also address the  challenges that vulnerable population groups may face.  The 
specific information that economic operators should be allowed to provide  only on a 
digital label should therefore reflect the current state of the digitalisation of the society  
and the particular situation of the users of EU fertilising produc ts. In order to enable 
all end -users to make informed choices before buying EU fertilising products and to 
ensure the safe handling and use of such products by all groups of end -users, labelling 
information concerning the protection of human health and the  environment, as well as 
minimum information on the agronomic efficiency of the EU fertilising products  and 
on their content and use , should always be provided on the physical label. Regulation 
(EU) 2019/1009  should clearly indicate which information may b e provided only 
digitally .  
(10) For EU fertilising products supplied without packaging , the economic operators are to 
provide the labelling elements  in a leaflet . The leaflet, contrary to physical labels, ha s 
no physical link to the product itself  and the refore do es not offer immediate access to 
the information relevant to the product  when handling it . Providing  the same labelling 
elements in digital format would imply an adjustment of the way the information is 
retrieved  without  creating  significant  risks  to users .  Economic operators should 
therefore be allowed to provide all the labelling elements referred to in Annex III of 
Regulation (EU) 2019/1009 in a digital label only for the EU fertilising products 
supplied without packaging.  Where the economic operators choose  to provide , in 
addition to a digital label,  a physical label, they should be free to decide which 
labelling elements to include in that physical label.   
(11) To ensure a level playing field among economic operators making avai lable EU 
fertilising products on the market, and to protect the end -users of such products, 
requirements for digital labelling should be laid down.  
(12) In order to ensure that users receive all the labelling elements on the digital label and 
will not nee d to compile the information both from a physical and a digital label, 
economic operators using a digital label should be required to include all such 
labelling elements  in that label , even if they are  also included on the physical label . 
The digital label  should also contain information allowing end-users to identify and 
contact the manufacturer of the EU fertilising products, as this is an essential 
information and providing it digitally will facilitate the link between the product and 
the digital label. In addition, given that fertilising products are also  placed on the 
market as non -harmonised produc ts, it is important to include o n the digital label  the 
CE-mark  and any corresponding reference to a notified body, so that end -users can 
deduce only from using the digital label that the product is marketed in accordance 
                                                 
3 Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 
1069/2009 of the European Parliament and of the Council laying down health rules as regards animal 
by-products and derived products not intended for human consumption and implementing Council 
Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border 
under that D irective, OJ L 54, 26.2.2011, p. 1.  EN 13  EN with Regulation (EU) 2019/1009. However, t o facilitate the update of certain 
information to be pr ovided by the manufacturers, which changes frequently and is not 
used on a daily basis by end -users ( more precisely,  the batch number and the 
production date), the manufacturers should have the choice to provide the information 
either physically or digital ly.  
(13) Since digital labels, similarly to physical labels, are a means of providing mandatory 
information on EU fertilising products to users, e conomic  operators should ensure free 
access to digital labels. In addition, and in order to improve the chanc es that users will 
in practice retrieve the information, the information provided on the digital label 
should be easily access ible. Economic operators should not mix the information 
required by Regulation (EU) 2019/1009  with other information  not requested  by 
Regulation (EU) 2019/1009 , such as marketing or commercial  statements . Digital 
space has no space limitations typical for physical labels affixed to the packag ing. It is 
therefore important to keep the labelling elements  provided in accordance with 
Regulation (EU) 2019/1009  concentrate d in one place, so that they are  not difficult to 
find among various other information  which economic operators might provide . 
Economic operators should also ensure that digital labels are presented in a way that 
takes into account the needs of vulnerable population groups , to further reduce the 
challenges such groups may face .  
(14) Taking into account both the interest of users to have access to information about EU 
fertilising products with a relatively long shelf life and the interest of economic 
operators to avoid unnecessary costs , economic operators should ensure that the digital 
label is available for  a period of 5 years from the moment the EU fertilising product  is 
placed  on the market.   
(15) In order to reduce any potential risks caused by the unavailability of the digital label  to 
vulnerable population groups , in particular as regards EU fertilising products supplied  
without packaging  to end -users, wh ere all the labelling elements may be provided 
digitally, economic operators should be responsible for providing the labelling 
elements by alternative means to end -users,  upon request. W henever  the digital label  is 
temporarily unavailable , the information should be provided even without a request .  
(16) The requirements for the technical documentation set out in Annex IV to Regulation 
(EU) 2019/1009 should be adjusted to take into account the introduction of digital 
labels. In addition,  taking into account the possibility to provide only a digital label for  
EU fertilising products made available to blenders,  to facilitate market surveillance, 
the technical documentation of fertilising products blends should include a specimen 
of the information provided under Annex III to Regulation (EU) 2019/1009 on the 
component EU fertilising products .  
(17) In order to keep Regulation (EU) 2019/1009 up -to-date to technical progress, new 
scientific evidence and the evolution of the digitalisation of the society , the power to 
adopt acts in accordance with Article 290 of the Treaty on the Functioning of the 
European Union should be delegated to the Commission in respect of supplementing 
the requirements for digital labelling and amending Annex III with regard to w hich 
labelling elements  economic operators making available on the market EU fertilising 
products in a packaging to end -users may provide  on a digital label only . It is of 
particular impo rtance that the Commission carries  out appropriate consultations duri ng 
its preparatory work, including at expert level, and that those consultations are EN 14  EN conducted in accordance with the principles laid down in the Interinstitutional 
Agreement of 13 April 2016 on Better Law -Making4. In particular, to ensure equal 
participat ion in the preparation of delegated acts, the European Parliament and the 
Council receive all documents at the same time as Member States' experts, and their 
experts systematically have access to meetings of Commission expert groups dealing 
with the prepar ation of delegated acts.   
(18) When setting out more detailed rules for digital labelling, the Commission should pay 
particular attention to other U nion rules  on the provision of information about products  
or substances and mixtures  in a digital format. It  should be possible to access all the 
information requested by various U nion rules in one digital space, so that the users 
have easy access to all the information needed.  
(19) When deciding which labelling elements may be provided only digitally by  economi c 
operators making available on the market EU fertilising products in a packaging to 
end-users , the Commission should take into account the level of digital readiness 
among users of EU fe rtilising products  and the need to keep  the use of such products 
safe for human health and the environment.   
(20) Regulation (EU) 2019/1009  should therefore be amended accordingly.  
(21) Given that this Regulation introduces  the possibility of providing all or part of the 
labelling requirements in Annex III on ly in digital labels,  its application  should be 
deferr ed to provide for enough  time for the development of the supplementing 
requirements concerning the digital labelling.   
(22) The specific objectives of this Regulation, namely to improve the readability of the 
labels of EU fertilising products and to facilitate the management of such labels by the 
economic operators, cannot be sufficiently achieved by the Member States. Since they 
can rather, by reason of their scale and effects, be better achieved at Uni on level, the 
Union may adopt measures, in accordance with the principle of subsidiarity as set out 
in Article 5 of the Treaty on European Union. In accordance with the principle of 
proportionality, as set out in that Article, by introducing a possibility to use digital 
labelling  for certain information , this Regulation does not go beyond what is necessary 
in order to achieve th ose objective s, 
HAVE ADOPTED THIS REGULATION:  
Article 1  
Regulation (EU) 2019/1009 is amended as follows:  
(1) Article 2  is amended as follows:   
(a) the following point (10a)  is inserted:  
‘(10a) “ packag ing” means a sealable receptacle  holding not more than 1 000 
kg;’;  
(b) the following point (16a)   is inserted:  
‘(16a) “data carrier”  means  a linear bar code symbol, a two -dimensional 
symbol or other automatic identification data capture medium that can be read 
by a device ;’; 
                                                 
4 OJ L 123, 12.5.2016, p. 1.  EN 15  EN (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  either  
physically  on the packaging or the accompanying document , digitally, or both . 
Where th e information is provided digital ly, the requirements set out for digital 
labels in Article 11b  and the obl igations 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 re placed 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 
set out in Articl e 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 and intelligible ; 
(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) accessib le for inspection purposes when the EU fertilising product is  
 made available on the market.’;  
(4) the following Article s 11a, 11b and 11c  are inserted:  
 ‘Article 11a  
Forms of l abelling  
1. Where EU fertilising products are made available on the market in a packaging to  
economic operators, they shall be accompanied by the labelling elements set out in 
Anne x 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 that 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 that 
packaging ( “physical label ”).  EN 16  EN 2. Where EU fertilising products are made available on the market without packaging  
to economic operators, they shall be accompanied by  the labelling elements  set out in 
Annex III  in the fo llowing form : 
(a) on a digital label ; or 
(b) on a leaflet accompan ying the EU fertilising product.  
3. Where EU fertilising products  are made available on the market in a packaging to 
end-users, 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 w ay of derogation from point b , 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 on the market without packaging 
to end -users, 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 comply with the requirements set out in Articles 11b and 11c.  
Article 11b  
Requirements for digital label s 
1. The digital label shall include:   
(a) the information required pursuant to Article 6(6);   
(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  where that date has been provided on the physical 
label .  
2. The information  referred to in paragraph 1 shall be provided  in one place and 
separated from  any information  not provided under  this Regulation .  
3. The digital label shall be :  
(a) accessible free of  charge;  
(b) easily  and directly  accessible,  without a need to regist er in advance, to 
download or install applications or to provide a password;accessible to 
all potential users in the U nion;  
(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 ;  EN 17  EN (e) available for a period of 5 years  from the moment the  EU fertilising  
product is placed on the market, including in case of an insolvency, a 
liquidation or  a 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 
language s shall not be dependent on the geographical location . 
4. A 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 a packaging, on the accompanying document or leaflet, visibly, legibly and 
in a way that allows it 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. Upon request by the end -users, or without such request where  the digital label is 
temporarily unavailable at the time of purchase, economic operators making 
available on the market EU fertilising products to  such end-users shall provide the 
information  included  on the digital label , by alternative means  and free of  charge .’; 
(5) in Article 42 , the following paragraphs  9 and 10 are added : 
‘9. By [OP: please insert the date = the fir st day of the month following 30  months 
after the date of entry into force  of this Regulation ], the Commission shall adopt  
delegated acts in accordance with Article 44 to supplement Article s 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  solution s which economic operators may use  for providing the digital label , 
and the alternative means  for providing the information  referred to in Article 11 c(2). 
When  adopting the delegated  acts, the Commission shall :  
(a) ensure coherence with other relevant Union acts;   
(b) encourage innovation ;   
(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) take into account the level of digital readiness among end-users of EU 
fertilising products.     
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  may provide  on a digital  label only  in accordance with Article 11a(3 ) point 
(b), 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 the EN 18  EN delegated acts, the Commission shall take into account the need to ensure a high 
level of protection of human health and the environment.’;  
(6) Annex III is amended in accordance with Annex I to this Regulation;  
(7) 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  [OP: please insert the date = the first day of the month following 30 
months after the date of entry onto force of this Regulation ]. 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
For the European Parliament  For the Council  
The President  The President  