COMMISSION STAFF WORKING DOCUMENT Accompanying the documents Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2024/2865 as regards dates of application and transitional provisions
Date: 2025-07-08
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: administrative formalities, chemical product, classification, consumer information, cosmetic product, dangerous substance, fertiliser, labelling, market approval, packaging, product safety

EN 

  EN 

   EUROPEAN COMMISSION  Strasbourg, 8.7.2025  SWD(2025) 531 final  COMMISSION STAFF WORKING DOCUMENT Accompanying the documents Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 as regards simplification of certain requirements and procedures for chemical products Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2024/2865 as regards dates of application and transitional provisions          {COM(2025) 531 final} - {COM(2025) 526 final}  
 
 
CONTENTS 

A. 

Introduction ............................................................................................................................. 3 

B.  The EU chemical legislation ................................................................................................... 4 

1.  Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Hazardous 
Chemicals (CLP) ......................................................................................................................... 5 

2.  Regulation (EC) No 1223/2009 on cosmetic products (CPR) ............................................ 5 

3.  Regulation (EU) 2019/1009 on EU Fertilising Products (FPR) ......................................... 7 

C.  Main issues at stake and the ways to address them ................................................................ 8 

1. 
Issues  and  proposed  amendments  to  Regulation  (EC)  No  1272/2008  on  Classification, 
Labelling and Packaging of Hazardous Chemicals (CLP) ......................................................... 8 

a.  Mandatory formatting requirements, including minimum font sizes and line spacing for 
the labelling of hazardous chemicals introduced by the Regulation 2024/2865 .................... 9 

b.  Rules on advertisements ................................................................................................. 24 

c.  Other  areas  where  stakeholders  called  for  simplification  which  are  addressed  in  the 
Commission proposal............................................................................................................ 29 

d.  Other areas where stakeholders called for simplification which were not addressed by the 
Commission proposal............................................................................................................ 33 

2. 
Issues and proposed amendments to Regulation (EC) No 1223/2009 on cosmetic products 
(CPR) ........................................................................................................................................ 36 

a.  Lack of clear and comprehensive procedure for the addition of colorants, preservatives, 
and UV filters to Annexes IV–VI of the CPR ....................................................................... 36 

b.  Article 15: CMR substances – procedure for prohibition and requesting derogation from 
the ban ................................................................................................................................... 37 

c.  Prenotification requirement for products containing nanomaterials (Article 16) ........... 47 

d.  Publication of the glossary of cosmetic ingredients in the Official Journal of the EU ... 48 

e.  Reporting on market surveillance actions (Article 22) ................................................... 49 

Issues  and  proposed  amendments  to  Regulation  (EU)  2019/1009  on  EU  Fertilising 
3. 
Products (FPR) .......................................................................................................................... 53 

a.  REACH registration of substances in EU fertilising products ....................................... 53 

b.  Assessment of microorganisms in plant biostimulants ................................................... 59 

c.  Digitalisation ................................................................................................................... 63 

d.  Removal of the ‘unbundling clause’ ............................................................................... 66 

e.  Other areas where stakeholders called for simplification ............................................... 67 

D.  Overall conclusions ............................................................................................................... 69 

Page 1 of 109 

 
 
 
 
ANNEX I ...................................................................................................................................... 71 

ANNEX II ..................................................................................................................................... 81 

ANNEX III.................................................................................................................................... 89 

ANNEX IV ................................................................................................................................... 99 

ANNEX V ................................................................................................................................... 106 

Page 2 of 109 

 
 
 
 
 
 
 
A.  INTRODUCTION 

The  chemical  sector  holds  a  critical  position  in  the  European  Union’s  economic  architecture, 
forming the backbone of numerous industrial ecosystems and playing a pivotal role in innovation, 
employment, and sustainable growth. In the context of Europe’s twin transition towards climate 
neutrality and digital transformation, maintaining a robust and competitive chemicals industry is 
essential for safeguarding the EU’s strategic autonomy and global economic standing. 

Regulatory burdens  are  one of the two top problems  named by businesses operating in  the EU 
when it comes to the investment climate. The analysis provided by the high-level reports of Enrico 
Letta1  and  Mario  Draghi  put  the  reduction  of  the  regulatory  burdens  and  simplification  of  EU 
legislation among the top priorities. Overregulation is seen by more than 60% of EU companies 
as  an  obstacle  to  investment,  with  55%  of  SMEs  flagging  regulatory  obstacles  and  the 
administrative burden as their greatest challenge2. 

The European Commission’s Better regulation agenda3 seeks to enhance the competitiveness of 
EU businesses by ensuring that legislation achieves its goals efficiently, without placing undue 
burdens on stakeholders. 

President von der Leyen in her political guidelines for the European Commission’s 2024–2029 
mandate4  outlined  a  vision  focused  on  driving  sustainable  prosperity  and  strengthening 
competitiveness across Europe, emphasising the need to make business easier and faster. Central 
to this vision are efforts to streamline business operations and further integrate the Single Market. 
To that end, each Commissioner is tasked with focusing on reducing administrative burdens and 
simplifying implementation and to stress-test the EU acquis. This is operationalised in the mission 
letters to all Members of the College, asking them to ensure that existing rules are fit-for-purpose 
and to focus on reducing administrative burdens and simplifying legislation. 

The  political  commitment  to  lighten  the  regulatory  burden  for  people,  businesses  and 
administrations in the EU to boost prosperity and resilience of the EU is further reaffirmed in the 
Competitiveness Compass for the EU5. The Compass identifies the policy changes that are needed 
for the EU to step up to the new realities and develop novel ways of working together to increase 
the speed and quality of decision-making. A pivotal point to achieve this will be the simplification 
of the regulatory environment and the reduction of burden. The Compass, therefore, sets the target 

1 

2  

3  

4  

5  

a 

of 

The 

than 

more 

2024, 

Letta, 

Much 

future 

market, 

Draghi, 

available 

competitiveness, 

E. 
https://www.consilium.europa.eu/media/ny3j24sm/much-more-than-a-market-report-by-enrico-letta.pdf. 
M. 
European 
https://commission.europa.eu/topics/eu-competitiveness/draghi-report_en#paragraph_47059, p. 18. 
Better  regulation:  Joining  forces  to  make  better  laws,  COM(2021)  219  final,  available  at:  https://eur-
lex.europa.eu/legal-content/EN/TXT/?uri=COM:2021:219:FIN. 
Political Guidelines for the next European Commission 2024-2029, available at: 
https://commission.europa.eu/document/download/e6cd4328-673c-4e7a-8683-f63ffb2cf648_en.  
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,  COM  (2025)  30  final: A 
Competitiveness  Compass 
at  https://commission.europa.eu/topics/eu-
competitiveness/competitiveness-compass_en. 

the  EU, 

available 

available 

2024, 

for 

at: 

at: 

Page 3 of 109 

 
 
 
 
of cutting administrative burden by at least 25% for all companies and at least 35% for small and 
medium-sized enterprises (SMEs) without undermining the respective policy goals. 

The  Single  Market  Strategy  further  reiterated  the  commitment  for  more  simplification  and 
readiness  for  immediate  actions  to  reduce  red  tape  and  make  things  simple.  The  Strategy 
highlighted  the  aim  for  simplification  leading  to  lower  costs,  higher  productivity,  and  a  better 
functioning of the Single Market, while maintaining the ambition on the climate and sustainability, 
and social responsibilities. It also underlined the need to ensure that rules on labelling balance the 
need to be clearly understood by consumers with the need to reduce market barriers and burden 
for industry6. 

Following  those  commitments,  this  initiative  aims  at  simplifying  and  streamlining  certain 
requirements  and procedures  under Regulation  (EC) No 1272/20087 on classification, labelling 
and packaging of substances and mixtures, Regulation (EC) No 1223/2009 on cosmetic products 
and Regulation (EU) 2019/10098 laying down rules on the making available on the market of EU 
fertilising products, which were identified as particularly burdensome by industry and authorities. 
These provisions would benefit from regulatory streamlining and modernisation, that will improve 
the effectiveness of chemical legislation, while at the same time increasing the cost-effectiveness 
and overall competitiveness of the EU chemicals industry and related sectors. 

A more predictable and less burdensome regulatory landscape is indispensable for enhancing the 
chemicals  sector’s  competitiveness  and  facilitating  its  green  transition. A  smarter  approach  to 
regulation – one that removes redundant requirements, avoids duplication, and ensures consistency 
– will help unlock the full potential of the chemical industry as a driver of sustainable European 
prosperity, without compromising on the level of protection of human health and the environment. 

B.  THE EU CHEMICAL LEGISLATION 

The  EU  has  a  comprehensive  legal  framework  on  chemical  substances,  on  their  own  and  in 
mixtures,  as  well  as  on  products  containing  chemical  substances  and  mixtures. Together,  these 
rules aim to ensure the safety of EU citizens and the protection of the environment, while enabling 
the  free  movement  of  chemical  substances  and  products  on  the  internal  market.  The  pieces  of 
chemical legislation targeted by this initiative are briefly presented in this chapter. 

6  

7  

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, COM (2025) 500 final: The 
Single Market: our European home market in an uncertain world, A Strategy for making the Single Market 
simple,  seamless  and  strong,  available  at:  https://single-market-economy.ec.europa.eu/publications/single-
market-our-european-home-market-uncertain-world_en. 
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, 
ELI: http://data.europa.eu/eli/reg/2008/1272/oj). 
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, ELI: http://data.europa.eu/eli/reg/2019/1009/oj). 

Page 4 of 109 

 
 
 
 
1.  Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Hazardous 

Chemicals (CLP) 

The objective of Regulation (EC) No 1272/2008 (the CLP regulation) is to ensure a high level of 
protection of health and the environment, as well as the free movement of substances, mixtures 
and  certain  articles.  The  CLP  regulation  implements  in  the  EU  the  United  Nations'  Globally 
Harmonised System (GHS) and establishes legally binding hazard identification and classification 
rules. It also contains detailed labelling and packaging rules. Together with other EU legislation, 
it sets up rules to ensure that hazardous chemicals are safe when placed on the market.  

The CLP regulation requires economic operators  to  classify, label  and package their hazardous 
chemicals  appropriately before placing  them on the  market  and  contains  rules  in  this regard. A 
classification can be harmonised and applied across the EU to all duty holders. Such classification 
is adopted at EU level according to a regulatory procedure. Where harmonised classification does 
not exist, economic operators have to assess and classify their hazardous chemicals according to 
available  data  (‘self-classification’).  The  hazard  classification  determines,  amongst  others,  the 
appropriate labelling and packaging of the chemicals in the supply chain, in particular to protect 
workers, consumers and the environment.  

In  addition,  the  CLP  regulation  lays  down  notification  requirements  for  economic  operators.  It 
requires  manufacturers  and  importers  to  submit  classification  and  labelling  information  for  the 
hazardous substances they are placing on the market to the Classification and Labelling Inventory 
managed by the European Chemicals Agency (ECHA), which then publishes certain information 
submitted to the inventory. Furthermore, the CLP regulation lays down harmonised requirements 
for submission of the information related to emergency health response and preventative measures, 
that duty holders placing hazardous mixtures on the market should submit to the appointed bodies 
in the Member States (so-called ‘Poison centres notifications’). 

The  CLP  regulation  was  recently  amended  by  Regulation  (EU)  2024/28659,  which  introduced 
numerous legislative changes aiming at improving communication of hazard-related information 
to users of chemicals, ensuring adequate classification rules as well as addressing identified legal 
gaps and uncertainties. 

2.  Regulation (EC) No 1223/2009 on cosmetic products (CPR) 

The CPR, adopted by the European Parliament and the Council on 30 November 2009, replaced 
the Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member 
States relating to cosmetic products.  

The CPR applies to all cosmetic products made available on the EU market either manufactured 
in  the  EU  or  entering  the  EU  market  from  third  countries.  It  comprehensively  harmonises  the 
human health protection rules in the Union to achieve an internal market for cosmetic products.  

9  

Regulation (EU) 2024/2865 of the European Parliament and of the Council of 23 October 2024 amending 
Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures (OJ L, 
2024/2865, 20.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2865/oj). 

Page 5 of 109 

 
 
 
 
The  CPR  impacts  manufacturers,  importers,  distributors,  and  consumers  by  ensuring  that  all 
cosmetic products in the EU are safe for use and that the rules for selling them are consistent across 
countries. The key aspects of the CPR include: 

•  Upholding the unconditional free movement in the EU of cosmetic products complying 
with the CPR by requiring the member states not to refuse, prohibit or restrict the making 
such cosmetic products available on the EU market. 

•  The almost automatic prohibition of the ingredient or substance from the use in cosmetic 
products where such an ingredient/substance had received a harmonised classification as a 
carcinogenic, mutagenic and reprotoxic (CMR) substance unless the request for derogation 
was introduced, and the substance was assessed and found safe, while meeting the other 
derogation criteria. 

•  The  obligation  to  pre-notify  cosmetic  products  containing  nanomaterials  in  the  EU’s 

cosmetics database (CPNP) before such products are placed on the EU market. 

•  An authorisation of substances used as colorants, preservatives or UV filters. 
•  The obligation to notify to the Commission, through the EU's CPNP, each cosmetic product 

placed on the market. 

•  The introduction of a harmonised system for the safety assessment of cosmetic products, 
which  must  be  carried  out  by  a  qualified  person  and  consider  the  product's  formula, 
packaging, and labelling. 

•  The ban on animal testing for finished cosmetic products and ingredients. 
•  The requirement for a Responsible Person (RP) based in the EU to oversee the compliance 

of cosmetic products. 

•  The  need  for  a  Product  Information  File  (PIF)  for  each  cosmetic  product,  which  must 
contain information about the product's safety, efficacy, and quality, as well as the results 
of the safety assessment. 

•  The requirement for labelling and packaging compliance, including the list of ingredients, 

instructions for use, and any necessary warnings or precautions. 

From 2013 (when the CPR started to apply in its entirety) until 2025, more than 50 amendments10 
of Annexes I to VI to the Regulation have taken place to ensure consumer safety, harmonise market 
rules  and  promote  a  level  playing  field  within  the  cosmetics  sector.  In  particular, Annexes  II 
through VI of the CPR establish lists of substances that are regulated for use in cosmetic products 
within the European Union11. 

10  
11  

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02009R1223-20240424 
Annex II (prohibited substances) contains a list of substances that are strictly prohibited in cosmetic products. 
These  are  materials  identified  as  hazardous  to  human  health  and  should  not  be  used  in  any  cosmetic 
formulations. Annex  III  (restricted  substances)  includes  substances  that  are  permitted  in  cosmetics  under 
specific  conditions  or  restrictions.  It  defines  maximum  allowable  concentrations,  limitations  on  product 
types, or specific labelling requirements, etc. Annex IV (permitted colorants) lists colorants that are approved 
for use in cosmetic products, specifying the types of products in which they may be used and any associated 
restrictions  or  conditions.  Annex  V  (permitted  preservatives)  details  preservatives  that  can  be  used  in 

Page 6 of 109 

 
 
 
 
 
 
3.  Regulation (EU) 2019/1009 on EU Fertilising Products (FPR) 

The Fertilising Products Regulation was adopted by the European Parliament and the Council in 
June 2019 and entered into application in July 2022. The general objective of the measure was to 
incentivise  large  scale  fertilising  products  production  in  the  EU  from  domestic  organic  or 
secondary  raw  materials  by  creating  a  regulatory  framework  granting  such  fertilising  products 
easier access to the internal market and to address the well-recognised issue of soil contamination 
by contaminants present in fertilising products. In addition, it fundamentally changed the rules for 
plant  biostimulants,  which  were  until  then  regulated  under  the  Plant  Protection  Products 
Regulation12, by defining them based on their function rather than their ingredients. 

Following in the tradition of its predecessor, the FPR does not fully harmonise fertilising products 
on the EU market but leaves it to the manufacturer to choose if to follow the EU rules (and have 
the  free  movement  in  the  internal  market  guaranteed)  or  to  follow  national  rules  (and  rely  on 
mutual  recognition  in  case  of  sales  in  other  Member  States).  This  flexible  framework  allows 
Member States  to  maintain national  rules adapted to  their specific situation, applicable to  non-
harmonised/national fertilising products. 

The  FPR  sets  out  harmonised  rules  for  seven  categories  of  EU  fertilising  products  (fertilisers, 
liming  materials,  soil  improvers,  growing  media,  inhibitors,  plant  biostimulants  and  fertilising 
product blends). It also defines the component materials which may be used in the production of 
EU  fertilising  products,  the  labelling  requirements  and  conformity  assessment  procedures 
applicable. The FPR is based on the New Legislative Framework13 (NLF). In 2024, the FPR was 
amended to allow for voluntary digital labelling. Those rules will apply form 1 May 202714. 

The Commission is empowered to adopt delegated acts to amend Annexes I-IV to the Regulation, 
in order to adapt them to technical and scientific progress, to facilitate internal market access and 
free  movement  for  EU  fertilising  products  and  to  add  certain  additional  materials.  Since  the 
adoption  of  the  FPR  in  2019,  the  Commission  adopted  several  delegated  acts  adding  new 
component material categories or amending the existing ones, to further build the circular economy 
in the fertilising product sector15. 

cosmetics to ensure product stability and safety by preventing microbial growth. Conditions for their use, 
including concentrations and product types, are specified. Annex VI (permitted UV filters) provides a list of 
UV filters approved for use in sunscreen and other cosmetics. It specifies the allowable concentrations and 
the conditions under which these filters may be safely included in products. These annexes serve to ensure 
that cosmetic products marketed in the EU meet strict safety standards and do not pose risks to consumer 
health. 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning 
the  placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 
91/414/EEC (OJ L 309, 24.11.2009, p. 1; ELI: http://data.europa.eu/eli/reg/2009/1107/oj). 
New legislative framework - European Commission 
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). 
See current consolidated version. 

12 

13  
14  

15  

Page 7 of 109 

 
 
 
 
C.  MAIN ISSUES AT STAKE AND THE WAYS TO ADDRESS THEM 

High  product  standards  in  the  EU  are  crucial  for  the  protection  of  the  EU  citizens  and  the 
environment  and  a  fair  and  sustainable  economy.  However,  as  also  underlined  in  the  Draghi 
report16,  the  increasing  number  and  complexity  of  rules  risks  limiting  EU  businesses’  room  of 
manoeuvre, preventing them from flourishing and from remaining competitive, especially in light 
of fundamental transitions, economic instability and geopolitical tensions.  

This balancing act between ensuring the safety of products and allowing businesses to thrive is 
also a reality for the EU’s chemical sector and related sectors which are characterised by proactive 
and innovative businesses but also by a challenging regulatory and economic environment.  

Over  the  past  years,  burdens,  inefficiencies  and  obstacles  in  relation  to  the  implementation  of 
Regulations (EC) No 1272/2008, (EC) No 1223/2009 and (EU) 2019/1009 have been raised by 
stakeholders,  which  are  considered  to  cause  disproportionate  costs  or  prevent  market  access. 
Against this background, the Commission has organised Reality Checks in May 2025 to identify 
the most significant burdens and administrative obstacles under the three pieces of legislation and 
to  explore  the  potential  for  simplification  and  burden  reduction.  In  addition,  the  Commission 
received  a  significant  number  of  letters  and  detailed  analyses  from  all  types  of  stakeholders 
(companies, consumer and business associations, Non-Governmental Organisations, chambers of 
commerce, Member States’ national administrations). 

The  following  sub-sections  outline  the  main  issues  identified  and  provide  an  overview  of  the 
proposed  amendments  to  the  legal  acts  to  address  these  issues  and  to  streamline  and  ease 
compliance  with  the  three  pieces  of  EU  chemical  legislation.  These  sub-sections  also  present 
associated estimated cost savings for companies. 

1.  Issues  and  proposed  amendments  to  Regulation  (EC)  No  1272/2008  on  Classification, 

Labelling and Packaging of Hazardous Chemicals (CLP) 

The Commission received various suggestions to simplify, clarify certain provisions introduced 
into the CLP by the Regulation (EU) 2024/2865 to remove the excessive administrative burden 
stemming  from  these  provisions.  These  have  been  detailed  in  stakeholders’  proposals  for 
simplification  of  European  chemical  legislation17,  from  the  Reality  Check  on  the  possible 
simplification of chemicals legislation, that took place on 16 May 2025 and numerous position 
papers received before and after the event. The Reality Check aimed at collecting the experiences 
of stakeholders (businesses, practitioners applying EU law, consumer and business associations as 

16  

17  

of 

The 

future 

Draghi, 

European 

competitiveness, 

M. 
https://commission.europa.eu/topics/eu-competitiveness/draghi-report_en#paragraph_47059.  
For  example:  Cefic, Towards  a  simpler,  faster  and  more  supportive  legislative  framework  to  help  restore 
Europe’s competitiveness, p. 2, available at https://cefic.org/resources/cefic-views-towards-a-simpler-faster-
and-more-supportive-legislative-framework-to-help-restore-europes-competitiveness/;  VCI,  Omnibus 
proposal,  p.  4,  available  at  https://www.vci.de/ergaenzende-downloads/vci-sectorial-omnibus-chemical-
industry.pdf; Business Europe, Reducing regulatory burden to restore EU’s competitive edge, p. 12, available 
at: 
https://www.businesseurope.eu/wp-content/uploads/2025/02/2025-01-
22_businesseurope_mapping_of_regulatory_burden-d55-1.pdf.  

available 

2024, 

at: 

Page 8 of 109 

 
 
 
 
well as competent authorities) on the impact the CLP rules have on their activities, identifying any 
unintended  consequences  of  the  newly  introduced  rules,  and  exploring  possibilities  for 
simplification, cost-savings and reduction of the administrative burdens. 577 participants in total 
attended the event, and over 150 position papers with additional information were received as a 
follow-up.  Overall,  the  Commission  received  information  from  industry,  both  from  large 
companies  and  SMEs,  from  non-governmental  organisations  and  from  national  competent 
authorities. The  Commission  has  analysed  the  wealth  of  additional  data  and  compared  to  data 
received during the CLP revision between 2020 and 2023, bearing in mind the objectives of the 
CLP to ensure a high level of protection of human health and the environment on one hand and the 
free movement of substances and mixtures on the other hand. 

a.  Mandatory formatting requirements, including minimum font sizes and line spacing 
for the labelling of hazardous chemicals introduced by the Regulation 2024/2865 

Regulation (EU) 2024/2865 laid down minimum requirements for the label formatting, as follows 
in Table 1, in addition to existing rules for minimum label and pictogram sizes: 

Table 1: Minimum dimensions of labels and pictograms and minimum font size 

Capacity of the 
package 

Dimensions of the label (in 
millimetres) for the 
information required by 
Article 17 

Dimensions of each 
pictogram (in 
millimetres) 

Minimum font 
size 
(x-height in 
millimetres) 

Not  exceeding  0,5 
litres 

Greater  than  0,5 
litres 
not 
but 
exceeding 3 litres 

than  3 
Greater 
litres 
not 
but 
exceeding 50 litres 

Greater 
litres 
exceeding 
litres 

than  50 
not 
but 
500 

Greater  than  500 
litres 

If possible, at least 52×74 

Not smaller than 10×10 
If possible, at least 
16×16 

At least 74×105 

At least 23×23 

At least 105×148 

At least 32×32 

At least 148×210 

At least 46×46 

1,2 

1,4 

1,8 

2,0 

2,0 

In addition, section 1.2.1.5 in Annex I to the CLP regulation provides that: 

‘The text on the label shall have the following characteristics: 

(a) printed in black on a white background; 

Page 9 of 109 

 
 
 
 
(b) the distance between two lines shall be at least 120 % of the font size; 
(c)  a single font that is easily legible and without serifs shall be used; 
(d) the letter spacing shall be appropriate for the selected font to be easily legible. 

For the labelling of inner packaging where the contents do not exceed 10 ml, the font size may 
be smaller than indicated in Table 1.3, as long as it remains easily legible, where it is deemed 
important to place the most critical statement, such as a hazard statement or EUH statement, 
and where the outer packaging meets the requirements of Article 17.’ 

These  changes  followed  up  from  the  Fitness  Check18  which  identified  labelling  of  hazardous 
substances and mixtures as an issue. The Fitness Check noted that labels for those substances and 
mixtures were overcrowded and difficult to read. ‘Labelling space on chemical products is usually 
limited, while at the same time many pieces of legislation in addition to the CLP require different 
labelling elements’. The requirements are so extensive that ‘labels can become overloaded with 
information e.g. too much text, too long and not meaningful chemical names to non-professional 
users  making  it  difficult  for  downstream  users  and  consumers  to  focus  on  the  essential  hazard 
information, thus reducing the effectiveness of hazard communication. Too much text included on 
labels,  especially  when  this  is  required  to  appear  in  multiple  languages,  thus  restricting  the 
understandability of the information’19. Too much text is included on labels, especially when this 
is required to appear in multiple languages (in countries with more than one official language), 
thus  restricting  the  understandability  of  the  information.  The  Fitness  Check  suggested  that 
(partially) digitalised  labels could  improve the situation: ‘There are inefficiencies in  relation  to 
consumer  labelling  under  the  CLP  regulation  […]  in  terms  of  proportionality  of  costs  for 
companies to  change some aspects  of labelling  and the effectiveness  of  the communication. In 
addition, the length and amount of hazard and precautionary statements that need to be printed on 
some labels lead some consumers to become inured to the hazards that mixtures (mainly) pose, 
reducing  the  ability  of  the  hazard  communication  to  deliver  its  intended  benefits. The  existing 
provisions and requirements do not take into account opportunities offered by digitalisation which 
could help reaching consumers more effectively, increase the amount of available information e.g. 
via  printing  Q-R  codes  to  be  scanned  with  a  mobile  phone,  and  at  the  same  time  reduce  costs 
related to labelling’20.  

The CLP regulation, before its amendment by Regulation (EU) 2024/2865, required label elements 
to ‘stand out clearly from the background and they shall be of such a size and be spaced in such a 
way as to be easily read’. In its Guidance on labelling and packaging in accordance with Regulation 

18  

19  
20  

Commission Staff Working Document - Fitness check of the most relevant chemicals legislation (excluding 
REACH),  as  well  as  related  aspects  of  legislation  applied  to  downstream  industries  Accompanying  the 
document Report from the Commission to the European Parliament, the Council, the European Economic 
and Social Committee and the Committee of the Regions Findings of the Fitness Check of the most relevant 
chemicals legislation (excluding REACH) and identified challenges, gaps and weaknesses, SWD(2019) 199 
https://eur-lex.europa.eu/legal-
Fitness  Check), 
final 
content/EN/TXT/HTML/?uri=CELEX:52019SC0199. 
See Commission SWD Fitness Check p. 53. 
See Commission SWD Fitness Check p. 280. 

(Commission 

available 

SWD 

at: 

Page 10 of 109 

 
 
 
 
(EC)  No  1272/200821,  ECHA  recommends  in  section  5.2  a  minimum  font  size  of  1.2mm  (‘x-
height’) as a reference. It further states that ‘a supplier may decide whether to increase the letter 
size with the overall volume of the packaging and dimensions of the label, or […] a supplier may 
decide whether to have larger letter sizes for certain label elements while others are presented in 
smaller letters’22. ECHA’s guidance gives flexibility on the minimum font size, depending on the 
label elements, the volume of the packaging, the size of the label.  

The Impact Assessment  Report23 for the targeted revision of the CLP  Regulation  identified the 
need  to  improve  communication  of  hazard-related  information,  including  the  legibility  and 
readability of CLP labels. It noted ‘that consumers and workers are often faced with unattractive 
labels  with  too  much  text  in  too  small  font  size,  in  particular  in  relation  to  multilingual  labels 
restricts the comprehensibility of the information displayed’24. Moreover ‘the unspecific rules also 
hamper enforcement efforts as different interpretations are possible e.g. of what “size and spacing 
as to be easily read” actually means. Despite the existing guidance [which illustrates example of 
what  can  be  considered  to  be  easily  read],  the  problem  persists,  as  the  guidance  is  not  legally 
binding. Without further action, the problem will persist or even increase’25. 

The  Impact  Assessment  analysed  ‘the  possibility  to  amend  Section  1.2 Annex  I  to  introduce 
general provisions for a minimum font size and other provisions to improve the readability of the 
label, based on current ECHA guidance’26 in conjunction with additional flexibility to use fold-out 
labels. The Impact Assessment further noted that formatting requirements would come together 
with allowing a wider use of fold-out labels, noting that ‘it is likely that suppliers will only opt for 
a fold-out label where it actually is economically beneficial for them’27. However, they would also 
apply to standard labels28. 

The Impact Assessment acknowledged that ‘adjusting to a new labelling format would incur initial 
conduct  of business  cost but  the changes  are not  a stand-alone measure and  costs would occur 
anyway as a result of other changes. Potential cost could also be compensated by taking advantage 
of the wider possibilities to use fold-out labels.’ 29 In other words, the Impact Assessment assumed 
that companies voluntary moving to fold-out labels would identify savings larger than the one-off 

21  

22  

23  

24  
25  
26  
27  
28  
29  

Guidance on labelling and packaging in accordance with Regulation (EC) 1272/2008, rev. 4.2 March 2021, 
https://echa.europa.eu/documents/10162/2324906/clp_labelling_en.pdf/89628d94-573a-4024-86cc-
0b4052a74d65.  
Guidance  on  labelling  and  packaging  in  accordance  with  Regulation  (EC)  No  1272/2008,  p.  45. 
https://echa.europa.eu/documents/10162/2324906/clp_labelling_en.pdf/89628d94-573a-4024-86cc-
0b4052a74d65. 
Commission Staff Working Document Impact Assessment Report Accompanying the document Proposal for 
a Regulation of the European Parliament and of the Council amending Regulation (EC) No 1272/2008 of the 
European  Parliament  and  of  the  Council  on  classification,  labelling  and  packaging  of  substances  and 
mixtures,  SWD(2022)  435  final,  available  at:  https://environment.ec.europa.eu/publications/proposal-clp-
revision_en. 
Impact Assessment for the Revision of CLP, p. 347. 
Impact Assessment for the Revision of CLP, p. 347. 
Impact Assessment for the Revision of CLP, p. 348. 
Impact Assessment for the Revision of CLP, p. 340. See measures #12 and #15. 
Impact Assessment for the Revision of CLP, p. 348. 
Impact Assessment for the Revision of CLP, p. 348. 

Page 11 of 109 

 
 
 
 
relabelling costs. As this would be a company choice, the report did not consider those costs. The 
report further noted that ‘[such a change] is not likely that [minimum font requirements] would 
have an impact on the market size.’ Companies would not gain or loose market share because of 
their choice of label types. 

The intelligence collected and evaluated during the Impact assessment did not identify significant 
issue with setting minimum font requirements based on the recommendations of ECHA’s guidance 
and in the absence of specific requirements to analyse. One can infer from the report that most 
hazardous substances and mixtures are correctly labelled in accordance with ECHA’s guidance, 
using 1.2mm as a reference for minimum size of letters. The Impact assessment further noted that 
‘SMEs  did  not  express  a  particular  opinion  on  [minimum  typographic  requirements]  and 
concluded  that  prices  of  consumer  goods  are  unlikely  to  be  significantly  influenced  by  [these 
changes]’. 

As a whole, it concluded that the few negative impacts (e.g. fold-out labels being more expensive 
than  regular  2D  ones  and  their  design  more  difficult)  were  offset  by  recurrent  savings  from 
labelling simplification (€49 million, see Table 2), under the assumption that suppliers would make 
a voluntary choice to move to fold-out labels, where they identify economic benefits. 

Table 2: Overall costs and benefits for changes to the CLP communication of hazards  
estimated in Impact Assessment Report 202230 

Description of changes 

Non-labelling  of  fuel  and 
small items (e.g., pens) 

Flexibility for fold-out labels 

Costs  
(recurrent  or  one-off  ones) 
[target] 
€8.61 million 
(recurrent) 
[indirect for consumers] 

Benefits  
(recurrent  or  one-off  ones) 
[target] 
€9.91 million 
(recurrent) 
[direct for industry] 
€39.50 million 
(recurrent) 
[direct for industry] 

Aside  to  the  new  provisions  on  label  formatting,  Regulation  (EU)  2024/2865  introduced  other 
changes related to labelling of hazardous substances and mixtures. It is now possible to use fold-
out labels as regular label31, providing more flexibility to stakeholders to choose the type of labels. 
Existing  derogations  for  very  small  packaging  (below  10mL)  were  further  extended,  but  still 
limited  in  terms  of  eligible  hazardous  substances  or  mixtures.  Furthermore,  the  labelling 
requirements of fuels at service stations was softened. Other derogations for small packaging (less 
than 125mL) remained untouched. 

Stakeholder views 
Overview of comments received 

30  
31  

See table 98, Impact Assessment for the Revision of CLP, p. 348. 
Previously fold-out labels could be used by derogation only, in exceptional cases. 

Page 12 of 109 

 
 
 
 
 
 
A large majority of the commenting stakeholders from industry raised, during the Reality Check, 
strong  concerns  about  costs  and  administrative  burden  triggered  by  the  new  rules  of  label 
formatting laid down in Regulation  (EU) 2024/2865  as  the rules  lack flexibility. This  followed 
from  some  earlier  and  more  isolated  comments  around  the  adoption  of the  CLP  Revision.  The 
stakeholders highlighted that the future formatting requirements have long-lasting consequences 
impacting the majority of their portfolio, such as a loss of flexibility for labelling resulting in a 
forced  move  to  fold-out  labels  or  a  multiplication  of  stock-keeping  units  due  to  a  change  to 
monolingual 2D-labels, because of fewer languages fitting on a 2D label32 (see below). They called 
first for a pause in implementing the future formatting rules, followed by a revision of these rules. 
The  former  would  give  enough  certainty  and  an  early  signal  to  industry  to  also  pause  their 
investments in updating their labels, processes and production or logistic lines. Moreover, industry 
called  for  flexibility  in  ensuring  that  labels  are  readable,  considering  the  diversity  of  products, 
audience and business models.  

According to the majority of input from industry, the last column of table 1.3 in section 1.2.1.4 
and section 1.2.1.5 in Annex I to the CLP regulation should be deleted. Some stakeholders also 
referred to  the  existing  rules  laid down in  Food  Information to  Consumers (FIC) Regulation33, 
more specifically for products sold to consumers. A limited number of companies hence indicated 
that an alignment with the FIC Regulation could be possible, where the minimum font size is 1.2 
mm with a possibility to use 0.9 mm for smaller labels and packaging. There may also be a need 
to develop a holistic analysis of labels for chemicals. Some companies indicated that they would 
alternatively welcome an alignment with the Food Information to Consumers (FIC) Regulation34, 
where the font size is 1.2 mm with a possibility to use 0.9 mm for smaller labels and packaging. 
Some  other  companies  noted  that  for  trade  between  companies,  REACH  requires  the 
communication of a safety data sheet, which communicate hazard to a greater extent than a CLP 
label does, which is used by recipients as the primary source of information. They suggested to 
exempt chemicals traded to industrial or professional users from the rules provided in Regulation 
(EU) 2024/2865 and revert back to current generic CLP rules. 

Some Member States showed understanding about the reintroduction of flexibility in rules on label 
formatting without reducing the level of protection of human health and of the environment. Other 
MSs,  joined  by  NGOs,  called  for  sticking  to  the  agreed  rolling-out  of  the  provisions  of  the 
Regulation (EU) 2024/2865 as industry still has time to adjust and the current requirements would 
still be the best option to ensure legible labels. 

32  

33  

Some companies even flagged that fewer languages would fit on the type of fold-out labels they currently 
use, leading as well to an increase number of SKUs. 
Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the 
provision  of  food  information  to  consumers,  amending  Regulations  (EC)  No  1924/2006  and  (EC)  No 
1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, 
Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European 
Parliament  and  of  the  Council,  Commission  Directives  2002/67/EC  and  2008/5/EC  and  Commission 
Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, p. 18, ELI: http://data.europa.eu/eli/reg/2011/1169/oj). 

Page 13 of 109 

 
 
 
 
 
Detailed description of evidence received 

As a starting point, stakeholders from industry, including SMEs, commented that they have more 
labels than initially identified (up to 1000 or more, some already multilingual ones for paint or 
detergent SME manufacturers compared to between 200 and 300 monolingual labels for detergent 
SMEs and between 2250 and 3750 ones for large companies in the CLP IA35). Those labels may 
already contain multiple languages in order to place products in multi-lingual countries such as 
Belgium or Finland, which request more than one language on CLP labels, but also because of 
cost-saving synergies in the single market and outside the EU/EEA (up to 31 languages per label 
for  some  large  lubricant  companies).  Multilingual  labels  for  combinations  of  national  markets 
currently  minimises  the  need  of  stock-keeping  units  (SKU),  streamlining  label  design  and 
production,  labelling,  logistic,  market  supply  across  MS  and  limiting  waste  (see  table  below). 
Industry  highlighted  that  the  choice  of  grouping  or  not  languages  on  labels  should  belong  to 
companies, depending on their business model as long as it stays within the framework provided 
by the CLP regulation and other pieces of legislation.  

Companies that described their on-going processes or strategies to align with the future labelling 
rules confirmed that they no longer find any flexibility left with the requirements for minimum 
font  size,  minimum  line-spacing  and  black  font  on  white  background.  Most  of  the  repliers 
indicated that they are forced to move fold-out labels and that the large majority of their labels36 
need to be redesigned (between 13% to 100%, with an estimated average between 80 and 95%), 
as identified by the CLP IA. However, they stressed that the number of languages fitting on a label 
will be negatively impacted, forcing them to move to fold-out labels, or to reduce the number of 
languages  per  label  and  increasing  the  number  of  SKUs.  In  some  extreme  cases,  companies 
highlighted technical difficulties to extend their current fold-out labels to allow enough space as 
required  by  Regulation  (EU)  2024/20865  (i.e.  with  7  to  11  pages)  to  keep  their  SKU  number 
unchanged. Initially, it was estimated that ‘the use of a fold-out label versus a standard label would 
be a voluntary business choice of the relevant supplier. It is likely that suppliers will only opt for 
a fold-out label where it actually is economically beneficial for them’37. According to new evidence 
received, it turns out that in most cases industry will be forced to use fold-out labels. ‘The use of 
a  fold-out  label  versus  a  standard  label  would  be  a  voluntary  business  choice  of  the  relevant 
supplier. 

The input from industry also highlighted that contrary to the initial assessment, such decisions on 
labelling strategies are strongly connected to other increased costs (e.g., relating to logistics, in-
house/outsourcing of labels, storage capacities, SKU, labelling robots/printers and price difference 
between labels) and  finally  to the business model  of companies.  In addition, some of the costs 
incurred would be recurrent. A qualitative summary of the evidence is provided in Table 3.

35  

36  

37  

CLP IA, table 98 p.  342. Savings were identified for the detergent industry, considering a range of 40-60 
products and up to 5 languages per SME and 150-250 products and up to 15 languages for large companies. 
Many companies reported that 100% of their labels have to be redesigned. Some national sector organisations 
reported 95% of the labels would undergo the redesign process. The lowest rate reported  was 13% for an 
SME manufacturing lubricants, which seems to be a singleton. 
Impact Assessment for the Revision of CLP, p. 340. 

Page 14 of 109 

 
 
 
 
Table 3: Overview of impacts and their qualitive assessments (+: positive, -: negative, o: neutral) 

Consumers 

Initial Assessment 
Increased legibility/readability (+) 

Increased legibility/readability (+) 
Prominence of CLP label elements, instead of instructions for use (-) 

Reality Check 

Prominence 
of CLP 
label 
elements, 
instead of 
instructions 
for use (-) 

Industry 

Fold-out labels as regular labels; 
More languages on fold-out  labels, 
simplifying the supply of the single 
market (+); 
Redesigning labels (-); 
Relabelling product (-); 
(Increased costs of fold-out labels38) 
Impact on market size (o) and price 
of consumer goods (o) 
Impact  on 
generated waste (o-) 
Impact  on  the  single  market  and 
competition (+) 

raw  materials  and 

Increased  space  for  CLP  labelling  at  the  expense  of  other  compulsory  label  elements, 
marketing  elements  (-);  In  some  cases,  increased  packaging  size  in  contradiction  to  the 
Packaging  and  Packaging  Waste  Regulation39  (PPWR)  (-);  Increased  material  for 
communication (leaflet for other label elements than CLP ones) (-); 
Fold-out labels as most frequent labels (-). Same number of languages on fold-out labels but 
increased number of pages and technical practicalities (-); 
Alternatively single-language labels (-); 
Redesigning labels (-); 
Relabelling product (-); 
Fold-out labels are thicker, impacting packaging size and labelling/production lines (-); 
Fold-out labels are not applied as 2D labels: new equipment, additional production/labelling 
lines where fold-out and 2D labels, additional space (-); 
Increased  number  of  pre-printed  labels  or  packaging  negatively  impact  production  time 
(setting lines between two labels) (-); 
Increasing the number of SKU (-) or reduction of market size where SKUs no longer break 
even (-); 
Increased needed space for stock (-); 
Increased complexity for logistics (-); 

38  

39  

The higher cost of fold-out labels compared to 2D labels is acknowledged in  Impact Assessment for the Revision of CLP. However, it is not factored into the 
recurring costs. 
Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 
2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (OJ L, 2025/40, 22.1.2025, ELI: http://data.europa.eu/eli/reg/2025/40/oj). 

Page 15 of 109 

 
 
 
 
 
Environment  Neutral 

impact  (o)  apart  from 
redesigning current labels and some 
moves to fold-out labels 

Outsourcing  fold-out  labels:  additional  label  stocks  (minimum  order  for  labels),  potential 
increase waste for out-dated labels (-); 
Packaging with fold-out labels are more difficult to recycle (costs where extended producer 
responsibilities are in place). Possible impact on eco-design; 
For  business-to-business  trade,  an  SDS  is  required,  providing  more  granular  hazard 
communication than CLP labels. 
Lower  level  of  recyclability  (-),  including  additional  fees  in  MS  when  extended  producer 
responsibility schemes are in place (-); 
Additional copies of labels needed and possibly discarded when labels are updated (when label 
printing is outsourced) (-); 
Additional (immobilised) materials and products where additional SKUs are needed (-); 
More complex logistic management (o). 

Page 16 of 109 

 
 
 
 
 
Regarding  simple  2D  labels,  both  SMEs  and  larger  companies  reported  that  almost  all  labels 
should be redesigned to comply with the new rules, especially with the minimum font sizes and 
line spacing. According to evidence submitted by a large company, the decrease in space on the 
label left to other elements than CLP ones would reach up to 60% for products larger than 1L. This 
decrease would leave almost no space on the label for other label elements than CLP ones on the 
back of a product, if all other parameters remain unchanged (e.g., the number of languages). Some 
companies mentioned that they would need to label the front and the back of the product to comply 
to the future CLP requirements, notwithstanding the additional labelling requirements from other 
pieces of legislation, such as the Detergents regulation40 or the PPWR. 

Following new formatting requirements, the number of languages per label would be reduced by 
a  factor  of  2  or  3,  according  to  some  stakeholders,  both  SMEs  and  larger  companies.  Many 
companies  highlighted  the  extreme  but  possibly  frequent  case  of  2D  labels  where  only  one 
language would fit. As a first consequence, companies are forced to consider switching from 2D 
labels to fold-out labels in the 3 Member States which request more than one official language on 
the label41. In this case, the number of different labels would not increase but a forced move to 
fold-out  label  bears  both  one-off  (setting  a  labelling  line  and  redesigning  labels)  and  recurrent 
costs42 (higher costs of labels, higher redesign costs and outsourcing labels) - see below section 
estimated savings for subsequent consequences. As an alternative consequence, companies could 
also  be  forced  to  develop  single-language  2D  labels  in  order  to  avoid  fold-out  labels,  thus 
undermining  the  single  market  for  chemical  products.  In  both  cases,  this  would  increase  the 
number of labels or printed packaging, of stock-keeping units (SKU) and logistics space needed, 
as  well  as  the  cost  of  any  future  label  changes  due  to  multiplication  of  labels.  Companies 
mentioned an increase of SKUs, which requires more storage capacities and logistic operations on 
a recurrent basis. Some companies mentioned up to €40 million investment required for storage 
and logistic capacities. Because of those additional costs, some companies even state that they no 
longer have a business case for their products in the market of smaller Member States, if they need 
to label them with monolinguistic labels. According to those companies, an increased number of 
SKUs indeed implies reduced turn-over per SKUs, to the point that some SKUs make not break 
even  and  would  be  terminated.  Companies  would  stop  placing  those  products  in  these  smaller 
markets, disrupting the single market and challenging a fair competition in those markets.  

The Impact Assessment Report accompanying the proposal for an amending regulation concluded 
that fold-out labels represent an alternative solution to 2D labels, offering enough space for all 
label elements, including those requested by the CLP. As discussed above, such changes should be 

40  

41  

42  

Regulation (EC) No 648/2004 of the European Parliament and of the Council of 31 March 2004 on detergents 
(OJ L 104, 8.4.2004, p. 1, ELI: http://data.europa.eu/eli/reg/2004/648/oj). 
See Guidance document on labelling and packaging in accordance with Regulation (EC) No 1272/2008, rev. 
4.2,  footnote  7,  p.  15  and  Document  ‘Languages  required  for  labels  and  safety  data  sheets’, 
https://echa.europa.eu/documents/10162/17217/languages_required_for_labels_and_sds_en.pdf/735e95d2-
1b84-4f6a-a196-fb65a756300f.  
The concerned companies still have the flexibility to switch all their labels to fold-out ones or only those for 
which available space is no longer sufficient. In the former case, they would probably have to out-source all 
label production, whereas in the latter, they would have to set up a different labelling line for fold-out labels 
or improve their existing one to accept both roll labels and stack ones. 

Page 17 of 109 

 
 
 
 
decided by companies, where there are economic benefits. According to industry, as also reported 
above,  the  formatting  requirements  remove  the  flexibility  foreseen  in  the  CLP  IA.  Industry 
informed that fold-out labels are up to 4 times more expensive than 2D labels (printed in-house) 
(according to concurring sources for a recurring cost). Moreover, labelling lines for (stack) fold-
out labels are not compatible with labelling machines fed by rolls of (pre-printed) labels, triggering 
one-off investment costs. The production of fold-out labels is outsourced, increasing the SKUs, as 
well as the length of the supply chain and the cost of future label changes. To these recurrent costs, 
industry also identify one-off costs in switching their 2D-labelling lines to printers and labelling 
machines for fold-out labels. Some SMEs reported investments of between €0.5 million and €1.5 
million to adapt their production line to printers/labelling machines handling fold-out labels. 

Some companies which already use fold-out labels also shared concerns about the impact of the 
new  rules  on  font  sizes  and  label  formatting. They  indicated  that  keeping  the  same  number  of 
languages would be a technical challenge as the fold-out label would expand from 3 or 4 pages to 
up to 11 pages.  

Regarding  environmental  impact,  the  Impact  Assessment  Report  did  not  identify  positive  or 
negative  impacts.  However,  industry  highlights  that  possible  negative  effects  are  reported  as  a 
consequence of increased SKUs, such as more space needed, more products stored (and not yet in 
the supply chain), resulting in more CO2 emitted and more raw material used. For future changes 
of labels, this could also  create more waste, as fold-out  labels  and packaging  bearing them  are 
more difficult to recycle than for 2D ones. Moreover, industry stated that, where fold-out labels 
are  not  an  option,  the  ultimate  option  of  increasing  the  size  of  the  packaging  to  fit  all  require 
elements  in  sufficient  space  would  be  incompatible  with  the  limitation  of  packaging  size  (and 
packaging waste) requested by the Packaging and Packaging Waste Regulation and in the end to 
the environment. 

Regarding social impacts, the changes could increase the need of workers in the labelling industry 
or in the chemical industry (according to some companies, updating 5 000 labels is equal to 1 full-
time equivalent for a year). This would lead to the increase of costs of chemical products, including 
of many consumer products, as most companies stated that the extra costs will be transferred to 
the price of their products. 

Regarding protection of human health and of the environment for consumers and other users of 
chemicals, non-governmental organisations shared their concerns about a possible amendment of 
the  rules  on  CLP  label  formatting,  which  would  jeopardise  the  increased  protection  of  human 
health  and  of  the  environment  offered  by  Regulation  (EU)  2024/2865.  They  recalled  that  the 
Fitness  Check  concluded  that  consumers  are  not  well  informed  because  labels  of  chemicals 
products  are  overcrowded  and  too  obscure,  making  them  difficult  to  understand  and  read  by 
consumers. They referred to the positive outcome identified in the impact assessment for the CLP 
revision,  where  costs  stemming  from  formatting  rules  for  labels  are  counterbalanced  by  more 
flexibility on the types of allowed labels. 

The Member State feedback reflects overall a broad consensus on the importance of ensuring label 
readability  to  protect  health  and  environmental  safety.  Furthermore,  some  Member  States  raise 

Page 18 of 109 

 
 
 
significant concern about the proportionality of the possible simplification measures suggested by 
industry, their feasibility including the timing of a legislative proposal. Such changes would come 
just after the adoption of Regulation (EU) 2024/2865, before its full application. This could create 
uncertainties and potential additional administrative costs for both national authorities and industry 
players.  

Several  Member  States  insisted  that  the  minimum  font  size  of  1.2  mm  x-height  should  not  be 
lowered,  as  this  would  compromise  label  legibility.  They,  however,  showed  openness  to  the 
alignment  of  the  font  size  rules  to  those  laid  down  in  Food  Information  to  Consumers  (FIC) 
Regulation, where the font size is 1.2 mm with a possibility to use 0.9 mm for smaller packaging. 
Such  alignment  is  viewed  to  reduce  manufacturing  complexity  and  promote  cross-sector 
efficiency.  

One  Member  State  suggested  focusing  on  more  prominent  formatting  for  consumer  products, 
while potentially exempting professional and industrial products – considering that professional 
and industrial users are protected by Occupational Safety and Health legislation and have access 
to hazard information via the safety data sheets. 

A  number  of  Member  States  advocated  for  embracing  digital  labelling  to  alleviate  label  space 
constraints and improve legibility. They suggest expanding the scope of information to be provided 
on a digital label beyond what is currently allowed under the CLP Regulation. However, concerns 
are also raised by other Member States about digital divide issues and the practicality of accessing 
digital information during emergencies.  

Regarding impacts on human health and of the environment, the Fitness Check noted that labels 
not only difficult to read but also overcrowded and difficult to read. The CLP Regulation requires 
labelling of hazardous substances and mixtures to inform about their hazard properties. Via the 
precautionary  statements  selected  according  to  the  hazardous  properties,  the  CLP  part  of  label 
informs about good handling in a generic way. According to the Eurobarometer, consumers note a 
chemical is hazardous thanks to the presence of pictograms and in turn read the use instructions to 
understand how to safely use such a product. There should be sufficient space left for other pieces 
of  information  which  are  critical  to  use  and  dispose  of  a  chemical  product  in  a  safe  way,  like 
detailed  dosage,  use  instructions  or  sorting  instructions  for  disposal.  Space  dedicated  to  those 
pieces of information should enable an easy reading. 

Moreover,  consumers  may  not  always  understand  long  and  complex  chemical  names  when 
provided  as  required  by  the  CLP  Regulation,  ‘making  it  difficult  for  downstream  users  and 
consumers to focus on the essential hazard information, thus reducing the effectiveness of hazard 
communication. Too much text included on labels, especially when this is required to appear in 
multiple languages, thus restricting the understandability of the information’43. Regulation (EU) 
2024/2865  only  look  at  one component of the problem identified in  the  Fitness  Check and the 
solutions it offers may not flexibility to fix the other components to make labels of chemicals easy 
to understand to consumers and other users of chemicals. Regulation (EU) 2024/2865 does not 

43  

See Commission SWD Fitness Check p. 53. 

Page 19 of 109 

 
 
 
 
differentiate between consumers and professional or industrial users, where the latter would have 
a better understanding of labels or other ways to access information on hazards and on how to 
safely use hazardous chemicals. 

Proposed amendments and next steps  
The Commission takes note that the future rules laid down in Regulation (EU) 2024/2865 leave 
no flexibility for businesses. The future situation would possibly create large negative impacts on 
the  chemical  industry,  such  as  increased  costs,  a  more  fragmented  single  market  for  chemicals 
leading to a reduced competitiveness of the European chemical industry. The Commission suggests 
bringing back sufficient flexibility in label formatting requirements. This would allow companies, 
depending on their business model and the types of products in their portfolio, to make the most 
responsible  decision  on  appropriate  and  informative  enough  CLP  labels  for  their  customer 
responsibly. 

The Commission proposes to replace specific mandatory label formatting rules introduced by the 
Regulation  (EU)  2024/2865  to  set  up  generic  obligations.  The  proposed  amendments  would 
require labels to stand out clearly from the background and to be of such a size and be spaced in 
such a way as to be easily read, thus focusing on keeping labels clear and readable rather than 
enforcing rigid formatting rules. The proposed amendments are guided by the key objectives of 
administrative  burden 
simplification  and  enhancing  European 
competitiveness,  as  well  as  ensuring  cost-effective  delivery  of  the  policy  objectives  of  the 
European Green Deal. 

regulatory 

reduction, 

Provisions  in Article  31  would  have  to  be  complemented  by  more  detailed  guidance  than  the 
current guidelines. Such guidelines would be developed by ECHA, in order to provide more clarity 
to this issue. They could be inspired by what is available for Food Information to Consumers and 
on consumer behaviour.  

The  proposed  amendments  and  complementing  guidance  are  guided  by  the  key  objectives  of 
simplification  and  enhancing  European 
administrative  burden 
competitiveness,  as  well  as  ensuring  cost-effective  delivery  of  the  policy  objectives  of  the 
European  Green  Deal,  while  keep  a  high  level  of  protection  of  human  health  and  of  the 
environment. 

regulatory 

reduction, 

Estimated cost savings 
Based  on  the  input  from  stakeholders  ahead  and  during  the  Reality  Check,  the  savings  of  the 
proposed amendments are estimated.  

Possible savings estimated for the detergent industry 

For  the  detergent  industry,  the  Impact  Assessment  Report  accompanying  the  proposal  for  an 
amending  regulation  concluded44  that  a  broader  use  of  fold-out  labels  would  generate  annual 

44  

Stakeholders from the industry did not negatively comment on measure #12 in conjunction to measure #15 
during the development of the Impact Assessment for the Revision of CLP. However, concerns were received 
once the adopted Commission Proposal became available. 

Page 20 of 109 

 
 
 
 
savings  of  between  €24  million  and  €55  million  (see  table  98  in  that  report).  From  the  initial 
assessment45, savings from a voluntary use of fold-out labels instead of monolingual 2D ones were 
estimated  as  between  €618 750  and  €1 406 250  per  large  detergent  companies  and  between 
€55 000 and €112 500 for SMEs manufacturing detergents, considering an average of 15 labels 
per products for a large company and 5 for an SME.  

The  semi-quantitative  data  received  since  the  publication  of  the  Impact  Assessment  for  the 
Revision of CLP highlights the following shortcomings46: 

•  Significant recurring increased cost per label, from moving from in-house printing or pre-
printed  labels  to  fold-out  labels  or  for  designing  fold-out  labels  with  fewer  languages: 
between 22% and 200%; 

•  Significant one-off investment costs to set up a labelling line  and associated storage for 
fold-out labels, which are usually stack labels, compared to 2D labels, which come in rolls: 
the  cost  of  new  printers  or  labelling  machine:  €4 000  to  €40 000  per  label  printing 
equipment  and  €170 000  to  €250 000  per  labelling  robots  (one  for  each  impacted 
production line and between 2 and 4 production lines per site); 
Indirect recurrent costs of a longer supply chain, because of outsourced production of (fold-
out) labels or few languages per label and more labels, resulting in an increase of SKUs: 
between 22% to 400% (for 3 000 products, from 15 000 SKU to 40 000 SKU in a large 
company); 

• 

•  Future  more  complex  amendments  of  labels  because  of  classification  update:  increased 
time and resource for designing more labels and/or fold-out ones, as well as destruction of 
unused fold-out labels;  

From these new pieces of evidence, it seems that current 2D labels may often bear more than one-
language,  some  companies  already  use  multi-language  fold-out  labels  and  the  price  difference 
between 2D labels and fold-out ones is not considered in the relabelling cost in the IA, as fold-out 
labels were expected to be voluntary. Furthermore, the initial assessment did not identify an impact 
on the price of chemical products, at least for SME companies. 

Three theoretical scenarios are analysed in greater details in the Annex II: (i) companies using a 
mix of 2D labels and fold-out ones, which can keep their labels but face more complex and slightly 
more expensive labelling costs (see Table 4), (ii) companies using 2D labels which have to develop 
monolingual labels for all their products47 (see Table 5) and (iii) companies using 2D multilingual 
moving  to  fold-out  labels  containing  the  same  amount  of  information  because  of  the  future 
formatting rules  (see Table 6). The real  situation may be more  complex,  with  some companies 
using a mix of 2D and fold-out labels, some labels being already compliant with new rules. 

45  
46  
47  

Impact Assessment for the Revision of CLP, p. 342 
See Table 3 for a comprehensive qualitative overview of reported impacts. 
This estimate does not cover the case highlighted by some stakeholders that they would have to develop a 
new packaging (addition of an additional secondary packaging or larger primary packaging). 

Page 21 of 109 

 
 
 
 
Table 4: Possible costs for detergent manufacturers with a mix of 2D and fold-out labels  
(unchanged number of labels and slightly increased price per label, in addition 
 to 100% relabelling to comply with Regulation (EU) 2024/2865). 

Average number of labels 

Average relabelling costs from Reg. (EU) 2024/2865 

Current 

Future 

One-off costs 

Recurrent costs 

Total annualised costs 

7 
3 

7 
3 

€50 100 000 
€64 700 000 
€114 800 000 

€300 000 
€200 000 
€500 000 

€6 200 000 
€7 700 000 
€14 000 000 

Table 5: Possible costs for detergent manufacturers going only for monolingual labels 
(increased number of labels and of SKUs and unchanged price per label, 
in addition to 100% relabelling to comply with Regulation (EU) 2024/2865). 

Average number of labels 

Average relabelling costs from Reg. (EU) 2024/2865 

Current 

Future 

One-off costs 

Recurrent costs 

Total annualised costs 

7 
3 

15 
5 

€65 300 000 
€66 800 000 
€132 000 000 

€300 000 
€200 000 
€500 000 

€8 000 000 
€8 000 000 
€15 500 000 

Size  of 
company 

Large 
SME 
Total 

Size  of 
company 

Large 
SME 
Total 

Table 6: Possible costs for detergent manufacturers going only for fold-out labels (unchanged number of labels and increased 
price per label, in addition to 100% relabelling to comply with Regulation (EU) 2024/2865). 

Size  of 
company 

Large 
SME 
Total 

Average number of labels 

Average relabelling costs from Reg. (EU) 2024/2865 

Current 

Future 

One-off costs 

Recurrent costs 

Total annualised costs 

7 
3 

7 
1 

€58 500 000 
€6 300 000 
€64 800 000 

€5 000 000 
€2 400 000 
€7 400 000 

€11 800 000 
€3 200 000 
€15 000 000 

Possible savings estimated for the lubricant industry 

The lubricant manufacturers reported an already existent extensive use of fold-out labels for small 
packaging,  with  up  to  31  languages  per  label  covering  both  EU  and  non-EU  markets48.  In  the 
sector, products sold to industry or professionals represent the majority of the market, with up to 
90%  for  some  large  companies.  The  new  formatting  rules  would  force  those  manufacturers  to 
increase the number of pages of current fold-out labels, from 5 pages to 11, making it a technical 
challenge.  Alternatively,  companies  could  cluster,  with  more  fold-out  labels  covering  fewer 
Member States or countries. For larger packaging, companies need to switch to fold-out labels, 
which can be a technical challenge for products travelling by sea or stored outdoor.  

48  

For the purpose of this analysis, only EU MS markets will be considered. It should however be acknowledged 
some companies may save costs from further rationalisation of labels beyond the European languages . 

Page 22 of 109 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
Few  large  companies,  representing  about  50  %  of  the  European  market  for  lubricant,  reported 
during the Reality Check one-off relabelling cost of between €2 000 000 and €6 900 000 to comply 
with Regulation (EU) 2024/2865. Based on the market value of the sector, impacts for the whole 
sector is estimated to about €53 600 000 (one-off costs). Moreover, those companies also reported 
a recurrent  cost of future  increased number of SKUs  between €7 000 000 and  €80 000 000 per 
year per large company and around €3 000 000 for an SME. For the sector, these recurrent costs 
could amount, by similar extrapolation as for one-off costs, to €111 000 000 per year, let alone 
routine relabelling costs. Finally the impact for the lubricant sector could be estimated to about 
€119 000 000 in a conservative way. 

Possible savings estimated for the paint and ink industry 

Finally,  paint  and  ink  manufacturers  reported  higher  number  of  articles  than  in  other  chemical 
sectors,  usually  in  smaller  packaging  and  sometimes  tailor-made.  Companies  also  reported 
additional  costs  for  fold-out  labels  compared  to  2D  labels  (between  €0.15  to  €1.50  per  label). 
Similarly to detergents where 2D labels are all redesigned into fold-out ones (similarly to the 3rd 
scenario  for  detergents),  one-off  relabelling  costs  could  be  estimated  between  €3 150 000  and 
4 500 000 per large company, considering an average number of 3 000 different (fold-out) labels 
and 1 000 000 products labelled per year. The price increase for fold-out labels will increase the 
recurrent cost of routine updates of CLP labels which however could not be estimated, due to the 
limited  amount  of  evidence  available  and  the  increased  diversity  of  products  in  this  sector. 
Moreover,  companies  would  need  to  invest  in  new  labelling  machines  for  fold-out  labels,  the 
reported price of which is between €200 000 and €500 000 per production line, depending on the 
company. However, due to limited evidence from this sector, a more detailed and comprehensive 
analysis of the impacts to the paint and ink sector is not possible. 

Extrapolation to the European chemical industry 

In  order  to  further  estimate  the  overall  costs  of  the  future  rules  laid  down  in  Regulation  (EU) 
2024/2865  for  the  European  chemical  sectors,  estimated  or  reported  sectorial/national  impacts 
were extrapolated to the whole EU chemical industry (see Table 7 and calculation explanation in 
Annex II). 

Table 7: Possible costs for the EU chemical industry to comply with Regulation (EU) 2024/2865. 

Source 

Detergent sector 
(calculated) 
Lubricant companies 
(calculated) 
National paint and ink 
sector (reported) 

Member State (reported) 

Share of EU 
chemicals 
production 
value 

4.20% 

1.16% 

0.09% 

1.32% 

Annual cost 
(€ million) 

One-off cost 
(€ million) 

Extrapolation to 
EU chemicals 
industry 
(€ million) 

Type of costs  

14.0  

119.0  

60.0  

50.0  

333.0 

9 956.0 

4 481.0 

255.0 

Annual overall 
cost 
Annual overall 
cost 
Annualised 
one-off cost 
Annualised 
one-off cost 

Page 23 of 109 

 
 
 
 
 
 
 
National chemicals 
sector (reported) 

Conclusion 

11.22% 

583.0  

349.0 

Annualised 
one-off cost 

The  proposed  reversal  of  CLP  requirements  to  CLP  provisions  before  their  amendment  by 
Regulation (EU) 2024/2865 will save industry from costly adaption to the recent revision of CLP. 
Those costs have not yet fully materialised, as only some front-runners may have initiated some 
changes, the cost of which may not be fully recovered. However, the estimates, even if theoretical 
and  subject  to  many  uncertainties,  should  be  considered  as  savings,  as  they  will  materialise  if 
Regulation (EU) 2024/2865 fully applies. 

The estimates derived for the detergent industry are identified as the most robust ones amongst 
those reported in Table 7 above. Notably, they have partially based on cross-checked figures from 
existing Impact Assessments. These estimates are of the same order of magnitude as other reported 
costs when extrapolated to the whole EU chemical sector. As the Impact Assessment for the CLP 
Revision  developed  a  specific  focus  on  the  implications  of  some  measures  on  that  sector,  a 
comparison is also easier. For these reasons, the yearly savings estimated to about €333 million 
based on the extrapolation from the impact to the detergent industry will be used for the semi-
quantitative assessment of the proposed rules on label formatting. 

As the new rules from Regulation (EU) 2024/2865 would be reverted to the current situation where 
they do not apply yet, any impact on human health, on the environment or on the European society, 
whether  positive  or  negative,  would  be  also  lifted.  As  suggested  above,  clearer  guidance  on 
labelling and especially what is considered legible and readable will secure some improvement for 
the protection of human health and of the environment compared to the current situation where 
Regulation (EU) 2024/2865 does not apply yet. The reinstated flexibility for suppliers of hazardous 
chemicals to design their CLP labels in a way that is easy to read will also be useful to leave enough 
space and prominence to other parts of the label, such as the use instructions, where needed and 
required by other legislation, to inform users on how to safely use a chemical product. 

b.  Rules on advertisements 

Article 48 of CLP regulation as currently applicable49 requires the advertisements for a hazardous 
substance to mention the hazard class concerned. For mixtures, Article 48 lays down obligations 
to mention the type of hazards only for the advertisements that allow a member of the general 
public to conclude a contract for purchase without first having sight of the label. This was to protect 
the recipients of hazardous mixtures, including consumers, who would not be able to see the label 
information before the purchase.  

49  

New provisions on advertisements introduced by Regulation (EU) 2024/2865 will enter into application as 
of 1 July 2026. 

Page 24 of 109 

 
 
 
 
 
 
 
Regulation  (EU)  2024/2865  introduced Article  48a  requiring  all  distance  offers  to  indicate  full 
CLP labelling information, thus ensuring that the final user is always informed about the hazards 
concerned and is always able to see (or be informed about) all label elements, including hazard 
pictograms,  signal  words, hazard and precautionary statements before buying  a product. At the 
same  time,  Regulation  (EU)  2024/2865  amended  Article  48  and  introduced  rules  on 
advertisements that require any advertisement (including on radio, on social media, in promotional 
leaflets etc.) to indicate all hazard information, i.e. hazard pictogram, hazard statement and EUH 
statement, together with invitation to always follow the label information.  

The  introduction  of  extended  rules  on  advertisement  follows  the  identification  in  the  initial 
assessment  that  ‘non-compliance  with  the  provisions  of  CLP  on  online  advertisement  is  very 
frequent, especially for chemicals sold online, both by EU and non-EU actors. […] As online offers 
and  advertisements  often  do  not  display  hazardous  information,  consumers  may  not  be  able  to 
make  informed  choices,  or  correctly  use,  store  or  dispose  of  mislabelled  chemicals  such  as 
detergents  or  paints,  leading  to  risks  for  their  health  and/or  the  environment’50.  The  initial 
assessment looked at options to ‘[ensure] that CLP labelling is shown in online offers and online 
advertising’51  and  fix  the  ‘[ambiguities]  in  the  CLP  Regulation  about  online  offers,  online 
advertisements,  the  obligation  to  display  labelling  information  in  online  offers  and  to  mention 
certain hazard information’52. 

While measure #17 of the initial Impact Assessment looked at ‘Amend CLP provisions to make 
them explicitly apply to online offerings and online advertising and to clarify that labels need to 
be provided also for online sales’, Regulation (EU) 2024/2865 laid down extended rules targeting 
any kind of advertisement, including offline ones that constitute promotional messages without 
direct invitation to buy a product. 

Stakeholder views 
These introduced rules were highlighted by stakeholders as disproportionate and going far beyond 
what  is  required  of  other  industries,  such  as  for  pharmaceuticals,  biocidal  and  plant  protection 
products. A large majority of the stakeholders from industry which provided input raised strong 
concerns  on  the  proportionality  and  the  excessive  cost  of  the  extended  requirements  in  new 
Article 48 for promotional communications. They reminded that advertisements do not constitute 
purchase offers and do not necessarily lead to a purchase. They also emphasised that new rules 
would expand the application of Article 48 to all advertisements, including supermarket leaflets, 
TV and radio commercials and social media advertisements, including advertisements as short as 
3 seconds – while most of them were not covered by the previous requirements. 

It was pointed out that a primary way of informing users of hazardous chemicals about associated 
hazards  is  (and  should  remain  such)  the  CLP  label  on  the  product  –  which  consumers  and 
professional  users  are  always  able  to  consult  without  buying  a  product,  –  and  not  the 

50  
51  
52  

Impact Assessment for the Revision of CLP, p. 14. 
Impact Assessment for the Revision of CLP, p. 21. 
Impact Assessment for the Revision of CLP, p. 17. 

Page 25 of 109 

 
 
 
 
advertisements. As Regulation  (EU) 2024/2865  introduced  requirements  for distance sales, full 
labelling information will be always presented to a user in the online offer. 

A recurring concern  highlighted by stakeholders is  the impracticality  of  implementing the new 
requirements across all advertisement formats. Many stakeholders pointed out that certain media 
formats – particularly radio, short-form digital content, and printed materials – are incompatible 
with the volume of information required by the new Article 48. In the case of audio-only formats 
like  radio,  it  is  nearly  impossible  to  convey  complex  hazard  information  in  the  time  available. 
Similarly, social media advertisements, often designed for small screens and quick engagement, 
lack  the  necessary  space  for  full  hazard  details.  Furthermore,  for  online  sales  the  provision  on 
advertisements is in most cases redundant, as the advertisement is taking place in the environment 
of the sales offer and the consumer has direct access to the necessary hazard information through 
the product offer page, which is a click away. Printed formats, such as leaflets and promotional 
catalogues, widely used in retail sectors, not only face space constraints but also run the risk of 
becoming outdated, potentially leading to discrepancies between advertising and product labelling.  

Another  prominent  concern  is  that  the  comprehensive  inclusion  of  CLP  hazard  information  in 
advertisements  could  overwhelm  and  confuse  consumers.  Too  much  emphasis  at  the  stage  of 
advertisements would deter consumers. Several stakeholders argued that too much technical data 
can lead to disengagement, thereby reducing rather than enhancing consumer safety. A commonly 
proposed  alternative  favoured  by  majority  of  stakeholders  is  to  include  a  simplified,  uniform 
phrase such as “Always read the label and product information before use”. This approach would 
mirror practices in other EU legislation and is seen as more effective in directing consumers to the 
label where complete information is available. 

Stakeholders  from  industry  also  drew  attention  to  inconsistencies  between  new  provisions  of 
Article 48 and requirements for advertisements laid down in other sectoral legislation, such as in 
the Biocidal Products Regulation53 and the Directive on Medicinal Products54. These legislative 
acts  require  a  simple  invitation  to  consult  the  label,  rather  than  reproducing  detailed  hazard 
elements in advertisements. Stakeholders suggested harmonising requirements across regulatory 
frameworks, which is a common recommendation, to avoid confusion and redundant obligations. 

According to the input received from companies, the implementation of the revised Article 48 is 
expected  to  introduce  substantial  administrative  complexity  and  cost.  Businesses  will  need  to 
revise  existing  contracts,  marketing  materials,  and  workflows  to  ensure  compliance  with  new 
requirements. In addition to resource demands, stakeholders also highlighted the need to produce 
EU-specific  versions  of  global  advertising  content,  increasing  fragmentation.  The  challenge  is 

53  

54  

Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning 
the  making  available  on  the  market  and  use  of  biocidal  products  (OJ  L  167,  27.6.2012,  p.  1, 
ELI: http://data.europa.eu/eli/reg/2012/528/oj). 
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community 
code 
(OJ  L  311,  28.11.2001,  p.  67, 
ELI: http://data.europa.eu/eli/dir/2001/83/oj). 

to  medicinal  products 

for  human  use 

relating 

Page 26 of 109 

 
 
 
 
particularly acute for B2B communications, where audiences already rely on Safety Data Sheets 
(SDS) and are not expected to benefit from advertising-based hazard disclosures. 

Concerns  were  also  raised  about  the  potential  chilling  effect  of Article  48  on  innovation  and 
sustainability. The detergents and home care sector emphasised they can report well-established 
safe  use  records  and  low  incident  rates,  all  of  which  do  not  suggest  that  intensified  hazard 
communication is needed. Furthermore, they highlighted that concentrated detergents may have 
more severe CLP classifications due to their concentration. If these products would have to carry 
prominent hazard warnings in advertising, consumers may be deterred from purchasing them and 
would instead choose diluted and less effective alternatives, bearing milder hazard classes, thereby 
undermining sustainability goals. In this regard, stakeholders also raised the consistency between 
the CLP regulation and the Packaging and Packaging Waste Regulation. While the future rules of 
the CLP will deter consumers to buy concentrated (and thus more hazardous) consumer products 
instead  choosing  larger  volumes  of  diluted  hence  less  hazardous  ones,  this  goes  against  the 
objectives of PPWR to foster the reduction of packaging and packaging waste. The detergents and 
home care sector noted that the PPWR fails to provide an incentive in advertising concentrated 
products  in  smaller  packaging  and  it  is  not  clear  whether  this  would  be  allowed  by  the  Green 
Claims Directive55. 

In addition, stakeholders expressed their concerns that the new rules  will discriminate chemical 
product categories being regulated under CLP (such as detergents, adhesives, paints) against non-
CLP regulated categories (such as cosmetics), because the quantity of hazard-related information 
would make these products less attractive, for instance on supermarket leaflets. 

Finally,  stakeholders  highlighted  confusion  over  whether  the  requirements  apply  to  various 
promotional  materials,  including  online  banners,  leaflets,  and  social  media  content.  To  ensure 
consistent  application  and  enforcement,  stakeholders  called  for  a  precise  and  harmonised 
definition of advertisement to be included in the legislation or in the supporting guidance. 

In addition to the qualitative feedback provided by companies and member states, the findings of 
a stakeholder poll held during Reality Check further substantiate the concerns raised. The results 
illustrate strong opposition to the advertisement requirements introduced in the revised Article 48 
and reinforce the call for simplification and alignment with other EU regulatory frameworks. 

A clear majority (59%) of respondents believe the new advertisement rules impose unjustified and 
disproportionate burdens on businesses. Only 3% consider the rules fully appropriate, while 20% 
regard them as moderately burdensome. This underscores the perception that the obligations are 
excessive relative to the intended safety benefits. 

The usefulness of hazard information in advertisements was also questioned. A majority (55%) do 
not  believe  that  including  this  information  in  advertisements  helps  consumers  make  better-
informed decisions. Only 35% believe it does. Instead, 87% of participants expressed confidence 

55  

Proposal for a Directive of the European Parliament and of the Council on substantiation and communication 
of explicit environmental claims (Green Claims Directive), COM/2023/166 final. 

Page 27 of 109 

 
 
 
 
that current product labels already provide adequate hazard information, supporting the argument 
that duplicating this data in advertisements is unnecessary. 

There  is  substantial  support  (80%)  for  simplifying  the  advertisement  provisions  to  reduce 
regulatory burdens. When asked about preferred simplification measures, 57% favoured retaining 
only the invitation to read the product label or Safety Data Sheet (SDS), 28% supported removing 
requirements solely for B2B advertisements, and 21% supported removing the requirement for all 
advertisements. 

Open-ended feedback from the poll included the excessive burden for B2B advertisements where 
SDS communication is already mandatory, inconsistency with the requirements laid down in other 
EU regulations such as the Biocidal Products Regulation, and the need for clearer definitions of 
‘advertisement’  in  the  CLP  context.  Many  also  warned  of  potential  consumer  confusion  and 
information overload if full hazard data is required in all advertisements formats. 

Some Member States showed flexibility to softening the rules on advertisements, narrowing the 
amount of required elements in advertisements to hazard pictogram, possibly supported by a signal 
word, together with  the  invitation  to  read product  information  on the label, or to  the statement 
indicating hazardous properties of the product, such as “This product contains chemical substances 
that  are  harmful  to  human  health  and/or  the  environment”.  They  expressed  the  opinion  that 
advertisements  requirements  would  contribute  to  strengthening  consumer  and  worker  safety 
through earlier risk warnings and will empower market surveillance authorities to tackle online 
sales  more  effectively.  Others  called  for  sticking  to  the  agreed  rolling-out  of  the  provisions  of 
Regulation  (EU)  2024/2865,  as  they  were  adopted  with  the  aim  of  ensuring  a  high  level  of 
protection  of  human  health  and  the  environment.  Overall,  Member  States  called  for  a  cautious 
approach when reopening the provisions that were recently agreed by co-legislators, calling for a 
thorough assessment supporting any legislative changes. 

NGOs  shared  their  concerns  about  the  revision  of  the  advertisement  rules,  indicating  that 
advertisement is by its nature intended to influence consumer choices. They consider it is therefore 
essential that consumers have access to all important information related to an advertised products 
as part of the advertisement and not only at the time of purchase when a decision may already have 
been made. They welcomed the new clearer rules on advertisement insofar that they will support 
informed  consumer  choice  including  by  preventing  product  presentations  that  could  mislead 
consumers e.g. by downplaying or omitting an advertised product’s hazardous properties. The new 
rules would also support Member States in their CLP enforcement activities. 

Proposed amendments and next steps  
In  light  of  the  proposed  simplification  agenda  and  in  order  to  reduce  disproportionate  costs 
identified by stakeholder feedback, the Commission proposes to simplify information requirement 
in advertisements for general public. This would result in the requirement for advertisements of 
chemicals to encourage customers to read the label and product information before use (i.e. by 
adding  a  sentence  “Always  read  the  label  and  product  information  before  use”)  without  the 
requirement to duplicate the hazard information from product labels. Furthermore, advertisements 
provisions  would  be  amended  to  limit  their  scope  to  chemicals  sold  to  the  general  public. 

Page 28 of 109 

 
 
 
Hazardous  substances  and  mixtures  traded  between  professionals  already  have  information 
requirements under Regulation (EC) No 1907/2006, so additional rules, as laid down in Regulation 
(EU) 2024/2865, would not be proportionate. 

Estimated cost savings 
Stakeholders provided a range of qualitative and quantitative estimates highlighting the significant 
financial and operational burdens of implementing the revised Article 48 requirements. These costs 
stem from increased complexity in adapting existing advertisement formats to include the full suite 
of CLP hazard elements, alongside necessary updates to supporting systems, staff, and procedures. 

A large company reported that due to the obligation to display hazard elements within the limited 
space of TV advertisements, at least two seconds of valuable consumer engagement time would 
be lost in a standard 20-second advertisement. They projected this would result in an annual loss 
of €30 million in advertising value for just one product category.  

For adhesives and sealants industry, according to the feedback received, the identified average cost 
of  new  requirements  on  advertisements  would  raise  to  €21 470  per  company.  This  is  not 
considering the cost of market loss when retailers would choose not to advertise at all or reduce 
advertisements for hazardous chemical products due to additional requirements. 

A mid-sized company estimated €200 000 annually in additional staff costs alone, driven by the 
need to expand marketing, compliance, and regulatory staff.  

Increased requirements for catalogues and printed advertisements would lead to greater production 
and  distribution  expenses.  One  example  cited  a  €50 000  increase,  with  others  reported  similar 
impacts. 

Costs  related  to  revising  contracts,  updating  documents,  adapting  compliance  processes,  and 
implementing new software solutions were commonly cited. In one Member State these costs were 
estimated in approximately €30 000 per year. Across EU stakeholders, these burdens likely total 
several hundred thousand euros annually. 

International, hence larger, companies noted that in the case they have joint marketing campaign 
covering EU and non-EU countries, they would need to split those campaigns into separate EU 
and non-EU formats, introducing design duplication and added production cost. While not fully 
quantified, they projected it could cost several million euros annually. 

c.  Other areas where stakeholders called for simplification which are addressed in the 

Commission proposal 

Stakeholder views 
In addition to topics outlined above, stakeholders raised a broad range of additional opportunities 
to simplify the CLP Regulation, which are listed below in this section. Most of the issues were 
highlighted  during  Reality  Check  and  later  confirmed  and  further  illustrated  by  stakeholder’s 
written contributions.  

Page 29 of 109 

 
 
 
 
“Stop-the-clock” for font size and other related requirements  

Many stakeholders called for freezing the transition period to the application of the new rules on 
label formatting laid down by Regulation 2024/2865. As many companies started their investments 
to comply with the new labelling rules, they claimed that a strong political signal is needed that 
the revision of the formatting rules is seriously considered.  

Differentiation between consumer products and B2B 

Significant  number  of  stakeholders  pointed  to  the  fact  that  industrial  and  professional  users 
(workers)  normally  rely  on Safety  Data Sheets  (SDS) for safe use conditions  and, in  industrial 
settings, on Standard Operating Procedures (SOP) and other documentation, rather than just labels. 
They  also  pointed  out  to  additional  obligations  from  Occupational  Safety  and  Health  (OSH) 
legislation that requires the employer to determine and assess the risks of hazardous chemicals, 
and to provide information and training for the workers in this regard. It was indicated that labels 
are  insufficient  to  convey  all  necessary  safe  use  information  in  industrial  and  professional  use 
settings. Workers must receive use instructions prior to starting to work with a chemical in question 
(i.e. before being able to physically inspect the label content).  

The stakeholders therefore considered certain requirements, particularly advertisements and online 
sales, being disproportionate and unnecessary in B2B context, with a questionable contribution to 
the increase of safety of workers and called for simplification and reduction of the requirements in 
this regard. It was also suggested by some stakeholders to allow broader use of digital labelling in 
industrial sector, allowing for a possibility to use English only on a physical label while providing 
the information in other languages on a digital label. 

Self-classification labelling deadlines  

Strong support emerged for aligning the six-month deadline for self-classified substances with the 
18-month timeline used for harmonised classifications. A number of stakeholders noted that such 
short timeline is extremely challenging, considering the time required for label production, which 
includes  document  preparation,  graphic  creation,  procurement  of  new  labels,  and  printing. 
Furthermore, such tight deadline could lead to product and label waste, undermining the Green 
Deal and packaging legislation.  

Companies  highlighted  that  the  increased  outsourcing  of  label  printing  will  further  extend  the 
supply chain for labels by 2 to 3 months on average, which makes compliance with updating labels 
within 6 months of self-classification a piece of challenge. 

Furthermore, it was highlighted that often certain label elements are pre-printed on the packaging. 
In case of a label change, the packaging must be re-designed, ordered, manufactured and supplied 
to the manufacturer of the substance or mixture in question. This process alone may take more 
than 6 months. In addition, the 6-month period to update the label also makes it very difficult to 
consume the existing  stock of pre-printed packaging  and of the  already packaged material  that 
normally cannot be repackaged or re-labelled. Consequently, upon the expiration of the 6-month 
period  to  update  the  label,  the  unused  pre-printed  packaging  and  unsold  materials  in  the  old 
packaging will have to be disposed of. 

Page 30 of 109 

 
 
 
At the same time several Member States expressed strong believe that 6 months should be enough 
for every actor in a supply chain and that the deadline is driven by the need to inform users about 
changes in the classifications as soon as possible. 

Unique Formula Identifier (UFI) for fuels  

Multiple actors requested flexibility in UFI requirements for fuels, where the diversity and mixing 
of supplies makes practical implementation extremely difficult. They also highlighted that since 
UFI can be printed directly on the packaging, outside the CLP labelling space, the formatting rules 
(especially black on white requirement and font sizes) should not apply to them. 

Stakeholders also strongly advocating for removing the requirement to provide UFI on fuelling 
pumps, highlighting that according to various poison centres, a UFI is not required when advising 
on emergencies and accidents involving standardised fuels and combustibles. They indicated that 
it is sufficient to provide to poison centres information on the type of fuel (e.g. diesel, gasoline, 
heating oil) to receive an adequate health response. Furthermore, it was indicated that the additive 
content is so low that it has no influence on the emergency advice and measures. 

Digital labelling  

Many  stakeholders  advocated  expanding  the  possibilities  of  digital  labelling,  especially  for 
professional  and  industrial  chemical  products,  to  complement  or  partially  replace  on-pack 
information. According to these stakeholders, extended digitalisation of CLP labels would alleviate 
part of the administrative burden triggered by the formatting rules laid down in Regulation (EU) 
2024/2865. In stakeholders’ view, use of digital label would reduce the use of physical materials 
and  remove  excessive  information  from  physical  labels  on  one  hand  and  would  simplify  the 
management,  update  and  distribution  of  information  on  the  other  hand,  thus  contributing  to 
sustainability and competitiveness of European industry.  

Among  the  information  that  could  be  moved  to  the  digital  label,  stakeholders  highlighted 
precautionary statements, that, in industry view, are disregarded or not understood by the majority 
of  consumers,  and  EUH  statements,  especially  for  non-hazardous  mixtures.  This  could  be 
complemented by the statement “more hazard information available online” to inform the users 
about the need to check digital label. 

At  the  same  time,  concerns  were  also  raised  by  member  states  and  NGOs  about  digital  divide 
issues and the practicality of accessing digital information during emergencies. 

Proposed amendments and next steps  
In light of the proposed simplification agenda and in order to remove administrative burden and 
disproportionate  requirements  identified  by  stakeholder  feedback,  the  Commission  proposes  to 
clarify and simplify the following requirements: 

Limiting rules on distance offers to public 

Similarly  to  the  approach  proposed  for  rules  on  advertisements,  it  is  suggested  to  limit  the 
provisions on distance sales offers to those offers aiming at general public only. This will bring 
more flexibility to B2B sector without, however, compromising health and safety of workers, as 

Page 31 of 109 

 
 
 
B2B customers usually receive a copy of the SDS even prior to any purchasing decision, as part 
of the material assessment and qualification process. 

Flexibility on labelling deadlines 

It is suggested to remove fixed deadline for the obligation to update the label, as it appeared to be 
not feasible to comply with due to the complexity of supply chains. In order to create flexibility 
for suppliers and create equal conditions for SMEs who often outsource label printing services, 
and taking into account the fact that preparation and production of fold-out labels is significantly 
longer that of standard 2D labels, the provision would require the labels to be changed without 
undue delay after new data was obtained by or communicated to a supplier. 

Derogations for smaller packages 

It is suggested to clarify provisions allowing for derogations from labelling requirements for small 
packaging,  especially  for  very  small  containers  under  10  ml.  The  amendments  would  allow 
economic  operators  to  reduce  information  required  to  be  provided  on  the  label  for  packaging 
containing smaller quantities of chemical substances or mixtures without the need to prove that 
this packaging is either in such a shape or form or is so small that it is impossible to meet full 
labelling requirements. In addition, derogations from labelling requirements for 10 ml packaging, 
introduced by Regulation 2024/2865 would be further clarified and simplified, especially for the 
substances and mixtures bearing milder hazards. 

Use of digital labels 

It is suggested to broaden the use of digital labelling introduced by Regulation (EU) 2024/2865. 
Suppliers  would  be  able  to  include  extra  contact  information  on  digital  labels  instead  of  the 
physical label, saving space on physical labels and making it easier to manage and update product 
details using digital technology, without, however, compromising health and safety of users. 

Labelling of fuelling stations 

It is suggested to simplify the labelling requirements for fuelling stations. Some label elements, 
such as nominal quantity and UFI, would not be required on fuel pumps, helping fuel suppliers 
meet the requirements without lowering safety standards. 

Postponing  the  entry  into  application  of  formatting  requirements  and  other  related 
provisions 

From the legal perspective it is not possible to freeze the implementation deadlines laid down by 
the  Regulation  2024/2865.  However,  a  proposal  to  postpone  the  entry  into  application  of  the 
provisions on mandatory formatting requirements, relabelling, advertisements and distance sales 
offers and labelling of fuel stations until 1 January 2028 was put forward by the Commission56 in 

56  

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  amending  Regulation  (EU) 
2024/2865 as regards dates of application and transitional provisions. 

Page 32 of 109 

 
 
 
 
order  to  ensure  legal  clarity  for  businesses  while  these  provisions  are  being  discussed  by  co-
legislators. 

d.  Other areas where stakeholders called for simplification which were not addressed by 

the Commission proposal 

In  addition  to  topics  outlined  above,  other  proposals  to  simplify  the  CLP  Regulation  were 
emphasised  by  the  stakeholders.  Most  of  these  issues  were  highlighted  during  Reality  Check 
workshop and later confirmed and further illustrated by stakeholder’s written contributions.  

These additional suggestions were not taken on board in the Commission proposals for which this 
Staff  Working  Document  is  developed.  While  some  suggestions  may  not  be  in  line  with  the 
objective  of  regulatory  simplification  without  reduced  protection  of  human  health  and  of  the 
environment, other proposed measures would not fit in a legislative proposal and could be better 
addressed outside legislative changes. For some suggestions too limited information was available 
to either identify the issue or to conclude that the options submitted would actually address the 
issue raised in a satisfactory way. 

Additional  work,  of  various  nature,  would  be  needed  for  all  those  options  not  reflected  in  the 
Commission proposal. 

“Stop the clock” for all regulatory changes to the CLP Regulation 

In  addition  to  the  call  to  stop-the-clock  for  the  application  of  label  formatting  rules,  some 
organisations representing industry also called for a postponement of the implementation deadlines 
of the new hazard classes introduced by the Regulation 2023/707, and rules on classification of 
mixtures containing more than one constituent substances (MOCS), in order to prepare better, gain 
more  experience  and  develop  additional  guidance.  It  was  highlighted  that  unified  application 
deadlines resulting from various CLP requirements would provide the opportunity to implement 
all  required  changes  simultaneously,  which  will  constitute  a  real  simplification  to  industry  and 
national authorities. 

Placing vs. making available on the market  

Calls were made to align CLP Regulation with other NLF product legislation by distinguishing the 
concepts of ‘placing on the market’ and ‘making available on the market’, to reduce unnecessary 
stock reclassification. 

It was highlighted that CLP Regulation does not differentiate between the terms “placing on the 
market”  (the  first  making  available  on  the  market)  and  “making  available  on  the  market”  (the 
subsequent  making  available  on  the  market),  unlike  products  legislation  covered  by  the  New 
Legislative Framework. It means that all changes introduced to CLP, including new harmonised 
classifications,  apply  to  all  chemical  products  already  in  the  supply  chain.  This  causes  a 
disproportionate cost as the foreseen deferred applicability period does not allow the sell off of the 
substances and mixtures that are already in the supply chain.  

Page 33 of 109 

 
 
 
However, several Member States highlighted that the concept of placing on the market in CLP is 
mirroring the same  concept  and logic of REACH regulation  –  both  being framework chemical 
legislations, that should stay aligned with each other. 

Poison Centre Notifications (PCN)  

Numerous stakeholders described the current poison centres notification system as burdensome 
and fragmented, with inconsistent national requirements and high associated costs, especially for 
small production batches or tailored-made products. The fees requested by some Member States 
make  the  placing  on  the  market  of  chemical  mixtures  in  those  Member  States  not  viable 
economically  for  products  placed  on  these  markets  in  very  low  tonnage.  The  need  for  the 
prohibition  to  impose  national  fees  for  PCNs  was  therefore  highlighted  by  a  number  of 
stakeholders. 

Strong  support  emerged  for  centralisation  of  PCN  submissions  via  ECHA.  Stakeholders 
highlighted that having ECHA PCN tool as the only tool for notifications, that would also allow 
for  submission  of  PCN  information  only  once,  would  simplify  and  eliminate  additional 
administrative and economic burden for industry to submit notifications to different portals and 
having discrepancy among the information/fees to be provided. Furthermore, several stakeholders 
suggested  the  PCN  submission  only  in  English,  highlighting  that  this  would  remove  excessive 
administrative burden and associated costs.  

Numerous stakeholders voiced the need of a comprehensive review of the current PCN system, to 
identify its drawbacks and potentials for simplification. 

Harmonised Classification and Labelling (CLH)  

Industry and NGO representatives highlighted the need to streamline the CLH process. Proposals 
included allowing better use of new data and clarifying exposure routes, while NGOs suggested 
an automatic updating of Annex VI based on scientific opinions.  

Industries  called  for  a  stronger  dialogue  at  the  early  stages  of  the  CLH  process,  to  ensure  that 
industries commitments to  tests  are fully included in  the CLH assessment  process. This  would 
ensure  that  all  relevant  scientific  data  is  considered  upfront.  Early  engagement  would  enable 
industry to  contribute to CLH assessment process  constructively, especially  in  cases  of  lack of 
relevant  data,  that  could  have  been  avoided  if  REACH  tests  had  been  completed,  which  could 
consequently help mitigating significant downstream impacts. 

Some NGO representatives further suggested to delete the need to justify the need of a CLH dossier 
for hazard classes other than those listed in Article 36(1) or (2). According to them, such a change 
would increase the number of CLH dossiers targeting environmental classification. 

Several  Member  States  reiterated  that  CLP  Regulation  already  foresees  possibilities  for  route-
specific classifications, if it can be conclusively proved that no other route of exposure exhibits 
the hazard. 

Page 34 of 109 

 
 
 
 
Mixture classification and expert judgment  

Stakeholders of certain chemical sectors highlighted that the recent revision of Article 9(4) of the 
CLP Regulation significantly restricts the use of expert judgment in the classification of chemical 
mixtures, limiting it solely to the selection of reference mixtures for bridging principles. While this 
may  streamline  enforcement,  it  imposes  disproportionate  costs  and  operational  burdens  on 
industry, particularly in sectors where formulations change frequently. Stakeholders warned that 
limitations  on  the  use  of  expert  judgment  and  weight-of-evidence  approaches  could  lead  to 
disproportionate and misleading classifications. One leading company identified an additional cost 
of more than €2.7 million in additional testing needed to derive appropriate classification. 

Stakeholders therefore voiced the need to reinstate the ability to apply expert judgment in mixture 
classification, thus ensuring a balanced approach that supports enforcement, scientific integrity, 
innovation and consumer protection. 

Additional derogation for ink cartridges  

Manufacturers  of  ink  cartridges  called  for  additional  labelling  derogations  as  these  cartridges 
usually  do  not  offer  enough  space  of  inner  packaging  for  the  limited  label  elements  required, 
especially in the context of new font sizes. These cartridges, being inserted in the printing devices, 
also cannot accommodate fold-out labels. It was highlighted that currently applicable derogations 
for 125 and 10 ml are mostly not applicable to such type of chemical products, especially the ones 
that are not classified but bear EUH statements. 

Derogations for on-site formulated mixtures 

SME representatives flagged the difficulties related to PCN notifications for mixtures prepared as 
individual fragrance compositions for aromatherapy and similar uses. It was indicated that due to 
the high variety of constituents and concentrations (the usual set of basic fragrances is 150 to 200 
substances, all being essential oils from plants) the poison centre notifications for such tailor-made 
mixtures become highly burdensome and almost impossible. In this regard, a call for a specific 
derogation (like the one currently foreseen for bespoke paints) from PCN notification requirements 
for on-site formulated mixtures in small containers less than 10 ml was made. 

At  the  same  time,  one  Member  State  highlighted  that  essential  oils  are  highly  concentrated 
substances  and  can  be  very  hazardous.  In  accordance  with  the  data  from  Poison  centre  in  that 
Member State, 820 incidents (462 concerning children) with essential oils were registered in 2023. 
There were symptoms in 576 cases, including 30 cases of serious or prolonged symptoms and 2 
cases of severe or life-threatening symptoms. It is therefore essential to ensure that CLP labelling 
and PCN notifications requirements are being followed. It was highlighted that new exemptions 
have been introduced by Regulation (EU) 2024/2865 for small packaging, that could facilitate the 
aromatherapy sector. 

Page 35 of 109 

 
 
 
 
 
2.  Issues and proposed amendments to Regulation (EC) No 1223/2009 on cosmetic products 

(CPR) 

Since  the  entry  into  application  of  the  Cosmetics  Products  Regulation  in  July  2013,  cosmetic 
manufacturers have increasingly raised concerns about the absence of transitional periods. These 
concerns became more prominent following the European Commission’s rejection of derogation 
requests for substances such as Zinc Pyrithione (ZnPt) and butylphenyl methylpropional (Lilial) -
commonly used ingredients in cosmetics – which were subsequently banned as of March 2022 
with  only  a  three-month  transitional  period.  This  decision  prompted  the  industry  to  regularly 
highlight difficulties in the practical application of the derogation criteria, as well as the challenges 
caused by the lack of sufficient transition time to adapt product formulations.   

Since 2023, concerns have grown  further with  the proposal  to  classify various natural  oils and 
constituents of natural complex substances as CMR substances. These include ingredients such as 
Tea  Tree  Oil,  hydroxycitronellal  (HCA),  L-carvone,  spearmint  oil,  cuminic  aldehyde,  and  p-
cymene57. Given that over 70% of cosmetic products placed on the EU market contain fragrances 
–  and  more  than  85%  of  those  include  ingredients  potentially  subject  to  such  bans  –  the 
implications  of  these  classifications  are  significant.  The  current  lack  of  specific  provisions 
addressing  natural  complex  substances  within  the  Cosmetic  Products  Regulation  has  therefore 
become a major source of concern for the EU fragrance industry.   

These  issues  have  been  the  subject  of  ongoing  discussions  between  the  cosmetics  industry, 
Member States, and the European Commission, including in the context of the Working Group on 
Cosmetic  Products58  as  well  as  through  bilateral  meetings.  The  Commission  has  received 
numerous  letters,  position  papers,  and  reports  from  industry  stakeholders,  all  underscoring  the 
growing  regulatory  burden.  Frequent  changes  in  regulatory  classifications  necessitate  repeated 
reformulations  and  adjustments  to  company  portfolios,  leading  to  rising  operational  and 
compliance costs. These pressures disproportionately affect small and medium-sized enterprises 
(SMEs) and risk undermining the competitiveness and innovation capacity of the EU cosmetics 
sector as a whole. 

To collect a first-hand experience from the stakeholders, a Reality Check on the CPR took place 
on 16 May 202559. The following issues and potential solutions were discussed. 

a.  Lack  of  clear  and  comprehensive  procedure  for  the  addition  of  colorants, 

preservatives, and UV filters to Annexes IV–VI of the CPR 

A substance can be used in cosmetic products as a colorant, preservative or UV filter only if it is 
listed in respective Annexes IV, V and VI to the CPR. 

57  

58  

59  

The  Committee  for  Risk Assessment  adopted  its  opinion  on  Cuminic Aldehyde  and  p-cymene  in  2024, 
opinion published on 9 January 2025. 
https://ec.europa.eu/transparency/expert-groups-register/screen/expert-
groups/consult?lang=en&groupID=1302  
The minutes of the Reality Check, are in Annex III to this document. 

Page 36 of 109 

 
 
 
 
Currently,  the  procedure  laid  down  in  Article  31(2)  of  the  CPR  is  used  to  add  colorants, 
preservatives and UV filters to Annexes IV, V and VI, respectively. However, specific provisions 
laying down the procedure for adding new colorants, preservatives or UV filters in the Annexes to 
the CPR upon request from the cosmetics industry, would enhance clarity and legal certainty and 
support  innovation  and  competitiveness  of  the  EU  cosmetics  sector. A  clear,  fair,  and  efficient 
procedure for adding new colorants, preservatives, and UV filters to the Annexes of the Cosmetics 
Regulation would reduce regulatory uncertainty and lower the risks associated with innovation. 
When  the  path  to  approval  is  predictable,  companies  are  more  likely  to  invest  in  research  and 
development, knowing they have a realistic opportunity to bring new substances to market and 
generate  returns  on  their  investment.  Faster  and  more  transparent  procedures  also  support  the 
development of safer, more effective, and more sustainable ingredients that align with consumer 
demands and EU policy goals. Ultimately, strengthening the EU regulatory framework in this way 
helps  retain  innovation  within  Europe,  making  the  internal  market  more  attractive  for  global 
investment and competitiveness. 

Stakeholder views 
Most participants of the Reality Check agreed that the current situation is unsatisfactory as Article 
14 of the CPR prohibits the use in cosmetic products of substances as colorants, preservatives or 
UV filters  which are not listed in  the relevant Annexes to the CPR, but it  does  not  set out  any 
procedure  according  to  which  those  substances  could  be  included  into  these  Annexes.  The 
establishing of a clear and specific procedure for the inclusion of colorants, preservatives and UV 
filters  in  Annexes  IV,  V,  and  VI  of  the  CPR,  respectively,  would  be  highly  beneficial  for 
stakeholders  (economic  operators  and  market  surveillance  authorities),  as  it  would  enhance 
transparency,  ensure  consistent  safety  assessments  and  streamline  the  authorisation  process 
overall. In particular, based on the Slido responses60, 67% of participants supported introducing 
such a procedure, citing improvements in clarity and regulatory certainty. Nearly 20% were also 
in favour but noted that certain aspects would still require further clarification. 

Proposed amendments and next steps  
To address the current lack of legal clarity and certainty, it is proposed to add an article outlining 
the  procedural  steps  involved,  the  role  of  the  European  Commission,  and  reaffirming  the 
responsibility of the SCCS in assessing the safety of any  substance which will be proposed for 
inclusion in the list of colorants, preservatives or UV filters.  

b.  Article 15: CMR substances – procedure for prohibition and requesting derogation 

from the ban  

Article  15  of  CPR  establishes  that  substances  which  have  been  classified  as  carcinogenic, 
mutagenic or reprotoxic (CMR) in Annex VI to CLP Regulation are prohibited for use in cosmetic 
products, unless an exemption has been granted. More specifically,  

•  Pursuant to Article 15(1) of the CPR, the use of a CMR substance of category 2, listed in 
Part 3 of Annex VI to the CLP Regulation, is prohibited in cosmetic products unless it has 
been evaluated by the SCCS and found safe for use in cosmetics. 

60  

197 participants answered the question via Slido 

Page 37 of 109 

 
 
 
 
•  Article 15(2) provides that the use of substances classified as CMR substances of 

category 1A or 1B, listed in Part 3 of Annex VI to the CLP Regulation is prohibited in 
cosmetics, except when the following criteria are cumulatively fulfilled: 

a)  the substance complies with the food safety requirements 
b)  there are no suitable alternatives 
c)  the application has been made for a particular use of the product category with a 

known exposure, and 

d)  the substance has been evaluated and found safe by the SCCS considering the 

cumulative exposure from other sources outside cosmetics. 

As  regards  the  deadline  for  the  implementation  of  the  exemption  procedure  for  CMR  1A/1B 
substances, fourth subparagraph of Article 15(2) of the CPR provides that the Commission shall 
amend the relevant Annexes to this Regulation within 15 months of the “inclusion of the substances 
concerned in Part 3 of Annex VI to Regulation (EC) No 1272/2008”. 

Recent  experience  has  revealed  several  challenges  and  limitations  within  the  current  system, 
suggesting  that  the  process  for  prohibiting  or  restricting  substances  -  following  the  exemption 
procedure - is not operating as effectively or efficiently of as intended.  

Growing number of cosmetic ingredients receiving harmonised classification as CMRs  

In  2024, The  Committee  for  Risk Assessment  (RAC)61  adopted/published  several  opinions  for 
which CMR 1B classification was proposed. Some of these substances are widely used in cosmetic 
products. For example, Piperonal62 is a key ingredient in fine fragrances and signature perfumes, 
p-cymene63 is a component found in more than 360 essential oils, and Tea Tree Oil64 is used in 
numerous cosmetic formulations. This trend is expected to continue as an increasing number of 
non-industrial  chemicals  are  being  proposed  for  harmonised  classification  as  CMR  substances. 
Moreover,  the  grouping  approach  recently  introduced  will  further  accelerate  the  pace  at  which 
substances are subject to harmonised classification including as CMR, intensifying the regulatory 
impact with significant negative effects on the cosmetics sector considering the current outdated 
provisions of Article 15. 

Lack  of  legal  certainty:  Absence  of  clear  timelines  for  a  derogation  requests  and  transitional 
periods  

Businesses argue that the absence of clear regulatory rules, well-defined timelines, and justified 
transitional periods creates significant  legal  uncertainty. This  undermines investment  decisions, 
often  forcing  companies  to  make  assumptions  about  whether  a  substance  will  receive  a  CMR 
classification and subsequently be banned from use in cosmetic products. Moreover, businesses 
highlighted  that  this  regulatory  ambiguity/uncertainty  hinders  their  ability  to  plan  and  to  scale 

61  
62  

63  

64  

https://echa.europa.eu/about-us/who-we-are/committee-for-risk-assessment 
Also known as Heliotropine, RAC opinion was adopted on 6 June 2024;  https://echa.europa.eu/registry-of-
clh-intentions-until-outcome/-/dislist/details/0b0236e187205ab2  
RAC  adopted  its  opinion  on  18  November  2024;  https://echa.europa.eu/registry-of-clh-intentions-until-
outcome/-/dislist/details/0b0236e188d24acd  
Also known as Melaleuca alternifolia. RAC opinion was published on 10 September 2024.  

Page 38 of 109 

 
 
 
 
operations effectively – an issue that disproportionately affects SMEs, for whom strategic planning 
and resource allocation are particularly critical.  

Insufficient timeframe for submission of derogation request  

The  submission  by  industry  to  the  Commission  services  of  a  complete  file  for  a  possible 
exemption currently relies solely on the RAC opinion, which proposes a potential classification 
under the CLP Regulation. However, such opinion is not legally binding and may differ from the 
final classification adopted under the CLP Regulation65. The lack of legal certainty regarding the 
possible  classification  hinders  economic  operators  from  a  timely  submission  of  an  exemption 
request  and  jeopardise  the  process  when  a  dossier  submission  may  be  based  on  a  different 
classification.  Moreover,  according  to  the  current  Guidelines  on  Article  15,  the  deadline  for 
industry  to  submit  a  complete  exemption  file  -  set  at  no  later  than  six  months  following  the 
publication of the RAC opinion - has proven to be excessively short. This timeframe is insufficient 
for the preparation of a comprehensive dossier and for conducting a thorough safety assessment 
by the Scientific Committee on Consumer Safety (SCCS). 

Lack of transitional periods 

The  current  lack  of  transitional  periods  for  the  implementation  of  Article  15  provisions, 
demonstrates that it is practically impossible to withdraw cosmetic products from the market in an 
effective and efficient manner.  

For  CMR  Category  1  substances,  Article  15(2)  of  the  CPR  stipulates  a  clear  and  binding 
timeline. The Commission is required to amend the Annexes to the CPR within 15 months of the 
inclusion of the substances in  Part 3 of Annex VI of the  CLP Regulation. This  amendment 
process  follows the  regulatory procedure with  scrutiny, as described in  Article 32(3) of  the 
CPR. This strict timeline ensures timely regulatory action for substances that present the highest 
potential risk for human health66. 

In contrast, for CMR Category 2 substances, Article 15(1) of the CPR does not specify a precise 
timeline for regulatory action. It states: ‘The use in cosmetic products of substances classified as 
CMR substances of Category 2 under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall 
be prohibited. However, a substance classified in Category 2 may be used in cosmetic products 
where the substance has been evaluated by the SCCS and found safe for use in cosmetic products. 
To  these  ends,  the  Commission  shall  adopt  the  necessary  measures  in  accordance  with  the 
regulatory  procedure  with  scrutiny  referred  to  in  Article  32(3)  of  this  Regulation.’  [emphasis 
added]. 

65  

66  

Such divergences, though not frequent, do occur, as the Commission may take into account additional policy, 
legal, or socio-economic considerations when deciding on the final harmonised classification 
CMR  Category  1  substances  include  both  proven  and  presumed  carcinogens,  mutagens,  or  reproductive 
toxicants. More specifically, category 1A includes substances known to have CMR effects in humans based 
on strong evidence (proven), while category 1B includes substances presumed to have CMR effects based on 
animal studies or other relevant evidence (presumed). 

Page 39 of 109 

 
 
 
 
Figure 1: Timeline of adoption and entry into application of a ban/restriction on CMR substances under Article 15(2) 
of the CPR and Guidelines on Art. 15. 

ATP (Adaptation to Technical Progress) corresponds  to the Commission delegated Regulation amending Part 3 of 
Annex VI to the CLP Regulation.  

Despite the legal distinction between Category 1 and 2 substances in the CPR, the Commission 
has  been  preparing  regulations  amending Annexes  to  the  CPR  banning  or  restricting  the  CMR 
substances  from  use  in  cosmetics  (also  referred  to  as  ‘CMR  Omnibus Acts’)  within  15-month 
timeline  as  provided  in Article  15(2)  for  amending  the Annexes  of  the  CPR,  regardless  of  the 
classification  category  (see  figure  1).  According  to  the  current  practice  which  follows  the 
interpretation of Article 15 of the CPR, the CMR Omnibus Act on CMR enters into application at 
the same day as the relevant delegated act under the CLP Regulation (as shown in figure 1). While 
this  approach  ensures  a  degree  of  consistency,  it  introduces  a  discrepancy  between  the 
timeframes given to economic operators for compliance with the CLP and CPR: 

•  Under  the  CLP  Regulation,  the  date  of  entry  into  force  of  the  delegated  act  informs 
economic operators that they have 18 months to prepare, while compliance is required 
from the date of application of the respective Adaptation to Technical Progress (ATP).  
•  Under the CPR, the Commission regulations (CMR Omnibus Acts) amend the Annexes to 
the  CPR,  but  not  provide  any  timeframe  for  economic  operators  to  prepare  for  their 
application.  It  should  be  also  noted  that  economic  operators  for  cosmetic  products  are 
further downstream users of the economic operators affected by CLP (i.e., raw material 
providers, manufacturers, etc.) and depend on the latter to acquire updated information on 
the materials they use in cosmetic products prior to making any changes in their products. 
This creates a misalignment that leads to legal uncertainty and operational challenges 
for stakeholders. 

Page 40 of 109 

 
 
 
 
 
 
The  table  below  demonstrates  the  lack  of  transitional  periods  for  businesses  to  adapt  to  regulatory 
measures. 

Regulation amending 
Annexes to the CPR 

Date of entry 
into force  

Date of application 

Period between the 
entry into force and 
application 

Regulation 2019/831 

12/06/2019 

12/06/2019 

0 months 

Regulation 2019/1966 

18/12/2019 

11/06/2019 and 
1/05/2020 

-6 and 6,5 

Regulation 2021/850  

17/06/2021  

01/10/2021  

3,5 months 

Regulation 2021/1902 

23/11/2021  

01/03/2022 

3,5 months 

Regulation 2022/1531 

06/10/2022  

17/12/2022 

2,5 months 

Regulation 2023/1490 

09/08/2023 

1/12/2023 

3,8 months 

Regulation 2025/877 

02/06/2025 

1/09/2025 

3 months 

Simplifying derogation criteria for substances classified as CMR 1 A or 1B  

Article 15(2) provides that the use of substances classified as CMR substances of category 1A or 
1B, listed in Part 3 of Annex VI to the CLP Regulation is prohibited in cosmetics, except when the 
following criteria are cumulatively fulfilled: 

a)  the substance complies with the food safety requirements 
b)  there are no suitable alternatives 
c)  the application has been made for a particular use of the product category with a 

known exposure, and 

d)  the  substance  has  been  evaluated  and  found  safe  by  the  SCCS  considering  the 

cumulative exposure from other sources outside cosmetics. 

Criterion  (a)  requires  that,  for  a  CMR  substance  to  be  used  in  a  cosmetic  product  despite  its 
classification, it must also comply with food safety standards. The assumption used in this case is 
that if a substance is safe enough for ingestion, it should theoretically be safe for external, topical 
application,  which  typically  involves  lower  systemic  exposure.  However,  this  requirement  has 
proven problematic for several reasons: 

Cosmetic and food products are fundamentally different in terms of route, frequency, and context 
of  exposure.  Cosmetics  are  applied  externally,  often  in  lower  concentrations,  whereas  food 
involves  ingestion  and  metabolic  processing.  This  mismatch  in  exposure  profiles  means  that 
compliance with food safety requirements does not necessarily correlate with safety in cosmetics 
or vice versa. In many cases, substances used in cosmetics are not intended to be ingested and may 

Page 41 of 109 

 
 
 
 
never be assessed by the European Food Safety Authority (EFSA), the authority responsible for 
food safety evaluations. In particular, if a substance is not authorised or evaluated for use in food, 
it can be disqualified for derogation in cosmetics regardless of its actual safety profile for topical 
use. 

In  essence,  this  criterion  creates  a  misalignment  between  regulatory  frameworks  and  has  been 
viewed by industry as scientifically inappropriate and legally rigid, especially when the substance 
has been deemed safe for topical use by the SCCS. Many stakeholders have therefore called for its 
removal or reformulation, arguing that it adds burden without improving consumer protection. 

Criterion (b) requires the applicant to demonstrate that no technically and economically feasible 
alternatives exist that would perform the same function in the specific cosmetic application. The 
rationale is that derogations for CMR substances should only be granted as a last resort, where the 
substance is necessary for performance or stability and no safer options are available.  

Nevertheless, the definition of “suitable” alternatives is unclear: It is not always specified whether 
alternatives must be equivalent in function, efficacy, cost, or compatibility with other formulation 
components.  In  addition,  the  assessment  of  alternatives  is  often  subjective  or  context-specific, 
especially  in  high-performance  products  like  sunscreens,  hair  dyes,  or  preservatives,  where 
technical performance and formulation stability are crucial. Furthermore, the economic feasibility 
is rarely quantified, but in practice, industry may face significant reformulation costs or loss of 
product effectiveness if forced to switch to inferior or possibly costlier alternatives. Lastly, this 
requirement may also discourage innovation or delay access to market for products that rely on 
well-understood and previously authorised ingredients, even when they pose no real safety concern 
at the intended use level. 

Therefore, while it is reasonable to encourage the use of safer alternatives, the current application 
of criterion (b) can be ambiguous and overly restrictive. Stakeholders have proposed that greater 
clarity  be  provided  on  how  alternatives  should  be  assessed,  and  that  the  criterion  should  focus 
more on whether the substance can be safely used in the specific context, rather than presuming 
that presence of any alternative is sufficient to justify prohibition. 

Criterion ‘c’ refers to the requirement that any request for derogation must specify the intended 
use within a defined product category, along with a clear understanding of how consumers will be 
exposed to the substance (important for the assessment of criterion ‘d’). 

The  ‘particular  use’  implies  that  the  derogation  request  must  be  specific  about  the  intended 
cosmetic use (i.e., function or application) of  the substance within a cosmetic product. The use 
should be clearly defined, such as whether the substance will be used for example in a face cream, 
shampoo,  deodorant,  lipstick,  or  sunscreen,  etc.  Broad,  non-specific  applications  like  ‘for  all 
cosmetic products’ would not meet this criterion. 

The ‘product category’ of cosmetic products must be identified for which the substance will be 
used. This  is  important  since  product  categories  in  cosmetics  have  different  levels  of  exposure 
based on the type and (e.g., rinse-off, leave-on products, etc.). 

Page 42 of 109 

 
 
 
The ‘known exposure’ indicates that there must be a clear understanding and quantification of how 
and to what extent consumers will be exposed to the substance. This includes factors such as: 

• 
• 
• 
• 
• 

the frequency and duration of use (e.g., daily, occasional) 
the concentration of the substance in the product 
the amount of product applied (typical quantity per application) 
the route of exposure (dermal, oral, inhalation), and 
the  target  population  (general  population,  vulnerable  groups  like  children  or  pregnant 
women, etc.) 

In practice, this criterion ensures that the safety assessment and the derogation decision are based 
on realistic, specific and defined use scenarios, rather than hypothetical  or generalized uses. In 
addition,  this  information  enables  the  Scientific  Committee  on  Consumer  Safety  (SCCS)  to 
conduct a focused safety evaluation that considers the actual exposure risk for consumers. It helps 
avoid unnecessary risks by ensuring that the substance’s safety is carefully considered by the SCCS 
in the specific context of its intended use. 

This derogation criterion has been viewed as confusing, since it is already considered (as such) in 
the SCCS safety assessment. A clearly defined scope of application -particularly with regards to 
product categories- is already a prerequisite for any meaningful safety evaluation by the SCCS. As 
such,  maintaining  this  requirement  as  a  separate,  self-standing  criterion  appears  redundant  and 
could be removed without adverse impact on consumer safety.  

Clarifying the regulatory approach to natural complex substances containing CMR Cat. 1 or 2 
constituents 

labelling  of  several  substances, 

In  May  2023  the  European  Chemicals  Agency  (ECHA)  received  a  proposal  for  harmonised 
classification  and 
including  ‘p-cymene;  1-isopropyl-4-
methylbenzene’ (‘p-cymene’). This substance is currently listed in Annex VI to the CLP Regulation 
with the following hazard classification: ‘Flammable Liquid Category 3, Acutely Toxic Category 
3,  Aspiration  Toxicity  Category  1,  Hazardous  to  the  aquatic  environment  -  Chronic  Hazard, 
Category 2’. In May 2023 submission it was proposed to add ‘Reproductive Toxicity Category 1B 
(H360FD)’ to the existing classification. 

P-cymene  can  be  synthetically  produced  (manufactured)  but  it  is  also  naturally  present  as  a 
constituent  in  around 350 plant extracts  at  different  concentrations,  for example in Thyme oil: 
20%,  Cumin  oil:  9,7%,  Lemon  oil:  0,5%,  Neroli  (bigarade)  oil:  0,3%,  as  well  as  in  Lavender, 
Bergamot,  Mint,  Rosemary  and  Eucalyptus  oils.  P-cymene  is  also  present  in  food  like  carrots, 
oranges, grapefruits, tangerines, raspberries and many others. 

Ingredients of plant origin (i.e. plant extracts) are widely used in cosmetic formulations – not only 
in ‘natural’ or ‘organic’ products, but also in the vast majority of cosmetic products  containing 
fragrance concentrates. Beyond their use in perfumes, the cosmetics industry reports that plant-
based compounds represent approximately 32% of all ingredients used across the entire range of 
cosmetic products.   

Page 43 of 109 

 
 
 
 
The  CLP  Regulation  differentiates  between  a  ‘substance’  and  a  ‘mixture’. A  substance  can  be 
‘mono-constituent’ or can contain more than one constituent (so called a ‘complex substance’). 
Plant  extracts  that  are  not  chemically  modified  form  a  distinct  subcategory  within  complex 
substances. 

Article 15 of the CPR establishes a direct link between the harmonised classification of a substance 
as a carcinogenic, mutagenic, or reprotoxic (CMR) substance in categories 1A, 1B, or 2 and the 
prohibition or restriction of its use in cosmetic products. However, the CPR although it includes 
and defines the terms ‘substance’ and a ‘mixture’, it does not include the term ‘complex substance’.  

Consequently, it could be concluded that if a substance with harmonised classification as a CMR 
1A, 1B, or 2 is present as a constituent in a natural complex substance, the prohibition established 
under Article  15  of  the  CPR  applies  specifically  to  the  substance  itself,  and  not  to  the  natural 
complex substance in which it is contained. Currently, decisions regarding the regulatory treatment 
of such multi-constituent natural complex substances ultimately rely on the interpretation of the 
CPR, leading to a lack of legal certainty for both regulators and industry stakeholders. To address 
this  ambiguity,  it  is  proposed  to  add  a  paragraph  to Article  15  clarifying  that  the  harmonised 
classification of a constituent does not lead to a ban on natural complex substances containing a 
CMR  substances  as  its  constituent.  However,  to  ensure  the  protection  of  human  health,  the 
Commission will be required to request the SCCS opinion on the safety of such natural complex 
substances  containing  a  constituent  classified  as  a  CMR  and  to  take  the  regulatory  measures 
following this scientific opinion.  

When the cosmetic industry representatives participating in the “Reality Check” workshop were 
asked to point to one out of five solutions which have the biggest impact, 25% of them chose that 
clarifying  the  approach  to  natural  complex  substances  would  simplify  business  operations  and 
reduce their burden. Only the suggestion to introduce transitional periods received equally high 
score.  

Establishing a Ban Triggered by CMR Classification Solely on the Basis of Dermal Exposure 

Article  15  of  the  CPR  prohibits  substances  based  on  the  harmonised  classification  as  a  CMR 
category 1A, 1B or 2. However, it does not take account of the route of exposure this classification 
may have. It could be that a substance has CMR properties only if it is inhaled or digested, but not 
if it comes into contact with the human skin (i.e., dermal exposure).  

Stakeholder views 
During the Reality Check stakeholders broadly supported the possible changes to Article 15 of the 
CPR relevant to the food criterion, particular use and assessment of suitable alternatives. Some 
participants emphasised the need for reassurance that any simplification initiative in the area of 
cosmetics should not compromise the core policy objectives of the CPR. Specifically, participants 
underlined that the harmonised classification of a substance as a CMR must continue to trigger a 
ban  for  its  use  in  cosmetics,  and  that  derogations  from  this  ban  should  only  be  granted  in 
exceptional  cases.  Others  stressed  that  the  CPR  must  continue  protecting  consumers  from  the 
harmful chemicals and cautioned against excessively long transitional periods, warning that they 
could prolong consumers exposure to hazardous substances. 

Page 44 of 109 

 
 
 
Responses to Slido questions indicated that, among five simplification measures, the top three - 
introducing  transitional  periods,  clarifying  the  approach  to  natural  complex  substances,  and 
simplifying the criteria for derogations - were seen as the most impactful in reducing regulatory 
and administrative burdens on the cosmetics industry. Specifically, 48% of respondents believed 
that all five proposals were to significantly streamline business operations, while 31% considered 
the benefit to be as moderate. Only 6% felt the impact would be marginal or negligible  

Proposed amendments and next steps  

Several changes could be made in Article 15 of the CPR to simplify it and reduce the burden on 
businesses  without  affecting  the  high  level  of  protection  of  human  health,  meaning  that  the 
harmonised classification of a substance as CMR category 1 or 2 would continue to  trigger its 
prohibition in cosmetic products, unless a derogation request is submitted, and the revised/updated 
derogation criteria are met. 

i.Establishing a fixed period for submission of derogation requests 
The  current  CPR  does  not  foresee  a  timeline  for  businesses  to  submit  a  derogation  request. 
According to the so called ‘CMR Guidelines’67, a submission should be made within six months 
after  the  publication  of  the  RAC  Opinion.  To  provide  greater  legal  certainty,  the  CPR  should 
explicitly set the deadline for the submission of derogation request which should not exceed three 
months after the entry into force of the changes to Part 3 of Annex VI of the CLP Regulation. It 
will  allow  business  operators  several  months  to  prepare  and  collect  data  and  evidence 
demonstrating compliance with the derogation criteria (see figure 2). 

ii.Introducing transitional periods for compliance with new bans or restrictions 

To enhance legal certainty and enable businesses to take appropriate measures, the CPR should 
introduce realistic adaptation timelines – such as 12 months for products placed on the market and 
24 months for products available on the market – following the entry into force of the amendments 
to the relevant Annexes to the CPR (see figure 2).  

Figure 2: Planned timeline of adoption and entry into application of a ban/restriction on CMR substances 
under Article 15(2) of the CPR after amendments. 

67  

https://ec.europa.eu/docsroom/documents/39989 

Page 45 of 109 

 
 
 
 
iii. Simplifying derogation criteria under Article 15(2) 
Among the derogation criteria of Article 15(2), two criteria could be revisited: 

a)  the compliance with the food safety requirements and 
b)  the application which must  be  made  for  a particular use of the product  category with  a 

known exposure. 

Several  stakeholders  consider  that  the  food  safety  criterion  becomes  a  barrier  to  the  use  of 
substances that are not present in food but  are demonstrably safe when applied on the external 
parts of the human body.  

As regards the second criterion, it should be merged with  criterion (d) ‘the substance has been 
evaluated and found safe by the SCCS considering the cumulative exposure from other sources 
outside cosmetics.  

iv. 

Clarifying the regulatory approach to natural complex substances 

containing CMR Cat. 1 or 2 constituents 

For the purpose of legal clarity and certainty, the CPR should provide that when a constituent of a 
multi-constituent substance has been classified as a CMR substance of categories 1A, 1B and 2, 
the prohibition from Article 15 would not apply to such a substance if it was extracted from plants 
or  plant  parts  and  which  are  not  chemically  modified.  However,  to  address  possible  safety 
concerns, the Commission should request the SCCS to provide its opinion on the safe presence of 
the constituent classified as CMR substance in the plant extract used in cosmetics.  

v. 

Establishing a Ban Triggered by CMR Classification Solely on the Basis of 

Dermal Exposure 

Page 46 of 109 

 
 
 
 
 
The link between the route of exposure, the harmonised classification as a CMR category 1A, 1B 
or  2  and  the  ban  in  cosmetics  will  be  established  so  that  the  harmonised  classification  of  a 
substance as a CMR will trigger the ban under Article 15 of the CPR only if the scientific evidence 
on which the classification is based shows that the CMR properties are due to a dermal exposure. 
Consequently,  if  a  substance  is  hazardous  and  shows  CMR  properties  only  if  it  is  ingested  or 
inhaled, it does not create a hazard for human health and such harmonisation should not trigger a 
ban. 

c.  Prenotification requirement for products containing nanomaterials (Article 16) 
According  to  the  CPR,  products  containing  nanomaterials  (other  than  colorants,  UV-filters, 
preservatives  or  nanomaterials  in  conformity  with  the  requirements  in  its Annex  III)  must  be 
notified  to  the  Commission  six  months  prior  to  being  placed  on  the  market,  unless  they  have 
already been placed on the market by the same responsible person before 11 January 2013. This 
obligation is in addition to the notification obligation that applies to all cosmetic products under 
Article 13 CPR. 

Table: number of products notified to the CPNP containing nanomaterials under Article 16 of the 
CPR and number of all notifications based on Article 13 of the CPR. 

Year/number 
of 
notifications 
to the CPNP 
Art. 13 
notifications 
of cosmetics 
with nanos 

Art. 16 pre-
notification 

2014 

2015 

2016 

2017 

2018 

2019 

2020 

2021 

2022 

2023 

2024 

3925  3476  3573  3731  3632  4034  3265  3824  2755  2465  2333 

144 

74 

265 

131 

200 

175 

137 

222 

57 

76 

51 

According to the cosmetics industry, the pre-notification process of one product takes 3 working 
days  of  1  FTE.  Therefore,  in  2024,  when  the  number  of  prenotifications  was  the  lowest,  the 
administrative costs for the industry amounted to €36 00068 while in 2016, with the highest number 
of  prenotifications,  this  amount  was  substantially  higher  and  reached  €187 000.69  This  double 
notification  of  products  containing  nanomaterials  seems  no  longer  justified  as  the  cosmetic 
products containing nanomaterials should not be considered less safe than other cosmetic products 
as they are subject to the appropriate safety assessment under the responsibility of the responsible 
person. Furthermore, the current specific provision which enables the Commission to request the 

68  
69  

51 notifications *24 hours= 1224 hours per year, 1224 * 29.40 = approximately €36 000 per year 
265 notifications *24 hours= 6360 hours per year, 6360 * 29.40 = approximately €186 984 per year or 187, 
000 

Page 47 of 109 

 
 
 
 
 
opinion of the SCCS on the safety of nanomaterial in case of safety concerns will not be affected 
by the amendments nor the requirement that the responsible person must provide any necessary 
data to the Commission on its request.  

This  approach  is  aligned  with  the  conclusions  of  the  Commission  report  on  the  use  of 
nanomaterials in cosmetics70 

Stakeholder views 
This  pre-notification  requirement  for  cosmetic  products  containing  nanomaterials  has  been 
considered  burdensome.  Suggestions  for  improvement  included  simplifying  the  notification 
processes  by  relying  on Article  13  of  the  CPR  to  reduce  industry  costs  without  compromising 
product safety. 

According  to  Slido  results,  approximately  61%  of  respondents  agreed  that  the  pre-notification 
requirements impose significant and disproportionate burdens and costs on the cosmetic industry. 
Meanwhile, 14% considered the burden to be manageable, and 3.2% believed the current process 
is appropriate and does not result in unnecessary costs.  

Proposed amendments and next steps  
The prenotification obligation laid down in Article 16 of the CPR could be therefore removed to 
reduce unnecessary burden. In order to ensure the same level of consumer safety and appropriate 
enforcement, the requirements related to the provision of the relevant pieces of information will 
be  transferred  to Annex  I  to  the  CPR  so  that  the  cosmetic  product  safety  report  contains  the 
adequate description of the nanomaterials used in a given cosmetic product. 

d.  Publication of the glossary of cosmetic ingredients in the Official Journal of the EU 
Article 33 of the CPR provides that for the purpose of labelling cosmetic products placed on the 
EU market, the Commission must compile and update a glossary of common ingredient names, 
via  a  Commission  Decision,  taking  into  account  of  internationally  recognised  nomenclature 
including INCI names.  

To date, such glossaries have been published in the Official Journal of the EU in 2019 and 2022. 
However, the current approach to updating the glossary has become suboptimal for the following 
reasons: 

−  Slow pace of updates: the majority of common ingredient names used in cosmetics are 
based on the International Nomenclature of Cosmetic Ingredients (INCI), developed by the 
Personal Care Products Council (PCPC). Although new INCIs are regularly introduced or 
revised by the PCPC, updates to the EU glossary occur only  approximately every three 

70  

Report from the Commission to the European Parliament and the Council on the use of nanomaterials in 
cosmetics  and  on  the  review  of  Regulation  (EC)  No  1223/2009  on  cosmetic  products  as  regards 
nanomaterials; 
https://eur-lex.europa.eu/legal-
403 
content/EN/TXT/?uri=CELEX%3A52021DC0403 

COM(2021) 

final, 

Page 48 of 109 

 
 
 
 
 
years. This delay hinders timely adaptation to technical and scientific developments within 
the sector. 

−  additional burden and duplication of effort for competent authorities and business: 
Given  the  legal  status  of  the  Commission  Decision  establishing  the  list  of  common 
ingredients  names,  both  the  market  surveillance  authorities  and  business  operators  are 
required to ensure that ingredient names used on product labels align precisely with those 
listed in the Decision. To facilitate and streamline this process, stakeholders often refer to 
the  CosIng  to  identify  the  appropriate  INCI  name,  which  must  then  be  cross-checked 
against the official entry in the Commission Decision -resulting in redundant administrative 
effort. 

The current approach leads to additional work and unnecessary burden while the internationally 
recognised nomenclature of common ingredient names is publicly available and regularly updated 
on the website of the Personal Care Products Council (PCPC). 

Stakeholder views 
The  Commission  sought  stakeholders’  views  on  the  continued  relevance  of  the  glossary  of 
common ingredient names, proposing that it could be replaced by a reference in the CPR to the 
internationally  recognised  cosmetic  ingredient  nomenclature.  During  the  discussion,  many 
participants  expressed  a  preference  for  retaining  the  glossary  as  a  legally  binding  source  of 
ingredient names. However, they recommended that it be made available in an electronic format – 
integrated into the CosIng database – to enable more frequent updates and significantly enhance 
user experience.  

Some  stakeholders,  however,  argued  that  the  glossary  is  either  no  longer  necessary  or  would 
require substantial improvements to maintain its usefulness. These diverging views were reflected 
in the Slido poll results: 50.2% of respondents considered the glossary to be of limited value and 
believed  it  could  be  discontinued  without  major  consequences.  Conversely,  41%  supported 
retaining the glossary or acknowledged its usefulness, but emphasised the need for improvements 
in accuracy, format and the frequency of updates.  

Proposed amendments and next steps  
A solution could be to remove the obligation to compile the glossary and enable businesses and 
competent  authorities  to  rely  on  the  internationally  recognised  nomenclature  and  relevant 
information provided electronically in a Commission database71. 

e.   Reporting on market surveillance actions (Article 22) 

According to Article 22 of the CPR, Member States must perform appropriate checks of cosmetic 
products and periodically review and assess the functioning of their surveillance activities. Such 
reviews should be carried out at least every four years and the results should be communicated to 
the other Member States and the Commission. 

71  

Existing  Cosmetic  Ingredients  database  (CosIng)  provides  information  on  cosmetic  substances  and 
ingredients including frequently updated common ingredients names.   

Page 49 of 109 

 
 
 
 
Over the years different networks and tools have been created to inform about and coordinate the 
market surveillance activities by the competent authorities: 

• 

the  EU  Product  Compliance  Network  (EUPCN)  has  been  established  to  structure  the 
coordination and cooperation between market surveillance authorities in EU countries,  
•  PEMSAC  group  facilitates  the  exchange  of  information  among  the  market  surveillance 

authorities responsible for cosmetics, 

•  The ICSMS (Information and Communication System for Market Surveillance)72 functions 
as  the  comprehensive  communication  platform  for  market  surveillance  on  non-food 
products and for mutual recognition for goods. 

The ICSMS allows information on investigated products (test results, product identification data, 
economic  operator  information,  accident  information,  information  on  measures  taken  by 
surveillance authorities etc.) to be quickly and efficiently shared between authorities. It supports 
market surveillance activities, by providing a register for their documentation, the identification of 
the products inspected and the results of the tests/checks. 

Assuming  that  the  collection  of  data  is  already  performed,  the  analysis  of  such  data  and  the 
preparation  of  the  respective  report  would  take  10  days  for  1  FTE,  the  savings  will  amount  to 
€129 36073 yearly. 

Stakeholder views 
Some participants cautioned against introducing measures that could weaken EU-level oversight 
of national market surveillance activities. This cautious stance was  reflected in responses to the 
Slido question: ‘Do you consider that the deletion of the reporting obligations would reduce burden 
on competent  authorities?’ Most respondents  did  not  express  a clear opinion. However,  among 
those who did respond, half believed that removing the obligation would result in significant or 
moderate reduction in administrative burden. 

Proposed amendments and next steps  
With the introduction of ICSMS, the reporting obligation introduced in Article 22 of the CPR has 
become redundant and therefore, it should be removed. 

Estimated cost savings 
Business  stakeholders  have  long  expressed  concerns  that  the  current  legislative  framework  for 
cosmetics - in particular Article 15 of the CPR- is not adequate in addressing the growing number 
of harmonised  classifications  of substances  as  CMR category 1A, 1B or  2, many of which are 
commonly used in cosmetic products. 

They claim that the derogation procedure for CMR substances in category 1A and 1B is practically 
non-functional. Industry requests for derogations have been consistently rejected, even in cases 

72  
73  

https://webgate.ec.europa.eu/single-market-compliance-space/market-surveillance  
55 authorities were taken into account for this calculation including state and provincial authorities in federal 
states. Calculation: 10 days x 8 hours = 80 hours x 55 competent authorities = 4.400 hours x 29.40 = €129 360  

Page 50 of 109 

 
 
 
 
where the substances were assessed by the SCCS and deemed safe for use in cosmetic products, 
due to the difficulty to prove that the other criteria (compliance with food safety and lack of suitable 
alternatives) have been met. Hence, the strong calls for the exemption procedures to be made more 
transparent, timely, and workable for economic operators especially SMEs. 

The cosmetic industry is increasingly concerned about its future due to the following reasons: 

•  The  growing  number  and  accelerated  pace  of  chemical  classifications  under  the  CLP 
Regulation require reformulations. In many cases, this leads to discontinuation of products 
-including  iconic  ones-  that  cannot  be  reformulated  or  would  suffer  significant 
compromises in performance; 

•  Reformulations triggered by Article 15 prohibitions (i.e., forced reformulations) are often 
atypical and highly complex, as they involve key ingredients central to the function and 
identity of cosmetic products. These reformulations require lengthy innovation processes, 
diverting both financial and human resources away from genuine innovation and towards 
regulatory compliance; 

•  One-to-one ingredient substitution is rarely feasible, as it is highly technically complex, 

resource-demanding and has yielded only limited success to date; 

•  The  unique  combination  of  performance,  safety,  sensory  experience  and  regulatory 
requirements  in  cosmetics  makes  the  identification  of  suitable  alternatives  extremely 
challenging in the short term.; 

•  Reformulation  of  products  is  an  inherent  part  of  the  cosmetic  industry’s  continuous 
innovation  cycle.  It  follows  established  timelines  and  milestones  aligned  to  product’ 
lifecycles  and  business  models.  ‘Forced  reformulations’  interfere  and  disrupt  these 
processes, causing delays and resource reallocation that hinder innovation.  

•  SMEs  are  disproportionately  affected,  lacking  the  capacity  to  develop  complex 
alternatives. Larger companies, meanwhile, face significant challenges due to the scale of 
their operations and complexity of global supply chains. 

Industry  stakeholders  stress  that  adequate  transition  periods  are  essential.  These  would  enable 
regulatory-driven reformulations to be integrated into industry’s natural innovation/reformulation 
cycles.  Transitional  periods  would  also  provide  the  necessary  time  to  reformulate,  relabel  and 
adequately manage existing stocks -thereby preventing market withdrawals and the destruction of 
safe, unsold products.  

Example 1: Lilial (BMHCA) 

Lilial  is  a  widely  used  ingredient  in  the  cosmetic  sector.  After  its  classification  as  a  CMR 
substance,  it  was  banned  from  the  use  in  cosmetic  products  via  the  Omnibus  Act  IV  which 
amended  Annex  II  to  the  CPR.  The  ban  applied  3,5  months  after  the  publication  of  this 
Regulation. 

Page 51 of 109 

 
 
 
 
 
 
 
Data  provided  by  several  cosmetics  companies  indicate  that  the  prohibition  of  Lilial  under 
Article  15  of  the  CPR  resulted  in  substantial  direct  costs  –  including  reformulation,  product 
withdrawal,  and  administrative  burden  such  as  reporting.  For  large  international  companies, 
these costs ranged from €5 320 000 to €53 500 000 (one-off cost per company). Large national 
companies reported reformulation costs between €2 000 000 and €23 000 000, while medium-
sized companies estimated costs between € 600 000 and €8 000 000. 

Apart from the reformulation costs, companies also have to conduct ‘Product-in-Use’ (PIU) tests 
to ensure consumer acceptance and maintain product ‘likeability’. With average PIU test costs 
of approximately €80 000 per product, one large national company estimated the total cost of 
the Lilial phase-out to be around €30 000 000. 

Example 2: Zinc Pyrithione (ZnPt) 

Zinc Pyrithione, a widely used anti-dandruff ingredient, had a long-standing history of safe use 
in  cosmetic products  prior to  its classification as CMR category 1B substance. Following its 
classification, industry submitted a derogation request under Article 15(2) of the CPR, providing 
data to demonstrate its safety in cosmetic products, its compliance with food safety legislation, 
and the lack of suitable alternatives on the market.  

 The  SCCS  subsequently  confirmed  the  safety  of  ZnPt  when  used  in  shampoos  and  its 
compliance with food safety legislation was acknowledged by the Cosmetic Products Working 
Group.  However,  the  European  Commission  and  Member  States  concluded  that  alternatives 
were available, citing  the presence of antidandruff shampoos on the market  using alternative 
ingredients.  

Industry argued that, at the time, these alternatives were not available in sufficient quantities. 
Scaling up product required significant investment and adaptation of manufacturing sites, due 
to the physical hazards - such as explosiveness - associated with the alternative substance. As 
such, industry requested a temporary exemption, or a ban accompanied by an adequate transition 
period  to  allow  sufficient  availability  of  the  alternative.  However,  this  flexibility  was  not 
permissible under Art. 15(2). 

The consequences of the ban were significant. One large international company reported that 
the  impact  represented  18%  of  its  yearly  turnover  (one-off  cost)  generated  from  cosmetic 
products. A large national company estimated a 5-6% reduction in its annual turnover. 

Both  international  and  national  companies  stressed  that  the  ban  severely  affected  their 
competitiveness on the global market. Particularly compared to non-EU companies that continue 
to use Zinc Pyrithione in their products available outside the EU. 

Page 52 of 109 

 
 
 
 
 
 
 
Currently, approximately 10 fragrance ingredients are undergoing harmonised classification and 
labelling (CLH) evaluation, with proposals or conclusions identifying them as CMR category 1B 
substances.  Once  officially  classified,  these  ingredients  would  trigger  the  need  to  reformulate 
around 85% of the 500 000 cosmetic products currently on the market within the next 2-3 years.  
The estimated average cost of reformulating a single cosmetic product is approximately €15 000 
covering  the  costs  of  laboratory  testing,  machinery  adjustments/equipment  and  quality  control. 
Based on this estimate, the reclassification of just these 10 fragrance ingredients would require the 
reformulation of approximately 425 000 products, resulting in a total cost of €6 750 000 000 for 
the cosmetics industry. 

The  average  cost  of  re-labelling  and  re-packaging  follow  the  reformulation  as  the  change  in 
ingredients must be reflected on the package. For medium companies, the packaging cost varies 
from  1%  to  3%  of  the  total  company  turnover.  A  medium  size  company  reported  that  the 
estimated impact of recent regulatory changes requiring allergen labelling would reach between 
€2 000 000 and 5 000 000 (one-off cost for one company). These costs include the recruitment of 
personnel managing the relabelling (equivalent to 5 FTEs), changes in production nomenclatures, 
revision of ingredient list, production and distribution of products with new labels and withdrawal 
of products with old, non-compliant labels. 

The costs of product withdrawals and destruction ranges from 0.5 % to 3 % of a company’s annual 
turnover. 

3.  Issues  and  proposed  amendments  to  Regulation  (EU)  2019/1009  on  EU  Fertilising 

Products (FPR) 

The  Fertilising  Products  Regulation  has  been  applicable  since  2022  only.  Nevertheless, 
stakeholders have identified several issues and shortcomings in the Regulation’s implementation 
which they brought to the Commission’s attention, in bilateral exchanges and in the Commission 
Expert Group for fertilising products. The responsible Commission services have also themselves 
experienced certain obstacles and inefficiencies in procedures mandated by the Regulation, which 
create bottlenecks for the use of certain materials in EU fertilising products. With a view to gather 
additional  feedback  on  the  identified  issues  and  to  give  stakeholders  the  opportunity  to  make 
further  suggestions  for  simplification  of  the  FPR,  a  Reality  Check  for  the  Fertilising  Products 
Regulation was held on 7 May 2025. The following issues and potential solutions were identified 
and discussed with stakeholders. 

a.  REACH registration of substances in EU fertilising products 

Chemical substances, on their own or in mixtures, if manufactured or imported in quantities above 
one tonne per company per year, need to be registered in accordance with Regulation (EC) No 
1907/2006  of the Parliament and of the Council3 (REACH). Information requirements  increase 
with the quantity in which the substance is manufactured or imported per year, with the following 
ranges: 1-10 tonnes per year, 10-100 tonnes per year, 100-1000 tonnes per year and 1000 tonnes 
or more per year. Substances manufactured or imported below one tonne per year do not need to 

Page 53 of 109 

 
 
 
 
 
be  registered. A  chemical  safety  report  (CSR)  is  only  required  for  substances  manufactured  or 
imported  above  10  tonnes  per  year  and  not  for  substances  present  in  a  mixture  in  very  low 
concentrations (below 0.1%). For substances meeting the criteria for classification as hazardous in 
accordance with  the CLP Regulation  or that are assessed to  be persistent, bioaccumulative and 
toxic or very persistent and very bioaccumulative, the CSR has to include an exposure assessment. 

For substances74 used in EU fertilising products, on their own or in mixtures, the FPR does not 
apply  the  gradations  of  information  requirements  under  REACH,  but  requires  more  extensive 
information. It requires that those substances, regardless of their concentration in the EU fertilising 
products and of the quantity in which they are manufactured or imported in the EU, have been 
registered, as a minimum: 

•  with the information requirements set out by Regulation (EC) No 1907/2006 for substances 
manufactured or imported in quantities of 10 to 100 tonnes per company per year or higher; 
and 

•  a  CSR  covering  their  use  in  a  fertilising  product,  in  accordance  with Article  14  of  that 

Regulation. 

Moreover, not all exemptions from the registration requirement that exist under REACH apply 
under the FPR75. 

As explained in recital 26 of the Regulation, the rationale for this extended REACH registration 
requirement  was  to  ensure  that  the  safety  of  the  intended  use  of  the  EU  fertilising  product  is 
demonstrated  in  a  manner  comparable  to  that  achieved  through  other  regulatory  regimes  for 
products  intended  for  use  on  arable  soil  or  crops,  notably  Member  States’  national  fertiliser 
legislation and Regulation (EC) No 1107/2009 on plant protection products76. However, the Impact 
Assessment  for  the  FPR  did  not  assess  this  horizontal  requirement  for  all  substances  in  EU 
fertilising  products77.  Instead  it  analysed  the  impact  of  the  extended  REACH  registration 
requirement  for  chemical  plant  biostimulants,  as  a  counterbalance  to  their  exclusion  from 
Regulation (EC) No 1107/2009 on plant protection products, which provides for very extensive 
data requirements, to fall under the scope of FPR.  

Stakeholder views 
Already in 2022, an industry stakeholder approached the Commission to express its concerns about 
the  extended  REACH  registration  requirement  under  the  FPR,  pointing  to  the  high  costs  of 
REACH  registration  under  these  conditions  and  related  price  increases  for  substances  and  end 
products,  as  well  as  to  the  lower  requirements  in  competing  markets.  Market  distortion  and 

74  

75  

76  

77  

Virgin  substances  under  Component  Material  Category  1  and  additives  or  other  substances  under  other 
Component Material Categories. 
Only the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or 
by points 6, 7, 8, 9 or 10 (only for magnesia) of Annex V to that Regulation apply to substances used in EU 
fertilising products. 
Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning 
the  placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 
91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).  
SWD(2016) 64 final. 

Page 54 of 109 

 
 
 
 
impeded innovation were cited as consequences. In 2023, the topic was discussed in a workshop 
organised by  an industry organisation, where  similar concerns were  raised. Stakeholders  in  the 
Reality Check confirmed that this requirement poses significant obstacles for manufacturers of EU 
fertilising products in using certain substances.  

Stakeholders generally explained that most substances used in EU fertilising products below 10 
tonnes per year are manufactured by upstream suppliers. Therefore, the registration obligation first 
applies to these upstream suppliers. Manufacturers of EU fertilising products often do not know 
whether a substance that they would like to use is registered in accordance with the additional FPR 
requirements. Where they know that this is not the case, they have little leverage to persuade their 
supplier  to  upgrade  the  registration,  unless  the  use  in  EU  fertilising  products  represents  the 
majority of the market. Moreover, to protect confidential business information, suppliers are often 
unwilling to disclose data to the manufacturers of EU fertilising products, preventing those from 
upgrading the REACH registration themselves. Finally, according to business associations, some 
producers or importers of substances  produced in  low quantities,  especially small  and medium 
enterprises (SMEs), can simply not afford REACH registration in accordance with the additional 
FPR requirements. 

As consequences, manufacturers cannot use certain substances in EU fertilising products. They 
alternatively  market  their  products  under  national  rules  for  national  fertilising  products  or  stop 
supplying  the  EU  market  and  turn  to  other  markets,  such  as  the  US.  In  the  above-mentioned 
workshop in 2023, results from a survey among 18 members of the industry association showed 
that more than half of respondents were marketing their products under national rules because of 
the  onerous  registration  requirements  under  the  FPR.  Some  manufacturers  also  replace  the 
substance in question by already registered but underperforming substances. Such reformulation, 
as explained by a company in the Reality Check, implies costly reformulation tests, stability tests 
and greenhouse tests. It can also result in lower product quality, for instance when removal of an 
anticaking agent leads to lumping of the product78. 

The problem was reported to be particularly relevant for technical additives, like dyes, which are 
mostly used in very small quantities and are difficult to substitute as performance varies a lot from 
one additive to another. In the 2023 workshop, it was reported, based on the survey results, that 
90% of manufacturers were using technical additives that were only registered at the 1-10 tonnes 
band,  and  hence  not  eligible  for  use  in  an  EU  fertilising  product.  Moreover,  nearly  all  of  the 
respondents  said  that  most  or  some  of  their  technical  additives  are  mixtures  with  unknown 
composition, making it impossible for them to verify the different substances’ registration status. 
But the problem does not only concern additives. Some primary components of fertilising products 
are  also  produced  and  used  in  small  amounts  and  therefore  affected  by  this  extended  REACH 
registration requirement. 

Several stakeholders in the Reality Check considered that the more extensive REACH registration 
should  be  maintained  at  least  for  certain  substances,  such  as  very  hazardous  substances,  like 
persistent, bioaccumulative and toxic ones, and/or for certain unknown, bio-active substances, also 

78  

Example presented at the 2023 workshop. 

Page 55 of 109 

 
 
 
 
considering the specific use pattern of fertilising products, namely their direct, continued and often 
large-scale application in the environment. 

Proposed amendments and next steps  
Taking  into  account  the  concerns  described  above,  and  in  light  of  the  extensive  safety  and 
information requirements under REACH for all substances manufactured and used in the EU and 
the safety requirements under the FPR, the extended REACH registration requirement under the 
FPR seems to pose a disproportionate burden.  

Therefore, it is proposed to delete the requirement to register substances in EU fertilising products 
in  accordance  with  the  requirements  outlined  above  from  the  FPR.  In  absence  of  any  specific 
requirements  under the  FPR, the general REACH provisions, including  the relevant  gradations 
depending on quantity, would apply to substances used in EU fertilising products. The safety of 
EU fertilising products would still be ensured for the following reasons:  

a)  under REACH, manufacturers, importers and downstream users are obliged to ensure that 
they only  manufacture,  place on the market  or use substances that do not  affect  human 
health or the environment; 

b)  where Member States or the Commission have a concern about a certain substance used in 
fertilising products which should be addressed on an EU-wide basis, they should prepare a 
restriction dossier in accordance with Article 69 of REACH. If the concern is well-founded, 
the substance can be banned for the use in  fertilising  products,  including  EU fertilising 
products,  under  REACH.  The  Commission  has  initiated  such  assessment  for  calcium 
cyanamide79;  

c)  it is expected that, without the extended REACH registration requirement, more companies 
will start to market their products as EU fertilising product. Having access to the Internal 
Market, they will likely go into larger-scale production. From that point on, the quantities 
of most substances used in EU fertilising products will trigger registration at the 10-100 
tonnes  band,  i.e.  the  information  currently  required  under  the  extended  REACH 
registration requirement will in most cases be available also in the future;  

d)  under the FPR, manufacturers are obliged to carry out an analysis and assessment of risks 
and may not place on the market a product that presents a risk to human, animal or plant 
health, regardless of whether the risk results from no-compliance or aspects not covered by 
the FPR. The FPR's safety requirements can be amended by the Commission on the basis 
of  new  scientific  evidence,  such  as  new  information  about  harmful  substances  or 
contaminants; 

e)  with more fertilising products being marketed as EU fertilising products, more fertilising 
products on the Internal Market will comply with the FPR rules, which are more stringent 
than many national rules; 

79  

https://echa.europa.eu/registry-of-restriction-intentions/-/dislist/details/0b0236e1824484f8. 

Page 56 of 109 

 
 
 
 
f)  food safety is further ensured by other EU legislation, notably Regulation (EU) 2023/915 
on maximum levels for certain contaminants in food80 and Regulation (EC) No 396/2005 
on maximum residue levels of pesticides in or on food and feed of plant and animal origin81. 

The amendment concerns Annex II, Part II, CMC 1, point 2, CMC 3, point 1(d), CMC 4, point 
1(b) and 3d, CMC 5, point 1(d) and 3d, CMC 6, point 2, CMC 8, point 1, CMC 10, point 1.3, CMC 
11, point 2, CMC 12, point 13, CMC 13, point 8, CMC 14, point 7, and CMC 15, point 10. 

Estimated cost savings 
When considering the cost saving from applying standard REACH registration requirements to 
substances used in EU fertilising products, costs for different actors in the supply chain need to be 
considered:  the  manufacturer/importer  of  the  substance,  the  manufacturer  of  the  EU  fertilising 
product and the user of the EU fertilising product. 

For  substances  below  1t/y,  the  extended  REACH  registration  requirement  in  the  FPR  creates 
substantial new costs compared to the absence of a registration obligation under REACH, while 
for substances between 1t and 10t/y, as explained by a company, the registration costs are about 
65% higher for substances used in EU fertilising products. 

Companies  registering  a  substance  under  REACH  are  required  to  pay  a  fee  to  the  European 
Chemicals Agency (ECHA). For substances in the range 10 to 100 tonnes, the currently applicable 
fee  is  €4 674  for  individual  submission  for  new  registrations.  For  SMEs,  reduced  fees  apply, 
ranging from €234 for micro enterprises to €3 038 for medium enterprises. The standard fee for 
updating  a  registration  dossier  from  the  1-10  tonnes  range  to  the  10-100  tonnes  range,  for 
individual submissions, amount to €2 935. For SMEs fees range from €147 to €1 908 In case of 
joint submissions, the fee to be paid by each registrant is lower82. Currently, 154 substances are 
registered for agricultural use under REACH, but do not meet the FPR’s extended requirements 
(see Annex V). Assuming a share of those substances between SMEs and large companies in the 
fertilising products sector as estimated in the Impact Assessment for the FPR83, industry would 
have to pay fees of about €187 586 if those registration dossiers were to be updated to comply with 
the FPR via individual submissions.84 

Although  SMEs  benefit from  reduced  registration  fees,  they  also  incur  costs  for  proving  SME 
status, as explained by a company in the Reality Check. Moreover, the fees represent less than 5% 

80  

81  

82  

83  
84  

119, 

(OJ  L 

1881/2006 

(EC)  No 

05/05/2023, 

Regulation  (EU)  2023/915  of  25 April  2023  on  maximum  levels  for  certain  contaminants  in  food  and 
repealing  Regulation 
103,  ELI: 
http://data.europa.eu/eli/reg/2023/915/oj). 
Regulation  (EC)  No  396/2005  of  the  European  Parliament  and  of  the  Council  of  23  February  2005  on 
maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council 
Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1, ELI: http://data.europa.eu/eli/reg/2005/396/oj). 
Commission (EC) No 340/2008 of 16 April 2008 on the fees and charges payable to the European Chemicals 
Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the 
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ L 107, 17.4.2008, p. 6, 
ELI: http://data.europa.eu/eli/reg/2008/340/oj).  
SWD(2016) 64 final. 
As no data on the shares of medium, small and micro enterprises within the SME category was available, the 
figure was calculated assuming equal shares for each enterprise size. 

p. 

Page 57 of 109 

 
 
 
 
of  total  registration  costs,  whereas  the  bulk  of  costs,  i.e.  for  the  preparation  of  the  dossier  and 
testing, is the same for large companies and SMEs. 

In a study carried out for the Commission in 202185, based on results from a survey among industry, 
the average overall costs per registration, per company, for 10-100 t/y substances, including fees, 
dossier preparation and testing, was estimated at around €101 000 per registrant and €280 000 per 
substance, although, depending on the testing required for the substance concerned, costs may be 
much higher. The costs of preparing a registration dossier (including drafting, finalising a technical 
registration dossier and submitting it, including administrative data and producing summaries for 
REACH  annexes)  at  this  tonnage  band  was  estimated  at  €39 000.  The  average  cost  for 
physicochemical, toxicological and ecotoxicological tests for 10-100t/y substances was estimated 
at  €144 329  per  substance.86  In  addition,  the  costs  for  a  chemical  assessment/report  were  on 
average € 14 801. The average costs for updates of registration dossiers were not assessed.87 In the 
Impact Assessment for the FPR, overall costs for industry to comply with the extended REACH 
registration  requirement  were  not  assessed.  Only  the  costs  for  the  registration  of  plant 
biostimulants were calculated, but only for the 1-10 tonnes band. The costs for compiling data and 
the fees together were initially estimated at €131 714 per substance88. 

In the context of the Reality Check, stakeholders reported costs for complying with the extended 
REACH registration requirement of up to €500 000 per substance. An industry association shared 
results from a survey carried out among their members asking about the burden of the extended 
REACH registration requirement under the FPR. Depending on the tonnage band and the extent 
of data required, the costs reported in the survey for upgrading a registration dossier in accordance 
with the FPR vary between €10 000 to €500 000 per substance. Across the evidence received, 
€180 000 was found as the typical investment needed to upgrade a registration dossier from 1-
10t/y to the 10-100t/y requirements. A company contributing to the Reality Check reported costs 
in  a  similar  range.  For  the  six  substances  that  the  company  registered  in  accordance  with  the 
extended  requirements  under  the  FPR,  it  spent  between  €100 000  and  €500 000,  including  the 
costs for data generation, consultancy, dossier preparation and the fees paid to ECHA. In the same 
vein, an industry association estimated that costs for upgrading a registration from the 1-10 tonnes 
to  10-100  tonnes  band,  excluding  the  fees,  can  result  in  costs  of  up  to  €400 000,  and  another 
industry association reported that, depending on the substance and its registration status (upgrading 
from the 1–10 t/year band to 10–100 t/year or registering an exempt substance in the >10 t/year 
band), costs range between €150 000 and €240 000. Costs in this range were also confirmed by a 
Member State authority, estimating total registration costs of €270 000 for a substance produced 
below one tonne per year. All those figures from stakeholders and the cost estimates from the study 
mentioned above roughly  concur. Overall, it can be assumed that costs for complying  with the 
extended REACH registration dossier range from €10 000 (for substances already registered, with 
little additional data to be generated for the upgrade) to €500 000 (for substances not yet registered 

85  
86  

87  
88  

Wood, Study on the impacts of the 2018 REACH registration deadline. Final Report, 2021. 
Physiochemical  requirement  study  costs:  €13 125,  toxicological  requirement  study  costs:  €104 911, 
ecotoxicological requirement study costs €26 293. 
Wood, Study on the impacts of the 2018 REACH registration deadline. Final Report, 2021, pp. 53, 122, 123. 
SWD(2016) 64 final, see table 47. 

Page 58 of 109 

 
 
 
 
or registered for 1-10t, with a significant amount of additional data to be generated). €180 000 can 
be considered the average cost for complying with the requirement. 

On this basis, it is estimated that a one-off cost of about €19 220 000 (see Annex IV) would occur 
to  update  REACH  dossiers  (data  generation,  dossier  preparation  and  fees  to  ECHA)  for  all 
substances registered with possible value in fertilising products and a tonnage band of less than 
10t/y, let alone the substances not registered under REACH because they are currently placed on 
the market in volumes below 1t/y. 

According to a position paper signed by several industry associations, the costs for the extended 
REACH  registration  eventually  leads  to  increased  costs  for  manufacturers  of  EU  fertilising 
products and materialises in increased prices for users. Using several examples, they calculated 
that the cost of the extended REACH registration, if spread over a period of five years, would lead 
to an increase of the cost of the substance by 40%-540%, depending on the volume in which it 
is manufactured or imported and the concentration in which it is used in the fertilising product. 
This was confirmed in position papers of another industry association and a competent authority. 
The price of the end product would then also have to be increased. For an EU fertilising product 
using a substance below in the <1t range, the estimated price increase would be by 26%. 

By  removing  the  extended  REACH  registration  requirement  from  the  FPR,  normal  REACH 
requirements would apply to substances used in EU fertilising products, even if manufactured in 
low quantities. This would allow more substances to be used in EU fertilising products, as many 
of them might be exempt from the registration requirement or already registered for the 1-10 t/y 
band.  It  would  thereby  avoid  the  costs  of  (updating)  registration  at  the  10-100  t/y  band  for 
substances  used  in  low  quantities  that  are  difficult  to  substitute,  thereby  reducing  the  cost  of 
reformulation. This would remove a technical barrier and increase the added value of EU fertilising 
products compared to national ones, which are already subject to the ‘standard’ REACH provisions 
only. 

Manufacturers which would CE-mark their products to place them on the single market, would no 
longer face multiple fees for national registrations (between €0 and €50 000 per product per MS) 
and costs to adapt their products, labels or packaging to meet different rules between two or more 
national rules (reported adaptation costs between two sets of national rules between €15 000 and 
€43 000).89 

b.  Assessment of microorganisms in plant biostimulants 

Micro-organisms are an important area for innovation in fertilising products. They can be used in 
plant biostimulants which stimulate plant nutrition processes and, thereby, allow for a reduced use 
of fertilisers. However, currently, only four groups of micro-organisms may be used as component 
material (CMC 7) in EU fertilising products: Azotobacter spp., Mycorrhizal fungi, Rhizobium spp. 
and Azospirillum spp. The Commission is empowered to add new micro-organisms or strains of 
micro-organisms to the positive list after having assessed the safety and agronomic efficiency of 

89  

Impact Assessment accompanying the Proposal for a Fertilising Product Regulation, SWD(2016) 64 final. 

Page 59 of 109 

 
 
 
 
each strain. For such assessment, the Commission depends on the support of external contractors 
and is constraint by the available budget that can be spent on such external studies. 

Since the entry into force of the FPR, no additional micro-organisms or strains of micro-organisms 
were added to the positive list. A study carried out for the Commission by the Austrian Institute 
for Technology is currently assessing 34 strains for potential inclusion. The study was launched 
end of 2023, and it will run for a period of 24 months. Based on the outcome of the study, the 
Commission will prepare a delegated act to add those strains that meet the safety and efficiency 
requirements of the FPR to the positive list. The adoption process will take at least six months. 

In the meantime, new strains of micro-organisms for potential use in EU fertilising products, which 
are not covered by the study are discovered by industry. If and when those might be added to the 
positive list is uncertain. The current mechanism for adding  new micro-organisms or strains of 
micro-organisms is thus creating a bottleneck for the placing on the market of plant biostimulants 
in the EU. 

Stakeholder views 
Microbial  biostimulants,  based  on  a  variety  of  micro-organisms,  bring  several  benefits  for 
farmers  and  the  environment. According  to  stakeholders  participating  in  the  Reality  Check, 
those include: 

•  Enhancement  of  Nutrition  Use  Efficiency  (NUE)  and  function  as  nitrogen-fixing, 

phosphorus-solubilizing, and potassium-mobilising agents; 
Increasing the crops’ tolerance to abiotic stress; 
Improvement of water absorption (mycorrhizal fungi); 

• 
• 
•  Reduction of water contamination by nutrients and greenhouse gas emissions; 
•  Minimisation of soil degradation, promotion of microbial biodiversity in agricultural soils, 

and contribution to CO₂ capture from the atmosphere. 

The mechanism for allowing the use of additional micro-organisms or strains of micro-organisms 
in EU fertilising products under the FPR, presupposing a one-by-one strain-level assessment by 
the Commission, has been criticised by stakeholders as being incompatible with the need and 
the  pace  of  development  of  the  growing  plant  biostimulant  sector,  and  discussions  about  a 
potential simplification of the procedure started already in 202190. The process is considered to 
slow  down  market  access  for  microbial  plant  biostimulants,  discourage  innovation  and 
investments, and delay the availability of these products to farmers. 

Industry associations underlined in the context of the Reality Check that, as a consequence of not 
being able to market their biostimulants under EU rules, manufacturers market their product under 
national rules of the Member States. This is a significant burden, especially for SMEs, due to 
the large variations of Member States’ rules, the need to seek approval in different jurisdictions 

90  

At  the  Expert  Group  meeting  of  22-23  November  2021,  several  options  were  discussed.  Stakeholders 
submitted  position  papers  with  their  preferred  solutions.  The  relevant  documents  are  accessible  on 
CIRCABC. At the Expert Group meeting of 26-27 November 2024, it was again on the agenda, based on a 
proposal by the Forum of Notified Bodies, see CIRCABC. 

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and  the  well-known  issue  with  mutual  recognition  of  authorisations  for  fertilising  products. 
Moreover, EU manufacturers might seek alternative markets outside the EU. Finally, given the 
unfavourable  conditions  in  the  EU,  innovation  and  investment  of  such products  might  take 
place in third countries. 

In  a  survey  carried  out  by  an  industry  association  in  the  plant  biostimulant  sector  among  65 
members,  88%  of  participants  said  that  they  were  not  able  to  place  their  microbial  plant 
biostimulant on the EU market because the micro-organism used was not yet on the positive list. 
Most  respondents  placed  microbial  plant  biostimulants  on  the  market  via  national  rules,  with 
approval times ranging from 6 months to 3 years and costs between €5 000 to €30 000. 59% of 
respondents are currently exporting microbial  plant biostimulants to third countries, incl. 
the United States, Argentina, Mexico and Brazil, which means that their products manufactured in 
the EU, and often developed using EU research funding, are not provided to EU farmers. 72% of 
respondents said that they have several products which would be ready to go through the FPR’s 
conformity assessment within two years, if the micro-organisms used therein was allowed under 
CMC 7. An industry association shared in the Reality Check that, in Spain alone, sales of micro-
organism-based fertilising product from associated companies exceed €30 million, underlining the 
potential of these products also for the internal market. 

The above-mentioned study is developing a methodology and general criteria for the assessment 
of strains of micro-organisms which could be used as a basis for a future amendment of CMC 7 in 
exercise of the Commission’s new empowerment. Many stakeholders participating in the Reality 
Check were in favour of the criteria-based approach and of using the methodology developed in 
that study as basis for the amendment to CMC 7. Some written contributions pointed to certain 
weaknesses of the current draft methodology. A few stakeholders underlined the importance of a 
thorough safety assessment and of providing for the possibility of a reassessment on the basis of 
new information, and some suggested that the assessment should not be left to manufacturers and 
notified bodies but be carried out by an independent body, like the European Food Safety Agency 
(EFSA). One stakeholder emphasised the importance of ensuring the protection of confidential 
business information within the new criteria-based mechanism. 

Proposed amendments and next steps 
Based  on  the  feedback  received,  it  is  proposed  to  provide  the  Commission  with  a  new 
empowerment in Article 42 FPR to amend Annex II, Part II, CMC 7, to set out general safety and 
agronomic efficiency criteria for micro-organisms and a methodology which manufacturers should 
use to assess and demonstrate compliance with those criteria and by notified bodies to confirm this 
assessment. This approach would be to some extent similar to what has been agreed by the co-
legislators for the assessment of risks associated to the use of microbial detergents in the revised 
Regulation on detergents and surfactants91. It should be noted however, that, in the risk assessment 
of microbial  detergents,  there is no  involvement  of notified  bodies and manufacturers are self-
certifying the safety of the products.  

91  

Council  and  Parliament  strike  a  deal  to  make  detergents  safer  for  the  population  and  the  environment  - 
Consilium. 

Page 61 of 109 

 
 
 
 
The criteria and methodology developed in the ongoing study could be used as a basis for a future 
amendment of CMC 7 in exercise of the Commission’s new empowerment. The Commission will 
make sure that the criteria and methodology that will eventually be introduced allow for a thorough 
verification that a strain of a micro-organism does not present a risk to human, animal or plant 
health, to safety or to the environment, and that it ensures agronomic efficiency. Trusting that only 
qualified  and  reliable  conformity  assessment  bodies  are  notified  by  Member  States’  notifying 
authorities, the new mechanism will provide an assessment of, at least, the same quality as under 
the current empowerment. 

The current empowerment for the addition of new micro-organisms or strains of micro-organisms 
to the positive list would be maintained. This would allow the Commission to include the strains 
currently being assessed and, potentially, further strains in the future. Manufacturers and notified 
bodies  would  not  need  to  assess  those  strains  included  in  the  positive  list  against  the  general 
criteria. 

Estimated cost savings 
The introduction of the new empowerment as such will not entail any cost savings. However, once 
the Commission has made use of the empowerment, economic benefits in terms of incentives for 
innovation, faster market access, enhanced competitiveness and increased availability of products 
are expected for various actors: 

•  Manufacturers  of  plant  biostimulants:  Although  manufacturers  and  importers  of  EU 
plant biostimulants might incur some additional cost in the conformity assessment of their 
product  to  cover  the  assessment  of  the  micro-organism,  these  costs  are  expected  to  be 
negligeable  compared  to  the  economic  benefit  of  having  free  access  to  the  internal 
market92.  Costs  currently  incurred  for  familiarising  and  complying  with  the  different 
national rules for microbial plant biostimulants could be avoided by complying with the 
harmonised rules under the FPR. It is estimated that regulatory cost to access the single 
market  instead  of  multiple  national  markets  would  be  significantly  reduced93. 
Allowing  industry  and  notified  bodies  to  perform  the  safety  and  efficiency  assessments 
would also speed up the access to the market, considering that national authorisations 
can take more than 18 months. 

•  Farmers: It is expected that the new mechanism for the assessment of micro-organisms 
would increase the availability of microbial plant biostimulants on the EU market. Farmers 
would  benefit  from  a  larger  choice  of  products  that  they  can  use  to  improve  the  plant 

92 

93 

In the context of the Reality Check, no costs were brought forward as an argument  against this proposed 
amendment. 
As explained in the context of the extended REACH registration requirement, manufacturers which would 
CE-mark their products to place them on the single market, would no longer face multiple fees for national 
registrations (up to €50 000 per product per MS) and costs to adapt their products, labels or packaging to 
meet  different  rules  between  two  or  more  national  rules  (reported  adaptation  costs  between  two  sets  of 
national rules between €15 000 and €47 000), see tables 13 and 14 in SWD(2016) 64 final. In order to place 
a fertilising product according to national rules in 5 Member States, a company could face administrative 
costs of at least €60 000. Assuming €3 900 for a certification by a notified body under module B+C for 10 
years (see table 40 in SWD(2016)64 final). 

Page 62 of 109 

 
 
 
 
nutrition processes of their crop. As a result, they might be able to reduce the volume of 
fertilisers  used.  Studies  have  shown  that  by  applying  certain  microbial  plant 
biostimulants, the fertilisation could be reduced between 33% and 80%, depending on 
the product and the overall treatment of the crop, without any negative effect on the yield.94 
In consequence, fertilisation costs for farmers can be reduced and the autonomy of the EU 
for fertilising products be improved. 

•  Notified bodies: Notified bodies will need to update their accreditation and notification to 
cover the assessment of micro-organisms in accordance with the criteria and methodology 
set out by the Commission. However, they will likely benefit from an increased number of 
applications for conformity assessment for microbial plant biostimulants. 

•  European Commission: The  cost  for the assessment of micro-organisms would, in  the 
future, be born by industry. In consequence, costs for external  studies, which are in  the 
lower 6-digit range per study, would be saved and could be invested elsewhere.95 

c.  Digitalisation 

Under  the  FPR,  certain  provisions  seem  to  not  fully  enable  the  use  of  new  technologies  and 
digitalisation of procedures. Due to the FPR’s specificities, including the rules on voluntary digital 
labelling, it was not included in the Proposal for a Regulation of the European Parliament and of 
the  Council  amending  Regulations  [...]  as  regards  digitalisation  and  common  specifications 
(Omnibus IV)96. 

One example is the contact information that economic operators are required to provide on the 
product. Currently, the name, trade name or trademark and postal address need to be indicated, 
while the indication of a digital contact, such as an e-mail address, is only voluntary. Moreover, 
economic  operators  are  required  to  provide  competent  authorities,  upon  request,  with  all  the 
information  and  documentation  necessary  to  demonstrate  the  conformity  of  an  EU  fertilising 
product. This  can  be  done  either  in  electronic  or  in  paper  form. As  it  is  not  specified  whether 
documents drawn up in the context of the conformity assessment, either by notified bodies or by 
manufacturers, should be in paper or electronic format, some might currently only be available in 
paper. The EU declaration of conformity, currently, does not need to accompany the EU fertilising 
products,  but  must  be  made  available  to  the  relevant  authorities  or  economic  operators  upon 
request. The format in which it shall be provided is not further specified. 

As outlined in the Staff Working Document accompanying Omnibus IV, Member States and their 
various  market  surveillance  authorities  have  divergent  views  and  practices,  some  requiring 
documents in paper format while others accept digital transmission of documents97. Overall, the 

94  

95  

96  
97  

Gazoulis  et  al., A  Preliminary Assessment  of  the  Combined  Effects  of  a  Novel  Microbial  Biostimulant 
Product, Fertilizers, and Herbicides on the Growth and Yield of Field Crops in Greece, Agronomy 14:8, 2024; 
Rossini  et  al,  Combining  nitrogen  fertilization  and  biostimulant  application  in  durum  wheat:  Effects  on 
morphophysiological traits, grain production, and quality, Italian Journal of Agronomy 20:1, 2025. 
To note that there is no recurrent budget for such studies. While one study is ongoing, it is unclear if and 
when the next study could be launched. 
COM(2025)504. 
SWD(2025) 130 final, p. 4. 

Page 63 of 109 

 
 
 
 
existing provisions might lead to a situation where manufacturers, despite the flexibility provided 
by the FPR, draw up documents in paper format, in order to be sure that the documents will be 
accepted by authorities and notified bodies. 

Stakeholder views 
In the targeted consultations for the evaluation of the NLF98, 74.5% of the respondents thought 
that the efficiency of the conformity assessment procedure would largely improve (35 responses) 
due to digitalisation of the declaration of conformity / technical product information / technical 
file, without hindering market surveillance activities, while a further 12.8% (six responses) thought 
it would improve to a moderate extent. The NLF evaluation also found (see p.49) that “[i]ndustry 
respondents were in favour of moving towards digital only CE marking, product compliance and 
user information as soon as possible. This was seen as potentially reducing costs, but only if hard 
copy versions were no longer required. However, none of the national competent authorities shared 
this view.”  

Moreover, in  the context of the preparations of the Omnibus IV, the Commission  organised an 
outreach  event  aiming  at  gathering  the  opinions  and  feedback  of  the  stakeholders  on  the 
simplification  exercise.  In  parallel,  the  Commission  reached  out  directly  to  stakeholders 
representing sectorial industries in order to gather data on potential cost savings that a ‘digital by 
default’ policy could create. In addition, on 14 April 2025, the Commission consulted the members 
of  Task  Force  1  of  the  Industrial  Forum  and  other  stakeholders,  including  representatives  of 
consumer  organizations  to  gather  their  opinions  on  the  digitalisation  of  the  DoC,  digital 
instructions for use and on the introduction of the DPP and its use as a tool for making compliance 
related information accessible. Feedback received in the context of these consultation activities 
showed broad support for the digitalisation initiative from stakeholders99. 

In the context of the Reality Check carried out in preparation of this proposal, several stakeholders, 
including industry and authorities, underlined that the digitalisation of information requirements 
can reduce the administrative burden for companies and authorities, as electronic management can 
facilitate the exchange, storage and access to information, reduce errors associated with manual 
processes, and minimise paper usage and the costs linked to the handling of paper documents.  

Some concerns were expressed in  relation  to  cyber security, availability and interoperability of 
digital infrastructure, costs for acquiring necessary technology and, in relation to exports, paper-
based systems  in third countries. Several  stakeholders pointed out that industry and  authorities 
would need 2-3 years to adjust to the new digital requirements, while one suggested 1-2 years. 

Proposed amendments and next steps  
Aligning the FPR, where appropriate, to the Omnibus IV, this proposal includes amendments to 
Article 2, Articles 6-9, Article 15, Article 16 and Article 41, as well as to Annex I, Part II, and 
Annex IV, Part II, which would implement the following changes to information and reporting 
obligations:  

98  
99  

SWD(2022)364 final/2, p. 34  
SWD(2025) 130 final, pp. 13f. 

Page 64 of 109 

 
 
 
 
•  Specifying that the EU declaration of conformity must be drawn up in electronic form and 

made accessible through an internet address or data carrier; 

•  The addition of a ‘digital contact’ as information to be indicated by economic operators on 
the products which are placed on the market in order to facilitate communication between 
economic  operators  and  national  authorities.  Once  the  European  Business  Wallet  is 
available, the digital address it provides to economic operators could constitute the “digital 
contact”100; 

•  The  amendment  of  reporting  obligations  to  national  authorities  that  require  a  ‘paper  or 

electronic format’ to ‘electronic form’ only; 

•  Specifying that documents  and  exchanges between the economic operators and notified 

bodies related to conformity assessments shall be in electronic form; 

•  An obligation that, if a digital label is used, the same data carrier providing access to the 

digital label should also provide access to the EU declaration of conformity; 

•  An obligation to provide the information contained in the EU declaration of conformity 
and,  if  applicable,  digital  labelling  on  the  digital  product  passport  when  the  product  is 
subject to other Union legislation that requires the use of such a digital product passport. 

In line with the Omnibus IV and the suggestions from stakeholders, the entry into application of 
these amendments should be deferred by 24 months. 

Estimated cost savings 
In the context of the Reality Check, stakeholders confirmed that the further digitalisation would 
entail  cost  savings  but  were  unable  to  quantify  these  savings.  The  Staff  Working  Document 
accompanying the Omnibus IV concluded that the digitalisation of reporting obligations would 
imply the following costs or cost savings: 

•  For businesses: The digitalisation of economic operators’ obligations would facilitate and 
speed  up  the  transmission  of  documents  to  authorities.  The  simplified  document 
management, i.e. no handling of paper copies and no update costs of existing documents, 
would result in cost savings, which, however, could not be quantified. In addition, it was 
estimated that companies can save costs related to paper, printing and postage of about €4 
per year, assuming they are asked to provide these documents to authorities in paper once 
a  year.  For  businesses  that  are  already  providing  all  relevant  information  in  electronic 
format, the amendments would not bring any cost savings. At the same time, companies 
would incur no or only negligeable additional costs, related to the upload of the relevant 
information to a digital storage.  

•  Public  administrations:  Costs  and  cost  savings  for  public  authorities  could  not  be 
quantified. It was acknowledged that they may incur some additional costs for the training 
of staff in working with electronic files and the relevant IT systems. However, they could 

100  

Building  on  the  European  digital  identity  framework,  the  EU  Business  Wallet  will  enable  secure  digital 
identification, 
See 
https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14663-European-Business-Wallet-
digital-identity-secure-data-exchange-and-legal-notifications-for-simple-digital-business_en. 

notifications 

sharing 

legally 

across 

valid 

data 

EU. 

and 

the 

Page 65 of 109 

 
 
 
 
save  costs  related  to  the  handling  of  paper  documents  (opening  letters,  registering  the 
document, filing/storing the physical document) and it was expected that, in the medium- 
to  long-term,  the  digitalisation  of  reporting  obligations  will  increase  public  authorities’ 
efficiency. 

•  Environmental costs and cost savings: Some environmental benefits will be achieved by 
reducing  the  use  of  paper.  It  is  estimated  that  roughly  one  tonne  of  CO2  emissions  are 
associated to the production of one tonne of paper101, with lower values for recycled paper 
and higher values for virgin paper. Although, on the other hand, there will be some negative 
environmental impacts linked to the creation and use of additional digital infrastructure, it 
was expected that “the environmental balance in the medium to long run is favourable for 
replacing paper with digital technology”102. 

d.  Removal of the ‘unbundling clause’ 

The  FPR  empowers  the  Commission  not  only  to  add  additional  micro-organisms  or  strains  of 
micro-organisms  to  CMC  7,  but  also  to  make  other  amendments  to  the  component  material 
categories in Annex II to the Regulation, in order to adapt those Annexes to technical progress or 
to  new  scientific  evidence  and  to  facilitate  internal  market  access  and  free  movement  for 
EU fertilising  products.  However,  according  to Article  43  FPR,  the  Commission  shall  adopt  a 
separate  delegated  act  in  respect  of  each  component  material  category.  In  view  of  the  many 
amendments still to come for the addition of new materials, which will foster the circular economy, 
or for making other adjustments, this ‘unbundling clause’ is a source of significant inefficiencies. 
From the legal drafting, via the consultation of experts and the public, until the adoption procedure 
–  the  entire  procedure  for  adopting  delegated  acts  is  multiplied,  even  if  the  same  or  similar 
amendments are made to all component materials.  

Stakeholder views 
Stakeholders  were  not  directly  consulted  on  this  provision  and  its  proposed  amendment  as  it 
mainly concerns Commission procedures. However, stakeholders frequently complain about the 
slow pace of the adoption of delegated acts under the FPR, which is causing delays in the use of 
certain materials. Moreover, the experts in the Commission Expert Group are consulted on every 
delegated act, and the higher the number of delegated acts proposed, the more time they need to 
spend  on  familiarisation  with  the  draft  and  providing  feedback. Any  amendment  which  might 
speed up the process is therefore expected to be welcomed also by stakeholders.  

Proposed amendments and next steps  
It  is  therefore  proposed  to  delete Article  43  FPR,  in  order  to  enable  the  Commission  to  make 
amendments to several component material categories in one delegated act. 

101  

102  

https://bioresources.cnr.ncsu.edu/resources/life-cycle-carbon-footprint-analysis-of-pulp-and-paper-grades-
in-the-united-states-using-production-line-based-data-and-integration.  
SWD(2025) 130 final, pp. 18-21. 

Page 66 of 109 

 
 
 
 
Estimated cost savings 
This amendment would not directly save costs for industry or authorities, but it would streamline 
the procedure for the adoption of delegated acts, thereby freeing resources and speeding up the 
inclusion of additional materials or other changes in the component material categories.  

e.  Other areas where stakeholders called for simplification 

In the context of the Reality Check, stakeholders made several other suggestions for simplification 
which were not taken on board in this targeted simplification exercise. 

•  Inclusion  of  derived  products  from  animal  by-products  listed  in  Article  2(2)  of 

Regulation (EU) 1069/2009 

Several stakeholders expressed interest in using derived products from animal by-products listed 
in Article  2(2)  of  Regulation  (EU)  1069/2009  (Animal  By-Products  Regulation, ABPR)  in  EU 
fertilising products, in particular shells, fish sludge, mineralised guano and cat litter. In the light of 
the sensitivity of these materials, the Commission will further investigate the possibility and ways 
of adding those materials to the FPR. 

•  Clarifications in the legal text 

An  industry  association  suggested  making  several  clarifications,  currently  addressed  in  the 
Commission’s  FAQ  document103,  in  the  legal  text.  As  the  amendments  proposed  concern 
exclusively the Annexes to the Regulation, they can be made via delegated act and the Commission 
will consider them independently from this proposal. 

•  Moving to a criteria-based approach for derived products from animal by-products 

or for all component material categories 

Several  industry  stakeholders  advocated  for  moving  away  from  an  individual  assessment  of 
materials to be added to the different component material categories (CMCs) to a criteria-based 
approach for all CMCs, or at least for derived products from animal by-products (CMC 10). As 
this would be a substantial departure from the current functioning of the FPR, the Commission 
considers that whether there are shortcomings or inefficiencies in the existing system should first 
be assessed in the ongoing evaluation of the Regulation  

•  Changes to the digital labelling rules 

Some industry stakeholders suggested changes to the rules on digital labelling introduced in 2024, 
including alignment with CLP and extension of information which can be provided in the digital 
label only, without duplication on a physical label104. The labelling rules will be applicable from 1 
May 2027. The Commission considers that there is currently no reason to amend the rules agreed 

103  

104  

https://webgate.ec.europa.eu/circabc-ewpp/d/d/workspace/SpacesStore/148ac2da-00ae-4fa8-8ed0-
270bce690efe/download.  
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).  

Page 67 of 109 

 
 
 
 
upon by the co-legislators in 2024. The Commission will carry out  an evaluation of the digital 
labelling rules by 21 October 2031 and, if appropriate, develop a legislative proposal to adjust the 
provisions105. 

•  Improving coherence with other relevant legislation 

Some industry stakeholders pointed to unclarities or coherence issues between the FPR and other 
relevant legislation, notably the ABPR, REACH and the Waste Framework Directive (Directive 
2008/98/EC)106. As the FPR is assessed for external coherence under the ongoing evaluation, any 
measures in this regard would be premature. 

•  Clarification in relation to impurities 

Several  industry  stakeholders  asked  the  Commission  to  clarify  that  component  materials  may 
contain  detectable  traces  of  impurities  and  unintended  substances  which  are  not  considered 
component materials. The Commission considers that such clarification is not needed as impurities 
and unintended substances are acknowledged in the definition of ‘substance’ under REACH, to 
which the FPR refers in its own definition of ‘substance’. Impurities should not be considered as 
substances on their own, but should be dealt with in the context of the relevant substance they are 
part of in the REACH registration. 

•  Negative list of prohibited compounds 

A Member State authority proposed to establish a negative list of compounds not to be used in 
fertilising  products  similar  to  the  list  in Annex  III  to  Regulation  (EC)  No  1107/2009  on  plant 
protection products107. The Commission considers that considerations of that kind should only be 
made  once  the  results  of  the  ongoing  evaluation  of  the  FPR  are  available.  The  evaluation  is 
assessing whether the FPR’s current provisions are appropriate to ensure a high level of safety and 
environmental protection. 

•  Revision  of  the  Information  and  Communication  System  on  Market  Surveillance 

(ICSMS) 

A Member State authority suggested the revision of the Information and Communication System 
on Market Surveillance (ICSMS) to better account for the specificities of the fertilising products 
sector. The establishment and use of ICSMS as a horizontal market surveillance tool is mandated 
by Regulation (EC) No 765/2008108. While it is not specifically tailored to fertilising products, the 
Commission considers that its general outline allows its use also for those products. A task force 

105  
106  

107  

108  

See Article 49a of Regulation (EU) 2019/1009. 
Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and 
repealing certain Directives (OJ L 312, 22.11.2008, p. 3, ELI: http://data.europa.eu/eli/dir/2008/98/oj). 
Regulation  (EC)  No 1107/2009  of  the  European  Parliament  and  of  the  Council  of  21 October  2009 
concerning  the  placing  of  plant  protection  products  on  the  market  and  repealing  Council  Directives 
79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).  
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the 
requirements for accreditation and market surveillance relating to the marketing of products and  repealing 
Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30, ELI: http://data.europa.eu/eli/reg/2008/765/oj). 

Page 68 of 109 

 
 
 
 
within the Administrative Cooperation Group for EU fertilising products is currently working on 
a guidance document to support authorities with the use of ICSMS for fertilising products. 

•  Sludge 

Some stakeholders called for allowing more types of sludge to be used as input for component 
materials. The Commission considers that such an amendment is not related to simplification and 
would require a specific scientific assessment.  

•  Removing the HAS assessment of harmonised standards 

A  representative  from  a  European  Standardisation  Organisation  (ESO)  suggested  removing  the 
step of an assessment by a consultant (‘HAS assessment’) after the publication of the European 
standard by the ESO and before the citation in the Official Journal. The Commission notes that 
the procedure for the assessment of harmonised standards is not set out in the FPR but is applied 
across legislation. It is therefore outside the scope of this targeted simplification exercise. 

D.  OVERALL CONCLUSIONS  

The measures proposed in this initiative would simplify requirements and streamline procedures 
under  Regulation  (EC)  No  1272/2008,  Regulation  (EC)  No  1223/2009  and  Regulation  (EU) 
2019/1009, with the aim and expectation of reducing costs and administrative burden for industry 
and authorities, while maintaining a high level of protection of human health and the environment.  

As  regards  classification,  labelling  and  packaging  of  chemicals,  the  proposed  measures  will 
simplify  and  allow  more  flexibility  for  the  formatting  rules  removing  the  excessive  costs  for 
industries.  The  savings  from  the  proposed  changes  to  the  font  size  requirements  and  related 
typographic rules for the EU chemicals sector could amount to at least €333 300 000  (from €31 
000 000 to €2 469 000 000). In addition, it will also alleviate the burden to businesses and improve 
the free circulation of substances and mixtures in the internal market lightening obligations for 
advertisements of hazardous substances and mixtures, and narrowing the scope of obligations to 
advertisements for the general public, saving EU chemicals sector on average from €20 000 up to 
€30 000 000 annually.  

As  regards  cosmetics,  it  is  challenging  to  quantify  precisely  the  cost  savings  for  businesses 
resulting from the proposed amendments to Article 15 of the CPR. While certain substances may 
be excluded from the ban, the obligation to conduct a safety assessment will remain where there 
are  human  health  concerns—particularly  in  the  case  of  substances  classified  as  CMR 
(carcinogenic,  mutagenic  or  toxic  to  reproduction). Accordingly,  industry  will  continue  to  bear 
some compliance costs. However, the proposed introduction of transitional periods is expected to 
yield  tangible  economic  benefits.  By  allowing  more  time  to  adapt  to  regulatory  changes,  these 
transitional periods enable businesses to better plan, adapt product portfolios, and make informed 
decisions.  This  flexibility  is  likely  to  reduce  the  need  for  immediate  product  withdrawals  and 
destruction, which can be especially costly when undertaken without prior notice. If, on average, 
the cost of sudden product withdrawal and destruction due to the absence of transitional periods is 
estimated at 1.75% of the sector’s turnover (based on an assumed range between 0.5% and 3%), 

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then the potential annual savings could reach approximately €1 680 000 000109 (sector turnover: 
€96 000 000 000  ×  1.75%).  Furthermore,  the  deletion  of  the  obligation  to  pre-notify  cosmetic 
products  containing  nanomaterials  is  projected  to  generate  additional  annual  savings  between 
€36 000 and €187 000 for industry. Similarly, the removal of reporting requirements for competent 
authorities is expected to save an estimated €130 000 annually. 

Beyond direct  cost  savings, these regulatory adjustments  are expected to  enhance operational 
efficiency. In particular, the changes would enable companies to better integrate compliance tasks 
into their regular planning cycles, thus avoiding disruptive mid-year reallocations of resources. 
The added predictability provided by transitional periods can be strategically leveraged: businesses 
may  choose  to  redirect  resources  previously  devoted  to  administrative  compliance  toward 
research, innovation, and competitiveness-enhancing activities. Overall, the amendments support 
a more efficient regulatory environment, allowing industry to maintain compliance while fostering 
long-term resilience and innovation. 

As regards EU fertilising products, the amendments are expected to foster the manufacturing and 
marketing  of  innovative  and  high-performing  EU  fertilising  products.  More  concretely,  the 
obstacle of the costs for complying with the extended REACH registration requirements (at least 
€19 220 000  for  the  whole  industry,  of  which  at  least  €187 586  for  registration  fees)  for 
substances in EU fertilising products would be removed. Manufacturers of fertilising products will 
likely have a greater choice of (affordable) substances that can be used in EU fertilising products, 
which may encourage them to market their products under FPR rules in the Single Market. Like 
this, they can save fees for national registrations (up to €50 000 per product per Member State) 
and adaptation costs (at an estimated range of €15 000 to €43 000 per product per Member State). 

The  amendments  also  pave  the  way  for  the  use  of  a  larger  variety  of  micro-organisms  in  EU 
fertilising products which will create economic opportunities in the EU and might reduce farmers' 
use of fertilisers. The streamlined assessment of those micro-organisms will also free up resources 
in the Commission which can be invested elsewhere.  

Moreover, the removal of the ‘unbundling clause’ would streamline the adoption of delegated acts, 
thereby freeing resources of stakeholders and the Commission and speeding up the inclusion of 
additional materials and the adoption of other necessary amendments to the component material 
categories. 

Finally,  the  digitalisation  of  reporting  requirements  can  reduce  the  administrative  burden  for 
companies and authorities linked to the handling of paper documents. 

109  

This  estimate  assumes  that  all  companies  would  avoid  this  level  of  forced  withdrawals  thanks  to  the 
transitional periods. It might be worth noting that this is probably a worst-case scenario maximum and actual 
realised savings would depend on the number and type of substances affected. 

Page 70 of 109 

 
 
 
 
 
 
 
ANNEX I 

REALITY CHECK ON THE POSSIBLE SIMPLIFICATION OF CHEMICALS LEGISLATION – 
CLASSIFICATION, LABELLING AND PACKAGING OF SUBSTANCES AND MIXTURES 
SYNOPSIS REPORT 

Meeting date: 16 May 2025, 9.00-12.30; 

Location: Online (Webex); 

Organised  by:  European  Commission  –  Directorate-General  for  Internal  Market,  Industry, 
Entrepreneurship and SMEs, Unit F2; 

Participants:  businesses,  practitioners  applying  EU  law,  consumer  and  business  associations, 
competent authorities; 

Number of registrants: 711; 

Number of participants who attended: 577. 

I. 

Welcoming  Remarks  and  Introduction  to  the  Commission  Simplification 
Initiatives 

The event opened with an introduction to the Commission’s policy on simplification and its new 
technical-level consultation tool, the “Reality Check.” The objective was to collect feedback of 
stakeholders (businesses, practitioners applying EU law, consumer and business associations as 
well  as  competent  authorities)  on  potential  simplification  of  the  Classification,  Labelling  and 
Packaging Regulation (CLP) following its revision via Regulation (EU) 2024/2865, with the aim 
for cost-savings and reduction of the administrative burdens. The context was the Commission’s 
broader simplification strategy to enhance EU competitiveness through streamlined legislation. 

II.  Mandatory Formatting Requirements 

A  significant  majority  of  participants  expressed  concern  about  the  mandatory  formatting 
requirements, especially minimum font sizes, line spacing, and black-on-white text obligations. 
Stakeholders highlighted the disproportionate economic burden these rules place on businesses, 
particularly in multilingual markets, and raised concerns about increased packaging waste, limited 
label space, and the high cost of fold-out labels. Numerous participants supported the use of digital 
tools (e.g. QR codes) as a supplementary or alternative means of conveying information. Others 
noted that the one-size-fits-all approach did not account for the diverse professional contexts (e.g. 
B2B transactions) where hazard  communication is  already ensured through Safety  Data Sheets 
(SDS). There  was  strong  and  repeated  support  for  “stopping  the  clock”  on  the  new  formatting 
requirements to allow for further analysis and adaptation. At the same time the concerns about the 
need  to  protect  consumers  and  workers  and  ensure  legibility  of  labels  and  provide  clear  and 
comprehensive hazard information were also raised. 

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III.  Rules on Advertisements 

Many  participants  criticised  the  broadened  requirements  for  advertisements  introduced  in  the 
revised CLP, particularly the obligation to include detailed hazard information (e.g. pictograms, 
signal  words  and  hazard  statements)  in  all  promotional  material.  Stakeholders  considered  this 
approach  disproportionate,  especially  in  comparison  to  advertising  rules  in  sectors  like 
pharmaceuticals. Concerns were raised about practical feasibility in modern digital formats (e.g. 
online banners, small-space media) and the risk of overwhelming consumers with excessive detail, 
thereby reducing  the  clarity of key safety  messages. The majority supported replacing  the new 
requirements with a simplified standard message such as “Always follow the information on the 
product  label.”  Several  participants  advocated  exempting  B2B  advertisements  from  these 
requirements entirely, citing the adequacy of SDS for professional users. 

IV.  Other Areas for Simplification in CLP Regulation 

Stakeholders raised a broad range of additional simplification opportunities. Key topics included: 

•  Placing vs. making available on the market: Calls were made to align CLP with other 
NLF  product  legislation  by  distinguishing  these  concepts,  to  reduce  unnecessary  stock 
reclassification. 

•  Poison Centre Notifications (PCN): Numerous participants described the current system 
as  burdensome  and  fragmented,  with  inconsistent  national  requirements  and  high 
associated costs. Centralisation via ECHA was proposed. 

•  Unique  Formula  Identifier  (UFI):  Several  actors  requested  flexibility  in  UFI 
requirements,  particularly  for  fuels,  where  the  diversity  and  mixing  of  supplies  makes 
practical implementation extremely difficult. 

•  Self-classification labelling deadlines: Strong support emerged for aligning the six-month 
deadline  for  self-classified  substances  with  the  18-month  timeline  used  for  harmonised 
classifications. 

•  Digitalisation:  Many  stakeholders  advocated  expanding  the  legal  basis  for  digital 
labelling, especially in B2B and multilingual contexts, to complement or partially replace 
on-pack information. 

•  Harmonised  Classification  and  Labelling  (CLH):  Industry  and  NGO  representatives 
agreed on the need to streamline the CLH process. Proposals included allowing better use 
of new data, clarifying  exposure routes, and automatically updating Annex VI based on 
scientific opinions. 

•  Mixture  classification  and  expert  judgment:  Particularly  for  detergents,  stakeholders 
warned that limitations on the use of expert judgment and weight-of-evidence approaches 
could lead to disproportionate and misleading classifications. 

•  Label  updates  and  stock  management:  Several  stakeholders  noted  that  short 
implementation timelines could lead to product and label waste, undermining the Green 
Deal and packaging legislation. 

•  Terminology  clarity:  Calls  were  made  to  better  define  “advertisement”  and  “distance 

sales” in the CLP to avoid compliance ambiguities.  

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Conclusions 

V. 
•  The new formatting requirements, particularly font sizes and line spacing, were considered 
excessively burdensome by a wide range of stakeholders. Many called for a pause in their 
implementation and proposed a more flexible, digitally enabled approach. 

•  The revised rules on advertisements were widely criticised for being disproportionate and 
lacking  clarity.  A  simplified  approach  focusing  on  referencing  the  product  label  was 
strongly supported. 

•  Multiple suggestions were made for further simplification of the CLP Regulation, including 
aligning timelines, clarifying key definitions, streamlining the CLH and PCN processes, 
and enhancing digitalisation. 

•  Stakeholders were invited to submit written contributions by 31 May 2025 (or 1 June at 
the latest), particularly with quantifiable evidence to support simplification proposals. 

•  The Commission will prepare a report to inform political decision-making. 

VI. 

Summary of poll results 

a. Mandatory formatting requirements 

First poll focused on mandatory formatting requirements and consisted of six questions, including 
one  open-ended  question.  222  participants  in  total  provided  their  replies,  while  open  question 
gathered  55  qualitative  responses.  The  objective  of  this  poll  was  to  evaluate  the  stakeholders’ 
perception of the new rules on formatting introduced by the Regulation 2024/2865, identify key 
concerns, and propose actionable next steps. 

Question 1. Perceived Burden of CLP Formatting Requirements: 

- 75% of respondents believe the new formatting rules impose significant and unjustified 
burdens. 

- Only 6% think the requirements are justified or not burdensome. 

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Figure 1: Perceived Burden of CLP Formatting Requirements 

Question 2. Need for Simplification: 

- 80% see potential for simplification and burden reduction. 

- Only 6% see no need for change. 

Figure 2: Potential for Simplification of Formatting Requirements 

Question 3. Elements That Could Be Simplified: 

- Font sizes and line spacing (75% each) are top concerns. 

- Black-on-white requirement (44%) and letter spacing (35%) also notable. 

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Figure 3: Elements of Formatting Requirements That Could Be Simplified 

Question 4. Font Size Simplification Options: 

- 38% of respondents indicated their preferences for  mandatory font sizes  to  be  deleted 
entirely. 

- 32% support deletion of mandatory font sizes for B2B use. 

- 23% favour exemptions when space is insufficient. 

Figure 4: Proposed Options Regarding Font Sizes 

Question 5. Formatting Requirement Changes: 

- 25% of respondents indicated their preferences for mandatory line spacing obligations to 
be removed. 

- 19% advocate for deletion of all formatting requirements. 

Page 75 of 109 

 
 
 
 
 
 
- 15% support B2B exemptions. 

- 8% suggest replacing “black on white” with “sufficient contrast”. 

Figure 5: Proposed Options Regarding Formatting Requirements 

Question 6: Other solutions. Insights from 55 open responses: 

•  “Stop  the  Clock”:  Widespread  support  for  pausing  implementation  until  impact 

assessment is complete. 

•  Flexibility by Packaging and Use Type: Requests for exemptions based on packaging 

size, product type, or distribution channel. 

•  Remove or Ease Formatting  Requirements:  Suggestions to  remove font size, line 

spacing, and other prescriptive formatting rules. 

•  Embrace Digital Labelling: Many propose QR codes and digital options to declutter 

physical labels. 

•  Revert or Align with Past Rules: Support for returning to previous CLP rules or to 

align font sizes with food sector rules. 

•  Criticism  of  Policy  Process:  Calls  for  formal  consultation  and  data-driven  policy 

rather than workshop-based polling. 

b. Rules on advertisements 

Second poll on rules on advertisements collected quantitative feedback from 168–171 participants, 
and 22 qualitative replies to an open question. The poll explored perceived burdens, adequacy of 
new requirements on advertisements introduced by Regulation 2024/2865, stakeholders’ views on 
simplification potential, and open-ended proposals for improvement. 

Page 76 of 109 

 
 
 
 
 
Question 1. Perceived Burden of Advertisement Requirements: 

•  59% believe the new rules impose significant and unjustified burdens and costs. 
•  20% consider them moderately burdensome. 
•  Only 3% believe the rules are fully appropriate. 

Figure 6: Perceived Burden of Advertisement Requirements 

Question 2. Usefulness of Hazard Info in Advertisements: 

•  55% believe that providing hazard information in advertisements does not help end-

users make more informed choices. 

•  Only 35% believe it does. 

Figure 7: Does hazard information in advertisements helps making informed decisions 

Question 3. Adequacy of Hazard Info on the Product Label: 

Page 77 of 109 

 
 
 
 
 
 
•  87% believe the product label already provides adequate hazard information. 
•  Only 9% disagree. 

Figure 8: Adequacy of Hazard Information on the Product Label 

Question 4. Potential for Simplification of Advertisement Provisions: 

•  80% see potential for simplification and burden reduction. 
•  Only 6% say no changes are needed. 

Figure 9: Potential for Simplification of Advertisement Provisions 

Question 5. Specific Simplification Proposals: 

•  57%  prefer  removing  hazard  information  requirements  but  keeping  the  invitation  to 

read the label. 

•  28% prefer removing requirements for B2B advertisements. 
•  21% support removing the requirement across all advertisements. 

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Figure 10: Preferred Simplification Measures 

Question 6. Other solutions. Insights from 22 open responses: 

•  Excess Burden for B2B: Many believe that advertisements targeting B2B audiences 

should be exempt since SDS is already provided. 

•  Comparison  with  Other  Legislation:  Participants  cite  excessive  requirements  in 
comparison with other EU regulations, such as pharmaceuticals, biocidal products and 
plant protection products. 

•  Need for Clearer Definitions: Calls for clarification on what constitutes ‘advertising’ 

and better guidance on digital media usage. 

•  Risk of Confusion or Information Overload: Some warn that excessive hazard info 

on advertisements may confuse users and reduce label engagement. 

•  Suggestions for Simplification: Limit advertisements content to symbols or general 

references to product information; redirect users to the label or SDS. 

c. Other burdensome provisions 

Third poll consisted of two open questions suggesting participants to indicate other CLP provisions 
that are too burdensome and costly and to propose measures for simplification of these provisions. 
These two questions yielded 49 and 48 qualitative responses respectively. 

Question 1. Indication of other burdensome CLP provisions. Insights from 49 open 
responses: 

•  Short Timelines & Implementation Pressure - Multiple stakeholders stressed that 6-
month  deadlines  for  implementing  classification  changes,  labelling  updates,  PCN 

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notifications, and MOCS were unrealistic. The 18-month timeline was repeatedly cited 
as a more workable standard. 

•  C&L Inventory and PCN Notification Burden - Respondents flagged the duplication 
and  inefficiency  of  CLP  notification  processes  –  particularly  PCN  requirements. 
Inconsistent national procedures and the lack of a central system were noted as major 
issues. 

•  UFI  On  Fuelling  Stations  -  The  requirement  to  display  UFI  at  fuel  pumps  was 

highlighted as excessive and non-beneficial from a safety perspective.  

•  MOCS Rules - The classification burden for MOCS was seen as excessive and non-
beneficial from a safety perspective. Several proposed a removal of these rules entirely. 
•  Hazard Classification & Label Content Overload - Numerous comments criticized 
the  complexity  of  label  content,  citing  too  many  hazard  (H)  and  precautionary  (P) 
statements, oversized pictograms, and over-specified EUH text.  

•  Digitalisation - There was strong support for more use of digital labels and QR codes. 

Respondents recommended removing non-essential content from labels. 

•  Centralisation of PCNs - Stakeholders emphasised creating a single, centralised PCN 

system managed by ECHA to reduce redundancy and streamline compliance. 

•  Misalignment  with  Other  Regulations  -  Many  noted  conflicts  between  CLP  and 
REACH, GHS, and downstream legislation such as on detergents and cosmetics.  
•  Ambiguity  &  Interpretation  Issues  -  Several  comments  emphasized  the  lack  of 
clarity  around  terminology  such  as  ‘placing  on  the  market’  or  ‘product  identifier’, 
which leads to differing interpretations and regulatory uncertainty. 

Question 2: Simplification proposals. Summary of 48 replies: 

•  Extend relabelling deadlines from 6 to 18 months. 
•  Centralize PCN submission through ECHA. 
•  Exempt from UFI requirements to certain mixtures. 
•  Remove MOCS rules. 
•  Move non-critical content to digital labels. 
•  Discontinue or limit C&L Inventory requirements. 
•  Clarify ambiguous legal terms and processes. 
•  Harmonise CLP obligations with GHS and downstream legislation. 
•  Align multiple application deadlines coming from different CLP amendments. 

Page 80 of 109 

 
 
 
 
 
ANNEX II 

DETAILS ON THE COSTS AND SAVINGS ANALYSIS  
FOR THE CHANGES TO FONT SIZE REQUIREMENTS 

In this section, we develop the analysis of costs, savings and benefits from the proposed provisions 
on font size requirements and other label formatting rules. 

To  the  extend  possible,  the  analysis  was  performed  in  accordance  with  the  Better  Regulation 
principles,  using  available  data,  from  previous  impact  assessment  analysis,  together  with  input 
gathered via the reality check. 

A.  ANALYSIS FOR THE DETERGENT SECTOR 

Baseline: the future  provisions  apply  as laid down in  Regulation  (EU)  2024/2685. This  means 
companies have to analyse the design of their current labels, compare them to the future rules and 
select the most cost-effective solution(s) to comply with the upcoming rules on 1 January 2027. 
This  means  they  would  be  considering  at  the  time  this  Staff  Working  Document  is  developed 
investing in new equipment, selecting new label providers and relabelling on the short term their 
products to comply with the rules on time. 

Option analysed: the Commission simplification omnibus on chemicals proposes to remove the 
detailed  label  formatting  rules  (minimum  font  sizes,  minimum  line  spacing  and  background 
colour) while keeping the overall obligation of easy-to-read labels, completed by ECHA guidance. 

An evaluation of two extreme scenarios was performed, depending on the adaptive choice(s) of 
companies to comply with Regulation (EU) 2024/2865: either to set monolingual 2D labels for all 
products or just update their labels, regardless of whether they are 2D ones or fold-out ones or to 
turn all their labels into fold-out ones. From the input received, it is not possible to quantify the 
proportion  between  the  three  scenarios.  Stakeholders  reported  difficulties  in  some  cases  with 
fitting a monolingual label on existing packaging. Others reported difficulties to extend the number 
of pages of existing fold-out labels to comply with the label requirements. A significant share of 
stakeholders reported higher labelling costs because of switching to fold-out labels. 

To the extend possible, the analysis was performed using three hypothesises, minimum, medium 
or higher impacts, to give an idea of its sensibility. 

Period  considered:  20  years,  from  2025.  It  is  assumed  that  design  updates  and  relabelling  of 
products would happen ahead of the end of the transition period laid down in Regulation (EU) 
2024/2685. 

Parameters used: 

•  Ratio of labels of hazardous mixtures to be updated: depending on feedback received, a 

range between 70% to 100% was used. 

Page 81 of 109 

 
 
 
 
•  Costs to redesign labels: according to the Impact Assessment accompanying the proposal 
for a targeted revision of CLP110, the cost to redesign a 2D label for a hazardous mixture 
was €475 in 2022. The cost for the (re)design of a fold-out label was considered higher, 
between €500 and €1 000111. 

•  Cost of a label: from the input received in the reality check the price of 2D/simple labels 
is  considered  as  €0.03 (€0.01  – €0.05) and for a fold-out  label  as  €0.10 (€0.03  – €0.5). 
Stakeholders  reported  an  increase  cost  ranging  from  +70%  to  +900%,  with  a 
median/average of +200%, which was applied in this analysis.  

•  Future relabelling rate: it is understood that labels need  repeated updates, to mirror the 
changes in classification of the mixture or its components. ECHA estimates that 1% per 
year of substance classification are updated in the classification and labelling inventory112. 
Considering that a substance would be in 11 mixtures or 25 mixtures113, the rate of label 
updates for mixtures taken into account in this analysis is 11% per year (5% - 25%). There 
is significant uncertainty about the exact number of mixture classification update per year, 
hence  of  label  updates;  mixtures  contain  multiple  substances  by  definition,  the 
concentration  of  these  substances  reclassified  may  vary,  triggering  or  not  a  change  of 
classification  of  the  mixture.  But  it  is  reasonable  to  assume  that  mixtures  would  be 
reclassified at least once in 9 years (every 4th year to every 20th year). 

•  Current  number  of  labels  per  products:  the  CLP  IA  identifies  that  for  detergent 
companies114, that SMEs would place their products in 5 MS and larger companies in 15 
MS. The Impact Assessment accompanying the proposal for a targeted revision of the CLP 
Regulation  is  unclear  whether  currently  companies,  regardless  of  their  sizes,  have 
monolingual or multilingual labels. From the feedback received in the Reality Check, it 
seems that across sectors, both SMEs and large companies already have multilingual labels. 
There are two mean reasons for this: first there are multiple MS or countries in the EEA or 
with significant trade with MS where various languages on the CLP label are required (e.g. 
Belgium with 3 languages, Finland with 2, Switzerland with 3); second businesses have 
developed  products  for  groups  of  MS,  most  probably  with  a  combination  of  required 
languages, in order to save costs and break even for specific SKUs. The point at which an 
SKU breaks even depends on many factors which are specific to companies, products, the 
size  of  required  CLP  label  elements  and  markets.  In  order  to  test  the  variability  and 
sensitivity of this analysis, the following combination were tested. 

•  Number of companies: the evaluation of the Detergent Regulation115 reported about 700 
companies in the sector of detergents in the EU, with 85% of SMEs (about 595 companies). 

110  
111  
112  
113  
114  
115  

Impact Assessment for the Revision of CLP, p. 220. 
Impact Assessment for the Revision of CLP, p. 341. 
Impact Assessment for the Revision of CLP, p. 302. 
Impact Assessment for the Revision of CLP, p. 197. 
Impact Assessment for the Revision of CLP, p. 341. 
Commission  Staff  Working  Document  –  Evaluation  of  Regulation  (EC)  No  648/2004  of  the  European 
Parliament 
detergents 
of 
Council 
of 
https://ec.europa.eu/docsroom/documents/36289. 

March 

2004 

and 

the 

on 

31 

Page 82 of 109 

 
 
 
 
The CLP IA used 50 large companies and 600 to 650 SMEs (medium: 625). In order to 
allow some comparisons, figures from the CLP IA were used. 

•  Number of products per company: figures from the CLP IA116 were reused (200 products 
per large companies – from 150 to 250 – and 50 products per SME – from 40 to 60). 
•  Number of labels per year were estimated from the limited input received. ‘Future label 
number’  reflects  the  situation  where  Regulation  (EU)  2024/2865  is  fully  implemented. 
‘Current label number’ refers to the situation before Regulation (EU) 2024/2865 was not 
published,  and  where  no  companies  have  taken  steps  to  adapt  the  labels  and  labelling 
processes to that regulation. 

•  One-off  costs  were  calculated  as  follows:  Cost  =  %labels  to  be  updated  *  (number  of 
products  per  company  *  number  of  future  labels  per  product  *  cost  for  label  update  * 
number of products + cost of a label * number of labels) 

•  Recurring costs are the costs borne by companies when updating labels because of future 
classification update. The costs are born only for the adapted labels in line with Regulation 
(EU) 2024/2865 and to the extent of mixtures which classification is amended. It calculated 
as follows: recurring cost = %labels to be updated * relabelling rate per year * (cost of a 
label * number of labels per year + number of future labels per product* number of products 
per company * cost redesign difference). 

Results  are  displayed  in Table  8.  From  the  various  estimates  and  despite  the  great  uncertainty, 
significant total annualised costs to comply with Regulation (EU) 2024/2865 are identified, for 
both  SMEs  and  larger  companies,  with  the  largest  range  between  about  €2 100 000  and 
€123 700 000 for the scenario of fold-out  labels.  It is  worth  noting that  the middle estimate of 
annual  costs  (annualised  one-off  costs  and  recurrent  costs)  of  all  three  scenarios  is  around  or 
slightly above €14 000 000. 

In  reality,  companies  may  combine  the  three  different  scenarios  and  apply  different  solutions 
within their portfolios. The similar order of the magnitude of these labelling costs may not lead 
companies to favour one scenario over the other two. However associated costs may play in greater 
role in that sense, as the scenarios imply different evolutions of the number of SKUs per company 
and the need or not to invest in new labelling equipment or storage facilities. 

116 Impact Assessment for the Revision of CLP, p. 341/ 

Page 83 of 109 

 
 
 
 
 
 
Ratio of labels to 
redesign 

Cost to redesign 
labels 

Current cost of a 
label 
Future cost of 
label 

  Relabelling rate 

Current label 
numbers 
Number of 
languages 
covered 

Future label 
number 

Number of 
products 

Number of 
companies 

s
e
i
n
a
p
m
o
c

e
g
r
a
L

Number of labels 
printed per year 
per company 

One-off cost per 
company 

Table : Cost estimates for detergent sector 

Only reformatting the label  

Only monolinguistic 2D labels 

Only fold-out labels 

Min 

Middle 

Max 

Min 

Middle 

Max 

Min 

Middle 

Max 

70% 

1 000 

0.05 

0.05 

0.05 

3 

15 

3 

150 

50 

90% 

100% 

70% 

90% 

100% 

70% 

90% 

100% 

750 

475 

475 

475 

475 

500 

750 

1 000 

0.03 

0.05 

0.11 

7 

15 

7 

0.01 

0.10 

0.25 

15 

15 

15 

0.01 

0.03 

0.05 

15 

15 

15 

0.01 

0.03 

0.11 

7 

15 

15 

0.01 

0.05 

0.25 

3 

15 

15 

0.30 

0.50 

0.05 

3 

15 

3 

0.10 

0.50 

0.11 

7 

15 

7 

0.01 

0.50 

0.25 

15 

15 

15 

200 

250 

150 

200 

250 

150 

200 

250 

50 

50 

50 

50 

50 

50 

50 

50 

500 000 

2 500 000 

10 000 000 

500 000 

2 500 000 

10 000 000 

500 000 

2 500 000 

10 000 000 

332 500 

1 001 250 

1 881 250 

751 625 

1 305 000 

1 881 250 

262 500 

1 170 000 

3 850 000 

Page 84 of 109 

 
 
 
 
 
 
 
 
 
 
 
 
 
Recurring 
labelling cost per 
company 
Total one-off 
cost 
Total recurring 
cost 

Current label 
numbers 
Number of 
languages 
covered 

Future label 
number 

Number of 
products 

Number of 
companies 

s
E
M
S

0 
16 625 00
0 

6 188 

225 000 

50 062 500 

94 062 500 

350 
37 581 25
0 

6 390 

103 000 

65 250 000 

94 062 500 

3 500 
13 125 00
0 

99 080 
58 500 00
0 

1 225 000 
192 500 00
0 

0 

1 

5 

1 

40 

600 

309 375 

11 250 000 

17 500 

319 500 

5 150 000 

175 000 

4 950 000 

61 250 000 

3 

5 

3 

5 

5 

5 

5 

5 

5 

3 

5 

5 

1 

5 

5 

1 

5 

1 

3 

5 

1 

5 

5 

1 

50 

60 

40 

50 

60 

40 

50 

60 

625 

650 

600 

625 

650 

600 

625 

650 

Number of labels 
printed per year 
per company 

One-off cost per 
company 

Recurring cost 
per company 
Total one-off 
cost 
Total recurring 
cost 
o
 Total one-off 
t
c
cost 
e
s

r

30 000 

29 050 

0 
17 430 00
0 

0 
34 055 00
0 

l
o
h
W

e

100 000 

500 000 

30 000 

100 000 

500 000 

30 000 

100 000 

500 000 

103 500 

147 500 

66 500 

106 875 

142 500 

4 200 

10 125 

3 000 

248 

11 250 

64 687 500 

95 875 000 

21 
39 900 00
0 

288 

5 240 

210 

3,870 

61,010 

66 796 875 

92 625 000 

2 520 000 

6 328 125 

1 950 000 

154 688 

114 750 000 

7 312 500 
189 937 50
0 

12 600 
77 481 25
0 

180 000 
132 046 87
5 

3 406 000 
186 687 50
0 

126 000 
15 645 00
0 

2 418 750 
64 828 12
5 

39 656 500 

44,450,000 

Page 85 of 109 

 
 
 
 
 
Total annualised 
one-off cost 
Total recurring 
cost 

3 992 285 

13 452 201 

22 266 469 

9 083 166 

15 479 922 

21 885 470 

1,051,590 

2,542,644 

0 

464 063 

18 562 500 

30 100 

499 500 

8 556 000 

301 000 

2,987,738 
100 906 50
0 
123 701 97
2 

7 368 750 
14 968 58
4 

Super total per year 

3 992 285 

13 916 263 

40 828 969 

9 113 266 

15 979 422 

30 441 470 

2 135 071 

Page 86 of 109 

 
 
 
 
B.  LUBRICANTS 

Some large to very large manufacturers of lubricant and an SME share granular details about the 
impact of Regulation (EU) 2024/2865 on their portfolio. They gave details about the restructuring 
of  their  SKU,  the  additional  cost  of  labels  compliant  with  that  Regulation,  without  confirmed 
differentiation  that  future  labels  would  all  be  fold-out  ones.  Interestingly,  depending  on  the 
company, the product type or size, the impacts ranged from nothing to very significant costs.  

Table 9 gives an overview of the aggregation of the data received. 

Table : Cost estimates for lubricant sector 

Number of 
companies 

Rate of SKU impacted 
Increased of SKU 
Price for additional 
SKU 
Increase of labelling 
costs (1st relabelling) 
Investment in new 
equipment 
Recurrent relabelling 
Annualised total one-
off costs 

7 

3 

6 

5 
6 

(6) 

Minimum reported 
27% 
€550 

2 000 000 

2 000 000 

80 000 
27 000 

Total (€) 

Maximum 
reported 
100% 
€25 000 

Reporting 
companies 
N/A 
48 834 

34 500 000 

46 500 000 

6 900 000 

26 807 100 

3,200,000 
1,725,000 

6 927 585 
2 885 378 

Lubricant 
sector 
- 
- 
- 

53 614 200 

13 855 170 

5 770 756 

Total annual(ised) costs 

59 502 537 

2 360 629 
119 005 074 

C.  OVERALL DISCUSSION FOR THE EUROPEAN CHEMICAL SECTOR 

According to the estimates developed for detergents and facts reported for the sectors of lubricants, 
there is concurring evidence showing that there are both one-off costs and recurrent consequences 
stemming from Regulation (EU) 2024/2865, which were not highlighted in the CLP IA.  

From the analysis performed for the detergent sector and the account of this sector (4.2% in 2018) 
in  the  production  value  of  the  total  chemicals  sector  in  the  EU,  the  saving  from  the  proposed 
changes to the font size requirements and related typographic rules for the EU chemicals sector 
could amount to at least €333 300 000 (from €31 000 000 to €2 469 000 000).  

The possible costs to the whole EU chemical industry were extrapolated from estimates calculated 
for the detergent and lubricant sectors. Some stakeholders also reported total one-off costs for a 
national sector or national chemical industry. Table 10 illustrates the order of magnitude derived 
from these extrapolations. 

Page 87 of 109 

 
 
 
 
 
 
 
 
 
 
 
 
Table 10: Extrapolation of costs estimated for some sectors or national markets  

Source 

Detergent sector 
(calculated) 
Lubricant companies 
(calculated) 
National paint and 
ink sector (reported) 
Member State 
(reported) 
National chemicals 
sector 

Share of EU 
chemicals 
production value 

Annual cost  One-off cost 

4.20% 

14 000 000 

Extrapolation 
to EU 
chemicals 
industry 

333 000 000 

1.16% 

119 005 074 

10 260 000 000 

0.09% 

1.32% 

11.22% 

60 000 000 

4 481 000 000 

50 000 000 

255 000 000 

583 000 000 

349 000 000 

Type of cost117 

Annual overall 
cost 
Annual overall 
cost 
Annualised one-
off cost 
Annualised one-
off cost 
Annualised one-
off cost 

The  proposed  change  should  hence  limit  indirect  and  adjustment  costs  estimated  above. While 
those estimated bear significant uncertainty, table D looks at the plausibility and likelihood of such 
impacts to materialise and to what extent. 

Table : Estimated plausibility of various impacts identified for detergents and lubricants 

Scenario 

Only reformatting labels 

Increased SKU 

Neutral 

Only  monolinguistic  2D 
labels 
Certain 

Increased  price  of  labels, 
including  cases  where 
other label elements than 
CLP  ones  on  another 
medium 
Change 
equipment 

labelling 

of 

Change of packaging 

by 

Likely  as  reported  in  some 
cases 
stakeholders 
(increased  number  of  pages 
in a fold-out label, increased 
size of labels) 
Possible as reported in some 
cases  (linked  to  increased 
price of labels) 

Possible 
(outer  packaging 
mainly) as indicated by some 
stakeholders. 

other 

Placing 
label 
elements  than  CLP  ones 
on another medium 
Loss of (smaller) market   Neutral 

Likely, unless existing labels 
are fold-out ones. 

Neutral,  unless  label  size 
has  to  be  increased,  as 
pointed  out  by 
some 
stakeholders. 

Neutral,  unless  label  size 
has  to  be  increased,  as 
pointed  out  by 
some 
stakeholders. 
Unlikely  but  plausible  in 
specific  situations  where 
limited  space  would  be 
no 
available 
derogation possible. 
Possible 

and 

Highly certain 

Only fold-out labels 

Possible  if  the  space  increase 
needed  does  not  fit  in  a  fold-out 
label (some stakeholders reported 
issues  with  bigger  packaging  or 
labels with more than 10 pages). 
Certain, all stakeholders reported 
fold-out labels being more  

Certain  for  many  companies  not 
using  fold-out  labels  yet  and 
reporting they would be forced to 
move to fold-out labels 
No 

Unlikely 

117  

The conversion to annualised present value is based on 3% discount rate and a period of 10 years. 

Page 88 of 109 

 
 
 
 
 
 
 
 
 
 
 
 
ANNEX III 

REALITY CHECK ON THE POSSIBLE SIMPLIFICATION OF CHEMICALS LEGISLATION –  
COSMETIC PRODUCTS REGULATION 
SYNOPSIS REPORT 

Meeting date: Friday , 16 May 2025, 14:00-17:30 

Location: Webex; 

Organised  by:  European  Commission  –  Directorate-General  for  Internal  Market,  Industry, 
Entrepreneurship and SMEs, Unit F2 

Participants:  Representatives  from  the  Commission,  Member  States  authorities,  industry 
associations, and NGOs  

Number of registrants: 268 

Number of participants who attended: 226 

1.  Welcoming  Remarks  and 
Simplification Initiatives 

Introduction 

to 

the  Commission 

The Commission outlined the general context and political priorities of the current mandate, with 
particular  focus  on  simplifying  and  streamlining  EU  rules  to  boost  EU  competitiveness.  The 
Commission presented the Reality Checks as new technical-level consultation tools designed to 
support  the  Commission’s  simplification  agenda.  The  objective  of  this  specific  Reality  Check 
event was to identify opportunities to simplify the Cosmetic Products Regulation118 and reduce 
administrative and compliance burdens, while maintaining high standards of consumer safety and 
industry compliance.  

Participants were invited to share their views through oral interventions, contributions in the chat, 
and responses to questions posted via Slido119.  

2. 

Cosmetic Products Regulation - potential areas for simplification and 
burden reduction  

118  

119  

Regulation (EC) No 1223/2009 of the European Parliament and of  the Council of 30 November 2009 on 
cosmetic products (OJ L 342, 22.12.2009, p. 59, ELI: http://data.europa.eu/eli/reg/2009/1223/oj). 
Slido  is  the  audience  interaction  platform.  It  helps  users  to  get  the  most  out  of  meetings  and  events  by 
crowdsourcing  top  questions  and  engaging  participants  with  live  polls  and quizzes.  More  information on  
https://www.slido.com/ 

Page 89 of 109 

 
 
 
 
 
 
 
 
 
a.  Reducing administrative and compliance burden related to CMR 

classified ingredients (Article 15) 

Based  on  earlier  input  from  stakeholders,  the  Commission  services  compiled  a  list  of  issues 
relating  to  the  implementation  of  Article  15  of  the  CPR,  which  have  created  interpretation 
challenges  and  which,  according  to  industry,  imposed  a  significant  burden  on  the  cosmetic 
industry.  Several  participants  agreed  that  changes  to  Article  15  would  be  essential,  notably 
stressing  the  importance  of  realistic  transitional  periods,  which  they  felt  should  be  explicitly 
provided  in  the  CPR.  Additionally,  several  participants  expressed  that  the  prohibitions  under 
Article  15(1)  and  (2)  should  not  apply  to  the  natural  complex  substances,  even  if  one  of  their 
constituents has received a harmonised classification as a CMR substance.  

Stakeholders broadly welcomed the proposed amendments, including the suggestion to link the 
ban in Article 15 to actual dermal exposure to the CMR substance. 

Some participants emphasised the need for reassurance that any simplification initiative in the area 
of  cosmetics  should  not  compromise  the  core  policy  objectives  of  the  CPR.  Specifically,  they 
underlined that the harmonised classification of a substance as a CMR must continue to trigger a 
ban  on  its  use  in  cosmetics,  and  that  derogations  from  this  ban  should  only  be  granted  in 
exceptional  cases.  Others  stressed  that  the  CPR  must  continue  protecting  consumers  from  the 
harmful chemicals and cautioned against excessively long transitional periods, warning that they 
could prolong consumers exposure to hazardous substances. 

One  stakeholder  also  raised  a  question  about  how  this  simplification  initiative  relates  to  other 
ongoing workstreams, including the full-fledged evaluation of the CPR and the activities of the 
Working Group on Cosmetic Products regarding the revised CMR Guidelines. 

Responses to Slido questions indicated that, among five simplification measures, the top three - 
introducing  transitional  periods,  clarifying  the  approach  to  natural  complex  substances,  and 
simplifying the criteria for derogations - were seen as the most impactful in reducing regulatory 
and administrative burdens on the cosmetics industry. Specifically, 48% of respondents believed 
that all five proposals were to significantly streamline business operations, while 31% considered 
the benefit to be as moderate. Only 6% felt the impact would be marginal or negligible (see Slido 
results). 

b.  Facilitating the addition of colorants, preservatives, and UV filters 

to Annexes IV–VI 

Most  participants  agreed  that  establishing  a  specific  procedure  for  introducing  colorant, 
preservatives and UV-filters in Annexes IV – VI of the CPR, respectively, would be beneficial. A 
stakeholder suggested that, as part of this procedure, the SCCS should be tasked with reviewing 
the  safety  of  all  substances  in  the  positive  lists  every  10  years,  like  the  review  process  under 
REACH authorisations. 

According to Slido responses, 67% of participants supported introducing such a procedure, citing 
improvements in clarity and regulatory certainty. Nearly 20% were also in favour but noted that 
certain aspects would still require further clarification (see Slido results in the Annex). 

Page 90 of 109 

 
 
 
 
c.  Streamlining  requirements  under  Article  33  on  the  glossary  of 

cosmetic ingredients  

The  Commission  sought  stakeholders’  views  on  the  relevance  of  the  glossary  of  common 
ingredient names, suggesting it could be replaced by a reference in the CPR to the internationally 
recognised cosmetic ingredient nomenclature. During the discussion, many participants expressed 
a  preference  for  retaining  the  glossary  as  a  source  of  legally  binding  ingredient  names  but 
recommended that it be made in an electronic format  – integrated into CosIng – to allow more 
frequent updates and provide significantly improved user experience.  

Some  stakeholders,  however,  argued  that  the  glossary  is  either  no  longer  necessary  or  would 
require substantial improvements to remain useful. These diverging views were reflected in the 
Slido results: 50.2% of respondents considered the glossary to be of limited value and believed it 
could  be  discontinued  without  major  impact.  Conversely,  41%  felt  that  the  glossary  should  be 
maintained  or  found  it  useful  but  noted  that  improvements  were  needed  in  terms  of  accuracy, 
format and the frequency of updates (see Slido results in the Annex). 

3. 

Reducing notification and reporting obligations  
a.  Prenotification 

requirements 

for 

products 

containing 

nanomaterials (Article 16) 

Article 13 of the Cosmetic Products Regulation requires businesses to notify to the Commission 
all cosmetic products before they are placed on the market. In addition, if those products contain 
nanomaterials, they have to comply with additional notification requirements, as information about 
such products including detailed data on nanomaterials, must be transmitted to the Commission 
six  months  before  placing  them  on  the  market  (Article  16  of  the  CPR).  This  pre-notification 
requirement  for  cosmetic  products  containing  nanomaterials  has  been  considered  burdensome. 
Suggestions for improvement included simplifying the notification processes by relying on Article 
13 of the CPR to reduce industry costs without compromising product safety. 

According  to  Slido  results,  approximately  61%  of  respondents  agreed  that  the  pre-notification 
requirements impose significant and disproportionate burdens and costs on the cosmetic industry. 
Meanwhile, 14% considered the burden to be manageable, and 3.2% believed the current process 
is appropriate and does not result in unnecessary costs (see Slido results in the Annex). 

b.  Market surveillance reporting obligations (Article 22) 

Article 22 of the Cosmetic Products Regulation requires Member States to periodically review and 
assess the functioning of their surveillance activities and communicate the results of such review 
to  the  other  Member  States  and  the  Commission  and  made  them  available  to  the  public.  This 
obligation  places  an  unnecessary  burden  on  competent  authorities  as  existing  tools,  such  as 
ICSMS, are already used for reporting and sharing information on market surveillance measures 
among EU competent authorities. Additionally, PEMSAC – the platform for market surveillance 
bodies for cosmetics, supports a coherent approach to enforcing the Cosmetic Products Regulation.  

Page 91 of 109 

 
 
 
 
 
Some participants cautioned against introducing measures that could weaken EU-level oversight 
of national market surveillance activities. This cautious stance was reflected in responses to the 
Slido question: ‘Do you consider that the deletion of the reporting obligations would reduce burden 
on competent  authorities?’ Most respondents did not express a clear opinion. However, among 
those who did respond, half believed that removing the obligation would result in significant or 
moderate reduction in administrative burden (see Slido results in the Annex). 

4.  Other Areas for Simplification in Cosmetic Products Regulation 
Stakeholders raised a broad range of additional topics that could be included in the simplification 
process, including:  

• 

• 

• 

• 

• 

• 

• 

• 

Animal testing and microplastics (under REACH): these were identified as areas 
where reducing reporting obligations could significantly benefit businesses. 
Transition periods  for placing new products on the market:  Several  participants 
called  for  harmonised  transition  periods  in  Commission  decisions  concerning 
ingredients whose safety has been confirmed. Some suggested that the changes to the 
CPR  should  be  adopted  once  per  year  on  a  fixed  date,  with  aligned  transposition 
deadlines to facilitate planning and implementation. 
Labelling of cosmetic products: suggestions included improving labelling accuracy, 
adding  CPNP  numbers  and  expiration  or  validity  dates  to  product  packaging. 
Stakeholders highlighted the potential of voluntary digital labelling -particularly for the 
list  of  ingredients-  to  reduce  burdens  and  improve  consumer  access  to  information. 
Some  participants  proposed  that  labelling  information  should  be  available  only  in 
English, arguing that translation requirements are unnecessary. 
Online sales rules – participants called for the CPR to include specific provisions for 
cosmetics sold online, including requirements for label information to be displayed on 
the websites and online marketplaces offering products to EU consumers. 
Harmonisation  of  the  nano  definition:  Stakeholders  urged  alignment  of  the  CPR 
definition with the Commission’s 2022 Recommendation on nanomaterials. 
Removal  of  absolute  animal  testing  reporting  obligations:  as  animal  testing  is 
banned under the CPR, stakeholders advocated for removing related data submission 
requirements, which they viewed as outdated. 
Alignment  across  relevant  EU  legislation:  There  was  a  strong  call  to  improve 
coherence  between  the  CPR  and  other  EU  acts  such  as  CLP,  REACH,  and  POP  to 
enhance clarity and legal certainty. For example, it was suggested that the annexes to 
the CPR could be updated to reflect REACH restrictions on substances used in cosmetic 
products. 
Improving  CosIng:  Stakeholders  proposed  that  the  CosIng  database  should  also 
indicate substances banned in cosmetics under the REACH or due to environmental 
concerns. 

5. 

Conclusions 

Page 92 of 109 

 
 
 
 
 
 
•  Most stakeholders agreed that the proposed changes would offer meaningful benefits 
in terms of simplification and burden reduction. However, they emphasized that any 
modifications must be carefully implemented to avoid compromising consumer safety 
or the credibility of the CPR as a benchmark for cosmetic product safety.  

•  Numerous  additional  suggestions  for  simplifying  the  CPR  were  put  forward.  These 
included:  digitalising  labelling  requirements,  establishing  rules  for  online  sales, 
streamlining  the  implementation  of  bans  or  restrictions  on  cosmetic  substances, 
removing reporting obligations related to on animal testing data, and strongly supported 
– enhancing alignment between the CPR and other key legislation, particularly, CLP 
and REACH. 

•  Stakeholders were invited to submit written contributions by 31 May 2025 (or 1 June 
at  the  latest),  especially  including  quantifiable  evidence  to  support  proposed 
simplification measures. 

•  The Commission will prepare a report based on the input received to support political 

decision-making.  

Page 93 of 109 

 
 
 
 
 
 
Opinions of the participants of the Reality Check on cosmetics collected via 
slido 

Point I of the agenda 

 Point II (a) of the agenda 

Page 94 of 109 

 
 
 
 
 
 
Point II (b) of the agenda 

Page 95 of 109 

 
 
 
 
 
 
Point II (c) of the agenda 

Page 96 of 109 

 
 
 
 
 
Point III of the agenda 

Page 97 of 109 

 
 
 
 
 
 
Point IV of the agenda 

Point V of the agenda 

Page 98 of 109 

 
 
 
 
 
 
 
ANNEX IV 

REALITY CHECK ON THE POSSIBLE SIMPLIFICATION OF CHEMICALS LEGISLATION –  
FERTILISING PRODUCTS REGULATION 
SYNOPSIS REPORT 

Meeting date: Wednesday, 7 May 2025, 15:30-17:30 

Location: Centre Albert Borschette, Brussels and online (Microsoft Teams); 

Organised  by:  European  Commission  –  Directorate-General  for  Internal  Market,  Industry, 
Entrepreneurship and SMEs, Unit F2 

Participants:  Representatives  from  the  Commission,  Member  States  authorities,  industry 
associations, and NGOs  

Number of registrants: approx. 135 

Number of participants who attended: 91 

1. 

Context and purpose of the Reality Check 

The Reality Check took place in the context of the Commission’s broader simplification strategy 
to  enhance  EU  competitiveness  through  streamlined  legislation  and,  more  specifically,  in 
preparation  of  a  proposal  for  a  Regulation  amending  certain  requirements  and  procedures  for 
chemical products. The objective was to collect feedback of stakeholders (industry, Member States 
authorities,  NGOs)  on  potential  simplification  of  Regulation  (EU)  2019/1009  (‘Fertilising 
Products Regulation’, ‘FPR’).  

The  Reality  Check  was  held  as  part  of  the  Commission  Expert  Group  meeting  on  fertilising 
products, taking place on 7 and 8 May 2025. Approx. 135 stakeholders registered for the meeting 
and 91 eventually attended. By 13 June 2025, written feedback was received from 27 stakeholders. 

The  Commission  had  uploaded  a  Concept  Note120  ahead  of  the  meeting,  presenting  some 
preliminary ideas for simplification and a set of questions to stakeholders. The feedback received 
at the meeting and in writing is summarised below. 

2. 

REACH registration of substances in EU fertilising products 

Most stakeholders confirmed that the requirement to register substances in EU fertilising products, 
regardless  of  their  tonnage,  as  a  minimum  with  the  information  requirements  for  substances 
manufactured or imported in quantities of 10 to 100 tonnes par company per year and a chemical 

120  

https://circabc.europa.eu/ui/group/36ec94c7-575b-44dc-a6e9-4ace02907f2f/library/65de137e-4755-48b0-
9c63-13baab43018c/details  

Page 99 of 109 

 
 
 
 
 
 
safety  report  covering  the  use  in  a  fertilising  product,  poses  significant  challenges  for 
manufacturers of EU fertilising products. Stakeholders explained that most substances used in EU 
fertilising products below 10 tonnes per year are manufactured by upstream suppliers. Therefore, 
the registration obligation is, in the first place, incumbent on these upstream suppliers. Whether a 
substance is registered in accordance with the FPR requirements is often not easy to find out for 
manufacturers of EU fertilising products who would like to use a certain substance. And even if 
they know that it is not, they possess limited influence to convince their suppliers to upgrade the 
registration unless the EU fertilising product use constitutes the majority of the market. Moreover, 
for considerations of confidential business information, suppliers are often reluctant to share data 
with the manufacturers of EU fertilising products, preventing those from upgrading the REACH 
registration themselves. Finally, according to business associations, some producers or importers 
of substances produced in low quantities, especially small and medium enterprises (SMEs), can 
simply not afford REACH registration in accordance with the FPR. 

As  consequences,  certain  substances  are  not  used  in  EU  fertilising  products.  Manufacturers 
alternatively market their products under national rules or in third countries, such as the US. Some 
also  replace the substance in  question by already registered but  less  effective substances. Such 
reformulation, as explained by a company, implies costly reformulation tests, stability tests and 
greenhouse tests. 

According  to  stakeholders,  the  issue  is  particularly  pertinent  for  technical  additives,  like  dyes, 
which are mostly used in very low quantities and are difficult to substitute as the performance of 
different additives varies significantly. But also, some primary components are produced and used 
in small amounts and therefore affected by this extended REACH registration requirement. 

Several stakeholders also submitted data on the costs related to the extend REACH registration 
requirement after the workshop. An industry association shared results from a survey carried out 
among their members asking about the burden of the extended REACH registration requirement 
under the FPR. Depending on tonnage band and the extent of data required, the costs reported in 
the survey for updating a registration dossier in accordance with the extended REACH registration 
requirement vary between €10 000 to €500 000 per substance. €180 000 was found as the typical 
investment needed to upgrade a registration dossier from 1-10t/y to the 10-100t/y requirements. A 
company contributing to the Reality Check reported costs in a similar range. For the six substances 
that the company registered in accordance with the extended requirements under the FPR, it spent 
between  €100 000  and  €500 000,  including  the  costs  for  data  generation,  consultancy,  dossier 
preparation and the fees paid to ECHA. It explained that, for substances below 1t/y, the FPR creates 
new costs compared to the absence of a registration obligation under REACH, while for substances 
between  1t  and  10t/y  the  registration  costs  would  be  65%  higher  for  substances  used  in  EU 
fertilising products. In the same vein, an industry association estimated that costs for upgrading a 
registration from the 1-10 tonnes to 10-100 tonnes band, excluding the fees, can result in costs of 
up to €400 000, and another industry association reported that, depending on the substance and its 
registration status (upgrading from the 1–10 t/year band to 10–100 t/year or registering an exempt 
substance in the >10 t/year band), costs range between €150 000 and €240 000. Costs in this range 

Page 100 of 109 

 
 
 
 
were also confirmed by a Member State authority, estimating a total registration cost of €270 000 
for a substance produced below one tonne per year.  

A company explained that the burden of registration is almost the same for large companies and 
SMEs, despite the more limited financial resources of SMEs. It explained that, although SMEs are 
entitled to a reduced registration fee, the effort for proving SME status would largely offset this 
reduction.  Moreover,  the  fees  represent  less  than  5%  of  total  registration  costs,  whereas  the 
preparation of the dossier and testing, which do not depend on the size of the company, represent 
the bulk of registration costs. 

According to a position paper signed by several industry associations, the costs for the extended 
REACH  registration  eventually  leads  to  increased  costs  for  manufacturers  of  EU  fertilising 
products and materialises in increased prices for users. Using several examples, they calculated 
that, by complying with the extended REACH registration requirement, the cost of a substance, 
depending on the quantity in which it is manufactured and imported and the concentration in which 
it is used in the fertilising product, increases by 40%-540%, which was confirmed in a position 
paper of another industry association and a competent authority. In one of the examples, the end 
product price would have to be increased by 26%. 

Most stakeholder were in favour of relieving the burden of extended REACH registration under 
the FPR, by applying normal  REACH,  including  the gradations according to  tonnage, to  all or 
most substances in EU fertilising products. Several stakeholders considered that for very hazardous 
substances, like persistent, bioaccumulative and toxic ones, and for certain unknown, bio-active 
substances,  and  for  inhibiting  compounds,  more  extensive  REACH  registration  might  still  be 
warranted, also considering the distinct use pattern of fertilising products, i.e. repeated application 
over large areas with direct emissions to the environment. 

3. 

Assessment of micro-organisms in plant biostimulants 

The  majority  of  stakeholders  welcomed  the  Commission’s  considerations  on  simplifying  the 
procedure for the assessment of micro-organisms (Component Material Category 7) used in plant 
biostimulants. 

Many  stakeholders  view  the  current  mechanism  for  permitting  additional  micro-organisms  or 
strains  of  micro-organisms  in  EU  fertilising  products  under  the  FPR  as  inconsistent  with  the 
demands  and  rapid  development  pace  of  the  burgeoning  plant  biostimulant  sector.  Several 
stakeholders highlighted that this process impedes market access for microbial plant biostimulants, 
discouraging innovation and investment, and delaying the availability of these products to farmers. 

According to stakeholders participating in the Reality Check, the development and availability of 
microbial plant biostimulants in the EU is crucial, not least because of the various benefits they 
bring to farmers and the environment: 

•  Enhancement  of  Nutrition  Use  Efficiency  (NUE)  and  function  as  nitrogen-fixing, 

phosphorus-solubilizing, and potassium-mobilising agents; 

Page 101 of 109 

 
 
 
 
Increasing the crops’ tolerance to abiotic stress; 
Improvement of water absorption (mycorrhizal fungi); 

• 
• 
•  Reduction of water contamination by nutrients and greenhouse gas emissions; 
•  Minimisation of soil degradation, promotion of microbial biodiversity in agricultural soils, 

and contribution to CO₂ capture from the atmosphere. 

An industry association in the plant biostimulant sector shared the results of a survey carried out 
among 65 of their members. 88% of participants said that they were not able to place their micro-
organism on the EU market because it was not yet on the positive list. When asked if they would 
apply for the FPR conformity assessment if their micro-organism was on the list, 69% responded 
affirmatively.  59%  of  respondents  are  currently  exporting  microbial  biostimulants  to  third 
countries, incl. the United States, Argentina, Mexico and Brazil, which means that their products 
produced in the EU are not provided to EU farmers.  

Industry  associations  highlighted  that  the  inability  to  market  their  biostimulants  under  EU 
legislation  compels  manufacturers  to  market  their  products  under  the  national  regulations  of 
Member States. This poses a significant burden, particularly for SMEs,  due to the considerable 
variation  in  Member  State  regulations,  the  requirement  to  obtain  approvals  in  different 
jurisdictions,  and  the  persistent  issue  of  mutual  recognition  of  authorisations  for  fertilising 
products.  Furthermore,  EU  manufacturers  may  turn  to  alternative  markets  outside  the  EU. 
Ultimately,  due  to  the  unfavourable  conditions  in  the  EU,  innovation  and  investment  in  such 
products might be redirected to third countries. 

Many stakeholders participating in the Reality Check were generally in favour of the criteria-based 
approach and of using the methodology  developed in  that study  as basis for the amendment  to 
CMC  7.  Some  stakeholders  pointed  to  certain  weaknesses  in  the  current  version  of  the 
methodology.  More  generally,  one  stakeholder  emphasised  the  importance  of  ensuring  the 
protection  of  confidential  business  information  within  this  new  criteria-based  mechanism. 
Moreover,  several  stakeholders  emphasised  the  importance  of  an  independent  assessment  of 
micro-organism, such as the European Food Safety Agency (EFSA). Two Member State authorities 
shared  their  concerns  about  the  proposal  to  let  notified  bodies  assess  the  micro-organisms  in 
accordance with the general criteria and methodology. 

4. 

Inclusion of further derived products from animal by-products  

Stakeholders  in  the  Reality  Check  confirmed  the  interest  in  the inclusion  of  additional  derived 
products from animal by-products under the FPR. Many stakeholders called for the prioritisation 
of the inclusion of derived products for which an endpoint has already been determined or which 
are currently assessed in a study carried out for the Commission. Nevertheless, some stakeholders 
also expressed interest in using animal by-products listed in Article 2(2) of Regulation (EC) No 
1069/2009. The following materials were mentioned as particularly interesting: 

•  shells from shellfish with the soft tissue and flesh removed;  

Page 102 of 109 

 
 
 
 
• 

fish sludge (i.e. faeces from farmed fish together with uneaten feed from land aquaculture 
in freshwater and from aquaculture in open sea cages (saltwater) and land- or semi land-
based facilities with saltwater); 

•  mineralised guano; 
•  plant-based soiled cat litter (i.e. waste from ‘cat toilets’). 

An  industry  association  emphasised  that  as  a  consequence  of  not  being  allowed  to  use  certain 
derived products in EU fertilising products manufacturers are forced to use other more expensive 
material.  In  addition,  circular  business  models  and  progress  on  soil  health  and  organic  matter 
restoration would be hampered, which might indirectly impact the yields and resilience of crops. 
Another stakeholder pointed out that the use of such materials would not only entail economic 
benefits  for  manufacturers  of  EU  fertilising  products  but  also  enable  the  recovery  of  valuable 
materials  that  would  otherwise  be  classified  as  waste.  Concretely  regarding  fish  sludge,  a 
stakeholder  noted  the  material's  potential  to  become  a  significant  phosphorus  source  within  a 
circular economy, potentially substituting some mined phosphorus in fertilisers. Regarding shells, 
a competent authority clarified that their disposal poses a challenge for small companies producing 
canned  mussels,  which  are  economically  vital  to  coastal  villages.  Concerning  cat  litter,  a 
stakeholder explained that the reuse in EU fertilising products would not only reduce the volume 
of municipal solid waste, but also ensure that the plant-based component of the soil and the cat 
excrements are introduced into soil, providing nutrients and increasing soil organic matter. 

5. 

Digitalisation  

Although  digitalisation  of  reporting  requirements  under  the  FPR  did  not  seem  to  be  the  most 
relevant concern of stakeholders at the Reality Check, several stakeholders, including industry and 
authorities,  underlined  in  their  written  submissions  that  the  digitalisation  of  information 
requirements  can  reduce the administrative burden for  companies  and authorities,  as  electronic 
management  can  facilitate  the  exchange,  storage  and  access  to  information,  reduce  errors 
associated with manual processes, and minimise paper usage and the costs linked to the handling 
of paper documents.  

Some concerns were expressed in  relation  to  cyber security, availability and interoperability of 
digital infrastructure, costs for acquiring necessary technology and, in relation to exports, paper-
based systems in third countries. Several  stakeholders pointed out that industry and  authorities 
would need 2-3 years to adjust to the new digital requirements, while one suggested 1-2 years. 

6.  Other ideas for simplification 

Stakeholders  had  many  additional  ideas  for  simplification,  which  they  submitted  after  the 
workshop, including: 

Page 103 of 109 

 
 
 
 
•  An industry association suggested making  several  clarifications, currently addressed in 

the Commission’s FAQ document121, in the legal text.  

•  Several industry stakeholders advocated for moving away from an individual assessment 
of  materials  to  be  added  to  the  different  component  material  categories  (CMCs)  to  a 
criteria-based approach for all CMCs, or at least for derived products from animal by-
products (CMC 10).  

•  Some industry stakeholders suggested changes to the rules on digital labelling introduced 
in  2024122,  including  alignment  with  CLP  and  extension  of  information  which  can  be 
provided in the digital label only, without duplication on a physical label.  

•  Some industry stakeholders pointed to unclarities or coherence issues between the FPR 
and  other  relevant  legislation,  notably  the ABPR,  REACH  and  the Waste  Framework 
Directive (Directive 2008/98/EC)123.  

•  Several industry stakeholders asked the Commission to clarify that component materials 
may contain detectable traces of impurities and unintended substances which are not 
considered component materials.  

•  A Member State authority proposed to establish a negative list of compounds not to be 
used in  EU  fertilising products  similar to  the list  in Annex III to  Regulation (EC) No 
1107/2009 on plant protection products124.  
•  A  Member  State  authority  suggested 

the  revision  of  the  Information  and 
Communication  System  on  Market  Surveillance  (ICSMS)  to  better  account  for  the 
specificities of the fertilising products sector.  

•  Some  stakeholders  called  for  allowing  more  types  of  sludge  to  be  used  as  input  for 

component materials.  

•  A  representative  from  a  European  Standardisation  Organisation  (ESO)  suggested 
removing  the  step  of  an  assessment  by  a  consultant  (‘HAS  assessment’)  after  the 
publication of  the European standard by the ESO and before the citation in  the  Official 
Journal.  

Conclusions 

7. 
•  Applying  ‘standard’  REACH  registration  requirements  to  substances  in  EU  fertilising 
products would remove an important obstacle for the EU fertilising products industry in 
using certain substances, thereby reducing costs for reformulation and ensuring the use of 

121  
122  

123  

124  

https://ec.europa.eu/docsroom/documents/63434.  
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).  
Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and 
repealing certain Directives (OJ L 312, 22.11.2008, p. 3, ELI: http://data.europa.eu/eli/dir/2008/98/oj). 
Regulation  (EC)  No 1107/2009  of  the  European  Parliament  and  of  the  Council  of  21 October  2009 
concerning  the  placing  of  plant  protection  products  on  the  market  and  repealing  Council  Directives 
79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1, ELI: http://data.europa.eu/eli/reg/2009/1107/oj).  

Page 104 of 109 

 
 
 
 
 
 
the  most  suitable  substances,  and  would  encourage  manufacturers  to  obtain  the  CE 
marking. 

•  A  simplified  procedure  for  the  assessment  for  micro-organisms  is  needed  to  ensure 
innovation  and  investments  in  microbial  plant  biostimulants  in  the  EU  and  ensure  the 
availability of these products to EU farmers. An assessment by manufacturers and notified 
bodies in accordance with general safety and efficiency criteria and a methodology, which 
could be based on the methodology developed in the ongoing study, seems to be a viable 
solution.  

•  Multiple suggestions were made for further simplification of the FPR, some of them going 
beyond  this  very  targeted  simplification  exercise.  Some  aspects  could  be  further 
investigated in the context of the ongoing FPR evaluation. Other suggestions could also be 
implemented, independently from the envisaged legislative proposal, via a delegated act. 
•  Any legislative proposal will be subject to standard co-legislative procedures, including 

Council and Parliament review. 

Page 105 of 109 

 
 
 
 
 
 
 
 
 
 
ANNEX V 

DETAILS ON THE COSTS AND SAVINGS ANALYSIS  
FOR THE CHANGES TO EXTENDED  
REACH REGISTRATION REQUIREMENTS FOR FPR 

Baseline: 

1.  Substances  falling  under  the  Component  Material  Category  1  –  Virgin  substances  and 
mixtures and  substances and  additives used under other Component Material Categories 
must have been registered with a REACH registration dossier in line with, at a minimum, 
the requirements set in Annexes VI to VIII (tonnage band 10-100t per year) and containing 
a chemical safety report demonstrating safe use in a fertilising product. 

2.  Manufacturers of fertilising products, or manufacturers of substances used in a fertilising 
product (at the request of manufacturers of fertilising products), currently need to prepare 
or update a REACH registration dossier to comply with the FPR’s requirement, if they want 
a substance to be used in an EU fertilising products. This implies the generation of more 
data and the development or update of the chemical safety assessment showing safe use in 
a fertilising product. In addition, they have to pay a fee to the European Chemicals Agency 
(ECHA) for the new registration or the update.  

3.  As a consequence of the current difficulty to ensure that all substances used in the fertilising 
products are registered in accordance with the FPR, some fertilising products may be placed 
only on one or several national markets according to national rules. For placing the product 
on the market in other Member States, manufacturers need to ensure compliance with that 
State’s legislation or rely on mutual recognition. In the Impact Assessment accompanying 
Commission’s proposal for FPR, costs for national registrations up to €50 000 per product 
per Member State were reported. Moreover, two cases studies showed adaptation costs for 
manufacturers seeking mutual recognition, incl. adaptation of their products, labels and/or 
packaging, of €15 000 and €47 000125. 

Evaluation of the proposed changes to revert to generic rules in REACH 

1.  The analysis of the reversal from the current extended REACH requirements under FPR to 
generic REACH requirements can be based on the evaluation of the additional costs of the 
substances registered under REACH or not, according to a tonnage band below or equal to 
10-100 t/year, with or without a chemical safety report. The identified additional cost would 
be theoretical savings for companies using those substances as ingredients in their fertilising 
products. 

2.  Identification of the  average update  cost:  Based  on data provided by stakeholders in  the 
context of the Reality Check, depending on tonnage band and the extent of data required, 
the  costs  for  updating  a  registration  dossier  in  accordance  with  the  extended  REACH 

125  

SWD(2016) 64 final. 

Page 106 of 109 

 
 
 
 
 
registration requirement under the FPR vary between €10 000 to €500 000 per substance. 
In  a  survey  carried  out  by  an  industry  association  among  their  members,  €180 000  was 
found as the typical investment needed to upgrade a registration dossier from 1-10t/y to the 
10-100t/y requirements. This can be taken as a proxy for the average cost for compliance 
with the extended REACH registration requirement. 

3.  Identification of relevant substances for use as ingredients in fertilising products: Data from 
ECHA’s public database on the substances currently registered for the use in a fertilising 
product,  but  not  in  accordance  with  FPR’s  extended  REACH  registration  requirement, 
illustrates to what extent this requirement poses an obstacle for the Single Market access of 
fertilising products. 

4.  REACH  registration  dossiers  of  substances  contain  information  about  the  uses  and  the 
sectors of uses. On that basis, the following numbers were extracted from ECHA’s public 
database  to  provide  an  indication  on  the  number  of  substances  registered  for  use  in  a 
fertilising  product.  However,  the  quality,  including  comprehensiveness,  could  not  be 
ascertained, especially because, while some substances are direct component materials of 
fertilising  products,  other  are  used  as  raw  materials  to  product  component  materials  for 
fertilising products. Therefore, substances either with described use as a fertiliser (product 
category  12  –  PC12)  or  with  described  sector  of  use  in  agriculture,  forestry  and  fishing 
(sector of use 1 – SU1) were included. 

Table : Number of substances relevant as potential component materials for CE-marked fertilising products but not yet registered 
in line with FPR requirements 

Substances 
registered 
with  uses  as 
fertilisers 
(PC12) 

Substances registered with 
uses  as  fertilisers  (PC12) 
and 
the  sector  of 
agriculture,  forestry  and 
fishing (SU1) 

in 

30 (15)* 

17 (12) 

Substances 
registered with 
the 
uses 
in 
sector 
of 
agriculture, 
forestry 
fishing (SU1) 
26 (17) 

and 

Total  substances  of 
interest 
potential 
(PC2 ∪ SU1) 

39 (20) 

83 (25) 

44 (14) 

76 (19) 

115 (30) 

113 (40) 

61 (26) 

102 (36) 

154 (50) 

to 

Substances 
registered 
the 
range  0  to  10t  per 
year 
Substances 
registered 
the 
range  1  to  10t  per 
year 
Total 

to 

*Figures between brackets report the number of substances for which a chemical safety assessment is available,  indicating that 
much testing has already been undertaken and possibly more data is already available. Accordingly, a lower cost for update may 
be possible. 

5.  Cost calculations: The update of the registration dossier of substances for which a chemical 
safety report is available would be cheaper (estimated at €10 000 per substance) than for a 

Page 107 of 109 

 
 
 
 
 
 
full  update  in  case  no  chemical  safety  report  available  (estimated  between  €10 000  and 
€500 000, average: €180 000). 

Table : Costs incurred for REACH registration if substance were to be used in an EU fertilising product 

Reported cost per 
registration update 
from 1 to 10T per 
year 
Number of substances 
of potential interest 
One-off costs from 
updating existing 
REACH registration 
dossiers for all 
substances of 
potential interest  
Annualised one-off 
costs126  

Lower 
€10 000 

Average 
€180 000 

High 
€500 000 

154, out of which 50 already have a CSA 

€1 540 000 
(50 * 10 000 + 104 * 
10 000) 

€19 220 000 
(50 * 10 000 + 104 * 
180 000) 

€52 500 000 
(50 * 10 000 + 104 * 
500 000) 

€181 000 

€1 292 000 

€3 529 000 

Estimated savings following the envisaged amendment:  

1.  The FPR would no longer require an extended REACH registration. Manufacturers could 
place their products on the EU market as CE-marked fertilising products, relying on the 
current registration without the creation or update of a registration dossier (assuming that 
there would be no increase in the quantity of the substance placed on the market in the EU, 
or a limited one, with no jump to a higher tonnage band). The 154 substances identified as 
potentially interesting for the use in EU fertilising products could be used without the one-
off cost of about €19 220 000 (with a range between €1 540 000 and €52 500 000). 

2.  Manufacturers which would CE-mark their products to place them on the Single Market, 
would  no  longer  face  multiple  fees  for  national  registrations  and  save  adaptation  costs. 
Assuming that they place their product on the market in five Member States and costs for 
registration and adaptation  in  accordance with  national  rules  at  the higher end, this can 
result in cost savings of between €15 000 and €43 000 per product and national market. As 
no information is available on the number of concerned products, savings from moving to 
national rules and mutual recognition to the Single Market cannot be estimated. 

3.  Therefore, the savings for the fertilising industry from reversing to generic REACH 
rules can be estimated in a conservative way to amount to €19 220 000 or €1 290 000 
when annualised in present value. 

126  

The conversion to annualised present value is based on 3% discount rate and a period of 10 years. 

Page 108 of 109