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
Date: 2019-06-25
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: application of EU law, chemical product, chemicals legislation, dangerous substance, environmental protection, health risk, industrial hazard, labelling, occupational safety, regulatory policy

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 25.6.2019  COM(2019) 264 final  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 final}  
 
 
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 

INTRODUCTION 

Reflecting the increasing role that chemicals play in our society and economy and illustrating 
the  continuous  commitment  to  ensuring  a  high  level  of  protection  of  human  health  and  the 
environment, as well as ensuring the free movement of chemicals on the internal market, the 
EU  chemicals  legislation  has  evolved  and  expanded  significantly  since  the  adoption  of  the 
first chemicals related directive in the late 1960s. It now regulates both the chemical sector as 
well  as  related  downstream  industries  that  use  chemicals.  It  covers  the  full  lifecycle  of 
products manufactured in or imported into Europe and the protection of the environment and 
human health from chemical hazards and risks.  
The Commission initiated a Fitness Check of chemicals legislation other than REACH1 ('the 
Fitness Check') in 20152, to see whether the legislation was fit for purpose and delivered as 
intended.  This  Fitness  Check  has  assessed  over  40  pieces  of  legislation3  that  cover  a  great 
part  of  the  EU  chemicals  acquis,  focusing  on  the  chemical  hazard  and  risk  assessment  and 
risk management requirements, procedures and processes in the legislation under its scope. It 
is  part  of  the  European  Commission's  Regulatory  Fitness  and  Performance  programme 
(REFIT)4. 
The  REACH  Regulation5,  the  pharmaceutical6,  veterinary7  and  food  additives8  legislation 
were excluded from the scope of this Fitness Check.9   

1  Regulation  (EC)  No  1907/2006  of  the  European  Parliament  and  of  the  Council  of  18  December  2006 
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a 
European  Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council  Regulation  (EEC)  No 
793/93  and  Commission  Regulation  (EC)  No  1488/94  as  well  as  Council  Directive  76/769/EEC  and 
Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC 
2 http://ec.europa.eu/smart-regulation/roadmaps/docs/2015_grow_050_refit_chemicals_outside_reach_en.pdf  
3  See  Annex  4  of  the  Commission's  Staff  Working  Document  on  the  Fitness  Check  of  the  most  relevant 
chemicals  legislation  (excluding  REACH)  as  well  as  related  aspect  of  legislation  applied  to  downstream 
industries.  
4 COM(2012) 746 final  
5  Except  its  Annex  XIII  laying  out  identification  criteria  for  persistent,  bioaccumulative,  toxic  and  very 
persistent and very bioaccumulative substances. Findings of the second REACH evaluation are presentend in the 
‘Commission  General  Report  on  the  operation  of  REACH  and  review  of  certain  elements’  (COM(2018)  116 
final) and its accompanying Staff Working Documents (SWD(2018) 58 final).  
6 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community 
code relating to medicinal products for human use  
7 Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community 
code relating to veterinary medicinal products 

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The  complexity  and  far-reaching  effects  of  the  EU  chemicals  legislation  combined  with 
certain data and evidence gaps made the exercise challenging. Notable efforts were made to 
collect data and evidence via a number of studies and reports10. The findings of this Fitness 
Check  have  also  been  informed  by  a  number  of  consultation  activities  such  as  public  and 
two  Eurobarometer  surveys.11  They  were 
targeted  stakeholder  consultations  and 
complemented  and  took  into  consideration  other  chemicals  related  initiatives12  and  the 
information and data from recently or nearly-completed evaluations13.   

The assessment provides a comprehensive presentation of how the various pieces of the EU 
chemicals legislation fit together and what the strengths and weaknesses are. It also takes into 
account  a  number  of  stakeholders’  concerns  expressed  during  the  consultation  activities. 
Moreover, the evidence and data collected as part of this Fitness Check will set a baseline and 
will constitute a point of reference for future assessments of the EU chemicals legislation. 

This  Report  presents  the  main  findings  and  sets  the  basis  for  further  discussion  with 
stakeholders on how to unlock the full potential of the EU chemicals legislation to deliver a 
Europe that protects.  

1.  THE EU CHEMICALS LEGISLATION: 50 YEARS OF CONTINUOUS PROGRESS 

The  more  than  40  pieces  of  legislation  that  were  assessed  for  the  purposes  of  this  Fitness 
Check have evolved into a solid framework that reflects 50 years of continuous efforts and 
progress. These pieces of legislation cover the whole value chain and the full  lifecycle, i.e. 
from the moment chemicals are produced to when they are used and after their release into 
the  environment.  Regulated  aspects  include  data  gathering,  data  generation  and  testing, 
chemical  hazard  identification  and  classification,  labelling,  risk  assessment  and  risk 
management. 

The EU chemicals legislation: state of play  

8 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food 
additives 
9  The  pharmaceuticals,  veterinary  and  food  additives  legislation  was  excluded  from  the  scope  of  this  Fitness 
Check because their hazard and risk assessment is based on different considerations (i.e. an assessment of the 
risk trade-offs between the health benefits of the medical product versus potential undesired side-effects). For 
example,  under  the  Medicinal  Products  for  Human  Use  Directive  (2001/83/EC)  the  primary  objective  is  to 
safeguard  public  health  i.e.  treat  or  prevent  disease  in  human  beings,  restor,  correct  or  modify  physiological 
functions or make a medical diagnosis.  
10 See Annex 3 of the accompanying Commission's Staff Working Document. 
11 See Annex 2 of the accompanying Commission's Staff Working Document 
12  Communication  on  options  to  address  the  interface  between  chemical,  product  and  waste  legislation 
(COM(2018)  32  final);  Communication  on  the  operation  of  REACH  and  review  of  certain  elements 
(COM(2018)  116  final);  ‘Towards  a  comprehensive  European  Union  framework  on  endocrine  disruptors’ 
(COM(2018)  734  final);  ‘European  Union  Strategic  approach  to  Pharmaceuticals  in  the  Environment’ 
(COM(2019) 128 final)  
13 REFIT Evaluation of the EU legislation on plant protection products and pesticides residues; Fitness Check of 
Reporting and Monitoring of EU Environment Policy; Evaluation of Regulation (EC) No 648/2004 (Detergents 
Regulation);  the  General  Food  Law  Fitness  Check;  REFIT  evaluation  of  the  European  Union  occupational 
safety and health Directives. Please refer to Annex 4 Table 3 to see how different sources of information were 
used for the purposes of this Fitness Check.    

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The  first  piece  of  the  EU  chemicals  legislation,  the  Dangerous  Substances  Directive14,  was 
adopted  in  1967  to  protect  public  health,  in  particular  the  health  of  workers  handling 
dangerous  substances.  Because  differences  in  national  provisions  in  a  Europe  of  Six  were 
hindering trade and, thus, directly affecting the establishment and functioning of the common 
market, measures were taken to introduce Community-wide provisions on the classification, 
packaging  and  labelling  of  dangerous  substances.  Since  then,  the  Dangerous  Substances 
Directive has been amended and replaced by the Regulation on Classification, Labelling and 
Packaging of substances and mixtures15 (the CLP Regulation), and other pieces of legislation 
have been progressively adopted to regulate hazardous chemicals in water, waste, fertilizers, 
pesticides, industrial activities, consumer products and occupational settings. In parallel, the 
EU  engaged  in  international  processes  aiming  at  regulating  hazardous  chemicals  of  the 
highest concern.16 

Improvements  to  the  EU  chemicals  legislation  reflect  the  need  to  overcome  many  global, 
economic, societal and environmental challenges.  These  have shaped the  ambition  of today 
and have been translated into a series of new objectives that the EU has committed to, such as 
the United Nations’ 2030 Agenda for Sustainable Development17, or set for itself such as the 
action plan for the Circular Economy18 and the strategy for a renewed EU Industrial Policy19. 
By  doing  so,  the  EU  has  become  a  global  frontrunner  on  many  aspects.  Its  chemicals 

14 Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative 
provisions relating to the classification, packaging and labelling of dangerous substances 
15  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 
16 For example, the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and the 
Basel, Minamata, Rotterdam, and Stockholm Conventions as well as the Convention for the Protection of the 
Marine Environment of the North-East Atlantic (OSPAR) 
17 In particular SDGs 3.9, 6.3, 12.4 
18 COM(2015) 614 final 
19 COM(2017) 479 final 

3 

Second generation EU chemicals legislation19671970s1980s1990s2000-2019Pre-CLP legislationDetergentsWorkers' safetyVulnerable workers'  safetyRecast and repeals of the pre-existing legislationWaste Industrial emissionsGeneral product safetyCodification and framework approach to water and wasteWaterToys BiocidesCLPPre-REACH DirectiveProtection of animals used for scientific purposesPre-REACH RegulationREACHCosmeticsFertilizersFirst-generation EU chemicals legislationPlant protection products Food contact materials Pesticide residues  
 
 
                                                 
legislation has become a benchmark for the development of chemical risk management rules, 
at  the  international  level  as  well  as  in  other  countries  and  regions.  Where  the  EU  acts  on 
restricting the use of hazardous chemicals, other countries and regions often follow20. 

Different EU policy interventions in the chemicals area demonstrate the EU’s commitment to 
protecting its citizens and the environment and, at the same time, to preserving the internal 
market  which  delivers  for  consumers  and  where  EU  business  can  thrive.  EU  citizens  have 
much  greater  confidence  in  the  chemical  safety  of  products  manufactured  in  the  EU 
compared to those imported21.   

Significant  investments  have  gone  into  the  EU-level  risk  assessment  capacity  benefitting 
directly or indirectly many pieces of legislation within the scope of this Fitness Check. The 
EU contribution from its general budget to the European Chemicals Agency (ECHA) and the 
European Food Safety Authority (EFSA) amounted in 2017 to EUR 150 million.22 The EU 
has also contributed to improving non-animal testing methods by providing more than EUR 
650 million since 2000 to research and development23
 and EUR 7 million to the operation of 
the European Union Reference Laboratory for alternatives to animal testing.24 Different EU 
funding  programmes  such  as  Horizon  202025,  LIFE26  and  COSME27  have  also  supported 
innovation in the chemicals area, notably on safe and sustainable chemistry.  

2.  AN OVERALL FIT-FOR-PURPOSE FRAMEWORK OF EU CHEMICALS LEGISLATION  

This Fitness Check has assessed whether the EU chemicals legislation meets its objectives in 
terms of risk and hazard assessment and management of hazardous chemicals, and if it does 
so  in  a  coherent  and  efficient  way.  It  concludes  that,  overall,  the  EU  chemicals  legislation 
delivered  results  as  intended  and  is  fit-for-purpose.  However,  it also identifies  a  number  of 
important  issues  and  weaknesses  that  are  holding  the  EU  chemicals  legislation  back  from 
delivering its full potential and which limits its ability to achieve its objectives and to be fit-
for-purpose.  

The  assessment  carried  out  for  the  purposes  of  this  Fitness  Check  focused  on  the  chemical 
hazard and risk assessment and risk management processes specified by the different pieces 

20 Study on the cumulative health and environmental benefits of chemicals legislation p. 324 
21 Special Eurobarometer 456 
22 In spite of being out of the scope of this Fitness Check, this figure includes the EU contribution to ECHA for 
the operation of REACH Regulation as well as that for other pieces of legislation that EFSA is in charge of and 
which are not covered by this Fitness Check.  
23 Funding came from the 7th as well as the 8th EU Framework Programme for Research and Development, with 
an annual avarege of EUR 35 million. 
24 This figure includes the REACH Regulation that is not covered by this Fitness Check.  
25  See  for  example  European  Human  Biomonitoring  Initiative  (HBM4EU).  The  EU  contribution  amounts  to 
around EUR 50 million. https://cordis.europa.eu/project/rcn/207219_en.html  
26 During the 2014-2016 period LIFE contribution to several projects in chemicals area amounted around EUR 5 
million.  See  for  example  the  following  projects:  FLAREX,  VERMEER,  MATHER,  COMBASE,  CHEREE, 
EXTRUCLEAN  
27  A  project  aiming  at  facilitating  contacts  between  solutions  providers  and  SMEs  interested  in  substituting 
chemical substances of potential concern. The second phase of the project was launched in 2019. 

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of legislation considered. The REACH Regulation, as well as the pharmaceutical, veterinary 
products,  and  food  additives  legislation  were  excluded  from  its  scope.  This  presented  a 
number of challenges, particularly in terms of disentangling estimates of costs and benefits as 
REACH  is  often  an  integral  part  of  the  policy  mix  that  is  responsible  for  the  costs  and 
benefits of reducing the exposure to hazardous chemicals. 

The Fitness Check looked at the pieces of legislation directly regulating chemical substances 
and mixtures as well as those regulating conditions under which chemicals are manufactured, 
treated or used (e.g. occupational health and safety or environmental legislation) or regulating 
products, which are manufactured using chemicals (e.g. toys and food contact materials) or 
the impacts of chemicals in certain environmental compartments (e.g. water and marine). 

EU approach to risk assessment and risk management  

The  human  health  and  environmental  risks  from  the  exposure  to  hazardous  chemicals  are 
addressed  via  hazard  and  risk  assessment  procedures  prescribed  in  the  EU  chemicals 
legislation.  The  main  steps  of  the  chemicals  risk  assessment  and  management  process  (i.e. 
decision making and implementation and enforcement) usually involve: 

Hazard 
identification 
and 
classification 

Exposure 
assessment 

Dose-response 
assessment 

Risk 
characterisation 

Risk 
management 
decision 

Implementation and enforcement 

The CLP Regulation is one of the cornerstones of the EU chemicals legislation. It deals with 
the hazard identification, assessment and classification of chemicals and the communication 
of  those  hazards  to  consumers  and  workers.  For  their  risk  management,  several  product-
specific  pieces  of  legislation  refer  to  the  CLP  Regulation  (e.g.  cosmetics,  detergents, 
biocides, plant protection products) using its chemical hazard classification criteria. The CLP 
is  the  EU  implementation  of  the  UN  Globally  Harmonised  System  of  Classification  and 
Labelling  of  Chemicals  (GHS)28.  In  addition  to  the  hazard  classification  under  the  CLP 
Regulation, other pieces of legislation may foresee additional hazard categories.  

The  ECHA,  EFSA  and  the  European  Medicines  Agency  (EMA),  and  two  EU  scientific 
committees29  are  responsible  for  providing  the  decision  makers  with  scientific  advice  on 
hazard and risk assessment. Risk management measures – which can be policy-based and/or 
technical  in  nature  -  are  then  decided  by  the  Commission  in  light  of  the  identified  hazards 
and/or risks. 

28 http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html 
29  The  Scientific  Committee  on  Consumer  Safety  (SCCS)  ,  the  Scientific  Committee  on  Health,  Environment 
and  Emerging  Risks  (SCHEER)  and,  previously,  the  Scientific  Committee  on  Occupational  Exposure  Limits 
(SCOEL),  whose  competences  in  terms  occupational  exposure  to  hazardous  chemicals  have  been  transferred 
since 2019 to the Risk Assessment Committee (RAC) of ECHA. 

5 

  
 
 
                                                 
 
Depending  on  the  nature  and  the  dimension  of  hazards  and  on  the  exposure  situations 
involved,  risk  management  measures  are  taken  directly  based  on  the  identified  hazard 
classification  (generic  risk  consideration)  or  based  on  a  specific  risk  assessment.  In  most 
cases, the EU chemicals legislation uses a combination of both of these approaches.  

The  linkages  between  the  different  pieces  of  EU  chemicals  legislation  are  generally  well-
established  and  functioning  reasonably  well.  The  EU  legal  framework  on  chemicals  is 
generally designed to make science- and evidence-based decisions. The approach allows it to 
deliver in an effective, efficient and coherent way. The added value of policy action at the EU 
level is high and remains relevant.  

While  the  overall  regulatory  costs  of  the  EU  chemicals  legislation  for  the  EU  industry  are 
estimated  to  be  several  billion  euro  per  year,  the  EU  chemicals  legislation  has  also  led  to 
significant  benefits  in  terms  of  avoided  health  and  environmental  impacts  (e.g.  healthcare 
costs, productivity losses, suffering and premature deaths, remediation costs, and degradation 
of  environmental/eco-system  services).  The  quality  and  the  availability  of  data  needed  to 
perform robust risk assessments and to make sound risk management decisions has improved 
considerably in recent years. Also, the EU’s knowledge base on chemical hazards and risks 
has become a world-class asset and continues to grow and improve. Much of this reflects the 
shift  of responsibility  from EU and  Member State authorities to  industry for generating the 
necessary data for hazard and risk assessments and the significant investment of resources in 
the establishment of recognised and independent EU agencies.   

3.  IDENTIFIED CHALLENGES, GAPS AND WEAKNESSES 

The  Fitness  Check  has  identified  a  number  of  challenges,  gaps  and  weaknesses.  Some  of 
these  relate  to  specific  pieces  of  legislation.  However,  in  line  with  the  broad  focus  of  the 
Fitness  Check,  the  following  sections  present  only  those  findings  that  affect  the  correct 
functioning of the legislation from a framework and a more general perspective and that are 
holding it back from delivering its full potential.  

3.1. IMPLEMENTATION AND ENFORCEMENT  

The correct functioning of the EU chemicals legislation relies heavily on the availability of 
the  resources  of  public  authorities  in  charge  of  its  implementation  and  enforcement. 
However, cutbacks in, and variations between, the capacity, available resources and expertise 
of  Member  States  competent  authorities  are  presenting  some  significant  challenges  for  the 
implementation  and  the  enforcement  of  the  EU  chemicals  legislation  and  its  overall 
effectiveness and efficiency. A number of stakeholders, for instance, have expressed concerns 
with respect to the pace of the harmonised classification processes in contrast to the processes 
of  self-classification  by  industry30.  Classification  enables  adequate  risk  management 
throughout the EU and also has certain links with the approval process of active substances 
used  in  plant  protection  and  biocidal  products.  The  Member  States’  capacity  to  prepare 
harmonised classification dossiers is limited, in particular following the 2008 financial crisis. 

30  The  CLP  Regulation  requires  industry  to  ‘self-classify’  all  substances  placed  on  the  market  irrespective  of 
tonnage.  For  hazards  of  highest  concern  (carcinogenicity,  mutagenicity,  reproductive  toxicity  (CMRs)  and 
respiratory sensitisers) and for other substances on a case-by-case basis, classification and labelling should be 
harmonised  throughout  the  EU  in  which  case  the  Member  States  need  to  agree  on  the  classification  of  a 
substance.  

6 

  
 
                                                 
Moreover, the workload is unevenly spread between Member States’ competent authorities, 
with just a few Member States carrying the majority of the burden.  

Resource  constraints  at  national  level  affect  the  capacity  to  carry  out  different  enforcement 
activities,  such  as  inspections  and  other  controls  including  market  surveillance  activities  or 
reporting.  These  constraints  together  with  differences  in  the  level  of  implementation  and 
enforcement from one Member State to another lead to an inconsistent application of the EU 
law. This can create mistrust amongst Member States, leading to undermining the application 
of  the  principle  of  mutual  recognition  with  ultimately  negative  consequences  on  the  free 
movement of goods within the EU.  

There is also a considerable lack of information on the level of compliance with the existing 
EU  chemicals  legislation,  particularly  with  respect  to  consumer  products.  The  EU  Rapid 
Alert  System  for  dangerous  non-food  products  (RAPEX)  and  the  Rapid  Alert  System  for 
Food  and  Feed  (RASFF)  are  efficient  and  useful  tools  for  exchange  of  information  and 
measures taken on products posing a serious risk to health or the environment. However, the 
risk  identified  may  not  be  due  to  a  lack  of  compliance.  Moreover,  non-compliant  products 
which  do  not  represent  a  serious  risk  are  not  notified  through  RAPEX  or  RASFF. 
Consequently  these  two  alert  systems  can  only  provide  a  partial  picture  about  the  overall 
level of compliance of products placed on the EU market. Moreover, articles imported into 
the  EU,  including  via  online  sales31,  still  represent  a  particular  challenge  for  market 
surveillance  authorities  for  ensuring  both  overall  consumer  protection  as  well  as  fair 
competition.  

Understanding  and  keeping  up-to-date  with  changes  in  legal  requirements  is  more 
challenging  for  SMEs  compared  to  bigger  companies.  The  level  of  compliance  with  the 
existing  rules  also  depends  on  the  clarity  of  the  rules  so  that  actors  understand  their  legal 
obligations.  The  current  lack  of  clarity  with  respect  to  how  to  apply  the  ‘CLP  bridging 
principles  method’32  is  a  case  in  point.  From  a  Member  State  and  industry  association 
perspective, it can be challenging to reach small companies, and notable differences exist in 
the  level  of  support  that  Member  States  provide  to  SMEs  helping  them  to  understand  and 
comply with the EU chemicals legislation. 

3.2. DUPLICATION, BURDENS AND PACE OF PROCEDURES 

Currently, scientific advice and risk assessment are provided to the Commission by different 
agencies  and  scientific  committees.  Their  areas  of  intervention  and  their  competencies  are 

31  With  regard  in  particular  to  online  sales,  the  Commission  has  recently  taken  several  initiatives  involving 
market  surveillance  authorities  (through  the  organisation  since  2017  of  yearly  “e-enforcement  academies”  for 
improving  online  surveillance),  consumers  (with  information  campaigns  on  safe  online  shopping)  and  online 
economic  operators  (involving  them  in  active  fulfilment  of  their  obligation  thanks  to  the  signature  of  the 
‘Product Safety Pledge’ with key online sells platforms).  
32  The  ‘bridging  principle  method’  is  a  method  applied  when  a  mixture  has  not  been  tested  to  determine  its 
hazardous properties, but there is sufficient data on similar tested mixtures and individual hazardous ingredients 
to adequately characterise the hazards of the mixture. In the case of detergents for example this method allows 
to avoid over-classification which may result from applying the calculation method usually preferred by smaller 
companies due to cost considerations. The lack of clarity with respect to how to apply the bridging principles 
hampers the effectiveness of the method and also leads to discrepancies in the interpretation and acceptance of 
the classification by Member States.  

7 

  
 
                                                 
determined  in  the  relevant  pieces  of  legislation.  The  rules  of  procedure  governing  the 
functioning  of  the  existing  committees  explicitly  recognise  the  need  to  ensure  good  and 
effective cooperation among them and with the relevant EU agencies. However, the strength 
of  the  obligation  to  seek  convergence  varies.  While  the  delineation  of  their  tasks  and 
competencies is often clear, there are areas of potential overlap (e.g. toys, detergents or other 
consumer  goods,  nanomaterials).  This  means  that  the  same  substance  can  be  assessed  by 
ECHA  or  by  one  of  the  EU  scientific  committees,  depending  on  which  legislation  applies, 
and  possibly  lead  to  diverging  opinions.  The  Commission  has  already  started  to  work  on 
streamlining  the  hazard/risk  assessment  by  ECHA  and  EFSA  to  better  ensure  the 
convergence  of  conclusions.  There  are  additional  opportunities  for  simplifying  the  current 
set-up  and  streamlining  the  risk  assessment  processes  among  all  relevant  EU  assessment 
bodies.  This  could  make  the  functioning  of  the  chemicals  legislation  more  efficient  (e.g. 
avoiding  duplication  of  efforts)  and  more  predictable  (e.g.  reducing  the  risk  of  potentially 
diverging outcomes of hazard/risk assessments at EU level). This could also reduce the need 
to provide information to multiple interlocutors and ensure that all relevant stakeholders are 
actively involved.  

Some  duplication  of  efforts  may  also  occur  in  data  generation  because  of  the  lack  of 
awareness  of  interested  parties  of  what  information  is  available  and  where  and  how  the 
existing data can be used. Problems in data sharing across institutions and legislation are also 
encountered  because  of  insufficient  cooperation  but  also  because  of  the  sometimes  too 
restrictive  access  and  re-use  rights.  This  duplication  can  generate  extra  costs,  as  well  as 
longer-than-necessary timeframes, and, ultimately, negatively affect the level of protection as 
well  as  competitiveness  and  access  to  the  market,  in  particular  for  SMEs.  These  negative 
impacts  risk  to  be  exacerbated  in  the  future  given  that  the  wealth  of  information  on 
substances  and  their  hazardous  properties  is  expected  to  increase.  For  example,  the  shift 
towards  a  more  circular  economy  will  require  tracking  substances  in  articles  and  waste 
streams, which will naturally generate more data. At the same time, an increasing amount of 
information  and  data  is  being  generated  via  current  and  future  human  and  environmental 
monitoring. A more comprehensive approach across the EU chemicals legislation, including 
through an open data policy and a better use of smart technologies, could improve the overall 
efficiency  of  the  EU  legal  framework  for  chemicals  and  contribute  to  the  Commission’s 
commitment towards more transparency33.  
The current substance-by-substance approach34 used in hazard and risk assessment processes 
is generally effective in identifying the hazards of a specific substance and the risks from the 
situation in which it is used. Nevertheless, given the high number of substances that need to 
be assessed and the resources and the time that such an assessment requires, this approach has 
its  limits  in  terms  of  the  overall  efficiency.  During  the  consultation,  stakeholders  from  all 
categories have highlighted the need for greater flexibility and a more integrated and holistic 
view in assessing chemicals with similar hazard, risk or function as a group. This could result 
in  considerable  efficiency  gains  in  terms  of  protecting  human  health  and  the  environment, 

33 COM/2018/0179 final - 2018/088 (COD)  
34 When considering the appropriate risk management for chemicals, a substance can be assessed in an isolated 
context (substance-specific; risk assessments completed on given substances under given settings) or as part of a 
substance group, i.e. chemicals with similar properties.  

8 

  
 
                                                 
accelerating  the  pace  of  the  hazard  and  risk  assessment  processes  and  cost  savings  for 
industry, because it would avoid replacement of hazardous substances by alternatives that are 
likely  to  be  banned  subsequently.  Finding  a  meaningful  way  of  defining  the  group  of 
substances remains however an open challenge.  

3.3. COMMUNICATION OF HAZARD AND SAFETY INFORMATION  

A recent Eurobarometer survey35 found that less than half of the respondents (45%) feel well 
informed about the potential dangers of the chemicals contained in consumer products. The 
relatively  low  level  of  understanding  of  certain  pictograms,  labels  and  precautionary 
statements is partly due to the overload of information e.g. too much text or chemical names 
that consumers are not familiar with printed  in multiple languages. In other cases, it can be 
due  to  overlaps  in  legal  requirements  e.g.  between  the  CLP  Regulation,  the  Detergents 
Regulation and/or the Cosmetic Products Regulation. This makes it difficult for downstream 
users  and  consumers  to  focus  on  the  essential  hazard  information.  The  communication  of 
hazard and safety information to consumers can thus be improved and simplified, including 
by using digital technologies such as Q-R codes.  

At the same time, the lack of some information on consumer goods impacts the consumers’ 
ability  to  make  informed  choices.  This  may  be  the  case  regarding  the  lack  of  labelling 
requirements on environmental hazards for cosmetic products. Also, the current approach to 
allergens lacks  coherence  with  respect  to  the  provision  of  consumer  information  and  to  the 
assessment of risks to human health. It also creates overlaps in terms of labelling obligations. 
Improvements  in  the  current  approach  to  allergens  could  therefore  help  consumers  to  be 
better protected and informed.  

The Fitness Check has  also  identified challenges regarding  the Classification and Labelling 
Inventory  held  by  ECHA,  which  affect  its  value  as  a  hazard  communication  tool.  The 
Inventory contains classification and labelling information for the substances to be placed on 
the  market  as  notified  by  manufacturers  and  importers.  However,  there  are  often  multiple 
classifications  for  the  same  substance  because  different  notifiers  fail  to  arrive  at  an  agreed 
entry despite the legal obligation to make every effort to do so and despite ECHA’s and the 
Commission’s efforts  to provide support to companies.  This  situation is exacerbated by the 
lack  of  a  legal  basis  for  ECHA  to  perform  quality  checks  of  the  self-classifications  and  to 
ensure that the Inventory does not contain any obsolete notifications or errors. 

3.4. CONSISTENCY OF RISK MANAGEMENT MEASURES  

A  potential  important  gap  is  the  lack  of  an  overarching  approach  to  the  protection  of 
vulnerable  groups,  as  highlighted  during  the  consultation  activities  by  several  stakeholders 
representing civil society and NGOs. Reference to vulnerable groups is not systematic across 
the  legislation  and  risks  to  these  groups  are  not  always  addressed  in  a  consistent  manner 
across product/risk/sector specific legislation. Where such legal provisions do exist, risks are 
taken  into  consideration  on  a  case-by-case  basis  with  differences  in  definition  and  wording 
used. This could lead to different levels of protection between different pieces of legislation 
for the same vulnerable group (e.g. children) or for those groups that are particularly sensitive 
to certain hazardous substances (e.g. unborn children, young infants and adolescents).  

35 Special Eurobarometer 468  

9 

  
 
                                                 
Some  inconsistencies  have  been  identified  regarding  risk  management  decisions  in  the 
various  pieces  of  legislation  as  regards  endocrine  disruptors,  substances  that  are  persistent, 
bio-accumulative,  toxic,  substances  that  are  very  persistent  and  very  bio-accumulative  and 
substances fulfilling the classification criteria for specific target organ toxicity. It is important 
to ensure consistency across the EU legislation, including for substances of similar concern to 
substances  that  are  carcinogenic,  mutagenic  and  reprotoxic.  The  potential  added  value  of 
introducing new hazard classes in the CLP Regulation (e.g. terrestrial toxicity, neurotoxicity, 
immunotoxicity,  endocrine  disruption,  persistent  bioaccumulative  and  toxic,  very  persistent 
very bioaccumulative) could be explored.  
In its recently adopted Communication on endocrine disruptors36 the Commission undertook 
to  launch  a  cross-sectoral  Fitness  Check  to  assess  whether  the  relevant  EU  legislation  on 
endocrine disruptors is fit for purpose. The Fitness Check will allow an analysis of how the 
different provisions on and approaches to endocrine disruptors interact, will identify possible 
gaps,  inconsistencies  or  synergies,  and  assess  their  collective  impact  in  terms  of  costs  and 
benefits  for  human  health  and  the  environment,  the  competitiveness  of  EU  farmers  and 
industry, and international trade.   

In  the  context  of  scientific  uncertainty  and  lack  of  or  limited  knowledge,  the  precautionary 
principle is an important element in helping to ensure the protection of human health and the 
environment  against  potential  risks,  the  avoidance  of  potential  costly  future  impacts  and 
remediation,  and  the  avoidance  of  disproportionate  or  unnecessary  risk  management  costs. 
The Fitness Check highlighted the case of Bisphenol A (BPA) as a positive example of the 
use of the precautionary principle37. In this case, baby bottles containing BPA were banned 
from being placed on the market and imported into the EU, to avoid infants’ exposure to BPA 
and possible negative physical and mental consequences. In the public consultation, a number 
of  NGOs,  trade  unions  and  some  Member  State  competent  authorities  still  expressed  their 
concerns about the practical application of the precautionary principle considering that it has 
been  applied  in  very  few  instances  in  the  chemicals  policy  area.  Its  practical  application 
therefore warrants further attention.  

3.5. RISK  ASSESSMENT,  KNOWLEDGE  GAPS  AND  CHALLENGES  IN  KEEPING  UP  WITH 

SCIENCE  

The proper functioning of the EU chemicals legislation and its capacity to respond to future 
challenges  depends,  amongst  other  things,  on  the  ability  of  the  EU  and  Member  States  to 
make  their  decisions  based  on  robust  and  relevant  up-to-date  data.  Enormous  efforts  have 
been  made  at  the  EU  and  Member  State  level  to  ensure  that  the  necessary  data  to  take 
effective chemical risk management decisions is available, comparable and of good quality. 
Likewise, the scientific understanding of how hazardous chemicals impact human health and 
the  environment  has  improved  significantly  over  the  last  two  decades.  The  current  EU 
knowledge base on chemicals – including their properties, data on eco-toxicity of chemicals 

36 COM(2018) 734 final 
37  http://europa.eu/rapid/press-release_IP-11-664_en.htm;  Commission  Regulation  (EU)  2018/213  of  12 
February 2018 on the use of bisphenol A in varnishes and coatings intended to come into contact with food and 
amending  Regulation  (EU)  No 10/2011  as  regards  the use  of  that substance  in  plastic  food  contact  materials; 
applicable as of 6 September 2018 

10 

  
 
                                                 
and on chemical uses and exposures – is unique in the world and is, in many instances, made 
available also to governments, industries and stakeholders beyond the EU.  

Nevertheless,  important  knowledge  gaps  still  remain,  in  particular  regarding  exposure  to 
hazardous chemicals, their use and their impacts on humans and the environment, including 
on  biodiversity  and  ecosystems’  resilience.  Similar  concerns  exist  regarding  new  and 
emerging  chemical  risks.  The  role  of  hazardous  chemicals  in  the  complex  interaction  with 
other  environmental  stressors  and  their  actual  contribution  to  the  effects  seen  in  the 
environment  are  not  fully  understood.  This  means  that  the  current  regulatory  framework, 
including test and assessment methods, typically cannot focus on these long term, large scale 
and  complex  environmental  effects.  EU  research  and  innovation  funding  remain  therefore 
paramount  to  overall  improve  human  and  environmental  monitoring  and  to  close  these 
knowledge  gaps.  Information  thus  gathered  could  also  feed  into  an  EU-level  early  warning 
system for identifying new, emerging chemical risks. 

Information on exposure to hazardous chemicals is necessary to develop exposure scenarios 
with  regard  to  the  intended,  normal,  reasonable  and/or  foreseeable  use  of  a  product  or 
foreseeable/predictable  situation.  The  evidence  shows  that  industry  and  public  authorities 
may  not  always  be  aware  of  all  the  uses  of  certain  hazardous  chemicals  that  have  a  broad 
range  of  applications  in  a  myriad  of  different  consumer  products.  Moreover,  there  is  only 
limited 
the  overall  volumes  of  hazardous  chemicals 
emitted/released into the environment. These two elements combined can affect their capacity 
to  develop  realistic,  acceptable  and  robust  exposure  scenarios  and  as  a  consequence  to 
identify the most appropriate risk management measures.  

information  available  about 

Authorities in charge of hazard and risk assessment are not always aware of all the potentially 
relevant  or  the  latest  information  and  data  necessary  for  decision-making  process.  In  this 
regard,  peer-reviewed  studies  are  an  important  complement  provided  that  they  are  reliable 
and properly documented, in particular for the identification of, and reaction to, early warning 
signals.  Tools  that  bring  together  and  monitor  recent  and  useful  scientific  publications  and 
ensure  that  authorities  are  well  aware  of  what  is  available  are  however  lacking.  Moreover, 
there are still barriers to the use and acceptance of alternative (non-animal) test methods38 for 
regulatory purposes, partially linked to gaps in the available test guidelines.  

Risk  assessment  processes  implemented  within  the  EU  chemicals  legislation  are  not 
expressly designed to identify and assess potential human health and environmental risks of 
different hazardous chemicals acting in combination (also known as the ‘combination effect’ 
or  ‘cocktail  effect’).  The  Commission  noted39  back  in  2012  that  the  then  “current  EU 
legislation does not provide for a comprehensive and integrated assessment”, and announced 
a  number  of  follow-up  actions  to  remedy  this.  Since  then,  progress  has  been  made  with 
regard to knowledge building and the development of risk assessment methodologies in the 
context  of  plant  protection  products40  and  in  the  broader  context  of  the  food  chain41. 

38 Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection 
of animals used for scientific purposes amongst other promotes the development, validation and implementation 
of alternative (non-animal) test methods. 
39 COM/2012/0252 final 
40 https://www.efsa.europa.eu/en/press/news/130712 ; https://www.efsa.europa.eu/en/press/news/180626 

11 

  
 
                                                 
Nevertheless,  a  workable  methodological  framework  for  all  chemicals  has  not  been  agreed 
upon. Requirements to ensure the risk assessment of combination effects exist only in some 
pieces of legislation (e.g. in the area of pesticides) while other relevant pieces of legislation 
do not contain legal provisions that cater for such an assessment. 

Lack of knowledge about substances in articles is increasingly concerning as the EU is in the 
process of shifting towards a more circular economy. While steps have been taken regarding 
traceability  of  hazardous  chemicals  in  waste  and  recycled  material  streams42,  the  shift 
towards  a  more  circular  economy  will  require  that,  instead  of  looking  at  the  potential  risks 
posed  by  hazardous  chemicals  during  one  and  unique  ‘life’  based  on  a  linear  ‘take-make-
dispose’  approach,  the  risk  assessment  may  need  to  take  into  account  the  potential  of  such 
hazarodus chemicals to re-enter the loop via recycling. The way hazard and risk assessments 
are carried out may need to be adapted accordingly, given the increasing consumer awareness 
and demand for sustainable and more circular products.  

3.6. GLOBAL COMPETIVENESS, INNOVATION AND SUSTAINABILITY   

The  EU  chemicals  legislation  has  been  instrumental  in  ensuring  free  circulation  of 
substances, mixtures and articles through harmonisation of standards and requirements. To a 
large  degree,  there  is  a  level  playing  field  in  Europe,  and  chemicals  legislation  has 
strengthened  the  internal  market  and  enhanced  the  competitiveness  of  EU  industry  as 
reflected  in  the  growth  in  intra-EU  trade43.  The  EU  chemicals  industry  remains 
internationally  competitive  although  the  European  share  of  global  sales  has  decreased44. 
Globalisation, a strong growth in the production of chemicals in other parts of the world and 
rapid technological change are the main challenges for the EU chemicals industry. Significant 
efforts will be needed by all interested parties at all levels and most importantly by industry 
itself  to  maintain  and  reinforce  Europe's  industrial  leadership45.  The  main  assets  of  the  EU 
chemicals  industry  are  a  high  level  of  technological  development,  a  skilled  and  talented 
workforce  and  a  world-class  science  base.  These  assets,  combined  with  the  EU’s  global 
leadership on many sustainability46 and chemicals related aspects47, provide a solid basis for 
tackling these challenges.  

The internal market is another asset that the EU and Member States authorities as well as the 
EU  industry  can  build  upon.  Digitisation,  IT  tools  and  other  novel  and  smart  technologies 
offer many opportunities. The uptake of smart technologies can offer better communication 
of chemical hazard and safety information to consumers as already explained above. Reaping 

41 https://www.efsa.europa.eu/en/consultations/call/161024a  
42 COM(2019) 190 final 
43 The intra-EU sales of chemicals increased from EUR 219 billion in 2006 to EUR 280 billion in 2016 (+28%). 
Domestic sales (sales in the home country) dropped from EUR 184 billion in 2006 to EUR 81 billion in 2016 (-
56%). Extra-EU exports increased from EUR 102 billion in 2006 to EUR 146.2 billion in 2016 (+43%). Source: 
CEFIC Facts and Figures Report, 2017 
44 Ibidem  
45 COM/2017/0479 final 
46 Reflection Paper ‘Towards a Sustainable Europe by 2030’ 30 January 2019 
47 The United Nations Strategic Approach to Chemicals Management (SAICM); http://www.saicm.org   

12 

  
 
                                                                                                                                                        
the benefits of the digital age also means potential burden reduction for SMEs, improving the 
enforcement and compliance including via the real-time use of data and monitoring, as well 
as  reinforcing  cooperation  between  competent  authorities,  including  customs  and  market 
surveillance authorities48. 
The available data on production and consumption of  hazardous chemicals49 shows that the 
share of industrial chemicals hazardous to health and the environment in the total chemicals 
production  has  remained  relatively  unchanged.  No  legislation-specific  information  is 
available to assess the pace of substitution of hazardous substances. Statistics do not allow to 
directly link changes in the share of chemicals hazardous to health and the environment to the 
EU intervention. Nevertheless, the evidence gathered seems to indicate that the EU chemicals 
legislation has the potential to act as a driver of innovation, in particular with regard to the 
achievement  of  the  UN  Sustainable  Development  Goals.  Europe  has  already  started  to 
implement  and  to  deliver  many  of  its  commitments  regarding  the  shift  towards  a  more 
circular  economy50.  Additional  support  to  the  development  of  smart,  innovative,  and 
sustainable  chemicals  and  to  encourage  ‘green  chemistry’51  will  be  critical  to  ensure 
sustainability as well as the competitiveness of the EU chemicals industry for the future.  

CONCLUSIONS 

The  purpose  of  this  Fitness  Check was  to  take a  step  back  and  to  look at  what the EU  has 
achieved in the area of chemicals management and how it performs.  We have come a long 
way  and  this  Fitness  Check  has  found  that,  overall,  the  EU  framework  of  chemicals 
legislation  is  fit  for  purpose  and  delivers  a  high  level  of  protection  of  people  and  the 
environment in balance with the needs of an efficiently functioning internal market and of a 
competitive and innovative chemicals industry.  

It  has  also  found  a  number  of  areas  where  there  is  scope  for  further  improvement, 
simplification and burden reduction or that warrant attention.  

As  explained  in  the  Introduction  of  this  Report,  the  Fitness  Check  is  a  further  step  in  the 
reflection  process  on  the  EU  chemicals  legislation.  It  is  intended  to  provide  a  common 
understanding of the challenges and to invite all interested parties to get involved.  

The Commission invites the European Parliament, the Council, the European Economic and 
Social  Committee and  the Committee of the Regions to  discuss these findings and to bring 
their own contribution to the debate.  

The findings of this Fitness Check will help ensure that any improvements and refinements to 
be  made  in  the  chemicals  policy  area  are  well-founded  and  well-focused.  It  is  particularly 
important  that  the  different  pieces  of  the  EU  chemicals  legislation,  including  those  not 
assessed in this Fitness Check, such as REACH, continue to consistently deliver a high level 

48  In  line  with  the  Commission  communication  'The  Goods  Package:  Reinforcing  trust  in  the  single  market' 
(COM(2017/0787 final)  
49 http://ec.europa.eu/eurostat/statistics-explained/index.php/Chemicals_production_and_consumption_statistics 
50 COM(2019) 190 final 
51  Green  chemistry  is  the  utilisation  of  a  set  of  principles  that  reduces  or  eliminates  the  use  or  generation  of 
hazardous  substances  in  the  design,  manufacture  and  application  of  chemical  products.  Definition  by  Anastas 
and Warner (1998). 

13 

  
 
                                                 
of protection of human health and the environment and to ensure the efficient functioning of 
the internal market while contributing to the overall objective of enhancing competitiveness 
and innovation.  

14