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
Date: 2019-07-18
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, 18.7.2019  SWD(2019) 199 final/2 PART 1/3  CORRIGENDUM This document corrects document SWD(2019) 264 final of 25.6.2019.  The watermark "DRAFT" visible from page 6 onwards has been removed. The text shall read as follows: 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 {COM(2019) 264 final}  
 
 
TABLE OF CONTENTS  

1 

INTRODUCTION .............................................................................................................. 3 

2  BACKGROUND TO THE INTERVENTION ................................................................... 6 

2.1  Description of the initiative ......................................................................................... 6 

2.2  An overview of the EU chemicals industry and related sectors ................................ 13 

2.3  Baseline ..................................................................................................................... 14 

3 

STATE OF PLAY ............................................................................................................. 16 

3.1 

Implementation of the EU chemicals legislation ....................................................... 16 

3.2  Enforcement of the EU chemicals legislation ........................................................... 17 

4  METHODOLOGY ........................................................................................................... 21 

4.1  Description of methodology: quantification and data collection ............................... 21 

4.2  Limitations and robustness of findings ...................................................................... 26 

ANSWERS TO THE EVALUATION QUESTIONS ............................................................. 30 

5  EFFECTIVENESS ............................................................................................................ 30 

5.1  Evaluation question:  to what extent does  the EU legislative framework for the risk 
management of chemicals meet its objectives? .................................................................... 30 

5.2  Evaluation question: what factors affect (either positively or negatively) the correct 
functioning  of  the  EU  legislative  framework  for  the  hazard  identification  and  risk 
management of chemicals? What are the consequences  or effects that were  not  originally 
planned for? .......................................................................................................................... 41 

6  EFFICIENCY ................................................................................................................... 59 

6.1  Evaluation  question:  what  are  the  costs  and  benefits  associated  with 
the 
implementation  of  the  legislative  framework  for  chemicals?  What  are  the  key  drivers  for 
those costs and benefits? To what extent are the costs proportionate to the benefits? ........ 59 

6.2  Evaluation question: what aspects of the functioning of the framework are the most 
efficient and what are the least efficient? ............................................................................. 71 

7  COHERENCE ................................................................................................................... 78 

7.1  Evaluation question: to what extent are the legal acts consistent in how they attempt 
to  reach  the  stated  objectives  and  can  differences  in  the  hazard  identification  and  risk 
management of chemicals be justified? ............................................................................... 78 

7.2  Evaluation  question:  what, 
inconsistencies,  contradictions, 
if  any,  are 
unnecessary  duplication,  overlap  or  missing  links  between  different  pieces  of  legislation? 
Are these leading to unintended results? .............................................................................. 82 

the 

8  RELEVANCE ................................................................................................................... 92 

8.1  Evaluation  question:  to  what  extent  do  the  objectives  of  the  legislative  framework 
for chemicals meet the current needs? ................................................................................. 92 

1 

 
 
8.2  Evaluation  question:  to  what  extent  does  the  current  legislative  framework  for 
chemicals take into account health, environmental, social and economic consequences that 
are relevant to citizens and stakeholders? ............................................................................ 98 

8.3  Evaluation question: to what extent are the current procedures transparent and robust 
enough  to  enable  decisions  related  to  hazard  identification,  risk  assessment  and  risk 
management to be relevant and evidence-based? .............................................................. 101 

9  EU VALUE ADDED ...................................................................................................... 104 

10  CONCLUSIONS ............................................................................................................. 106 

A comprehensive and generally well-functioning framework ........................................... 107 

Burden reduction and simplification .................................................................................. 108 

Needs for improvement ...................................................................................................... 110 

11  LIST OF ANNEXES ...................................................................................................... 113 

2 

 
 
 
 
 
 
1  INTRODUCTION 

Chemicals  are  everywhere  in  our  modern  society.  They  are  an  integral  part  of  most  human 
activities and production processes and they are present in most consumer products, be it for 
food,  electronics,  toys,  clothes  or  industrial  machines.  They  have  contributed  to  the 
improvement of human health and life expectancy, and to our societal comfort and wellbeing. 
They  play  an  important  role  in  the  EU  industrial  competitiveness  and  creating  jobs.  On  the 
flipside, however, are the potential and actual human health and environment risks that result 
from  exposures  to  hazardous  chemicals.  The  overall  aim  of  50  years  of  EU  policy  on 
chemicals  is  to  promote  their  safe  use  with  a  view  to  improving  their  overall  sustainability 
including  human  health  and  environment  protection,  competitiveness,  innovation,  internal 
market,  growth  and  jobs.  To  do  so  the  EU  chemicals  legislation  (what  we  call  today,  'the 
European  Union  chemicals  acquis')  identifies  hazardous  chemicals  and,  for  those  chemicals 
where  the  human  health  and  environmental  risks  require  action,  establishes  measures  to 
manage these risks.  

The Commission decided to undertake this Fitness Check of chemicals legislation other than 
REACH1 ('the Fitness Check') to see what elements of the European chemicals  acquis work 
well  and  what  needs  to  be  improved,  both  in  terms  of  meeting  the  policy  objectives  and  in 
terms  of  reducing  regulatory  burden.  Unlike  most  evaluations,  the  Fitness  Check  is  not  an 
evaluation of one piece of legislation2 but covers more than 40 different pieces of legislation 
(see  Annex  4  Table  1).  It  covers  legislation  that  addresses  chemical  hazard  identification, 
assessment  classification  and  labelling,  risk  assessment,  and  risk  management,  including 
worker  safety,  transport,  environmental  protection,  chemical-specific  and  product-specific 
legislation.  

This Fitness Check focuses on how the chemical risk assessment and management processes 
work  across  the  EU  chemicals  acquis.  This  means  that  in  some  cases,  the  focus  is  on  the 
entire  piece  of  legislation  as  all  of  its  requirements  and,  hence,  associated  regulatory  costs 
relates to chemical hazard/risk assessment and risk management. Examples include the CLP 
Regulation, the Plant Protection Products Regulation, the Residues of Pesticides Regulation, 
the  Biocidal  Products  Regulation,  the  Cosmetics  Products  Regulation,  the  Detergents 
Regulation, the Chemical Agents Directive, and the Carcinogens and Mutagens Directive. For 
many  of  the  other  pieces  of  legislation  only  certain  requirements  were  relevant  for  the 
purposes of this Fitness Check, for example: the Toy Safety Directive, the water and water-
related legislation, the Waste Shipments Directive, the Industrial Emissions Directive and the 
Seveso III Directive (see Annex 8). 

To assess this, the Fitness Check has:  

  Mapped  out  links  between  hazard  identification  and  consequent  risk  management  in 

downstream legislation on the basis of generic risk considerations (GRC).  

  Mapped out the links between specific risk assessments (SRA) and the consequent risk 

management.  

1 Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals 
2 Section 2.1.3 sets out ongoing evaluations of specific legislation also covered under this Fitness Check 

3 

 
 
                                                 
  Examined  the  overall  effectiveness,  efficiency,  relevance,  coherence  and  EU  added 
value of the two risk management approaches (GRC and SRA), on their own but also 
compared to one another, as adopted in the chemicals legislation. 

Moreover, as announced in the Circular Economy Action Plan, the Commission has assessed 
the  interface  between  waste,  products  and  chemicals  legislations.  The  Fitness  Check  takes 
into consideration the findings presented in the related 'Interface' Communication.3 
This Fitness Check complements the REACH Evaluation4. Together, they cover the core EU 
legislative framework for the risk management of chemicals. The interface between REACH 
and other legislation is covered by the REACH review. Some REACH-related aspects are also 
covered  under  this  Fitness  Check  in  particular  where  REACH  is  a  central  consideration  in 
assessing  the  coherence  of  different  pieces  of  chemicals  legislation  (e.g.  the  identification, 
assessment  and  classification  of  persistent,  bioaccumulative  and  toxic  and  very  persistent, 
very bioaccumulative substances (PBTs/vPvBs)). 

Figure  1  presents  the  intervention  logic  of  the  chemicals  legislation  covered  by  this  Fitness 
Check. It summarises how the EU chemicals acquis is envisaged to lead to positive impacts 
on health, the environment and the functioning of the internal market as well as to enhanced 
competitiveness  and  innovation.  It  presents  the  links  between  the  needs,  the  objectives,  and 
the  actions  taken  by  different  actors  for  each  of  the  key  steps  in  the  hazard  and  risk 
assessment  processes.  It  also  sets  out  the  related  output  of  all  these  actions  and  general 
outcomes of the implementation and application of  the EU chemicals  acquis (e.g. improved 
knowledge on substances, hazardous substances identified, etc.). 

3  Communication  on  the  implementation  of  the  circular  economy  package:  options  to  address  the  interface 
between chemical, product and waste legislation; COM(2018) 32 final 
4  Communication  from  the  Commission  to  the  European  Parliament,  the  Council  and  the  European  Economic 
and  Social  Committee  on  Commission  General  Report  on  the  operation  of  REACH  and  review  of  certain 
elements Conclusions and Actions; 5 March 2018; COM(2018) 116 final and SWD(2018) 58 final 

4 

 
 
 
 
                                                 
Figure 1 The intervention logic evaluated in this Fitness Check 

5 

 
 
 
2  BACKGROUND TO THE INTERVENTION 

2.1  Description of the initiative 

2.1.1  Objectives of EU chemicals legislation 

The primary objectives of EU chemicals acquis are:  

1.  Ensuring  a  high  level  of  protection  of  human  health  from  the  adverse  effects  of 

hazardous chemicals. 

2.  Ensuring  a  high  level  of  protection  of  the  environment  from  the  adverse  effects  of 

hazardous chemicals.  

3.  Supporting  and  enhancing  the  efficient  functioning  of  the  internal  market  for 
chemicals and the competitiveness and innovativness of EU industry and business.   

Specific  pieces  of  legislation  may  have  more  specific  objectives  related  to  chemicals  (see 
Annex 4 Table 1), such as protecting selected vulnerable groups (e.g. children), encouraging 
substitution  to  less  hazardous  alternatives,  reducing  the  number  of  animals  used  for  testing 
chemicals, ensuring the free movement of specific products or encouraging improvements in 
the  occupational  safety  and  health  of  workers.  It  is  also  a  general,  if  not  always  explicitly 
stated,  objective  of  the  EU  chemicals  legislation  to  improve  the  knowledge  of  chemical 
hazards and risks. Furthermore, some of the legislation within the scope of this Fitness Check 
may  also  include  objectives  that  concern  other  policy  areas,  such  as  ensuring  agricultural 
productivity and sustainability or promoting products that have a high level of environmental 
performance.  

The  EU  has  also  played  a  leading  role  in  the  development  of,  and  is  committed  to,  several 
global objectives related to chemicals. The EU and its Member States, committed to the UN 
objective  of  a  sound  management  of  chemicals  throughout  their  life  cycle  in  2002,  often 
referred to as the ‘World Summit of Sustainable Development (WSSD) 2020 goal’5. In 2006, 
governments  and  stakeholders  agreed  on  the  Strategic  Approach  to  International  Chemicals 
Management (SAICM6) (UNEP, 2006), a global policy framework to promote safe chemicals 
management with the explicit aim of implementing the WSSD 2020 Goal on chemicals and 
waste.7  In  2015,  the  EU  committed8  to  the  United  Nations’  2030  Agenda  for  Sustainable 
Development including the Sustainable Development Goals (SDGs) (UN, 2015)9. Several of 
the  SDGs  relate  directly  or  indirectly  to  chemicals  and  chemical  policy  (in  particular  SDGs 
3.9,  6.3,  12.4).  It  should  be  noted,  however,  that  apart  from  some  international 
competitiveness  assessment  aspects,  the  Fitness  Check  scope  did  not  include  a  detailed 
assessment  of  performance  against  the  abovementioned  international  objectives  and 
commitments.  The  focus  was  on  the  performance  of  the  EU  chemicals  acquis  in  delivering 
against the core policy objectives within the EU context. 

5 It was expanded upon in paragraph 23 of the Johannesburg Plan of Implementation (JPOI) (UN, 2002). 
6 http://www.saicm.org/ 
7 mainstreamed into the Europe 2020 Strategy (COM(2010) 2020 final) 
8 COM(2016) 739 final  
9 https://www.un.org/sustainabledevelopment/sustainable-development-goals/ 

6 

 
 
                                                 
2.1.2  The Framework of EU Chemicals Legislation 

The EU legal framework for chemicals comprises not only chemicals legislation in the strict 
sense of the word – directly regulating chemical substances and mixtures – but also legislation 
regulating  conditions  under  which  chemicals  are  manufactured,  treated  or  used  (e.g. 
occupational health and safety or environmental legislation) or regulating products, in which 
chemicals are used (e.g. toys, medical devices and food contact materials). Furthermore, there 
are chemicals-related provisions in several pieces of environmental protection legislation such 
as  the  Water  Framework  Directive,  the  Waste  Framework  Directive  and  the  Industrial 
Emission Directive.  

The  development  of  EU  legislation  on  chemicals  started  in  1967  with  the  adoption  of  a 
Directive10  that  harmonised  the  Member  States'  rules  for  the  classification,  packaging  and 
labelling of chemical substances across the then European Economic Community. Since then 
a multitude of different pieces of legislation have been adopted (see Figure 2; see also Annex 
4  Table  2)  that,  to  a  greater  or  lesser  degree,  address  the  risk  management  of  hazardous 
chemicals. In 2001 the European Commission adopted a White Paper setting out the strategy 
for  a  future  chemicals  policy,  ultimately  leading  to  the  adoption  of  REACH  in  2006,  the 
Classification, Labelling and Packaging Regulation ('the CLP Regulation' which repealed the 
Dangerous  Substances  and  Dangerous  Preparations  Directives  in  2008),  and  to  the 
establishment of the European Chemicals Agency in Helsinki (ECHA) in June 2007.  

The EU has also committed to a number of legally binding international agreements related to 
chemicals, which are implemented through EU chemicals-related legislation, 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)  (see  Annex  8 
Section 8.1.1 for further detail). 

10 Dangerous Substances Directive 67/548/EEC 

7 

 
 
                                                 
Figure 2 Some key pieces of EU chemicals legislation adopted since 1967 

The EU chemicals legislation has been a model for policy development in other parts of the 
world.11  The  knowledge  base  resulting  from  the  implementation  of  different  pieces  of  EU 
legislation  is,  in  many  instances,  made  available  to  government,  industry  and  stakeholders 
beyond the EU.  

2.1.3  Scope of the Fitness Check 

This  Fitness  Check  focuses  on  more  than  40  pieces  of  legislation  (see  Annex  4  Table  1). 
Those, together with REACH (which is outside the scope of this exercise) form the core of the 
EU  framework  of  chemicals  and  chemicals-related  legislation.  The  primary  criteria  for 
determining which pieces of legislation to include within the scope of the Fitness Check was 
the  existence  of  requirements  in  the  legislation  relating  to  hazard/risk  assessment  and  risk 
management  of  chemicals.  This  meant  including  horizontal  legislation  that  supports  the 
overall process of chemical hazard and risk assessment such as the Test Methods Regulation 
(440/2008/EC) and the Good Laboratory Practice Directives (2004/9/EC and 2004/10/EC).  

A meaningful way to categorise these pieces of legislation, given the risk management focus 
of this Fitness Check, is as follows (see also Annex 8 section 8.1.2): 

1)  Legislation  covering  chemical  hazard  identification  and  classification12:  Chemical 
Agents  Directive  (98/24/EC),  Carcinogens  and  Mutagens  at  Work  Directive 
(2004/37/EC), CLP Regulation (1272/2008/EC), Plant Protection Products Regulation 

11 Study on the cumulative health and environmental benefits of chemicals legislation p. 324 
12 sometimes together with risk assessment and risk management measures 

8 

 
 
 
 
                                                 
(1107/2009/EC), Asbestos Directive (2009/148/EC) and Biocidal Products Regulation 
(528/2012/EU).  

2)  Legislation covering chemical risk assessment and risk management measures: 
a)  Worker  safety  and  transport  legislation:  Pregnant  Workers  Directive  (1992/85/EEC), 
Young  People  at  Work  Directive  (1994/33/EC),  the  Chemical  Agents  Directive 
(1998/24/EC) and Carcinogens and Mutagens at Work Directive (2004/37/EC). 

b)  Environmental protection legislation: the Urban Waste Water Directive (91/271/EEC), 
Water  Framework  Directive  (2000/60/EC)  and  Industrial  emissions  (integrated 
pollution prevention and control) Directive (2010/75/EU). 

c)  Chemicals  control 

legislation:  Contaminants 

in  Food  and  Feed  Regulation 
(315/93/EEC), Persistent Organic Pollutants Regulation (850/2004/EC), and Directive 
(2002/32/EC),  Residues  of  Pesticides  Regulation  (396/2005/EC),  Plant  Protection 
Products  Regulation  (1107/2009/EC),  Biocidal  Products  Regulation  (528/2012/EU) 
and Export and Import of Hazardous Chemicals Regulation (649/2012/EU). 

d)  Products  control  legislation:  Medical  Devices  Directives  (93/42/EEC;  90/385/EEC; 
98/79/EC)13, Drinking Water Directive (98/83/EC), General Product Safety Directive 
(2001/95/EC),  Detergents  Regulation 
(648/2004/EC),  Toy  Safety  Directive 
(2009/48/EC),  Cosmetic  Products  Regulation  (1223/2009/EC),  Food  Contact 
Materials  Regulations  (10/2011/EC  and  450/2009/EC)  and  Pressure  Equipment 
Directive (2014/68/EU).  

3)  Supporting  and  horizontal 

legislation:  Good  Laboratory  Practice  Directives 
(2004/9/EC  and  2004/10/EC),  Test  Methods  Regulation  (440/2008/EC),  and 
Protection of Animals Used For Scientific Purposes Directive (2010/63/EU).  

This Fitness Check is not an in-depth evaluation of each individual piece of legislation within 
its scope. Instead, it aims to assess the functioning, performance and coherence of the overall 
framework  with  a  particular  focus  on  the  hazard/risk  assessment  and  risk  management  of 
chemicals.  In  addition  and  in  parallel,  the  Commission  is  conducting  targeted  Better 
Regulation evaluations of a number of pieces of chemicals legislation within the scope of the 
Fitness  Check,  including  the  Plant  Protection  Products  and  the  Residues  of  Pesticides 
Regulations,  the  Urban  Waste  Water  Treatment  Directive,  the  Water  Framework  Directive, 
the Food Contact Materials legislation and the Detergents Regulation (see Annex 4 Table 4).  

At the margins, there is some additional legislation that this Fitness Check could have covered 
e.g.  pharmaceuticals  legislation  (human14  and  veterinary  products15)  and  food  additives16 
legislation. It was, however, considered that the risk and hazard assessments performed under 
these pieces of legislation are used slightly differently compared with those performed under 

13  To  be repealed  (subject  to  exceptions)  on 26  May 2020 and 26  May 2022  respectively  by  Regulation (EU) 
2017/745 and Regulation (EU) 2017/746 which entered into force on 25 May 2017 
14 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  
15 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 
16 Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food 
additives 

9 

 
 
                                                 
the main body of EU chemicals legislation (e.g. an assessment of the risk trade-offs between 
the health benefits of the medical product versus potential undesired side-effects). REACH is 
generally  outside  the  scope  of  this  exercise.  It  is  subject  to  its  own  legal  review  deadlines. 
While the first evaluation of REACH was finished in 2013, the second evaluation had already 
started when this Fitness Check was launched and was completed by the time that this Fitness 
Check  entered  its  finalisation  phase.  Nevertheless,  given  the  importance  of  hazard 
identification  and  classification  criteria  under  this  Fitness  Check,  Annex  XIII  to  REACH 
(PBT)  and  very  persistent  and  very 
covering  persistent,  bioaccumulative, 
bioaccumulative (vPvB) criteria was included in the scope of this exercise. In general, where 
considered  relevant  from  a  comparative  perspective,  links  to  these  pieces  of  legislation  are 
covered as part of the coherence analysis. 

toxic 

2.1.4  Main steps: from hazard identification to risk management measure  

Chemical  risk  assessment  involves  the  analysis  of  the  inherent  hazardous  properties  of  a 
substance  or  a  mixture  and  the  extent  of  exposure  to  that  substance  or  mixture.  The  human 
health and environmental risks related to exposure to hazardous chemicals are addressed via 
the hazard and risk assessment procedures and requirements set out in the different key pieces 
of the EU chemicals legislation such as the CLP, the Plant Protection Products and Biocidal 
Products Regulations, etc. The main steps of these procedures involve: 

  hazard identification (based on toxicity tests and other relevant information); 
  dose (concentration) – response (effect) assessment; 
  exposure assessment – exposure scenarios (based on models and measurements of the 

occurrence of the chemical); 
risk characterisation; and 
risk estimation. 

 
 

Risk management measures – which can be policy-based and/or technical in nature - are then 
decided in light of the identified hazards and/or risks. Risk management measures can range 
from (and involve a mix of) a total ban to any condition to the manufacture, use or placing on 
the market of chemicals (such as setting emission/concentration/migration limits, obligations 
to  communicate  hazards  and  risks,  labelling  requirements,  obligations  to  use  personal 
protection equipment, etc.). 

2.1.5  Risk management approaches 

There  are  two  basic  approaches  to  risk  management  often  used  in  combination,  in  the  EU 
chemicals  acquis:  one  based  on  specific  risk  assessment  (SRA)  and  the  other  one  based  on 
generic risk considerations (GRC) (see Annex 8 Section 8.2.1).  

The  main  difference  between  these  two  approaches  is  the  point  in  time  when  the  exposure 
assessment is considered and the specificity of the exposure assessment. For risk management 
based  on  GRC,  the  potential  exposures  and  risks  are  considered  generically,  prior  to  the 
adoption of legislation. The GRC-based approach is built into the legislation in the form of an 
automatic trigger of pre-determined risk management measures (e.g. packaging requirement, 
communication requirement, restrictions, bans, etc.) based on the hazardous properties of the 
chemical,  without  the  need  or  possibility  to  assess  and  take  into  account  specific  exposure 
levels  for  a  specific  situation  or  use.  For  example,  under  the  Cosmetic  Products  Regulation 
any  substance  classified  as  carcinogenic,  mutagenic  or  toxic  for  reproduction  (CMR) 

10 

 
 
categories 1A/B and 2, shall be banned from use in cosmetics (subject to strict derogations), 
given  the  fact  that  direct  exposure  of  humans  is  taking  place  through  the  application  of  a 
cosmetic product on the external parts of the human body (or teeth or mucous membranes of 
the oral cavity). Similar approaches have been taken for active ingredients in plant protection 
products and biocides, for substances in toys, etc.  

The  decision  to  link  particular  hazard  properties  (e.g.  CMR,  persistent  bioaccumulative  and 
toxic substances (PBTs), endocrine disruptors (EDs)) to automatic risk management measures 
without the intervening step of a specific risk assessment is done on the basis of generic risk 
consideration  without  prejudice  to  performing  also  a  full  risk  assessment  for  the  other 
properties  of  the  substances  which  are  not  linked  to  the  related  hazard  properties.  In  the 
legislation evaluated in this Fitness Check, the generic risk consideration approach is typically 
applied for the following use applications and the following substances:  

Use applications: 

 

  when there is a need to obtain and pass on information to enable [further/specific] risk 
assessment  or  risk  management  (e.g.  labelling  obligations  under  the  CLP,  labelling 
requirements and use instructions under the Plant Protection Products and the Biocidal 
Products Regulations).  
for use in widely dispersive or open applications which result in a significant exposure 
of humans or the environment (e.g. plant protection products). 
for use in applications where the exposure is considered to be more difficult to control 
and monitor (e.g. plant protection products). 
for use in applications resulting in exposure of vulnerable groups (e.g. children). 
for  use  to  prioritise  the  risk  assessment  of  certain  chemicals  and  under  certain 
conditions (e.g. food contact materials) 

 
 

 

Substances: 

 

 

for  substances  with  hazard  properties  that  result  in  severe  adverse  effects  on  human 
health or the environment should exposures occur (e.g. CMRs, PBTs, EDs, chemicals 
with Single Target Organ Toxicity (STOT) properties); and  
for  substances  where  it  is  difficult/impossible  to  identify  a  safe  threshold  and, 
therefore, where most specific risk assessments are likely to identify risks that lead to 
a need for risk management measures (e.g. PBTs, vPvBs, respiratory sensitisers). 

On  the  other  hand,  in  the  case  of  the  specific  risk  assessment  approach,  the  exposure 
assessment is performed on a case-by-case basis when each substance is risk assessed under a 
specific legal framework. The risk management measures are triggered based on the outcomes 
of the specific risk assessment which considers the use of the substances and in which both 
the hazards and the potential specific exposure scenarios for humans and the environment to 
the hazardous substance or mixture in question are assessed at the same time. 

The specific risk assessment approach is used more widely for uses which are not necessarily 
or obviously going to lead to widespread and difficult to control exposures and/or where the 
hazard properties of a substance are of less concern.  

In  many  instances,  individual  pieces  of  chemicals  legislation  use  a  combination  of  both  of 
these  approaches.  For  example,  the  Cosmetic  Products  Regulation  applies  the  specific  risk 

11 

 
 
management approach to establish lists of authorised substances as well as, where necessary, 
restrictions on  the  use  of  certain  substances  in certain situations. In  addition,  for  substances 
identified  and  classified  as  a  CMRs  categories  1A/B  and  2,  the  generic  risk  management 
approach  is  applied  (such  substances  shall  be  banned  and  cannot,  therefore,  be  used  in 
cosmetic products subject to strict derogations).  

2.1.6  Risk assessment and risk management processes and bodies involved 

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: 

The  necessary  hazard  identification,  exposure  assessment  and  risk  assessment  of  chemicals 
are  undertaken  through  a  number  of  separate  (but  closely  aligned)  processes  involving  EU 
expert  committees/bodies  associated  (see  Annex  8  Section  8.2.2).  These  committees/expert 
groups  are  mainly  established  in  association  with  different  pieces  or  groups  of  legislation. 
Examples include: 

 

 

 

 

 

the European Chemicals Agency (ECHA): covering the CLP, the Export and import of 
hazardous  chemicals  (PIC)  Regulation,  the  Biocidal  Products  Regulations)  and 
REACH; 
the European Food Safety Authority (EFSA): covering the Plant Protection Products 
and Residues of Pesticides Regulations as well as the Food Contact Materials and the 
Contaminants in Food and Feed legislation; 
the  Scientific  Committee  on  Consumer  Safety  (SCCS):  covering  the  Cosmetic 
Products  Regulation,  the  Toy  Safety  Directive  and  the  General  Product  Safety 
Directive (GPSD) 
the  Scientific  Committed  on  Occupational  Exposure  Limits  (SCOEL):  previously 
covering occupational safety and health legislation17; and 
the  Scientific  Committee  on  Health,  Environment  and  Emerging  Risks  (SCHEER): 
covering  health,  environmental  and  emerging  risks  and  broad,  complex  or 
multidisciplinary issues that require a comprehensive assessment of risks to consumer 

17 SCOEL’s competences in terms of occupational exposure to hazardous chemicals have been transferred since 
2019 to the Risk Assessment Committee (RAC) of ECHA. 

12 

 
 
 
                                                 
safety  or  public  health  and  related  issues  not  covered  by  other  European  Union  risk 
assessment bodies. 

2.2  An overview of the EU chemicals industry and related sectors 

The chemicals industry covers five main sectors (petrochemicals, polymers, basic inorganics, 
specialties and consumer chemicals) broken down into 16 subsectors. Five of these subsectors 
(paints,  varnishes  and  similar  coatings;  printing  ink  and  mastics;  soap  and  detergents,  and 
cleaning  and  polishing  preparations;  perfumes  and  toilet  preparations;  plastics  in  primary 
forms; and other organic basic chemicals) account for over 65% of EU chemical companies18.  

The chemicals industry is also characterised by geographical concentration with 85% of the 
EU  turnover  in  the  chemical  industry  concentrated  in  seven  countries  —  Germany  (30%), 
France  (14%),  the  Netherlands  (10%),  Italy  (10%),  Spain  (7%),  the  United  Kingdom  (7%), 
and Belgium (7%).19  

As  an  "enabling  industry",  the  chemical  industry  is  at  the  heart  of  the  EU  manufacturing 
industry, supplying two-thirds of its production to other industry sectors. Thus, a large range 
of  downstream  sectors  rely  on  the  use  of  chemicals  in  their  everyday  activities,  such  as  the 
automotive  and  aerospace  sectors,  the  paper  and  pulp  sector,  as  well  as  the  manufacture  of 
everyday  goods  such  as  textiles,  cosmetics,  toys,  etc.  Other  important  links  exist  with 
agriculture activities and services.  

The chemical manufacturing industry is the fifth largest in the EU, accounting for 7% of the 
EU’s industrial production. With annual EU chemicals sales of EUR 507 billion20, the sector 
comprises over 28 000 companies and it directly employs around 1.2 million people as well as 
generating additional estimated 3.6 million indirect jobs. SMEs account for around 96% of the 
number of companies in the sector21, approximately one third of the direct employment and 
one  third  of  the  sector's  value-added.  The  EU  chemical  sector  generated  a  value-added  of 
approximately  EUR  115  billion22  in  2014  representing  about  0.8%  of  EU  GDP.  In  2016, 
extra-EU  chemicals  exports  amounted  to  EUR  146.2  billion  and  extra-EU  imports  reached 
EUR 99 billion (the EU chemicals trade surplus outside the EU being valued at EUR 47.2).23 
In 2017, there was an increase in both exports and imports compared to 2016 (+ 6.5% and + 
8.3%).24  

In  terms  of  chemicals  sales,  the  EU  chemicals  industry  represented  in  2016  15.1%  of  the 
global market, behind China (39.6%) ahead of the United States (14.2%)25. EU chemical sales 
increased  by  more  than  50%  in  20  years,  while  its  world  market  share  halved  (down  from 
32.5% in 1996 to 15.1% in 2016) due to strong chemical demand growth in China, and other 

18 CCA1 Study p. 26 
19  CCA  Study  p.  7  quoting  Eurostat,  Structural  Business  Statistics,  Annual  detailed  statistics  on  industry, 
(sbs_na_ind), September 2015 
20 CEFIC Facts and Figures Report, CEFIC, 2017, p. 5 
21 CCA1 Study, p. 27 
22 Eurostat 2014 figure for NACE 20 
23 CEFIC Facts and Figures Report, CEFIC, 2017, p.15 
24 Monthly summary of the Chemicals Trends Report; CEFIC; 20 April 2018 
25 CEFIC Facts and Figures Report, CEFIC, 2017, p. 8 

13 

 
 
                                                 
emerging countries and low growth in Europe and North America, where Europe sells most of 
its chemicals.26 

The main competitive advantage of the EU chemicals manufacturing industry is the high level 
of technological development, skilled workforce and strong research base. The EU chemicals 
industry is one of the most research and development intensive manufacturing sectors within 
advanced economies (behind US and China only). As an input provider for other industries, 
the chemicals  industry  is also considered to  be at the forefront  of innovation and a solution 
provider  for  many  societal  and  environmental  challenges,  with  chemical  technological 
breakthroughs spilling over its downstream sectors. 

The total sold production of chemicals, including pharmaceuticals in the EU in terms of value 
increased  moderately  from  2007  to  2016  with  an  average  annual  growth  of  0.6%27.  The 
production of industrial chemicals in the EU-28, increased each year between 2004 and 2007, 
rising overall by 4.5 % to peak at 371 million tonnes in 2007. The EU chemicals industry was 
strongly  affected  by  the  economic  and  financial  crisis  of  2007-2009.  In  2009,  total  sales 
revenue in the EU chemicals sector lost more than one fifth of its original value compared to 
200828.  The  recovery  trend  started  in  2010  and  peaked  in  2012  before  declining  slightly  in 
line with the global economy. It remained relatively stable during the period 2013–2016 but, 
in production terms, still 40–50 million tonnes below the pre-crisis peak in 2007.29 In 2017, 
and especially if compared to the 2012-2016 period, the EU chemical industry resumed strong 
growth (+7.9%)30 which continued in first quarter of 201831.   

2.3  Baseline 

This  is  a  first  comprehensive  and  cross-cutting  assessment  of  the  EU  chemicals  legislation 
over  its  50  years  of  existence  and  the  progress  made  towards  the  achievement  of  its  core 
objectives. There was no pre-existing assessment that could have been used as a baseline. 

The  wide  scope  of  the  Fitness  Check  and  the  selective  focus  on  the  hazard  and  risk 
assessment and management elements, together with the data limitations and the continuous 
evolution of EU chemicals legislation led to using for the assessment purposes a number of 
different points of reference.   

For the assessment of the effectiveness the following points of reference were used: 

  Achieving human health and environmental protection was measured by looking at the 
achieved  exposure  reductions  since  1970s 
implementation  of  risk 
management measures such as bans, restrictions, emission limits, concentration limits, 
etc. In this regard, a range of different timeframes were considered thus reflecting the 
fact that different pieces of legislation were adopted at different moments in time (see 

through 

international 

26 Ibidem 
27  Eurostat,  Production  and 
explained/index.php/Production_and_international_trade_in_chemicals 
28 CEFIC Facts and Figures Report, CEFIC, 2017, p. 11 
29  Eurostat  Chemicals  production  and  consumption 
explained/index.php/Chemicals_production_and_consumption_statistics 
30 Monthly summary of the Chemicals Trends Report; CEFIC; 20 April 2018  
31 Monthly summary of the Chemicals Trends Report; CEFIC; 2 July 2018 

trade 

in  chemicals  http://ec.europa.eu/eurostat/statistics-

statistics,  http://ec.europa.eu/eurostat/statistics-

14 

 
 
                                                 
 

Annex 4 Table 2). The ‘present’ (at the time the studies were undertaken i.e. between 
2015-2017) was also a frequently used reference point for assessing the effectiveness 
of  certain  processes  and  aspects  of  the  EU  framework  of  chemical  legislation  (e.g. 
communication of chemical hazards and risks to consumers and workers). In terms of 
on-going exposures and predicted future health and environmental impacts e.g. future 
cancer fatalities linked to past, present and future exposures, the timeframes used went 
as far as 2100. 
In terms of meeting the internal market objective,  the most practical way to measure 
change was the level of harmonisation and the growth in intra-EU trade of chemicals. 
Although  there  is  good  data  on  trade,  it  is  difficult  to  know  what  proportion  of  the 
growth  in  intra-EU  trade  is  due  to  chemicals  legislation  versus  other  market  forces. 
Trade  was  used  as  a  performance  indicator  but  this  was  not  explicitly  compared  to 
what  might  have  happened  in  the  absence  of  EU  chemicals  legislation  given  the 
difficulty of estimating what this baseline might have been. The timeframe considered 
for this part of the assessment was 2006-2016.   

  Eurostat data on the volumes of hazardous chemicals produced and consumed in the 
EU  during  the  2004-2016  period  was  used  to  provide  a  rather  general  point  of 
reference  for  assessing  the  progress  made  in  terms  of  substitution  of  the  most 
hazardous  chemicals.  However,  lack  of  clear  link  between  competitiveness  and 
innovativeness  and  the  EU  regulatory  intervention,  as  well  as  lack  of  specific 
performance criteria or meaningful points of reference made the assessment difficult.   

The coherence of the EU chemicals legislation was assessed by comparing different pieces of 
legislation e.g. are the cut-off criteria under the Plant Protection Products Regulation coherent 
with the cut-off criteria set out in the Biocidal Products Regulation.  

For the assessment of costs and benefits, setting a baseline reflecting what would have been 
the legislation in place in Member State in the absence of the EU legislation since 1970s was 
not possible. Therefore, a baseline of no legislation in place at the EU or Member State level 
was used, even though such an assumption also seems hypothetical. For both cost and benefit 
assessments, the ‘zero counterfactual’ baseline was used except where the costs of transition 
from older EU legislation to current EU legislation were assessed (for the CLP Regulation). In 
this  case,  the  counterfactual  used  for  regulatory  costs  was  the  pre-existing  legislation.  The 
assessed costs represent therefore total costs and not the additional costs of implementing EU 
legislation  i.e.  costs  above  and  beyond  the  costs  of  assumed  Member  State  legislation  that 
might have already been in place.  

Even though the ‘zero counterfactual’ baseline was used in a consistent way, cost and benefit 
figures  used  are  difficult  to  compare  because  of  the  timelines  not  lining  up.  As  explained 
above the benefit assessment was backwards looking, i.e. what are the specific exposure level 
reductions  that  we  can  observe  'today’  that  can  be  reasonably  attributable  to  the  pieces  of 
legislation within the scope of this Fitness Check and/or other pieces of legislation considered 
as chemicals related. The cost assessment was limited in time (2004-2016 period). It does not 
look at what were the costs to achieve the specific exposure level reductions. It looks at what 
were  the  costs  that  specific  sub-sectors  of  the  chemicals  industry  had  to  bear  in  order  to 
comply with the legislation existing at that time.  

15 

 
 
 
 
 
3  STATE OF PLAY 

This  section  describes  the  state  of  play  of  the  EU  chemicals  legislation  and  the  factors 
affecting its implementation and enforcement. The following conclusions should be seen as a 
collection of issues identified under the Fitness Check and related evaluations, without being 
complete for each of the pieces of legislation within its scope. Moreover, it should be noted 
that under a number of pieces of the EU chemicals legislation Member States are not required 
to report information on enforcement or information provided is of poor quality. This was a 
significant obstacle for the assessment carried out for the purposes of this Fitness Check. The 
situation  is  however  expected  to  improve  as  several  of  the  individual  pieces  of  legislation 
within the scope of this Fitness Check are currently undergoing their own evaluations (see the 
list  of  ongoing  evaluation  in  Annex  4  Table  4).  The  follow  up  to  the  Fitness  Check  of 
monitoring  and  reporting  of  environmental  policy  will  also  contribute  to  improving  the 
current state of knowledge.32  

3.1  Implementation of the EU chemicals legislation  

3.1.1  Main actors and roles of each  

The  implementation  of  the  EU  chemicals  legislation  relies  increasingly  on  European 
harmonised  processes  in  which  Member  States  alone  or  in  cooperation  with  others  and  the 
Commission  play  important  roles.  The  Commission  has  been  granted  delegated  and 
implementing  powers,  the  latter  being  executed  via comitology.  Approximately  20  different 
committees assist the Commission in the chemicals legislation area.33  

Member  States  are  responsible  for  the  correct  application  of  the  acquis  and  the  timely  and 
correct  transposition  of  Directives.  Regulations  do  not  need  to  be  transposed  i.e.  they  are 
directly applicable and legally binding across the EU. In the area of chemicals legislation, the 
use  of  Regulations  over  Directives  has  increased  over  the  past  10-20  years.  Directives  are 
mainly used in the occupational safety and health (OSH) legislation and environmental policy 
(water and waste) areas. For the OSH legislation this reflects the willingness to provide on the 
one  hand  a  level  playing  field  for  business  operating  within  the  internal  market  and  on  the 
other,  to  leave  room  for  Member  States  to  adopt  more  stringent  protective  measures  when 
transposing  EU  Directives  into  national  law.  For  environmental  policies,  this  allows  taking 
into account the diversity of environmental situations in the various regions of the EU.  

The implementation of the EU chemicals legislation relies also on the activities of different 
EU agencies (collection of data, scientific opinions, guidance, helpdesks etc.) such as ECHA 
or EFSA, and scientific committees providing scientific opinions.  

3.1.2  State of play  
The EU chemicals legislation is relatively mature (2nd or 3rd generation). Some transposition 
issues related to chemicals legislation (hazard/risk assessment and management aspects) have 
occurred  in  the  past  but  the  great  majority  of  these  have  been  identified  and  resolved  since 

32 “Actions to streamline Environmental Reporting” COM (2017) 312 
33 Report from the Commission on the working of Committees during 2016 (COM(2017) 594 final; 16 October 
2017; SWD(2017) 337 final) 

16 

 
 
                                                 
then.  Moreover,  the  increasing  replacement  of  Directives  by  Regulations  has  contributed  to 
this.  

Certain stakeholder groups have expressed concern about the Commission's capacity to make 
risk management decisions in a timely manner. Particular areas of concern include the review 
programme  for  the  approval  of  existing  active  substances  under  the  Biocides  Regulation 
which is closely interlinked with Member States' capacity to carry out assessments, and up in 
the chain linked to the capacity of industry to deliver good quality dossiers, and authorisation 
of the use of recycled plastics in food contact materials34.  

3.2  Enforcement of the EU chemicals legislation  

3.2.1  Main actors and roles of each  

The Member States, EU Agencies and the Commission all play a role in enforcement.  

The  Member  States  have  the  legal  powers  and  obligation  to  enforce  against  duty  holders. 
Enforcement  activities  cover  all  activities  aimed  at  promoting  compliance  and  achieving 
general and specific legal objectives e.g. allowing free movement of goods, lowering risks to 
safety, health and the environment, etc. These activities may include enforcement activities in 
a  broader  sense  such  as  providing  information,  guidance  and  prevention  or  in  a  narrower 
sense such as data collection and analysis, inspections, warnings, improvement notices, fines, 
prosecutions, legal actions in case of infringement etc.  

The Commission's enforcement role is to check the proper application of the legislation. This 
includes  the  resort  to  formal  infringement  procedures  e.g.  in  case  of  non-conformity  of 
national  transposition  law  with  EU  directives  or  incorrect  application  of  the  EU  law.  The 
Commission  also  provides  assistance  to  national  authorities  through  guidance  documents, 
clarifications  on  interpretation  of  legal  provisions,  etc.  Some  pieces  of  legislation  delegated 
certain 'enforcement powers' to ECHA or EFSA, for example, in the case of risk assessment 
dossier  evaluation.  Guidance  to  assist  national  authorities  and  industry  has  improved  the 
clarity and consistency of interpretation of legal requirements. National helpdesks for CLP co-
operate through the ECHA Helpnet35 to support companies in understanding their obligations. 
Although  much  still  needs  to  be  done,  networks  such  as  the  FORUM36  and  RAPEX37  and 
other  legislation  specific  enforcement  networks  have  significantly  contributed  to  improved 
coherence of enforcement.     

34 The EU Strategy for Plastics SWD(2018) 16 final; 16 January 2018; p. 40 
35 The HelpNet is a network made up of ECHA and the national BPR, CLP and REACH helpdesks. The network 
was  created  to  improve  cooperation  on  issues  of  common  interest.  The  benefits  of  this  cooperation  are  the 
achievement  of  a  common  understanding  on  the  legal  requirements  under  the  BPR,  CLP  and  REACH 
regulations and the provision of consistent and harmonised advice to stakeholders. For more information please 
visit https://echa.europa.eu/about-us/partners-and-networks/helpnet 
36 The Forum for Exchange of Information on Enforcement is an ECHA body which coordinates a network of 
authorities responsible for the enforcement of REACH, the CLP and PIC regulations in the EU, Norway, Iceland 
and Liechtenstein. 
37  The  Rapid  Alert  System  enables  quick  exchange  of  information  between  31  European  countries  and  the 
European Commission about dangerous non-food products posing a risk to health and safety of consumers. 

17 

 
 
                                                 
3.2.2  State of play  

The Member States have the legal powers to enforce against duty holders. At Member State 
level,  resource  (both  financial  and  human)  capacity  and  expertise  constraints,  particularly 
following the financial crisis, are resulting in a number of enforcement challenges: 

  Capacity  of  national  competent  authorities  to  conduct  the  necessary  market 
surveillance  activities  in  respect  to  consumer  goods.  The  General  Product  Safety 
Directive  (GPSD)  created  a  horizontal  framework  ensuring  the  safety  of  consumer 
products. To this end, it sets out a number of obligations for manufacturers, importers 
and  distributors  as  well  as  certain  obligations  for  Member  States  as  regards  the 
organisation  of  market  surveillance.  The  GPSD  also  established  a  network  of 
authorities  of  the  Member  States  competent  for  product  safety  aimed  at  facilitating 
operational collaboration on market surveillance and other enforcement activities. The 
GPSD  applies  to  all  consumer  products  including  the  harmonised  sectors  like  toys, 
cosmetics,  etc.,  in  so  far  as  the  relevant  harmonisation  legislation  has  not  itself 
provided  for  specific  rules  with  regards  to  specific  safety  aspects.  While  the  GPSD 
contains an obligation for Member States to take part in the cooperation mechanism, 
the  performance  of  the  obligations  it  imposes  on  Member  States  to  organise  and 
perform  market  surveillance  depends  on  the  resources  available.  For  this  reason 
differences in the various Member States still continue to persist, leading to a different 
level of protection and enforcement within the EU.38  
In  the  case  of  plant  protection  products,  even  though  controls  on  retailers  were 
reported  to  be  generally  satisfactory,  the  majority  of  Member  States  do  not  conduct 
controls on plant protection products stated to be for use in other Member States or in 
non-European  Union  countries.  This  weakness  in  control  systems  can  be  easily 
exploited to place non-compliant products on the market.39  

 

  Capacity  to  undertake  routine  inspections  and  other  compliance  and  enforcement 

activities, including monitoring and reporting.  

  For  example,  the  need  to  invest  additional  resources  on  enforcement  activities  is 
recognised in order to ensure that no biocidal product is illegally placed on the market 
at national level and that these products are properly labelled.40 

  Regarding  the  Toy  Safety  Directive,  Member  States  considered  that  the  low 
consistency of national approaches to enforcement (both in terms of the number and 
the  type  of  control  procedures)  creates  a  trade  barrier.  Limited  testing  capacity  of 
some Member States was also deplored.41  

  Another example is non-harmonised food contact materials (FCMs) – i.e. specific food 
contact  materials  such  as  inks,  adhesives,  or  paper  for  which  at  EU  level  no 
harmonised rules exist42. Member States highlighted the lack of resources needed for 
controls (personnel for the inspections, analytical equipment, facilities, etc.). They also 

38 'The Goods Package: Reinforcing trust in the single market'; SWD(2017) 469 final; 19 December 2017; p. 11 
39  DG  Health  and  Food  Safety  'Overview  Report:  controls  on  the  marketing  and  Use  of  Plant  Protection 
Products'; 2017 
40 Report from the Commission to the European Parliament and the Council on the sustainable use of biocides 17 
March 2017 COM(2016)151 
41 Evaluation of Directive 2009/48/EC on the Safety of Toys; Final report; December 2015 
42 https://ec.europa.eu/food/safety/chemical_safety/food_contact_materials/non_harmonised_en 

18 

 
 
                                                 
reported that local inspection is not adequate for checking compliance with a supply 
chain spread throughout the world.43   

  Regarding online chemicals sales, several enforcement surveys show that various non-
authorised  chemicals  and related products are increasingly being offered for sale via 
the Internet. As chemicals legislation does not distinguish between different types of 
trade,  all  provisions  regulating  chemicals  apply  in  principle  also  to  Internet  trade. 
Currently,  however,  access  to  websites  and  relevant  information  on  transactions, 
vendors  or  service  providers  for  monitoring  authorities  is  difficult  and  therefore 
hampers their investigations.44 

Verification  of  compliance  with  and  enforcement  of  chemicals  legislation  is  in  many  cases 
complex and resource-intensive. Some of the differences in the level of enforcement are due 
to differences in the resources allocated and made available by Member States. Other factors, 
leading  to  non-uniform  application  of  the  EU  law  include  the  national  control  set  ups 
(planning  and  frequency  of  controls,  number  of  inspectors,  training  and  other  professional 
qualifications, etc.), differences in the interpretation of the EU law, differences in or lack of 
standards,  lack  of  harmonised  requirements  and  guidelines,  etc.  The  following  specific 
examples illustrate these observations:  

  Differences  in  administrative  organisation  of  Member  States  create  differences 
regarding  the  frequency  of  controls  and  inspections.  These  differences  are  notable 
regarding  in  particular  the  occupational  safety  and  health  (OSH)  legislation  and  the 
CLP Regulation.  

  Different  interpretation  by  Member  States  of  the  legislation  and  lack  of  guidance 
documents  and/or  harmonised  analytical  methods 
the 
implementation  of  the  EU  chemicals  legislation.  This  was  indicated  in  particular  for 
the  CLP,  the  FCMs,  the  Plant  Protection  Products  Regulations,  and  the  Toy  Safety 
Directive.  

impact 

testing 

for 

Even  though  the  principle  of  mutual  recognition  is  one  of  the  means  of  ensuring  the  free 
movement of goods within the EU, whether it is effective in doing so, depends on if and how 
Member States apply it. In cases where there is an absence of mutual recognition, this leads to 
duplication  of  efforts  between  Member  States  and  exacerbates  the  existing  resource 
limitations.  Because  mutual  recognition  is  currently  underutilised  for  plant  protection 
products  authorisation,  risk  assessments  are  sometimes  partially  or  fully  repeated  by  other 
Member States thus creating additional costs. The main reasons for this are related to lack of 
information  on  how  the  first  Member  State  reached  its  conclusion,  leading  to  a  lack  of 
confidence.  The  other  major  reason  is  the  age  of  the  data,  noting  that  some  time  may  have 
passed between the first and subsequent assessments.  

Where technical standards or detailed harmonised requirements are lacking or are incomplete, 
or  where  technical  standards  do  exist  but  there  is  no  EU-wide  shared  methodology  for 
assessing them, this can undermine the quality and completeness of the exposure assessments 

43  Joint  Research  Centre  (JRC),  Non-harmonised  food  contact  materials  in  the  EU:  regulatory  and  market 
situation, 2016, p. 111 
44 Erdmann et al (2016): Project e‐commerce II, Final Report to the Chemical Legislation European Enforcement 
Network (CLEEN), Germany. 

19 

 
 
                                                 
that  are  needed  for  conducting  the required  risk  assessments.  This  issue  was  highlighted  by 
several  Member  States  regarding  the  'safety'  (i.e.  risk)  assessments  of  toys  and  their 
constituent substances, as well as assessing health risks associated with their use.45 In general, 
the performance of risk assessment is easier to quality control where there is a requirement to 
not only document it but also communicate its outcome to the public authorities.   

45 Member States' report on the Toy Safety Directive 2015 

20 

 
 
 
 
                                                 
4  METHODOLOGY 

4.1  Description of methodology: quantification and data collection 

A roadmap46 was published in 2015 presenting the scope and the key evaluation questions to 
be addressed by the Fitness Check, as well as a consultation strategy to ensure stakeholders' 
engagement in the process (see below and the Annex 2). The Fitness Check was accompanied 
by an interservice steering group covering all Commission services in charge of the legislation 
under scrutiny plus horizontal services. 

Priorities  for  assessment  were  established  on  the  basis  of  the  main  areas  of  improvement 
identified by the key studies supporting the Fitness Check47, considering the concerns raised 
by stakeholders. 

4.1.1  Studies  

Two  key  studies  and  two  related  studies,  carried  out  by  external  consultants  for  the 
Commission, provide an important part of the evidence base for the Fitness Check.48   

A. 

Complementarity of the Fitness Check core studies 

The 1st Fitness Check study49 (1st FC Study) was completed in January 2017. It focuses on the 
CLP  Regulation  and  related  legislation  governing  hazard  identification,  communication  and 
risk management of chemicals. This includes an assessment of costs and benefits associated 
with the CLP Regulation. The on going costs of the CLP are estimated as ‘present day’ costs 
generated  at  the  time  of  the  study  (2015-2016)  using  a ‘zero  counterfactual’  as  the point  of 
reference i.e. against a situation where there is no legislation in place at Member State or the 
EU level. The transition costs from the previsious Dangerous Substances Directive (DSD) and 
Dangerous Preparations Directive (DPD) to the CLP Regulation cover the time period from 
2009  (when  the  CLP  first  came  into  force)  to  the  2015  deadline  for  meeting  the  CLP 
requirements  applicable  to  mixtures.  The  (partial)  assessment  of  human  health  and 
environmental benefits of classification, labelling and packaging of chemicals was examined 
across a timeframe of 2000-2016. This allowed a comparison between the partial estimation 
of  benefits  accrued  under  the  pre-CLP  legislative  situation  (the  DSD  and  the  DPD)  against 
partial estimation of benefits accrued following implementation of the  CLP Regulation. The 
benefits assessment was also done using a zero counterfactual baseline. 
The  1st  FC  Study  was  complemented  by  a  second  study50  (FC+  study)  completed  in 
November 2017. Its focus was pieces of legislation that operate independently of the CLP for 
chemical hazard identification and classification and pieces of legislation where specific risk 
assessment  procedures  form  the  core  part  of  the  risk  management  process  (this  was  not 

46 http://ec.europa.eu/smart-regulation/roadmaps/docs/2015_grow_050_refit_chemicals_outside_reach_en.pdf 
47 See Section D.5 of the Fitness Check roadmap 
48 For more information regarding the studies please see Section 2.3 Baseline as well as Annex 3 and Annex 4 
(Table 1, Table 2, Table 3 and study ‘fiches’) 
49  Study  on  the  regulatory  fitness  of  the  legislative  framework  governing  the  risk  management  of  chemicals 
(excluding REACH), in particular the CLP Regulation and related legislation 
50 Study supporting the Fitness Check on the most relevant chemicals legislation 

21 

 
 
                                                 
covered  by  the  1st  FC  Study).  For  the  great  majority  of  assessment  aspects,  including  the 
analysis of cost drivers, the time reference of the FC+ Study was the ‘present day’ situation 
i.e. situation at the time the study was undertaken (2017). The cost driver analysis was done 
using a zero counterfactual (i.e. no chemicals legislation in place at Member State and the EU 
level) as the point of reference. 

Because in many cases, the EU chemicals legislation is based on the use of both generic and 
specific  risk  assessment  and  more  or  less  direct  link  to  the  CLP  Regulation  (see  Annex  4 
Table  1),  a  number  of  pieces  of  legislation  were  covered  by  both  core  studies.  Examples 
include the Toy Safety Directive, the Cosmetic Products Regulation, the Plant Protection and 
the Biocidal Products Regulations, the Industrial Emissions Directive, the Water Framework 
Directive, the  Detergents Regulation, the Food Contact Materials  Regulation (Table 1).  The 
REACH Annex XIII and the CLP Regulation were however exclusively covered by the 1st FC 
study.  

In line with the Fitness Check methodology, the studies respond to the evaluation criteria and 
evaluation  questions  from  the  roadmap,  while  also  providing  a  more  detailed  analysis  of 
relevant themes through study tasks and case studies.  

B.  Additional Fitness Check supporting studies  

The findings of the two core Fitness Check studies were complemented by a cumulative cost 
assessment  of  the  chemical  industry  (CCA1)  and  a  study  on  the  cumulative  health  and 
environmental benefits of chemicals legislation (CuBA Study). The CCA1 study provides an 
estimate  of  total  regulatory  costs  (i.e.  it  uses  a  zero  counterfactual  as  a  point  of  reference 
which  assumes  no  chemicals  legislation  at  Member  State  level  in  the  absence  of  EU 
chemicals  legislation)  of  the  most  relevant  EU  legislation  with  a  bearing  on  the  chemical 
industry (excluding downstream sectors) during the period 2004-2014.  

The  CuBA  study  draws  together  a  large  body  of  evidence  on  the  health  and  environmental 
improvements  achieved  since  1970s  as  a  result  of  hazardous  chemical  exposure  reductions 
linked  to  EU  chemicals  legislation.  The  CuBA  study  also  assesses  the  health  and 
environmental impacts and costs associated with on-going exposures to chemical risks. Again, 
the benefits are estimated using a zero counterfactual as the point of reference. 

C.  Methodology, time and legal scope, and topics covered  

The  main  methodologies  applied  in  the  context  of  the  abovementioned  studies  can  be 
described as follows: 

  Development  of  an  intervention  logic  underpinning  the  rationale  for  chemicals 
legislation  and  the  CLP  Regulation  more  specifically,  including  legal  mapping  to 
identify  relevant  legislation  and  specific  provisions  within  this.  This  was  then 
supported  by  a  legal  analysis  to  identify  the  nature  of  the  obligations  for  different 
economic operators, how the legislation was implemented in practice, and areas where 
there appeared to be inconsistencies, overlaps and incoherence. 

  A literature review to pull key information from impact assessments, position papers, 
academic and scientific research, papers and reports prepared by the relevant scientific 
bodies, regulatory submissions and other 'grey' literature. 

  Development  of  evaluation  questions  (see  Annex  10)  and  stakeholder  consultation 

activities (see Annex 2). 

22 

 
 
  Case study research, which involved a more in-depth examination of some of the most 
pertinent issues identified as part of initial research (e.g. metals classification and the 
CLP  Regulation,  parallel  hazard  assessments,  persistent,  bioaccumulative  and  toxic 
(PBTs) / very persistent and very Bioaccumulative (vPvBs) substances, carcinogenic, 
mutagenic  or  toxic  for  reproduction  substances  (CMRs),  linkages  between  the  CLP 
and  the  occupational  safety  and  health  (OSH)  legislation  and  several  others),  either 
directly linked to the interface between the CLP and other legislation, the functioning 
of  specific  legislation,  or  examining  tools  or  measures  needed  to  support  the 
legislation. 

  Comparative  analysis  of  approaches  based  on  specific  risk  assessments  and  generic 

risk considerations. 

More generally, the studies have applied the tools set out in the Better Regulation Toolbox51 
in assessing costs and benefits. 

Figure 3 illustrates the time period covered by each of the Fitness Check studies. 

Figure 3 Time period covered by the Fitness Check studies 

Table 1 illustrates the legal scope covered by studies.   

COVERED BY: 

1st FC 
FC+ 
CCA1  
CuBA 

1st FC 
CCA1  
CuBA 

LEGISLATION 
Industrial Emissions Directive 
Water Framework Directive 
Biocidal Products Regulation 
Plant Protection Products Regulation 
Toy Safety Directive 
Cosmetic Products Regulation 
Detergents Regulation 
Food contact materials Regulations 
CLP Regulation 
REACH Annex XIII52 
Inland transport of dangerous goods Directive 
Carcinogens and mutagens at work Directive 
Chemicals Agents Directive 
Young People at Work 

51 http://ec.europa.eu/smart-regulation/guidelines/docs/br_toolbox_en.pdf 
52 CCA1 and CuBA cover entire REACH  

23 

 
 
 
                                                 
Pregnant Workers Directive 
Seveso III Directive 
Waste Framework Directive 
End of Life Vehicles Directive 
Fertilisers Regulation 
Waste shipments Regulation  
EU Ecolabel Regulation 
Pressure equipment Directive 
General Product Safety Directive 
RoHS 2 Directive 
Batteries Directive 
Packaging and Packaging Waste Directive 
Export and import of hazardous chemicals (PIC) Regulation 
POPs Regulation 
Explosives Directive 

Signs at work Directive 

Asbestos Directive 
Urban Waste Water Directive 
Marine Strategy Framework Directive 
Contaminants in food and feed Regulation and Directive  
Drinking Water Directive 
Medical Devices Directives 
Protection of animals used for scientific purposes Directive 
Aerosol dispensers Directive 
Test methods Regulation 
Good Laboratory Practice Directives 
Residues of pesticides Regulation 

1st FC 
FC+ 
CuBA 

FC+ 
CCA1 
CuBA 

1st FC 
CCA1 

FC+  
CuBA 

1st FC 

FC+ 

Table 1 Pieces of legislation covered by the Fitness Check Studies 

Annex  4  Table  1  and  Table  3  provides  more  detailed  information  about  how  the  Fitness 
Check supporting studies cover the topics discussed in the remainder of this document.  

The studies provide evidence for the full scope to a large extent. However, either because of 
methodological challenges and lack of data or peculiarities of this Fitness Check i.e. focusing 
on the framework-wide issues rather than on legislation specific issues, some aspects were not 
assessed in-depth. In order to fill such gaps, other available sources of information were used, 
including  other  REFIT  supporting  studies  or  interim  reports,  EU  Agencies’  and  the 
Commission’s reports, as well as the other recent chemicals related initiatives and actions (see 
Annex 4 Table 3).  

Annex  4  Table  4  provides  a  list  of  finished  or  still  ongoing  individual  evaluations  and  how 
these  different  sources  of  information  were  used  for  the  purposes  of  this  Fitness  Check 
(mainly  concerning  occupational  safety  legislation,  plant  protection  products  legislation, 
detergents and waste legislation). It should be noted however that where there is no specific 
reference  to  these  individual  evaluations,  it  is  either  because  they  were  already  used  and 
refered to in the Fitness Check Studies or because the evaluation has just started and therefore 
evidence is not yet available.  

4.1.2  Data collection and stakeholder consultation 

Given  the  wide  scope  of  the  whole  exercise  and,  in  some  cases,  the  lack  of  data  (costs, 
benefits, enforcement, performance monitoring, etc.) on individual pieces of legislation, this 

24 

 
 
Fitness Check put a particular emphasis on stakeholder and expert input. Therefore, some of 
the  issues  identified  may  require  further  assessment  as  part  of  a  dedicated  evaluation  of  a 
specific piece of legislation, as mentioned above. 
The  stakeholder  consultation  strategy  developed  for  the  purpose  of  this  Fitness  Check53 
comprised an public consultation (from 4 March to 27 May 2016), an SME panel through the 
Enterprise Europe Network (from 30 May to 18 July 2016), targeted interviews, stakeholder 
workshops conducted as part of the two main Fitness Check studies as well as the CCA1 and 
CuBA studies, and two Eurobarometer surveys (see Annex 2 for more details).54  

In line with the consultation strategy, input from a wide range of stakeholders was collected: 

  public  authorities,  notably  competent  authorities  responsible  for  the  implementation 

 

and enforcement activities;  
industry  associations  covering  both  the  chemicals  industry  and  downstream  sectors 
(manufacturers  and  importers  of  chemicals,  distributors  of  substances  and  mixtures, 
formulators); 

  companies  in  both  the  chemicals  industry  and  downstream  sectors,  focusing  in 
particular  on  Small  and  Medium-sized  Enterprises  (SMEs)  (manufacturers  and 
importers of chemicals, distributors of substances and mixtures, formulators);  
  civil society organisations – NGOs (e.g. environmental, health, animal welfare); 
  consumer associations; 
 
  other interested groups such as academics / research institutes; and 
  consumers / workers /citizens. 

trade unions  

The  online  public  consultation  was  conducted  in  English,  German  and  French.  The  SME 
panel and the two Eurobarometer surveys were conducted in all EU languages.  

These  different  consultation  activities  and  tools  allowed  receiving  feedback  from  all 
stakeholder groups. A summary of these views is provided in Annex 2.55 
Information  on  the  Fitness  Check  is  published  on  the  websites  of  DG  GROW56  and  DG 
ENV57.  

4.1.3  Use of findings from studies and stakeholder views for the purposes of this 

Fitness Check  

The two core Fitness Check studies and the two additional Fitness Check studies provide the 
main evidence for the assessment presented in the remainder of this document. The evidence 
that  these  studies  provide  was  used  in  a  combined  and  complementary  way.  Each  study 

for 

strategy 

53  Consultation 
fitness  check  on  chemicals 
the 
http://ec.europa.eu/DocsRoom/documents/17109/attachments/1/translations 
54 Special Eurobarometer 456 November-December 2016 and Special Eurobarometer 468 September-November 
2017 
55 See also 1st FC Study, Annex V 
56 http://ec.europa.eu/growth/sectors/chemicals/ec-support/index_en.htm 
57 http://ec.europa.eu/environment/chemicals/better_regulation/index_en.htm 

(excluding  REACH) 

legislation 

25 

 
 
                                                 
corresponds  to  a  different  evidence  gathering  phase  which  was  followed  by  an  assessment 
phase.  
The  1st  FC  Study  corresponds  to  the  first  evidence-gathering  phase  (March  2015-October 
2016; see Figure 4) which started with the publication of the Roadmap. It was preceded by the 
launch  of  the  CCA1  Study.  The  assessment  done  during  this  phase  was  based  on  desk 
research  and  was  followed  and  complemented  by  an  extensive  stakeholder  consultation 
process. This first phase of the assessment provided useful and meaningful input and allowed 
to identify additional needs in order to cover the full scope of this Fitness Check. 

Figure 4 First evidence gathering phase done for the purposes of the Fitness Check 

The second evidence gathering phase started with the launch of the FC+ Study (see Figure 5). 
Similarly to the 1st FC Study, it also included targeted interviews with stakeholders as well as 
a stakeholder workshop.  

Figure 5 Second phase of the assessment done for the purposes of the Fitness Check 

During  the  assessment  phase  (starting  in  December  2017),  all  the  evidence  and  stakeholder 
input  gathered  went  through  a  thorough  selection  process.  The  purpose  was  to  select  those 
elements that affect (positively or negatively) the functioning of the framework and to identify 
those  aspects  that  were  only  affecting  the  functioning  of  a  specific  piece  of  legislation. 
Therefore, not all of the findings gathered found their way in the final report. This assessment 
phase was also necessary in order to reality check the findings and to ensure that the Fitness 
Check supporting studies were used and combined to their utmost potential.  

Annex  4  (Table  1  and  Table  3)  provides  more  detailed  information  about  how  the  Fitness 
Check supporting studies cover the topics discussed in the remainder of this document.  

4.2  Limitations and robustness of findings 

Given  the  wide  scope  of  the  exercise  and  the  impacts  of  chemicals  legislation,  there  were 
numerous challenges in gathering the data needed to provide a robust evidence base, as well 
as  in  providing  quantitative  estimates  of  impacts.  As  far  as  possible,  data  was  triangulated 
with  evidence  collected  from  multiple  sources  e.g.  literature  review,  qualitative  assessment 
based  on  expert  input  (e.g.  Member  State  Competent  Authorities),  stakeholder  consultation 
etc.  to  provide  as  robust  a  picture  of  the  evidence  as  possible.  Nevertheless,  whilst  some 

26 

 
 
 
 
legislation  and  risk  assessment  processes  are  well  covered by  multiple different  stakeholder 
groups and literature/data sources, other pieces of legislation are less well covered. 

Where  specific  obstacles  and  challenges  were  encountered,  limitations  are  mentioned  and 
explained  in  the  relevant  sections.  The  evidence  and  study  limitations  presented  particular 
challenges with respect to the Fitness Check findings in the following areas: 

  Determining  and  comparing  framework-wide  costs  and  benefits  and,  therefore, 
assessing the proportionality of the EU chemicals legislation at the framework level. 

  Enforcement and implementation of the EU chemicals legislation. 
  Determining  the  actual  significance,  in  practical  terms,  of  some  of  the  coherence 
issues identified. It was beyond the scope and resources of the Fitness Check to seek 
primary evidence in order to test the real life significance of coherence issues flagged 
by one or more stakeholder groups. 

Care  was taken  to  accurately report different opinions and findings while also ensuring that 
the evidence and sources can be traced back and that therefore the reliability and robustness 
are ensured.  

4.2.1  The First Fitness Check Study (‘1st FC Study’) 
The key limitations of the 1st FC Study can be described as follows: 

  The broad scope of the study and the number of pieces of legislation to be considered. 
  The lack of available information on the scale of issues identified  (both positive and 
negative) and the subsequent need to rely on information provided by stakeholders. 
  The limited response received from civil society stakeholders. However, further desk-
based  research  of  published  information  from  NGOs  was  undertaken  to  inform  the 
study. 

  The lack of available data to assist in determining the effectiveness and efficiency of 

the legislative framework (particularly in quantitative terms). 

  The  inability  or  unwillingness  of  companies  to  provide  certain  data  creating 
difficulties in quantifying the impacts of the CLP Regulation and other legislation. 
  The  lack  of  up-to-date  information  regarding  the  effect  of  the  CLP  Regulation  on 

consumer behaviour. 

4.2.2  The Second Fitness Check Study (‘FC+ Study’) 
The key limitations of the FC+ Study can be described as follows: 

  Stakeholders were identified based on their active engagement with specific pieces of 
legislation.  However,  involvement  in  the  study  was  on  a  voluntary  basis.  Therefore, 
those who felt strongly about particular processes or pieces of legislation were more 
likely to take part. To offset this possible limitation stakeholders included regulators, 
industry and NGOs, as well as officers of the European Commission and EU agencies 
responsible for chemicals legislation. 
In  a  limited  number  of  cases  particular  stakeholder  groups  (e.g.  industry,  regulators, 
NGOs)  dominated  the  responses  for  certain  aspects  of  legislation.  The  study  report 
states where this is the case.  

 

  The  stakeholders  engaged,  while  broadly  diverse,  could  still  be  argued  to  be  a 
relatively small sub-set compared to the size and scale of the EU chemicals industry. 

27 

 
 
To offset this limitation the work completed under the FC+ Study included a review of 
the findings of the 1st FC Study to enable a more complete analysis, and evidence was 
sought  wherever  possible  to  back  up  opinions.  Findings  from  the  1st  FC  Study 
(including  its  public  consultation  and  SME  panel)  were  used  to  help  corroborate 
findings in the FC+ Study where appropriate. 

  The available economic data on costs and efficiency reported in a quantitative fashion 
was  very  limited.  Literature  data,  and  two  stakeholder  engagements  were  used  to 
gather  quantitative  and  qualitative  information  on  the  functioning  and  efficiency 
aspects  of  the  risk  assessment  and  risk  management  processes  used  under  the  EU 
legislation. However, it was not possible to provide extensive costed examples related 
to efficiency. 

  The  available  information  on  specific  pieces  of  legislation  varied,  with  some 
legislation  and  risk  assessment  processes  well  covered  by  multiple  different 
stakeholder groups and literature/data sources. Other pieces of legislation were not as 
well covered and the analysis relied more on policy guidance documents and review of 
the legislation to ascertain how the processes function and what potential issues may 
exist (see Annex 3 Table 6 for a summary of data availability per piece of legislation).  
  The FC+ Study also undertook a semi-quantitative assessment of the key cost drivers 

for six pieces of legislation.58  

4.2.3  The  Study  on  the  Cumualative  Health  and  Environmental  Benefits  of 

Chemicals Legislation (‘CuBA Study’) 

With respect to the CuBA Study, key limitations can be described as follows: 

 

  The  study  focused  on  “cumulative”  health  and  environmental  benefits  delivered 
through the cumulative effect (accumulation) of various different pieces of legislation, 
each addressing a risk or group of risks. It did not, however, seek to attribute specific 
impacts to every individual piece of legislation. The study presents a combination of 
qualitative,  quantitative  and  monetary  estimates  of  these  benefits.  Neither  the  socio-
economic benefits of chemicals legislation (in terms of accelerated innovation) nor of 
chemicals themselves (facilitating efficiencies or technologies for example) were part 
of the study scope.   
It is important to note that this is the first time a study on this scale and scope has been 
attempted.  The  work  is  based  on  drawing  together  existing  information,  though  a 
number  of  calculations/interpretations  were  done  to  derive  some  of  the  quantitative 
figures  in  the  report.  In  some  cases  the  estimates  provided  are  associated  with 
significant uncertainties. These are discussed at length, but are provided as a starting 
point  for  additional  research  and  discussion.  Where  benefits  relate  to  productivity 
and/or  healthcare  treatment  (“direct  financial”)  costs,  these  are  compared  to  GDP  in 
national  accounts  to  provide  context  on  their  significance;  others  reflect  “personal 
valuation”  (willingness  to  pay  to  avoid  certain  medical  ailments  or  for  ecosystem 
services, for example). These costs are no less real than those that are linked to GDP: 

58  The  Plant  Protection  Products  Regulation,  the  Residues  of  Pesticides  Regulation,  the  Biocidal  Products 
Regulation, the Medical Devices Directive, the Toy Safety Directive, and the Cosmetic Products Regulation. 

28 

 
 
                                                 
society  places  a  high  value  on  having  a  long,  healthy  and  fulfilled  life.  Where 
appropriate, they are expressed in monetary terms. 

4.2.4  The Cumulative Costs Assessment Study (‘CCA1 Study’) 
The  cost  estimates  provided  by  the  CCA1  Study  have  to  be  treated  with  caution  due  to 
differences in scope and in the methodology applied. Firstly, the period covered by the CCA1 
Study  i.e.  2004-2014,  only  partially  corresponds  to  the  one  covered  by  this  Fitness  Check. 
Secondly, the estimated costs relate only to certain subsectors of the EU chemicals industry 
and  not  to  all  the  downstream  sectors  that  are  also  considered  by  this  Fitness  Check. 
Furthermore, regulatory costs were estimated and included in the overall CCA1 estimates for 
several pieces of legislation that are not in the scope of this Fitness Check while, at the same 
time, several other pieces of legislation although within the scope of this Fitness Check, were 
not  covered.  Finally,  the  sample  size  and  coverage  did  not  allow  for  statistically  accurate 
analysis  and  conclusions.  Therefore,  additional  cost  elements  were  gathered  where  possible 
and qualitative assessment is presented instead.  

29 

 
 
 
 
ANSWERS TO THE EVALUATION QUESTIONS  

The following sections answer the evaluation questions concerning the five central evaluation 
criteria  of  effectiveness,  efficiency,  relevance,  coherence  and  EU  added  value.  A  more 
detailed  analysis  of  effectiveness,  efficiency  and  coherence  related  issues  can  be  found  in 
annex  (Annex  5,  Annex  6  and  Annex  7  respectively)  as  well  as  in  the  underlying  Fitness 
Check studies.  

Many of the factors that affect the effectiveness of EU chemicals legislation are also closely 
linked  to  its  efficiency,  coherence,  relevance  and  implementation.  Issues  identified  in  the 
effectiveness  section  are,  therefore,  sometimes  referred  to  in  other  sections  where  they  are 
evaluated in more detail.  

5  EFFECTIVENESS  

5.1  Evaluation question: to what extent does the EU legislative framework 

for the risk management of chemicals meet its objectives?  

This section analyses the progress made towards achieving the three core objectives that are 
shared by nearly all pieces of EU chemicals legislation:  

1.  Ensuring  a  high  level  of  protection  of  human  health  from  the  adverse  effects  of 

hazardous chemicals. 

2.  Ensuring  a  high  level  of  protection  of  the  environment  from  the  adverse  effects  of 

hazardous chemicals.  

3.  Supporting  the  efficient  functioning  of  the  internal  market  for  chemicals  and 

enhancing the competitiveness and innovation of EU industry and business.   

As  the  first  two  objectives  are  rather  different  in  their  nature  from  the  third  objective  and, 
therefore, have a different set of performance indicators, they are assessed separately. 

5.1.1  The objectives of high level of protection of human health and environment 

A. 

What's the issue? 

EU chemicals legislation aims to achieve a high level of protection of human health and the 
environment by minimising exposures to hazardous chemicals and by stimulating substitution 
of hazardous substances by less hazardous chemicals (or alternative non-chemical solutions). 
The effectiveness of the EU chemicals acquis in achieving these objectives can be assessed by 
analysing the trends in: 

 
 
 

the production and use of hazardous substances; 
the human and environmental exposures to hazardous chemicals; and, ultimately 
the  impacts  in  the  form  of  the  main  health  and  environmental  impact  parameters 
associated with exposures to hazardous chemicals, such as trends in the EU incidence 
rates  of  certain  human  diseases,  trends  in  animal  population  levels,  trends  in  eco-
system health/resilience. 

B. 

What are the findings? 

Conclusions 

30 

 
 
For the specific  hazardous substances that have been  targeted over the last  3-4 decades, the 
EU  chemicals  acquis  has  been  quite  effective  in  reducing  and  minimising  human  and 
environmental exposures. This includes some notable reductions in exposures to problematic 
substances such as lead, mercury, benzene, asbestos, polychlorinated biphenyls (PCBs), and a 
range of other chemicals with carcinogenic, mutagenic or toxic for reproduction (CMR) and 
persistent,  bioaccumulative  and  toxic  (PBT)  /  very  persistent  and  very  bioaccumulative 
(vPvB)  hazard  characteristics.  However,  a  range  of  on-going  and  emerging  health  and 
environmental  concerns  related  to  the  exposure  to  hazardous  chemicals  remain  and  require 
further attention.  

The analysis finds little evidence of a general shift towards production and/or consumption of 
less  hazardous  substances  although  there  are  some  preliminary  positive  indications  of 
substitution  with  respect  to  substances  hazardous  to  the  environment.  This  may,  in  part, 
reflect  the  effectiveness  of  risk  management  measures  in  reducing  exposures  and  risks, 
therefore  reducing  the  incentive  to  substitute  to  less  hazardous  substances.  Essentially,  the 
share of industrial chemicals hazardous to health and the environment in the total chemicals 
production has remained relatively unchanged over the last decade.  

Trends in endpoint human health and environmental impacts (cancers, reproductive diseases, 
respiratory  sensitization,  insect  and  bird  populations,  etc.)  point  to  a  mixed  picture  but  are 
difficult to use as direct indicators of chemicals policy performance because of the attribution 
challenge.  Most  of  these  trends  are  linked  to  multiple  causal  factors  of  which  exposure  to 
hazardous  chemicals  might  be  just  one.  Moreover,  data  is  generated,  including  through  the 
regulatory  framework,  based  on  substance-by-substance  approach. It is  therefore  difficult  to 
use it to give a picture of the overall level of protection of human health and the environment. 
The  current  approach  and  indicators  used  in  monitoring  and  assessing  human  health  and 
environmental  impacts  could  benefit  from  being  more  holistic.  On  a  positive  note,  the 
reduction  in  the  incidence  rates  of  workplace-related  cancers  and  in  lead-related  health 
impacts are good examples of improvements that can be linked to the EU interventions. There 
are, however, a few trends such as breast cancer, certain reproductive diseases, and decline of 
insect and bird populations that are a cause for concern. Further research and a strengthened 
science-policy interface are needed.  

1) 

Production and consumption of hazardous substances  

Trends  in  the  production  and  consumption  of  hazardous  substances,  either  expressed  in 
absolute terms or relative to overall chemicals production and consumption, are one potential 
indicator of the substitution of hazardous substances by less hazardous substances. While not 
shared by all the pieces of legislation within the scope, it remains one of the goals of some of 
them  e.g.  the  Plant  Protection  Products  Regulation  and  the  Biocidal  Products  Regulation. 
Eurostat  has  been  producing  since  2014  relevant  data  sets  regarding  substitution  trends  for 
industrial chemicals (please see also Annex 5 Section 5.1.1 A)).  
The findings of the latest analysis59 for EU-28 published in December 2017 are:  

  The trend in the production of chemicals hazardous to health60 and the environment61 
followed the trend for the overall chemicals production (Figure 6), reaching a peak in 

59 http://ec.europa.eu/eurostat/statistics-explained/index.php/Chemicals_production_and_consumption_statistics 

31 

 
 
                                                 
2007, after which there was a significant decline in production during the financial and 
economic crisis in 2008, followed by a strong rebound between 2009 and 2010 and a 
subsequent more stable phase.  

Production of chemicals in the EU [million 
tons per year] 

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Chemicals hazardous to health

Chemicals hazardous to the environment

Total (hazardous and non-hazardous)

Consumption of chemicals in the EU [million 
tons per year] 

400

300

200

100

0

500

400

300

200

100

0

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016

Chemicals hazardous to health

Chemicals hazardous to the environment

Total (hazardous and non-hazardous)

Figure  6  Production  and  consumption  of  chemicals,  EU-28,  2004-2016.  Source:  Eurostat  (online  data  codes: 
env_chmhaz) Note: some chemicals are hazardous to both the environment and human health therefore adding these 

60 Hazardous to health covers the following 5 classes: (1) Harmful to health hazard, (2) Toxic health hazard, (3) 
Very toxic to health hazard, (4) Chronic toxic health hazard, (5) Carcinogenic, mutagenic and reprotixic (CMR) 
health hazard. The indicator on chemicals hazardous to health is a sustainable development indicator within the 
theme for public health. 
61 Hazardous to the environment chemicals covers the following 5 classes: (1) Significant acute environmental 
hazard, (2) Chronic environmental hazard, (3) Moderate chronic environmental hazard, (4) Significant chronic 
environmental  hazard,  (5)  Severe  chronic  environmental  hazard.  This  division  is  based  on  their  hazard  on  the 
aquatic environment 

32 

 
 
 
 
                                                                                                                                                         
total together and subtracting the result from the total production or consumption volume to determine the volume of 
non-hazardous chemicals cannot be done. 

  The  share  of  chemicals  hazardous  to  health  and  the  environment  was  relatively 
unchanged  over  the  period  2004–2016.  The  share  of  chemicals  hazardous  to  the 
environment  fluctuated  between  37%  and  39%,  while  the  share  of  chemicals 
hazardous to health fell from about 66% in 2004 to 62% in 2016.  

The analysis shows substitution of hazardous substances by less hazardous substances has not 
yet occurred to any notable extent. Essentially, the share of industrial chemicals hazardous to 
health  and  the  environment  in  the  total  chemicals  production  has  remained  relatively 
unchanged over last decade. This may, in part, reflect the effectiveness of risk management 
measures in reducing exposures and risks, therefore reducing the incentive to substitute to less 
hazardous  substances.  The  analysis  also  shows  what  might  be  the  beginning  of  a  positive 
substitution trend. The largest overall decrease in EU-28 production between 2004 and 2016 
was recorded for chemicals with severe chronic environmental hazard and for chemicals with 
significant acute environmental hazard (as the production volume was reduced by about 18 % 
for both classes over the period under consideration). This may indicate that the substitution 
for these groups to less hazardous chemicals has started to happen (while it does not seem to 
be  the  case  yet  for  chemicals  hazardous  to  health).  One  could  also  note  that  no  legislation-
specific information is available which could allow the assessment of the pace of substitution 
once such a need is identified and eventually compare across the legislation. These statistics 
do  not  allow  to  link  changes  in  the  share  of  chemicals  hazardous  to  health  and  the 
environment  to  the  EU  intervention.  In  order  to  do  so,  more  in-depth  analysis  would  be 
required.  
Respondents  to  the  public  consultation62  were  asked  to  assign  a  score  of  between  1  (no 
contribution) to 5 (large contribution) to the role of the EU legislative framework in reducing 
the  use  of  hazardous  chemicals  and/or  substitution  with  safer  alternatives.  Scores  assigned 
showed  considerable  variation  among  the  four  groups  of  respondents.  Industry  and  public 
authority  groups63  considered  the  EU  chemicals  framework  to  have  made  the  largest 
contribution  to  a  reduction  in  number  or  use  of  hazardous  chemicals  and/or  an  increase  in 
substitution to safer alternatives. In contrast, NGOs and other civil society organisations were 
considerably less positive. 

2) 

Human and environmental exposures to hazardous chemicals  

There is clear evidence that, where targeted EU policy and regulatory action has been taken, 
human  and  environmental  exposures  to  a  number  of  well-known  individual  hazardous 
chemicals  have  been  successfully  reduced  or  in  many  cases,  minimised.  As  one  example, 
consumer exposure to lead e.g. in petrol, paints, toys, drinking water, etc., has been reduced 
by  an  estimated  89%  in  the  EU  between  1990  and  2011,  following  a  variety  of  risk 
management  measures  implemented  by  Member  States,  at  least  in  part  due  to  EU 

62 1st FC Study, Annex V, p. 149; public consultation Question 23 
63 Weighted scores of 3.4 and 3.5 respectively 

33 

 
 
                                                 
legislation.64  This  has  resulted  in  a  sustained  and  significant  reduction,  on  average,  in 
measured levels of lead in blood65 (see Figure 7).   

200

180

160

140

120

L
100
/
g
μ
80
n

i

l

l

60
e
v
e
40
d
a
20
e
d
o
0
o
1980
B

l

l

1985

1990

1995

2000

2005

2010

2015

Figure  7  Medians  (green  dots)  and  5th  to  95th  interval  of  the  distribution  of  lead  levels  in  the  blood  of  German 
students from 1981 to 2015, along with levels of lead in blood of children from various European cohorts included in 
the  WHO  ENHIS  database  in  grey  (no  known  large  lead  pollution  sources)  and  red  (in  the  vicinity  of  known  lead 
pollution sources). Dotted line represents the threshold implied by the WHO IQ loss model.66  

From the environmental perspective, similar outcomes have been achieved in the EU between 
1990  and  2011  for  a  number  of  heavy  metals  such  as  mercury  (66%  emissions  reduction), 
cadmium (64% emission reduction) and arsenic (78% emissions reduction)67 (see Figure 8). 
Reductions in the concentration of a number of other hazardous chemicals in the environment 
such  as  tributyltin,  PCBs,  dioxins,  dichlorodiphenyltrichloroethane  (DDT),  have  also  been 
achieved following EU policy.  

64 CuBA Study p. 373 
65 Ibidem p. 78 
66 Ibidem p. 75 
67 Ibidem p. 89 

34 

 
 
 
                                                 
 
 
 
 
 
Figure 8 Mercury, Cadmium and Lead emissions (indexed, 1990-2011) alongside selected regulatory action68 

There are, however, a number of on-going exposure situations that give cause for concern and 
which  point  to  some  shortcomings  in  meeting  the  objectives  of  protecting  human  health. 
These reflect both new, emerging issues, as well as existing ones that require further attention 
in terms of exposure reduction and control. Based on the current evidence69, some of the more 
notable  on-going  exposure  issues  in  the  EU  are  exposures  (see  also  Annex  5  Section  5.1.1. 
B)) to:  

  carcinogenic  substances  at  the  workplace  for  which  occupational  exposure  limits 

(OELs) have not yet been set70;  

  neurotoxic substances;  
  chemicals linked to cardiovascular and respiratory (CVR) disease; and  
  endocrine disrupting chemicals.  

On-going  environmental  exposure  situations  also  give  cause  for  concern,  the  most  notable 
being:  

  Hazardous  chemical  exposures  affecting  the  quality  of  surface  and  ground  waters, 
including  marine  waters,  with  implications  for  their  ecosystems  (and  indirectly  for 
human  health  via  seafood  and  drinking  water  consumption),  despite  considerable 
progress  made  in  reducing  the  discharge  of  pollutants  such  as  nutrients,  pesticides, 
industrial  chemicals,  and  household  chemicals  into  Europe's  waters  over  recent 
decades.  Concern  has  grown  regarding,  for  example,  the  widespread  occurrence  of 
persistent  harmful  substances  such  as  polybrominated  diphenyl  ethers,  which  pose  a 

68 CuBA Study p. 101 Table 6.8 
69 Ibidem, Part A: Protecting Human Health    
70 The European Agency for Safety and Health at Work (EU-OSHA) estimated in 2017 that cancer is the main 
cause of work-related deaths with 106,307 fatal cases per year in the EU-28 (source: EU OSH (2017): What are 
the  main  work-related 
in  DALY: 
injuries 
https://visualisation.osha.europa.eu/osh-costs). Many cases of occupation cancers are due to past exposures. It is 
estimated in the recent proposal to introduce EU-wide OELs for beryllium, cadmium, arsenic, formaldehyde and 
MOCA  (COM(2018)  171  final)  that  when  adopted,  in  the  longer  term  it  would  prevent  over  22  000  cases  of 
work-related ill-health (cancers and non-cancers) 

resulting 

illnesses 

death 

and 

and 

in 

35 

 
 
 
                                                 
risk  even  at  very  low  concentrations.  New  (stricter)  environmental  quality  standards 
have been set for these substances and for some others such as fluoranthene, and these  
are  due  to  be  met  by  2021.  The  results  from  some  Member  States,  e.g.  Sweden, 
Luxembourg  and  the  Netherlands,  indicates  the  new  standard  will  be  difficult  to 
achieve.71  Concern  is  also  growing  that  the  toxicity  of  mixtures  of  chemicals  is  not 
sufficiently  addressed  by  the  legislation,  which  focuses  largely  on  individual 
substances (or small groups).72 

  Hazardous  chemical  exposures  affecting  terrestrial  eco-system  health/resilience  such 

as neonicotinoid pesticides representing a risk to wild bees and honeybees73. 

Respondents  to  the  public  consultation74  from  industry  and  companies  as  well  as  those 
representing  public  authorities  were  overall  the  most  positive  about  the  extent  to  which  the 
EU legislative framework sufficiently addresses emerging areas of concern while civil society 
representatives and citizens assigned the lowest scores.  

3) 

Human health and environmental impact evidence and indicators   

The  trends  in  the  main  health  and  environmental  impact  parameters  that  are  known,  or 
strongly suspected, to be associated with exposures to hazardous chemicals (e.g. trends in the 
incidence rates of certain cancers, reproductive diseases, sperm count and quality and trends 
in  animal  populations  and  eco-system  health/resilience)  are  important  to  consider  when 
examining  the  effectiveness  of  EU  chemicals  policy.  However,  using  human  health  and 
environmental  adverse  effects  as  direct  and  reliable  indicators  of  chemicals  policy 
performance needs to be treated with caution because of the attribution challenge: many of the 
observed  health  and  environmental  adverse  effects  may  derive  from  multiple  causes  (life-
style,  genetics,  habitat  destruction/degradation,  etc.)  and  it  is  difficult  to  determine  to  what 
extent  exposure  to  hazardous  chemicals  contributes  to  the  observed  adverse  effects. 
Complicating things further is the fact that observable adverse effects in human health and the 
environment  often  do  not  materialise  immediately  after  exposure.  For  example,  the  latency 
between exposure to carcinogens and the development of cancer can often be as much as 20 
years or more.  

The  available  evidence  regarding  the  trends  in  the  main  health  and  environmental  impact 
parameters  points  to  a  mixed  picture.  Some  clear  improvements  have  been  achieved,  for 
example,  in  the reduction  of  cancers  related  to  workplace exposure to  a  number  of  targeted 
carcinogens which has resulted in the estimated prevention of 1 million new cancer cases in 
the EU over the last 20 years partly through the implementation of the occupational safety and 
health (OSH) legislation75. However, a number of other trends suggest there is still cause for 
concern, for example: 

71 EEA Report 'European Waters- Assessment of status and pressures 2018 (July 2018) p. 47 
72 Ibidem 
73 such as clothianidin, imidacloprid and thiamethoxam. It was recently confirmed by EFSA that most uses of 
(Source: 
neonicotinoid 
https://www.efsa.europa.eu/en/press/news/180228) 
74 1st FC Study, Annex V, p. 151; public consultation Question 24  
75 Carcinogens and Mutagens at Work Directive (2004/37/EC) 

to  wild 

honeybees 

pesticides 

represent 

bees 

risk 

and 

a 

36 

 
 
                                                 
  The health burdens resulting from most cancers continue to rise in the EU (except for 
lung  cancer)  (see  Figure  9  for  trends  for  breast  cancer).  For  many  cancers,  the 
contributing role of chemical exposures is not yet well understood and defined while 
at the same time suspected to play a role. As a result, it is often unclear which specific 
chemical  exposures  should  be  targeted  by  legislation,  in  an  attempt  to  eliminate 
preventable disease causes. 

Figure 9 Age-standardised incidence rate trends for breast cancer in several European countries 

  The same is true for neurodevelopment and reproductive health. While both male and 
female fertility rates are decreasing in Europe76 77 and while some neurodevelopmental 
disorders  (e.g.  autism)  increase78,  there  is  no  data  on  how  many  of  these  cases  are 
attributable to exposure to hazardous chemicals. However, it is likely that hazardous 
chemicals  play  a  role  in  these  adverse  health  outcomes.79  Substance  categories  of 
concern include  certain phthalates, dioxins, perfluorinated chemicals, analgesics, etc. 

76 Temporal trends in sperm count: a systematic review and meta-regression analysis, Hagai Levine et al, Human 
Reproduction Update, p. 1-14, 2017 
77  Male  reproductive  disorders  and  fertility  trends:  influences  of  environment  and  genetic  susceptibility 
Skakkebaek NE, Rajpert-De Meyts E, Buck Louis GM, Toppari J, Andersson AM, Eisenberg ML, Jensen TK, 
Jorgensen N, Swan SH, Sapra KJ et al. Physiol Rev 2016; 96:55–97 
78 CuBA Study, p. 60 
79 CuBA Study p. 329  

37 

 
 
 
 
                                                 
These issues are more generally linked to the need to obtain better information about 
the spectrum of chemicals with relevance to human exposures and diseases. Achieving 
this  include  improvments  regarding  data  requirements,  toxicological  testing  and 
screening methods human biomonitoring, as well as better predictive and prioritisation 
approaches. 

In the area of the environment, the observed trends also point to a mixed picture:  

 

Improvements in water quality80 in some areas may have contributed to some recovery 
of  aquatic  ecosystems81  and  the  restriction  on  the  use  of  tributyltin  (TBT)  as  an 
antifoulant  in  marine  paints  has  resulted  in  the  recovery  of  mollusc  populations  in 
many ports and coastal areas in Europe82.  

  Major declines (as high as 50-75%) in the populations of a number of animal species 
in  the  EU  have  been  observed  over  the  past  3-4  decades  including  pollinators,  other 
flying insects83 (see Figure 10), amphibians, and birds. Europe’s wild bee population 
is  in  decline  with  nearly  one  in  ten  species  facing  the  threat  of  extinction  and  more 
than  a  quarter  of  bumblebee  species  being  currently  at  risk  of  dying  out84.  The 
populations of over 20% of bird species in the EU are in significant decline85 86, with 
the  largest  declines  (46%  between  1990  and  2014)  for  common  farmland  birds.  The 
causes  of  these  declines  requires  further  research  but  are  likely  to  be  multiple 
including  exposure  to  hazardous  chemicals,  changes  in  agricultural  practices,  habitat 
degradation, climate change, etc.  

80 CuBA Study, p. 185 
81 https://www.eea.europa.eu/publications/state-of-water, p. 32 
82 CuBA Study, p. 204 
83 CuBA Study, p. 387 
84 CuBA Study, p. 387 
85  Inger,  R., Gregory,  R., Duffy,  J.  P.,  et  al. (2014).  Common  European  birds  are declining  rapidly  while  less 
abundant species’ numbers are rising Ecology Letters, DOI:10.1111/ele.12387 
86 The State of Nature in the EU, Reporting under the EU Habitats and Birds Directives 2007–2012 European 
Union, 2015    

38 

 
 
                                                 
Figure 10 Temporal distribution of insect biomass at selected locations in Germany. Daily biomass across 26 locations 
in multiple years  

The  current  approach  and  indicators  used  in  monitoring  and  assessing  human  health  and 
environmental  impacts  could  benefit  from  being  more  holistic.  For  instance,  such  more 
holistic  impact  assessments  could  feed  into  exposure  indicators  (e.g.  passive  sampling, 
representative  mixtures,  human  biomonitoring)  as  well  as 
indicators  (e.g. 
(eco)epidemiology, effect based methods as proposed in the Water Framework Directive).     

impact 

5.1.2  The  objective  of  ensuring  the  efficient  functioning  of  the  internal  market 

and of enhancing competitiveness and innovation   

A. 

What's the issue? 

The EU chemicals legislation aims to ensure the efficient functioning of the internal market 
and  to  enhance  competitiveness  and  innovation.  The  effectiveness  of  the  EU  chemicals 
legislation in achieving these objectives can therefore be measured by analysing: 

 
 
 

trends in the development of intra-EU sales of chemicals compared to domestic sales; 
trends in the EU export of chemicals and global market share; 
the role that the legislation plays in boosting the competitiveness of the EU chemicals 
industry and innovation.  

B. 

What are the findings? 

Conclusions 

EU chemicals legislation has been instrumental in ensuring the free circulation of chemicals 
and products within the internal market through the harmonisation of requirements, standards, 
risk  management  measures,  labelling,  and  mutual  recognition  approach  that  reduce  barriers 
for intra-EU trade. 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,  this  being  reflected  in  the  growth  in  intra  EU  trade.  The  EU  remains  the  largest 
chemicals  exporting  region  in  the  world  and,  despite  the  decline  of  the  share  (although 
absolute sales levels have increased) in the global market the EU chemicals industry remains 

39 

 
 
 
internationally  competitive.  However,  some  interpretation,  implementation  and  enforcement 
issues at Member States level leave room for further improvements.  

While the EU chemicals industry is often seen as a frontrunner in terms of innovation, there is 
no evidence that the EU chemicals legislation, as such, is either a major trigger of, or barrier 
to, innovation for companies in general.  

EU  chemicals  legislation  has  been  instrumental  in  ensuring  free  circulation  of  substances, 
mixtures  and  articles  within  the  internal  market  through  harmonisation  of  standards  and 
requirements that reduced barriers for intra-EU trade. There has been a continuous increase of 
the share of the intra-EU trade of chemicals i.e. EU companies selling in the EU single market 
rather than in their home country market, in the total sold production of chemicals (from 43% 
in  2006  to  55%  in  2016)87.  For  example,  the  CLP  Regulation  provides  the  basis  for 
consistently  identifying  properties  of  concern,  with  this  information  then  used  in  hazard 
communication  to  workers,  downstream  users  and  consumers  of  chemicals.  Similar  trends 
have been observed in the fields of cosmetics, detergents, fertilisers, etc., where EU product 
specific legislation has been adopted. The fact that many Directives have become Regulations 
contributed to harmonisation across the EU and therefore a better functioning internal market. 
Nevertheless,  there  are  still  areas  where  divergences  in  interpretation,  implementation  and 
enforcement continue to persist potentially leading to fragmentation  of the European market 
and creating burden and barriers for businesses (see Annex 5 Section 5.1.2). 

In  terms  of  international  competitiveness,  the  EU  chemical  industry  in  2016  represented 
15.1% of the global market, behind China (39.6%) but ahead of the United States (14.2%)88. 
Although the European share of global sales has decreased (32.5% in 1996) the EU chemicals 
industry remains internationally  competitive as evidenced by the trade surplus  of  EUR 47.2 
billion (exports  EUR  146.2  billion,  imports  EUR  99  billion)89.  The  decrease  in  the  share  of 
global sales is  mainly  due to  relative growth  in other  parts of the world, such  as  China and 
India, served by their own domestic production. Other potential reasons given for this are high 
energy prices, currency appreciation, high labour costs, regulatory and tax burdens.90 Yet the 
EU  remains  the  largest  chemicals  exporting  region  in  the  world91.  The  main  competitive 
advantage of the EU chemical industry is the high level of technological development, skilled 
workforce and strong research base.  

As an input provider for other industries, the chemicals industry is also considered to be at the 
forefront  of  innovation  and  a  solution  provider  for  many  societal  and  environmental 
challenges,  with  chemical  technological  breakthroughs  spilling  over  into  downstream 
sectors92.  As  mentioned  above,  the  beginnings  of  a  possible  positive  trend  can  be  observed 

87 The intra-EU sales 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, CEFIC, 2017 
88 Ibidem 
89 Ibidem 
90 Ibidem 
91 CEFIC Facts and Figures Report, CEFIC, 2017, p. 21 
92  CEFIC  (2015):  Competitiveness  of  the  European  Chemicals  Industry:  How  to  regain  ground  in  the  global 
market.  Available  at:  http://www.cefic.org/Documents/RESOURCES/Reports-and-Brochure/Competitiveness-
of-the-European-chemical-industry-2014.pdf quoted in the 1st FC Study Annex IV p. 54 

40 

 
 
                                                 
concerning  substitution  to  less  hazardous  or  non-hazardous  substances93  for  substances 
hazardous to the environment. In many cases, hazard classification under the CLP alone for 
example is an incentive for substitution as it triggers a number of legal obligations, including 
labelling  and  communication  to  downstream  users  as  well  as  consumers.  Indeed,  increasing 
consumer  awareness  of  the  health  risks  associated  with  certain  hazard  classifications  (most 
notably carcinogens) is a powerful trigger for substitution in the supply chain.94 In other cases, 
risk  management  measures  (such  as  bans  and  restrictions)  triggered  by  a  certain  hazard 
classification provide such incentives95. Innovation and substitution are encouraged by many 
pieces of legislation acting in concert and supported by drivers, such as consumer demands, 
market  circumstances  and 
the  Substitution  Support  Portal 
(SUBSPORT) under the European Union’s Life programme96. Overall impacts of chemicals 
legislation  on  innovation  are,  however,  more  complex,  as  described  in  the  REACH 
Evaluation97. As no specific indicators exist for assessing these and also given that many other 
factors play a role e.g. intention to develop new applications in order to conquer new markets, 
it  is  currently  not  possible  to  know  whether  the  EU  chemicals  legislation  has  been  a  major 
trigger of innovation. 

initiatives  such  as  e.g. 

The EU chemicals legislation was considered by citizens, industry and companies and public 
authorities  as  mostly  effective  in  ensuring  a  well-functioning  internal  market  while  civil 
society  considered  it  to  be  moderately  effective.98  Regarding  this  particular  aspect,  SME 
Panel  results  showed  that  the  EU  chemicals  legislation  is  considered  to  be  sufficiently 
harmonised across Member States for the proper functioning of the European single market. 
While citizens, industry and companies and civil society considered the legislation moderately 
effective in stimulating competitiveness and innovation, public authorities were of an opinion 
that it is mostly effective in reaching this objective.99  

5.2  Evaluation  question:  what 

factors  affect  (either  positively  or 
negatively) the correct functioning of the EU legislative framework for 
the hazard identification and risk management of chemicals? What are 
the consequences or effects that were not originally planned for? 

An effective framework of chemicals legislation ensures the timely and sound identification 
of chemical hazards and risks, the appropriate control of human and environmental exposures 
to hazardous chemicals and, for hazardous chemicals where the exposures cannot be reliably 
controlled,  a  progressive  shift  towards  the  use  of  less  hazardous  chemicals  (substitution) 
including non-chemical solutions.  

The basic steps of the risk management procedures and processes applied to chemicals within 
the  EU  framework  of  chemicals  legislation (see  Section  2.1  and  Annex  8  for  further  detail) 
are:  

93 1st FC Study Annex IV p. 55 
94 1st FC Study, Annex IV, p. 56 
95 Ibidem 
96 https://www.subsport.eu/ 
97 REACH Evaluation SWD, chapter 6.1.1.3.3, p. 51 ff. 
98 1st FC Study, Annex V, p. 32-38; public consultation Question 10 
99 Ibidem  

41 

 
 
                                                 
  hazard identification (based on toxicity tests and other relevant information); 
  dose (concentration) – response (effect) assessment; 
  exposure assessment – exposure scenarios for relevant uses of the chemical (based on 

models and measurements of the occurrence of the chemical); 
risk characterisation; and 
risk estimation. 

 
 

The  correct  functioning  of  each  of  these  risk  management  steps  can  be  affected  by  one  or 
more key performance factors, including: 

  Whether  the  necessary  scientific  knowledge  (including  recognised  and  accepted  test 
methodologies  for  hazard  identification)  and  data/information  (e.g.  on  chemical  uses 
and  exposure  scenarios)  are  available,  are  used  appropriately  and  can  be  shared 
between different risk assessment regimes to ensure the coherence of findings and to 
avoid duplication of effort. 

  Whether and how the hazard identification and risk assessment process is triggered. 
  Whether  the  overall  'speed'  of  the  hazard  identification  and  classification  and  risk 
assessment  processes  can  handle  the  quantity  of  existing  and  newly  designed 
hazardous chemicals placed on the market. This is not simply a question of efficiency 
but, fundamentally, of effectiveness. If the framework fails to identify and address the 
hazards and risks  of chemicals in  a timely manner, its effectiveness is reduced.  This 
also requires further discussion on how to better prioritise and in which areas and/or 
for which substances such prioritisation would be necessary.  

  Whether  the  necessary  competences  and  resources  are  available  at  EU  and  Member 
State level to ensure robust and timely hazard identification/assessment/classification, 
risk assessment and risk management decision-making. 

  Whether  the  use  of  generic  risk  considerations  (GRC)  and  specific  risk  assessment 

(SRA) based approaches is appropriate and balanced. 

  Whether  the  desired  transition  to  non-animal  test  methods  is  happening  and  is 

effective. 

These  different  factors  can  affect  the  performance  of  one  or  more  of  the  risk  management 
steps outlined above. For example, poor quality or missing data affects the ability to correctly 
identify  and  classify  hazards,  to  determine  reliable  exposure  scenarios,  and,  therefore,  to 
arrive  at  a  robust  risk  assessment.  The  assessment  of  the  effectiveness  of  the  framework  of 
EU  chemicals  legislation  has,  therefore,  been  structured  and  presented  according  to  these 
factors.  

5.2.1  Data, knowledge and information  

A. 

What's the issue? 

Scientific  understanding  and  the  availability  of  good-quality,  reliable  data  underpins  the 
effective functioning of EU chemicals legislation. It includes, among other things, knowledge 
and  information  on  chemical  properties,  data  on  eco-toxicity  of  chemicals  and  on  chemical 
uses  and  exposures  to  chemicals  (including  occurrence  in,  and  release  from,  articles 
(consumer products)).  

Please refer to Annex 5 Section 5.2.1 for a more detailed description of data, knowledge and 
information related aspects. 

42 

 
 
B. 

What are the findings? 

Conclusions 

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.  Much  of  this  effort  has  been  resourced  and  underpinned  by  industry  assuming  the 
responsibility  of  ensuring  the  safe  use  of  chemicals  placed  on  the  market.  This  has  been 
helped  by  significant  investment  in  EU-level  capacity  for  supporting  the  risk  assessment 
processes  under  the  various  chemicals  legislation  regimes  (ECHA,  EFSA,  and  a  number  of 
scientific committees).  

While  the  existing  test  guidelines  cover  the  majority  of  known  adverse  effects  on  human 
health  and  the  environment,  they  can  be  further  improved.  Standardised  and  internationally 
recognized  test  guidelines  still  need  to  be  developed  and/or  validated.  This  is  the  case  for 
certain environmental adverse effects such as the terrestrial compartments and some specific 
terrestrial species. This is also the case for neurotoxicity, immunotoxicity and some endocrine 
disruptors related aspects.   

The EU has put considerable efforts and resources in promoting the avoidance or reduced use 
of  animal  testing.  However,  there  are  still  barriers  to  the  use  and  acceptance  of  alternative 
(non-animal) test methods for regulatory purposes, partially linked to lack of test guidelines 
for certain effects or to gaps in the current knowledge.  

The  current  state  of  knowledge  regarding  exposure  scenarios  i.e.  knowledge  of  which 
chemicals and their combinations, and at what concentrations, humans  and the environment 
are being exposed to, needs further attention.  

The  scientific  understanding  of  mechanisms  and  pathways  of  how  hazardous  chemicals 
interact  with  organisms  has  improved  considerably  over  the  last  two  decades  with,  for 
example, the support of the Commission's research framework programmes.  

Much has also been done to improve the quality, reliability and reproducibility of hazard and 
risk  assessment  studies  and  data.  Quality  standards  are  prescribed  for  how  hazard  and  risk 
analysis  is  to  be  conducted,  including  the  testing  methodologies.  Toxicity  studies  submitted 
by chemicals producers or importers need to be performed according to validated test methods 
and guidelines. In addition, the laboratories that perform chemical hazard and risk assessment 
studies must comply with the GLP requirements100. During the workshops, there was general 
agreement  amongst  participants  that  the  GLP  requirements  help  to  ensure  that  the  rigorous 
documentation about how a study was conducted is made available. This is, good to have as it 
allows comparability and reproducibility but they are not sufficient to ensure high scientific 
quality.101  

Validated test methods and guidelines help to ensure comparability and reproducibility of data 
produced and thus increase the reliability and quality of data. International agreement on test 

100 http://ec.europa.eu/growth/sectors/chemicals/good-laboratory-practice_en 
101 See 1st FC Study Workshop report p. 15-18. See also FC+ Study p. 43 and onwards 

43 

 
 
                                                 
guidelines  (under  OECD)  ensures  the  mutual  acceptance  of  the  data  among  countries  and 
regions, which lowers the technical barriers to trade and reduces also the number of animals 
used for testing. The existing test guidelines cover the majority of known adverse effects on 
human  health  and  the  environment.  However,  standardised  test  methods  and  guidelines  are 
lacking  for  certain  environmental  adverse  effects  (soil  biota,  reptiles,  and  other  terrestrial 
animal  species).102  There  is  also  a  need  to  further  improve  the  existing  test  methods  and 
guidelines regarding neurotoxicity, immunotoxicity, epigenetics, endocrine disruption as well 
as how to capture peculiarities of nanomaterials.103   
The  policy  on  the  protection  of  animals  used  for  scientific  purposes104  has  streamlined 
resources and efforts towards the development of alternative methods to replace, reduce, and 
refine  animal  testing.105  To  date,  this  focus  has  been  successful  for  five  human  health 
endpoints106, for which tests have been validated and recognised internationally107. However, 
there are still barriers to the use and acceptance of alternative test methods, and no methods 
are  available  yet  to  fully  evaluate  complex  systemic  endpoints.108  The  identified  gaps  in 
existing test guidelines for endpoints relevant for human health and the environment call for 
development of new test methods and adequate funding is required for both approaches, non-
animal  and  animal.  In  addition,  there  is  a  need  to  accelerate  the  regulatory  acceptance  of 
alternative test methods109 (see also Annex 5 Section 5.2.2).  

The  EU  chemicals  legislation  requires  in  principle  the  use  of  'all  available  information'.  A 
number of stakeholders, however, expressed concern that potentially relevant and useful peer-
reviewed  scientific  studies  and  data  were  being  ignored  or  overlooked  during  regulatory 
hazard  and  risk  assessments  because  they  are  not  GLP-compliant110.  This  warrants  some 
attention and action because the peer-reviewed studies may use test designs, test species and 
test endpoints that are more sensitive and relevant than those used in standardised studies and 
can, therefore, be an important complement to the standardised studies provided that they are 
reliable  and  properly  documented.  Moreover, lack  of  awareness  of  authorities  regarding  the 
availability of relevant or new information and data for hazard and risk assessment contributes 
to a situation where it can take several years111 between the first concerns and evidence being 

102 CuBA study p. 368. Regarding in particular endocrine disruptors see COM(2018) 734 final p. 3-4 
103 Epigenetics literally means "above" or "on top of" genetics. It refers to external modifications to DNA that 
turn  genes  "on"  or  "off."  These  modifications  do  not  change  the  DNA  sequence,  but  instead,  they  affect  how 
cells "read" genes. Epigenetic changes alter the physical structure of DNA. Epigenetic changes can be heritable 
to the next cell generations (mitotic) but also to the next generation of an organism (meiotic). 
104  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  
105 REACH Evaluation SWD(2018) 58 final, Annex IV 
106 Skin corrosion/irritation, serious eye damage/eye irritation and skin sensitisation 
107 Some testing strategies have been developed, also leading to an overall reduction of the use of animals. See 
for  example  the  European  Union  Reference  Laboratory  for  Alternatives  to  Animal  Testing  (EURL  ECVAM) 
Strategy to replace, reduce and refine the use of fish in aquatic toxicity and bioaccumulation testing available at 
https://ec.europa.eu/jrc/en/publication/eur-scientific-and-technical-research-reports/eurl-ecvam-strategy-replace-
reduce-and-refine-use-fish-aquatic-toxicity-and-bioaccumulation   
108 Regulatory fitness check of CLP and related legislation - Case study 4, p. 9-12 
109 Regulatory fitness check of CLP and related legislation - Case study 4, p. 19-20 
110 FC+ Study p. 45 and onwards 
111 Polychlorinated Biphenyls (PCBs) are among a group of man-made chemicals that are known as Persistent 
Organic Pollutants (POPs). PCBs were commercially produced world-wide on a large scale between the 1930s 

44 

 
 
                                                 
 
published  in  the  academic  journals  and  the  regulatory  hazard  and  risk  assessments  being 
triggered. Tools are currently lacking to ensure continuous monitoring of scientific papers and 
publications and mechanism for the identification of, and reaction to, early warning signals. 

As regards exposure data in particular, there continue to be significant gaps in our knowledge 
of  which  chemicals  and  their  combinations,  and  at  what  concentrations,  humans  and  the 
environment  are  being  exposed  to.  These  gaps  have  an  impact  on  determining  realistic, 
acceptable  and  robust  exposure  scenarios.  The  main  difficulties  can  be  summarised  as 
follows: 

  Exposure assessments typically make use of a combination of models, laboratory data 
and monitoring to calculate the potential exposure within a given scenario. In order to 
successfully conduct exposure assessments, the models in use have to be underpinned 
by  data,  and  likewise  real  world  analysis  is  needed  to  validate  results.  Additional 
monitoring  to  validate  models  is  often  a  step  that  is  overlooked  in  the  EU  risk 
assessment processes and this undermines the quality of the results.112 

  Exposure  scenarios  used  in  setting  ‘safe’  exposure  limits,  are  established  based  on 
intended, normal, reasonable and/or foreseeable use of a product (e.g. cosmetic, plant 
protection,  biocidal,  detergent  products)  or  foreseeable/predictable  situation  (e.g. 
occupational  or  industrial  settings).  There  is  evidence  that  for  hazardous  chemicals 
with  a  broad  range  of  applications  in  a  myriad  of  different  consumer  products, 
industry and public authorities may be unaware of many uses.113 In addition, there are 
no requirements on producers of hazardous chemicals for example to make available 
substance-specific  information  on  actual  amounts  marketed.  As  an  initial  step,  the 
Commission  recently  began  to  tackle  this  issue  for  veterinary  antibiotics  where 
reporting obligations on volumes used have been introduced.114 

  Yet,  even  when  all  uses  and  amounts  are  known,  determining  realistic  exposure 
scenarios  can  still  be  problematic  where  consumer  behaviour  is  difficult  to  predict. 
Determining  and  characterising  exposure  in  an  occupational  setting  by  way  of 
comparison  is  relatively  more  straightforward,  as  the  exposure  scenario  is  more 
controlled and predictable.115 

To  address  the  issue  of  human  health  exposure  data,  the  EU  Commission  has  funded  the 
European  Human  Biomonitoring  Initiative  (HBM4EU).116  However,  a  similar  holistic 

and 1980s. In the 1970s, owing to severe concerns pertaining to their human toxicity, suspected carcinogenicity, 
and environmental persistence, several countries limited the use of PCBs. Finally in 1985, the use and marketing 
of PCBs in the European Community were very heavily restricted. Measures regarding the disposal of PCBs and 
PCTs  and  equipment  containing  PCBs  were  taken  in  1996.  In  2001,  the  Commission  adopted  a  Community 
Strategy on Dioxins, Furans and PCBs aimed at reducing as far as possible the release of these substances in the 
environment and their introduction in the food chains. 
112 FC+ Study p. 51 
113 Market survey on articles treated with biocides, KEMI PM 6/16 
114 
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000302.jp  . 
It should be however noted that medicinal products legislation is not in the scope of this Fitness Check. 
115 FC+ Study p. 68 
116 
amounts 
EU 
The 
https://cordis.europa.eu/project/rcn/207219_en.html 

contribution 

million. 

around 

EUR 

See 

50 

to 

45 

 
 
                                                                                                                                                         
initiative  for  animals,  plants  and  eco-systems  is  currently  lacking117  118.  The  screening  of 
'unknowns' (i.e. sampling and testing designed to detect unsuspected hazardous chemicals) in 
humans and the environment is also missing. 

5.2.2  Hazard and risk (re-)assessment   

A. 

What's the issue? 

The  obligation  to  perform  hazard  and  risk  assessments  or  re-assessment  sits  primarily  with 
industry, in line with the principle of reverse burden of proof119. Public authorities (national or 
EU)  intervene  only  in  a  limited  number  of  cases  (in  areas  of  the  highest  potential  risks  to 
human health and/or the environment).   

Please  refer  to  Annex  5  Section  5.2.3  for  more  detailed  description  of  how  hazard/risk 
assessment is triggered.  

B. 

What are the findings? 

Conclusions 

Where  the  initiative  to  trigger  the  hazard/risk  assessment  sits  with  industry  and  there  is  a 
positive incentive to do the assessment (e.g. seeking authorisation to place a product on the 
market),  the  quality  of  the  risk  assessment  dossiers  tend  to  be  good.  For  the  pieces  of 
legislation where the underpinning mechanism relies on the presumption of conformity with 
the  existing  rules,  information  is  scarce  and  therefore  does  not  allow  to  conclude  on  the 
quality of conformity assessments carried out. It appears however clearly that the capacity and 
resources  of  the  EU  and/or  Member  State  authorities  to  check  the  quality  of  these  self-
assessments are paramount but are often constrained.   

The  obligation  to  perform  risk  assessments  sits  primarily  with  the  industry  in  line  with  the 
principle  of  reverse  burden  of  proof.  Risk  assessment  can  also  be  initiated  by  public 
authorities,  both  at  the  EU  and  MS  level  e.g.  the  Commission  will  trigger  risk  assessment 
under the Water Framework Directive and Industrial Emissions Directive.  

The effectiveness of the obligation for industry to carry out a risk assessment, i.e. whether risk 
assessments are done and to what quality, is influenced by the following aspects: 

  existence of a commercial interest to gain approval/authorization, 

117  However  the  monitoring  of  emerging  pollutants  is  carried  out  since  2011  by  the  Network  of  reference 
laboratories  for  monitoring  emerging  environmental  pollutants  (NORMAN  Association)  together  with  the 
Commission  to  support  the  Common  Implementation  Strategy  of  the  Water  Framework  Directive.  More 
information 
is  available  at  https://ec.europa.eu/jrc/en/publication/norman-interlaboratory-study-ils-passive-
sampling-emerging-pollutants   
118  SOLUTIONS is a  project  funded by  the  EU  aiming  at  searching for  new  and  improved  tools,  models,  and 
methods to support decisions in environmental and water policies. The overall goal of the project is to produce 
consistent  solutions  for  the  large  number  of  legacy,  present  and  future  emerging  chemicals  posing  a  risk  to 
European  water  bodies  with  respect  to  ecosystems  and  human  health.  More  information  available  at 
https://www.solutions-project.eu/project/#article-24  
119 Reverse burden of proof means that industry is responsible for ensuring the safe use of their chemicals and 
therefore  carrying  out  the  risk  assessment  and  ensuring  the  risk  management  of  their  chemicals,  including 
testing. Public authorities are responsible for checking if this obligation is properly implemented and, where not, 
to quickly and efficiently propose measures to manage potential risks appropriately. 

46 

 
 
                                                 
  existence  of  a  prescription  for  how  the  risk  assessment  should  be  performed  and 

documented, and 

  existence  of  an  obligation  to  communicate  the  outcome  of  the  assessment  to  public 

authorities and/or downstream users. 

are 

legally 

required  only 

Systematic  checks  by  EU  and/or  national  public  authorities  of  the  risk  assessment  done  by 
industry 
legislation  where 
for 
authorisation/approval/permit  is  needed  before  the  substance/product  can  be  placed  on  the 
market (e.g. plant protection products, biocidal products) or activity can be carried out (e.g. 
industrial  activities,  including  waste  management  activities).  In  such  cases,  the  quality  of 
dossiers  submitted  by  industry  and  the  robustness  of  the  overall  assessment  are  generally 
good.120 

certain  pieces  of 

Under  other  product  related  legislation  (e.g.  the  Cosmetic  Products  Regulation,  the  RoHS 
Directive,  the  Toy  Safety  Directive,  the  Detergents  Regulation)  and  the  occupational  safety 
and  health  (OSH)  legislation,  the  underpinning  mechanism  is  based  on  conformity/safety 
assessment done by economic operators themselves and the presumption of conformity with 
the existing rules.121 In these cases, assessments carried out are not systematically checked by 
public authorities. Therefore, ensuring that only safe products are placed on the market or that 
worker  safety  rules  are  complied  with,  relies  primarily  on  economic  operators,  including 
importers,  who  can  be  held  responsible  for  non  compliance.  This  approach  reduces  the 
administrative burden for public authorities. However, ensuring that this obligation is actually 
complied with still relies on Member States and depends in particular on market surveillance 
activities and inspections carried out at national level which requires considerable resources. 
The recent ECHA report has shown that the compliance with the general safety obligation is 
challenging122  but  more  evidence  and  information,  including  data  from  regular  market 
surveillance  or  other  similar  or  equal  mechanisms,  need  to  be  gathered  to  conclude  on  the 
level of compliance of self-assessments (and thus on the level of enforcement).  

The  EU  chemicals  legislation  requires  risk  assessments  to  be  updated.  However,  there  are 
some  differences  in  the  level  of  stringency  of  the  legal  provisions.  In  some  cases,  the 
legislation will  specify  the  frequency  or  conditions  that  will trigger  a re-assessment  e.g.  the 
Biocidal  Products  Regulation,  the  Plant  Protection  Products  Regulation,  the  Ecolabel 
Regulation, the Industrial Emissions Directive and the Water Framework Directive. In  most 
cases  however  re-assessment  is  required  if  and  when  new  scientific  knowledge  and/or 
evidence emerge.123  All  the  factors  identified  above  for  the initial  assessment  are  also  valid 
for  re-assessments.  Re-assessments  seem  to  be  more  effective  when  there  is  an  automatic 
trigger  in  the  legislation  such  as  expiration  of  the  approval  of  active  substances  for  plant 
protection products (usually 10-15 years). More evidence needs to be gathered to conclude on 
the effectiveness of re-assessments in cases where they are to be triggered by new scientific 
knowledge.   

120 FC+ Study p. 58-66 
121 In this case, the economic operator declares on his sole responsibility that the products concerned satisfy the 
requirements of the legislative instrument that apply to them. 
122 https://echa.europa.eu/-/inspectors-find-phthalates-in-toys-and-asbestos-in-second-hand-products 
123 FC+ study p. 64 

47 

 
 
                                                 
Respondents  to  the  public  consultation  were  asked  to  indicate  their  satisfaction  with  risk 
assessment  and  characterisation124  which  received  the  lowest  weighted  score  from  Citizens 
and  NGOs  and  others  but  was  scored  relatively  highly  by  industry  associations  and  public 
authorities. 

5.2.3  Hazard classification  

A. 

What's the issue? 

The communication of chemical hazard  properties to  downstream users is  an  important risk 
management measure that helps ensure the safe handling of chemicals and mixtures. It needs 
to  be  underpinned  by  reliable,  robust  hazard  classification.  Hazard  classification  is  also 
crucial  for  other  risk  management  processes  within  the  framework  of  EU  chemicals 
legislation, such as restrictions or authorisations.  

Please  refer  to  Annex  5  Section  5.2.4  for  more  detailed  description  of  how  hazards  are 
classified under the EU chemicals legislation. 

B. 

What are the findings? 

Conclusions 

As  the  primary  basis  for  most  chemical  hazard  assessment  and classification in  the  EU,  the 
CLP  Regulation  is  effective  and  is  considered  by  the  majority  of  stakeholders  as  an 
improvement  over  the  earlier  Directives  that  it  replaced.  Some  issues,  however,  were 
identified with respect to the pace and focus of harmonised classifications, the classification 
of mixtures, and inconsistencies in industry self-classifications. 

Two processes are available for classification: 

  For  hazards  of  highest  concern  (carcinogenicity,  mutagenicity,  reproductive  toxicity 
(CMR)  and  respiratory  sensitisers)  and  for  other  substances  on  a  case-by-case  basis, 
classification  and  labelling  should  be  harmonised  throughout  the  EU  to  ensure  an 
adequate  risk  management.  This  is  done  through  harmonised  classification  and 
labelling  (CLH).  Harmonised  classifications  are  listed  in  Annex  VI  to  the  CLP 
Regulation.  

  Under  the  CLP,  a  substance  must  be  self-classified  by  manufacturers,  importers  or 
downstream users when it has  no harmonised classification in Annex VI to the CLP 
and it presents hazardous properties. This classification and labelling information for 
the  substances  to  be  placed  on  the  market  is  then  notified  by  manufacturers  and 
importers  to  the  Classification  and  Labelling  Inventory  (CLI)  held  by  ECHA. 
Mixtures must always be self-classified before being placed on the market, as they are 
not subject to CLH.  

The  harmonised  classification  is  an  important  instrument  for  achieving  the  safe  use  and 
enhancing the substitution of hazardous chemicals. It is also linked with the approval process 
for plant protection product and biocidal product active substances. 

124 1st FC Study, Annex V p. 122; public consultation Question 17 

48 

 
 
                                                 
According to ECHA the number of assessments for harmonised classifications under the CLP 
Regulation  is  relatively  low  compared  to  the  likely  number  of  chemicals  which  merit  a 
harmonised  classification.125  During  the  public  consultation,  citizens  and  civil  society 
organisation  considered  the  speed  of  the  procedures  for  CLH  slightly  satisfactory,  industry 
considered it to be moderately satisfactory and public authorities considered the speed to be 
mostly  satisfactory.126  The  main  consequence  of  this  ‘slow’  pace  is  that  not  all  of  the 
potentially hazardous chemicals which would therefore merit a harmonised classification are 
dealt with thus potentially prolonging exposure of EU citizens to such hazardous chemicals.  

It seems to be due to the following capacity constraints:  

  Currently, the main focus is on active substances used in plant protection and biocidal 
products.  This  explains  the  fact  that  relatively  few  harmonised  classifications  are 
being done for industrial chemicals.  

  Much  of  the  current  situation  is  a  reflection  of  the  high  resource  needs  (staff/expert 
capacity) at Member State level for preparing a classification dossier, combined with 
reductions in resources and budgets allocated for this work in many Member States, in 
particular  following  the  2008  financial  crisis.  There  is  also  considerable  variation 
between  Member  States  in  their  capacity  and  willingness  to  initiate  harmonised 
classification  dossiers  with  just  a  few  Member  States  carrying  the  majority  of  the 
burden.127  

  The  current  speed  also  reflects  the  need  to  ensure  that  all  the  relevant  opinions, 

 

including stakeholder views are taken into account.  
In many cases, the process is slowed down and there is some reticence because of the 
consequences that the harmonised classification may trigger in downstream legislation 
e.g. ban of CMRs under the Cosmetic Products Regulation or cut-off criteria under the 
Plant Protection Products Regulation.128 In this regard, it should be noted that efforts 
have already been made in order to speed up the CLH process. A fast track procedure 
was  introduced  by  ECHA  for  discussing  non‐ controversial  endpoints.  ECHA 
indicated  that  in  the  RAC  meeting  where  this  was  introduced,  65%  of  classification 
proposals for such endpoints went through without discussion.129  

  Currently, there is no quantified objective or a point of reference to compare with to 
evaluate  the  speed  of  the  classification  and  to  know  how  many  substances  and  by 
when  these  need  to  have  a  harmonised  classification.  In  addition,  the  Commission 
lacks  the  legal  basis  for  initiating  the  harmonised  classification  process  or  to  ask 
ECHA  to  develop  dossiers  while  industry  can  initiate  and  submit  harmonised 
classification  dossiers  only  for  a 
limited  number  of  substances.  Regarding 
classification  of  active  substances  for  plant  protection  and  biocidal  products  and 
revision of the existing entries, only Member State Competent Authorities can submit 
proposals,  but,  according  to  industry,  they  are  difficult  to  approach  or  not  always 
cooperative.  

125 ECHA Report on the Operation of REACH and CLP 2016 p. 117 
126 1st FC Study Annex V, p. 204 and onwards, question 34 
127 1st FC Study Annex II, p. 47-48 
128 1st FC Study Workshop report p. 19  
129 1st FC Study Annex II, p. 43 

49 

 
 
                                                 
As regards self-classifications by industry under the CLP Regulation, there are often multiple 
classifications for the same substance submitted to be registered in the CLI because different 
notifiers fail to arrive at an agreed entry despite the legal obligation to make every effort to do 
so.  Furthermore,  there  are  concerns  about  the  reliability  of  some  of  the  self-classifications 
which  is  exacerbated  by  the  lack  of  legal  basis  for  ECHA  to  correct  or  delete  obvious 
mistakes, to remove entries by companies which have ceased to exist or for substances which 
are no longer placed on the market (especially below 1t/y) and to  get  in direct contact with 
notifiers/registrants, in order to initiate a correction or obligation for manufacturer/importer to 
check the quality of the information being notified.130 This affects the value of the CLI as a 
hazard communication tool. The Commission and ECHA are actively looking into a number 
of ways to improve the situation.131  

The  lowering  of  generic  concentration  limits  for  some  hazard  classifications  under  the  CLP 
compared to the levels prescribed under the previous regime (i.e. the Directive which the CLP 
Regulation  replaced),  in  particular  for  skin  and  eye  irritation  or  corrosion,  has  resulted  in 
more  stringent  classifications  when  classifying  mixtures  using  the  ‘calculation  method’. 
Stakeholders  representing  the  detergent  sector  stated  that  it  leads  to  over-classifications. 
Similarly,  because  SMEs  are  more  likely  to  depend  on  the  calculation  methods  to  classify 
mixtures  (due  to  cost  considerations),  they  are  also  more  likely  to  place  more  conservative 
hazard classifications on their products than companies that can do the necessary testing. In 
principle,  the  bridging  principle132  classification  method  could  address  this  issue.  Bridging 
principles are basic principles used to classify un-tested mixtures under the CLP Regulation 
and the UN Global Harmonised System (GHS). However, the lack of clarity with respect to 
how  to  apply  these  principles  hampers  the  effectiveness  of  this  method.133  It  also  leads  to 
discrepancies  in  interpretation  and  acceptance  of  classification  by  Member  States.  The 
Commission is now taking steps to address this issue, including guidance on the harmonised 
application of the legal requirements. 

Issues  with  mixture  classification  have  also  been  raised  by  metal  industry  stakeholders  in 
relation  to  metals  and  metal  alloys  e.g.  the  alloy  used  in  Euro  coins  and  the  stainless  steel-
nickel-cobalt  alloys  used  as  medical  implants.134  While  the  metal  alloys  are  to  be  classified 
following the CLP chemical mixtures classification rules, this stakeholder group believes that 
it  leads  to  metallic  alloys  receiving  classifications  that  do  not  match  their  real  hazard 
properties. They also believe that this situation could have negative consequences on metals 
recycling and thus on the realisation of circular economy with some unintended consequences 
in downstream legislation (e.g. the Toy Safety Directive, the Transport of Dangerous Goods 
Directive,  the  Industrial  Emissions  Directive).  It  should  be  noted  that  the  Commission  has 
already  been  made  aware  of  these  concerns  and  has  started  to  address  them,  in  particular 

130 1st FC Study Annex II p. 130-135 
131 1st FC Study p. 25 
132 ECHA Guidance on the Application of the CLP Criteria Version 5.0 – July 2017, p. 68-72 
133 1st FC Study p. 15-16, p. 41-42; see also Annex II p. 20 and onwards 
134 1st FC Study, Annex II p.27 and onwards. See also 1st FC Study Annex VI Case Study 2. This issue was also 
brought  up  and  discussed  more  recently  by  the  Federation  of  Finnish  Technology  Industries  at  the  REFIT 
Platform.  This  stakeholder  group  called  upon  the  Commission  to  review  the  current  classification  rules  for 
metallic alloys and issue a guidance on the interpretation of article 1.3.4 of the CLP in the context of the circular 
economy,  as  well  as  to  support  the  efforts  of  the  metal  industry  in  developing  a  new  test  method  in  order  to 
improve the classification of metallic alloys to be based on their intrinsic properties. 

50 

 
 
                                                 
through  the  bio-elution  project  135  136  (involving  industry  stakeholders)  which  is  reviewing 
possible test methods for assessing the bioavailability/exposure to metals in alloys. Whether, 
and  how,  several  other  hazard  classes  such  as  persistent,  bioaccumulative  and  toxic/very 
persistent and very bioaccumlative substances (PBTs/vPvBs), endocrine disruptors (EDs), and 
neurotoxicity are addressed by the EU chemicals legislation is further discussed in the Section 
7  Coherence  (for  more  details  on  specific  substances,  i.e.  CMRs,  PBTs/vPvBs,  EDs  please 
refer to Annex 7). 

5.2.4  Communication  of  hazards  and  risks  to  consumers  and  professional  users 

and public authorities  

A. 

What's the issue? 

Communication  of  hazard,  risk  and  safety  information  about  chemical  substances  and 
mixtures to users, consumers, workers and public authorities is a key measure to promote the 
safe  use  of  chemicals,  to  mitigate  risks  and  to  help  users  make  informed  product/substance 
related  choices.  Various  communication  measures  exist  across  the  legislative  framework. 
Their  effectiveness  has  a  direct  impact  on  the  correct  functioning  of  the  EU  chemicals 
framework and on achieving its objectives.  

Please  refer  to  Annex  5  Section  5.2.5  for  more  detailed  description  of  rules  regarding 
communication of hazards and risks and the related aspects. 

B. 

What are the findings? 

Conclusions 

The  requirements  to  communicate  chemical  hazards  and  risks  to  consumers,  workers,  and 
professional users via hazard pictograms, labels and safety data sheets is considered by most 
stakeholders  to  be  generally  effective  and  important.  Some  concerns  have  been  raised  by 
industry stakeholders that labels are becoming overloaded with information making it difficult 
for  consumers  to  focus  on  the  essential  hazard  information.  A  recent  Eurobarometer  survey 
suggests that one or two of the hazard pictograms are not well recognised or understood by a 
majority of consumers.  

Within the framework of EU chemicals legislation, one of the primary mechanisms of hazard 
and  risk  communication  is  via  pictograms  and  product  labels  for  hazardous  chemicals  and 
mixtures, as prescribed by the CLP Regulation (and in line with the UN Global Harmonised 
System (GHS)). This means that that any changes agreed to at the GHS level (e.g. refinements 
to the wording of the hazard statements required on labels) are transposed into EU law via the 
CLP  Regulation.  There  are  also  a  small  number  of  additional  sector-specific  labelling 
requirements  (e.g.  for  cosmetics,  toys,  and  detergents).  In  addition,  the  EU  Ecolabel 
Regulation sets out rules for a voluntary labelling scheme. 

135 Biological availability in the context of Art. 12(B) CLP, 19th Meeting of Competent Authorities for REACH 
and CLP (CARACAL), 12 – 13 November 2015, Brussels, 03/11/2015, Doc. CA/90/2015 
136 Bioaccessibility testing (Bioelution) of metals, inorganic metals compounds and metals-containing materials: 
simulated  gastric  fluid,  Joint  Research  Centre,  European  Commission  2016  https://tsar.jrc.ec.europa.eu/test-
method/tm2016-02 

51 

 
 
                                                 
A recent Eurobarometer survey137 indicated that 70% of EU citizens find information on the 
hazards  of  chemicals  on  the  label  useful.  It  also  showed  that  there  are  varying  levels  of 
awareness and comprehension of the four (out of a total of nine) chemical hazard pictograms 
that  were  examined  by  the  survey.  While  'flammability'  is  well  recognised  and  understood 
(92% of respondents have seen it before and 96% could correctly state its meaning), it is less 
the  case  for  the  'environmental'  hazard  pictograms  (47%  of  respondents  have  seen  it  before 
and  83%  could  correctly  state  its  meaning),  'serious  health  hazard'  pictograms  (20%  of 
respondents have seen it before and 69% could correctly state its meaning), and 'exclamation 
mark' pictograms (63% of respondents have seen it before and 17% could correctly state its 
meaning). Nevertheless, when they see one of the chemical hazard pictogram on an unfamiliar 
product, most respondents (76%) read the safety instructions (57% read the safety instructions 
on the product label, while 19% say they go further by reading the safety instructions on the 
product  label  and  then  trying  to  find  further  information  from  other  sources).  The 
Eurobarometer  Survey  also  found  that  even  in  Member  States  where  understanding  of  the 
issues  surrounding  chemical  products  is  high,  the  comprehension  of  some  of  the  hazard 
pictograms is relatively low.  
At a more general level, another recent Eurobarometer survey138 found that less than half of 
the  respondents  (45%)  feel  well  informed  about  the  potential  dangers  of  the  chemicals 
contained in consumer products. However, again, this proportion varies considerably between 
Member States.  
Respondents to SME Panel consultation139 expressed the following views:  

  76% of respondents agreed or strongly agreed that the information currently required 

to be included on labels is necessary and appropriate. 

  78%  of  respondents  agreed  or  strongly  agreed  that  the  CLP  hazard  pictograms  are 

generally representative of the actual hazard.  

  63% of respondents agreed that consumers generally do not look beyond the label for 

hazard information and information on safe use.  

  29%  of  respondents  agreed  or  strongly  agreed  that  consumers  understand  the  CLP 
pictograms  and  information  provided  on  labels  regarding  the  safe  use  of  chemicals 
(against  41%  disagreeing  or  strongly  disagreeing  and  31%  neither  agreeing  nor 
disagreeing).  

  65% of respondents agreed or strongly agreed that employers and workers understand 
the  CLP  pictograms  and  information  provided  on  labels  regarding  the  safe  use  of 
chemicals.  

In part, this is an issue of citizen education and awareness raising by Member States. Hazard 
communication  to  workers  and  professional  users  is  considered  to  be  more  effective  with  a 
higher level of awareness, recognition and understanding of the pictograms than consumers; 
in part due to employee training.140  

137 Special Eurobarometer 456 
138 Special Eurobarometer 468 
139 1st FC Study, Annex V, p. 39 and onwards, question 11, table 2-19 
140 1st FC Study p. 70; see also1st FC Study workshop report p. 12-13 

52 

 
 
                                                 
Evidence  also  indicates  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.141  This  could  be  overcome  by  increasing  the  use  of 
digital  tools  to  communication  hazard  information.  61%  of  respondents  to  SME  panel 
consultation142  agreed  or  strongly  agreed  that  providing  information  on  chemical  hazards  to 
consumers should rely more on novel tools, such as QR-codes, apps and websites. Currently, 
however  the  legal  (mandatory)  requirements  do  not  incentivise  the  use  of  more  innovative 
techniques and digital tools and when it happens, industry is using digital tools on voluntary 
basis. While this may improve the understanding and management of hazards and risks, it can 
also  lead  to  confusion  between  the  CLP-required  and  the  sector-initiated  pictograms  and 
labels.  

Complementing  product  labelling,  Safety  Data  Sheets  (SDS)  are  a  key  communication  tool 
for downstream industry users of hazardous substances and mixtures towards workers.  Even 
though the CLP criteria are used to trigger the obligation to develop a SDS, provisions are in 
REACH. A SDS must provide information on all hazards covered by the CLP Regulation, as 
well  as  on whether  a  substance  or  mixture  meets the criteria  of  persistent,  bioaccumulative, 
toxic  or  very  persistent  and  very  bioaccumulative  (PBT/vPvB)  substances  or  on  substances 
included in the Candidate List of substances of very high concern (SVHCs). These provisions 
were  evaluated  as  part  of  the  REACH  evaluation  which  showed  that  there  has  been  a 
continued  increase  in  the  information  passed  through  the  supply  chain.  However,  the 
evaluation  also  pointed  out  a  relatively  high  level  of  non-compliance  and  highlighted  the 
potential  for  clarification  and  simplification  especially  for  SMEs.143  Another  factor  to 
consider is the capacity of SMEs to perform the risk assessment at the workplace based on the 
exposure scenarios provided in the safety data sheets (SDS) due to the limited resources and 
expertise. ECHA together with industry organisations developed a set of tools to simplify and 
harmonise  the  elaboration  of  exposure  scenarios  for  the  chemical  safety  report  and  their 
incorporation in the SDSs.144  

The  EU  has  established  two  alert  systems  to  enable rapid exchange  of  information  between 
Member States  and the EU authorities  in  emergency  situations when products,  food or  feed 
pose an immediate risk to health and safety of consumers. The Rapid Alert System for non-
food  dangerous  products  (RAPEX)145  is  an  effective  tool  for  allowing  public  authorities  to 
rapidly  take  appropriate  risk  mitigation  measures  for  consumer  goods  (toys,  textiles, 
cosmetics, etc.). Nevertheless, there is still room for further co-ordination of national market 

141 1st FC Study p. 24 and p. 70; see also Annex III, Section 7.3; Case Study 5; see also1st FC Study workshop 
report  p.  12-13;  see  also  Study  supporting  the  Evaluation  of  Regulation  (EC)  No  648/2004  (Detergents 
Regulation) p. 77-79, p.106 
142  
143 REACH Evaluation SWD(2018) 58 final p. 14-15, 28-29, 104, 131 
144 Many guideline documents are available on https://echa.europa.eu/safety-data-sheets 
145 See for example the DMF case (FC+ Study p. 105). DMF is a carcinogen antifungal agent used for furniture 
in South East Asia and included in furniture in small sachets placed on the EU market. DMF was identified as 
causing problems, signalled by a number of countries through RAPEX and ended up with a specific prohibition. 
See also 1st FC Study Annex VI Case Study 8 p. 11 and onwards for notifications regarding toys 

53 

 
 
                                                 
surveillance  activities  and  authorities  (i.e.  customs),  which  could  benefit  from  the  measures 
included  in  the  'Goods  Package'146.  In  a  similar  way,  the  Rapid  Alert  System  for  Food  and 
Feed  (RASFF)  provides  food  and  feed  national  control  authorities  with  an  effective  tool  to 
exchange  information  about  e.g.  undesirable  chemicals  in  food  causing  food  poisoning,  not 
labelled  allergens,  migration  of  chemicals  from  the  food  contact  material  into  food  such  as 
formaldehyde, plasticizers, volatile organic compounds etc.147  

5.2.5  Legislative gaps affecting the effectiveness  

The evaluation found a number of legislative gaps that affect the effectiveness of the chemical 
legislation. A more detailed assessment is provided in the relevant sections in the remained of 
this document as well in the Annexes Section 5.2.6:  

  combination effects (Relevance Section 8.1.2 1));   
  exposure to substances in articles (Relevance Section 8.1.2 3)); 
  protection of vulnerable groups (Coherence Section 7.2.B) 2) b));  
  endocrine disruptors (Coherence Sections 7.2. B) 1) b) and 7.2. B) 2) a) ii) as well as 

Annex 7.3).  

5.2.6  Application of the Precautionary Principle 

A. 

What's the issue? 

The precautionary principle is one of the three principles guiding environmental policy under 
the Treaty (article 191(2) of the TFEU). It allows for taking action when there is still a degree 
of  scientific  uncertainty  about  the  risk.  Whilst  the  precautionary  principle  has  not  been 
explicitly  defined  in  EU  legislation,  the  Commission  Communication  on  the  precautionary 
principle148 sets out steps to be followed in the decision making process. When applied in the 
chemicals policy area, this mechanism has two steps: 

1.  A  scientific  step,  where  the  responsible  scientific  body  (Agency  or  Committee) 
assesses  if  the  uncertainties  are  bigger  than  those  inherent  to  risk  assessment  of 
chemicals  and  if  the  consequences  of  those  uncertainties  could  lead  to  a  significant 
undesirable impact.  

2.  A  risk  management  step,  where  the  responsible  risk  management  body  (the 
Commission  and  the  associated  committees)  decide  what  action,  if  any,  is  required. 
Options  range  from  taking  no  action  to  precautious  and/or  restrictive  (e.g.  a  ban  of 
further use of a substance) measure, including gathering more data in order to reduce 
the level of scientific and risk assessment uncertainty. 

The  precautionary  principle  enables  a  rapid  response  to  be  given  in  the  face  of  potential 
significant  impacts  to  human,  animal  or  plant  health,  and  to  the  environment.  In  particular, 
where scientific data do not permit a complete evaluation of the risk, recourse to this principle 

146  (COM(2017)795).  Proposed  measures  include:  fostering  cooperation  among  national  market  surveillance 
authorities,  sharing  information  about  illegal  /  non-compliant  products  and  ongoing  investigations,  reinforced 
inspections of ports and external borders. 
147 https://ec.europa.eu/food/sites/food/files/safety/docs/rasff_annual_report_2016.pdf 
148 COM/2000/0001 final  

54 

 
 
                                                 
may,  for  example,  be  used  to  stop  distribution  or  order  withdrawal  from  the  market  of 
products likely to be hazardous.  

Whereas  both 
the  precautionary  and  prevention  principles  can  be  strictly  divided 
conceptually, it is not always straightforward to separate them as clearly in their application. 
Some  legal  instruments  based  on  a  general  preventive  approach  nonetheless  integrate  a 
precautionary approach for specific substances where risks to health and the environment or 
the thresholds needed to limit hazards are not identifiable (e.g. the Seveso III Directive aims 
at  prevention,  preparedness  and  response  to  accidents  involving  dangerous  substances  in 
industry  in  the  EU,  the  Industrial  Emissions  Directive  takes  into  account  the  whole 
environmental  performance  of  a  plant  through  granting  a  permit).149  The  precautionary 
principle  should  not  be  confused  with  the  element  of  caution  that  scientists  apply  in  their 
assessment  of  scientific  data  e.g.  generic  risk  management  approach  based  measures  and 
application  of  safety  factors  are  examples  of  preventative  action  and  not  the  application  of 
precautionary principle.  

Where scientific uncertainty is encountered, the challenge is in finding the correct balance so 
that  the  proportionate,  non-discriminatory,  transparent  and  coherent  actions  can  be  taken. 
Proportionality  also  covers  examination  of  the  benefits  and  costs  of  action/inaction.  It  is  a 
question of how effectively the EU chemical risk assessment and management processes are 
working in terms of detecting and acting upon early warnings and avoiding late lessons versus 
taking  over-precautious,  unnecessarily  restrictive  measures  and  unwarranted  recourse  to  the 
precautionary  principle,  as  a  disguised  form  of  protectionism.  Whatever  is  the  measure 
decided,  it  remains  subject  to  review,  in  light  of  new  scientific  data,  and  should  allow 
assigning  responsibility  for  producing  the  scientific  evidence  necessary  for  a  more 
comprehensive risk assessment. 

B. 

What are the findings? 

Conclusions 

The  inherent  uncertainty  created  by  the  difficulty  in  determining  the  exact  level  to  which 
exposures  to  hazardous  chemicals  can  be  attributed  to  human  health  and  environmental 
impacts  (when  this  is  just  one  factor  amongst  a  number  of  confounding  factors  (lifestyles, 
genetic  predisposition,  habitat  degradation,  climate  change,  etc.))  presents  particular 
challenges  for  the  chemical  risk  management  decision  makers.  Although  the  precautionary 
principle  is  explicitly  taken  into  account  in  the  design  of  various  pieces  of  chemicals 
legislation, to date, it has actually been applied in very few instances in the chemicals policy 
area.  Whilst  it  does  not  mean  that  actions  must  be  taken  systematically,  a  number  of 
stakeholder  groups  expressed  concerns  that  risk  management  decision  makers  err  towards  a 
wait-and-see  approach  whilst  more  data  is  gathered  to  reduce  the  level  of  uncertainty.  The 
Bisphenol A case shows, however, that this is not always the case.  

The precautionary principle is explicitly taken into account in the design of various pieces of 
chemicals  legislation  (e.g.  those  requiring  safety  assessments  such  as  the  Biocidal  Products 
Regulation and the Plant Protection Products Regulation, the Water Framework Directive, the 
Persistent Organic Pollutants (POPs) Regulation and the Restriction of Hazardous Substances 

149 The precautionary principle in EU environmental policies; Final Report, November 2017; Milieu Ltd; p. 93 

55 

 
 
                                                 
in  Electrical  and  Electronic  Equipment  (RoHS  Directive),  as  well  as  REACH  (many 
persistent,  bioaccumulative  and  toxic/very  persistent  and  very  bioaccumlative  substances 
(PBTs/)vPvBs are regulated on precautionary basis)).  

The  following  examples  show  cases  where  the  precautionary  principle  was  applied  (non 
exhaustive): 

  The  “Community  strategy  for  endocrine  disruptors”  adopted  in  1999  and  updated  in 

2001, 2004 and 2007.  

  Ban of Bisphenol A (BPA) in polycarbonate infant feeding bottles in 2011.  
  Setting  lower  specific  migration  limit  for  Bisphenol  A  for  varnishes  or  coatings 
applied to materials and articles intended to come into contact with food in 2018.150 

A  number  of  stakeholder  groups  including  NGOs,  trade  unions,  and  some  Member  State 
Competent Authorities have  raised concerns that in the assessment of chemicals, authorities 
often  hesitate  to  introduce  risk  management  measures  in  situations  where  the  precautionary 
principle  applies  and  prefer  to  wait  and  request  additional  data  to  reduce  the  level  of 
uncertainty.151 The BPA case shows however that this not always the case. Indeed, while still 
facing uncertainties including about the potential replacement substances and their safety and 
effectiveness, the Commission has mandated EFSA to undertake a full re-evaluation of BPA 
on  the  basis  of  the  results  of  anticipated  new  studies  and  scientific  data.  Following  the 
principles  established  in  the  2000  Communication  mentioned  above,  the  Commission  will 
then decide what and if any further action is necessary to protect consumers.  

5.2.7  Balance  and  Mix  Between  the  Risk  Management  Measures  based  on 

'Generic' and 'Specific' Risk Considerations 

A. 

What's the issue? 

Risk management measures in the EU chemicals legislation are taken based on an assessment 
of the risks to human health or the environment associated with the exposures to hazardous 
chemicals. As described in more depth in Section 2.1.5 and Annex 8 Section 8.2.1, there are 
two  basic  approaches  to  risk  management  used,  often  in  combination,  in  the  EU  chemicals 
acquis: one based on specific risk assessment (SRA) approach and one based on generic risk 
consideration (GRC). Under the GRC approach, exposure scenarios are assessed generically 
based  on  the  hazard  of  a  substance  or  mixture  without  considering  specific  exposure 
situations. Under the SRA both the hazard of and the potential specific exposure scenarios of 
humans and the environment to the substance or mixture in question are assessed at the same 
time. 

150  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 
151  This  situation  is  illustrated  by  the  outcome  of  risk  assessment  carried  out  in  2001  and  2003  for  penta-
brominated  diphenyl  ether  (PBDE)  and  octa-brominated  diphenyil  ether  (OBDE)  which  led  to  a  ban  in  2004 
(under  the  legislation  preceding  REACH  though).  At  the  same  time,  for  deca-BDE  it  was  decided  to  proceed 
with  the  scientific  research  required  to  resolve  the  uncertainty,  rather  than  take  a  precautionary  approach. 
However, on the basis of the evidence gathered after the additional testing, it was decided to ban deca-BDE in 
2008. Source: The precautionary principle in EU environmental policies; Final Report, November 2017; Milieu 
Ltd; p. 50 

56 

 
 
                                                 
B. 

What are the findings? 

Conclusions 

Generic  and  specific  risk  management  approaches  both  have  their  role  to  play  within  the 
framework of EU chemicals legislation but the application of both approaches has room for 
improvement.   

Findings of this Fitness Check show that both the GRC and SRA have their role to play in the 
EU  chemical  legislative  framework  and  that  the  current  balance  between  the  use  of  generic 
and specific risk management approaches works well, each under particular circumstances. 

Advantages 

Drawbacks 

Generic Risk 
Considerations 
(GRC) 

Provide  a  clear  signal  to  all  the  actors 
involved (enforcement authorities, industry 
and  downstream  users)  on  the  types  of 
hazardous  substances  which  should  be 
avoided  

lead 

Automatically  triggered  risk  management 
measures  may 
to  disproportionate 
outcomes  and  unintended  (legal  and/or 
a 
socio-economic) 
mechanism  for  derogation  is  absent  or  not 
appropriate  

consequences 

if 

The  outcome  of  the  risk  management 
decision  making 
is  more 
predictable (compared to SRA)  

process 

Potential  consequences  of  automatically 
triggered  measures 
downstream 
legislation  might  influence  the  upstream 
scientific debate leading to the classification  

in 

Might  be  more  appropriate  for  substances 
of  higher  concern  and  where  vulnerable 
populations  are  at  risk  and/or  cannot  be 
protected through e.g. training or protection 
equipment  (e.g.  children  under  the  Toy 
Safety Directive) 

Less  appropriate  where  exposures  are 
minimal  or  would  not  occur  through  the 
route  of  exposure  of  concern  and  therefore 
can lead to over-regulation for non-relevant 
routes of exposure  

Specific Risk 
Assessments 
(SRA) 

Allow  more  targeted  and  differentiated 
consideration  of  exposures  and  thus  risks 
and 
appropriate 
identification  of  actual  risks  and  of  risk 
management measures 

therefore 

more 

The  process  might  be  slower  compared  to 
GRC and often more costly 

Allow more targeted consideration of costs 
and  benefits  of  various  risk  management 
options 

Predictability of risk management decisions 
can be more difficult 

Table 2 Main comments received from stakeholders regarding the GRC and SRA application 

Where a derogation mechanism is connected to the GRC approach (i.e. a derogation from e.g. 
an  automatic  restriction  or  ban  if  certain  conditions  are  fulfilled,  such  as  demonstration  of 
negligible  exposure),  industry  stakeholders  stated  that  it  helps  to  ensure  that  the  risk 
management measure stipulated will not lead to disproportionate costs or unintended effects 
e.g.  regrettable  substitutions.  The  process  of  issuing  derogations,  including  their  specified 

57 

 
 
 
limitations,  requirements  and  justifications,  was  considered  useful  by  various  industry 
stakeholders as the flexibility is necessary to the implementation of legislation.152  
Respondents to the public consultation153 were invited to indicate to what extent they find that 
the chemicals legislation framework overall should be more oriented towards SRA, GRC or 
should  remain  as  it  is.  The  preferences  of  the  different  groups  varied  quite  considerably. 
Industry  and  in  particular  bigger  companies  tended  to  prefer  a  more  extensive  use  of  SRA 
approaches while NGOs tended to have a higher preference for more GRC approaches. The 
most  common  response  among  Member  State  competent  authorities  was  that  the  current 
application  of  GRC  and  SRA  approaches  within  the  framework  of  the  EU  chemicals 
legislation is well balanced and should remain as it is. Responses from citizens were mixed, 
providing  equal  support  for  more  SRA  and  for  more  GRC  approaches,  but  a  majority  of 
citizens (ca. 60%) did not know how to answer or did not provide an answer to the question. 
Respondents  were  also  asked  to  provide  comments  on,  or  arguments  for,  their  preference; 
these are summarised in Annex 5 Section 2.8.  

During the FC+ Study workshop, participants agreed that both approaches have their merits 
depending  on  the  case  at  hand.  There  was  no  conclusive  agreement  on  which  one  is  to  be 
preferred154.  
During  the  1st  FC  study  workshop,  one  of  the  topics  discussed  was  the  appropriatness  and 
impacts  on  the  existing  linkages  between  the  CLP  and  the  relevant  pieces  of  downstream 
legislation affected by harmonised classifications under CLP and that trigger risk management 
requirements. The following views were expressed155: 

  Automatic  triggers  provide  legal  certainty  and  a  quick,  high  level  of  protection 
(particularly for cumulative risks). The focus should be on when the use of hazardous 
chemicals should be allowed (for example, when exposure is controlled), rather than 
the  other  way  around,  meaning  an  automatic  ban  with  possible  derogations  is 
preferable. Another participant noted that for some classifications there should be no 
derogation.  

  Other  participants,  however,  expressed  severe  criticism  against  hazard-based  risk 
management measures, which was seen as giving the European industry a competitive 
disadvantage  vis-à-vis  the  rest  of  the  world.  In  this  respect,  some  argued  that  any 
hazard should only trigger risk assessment, with risk management measures (RMMs) 
then  identified  based  on  this.  Consequently,  if  there  is  a  change  in  the  hazard 
classification the RMM currently required should be re-assessed.  

  There are also arguments in favour of a more mixed approach, which would allow for 
automatic triggers appropriate under some legislation (where justified) but  not under 
other legislation. 

152 FC+ Study p. 96 
153 1st FC Study, Annex V, p. 94-102; public consultation Question 14 
154 FC+ Study workshop report p. 18 
155 1st FC Study workshop report p.18 

58 

 
 
 
                                                 
6  EFFICIENCY  

6.1  Evaluation  question:  what  are  the  costs  and  benefits  associated  with 
the  implementation  of  the  legislative  framework  for  chemicals?  What 
are the key drivers for those costs and benefits? To what extent are the 
costs proportionate to the benefits?  

In addition to examining the costs and benefits associated with the implementation of the EU 
legislative  framework  for  chemicals,  the  analysis  provided  below  also  looks  at  whether  the 
costs  are  proportionate  to  the  benefits.  Annex  6  and  Annex  11  provide  a  more  detailed 
overview of the costs and benefits identified by the Fitness Check.  

6.1.1  Costs and cost drivers 

A. 

What's the issue? 

The  efficiency  of  the  EU  chemicals  legislation  in  achieving  its  three  core  objectives  is 
examined by analysing: 

the direct regulatory costs and the enforcement costs; 

 
  drivers for these costs; and  
  who is facing these costs.  

Indirect  costs  and  the  costs  of  risk  management  measures  triggered  under  the  downstream 
legislation  are  not  assessed  here,  but  the  Fitness  Check  does  consider  those  processes  and 
whether they are working properly (see Section 5 Effectiveness). Given the differences in the 
organisation  of  public  administrations  across  the  EU,  enforcement  costs  imposed  on  public 
authorities  at  national  level  are  analysed  from  a  cost  drivers'  perspective  (i.e.  not  providing 
monetised and quantified figures).  

B. 

What are the findings? 

Conclusions 

The  methodological,  counterfactual  and  data  challenges  make  it  unfeasible  to  provide  a 
quantified  estimate  of  the  overall  costs  of  the  EU  chemicals  legislation.  However,  an 
assessment of the CLP Regulation indicates the on-going annual regulatory costs to industry 
in  the  EU  range  from  EUR  0.97  to  1.7  billion.  Similarly,  the  annual  regulatory  costs  for 
industry  due  to  the  Plant  Protection  Products  Regulation  are  estimated  at  EUR  122-189 
million.  The  annual  regulatory  costs  for  industry  due  to  the  Detergents  Regulation  are 
estimated at EUR 63.7-149 million). This would suggest that the overall regulatory costs of 
the EU chemicals legislation for EU industry are several billion euros per year. Quantitative 
and qualitative analysis suggests that regulatory costs have remained relatively stable over the 
last decade.  

Depending  on  the  piece  of  legislation,  the  main  cost  drivers  are  data  generation  (hazards, 
chemical uses, exposures, etc.), staff and worker occupational hygiene monitoring and control 
costs,  as  well  as  enforcement  and  monitoring  costs  for  public  authorities.  SMEs  are  more 
affected  than  bigger  companies  by  certain  aspects  of  the  EU  chemicals  legislation  such  as 
understanding and compliance with legal obligations. The overall pace of the risk assessment 

59 

 
 
and risk management processes can also have significant implications for the costs borne by 
both industry and the public authorities (at both the EU and at Member States levels). 

The regulatory costs assessed for the purposes of this Fitness Check cover: 

  Direct  regulatory  costs  affecting  the  EU  chemicals  industry,  downstream  users  and, 
which may end up being passed onto consumers to greater or lesser extent. These costs 
correspond  to  regulatory  charges,  substantive  compliance  costs  and  administrative 
costs.  
Implementation and enforcement costs affecting public authorities both at the EU and 
Member State level. 

 

The baseline used is a simple counterfactual of no EU or Member State chemicals legislation. 
As explained above (Section 4.2), it was challenging to quantify the overall cumulative costs 
of the EU chemicals legislation.  

1) 

Direct regulatory costs  

a) 

Overview  

All stakeholders recognise that the costs of the chemicals legislation are significant, especially 
for  SMEs156  with  a  perception  of  costs  that  varies  depending  on  the  stakeholder  group  i.e. 
industry, NGOs, public authorities, citizens157.  

An estimate was made of the cost of the EU legislation with a bearing six subsectors of the 
chemical industry during the period 2004-2014 (see Annex 6 Section 6.1.2 Table 12 for the 
list of pieces of legislation covered). When added up, the estimated average annual total direct 
cost borne was around EUR 8 billion, representing around 1.7% of their turnover and 9% of 
the value added.158  

Among  the  legislation  packages,  the  emissions  and  industrial  processes  package  represents 
approximately 33% of the regulatory cost (4% of the subsectors’ value added), the chemicals 
package (including REACH) 29% (3.5% of value added) and workers’ safety 24% (2.9% of 
value  added).159  Whilst  there  are  different  estimates,  quantitative  and  qualitative  analysis 
suggests that regulatory costs have remained relatively stable over the last decade.160  

However, the figure of EUR 8 billion cannot be considered as an entirely accurate estimate of 
the cost of the chemicals acquis due differences of scope and in the methodology applied: 

156 1st FC Study, Annex V, p. 138; public consultation Question 20 
157  Among  the  most  significant  costs,  industry  considers  costs  of  understanding  and  keeping  up  to  date  with 
changes in legal requirements as particularly significant, whereas other stakeholder groups consider this to be a 
less  significant  part  of  overall  costs.  Similarly,  training,  inspections  and  administrative  requirements  are 
perceived  as  more  significant  by  industry  compared  to  other  stakeholder  groups.  Risk  management  measures, 
and to a slightly lower degree labelling and packaging requirements are considered of high cost significance by 
all actors. Classification requirements are perceived to be relatively significant by industry and public authorities 
but to a lesser degree by NGOs/others. 
158 CCA1 Study p. 8-12 
159 Annex 6 Table 1 provides a list of pieces of legislation per legislative package   
160 CCA1 Study p. 114  

60 

 
 
                                                 
  The  period  covered  (2004-2014)  corresponds  only  partly  to  the  one  covered  by  this 

Fitness Check. 

  Costs  correspond  to  only  six  subsectors  (organic  and  inorganic  basic  chemicals, 
plastics in primary forms, pesticides and agrochemical products, soaps and detergents, 
paints,  varnishes  and  similar  coatings  and  other  chemicals  products)  and  not  all  the 
industry and companies. 

  Costs  presented  above  also  include  regulatory  costs  for  several  pieces  of  legislation 
that  are  not  in  the  scope  of  this  Fitness  Check.  In  addition,  several  other  pieces  of 
legislation although within  the scope of this Fitness Check, were  not  covered by the 
abovementioned  cumulative  cost  assessment  attempt.  Please  see  Annex  6  Section 
6.1.2 Figure 13 for a full list of pieces of legislation covered. 

  While the occupation safety and health (OSH) Framework Directive, per se, is not in 
the scope of this Fitness Check, it can be reasonably assumed that the costs related to 
occupational  health  and  safety  legislation  in  the  chemicals  sector  derive  primarily 
from  the  daughter  regulations  (the  Chemical  Agents  Directive,  the  Carcinogens  and 
Mutagens Directive, etc.) which are within the scope of the Fitness Check. That said, 
it should also be noted that the estimated occupational health and safety costs probably 
include costs of worker safety protection beyond specific risks posed by exposure to 
hazardous  chemicals(e.g.  falls  from  heights,  electrocution,  burns,  etc.)  which  are 
substantive but are not within the scope of the Fitness Check.   

  Regarding  the  emissions  and  industrial  processes  legislative  package,  it  should  be 
noted  that  the  EU  Emission  Trading  System  (ETS)  related  legislation  is  not  in  the 
scope  of  this  Fitness  Check.  In  this  legislative  package,  most  of  the  monetary 
obligations are due to ETS. Therefore, the regulatory costs of emissions and industrial 
processes legislative package as assessed for the purposes of this Fitness Check can be 
estimated to represent EUR 2.6 billion (instead of EUR 3.1 billion).   

Therefore, additional cost elements were gathered where possible and qualitative assessment 
is presented where providing reliable quantified figures was considered to be impossible.   

b) 

Regulatory charges  

Regulatory charges are the fees, levies or taxes imposed by the legislation, primarily faced by 
industry  (see  Annex  6  Section  6.1.2.  A)  table  13  providing  a  list  of  regulatory  charges  by 
piece of legislation). Fees and charges are, in general, set using the cost recovery principle i.e. 
they correspond to the actual cost of the work involved and services delivered.  

While  creating  business  opportunities  for  innovative  and  specialised  SMEs,  understanding 
and complying with the chemicals legislation remains a key challenge for them.161 Therefore, 
mitigating  measures  such  as  reduced  fees  have  been  introduced  under  some  pieces  of 
legislation (the CLP Regulation, the Biocidal Products Regulation). However, the SMEs fee 
reduction mechanism does  not exist  under all pieces of legislation (e.g. the Plant Protection 
Product Regulation, the Waste legislation, the Residues of Pesticides Regulation, the Export 

161 In the Commission Communication "Commission follow-up to the 'TOP TEN' Consultation of SMEs on EU 
Regulation", SMEs were reported to "have concerns about the complexity and cost of information obligations, 
inconsistent  application  by  Member  States  and  a  lack  of  coherence  with  specific  chemicals  legislation".  See 
COM(2013) 446 final, 18 June 2013 

61 

 
 
                                                 
and Import of Hazardous Chemicals Regulation, the Detergents Regulation and the Fertilizers 
Regulation). The use of this tool remains uneven across the EU where it can be applied as in 
most cases it is up to Member States to define the level of fee reduction162.  

c) 

Substantive compliance costs 

Substantive compliance costs can be divided into:  

  One-off costs that are often borne by a particular regulated group e.g. manufacturers, 
having  to  adjust  and  adapt  to  the  changes  in  legal  rules.  The  transition  from  the 
Dangerous Substances Directive (DSD) and Dangerous Preparations Directive (DPD) 
to the CLP Regulation generated one-off costs estimated ex-post to range from EUR 
0.9  -  2.2  billion.163  Such  costs  were  generated  mainly  by  the  (re-)classification 
obligation  and  changes  to  be  made  in  order  to  comply  with  the  new  labelling  and 
safety  data  sheet  requirements.  Transition  costs  can  also  occur  where  substance 
specific risk management measures are taken e.g. a ban of a substance that is classified 
as  carcinogenic,  mutagenic  or  toxic  for  reproduction  (CMR)  which  requires 
manufacturers  to  reformulate  and,  in  some  instances,  to  stop  the  manufacture  of  a 
particular  product  line  altogether.  Costs  can  be  very  low,  for  example,  where  a 
substitute  is  readily  available,  and  significantly  higher,  where  it  is  not,  or  where 
reformulation involves significant change to the production process164. 

  Recurrent costs that are sustained by the regulated stakeholders on regular basis. The 
importance of these costs depends on the overall complexity of legislation. The main 
cost  drivers  for  recurrent  costs  are  the  obligation  to  generate  and  provide  data  for 
chemical  hazard  classification  (including  testing),  the  risk  assessment  step,  in 
particular  the  exposure  assessment  element,  as  well  as  the  implementation  of  risk 
management  measures  e.g.  hazard  communication  through  labelling165.  The  costs  of 
the  classification  of  a  substance  are  driven  mainly  by  the  CLP  Regulation.  Annual 
costs  arising  from  the  CLP  Regulation  are  estimated  to  amount  to  EUR  1.3  billion 
(EUR  0.97-1.7  billion).166  Costs  are  often  dependent  on  data  availability  and 
usability167.  Costs  of  data  generation  and  risk  and  exposure  assessment  are  often 
related  to  an  authorisation/approval/renewal  process  e.g.  under  the  Plant  Protection 
Products  and  Biocidal  Products  Regulations  and  can  be  significant  cost  drivers.  The 
total  costs  for  the  pesticides  industry  are  estimated  at  approx.  EUR  122-189  million 

162  The  level  of  fee  reduction  should  still  reflect  the  cost  recovery  principle,  i.e.  the  fee  or  charge  need  to 
correspond to the actual cost of the work involved, and to cover the cost of the services delivered. 
163  Estimates  based  on  the  number  of  substances  (over  99  000)  and  the  number  of  mixtures  (2  –  2.5  million) 
subject to reclassification, labelling and safety data sheets preparation. Source: 1st FC Study p. 45 and Annex II 
p. 58-85 
164 1st FC Study p. 49-51 
165 FC+ Study p. 79-84 
166 1st FC Study, p. 48. It was not possible to identify what is the share of classification, as the EUR 1.3 billion 
figure  includes  direct  costs  for  industry  from  hazard  identification,  classification,  labelling  and  packaging, 
annual up-dates to IT systems in line with adaptations to CLP and new harmonised classifications (CLH), staff 
training costs, ongoing compliance activities, hassle costs and packaging related costs. (Source: 1st FC STUDY 
Annex II, p. 95) 
167 In general, when data are publicly available, the risk/hazard assessment process overall is easier. Similarly, 
low data access and usability affects costs upward. (Source: FC+ Study p. 79-84). 

62 

 
 
                                                 
per year. The regulatory charges (fees) represent a small share of the total costs for the 
industry  Study  supporting  the  REFIT  Evaluation  of  the  EU  legislation  on  plant 
protection  products  and  pesticides  residues  (Regulation  (EC)  No  1107/2009  and 
Regulation  (EC)  No  396/2005)  p.126;  not  yet  publicly  available.168  The  costs  for 
pesticides maximum residue level (MRLs) procedures are estimated at around EUR 55 
million  per  year  for  the  industry169.  Annual  costs  that  the  detergents  industry  has 
incurred as a direct result of the Detergents Regulation are estimated to range between 
EUR 63.7 – EUR 149 million (appr. EUR 764 million – EUR 1.8 billion in total since 
2005).170  Depending  on  the  sector,  compliance  with  occupational  health  and  safety 
legislation, e.g. investments in workers’ health protection equipment, can also lead to 
significant costs.  

"Understanding  and  keeping  up-to-date  with  changes  in  legal  requirements"  was  identified 
during the public consultation and the SME Panel Survey as a significant driver of costs by 
the highest number of companies (84% (147) of companies for the former and 45% of SME 
respondents for the latter), with the costs of risk management under the different legislation 
ranked second (73% or 127).171 Training staff to ensure compliance with legal requirements 
was  also  identified  as  important  cost  driver  (61%  (106)  by  respondents  from  Industry 
association and companies). 

SME  stakeholders  underlined  the  fact  that  SME  specific  challenges  are  often  linked  to  the 
availability  of  resources.  For  SMEs,  it  is  difficult  to  find  the  time  and  money  to  attend 
workshops, webinars, conferences, etc. (especially if information is only available in English), 
and  to  find  the  necessary  time  to  track,  understand  and  implement  the  many  and  often 
complex requirements of the EU chemicals legislation and to keep up-to-date with changes to 
the requirements. From an authority and industry association perspective, it can be difficult to 
reach  smaller  companies.  There  are  also  differences  in  the  support  to  SMEs  provided  by 
Member  States.  There  was  a  general  view  amongst  the  SME  stakeholders  consulted  that 
Member States need to do more.172  

d) 

Administrative costs 

Administrative  costs  are  those  borne  by  businesses,  citizens,  civil  society  organisations  and 
public authorities in complying with information obligations. They include173: 

 
 

the obligation of reporting; and 
retrieving  data  on  applications  from  downstream  users  and  labelling  (also  discussed 
under the section on substantive regulatory costs above). 

168  Study  supporting  the  REFIT  Evaluation  of  the  EU  legislation  on  plant  protection  products  and  pesticides 
residues (Regulation (EC) No 1107/2009 and Regulation (EC) No 396/2005) p.126; not yet publicly available 
169 Ibidem    
170 The largest costs are calculated to have arisen as a result of the need to use different raw materials in place of 
phosphorus,  from  having  to  provide  ingredient  datasheets  to  poison  centres  and  from  the  research  and 
development necessary for reformulation (to reduce the total phosphorus content of consumer laundry detergents 
and  consumer  automatic  dishwasher  detergents  (CADD)).  (Source:  Study  supporting  the  Evaluation  of 
Regulation (EC) No 648/2004 (Detergents Regulation), p. 157) 
171 1st FC study p. 48 
172 1st FC Study workshop report p. 19-21 
173 CCA1 Study p.110  

63 

 
 
                                                 
Estimates of the costs of reporting by Member States to the EU level were made as part of the 
“Fitness Check of Reporting and Monitoring of EU Environment Policy”.174 These varied by 
piece  of  legislation:  for  example,  the  CLP  Regulation  and  the  Asbestos  Directive  were 
between  EUR  30  000  and  100  000  per  annum;  the  Persistent  Organic  Pollutants  (POPs) 
Regulation  and  the  Regulation  on  Export  and  Import  of  Hazardous  Chemicals  were  under 
EUR 30 000 per annum. 

Another factor that could increase the administrative costs is the pace of the processes for the 
specific  risk  assessments.  Under  the  EU  chemicals  legislation,  the  expected  duration  of  the 
risk  assessment  procedure  ranges  between  several  months  and  several  years  e.g.  the  risk 
assessment and authorisation procedure for active substances in plant protection products and 
products  lasts  at  least  12  months175.  The  longest  average  duration  of  a  risk  assessment  is 
attributed, according to the stakeholders consulted, to the Biocidal Products Regulation and to 
the  Plant  Protection  Products  Regulation.  According  to  these  stakeholders,  the  process  of 
regulatory  validation  can  take  up  to  10-15  years176,  due  to  delays  both  from  the  industry 
applicant  in  submitting  missing  data  and  from  the  evaluating  authorities.  For  the  Biocidal 
Products  Regulation,  one  could  note  however  that,  in  most  cases,  industry  can  place  their 
substances/products  on  the  market  during  the  assessment  period  by  authorities,  which  also 
allows them to recover some costs during that period. 

2) 

Enforcement costs 

Legal  rules  have  to  be  monitored  and  enforced  by  public  authorities  to  be  effective  which 
implies costs. It is not possible to provide quantified figures for costs of enforcement of the 
EU  chemicals  legislation  at  national  level.  These  costs  will  vary  across  legislation  and  also 
depend  on  the  regulatory  option  chosen  (e.g.  self-regulation,  providing  information  and 
guidelines,  market-based  instruments,  more  or  less  stringent  and  prescriptive  regulatory 
actions).  Enforcement  costs  will  also  vary  across  Member  States  depending  on  the  national 
administrative choices and the related functional costs.177   
The costs for public authorities178 include costs associated with: 

 

Implementation  activities:  participation  in  expert  groups  and  scientific  bodies, 
research  and  regulatory  proposals,  risk  assessments,  etc.  is  time-  and  resource-
intensive. Therefore, the fact that many Member States are lacking resources leads to 
differences in their involvement in bringing forward harmonised hazard classification 
dossiers under the CLP Regulation, for example.    

  Compliance  monitoring  and  enforcement  activities:  costs  will  depend  on  the  way  in 
which  this  is  organised  at  the  national  level.  For  example,  data  available  from  the 
REACH-EN-FORCE179  projects  indicate  that  on  average  over  2  000  inspectors  are 

174 SWD(2017)230 p.26-27 
175 https://www.efsa.europa.eu/sites/default/files/applications/apdeskapplworkflowpesticidesnasub.pdf 
176 FC+ Study p. 82 
177 Quantification of costs incurred in the EU were carried out only in respect to the CLP Regulation. See 1st FC 
Study Annex II p. 211 
178 1st FC Study p. 51 
179  https://echa.europa.eu/about-us/who-we-are/enforcement-forum/forum-enforcement-projects 

64 

 
 
                                                 
trained  on  REACH  and  the  CLP  per  annum  in  the  EU,  at  an  annual  cost  of  around 
EUR 1.7 million.180  

For  illustrative  purposes,  the  overall  costs  for  Member  States  generated  by  the  Plant 
Protection Products Regulation for the approval and authorisation procedures are estimated at 
approx. EUR 44 million annually. The costs for the Residues of Pesticides Regulation (which 
sets  maximum  residues  levels  (MRLs)  of  pesticides  on  food  products)  procedures  are 
estimated at around EUR 5 million annually for the 28 Member States.181 

At the EU level, the average annual costs to ECHA associated with implementing the CLP are 
approximately  EUR  2.57  million182.  This  figure  is  the  cost  of  providing  guidance,  running 
helpdesks, overseeing committees and forums, etc. The total cost to ECHA of implementing 
the CLP over the period 2010 to 2016 was over EUR 22.8 million, equivalent to 17% of the 
combined REACH and the CLP budget.183 The total capital costs to ECHA of developing the 
Classification  and  Labelling  Inventory  (CLI)  were  around  EUR  1  million,  with  an  annual 
operating expenditure of around EUR 0.2 million.184 

The  costs  for  MRLs  procedures  are  estimated  at  around  EUR  3  million  for  EFSA  and  the 
Commission. 

6.1.2  Benefits  

A. 

What's the issue? 

The efficiency of the EU chemicals legislation is the ratio of the benefits to the costs. Having 
looked at the costs, this section looks in a similar way at:  

  What are the benefits of the EU chemicals legislation?   
  How significant are these benefits and what are the key drivers? 
  To whom do the benefits accrue? 

Data, knowledge and methodological gaps mean it was not possible to arrive at a cumulative 
'monetised'  benefit  estimate  for  the  whole  framework  of  the  EU  chemicals  legislation. 
Nevertheless, certain components of the broader picture are presented below. It is important to 
recognise, however, that these benefit estimates represent just a portion of the overall health 
and environmental benefits of the EU chemicals acquis.  

B. 

What are the findings? 

Conclusions 

The EU chemicals legislation has clearly led to significant benefits in terms of avoided health 
and environmental impacts. Some of the most notable benefits relate to reduced exposure to 
hazardous chemicals at the workplace known to increase the risk of cancer and cardiovascular 
disease. Key benefit drivers include avoided healthcare costs, avoided productivity losses (due 

180 1st FC Study p. 88 
181 European Chemicals Agency, Budget 2018    
182 European Chemicals Agency, Budget 2018    
183 1st FC Study p. 52 
184 1st FC Study p. 46  

65 

 
 
                                                 
to avoided lost working hours as a result of illness or premature death), avoided suffering and 
premature  deaths,  avoided  remediation  costs  (including  wastewater  and  drinking  water 
treatment costs) and avoided degradation of environmental/eco-system services costs. 

Significant  benefits  in  terms  of  protecting  human  health  and  safeguarding  the  environment 
have  been  delivered  over  the  last  50  years  by  the  EU  chemicals  legislation  to  industry,  to 
public authorities and regulators as well as to consumers and citizens and to society and the 
economy more generally. Table 3 provides a list of the main categories of benefits and direct 
beneficiaries.  

Benefits 

Direct beneficiaries 

Workers, 
consumers 
and citizens 

'Physical' 
benefits 

Reduced morbidity and mortality health impacts (e.g. reduced number 
of  cancers,  cardiovascular  diseases,  allergies,  reproductive  illnesses, 
neurological  diseases,  etc.)  from  reduced  exposures  to  hazardous 
chemicals. This includes avoided suffering and health effects through 
higher  income  (due  to  avoided  lost  earnings  as  a  result  of  avoided 
illness) and longer life expectancy 

Health 

Consumers 
and citizens 

Avoided  healthcare  costs,  avoided  suffering  (assessed  through 
willingness to pay techniques), value of avoided life years lost due to 
premature death, productivity losses due to lost work hours as a result 
of illness and/or premature death 

Monetised 
benefits 

Industry 

Member 
States 

Society 

Industry 

Avoided 
environmental 
damage 

Avoided  health  costs  and  productivity  losses;  a  less  hazardous 
working  environment  can  reduce  the  costs  that  companies  face 
(healthcare costs, insurance costs, lost productivity, fines, etc.) 

Reductions  in  the  damage  costs  associated  with  chemical  exposures 
(healthcare costs, environmental clean ups, etc.) 

Various  ecosystem  services,  recreational  values,  increased  fishing 
revenues and avoided water treatment costs  

Reductions  in  the  costs  associated  with  environmental  remediation 
and clean ups. Improved access to and reduced costs of clean water, 
etc. 

Members 
States 

Reductions  in  the  costs  associated  with  environmental  remediation 
and clean ups.  

Regulatory 

Member 
States 

Reductions  of  some  of  the  burden  faced  by  Member  States,  by 
enabling them to share efforts (and hence resources) at the European 
level in the implementation of the legislative framework  

Table 3 Benefits of the EU chemicals legislative framework and direct beneficiaries 

Some of the biggest, currently measurable, health benefits of the EU chemicals legislation are 
associated with reductions in the exposure to carcinogenic substances. However, one should 
keep in mind that, while the extent of cancer incidence due to occupational exposure has been 
extensively  studied,  the  impacts  from  environmental  exposure  to  carcinogens  are  harder  to 
estimate. It is in an occupational setting where the link between exposure to certain chemicals 

66 

 
 
and cancer is the most clear185. Based on reductions in exposure to a group of 13 carcinogens 
since 1995 that have been targeted by EU occupational health and safety legislation, the total 
number of cancer deaths avoided across the EU is estimated to be around 1.4 million.186 Other 
examples  include  the  estimated  benefits  from  a  reduced  exposure  to  hexavalent  chromium, 
phthalates, to pesticides and polychlorinated biphenyls (PCBs) (see Table 4 below as well as 
Annex 6 Section 6.1.3. B) Table 15 for additional examples).  

What's Included? 

Time period  

Legislation  

  Avoided 

2000-2008 

healthcare costs 

  Avoided 

productivity 
losses (lost 
working hours 
and income) 

Since 2008  

1995 - 2010 

1996 - 2008 

Estimated 
Benefit Value 
(€) 
for the EU 
EUR 391 – 512 
million/yr  

EUR 217 – 338 
million/yr 

Benefits 

Reduced 
poisoning 
incidents, 
occupational skin 
and respiratory 
diseases and 
occupational 
cancers187 
Reduced exposures 
to hexavalent 
chromium at 
workplace188  

EUR 100 
million/yr  
EUR 4 billion in 
total  

Avoided cancers: 
  Avoided 

healthcare costs 

  Avoided 

productivity 
losses (lost 
working hours 
and income) 

  Avoided 

suffering/death
189  
Reduced 
female/male 
reproductive 
disease: 
  Avoided 

healthcare costs 

  Avoided 

productivity 
losses (lost 
working hours 
and income) 

Reduced exposure 
to phthalates 
(DEHP; DBP) via 
a variety of 
consumer 
products190

DEHP: 
EUR 7 billion 
cumulatively 
from (i.e. approx. 
EUR 580 
million/yr) 
DBP: 
EUR 6.7 billion 
cumulatively (i.e. 
approx. EUR 560 
million/yr) 

185 CuBA Study, p. 45 
186 CuBA Study p. 18 and p. 57 
187 1st FC Study p. 58 
188 CuBA Study p. 18, 36 and 54 
189 measured by willingness-to-pay to avoid it 
190 CuBA Study p. 114-115; p. 131-14 (in particular 142-144) 

67 

  The Dangerous 
Substances and 
Preparations 
Directives   

  The CLP  

  The Carcinogens 
and Mutagens at 
Work Directive  

  The Chemical 

Agents Directive  

  Legislation on 
consumer 
products 
(cosmetics 
(since 2005), 
food contact 
materials 
(2007), 
electrical 
equipment 
(2015), medical 
devices)   
  The Water 
Framework 
Directive 
(priority 

 
 
 
  
                                                 
Benefits 

Estimated 
Benefit Value 
(€) 
for the EU 

What's Included? 

Time period  

Legislation  

Better control and 
management of 
plant protection 
products 191 

EUR 15 – 50 
billion/yr 

Reduced 
environmental and 
pollination impacts: 
  Value of eco 

system services 

Since late 70s 
(legislation on 
water 1975 and 
1979 legislation on 
pesticides)  

EUR 500 
million/yr 

Reduced pesticide 
contamination of 
surface and 
groundwater 
reserves192 

  Agricultural 
value of 
pollination 
services 
provided by 
pollinating 
insects 

Avoided drinking 
water treatment 
costs: 
  Avoided cost of 
removing 
pesticides from 
water treated for 
drinking water 
supply  

Since late 1970s 
(legislation on 
water 1975 and 
1979 legislation on 
pesticides)  

Reduced 
contamination by 
PCBs193 

Cumulative cost 
of EUR 0.4 - 1.9 
billion/yr (EUR 
20 – 90 billion in 
total) 

Avoided clean-up 
costs association 
with PCB use in the 
past: 
  Remediation and 

1971 to 2018 

waste 
management 
costs excluding 
any health and 

substance since 
2001) 
  Pre-REACH 

Regulation (the 
Existing 
Substances 
Regulation) 
1994-2006  
The Plant Protection 
Products Regulation 
(PPPR) 

  The Plant 
Protection 
Products 
Regulation 
(PPPR) 
  The Water 

Framework 
Directive and 
the EQS 
Directive 
  The Drinking 

Water 
Directive  
  Classified under 
the CLP  
  Directive 

96/59/EC on the 
disposal of 
PCBs and 
PCTs (not 
within the 

191 CuBA Study p. 255 
192 CuBA Study p. 215-217 
193 CuBA Stuy p. 267 These clean-up costs are associated with polychlorinated biphenyl (PCBs) use and waste 
management (remediation and waste management costs; but not including any health and environmental impact 
costs) caused by the contamination that has been avoided. 

68 

 
 
                                                 
Benefits 

Estimated 
Benefit Value 
(€) 
for the EU 

What's Included? 

Time period  

Legislation  

environmental 
impact costs 

scope)  
  The POPs 
Regulation 
(2004) 
  Hazardous 
Waste List 

Table 4 Selected monetised environmental and health benefits of reduced hazardous chemical exposures194 

Regarding  enhancement  of  the  internal  market,  competitiveness  and  innovation  objectives, 
these benefits are examined in Sections 5. Effectiveness and 9. EU added value. There have 
been  positive  impacts  of  the  EU  chemicals  legislation  in  terms  of  an  efficiently  functioning 
internal  market.  Benefits  in  terms  of  innovation  and  positive  impact  on  the  EU  industry's 
competitiveness are more complex.  

More  generally  speaking,  the  EU  chemicals  legislation  plays  an  important  role  in  the  shift 
towards  a  more  circular  economy.195  It  also  contributes  directly  to  the  achievement  of  the 
2030 UN Sustainable Development Goals (SDGs196). 

Respondents to the public consultation agreed that the EU chemicals legislation and chemical-
related legislation generate benefits from reducing the exposure of consumers and citizens to 
toxic chemicals, reducing the exposure of workers to toxic chemicals and reducing damage to 
the environment and ecosystems (see Table 5).197  

Group 

Benefits identified by largest proportion of respondents by group 

Top ranked 

Second ranked 

Third ranked 

Group 1 
(citizens) 

Reducing the damage to the 
environment and to eco-
systems (58%) 

Reducing the exposure of 
consumers and citizens in 
general to toxic chemicals 
(54%) 

Reducing the exposure of 
workers to toxic chemicals 
(85%) 

Reducing the damage to the 
environment and to eco-
systems (84%) 

Reducing the exposure of 
workers to toxic chemicals 
(54%) [equal second ranked] 

Reducing the exposure of 
consumers and citizens in 
general to toxic chemicals 
(79%) 

Reducing the exposure of 
consumers and citizens in 
general to toxic chemicals 
(95%) 

Reducing the exposure of 
workers to toxic chemicals 
(92%) 

Reducing the damage to the 
environment and to eco-
systems (89%) 

Group 4 
(NGO/ 

Reducing the exposure of 
workers to toxic chemicals 

Reducing the exposure of 
consumers and citizens in 

Reducing the damage to the 
environment and to eco-

194 CuBA Study 
195 For example, see the Interface between chemical, product and waste legislation communication (COM(2018) 
32 final); 16 January 2018 
196 https://www.un.org/sustainabledevelopment/sustainable-development-goals/ 
197 1st FC Study, Annex V, p.136, question 19 

69 

Group 2 
(industry) 

Group 3 
(public 
authority) 

 
 
 
                                                 
Group 

others) 

Benefits identified by largest proportion of respondents by group 

Top ranked 
(91%) 

Second ranked 
general to toxic chemicals 
(80%) 

Third ranked 
systems (70%) = encouraging 
research and innovation, 
generating jobs and improving 
competitiveness (70%) 

Table 5 Summary of the views of respondents by group to public consultation 

Respondents  to  the  public  consultation  also  indicated  additional  benefits  that  are  generated 
from:  

  encouraging 

research  and 

innovation,  generating  new 

jobs  and 

improving 

competitiveness; 

  stimulating competition and trade within the EU single market; and 
  stimulating international trade between the EU and other countries. 

Results of the SME Panel consultation suggest the impact of the CLP Regulation (and other 
EU  hazard  communication  requirements)  has  been  overall  positive  (increased  access  to 
classification data for substances and more consistent classification, safe use of chemicals by 
workers  and  consumers,  preparedness  for  industrial  accidents,  increased  awareness  of  the 
potential  health  and  environmental  impacts).  The  only  exception  is  “changes  in  packaging 
requirements” where proportion of ‘neutral/no change’ responses was higher compared with 
proportion of responses suggesting positive impact (40% and 35% respectively; 10% negative 
impacts; 15% “Don’t know”).198 

6.1.3  Are costs and benefits proportionate?  

A. 

What's the issue? 

Answering this evaluation question requires the assessment of the framework-wide costs and 
benefits  (environmental,  health,  internal  market,  etc.)  of  the  EU  chemicals  acquis  to 
determine whether the costs are proportionate.  

B. 

What are the findings? 

Conclusions 

The existing data and methodological limitations combined with the scope limitations of the 
Fitness Check (a framework-wide assessment and not a full, in-depth evaluation of each and 
every  one  of  the  more  than  40  pieces  of  legislation  covered)  meant  it  was  not  possible  to 
estimate  of  the  overall  costs  and  benefits  of  the  EU  chemicals  acquis  and  therefore,  to 
determine whether or not costs are proportionate. However, from the partial evidence that was 
available, it appears that both the costs and the benefits generated by EU chemicals legislation 
are significant. 

It is not possible to provide a credible estimate of the cumulative benefits or costs of the EU 
chemicals  acquis.  This,  coupled  with  the  partial  picture  on  the  costs  and  benefits  at  the 

198 1st FC Annex, Annex V p.45-48, question 13, table 2-24 

70 

 
 
 
                                                 
specific legislation level, means it was not possible to arrive at a single cost-benefit ratio and 
that it is impossible to draw any strong conclusions regarding the proportionality.  

It appears from the analysis above that the benefits directly or indirectly generated by the EU 
chemicals legislation are significant while costs to companies and public authorities are also 
significant.199 These views are shared by different stakeholders although the perception of the 
importance  of  the  costs  and  therefore  of  whether  costs  are  proportionate  to  benefits  varies 
amongst different groups and even within the same category.  

Amongst Member States, the UK is the only country to have tried to provide an estimate of 
the costs and benefits of chemicals legislation. The environment ministry quantified the costs 
and benefits of 428 of its regulations affecting UK businesses, just over half of which were 
derived from EU or international legislation. The most positive cost-benefits ratio amongst the 
different  policy  area  clusters  was  for  regulations  on  ‘chemicals  and  genetically  modified 
organisms’ with a ratio of 1:18.9 (with 82% of the costs coming from EU legislation).200 

6.2  Evaluation question: what aspects of the functioning of the framework 

are the most efficient and what are the least efficient?  

This  sections  looks  at  factors  that  affect  the  efficient  functioning  of  the  EU  chemicals 
legislation beyond the sole cost-benefit point of view.  

6.2.1  Reliance  on  the  CLP  Regulation  as  the  basis  for  hazard  classification  and 

labelling  

A. 

What's the issue? 

The  CLP  Regulation  is  the  primary  basis  for  identifying  hazards,  providing  hazard 
classification across  almost all  other pieces of legislation as  well as  labelling and other  risk 
and hazard communication measures. To what extent it is functioning efficiently is assessed 
regarding: 

 
 

its general architecture;  
resources  and  expertise  available  for  putting  forward  harmonised  classification 
dossiers; and 

  communicating chemical hazard and risk information to consumers via labelling. 

B. 

What are the findings? 

Conclusions 

The  overall  architecture  of  the  CLP  Regulation  and  many  aspects  of  its  practical 
implementation  are  operating  efficiently.  The  CLP  Regulation  provides  an  efficient  and 
harmonised approach to the hazard identification and classification of chemicals placed on the 
market  in  the  EU.  However,  its  full  implementation  and  enforcement  appears  to  be 
challenging.  Moreover,  resource  and  expertise  constraints  in  a  number  of  Member  States 
reduce  the  overall  efficiency,  particularly  with  respect  to  harmonised  classification.  Whilst 

199 FC+ Study p. 138 
200  “Emerging  Findings  from  Defra’s  Regulation  Assessment  First  update  covering  2012  Published  February 
2015”, DEFRA  

71 

 
 
                                                 
most of the CLP hazard pictograms are well recognised and understood by consumers, there 
are some inefficiencies in relation to the consumer labelling requirements under the CLP and 
some  overlaps  between  the  CLP,  the  Detergents  Regulation  and  the  Cosmetic  Products 
Regulation.  

The legal architecture of the CLP Regulation based on self-classification by duty holders and 
backed  up  by  harmonised  classification  for  substances  of  concern,  provides  a  clear  and 
consistent  approach  to  identifying,  characterising  and  classifying  hazardous  chemicals.  It 
ensures that the science of chemical hazard assessment and classification is  done  separately 
but then fed into decision-making in the risk assessment and risk management decision steps 
in  other,  downstream  pieces  of  legislation.  Various  stakeholders  were  of  an  opinion  that 
maintaining the CLP system as purely hazard based is important201. It allows classification of 
a wide range of chemicals without creating a disproportionate burden on administration while 
focusing resources of public authorities to the most relevant substances for public health and 
the environment. Furthermore, where no harmonised classification exists, self-classifications 
allows for faster evaluation by companies.  

Harmonised  classifications  rely  on  the  initiative  of  either  companies  or  Member  State 
authorities to create and submit a proposal to ECHA for a harmonised classification which is 
eventually  adopted  by  the  Commission.  Resource  and  expertise  constraints  in  a  number  of 
Member  States  hinder  their  ability  to  make  these  proposals.  The  fact  that  the  workload  in 
developing  harmonised  classification  dossiers  is  shared  unequally  between  Member  State 
Competent  Authorities  is  a  factor  that  negatively  affects  efficiency.202  The  pace  of  whole 
process – from proposal to final agreement - is a factor affecting the overall efficiency given 
that these are the cornerstone of the legislative framework (see Section 5.2.3).203 

There  are  inefficiencies  in  relation  to  consumer  labelling  under  the  CLP  Regulation  as 
highlighted above in terms of proportionality of costs for companies to change some aspects 
of labelling and the effectiveness of the communication.204 The CLP Regulation is amended 
every two years (via the Adaptation to Technical Progress (ATP)) in order to comply with the 
changes made at the UN Global Harmonised System (GHS) level. According to participants 
of  one  of  the  workshops205,  the  EU  approach  of  having  an  18  month  transitional  period  for 
applicability of GHS updates is generally perceived as being sufficient but the constant need 
to  re-label  is  a  cost.  They  also  believed  that  minor  changes  have  no  real  benefits  but  could 
have  significant  negative  impacts  due  to  re-labelling  requirements.  Moreover,  according  to 
these  stakeholders,  SMEs  (downstream  users)  may  have  very  little  time  to  make  labelling 
changes as suppliers upstream provide details late.  

Regarding  detergents’  labelling  information  received  from  AISE  and  other  consultees 
suggests that there are also legislative overlaps between the Detergents Regulation, the CLP 
Regulation  and  the  Cosmetic  Products  Regulation  with  regard  to  the  labelling  of  allergens 
which  creates  unnecessary  regulatory  burden.  The  CLP  Regulation  sets  out  the  hazard 
classification criteria and requirements for respiratory and skin sensitisation and requires the 

201 See 1st FC Study workshop report p. 7, p. 18 
202 FC+ Study workshop report p. 12 
203 1st FC Study p. 62-63 
204 1st FC Study p. 23; see also Special Eurobarometer Survey 456 
205 1st FC Study workshop report p. 14 and 20 

72 

 
 
                                                 
inclusion  of  skin  sensitisers  in  the  list  of  ingredients  when  they  occur  above  certain 
thresholds. The Detergents Regulation also relies on the list of allergens identified under the 
Cosmetic Products Regulation. The Cosmetic Products Regulation does not refer to the CLP 
classification criteria for skin and respiratory sensitizers.206 

6.2.2  Use and access to data  

A. 

What's the issue? 

Data generation was identified as one of the main cost drivers. How data is developed, used, 
and accessed affects the speed at which risk management measures can be implemented. The 
current mechanisms regarding data sharing and access to data are assessed based on:  

 

the  extent  to  which  they  are  flexible  and  facilitate  the  use  of  data  across  different 
pieces of legislation; and  

  what  is  the  contribution  of  the  Good  Laboratory  Practice  (GLP)  Directive  in 

facilitating data sharing.  

B. 

What are the findings? 

Conclusions 

Considerable  efforts  have  gone  into  improving  the  sharing  of  hazard  and  risk  assessment 
related data on chemicals generated under different pieces of legislation and/or held in several 
different databases. However, unnecessary duplication of effort in data generation still occurs 
in some instances due to a lack of data sharing as a result of various related factors including 
confidentiality and intellectual property rights.  

The review of the priority substances list under the Water Framework Directive is an example 
of how taking appropriate action can be delayed even when a potential risk can be identified 
based  on  hazard  data,  for  example.  This  is  because  adequate  exposure  data  are  often  not 
available  to  allow  the  risk  assessment  to  be  completed.  Better  links  with  risk  assessments 
carried out under other legislation might help in such situations, i.e. better access to full risk 
assessments (including relevant exposure data). The Watch List mechanism was introduced a 
few years ago to allow exposure data from surface waters to be generated when otherwise not 
available. Faster feedback of monitoring data obtained under the Water Framework Directive 
to  that  other  legislation  may  also  facilitate  the  prompt  introduction  of  additional  measures 
where necessary.  

The  use  of  the  GLP  Directives  has  played  an  important  and  useful  role  in  standardising 
quality  requirements  for  test  facilities  and  in  ensuring  repeatability  and  consistency  in  data 
generation. 
The GLP Directives are one of the most efficient elements of the EU chemicals legislation207. 
By  standardising  data  quality  requirements,  they  have  helped  to  avoid  double  testing  and 
thereby helped saving time and resources. In addition, the avoidance of double testing helps to 
avoid  unnecessary  animal  tests.  However,  accepting  for  regulatory  purposes  only  GLP 

206 1st FC Study p. 85; see also Case Study 5 in Annex VI and Study supporting the Evaluation of Regulation 
(EC) No 648/2004 (Detergents Regulation) p. 77-79 
207 FC+ Study p. 139 

73 

 
 
                                                 
compliant  data  would  be  counterproductive.  Non–GLP  data  has  a  potential  of  being  useful 
source of information (providing that the data is correctly referenced, reliable and robust) thus 
reducing the need to generate new data, additional costs and delays (see  Section 5.2.1 Data, 
knowledge  and  information  as  well  as  Annex  5  Section  5.2.1  C)  and  Annex  6  Section 
6.2.4).208  

Another aspect that plays a significant role in how efficient is the EU chemicals legislation, is 
access to data and data sharing. Problems are still encountered with data access and sharing 
between regulatory areas because of the lack of a centralised access point (e.g. when useful 
hazard and risk assessment data is sitting in regulatory clusters linked to particular agencies, 
scientific  committees  and/or  legislative  risk  assessment  processes  for  individual  regulations 
and is not readily shared or available to other users), a lack of awareness of what exists in the 
different  databases,  the  lack  of  efforts  in  investigating  whether  data  can  be  used,  and  too 
restrictive access  rights for  use  and re-use  of  data.  It  leads  to  a  certain duplication of  effort 
where  the  nature  of  assessment  made  is  similar  between  different  pieces  of  legislation  and 
therefore  can  generate  extra  costs,  as  well  as  longer-than-necessary  timeframes  and  lead  to 
duplication  of  testing.  This  issue  might  also  have  negative  consequences  in  cases  when 
companies are seeking a derogation, as the timeframes can be relatively short in comparison 
with the time it takes for new and sufficient data to be gathered to prove safe use.209 

Difficulties  encountered  in  updating  the  Water  Framework  Directive’s  list  of  priority 
substances  illustrate  the  potential  efficiency  gains  for  better  data  sharing.  An  additional 
‘Watch List’ mechanism was put in place in 2013210 in order to gather data to inform decision 
making  on  candidates  for  potential  inclusion  in  the  list  of  priority  substances  needs  to  be 
updated.211 This ‘Watch List’ was updated recently. Several substances from the first watch 
list are included in the updated version. This demonstrates how long it can take to gather the 
necessary exposure information. If adequate data is not available by the time that legislation 
(in this case, the priority substances list) needs to be reviewed, it can lead to delays in taking 
appropriate  actions.  Better  links  with  risk  assessments  carried  out  under  other  pieces  of 
legislation  might  help  to  avoid  such  situations,  e.g.  access  to  risk  assessment  (including 
exposure) data, etc. 

During one of the workshops different participants believed that there are cases of duplication 
of  effort  in  assessing  hazards  and  risks  because  data  cannot  be  shared,  due  to  the  above 
mentioned obstacles, leading to inefficiency and inconsistency. Information exchange should 
be  improved  also  between  the  EU  Agencies  and  scientific  committees.  According  to  these 
stakeholders, information gains from improved data sharing would be significant.212  

208 Ibidem 
209 1st FC Study Annex IV p. 75 
210 Directive 2008/105/EC as amended by Directive 2013/39/EU 
211 FC+ Study p. 57 
212 FC+ Study workshop report p. 11, 16 and 23    

74 

 
 
                                                 
6.2.3  Grouping approach vs. substance-by-substance approach  

A. 

What's the issue? 

The EU chemicals legislation is based on a substance-by-substance approach213. Its efficiency 
is assessed based on potential benefits compared to increased use of grouping approach214.  

B. 

What are the findings? 

Conclusions 

The  substance-by-substance  approach  is  efficient  in  identifying  the  hazards  of  a  specific 
substance  and  the  risk  from  the  situation  in  which  it  is  used.  However,  as  highlighted  by 
different stakeholders, there is a need for greater flexibility and a more integrated and holistic 
view in assessing substances as groups.215 The substance-by-substance approach can limit in 
some  cases  the  efficiency  of  the  risk  assessment  process  both  in  terms  of  protecting  human 
health  and  the  environment,  as  well  as  in  terms  of  avoided  costs  to  industry  for  further 
replacement  by  alternatives  e.g.  pre-empting  industry's  investment  in  substances  that  are 
likely  to  be  banned  subsequently.  Approaches  based  on  grouping  chemicals  of  a  similar 
hazard/risk nature together for risk assessment were supported by NGOs and some Member 
State authorities as a way of addressing this challenge. 
The EU chemicals legislation is currently based on the substance-by-substance approach216. It 
is often the most pragmatic approach to conducting risk assessments.217 Much of the hazard 
and  exposure  data  needed  are  held  by  industry  with  assessments  completed  on  single 
substances. Indeed, hazard data on chemicals are usually focussed on single substances rather 
than groups of chemicals and, equally, defined uses of chemical substances are also based on 
individual substances. Moreover, most OECD test guidelines and also alternative in-silico i.e. 
performed  on  computer  or  via  computer  simulation,  approaches  work  on  a  substance-by-
substance basis.  

Although  the  substance-by-substance  approach  is  effective  in  identifying  the  hazards  of  a 
specific substance and the risks from the situation in which it is used, stakeholders from all 
categories have highlighted the need for greater flexibility and a more integrated and holistic 
view  in  assessing  substances  as  groups.218  The  efficiency  of  the  risk  assessment  process  is 
limited by this, both in terms of protecting human health and the environment, as well as in 
terms  of  avoided  costs  to  industry  for  further  replacement  by  alternatives  e.g.  pre-empting 
industry's investment in substances that are likely to be banned subsequently. NGOs and some 
Member  State  authority  stakeholders  supported  the  use  of  chemical  grouping  approaches 

213 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. 
214 A short description is given in Annex 5 Section 2.11 
215 FC+ Study p. 95 
216 It can however be noted that some grouping consideration has been made in certain cases, like for the renewal 
of  approval  of  anticoagulant  rodenticides  (PT14)  as  all  these  substances  share  more  or  less  the  same  hazard 
properties. A similar approach has also been discussed concerning the approval and future renewal of approval 
of antifouling active substances (PT21). 
217 FC+ Study p. 90 and p. 143 
218 FC+ Study p. 95 

75 

 
 
                                                 
whereby chemicals of a similar hazard/risk nature are assessed collectively. However, further 
grouping of chemicals, if envisaged, would need to have been designed and integrated in the 
current  framework  without  leading  to  longer  decision-making  processes  (and  would  not  be 
suitable in all contexts). 
During  one  of  the  workshops219  views  expressed  by  many  different  stakeholders  were  in 
favour  of  increased  use  of  grouping  approach.  According  to  these  stakeholders  grouping 
would provide opportunities for efficiency, as it would prevent industry investing substantial 
resources  and  investments  to  replace  a  substance  that  would  most  likely  be  shortly  banned. 
This  is  especially  the  case  for  SMEs,  for  which  the  processes  can  become  extremely 
burdensome, compared to large companies. According to stakeholders, there is also potential 
for synergies between legislation e.g. grouping done under REACH could be used under other 
pieces of legislation. However, defining what the meaningful group of substances proves to be 
a challenge.  

6.2.4  Organisational efficiency of the EU Agencies and scientific committees   

A. 

What's the issue? 

At  the  EU  level,  risk  assessments  are  conducted  by  a  number  of  different  agencies  and 
scientific  committees  depending  on  the  chemicals  legislation  in  question.  The  organisation 
efficiency is assessed in terms of the speed of different processes and the coherence of their 
outcomes. 

B. 

What are the findings? 

Conclusions 

Currently, difference agencies and committees are involved in providing scientific advice and 
risk  assessments  within  the  chemicals  regulatory  framework.  The  EU  organisational 
efficiency regarding the overall process could be improved and simplified, therefore avoiding 
duplication of procedures and reducing the risk of diverging opinions.  

Currently,  different  Agencies  and  Committees  provide  scientific  advice and  risk  assessment 
without prejudice to the competencies conferred to another one. In most cases, delineation of 
areas  of  competencies  is  clear  e.g.  for  cosmetics  ECHA  is  doing  the  environmental  risk 
assessment  while  the  Scientific  Committee  on  Consumer  Safety  (SCCS)  is  in  charge  of 
assessing  risks  for  human  health.  In  some  other,  there  is  a  potential  overlap  e.g.  substances 
assessed  by  the  Scientific  Committee  for  Occupation  Exposure  Levels  (SCOEL)  under  the 
Occupational  Safety  (OSH)  legislation  and  ECHA  (REACH)220  or  between  the  Scientific 
Committee on Health, Environmental and Emerging Risks (SCHEER) and/or the SCCS and 
ECHA or ECHA and EFSA.  

Annex 8 Section 8.2.2 provides a list of the EU Agencies and Scientific Committees involved 
with hazardous chemical risk assessment (see Figure 18).  

219 FC+ Study workshop report p. 19-21 
220  Please  note  that  from  2019,  the  scientific  evaluation  of  the  relationship  between  the  health  effects  of 
hazardous  chemical  agents  and  the  level  of  occupational  exposure  is  conducted  by  the  Risk  Assessment 
Committee  (RAC)  of  the  European  Chemicals  Agency  (ECHA).  More  information  is  available  at 
https://echa.europa.eu/fr/-/echa-to-provide-recommendations-for-occupational-exposure-limits  

76 

 
 
                                                 
The  SCCS  and  the  SCHEER  have  generally  been  capable  of  addressing  the  Commission’s 
information  needs  related  to  the  assessment  of  health  risks  on  consumer  products  in  a 
satisfactory manner. However, some variations between opinions, depending on the nature of 
the questions addressed and the availability of data and scientific literature on the subject have 
occurred. Since the independent risk assessment agencies have been created, the broader issue 
of how to ensure methodological consistence between them has appeared as prominent, as no 
institutional  mechanism  was  any  longer  available  to  this  aim.  Therefore,  while  the  internal 
coherence of their opinions and that of the opinions of the different scientific committees is 
fully satisfactory, the external coherence - i.e. with the opinions of other EU risk assessment 
bodies  –  presents  some  problematic  aspects.  Applicants  in  particular  have  raised  concerns 
about the misalignment of methodological approaches of the scientific committees with those 
of  the  other  EU  risk  assessment  bodies,  and  expressed  the need  for  more  standardisation  in 
this regard.221   

The Rules of Procedure governing the functioning of the SCCS and the SCHEER explicitly 
recognise the need to ensure good and effective cooperation between these two Committees as 
well  as  with  other  scientific  bodies  of  the  EU.  This  means  identifying  and  solving  at  their 
earliest stage any potential conflicts or divergence of opinions, and the obligation to seek the 
convergence.  The  good  and  effective  cooperation  between  the  SCCS  and  the  SCHEER  is 
ensured via the establishment of the Inter-committee Coordination Group (ICCG) which deals 
with  (amongst  others)  matters  relating  to  harmonisation  of  risk  assessment  and  diverging 
scientific  opinions.  The  SCOEL  has  only  the  obligation  to  seek  to  ensure  cooperation  with 
other  scientific  bodies  and  committees.  Differences  in  the strength  of  the  obligation  to  seek 
the  convergence  is  maybe  a  reason  explaining  why  there  have  been  cases  of  divergence  of 
opinions  between  the  RAC  and  the  SCOEL222  while  such  cases  have  not  (yet)  occurred 
between the RAC and the SCHEER/the SCCS or between the SCHEER and the SCCS.  

The  majority  of  stakeholders  consider  the  division  of  responsibilities  and  resources  for  the 
assessment  of  chemical  risks  to  human  health  and  the  environment  between  ECHA's  Risk 
Assessment Committee (RAC) for industrial chemicals (including biocides, also with ECHA's 
Biocidal  Product  Committee  (BPC)  involvement),  EFSA  for  pesticides  and  food  contact 
materials,  and  the  European  Medical  Agency  (EMA)  for  pharmaceutical  products  to  be 
generally appropriate and efficient.  
During  one  of  the  workshops223  participants  considered  that  merging  risk  assessment 
committees may help to avoid conflicts in responses provided. At the very least there needs to 
be  more  communication  between  risk  assessment  committees  assessing 
the  same 
substances/mixtures.  Different  results  are  not  always  wrong,  but  for  related  topics,  there 
should be consistency in the outcomes.  

221  Second  Intermediate  Evaluation  of  the  functioning  of  the  SANTE  non-food  Scientific  Committees;  final 
report April 2016; p. 79-83 
222 REACH Evaluation SWD(2018) 58 final p. 103. Please note that from 2019, the scientific evaluation of the 
relationship between the health effects of hazardous chemical agents and the level of occupational exposure is 
conducted  by  the  Risk  Assessment  Committee  (RAC)  of  the  European  Chemicals  Agency  (ECHA).  More 
is  available  at  https://echa.europa.eu/fr/-/echa-to-provide-recommendations-for-occupational-
information 
exposure-limits 
223 FC+ Study workshop report p. 13 and 16 

77 

 
 
                                                 
For the sake of improved coherence and efficiency, there may be opportunities to simplify the 
risk  assessment  setup  by  bringing  the  risk  assessment  activities  currently  done  by  some  of 
these scientific committees together under the remit of ECHA or EFSA. It should be however 
noted  that  in  some  cases,  the  assessment  done  by  the  committees  goes  beyond  assessing 
chemical  risks  e.g.  for  toys,  risks  can  be  chemical  but  also  mechanical  and  other  physical 
risks.  

7  COHERENCE 

7.1  Evaluation question: to what extent are the legal acts consistent in how 
they attempt  to  reach the  stated  objectives  and  can  differences  in  the 
hazard identification and risk management of chemicals be justified?  

A. 

What's the issue? 

There  are  some  differences  in  approaches  with  respect  to  hazard/risk  assessment  and  risk 
management processes between some of the different pieces of EU chemicals  legislation. In 
many  instances,  these  differences  reflect  variations  in  legal  scopes  and  objectives  and  thus 
different needs in terms of depth of analysis and evidence required to draw conclusions and 
decide upon any risk management measures that may be needed. Therefore, these differences 
do  not  necessarily  imply  incoherence.  They  illustrate  the  legislator’s  intention  to  provide  a 
framework  that  is  tailored  to  the  specific  circumstances  of  the  substances  used  and/or  the 
likely hazards and exposure.224  

The assessment looks at the consistency in the way different pieces of legislation within the 
scope of this Fitness Check contribute collectively to achieving the primary policy objectives. 
Therefore,  for  the  purposes  of  this  Fitness  Check,  any  differences  identified  were  only 
considered to be a coherence issue where they affected the correct functioning of hazard/risk 
assessment and risk management procedures. 

Where coherence with REACH and other pieces of legislation which are, in principle, outside 
the scope of this Fitness Check225 was considered important for a better understanding of the 
coherence issue, then this was also included in the analysis.  

B. 

What are the findings? 

Conclusions 

Even though the objectives of different pieces of legislation within the scope of this Fitness 
Check are not always identical, the legal acts are generally coherent in how they attempt to 
reach the stated objectives, as illustrated by the use of similar underpinning legal mechanisms 
to do so.  

The focus of the Cosmetic Products Regulation solely on human health aspects was identified 
as  a  legal  gap  by  NGO  stakeholders.  While  it  may  impact  consumer  ability  to  differentiate 

224 FC+ Study p. 106 and onwards 
225  Such  as  for  example  legislation  covering  medicinal  products  for  human  use  (Directives  2001/83/EC)  and 
veterinary medicinal products (Directive 2001/82/EC) regarding PBT/vPvBs assessment 

78 

 
 
                                                 
between  products  in  terms  of  their  environmental  performance  (due  to  the  lack  of  labelling 
requirements on environmental hazards) and, therefore, to make better informed purchases, in 
principle,  any  potential  environmental  risks  arising  from  cosmetic  ingredients  are  addressed  
under REACH, for example, via authorisations or restrictions.  

While  many  of  the  pieces  of  the  legislation  within  the  scope  of  this  Fitness  Check  are 
underpinned  by  all  three  core  policy  objectives  e.g.  the  CLP,  the  Biocidal  Products 
Regulation, the Plant Protection Products Regulation, the Detergents Regulation, a number of 
others are underpinned by only one or two of them, for example (see also Annex 4 Table 1): 

  Human health and the environment: the Seveso III Directive;   
  The internal market and human health: the Cosmetic Products Regulation;  
  The internal market and the environment: the Packaging and Packing Waste Directive; 
  The environment: the Urban Waste Water Directive;  
  Human  health:  the  Drinking  Water  Directive,  the  Occupation  Safety  and  Health 
(OSH) legislation (the Carcinogens and Mutagens at Work, the Chemical Agents and 
the Asbestos Directives); 

  The internal market: the Fertilizers Regulation.  

Moreover, some pieces of legislation have very specific objectives e.g. establish measures for 
the protection of animals used for scientific or educational purposes (the Laboratory Animals 
Directive); provide for a harmonised system for study audit and inspection of laboratories (the 
GLP  Directives);  and  establish  a  voluntary  ecolabel  award  scheme  intended  to  promote 
products with a reduced environmental impact (the Ecolabel Regulation). 

These  variations  in  the  scope  and  nature  of  objectives  do  not,  per  se,  point  to  incoherence. 
They simply illustrate that there is a clear delineation between different priorities depending 
on the scope of the legislation.  
NGOs226  and  several  Member  States227,  however,  highlighted  that  the  Cosmetic  Products 
Regulation  focuses  only  on  human  health  impacts  and  the  internal  market  (while  the 
Detergents  Regulation  covers  all  three  core  objectives  including  protection  of  the 
environment).  As  a  result  risks  assessments  carried  out  for  cosmetic  product  ingredients  do 
not  consider  the  intrinsic  environmental  hazard  properties  and  the  environmental  fate  and 
risks  of  cosmetic  products  and  their  ingredients  across  the  lifecycle  of  the  product.  For 
example  siloxanes,  triclosan,  synthetic  fragrances  and  UV  filters  might  not  constitute  a 
significant  health  risk  for  consumers,  however,  the  cumulated  amounts  of  individual  small 
dosage released into the environment when cosmetic products are washed off can be high and 
thus  constitute  a  risk  for  the  environment.  The  available  evidence  and stakeholder  inputs to 
this  Fitness  Check  were  insufficient  to  identify  the  contributing  factors  and  determine  the 
significance of this gap in practice. It should, however, be noted that the environmental risks 
of substances used in cosmetic products should, in principle be addressed by REACH.228 For 

226 FC+ Study p. 124 
227 1st FC Study Annex II p. 10-11 
228 The Cosmetic Products Regulation, recital 5: “The environmental concerns that substances used in cosmetic 
products  may  raise  are  considered  through  the  application  of  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)  and  establishing  a  European  Chemicals  Agency,  which  enables  the 
assessment of environmental safety in a cross-sectoral manner”. 

79 

 
 
                                                 
example, as of 2020 the placing on the market of siloxane substances  D4 and D5229 will be 
restricted for wash-off cosmetic products.230 REACH already restricts the use of nonylphenol, 
used  as  a  surfactant,  in  cosmetic  products.231  To  date,  9  substances  used  in  cosmetics  have 
been  identified  under  REACH  as  endocrine  disruptors  with  adverse  effects  to  the 
environment.232 However, the lack of labelling requirements for cosmetic products relating to 
environmental hazards impacts the ability of consumers to differentiate between products in 
terms of their environmental performance and make better informed purchases. 

While  the  different  pieces  of  legislation  within  the  scope  of  this  Fitness  Check  try  to  reach 
sometimes  different  objectives,  the  hazard  and  risk  assessment  and  risk  decision  making 
procedures and mechanisms stipulated under the different pieces of EU chemicals legislation, 
are broadly consistent but do vary to some degree. Much of this variation is in line with the 
different scopes, focus, and objectives of the legislation in question and does not represent a 
framework-wide inconsistency. However, some variations pointed to a degree of incoherence.  
Industry233 holds the main responsibility for generating the data necessary for required hazard 
and  risk  assessment  of  chemicals.  In  some  instances,  however,  data  is  also  generated  at 
Member  State  level  (under  the  Water  Framework  Directive  and  the  Marine  Strategy 
Framework  Directive  for  example)  as  well  as  at  the  EU  level  (under  the  Water  Framework 
Directive to set a list of priority substances, under the Industrial Emissions Directive for the 
revision of the Best Available Technique Reference Documents (BREFs) as well as by ECHA 
and the existing Scientific Committees).  

There  are  considerable  variations  in  the  data  requirements  (for  hazard  and  risk  assessment) 
specified  by  the  different  pieces  of  EU  chemicals  legislation.  While  the  lower  data 
requirements come at a cost of potentially missing some hazardous properties and impacting 
human health and  environmental protection as a consequence,  these  differences can, for the 
most  part,  be  explained  and  justified  on  the  grounds  of  differing  likelihood  of  exposures 
(risks), of costs and proportionality and of laboratory animal welfare considerations.  

229 Both substances are high tonnage substances in Europe. A risk to the environment arises from the presence of 
D4 and D5 in certain cosmetic products that are washed off with water after application, because of their hazard 
properties as a PBT and a vPvB substance in the case of D4 and a vPvB substance in the case of D5. Due to 
these properties, they have a potential to accumulate in the environment and cause effects that are unpredictable 
in the long-term and are difficult to reverse. The restriction should apply only to wash-off cosmetic products that, 
under normal condition of use, are removed with water shortly after application because in these circumstances 
D4  and  D5  are  emitted  to  the  aquatic  environment  before  evaporation.  ECHA  has  recently  recommended  the 
adoption of a restriction measure on the use of D4, D5 and D6 substances for leave- on cosmetic products. 
230  Commission  Regulation  (EU)  2018/35  of  10  January  2018  amending  Annex  XVII  to  Regulation  (EC)  No 
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation 
and  Restriction  of  Chemicals 
and 
decamethylcyclopentasiloxane (‘D5’) 
231 point 46(a) of Annex XVII to REACH 
232  Report  from  the  Commission  to  the  European  Parliament  and  the  Council ‘Review  of  Regulation  (EC)  No 
1223/2009 of the European Parliament and of the Council on cosmetic products with regard to substances with 
endocrine-disrupting properties; COM(2018) 739 final p. 3 
233 Employers, manufacturers, importers, exporters, downstream users of a substance or of a mixture, operators 
of an installation or establishment, waste holders, importers or exporters, producers, manufacturers, distributors 
and importer of articles 

regards  octamethylcyclotetrasiloxane 

(REACH) 

(‘D4’) 

as 

80 

 
 
                                                 
Regarding information and testing requirements for CMRs, PBTs/vPvBs and EDs, differences 
in approaches to gathering data have been noted but they do not seem to lead to incoherence 
issues. In general, data requirements need to be systematically updated in order to ensure risk 
assessments  and  risk  management  decisions  are  being  made  based  on  the  latest  scientific 
knowledge and technology. This includes, for example, applying new or revised chemical test 
methods  and  guidelines.  Where  legislation  is  slow  to  adopt  new  or  updated  test  guidelines, 
this can lead to a lack of systematically developed data and therefore affect the ability of risk 
assessment processes to reach robust conclusions.234  

In  terms  of  data  quality  requirements,  consistency  is  supported  by  the  Good  Laboratory 
Practice (GLP) Directives which were introduced to ensure integrity and quality of laboratory 
testing  and  studies.  However,  the  exact  wording  of  the  data  quality  requirements  often 
deviates between regulations (referring either to GLP, to the GLP Directives, or to the OECD 
principles). This can cause confusion for duty holders. However, Member States and industry 
stakeholders indicated that it is clear what types of hazard and risk assessment data need to be 
provided  under  the  different  pieces  of  legislation  and,  in  general,  how  their  quality  and 
completeness  will  be  assessed.  In  addition,  some  outdated  or  inconsistent  provisions  in  the 
GLP Directives have been identified.235 This includes the undefined role of the EU chemicals 
agencies and a lack of clarity on how to treat GLP data from non-OECD/Mutual Acceptance 
of Data (MAD)236 countries, on the exact scope of the definition of chemicals and data quality 
requirement for physical hazard testing under the CLP Regulation.  

The following views were expressed by different groups of stakeholders: 

 

Industry  stakeholders  and  Member  State  stated  that,  in  general,  they  find  the  data 
requirements to be coherent and clear237.  

  Animal  rights  organisations  drew  attention  to  the  ban  on  animal  testing  under  the 
Cosmetic  Products  Regulation  and  the  fact  that  cosmetics  ingredients  can  be  subject  to 
different  data  generation  requirements.  While  for  human  endpoints  all  new  data  for 
cosmetics  ingredients  has  to  be  developed  using  non-animal  test  methods  to  meet  the 
requirements of the Cosmetic Products Regulation, for the cosmetics ingredients that are 
also  used  in  other  products  or  applications,  animal  testing  may  still  be  required  under 
other regulations such as the Plant Protection Products Regulation, the Biocidal Products 
Regulation or REACH.238   

  All  stakeholders  were  of  the  opinion  that  a  greater  harmonisation  of  data  requirements 
would  help  ensure  consistency,  in  particular  for  EDs.239  A  number  of  stakeholders 
highlighted  a  lack  of  coverage  in  data  requirements  for  a  number  of  human  health 
endpoints  (e.g.  sensitisers,  EDs  and  immunotoxic  and  neurotoxic)  in  risk  assessment 
processes across chemicals legislation.  

During  the  public  consultation,  industry  associations  and  companies  as  well  as  civil  society 
representatives  were  of  the  opinion  that  some  aspects  of  the  EU  chemicals  legislation 

234 FC+ Study p. 48-51 
235 1st FC Study Annex III, pp. 69 
236 http://www.oecd.org/env/ehs/mutualacceptanceofdatamad.htm 
237 1st FC Study p. 78 
238 1st FC Study p. 81 
239 1st FC Study p. 77 

81 

 
 
                                                 
framework  are  internally  inconsistent.240  Citizens  and  public  authorities  remained  neutral 
(neither agreed nor disagreed) while a third of public authorities respondents also considered 
the EU chemicals legislation to be internally inconsistent. A more in-depth analysis based on 
further  comments  and  position  papers  received  by  the  Commission  shows,  however,  that 
although  such  issues  were  indeed  identified,  they  most  often  affect  specific  aspects  of 
functioning  of  some  pieces  of  legislation  within  the  scope  of  this  FC  while  not  necessarily 
being relevant to the functioning of the overall framework. Therefore, the opinion that the EU 
chemicals  legislation  is  internally  inconsistent  needs  to  be  nuanced  and  taken  with  caution 
given  also  that  the  share  of  opinions  neither  agreeing  nor  disagreeing  was  significant. 
Moreover,  these  views  are  also  in  contrast  to  the  generally  positive  opinions  expressed  by 
SMEs (SME Panel) on the overall internal coherence of the EU chemicals legislation.  

7.2  Evaluation  question:  what, 

inconsistencies, 
contradictions,  unnecessary  duplication,  overlap  or  missing  links 
leading  to 
between  different  pieces  of 
unintended results?  

legislation?  Are  these 

if  any,  are 

the 

A. 

What’s the issue? 

The coherence of hazard and risk assessment processes was assessed in terms of: 

 
the consistency of hazard identification via the CLP; 
  whether all the relevant hazard classes are covered;  
  whether  legal  criteria  have  been  established  for  identification  of  all  the  relevant 

substances of potential concern;  

  whether  there  are  differences  in  classification  criteria  and  approaches  that  could 

impact the hazard/risk assessment and risk management procedures; 
  how the current legal provisions take into account vulnerable groups; and 
  how  the  current  legal  provisions  take  into  account  risks  posed  by  substances  of 

specific concern.  

Annex  7  provides  more  detailed  assessment  of  the  coherence  of  hazard/risk  assessment  and 
risk  management  procedures  when  dealing  with  specific  substances  such  as  carcinogenic, 
mutagenic  or  toxic  to  reproduction  (CMRs),  persistent,  bio-accumulative,  toxic  and  very 
persistent  and  very  bio-accumulative  substances  (PBTs/vPvBs)  and  endocrine  disrupting 
chemicals (EDs). 

B. 

What are the findings? 

Conclusions 

The CLP Regulation ensures the coherence of chemical hazard assessment and classification 
at the EU level is in line with what is done at the international level (through the UN Global 
Harmonised System (GHS)). It acts as a horizontal reference point for great majority of the 
EU chemicals and chemicals-related legislation, thus ensuring a high degree of consistency of 
chemical  hazard  identification  and  classification.  Regarding  PBTs/vPvBs  and  terrestrial 

240 1st FC Study, Annex V, p. 157; public consultation Question 25. 

82 

 
 
                                                 
toxicity, which are currently not defined as separate hazard classes under the CLP or the GHS, 
the  potential  additional  benefits  of  introducing  these  as  new  hazard  classes  under  the  CLP 
need to be further assessed.  

Regarding  EDs,  the  recently  adopted  Communication  on  endocrine  disruptors  announced 
further  actions  to  ensure  that  citizens  and  the  environment  are  protected  from  exposure  to 
endocrine  disruptors.  Inter  alia,  the  Communication  announces  that  the  Commission  will 
launch a cross-sectoral Fitness Check to assess whether relevant EU legislation on endocrine 
disruptors delivers against this overall objective.241  

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.  

There  is  no  overarching  approach  to  risk  assessment  for  vulnerable  groups.  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 for 
the same vulnerable group (e.g. children) between different pieces of legislation.  

1) 

Hazard identification  

In the EU, chemical hazard identification, assessment and classification is governed primarily 
by  the  CLP  Regulation,  which  sets  the  criteria  for  a  fairly  comprehensive  set  of  hazard 
classes. CLP hazard classification is the basis for chemical hazard classification in most other 
pieces of EU chemicals legislation. Furthermore, since the CLP is aligned to the UN Global 
Harmonised System (GHS), it also helps ensure coherence at international level.  

During  the  public  consultation,  respondents  were  asked  if  the  hazard  classes  in  the  CLP 
Regulation for environmental, physical and human health risks cover all relevant hazards (the 
views  are  summarized  in  Table  6).242  While  there  was  a  clear  ‘yes’  response  from  industry 
associations  and  companies,  the  most  common  reply  from  civil  society  representatives  was 
‘no’.  Public  authorities  responded  mainly  ‘yes’  regarding  human  health  risks.  Regarding 
environmental  risks,  while  the  predominant  reply  was  ‘yes’,  one  third  of  respondents 
disagreed. Responses from citizens were mostly ‘don’t know’.  

Do the hazard classes in the CLP Regulation cover all relevant hazards? 
Predominant replies to the public consultation (question 29) 

Citizens 

Industry 

Publics authorities 

NGOs and other civil 
society organizations 

Environmental risks 

‘I don’t know’ (45%) 

‘Yes’ (82%) 
‘Yes’ (44%) 
‘No’ (34%) 

‘No’ (56%) 

Physical risks 
‘Yes’ (45%) 
‘I don’t know’ (45%) 
‘Yes’ (85%) 

‘Yes’ (71%) 

Human health risks 

‘I don’t know’ (45%) 

‘Yes’ (86%) 

‘Yes’ (63%) 

‘Yes’ (70%) 

‘No’ (53%) 

Table 6 Extent to which respondents agreed that all relevant hazards are covered: replies from the public consultation 

241 COM(2018)734 final 
242 1st FC Study, Annex V, p. 181; public consultation Question 29. 

83 

 
 
 
                                                 
Under  some  pieces  of  legislation  and  for  one  or  two  particular  hazard  classes,  there  are 
elements of hazard identification that are not directly linked to the hazard classes and criteria 
prescribed  by  the  CLP  Regulation.  Examples  include  the  hazard  classes  of  persistent,  bio-
accumulative, toxic (PBT) and very persistent and very bio-accumulative substances (vPvB), 
terrestrial toxicity and endocrine disruptors. 

a) 

PBTs/vPvBs 

Criteria for PBT/vPvB hazard identification are stipulated in REACH Annex XIII. The Plant 
Protection Products Regulation adopted the criteria set out in REACH Annex XIII before its 
revision  in  2011,  whilst  the  Biocidal  Products Regulation  refers  directly  to  REACH  criteria 
and, therefore, remains consistent with latest updates to REACH Annex XIII. This creates a 
potential  for  inconsistent  PBT/vPvB  hazard  determinations  between  the  two  regulations.  To 
date, only one known case of an inconsistent PBT determination has arisen and it concerns the 
substance  acetamiprid.  This  was  not  identified  as  'Persistent'  under  the  Plant  Protection 
Products Regulation and therefore re-approved  for  15 years. However, it was identified and 
classed as 'very persistent' under the Biocidal Products Regulation. Being also ‘toxic, it was  
identified as a candidate for substitution and only approved for 7 years.  

Under  REACH,  the  obligation  to  perform  a  chemical  safety  assessment  applies  only  to 
substances placed on the market in quantities of 10 tonnes or more per year. This means that, 
for  instance,  some  substances  with  PBT/vPvB  properties  may  potentially  be  missed.  If 
harmonised PBT/vPvB criteria were established under the CLP Regulation, it would result in 
the obligation to classify and label substances fulfilling these criteria before placing them on 
the  market  regardless  the  tonnage.  A  proposal  was  made  by  the  EU  in  2009  to  include 
PBT/vPvB hazard classes and criteria in the UN GHS which would then be reflected in CLP. 
However, the UN GHS expert sub-committee concluded that the existing hazard classes i.e. 
hazardous  to  aquatic  environment,  would  capture  any  substances  with  PBT  or  vPvB  hazard 
properties  and  ensure  that  they  are  appropriately  classified  and  labelled.  There  is  also  the 
option to create additional hazard classes for PBT/vPvB directly within the CLP that would 
apply  only  within  the  EU.  However,  the  potential  benefits  of  introducing  this  new  hazard 
class  under  the  CLP  Regulation  needs  to  be  further  assessed.  The  CLP  Regulation  (in  line 
with the UN GHS Environmental hazards ‘building block’) covers only aquatic toxicity. As is 
the  case  for  PBTs/vPvBs,  in  order  for  the  CLP  to  include  criteria  for  terrestrial  toxicity,  it 
would either require amending the UN  GHS or the EU amending the CLP without  changes 
made at the UN GHS level. An attempt to include a terrestrial toxicity hazard class within the 
UN GHS was made in 2006 by Spain but did not receive the support of the relevant UN GHS 
Sub-committee of experts. 

The  fact  that  the  CLP  does  not  contain  harmonised  criteria  for  terrestrial  toxicity  does  not 
mean  that  these  hazards  are  not  identified  and  assessed.  In  principle,  registrants  under 
REACH  are  required  to  consider  whether  or  not  their  substance  might  present  a  risk  to  the 
terrestrial compartment and, if so, to include this in the risk assessment done for substances 
which are placed on the market in quantities exceeding 10 tons per year. In practice, however, 
the lack of a defined hazard class under the CLP combined with the challenge for ECHA of 
checking the veracity of many thousands of registration entries under REACH means there is 
a  potential  for  chemicals  that  are  toxic  to  the  terrestrial  environment  to  be  overlooked. 
Terrestrial toxicity is, however, explicitly and carefully addressed under the Plant Protection 
Products  and  the  Biocidal  Products  Regulations  and  to  some  extent,  by  the  Industrial 

84 

 
 
Emissions  Directive  and  the  Seveso  III  Directive.  Further  evidence  needs  to  be  gathered  to 
determine the extent and significance of these potential gaps in chemical hazard identification 
and classification. 

b) 

EDs 

The legislative measures constituting the EU legal framework regulating chemicals have been 
developed at different points in time and have, in certain cases, different objectives.    

  Under the Plant Protection Products Regulation and the Biocidal Products Regulation, 
the  Commission  set  similar  scientific  criteria  for  the  determination  of  endocrine-
disrupting  properties  in  2017243  and  2018244,  respectively.  A  common  ECHA/EFSA 
guidance  document  drafted  with  support  from  the  Joint  Research  Centre  (JRC)  has 
been established for the identification of endocrine disruptors in the context of these 
Regulations.245  

  Several  other  pieces  of  legislation  contain  provisions  on  how  to  address  endocrine 
disrupors, such as the legislation on chemicals in general (REACH), medical devices 
related legislation and water-related legislation. Requirements vary depending on the 
specific legislation.  

  Food contact materials legislation, the Cosmetic Products Regulation, the Toy Safety 
Directive  and  the  occupational  safety  and  health  (OSH)  legislation  do  not  contain 
specific  provisions  for  endocrine  disruptors.  This  does  not,  however,  prevent  the 
identification  and  assessment  of  substances  with  endocrine  disrupting  properties  on 
case-by-case basis.  

This has resulted in different approaches to endocrine disruptors and has raised questions about 
the  level  of  coherence  of  the  EU  legal  framework  in  terms  of  regulating  endocrine  disruptors.. 
The absence of horizontal criteria for the identification and classification of EDs has also been 
criticized by a number of different stakeholder groups including both NGOs and industry, as 
well  as  national  authorities246  and  was  identified  as  an  area  for  action  in  the  EU's  7th 
Environment Action Programme.247  

The  Commission  considers  that  there  should  be a  coherent  approach to  the  identification  of 
endocrine  disruptors  across  all  relevant  Union  legislation,  based  on  the  broadly  accepted 
definition  of  the  World  Health  Organisation.  The  recently  established  criteria  for  pesticides 
and biocides constitute a first step in that direction but EU legislation in other fields does not 
yet  contain  such  criteria.  However,  since  no  single  regulatory  evaluation  completed  to  date 
has covered all the different vertical and horizontal aspects of addressing endocrine disruptors 

243 Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the 
determination  of  endocrine-disrupting  properties  pursuant  to  Regulation  (EU)  No  528/2012  of  the  European 
Parliament and Council 
244  Commission  Regulation  (EU)  2018/605  of  19  April  2018  amending  Annex  II  to  Regulation  (EC)  No 
1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties. OJ L 101, 
20.4.2018, p. 33–36 
245 Available at https://www.efsa.europa.eu/en/efsajournal/pub/5311  
246 FC+ Study p. 118 
247 http://ec.europa.eu/environment/action-programme/ 

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in EU chemicals legislation, the Commission has committed248 to undertaking a cross-cutting 
assessment  of  the  current  situation.  This  will  assess  whether  relevant  EU  legislation  on 
endocrine  disruptors  delivers  against  the  objectives  to  protect  human  health  and  the 
environment by minimising exposures to these substances. It will also pay particular attention 
to those areas where legislation does not contain specific provisions for endocrine disruptors, 
such as toys, cosmetics and food contact materials. In addition, attention will be paid to the 
consistency  and  intensity  of  actions  to  protect  vulnerable  population  groups  that  are 
particularly sensitive to endocrine disruptors, such as the foetus or adolescents.249  

2) 

Risk management  

a) 

Of the known adverse effects on human health and the environment 

The  majority  of  currently  known  adverse  effects  on  human  health  and  the  environment  are 
covered. However, some inconsistencies occur regarding risk management decisions for EDs, 
PTBs/vPvBs  and  substances  fulfilling  the  classification  criteria  for  Specific  Target  Organ 
Toxicity (STOT250). Regarding neurotoxicity, immunotoxicity and allergens, further evidence 
needs  to  be  gathered  to  determine  the  extent  and  significance  of  these  potential  gaps  in 
chemical risk management.  

i. 

CMRs  

Approaches to the risk management of CMRs are generally coherent, as they are in principle 
prohibited for use in professional and consumer products based on harmonised classifications 
under the CLP Regulation.251 One issue, however, is that of non-threshold CMRs i.e. where a 
no-effect  level  (a  defined  exposure  level  below  which  no  health  impact  can  be  detected  or 
observed) cannot be established. Since, by definition, a non-threshold CMR creates a potential 
risk at any level of exposure, it becomes important to define what the acceptable level of risk 
is. In accordance with the conclusion of the REACH Review, there is currently no consensus 
within the EU on defining the acceptable level of risk. 

ii. 

EDs 

Under  the  Biocidal  and  the  Plant  Protection  Products  Regulations,  EDs  are  given  the  same 
priority as CMRs cat. 1 and are subjected to generic risk considerations, i.e. they should not 
be approved except if negligible risk from exposure or negligible exposure to the substance 
can be demonstrated or if specific derogations apply. Under the Biocidal Products Regulation 
EDs are also automatically banned from use in consumer products on the basis of generic risk 
considerations252. Other legislation, such as that on food contact materials, cosmetics, toys or 

248 ‘Towards a comprehensive European Union framework on endocrine disruptors’ COM(2018) 734 final  
249 COM(2018) 734 final 
250 STOT substances cause specific but non-lethal effects, reversible or irreversible, on organs or organ systems 
in the body following single exposure to a substance. Substances with STOT properties are classified according 
to the CLP Regulation. 
251 1st FC Study p. 81 
252 According to article 58(2) of the Biocidal Products Regulation, “A treated article shall not be placed on the 
market unless all active substances contained in the biocidal products that it was treated with or incorporates are 
included in the list drawn up in accordance with Article 9(2) [Union list of approved active substances], for the 

86 

 
 
                                                 
 
protecting workers at the workplace, does not contain specific provisions for EDs. However, 
substances with ED properties are subject to case-by-case regulatory action on the basis of the 
general requirements of the legislation. 
NGOs and civil society representatives, as well as some Member State authorities253 consider 
the regulatory action taken so far to be inadequate, and have called for stricter and broader EU 
measures. The issue is recognised in the Commission’s recently adopted Communication on 
endocrine disruptors which underlines that the EU strategic approach on EDs for the years to 
come  should  be  based  on  the  application  of  the  precautionary  principle  and  aim  (amongst 
others)  at  minimising  overall  exposure  of  humans  and  the  environment  to  endocrine 
disruptors, paying particular attention to exposures during important periods of development 
of an organism, such as foetal development and puberty.254  

iii. 

PBTs/vPvBs 

Substances  that  are  identified  as  PBTs/vPvBs  can  be  addressed  under  REACH,  the  Plant 
Protection  Products  and  the  Biocidal  Products  Regulations,  and  the  Water  Framework 
Directive. However, there are some inconsistencies regarding how these pieces of legislation:  

  Take into account socio-economic aspects: Under REACH and the Biocidal Products 
Regulation, in  contrast to  the  Plant Protection  Product  Regulation,  a  socio-economic 
analysis, including an analysis of alternatives, is also required as an input to the risk 
management  decision  process  (e.g.  for  authorisations,  restrictions,  etc.).  The  cost-
effectiveness  and  proportionality  of  measures  are  to  be  taken  into  account  under  the 
Water Framework Directive, when taking decisions on measures against the pollution 
of water for the priority substances (Annex X) some of which are PBT/vPvBs.   

  Apply (or do not apply) exclusion criteria: 

o  Comparing the Plant Protection Product Regulation and the Biocidal Products 
Regulation,  the  main  difference  lies  in  the  possibility  to  obtain  a  derogation 
from  the  automatic  ban  for  the  use  of  active  substances  identified  as 
PBTs/vPvBs. Under the Biocidal Products Regulation, their use in products is 
prohibited unless conditions for derogation are met (negligible risk, essential to 
control 
health, 
disproportionate  negative  impact  on  society  when  compared  to  the  risks; 
availability  of  alternatives  is  also  considered).  Under  the  Plant  Protection 
Product  Regulation,  active  substances  identified  as  PBTs/vPvBs  cannot  be 
approved and there is no possibility to obtain a derogation.  

human/animal/environmental 

serious 

danger 

for 

o  Substances used in cosmetics, food contact material, toys and medical devices 
are regulated as regards PBT/vPvB-properties under REACH. Such substances 
can  be  restricted  if  there  is  an  unacceptable  risk  to  the  environment  arising 
from their use in these product types. If a PBT/vPvB-substance is added to the 
authorisation  list  under  REACH,  an  authorisation  to  use  them  can  only  be 

relevant product-type and use, or in Annex I [eligible active substance for simplified authorisation process], and 
any conditions or restrictions specified therein are met.” 
253 Council conclusions on the protection of human health and the environment through the sound management 
of chemicals (15046/16); 6 December 2016 
254 COM(2018) 734   

87 

 
 
                                                                                                                                                         
granted if the socio-economic benefits outweigh their risk and if no alternatives 
are available. 

Some  inconsistencies  were  identified  with  respect  to  the  legislation  covering  medicinal 
products  for  human  use255  and  veterinary  medicinal  products.256  An  assessment  of 
PBTs/vPvBs  properties  of  the  emissions  into  the  environment  from  veterinary  medicinal 
products,  while  not  mandatory,  can  still  be  performed  on  the  basis  of  various  guidance 
documents.257 If risks linked to PBTs/vPvBs properties of a substance are identified, it is not 
clear  what  impact  this  will  have,  if  any,  on  the  authorisation  of  the  veterinary  medicinal 
products that include the substance. For medicinal products for human use, the outcome of the 
environmental  risk  assessment  (e.g.  the  PBTs/vPvBs  assessment)  is  not  considered  in  the 
benefit/risk  analysis,  and  as  such  it  does  not  serve  as  a  basis  for  refusal  of  the  marketing 
authorisation (see Annex 7 Section 7.2.5). The European Commission adopted recently an EU 
strategic  approach  to  pharmaceuticals  in  the  environment.  The  actions  announced  include 
considering  the  findings  of  this  and  recent  REACH  Review  as  regards  links  with  the 
medicinal  products  legislation  in  relation  to  environmental  protection.  This  could,  among 
other  things,  help  to  clarify  the  PBT/vPvB  requirements.  Expanding  environmental 
monitoring  and  knowing  more  about  the  concentrations  of  pharmaceuticals  in  the 
environment would allow environmental risk assessments to be improved and measures to be 
more focused.258  

iv. 

STOTs (Single Target Organ Toxicity substances) 

Under  the  Biocidal  Products  Regulation,  substances  classified  as  STOTs  under  the  CLP 
Regulation are subject to risk management measures based on generic risk considerations (i.e. 
automatically prohibited from use by the general public). This, however, is not the case under 
the  Plant  Protection  Products  Regulation.  There  are  no  equivalent  provisions  under  other 
product specific legislation within the scope of this Fitness Check.  

Regarding  the  occupational  safety  and  health  (OSH)  legislation,  in  principle,  risks  to  the 
safety  and  health  of  workers  arising  from  any  chemical  agent  -  even  those  not  classified  as 
hazardous  under  the  CLP  Regulation  but  which  potentially  pose  an  occupational  health  or 
safety  risk  -  needs  to  be  assessed  by  the  employer.  In  the  case  of  activities  involving  the 
potential exposure to several different hazardous chemical agents, the combined risk of these 
exposures should also be assessed. In both instances, hazards and risks relating to single target 
organ  toxicity  can  be  addressed  where  this  is  identified  as  a  potential  source  of  risk.  These 
risk assessments then constitute the basis for taking preventive risk management measures at 
workplace.   

255 Directives 2001/83/EC (outside the scope of this Fitness Check) 
256 Directive 2001/82/EC (outside the scope of this Fitness Check) 
257  The  current  Committee  for  Medicinal  Products  for  Veterinary  Use  (CVMP)  guideline  on  ‘Environmental 
impact  assessment  for  veterinary  medicinal  products  in  support  of  the  VICH  guidelines  GL6  and  GL38 
(EMEA/CVMP/ERA/418282/2005-Rev.1)  specifies  the  need  for  a  PBT  screening  of  veterinary  medicinal 
products. It refers to EU Technical Guidance Documents for industrial chemicals and biocides for cut-off values 
for each of PBT/vPvB criteria. The guidance also specifies how the PBT characteristics should be assessed by 
making cross reference to the REACH guidance documents. 
258 ‘European Union Strategic approach to Pharmaceuticals in the Environment’ (COM(2019) 128 final)  

88 

 
 
                                                 
v.  Neurotoxicity and immunotoxicity   

NGOs  and  some  Member  State  authorities  pointed  out  a  potential  gap  for  some  "new 
emerging  endpoints"259  e.g.  neurotoxicity,  immunotoxicity.  These  hazard  aspects  present 
health and environmental risks of a similar level of concern to those associated with CMRs, 
PBTs/vPvBs  and  EDs260  but  are  not  always  explicitly  addressed  by  the  EU  framework  of 
chemicals legislation261 e.g. these do not consitute a hazard class under the CLP Regulation.  

In  principle,  neurotoxicity  can  be  addressed  via  the  STOT  hazard  class  under  CLP  and  via 
related pieces of legislation such as REACH, the Biocidal Product Regulation and the Plant 
Protection  Products  Regulation.  However,  in  practice,  expert  stakeholders  indicated  that 
testing  for  neurotoxicity  is  rarely  undertaken  despite  the  availability  of  internationally 
recognised test methods.  

With respect to immunotoxicity, there are currently no internationally recognised test methods 
to  identify  substances  with  this  hazard  characteristic.  It  requires  further  research  and 
development  for  legislation  to  be  able  to  address  the  potential  adverse  effects  on  human 
health. 

vi. 

Allergens   

There is currently no common definition of what constitutes an allergen, i.e. a substance that 
may cause allergic reaction. The CLP Regulation sets out the hazard classification criteria and 
requirements  for  respiratory  and  skin  sensitisation.  The  Cosmetic  Products  Regulation  does 
not  rely  on  the  CLP  classification  criteria  for  the  identification  of  skin  or  respiratory 
sensitizers.  Instead,  it  simply  refers  to  substances  that  can  cause  allergic  reaction.  Such 
substances  are  identified  by  the  Scientific  Committee  on  Consumer  Safety  (SCCS).  While 
there  is  no  specific  list  of  allergens  under  the  Cosmetics  Regulation,  substances  which  can 
cause  allergic  reaction  can  be  restricted,  used  only  under  certain  specific  conditions  or 
banned.  References  to  fragrance  allergens  regulated  by  the  Cosmetics  Regulation  are  also 
included  in  the  Detergents  Regulation262  and  the  Toy  Safety  Directive263.  There  are  no 
specific  legal  provisions  for  allergens  other  than  fragrances  under  these  two  pieces  of 
legislation. 

There are differences in the number of allergens that are regulated under different pieces of 
legislation; this may be appropriate given the different scopes of the legislation, but reasons 
for the differences are not clear.264 

The lack of a harmonised approach to allergens is considered by a number of stakeholders to 
have  negative  implications  for  the  single  market,  competitiveness  and  innovation,  and  for 
ensuring  a  high  level  of  protection  of  human  health.  It  also  impacts  the  communication  of 

259 1st FC Study, Annex V, p. 70; public consultation Question 29. 
260 FC+ Study p. 126 
261 They are explicitly addressed in the Plant Protection Products Data Requirements Regulation. 
262 According to Annex VI, point A of the Detergents Regulation, the allergenic fragrances that appear on the list 
of substances in Annex III of the Cosmetics Regulation, as a result of adaptation to technical progress, shall also 
be listed according to the Detergents Regulation, if added at concentrations exceeding 0,01% by weight. 
263  According  to  Annex  II  Part  III  point  10  of  the  Toy  Safety  Directive  cosmetic  toys  shall  comply  with  the 
compositional and labelling requirements from the Cosmetics Regulation 
264 1st FC Study p. 29 

89 

 
 
                                                 
chemical  hazards  to  consumers  and  their  ability  to  make  informed  purchases.265  Regarding 
toys in particular, a number of stakeholders have noted that allergens are an issue too softly 
regulated  under  the  Toy  Safety  Directive  and  suggested  that  other  allergens  that  are  not 
specifically fragrance allergens should also be regulated.266  

There  are  legislative  overlaps  between  the  Detergents  Regulation  and  the  CLP  Regulation 
with regard to the labelling of allergens. According to AISE267 and other consultees, multiple 
regulations dealing with the labelling of detergents products (the CLP, the Cosmetic Products 
Regulation and the Detergents Regulation) create unnecessary regulatory burden and there is 
a clear opportunity for streamlining labelling requirements.268 269 

b) 

For vulnerable groups  

The  analysis  shows  that  not  all  pieces  of  legislation  within  the  scope  of  this  FC  take  into 
account  risks  to  vulnerable  groups.  Where  such  risks  are  taken  into  consideration,  the 
definition  of  vulnerable  populations  covered  varies  as  there  is  no  horizontally  applicable 
definition of 'vulnerable group'. This means that risks for such groups are addressed on case-
by-case  basis  through  product/risk/sector  specific  legislation  taking  into  consideration 
circumstances,  products  or  environments  of  chemical  exposure  that  could  lead  to  different 
level of protection across the legislation. The following pieces of legislation (non-exhaustive) 
refer to 'vulnerable groups': 

  The Toy Safety Directive (children under 14 years of age); 
  The  Occupation  Safety  and  Health  (OSH)  legislation  (young  workers;  pregnant 

workers); 

  The Plant Protection Products Regulation (pregnant and nursing women, the unborn, 
infants  and  children,  the  elderly  and  workers  and  residents  subject  to  high  pesticide 
exposure over the long term); 

  The  Residues  of  Pesticides  Regulation  (children  and  the  unborn,  vulnerable 

consumers); 

  The Biocidal Products Regulation (pregnant and nursing women, the  unborn, infants 
and children, the elderly and, when subject to high exposure to biocidal products over 
the long term, workers and residents); 

  The  Regulation  on  Food  Additives  (not  mentioning  'vulnerable  groups'  as  such  but 

prohibiting the use of food additives in foods for infants and young children).  

  The  Cosmetic  Products  Regulation  (specific  assessment  for  cosmetic  products 
intended  for  use  on  children  under  the  age  of  three,  and  particular  attention  is  to  be 
paid to the microbiological specifications of cosmetic products intended to be used on 
children under three years of age, on elderly people or on persons with compromised 
immune responses; for derogation to CMR 1A/B ban, particular account to be taken of 
vulnerable  population  groups  by  the  Scientific  Committee  on  Consumer  Safety 
(SCCS) in its evaluation). 

265 1st FC Study p. 82 
266 1st FC Study Annex VI Case Study 8 p. 30-33  
267 AISE is the International Association for Soaps, Detergents and Maintenance Products 
268 1st FC Study p. 85. See also Annex VI Case Study 
269 Study supporting the Evaluation of Regulation (EC) No 648/2004 (Detergents Regulation) p. 71-72  

90 

 
 
                                                 
NGO  stakeholders  indicated  that  clear  definitions  of  children  and  vulnerable  groups  are 
missing in most pieces of the EU chemicals legislation and therefore the current approach is 
not  consistent.  They  also  indicated  that  the  notion  of  'vulnerable  groups'  should  be  broader 
and  include  other  categories  such  as  citizens  with  low  income  and/or  socio-economic 
status.270 Moreover, NGOs highlighted the fact that in some cases risk management measures 
taken under one piece of legislation to protect a vulnerable group are not complemented under 
another  where  the  exposure  could  be  similar.  For  example,  certain  phthalates  are banned  in 
the  use  of  toys  under  REACH  while  they  are  allowed  in  other  products  such  as  carpets, 
textiles or furniture to which children can be exposed to.271 272 

Such differences can be partly explained by differences in legal scope. For example, workers 
safety legislation, by definition, will not apply to children as the child labour is prohibited273 
while the Toy Safety Directive in principle will not cover risks posed to adults. However, it is 
not clear:  

  Why the risk assessment carried out under the Cosmetic Products Regulation take into 
account exposure of children under three years of age to substances classified as CMR 
1A and 1B while the Toy Safety Directive also covers risks to children from CMRs of 
category 2.    

  Why  the  Plant  Protection  Products  Regulation  and  the  Biocidal  Products  Regulation 
take  into  consideration  pregnant  and  nursing  women,  and  the  unborn  while  the 
Pregnant Workers Directive only covers risks to pregnant worker herself but excludes 
consideration of risks to the unborn child.   

The recently adopted Communication ‘Towards a comprehensive European Union framework 
on  endocrine  disruptors’  highlights  the  fact  that  particular  attention  needs  to  be  paid  to  the 
consistency  and  intensity  of  actions  to  protect  vulnerable  population  groups  that  are 
particularly  sensitive  to  endocrine  disruptors,  such  as  the  foetus  or  adolescents.274  In  this 
regard, it can be noted that the current legal provisions do not specifically identify adolescents 
as ‘vulnerable group’ (except under the Young People at Work Directive).  

270 FC+ Study p. 127-128 
271 FC+ Study p. 108 
272 The Commission adopted a Decision to amend the REACH Regulation and restrict the use of the phthalates 
(DEHP,  BBP,  DBP  and  DIBP)  in  consumer  products  on  the  EU  market  that  will  complement  the  existing 
restriction  on  three  other  phthalates  (DINP,  DIDP  and  DNOP)  in  toys  and  childcare  articles  (Commission 
Regulation  (EU)  2018/2005  of  17  December  2018  amending  Annex  XVII  to  Regulation  (EC)  No 
1907/2006  of  the  European  Parliament  and  of  the  Council  concerning  the  Registration,  Evaluation, 
Authorisation  and  Restriction  of  Chemicals  (REACH)  as  regards  bis(2-ethylhexyl)  phthalate  (DEHP), 
dibutyl phthalate (DBP), benzyl butyl phthalate (BBP) and diisobutyl phthalate (DIBP))  
273 The Young People at Work Directive considers children and adolescents to be specific risk groups requiring 
specific measures to be taken with regard to their safety and health. It prohibits child labour (minimum working 
or employment age is not lower than the minimum age at which compulsory schooling as imposed by national 
law  ends  or  15  years  in  any  event).  The  Directive  also  stipulates  that  work  by  adolescents  should  be  strictly 
regulated and protected. According to the Young People at Work Directive ‘child’ shall mean any young person 
of  less  than  15  years  of  age  or  who  is  still  subject  to  compulsory  full-time  schooling  under  national  law; 
‘adolescent’  shall  mean  any  young  person  of  at  least  15  years  of  age  but  less  than  18  years  of  age  who  is  no 
longer  subject  to  compulsory  full-time  schooling  under  national  law;  ‘young  person’  shall  mean  any  person 
under 18 years of age having an employment contract or an employment relationship. 
274 COM(2018) 734 final p. 10 

91 

 
 
                                                 
The main potential implications are during the risk assessment step and with potential knock 
on  consequences  for  the  decisions  on  risk  management  measures.  However,  the  assessment 
done for the purposes of this Fitness Check did not come to a conclusion on the extent of the 
issue and if, in practice, risks to vulnerable populations are not sufficiently well addressed and 
managed because of these legislative gaps and inconsistencies. 

8  RELEVANCE 

8.1  Evaluation question: to what extent do the objectives of the legislative 

framework for chemicals meet the current needs?  

In  this  section  the  relevance  of  the  policy  objectives,  as  well  as  the  risk  management 
approaches of the EU chemicals legislation is assessed. The analysis examines whether there 
are  any  mismatches  between  the  existing  chemicals  policy  objectives  and  the  current 
situation.  It  revisits  the  underlying  drivers  and  assumptions  that  were  considered  when 
designing  and  implementing  the  various  components  of  the  EU  chemicals  acquis  to  assess 
whether  or not  these  remain  valid and  whether  new  drivers  have  emerged  that  have  not  yet 
been accommodated. 

8.1.1  Do  the  original  needs  still  exist  or  are  parts  of  the  chemicals  legislative 

framework now redundant? 

A. 

What's the issue? 

The relevance  of the legislative framework is  evaluated here  in  terms of whether or  not  the 
issues  and  needs  that  triggered  the  introduction  of  the  legislation  still  exist  and  are  still 
relevant. In order to answer this question, it is necessary to link it to the original objectives 
and their alignment with the priorities that have emerged progressively since the adoption of 
the different pieces of EU chemicals legislation. 

B. 

What are the findings? 

Conclusions 

The original needs in terms of protecting human health and the environment from the risks of 
hazardous  chemicals,  of  enhancing  the  functioning  of  the  internal  market  and  of  promoting 
innovation and competitiveness continue to exist. As such, the three core objectives of the EU 
chemicals legislation continue to be relevant. The basic components and approaches applied 
within the EU chemicals acquis to assess and manage the hazards and risks of chemicals also 
remain relevant.   

1) 

Ensuring a high level of protection of human health and the environment 

A  recent  assessment  of  the  cumulative  health  and  environmental  benefits  of  chemicals 
legislation275 identified the continued need for risk assessment and risk management measures 
in order to protect human health and the environment from exposures to hazardous chemicals. 

275 CuBA Study p. 335-346 

92 

 
 
 
                                                 
Taking  into  account  the  growing  volumes  and  complexity  (number,  structure/composition, 
form (e.g. nanomaterials), etc.) of chemicals and supply chains as well as the ever increasing 
number  of  products  and  uses  that  involve  chemicals,  identifying  and  managing  the  risks  of 
hazardous  chemical  exposures  to  humans  and  the  environment  remain  highly  relevant.  A 
significant share of the volume of chemicals produced are classified as hazardous to human 
health (+60%) and/or the environment (+40%). This share has largely remained the same over 
the  last  decade.  Furthermore,  the  imports  of  consumer  goods  and  other  articles  into  the  EU 
have tripled between 2000 and 2015276 creating additional challenges for managing the risks 
associated with the presence of hazardous substances in articles. 

There was broad consensus amongst stakeholders that the basic components and approaches 
of  the  EU  chemicals  acquis  remain  appropriate  and  relevant  in  reaching  environmental  and 
health objectives. It was pointed out a number of times by different stakeholders that the EU 
approach  to  identifying  and  managing  chemical  risks  is  considered  a  benchmark  by  other 
countries and regions in the world.  

2) 

Ensuring 
functioning  of 
competitiveness and innovation of EU industry 

the 

the  Single  Market  and  enhancing 

the 

The  EU  chemicals  acquis  is  still  relevant  regarding  its  basic  goals  of  enhancing  the 
functioning of the internal market and of promoting the competitiveness and innovation of the 
EU chemicals sector and related downstream sectors. Horizontal rules on basic information, 
packaging  and  health  and  environmental  safety  are  prerequisites  for  a  well-functioning  and 
transparent  market,  including  relatively  equal  (reciprocal)  access  to  information,  fair  and 
equal competition and informed consumer choices.  

The  legislation  in  the  scope  of  this  Fitness  Check  has  facilitated  intra-EU  trade  (i.e.  EU 
companies  selling  in  the  EU  single  market  rather  than  only  in  their  home  country  market) 
through  the  harmonisation  of  regulatory  requirements  as  evidenced  by  the  increase  in  the 
share of intra-EU trade of total EU chemicals sales.  

In  terms  of  international  competitiveness,  in  2016  the  EU  chemical  industry  represented 
15.1% of the global market, behind China (39.6%) but ahead of the United States (14.2%)277. 
Although  the  European  share  of  global  sales  has  decreased  (it  was  32.5%  in  1996),  the  EU 
chemicals  industry  remains  internationally  competitive  as  evidenced  by  the  increase  in 
exports  to  non-EU  countries  (around  EUR  100  billion  in  2006  and  EUR  146.2  billion  in 
2016). Moreover, the EU is the largest chemicals exporting market in the world.278   

The EU is frequently cited as a global leader in terms of the development and implementation 
of chemicals policy. Where the EU acts on restricting the use of hazardous chemicals, other 
countries and regions often follow.279 Therefore, the potential for the EU chemicals legislation 
to  act  as  a  driver  of  innovation  in  the  chemicals  sector  and  related  downstream  sectors 
remains relevant, particularly in view of the EU commitment to achieving the UN Sustainable 
Development  Goals  (SDGs)  and  the  United  Nations  Strategic  Approach  to  Chemicals 

276 CuBA Study p. 335-346 
277 Ibidem 
278 CEFIC Facts and Figures Report, CEFIC, 2017 
279 CuBA Study p. 324 

93 

 
 
                                                 
Management  (SAICM)  objective  of  shifting  towards  a  more  sustainable  design  and  use  of 
chemicals. Another illustration of this is in controls on the use of persistent organic pollutants 
(POPs), where international action has frequently followed on from EU action.280    

8.1.2  Have new needs emerged in relation to the health and environmental risk 

management of chemicals? If yes, what are they? 

A. 

What's the issue? 

As  science  continues  to  evolve  and  new  data  become  available  regarding  the  links  between 
exposures  to  hazardous  chemicals  and  the  impacts  on  human  health  and  the  environment,  a 
number  of  concerns  have  emerged  during  the  last  10-20  years  that  are  still  either  only 
partially, or not at all, addressed by the existing framework of EU chemicals legislation. The 
most important of these are discussed below. 

B. 

What are the findings? 

Conclusions 

Some gaps remain within the framework of EU chemicals legislation, namely, how to address 
combination  effects,  how  to  better  understand  and  address  impacts  on  the  environment, 
biodiversity and eco-system resilience, and how to gather knowledge and better manage the 
risks  related  to  the  use  of  hazardous  substances  in  articles.  Concerns  regarding  the  former 
have been acknowledged and steps have been taken to improve the existing methodology and 
risk  assessment  approach.  Gathering  knowledge  about  substances  in  articles  is  particularly 
important as the EU is in the process of shifting towards a more circular economy.  

1) 

Combination effects  

Humans  and  the  environment  may  be  simultaneously  exposed  to  multiple  chemicals  by  a 
single  route  or  multiple  routes,  a  situation  referred  to  as  ‘combined  exposure’.  The  term 
'unintentional  chemical  mixtures'  is  sometimes  used  to  refer  to  the  combined  exposure  to 
multiple chemicals from different sources281. The adverse effects or toxicity of a combination 
of  different  substances  might  be  more  severe  than,  and/or  different  from,  the  individual 
substances involved. It is a cross-cutting issue relevant for a number of topics assessed under 
this Fitness Check (e.g. endocrine disruptors, substances in articles, etc.).  

Effects  from  combined  exposures  are  documented  for  a  limited  selection  of  substances  in 
human  biomonitoring  studies282  283as  well  as  in  animal  studies284.  Several  such  studies 

280 Ibidem 
281 Kienzler, A., Berggren, E., Bessems, J., Bopp, S., Van Der Linden, S. and Worth, A. (2014) Assessment of 
Mixtures - Review of Regulatory Requirements and Guidance. JRC Science and Policy Report EUR 26675 EN 
European Commission, Joint Research Centre, Ispra, Italy 
282  Govarts,  E.et  al.  ‘Combined  Effects  of  Prenatal  Exposures  to  Environmental  Chemicals  on  Birth  Weight’. 
Environmental 
2016 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4881120/ 
283  Danish  Environmental  Protection  Agency,  ‘Exposure  of  children  and  unborn  children  to  selected  chemical 
substances’. 
2017 
chemical 
https://www2.mst.dk/Udgiv/publications/2017/04/978-87-93529-84-7.pdf 

products  No. 

substances 

consumer 

Research 

Health, 

Survey 

Public 

13(5), 

158., 

495, 

vol. 

and 

of 

in 

94 

 
 
                                                 
indicate the occurrence of a growing number of different hazardous chemicals in human blood 
and  body  tissue,  including  in  pregnant  women  and  new-born  infants.  Chemicals  identified 
include  pesticides,  biocides,  pharmaceuticals,  heavy  metals,  plasticisers  and  flame 
retardants285 286. There are, however, still considerable knowledge gaps regarding human and 
environmental  exposures  to  combinations  of  chemicals.  In  part,  this  reflects  insufficient 
attention  to  combination  effects  in  screening  and  human  and  environmental  biomonitoring 
programs.  

Risk assessment processes implemented within the framework of EU chemicals legislation are 
not expressly designed to identify and assess potential human health and environmental risks 
of  different  hazardous  chemicals  acting  in  combination.  Intentional  mixtures,  i.e.  products 
composed  of  a  defined  mixture  of  different  chemical  substances  such  as  glue,  paint  and 
detergents are subject to hazard classification and risk assessment and classification under e.g. 
REACH and the CLP. By contrast, the combination effects of 'unintentional mixtures' formed 
e.g.  during  production  processes,  in  the  products  themselves,  in  the  human  body  or  in  the 
environment are often complex, varying and unknown and therefore currently difficult to risk 
assess.  Moreover,  the  potentially  high  number  of  combinations  of  chemicals  implies  that 
actual physical testing of these is less feasible.  

Estimation of effects of typical combined exposure to a known selection of chemicals in the 
working  environment  for  a  particular  occupational  group  is  generally  easier  to  achieve  and 
very  relevant  due  to  the  high  levels  of  exposure.  However,  workers  are  also  citizens  and 
consumers who can also be exposed to hazardous chemicals through other routes outside of 
the  workplace  e.g.  food,  drinking  water  and  the  external  environment.  While  being  an 
important reality these exposure factors are currently not easy to factor in.   

The  issue  and  risk  assessment  challenge  of  combination  effects  is  recognised  by  the 
Commission287.  Efforts  are  underway  to  better  address  this  issue.  An  example  is  EFSA's 
development of combination effect assessment methods and guidance for pesticides, based on 
Cumulative  Assessment  Groups  (CAGs)288.  This  identifies  compounds  that  exhibit  similar 
toxicological  properties  in  a  specific  organ  or  system,  assuming  that  pesticides  causing  the 
same toxic effects in tissues, organs and physiological systems can produce joint, cumulative 
toxicity,  even  if  they  do  not  have  similar  modes  of  action.  EFSA  published  recently  a 
Guidance  document  describing  harmonised  risk  assessment  methodologies  for  combined 
exposure to multiple chemicals for all relevant areas within EFSA's remit, i.e. human health, 
animal health and ecological areas. 289 

284 Hass, U. et al. (2017). Combined exposure to low doses of pesticides causes decreased birth weights in rats. 
Reproductive Toxicology (corrected proof under http://dx.doi.org/10.1016/j.reprotox.2017.05.004) 
285 Woodruff et. al., Environmental Chemicals in Pregnant Women in the United States: NHANES 2003–2004, 
Environ Health Perspect. 119:878–885 (2011). 
286 The Pollution in Newborns, A benchmark investigation of industrial chemicals, pollutants and pesticides in 
umbilical cord blood, Environmental Working Group, July 14, 2005 https://www.ewg.org/research/body-burden-
pollution-newborns#.WuCm4f5lKUl 
287 COM/2012/0252 final 
288 https://www.efsa.europa.eu/en/press/news/130712 
289  “Guidance on harmonized methodologies for human health, animal health and ecological risk assessment of 
combined 
at 
https://www.efsa.europa.eu/en/efsajournal/pub/5634. In addition, EFSA published a “Statement on genotoxicity 

(EFSA,  March 

chemicals.” 

Available 

exposure 

multiple 

2019) 

to 

95 

 
 
                                                                                                                                                         
 
2) 

Impacts on environment, biodiversity and eco-system resilience 

Impacts  of  hazardous  chemicals  on  biodiversity  and  eco-systems  contribute,  together  with 
other stressors, to the reduction of 'eco-system resilience' i.e. the ability to resist damage and 
to recover. This can lead to rapid declines in animal populations (see Annex 5 Sections 5.1.1 
B) and 5.1.1 C)) and, ultimately, to extinctions. Other consequences include sub-lethal effects 
such as reductions of fertility, impaired feeding patterns and lost ability of orientation which, 
over  time,  lead  to  the  weakening  of  populations.  Publications  found  that  exposures  to 
hazardous chemicals, in particular pesticides, in combination with other factors, are leading to 
significant reduction of insect populations290 with effects in the food chain, in particular for 
bird populations, many of which are in decline in the EU.   

Although  the  potential  of  some  hazardous  chemicals  to  cause  harm  is  recognised  and 
considered  in  the  regulatory  context,  their  role  in  the  complex  interaction  with  other 
environmental stressors and the actual contribution – compared to the other stressors – to the 
effects seen in the environment is less well understood. Current standard test and assessment 
methods  typically  do  not  focus  on  these  long  term,  large  scale  and  complex  environmental 
effects. 

3) 

Substances in articles and Circular Economy aspects 

Hazardous  substances  are  included  in  articles  and  may  be  released  at  any  lifecycle  stage, 
resulting in exposures and potential risks for humans and for the environment. This is true for 
articles  newly  produced  or  already  placed  on  the  market.  Access  to  information  on  the 
chemical content of articles is, therefore, important for risk management across all stages of 
the product lifecycle, including its end-of-life and for potential recovery into secondary raw 
material cycles, as well as for appropriate labelling and informed consumer choices.  

There is a general lack of information about the presence of hazardous substances in articles 
e.g. the possible presence of chemicals of concern such as flame retardants in plastics used in 
construction,  automotive,  aviation,  furniture  and  electronics  applications.291  This  lack  of 
information renders it difficult for:  

  Regulators  to  carry  out  overall risks  assessment,  determine  the  scale  of risks,  and to 

choose regulatory risk management measures. 

  Economic operators and consumers to make well-informed purchasing decision about 

articles containing or not hazardous substances. 

  Waste  treatment  operators  to  separate  and  treat  end-of-life  articles  in  a  manner  that 

prevents contamination of recycled materials. 

Moreover, new chemicals are continuously placed on the market whilst others are forbidden 
or gradually phased out when it is discovered that they pose a risk. This means that products 
legally  produced  today  may  contain  a  substance  that  later  on  may  be  banned.  When  the 
product becomes waste and is then recovered, the banned substance may still be contained in 
the recovered material as so-called legacy substance. For example, certain brominated flame 

of 

chemical 

assessment 
https://www.efsa.europa.eu/en/efsajournal/pub/5519  
290 CuBA Study p. 243-274 
291 The EU Strategy for Plastics (COM(2018) 28 final) 

mixtures.” 

(EFSA, 

January 

2019) 

available 

at 

96 

 
 
                                                                                                                                                         
retardants  that  are  persistent,  bio-accumulative  and  toxic  have  been  reportedly  found  in 
recycled plastic products including toys and kitchen utensils.  

Furthermore,  an  assessment  conducted  by  ECHA  across  27  Member  States  and  reported  in 
2018292  found  a  considerable  number  of  non-compliance  cases  with  existing  rules  on 
hazardous  chemical  restrictions  or  bans  in  articles.  The  non-compliance  rate  was  higher  for 
articles 'of unknown origin' and for articles originating from China.  

An  existing  horizontal  approach  to  information  on  chemicals  content  in  articles  is  based  on 
REACH  requirements  for  the  notification  and  provision  of  information  on  the  content  of 
substances of very high concern (SVHCs) to professional users and consumers (Article 7 and 
33  respectively).  Provisions  also  exist  in  the  Biocidal  Products  Regulation  concerning  the 
labelling  of  articles  treated  with  biocides.  Communication  of  information  to  consumers 
(article 58(3), (4), (5) and (6) of the Biocidal Products Regulation) is done in a similar way to 
REACH. In parallel to these legal requirements, there are a range of voluntary business-driven 
initiatives to manage and make available information on chemicals in articles mainly aimed at 
supply  chain  communication.  However,  the  coverage  of  article  types  and  businesses  is  still 
limited.  

Civil organisations and NGOs, as well as some Member State authorities have identified the 
lack of chemical safety criteria in the General Product Safety Directive (GPSD) and consider 
this  to  be  a  major  gap  within  the  horizontal  legislative  framework  for  consumer  products. 
Examples  of  categories  of  articles  which  are  not  covered  by  any  specific  EU  product 
legislation  addressing  chemical  exposure  include  materials  in  contact  with  drinking  water, 
construction  materials/products,  furniture,  clothing  and  textiles293,  child  care  articles  and 
sports and playground equipment and surfaces.294  

The  GPSD,  however,  was  not  designed  to  set  out  specific  chemical  safety  criteria  but  to 
manage  the  risks  of  products  in  general.  According  to  the  GPSD,  all  articles  ('consumer 
products') placed on the market, must be safe and comply with its provisions. In areas where 
no  EU  legislation  or  standards  exist,  the  compliance  with  the  GPSD  safety  requirement  is 
determined  according  to  other  reference  points  such  as  national  standards,  Commission 
recommendations,  codes  of  practice,  etc.  When  measures  are  taken  against  unsafe  products 
found  on  the  market,  national  market  surveillance  authorities  notify  this  to  other  Member 
States and the Commission through the Rapid Alert System for dangerous non-food products 
(RAPEX). 

As the EU shifts towards a more circular economy, one of the commitments of the Circular 
Economy  Action  Plan295  in  2015  was  to  develop  a  strategic  approach  on  chemicals  in  the 

292 FORUM REF-4 PROJECT REPORT, Harmonised Enforcement Project on Restrictions, European Chemicals 
Agency,  February  2018  https://echa.europa.eu/documents/10162/13577/ref_4_report_en.pdf/b53f5cd9-64a4-
c120-1953-e9e176b9c282  
293 Under REACH, 33 CMR substances (and substance groups) have been restricted for use in clothing, textiles 
and  footwear  via  Commission  Regulation  (EU)  2018/1513  of  10  October  2018  amending  Annex  XVII  to 
Regulation (EC) No 1907/2006. 
294 FC+ Study p. 120-122 
295 Closing the loop - An EU action plan for the Circular Economy, Brussels, 2.12.2015; COM(2015) 614 final 
http://eur-lex.europa.eu/resource.html?uri=cellar:8a8ef5e8-99a0-11e5-b3b7-
01aa75ed71a1.0012.02/DOC_1&format=PDF 

97 

 
 
                                                 
circular  economy.  It  covers  assessing  and  addressing  the  health  and  environmental  risk 
aspects associated with information about substances in articles as the recycling and re-use of 
products and materials in general will become increasingly relevant.  

The  scale  of  the  problem  is  significant.  The  Commission  has  recognised  the  issue  and 
proposed  a  number  of  priority  areas  and  options  for  action  as  a  part  of  its  work  on  the 
interface between chemicals, waste and product policies. This includes accelerating work to 
identify possible ways to make chemicals easier to trace in recycled streams.296 In relation to 
this,  the  recently  revised  Waste  Framework  Directive  provides  the  legal  basis  for  the 
establishment of an ECHA-managed database on the presence of SVHCs in consumer goods 
('articles')  with  access  provided  to  waste  treatment  operators  as  well  as  consumers  upon 
request.297  

The  inclusion  of  circular  economy  considerations  into  chemicals  risk  management  will 
require a transformation of the life cycle stages and timescales considered in risk assessment, 
with assessors needing to consider not only the ‘first’ life of a product, but also the ‘second’, 
‘third’ and all potential future lives, moving to a new form of life-cycle assessment. In order 
to  adapt  hazard  and  exposure  scenario  assessments  accordingly,  more  information  and  data 
will  need  to  be  gathered  on  substance  uses  and  releases  from  articles,  which  are  currently 
often not available. 298 

8.2  Evaluation  question:  to  what  extent  does  the  current  legislative 
framework  for  chemicals  take  into  account  health,  environmental, 
social  and  economic  consequences  that  are  relevant  to  citizens  and 
stakeholders? 

The ability of the EU chemicals  acquis to remain relevant and fit for purpose is dependent, 
among other things, on the ability of EU and Member State policy makers to take into account 
and address the concerns and issues raised by different stakeholders in a balanced, open and 
well-justified  manner.  A  number  of  requirements  and  processes  for  ensuring  proper 
stakeholder  engagement  are  built  into  both  the  overall  EU  regulatory  system,  such  as  the 
Better  Regulation  programme,  as  well  as  into  individual  pieces  of  legislation.  This  includes 
active  communication  to  citizens  and  other  stakeholders  about  the  hazards  and  risks  of 
chemicals. This section assesses the adequacy and continuous relevance of these processes.  

8.2.1  Taking into account the concerns of citizens and other stakeholders 

A. 

What's the issue? 

Public  and  stakeholder  consultation  is  integral  to  well-informed  decision-making  and  to 
improving the quality of law-making. It is also vital that citizens and other stakeholders feel 
they can make their concerns known and that these are heard and addressed. 

296 Interface between chemical, product and waste legislation (COM(2018) 32 final) 
297 Directive (EU) 2018/851 of the European Parliament and of the Council of 30 May 2018 amending Directive 
2008/98/EC on waste; Recital 38 and Article 1 and 9(2) 
298 FC+ Study p. 129 

98 

 
 
                                                 
B. 

What are the findings? 

Conclusions 

The  current  EU  chemicals  legislation  includes  numerous  mechanisms  for  ensuring  that 
concerns of citizens and other stakeholder groups are known and addressed including health, 
environmental, social and economic consequences. By and large, stakeholders appreciate the 
level of consultation  that is  undertaken although some stakeholders, notably  NGOs but  also 
industry, feel that their voice, whilst heard, is not always addressed. 

In the design, development, implementation and update of EU chemicals legislation, there are 
multiple opportunities for different stakeholders to have access to the hazard/risk assessment 
information and considerations and to express their views. It can be done through both formal 
and  informal  processes.  This  includes  online  public  consultations,  workshops,  targeted 
stakeholder interview processes, etc., during the life of a piece of legislation, starting from ex-
ante impact assessment for newly proposed (or to be revised) legislation to ex-post evaluation 
of  existing  legislation  as  it  was  done  for  this  Fitness  Check  (regarding  the  stakeholder 
consultation  activites  carried  out  for  the  purposes  of  this  Fitness  Check  please  see  Section 
4.1.2  and  Annex  2).  The  Commission  also  conducts  regular  citizen  surveys  via  its 
Eurobarometer service e.g. the two recent surveys on citizen views of chemical safety299 and 
on  the  environment  which  included  a  focus  on  the  impact  of  chemicals300.  Many  of  these 
elements are managed as an integral part of the Commission's Better Regulation programme. 

Stakeholders  can  also  provide  expert  input  to  the  policy  making  and  implementation 
processes  through  the  various  expert  groups  created  by  the  Commission.  For  example, 
CARACAL301  is  an  expert  group  which  advises  the  European  Commission  and  ECHA  on 
questions  related  to  REACH  and  the  CLP  Regulations.  CARACAL  is  composed  of 
representatives  of  Member  States  competent  authorities  for  REACH  and  the  CLP, 
representatives  from  competent  authorities  of  European  Economic  Area  and  European  Free 
Trade  Association  countries  as  well  as  a  number  of  observers  from  non-EU  countries, 
international organisations and stakeholders. In a similar way, expert groups were established 
to  ensure  cooperation  between  Member  States,  stakeholders  and  the  Commission  and  to 
ensure consistent implementation of the legislation within the EU for toys safety, detergents, 
cosmetics and medical devices, fertilizers and others.  

These  different  processes  help  ensure  that  socio-economic  consequences  of  relevance  to 
different stakeholder groups such as impacts on businesses, especially SMEs, and consumers, 
increases in administrative costs, human health and environmental impacts, etc., are properly 
taken into  account. It also helps to  identify and avoid potential  unintended consequences of 
changes in legislative requirements e.g. chemicals legislation can have an impact on recycling 
activities when content/concentration limits are set for a specific substance.  

The  following  aspects  were  highlighted  by  different  stakeholder  groups  related  to  their 
participation in the decision making process302:  

299 https://data.europa.eu/euodp/data/dataset/S2111_86_3_456_ENG 
300 https://data.europa.eu/euodp/data/dataset/S2156_88_1_468_ENG 
301 http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetail&groupID=2385 
302 For more details please refer to the 1st FC Study, Annex IV p. 29-33 and p. 88-89 

99 

 
 
                                                 
  NGO  stakeholders  expressed  some  frustration  about  the  lack  of  transparency  and 
ability  to  provide  input  to  the  risk  assessment  processes  conducted  by  the  Scientific 
Committee  on  Health,  Environmental  and  Emerging  Risks  (SCHEER)  and  the 
Scientific Committee on Occupational Exposure Limits (SCOEL). 
Industry stakeholders reported a lack of consultation on opinions under the Scientific 
Committee on Consumer Safety (SCCS). They claim that the SCCS allows little to no 
stakeholder participation in practice while in principle the committee procedure allows 
to  call  upon  stakeholders  to  provide  further  scientific  information  as  and  when 
required, and the potential for public consultation is available.  

 

  The  working  groups  under  EFSA  that  formulate  the  opinions  for  approval  of  active 
substances have been criticised by stakeholders for their lack of stakeholder input. The 
main mechanisms for such input are there but they are not considered to be sufficient. 
It  has  been  suggested  by  one  stakeholder  that  although  the  procedures  for  scientific 
opinions  are  appropriate,  because  the  process  is  not  always  transparent,  it  is  not 
entirely clear to either industry or civil society how a decision is made.   

  Member State authorities have highlighted the lack of representation of Member States 
in  the  working  groups  on  chemicals  and  particularly  in  the  SCOEL.  However,  the 
SCOEL more generally has been put forward as providing a good level of stakeholder 
participation  in  their  processes  even  though  this  is  not  outlined  in  their  rules  of 
procedure in contrast to the other committees. More generally, authorities have noted 
that  participation  of  stakeholders  (excluding  Member  States)  is  dependent  on  the 
committee concerned.   

Respondents to the public consultation were asked to identify if they thought that all relevant 
chemical  hazard  and  risk  assessment/management  considerations  are  taken  into  account, 
including combined effects of chemicals, impacts on vulnerable groups, impacts on jobs and 
competitiveness, etc. ‘No’ was the most common reply from all groups of stakeholders. Based 
on the detailed comments received, the main topics considered to be insufficiently taken into 
account  are  combination  effects  (all  stakeholder  groups),  jobs,  competitiveness  and  cost-
benefit  and  socio-economic  analysis  (industry  stakeholders)  and  new  science  and  data 
(citizens, industry and NGOs).303  
The recent OECD Regulatory Policy Outlook 2018 report304 ranked the Commission as one of 
the  top  performers  amongst  OECD  countries  and  institutions  in  terms  of  stakeholder 
engagement  for  both  primary  and  secondary  law  and  for  impact  assessment  and  ex-post 
evaluation.  The  OECD  used  a  number  of  parameters  that  included  oversight  and  quality 
control,  public  access  to  information  on  planned  consultations,  comment  received  by 
stakeholders during the consultation phase or replies to consultation comments.  

303 1st FC Study, Annex V p. 102-108; public consultation Question 15 
304 
https://www.oecd-ilibrary.org/docserver/9789264303072-
en.pdf?expires=1540545486&id=id&accname=oid031827&checksum=9B7DDDF0A0B3253CC5F719B9DF7C
6EB3  

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8.3  Evaluation  question:  to  what  extent  are  the  current  procedures 
transparent  and  robust  enough  to  enable  decisions  related  to  hazard 
identification,  risk  assessment  and  risk  management  to  be  relevant 
and evidence-based? 

Key principles and objectives of the EU's Better Regulation programme include ensuring that 
decision-making  is  open  and  transparent,  that  citizens  and  stakeholders  can  contribute 
throughout the policy and law-making process and that EU actions are based on evidence and 
on a clear understanding of the policy/regulatory impacts.  

8.3.1  Transparency of procedures  

A. 

What's the issue? 

The  ability  of  different  stakeholders,  including  industry,  NGOs,  academics,  experts  and 
citizens  to  gain  access  to  the  data  used  for,  and  to  be  part  of,  the  decision-making  process 
especially during key stages of hazard and risk assessment/management processes is essential 
for the effective chemicals risk management.  

B. 

What are the findings? 

Conclusions 

The  general  decision  making  process  in  the  chemicals  policy  area  has  been  continuously 
improved  in  line  with  the  Commission's  Better  Regulation  principles.  Overall,  the  different 
stakeholders  groups  are  satisfied  with  the  ability  to  gain  access  to  the  hazard/risk 
assessment/management  decision-making  process  although  both 
industry  and  NGOs 
expressed  a  degree  of  frustration  in  some  particular  cases  e.g.  access  to  certain  steps  of  the 
harmonised classification process and to the studies and data used as a basis for certain risk 
assessment/management  decisions  by  the  different  risk  assessment  agencies  and  scientific 
committees. 

Respondents  to  the  public  consultation  were  asked  to  indicate  their  level  of  satisfaction 
regarding  the  transparency  of  procedures  (the  overall  EU  legislative  framework).  Public 
authorities  together  with  industry  stakeholders  were  the  most  satisfied  while  NGOs  and 
others, and citizens assigned lower scores indicating lower level of satisfaction.305  
During one of the workshops, participants expressed the following views306: 

 

In general, the participants agreed that transparency has increased with, for example, 
the publication of meeting documents, draft opinions and opinions of committees etc. 
Nevertheless,  this  transparency  may  be  more  evident  to  those  people  who  regularly 
deal  with  the  assessment  procedures  (e.g.  experts)  than  to  those  who  do  not  (SMEs, 
downstream  users, trade  unions).  As  regards  SME  participation  in  the  processes,  the 
issue of language (many of the hazard/risk assessment processes are conducted soley 
or primarily in english) being a barrier to participation was raised, as was the issue of a 

305 1st FC Study, Annex V p. 108-112; public consultation Question 16 
306 1st FC Study workshop report p. 10-12 

101 

 
 
                                                 
lack of resources, which is also relevant to NGOs and their ability to be represented in 
different fora. 

  Overall,  expert  groups  were  perceived  as  a  good  model  for  ensuring  transparency, 
because  stakeholders  can  participate  as  observers  or  experts.  There  were  some 
concerns  about  the  transparency  of  scientific  committee  selection  processes  (e.g. 
decisions on nominations and potential conflicts of interest).  

Regarding in particular the CLP related processes: 

  All  stakeholder  groups  (industry,  NGOs,  government  authorities,  other  civil  society 
representatives,  etc.)  consider  the  Harmonised  Classification  and  Labelling  (CLH) 
process307 to be well understood.  

  They  also  stated  that  the  process  in  place  up  to  the  point  when  ECHA's  Risk 
Assessment Committee (RAC) opinion (pre-regulatory phase) is issued is, in principle, 
transparent.  However,  the  lack  of  communication  between  the  companies  providing 
data  for  the  CLH  dossier  and  the  Member  State  authorities  can  result  in  a  lack  of 
clarity as to what information was taken into account during the decision making. This 
is exacerbated by the fact that the raw data/full studies underlying an opinion or CLH 
decision are not published.  

 

  ECHA's efforts to further improve transparency on what stage a particular substance is 
at within the various regulatory processes have been well received by stakeholders.  
In  contrast  to  the  pre-regulatory  and  RAC  processes,  some  stakeholders,  notably 
industry, expressed concerns about transparency and stakeholder involvement during 
the risk management decision making phase i.e. after the risk assessment opinion has 
been  issued  by  RAC.  It  should  be  noted,  however,  that  this  lack  of  transparency 
results, in part, from industry submitting other (e.g. socio-economic) information into 
the process and therefore, to some extent, unnecessery duplication of efforts.  
In addition, long time periods for arriving at the final risk management decision can 
lead  to  questions  over  the  objectivity  and  predictability  of  the  process  from  both 
industry and NGOs. 

 

Despite considerable progress, transparency of risk analysis remains an important issue under 
the General Food Law (GFL)308  as  recognised in its 2018 ex-post evaluation309. In terms of 
perception as regards risk assessment in the context of authorisation dossiers, EFSA is bound 
by strict confidentiality rules and by the legal requirement to primarily base its assessment on 
industry  studies,  laid  down  in  the  GFL  Regulation  and  in  the  multiple  authorisation 
procedures  in  specific  EU  food  legislation  e.g.  the  Plastics  Food  Contact  Materials 
Regulation. These  elements lead civil  society  to perceive a certain lack of transparency and 
independence  of  EFSA  with  impacts  on  the  trust  in  EFSA's  scientific  work  by  the  general 
public.  Risk  communication  has  not  always  been  effective  with  consequent  impacts  on 
consumers' trust and acceptance of risk management decisions.  

307  ECHA  receives  as  a  CLH  proposal  from  a  Member  State  and  publishes  the  proposal  (dossier)  for  public 
consultation. Consultation responses are then taken into account by the RAC when forming their opinion on the 
proposal. This opinion is then sent to the commission for decision making.  
308 EU 178/2002 General Food Law 
309 SWD(2018) 37 final   

102 

 
 
                                                 
Member  States  also  expressed  some  concerns  related  to  the  transparency  of  the  processes 
under the Plant Protection Products Regulation. In  particular, they noted that there can  be a 
lack of communication between EFSA and the Member State Rapporteur when concluding on 
the  harmonised  classification  of  an  active  substance.  In  this  regard,  in  April  2018  the 
Commission made a proposal which aims to improve the disclosure of data contained in the 
dossiers  submitted  by  industry  for  active  ingredient  approval  under  the  Plant  Protection 
Products Regulation and ensuring the involvement of EFSA in pre-submission meetings310. 

8.3.2  Robustness of procedures  

A. 

What's the issue? 

The  robustness  of  chemical  risk  assessment  and  decision  making  is  dependent  on  the 
relevance  and  reliability  of  the  underlying  science  and  data.  The  necessary  requirements, 
procedures, processes and capabilities need to be enshrined and applied within the framework 
of EU chemicals legislation to ensure decisions are based on relevant and reliable science and 
data. 

B. 

What are the findings? 

Conclusions 

Numerous  requirements,  mechanisms  and  safeguards  have  been  incorporated  into  the 
framework of EU chemicals legislation to ensure that risk management decisions are based on 
sound science and evidence. Their application is considered to be generally effective but more 
can be done to ensure all relevant evidence (e.g. peer-reviewed academic studies) is available 
for the assessment and decision-making processes. 

The  EU  legal  framework  on  chemicals  is  generally  well  designed  to  make  science  and 
evidence based decisions. In particular311:  

  The Cosmetic, Detergents, Biocidal Products, Plant Protection Products and Fertilizers 
Regulations  are  considered  to  take  adequate  account  of  scientific  and  technical 
developments. No significant issues have been identified in terms of the existence of 
mechanisms to adapt these pieces of legislation to new developments.   

  Cosmetic,  detergents,  biocidal  and  plant  protection  products  legislation  put  in  place 
appropriate  assessments  based  on  state  of  the  art  methods.  Moreover,  even  though 
there  is  no  legally  binding  frequency  for  undertaking  a  review  of  risk  assessment 
requirements and other procedures under these pieces of legislation, mechanisms are 
in  place  for  these  purposes  (through  updating  Annexes  in  the  case  of  cosmetics  and 
detergents  or  through  updating  Annexes,  Implementing  Regulations,  or  guidance 
documents used for the approval of active substances for biocides and pesticides). 
  The overall approach of data generation under the CLP (consideration of all available 
data  and  possibility  to  use  alternative  methods  to  fill  data  gaps)  is  considered  to  be 
adequate and reducing the level of uncertainty.   

310 http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1523604766591&uri=COM:2018:179:FIN 
311 1st FC Study p. 74-75 

103 

 
 
                                                 
  The Fertilizers Regulation (currently under revision) lacks specific data requirements 
and the risk assessment process is not deemed sufficient to ensure that risk assessment 
is based on the latest state of the art methods.  

  The  responsible  agency  and  scientific  bodies  take  into  account  the  latest  scientific 
finding  for  classification,  risk  assessment  and  risk  management  decision  making 
purposes.  

The  robustness  of  these  procedures  has  also  led  to  progressive  improvement  of  the  state  of 
knowledge and to closing knowledge gaps.  

As explained in Section 5. Effectiveness (as well as in Annex 5 Section 5.2.1 C)) more can be 
done to ensure all relevant evidence (e.g. peer-reviewed academic studies) is available for the 
assessment  and  decision-making  processes  and  that  available  data  in  key  databases  held  by 
ECHA and EFSA is made available and re-used instead of requesting new, duplicative data to 
be generated. 

9  EU VALUE ADDED 

9.1.1  Evaluation  question:  what  is  the  added  value  of  regulating  the  risk 
management of chemicals at an EU level rather than at national level?  

A. 

What's the issue? 

The principle of subsidiarity requires that legislating at the EU level should occur only when 
and where there is evident added-value of doing so, i.e. where necessary and more effective. 
This section looks at whether there is added value in regulating chemicals at the EU level as 
opposed to solely at the national level and, if there is one, what this added value is.  

B. 

What are the findings? 

Conclusions 

The harmonisation of chemicals legislation at the EU level has proved important and largely 
successful  in  terms  of  the  protection  of  human  health  and  the  environment  as  well  as  the 
functioning  of  the  internal  market.  The  sharing  of  knowledge  and  resources  and  the 
application of common rules and standards across the EU has resulted in significant positive 
economic, health and environmental impacts that would not have been possible to achieve on 
the basis of legislation at the Member State level alone. The EU chemicals legislation is also 
the reference point for international standards in several areas which helps to reduce potential 
trade frictions as well as address transboundary chemicals related issues.  

In line with the subsidiarity and proportionality principles, the approach of the EU chemicals 
legislation guarantees that decisions are taken as closely as possible to the citizen and where 
necessary and more effective, at the EU level. The core pieces of chemicals legislation such as 
the  CLP,  the  Plant  Protection  and  Biocidal  Products  Regulations  collectively  provide  for  a 
harmonised framework (based on article 114 of the TFEU). Some other pieces of legislation 
in the chemicals legal framework, e.g. the waste legislation and other pieces of environmental 
legislation (based on Article 192 of the TFEU) and the occupational safety and health (OSH) 
legislation (Article 153 TFEU) establish a system of basic principles, rules and requirements 
which must be transposed into national law while leaving room for Member States to be more 

104 

 
 
stringent  or  go  further  in  their  implementation.  These  pieces  of  legislation  typically  include 
objectives  such  as  the  protection  of  human  health  and  the  environment,  often  with  some 
further specifications of what aspects of environment  and natural resources are of particular 
importance.  

Risks to human health and the environment stemming from exposure to hazardous chemicals 
are  similar  across  the  EU.  Harmonised  rules,  procedures,  requirements,  definitions,  criteria 
etc.  allow  for  a  comprehensive  risk  assessment  of  exposure  to  hazardous  chemicals.  This 
approach  helps  ensure  an  equal  level  of  protection  of  human  health  and  the  environment 
across the EU while also taking account of variations in local conditions. It also helps ensure 
that  the  same  amount  of  information  about  chemical  risks  and  hazards  is  made  available  to 
public  authorities,  citizens,  consumers,  chemicals  industry  and  downstream  users  across  the 
EU.  

Regulating  the  risk  management  of  chemicals  at  the  EU  level  also  increases  efficiency. 
Hazard  and  risk  assessment  processes  often  require  a  high  level  of  scientific  expertise  and 
therefore can imply high costs for public authorities, especially in smaller Member States. By 
harmonising  and  coordinating  the  hazard  and  risk  assessment  processes  at  the  EU  level 
(combined  with  the  principle  of  reversed  burden  of  proof  and  self-classification  or  self 
assessment of conformity by industry), the EU chemicals legislation helps avoid duplication 
of  effort  between  Member  States.  This  results  in  cost  savings  for  public  authorities  as 
workload and expertise are shared and it reduces the administrative burden and complexity for 
the companies that operate in many different Member States. It also contributes to improving 
the state of knowledge, quality and availability of data needed for risk management decision 
making.  

A system that guarantees the safety of products placed on the EU market and often produced 
via complex and global value chains is needed in order to protect consumers' interests and to 
secure their trust both in European companies and those who produce outside the EU. Such a 
system is established by the EU chemicals legislation. The Eurobarometer survey312 showed 
that  EU  citizens  consider  products  manufactured  in  the  EU  to  contain  safer  chemicals  than 
those  imported  from  outside  the  EU.  This  indicates  a  higher  level  of  confidence  in  the  EU 
regulatory framework for manufactured products compared to regulatory regimes abroad. The 
EU  chemicals  legislation  is,  potentially,  a  driver  of  innovation  although  currently  available 
evidence does not allow a clear conclusion to be drawn about whether or not the legislation is 
fostering innovation and substitution.   

EU  chemicals  legislation  has  become  a  benchmark  for  development  of  chemical  risk 
management  rules,  both  at  the  international  level  as  well  as  in  other  countries  and  regions. 
European  companies  also  benefit  from  perception  of  quality  of  EU  products  in  non-EU 
country markets which has brought important advantages in terms of international trade.   

The EU chemicals legislation has also helped to decrease the barriers to, and costs, of intra-
EU trade by limiting the application of multiple and potentially diverging national rules with 
limited  territorial  coverage  and  existing  only  in  the  applicable  national  language(s).313 

312 Special Eurobarometer 456 
313 Different stakeholders (industry and NGOs and consumer organisations), as well as Member States and the 
European  Parliament  have  identified  food  contact  materials  non  regulated  at  the  EU  level  as  one  of  the  areas 

105 

 
 
                                                 
 
Regulating the risk management of chemicals at an EU level also plays a role in preventing 
unfair  competition  between  Member  States  e.g.  based  on  low  standards  for  working 
conditions.  

Stakeholders  (industry,  NGOs)  as  well  as  national  authorities  were  of  an  opinion  that  the 
harmonised  community-wide  approach  in  the  chemicals  legal  framework  is  paramount  to 
achievement  of  its  core  policy  objectives  and  that  there  is  clearly  an  added  value  in  taking 
action  at  the  EU  level  versus  a  situation  with  28  different  sets  of  chemicals  legislation  and 
standards at Member State level. This includes the facilitation of sharing of knowledge, data, 
expertise  and  methodology  as  well  as  pooling  of  resources  between  Member  States,  EU 
institutions and other stakeholders.  

The transparency of the process and equal, reciprocal access to information and the quality of 
information  have  improved  considerably  through  the  implementation  of  the  current 
legislation, as also highlighted by different stakeholders.   

10 CONCLUSIONS 

The different pieces of chemicals-related EU legislation adopted since late 1960s have, over 
time,  effectively  become  a  legal  framework.  All  of  them  have  been  amended,  updated  or 
replaced  at  least  once.  Many  of  the  Directives  have  also  been  repealed,  codified  or  have 
become Regulations (see Annex 4 Table 2). Yet, how all these pieces work together has never 
been  assessed.  This  Fitness  Check  is  the  first  evaluation  of  most  of  this  complex  and 
extensive legal framework. It is important to note, however, that the REACH Regulation as 
well  as  the  pharmaceutical  and  veterinary  products  legislation  are  outside  the  scope  of  the 
Fitness Check. This presented a number of challenges, particularly in terms of disentangling 
costs and benefits estimates where REACH is often an integral part of the policy mix that is 
responsible for the costs and benefits of exposure reductions. 

The  framework’s  fitness  for  purpose  was  assessed  against  the  core  policy  objectives  of 
ensuring  a  high  level  of  protection  of  human  health  and  the  environment,  ensuring  a  well-
functioning internal market and enhancing EU business’ competitiveness and innovation in an 
effective,  efficient  and  coherent  manner.  The  focus  was  primarily  on  the  chemical  hazard 
assessment, risk assessment and risk management decision processes. The Fitness Check also 
paid attention to the framework’s relevance and capability to respond to stakeholder concerns 
and future challenges such as the transition towards a more circular economy.  

The  Fitness  Check  takes  into  consideration  the  findings  presented  in  the  related  'Interface' 
Communication.314  Together  with  the  findings  of  the  REACH  Evaluation315,  it  helps  to 
provide a complete picture in term of taking stock of the current EU’s chemicals legislation. 

where more harmonised approach would bring additional benefits.  Safety requirements for furniture is another 
example of area where more harmonised approach could bring additional benefits, as identified by stakeholders 
(environmental NGOs, industry, cancer organisations, fire fighters and labour unions). 
314  Communication  on  the  implementation  of  the  circular  economy  package:  options  to  address  the  interface 
between chemical, product and waste legislation; COM(2018) 32 final; SWD(2018) 20 final 
315 Communication from the Commission to the European Parliament, the Council and the European Economic 
and  Social  Committee  on  Commission  General  Report  on  the  operation  of  REACH  and  review  of  certain 
elements Conclusions and Actions; 5 March 2018; COM(2018) 116 final and SWD(2018) 58 final 

106 

 
 
                                                                                                                                                         
Furthermore, a number of ongoing legislation-specific evaluations (see Annex 4 Table 4) will 
complement  the  findings  of  this  Fitness  Check,  especially  regarding  the  state  of  play, 
implementation and enforcement of the legislation as well as costs and benefits generated. All 
these different evaluations will help ensure that future improvements and refinements made in 
these policy areas are well-founded, coherent and well-focused.  

A comprehensive and generally well-functioning framework 

The Fitness Check evaluation found that, overall, the EU framework of chemicals legislation 
is  fit  for  purpose  in  terms  of  meeting  the  core  policy  objectives  of  ensuring  a  high  level  of 
protection  of  human  health  and  the  environment,  ensuring  the  efficient  functioning  of  the 
internal market while enhancing competitiveness and innovation. These core policy objectives 
remain highly relevant as well as the framework’s basic components and its current approach. 
The added value of policy action at the EU level is high.   

Although a range of on-going and emerging health and environmental concerns related to the 
exposure to hazardous chemicals remain (see Section 5.1.1), the EU chemicals legislation has 
clearly  led  to  significant  benefits  in  terms  of  reduced  and  avoided  negative  health  and 
environmental  impacts  for  regulated  hazardous  substances  and  in  terms  of  the  efficient 
functioning  of  the  internal  market  (see  Section  6.1.2).  Where  these  benefits  can  be  reliably 
monetised, the outcomes are often significant. For example, the benefits of reduced poisoning 
incidents,  occupational skin  and respiratory diseases and occupational cancers amount  to  an 
estimated  EUR  217  –  338  million  per  year.  As  another  example,  the  better  control  and 
management  of  plant  protection  products  have  resulted  in  reduced  negative  impacts  on 
ecosystem, including pollination services and have thus generated estimated benefits of EUR 
15  –  50  billion  per  year.  In  addition,  estimated benefits  of EUR  500  million  per  year result 
from  avoided  costs  of  removing  pesticides  from  drinking  water  supplies  (see  Section  6.1.2 
Table 4 Selected monetised environmental and health benefits of reduced hazardous chemical 
exposures. The level of harmonisation achieved across the EU has played a significant role. In 
addition,  the  EU  is  considered  as  a  frontrunner  in  terms  of  chemicals  innovation.  The  EU 
remains  the  largest  chemicals  exporting  market  in  the  world  and  is  internationally 
competitive.  

Key  benefit  drivers  include  avoided  healthcare  costs,  avoided  productivity  losses  (due  to 
avoided lost working  hours  as  a result of illness or  premature death), avoided suffering  and 
premature  deaths,  avoided  remediation  costs  (including  wastewater  and  drinking  water 
treatment costs) and avoided degradation of environmental/eco-system services.  

The  EU  chemicals  legislation  has  decreased  the  barriers  to,  and  costs,  of  intra-EU  trade  by 
limiting the application of potentially diverging national rules with limited territorial coverage 
and existing only in the applicable national language(s). The EU chemicals legislation is also 
the reference point for international standards in several areas, which helps to reduce potential 
trade frictions as well as address transboundary chemicals related issues. 

Generic  and  specific  risk  management  approaches  both  have  their  role  to  play  within  the 
framework  of  EU  chemicals  legislation.  Regarding  the  balance  between  the  two,  the 
preferences  of  different  stakeholder  groups  vary  considerably,  with  industry  having  a 
tendency  to  prefer  a  more  extensive  use  of  the  specific  approach,  NGOs  tending  to  have  a 
higher preference for the generic approach, and many Member States expressing satisfaction 

107 

 
 
with  the  current  balance.  There  is  room  for  improvement  in  the  application  of  both 
approaches, particularly in terms of:  

  speeding up the identification and risk assessment of hazardous chemicals; and 
  ensuring the concerns of, impacts on and implications for different stakeholder groups 
are  properly  identified  and  taken  into  consideration  in  order  to  avoid  any 
disproportionate or unintended consequences. 

Achieving  the  core  objectives  of  the  EU  chemicals  legislation  is  predicated  on  sound 
scientific  knowledge  and  robust  and  comprehensive  data  that  is  reliable,  comparable  and 
reproducible. Within the EU, the quality and the availability of data needed to perform a risk 
assessment  and  to  manage  risks  has  improved  considerably.  The  EU’s  knowledge  base  on 
chemical  hazards  and  risk  is  now  an  important  asset.  Much  of  this  improvement  in  data 
reflects  the  shift  of  responsibility  from  EU  and  Member  State  authorities  to  industry  for 
generating the necessary data for hazard and risk assessment. It has, therefore, been primarily 
resourced and underpinned by industry assuming the responsibility of ensuring the safe use of 
chemicals  placed  on  the  market.  The  significant  investment  in  the  establishment  of 
independent regulatory EU chemicals agencies (EFSA, ECHA, EMA) and specific scientific 
committees has also been instrumental in the improvement of data quality and its availability 
as well as to provide expertise and support to the EU decision making process.   

The CLP Regulation was identified as one of the most efficient aspects of the functioning of 
the EU chemicals legislative framework, as it allows hazard classification of a wide range of 
chemicals  without  creating  a  disproportionate  administrative  burden  for  public  authorities 
while  focusing  their  resources  on  the  most  relevant  substances  for  human  health  and 
environmental protection. The clear separation of hazard assessment and hazard classification 
from  the  risk  assessment  and  risk  management  decision  making  steps  is  an  important 
cornerstone of the framework’s effectiveness and should be safeguarded. The CLP Regulation 
ensures  the  coherence  of  hazard  assessment  and  classification  at  the  EU  level  with  what  is 
done at the international level (through the UN Globally Harmonised System (GHS)). 

The  scope  and  stringency  of  the  hazard  and  risk  assessment  processes  stipulated  within  the 
EU chemicals legislation are tailored to different needs under different pieces of legislation. 
After more than 50 years of continuous efforts and improvements, the linkages between the 
different  pieces  of  EU  chemicals  legislation  are  now  generally  well  established  and 
functioning reasonably well. The level of transparency and stakeholder involvement built into 
the various hazard and risk assessment/management processes has improved over time and is 
considered by the majority of stakeholders to be good. 

Burden reduction and simplification 

The overall regulatory costs of the EU chemicals legislation for EU industry are estimated to 
be approximately several billion euros per year (see Section 6.1.1).  

Depending on the piece of legislation, the main cost drivers for industry are data generation 
(hazards,  chemical  uses,  exposures,  etc.),  staff  training,  biomonitoring  of  workers  and 
monitoring of operational conditions, and control costs. For public authorities the main costs 
are generated by enforcement and monitoring activities. 

While  it  was  not  possible  to  establish  an  overall  quantified  cost-benefit  ratio  for  the 
framework  of  EU  chemicals  legislation  and  thus  conclude  on  their  proportionality,  the 

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evidence clearly indicates that both the costs and the benefits generated by the EU chemicals 
legislation are significant. The Fitness Check, however, identified a number of opportunities 
for burden reduction and simplification, both for companies and for Member State authorities, 
the most significant of these being as follows: 

  Small  and  Medium  Sized  Enterprises  (SMEs):  SMEs  are  more  affected  than  bigger 
companies  by  certain  aspects  of  the  EU  chemicals  legislation  such  as  understanding 
and  compliance  with  often  interlinked  legal  obligations  or  opportunities  to  actively 
take part in decision making processes. Increased involvement of these stakeholders in 
the decision making processes can be improved and will help ensure that all interests 
at  stake  are  properly  taken  into  consideration.  This  will  also  improve  their 
understanding  of  their  legal  obligations  and  thus  provide  for  a  predictable,  fair  and 
trusted environment that continues to ensure a high level of protection of human health 
and the environment and a well-functioning internal market.     

  Data  sharing:  the  availability  and  quality  of  data  have  improved  and  are  generally 
good.  However,  some  difficulties  in  data  sharing  across  legal  clusters  are  still 
encountered.  This  affects  mainly  industry  that  needs  to  generate  data  for  regulatory 
purposes.  These  difficulties  occur  for  a  variety  of  reasons,  including  general  data 
confidentiality rules and intellectual property rights but also because of the lack of a 
centralised  access  point  or  the  lack  of  awareness  of  what  exists  in  the  different 
databases.  It  leads  to  a  certain  duplication  of  effort  where  the  nature  of  assessment 
made  is  similar.  This  can  generate  extra  costs,  as  well  as  longer-than-necessary 
timeframes  and  lead  to  duplication  of  testing.  A  comprehensive  mapping  of  the 
existing  information  and  an  assessment  of  how  to  optimise  the  use  of  the  available 
information are needed.   

  Hazard  communication  to  consumers:  not  all  the  opportunities  to  improve  and 
simplify  the  communication  of  chemical  hazards  and  safety  information  towards 
consumers have been seized e.g. the opportunities offered by digital technologies such 
as Q-R codes have not yet been assessed. The communication of hazards to consumers 
via  pictograms  and  labels  can  also  be  improved  e.g.  labels  overloaded  with 
information and difficult to read with some duplication of certain information due to 
overlaps in legal requirements or because of the need to include hazard statements in 
all EU languages.  

  Predominant  substance-by-substance  approach  to  risk  assessment  and  management: 
using grouping approaches to identify and risk assess groups of chemicals with similar 
hazard  and  risk  profiles  as  means  of  speeding  up  the  risk  management  decision 
process and avoiding regrettable substitutions (that can be costly both to industry and 
to  the  society  in  general  in  terms  of  health  and  environmental  impacts)  warrants 
further attention.   

  Risk  of  duplication  of  efforts  by  different  EU  agencies  and  scientific  committees: 
these  bodies  provide  the  Commission  with  scientific  advice  and  hazard/risk 
assessments.  There  are  opportunities  for  simplifying  their  current  setup  and 
streamlining  their  activities  thus  making  the  functioning  of  the  framework  more 
efficient (i.e. avoiding duplication of efforts) and more reliable (i.e. reducing the risk 
of potentially diverging outcomes of hazard/risk assessments). 

  Lack of clarity with respect to how to apply the CLP bridging principles method for 
the  classification  of  mixtures:  the  clarification  on  how  to  apply  these  principles  to 

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mixtures will improve the effectiveness of this method. It will also avoid discrepancies 
in  interpretation  and  acceptance  of  hazard  classification  by  Member  States.  Actions 
taken  so  far  by  the  Commission  to  address  this  issue,  including  guidance  on  the 
harmonised application of the legal requirements, need to be pursued.  

Needs for improvement 

Even  though  the  objectives  of  legislation  within  the  scope  of  this  Fitness  Check  are  not 
always the same, the legal acts are generally coherent in how they attempt to reach the stated 
objectives, as illustrated by the use of similar underpinning legal mechanisms to do so. One of 
the mechanisms used is the reverse burden of proof by industry complemented by the use of 
self-assessment of conformity.316 Where the outcome of the risk assessment is to be checked 
by a public authority thus determining whether, for example, a product can be used or placed 
on the market or an activity can be pursued, the quality of risk assessments done tends to be 
good.  For  the  pieces  of  legislation  where  the  underpinning  mechanism  relies  on  the 
presumption  of  compliance  with  the  existing  rules,  information  from  enforcement  activities 
carried  out  is  scarce  and  therefore  does  not  allow  to  conclude  on  the  quality  of  the  self-
assesment of conformity carried out. 

The current state of knowledge regarding exposure to hazardous chemicals needs to be further 
improved.  Because  industry  and  public  authorities  may  be  unaware  of  many  uses  of 
hazardous chemicals and there is only limited information available about the overall volumes 
of  hazardous  chemicals  emitted/released  into  the  environment,  their  capacity  to  develop 
realistic, acceptable and robust exposure scenarios can be hampered. Exposures to hazardous 
chemicals are known to or are strongly suspected of play a role in impacts on human health 
and the environment e.g. cancers, reproductive diseases, respiratory sensitisation, declines in 
insect and bird populations and water and soil pollution. In this regard, a number of on-going 
exposure  situations  to  hazardous  chemicals  warrant  further  attention  (e.g.  endocrine 
disrupting  chemicals  and  hazardous  chemical  exposures  of  the  aquatic  and  terrestrial 
compartments).  However,  there  are  still  uncertainties  regarding  the  extent  to  which  the 
negative  trends  can  be  attributed  to  exposure  to  hazardous  chemicals  rather  than  to  other 
factors such as lifestyle. This hampers the legislator’s capability to provide with certainty the 
most  appropriate  answers.  This  also  renders  the  practical  application  of  the  precautionary 
principle  in  the  area  of  chemicals  risk  assessment  and  management  particularly  challenging 
for the decision makers.  

Although the precautionary principle is explicitly taken into account in the design of various 
pieces  of  chemicals  legislation,  to  date,  it  has  actually  been  applied  in  very  few  instances 
under the various pieces of EU chemicals legislation. The appropriate use of the precautionary 
principle  is  an  important  element  in  helping  to  ensure  on  the  one  hand  the  protection  of 
human health and  the environment and the avoidance of potential costly future  impacts and 

316 Reverse burden of proof means that industry is responsible for ensuring the safe use of their chemicals and 
therefore  carrying  out  the  risk  assessment  and  ensuring  the  risk  management  of  their  chemicals,  including 
testing. Public authorities are responsible for checking if this obligation is properly implemented and, where not, 
to  quickly  and  efficiently  propose  measures  to  manage  risks.  Self-assessment  of  conformity  means  that  an 
economic operator declares on his sole responsibility that the products concerned satisfy the requirements of the 
legislative  instrument  that apply  to  them  in  which  case the  economic  operator benefits from  a  presumption  of 
conformity. 

110 

 
 
                                                 
remediation,  and  on  the  other  hand  the  avoidance  of  disproportionate  or  unnecessary  risk 
management  costs.  The  EU  efforts  in  collecting  human  health  exposure  data  need  to  be 
pursued. More data on hazardous chemical uses and their fate need to be collected. So far the 
Commission  has  funded  the  European  Human  Biomonitoring  Initiative  (HBM4EU). 
However, a similar initiative for animals, plants and eco-systems is currently lacking although 
the  Commission’s  development  of  the  Information  Platform  for  Chemical  Monitoring 
(IPCHEM)317 can contribute to addressing this gap.    

Several  other  important  areas  for  future  improvement  or  which  warrant  further  assessment 
include: 

  Better  understanding  of  the  impacts  of  hazardous  chemicals  on  the  environment, 
biodiversity and eco-system resilience. This includes the assessment of the benefits of 
introducing  additional  hazard  classes  in  the  CLP  Regulation  (e.g.  persistent,  bio-
accumulative,  toxic  and  very  persistent  and  very  bio-accumulative  substances  and 
terrestrial toxicity, endocrine disruptors).  
  Better  understanding  and  management  of 

the  potential  human  health  and 
environmental risks associated with exposures to substances in articles (e.g. consumer 
products). The issue of substances in articles is particularly important as the EU is in 
the  process  of  shifting  towards  a  more  circular  economy.  This  implies  the  need  for 
better traceability of substances of concern in articles  (and communication of this to 
consumers and end-users), since such a shift will involve considerable changes in the 
way  materials  and  articles  are  produced,  used  and  disposed  of.  This  warrants 
consideration of how to manage the health and environmental risks associated with the 
hazardous  substances  that  pass  through  several  cycles  of  production,  use,  and 
recycling.  

  Addressing  combination  effects  of  different  hazardous  chemicals  as  well  as  the 

combined exposure via different routes.  
 
Improving consistency in identifying and managing the risks posed by allergens.  
  Ensuring consistency and intensity of actions to protect vulnerable population groups, 
including those that are particularly sensitive to endocrine disruptors, such as prenatal 
and young infants, adolescents, etc. 

  Gathering  more  evidence  regarding  neurotoxicity,  immunotoxicity  and  respiratory 
sensitization  to  determine  the  extent  and  significance  of  potential  weaknesses  in  the 
risk assessment of substances with these properties.  

  Addressing  the  inconsistencies  that  occur  regarding  risk  management  decisions  for 
endocrine disruptors, persistent, bio-accumulative, toxic and very persistent and very 
bio-accumulative  substances  and  substances  fulfilling  the  classification  criteria  for 
specific target organ toxicity. In some but not all pieces of legislation, they are subject 
to risk management measures based on generic risk considerations. 

  Addressing risks posed by endocrine disruptors. The need for a coherent approach to 
the  identification  of  endocrine  disruptors  across  all  relevant  Union  legislation 

317 https://ipchem.jrc.ec.europa.eu/RDSIdiscovery/ipchem/index.html  

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approach, based on the broadly accepted definition of the World Health Organisation 
is a key element of the recently adopted EU strategy on endocrine disruptors.318  
  Boosting substitution of the most hazardous chemicals with less hazardous chemicals 
or  non-chemical  solutions  where  alternative  substances  or  technologies  are  more 
sustainable  and  economically  and  technically  viable.  Efforts  of  supporting  and 
encouraging  research  and  innovation  to  catalyse  the  shift  towards  more  sustainable 
chemicals need to be accelerated and pursued. 
Improving  the  reliability  and  consistency  of  the  industry  self-classifications  of 
chemical hazards under the CLP Regulation. The current concerns need to be further 
investigated as these affect the value of the Classification and Labelling Inventory as a 
hazard communication tool. 

 

318 Communication from the Commission to the European Parliament, the Council and the European Economic 
and  Social  Committee  and  the  Committee  of  the  Regions  ‘Towards  a  comprehensive  European  Union 
Framework on endocrine disruptors’ COM(2018) 734 final  

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11  LIST OF ANNEXES  

Annex 1 Procedural information 

Annex 2 Synopsis report: stakeholder consultation activities  

Annex 3 Methods and analytical models  

Annex  4  Information  regarding  the  legal  scope  of  the  Fitness  Check,  its  supporting  studies 
and other relevant sources of information  

Annex 5 Effectiveness 

Annex 6 Efficiency 

Annex  7  Coherence  of  hazard/risk  assessment  and  risk  management  procedures  (CMRs, 
PBTs/vPvBs, EDs)  

Annex 8 EU Approaches to Chemicals Risk Management: updated  

Annex 9 Glossary  

Annex 10 Evaluation questions  

Annex 11 Overview of costs – benefits identified in the Fitness Check  

113