Evaluation of EU Directives 2004/9/EC and 2004/10/EC on the Good Laboratory Practice (GLP)
Date: 2026-02-13
Institutions: Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs, European Commission
Subjects: single market

EUROPEAN COMMISSION 
DIRECTORATE-GENERAL INTERNAL MARKET, INDUSTRY, ENTREPRENEURSHIP 
AND SMES 
Chemicals, Bioeconomy and Retail 
F.2 – Bioeconomy, Chemicals & Cosmetics 

Factual Summary Report on the Public 
consultation “Ensuring the quality of 
data from chemical testing – the Good 
Laboratory Practice Directives 
(evaluation)” 

This  document  should  be  regarded  solely  as  a  summary  of  the  contributions  from 
stakeholders.  It  cannot  in  any  circumstances  be  regarded  as  an  official  position  of  the 
European Commission or its services. Responses given as part of the public consultation 
cannot be considered a representative sample of the views of the EU population. 

This factual summary report provides an overview of the input received during the public 
consultation  on  the  evaluation  of  the  Good  Laboratory  Practice  (GLP)  Directives 
2004/9/EC and 2004/10/EC. The consultation aimed to gather stakeholder views on the 
effectiveness, efficiency, relevance, coherence, and EU added value of the current GLP 
framework. Given the limited number of responses (1).  The consultation was conducted 
via  the  ‘Have  Your  Say’  portal (2),  with  all  contributions  submitted  electronically.  The 
European Commission performed standard checks to ensure the uniqueness and validity 
of responses. No responses were discarded, and no organized campaigns were identified. 

This  summary  report  is  structured  to  reflect  the  contributions  as  received,  without 
interpretation or qualification. It includes basic statistics on participant demographics and 
a summary of the replies.  

1.  PARTICIPATION OVERVIEW 

The consultation received 11 contributions from a diverse range of stakeholders, including 
companies,  public  authorities,  business  associations,  and  individual  EU  citizens.  The 

(1) 

 Of the 11 contributions received, 10 were submitted through the EU survey platform. One additional 
response,  while  prepared  using  the  EU  survey  template,  was  submitted  via  email  due  to  technical 
difficulties that were resolved after the public consultation deadline. 

(2)  https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14134-Ensuring-the-quality-

of-data-from-chemical-testing-the-Good-Laboratory-Practice-Directives-evaluation-/public-
consultation_en  

Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË  

GROW-GLP@ec.europa.eu 

 
 
 
 
 
majority of respondents contributed in English (n=6), followed by Italian (n=2), with single 
contributions in Spanish, Portuguese, and Romanian.  

In terms of stakeholder groups, 5 out of 11 respondents (45%) were companies, followed 
by  public  authorities  (n=3,  or  27%),  business  associations  (n=2,  or  18%),  and  other 
stakeholders (n=1, or 9%). No replies have been received by citizens. Geographically, 9 
out of 11 respondents (82%) were from EU  countries, while 2 respondents (18%) were 
from non-EU countries. The distribution of responses by stakeholder group and geographic 
location is shown in the graph below. 

Figure 1 - Statistics for the public consultation responses 

2.  SUMMARY OF CONTRIBUTIONS 

The survey aimed to gather information on the perceived benefits and drawbacks of the 
GLP Directives, as well as their impact on various stakeholders. Specifically: 

•  Ensuring quality, integrity, and reliability: 6 out of 11 respondents replied that the 
GLP Directives ensure the quality, integrity, and reliability of non-clinical safety 
tests to a very large extent. The remaining 5 out of 11 replied to a large extent. 

•  Mutual  recognition  of  data:  5  out  of  11  respondents  indicated  that  mutual 
recognition  of  data  through  the  GLP  principles  has  saved  time  and  economic 
resources  within  their  organisation  to  a  very  large  extent,  while  4  out  of  11 
indicated to a large extent and the remaining 2 to a moderate extent. 

•  Contribution of the GLP Directives: the respondents stated that the GLP Directives 

have contributed to: 

2 

 
 
 
Preventing 
fraudulent 
practices 

Avoiding 
double 
testing 

Promoting 
the  quality 
and validity 
of  data  for 
non-clinical 
safety 
testing 

Harmonising 
rules 
for 
inspection and 
audit  of  test 
facilities 

Reducing 
non-tariff 
trade 
barriers of 
chemicals 
within  the 
EU 

Reducing non-
trade 
tariff 
of 
barriers 
chemicals 
internationally 

Increasing 
the  safety 
of 
chemicals 
in the EU 

To a very large 
extent 

To a large 
extent 

To a moderate 
extent 

To a limited 
extent 

Not at all 

Do not 
know/Prefer 
not to say 

6 

5 

0 

0 

0 

0 

1 

8 

1 

1 

0 

0 

0 

7 

3 

1 

0 

0 

4 

3 

4 

0 

0 

0 

1 

3 

4 

1 

1 

1 

2 

4 

2 

1 

1 

1 

4 

3 

4 

0 

0 

0 

•  When  asked  to  which  extent  the  GLP  Directives  still  contribute  today  to  the 
objectives of the legislation, the respondents provided the following feedback: 

Promoting 
the quality 
and 
validity of 
data for 
non-
clinical 
safety 
testing 

Preventing 
fraudulent 
practices 

Standardising 
data 
requirements 
to avoid 
double testing 

Harmonising 
rules for 
inspection 
and audit of 
test facilities 

Reducing non-
tariff trade 
barriers of 
chemicals 
internationally 

Increasing 
the safety 
of 
chemicals 
in the EU 

Reducing 
non-tariff 
trade 
barriers 
of 
chemicals 
within the 
EU 

To a very 
large extent 

To a large 
extent 

To a 
moderate 
extent 

To a large 
extent 

Not at all 

Do not 
know/Prefer 
not to say 

5 

5 

1 

0 

0 

0 

2 

7 

1 

1 

0 

0 

3 

4 

2 

2 

0 

0 

5 

2 

4 

0 

0 

0 

1 

3 

5 

0 

1 

1 

2 

4 

2 

1 

1 

1 

5 

2 

3 

1 

0 

0 

•  Scope  and  adequacy:  8  out  of  11  respondents  believe  that  the  scope  of  the 
Directives is adequate. In particular, 3 respondents affirming their adequacy, stated 
that they are adequate, still relevant, or that the principles of good practice are clear 
and appropriate. Another respondent mentioned that the scope is adequate as it is 

3 

 
 
 
 
 
applied through specific product norms. One respondent noted that the Directives 
ensure  reliable,  traceable,  and  reproducible  safety  studies,  which  is  essential  for 
protecting human health and the environment. Then, 2 respondents suggested that 
the Directives could be improved, with 1 recommending that they be more detailed 
with examples, and 1 stating that certain criteria do not influence quality and more 
inspection  is  needed.  Additionally,  1  respondent  commented  on  inconsistent 
application  of  the  Directives  across  states,  citing  insufficient  harmonisation. 
Finally,  1 
importance  of  ensuring  proper 
implementation of GLP in regulatory contexts to prevent the misuse of new or non-
validated methods. 

respondent  highlighted 

the 

•  Administrative burden: when investigating how burdensome are some obligations 
and  activities  related  to  complying  with  the  GLP  Directives,  the  respondents 
provided the following feedback: 

o  Maintaining administrative and office records related to GLP compliance: 
very burdensome for 2 out 6 respondents, to a moderate extend for 2 out of 
6 respondents and somewhat burdensome for the remaining 2 respondents. 

o  Preparing  technical  dossiers  for  GLP  studies  (e.g.,  for  regulatory 
submission): to a moderate extend for 4 out of 6 respondents and somewhat 
burdensome for the remaining 2 respondents. 

o  Submitting  reports,  data,  and  statistics  to  competent  authorities:  to  a 
moderate extend for 4 out of 9 respondents, somewhat burdensome for 4 
other respondents and not at all burdensome for the remaining respondent. 

o  Documenting and labelling GLP-compliant studies: very burdensome for 2 
out  6  respondents,  to  a  moderate  extend  for  2  out  of  6  respondents  and 
somewhat burdensome for the remaining 2 respondents. 

o  Record  keeping  related  to  GLP  compliance  (e.g.,  QA  records,  study 
protocols): very burdensome for 3 out 10 respondents, to a moderate extend 
for  4  out  of  10  respondents,  somewhat  burdensome  for  the  remaining  2 
respondents and not at all burdensome for the remaining respondent. 

o  Coordinating with OECD partners for mutual acceptance of data (MAD): 
half of the 6 respondents replied to a moderate extent burdensome, while 
the other half somewhat burdensome. 

o  Designing and conducting GLP-compliant studies: similarly to the previous 
question, half of the 6 respondents replied to a moderate extent burdensome, 
while the other half somewhat burdensome.   

o  Training personnel on GLP compliance requirements: one responded very 
burdensome, 2 to a moderate extent burdensome and another person replied 
somewhat burdensome. 

o  Implementing internal quality assurance and compliance systems: half of 
the 6 respondents replied to a moderate extent burdensome, while the other 
half somewhat burdensome 

4 

 
 
o  Collaborating with monitoring authorities during inspections: there is a lack 
of consensus on this reply as one respondent indicated this element to be 
very burdensome and 2 indicated to a moderate extent burdensome, while 
other respondents replied somewhat burdensome (n=2) or not at all (n=1).

o  Developing  and  maintaining  compliance  tracking  systems:  two  replies 
selected  for  this  point.  One  respondent  indicating  that  the  systems  are 
somewhat burdensome, while another to a moderate extend burdensome. 

o  Taking corrective actions to address GLP non-compliance: two replies were 
received concurred that taking corrective actions is somewhat burdensome. 

o  Re-inspections for non-compliance (including follow-up inspections): one 
respondent indicated that this is to a moderate extend burdensome, while 
another indicated not at all.  

•  EU  added  value:  on  the  questions  asking  whether  the  objectives  of  the  GLP 
Directives are better achieved when implemented at the EU level, rather than at the 
individual national level, more  than half  of the  respondents (from  64%  to  82%) 
recognised  the  EU  added  value.  In  particular,  when  indicating  a  higher  level  of  
protecting human and environmental safety (8 out 11 respondents), ensuring trust 
and confidence in certain products (9 out 11 respondents), reducing trade barriers 
and costs in the internal market (8 out 11 respondents), monitoring compliance (9 
out  11  respondents),  handling  suspicions  of  non-compliance  (8  out  11 
respondents),  preventing  fraudulent  practices  (7  out  11  respondents),  ensuring 
high-quality  and  valid  data  for  safety  testing  of  test  items  contained  in 
pharmaceutical, pesticide, or cosmetic products, veterinary drugs as well as food 
and feed additives, and industrial chemicals (9 out 11 respondents), standardising 
data requirements to avoid double testing (8 out 11 respondents), and harmonising 
rules for inspection and audit (9 out 11 respondents). One respondent added that it 
is  important  to  ensure  the  proper  implementation  of  GLP  in  various  regulatory 
contexts in order to avoid the inappropriate use of new methods or non-validated 
methods for aspects that require regularity. The respondent added that GLP also 
ensures establishing robust comparisons and/or justifications (from both a scientific 
and regulatory perspective) that do not provoke debate/controversial interpretation. 

•  Sectoral  impact  in  case  of  withdrawal  of  the  Directives:  according  to  the 
respondent,  the  sector  would  be  affected  if  the  Directives  were  repealed  very 
negatively;  especially  in  terms  of  barriers  to  trade  (4  out  11;  while  6  out  of  11 
replied negatively and one respondent mentioned no impact); of regulatory burden 
(6 out of 11; while 5 out of 11 replied negatively); of quality of test data (7 out of 
11; while 4 replied “negatively”); of assessment of hazards (6 out of 11; 2 out of 
11 replied negatively and 2 replied no impact). The potential repeal  of the GLP 
Directives has sparked additional concerns: 4 respondents noted that the Directives 
have reached their objectives, remain relevant, and continue to help organisations 
meet customer requirements and respond to stakeholder needs. 1 respondent raised 
concerns  about  the  challenges  and  costs  associated  with  implementing  and 
maintaining  GLP  compliance,  including  the  significant  investment  required  for 
digitalisation, personnel training, and procedure adaptation. 1 respondent pointed 
out that the Directives may not be fully aligned with current developments, such as 
new  OECD  guidelines,  advisory  documents,  and  emerging  technologies  like 

5 

 
 
 
artificial  intelligence.  1  respondent  noted  that  well-performed  academic  studies 
may  not  always  be  GLP  compliant  due  to  certain  demanding  requirements. 
Additionally, 1  respondent mentioned that it is  very  expensive  to maintain  GLP 
compliance.  Overall,  the  comments  suggest  that  while  the  GLP  Directives  have 
been effective in achieving their objectives, there may be areas where they could 
be improved or updated to reflect changing stakeholders' needs and technological 
advancements. 

•  When asking for which sectors they require or provide GLP-compliant studies, out 
of  the 11 replies received, the most common sectors  are  Industrial  chemicals (8 
responses),  Pesticides/Biocides  (7  responses),  and  Cosmetics  (5  responses), 
followed by Food and feed additives (4 responses), Pharmaceutical (5 responses), 
and Laboratory service  provider (3 responses),  while  EU  agency,  National  GLP 
Monitoring authority, National GLP Regulatory authority, and Other accounted for 
2 responses or less. 

•  Finally, when asked to specify the areas of expertise you require or offer; out of the 
11 respondents the distribution is the following: Analytical and clinical chemistry 
testing:  9  responses  ;Environmental  toxicity  studies  on  aquatic  and  terrestrial 
organisms:  8  responses;  Physical-chemical  testing:  11  responses;  Mutagenicity 
studies: 6 responses; Residue studies: 7 responses; Studies on behaviour in water, 
soil and air; bioaccumulation: 8 responses; Studies on effects on mesocosms and 
natural ecosystems: 5 responses; Toxicity studies: 6 responses; Other: 2 responses. 

Sectors and Expertise 

The  respondents  represent  various  sectors,  including  cosmetics,  food  and  feed 
additives, industrial chemicals, pesticides/biocides, pharmaceuticals, and veterinary 
drugs.  The  areas  of  expertise  required  or  offered  include  analytical  and  clinical 
chemistry testing, environmental toxicity studies, physical-chemical testing, residue 
studies, and toxicity studies. 

Sector specific views 

Despite the limited number of respondents from industry, some specific views could be 
delineated from the responses received. In particular: 

• 

Industrial chemicals and Pesticides: respondents from these sectors emphasized the 
critical  role  of  GLP  in  ensuring  the  safety  and  efficacy  of  chemical  products. 
However,  they  also  pointed  to  delays  in  the  approval  process  for  new  testing 
methods, which can hinder innovation. 

•  Cosmetics and Food additives: stakeholders in these areas indicated the importance 
of GLP in supporting consumer safety but noted that the current framework could 
be more adaptive to the specific needs of these sectors. 

•  Public  authorities:  contributions  from  public  authorities  focused  on  the  need  for 
robust enforcement mechanisms to prevent non-compliance. They also suggested 
that greater resources should be allocated to support national competent authorities 
in their oversight roles. 

6