COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE European Union Strategic Approach to Pharmaceuticals in the Environment
Date: 2019-03-11
Institutions: Directorate-General for Environment, European Commission
Subjects: antimicrobial resistance, drug residue, environmental impact, environmental monitoring, environmental protection, pharmaceutical product, soil pollution, veterinary medicinal product, water pollution, water treatment

EN 

  EN 

   EUROPEAN COMMISSION  Brussels, 11.3.2019  COM(2019) 128 final  COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE   European Union Strategic Approach to Pharmaceuticals in the Environment  
 
 
COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN 
PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL 
COMMITTEE 

European Union Strategic Approach to Pharmaceuticals in the Environment 

1. 

INTRODUCTION 

in  relation 

to  antimicrobial  resistance, 

The  treatment  of  many  diseases  in  humans  and  animals  relies  on  access  to  effective 
pharmaceuticals1.  At  the  same  time,  pollution  caused  by  some  pharmaceuticals  is  an 
emerging  problem2,3,4,  with  well-documented  evidence  of  risks  to  the  environment  and, 
to  human  health.  Residues  of 
particularly 
pharmaceutical  products  may  enter  the  environment  during  their  manufacture,  use  and 
disposal. 
Article  8c  of  the  Priority  Substances  Directive  (2008/105/EC5  as  amended  by  Directive 
2013/39/EU6)  requires  the  European  Commission  to  propose  a  strategic  approach  to  the 
pollution  of  water  by  pharmaceutical  substances.  With  the  present  Communication,  the 
Commission  is  delivering  on  that  legal  obligation,  as  well  as  on  a  call  referred  to  in  the 
pharmacovigilance legislation to examine the scale of the problem of pollution of water and 
soils  with  pharmaceutical  residues7.  The  approach  supports  the  Commission’s  aim  of 
delivering  a  Europe  that  protects8,  and  fits  well  with  its  intention  to  work  towards  a 
sustainable Europe by 2030, guided by the Sustainable Development Goals9. It delivers on a 
commitment made by the Commission at the 3rd session of the United Nations Environment 
Assembly in 2017. It will contribute in particular to achieving Sustainable Development Goal 
6  on  clean  water  and  sanitation.  Furthermore,  as  a  component  of  the  Union's  One-Health 
Action Plan against Antimicrobial Resistance10, it can be seen as part-implementation of the 

1 The term "pharmaceuticals" is used here to refer to human or veterinary medicinal products. Usually, the active pharmaceutical ingredients 
(APIs) are the substances of concern, but also their metabolites and degradation products may be relevant, as well as some ingredients 
(excipients) other than the active substance and the packaging material.  

2  COM  (2008)  666  Final:  Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European  Economic  and 
Social  Committee  and  the  Committee  of  the  Regions  on  Safe,  Innovative  and  Accessible  Medicines:  A  Renewed  Vision  for  the 
Pharmaceutical Sector. 

3  Regulation  (EU)  No  1235/2010  of  the  European  Parliament  and  of  the  Council  of  15  December  2010  amending,  as  regards 
pharmacovigilance  of  medicinal  products  for  human  use,  Regulation  (EC)  No  726/2004  laying  down  Community  procedures  for  the 
authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and 
Regulation  (EC)  No  1394/2007  on  advanced  therapy  medicinal  products,  OJ  L  348,  31.12.2010,  p.  1;  Directive  2010/84/EU  of  the 
European  Parliament  and  of  the  Council  of  15  December  2010  amending,  as  regards  pharmacovigilance,  Directive  2001/83/EC  on  the 
Community code relating to medicinal products for human use, OJ L 348, 31.12.2010, p. 74  
4 https://ec.europa.eu/health/sites/health/files/scientific_committees/scheer/docs/scheer_s_002.pdf  
5 Directive 2008/105/EC, OJ L348, 24.12.2008, p.84  
6 Directive 2013/39/EU, OJ L 226, 24.8.2013,  p.1  
7 Recital 6 of Directive 2010/84/EU, OJ L 348, 31.12.2010, p.74 
8 http://europa.eu/rapid/press-release_IP-16-3500_en.htm 
9 https://ec.europa.eu/commission/publications/reflection-paper-towards-sustainable-europe-2030_en 
10 COM/2017/0339 final: Communication from the Commission to the Council and the European Parliament: A European One Health 
Action Plan against Antimicrobial Resistance (AMR) https://eur-lex.europa.eu/legal-content/GA/TXT/?uri=CELEX:52017DC0339  

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commitment  taken  in  the  context  of  the  G7/G20  and  World  Health  Organisation  regarding 
antimicrobial resistance. 
The approach has been informed by a number of studies and reports11, and by the results of 
public  and  targeted  stakeholder  consultations  launched  in  201712.    It  takes  account  of  the 
international dimension to the problem and circular economy considerations.   

The  pharmaceutical  sector  is  a  vibrant  industry,  with  a  drive  to  innovate.  Such  innovation 
could  support  "green  design",  for  example  the  development  of  products  that  pose  a  lower 
environmental risk or facilitate the recycling of waste water, and promote the use of greener 
manufacturing methods. Innovation in water and manure treatment may also be possible. In 
these  respects,  the  approach  will  contribute  to  the  Commission's  first  political  priority  of 
promoting jobs, growth and investment.  

2. 

PROBLEM DEFINITION 

2.1 

Concentrations of pharmaceuticals in the environment 

Residues of several pharmaceuticals have been found in surface and ground waters, soils and 
animal tissues across the Union at concentrations depending upon the pharmaceutical and the 
nature  and  proximity  of  sources.  Certain  painkillers,  antimicrobials,  antidepressants, 
contraceptives  and  antiparasitics  are  commonly  found13.  Traces  of  some  pharmaceuticals 
have also been found in drinking water14. 

2.2 

Sources of pharmaceuticals in the environment 

The largest  source of pharmaceuticals  entering the environment  is  use; the route will likely 
differ  depending  upon  whether  human  or  veterinary  use  is  involved.  The  chemical  and/or 
metabolic stability of some pharmaceuticals means that up to 90% of the active ingredient is 
excreted  (or  washed  off)  in  its  original  form.  Wastewater  treatment  varies  in  its  ability  to 
eliminate pharmaceutical residues15, depending upon the substance and the level of treatment; 
in some cases, substantial amounts are removed, in others, only a small percentage; but even 
the best, most expensive, current treatments are not 100% effective. The release of veterinary 
medicines  to  the  environment  tends  to  come  from  untreated  diffuse  sources  such  as  the 
spreading of manure. 
Pharmaceuticals mainly reach the environment through: 

- 

the  discharge  of  effluent  from  urban  waste  water  (sewage)  treatment  plants  – 
containing excreted pharmaceuticals as well as unused pharmaceuticals thrown away 
into sinks and toilets, despite the existence of collection schemes;  

in 

on 

the 

2013 

Study 

11BIO 

Service 

Intelligence 

environment 

environmental 

products. 
the 
https://ec.europa.eu/health/sites/health/files/files/environment/study_environment.pdf;  Report  of  the  2014  Commission  workshop  on 
pharmaceuticals 
and 
http://ec.europa.eu/environment/water/water-dangersub/index.htm#strategic  
12 http://ec.europa.eu/environment/water/water-dangersub/index.htm#strategic  
13 http://ec.europa.eu/environment/water/water-dangersub/index.htm#strategic  
14 http://ec.europa.eu/environment/water/water-drink/pdf/20171215_EC_project_report_final_corrected.pdf  
15  Metabolites  (conversion  products)  may  have  lower  biological  activity  (see  case  studies  in  http://ec.europa.eu/health/human-
use/environment-medicines/index_en.htm)  but  may,  e.g.  if  conjugated,  be  converted  back  to  the  parent  pharmaceutical  during  sewage 
treatment, or have similar biological activity. 

https://circabc.europa.eu/w/browse/5d532921-1e1f-48f5-b0e0-3057798423ca 

medicinal 

risks 

of 

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- 
- 

the spreading of animal manure; and 
aquaculture, in which pharmaceuticals are often dispensed with the animal feed. 

Other sources are: 

- 

- 

the  discharge  of  effluent  from  manufacturing  plants  (especially  those  outside  the 
Union); 
the spreading of sewage sludge, i.e. containing pharmaceuticals removed from waste 
water; 

-  grazing livestock; 
- 
- 

the treatment of pets; 
improper disposal into landfill of unused pharmaceuticals and contaminated waste. 

2.3 

Effects on the environment 

Most pharmaceuticals are designed to act at low concentrations so that they can be tolerated 
by  the  human  or  animal  body,  and  to  last  long  enough  to  have  their  intended  effect. 
Pharmaceuticals  that  persist  in  the  environment  and  spread  through  water  and  soil  or 
accumulate  in  plants  or  wildlife,  as  well  as  pharmaceuticals  whose  environmental 
concentrations  are  steady  because  of  constant  release,  may  pose  a  risk  because  of  their 
toxicity  or  similar  properties.  Studies  have  shown  direct  effects  on  wildlife  from  some 
pharmaceuticals  at  or  even  below  the  low  concentrations  found  in  water  and  soil16.  For 
example, male fish exposed to such concentrations of the main ingredient in the contraceptive 
pill may become feminised as a result of its effects on the endocrine system, thus affecting 
the  capacity  of  the  population  to  reproduce17.  In  other  studies,  fish  exposed  to  low 
concentrations of certain antidepressants have been found to change their behaviour in ways 
that could affect their survival18. The painkiller diclofenac has been found in fish and otters19. 
Alarm was raised several years ago over the unexpectedly lethal effect of this pharmaceutical 
on vultures in Asia, which were exposed to it via the carcasses of cattle treated with it20. A 
decline in populations of dung beetles is thought to be at least partly attributable to the use of 
anti-parasitic pharmaceuticals, including ivermectin21 in livestock. This has consequences for 
nutrient cycling, and other indirect effects on ecosystems including rare bat and bird species 
may also be significant22. 

2.4 

Effects via the environment, including antimicrobial resistance 

As  yet,  no  clear  link  has  been  established  between  pharmaceuticals  present  in  the 
environment  and  direct  impacts  on  human  health.  The  World  Health  Organisation  reports23 
that the weight  of  evidence from  several  recent  studies points to it being very unlikely that 

16 Niemuth NJ and Klaper RD 2015. Chemosphere 135: 38-45; Fent K 2015. Environ Int 84:115-30; Matthiessen P and Sumpter JP 1998. 
EXS. 86:319-35 
17 Kidd KA et al 2007. PNAS 104(21): 8897-8901 
18 Dzieweczynski, TL et al. 2016. J Exp Biol. 219: 797-804 
19 Richards NL et al. 2011. Eur J Wild Res 57(5): 1107-1114 
20 Naidoo V et al. 2009. Regul Toxicol Pharmacol 53(3): 205-8 
21 Verdú JR et al. 2015. Scientific Reports 5: 13912 
22LIFE11 NAT/BE/001060,http://www.lifeprairiesbocageres.eu/fileadmin/Life/Prairies_bocageres/brochure_LPB_antiparasitaires_final.pdf 
23 http://ec.europa.eu/environment/water/water-drink/pdf/20171215_EC_project_report_final_corrected.pdf  

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pharmaceuticals in drinking water pose a threat to human health at the low concentrations24 
found.  However,  it  notes  that  the  issue  of  pharmaceutical  residues  cannot  be  ignored,  and 
refers  to  its  earlier  report25  which  mentions  the  possible  effects  of  long-term  exposure  on 
vulnerable  populations,  hence  the  need  for  a  precautionary  approach,  consistent  with  the 
Commission's proposal to introduce a relevant parameter into the Drinking Water Directive26. 

Several  antimicrobial  (antibiotic  and  antifungal)  pharmaceuticals  from  the  treatment  of 
humans  and  animals  have  been  found  in  water  and  soil:  their  presence  may  play  a  role  in 
accelerating  the  development,  maintenance  and  spread  of  resistant  bacteria  and  fungi.  The 
Commission's  2011  Communication  on  an  Action  Plan  against  the  rising  threats  from 
Antimicrobial Resistance (AMR)27 recognised this. Evidence has grown28, as reflected in the 
revised Action Plan published in 201729. The One Health approach in the Action Plan, which 
had  previously  already  taken  account  of  the  interconnection  between  human  and  animal 
health,  now  also  encompasses  the  environmental  dimension,  recognising  it  as  another  link 
between  diseases  in  humans  and  animals  and  as  a  potential  source  of  new  resistant 
microorganisms.  As  well  as  referring  to  this  Strategic  Approach,  the  Action  Plan  includes 
some additional measures to better address the role of the environment in AMR. 

Of  particular  concern  are  the  indications  that  emissions  from  some  antimicrobial 
manufacturing  plants  in  third  countries30,  some  of  which  supply  products  for  consumption 
also  in  the  Union,  could  be  contributing  to  the  development  and  spread  of  antimicrobial 
resistance at global level.  

2.5  Knowledge gaps  

The  growing  body  of  evidence  regarding  pharmaceuticals  in  the  environment  includes  the 
results of several Union-funded projects31. More information is still needed to understand and 
evaluate  certain  pharmaceuticals  as  regards  their  environmental  concentrations  and  the 
resulting levels  of risk.  One reason is  that many pharmaceuticals  put  on  the market  several 
years ago  were not  subject  to  an environmental  risk assessment as part of the authorisation 
process.  Another  reason  is  that  monitoring  of  pharmaceuticals  in  the  environment  is  very 
limited, although selected substances are monitored in  surface and  ground-waters under the 
Water Framework Directive32,33,34.  

24 Concentrations typically several orders of magnitude lower than the minimum therapeutic dose 
25  http://apps.who.int/iris/bitstream/10665/44630/1/9789241502085_eng.pdf?ua=1  
26 COM (2017) 753 final: Proposal for a Directive of the European Parliament and of the Council on the quality of water intended for human 
consumption (recast) 
27  COM (2011) 748 final: Communication from the Commission to the European Parliament and the Council on an Action Plan Against the 
Rising Threats from Antimicrobial Resistance 
28e.g.  ECDC/EFSA/EMA,  2015.  EFSA  Journal  2015;13(1):4006,  114  pp.  doi:10.2903/j.efsa.2015.4006;  Finley  RL  et  al.  2013.  Clinical 
Infectious Diseases 57(5): 704-710  
29 See footnote 10  
30 Lubbert C et al. 2018. Scientific Reports 45: 479  
31 Knappe, Poseidon, Endetech, Pharmas, Cytothreat, Radar, Demeau, DePharm, Pharm AD, Solutions 
https://cordis.europa.eu/projects/home_en.html 
32 Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action 

in the field of water policy, OJ L327, 22.12.2000, p.1 

33 Commission Implementing Decision (EU) 2018/840 of 5 June 2018 establishing a watch list of substances for Union-wide monitoring in 
the field of water policy pursuant to Directive 2008/105/EC of the European Parliament and of the Council and repealing Commission 
Implementing Decision (EU) 2015/495, OJ L141, 7.6.2018, p.9 

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There  is  also  limited  monitoring  of  "hotspot"  locations,  such  as  those  affected  by  hospital 
effluents.  Even  less  is  known  about  concentrations  in  soils,  and  about  the  presence  of 
antimicrobial  resistant  micro-organisms  and  antimicrobial  resistance  genes.  In  addition, 
possible  "cocktail"  effects  from  the  combined  presence  of  many  pharmaceuticals  and  other 
chemicals in the environment are not well understood. 

It  is  important  to  identify  the  pharmaceuticals  that  pose  a  risk  through  their  individual 
presence  in  the  environment  so  that  risk  management  efforts  can  be  targeted.  For 
pharmaceuticals  already  on  the  market  without  an  environmental  risk  assessment,  an 
industry-led attempt is being made to predict which should be assessed first35.  

Progress has been made, as an environmental risk assessment must now be carried out for all 
pharmaceuticals.  However,  more  timely  availability  of  a  complete  assessment  for  human 
medicinal  products  could  facilitate  the  timely  introduction  of  appropriate  risk  management 
measures. 

2.6  Outlook 

The quantities of pharmaceuticals sold on the European market have grown quickly over the 
past three decades, both in terms of volumes of sales and numbers of active pharmaceutical 
ingredients. More than 3000 active pharmaceutical ingredients are currently on the market.  
According  to  figures  from  the  pharmaceutical  industry36,  the  value  of  sales  of  human 
medicinal  products  in  the  Union  has  risen  very  substantially  since  1990.  Although  due  in 
large  part  to  increases  in  the  price  of  products,  this  rise  also  reflects  a  steady  increase  in 
consumption  per  head  of  the  population37.  Environmental  concentrations  are  likely  to 
increase as the population ages and grows. 

As  regards  sales  of  veterinary  medicinal  products,  data-gathering  has  focussed  on 
antimicrobials used in livestock farming38 because of concerns about antimicrobial resistance. 
Reports  for  nine  countries  from  2005  to  200939,  and  for  30  countries  from  2010  to  201640, 
suggest  that,  overall,  the  quantity  of  antimicrobials  used  has  decreased,  although  not  in  all 
countries. Total tonnage could increase if livestock numbers grow significantly, even if use 
per livestock unit decreases. The figures do not cover other veterinary medicinal products.  

3. 

THE OBJECTIVES OF THE STRATEGIC APPROACH 

The main objectives are to: 

https://www.phar-in.eu/wp-content/uploads/2014/05/Figures_2014_Final.pdf; 

34 Groundwater Watch List: Pharmaceuticals Pilot Study 2016. https://circabc.europa.eu/w/browse/a1e23792-6ecd-4b34-b86c-dcb6f1c7ad1c  
35 http://i-pie.org/  
36 
pharmafigures2018_v07-hq.pdf  
37  OECD  (2019),  "Pharmaceutical  market",  OECD  Health  Statistics  (base  de  données),  https://doi.org/10.1787/data-00545-en  (données 
extraites le 07 January 2019)  
38 https://www.ema.europa.eu/en/veterinary-regulatory/overview/antimicrobial-resistance-veterinary-medicine  
39 https://www.ema.europa.eu/documents/report/trends-sales-veterinary-antimicrobial-agents-nine-european-countries_en.pdf  
40 
eighth-esvac_en.pdf  

https://www.ema.europa.eu/documents/report/sales-veterinary-antimicrobial-agents-30-european-countries-2016-trends-2010-2016-

https://www.efpia.eu/media/361960/efpia-

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- 

- 

- 

- 

identify  actions  to  be  taken  or  further  investigated  to  address  the  potential  risks 
from  pharmaceutical  residues  in  the  environment,  not  least  to  contribute  to  the 
Union's action on combatting antimicrobial resistance; 

encourage innovation where it can help to address the risks, and promote the circular 
economy by facilitating the recycling of resources such as water, sewage sludge and 
manure; 

identify remaining knowledge gaps, and present possible solutions for filling them; 

ensure that actions to address the risk do not jeopardise access to safe and effective 
pharmaceutical treatments for human patients and animals.  

4. 

CURRENT SITUATION: RELEVANT UNION POLICY AND WIDER INITIATIVES 

Union policy 

4.1 
European  Union  legislation  on  medicinal  products41  is  the  primary  means  for  ensuring  the 
quality,  safety  and  efficacy  of  pharmaceuticals  for  use  in  humans  and  animals,  and  their 
safety  for  the  environment.  An  environmental  risk  assessment  is  now  mandatory  for  all 
applications for a marketing authorisation for human and veterinary medicinal products; it is 
taken  into  account  in  the  benefit-risk  assessment  for  the  latter42.  Various  other  pieces  of 
Union  legislation  are  directly  or  indirectly  relevant  to  the  production,  use  or  disposal  of 
pharmaceuticals and their environmental safety43. However, despite the legislation, and partly 
because some of it is only recent, risks to and via the environment remain.  

The  Strategic  Approach  is  complementary  to  the  recently  adopted  Strategy  on  Endocrine 
Disruptors44,  and  linked  to  a  number  of  other  current  and  recent  initiatives,  including 
evaluations  of  the  Urban  Waste  Water  Treatment  Directive  and  other  key  pieces  of  Union 
water  law,  the  proposals  for  a  Regulation  on  water  reuse  and  for  a  recast  of  the  Drinking 
Water Directive, and evaluations of the chemicals legislation. 

It should be noted that pharmaceuticals as products are exempt from most of the provisions 
under  the  Union's  general  chemicals  legislation45,  though  not  from  restriction  provisions46. 
Substances  used  in  the manufacture  of  pharmaceutical  products  are  also  exempt  if  they  are 
present  in  the  final  product.  Those  used  but  not  present  are  subject  to  registration  and 

41 Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and 

repealing Directive 2001/82/EC, OJ L 4, 7.1.2019, p.43, and 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, OJ L 311, 28.11.2001, p.67, as amended. 

42 Regulation (EU) 2019/6 as in previous footnote  
43  BIO Intelligence Service 2013 Study (see footnote 11): Chapter 8  
44  COM(2018)  734  final:  Communication  from  the  Commission  to  the  European  Parliament,  the  Council,  the  European  Economic  And 
Social Committee and the Committee of the Regions: “Towards a comprehensive European Union framework on endocrine disruptors” 
45  Regulation  (EC)  No  1272/2008  of  the  European  Parliament  and  of  the  Council  of  16  December  2008  on  classification,  labelling  and 
packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) 
No  1907/2006,  OJ  L  353,  31.12.2008,  p.1;      Regulation  (EC)  No  1907/2006  of  the  European  Parliament  and  of  the  Council  of  18 
December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals  (REACH), establishing a European 
Chemicals  Agency,  amending  Directive  1999/45/EC  and  repealing  Council  Regulation  (EEC)  No  793/93  and  Commission  Regulation 
(EC)  No  1488/94  as  well  as  Council  Directive  76/769/EEC  and  Commission  Directives  91/155/EEC,  93/67/EEC,  93/105/EC  and 
2000/21/EC, OJ L 396, 30.12.2006, p.1 

46 Restriction provisions in REACH are those which allow the manufacture, use or placing on the market of substances to be made subject to 
conditions  or  be  prohibited  to  address  identified  risks  not  adequately  controlled;  in  practice,  these  provisions  have  not  been  applied in 
relation to medicinal products. 

6 

 
 
                                                           
evaluation provisions under REACH, and can be subject to authorisations and restrictions47. 
A study48 has raised questions about the links between the chemicals and medicinal products 
legislation in relation to environmental protection. 

 Other initiatives 

4.2 
Several Member States (e.g. The Netherlands49, Sweden50), the European Parliament51, third 
countries  (e.g.  Switzerland52),  international  organisations  (e.g.  the  United  Nations53, 
HELCOM54,  Organisation  for  Economic  Cooperation  and  Development55), 
industry 
associations56  and  Non-Governmental  Organisations  have  expressed  concerns  and  taken 
action  to  address  the  growing  presence  of  pharmaceuticals  in  the  environment.  At 
international  level,  both  the  United  Nations  Agenda  2030,  in  particular  Sustainable 
Development  Goal  6,  and  the  2017  United  Nations  Environment  Assembly  ministerial 
declaration, represent commitments to act in this area, and action on antimicrobial resistance 
has been agreed by the G7/G20 and World Health Organisation. 

5 

ACTIONS 

As required by Article 8c of the Priority Substances Directive, this strategic approach should 
be  followed,  where  appropriate,  by  proposals  for  measures  to  be  taken  at  Union  and/or 
Member  State  level  to  address  the  possible  environmental  impacts  of  pharmaceutical 
substances, with a view to reducing discharges, emissions and losses of such substances into 
the aquatic environment, taking into account public health needs and the cost-effectiveness of 
the  measures  proposed.  To  be  effective  and  spread  the  efforts  evenly,  measures  should  not 
only include end-of-pipe controls (e.g. improved waste water treatment) but also address the 
original sources of emissions (e.g. production and use), and consider the terrestrial as well as 
the  aquatic  environment.  This  Communication  sets  out  six  areas  for  action,  and  several 
specific actions relating to possible measures. 

5.1 

Increase awareness and promote prudent use of pharmaceuticals  

Promoting the prudent use of medicinal products which pose a risk to or via the environment, 
including  antimicrobials,  could  significantly  reduce  the  problem  at  source.  Member  States 
and  medical  professionals  have  a  key  role  to  play  in  this  context,  but  the  Commission  can 
play a role by bringing together relevant professionals, contributing to the funding of certain 
training  programmes,  ensuring  that  relevant  legislation  is  adopted,  implemented  and 
enforced, and partnering with international organisations. 

47 Some authorisations have been granted. 
48 http://ec.europa.eu/environment/chemicals/reach/pdf/studies_review2012/report_study8.pdf 
49 The Netherlands Chain approach to reduce pharmaceutical residues in water. 2018. Abstract for OECD workshop on contaminants.  
50 https://www.fass.se/LIF/  
51 E.g. EP Intergroup CCBSD event 29 November 2017 http://ebcd.org/event/pharmaceuticals-in-the-environment/  
52 https://www.parlament.ch/centers/eparl/curia/2012/20123090/Bericht%20BR%20D.pdf 
53 SAICM http://www.saicm.org/EmergingPolicyIssues/Pharmaceuticalnbsp;Pollutants/tabid/5477/language/en-US/Default.aspx  
54 The Baltic Marine Environment Protection Commission: http://www.helcom.fi/news/Pages/Pharmaceuticals-in-Baltic-waters--new-status-

report-by-UNESCO-and-HELCOM.aspx  

55 http://www.oecd.org/water/oecdworkshoponmanagingcontaminantsofemergingconcerninsurfacewaters.htm  
56  Eco-pharmaco-stewardship 

https://www.efpia.eu/media/25628/eps-a-holistic-environmental-risk-management-program.pdf 

and 

https://www.efpia.eu/media/288586/pie-brochure.pdf  

7 

 
 
 
 
                                                           
 
The Commission will: 

•  Promote  the  development  of  guidelines  for  healthcare  professionals  on  the 

prudent use of pharmaceuticals posing a risk to or via the environment; 

•  Explore, in cooperation with relevant stakeholders, how environmental aspects 
could  become  part  of  medical  training  and  professional  development 
programmes; 

•  Aim to limit the preventive use of veterinary antimicrobials by ensuring correct 
implementation  of  the  newly  adopted  Regulation  on  veterinary  medicinal 
products57; 

•  Foster best-practice exchanges between Member States on how environmental 
considerations  are  taken  into  account  in  the  advertising  and  prescription  of 
medicinal  products  and  the  choice  of  therapy  more  generally,  where 
appropriate;  

•  Strengthen  cooperation  with  the  World  Health  Organisation  and  other  key 
international organisations on activities to raise awareness of the issue and find 
solutions, including by the sharing of best practices. 

5.2 

Support the  development  of pharmaceuticals  intrinsically less harmful  for the 
environment and promote greener manufacturing 

The pharmaceutical industry needs to be encouraged to take the environment, from a lifecycle 
perspective,  more  into  account  through  the  design  and  manufacturing  stages.  Since  the 
industry  acts  at  global  level  and  its  actions  can  have  global  reach,  it  makes  sense  for  the 
Union to  ensure a level  playing field  as regards  environmental and health protection across 
the Union, and to stimulate responsible behaviour also outside the Union.  

The Commission will: 

•  Subject to adequate availability of funds following final agreement with the co-
legislators on the next  Multi-annual  Financial Framework, fund research and 
innovation  to  support  the  development  of  “greener”  pharmaceuticals  that 
degrade more readily, to harmless substances, in waste water treatment plants 
and the environment; 

•  Engage directly with the pharmaceutical industry on its potential contribution 
to  meeting  the objectives of the approach, among other things to explore how 
extended  producer  responsibility  could  play  a  role  in  supporting  action  to 
improve the efficacy of water treatment; 

•  Under the Water Framework Directive, consider specific pharmaceuticals, and 
groups  of  pharmaceuticals  with  similar  effects,  in  the  work  supporting  the 
regular review of the list of substances posing a risk at Union level, and work 

57   Regulation  (EU)  2019/6  of  the  European  Parliament  and  of  the  Council  of  11 December  2018  on  veterinary  medicinal  products  and 
repealing Directive 2001/82/EC, OJ L 4, 7.1.2019, p.43 

8 

 
 
 
                                                           
 
with  Member  States  on  environmental  quality  standards  for  pharmaceuticals 
posing a risk at national  level;  

•  Ensure  that  the  emission  of  pharmaceuticals  to  water  is  considered  as  a 
possible  Key  Environmental  Issue  when  reviewing  Best  Available  Techniques 
Reference  Documents  under  the  Industrial  Emissions  Directive  for  relevant 
sectors; 

•  Discuss,  with  the  relevant  Member  State  authorities,  the  possibility  of  using 
procurement  policy  to  encourage  greener  pharmaceutical  design  and 
manufacturing; 

•  Encourage, through dialogue and cooperation, as part of the Union’s external 
policies,  action  in  third  countries  where  pharmaceutical  emissions  from 
manufacturing  and  other  sources  are  suspected  of  contributing  to  the  global 
spread of AMR. 

5.3 

Improve environmental risk assessment and its review 

It’s important that risk assessment and guidance development are coordinated and involve all 
relevant  expertise.  Data  sharing  and  improved  access  to  data  could  facilitate  better  risk 
management,  as  could  retrospective  environmental  risk  assessment  for  several  products 
already  on  the  market,  and  earlier  availability  of  the  risk  assessment  data  for  human 
medicinal products. The initiative in all these areas can best be taken at Union level. 

The Commission will: 

• 

In collaboration with the European Medicines Agency and Member States: 

-  Seek to improve the level of environmental expertise in the Committees and 
networks  involved  in  the  environmental  risk  assessment  of  medicinal 
products; 

-  Consider  developing  guidance  on  the  environmental  risk  assessment  of 
medicinal  products  for  use  in  aquaculture  including,  where  appropriate, 
recommendations for risk management measures; 

-  Examine  how  to  improve  public  access  to  the  main  environmental  risk 
assessment  results  and  relevant  toxicological  thresholds  for  medicinal 
products while respecting data-protection rules; 

-  Emphasise  to  applicants  the  importance  of  submitting  a  completed 
assessment by the time of the authorisation for marketing human medicinal 
products,  so  that  adequate  risk  management  measures  can  be  established 
and published; 

•  Pursuant  to  the  newly  adopted  Regulation   on  veterinary  medicinal  products, 
report on the feasibility of setting up an EU-wide review system based on active 
pharmaceutical  ingredients,  or  similar,  to  support  the  environmental  risk 
assessment of veterinary medicinal products at Union level;  

• 

Initiate  a systematic catching-up procedure for veterinary  medicinal  products 
without  an  (adequate)  environmental  risk  assessment,  as  provided  for  in  the 

9 

 
 
 
Regulation  on  veterinary  medicinal  products,  and  take  stock  of  the  results  of 
research  under  the  Innovative  Medicines  Initiative58  in  relation  to  human 
medicinal products; 

•  Consider  the  findings  of  recent  REACH  evaluations  and  the  ongoing  Fitness 
Check of other Union chemicals legislation as regards links with the medicinal 
products legislation in relation to environmental protection. 

5.4 

Reduce wastage and improve the management of waste  

Less  wastage  of  pharmaceuticals  and  proper  disposal  would  reduce  the  risk  to  the 
environment. More advanced waste water treatment technology may be appropriate at some 
locations. Source control of the diffuse emissions from livestock farming appears particularly 
necessary.  

The Commission will: 

• 

In collaboration with Member States and the European Medicines Agency: 

- 

- 

explore the possibility of reducing waste by optimising the package  size of 
pharmaceuticals  so  that  medicines  can  be  dispensed  in  quantities  better 
matching needs, and by safely extending use-by (expiry) dates so that fewer 
medicines that are still usable have to be thrown away; 

facilitate the exchange of best practices  among healthcare professionals  on 
the environmentally safe disposal of medicinal products and clinical waste, 
and the collection of pharmaceutical residues as appropriate ;  

•  Assess  the  implementation  of  collection  schemes  for  unused  pharmaceuticals 
and consider how their availability and functioning could be improved, how to 
increase public awareness of the importance of using them, and how extended 
producer responsibility could play a role in reducing inappropriate disposal; 

• 

In relation to urban waste water treatment: 

-  Use Union programmes to invest in technologies to improve the efficiency of 

removal of pharmaceuticals (and antimicrobial resistance genes); 

treatment 

-  As part of the study supporting  the evaluation of the existing urban waste 
water 
it  sufficiently  controls 
pharmaceutical  emissions  and  investigate  the  feasibility  of  upgrading 
selected  urban  waste  water  treatment  plants  to  more  advanced  treatment 
technologies;  

legislation,  assess  whether 

•  Assess the possibility of working with Member States on improving their Codes 
of  Good  Agricultural  Practice  to  cover  also  the  management  of  contaminants 
including pharmaceuticals in livestock manure; 

•  When  the  Industrial  Emissions  Directive  is  next  evaluated,  assess  whether  it 

58  For  example  as  regards  the  potential  application  of  relevant  prioritisation  principles  identified  in  the  ongoing  Innovative  Medicines 
Initiative project on Intelligence-led Assessment of Pharmaceuticals in the Environment (http://i-pie.org/), due to be completed by the end of 
2019. 

10 

 
 
 
                                                           
should address intensive dairy farming59. 

5.5 

Expand environmental monitoring 

The  collection  and  management  of  environmental  data  is  to  a  large  extent  based  on  Union 
legislation  and/or  supported  by  Union  funding.  Knowing  more  about  the  concentrations  of 
pharmaceuticals  in  the  environment  would  allow  environmental  risk  assessments  to  be 
improved  and  measures  to  be  more  focused,  especially  if  monitoring  could  be  extended  to 
better  cover  certain  parts  of  the  environment,  where  necessary  involving  cooperation  with 
stakeholders.  

The Commission will: 

•  Consider  additional  potentially  relevant  pharmaceuticals,  such  as  cytotoxic 
pharmaceuticals and X-ray contrast media, in the work supporting the review 
of the surface water Watch List under the Water Framework Directive, as well 
as  the  feasibility  of  monitoring  antimicrobial  resistant  microorganisms  and 
antimicrobial resistance genes; 

•  Support  research  on  monitoring  individual  substances  and  mixtures  of 
substances  in  fresh  and  marine  waters,  soils,  sediments,  and  wildlife,  using 
conventional analytical and complementary techniques; 

•  Explore  with  stakeholders,  including  water  treatment  companies/authorities, 
the  gathering  of  relevant  data  in  effluents  from  potential  hotspots;  the 
development of online monitoring, and the sharing of data via the Information 
Platform  for  Chemical  Monitoring60,  to  inform  analyses  of  sources  and 
potential exposure; 

• 

Include antimicrobials and possibly antimicrobial resistance genes in the next 
phase of the European Commission’s LUCAS soil survey61. 

5.6 

Fill other knowledge gaps 

While the above actions include some research, our ability to manage the risk could benefit 
from research in other areas.  

The Commission will thus consider supporting further research, also under the Union's next 
Multi-annual Financial Framework, into:  

•  The eco-toxicity and environmental fate of pharmaceuticals, in particular those 

not yet subject to environmental risk assessment; 

•  The links between the presence of antimicrobials in the environment (if possible 
also the entry and natural presence of antimicrobial resistance genes) and the 

59 At present, only intensive pig and poultry farming are covered (http://eippcb.jrc.ec.europa.eu/reference/irpp.html). 
60 https://ipchem.jrc.ec.europa.eu/RDSIdiscovery/ipchem/index.html  
61 https://esdac.jrc.ec.europa.eu/projects/lucas  

11 

 
 
 
 
                                                           
development and spread of antimicrobial resistance;  

•  The  possible  effects  on  humans  of  (chronic)  exposure  to  low  levels  of 
pharmaceuticals  via  the  environment,  taking  account  of  the  potential  for 
combined effects from multiple substances, and of vulnerable sub-populations;  

•  Cost-effective methods for reducing the presence of pharmaceuticals including 
antimicrobials  in slurry,  manure and sewage  sludge to enable their  use in the 
circular economy. 

6 

CONCLUSIONS 

This  Communication  sets  out  a  strategic  approach  to  the  risks  from  pharmaceuticals  in  the 
environment,  and  thus  meets  a  legal  obligation  to  propose  an  approach  addressing  the 
pollution  of  water  by  pharmaceuticals.  It  also  contributes  to  tackling  the  problem  of 
antimicrobial  resistance  and  honours  commitments  made  at  international  level,  where,  as  a 
strong global actor, the Union can encourage wide cooperation. 

Although  it  is  clear  that  treating  many  diseases  in  animals  and  humans  relies  on  effective 
pharmaceuticals,  and  that  some  substantial  knowledge  gaps  remain  to  be  filled,  there  is 
sufficient evidence that action should be taken to reduce the risk from pharmaceuticals in the 
environment. This requires the involvement of all relevant stakeholders along the entire life 
cycle,  including  Member  State  competent  authorities,  the  pharmaceutical  industry,  medical 
and veterinary professionals, patients, farmers and the water industry, with the shared goal of 
building a more sustainable, resource-efficient and circular economy. 

While leading on actions within its area of competence, the Commission will also encourage 
others to lead, including by facilitating the exchange of best practices.  

The Communication focuses on actions that are starting, will be initiated and, in some cases, 
completed by 2020.  

The  Commission  will then  take  stock  of  progress  made  and  decide  on  further  steps,  taking 
into  account  the  outcomes  of  ongoing  evaluations  of  the  water  legislation  and  relevant 
research. 

12