Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union
Date: 2012-10-04
Institutions: European Commission
Subjects: access to information, administrative check, catalogue, exploitation of resources, genetics, profit sharing, research results, scientific cooperation

EUROPEAN 
COMMISSION 

Brussels, 4.10.2012  
COM(2012) 576 final 

2012/0278 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising 
from their Utilization in the Union 

(Text with EEA relevance) 

{SWD(2012) 291 final} 
{SWD(2012) 292 final} 

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EXPLANATORY MEMORANDUM 

1. 

• 

CONTEXT OF THE PROPOSAL 

Grounds for and objectives of the proposal 

The  main  objective  of  the  proposal  for  a  Regulation  of  the  European  Parliament  and  of  the 
Council  on  Access  to  Genetic  Resources  and  the  Fair  and  Equitable  Sharing  of  Benefits 
Arising from their Utilization in the Union is to implement the Nagoya Protocol in the Union 
and to enable Union ratification of this treaty. 

• 

General context 

Genetic resources - the gene pool in both natural and cultivated stocks - play a significant and 
growing role in many economic sectors: 26% of all new approved drugs over the last 30 years 
are either natural products or have been derived from a natural product.1  

A broad range of players in the Union, including academic researchers and companies from 
different sectors  of  industry  (for example, plant and animal breeding, biocontrol, cosmetics, 
food  and  beverage,  horticulture,  industrial  biotechnology,  pharmaceutical)  use  genetic 
resources  for  research  and  development  purposes,  some  also  use  traditional  knowledge 
associated with genetic resources. 

The  European  Union  and  all  of  its  27  Member  States  are  Parties  to  the  Convention  on 
Biological  Diversity2  (CBD).  The  CBD  recognizes  that  states  have  sovereign  rights  over 
genetic resources found within their jurisdiction and the authority to determine access to such 
resources.  The  Convention  obliges  all  Parties  to  facilitate  access  to  genetic  resources  over 
which they hold sovereign rights. It also obliges all Parties to share in a fair and equitable way 
the  results  of  research  and  development  and  the  benefits  arising  from  the  commercial  and 
other utilization of genetic resources with the Party providing these resources.  

The CBD also addresses the rights of indigenous and local communities that hold traditional 
knowledge  associated  with  genetic  resources,  and  which  may  provide  important  lead 
information for the scientific discovery of interesting genetic or biochemical properties. 

However, the CBD currently provides little detail on how access and benefit-sharing (ABS) 
for  the  use  of  genetic  resources  and  associated  traditional  knowledge  should  be  done  in 
practice.  Actors  at  the  beginning  of  the  genetic  resources  value  chain  in  the  Union  (mostly 
collections  and  academic  researchers)  are  in  direct  contact  with  the  laws  and  authorities  of 
provider countries. These first actors pass on samples of genetic resources and first research 
results to other users that engage in basic or applied research. Actors situated at the end of the 
genetic  resources  engage  in  often  lengthy  development  activities  that  require  significant 
investments  with  uncertain  outcomes.  They  largely  depend  on  material  and  information 
passed on to them from earlier users in the chain, including in relation to ABS. In the absence 
of clear rules or with very burdensome rules in most provider countries, European researchers 

1 

2 

Newman and Cragg (2012), "Natural Products as Sources of New Drugs over the 30 Years from 1981 
to 2010". Journal of Natural Products, 75(3), pp 311–335. 
Convention  on  Biological  Diversity  (Rio  de  Janeiro,  5  June  1992,  in  force  29  December  1993), 
available at <http://www.cbd.int/convention/text/>. 

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and companies have repeatedly been accused of 'biopiracy' by countries claiming a violation 
of their sovereign rights. A clear framework of obligations for all users of genetic resources 
throughout the value chain is essential for creating an enabling context for facilitated access to 
quality samples of genetic resources with high legal certainty. 

The "Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of 
Benefits  Arising  from  Their  Utilization  to  the  Convention  on  Biological  Diversity" 
(hereinafter: Nagoya Protocol) is a new international treaty adopted on 29 October 2010 by 
the  consensus  of  the  193  Parties  to  the  CBD.  It  is  a  treaty  with  legally  binding  effects  that 
significantly  expands  the  general  ABS  framework  of  the  CBD.  The  Nagoya  Protocol  is 
expected  to  enter  into  force  in  2014.  Once  operational,  the  Nagoya  Protocol  will  generate 
significant  benefits  for  biodiversity  conservation  in  States  that  make  available  the  genetic 
resources over which they hold sovereign rights. It will in particular: 

– 

– 

– 

Establish more predictable conditions for access to genetic resources. 

Ensure benefit-sharing between users and providers of genetic resources. 

Ensure that only legally acquired genetic resources are used. 

The  Protocol  rests  on  two  main  pillars:  measures  on  access,  and  measures  on  user-
compliance. 

The access pillar leaves Parties discretion whether they wish to regulate access, and require 
prior  informed  consent  and  benefit-sharing  for  the  use  of  their  genetic  resources  or  not. 
However, if a Party decides to do so, then it must implement the fairly detailed "international 
access standards" set out in the treaty through binding legislation. The Protocol also clarifies 
that states must engage with their indigenous and local communities in case access is sought 
to  traditional  knowledge  or  to  genetic  resources  held  by  these  communities.  Main  Protocol 
principles 
indigenous 
representatives  must  give  their  prior  informed  consent  before  access  can  take  place,  (ii) 
specific  benefit-sharing  obligations  must  be  set  out  in  private  law  contracts  between  a 
provider and a user, and (iii) access frameworks must be clear and transparent, based on non-
arbitrary rules, and result in reliable and timely decisions, in a cost-effective manner.  

include:  (i)  government  authorities  or 

in  relation 

to  access 

The user-compliance pillar of the Protocol obliges all Parties to the Protocol to take measures 
to provide that only legally acquired genetic resources and associated traditional knowledge 
are utilized within their jurisdiction. Parties must monitor the compliance of users within their 
jurisdiction  and  designate  one  or  more  checkpoints  for  this  task.  They  must  also  take 
appropriate,  effective  and  proportionate  measures  in  cases  where  users  within  their 
jurisdiction  do  not  comply  with  their  ABS-related  obligations.  Parties  must  also  ensure  that 
disputes  arising  from  specific  benefit-sharing  contracts  can  be  taken  to  court.  However, 
different  than  in  the  case  of  access,  the  user-compliance  provisions  of  the  Nagoya  Protocol 
leave Parties quite some discretion on the type and mix of implementing measures chosen. 

Parties  to  the  Protocol  will  need  to  make  further  choices  on  the  temporal  application  of 
implementing measures, on the respect for existing specialised ABS instruments3, and apply 

3 

For example, the International Treaty on Plant Genetic Resources for Food and Agriculture concluded 
in 2001 in the context of the UN Food and Agriculture Organization and to which the EU is a Party. For 
details see Annex 1. 

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special considerations to non-commercial research, to the exchange of genetic resources with 
pathogenic properties, and to genetic resources for food and agriculture. They will also need 
to  address  the  relations  with  non-Parties  to  the  Protocol.  All  Parties  to  the  Protocol  must 
furthermore  establish  a  National  Focal  Point  on  ABS  to  liaise  with  the  international 
Secretariat and to respond to information requests by stakeholders. Parties must also designate 
one or more Competent National Authorities responsible for granting access and advising on 
applicable procedures for requiring prior informed consent and entering into mutually agreed 
terms.  Parties  may  designate  a  single  entity  to  fulfill  the  functions  of  both  focal  points  and 
competent national authority. 

The  Union  and  most  of  its  Member  States4  have  signed  the  Nagoya  Protocol  and  thereby 
committed 
ratification.  Union 
implementation and ratification of the Protocol will create new opportunities for nature-based 
research, and contribute to the development of a bio-based economy.5 

implementation  and 

themselves 

to  work 

towards 

• 

Existing provisions in the area of the proposal 

Neither the implementation of the access nor of the user-compliance pillar of the Protocol is 
currently addressed in Union-law. 

• 

Consistency with the other policies and objectives of the Union 

The EU and its Member States are politically committed to become Parties to the Protocol to 
secure access of EU researchers and companies to quality samples of genetic resources, based 
on reliable access decisions at low transaction costs.6 

The proposal is also consistent with the EU's signature of the Protocol and also with target 16 
of the CBD's Strategic Plan which foresees that by 2015 the Nagoya Protocol is in force and 
operational, consistent with national legislation. 

2. 

RESULTS  OF  CONSULTATIONS  WITH  INTERESTED  PARTIES  AND 
IMPACT ASSESSMENT 

This  initiative  is  the  result  of  extensive  consultations  with  the  general  public  and  relevant 
stakeholders. Furthermore, the Commission carried out an impact assessment of the proposed 
policy options which led to the publication of a report. 

• 

Public consultation 

The Commission held a web-based public consultation from 24 October to 30 December 2011 
to  seek  feedback  on  a  list  of  questions  that  addressed  key  aspects  of  Nagoya  Protocol 
implementation. Forthy-three replies were received that represented a much broader number 
of respondents, since the majority of replies came from European or international associations 
with  hundreds  or  thousands  of  members  each.  The  respondents  covered  most  sectors 
potentially  affected  by  implementation  measures  under  the  Nagoya  Protocol.  The  list  of 

4 
5 
6 

Latvia, Malta and Slovakia have not yet signed. 
See Commission Communication on a Bioeconomy for Europe (COM (2012) 60 final). 
See  Council  Conclusions  of 20  December 2010 (paragraphs 1  and 21), 23 June 2011 (paragraph 14), 
European Parliament Resolution of 20 April 2012 (paragraph 101), Commission Communication on an 
EU Biodiversity Strategy to 2020 (COM (2011) 244) (Action 20). 

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questions together with the results of the web-based public consultation have been published 
link: 
the  European  Commission 
in 
http://ec.europa.eu/environment/consultations/abs_en.htm. 

the  website 

following 

under 

the 

of 

• 

Ad hoc consultations 

DG Environment organised a technical meeting on 26 January 2012 including all respondents 
to  the  public  consultation,  Brussels-based  representatives  of  stakeholders,  and  experts 
nominated by Member States. At the meeting, the Commission presented its summary of the 
public consultation, whereas members of the consultant team presented tentative findings of 
their work. Participants used the opportunity to challenge the consultant team on some of their 
findings. 

DG  Environment  officials  held  many  meetings  with  representatives  of  botanical  gardens, 
culture  collections,  industry  federations  or  individual  companies  and  participated  in  various 
expert  conferences  on  the  Nagoya  Protocol.  The  consultant  team  conducted  semi-structured 
interviews with representatives of stakeholders and companies.  

• 

Consultations with third countries 

In 2011, DG Environment asked several EU delegations in third countries to seek information 
from major partner countries on the state of play and their concrete ideas for Nagoya Protocol 
implementation.  The  feedback  received  was  complemented  by  more  detailed  bilateral 
discussions with Australia, Brazil, India, Japan, Mexico and Switzerland. 

• 

Impact Assessment Report  

In line with its "Better Regulation" policy, the Commission has conducted an assessment of 
the economic, social and environmental impacts of different policy options for implementing 
the Nagoya Protocol. This report is accessible on the web site of the European Commission 
(DG Environment). The Commission also contracted a consultancy firm to carry out a study 
as an input for its report. This study is accessible at the same web site. 

The Commission's impact assessment considered a broad range of options for implementing 
the Nagoya Protocol. Two options for access measures and four options for user-compliance 
measures  were  analyzed  in-depth.  All  options  were  analyzed  against  a  business  as  usual 
baseline without implementing measures at EU or Member State level. It also analyzed two 
options  on  the  temporal  application  of  EU-level  measures  as  well  as  a  range  of 
complementary measures. 

The analysis identified the establishment of an EU platform for discussing access to genetic 
resources and sharing best practices as the preferable option on access, whereas the identified 
preferable option on user-compliance is a due diligence obligation on EU users complemented 
by a system to identify collections as "trusted sources" of genetic resources. The due diligence 
obligation would only apply to genetic resources and associated traditional knowledge that are 
acquired  after  the  entry  into  force  of  the  Nagoya  Protocol  for  the  EU.  To  lower  costs  and 
enhance  effectiveness,  these  measures  should  be  complemented  by  awareness  and  training 
activities,  work  on  contractual  model  clauses,  work  on  technical  tools  for  monitoring  and 
tracking  genetic  resources  flow,  and  where  appropriate  through  bilateral  cooperation  with 
other countries or regions. 

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The  due  diligence  obligation  would  ensure  that  minimum  information  relevant  to  ABS  is 
available all throughout the genetic resources value chain in the Union. This will enable all 
users  to  know  of  and  respect  related  rights  and  obligations.  At  the  same  time,  the  due 
diligence approach does not prescribe the same type of measures to all users, but leaves users 
some  flexibility  to  take  measures  that  work  best  for  their  respective  context,  and  also  to 
develop sectoral best practices. The system of trusted sources would substantially lower the 
risk  that  illegally  acquired  genetic  resources  are  used  in  the  Union.  Acquiring  samples  for 
trusted sources would seem particularly beneficial for academic researchers as well as small 
and medium sized enterprises. 

3. 

• 

LEGAL ELEMENTS OF THE PROPOSAL 

Summary of the proposed action 

The  proposal  sets  out  obligations  for  users  of  genetic  resources  and  traditional  knowledge 
associated  with  genetic  resources  in  the  Union.  It  would  oblige  all  users  to  exercise  due 
diligence to ascertain that genetic resources and traditional knowledge associated with genetic 
resources  used  were  accessed  in  accordance  with  applicable  legal  requirements  and  that, 
where relevant, benefits are fairly and equitable shared upon mutually agreed terms. To that 
end, all users would need to seek, keep and transfer to subsequent users certain information 
relevant  for  access  and  benefit-sharing.  The  proposal  sets  out  minimum  features  of  due 
diligence measures.  

To comply, users could build on existing ABS codes of conduct developed for the academic 
sector  and  different  industries.  Associations  of  users  may  request  the  Commission  to 
recognise  a  specific  combination  of  procedures,  tools  or  mechanisms  overseen  by  an 
association as best practice. Competent authorities of the Member States would be obliged to 
consider  that  the  implementation  of  a  recognised  best  practice  by  a  user  reduces  that  user's 
risk of non-compliance and justifies a reduction in compliance checks. 

This  proposal  also  foresees  a  system  of  Union  trusted  collections  that  would  substantially 
lower the risk that illegally acquired genetic resources are used in the Union. Collections that 
wish to be included in the register of Union trusted collection would commit to supply only 
fully documented samples of genetic resources to third persons for their use. The competent 
authorities of the Member States will have to verify if a collection meets the requirements for 
recognition as Union trusted collection. Users acquiring a genetic resource from a collection 
included in the Union register would be considered to have exercised due diligence as regards 
the  seeking  of  all  necessary  information.  A  system  of  Union  trusted  collections  will  be 
particularly  beneficial  for  academic  researchers  as  well  as  small  and  medium  sized 
enterprises. 

Users  would  be  obliged  to  declare  at  identified  points  that  they  complied  with  their  due 
diligence  obligation.  Competent  authorities  of  Member  States  should  check  on  a  risk-based 
approach whether users comply with their obligations under this Regulation. Member States 
should also ensure that infringements of this Regulation by users are sanctioned by effective, 
proportionate and dissuasive penalties. 

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Finally, the proposed Regulation also foresees the creation of a Union platform on access. 

• 

Legal basis 

The proposal is based on the Union's environment policy competence in Article 192(1) of the 
Treaty  on  the  Functioning  of  the  European  Union  as  it  aims  at  implementing  the  Nagoya 
Protocol, a global environmental agreement in favour of the conservation and sustainable use 
of biological diversity worldwide. 

• 

Choice of instrument 

The proposed instrument is a regulation because a regulation is necessary in order to ensure 
the highest level  of  harmonization and avoid the coexistence of different standards between 
Member States. 

• 

The principles of subsidiarity and proportionality 

The  proposal  would  comprehensively  implement  the  user-compliance  pillar  of  the  Nagoya 
Protocol.  Member  States  would  have  discretion  whether  or  not  to  require  prior  informed 
consent and benefit-sharing for genetic resources that belong to them. Their decisions on this 
would not be a precondition for Union ratification of the Nagoya Protocol. 

Only  two  Member  States  of  the  Union  have  so  far  developed  legislation  on  access  to  their 
genetic resources over which they hold sovereign rights, whereas other Member States have 
decided  to  grant  free  access  to  their  genetic  resources.  Presently  EU-harmonised  access 
measures are not needed. In case a Member State decides to require prior informed consent 
and benefit-sharing it would have to implement the access-related provisions of the Nagoya 
Protocol.  The  proposed  Union  platform  on  access  would  be  a  non-binding  approach  for 
streamlining access conditions in Member States based on the method of open coordination. 

A legally binding EU-level intervention on user-compliance is justified as it avoids negative 
effects on the internal market in nature-based products and services that would result from a 
fragmentation  of  user-compliance  systems  in  the  Member  States  and  also  has  the  best 
performance as regards the creation of an enabling context for research and development on 
genetic resources with benefits for the conservation and sustainable use of biological diversity 
worldwide. 

The  proposed  due  diligence  obligation  on  users  of  genetic  resources  and  traditional 
knowledge  associated  with  genetic  resources  is  also  proportionate  as  it  would  balance  the 
objectives  of  minimising  the  risks  of  the  use  of  illegally  acquired  genetic  resources  in  the 
Union and of supporting the fair and equitable sharing of  benefits resulting  from  the use of 
genetic  resources  or  traditional  knowledge  associated  with  genetic  resources  upon  mutually 
agreed terms with considerations on legal certainty, low transaction costs, and the flexibility 
inherent  in  the  due  diligence  concept  to  take  implementing  measures  that  are  best  suited  to 
different circumstances. 

4. 

BUDGETARY IMPLICATION 

The present proposal does not entail any significant financial implications for the Community 
budget. 

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5. 

EUROPEAN ECONOMIC AREA (EEA) 

The proposal concerns an EEA matter and should therefore extent to the European Economic 
Area. 

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2012/0278 (COD) 

Proposal for a 

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising 
from their Utilization in the Union 

(Text with EEA relevance) 

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  on  the  Functioning  of  the  European  Union,  and  in  particular 
Article 192(1) thereof, 

Having regard to the proposal from the European Commission, 

After transmission of the draft legislative act to the national Parliaments, 

Having regard to the opinion of the European Economic and Social Committee7, 

Having regard to the opinion of the Committee of the Regions8, 

Acting in accordance with the ordinary legislative procedure, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

A broad range of players in the Union, including academic researchers and companies 
from different sectors of industry, use genetic resources for research, development and 
commercialisation  purposes;  some  also  use  traditional  knowledge  associated  with 
genetic resources. 

Genetic  resources  represent  the  gene  pool  in  both  natural  and  cultivated  or 
domesticated stocks and play a significant and growing role in many economic sectors 
including food production, forestry, development of medicines, or development of bio-
based sources of renewable energy.  

Traditional knowledge that is held by indigenous and local communities may provide 
important  lead  information  for  the  scientific  discovery  of  interesting  genetic  or 
biochemical properties of genetic resources. 

The main international instrument governing access to and use of genetic resources is 
the  Convention  on  Biological  Diversity  (the  Convention).  Council  Decision 

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8 

OJ C , , p. . 
OJ C , , p. . 

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(5) 

(6) 

(7) 

(8) 

(9) 

93/626/EEC of 25 October 1993 concerning the Convention on Biological Diversity9 
approved the Convention on behalf of the Union. 

The  Convention  recognises  that  states  have  sovereign  rights  over  natural  resources 
found  within  their  jurisdiction  and  the  authority  to  determine  access  to  their  genetic 
resources. The Convention imposes an obligation on all Parties to facilitate access to 
genetic resources over which they hold sovereign rights. It also makes it mandatory for 
all Parties to take measures to share in a fair and equitable way the results of research 
and development and the benefits arising from the commercial and other utilization of 
genetic resources with the Party providing these resources. Such sharing shall be upon 
mutually  agreed  terms.  The  Convention  also  addresses  access  and  benefit-sharing  in 
relation  to  the  knowledge,  innovations  and  practices  of  indigenous  and  local 
communities relevant for the conservation and sustainable use of biological diversity. 

The  Nagoya  Protocol  on  Access  to  Genetic  Resources  and  the  Fair  and  Equitable 
Sharing  of  Benefits  Arising  from  Their  Utilization  to  the  Convention  on  Biological 
Diversity (the Nagoya Protocol) is an international treaty adopted on 29 October 2010 
by  the  Parties  to  the  Convention10.  The  Nagoya  Protocol  significantly  expands  the 
general  rules  of  the  Convention  on  access  and  benefit-sharing  for  the  use  of  genetic 
resources and traditional knowledge associated with genetic resources. 

Council Decision xxxx/xx/EU of [date] on the conclusion of the Nagoya Protocol on 
Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising 
from  their  Utilization  to  the  Convention  on  Biological  Diversity11  approved  the 
Nagoya Protocol on behalf of the Union. 

It is important to set out a clear and sound framework for implementing the Nagoya 
Protocol  that  should  enhance  opportunities  available  for  nature-based  research  and 
development activities in the Union. It is also essential to prevent the use of illegally 
acquired genetic resources or traditional knowledge associated with genetic resources 
in  the  Union  and  to  support  the  effective  implementation  of  benefit-sharing 
commitments set out in mutually agreed terms between providers and users. 

In  order  to  ensure  legal  certainty,  it  is  important  that  the  rules  implementing  the 
Nagoya  Protocol  should  only  apply  to  genetic  resources  and  traditional  knowledge 
associated  with  genetic  resources  that  are  accessed  after  the  entry  into  force  of  the 
Nagoya Protocol for the Union.  

(10)  Council  Decision  2004/869/EC  of  24  February  2004  concerning  the  conclusion,  on 
behalf  of  the  European  Community,  of  the  International  Treaty  on  Plant  Genetic 
Resources for Food and Agriculture International Treaty on Plant Genetic Resources 
for Food and Agriculture12
 approved that Treaty on behalf of the Union. That Treaty 
constitutes  a  specialized  international  access  and  benefit-sharing  instrument  that 
should not be affected by the rules implementing the Nagoya Protocol. 

9 
10 
11 
12 

OJ L 309, 13.12.19993, p. 1. 
Annex I to Document UNEP/CBD/COP/DEC/X/1 of 29 October 2010.. 
OJ 
OJ L 378, 23.12.2004, p. 1. 

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(11) 

It is important to define, in accordance with the Nagoya Protocol, that use of genetic 
resources  refers  to  research  and  development  on  the  genetic  or  biochemical 
composition of samples of genetic material, which includes research and development 
on isolated compounds extracted from genetic material that was accessed in a Party to 
the Nagoya Protocol. 

(12) 

It seems important to recall CBD Decision II/11 paragraph.2 – as confirmed by CBD 
Decision X/1, paragraph 5 – that reaffirms the exclusion of human genetic resources 
from the framework of the Convention. 

(13)  There  is  currently  no  internationally  agreed  definition  on  "traditional  knowledge 
associated with genetic resources" or on "holding" such knowledge by an indigenous 
and local community. International definitions of those terms and concepts are being 
negotiated  in  the  Intergovernmental  Committee  of  the  World  Intellectual  Property 
Organization. Therefore, in order to ensure flexibility and legal certainty for providers 
and users, this Regulation should make reference to traditional knowledge associated 
with genetic resources as described in benefit-sharing agreements. 

(14)  With a view to ensuring an effective implementation of the Nagoya Protocol, all users 
of genetic resources and traditional knowledge associated with such resources should 
have  to  exercise  due  diligence  to  ascertain  that  the  genetic  resources  and  associated 
traditional  knowledge  used  were  accessed  in  accordance  with  applicable  legal 
requirements and to ensure that, where relevant, benefits are shared. However, given 
the diversity of users within the Union it is not appropriate to oblige all users to take 
the same measures for exercising due diligence. Therefore, only minimum features of 
due diligence measures should be set out. The specific choices taken by users on the 
tools and measures applied for exercising due diligence should be supported through 
the  recognition  of  best  practices  as  well  as  complementary  measures  in  support  of 
sectoral  codes  of  conduct,  model  contractual  clauses,  and  guidelines  with  a  view  to 
increasing  legal  certainty  and  reducing  costs.  The  obligation  on  users  to  keep 
information  relevant  for  access  and  benefit-sharing  should  be  limited  in  time, 
consistent with the time-span for an eventual innovation. 

(15)  The  due  diligence  obligation  should  apply  to  all  users  irrespective  of  their  size, 
including  to  micro-enterprises  and  small  and  medium-sized  companies.  Excluding 
these actors from the system would entirely undermine its effectiveness. It would also 
run  against  the  international  obligations  of  the  Union  under  the  Nagoya  Protocol. 
However, the Regulation should offer a range of measures and tools to enable micro-
enterprises and small and medium-sized companies to comply with their obligations at 
low cost and with high legal certainty. 

(16)  Best  practices  developed  by  users  should  play  an  important  role  in  identifying  due 
diligence  measures  that  are  particularly  suitable  for  achieving  compliance  with  the 
system of implementation of the Nagoya Protocol with high legal certainty and at low 
costs. Users should be enabled to build on existing access and benefit-sharing codes of 
conduct  developed  for  the  academic  sector  and  different  industries.  Associations  of 
users  should  be  able  to  request  that  the  Commission  determines  whether  a  specific 
combination  of  procedures,  tools  or  mechanisms  overseen  by  an  association  may  be 
recognised  as  best  practice.  Competent  authorities  of  the  Member  States  should 
consider that the implementation of a recognised best practice by a user reduces that 
user's risk of non-compliance and justifies a reduction in compliance checks. The same 

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should apply to best practices adopted by the collective of the Parties to the Nagoya 
Protocol. 

(17)  Users  should  declare  at  identified  points  in  the  chain  of  activities  that  constitute  use 
that  they  have  exercised  due  diligence.  Suitable  points  for  such  declarations  are  the 
receiving of public research funds, when a market approval for a product developed on 
the basis of genetic resources is requested or at the time of commercialisation where a 
market  approval  is  not  required.  Notably,  the  declaration  made  upon  occasion  of 
requesting  market  approval  would  not  constitute  part  of  the  approval  procedure  as 
such and would be directed to competent authorities established under this Regulation. 

(18)  Collecting of genetic  resources in the wild is mostly undertaken for non-commercial 
purposes  by  university-based  researchers  or  collectors.  In  the  vast  majority  of  cases 
and in almost all sectors, access to newly collected genetic resources is gained through 
intermediaries, collections, or agents that acquire genetic resources in third countries. 

(19)  Collections  are  major  suppliers  of  genetic  resources  and  traditional  knowledge 
associated  with  genetic  resources  used  in  the  Union.  A  system  of  Union  trusted 
collections  should  be  set  in  place.  It  would  ensure  that  collections  included  in  the 
register of Union trusted collections effectively apply measures to only supply samples 
of genetic resources to third persons with documentation providing evidence of legal 
acquisition and the establishment of mutually agreed terms, where required. A system 
of Union trusted collections should substantially lower the risk that illegally acquired 
genetic  resources  are  used  in  the  Union.  Competent  authorities  of  Member  States 
would  verify  if  a  collection  meets  the  requirements  for  recognition  as  Union  trusted 
collection. Users that acquire a genetic resource from a collection listed in the Union 
register should be considered to have exercised due diligence as regards the seeking of 
all  necessary  information.  This  should  prove  particularly  beneficial  for  academic 
researchers as well as small and medium sized enterprises. 

(20)  Competent  authorities  of  Member  States  should  check  whether  users  comply  with 
their  obligations.  In  that  context,  competent  authorities  should  accept  internationally 
recognised  certificates  of  compliance  as  evidence  that  the  genetic  resources  covered 
were  legally  acquired  and  that  mutually  agreed  terms  were  established.  Competent 
authorities  should  also  keep  records  of  the  checks  made  and  relevant  information 
should  be  made  available  in  accordance  with  Directive  2003/4/EC  of  the  European 
Parliament and of the Council of 28 January 2003 on public access to environmental 
information.13 

(21)  Member States should ensure that infringements of the rules constituting the system of 
implementation of the Nagoya Protocol by users are sanctioned by means of effective, 
proportionate and dissuasive penalties. 

(22)  Taking  into  account  the  international  character  of  access  and  benefit-sharing 
transactions,  competent  authorities  of  the  Member  States  should  cooperate  between 
themselves,  with  the  Commission,  and  with  authorities  of  third  countries  to  comply 
with their duties within the system for implementing the Nagoya Protocol. 

13 

OJ L 41, 14.2.2003, p. 26. 

EN 

12 

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(23)  A  Union  platform  on  access  should  enable  discussions  on  and  contribute  to  the 
streamlining  of  access  conditions  in  Member  States,  the  design  and  performances  of 
access  regimes,  simplified  access  for  non-commercial  research,  access  practices  of 
collections  in  the  Union,  access  of  Union  stakeholders  in  third  countries  and  the 
sharing of best practices.  

(24)  The  Commission  and  the  Member  States  should  take  appropriate  complementary 
measures  to  enhance  the  effectiveness  of  implementing  this  Regulation  and  to  lower 
costs,  particularly  where  this  would  benefit  academic  researchers  and  small  and 
medium sized enterprises.  

(25) 

In  order  to  take  into  account  the  inherently  international  character  of  access  and 
benefit-sharing  activities,  the  Commission  should  also  consider  whether  cooperation 
with  third  countries  or  regions  could  support  an  effective  application  of  the  system 
created for implementing the Nagoya Protocol. 

(26)  The date of entry into force of this Regulation should be directly correlated to the entry 
into force of the Nagoya Protocol in order to ensure equal conditions at the Union and 
global  levels  in  activities  related  to  access  and  benefit  sharing  of  genetic  resources. 
The Nagoya Protocol will enter into force on the ninetieth day after the deposit of the 
fiftieth  instrument  of  ratification,  acceptance,  approval  or  accession  by  States  or 
regional economic integration organisations that are Parties to the Convention. 

(27) 

In  order  to  ensure  uniform  conditions  for  the  implementation  of  this  Regulation, 
implementing powers should be conferred on the Commission. Those powers should 
be  exercised  in  accordance  with  Regulation  (EU)  No  182/2011  of  the  European 
Parliament and of the Council of 16 February 2011 laying down the rules and general 
principles  concerning  mechanisms  for  control  by  the  Member  States  of  the 
Commission's exercise of implementing powers14. 

(28)  The  objectives  of  this  Regulation  are  to  minimise  the  risk  that  illegally  genetic 
resources  or  traditional  knowledge  associated  with  genetic  resources  are  used  in  the 
Union, and to support the fair and equitable sharing of benefits resulting from the use 
of genetic resources or traditional knowledge associated with genetic resources upon 
mutually agreed terms. These cannot be achieved by the Member States individually, 
and  can  therefore,  by  reasons  of  their  scale  and  to  ensure  functioning  of  the  internal 
market, be better achieved at Union level. The Union may therefore adopt measures in 
accordance  with  the  principle  of  subsidiarity as  set  out  in  Article  5  of  the  Treaty  on 
European Union. In accordance with the principle of proportionality, as set out in that 
Article, this Regulation does not go beyond what is necessary to achieve its objectives.  

14 

OJ L 55, 28.2.2011, p. 13. 

EN 

13 

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HAVE ADOPTED THIS REGULATION: 

Article 1 

Subject matter 

This Regulation establishes rules governing access and benefit-sharing for genetic resources 
and  traditional  knowledge  associated  with  genetic  resources,  in  accordance  with  the 
provisions of  the Nagoya  Protocol  on access to genetic resources and  the fair and  equitable 
sharing of benefits arising from their utilisation to the Convention on Biological Diversity (the 
Nagoya Protocol).  

Article 2 

Scope 

This Regulation applies to genetic resources over which states exercise sovereign rights and to 
traditional knowledge associated with genetic resources that are accessed after the entry into 
force of the Nagoya Protocol for the Union. It also applies to the benefits arising from the use 
of such genetic resources and to traditional knowledge associated with genetic resources.  

This Regulation does  not  apply  to genetic resources for which access and benefit-sharing is 
governed by a specialised international instrument to which the Union is a Party. 

Article 3 

Definitions 

For the purposes of this Regulation, the following definitions apply: 

(1) 

(2) 

(3) 

(4) 

(5) 

(6) 

"Nagoya Protocol" means the Nagoya Protocol on Access to Genetic Resources and 
the  Fair  and  Equitable  Sharing  of  Benefits  Arising  from  their  Utilization  to  the 
Convention on Biological Diversity; 

"genetic  material"  means  any  material  of  plant,  animal,  microbial  or  other  origin 
containing functional units of heredity; 

"genetic resources" means genetic material of actual or potential value; 

"access"  means  the  acquisition  of  genetic  resources  or  of  traditional  knowledge 
associated  with  genetic  resources  in  a  Party  to  the  Nagoya  Protocol  in  accordance 
with  the  applicable  domestic  access  and  benefit-sharing  legislation  or  regulatory 
requirements of that Party.  

"user"  means  a  natural  or  legal  person  using  genetic  resources  or  traditional 
knowledge associated with genetic resources; 

"use of genetic resources" means to conduct research and development on the genetic 
or biochemical composition of genetic resources; 

EN 

14 

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(7) 

(8) 

(9) 

(10) 

(11) 

"mutually  agreed  terms"  means  the  contractual  arrangement  concluded  between  a 
provider  of  genetic  resources  or  of  traditional  knowledge  associated  with  genetic 
resources and a user of such resources or knowledge, that sets out specific conditions 
for the fair and equitable sharing of benefits arising from such use, and that may also 
include further conditions and terms for the use of such resources or knowledge; 

"traditional  knowledge  associated  with  genetic  resources"  means 
traditional 
knowledge held by an indigenous or local community that is relevant for the use of 
genetic resources and that is as such described in the mutually agreed terms applying 
to the use of genetic resources; 

"collection" means an ensemble of collected samples of genetic resources and related 
information  that  is  accumulated,  stored,  and  taxonomically  identified,  whether 
owned by public or private entities; 

"association of users" means a legal person representing the interests of users that is 
involved  in  developing  and  overseeing  best  practices  under  Article  8  of  this 
Regulation. 

"internationally recognised certificate of compliance" means an access permit or its 
equivalent  issued  by  a  competent  national  authority  in  accordance  with  Article 
6(3)(e)  Nagoya  Protocol,  that  is  made  available  to  the  Access  and  Benefit-sharing 
Clearing-House; 

(12) 

"Access and Benefit-sharing Clearing-House" means the global information-sharing 
portal established under Article 14(1) Nagoya Protocol. 

Article 4 

Obligations of users 

1. 

Users shall exercise due diligence to ascertain that genetic resources and traditional 
knowledge associated with genetic resources used were accessed in accordance with 
applicable access and benefit-sharing legislation or regulatory requirements and that, 
where relevant, benefits are fairly and equitably shared upon mutually agreed terms. 
Users  shall  seek,  keep,  and  transfer  to  subsequent  users  information  relevant  for 
access and benefit-sharing. 

2. 

Users shall: 

(a) 

seek, keep and transfer to subsequent users information on: 

(1) 

(2) 

(3) 

the  date  and  place  of  access  of  genetic  resources  and  traditional 
knowledge associated with such resources; 

the  description  of  genetic  resources  or  traditional  knowledge  associated 
with such resources used, including available unique identifiers; 

the  source  from  which  the  resources  or  the  knowledge  were  directly 
obtained  as  well  as  subsequent  users  of  genetic  resources  or  traditional 
knowledge associated with such resources;  

EN 

15 

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(4) 

the  presence  or  absence  of  rights  and  obligations  related  to  access  and 
benefit-sharing; 

(5) 

access decisions and mutually agreed terms, where applicable; 

(b)  obtain additional information or evidence where uncertainties about the legality 

of access and use persist; and 

(c)  obtain a proper access permit, establish mutually agreed terms, or discontinue 
the  use  where  it  appears  that  access  was  not  in  accordance  with  applicable 
access and benefit-sharing legislation or regulatory requirements. 

Users  shall  keep  the  information  relevant  for  access  and  benefit-sharing  for  twenty 
years after the end of the period of use. 

Users  acquiring  a  genetic  resource  from  a  collection  listed  in  the  Union  register  of 
trusted  collections  referred  to  in  Article  5(1)  shall  be  considered  to  have  exercised 
due  diligence  as  regards  the  seeking  of  information  relevant  to  access  and  benefit-
sharing  for  genetic  resources  and  traditional  knowledge  associated  with  genetic 
resources. 

Article 5 

Union trusted collections 

The Commission shall establish and maintain a Union register of trusted collections. 
That register shall be internet-based, easily accessible to users, and shall include the 
collections  of  genetic  resources  identified  as  meeting  the  criteria  of  Union  trusted 
collection. 

Each Member State shall, upon request by a collection under its jurisdiction, consider 
the  inclusion  of  this  collection  in  the  Union  register  of  trusted  collections.  After 
verifying  that  the  collection  meets  the  criteria  set  out  in  paragraph  3,  the  Member 
State  shall  notify  the  Commission  without  delay  of  that  collection's  name,  contact 
details, and type. The Commission shall without delay include the information thus 
received into the Union register of trusted collections. 

3. 

4. 

1. 

2. 

3. 

In order for a collection to be included in the Union register of trusted collections, a 
collection owner shall demonstrate its capacity to: 

(a) 

apply standardised procedures for exchanging samples of genetic resources and 
related information with other collections, and for supplying samples of genetic 
resources and related information to third persons for their use; 

(b)  have  samples  of  genetic  resources  and  related  information  supplied  to  third 
persons  for  their  use  only  with  documentation  providing  evidence  that  the 
resources  and  the  information  were  accessed  in  accordance  with  applicable 
legal requirements and, where relevant, mutually agreed terms for the fair and 
equitable sharing of benefits; 

EN 

16 

   EN 

(c)  keep  records  of  all  samples  of  genetic  resources  and  related  information 

supplied to third persons for their use; 

(d) 

establish or use unique identifiers for samples of genetic resources supplied to 
third persons; 

(e)  use  appropriate  tracking  and  monitoring  tools  for  exchanging  samples  of 

genetic resources and related information with other collections. 

Member  States  shall  regularly  verify  that  each  collection  under  their  jurisdiction 
included in the Union register of trusted collections effectively applies the measures 
set out in paragraph 3. 

Member States shall inform the Commission without delay if a collection under their 
jurisdiction included in the Union register no longer complies with paragraph 3. 

Where  there  is  evidence  that  a  collection  included  in  the  Union  register  of  trusted 
collections  does  not  apply  the  measures  set  out  in  paragraph  3,  the  Member  State 
concerned shall without delay identify remedial actions in dialogue with the owner of 
the collection concerned. 

The  Commission  shall  remove  a  collection  from  the  Union  register  of  trusted 
collections  when,  in  particular  on  the  basis  of  information  provided  pursuant  to 
paragraph  4,  it  has  determined  that  a  collection  included  in  the  Union  register  of 
trusted collections faces important or persistent difficulties to comply with paragraph 
3. 

The  Commission  shall  be  empowered  to  adopt  implementing  acts  to  establish  the 
procedures for implementing paragraphs 1 to 5 of this Article. The implementing acts 
shall be adopted in accordance with the examination procedure referred to in Article 
15(2). 

Article 6 

Competent authorities and focal point 

Each Member State shall designate one or more competent authorities responsible for 
the application of this Regulation. Member States shall notify the Commission of the 
names and addresses of their competent authorities as of the entry into force of this 
Regulation.  Member  States  shall  inform  the  Commission  without  delay  of  any 
changes to the names or addresses of the competent authorities. 

The Commission shall make public, including on the internet, a list of the competent 
authorities. The Commission shall keep the list up to date. 

The  Commission  shall  designate  a  focal  point  on  access  and  benefit-sharing 
responsible  for  providing  information  to  applicants  seeking  access  to  genetic 
resources and traditional knowledge associated with such resources in the Union and 
to liaise with the Secretariat of the Convention on Biological Diversity. 

4. 

5. 

6. 

1. 

2. 

3. 

EN 

17 

   EN 

1. 

2. 

3. 

4. 

1. 

2. 

3. 

4. 

Article 7 

Monitoring user compliance 

Member  States  and  the  Commission  shall  request  all  recipients  of  public  research 
funding  involving  uses  of  genetic  resources  and  traditional  knowledge  associated 
with genetic resources to declare that they will exercise due diligence in accordance 
with Article 4. 

Users  shall  declare  to  the  competent  authorities  established  under  Article  6(1)  that 
they  exercised  due  diligence  in  accordance  with  Article  4  on  the  occasion  of 
requesting market approval for a product developed on the basis of genetic resources 
or  traditional  knowledge  associated  with  such  resources,  or  at  the  time  of 
commercialisation where a market approval is not required.  

Competent  authorities  shall  transmit  to  the  Commission  every  two  years  the 
information  received  on  the  basis  of  paragraphs  1  and  2.  The  Commission  shall 
summarise the information received and make it available to the Access and Benefit-
sharing Clearing House. 

The  Commission  shall  be  empowered  to  adopt  implementing  acts  to  establish  the 
procedures for implementing paragraphs 1, 2 and 3 of this Article. The implementing 
acts  shall  be  adopted  in  accordance  with  the  examination  procedure  referred  to  in 
Article 15(2). 

Article 8 

Best practices 

Any  association  of  users  may  submit  an  application  to  the  Commission  for 
recognising  as  best  practice  a  combination  of  procedures,  tools  or  mechanisms 
developed  and  overseen  by  it.  The  application  shall  be  supported  by  evidence  and 
information.  

Where, on the basis of information and evidence supplied to it by an association of 
users , the Commission determines that the specific combination of procedures, tools 
or mechanisms, when effectively implemented by a user, enables the user to comply 
with  its  obligations  set  out  in  Articles  4  and  7,  it  shall  grant  recognition  as  best 
practice. 

An association of users shall inform the Commission of any changes or updates made 
to a recognised best practice for which it was granted recognition in accordance with 
paragraph 2. 

If  evidence  from  competent  authorities  of  the  Member  States  or  other  sources 
indicates repeated cases where users implementing a best practice fail to comply with 
their  obligations  under  this  Regulation,  the  Commission  shall  examine  in  dialogue 
with the relevant association of users whether the repeated cases of non-compliance 
indicate possible deficiencies in the best practice.  

EN 

18 

   EN 

5. 

6. 

7. 

1. 

2. 

3. 

The  Commission  shall  withdraw  the  recognition  of  a  best  practice,  when  it  has 
determined that changes to the best practice compromise a user's ability to meet the 
conditions set out in Articles 4 and 7, or when repeated cases of non-compliance by 
users relate to deficiencies in the practice. 

The  Commission  shall  establish  and  keep  up  to  date  an  internet-based  register  of 
recognised  best  practices.  That  register  shall  list  in  one  section  best  practices 
recognised  by  the  Commission  in  accordance  with  paragraph  2  of  this  Article  and 
display in another section best practices adopted on the basis of Article 20(2) Nagoya 
Protocol. 

The  Commission  shall  be  empowered  to  adopt  implementing  acts  to  establish  the 
procedures for implementing paragraphs 1 to 5 of this Article. The implementing acts 
shall be adopted in accordance with the examination procedure referred to in Article 
15(2). 

Article 9 

Checks on user compliance 

The  competent  authorities  shall carry out checks to verify if users  comply with the 
requirements set out in Articles 4 and 7. 

The checks referred to in paragraph 1 of this Article shall be conducted in accordance 
with a periodically reviewed plan following a risk-based approach. When developing 
this risk-based approach, Member States shall consider that the implementation by a 
user  of  a  best  practice  recognised  under  Article  8(2)  of  this  Regulation  or  under 
Article 20(2) of the Nagoya Protocol reduces that user's risk of non-compliance. 

Checks  may  be  conducted  when  a  competent  authority  is  in  possession  of  relevant 
information,  including  on  the  basis  of  substantiated  concerns  provided  by  third 
parties, concerning non-compliance of a user with this Regulation. 

4. 

The checks referred to in paragraph 1 shall include at least: 

(a) 

(b) 

examination  of  the  measures  taken  by  a  user  to  exercise  due  diligence  in 
accordance with Article 4; 

examination of documentation and records that demonstrate the exercise of due 
diligence in accordance with Article 4 in relation to specific use activities; 

(c)  on the spot checks, including field audits; 

(d) 

examination of instances where a user was obliged to make declarations under 
Article 7. 

5. 

Competent  authorities  shall  accept  an  internationally  recognised  certificate  of 
compliance  as  evidence  that  the  genetic  resource  it  covers  has  been  accessed  in 
accordance  with  prior  informed  consent  and  that  mutually  agreed  terms  have  been 
established,  as  required  by  the  domestic  access  and  benefit-sharing  legislation  or 

EN 

19 

   EN 

6. 

7. 

8. 

1. 

2. 

1. 

2. 

regulatory  requirements  of  the  Party  to  the  Nagoya  Protocol  providing  the  prior 
informed consent. 

Users shall offer all assistance necessary to facilitate the performance of the checks 
referred to in paragraph 1, notably as regards access to premises and the presentation 
of documentation or records. 

Without prejudice to Article 11, where, following the checks referred to in paragraph 
1  of  this  Article,  shortcomings  have  been  detected,  the  competent  authority  shall 
issue a notice of remedial actions to be taken by the user.  

Additionally, depending on the nature of the shortcomings detected, Member States 
may  take  immediate  interim  measures,  including  inter  alia  seizure  of  illegally 
acquired genetic resources and suspension of specific use activities. 

The  Commission  shall  be  empowered  to  adopt  implementing  acts  to  establish  the 
procedures for implementing paragraphs 1 to 7 of this Article. The implementing acts 
shall be adopted in accordance with the examination procedure referred to in Article 
15(2). 

Article 10 

Records of checks 

The competent authorities shall keep records of the checks referred to in Article 9(1), 
indicating  in  particular  their  nature  and  results,  as  well  as  of  remedial  actions  and 
measures taken under Article 9(7).  

Records of all checks shall be kept for at least five years. 

The  information  referred  to  in  paragraph  1  shall  be  made  available  in  accordance 
with Directive 2003/4/EC. 

Article 11 

Penalties 

Member States shall lay down the rules on penalties applicable to infringements of 
the  provisions  of  Articles  4  and  7  of  this  Regulation  and  shall  take  all  measures 
necessary to ensure that they are implemented. 

The  penalties  provided  for  must  be  effective,  proportionate  and  dissuasive.  Those 
penalties may include: 

(a) 

fines; 

(b) 

immediate suspension of specific use activities; 

(c) 

confiscation of illegally acquired genetic resources. 

EN 

20 

   EN 

3. 

1. 

2. 

1. 

2. 

3. 

4. 

5. 

Member States shall notify the rules referred to in paragraph 1 to the Commission by 
[date]  at  the  latest  and  shall  notify  it  without  delay  of  any  subsequent  amendments 
affecting them. 

Article 12 

Cooperation 

The  competent  authorities  shall  cooperate  with  each  other,  with  the  administrative 
authorities of third countries and with the Commission in order to ensure compliance 
of users with this Regulation. 

The  competent  authorities  shall  exchange  information  on  serious  shortcomings 
detected  through  checks  referred  to  in  Article  9(1)  and  on  the  types  of  penalties 
imposed  in  accordance  with  Article  11  with  the  competent  authorities  of  other 
Member States and with the Commission. 

Article 13 

Union platform on access  

A  Union  platform  on  access  to  genetic  resources  and  traditional  knowledge 
associated with genetic resources is hereby established.  

The Union platform shall contribute to the streamlining of access conditions at Union 
level  by  discussing  related  issues,  including  the  design  and  performances  of  access 
regimes  established  in  Member  States,  simplified  access  for  non-commercial 
research, access practices of collections in the Union, access of Union stakeholders 
in third countries and the sharing of best practices. 

The Union platform may provide non-binding advice, guidance or opinions on issues 
under its mandate.  

Each Member State and the Commission may nominate one regular member for the 
Union  platform.  Stakeholders  and  other  experts  in  matters  addressed  by  this 
Regulation may be invited as appropriate.  

The  Union  platform  will  take  decisions  by  the  consensus  of  its  regular  members 
participating  in  a  meeting.  Decisions  on  procedure  may  be  taken  by  a  two-thirds 
majority of the regular members participating in a meeting. The first meeting of the 
Union  platform  shall  adopt  by  consensus  its  detailed  rules  of  procedure.  The 
Commission shall prepare, convene and chair the meetings of the platform.  

Article 14 

Complementary measures 

The Commission and the Member States shall, as appropriate: 

EN 

21 

   EN 

(a) 

(b) 

(c) 

support  information,  awareness  raising,  and  training  activities  to  help 
stakeholders to understand their obligations under this Regulation; 

support  the  development  of  sectoral  codes  of  conduct,  model  contractual 
clauses,  guidelines  and  best  practices,  particularly  where  they  would  benefit 
academic researchers and small and medium-sized enterprises; 

support  the  development  and  use  of  cost-effective  communication  tools  and 
systems in support of monitoring and tracking the use of genetic resources and 
traditional  knowledge  associated  with  genetic  resources  by  collections  and 
users; 

(d)  provide technical and other guidance to users, taking into account the situation 
of  academic  researchers  and  small  and  medium-sized  enterprises,  in  order  to 
facilitate compliance with the requirements of this Regulation. 

Article 15 

Implementing acts 

1. 

2. 

3. 

4. 

1. 

2. 

3. 

The  Commission  shall  be  assisted  by  a  committee.  That  committee  shall  be  a 
committee within the meaning of Regulation (EU) No 182/2011. 

Where  reference  is  made  to  this  paragraph,  Article  5  of  Regulation  (EU)  No 
182/2011 shall apply. 

Where  the  opinion  of  the  committee  is  to  be  obtained  by  written  procedure,  that 
procedure shall be terminated without result when, within the time-limit for delivery 
of  the  opinion,  the  chair  of  the  committee  so  decides  or  a  two-thirds  majority  of 
committee members so request.  

Where the committee delivers no opinion, the Commission shall not adopt the draft 
implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 
182/2011 shall apply. 

Article 16 

Reporting and review 

Member  States  shall  submit  to  the  Commission,  three  years  after  the  date  of  entry 
into  force  of  this  Regulation  and  every  five  years  thereafter,  a  report  on  the 
application of this Regulation. 

Not later than one year after the time-limit for submission of the national reports, the 
Commission shall draw up a report to be submitted to the European Parliament and 
the  Council.  The  report  by  the  Commission  shall  include  a  first  assessment  of  the 
effectiveness of this Regulation. 

Every ten years after its first report the Commission shall, on the basis of reporting 
on and experience with the application of this Regulation, review the functioning and 
effectiveness  of  this  Regulation.  In  its  reporting  the  Commission  shall  in  particular 

EN 

22 

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consider  the  administrative  consequences  for  public  research  institutions,  small  or 
medium-sized  enterprises  and  micro-enterprises.  It  shall  also  consider  the  need  for 
further  Union  action  on  access  to  genetic  resources  and  traditional  knowledge 
associated with genetic resources. 

The Commission shall report to the Conference of the Parties serving as the meeting 
of the Parties to the Nagoya Protocol on the measures that the Union and its Member 
States have taken to implement the Nagoya Protocol. 

Article 17 

Entry into force and application 

The Commission shall publish a notice in the Official Journal of the European Union 
that  the  Nagoya  Protocol  has  entered  into  force.  This  Regulation  shall  enter  into 
force on the twentieth day following the publication of that notice.  

Articles  4,  7,  and  9  shall  apply  one  year  after  the  date  of  entry  into  force  of  this 
Regulation. 

This Regulation shall be binding in its entirety and directly applicable in all Member 
States. 

4. 

1. 

2. 

3. 

Done at Brussels,  

For the European Parliament 
The President 

For the Council 
The President 

EN 

23 

   EN