COMMISSION STAFF WORKING DOCUMENT Implementation Plan Accompanying the document Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on mercury, and repealing Regulation (EC) No 1102/2008
Date: 2016-02-02
Institutions: Directorate-General for Environment, European Commission
Subjects: EU production, dental medicine, environmental protection, export restriction, import restriction, international convention, mercury, metal pollution, mining of ore, underground storage of waste

EUROPEAN 
COMMISSION 

Brussels, 2.2.2016  
SWD(2016) 18 final 

COMMISSION STAFF WORKING DOCUMENT 

Implementation Plan 

Accompanying the document 

Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 

on mercury, and repealing Regulation (EC) No 1102/2008 

{COM(2016) 39 final} 
{SWD(2016) 14 final} 
{SWD(2016) 17 final} 

EN 

   EN 

 
 
 
 
  
 
 
 
 
Implementation Plan1 

1.  Title of the document for the proposed act 

Proposal  for  a  Regulation  of  the  European  Parliament  and  of  the  Council  on  mercury,  and 
repealing Regulation (EC) No 1102/2008. 

2.  Contact point 

David Grimeaud (DG ENV.C4) 
Telephone: +32 229-64044 
Email: david.grimeaud@ec.europa.eu 

3.  Deliverables and implementation challenges 

The  Proposal  seeks  to  complement  the  EU  acquis  on  mercury  with  a  view  to  ensuring  full 
compliance  of  EU  law  with  the  Minamata  Convention  on  Mercury  (hereinafter,  "Minamata 
Convention" or "Convention") and consequently to allowing the EU and its Member States to 
ratify it.  

As this Convention reflects to a large extent the content of the EU acquis, including Mercury 
Export Ban Regulation (EC) No 1102/20082 this Proposal needs therefore only to address a 
few  issues  not  yet  tackled  at  EU  level,  including  the  establishment  of  restrictions  on  the 
import  of  mercury  and  on  the  import,  export  and  manufacturing  of  certain  mercury-added 
products,  the  control  of  the  use  of  mercury  in  specific  existing  manufacturing  processes,  in 
new products and processes and for artisanal and small-scale gold mining (ASGM), the use of 
dental  amalgam  and  the  implementation  of  best  environmental  practices  in  dental  facilities. 
From  this  list,  it  is  considered  that  the  potential  implementation  challenges  would  only  be 
ralated to the international trade in mercury and mercury-added products, as well as to the use 
of  mercury  in  new  manufacturing  processes  and  mercury-added  products  and  in  dental 
facilities.  

Accordingly, the potential implementation challenges that may be raised by this Proposal are 
limited to those listed below.  

3.1.  To control international trade in mercury and mercury-added products  

3.1.1  To restrict the import of mercury  

In  line  with  the  Minamata  Convention,  the  Proposal  establishes  a  restriction  regime  on  the 
import of mercury into the EU, which draws a twofold distinction, i.e. between imports from 
Parties  and  from  non-Parties  to  the  Convention  and  based  on  the  source  of  the  imported 
mercury. In particular, while imports into the EU of mercury from other Parties are allowed 
unless the mercury originates from prohibited primary mining, imports from non-Parties must 

1  This Implementation Plan is provided for information purposes only. It does not legally bind the Commission 

on whether the identified actions will be pursued or on the form in which they will be pursued. 

2   Regulation  (EC)  No  1102/2008  of  the  European  Parliament  and  of  the  Council  of  22  October  2008  on  the 
banning of exports of metallic mercury and certain mercury compounds and mixtures and the safe storage of 
metallic mercury, OJ L 304, 14.11.2008, p. 75.  

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be  based  upon  a  certification  from  the  exporting  country  that  imported  mercury  is  neither 
from  primary  mining  nor  from  mercury  used  in  the  chlor-alkali  industry.3  Additionally, 
mercury  imports  from  Parties  and  non-Parties  require  a  written  consent  for  the  importing 
Member State.  

The  Proposal  foresees  also  a  prohibition  on  mercury  import  when  intended  to  be  used  for 
ASGM,  irrespectively  on  whether  mercury  is  imported  from  a  Party  or  a  non-Party  to  the 
Minamata Convention.  

The potential implementation challenge for Member States will concern the traceability of the 
imported mercury, i.e. to ensure that it does not come from an unlawful source in breach of 
the  requirements  set  out  in  the  Convention  and  this  Proposal.  For  doing  so,  Member  States 
will  have  to  ensure  that  the  national  authorities  (e.g.  customs  authorities)  designated  under 
Regulation (EU) N° 649/2012 concerning the  export and import  of  hazardous chemicals4 to 
carry  out  the  administrative  functions  required  by  its  implementation  are  also  given  the 
responsibility and the means to control imports of mercury. In particular, those authorities will 
have  to  check  if  the  information  provided  by  the  exporting  country,  contains  precise  data 
regarding  the  origin  of  the  exported  mercury.  Moreover,  the  authorities  will  need  to  ensure 
that  the  imported  mercury  does  not  end  up  in  ASGM.  In  doing  so,  the  designated  national 
competent  authorities  may  undertake  to  identify  current  mercury  importers  and  liaise  with 
them so as to ensure that they are informed of the new import restrictions.  

3.1.2  To restrict the import, export and manufacturing of a set of mercury-added products  

In accordance with the Minamata Convention, the Proposal provides for a prohibition as from 
1st  January  2021  to  manufacture,  import  into  the  EU  and  export  from  the  EU  a  range  of 
products  when  they  contain  mercury,  including  batteries,  switches  and relays,  high  pressure 
mercury vapour lamps (HPMVs), pesticides, biocides and topical antiseptics and a set of non-
electronic  measuring  devices  (e.g.  thermometers)  or  when  their  mercury  content  exceeds  a 
given threshold, including button zinc silver or zinc air batteries, compact fluorescent lamps 
(CFLs),  linear  fluorescent  lamps  (LFLs),  cold  cathode  fluorescent  lamps  and  external 
electrode fluorescent lamps (CCFLs and EEFLs) and cosmetics.  

The  EU  acquis  addresses  already  the  placing  on  the  (EU)  market  of  all  the  mercury-added 
products  covered  by  the  Minamata  Convention  and,  in  some  cases,  the  import  of  such 
products into the EU. EU law sets also mercury-content requirements that are in some cases 
different (tighter) from those established in the Convention.  

Hence,  as  a  potential  implementation  challenge,  Member  States  will  have  the  obligation  to 
prevent  the  manufacture  (for  export)  in  their  territory  of  mercury-added  products  not 
complying with the requirements of the Minamata Convention and of this Proposal. To do so, 
depending on each national administrative system, Member States will have to ensure that the 
national competent authorities in charge, for instance, of the registration and authorisation of 
industrial and artisanal activities, including those manufacturing relevant products containing 
mercury, are provided with the responsibility and the means to undertake controls on an ad 

3 Regarding mercury from chlor-alkali facilities located in the territory of Parties to the Convention, these Parties 
have  the  obligation  to  dispose  of  excess  mercury  generated  from  the  decommissioning  of  those  facilities  as 
mercury waste.  
4 OJ L 201, 27.07.2012, p. 60. 

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hoc  basis  or  as  part  of  a  routine  inspection,  programme  and  to  review  and  revise  permits  if 
necessary. Another implementation challenge will be the implementation of adequate means 
to control imports and exports of the relevant mercury-added products to guarantee that only 
products complying with the  Convention and EU law are imported and exported. To do so, 
Member  States  will  have  to  make  sure  that  the  national  competent  authorities  (e.g.  market 
surveillance,  customs  authorities)  designated 
the 
requirements  set  out  in  several  EU  instruments  regulating  the  relevant  mercury-added 
products,  including  e.g.  Regulation  (EU)  N°  649/2012  concerning  the  export  and  import  of 
hazardous  chemicals, 
the  RHoS  Directive 
(2011/65/EU)6  and  the  Cosmetic  Products  Regulation  (1223/2009)7  or  any  other  competent 
authorities Member States may designate for that purpose, are also in charge of controling the 
implementation of the import and export restrictions and are provided with adequate control 
and enforcement means.  

the  Batteries  Directive 

implementation  of 

(2006/66/EC),5 

to  control 

the 

3.2.  To control mercury use  

3.2.1  To control the use of mercury in new manufacturing processes and in new mercury-

added products  

The  Minamata  Convention  provides  that  Parties  shall  discourage  the  manufacture  and 
marketing  of  mercury-added  products  not  covered  by  any  known  use  of  mercury-added 
products, unless an assessment of the risks and benefits of the product shows environmental 
or  human  health  benefits.  The  Convention  contains  a  similar  provision  regarding 
manufacturing processes, i.e. Parties shall discourage the development of any facility using a 
manufacturing process in which mercury or mercury compounds are intentionnally used that 
did not exist prior to the entry into force of the Convention, unless the Party concerned can 
demonstrate that it provides significant environmental and health benefits and that there are 
no technically and economically mercury-free alternatives available providing such benefits.  

Against  this  background,  the  Proposal  foresees,  on  the  one  hand,  an  a-priori  prohibition 
according  to  which  the  manufacture  and/or  placing  on  the  market  of  a  new  mercury-added 
product or the development of a new manufacturing process using mercury is prohibited. On 
the  other  hand,  the  Proposal  provides  that  a  new  mercury-added  product  or  manufacturing 
process using mercury might still be authorised at EU level, provided that it is demonstrated 
that the product or process would result in significant environmental and health benefits and 
that there would be no mercury-free alternatives available.  

Hence, the potential implementation challenge is the implementation of the conditions under 
which  a  new  mercury-added  product  or  the  development  of  a  new  manufacturing  process 
using mercury might be allowed. Regarding economic operators, they will have to provide ex 
ante relevant information to the competent authorities of the Member State concerned (where 
the manufacture and/or placing on the market of the new mercury-added product is expected 
to take place or where the new manufacturing process is foreseen to develop) to allow them to 
assess  whether  the  conditions  laid  down  in  the  Minamata  Convention,  as  transposed  in  the 
Proposal,  could  be  met.  The  Member  State  should  share  with  the  Commission  this 
information  and  its  opinion  on  whether  those  conditions  are  fulfilled.  The  Commission  will 

5 OJ L 266, 26.09.2006, p. 1.  
6 OJ L 174, 01.07.2011, p. 88. 
7 OJ L 342, 22.12.2009, p. 59. 

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then have to verify whether compliance with the requirements of the Proposal are met and, if 
so, adopt an Implementing Act authorising the new product or process. The Commission will 
also  keep  the  Secretariat  of  the  Minamata  Convention  informed  of  the  assessment  and  its 
outcome. Thus, in sum, whereas operators will have to provide all information necessary to 
justify the manufacture and/or placing on the market of a new mercury-added product or the 
development  of  a  new  manufacturing  process  using  mercury,  the  Member  State  concerned 
will  need  to  assess  the  sufficiency  and  content  of  the  information  so  provided  and  decide 
whether  a  notification  to  the  Commission  is  necessary  (i.e.  whether  the  new  product  or 
process  could  be  considered  as  meeting  the  applicable  conditions).  The  Commission  will 
assess and decide whether the concerned product or process could in fine be authorised on the 
EU market and territory.  

3.2.2  To control the use of dental amalgam 

In accordance with the Minamata Convention, the Proposal foresees that dental amalgam be 
used  only  in  an  encapsulated  form  and  that  dental  facilities  be  equipped  with  amalgam 
separators  aimed  at  collecting  and  retaining  amalgam  particles  with  a  view  to  preventing 
discharge of mercury residues into sewage systems and, in fine, into the environment. 

As potential implementation challenges, Member States will have to ensure that dentists that 
use  dental  amalgam  be  no  longer  supplied  by  mercury  suppliers  with  mercury  in  bulk,  but 
only dental amalgam in an encapsulted form. To do so, Member States may identify mercury 
suppliers that provide mercury to dentists located in their national territory and inform them 
of the new obligation on dental amalgam. As to dental facilities, they will have to ensure that 
their  dental  equipment  be  equipped  with  an  amalgam  separator,  that  this  separator  be 
regularly maintained to ensure a high level of mercury particle retention in accordance with 
applicable  ISO  and  CEN  standards  or  equivalent  national  standards  and  that  the  collected 
mercury particles be collected by an authorised hazardous waste collector.  

4.1.  Possible  Commission  actions 

to  promote  complete,  correct  and 

timely 

implementation of the proposed Regulation  

• 

• 

• 
• 

• 

• 

Creating a framework to enable an exchange of information on implementation. This 
framework may be integrated in existing or foreseen platforms and/or expert groups.  
Requesting  Member  States  to  nominate  contact  points  and  inform  the  ENV  contact 
point. 
Pursuing continuous informal dialogue with Member States' contact points. 
Updating the Europa website to include the Mercury Regulation, a section dedicated to 
implementation  duties,  deliverables  and  timetables,  links  to  relevant  implementation 
guidance and/or information, to FAQs and to good practice examples.  
Facilitating  bilateral  and/or  multilateral  meetings  with  Member  States,  where  there 
appear specific implementation challenges requiring further attention. 
Should implementation problems be identified and should informal bilateral dialogue 
fail  to  lead  to  a  complete  and  correct  implementation,  the  Commission  may  launch 
infringement procedures. 

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4.2. 

Possible Member State actions: 

• 

• 

• 

• 

Identify and nominate the appropriate liaison officers to take part in further technical 
discussions (mandatory). 
Inform  the  Commission  about  any  potential  problems  related  to  implementation  as 
soon  as  they  are  identified,  and  to  share  information  related  to  implementation 
(recommended). 
Set up dedicated national web-pages (recommended) in order to, inter alia: 
(cid:190) 
raise awareness and early adaptation to the new legal requirements;  
(cid:190) 
disseminate general information on the Regulation to the operators; 
(cid:190) 
offer a platform for FAQs and exchange of best practices. 
Develop e-services to support operators for, inter alia: 
(cid:190) 

notification  of  their  intent  to  manufacture  and/or  place  on  the  market  a  new 
mercury-added  product  or  to  develop  a  new  manufacturing  process  using 
mercury; 
reporting (e.g. on non-compliance); 
storing reported information in accordance with Article 12(2). 

(cid:190) 
(cid:190) 

6