REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND THE COUNCIL Concerning Article 8a of Directive 98/70/EC relating to the quality of petrol and diesel fuels and amending Council Directive 93/12/EEC
Date: 2013-06-26
Institutions: European Commission
Subjects: adjuvant, diesel fuel, environmental impact, evaluation method, lead, petrol, product quality, public health, testing

EUROPEAN 
COMMISSION 

Brussels, 26.6.2013  
COM(2013) 456 final 

REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

Concerning Article 8a of Directive 98/70/EC relating to the quality of petrol and diesel 
fuels and amending Council Directive 93/12/EEC 

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REPORT FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT AND 
THE COUNCIL 

Concerning Article 8a of Directive 98/70/EC relating to the quality of petrol and diesel 
fuels and amending Council Directive 93/12/EEC 

1. 

INTRODUCTION 

Article 8a of Directive 98/70/EC (the “Directive”) requires the Commission to report 
its  conclusions,  on  the  development  of  a  test  methodology  to  assess  the  risks  for 
health  and  the  environment  from  the  use  of  metallic  additives  in  fuels,  to  the 
European Parliament and the Council. 

Metallic  fuel  additives  (“MFA”)  are  substances  intentionally  added  to  fuel  (petrol, 
diesel  and  biodiesel)  to  improve  its  performance1.  These  additives  eventually  enter 
the environment since their metallic portion is not degraded during any stage of their 
production  or  use.  Thus,  they  can  become  a  source  of  exposure  for  humans  and/or 
biota  throughout  their  life  cycle.  This  creates  a  possible  impact  on  health  and  the 
environment2  3. This potential impact justifies their regulation through the adoption 
of limit values based on the precautionary principle. 

The Directive contains a current limit value for methylcyclopentadienyl manganese 
tricarbonyl (“MMT”) of 6mg of manganese per litre. This value will become 2mg of 
manganese per litre from 1 January 2014. This limit value may be revised, through a 
Comitology  procedure,  on  the  basis  of  an  assessment  carried  out  following  the  test 
methodology referred to in this report. 

2. 

ASSESSMENT OF POTENTIAL RISKS FOR HEALTH AND ENVIRONMENT OF MFA 

There is a potential impact on health and the environment by the use of MFA in fuel. 
This  impact  is  affected  by  several  factors:  the  type  of  MFA;  the  level  of 
concentration;  the  level  and  duration  of  the  exposure;  and  the  pathway  for  this 
exposure. The metallic components of MFA could be a hazard for both humans and 
the environment due to their intrinsic reactivity, toxicity and their possible capacity 
to accumulate within living organisms.  

If a substance is considered hazardous to human health and the environment it would 
have to be assessed and labelled in accordance with the requirements of Regulation 
(EC)  No  1272/2008  on  the  classification,  labelling  and  packaging  of  hazardous 
substances and mixtures (“CLP Regulation”), prior to its placing on the market. 

Possible sources of emissions linked to MFA 

Emissions  of  MFA  may  enter  the  environment  during  any  stage  of  their  life-cycle 
from  production  to  disposal.  Such  emissions  can  result  in  the  direct  or  indirect 
exposure of humans and biota to the MFA, their related emitted compounds or their 
transformational  products  and,  as  such,  contribute  to  the  possible  risk  these 
substances may raise for human health and the environment.  

1 
2 

3 

This is dependent on many other factors such as engine compression, other constituents of fuels, etc. 
HEI  Special  Committee  on  Emerging  Technologies  (2011)  The  Future  of  Vehicle  Fuels  and 
Technologies:  Anticipating  Health  Benefits  and  Challenges.  Communication  16  –  Health  effect 
institute. Boston, Massachusetts. p.26.  
International Council on Clean Transportation (2008) Strategic Plan 2009-2011.  

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To assess the potential impacts of MFA on the compounds produced during vehicle 
fuel  combustion  and/or  remaining  in  the  exhaust  it  is  necessary  to  compare  the 
emissions produced with and without using MFA. In this context, the Commission’s 
Joint Research Centre has developed a test protocol4 for monitoring and calculating 
the emission data with regard to MFA, focusing on the use stage of their life-cycle. 
In  this  protocol,  measurements  are  made  at  the  tailpipe  and  the  emissions  are 
compared  for  fuel  containing  MFA  with  the  same  fuel  without  the  MFA.  The  test 
protocol includes an EU representative car fleet and does not contain predefined pass 
or fail criteria. The protocol aims to: 

• 

• 

• 

evaluate  the  short-term  effects  of  MFA  on  regulated  emissions  (namely  HC, 
CO, NOx, PM, PN and CO2); 

measure the mass of the metallic emissions produced by the combustion of the 
fuel  containing  MFA5,  and  determine  the  speciation  of  the  combustion 
products as well as particle size distribution of particle-bound metals; and 

evaluate  the  effects  of  MFA  on  the  long-term  emission  performance  of  the 
vehicle's engine and emission control system.  

This test protocol is an integral part of the methodology and its use is a mandatory 
part of the overall assessment of the risks for the environment and health of MFA.  

Possible exposure pathways 

The predominant routes of possible exposure throughout the life-cycle of MFA are: 

• 

• 

• 

• 

at the research and development, manufacturing and storage steps; 

in marketing, distribution and transport; 

at the point of use; and,  

from the environment in general. 

It is expected that occupational exposure would occur mainly at the first two steps in 
the  life-cycle  and  exposure  by  the  general  public  would  be  largely  confined  to  the 
final stage. Exposure would come from oral or dermal routes with inhalation being 
one of the main pathways for humans. 

Results and implications  

In  the  past  health  concerns  associated  with  MFA  (such  as  lead)  have  led  to  the 
phasing  out  of  their  use.  It  is  apparent  that  MFA  have  metallic  components  which 
could  in  themselves  be  a  hazard  for  both  humans  and  the  environment  due  to  their 
intrinsic  reactivity,  toxicity  and  their  possible  capacity  to  accumulate  within  living 
organisms. 

the  available  health  and 
New  substances  are  being  developed  for  which 
environmental  data  are  limited  and  little  is  known  about  their  eco-toxicity  and 

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Joint  Research  Center  (2011)  Protocol  for  the  evaluation of  effects  of Metallic  Fuel  Additives  on  the 
emissions performance of vehicles. 
Emission measurements should be carried out according to the European type approval procedure: “The 
exhaust gases are diluted and a proportional sample is collected in one or more bags. The exhaust gases 
contained  in  the  bag(s)  shall  be  analysed  as  soon  as  possible  after  the  end  of  the  test  cycle”.  The 
procedure  is  described  in  UNECE  Regulation  83,  revision  4,  26  April  2011:  “Uniform  provisions 
concerning the approval of vehicles with regard to the emissions of pollutants according to engine fuel 
requirements”. 

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toxicity.  Determination  of  their  toxicity6  and  eco-toxicity  is  a  prerequisite  to 
assessing their actual impacts on the environment and health. Hence there is a need 
to develop a test methodology. 

3. 

TEST METHODOLOGY 

The purpose of the methodology is to assess the risks for health and the environment 
from  the  use  of  MFA.  It  is  intended  to  be  sufficiently  generic  so  as  to  apply  any 
MFA.  Prior  to  the  assessment  a  holistic  approach  for  evaluating  the  environmental 
implications of various choices among chemicals, products and technologies may be 
needed  to  prioritise  efforts  and  to  provide  input  to  risk  managers  to  enable  better 
targeted decisions. Such a meta-assessment is shown below: 

Example of holistic approach for risk assessment of chemicals 
adapted from U.S. EPA (2011) 

The development of the methodology recognised that there are existing methods and 
processes  like  for  example  REACH  and  the  CLP  Regulation  in  place.  REACH 
already  proposes  guidance  to assess  the  risks  posed  by  chemical  substances,  so  the 
methodology  should  be  consistent  with  this  already  existing  approach.  However 
there is the necessity to assess specific risks for health and the environment from the 

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If a substance/mixture fulfils the criteria relating to physical, health or environmental hazards, it shall be 
classified before placing them on the market (Article 3 CLP). In so doing, manufacturers have to make 
use  of  all  available  information,  including  information  from  related  substances  that  can  be  used. 
Furthermore, suppliers of hazardous substances shall ensure that the substance/mixture is labelled and 
packaged  according  to  the  CLP  (Article  4  CLP).  Finally,  irrespective  of  their  tonnage,  substances  or 
mixtures  classified  as  hazardous  shall  be  notified  by  the  suppliers  to  the  Classification  and  Labelling 
Inventory of the European Chemicals Agency (Articles 39-42 CLP). 

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use of MFA. Consequently the methodology summarised in the figure below, is an 
adaptation of this framework for the specificities of MFA. 

CHARACTERISATION 
OF EMISSIONS 
DURING THE LIFE 
CYCLE

JRC Protocol 
for the use step

HAZARD 
ASSESSMENT

DEVELOPMENT 
OF EXPOSURE 
SCENARIOS

X

EXPOSURE
ESTIMATION

RISK 
MANAGEMENT

I

G
N
P
O
C
S

RISK 
CHARACTERISATION

Further details are as follows: 

Characteristic of emissions during the life-cycle 

Emissions  can  take  place  throughout  the  life-cycle  of  the  MFA  and  the  purpose  of 
this  step  is  to  provide  guidance  on  the  estimation  of  emissions  to  the  environment 
(i.e.  into  water,  soil  and  the  air)  of  MFA  including  combusted  compounds  and 
transformation products in the use phase. The Commission’s Joint Research Centre 
test protocol is required for the vehicle use step. 

Full details of the test protocol can be found on the Commission’s website: 

http://ec.europa.eu/clima/policies/transport/fuel/docs/fuel_metallic_additive_protocol_en.pdf 

Hazard assessment 

The  objective  of  this  step  is  collect  qualitative  and  quantitative  information  on 
possible  hazards  to  humans  and  the  environment  of  MFA,  emitted  compounds  and 
transformational products. 

Exposure assessment 

The  exposure  assessment  is  the  process  of  measuring  or  estimating  the  dose  or  the 
concentration of the substance to which humans and the environment are, or may be, 
exposed depending on the use of the substance. The exposure assessment would be 
performed in two steps: the development of exposure scenarios and the estimation of 
the exposure for both humans and the environment. 

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Risk characterisation 

The  risk  characterisation  has  to  be  performed  by  comparing  the  expected  levels  of 
exposure  to  the  predicted  no  effect  levels  from  the  hazard  assessment  for  both 
humans  and  the  environment.  The  ratio  between  the  exposure  and  no  effect  levels 
will  provide  a  rough  measure  of  the  risk  and  an  indication  of  (a)  whether  a  more 
refined risk assessment is needed and/or (b) whether or not steps to reduce or manage 
risks are appropriate. 

Risk management 

In  the  case  of  MFA  risk  management  is  typically  a  process  of  finding  a  balance 
between the benefits and risks of the substances. Given that this methodology calls 
for a comparative evaluation of fuels formulated with and without a given MFA the 
information  afforded  to  risk  managers  should  enable  them  to  judge  better  the 
risk/reward trade-offs of MFA in relative terms since risk management is inherently 
a matter of making choices between different options. 
Full details of the methodology7 can be found on the Commission’s website: 

http://ec.europa.eu/clima/policies/transport/fuel/docs/bio_report_en.pdf 

Application of methodology 

The  Commission  notes  that  the  methodology  envisages  that  any  interested  party 
applying  the  methodology  will  establish  an  advisory  board  comprising  members 
recognized  as  impartial  and  objective  authorities  in  various  technical  disciplines, 
including fields such as vehicle and fuels technology, exposure analysis, health and 
ecological  effects,  and  risk  assessment/management  “to  assist  in  and  advise  during 
the preparation and performance of the assessment.” While the Commission does not 
have a legal basis to require or regulate such advisory boards it does recognise that 
such  an  advisory  board  can  contribute  to  ensuring  that  the  result  of  the  assessment 
can  withstand  scientific  scrutiny,  be  credible,  reproducible  and  be  established  in  a 
transparent  manner.  Accordingly,  the  Commission  stands  ready  to  provide  advice 
regarding the composition of an advisory board when requested. 

4. 

CONCLUSION 

It  is  apparent  that  there  is  a  potential  impact  on  health  and  the  environment  by  the 
use of MFA. In order to assess this impact a methodology has been developed to be 
employed by any party interested in the establishment or revision of limit values for 
MFA in the Directive. 

The Commission will monitor the application of this methodology and will take all 
appropriate initiatives.  

7 

Report prepared by BIO Intelligence Service for the European Commission: Development of a risk assessment for 
health and the environment from the use of metallic additives and a test methodology for that purpose. 

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