Head of the Chemicals, diffuse pollution, agriculture

1
French initiative regarding nanomaterials
2
Context of a national initiative for
actionfindings

• Substances at nanoscale may exhibit different
  physico-chemical properties from those of the
  bulk substances
• ? Great potential for innovation but possible
  bad toxicological and ecotoxicological effects
  which are today difficult to assess

• The use of nanomaterials is already or expected
  to be widespread in a large variety of
  industrial sectors and consumer applications
  (computer, cosmetics, )?
• but the overview of what types of nanomaterials
  are or will be on the market remains currently
  incomplete

3
Context of a national initiative for actionmain
events

• From 2005 several expertises requested by the
  French government
• French agencies for safety (workers and
  environment AFSSET, food AFSSA, )
  
• The High Council of Public Health
• have been consulted on the issue of the impact
  of nanomaterials and on the way to go forward
• ? identification of scientific and technical
  gaps and need for action to handle risks
  scientific research and regulation

4
Context of a national initiative for actionmain
events

• 2007 national brainstorming in favour of a
  sustainable development called le Grenelle de
  lenvironnement
• Conducted by the ministry for sustainable
  development
• 3rd working group about Environment and Health
• All kinds of stakeholders involved state and
  regional administration, industry, employees,
  NGOs, elected representatives, scientific experts
• Public consultations via internet and public
  meetings in various locations
• ? action plan commitment about nanomaterials
  among and other emerging issues

5
Commitment n159 of Grenelle To anticipate
risks linked to nanomaterials

• Public debate organised by an independent
  commission (CNDP)
• Compulsory reporting of nanomaterials
• Balance cost/benefit of the use of nanomaterials
  in products
• Information and protection of workers according
  the results of AFSSET expertise

6
The Grenelle laws

• 2 projects to implement the commitments of the
  Grenelle
• Grenelle law n1
• Programmation law which describes the way to
  implement the commitments of the Grenelle
• Voted by the Parliament 23 July 2009
• Grenelle law n2
• Lays down a legal frame to implement the
  commitments
• Elaboration still ongoing

7
Grenelle law n1 article 42

• The national public debate
• Aims at
• - Informing the public about challenges,
  technical aspects, impacts of nanotechnologies in
  the most objective, accessible and complete way
• - Allowing the public to ask questions, to
  express its opinion
• - Enlightening the authorities before taking
  decision
• Free participation of everyone
• Conducted by a ad hoc independent commission
  composed by 6 members 1 president with various
  backgrounds (scientist, technicians, economist,
  historian)?
• 15 October 2009 to 24 February 2010
• Public meetings in 17 cities with themes adapted
  to the local context (ex tyres and automobiles
  industries in Clermont-Ferrand)?
• Internet www.debatpublic-nano.org

8
Grenelle law n1 article 42

• Within 2 years, a compulsory reporting to the
  authorities, regarding quantities and uses of
  nanomaterials and a supply of information to the
  public and consumers shall be enforced

• The authorities shall ensure that the information
  on risks and protection measures due to employees
  by employers is improved

• A methodology for assessing risks and benefits
  associated with these substances and products
  shall be developed

9
Why a compulsory reporting ?

• To obtain more information on what types of
  manufactured nanomaterials are on the
  market, in which quantities, from which
  companies and for which purpose
• ? Transparency and better knowledge of
  exposition of the population ?
  Better survey of sanitary impact on workers

• To make aware stakeholders of the concern raised
  by these particular substances and their
  properties
• ? Improvement of the risks management

• Voluntary reporting has already been experienced
  in 2007 by AFSSET the yield of response
  was very low (16 )?

10
The French compulsory reporting(Art.73 Grenelle
law 2)

• Who ? Manufacturers, importers, distributors
• What ?
• Identity of nanomaterials
• Quantities on the market
• Uses
• Data available on hazards on request of the
  authority

• To whom ? One authority a unique data base for
  all categories of products (chemicals, biocides,
  pesticides, cosmetics, food, )
• Public information about identity and uses of
  nanomaterials

11
The definition issue

• A definition of nanomaterials is needed to define
  the scope of the declaration
• International organisations such as OECD have
  provided a working definition
• Some definitions are already or are to be adopted
  in other regulations (cosmetics, food)?

• A definition will be adopted very soon in the
  French context, even if it will evolve in
  the future

• The French initiative doesnt seem to be isolated
• ? Harmonisation is necessary

12
Which interface with Reach ?

• Registration many issues are still outstanding
  and left, for the
  time being, to industrys appreciation
• Shall nanomaterials be regarded as as new or
  existing substances ?
• ? Consequences on the registration deadline ie
  on the availability of information
• How to assess correctly the risks of
  nanomaterials ?
• ? Consequences on the relevance of data and of
  management measures

• The registration threshold (1 t / y) is often
  inadequate

• Reach / nano subgroup of the competent
  authorities is currently working
  but the deadline is 2012, after the first
  registration deadline

13
Which interface with Reach ?

• The compulsory reporting will anticipate and be
  complementary to the Reach requirements, indeed

• Knowledge of the market quicker available and
  more explicit

• Knowledge covers manufacture, import and placing
  on the market below 1 t / y

• Input for the Reach / nano subgroup of the
  competent authorities (assessment of the need to
  revise Reach in 2012)?

• Awareness of industry about the need to care for
  its registration dossiers

• Help to prioritise registration dossiers and
  substances according to Title VI of Reach

• Help the authorities in charge of public health
  and environment to take action through Reach
  (SVHC, restrictions, ) to better manage the
  risks, if necessary

? Help to better apply Reach