Candidate List of substances of very
high concern (SVHC) announced by
the ECHA after proposals for measures
against the chemicals were proposed by
France, Sweden, Germany and Austria.
Under the EU’s core chemicals legislation REACH – Registration, Evaluation,
Authorisation and Restriction of
Chemicals – substances on the Candidate
List could need to be given authorization
to stay on the market and even then for
only a limited period until safer substitutes have been developed.
Alternatively they could be subject to
restrictions such as curbs on the way they
are used or on their range of applications.
The latest selection of four Candidate
chemicals brings the total on the list to
173 substances some of which have
been on it for several years. But BPA
may be prioritized for authorization
or restrictions because it is a relatively
high volume product with a global capacity of 2-2.5 million tons. Also being regarded by scientists and NGOs as
a major hazard, particularly since it is
seen as an endocrine or hormone disruptor, its safety has caused considerable debate since the 1990s.
Its addition to the Candidate List has
immediate implications for coatings producers, their raw materials supplier and
coatings purchasers.
Suppliers of articles or finished products which contain substances on the
Candidate List in a concentration above
0.1 percent by weight have to provide
information to their customers to allow
“safe use of the article,” according to the
REACH regulation. Consumers buying
the article can also request information
on safe use with the supplier having to
respond within 45 days.
Producers or importers of finished
products have to notify ECHA if their
articles contains a substance on the
Candidate List. This obligation applies
if the substance is present in the articles in quantities totaling over one ton
per producer or importer per year and
the substance is present in the finished
product above a concentration of 0.1
percent by weight.
For coatings producers a big concern
is the response of downstream customers
or end-users to the inclusion of the BPA
on the List. Recently when other chemi-
cals have been placed on the List brand
owners and retail chains have been re-
luctant to have them in their products.
The German Federal Institute for
Occupational Safety and Health (BAuA),
which has been acting as rapporteur for
BPA assessments for ECHA, is at present
drawing up a dossier with recommendations of either authorisation or restrictions on the chemical. Under REACH,
this is called a risk management option
analysis (RMOA).
The dossier will be examined by the
agency’s risk assessment committee
(RAC) of experts from the EU’s member
states to make proposals for a final decision by the European Commission, the
EU’s Brussels-based executive.
BAuA has sent round a questionnaire
to coatings and BPA producers and
other stakeholders across Europe asking
them about human and environmental
exposures and the possibility of reducing these.
The agency asks respondents if they
can reduce BPA concentrations and at
what cost to performance levels. It also
requests information on the development
of BPA alternatives.
ECHA’s selection of the chemical
for the Candidate List has not been
unexpected. In early 2016, the European
Commission classified BPA, first discov-
ered in 1891, as a category 1b presumed
human reproductive toxicant.
“That almost automatically catego-
rized it as a SVHC,” said Robinson.
Once identified as being carcinogenic, coatings and BPA producers have to
mention this danger in their safety data
sheets (SDSs) with suggestions of ways
of dealing with the risk.
BPA has been banned in baby bottles
in the EU since 2011. Late last year the
EU restricted the BPA content in thermal
paper to 0.02 percent by weight.
The French government banned
the manufacture and the use of BPA-based food contact materials five
years ago. The French Constitutional
Council, the country’s highest constitutional authority, intervened to allow
production for the export of materials on the grounds that the restriction
of trade was legally unjustified.
Last October the European
Parliament voted in favor of a ban on
the use of BPA in food contact materials.
The parliament does not have powers to
introduce legislation but it can exert influence in ways which can cause concern
to industry.
Prohibiting the use of BPA could have
a severe impact on coatings companies
and their customers in the packaging sector because it could effectively stop all
uses of the chemical.
“There is a danger that BPA being applied for other purposes could contaminate the machinery,” said Robinson.
The Commission is under pressure
to take further regulatory steps on BPA
because of the possibility that member
states might follow the example of France
by introducing their own measures.
But action through ECHA could
take some time. Once BAuA presents a dossier to the RAC, probably
late this year, it has 18 months to
make a recommendation on which the
Commission can take its time in making a final decision.
Meanwhile coatings producers will
have to grapple with the uncertainties of
not knowing what substances they can
use in their formulations in future. CW
“But BPA may
be prioritized for
authorization or
restrictions because
it is a relatively high
volume product with
a global capacity of
two to two and half
million tons.”
