Executive Summary
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This report recapitulates issues relevant for the
on-going discussion on transparency and requests for more information regarding
the use of nanomaterials (NMs) in consumer products. It reviews content related
labelling of products containing NMs and the establishment of product registers
for such products and contributes to the debate on the need for such measures
and their possible impact. The addressees of the report include policy makers,
EU Member State authorities, industry, NGOs, research institutes and consumers.
The number and amount of consumer products and
applications using nanotechnology on the market are rapidly increasing.
Technological innovations at the nanoscale are exploited in novel products, but
may at the same time involve unknown risks. The safety of products containing
NMs is regulated by several EU legal acts that address chemicals and products
in general including the Chemicals Regulation REACH, the Classification and
Labelling of Products Regulation, General Products Safety Directive and others.
In addition, NMs are explicitly addressed in a number of recently revised
sector specific legislations (e.g. the Regulations for Biocidal Products,
Cosmetic Products, Provision of Food Information to Consumers, Active and
Intelligent Materials and Articles, and Plastic Food Contact Materials).
However, several stakeholders, for example the European Parliament, some EU
Member States and non-governmental organisations, have requested more
transparency and traceability concerning the use of NMs in consumer products on
the market. The report summarises EU legislation and how it addresses NMs.
Labelling consumer products containing NMs and/or
making information on NM content available in product registers or inventories
are measures to provide information and traceability of their use. Labelling
provides information to the consumer at the time of purchase, while a product
register may give a better overview of the overall application of NMs and
potential exposure of humans and the environment. Mandatory labelling
requirements regarding the content of NMs (in an ingredients list) are already
part of EU legislation on food, cosmetics and biocides. Mandatory reporting to
the European Commission (EC) is required for cosmetic products containing NMs
and some EU Member States are introducing mandatory reporting schemes for a
wider range of consumer products (France, Belgium and Denmark). Labelling
and/or registration of NMs in consumer products should be understood as a
"risk-independent" description of the composition of the product,
since the presence of NMs does not automatically imply a risk. Any information
provided needs to be adequate and proportionate to the knowledge of the consumers
and should not lead to any discrimination of products. Any means to increase
information and transparency should preferably be harmonised at least within
the EU or even at an international level to avoid trade barriers and unfair
commercial practices. The report discusses the different options and their
influence both on labelling and creation of registers.
Identification of products containing NMs and market
transparency requires a harmonised definition of the term
"nanomaterial". Several definitions are available, including a
Recommendation by the European Commission. A claim of the presence (or absence)
of NMs in products should be enforceable and possible to monitor. Currently
available methods allow in principle the detection and quantification of NMs,
also when they are embedded in simple matrices, but these methods are not yet
standardised nor generally agreed upon. Routine application of detection
methods in complex matrices, such as in cosmetics or food, still needs
considerable development. The report gives an overview of the state of the art
of verification methods.
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