Bättre EU-regler för en giftfri miljö - Kemikalieinspektionen

Some general issues (Chapter9)
There are some general issues which are discussed widely in the EU and which have an
impact on many different kinds of legislation.
As regards nanomaterials there is a great need to improve knowledge both with regard to
which materials are employed and are actually present in articles on the market, and to the
materials’ possible harmful effects on health or the environment. Work is taking place in the
OECD on the development of test methods. The issue is being dealt with in the EU’s
scientific committees where, for example, an evaluation is being made of UV filters with
nano-properties which are used in sun-protection products. A preliminary definition of the
nanomaterials concept has been produced by the Commission. In 2012 the Commission will
follow up an earlier report on regulatory aspects of nanomaterials. Where a general
assessment of possible risks with nanomaterials is concerned, we consider that REACH is
inadequate. Neither can REACH be employed to obtain broad knowledge of which products
containing nanomaterials that are present on the market. We therefore consider that Sweden
should support development in the EU of specific rules governing nanomaterials as a
complement to REACH.
Risks associated with endocrine-disrupting substances have been discussed in the EU since
the 1990s, but there is still a great need for the development of knowledge in this area. It is
important to ensure that the knowledge which has nevertheless been developed, e.g. in the
form of new test methods, should have an impact on the EU legislation. Swedish or Nordic
initiatives could relate to risk management of specific groups of substances with suspected
endocrine-disrupting properties, development and validation of test methods and dossiers for
adding to the candidate list for authorisation in REACH. In accordance with the proposal
from the Environmental Advisory Council, we should work towards endocrine-disrupting
substances being regarded as substances of very high concern in all EU rules.
The EU rules are poor with regard to dealing with combination effects, i.e. risks which arise
when several different chemicals interact in the environment. Sweden initiated a discussion
on the issue during its presidency of the EU in 2009, and the Commission will produce a
report in the course of 2012. An enhanced and harmonised methodology for dealing with
combination effects in respect of risk assessment is important, e.g. for the development of
REACH. The issue of combination effects is, however, very large and complex and is related
to how different legislations interact when managing risks in the environment.
Certain fluorinated substances (PFAS) have become very widespread in society and are
contained in a large number of consumer products. Some of the substances are extremely
persistent in the environment and some are bio-accumulative and toxic. Some are banned or
heavily restricted (PFOS and PFOA). Other variants are, however, found in the environment
and in the blood of humans. Levels are increasing, although they are still rather low.
Knowledge of possibly hazardous properties of the substances is at times very poor. We
consider that there is a risk of serious long-term problems if these stable substances prove to
have hazardous properties that are not known at present when they are already so widespread
in the environment and are showing trends towards rising levels which, moreover, can be
expected to increase if there is wider use of the substances. Knowledge of fluorinated
substances is increasing through extensive new research, and Australia, the USA and Canada
have produced specific plans of action for analysing the situation and assessing possible risks.
We consider that the EU needs, as a matter of priority, to produce a plan of action for
fluorinated substances.
20