Bättre EU-regler för en giftfri miljö - Kemikalieinspektionen

• The limit values for metals in baby food need to be reviewed, and the Swedish National
Food Agency is working on this issue.
• There is a need to consider combination effects in a better manner.
• There is a need for increased knowledge of nanomaterials.
• In the application of the new rules regarding biocidal products, consideration needs to
be given to possible risks to people’s health if biocidal products are employed in the
vicinity of, or on, animals for food purposes or in contact with foods.
Medicinal products (Chapter 6.3)
Medicinal products are a category of chemical products covered by an EU legislation that is
harmonised in many respects. The general chemicals legislation (REACH etc.) largely does
not apply to medicinal products. There is considerable concern regarding the effects of
pharmaceutical substances which end up in the environment, e.g. with regard to the
development of antibiotics resistance and the effects of endocrine-disrupting substances. With
regard to the impact of medicinal products on the environment there are, however, a number
of shortcomings in the EU legislation, which have been addressed in several reports from the
Swedish Medical Products Agency and the Swedish Environmental Protection Agency These
shortcomings can be summarised as follows:
• The environmental risk assessments now being made in respect of medicinal products
prior to authorisation must be improved and developed. Medicinal products with older
authorisations (before 2005) also need to be assessed in terms of environmental risk.
• It must be possible for environmental aspects to be considered in the risk/benefit
assessment made in connection with the authorisation of medicinal products for human
use. Such consideration, under current rules, can only be taken in respect of veterinary
medicinal products, but it is also needed in respect of human medicinal products. If
environmental risks are to be weighed into the assessment, the competent authority for
medicinal products can impose environment-related conditions in order to reduce the
environmental impact, e.g. restrictions which are to be observed in use of the medicinal
product.
• In accordance with proposals from the Medical Products Agency, rules should be
introduced in the EU to counteract the release of environmentally harmful pharmaceutical
substances in the production of medicinal products. Work should be initiated in order to
prioritise which substances need to be regulated. By linking these rules to existing rules
regarding good manufacturing practice (GMP) they can, according to the assessment of
the Medical Products Agency, also have an impact in countries outside the EU.
The Water Framework Directive is an important piece of EU legislation with regard to the
management of environmental risks in the aquatic environment. Under a new proposal, three
substances which occur in medicinal products should be regarded as prioritised substances
under the Water Directive, which means that measures need to be taken when they occur in
the aquatic environment. It is important to follow the discussion about this proposal. As well
as the connection to the Water Directive there is a connection to the EU’s general strategy for
endocrine-disrupting substances and the discussion on combination effects, which we also
address in the report.
Cosmetics (Chapter 6.4)
The EU rules on cosmetics have recently been updated and are to be found in a new
regulation. The legislation is harmonised and deals with health aspects of the products. In the
rules there are exhaustive lists of substances which are not allowed in the products and
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