Last updated: 25/03/2015
Introduction
Biocides are chemicals used to suppress organisms that
are harmful to human or animal health, or that cause damage to natural or
manufactured materials. These harmful organisms include pests and germs (i.e.
moulds and bacteria). Examples of biocidal products are insect repellents,
disinfectants and industrial chemicals like anti-fouling paints for ships and
material preservatives. However, because of their intrinsic properties biocides
can pose risks to humans, animals and the environment.
The new Regulation entered into force on 1 September 2013. It repeals Directive 98/8/EC
and aims to provide a high level of protection for humans, animals and the
environment.
Regulation concerning the making available on the market and use of
biocidal products
Overview
The objective of the new
Regulation is to improve the functioning of the internal
market in biocidal products whilst ensuring a high level of environmental and
human health protection. The new Regulation will also remedy a number of
weaknesses that were identified during the 11 years of implementation of the
current Directive 98/8/EC.
The new text simplifies and streamlines the
requirements for approving active substances and authorizing products. The new
provisions will also reduce animal testing by making data sharing compulsory
and encouraging a more flexible and intelligent approach to testing. A
dedicated IT platform (the Register for Biocidal Products) will be used for
submitting applications as well as recording decisions and disseminating
information to the public. The new Regulation is also the first piece of
legislation to build in the new Commission definition on nanomaterials.
The text is also a major breakthrough for the internal
market with the creation of a Union authorisation of biocidal products, which
will allow industry to directly place their products on the entire Union
market.
The European Chemicals Agency (ECHA) will provide a
strong scientific and technical back-up to the Commission and the Member States
under this new Regulation. 100 persons will eventually work on biocides related
activities for a total annual budget of 25 Mion EUR.
ECHA will in particular be responsible for the
assessment of applications for the Union authorisation of biocidal products.
The total number of opinions to be delivered by ECHA
is expected to grow from 80 in 2014 to 300 in 2020.
The total cost savings for the industry – to be
achieved through the measures concerning product authorisation, data sharing
and data requirements – are significant and estimated to ca. €2.7 billion over
a period of 10 years.
Key features of the new Regulation
The Regulation concerning the making available on the
market and use of biocidal productswill repeal and replace Directive 98/8/EC
and will be applicable as of 1 September 2013.
The current Directive establishes a two-step process
of approval:
1. evaluation of the active substance at the Union level, and
2. product authorisation at Member State level.
The Regulation will maintain this two-step approach
while providing for the possibility that some biocidal products are authorised
at the Union level giving them direct access to the entire Union market.
Key elements of the new Regulation:
·
Provide for the authorisation
at the Union level of certain biocidal products;
·
Improve the functioning of
national authorisations and mutual recognition by introducing binding deadlines
and strengthening the system of mutual recognition dispute settlement;
·
Reduce the number of animal
tests by obligatory data sharing with respect to vertebrate animal studies;
·
Strengthen the rules on data
waiving (i.e. not request data which is not necessary);
·
Extend the scope to cover
articles and materials treated with biocidal products (e.g. furniture treated
with wood preservatives), which are imported from third countries;
·
Harmonised fee structure which
will harmonise the conditions and criteria for setting the fees in all Member
States;
·
The European Chemicals Agency
(ECHA) will be involved in the scientific work on biocides;
·
Persons placing biocidal
products on the market will have to hold the data on active substances (before
they are obliged to do so under the product authorisation application).
Scope (Article 2)
General principles
The scope of the Regulation has been extended compared to the former
Directive to cover articles and materials treated with biocidal products,
including furniture and textiles.
The Regulation also applies to active substances generated in situ,
and to biocidal products used in materials that come into contact with food.
Other products that are sufficiently covered by existing legislation
(including food and feed, food and feed additives and processing aids) are
excluded from the scope of the new Regulation.
Biocidal products approved under the International Convention for the
Control and Management of Ships' Ballast Water and Sediments are considered as
authorised.
Dual use
A provision on dual use is intended to address the case of biocidal
products (and not of treated articles) which have a dual function, such as for
instance biocidal products, which are used as both plant protection products
and biocidal products. It stipulates that such products fall under the scope of
two different legislative instruments.
Antimicrobial soaps, sun blockers with insect repelling activity,
insecticidal paints might be other examples of products that would fall under
the scope of the new Regulation as well as of other legislation (e.g.
cosmetics, paints).
Toys
The new Regulation on biocidal products contains provisions which apply not
only to biocidal products but also to all articles, which have been treated
with or incorporate a biocidal product.
In the absence of derogation, toys containing preservatives - which are
biocidal products - would have been subject to the Regulation's provisions on
treated articles.
However, as toys are already regulated through specific
legislation, which provides for similar provisions, the two
legislators agreed to leave toys out of the scope of the new Regulation.
In particular, the European Committee for Standardisation’s (CEN) toy
safety standards EN71-5 and EN71-7 explicitly require toy manufacturers to use
foodstuff and cosmetics preservatives in order to prove compliance with the Toy
Safety Directive 2009/48/EC.
Definitions (Article 3)
Biocidal products
The
definition makes a distinction between those substances, mixtures and articles
that shall be regarded as biocidal products and those which shall not.
For
articles, it makes a critical distinction between, on the one hand, articles
which shall be regarded as biocidal products and will be
subject to the entire Regulation because they are primarily biocidal products
and, on the other hand, those which will be regarded as treated
articles and shall only be subject to limit parts of the Regulation
because there are not primarily biocidal products.
In-situ generation
of active substances
In-situ
generated active substances are covered by the provisions of the Regulation.
The devices used to generate these substances are however not covered.
This means
that devices per se will not be subject to the authorisation requirements.
However, some of the aspects directly linked to their safety or efficacy could
be considered during the assessment of the substance generated by these
devices.
Precursors
placed on the market with the intention to generate active substances in situ
will be covered by the first subparagraph of the definition of a biocidal
product, and will require substance approval and product authorisation before
they can be made available on the market.
Active
substances generated from substances or mixtures which are not themselves
biocidal products (e.g. ozone generated from the air, chlorine generated from
kitchen salt or sea water) will be covered by the second subparagraph of the
definition of a biocidal product. As a consequence, the use of these substances
will not be allowed unless the generated substances have been approved and
authorised as a biocidal product.
In those
cases where the substance is generated through a device intended for this
purpose, the person placing the device on the market will have to hold a
product authorisation for the generated substance, which he is indirectly
placing on the market.
A transitional
measure is also provided (Article 93) to allow for the authorisation of those
in-situ products which under the current Directive can be used without
authorisation (e.g. ozone).
Nanomaterials
The
Regulation is the first piece of legislation to build in the new Commission
definition on nanomaterials.
Product family
The new
Regulation provides for a simplified and more flexible approach for products
having very similar compositions. In short, the concept of product family
(which replaces the former concept of frame formulation) is provided to
underpin and allow for a streamlined and simplified procedure for granting
authorisations to very similar products which only vary in terms of relatively
minor differences in composition and have the same use and user type.
Animal testing and the new
Regulation
Although
the new Regulation will not ban animal testing completely, it attempts to
minimise it as far as possible. It introduces an obligation to share data on
vertebrate animal tests in exchange for fair compensation, and a prohibition to
duplicate such tests. This is expected to save both costs and animal lives.
The new
Regulation also encourages data-sharing for non-animal tests, with a similar
view to reducing the overall costs of the legislation to the industry and
avoiding the duplication of efforts. The data sharing process will be
administered by the European Chemicals Agency (ECHA), in consultation with
applicants.
Under the
new Regulation, applicants may consult with a Member State Competent Authority
regarding their proposal for data requirements and in particular any proposed
animal testing. In addition, Member States have to inform and if possible
assist applicants with adaptation requests to data requirements.
The new
Regulation also changes the rules concerning core data requirements. Under the
current directive, the same set of data must be submitted for all biocidal
products, not all of which is always necessary. The new Regulation establishes
a more systematic approach to the waiving of data requirements.
The grounds
for data waiving provided for in REACH will apply. In practice, this
means that data should be submitted to support a risk assessment only when
necessary. It also means that the Regulation recognises that there are
situations when data requirements can be addressed by means other than testing
on animals and when human or environmental exposures are so low that additional
data doesn't necessarily increase the ability to manage risk. Certain long-term
animal studies, for instance, will only be required when necessary. These are the
most costly data requirements, both financially and in terms of lives of test
animals
The
Regulation introduces specific and general rules for the adaptation of data
requirements. These rules should be considered in conjunction with the core and
additional data when preparing the initial information requirement
proposal. As regards general adaptation rules, testing may be waived if
it's not deemed necessary, as the required information may be provided using:
existing data or weight of evidence; QSAR; in-vitro methods; or grouping or
read across approaches. Testing that is not scientifically possible or based on
reduced exposure can also be waived.
Finally,
all use of animals for scientific purposes must comply with the provisions set
out in the Directive
2010/63/EU, which enters into force on 1 January 2013. The new Directive strengthens,
and significantly improves on the legislation in this area.
Data
protection and data-sharing (Chapter XIV)
In line with recent policy developments in REACH and the Regulation on the
placing of plant protection products on the market, sharing of vertebrate
animal studies in exchange for equitable compensation becomes mandatory. This
is expected to save costs and animal lives by prohibiting the duplication of
these studies.
The data protection system is significantly simplified, without cutting
back on any acquired rights under the system provided for under the Directive.
It also grants protection to data submitted after the approval of an active
substance (mainly during product authorisation). These studies were not
protected under the Directive.
The new data protection system also covers the case of newly generated studies
that under the Directive, and contrary to the legislator's intention, did not
benefit from data protection because certain Member States required their
submission for the purposes of national authorisation during the transitional
period (only data submitted for the first time in support of the first
inclusion of the active substance were protected under the Directive).
National authorisation and mutual recognition (Chapter VII)
The Regulation provides for harmonised procedures for the authorisation of biocidal products, an element that is significantly underdeveloped in the current Directive.
The provisions regarding mutual recognition of authorisations are reworked and clarified, in particular the resolution of disputes between Member States, or between Member States and applicants. This is expected to contribute to a smooth functioning of the upcoming authorisations of biocidal products.
The mutual recognition procedure, relies on the principle that once a first authorisation is granted by a Member State, the applicant can ask for the recognition of that authorisation by other Member States.
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