presents proposal to modernise EU legislation
The European Commission today presented a proposal for a new
EU regulatory framework for chemicals. Under the proposed new
system called REACH (Registration, Evaluation and Authorisation
of CHemicals), enterprises that manufacture or import more than
one tonne of a chemical substance per year would be required
to register it in a central database. The aims of the proposed
new Regulation are to improve the protection of human health
and the environment while maintaining the competitiveness and
enhancing the innovative capability of the EU chemicals industry.
REACH would furthermore give greater responsibility to industry
to manage the risks from chemicals and to provide safety information
on the substances. This information would be passed down the
chain of production. The proposal has been drafted in close
consultation with all interested parties, including via an Internet
consultation. This has allowed the Commission to propose a streamlined
and cost-effective system. The proposal will now be forwarded
to the European Parliament and the EU's Council of Ministers
for adoption under the so-called co-decision procedure.
Enterprise Commissioner Erkki Liikanen said:
“I believe that we now have arrived at a proposal that
strikes the right balance between maintaining growth and employment
in Europe on the one hand and improving health and the environment
in Europe on the other. Both the chemicals industry itself
and Europe's manufacturing sectors that depend on chemicals
are key contributors to economic activity in all Member States.
Safeguarding their competitiveness is a priority. The mechanisms
built into today's proposal are cost-effective and they will
enhance the innovative capability of our industry. The proposal
will also provide for a stable framework within the internal
market and a new independent chemicals agency will help guaranteeing
Environment Commissioner Margot Wallström
said: "REACH is a groundbreaking proposal. Once adopted,
It will allow us to take advantage of the benefits of chemicals
without exposing ourselves and the environment to risks. Thus
it will create a win-win situation for industry, workers and
citizens, and our ecosystem. It will give Europe's citizens
the high level of protection that they have the right to expect.
The EU will have one of the most progressive chemicals management
systems in the world.”
The REACH system
The proposed Regulation would replace over 40
existing Directives and Regulations. At the core of the proposed
system is REACH a single, integrated system for Registration,
Evaluation and Authorisation of CHemicals. REACH would require
companies that produce and import chemicals to assess the
risks arising from their use and to take the necessary measures
to manage any risk they identify. This would reverse the burden
of proof from public authorities to industry for ensuring
the safety of chemicals on the market.
Registration: This is the main element of REACH.
Chemicals that were manufactured or imported in quantities
of more than one tonne per year and per manufacturer/importer
would be registered in a central database. Some groups of
substances would not have to be registered (such as certain
intermediates, polymers and some chemicals managed under other
EU legislation). The registration would include information
on properties, uses and safe ways of handling the chemicals.
The information required would be proportional to production
volumes and the risks that a substance poses. The safety information
will be passed down the supply chain, so that those that use
chemicals in their own production processes - to produce other
products - could do so in a safe and responsible way, without
jeopardising the health of workers and consumers and risking
damage to the environment.
A new European Chemicals Agency would manage
the database, receive the registration dossiers, and be responsible
for providing non-confidential information to the public.
It is expected that around 80% of all registered substances
would require no further action.
Evaluation: There would be two types of evaluation;
of dossiers and of substances. Firstly, a dossier evaluation
would have to be carried out on all animal testing proposals
The main purpose of this compulsory evaluation would be to
minimise animal testing. REACH has been designed with the
goal of restricting animal testing and costs to industry to
the necessary minimum. It would require the sharing of data
obtained in tests and encourages the use of alternative sources
of information. A dossier evaluation could also be performed
to check that the registration was in compliance with the
Secondly, the competent authorities could evaluate
any substance where they had justified reasons to suspect
that there was a risk to human health or the environment.
This would represent a quality and compliance check. The programme
of substance evaluations would be based on rolling plans prepared
by Member State Competent Authorities. The programme would
take account of criteria for setting priorities drawn up by
For both types of evaluation, the outcome could
be a request for further information. The Agency would take
the final decision on requests for further information if
all Member States agreed. In case of disagreement, the European
Commission would make a decision.
of very high concern would require authorisations for particular
uses from the Commission. Substances of very high concern
include CMRs, PBTs, vPvBs and substances identified as having
serious and irreversible effects to humans and the environment
equivalent to the other three categories. If the risks emanating
from the use of such a substance could be adequately controlled,
authorisation would be granted.
If they could not be adequately controlled,
the Commission would look at the level of risk, whether the
use of the substance was socially and economically important
and if there were substitutes. Based on these factors the
Commission would decide whether the substance would be authorised.
The Commission would also be able to introduce restrictions
at EU level on substances that needed to be managed at an
EU-wide level to ensure that the risks they posed were acceptable.
A balanced new system
The proposed new system would set high standards
for protection of health and the environment while safeguarding
the competitiveness of enterprises and improving the potential
for product innovation. This balance would be to the long-term
benefit of chemicals manufacturers, importers, users, small
and medium sized enterprises, consumers and for health and
To safeguard the competitiveness and enhance
the innovative capability of the chemicals industry in the
EU, REACH has been designed to simplify the existing EU regulatory
framework for chemicals. The proposed new system would thus
substances of high concern, including those
that are carcinogenic, mutagenic or toxic to reproduction
(CMRs), persistent, bio-accumulative and toxic (PBTs) or very
persistent and very bio-accumulative (vPvBs)
avoiding unnecessary bureaucracy by only requiring
essential safety and use information for chemicals manufactured
or imported in volumes of 1-10 tonnes per year
encouraging research and innovation by lengthening
the trial period, raising the threshold for the registration
of research substances and simplifying the regulation for
preventing increased bureaucracy for downstream
enterprises by utilising existing systems for the exchange
of safety information ie Safety Data Sheets (SDS). The SDS
is an internationally accepted tool for the communication
of information about chemical hazards, risks and risk reduction
helping enterprises deliver the objectives of
the system at minimum costs.
Incentives for research have been built into
REACH, which would enhance innovation. The proposed new system
would encourage research and innovation by raising the threshold
for registration from currently 10 kg to 1 tonne, thus allowing
research and development on substances to be carried out below
this volume without registration. In addition, the trial period
for research and development would be lengthened to up to
ten years. This period would be extended by a further 5 years
for medicinal products. For downstream users the new system
would mean a simplification of the regulation which would
make it easier for them to find new innovative uses of substances.
Costs and benefits
The overall costs of the proposal would be substantially
reduced compared to earlier estimates. The draft proposal
posted on the Internet earlier this year has been thoroughly
revised to cut costs and minimise bureaucracy. In the new
Impact Assessment, the direct costs of REACH to the chemicals
industry are estimated at a total of some € 2.3 billion
over an 11 year period representing a saving of 82% costs
from the Internet draft.
The costs to downstream users of chemicals are
estimated at € 2.8 to 3.6 billion over a period of 11
and 15 years respectively - if the market reacts as expected
with 12 per cent of substances being withdrawn because continued
production would not be profitable. Costs could rise to €
4.0 to 5.2 billion if industry faced higher supply chain adaptation
costs. These estimates include the direct costs passed on
from the chemicals sector to downstream users.
The total costs for the chemicals industry and
the downstream users are thus estimated to € 2.3 to 5.2
The anticipated benefits to environment and
human health are expected to be significant. An illustrative
scenario put the health benefits in the order of magnitude
of € 50 billion over a 30-year period.
REACH is an example of participatory policymaking.
The new system has been drafted in close consultation with
all interested parties, and various studies have been conducted
to examine the costs and benefits of different options.
In May of this year, the Commission presented
a draft of the proposed Regulation on the Internet to gather
further comments on the workability of REACH. Some 6,000 replies
were sent in. The main contributors were industry associations
and individual companies, as well as environmental and animal
rights NGOs. A number of Member States also provided comments,
alongside several countries outside the EU. In addition, many
individuals, including workers, expressed their opinions.
The comments have resulted in important changes
to make the proposed new system less costly, less bureaucratic
and more workable, while reinforcing the guarantees for health
and environmental protection.
Background - problems with the current legislation
The current legislative system for chemicals
has been largely unable to identify the risks posed by many
chemicals and is slow to act where risks have been established.
The current legislation distinguishes between
so-called "existing" and "new" chemicals
using 1981 as a cut-off date. "Existing” substances
are those that had been introduced before 1981; "new"
chemicals are those that have been introduced since.
New chemicals have to be notified and tested
in production volumes as low as 10kg per year, while there
are no such provisions for existing chemicals. This has encouraged
the continued use of "existing", untested substances
and inhibited research and development and innovation. The
number of new chemicals put on the market since 1981 has reached
only around 3,000.
The number of "existing" chemicals
in 1981 was 100,106. It has been up to the public authorities
to determine whether any of them need to be examined, and
if so, to do it. The procedures have been lengthy and cumbersome.
For example, since 1993 140 high-volume chemicals have been
singled out for risk assessment. Only a very limited number
has completed the process so far.