| activities |
added |
-
- date
- 2003-10-29
- docs
-
- text
PURPOSE : to amend Directive 67/548/EC on packaging and
labelling in order to adapt it to the provisions of the proposals
on REACH (Please see COD/2003/0256).
PROPOSED ACT : Directive of the European Parliament and of the
Council.
CONTENT : Directive 67/548/EEC sets out rules not only how to
classify, package and label dangerous substances, but also how to
notify new substances to the Competent Authorities in the relevant
Member State before placing them on the market.
The Commission has presented proposals on a single regulatory
system for all substances (entitled REACH for the Registration,
Evaluation and Authorisation of Chemicals) and giving industry the
responsibility for generating data on the inherent properties of
substances and for assessing the risks related to their use.
The new REACH Regulation will introduce the same registration
requirements for new chemicals as for the existing substances which
means that the rules for notification of new chemicals in Directive
67/548/EEC have to be repealed. However, the REACH proposal does
not at present include rules for classification, labelling and
packaging of dangerous substances, and the relevant parts of
Directive 67/548/EEC will continue to apply.
Directive 67/548/EEC contains several Annexes related to
information requirements and testing methods to be used. The
content of these annexes will be taken over by the Annexes to the
REACH legislation and thus they have to be repealed from the
Directive. Moreover, a substantial number of references to testing
methods and information requirements must be amended as a
consequence of the introduction of the REACH legislation.
In addition, the proposal seeks to repeal Commission Directive
93/67/EEC.
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The Council took note of Commissioner Liikanen's presentation
of the legislative proposal for a Regulation on the registration,
evaluation, authorisation and restriction of chemicals (REACH) and
instructed the Permanent Representatives Committee to examine the
proposal as a matter of priority as soon as it has been
transmitted.
The objective of the REACH proposal is to improve the protection of
human health and the environment against chemical hazards while
ensuring the proper functioning of the internal market and
maintaining the competitiveness of the chemicals industry.
The following main issues emerged from the Council's debate which
followed the presentation of this legislative proposal:
- a large majority of delegations welcomed the amendments
introduced by the Commission in its final proposal which takes into
account some of the concerns expressed by different sectors
consulted, primarily as regards the scope of the REACH system and
the associated costs for industry;
- sharing the need for a balanced approach taking into account
competitiveness, environmental and health aspects as equally
important, delegations welcomed the decision taken by the Permanent
Representatives Committee to set up an ad hoc Working Party on
Chemicals with a broad mandate to examine the proposal in all its
aspects;
- during the debate, the Commission underlined that it had
presented an impact assessment of costs for industry. Many
delegations stressed the importance of such comprehensive impact
assessment, in particular as regards SME's and other users of
chemicals;
- some delegations were of the opinion that indirect costs
resulting from the application of the REACH system would still be
considerable and had to be examined carefully; and
- several delegations underlined the role to be played by the
proposed Chemicals Agency in coordinating the evaluation procedure
and thus ensuring that there are no distortions in the application
of the rules.
It is recalled that the last European Council (16/17 October)
indicated in its conclusions that "European Union legislation
should not be a handicap to EU competitiveness compared to that of
other major economic areas. To this end the Commission is invited
to take into account the consequences of proposed EU legislation on
enterprises through providing a comprehensive impact assessment.
The forthcoming proposal on chemicals, which will be examined by
the Competitiveness Council in coordination with other Council
configurations, will be the first case for implementing this
approach, taking in particular into account its effects on
SMEs.
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The Council held a policy debate on the proposals for a
Regulation and for a Directive on registration, evaluation,
authorisation and restriction of chemicals and on the establishment
of a European Chemicals Agency, with a view to giving political
guidance for further work by forthcoming Presidencies.
Delegations were invited to answer the following indicative
questions suggested by the Presidency:
- whether, having regard to the relative roles and contributions
of the authorisation and restrictions processes for the management
of risks to human health and the environment from substances of
very high concern, and the inter-relationship between these two
processes, there is merit in exploring the scope for improving the
workability of the proposal so that the underlying objectives are
met in a timely and resource-efficient manner ?
- whether the Council considers that the Commission proposal
covers the essential elements to encourage substitution for
substances of very high concern so as to reduce the risks to human
health and the environment while stimulating innovation and
enhancing the competitiveness of European industry ?
- whether the Council considers that the Commission proposal
provides adequately for the quality of data provided by industry,
or that there is merit, in the ongoing examination of REACH, in
investigating the need for additional measures ?
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- 2004-06-28
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- 2004-09-23
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The Council held a policy debate on the draft Regulation for the
Registration, Evaluation, Authorisation and Restriction of
Chemicals (REACH), and establishing a European Chemicals Agency.
The debate took place on the basis of a Presidency Report which
reflected discussions so far in the ad hoc Working Party on
Chemicals, established in November 2003.
At the end of the debate, the Presidency stated that a number of
key issues have been discussed during the policy debate, the
purpose of which was to give political guidance for work under the
subsequent Presidencies.
The Council took note of the Presidency's report on the basis of
which it held a policy debate addressing a set of key issues,
notably: conclusions and recommendations from the REACH Impact
Assessment Workshop; mandatory sharing of nonanimal data, including
agreements on core data sets and cost sharing; and information
requirements for low volume substances.
As to the Workshop on REACH Impact Assessment held in The Hague
on 25-27 October 2004, the Council welcomed the conclusions and
recommendations and instructed its preparatory bodies in
cooperation with the Commission to take account of them in the
future work.
Concerning the issue of joint submission of data including cost
sharing, the Council stressed the importance of avoiding
unnecessary testing on animals and underlined the need to improve
the protection of the human health and the environment while
ensuring the competitiveness of the European chemicals industry, in
particular of SMEs. In this context, the Council discussed a
suggestion implying mandatory sharing of all data, including
legally-binding rules on cost sharing, as a possible means to
achieve these objectives. While there was support, the Council
called for further examination of this issue, taking into account
the Opinion of the Council Legal Service.
The Council discussed the question of a possible extension of
the data requirements for low volume substances (1-10 tonnes per
year). Member States acknowledged the importance of having
sufficient data to enable appropriate classification and labelling
and to ensure the protection of human health and the environment,
especially as to the identification of substances of high concern,
such as PBTs and vPvBs. Member States stressed the importance of
achieving the right balance between costs of additional data
(specifically for SMEs) and benefits. The importance of taking into
account the competitiveness aspects of such a possible extension of
data requirements was also emphasized by Member States and the
Commission.
The Council instructed its preparatory bodies to examine in
greater detail these issues while, besides considerations of human
health and environment, taking into account the impact of REACH on
competitiveness, in particular of SMEs, as well as a simplification
of the administrative processes and an efficient use of scarce
resources.
- council
- Competitiveness (Internal Market, Industry, Research and Space)
- date
- 2004-11-25
- type
- Council Meeting
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The Council held a policy debate on a draft Regulation and a
draft Directive on registration, evaluation, authorisation and
restriction of chemicals (REACH) and establishing a European
Chemicals Agency.
The debate was aimed at providing general guidance for further
work. At the end of the debate, the Presidency summarised as
follows:
- As regards the Workshop on REACH Impact Assessment held in The
Hague from 25 to 27 October 2004, the President noted that the
Council welcomed the conclusions and recommendations and instructed
its preparatory bodies, in cooperation with the Commission, to take
account of them in their future work. The Council stressed the
importance of avoiding unnecessary testing on animals and
underlined the need to improve the protection of human health and
the environment while ensuring the competitiveness of the European
chemicals industry, in particular of SMEs.
- On priority-setting in registration, the importance of
examining further options in this field was stressed, in particular
by addressing substances of very high concern at an early stage.
The necessity to explore workable, cost-effective solutions
providing sufficient flexibility, while not overburdening the
registration phase and providing a level of certainty for industry,
was underlined. With this in mind, delegations considered it
appropriate to explore a possible extension of priority-setting in
the registration phase with the inclusion of potential PBTs and
vPvBs.
The Council noted that a risk-based approach, whilst difficult
to apply at registration, might be appropriate for subsequent
phases of REACH and that should be further analysed. There was
general recognition of the need for flexibility, ensuring that in
the future appropriate priority is given to emerging or new
concerns.
- The need to regulate substances in finished articles was
recognised by some delegations but doubts were expressed as to the
workability and the effect on competitiveness of the Commission's
proposal in this field.
Some concern was expressed regarding the registration of
dangerous substances intended and/or likely to be released from
articles. It was considered to focus on articles containing
substances of very high concern in the early stages of REACH.
Concerns were also expressed regarding EU produced articles that
might suffer competitive disadvantages compared to importers of
articles into the EU. The Council noted the idea of professional
customers' "right to know"with regards to dangerous substances in
articles as well as a possible role for the Agency in making
relevant information available.
- council
- Environment
- date
- 2004-12-20
- type
- Council Meeting
-
- date
- 2005-02-17
- docs
-
- type
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- PE353.579
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-
- date
- 2005-03-07
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- Competitiveness (Internal Market, Industry, Research and Space)
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The Council held a policy debate on the state of play
regarding the draft Regulation concerning the Registration,
Evaluation, Authorisation and Restriction of Chemicals (REACH),
establishing a European Chemicals Agency. The debate ranged over a
whole series of issues such as the role of the Agency in the
evaluation of dossiers and substances - particularly as regards
cooperation between the Agency and the Member States - and the
conclusions to be drawn from the work on the REACH impact
analyses.
The Council reiterated its intention to take forward
the REACH proposal with a view to reaching a political agreement
following on from the European Parliament's opinion.
As for the evaluation of dossiers, debate within the
Council confirmed the broadly positive attitude to the enhanced
role of the Agency but reiterated the importance of retaining
national capability to respond to challenges and of retaining
capability to evaluate substances likely to constitute a risk to
health and/or the environment. In this context, the Council calls
on its preparatory bodies to consider the possible consequences of
the alternative proposals with the same rigour as that applied to
the analysis of the Commission proposal - also in terms of
Community resources required to implement them.
As regards the outcome of the REACH workshop,
organised by the Luxembourg Presidency, the Council considers that
the impact studies conducted hitherto have produced sufficient
knowledge to enable negotiations to continue on the basis of the
Commission proposal with a view to producing a feasible
system.
The Council calls on its preparatory bodies to
continue their negotiations on all aspects of the Commission
proposal while taking due account of the impact of the new
legislation on SMEs, on producers/importers of low-volume
substances and on the international competitiveness of European
industry.
Lastly, the Council is determined to take account of
all the results obtained from impact studies when it takes a
political decision.
- council
- Competitiveness (Internal Market, Industry, Research and Space)
- date
- 2005-06-06
- type
- Council Meeting
-
- body
- CSL
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Pending the opinion of the European Parliament, the
Council held a policy debate on a draft Regulation and Directive
concerning the registration, evaluation, authorisation and
restriction of chemicals (REACH), and establishing a European
Chemicals Agency, with a view to setting out general guidelines for
future work.
The discussion concentrated on the authorisation
regime, and in particular on:
-
the scope of authorisation;
-
the possible preparation of a list of chemicals of concern subject
to authorisation;
-
mandatory taking into account of technically and economically
viable alternatives (substances or technologies);
-
the conditions to which, where appropriate, authorisation would be
subject (time-limits, review periods, monitoring).
At the close of the discussion, the Presidency
summarised as follows:
As regards the scope of authorisation, the discussion
in the Council highlighted the importance of applying scientific
and technical criteria when taking account of chemicals of concern
with serious and irreversible effects equivalent to carcinogens,
mutagens or substances toxic to reproduction, and persistent,
bioaccumulative and toxic substances (PBT) or very persistent and
very bioaccumulable substances (vPvB).
While reiterating the need for a manageable and
practicable authorisation regime, the policy debate confirmed the
largely positive attitude towards drawing up a list of chemicals
that would require authorisation.
With regard to taking account of technically and
economically viable alternative technologies or substances in the
context of granting authorisation, the discussion revealed that the
authorization regime was an important part of REACH that could help
replace chemicals of concern, and that the aim was to further
encourage consideration of these alternative solutions before a
decision was taken.
While recognising the merits of encouraging the
development of alternative solutions, the discussion in the Council
emphasised the importance of taking account of the specific
constraints in production cycles when applying conditions to
authorisation, yet without excluding authorization being subject to
strict conditions, including time-limits, review periods and
monitoring conditions.
Lastly, the Council called on its preparatory bodies
to continue negotiations with a view to a political agreement, once
the European Parliament's opinion was available, on all aspects of
the Commission proposal, while taking account of the need to strike
a balance between the international competitiveness of European
industry and environmental and health protection.
It will be recalled that the Competitiveness Council
on 6 and 7 June 2005 addressed the subject of the role of the
European Chemicals Agency and the outcome of the in-depth analysis
of the impact of REACH.
The Community chemicals policy aims at avoiding
chemical contamination of air, water, soil and the human
environment in order to preserve biodiversity and to safeguard
workers' and citizens' health and safety. This policy seeks to
balance health and environmental benefits with the need to sustain
a competitive, innovative and job-creating European industry and
the proper functioning of the internal market.
- council
- Environment
- date
- 2005-06-24
- type
- Council Meeting
-
- date
- 2005-07-13
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- title
- CES0850/2005
- type
- Economic and Social Committee: opinion, report
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- OJ C 294 25.11.2005, p. 0038-0044
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- date
- 2005-10-04
- text
The committee adopted the report by
Guido SACCONI (PES, IT) approving the proposal under the 1st
reading of the codecision procedure, subject to just three
amendments:
- the scope of the directive should be
extended to include articles that contain dangerous substances;
- a requirement should be introduced to affix
a label with a warning symbol on articles containing dangerous
chemical substances, in order to make those articles safer for use
by consumers;
- the provisions of the amended directive
should only start to apply in 18 months' time, given that the
current regime will have to be applied until it becomes obligatory
to register under the REACH regulation.
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- 2003-12-16
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- PSE
- name
- KUCKELKORN Wilfried
-
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- responsible
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- ECON
- date
- 2004-09-23
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- rapporteur
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- group
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- HASSI Satu
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- ECON
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- text
Se fondant sur un
rapport de la présidence, le Conseil a eu un débat
d'orientation sur un certain nombre d'aspects essentiels du projet
de règlement concernant l'enregistrement,
l'évaluation et l'autorisation des substances chimiques,
ainsi que les restrictions applicables à ces substances
(REACH), et instituant une Agence européenne des produits
chimiques. Il a abordé plus particulièrement les
points relatifs aux exigences en matière d'informations lors
de l'enregistrement des substances chimiques et à
l'échange de données entre déclarants.
À la lumière de ce débat, le Conseil a
demandé au Coreper d'examiner plus en détail les
points en question, afin de parvenir à un accord politique
sur REACH lors de la prochaine session du Conseil.
La
présidence a jugé encourageantes les réactions
positives à la proposition de compromis et la contribution
constructive de toutes les délégations.
Pour ce qui est de l'enregistrement des
substances dont la production se situe entre une et dix tonnes, les
délégations sont largement favorables à une
approche ciblée pour les exigences en matière
d'information, comme proposé par la présidence, y
compris pour les informations supplémentaires visées
à l'annexe V. Certaines délégations
préféreraient que cette approche ne s'applique qu'aux
substances existantes.
Un grand nombre de
délégations sont favorables à un
système dans lequel l'obligation d'établir la
nécessité de fournir des données
complémentaires incomberait au déclarant. Cette
approche n'exclut pas que l'agence puisse être
associée en contribuant aux décisions de
l'industrie.
Pour ce qui est de
l'enregistrement des substances dont la production se situe entre
dix et cent tonnes, il existe un large consensus pour juger
appropriée la proposition visant à réduire les
exigences en matière d'information, même si certaines
délégations se sont déclarées
prêtes à envisager la possibilité de dispenses
en fonction du type d'exposition pour les produits se situant dans
cette fourchette.
Il existe un large
consensus en faveur d'un échange de toutes les
données et de la présentation conjointe des
informations pour les déclarants d'une même substance,
pour autant que l'on continue à réfléchir
à des dispositions visant à ce que cela ne soit pas
trop coûteux pour les entreprises et que les informations
commerciales soient correctement protégées.
- council
- Competitiveness (Internal Market, Industry, Research and Space)
- date
- 2005-10-11
- type
- Council Meeting
-
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The Council held a
policy debate on the draft regulation and directive concerning the
registration, evaluation, authorisation and restriction of
chemicals (REACH), and establishing a European Chemicals Agency,
with a view to preparing the ground for a political agreement on
the dossier at the 28-29 November meeting of the (Competitiveness)
Council.
The REACH proposal
for a new chemicals policy in the EU seeks to ensure a high level
of protection of health and the environment while sustaining a
competitive, innovative and jobcreating European industry and the
proper functioning of the internal market.
The debate was
particularly aimed at indicating whether the broad approach taken
by the Presidency in its efforts to find a compromise takes
adequate account of the views expressed in earlier Council
discussions. It further dealt with 2 questions relating to
substances in articles:
- Should substances
intended to be released from articles be subject to a specific
regime or should they be treated as any other substance or
preparation?
- Should the
requirement to notify potentially dangerous substances in articles
be based on the presence of substances of very high concern or
should there be, in addition, a consideration of exposure?
At the close of the
discussion, the Presidency summarised as follows:
"Overall, the
Presidency is encouraged by the positive response to the compromise
proposal and the constructive contribution of all delegations. This
debate has taken us an important step closer to achieving agreement
on this dossier in November.
It appears to the
Presidency that there is a broad consensus developing around the
Presidency compromise and a recognition that the Presidency has
struck the right balance between reducing the impact of the
proposed Regulation on industry whilst maintaining a high level of
protection of human health and the environment.
Quite a number of
delegations stressed the importance of not shifting this balance
further in the direction of reducing information requirements. It
is important that the Regulation does indeed deliver the required
benefits from having more information on chemicals.
Several delegations
stressed the need to avoid transferring responsibility away from
industry to public authorities. The Presidency considers that this
would not preclude that the Agency could be involved in assisting
industry decisions.
A number of
delegations stressed the importance of a strong authorisation
regime not least in encouraging substitution as much as
possible.
It seems to the
Presidency that there are a number of delegations in favour of a
specific regime for substances intentionally released from
articles.
The Presidency notes
that a number of delegations would favour bringing these
requirements into line with those for substances on their own or in
preparations, particularly by including substances which are not
already known to be dangerous.
It appears to the
Presidency that there is broad consensus around its proposal to
notify substances of very high concern where they are present in
articles.
The Presidency notes
that this would not preclude the possibility of an exemption from
the notification requirement where exposure to humans and the
environment can be excluded.
The Council
instructs the Permanent Representatives Committee to examine the
issues discussed in greater detail with a view to preparing for a
political agreement on REACH at the next session of the
Competitiveness Council at the end of November 2005."
- council
- Environment
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- 2005-10-17
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-
- date
- 2005-11-15
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- date
- 2005-11-17
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- text
The European Parliament adopted a
resolution drafted by Guido SACCONI (PES,
IT) and made a few amendments to the Commission's text. (Please see
the summary of 04/10/2005.)
- type
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-
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-
- date
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- title
- SP(2005)5015
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- Commissioner
- DIMAS Stavros DIMAS Stavros
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The Council held a policy debate on a draft Regulation
on the registration, evaluation, authorisation and restriction of
chemicals, (REACH). It instructed the permanent representatives
committee to examine the remaining issues with a view to enabling
the Council to reach a political agreement at its meeting on 13
December.
The debate was held on the basis of a report from the
Presidency setting out the main outstanding issues, in the light of
the European Parliament's recent opinion during its first reading
of the proposal. The President concluded the debate by noting that
there is broad agreement on many of the key issues including
registration and evaluation. The Council detects that there is a
high degree of convergence between the delegations' positions and a
very clear desire to finalise the Council's position at the
December meeting.
Where there are outstanding points, they relate
principally to the question of authorisation and scope.
Authorisation, being the part of REACH dealing with the most
dangerous chemicals, is therefore of particular concern. Some
delegations expressed the wish to see the requirements for
substituting these chemicals to be strengthened further. They
propose, in particular, that the availability of suitable
alternatives should always be considered in authorisation decisions
and, if these are available, an authorisation should not be
granted.
Several other delegations, on the other hand, as well
as the Commission, consider that, if it can be demonstrated that
the risks from the use of some of these chemicals are adequately
controlled, then it should be possible for industry to continue
using these chemicals under stringent conditions.
Other delegations stressed the importance of clarity
over how the concept of adequate control would apply. On the
question of "Scope", some delegations requested further exemptions
from the registration of specific substances. The Presidency notes
that an early review of the relevant Annexes may provide the best
opportunity for the important issue to be resolved.
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-
- date
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- date
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- 10412/2006
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- Council statement on its position
-
- date
- 2006-06-23
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- text
The Council adopted a common position on the
proposal for a regulation concerning the
registration, evaluation, authorisation and restriction of
chemicals (REACH), and establishing a European Chemicals Agency.
The text of the proposal was revised extensively during discussions
carried out by the Council over the last two years. During this
process, there has been a substantial convergence of views between
the Council and the European Parliament. Accordingly, the Council
has integrated into the common position about 200 of the European
Parliament's amendments, either in full, in part or in
principle.
Recitals:
The Common Position is in line with around 20
amendments by the European Parliament, which correspond to the
approach taken in the legal provisions (Articles and
Annexes).
In addition, it takes on board the spirit of certain
amendments which aim to: introduce a "duty of care" for
manufacturers, importers and downstream users (the amended Article
1 states that chemical substances shall not adversely affect human
health or the environment); ensure the free circulation of goods
while enhancing competitiveness and innovation; emphasise the need
to pay special attention to small and medium-sized enterprises. A
new recital underlines the need to take special account of the
potential impact of REACH on SMEs and the need to avoid any
discrimination against them.
Scope and definitions:
The common position reflects either in full, in principle or in part about 15 of
the Parliament's amendments. The Council has consolidated and
clarified the scope of the regulation as well as clarified certain
exemptions (e.g. for waste, substances used in foods or
feedingstuffs and in certain cases in the interests of defence).
Furthermore, the exemptions from registration for individual
substances listed in Annex IV have not been amended (with the sole
exception of the addition of cellulose pulp) but will be reviewed
by the Commission, together with Annexes I and V, 12 months after
entry into force of REACH. The categories of exemption from
registration listed in Annex V have been amended, particularly in
relation to natural substances such as ores, ore concentrates,
minerals and cement clinker.
With regard to the amendment concerning alloys and
their definition as special preparations, the Council welcomes the
Commission's intention to develop guidance, in close cooperation
with Member States and stakeholders, on the assessment of special
preparations.
Registration:
The common position has integrated about 20 of
the Parliament's amendments. With a view
to including the main elements of the "one substance - one
registration" (OSOR) proposal, the provisions on multiple
registrants of the same substance have been amended. The common
position provides for all manufacturers or importers of the same
substance to submit certain parts of the registration dossier
jointly. However, specific possibilities for opting out of this
obligation have been introduced where there are differences of
opinion between registrants on the selection of data, where joint
submission would entail disproportionate costs and where it would
lead to commercially sensitive information being
exchanged.
Substances that are intentionally released from
articles will in principle be treated like all other substances and
registered according to the phase-in periods of 3, 6 and 11 years.
In addition, producers and importers of articles will notify
substances meeting the criteria for authorisation if they are
contained in those articles above a certain level and if exposure
to humans or the environment cannot be excluded throughout the
life-cycle. Where the Agency considers that there are grounds for
suspecting that a substance is released from articles and that this
release presents a risk to human health or the environment, it may
take decisions requiring producers or importers of articles to
submit a registration.
In relation to information to be submitted at
registration, registrants should be able to apply use and exposure
categories voluntarily. Quality assurance of the registration
dossier on a voluntary basis by an assessor chosen by the
registrant as having appropriate experience would be a
possibility.
The information submitted depending on tonnage, must
be as follows:
-Low volume
phase-in substances (those manufactured or imported in quantities
of between 1 and 10 tonnes per manufacturer or importer per year):
where a phase-in substance in this tonnage range meets simple
criteria highlighting it as potentially of concern, the full Annex
VII information is to be provided by the registrant. In other
cases, only the physicochemical information listed in Section 5 of
Annex VII, together with the information that is available to the
registrant, would need to be provided. As Annex VII will only apply
to a limited number of substances in this tonnage range, the common
position includes additional information requirements in relation
to acute toxicity, biodegradation and algal toxicity. Registrants
of all non-phase-in substances would have to provide the full Annex
VII information.
-Only one test for
reproductive toxicity is proposed for Annex VIII (additional
standard information requirements for substances manufactured or
imported in quantities of 10 tonnes or more per manufacturer or
importer year).
-No significant changes have been introduced to
Annexes IX and X (additional standard information requirements for
substances manufactured or imported in quantities of 100 tonnes or
more and 1000 tonnes or more per manufacturer or importer per year,
respectively). Within 18 months of entry into force, the Commission
will adopt criteria defining what constitutes adequate
justification for omitting certain tests in Annexes VIII-X based on
the exposure scenario(s) developed in the Chemical Safety
Report.
In relation to phase-in substances, the common
position provides for the inclusion in the first phase of
registration of substances that are potentially persistent,
bioaccumulative and toxic (PBT) based on current classification
criteria and manufactured or imported in quantities of over 100
tonnes per manufacturer or importer per year.
With regard to those amendments which aim to reduce the number of animal
tests, the Council fully shares the objective expressed in these
amendments but considers that this objective is taken into
consideration within the framework of Article 13(2) that lays down
that test methods will be revised, as appropriate, to refine,
reduce or replace animal tests. The idea is also acknowledged
within the framework of the OSOR proposal and related amendments
made in Title III regarding data sharing, which should lead to
fewer tests on vertebrate animals.
Lastly, since the risk due to exposure is generally
considered to be relatively low and since it would put too much of
a burden on Small and Medium-sized Enterprises (SMEs), the
amendment introducing a requirement to make a Chemical Safety
Assessment for all substances subject to registration has not been
accepted.
Data-sharing and avoidance of unnecessary
testing:
The common position
takes on 30 of the Parliament's amendments. It provides that potential registrants are obliged to
share information generated from vertebrate animal tests.
Information from non-animal tests must be shared if requested by
another potential registrant. As a general rule, the sharing of
costs will be agreed amongst potential registrants themselves in a
fair, proportionate and non-discriminatory way, particularly in
relation to SMEs.
In cases where the sharing of costs cannot be resolved
amongst potential registrants, a clear and unambiguous provision to
assign costs equally is included. To facilitate data sharing, a
single pre-registration phase starting 12 months after entry into
force of the Regulation and finishing 18 months after the entry
into force of the Regulation has been introduced.
The Common Position does not incorporate the amendment
which would make any summaries or robust study summaries of studies
freely available only 15 years after submission in the framework of
a registration procedure, since this could add to the overall cost
of REACH and has the potential to increase the burden for industry,
particularly SMEs. It also does not take on board two amendments
stipulating that sharing of costs should be proportionate to the
production volume.
Information in the supply chain:
12 amendments made by Parliament are integrated
into the common position. The Council has
included in the text an additional requirement for safety data
sheets to be provided for substances that are persistent,
bioaccumulative and toxic or very persistent and very
bioaccumulative and for certain preparations containing these
substances. The role of distributors in ensuring that information
flows through the supply chain has been clarified. Some changes to
Annex I (General provisions for assessing substances and preparing
chemical safety reports (CSR)) and Annex II (Guide to the
compilation of safety data sheets (SDS)) have been
introduced.
The common position does not include the amendment
providing that workers would be granted access by producers to
information given in the supply chain, since such a responsibility
lies with the employer. The amendment concerning a supplier's
obligation to grant access to information on the substances sold
has not been taken on board, since such a provision should be
subject to the general rules on communication of information up and
down the supply chain.
Downstream users:
The common position clarifies the role of distributors
and downstream users in the supply chain, especially as regards how
manufacturers, importers or downstream users should react to
information on identified uses provided by distributors and/or
downstream users. It also clarifies that downstream users can
participate in a Substance Information Forum (SIEF). It clarifies
the cases in which cases downstream users should conduct a Chemical
Safety Assessment (CSA) and prepare a Chemical Safety Report (CSR),
in particular by setting a minimum threshold of 1 tonne below which
a CSR is not required. The Council has decided to delete Annex Ib
(Chemical Safety Assessments for Preparations) given that the
scientific methodology underpinning this Annex is still being
developed.
Evaluation:
The common position includes 37 of the
Parliament's amendments. the Council has
decided on the approach described below:
-as regards dossier
evaluation, the responsibility (both for checking testing proposals
and for compliance checks) has been transferred to the Agency. The
Agency will be able to decide how best to discharge these
obligations, including the possibility of using external
sources.
-a minimum number of compliance checks should be
performed. This is set in the legislation as 5% of dossiers
received. These checks should focus (although not exclusively) on
dossiers where disagreements come to light between registrants of
the same substance, where dossiers are for a substance that is
listed in the EU-wide rolling plan for evaluation or, in the case
of 1-10 tonne substances, where the full information specified in
Annex VII has not been submitted.
-as regards substance evaluation, a single EU-wide
rolling plan for substance evaluation will be established, prepared
by the Agency with input from the Member States.
-the Agency is responsible for co-ordinating the
substance evaluation process relying on the Member States'
competent authorities to perform the evaluations. Member State
competent authorities can, if appropriate, use expert institutes to
perform the evaluation.
The common position does not reflect the amendments
which would give full responsibility for substance evaluation to
the Agency. The Council considers that the most workable solution
is for the Agency to be responsible for coordinating the substance
evaluation process, relying on the Member States' competent
authorities to perform the evaluations. It has also not accepted
the amendment concerning mandatory consultation of the European
Centre for Validation of Alternative Methods (ECVAM) before
deciding on animal testing.
Authorisation:
The common position takes on board 18 of the
Parliament's amendments. Various
amendments have been included which are designed to strengthen
authorisation whilst ensuring that the provisions are workable. The
scope of authorisation has not been amended, but it has been
clarified. For reasons of increased transparency and to facilitate
planning within industry, a candidate list of substances meeting
the authorisation criteria will be published by the Agency. The
published list will also state which substances are on the Agency's
workplan for inclusion in Annex XIV. Substances will be identified
and placed on the list following a period of public consultation.
Authorisations will be granted where the risks from the use of a
substance are adequately controlled or where it is shown that the
socio-economic benefits outweigh the risks to human health or the
environment arising from the use of the substance and where there
are no suitable alternatives substances or technologies
available.
In order to encourage the development of safer
substitutes, all applications for authorisation will include an
analysis of available alternatives considering their risks and the
technical and economic feasibility of substitution. Furthermore,
all authorisations will be subject to time-limited review periods
and shall normally be subject to monitoring by the holder of the
authorisation. The length of the time-limited review period will be
set on a case-by-case basis. In order to close a potential
loophole, the Agency will consider the need for EU-wide
restrictions on the use of a substance in articles at the time of
inclusion of that substance in Annex XIV.
The text does not include those
amendments which would require mandatory
substitution if suitable alternatives are available.
Restrictions:
7 amendments by Parliament are integrated in
the common position. It provides for a
transition period after REACH comes into force to allow Member
States to update existing national legislation relating to current
restrictions on the marketing and use of chemicals. Furthermore,
clarifications to Annexes XV (Dossiers) and XVI (Socio-economic
analysis) have been made.
Fees and charges:
The Council has introduced a new title making it clear
that the fees and charges to be levied under the regulation shall
be introduced in a Commission Regulation. The new title includes
principles for these fees and charges, including the idea that some
of the Agency's revenue will be forwarded to the Member State
competent authorities responsible for undertaking work as in
compliance with REACH. Lower fees will always be charged to
SMEs.
Agency:
The common position includes 13 amendments made
by Parliament. It clarifies several
points, including the following : each Member States will have one
representative on the Management Board; a clarification of the
procedures for appeal has been included; it has been specified that
the rules governing languages in the Agency should be in accordance
with Regulation No 1/58; the reference to the seat of the Agency in
the REACH Regulation has been deleted; the Agency will get its
funding from contributions from the Community budget, fees paid by
industry, and voluntary contributions from Member
States.
All the amendments stipulating that the Agency should
have overall responsibility for the management of REACH or putting
emphasis on the Agency as the main authority in the field of REACH,
have not been incorporated in the common position.
Classification and labelling:
The common position extends the possibility of
harmonised classification and labelling across the EU for other
endpoints than those proposed by the Commission on a case by case
basis. Pending the Commission's proposal on a Globally Harmonised
System of Classification and Labelling of Chemicals (GHS) and in
line with the Commission's proposal on REACH, it was not considered
appropriate to incorporate the Parliament's
amendments.
Information:
This title has been modified substantially with a view
to bringing its provisions in line with Regulation 1049/2001/EC
regarding public access to documents. The common position provides
that the detailed rules for access to information held by the
Agency should be drawn up by the Agency's Management Board in
accordance with the provisions of the Aarhus Convention and with
Regulation 1049/2001/EC. The common position reflects the amendment
stipulating that Member States, the Agency and the Commission will
submit a report every five years on experiences gained.
It also
reflects in principle the amendment stipulating that the Agency
will publish non-confidential information on the
website.
Competent authorities:
In line with the principle of Parliament's amendment,
a clarification of the text concerning guidelines on how to inform
the general public about risks arising from substances has been
introduced in the common position. The Council has also introduced
the principle of the amendment on special help and advice to SMEs.
The Council considers that Member States helpdesks will be of great
benefit to industry, in particular to SMEs.
Enforcement:
Some clarification of the sanctions regime to be
established by Member States has been introduced. The common
position does not reflect the amendments giving the Forum within
the Agency the task to draw up guidelines on enforcement. However,
the Forum shall identify enforcement strategies as well as best
practice in enforcement. Certain other amendments have not been
incorporated since Member States do not see the need for the Agency
to be involved directly in enforcement of the Regulation and in
drawing up of guidelines on sanctions to be taken as a result of
infringement to it.
Transitional and final provisions:
The common position reflects in principle the
amendment laying down that Member States have the right to maintain
more stringent measures on the protection of workers, human health
and the environment, provided that the area is not harmonised by
the REACH Regulation. Regarding the amendment on the preparation of
the establishment of the Agency, the Commission and the Council
have committed themselves in a joint statement to providing the
necessary support towards setting up of the Agency.
Annexes:
The Council has introduced several
modifications to the annexes and taken into account some 36
amendments made by Parliament.
- type
- Council position published
- title
- 07525/3/2006
-
- url
- http://eur-lex.europa.eu/JOHtml.do?uri=OJ:C:2006:276E:SOM:EN:HTML
- type
- Council position
- title
- OJ C 276 14.11.2006, p. 0252-0254 E
- council
- Environment
- date
- 2006-06-27
- type
- Council Meeting
-
- date
- 2006-07-12
- docs
-
- url
- http://www.europarl.europa.eu/registre/docs_autres_institutions/commission_europeenne/sec/2006/0924/COM_SEC(2006)0924_EN.pdf
- text
Based on the political agreement on a common position
reached by the Council on 13 December 2005, this revised
legislative financial statement replaces the legislative financial
statement presented by the Commission in conjunction with the
'REACH' proposal.
Accompanying the political agreement on the common
position the Commission and Member States made a number of
important declarations. Reflecting the importance of a performing
European Chemicals Agency and the need for it to become fully
operational before critical REACH procedures come into effect, the
Council and the Commission made a joint statement on actions that
are necessary for setting up the Agency. In that context also, the
Commission takes the opportunity to stress the need for adequate
budgetary provision for the increased costs falling on the
Agency.
It should be noted that there is no impact on the
revenue side of the Community budget. The Agency's budget foresees
(i) its own revenues consisting of fees and charges for items such
as registrations, applications for authorisation, production
and process oriented research and design applications, appeal fees,
fees for confidentiality claims, etc. which the Agency is
authorised to collect by virtue of the tasks entrusted to it, and
(ii) a balancing subsidy from the Community budget.
For further information concerning the financial
implications of this measure, please refer to the financial
statement.
- title
- SEC(2006)0924
- type
- Document attached to the procedure
- celexid
- CELEX:52006SC0924:EN
-
- url
- http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2006&nu_doc=0375
- text
The Commission welcomes the
adoption of the common position and considers that the principal
aims of its REACH proposalare safeguarded in it.
In its assessment of Parliament's
first reading text and of the Council's common position on REACH,
the Commission has taken into account the substantial convergence
of the positions of both institutions of the decision making
process regarding the main elements.
The Commission considers that a
suitable balance has been found on the most difficult and the most
critical areas of REACH, namely, registration and authorisation. In
the end all Member States and the Commission, supported the final
compromise proposal that had been developed, having accepted it as
a fair balance between those concerned about the need to provide
greater encouragement to the substitution of dangerous substances
and those concerned about the impact on competitiveness and
investment in Europe. Two of the main elements of the compromise
were: i) applications for authorisations should always include an
analysis of possible alternatives by the registrant and ii) for
substances of very high concern for which it is not possible to
determine safe thresholds with current methods, a review of these
methods should be foreseen within 12 months after entry into force
of the regulation based on work in the REACH implementation
projects.
On other important aspects such
as scope, the Council has addressed Parliament's concerns by
providing for improved exemptions from registration, and by
requiring a review of the annexes governing such exemptions within
12 months of the entry into force of the regulation. On evaluation,
the Council has taken a similar line to the Parliament by
significantly increasing the role of the Agency. The Commission
believes that the Council's approach to access to information and
confidentiality is also consistent with the intentions of
Parliament and strikes the right balance.
The net result is that around 90%
of the European Parliament's amendments to REACH that the
Commission could accept totally, in part or in principle have been
incorporated in the Common Position, using identical or similar
wording. In addition, the political agreement includes 43
amendments which the Commission did not state it could accept. In
addition 38, including 7 relating to persistent organic pollutants
of the amendments where the Commission reserved its position have
also been included.
Central to Parliament's
amendments was a compromise package on registration and
pre-registration, all aspects of which the Commission said that it
could support. Out of 47 amendments constituting this package, 37
are included in principle, in part or in full in the common
position. The Parliament adopted other compromise packages, of
which 96 amendments are included in the common position.
Accompanying the political
agreement on the common position the Commission and Member States
made a number of important declarations. Reflecting the importance
of a performing European Chemicals Agency and the need for it to
become fully operational before critical REACH procedures come into
effect, the Council and the Commission made a joint statement on
actions that are necessary for setting up the Agency. In that
context also, the Commission takes the opportunity to stress the
need for adequate budgetary provision for the increased costs
falling on the Agency. The Commission also made statements on
special preparations (including alloys), on free movement (Article
127(2) of the Regulation), and on Article 56(f) of the Regulation
(in Annex II).
In addition, Denmark and Sweden
made two declarations, jointly with Luxembourg on authorisation,
and jointly with Germany on Article 2(2) of the Regulation. Poland
and Ireland made a joint declaration on authorisation Poland made
one on the effect of REACH on competitiveness and Germany made
declarations on the income that Member States could derive from
fees and on the need for a general discussion on the immunities of
European agencies.
- title
- COM(2006)0375
- type
- Commission communication on Council's position
- celexid
- CELEX:52006PC0375:EN
- body
- EC
- commission
-
- DG
- Enterprise and Industry Environment
- Commissioner
- DIMAS Stavros DIMAS Stavros
- type
- Document attached to the procedure
-
- date
- 2006-09-07
- body
- EP
- type
- Committee referral announced in Parliament, 2nd reading
- committees
-
- body
- EP
- responsible
- True
- committee
- ENVI
- date
- 2004-07-27
- committee_full
- Environment, Public Health and Food Safety
- rapporteur
-
- group
- PSE
- name
- SACCONI Guido
-
- body
- EP
- responsible
- True
- committee
- ENVI
- date
- 2004-07-27
- committee_full
- Environment, Public Health and Food Safety (Associated committee)
- rapporteur
-
- group
- PSE
- name
- SACCONI Guido
-
- body
- EP
- responsible
- True
- committee
- ENVI
- date
- 2003-06-16
- committee_full
- Environment, Public Health, Consumer Policy (Associated committee)
- rapporteur
-
- group
- PSE
- name
- SACCONI Guido
-
- date
- 2006-10-10
- text
The committee adopted the report by Guido SACCONI (PES,
IT) approving the Council's common position unamended under the 2nd
reading of the codecision procedure.
- body
- EP
- committees
-
- body
- EP
- responsible
- True
- committee
- ENVI
- date
- 2004-07-27
- committee_full
- Environment, Public Health and Food Safety
- rapporteur
-
- group
- PSE
- name
- SACCONI Guido
-
- body
- EP
- responsible
- True
- committee
- ENVI
- date
- 2004-07-27
- committee_full
- Environment, Public Health and Food Safety (Associated committee)
- rapporteur
-
- group
- PSE
- name
- SACCONI Guido
-
- body
- EP
- responsible
- True
- committee
- ENVI
- date
- 2003-06-16
- committee_full
- Environment, Public Health, Consumer Policy (Associated committee)
- rapporteur
-
- group
- PSE
- name
- SACCONI Guido
- type
- Vote in committee, 2nd reading
-
- date
- 2006-10-12
- docs
-
- url
- http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A6-2006-0345&language=EN
- type
- Committee recommendation tabled for plenary, 2nd reading
- title
- A6-0345/2006
- body
- EP
- committees
-
- body
- EP
- responsible
- True
- committee
- ENVI
- date
- 2004-07-27
- committee_full
- Environment, Public Health and Food Safety
- rapporteur
-
- group
- PSE
- name
- SACCONI Guido
-
- body
- EP
- responsible
- True
- committee
- ENVI
- date
- 2004-07-27
- committee_full
- Environment, Public Health and Food Safety (Associated committee)
- rapporteur
-
- group
- PSE
- name
- SACCONI Guido
-
- body
- EP
- responsible
- True
- committee
- ENVI
- date
- 2003-06-16
- committee_full
- Environment, Public Health, Consumer Policy (Associated committee)
- rapporteur
-
- group
- PSE
- name
- SACCONI Guido
- type
- Committee recommendation tabled for plenary, 2nd reading
-
- date
- 2006-12-11
- body
- EP
- type
- Debate in Parliament
-
- date
- 2006-12-13
- docs
-
- url
- http://www.europarl.europa.eu/sides/getDoc.do?type=TA&language=EN&reference=P6-TA-2006-0553
- text
The European Parliament adopted a resolution based on
the report by Guido SACCONI (PES, Italy) and approved the Council's common
position.
- type
- Decision by Parliament, 2nd reading
- title
- T6-0553/2006
-
- url
- http://www.europarl.europa.eu/oeil/popups/sda.do?id=12716&l=en
- type
- Results of vote in Parliament
- title
- Results of vote in Parliament
- body
- EP
- type
- Text adopted by Parliament, 2nd reading
-
- date
- 2006-12-18
- body
- type
- Final act signed
-
- date
- 2006-12-18
- body
- EP
- type
- End of procedure in Parliament
-
- date
- 2006-12-30
- text
PURPOSE: Corrigendum to Directive 2006/121/EC
of the European Parliament and of the Council of 18 December 2006
amending Council Directive 67/548/EEC on the approximation of laws,
regulations and administrative provisions relating to the
classification, packaging and labelling of dangerous substances in
order to adapt it to Regulation (EC) No 1907/2006 concerning the
Registration, Evaluation, Authorisation and Restriction of
Chemicals (REACH) and establishing a European Chemicals Agency
(Official Journal of the European Union L 396 of 30 December
2006).
The aims of the REACH Regulation are to ensure
a high level of protection of health and the environment as well as
the free circulation of substances on the internal market while
enhancing competitiveness and innovation (see COD/2003/0256). The aim of the Directive is to amend
67/548/EEC in line with the changes to the current chemicals
management regime introduced by REACH. In relation to the adoption
of Regulation 1907/2006/EC, Directive 67/548/EEC has been
adapted and its rules on the notification and risk assessment of
chemicals have been deleted.
The
Corrigendum concerns the entire text of the Directive.
- type
- Final act published in Official Journal
- docs
-
- url
- http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!CELEXnumdoc&lg=EN&numdoc=32006L0121
- title
- Directive 2006/121
-
- url
- http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2006:396:SOM:EN:HTML
- title
- OJ L 396 30.12.2006, p. 0850
-
- url
- http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexapi!prod!CELEXnumdoc&lg=EN&model=guicheti&numdoc=32006L0121R(01)
- title
- Corrigendum to final act 32006L0121R(01)
-
- url
- http://eur-lex.europa.eu/JOHtml.do?uri=OJ:L:2007:136:SOM:EN:HTML
- title
- OJ L 136 29.05.2007, p. 0281
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