TITLE XV
TRANSITIONAL AND FINAL PROVISIONS
1.
Subject to paragraph 2, Member States shall not prohibit, restrict or
impede the manufacturing, import, placing on the market or use of a substance,
on its own, in a preparation or in an article, falling within the scope of this
Regulation, which complies with this Regulation and, where appropriate, with
Community acts adopted in implementation of this Regulation.
2.
Nothing in this Regulation shall prevent Member States from maintaining
or laying down national rules to protect workers, human health and the
environment applying in cases where this Regulation does not harmonise the
requirements on manufacture, placing on the market or use.
1.
Where a Member State has justifiable grounds for believing that urgent
action is essential to protect human health or the environment in respect of a
substance, on its own, in a preparation or in an article, even if satisfying
the requirements of this Regulation, it may take appropriate provisional
measures. The Member State shall immediately inform the Commission, the Agency
and the other Member States thereof, giving reasons for its decision and
submitting the scientific or technical information on which the provisional
measure is based.
2.
The Commission shall take a decision in accordance with the procedure
referred to in Article 133(3) within 60 days of receipt of the information from
the
(a)
authorise
the provisional measure for a time period defined in the decision; or
(b)
require the Member State to revoke the provisional
measure.
3.
If, in the
case of a decision as referred
to in paragraph 2(a), the
provisional measure taken by the Member
State consists in a restriction on the placing on the market or use of a substance,
the Member State concerned shall initiate a Community restrictions
procedure by submitting to the Agency a dossier, in
accordance with Annex XV, within three months
of the date of the
Commission decision.
4.
In the
case of a decision as referred
to in paragraph 2(a), the
Commission shall consider whether this Regulation
needs to be adapted.
Article 130
Statement of reasons for decisions
The competent
authorities, the Agency and the
Commission shall state the reasons for all decisions they take under
this Regulation.
Article 131
Amendments to the Annexes
The Annexes may
be amended in accordance with the procedure
referred to in Article 133(4).
Implementing
legislation
The measures
necessary to put the provisions of this Regulation efficiently into effect shall
be adopted in accordance with the procedure
referred to in Article 133(3).
Article 133
Committee procedure
1.
The Commission shall be assisted by a Committee.
2.
Where reference is made to this paragraph, Articles 3 and 7 of Decision
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
3.
Where reference is made to this paragraph, Articles 5 and 7 of Decision
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
4.
The period laid down in Article 5(6) of Decision
1999/468/EC shall be set at three months.
5.
Where reference is made to this paragraph, Article 5a (1) to (4), and
Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions
of Article 8 thereof.
6.
The Committee shall adopt its Rules of Procedure.
Preparation
of establishment of the Agency
1.
The
Commission shall afford the necessary support towards the establishment of the Agency.
2.
For that purpose, until such time as the Executive Director takes up his
duties following his appointment by the Management Board of the Agency in
accordance with Article 84, the Commission, on behalf of the Agency, and using
the budget provided for the latter, may
(a)
appoint personnel, including a person who shall fulfil
the administrative functions
of the Executive Director on an interim basis; and
(b)
conclude
other contracts.
Article 135
Transitional measures regarding notified substances
1.
The requests to notifiers to provide further
information to the competent authority in accordance with Article 16(2) of
Directive 67/548/EEC, shall be considered as decisions
adopted in accordance with Article 51 of this Regulation.
2.
The requests to a notifier to provide further
information for a substance in accordance with Article 16(1) of Directive
67/548/EEC, shall be considered as decisions adopted
in accordance with Article 52 of this Regulation.
Such substance shall be regarded as being
included in the Community rolling action plan in accordance with Article 44(2)
of this Regulation and shall be regarded as being chosen in accordance with
Article 45(2) of this Regulation by the Member State whose competent authority
has requested further information in accordance with Article 7(2) and Article
16(1) of Directive 67/548/EEC.
Article 136
Transitional measures regarding existing substances
1.
The requests to manufacturers and importers to submit information to the
Commission made by a Commission Regulation in application of Article 10(2) of
Regulation (EEC) No 793/93, shall be considered as
decisions adopted in accordance with Article 52 of this Regulation.
The competent authority for the substance shall
be the competent authority from the
2.
The requests to manufacturers and importers to submit information to the
Commission made by a Commission Regulation in
application of Article 12(2) of Regulation (EEC) No
793/93, shall be considered as decisions adopted in accordance with
Article 52 of this Regulation.
The Agency shall identify the competent authority
for the substance to carry out the
tasks of Article 46(3) and
Article 48 of this Regulation.
3.
A Member
State whose rapporteur has not forwarded
by 1 June 2008 the risk evaluation and, where appropriate,
the strategy for limiting the risks,
in accordance with Article 10(3) of Regulation (EEC) No 793/93, shall:
(a)
document information on hazard and risk
in accordance with Annex XV, Part B of this Regulation;
(b)
apply
Article 69(4) of this Regulation
on the basis of the
information referred to in point (a); and
(c)
prepare
a documentation of how it considers
that any other risks identified
would need to be addressed by action other than an amendment
of Annex XVII of this Regulation.
The information referred to above
shall be submitted to the Agency by
Transitional
measures regarding restrictions
1.
By 1 June
2010, the Commission shall,
if necessary, prepare a draft amendment to Annex XVII in accordance with either of the following:
(a)
any risk evaluation and recommended strategy for limiting risks that has been adopted at Community
level in accordance with
Article 11 of Regulation (EEC) No 793/93 as far as it includes proposals
for restrictions in accordance with Title VIII of this Regulation but for which a decision under Directive
76/769/EEC has not yet been taken;
(b)
any proposal, which has been submitted to the relevant
institutions but has not yet been adopted,
concerning the introduction
or the amendment of
restrictions under Directive 76/769/EEC.
2.
Until
3.
Any amendment to the restrictions adopted under Directive 76/769/EEC from
Review
1.
By 1 June
2019, the Commission shall
carry out a review to assess
whether or not to extend the application of the obligation
to perform a chemical safety assessment and to document it in a chemical safety report to
substances not covered by this
obligation because they are not subject
to registration or subject to registration but manufactured or imported in quantities of less than 10 tonnes per year. However, for substances
meeting the criteria for
classification as carcinogenic, mutagenic
or toxic for reproduction, category
1 or 2, in accordance with Directive 67/548/EEC, the review shall
be carried out by 1 June 2014. When carrying out the review the Commission shall take into
account all relevant factors,
including:
(a)
the costs for manufacturers and importers of drawing up the chemical safety reports;
(b)
the
distribution of costs between
actors in the supply chain and
the downstream user;
(c)
the benefits for human health and the
environment.
On the basis of these reviews, the Commission
may, if appropriate, present legislative proposals to extend this obligation.
2.
The Commission may present legislative proposals as soon as a
practicable and cost-efficient way of selecting polymers for registration on
the basis of sound technical and valid scientific criteria can be established,
and after publishing a report on the following:
(a)
the risks posed by polymers in comparison with other substances;
(b)
the need, if any, to register certain types of polymer,
taking account of competitiveness and innovation on
the one hand and the protection of human health and the
environment on the other.
3.
The report, referred to in Article 117(4), on the experience acquired
with the operation of this Regulation shall include a review of the
requirements relating to registration of substances manufactured or imported
only in quantities starting at one tonne but less than 10 tonnes per year per
manufacturer or importer. On the basis of that review, the
Commission may present legislative proposals to modify the information requirements for substances manufactured
or imported in quantities
of one tonne or more up to 10 tonnes per year per manufacturer or
importer, taking into account the latest
developments, for example
in relation to alternative testing and (quantitative) structure-activity
relationships ((Q)SARs).
4.
The Commission shall carry out a review of Annexes I, IV and V by
5.
The Commission shall carry out a review of Annex XIII by
6.
By
7.
By
8.
By
9.
In accordance with the objective of promoting non-animal testing and the
replacement, reduction or refinement of animal testing required under this Regulation,
the Commission shall review the testing requirements of Section 8.7 of Annex
VIII by
Directive 91/155/EEC shall be repealed.
Directives
93/105/EC and 2000/21/EC and Regulations (EEC) No 793/93 and (EC) No 1488/94 shall be repealed with effect from
Directive
93/67/EEC shall be repealed with effect from
Directive
76/769/EEC shall be repealed with effect from 1 June 2009.
References
to the repealed acts shall be construed as references to this Regulation.
Article 140
Amendment of Directive 1999/45/EC
Article 14 of Directive 1999/45/EC shall
be deleted.
Article 141
Entry into force and application
1.
This Regulation shall enter into force on
2.
Titles II, III, V, VI, VII, XI and XII as well as Articles 128 and 136 shall apply from
3.
Article 135 shall
apply from 1 August 2008.
4.
Title
VIII and Annex XVII shall apply from
1 June 2009.
This
Regulation shall be binding in its entirety and directly applicable in all
Member States.
Done at
Brussels, 18 December 2006.