RESTRICTIONS ON THE
MANUFACTURING,
PLACING ON THE MARKET AND USE
OF
CERTAIN DANGEROUS SUBSTANCES,
PREPARATIONS AND ARTICLES
1.
A substance on its own, in a preparation or in an article, for which
Annex XVII contains a restriction shall not be manufactured, placed on the
market or used unless it complies with the conditions of that restriction. This
shall not apply to the manufacture, placing on the market or use of a substance
in scientific research and development. Annex XVII shall specify if the
restriction shall not apply to product and process orientated research and
development, as well as the maximum quantity exempted.
2.
Paragraph 1 shall not apply to the use of substances in cosmetic
products, as defined by Directive 76/768/EEC, with regard to restrictions
addressing the risks to human health within the scope of that Directive.
3.
Until
CHAPTER 2
Restrictions process
Article 68
Introducing new and amending current restrictions
1.
When there is an unacceptable risk to human health or the environment,
arising from the manufacture, use or placing on the market of substances, which
needs to be addressed on a Community-wide basis, Annex XVII shall be amended in
accordance with the procedure referred to in Article 133(4) by adopting new
restrictions, or amending current restrictions in Annex XVII, for the
manufacture, use or placing on the market of substances on their own, in
preparations or in articles, pursuant to the procedure set out in Articles 69 to 73. Any such decision shall take into account the socio-economic
impact of the restriction, including the availability of alternatives.
The first subparagraph shall not apply to the
use of a substance as an on-site isolated intermediate.
2.
For a substance on its own, in a preparation or in an article which
meets the criteria for classification as carcinogenic, mutagenic or toxic to
reproduction, category 1 or 2, and could be used by consumers and for which
restrictions to consumer use are proposed by the Commission, Annex XVII shall
be amended in accordance with the procedure referred to in Article 133(4). Articles
69 to 73 shall not apply.
Article 69
Preparation of a proposal
1.
If the Commission considers that the manufacture, placing on the market
or use of a substance on its own, in a preparation or in an article poses a
risk to human health or the environment that is not adequately controlled and
needs to be addressed, it shall ask the Agency to prepare a dossier which
conforms to the requirements of Annex XV.
2.
After the date referred to in Article 58(1)(c)(i) for a substance listed
in Annex XIV, the Agency shall consider whether the use of that substance in
articles poses a risk to human health or the environment that is not adequately
controlled. If the Agency considers that the risk is not adequately
controlled, it shall prepare a dossier which conforms to the requirements of
Annex XV.
3.
Within 12 months of the receipt of the request from the Commission in
paragraph 1 and if this dossier demonstrates that action on a Community-wide
basis is necessary, beyond any measures already in place, the Agency shall
suggest restrictions, in order to initiate the restrictions process.
4.
If a Member State considers that the manufacture, placing on the market
or use of a substance on its own, in a preparation or in an article poses a
risk to human health or the environment that is not adequately controlled and
needs to be addressed it shall notify the Agency that it proposes to prepare a
dossier which conforms to the requirements of the relevant sections of Annex XV.
If the substance is not on the list maintained by the Agency referred to in
paragraph 5 of this Article, the
The Agency or Member States shall
refer to any dossier, chemical safety report or risk assessment submitted to
the Agency or Member State under this Regulation. The Agency or Member States
shall also refer to any relevant risk assessment submitted for the purposes of
other Community Regulations or Directives. To this end other bodies, such as
agencies, established under Community law and carrying out a similar task shall
provide information to the Agency or Member State concerned on request.
The Committee for Risk Assessment
and the Committee for Socio-economic Analysis shall check whether the dossier
submitted conforms to the requirements of Annex XV. Within 30 days of receipt,
the respective Committee shall inform the Agency or the Member State suggesting
restrictions, as to whether the dossier conforms. If the dossier does not
conform, the reasons shall be given to the Agency or the Member State in
writing within 45 days of receipt. The Agency or the Member State shall bring
the dossier into conformity within 60 days of the date of receipt of the
reasons from the Committees, otherwise the procedure under this Chapter shall
be terminated. The Agency shall publish without delay the intention of the
Commission or of a Member State to instigate a restriction procedure for a
substance and shall inform those who submitted a registration for that
substance.
5.
The Agency shall maintain a list of substances for which a dossier
conforming to the requirements of Annex XV is planned or underway by either the
Agency or a
6.
Without prejudice to Articles 118 and 119, the Agency shall make
publicly available on its website all dossiers conforming with
Annex XV including the restrictions suggested pursuant to paragraphs 3 and 4 of
this Article without delay, clearly indicating the date of publication. The
Agency shall invite all interested parties to submit individually or jointly
within 6 months of the date of publication:
(a)
comments on dossiers and the
suggested restrictions;
(b)
a socio-economic analysis, or
information which can contribute to one, of the suggested restrictions,
examining the advantages and drawbacks of the proposed restrictions. It shall
conform to the requirements in Annex XVI.
Article 70
Agency opinion: Committee for Risk Assessment
Within nine months of the date of publication referred to in Article 69(6), the Committee for Risk Assessment shall formulate an opinion as to whether the suggested restrictions are appropriate in reducing the risk to human health and/or the environment, based on its consideration of the relevant parts of the dossier. This opinion shall take account of the Member State dossier or of the dossier prepared by the Agency at the request of the Commission, and the views of interested parties referred to in Article 69(6)(a).
Agency opinion: Committee for Socio-economic
Analysis
1.
Within 12 months of the date of publication referred to in Article
69(6), the Committee for Socio-economic Analysis shall formulate an opinion on
the suggested restrictions, based on its consideration of the relevant parts of
the dossier and the socio-economic impact. It shall prepare a draft
opinion on the suggested restrictions and on the related socio-economic impact,
taking account of the analyses or information according to Article
69(6)(b), if there are any. The Agency shall publish the draft opinion on its
website without delay. The Agency shall invite interested parties to give their
comments on the draft opinion no later than 60 days from the publication of
that draft opinion.
2.
The Committee for Socio-economic Analysis shall without delay adopt its
opinion, taking into account where appropriate further comments received by the
deadline set. This opinion shall take account of the comments and
socio-economic analyses of interested parties submitted under Article 69(6)(b) and under paragraph 1 of this Article.
3.
Where the opinion of the Committee for Risk Assessment diverges significantly
from the restrictions suggested, the Agency may postpone the deadline for the
opinion of the Committee for Socio-economic Analysis by a maximum of 90 days.
Submission of an opinion to the Commission
1.
The Agency shall submit to the Commission
without delay the opinions of the Committees for Risk Assessment and
Socio-economic Analysis on restrictions suggested for substances on their own,
in preparations or in articles. If one or both of the Committees do not
formulate an opinion by the deadline set in Article 70 and Article 71(1) the
Agency shall inform the Commission accordingly, stating the reasons.
2.
Without prejudice to Articles 118 and 119 the Agency shall publish the
opinions of the two Committees on its website without delay.
3.
The Agency shall provide the Commission and/or
Article 73
Commission decision
1.
If the conditions laid down in Article 68 are fulfilled, the Commission
shall prepare a draft amendment to Annex XVII, within three months of receipt
of the opinion of the Committee for Socio-economic Analysis or by the end of
the deadline established under Article 71 if that Committee does not form an
opinion, whichever is the earlier.
Where the draft amendment diverges from the
original proposal or if it does not take the opinions from the Agency into
account, the Commission shall annex a detailed explanation of the reasons for
the differences.
2.
A final decision shall be taken in accordance with the procedure
referred to in Article 133(4). The Commission shall send the draft amendment
to the Member States at least 45 days before voting.