25 March 2005
Page 1 of 11
Proposal for a
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),
establishing a European Chemicals Agency and amending Directive 1999/45/EC and
Regulation (EC) {on Persistent Organic Pollutants}
COM(2003) 644 final
2003/0256(COD)
Amendments proposed by the DUCC
Text of the Commission
Amendment 1
(Please underline the deleted text)
(Underline the added or amended text)
Article 1, paragraph 3
Article 1, paragraph 3
Subject-matter
Subject-matter
This Regulation is based on the principle
that it is up to manufacturers, importers and
downstream users to ensure that they
manufacture, place on the market, import
or use such substances that do not
adversely affect human health or the
environment. Its provisions are
underpinned by the precautionary principle.
This Regulation is based on the principle
that it is up to manufacturers, importers and
downstream users to ensure that they
manufacture, place on the market, import
or use such substances that do not
adversely affect human health or the
environment under normal or reasonably
foreseeable conditions of use. Its
provisions are underpinned by the
precautionary principle.
Justification
The new wording is consistent with the definition of “safe product” as defined in the
General Product Safety Directive (2001/95/EEC).
This is indeed essential, as it indicates the frame and the limits to which the subject of this
Regulation applies.
DUCC Amendments to Commission REACH Proposal
25 March 2005
Page 2 of 11
Text of the Commission
Amendment 2
(Please underline the deleted text)
(Underline the added or amended text)
Article 3, paragraph 26
Article 3, paragraph 26
Definitions
Definitions
Undesirable use means a use by
downstream users which the registrant
advises against;
Unsupported use means a use by
downstream users which the registrant
advises against for safety reasons;
Justification
-
The words “undesirable use” have an emotional rather than scientific or legal
connotation, which is unsuitable in a legislation.
Registrant should have the right to advice against uses they consider unsafe but not
against uses they do not wish to register, for example for economical reasons.
DUCC Amendments to Commission REACH Proposal
25 March 2005
Page 3 of 11
Text of the Commission
Amendment 3
(Please underline the deleted text)
(Underline the added or amended text)
Article 5, paragraph 1bis (new)
Article 5, paragraph 1bis (new)
General obligation to register
substances on their own or in
preparations
General obligation to register
substances on their own or in
preparations
A registration to the Agency shall not be
performed for a substance which is present
in a preparation at a concentration less
than the lowest of any of the following:
a) the
applicable
concentrations
defined in the table of article 3 (3) of
directive 1999/45/EC;
b) the concentration limits given in
annex I to directive 67/548/EEC;
c) the concentration limits given in Part
B of Annex II to Directive
1999/45/EC;
d) the concentration limits given in Part
B of Annex III to Directive
1999/45/EC;
e) the concentration limits given in an
agreed entry in the classification and
labelling inventory established under
Title X;
f) 0.1 %, if the substance meets the
criteria in annex XII.
Justification
This Amendment is required for several reasons:
1. To be consistent with the same requirement made in article 13.(2) for chemical
safety report on substances present in preparations.
2. In the absence of such limits, importers will have to analyse each preparation down
to the lowest level or obtain the exact composition from their suppliers which is not
feasible.
3. Additionally, such requirements placed on importers could lead to a WTO issue.
DUCC Amendments to Commission REACH Proposal
25 March 2005
Page 4 of 11
Text of the Commission
Amendment 4
(Please underline the deleted text)
(Underline the added or amended text)
Article 9.1
Article 9.1
Information to be submitted for general
registration purposes
Information to be submitted for general
registration purposes
a chemical safety report when required
under Article 13.
a chemical safety report when required
under Article 13. This may be incorporated
in a Safety Data Sheet and generic
exposure categories may be used to report
exposure conditions.
Justification
To facilitate control and simplify the workload of the whole EU industry, an extended SDS
could be sufficient as a Chemical Safety report. Additionally, regarding the exposure
conditions, simple categories of exposure should be defined for potential use by
downstream users.
DUCC Amendments to Commission REACH Proposal
25 March 2005
Page 5 of 11
Text of the Commission
Amendment 5
(Please underline the deleted text)
(Underline the added or amended text)
Article 9.2 (new)
Article 9.2 (new)
Information to be submitted for general
registration purposes
Information to be submitted for general
registration purposes
Information required in paragraph 1 and
generated under other EU or international
legislation and or chemicals programmes
may be submitted in their original format.
Justification
To reduce unnecessary administrative tasks and make REACH more workable, data which
have been already collected on a certain number of substances under other EU or
international programmes/legislations could be submitted as such and it should not be
required to modify the dossier according to the REACH format.
DUCC Amendments to Commission REACH Proposal
25 March 2005
Page 6 of 11
Text of the Commission
Amendment 6
(Please underline the deleted text)
(Underline the added or amended text)
Article 25, paragraph 5
Article 25, paragraph 5
Sharing of existing data between
registrants
Sharing of existing data between
registrants
5. The previous registrant(s) shall have 1
month from the receipt of the information
referred to in paragraph 4 to inform the
potential registrant and the Agency of the
cost incurred by him for the study
concerned. At the request of the potential
registrant, the Agency shall take the
decision to make available to him the
summaries or robust study summaries, as
the case may be, of the studies concerned,
or the results thereof, on receipt of proof
that he has paid the previous registrant(s)
50% of the cost shown by the latter.
5. The previous registrant(s) shall have 1
month from the receipt of the information
referred to in paragraph 4 to inform the
potential registrant and the Agency of the
cost incurred by him for the study
concerned. At the request of the potential
registrant, the Agency shall take the
decision to make available to him the
summaries or robust study summaries, as
the case may be, of the studies concerned,
or the results thereof, on receipt of proofs
that he has paid the previous registrant(s)
an equal share of the cost shown by the
latter.
Justification
The new registrant should not pay 50% of the testing cost to previous registrant(s) as it is
currently proposed for “non-phase-in” substances because:
1. Rules of cost sharing for “non-phase-in” substances should be the same as for
“phase-in” (see Article 28 (3)). There are no reason to have a different cost sharing
systems between these two types of substances.
2. It is not normal that every potential registrant of non-phase-in substances pay 50%
of the original testing costs irrespective of the number of potential or previous
registrants.
DUCC Amendments to Commission REACH Proposal
25 March 2005
Page 7 of 11
Text of the Commission
Amendment 7
(Please underline the deleted text)
(Underline the added or amended text)
Article 25, paragraph 6
Article 25, paragraph 6
Sharing of existing data between
registrants
Sharing of existing data between
registrants
6. If the previous registrant(s) fail(s) to
inform the potential registrant and the
Agency of the cost within the deadline set
in paragraph 5, the Agency, on request,
shall take the decision to make available to
the potential registrant the summaries or
robust study summaries, as the case may
be, of the studies concerned as required by
him. The previous registrant(s) shall have a
claim on the potential registrant for 50% of
the cost, which shall be enforceable in the
national courts.
6. If the previous registrant(s) fail(s) to
inform the potential registrant and the
Agency of the cost within the deadline set
in paragraph 5, the Agency, on request,
shall take the decision to make available to
the potential registrant the summaries or
robust study summaries, as the case may
be, of the studies concerned as required by
him. The previous registrant(s) shall have a
claim on the potential registrant for an
equal share of the cost, which shall be
enforceable in the national courts
Justification
3. Linked to the amendment to Article 25, paragraph 5
DUCC Amendments to Commission REACH Proposal
25 March 2005
Page 8 of 11
Text of the Commission
Amendment 8
(Please underline the deleted text)
(Underline the added or amended text)
Article 27, paragraph 1
Article 27, paragraph 1
Substance Information Exchange Fora
Substance Information Exchange Fora
All manufacturers and importers who have
submitted information to the Agency in
accordance with Article 26 for the same
phase-in substance shall be participants in
a substance information exchange forum
(SIEF).
All manufacturers, importers and
downstream users who have submitted
information to the Agency in accordance
with Article 26 for the same phase-in
substance shall be participants in a
substance information exchange forum
(SIEF).
Justification
Downstream Users should have access to SIEF to share hazard & exposure data.
DUCC Amendments to Commission REACH Proposal
25 March 2005
Page 9 of 11
Text of the Commission
Amendment 9
(Please underline the deleted text)
(Underline the added or amended text)
Article 30, paragraph 1
Article 30, paragraph 1
Duty to communicate information down
the supply chain for substances and
preparations for which a safety data
sheet is not required
Duty to communicate information down
the supply chain for substances and
preparations for which a safety data
sheet is not required
All actors in the supply chain of a
substance on its own or in a preparation
who do not have to supply a safety data
sheet in accordance with Article 29 shall
communicate the following information
down the supply chain to the immediate
downstream user or distributor:
(a) the registration number(s) referred to
in Article 18 (1), if available;
(b) whether the substance is subject to
authorisation and details of any
authorisation granted or denied
under Title VII in this supply chain;
(c) details of any restriction imposed
under Title VIII;
(d) any other available and relevant
information about the substance that
is necessary to enable appropriate
risk management measures to be
identified and applied.
All actors in the supply chain or distributors
of a substance on its own or in a
preparation who do not have to supply a
safety data sheet in accordance with Article
29 shall communicate the following
information down the supply chain to the
immediate downstream user or distributor:
DELETED
(a) whether the substance is subject to
authorisation and details of any
authorisation granted or denied
under Title VII in this supply chain;
(b) details of any restriction imposed
under Title VIII;
(c) any other available and relevant
information about the substance that
is necessary to enable appropriate
risk management measures to be
identified and applied.
Justification
The purpose of providing information downs the supply chain is to enable the users of
substance s and preparations to put in place appropriate risk management measures.
Disclosure of all registration numbers will provide confidential information on preparation
composition as well as suppliers. In addition, disclosure of this information provides no
added benefit as this article relates only to non-dangerous substances.
DUCC Amendments to Commission REACH Proposal
25 March 2005
Page 10 of 11
Text of the Commission
Amendment 10
(Please underline the deleted text)
(Underline the added or amended text)
Article 71bis (new)
Article 71bis
Mission of the Agency
The Agency shall be in charge of the
overall management of the REACH
process.
Justification
Entrusting the Agency with the full management of the REACH process ensures an
improved workability of REACH and facilitates a harmonised implementation in an
independent transparent process.
DUCC Amendments to Commission REACH Proposal
25 March 2005
Page 11 of 11
Text of the Commission
Amendment 11
(Please underline the deleted text)
(Underline the added or amended text)
Article 73, paragraph 2, item (j) (new)
Article 73, paragraph 2, item (j)
Tasks
Tasks
establish and maintain a centre of
excellence in risk communication. Provide
centralised and co-ordinated resource
regarding information on safe use of
chemical substances and preparations.
Facilitate knowledge-sharing of best
practice in the area of hazard, risk and safe
use communication.
Justification
The development of an appropriate and consistent communication system based on risk
will provide consumers with the necessary information and advice to enable them to
manage their risk safely and effectively when using a product containing chemicals.
DUCC Amendments to Commission REACH Proposal