Common position (EC) No 17/2006 of 27 June 2006 adopted by the Council, acting in accordance with the procedure referred to in Article 251 of the Treaty establishing the European Community, with a view to adopting 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, amending Directive 1999/45/EC of the European Parliament and of the Council and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC
Date: 2006-06-27
Institutions: Council of the European Union
Subjects: European Chemicals Agency, administrative formalities, chemical product, competitiveness, environmental risk prevention, marketing, scientific report

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I

(Information)

COUNCIL

COMMON POSITION (EC) No 17/2006

adopted by the Council on 27 June 2006

with a view to adopting Regulation (EC) No …/2006 of the European Parliament and of the
Council of… concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals
(REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC of the Euro-
pean Parliament and of the Council and repealing Council Regulation (EEC) No 793/93 and
Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission
Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC

(2006/C 276 E/01)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,

(3)

Having regard to the Treaty establishing the European Com-
munity, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and
Social Committee (1),

(4)

Having regard to the Opinion of
Regions (2),

the Committee of

the

Acting in accordance with the procedure laid down in
Article 251 of the Treaty (3),

Whereas:

(1)

(2)

This Regulation should ensure a high level of protection
of human health and the environment as well as the free
movement of substances, on their own, in preparations
and in articles, while enhancing competitiveness and
innovation.

functioning of

The efficient
for
substances can be achieved only if requirements for
substances do not differ significantly from Member State
to Member State.

the internal market

(1) OJ C 112, 30.4.2004, p. 92 and OJ C 294, 25.11.2005, p. 38.
(2) OJ C 164, 5.7.2005, p. 78.
(3) Opinion of the European Parliament of 17 November 2005 (not yet
published in the Official Journal), Council Common Position of 27
June 2006 and Position of the European Parliament of … (not yet
published in the Official Journal).

A high level of human health and environmental protec-
tion should be ensured in the approximation of legisla-
tion on substances, with the goal of achieving sustain-
able development. That legislation should be applied in a
non-discriminatory manner whether
are
traded on the internal market or internationally.

substances

Pursuant
to the implementation plan adopted on 4
September 2002 at the Johannesburg World Summit on
sustainable development, the European Union is aiming
to achieve that, by 2020, chemicals are produced and
used in ways that lead to the minimisation of significant
adverse effects on human health and the environment.

(5)

This Regulation should apply without prejudice to Com-
munity workplace and environment legislation.

(6)

(7)

This Regulation should contribute to fulfilment of the
Strategic Approach to International Chemical Manage-
ment (SAICM) adopted on 6 February 2006 in Dubai.

To preserve the integrity of the internal market and to
ensure a high level of protection for human health, espe-
cially the health of workers, and the environment, it is
necessary to ensure that manufacturing of substances in
the Community complies with Community law, even if
those substances are exported.

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(8)

(9)

Special account should be taken of the potential impact
of this Regulation on small- and medium-sized enter-
prises (SMEs) and the need to avoid any discrimination
against them.

The assessment of the operation of the four main legal
instruments governing chemicals in the Community, i.e.
Council Directive 67/548/EEC of 27 June 1967 on the
approximation of the laws, regulations and administra-
tive provisions relating to the classification, packaging
substances (1), Council
and labelling of dangerous
Directive 76/769/EEC of 27 July 1976 on the approxi-
mation of the laws, regulations and administrative provi-
sions of the Member States relating to restrictions on the
marketing and use of certain dangerous substances and
preparations (2), Directive 1999/45/EC of the European
Parliament and of
the Council of 31 May 1999
concerning the approximation of the laws, regulations
and administrative provisions of
the Member States
relating to the classification, packaging and labelling of
dangerous preparations (3) and Council Regulation (EEC)
No 793/93 of 23 March 1993 on the evaluation and
control of the risks of existing substances (4), identified a
number of problems in the functioning of Community
legislation on chemicals, resulting in disparities between
the laws, regulations and administrative provisions in
Member States directly affecting the functioning of the
internal market in this field, and the need to do more to
protect public health and the environment in accordance
with the precautionary principle.

(10)

Substances under customs supervision which are in
temporary storage, in free zones or free warehouses with
a view to re-exportation or in transit are not used within
the meaning of this Regulation and should therefore be
excluded from its scope. The carriage of dangerous
substances and of dangerous preparations by rail, road,
inland waterways, sea or air should also be excluded
from its scope as specific legislation already applies to
such carriage.

(11)

To ensure workability and to maintain the incentives for
waste recycling and recovery, wastes should not be
regarded as substances, preparations or articles within
the meaning of this Regulation.

(12) An important objective of the new system to be estab-
lished by this Regulation is to encourage and in certain
cases to ensure that substances of high concern are even-
tually replaced by less dangerous substances or technolo-
gies where suitable economically and technically viable

(1) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission
Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1). Corrected in OJ
L 216, 16.6.2004, p. 3.

(2) OJ L 262, 27.9.1976, p. 201. Directive as last amended by Directive
2005/90/EC of the European Parliament and of the Council (OJ L
33, 4.2.2006, p. 28).

(3) OJ L 200, 30.7.1999, p. 1. Directive as last amended by Commis-

sion Directive 2006/8/EC (OJ L 19, 24.1.2006, p. 12).

(4) OJ L 84, 5.4.1993, p. 1. Regulation as amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council (OJ L
284, 31.10.2003, p. 1).

alternatives are available. This Regulation does not affect
the application of Directives on worker protection and
the environment, especially Directive 2004/37/EC of the
European Parliament and of the Council of 29 April
2004 on the protection of workers from the risks related
to exposure to carcinogens or mutagens at work
(Sixth individual Directive within the meaning of Article
16(1) of Council Directive 89/391/EEC) (5) and Council
Directive 98/24/EC of 7 April 1998 on the protection of
the health and safety of workers from the risks related to
chemical agents at work (fourteenth individual Directive
within the meaning of Article 16(1) of Directive
89/391/EEC) (6) under which employers are required to
eliminate dangerous substances, wherever
technically
possible, or to substitute dangerous substances with less
dangerous substances.

(13)

(14)

(15)

There is a need to ensure effective management of the
technical, scientific and administrative aspects of this
Regulation at Community level. A central entity should
therefore be created to fulfil this role. A feasibility study
on the resource requirements for this central entity
concluded that an independent central entity offered a
number of long-term advantages over other options. A
European Chemicals Agency (hereinafter referred to as
‘the Agency’) should therefore be established.

the management of

Responsibility for
the risks of
substances should lie with the natural or legal persons
import, place on the market or use
that manufacture,
these substances. Information on the implementation of
this Regulation should be easily accessible, in particular
for SMEs.

Therefore,
the registration provisions should require
manufacturers and importers to generate data on the
substances they manufacture or import, to use these
data to assess the risks related to these substances and to
develop and recommend appropriate risk management
measures. To ensure that they actually meet these obliga-
tions, as well as for transparency reasons, registration
should require them to submit a dossier containing all
this information to the Agency. Registered substances
should be allowed to circulate on the internal market.

(16)

The evaluation provisions should provide for follow-up
to registration, by allowing for checks on whether regis-
trations are in compliance with the requirements of this
Regulation and if necessary by allowing for generation
of more information on the properties of substances. If
the Agency in cooperation with the Member States

(5) OJ L 158, 30.4.2004, p. 50. Corrected in OJ L 229, 29.6.2004, p.

23.

(6) OJ L 131, 5.5.1998, p. 11.

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considers that there are grounds for considering that a
substance constitutes a risk to human health or the
environment, the Agency should, after having included
the substance in the Community rolling action plan for
substance evaluation, relying on the competent authori-
ties of Member States, ensure that this substance is eval-
uated.

measures in accordance with the assessment of the risks
of substances and pass on relevant recommendations
along the supply chain. This should include describing,
documenting and notifying in an appropriate and trans-
parent fashion the risks stemming from the production,
use and disposal of each substance.

(22)

(23)

(24)

(25)

(17) Although the information yielded on substances through
evaluation should be used in the first place by manufac-
turers and importers to manage the risks related to their
substances, it may also be used to initiate the authorisa-
tion or restrictions procedures under this Regulation or
risk management procedures under other Community
legislation. Therefore it should be ensured that this infor-
mation is available to the competent authorities and
may be used by them for the purpose of such proce-
dures.

(18)

(19)

(20)

The authorisation provisions should ensure the good
functioning of the internal market while assuring that
the risks from substances of very high concern are prop-
erly controlled. Authorisations for the placing on the
market and use should be granted by the Commission
only if the risks arising from their use are adequately
controlled, where this is possible, or the use can be justi-
fied for socio-economic reasons and no suitable alterna-
tives are available, which are economically and techni-
cally viable.

The restriction provisions should allow the manufac-
turing, placing on the market and use of substances
presenting risks that need to be addressed, to be made
to total or partial bans or other restrictions,
subject
based on an assessment of those risks.

In preparation for this Regulation, the Commission has
launched REACH Implementation Projects (RIPs), invol-
ving relevant experts from stakeholder groups. Some of
those projects aim at developing draft guidelines and
tools which should help the Commission, the Agency,
Member States, manufacturers,
importers and down-
stream users of substances to fulfil, in concrete terms,
their obligations under
this Regulation. This work
should enable the Commission and the Agency to make
in due time,
available appropriate technical guidance,
with regard to the deadlines introduced by this Regu-
lation.

(21)

The responsibility to assess the risks and hazards of
substances should be given,
in the first place, to the
natural or legal persons that manufacture or import
substances, but only when they do so in quantities
exceeding a certain volume, to enable them to carry the
associated burden. Natural or legal persons handling
chemicals should take the necessary risk management

In order to undertake chemical safety assessments of
substances effectively, manufacturers and importers of
these
on
substances
substances, if necessary by performing new tests.

information

should

obtain

transparency,

For purposes of enforcement and evaluation and for
reasons of
the information on these
substances, as well as related information, including on
be
risk management measures,
submitted to authorities.

should normally

Scientific research and development normally takes place
in quantities below 1 tonne per year. There is no need
to exempt
such research and development because
substances in those quantities do not have to be regis-
tered in any case. However, in order to encourage inno-
vation, product and process oriented research and devel-
opment should be exempted from the obligation to
register for a certain time period where a substance is
not yet intended to be placed on the market to an indefi-
nite number of customers because its application in
preparations or articles still requires further research and
development performed by the potential
registrant
himself or in cooperation with a limited number of
known customers.
is appropriate to
In addition,
provide for a similar exemption to downstream users
using the substance for the purposes of product and
process oriented research and development, provided
that the risks to human health and the environment are
adequately controlled in accordance with the require-
ments of legislation for the protection of workers and
the environment.

it

Since producers and importers of articles should be
responsible for their articles, it is appropriate to impose
a registration requirement on substances which are
intended to be released from articles and have not been
registered for that use. In the case of substances of very
in articles above
high concern which are present
tonnage and concentration thresholds, where exposure
to the substance cannot be excluded and where the
substance has not been registered by any person for this
use, the Agency should be notified. The Agency should
that a registration be
also be empowered to request
submitted if
the
release of a substance from the article may present a risk
to human health or the environment and the substance

it has grounds for suspecting that

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is present in those articles in quantities totalling over 1
tonne per producer or importer per year. The Agency
should consider the need for a proposal for a restriction
where it considers that the use of such substances in arti-
cles poses a risk to human health or the environment
that is not adequately controlled.

(30)

of

for

generation

information

Requirements
on
substances should be tiered according to the volumes of
manufacture or importation of a substance, because
these provide an indication of the potential for exposure
of man and the environment to the substances, and
should be described in detail. To reduce the possible
impact on low volume substances, new toxicological and
ecotoxicological information should only be required for
priority substances between 1 and 10 tonnes. For other
substances in that quantity range there should be incen-
tives
to
to encourage manufacturers and importers
provide this information.

(31)

The Member States, the Agency and all interested parties
should take full account of the results of the RIPs, in par-
ticular with regard to the registration of substances
which occur in nature.

(32)

It is necessary to consider the application of Article
2(7)(a) and (b) and Annex XI to substances derived from
mineralogical processes and the review of Annexes IV
and V should fully take this into account.

(33)

(34)

in

out

86/609/EEC

Council Directive

If tests are performed, they should comply with the rele-
vant requirements of protection of laboratory animals,
set
of
24 November 1986 on the approximation of laws, regu-
the Member
lations and administrative provisions of
States regarding the protection of animals used for
experimental and other scientific purposes (1), and, in the
case of ecotoxicological and toxicological
tests, good
laboratory practice, set out in Directive 2004/10/EC of
the European Parliament
the Council of
11 February 2004 on the harmonisation of laws, regula-
tions and administrative provisions relating to the appli-
cation of the principles of good laboratory practice and
the verification of their application for tests on chemical
substances (2).

and of

activity models or

The generation of
information by alternative means
offering equivalence to prescribed tests and test methods
should also be allowed, for example when this informa-
tion comes from valid qualitative or quantitative struc-
ture
related
substances. To this end the Agency, in cooperation with
Member States and interested parties, should develop
appropriate guidance. It should also be possible not to
submit certain information if appropriate justification
can be provided. Based on experience gained through
RIPs, criteria should be developed defining what consti-
tutes such justification.

from structurally

(1) OJ L 358, 18.12.1986, p. 1. Directive as amended by Directive
2003/65/EC of the European Parliament and of the Council (OJ L
230, 16.9.2003, p. 32).
(2) OJ L 50, 20.2.2004, p. 44.

(26)

(27)

The requirements for undertaking chemical safety assess-
should be
ments by manufacturers and importers
defined in detail in a technical annex to allow them to
meet their obligations. To achieve fair burden sharing
with their customers, manufacturers and importers
should in their chemical safety assessment address not
only their own uses and the uses for which they place
their substances on the market, but also all uses which
their customers ask them to address.

The Commission,
in close cooperation with industry,
Member States and other relevant stakeholders, should
develop guidance to fulfil the requirements under this
Regulation related to preparations (in particular with
regard to safety data sheets incorporating exposure
scenarios) including assessment of substances incorpo-
rated into special preparations — such as metals incor-
porated in alloys. In doing so, the Commission should
take full account of the work that will have been carried
out within the framework of
the RIPs and should
include the necessary guidance on this matter in the
overall REACH guidance package. This guidance should
be available before the application of this Regulation.

(28) A chemical safety assessment should not need to be
performed for substances in preparations in certain very
small concentrations which are considered as not giving
rise to concern. Substances in preparations in such low
concentrations should also be exempt from authorisa-
tion. These provisions should apply equally to prepara-
tions that are solid mixtures of substances until a specific
shape is given to such a preparation that transforms it
into an article.

(29)

Joint submission and the sharing of
information on
substances should be provided for in order to increase
the efficiency of the registration system, to reduce costs
and to reduce testing on vertebrate animals. One of a
group of multiple registrants should submit information
on behalf of the others according to rules which ensure
the required information is submitted, while
that all
allowing sharing of the costs burden. A registrant should
be able to submit information directly to the Agency in
certain specified cases.

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In order to help companies, and in particular SMEs, to
comply with the
this Regulation,
requirements of
Member States, in addition to the operational guidance
documents provided by the Agency, should establish
national helpdesks.

(43)

It is necessary to reduce to a minimum the number of
vertebrate animals used for experimental purposes in
accordance with the provisions of Directive 86/609/EEC.
Wherever possible the use of animals should be avoided
by recourse to alternative methods validated by the
European Centre for
the Validation of Alternative
Methods or other international bodies and recognised by
the Commission or the Agency as appropriate.

(35)

(36)

(37)

(38)

Internationally accepted test methods should be recog-
nised and other test methods should be adopted by the
Commission and revised as appropriate, in particular to
refine, reduce or replace animal testing.

For reasons of workability and because of their special
nature, specific registration requirements should be laid
down for intermediates. Polymers should be exempted
from registration and evaluation until those that need to
be registered due to the risks posed to human health or
the environment can be selected in a practicable and
cost-efficient way on the basis of sound technical and
valid scientific criteria.

To avoid overloading authorities and natural or legal
persons with the work arising from the registration of
phase-in substances already on the internal market, that
registration should be spread over an appropriate period
of time, without introducing undue delay. Deadlines for
the registration of these substances should therefore be
set.

(39) Data for substances already notified in accordance with
Directive 67/548/EEC should be eased into the system
and should be upgraded when the next tonnage quantity
threshold is reached.

(40)

(41)

In order to provide a harmonised, simple system, all
registrations should be submitted to the Agency. To
ensure a consistent approach and efficient use of
resources, it should perform a completeness check on all
registrations and take responsibility for any final rejec-
tions of registrations.

a

in

single

European Inventory of

The
Existing Commercial
Chemical Substances (EINECS) included certain complex
substances
entry. UVCB substances
composition,
(substances of unknown or
complex reaction products or biological materials) may
be registered as a single substance under this Regulation,
despite their variable composition, provided that
the
hazardous properties do not differ significantly and
warrant the same classification.

variable

(42)

To ensure that the information gathered through the
registration is kept up-to-date, an obligation on regis-
trants to inform the Agency of certain changes to the
information should be introduced.

(44)

This Regulation should be without prejudice to the full
and complete application of the Community competition
rules.

(45)

(46)

(47)

(48)

(49)

In order to avoid duplication of work, and in particular
to reduce testing involving vertebrate animals, the provi-
sions concerning preparation and submission of registra-
tions and updates should require sharing of information
where this is requested by any registrant. If the informa-
tion concerns vertebrate animals, the registrant should
be obliged to request it.

It is in the public interest to ensure the quickest possible
circulation of test results on human health or environ-
mental hazards of certain substances to those natural or
legal persons which use them, in order to limit any risks
associated with their use. Sharing of information should
occur where this is requested by any registrant, in par-
information involving tests on
ticular in the case of
vertebrate animals, under conditions that ensure a fair
compensation for the company that has undertaken the
tests.

In order to strengthen the competitiveness of Com-
munity industry and to ensure that this Regulation is
it is appropriate to
applied as efficiently as possible,
make provision for the sharing of data between regis-
trants on the basis of fair compensation.

In order to respect
the legitimate property rights of
those generating testing data, the owner of such data
for a period of 10 years, be able to claim
should,
compensation from those registrants who benefit from
that data.

In order to allow a potential registrant to proceed with
his registration, even if he cannot reach agreement with
a previous registrant, the Agency, on request, should
allow use of any summary or robust study summary of
tests already submitted. The registrant who receives
these data should be obliged to pay a contribution to the
costs to the owner of the data.

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(50)

In order to avoid duplication of work, and in particular
to avoid duplication of testing, registrants of phase-in
substances should pre-register as early as possible with a
database managed by the Agency. A system should be
established in order to provide for the establishment of
Substance Information Exchange Fora (SIEF)
to help
registrants to find other registrants. In order to ensure
the smooth functioning of that system they should fulfil
certain obligations. If a member of a SIEF does not fulfil
his obligations, he should be penalised accordingly but
other members should be enabled to continue preparing
their own registration.

(51)

Part of the responsibility of manufacturers or importers
for the management of the risks of substances is the
communication of information on these substances to
other professionals such as downstream users or distri-
butors. This important responsibility should also apply
throughout the supply chain to enable all actors to meet
their responsibility in relation to management of risks
arising from the use of substances.

(52) As the existing safety data sheet is already being used as
a communication tool within the supply chain of
substances and preparations, it is appropriate to develop
it further and make it an integral part of the system
established by this Regulation.

(53)

In order to have a chain of responsibilities, downstream
users should be responsible for assessing the risks arising
those uses are not
from their uses of substances if
received from their
covered by a safety data sheet
suppliers, unless the downstream user concerned takes
more protective measures than those recommended by
his supplier or unless his supplier was not required to
assess those risks or provide him with information on
those risks. For the same reason, downstream users
should manage the risks arising from their uses of
is appropriate that any
substances.
it
producer or
containing a
an article
importer of
substance of very high concern should provide sufficient
information to allow safe use of such an article.

In addition,

(54)

The requirements for undertaking chemical safety assess-
ments by downstream users should also be prescribed in
detail to allow them to meet their obligations. These
requirements should only apply above a total quantity of
1 tonne of substance or preparation.
In any case,
however, the downstream users should consider the use

and identify and apply appropriate risk management
measures. Downstream users should report certain basic
information on use to the Agency.

(55)

For enforcement and evaluation purposes, downstream
users of substances should be required to report to the
Agency certain basic information if their use is outside
the conditions of the exposure scenario detailed in the
safety data sheet communicated by their original manu-
facturer or importer and to keep such reported informa-
tion up-to-date.

(56)

For reasons of workability and proportionality,
is
appropriate to exempt downstream users using low
quantities of a substance from such reporting.

it

(57)

Communication up and down the supply chain should
be facilitated. The Commission should develop a system
categorising brief general descriptions of uses taking into
account the outcomes of the RIPs.

(58)

(59)

(60)

It is also necessary to ensure that generation of informa-
tion is tailored to real information needs. To this end
evaluation should require the Agency to decide on the
programmes of testing proposed by manufacturers and
importers.
the
Agency should give priority to certain substances, for
instance those which may be of very high concern.

In cooperation with Member States,

it is necessary to instil confidence in the
In addition,
general quality of registrations and to ensure that the
public at large as well as all stakeholders in the chemi-
cals industry have confidence that natural or
legal
persons are meeting the obligations placed upon them.
Accordingly, it is appropriate to provide for recording
which information has been reviewed by an assessor
possessing appropriate experience, and for a percentage
of registrations to be checked for compliance by the
Agency.

The Agency should also be empowered to require
further information from manufacturers,
importers or
downstream users on substances suspected of posing a
risk to human health or the environment, including by
reason of their presence on the internal market in high
volumes, on the basis of evaluations performed. Based
on the criteria for prioritising substances developed by
the Agency in cooperation with the Member States a
Community rolling action plan for substance evaluation

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should be established, relying on Member State compe-
tent authorities to evaluate substances included therein.
If a risk equivalent to the level of concern arising from
the use of substances subject to authorisation arises from
the use of isolated intermediates on site, the competent
authorities of the Member States should also be allowed
to require further information, when justified.

allow thresholds where appropriate to be used in the
context of authorising the use of carcinogenic and muta-
genic substances.

(61)

Collective agreement within the Agency's Member State
Committee on its draft decisions should provide the
basis for an efficient system that respects the principle of
subsidiarity, while maintaining the internal market.
If
one or more Member States or the Agency do not agree
to a draft decision,
it should be adopted subject to a
centralised procedure. If the Member State Committee
fails to reach unanimous agreement, the Commission
should adopt a decision in accordance with a Committee
procedure.

(62)

Evaluation may lead to the conclusion that action should
be taken under the restriction or authorisation proce-
dures or that risk management action should be consid-
ered in the framework of other appropriate legislation.
Information on the progress of evaluation proceedings
should therefore be made public.

(65)

(66)

(67)

(63)

the

and

sub-populations,

To ensure a sufficiently high level of protection for
including having regard to relevant
human health,
human population groups and possibly to certain
vulnerable
environment,
substances of very high concern should, in accordance
with the precautionary principle, be subject to careful
attention. Authorisation should be granted where natural
or legal persons applying for an authorisation demon-
strate to the granting authority that the risks to human
health and the environment arising from the use of the
substance are adequately controlled. Otherwise, uses
may still be authorised if it can be shown that the socio-
economic benefits
the substance
outweigh the risks connected with its use and there are
no suitable alternative substances or technologies that
are economically and technically viable. Taking into
account the good functioning of the internal market it is
appropriate that the Commission should be the granting
authority.

from the use of

the

aim of

eventual

replacement of
To support
substances of very high concern by suitable alternative
substances or technologies, all applicants for authorisa-
tion should provide an analysis of alternatives consid-
ering their risks and the technical and economic feasi-
bility of substitution. Furthermore, authorisations should
be subject to time-limited review whose periods would
be determined on a case-by-case basis and normally be
subject to conditions, including monitoring.

Experience at international level shows that substances
with characteristics rendering them persistent, liable to
bioaccumulate and toxic, or very persistent and very
liable to bioaccumulate, present a very high concern,
while criteria have been developed allowing the identifi-
cation of such substances. For certain other substances
concerns are sufficiently high to address them in the
same way on a case-by-case basis.

In view of workability and practicality considerations,
both as regards natural or legal persons, who have to
prepare application files and take appropriate risk
management measures, and as regards the authorities,
who have to process authorisation applications, only a
limited number of substances should be subjected to the
authorisation procedure at the same time and realistic
deadlines should be set for applications, while allowing
certain uses to be exempted. Substances identified as
meeting the criteria for authorisation should be included
in a candidate list for eventual inclusion in the authorisa-
tion procedure. Within this list, substances on the Agen-
cy's work programme should be clearly identified.

(68)

The Agency should provide advice on the prioritisation
of substances to be made subject to the authorisation
procedure, to ensure that decisions reflect the needs of
society as well as scientific knowledge and develop-
ments.

(64) Methodologies to establish thresholds for carcinogenic
and mutagenic substances may be developed taking into
account the outcomes of RIPs. The relevant Annex may
be amended on the basis of these methodologies to

(69) A total ban on a substance would mean that none of its
uses could be authorised. It would therefore be pointless
to allow the submission of applications for authorisation.
In such cases the substance should be removed from the
list of
can be
submitted and added to the list of restricted substances.

for which applications

substances

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(70)

(71)

functioning of

The proper
interaction between the provisions on
authorisation and restriction should be ensured in order
to preserve the efficient
the internal
market and the protection of human health, safety and
the environment. Restrictions
that exist when the
substance in question is added to the list of substances
for which applications
authorisation can be
for
submitted, should be maintained for that substance. The
from
consider whether
Agency
substances in articles is adequately controlled and, if it is
not, prepare a dossier in relation to introduction of
further restrictions for substances for which the use
requires authorisation.

should

risk

the

In order to provide a harmonised approach to the
authorisation of the uses of particular substances, the
Agency should issue opinions on the risks arising from
those uses
analysis
submitted to it by third parties.

socio-economic

and on any

(72)

To allow effective monitoring and enforcement of the
authorisation requirement, downstream users benefiting
from an authorisation granted to their supplier should
inform the Agency of their use of the substance.

(73)

(74)

should

restructured

In order to accelerate the current system the restriction
procedure
and
be
Directive 76/769/EEC, which has been substantially
amended and adapted several times, should be replaced.
In the interests of clarity and as a starting point for this
new accelerated restriction procedure the acquis of the
harmonised rules under the Annex to that Directive
should be recast and taken over. This recast follows the
rules set out within the Interinstitutional Agreement of
28 November 2001 on a more structured use of the
recasting
technique
concerning
recasting techniques.

texts (1)

legal

for

In relation to Annex XVII Member States should be
allowed to maintain for a transitional period more strin-
gent restrictions, provided that these restrictions have
been notified according to the Treaty. This should
concern substances on their own, substances in prepara-
tions and substances in articles, the manufacturing, the
placing on the market and the use of which is restricted.
The Commission should compile and publish an inven-
tory of these restrictions. This would provide an oppor-
tunity for
the Commission to review the measures
concerned with a view to possible harmonisation.

(75)

It should be the responsibility of
the manufacturer,
importer and downstream user to identify the appro-
priate risk management measures needed to ensure a
high level of protection for human health and the envir-

(1) OJ C 77, 28.3.2002, p. 1.

onment from the manufacturing, placing on the market
or use of a substance on its own, in a preparation or in
an article. However, where this is considered to be insuf-
ficient and where Community legislation is justified,
appropriate restrictions should be laid down.

In order to protect human health and the environment,
restrictions on the manufacture, placing on the market
or use of a substance on its own, in a preparation or in
an article may include any condition for, or prohibition
the manufacture, placing on the market or use.
of,
Therefore it is necessary to list such restrictions and any
amendments thereto.

In order to prepare a restrictions proposal and in order
for such legislation to operate effectively, there should
be good cooperation, coordination and information
between the Member States, the Agency, other bodies of
the Commission and the interested
the Community,
parties.

In order to give Member States the opportunity to
submit proposals to address a specific risk for human
health and the environment,
they should prepare a
dossier in conformity with detailed requirements. The
dossier should set out the justification for Community-
wide action.

In order to provide a harmonised approach to restric-
tions, the Agency should fulfil a role as coordinator of
this procedure, for example by appointing the relevant
rapporteurs and verifying conformity with the require-
ments of
the relevant Annexes. The Agency should
maintain a list of substances for which a restriction
dossier is being prepared.

(76)

(77)

(78)

(79)

(80)

In order to give the Commission the opportunity to
address a specific risk for human health and the environ-
ment that needs to be addressed Community wide,
it
should be able to entrust the Agency with the prepara-
tion of a restriction dossier.

(81)

For reasons of transparency, the Agency should publish
the relevant dossier including the suggested restrictions
while requesting comments.

(82)

In order to finalise the procedure in due time,
the
Agency should submit its opinions on the suggested
action and its impact on the basis of a draft opinion
prepared by a rapporteur.

(83)

In order to speed up the procedure for restrictions, the
Commission should prepare its draft amendment within
a specific time limit of receiving the Agency's opinions.

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(84)

(85)

(86)

The Agency should be central to ensuring that chemicals
legislation and the decision-making processes and scien-
tific basis underlying it have credibility with all stake-
holders and the public. The Agency should also play a
pivotal role in coordinating communication around this
Regulation and in its implementation. The confidence in
the Agency of the Community institutions, the Member
States, the general public and interested parties is there-
it is vital to ensure its
fore essential. For this reason,
independence, high scientific, technical and regulatory
capacities, as well as transparency and efficiency.

The structure of the Agency should be suitable for the
tasks that it should fulfil. Experience with similar Com-
munity agencies provides some guidance in this respect
but the structure should be adapted to meet the specific
needs of this Regulation.

In the interests of efficiency, the staff of the Agency
Secretariat should perform essentially technical-adminis-
trative and scientific tasks without calling on the scien-
tific and technical resources of the Member States. The
Executive Director should ensure the efficient execution
of the Agency's tasks in an independent manner. To
ensure that the Agency fulfils its role, the composition
of the Management Board should be designed to repre-
sent each Member State,
the Commission and other
interested parties appointed by the Commission in order
to ensure the involvement of stakeholders, and to secure
the highest standard of competence and a broad range
of relevant expertise in chemicals safety or the regulation
of chemicals, whilst ensuring that there is relevant exper-
tise in the field of general financial and legal matters.

(87)

The Agency should have the means to perform all the
tasks required to carry out its role.

(88) A Commission Regulation should specify the structure
and amounts of fees,
including specifying the circum-
stances under which a proportion of the fees will be
transferred to the relevant Member State competent
authority.

(89)

The Management Board of the Agency should have the
necessary powers to establish the budget, check its
implementation, draw up internal rules, adopt financial
regulations and appoint the Executive Director.

attached to the Commission in issuing scientific opinions
in its field of competence.

(91)

Through a Member State Committee, the Agency should
aim to reach agreement amongst Member States authori-
ties on specific issues which require a harmonised
approach.

(92)

(93)

It is necessary to ensure close cooperation between the
Agency and the competent authorities working within
the Member States so that the scientific opinions of the
Committee for Risk Assessment and the Committee for
Socio-economic Analysis are based on the broadest
possible scientific and technical expertise appropriate
which is available within the Community. To the same
end, these Committees should be able to rely on addi-
tional particular expertise.

In the light of the increased responsibility of natural or
legal persons for ensuring safe use of chemicals, enforce-
ment needs to be strengthened. The Agency should
therefore provide a Forum for Member States
to
exchange information on and to coordinate their activ-
ities related to the enforcement of chemicals legislation.
The currently informal cooperation between Member
States in this respect would benefit from a more formal
framework.

(94) A Board of Appeal should be set up within the Agency
to guarantee processing of appeals for any natural or
legal person affected by decisions taken by the Agency.

(95)

the

The Agency should be financed partly by fees paid by
natural or legal persons and partly by the general budget
of
European Communities. The Community
budgetary procedure should remain applicable as far as
any subsidies chargeable to the general budget of the
the
European Communities are concerned. Moreover,
auditing of accounts should be undertaken by the Court
of Auditors
in accordance with Article 91 of
Commission Regulation (EC, Euratom) No 2343/2002 of
23 December 2002 on the framework Financial Regu-
lation for the bodies referred to in Article 185 of
Council Regulation (EC, Euratom) No 1605/2002 on the
Financial Regulation applicable to the general budget of
the European Communities (1).

(90)

Through a Committee for Risk Assessment and a
Committee for Socio-economic Analysis,
the Agency
should take over the role of the Scientific Committees

(96) Where the Commission and Agency consider it appro-
priate, it should be possible for representatives of third
countries to participate in the work of the Agency.

(1) OJ L 357, 31.12.2002, p. 72.

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Official Journal of the European Union

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(97)

The Agency should contribute,
through cooperation
with organisations having interests in the harmonisation
of international regulations, to the role of the Com-
munity and the Member States in such harmonisation
activities. To promote broad international consensus the
Agency should take account of existing and emerging
international standards in the regulation of chemicals
such as the Globally Harmonised System (GHS) of classi-
fication and labelling of chemicals.

(98)

The Agency should provide the infrastructure needed for
natural or legal persons to meet their obligations under
the data-sharing provisions.

(99)

It is important to avoid confusion between the mission
of the Agency and the respective missions of the Euro-
pean Medicines Agency (EMEA) established by Regu-
lation (EC) No 726/2004 of the European Parliament
and of the Council of 31 March 2004 laying down Com-
munity procedures for the authorisation and supervision
of medicinal products for human and veterinary use and
establishing a European Medicines Agency (1), the Euro-
pean Food Safety Authority (EFSA) established by Regu-
lation (EC) No 178/2002 of the European Parliament
and of the Council of 28 January 2002 laying down the
general principles and requirements of food law, estab-
lishing the European Food Safety Authority and laying
down procedures in matters of food safety (2) and the
Advisory Committee on Safety, Hygiene and Health
Protection at Work set up by the Council Decision of
22 July 2003 (3). Consequently, the Agency should estab-
lish rules of procedure where cooperation with the EFSA
or the Advisory Committee on Safety, Hygiene and
Health Protection at Work is necessary. This Regulation
should otherwise be without prejudice to the compe-
tence conferred on the EMEA, the EFSA and the Advi-
sory Committee on Safety, Hygiene and Health Protec-
tion at Work by Community legislation.

(100)

the internal
In order to achieve the functioning of
market for substances on their own or in preparations,
while at the same time ensuring a high level of protec-
tion for human health and the environment,
rules
should be established for a classification and labelling
inventory.

(101) The classification and labelling for any substance either
to registration or covered by Article 1 of

subject

(1) OJ L 136, 30.4.2004, p. 1.
(2) OJ L 31, 1.2.2002, p. 1. Regulation as last amended by Commission

Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3).

(3) OJ C 218, 13.9.2003, p. 1.

Directive 67/548/EEC and placed on the market should
therefore be notified to the Agency to be included in the
inventory.

classification

(102) To ensure a harmonised protection for the general
public, and,
in particular, for persons who come into
contact with certain substances, and the proper func-
tioning of other Community legislation relying on the
classification and labelling, an inventory should record
the
with
in
Directive 67/548/EEC and Directive 1999/45/EC agreed
by manufacturers and importers of the same substance,
if possible, as well as decisions taken at Community level
to harmonise the classification and labelling of some
substances. This should take full account of the work
and experience accumulated in connection with the
activities under Directive 67/548/EEC, including the clas-
sification and labelling of specific substances or groups
of substances listed in Annex I of Directive 67/548/EEC.

accordance

(103) Resources

should be focused on substances of

the
highest concern. A substance should therefore be added
to Annex I of Directive 67/548/EEC if
it meets the
criteria for classification as carcinogenic, mutagenic or
toxic for reproduction categories 1, 2 or 3, as a respira-
tory sensitiser, or in respect of other effects on a case-
by-case basis. Provision should be made to enable
competent authorities
to the
Agency. The Agency should give its opinion on the
proposal while interested parties should have an oppor-
tunity to comment. The Commission should take a deci-
sion subsequently.

to submit proposals

(104) Regular reports by the Member States and the Agency
on the operation of this Regulation will be an indispen-
sable means of monitoring the implementation of this
Regulation as well as trends in this field. Conclusions
drawn from findings in the reports will be useful and
practical tools for reviewing this Regulation and, where
necessary, for formulating proposals for amendments.

(105) EU-citizens should have access to information about
chemicals to which they may be exposed, in order to
allow them to make informed decisions about their use
of chemicals. A transparent means of achieving this is to
grant them free and easy access to basic data held in the
Agency's database, including brief profiles of hazardous
properties,
labelling requirements and relevant Com-
munity legislation including authorised uses and risk
management measures. The Agency and Member States
should allow access to information in accordance with
Directive 2003/4/EC of the European Parliament and
of the Council of 28 January 2003 on public access to

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C 276E/11

and of

environmental information and repealing Coucil Direc-
tive 90/313/EEC (1), Regulation (EC) No 1049/2001 of
the European Parliament
the Council of
30 May 2001 regarding public access to European
and Commission documents (2)
Parliament, Council
and with the UNECE Convention on Access to Informa-
tion, Public Participation in Decision-Making and Access
to Justice in Environmental Matters, to which the Euro-
pean Community is a party.

(111)

It is essential that chemicals be regulated in an effective
and timely manner during the transition to full applic-
ability of the provisions of this Regulation and, in par-
ticular, during the start-up period of the Agency. Provi-
sion should therefore be made for the Commission to
provide the necessary support towards the setting up of
the Agency,
including the conclusion of contracts and
the appointment of an Executive Director ad interim until
the Agency's Management Board can appoint an Execu-
tive Director itself.

(106) Apart from their participation in the implementation of
Community legislation, Member State competent autho-
rities should, because of their closeness to stakeholders
in the Member States, play a role in the exchange of
information on risks of substances and on the obliga-
tions of natural or legal persons under chemicals legisla-
tion. At the same time, close cooperation between the
Agency, the Commission and the competent authorities
of the Member States is necessary to ensure the coher-
ence
communication
process.

and efficiency of

the global

(107)

In order for the system established by this Regulation to
operate effectively, there should be good cooperation,
coordination and exchange of information between the
the Agency and the Commission
Member States,
regarding enforcement.

(108)

In order to ensure compliance with this Regulation,
Member States should put in place effective monitoring
and control measures. The necessary inspections should
be planned, carried out and their results should be
reported.

(109)

In order to ensure transparency, impartiality and consis-
tency in the level of enforcement activities by Member
States, it is necessary for Member States to set up an
appropriate framework for penalties with a view to
imposing effective, proportionate and dissuasive penal-
ties for non-compliance, as non-compliance can result in
damage to human health and the environment.

(112) To take full advantage of the work performed under
Regulation (EEC) No 793/93 as well
as under
Directive 76/769/EEC and to avoid such work being
lost, the Commission should be empowered during the
start-up period to initiate restrictions based on that work
without
following the full restrictions procedure laid
down in this Regulation. All those elements should be
used, as soon as this Regulation enters into force, to
support risk reduction measures.

(113)

It is appropriate for the provisions of this Regulation to
enter into force in a staggered way to smooth the transi-
tion to the new system. Moreover, a gradual entry into
force of the provisions should allow all parties involved,
authorities, natural or legal persons as well as stake-
holders, to focus resources in the preparation for new
duties at the right times.

Directive

91/155/EEC (4),

(114) This Regulation replaces Directive 76/769/EEC, Commis-
sion
Commission
Directive
Commission
Directive
Commission
Directive 2000/21/EC (7), Regulation (EEC) No 793/93
and Commission Regulation (EC) No 1488/94 (8). These
Directives and Regulations should therefore be repealed.

93/67/EEC (5),
93/105/EC (6),

(4) Commission Directive 91/155/EEC of 5 March 1991 defining and
laying down the detailed arrangements for the system of specific
information relating to dangerous preparations in implementation
of Article 10 of Directive 88/379/EEC (OJ L 76, 22.3.1991, p. 35).
Directive as last amended by Directive 2001/58/EC (OJ L 212,
7.8.2001, p. 24).

(5) Commission Directive 93/67/EEC of 20 July 1993 laying down the
principles for assessment of risks to man and the environment of
substances
Council
Directive 67/548/EEC (OJ L 227, 8.9.1993, p. 9).

accordance

notified

with

in

(110) The measures necessary for the implementation of this
Regulation and certain amendments to it should be
adopted
Council
accordance
Decision 1999/468/EC of 28 June 1999 laying down
the procedures for the exercise of implementing powers
conferred on the Commission (3).

with

in

(1) OJ L 41, 14.2.2003, p. 26.
(2) OJ L 145, 31.5.2001, p. 43.
(3) OJ L 184, 17.7.1999, p. 23.

(6) Commission Directive 93/105/EC of 25 November 1993 laying
down Annex VII D, containing information required for the tech-
nical dossier referred to in Article 12 of the seventh amendment of
Council Directive 67/548/EEC (OJ L 294, 30.11.1993, p. 21).

(7) Commission Directive 2000/21/EC of 25 April 2000 concerning
the list of Community legislation referred to in the fifth indent of
Article 13(1) of Council Directive 67/548/EEC (OJ L 103,
28.4.2000, p. 70).

(8) Commission Regulation (EC) No 1488/94 of 28 June 1994 laying
down the principles for the assessment of risks to man and the
environment of existing substances in accordance with Council
Regulation (EEC) No 793/93 (OJ L 161, 29.6.1994, p. 3).

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(115) For the sake of consistency, Directive 1999/45/EC which
already addresses matters covered by this Regulation
should be amended.

(116) Since the objectives of this Regulation, namely laying
down rules for substances and establishing a European
Chemicals Agency, cannot be sufficiently achieved by
the Member States and can therefore be better achieved
at Community level,
the Community may adopt
measures,
in accordance with the principle of subsi-
diarity as set out in Article 5 of the Treaty. In accord-
ance with the principle of proportionality, as set out in

that Article, this Regulation does not go beyond what is
necessary in order to achieve those objectives.

(117) The Regulation observes the fundamental rights and
principles which are acknowledged in particular in the
Charter of
the European
Union (1). In particular, it seeks to ensure full compliance
with the principles of environmental protection and
sustainable development guaranteed by Article 37 of
that Charter,

Fundamental Rights of

HAVE ADOPTED THIS REGULATION:

(1) OJ C 364, 18.12.2000, p. 1.

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TABLE OF CONTENTS

TITLE I

GENERAL ISSUES

Chapter 1

Aim, scope and application

Chapter 2

Definitions and general provision

TITLE II

REGISTRATION OF SUBSTANCES

Chapter 1

General obligation to register and information requirements

Chapter 2

Substances regarded as being registered

Chapter 3

Obligation to register and information requirements for certain types of isolated intermedi-
ates

Chapter 4

Common provisions for all registrations

Chapter 5

Transitional provisions applicable to phase-in substances and notified substances

TITLE III

DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING

Chapter 1

Objectives and general rules

Chapter 2

Rules for non-phase-in substances and registrants of phase-in substances who have not pre-
registered

Chapter 3

Rules for phase-in-substances

TITLE IV

INFORMATION IN THE SUPPLY CHAIN

TITLE V

DOWNSTREAM USERS

TITLE VI

EVALUATION

Chapter 1

Dossier evaluation

Chapter 2

Substance evaluation

Chapter 3

Evaluation of intermediates

Chapter 4

Common provisions

TITLE VII

AUTHORISATION

Chapter 1

Authorisation requirement

Chapter 2

Granting of authorisations

Chapter 3

Authorisations in the supply chain

TITLE VIII

RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF
CERTAIN DANGEROUS SUBSTANCES AND PREPARATIONS

Chapter 1

General issues

Chapter 2

Restrictions process

TITLE IX

FEES AND CHARGES

TITLE X

AGENCY

TITLE XI

CLASSIFICATION AND LABELLING INVENTORY

TITLE XII

INFORMATION

TITLE XIII

COMPETENT AUTHORITIES

TITLE XIV

ENFORCEMENT

TITLE XV

TRANSITIONAL AND FINAL PROVISIONS

ANNEX I

GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING
CHEMICAL SAFETY REPORTS

ANNEX II

GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS

ANNEX III

ANNEX IV

ANNEX V

CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10
TONNES

EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH
ARTICLE 2(7)(a)

EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH
ARTICLE 2(7)(b)

Page

15

15

16

19

19

24

24

26

28

28

28

28

29

31

33

35

35

36

38

38

40

40

43

45

46

46

46

48

48

58

59

61

61

61

66

78

87

88

92

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ANNEX VI

INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10

ANNEX VII

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFAC-
TURED OR IMPORTED IN QUANTITIES OF 1 TONNE OR MORE

ANNEX VIII ADDITIONAL STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES

MANUFACTURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE

ANNEX IX

ANNEX X

ANNEX XI

ADDITIONAL STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES
MANUFACTURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE

ADDITIONAL STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES
MANUFACTURED OR IMPORTED IN QUANTITIES OF 1000 TONNES OR MORE

GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET
OUT IN ANNEXES VII TO X

ANNEX XII

GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES
AND PREPARE CHEMICAL SAFETY REPORTS

ANNEX XIII

CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE
AND TOXIC SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULA-
TIVE SUBSTANCES

ANNEX XIV

LIST OF SUBSTANCES SUBJECT TO AUTHORISATION

ANNEX XV

DOSSIERS

ANNEX XVI

SOCIO-ECONOMIC ANALYSIS

ANNEX XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE

OF CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES

Page

93

97

101

105

110

113

116

118

119

120

122

123

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TITLE I

GENERAL ISSUES

CHAPTER 1

Aim, scope and application

2. Waste, as defined in Directive 2006/12/EC of the Euro-
pean Parliament and of
the Council of 5 April 2006 on
waste (2) is not a substance, preparation or article within the
meaning of Article 3 of this Regulation.

Article 1

Aim and scope

1.
The purpose of this Regulation is to ensure a high level
of protection of human health and the environment as well as
the free circulation of substances on the internal market while
enhancing competitiveness and innovation.

2.
This Regulation lays down provisions on substances and
preparations within the meaning of Article 3. These provisions
shall apply to the manufacture, placing on the market or use of
such substances on their own, in preparations or in articles and
to the placing on the market of preparations.

3.
This Regulation is based on the principle that it is for
manufacturers, importers and downstream users to ensure that
they manufacture, place on the market or use such substances
that do not adversely affect human health or the environment.
Its provisions are underpinned by the precautionary principle.

Article 2

Application

1.

This Regulation shall not apply to:

(a) radioactive

substances within the

scope of Council
Directive 96/29/Euratom of 13 May 1996 laying down
basic safety standards for the protection of the health of
workers and the general public against the dangers arising
from ionising radiation (1);

(b) substances, on their own, in a preparation or in an article,
which are subject to customs supervision, provided that
they do not undergo any treatment or processing, and
which are in temporary storage, or in a free zone or free
warehouse with a view to re-exportation, or in transit;

(c) non-isolated intermediates;

(d) the

carriage of dangerous

substances and dangerous
substances in dangerous preparations by rail, road, inland
waterway, sea or air.

(1) OJ L 159, 29.6.1996, p. 1.

3. Member States may allow for exemptions from this Regu-
lation in specific cases for certain substances, on their own, in
a preparation or in an article, where necessary in the interests
of defence.

legislation,

This Regulation shall apply without prejudice to Com-
4.
munity workplace and environmental
including
Council Directive 89/391/EEC of 12 June 1989 on the intro-
duction of measures to encourage improvements in the safety
and health of workers at work (3), Council Directive 96/61/EC
of 24 September 1996 concerning integrated pollution preven-
tion and control (4); Directive 98/24/EC, Directive 2000/60/EC
of the European Parliament and of the Council of 23 October
2000 establishing a framework for Community action in the
field of water policy (5) and Directive 2004/37/EC.

The provisions of Titles II, V, VI and VII shall not apply

5.
to the extent that a substance is used:

of

(EC)

scope

Regulation

(a) in medicinal products for human or veterinary use within
the
726/2004,
Directive 2001/82/EC of the European Parliament and of
the Council of 6 November 2001 on the Community code
relating
and
Directive 2001/83/EC of the European Parliament and of
the Council of 6 November 2001 on the Community code
relating to medicinal products for human use (7);

veterinary medicinal

products (6)

No

to

(b) in food or feedingstuffs in accordance with Regulation (EC)

No 178/2002 including use:

(i) as a food additive in foodstuffs within the scope of
Council Directive 89/107/EEC of 21 December 1988
on the approximation of
the Member
States concerning food additives authorised for use in
foodstuffs intended for human consumption (8);

the laws of

(2) OJ L 114, 27.4.2006, p. 9.
(3) OJ L 183, 29.6.1989, p. 1. Directive as amended by Regulation (EC)

No 1882/2003.

(4) OJ L 257, 10.10.1996, p. 26. Directive as last amended by Regu-
lation (EC) No 166/2006 of the European Parliament and of the
Council (OJ L 33, 4.2.2006, p. 1).

(5) OJ L 327, 22.12.2000, p. 1. Directive as amended by Decision No
2455/2001/EC of the European Parliament and of the Council (OJ L
331, 15.12.2001, p. 1).

(6) OJ L 311, 28.11.2001, p. 1. Directive as last amended by Directive
2004/28/EC of the European Parliament and of the Council (OJ L
136, 30.4.2004, p. 58).

(7) OJ L 311, 28.11.2001, p. 67. Directive as last amended by Directive
2004/27/EC of the European Parliament and of the Council (OJ L
136, 30.4.2004, p. 34).

(8) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation

(EC) No 1882/2003.

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(ii) as a flavouring in foodstuffs within the scope of
Council Directive 88/388/EEC of 22 June 1988 on the
approximation of
the Member States
the laws of
relating to flavourings for use in foodstuffs and to
source materials for their production (1) and Commis-
sion Decision 1999/217/EC of 23 February 1999
adopting a register of flavouring substances used in or
on foodstuffs drawn up in application of Regulation
(EC) No 2232/96 of the European Parliament and of
the Council (2);

(iii) as an additive in feedingstuffs within the scope of
Regulation (EC) No 1831/2003 of the European Parlia-
ment and of the Council of 22 September 2003 on
additives for use in animal nutrition (3);

(iv) in animal nutrition within the scope of Council Direc-
tive 82/471/EEC of 30 June 1982 concerning certain
products used in animal nutrition (4).

The provisions of Title IV shall not apply to the following

6.
preparations in the finished state, intended for the final user:

(a) medicinal products for human or veterinary use, within the
scope of Regulation (EC) No 726/2004 and Directive
2001/82/EC and as defined in Directive 2001/83/EC;

(b) cosmetic products

defined in Council Directive
76/768/EEC of 27 July 1976 on the approximation of the
laws of the Member States relating to cosmetic products (5);

as

(c) medical devices which are invasive or used in direct
physical contact with the human body in so far as Com-
munity measures lay down provisions for the classification
and labelling of dangerous substances and preparations
which ensure the same level of information provision and
protection as Directive 1999/45/EC;

7.

The following shall be exempted from Titles II, V and VI:

(a) substances included in Annex IV, as sufficient information
is known about these substances that they are considered
to cause minimum risk because of their intrinsic properties;

(b) substances covered by Annex V, as registration is deemed
inappropriate or unnecessary for these substances and their
exemption from these Titles does not prejudice the objec-
tives of this Regulation;

(c) substances on their own or in preparations, registered in
accordance with Title II, exported from the Community by
an actor in the supply chain and re-imported into the Com-
munity by the same or another actor in the same supply
chain who shows that:

(i) the substance being re-imported is the same as the

exported substance;

(ii) he has been provided with the information in accord-
ance with Articles 31 or 32 relating to the exported
substance.

(d) substances, on their own,

in preparations or in articles,
which have been registered in accordance with Title II and
which are recovered in the Community if:

(i) the substance that results from the recovery process is
the same as the substance that has been registered in
accordance with Title II; and

(ii) the information required by Articles 31 or 32 relating
to the substance that has been registered in accordance
with Title II is available to the establishment under-
taking the recovery.

On-site isolated intermediates and transported isolated

8.
intermediates shall be exempted from:

(a) Chapter 1 of Title II, with the exception of Articles 8 and

9; and

(d) food or feedingstuffs in accordance with Regulation (EC)

(b) Title VII.

No 178/2002 including use:

(i) as a food additive in foodstuffs within the scope of

Directive 89/107/EEC;

(ii) as a flavouring in foodstuffs within the scope of Direc-

tive 88/388/EEC and Decision 1999/217/EC;

(iii) as an additive in feedingstuffs within the scope of

Regulation (EC) No 1831/2003;

(iv) in animal nutrition within the scope of Directive

82/471/EEC.

(1) OJ L 184, 15.7.1988, p. 61. Directive as last amended by Regu-

lation (EC) No 1882/2003.

(2) OJ L 84, 27.3.1999, p. 1. Decision as last amended by Decision

2006/252/EC (OJ L 91, 29.3.2006, p. 48.

(3) OJ L 268, 18.10.2003, p. 29. Regulation as amended by Commis-

sion Regulation (EC) No 378/2005 (OJ L 59, 5.3.2005, p. 8).

(4) OJ L 213, 21.7.1982, p. 8. Directive as last amended by Commis-

sion Directive 2004/116/EC (OJ L 379, 24.12.2004, p. 81).

(5) OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commis-

sion Directive 2006/65/EC (OJ L 198, 20.7.2006, p. 11).

The provisions of Titles II and VI shall not apply to poly-

9.
mers.

CHAPTER 2

Definitions and general provision

Article 3

Definitions

For the purposes of this Regulation:

1) Substance: means a chemical element and its compounds
in the natural state or obtained by any manufacturing
process,
including any additive necessary to preserve its
stability and any impurity deriving from the process used,
but excluding any solvent which may be separated without
affecting the stability of the substance or changing its
composition;

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2) Preparation: means a mixture or solution composed of two

or more substances;

to be transformed into another substance (hereinafter
referred to as ‘synthesis’):

3) Article: means an object which during production is given
a special shape, surface or design which determines its
function to a greater degree than does its chemical compo-
sition;

4) Polymer: means a substance consisting of molecules char-
acterised by the sequence of one or more types of
monomer units. Such molecules must be distributed over a
range of molecular weights wherein differences in the
molecular weight are primarily attributable to differences
in the number of monomer units. A polymer comprises
the following:

(a) a simple weight majority of molecules containing at
least three monomer units which are covalently bound
to at least one other monomer unit or other reactant;

(b) less than a simple weight majority of molecules of the

same molecular weight.

In the context of this definition a ‘monomer unit’ means
the reacted form of a monomer substance in a polymer;

5) Monomer: means a substance which is capable of forming
covalent bonds with a sequence of additional like or unlike
molecules under the conditions of the relevant polymer-
forming reaction used for the particular process;

6) Registrant: means the manufacturer or the importer of a
substance or the producer or importer of an article submit-
ting a registration for a substance;

7) Manufacturing: means production or

extraction of

substances in the natural state;

8) Manufacturer: means any natural or legal person estab-
lished within the Community who manufactures
a
substance within the Community;

9) Import: means the physical introduction into the customs

territory of the Community;

10) Importer: means any natural or legal person established
within the Community who is responsible for import;

11) Placing on the market: means supplying or making avail-
able, whether in return for payment or free of charge, to a
third party. Import shall be deemed to be placing on the
market;

12) Downstream user: means any natural or legal person estab-
lished within the Community, other than the manufacturer
or the importer, who uses a substance, either on its own
or in a preparation,
in the course of his industrial or
professional activities. A distributor or a consumer is not a
downstream user. A re-importer exempted pursuant to
Article 2(7)(c) shall be regarded as a downstream user;

13) Distributor: means any natural or legal person established
within the Community,
including a retailer, who only
stores and places on the market a substance, on its own or
in a preparation, for third parties;

14) Intermediate: means a substance that is manufactured for
and consumed in or used for chemical processing in order

(a) non-isolated intermediate: means an intermediate that
during synthesis is not intentionally removed (except
for sampling) from the equipment in which the synth-
esis takes place. Such equipment includes the reaction
its ancillary equipment, and any equipment
vessel,
through which the substance(s) pass(es) during a
continuous flow or batch process as well as the pipe-
work for transfer from one vessel to another for the
purpose of the next reaction step, but it excludes tanks
or other vessels in which the substance(s) are stored
after the manufacture;

(b) on-site isolated intermediate: means an intermediate
not meeting the criteria of a non-isolated intermediate
and where the manufacture of the intermediate and
the synthesis of (an)other substance(s) from that inter-
mediate take place on the same site, operated by one
or more legal entities;

(c) transported isolated intermediate: means an inter-
mediate not meeting the criteria of a non-isolated
intermediate and transported between or supplied to
other sites;

15) Site: means a single location, in which, if there is more
than one manufacturer of (a) substance(s), certain infra-
structure and facilities are shared;

16) Actors in the supply chain: means all manufacturers and/
or importers and/or downstream users in a supply chain;

17) Agency: means the European Chemicals Agency as estab-

lished by this Regulation;

18) Competent authority: means the authority or authorities or
bodies established by the Member States to carry out the
obligations arising from this Regulation;

19) Phase-in substance: means a substance which meets at

least one of the following criteria:

(a) it

is listed in the European Inventory of Existing

Commercial Chemical Substances (EINECS);

(b) it was manufactured in the Community, or in the
countries acceding to the European Union on 1
January 1995 or on 1 May 2004, but not placed on
the market by the manufacturer or importer, at least
once in the 15 years before the entry into force of this
Regulation, provided the manufacturer or importer has
documentary evidence of this;

(c) it was placed on the market in the Community, or in
the countries acceding to the European Union on 1
January 1995 or on 1 May 2004, before entry into
force of
this Regulation by the manufacturer or
importer and was considered as having been notified
in accordance with the first indent of Article 8(1) of
Directive 67/548/EEC but does not meet the definition
of a polymer as set out in this Regulation, provided
the manufacturer or
importer has documentary
evidence of this;

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20) Notified substance: means a substance for which a notifica-
tion has been submitted and which could be placed on the
market in accordance with Directive 67/548/EEC;

33) Recipient of an article: means an industrial or professional
user being supplied with an article but does not include
consumers;

21) Product and process orientated research and development:
means any scientific development related to product devel-
opment or the further development of a substance, on its
own, in preparations or in articles in the course of which
pilot plant or production trials are used to develop the
production process and/or to test the fields of application
of the substance;

22) Scientific research and development: means any scientific
experimentation, analysis or chemical research carried out
under controlled conditions in a volume less than 1 tonne
per year;

23) Use: means any processing,

formulation, consumption,
storage, keeping, treatment, filling into containers, transfer
from one container to another, mixing, production of an
article or any other utilisation;

24) Registrant's own use: means an industrial or professional

use by the registrant;

25) Identified use: means a use of a substance on its own or in
a preparation, or a use of a preparation, that is intended
by an actor in the supply chain, including his own use, or
that is made known to him in writing by an immediate
downstream user;

26) Full study report: means a complete and comprehensive
description of the activity performed to generate the infor-
the complete scientific paper as
mation. This covers
published in the literature describing the study performed
or the full report prepared by the test house describing the
study performed;

27) Robust study summary: means a detailed summary of the
objectives, methods, results and conclusions of a full study
report providing sufficient information to make an inde-
pendent assessment of the study minimising the need to
consult the full study report;

28) Study summary: means a summary of

the objectives,
methods, results and conclusions of a full study report
providing sufficient information to make an assessment of
the relevance of the study;

29) Per year: means per calendar year unless stated otherwise;

30) Restriction: means any condition for or prohibition of the

manufacture, use or placing on the market;

31) Supplier of a substance or a preparation: means any manu-
facturer, importer, downstream user or distributor placing
on the market a substance, on its own or in a preparation,
or a preparation;

32) Recipient of a substance or a preparation: means a down-
stream user or a distributor being supplied with a
substance or a preparation;

34) SME: means small and medium-sized enterprises as defined
in the Commission Recommendation of 6 May 2003
concerning the definition of micro, small and medium-
sized enterprises (1);

35) Exposure scenario: means

the set of conditions

that
describe how the substance is manufactured or used
during its life-cycle and how the manufacturer or importer
controls, or recommends downstream users to control,
exposures of humans and the environment. These expo-
sure scenarios may cover one specific process or use or
several processes or uses as appropriate;

36) Use and exposure category: means an exposure scenario

covering a wide range of processes or uses;

37) Substances which occur

in nature: means a naturally
occurring substance as such, unprocessed or processed
only by manual, mechanical or gravitational means, by
dissolution in water, by flotation, by extraction with water,
by steam distillation or by heating solely to remove water,
or which is extracted from air by any means;

38) Not chemically modified substance: means a substance
whose chemical structure remains unchanged, even if it
has undergone a chemical process or treatment, or a
physical mineralogical
instance to
remove impurities;

transformation,

for

39) Alloy: means a metallic material, homogenous on a macro-
two or more elements so
they cannot be readily separated by

scopic scale, consisting of
combined that
mechanical means.

Article 4

General provision

Any manufacturer,
importer, or where relevant downstream
user, may, whilst retaining full responsibility for complying
with his obligations under this Regulation, appoint a third
party representative for all proceedings under Article 11,
Article 19, Title III and Article 52 involving discussions with
other manufacturers, importers, or where relevant downstream
users. In these cases, the identity of a manufacturer or importer
or downstream user who has appointed a representative shall
not normally be disclosed by the Agency to other manufac-
turers, importers, or, where relevant, downstream users.

(1) OJ L 124, 20.5.2003, p. 36.

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TITLE II

REGISTRATION OF SUBSTANCES

CHAPTER 1

(b) the substance is intended to be released under normal or

reasonably foreseeable conditions of use.

General obligation to register and information requirements

Article 5

No data, no market

Subject to Articles 6, 7, 21 and 23, substances on their own, in
preparations or in articles shall not be manufactured in the
Community or placed on the market unless they have been
registered in accordance with the relevant provisions of this
Title where this is required.

A submission for registration shall be accompanied by the fee
required in accordance with Title IX.

2.
Any producer or importer of articles shall notify the
Agency, in accordance with paragraph 4 of this Article, if a
substance meets the criteria in Article 56 and is identified in
accordance with Article 58(1), if both the following conditions
are met:

(a) the substance is present in those articles in quantities total-

ling over 1 tonne per producer or importer per year;

Article 6

(b) the substance is present in those articles above a concentra-

tion of 0,1 % weight by weight (w/w).

General obligation to register substances on their own or
in preparations

1.
Save where this Regulation provides otherwise, any
manufacturer or importer of a substance, either on its own or
in one or more preparation(s), in quantities of 1 tonne or more
per year shall submit a registration to the Agency.

2.
For monomers that are used as on-site isolated intermedi-
ates or transported isolated intermediates, Articles 17 and 18
shall not apply.

3.
Any manufacturer or importer of a polymer shall submit
a registration to the Agency for the monomer substance(s) or
any other substance(s), that have not already been registered by
an actor up the supply chain, if both the following conditions
are met:

(a) the polymer consists of 2 % weight by weight (w/w) or
more of such monomer substance(s) or other substance(s)
in the form of monomeric units and chemically bound
substance(s);

(b) the total quantity of such monomer substance(s) or other

substance(s) makes up 1 tonne or more per year.

A submission for registration shall be accompanied by

4.
the fee required in accordance with Title IX.

3.
Paragraph 2 shall not apply where the producer or
importer can exclude exposure to humans or the environment
during normal or reasonably foreseeable conditions of use
including disposal. In such cases, the producer or importer
shall supply appropriate instructions to the recipient of the
article in accordance with Article 32(4).

4.
The
following:

information to be notified shall

include

the

(a) the identity and contact details of the producer or importer
as specified in section 1 of Annex VI, with the exception of
their own use sites;

(b) the registration number(s) referred to in Article 20(1),

if

available;

(c) the identity of the substance as specified in sections 2.1 to

2.3.4 of Annex VI;

(d) the classification of the substance(s) as specified in sections

4.1 and 4.2 of Annex VI;

(e) a brief description of the use(s) of the substance(s) in the
article as specified in section 3.5 of Annex VI and of the
uses of the article(s);

Article 7

(f) the tonnage range of the substance(s), such as 1-10 tonnes,

10-100 tonnes and so on.

Registration and notification of substances in articles

1.
Any producer or importer of articles shall submit a regis-
tration to the Agency for any substance contained in those arti-
cles, if both the following conditions are met:

The Agency may take decisions requiring producers or
in accordance
if all the

5.
importers of articles to submit a registration,
with this Title, for any substance in those articles,
following conditions are met:

(a) the substance is present in those articles in quantities total-

(a) the substance is present in those articles in quantities total-

ling over 1 tonne per producer or importer per year;

ling over 1 tonne per producer or importer per year;

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(b) the Agency has grounds for suspecting that:

(i) the substance is released from the articles, and

with listed customers and in a quantity which is limited to the
purpose of product and process orientated research and devel-
opment.

(ii) the release of the substance from the articles presents a

risk to human health or the environment;

(c) the substance is not subject to paragraph 1.

A submission for registration shall be accompanied by the fee
required in accordance with Title IX.

Paragraphs 1 to 5 shall not apply to substances that have

6.
already been registered for that use.

2.
For the purpose of paragraph 1, the manufacturer or
importer or producer of articles shall notify the Agency of the
following information:

(a) the identity of the manufacturer or importer or producer of

articles as specified in section 1 of Annex VI;

(b) the identity of the substance, as specified in section 2 of

Annex VI;

7.
From … (*) paragraphs 2, 3 and 4 of this Article shall
apply 6 months after a substance is identified in accordance
with Article 58(1).

(c) the classification of the substance as specified in section 4

of Annex VI, if any;

8.
Any measures for the implementation of paragraphs 1 to
7 shall be adopted in accordance with the procedure referred
to in Article 132(3).

Article 8

Only representative of a non-Community manufacturer

1.
A natural or legal person established outside the Com-
munity who manufactures a substance on its own, in prepara-
tions or in articles, formulates a preparation or produces an
article that is imported into the Community may by mutual
agreement appoint a natural or legal person established in the
Community to fulfil, as his only representative, the obligations
on importers under this Title.

2.
The representative shall also comply with all other obliga-
tions of importers under this Regulation. To this end, he shall
have a sufficient background in the practical handling of
substances and the information related to them and, without
prejudice to Article 35, shall keep available and up-to-date
information on quantities imported and customers sold to, as
well as information on the supply of the latest update of the
safety data sheet referred to in Article 31.

3.
If a representative is appointed in accordance with para-
graphs 1 and 2, the non-Community manufacturer shall inform
the importer(s) within the same supply chain of the appoint-
ment. These importers shall be regarded as downstream users
for the purposes of this Regulation.

Article 9

Exemption from the general obligation to register for
product and process orientated research and development
(PPORD)

1.
Articles 5, 6, 7, 17, 18 and 21 shall not apply for a
period of five years to a substance manufactured in the Com-
munity or imported for the purposes of product and process
orientated research and development by a manufacturer or
importer or producer of articles, by himself or in cooperation

(*) 42 months after entry into force of this Regulation.

(d) the estimated quantity as specified in section 3.1 of Annex

VI;

(e) the list of customers referred to in paragraph 1, including

their names and addresses.

The notification shall be accompanied by the fee required in
accordance with Title IX.

The period set out in paragraph 1 shall begin at receipt of the
notification at the Agency.

3.
The Agency shall check the completeness of the informa-
tion supplied by the notifier and Article 20(2) shall apply
adapted as necessary. The Agency shall assign a number to the
notification and a notification date, which shall be the date of
receipt of the notification at the Agency, and shall forthwith
communicate that number and date to the manufacturer or
importer concerned. The Agency shall also communicate this
information to the competent authority of the Member State(s)
concerned.

4.
The Agency may decide to impose conditions with the
aim of ensuring that the substance or the preparation or article
in which the substance is incorporated will be handled only by
staff of listed customers as referred to in paragraph 2(e)
in
reasonably controlled conditions,
in accordance with the
requirements of legislation for the protection of workers and
the environment, and will not be made available to the general
public at any time either on its own or in a preparation or
article and that remaining quantities will be re-collected for
disposal after the exemption period.

In such cases, the Agency may ask the notifier to provide addi-
tional necessary information.

In the absence of any indication to the contrary, the
5.
manufacturer or importer of the substance may manufacture or
import the substance not earlier than two weeks after the noti-
fication.

6.
The manufacturer or importer or producer of articles
shall comply with any conditions imposed by the Agency in
accordance with paragraph 4.

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7.
The Agency may decide to extend the five-year exemp-
tion period by a further maximum of five years or, in the case
of substances to be used exclusively in the development of
medicinal products for human or veterinary use, for a further
maximum of ten years, upon request if the manufacturer or
importer or producer of articles can demonstrate that such an
extension is
research and development
programme.

justified by the

8.
The Agency shall forthwith communicate any draft deci-
sions to the competent authorities of each Member State in
which the manufacture, import or product and process orien-
tated research takes place.

When taking decisions as provided for in paragraphs 4 and 7,
the Agency shall take into account any comments made by
such competent authorities.

9.
the
The Agency and the competent authorities of
Member States concerned shall always keep confidential the
information submitted in accordance with paragraphs 1 to 8.

10.
An appeal may be brought, in accordance with Articles
90, 91 and 92, against Agency decisions under paragraphs 4
and 7 of this Article.

Article 10

Information to be submitted for general registration
purposes

(viii) an indication as

information
to which of
submitted under (iii), (iv), (vi), (vii) or subparagraph
(b) has been reviewed by an assessor chosen by the
manufacturer or importer and having appropriate
experience;

the

(ix) proposals for testing where listed in Annexes IX and

X;

(x) for substances in quantities of 1 to 10 tonnes, expo-
sure information as specified in section 6 of Annex
VI;

the manufacturer or

(xi) a request as to which of the information in Article
considers
118(2)
in
should not be made available on the Internet
accordance with Article 76(2)(d), including a justifica-
tion as to why publication could be harmful for his
or any other concerned party's commercial interests.

importer

Except in cases covered under Article 25(3), Article 27(6)
or Article 30(3), the registrant shall be in legitimate posses-
sion of or have permission to refer to the full study report
summarised under (vi) and (vii) for the purpose of registra-
tion;

(b) a chemical safety report when required under Article 14, in
the format specified in Annex I. The relevant sections of
this report may include, if the registrant considers appro-
priate, the relevant use and exposure categories.

A registration required by Article 6 or by Article 7(1) or (5)
shall include all the following information:

Article 11

(a) a technical dossier including:

Joint submission of data by multiple registrants

(i) the identity of the manufacturer(s) or importer(s) as

specified in section 1 of Annex VI;

(ii) the identity of the substance as specified in section 2

of Annex VI;

(iii) information on the manufacture and use(s) of the
substance as specified in section 3 of Annex VI; this
information shall represent all the registrant's identi-
fied use(s). This information may include, if the regis-
trant deems appropriate, the relevant use and expo-
sure categories;

(iv) the classification and labelling of the substance as

specified in section 4 of Annex VI;

(v) guidance on safe use of the substance as specified in

Section 5 of Annex VI;

(vi) study summaries of the information derived from the

application of Annexes VII to XI;

(vii) robust study summaries of the information derived
from the application of Annexes VII to XI, if required
under Annex I;

1. When a substance is intended to be manufactured in the
Community by one or more manufacturers and/or imported by
one or more importers, the following shall apply.

Subject to paragraph 3, the information specified in Article
10(a)(iv), (vi), (vii) and (ix), and any relevant indication under
Article 10(a)(viii) shall first be submitted by the one manufac-
turer or importer acting with the agreement of
the other
assenting manufacturer(s) or importer(s) (hereinafter referred to
as ‘the lead registrant’).

Each registrant shall subsequently submit separately the infor-
mation specified in Article 10(a)(i), (ii), (iii) and (x), and any
relevant indication under Article 10(a)(viii).

The registrants may decide themselves whether to submit the
information specified in Article 10(a)(v) and (b) and any rele-
vant indication under Article 10 (a)(viii) separately or whether
one manufacturer or importer is to submit this information on
behalf of the others.

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Each manufacturer or importer need only comply with
2.
paragraph 1 for items of
information specified in Article
10(a)(iv), (vi), (vii) and (ix) that are required for the purposes of
registration within his tonnage band in accordance with Article
12.

A manufacturer or importer may submit the information

3.
referred to in Article 10(a)(iv), (vi), (vii) or (ix) separately if:

(a) it would be disproportionately costly for him to submit this

information jointly; or

(b) submitting the information jointly would lead to disclosure
of
information which he considers to be commercially
sensitive and is likely to cause him substantial commercial
detriment; or

(c) he disagrees with the lead registrant on the selection of this

information.

If points (a), (b) or (c) apply, the manufacturer or importer shall
submit, along with the dossier, an explanation as to why the
costs would be disproportionate, why disclosure of information
was likely to lead to substantial commercial detriment or the
nature of the disagreement, as the case may be.

A submission for registration shall be accompanied by

4.
the fee required in accordance with Title IX.

Article 12

Information to be submitted depending on tonnage

1.
The technical dossier referred to in Article 10(a) shall
include under points (vi) and (vii) of that provision all physico-
chemical, toxicological and ecotoxicological information that is
relevant and available to the registrant and as a minimum the
following:

(a) the information specified in Annex VII for non-phase-in
substances, and for phase-in substances meeting one or
both of the criteria specified in Annex III, manufactured or
imported in quantities of 1 tonne or more per year per
manufacturer or importer;

(b) the information on physicochemical properties specified in
Annex VII, section 7 for phase-in substances manufactured
or imported in quantities of 1 tonne or more per year per
manufacturer or importer which do not meet either of the
criteria specified in Annex III;

fied in Annex IX for substances manufactured or imported
in quantities of 100 tonnes or more per year per manufac-
turer or importer;

(e) the information specified in Annexes VII and VIII and
testing proposals for the provision of the information speci-
fied in Annexes IX and X for substances manufactured or
imported in quantities of 1 000 tonnes or more per year
per manufacturer or importer.

2.
As soon as the quantity of a substance per manufacturer
or importer that has already been registered reaches the next
tonnage threshold, the manufacturer or importer shall inform
the Agency immediately of
information he
would require under paragraph 1. Article 26 (3) and (4) shall
apply adapted as necessary.

the additional

Article 13

General requirements for generation of information on
intrinsic properties of substances

from information from structurally

1.
Information on intrinsic properties of substances may be
generated by means other than tests, in particular through the
use of qualitative or quantitative structure-activity relationship
models or
related
substances (grouping or read-across), provided that the condi-
tions set out in Annex XI are met. Testing in accordance with
Annex VIII, section 8.6 and 8.7, Annex IX and Annex X may
be omitted where justified by information on exposure and
implemented risk management measures
specified in
Annex XI, section 3.

as

2. Where tests on substances are required to generate infor-
they shall be
mation on intrinsic properties of substances,
conducted in accordance with the test methods laid down in a
Commission Regulation adopted in accordance with the proce-
dure referred to in Article 132(3), which shall be revised as
appropriate in particular to refine, reduce or replace animal
testing, or in accordance with other international test methods
recognised by the Commission or the Agency as being appro-
priate.

Information on intrinsic properties of substances may be gener-
ated in accordance with other test methods provided that the
conditions set out in Annex XI are met.

(c) the information specified in Annexes VII and VIII

for
substances manufactured or
imported in quantities of
10 tonnes or more per year per manufacturer or importer;

(d) the information specified in Annexes VII and VIII and
testing proposals for the provision of the information speci-

Ecotoxicological and toxicological tests and analyses shall
3.
be carried out
in compliance with the principles of good
laboratory practice provided for in Directive 2004/10/EC or
other international standards recognised as being equivalent by
the Commission or the Agency and with the provisions of
Directive 86/609/EEC, if applicable.

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4.
If a substance has already been registered, a new regis-
trant shall be entitled to refer to the study summaries or robust
study summaries,
for the same substance submitted earlier,
provided that he can show that the substance that he is now
registering is
the one previously registered,
including the degree of purity and the nature of impurities, and
that the previous registrant(s) have given permission to refer to
the full study reports for the purpose of registration.

the same as

A new registrant shall not refer to such studies in order to
provide the information required in section 2 of Annex VI.

Article 14

Chemical safety report and duty to apply and recommend
risk reduction measures

1. Without prejudice to Article 4 of Directive 98/24/EC, a
chemical safety assessment shall be performed and a chemical
safety report completed for all substances subject to registration
in accordance with this Chapter if the registrant manufactures
or imports such a substance in quantities of 10 tonnes or more
per year.

The chemical safety report shall document the chemical safety
assessment which shall be conducted in accordance with para-
graphs 2 to 7 and with Annex I for either each substance on
its own or in a preparation or a group of substances.

2.
A chemical safety assessment in accordance with para-
graph 1 need not be performed for a substance which is
present in a preparation if the concentration of the substance
the
in the preparation is less than the lowest of any of
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 XI of this Regulation;

(f) 0,1 % weight by weight (w/w), if the substance meets the

criteria in Annex XIII of this Regulation.

A chemical safety assessment of a substance shall include

3.
the following steps:

(a) human health hazard assessment;

(b) physicochemical hazard assessment;

(c) environmental hazard assessment;

(d) persistent, bioaccumulative and toxic (PBT) and very persis-

tent and very bioaccumulative (vPvB) assessment.

4.
If, as a result of carrying out steps (a) to (d) of paragraph
3, the manufacturer or importer concludes that the substance
meets the criteria for classification as dangerous in accordance
with Directive 67/548/EEC or is assessed to be a PBT or vPvB,
the chemical safety assessment shall include the following addi-
tional steps:

(a) exposure assessment including the generation of exposure
scenario(s) (or the identification of relevant use and expo-
sure categories if appropriate) and exposure estimation;

(b) risk characterisation.

The exposure scenarios (where appropriate the use and expo-
sure categories), exposure assessment and risk characterisation
shall address all
the manufacturer or
importer.

identified uses of

The chemical safety report need not include consideration

5.
of the risks to human health from the following end uses:

(a) in food contact materials within the scope of Regulation
(EC) No 1935/2004 of the European Parliament and of the
Council of 27 October 2004 on materials and articles
intended to come into contact with food and repealing
Directives 80/590/EEC and 89/109/EEC (1);

(b) in

cosmetic
Directive 76/768/EEC.

products

within

the

scope

of

Any manufacturer or importer shall

6.
identify and apply
the appropriate measures to adequately control the risks identi-
fied in the chemical safety assessment, and where suitable,
recommend them in the safety data sheets which he supplies in
accordance with Article 31.

7.
Any manufacturer or importer required to conduct a
chemical safety assessment shall keep his chemical safety report
available and up to date.

(1) OJ L 338, 13.11.2004, p. 4.

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CHAPTER 2

Substances regarded as being registered

1896/2000 (7), until the date of the decision referred to in the
second subparagraph of Article 16(2) of Directive 98/8/EC,
shall be regarded as being registered and the registration as
completed for manufacture or import for the use in a biocidal
product and therefore as fulfilling the requirements of Chapters
1 and 5 of this Title.

Article 15

Article 16

Substances in plant protection and biocidal products

1.
Active substances and co-formulants manufactured or
imported for use in plant protection products only and
included either in Annex I to Directive 91/414/EEC (1) or in
Regulation (EEC) No 3600/92 (2), Regulation (EC) No
703/2001 (3), Regulation (EC) No 1490/2002 (4), Decision
2003/565/EC (5) and for any substance for which a Commis-
sion Decision on the completeness of the dossier has been
taken pursuant to Article 6 of Directive 91/414/EEC shall be
regarded as being registered and the registration as completed
for manufacture or import for the use as a plant protection
product and therefore as fulfilling the requirements of Chapters
1 and 5 of this Title.

2.
Active substances manufactured or imported for use in
biocidal products only and included either in Annexes I, IA or
IB to Directive 98/8/EC of the European Parliament and of the
Council of 16 February 1998 concerning the placing of
biocidal products on the market (6) or in Commission Regu-
lation (EC) No 2032/2003 of 4 November 2003 on the second
phase of
referred to in
Article 16(2) of Directive 98/8/EC of the European Parliament
and of the Council concerning the placing of biocidal products
(EC) No
on

the 10-year work programme

amending Regulation

the market,

and

Duties of the Commission, the Agency and registrants of
substances regarded as being registered

The Commission or the relevant Community body shall
1.
make information equivalent to that required by Article 10
available to the Agency for substances regarded as registered
according to Article 15. The Agency shall include this informa-
tion or a reference thereto in its databases and notify the
competent authorities thereof by … (*).

Articles 21, 22 and 25 to 28 shall not apply to uses of

2.
substances regarded as registered according to Article 15.

CHAPTER 3

Obligation to register and information requirements for
certain types of isolated intermediates

Article 17

Registration of on-site isolated intermediates

(1) Council Directive 91/414/EEC of 15 July 1991 concerning the
placing of plant protection products on the market (OJ L 230,
19.8.1991, p. 1). Directive as last amended by Commission Directive
2006/75/EC (OJ L 248, 12.9.2006, p. 3).

(2) Commission Regulation (EEC) No 3600/92 of 11 December 1992
laying down the detailed rules for the implementation of the first
stage of the programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC concerning the placing of plant
protection products on the market (OJ L 366, 15.12.1992, p. 10).
Regulation as last amended by Regulation (EC) No 2266/2000 (OJ L
259, 13.10.2000, p. 27).

(3) Commission Regulation (EC) No 703/2001 of 6 April 2001 laying
down the active substances of plant protection products to be
assessed in the second stage of the work programme referred to in
Article 8(2) of Council Directive 91/414/EEC and revising the list of
Member States designated as rapporteurs for those substances (OJ L
98, 7.4.2001, p. 6).

(4) Commission Regulation (EC) No 1490/2002 of 14 August 2002
laying down further detailed rules for the implementation of the
third stage of the programme of work referred to in Article 8(2) of
Council Directive 91/414/EEC and amending Regulation (EC) No
451/2000 (OJ L 224, 21.8.2002, p. 23). Regulation as last amended
by Regulation (EC) No 1744/2004 (OJ L 311, 8.10.2004, p. 23).
(5) Commission Decision 2003/565/EC of 25 July 2003 extending the
time period provided for in Article 8(2) of Council Directive
91/414/EEC (OJ L 192, 31.7.2003, p. 40).

(6) OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commis-

sion Directive 2006/50/EC (OJ L 142, 30.5.2006, p. 6).

Any manufacturer of an on-site isolated intermediate in
1.
quantities of 1 tonne or more per year shall submit a registra-
tion to the Agency for the on-site isolated intermediate.

A registration for an on-site isolated intermediate shall
2.
include all the following information, to the extent that the
manufacturer
it without any additional
testing:

is able to submit

(a) the identity of the manufacturer as specified in section 1 of

Annex VI;

(b) the identity of the intermediate as specified in sections 2.1

to 2.3.4 of Annex VI;

(c) the classification of the intermediate as specified in section

4 of Annex VI;

(7) OJ L 307, 24.11.2003, p. 1. Regulation as amended by Regulation

(EC) No 1048/2005 (OJ L 178, 9.7.2005, p. 1).
(*) 18 months after entry into force of this Regulation.

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(d) any available existing information on physicochemical,
human health or environmental properties of the inter-
mediate. Where a full study report is available, a study
summary shall be submitted;

(e) a brief general description of the use, as specified in section

3.5 of Annex VI;

(f) details of the risk management measures applied.

Except in cases covered under Article 25(3), Article 27(6) or
Article 30(3), the registrant shall be in legitimate possession of
or have permission to refer to the full study report summarised
under (d) for the purpose of registration.

The registration shall be accompanied by the fee required in
accordance with Title IX.

3.
Paragraph 2 shall apply only to on-site isolated intermedi-
ates if the manufacturer confirms that the substance is only
manufactured and used under strictly controlled conditions in
that it is rigorously contained by technical means during its
whole lifecycle. Control and procedural technologies shall be
used to minimise emission and any resulting exposure.

these conditions are not

If
include the information specified in Article 10.

fulfilled,

the registration shall

or have permission to refer to the full study report summarised
under (d) for the purpose of registration.

The registration shall be accompanied by the fee required in
accordance with Title IX.

A registration for a transported isolated intermediate in
3.
quantities of more than 1 000 tonnes per year per manufac-
turer or importer shall
include the information specified in
Annex VII in addition to the information required under para-
graph 2.

For the generation of this information, Article 13 shall apply.

4.
Paragraphs 2 and 3 shall apply only to transported
isolated intermediates if the manufacturer or importer confirms
himself or states that he has received confirmation from the
user that the synthesis of (an)other substance(s) from that inter-
mediate takes place on other sites under the following strictly
controlled conditions:

(a) the substance is rigorously contained by technical means
during its whole lifecycle including manufacture, purifica-
tion, cleaning and maintenance of equipment, sampling,
analysis,
loading and unloading of equipment or vessels,
waste disposal or purification and storage;

Article 18

(b) procedural and control

technologies shall be used that

minimise emission and any resulting exposure;

Registration of transported isolated intermediates

(c) only properly trained and authorised personnel handle the

substance;

1.
Any manufacturer or importer of a transported isolated
intermediate in quantities of 1 tonne or more per year shall
submit a registration to the Agency for the transported isolated
intermediate.

A registration for a transported isolated intermediate shall

2.
include all the following information:

(a) the identity of the manufacturer or importer as specified in

section 1 of Annex VI;

(b) the identity of the intermediate as specified in sections 2.1

to 2.3.4 of Annex VI;

(c) the classification of the intermediate as specified in section

4 of Annex VI;

(d) any available existing information on physicochemical,
human health or environmental properties of the inter-
mediate. Where a full study report is available, a study
summary shall be submitted;

(d) in the case of cleaning and maintenance works, special
procedures such as purging and washing are applied before
the system is opened and entered;

(e) in cases of accident and where waste is generated, proce-
dural and/or control technologies are used to minimise
emissions and the resulting exposure during purification or
cleaning and maintenance procedures;

(f) substance-handling procedures are well documented and

strictly supervised by the site operator.

the conditions listed in the first subparagraph are not
If
fulfilled, the registration shall include the information specified
in Article 10.

Article 19

(e) a brief general description of the use, as specified in section

3.5 of Annex VI;

Joint submission of data on isolated intermediates by
multiple registrants

(f) information on risk management measures applied and
recommended to the user in accordance with paragraph 4.

Except in cases covered under Article 25(3), Article 27(6) or
Article 30(3), the registrant shall be in legitimate possession of

1. When an on-site isolated intermediate or transported
isolated intermediate is intended to be manufactured in the
Community by one or more manufacturers and/or imported by
one or more importers, the following shall apply.

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Subject to paragraph 2 of this Article, the information specified
in Article 17(2)(c) and (d) and Article 18(2)(c) and (d) shall first
be submitted by one manufacturer or importer acting with the
agreement of the other assenting manufacturer(s) or importer(s)
(hereinafter referred to as ‘the lead registrant’).

The Agency shall undertake the completeness check within
three weeks of the submission date, or within three months of
the relevant deadline of Article 23, as regards registrations of
phase-in substances submitted in the course of the two-month
period immediately preceding that deadline.

Each registrant shall subsequently submit separately the infor-
(e) and (f) and
mation specified in Article 17(2)(a),
Article 18(2)(a),(b), (e) and (f).

(b),

A manufacturer or importer may submit the information
2.
referred to in Article 17(2)(c) or (d) and Article 18(2)(c) or (d)
separately if:

(a) it would be disproportionately costly for him to submit this

jointly; or

(b) submitting the information jointly would lead to disclosure
of
information which he considers to be commercially
sensitive and is likely to cause him substantial commercial
detriment; or

(c) he disagrees with the lead registrant on the selection of this

information.

If points (a), (b) or (c) apply, the manufacturer or importer shall
submit, along with the dossier, an explanation as to why the
costs would be disproportionate, why disclosure of information
was likely to lead to substantial commercial detriment, or the
nature of the disagreement, as the case may be.

A submission for registration shall be accompanied by

3.
the fee required in accordance with Title IX.

inform the
If a registration is incomplete, the Agency shall
registrant, before expiry of
the three-week or three-month
period referred to in the second subparagraph, as to what
further information is required in order for the registration to
be complete, while setting a reasonable deadline for this. The
registrant shall complete his registration and submit it to the
Agency within the deadline set. The Agency shall confirm the
submission date of the further information to the registrant.
The Agency shall perform a further completeness check,
considering the further information submitted.

The Agency shall reject the registration if the registrant fails to
complete his registration within the deadline set. The registra-
tion fee shall not be reimbursed in such cases.

3.
Once the registration is complete, the Agency shall assign
a registration number to the substance concerned and a regis-
tration date, which shall be the same as the submission date.
The Agency shall without delay communicate the registration
number and registration date to the registrant concerned. The
registration number shall be used for all subsequent cor-
respondence regarding registration.

4.
The Agency shall notify the competent authority of the
relevant Member State within 30 days of the submission date,
that the following information is available in the Agency data-
base:

CHAPTER 4

(a) the registration dossier together with the submission or

registration number;

Common provisions for all registrations

(b) the submission or registration date;

Article 20

Duties of the Agency

1.
The Agency shall assign a submission number to each
to be used for all correspondence
registration, which is
regarding the registration until the registration is deemed to be
complete, and a submission date, which shall be the date of
receipt of the registration at the Agency.

2.
The Agency shall undertake a completeness check of each
registration in order to ascertain that all the elements required
under Articles 10 and 12 or under Articles 17 or 18, as well as
the registration fee referred to in Article 6(4), Article 7(1) and
(5), Article 17(2) or Article 18(2), have been provided. The
completeness check shall not include an assessment of the
quality or the adequacy of any data or justifications submitted.

(c) the result of the completeness check; and

(d) any request for further information and deadline set in
accordance with the third subparagraph of paragraph 2.

The relevant Member State shall be the Member State within
which the manufacture takes place or the importer is estab-
lished.

If the manufacturer has production sites in more than one
Member State, the relevant Member State shall be the one in
which the head office of the manufacturer is established. The
other Member States where the production sites are established
shall also be notified.

The Agency shall forthwith notify the competent authority of
the relevant Member State(s) when any further information
submitted by the registrant is available on the Agency database.

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5.
An appeal may be brought, in accordance with Articles
90, 91 and 92, against Agency decisions under paragraph 2 of
this Article.

the Agency in respect of the registration of the registrant acting
on behalf of the others and his own registration.

6. Where additional information for a particular substance is
submitted to the Agency by a new registrant, the Agency shall
notify the existing registrants that this information is available
on the database for the purposes of Article 22.

Article 22

Further duties of registrants

Article 21

1.
Following registration, a registrant shall be responsible on
his own initiative for updating his registration without undue
delay with relevant new information and submitting it to the
Agency in the following cases:

Manufacturing and import of substances

(a) any change in his status, such as being a manufacturer or
an importer, or in his identity, such as his name or address;

1.
A registrant may start or continue the manufacture or
import of a substance or production or import of an article, if
there is no indication to the contrary from the Agency in
accordance with Article 20(2) within the three weeks after the
submission date, without prejudice to Article 27(8).

In the case of registrations of phase-in substances, a registrant
may continue the manufacture or import of the substance or
production or import of an article, if there is no indication to
the contrary from the Agency in accordance with Article 20(2)
within the three weeks after
if
submitted within the two-month period before the relevant
deadline of Article 23, if there is no indication to the contrary
from the Agency in accordance with Article 20(2) within the
three months following that deadline, without prejudice to
Article 27(8).

the submission date or,

In the case of an update of a registration according to Article
22 a registrant may continue the manufacture or import of a
substance, if there is no indication to the contrary from the
Agency in accordance with Article 20(2) within the three
weeks after the update date, without prejudice to Article 27(8).

2.
If the Agency has informed the registrant that he is to
submit further information in accordance with the third sub-
paragraph of Article 20(2), the registrant may start the manu-
facture or import of a substance or production or import of an
article if there is no indication to the contrary from the Agency
within the three weeks after receipt by the Agency of the
further
information necessary to complete his registration,
without prejudice to Article 27(8).

(b) any change in the composition of the substance as given in

section 2 of Annex VI;

(c) changes in the annual or total quantities manufactured or
imported by him if these result in a change of tonnage
band, including cessation of manufacture or import;

(d) new identified uses and new uses advised against as in
section 3.7 of Annex VI for which the substance is manu-
factured or imported;

(e) new knowledge of the risks of the substance to human
health and/or the environment of which he may reasonably
be expected to have become aware which leads to changes
in the safety data sheet or the chemical safety report;

(f) any change in the classification and labelling of

the

substance;

(g) any update or amendment of the chemical safety report or

section 5 of Annex VI;

(h) the registrant identifies the need to perform a test listed in
Annex IX or Annex X, in which cases a testing proposal
shall be developed;

(i) any change in the access granted to information in the

registration.

The Agency shall communicate this information to the compe-
tent authority of the relevant Member State.

3.
If a registrant submits parts of the registration on behalf
of one or more other registrants, as provided for in Articles 11
the other registrants may manufacture the
or 19, any of
substance in the Community or import it only after the expiry
of the time-limit laid down in paragraph 1 or 2 of this Article
and provided that there is no indication to the contrary from

2.
A registrant shall submit to the Agency an update of the
registration containing the information required by the decision
made in accordance with Articles 39, 40 or 45 or take into
account a decision made in accordance with Articles 59 and
72, within the deadline specified in that decision. The Agency
shall notify the competent authority of the relevant Member
State that the information is available on its database.

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3.
check
The Agency shall undertake a completeness
according to Article 20(2) first and second subparagraphs of
each updated registration.
In cases where the update is in
accordance with Article 12(2) and with paragraph 1(c) of this
Article then the Agency shall check the completeness of the
information supplied by the registrant and Article 20(2) shall
apply adapted as necessary.

In cases covered by Articles 11 or 19, each registrant
in

4.
shall
paragraph 1(c) of this Article.

information

separately

specified

submit

the

An update shall be accompanied by the relevant part of

5.
the fee required in accordance with Title IX.

CHAPTER 5

Transitional provisions applicable to phase-in substances and
notified substances

Article 23

Specific provisions for phase-in substances

Article 5, Article 6, Article 7(1) and Article 21 shall not

1.
apply until … (*) to the following substances:

(a) phase-in substances classified as carcinogenic, mutagenic or
toxic to reproduction, category 1 or 2, in accordance with
Directive 67/548/EEC and manufactured in the Community
or imported, in quantities reaching 1 tonne or more per
year per manufacturer or per importer, at least once after
… (**);

(b) phase-in substances classified as very toxic to aquatic
organisms which may cause long-term adverse effects in
in accordance with
the aquatic environment

(R50/53)

Directive 67/548/EEC, and manufactured in the Com-
munity or imported in quantities reaching 100 tonnes or
more per year per manufacturer or per importer, at least
once after … (**);

(c) phase-in substances manufactured in the Community or
imported, in quantities reaching 1 000 tonnes or more per
year per manufacturer or per importer, at least once after
… (**).

2.
Article 5, Article 6, Article 7(1) and Article 21 shall not
apply until … (***) to phase-in substances manufactured in the
Community or imported, in quantities reaching 100 tonnes or
more per year per manufacturer or per importer, at least once
after … (**).

3.
Article 5, Article 6, Article 7(1) and Article 21 shall not
apply until … (****) to phase-in substances manufactured in the
Community or imported,
in quantities reaching 1 tonne or
more per year per manufacturer or per importer, at least once
after … (**).

Article 24

Notified substances

1.
A notification in accordance with Directive 67/548/EEC
shall be regarded as a registration for the purposes of this Title
and the Agency shall assign a registration number by … (*****).

If the quantity of a notified substance manufactured or
2.
imported per manufacturer or
the next
tonnage threshold under Article 12, the additional required
information corresponding to that tonnage threshold, as well as
the lower tonnage thresholds, shall be submitted in
to all
accordance with Articles 10 and 12, unless it has already been
submitted in accordance with those Articles.

importer

reaches

DATA SHARING AND AVOIDANCE OF UNNECESSARY TESTING

TITLE III

CHAPTER 1

Objectives and general rules

Article 25

Objectives and general rules

of substances. Registrants shall refrain from exchanging infor-
mation concerning their market behaviour,
in particular as
regards production capacities, production or sales volumes,
import volumes or market shares.

Any study summaries or robust study summaries of
3.
studies submitted in the framework of a registration under this
Regulation at least 10 years previously can be used for the
purposes of registration by another manufacturer or importer.

CHAPTER 2

Rules for non-phase-in substances and registrants of phase-
in substances who have not pre-registered

1.
In order to avoid animal testing, testing on vertebrate
animals for the purposes of this Regulation shall be undertaken
only as a last resort.
It is also necessary to take measures
limiting duplication of other tests.

Article 26

Duty to inquire prior to registration

The sharing and joint submission of

2.
information in
accordance with this Regulation shall concern technical data
and in particular information related to the intrinsic properties

1.
Every potential registrant of a non-phase-in substance, or
potential registrant of a phase-in substance who has not pre-
registered in accordance with Article 28, shall inquire from the

(*) Three years after the entry into force of this Regulation.
(**) Date of entry into force of this Regulation.

(***) Six years after entry into force of this Regulation.
(****) 11 years after entry into force of this Regulation.
(*****) 18 months after entry into force of this Regulation.

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Agency whether a registration has already been submitted for
the same substance. He shall submit all the following informa-
tion to the Agency with the inquiry:

Such an agreement may be replaced by submission of the
matter to an arbitration board and acceptance of the arbitration
order.

(a) his identity as specified in section 1 of Annex VI, with the

exception of the use sites;

(b) the identity of the substance, as specified in section 2 of

Annex VI;

(c) which information requirements would require new studies
involving vertebrate animals to be carried out by him;

(d) which information requirements would require other new

studies to be carried out by him.

If the same substance has previously not been registered,

2.
the Agency shall inform the potential registrant accordingly.

If the same substance has previously been registered less
3.
than 10 years earlier, the Agency shall
inform the potential
registrant without delay of the names and addresses of the
previous registrant(s) and of the relevant summaries or robust
study summaries, as the case may be, already submitted by
them.

Studies involving vertebrate animals shall not be repeated.

The Agency shall simultaneously inform the previous regis-
trants of the name and address of the potential registrant. The
available studies shall be shared with the potential registrant in
accordance with Article 27.

3.
The previous registrant and potential registrant(s) shall
make every effort to ensure that the costs of sharing the infor-
mation are determined in a fair, transparent and non-discrimi-
natory way. This may be facilitated by following cost sharing
guidance based on those principles which is adopted by the
Agency in accordance with Article 76(2)(f). Registrants are only
required to share in the costs of information that they are
required to submit to satisfy their registration requirements.

4.
On agreement on the sharing of the information, the
previous registrant shall make available to the new registrant
the agreed information and shall give the new registrant the
permission to refer to the previous registrant's full study report.

5.
If there is failure to reach such an agreement, the poten-
tial registrant(s) shall inform the Agency and the previous regis-
trant(s) thereof at the earliest one month after receipt, from the
Agency, of the name and address of the previous registrant(s).

6. Within one month from the receipt of the information
referred to in paragraph 5, the Agency shall give the potential
registrant permission to refer to the information requested by
him in his registration dossier. Provided he makes the full study
report available to the potential registrant, the previous regis-
trant(s) shall have a claim on the potential registrant for an
equal share of the cost incurred by him, which shall be enforce-
able in the national courts.

4.
If several potential registrants have made an inquiry in
inform all
respect of the same substance, the Agency shall
potential registrants without delay of the name and address of
the other potential registrants.

An appeal may be brought, in accordance with Articles
7.
90, 91and 92, against Agency decisions under paragraph 6 of
this Article.

Article 27

The registration waiting period in accordance with
8.
Article 21(1) for the new registrant shall be extended by a
period of four months, if the previous registrant so requests.

Sharing of existing data in the case of

registered

substances

1. Where a substance has previously been registered less
than 10 years earlier as referred to in Article 26(3), the poten-
tial registrant:

(a) shall, in the case of information involving tests on verte-

brate animals; and

(b) may,

in the case of information not involving tests on

vertebrate animals,

from the previous registrant(s)

request
the information he
requires with respect to Article 10(a)(vi) and (vii) in order to
register.

2. When a request for information has been made according
to paragraph 1, the potential and the previous registrant(s) as
referred to in paragraph 1 shall make every effort to reach an
agreement on the sharing of the information requested by the
potential registrant(s) with respect to Article 10(a)(vi) and (vii).

CHAPTER 3

Rules for phase-in-substances

Article 28

Duty to pre-register for phase-in substances

In order to benefit from the transitional regime provided
1.
for
registrant of a phase-in
in Article 23 each potential
substance manufactured or imported in quantities of 1 tonne
or more per year, including without limitation intermediates,
shall submit all the following information to the Agency:

(a) the name of the substance as specified in section 2 of
Annex VI, including its EINECS and CAS number or, if not
available, any other identity codes;

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(b) his name and address and the name of the contact person
and, where appropriate,
the
person representing him in accordance with Article 4 as
specified in section 1 of Annex VI;

the name and address of

(c) the envisaged deadline for the registration/tonnage band;

(d) the name(s) of substance(s) as specified in section 2 of
Annex VI, including their EINECS and CAS number or, if
not available, any other identity codes, for which the avail-
able information is relevant for the application of sections
1.3 and 1.5 of Annex XI.

2.
The information referred to in paragraph 1 shall be
submitted within a time period starting on … (*)and ending on
… (**).

Registrants who do not submit the information required

3.
under paragraph 1 shall not be able to rely on Article 23.

4.
Potential registrants who manufacture or import for the
first time a phase-in substance in quantities of 1 tonne or more
per year after … (**), shall be entitled to rely on Article 23
provided that they submit the information referred to in para-
graph 1 of this Article to the Agency within six months of first
manufacturing or importing the substance and no later than 12
months before the relevant deadline in Article 23.

5.
The Agency shall by … (***) publish on its website a list
of the substances referred to in paragraph 1(a) and (d). That list
shall comprise only the names of the substances,
including
their EINECS and CAS number if available and other identity
codes.

6. Manufacturers or importers of phase-in substances in
quantities of less than 1 tonne per year that appear on the list
published by the Agency in accordance with paragraph 5 of
this Article, as well as downstream users of those substances
and third parties holding information on those substances, may
submit
the information referred to in paragraph 1 of this
Article or any other relevant information to the Agency for
those substances, with the intention of being part of
the
substance information exchange forum as referred to in Article
29.

Article 29

Substance Information Exchange Fora

1.
All manufacturers and importers who have submitted
information to the Agency in accordance with Article 28 for
the same phase-in substance shall be participants in a substance
information exchange forum (SIEF).

2.

The aim of each SIEF shall be to:

(a) facilitate, for the purposes of registration, the exchange of
the information specified in Article 10(a)
(vi) and (vii)
between manufacturers and importers, thereby avoiding the
duplication of studies; and

(b) agree classification and labelling where there is a difference

in the classification and labelling of the substance.

SIEF participants shall provide other participants with
3.
existing studies, react
to requests by other participants for
information, collectively identify needs for further studies and
arrange for them to be carried out. Each SIEF shall be opera-
tional until … (****).

Article 30

Sharing of data involving tests

1.
Before testing is carried out in order to meet the informa-
tion requirements for the purposes of registration, a SIEF parti-
cipant shall
inquire whether a relevant study is available by
communicating within his SIEF. If a relevant study involving
tests on vertebrate animals is available within the SIEF, a parti-
cipant of that SIEF shall request that study by … (*****). If a
relevant study not involving tests on vertebrate animals is avail-
able within the SIEF, a SIEF participant may request that study
by … (*****).

Within two weeks of the request, the owner of the study shall
provide proof of its cost to the participant(s) requesting it. The
participant(s) and the owner shall make every effort to ensure
that the costs of sharing the information are determined in a
fair, transparent and non discriminatory way. This may be
facilitated by following any cost sharing guidance which is
based on those principles and is adopted by the Agency in
accordance with Article 76(2)(f). If they cannot reach such an
agreement, the cost shall be shared equally. The owner shall
give permission to refer to the full study report for the purpose
of registration within two weeks of receipt of payment. Regis-
trants are only required to share in the costs of information
that they are required to submit to satisfy their registration
requirements.

2.
If a relevant study involving tests is not available within
the SIEF, only one study shall be conducted per information
requirement within each SIEF by one of its participants acting
on behalf of the others. They shall take all reasonable steps to
reach an agreement within a deadline set by the Agency as to
who is to carry out the test on behalf of the other participants
and to submit a summary or robust study summary to the
Agency. If no agreement is reached, the Agency shall specify
which registrant or downstream user shall perform the test. All

(*) 12 months after entry into force of this Regulation.
(**) 18 months after entry into force of this Regulation.
(***) 19 months after entry into force of this Regulation.

(****) 11 years after entry into force of this Regulation.
(*****) 20 months after entry into force of this Regulation.

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participants of the SIEF who require a study shall contribute to
the costs for the elaboration of the study with a share corre-
sponding to the number of participating potential registrants.
Those participants that do not carry out the study themselves
shall have the right to receive the full study report within two
weeks following payment to the participant that carried out the
study.

If the owner of a study as referred to in paragraph 1
3.
which involves testing on vertebrate animals refuses to provide
either proof of the cost of that study or the study itself to
(an)other participant(s), he shall not be able to proceed with
registration until he provides the information to the other
participants(s). The other participant(s) shall proceed with regis-
tration without fulfilling the relevant information requirement,
explaining the reason for this in the registration dossier. The
study shall not be repeated unless within 12 months of the
date of registration of the other participant(s), the owner of this
information has not provided it
to them and the Agency
decides that the test should be repeated by them. However, if a
information has already been
registration containing this
the Agency shall give the
submitted by another registrant,

other participant(s) permission to refer to the information in
his registration dossier(s). The other registrant shall have a
claim on the other participant(s) for an equal share of the cost,
provided he makes the full study report available to the other
participant(s), which shall be enforceable in the national courts.

4.
If the owner of a study as referred to in paragraph 1
which does not involve testing on vertebrate animals refuses to
provide either proof of the cost of that study or the study itself
to (an)other participant(s),
the other SIEF participants shall
proceed with registration as if no relevant study was available
in the SIEF.

5.
An appeal may be brought, in accordance with Articles
90, 91 and 92, against Agency decisions under paragraphs 2
or 3 of this Article.

6.
The owner of the study who has refused to provide either
proof of the cost or the study itself, as referred to in paragraph
3 or 4 of this Article, shall be penalised in accordance with
Article 125.

TITLE IV

INFORMATION IN THE SUPPLY CHAIN

Article 31

as dangerous in accordance with Articles 5, 6 and 7 of
Directive 1999/45/EC, but contains:

Requirements for Safety Data Sheets

The supplier of a substance or a preparation shall provide
1.
the recipient of the substance or preparation with a safety data
sheet compiled in accordance with Annex II:

(a) where a substance or preparation meets the criteria for clas-
with

sification
Directives 67/548/EEC or 1999/45/EC; or

accordance

dangerous

as

in

(b) where a substance is persistent, bioaccumulative and toxic
or very persistent and very bioaccumulative in accordance
with the criteria set out in Annex XIII.

2.
Any actor in the supply chain who is required, under
Articles 14 or 36, to carry out a chemical safety assessment for
a substance shall ensure that the information in the safety data
sheet is consistent with the information in this assessment. If
the safety data sheet is developed for a preparation and the
actor in the supply chain has prepared a chemical safety assess-
ment for that preparation, it is sufficient if the information in
the safety data sheet is consistent with the chemical safety
report for the preparation instead of with the chemical safety
report for each substance in the preparation.

(a) in an individual concentration of ≥ 1 % by weight for non-
gaseous preparations and ≥ 0,2 % by volume for gaseous
preparations at least one substance posing human health or
environmental hazards; or

(b) in an individual concentration of ≥ 0,1 % by weight for
is
non-gaseous preparations at
persistent, bioaccumulative and toxic or very persistent and
very bioaccumulative in accordance with the criteria set out
in Annex XIII; or

least one substance that

(c) a substance for which there are Community workplace

exposure limits.

4.
The safety data sheet need not be supplied where
dangerous substances or preparations offered or sold to the
general public are provided with sufficient
information to
enable users to take the necessary measures as regards the
protection of human health, safety and the environment, unless
requested by a downstream user or distributor.

3.
The supplier shall provide the recipient at his request
with a safety data sheet compiled in accordance with Annex II,
where a preparation does not meet the criteria for classification

The safety data sheet shall be supplied in an official
5.
language of
the Member State(s) where the substance or
preparation is placed on the market, unless the Member State(s)
concerned provide otherwise.

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The safety data sheet shall be dated and shall contain the

6.
following headings:

(c) once a restriction has been imposed.

1.

identification of
company/undertaking;

the substance/preparation and of

the

2. hazards identification;

3. composition/information on ingredients;

4. first-aid measures;

5. fire-fighting measures;

6. accidental release measures;

7. handling and storage;

8. exposure controls/personal protection;

9. physical and chemical properties;

10. stability and reactivity;

11. toxicological information;

12. ecological information;

13. disposal considerations;

14. transport information;

15. regulatory information;

16. other information.

7.
Any actor in the supply chain who is required to prepare
a chemical safety report according to Articles 14 or 36 shall
place the relevant exposure scenarios (including use and expo-
sure categories where appropriate) in an annex to the safety
data sheet covering identified uses and including specific condi-
tions resulting from the application of section 3 of Annex XI.

Any downstream user shall include relevant exposure scenarios,
and use other relevant information, from the safety data sheet
supplied to him when compiling his own safety data sheet for
identified uses.

Any distributor shall pass on relevant exposure scenarios, and
use other relevant
from the safety data sheet
supplied to him when compiling his own safety data sheet for
uses for which he has passed on information according to
Article 36(2).

information,

The new, dated version of the information, identified as ‘Revi-
sion: (date)’, shall be provided free of charge on paper or elec-
tronically to all former recipients to whom they have supplied
the substance or preparation within the preceding 12 months.
Any updates following registration shall include the registration
number.

Article 32

Duty to communicate information down the supply chain
for substances on their own or in preparations for which
a safety data sheet is not required

1.
Any supplier of a substance on its own or in a prepara-
tion who does not have to supply a safety data sheet in accord-
ance with Article 31 shall provide the recipient with the
following information:

(a) the registration number(s) referred to in Article 20(3),

if
for any substances for which information is
available,
communicated under points (b), (c) or (d) of this paragraph;

(b) if 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

the
is necessary to enable appropriate risk
substance that
management measures
identified and applied
to be
including specific conditions resulting from the application
of section 3 of Annex XI.

information about

2.
The information referred to in paragraph 1shall be
communicated free of charge on paper or electronically at the
latest at the time of the first delivery of a substance on its own
or in a preparation after … (*).

Suppliers shall update this information without delay on

3.
the following occasions:

(a) as soon as new information which may affect the risk
management measures, or new information on hazards
becomes available;

A safety data sheet shall be provided free of charge on

8.
paper or electronically.

(b) once an authorisation has been granted or refused;

(c) once a restriction has been imposed.

Suppliers shall update the safety data sheet without delay

9.
on the following occasions:

(a) as soon as new information which may affect the risk
management measures, or new information on hazards
becomes available;

In addition, the updated information shall be provided free of
charge on paper or electronically to all former recipients to
whom they have supplied the substance or preparation within
the preceding 12 months. Any updates following registration
shall include the registration number.

(b) once an authorisation has been granted or refused;

(*) Date of entry into force of this Regulation.

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to Article 58(1)

4.
Any producer or importer of an article containing a
substance meeting the criteria in Article 56 and identified
according
concentration above
0,1 % weight by weight (w/w), shall provide the recipient of the
article with sufficient information to allow safe use of the
article including, as a minimum, the name of the substance.
This obligation shall extend to all recipients of articles in the
supply chain.

in a

Article 33

Duty to communicate information on substances and
preparations up the supply chain

Any actor in the supply chain of a substance or a preparation
shall communicate the following information to the next actor
or distributor up the supply chain:

(a) new information on hazardous properties, regardless of the

uses concerned;

(b) any other information that might call

into question the
appropriateness of the risk management measures identified
in a safety data sheet supplied to him, which shall be
communicated only for identified uses.

Distributors shall pass on that information to the next actor or
distributor up the supply chain.

Article 34

Access to information for workers

Workers and their representatives shall be granted access by
their employer to the information provided in accordance with
Articles 31 and 32 in relation to substances or preparations
that they use or may be exposed to in the course of their work.

Article 35

Obligation to keep information

1.
Each manufacturer, importer, downstream user and distri-
butor shall assemble and keep available all the information he
requires to carry out his duties under this Regulation for a
period of at least 10 years after he last manufactured, imported,
supplied or used the substance or preparation. That manufac-
importer, downstream user or distributor shall submit
turer,
this information or make it available without delay upon
request to any competent authority of the Member State in
which he is established or to the Agency, without prejudice to
Titles II and VI.

2.
In the event of a registrant ceasing activity, or transferring
part or all of his operations to a third party, the party respon-
sible for liquidating the registrant's undertaking or assuming
responsibility for the placing on the market of the substance or
preparation concerned shall be bound by the obligation in
paragraph 1 in place of the registrant.

TITLE V

DOWNSTREAM USERS

Article 36

Downstream user chemical safety assessments and duty to
identify, apply and recommend risk reduction measures

A downstream user or distributor may provide informa-

1.
tion to assist in the preparation of a registration.

Any downstream user shall have the right to make a use,
2.
as a minimum the brief general description of use, known in
writing (on paper or electronically)
to the manufacturer,
importer, downstream user or distributor who supplies him
with a substance on its own or in a preparation with the aim
of making this an identified use. In making a use known, he
shall provide sufficient information to allow the manufacturer,
importer or downstream user who has supplied the substance,
to prepare an exposure scenario, or if appropriate a use and
exposure category, for his use in the manufacturer, importer or
downstream user's chemical safety assessment.

Distributors shall pass on such information to the next actor or
distributor up the supply chain. Downstream users in receipt of
such information may prepare an exposure scenario for the
identified use(s), or pass the information to the next actor up
the supply chain.

3.
For registered substances, the manufacturer, importer or
downstream user shall comply with the obligations laid down

in Article 14 either before he next supplies the substance on its
own or in a preparation to the downstream user making the
request referred to in paragraph 2 of this Article, provided that
the request was made at least one month before the supply, or
within one month after the request, whichever is the later.

For phase-in substances, the manufacturer, importer or down-
stream user shall comply with this request and with the obliga-
tions laid down in Article 14 before the relevant deadline in
Article 23 has expired, provided that the downstream user
makes his request at least 12 months before the deadline in
question.

Where the manufacturer, importer or downstream user, having
assessed the use in accordance with Article 14, is unable to
include it as an identified use for reasons of protection of
human health or the environment, he shall provide the Agency
and the downstream user with the reason(s) for that decision in
writing without delay and shall not supply downstream user(s)
with the substance without including these reason(s)
in the
information referred to under Articles 31 or 32. The manufac-
turer or importer shall include this use in section 3.7 of Annex
VI
the registration in accordance with
Article 22(1)(d).

in his update of

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4.
A downstream user of a substance on its own or in a
preparation shall prepare a chemical safety report in accord-
ance with Annex XII
for any use outside the conditions
described in an exposure scenario or if appropriate a use and
exposure category communicated to him in a safety data sheet
or for any use his supplier advises against.

A downstream user need not prepare such a chemical safety
report in any of the following cases:

(a) a safety data sheet is not required to be communicated with
the substance or preparation in accordance with Article 31;

(b) a chemical safety report is not required to be completed by

his supplier in accordance with Article 14;

(c) the downstream user uses the substance or preparation in a

total quantity of less than 1 tonne per year;

(d) the downstream user implements or recommends an expo-
sure scenario which includes as a minimum the conditions
described in the exposure scenario communicated to him
in the safety data sheet;

(e) the substance is present in a preparation in a concentration
lower than any of the concentrations set out in Article
14(2);

(f) the downstream user

is using the substance for

the
purposes of product and process oriented research and
development, provided that the risks to human health and
the environment are adequately controlled in accordance
with the requirements of legislation for the protection of
workers and the environment.

Article 37

Obligation for downstream users to report information

1.
Before commencing or continuing with a particular use
of a substance that has been registered by an actor up the
supply chain in accordance with Articles 6 or 18, the down-
stream user shall report to the Agency the information speci-
fied in paragraph 2 of this Article, in the following cases:

(a) the downstream user has to prepare a chemical safety

report in accordance with Article 36(4); or

(b) the downstream user is relying on the exemptions in

Article 36(4)(c) or (f).

The information reported by the downstream user shall

2.
include the following:

(a) his identity and contact details as specified in section 1.1 of

Annex VI;

(b) the registration number(s) referred to in Article 20(3),

if

available;

(c) the identity of the substance(s) as specified in section 2.1 to

2.3.4 of Annex VI;

(d) the identity of the manufacturer(s) or the importer(s) or
other supplier as specified in section 1.1 of Annex VI;

(e) a brief general description of the use(s), as specified in
section 3.5 of Annex VI, and of the conditions of use(s);

(f) except where the downstream user is relying on the exemp-
tion in Article 36(4)(c), a proposal for additional testing on
vertebrate animals, where this is considered necessary by
to complete his chemical safety
the downstream user
assessment.

Any downstream user shall

5.
suitable,
recommend, appropriate measures
control risks identified in any of the following:

identify, apply and where
to adequately

The downstream user

3.
information
without delay in the event of a change in the information
reported in accordance with paragraph 1.

shall update this

(a) the safety data sheet(s) supplied to him;

(b) his own chemical safety assessment;

(c) any information on risk management measures supplied to

him in accordance with Article 32.

6. Where a downstream user does not prepare a chemical
safety report
in accordance with paragraph 4(c), he shall
consider the use(s) of the substance and identify and apply any
appropriate risk management measures needed to ensure that
the risks to human health and the environment are adequately
controlled. Where necessary, this information shall be included
in any safety data sheet prepared by him.

Downstream users shall keep their chemical safety report

7.
up to date and available.

A downstream user shall report to the Agency if his clas-

4.
sification of a substance is different to that of his supplier.

5.
Except where a downstream user is relying on the exemp-
tion in Article 36(4)(c), reporting in accordance with para-
graphs 1 to 4 of this Article shall not be required in respect of
a substance, on its own or in a preparation, used by the down-
stream user in quantities of less than 1 tonne per year for that
particular use.

Article 38

Application of downstream user obligations

1.
Downstream users shall be required to comply with the
the latest 12 months after
requirements of Article 36 at
receiving a registration number communicated to them by
their suppliers in a safety data sheet.

A chemical safety report prepared in accordance with
8.
paragraph 4 of this Article need not include consideration of
the risks to human health from the end uses set out
in
Article 14(5).

Downstream users shall be required to comply with the
2.
requirements of Article 37 at
the latest six months after
receiving a registration number communicated to them by
their suppliers in a safety data sheet.

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TITLE VI

EVALUATION

CHAPTER 1

Article 40

Dossier evaluation

Compliance check of registrations

Article 39

Examination of testing proposals

1.
The Agency shall examine any testing proposal set out in
a registration or a downstream user report for provision of the
information specified in Annexes IX and X for a substance.
Priority shall be given to registrations of substances which have
or may have PBT, vPvB, sensitising and/or carcinogenic, muta-
genic or toxic for reproduction (CMR) properties, or substances
classified as dangerous according to Directive 67/548/EEC
above 100 tonnes per year with uses resulting in widespread
and diffuse exposure.

2.
On the basis of the examination under paragraph 1, the
Agency shall draft one of the following decisions and that deci-
sion shall be taken in accordance with the procedure laid down
in Articles 49 and 50:

(a) a decision requiring the registrant(s) or downstream user(s)
concerned to carry out the proposed test and setting a
the study summary, or the
deadline for submission of
robust study summary if required by Annex I;

(b) a decision in accordance with point (a), but modifying the

conditions under which the test is to be carried out;

(c) a decision in accordance with points (a),

(b) or (d) but
requiring registrant(s) or downstream user(s) to carry out
one or more additional tests in cases of non-compliance of
the testing proposal with Annexes IX, X and XI;

The Agency may examine any registration in order to

1.
verify any of the following:

(a) that the information in the technical dossier(s) submitted
pursuant to Article 10 complies with the requirements of
Articles 10, 12 and 13 and with Annexes III and VI to X;

(b) that the adaptations of the standard information require-
ments and the related justifications submitted in the tech-
nical dossier(s) comply with the rules governing such adap-
tations set out in Annexes VII to X and with the general
rules set out in Annex XI;

(c) that any required chemical safety assessment and chemical
safety report comply with the requirements of Annex I and
that the proposed risk management measures are adequate;

(d) that any explanation(s)

submitted in accordance with

Article 11(3) or Article 19(2) have an objective basis.

The list of dossiers being checked for compliance by the
2.
Agency shall be made available to Member States competent
authorities.

3.
On the basis of an examination made pursuant to para-
graph 1, the Agency may, within 12 months of the start of the
compliance check, prepare a draft decision requiring the regis-
trant(s) to submit any information needed to bring the registra-
tion(s) into compliance with the relevant information require-
ments and specifying adequate time limits for the submission
of
further information. Such a decision shall be taken in
accordance with the procedure laid down in Articles 49 and
50.

(d) a decision rejecting the testing proposal;

The registrant shall submit the information required to

4.
the Agency by the deadline set.

(e) a decision in accordance with points (a), (b) or (c), if several
registrants of the same substance have submitted proposals
for the same test, giving them the opportunity to reach an
agreement on who will perform the test on behalf of all of
them and to inform the Agency accordingly within 90
days. If the Agency is not informed of such agreement
within such 90 days, it shall designate one of the registrants
to perform the test on behalf of all of them.

To ensure that registration dossiers comply with this
5.
those
the Agency shall select a percentage of
Regulation,
dossiers, no lower than 5 % of the total received by the Agency
for each tonnage band, for compliance checking. The Agency
shall give priority, but not exclusively, to dossiers meeting at
least one of the following criteria:

The registrant or downstream user shall submit the infor-

3.
mation required to the Agency by the deadline set.

(a) the dossier contains information in Article 10(a)(iv),
and/or (vii) submitted separately as per Article 11(3); or

(vi)

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(b) the dossier is for a substance manufactured or imported in
quantities of 1 tonne or more per year and does not meet
the requirements of Annex VII applying under either
Article 12(1)(a) or (b), as the case may be; or

(c) the dossier is for a substance listed in the Community

rolling action plan referred to in Article 43(2).

Any third party may electronically submit information to
6.
the Agency relating to substances that appear on the list
referred to in Article 28(5). The Agency shall consider this
information together with the information submitted according
to Article 123 when checking and selecting dossiers.

7.
The Commission may, after consulting with the Agency,
take a decision to vary the percentage of dossiers selected and
amend or include further criteria in paragraph 5 in accordance
with the procedure referred to in Article 132(3).

Article 41

Check of information submitted and follow-up to dossier
evaluation

The Agency shall examine any information submitted in
1.
consequence of a decision taken under Articles 39 or 40, and
draft any appropriate decisions in accordance with these Arti-
cles, if necessary.

2.
Once the dossier evaluation is completed, the Agency
shall notify the Commission and the competent authorities of
the Member States of the information obtained and any conclu-
sions made. The competent authorities shall use the informa-
tion obtained from this evaluation for the purposes of Article
44(5), Article 58(3) and Article 68(4). The Agency shall use the
information obtained from this evaluation for the purposes of
Article 43.

Article 42

Procedure and time periods for examination of testing
proposals

1.
In the case of non phase-in substances, the Agency shall
prepare a draft decision in accordance with Article 39(2)
within 180 days of receiving a registration or downstream user
report containing a testing proposal.

In the case of phase-in substances,

2.
prepare the draft decisions in accordance with Article 39(2):

the Agency shall

(a) by … (*) for all registrations received by … (**) containing
the information

proposals for testing in order to fulfil
requirements in Annexes IX and X;

(b) by … (***)

for all

received by … (****)
registrations
containing proposals for testing in order to fulfil the infor-
mation requirements in Annex IX only;

(c) by … (*****) for any registrations containing testing propo-

sals received by … (******).

The list of registration dossiers being evaluated under

3.
Article 39 shall be made available to Member States.

CHAPTER 2

Substance evaluation

Article 43

Criteria for substance evaluation

1.
In order to ensure a harmonised approach, the Agency
shall in cooperation with the Member States develop criteria
for prioritising substances with a view to further evaluation.
Prioritisation shall be on a risk-based approach. The criteria
shall consider:

(a) hazard information, for instance structural similarity of the
substance with known substances of concern or with
substances which are persistent and liable to bio-accumu-
late, suggesting that the substance or one or more of its
transformation products has properties of concern or is
persistent and liable to bio-accumulate;

(b) exposure information;

(c) tonnage,

including aggregated tonnage from the registra-

tions submitted by several registrants.

2.
The Agency shall use the criteria in paragraph 1 for the
purpose of compiling a draft Community rolling action plan
which shall cover a period of three years and shall specify
substances to be evaluated each year. Substances shall be
included if there are grounds for considering (either on the
basis of a dossier evaluation carried out by the Agency or on
the basis of any other appropriate source, including informa-
tion in the registration dossier) that a given substance consti-
tutes a risk to human health or the environment. The Agency
shall submit the first draft rolling action plan to the Member
States by … (*******). The Agency shall submit draft annual
updates to the rolling action plan to the Member States by 28
February each year.

The Agency shall adopt the final Community rolling action
plan on the basis of an opinion from the Member State
Committee set up under Article 75(1)(e) (hereinafter referred to
as ‘the Member State Committee’) and shall publish the plan on
its website, identifying the Member State who will carry out the
evaluation of
listed therein as determined
according to Article 44.

the substances

(*) Five years after entry into force of this Regulation.
(**) Three years after the entry into force of this Regulation.
(***) Nine years after entry into force of this Regulation.
(****) Six years after entry into force of this Regulation.

(*****) 15 years after entry into force of this Regulation.
(******) 11 years after entry into force of this Regulation.
(*******) Four years after entry into force of this Regulation.

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Article 44

Competent authority

whether to add this substance to the Community rolling action
plan on the basis of an opinion from the Member State
Committee. If the substance is added to the Community rolling
action plan, the proposing Member State, or another Member
State who agrees, shall evaluate that substance.

The Agency shall be responsible for coordinating the
1.
substance evaluation process and ensuring that substances on
the Community rolling action plan are evaluated. In doing so,
the Agency shall rely on the competent authorities of Member
States. In carrying out an evaluation of a substance, the compe-
tent authorities may appoint another body to act on their
behalf.

A Member State may choose (a) substance(s) from the
2.
draft Community rolling action plan, with the aim of becoming
a competent authority for the purposes of Articles 45, 46 and
47. In the event of a substance from the draft Community
rolling action plan not being chosen by any Member State, the
Agency shall ensure that the substance is evaluated.

3.
In cases where two or more Member States have
expressed an interest in evaluating the same substance and they
cannot agree who should be the competent authority,
the
competent authority for the purposes of Articles 45, 46 and 47
shall be determined in accordance with the following proce-
dure.

refer

the matter

to the Member State
The Agency shall
in order to agree which authority shall be the
Committee,
competent authority, taking into account the Member State in
which the manufacturer(s) or importer(s) is located, the respec-
tive proportions of total Community gross domestic product,
the number of substances already being evaluated by a Member
State and the expertise available.

If, within 60 days of the referral, the Member State Committee
reaches unanimous agreement, the Member States concerned
shall adopt substances for evaluation accordingly.

If the Member State Committee fails to reach a unanimous
agreement, the Agency shall submit the conflicting opinions to
the Commission, which shall decide which authority shall be
the competent authority,
in accordance with the procedure
referred to in Article 132(3), and the Member States concerned
shall adopt substances for evaluation accordingly.

4.
The competent authority identified in accordance with
paragraphs 2 and 3 shall evaluate the allocated substances in
accordance with this Chapter.

A Member State may notify the Agency at any time of a
5.
substance not on the Community rolling action plan, whenever
it
the
substance is a priority for evaluation. The Agency shall decide

information which suggests that

is in possession of

Article 45

Requests for further information and check of information
submitted

including,

if appropriate,

If the competent authority considers that further informa-
1.
tion is required,
information not
required in Annexes VII to X, it shall prepare a draft decision,
stating reasons, requiring the registrant(s) to submit the further
information and setting a deadline for its submission. A draft
decision shall be prepared within 12 months of the publication
of the Community rolling action plan on the Agency's website
for substances to be evaluated that year. The decision shall be
taken in accordance with the procedure laid down in Articles 49
and 51.

The registrant shall submit the information required to

2.
the Agency by the deadline set.

3.
The competent authority shall examine any information
submitted, and shall draft any appropriate decisions in accord-
ance with this Article, if necessary, within 12 months of the
information being submitted.

The competent authority shall finish its evaluation activ-
4.
ities within 12 months of the start of the evaluation of the
substance or within 12 months of
the information being
submitted under paragraph 2, and notify the Agency accord-
ingly.
the evaluation shall be
deemed to be finished.

this deadline is exceeded,

If

Article 46

Coherence with other activities

1.
An evaluation of a substance shall be based on all rele-
vant information submitted on that particular substance and on
any previous evaluation under this Title. Where information on
intrinsic properties of a substance has been generated by refer-
ence to structurally related substance(s), the evaluation may
also cover these related substances. In cases where a decision
on an evaluation has been previously taken in accordance with
Article 50 or Article 51, any draft decision requiring further
information under Article 45 may be justified only by a change
of circumstances or acquired knowledge.

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2.
In order to ensure a harmonised approach to requests for
further information, the Agency shall monitor draft decisions
under Article 45 and shall develop criteria and priorities.
Where appropriate, implementing measures shall be adopted in
accordance with the procedure referred to in Article 132(3).

CHAPTER 4

Common provisions

Article 47

Article 49

Follow-up to substance evaluation

Registrants' and downstream users' rights

Once the substance evaluation has been completed, the compe-
tent authority shall consider how to use the information
obtained from this evaluation for the purposes of Article 58(3),
Article 68(4) and Article 114(1). The competent authority shall
inform the Agency of its conclusions as to whether or how to
use the information obtained. The Agency shall in turn inform
the Commission, the registrant and the competent authorities
of the other Member States.

CHAPTER 3

Evaluation of intermediates

Article 48

Further information on on-site isolated intermediates

For on-site isolated intermediates that are used in strictly
controlled conditions, neither dossier nor substance evaluation
shall apply. However, where the competent authority of the
Member State in whose territory the site is located considers
that a risk to human health or the environment, equivalent to
the level of concern arising from the use of substances meeting
the criteria in Article 56, arises from the use of an on-site
isolated intermediate and that risk is not properly controlled, it
may:

The Agency shall notify any draft decision under Articles
1.
39, 40 or 45 to the registrant(s) or downstream user(s)
concerned, informing them of their right to comment within
30 days of receipt. If the concerned registrant(s) or downstream
user(s) wish to comment, they shall provide their comments to
the Agency. The Agency in turn shall inform the competent
authority of the submission of the comments without delay.
The competent authority (for decisions taken under Article 45)
and the Agency (for decisions taken under Articles 39 and 40)
shall take any comments received into account and may amend
the draft decision accordingly.

If a registrant has ceased the manufacture or import of
2.
the substance, he shall inform the Agency of this fact with the
consequence that the registered volume in his registration shall
be put to zero and no further information may be requested
with respect to that substance, unless the registrant notifies the
restart of the manufacture or import of the substance. The
Agency shall inform the competent authority of the Member
State in which the manufacturer or importer is located.

3.
The registrant may cease the manufacture or import of
the substance upon receipt of the draft decision. In such cases,
he shall inform the Agency of this fact with the consequence
that his registration shall no longer be valid, and no further
information may be requested with respect to that substance,
unless he submits a new registration. The Agency shall inform
the competent authority of the Member State in which the
manufacturer or importer is located.

(a) require the registrant to submit further information directly
related to the risk identified. This request shall be accompa-
nied by a written justification;

4.
Notwithstanding paragraphs 2 and 3, further information
may be required in accordance with Article 45 in either or
both of the following cases:

(b) examine any information submitted and,

if necessary,
recommend any appropriate risk reduction measures to
address the risks identified in relation to the site in ques-
tion.

(a) where the competent authority prepares a dossier

in
accordance with Annex XV concluding that
there is a
potential long-term risk to human health or the environ-
ment justifying the need for further information;

The procedure provided for in the first paragraph may be
undertaken only by the competent authority referred to
therein. The competent authority shall inform the Agency of
the results of such an evaluation, which shall then inform the
competent authorities of the other Member States and make
the results available to them.

(b) where the exposure to the substance manufactured or
imported by the registrant(s) concerned contributes signifi-
cantly to that risk.

The procedure in Articles 68 to 72 shall apply mutatis mutandis.

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Article 50

Article 52

Adoption of decisions under dossier evaluation

1.
The Agency shall notify its draft decision in accordance
with Articles 39 or 40, together with the comments of the
registrant, to the competent authorities of the Member States.

2. Within 30 days of circulation, the Member States may
propose amendments to the draft decision to the Agency.

If the Agency does not receive any proposals, it shall take

3.
the decision in the version notified under paragraph 1.

4.
If the Agency receives a proposal for amendment, it may
modify the draft decision. The Agency shall refer a draft deci-
sion, together with any amendments proposed, to the Member
State Committee within 15 days of the end of the 30-day
period referred to in paragraph 2.

The Agency shall forthwith communicate any proposal
5.
for amendment
to any registrants or downstream users
concerned and allow them to comment within 30 days. The
Member State Committee shall take any comments received
into account.

If, within 60 days of

6.
the Member State
Committee reaches a unanimous agreement on the draft deci-
sion, the Agency shall take the decision accordingly.

the referral,

7.
If the Member State Committee fails to reach unanimous
agreement, the Commission shall prepare a draft decision to be
taken in accordance with the procedure referred to in
Article 132(3).

8.
An appeal may be brought, in accordance with Articles
90, 91 and 92, against Agency decisions under paragraphs 3
and 6 of this Article.

Cost sharing for tests without an agreement between
registrants and/or downstream users

1. Where registrants or downstream users are required to
perform a test as a result of a decision taken under this Title,
those registrants or downstream users shall make every effort
to reach an agreement as to who is to carry it out on behalf of
the other registrants or downstream users and to inform the
Agency accordingly within 90 days.
the Agency is not
informed of such agreement within such 90 days, it shall desig-
nate one of the registrants or downstream users to perform the
test on behalf of all of them.

If

2.
If a registrant or downstream user performs a test on
behalf of others, they shall all share the cost of that study
equally.

3.
In the case referred to in paragraph 1, the registrant or
downstream user who performs the test shall provide each of
the others concerned with a copy of the full study report.

4.
The person performing and submitting the study shall
the others accordingly. Any person
have a claim against
concerned shall be able to make a claim in order to prohibit
another person from manufacturing, importing or placing the
substance on the market if that other person either fails to pay
his share of the cost or to provide security for that amount or
fails to hand over a copy of the full study report of the study
performed. All claims shall be enforceable in the national
courts. Any person may choose to submit their claims for
remuneration to an arbitration board and accept the arbitration
order.

Article 51

Article 53

Adoption of decisions under substance evaluation

Publication of information on evaluation

The competent authority shall circulate its draft decision
1.
in accordance with Article 45, together with any comments by
the registrant or downstream user, to the Agency and to the
competent authorities of the other Member States.

The provisions of Article 50(2) to (8) shall apply mutatis

2.
mutandis.

By 28 February of each year, the Agency shall publish on its
website a report on the progress made over the previous
calendar year towards discharging the obligations incumbent
upon it in relation to evaluation. This report shall include, in
particular, recommendations to potential registrants in order to
improve the quality of future registrations.

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TITLE VII

AUTHORISATION

CHAPTER 1

Authorisation requirement

Article 54

Aim of authorisation

The aim of this Title is to ensure the good functioning of the
internal market while assuring that the risks from substances of
very high concern are properly controlled and that
these
substances are eventually replaced by suitable alternative
substances or technologies where these are economically and
technically viable.

accordance with the conditions of an authorisation granted to
an actor up his supply chain for that use.

3.
Paragraphs 1 and 2 shall not apply to the use of
substances in scientific research and development. Annex XIV
shall specify if paragraphs 1 and 2 apply to product and
process orientated research and development as well as the
maximum quantity exempted.

Paragraphs 1 and 2 shall not apply to the following uses

4.
of substances:

(a) uses in plant protection products within the scope of

Directive 91/414/EEC;

(b) uses

in
Directive 98/8/EC;

biocidal

products within

the

scope

of

Article 55

General provisions

(c) use as motor fuels covered by Directive 98/70/EC of the
European Parliament and of the Council of 13 October
1998 relating to the quality of petrol and diesel fuels and
amending Council Directive 93/12/EEC (1);

1.
A manufacturer, importer or downstream user shall not
place a substance on the market for a use or use it himself if
that substance is included in Annex XIV, unless:

(a) the use(s) of that substance on its own or in a preparation
or the incorporation of the substance into an article for
which the substance is placed on the market or for which
he uses the substance himself has been authorised in
accordance with Articles 59 to 63; or

(b) the use(s) of that substance on its own or in a preparation
or the incorporation of the substance into an article for
which the substance is placed on the market or for which
he uses the substance himself has been exempted from the
authorisation requirement in Annex XIV itself in accord-
ance with Article 57(2); or

(d) uses as fuel

in mobile or fixed combustion plants of

mineral oil products and use as fuels in closed systems.

5.
In the case of substances that are subject to authorisation
only because they meet the criteria in Article 56(a), (b) or (c) or
because they are identified in accordance with Article 56(f)
only because of hazards to human health, paragraphs 1 and 2
of this Article shall not apply to the following uses:

(a) uses

in

cosmetic

products within

the

scope

of

Directive 76/768/EEC;

(b) uses in food contact materials within the scope of Regu-

lation (EC) No 1935/2004.

(c) the date referred to in Article 57(1)(c)(i) has not been

reached; or

Paragraphs 1 and 2 shall not apply to the use of

6.
substances when they are present in preparations:

(d) the date referred to in Article 57(1)(c)(i) has been reached
and he made an application 18 months before that date
but a decision on the application for authorisation has not
yet been taken; or

(a) for substances referred to in Article 56(d), (e) and (f), below
a concentration limit of 0,1 % weight by weight (w/w);

(e) in cases where the substance is placed on the market,
that use has been granted to his

authorisation for
immediate downstream user.

(b) for all other substances, below the lowest of the concentra-
tion limits specified in Directive 1999/45/EC or in Annex I
to Directive 67/548/EEC which result in the classification
of the preparation as dangerous.

2.
A downstream user may use a substance meeting the
criteria set out in paragraph 1 provided that the use is in

(1) OJ L 350, 28.12.1998, p. 58. Directive as last amended by Regu-

lation (EC) No 1882/2003.

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Article 56

Substances to be included in Annex XIV

The following substances may be included in Annex XIV in
accordance with the procedure laid down in Article 57:

(a) substances meeting the criteria for classification as carcino-
accordance with

or

in

2

genic
1
Directive 67/548/EEC;

category

(b) substances meeting the criteria for classification as muta-
accordance with

or

in

2

genic
1
Directive 67/548/EEC;

category

(c) substances meeting the criteria for classification as toxic for
reproduction category 1 or 2 in accordance with
Directive 67/548/EEC;

(d) substances which are persistent, bioaccumulative and toxic
in accordance with the criteria set out in Annex XIII of this
Regulation;

(e) substances which are very persistent and very bioaccumula-
tive in accordance with the criteria set out in Annex XIII of
this Regulation;

(f) substances — such as those having endocrine disrupting
properties or those having persistent, bioaccumulative and
toxic properties or very persistent and very bioaccumulative
properties, which do not fulfil the criteria of points (d) or
(e) — for which there is scientific evidence of probable
serious effects to human health or the environment which
give rise to an equivalent level of concern to those of other
substances listed in points (a) to (e) and which are identified
on a case-by-case basis in accordance with the procedure
set out in Article 58.

Article 57

Inclusion of substances in Annex XIV

1. Whenever a decision is taken to include in Annex XIV
substances referred to in Article 56, such a decision shall be
taken in accordance with the procedure referred to in
Article 132(3). It shall specify for each substance:

(a) the identity of the substance as specified in section 2 of

Annex VI;

(b) the intrinsic property (properties) of the substance referred

to in Article 56;

(c) transitional arrangements:

(ii) a date or dates at least 18 months before the sunset
date(s) by which applications must be received if the
applicant wishes to continue to use the substance or
place it on the market for certain uses after the sunset
date(s); these continued uses shall be allowed after the
sunset date until a decision on the application for
authorisation is taken;

(d) review periods for certain uses, if appropriate;

(e) uses or categories of uses exempted from the authorisation
requirement, if any, and conditions for such exemptions, if
any.

2.
Uses or categories of uses may be exempted from the
authorisation requirement provided that, on the basis of the
existing specific Community legislation imposing minimum
requirements relating to the protection of human health or the
environment for the use of the substance, the risk is properly
controlled. In the establishment of such exemptions, account
shall be taken, in particular, of the proportionality of risk to
human health and the environment related to the nature of the
substance, such as where the risk is modified by the physical
form.

Prior to a decision to include substances in Annex XIV,
3.
the Agency shall,
the
taking into account
Member State Committee, recommend priority substances to
be included specifying for each substance the items set out in
paragraph 1. Priority shall normally be given to substances
with:

the opinion of

(a) PBT or vPvB properties; or

(b) wide dispersive use; or

(c) high volumes.

The number of substances included in Annex XIV and the dates
specified under paragraph 1 shall also take account of the
Agency's capacity to handle applications in the time provided
for. The Agency shall make its first recommendation of priority
substances to be included in Annex XIV by … (*). The Agency
shall make further recommendations at least every second year
with a view to including further substances in Annex XIV.

Before the Agency sends its recommendation to the
4.
Commission it shall make it publicly available on its website,
clearly indicating the date of publication, taking into account
Articles 117 and 118 on access to information. The Agency
shall invite all interested parties to submit comments within
three months of the date of publication, in particular on uses
which should be exempt from the authorisation requirement.

(i) the date(s) from which the placing on the market and
the use of the substance shall be prohibited unless an
authorisation is granted (hereinafter referred to as ‘the
sunset date’) which should take into account, where
appropriate, the production cycle specified for that use;

The Agency shall update its recommendation,
account the comments received.

taking into

(*) Two years after entry into force of this Regulation.

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5.
Subject to paragraph 6, after inclusion of a substance in
Annex XIV, this substance shall not be subjected to new restric-
tions under the procedure outlined in Title VIII covering the
risks to human health or the environment from the use of the
substance on its own, in a preparation or incorporation of a
substance in an article arising from the intrinsic properties
specified in Annex XIV.

6.
A substance listed in Annex XIV may be subjected to new
restrictions under the procedure outlined in Title VIII covering
the risks to human health or the environment from the use of
the substance in article(s).

7.
Substances for which all uses have been prohibited under
Title VIII or by other Community legislation shall not be
included in Annex XIV or shall be removed from it.

Substances which as a result of new information no
8.
longer meet the criteria of Article 56 shall be removed from
Annex XIV in accordance with the procedure referred to in
Article 132(3).

Article 58

Identification of substances referred to in Article 56

1.
The procedure set out in paragraphs 2 to 10 of this
Article shall apply for the purpose of identifying substances
meeting the criteria referred to in Article 56 and establishing a
candidate list for eventual inclusion in Annex XIV. The Agency
shall
indicate, within this list, the substances that are on its
work programme according to Article 82(3)(e).

2.
The Commission may ask the Agency to prepare a
dossier in accordance with relevant sections of Annex XV for
substances which in its opinion meet the criteria set out in
Article 56. The dossier may be limited,
if appropriate, to a
reference to an entry in Annex I of Directive 67/548/EEC. The
Agency shall make this dossier available to the Member States.

Any Member State may prepare a dossier in accordance
3.
with Annex XV for substances which in its opinion meet the
criteria set out in Article 56 and forward it to the Agency. The
dossier may be limited,
if appropriate, to a reference to an
entry in Annex I of Directive 67/548/EEC. The Agency shall
make this dossier available within 30 days of receipt to the
other Member States.

The Agency shall publish on its website a notice that an
4.
Annex XV dossier has been prepared for a substance. The
Agency shall invite all interested parties to submit comments
within a specified deadline to the Agency.

5. Within 60 days of circulation, the other Member States
or the Agency may comment on the identification of
the
substance in relation to the criteria in Article 56 in the dossier
to the Agency.

6.
If the Agency does not receive any comments, it shall
include this substance on the list referred to in paragraph 1.
The Agency may include this substance in its recommendations
under Article 57(3).

Upon receipt of comments from another Member State
7.
or other interested party or on its own initiative, the Agency
shall refer the dossier to the Member State Committee within
15 days of the end of the 60-day period referred to in para-
graph 5.

the referral,

If, within 30 days of

8.
the Member State
Committee reaches a unanimous agreement on the identifica-
tion, the Agency shall include the substance in the list referred
to in paragraph 1. The Agency may include that substance in
its recommendations under Article 57(3).

If the Member State Committee fails to reach a unani-
9.
mous agreement,
the Commission shall prepare a draft
proposal on the identification of the substance within three
the Member State
months of
Committee. A final decision on the identification of
the
substance shall be taken in accordance with the procedure
referred to in Article 132(3).

the opinion of

receipt of

10.
The Agency shall publish and update the list referred to
in paragraph 1 on its website without delay after a decision on
inclusion of a substance has been taken.

CHAPTER 2

Granting of authorisations

Article 59

Granting of authorisations

1.
The Commission shall be responsible for taking decisions
on applications for authorisations in accordance with this Title.

2. Without prejudice to paragraph 3, an authorisation shall
be granted if the risk to human health or the environment
from the use of a substance arising from the intrinsic properties
specified in Annex XIV is adequately controlled in accordance
with section 6.4 of Annex I and as documented in the appli-
cant's chemical safety report. The Commission shall take into
account all discharges, emissions and losses known at the time
of decision.

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The Commission shall not consider the risks to human health
arising from the use of a substance in a medical device regu-
lated by Council Directive 90/385/EEC of 20 June 1990 on the
approximation of the laws of the Member States relating to
active
medical
Council
Directive 93/42/EEC of 14 June 1993 concerning medical
devices (2) or Directive 98/79/EC of the European Parliament
and of the Council of 27 October 1998 on in vitro diagnostic
medical devices (3).

implantable

devices (1),

3.

Paragraph 2 shall not apply to:

(a) substances meeting the criteria in Article 56 (a), (b), (c) and
(f) for which it is not possible to determine a threshold in
accordance with section 6.4 of Annex I;

(b) substances meeting the criteria in Article 56 (d) and (e).

4.
If an authorisation cannot be granted under paragraph 2
or for substances listed in paragraph 3, an authorisation may
be granted if it is shown that socio-economic benefits outweigh
the risk to human health or the environment arising from the
use of the substance and if there are no suitable alternative
substances or technologies. This decision shall be taken after
consideration of all of the following elements:

(a) the risk posed by the uses of the substance;

(b) the socio-economic benefits arising from its use and the
socio-economic implications of a refusal to authorise as
demonstrated by the applicant or other interested parties;

(c) the analysis of the alternatives submitted by the applicant
under Article 61(4)(e) and any third party contributions
submitted under Article 63(2);

(d) available information on the risks to human health or the
environment of any alternative substances or technologies.

A use shall not be authorised if this would constitute a

5.
relaxation of a restriction set out in Annex XVII.

An authorisation shall be granted only if the application

6.
is made in conformity with the requirements of Article 61.

7. Where an application for authorisation includes the infor-
mation specified in Article 61(5)(b), this information shall be
the time-limited
considered in determining the duration of
review period in paragraph 8 of this Article.

8.
Authorisations shall be subject to a time-limited review
(whose duration shall be determined on a case-by-case basis)
without prejudice to any decision on a future review period
and shall normally be subject to conditions, including moni-
toring.

9.

The authorisation shall specify:

(1) OJ L 189, 20.7.1990, p. 17. Directive as last amended by Regu-

lation (EC) No 1882/2003.

(2) OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation

(EC) No 1882/2003.

(3) OJ L 331, 7.12.1998, p. 1. Directive as last amended by Regulation

(EC) No 1882/2003.

(a) the person(s) to whom the authorisation is granted;

(b) the identity of the substance(s);

(c) the use(s) for which the authorisation is granted;

(d) any conditions under which the authorisation is granted;

(e) the time-limited review period;

(f) any monitoring arrangement.

10.
Notwithstanding any conditions of an authorisation, the
holder shall ensure that the exposure is reduced to as low a
level as is technically and practically possible.

Article 60

Review of authorisations

Authorisations granted in accordance with Article 59
1.
shall be regarded as valid until the Commission decides to
amend or withdraw the authorisation in the context of a
review, provided that the holder of the authorisation submits a
review report at least 18 months before the expiry of the time-
limited review period. Rather than re-submitting all elements of
the original application for
the
holder of an authorisation may submit only the number of the
current authorisation, subject to the second, third and fourth
subparagraphs.

the current authorisation,

A holder of an authorisation granted in accordance with
Article 59 shall submit an update of any substitution plan
included in his application. If the holder cannot demonstrate
that the risk is adequately controlled, he shall submit an update
of
the socio-economic analysis, analysis of alternatives and
substitution plan contained in the original application.

If he can now demonstrate that
the risk is adequately
controlled, he shall submit an update of the chemical safety
report.

If any other elements of the original application have changed,
he shall also submit updates of these element(s).

2.

Authorisations may be reviewed at any time if:

(a) the

circumstances of

the original authorisation have
changed so as to affect the risk to human health or the
environment, or the socio-economic impact; or

(b) new information on possible substitutes becomes available.

The Commission shall set a reasonable deadline by which the
holder(s) of the authorisation may submit further information
necessary for the review and indicate by when it will take a
decision in accordance with Article 63.

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3.
In its review decision the Commission may, taking into
account the principle of proportionality, amend the authorisa-
tion or withdraw the authorisation from the time of the deci-
if under the changed circumstances it would not have
sion,
been granted.

In cases where there is a serious and immediate risk for human
health or the environment, the Commission may suspend the
authorisation pending the review, taking into account the prin-
ciple of proportionality.

4.
If an environmental quality standard referred to in
Directive 96/61/EC is not met, the authorisations granted for
the use of the substance concerned may be reviewed.

If

the

environmental objectives

5.
referred to in
Article 4(1) of Directive 2000/60/EC are not met, the authori-
sations granted for the use of the substance concerned in the
relevant river basin may be reviewed.

as

6.
If a use of a substance is subsequently prohibited or
otherwise restricted in Regulation (EC) No 850/2004 of the
European Parliament and of the Council of 29 April 2004 on
persistent
amending Directive
79/117/EEC (1), the Commission shall withdraw the authorisa-
tion for that use.

pollutants

organic

and

(e) an analysis of the alternatives considering their risks and

the technical and economic feasibility of substitution.

5.

The application may include:

(a) a socio-economic analysis conducted in accordance with

Annex XVI;

(b) where appropriate a substitution plan, including research
and development and a timetable for proposed actions by
the applicant;

(c) a justification for not considering risks to human health

and the environment arising either from:

(i) emissions of a substance from an installation for which
a permit was granted in accordance with Directive
96/61/EC; or

(ii) discharges of a substance from a point source governed
by the requirement for prior regulation referred to in
Article 11(3)(g) of Directive 2000/60/EC and legislation
adopted under Article 16 of that Directive.

6.
The application shall not include the risks to human
health arising from the use of a substance in a medical device
regulated by Directives 90/385/EEC, 93/42/EEC or 98/79/EC.

An application for an authorisation shall be accompanied

7.
by the fee required in accordance with Title IX.

Article 61

Applications for authorisations

Article 62

An application for an authorisation shall be made to the

1.
Agency.

Subsequent applications for authorisation

2.
Applications for authorisation may be made by the
manufacturer(s), importer(s) and/or downstream user(s) of the
substance. Applications may be made by one or several
persons.

3.
Applications may be made for one or several substances,
and for one or several uses. Applications may be made for the
applicant's own use(s) and/or for uses for which he intends to
place the substance on the market.

An application for

4.
following information:

authorisation shall

include

the

(a) the identity of the substance(s), as referred to in section 2

of Annex VI;

(b) the name and contact details of the person or persons

making the application;

(c) a request for authorisation, specifying for which use(s) the
authorisation is
the
substance in preparations and/or the incorporation of the
substance in articles, where this is relevant;

sought and covering the use of

(d) unless already submitted as part of

the registration, a
chemical safety report in accordance with Annex I covering
the risks to human health and/or the environment from the
use of the substance(s) arising from the intrinsic properties
specified in Annex XIV;

(1) OJ L 158, 30.4.2004, p. 7. Corrected in OJ L 229, 29.6.2004, p. 5.

1.
If an application has been made for a use of a substance,
a subsequent applicant may refer to the parts of the previous
application submitted in accordance with Article 61(4)(d)
and (5)(a) and (b), provided that the subsequent applicant has
permission from the previous applicant to refer to these parts
of the application.

2.
If an authorisation has been granted for a use of a
substance, a subsequent applicant may refer to the parts of the
with
submitted
holder's
Article 61(4)(d) and (5)(a) and (b), provided that the subsequent
applicant has permission from the holder of the authorisation
to refer to these parts of the application.

accordance

application

in

Article 63

Procedure for authorisation decisions

1.
The Agency shall acknowledge the date of receipt of the
application. The Agency's Committees for Risk Assessment and
Socio-economic Analysis shall give their draft opinions within
ten months of the date of receipt of the application.

2.
The Agency shall make available on its web-site broad
information on uses, taking into account Articles 117 and 118
on access to information, for which applications have been
received, with a deadline by which information on alternative
substances or technologies may be submitted by interested
third parties.

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3.
In preparing its opinion, each Committee referred to in
paragraph 1 shall first check that the application includes all
the information specified in Article 61 that is relevant to its
remit. If necessary, the Committees shall, in consultation with
each other, make a joint request to the applicant for additional
information to bring the application into conformity with the
requirements of Article 61. The Committee for Socio-economic
Analysis may, if it deems it necessary, require the applicant or
request third parties to submit, within a specified time period,
additional
information on possible alternative substances or
technologies. Each Committee shall also take into account any
information submitted by third parties.

4.

The draft opinions shall include the following elements:

(a) Committee for Risk Assessment: an assessment of the risk
to human health and/or the environment arising from the
use(s) of the substance as described in the application and,
if relevant, an assessment of the risks arising from possible
alternatives;

(b) Committee for Socio-economic Analysis: an assessment of
the socio-economic factors and the availability, suitability
and technical feasibility of alternatives associated with the
the substance as described in the application,
use(s) of
when an application is made
in accordance with
Article 61(5).

5.
The Agency shall send these draft opinions to the appli-
cant by the end of the deadline set out in paragraph 1. Within
one month of receipt of the draft opinion, the applicant may
provide written notice that he wishes to comment. The draft
opinion shall be deemed to have been received seven days after
the Agency has sent it.

If the applicant does not wish to comment, the Agency shall
send these opinions to the Commission, the Member States and
the applicant, within 15 days of the end of the period within
which the applicant may comment or within 15 days of receipt
of notice from the applicant
intend to
comment.

that he does not

6.
The Agency shall determine in accordance with Articles
117 and 118 which parts of its opinions and parts of any
attachments thereto should be made publicly available on its
website.

7.
In cases covered by Article 62(1), the Agency shall treat
the applications together, provided the deadlines for the first
application can be met.

8.
The Commission shall prepare a draft authorisation deci-
sion within three months of receipt of the opinions from the
Agency. A final decision granting or refusing the authorisation
shall be taken in accordance with the procedure referred to in
Article 132(2).

Summaries of the Commission decisions,

including the
9.
authorisation number, shall be published in the Official Journal
of the European Union and shall be made publicly available in
a database established and kept up to date by the Agency.

In cases covered by Article 62(2), the deadline set out in

10.
paragraph 1 of this Article shall be shortened to five months.

CHAPTER 3

Authorisations in the supply chain

Article 64

Obligation of holders of authorisations

Holders of an authorisation, as well as downstream users
referred to in Article 55(2)
including the substances in a
preparation, shall
include the authorisation number on the
label before they place the substance or a preparation
containing the substance on the market for an authorised use
without prejudice to Directive 67/548/EEC and Directive
1999/45/EC. This shall be done without delay once the authori-
sation number has been made publicly available in accordance
with Article 63(9).

Article 65

Downstream users

If the applicant wishes to comment, he shall send his written
argumentation to the Agency within two months of the receipt
of
the
the draft opinion. The Committees shall consider
comments and adopt their final opinions within two months of
receipt of the written argumentation, taking this argumentation
into account where appropriate. Within a further 15 days the
Agency shall send the opinions, with the written argumentation
attached, to the Commission, the Member States and the appli-
cant.

Downstream users using a substance in accordance with
1.
Article 55(2) shall notify the Agency within three months of
the first supply of the substance.

The Agency shall establish and keep up to date a register
2.
of downstream users who have made a notification in accord-
ance with paragraph 1. The Agency shall grant access to this
register to the competent authorities of the Member States.

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RESTRICTIONS ON THE MANUFACTURING, PLACING ON THE MARKET AND USE OF CERTAIN
DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES

TITLE VIII

CHAPTER 1

General issues

Article 66

General provisions

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 carcino-
genic, 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 132(3). Articles 68 to 72 shall not apply.

1.
A substance on its own, in a preparation or in an article,
for which Annex XVII contains a restriction shall not be manu-
factured, 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.

Paragraph 1 shall not apply to the use of substances in
2.
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 … (*), a Member State may maintain any existing
and more stringent restrictions in relation to Annex XVII on
the manufacture, placing on the market or use of a substance,
provided that those restrictions have been notified according to
the Treaty. The Commission shall compile and publish an
inventory of these restrictions by … (**).

CHAPTER 2

Restrictions process

Article 67

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 132(3) 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 68 to 72. Any
such decision shall
the socio-economic
take into account
impact of the restriction, including the availability of alterna-
tives.

(*) Six years after entry into force of this Regulation.
(**) Two years after entry into force of this Regulation.

Article 68

Preparation of a proposal

If

that

the Commission considers

1.
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.

After the date referred to in Article 57(1)(c)(i)

for a
2.
substance listed in Annex XIV,
the Agency shall consider
whether the use of that substance in articles poses a risk to
is not adequately
human health or the environment
the risk is not
controlled.
adequately controlled, it shall prepare a dossier which conforms
to the requirements of Annex XV.

the Agency considers

that

that

If

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 restric-
tions, 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 prepara-
tion or in an article poses a risk to human health or the envir-
onment 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 main-
tained by the Agency referred to in paragraph 5 of this Article,
the Member State shall prepare a dossier which conforms to
the requirements of Annex XV within 12 months of the notifi-
cation to the Agency. If this dossier demonstrates that action
on a Community-wide basis is necessary, beyond any measures
already in place,
to the
Agency in the format outlined in Annex XV, in order to initiate
the restrictions process.

the Member State shall submit

it

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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, estab-
lished under Community law and carrying out a similar task
shall provide information to the Agency or Member State
concerned on request.

shall check whether

The Committee for Risk Assessment and the Committee for
Socio-economic Analysis
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 Commit-
tees, otherwise the procedure under this Chapter shall be termi-
nated. 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 Member State
for the purposes of a proposed restriction. If a substance is on
the list, no other such dossier shall be prepared.
is
proposed by either a Member State or the Agency that an
existing restriction listed in Annex XVII should be re-examined
a decision on whether to do so shall be taken in accordance
with the procedure referred to in Article 132(2) based on
evidence presented by the Member State or the Agency.

If

it

6. Without prejudice to Articles 117 and 118, 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
interested parties to submit individually or jointly
invite all
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 69

Agency opinion: Committee for Risk Assessment

Within nine months of the date of publication referred to in
Article 68(6), the Committee for Risk Assessment shall formu-
late 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 point (a) of Article 68(6).

Article 70

Agency opinion: Committee for Socio-economic Analysis

1. Within 12 months of the date of publication referred to
in Article 68(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,
information
according to point (b) of Article 68(6), 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.

taking account of

analyses or

the

for

The Committee

Socio-economic Analysis

2.
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 point
(b) of Article 68(6) and under paragraph 1 of this Article.

3. Where the opinion of the Committee for Risk Assessment
diverges significantly from the restrictions suggested by a
Member State or the Commission, the Agency may postpone
the deadline for the opinion of
the Committee for Socio-
economic Analysis by a maximum of 90 days.

Article 71

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
for
on
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 69 and Article 70(1) the Agency shall
inform the Commission accordingly, stating the reasons.

restrictions

suggested

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2. Without prejudice to Articles 117 and 118 the Agency
shall publish the opinions of
the two Committees on its
website without delay.

for Socio-economic Analysis or by the end of the deadline
established under Article 70 if that Committee does not form
an opinion, whichever is the earlier.

The Agency shall provide

3.
the Commission and/or
Member State on request with all documents and evidence
submitted to or considered by it.

Article 72

Commission decision

1.
If the conditions laid down in Article 67 are fulfilled, the
Commission shall prepare a draft amendment to Annex XVII,
within three months of receipt of the opinion of the Committee

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 explana-
tion of the reasons for the differences.

2.
A final decision shall be taken in accordance with the
procedure referred to in Article 132(3). The Commission shall
send the draft amendment to the Member States at least 45 days
before voting.

TITLE IX

FEES AND CHARGES

Article 73

Fees and charges

1.
The fees that are required according to Article 6(4),
Article 7(1) and (5), Article 9(2), Article 11(4), Article 17(2),
Article 18(2), Article 19(3), Article 22(5), Article 61(7) and
Article 91(3) shall be specified in a Commission Regulation
adopted in accordance with the procedure referred to in Article
132(3) by … (*).

2.
A fee need not be paid for a registration of a substance in
a quantity of between 1 and 10 tonnes where the registration
dossier contains the full information in Annex VII.

3.
The structure and amount of the fees referred to in para-
graph 1 shall take account of the work required by this Regu-
lation to be carried out by the Agency and the competent
authority and shall be fixed at such a level as to ensure that the
revenue derived from them when combined with other sources
of the Agency's revenue pursuant to Article 95(1) is sufficient
to cover the cost of the services delivered. The fees set for regis-
tration shall take into account the work that may be done
pursuant to Title VI.

In the case of Article 6(4), Article 7(1) and (5), Article 9(2),
Article 11(4), Article 17(2) and Article 18(2), the structure and
amount of fees shall take account of the tonnage range of the
substance being registered.

In all cases, a reduced fee shall be set for SMEs.

In the case of Article 11(4), the structure and amount of fees
shall
information has been
submitted jointly or separately.

into account whether

take

In the case of a request made under Article 10(a)(xi), the struc-
ture and amount of fees shall take into account the work
required by the Agency in assessing the justification.

The Regulation referred to in paragraph 1 shall specify
4.
the circumstances under which a proportion of the fees will be
transferred to the relevant Member State competent authority.

The Agency may collect charges for other services it

5.
provides.

TITLE X

AGENCY

Article 74

Article 75

Establishment and review

Composition

1.
A European Chemicals Agency is established for the
purposes of managing and in some cases carrying out the tech-
nical, scientific and administrative aspects of REACH and to
in relation to these
ensure consistency at Community level
aspects.

1.

The Agency shall comprise:

2.

The Agency shall be subject to a review by … (**).

(*) One year after entry into force of this Regulation.
(**) Five years after entry into force of this Regulation.

(b) an Executive Director, who shall exercise the responsibil-

ities set out in Article 82;

(a) a Management Board, which shall exercise the responsibil-

ities set out in Article 77;

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(c) a Committee for Risk Assessment, which shall be respon-
sible for preparing the opinion of the Agency on evalua-
tions, applications for authorisation, proposals for restric-
tions and proposals for classification and labelling under
Title XI and any other questions that arise from the opera-
tion of this Regulation relating to risks to human health or
the environment;

(d) a Committee for Socio-economic Analysis, which shall be
responsible for preparing the opinion of the Agency on
applications for authorisation, proposals for restrictions,
and any other questions that arise from the operation of
this Regulation relating to the socio-economic impact of
possible legislative action on substances;

(e) a Member State Committee, which shall be responsible for
resolving potential divergences of opinions on draft deci-
sions proposed by the Agency or the Member States under
Title VI and proposals for identification of substances of
very high concern to be subjected to the authorisation
procedure under Title VII;

(f) a Forum for Exchange of

Information on Enforcement
(hereinafter referred to as ‘the Forum’) which shall coordi-
nate a network of Member States authorities responsible for
enforcement of this Regulation;

(g) a Secretariat, which shall work under the leadership of the
Executive Director and provide technical, scientific and
administrative support for the Committees and the Forum
and ensure appropriate coordination between them. It shall
also undertake the work required of the Agency under the
procedures for pre-registration, registration and evaluation
as well as preparation of guidance, database maintenance
and information provision;

(h) a Board of Appeal, which shall decide on appeals against

decisions taken by the Agency.

2.
The Committees referred to in points (c), (d) and (e) of
paragraph 1 (hereinafter referred to as ‘the Committees’) and
the Forum may each establish working groups. For
this
in accordance with their rules of
purpose they shall adopt,
procedure, precise arrangements for delegating certain tasks to
these working groups.

and technical advice on questions relating to chemicals which
fall within its remit and which are referred to it in accordance
with the provisions of this Regulation.

2.

The Secretariat shall undertake the following tasks:

(a) performing the tasks allotted to it under Title II; including
facilitating the efficient registration of imported substances,
in a way consistent with the Community's international
trading obligations towards third countries;

(b) performing the tasks allotted to it under Title III;

(c) performing the tasks allotted to it under Title VI;

It

shall make

(d) establishing and maintaining database(s) with information
on all registered substances, the classification and labelling
inventory and the harmonised classification and labelling
list.
in
Article 118(1) and (2) in the database(s) publicly available,
free of charge, over the Internet, except where a request
is considered justified. The
made under Article 10(a)(xi)
Agency shall make other information in the databases
available on request in accordance with Article 117;

information identified

the

(e) making publicly available

to which
substances are being, and have been evaluated within 90
days of receipt of
in
accordance with Article 118(1);

the information at

information as

the Agency,

(f) providing technical and scientific guidance and tools
where appropriate for the operation of this Regulation in
particular to assist the development of chemical safety
reports (in accordance with Article 14, Article 31(1) and
Article 36(4)) and application of Article 10(a)(viii), Article
11(3) and Article 19(2) by industry and especially by
SMEs;

(g) providing technical and scientific guidance on the opera-
tion of this Regulation for Member State competent autho-
rities and providing support to the helpdesks established
by Member States under Title XIII;

3.
The Committees and the Forum may, if they consider it
appropriate, seek advice on important questions of a general
scientific or ethical nature from appropriate sources of exper-
tise.

(h) providing advice and assistance to manufacturers and
registering a substance in accordance with

importers
Article 12(1);

Article 76

Tasks

1.
The Agency shall provide the Member States and the
institutions of the Community with the best possible scientific

(i) preparing explanatory information on this Regulation for

other stakeholders;

(j) at the Commission's request, providing technical and scien-
tific support for steps to improve cooperation between the
Community, its Member States, international organisations
and third countries on scientific and technical
issues
relating to the safety of substances, as well as active partici-
pation in technical assistance and capacity building activ-
ities on sound management of chemicals in developing
countries;

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(k) keeping a Manual of Decisions and Opinions based on
conclusions from the Member State Committee regarding
interpretation and implementation of this Regulation;

(l) notification of decisions taken by the Agency;

(m) provision of formats for submission of information to the

Agency.

3.

The Committees shall undertake the following tasks:

(a) performing the tasks allotted to them under Titles VI to XI;

(b) at the Commission's request, providing technical and scien-
tific support for steps to improve cooperation between the
Community, its Member States, international organisations
and third countries on scientific and technical
issues
relating to the safety of substances, as well as active partici-
pation in technical assistance and capacity building activ-
ities on sound management of chemicals in developing
countries;

(c) at the Commission's request, drawing up an opinion on
any other aspects concerning the safety of substances on
their own, in preparations or in articles.

4.

The Forum shall undertake the following tasks:

(a) spreading good practice and highlighting problems at Com-

munity level;

(b) by 31 October each year the work programme of the
Agency for the coming year and forward it to the Member
States,
the Council and the
Commission;

the European Parliament,

(c) the final budget of the Agency pursuant to Article 95
before the beginning of the financial year, adjusting it,
where necessary, according to the Community contribution
and any other revenue of the Agency;

(d) a multi-annual work programme, which shall be regularly

revised.

It shall adopt the internal rules and procedures of the Agency.
These rules shall be made public.

It shall perform its duties in relation to the Agency's budget
pursuant to Articles 95, 96 and 102.

shall exercise disciplinary authority over

It
Director.

the Executive

It shall adopt its rules of procedure.

It shall appoint the Chairman, the members and alternates of
the Board of Appeal in accordance with Article 88.

(b) proposing, coordinating and evaluating harmonised enfor-

cement projects and joint inspections;

It shall appoint the members of the Agency committees as set
out in Article 84.

(c) coordinating exchange of inspectors;

(d) identifying enforcement strategies, as well as best practice

in enforcement;

(e) developing working methods and tools of use to local

inspectors;

(f) developing an electronic information exchange procedure;

(g) liaising with industry and other stakeholders, including rele-

vant international organisations, as necessary;

(h) examining proposals for restrictions with a view to advising

on enforceability.

It shall
outcome of
Article 95(6).

forward annually any information relevant

to the
the evaluation procedures in accordance with

Article 78

Composition of the Management Board

1.
The Management Board shall be composed of one repre-
sentative from each Member State and a maximum of six repre-
sentatives appointed by the Commission, including three indivi-
duals from interested parties without voting rights.

Article 77

Powers of the Management Board

Each Member State shall nominate a member to the Manage-
ment Board. The members thus nominated shall be appointed
by the Council.

The Management Board shall appoint the Executive Director
pursuant to Article 83 and an accounting officer in accordance
with Article 43 of Regulation (EC, Euratom) No 2343/2002.

It shall adopt:

2. Members shall be appointed on the basis of their relevant
experience and expertise in the field of chemical safety or the
regulation of chemicals whilst ensuring there is relevant exper-
tise amongst the board members in the fields of general, finan-
cial and legal matters.

(a) by 30 April each year, the general report of the Agency for
the previous year and forward it by 15 June at the latest to
the Member States, the European Parliament, the Council,
the Commission,
the European Economic and Social
Committee and the Court of Auditors;

3.
The duration of the term of office shall be four years. The
term of office may be renewed once. However, for the first
mandate, the Commission shall identify half of its appointees,
and the Council shall identify 12 of its appointees, for whom
this period shall be six years.

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Article 79

Chairmanship of the Management Board

(f) the preparation of the statement of revenue and expendi-
ture and the implementation of the budget of the Agency
pursuant to Articles 95 and 96;

1.
The Management Board shall elect a Chairman and a
Deputy-Chairman from among the members with voting
rights. The Deputy-Chairman shall automatically take the place
of the Chairman if he is prevented from attending to his duties.

2.
The terms of office of the Chairman and the Deputy-
Chairman shall be two years and shall expire when they cease
to be members of the Management Board. The term of office
shall be renewable once.

Article 80

Meetings of the Management Board

The meetings of

1.
the Management Board shall be
convened by invitation of its Chairman or at the request of at
least one third of the Board members.

The Executive Director shall take part in the meetings of

2.
the Management Board, without voting rights.

3.
The Chairmen of the Committees and the Chairman of
the Forum, as referred to in Article 75(1)(c) to (f), are entitled
to attend the meetings of
the Management Board without
voting rights.

(g) all staff matters;

(h) providing the secretariat for the Management Board;

(i) preparing draft opinions of

the Management Board
concerning the proposed rules of procedure of the Commit-
tees and of the Forum;

(j) making arrangements, upon request from the Management
Board, for the execution of any further function(s) (within
the remit of Article 76) allotted to the Agency by delega-
tion from the Commission;

(k) determining the terms and conditions for use of software

packages.

Each year,

3.
shall
following to the Management Board for approval:

the Executive Director

submit

the

(a) a draft report covering the activities of the Agency in the
previous year, including information about the number of
registration dossiers received,
the number of substances
the number of applications for authorisation
evaluated,
received, the number of proposals for restriction received
the time taken for
by the Agency and opined upon,
and
the
completion of
the
substances
substances
authorised,
restricted; complaints received and the action taken; an
overview of the activities of the Forum;

associated procedures,

rejected,

dossiers

Article 81

(b) a draft work-programme for the coming year;

Voting of the Management Board

(c) the draft annual accounts;

The Management Board shall adopt rules of procedure for
voting,
including the conditions for a member to vote on
behalf of another member. The Management Board shall act by
a two-thirds majority of all members with the right to vote.

(d) the draft forecast budget for the coming year;

(e) a draft multi-annual work programme.

Article 82

Article 83

Duties and powers of the Executive Director

Appointment of the Executive Director

1.
The Agency shall be managed by its Executive Director,
who shall perform his duties in the interests of the Community,
and independently of any specific interests.

The Executive Director shall be the legal representative of

2.
the Agency. He shall be responsible for:

(a) the day-to-day administration of the Agency;

(b) managing all the Agency resources necessary for carrying

out its tasks;

(c) ensuring that

the time-limits laid down in Community
legislation for the adoption of opinions by the Agency are
complied with;

(d) ensuring appropriate and timely coordination between the

Committees and the Forum;

(e) concluding and managing necessary contracts with service

providers;

1.
The Commission shall propose candidates for the post of
the Executive Director based on a list following publication of
the post in the Official Journal of the European Union and
other press or Internet sites as appropriate.

2.
The Executive Director of the Agency shall be appointed
by the Management Board on the grounds of merit and docu-
mented administrative and management skills, as well as his
relevant experience in the fields of chemical safety or regu-
lation. The Management Board shall take its decision by a two-
thirds majority of all members with a right to vote.

Power to dismiss the Executive Director shall
Management Board, in accordance with the same procedure.

lie with the

3.
The term of the office of the Executive Director shall be
five 5 years. It may be prolonged by the Management Board
once for another period of up to five years.

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Article 84

authority shall facilitate the activities of the Committees and
their working groups.

Establishment of the Committees

1.
Each Member State may nominate candidates to member-
ship of the Committee for Risk Assessment. The Executive
Director shall establish a list of the nominees, which shall be
published on the Agency's website. The Management Board
shall appoint the members of the Committee from this list,
including at least one member but not more than two from the
nominees of each Member State that has nominated candidates.
Members shall be appointed for their role and experience in
performing the tasks specified in Article 76(3).

Each Member State may nominate candidates to member-
2.
ship of
the Committee for Socio-economic Analysis. The
Executive Director shall establish a list of the nominees, which
shall be published on the Agency's website. The Management
Board shall appoint the members of the Committee from this
including at least one member but not more than two
list,
from the nominees of each Member State that has nominated
candidates. Members shall be appointed for their role and
experience in performing the tasks specified in Article 76(3).

Each Member State shall appoint one member to the

3.
Member State Committee.

The Committees shall aim to have a broad range of rele-
4.
vant expertise among their members. To this end each
Committee may co-opt a maximum of five additional members
chosen on the basis of their specific competence.

Members of the Committees shall be appointed for a term of
three years which shall be renewable.

The members of the Management Board may not be members
of the Committees.

The members of each Committee may be accompanied by advi-
sers on scientific, technical or regulatory matters.

The Executive Director or his representative and representatives
of the Commission shall be entitled to attend all the meetings
the Committees and working groups convened by the
of
Agency or its committees as observers. Stakeholders may also
be invited to attend meetings as observers, as appropriate, at
the request of the Committee members, or the Management
Board.

5.
The members of each Committee appointed following
nomination by a Member State shall ensure that there is appro-
priate coordination between the tasks of the Agency and the
work of their Member State competent authority.

7.
The Member States shall refrain from giving the members
of the Committee for Risk Assessment or of the Committee for
Socio-Economic Analysis, or their scientific and technical advi-
sers and experts, any instruction which is incompatible with
the individual tasks of those persons or with the tasks, respon-
sibilities and independence of the Agency.

8. When preparing an opinion, each Committee shall use its
best endeavours to reach a consensus. If such a consensus
cannot be reached, the opinion shall consist of the position of
the majority of members and the minority position(s), with
their grounds.

Each Committee shall draft a proposal for its own rules
to be approved by the Management Board,

9.
of procedure,
within six months of the Committees first being appointed.

These rules shall
in particular lay down the procedures for
replacing members, the procedures for delegating certain tasks
to working groups, the creation of working groups and the
the urgent adoption of
establishment of a procedure for
opinions. The Chairman of each Committee shall be an
employee of the Agency.

Article 85

Establishment of the Forum

1.
Each Member State shall appoint, for a three-year term,
which shall be renewable, one member to the Forum. Members
shall be chosen for their role and experience in enforcement of
chemicals legislation and shall maintain relevant contacts with
the Member State competent authorities.

The Forum shall aim to have a broad range of relevant exper-
tise among its members. To this end the Forum may coopt a
maximum of five additional members chosen on the basis of
their specific competence. These members shall be appointed
for a term of three years, which shall be renewable.

The members of the Forum may be accompanied by scientific
and technical advisers.

The Executive Director of the Agency or his representative and
representatives of the Commission shall be entitled to attend all
the meetings of the Forum and its working groups. Stake-
holders may also be invited to attend meetings as observers, as
appropriate, at the request of Forum members, or the Manage-
ment Board.

6.
The members of the Committees shall be supported by
the scientific and technical resources available to the Member
States. To this end, Member States shall provide adequate scien-
tific and technical resources to the members of the Committees
they have nominated. Each Member State competent
that

The members of the Forum appointed by a Member State
2.
shall ensure that there is appropriate coordination between the
tasks of the Forum and the work of their Member State compe-
tent authority.

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3.
The members of the Forum shall be supported by the
scientific and technical resources available to the competent
authorities of the Member States. Each Member State compe-
tent authority shall facilitate the activities of the Forum and its
working groups. The Member States shall refrain from giving
the Forum members, or their scientific and technical advisers
and experts any instruction which is incompatible with the
individual tasks of those persons or with the tasks and respon-
sibilities of the Forum.

4.
The Forum shall draft a proposal for its own rules of
procedure, to be adopted by the Management Board, within six
months of the Forum first being appointed.

in particular lay down the procedures for
These rules shall
appointing and replacing the Chairman, replacing members
and the procedures for delegating certain tasks to working
groups.

Forum, or performing any other task for the Agency shall be
governed by a written contract between the Agency and the
person concerned, or where appropriate between the Agency
and the employer of the person concerned.

The person concerned, or his employer, shall be remunerated
by the Agency in accordance with a scale of fees to be included
in the financial arrangements established by the Management
Board. Where the person concerned fails to fulfil his duties, the
Executive Director has the right to terminate or suspend the
contract or withhold remuneration.

4.
The provision of services for which there are several
potential providers may require a call for an expression of
interest:

(a) if the scientific and technical context allows; and

(b) if it is compatible with the duties of the Agency, in particu-
lar the need to provide a high level of protection of human
health and the environment.

Article 86

The Management Board shall adopt the appropriate procedures
on a proposal from the Executive Director.

Rapporteurs of Committees and use of experts

The Agency may use the services of experts for the

5.
discharge of other specific tasks for which it is responsible.

1. Where,
in accordance with Article 76, a Committee is
required to take a decision, provide an opinion or consider
whether a Member State dossier conforms with the require-
ments of Annex XV, it shall appoint one of its members as a
rapporteur. The Committee concerned may appoint a second
member to act as co-rapporteur. For each case, rapporteurs and
co-rapporteurs shall undertake to act in the interests of the
Community and shall make a declaration of commitment to
fulfil
interests in writing.
A member of a Committee shall not be appointed rapporteur
for a particular case if he indicates any interest that might be
prejudicial to the independent consideration of that case. The
Committee concerned may replace the rapporteur or co-
rapporteur by another one of its members at any time, if, for
their duties within the
example,
prescribed time limits, or if a potentially prejudicial
interest
comes to light.

their duties and a declaration of

they are unable to fulfil

Article 87

Qualification and interests

1.
The membership of the Committees and of the Forum
shall be made public. Individual members may request that
their names not be made public if they believe that such publi-
cation could place them at risk. The Executive Director shall
decide whether to agree to such requests. When each appoint-
ment
the professional qualifications of each
is published,
member shall be specified.

2. Member States shall transmit to the Agency the names of
experts with proven experience in the tasks required by Article
76, who would be available to serve on working groups of the
Committees, together with an indication of their qualifications
and specific areas of expertise.

the Management Board,

2. Members of
the Executive
Director and members of the Committees and of the Forum
shall make a declaration of commitment to fulfil their duties
and a declaration of interests which could be considered to be
prejudicial to their independence. These declarations shall be
made annually in writing.

The Agency shall keep an up-to-date list of experts. The list
shall include the experts referred to in the first subparagraph
and other experts identified directly by the Secretariat.

3.
expert serving on a working group of

The provision of services by Committee members or any
the Committees or

3.
At each of their meetings, members of the Management
Board, the Executive Director, members of the Committees and
of the Forum and any experts participating in the meeting shall
declare any interests which could be considered to be prejudi-
cial to their independence with respect to any points on the
agenda. Anyone declaring such interests shall not participate in
any voting on the relevant agenda point.

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Article 88

Establishment of the Board of Appeal

The Board of Appeal shall consist of a Chairman and two

1.
other members.

The Chairman and the two members shall have alternates

2.
who shall represent them in their absence.

3.
The Chairman, the other members and the alternates shall
be appointed by the Management Board on the basis of their
relevant experience and expertise in the field of chemical safety,
natural sciences or regulatory and judicial procedures from a
list of qualified candidates adopted by the Commission.

The Management Board may appoint additional members and
their alternates, on recommendation by the Executive Director,
following the same procedure, if this is necessary to ensure that
the appeals can be processed at a satisfactory rate.

4.
The qualifications required for the members of the Board
of Appeal shall be determined by the Commission in accord-
ance with the procedure referred to in Article 132(3).

The Chairman and the members shall have equal voting

5.
rights.

6.
If a member of the Board of Appeal considers for reasons
mentioned in paragraph 5 that he must not take part in any
appeal proceedings, he shall
inform the Board of Appeal
accordingly. Members of the Board may be objected to by any
party to the appeal proceedings on any of
the grounds
mentioned in paragraph 5, or if suspected of partiality. No
objection may be based on the nationality of members.

7.
The Board of Appeal shall decide as to the action to be
taken in the cases specified in paragraphs 5 and 6 without the
participation of the member concerned. For the purposes of
taking this decision, the member concerned shall be replaced
on the Board of Appeal by an alternate.

Article 90

Decisions subject to appeal

1.
the
An appeal may be brought against decisions of
Agency taken pursuant to Article 9, Article 20, Article 27(6),
Article 30(2) and (3) and Article 50.

2.
An appeal
suspensive effect.

lodged pursuant to paragraph 1 shall have

Article 89

Persons entitled to appeal, time-limits, fees and form

Article 91

Members of the Board of Appeal

The term of office of

1.
Appeal,
five years. It may be prolonged once.

the Board of
including the Chairman and the alternates shall be

the members of

2.
The members of the Board of Appeal shall be indepen-
dent. In making their decisions they shall not be bound by any
instructions.

1.
Any natural or legal person may appeal against a decision
addressed to that person, or against a decision which, although
addressed to another person, is of direct and individual concern
to the former.

2.
The appeal, together with the statements of the grounds
thereof, shall be filed in writing to the Agency within three
months of
the decision to the person
concerned, or in the absence thereof, of the day on which it
became known to the latter, unless otherwise provided in this
Regulation.

the notification of

3.
The members of the Board of Appeal may not perform
any other duties in the Agency. The function of the members
may be a part-time function.

A fee may be payable by persons bringing an appeal

3.
against an Agency decision, in accordance with Title IX.

The members of

4.
the Board of Appeal may not be
removed either from office or from the list during their respec-
tive terms, unless there are serious grounds for such removal
the
and the Commission, after obtaining the opinion of
Management Board, takes a decision to this effect.

Article 92

Examination and decisions on appeal

5. Members of the Board of Appeal may not take part in
interest
any appeal proceedings if
therein, or if they have previously been involved as representa-
tives of one of the parties to the proceedings, or if they partici-
pated in the decision under appeal.

they have any personal

If, after consultation with the Chairman of the Board of
1.
to be
the Executive Director considers the appeal
Appeal,
admissible and well founded he may rectify the decision within
30 days of the appeal being filed in accordance with Article
91(2).

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the Chairman of

In cases other than those referred to in paragraph 1 of
2.
this Article,
the Board of Appeal shall
examine whether the appeal is admissible within 30 days of the
appeal being filed in accordance with Article 91(2). In the affir-
mative, the appeal shall be remitted to the Board of Appeal for
examination of the grounds. Parties to the appeal proceedings
shall be entitled to make an oral presentation during the proce-
dure.

3.
The Board of Appeal may exercise any power which lies
within the competence of the Agency or remit the case to the
competent body of the Agency for further action.

4.
The procedures for the Board of Appeal shall be deter-
mined by the Commission in accordance with the procedure
referred to in Article 132(3).

Article 93

Actions before the Court of First Instance and the Court
of Justice

An action may be brought before the Court of First
1.
Instance or the Court of Justice, in accordance with Articles 225
or 230 of the Treaty, contesting a decision taken by the Board
of Appeal or, in cases where no right of appeal lies before the
Board, by the Agency.

2.
Should the Agency fail to take a decision, proceedings for
failure to act may be brought before the Court of First Instance
or the Court of Justice in accordance with Articles 225 or 232
of the Treaty.

3.
The Agency shall be required to take the necessary
measures to comply with the judgment of the Court of First
Instance or the Court of Justice.

Article 94

Conflicts of opinion with other bodies

1.
The Agency shall take care to ensure early identification
of potential sources of conflict between its opinions and those
of other bodies established under Community law,
including
Community Agencies, carrying out a similar task in relation to
issues of common concern.

2. Where the Agency identifies a potential source of conflict,
it shall contact the body concerned in order to ensure that any
relevant scientific or technical
information is shared and to
identify the scientific or technical points which are potentially
contentious.

3. Where there is a fundamental conflict over scientific or
technical points and the body concerned is a Community
Agency or a scientific committee, the Agency and the body
concerned shall work together either to solve the conflict or to
submit a joint document to the Commission clarifying the
scientific and/or technical points of conflict.

Article 95

The budget of the Agency

1.

The revenues of the Agency shall consist of:

(a) a subsidy from the Community, entered in the general
(Commission

European Communities

the

budget of
Section);

(b) the fees paid by undertakings;

(c) any voluntary contribution from the Member States.

The expenditure of the Agency shall

2.
administrative, infrastructure and operational expenses.

include the staff,

3.
By 15 February of each year at the latest, the Executive
Director shall draw up a preliminary draft budget covering the
operational expenditure and the programme of work antici-
pated for the following financial year, and shall forward this
preliminary draft to the Management Board together with an
establishment plan accompanied by a provisional list of posts.

4.

Revenue and expenditure shall be in balance.

Each year the Management Board, on the basis of a draft
5.
drawn up by the Executive Director, shall produce an estimate
of revenue and expenditure for the Agency for the following
financial year. This estimate, which shall include a draft estab-
lishment plan, shall be forwarded by the Management Board to
the Commission by 31 March at the latest.

6.
The estimate shall be forwarded by the Commission to
the European Parliament and the Council (hereinafter referred
to as ‘the budgetary authority’) together with the preliminary
draft budget of the European Communities.

7.
On the basis of the estimate, the Commission shall enter
in the preliminary draft budget of the European Communities
the estimates it considers necessary for the establishment plan
and the amount of the subsidy to be charged to the general
budget, which it shall place before the budgetary authority in
accordance with Article 272 of the Treaty.

The budgetary authority shall authorise the appropria-

8.
tions for the subsidy to the Agency.

The budgetary authority shall adopt the establishment plan for
the Agency.

The budget of

9.
the Agency shall be adopted by the
Management Board. It shall become final following final adop-
tion of
the European Communities.
Where appropriate, it shall be adjusted accordingly.

the general budget of

Any modification to the budget, including the establish-

10.
ment plan, shall follow the procedure referred to above.

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11.
The Management Board shall, without delay, notify the
budgetary authority of its intention to implement any project
which may have significant
the
in particular any projects relating to
funding of its budget,
property such as the rental or purchase of buildings. It shall
inform the Commission thereof.

implications for

financial

By 1 July of the following year at the latest, the Executive
7.
Director shall send the final accounts,
together with the
opinion of the Management Board, to the European Parliament,
the Council, the Commission and the Court of Auditors.

8.

The final accounts shall be published.

Where a branch of the budgetary authority has notified its
intention to deliver an opinion, it shall forward its opinion to
the Management Board within a period of six weeks from the
date of notification of the project.

9.
The Executive Director shall send the Court of Auditors a
reply to its observations by 30 September at the latest. He shall
also send this reply to the Management Board.

Article 96

Implementation of the budget of the Agency

The Executive Director shall perform the duties of author-

1.
ising officer and shall implement the Agency's budget.

2. Monitoring of the commitment and payment of all the
Agency's expenditure and of the establishment and recovery of
all the Agency's revenue shall be carried out by the Accounting
Officer of the Agency.

3.
By 1 March at the latest following each financial year, the
Agency's accounting officer shall communicate the provisional
accounts to the Commission's accounting officer together with
a report on the budgetary and financial management for that
financial year. The Commission's accounting officer
shall
consolidate the provisional accounts of the institutions and
decentralised bodies
in accordance with Article 128 of
Regulation (EC, Euratom) No 1605/2002 of 25 June 2002 on
the Financial Regulation applicable to the general budget of the
European Communities (1).

4.
By 31 March at the latest following each financial year,
the Commission's accounting officer shall forward the Agency's
provisional accounts to the Court of Auditors, together with a
report on the budgetary and financial management for that
financial year. The report on the budgetary and financial
management for that financial year shall also be forwarded to
the European Parliament and the Council.

On receipt of the Court of Auditors' observations on the
5.
to Article 129 of
Agency's provisional accounts, pursuant
Regulation (EC, Euratom) No 1605/2002,
the Executive
Director shall draw up the Agency's final accounts under his
own responsibility and forward them to the Management
Board for an opinion.

The Management Board shall deliver an opinion on the

6.
Agency's final accounts.

10.
The European Parliament, upon a recommendation from
the Council, shall, before 30 April of year N + 2, give a
discharge to the Executive Director in respect of the implemen-
tation of the budget for year N.

Article 97

Combating fraud

1.
In order to combat fraud, corruption and other unlawful
activities, the provisions of Regulation (EC) No 1073/1999 of
the European Parliament and of the Council of 25 May 1999
concerning investigations conducted by the European Anti-
Fraud Office (OLAF) (2) shall apply without restrictions to the
Agency.

The Agency shall be bound by the Interinstitutional
2.
Agreement of 25 May 1999 between the European Parliament,
the Council of the European Union and the Commission of the
investigations by
European Communities concerning internal
the European Anti-Fraud Office (OLAF) (3) and shall
issue,
without delay, the appropriate provisions applicable to all of its
staff.

The decisions concerning funding and the implementing
3.
agreements and instruments resulting from them shall explicitly
stipulate that the Court of Auditors and OLAF may carry out, if
necessary, on-the-spot checks of the recipients of the Agency's
funding and the agents responsible for allocating it.

Article 98

Financial rules

The financial rules applicable to the Agency shall be adopted
by the Management Board after the Commission has been
consulted. They may not depart from Regulation (EC, Euratom)
No 2343/2002 unless specifically necessary for the Agency's
operation and with the Commission's prior consent.

(1) OJ L 248, 16.9.2002, p. 1.

(2) OJ L 136, 31.5.1999, p. 1.
(3) OJ L 136, 31.5.1999, p. 15.

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Article 99

Legal personality of the Agency

1.
The Agency shall be a body of the Community and shall
have legal personality. In each Member State it shall enjoy the
most extensive legal capacity accorded to legal persons under
their laws. In particular it may acquire and dispose of movable
and immovable property and may be a party to legal proceed-
ings.

The Agency shall be

2.
Director.

represented by its Executive

Article 100

Liability of the Agency

3.
The Agency's staff shall consist of officials assigned or
seconded by the Commission or Member States on a temporary
basis and of other servants recruited by the Agency as neces-
its
sary to carry out
personnel on the basis of a staffing plan to be included in the
multi-annual work programme referred to in Article 77(d).

its tasks. The Agency shall

recruit

Article 103

Languages

1.
Regulation No 1 of 15 April 1958 determining the
languages to be used in the European Economic Community (1)
shall apply to the Agency.

2.
The translation services required for the functioning of
the Agency shall be provided by the Translation Centre of the
bodies of the European Union.

1.
The contractual liability of the Agency shall be governed
by the law applicable to the contract in question. The Court of
Justice shall have jurisdiction pursuant to any arbitration clause
contained in a contract concluded by the Agency.

Article 104

Duty of confidentiality

2.
In the case of non-contractual liability, the Agency shall,
in accordance with the general principles common to the laws
of the Member States, make good any damage caused by it or
by its servants in the performance of their duties.

Members of the Management Board, members of the Commit-
tees and of the Forum, experts and officials and other servants
of the Agency, shall be required, even after their duties have
ceased, not to disclose information of the kind covered by the
duty of professional secrecy.

The Court of
relating to compensation for such damages.

Justice shall have jurisdiction in any dispute

The personal

3.
its
servants towards the Agency shall be governed by the relevant
rules applying to the staff of the Agency.

financial and disciplinary liability of

Article 105

Participation of third countries

The Management Board may, in agreement with the relevant
Committee or the Forum, invite representatives of third coun-
tries to participate in the work of the Agency.

Article 101

Privileges and immunities of the Agency

Article 106

The Protocol on the Privileges and Immunities of the European
Communities shall apply to the Agency.

Article 102

Staff rules and regulations

The staff of the Agency shall be subject to the Regulations
1.
and Rules applicable to officials and other servants of the Euro-
pean Communities. In respect of its staff, the Agency shall exer-
cise the powers which have been devolved to the appointing
authority.

The Management Board shall,

2.
Commission, adopt the necessary implementing provisions.

in agreement with the

Participation of international organisations

The Management Board may, in agreement with the relevant
Committee or the Forum, invite representatives of international
organisations with interests in the field of chemicals regulation
to participate as observers in the work of the Agency.

Article 107

Contacts with stakeholder organisations

The Management Board shall, in agreement with the Commis-
sion, develop appropriate contacts between the Agency and
relevant stakeholder organisations.

(1) OJ 17, 6.10.1958, p. 385. Regulation as last amended by Council

Regulation (EC) No 920/2005 (OJ L 156, 18.6.2005, p. 3).

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Article 108

Rules on transparency

To ensure transparency, the Management Board shall, on the
basis of a proposal by the Executive Director and in agreement
with the Commission, adopt rules to ensure the availability to
the public of regulatory, scientific or technical
information
concerning the safety of substances on their own, in prepara-
tions or in articles which is not of a confidential nature.

Article 109

Relations with relevant Community bodies

1.
The Agency shall cooperate with other Community
bodies to ensure mutual support in the accomplishment of
their respective tasks in particular to avoid duplication of work.

The Executive Director, having consulted the Committee
2.
on Risk Assessment and the European Food Safety Authority,
shall establish rules of procedure concerning substances for
which an opinion has been sought in a food safety context.
These rules of procedure shall be adopted by the Management
Board, in agreement with the Commission.

This Title shall not otherwise affect the competences vested in
the European Food Safety Authority.

This Title shall not affect the competences vested in the

3.
European Medicines Agency.

4.
on Risk Assessment,

The Executive Director, having consulted the Committee
the Committee on Socio-economic

Analysis and the Advisory Committee on Safety, Hygiene and
Health Protection at Work, shall establish rules of procedure
concerning worker protection issues. These rules of procedure
shall be adopted by the Management Board, in agreement with
the Commission.

This Title shall not affect the competences vested in the Advi-
sory Committee on Safety, Hygiene and Health Protection at
Work and the European Agency for Health and Safety at Work.

Article 110

Formats and software for submission of information to
the Agency

The Agency shall specify formats and make them available free
of charge, and software packages and make them available on
its website for any submissions to the Agency. Member States,
manufactures, importers, distributors or downstream users shall
use these formats and packages in their submissions to the
Agency pursuant to this Regulation. In particular, the Agency
shall make available software tools to facilitate the submission
of all information relating to substances registered in accord-
ance with Article 12(1).

For the purposes of registration, the format of the technical
dossier referred to in Article 10(a) shall be IUCLID. The Agency
shall coordinate the further development of this format with
the Organisation for Economic Cooperation and Development
to ensure maximum harmonisation.

TITLE XI

CLASSIFICATION AND LABELLING INVENTORY

Article 111

Scope

This Title shall apply to:

(a) substances subject

to registration by a manufacturer or

importer;

(b) substances within

the

scope

of Article

of
Directive 67/548/EEC, which meet the criteria for classifica-
tion as dangerous in accordance with that Directive, and
which are placed on the market either on their own, or in
a preparation above the concentration limits specified in
Directive 1999/45/EC, where relevant, which results in the
classification of the preparation as dangerous.

1

inventory in accordance with Article 113, unless submitted as
part of the registration:

(a) the identity of the manufacturer or importer responsible for
placing the substance(s) on the market as specified in
section 1 of Annex VI;

(b) the identity of the substance(s) as specified in sections 2.1

to 2.3.4 of Annex VI;

(c) the hazard classification of the substance(s), resulting from
the application of Articles 4 and 6 of Directive 67/548/EEC;

(d) the hazard label for the substance(s), resulting from the
application of Article 23 (c) to (f), of Directive 67/548/EEC;

Article 112

Obligation to notify the Agency

(e) specific concentration limits, where applicable, resulting
from the application of Article 4(4) of Directive 67/548/EEC
and Articles 4 to 7 of Directive 1999/45/EC.

Any manufacturer or importer, or group of manufac-
1.
turers or importers, who place on the market a substance
within the scope of Article 111, shall notify to the Agency the
following information in order for it to be included in the

in
2. Where the obligation under paragraph 1 results
different entries on the inventory for the same substance, the
notifiers and registrants shall make every effort to come to an
agreed entry to be included in the inventory.

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The information listed in paragraph 1 shall be updated by

3.
the notifier(s) whenever:

(a) any new scientific or technical

information is generated
which results in a change to the classification and labelling
of the substance;

(b) notifiers and registrants of differing entries for a single
substance come to an agreed entry in accordance with
paragraph 2.

Article 113

Classification and labelling inventory

1.
A classification and labelling inventory, listing the infor-
mation referred to in Article 112(1), both for information noti-
fied under Article 112(1) as well as for information submitted
as part of a registration, shall be established and maintained by
the Agency in the form of a database. The information in this
database identified in Article 118(1) shall be publicly accessible.
The Agency shall grant access to the other data on each
substance in the inventory to the notifiers and registrants who
have submitted information on that substance in accordance
with Article 29(1).

The Agency shall update the inventory when it
updated information in accordance with Article 112(3).

receives

In addition to the information referred to in paragraph 1,
2.
the Agency shall record the following information, where
appropriate, against each entry:

(a) whether, in respect of the entry, there is a harmonised clas-
sification and labelling at Community level by inclusion in
Annex I of Directive 67/548/EEC;

(b) whether, in respect of the entry, it is a joint entry between
registrants of the same substance as per Article 11(1);

(c) if the entry differs from another entry on the inventory for

the same substance;

(d) the relevant registration number(s), if available.

Article 114

Harmonisation of classification and labelling

Harmonised classification and labelling at Community
1.
level shall,
from … (*), normally be added to Annex I of
Directive 67/548/EEC for classification of a substance as carci-
nogenic, mutagenic or toxic for reproduction category 1, 2 or
3, or as a respiratory sensitiser. Harmonised classification and
labelling for other effects may also be added to Annex I of
Directive 67/548/EEC on a case-by-case basis if justification is
provided demonstrating the need for action at Community
level. To this end, Member State competent authorities may
submit proposals to the Agency for harmonised classification
and labelling in accordance with Annex XV.

2.
The Risk Assessment Committee shall adopt an opinion
on the proposal, giving parties concerned the opportunity to
comment. The Agency shall
forward this opinion and any
comments to the Commission, which shall take a decision in
accordance with Article 4(3) of Directive 67/548/EEC.

Article 115

Transitional arrangements

The obligations set out in Article 112 shall apply from … (**).

TITLE XII

INFORMATION

Article 116

The first report shall be submitted by … (***).

Reporting

Every five years, Member States shall submit

to the
1.
Commission a report on the operation of this Regulation in
their respective territories, including sections on evaluation and
enforcement as described in Article 126.

The first report shall be submitted by … (**).

3.
Every five years, the Commission shall publish a general
report on the experience acquired with the operation of this
Regulation,
including the information referred to in para-
graphs 1 and 2.

The first report shall be published by … (****).

Article 117

Access to information

2.
Every five years, the Agency shall submit to the Commis-
sion a report on the operation of this Regulation. The Agency
shall include in its report information on the joint submission
of information in accordance with Article 11 and an overview
of
the explanations given for submitting information sepa-
rately.

Regulation (EC) No 1049/2001 shall apply to documents

1.
held by the Agency.

(*) Date of entry into force of this Regulation.
(**) Three years after the entry into force of this Regulation.
(***) Four years after entry into force of this Regulation.
(****) Five years after entry into force of this Regulation.

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2.
Disclosure of the following information shall normally be
deemed to undermine the protection of the commercial inter-
ests of the concerned person:

(h) the guidance on safe use provided in accordance with

sections 4 and 5 of Annex VI;

(a) details of the full composition of a preparation;

(b) the precise use, function or application of a substance or

preparation;

(c) the precise tonnage of the substance or preparation manu-

factured or placed on the market;

(d) links between a manufacturer or importer and his down-

stream users.

Where urgent action is essential
to protect human health,
safety or the environment, such as emergency situations, the
Agency may disclose the information referred to in this para-
graph.

3.
The Management Board shall adopt the practical arrange-
ments for implementing Regulation (EC) No 1049/2001 by
… (*).

4.
Decisions taken by the Agency pursuant to Article 8 of
Regulation (EC) No 1049/2001 may form the subject of a
complaint to the Ombudsman or of an action before the Court
of Justice, under the conditions laid down in Articles 195 and
230 of the Treaty respectively.

(i) analytical methods

requested in accordance with
Annexes IX or X which make it possible to detect a
dangerous substance when discharged into the environment
as well as to determine the direct exposure of humans.

if

2.
The following information on substances whether on
their own, in preparations or in articles, shall be made publicly
available, free of charge, over the Internet in accordance with
Article 76(2)(d) except where a party submitting the informa-
tion submits a justification in accordance with Article 10(a)(xi),
accepted as valid by the Agency, as to why such publication is
potentially harmful for the commercial interests of the regis-
trant or any other party concerned:

(a) if essential to classification and labelling, the degree of
purity of the substance and the identity of impurities and/
or additives which are known to be dangerous;

(b) the total tonnage band (i.e. 1-10 tonnes, 10-100 tonnes,
100-1 000 tonnes or over 1 000 tonnes) within which a
particular substance has been registered;

(c) the study summaries or robust study summaries of the

information referred to in paragraph 1(e) and (f);

(d) information, other

than that

listed in paragraph 1,

contained in the safety data sheet.

Article 118

Electronic public access

Article 119

1.
The following information held by the Agency on
substances whether on their own, in preparations or in articles,
shall be made publicly available,
free of charge, over the
Internet in accordance with Article 76(2)(d):

(a) the trade name(s) of the substance;

(b) the name in the IUPAC Nomenclature,

for dangerous

substances within the meaning of Directive 67/548/EEC;

(c) if applicable, the name of the substance as given in EINECS;

(d) the classification and labelling of the substance;

(e) physicochemical data concerning the substance and on

pathways and environmental fate;

(f) the result of each toxicological and ecotoxicological study;

Cooperation with third countries and international organi-
sations

Notwithstanding Articles 117 and 118,
information received
by the Agency under this Regulation may be disclosed to any
government or national authority of a third country or an
international organisation in accordance with an agreement
concluded between the Community and the third party
concerned under Regulation (EC) No 304/2003 of the Euro-
pean Parliament and of
the Council of 28 January 2003
concerning the export and import of dangerous chemicals (1) or
under Article 181a (3) of the Treaty, provided that both the
following conditions are met:

(a) the purpose of the agreement is cooperation on the imple-
mentation or management of legislation concerning chemi-
cals covered by this Regulation;

(g) any derived no-effect level (DNEL) or predicted no-effect
established in accordance with

concentration (PNEC)
Annex I;

(b) the third party protects the confidential

information as

mutually agreed.

(*) 12 months after entry into force of this Regulation.

(1) OJ L 63, 6.3.2003, p. 1. Regulation as last amended by Commission

Regulation (EC) No 777/2006 (OJ L 136, 24.5.2006, p. 9).

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TITLE XIII

COMPETENT AUTHORITIES

Article 120

Appointment

shall appoint

Member States
the competent authority or
competent authorities responsible for performing the tasks
allotted to competent authorities under this Regulation and for
cooperating with the Commission and the Agency in the imple-
mentation of
shall place
adequate resources at the disposal of the competent authorities
to enable them,
in conjunction with any other available
resources, to fulfil their tasks under this Regulation in a timely
and effective manner.

this Regulation. Member States

where this is considered necessary for the protection of human
health or the environment. The Commission shall draw up
guidelines in accordance with the procedure referred to in
Article 132(3) with a view to coordinating Member States in
these activities.

Article 123

Other responsibilities

Article 121

Cooperation between competent authorities

The competent authorities shall cooperate with each other in
the performance of their tasks under this Regulation and shall
give the competent authorities of other Member States all the
necessary and useful support to this end.

Article 122

Communication to the public of information on risks of
substances

The competent authorities of the Member States shall inform
the risks arising from substances
the general public about

Competent authorities shall submit electronically to the Agency
any available information that they hold on substances regis-
tered in accordance with Article 12(1) whose dossiers do not
contain the full information referred to in Annex VII, in par-
ticular whether enforcement or monitoring activities have iden-
tified suspicions of risk. The competent authority shall update
this information as appropriate.

Member States shall establish national helpdesks to provide
advice to manufacturers, importers, downstream users and any
other interested parties on their respective responsibilities and
obligations under this Regulation, in particular in relation to
the registration of substances in accordance with Article 12(1),
in addition to the operational guidance documents provided by
the Agency under Article 76(2)(f).

TITLE XIV

ENFORCEMENT

Article 124

Tasks of the Member States

shall notify it without delay of any subsequent amendment
affecting them.

Member States shall maintain a system of official controls and
other activities as appropriate to the circumstances.

Article 125

Penalties for non-compliance

Member States shall
lay down the provisions on penalties
applicable for infringement of the provisions of this Regulation
and shall take all measures necessary to ensure that they are
implemented. The penalties provided for must be effective,
proportionate and dissuasive. The Member States shall notify
those provisions to the Commission no later than … (*) and

Article 126

Report

in relation to
The report referred to in Article 116(1) shall,
enforcement, include the results of the official inspections, the
monitoring carried out, the penalties provided for and the
other measures taken pursuant to Articles 124 and 125 during
the previous reporting period. The common issues to be
covered in the reports shall be agreed by the Forum. The
Commission shall make these reports available to the Agency
and the Forum.

TITLE XV

TRANSITIONAL AND FINAL PROVISIONS

Article 127

Free movement

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.

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

(*) 18 months after entry into force of this Regulation.

2.
Nothing in this Regulation shall prevent Member States
from maintaining or laying down national rules to protect

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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.

Article 132

Committee procedure

Article 128

Safeguard clause

justifiable grounds

for
1. Where a Member State has
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 provi-
sional 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
information on which the provisional
scientific or technical
measure is based.

2.
The Commission shall take a decision in accordance with
the procedure referred to in Article 132(3) within 60 days of
receipt of the information from the Member State. This deci-
sion shall either:

(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 point (a) of
paragraph 2, 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 point (a) of
paragraph 2, the Commission shall consider whether this Regu-
lation needs to be adapted.

Article 129

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 130

Amendments to the Annexes

The Annexes may be amended in accordance with the proce-
dure referred to in Article 132(3).

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.

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

4.

The Committee shall adopt its Rules of Procedure.

Article 133

Transitional measures regarding the Agency

The Commission shall provide the necessary support

1.
towards the setting up of the Agency.

such time as

that purpose, until
is appointed in accordance with Article 83,

the Executive
2.
For
the
Director
the Agency,
thereby using the
Commission, on behalf of
budget provided for
latter, may appoint personnel,
the
including a person who shall fulfil the administrative functions
of the Executive Director on an interim basis, and conclude
other contracts.

Article 134

Transitional measures regarding notified substances

The requests to notifiers to provide further information to
1.
the competent authority in accordance with Article 16(2) of
Directive 67/548/EEC, shall be considered as decisions adopted
in accordance with Article 50 of this Regulation.

The requests to a notifier to provide further information
2.
for a substance in accordance with Article 16(1) of Directive
67/548/EEC,
shall be considered as decisions adopted in
accordance with Article 51 of this Regulation.

Such substance shall be regarded as being included in the Com-
munity rolling action plan in accordance with Article 43(2) of
this Regulation and shall be regarded as being chosen in
accordance with Article 44(2) of
this Regulation by the
Member State whose competent authority has requested further
of
information
Directive 67/548/EEC.

accordance with

Article

16(1)

in

Article 131

Transitional measures regarding existing substances

Implementing legislation

The measures necessary for the efficient implementation of this
Regulation shall be adopted in accordance with the procedure
referred to in Article 132(3).

1.
The requests to manufacturers and importers to submit
information to the Commission made by a Commission Regu-
lation in application of Article 10(2) of Regulation (EEC)
No 793/93, shall be considered as decisions adopted in accord-
ance with Article 51 of this Regulation.

Article 135

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The competent authority for the substance shall be the compe-
tent authority from the Member State identified as rapporteur
in accordance with Article 10(1) of Regulation (EEC) No 793/93
and shall carry out the tasks of Article 45(3) and Article 47 of
this Regulation.

2.
Until … (**), any dossier referred to in Article 128(3)
shall be submitted to the Commission. The Commission shall,
if necessary, prepare a draft amendment to Annex XVII.

The requests to manufacturers and importers to submit
2.
information to the Commission made by a Commission Regu-
lation in application of Article 12(2) of Regulation (EEC)
No 793/93, shall be considered as decisions adopted in accord-
ance with Article 51 of this Regulation. The Agency shall iden-
tify the competent authority for the substance to carry out the
tasks of Article 45(3) and Article 47 of this Regulation.

A Member State whose rapporteur has not forwarded by
3.
… (*) the risk evaluation and, where appropriate, the strategy
for limiting the risks, in accordance with Article 10(3) of Regu-
lation (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 68(4) of this Regulation on the basis of the

information referred to in point (a); and

Article 137

Review

1.
By … (***), the Commission shall carry out a review to
assess whether or not to extend the application of the obliga-
tion to perform a chemical safety assessment and to document
it in a chemical safety report to substances not covered by this
to registration or
obligation because they are not subject
subject to registration but manufactured or imported in quanti-
ties of less than 10 tonnes per year. On the basis of this review,
the Commission may, if appropriate, present legislative propo-
sals to extend this obligation.

(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 Regu-
lation.

The Commission may present

2.
legislative proposals as
soon as a practicable and cost-efficient way of selecting poly-
mers for registration on the basis of sound technical and valid
scientific criteria can be established, and after publishing a
report on the following:

The information referred to above shall be submitted to the
Agency by … (**).

Article 136

Transitional measures regarding restrictions

By … (**), the Commission shall, if necessary, prepare a
1.
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 accord-
ance 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;

(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 environ-
ment on the other.

The report, referred to in Article 116(3), on the experi-
3.
ence 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 1 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 require-
ments for substances manufactured or imported in quantities of
1 tonne or more up to 10 tonnes per year per manufacturer or
importer,
for
example in relation to alternative testing and (quantitative)
structure-activity relationships ((Q)SARs).

the latest developments,

taking into account

(b) any proposal, which has been submitted to the relevant
institutions but has not yet been adopted, concerning the
introduction of restrictions under Directive 76/769/EEC.

The Commission shall carry out a review of Annexes I, IV
4.
and V by … (*), with a view to proposing amendments,
if
appropriate, to them in accordance with the procedure referred
to in Article 132(3).

(*) 12 months after entry into force of this Regulation.
(**) 18 months after entry into force of this Regulation.

(***) 12 years after entry into force of this Regulation.

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Article 138

Repeals

Directives 76/769/EEC and 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 … (**).

Article 140

Entry into force and application

1.
This Regulation shall enter into force on the twentieth
day following that of its publication in the Official Journal of the
European Union.

References to the repealed acts shall be construed as references
to this Regulation.

Titles II, III, V, VI, VII, XI and XII as well as Articles 127

2.
and 135 shall apply from … (*).

Article 139

Amendment of Directive 1999/45/EC

Article 14 of Directive 1999/45/EC shall be deleted.

3.

4.

Article 134 shall apply from … (**).

Articles 68 to 72 shall apply from … (***).

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at …

For the European Parliament

The President

…

For the Council

The President

…

(*) 12 months after entry into force of this Regulation.
(**) 14 months after entry into force of this Regulation.

(***) 18 months after entry into force of this Regulation.

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LIST OF ANNEXES

ANNEX I

GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL
SAFETY REPORTS . . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . . .. . . . . . . . .. . . . . . . . .. . . .

ANNEX II

GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS . .. . . . . . . . .. . . . . . . . . .. . . . . . . . .. . . . . . . . .. . . .

ANNEX III

CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES

ANNEX IV

EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE
2(7)(a). . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . . .. . . . . . . . .. . . . . . . . .. . . .

ANNEX V

EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE
2(7)(b) . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . . .. . . . . . . . .. . . . . . . . .. . . .

ANNEX VI

INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10 . . . .. . . . . . . . . .. . . . . . . . .. . . . . . . . .. . . .

ANNEX VII

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR
IMPORTED IN QUANTITIES OF 1 TONNE OR MORE.. . . . . . . . .. . . . . . . . .. . . . . . . . . .. . . . . . . . .. . . . . . . . .. . . .

ANNEX VIII ADDITIONAL STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFAC-
TURED OR IMPORTED IN QUANTITIES OF 10 TONNES OR MORE . . . . . . . . . .. . . . . . . . .. . . . . . . . .. . . .

ANNEX IX

ADDITIONAL STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFAC-
TURED OR IMPORTED IN QUANTITIES OF 100 TONNES OR MORE. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . .

ANNEX X

ADDITIONAL STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFAC-
TURED OR IMPORTED IN QUANTITIES OF 1000 TONNES OR MORE . . . . . . .. . . . . . . . .. . . . . . . . .. . . .

ANNEX XI

GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN
ANNEXES VII TO X . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . . .. . . . . . . . .. . . . . . . . .. . . .

ANNEX XII

GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND
PREPARE CHEMICAL SAFETY REPORTS . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . . .. . . . . . . . .. . . . . . . . .. . . .

ANNEX XIII

CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC
SUBSTANCES, AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES . . .. . . .

ANNEX XIV

LIST OF SUBSTANCES SUBJECT TO AUTHORISATION. . . . . . . .. . . . . . . . .. . . . . . . . . .. . . . . . . . .. . . . . . . . .. . . .

ANNEX XV

DOSSIERS .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . . .. . . . . . . . .. . . . . . . . .. . . .

ANNEX XVI

SOCIO-ECONOMIC ANALYSIS . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . .. . . . . . . . . .. . . . . . . . .. . . . . . . . .. . . .

ANNEX XVII RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF
CERTAIN DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES . . . .. . . . . . . . .. . . . . . . . .. . . .

66

78

87

88

92

93

97

101

105

110

113

116

118

119

120

122

123

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GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS

ANNEX I

0.

INTRODUCTION

0.1.

The purpose of this Annex is to set out how manufacturers and importers are to assess and document that the
risks arising from the substance they manufacture or import are adequately controlled during manufacture and
their own use(s) and that others further down the supply chain can adequately control the risks.

0.2.

The chemical safety assessment shall be prepared by one or more competent person(s) who have appropriate
experience and received appropriate training, including refresher training.

0.3.

0.4.

0.5.

The chemical safety assessment of a manufacturer shall address the manufacture of a substance and all the identi-
fied uses. The chemical safety assessment of an importer shall address all identified uses. The chemical safety
assessment shall consider the use of the substance on its own (including any major impurities and additives), in a
preparation and in an article, as defined by the identified uses. The assessment shall consider all stages of the life-
cycle of the substance resulting from the manufacture and identified uses. The chemical safety assessment shall be
based on a comparison of the potential adverse effects of a substance with the known or reasonably foreseeable
exposure of man and/or the environment to that substance taking into account implemented and recommended
risk management measures and operational conditions.

Substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow
a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. If
the manufacturer or importer considers that the chemical safety assessment carried out for one substance is suffi-
cient to assess and document that the risks arising from another substance or from a group or ‘category’ of
substances are adequately controlled then he can use that chemical safety assessment for the other substance or
group or ‘category’ of substances. The manufacturer or importer shall provide a justification for this.

The chemical safety assessment shall be based on the information on the substance contained in the technical
dossier and on other available and relevant information. Manufacturers or importers submitting a proposal for
testing in accordance with Annexes IX and X shall record this under the relevant heading of the chemical safety
report. Available information from assessments carried out under other international and national programmes
shall be included. Where available and appropriate, an assessment carried out under Community legislation (e.g.
risk assessments completed under Regulation (EEC) No 793/93) shall be taken into account in the development
of, and reflected in, the chemical safety report. Deviations from such assessments shall be justified.

Thus the information to be considered includes information related to the hazards of the substance, the exposure
arising from the manufacture or import, the identified uses of the substance, operational conditions and risk
management measures applied or recommended to downstream users to be taken into account.

In accordance with section 3 of Annex XI in some cases, it may not be necessary to generate missing information,
because risk management measures and operational conditions which are necessary to control a well-charac-
terised risk may also be sufficient to control other potential risks, which will not therefore need to be charac-
terised precisely.

If the manufacturer or importer considers that further information is necessary for producing his chemical safety
report and that this information can only be obtained by performing tests in accordance with Annex IX or X, he
shall submit a proposal for a testing strategy, explaining why he considers that additional information is necessary
and record this in the chemical safety report under the appropriate heading. While waiting for results of further
testing, he shall record in his chemical safety report, and include in the exposure scenario developed, the interim
risk management measures that he has put in place and those he recommends to downstream users intended to
manage the risks being explored.

0.6. A chemical safety assessment performed by a manufacturer or an importer for a substance shall include the

following steps in accordance with the respective sections of this Annex:

1. Human health hazard assessment

2. Human health hazard assessment of physicochemical properties

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3. Environmental hazard assessment

4. PBT and vPvB assessment

If as a result of steps 1 to 4 the manufacturer or importer concludes that the substance or the preparation meets
the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or is
assessed to be a PBT or vPvB, the chemical safety assessment shall also consider the following steps:

5. Exposure assessment

5.1. The generation of exposure scenario(s) or the generation of relevant use and exposure categories if appro-

priate

5.2. Exposure estimation

6. Risk characterisation

A summary of all the relevant information used in addressing the points above, shall be presented under the rele-
vant heading of the Chemical Safety Report (Section 7).

0.7.

The main element of the exposure part of the chemical safety report is the description of the exposure scenario(s)
implemented for the manufacturer's production, the manufacturer or importer's own use, and those recom-
mended by the manufacturer or importer to be implemented for the identified use(s).

An exposure scenario is the set of conditions that describe how the substance is manufactured or used during its
life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, expo-
sures of humans and the environment. These sets of conditions contain a description of both the risk manage-
ment measures and operational conditions which the manufacturer or importer has implemented or recommends
to be implemented by downstream users.

If the substance is placed on the market, the relevant exposure scenario(s),
including the risk management
measures and operational conditions shall be included in an annex to the safety data sheet in accordance with
Annex II.

0.8.

The level of detail required in describing an exposure scenario will vary substantially from case to case, depending
on the use of a substance, its hazardous properties and the amount of information available to the manufacturer
or importer. Exposure scenarios may describe the appropriate risk management measures for several individual
processes or uses of a substance. An exposure scenario may thereby cover a large range of processes or uses.
Exposure scenarios covering a wide range of processes or uses may be referred to as Exposure Categories. Further
mention of Exposure Scenario in this Annex and Annex II includes Exposure Categories if they are developed.

0.9. Where information is not necessary in accordance with Annex XI, this fact shall be stated under the appropriate
heading of the chemical safety report and a reference shall be made to the justification in the technical dossier.
The fact that no information is required shall also be stated in the safety data sheet.

0.10.

In relation to particular effects, such as ozone depletion, photochemical ozone creation potential, strong odour
and tainting, for which the procedures set out in sections 1 to 6 are impracticable, the risks associated with such
effects shall be assessed on a case-by-case basis and the manufacturer or importer shall include a full description
and justification of such assessments in the chemical safety report and summarised in the safety data sheet.

0.11. When assessing the risk of the use of one or more substances incorporated into a special preparation (for instance
alloys), the way the constituent substances are bonded in the chemical matrix shall be taken into account.

0.12. Where the methodology described in this Annex is not appropriate, details of alternative methodology used shall

be explained and justified in the chemical safety report.

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0.13. Part A of the chemical safety report shall include a declaration that the risk management measures outlined in the
relevant exposure scenarios for the manufacturer's or importer's own use(s) are implemented by the manufacturer
or importer and that those exposure scenarios for the identified uses are communicated to distributors and down-
stream users in the safety data sheet(s).

1.

HUMAN HEALTH HAZARD ASSESSMENT

1.0.

Introduction

1.0.1. The objective of the human health hazard assessment shall be:

— to determine the classification and labelling of a substance in accordance with Directive 67/548/EEC; and

— to derive levels of exposure to the substance above which humans should not be exposed. This level of expo-

sure is known as the Derived No-Effect Level (DNEL).

1.0.2. The human health hazard assessment shall consider the toxicokinetic profile (i.e. absorption, metabolism, distribu-
tion and elimination) of the substance and the following groups of effects, (1) acute effects (acute toxicity, irrita-
tion and corrosivity), (2) sensitisation, (3) repeated dose toxicity and (4) CMR effects (carcinogenity, mutagenicity
and toxicity for reproduction). Based on all the available information, other effects shall be considered when
necessary.

1.0.3. The hazard assessment shall comprise the following four steps:

Step 1: Evaluation of non-human information

Step 2: Evaluation of human information

Step 3: Classification and Labelling

Step 4: Derivation of DNELs

1.0.4. The first three steps shall be undertaken for every effect for which information is available and shall be recorded
under the relevant section of the Chemical Safety Report and where required and in accordance with Article 31,
summarised in the Safety Data Sheet under headings 2 and 11.

1.0.5. For any effect for which no relevant information is available, the relevant section shall contain the sentence ‘This
information is not available’. The justification, including reference to any literature search carried out, shall be
included in the technical dossier.

1.0.6. Step 4 of the human health hazard assessment shall be undertaken by integrating the results from the first three
steps and shall be included under the relevant heading of the Chemical Safety Report and summarised in the
Safety Data Sheet under heading 8.1.

1.1.

Step 1: Evaluation of non-human information

1.1.1. The evaluation of non-human information shall comprise:

— the hazard identification for the effect based on all available non-human information;

— the establishment of the quantitative dose (concentration) — response (effect) relationship.

1.1.2. When it is not possible to establish the quantitative dose (concentration) — response (effect) relationship, then
this should be justified and a semi-quantitative or qualitative analysis shall be included. For instance, for acute
effects it is usually not possible to establish the quantitative dose (concentration) — response (effect) relationship
on the basis of the results of a test conducted in accordance with test methods laid down in a Commission Regu-
lation as specified in Article 13(2). In such cases it suffices to determine whether and to which degree the
substance has an inherent capacity to cause the effect.

1.1.3. All non-human information used to assess a particular effect on humans and to establish the dose (concentration)
— response (effect) relationship, shall be briefly presented, if possible in the form of a table or tables, distin-
guishing between in vitro,
in vivo and other information. The relevant test results (e.g. LD50, NO(A)EL or
LO(A)EL) and test conditions (e.g. test duration, route of administration) and other relevant information shall be
presented, in internationally recognised units of measurement for that effect.

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1.1.4. If one study is available then a robust study summary should be prepared for that study. If there are several
studies addressing the same effect, then, having taken into account possible variables (e.g. conduct, adequacy, rele-
vance of test species, quality of results etc.), normally the study or studies giving rise to the highest concern shall
be used to establish the DNELs and a robust study summary shall be prepared for that study or studies and
included as part of the technical dossier. Robust summaries will be required of all key data used in the hazard
assessment. If the study or studies giving rise to the highest concern are not used, then this shall be fully justified
and included as part of the technical dossier, not only for the study being used but also for all studies demon-
strating a higher concern than the study being used. It is important irrespective of whether hazards have been
identified or not that the validity of the study be considered.

1.2.

Step 2: Evaluation of human information

If no human information is available, this part shall contain the statement ‘No human information is available’.
However, if human information is available, it shall be presented, if possible in the form of a table.

1.3.

Step 3: Classification and Labelling

1.3.1. The appropriate classification and labelling developed in accordance with the criteria in Directive 67/548/EEC
shall be presented and justified. Where applicable Specific Concentration limits, resulting from the application of
Article 4(4) of Directive 67/548/EEC and Articles 4 to 7 of Directive 1999/45/EC, shall be presented and, if they
are not included in Annex I to Directive 67/548/EEC, justified. The assessment should always include a statement
as to whether the substance fulfils or does not fulfil the criteria given in Directive 67/548/EEC for CMR, cate-
gories 1 and 2.

1.3.2. If the information is inadequate to decide whether a substance should be classified for a particular end-point, the

registrant shall indicate and justify the action or decision he has taken as a result.

1.4.

Step 4: Identification of DNEL(s)

1.4.1. Based on the outcomes of steps 1 and 2, (a) DNEL(s) shall be established for the substance, reflecting the likely
route(s), duration and frequency of exposure. For some endpoints, especially mutagenicity and carcinogenicity,
the available information may not enable a threshold, and therefore a DNEL, to be established. If justified by the
exposure scenario(s), a single DNEL may be sufficient. However, taking into account the available information
and the exposure scenario(s) in Section 9 of the Chemical Safety Report it may be necessary to identify different
DNELs for each relevant human population (e.g. workers, consumers and humans liable to exposure indirectly via
the environment) and possibly for certain vulnerable sub-populations (e.g. children, pregnant women) and for
different routes of exposure. A full justification shall be given specifying, inter alia, the choice of the information
used, the route of exposure (oral, dermal, inhalation) and the duration and frequency of exposure to the substance
for which the DNEL is valid. If more than one route of exposure is likely to occur, then a DNEL shall be estab-
lished for each route of exposure and for the exposure from all routes combined. When establishing the DNEL,
the following factors shall, inter alia, be taken into account:

(a) the uncertainty arising, among other factors, from the variability in the experimental information and from

intra- and inter-species variation;

(b) the nature and severity of the effect;

(c) the sensitivity of the human (sub-)population to which the quantitative and/or qualitative information on

exposure applies.

1.4.2. If it is not possible to identify a DNEL, then this shall be clearly stated and fully justified.

2.

PHYSICOCHEMICAL HAZARD ASSESSMENT

2.1.

The objective of the hazard assessment for physicochemical properties shall be to determine the classification and
labelling of a substance in accordance with Directive 67/548/EEC.

2.2. As a minimum, the potential effects to human health shall be assessed for the following physicochemical proper-

ties:

— explosivity,

— flammability,

— oxidising potential.

If the information are inadequate to decide whether a substance should be classified for a particular end-point,
the registrant shall indicate and justify the action or decision he has taken as a result.

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2.3.

The assessment of each effect shall be presented under the relevant heading of the Chemical Safety Report
(Section 7) and where required and in accordance with Article 31, summarised in the Safety Data Sheet under
headings 2 and 9.

2.4.

For every physicochemical property, the assessment shall entail an evaluation of the inherent capacity of the
substance to cause the effect resulting from the manufacture and identified uses.

2.5.

The appropriate classification and labelling developed in accordance with the criteria in Directive 67/548/EEC
shall be presented and justified.

3.

ENVIRONMENTAL HAZARD ASSESSMENT

3.0.

Introduction

3.0.1. The objective of the environmental hazard assessment shall be to determine the classification and labelling of a
substance in accordance with Directive 67/548/EEC and to identify the concentration of the substance below
which adverse effects in the environmental sphere of concern are not expected to occur. This concentration is
known as the Predicted No-Effect Concentration (PNEC).

3.0.2. The environmental hazard assessment shall consider the potential effects on the environment, comprising the
(1) aquatic (including sediment), (2) terrestrial and (3) atmospheric compartments, including the potential effects
that may occur (4) via food-chain accumulation. In addition, the potential effects on the (5) microbiological
activity of sewage treatment systems shall be considered. The assessment of the effects on each of these
five environmental spheres shall be presented under the relevant heading of
the Chemical Safety Report
(Section 7) and where required and in accordance with Article 31, summarised in the Safety Data Sheet under
headings 2 and 12.

3.0.3. For any environmental sphere, for which no effect information is available, the relevant section of the chemical
safety report shall contain the sentence ‘This information is not available’. The justification, including reference to
any literature research carried out, shall be included in the technical dossier. For any environmental sphere for
which information is available, but the manufacturer or importer believes that it is not necessary to conduct the
hazard assessment, the manufacturer or importer shall present a justification, with reference to pertinent informa-
tion, under the relevant heading of the Chemical Safety Report (Section 7) and where required and in accordance
with Article 31, summarised in the Safety Data Sheet under heading 12.

3.0.4. The hazard assessment shall comprise the following three steps, which shall be clearly identified as such in the

Chemical Safety Report:

Step 1: Evaluation of information

Step 2: Classification and Labelling

Step 3: Derivation of the PNEC

3.1.

Step 1: Evaluation of information

3.1.1. The evaluation of all available information shall comprise:

— the hazard identification based on all available information,

— the establishment of the quantitative dose (concentration) — response (effect) relationship.

3.1.2. When it is not possible to establish the quantitative dose (concentration) — response (effect) relationship, then

this should be justified and a semi-quantitative or qualitative analysis shall be included.

3.1.3. All information used to assess the effects on a specific environmental sphere shall be briefly presented, if possible
in the form of a table or tables. The relevant test results (e.g. LC50 or NOEC) and test conditions (e.g. test dura-
tion, route of administration) and other relevant information shall be presented, in internationally recognised
units of measurement for that effect.

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3.1.4. All information used to assess the environmental fate of the substance shall be briefly presented, if possible in the
form of a table or tables. The relevant test results and test conditions and other relevant information shall be
presented, in internationally recognised units of measurement for that effect.

3.1.5. If one study is available then a robust study summary should be prepared for that study. Where there are more
than one studies addressing the same effect, then the study or studies giving rise to the highest concern shall be
used to draw a conclusion and a robust study summary shall be prepared for that study or studies and included
as part of the technical dossier. Robust summaries will be required of all key data used in the hazard assessment.
If the study or studies giving rise to the highest concern are not used, then this shall be fully justified and included
as part of the technical dossier, not only for the study being used but also for all studies reaching a higher
concern than the study being used. For substances where all available studies indicate no hazards an overall
assessment of the validity of all studies should be performed.

3.2.

Step 2: Classification and Labelling

3.2.1. The appropriate classification and labelling developed in accordance with the criteria in Directive 67/548/EEC
shall be presented and justified. Where applicable Specific Concentration limits, resulting from the application of
Article 4(4) of Directive 67/548/EEC and Articles 4 to 7 of Directive 1999/45/EC, shall be presented and, if they
are not included in Annex I to Directive 67/548/EEC, justified.

3.2.2. If the information are inadequate to decide whether a substance should be classified for a particular end-point,

the registrant shall indicate and justify the action or decision he has taken as a result.

3.3.

Step 3: Identification of the PNEC

3.3.1. Based on the available information, the PNEC for each environmental sphere shall be established. The PNEC may
be calculated by applying an appropriate assessment factor to the effect values (e.g. LC50 or NOEC). An assess-
ment factor expresses the difference between effects values derived for a limited number of species from labora-
tory tests and the PNEC for the environmental sphere (1).

3.3.2. If it is not possible to derive the PNEC, then this shall be clearly stated and fully justified.

4.

PBT AND VPVB ASSESSMENT

4.0.

Introduction

4.0.1. The objective of the PBT and vPvB assessment shall be to determine if the substance fulfils the criteria given in
Annex XIII and if so, to characterise the potential emissions of the substance. A hazard assessment in accordance
with Sections 1 and 3 of this Annex addressing all the long-term effects and the estimation of the long-term
exposure of humans and the environment as carried out in accordance with Section 5 (Exposure Assessment),
step 2 (Exposure Estimation), cannot be carried out with sufficient reliability for substances satisfying the PBT and
vPvB criteria in Annex XIII. Therefore, a separate PBT and vPvB assessment is required.

4.0.2. The PBT and vPvB assessment shall comprise the following two steps, which shall be clearly identified as such in

Part B, Section 8 of the Chemical Safety Report:

Step 1: Comparison with the Criteria

Step 2: Emission Characterisation

The assessment shall also be summarised in the Safety Data Sheet under heading 12.

4.1.

Step 1: Comparison with the Criteria

This part of the PBT and vPvB assessment shall entail the comparison of the available information, which is
submitted as part of the technical dossier, with the criteria given in Annex XIII and a statement of whether the
substance fulfils or does not fulfil the criteria.

If the available information is not sufficient to decide whether the substance fulfils the criteria in Annex XIII, then
other evidence like monitoring data available for the registrant and giving rise to an equivalent level of concern
shall be considered on a case-by-case basis.

(1) In general, the more extensive the data and the longer the duration of the tests, the smaller is the degree of uncertainty and the size of
the assessment factor. An assessment factor of 1 000 is typically applied to the lowest of three short term L(E)C50 values derived
from species representing different trophic levels and a factor of 10 to the lowest of three long-term NOEC values derived from
species representing different trophic levels.

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If the technical dossier contains for one or more endpoints only information as required in Annexes VII and VIII,
the registrant shall consider information relevant for screening for P, B and T properties to decide whether
further information needs to be generated to fulfil the objective of the PBT and vPvB assessment. In case the
generation of further information is necessary and would require testing on vertebrate animals, the registrant
shall submit a testing proposal. However, such further information does not need to be generated if the registrant
implements or recommends sufficient risk management measures and operational conditions that enable deroga-
tion according to Section 3 of Annex XI from testing relevant for PBT and vPvB assessment.

4.2.

Step 2: Emission Characterisation

If the substance fulfils the criteria an emission characterisation shall be conducted comprising the relevant parts
of the exposure assessment as described in Section 5. In particular it shall contain an estimation of the amounts
of the substance released to the different environmental compartments during all activities carried out by the
manufacturer or importer and all identified uses, and an identification of the likely routes by which humans and
the environment are exposed to the substance.

5.

EXPOSURE ASSESSMENT

5.0.

Introduction

The objective of the exposure assessment shall be to make a quantitative or qualitative estimate of the dose/
concentration of the substance to which humans and the environment are or may be exposed. The assessment
shall consider all stages of the life-cycle of the substance resulting from the manufacture and identified uses and
shall cover any exposures that may relate to the hazards identified in sections 1 to 4. The exposure assessment
shall entail the following two steps, which shall be clearly identified as such in the Chemical Safety Report:

Step 1: Generation of exposure scenario(s) or the generation of relevant use and exposure categories

Step 2: Exposure Estimation

Where required and in accordance with Article 31, the exposure scenario shall also be included in an annex to
the Safety Data Sheet.

5.1.

Step 1: Development of exposure scenarios

5.1.1. Exposure scenarios as described in sections 0.7 and 0.8 shall be generated. Exposure scenarios are the core of the
process to carry out a chemical safety assessment. The chemical safety assessment process may be iterative. The
first assessment will be based on the required minimum and all available hazard information and on the exposure
estimation that corresponds to the initial assumptions about the operating conditions and risk management
measures (an initial exposure scenario). If the initial assumptions lead to a risk characterisation indicating that
risks to human health and the environment are not adequately controlled, then it is necessary to carry out an
iterative process with amendment of one or a number of factors in hazard or exposure assessment with the aim
to demonstrate adequate control. The refinement of hazard assessment may require generation of additional
hazard information. The refinement of exposure assessment may involve appropriate alteration of the operational
conditions or risk management measures in the exposure scenario or more precise exposure estimation. The
exposure scenario, resulting from the final iteration (a final exposure scenario), shall be included in the chemical
safety report and attached to the safety data sheet in accordance with Article 31.

The final exposure scenario shall be presented under the relevant heading of the chemical safety report, and
included in an annex to the safety data sheet, using an appropriate short title giving a brief general description of
the use, consistent with those given in Section 3.5 of Annex VI. Exposure scenarios shall cover any manufacture
in the Community and all identified uses.

In particular, an exposure scenario includes, where relevant, a description of:

Operational conditions

— the processes involved, including the physical form in which the substance is manufactured, processed and/or

used,

— the activities of workers related to the processes and the duration and frequency of their exposure to the

substance,

— the activities of consumers and the duration and frequency of their exposure to the substance,

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— the duration and frequency of emissions of the substance to the different environmental compartments and

sewage treatment systems and the dilution in the receiving environmental compartment.

Risk management measures

— the risk management measures to reduce or avoid direct and indirect exposure of humans (including workers

and consumers) and the different environmental compartments to the substance,

— the waste management measures to reduce or avoid exposure of humans and the environment to the

substance during waste disposal and/or recycling.

5.1.2. Where a manufacturer, importer or downstream user applies for an application for an authorisation for a specific

use, exposure scenarios need only be developed for that use and the subsequent life-cycle steps.

5.2.

Step 2: Exposure Estimation

5.2.1. The exposure shall be estimated for each exposure scenario developed and shall be presented under the relevant
heading of the Chemical Safety Report and where required and in accordance with Article 31, summarised in an
annex to the safety data sheet. The exposure estimation entails three elements:
(1) emission estimation;
(2) assessment of chemical fate and pathways; and (3) estimation of exposure levels.

5.2.2. The emission estimation shall consider the emissions during all relevant parts of the life-cycle of the substance
resulting from the manufacture and each of the identified uses. The life-cycle stages resulting from the manufac-
ture of the substance cover, where relevant, the waste stage. The life-cycle stages resulting from identified uses
cover, where relevant, the service-life of articles and the waste stage. The emission estimation shall be performed
under the assumption that the risk management measures and operational conditions described in the exposure
scenario have been implemented.

5.2.3. A characterisation of possible degradation, transformation, or reaction processes and an estimation of environ-

mental distribution and fate shall be performed.

5.2.4. An estimation of the exposure levels shall be performed for all human populations (workers, consumers and
humans liable to exposure indirectly via the environment) and environmental spheres for which exposure to the
substance is known or reasonably foreseeable. Each relevant route of human exposure (inhalation, oral, dermal
and combined through all relevant routes and sources of exposure) shall be addressed. Such estimations shall take
account of spatial and temporal variations in the exposure pattern. In particular, the exposure estimation shall
take account of:

— adequately measured, representative exposure data,

— any major impurities and additives in the substance,

— the quantity in which the substance is produced and/or imported,

— the quantity for each identified use,

— implemented or recommended risk management, including the degree of containment,

— duration and frequency of exposure according to the operational conditions,

— the activities of workers related to the processes and the duration and frequency of their exposure to the

substance,

— the activities of consumers and the duration and frequency of their exposure to the substance,

— the duration and frequency of emissions of the substance to the different environmental compartments and

the dilution in the receiving environmental compartment,

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— the physicochemical properties of the substance,

— transformation and/or degradation products,

— the likely routes of exposure of and potential for absorption in humans,

— the likely pathways to the environment and environmental distribution and degradation and/or transformation

(see also Section 3 Step 1),

— scale (geographical) of exposure,

— matrix dependent release/migration of the substance.

5.2.5. Where adequately measured representative exposure data are available, special consideration shall be given to
them when conducting the exposure assessment. Appropriate models can be used for the estimation of exposure
levels. Relevant monitoring data from substances with analogous use and exposure patterns or analogous proper-
ties can also be considered.

6.

RISK CHARACTERISATION

6.1.

The risk characterisation shall be carried out for each exposure scenario and shall be presented under the relevant
heading of the Chemical Safety Report.

6.2.

The risk characterisation shall consider the human populations (exposed as workers, consumers or indirectly via
the environment and if relevant a combination thereof) and the environmental spheres for which exposure to the
substance is known or reasonably foreseeable, under the assumption that the risk management measures
described in the exposure scenarios in the Section 5 have been implemented. In addition, the overall environ-
mental risk caused by the substance shall be reviewed by integrating the results for the overall releases, emissions
and losses from all sources to all environmental compartments.

6.3.

The risk characterisation consists of:

— a comparison of the exposure of each human population known to be or likely to be exposed with the appro-

priate DNEL,

— a comparison of the predicted environmental concentrations in each environmental sphere with the PNECs,

and

— an assessment of the likelihood and severity of an event occurring due to the physicochemical properties of

the substance.

6.4.

For any exposure scenario, the risk to humans and the environment can be considered to be adequately
controlled, throughout the lifecycle of the substance that results from manufacture or identified uses, if:

— the exposure levels estimated in Section 6.2 do not exceed the appropriate DNEL or the PNEC, as determined

in Sections 1 and 3, respectively, and,

— the likelihood and severity of an event occurring due to the physicochemical properties of the substance as

determined in Section 2 is negligible.

6.5.

For those human effects and those environmental spheres for which it was not possible to determine a DNEL or
a PNEC, a qualitative assessment of the likelihood that effects are avoided when implementing the exposure
scenario shall be carried out.

For substances satisfying the PBT and vPvB criteria, the manufacturer or importer shall use the information as
obtained in Section 5, Step 2 when implementing on its site, and recommending for downstream users, risk
management measures which minimise exposures and emissions to humans and the environment, throughout
the lifecycle of the substance that results from manufacture or identified uses.

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7.

CHEMICAL SAFETY REPORT FORMAT

The Chemical Safety Report shall include the following headings:

CHEMICAL SAFETY REPORT FORMAT

PART A

1.

SUMMARY OF RISK MANAGEMENT MEASURES

2. DECLARATION THAT RISK MANAGEMENT MEASURES ARE IMPLEMENTED

3. DECLARATION THAT RISK MANAGEMENT MEASURES ARE COMMUNICATED

1.

IDENTITY OF THE SUBSTANCE AND PHYSICAL AND CHEMICAL PROPERTIES

PART B

2. MANUFACTURE AND USES

2.1. Manufacture

2.2. Identified uses

2.3. Uses advised against

3. CLASSIFICATION AND LABELLING

4.

ENVIRONMENTAL FATE PROPERTIES

4.1. Degradation

4.2. Environmental distribution

4.3. Bioaccumulation

4.4. Secondary Poisoning

5. HUMAN HEALTH HAZARD ASSESSMENT

5.1. Toxicokinetics (absorption, metabolism, distribution and elimination)

5.2. Acute toxicity

5.3.

Irritation

5.3.1. Skin

5.3.2. Eye

5.3.3. Respiratory Tract

5.4. Corrosivity

5.5.

Sensitisation

5.5.1. Skin

5.5.2. Respiratory system

5.6. Repeated dose toxicity

5.7. Mutagenicity

5.8. Carcinogenicity

5.9. Toxicity for reproduction

5.9.1. Effects on fertility

5.9.2. Developmental toxicity

5.10. Other effects

5.11. Derivation of DNEL(s)

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CHEMICAL SAFETY REPORT FORMAT

6. HUMAN HEALTH HAZARD ASSESSMENT OF PHYSICOCHEMICAL PROPERTIES

6.1. Explosivity

6.2. Flammability

6.3. Oxidising potential

7.

ENVIRONMENTAL HAZARD ASSESSMENT

7.1. Aquatic Compartment (including sediment)

7.2. Terrestrial Compartment

7.3. Atmospheric Compartment

7.4. Microbiological Activity in Sewage Treatment Systems

8.

PBT AND VPVB ASSESSMENT

9.

EXPOSURE ASSESSMENT

9.1.

[Title of Exposure Scenario 1]

9.1.1. Exposure Scenario

9.1.2. Exposure Estimation

9.2.

[Title of Exposure Scenario 2]

9.2.1. Exposure Scenario

9.2.2. Exposure Estimation

[etc.]

10. RISK CHARACTERISATION

10.1. [Title of Exposure Scenario 1]

10.1.1. Human Health

10.1.1.1. Workers

10.1.1.2. Consumers

10.1.1.3. Indirect exposure to humans via the environment

10.1.2. Environment

10.1.2.1. Aquatic Compartment (incl. Sediment)

10.1.2.2. Terrestrial Compartment

10.1.2.3. Atmospheric Compartment

10.1.2.4. Microbiological Activity in Sewage Treatment Systems

10.2. [Title of Exposure Scenario 2]

10.2.1. Human Health

10.2.1.1. Workers

10.2.1.2. Consumers

10.2.1.3. Indirect exposure to humans via the environment

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CHEMICAL SAFETY REPORT FORMAT

10.2.2. Environment

10.2.2.1. Aquatic Compartment (incl. Sediment)

10.2.2.2. Terrestrial Compartment

10.2.2.3. Atmospheric Compartment

10.2.2.4. Microbiological Activity in Sewage Treatment Systems

[etc.]

10.x. Overall exposure (combined for all relevant emission/release sources)

10.x.1. Human health (combined for all exposure routes)

10.x.1.1.

10.x.2. Environment (combined for all emission sources)

10.x.2.1.

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ANNEX II

GUIDE TO THE COMPILATION OF SAFETY DATA SHEETS

This Annex sets out the requirements for a Safety Data Sheet that is provided for a substance or a preparation in accord-
ance with Article 31. The Safety Data Sheet provides a mechanism for transmitting appropriate safety information on
classified substances and preparations, including information from the relevant Chemical Safety Report(s) down the
supply chain to the immediate downstream user(s). The information provided in the Safety Data Sheet shall be consistent
with the information in the Chemical Safety Report, where one is required. Where a Chemical Safety Report has been
performed, the relevant exposure scenario(s) shall be placed into an annex of the Safety Data Sheet, to make reference to
them under the relevant headings of the Safety Data Sheet easier.

The purpose of this Annex is to ensure consistency and accuracy in the content of each of the mandatory headings
listed in Article 31, so that the resulting Safety Data Sheets will enable users to take the necessary measures relating to
protection of human health and safety at the workplace, and protection of the environment.

The information provided by Safety Data Sheets shall also meet the requirements set out in Directive 98/24/EC on the
protection of the health and safety of workers from the risks related to chemical agents at work. In particular, the Safety
Data Sheet shall enable the employer to determine whether any hazardous chemical agents are present in the workplace,
and to assess any risk to the health and safety of workers arising from their use.

The information in the Safety Data Sheet shall be written in a clear and concise manner. The Safety Data Sheet shall be
prepared by a competent person who shall take into account the specific needs of the user audience, as far as it is
known. Persons placing substances and preparations on the market shall ensure that competent persons have received
appropriate training, including refresher training.

For preparations not classified as dangerous, but for which a Safety Data Sheet is required according to Article 31,
proportionate information shall be provided under each heading.

Additional information may be necessary in some cases in view of the wide range of properties of the substances and
preparations. If in other cases it emerges that information on certain properties is of no significance or that it is techni-
cally impossible to provide, the reasons for this shall be clearly stated under each heading. Information shall be provided
for each hazardous property. If it is stated that a particular hazard does not apply, clearly differentiate between cases
where no information is available to the classifier, and cases where negative test results are available.

Give the date of issue of the Safety Data Sheet on the first page. When a safety data sheet has been revised, the changes
shall be brought to the attention of the recipient and identify it as ‘Revision: (date)’.

Note

Safety data sheets are also required for certain special substances and preparations (e.g. metals in massive form, alloys,
compressed gases, etc.) listed in chapters 8 and 9 of Annex VI to Directive 67/548/EEC, for which there are labelling
derogations.

1.

IDENTIFICATION OF THE SUBSTANCE/PREPARATION AND OF THE COMPANY/UNDERTAKING

1.1.

Identification of the substance or preparation

The term used for identification shall be identical to that provided on the label as set out in Annex VI to
Directive 67/548/EEC.

For substances subject to registration, the term shall be consistent with that provided under registration and the
registration number assigned under Article 20(1) of this Regulation shall also be indicated.

Other means of identification available may also be indicated.

1.2. Use of the substance/preparation

Indicate the uses of the substance or preparation as far as they are known. Where there are many possible uses,
only the most important or common uses need to be listed. This shall include a brief description of what it actu-
ally does, e.g. flame retardant, anti-oxidant, etc.

Where a Chemical Safety Report is required, the Safety Data Sheet shall contain information on all the identified
uses relevant to the recipient of the Safety Data Sheet. This information shall be consistent with the identified
uses and exposure scenarios set out in the annex to the Safety Data Sheet.

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1.3. Company/undertaking identification

Identify the person responsible for placing the substance or preparation on the market within the Co mmunity,
importer or distributor. Give the full address and telephone number of this
whether it is the manufacturer,
person as well as the e-mail address of the competent person responsible for the Safety Data Sheet.

In addition, where this person is not located in the Member State where the substance or preparation is placed
on the market, give a full address and telephone number for the person responsible in that Member State, if
possible.

For registrants, the person identified shall be consistent with the information on the identity of the manufacturer
or importer provided in the registration.

1.4.

Emergency telephone

In addition to the above mentioned information, supply the emergency telephone number of the company and/
or relevant official advisory body (this may be the body responsible for receiving information relating to health,
which is referred to in Article 17 of Directive 1999/45/EC). Specify if this phone number is available only during
office hours.

2.

HAZARDS IDENTIFICATION

Give here the classification of the substance or preparation which arises from application of the classification
rules in Directives 67/548/EEC or 1999/45/EC. Indicate clearly and briefly the hazards the substance or prepara-
tion presents to man and the environment.

Distinguish clearly between preparations which are classified as dangerous and preparations which are not classi-
fied as dangerous according to Directive 1999/45/EC.

Describe the most important adverse physicochemical, human health and environmental effects and symptoms
relating to the uses and possible misuses of the substance or preparation that can reasonably be foreseen.

It may be necessary to mention other hazards, such as dustiness, cross-sensitisation, suffocation, freezing, high
potency for odour or taste or environmental effects such as hazards to soil-dwelling organisms, ozone depletion,
photochemical ozone creation potential etc., which do not result in classification but which may contribute to
the overall hazards of the material.

The information shown on the label shall be given under heading 15.

The classification of the substance shall be consistent with the classification provided to the classification and
labelling inventory according to Title XI.

3.

COMPOSITION/INFORMATION ON INGREDIENTS

The information given shall enable the recipient to identify readily the hazards of the components of the prepara-
tion. The hazards of the preparation itself shall be given under heading 2.

3.1.

3.2.

It is not necessary to give the full composition (nature of the ingredients and their concentration), although a
general description of the components and their concentrations can be helpful.

For a preparation classified as dangerous according to Directive 1999/45/EC, the following substances shall be
indicated, together with their concentration or concentration range in the preparation:

(a) substances presenting a health or environmental hazard within the meaning of Directive 67/548/EEC, if they

are present in concentrations equal to or greater than the lowest of:

— the applicable concentrations defined in the table of Article 3 (3) of Directive 1999/45/EC, or

— the concentration limits given in Annex I to Directive 67/548/EEC, or

— the concentration limits given in Part B of Annex II to Directive 1999/45/EC, or

— the concentration limits given in Part B of Annex III Directive 1999/45/EC, or

— the concentration limits given in Annex V to Directive 1999/45/EC, or

— the concentration limits given in an agreed entry in the classification and labelling inventory established

under Title XI of this Regulation;

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(b) substances for which there are Community workplace exposure limits, which are not already included under

point (a);

(c) substances that are persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in
accordance with the criteria set out in Annex XIII, if the concentration of an individual substance is equal to
or greater than 0,1 %.

3.3.

For a preparation not classified as dangerous according to Directive 1999/45/EC, the substances shall be indi-
cated, together with their concentration or concentration range, if they are present in an individual concentration
of either:

(a) ≥ 1 % by weight for non-gaseous preparations and ≥ 0,2 % by volume for gaseous preparations and

— the substances present a health or environmental hazard within the meaning of Directive 67/548/EEC (1);

or

— the substances are assigned Community workplace exposure limits;

or

(b) ≥ 0,1 % by weight and the substances are persistent, bioaccumulative and toxic or very persistent and very

bioaccumulative in accordance with the criteria set out in Annex XIII.

3.4.

from Articles 4 and 6 of Directive 67/548/EEC,

The classification (derived either
to
Directive 67/548/EEC or from an agreed entry in the classification and labelling inventory established under Title
XI of this Regulation) of the above substances shall be given, including the symbol letters and R phrases which
are assigned in accordance with their physicochemical, human health and environmental hazards. The R phrases
do not need to be written out in full here: reference shall be made to heading 16, where the full text of each rele-
vant R phrase shall be listed. If the substance does not meet the classification criteria, the reason for indicating
the substance in section 3 shall be described, such as ‘PBT-substance’ or ‘substance with a Community workplace
exposure limit’.

from Annex I

3.5.

The name and the Registration number, assigned under Article 20(1) of this Regulation, EINECS or ELINCs
number, if available, of the above substances shall be given in accordance with Directive 67/548/EEC. The CAS
number and IUPAC name (if available) may also be helpful. For substances listed by a generic name, according to
Article 15 of Directive 1999/45/EC or the footnote to Section 3.3 of this Annex, a precise chemical identifier is
not necessary.

3.6.

If, in accordance with the provisions of Article 15 of Directive 1999/45/EC or the footnote to Section 3.3 of this
Annex, the identity of certain substances is to be kept confidential, their chemical nature shall be described in
order to ensure safe handling. The name used shall be the same as that which derives from the above procedures.

4.

FIRST AID MEASURES

Describe the first-aid measures.

Specify first whether immediate medical attention is required.

The information on first aid shall be brief and easy to understand by the victim, bystanders and first-aiders. The
symptoms and effects shall be briefly summarised. The instructions shall indicate what is to be done on the spot
in the case of an accident and whether delayed effects can be expected after exposure.

Subdivide the information according to the different routes of exposure, i.e. inhalation, skin and eye contact and
ingestion, under different subheadings.

Indicate whether professional assistance by a doctor is needed or advisable.

For some substances or preparations it may be important to emphasise that special means to provide specific and
immediate treatment shall be available at the workplace.

5.

FIRE-FIGHTING MEASURES

Refer to requirements for fighting a fire caused by the substance or preparation, or arising in its vicinity by indi-
cating:

— suitable extinguishing media,

(1) Where the person responsible for placing the preparation on the market can demonstrate that the disclosure in the safety data sheet
of the chemical identity of a substance which is exclusively classified as irritant with the exception of those assigned R41 or irritant in
combination with one or more of the properties mentioned in point 2.3.4 of Article 10 of Directive 1999/45/EC, or harmful or
harmful
in combination with one or more of the properties mentioned in point 2.3.4 of Article 10 of Directive 1999/45/EC
presenting acute lethal effects alone, will put at risk the confidential nature of his intellectual property, he may, in accordance with the
provisions of Part B of Annex VI to Directive 1999/45/EC, refer to that substance either by means of a name that identifies the most
important functional chemical groups, or by means of an alternative name.

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— extinguishing media which shall not be used for safety reasons,

— special exposure hazards arising from the substance or preparation itself, combustion products, resulting

gases,

— special protective equipment for fire-fighters.

6.

ACCIDENTAL RELEASE MEASURES

Depending on the substance or preparation involved, information may be needed on:

personal precautions such as:

— removal of ignition sources, provision for sufficient ventilation/respiratory protection, control of dust, preven-

tion of skin and eye contact,

environmental precautions such as:

— keeping away from drains, surface- and ground-water and soil, possible need to alert the neighbourhood,

methods for cleaning up such as:

— use of absorbent material (e.g. sand, diatomaceous earth, acid binder, universal binder, sawdust, etc.), reduc-

tion of gases/fumes with water, dilution.

Also consider the need for indications such as: ‘never use, neutralise with …’.

Note

If appropriate refer to headings 8 and 13.

7.

HANDLING AND STORAGE

Note

Information in this section shall relate to the protection of human health, safety and the environment. It shall
assist the employer in devising suitable working procedures and organisational measures according to Article 5 of
Directive 98/24/EC.
Where a chemical safety report or a registration is required, the information in this section shall be consistent
with the information given, for the identified uses and exposure scenarios set out in the annex to the Safety Data
Sheet.

7.1. Handling

Specify precautions for safe handling including advice on technical measures such as:

— containment, local and general ventilation, measures to prevent aerosol and dust generation and fire, measures
required to protect the environment (e.g. use of filters or scrubbers on exhaust ventilation, use in a bunded
area, measures for collection and disposal of spillages, etc.) and any specific requirements or rules relating to
the substance or preparation (e.g. procedures or equipment which are prohibited or recommended) and if
possible give a brief description.

7.2.

Storage

Specify the conditions for safe storage such as:

— specific design for storage rooms or vessels (including retention walls and ventilation), incompatible materials,
conditions of storage (temperature and humidity limit/range, light, inert gas, etc.) special electrical equipment
and prevention of static electricity.

Give advice if relevant on quantity limits under storage conditions. In particular indicate any special requirements
such as the type of material used in the packaging/containers of the substance or preparation.

7.3.

Specific use(s)

For end products designed for specific use(s), recommendations shall refer to the identified use(s) and be detailed
and operational. If possible, reference shall be made to industry — or sector — specific approved guidance.

8.

EXPOSURE CONTROLS/PERSONAL PROTECTION

8.1.

Exposure limit values

Specify currently applicable specific control parameters including occupational exposure limit values and/or biolo-
gical limit values. Values shall be given for the Member State where the substance or preparation is placed on the
market. Give information on currently recommended monitoring procedures.

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Where a Chemical Safety Report is required, the relevant DNELs and PNECs for the substance shall be given for
the exposure scenarios set out in the annex to the Safety Data Sheet.

For preparations, it is useful to provide values for those constituent substances which are required to be listed in
the Safety Data Sheet according to heading 3.

8.2.

Exposure controls

For the purposes of this document exposure control means the full range of specific risk management measures
to be taken during use in order to minimise worker and environmental exposure. Where a chemical safety report
is required, a summary of the risk management measures shall be given in Section 8 of the Safety Data Sheet for
the identified uses set out in the Safety Data Sheet.

8.2.1. Occupational exposure controls

This information will be taken into account by the employer in carrying out an assessment of risk to the health
and safety of workers for the substance or preparation under Article 4 of Directive 98/24/EC, which requires, in
the order of priority:

— design of appropriate work processes and engineering controls, the use of adequate equipment and materials,

— the application of collective protection measures at source, such as adequate ventilation and appropriate orga-

nisational measures, and

— where exposure cannot be prevented by other means the use of individual protection measures, such as

personal protection equipment.

Therefore provide suitable and adequate information on these measures to enable a proper risk assessment to be
carried out under Article 4 of Directive 98/24/EC. This information shall complement that already given under
heading 7.1.

Where individual protection measures are needed, specify in detail which equipment will provide adequate and
suitable protection. Take into account Council Directive 89/686/EEC of 21 December 1989 on the approxima-
tion of the laws of the Member States relating to personal protective equipment (1) and make reference to the
appropriate CEN standards:

(a) R e s p i r a t o r y p r o t e c t i o n

For dangerous gases, vapours or dust, specify the type of protective equipment to be used, such as:

— self contained breathing apparatus, adequate masks and filters.

(b) H a n d p r o t e c t i o n

Specify clearly the type of gloves to be worn when handling the substance or preparation, including:

— the type of material,

— the breakthrough time of the glove material, with regard to the amount and duration of dermal exposure.

If necessary indicate any additional hand protection measures.

(c) E y e p r o t e c t i o n

Specify the type of eye protection equipment required such as:

— safety glasses, safety goggles, face shield.

(d) S k i n p r o t e c t i o n

If it is necessary to protect a part of the body other than the hands, specify the type and quality of protection
equipment required, such as:

— apron, boots and full protective suit.

If necessary, indicate any additional skin protection measures and specific hygiene measures.

(1) OJ L 399, 30.12.1989, p. 18. Directive as last amended by Regulation (EC) No 1882/2003.

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8.2.2. Environmental exposure controls

Specify the information required by the employer to fulfil his commitments under Community environmental
protection legislation.

Where a chemical safety report is required, a summary of the risk management measures that adequately control
exposure of the environment to the substance shall be given for the exposure scenarios set out in the annex to
the Safety Data Sheet.

9.

PHYSICAL AND CHEMICAL PROPERTIES

To enable proper control measures to be taken, provide all relevant information on the substance or preparation,
particularly the information listed under heading 9.2. The information in this section shall be consistent with the
information provided in a registration where one is required.

9.1. General information

Appearance

Indicate the physical state (solid, liquid, gas) and the colour of the substance or preparation as supplied.

Odour

If odour is perceptible, give a brief description of it.

9.2.

Important health, safety and environmental information

pH:

Indicate the pH of the substance or preparation as supplied or of an aqueous solution; in the latter case, indicate
the concentration.

Boiling point/boiling range

Flash point

Flammability (solid, gas)

Explosive properties

Oxidising properties

Vapour pressure

Relative density

Solubility

Water solubility

Partition coefficient: n-octanol/water

Viscosity

Vapour density

Evaporation rate

9.3. Other information

Indicate other important safety parameters, such as, miscibility, fat solubility (solvent — oil to be specified),
conductivity, melting point/melting range, gas group (useful for Directive 94/9/EC of the European Parliament
and the Council of 23 March 1994 on the approximation of the laws of the Member States concerning equip-
intended for use in potentially explosive atmospheres (1)), auto-ignition
ment and protective systems
temperature, etc.

Note 1

The above properties shall be determined in accordance with the specifications of Part A of Annex XI or any
other comparable method.

Note 2

For preparations, information shall normally be given on the properties of the preparation itself. However, if it is
stated that a particular hazard does not apply, clearly differentiate between cases where no information is avail-
able to the classifier, and cases where negative test results are available. If it is considered necessary to give infor-
mation about the properties of individual components, please indicate clearly what the data refers to.

(1) OJ L 100, 19.4.1994, p. 1. Directive as amended by Regulation (EC) No 1882/2003.

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10.

STABILITY AND REACTIVITY

State the stability of the substance or preparation and the possibility of hazardous reactions occurring under
certain conditions of use and also if released into the environment.

10.1. Conditions to avoid

List those conditions such as temperature, pressure, light, shock, etc., which may cause a dangerous reaction and
if possible give a brief description.

10.2. Materials to avoid

List materials such as water, air, acids, bases, oxidising agents or any other specific substance which may cause a
dangerous reaction and if possible give a brief description.

10.3. Hazardous decomposition products

List hazardous materials produced in dangerous amounts upon decomposition.

Note

Address specifically:

— the need for and the presence of stabilisers,

— the possibility of a hazardous exothermic reaction,

— safety significance, if any, of a change in physical appearance of the substance or preparation,

— hazardous decomposition products, if any, formed upon contact with water,

— possibility of degradation to unstable products.

11.

TOXICOLOGICAL INFORMATION

This section deals with the need for a concise but complete and comprehensible description of the various toxico-
logical (health) effects, which can arise if the user comes into contact with the substance or preparation.

The information shall include dangerous-to-health effects from exposure to the substance or preparation, based
on the conclusion from, for example, test data and experience. The information shall also include, where appro-
priate, delayed, immediate and chronic effects from short- and long-term exposure such as sensitisation, narcosis,
carcinogenicity, mutagenicity and reproductive toxicity (developmental toxicity and fertility). It shall also include
information on the different routes of exposure (inhalation, ingestion, skin and eye contact), and describe the
symptoms related to the physical, chemical and toxicological characteristics.

Taking account of the information already provided under heading 3, composition/information on ingredients, it
may be necessary to make reference to specific health effects of certain substances in the preparation.

The information in this section shall be consistent with the information provided for in a registration where
required and/or in a Chemical Safety Report where required and shall give information on the following groups
of potential effects:

— toxicokinetics, metabolism and distribution,

— acute effects (acute toxicity, irritation and corrosivity),

— sensitisation,

— repeated dose toxicity, and

— CMR effects (carcinogenity, mutagenicity and toxicity for reproduction).

For substances subject to registration, summaries of the information derived from the application of Annexes VII
to XI of this Regulation shall be given. The information shall also include the result of the comparison of the
available data with the criteria given in Directive 67/548/EEC for CMR, categories 1 and 2, following para-
graph 1.3.1 of Annex I of this Regulation.

12.

ECOLOGICAL INFORMATION

Describe the possible effects, behaviour and environmental fate of the substance or preparation in air, water and/
or soil. Where available, give relevant test data (e.g. LC50 fish ≤ 1 mg/l).

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The information in this section shall be consistent with the information provided for in a registration where
required and/or in a Chemical Safety Report where required.

Describe the most important characteristics likely to have an effect on the environment owing to the nature of
the substance or preparation and likely methods of use. Information of the same kind shall be supplied for
dangerous products arising from the degradation of substances and preparations. This may include the following:

12.1. Ecotoxicity

This shall include relevant available data on aquatic toxicity, both acute and chronic for fish, crustaceans, algae
and other aquatic plants. In addition, toxicity data on soil micro- and macro-organisms and other environmentally
relevant organisms, such as birds, bees and plants, shall be included when available. Where the substance or
preparation has inhibitory effects on the activity of micro-organisms, the possible impact on sewage treatment
plants shall be mentioned.

For substances subject to registration, summaries of the information derived from the application of Annexes VII
to XI shall be included.

12.2. Mobility

The potential of the substance or the appropriate constituents of a preparation (1), if released to the environment,
to transport to groundwater or far from the site of release.

Relevant data might include:

— known or predicted distribution to environmental compartments,

— surface tension,

— absorption/desorption.

For other physicochemical properties see heading 9.

12.3. Persistence and degradability

The potential of the substance or the appropriate constituents of a preparation (1) to degrade in relevant environ-
mental media, either through biodegradation or other processes such as oxidation or hydrolysis. Degradation half
lives shall be quoted where available. The potential of the substance or appropriate constituents of a prepara-
tion (1) to degrade in sewage treatment plants shall also be mentioned.

12.4. Bioaccumulative potential

The potential of the substance or the appropriate constituents of a preparation (1) to accumulate in biota and,
eventually, to pass through the food chain, with reference to the octanol-water partition coefficient (Kow) and
bioconcentration factor (BCF), if available.

12.5. Results of PBT assessment

Where a Chemical Safety Report is required, the results of the PBT assessment as set in the Chemical Safety
Report shall be given.

12.6. Other adverse effects

If available, include information on any other adverse effects on the environment, e.g. ozone depletion potential,
photochemical ozone creation potential, endocrine disrupting potential and/or global warming potential.

Remarks

Ensure that information relevant to the environment is provided under other headings of the Safety Data Sheet,
especially advice for controlled release, accidental release measures, transport and disposal considerations under
headings 6, 7, 13, 14 and 15.

13.

DISPOSAL CONSIDERATIONS

If the disposal of the substance or preparation (surplus or waste resulting from the foreseeable use) presents a
danger, a description of these residues and information on their safe handling shall be given.

(1) This information cannot be given for the preparation because it is substance specific. It should therefore be given, where available and
appropriate, for each constituent substance in the preparation which is required to be listed in the Safety Data Sheet according to the
rules under Section 3 of this Annex.

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Specify the appropriate methods of disposal of both the substance or preparation and any contaminated packa-
ging (incineration, recycling, landfilling, etc.)

Where a Chemical Safety Report is required, the information on the waste management measures that adequately
control exposure of humans and the environment to the substance shall be consistent with the exposure scenarios
set out in the annex to the Safety Data Sheet.

Note

Refer to any relevant Community provisions relating to waste. In their absence, it is useful to remind the user
that national or regional provisions may be in force.

14.

TRANSPORT INFORMATION

Indicate any special precautions which a user needs to be aware of or needs to comply with in connection with
transport or conveyance either within or outside his premises. Where relevant, provide information on the trans-
port classification for each of the modal regulations: IMDG (sea), ADR (Council Directive 94/55/EC of 21
November 1994 on the approximation of the laws of the Member States with regard to the transport of
dangerous goods by road (1)), RID (Council Directive 96/49/EC of 23 July 1996 on the approximation of the laws
of the Member States with regard to the transport of dangerous goods by rail (2)), ICAO/IATA (air). This might
include inter alia:

— UN number,

— class,

— proper shipping name,

— packing group,

— marine pollutant,

— other applicable information.

15.

REGULATORY INFORMATION

Give the health, safety and environmental information shown on the label according to Directives 67/548/EEC
and 1999/45/EC.

If the substance or preparation covered by this safety data sheet is the subject of specific provisions in relation to
protection of man or the environment at Community level (e.g. authorisations given under Title VII or restrictions
under Title VIII) these provisions shall, as far as is possible, be stated.

Also mention, where possible, the national
measures that may be relevant.

laws which implement these provisions and any other national

16.

OTHER INFORMATION

Indicate any other information which the supplier assesses as being of importance for the health and safety of the
user and for the protection of the environment, for example:

— list of relevant R phrases. Write out the full text of any R phrases referred to under headings 2 and 3 of the

Safety Data Sheet,

— training advice,

— recommended restrictions on use (i.e. non-statutory recommendations by supplier),

— further information (written references and/or technical contact point),

— sources of key data used to compile the Safety Data Sheet.

For a revised Safety Data Sheet, indicate clearly the information, which has been added, deleted or revised (unless
this has been indicated elsewhere).

(1) OJ L 319, 12.12.1994, p. 7. Directive as last amended by Commission Directive 2004/111/EC (OJ L 365, 10.12.2004, p. 25).
(2) OJ L 235, 17.9.1996, p. 25. Directive as last amended by Commission Directive 2004/110/EC (OJ L 365, 10.12.2004, p. 24).

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CRITERIA FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10 TONNES

ANNEX III

Criteria for substances registered between 1 and 10 tonnes, with reference to Article 12(1)(a) and (b):

(a) substances for which it is predicted (ie by the application of (Q)SARs or other evidence) that they are likely to meet
the criteria for category 1 or 2 classification for carcinogenicity, mutagenicity or reproductive toxicity or the criteria
in Annex XIII,

(b) substances:

(i) with dispersive or diffuse use(s) particularly where such substances are used in consumer preparations or incor-

porated into consumer articles; and

(ii) for which it is predicted (i.e. by application of (Q)SARs or other evidence) that they are likely to meet the classifi-

cation criteria for any human health or environmental effects endpoints under Directive 67/548/EEC.

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EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(a)

ANNEX IV

EINECS no

Name/Group

200-061-5

D-glucitol C6H14O6

200-066-2

Ascorbic acid C6H8O6

200-075-1

Glucose C6H12O6

200-294-2

L-lysine C6H14N2O2

200-312-9

Palmitic acid, pure C16H32O2

200-313-4

Stearic acid, pure C18H36O2

200-334-9

Sucrose, pure C12H22O11

200-405-4

α-tocopheryl acetate C31H52O3

200-432-1

DL-methionine C5H11NO2S

200-711-8

D-mannitol C6H14O6

201-771-8

1-sorbose C6H12O6

204-007-1

Oleic acid, pure C18H34O2

204-664-4

Glycerol stearate, pure C21H42O4

204-696-9

Carbon dioxide CO2

205-278-9

Calcium pantothenate, D-form C9H17NO5.1/2Ca

205-582-1

Lauric acid, pure C12H24O2

205-590-5

Potassium oleate C18H34O2K

205-756-7

DL-phenylalanine C9H11NO2

208-407-7

Sodium gluconate C6H12O7.Na

212-490-5

Sodium stearate, pure C18H36O2.Na

215-279-6

Limestone

A noncombustible solid characteristic of sedimentary rock.
consists primarily of calcium carbonate

It

215-665-4

Sorbitan oleate C24H44O6

216-472-8

Calcium distearate, pure C18H36O2.1/2Ca

231-147-0

Argon Ar

231-153-3

Carbon C

231-783-9

Nitrogen N2

231-791-2

Water, distilled, conductivity or of similar purity H2O

231-955-3

Graphite C

CAS no

50-70-4

50-81-7

50-99-7

56-87-1

57-10-3

57-11-4

57-50-1

58-95-7

59-51-8

69-65-8

87-79-6

112-80-1

123-94-4

124-38-9

137-08-6

143-07-7

143-18-0

150-30-1

527-07-1

822-16-2

1317-65-3

1338-43-8

1592-23-0

7440-37-1

7440-44-0

7727-37-9

7732-18-5

7782-42-5

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EINECS no

Name/Group

232-273-9

Sunflower oil

CAS no

8001-21-6

Extractives and their physically modified derivatives.
It consists
primarily of the glycerides of the fatty acids linoleic, and oleic.
(Helianthus annuus, Compositae).

232-274-4

Soybean oil

8001-22-7

Extractives and their physically modified derivatives.
It consists
primarily of the glycerides of the fatty acids linoleic, oleic, palmitic
and stearic (Soja hispida, Leguminosae).

232-276-5

Safflower oil

8001-23-8

Extractives and their physically modified derivatives.
It consists
primarily of the glycerides of the fatty acid linoleic (Carthamus tinc-
torius, Compositae).

232-278-6

Linseed oil

Extractives and their physically modified derivatives.
It consists
primarily of the glycerides of the fatty acids linoleic, linolenic and
oleic (Linum usitatissimum, Linaceae).

232-281-2

Corn oil

It consists
Extractives and their physically modified derivatives.
primarily of the glycerides of the fatty acids linoleic, oleic, palmitic
and stearic. (Zea mays, Gramineae).

232-293-8

Castor Oil

Extractives and their physically modified derivatives.
primarily of
communis, Euphorbiaceae).

It consists
the fatty acid ricinoleic (Ricinus

the glycerides of

232-299-0

Rape oil

Extractives and their physically modified derivatives.
primarily of the glycerides of the fatty acids erucic,
oleic (Brassica napus, Cruciferae).

It consists
linoleic and

232-307-2

Lecithins

The complex combination of diglycerides of fatty acids linked to
the choline ester of phosphoric acid.

8001-26-1

8001-30-7

8001-79-4

8002-13-9

8002-43-5

232-436-4

Syrups, hydrolyzed starch

8029-43-4

A complex combination obtained by the hydrolysis of cornstarch
by the action of acids or enzymes.
It consists primarily of d-
glucose, maltose and maltodextrins.

232-442-7

Tallow, hydrogenated

232-675-4

Dextrin

232-679-6

Starch

High-polymeric carbohydrate material usually derived form cereal
grains such as corn, wheat and sorghum, and from roots and tubers
such as potatoes and tapioca. Includes starch which has been prege-
latinised by heating in the presence of water.

232-940-4

Maltodextrin

234-328-2

Vitamin A

8030-12-4

9004-53-9

9005-25-8

9050-36-6

11103-57-4

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EINECS no

Name/Group

238-976-7

Sodium D-gluconate C6H12O7.xNa

248-027-9

D-glucitol monostearate C24H48O7

262-988-1

Fatty acids, coco, Me esters

262-989-7

Fatty acids, tallow, Me esters

263-060-9

Fatty acids, castor-oil

263-129-3

Fatty acids, tallow

265-995-8

Cellulose Pulp

266-925-9

Fatty acids, C12-18
This substance is identified by SDA Substance Name: C12-C18 alkyl
carboxylic acid and SDA Reporting Number: 16-005-00.

CAS no

14906-97-9

26836-47-5

61788-59-8

61788-61-2

61789-44-4

61790-37-2

65996-61-4

67701-01-3

266-928-5

Fatty acids C16-18
This substance is identified by SDA Substance Name: C16-C18 alkyl
carboxylic acid and SDA Reporting Number: 19-005-00.

67701-03-5

266-929-0

266-930-6

266-932-7

Fatty acids, C8-18 and C18-unsatd.
This substance is identified by SDA Substance Name: C8-C18 and C18
unsaturated alkyl carboxylic acid and SDA Reporting Number: 01-
005-00.

Fatty acids, C14-18 and C16-18-unsatd.
This substance is identified by SDA Substance Name: C14-C18 and
and SDA Reporting
C16-C18
carboxylic
unsaturated
Number: 04-005-00

alkyl

acid

Fatty acids, C16-C18 and C18-unsatd.
This substance is identified by SDA Substance Name: C16-C18 and C18
unsaturated alkyl carboxylic acid and SDA Reporting Number: 11-
005-00

67701-05-7

67701-06-8

67701-08-0

266-948-4

Glycerides, C16-18 and C18-unsatd.
This substance is identified by SDA Substance Name: C16-C18 and C18
unsaturated trialkyl glyceride and SDA Reporting Number: 11-001-00.

67701-30-8

267-007-0

Fatty acids, C14-18 and C16-18-unsatd., Me esters
This substance is identified by SDA Substance Name: C14-C18 and
ester and SDA
C16-C18 unsaturated alkyl
Reporting Number: 04-010-00.

carboxylic acid methyl

67762-26-9

267-013-3

Fatty acids, C6-12
This substance is identified by SDA Substance Name: C6-C12 alkyl
carboxylic acid and SDA Reporting Number: 13-005-00.

67762-36-1

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EINECS no

268-099-5

Name/Group

Fatty acids, C14-22 and C16-22 unsatd.
This substance is identified by SDA Substance Name: C14-C22 and
and SDA Reporting
C16-C22
carboxylic
unsaturated
Number: 07-005-00

alkyl

acid

268-616-4

Syrups, corn, dehydrated

269-657-0

Fatty acids, soya

269-658-6

Glycerides, tallow mono-, di- and tri-, hydrogenated

270-298-7

Fatty acids, C14-22

270-304-8

Fatty acids, linseed-oil

270-312-1

Glycerides, C16-18 and C18-unsatd. mono- and di-
This substance is identified by SDA Substance Name: C16-C18 and C18
unsaturated alkyl and C16-C18 and C18 unsaturated dialkyl glyceride and
SDA Reporting Number: 11-002-00.

288-123-8

Glycerides, C10-18

292-771-7

Fatty acids, C12-14

292-776-4

Fatty acids, C12-18 and C18-unsatd.

296-916-5

Fatty acids, rape-oil, erucic acid-low

CAS no

68002-85-7

68131-37-3

68308-53-2

68308-54-3

68424-37-3

68424-45-3

68424-61-3

85665-33-4

90990-10-6

90990-15-1

93165-31-2

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EXEMPTIONS FROM THE OBLIGATION TO REGISTER IN ACCORDANCE WITH ARTICLE 2(7)(b)

ANNEX V

1. Substances which result from a chemical reaction that occurs incidental to exposure of another substance or article

to environmental factors such as air, moisture, microbial organisms or sunlight.

2. Substances which result from a chemical reaction that occurs incidental to storage of another substance, preparation

or article.

3. Substances which result from a chemical reaction occurring upon end use of other substances, preparations or arti-

cles and which are not themselves manufactured, imported or placed on the market.

4. Substances which are not themselves manufactured, imported or placed on the market and which result from a

chemical reaction that occurs when:

(a) a stabiliser, colorant, flavouring agent, antioxidant, filler, solvent, carrier, surfactant, plasticiser, corrosion inhi-
bitor, antifoamer or defoamer, dispersant, precipitation inhibitor, desiccant, binder, emulsifier, de-emulsifier,
dewatering agent, agglomerating agent, adhesion promoter, flow modifier, pH neutraliser, sequesterant, coagulant,
flocculant, fire retardant, lubricant, chelating agent, or quality control reagent functions as intended; or

(b) a substance solely intended to provide a specific physicochemical characteristic functions as intended.

5. By-products, unless they are imported or placed on the market themselves.

6. Hydrates of a substance or hydrated ions, formed by association of a substance with water, provided that the

substance has been registered by the manufacturer or importer using this exemption.

7. The following substances which occur in nature, if they are not chemically modified.

Minerals, ores, ore concentrates, cement clinker, natural gas, liquefied petroleum gas, natural gas condensate, process
gases and components thereof, crude oil, coal, coke.

8. Substances occurring in nature other than those listed under paragraph 7, if they are not chemically modified, unless

they meet the criteria for classification as dangerous according to Directive 67/548/EEC.

9. Basic elemental substances for which hazards and risks are already well known:

hydrogen, oxygen, noble gases (argon, helium, neon, xenon), nitrogen.

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ANNEX VI

INFORMATION REQUIREMENTS REFERRED TO IN ARTICLE 10

GUIDANCE NOTE ON FULFILLING THE REQUIREMENTS OF ANNEXES VI TO XI

Annexes VI to XI specify the information that shall be submitted for registration and evaluation purposes according to
Articles 10, 12, 13, 39, 40 and 45. For the lowest tonnage level, the standard requirements are in Annex VII, and every
time a new tonnage level is reached, the requirements of the corresponding Annex have to be added. For each registra-
tion the precise information requirements will differ, according to tonnage, use and exposure. The Annexes shall thus be
considered as a whole, and in conjunction with the overall requirements of registration, evaluation and the duty of care.

STEP 1 — GATHER AND SHARE EXISTING INFORMATION

The registrant should gather all existing available test data on the substance to be registered, this would include a litera-
ture search for relevant information on the substance. Wherever practicable, registrations should be submitted jointly, in
accordance with Articles 11 or 19. This will enable test data to be shared, thereby avoiding unnecessary testing and
reducing costs. The registrant should also collect all other available and relevant information on the substance regardless
whether testing for a given endpoint is required or not at the specific tonnage level. This should include information
from alternative sources (e.g. from (Q)SARs, read-across from other substances, in vivo and in vitro testing, epidemiolo-
gical data) which may assist in identifying the presence or absence of hazardous properties of the substance and which
can in certain cases replace the results of animal tests.

In addition, information on exposure, use and risk management measures in accordance with Article 10 and this Annex
should be collected. Considering all this information together, the registrant will be able to determine the need to
generate further information.

STEP 2 — CONSIDER INFORMATION NEEDS

The registrant shall identify what information is required for the registration. First, the relevant Annex or Annexes to be
followed shall be identified, according to tonnage. These Annexes set out the standard information requirements, but
shall be considered in conjunction with Annex XI, which allows variation from the standard approach, where it can be
justified. In particular, information on exposure, use and risk management measures shall be considered at this stage in
order to determine the information needs for the substance.

STEP 3 — IDENTIFY INFORMATION GAPS

The registrant shall then compare the information needs for the substance with the information already available and
identify where there are gaps. It is important at this stage to ensure that the available data is relevant and has sufficient
quality to fulfil the requirements.

STEP 4 — GENERATE NEW DATA/PROPOSE TESTING STRATEGY

In some cases it will not be necessary to generate new data. However, where there is an information gap that needs to
be filled, new data shall be generated (Annexes VII and VIII), or a testing strategy shall be proposed (Annexes IX and X),
depending on the tonnage. New tests on vertebrates shall only be conducted or proposed as a last resort when all other
data sources have been exhausted.

In some cases, the rules set out in Annexes VII to XI may require certain tests to be undertaken earlier than or in addi-
tion to the standard requirements.

NOTES

Note 1: If it is not technically possible, or if it does not appear scientifically necessary to give information, the reasons
shall be clearly stated, in accordance with the relevant provisions.

Note 2: The registrant may wish to declare that certain information submitted in the registration dossier is commercially
sensitive and its disclosure might harm him commercially. If this is the case, he shall list the items and provide a justifi-
cation.

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INFORMATION REFERRED TO IN ARTICLE 10(a) (i) TO (v)

1.

GENERAL REGISTRANT INFORMATION

1.1.

Registrant

1.1.1. Name, address, telephone number, fax number and e-mail address

1.1.2. Contact person

1.1.3. Location of the registrant's production and own use site(s), as appropriate

1.2.

Joint submission of data

Articles 11 or 19 foresee that parts of the registration may be submitted by one manufacturer or importer on
behalf of other manufacturers or importers.

In this case, that manufacturer or importer shall identify the other manufacturer or importers specifying:

— their name, address, telephone number, fax number and e-mail address,

— parts of the present registration which apply to other manufacturers or importers.

Mention the number(s) given in this Annex or Annexes VII to X, as appropriate.

Any other manufacturers or importers shall identify the manufacturer/importer submitting on his behalf speci-
fying:

— his name, address, telephone number, fax number and e-mail address,

— parts of the registration which are submitted by those manufacturer(s) or importer(s).

Mention the number(s) given in this Annex or Annexes VII to X, as appropriate.

2.

IDENTIFICATION OF THE SUBSTANCE

For each substance, the information given in this section shall be sufficient to enable each substance to be identi-
fied. If it is not technically possible or if it does not appear scientifically necessary to give information on one or
more of the items below, the reasons shall be clearly stated.

2.1. Name or other identifier of each substance

2.1.1. Name(s) in the IUPAC nomenclature or other international chemical name(s)

2.1.2. Other names (usual name, trade name, abbreviation)

2.1.3. EINECS or ELINCs number (if available and appropriate)

2.1.4. CAS name and CAS number (if available)

2.1.5. Other identity code (if available)

2.2.

Information related to molecular and structural formula of each substance

2.2.1. Molecular and structural formula (including Smiles notation, if available)

2.2.2. Information on optical activity and typical ratio of (stereo) isomers (if applicable and appropriate)

2.2.3. Molecular weight or molecular weight range

2.3.

Composition of each substance

2.3.1. Degree of purity ( %)

2.3.2. Nature of impurities, including isomers and by-products

2.3.3. Percentage of (significant) main impurities

2.3.4. Nature and order of magnitude (… ppm, … %) of any additives (e.g. stabilising agents or inhibitors)

2.3.5. Spectral data (ultra-violet, infra-red, nuclear magnetic resonance or mass spectrum)

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2.3.6. High-pressure liquid chromatogram, gas chromatogram

2.3.7. Description of the analytical methods or the appropriate bibliographical references for the identification of the
substance and, where appropriate, for the identification of impurities and additives. This information shall be
sufficient to allow the methods to be reproduced.

3.

INFORMATION ON MANUFACTURE AND USE(S) OF THE SUBSTANCE(S)

3.1. Overall manufacture and/or imports in tonnes per manufacturer or importer per year in:

The calendar year of the registration (estimated quantity)

3.2.

In case of a manufacturer: Brief description of the technological process used in manufacture

Precise details of the process, particularly those of a commercially sensitive nature, are not required.

3.3. An indication of the tonnage used for his own use(s)

3.4.

Form (substance, preparation or article) and/or physical state under which the substance is made available to
downstream users. Concentration or concentration range of the substance in preparations made available to
downstream users and quantities of the substance in articles made available to downstream users.

3.5.

Brief general description of the identified use(s)

3.6.

Information on waste quantities and composition of waste resulting from production and identified uses

3.7. Uses advised against (see Safety Data Sheet heading 16)

Where applicable, an indication of the uses, which the registrant advises against and why (i.e. non-statutory
recommendations by supplier). This need not be an exhaustive list.

4.

CLASSIFICATION AND LABELLING

4.1.

The hazard classification of the substance(s), resulting from the application of Articles 4 and 6 of Directive
67/548/EEC;

In addition, for each entry, the reasons why no classification is given for an endpoint should be provided (i.e. if
data are lacking, inconclusive, or conclusive but not sufficient for classification);

4.2.

4.3.

The resulting hazard label for the substance(s), resulting from the application of Articles 23, 24 and 25 of Direc-
tive 67/548/EEC;

Specific concentration limits, where applicable, resulting from the application of Article 4(4) of Directive
67/548/EEC and Articles 4 to 7 of Directive 1999/45/EC.

5.

GUIDANCE ON SAFE USE CONCERNING

This information shall be consistent with that in the Safety Data Sheet, where such a Safety Data Sheet is required
according to Article 31.

5.1.

First-aid measures (Safety Data Sheet heading 4)

5.2.

Fire-fighting measures (Safety Data Sheet heading 5)

5.3. Accidental release measures (Safety Data Sheet heading 6)

5.4. Handling and Storage (Safety Data Sheet heading 7)

5.5.

Transport information (Safety Data Sheet heading 14)

Where a Chemical Safety Report is not required, the following additional information is required:

5.6.

Exposure Controls/Personal Protection (Safety Data Sheet heading 8)

5.7.

Stability and Reactivity (Safety Data Sheet heading 10)

5.8. Disposal considerations

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5.8.1. Disposal considerations (Safety Data Sheet heading 13)

5.8.2. Information on recycling and methods of disposal for industry

5.8.3. Information on recycling and methods of disposal for the public

6.

INFORMATION ON EXPOSURE FOR SUBSTANCES REGISTERED IN QUANTITIES BETWEEN 1 AND 10
TONNES PER YEAR PER MANUFATCURER OR IMPORTER

6.1. Main use category:

6.1.1.

(a) industrial use and/or

(b) professional use and/or

(c) consumer use

6.1.2. Specification for industrial and professional use:

(a) used in closed system and/or

(b) use resulting in inclusion into or onto matrix and/or

(c) non-dispersive use and/or

(d) dispersive use

6.2.

Significant route(s) of exposure:

6.2.1. Human exposure:

(a) oral and/or

(b) dermal and/or

(c) inhalatory

6.2.2. Environmental exposure:

(a) water and/or

(b) air and/or

(c) solid waste and/or

(d) soil

6.3.

Pattern of exposure:

(a) accidental/infrequent and/or

(b) occasional and/or

(c) continuous/frequent

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ANNEX VII

STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR IMPORTED IN
QUANTITIES OF 1 TONNE OR MORE

Column 1 of this Annex establishes the standard information required for:

(a) non-phase-in substances manufactured or imported in quantities of 1 to 10 tonnes;

(b) phase-in substances manufactured or imported in quantities of 1 to 10 tonnes and meeting the criteria in Annex III

in accordance with Article 12(1)(a) and (b); and

(c) substances manufactured or imported in quantities of 10 tonnes or more.

Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided.
For substances not meeting the criteria in Annex III only the physicochemical requirements as set out in section 7 of
this Annex are required.

Column 2 of this Annex lists specific rules according to which the required standard information may be omitted,
replaced by other information, provided at a different stage or adapted in another way. If the conditions are met under
which column 2 of this Annex allows adaptations, the registrant shall clearly state this fact and the reasons for each
adaptation under the appropriate headings in the registration dossier.

In addition to these specific rules, a registrant may adapt the required standard information set out in column 1 of this
Annex according to the general rules contained in Annex XI with the exception of section 3 on substance-tailored expo-
sure waiving. In this case as well, he shall clearly state the reasons for any decision to adapt the standard information
under the appropriate headings in the registration dossier referring to the appropriate specific rule(s) in column 2 or in
Annex XI (1).

Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data,
historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach)
shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be
avoided. Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.

When, for certain endpoints, information is not provided for other reasons than those mentioned in column 2 of this
Annex or in Annex XI, this fact and the reasons shall also be clearly stated.

7. INFORMATION ON THE PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCE

COLUMN 1
STANDARD INFORMATION
REQUIRED

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

7.1.

of

State
at 20 °C and 101,3 kPa

the

substance

7.2.

Melting/freezing point

7.2.

The study does not need to be conducted below a lower limit of -20 °C.

7.3.

Boiling point

7.3.

7.4.

Relative density

7.4.

The study does not need to be conducted:
— for gases; or
— for solids which either melt above 300 °C or decompose before boiling. In such cases the boiling

point under reduced pressure may be estimated or measured; or

— for substances which decompose before boiling (e.g. auto-oxidation, rearrangement, degradation,

decomposition, etc.).

The study does not need to be conducted if:
— the substance is only stable in solution in a particular solvent and the solution density is similar to
that of the solvent. In such cases, an indication of whether the solution density is higher or lower
than the solvent density is sufficient; or

— the substance is a gas. In this case, an estimation based on calculation shall be made from its mole-

cular weight and the Ideal Gas Laws.

(1) Conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test

methods as specified in Article 13(2) that are not repeated in column 2, also apply.

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COLUMN 1
STANDARD INFORMATION
REQUIRED

7.5.

Vapour pressure

7.5.

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

The study does not need to be conducted if the melting point is above 300 °C.
If the melting point is between 200 °C and 300 °C, a limit value based on measurement or a recog-
nised calculation method is sufficient.

7.6.

Surface tension

7.6.

The study need only be conducted if:
— based on structure, surface activity is expected or can be predicted; or
— surface activity is a desired property of the material.
If the water solubility is below 1 mg/l at 20 °C the test does not need to be conducted.

7.7.

Water solubility

7.7.

The study does not need to be conducted if:
— the substance is hydrolytically unstable at pH 4, 7 and 9 (half-life less than 12 hours); or
— the substance is readily oxidisable in water.
If the substance appears ‘insoluble’ in water, a limit test up to the detection limit of the analytical
method shall be performed.

7.8.

Partition
n-octanol/water

coefficient

7.8.

The study does not need to be conducted if the substance is inorganic. If the test cannot be performed
(e.g. the substance decomposes, has a high surface activity, reacts violently during the performance of
the test or does not dissolve in water or in octanol, or it is not possible to obtain a sufficiently pure
substance), a calculated value for log P as well as details of the calculation method shall be provided.

7.9.

Flash-point

7.9.

The study does not need to be conducted if:
— the substance is inorganic; or
— the substance only contains volatile organic components with flash-points above 100 °C for

aqueous solutions; or

— the estimated flash-point is above 200 °C; or
— the flash-point can be accurately predicted by interpolation from existing characterised materials.

7.10.

Flammability

7.10.

The study does not need to be conducted:
— if the substance is a solid which possesses explosive or pyrophoric properties. These properties

should always be considered before considering flammability; or

— for gases, if the concentration of the flammable gas in a mixture with inert gases is so low that,

when mixed with air, the concentration is all time below the lower limit; or

— for substances which spontaneously ignite when in contact with air.

7.11.

Explosive properties

7.11.

The study does not need to be conducted if:
— there are no chemical groups associated with explosive properties present in the molecule; or
— the substance contains chemical groups associated with explosive properties which include oxygen

and the calculated oxygen balance is less than –200; or

— the organic substance or a homogenous mixture of organic substances contains chemical groups
associated with explosive properties, but the exothermic decomposition energy is less than 500 J/g
and the onset of exothermic decomposition is below 500 °C; or

— for mixtures of inorganic oxidising substances (UN Division 5.1) with organic materials, the

concentration of the inorganic oxidising substance is:

— less than 15 %, by mass, if assigned to UN Packaging Group I (high hazard) or II (medium

hazard)

— less than 30 %, by mass, if assigned to UN Packaging Group III (low hazard).

Note: Neither a test for propagation of detonation nor a test for sensitivity to detonative shock is
required if the exothermic decomposition energy of organic materials is less than 800 J/g.

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COLUMN 1
STANDARD INFORMATION
REQUIRED

7.12.

Self-ignition temperature

7.12.

7.13.

Oxidising properties

7.13.

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

The study does not need to be conducted:
— if the substance is explosive or ignites spontaneously with air at room temperature; or
— for liquids non flammable in air, e.g. no flash point up to 200 °C; or
— for gases having no flammable range; or
— for solids, if the substance has a melting point < 160 °C, or if preliminary results exclude self-

heating of the substance up to 400 °C.

The study does not need to be conducted if:
— the substance is explosive; or
— the substance is highly flammable; or
— the substance is an organic peroxide; or
— the substance is incapable of reacting exothermically with combustible materials, for example on
the basis of the chemical structure (e.g. organic substances not containing oxygen or halogen
atoms and these elements are not chemically bonded to nitrogen or oxygen, or inorganic
substances not containing oxygen or halogen atoms).

The full test does not need to be conducted for solids if the preliminary test clearly indicates that the
test substance has oxidising properties.
Note that as there is no test method to determine the oxidising properties of gaseous mixtures, the
evaluation of these properties must be realised by an estimation method based on the comparison of
the oxidising potential of gases in a mixture with that of the oxidising potential of oxygen in air.

7.14.

Granulometry

7.14.

The study does not need to be conducted if the substance is marketed or used in a non solid or gran-
ular form.

8. TOXICOLOGICAL INFORMATION

COLUMN 1
STANDARD INFORMATION
REQUIRED

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

8.1.

Steps 3 and 4 do not need to be conducted if:
— the available information indicates that the criteria are met for classification as corrosive to the

skin or irritating to eyes; or

— the substance is flammable in air at room temperature; or
— the substance is classified as very toxic in contact with skin; or
— an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose

level (2 000 mg/kg body weight).

8.2.

Step 3 does not need to be conducted if:
— the available information indicates that the criteria are met for classification as corrosive to the

skin or irritating to eyes; or

— the substance is flammable in air at room temperature;

8.1.

8.2.

or

skin

irritation

Skin
corrosion
this
assessment of
The
endpoint
comprise
shall
the following consecutive
steps:
(1) an assessment of

the
available human and
animal data,

(2) an assessment of

the
acid or alkaline reserve,
(3) in vitro study for skin

corrosion,

(4) in vitro study for skin

irritation.

Eye irritation
this
assessment of
The
endpoint
comprise
shall
the following consecutive
steps:
(1) an assessment of

the
available human and
animal data,

(2) an assessment of

the
acid or alkaline reserve,
(3) in vitro study for eye

irritation.

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8.3.

COLUMN 1
STANDARD INFORMATION
REQUIRED

Skin sensitisation
this
assessment of
The
endpoint
comprise
shall
the following consecutive
steps:
(1) an assessment of

the
available
human,
animal and alternative
data,

(2) In vivo testing.

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

8.3.

Step 2 does not need to be conducted if:
— the available information indicates that the substance should be classified for skin sensitisation or

corrosivity; or

— the substance is a strong acid (pH < 2,0) or base (pH > 11,5); or
— the substance is flammable in air at room temperature.
The Murine Local Lymph Node Assay (LLNA) is the first-choice method for in vivo testing. Only in
exceptional circumstances should another test be used. Justification for the use of another test shall be
provided.

8.4.

Mutagenicity

8.4.

Further mutagenicity studies shall be considered in case of a positive result.

8.4.1.

vitro

In
study in bacteria

gene mutation

8.5.

Acute toxicity

8.5.

The study/ies do(es) not generally need to be conducted if:
— the substance is classified as corrosive to the skin.

8.5.1.

By oral route

The study need not be conducted if a study on acute toxicity by the inhalation route (8.5.2) is avail-
able.

9. ECOTOXICOLOGICAL INFORMATION

COLUMN 1
STANDARD INFORMATION
REQUIRED

9.1.

Aquatic toxicity

9.1.1.

Short-term toxicity testing
on invertebrates (preferred
species Daphnia)
The
may
registrant
consider long-term toxicity
short-
testing instead of
term.

9.1.2. Growth inhibition study
(algae

plants

aquatic
preferred)

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

9.1.1.

The study does not need to be conducted if:
— there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the
substance is highly insoluble in water or the substance is unlikely to cross biological membranes;
or

— a long-term aquatic toxicity study on invertebrates is available; or
— adequate information for environmental classification and labelling is available.
The long-term aquatic toxicity study on Daphnia (Annex IX, section 9.1.5) shall be considered if the
substance is poorly water soluble.

9.1.2.

The study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity
is unlikely to occur for instance if the substance is highly insoluble in water or the substance is unlikely
to cross biological membranes.

9.2.

Degradation

9.2.1.

Biotic

9.2.1.1. Ready biodegradability

9.2.1.1. The study does not need to be conducted if the substance is inorganic.

Any other relevant physicochemical, toxicological and ecotoxicological information that is available shall be provided.

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ANNEX VIII

ADDITIONAL STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR
IMPORTED IN QUANTITIES OF 10 TONNES OR MORE

Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in
quantities of 10 tonnes or more in accordance with Article 12(1)(c). Accordingly, the information required in column 1
of this Annex is additional to that required in column 1 of Annex VII. Any other relevant physicochemical, toxicological
and ecotoxicological information that is available shall be provided. Column 2 of this Annex lists specific rules according
to which the required standard information may be omitted, replaced by other information, provided at a different stage
or adapted in another way. If the conditions are met under which column 2 of this Annex allows adaptations, the regis-
trant shall clearly state this fact and the reasons for each adaptation under the appropriate headings in the registration
dossier.

In addition to these specific rules, a registrant may adapt the required standard information set out in column 1 of this
Annex according to the general rules contained in Annex XI. In this case as well, he shall clearly state the reasons for
any decision to adapt the standard information under the appropriate headings in the registration dossier referring to
the appropriate specific rule(s) in column 2 or in Annex XI (1).

Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data,
historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach)
shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be
avoided. Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.

When, for certain endpoints, information is not provided for other reasons than those mentioned in column 2 of this
Annex or in Annex XI, this fact and the reasons shall also be clearly stated.

8. TOXICOLOGICAL INFORMATION

COLUMN 1
STANDARD INFORMATION
REQUIRED

8.1.

Skin irritation

8.1.1.

In vivo skin irritation

8.1.1.

8.2.

Eye irritation

8.2.1.

In vivo eye irritation

8.2.1.

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

The study does not need to be conducted if:
— the substance is classified as corrosive to the skin or as a skin irritant; or
— the substance is a strong acid (pH < 2,0) or base (pH > 11,5); or
— the substance is flammable in air at room temperature; or
— the substance is classified as very toxic in contact with skin; or
— an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose

level (2 000 mg/kg body weight).

The study does not need to be conducted if:
— the substance is classified as irritating to eyes with risk of serious damage to eyes; or
— the substance is classified as corrosive to the skin and provided that the registrant classified the

substance as eye irritant; or

— the substance is a strong acid (pH < 2,0) or base (pH > 11,5); or
— the substance is flammable in air at room temperature.

8.4.

Mutagenicity

8.4.2.

In vitro cytogenicity study
in mammalian cells

8.4.2.

The study does not usually need to be conducted
— if adequate data from an in vivo cytogenicity test are available or
— the substance is known to be carcinogenic category 1 or 2 or mutagenic category 1, 2 or 3.

(1) Conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test

methods as specified in Article 13(2) that are not repeated in column 2, also apply.

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COLUMN 1
STANDARD INFORMATION
REQUIRED

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

8.4.3.

a negative

In vitro gene mutation
study in mammalian cells,
if
in
Annex VII, section 8.4.1.
section
and Annex VIII,
8.4.2.

result

8.4.3.

The study does not usually need to be conducted if adequate data from a reliable in vivo mammalian
gene mutation test are available.

8.4.

Appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the
genotoxicity studies in Annex VII or VIII.

8.5.

Acute toxicity

8.5.

The study/ies do(es) not generally need to be conducted if:
— the substance is classified as corrosive to the skin.
In addition to the oral route (8.5.1), for substances other than gases, the information mentioned under
8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will
depend on the nature of the substance and the likely route of human exposure. If there is only one
route of exposure, information for only that route need be provided.

8.5.2.

By inhalation

8.5.2.

Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into
account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles
or droplets of an inhalable size.

8.5.3.

By dermal route

8.5.3.

Testing by the dermal route is appropriate if:
(1) inhalation of the substance is unlikely; and
(2) skin contact in production and/or use is likely; and
(3) the physicochemical and toxicological properties suggest potential for a significant rate of absorp-

tion through the skin.

8.6.

Repeated dose toxicity

8.6.1.

Short-term repeated dose
toxicity study (28 days),
one
and
species, male
female, most appropriate
route
administration,
having regard to the likely
route of human exposure.

of

8.6.1.

The short-term toxicity study (28 days) does not need to be conducted if:
— a reliable sub-chronic (90 days) or chronic toxicity study is available, provided that an appropriate

species, dosage, solvent and route of administration were used; or

— where a substance undergoes immediate disintegration and there are sufficient data on the cleavage

products; or

— relevant human exposure can be excluded in accordance with Annex XI section 3.
The appropriate route shall be chosen on the following basis:

Testing by the dermal route is appropriate if:

(1) inhalation of the substance is unlikely; and
(2) skin contact in production and/or use is likely; and
(3) the physicochemical and toxicological properties suggest potential for a significant rate of absorp-

tion through the skin.

Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into
account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles
or droplets of an inhalable size.

The sub-chronic toxicity study (90 days) (Annex IX, section 8.6.2) shall be proposed by the registrant
if: the frequency and duration of human exposure indicates that a longer term study is appropriate;

and one of the following conditions is met:

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COLUMN 1
STANDARD INFORMATION
REQUIRED

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

— other available data indicate that the substance may have a dangerous property that cannot be

detected in a short-term toxicity study; or

— appropriately designed toxicokinetic studies reveal accumulation of the substance or its metabolites
in certain tissues or organs which would possibly remain undetected in a short-term toxicity study
but which are liable to result in adverse effects after prolonged exposure.

Further studies shall be proposed by the registrant or may be required by the Agency in accordance
with Article 39 or 40 in case of:

— failure to identify a NOAEL in the 28 or the 90 days study, unless the reason for the failure to

identify a NOAEL is absence of adverse toxic effects; or
— toxicity of particular concern (e.g. serious/severe effects); or
— indications of an effect for which the available evidence is inadequate for toxicological and/or risk
characterisation. In such cases it may also be more appropriate to perform specific toxicological
studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity); or

— the route of exposure used in the initial repeated dose study was inappropriate in relation to the

expected route of human exposure and route-to-route extrapolation cannot be made; or

— particular concern regarding exposure (e.g. use in consumer products leading to exposure levels

which are close to the dose levels at which toxicity to humans may be expected ); or

— effects shown in substances with a clear relationship in molecular structure with the substance

being studied, were not detected in the 28 or the 90 days study.

8.7.1.

This study does not need to be conducted if:
— the substance is known to be a genotoxic carcinogen and appropriate risk management measures

are implemented; or

— the substance is known to be a germ cell mutagen and appropriate risk management measures are

implemented; or

— relevant human exposure can be excluded in accordance with Annex XI section 3; or

— a pre-natal developmental toxicity study (section 8.7.2 of this Annex) or a two-generation repro-

ductive toxicity study (section 8.7.3 of this Annex) is available.

If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as
Repr Cat 1 or 2: R60, and the available data are adequate to support a robust risk assessment, then no
further testing for fertility will be necessary. However, testing for development toxicity must be consid-
ered.

If a substance is known to cause developmental toxicity, meeting the criteria for classification as Repr
Cat 1 or 2: R61, and the available data are adequate to support a robust risk assessment, then no
further testing for developmental toxicity will be necessary. However, testing for effects on fertility
must be considered.

In cases where there are serious concerns about the potential for adverse effects on fertility or develop-
ment, either a pre-natal developmental toxicity study (Annex IX, section 8.7.2) or a two-generation
reproductive toxicity study (Annex IX, section 8.7.3) may be proposed by the registrant instead of the
screening study.

8.7.

Reproductive toxicity

8.7.1.

is

Screening for reproductive/
developmental
toxicity,
one species (OECD 421 or
there
422),
no
if
evidence
from available
information on structurally
related
from
substances,
(Q)SAR estimates or from
in vitro methods that the
substance may be a devel-
opmental toxicant.

8.8.

Toxicokinetics

behaviour

8.8.1. Assessment of the toxicoki-
the
netic
substance
extent
that can be derived from
the relevant available infor-
mation

to the

of

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9. ECOTOXICOLOGICAL INFORMATION

COLUMN 1
STANDARD INFORMATION
REQUIRED

9.1.3.

Short-term toxicity testing
on fish: The registrant may
consider long-term toxicity
short-
testing instead of
term.

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

9.1.3.

The study does not need to be conducted if:
— there are mitigating factors indicating that aquatic toxicity is unlikely to occur, for instance if the
substance is highly insoluble in water or the substance is unlikely to cross biological membranes;
or

9.1.4. Activated sludge

respira-

9.1.4.

tion inhibition testing

9.2.

Degradation

9.2.

— a long-term aquatic toxicity study on fish is available.
Long-term aquatic toxicity testing as described in Annex IX shall be considered if the chemical safety
assessment according to Annex I indicates the need to investigate further effects on aquatic organisms.
The choice of the appropriate test(s) will depend on the results of the chemical safety assessment.

The long-term aquatic toxicity study on fish (Annex IX, section 9.1.6) shall be considered if the
substance is poorly water soluble.

The study does not need to be conducted if:
— there is no emission to a sewage treatment plant; or
— there are mitigating factors indicating that microbial toxicity is unlikely to occur, for instance the

substance is highly insoluble in water; or

— the substance is found to be readily biodegradable and the applied test concentrations are in the

range of concentrations that can be expected in the influent of a sewage treatment plant.

The study may be replaced by a nitrification inhibition test if available data show that the substance is
likely to be an inhibitor of microbial growth or function, in particular nitrifying bacteria.

Further degradation testing shall be considered if the chemical safety assessment according to Annex I
indicates the need to investigate further the degradation of the substance. The choice of the appropriate
test(s) will depend on the results of the chemical safety assessment.

9.2.2. Abiotic

9.2.2.1. Hydrolysis as a function of

pH.

9.2.2.1. The study does not need to be conducted if:
— the substance is readily biodegradable; or
— the substance is highly insoluble in water.

9.3.

Fate and behaviour in the
environment

9.3.1. Adsorption/desorption

9.3.1.

screening

The study does not need to be conducted if:
— based on the physicochemical properties the substance can be expected to have a low potential for

adsorption (e.g. the substance has a low octanol water partition coefficient); or

— the substance and its relevant degradation products decompose rapidly.

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ANNEX IX

ADDITIONAL STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR
IMPORTED IN QUANTITIES OF 100 TONNES OR MORE

At the level of this Annex, the registrant must submit a proposal and a time schedule for fulfilling the information
requirements of this Annex in accordance with Article 12(1)(d).

Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in
quantities of 100 tonnes or more in accordance with Article 12(1)(d). Accordingly, the information required in column 1
of this Annex is additional to that required in column 1 of Annexes VII and VIII. Any other relevant physicochemical,
toxicological and ecotoxicological information that is available shall be provided. Column 2 of this Annex lists specific
rules according to which the registrant may propose to omit the required standard information, replace it by other infor-
mation, provide it at a later stage or adapt it in another way. If the conditions are met under which column 2 of this
Annex allows an adaptation to be proposed, the registrant shall clearly state this fact and the reasons for proposing each
adaptation under the appropriate headings in the registration dossier.

In addition to these specific rules, a registrant may propose to adapt the required standard information set out in
column 1 of this Annex according to the general rules contained in Annex XI. In this case as well, he shall clearly state
the reasons for any decision to propose adaptations to the standard information under the appropriate headings in the
registration dossier referring to the appropriate specific rule(s) in column 2 or in Annex XI (1).

Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data,
historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach)
shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be
avoided. Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.

When, for certain endpoints, it is proposed not to provide information for other reasons than those mentioned in
column 2 of this Annex or in Annex XI, this fact and the reasons shall also be clearly stated.

7. INFORMATION ON THE PHYSICOCHEMICAL PROPERTIES OF THE SUBSTANCE

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

7.15.

The study does not need to be conducted if the substance is inorganic.

COLUMN 1
STANDARD INFORMATION
REQUIRED

7.15.

Stability in organic solvents
and identity of
relevant
degradation products
Only required if stability of
the substance is considered
to be critical.

7.16.

Dissociation constant

7.16.

The study does not need to be conducted if:
— the substance is hydrolytically unstable (half-life less than 12 hours) or is readily oxidisable in

water; or

— it is scientifically not possible to perform the test for instance if the analytical method is not sensi-

tive enough.

7.17.

Viscosity

(1) Conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test

methods as specified in Article 13(2) that are not repeated in column 2, also apply.

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8. TOXICOLOGICAL INFORMATION

COLUMN 1
STANDARD INFORMATION
REQUIRED

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

8.4.

If there is a positive result in any of the in vitro genotoxicity studies in Annex VII or VIII and there are
no results available from an in vivo study already, an appropriate in vivo somatic cell genotoxicity study
shall be proposed by the registrant.
If there is a positive result from an in vivo somatic cell study available, the potential for germ cell muta-
genicity should be considered on the basis of all available data, including toxicokinetic evidence. If no
clear conclusions about germ cell mutagenicity can be made, additional investigations shall be consid-
ered.

8.6.

Repeated dose toxicity

8.6.1.

of

Short-term repeated dose
toxicity study (28 days),
and
species, male
one
female, most appropriate
route
administration,
having regard to the likely
route of human exposure,
unless already provided as
part of Annex VIII require-
ments or if tests according
to section 8.6.2 of
this
Annex is proposed. In this
case, Section 3 of Annex XI
shall not apply.

8.6.2.

Sub-chronic toxicity study
(90-day),
species,
one
rodent, male and female,
most appropriate route of
administration,
having
regard to the likely route
of human exposure.

8.6.2.

The sub-chronic toxicity study (90 days) does not need to be conducted if:
— a reliable short-term toxicity study (28 days) is available showing severe toxicity effects according
to the criteria for classifying the substance as R48, for which the observed NOAEL-28 days, with
the application of an appropriate uncertainty factor, allows the extrapolation towards the NOAEL-
90 days for the same route of exposure; or

— a reliable chronic toxicity study is available, provided that an appropriate species and route of

administration were used; or

— a substance undergoes immediate disintegration and there are sufficient data on the cleavage

products (both for systemic effects and effects at the site of uptake); or

— the substance is unreactive, insoluble and not inhalable and there is no evidence of absorption and
no evidence of toxicity in a 28-day ‘limit test’, particularly if such a pattern is coupled with limited
human exposure.

The appropriate route shall be chosen on the following basis:

Testing by the dermal route is appropriate if:

(1) skin contact in production and/or use is likely; and
(2) the physicochemical properties suggest a significant rate of absorption through the skin; and
(3) one of the following conditions is met:

— toxicity is observed in the acute dermal toxicity test at lower doses than in the oral toxicity

test; or

— systemic effects or other evidence of absorption is observed in skin and/or eye irritation

studies; or

— in vitro tests indicate significant dermal absorption; or
— significant dermal

toxicity or dermal penetration is

recognised for

structurally-related

substances.

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COLUMN 1
STANDARD INFORMATION
REQUIRED

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

Testing by the inhalation route is appropriate if:

— exposure of humans via inhalation is likely taking into account the vapour pressure of the
substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

Further studies shall be proposed by the registrant or may be required by the Agency in accordance
with Articles 39 or 40 in case of:

— failure to identify a NOAEL in the 90 days study unless the reason for the failure to identify a

NOAEL is absence of adverse toxic effects; or

— toxicity of particular concern (e.g. serious/severe effects); or

— indications of an effect for which the available evidence is inadequate for toxicological and/or risk
characterisation. In such cases it may also be more appropriate to perform specific toxicological
studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity); or

— particular concern regarding exposure (e.g. use in consumer products leading to exposure levels

which are close to the dose levels at which toxicity to humans may be expected).

8.7.

Reproductive toxicity

8.7.

The studies do not need to be conducted if:

— the substance is known to be a genotoxic carcinogen and appropriate risk management measures

are implemented; or

— the substance is known to be a germ cell mutagen and appropriate risk management measures are

implemented; or

— the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests avail-
able), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant
routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive
method and absence of the substance and of metabolites of the substance in urine, bile or exhaled
air) and there is no or no significant human exposure.

If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as
Repr Cat 1 or 2: R60, and the available data are adequate to support a robust risk assessment, then no
further testing for fertility will be necessary. However, testing for development toxicity must be consid-
ered.

If a substance is known to cause developmental toxicity, meeting the criteria for classification as Repr
Cat 1 or 2: R61, and the available data are adequate to support a robust risk assessment, then no
further testing for developmental toxicity will be necessary. However, testing for effects on fertility
must be considered.

8.7.2.

The study shall be initially performed on one species. A decision on the need to perform a study at
this tonnage level or the next on a second species should be based on the outcome of the first test and
all other relevant available data.

8.7.2.

Pre-natal
developmental
toxicity study, one species,
most appropriate route of
administration,
having
regard to the likely route
of human exposure (B.31
of the Commission Regu-
lation on test methods as
specified in Article 13(2)
or OECD 414).

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COLUMN 1
STANDARD INFORMATION
REQUIRED

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

8.7.3.

The study shall be initially performed on one species. A decision on the need to perform a study at
this tonnage level or the next on a second species should be based on the outcome of the first test and
all other relevant available date.

8.7.3.

of

Two-generation reproduc-
study,
toxicity
tive
one
and
species, male
female, most appropriate
administration,
route
having regard to the likely
route of human exposure,
the 28-day or 90-day
if
adverse
study
reproductive
effects
organs or tissues.

indicates
on

9. ECOTOXICOLOGICAL INFORMATION

COLUMN 1
STANDARD INFORMATION
REQUIRED

9.1.

Aquatic toxicity

9.1.

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

Long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment
according to Annex I indicates the need to investigate further the effects on aquatic organisms. The
choice of the appropriate test(s) depends on the results of the chemical safety assessment.

9.1.5.

9.1.6.

Long-term toxicity testing
on invertebrates (preferred
species Daphnia),
(unless
already provided as part of
Annex VII requirements)

part

Long-term toxicity testing
already
(unless
on fish,
provided
of
as
Annex VIII requirements)
The information shall be
provided for one of
the
sections 9.1.6.1, 9.1.6.2 or
9.1.6.3.

9.1.6.2. Fish early-life stage (FELS)

toxicity test

9.1.6.2. Fish short-term toxicity test
on embryo and sac-fry
stages

9.1.6.3. Fish, juvenile growth test

9.2.

Degradation

9.2.

Further biotic degradation testing shall be proposed by the registrant if the chemical safety assessment
according to Annex I indicates the need to investigate further the degradation of the substance and its
degradation products. The choice of the appropriate test(s) depends on the results of the chemical
safety assessment and may include simulation testing in appropriate media (e.g. water, sediment or
soil).

9.2.1.

Biotic

9.2.1.2. Simulation testing on ulti-
in

degradation

mate
surface water

9.2.1.2. The study need not be conducted if:

— the substances is highly insoluble in water; or
— the substance is readily biodegradable.

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COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

9.2.1.3. The study need not be conducted:

— if the substance is readily biodegradable; or
— if direct and indirect exposure of soil is unlikely.

9.2.1.4. The study need not be conducted:

— if the substance is readily biodegradable; or
— if direct and indirect exposure of sediment is unlikely.

9.2.3. Unless the substance is readily biodegradable

COLUMN 1
STANDARD INFORMATION
REQUIRED

9.2.1.3. Soil simulation testing (for
substances with a high
potential for adsorption to
soil)

9.2.1.4. Sediment

simulation
testing (for substances with
a high potential for adsorp-
tion to sediment)

Identification of degrada-
tion products

Fate and behaviour in the
environment

9.2.3.

9.3.

9.3.2.

9.3.3.

Bioaccumulation in aquatic
species, preferably fish

9.3.2.

The study need not be conducted if:
— the substance has a low potential for bioaccumulation (for instance a log Kow < 3) and/or a low

on

Further
information
adsorption/desorption
depending on the results of
the
in
study
Annex VIII

required

potential to cross biological membranes; or

— direct and indirect exposure of the aquatic compartment is unlikely.

9.3.3.

The study need not be conducted if:
— based on the physicochemical properties the substance can be expected to have a low potential for

adsorption (e.g. the substance has a low octanol water partition coefficient); or

— the substance and its degradation products decompose rapidly.

9.4.

Effects on terrestrial organ-
isms

9.4.

These studies do not need to be conducted if direct and indirect exposure of the soil compartment is
unlikely.
In the absence of toxicity data for soil organisms, the equilibrium partitioning method may be applied
to assess the hazard to soil organisms. The choice of the appropriate tests depends on the outcome of
the chemical safety assessment.

In particular for substances that have a high potential to adsorb to soil or that are very persistent, the
registrant shall consider long-term toxicity testing instead of short-term.

9.4.1.

9.4.2.

9.4.3.

Short-term toxicity
invertebrates

to

Effects
organisms

on

soil micro-

Short-term toxicity
plants

to

10. METHODS OF DETECTION AND ANALYSIS

Description of the analytical methods shall be provided on request, for the relevant compartments for which studies
were performed using the analytical method concerned. If the analytical methods are not available this shall be justified.

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ANNEX X

ADDITIONAL STANDARD INFORMATION REQUIREMENTS FOR SUBSTANCES MANUFACTURED OR
IMPORTED IN QUANTITIES OF 1000 TONNES OR MORE

At the level of this Annex, the registrant must submit a proposal and a time schedule for fulfilling the information
requirements of this Annex in accordance with Article 12(1)(e).

Column 1 of this Annex establishes the standard information required for all substances manufactured or imported in
quantities of 1 000 tonnes or more in accordance with Article 12(1)(e). Accordingly, the information required in
column 1 of this Annex is additional to that required in column 1 of Annexes VII, VIII and IX. Any other relevant physi-
cochemical, toxicological and ecotoxicological information that is available shall be provided. Column 2 of this Annex
lists specific rules according to which the registrant may propose to omit the required standard information, replace it
by other information, provide it at a later stage or adapt it in another way. If the conditions are met under which
column 2 of this Annex allows an adaptation to be proposed, the registrant shall clearly state this fact and the reasons
for proposing each adaptation under the appropriate headings in the registration dossier.

In addition to these specific rules, a registrant may propose to adapt the required standard information set out in
column 1 of this Annex according to the general rules contained in Annex XI. In this case as well, he shall clearly state
the reasons for any decision to propose adaptations to the standard information under the appropriate headings in the
registration dossier referring to the appropriate specific rule(s) in column 2 or in Annex XI (1).

Before new tests are carried out to determine the properties listed in this Annex, all available in vitro data, in vivo data,
historical human data, data from valid (Q)SARs and data from structurally related substances (read-across approach)
shall be assessed first. In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall be
avoided. Prior to testing, further guidance on testing strategies should be consulted in addition to this Annex.

When, for certain endpoints, it is proposed not to provide information for other reasons than those mentioned in
column 2 of this Annex or in Annex XI, this fact and the reasons shall also be clearly stated.

8. TOXICOLOGICAL INFORMATION

COLUMN 1
STANDARD INFORMATION
REQUIRED

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

8.4.

If there is a positive result in any of the in vitro genotoxicity studies in Annexes VII or VIII, a second in
vivo somatic cell test may be necessary, depending on the quality and relevance of all the available data.
If there is a positive result from an in vivo somatic cell study available, the potential for germ cell muta-
genicity should be considered on the basis of all available data, including toxicokinetic evidence. If no
clear conclusions about germ cell mutagenicity can be made, additional investigations shall be consid-
ered.

8.6.3. A long-term repeated toxicity study (≥ 12 months) may be proposed by the registrant or required by the
Agency in accordance with Articles 39 or 40 if the frequency and duration of human exposure indicates
that a longer term study is appropriate and one of the following conditions is met:
— serious or severe toxicity effects of particular concern were observed in the 28-day or 90-day study
for which the available evidence is inadequate for toxicological evaluation or risk characterisation; or
— effects shown in substances with a clear relationship in molecular structure with the substance being

studied were not detected in the 28-day or 90-day study; or

— the substance may have a dangerous property that cannot be detected in a 90-day study.

(1) Conditions for not requiring a specific test that are set out in the appropriate test methods in the Commission Regulation on test

methods as specified in Article 13(2) that are not repeated in column 2, also apply.

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COLUMN 1
STANDARD INFORMATION
REQUIRED

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

8.6.4. Further studies shall be proposed by the registrant or may be required by the Agency in accordance with

Articles 39 or 40 in case of:
— toxicity of particular concern (e.g. serious/severe effects); or
— indications of an effect for which the available evidence is inadequate for toxicological evaluation
and/or risk characterisation. In such cases it may also be more appropriate to perform specific toxi-
cological studies that are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity); or
— particular concern regarding exposure (e.g. use in consumer products leading to exposure levels

which are close to the dose levels at which toxicity is observed).

8.7.

Reproductive toxicity

8.7.

The studies need not be conducted if:
— the substance is known to be a genotoxic carcinogen and appropriate risk management measures are

implemented; or

— the substance is known to be a germ cell mutagen and appropriate risk management measures are

implemented; or

— the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests avail-
able), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes
of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and
absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there
is no or no significant human exposure.

If a substance is known to have an adverse effect on fertility, meeting the criteria for classification as
Repr Cat 1 or 2: R60, and the available data are adequate to support a robust risk assessment, then no
further testing for fertility will be necessary. However, testing for development toxicity must be consid-
ered.

If a substance is known to cause developmental toxicity, meeting the criteria for classification as Repr
Cat 1 or 2: R61, and the available data are adequate to support a robust risk assessment, then no further
testing for developmental toxicity will be necessary. However, testing for effects on fertility must be
considered.

8.7.2. Developmental

toxicity
study, one
species, most
appropriate route of admin-
istration, having regard to
the likely route of human
exposure (OECD 414).

and

8.7.3. Two-generation reproductive
toxicity study, one species,
male
female, most
appropriate route of admin-
istration, having regard to
the likely route of human
already
unless
exposure,
provided as part of Annex IX
requirements

8.9.1. Carcinogenicity study

8.9.1. A carcinogenicity study may be proposed by the registrant or may be required by the Agency in accord-

ance with Articles 39 or 40 if:
— the substance has a widespread dispersive use or there is evidence of frequent or long-term human

exposure; and

— the substance is classified as mutagen category 3 or there is evidence from the repeated dose

study(ies) that the substance is able to induce hyperplasia and/or pre-neoplastic lesions.

If the substances is classified as mutagen category 1 or 2, the default presumption would be that a geno-
toxic mechanism for carcinogenicity is likely. In these cases, a carcinogenicity test will normally not be
required.

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9. ECOTOXICOLOGICAL INFORMATION

COLUMN 1
STANDARD INFORMATION
REQUIRED

9.2. Degradation

9.2.

9.2.1. Biotic

9.3.

Fate and behaviour
environment

in the

COLUMN 2
SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1

Further biotic degradation testing shall be proposed if the chemical safety assessment according to
Annex I indicates the need to investigate further the degradation of the substance and its degradation
products. The choice of the appropriate test(s) depends on the results of the chemical safety assessment
and may include simulation testing in appropriate media (e.g. water, sediment or soil).

9.3.4. Further information on the
environmental fate and beha-
viour of the substance and/
ore degradation products

9.3.4. Further testing shall be proposed by the registrant or may be required by the Agency in accordance with
Articles 39 or 40 if the chemical safety assessment according to Annex I indicates the need to investigate
further the fate and behaviour of the substance. The choice of the appropriate test(s) depends on the
results of the chemical safety assessment.

9.4.

Effects on terrestrial organ-
isms

9.4.

Long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assess-
ment according to Annex I indicates the need to investigate further the effects of the substance and/or
degradation products on terrestrial organisms. The choice of the appropriate test(s) depends on the
outcome of the chemical safety assessment.
These studies do not need to be conducted if direct and indirect exposure of the soil compartment is
unlikely.

9.4.4. Long-term toxicity testing on
invertebrates, unless already
provided as part of Annex IX
requirements.

9.4.6. Long-term toxicity testing on
plants,
already
unless
provided as part of Annex IX
requirements.

9.5.1. Long-term toxicity to sedi-

ment organisms

9.5.1. Long-term toxicity testing shall be proposed by the registrant if the results of the chemical safety assess-
ment indicates the need to investigate further the effects of the substance and/or relevant degradation
products on sediment organisms. The choice of the appropriate test(s) depends on the results of the
chemical safety assessment.

9.6.1. Long-term or
toxicity to birds

reproductive

9.6.1. Any need for testing should be carefully considered taking into account the large mammalian dataset

that is usually available at this tonnage level.

10. METHODS OF DETECTION AND ANALYSIS

Description of the analytical methods shall be provided on request, for the relevant compartments for which studies
were performed using the analytical method concerned. If the analytical methods are not available this shall be justified.

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ANNEX XI

GENERAL RULES FOR ADAPTATION OF THE STANDARD TESTING REGIME SET OUT IN ANNEXES VII
TO X

Annexes VII to X set out the information requirements for all substances manufactured or imported in quantities of:

— 1 tonne or more in accordance with Article 12(1)(a),

— 10 tonnes or more in accordance with Article 12(1)(c),

— 100 tonnes or more in accordance with Article 12(1)(d), and

— 1 000 tonnes or more in accordance with Article 12(1)(e).

In addition to the specific rules set out in Column 2 of Annexes VII to X, a registrant may adapt the standard testing
regime in accordance with the general rules set out in Section 1 of this Annex. Under evaluation competent authorities
of evaluating Member States may assess these adaptations to the standard testing regime.

1.

TESTING DOES NOT APPEAR SCIENTIFICALLY NECESSARY

1.1. Use of existing data

1.1.1. Data on physical-chemical properties from experiments not carried out according to GLP or the test methods referred to in

Article 13(2)

Data shall be considered to be equivalent to data generated by the corresponding test methods referred to in
Article 13(2) if the following conditions are met:

1) adequacy for the purpose of classification and labelling and/or risk assessment;

2) sufficient documentation is provided to assess the adequacy of the study; and

3) the data are valid for the endpoint being investigated and the study is performed using an acceptable level of

quality assurance.

1.1.2. Data on human health and environmental properties from experiments not carried out according to GLP or the test methods

referred to in Article 13(2)

Data shall be considered to be equivalent to data generated by the corresponding test methods referred to in
Article 13(2) if the following conditions are met:

1) adequacy for the purpose of classification and labelling and/or risk assessment;

2) adequate and reliable coverage of the key parameters foreseen to be investigated in the corresponding test

methods referred to in Article 13(2);

3) exposure duration comparable to or longer than the corresponding test methods referred to in Article 13(2) if

exposure duration is a relevant parameter; and

4) adequate and reliable documentation of the study is provided.

1.1.3. Historical human data

Historical human data, such as epidemiological studies on exposed populations, accidental or occupational expo-
sure data and clinical studies, shall be considered.

The strength of the data for a specific human health effect depends, among other things, on the type of analysis
and on the parameters covered and on the magnitude and specificity of the response and consequently the
predictability of the effect. Criteria for assessing the adequacy of the data include:

1) the proper selection and characterisation of the exposed and control groups;

2) adequate characterisation of exposure;

3) sufficient length of follow-up for disease occurrence;

4) valid method for observing an effect;

5) proper consideration of bias and confounding factors; and

6) a reasonable statistical reliability to justify the conclusion.

In all cases adequate and reliable documentation shall be provided.

1.2. Weight of evidence

There may be sufficient weight of evidence from several
independent sources of information leading to the
assumption/conclusion that a substance has or has not a particular dangerous property, while the information
from each single source alone is regarded insufficient to support this notion.

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There may be sufficient weight of evidence from the use of newly developed test methods, not yet included in the
test methods referred to in Article 13(2) or from an international test method recognised by the Commission or
the Agency as being equivalent, leading to the conclusion that a substance has or has not a particular dangerous
property.

Where sufficient weight of evidence for the presence or absence of a particular dangerous property is available:

— further testing on vertebrate animals for that property shall be omitted,

— further testing not involving vertebrate animals may be omitted.

In all cases adequate and reliable documentation shall be provided.

1.3. Qualitative or Quantitative structure-activity relationship ((Q)SAR)

Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indi-
cate the presence or absence of a certain dangerous property. Results of (Q)SARs may be used instead of testing
when the following conditions are met:

— results are derived from a (Q)SAR model whose scientific validity has been established,

— the substance falls within the applicability domain of the (Q)SAR model,

— results are adequate for the purpose of classification and labelling and/or risk assessment, and

— adequate and reliable documentation of the applied method is provided.

The Agency in collaboration with the Commission, Member States and interested parties shall develop and
provide guidance in assessing which (Q)SARs will meet these conditions and provide examples.

1.4.

In vitro methods

Results obtained from suitable in vitro methods may indicate the presence of a certain dangerous property or may
be important in relation to a mechanistic understanding, which may be important for the assessment. In this
context, ‘suitable’ means sufficiently well developed according to internationally agreed test development criteria
(e.g. the European Centre for the Validation of Alternative Methods (ECVAM)) criteria for the entry of a test into
the prevalidation process). Depending on the potential risk, immediate confirmation requiring testing beyond the
information foreseen in Annexes VII or VIII or proposed confirmation requiring testing beyond the information
foreseen in Annexes IX or X for the respective tonnage level may be necessary.

If the results obtained from the use of such in vitro methods do not indicate a certain dangerous property, the
relevant test shall nevertheless be carried out at the appropriate tonnage level to confirm the negative result,
unless testing is not required in accordance with Annexes VII to X or the other rules in this Annex.

Such confirmation may be waived, if the following conditions are met:

1) results are derived from an in vitro method whose scientific validity has been established by a validation

study, according to internationally agreed validation principles;

2) results are adequate for the purpose of classification and labelling and/or risk assessment; and

3) adequate and reliable documentation of the applied method is provided.

1.5. Grouping of substances and read-across approach

Substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow
a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances.
Application of the group concept requires that physicochemical properties, human health effects and environ-
mental effects or environmental fate may be predicted from data for reference substance(s) within the group by
interpolation to other substances in the group (read-across approach). This avoids the need to test every substance
for every endpoint.

The similarities may be based on:

1) a common functional group;

2) the common precursors and/or the likelihood of common breakdown products via physical and biological

processes, which result in structurally similar chemicals; or

3) a constant pattern in the changing of the potency of the properties across the category.

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If the group concept is applied, substances shall be classified and labelled on this basis.

In all cases results should:

— be adequate for the purpose of classification and labelling and/or risk assessment,

— have adequate and reliable coverage of the key parameters addressed in the corresponding test method

referred to in Article 13(2),

— cover an exposure duration comparable to or longer than the corresponding test method referred to in

Article 13(2) if exposure duration is a relevant parameter, and

— adequate and reliable documentation of the applied method shall be provided.

2.

TESTING IS TECHNICALLY NOT POSSIBLE

Testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a conse-
quence of the properties of the substance: e.g. very volatile, highly reactive or unstable substances cannot be
used, mixing of the substance with water may cause danger of fire or explosion or the radio-labelling of the
substance required in certain studies may not be possible. The guidance given in the test methods referred to in
Article 13(2), more specifically on the technical limitations of a specific method, shall always be respected.

3.

SUBSTANCE-TAILORED EXPOSURE-DRIVEN TESTING

3.1.

3.2.

Testing in accordance with sections 8.6 and 8.7 of Annex VIII, Annex IX and Annex X may be omitted, based on
the exposure scenario(s) developed in the Chemical Safety Report.

In all cases, adequate justification and documentation shall be provided. The justification shall be based on an
exposure assessment in accordance with section 5 of Annex I and be consistent with the criteria adopted pursuant
to section 3.3, and the specific conditions of use must be communicated through the chemical supply chain in
accordance with Articles 31 or 32.

3.3.

The Commission shall adopt criteria defining what constitutes adequate justification under Section 2 in accord-
ance with the procedure referred to inArticle 132(3) by … (*).

(*) 18 months after entry into force of this Regulation.

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GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL
SAFETY REPORTS

ANNEX XII

INTRODUCTION

The purpose of this Annex is to set out how downstream users are to assess and document that the risks arising from
the substance(s) they use are adequately controlled during their use for a use not covered by the Safety Data Sheet
supplied to them and that other users further down the supply chain can adequately control the risks. The assessment
shall cover the life-cycle of the substance, from its receipt by the downstream user, for his own uses and for his identi-
fied uses further down the supply chain. The assessment shall consider the use of the substance on its own, in a prepara-
tion or in an article.

In carrying out the chemical safety assessment and producing the Chemical Safety Report, the downstream user shall
take account of information received from the supplier of the chemical in accordance with Article 31 and 32 of this
Regulation. Where available and appropriate, an assessment carried out under Community legislation, (e.g. risk assess-
ments completed under Regulation (EEC) No 793/93) shall be taken into account in the chemical safety assessment and
be reflected in the Chemical Safety Report. Deviations from such assessments shall be justified. Assessments carried out
under other international and national programmes may also be taken into account.

The process which the downstream user goes through in carrying out the chemical safety assessment and in producing
his Chemical Safety Report, involves three steps:

STEP 1: DEVELOPMENT OF EXPOSURE SCENARIO(S)

The downstream user shall develop exposure scenarios for uses not covered in a Safety Data Sheet supplied to him in
accordance with Section 5 of Annex I.

STEP 2: IF NECESSARY, A REFINEMENT OF THE HAZARD ASSESSMENT BY THE SUPPLIER

If the downstream user considers the hazard and PBT assessments reported in the Safety Data Sheet supplied to him to
be appropriate, then no further hazard assessment or PBT and vPvB assessment is necessary. In this case he shall use the
relevant information reported by the supplier for the risk characterisation. This shall be stated in the Chemical Safety
Report.

If the downstream user considers the assessments reported in the Safety Data Sheet supplied to him to be inappropriate,
then he shall carry out the relevant assessments in accordance with Sections 1 to 4 of Annex I as appropriate to him.

In those cases where the downstream user considers that information in addition to that provided by the supplier is
necessary for producing his Chemical Safety Report the downstream user shall gather this information. Where this infor-
mation can only be obtained by testing on vertebrate animals, he shall submit a proposal for a testing strategy to the
Agency in accordance with Article 37. He shall explain why he considers that additional information is necessary. While
waiting for results of further testing, he shall record in his chemical safety report the risk management measures
intended to manage the risks being explored that he has put in place.

On completion of any additional testing, the downstream user shall revise the Chemical Safety Report, and his Safety
Data Sheet if he is required to prepare one, as appropriate.

STEP 3: RISK CHARACTERISATION

A risk characterisation shall be carried out for each new exposure scenario as prescribed in Section 6 of Annex I. The
risk characterisation shall be presented under the relevant heading of the Chemical Safety Report and summarised in the
Safety Data Sheet under the relevant heading(s).

When generating an exposure scenario it will be necessary to make initial assumptions about the operating conditions
and risk managements measures. If the initial assumptions lead to a risk characterisation indicating inadequate protection
of human health and the environment, then it shall be necessary to carry out an iterative process with amendment of
one or a number of factors until adequate control can be demonstrated. This may require the generation of additional
hazard or exposure information or appropriate alteration of the process, operating conditions or risk management
measures. Therefore, iterations may be made between on the one hand developing and revising an (initial) exposure
scenario, which includes developing and implementing risk management measures, and on the other hand generating
further information to produce the definitive exposure scenario. The purpose of generating further information is to
establish a more precise risk characterisation, based on a refined hazard assessment and/or exposure assessment.

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The downstream user shall produce a Chemical Safety Report detailing his chemical safety assessment using part B,
Sections 9 and 10, of the format set out in Section 7 of Annex I and the other sections of this format, if appropriate.

Part A of the Chemical Safety Report shall include a declaration that the risk management measures outlined in the rele-
vant exposure scenarios are implemented by the downstream user for his own uses and that the risk management
measures outlined in the exposure scenarios for the identified uses are communicated down the supply chain.

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ANNEX XIII

CRITERIA FOR THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES,
AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES

This Annex lays down the criteria for the identification of:

(i) persistent, bioaccumulative and toxic substances (PBT-substances), and

(ii) very persistent and very bioaccumulative substances (vPvB-substances).

A substance is identified as a PBT substance if it fulfils the criteria in Sections 1.1, 1.2 and 1.3. A substance is identified
as a vPvB substance if it fulfils the criteria in Sections 2.1 and 2.2. This annex shall not apply to inorganic substances,
but shall apply to organo-metals.

1.

PBT-SUBSTANCES

A substance that fulfils all three of the criteria of the sections below is a PBT substance.

1.1. Persistence

A substance fulfils the persistence criterion (P-) when:

— the half-life in marine water is higher than 60 days, or

— the half-life in fresh- or estuarine water is higher than 40 days, or

— the half-life in marine sediment is higher than 180 days, or

— the half-life in fresh- or estuarine water sediment is higher than 120 days, or

— the half-life in soil is higher than 120 days.

The assessment of the persistency in the environment shall be based on available half-life data collected under the
adequate conditions, which shall be described by the registrant.

1.2. Bioaccumulation

A substance fulfils the bioaccumulation criterion (B-) when:

— the bioconcentration factor (BCF) is higher than 2 000.

The assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species. Data
from freshwater as well as marine water species can be used.

1.3. Toxicity

A substance fulfils the toxicity criterion (T-) when:

— the long-term no-observed effect concentration (Noec) for marine or freshwater organisms is less than 0,01 mg/

l, or

— the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduc-

tion (category 1, 2, or 3), or

— there is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to

Directive 67/548/EEC.

2.

vPvB — SUBSTANCES

A substance that fulfils the criteria of the sections below is a vPvB substance.

2.1. Persistence

A substance fulfils the very persistence criterion (vP-) when:

— the half-life in marine, fresh- or estuarine water is higher than 60 days, or

— the half-life in marine, fresh- or estuarine water sediment is higher than 180 days, or

— the half-life in soil is higher than 180.

2.2. Bioaccumulation

A substance fulfils the very bioaccumulative criterion (vB-) when:

— the bioconcentration factor is greater than 5 000.

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ANNEX XIV

LIST OF SUBSTANCES SUBJECT TO AUTHORISATION

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ANNEX XV

DOSSIERS

I.

INTRODUCTION AND GENERAL PROVISIONS

This Annex lays down general principles for preparing dossiers to propose and justify:

— harmonised classification and labelling of CMRs, respiratory sensitisers and other effects,

— the identification of PBTs, vPvBs, or a substance of equivalent concern,

— restrictions of the manufacture, placing on the market or use of a substance within the Community.

The relevant parts of Annex I shall be used for the methodology and format of any dossier according to this Annex.

For all dossiers any relevant information from registration dossiers shall be considered and other available informa-
tion may be used. For hazard information which has not been previously submitted to the Agency, a robust study
summary shall be included in the dossier.

II. CONTENT OF DOSSIERS

1. Dossier for harmonised classification and labelling for CMRs, respiratory sensitisers and other effects

Proposal

The proposal shall include the identity of the substance(s) concerned and the harmonised classification and labelling
proposed.

Justification

A comparison of the available information with the criteria for CMRs, respiratory sensitisers and other effects on a
case by case basis in Directive 67/548/EEC according to the relevant parts of Section 1 of Annex I shall be completed
and documented in the format set out in Part B of the Chemical Safety Report in Annex I.

Justification for other effects at Community Level

Justification shall be provided that there is a need for action demonstrated at Community Level

2. Dossier for the identification of a substance as a CMR, PBT, vPvB or a substance of equivalent concern

according to Article 58

Proposal

The proposal shall include the identity of substance(s) concerned and whether it is proposed to be identified as a
CMR according to Article 56(a), (b) or (c), a PBT according to Article 56(d), a vPvB according to Article 56(e), or a
substance of equivalent concern according to Article 56(f).

Justification

A comparison of the available information with the criteria in Annex XIII for PBT according to Article 56(d), and
vPvBs according to Article 56(e), or an assessment of the hazards and a comparison with Article 56(f), according to
the relevant parts of Section 1 to 4 of Annex I shall be completed. This shall be documented in the format set out in
Part B of the Chemical Safety Report in Annex I.

Information on exposures, alternative substances and risks

The available use and exposure information and information on alternative substances and techniques shall be
provided.

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3. Dossiers for restrictions proposal

Proposal

The proposal shall include the identity of the substance and the restriction(s) proposed for the manufacture, placing
on the market or use(s) and a summary of the justification.

Information on hazard and risk

The risks to be addressed with the restriction shall be described based on an assessment of the hazard and risks
according to the relevant parts of Annex I and shall be documented in the format set out in Part B of that Annex for
the Chemical Safety Report.

Evidence shall be provided that implemented risk management measures (including those identified in registrations
under Articles 10 to 14) are not sufficient.

Information on alternatives

Available information on alternative substances and techniques shall be provided, including:

— information on the risks to human health and the environment related to the manufacture or use of the alterna-

tives,

— availability, including the time scale,

— technical and economical feasibility.

Justification for Restrictions at Community Level

Justification shall be provided that:

— action is required on a Community-wide basis,

— a restriction is the most appropriate Community wide measure which shall be assessed using the following

criteria:

(i) effectiveness: the restriction must be targeted to the effects or exposures that cause the risks identified,
capable of reducing these risks to an acceptable level within a reasonable period of time and proportional to
the risk;

(ii) practicality: the restriction must be implementable, enforceable and manageable;

(iii) monitorability: it must be possible to monitor the result of the implementation of the proposed restriction.

Socio-economic assessment

The socio-economic impacts of the proposed restriction may be analysed with reference to Annex XVI. To this end,
the net benefits to human health and the environment of the proposed restriction may be compared to its net costs
to manufacturers, importers, downstream users, distributors, consumers and society as a whole.

Information on stakeholder consultation

Information on any consultation of stakeholders and how their views have been taken into account shall be included
in the dossier.

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ANNEX XVI

SOCIO-ECONOMIC ANALYSIS

This Annex outlines the information that may be addressed by those submitting a socio-economic analysis (SEA) with
an application for authorisation, as specified in Article 61(5)(a), or in connection with a proposed restriction, as specified
in Article 68(6)(b).

The Agency shall prepare guidance for the preparation of SEAs. SEAs, or contributions to them, shall be submitted in
the format specified by the Agency in accordance with Article 110.

However, the level of detail and scope of the SEA, or contributions to them, shall be the responsibility of the applicant
for authorisation, or, in the case of a proposed restriction, the interested party. The information provided can address
the socio-economic impacts at any level.

An SEA may include the following elements:

— Impact of a granted or refused authorisation on the applicant(s), or, in the case of a proposed restriction, the impact
on industry (e.g. manufacturers and importers). The impact on all other actors in the supply chain, downstream
users and associated businesses in terms of commercial consequences such as impact on investment, research and
development, innovation, one-off and operating costs (e.g. compliance, transitional arrangements, changes to existing
processes, reporting and monitoring systems, installation of new technology, etc.) taking into account general trends
in the market and technology.

— Impacts of a granted or refused authorisation, or a proposed restriction, on consumers. For example, product prices,
changes in composition or quality or performance of products, availability of products, consumer choice, as well as
effects on human health and the environment to the extent that these affect consumers.

— Social implications of a granted or refused authorisation, or a proposed restriction. For example job security and

employment.

— Availability, suitability, and technical feasibility of alternative substances and/or technologies, and economic conse-
quences thereof, and information on the rates of, and potential for, technological change in the sector(s) concerned.
In the case of an application for authorisation, the social and/or economic impacts of using any available alternatives
identified in Article 61(5)(b).

— Wider implications on trade, competition and economic development (in particular for SMEs and in relation to third
countries) of a granted or refused authorisation, or a proposed restriction. This may include consideration of local,
regional, national or international aspects.

— In the case of a proposed restriction, proposals for other regulatory or non-regulatory measures that could meet the
aim of the proposed restriction (this shall take account of existing legislation). This should include an assessment of
the effectiveness and the costs linked to alternative risk management measures.

— In the case of a proposed restriction or refused authorisation, the benefits for human health and the environment as
well as the social and economic benefits of the proposed restriction. For example, worker health, environmental
performance and the distribution of these benefits, for example, geographically, population groups.

— An SEA may also address any other issue that is considered to be relevant by the applicant(s) or interested party.

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RESTRICTIONS ON THE MANUFACTURE, PLACING ON THE MARKET AND USE OF CERTAIN
DANGEROUS SUBSTANCES, PREPARATIONS AND ARTICLES

ANNEX XVII

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

1.

Polychlorinated terphenyls (PCTs)
— Preparations,

including waste oils, with a PCT

content higher than 0,005 % by weight.

1.
Shall not be used. However, the following use of
equipment, installations and fluids which were in service
on 30 June 1986 shall continue to be permitted until they
are disposed of or reach the end of their service life:

(a) closed-system electrical equipment transformers, resis-

tors and inductors;

(b) large condensers (≥ 1 kg total weight);

(c) small condensers;

(d) heat-transmitting fluids in closed-circuit heat-transfer

installations;

(e) hydraulic fluids for underground mining equipment.

The Member State may, for reasons of protection of
2.
human health and the environment, prohibit the use of
equipment, installations and fluids covered by paragraph 1
before they are disposed of or reach the end of their
service life.

3.
The placing on the second-hand market of equip-
ment, plant and fluids covered by paragraph 1 which are
not intended for disposal shall be prohibited.

4. Where the Member State considers that it is not
possible for technical reasons to use substitute articles, it
may permit
the use of PCTs and preparations thereof
where the latter are solely intended, in the normal condi-
tions of maintenance of equipment, to supplement the
level of liquids containing PCTs in properly functioning
existing installations purchased before 1 October 1985.

5.
The Member State may, provided prior notification
stating the reasons is sent to the Commission, grant dero-
gations from the ban on the placing on the market and
use of primary and intermediate substances or prepara-
tions,
in so far as they consider that these derogations
have no deleterious effects on human health and the envir-
onment.

to the

6. Without prejudice to the implementation of other
labelling of
relating
Community provisions
dangerous substances and preparations, equipment and
installations containing PCTs must also display instructions
concerning the disposal of PCTs and the maintenance and
use of equipment and installations containing them. These
instructions must be capable of being read horizontally
when the object containing the PCTs is installed in the
normal way. The inscription must stand out clearly from
its background and shall be in a language which is under-
stood in the territory where it is being used.

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Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

2. Chloro-1-ethylene (monomer vinyl chloride)

Shall not be used as aerosol propellant for any use.

CAS No 75-01-4
EINECS No 200-831-0

3.

Liquid substances or preparations, which are regarded
as dangerous according to the definitions in Council
Directive 67/548/EEC and Directive 1999/45/EC.

1.

Shall not be used in:

— ornamental objects,

colour effects by means of different phases,
example in ornamental lamps and ashtrays,

intended to produce light or
for

— tricks and jokes,

— games for one or more participants, or any object
intended to be used as such, even with ornamental
aspects.

2. Without prejudice to paragraph 1, substances and
preparations which:

— present an aspiration hazard and are labelled with R65,

and

— can be used as fuel in decorative lamps, and

— are placed on the market in packaging of a capacity of

15 litres or less,

shall not contain a colouring agent, unless required for
fiscal reasons, or perfume or both.

3. Without prejudice to the implementation of other
Community provisions relating to the classification, packa-
ging and labelling of dangerous substances and prepara-
tions,
substances and preparations
covered by paragraph 2, where intended for use in lamps,
must be marked legibly and indelibly as follows:

the packaging of

‘Keep lamps filled with this liquid out of the reach of chil-
dren’.

Shall not be used in textile articles, such as garments,
undergarments and linen, intended to come into contact
with the skin.

1.
Not permitted in toys or parts of toys as placed on
the market where the concentration of benzene in the free
state is in excess of 5 mg/kg of the weight of the toy or
part of toy.

2.
to, or
Shall not be used in concentrations equal
greater than, 0,1 % by mass in substances or preparations
placed on the market.

3.

However, paragraph 2 shall not apply to:

(a) motor fuels which are covered by Directive 98/70/EC;

(b) substances and preparations

for use in industrial
processes not allowing for the emission of benzene in
quantities in excess of those laid down in existing legis-
lation;

(c) waste covered by Council Directive 91/689/EEC of
12 December 1991 on hazardous waste (1) and
Directive 2006/12/EC.

4. Tris (2,3 dibromopropyl) phosphate

CAS No 126-72-7

5. Benzene

CAS No 71-43-2
EINECS No 200-753-785

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Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

The placing on the market and use of these fibres
1.
and of articles containing these fibres added intentionally
shall be prohibited.

However, Member States may except the placing on the
market and use of diaphragms containing chrysotile (point
(f)) for existing electrolysis installations until they reach the
end of
their service life, or until suitable asbestos-free
substitutes become available, whichever is the sooner. The
Commission will
before
review this
1 January 2008.

derogation

2.
The use of articles containing asbestos fibres referred
to in paragraph 1 which were already installed and/or in
service before 1 January 2005 shall continue to be
permitted until they are disposed of or reach the end of
their service life. However, Member States may, for reasons
of protection of human health, prohibit the use of such
articles before they are disposed of or reach the end of
their service life.

Member States shall not permit the introduction of new
applications for chrysotile asbestos on their territories.

3. Without prejudice to the application of other Com-
munity provisions on the classification, packaging and
labelling of dangerous substances and preparations, the
placing on the market and use of these fibres and of arti-
cles containing these fibres, as permitted according to the
preceding derogations, shall be permitted only if the arti-
cles bear a label
in accordance with the provisions of
Appendix 7 to this Annex.

Shall not be used in textile articles, such as garments,
undergarments and linen, intended to come into contact
with the skin.

1.
Shall not be used in jokes and hoaxes or in objects
intended to be used as such, for instance as a constituent
of sneezing powder and stink bombs.

However, paragraph 1 does not apply to stink

2.
bombs containing not more than 1,5 ml of liquid.

6. Asbestos fibres
(a) Crocidolite

CAS No 12001-28-4

(b) Amosite

CAS No 12172-73-5

(c) Anthophyllite

CAS No 77536-67-5

(d) Actinolite

CAS No 77536-66-4

(e) Tremolite

CAS No 77536-68-6

(f) Chrysotile (2)

CAS No 12001-29-5
CAS No 132207-32-0

7. Tris(aziridinyl)phosphinoxide

CAS No 5455-55-1

8.

Polybromobiphenyls; Polybrominatedbiphenyls (PBB)
CAS No 59536-65-1

9.

Soap bark powder (Quillaja saponaria) and its deriva-
tives containing saponines

Powder of the roots of Helleborus viridis and Helleborus
niger
Powder of the roots of Veratrum album and Veratrum
nigrum
Benzidine and/or its derivatives
CAS No 92-87-5
EINECS No 202-199-1
o-Nitrobenzaldehyde
CAS No 552-89-6
Wood powder

10. Ammonium sulphide
CAS No 12135-76-1
Ammonium hydrogen sulphide
CAS No 12124-99-1
Ammonium polysulphide
CAS No 9080-17-5
EINECS No 232-989-1

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Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

11. Volatile esters of bromoacetic acids:

Methyl bromoacetate

CAS No 96-32-2

EINECS No 202-499-2

Ethyl bromoacetate

CAS No 105-36-2

EINECS No 203-290-9

Propyl bromoacetate

CAS No 35223-80-4

Butyl bromoacetate

12. 2-Naphthylamine
CAS No 91-59-8
EINECS No 202-080-4
and its salts

13. Benzidine

CAS No 92-87-5
EINECS No 202-199-1
and its salts
14. 4-Nitrobiphenyl
CAS No 92-93-3
EINECS No 202-204-7
15. 4-Aminobiphenyl xenylamine

CAS No 92-67-1
EINECS No 202-177-1
and its salts

1.
to or
Shall not be used in concentrations equal
greater than 0,1 % by weight in substances and prepara-
tions placed on the market.

this provision shall not

However,
apply to waste
containing one or more of these substances and covered
by Directives 91/689/EEC and 2006/12/EC.

Such substances and preparations shall not be sold to

2.
the general public.

3. Without prejudice to the application of other Com-
munity provisions on the classification, packaging and
labelling of dangerous substances and preparations, the
packaging of such preparations shall be legible and indel-
ibly marked as follows:

‘Restricted to professional users’.

16. Lead carbons:

(a) Neutral anhydrous carbonate (PbCO3)

CAS No 598-63-0
EINECS No 209-943-4

(b) Trilead-bis(carbonate)-dihydroxide

Pb(OH)2
CAS No 1319-46-6
EINECS No 215-290-6

2 Pb CO3-

Shall not be used as substances and a constituent of
preparations intended for use as paints, except for the
restoration and maintenance of works of art and historic
buildings and their interiors, where Member States wish to
permit this on their territory, in accordance with the provi-
sions of ILO Convention 13 on the use of white lead and
sulphates of lead in paint.

17. Lead sulphates

(a) PbSO4 (1:1)

CAS No 7446-14-2
EINECS No 231-198-9

(b) Pbx SO4

CAS No 15739-80-7
EINECS No 239-831-0

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Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

18. Mercury compound

19. Arsenic compounds

Shall not be used as substances and constituents of

1.
preparations intended for use:

(a) to prevent the fouling by micro-organisms, plants or

animals of:

— the hulls of boats,

— cages,

floats, nets and any other appliances or

equipment used for fish or shellfish farming,

— any totally or partly submerged appliances or

equipment;

(b) in the preservation of wood;

(c) in the impregnation of heavy-duty industrial textiles

and yarn intended for their manufacture;

(d) in the treatment of industrial waters,

irrespective of

their use.

2.
The placing on the market of batteries and accumula-
tors, containing more than 0,0005 % of mercury by
weight, including in those cases where these batteries and
accumulators are incorporated into appliances shall be
prohibited. Button cells and batteries composed of button
cells with a mercury content of no more than 2 % by
weight shall be exempted from this prohibition.

Shall not be used as substances and constituents of

1.
preparations intended for use:

(a) to prevent the fouling by micro-organisms, plants or

animals of:

— the hulls of boats,

— cages,

floats, nets and any other appliances or

equipment used for fish or shellfish farming,

— any totally or partly submerged appliances or

equipment;

(b) in the preservation of wood. Furthermore, wood so

treated shall not be placed on the market;

(c) however, by way of derogation:

(i) Relating to the substances and preparations in the
preservation of wood: these may only be used in
industrial
installations using vacuum or pressure
to impregnate wood if they are solutions of inor-
ganic
chromium,
arsenic (CCA) type C. Wood so treated shall not
be placed on the market before fixation of the
preservative is completed.

compounds of

copper,

the

(ii) Relating to wood treated with CCA solutions in
industrial installations according to point (i): this
may be placed on the market for professional and
industrial use provided that the structural integrity
of the wood is required for human or livestock
safety and skin contact by the general public
during its service life is unlikely:

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Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

— as structural timber in public and agricultural
and industrial

buildings, office buildings,
premises,

— in bridges and bridgework,

— as constructional timber in freshwater areas
and brackish waters e.g. jetties and bridges,

— as noise barriers,

— in avalanche control,

— in highway safety fencing and barriers,

— as debarked round conifer

livestock fence

posts,

— in earth retaining structures,

— as electric power transmission and telecommu-

nications poles,

— as underground railway sleepers.

Without prejudice to the application of other
classification,
Community provisions on the
packaging and labelling of dangerous substances
and preparations, all treated wood placed on the
market shall be individually labelled ‘For profes-
sional and industrial
installation and use only,
contains arsenic’. In addition, all wood placed on
the market in packs shall also bear a label stating
‘Wear gloves when handling this wood. Wear a
dust mask and eye protection when cutting or
otherwise crafting this wood. Waste from this
wood shall be
treated as hazardous by an
authorised undertaking’.

(iii) Treated wood referred to under points (i) and (ii)

shall not be used:

— in residential or domestic constructions, what-

ever the purpose,

— in any application where there is a risk of

repeated skin contact,

— in marine waters,

— for agricultural purposes other than for live-
stock fence posts and structural uses in accord-
ance with point (ii),

— in any application where the treated wood
may come into contact with intermediate or
finished products intended for human and/or
animal consumption.

2.
Shall not be used as substances and constituents of
preparations intended for use in the treatment of industrial
waters, irrespective of their use.

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Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

20. Organostannic compounds

21. Di-µ-oxo-di-n-butylstanniohydroxyborane
hydrogen borate C8H19BO3Sn (DBB)
CAS No 75113-37-0
ELINCS No 401-040-5

dibutyltin

22. Pentachlorophenol

CAS No 87-86-5
EINECS No 201-778-6
and its salts and esters

Shall not be placed on the market

for use as
1.
substances and constituents of preparations when acting as
biocides in free association paint.

Shall not be placed on the market or used as
2.
substances and constituents of preparations which act as
biocides to prevent the fouling by micro-organisms, plants
or animals of:

(a) all craft irrespective of their length intended for use in
marine, coastal, estuarine and inland waterways and
lakes;

(b) cages, floats, nets and any other appliances or equip-

ment used for fish or shellfish farming;

(c) any totally or partly submerged appliance or equip-

ment.

3.
Shall not be used as substances and constituents of
preparations intended for use in the treatment of industrial
waters.

Shall be prohibited in a concentration equal to or greater
than 0,1 % in substances and constituents of preparations
placed on the market. However, this provision shall not
apply to this substance (DBB) or preparations containing it
if these are intended solely for conversion into finished
articles, among which this substance will no longer feature
in a concentration equal to or greater than 0,1 %.

1.
Shall not be used in a concentration equal to or
greater than 0,1 % by mass in substances or preparations
placed on the market.

2.

Transitional provisions:

By way of derogation until 31 December 2008 France,
Ireland, Portugal, Spain and the United Kingdom may
chose not
to apply this provision to substances and
preparations intended for use in industrial installations not
permitting the emission and/or discharge of pentachloro-
phenol (PCP) in quantities greater than those prescribed by
existing legislation:
(a) in the treatment of wood.

However, treated wood shall not be used:

— inside buildings whether for decorative purposes or
not, whatever their purpose (residence, employ-
ment, leisure),

— for the manufacture and re-treatment of:

(i) containers intended for growing purposes;

(ii) packaging that may come into contact with
raw materials,
finished
products destined for human and/or animal
consumption;

intermediate

or

(iii) other materials

that may contaminate the

products mentioned in (i) and (ii);

C 276E/130

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14.11.2006

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

(b) in the impregnation of fibres and heavy-duty textiles
not intended in any case for clothing or for decorative
furnishings;

(c) by way of special exception, Member States may on a
case-by-case basis, permit on their territory specialised
professionals to carry out in situ and for buildings of
cultural, artistic and historical interest, or in emergen-
cies, a remedial
timber and masonry
infected by dry rot fungus (Serpula lacrymans) and cubic
rot fungi.

treatment of

In any case:

(a) Pentachlorophenol used alone or as a component of
preparations employed within the framework of the
above exceptions must have a total hexachlorodiben-
zoparadioxin (HCDD) content of not more than two
parts per million (ppm);

(b) these substances and preparations shall not:

— be placed on the market except in packages of 20

litres or more;

— be sold to the general public.

3. Without prejudice to the implementation of other
classification,
Community provisions
packaging and labelling of dangerous
substances and
preparations, the packaging of substances and preparations
covered by paragraphs 1 and 2 shall be marked clearly and
indelibly:

concerning

the

23. Cadmium

CAS No 7440-43-9
EINECS No 231-152-8
and its compounds

‘Reserved for industrial and professional use’.

This provision shall not apply to waste covered by Direc-
tives 91/689/EEC and 2006/12/EC.

1.
Shall not be used to give colour to finished articles
manufactured from the substances and preparations listed
below:

(a) — polyvinyl chloride (PVC)

[3904 10]

[3904 21]

[3904 22] (3)

— polyurethane (PUR) [3909 50] (3)
— low-density polyethylene (ld PE), with the exception
of low-density polyethylene used for the produc-
tion of coloured masterbatch [3901 10] (3)
— cellulose acetate (CA) [3912 11] [3912 12] (3)
— cellulose

[3912 11]

butyrate

acetate

(CAB)

[3912 12] (3)

— epoxy resins [3907 30] (3)
— melamine — formaldehyde

[3909 20] (3)

(MF)

resins

— urea — formaldehyde (UF) resins [3909 10] (3)
— unsaturated polyesters (UP) [3907 91] (3)
— polyethylene terephthalate (PET) [3907 60] (3)
— polybutylene terephthalate (PBT) (3)
— transparent/general-purpose polystyrene [3903 11]

[3903 19] (3)

— acrylonitrile methylmethacrylate (AMMA) (3)
— cross-linked polyethylene (VPE) (3)
— high-impact polystyrene (3)
— polypropylene (PP) [3902 10] (3)

14.11.2006

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C 276E/131

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

(b) paints [3208] [3209] (3)

However, if the paints have a high zinc content, their
residual concentration of cadmium shall be as low as
possible and shall at all events not exceed 0,1 % by
mass.

In any case, whatever their use or intended final purpose,
finished articles or components of articles manufactured
from the substances and preparations listed above coloured
with cadmium shall not be placed on the market if their
cadmium content (expressed as Cd metal) exceeds 0,01 %
by mass of the plastic material.

However, paragraph 1 does not apply to articles to

2.
be coloured for safety reasons.

Shall not be used to stabilise the finished articles
3.
listed below manufactured from polymers or copolymers
of vinyl chloride:

— packaging materials

(bags, containers, bottles,

lids)

[3923 29 10] [3920 41] [3920 42] (3)

— office or school supplies [3926 10] (3)

— fittings

for
[3926 30] (3)

furniture,

coachwork

or

the

like

— articles of apparel and clothing accessories (including

gloves) [3926 20] (3)

— floor and wall coverings [3918 10] (3)

— impregnated, coated, covered or

laminated textile

fabrics [5903 10] (3)

— imitation leather [4202] (3)

— gramophone records [8524 10] (3)

— tubes and pipes and their fittings [3917 23] (3)

— swing doors (3)

— vehicles for road transport (interior, exterior, under-

body) (3)

— coating of steel sheet used in construction or

in

industry (3)

— insulation for electrical wiring (3)

In any case, whatever their use or intended final purpose,
the placing on the market of the above finished articles or
components of articles manufactured from polymers or
copolymers of vinyl chloride, stabilised by substances
containing cadmium shall be prohibited, if their cadmium
content (expressed as Cd metal) exceeds 0,01 % by mass of
the polymer.

4.
However, paragraph 3 does not apply to finished
articles using cadmium-based stabilisers for safety reasons.

C 276E/132

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14.11.2006

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

‘cadmium
5. Within the meaning of this Regulation,
plating’ means any deposit or coating of metallic cadmium
on a metallic surface.

Shall not be used for cadmium plating metallic articles or
components of the articles used in the sectors/applications
listed below:

(a) equipment and machinery for:

— food production [8210]

[8417 20]

[8421 11]
[8438] [8476 11] (3)

[8421 22]

[8422]

[8419 81]
[8437]

[8435]

— agriculture [8419 31] [8424 81] [8432] [8433]

[8434] [8436] (3)

— cooling and freezing [8418] (3)

— printing

and

book-binding

[8440]

[8442]

[8443] (3)

(b) equipment and machinery for the production of:

— household goods [7321] [8421 12] [8450] [8509]

[8516] (3)

— furniture [8465]

[8466]

[9401]

[9402]

[9403]

[9404] (3)

— sanitary ware [7324] (3)

— central heating and air conditioning plant [7322]

[8403] [8404] [8415] (3)

In any case, whatever their use or intended final purpose,
the placing on the market of cadmium-plated articles or
components of such articles used in the sectors/applica-
tions listed in points (a) and (b) above and of articles
manufactured in the sectors listed in point (b) above shall
be prohibited.

6.
The provisions referred to in paragraph 5 are also
applicable to cadmium-plated articles or components of
such articles when used in the sectors/applications listed in
points (a) and (b) below and to articles manufactured in
the sectors listed in (b) below:

(a) equipment and machinery for the production of:

— paper and board [8419 32] [8439] [8441] (3)

— textiles and clothing [8444] [8445] [8447] [8448]

[8449] [8451] [8452] (3)

(b) equipment and machinery for the production of:

— industrial handling equipment
[8428]

[8426]

[8427]

[8425]
[8431] (3)

and machinery
[8430]
[8429]

— road and agricultural vehicles [chapter 87] (3)

— rolling stock [chapter 86] (3)

— vessels [chapter 89] (3)

14.11.2006

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Official Journal of the European Union

C 276E/133

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

24. Monomethyl — tetrachlorodiphenyl methane

Trade name: Ugilec 141
CAS No 76253-60-6

However, the restrictions in paragraphs 5 and 6 do

7.
not apply to:

— articles and components of the articles used in the
aeronautical, aerospace, mining, offshore and nuclear
sectors whose applications require high safety stan-
dards and in safety devices in road and agricultural
vehicles, rolling stock and vessels,

— electrical contacts in any sector of use, on account of
the reliability required of the apparatus on which they
are installed.

Owing to the development of knowledge and techniques
in respect of substitutes less dangerous than cadmium and
its compounds, the Commission shall, in consultation with
the Member States, assess the situation at regular intervals
in accordance with the procedure laid down in Art 132(3)
of this Regulation.

1.
The placing on the market and use of this substance
and of preparations and articles containing it shall be
prohibited.
2.

By way of exception paragraph 1 shall not apply:

(a) in the case of plant and machinery already in service
on 18 June 1994 until such plant and machinery is
disposed of.

However, Member States may, on grounds of human
health protection and
environmental protection,
prohibit within their territory the use of such plant or
machinery before it is disposed of;

(b) in the case of the maintenance of plant and machinery
State on
in service within a Member

already
18 June 1994.

The placing on the second-hand market of

this
3.
substance, preparations containing this
substance and
plant/machinery containing this substance, shall be prohib-
ited.

25. Monomethyl-dichloro-diphenyl methane

Trade name: Ugilec 121, Ugilec 21; CAS No —
unknown

The placing on the market and use of this substance and
of preparations and articles containing it shall be prohib-
ited.

26. Monomethyl-dibromo-diphenyl methane bromoben-

zylbromotoluene, mixture of isomers
Trade name: DBBT
CAS No 99688-47-8

The placing on the market and use of this substance and
of preparations and articles containing it shall be prohib-
ited.

27. Nickel

CAS No 7440-02-0
EINECS No 231-111-4
and its compounds

1.

Shall not be used:

(a) in post assemblies which are inserted into pierced ears
and other pierced parts of the human body during
epithelisation of
the wound caused by piercing,
whether subsequently removed or not, unless such
post assemblies are homogeneous and the concentra-
tion of nickel — expressed as mass of nickel to total
mass — is less than 0,05%;

(b) in articles intended to come into direct and prolonged

contact with the skin such as:

— earrings,

— necklaces, bracelets and chains, anklets,

finger

rings,

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14.11.2006

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

— wrist-watch cases, watch straps and tighteners,

— rivet buttons, tighteners, rivets, zippers and metal

marks, when these are used in garments,

— if the rate of nickel release from the parts of these
articles coming into direct and prolonged contact
with the skin is greater than 0,5 µg/cm2/week;

(c) in articles such as those listed in point (b) where these
have a non-nickel coating unless such coating is suffi-
cient to ensure that the rate of nickel release from
those parts of such articles coming into direct and
prolonged contact with the skin will not exceed 0,5 µg/
cm2/week for a period of at least two years of normal
use of the article.

2.
Articles which are the subject of paragraph 1, shall
not be placed on the market unless they conform to the
requirements set out in those points.

3.
The standards adopted by the European Committee
for Standardisation (CEN) shall be used as the test methods
for demonstrating the conformity of articles to paragraphs
1 and 2.

28. Substances which appear in Annex I

to Directive
67/548/EEC classified as carcinogen category 1 or
carcinogen category 2 and labelled at least as ‘Toxic
(T)’ with risk phrase R 45: ‘May cause cancer’ or risk
phrase R49:
‘May cause cancer by inhalation’, and
listed as follows:
Carcinogen category 1 listed in Appendix 1.

Carcinogen category 2 listed in Appendix 2.

Without prejudice to the other parts of this Annex the
following shall apply to entries 28 to 30:

Shall not be used in substances and preparations
1.
placed on the market for sale to the general public in indi-
vidual concentration equal to or greater than:

— either the relevant concentration specified in Annex I

to Directive 67/548/EEC, or

— the

relevant
1999/45/EC.

concentration specified in Directive

29. Substances which appear in Annex I

to Directive
67/548/EEC classified as mutagen category 1 or
mutagen category 2 and labelled with risk phrase
R46: ‘May cause heritable genetic damage’, and listed
as follows:
Mutagen category 1 listed in Appendix 3.

Mutagen category 2 listed in Appendix 4.

Without prejudice to the implementation of other Com-
munity provisions relating to the classification, packaging
and labelling of dangerous substances and preparations,
the packaging of such substances and preparations must
be marked legibly and indelibly as follows:

‘Restricted to professional users’.

30. Substances which appear in Annex I

to Directive
67/548/EEC classified as toxic to reproduction cate-
gory 1 or toxic to reproduction category 2 and
‘May impair fertility’
labelled with risk phrase R60:
and/or R61:
‘May cause harm to the unborn child’,
and listed as follows:
Toxic to reproduction category 1 listed in Appendix
5.

Toxic to reproduction category 2 listed in Appendix
6.

By way of derogation, paragraph 1 shall not apply

2.
to:

(a) medicinal or veterinary products as defined by Direc-

tive 2001/82/EC and Directive 2001/83/EC;

(b) cosmetic products as defined by Council Directive

76/768/EEC;

(c) — motor

fuels which are

covered by Directive

98/70/EC,

— mineral oil products intended for use as fuel

in

mobile or fixed combustion plants,

— fuels sold in closed systems (e.g. liquid gas bottles);

(d) artists' paints covered by Directive 1999/45/EC.

14.11.2006

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C 276E/135

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

31.

(a) creosote; wash oil

CAS No 8001-58-9
EINECS No 232-287-5

(b) creosote oil; wash oil
CAS No 61789-28-4
EINECS No 263-047-8

Shall not be used as substances or in preparations in
1.
the treatment of wood. Furthermore, wood so treated shall
not be placed on the market.

(c) distillates (coal tar), naphthalene oils; naphthalene

2.

However by way of derogation:

oil
CAS No 84650-04-4
EINECS No 283-484-8

(d) creosote oil, acenaphthene fraction; wash oil

CAS No 90640-84-9
EINECS No 292-605-3

(e) distillates (coal tar), upper; heavy anthracene oil

CAS No 65996-91-0
EINECS No 266-026-1

(f) anthracene oil

CAS No 90640-80-5
EINECS No 292-602-7

(g) tar acids, coal, crude; crude phenols

CAS No 65996-85-2
EINECS No 266-019-3

(h) creosote, wood

CAS No 8021-39-4
EINECS No 232-419-1

(i) low temperature tar oil, alkaline; extract residues

(coal), low temperature coal tar alkaline
CAS No 122384-78-5
EINECS No 310-191-5

(a) Relating to the substances and preparations: these may
be used for wood treatment in industrial installations
or by professionals covered by Community legislation
on the protection of workers for in situ retreatment
only if they contain:

(i) benzo[a]pyrene at a concentration of

less than

0,005% by mass

(ii) and water extractable phenols at a concentration of

less than 3 % by mass.

Such substances and preparations for use in wood
treatment in industrial installations or by professionals:

— may be placed on the market only in packaging of

a capacity equal to or greater than 20 litres,

— shall not be sold to consumers.

Without prejudice to the application of other Com-
munity provisions on the classification, packaging and
labelling of dangerous substances and preparations, the
packaging of such substances and preparations shall be
legibly and indelibly marked as follows:

‘For use in industrial installations or professional treat-
ment only’.

(b) Relating to wood treated in industrial installations or
by professionals according to point (a) which is placed
on the market for the first time or retreated in-situ: this
is permitted for professional and industrial use only,
in electric power transmission and
e.g. on railways,
agricultural
telecommunications,
purposes (e.g. stakes for tree support) and in harbours
and waterways.

fencing,

for

for

(c) The prohibition in paragraph 1 on the placing on the
market shall not apply to wood which has been treated
with substances listed in entry 31 (a) to (i) before 31
December 2002 and is placed on the second-hand
market for re-use.

However, treated wood referred to under paragraph

3.
2(b) and (c) shall not be used:

— inside buildings, whatever their purpose,

— in toys,

C 276E/136

EN

Official Journal of the European Union

14.11.2006

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

— in playgrounds,

— in parks, gardens, and outdoor recreational and leisure
facilities where there is a risk of frequent skin contact,

— in the manufacture of garden furniture such as picnic

tables,

— for the manufacture and use and any re-treatment of:

— containers intended for growing purposes,

— packaging that may come into contact with raw
products

materials,
destined for human and/or animal consumption,

intermediate

finished

or

— other materials which may contaminate the articles

mentioned above.

1.
to or
Shall not be used in concentrations equal
greater than 0,1 % by weight in substances and prepara-
tions placed on the market for sale to the general public
and/or in diffusive applications such as in surface cleaning
and cleaning of fabrics.

2. Without prejudice to the application of other Com-
munity provisions on the classification, packaging and
labelling of dangerous substances and preparations, the
packaging of such substances and preparations containing
them in concentrations equal to or greater than 0,1 % shall
be legible and indelibly marked as follows:

‘For use in industrial installations only’.

By way of derogation this provision shall not apply to:

(a) medicinal or veterinary products as defined by Direc-

tive 2001/82/EC and Directive 2001/83/EC;

(b) cosmetic products as defined by Directive 76/768/EEC.

32. Chloroform

CAS No 67-66-3
EINECS No 200-663-8

33. Carbon tetrachloride-tetrachloromethane

CAS No 56-23-5
EINECS No 200-262-8
34. 1,1,2 Trichloroethane
CAS No 79-00-5
EINECS No 201-166-9
35. 1,1,2,2 Tetrachloroethane

CAS No 79-34-5
EINECS No 201-197-8
36. 1,1,1,2 Tetrachloroethane

CAS No 630-20-6
37. Pentachloroethane
CAS No 76-01-7
EINECS No 200-925-1

38. 1,1 Dichloroethylene
CAS No 75-35-4
EINECS No 200-864-0

39. 1,1,1 Trichloroethane, methyl chloroform

CAS No 71-55-6
EINECS No 200-756-3

40. Substances meeting the criteria of

flammability in
Directive 67/548/EEC and classified as flammable,
highly flammable or extremely flammable regardless
of whether they appear in Annex I to that Directive
or not.

1.
Shall not be used on their own or in the form of
preparations in aerosol generators that are placed on the
the general public for entertainment and
market
decorative purposes such as the following:

for

— metallic glitter intended mainly for decoration,

— artificial snow and frost,

— ‘whoopee’ cushions,

— silly string aerosols,

14.11.2006

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Official Journal of the European Union

C 276E/137

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

— imitation excrement,

— horn for parties,

— decorative flakes and foams,

— artificial cobwebs,

— stink bombs,

— etc.

2. Without prejudice to the application of other Com-
munity provisions on the classification, packaging and
labelling of dangerous substances,
the following words
must appear legibly and indelibly on the packaging of
aerosol generators referred to above:

‘For professional users only’.

3.
By way of derogation, paragraphs 1 and 2 shall not
apply to the aerosol generators referred to in Article 9a of
Council Directive 75/324/EEC of 20 May 1975 on the
approximation of the laws of the Member States relating
to aerosol dispensers (4).

The articles referred to in paragraphs 1 and 2 shall
4.
not be placed on the market unless they conform to the
requirements indicated.

Shall not be used in the manufacturing or processing of
non-ferrous metals.

41. Hexachloroethane
CAS No 67-72-1
EINECS No 200-6664

42. Alkanes, C10-C13,
paraffins) (SCCPs)
EINECS No 287-476-5

chloro (short-chain chlorinated

Shall not be placed on the market for use as substances or
as constituents of other substances or preparations in
concentrations higher than 1%:

43. Azocolourants

— in metalworking;
— for fat liquoring of leather.

1.
Azodyes which, by reductive cleavage of one or
more azo groups, may release one or more of the aromatic
amines listed in Appendix 8, in detectable concentrations,
i.e. above 30 ppm in the finished articles or in the dyed
parts thereof, according to the testing method established
in accordance with Article 132(3), shall not be used in
textile and leather articles which may come into direct and
prolonged contact with the human skin or oral cavity,
such as:

— clothing, bedding,

towels, hairpieces, wigs, hats,

nappies and other sanitary items, sleeping bags,

— footwear, gloves, wristwatch straps, handbags, purses/
wallets, briefcases, chair covers, purses worn round the
neck,

— textile or leather toys and toys which include textile or

leather garments,

C 276E/138

EN

Official Journal of the European Union

14.11.2006

Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

— yarn and fabrics

intended for use by the final

consumer.

Furthermore, the textile and leather articles referred
2.
to in paragraph 1 above shall not be placed on the market
unless they conform to the requirements set out in that
paragraph.

Azodyes, which are contained in Appendix 9, ‘List of
3.
azodyes’, shall not be placed on the market or used for
colouring textile and leather articles as a substance or
constituent of preparations in concentrations higher than
0,1 % by mass.

The Commission shall, in the light of new scientific

4.
knowledge, review the provisions on azocolourants.

Shall not be placed on the market or used as a
1.
substance or as a constituent of preparations in concentra-
tions higher than 0,1 % by mass.

2.
Articles may not be placed on the market if they, or
flame-retarded parts thereof, contain this substance in
concentrations higher than 0,1 % by mass.

1.
Shall not be placed on the market or used as a
substance or as a constituent of substances or of prepara-
tions in concentrations higher than 0,1 % by mass.

2.
Articles may not be placed on the market if they, or
flame-retardant parts thereof, contain this substance in
concentrations higher than 0,1 % by mass.

44. Diphenylether, pentabromo derivative C12H5Br5O

45. Diphenylether, octabromo derivative C12H2Br8O

46.

(a) Nonylphenol C6H4(OH)C9H19
(b) Nonylphenol ethoxylate (C2H4O)nC15H24O

Shall not be placed on the market or used as a substance
or constituent of preparations in concentrations equal or
higher than 0,1 % by mass for the following purposes:

(1) industrial and institutional cleaning except:

— controlled closed dry cleaning systems where the

washing liquid is recycled or incinerated,

— cleaning systems with special treatment where the

washing liquid is recycled or incinerated;

(2) domestic cleaning;

(3) textiles and leather processing except:

— processing with no release into waste water,

— systems with special treatment where the process
water is pre-treated to remove the organic fraction
completely prior to biological waste water treat-
ment (degreasing of sheepskin);

(4) emulsifier in agricultural teat dips;

(5) metal working except:

— uses

in controlled closed systems where

the

washing liquid is recycled or incinerated;

(6) manufacturing of pulp and paper;

(7) cosmetic products;

(8) other personal care products except:

— spermicides.

(9) co-formulants in pesticides and biocides.

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Designation of the substance, of the groups of substances or of
the preparation

Conditions of restriction

47. Cement

Cement and cement-containing preparations shall
1.
not be used or placed on the market, if they contain, when
hydrated, more than 0,0002 % soluble chromium VI of the
total dry weight of the cement.

If reducing agents are used, then without prejudice to
2.
the application of other Community provisions on the
classification, packaging
and labelling of dangerous
substances and preparations, the packaging of cement or
cement-containing preparations shall be legibly and indel-
ibly marked with information on the packing date, as well
as on the storage conditions and the storage period appro-
priate to maintaining the activity of the reducing agent
and to keeping the content of soluble chromium VI below
the limit indicated in paragraph 1.

By way of derogation, paragraphs 1 and 2 shall not
3.
apply to the placing on the market
for, and use in,
controlled closed and totally automated processes in which
cement and cement-containing preparations are handled
solely by machines and in which there is no possibility of
contact with the skin.

(1) OJ L 377, 31.12.1991, p. 20. Directive as last amended by Regulation (EC) No 166/2006 of the European Parliament and of the

Council (OJ L 33, 4.2.2006, p. 1).

(2) Chrysotile has two CAS Nos, confirmed by ECB.
(3) Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff

(OJ L 256, 7.9.1987). Regulation as last amended by Regulation (EC) No 996/2006 (OJ L 179, 1.7.2006, p. 27).
(4) OJ L 147, 9.6.1975, p. 40. Directive as last amended by Regulation (EC) No 807/2003 (OJ L 122, 16.5.2003, p. 36).

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Appendices 1 to 6

FOREWORD

Explanations of column headings

Substances:

The name is the same as that used for the substance in Annex I to Directive 67/548/EEC. Whenever possible dangerous
substances are designated by their EINECS (European Inventory of Existing Commercial Chemical Substances) or ELINCS
(European List of Notified Chemical Substances) names. These are referred to as EC numbers in the table. Other entries
not listed in EINECS or ELINCS are designated using an internationally recognised chemical name (e.g. ISO, IUPAC). An
additional common name is included in some cases.

Index number:

The index number is the identification code given to the substance in Annex I of Directive 67/548/EEC. Substances are
listed in the Appendix according to this index number.

EINECS number:

For each substance listed in the EINECS there is an identification code. The code starts at 200-001 8.

ELINCS number:

For each new substance notified under the Directive 67/548/EEC an identification code has been defined and published
in the ELINCS. The code starts at 400-010-9.

CAS number:

Chemical Abstracts Service (CAS) numbers have been defined for substances to help in their identification.

Notes:

The full text of the notes can be found in the foreword of Annex I to Directive 67/548/EEC.

The notes to be taken into account for the purposes of this Regulation are as follows:

Note C:

Some organic substances may be marketed either in a specific isomeric form or as a mixture of several isomers.

Note D:

Certain substances which are susceptible to spontaneous polymerisation or decomposition are generally placed on the
market in a stabilised form. It is in this form that they are listed in Annex I to Directive 67/548/EEC.

However, such substances are sometimes placed on the market in a non-stabilised form. In this case, the manufacturer
or any person who places such a substance on the market must state on the label the name of the substance followed by
the words ‘non-stabilised’.

Note E:

Substances with specific effects on human health (see chapter 4 of Annex VI of Directive 67/548/EEC) that are classified
as carcinogenic, mutagenic and/or toxic for reproduction in categories 1 or 2 are ascribed Note E if they are also classi-
fied as very toxic (T+), toxic (T) or harmful (Xn). For these substances, the risk phrases R20, R21, R22, R23, R24, R25,
R26, R27, R28, R39, R68 (harmful), R48 and R65 and all combinations of these risk phrases shall be preceded by the
word ‘Also’.

Note J:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1 % w/w
benzene (EINECS No 200-753-7).

Note K:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1 % w/w 1,3-
butadiene (EINECS No 203-450-8).

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Note L:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 3 % DMSO
extract as measured by IP 346.

Note M:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,005 % w/w
benzo[a]-pyrene (EINECS No 200-028-5).

Note N:

The classification as a carcinogen need not apply if the full refining history is known and it can be shown that the
substance from which it is produced is not a carcinogen.

Note P:

The classification as a carcinogen need not apply if it can be shown that the substance contains less than 0,1 % w/w
benzene (EINECS No 200-753-7).

Note R:

The classification as a carcinogen need not apply to fibres with a length weighted geometric mean diameter, less two
standard errors, greater than 6µm.

Note S:

This substance may not require a label according to Article 23 (see section 8 of Annex VI) of Directive 67/548/EEC.

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Appendix 1

Point 28 — Carcinogens: category 1

Substances

Index number

EC number

CAS number

Notes

Chromium (VI) trioxide

024-001-00-0

215-607-8

1333-82-0

Zinc chromates including zinc potassium chromate

024-007-00-3

Nickel monoxide

Nickel dioxide

Dinickel trioxide

Nickel sulphide

028-003-00-2

215-215-7

1313-99-1

028-004-00-8

234-823-3

12035-36-8

028-005-00-3

215-217-8

1314-06-3

028-006-00-9

240-841-2

16812-54-7

Nickel subsulphide

028-007-00-4

234-829-6

12035-72-2

Diarsenic trioxide; arsenic trioxide

033-003-00-0

215-481-4

1327-53-3

Arsenic pentoxide; arsenic oxide

033-004-00-6

215-116-9

1303-28-2

Arsenic acid and its salts

033-005-00-1

Lead hydrogen arsenate

082-011-00-0

232-064-2

7784-40-9

Butane [containing ≥ 0,1 % Butadiene (203-450-8)] [1]

601-004-01-8

203-448-7 [1]

106-97-8 [1]

C, S

Isobutane [containing ≥ 0,1 % Butadiene (203-450-8)] [2]

200-857-2 [2]

75-28-5 [2]

1,3-Butadiene; buta-1,3-diene

601-013-00-X

203-450-8

106-99-0

D

Benzene

601-020-00-8

200-753-7

71-43-2

Vinyl chloride; chloroethylene

602-023-00-7

200-831-0

75-01-4

Bis (chloromethyl) ether

603-046-00-5

208-832-8

542-88-1

Chloromethyl methyl ether; chlorodimethyl ether

603-075-00-3

203-480-1

107-30-2

2-Naphthylamine; beta-naphthylamine

612-022-00-3

202-080-4

91-59-8

Benzidine; 4,4′-diaminobiphenyl; biphenyl-4,4′-ylenediamine

612-042-00-2

202-199-1

92-87-5

Salts of benzidine

Salts of 2-naphthylamine

612-070-00-5

612-071-00-0

209-030-0[1]
210-313-6[2]

553-00-4[1]
612-52-2[2]

Biphenyl-4-ylamine; xenylamine; 4-aminobiphenyl

612-072-00-6

202-177-1

92-67-1

Salts of biphenyl-4-ylamine; salts of xenylamine; salts of 4-
aminobiphenyl

612-073-00-1

Tar, coal; Coal tar

648-081-00-7

232-361-7

8007-45-2

(The by-product
from the destructive distillation of coal.
Almost black semisolid. A complex combination of aromatic
hydro-carbons, phenolic compounds, nitrogen bases and thio-
phene.)

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Substances

Index number

EC number

CAS number

Notes

Tar, coal, high-temp.; Coal tar

648-082-00-2

266-024-0

65996-89-6

temperature,

(The condensation product obtained by cooling, to approxi-
mately ambient
the gas evolved in the high
temperature (greater than 700 °C) destructive distillation of
coal. A black viscous liquid denser than water. Composed
primarily of a complex mixture of condensed ring aromatic
hydrocarbons. May contain minor amounts of phenolic
compounds and aromatic nitrogen bases.)

Tar, coal, low-temp.; Coal oil

648-083-00-8

266-025-6

65996-90-9

(The condensation product obtained by cooling, to approxi-
mately ambient temperature, the gas evolved in low tempera-
ture (less than 700 °C) destructive distillation of coal. A black
viscous liquid denser than water. Composed primarily of
condensed ring aromatic hydrocarbons, phenolic compounds,
aromatic nitrogen bases, and their alkyl derivatives.)

Tar brown-coal;

648-145-00-4

309-885-0

101316-83-0

(An oil distilled from brown-coal tar. Composed primarily of
aliphatic, naphthenic and one- to three-ring aromatic hydro-
carbons, their alkyl derivates, heteroaromatics and one- and
two-ring phenols boiling in the range of approximately 150 °C
to 360 °C.)

Tar, brown-coal, low temp.;

648-146-00-X

309-886-6

101316-84-1

(A tar obtained from low temperature carbonisation and low
temperature gasification of brown coal. Composed primarily
of aliphatic, naphthenic and cyclic aromatic hydrocarbons,
heteroaromatic hydrocarbons and cyclic phenols.)

Distillates (petroleum),
refined base oil

light paraffinic; Unrefined or mildly

649-050-00-0

265-051-5

64741-50-0

(A complex combination of hydrocarbons produced by
vacuum distillation of the residuum from atmospheric distilla-
tion of crude oil. It consists of hydrocarbons having carbon
numbers predominantly in the range of C15 through C30 and
produces a finished oil with a viscosity of less than 19 10-
6 m2·s-1 at 40 °C. It contains a relatively large proportion of
saturated aliphatic hydrocarbons normally present
in this
distillation range of crude oil.)

Distillates (petroleum), heavy paraffinic; Unrefined or mildly
refined base oil

(A complex combination of hydrocarbons produced by
vacuum distillation of the residuum from atmospheric distilla-
tion of crude oil. It consists of hydrocarbons having carbon
numbers predominantly in the range of C20 through C50, and
produces a finished oil with a viscosity of at least 19 10-
6 m2·s-1 at 40 °C. It contains a relatively large proportion of
saturated aliphatic hydrocarbons.)

Distillates (petroleum), light naphthenic; Unrefined or mildly
refined base oil

(A complex combination of hydrocarbons produced by
vacuum distillation of the residuum from atmospheric distilla-
tion of crude oil. It consists of hydrocarbons having carbon
numbers predominantly in the range of C15 through C30, and
produces a finished oil with a viscosity of less than 19 10-
6 m2·s-1 at 40 °C. It contains relatively few normal paraffins.)

649-051-00-6

265-052-0

64741-51-1

649-052-00-1

265-053-6

64741-52-2

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Substances

Index number

EC number

CAS number

Notes

Distillates (petroleum), heavy naphthenic; Unrefined or mildly
refined base oil

(A complex combination of hydrocarbons produced by
vacuum distillation of the residuum from atmospheric distilla-
tion of crude oil. It consists of hydrocarbons having carbon
numbers predominantly in the range of C20 through C50, and
produces a finished oil with a viscosity of at least 19 10-
6 m2·s-1 at 40 °C. It contains relatively few normal paraffins.)

Distillates (petroleum), acid-treated heavy naphthenic; Unre-
fined or mildly refined base oil

(A complex combination of hydrocarbons obtained as a raffi-
nate from a sulfuric acid treating process. It consists of hydro-
carbons having carbon numbers predominantly in the range
of C20 through C50, and produces a finished oil with a viscosity
of at least 19 10-6 m2·s-1 at 40 °C. It contains relatively few
normal paraffins.)

Distillates (petroleum), acid-treated light naphthenic; Unrefined
or mildly refined base oil

(A complex combination of hydrocarbons obtained as a raffi-
nate from a sulfuric acid treating process. It consists of hydro-
carbons having carbon numbers predominantly in the range
of C15 through C30, and produces a finished oil with a viscosity
of less than 19 10-6 m2·s-1 at 40 °C. It contains relatively few
normal paraffins.)

Distillates (petroleum), acid-treated heavy paraffinic; Unrefined
or mildly refined base oil

(A complex combination of hydrocarbons obtained as a raffi-
nate from a sulfuric acid process. It consists predominantly of
saturated hydrocarbons having carbon numbers predomi-
nantly in the range of C20 through C50, and produces a
finished oil with a viscosity of at least 19 10-6 m2·s-1 at 40 °C.)

Distillates (petroleum), acid-treated light paraffinic; Unrefined
or mildly refined base oil

(A complex combination of hydrocarbons obtained as a raffi-
nate from a sulfuric acid treating process. It consists predomi-
nantly of saturated hydrocarbons having carbon numbers
predominantly in the range of C15 through C30 and produces a
finished oil having a viscosity of less than 19 10-6 m2·s-1 at
40 °C.)

Distillates (petroleum), chemically neutralised heavy paraffinic;
Unrefined or mildly refined base oil

(A complex combination of hydrocarbons obtained from a
treating process to remove acidic materials. It consists predo-
minantly of hydrocarbons having carbon numbers predomi-
nantly in the range of C20 through C50, and produces a
finished oil with a viscosity of at least 19 10-6 m2·s-1 at 40 °C.
It contains a relatively large proportion of aliphatic hydrocar-
bons.)

Distillates (petroleum), chemically neutralised light paraffinic;
Unrefined or mildly refined base oil

(A complex combination of hydrocarbons produced by a
treating process to remove acidic materials.
It consists of
hydrocarbons having carbon numbers predominantly in the
range of C15 through C30, and produces a finished oil with a
viscosity of less than 19 10-6 m2·s-1 at 40 °C.)

649-053-00-7

265-054-1

64741-53-3

649-054-00-2

265-117-3

64742-18-3

649-055-00-8

265-118-9

64742-19-4

649-056-00-3

265-119-4

64742-20-7

649-057-00-9

265-121-5

64742-21-8

649-058-00-4

265-127-8

64742-27-4

649-059-00-X

265-128-3

64742-28-5

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Substances

Index number

EC number

CAS number

Notes

Distillates
naphthenic; Unrefined or mildly refined base oil

(petroleum),

chemically

neutralised

heavy

649-060-00-5

265-135-1

64742-34-3

(A complex combination of hydrocarbons produced by a
treating process to remove acidic materials.
It consists of
hydrocarbons having carbon numbers predominantly in the
range of C20 through C50, and produces a finished oil with a
viscosity of at least 19 10-6 m2·s-1 at 40 °C. It contains rela-
tively few normal paraffins.)

Distillates (petroleum), chemically neutralised light naphthenic;
Unrefined or mildly refined base oil

(A complex combination of hydrocarbons produced by a
treating process to remove acidic materials.
It consists of
hydrocarbons having carbon numbers predominantly in the
range of C15 through C30, and produces a finished oil with a
viscosity of less than 19 10-6 m2·s-1 at 40 °C. It contains rela-
tively few normal paraffins.)

649-061-00-0

265-136-7

64742-35-4

Erionite

Asbestos

650-012-00-0

650-013-00-6

12510-42-8

12001-29-5
12001-28-4
132207-32-0
12172-73-5
77536-66-4
77536-68-6
77536-67-5

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Appendix 2

Point 28 — Carcinogens: category 2

Substances

Index number

EC number

CAS number

Notes

Beryllium

004-001-00-7

231-150-7

7440-41-7

Beryllium compounds with the exception of aluminium beryllium silicates 004-002-00-2

Beryllium oxide

004-003-00-8

215-133-1

1304-56-9

E

Sulfallate (ISO); 2-chlorallyl diethyldithiocarbamate

006-038-00-4

202-388-9

95-06-7

Dimethylcarbamoyl chloride

006-041-00-0

201-208-6

79-44-7

Diazomethane

Hydrazine

N,N-Dimethylhydrazine

1,2-Dimethylhydrazine

Salts of hydrazine

006-068-00-8

206-382-7

334-88-3

007-008-00-3

206-114-9

302-01-2

007-012-00-5

200-316-0

57-14-7

007-013-00-0

007-014-00-6

540-73-8

Hydrazobenzene; 1,2-diphenylhydrazine

007-021-00-4

204-563-5

122-66-7

Hydrazine bis(3-carboxy-4-hydroxybenzensulfonate)

007-022-00-X

405-030-1

Hexamethylphosphoric triamide; hexamethylphosphoramide

015-106-00-2

211-653-8

680-31-9

Dimethyl sulphate

Diethyl sulphate

1,3-Propanesultone

016-023-00-4

201-058-1

77-78-1

016-027-00-6

200-589-6

64-67-5

016-032-00-3

214-317-9

1120-71-4

Dimethylsulfamoylchloride

016-033-00-9

236-412-4

13360-57-1

Potassium dichromate

Ammonium dichromate

Sodium dichromate

024-002-00-6

231-906-6

7778-50-9

024-003-00-1

232-143-1

7789-09-5

024-004-00-7

234-190-3

10588-01-9

Sodium dichromate, dihydrate

024-004-01-4

234-190-3

7789-12-0

Chromyl dichloride; chromic oxychloride

024-005-00-2

239-056-8

14977-61-8

Potassium chromate

Calcium chromate

Strontium chromate

024-006-00-8

232-140-5

7789-00-6

024-008-00-9

237-366-8

13765-19-0

024-009-00-4

232-142-6

7789-06-2

Chromium III chromate; chromic chromate

024-010-00-X

246-356-2

24613-89-6

Chromium (VI) compounds, with the exception of barium chromate and
of compounds specified elsewhere in Annex I to Directive 67/548/EEC

024-017-00-8

–

–

Sodium chromate

Cobalt dichloride

Cobalt sulphate

Potassium bromate

024-018-00-3

231-889-5

7775-11-3

E

027-004-00-5

231-589-4

7646-79-9

027-005-00-0

233-334-2

10124-43-3

035-003-00-6

231-829-8

7758-01-2

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Substances

Index number

EC number

CAS number

Notes

Cadmium oxide

Cadmium fluoride

Cadmium chloride

Cadmium sulphate

048-002-00-0

215-146-2

1306-19-0

048-006-00-2

232-222-0

7790-79-6

048-008-00-3

233-296-7

10108-64-2

048-009-00-9

233-331-6

10124-36-4

Benzo[a]pyrene; benzo[d,e,f]chrysene

601-032-00-3

200-028-5

50-32-8

Benzo[a]anthracene

601-033-00-9

200-280-6

56-55-3

Benzo[b]fluoranthene; benzo[e]acephenanthrylene

601-034-00-4

205-911-9

205-99-2

Benzo[j]fluoranthene

Benzo[k]fluoranthene

Dibenz[a,h]anthracene

Chrysene

Benzo[e]pyrene

601-035-00-X

205-910-3

205-82-3

601-036-00-5

205-916-6

207-08-9

601-041-00-2

200-181-8

53-70-3

601-048-00-0

205-923-4

218-01-9

601-049-00-6

205-892-7

192-97-2

1,2-Dibromoethane; ethylene dibromide

602-010-00-6

203-444-5

106-93-4

1,2-Dichloroethane; ethylene dichloride

602-012-00-7

203-458-1

107-06-2

1,2-Dibromo-3-chloropropane

602-021-00-6

202-479-3

96-12-8

Bromoethylene

602-024-00-2

209-800-6

593-60-2

Trichloroethylene; trichloroethene

α-Chlorotoluene; benzyl chloride

602-027-00-9

201-167-4

79-01-6

602-037-00-3

202-853-6

100-44-7

E

α,α,α-Trichlorotoluene; benzotrichloride

602-038-00-9

202-634-5

98-07-7

1,3-Dichloro-2-propanol

Hexachlorobenzene

1,4-Dichlorobut-2-ene

602-064-00-0

202-491-9

96-23-1

602-065-00-6

204-273-9

118-74-1

602-073-00-X

212-121-8

764-41-0

2,3-dibromopropan-1-ol; 2,3-dibromo-1-propanol

602-088-00-1

202-480-9

96-13-9

Ethylene oxide; oxirane

603-023-00-X

200-849-9

75-21-8

1-Chloro-2,3-epoxypropane; epichlorhydrin

603-026-00-6

203-439-8

106-89-8

Propylene oxide; 1,2-epoxypropane; methyloxirane

603-055-00-4

200-879-2

75-56-9

2,2'-Bioxirane; 1,2:3,4-diepoxybutane

603-060-00-1

215-979-1

1464-53-5

2,3-Epoxypropan-1-ol; glycidol

603-063-00-8

209-128-3

556-52-5

Phenyl glycidyl ether; 2,3-epoxypropyl phenyl ether; 1,2-epoxy-3-phenox-
ypropane

603-067-00-X

204-557-2

122-60-1

Styrene oxide; (epoxyethyl)benzene; phenyloxirane

603-084-00-2

202-476-7

96-09-3

Furan

603-105-00-5

203-727-3

110-00-9

R-2,3-epoxy-1-propanol

603-143-00-2

404-660-4

57044-25-4

(R)-1-chloro-2,3-epoxypropane

603-166-00-8

424-280-2

51594-55-9

E

E

E

E

E

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Substances

Index number

EC number

CAS number

Notes

4-Amino-3-fluorophenol

604-028-00-X

402-230-0

399-95-1

5-Allyl-1,3-benzodioxole; safrole

605-020-00-9

202-345-4

94-59-7

3-Propanolide; 1,3-propiolactone

606-031-00-1

200-340-1

57-57-8

Urethane(INN); ethyl carbamate

607-149-00-6

200-123-1

51-79-6

Methyl acrylamidomethoxyacetate (containing ≥ 0,1 % acrylamide)

607-190-00-X

401-890-7

77402-03-0

Methyl acrylamidoglycolate (containing ≥ 0,1 % acrylamide)

607-210-00-7

403-230-3

77402-05-2

Acrylonitrile

2-Nitropropane

608-003-00-4

203-466-5

107-13-1

609-002-00-1

201-209-1

79-46-9

2,4-Dinitrotoluene [1]; dinitrotoluene [2]; dinitrotoluene, technical grade

609-007-00-9

204-450-0 [1]

121-14-2 [1]

5-Nitroacenaphthene

2-Nitronaphthalene

4-Nitrobiphenyl

246-836-1 [2]

25321-14-6 [2]

609-037-00-2

210-025-0

602-87-9

609-038-00-8

209-474-5

581-89-5

609-039-00-3

202-204-7

92-93-3

Nitrofen (ISO); 2,4-dichlorophenyl4-nitrophenyl ether

609-040-00-9

217-406-0

1836-75-5

E

E

E

E

2-Nitroanisole

2,6-Dinitrotoluene

2,3-dinitrotoluene

3,4-dinitrotoluene

3,5-dinitrotoluene

609-047-00-7

202-052-1

91-23-6

609-049-00-8

210-106-0

606-20-2

609-050-00-3

210-013-5

602-01-7

609-051-00-9

210-222-1

610-39-9

609-052-00-4

210-566-2

618-85-9

Hydrazine-tri-nitromethane

609-053-00-X

414-850-9

–

2,5-dinitrotoluene

Azobenzene

609-055-00-0

210-581-4

619-15-8

611-001-00-6

203-102-5

103-33-3

Methyl-ONN-azoxymethyl acetate; methyl azoxy methyl acetate

611-004-00-2

209-765-7

592-62-1

Disodium {5-[(4′-((2,6-hydroxy-3-((2-hydroxy-5-sulphophenyl)azo)pheny-
l)azo) (1,1′-biphenyl)-4-yl)azo]salicylato(4-)} cuprate(2-); CI Direct Brown
95

611-005-00-8

240-221-1

16071-86-6

4-o-Tolylazo-o-toluidine; 4-amino-2′,3-dimethylazobenzene;
GBC base; AAT; o-aminoazotoluene

fast garnet

611-006-00-3

202-591-2

97-56-3

4-Aminoazobenzene

611-008-00-4

200-453-6

60-09-3

Benzidine based azo dyes; 4,4'-diarylazobiphenyl dyes, with the exception
of those specified elsewhere in Annex I to Directive 67/548/EEC

611-024-00-1

–

–

3-[[4′-[(2,4-diaminophenyl)azo][1,1′-biphenyl]-4-
Disodium 4-amino
yl]azo]-5-hydroxy-6-(phenylazo)naphtalene-2,7-disulphonate; C.I. Direct
Black 38

611-025-00-7

217-710-3

1937-37-7

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Substances

Index number

EC number

CAS number

Notes

Tetrasodium 3,3′-[[1,1′-biphenyl]-4,4′-dylbis(azo)]bis[5-amino-4-hydro-
xynaphthalene-2,7-disulphonate]; C.I. Direct Blue 6

611-026-00-2

220-012-1

2602-46-2

Disodium 3,3′-[[1,1′-bifenyl]-4,4′dylbis(azo)]bis[4-aminonaphthalene-1-
sulphonate); C.I. Direct Red 28

611-027-00-8

209-358-4

573-58-0

o-Dianisidine based azo dyes; 4,4'-diarylazo-3,3'-dimethoxybiphenyl dyes
with the exception of those mentioned elsewhere in Annex I to Directive
67/548/EEC

611-029-00-9

o-Tolidine based dyes; 4,4'-diarylazo-3,3'-dimethylbiphenyl dyes, with the
exception
to
Directive 67/548/EEC

those mentioned

in Annex

elsewhere

of

I

611-030-00-4

–

–

–

–

1,4,5,8-Tetraaminoanthraquinone; C.I. Disperse Blue 1

611-032-00-5

219-603-7

2475-45-8

6-hydroxy-1-(3-isopropoxypropyl)-4-methyl-2-oxo-5-[4-(phenylazo)phe-
nylazo]-1,2-dihydro-3-pyridinecarbonitrile

611-057-00-1

400-340-3

85136-74-9

(6-(4-hydroxy-3-(2-methoxyphenylazo)-2-sulfonato-7-naphthylamino)-
1,3,5-triazin-2,4-diyl)bis[(amino-1-methylethyl)-ammonium] formate

611-058-00-7

402-060-7

108225-03-2

Trisodium-[4'-(8-acetylamino-3,6-disulfonato-2-naphthylazo)-4''-(6-
benzoylamino-3-sulfonato-2-naphthylazo)biphenyl-1,3',3'',1'''-tetraolato-
O, O', O'', O''']copper(II)

611-063-00-4

413-590-3

–

Phenylhydrazine [1]

Phenylhydrazinium chloride [2]

Phenylhydrazine hydrochloride [3]

Phenylhydrazinium sulphate (2:1) [4]

612-023-00-9

202-873-5 [1]

100-63-0 [1]

E

200-444-7 [2]

59-88-1 [2]

248-259-0 [3]

27140-08-5 [3]

257-622-2 [4]

52033-74-6 [4]

2-Methoxyaniline; o-anisidine

612-035-00-4

201-963-1

90-04-0

3,3′-Dimethoxybenzidine; o-dianisidine

612-036-00-X

204-355-4

119-90-4

Salts of 3,3′-dimethoxybenzidine; salts of o-dianisidine

612-037-00-5

3,3′-Dimethylbenzidine; o-tolidine

612-041-00-7

204-358-0

119-93-7

4,4′-Diaminodiphenylmethane; 4,4′-methylenedianiline

612-051-00-1

202-974-4

101-77-9

3,3′-Dichlorobenzidine; 3,3′-dichlorobiphenyl-4,4′-ylenediamine

612-068-00-4

202-109-0

91-94-1

Salts of 3,3′-dichlorobenzidine; salts of 3,3′-dichlorobiphenyl-4,4′-ylene-
diamine

612-069-00-X

210-323-0[1]

612-83-9[1]

265-293-1[2]

64969-34-2[2]

277-822-3[3]

74332-73-3[3]

N-nitrosodimethylamine; dimethylnitrosamine

612-077-00-3

200-549-8

62-75-9

2,2′-Dichloro-4,4′-methylenedianiline;
4,4′-Methylene bis(2-chloroaniline)

612-078-00-9

202-918-9

101-14-4

Salts of 2,2′-dichloro-4,4-methylenedianiline;
nebis(2-chloroaniline)

salts of 4,4′-methyle-

612-079-00-4

Salts of 3,3′-dimethylbenzidine; salts of o-tolidine

612-081-00-5

210-322-5[1]

612-82-8[1]

265-294-7[2]

64969-36-4[2]

277-985-0[3]

74753-18-7[3]

1-Methyl-3-nitro-1-nitrosoguanidine

612-083-00-6

200-730-1

70-25-7

C 276E/150

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

4,4′-Methylenedi-o-toluidine

2,2′-(Nitrosoimino)bisethanol

612-085-00-7

212-658-8

838-88-0

612-090-00-4

214-237-4

1116-54-7

o-Toluidine

612-091-00-X

202-429-0

95-53-4

Nitrosodipropylamine

612-098-00-8

210-698-0

621-64-7

4-Methyl-m-phenylenediamine

612-099-00-3

202-453-1

95-80-7

Toluene-2,4-diammonium sulphate

612-126-00-9

265-697-8

65321-67-7

4-Chloraniline

612-137-00-9

203-401-0

106-47-8

Ethyleneimine; aziridine

613-001-00-1

205-793-9

151-56-4

2-Methylaziridine; propyleneimine

613-033-00-6

200-878-7

75-55-8

Captafol (ISO); 1,2,3,6-tetrahydro-N-(1,1,2,2-tetrachloroethylthio) phthali-
mide

613-046-00-7

219-363-3

2425-06-1

Carbadox
dioxide; 2-(methoxycarbonylhydrazonomethyl) quinoxaline 1,4-dioxide

(INN); methyl 3-(quinoxalin-2-ylmethylene)carbazate 1,4-

613-050-00-9

229-879-0

6804-07-5

Acrylamide

Thioacetamide

A mixture of: N-[3-hydroxy-2-(2-methylacryloylamino-methoxy)propoxy-
methyl]-2-methylacrylamide; N-[2,3-Bis-(2-methylacryloylamino-methox-
y)propoxymethyl]-2-methylacrylamide; methacrylamide; 2-methyl-N-(2-
N-2,3-dihydroxypro-
methyl-acryloylaminomethoxymethyl)-acrylamide;
poxymethyl)-2-methylacrylamide

616-003-00-0

201-173-7

79-06-1

616-026-00-6

200-541-4

62-55-5

616-057-00-5

412-790-8

–

Distillates (coal tar), benzole fraction; Light oil

648-001-00-0

283-482-7

84650-02-2

(A complex combination of hydrocarbons obtained by the distillation of
coal tar. It consists of hydrocarbons having carbon numbers primarily in
the range of C4 to C10 and distilling in the approximate range of 80 °C to
160 °C.)

Tar oils, brown-coal; Light oil

648-002-00-6

302-674-4

94114-40-6

(The distillate from lignite tar boiling in the range of approximately 80 °C
to 250 °C. Composed primarily of aliphatic and aromatic hydrocarbons
and monobasic phenols.)

Benzol forerunnings (coal); Light oil redistillate, low boiling

648-003-00-1

266-023-5

65996-88-5

(The distillate from coke oven light oil having an approximate distillation
range below 100 °C. Composed primarily of C4 to C6 aliphatic hydrocar-
bons.)

Distillates (coal tar), benzole fraction, BTX-rich; Light oil redistillate, low
boiling

(A residue from the distillation of crude benzole to remove benzole
fronts. Composed primarily of benzene, toluene and xylenes boiling in
the range of approximately 75 °C to 200 °C.)

648-004-00-7

309-984-9

101896-26-8

J

J

J

14.11.2006

EN

Official Journal of the European Union

C 276E/151

Substances

Index number

EC number

CAS number

Notes

Aromatic hydrocarbons, C6-10, C8-rich; Light oil redistillate, low boiling

648-005-00-2

292-697-5

90989-41-6

Solvent naphtha (coal), light; Light oil redistillate, low boiling

648-006-00-8

287-498-5

85536-17-0

Solvent naphtha (coal), xylene-styrene cut; Light oil redistillate,
mediate boiling

inter-

648-007-00-3

287-502-5

85536-20-5

Solvent naphtha (coal), coumarone-styrene contg.; Light oil redistillate,
intermediate boiling

648-008-00-9

287-500-4

85536-19-2

Naphtha (coal), distn. residues; Light oil redistillate, high boiling

648-009-00-4

292-636-2

90641-12-6

(The residue remaining from the distillation of
recovered naphtha.
Composed primarily of naphthalene and condensation products of indene
and styrene.)

Aromatic hydrocarbons, C8; Light oil redistillate, high boiling

648-010-00-X

292-694-9

90989-38-1

Aromatic hydrocarbons, C8-9, hydrocarbon resin polymn. by-product;
Light oil redistillate, high boiling

(A complex combination of hydrocarbons obtained from the evaporation
of solvent under vacuum from polymerised hydrocarbon resin. It consists
predominantly of aromatic hydrocarbons having carbon numbers predo-
minantly in the range of C8 through C9 and boiling in the range of
approximately 120 °C to 215 °C.)

648-012-00-0

295-281-1

91995-20-9

Aromatic hydrocarbons, C9-12, benzene distn.; Light oil redistillate, high
boiling

648-013-00-6

295-551-9

92062-36-7

648-014-00-1

295-323-9

91995-61-8

J

J

J

J

J

J

J

J

J

Extract residues (coal), benzole fraction alk., acid ext.; Light oil extract
residues, low boiling

(The redistillate from the distillate, freed of tar acids and tar bases, from
bituminous coal high temperature tar boiling in the approximate range of
90 °C to 160 °C. It consists predominantly of benzene, toluene and
xylenes.)

Extract residues (coal tar), benzole fraction alk., acd ext.; Light oil extract
residues, low boiling

(A complex combination of hydrocarbons obtained by the redistillation of
the distillate of high temperature coal tar (tar acid and tar base free). It
consists predominantly of unsubstituted and substituted mononuclear
aromatic hydrocarbons boiling in the range of 85 °C–195 °C.)

Extract residues (coal), benzole fraction acid; Light oil extract residues,
low boiling

(An acid sludge by-product of the sulphuric acid refining of crude high
temperature coal. Composed primarily of sulfuric acid and organic
compounds.)

648-015-00-7

309-868-8

101316-63-6

J

648-016-00-2

298-725-2

93821-38-6

J

C 276E/152

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Extract residues (coal), light oil alk., distn. overheads; Light oil extract resi-
dues, low boiling

(The first
fraction from the distillation of aromatic hydrocarbons,
coumarone, naphthalene and indene rich prefactionator bottoms or
washed carbolic oil boiling substantially below 145 °C. Composed
primarily of C7 and C8 aliphatic and aromatic hydrocarbons.)

648-017-00-8

292-625-2

90641-02-4

Extract residues (coal), light oil alk., acid ext., indene fraction; Light oil
extract residues, intermediate boiling

648-018-00-3

309-867-2

101316-62-5

Extract residues (coal), light oil alk., indene naphtha fraction; Light oil
extract residues, high boiling

(The distillate from aromatic hydrocarbons, coumarone, naphthalene and
indene rich prefractionator bottoms or washed carbolic oils, having an
approximate boiling range of 155 °C to 180 °C. Composed primarily of
indene, indan and trimethylbenzenes.)

648-019-00-9

292-626-8

90641-03-5

Solvent naphtha (coal); Light oil extract residues, high boiling

648-020-00-4

266-013-0

65996-79-4

J

J

J

J

(The distillate from either high temperature coal tar, coke oven light oil,
or coal tar oil alkaline extract residue having an approximate distillation
range of 130 °C to 210 °C. Composed primarily of indene and other
polycyclic ring systems containing a single aromatic ring. May contain
phenolic compounds and aromatic nitrogen bases.)

Distillates (coal tar), light oils, neutral fraction; Light oil extract residues,
high boiling

(A distillate from the fractional distillation of high temperature coal tar.
Composed primarily of alkyl-substituted one ring aromatic hydrocarbons
boiling in the range of approximately 135 °C to 210 °C. May also include
unsaturated hydrocarbons such as indene and coumarone.)

648-021-00-X

309-971-8

101794-90-5

J

Distillates (coal tar), light oils, acid exts.; Light oil extract residues, high
boiling

(This oil
is a complex mixture of aromatic hydrocarbons, primarily
indene, naphthalene, coumarone, phenol and o-, m- and p-cresol and
boiling in the range of 140 °C to 215 °C.)

648-022-00-5

292-609-5

90640-87-2

Distillates (coal tar), light oils; Carbolic oil

648-023-00-0

283-483-2

84650-03-3

(A complex combination of hydrocarbons obtained by distillation of coal
tar. It consists of aromatic and other hydrocarbons, phenolic compounds
and aromatic nitrogen compounds and distills at the approximate range
of 150 °C to 210 °C.)

Tar oils, coal; Carbolic oil

648-024-00-6

266-016-7

65996-82-9

(The distillate from high temperature coal tar having an approximate
distillation range of 130 °C to 250 °C. Composed primarily of naphtha-
lene, alkylnaphthalenes, phenolic compounds, and aromatic nitrogen
bases.)

J

J

J

14.11.2006

EN

Official Journal of the European Union

C 276E/153

Substances

Index number

EC number

CAS number

Notes

Extract residues (coal), light oil alk., acid ext.; Carbolic oil extract residue

648-026-00-7

292-624-7

90641-01-3

(The oil resulting from the acid washing of alkali-washed carbolic oil to
remove the minor amounts of basic compounds (tar bases). Composed
primarily of indene, indan and alkylbenzenes.)

Extract residues (coal), tar oil alk.; Carbolic oil extract residue

648-027-00-2

266-021-4

65996-87-4

(The residue obtained from coal tar oil by an alkaline wash such as
aqueous sodium hydroxide after the removal of crude coal tar acids.
Composed primarily of naphthalenes and aromatic nitrogen bases.)

Extract oils (coal), light oil; Acid Extract

648-028-00-8

292-622-6

90640-99-6

(The aqueous extract produced by an acidic wash of alkali-washed
carbolic oil. Composed primarily of acid salts of various aromatic
nitrogen bases including pyridine, quinoline and their alkyl derivatives.)

Pyridine, alkyl derivs.; Crude tar bases

648-029-00-3

269-929-9

68391-11-7

(The complex combination of polyalkylated pyridines derived from coal
tar distillation or as high-boiling distillates approximately above 150 °C
from the reaction of ammonia with acetaldehyde, formaldehyde or paraf-
ormaldehyde.)

Tar bases, coal, picoline fraction; Distillate bases

648-030-00-9

295-548-2

92062-33-4

(Pyridine bases boiling in the range of approximately 125 °C to 160 °C
obtained by distillation of neutralised acid extract of the base-containing
tar fraction obtained by the distillation of bituminous coal tars. Composed
chiefly of lutidines and picolines.)

Tar bases, coal, lutidine fraction; Distillate bases

648-031-00-4

293-766-2

91082-52-9

Extract oils (coal), tar base, collidine fraction; Distillate bases

648-032-00-X

273-077-3

68937-63-3

(The extract produced by the acid extraction of bases from crude coal tar
aromatic oils, neutralisation, and distillation of
the bases. Composed
primarily of collidines, aniline, toluidines, lutidines, xylidines.)

Tar bases, coal, collidine fraction; Distillate bases

648-033-00-5

295-543-5

92062-28-7

(The destillation fraction boiling in the range of approximately 181 °C to
186 °C from the crude bases obtained from the neutralised, acid-extracted
base-containing tar fractions obtained by the distillation of bituminous
coal tar. It contains chiefly aniline and collidines.)

Tar Bases, coal, aniline fraction; Distillate bases

648-034-00-0

295-541-4

92062-27-6

(The distillation fraction boiling in the range of approximately 180 °C to
200 °C from the crude bases obtained by dephenolating and debasing the
carbolated oil from the distillation of coal tar. It contains chiefly aniline,
collidines, lutidines and toluidines.)

J

J

J

J

J

J

J

J

J

C 276E/154

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Tar bases, coal, toluidine fraction; Distillate bases

648-035-00-6

293-767-8

91082-53-0

648-036-00-1

295-292-1

91995-31-2

648-037-00-7

295-295-8

91995-35-6

648-038-00-2

295-329-1

91995-66-3

J

J

J

J

648-039-00-8

310-170-0

122070-79-5

J

648-040-00-3

310-171-6

122070-80-8

J

648-041-00-9

309-851-5

101316-45-4

M

Distillates (petroleum), alkene-alkyene manuf. pyrolysis oil, mixed with
high-temp. coal tar, indene fraction; Redistillates

(A complex combination of hydrocarbons obtained as a redistillate from
the fractional distillation of bituminous coal high temperature tar and
residual oils that are obtained by the pyrolytic production of alkenes and
alkynes from petroleum products or natural gas. It consists predominantly
of indene and boils in a range of approximately 160 °C to 190 °C.)

Distillates (coal), coal tar-residual pyrolysis oils, naphthalene oils; Redistil-
lates

(The redistillate obtained from the fractional distillation of bituminous
coal high temperature tar and pyrolysis residual oils and boiling in the
range of approximately 190 °C to 270 °C. Composed primarily of substi-
tuted dinuclear aromatics.)

Extract oils (coal), coal tar-residual pyrolysis oils, naphthalene oil, redistil-
late; Redistillates

(The redistillate from the fractional distillation of dephenolated and
debased methylnaphthalene oil obtained from bituminous coal high
temperature tar and pyrolysis residual oils boiling in the approximate
range of 220 °C to 230 °C. It consists predominantly of unsubstituted and
substituted dinuclear aromatic hydrocarbons.)

Extract oils (coal), coal tar-residual pyrolysis oils, naphthalene oils; Redis-
tillates

(A neutral oil obtained by debasing and dephenolating the oil obtained
from the distillation of high temperature tar and pyrolysis residual oils
which has a boiling range of 225 °C to 255 °C. Composed primarily of
substituted dinuclear aromatic hydrocarbons.)

Extract oils (coal), coal tar residual pyrolysis oils, naphthalene oil, distn.
residues; Redistillates

(Residue from the distillation of dephenolated and debased methyl-
naphthalene oil (from bituminous coal tar and pyrolysis residual oils)
with a boiling range of 240 °C to 260 °C. Composed primarily of substi-
tuted dinuclear aromatic and heterocyclic hydrocarbons.)

Absorption oils, bicyclo arom. and heterocyclic hydrocarbon fraction;
Wash oil redistillate

(A complex combination of hydrocarbons obtained as a redistillate from
the distillation of wash oil. It consists predominantly of 2-ringed aromatic
and heterocyclic hydrocarbons boiling in the range of approximately
260 °C to 290 °C.)

Distillates (coal tar), upper, fluorene-rich; Wash oil redistillate

648-042-00-4

284-900-0

84989-11-7

M

(A complex combination of hydrocarbons obtained by the crystallisation
of tar oil. It consists of aromatic and polycyclic hydrocarbons primarily
fluorene and some acenaphthene.)

14.11.2006

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Official Journal of the European Union

C 276E/155

Substances

Index number

EC number

CAS number

Notes

Creosote oil, acenaphthene fraction, acenaphthene-free; Wash oil redistil-
late

remaining after

(The oil
removal by a crystallisation process of
acenaphthene from acenaphthene oil from coal tar. Composed primarily
of naphthalene and alkylnaphthalenes.)

648-043-00-X

292-606-9

90640-85-0

M

Distillates (coal tar), heavy oils; Heavy anthracene oil

648-044-00-5

292-607-4

90640-86-1

(Distillate from the fractional distillation of coal tar of bituminous coal,
with boiling range of 240 °C to 400 °C. Composed primarily of tri- and
polynuclear hydrocarbons and heterocyclic compounds.)

Anthracene oil, acid ext.; Anthracene oil extract residue

648-046-00-6

295-274-3

91995-14-1

M

(A complex combination of hydrocarbons from the base-freed fraction
obtained from the distillation of coal tar and boiling in the range of
approximately 325 °C to 365 °C. It contains predominantly anthracene
and phenanthrene and their alkyl derivatives.)

Distillates (coal tar); Heavy anthracene oil

648-047-00-1

266-027-7

65996-92-1

M

(The distillate from coal tar having an approximate distillation range of
two to four membered
100 °C to 450 °C. Composed primarily of
condensed ring aromatic hydrocarbons, phenolic
compounds, and
aromatic nitrogen bases.)

Distillates (coal tar), pitch, heavy oils; Heavy anthracene oil

648-048-00-7

295-312-9

91995-51-6

M

(The distillate from the distillation of the pitch obtained from bituminous
high temperature tar. Composed primarily of
tri- and polynuclear
aromatic hydrocarbons and boiling in the range of approximately 300 °C
to 470 °C. The product may also contain heteroatoms.)

Distillates (coal tar), pitch; Heavy anthracene oil

648-049-00-2

309-855-7

101316-49-8

M

(The oil obtained from condensation of the vapours from the heat treat-
ment of pitch. Composed primarily of
to four-ring aromatic
compounds boiling in the range of 200 °C to greater than 400 °C.)

two-

Distillates (coal tar), heavy oils, pyrene fraction; Heavy anthracene oil
redistillate

(The redistillate obtained from the fractional distillation of pitch distillate
boiling in the range of approximately 350 °C to 400 °C. Consists predo-
minantly of tri- and polynuclear aromatic and heterocyclic hydrocarbons.)

648-050-00-8

295-304-5

91995-42-5

M

Distillates (coal tar), pitch, pyrene fraction; Heavy anthracene oil redistil-
late

(The redistillate obtained from the fractional distillation of pitch distillate
and boiling in the range of approximately 380 °C to 410 °C. Composed
primarily of tri- and polynuclear aromatic hydrocarbons and heterocyclic
compounds.)

648-051-00-3

295-313-4

91995-52-7

M

C 276E/156

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Paraffin waxes (coal), brown-coal high-temp. tar, carbon-treated; Coal tar
extract

(A complex combination of hydrocarbons obtained by the treatment of
lignite carbonisation tar with activated carbon for removal of trace consti-
tuents and impurities. It consists predominantly of saturated straight and
branched chain hydrocarbons having carbon numbers predominantly
greater than C12.)

Paraffin waxes (coal), brown-coal high-temp. tar, carbon-treated; Coal tar
extract

(A complex combination of hydrocarbons obtained by the treatment of
lignite carbonisation tar with bentonite for removal of trace constituents
and impurities.
It consists predominantly of saturated straight and
branched chain hydrocarbons having carbon numbers predominantly
greater than C12.)

648-052-00-9

308-296-6

97926-76-6

M

648-053-00-4

308-297-1

97926-77-7

M

Pitch; Pitch

648-054-00-X

263-072-4

61789-60-4

M

Pitch, coal tar, high temp.; Pitch

648-055-00-5

266-028-2

65996-93-2

(The residue from the distillation of high temperature coal tar. A black
from 30 °C to 180 °C.
solid with an approximate softening point
Composed primarily of a complex mixture of three or more membered
condensed ring aromatic hydrocarbons.)

Pitch, coal tar, high temp., heat-treated; Pitch

648-056-00-0

310-162-7

121575-60-8

M

(The heat treated residue from the distillation of high temperature coal
tar. A black solid with an approximate softening point from 80 °C to
180 °C. Composed primarily of a complex mixture of three or more
membered condensed ring aromatic hydrocarbons.)

Pitch, coal tar, high temp., secondary; Pitch redistillate

648-057-00-6

302-650-3

94114-13-3

M

(The residue obtained during the distillation of high boiling fractions
from bituminous coal high temperature tar and/or pitch coke oil, with a
softening point of 140 °C to 170 °C according to DIN 52025. Composed
primarily of tri- and polynuclear aromatic compounds which also contain
heteroatoms.)

Residues (coal tar), pitch distn.; Pitch redistillate

648-058-00-1

295-507-9

92061-94-4

M

(Residue from the fractional distillation of pitch distillate boiling in the
range of approximately 400 °C to 470 °C. Composed primarily of poly-
nuclear aromatic hydrocarbons, and heterocyclic compounds.)

Tar, coal, high-temp., distn. and storage residues; Coal tar solids residue

648-059-00-7

295-535-1

92062-20-9

M

(Coke- and ash-containing solid residues that separate on distillation and
thermal treatment of bituminous coal high temperature tar in distillation
installations and storage vessels. Consists predominantly of carbon and
contains a small quantity of hetero compounds as well as ash compo-
nents.)

Tar, coal, storage residues; Coal tar solids residue

648-060-00-2

293-764-1

91082-50-7

M

(The deposit removed from crude coal tar storages. Composed primarily
of coal tar and carbonaceous particulate matter.)

14.11.2006

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Substances

Index number

EC number

CAS number

Notes

Tar, coal, high-temp., residues; Coal tar solids residue

648-061-00-8

309-726-5

100684-51-3

M

(Solids formed during the coking of bituminous coal to produce crude
bituminous coal high temperature tar. Composed primarily of coke and
coal particles, highly aromatised compounds and mineral substances.)

Tar, coal, high-temp., high-solids; Coal tar solids residue

648-062-00-3

273-615-7

68990-61-4

M

(The condensation product obtained by cooling,
to approximately
ambient temperature, the gas evolved in the high temperature (greater
than 700 °C) destructive distillation of coal. Composed primarily of a
complex mixture of condensed ring aromatic hydrocarbons with a high
solid content of coal-type materials.)

Waste solids, coal-tar pitch coking; Coal tar solids residue

648-063-00-9

295-549-8

92062-34-5

M

(The combination of wastes formed by the coking of bituminous coal tar
pitch. It consists predominantly of carbon.)

Extract residues (coal), brown; Coal tar extract

(The residue from extraction of dried coal.)

648-064-00-4

294-285-0

91697-23-3

M

Paraffin waxes (coal), brown-coal-high-temp. tar; Coal tar extract

648-065-00-X

295-454-1

92045-71-1

M

(A complex combination of hydrocarbons obtained from lignite carboni-
sation tar by solvent crystallisation (solvent deoiling), by sweating or an
adducting process. It consists predominantly of straight and branched
chain saturated hydrocarbons having carbon numbers predominantly
greater than C12.)

Paraffin waxes (coal), brown-coal-high-temp. tar, hydrotreated; Coal tar
extract

(A complex combination of hydrocarbons obtained from lignite carboni-
sation tar by solvent crystallisation (solvent deoiling), by sweating or an
adducting process treated with hydrogen in the presence of a catalyst. It
consists predominantly of straight and branched chain saturated hydro-
carbons having carbon numbers predominantly greater than C12.)

Paraffin waxes (coal), brown-coal high-temp tar, silicic acid-treated; Coal
tar extract

(A complex combination of hydrocarbons obtained by the treatment of
lignite carbonisation tar with silicic acid for removal of trace constituents
and impurities.
It consists predominantly of saturated straight and
branched chain hydrocarbons having carbon numbers predominantly
greater than C12.)

648-066-00-5

295-455-7

92045-72-2

M

648-067-00-0

308-298-7

97926-78-8

M

Tar, coal, low-temp., distn. residues; Tar oil, intermediate boiling

648-068-00-6

309-887-1

101316-85-2

M

(Residues from fractional distillation of
tar to
remove oils that boil in a range up to approximately 300 °C. Composed
primarily of aromatic compounds.)

low temperature coal

C 276E/158

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Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Pitch, coal tar, low-temp; Pitch residue

648-069-00-1

292-651-4

90669-57-1

M

(A complex black solid or semi-solid obtained from the distillation of a
low temperature coal tar. It has a softening point within the approximate
range of 40 °C to 180 °C. Composed primarily of a complex mixture of
hydrocarbons.)

Pitch, coal tar, low-temp., oxidised; Pitch residue, oxidised

648-070-00-7

292-654-0

90669-59-3

M

low-
(The product obtained by air-blowing, at elevated temperature,
temperature coal tar pitch. It has a softening-point within the approxi-
mate range of 70 °C to 180 °C. Composed primarily of a complex
mixture of hydrocarbons.)

Pitch, coal
residue, heat-treated

tar,

low-temp., heat-treated; Pitch residue, oxidised; Pitch

648-071-00-2

292-653-5

90669-58-2

M

(A complex black solid obtained by the heat treatment of low temperature
coal tar pitch. It has a softening point within the approximate range of
50 °C to 140 °C. Composed primarily of a complex mixture of aromatic
compounds.)

Distillates (coal-petroleum), condensed ring arom.; Distillates

648-072-00-8

269-159-3

68188-48-7

M

(The distillate from a mixture of coal and tar and aromatic petroleum
streams having an approximate distillation range of 220 °C to 450 °C.
Composed primarily of 3-
to 4-membered condensed ring aromatic
hydrocarbons.)

Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethy-
lene-polypropylene pyrolysis-derived; Pyrolysis products

(A complex combination of hydrocarbons obtained from mixed coal tar
pitch-polyethylene-polypropylene pyrolysis. Composed primarily of poly-
cyclic aromatic hydrocarbons having carbon numbers predominantly in
the range of C20 through C28 and having a softening point of 100 °C to
220 °C according to DIN 52025.)

Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethy-
lene pyrolysis-derived; Pyrolysis products

(A complex combination of hydrocarbons obtained from mixed coal tar
pitch-polyethylene pyrolysis. Composed primarily of polycyclic aromatic
hydrocarbons having carbon numbers predominantly in the range of C20
through C28 and having a softening point of 100 °C to 220 °C according
to DIN 52025.)

Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-poly-
styrene pyrolysis-derived; Pyrolysis products

(A complex combination of hydrocarbons obtained from mixed coal tar
pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic
hydrocarbons having carbon numbers predominantly in the range of C20
through C28 and having a softening point of 100 °C to 220 °C according
to DIN 52025.)

648-073-00-3

309-956-6

101794-74-5

M

648-074-00-9

309-957-1

101794-75-6

M

648-075-00-4

309-958-7

101794-76-7

M

14.11.2006

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Official Journal of the European Union

C 276E/159

Substances

Index number

EC number

CAS number

Notes

Pitch, coal tar-petroleum; Pitch residues

648-076-00-X

269-109-0

68187-57-5

M

(The residue from the distillation of a mixture of coal tar and aromatic
petroleum streams. A solid with a softening point from 40 °C to 180 °C.
Composed primarily of a complex combination of
three or more
membered condensed ring aromatic hydrocarbons.)

Phenanthrene, distn. residues; Heavy anthracene oil redistillate

648-077-00-5

310-169-5

122070-78-4

M

(Residue from the distillation of crude phenanthrene boiling in the
approximate range of 340 °C to 420 °C. It consists predominantly of
phenanthrene, anthracene and carbazole.)

Distillates (coal tar), upper, fluorene-free; Wash oil redistillate

648-078-00-0

284-899-7

84989-10-6

M

(A complex combination of hydrocarbons obtained by the crystallisation
of
It consists of aromatic polycyclic hydrocarbons, primarily
diphenyl, dibenzofuran and acenaphthene.)

tar oil.

Residues (coal tar), creosote oil distn.; Wash oil redistillate

648-080-00-1

295-506-3

92061-93-3

M

(The residue from the fractional distillation of wash oil boiling in the
approximate range of 270 °C to 330 °C. It consists predominantly of
dinuclear aromatic and heterocyclic hydrocarbons.)

Distillates (coal), coke-oven light oil, naphthalene cut; Naphthalene oil

648-084-00-3

285-076-5

85029-51-2

J, M

(The complex combination of hydrocarbons obtained from prefractiona-
tion (continuous distillation) of coke oven light oil. It consists predomi-
nantly of naphthalene, coumarone and indene and boils above 148 °C.)

Distillates (coal tar), naphthalene oils, naphthalene-low; Napththalene oil
redistillate

(A complex combination of hydrocarbons obtained by crystallisation of
naphthalene oil. Composed primarily of naphthalene, alkyl naphthalenes
and phenolic compounds.)

648-086-00-4

284-898-1

84989-09-3

J, M

Distillates (coal tar), naphthalene oil crystn. mother liquor; Naphthalene
oil redistillate

(A complex combination of organic compounds obtained as a filtrate
from the crystallisation of the naphthalene fraction from coal tar and
boiling in the range of approximately 200 °C to 230 °C. Contains chiefly
naphthalene, thionaphthene and alkylnaphthalenes.)

648-087-00-X

295-310-8

91995-49-2

J, M

Extract residues (coal), naphthalene oil, alk.; Naphthalene oil extract
residue

(A complex combination of hydrocarbons obtained from the alkali
washing of naphthalene oil to remove phenolic compounds (tar acids). It
is composed of naphthalene and alkyl naphthalenes.)

648-088-00-5

310-166-9

121620-47-1

J, M

C 276E/160

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Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Extract residues (coal), naphthalene oil, alk., naphthalene-low; Naphtha-
lene oil extract residue

(A complex combination of hydrocarbons remaining after the removal of
naphthalene from alkali-washed naphthalene oil by a crystallisation
process. It is composed primarily of naphthalene and alkyl naphthalenes.)

648-089-00-0

310-167-4

121620-48-2

J, M

Distillates
Naphthalene oil extract residue

(coal

tar), naphthalene oils, naphthalene-free, alk. exts.;

(The oil remaining after the removal of phenolic compounds (tar acids)
from drained naphthalene oil by an alkali wash. Composed primarily of
naphthalene and alkyl naphthalenes.)

Extract residues (coal), naphthalene oil alk., distn. overheads; Naphthalene
oil extract residue

(The distillation from alkali-washed naphthalene oil having an approxi-
mate distillation range of 180 °C to 220 °C. Composed primarily of
naphthalene, alkylbenzenes, indene and indan.)

Distillates (coal tar), naphthalene oils, methylnaphthalene fraction; Methyl-
naphthalene oil

(A distillate from the fractional distillation of high temperature coal tar.
Composed primarily of substituted two ring aromatic hydrocarbons and
aromatic nitrogen bases boiling in the range of approximately 225 °C to
255 °C.)

Distillates (coal tar), naphthalene oils, indole-methylnaphthalene fraction;
Methylnaphthalene oil

(A distillate from the fractional distillation of high temperature coal tar.
Composed primarily of
indole and methylnaphthalene boiling in the
range of approximately 235 °C to 255 °C.)

648-090-00-6

292-612-1

90640-90-7

J, M

648-091-00-1

292-627-3

90641-04-6

J, M

648-092-00-7

309-985-4

101896-27-9

J, M

648-093-00-2

309-972-3

101794-91-6

J, M

Distillates (coal tar), naphthalene oils, acid exts.; Methylnaphtalene oil
extract residue

648-094-00-8

295-309-2

91995-48-1

J, M

(A complex combination of hydrocarbons obtained by debasing the
methylnaphthalene fraction obtained by the distillation of coal tar and
boiling in the range of approximately 230 °C to 255 °C. Contains chiefly
1(2)-methylnaphthalene,
and
biphenyl.)

dimethylnaphthalene

naphthalene,

Extract
naphthalene oil extract residue

residues (coal), naphthalene oil alk., distn. residues; Methyl-

(The residue from the distillation of alkali-washed naphthalene oil having
an approximate distillation range of 220 °C to 300 °C. Composed
primarily of naphthalene, alkylnaphthalenes and aromatic nitrogen bases.)

648-095-00-3

292-628-9

90641-05-7

J, M

Extract oils (coal), acidic,
residue

tar-base free; Methylnaphthalene oil extract

648-096-00-9

284-901-6

84989-12-8

J, M

(The extract oil boiling in the range of approximately 220 °C to 265 °C
from coal tar alkaline extract residue produced by an acidic wash such as
aqueous sulfuric acid after distillation to remove tar bases. Composed
primarily of alkylnaphthalenes.)

14.11.2006

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Official Journal of the European Union

C 276E/161

Substances

Index number

EC number

CAS number

Notes

Distillates (coal tar), benzole fraction, distn. residues; Wash oil

648-097-00-4

310-165-3

121620-46-0

J, M

(A complex combination of hydrocarbons obtained from the distillation
of crude benzole (high temperature coal tar). It may be a liquid with the
approximate distillation range of 150 °C to 300 °C or a semi-solid or
solid with a melting point up to 70 °C. It is composed primarily of
naphthalene and alkyl naphthalenes.)

Creosote oil, high-boiling distillate; Wash oil

648-100-00-9

274-565-9

70321-79-8

J, M

(The high-boiling distillation fraction obtained from the high temperature
carbonisation of bituminous coal which is further refined to remove
excess crystalline salts. It consists primarily of creosote oil with some of
the normal polynuclear aromatic salts, which are components of coal tar
distillates, removed. It is crystal free at approximately 5 °C.)

Extract residues (coal), creosote oil acid; Wash oil extract residue

648-102-00-X

310-189-4

122384-77-4

J, M

(A complex combination of hydrocarbons from the base-freed fraction
from the distillation of coal tar, boiling in the range of approximately
250 °C to 280 °C. It consists predominantly of biphenyl and isomeric
diphenylnaphthalenes.)

Anthracene oil, anthracene paste; Anthracene oil fraction

648-103-00-5

292-603-2

90640-81-6

J, M

(The anthracene-rich solid obtained by the crystallisation and centrifuging
of anthracene oil. It is composed primarily of anthracene, carbazole and
phenanthrene.)

Anthracene oil, anthracene-low; Anthracene oil fraction

648-104-00-0

292-604-8

90640-82-7

J, M

(The oil remaining after the removal, by a crystallisation process, of an
anthracene-rich solid (anthracene paste)
is
composed primarily of
three and four membered aromatic
compounds.)

from anthracene oil.

two,

It

Residues (coal tar), anthracene oil distn.; Anthracene oil fraction

648-105-00-6

295-505-8

92061-92-2

J, M

(The residue from the fraction distillation of crude anthracene boiling in
the approximate range of 340 °C to 400 °C. It consists predominantly of
tri- and polynuclear aromatic and heterocyclic hydrocarbons.)

Anthracene oil, anthracene paste, anthracene fraction; Anthracene oil
fraction

(A complex combination of hydrocarbons from the distillation of anthra-
cene obtained by the crystallisation of anthracene oil from bituminous
high temperature tar and boiling in the range of 330 °C to 350 °C. It
contains chiefly anthracene, carbazole and phenanthrene.)

Anthracene oil, anthracene paste, carbazole fraction; Anthracene oil frac-
tion

(A complex combination of hydrocarbons from the distillation of anthra-
cene obtained by crystallisation of anthrancene oil from bituminous coal
high temperature tar and boiling in the approximate range of 350 °C to
360 °C. It contains chiefly anthracene, carbazole and phenanthrene.)

648-106-00-1

295-275-9

91995-15-2

J, M

648-107-00-7

295-276-4

91995-16-3

J, M

C 276E/162

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14.11.2006

Substances

Index number

EC number

CAS number

Notes

Anthracene oil, anthracene paste, distn. lights; Anthracene oil fraction

648-108-00-2

295-278-5

91995-17-4

J, M

(A complex combination of hydrocarbons from the distillation of anthra-
cene obtained by crystallisation of anthracene oil from bituminous light
temperature tar and boiling in the range of approximately 290 °C to
340 °C. It contains chiefly trinuclear aromatics and their dihydro deriva-
tives.)

Tar oils, coal, low-temp.; Tar oil, high boiling

648-109-00-8

309-889-2

101316-87-4

J, M

(A distillate from low-temperature coal tar. Composed primarily of hydro-
carbons, phenolic compounds and aromatic nitrogen bases boiling in the
range of approximately 160 °C to 340 °C.)

Phenols, ammonia liquor ext.; Alkaline extract

648-111-00-9

284-881-9

84988-93-2

J, M

(The combination of phenols extracted, using isobutyl acetate, from the
ammonia liquor condensed from the gas evolved in low-temperature (less
than 700 °C ) destructive distillation of coal. It consists predominantly of
a mixture of monohydric and dihydric phenols.)

Distillates (coal tar), light oils, alk. exts.; Alkaline extract

648-112-00-4

292-610-0

90640-88-3

J, M

(The aqueous extract from carbolic oil produced by an alkaline wash such
as aqueous sodium hydroxide. Composed primarily of the alkali salts of
various phenolic compounds.)

Extracts, coal tar oil alk.; Alkaline extract

648-113-00-X

266-017-2

65996-83-0

J, M

(The extract from coal tar oil produced by an alkaline wash such as
aqueous sodium hydroxide. Composed primarily of the alkali salts of
various phenolic compounds.)

Distillates (coal tar), naphthalene oils, alk. exts.; Alkaline extract

648-114-00-5

292-611-6

90640-89-4

J, M

(The aqueous extract from naphthalene oil produced by an alkaline wash
such as aqueous sodium hydroxid. Composed primarily of the alkali salts
of various phenolic compounds.)

Extract residues (coal), tar oil alk., carbonated, limed; Crude phenols

648-115-00-0

292-629-4

90641-06-8

J, M

(The product obtained by treatment of coal tar oil alkaline extract with
CO2 and CaO. Composed primarily of CaCO3, Ca(OH)2, Na2CO3 and
other organic and inorganic impurities.)

Tar acids, brown-coal, crude; Crude phenols

648-117-00-1

309-888-7

101316-86-3

J, M

(An acidified alkaline extract of brown coal
primarily of phenol and phenol homologs.)

tar distillate. Composed

Tar acids, brown-coal gasification; Crude phenols

648-118-00-7

295-536-7

92062-22-1

J, M

(A complex combination of organic compounds obtained from brown
coal gasification. Composed primarily of C6-10 hydroxy aromatic phenols
and their homologs.)

14.11.2006

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Official Journal of the European Union

C 276E/163

Substances

Index number

EC number

CAS number

Notes

Tar acids, distn. residues; Distillate phenols

648-119-00-2

306-251-5

96690-55-0

J, M

(A residue from the distillation of crude phenol from coal. It consists
predominantly of phenols having carbon numbers in the range of C8
through C10 with a softening point of 60 °C to 80 °C.)

Tar acids, methylphenol fraction; Distillate phenols

648-120-00-8

284-892-9

84989-04-8

J, M

(The fraction of tar acid rich in 3- and 4-methylphenol, recovered by
distillation of low-temperature coal tar crude tar acids.)

Tar acids, polyalkylphenol fraction; Distillate phenols

648-121-00-3

284-893-4

84989-05-9

J, M

(The fraction of tar acids, recovered by distillation of low-temperature
coal tar crude tar acids, having an approximate boiling range of 225 °C
to 320 °C. Composed primarily of polyalkylphenols.)

Tar acids, xylenol fraction; Distillate phenols

648-122-00-9

284-895-5

84989-06-0

J, M

(The fraction of tar acids, rich in 2,4- and 2,5-dimethylphenol, recovered
by distillation of low-temperature coal tar crude tar acids.)

Tar acids, ethylphenol fraction; Distillate phenols

648-123-00-4

284-891-3

84989-03-7

J, M

(The fraction of tar acids, rich in 3- and 4-ethylphenol, recovered by
distillation of low-temperature coal tar crude tar acids.)

Tar acids, 3,5-xylenol fraction; Distillate phenols

648-124-00-X

284-896-0

84989-07-1

J, M

(The fraction of tar acids, rich in 3,5-dimethylphenol, recovered by distil-
lation of low-temperature coal tar acids.)

Tar acids, residues, distillates, first-cut; Distillate phenols

648-125-00-5

270-713-1

68477-23-6

J, M

(The residue from the distillation in the range of 235 °C to 355 °C of
light carbolic oil.)

Tar acids, cresylic, residues; Distillate phenols

648-126-00-0

271-418-0

68555-24-8

J, M

(The residue from crude coal tar acids after removal of phenol, cresols,
xylenols and any higher boiling phenols. A black solid with a melting
point approximately 80 °C. Composed primarily of polyalkyphenols, resin
gums, and inorganic salts.)

Phenols, C9-11; Distillate phenols

648-127-00-6

293-435-2

91079-47-9

J, M

Tar acids, cresylic; Distillate phenols

648-128-00-1

295-540-9

92062-26-5

J, M

(A complex combination of organic compounds obtained from brown
coal and boiling in the range of approximately 200 °C to 230 °C. It
contains chiefly phenols and pyridine bases.)

Tar acids, brown-coal, C2-alkylphenol fraction; Distillate phenols
(The distillate from the acidification of alkaline washed lignite tar distillate
boiling in the range of approximately 200 °C to 230 °C. Composed
primarily of m- and p-ethylphenol as well as cresols and xylenols.)

648-129-00-7

302-662-9

94114-29-1

J, M

C 276E/164

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Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Extract oils (coal), naphthalene oils; Acid extract

648-130-00-2

292-623-1

90641-00-2

J, M

(The aqueous extract produced by an acidic wash of alkali-washed
naphthalene oil. Composed primarily of acid salts of various aromatic
nitrogen bases including pyridine, quinoline and their alkyl derivatives.)

Tar bases, quinoline derivs.; Distillate bases

648-131-00-8

271-020-7

68513-87-1

J, M

Tar bases, coal, quinoline derivs. fraction; Distillate bases

648-132-00-3

274-560-1

70321-67-4

J, M

Tar bases, coal, distn. residues; Distillate bases

648-133-00-9

274-544-0

92062-29-8

J, M

(The distillation residue remaining after the distillation of the neutralised,
acid-extracted base-containing tar fractions obtained by the distillation of
coal tars. It contains chiefly aniline, collidines, quinoline and quinoline
derivatives and toluidines.)

Hydrocarbon oils, arom., mixed with polyethylene and polypropylene,
pyrolysed, light oil fraction; Heat treatment products

(The oil obtained from the heat treatment of a polyethylene/polypropy-
lene mixture with coal tar pitch or aromatic oils. It consists predomi-
nantly of benzene and its homologs boiling in a range of approximately
70 °C to 120 °C.)

648-134-00-4

309-745-9

100801-63-6

J, M

Hydrocarbon oils, arom., mixed with polyethylene, pyrolysed,
fraction; Heat treatment products

light oil

648-135-00-X

309-748-5

100801-65-8

J, M

(The oil obtained from the heat treatment of polyethylene with coal tar
pitch or aromatic oils.
It consists predominantly of benzene and its
homologs boiling in a range of 70 °C to 120 °C.)

Hydrocarbon oils, arom., mixed with polystyrene, pyrolysed, light oil frac-
tion; Heat treatment products

(The oil obtained from the heat treatment of polystyrene with coal tar
pitch or aromatic oils.
It consists predominantly of benzene and its
homologs boiling in a range of approximately 70 °C to 210 °C.)

Extract residues (coal), tar oil alk., naphthalene distn. residues; Naphtha-
lene oil extract residue

(The residue obtained from chemical oil extracted after the removal of
naphthalene by distillation composed primarily of two to four membered
condensed ring aromatic hydrocarbons and aromatic nitrogen bases.)

648-136-00-5

309-749-0

100801-66-9

J, M

648-137-00-0

277-567-8

736665-18-6

J, M

Creosote oil, low-boiling distillate; Wash oil

648-138-00-6

274-566-4

70321-80-1

J, M

(The low-boiling distillation fraction obtained from the high temperature
carbonisation of bituminous coal, which is further refined to remove
excess crystalline salts. It consists primarily of creosote oil with some of
the normal polynuclear aromatic salts, which are components of coal tar
distillate, removed. It is crystal free at approximately 38 °C.)

14.11.2006

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Official Journal of the European Union

C 276E/165

Substances

Index number

EC number

CAS number

Notes

Tar acids, cresylic, sodium salts, caustic solns.; Alkaline extract

648-139-00-1

272-361-4

68815-21-4

J, M

Extract oils (coal), tar base; Acid extract

648-140-00-7

266-020-9

65996-86-3

J, M

(The extract from coal tar oil alkaline extract residue produced by an
acidic wash such as aqueous sulfuric acid after distillation to remove
naphthalene. Composed primarily of the acid salts of various aromatic
nitrogen bases including pyridine, quinoline, and their alkyl derivatives.)

Tar bases, coal, crude; Crude tar bases

648-141-00-2

266-018-8

65996-84-1

J, M

(The reaction product obtained by neutralising coal tar base extract oil
with an alkaline solution, such as aqueous sodium hydroxide, to obtain
the free bases. Composed primarily of such organic bases as acridine,
phenanthridine, pyridine, quinoline and their alkyl derivatives.)

Residues (coal), liq. solvent extn.;

648-142-00-8

302-681-2

94114-46-2

M

(A cohesive powder composed of coal mineral matter and undissolved
coal remaining after extraction of coal by a liquid solvent.)

Coal liquids, liq. solvent extn. soln.;

648-143-00-3

302-682-8

94114-47-3

M

(The product obtained by filtration of coal mineral matter and undis-
solved coal from coal extract solution produced by digesting coal in a
liquid solvent. A black, viscous, highly complex liquid combination
composed primarily of aromatic and partly hydrogenated aromatic hydro-
carbons, aromatic nitrogen compounds, aromatic sulfur compounds,
phenolic and other aromatic oxygen compounds and their alkyl deriva-
tives.)

Coal liquids, liq. solvent extn.;

648-144-00-9

302-683-3

94114-48-4

M

(The substantially solvent-free product obtained by the distillation of the
solvent from filtered coal extract solution produced by digesting coal in a
liquid solvent. A black semi-solid, composed primarily of a complex
combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen
compounds, aromatic sulfur compounds, phenolic compounds and other
aromatic oxygen compounds, and their alkyl derivatives.)

Light oil (coal), coke-oven; Crude benzole

648-147-00-5

266-012-5

65996-78-3

(The volatile organic liquid extracted from the gas evolved in the high
temperature (greater
than 700 °C ) destructive distillation of coal.
Composed primarily of benzene, toluene, and xylenes. May contain other
minor hydrocarbon constituents.)

Distillates (coal), liq. solvent extn., primary;

648-148-00-0

302-688-0

94114-52-0

(The liquid product of condensation of vapours emitted during the diges-
tion of coal in a liquid solvent and boiling in the range of approximately
30 °C to 300 °C. Composed primarily of partly hydrogenated condensed-
ring aromatic hydrocarbons, aromatic compounds containing nitrogen,
oxygen and sulfur, and their alkyl derivatives having carbon numbers
predominantly in the range of C4 through C14.)

J

J

C 276E/166

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Substances

Index number

EC number

CAS number

Notes

Distillates (coal), solvent extn., hydrocracked;

648-149-00-6

302-689-6

94114-53-1

J

(Distillate obtained by hydrocracking of coal extract or solution produced
by the liquid solvent extraction or supercritical gas extraction process and
boiling in the range of approximately 30 °C to 300 °C. Composed
primarily
naphthenic
compounds, their alkyl derivatives and alkanes with carbon numbers
predominantly in the range of C4 through C14. Nitrogen, sulfur and
oxygen-containing aromatic and hydrogenated aromatic compounds are
also present.)

hydrogenated

aromatic,

aromatic

and

of

Naphtha (coal), solvent extn., hydrocracked;

648-150-00-1

302-690-1

94114-54-2

J

(Fraction of the distillate obtained by hydrocracking of coal extract or
solution produced by the liquid solvent extraction or supercritical gas
extraction processes and boiling in the range of approximately 30 °C to
180 °C. Composed primarily of aromatic, hydrogenated aromatic and
naphthenic compounds, their alkyl derivatives and alkanes with carbon
numbers predominantly in the range of C4 to C9. Nitrogen, sulfur and
oxygen-containing aromatic and hydrogenated aromatic compounds are
also present.)

Gasoline, coal solvent extn., hydrocracked naphtha;

648-151-00-7

302-691-7

94114-55-3

J

(Motor fuel produced by the reforming of the refined naphtha fraction of
the products of hydrocracking of coal extract or solution produced by the
liquid solvent extraction or supercritical gas extraction processes and
boiling in the range of approximately 30 °C to 180 °C. Composed
primarily of aromatic and naphthenic hydrocarbons, their alkyl deriva-
tives and alkyl hydrocarbons having carbon numbers in the range of C4
through C9.)

Distillates (coal), solvent extn., hydrocracked middle;

648-152-00-2

302-692-2

94114-56-4

J

(Distillate obtained from the hydrocracking of coal extract or solution
produced by the liquid solvent extraction or supercritical gas extraction
processes and boiling in the range of approximately 180 °C to 300 °C.
Composed primarily of two-ring aromatic, hydrogenated aromatic and
naphthenic compounds, their alkyl derivatives and alkanes having carbon
numbers predominantly in the range of C9 through C14. Nitrogen, sulfur
and oxygen-containing compounds are also present.)

Distillates (coal), solvent extn., hydrocracked hydrogenated middle;

648-153-00-8

302-693-8

94114-57-5

(Distillate from the hydrogenation of hydrocracked middle distillate from
coal extract or solution produced by the liquid solvent extraction or
supercritical gas extraction processes and boiling in the range of approxi-
mately 180 °C to 280 °C. Composed primarily of hydrogenated two-ring
carbon compounds and their alkyl derivatives having carbon numbers
predominantly in the range of C9 through C14.)

Light oil (coal), semi-coking process; Fresh oil

648-156-00-4

292-635-7

90641-11-5

(The volatile organic liquid condensed from the gas evolved in the low
temperature (less than 700 °C) destructive distillation of coal. Composed
primarily of C6-10 hydrocarbons.)

J

J

Extracts (petroleum), light naphthenic distillate solvent

649-001-00-3

265-102-1

64742-03-6

14.11.2006

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Official Journal of the European Union

C 276E/167

Substances

Index number

EC number

CAS number

Notes

Extracts (petroleum), heavy paraffinic distillate solvent

649-002-00-9

265-103-7

64742-04-7

Extracts (petroleum), light paraffinic distillate solvent

649-003-00-4

265-104-2

6472-05-8

Extracts (petroleum), heavy naphthenic distillate solvent

649-004-00-X

265-111-0

64742-11-6

Extracts (petroleum), light vacuum gas oil solvent

649-005-00-5

295-341-7

91995-78-7

Hydrocarbons C26-55, arom.-rich

649-006-00-0

307-753-7

97722-04-8

Residues (petroleum), atm. tower; Heavy fuel oil

649-008-00-1

265-045-2

64741-45-3

(A complex residuum from the atmospheric distillation of crude oil. It
consists of hydrocarbons having carbon numbers predominantly greater
than C20 and boiling above approximately 350 °C. This stream is likely to
contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic
hydrocarbons.)

Gas oils (petroleum), heavy vacuum; Heavy fuel oil

649-009-00-7

265-058-3

64741-57-7

(A complex combination of hydrocarbons produced by the vacuum distil-
lation of the residuum from atmospheric distillation of crude oil.
It
consists of hydrocarbons having carbon numbers predominantly in the
range of C20 through C50 and boiling in the range of approximately
350 °C to 600 °C. This stream is likely to contain 5 wt. % more of 4- to
6-membered condensed ring aromatic hydrocarbons.)

Distillates (petroleum), heavy catalytic cracked; Heavy fuel oil

649-010-00-2

265-063-0

64741-61-3

(A complex combination of hydrocarbons produced by the distillation of
products from a catalytic cracking process. It consists of hydrocarbons
having carbon numbers predominantly in the range of C15 through C35
and boiling in the range of approximately 260 °C to 500 °C. This stream
is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring
aromatic hydrocarbons.)

Clarified oils (petroleum), catalytic cracked; Heavy fuel oil

649-011-00-8

265-064-6

64741-62-4

(A complex combination of hydrocarbons produced as the residual frac-
tion from distillation of the products from a catalytic cracking process. It
consists of hydrocarbons having carbon numbers predominantly greater
than C20 and boiling above approximately 350 °C. This stream is likely to
contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic
hydrocarbons.)

Residues (petroleum), hydrocracked; Heavy fuel oil

649-012-00-3

265-076-1

64741-75-9

(A complex combination of hydrocarbons produced as the residual frac-
tion from distillation of the products of a hydrocracking process.
It
consists of hydrocarbons having carbon numbers predominantly greater
than C20 and boiling above approximately 350 °C.)

C 276E/168

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Residues (petroleum), thermal cracked; Heavy fuel oil

649-013-00-9

265-081-9

64741-80-6

(A complex combination of hydrocarbons produced as the residual frac-
tion from distillation of the product from a thermal cracking process. It
consists predominantly of unsaturated hydrocarbons having carbon
numbers predominantly greater than C20 and boiling above approximately
350 °C. This stream is likely to contain 5 wt. % or more of 4- to 6-
membered condensed ring aromatic hydrocarbons.)

Distillates (petroleum), heavy thermal cracked; Heavy fuel oil

649-014-00-4

265-082-4

64741-81-7

(A complex combination of hydrocarbons from the distillation of the
products from a thermal cracking process. It consists predominantly of
unsaturated hydrocarbons having carbon numbers predominantly in the
range of C15 through C36 and boiling in the range of approximately
260 °C to 480 °C. This stream is likely to contain 5 wt. % or more or 4-
to 6-membered condensed ring aromatic hydrocarbons.)

Gas oils (petroleum), hydrotreated vacuum; Heavy fuel oil

649-015-00-X

265-162-9

64742-59-2

(A complex combination of hydrocarbons obtained by treating a petro-
leum fraction with hydrogen in the presence of a catalyst. It consists of
hydrocarbons having carbon numbers predominantly in the range of C13
through C50 and boiling in the range of approximately 230 °C to 600 °C.
This stream is likely to contain 5 wt. % or more of 4- to 6-membered
condensed ring aromatic hydrocarbons.)

Residues (petroleum) hydrodesulfurised atmospheric tower; Heavy fuel oil

649-016-00-5

265-181-2

64742-78-5

(A complex combination of hydrocarbons obtained by treating an atmo-
spheric tower residuum with hydrogen in the presence of a catalyst under
conditions primarily to remove organic sulfur compounds. It consists of
hydrocarbons having carbon numbers predominantly greater than C20
and boiling above approximately 350 °C. This stream is likely to contain
5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocar-
bons.)

Gas oils (petroleum), hydrodesulfurised heavy vacuum; Heavy fuel oil

649-017-00-0

265-189-6

64742-86-5

(A complex combination of hydrocarbons obtained from a catalytic
hydrodesulfurisation process. It consists of hydrocarbons having carbon
numbers predominantly in the range of C20 through C50 and boiling in
the range of approximately 350 °C to 600 °C. This stream is likely to
contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic
hydrocarbons.)

Residues (petroleum), steam-cracked; Heavy fuel oil

649-018-00-6

265-193-8

64742-90-1

(A complex combination of hydrocarbons obtained as the residual frac-
tion from the distillation of the products of a steam cracking process
(including steam cracking to produce ethylene). It consists predominantly
of unsaturated hydrocarbons having carbon numbers predominantly
greater than C14 and boiling above approximately 260 °C. This stream is
likely to contain 5 wt. % or more of 4- to 6-membered condensed ring
aromatic hydrocarbons.)

14.11.2006

EN

Official Journal of the European Union

C 276E/169

Substances

Index number

EC number

CAS number

Notes

Residues (petroleum), atmospheric; Heavy fuel oil

649-019-00-1

269-777-3

68333-22-2

(A complex residuum from atmospheric distillation of crude oil.
It
consists of hydrocarbons having carbon numbers predominantly greater
than C11 and boiling above approximately 200 °C. This stream is likely to
contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic
hydrocarbons.)

Clarified oils (petroleum), hydrodesulfurised catalytic cracked; Heavy fuel
oil

(A complex combination of hydrocarbons obtained by treating catalytic
cracked clarified oil with hydrogen to convert organic sulfur to hydrogen
sulfide which is removed.
It consists of hydrocarbons having carbon
numbers predominantly greater than C20 and boiling above approximately
350 °C. This stream is likely to contain 5 wt. % or more of 4- to 6-
membered condensed ring aromatic hydrocarbons.)

Distillates (petroleum), hydrodesulfurised intermediate catalytic cracked;
Heavy fuel oil

(A complex combination of hydrocarbons obtained by treating inter-
mediate catalytic cracked distillates with hydrogen to convert organic
sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons
having carbon numbers predominantly in the range of C11 through C30
and boiling in the range of approximately 205 °C to 450 °C. It contains a
relatively large proportion of tricyclic aromatic hydrocarbons.)

Distillates (petroleum), hydrodesulfurised heavy catalytic cracked; Heavy
fuel oil

(A complex combination of hydrocarbons obtained by treatment of heavy
catalytic cracked distillates with hydrogen to convert organic sulfur to
hydrogen sulfide which is removed. It consists of hydrocarbons having
carbon numbers predominantly in the range of C15 through C35 and
boiling in the range of approximately 260 °C to 500 °C. This stream is
likely to contain 5 wt. % or more of 4- to 6-membered condensed ring
aromatic hydrocarbons.)

649-020-00-7

269-782-0

68333-26-6

649-021-00-2

269-783-6

68333-27-7

649-022-00-8

269-784-1

68333-28-8

Fuel oil, residues-straight-run gas oils, high-sulfur; Heavy fuel oil

649-023-00-3

270-674-0

68476-32-4

Fuel oil, residual; Heavy fuel oil

649-024-00-9

270-675-6

68476-33-5

(The liquid product from various refinery streams, usually residues. The
composition is complex and varies with the source of the crude oil.)

Residues (petroleum), catalytic reformer fractionator residue distn.; Heavy
fuel oil

(A complex residuum from the distillation of catalytic reformer fractio-
nator residue. It boils above approximately 399 °C.)

649-025-00-4

270-792-2

68478-13-7

C 276E/170

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Residues (petroleum), heavy coker gas oil and vacuum gas oil; Heavy fuel
oil

(A complex combination of hydrocarbons produced as the residual frac-
tion from the distillation of heavy coker gas oil and vacuum gas oil. It
predominantly consists of hydrocarbons having carbon numbers predo-
minantly greater than C13 and boiling above approximately 230 °C.)

649-026-00-X

270-796-4

68478-17-1

Residues (petroleum), heavy coker and light vacuum; Heavy fuel oil

649-027-00-5

270-983-0

68512-61-8

(A complex combination of hydrocarbons produced as the residual frac-
tion from the distillation of heavy coker gas oil and light vacuum gas oil.
It consists predominantly of hydrocarbons having carbon numbers predo-
minantly greater than C13 and boiling above approximately 230 °C.)

Residues (petroleum), light vacuum; Heavy fuel oil

649-028-00-0

270-984-6

68512-62-9

(A complex residuum from the vacuum distillation of the residuum from
It consists of hydrocarbons
the atmospheric distillation of crude oil.
having carbon numbers predominantly greater than C13 and boiling
above approximately 230 °C.)

Residues (petroleum), steam-cracked light; Heavy fuel oil

649-029-00-6

271-013-9

68513-69-9

(A complex residuum from the distillation of the products from a steam-
cracking process. It consists predominantly of aromatic and unsaturated
hydrocarbons having carbon numbers greater than C7 and boiling in the
range of approximately 101 °C to 555 °C.)

Fuel oil, No 6; Heavy fuel oil

649-030-00-1

271-384-7

68553-00-4

(A distillate oil having a minimum viscosity of 197 10-6 m2·s-1 at 37,7 °C
to a maximum of 197 10-5 m2·s-1 at 37,7 °C.)

Residues (petroleum), topping plant, low-sulfur; Heavy fuel oil

649-031-00-7

271-763-7

68607-30-7

(A low-sulfur complex combination of hydrocarbons produced as the resi-
dual fraction from the topping plant distillation of crude oil. It is the resi-
duum after the straight-run gasoline cut, kerosene cut and gas oil cut
have been removed.)

Gas oils (petroleum), heavy atmospheric; Heavy fuel oil

649-032-00-2

272-184-2

68783-08-4

(A complex combination of hydrocarbons obtained by the distillation of
crude oil. It consists of hydrocarbons having carbon numbers predomi-
nantly in the range of C7 through C35 and boiling in the range of approxi-
mately 121 °C to 510 °C.)

Residues
Heavy fuel oil

(petroleum),

coker

scrubber, Condensed-ring-arom.-contg.;

649-033-00-8

272-187-9

68783-13-1

(A very complex combination of hydrocarbons produced as the residual
fraction from the distillation of vacuum residuum and the products from
a thermal cracking process. It consists predominantly of hydrocarbons
having carbon numbers predominantly greater than C20 and boiling
above approximately 350 °C. This stream is likely to contain 5 wt. % or
more of 4- to 6-membered condensed ring aromatic hydrocarbons.)

14.11.2006

EN

Official Journal of the European Union

C 276E/171

Substances

Index number

EC number

CAS number

Notes

Distillates (petroleum), petroleum residues vacuum; Heavy fuel oil

649-034-00-3

273-263-4

68955-27-1

(A complex combination of hydrocarbons produced by the vacuum distil-
lation of the residuum from the atmospheric distillation of crude oil.)

Residues (petroleum), steam-cracked, resinous; Heavy fuel oil

649-035-00-9

273-272-3

68955-36-2

(A complex residuum from the distillation of steam-cracked petroleum
residues.)

Distillates (petroleum), intermediate vacuum; Heavy fuel oil

649-036-00-4

274-683-0

70592-76-6

(A complex combination of hydrocarbons produced by the vacuum distil-
It
lation of the residuum from atmospheric distillation of crude oil.
consists of hydrocarbons having carbon numbers predominantly in the
range of C14 through C42 and boiling in the range of approximately
250 °C to 545 °C. This stream is likely to contain 5 wt. % or more of 4-
to 6-membered condensed ring aromatic hydrocarbons.)

Distillates (petroleum), light vacuum; Heavy fuel oil

649-037-00-X

247-684-6

70592-77-7

(A complex combination of hydrocarbons produced by the vacuum distil-
It
lation of the residuum from atmospheric distillation of crude oil.
consists of hydrocarbons having carbon numbers predominantly in the
range of C11 through C35 and boiling in the range of approximately
250 °C to 545 °C.)

Distillates (petroleum), vacuum; Heavy fuel oil

649-038-00-5

274-685-1

70592-78-8

(A complex combination of hydrocarbons produced by the vacuum distil-
lation of the residuum from atmospheric distillation of crude oil.
It
consists of hydrocarbons having numbers predominantly in the range of
C15 through C50 and boiling in the range of approximately 270 °C to
600 °C. This stream is likely to contain 5 wt. % or more of 4- to 6-
membered condensed ring aromatic hydrocarbons.)

Gas oils (petroleum), hydrodesulphurised coker heavy vacuum; Heavy fuel
oil

(A complex combination of hydrocarbons obtained by hydrodesulphurisa-
tion of heavy coker distillate stocks. It consists predominantly of hydro-
carbons having carbon numbers predominantly in the range C18 to C44
and boiling in the range of approximately 304 °C to 548 °C. Likely to
contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic
hydrocarbons.)

649-039-00-0

285-555-9

85117-03-9

Residues (petroleum), steam-cracked, distillates; Heavy fuel oil

649-040-00-6

292-657-7

90669-75-3

(A complex combination of hydrocarbons obtained during the production
of refined petroleum tar by the distillation of steam cracked tar. It consists
predominantly of aromatic and other hydrocarbons and organic sulfur
compounds.)

Residues (petroleum), vacuum, light; Heavy fuel oil

649-041-00-1

292-658-2

90669-76-4

(A complex residuum from the vacuum distillation of the residuum from
atmospheric distillation of crude oil. It consists predominantly of hydro-
carbons having carbon numbers predominantly greater than C24 and
boiling above approximately 390 °C.)

C 276E/172

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Fuel oil, heavy, high-sulphur; Heavy fuel oil

649-042-00-7

295-396-7

92045-14-2

(A complex combination of hydrocarbons obtained by the distillation of
crude petroleum. It consists predominantly of aliphatic, aromatic and
cycloaliphatic hydrocarbons having carbon numbers predominantly
higher than C25 and boiling above approximately 400 °C.)

Residues (petroleum), catalytic cracking; Heavy fuel oil

649-043-00-2

295-511-0

92061-97-7

(A complex combination of hydrocarbons produced as the residual frac-
tion from the distillation of
the products from a catalytic cracking
process.
It consists predominantly of hydrocarbons having carbon
numbers predominantly greater than C11 and boiling above approximately
200 °C.)

Distillates (petroleum), intermediate catalytic cracked, thermally degraded;
Heavy fuel oil

(A complex combination of hydrocarbons produced by the distillation of
products from a catalytic cracking process which has been used as a heat
transfer fluid. It consists predominantly of hydrocarbons boiling in the
range of approximately 220 °C to 450 °C. This stream is likely to contain
organic sulfur compounds.)

649-044-00-8

295-990-6

92201-59-7

Residual oils (petroleum); Heavy fuel oil

649-045-00-3

298-754-0

93821-66-0

(A complex combination of hydrocarbons, sulfur compounds and metal-
containing organic compounds obtained as the residue from refinery frac-
tionation cracking processes. It produces a finished oil with a viscosity
above 2 10-6 m2·s-1 at 100 °C.)

Residues, steam cracked, thermally treated; Heavy fuel oil

649-046-00-9

308-733-0

98219-64-8

(A complex combination of hydrocarbons obtained by the treatment and
distillation of raw steam-cracked naphtha. It consists predominantly of
unsaturated hydrocarbons boiling in the range above approximately
180 °C.)

Distillates (petroleum), hydrodesulphurised full-range middle; Heavy fuel
oil

(A complex combination of hydrocarbons obtained by treating a petro-
leum stock with hydrogen. It consists predominantly of hydrocarbons
having carbon numbers predominantly in the range of C9 through C25
and boiling in the range of approximately 150 °C to 400 °C.)

649-047-00-4

309-863-0

101316-57-8

Residues (petroleum), catalytic reformer fractionator; Heavy fuel oil

649-048-00-X

265-069-3

64741-67-9

(A complex combination of hydrocarbons produced as the residual frac-
tion from distillation of the product from a catalytic reforming process. It
consists of predominantly aromatic hydrocarbons having carbon numbers
predominantly in the range of C10 through C25 and boiling in the range of
approximately 160 °C to 400 °C. This stream is likely to contain 5 wt. %
or more of 4- or 6-membered condensed ring aromatic hydrocarbons.)

14.11.2006

EN

Official Journal of the European Union

C 276E/173

Substances

Index number

EC number

CAS number

Notes

Petroleum; Crude oil

649-049-00-5

232-298-5

8002-05-9

(A complex combination of hydrocarbons. It consists predominantly of
aliphatic, alicyclic and aromatic hydrocarbons. It may also contain small
amounts of nitrogen, oxygen and sulfur compounds. This category
encompasses light, medium, and heavy petroleums, as well as the oils
extended from tar sands. Hydrocarbonaceous materials requiring major
chemical changes for their recovery or conversion to petroleum refinery
feedstocks such as crude shale oils; upgraded shale oils and liquid coal
fuels are not included in this definition.)

Gases (petroleum), catalytic cracked naphtha depropanizer overhead, C3-
rich acid-free; Petroleum gas

(A complex combination of hydrocarbons obtained from fractionation of
catalytic cracked hydrocarbons and treated to remove acidic impurities. It
consists of hydrocarbons having carbon numbers in the range of C2
through C4, predominantly C3.)

649-062-00-6

270-755-0

68477-73-6

K

Gases (petroleum), catalytic cracker; Petroleum gas

649-063-00-1

270-756-6

68477-74-7

K

(A complex combination of hydrocarbons produced by the distillation of
the products from a catalytic cracking process. It consists predominantly
of aliphatic hydrocarbons having carbon numbers predominantly in the
range of C1 through C6.)

Gases (petroleum), catalytic cracker, C1-5-rich; Petroleum gas
(A complex combination of hydrocarbons produced by the distillation of
products from a catalytic cracking process. It consists of aliphatic hydro-
carbons having carbon numbers in the range of C1 through C6, predomi-
nantly C1 through C5.)

Gases (petroleum), catalytic polymd. naphtha stabiliser overhead, C2-4-
rich; Petroleum gas

(A complex combination of hydrocarbons obtained from the fractionation
It consists of aliphatic
stabilisation of catalytic polymerised naphtha.
hydrocarbons having carbon numbers in the range of C2 through C6,
predominantly C2 through C4.)

Gases (petroleum), catalytic reformer, C1-4-rich; Petroleum gas
(A complex combination of hydrocarbons produced by distillation of
products from a catalytic reforming process. It consists of hydrocarbons
having carbon numbers in the range of C1 through C6, predominantly C1
through C4.)

Gases (petroleum), C3-5 olefinic-paraffinic alkylation feed; Petroleum gas
(A complex combination of olefinic and paraffinic hydrocarbons having
carbon numbers in the range of C3 through C5 which are used as alkyla-
tion feed. Ambient temperatures normally exceed the critical temperature
of these combinations.)

Gases (petroleum), C4-rich; Petroleum gas
(A complex combination of hydrocarbons produced by distillation of
products from a catalytic fractionation process. It consists of aliphatic
hydrocarbons having carbon numbers in the range of C3 through C5,
predominantly C4.)

649-064-00-7

270-757-1

68477-75-8

K

649-065-00-2

270-758-7

68477-76-9

K

649-066-00-8

270-760-8

68477-79-2

K

649-067-00-3

270-765-5

68477-83-8

K

649-068-00-9

270-767-6

68477-85-0

K

C 276E/174

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Gases (petroleum), deethaniser overheads; Petroleum gas

649-069-00-4

270-768-1

68477-86-1

K

(A complex combination of hydrocarbons produced from distillation of
the gas and gasoline fractions from the catalytic cracking process.
It
contains predominantly ethane and ethylene.)

Gases (petroleum), deisobutaniser tower overheads; Petroleum gas

649-070-00-X

270-769-7

68477-87-2

K

(A complex combination of hydrocarbons produced by the atmospheric
distillation of a butane-butylene stream. It consists of aliphatic hydrocar-
bons having carbon numbers predominantly in the range of C3 through
C4.)

Gases (petroleum), depropaniser dry, propene-rich; Petroleum gas

649-071-00-5

270-772-3

68477-90-7

K

(A complex combination of hydrocarbons produced by the distillation of
products from the gas and gasoline fractions of a catalytic cracking
process. It consists predominantly of propylene with some ethane and
propane.)

Gases (petroleum), depropaniser overheads; Petroleum gas

649-072-00-0

270-773-9

68477-91-8

K

(A complex combination of hydrocarbons produced by distillation of
products from the gas and gasoline fractions of a catalytic cracking
process. It consists of aliphatic hydrocarbons having carbon numbers
predominantly in the range of C2 through C4.)

Gases (petroleum), gas recovery plant depropaniser overheads; Petroleum
gas

(A complex combination of hydrocarbons obtained by fractionation of
miscellaneous hydrocarbon streams. It consists predominantly of hydro-
carbons having carbon numbers in the range of C1 through C4, predomi-
nantly propane.)

649-073-00-6

270-777-0

68477-94-1

K

Gases (petroleum), Girbatol unit feed; Petroleum gas

649-074-00-1

270-778-6

68477-95-2

K

(A complex combination of hydrocarbons that is used as the feed into the
Girbatol unit to remove hydrogen sulfide. It consists of aliphatic hydro-
carbons having carbon numbers predominantly in the range of C2
through C4.)

Gases (petroleum),
sulfide-free; Petroleum gas

isomerised naphtha fractionator, C4-rich, hydrogen

649-075-00-7

270-782-8

68477-99-6

649-076-00-2

270-802-5

68478-21-7

K

K

Tail gas (petroleum), catalytic cracked clarified oil and thermal cracked
vacuum residue fractionation reflux drum; Petroleum gas

(A complex combination of hydrocarbons obtained from fractionation of
catalytic cracked clarified oil and thermal cracked vacuum residue.
It
consists predominantly of hydrocarbons having carbon numbers predo-
minantly in the range of C1 through C6.)

Tail gas (petroleum), catalytic cracked naphtha stabilisation absorber;
Petroleum gas

(A complex combination of hydrocarbons obtained from the stabilisation
of catalytic cracked naphtha. It consists predominantly of hydrocarbons
having carbon numbers predominantly in the range of C1 through C6.)

649-077-00-8

270-803-0

68478-22-8

K

14.11.2006

EN

Official Journal of the European Union

C 276E/175

Substances

Index number

EC number

CAS number

Notes

Tail gas (petroleum), catalytic cracker, catalytic reformer and hydrodesul-
furiser combined fractionater; Petroleum gas

(A complex combination of hydrocarbons obtained from the fractionation
of products from catalytic cracking, catalytic reforming and hydrodesul-
furising processes treated to remove acidic impurities. It consists predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of C1 through C5.)

Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser;
Petroleum gas

(A complex combination of hydrocarbons obtained from the fractionation
stabilisation of catalytic reformed naphtha. It consists predominantly of
hydrocarbons having carbon numbers predominantly in the range of C1
through C4.)

Tail gas (petroleum), saturate gas plant mixed stream, C4-rich; Petroleum
gas

(A complex combination of hydrocarbons obtained from the fractionation
stabilisation of straight-run naphtha, distillation tail gas and catalytic
reformed naphtha stabiliser tail gas. It consists of hydrocarbons having
carbon numbers in the range of C3 through C6, predominantly butane
and isobutane.)

Tail gas (petroleum), saturate gas recovery plant, C1-2-rich; Petroleum gas
(A complex combination of hydrocarbons obtained from fractionation of
distillate tail gas, straight-run naphtha, catalytic reformed naphtha stabi-
liser tail gas. It consists predominantly of hydrocarbons having carbon
numbers in the range of C1 through C5, predominantly methane and
ethane.)

649-078-00-3

270-804-6

68478-24-0

K

649-079-00-9

270-806-7

68478-26-2

K

649-080-00-4

270-813-5

68478-32-0

K

649-081-00-X

270-814-0

68478-33-1

K

Tail gas (petroleum), vacuum residues thermal cracker; Petroleum gas

649-082-00-5

270-815-6

68478-34-2

K

(A complex combination of hydrocarbons obtained from the thermal
cracking of vacuum residues. It consists of hydrocarbons having carbon
numbers predominantly in the range of C1 through C5.)

Hydrocarbons, C3-4-rich, petroleum distillate; Petroleum gas
(A complex combination of hydrocarbons produced by distillation and
condensation of crude oil. It consists of hydrocarbons having carbon
numbers in the range of C3 through C5, predominantly C3 through C4.)

649-083-00-0

270-990-9

68512-91-4

K

Gases (petroleum), full-range straight-run naphtha dehexaniser off; Petro-
leum gas

(A complex combination of hydrocarbons obtained by the fractionation
of the full-range straight-run naphtha. It consists of hydrocarbons having
carbon numbers predominantly in the range of C2 through C6.)

Gases (petroleum), hydrocracking depropaniser off, hydrocarbon-rich;
Petroleum gas

(A complex combination of hydrocarbon produced by the distillation of
products from a hydrocracking process.
It consists predominantly of
hydrocarbons having carbon numbers predominantly in the range of C1
through C4. It may also contain small amounts of hydrogen and hydrogen
sulfide.)

649-084-00-6

271-000-8

68513-15-5

K

649-085-00-1

271-001-3

68513-16-6

K

C 276E/176

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Gases (petroleum), light straight-run naphtha stabiliser off; Petroleum gas

649-086-00-7

271-002-9

68513-17-7

K

(A complex combination of hydrocarbons obtained by the stabilisation of
light straight-run naphtha. It consists of saturated aliphatic hydrocarbons
having carbon numbers predominantly in the range of C2 through C6.)

Residues (petroleum), alkylation splitter, C4-rich; Petroleum gas
(A complex residuum from the distillation of streams from various
refinery operations. It consists of hydrocarbons having carbon numbers
in the range of C4 through C5, predominantly butane, and boiling in the
range of approximately -11,7 °C to 27,8 °C.)

Hydrocarbons, C1-4, sweetened; Petroleum gas
(A complex combination of hydrocarbons obtained by subjecting hydro-
carbon gases to a sweetening process to convert mercaptans or to remove
acidic impurities.
It consists of hydrocarbons having carbon numbers
predominantly in the range of C1 through C4 and boiling in the range of
approximately -164 °C to -0,5 °C.)

649-087-00-2

271-010-2

68513-66-6

K

649-089-00-3

271-038-5

68514-36-3

K

Hydrocarbons, C1-3; Petroleum gas
(A complex combination of hydrocarbons having carbon numbers predo-
minantly in the range of C1 through C3 and boiling in the range of
approximately -164 °C to -42 °C.)

649-090-00-9

271-259-7

68527-16-2

K

Hydrocarbons, C1-4, debutaniser fraction; Petroleum gas

649-091-00-4

271-261-8

68527-19-5

Gases (petroleum), C1-5, wet; Petroleum gas
(A complex combination of hydrocarbons produced by the distillation of
crude oil and/or the cracking of tower gas oil. It consists of hydrocarbons
having carbon numbers predominantly in the range of C1 through C5.)

649-092-00-X

271-624-0

68602-83-5

Hydrocarbons, C2-4; Petroleum gas

649-093-00-5

271-734-9

68606-25-7

Hydrocarbons, C3; Petroleum gas

649-094-00-0

271-735-4

68606-26-8

Gases (petroleum), alkylation feed; Petroleum gas

649-095-00-6

271-737-5

68606-27-9

(A complex combination of hydrocarbons produced by the catalytic
cracking of gas oil. It consists of hydrocarbons having carbon numbers
predominantly in the range of C3 through C4.)

K

K

K

K

K

Gases (petroleum), depropaniser bottoms fractionation off; Petroleum gas

649-096-00-1

271-742-2

68606-34-8

K

(A complex combination of hydrocarbons obtained from the fractionation
of depropaniser bottoms. It consists predominantly of butane, isobutane
and butadiene.)

Gases (petroleum), refinery blend; Petroleum gas

649-097-00-7

272-183-7

68783-07-3

K

(A complex combination obtained from various processes. It consists of
hydrogen, hydrogen sulfide and hydrocarbons having carbon numbers
predominantly in the range of C1 through C5.)

14.11.2006

EN

Official Journal of the European Union

C 276E/177

Substances

Index number

EC number

CAS number

Notes

Gases (petroleum), catalytic cracking; Petroleum gas

649-098-00-2

272-203-4

68783-64-2

K

(A complex combination of hydrocarbons produced by the distillation of
the products from a catalytic cracking process. It consists predominantly
of hydrocarbons having carbon numbers predominantly in the range of
C3 through C5.)

Gases (petroleum), C2-4, sweetened; Petroleum gas
(A complex combination of hydrocarbons obtained by subjecting a petro-
leum distillate to a sweetening process to convert mercaptans or to
remove acidic impurities. It consists predominantly of saturated and unsa-
turated hydrocarbons having carbon numbers predominantly in the range
of C2 through C4 and boiling in the range of approximately -51 °C to -
34 °C.)

649-099-00-8

272-205-5

68783-65-3

K

Gases (petroleum), crude oil fractionation off; Petroleum gas

649-100-00-1

272-871-7

68918-99-0

K

(A complex combination of hydrocarbons produced by the fractionation
of crude oil. It consists of saturated aliphatic hydrocarbons having carbon
numbers predominantly in the range of C1 through C5.)

Gases (petroleum), dehexaniser off; Petroleum gas

649-101-00-7

272-872-2

68919-00-6

K

(A complex combination of hydrocarbons obtained by the fractionation
of combined naphtha streams. It consists of saturated aliphatic hydrocar-
bons having carbon numbers predominantly in the range of C1 through
C5.)

Gases (petroleum), light straight run gasoline fractionation stabiliser off;
Petroleum gas

(A complex combination of hydrocarbons obtained by the fractionation
of light straight-run gasoline. It consists of saturated aliphatic hydrocar-
bons having carbon numbers predominantly in the range of C1 through
C5.)

Gases (petroleum), naphtha unifiner desulfurisation stripper off; Petroleum
gas

(A complex combination of hydrocarbons produced by a naphtha
unifiner desulfurisation process and stripped from the naphtha product. It
consists of saturated aliphatic hydrocarbons having carbon numbers
predominantly in the range of C1 through C4.)

Gases (petroleum), straight-run naphtha catalytic reforming off; Petroleum
gas

(A complex combination of hydrocarbons obtained by the catalytic
reforming of straight-run naphtha and fractionation of the total effluent.
It consists of methane, ethane, and propane.)

Gases (petroleum), fluidised catalytic cracker splitter overheads; Petroleum
gas

(A complex combination of hydrocarbons produced by the fractionation
of the charge to the C3-C4 splitter. It consists predominantly of C3 hydro-
carbons.)

649-102-00-2

272-878-5

68919-05-1

K

649-103-00-8

272-879-0

68919-06-2

K

649-104-00-3

272-882-7

68919-09-5

K

649-105-00-9

272-893-7

68919-20-0

K

C 276E/178

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Gases (petroleum), straight-run stabiliser off; Petroleum gas

649-106-00-4

272-883-2

68919-10-8

K

(A complex combination of hydrocarbons obtained from the fractionation
of the liquid from the first tower used in the distillation of crude oil. It
consists of saturated aliphatic hydrocarbons having carbon numbers
predominantly in the range of C1 through C4.)

Gases (petroleum), catalytic cracked naphtha debutaniser; Petroleum gas

649-107-00-X

273-169-3

68952-76-1

K

(A complex combination of hydrocarbons obtained from fractionation of
It consists of hydrocarbons having carbon
catalytic cracked naphtha.
numbers predominantly in the range of C1 through C4.)

Tail gas (petroleum), catalytic cracked distillate and naphtha stabiliser;
Petroleum gas

(A complex combination of hydrocarbons obtained by the fractionation
of catalytic cracked naphtha and distillate. It consists predominantly of
hydrocarbons having carbon numbers predominantly in the range of C1
through C4.)

649-108-00-5

273-170-9

68952-77-2

K

Tail gas (petroleum),
absorber; Petroleum gas

thermal-cracked distillate, gas oil and naphtha

649-109-00-0

273-175-6

68952-81-8

K

(A complex combination of hydrocarbons obtained from the separation
of thermal-cracked distillates, naphtha and gas oil. It consists predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of C1 through C6.)

Tail gas (petroleum), thermal cracked hydrocarbon fractionation stabiliser,
petroleum coking; Petroleum gas

(A complex combination of hydrocarbons obtained from the fractionation
stabilisation of thermal cracked hydrocarbons from a petroleum coking
process. It consists of hydrocarbons having carbon numbers predomi-
nantly in the range of C1 through C6.)

649-110-00-6

273-176-1

68952-82-9

K

Gases (petroleum, light steam-cracked, butadiene conc.; Petroleum gas

649-111-00-1

273-265-5

68955-28-2

K

(A complex combination of hydrocarbons produced by the distillation of
products from a thermal cracking process. It consists of hydrocarbons
having a carbon number predominantly of C4.)

Gases (petroleum), straight-run naphtha catalytic reformer stabiliser over-
head; Petroleum gas

(A complex combination of hydrocarbons obtained by the catalytic
the total
reforming of straight-run naphtha and the fractionation of
effluent. It consists of saturated aliphatic hydrocarbons having carbon
numbers predominantly in the range of C2 through C4.)

649-112-00-7

273-270-2

68955-34-0

K

Hydrocarbons, C4; Petroleum gas

649-113-00-2

289-339-5

87741-01-3

Alkanes, C1-4, C3-rich; Petroleum gas

649-114-00-8

292-456-4

90622-55-2

K

K

14.11.2006

EN

Official Journal of the European Union

C 276E/179

Substances

Index number

EC number

CAS number

Notes

Gases (petroleum), steam-cracker C3-rich; Petroleum gas
(A complex combination of hydrocarbons produced by the distillation of
products from a steam cracking process. It consists predominantly of
propylene with some propane and boils in the range of approximately -
70 °C to 0 °C.)

Hydrocarbons, C4, steam-cracker distillate; Petroleum gas
(A complex combination of hydrocarbons produced by the distillation of
the products of a steam cracking process. It consists predominantly of
hydrocarbons having a carbon number of C4, predominantly 1-butene
and 2-butene, containing also butane and isobutene and boiling in the
range of approximately -12 °C to 5 °C.)

Petroleum gases, liquefied, sweetened, C4 fraction; Petroleum gas
(A complex combination of hydrocarbons obtained by subjecting a liqui-
fied petroleum gas mix to a sweetening process to oxidise mercaptans or
to remove acidic impurities. It consists predominantly of C4 saturated and
unsaturated hydrocarbons.)

649-115-00-3

295-404-9

92045-22-2

K

649-116-00-9

295-405-4

92045-23-3

K

649-117-00-4

295-463-0

92045-80-2

K

Hydrocarbons, C4, 1,3-butadiene-and isobutene-free; Petroleum gas

649-118-00-X

306-004-1

95465-89-7

Raffinates (petroleum), steam-cracked C4 fraction cuprous ammonium
acetate extn., C3-5 and C3-5 unsatd., butadiene-free; Petroleum gas

649-119-00-5

307-769-4

97722-19-5

Gases (petroleum), amine system feed; Refinery gas

649-120-00-0

270-746-1

68477-65-6

(The feed gas to the amine system for removal of hydrogen sulphide. It
consists primarily of hydrogen. Carbon monoxide, carbon dioxide,
hydrogen sulfide and aliphatic hydrocarbons having carbon numbers
predominantly in the range of C1 through C5 may also be present.)

K

K

K

Gases (petroleum), benzene unit hydrodesulphuriser off; Refinery gas

649-121-00-6

270-747-7

68477-66-7

K

It consists primarily of
(Off gases produced by the benzene unit.
hydrogen. Carbon monoxide and hydrocarbons having carbon numbers
predominantly in the range of C1 through C6, including benzene, may
also be present.)

Gases (petroleum), benzene unit recycle, hydrogen-rich; Refinery gas

649-122-00-1

270-748-2

68477-67-8

K

(A complex combination of hydrocarbons obtained by recycling the gases
of the benzene unit. It consists primarily of hydrogen with various small
amounts of carbon monoxide and hydrocarbons having carbon numbers
in the range of C1 through C6.)

Gases (petroleum), blend oil, hydrogen-nitrogen-rich; Refinery gas

649-123-00-7

270-749-8

68477-68-9

K

(A complex combination of hydrocarbons obtained by distillation of a
blend oil. It consists primarily of hydrogen and nitrogen with various
small amounts of carbon monoxide, carbon dioxide, and aliphatic hydro-
carbons having carbon numbers predominantly in the range of C1
through C5.)

C 276E/180

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

(petroleum),

Gases
Refinery gas

catalytic

reformed naphtha

stripper overheads;

649-124-00-2

270-759-2

68477-77-0

K

(A complex combination of hydrocarbons obtained from stabilisation of
catalytic reformed naphtha. It consists of hydrogen and saturated hydro-
carbons having carbon numbers predominantly in the range of C1
through C4.)

Gases (petroleum), C6-8 catalytic reformer recycle; Refinery gas
(A complex combination of hydrocarbons produced by distillation of
products from catalytic reforming of C6-C8 feed and recycled to conserve
hydrogen. It consists primarily of hydrogen. It may also contain various
small amounts of carbon monoxide, carbon dioxide, nitrogen, and hydro-
carbons having carbon numbers predominantly in the range of C1
through C6.)

Gases (petroleum), C6-8 catalytic reformer; Refinery gas
(A complex combination of hydrocarbons produced by distillation of
products from catalytic reforming of C6-C8 feed. It consists of hydrocar-
through C5 and
bons having carbon numbers in the range of C1
hydrogen.)

649-125-00-8

270-761-3

68477-80-5

K

649-126-00-3

270-762-9

68477-81-6

K

Gases (petroleum), C6-8 catalytic reformer recycle, hydrogen-rich; Refinery
gas

649-127-00-9

270-763-4

68477-82-7

K

Gases (petroleum), C2-return stream; Refinery gas
(A complex combination of hydrocarbons obtained by the extraction of
hydrogen from a gas stream which consists primarily of hydrogen with
small amounts of nitrogen, carbon monoxide, methane, ethane, and ethy-
lene. It contains predominantly hydrocarbons such as methane, ethane,
and ethylene with small amounts of hydrogen, nitrogen and carbon
monoxide.)

649-128-00-4

270-766-0

68477-84-9

K

Gases (petroleum), dry sour, gas-concn.-unit-off; Refinery gas

649-129-00-X

270-774-4

68477-92-9

K

(The complex combination of dry gases from a gas concentration unit. It
consists of hydrogen, hydrogen sulphide and hydrocarbons having carbon
numbers predominantly in the range of C1 through C3.)

Gases (petroleum), gas concn. reabsorber distn.; Refinery gas

649-130-00-5

270-776-5

68477-93-0

K

(A complex combination of hydrocarbons produced by distillation of
products from combined gas streams in a gas concentration reabsorber. It
consists predominantly of hydrogen, carbon monoxide, carbon dioxide,
nitrogen, hydrogen sulphide and hydrocarbons having carbon numbers in
the range of C1 through C3.)

Gases (petroleum), hydrogen absorber off; Refinery gas

649-131-00-0

270-779-1

68477-96-3

K

(A complex combination obtained by absorbing hydrogen from a
It consists of hydrogen, carbon monoxide,
hydrogen rich stream.
nitrogen, and methane with small amounts of C2 hydrocarbons.)

14.11.2006

EN

Official Journal of the European Union

C 276E/181

Substances

Index number

EC number

CAS number

Notes

Gases (petroleum), hydrogen-rich; Refinery gas

649-132-00-6

270-780-7

68477-97-4

K

(A complex combination separated as a gas from hydrocarbon gases by
chilling. It consists primarily of hydrogen with various small amounts of
carbon monoxide, nitrogen, methane, and C2 hydrocarbons.)

Gases (petroleum), hydrotreater blend oil recycle, hydrogen-nitrogen-rich;
Refinery gas

(A complex combination obtained from recycled hydrotreated blend oil.
It consists primarily of hydrogen and nitrogen with various small
amounts of carbon monoxide, carbon dioxide and hydrocarbons having
carbon numbers predominantly in the range of C1 through C5.)

649-133-00-1

270-781-2

68477-98-5

K

Gases (petroleum), recycle, hydrogen-rich; Refinery gas

649-134-00-7

270-783-3

68478-00-2

K

(A complex combination obtained from recycled reactor gases. It consists
primarily of hydrogen with various small amounts of carbon monoxide,
carbon dioxide, nitrogen, hydrogen sulphide, and saturated aliphatic
hydrocarbons having carbon numbers in the range of C1 through C5.)

Gases (petroleum), reformer make-up, hydrogen-rich; Refinery gas

649-135-00-2

270-784-9

68478-01-3

K

(A complex combination obtained from the reformers.
It consists
primarily of hydrogen with various small amounts of carbon monoxide
and aliphatic hydrocarbons having carbon numbers predominantly in the
range of C1 through C5.)

Gases (petroleum), reforming hydrotreater; Refinery gas

649-136-00-8

270-785-4

68478-02-4

K

(A complex combination obtained from the reforming hydrotreating
process. It consists primarily of hydrogen, methane, and ethane with
various small amounts of hydrogen sulphide and aliphatic hydrocarbons
having carbon numbers predominantly in the range C3 through C5.)

(petroleum),

Gases
Refinery gas

reforming hydrotreater, hydrogen-methane-rich;

649-137-00-3

270-787-5

68478-03-5

K

(A complex combination obtained from the reforming hydrotreating
process. It consists primarily of hydrogen and methane with various small
amounts of carbon monoxide, carbon dioxide, nitrogen and saturated
aliphatic hydrocarbons having carbon numbers predominantly in the
range of C2 through C5.)

(petroleum),

Gases
Refinery gas

reforming hydrotreater make-up, hydrogen-rich;

649-138-00-9

270-788-0

68478-04-6

K

(A complex combination obtained from the reforming hydrotreating
process. It consists primarily of hydrogen with various small amounts of
carbon monoxide and aliphatic hydrocarbons having carbon numbers
predominantly in the range of C1 through C5.)

Gases (petroleum), thermal cracking distn.; Refinery gas

649-139-00-4

270-789-6

68478-05-7

K

(A complex combination produced by distillation of products from a
thermal cracking process. It consists of hydrogen, hydrogen sulphide,
carbon monoxide, carbon dioxide and hydrocarbons having carbon
numbers predominantly in the range of C1 through C6.)

C 276E/182

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Tail gas (petroleum), catalytic cracker refractionation absorber; Refinery
gas

(A complex combination of hydrocarbons obtained from refractionation
of products from a catalytic cracking process. It consists of hydrogen and
hydrocarbons having carbon numbers predominantly in the range of C1
through C3.)

649-140-00-X

270-805-1

68478-25-1

K

Tail gas (petroleum), catalytic reformed naphtha separator; Refinery gas

649-141-00-5

270-807-2

68478-27-3

K

(A complex combination of hydrocarbons obtained from the catalytic
reforming of straight-run naphtha. It consists of hydrogen and hydrocar-
bons having carbon numbers predominantly in the range of C1 through
C6.)

Tail gas (petroleum), catalytic reformed naphtha stabiliser; Refinery gas

649-142-00-0

270-808-8

68478-28-4

K

(A complex combination of hydrocarbons obtained from the stabilisation
of catalytic reformed naphtha. It consists of hydrogen and hydrocarbons
having carbon numbers predominantly in the range of C1 through C6.)

Tail gas (petroleum), cracked distillate hydrotreater separator; Refinery gas

649-143-00-6

270-809-3

68478-29-5

K

(A complex combination of hydrocarbons obtained by treating cracked
distillates with hydrogen in the presence of a catalyst.
It consists of
hydrogen and saturated aliphatic hydrocarbons having carbon numbers
predominantly in the range of C1 through C5.)

Tail gas (petroleum), hydrodesulphurised straight-run naphtha separator;
Refinery gas

(A complex combination of hydrocarbons obtained from hydrodesulphur-
isation of straight-run naphtha. It consists of hydrogen and saturated
aliphatic hydrocarbons having carbon numbers predominantly in the
range of C1 through C6.)

Gases (petroleum), catalytic reformed straight-run naphtha stabiliser over-
heads; Refinery gas

(A complex combination of hydrocarbons obtained from the catalytic
reforming of straight-run naphtha followed by fractionation of the total
effluent. It consists of hydrogen, methane, ethane and propane.)

649-144-00-1

270-810-9

68478-30-8

K

649-145-00-7

270-999-8

68513-14-4

K

(petroleum),

Gases
Refinery gas

reformer effluent high-pressure flash drum off;

649-146-00-2

271-003-4

68513-18-8

K

(A complex combination produced by the high-pressure flashing of the
effluent from the reforming reactor. It consists primarily of hydrogen
with various small amounts of methane, ethane, and propane.)

Gases (petroleum), reformer effluent low-pressure flash drum off; Refinery
gas

(A complex combination produced by low-pressure flashing of
the
effluent from the reforming reactor. It consists primarily of hydrogen
with various small amounts of methane, ethane, and propane.)

649-147-00-8

271-005-5

68513-19-9

K

14.11.2006

EN

Official Journal of the European Union

C 276E/183

Substances

Index number

EC number

CAS number

Notes

Gases (petroleum), oil refinery gas distn. off; Refinery gas

649-148-00-3

271-258-1

68527-15-1

K

(A complex combination separated by distillation of a gas stream
containing hydrogen, carbon monoxide, carbon dioxide and hydrocar-
bons having carbon numbers in the range of C1 through C6 or obtained
by cracking ethane and propane.
It consists of hydrocarbons having
carbon numbers predominantly in the range of C1 through C2, hydrogen,
nitrogen, and carbon monoxide.)

Gases (petroleum), benzene unit hydrotreater depentaniser overheads;
Refinery gas

(A complex combination produced by treating the feed from the benzene
unit with hydrogen in the presence of a catalyst followed by depenta-
It consists primarily of hydrogen, ethane and propane with
nising.
various small amounts of nitrogen, carbon monoxide, carbon dioxide and
hydrocarbons having carbon numbers predominantly in the range of C1
through C6. It may contain trace amounts of benzene.)

649-149-00-9

271-623-5

68602-82-4

K

Gases (petroleum), secondary absorber off, fluidised catalytic cracker over-
heads fractionator; Refinery gas

(A complex combination produced by the fractionation of the overhead
products from the catalytic cracking process in the fluidised catalytic
cracker.
It consists of hydrogen, nitrogen, and hydrocarbons having
carbon numbers predominantly in the range of C1 through C3.)

649-150-00-4

271-625-6

68602-84-6

K

Petroleum products, refinery gases; Refinery gas

649-151-00-X

271-750-6

68607-11-4

K

(A complex combination which consists primarily of hydrogen with
various small amounts of methane, ethane and propane.)

Gases (petroleum), hydrocracking low-pressure separator; Refinery gas

649-152-00-5

272-182-1

68783-06-2

K

(A complex combination obtained by the liquid-vapour separation of the
It consists predominantly of
hydrocracking process reactor effluent.
hydrogen and saturated hydrocarbons having carbon numbers predomi-
nantly in the range of C1 through C3.)

Gases (petroleum), refinery; Refinery gas

649-153-00-0

272-338-9

68814-67-5

K

(A complex combination obtained from various petroleum refining opera-
tions. It consists of hydrogen and hydrocarbons having carbon numbers
predominantly in the range of C1 through C3.)

Gases (petroleum), platformer products separator off; Refinery gas

649-154-00-6

272-343-6

68814-90-4

K

(A complex combination obtained from the chemical
reforming of
naphthenes to aromatics. It consists of hydrogen and saturated aliphatic
hydrocarbons having carbon numbers predominantly in the range of C2
through C4.)

C 276E/184

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Gases (petroleum), hydrotreated sour kerosine depentaniser stabiliser off;
Refinery gas

(The complex combination obtained from the depentaniser stabilisation
of hydrotreated kerosine.
It consists primarily of hydrogen, methane,
ethane, and propane with various small amounts of nitrogen, hydrogen
sulphide, carbon monoxide and hydrocarbons having carbon numbers
predominantly in the range of C4 through C5.)

649-155-00-1

272-775-5

68911-58-0

K

Gases (petroleum), hydrotreated sour kerosine flash drum; Refinery gas

649-156-00-7

272-776-0

68911-59-1

K

(A complex combination obtained from the flash drum of
the unit
treating sour kerosine with hydrogen in the presence of a catalyst. It
consists primarily of hydrogen and methane with various small amounts
of nitrogen, carbon monoxide, and hydro-carbons having carbon
numbers predominantly in the range of C2 through C5.)

(petroleum), distillate unifiner desulphurisation stripper off;

Gases
Refinery gas

(A complex combination stripped from the liquid product of the unifiner
desulphurisation process.
It consists of hydrogen sulphide, methane,
ethane, and propane.)

Gases (petroleum), fluidised catalytic cracker fractionation off; Refinery
gas

(A complex combination produced by the fractionation of the overhead
product of the fluidised catalytic cracking process. It consists of hydrogen,
hydrogen sulphide, nitrogen, and hydrocarbons having carbon numbers
predominantly in the range of C1 through C5.)

649-157-00-2

272-873-8

68919-01-7

K

649-158-00-8

272-874-3

68919-02-8

K

Gases
(petroleum),
absorber off; Refinery gas

fluidised catalytic

cracker

scrubbing secondary

649-159-00-3

272-875-9

68919-03-9

K

(A complex combination produced by scrubbing the overhead gas from
the fluidised catalytic cracker. It consists of hydrogen, nitrogen, methane,
ethane and propane.)

Gases (petroleum), heavy distillate hydrotreater desulphurisation stripper
off; Refinery gas

(A complex combination stripped from the liquid product of the heavy
distillate hydrotreater desulphurisation process. It consists of hydrogen,
hydrogen sulphide, and saturated aliphatic hydrocarbons having carbon
numbers predominantly in the range of C1 through C5.)

649-160-00-9

272-876-4

68919-04-0

K

Gases (petroleum), platformer stabiliser off,
Refinery gas

light ends fractionation;

649-161-00-4

272-880-6

68919-07-3

K

(A complex combination obtained by the fractionation of the light ends
of the platinum reactors of the platformer unit. It consists of hydrogen,
methane, ethane and propane.)

Gases (petroleum), preflash tower off, crude distn.; Refinery gas

649-162-00-X

272-881-1

68919-08-4

K

(A complex combination produced from the first tower used in the distil-
lation of crude oil. It consists of nitrogen and saturated aliphatic hydro-
carbons having carbon numbers predominantly in the range of C1
through C5.)

14.11.2006

EN

Official Journal of the European Union

C 276E/185

Substances

Index number

EC number

CAS number

Notes

Gases (petroleum), tar stripper off; Refinery gas

649-163-00-5

272-884-8

68919-11-9

K

(A complex combination obtained by the fractionation of reduced crude
oil. It consists of hydrogen and hydrocarbons having carbon numbers
predominantly in the range of C1 through C4.)

Gases (petroleum), unifiner stripper off; Refinery gas

649-164-00-0

272-885-3

68919-12-0

K

(A combination of hydrogen and methane obtained by fractionation of
the products from the unifiner unit.)

Tail gas (petroleum), catalytic hydrodesulphurised naphtha separator;
Refinery gas

(A complex combination of hydrocarbons obtained from the hydrodesul-
phurisation of naphtha. It consists of hydrogen, methane, ethane, and
propane.)

649-165-00-6

273-173-5

68952-79-4

K

Tail gas (petroleum), straight-run naphtha hydrodesulphuriser; Refinery
gas

(A complex combination obtained from the hydrodesulphurisation of
straight-run naphtha. It consists of hydrogen and hydrocarbons having
carbon numbers predominantly in the range of C1 through C5.)

649-166-00-1

273-174-0

68952-80-7

K

Gases (petroleum), sponge absorber off, fluidised catalytic cracker and gas
oil desulphuriser overhead fractionation; Refinery gas

(A complex combination obtained by the fractionation of products from
the fluidised catalytic cracker and gas oil desulphuriser. It consists of
hydrogen and hydrocarbons having carbon numbers predominantly in
the range of C1 through C4.)

649-167-00-7

273-269-7

68955-33-9

K

Gases (petroleum), crude distn. and catalytic cracking; Refinery gas

649-168-00-2

273-563-5

68989-88-8

K

(A complex combination produced by crude distillation and catalytic
cracking processes. It consists of hydrogen, hydrogen sulphide, nitrogen,
carbon monoxide and paraffinic and olefinic hydrocarbons having carbon
numbers predominantly in the range of C1 through C6.)

Gases (petroleum), gas oil diethanolamine scrubber off; Refinery gas

649-169-00-8

295-397-2

92045-15-3

K

(A complex combination produced by desulphurisation of gas oils with
consists predominantly of hydrogen sulphide,
diethanolamine.
hydrogen and aliphatic hydrocarbons having carbon numbers in the
range of C1 through C5.)

It

Gases (petroleum), gas oil hydrodesulphurisation effluent; Refinery gas

649-170-00-3

295-398-8

92045-16-4

K

(A complex combination obtained by separation of the liquid phase from
the effluent from the hydrogenation reaction. It consists predominantly of
hydrogen, hydrogen sulphide and aliphatic hydrocarbons having carbon
numbers predominantly in the range of C1 through C3.)

C 276E/186

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Gases (petroleum), gas oil hydrodesulphurisation purge; Refinery gas

649-171-00-9

295-399-3

92045-17-5

K

(A complex combination of gases obtained from the reformer and from
the purges from the hydrogenation reactor. It consists predominantly of
hydrogen and aliphatic hydrocarbons having carbon numbers predomi-
nantly in the range of C1 through C4.)

Gases (petroleum), hydrogenator effluent flash drum off; Refinery gas

649-172-00-4

295-400-7

92045-18-6

K

(A complex combination of gases obtained from flash of the effluents
after the hydrogenation reaction. It consists predominantly of hydrogen
and aliphatic hydrocarbons having carbon numbers predominantly in the
range of C1 through C6.)

(petroleum), naphtha steam cracking high-pressure

Gases
Refinery gas

residual;

649-173-00-X

295-401-2

92045-19-7

K

(A complex combination obtained as a mixture of the non-condensable
portions from the product of a naphtha steam cracking process as well as
residual gases obtained during the preparation of subsequent products. It
consists predominantly of hydrogen and paraffinic and olefinic hydrocar-
bons having carbon numbers predominantly in the range of C1 through
C5 with which natural gas may also be mixed.)

Gases (petroleum), residue visbaking off; Refinery gas

649-174-00-5

295-402-8

92045-20-0

K

(A complex combination obtained from viscosity reduction of residues in
a furnace. It consists predominantly of hydrogen sulphide and paraffinic
and olefinic hydrocarbons having carbon numbers predominantly in the
range of C1 through C5.)

Foots oil (petroleum), acid-treated; Foots oil

649-175-00-0

300-225-7

93924-31-3

L

(A complex combination of hydrocarbons obtained by treatment of Foot's
oil with sulphuric acid.
It consists predominantly of branched-chain
hydrocarbons with carbon numbers predominantly in the range of C20
through C50.)

Foots oil (petroleum), clay-treated; Foots oil

649-176-00-6

300-226-2

93924-32-4

L

(A complex combination of hydrocarbons obtained by treatment of Foot's
oil with natural or modified clay in either a contacting or percolation
process to remove the trace amounts of polar compounds and impurities
present. It consists predominantly of branched chain hydrocarbons with
carbon numbers predominantly in the range of C20 through C50.)

Gases (petroleum), C3-4; Petroleum gas
(A complex combination of hydrocarbons produced by distillation of
products from the cracking of crude oil.
It consists of hydrocarbons
having carbon numbers in the range of C3 through C4, predominantly of
propane and propylene, and boiling in the range of approximately -51 °C
to -1 °C.)

649-177-00-1

268-629-5

68131-75-9

K

14.11.2006

EN

Official Journal of the European Union

C 276E/187

Substances

Index number

EC number

CAS number

Notes

Tail gas (petroleum), catalytic cracked distillate and catalytic cracked
naphtha fractionation absorber; Petroleum gas

(The complex combination of hydrocarbons from the distillation of the
products from catalytic cracked distillates and catalytic cracked naphtha.
It consists predominantly of hydrocarbons having carbon numbers in the
range of C1 through C4.)

649-178-00-7

269-617-2

68307-98-2

K

Tail gas (petroleum), catalytic polymn. naphtha fractionation stabiliser;
Petroleum gas

(A complex combination of hydrocarbons from the fractionation stabilisa-
tion products from polymerisation of naphtha. It consists predominantly
of hydrocarbons having carbon numbers in the range of C1 through C4.)

649-179-00-2

269-618-8

68307-99-3

K

Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser,
hydrogen sulphide-free; Petroleum gas

(A complex combination of hydrocarbons obtained from fractionation
stabilisation of catalytic reformed naphtha and from which hydrogen
sulphide has been removed by amine treatment. It consists predominantly
of hydrocarbons having carbon numbers predominantly in the range of
C1 through C4.)

Tail gas (petroleum), cracked distillate hydrotreater stripper; Petroleum
gas

(A complex combination of hydrocarbons obtained by treating thermal
cracked distillates with hydrogen in the presence of a catalyst. It consists
predominantly of saturated hydrocarbons having carbon numbers predo-
minantly in the range of C1 through C6.)

Tail gas (petroleum), straight-run distillate hydrodesulphuriser, hydrogen
sulphide-free; Petroleum gas

(A complex combination of hydrocarbons obtained from catalytic hydro-
desulphurisation of straight run distillates and from which hydrogen
sulphide has been removed by amine treatment. It consists predominantly
of hydrocarbons having carbon numbers predominantly in the range of
C1 through C4.)

649-180-00-8

269-619-3

68308-00-9

K

649-181-00-3

269-620-9

68308-01-0

K

649-182-00-9

269-630-3

68308-10-1

K

Tail gas (petroleum), gas oil catalytic cracking absorber; Petroleum gas

649-183-00-4

269-623-5

68308-03-2

K

(A complex combination of hydrocarbons obtained from the distillation
of products from the catalytic cracking of gas oil. It consists predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of C1 through C5.)

Tail gas (petroleum), gas recovery plant; Petroleum gas

649-184-00-X

269-624-0

68308-04-3

K

(A complex combination of hydrocarbons
from the distillation of
products from miscellaneous hydrocarbon streams. It consists predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of C1 through C5.)

C 276E/188

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Tail gas (petroleum), gas recovery plant deethaniser; Petroleum gas

649-185-00-5

269-625-6

68308-05-4

K

(A complex combination of hydrocarbons
from the distillation of
products from miscellaneous hydrocarbon streams. It consists of hydro-
carbon having carbon numbers predominantly in the range of C1 through
C4.)

Tail gas (petroleum), hydrodesulphurised distillate and hydrodesulphurised
naphtha fractionator, acid-free; Petroleum gas

(A complex combination of hydrocarbons obtained from fractionation of
hydrodesulphurised naphtha and distillate hydrocarbon streams and
treated to remove acidic impurities. It consists predominantly of hydro-
carbons having carbon numbers predominantly in the range of C1
through C5.)

649-186-00-0

269-626-1

68308-06-5

K

Tail gas
hydrogen sulphide-free; Petroleum gas

(petroleum), hydrodesulphurised vacuum gas oil

stripper,

649-187-00-6

269-627-7

68308-07-6

K

(A complex combination of hydrocarbons obtained from stripping stabili-
sation of catalytic hydrodesulphurised vacuum gas oil and from which
hydrogen sulphide has been removed by amine treatment. It consists
predominantly of hydrocarbons having carbon numbers predominantly in
the range of C1 through C6.)

Tail gas (petroleum),
sulphide-free; Petroleum gas

light straight-run naphtha stabiliser, hydrogen

(A complex combination of hydrocarbons obtained from fractionation
light straight-run naphtha and from which hydrogen
stabilisation of
sulphide has been removed by amine treatment. It consists predominantly
of hydrocarbons having carbon numbers predominantly in the range of
C1 through C5.)

Tail gas (petroleum), propane-propylene alkylation feed prep deethaniser;
Petroleum gas

(A complex combination of hydrocarbons obtained from the distillation
of the reaction products of propane with propylene. It consists of hydro-
carbons having carbon numbers predominantly in the range of C1
through C4.)

Tail gas
sulphide-free; Petroleum gas

(petroleum), vacuum gas oil hydrodesulphuriser, hydrogen

(A complex combination of hydrocarbons obtained from catalytic hydro-
desulphurisation of vacuum gas oil and from which hydrogen sulphide
has been removed by amine treatment.
It consists predominantly of
hydrocarbons having carbon numbers predominantly in the range of C1
through C6.)

649-188-00-1

269-629-8

68308-09-8

K

649-189-00-7

269-631-9

68308-11-2

K

649-190-00-2

269-632-4

68308-12-3

K

Gases (petroleum), catalytic cracked overheads; Petroleum gas

649-191-00-8

270-071-2

68409-99-4

K

(A complex combination of hydrocarbons produced by the distillation of
products from the catalytic cracking process. It consists of hydrocarbons
having carbon numbers predominantly in the range of C3 through C5 and
boiling in the range of approximately -48 °C to 32 °C.)

Alkanes, C1-2; Petroleum gas

649-193-00-9

270-651-5

68475-57-0

Alkanes, C2-3; Petroleum gas

649-194-00-4

270-652-0

68475-58-1

K

K

14.11.2006

EN

Official Journal of the European Union

C 276E/189

Substances

Index number

EC number

CAS number

Notes

Alkanes, C3-4; Petroleum gas

649-195-00-X

270-653-6

68475-59-2

Alkanes, C4-5; Petroleum gas

649-196-00-5

270-654-1

68475-60-5

Fuel gases; Petroleum gas

649-197-00-0

270-667-2

68476-26-6

(A combination of light gases. It consists predominantly of hydrogen and/
or low molecular weight hydrocarbons.)

K

K

K

Fuel gases, crude oil of distillates; Petroleum gas

649-198-00-6

270-670-9

68476-29-9

K

(A complex combination of light gases produced by distillation of crude
oil and by catalytic reforming of naphtha. It consists of hydrogen and
hydrocarbons having carbon numbers predominantly in the range of C1
through C4 and boiling in the range of approximately -217 °C to -12 °C.)

Hydrocarbons, C3-4; Petroleum gas

649-199-00-1

270-681-9

68476-40-4

Hydrocarbons, C4-5; Petroleum gas

649-200-00-5

270-682-4

68476-42-6

Hydrocarbons, C2-4, C3-rich; Petroleum gas

649-201-00-0

270-689-2

68476-49-3

Petroleum gases, liquefied; Petroleum gas

649-202-00-6

270-704-2

68476-85-7

(A complex combination of hydrocarbons produced by the distillation of
crude oil. It consists of hydrocarbons having carbon numbers predomi-
nantly in the range of C3 through C7 and boiling in the range of approxi-
mately -40 °C to 80 °C.)

K

K

K

K

Petroleum gases, liquefied, sweetened; Petroleum gas

649-203-00-1

270-705-8

68476-86-8

K

(A complex combination of hydrocarbons obtained by subjecting lique-
fied petroleum gas mix to a sweetening process to convert mercaptans or
to remove acidic impurities. It consists of hydrocarbons having carbon
numbers predominantly in the range of C3 through C7 and boiling in the
range of approximately -40 °C to 80 °C.)

Gases (petroleum), C3-4, isobutane-rich; Petroleum gas
(A complex combination of hydrocarbons from the distillation of satu-
rated and unsaturated hydrocarbons usually ranging in carbon numbers
from C3 through C6, predominantly butane and isobutane. It consists of
saturated and unsaturated hydrocarbons having carbon numbers in the
range of C3 through C4, predominantly isobutane.)

Distillates (petroleum), C3-6, piperylene-rich; Petroleum gas
(A complex combination of hydrocarbons from the distillation of satu-
rated and unsaturated aliphatic hydrocarbons usually ranging in the
carbon numbers C3 through C6. It consists of saturated and unsaturated
hydrocarbons having carbon numbers in the range of C3 through C6,
predominantly piperylenes.)

649-204-00-7

270-724-1

68477-33-8

K

649-205-00-2

270-726-2

68477-35-0

K

C 276E/190

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Gases (petroleum), butane splitter overheads; Petroleum gas

649-206-00-8

270-750-3

68477-69-0

K

(A complex combination of hydrocarbons obtained from the distillation
of the butane stream. It consists of aliphatic hydrocarbons having carbon
numbers predominantly in the range of C3 through C4.)

Gases (petroleum), C2-3; Petroleum gas
(A complex combination of hydrocarbons produced by the distillation of
products from a catalytic fractionation process. It contains predominantly
ethane, ethylene, propane, and propylene.)

649-207-00-3

270-751-9

68477-70-3

K

Gases (petroleum), catalytic-cracked gas oil depropaniser bottoms, C4-rich
acid-free; Petroleum gas

(A complex combination of hydrocarbons obtained from fractionation of
catalytic cracked gas oil hydrocarbon stream and treated to remove
hydrogen sulphide and other acidic components. It consists of hydrocar-
bons having carbon numbers in the range of C3 through C5, predomi-
nantly C4.)

649-208-00-9

270-752-4

68477-71-4

K

Gases (petroleum), catalytic-cracked naphtha debutaniser bottoms, C3-5-
rich; Petroleum gas

(A complex combination of hydrocarbons obtained from the stabilisation
of catalytic cracked naphtha. It consists of aliphatic hydrocarbons having
carbon numbers predominantly in the range of C3 through C5.)

649-209-00-4

270-754-5

68477-72-5

K

Tail gas (petroleum),
leum gas

isomerised naphtha fractionation stabiliser; Petro-

649-210-00-X

269-628-2

68308-08-7

K

(A complex combination of hydrocarbons obtained from the fractionation
stabilisation products from isomerised naphtha. It consists predominantly
of hydrocarbons having carbon numbers predominantly in the range of
C1 through C4.)

Foots oil (petroleum), carbon-treated; Foot's oil

649-211-00-5

308-126-0

97862-76-5

L

(A complex combination of hydrocarbons obtained by the treatment of
Foot's oil with activated carbon for the removal of trace constituents and
impurities. It consists predominantly of saturated straight chain hydrocar-
bons having carbon numbers predominantly greater than C12.)

Distillates (petroleum), sweetened middle; Gas oil — unspecified

649-212-00-0

265-088-7

64741-86-2

N

(A complex combination of hydrocarbons obtained by subjecting a petro-
leum distillate to a sweetening process to convert mercaptans or to
remove acidic impurities.
It consists of hydrocarbons having carbon
numbers predominantly in the range of C9 through C20 and boiling in the
range of approximately 150 °C to 345 °C.)

14.11.2006

EN

Official Journal of the European Union

C 276E/191

Substances

Index number

EC number

CAS number

Notes

Gas oils (petroleum), solvent-refined; Gas oil — unspecified

649-213-00-6

265-092-9

64741-90-8

N

(A complex combination of hydrocarbons obtained as the raffinate from
a solvent extraction process. It consists predominantly of aliphatic hydro-
carbons having carbon numbers predominantly in the range of C11
through C25 and boiling in the range of approximately 205 °C to 400 °C.)

Distillates (petroleum), solvent-refined middle; Gas oil — unspecified

649-214-00-1

265-093-4

64741-91-9

N

(A complex combination of hydrocarbons obtained as the raffinate from
a solvent extraction process. It consists predominantly of aliphatic hydro-
carbons having carbon numbers predominantly in the range of C9
through C20 and boiling in the range of approximately 150 °C to 345 °C.)

Gas oils (petroleum), acid-treated; Gas oil — unspecified

649-215-00-7

265-112-6

64742-12-7

N

(A complex combination of hydrocarbons obtained as a raffinate from a
sulphuric acid treating process. It consists of hydrocarbons having carbon
numbers predominantly in the range of C13 through C25 and boiling in
the range of approximately 230 °C to 400 °C.)

Distillates (petroleum), acid-treated middle; Gas oil — unspecified

649-216-00-2

265-113-1

64742-13-8

N

(A complex combination of hydrocarbons obtained as a raffinate from a
sulphuric acid treating process. It consists of hydrocarbons having carbon
numbers predominantly in the range of C11 through C20 and boiling in
the range of approximately 205 °C to 345 °C.)

Distillates (petroleum), acid-treated light; Gas oil — unspecified

649-217-00-8

265-114-7

64742-14-9

N

(A complex combination of hydrocarbons obtained as a raffinate from a
sulphuric acid treating process. It consists of hydrocarbons having carbon
numbers predominantly in the range of C9 through C16 and boiling in the
range of approximately 150 °C to 290 °C.)

Gas oils (petroleum), chemically neutralised; Gas oil — unspecified

649-218-00-3

265-129-9

64742-29-6

N

(A complex combination of hydrocarbons produced by a treating process
to remove acidic materials. It consists of hydrocarbons having carbon
numbers predominantly in the range of C13 through C25 and boiling in
the range of approximately 230 °C to 400 °C.)

Distillates (petroleum), chemically neutralised middle; Gas oil — unspeci-
fied

(A complex combination of hydrocarbons produced by a treating process
to remove acidic materials. It consists of hydrocarbons having carbon
numbers predominantly in the range of C11 through C20 and boiling in
the range of approximately 205 °C to 345 °C.)

649-219-00-9

265-130-4

64742-30-9

N

C 276E/192

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Distillates (petroleum), clay-treated middle; Gas oil — unspecified

649-220-00-4

265-139-3

64742-38-7

N

(A complex combination of hydrocarbons resulting from treatment of a
petroleum fraction with natural or modified clay, usually in a percolation
process to remove the trace amounts of polar compounds and impurities
present. It consists of hydrocarbons having carbon numbers predomi-
nantly in the range of C9 through C20 and boiling in the range of approxi-
mately 150 °C to 345 °C.)

Distillates (petroleum), hydrotreated middle; Gas oil — unspecified

649-221-00-X

265-148-2

64742-46-7

N

(A complex combination of hydrocarbons obtained by treating a petro-
leum fraction with hydrogen in the presence of a catalyst. It consists of
hydrocarbons having carbon numbers predominantly in the range of C11
through C25 and boiling in the range of approximately 205 °C to 400 °C.)

Gas oils (petroleum), hydrodesuphurised; Gas oil — unspecified

649-222-00-5

265-182-8

64742-79-6

N

(A complex combination of hydrocarbons obtained from a petroleum
stock by treating with hydrogen to convert organic sulphur to hydrogen
sulphide which is removed. It consists predominantly of hydrocarbons
having carbon numbers predominantly in the range of C13 through C25
and boiling in the range of approximately 230 °C to 400 °C.)

Distillates (petroleum), hydrodesulphurised middle; Gas oil — unspecified

649-223-00-0

265-183-3

64742-80-9

N

(A complex combination of hydrocarbons obtained from a petroleum
stock by treating with hydrogen to convert organic sulphur to hydrogen
sulphide which is removed. It consists of hydrocarbons having carbon
numbers predominantly in the range of C11 through C25 and boiling in
the range of approximately 205 °C to 400 °C.)

Distillates
boiling; Gas oil — unspecified

(petroleum), catalytic reformer

fractionator

residue, high-

649-228-00-8

270-719-4

68477-29-2

N

(A complex combination of hydrocarbons from the distillation of catalytic
reformer fractionator residue.
It boils in the range of approximately
343 °C to 399 °C.)

Distillates
mediate-boiling; Gas oil — unspecified

(petroleum), catalytic reformer

fractionator

residue,

inter-

649-229-00-3

270-721-5

68477-30-5

N

(A complex combination of hydrocarbons from the distillation of catalytic
reformer fractionator residue.
It boils in the range of approximately
288 °C to 371 °C.)

Distillates (petroleum), catalytic reformer fractionator residue, low-boiling;
Gas oil — unspecified

(The complex combination of hydrocarbons from the distillation of cata-
lytic reformer fractionator residue. It boils approximately below 288 °C.)

649-230-00-9

270-722-0

68477-31-6

N

14.11.2006

EN

Official Journal of the European Union

C 276E/193

Substances

Index number

EC number

CAS number

Notes

Distillates (petroleum), highly refined middle; Gas oil — unspecified

649-231-00-4

292-615-8

90640-93-0

N

(A complex combination of hydrocarbons obtained by the subjection of a
petroleum fraction to several of the following steps: filtration, centrifuga-
tion, atmospheric distillation, vacuum distillation, acidification, neutralisa-
tion and clay treatment.
It consists predominantly of hydrocarbons
having carbon numbers predominantly in the range of C10 through C20.)

Distillates (petroleum) catalytic reformer, heavy arom. conc.; Gas oil —
unspecified

(A complex combination of hydrocarbons obtained from the distillation
of a catalytically reformed petroleum cut. It consists predominantly of
aromatic hydrocarbons having carbon numbers predominantly in the
range of C10 through C16 and boiling in the range of approximately
200 °C to 300 °C.)

649-232-00-X

295-294-2

91995-34-5

N

Gas oils, paraffinic; Gas oil — unspecified

649-233-00-5

300-227-8

93924-33-5

N

(A distillate obtained from the redistillation of a complex combination of
hydrocarbons obtained by the distillation of the effluents from a severe
catalytic hydrotreatment of paraffins. It boils in the range of approxi-
mately 190 °C to 330 °C.)

Naphtha (petroleum), solvent-refined hydrodesulphurised heavy; Gas oil
— unspecified

649-234-00-0

307-035-3

97488-96-5

N

Hydrocarbons, C16-20, hydrotreated middle distillate, distn. lights; Gas oil
— unspecified

(A complex combination of hydrocarbons obtained as first runnings from
the vacuum distillation of effluents from the treatment of a middle distil-
late with hydrogen. It consists predominantly of hydrocarbons having
carbon numbers predominantly in the range of C16 through C20 and
boiling in the range of approximately 290 °C to 350 °C. It produces a
finished oil having a viscosity of 2 10-6 m2·s-1 at 100 °C.)

649-235-00-6

307-659-6

97675-85-9

N

Hydrocarbons, C12-20, hydrotreated paraffinic, distn.
unspecified

lights; Gas oil —

649-236-00-1

307-660-1

97675-86-0

N

(A complex combination of hydrocarbons obtained as first runnings from
the vacuum distillation of effluents from the treatment of heavy paraffins
with hydrogen in the presence of a catalyst. It consists predominantly of
hydrocarbons having carbon numbers predominantly in the range of C12
through C20 and boiling in the range of approximately 230 °C to 350 °C.
It produces a finished oil having a viscosity of 2 10-6 m2·s-1 at 100 °C.)

Hydrocarbons, C11-17, solvent-extd. light naphthenic; Gas oil — unspeci-
fied

(A complex combination of hydrocarbons obtained by extraction of the
aromatics from a light naphthenic distillate having a viscosity of 2.2 10-
6 m2·s-1 at 40 °C.
It consists predominantly of hydrocarbons having
carbon numbers predominantly in the range of C11 through C17 and
boiling in the range of approximately 200 °C to 300 °C.)

649-237-00-7

307-757-9

97722-08-2

N

C 276E/194

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Gas oils, hydrotreated; Gas oil — unspecified

649-238-00-2

308-128-1

97862-78-7

N

(A complex combination of hydrocarbons obtained from the redistillation
of the effluents from the treatment of paraffins with hydrogen in the
presence of a catalyst. It consists predominantly of hydrocarbons having
carbon numbers predominantly in the range of C17 through C27 and
boiling in the range of approximately 330 °C to 340 °C.)

Distillates (petroleum), carbon-treated light paraffinic; Gas oil — unspeci-
fied

(A complex combination of hydrocarbons obtained by the treatment of a
petroleum oil fraction with activated charcoal for the removal of traces of
polar constituents and impurities. It consists predominantly of hydrocar-
bons having carbon numbers predominantly in the range of C12 through
C28.)

Distillates (petroleum), intermediate paraffinic, carbon-treated; Gas oil —
unspecified

(A complex combination of hydrocarbons obtained by the treatment of
petroleum with activated charcoal for the removal of trace polar constitu-
ents and impurities. It consists predominantly of hydrocarbons having
carbon numbers predominantly in the range of C16 through C36.)

649-239-00-8

309-667-5

100683-97-4

N

649-240-00-3

309-668-0

100683-98-5

N

Distillates (petroleum),
unspecified

intermediate paraffinic, clay-treated; Gas oil —

649-241-00-9

309-669-6

100683-99-6

N

(A complex combination of hydrocarbons obtained by the treatment of
petroleum with bleaching earth for the removal of trace polar constitu-
ents and impurities. It consists predominantly of hydrocarbons having
carbon numbers predominantly in the range of C16 through C36.)

Alkanes, C12-26-branched and linear;

649-242-00-4

292-454-3

90622-53-0

Lubricating greases; Grease

649-243-00-X

278-011-7

74869-21-9

(A complex combination of hydrocarbons having carbon numbers predo-
minantly in the range of C12 through C50. May contain organic salts of
alkali metals, alkaline earth metals, and/or aluminium compounds.)

N

N

Slack wax (petroleum); Slack wax

649-244-00-5

265-165-5

64742-61-6

N

(A complex combination of hydrocarbons obtained from a petroleum
fraction by solvent crystallisation (solvent dewaxing) or as a distillation
fraction from a very waxy crude. It consists predominantly of saturated
straight and branched chain hydrocarbons having carbon numbers predo-
minantly greater than C20.)

Slack wax (petroleum), acid-treated; Slack wax

649-245-00-0

292-659-8

90669-77-5

N

(A complex combination of hydrocarbons obtained as a raffinate by treat-
ment of a petroleum slack wax fraction with sulphuric acid treating
process.
It consists predominantly of saturated straight and branched
chain hydrocarbons having carbon numbers predominantly greater than
C20.)

14.11.2006

EN

Official Journal of the European Union

C 276E/195

Substances

Index number

EC number

CAS number

Notes

Slack wax (petroleum), clay-treated; Slack wax

649-246-00-6

292-660-3

90669-78-6

N

(A complex combination of hydrocarbons obtained by treatment of a
petroleum slack wax fraction with natural or modified clay in either a
contacting or percolation process. It consists predominantly of saturated
straight and branched hydrocarbons having carbon numbers predomi-
nantly greater than C20.)

Slack wax (petroleum), hydrotreated; Slack wax

649-247-00-1

295-523-6

92062-09-4

N

(A complex combination of hydrocarbons obtained by treating slack wax
with hydrogen in the presence of a catalyst. It consists predominantly of
saturated straight and branched chain hydrocarbons having carbon
numbers predominantly greater than C20.)

Slack wax (petroleum), low-melting; Slack wax

649-248-00-7

295-524-1

92062-10-7

N

(A complex combination of hydrocarbons obtained from a petroleum
fraction by solvent deparaffination. It consists predominantly of saturated
straight and branched chain hydrocarbons having carbon numbers predo-
minantly greater than C12.)

Slack wax (petroleum), low-melting, hydrotreated; Slack wax

649-249-00-2

295-525-7

92062-11-8

N

(A complex combination of hydrocarbons obtained by treatment of low-
melting petroleum slack wax with hydrogen in the presence of a catalyst.
It consists predominantly of saturated straight and branched chain hydro-
carbons having carbon numbers predominantly greater than C12.)

Slack wax (petroleum), low-melting, carbon-treated; Slack wax

649-250-00-8

308-155-9

97863-04-2

N

(A complex combination of hydrocarbons obtained by the treatment of
low-melting slack wax with activated carbon for the removal of trace
polar constituents and impurities. It consists predominantly of saturated
straight and branched chain hydrocarbons having carbon numbers predo-
minantly greater than C12.)

Slack wax (petroleum), low-melting, clay-treated; Slack wax

649-251-00-3

308-156-4

97863-05-3

N

(A complex combination of hydrocarbons obtained by the treatment of
low-melting petroleum slack wax with bentonite for removal of trace
polar constituents and impurities. It consists predominantly of saturated
straight and branched chain hydrocarbons having carbon numbers predo-
minantly greater than C12.)

Slack wax (petroleum), low-melting, silicic acid-treated; Slack wax

649-252-00-9

308-158-5

97863-06-4

N

(A complex combination of hydrocarbons obtained by the treatment of
low-melting petroleum slack wax with silicic acid for the removal of trace
polar constituents and impurities. It consists predominantly of saturated
straight and branched chain hydrocarbons having carbon numbers predo-
minantly greater than C12.)

C 276E/196

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Slack wax (petroleum), carbon-treated; Slack wax

649-253-00-4

309-723-9

100684-49-9

N

(A complex combination of hydrocarbons obtained by treatment of petro-
leum slack wax with activated charcoal for the removal of trace polar
constituents and impurities.)

Petrolatum; Petrolatum

649-254-00-X

232-373-2

8009-03-8

N

(A complex combination of hydrocarbons obtained as a semi-solid from
dewaxing paraffinic residual oil. It consists predominantly of saturated
crystalline and liquid hydrocarbons having carbon numbers predomi-
nantly greater than C25.)

Petrolatum (petroleum), oxidised; Petrolatum

649-255-00-5

265-206-7

64743-01-7

N

(A complex combination of organic compounds, predominantly high
molecular weight carboxylic acids, obtained by the air oxidation of petro-
latum.)

Petrolatum (petroleum), alumina-treated; Petrolatum

649-256-00-0

285-098-5

85029-74-9

N

(A complex combination of hydrocarbons obtained when petrolatum is
treated with Al2O>
It
consists predominantly of saturated, crystalline, and liquid hydrocarbons
having carbon numbers predominantly greater than C25.)

to remove polar components and impurities.

Petrolatum (petroleum), hydrotreated; Petrolatum

649-257-00-6

295-459-9

92045-77-7

N

(A complex combination of hydrocarbons obtained as a semi-solid from
dewaxed paraffinic residual oil treated with hydrogen in the presence of a
catalyst.
It consists predominantly of saturated, microcrystalline, and
liquid hydrocarbons having carbon numbers predominantly greater than
C20.)

Petrolatum (petroleum), carbon-treated; Petrolatum

649-258-00-1

308-149-6

97862-97-0

N

(A complex combination of hydrocarbons obtained by the treatment of
petroleum petrolatum with activated carbon for the removal of trace
polar constituents and impurities. It consists predominantly of saturated
hydrocarbons having carbon numbers predominantly greater than C20.)

Petrolatum (petroleum), silicic acid-treated; Petrolatum

649-259-00-7

308-150-1

97862-98-1

N

(A complex combination of hydrocarbons obtained by the treatment of
petroleum petrolatum with silicic acid for the removal of trace polar
constituents and impurities. It consists predominantly of saturated hydro-
carbons having carbon numbers predominantly greater than C20.)

Petrolatum (petroleum), clay-treated; Petrolatum

649-260-00-2

309-706-6

100684-33-1

N

(A complex combination of hydrocarbons obtained by treatment of petro-
latum with bleaching earth for the removal of traces of polar constituents
and impurities. It consists predominantly of hydrocarbons having carbon
numbers predominantly in the range of greater than C25.)

14.11.2006

EN

Official Journal of the European Union

C 276E/197

Substances

Index number

EC number

CAS number

Notes

Gasoline, natural; Low boiling point naphtha

649-261-00-8

232-349-1

8006-61-9

P

(A complex combination of hydrocarbons separated from natural gas by
processes such as refrigeration or absorption. It consists predominantly of
saturated aliphatic hydrocarbons having carbon numbers predominantly
in the range of C4 through C8 and boiling in the range of approximately -
20 °C to 120 °C.)

Naphtha; Low boiling point naphtha

649-262-00-3

232-443-2

8030-30-6

P

(Refined, partly refined, or unrefined petroleum products by the distilla-
tion of natural gas. It consists of hydrocarbons having carbon numbers
predominantly in the range of C5 through C6 and boiling in the range of
approximately 100 °C to 200 °C.)

Ligroine; Low boiling point naphtha

649-263-00-9

232-453-7

8032-32-4

P

(A complex combination of hydrocarbons obtained by the fractional
distillation of petroleum. This fraction boils in a range of approximately
20 °C to 135 °C.)

Naphtha (petroleum), heavy straight-run; Low boiling point naphtha

649-264-00-4

265-041-0

64741-41-9

P

(A complex combination of hydrocarbons produced by distillation of
crude oil. It consists of hydrocarbons having carbon numbers predomi-
nantly in the range of C6 through C12 and boiling in the range of approxi-
mately 65 °C to 230 °C.)

Naphtha (petroleum), full-range straight-run; Low boiling point naphtha

649-265-00-X

265-042-6

64741-42-0

P

(A complex combination of hydrocarbons produced by distillation of
crude oil. It consists of hydrocarbons having carbon numbers predomi-
nantly in the range of C4 through C11 and boiling in the range of approxi-
mately -20 °C to 220 °C.)

Naphtha (petroleum), light straight-run; Low boiling point naphtha

649-266-00-5

265-046-8

64741-46-4

P

(A complex combination of hydrocarbons produced by distillation of
crude oil.
It consists predominantly of aliphatic hydrocarbons having
carbon numbers predominantly in the range of C4 through C10 and
boiling in the range of approximately -20 °C to 180 °C.)

Solvent naphtha (petroleum), light aliph.; Low boiling point naphtha

649-267-00-0

265-192-2

64742-89-8

P

(A complex combination of hydrocarbons obtained from the distillation
of crude oil or natural gasoline. It consists predominantly of saturated
hydrocarbons having carbon numbers predominantly in the range of C5
through C10 and boiling in the range of approximately 35 °C to 160 °C.)

Distillates (petroleum), straight-run light; Low boiling point naphtha

649-268-00-6

270-077-5

68410-05-9

P

(A complex combination of hydrocarbons produced by the distillation of
crude oil. It consists of hydrocarbons having carbon numbers predomi-
nantly in the range of C2 through C7 and boiling in the range of approxi-
mately -88 °C to 99 °C.)

C 276E/198

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Gasoline, vapour-recovery; Low boiling point naphtha

649-269-00-1

271-025-4

68514-15-8

P

(A complex combination of hydrocarbons separated from the gases from
vapour recovery systems by cooling. It consists of hydrocarbons having
carbon numbers predominantly in the range of C4 through C11 and
boiling in the range of approximately -20 °C to 196 °C.)

Gasoline, straight-run, topping-plant; Low boiling point naphtha

649-270-00-7

271-727-0

68606-11-1

P

(A complex combination of hydrocarbons produced from the topping
plant by the distillation of crude oil. It boils in the range of approximately
36,1 °C to 193,3 °C.)

Naphtha (petroleum), unsweetened; Low boiling point naphtha

649-271-00-2

272-186-3

68783-12-0

P

(A complex combination of hydrocarbons produced from the distillation
of naphtha streams from various refinery processes. It consists of hydro-
carbons having carbon numbers predominantly in the range of C5
through C12 and boiling in the range of approximately 0 °C to 230 °C.)

Distillates (petroleum), light straight-run gasoline fractionation stabiliser
overheads; Low boiling point naphtha

(A complex combination of hydrocarbons having carbon numbers predo-
minantly in the range of C3 through C6.)

649-272-00-8

272-931-2

68921-08-4

P

Naphtha (petroleum), heavy straight run, arom.-contg.; Low boiling point
naphtha

(A complex combination of hydrocarbons obtained from a distillation
process of crude petroleum. It consists predominantly of hydrocarbons
having carbon numbers in the range of C8 through C12 and boiling in the
range of approximately 130 °C to 210 °C.)

649-273-00-3

309-945-6

101631-20-3

P

Naphtha (petroleum),
naphtha

full-range alkylate; Low boiling point modified

649-274-00-9

265-066-7

64741-64-6

P

(A complex combination of hydrocarbons produced by distillation of the
reaction products of isobutane with monoolefinic hydrocarbons usually
ranging in carbon numbers from C3 through C5. It consists of predomi-
nantly branched chain saturated hydro-carbons having carbon numbers
predominantly in the range of C7 through C12 and boiling in the range of
approximately 90 °C to 220 °C.)

Naphtha (petroleum), heavy alkylate; Low boiling point modified naphtha

649-275-00-4

265-067-2

64741-65-7

P

(A complex combination of hydrocarbons produced by distillation of the
reaction products of isobutane with monoolefinic hydrocarbons usually
ranging in carbon numbers from C3 to C5. It consists of predominantly
branched chain saturated hydrocarbons having carbon numbers predomi-
nantly in the range of C9 through C12 and boiling in the range of approxi-
mately 150 °C to 220 °C.)

14.11.2006

EN

Official Journal of the European Union

C 276E/199

Substances

Index number

EC number

CAS number

Notes

Naphtha (petroleum), light alkylate; Low boiling point modified naphtha

649-276-00-X

265-068-8

64741-66-8

P

(A complex combination of hydrocarbons produced by distillation of the
reaction products of isobutane with monoolefinic hydrocarbons usually
ranging in carbon numbers from C3 through C5. It consists of predomi-
nantly branched chain saturated hydro-carbons having carbon numbers
predominantly in the range of C7 through C10 and boiling in the range of
approximately 90 °C to 160 °C.)

Naphtha (petroleum), isomerisation; Low boiling point modified naphtha

649-277-00-5

265-073-5

64741-70-4

P

(A complex combination of hydrocarbons obtained from catalytic isomer-
isation of straight chain paraffinic C4 through C6 hydrocarbons. It consists
predominantly of saturated hydrocarbons such as isobutane, isopentane,
2,2-dimethylbutane, 2-methylpentane, and 3-methylpentane.)

Naphtha (petroleum), solvent-refined light; Low boiling point modified
naphtha

(A complex combination of hydrocarbons obtained as the raffinate from
a solvent extraction process. It consists predominantly of aliphatic hydro-
carbons having carbon numbers predominantly in the range of C5
through C11 and boiling in the range of approximately 35 °C to 190 °C.)

649-278-00-0

265-086-6

64741-84-0

P

Naphtha (petroleum), solvent-refined heavy; Low boiling point modified
naphtha

(A complex combination of hydrocarbons obtained as the raffinate from
a solvent extraction process. It consists predominantly of aliphatic hydro-
carbons having carbon numbers predominantly in the range of C7
through C12 and boiling in the range of approximately 90 °C to 230 °C.)

649-279-00-6

265-095-5

64741-92-0

P

Raffinates (petroleum), catalytic reformer ethylene glycol-water counter-
current exts.; Low boiling point modified naphtha

(A complex combination of hydrocarbons obtained as the raffinate from
the UDEX extraction process on the catalytic reformer stream. It consists
of saturated hydrocarbons having carbon numbers predominantly in the
range of C6 through C9.)

649-280-00-1

270-088-5

68410-71-9

P

Raffinates (petroleum), reformer, Lurgi unit-sepd.; Low boiling point
modified naphtha

(The complex combination of hydrocarbons obtained as a raffinate from
a Lurgi separation unit. It consists predominantly of non-aromatic hydro-
carbons with various small amounts of aromatic hydrocarbons having
carbon numbers predominantly in the range of C6 through C8.)

649-281-00-7

270-349-3

68425-35-4

P

C 276E/200

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Naphtha (petroleum), full-range alkylate, butane-contg.; Low boiling point
modified naphtha

(A complex combination of hydrocarbons produced by the distillation of
the reaction products of
isobutane with monoolefinic hydrocarbons
usually ranging in carbon numbers from C3 through C5. It consists of
predominantly branched chain saturated hydrocarbons having carbon
numbers predominantly in the range of C7 through C12 with some
butanes and boiling in the range of approximately 35 °C to 200 °C.)

649-282-00-2

271-267-0

68527-27-5

P

Distillates (petroleum), naphtha steam cracking-derived, solvent-refined
light hydrotreated; Low boiling point modified naphtha

(A complex combination of hydrocarbons obtained as the raffinates from
a solvent extraction process of hydrotreated light distillate from steam-
cracked naphtha.)

649-283-00-8

295-315-5

91995-53-8

P

Naphtha (petroleum), C4-12 butane-alkylate,
point modified naphtha

isooctane-rich; Low boiling

649-284-00-3

295-430-0

92045-49-3

P

(A complex combination of hydrocarbons obtained by alkylation of
butanes.
It consists predominantly of hydrocarbons having carbon
numbers predominantly in the range of C4 through C12, rich in isooctane,
and boiling in the range of approximately 35 °C to 210 °C.)

Hydrocarbons, hydrotreated light naphtha distillates, solvent-refined; Low
boiling point modified naphtha

(A combination of hydrocarbons obtained from the distillation of hydro-
treated naphtha followed by a solvent extraction and distillation process.
It consists predominantly of saturated hydrocarbons boiling in the range
of approximately 94 °C to 99 °C.)

649-285-00-9

295-436-3

92045-55-1

P

Naphtha (petroleum), isomerisation, C6-fraction; Low boiling point modi-
fied naphtha

(A complex combination of hydrocarbons obtained by distillation of a
gasoline which has been catalytically isomerised. It consists predominantly
of hexane isomers boiling in the range of approximately 60 °C to 66 °C.)

649-286-00-4

295-440-5

92045-58-4

P

Hydrocarbons, C6-7, naphtha-cracking, solvent-refined; Low boiling point
modified naphtha

(A complex combination of hydrocarbons obtained by the sorption of
benzene from a catalytically fully hydrogenated benzene-rich hydrocarbon
cut
that was distillatively obtained from prehydrogenated cracked
naphtha. It consists predominantly of paraffinic and naphthenic hydrocar-
bons having carbon numbers predominantly in the range of C6 through
C7 and boiling in the range of approximately 70 °C to 100 °C.)

Hydrocarbons, C6-rich, hydrotreated light naphtha distillates, solvent-
refined; Low boiling point modified naphtha

(A complex combination of hydrocarbons obtained by distillation of
hydrotreated naphtha followed by solvent extraction. It consists predomi-
nantly of saturated hydrocarbons and boiling in the range of approxi-
mately 65 °C to 70 °C.)

649-287-00-X

295-446-8

92045-64-2

P

649-288-00-5

309-871-4

101316-67-0

P

14.11.2006

EN

Official Journal of the European Union

C 276E/201

Substances

Index number

EC number

CAS number

Notes

Naphtha (petroleum), heavy catalytic cracked; Low boiling point cat-
cracked naphtha

(A complex combination of hydrocarbons produced by a distillation of
products from a catalytic cracking process. It consists of hydrocarbons
having carbon numbers predominantly in the range of C6 through C12
and boiling in the range of approximately 65 °C to 230 °C. It contains a
relatively large proportion of unsaturated hydrocarbons.)

649-289-00-0

265-055-7

64741-54-4

P

Naphtha (petroleum),
cracked naphtha

light catalytic cracked; Low boiling point cat-

649-290-00-6

265-056-2

64741-55-5

P

(A complex combination of hydrocarbons produced by the distillation of
products from a catalytic cracking process. It consists of hydrocarbons
having carbon numbers predominantly in the range of C4 through C11
and boiling in the range of approximately -20 °C to 190 °C. It contains a
relatively large proportion of unsaturated hydrocarbons.)

Hydrocarbons, C3-11, catalytic cracker distillates; Low boiling point cat-
cracked naphtha

(A complex combination of hydrocarbons produced by the distillations of
products from a catalytic cracking process. It consists of hydrocarbons
having carbon numbers predominantly in the range of C3 through C11
and boiling in a range approximately up to 204 °C.)

649-291-00-1

270-686-6

68476-46-0

P

Naphtha (petroleum), catalytic cracked light distd.; Low boiling point cat-
cracked naphtha

(A complex combination of hydrocarbons produced by the distillation of
products from a catalytic cracking process. It consists of hydrocarbons
having carbon numbers predominantly in the range of C1 through C5.)

649-292-00-7

272-185-8

68783-09-5

P

Distillates (petroleum), naphtha steam cracking-derived, hydrotreated light
arom.; Low boiling point cat-cracked naphtha

(A complex combination of hydrocarbons obtained by treating a light
distillate from steam-cracked naphtha.
It consists predominantly of
aromatic hydrocarbons.)

649-293-00-2

295-311-3

91995-50-5

P

Naphtha (petroleum), heavy catalytic cracked, sweetened; Low boiling
point cat-cracked naphtha

(A complex combination of hydrocarbons obtained by subjecting a cata-
lytic cracked petroleum distillate to a sweetening process to convert
mercaptans or to remove acidic impurities. It consists predominantly of
hydrocarbons having carbon numbers predominantly in the range of C6
through C12 and boiling in the range of approximately 60 °C to 200 °C.)

Naphtha (petroleum), light catalytic cracked sweetened; Low boiling point
cat-cracked naphtha

(A complex combination of hydrocarbons obtained by subjecting naphtha
from a catalytic cracking process to a sweetening process to convert
mercaptans or to remove acidic impurities. It consists predominantly of
hydrocarbons boiling in a range of approximately 35 °C to 210 °C.)

649-294-00-8

295-431-6

92045-50-6

P

649-295-00-3

295-441-0

92045-59-5

P

C 276E/202

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Hydrocarbons, C8-12, catalytic-cracking, chem. neutralised; Low boiling
point cat-cracked naphtha

(A complex combination of hydrocarbons produced by the distillation of
a cut from the catalytic cracking process, having undergone an alkaline
washing.
It consists predominantly of hydrocarbons having carbon
numbers in the range of C8 through C12 and boiling in the range of
approximately 130 °C to 210 °C.)

Hydrocarbons, C8-12, catalytic cracker distillates; Low boiling point cat-
cracked naphtha

(A complex combination of hydrocarbons obtained by distillation of
products from a catalytic cracking process. It consists predominantly of
hydrocarbons having carbon numbers predominantly in the range of C8
through C12 and boiling in the range of approximately 140 °C to 210 °C.)

649-296-00-9

295-794-0

92128-94-4

P

649-297-00-4

309-974-4

101794-97-2

P

Hydrocarbons, C8-12, catalytic cracking, chem. neutralised, sweetened; Low
boiling point cat-cracked naphtha

649-298-00-X

309-987-5

101896-28-0

Naphtha (petroleum),
reformed naphtha

light catalytic reformed; Low boiling point cat-

649-299-00-5

265-065-1

64741-63-5

P

P

(A complex combination of hydrocarbons produced from the distillation
of products from a catalytic reforming process. It consists of hydrocar-
bons having carbon numbers predominantly in the range of C5 through
C11 and boiling in the range of approximately 35 °C to 190 °C. It contains
a relatively large proportion of aromatic and branched chain hydrocar-
bons. This stream may contain 10 vol. % or more benzene.)

Naphtha (petroleum), heavy catalytic reformed; Low boiling point cat-
reformed naphtha

(A complex combination of hydrocarbons produced from the distillation
of products from a catalytic reforming process. It consists of predomi-
nantly aromatic hydrocarbons having numbers predominantly in the
range of C7 through C12 and boiling in the range of approximately 90 °C
to 230 °C.)

Distillates (petroleum), catalytic reformed depentaniser; Low boiling point
cat-reformed naphtha

(A complex combination of hydrocarbons
from the distillation of
products from a catalytic reforming process. It consists predominantly of
aliphatic hydrocarbons having carbon numbers predominantly in the
range of C3 through C6 and boiling in the range of approximately -49 °C
to 63 °C.)

649-300-00-9

265-070-9

64741-68-0

P

649-301-00-4

270-660-4

68475-79-6

P

Hydrocarbons, C2-6, C6-8 catalytic reformer; Low boiling point cat-
reformed naphtha

649-302-00-X

270-687-1

68476-47-1

Residues (petroleum), C6-8 catalytic reformer; Low boiling point cat-
reformed naphtha

(A complex residuum from the catalytic reforming of C6-8 feed. It consists
of hydrocarbons having carbon numbers predominantly in the range of
C2 through C6.)

649-303-00-5

270-794-3

68478-15-9

P

P

14.11.2006

EN

Official Journal of the European Union

C 276E/203

Substances

Index number

EC number

CAS number

Notes

Naphtha (petroleum),
point cat-reformed naphtha

light catalytic reformed, arom.-free; Low boiling

(A complex combination of hydrocarbons obtained from distillation of
products from a catalytic reforming process. It consists predominantly of
hydrocarbons having carbon numbers predominantly in the range of C5
through C8 and boiling in the range of approximately 35 °C to 120 °C. It
contains a relatively large proportion of branched chain hydrocarbons
with the aromatic components removed.)

649-304-00-0

270-993-5

68513-03-1

P

Distillates (petroleum), catalytic reformed straight-run naphtha overheads;
Low boiling point cat-reformed naphtha

(A complex combination of hydrocarbons obtained by the catalytic
reforming of straight-run naphtha followed by the fractionation of the
total effluent.
It consists of saturated aliphatic hydrocarbons having
carbon numbers predominantly in the range of C2 through C6.)

649-305-00-6

271-008-1

68513-63-3

P

Petroleum products, hydrofiner-powerformer reformates; Low boiling
point cat-reformed naphtha

(The complex combination of hydrocarbons obtained in a hydrofiner-
powerformer process and boiling in a range of approximately 27 °C to
210 °C.)

649-306-00-1

271-058-4

68514-79-4

P

Naphtha (petroleum, full-range reformed; Low boiling point cat-reformed
naphtha

(A complex combination of hydrocarbons produced by the distillation of
the products from a catalytic reforming process. It consists of hydrocar-
bons having carbon numbers predominantly in the range of C5 through
C12 and boiling in the range of approximately 35 °C to 230 °C.)

649-307-00-7

272-895-8

68919-37-9

P

Naphtha (petroleum), catalytic reformed; Low boiling point cat-reformed
naphtha

(A complex combination of hydrocarbons produced by the distillation of
products from a catalytic reforming process. It consists of hydrocarbons
having carbon numbers predominantly in the range of C4 through C12
and boiling in the range of approximately 30 °C to 220 °C. It contains a
relatively large proportion of aromatic and branched chain hydrocarbons.
This stream may contain 10 vol. % or more benzene.)

649-308-00-2

273-271-8

68955-35-1

P

Distillates (petroleum), catalytic reformed hydrotreated light, C8-12 arom.
fraction; Low boiling point cat-reformed naphtha

(A complex combination of alkylbenzenes obtained by the catalytic
reforming of petroleum naphtha. It consists predominantly of alkylben-
zenes having carbon numbers predominantly in the range of C8 through
C10 and boiling in the range of approximately 160 °C to 180 °C.)

649-309-00-8

285-509-8

85116-58-1

P

C 276E/204

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Aromatic hydrocarbons, C8, catalytic reforming-derived; Low boiling
point cat-reformed naphtha

649-310-00-3

295-279-0

91995-18-5

649-311-00-9

297-401-8

93571-75-6

P

P

Aromatic hydrocarbons, C7-12, C8-rich; Low boiling point cat-reformed
naphtha

(A complex combination of hydrocarbons obtained by separation from
the platformate-containing fraction. It consists predominantly of aromatic
hydrocarbons having carbon numbers predominantly in the range of C7
through C12 (primarily C8) and can contain nonaromatic hydrocarbons,
both boiling in the range of approximately 130 °C to 200 °C.)

Gasoline, C5-11, high-octane stabilised reformed; Low boiling point cat-
reformed naphtha

(A complex high octane combination of hydrocarbons obtained by the
It
catalytic dehydrogenation of a predominantly naphthenic naphtha.
consists predominantly of aromatics and non-aromatics having carbon
numbers predominantly in the range of C5 through C11 and boiling in the
range of approximately 45 °C to 185 °C.)

Hydrocarbons, C7-12, C > 9–arom.-rich, reforming heavy fraction; Low
boiling point cat-reformed naphtha

(A complex combination of hydrocarbons obtained by separation from
the platformate-containing fraction. It consists predominantly of nonaro-
matic hydrocarbons having carbon numbers predominantly in the range
of C7 through C12 and boiling in the range of approximately 120 °C to
210 °C and C9 and higher aromatic hydrocarbons.)

Hydrocarbons, C5-11, nonaroms.-rich, reforming light fraction; Low boiling
point cat-reformed naphtha

(A complex combination of hydrocarbons obtained by separation from
the platformate-containing fraction. It consists predominantly of nonaro-
matic hydrocarbons having carbon numbers predominantly in the range
of C5 to C11 and boiling in the range of approximately 35 °C to 125 °C,
benzene and toluene.)

649-312-00-4

297-458-9

93572-29-3

P

649-313-00-X

297-465-7

93572-35-1

P

649-314-00-5

297-466-2

93572-36-2

P

Foots oil (petroleum), silicic acid-treated; Foots oil

649-315-00-0

308-127-6

97862-77-6

L

(A complex combination of hydrocarbons obtained by the treatment of
Foots oil with silicic acid for removal of trace constituents and impurities.
It consists predominantly of straight chain hydrocarbons having carbon
numbers predominantly greater than C12.)

Naphtha (petroleum), light thermal cracked; Low boiling point thermally
cracked naphtha

(A complex combination of hydrocarbons from distillation of products
from a thermal cracking process. It consists predominantly of unsaturated
hydrocarbons having carbon numbers predominantly in the range of C4
through C8 and boiling in the range of approximately – 10 °C to 130 °C.)

649-316-00-6

265-075-6

64741-74-8

P

14.11.2006

EN

Official Journal of the European Union

C 276E/205

Substances

Index number

EC number

CAS number

Notes

Naphtha (petroleum), heavy thermal cracked; Low boiling point thermally
cracked naphtha

(A complex combination of hydrocarbons from distillation of products
from a thermal cracking process. It consists predominantly of unsaturated
hydrocarbons having carbon numbers predominantly in the range of C6
through C12 and boiling in the range of approximately 65 °C to 220 °C.)

Distillates (petroleum), heavy arom.; Low boiling point thermally cracked
naphtha

(The complex combination of hydrocarbons from the distillation of
products from the thermal cracking of ethane and propane. This higher
boiling fraction consists predominantly of C5-C7 aromatic hydrocarbons
with some unsaturated aliphatic hydrocarbons having a carbon number
predominantly of C5. This stream may contain benzene.)

Distillates (petroleum), light arom.; Low boiling point thermally cracked
naphtha

(The complex combination of hydrocarbons from the distillation of
products from the thermal cracking of ethane and propane. This lower
boiling fraction consists predominantly of C5-C7 aromatic hydrocarbons
with some unsaturated aliphatic hydrocarbons having a carbon number
predominantly of C5. This stream may contain benzene.)

Distillates
blending; Low boiling point thermally cracked naphtha

(petroleum), naphtha-raffinate pyrolyzate-derived, gasoline-

(The complex combination of hydrocarbons obtained by the pyrolysis
fractionation at 816 °C of naphtha and raffinate. It consists predominantly
of hydrocarbons having a carbon number of C9 and boiling at approxi-
mately 204 °C.)

Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived; Low
boiling point thermally cracked naphtha

(A complex combination of hydrocarbons obtained by the fractionation
pyrolysis at 816 °C of naphtha and raffinate. It consists predominantly of
aromatic hydrocarbons having carbon numbers predominantly in the
range of C6 through C8, including benzene.)

Distillates (petroleum), thermal cracked naphtha and gas oil; Low boiling
point thermally cracked naphtha

(A complex combination of hydrocarbons produced by distillation of
thermally cracked naphtha and/or gas oil. It consists predominantly of
olefinic hydrocarbons having a carbon number of C5 and boiling in the
range of approximately 33 °C to 60 °C.)

Distillates (petroleum), thermal cracked naphtha and gas oil, C5-dimer-
contg.; Low boiling point thermally cracked naphtha

(A complex combination of hydrocarbons produced by the extractive
distillation of thermal cracked naphtha and/or gas oil. It consists predomi-
nantly of hydrocarbons having a carbon number of C5 with some
dimerised C5 olefins and boiling in the range of approximately 33 °C to
184 °C.)

649-317-00-1

265-085-0

64741-83-9

P

649-318-00-7

267-563-4

67891-79-6

P

649-319-00-2

267-565-5

67891-80-9

P

649-320-00-8

270-344-6

68425-29-6

P

649-321-00-3

270-658-3

68475-70-7

P

649-322-00-9

271-631-9

68603-00-9

P

649-323-00-4

271-632-4

68603-01-0

P

C 276E/206

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Distillates (petroleum), thermal cracked naphtha and gas oil, extractive;
Low boiling point thermally cracked naphtha

(A complex combination of hydrocarbons produced by the extractive
distillation of thermal cracked naphtha and/or gas oil. It consists of paraf-
finic and olefinic hydrocarbons predominantly isoamylenes such as 2-
methyl-1-butene and 2-methyl-2-butene and boiling in the range of
approximately 31 °C to 40 °C.)

649-324-00-X

271-634-5

68603-03-2

P

Distillates (petroleum),
boiling point thermally cracked naphtha

light thermal cracked, debutanised arom.; Low

(A complex combination of hydrocarbons produced by the distillation of
products from a thermal cracking process. It consists predominantly of
aromatic hydrocarbons, primarily benzene.)

649-325-00-5

273-266-0

68955-29-3

P

Naphtha (petroleum), light thermal cracked, sweetened; Low boiling point
thermally cracked naphtha

(A complex combination of hydrocarbons obtained by subjecting a petro-
leum distillate from the high temperature thermal cracking of heavy oil
fractions to a sweetening process to convert mercaptans.
It consists
predominantly of aromatics, olefins and saturated hydrocarbons boiling
in the range of approximately 20 °C to 100 °C.)

Naphtha (petroleum), hydrotreated heavy; Low boiling point hydrogen
treated naphtha

(A complex combination of hydrocarbons obtained by treating a petro-
leum fraction with hydrogen in the presence of a catalyst. It consists of
hydrocarbons having carbon numbers predominantly in the range of C6
through C13 and boiling in the range of approximately 65 °C to 230 °C.)

Naphtha (petroleum), hydrotreated light; Low boiling point hydrogen
treated naphtha

(A complex combination of hydrocarbons obtained by treating a petro-
leum fraction with hydrogen in the presence of a catalyst. It consists of
hydrocarbons having carbon numbers predominantly in the range of C4
through C11 and boiling in the range of approximately -20 °C to 190 °C.)

Naphtha (petroleum), hydrodesulphurised light; Low boiling point
hydrogen treated naphtha

(A complex combination of hydrocarbons obtained from a catalytic
hydrodesulphurisation process. It consists of hydrocarbons having carbon
numbers predominantly in the range of C4 through C11 and boiling in the
range of approximately -20 °C to 190 °C.)

Naphtha (petroleum), hydrodesulphurised heavy; Low boiling point
hydrogen treated naphtha

(A complex combination of hydrocarbons obtained from a catalytic
hydrodesulphurisation process. It consists of hydrocarbons having carbon
numbers predominantly in the range of C7 through C12 and boiling in the
range of approximately 90 °C to 230 °C.)

649-326-00-0

295-447-3

92045-65-3

P

649-327-00-6

265-150-3

64742-48-9

P

649-328-00-1

265-151-9

64742-49-0

P

649-329-00-7

265-178-6

64742-73-0

P

649-330-00-2

265-185-4

64742-82-1

P

14.11.2006

EN

Official Journal of the European Union

C 276E/207

Substances

Index number

EC number

CAS number

Notes

Distillates (petroleum), hydrotreated middle,
boiling point hydrogen treated naphtha

intermediate boiling; Low

649-331-00-8

270-092-7

68410-96-8

P

(A complex combination of hydrocarbons obtained by the distillation of
products from a middle distillate hydrotreating process. It consists of
hydrocarbons having carbon numbers predominantly in the range of C5
through C10 and boiling in the range of approximately 127 °C to 188 °C.)

Distillates (petroleum), light distillate hydrotreating process, low-boiling;
Low boiling point hydrogen treated naphtha

(A complex combination of hydrocarbons obtained by the distillation of
products from the light distillate hydrotreating process.
It consists of
hydrocarbons having carbon numbers predominantly in the range of C6
through C9 and boiling in the range of approximately 3 °C to 194 °C.)

649-332-00-3

270-093-2

68410-97-9

P

Distillates (petroleum), hydrotreated heavy naphtha, deisohexaniser over-
heads; Low boiling point hydrogen treated naphtha

(A complex combination of hydrocarbons obtained by distillation of the
products from a heavy naphtha hydrotreating process.
It consists of
hydrocarbons having carbon numbers predominantly in the range of C3
through C6 and boiling in the range of approximately – 49 °C to 68 °C.)

649-333-00-9

270-094-8

68410-98-0

P

Solvent naphtha (petroleum), light arom., hydrotreated; Low boiling point
hydrogen treated naphtha

(A complex combination of hydrocarbons obtained by treating a petro-
leum fraction with hydrogen in the presence of a catalyst. It consists
predominantly of aromatic hydrocarbons having carbon numbers predo-
minantly in the range of C8 through C10 and boiling in the range of
approximately 135 °C to 210 °C.)

649-334-00-4

270-988-8

68512-78-7

P

Naphtha (petroleum), hydrodesulphurised thermal cracked light; Low
boiling point hydrogen treated naphtha

(A complex combination of hydrocarbons obtained by fractionation of
hydrodesulphurised thermal cracker distillate. It consists predominantly of
hydrocarbons having carbon numbers predominantly in the range of C5
to C11 and boiling in the range of approximately 23 °C to 195 °C.)

649-335-00-X

285-511-9

85116-60-5

P

Naphtha (petroleum), hydrotreated light, cycloalkane-contg.; Low boiling
point hydrogen treated naphtha

(A complex combination of hydrocarbons obtained from the distillation
of a petroleum fraction. It consists predominantly of alkanes and cycloalk-
anes boiling in the range of approximately – 20 °C to 190 °C.)

649-336-00-5

285-512-4

85116-61-6

P

Naphtha (petroleum), heavy steam-cracked, hydrogenated; Low boiling
point hydrogen treated naphtha

649-337-00-0

295-432-1

92045-51-7

P

C 276E/208

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Naphtha (petroleum), hydrodesulphurised full-range; Low boiling point
hydrogen treated naphtha

(A complex combination of hydrocarbons obtained from a catalytic
hydrodesulphurisation process. It consists predominantly of hydrocarbons
having carbon numbers predominantly in the range of C4 through C11
and boiling in the range of approximately 30 °C to 250 °C.)

649-338-00-6

295-433-7

92045-52-8

P

649-339-00-1

295-438-4

92045-57-3

P

649-340-00-7

295-443-1

92045-61-9

P

649-341-00-2

295-529-9

92062-15-2

P

649-342-00-8

296-942-7

93165-55-0

P

Naphtha (petroleum), hydrotreated light steam-cracked; Low boiling point
hydrogen treated naphtha

(A complex combination of hydrocarbons obtained by treating a petro-
leum fraction, derived from a pyrolysis process, with hydrogen in the
presence of a catalyst. It consists predominantly of unsaturated hydrocar-
bons having carbon numbers predominantly in the range of C5 through
C11 and boiling in the range of approximately 35 °C to 190 °C.)

Hydrocarbons, C4-12, naphtha-cracking, hydrotreated; Low boiling point
hydrogen treated naphtha

(A complex combination of hydrocarbons obtained by distillation from
the product of naphtha steam cracking process and subsequent catalytic
selective hydrogenation of gum formers.
It consists of hydrocarbons
having carbon numbers predominantly in the range of C4 through C12
and boiling in the range of approximately 30 °C to 230 °C.)

Solvent naphtha (petroleum), hydrotreated light naphthenic; Low boiling
point hydrogen treated naphtha

(A complex combination of hydrocarbons obtained by treating a petro-
leum fraction with hydrogen in the presence of a catalyst. It consists
predominantly of cycloparaffinic hydrocarbons having carbon numbers
predominantly in the range of C6 through C7 and boiling in the range of
approximately 73 °C to 85 °C.)

Naphtha (petroleum),
point hydrogen treated naphtha

light steam-cracked, hydrogenated; Low boiling

(A complex combination of hydrocarbons produced from the separation
the products of a steam-cracking
and subsequent hydrogenation of
process to produce ethylene. It consists predominantly of saturated and
unsaturated paraffins, cyclic paraffins and cyclic aromatic hydrocarbons
having carbon numbers predominantly in the range of C4 through C10
and boiling in the range of approximately 50 °C to 200 °C. The propor-
tion of benzene hydrocarbons may vary up to 30 wt. % and the stream
may also contain small amounts of sulphur and oxygenated compounds.)

Hydrocarbons, C6-11, hydrotreated, dearomatised; Low boiling point
hydrogen treated naphtha

(A complex combination of hydrocarbons obtained as solvents which
have been subjected to hydrotreatment in order to convert aromatics to
naphthenes by catalytic hydrogenation.)

649-343-00-3

297-852-0

93763-33-8

P

14.11.2006

EN

Official Journal of the European Union

C 276E/209

Substances

Index number

EC number

CAS number

Notes

Hydrocarbons, C9-12, hydrotreated, dearomatised; Low boiling point
hydrogen treated naphtha

(A complex combination of hydrocarbons obtained as solvents which
have been subjected to hydrotreatment in order to convert aromatics to
naphthenes by catalytic hydrogenation.)

649-344-00-9

297-853-6

93763-34-9

P

Stoddard solvent; Low boiling point naphtha — unspecified

649-345-00-4

232-489-3

8052-41-3

P

(A colourless, refined petroleum distillate that is free from rancid or objec-
tionable odours and that boils in a range of approximately 149 °C to
205 °C.)

Natural gas condensates (petroleum); Low boiling point naphtha —
unspecified

(A complex combination of hydrocarbons separated as a liquid from
natural gas in a surface separator by retrograde condensation. It consists
mainly of hydrocarbons having carbon numbers predominantly in the
range of C2 to C20. It is a liquid at atmospheric temperature and pressure.)

Natural gas (petroleum), raw liq. mix; Low boiling point naphtha —
unspecified

(A complex combination of hydrocarbons separated as a liquid from
natural gas in a gas recycling plant by processes such as refrigeration or
absorption. It consists mainly of saturated aliphatic hydrocarbons having
carbon numbers in the range of C2 through C8.)

Naphtha (petroleum), light hydrocracked; Low boiling point naphtha —
unspecified

the
(A complex combination of hydrocarbons
products from a hydrocracking process. It consists predominantly of satu-
rated hydrocarbons having carbon numbers predominantly in the range
of C4 through C10, and boiling in the range of approximately – 20 °C to
180 °C.)

from distillation of

Naphtha (petroleum) heavy hydrocracked; Low boiling point naphtha —
unspecified

(A complex combination of hydrocarbons
the
products from a hydrocracking process. It consists predominantly of satu-
rated hydrocarbons having carbon numbers predominantly in the range
of C6 through C12, and boiling in the range of approximately 65 °C to
230 °C.)

from distillation of

Naphtha (petroleum), sweetened; Low boiling point naphtha — unspeci-
fied

(A complex combination of hydrocarbons obtained by subjecting a petro-
leum naphtha to a sweetening process to convert mercaptans or to
remove acidic impurities.
It consists of hydrocarbons having carbon
numbers predominantly in the range of C4 through C12 and boiling in the
range of approximately -10 °C to 230 °C.)

649-346-00-X

265-047-3

64741-47-5

P

649-347-00-5

265-048-9

64741-48-6

P

649-348-00-0

265-071-4

64741-69-1

P

649-349-00-6

265-079-8

64741-78-2

P

649-350-00-1

265-089-2

64741-87-3

P

C 276E/210

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Naphtha (petroleum), acid-treated; Low boiling point naphtha — unspeci-
fied

(A complex combination of hydrocarbons obtained as a raffinate from a
sulphuric acid treating process. It consists of hydrocarbons having carbon
numbers predominantly in the range of C7 through C12 and boiling in the
range of approximately 90 °C to 230 °C.)

649-351-00-7

265-115-2

64742-15-0

P

Naphtha (petroleum), chemically neutralised heavy; Low boiling point
naphtha — unspecified

(A complex combination of hydrocarbons produced by a treating process
to remove acidic materials. It consists of hydrocarbons having carbon
numbers predominantly in the range of C6 through C12 and boiling in the
range of approximately 65 °C to 230 °C.)

649-352-00-2

265-122-0

64742-22-9

P

Naphtha (petroleum), chemically neutralised light; Low boiling point
naphtha — unspecified

(A complex combination of hydrocarbons produced by a treating process
to remove acidic materials. It consists of hydrocarbons having carbon
numbers predominantly in the range of C4 through C11 and boiling in the
range of approximately -20 °C to 190 °C.)

649-353-00-8

265-123-6

64742-23-0

P

Naphtha (petroleum), catalytic dewaxed; Low boiling point naphtha —
unspecified

(A complex combination of hydrocarbons obtained from the catalytic
dewaxing of a petroleum fraction. It consists predominantly of hydrocar-
bons having carbon numbers predominantly in the range of C5 through
C12 and boiling in the range of approximately 35 °C to 230 °C.)

649-354-00-3

265-170-2

64742-66-1

P

Naphtha (petroleum), light steam-cracked; Low boiling point naphtha —
unspecified

(A complex combination of hydrocarbons obtained by the distillation of
the products from a steam cracking process. It consists predominantly of
unsaturated hydrocarbons having carbon numbers predominantly in the
range of C4 through C11 and boiling in the range of approximately -20 °C
to 190 °C. This stream is likely to contain 10 vol. % or more benzene.)

649-355-00-9

265-187-5

64742-83-2

P

Solvent naphtha (petroleum), light arom.; Low boiling point naphtha —
unspecified

(A complex combination of hydrocarbons obtained from distillation of
aromatic streams. It consists predominantly of aromatic hydrocarbons
having carbon numbers predominantly in the range of C8 through C10
and boiling in the range of approximately 135 °C to 210 °C.)

649-356-00-4

265-199-0

64742-95-6

P

Aromatic hydrocarbons, C6-10, acid-treated, neutralised; Low boiling point
naphtha — unspecified

649-357-00-X

268-618-5

68131-49-7

P

14.11.2006

EN

Official Journal of the European Union

C 276E/211

Substances

Index number

EC number

CAS number

Notes

Distillates (petroleum), C3-5, 2-methyl-2-butene-rich; Low boiling point
naphtha — unspecified

(A complex combination of hydrocarbons from the distillation of hydro-
carbons usually ranging in carbon numbers from C3 through C5, predomi-
nantly isopentane and 3-methyl-1-butene. It consists of saturated and
unsaturated hydrocarbons having carbon numbers in the range of C3
through C5, predominantly 2-methyl-2-butene.)

Distillates (petroleum), polymd. steam-cracked petroleum distillates, C5-12
fraction; Low boiling point naphtha — unspecified

(A complex combination of hydrocarbons obtained from the distillation
of polymerised steam-cracked petroleum distillate. It consists predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of C5 through C12.)

Distillates (petroleum), steam-cracked, C5-12 fraction; Low boiling point
naphtha — unspecified

(A complex combination of organic compounds obtained by the distilla-
tion of products from a steam cracking process. It consists of unsaturated
hydrocarbons having carbon numbers predominantly in the range of C5
through C12.)

649-358-00-5

270-725-7

68477-34-9

P

649-359-00-0

270-735-1

68477-50-9

P

649-360-00-6

270-736-7

68477-53-2

P

Distillates (petroleum), steam-cracked, C5-10 fraction, mixed with light
steam-cracked petroleum naphtha C5 fraction; Low boiling point naphtha
— unspecified

649-361-00-1

270-738-8

68477-55-4

P

Extracts (petroleum), cold-acid, C4-6; Low boiling point naphtha — unspe-
cified

(A complex combination of organic compounds produced by cold acid
unit extraction of saturated and unsaturated aliphatic hydrocarbons
usually ranging in carbon numbers from C3 through C6, predominantly
pentanes and amylenes. It consists predominantly of saturated and unsa-
turated hydrocarbons having carbon numbers in the range of C4 through
C6, predominantly C5.)

649-362-00-7

270-741-4

68477-61-2

P

Distillates
naphtha — unspecified

(petroleum), depentaniser overheads; Low boiling point

(A complex combination of hydrocarbons obtained from a catalytic
cracked gas stream. It consists of aliphatic hydrocarbons having carbon
numbers predominantly in the range of C4 through C6.)

649-363-00-2

270-771-8

68477-894-4

P

Residues (petroleum), butane splitter bottoms; Low boiling point naphtha
— unspecified

(A complex residuum from the distillation of butane stream. It consists of
aliphatic hydrocarbons having carbon numbers predominantly in the
range of C4 through C6.)

649-364-00-8

270-791-7

68478-12-6

P

C 276E/212

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Residual oils
naphtha — unspecified

(petroleum), deisobutaniser

tower; Low boiling point

649-365-00-3

270-795-9

68478-16-0

P

(A complex residuum from the atmospheric distillation of the butane-
butylene stream.
It consists of aliphatic hydrocarbons having carbon
numbers predominantly in the range of C4 through C6.)

Naphtha (petroleum), full-range coker; Low boiling point naphtha —
unspecified

(A complex combination of hydrocarbons produced by the distillation of
products from a fluid coker. It consists predominantly of unsaturated
hydrocarbons having carbon numbers predominantly in the range of C4
through C15 and boiling in the range of approximately 43 °C to 250 °C.)

Naphtha (petroleum), steam-cracked middle arom.; Low boiling point
naphtha — unspecified

(A complex combination of hydrocarbons produced by the distillation of
products from a steam-cracking process. It consists predominantly of
aromatic hydrocarbons having carbon numbers predominantly in the
range of C7 through C12 and boiling in the range of approximately 130 °C
to 220 °C.)

Naphtha (petroleum), clay-treated full-range straight-run; Low boiling
point naphtha — unspecified

(A complex combination of hydrocarbons resulting from treatment of
full-range straight-run, naphtha with natural or modified clay, usually in a
percolation process to remove the trace amounts of polar compounds
and impurities present.
It consists of hydrocarbons having carbon
numbers predominantly in the range of C4 through C11 and boiling in the
range of approximately -20 °C to 220 °C.)

Naphtha (petroleum), clay-treated light straight-run; Low boiling point
naphtha — unspecified

(A complex combination of hydrocarbons resulting from treatment of
light straight-run naphtha with a natural or modified clay, usually in a
percolation process to remove the trace amounts of polar compounds
and impurities, present.
It consists of hydro-carbons having carbon
numbers predominantly in the range of C7 through C10 and boiling in the
range of approximately 93 °C to 180 °C.)

649-366-00-9

270-991-4

68513-02-0

P

649-367-00-4

271-138-9

68516-20-1

P

649-368-00-X

271-262-3

68527-21-9

P

649-369-00-5

271-263-9

68527-22-0

P

Naphtha (petroleum),
naphtha — unspecified

light steam-cracked arom.; Low boiling point

649-370-00-0

271-264-4

68527-23-1

P

(A complex combination of hydrocarbons produced by distillation of
products from a steam-cracking process. It consists predominantly of
aromatic hydrocarbons having carbon numbers predominantly in the
range of C7 through C9, and boiling in the range of approximately 110 °C
to 165 °C.)

Naphtha (petroleum),
point naphtha — unspecified

light steam-cracked, debenzenised; Low boiling

(A complex combination of hydrocarbons produced by distillation of
products from a steam-cracking process. It consists predominantly of
hydrocarbons having carbon numbers predominantly in the range of C4
through C12 and boiling in the range of approximately 80 °C to 218 °C.)

649-371-00-6

271-266-5

68527-26-4

P

14.11.2006

EN

Official Journal of the European Union

C 276E/213

Substances

Index number

EC number

CAS number

Notes

Naphtha (petroleum), arom.-contg.; Low boiling point naphtha — unspe-
cified

649-372-00-1

271-635-0

68603-08-7

Gasoline, pyrolysis, debutaniser bottoms; low boiling point naphtha —
unspecified

(A complex combination of hydrocarbons obtained from the fractionation
of depropaniser bottoms.
It consists of hydrocarbons having carbon
numbers predominantly greater than C5.)

649-373-00-7

271-726-5

68606-10-0

P

P

Naphtha (petroleum),
unspecified

light, sweetened; Low boiling point naphtha —

649-374-00-2

272-206-0

68783-66-4

P

(A complex combination of hydrocarbons obtained by subjecting a petro-
leum distillate to a sweetening process to convert mercaptans or to
remove acidic impurities. It consists predominantly of saturated and unsa-
turated hydrocarbons having carbon numbers predominantly in the range
of C3 through C6 and boiling in the range of approximately -20 °C to
100 °C.)

Natural gas condensates; Low boiling point naphtha — unspecified

649-375-00-8

272-896-3

68919-39-1

J

(A complex combination of hydrocarbons separated and/or condensed
from natural gas during transportation and collected at the wellhead and/
or from the production, gathering, transmission, and distribution pipe-
lines in deeps, scrubbers, etc. It consists predominantly of hydrocarbons
having carbon numbers predominantly in the range of C2 through C8.)

Distillates (petroleum), naphtha unifiner stripper; Low boiling point
naphtha — unspecified

(A complex combination of hydrocarbons produced by stripping the
products from the naphtha unifiner.
It consists of saturated aliphatic
hydrocarbons having carbon numbers predominantly in the range of C2
through C6.)

Naphtha (petroleum), catalytic reformed light, arom.-free fraction; Low
boiling point naphtha — unspecified

(A complex combination of hydrocarbons remaining after removal of
aromatic compounds from catalytic reformed light naphtha in a selective
It consists predominantly of paraffinic and cyclic
absorption process.
compounds having carbon numbers predominantly in the range of C5 to
C8 and boiling in the range of approximately 66 °C to 121 °C.)

649-376-00-3

272-932-8

68921-09-5

P

649-377-00-9

285-510-3

85116-59-2

P

Gasoline; Low boiling point naphtha — unspecified

649-378-00-4

289-220-8

86290-81-5

P

(A complex combination of hydrocarbons consisting primarily of paraf-
fins, cycloparaffins, aromatic and olefinic hydrocarbons having carbon
numbers predominantly greater than C3 and boiling in the range of 30 °C
to 260 °C.)

Aromatic hydrocarbons, C7-8, dealkylation products, distn. residues; Low
boiling point naphtha — unspecified

649-379-00-X

292-698-0

90989-42-7

P

C 276E/214

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Hydrocarbons, C4-6, depentaniser lights, arom. hydrotreater; Low boiling
point naphtha — unspecified

(A complex combination of hydrocarbons obtained as first runnings from
the depentaniser column before hydrotreatment of the aromatic charges.
It consists predominantly of hydrocarbons having carbon numbers predo-
minantly in the range of C4 through C6, predominantly pentanes and
pentenes, and boiling in the range of approximately 25 °C to 40 °C.)

649-380-00-5

295-298-4

91995-38-9

P

Distillates (petroleum), heat-soaked steam-cracked naphtha, C5-rich; Low
boiling point naphtha — unspecified

(A complex combination of hydrocarbons obtained by distillation of heat-
soaked steam-cracked naphtha. It consists predominantly of hydrocarbons
having carbon numbers in the range of C4 through C6, predominantly C5.)

649-381-00-0

295-302-4

91995-41-4

P

Extracts (petroleum), catalytic reformed light naphtha solvent; low boiling
point naphtha — unspecified

(A complex combination of hydrocarbons obtained as the extract from
the solvent extraction of a catalytically reformed petroleum cut. It consists
predominantly of aromatic hydrocarbons having carbon numbers predo-
minantly in the range of C7 through C8 and boiling in the range of
approximately 100 °C to 200 °C.)

649-382-00-6

295-331-2

91995-68-5

P

Naphtha (petroleum), hydrodesulphurised light, dearomatised; low boiling
point naphtha — unspecified

(A complex combination of hydrocarbons obtained by distillation of
hydrodesulphurised and dearomatised light petroleum fractions.
It
consists predominantly of C7 paraffins and cycloparaffins boiling in a
range of approximately 90 °C to 100 °C.)

649-383-00-1

295-434-2

92045-53-9

P

Naphtha (petroleum), light, C5-rich, sweetened; low boiling point naphtha
— unspecified

(A complex combination of hydrocarbons obtained by subjecting a petro-
leum naphtha to a sweetening process to convert mercaptans or to
remove acidic impurities.
It consists of hydrocarbons having carbon
numbers predominantly in the range of C4 through C5, predominantly C5,
and boiling in the range of approximately -10 °C to 35 °C.)

649-384-00-7

295-442-6

92045-60-8

P

Hydrocarbons, C8-11, naphtha-cracking,
naphtha — unspecified

toluene cut;

low boiling point

649-385-00-2

295-444-7

92045-62-0

P

(A complex combination of hydrocarbons obtained by distillation from
prehydrogenated cracked naphtha. It consists predominantly of hydrocar-
bons having carbon numbers predominantly in the range of C8 through
C11 and boiling in the range of approximately 130 °C to 205 °C.)

14.11.2006

EN

Official Journal of the European Union

C 276E/215

Substances

Index number

EC number

CAS number

Notes

Hydrocarbons, C4-11, naphtha-cracking; arom.-free;
naphtha — unspecified

low boiling point

649-386-00-8

295-445-2

92045-63-1

P

(A complex combination of hydrocarbons obtained from prehydroge-
nated cracked naphtha after distillative separation of benzene- and
toluene-containing hydrocarbon cuts and a higher boiling fraction.
It
consists predominantly of hydrocarbons having carbon numbers predo-
minantly in the range of C4 through C11 and boiling in the range of
approximately 30 °C to 205 °C.)

Naphtha (petroleum), light heat-soaked, steam-cracked; low boiling point
naphtha — unspecified

(A complex combination of hydrocarbons obtained by the fractionation
of steam cracked naphtha after recovery from a heat soaking process. It
consists predominantly of hydrocarbons having carbon numbers predo-
minantly in the range of C4 through C6 and boiling in the range of
approximately 0 °C to 80 °C.)

649-387-00-3

296-028-8

92201-97-3

P

Distillates (petroleum), C6-rich; low boiling point naphtha — unspecified
(A complex combination of hydrocarbons obtained from the distillation
of a petroleum feedstock.
It consists predominantly of hydrocarbons
having carbon numbers of C5 through C7, rich in C6, and boiling in the
range of approximately 60 °C to 70 °C.)

649-388-00-9

296-903-4

93165-19-6

P

Gasoline, pyrolysis, hydrogenated; low boiling point naphtha — unspeci-
fied

(A distillation fraction from the hydrogenation of pyrolysis gasoline
boiling in the range of approximately 20 °C to 200 °C.)

649-389-00-4

302-639-3

94114-03-1

P

Distillates (petroleum), steam-cracked, C8-12 fraction, polymd., distn. lights;
low boiling point naphtha — unspecified

(A complex combination of hydrocarbons obtained by distillation of the
polymerised C8 through C12 fraction from steam-cracked petroleum distil-
lates. It consists predominantly of aromatic hydrocarbons having carbon
numbers predominantly in the range of C8 through C12.)

649-390-00-X

305-750-5

95009-23-7

P

Extracts (petroleum); heavy naphtha solvent, clay-treated;
point naphtha — unspecified

low boiling

649-391-00-5

308-261-5

97926-43-7

P

(A complex combination of hydrocarbons obtained by the treatment of
heavy naphthic solvent petroleum extract with bleaching earth. It consists
predominantly of hydrocarbons having carbon numbers predominantly in
the range of C6 through C10, and boiling in the range of approximately
80 °C to 180 °C.)

Naphtha
treated; low boiling point naphtha — unspecified

(petroleum),

light

steam-cracked, debenzenised,

thermally

649-392-00-0

308-713-1

98219-46-6

P

(A complex combination of hydrocarbons obtained by the treatment and
distillation of debenzenised light steam-cracked petroleum naphtha.
It
consists predominantly of hydrocarbons having carbon numbers predo-
minantly in the range of C7 through C12 and boiling in the range of
approximately 95 °C to 200 °C.)

C 276E/216

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Naphtha (petroleum), light steam-cracked, thermally treated; low boiling
point naphtha — unspecified

(A complex combination of hydrocarbons obtained by the treatment and
distillation of light steam-cracked petroleum naphtha. It consists predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of C5 through C6 and boiling in the range of approximately 35 °C
to 80 °C.)

Distillates (petroleum), C7-9, C8-rich, hydrodesulphurised dearomatised;
low boiling point naphtha — unspecified

(A complex combination of hydrocarbons obtained by the distillation of
petroleum light fraction, hydrodesulphurised and dearomatised. It consists
predominantly of hydrocarbons having carbon numbers in the range of
C7 through C9, predominantly C8 paraffins and cycloparaffins, boiling in
the range of approximately 120 °C to 130 °C.)

Hydrocarbons, C6-8, hydrogenated sorption-dearomatised, toluene raffina-
tion; low boiling point naphtha — unspecified

(A complex combination of hydrocarbons obtained during the sorption
of toluene from a hydrocarbon fraction from cracked gasoline treated
with hydrogen in the presence of a catalyst. It consists predominantly of
hydrocarbons having carbon numbers predominantly in the range of C6
through C8 and boiling in the range of approximately 80 °C to 135 °C.)

649-393-00-6

308-714-7

98219-47-7

P

649-394-00-1

309-862-5

101316-56-7

P

649-395-00-7

309-870-9

101316-66-9

P

Naphtha (petroleum), hydrodesulphurised full-range coker;
point naphtha — unspecified

low boiling

649-396-00-2

309-879-8

101316-76-1

P

(A complex combination of hydrocarbons obtained by fractionation from
hydrodesulphurised coker distillate. It consists predominantly of hydrocar-
bons having carbon numbers predominantly in the range of C5 to C11 and
boiling in the range of approximately 23 °C to 196 °C.)

Naphtha (petroleum), sweetened light;
unspecified

low boiling point naphtha —

649-397-00-8

309-976-5

101795-01-1

P

(A complex combination of hydrocarbons obtained by subjecting a petro-
leum naphtha to a sweetening process to convert mercaptans or to
It consists predominantly of hydrocarbons
remove acidic impurities.
having carbon numbers predominantly in the range of C5 through C8 and
boiling in the range of approximately 20 °C to 130 °C.)

Hydrocarbons, C3-6, C5-rich, steam-cracked naphtha;
naphtha — unspecified

low boiling point

649-398-00-3

310-012-0

102110-14-5

P

(A complex combination of hydrocarbons obtained by distillation of
steam-cracked naphtha. It consists predominantly of hydrocarbons having
carbon numbers in the range of C3 through C6, predominantly C5.)

Hydrocarbons, C5-rich, dicyclopentadiene-contg.;
naphtha — unspecified

low boiling point

649-399-00-9

310-013-6

102110-15-6

P

(A complex combination of hydrocarbons obtained by distillation of the
products from a steam-cracking process. It consists predominantly of
hydrocarbons having carbon numbers of C5 and dicyclopentadiene and
boiling in the range of approximately 30 °C to 170 °C.)

14.11.2006

EN

Official Journal of the European Union

C 276E/217

Substances

Index number

EC number

CAS number

Notes

Residues (petroleum), steam-cracked light, arom.;
naphtha — unspecified

low boiling point

649-400-00-2

310-057-6

102110-55-4

P

(A complex combination of hydrocarbons obtained by the distillation of
the products of steam cracking or similar processes after taking off the
very light products resulting in a residue starting with hydrocarbons
having carbon numbers greater than C5. It consists predominantly of
aromatic hydrocarbons having carbon numbers greater than C5 and
boiling above approximately 40 °C.)

Hydrocarbons, C ≥ 5, C5-6-rich; low boiling point naphtha — unspecified

649-401-00-8

270-690-8

68476-50-6

Hydrocarbons, C5-rich; low boiling point naphtha — unspecified

649-402-00-3

270-695-5

68476-55-1

Aromatic hydrocarbons, C8-10; Light oil redistillate, high boiling

649-403-00-9

292-695-4

90989-39-2

Distillates (petroleum), light catalytic cracked; Cracked gas oil

649-435-00-3

265-060-4

64741-59-9

(A complex combination of hydrocarbons produced by the distillation of
products from a catalytic cracking process. It consists of hydrocarbons
having carbon numbers predominantly in the range of C9 through C25
and boiling in the range of approximately 150 °C to 400 °C. It contains a
relatively large proportion of bicyclic aromatic hydrocarbons.)

P

P

P

Distillates (petroleum), intermediate catalytic cracked; Cracked gas oil

649-436-00-9

265-062-5

64741-60-2

(A complex combination of hydrocarbons produced by the distillation of
products from a catalytic cracking process. It consists of hydrocarbons
having carbon numbers predominantly in the range of C11 through C30
and boiling in the range of approximately 205 °C to 450 °C. It contains a
relatively large proportion of tricyclic aromatic hydrocarbons.)

Distillates (petroleum), light thermal cracked; Cracked gas oil

649-438-00-X

265-084-5

64741-82-8

(A complex combination of hydrocarbons from the distillation of the
products from a thermal cracking process. It consists predominantly of
unsaturated hydrocarbons having carbon numbers predominantly in the
range of C10 through C22 and boiling in the range of approximately
160 °C to 370 °C.)

Distillates
Cracked gas oil

(petroleum), hydrodesulphurised light

catalytic

cracked;

649-439-00-5

269-781-5

68333-25-5

(A complex combination of hydrocarbons obtained by treating light cata-
lytic cracked distillates with hydrogen to convert organic sulphur to
hydrogen sulphide which is removed. It consists of hydrocarbons having
carbon numbers predominantly in the range of C9 through C25 and
boiling in the range of approximately 150 °C to 400 °C. It contains a rela-
tively large proportion of bicyclic aromatic hydrocarbons.)

C 276E/218

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Distillates (petroleum), light steam-cracked naphtha; Cracked gas oil

649-440-00-0

270-662-5

68475-80-9

(A complex combination of hydrocarbons from the multiple distillation
of products from a steam cracking process. It consists of hydrocarbons
having carbon numbers predominantly in the range of C10 through C18.)

Distillates
Cracked gas oil

(petroleum),

cracked steam-cracked petroleum distillates;

649-441-00-6

270-727-8

68477-38-3

(A complex combination of hydrocarbons produced by distilling cracked
steam cracked distillate and/or its fractionation products. It consists of
hydrocarbons having carbon numbers predominantly in the range of C10
to low molecular weight polymers.)

Gas oils (petroleum), steam-cracked; Cracked gas oil

649-442-00-1

271-260-2

68527-18-4

(A complex combination of hydrocarbons produced by distillation of the
products from a steam cracking process.
It consists of hydrocarbons
having carbon numbers predominantly greater than C9 and boiling in the
range of from approximately 205 °C to 400 °C.)

Distillates
Cracked gas oil

(petroleum), hydrodesulphurised thermal

cracked middle;

649-443-00-7

285-505-6

85116-53-6

(A complex combination of hydrocarbons obtained by fractionation from
hydrodesulphurised thermal cracker distillate stocks. It consists predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of C11 to C25 and boiling in the range of from approximately 205 °C
to 400 °C.)

Gas oils (petroleum), thermal-cracked, hydrodesulphurised; Cracked gas
oil

649-444-00-2

295-411-7

92045-29-9

Residues (petroleum), hydrogenated steam-cracked naphtha; Cracked gas
oil

(A complex combination of hydrocarbons obtained as a residual fraction
from the distillation of hydrotreated steam-cracked naphtha. It consists
predominantly of hydrocarbons boiling in the range of approximately
200 °C to 350 °C.)

649-445-00-8

295-514-7

92062-00-5

Residues (petroleum), steam-cracked naphtha distn.; Cracked gas oil

649-446-00-3

295-517-3

92062-04-9

(A complex combination of hydrocarbons obtained as a column bottom
from the separation of effluents from steam cracking naphtha at a high
temperature. It boils in the range of approximately 147 °C to 300 °C and
produces a finished oil having a viscosity of 18 10-6 m2·s-1 at 50 °C.)

Distillates
Cracked gas oil

(petroleum),

light

catalytic

cracked,

thermally degraded;

649-447-00-9

295-991-1

92201-60-0

(A complex combination of hydrocarbons produced by the distillation of
products from a catalytic cracking process which has been used as a heat
transfer fluid. It consists predominantly of hydrocarbons boiling in the
range of approximately 190 °C to 340 °C. This steam is likely to contain
organic sulphur compounds.)

14.11.2006

EN

Official Journal of the European Union

C 276E/219

Substances

Index number

EC number

CAS number

Notes

Residues (petroleum), steam-cracked, heat-soaked naphtha; Cracked gas
oil

(A complex combination of hydrocarbons obtained as residue from the
distillation of steam-cracked heat-soaked naphtha and boiling in the range
of approximately 150 °C to 350 °C.)

649-448-00-4

297-905-8

93763-85-0

Gas oils (petroleum), light vacuum, thermal-cracked hydrodesulphurised;
Cracked gas oil

(A complex combination of hydrocarbons obtained by catalytic dehydro-
sulphurisation of thermal-cracked light vacuum petroleum.
It consists
predominantly of hydrocarbons having carbon numbers predominantly in
the range of C14 through C20 and boiling in the range of approximately
270 °C to 370 °C.)

649-450-00-5

308-278-8

97926-59-5

Distillates (petroleum), hydrodesulphurised middle coker; Cracked gas oil

649-451-00-0

309-865-1

101316-59-0

(A complex combination of hydrocarbons by fractionation from hydrode-
sulphurised coker distillate stocks. It consists of hydrocarbons having
carbon numbers predominantly in the range of C12 through C21 and
boiling in the range of approximately 200 °C to 360 °C.)

Distillates (petroleum), heavy steam-cracked; Cracked gas oil

649-452-00-6

309-939-3

101631-14-5

(A complex combination of hydrocarbons obtained by distillation of
steam cracking heavy residues. It consists predominantly of highly alky-
lated heavy aromatic hydrocarbons boiling in the range of approximately
250 °C to 400 °C.)

Distillates (petroleum), heavy hydrocracked; Base oil — unspecified

649-453-00-1

265-077-7

64741-76-0

L

(A complex combination of hydrocarbons from the distillation of the
products from a hydrocracking process. It consists predominantly of satu-
rated hydrocarbons having carbon numbers in the range of C15 through
C39 and boiling in the range of approximately 260 °C to 600 °C.)

Distillates (petroleum), solvent-refined heavy paraffinic; Base oil — unspe-
cified

(A complex combination of hydrocarbons obtained as the raffinate from
a solvent extraction process. It consists predominantly of saturated hydro-
carbons having carbon numbers predominantly in the range of C20
through C50 and produces a finished oil with a viscosity of at least 19 10-
6 m2·s-1 at 40 °C.)

Distillates (petroleum), solvent-refined light paraffinic; Base oil — unspeci-
fied

(A complex combination of hydrocarbons obtained as the raffinate from
a solvent extraction process. It consists predominantly of saturated hydro-
carbons having carbon numbers predominantly in the range of C15
through C30 and produces a finished oil having a viscosity of less than
19 10-6 m2·s-1 at 40 °C.)

649-454-00-7

265-090-8

64741-88-4

L

649-455-00-2

265-091-3

64741-89-5

L

C 276E/220

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Residual oils (petroleum), solvent deasphalted; Base oil — unspecified

649-456-00-8

265-096-0

64741-95-3

L

(A complex combination of hydrocarbons obtained as the solvent soluble
fraction from C3-C4 solvent deasphalting of a residuum. It consists of
hydrocarbons having carbon numbers predominantly higher than C25 and
boiling above approximately 400 °C.)

Distillates (petroleum), solvent-refined heavy naphthenic; Base oil —
unspecified

(A complex combination of hydrocarbons obtained as the raffinate from
a solvent extraction process. It consists of hydrocarbons having carbon
numbers predominantly in the range of C20 through C50 and produces a
finished oil with a viscosity of at least 19 10-6 m2·s-1 at 40 °C. It contains
relatively few normal paraffins.)

Distillates (petroleum), solvent-refined light naphthenic; Base oil — unspe-
cified

(A complex combination of hydrocarbons obtained as the raffinate from
a solvent extraction process. It consists of hydrocarbons having carbon
numbers predominantly in the range of C15 through C30 and produces a
finished oil with a viscosity of less than 19 10-6 m2·s-1 at 40 °C. It
contains relatively few normal paraffins.)

649-457-00-3

265-097-6

64741-96-4

L

649-458-00-9

265-098-1

64741-97-5

L

Residual oils (petroleum), solvent-refined; Base oil — unspecified

649-459-00-4

265-101-6

64742-01-4

L

(A complex combination of hydrocarbons obtained as the solvent inso-
luble fraction from solvent refining of a residuum using a polar organic
solvent such as phenol or furfural. It consists of hydrocarbons having
than C25 and boiling above
carbon numbers predominantly greater
approximately 400 °C.)

Distillates (petroleum), clay-treated paraffinic; Base oil — unspecified

649-460-00-X

265-137-2

64742-36-5

L

(A complex combination of hydrocarbons resulting from treatment of a
petroleum fraction with natural or modified clay in either a contacting or
percolation process to remove the trace amounts of polar compounds
and impurities present.
It consists of hydrocarbons having carbon
numbers predominantly in the range of C20 through C50 and produces a
finished oil with a viscosity of at least 19 10-6 m2·s-1 at 40 °C. It contains
a relatively large proportion of saturated hydrocarbons.)

Distillates (petroleum), clay-treated light paraffinic; Base oil — unspecified

649-461-00-5

265-138-8

64742-37-6

L

(A complex combination of hydrocarbons resulting from treatment of a
petroleum fraction with natural or modified clay in either a contacting or
percolation process to remove the trace amounts of polar compounds
and impurities present.
It consists of hydrocarbons having carbon
numbers predominantly in the range of C15 through C30 and produces a
finished oil with a viscosity of less than 19 10-6 m2·s-1 at 40 °C. It
contains a relatively large proportion of saturated hydrocarbons.)

14.11.2006

EN

Official Journal of the European Union

C 276E/221

Substances

Index number

EC number

CAS number

Notes

Residual oils (petroleum), clay-treated; Base oil — unspecified

649-462-00-0

265-143-5

64742-41-2

L

(A complex combination of hydrocarbons obtained by the treatment of a
residual oil with a natural or modified clay in either a contacting or
percolation process to remove the trace amounts of polar compounds
and impurities present.
It consists of hydrocarbons having carbon
numbers predominantly greater than C25 and boiling above approximately
400 °C.)

Distillates (petroleum), clay-treated heavy naphthenic; Base oil — unspeci-
fied

(A complex combination of hydrocarbons resulting from treatment of a
petroleum fraction with a natural or modified clay in either a contacting
or percolation process to remove the trace amounts of polar compounds
and impurities present.
It consists of hydrocarbons having carbon
numbers predominantly in the range of C20 through C50 and produces a
finished oil with a viscosity of at least 19 10-6 m2·s-1 at 40 °C. It contains
relatively few normal paraffins.)

Distillates (petroleum), clay-treated light naphthenic; Base oil — unspeci-
fied

(A complex combination of hydrocarbons resulting from treatment of a
petroleum fraction with natural or modified clay in either a contacting or
percolation process to remove the trace amounts of polar compounds
and impurities present.
It consists of hydrocarbons having carbon
numbers predominantly in the range of C15 through C30 and produces a
finished oil with a viscosity of less than 19 10-6 m2·s-1 at 40 °C. It
contains relatively few normal paraffins.)

Distillates (petroleum), hydrotreated heavy naphthenic; Base oil — unspe-
cified

(A complex combination of hydrocarbons obtained by treating a petro-
leum fraction with hydrogen in the presence of a catalyst. It consists of
hydrocarbons having carbon numbers predominantly in the range of C20
through C50 and produces a finished oil with a viscosity of at least 19 10-
6 m2·s-1 at 40 °C. It contains relatively few normal paraffins.)

Distillates (petroleum), hydrotreated light naphthenic; Base oil — unspeci-
fied

(A complex combination of hydrocarbons obtained by treating a petro-
leum fraction with hydrogen in the presence of a catalyst. It consists of
hydrocarbons having carbon numbers predominantly in the range of C15
through C30 and produces a finished oil with a viscosity of less than 19
10-6 m2·s-1 at 40 °C. It contains relatively few normal paraffins.)

Distillates (petroleum), hydrotreated heavy paraffinic; Base oil — unspeci-
fied

(A complex combination of hydrocarbons obtained by treating a petro-
leum fraction with hydrogen in the presence of a catalyst. It consists of
hydrocarbons having carbon numbers predominantly in the range of C20
through C50 and produces a finished oil of at least 19 10-6 m2·s-1 at 40 °C.
It contains a relatively large proportion of saturated hydrocarbons.)

649-463-00-6

265-146-1

64742-44-5

L

649-464-00-1

265-147-7

64742-45-6

L

649-465-00-7

265-155-0

64742-52-5

L

649-466-00-2

265-156-6

64742-53-6

L

649-467-00-8

265-157-1

64742-54-7

L

C 276E/222

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Distillates (petroleum), hydrotreated light paraffinic; Base oil — unspeci-
fied

(A complex combination of hydrocarbons obtained by treating a petro-
leum fraction with hydrogen in the presence of a catalyst. It consists of
hydrocarbons having carbon numbers predominantly in the range of C15
through C30 and produces a finished oil with a viscosity of less than 19
10-6 m2·s-1 at 40 °C. It contains a relatively large proportion of saturated
hydrocarbons.)

649-468-00-3

265-158-7

64742-55-8

L

Distillates (petroleum), solvent-dewaxed light paraffinic; Base oil — unspe-
cified

(A complex combination of hydrocarbons obtained by removal of normal
paraffins from a petroleum fraction by solvent crystallisation. It consists
predominantly of hydrocarbons having carbon numbers predominantly in
the range of C15 through C30 and produces a finished oil with a viscosity
of less than 19 10-6 m2·s-1 at 40 °C.)

649-469-00-9

265-159-2

64742-56-9

L

Residual oils (petroleum), hydrotreated; Base oil — unspecified

649-470-00-4

265-160-8

64742-57-0

L

(A complex combination of hydrocarbons obtained by treating a petro-
leum fraction with hydrogen in the presence of a catalyst. It consists of
hydrocarbons having carbon numbers predominantly greater than C25
and boiling above approximately 400 °C.)

Residual oils (petroleum), solvent-dewaxed; Base oil — unspecified

649-471-00-X

265-166-0

64742-62-7

L

(A complex combination of hydrocarbons obtained by removal of long,
branched chain hydrocarbons from a residual oil by solvent crystallisa-
tion. It consists of hydrocarbons having carbon numbers predominantly
greater than C25 and boiling above approximately 400 °C.)

Distillates (petroleum), solvent-dewaxed heavy naphthenic; Base oil —
unspecified

(A complex combination of hydrocarbons obtained by removal of normal
paraffins from a petroleum fraction by solvent crystallisation. It consists
of hydrocarbons having carbon numbers predominantly in the range of
C20 through C50 and produces a finished oil of not less than 19 10-6 m2·s-
1 at 40 °C. It contains relatively few normal paraffins.)

649-472-00-5

265-167-6

64742-63-8

L

Distillates (petroleum), solvent-dewaxed light naphthenic; Base oil —
unspecified

(A complex combination of hydrocarbons obtained by removal of normal
paraffins from a petroleum fraction by solvent crystallisation. It consists
of hydrocarbons having carbon numbers predominantly in the range of
C15 through C30 and produces a finished oil with a viscosity of less than
19 10-6 m2·s-1 at 40 °C. It contains relatively few normal paraffins.)

649-473-00-0

265-168-1

64742-64-9

L

14.11.2006

EN

Official Journal of the European Union

C 276E/223

Substances

Index number

EC number

CAS number

Notes

Distillates (petroleum), solvent-dewaxed heavy paraffinic; Base oil —
unspecified

(A complex combination of hydrocarbons obtained by removal of normal
paraffins from a petroleum fraction by solvent crystallisation. It consists
predominantly of hydrocarbons having carbon numbers predominantly in
the range of C20 through C50 and produces a finished oil with a viscosity
of not less than 19 10-6 m2·s-1 at 40 °C.)

Naphthenic oils (petroleum), catalytic dewaxed heavy; Base oil — unspeci-
fied

(A complex combination of hydrocarbons obtained from a catalytic
dewaxing process.
It consists predominantly of hydrocarbons having
carbon numbers predominantly in the range of C20 through C50 and
produces a finished oil with a viscosity of at least 19 10-6 m2·s-1 at 40 °C.
It contains relatively few normal paraffins.)

Naphthenic oils (petroleum), catalytic dewaxed light; Base oil — unspeci-
fied

(A complex combination of hydrocarbons obtained from a catalytic
dewaxing process. It consists of hydrocarbons having carbon numbers
predominantly in the range of C15 through C30 and produces a finished
oil with a viscosity of less than 19 10-6 m2·s-1 at 40 °C. It contains rela-
tively few normal paraffins.)

649-474-00-6

265-169-7

64742-65-0

L

649-475-00-1

265-172-3

64742-68-3

L

649-476-00-7

265-173-9

64742-69-4

L

Paraffin oils (petroleum), catalytic dewaxed heavy; Base oil — unspecified

649-477-00-2

265-174-4

64742-70-7

L

(A complex combination of hydrocarbons obtained from a catalytic
dewaxing process.
It consists predominantly of hydrocarbons having
carbon numbers predominantly in the range of C20 through C50 and
produces a finished oil with a viscosity of at least 19 10-6 m2·s-1 at 40 °C.)

Paraffin oils (petroleum), catalytic dewaxed light; Base oil — unspecified

649-478-00-8

265-176-5

64742-71-8

L

(A complex combination of hydrocarbons obtained from a catalytic
dewaxing process.
It consists predominantly of hydrocarbons having
carbon numbers predominantly in the range of C15 through C30 and
produces a finished oil with a viscosity of less than 19 10-6 m2·s-1 at
40 °C.)

Naphthenic oils (petroleum), complex dewaxed heavy; Base oil — unspe-
cified

(A complex combination of hydrocarbons obtained by removing straight
chain paraffin hydrocarbons as a solid by treatment with an agent such as
urea. It consists of hydrocarbons having carbon numbers predominantly
in the range of C20 through C50 and produces a finished oil with a visc-
osity of at least 19 10-6 m2·s-1 at 40 °C. It contains relatively few normal
paraffins.)

Naphthenic oils (petroleum), complex dewaxed light; Base oil — unspeci-
fied

(A complex combination of hydrocarbons obtained from a catalytic
dewaxing process. It consists of hydrocarbons having carbon numbers
predominantly in the range of C15 through C30 and produces a finished
oil having a viscosity less than 19 10-6 m2·s-1 at 40 °C. It contains rela-
tively few normal paraffins.)

649-479-00-3

265-179-1

64742-75-2

L

649-480-00-9

265-180-7

64742-76-3

L

C 276E/224

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

649-481-00-4

276-736-3

72623-85-9

L

649-482-00-X

276-737-9

72623-86-0

L

649-483-00-5

276-738-4

72623-87-1

L

Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based high-
viscosity; Base oil — unspecified

(A complex combination of hydrocarbons obtained by treating light
vacuum gas oil, heavy vacuum gas oil, and solvent deasphalted residual
oil with hydrogen in the presence of a catalyst in a two stage process
It consists
with dewaxing being carried out between the two stages.
predominantly of hydrocarbons having carbon numbers predominantly in
the range of C20 through C50 and produces a finished oil having a visc-
osity of approximately 112 10-6 m2·s-1 at 40 °C. It contains a relatively
large proportion of saturated hydrocarbons.)

Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based; Base
oil — unspecified

(A complex combination of hydrocarbons obtained by treating light
vacuum gas oil and heavy vacuum gas oil with hydrogen in the presence
of a catalyst in a two stage process with dewaxing being carried out
between the two stages. It consists predominantly of hydrocarbons having
carbon numbers predominantly in the range of C15 through C30 and
produces a finished oil having a viscosity of approximately 15 10-6 m2·s-1
at 40 °C. It contains a relatively large proportion of saturated hydrocar-
bons.)

Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based; Base
oil — unspecified

(A complex combination of hydrocarbons obtained by treating light
vacuum gas oil, heavy vacuum gas oil and solvent deasphalted residual oil
with hydrogen in the presence of a catalyst in a two stage process with
dewaxing being carried out between the two stages. It consists predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of C20 through C50 and produces a finished oil with a viscosity of
It contains a relatively large
approximately 32 10-6 m2·s-1 at 40 °C.
proportion of saturated hydrocarbons.)

Lubricating oils; Base oil — unspecified

649-484-00-0

278-012-2

74869-22-0

L

(A complex combination of hydrocarbons obtained from solvent extrac-
tion and dewaxing processes.
It consists predominantly of saturated
hydrocarbons having carbon numbers in the range of C15 through C50.)

Distillates (petroleum), complex dewaxed heavy paraffinic; Base oil —
unspecified

(A complex combination of hydrocarbons obtained by dewaxing heavy
paraffinic distillate.
It consists predominantly of hydrocarbons having
carbon numbers predominantly in the range of C20 through C50 and
produces a finished oil with a viscosity of equal to or greater than 19 10-
6 m2·s-1 at 40 °C. It contains relatively few normal paraffins.)

Distillates (petroleum), complex dewaxed light paraffinic; Base oil —
unspecified

(A complex combination of hydrocarbons obtained by dewaxing light
paraffinic distillate.
It consists predominantly of hydrocarbons having
carbon numbers predominantly in the range of C12 through C30 and
produces a finished oil with a viscosity of less than 19 10-6 m2·s-1 at
40 °C. It contains relatively few normal paraffins.)

649-485-00-6

292-613-7

90640-91-8

L

649-486-00-1

292-614-2

90640-92-9

L

14.11.2006

EN

Official Journal of the European Union

C 276E/225

Substances

Index number

EC number

CAS number

Notes

Distillates (petroleum), solvent-dewaxed heavy paraffinic, clay-treated;
Base oil — unspecified

(A complex combination of hydrocarbons obtained by treating dewaxed
heavy paraffinic distillate with neutral or modified clay in either a
contacting or percolation process. It consists predominantly of hydrocar-
bons having carbon numbers predominantly in the range of C20 through
C50.)

Hydrocarbons, C20-50, solvent-dewaxed heavy paraffinic, hydrotreated;
Base oil — unspecified

(A complex combination of hydrocarbons produced by treating dewaxed
heavy paraffinic distillate with hydrogen in the presence of a catalyst. It
consists predominantly of hydrocarbons having carbon numbers predo-
minantly in the range of C20 through C50.)

Distillates (petroleum), solvent dewaxed light paraffinic, clay-treated; Base
oil — unspecified

(A complex combination of hydrocarbons resulting from treatment of
dewaxed light paraffinic distillate with natural or modified clay in either a
contacting or percolation process. It consists predominantly of hydrocar-
bons having carbon numbers predominantly in the range of C15 through
C30.)

Distillates (petroleum), solvent dewaxed light paraffinic, hydrotreated;
Base oil — unspecified

(A complex combination of hydrocarbons produced by treating a
dewaxed light paraffinic distillate with hydrogen in the presence of a cata-
lyst. It consists of hydrocarbons having carbon numbers predominantly in
the range of C15 through C30.)

649-487-00-7

292-616-3

90640-94-1

L

649-488-00-2

292-617-9

90640-95-2

L

649-489-00-8

292-618-4

90640-96-3

L

649-490-00-3

292-620-5

90640-97-4

L

Residual oils (petroleum), hydrotreated solvent dewaxed; Base oil —
unspecified

649-491-00-9

292-656-1

90669-74-2

Residual oils (petroleum), catalytic dewaxed; Base oil — unspecified

649-492-00-4

294-843-3

91770-57-9

649-493-00-X

295-300-3

91995-39-0

L

L

L

Distillates (petroleum), dewaxed heavy paraffinic, hydrotreated; Base oil
— unspecified

(A complex combination of hydrocarbons obtained from an intensive
treatment of dewaxed distillate by hydrogenation in the presence of a
catalyst.
It consists predominantly of saturated hydrocarbons having
carbon numbers in the range of C25 through C39 and produces a finished
oil with a viscosity of approximately 44 10-6 m2·s-1 at 50 °C.)

Distillates (petroleum), dewaxed light paraffinic, hydrotreated; Base oil —
unspecified

(A complex combination of hydrocarbons obtained from an intensive
treatment of dewaxed distillate by hydrogenation in the presence of a
catalyst.
It consists predominantly of saturated hydrocarbons having
carbon numbers in the range of C21 through C29 and produces a finished
oil with a viscosity of approximately 13 10-6 m2·s-1 at 50 °C.)

649-494-00-5

295-301-9

91995-40-3

L

C 276E/226

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Distillates (petroleum), hydrocracked solvent-refined, dewaxed; Base oil —
unspecified

(A complex combination of liquid hydrocarbons obtained by recrystallisa-
tion of dewaxed hydrocracked solvent-refined petroleum distillates.)

649-495-00-0

295-306-6

91995-45-8

L

Distillates (petroleum), solvent-refined light naphthenic, hydrotreated;
Base oil — unspecified

(A complex combination of hydrocarbons obtained by treating a petro-
leum fraction with hydrogen in the presence of a catalyst and removing
the aromatic hydrocarbons by solvent extraction. It consists predomi-
nantly of naphthenic hydrocarbons having carbon numbers predomi-
nantly in the range of C15 through C30 and produces a finished oil with a
viscosity of between 13-15 10-6 m2·s-1 at 40 °C.)

649-496-00-6

295-316-0

91995-54-9

L

Lubricating oils (petroleum) C17-35, solvent-extd., dewaxed, hydrotreated;
Base oil — unspecified

649-497-00-1

295-423-2

92045-42-6

Lubricating oils (petroleum), hydrocracked nonarom. solvent-deparaffined;
Base oil — unspecified

649-498-00-7

295-424-8

92045-43-7

Residual oils (petroleum), hydrocracked acid-treated solvent-dewaxed;
Base oil — unspecified

(A complex combination of hydrocarbons produced by solvent removal
of paraffins from the residue of the distillation of acid-treated, hydro-
cracked heavy paraffins and boiling approximately above 380 °C.)

649-499-00-2

295-499-7

92061-86-4

L

L

L

Paraffin oils (petroleum), solvent-refined dewaxed heavy; Base oil —
unspecified

(A complex combination of hydrocarbons obtained from sulphur-
containing paraffinic crude oil. It consists predominantly of a solvent
refined deparaffinated lubricating oil with a viscosity of 65 10-6 m2·s-1 at
50 °C.)

649-500-00-6

295-810-6

92129-09-4

L

Lubricating oils (petroleum), base oils, paraffinic; Base oil — unspecified

649-501-00-1

297-474-6

93572-43-1

L

(A complex combination of hydrocarbons obtained by refining crude oil.
It consists predominantly of aromatics, naphthenics and paraffinics and
produces a finished oil with a viscosity of 23 10-6 m2·s-1 at 40 °C.)

Hydrocarbons, hydrocracked paraffinic distn. residues, solvent-dewaxed;
Base oil — unspecified

649-502-00-7

297-857-8

93763-38-3

Hydrocarbons, C20-50, residual oil hydrogenation vacuum distillate; Base
oil — unspecified

649-503-00-2

300-257-1

93924-61-9

Distillates (petroleum), solvent-refined hydrotreated heavy; hydrogenated;
Base oil — unspecified

649-504-00-8

305-588-5

94733-08-1

L

L

L

14.11.2006

EN

Official Journal of the European Union

C 276E/227

Substances

Index number

EC number

CAS number

Notes

Distillates (petroleum), solvent-refined hydrocracked light; Base oil —
unspecified

(A complex combination of hydrocarbons obtained by solvent dearomati-
sation of the residue of hydrocracked petroleum. It consists predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of C18 through C27 and boiling in the range of approximately
370 °C to 450 °C.)

Lubricating oils (petroleum), C18, solvent-dewaxed hydrocracked distillate-
bas-40ed; Base oil — unspecified

(A complex combination of hydrocarbons obtained by solvent deparaffi-
nation of the distillation residue from hydrocracked petroleum. It consists
predominantly of hydrocarbons having carbon numbers predominantly in
the range of C18 through C40 and boiling in the range of approximately
370 °C to 550 °C.)

Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrogenated raffi-
nate-based; Base oil — unspecified

(A complex combination of hydrocarbons obtained by solvent deparaffi-
nation of the hydrogenated raffinate obtained by solvent extraction of a
hydrotreated petroleum distillate. It consists predominantly of hydrocar-
bons having carbon numbers predominantly in the range of C18 through
C40 and boiling in the range of approximately 370 °C to 550 °C.)

649-505-00-3

305-589-0

94733-09-2

L

649-506-00-9

305-594-8

94733-15-0

L

649-507-00-4

305-595-3

94733-16-1

L

Hydrocarbons, C13-30, arom.-rich, solvent-extd. naphthenic distillate; Base
oil — unspecified

649-508-00-X

305-971-7

95371-04-3

Hydrocarbons, C16-32, arom.-rich, solvent-extd. naphthenic distillate; Base
oil — unspecified

649-509-00-5

305-972-2

95371-05-4

Hydrocarbons, C37-68, dewaxed deasphalted hydrotreated vacuum distn.
residues; Base oil — unspecified

649-510-00-0

305-974-3

95371-07-6

Hydrocarbons, C37-65, hydrotreated deasphalted vacuum distn. residues;
Base oil — unspecified

649-511-00-6

305-975-9

95371-08-7

649-512-00-1

307-010-7

97488-73-8

L

L

L

L

L

Distillates (petroleum), hydrocracked solvent-refined light; Base oil —
unspecified

(A complex combination of hydrocarbons obtained by the solvent treat-
ment of a distillate from hydrocracked petroleum distillates. It consists
predominantly of hydrocarbons having carbon numbers predominantly in
the range of C18 through C27 and boiling in the range of approximately
370 °C to 450 °C.)

Distillates (petroleum), solvent-refined hydrogenated heavy; Base oil —
unspecified

(A complex combination of hydrocarbons obtained by the treatment of a
hydrogenated petroleum distillate with a solvent. It consists predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of C19 through C40 and boiling in the range of approximately
390 °C to 550 °C.)

649-513-00-7

307-011-2

97488-74-9

L

Lubricating oils (petroleum) C18-27, hydrocracked solvent-dewaxed; Base
oil — unspecified

649-514-00-2

307-034-8

97488-95-4

L

C 276E/228

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Hydrocarbons, C17-30, hydrotreated solvent-deasphalted atm. distn. residue,
distn. lights; Base oil — unspecified

(A complex combination of hydrocarbons obtained as first runnings from
the vacuum distillation of effluents from the treatment of a solvent deas-
phalted short residue with hydrogen in the presence of a catalyst. It
consists predominantly of hydrocarbons having carbon numbers predo-
minantly in the range of C17 through C30 and boiling in the range of
approximately 300 °C to 400 °C. It produces a finished oil having a visc-
osity of 4 10-6 m2·s-1 at approximately 100 °C.)

649-515-00-8

307-661-7

97675-87-1

L

Hydrocarbons, C17-40, hydrotreated solvent-deasphalted distn.
vacuum distn. lights; Base oil — unspecified

residue,

649-516-00-3

307-755-8

97722-06-0

L

(A complex combination of hydrocarbons obtained as first runnings from
the vacuum distillation of effluents from the catalytic hydrotreatment of a
solvent deasphalted short residue having a viscosity of 8 10-6 m2·s-1 at
approximately 100 °C. It consists predominantly of hydrocarbons having
carbon numbers predominantly in the range of C17 through C40 and
boiling in the range of approximately 300 °C to 500 °C.)

Hydrocarbons, C13-27, solvent-extd. light naphthenic; Base oil — unspeci-
fied

(A complex combination of hydrocarbons obtained by extraction of the
aromatics from a light naphthenic distillate having a viscosity of 9,5 10-
6 m2·s-1 at 40 °C.
It consists predominantly of hydrocarbons having
carbon numbers predominantly in the range of C13 through C27 and
boiling in the range of approximately 240 °C to 400 °C.)

Hydrocarbons, C14-29, solvent-extd. light naphthenic; Base oil — unspeci-
fied

(A complex combination of hydrocarbons obtained by extraction of the
aromatics from a light naphthenic distillate having a viscosity of 16 10-
6 m2·s-1 at 40 °C.
It consists predominantly of hydrocarbons having
carbon numbers predominantly in the range of C14 through C29 and
boiling in the range of approximately 250 °C to 425 °C.)

649-517-00-9

307-758-4

97722-09-3

L

649-518-00-4

307-760-5

97722-10-6

L

Hydrocarbons, C27-42, dearomatised; Base oil — unspecified

649-519-00-X

308-131-8

97862-81-2

Hydrocarbons, C17-30, hydrotreated distillates, distn.
unspecified

lights; Base oil —

649-520-00-5

308-132-3

97862-82-3

Hydrocarbons, C27-45, naphthenic vacuum distn.; Base oil — unspecified

649-521-00-0

308-133-9

97862-83-4

Hydrocarbons, C27-45, dearomatised; Base oil — unspecified

649-522-00-6

308-287-7

97926-68-6

Hydrocarbons, C20-58, hydrotreated; Base oil — unspecified

649-523-00-1

308-289-8

97926-70-0

Hydrocarbons, C27-42, naphthenic; Base oil — unspecified

649-524-00-7

308-290-3

97926-71-1

L

L

L

L

L

L

14.11.2006

EN

Official Journal of the European Union

C 276E/229

Substances

Index number

EC number

CAS number

Notes

Residual oils (petroleum), carbon-treated solvent-dewaxed; Base oil —
unspecified

(A complex combination of hydrocarbons obtained by the treatment of
solvent-dewaxed petroleum residual oils with activated charcoal for the
removal of trace polar constituents and impurities.)

649-525-00-2

309-710-8

100684-37-5

L

Residual oils (petroleum), clay-treated solvent-dewaxed; Base oil — unspe-
cified

(A complex combination of hydrocarbons obtained by treatment of
solvent-dewaxed petroleum residual oils with bleaching earth for the
removal of trace polar constituents and impurities.)

649-526-00-8

309-711-3

100684-38-6

L

Lubricating oils (petroleum) C25, solvent-extd., deasphalted, dewaxed,
hydrogenated; base oil — unspecified

(A complex combination of hydrocarbons obtained by solvent extraction
and hydrogenation of vacuum distillation residues. It consists predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of greater than C25 and produces a finished oil with a viscosity in
the order of 32 10-6 m2·s-1 to 37 10-6 m2·s-1 at 100 °C.)

Lubricating oils (petroleum) C17-32, solvent-extd., dewaxed, hydrogenated;
Base oil — unspecified

(A complex combination of hydrocarbons obtained by solvent extraction
and hydrogenation of atmospheric distillation residues. It consists predo-
minantly of hydrocarbons having carbon numbers predominantly in the
range of C17 through C32 and produces a finished oil with a viscosity in
the order 17 10-6 m2·s-1 to 23 10-6 m2·s-1 at 40 °C.)

Lubricating oils (petroleum) C20-35, solvent-extd., dewaxed, hydrogenated;
Base oil — unspecified

(A complex combination of hydrocarbons obtained by solvent extraction
and hydrogenation of atmospheric distillation residues. It consists predo-
minantly of hydrocarbons having carbon numbers predominantly in the
range of C20 through C35 and produces a finished oil with a viscosity in
the order of 37 10-6 m2·s-1 to 44 10-6 m2·s-1 at 40 °C.)

Lubricating oils (petroleum) C24-50, solvent-extd., dewaxed, hydrogenated;
Base oil — unspecified

(A complex combination of hydrocarbons obtained by solvent extraction
and hydrogenation of atmospheric distillation residues. It consists predo-
minantly of hydrocarbons having carbon numbers predominantly in the
range of C24 through C50 and produces a finished oil with a viscosity in
the order of 16 10-6 m2·s-1 to 75 10-6 m2·s-1 at 40 °C.)

649-527-00-3

309-874-0

101316-69-2

L

649-528-00-9

309-875-6

101316-70-5

L

649-529-00-4

309-876-1

101316-71-6

L

649-530-00-X

309-877-7

101316-72-7

L

Extracts (petroleum), heavy naphthenic distillate solvent, arom. conc.;
Distillate aromatic extract (treated)

(An aromatic concentrate produced by adding water to heavy naphthenic
distillate solvent extract and extraction solvent.)

649-531-00-5

272-175-3

68783-00-6

L

C 276E/230

EN

Official Journal of the European Union

14.11.2006

Substances

Index number

EC number

CAS number

Notes

Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent;
Distillate aromatic extract (treated)

(A complex combination of hydrocarbons obtained as the extract from
the re-extraction of solvent-refined heavy paraffinic distillate. It consists of
saturated and aromatic hydrocarbons having carbon numbers predomi-
nantly in the range of C20 through C50.)

649-532-00-0

272-180-0

68783-04-0

L

Extracts
Distillate aromatic extract (treated)

(petroleum), heavy paraffinic distillates,

solvent-deasphalted;

649-533-00-6

272-342-0

68814-89-1

L

(A complex combination of hydrocarbons obtained as the extract from a
solvent extraction of heavy paraffinic distillate.)

Extracts (petroleum), heavy naphthenic distillate solvent, hydrotreated;
Distillate aromatic extract (treated)

(A complex combination of hydrocarbons obtained by treating a heavy
naphthenic distillate solvent extract with hydrogen in the presence of a
catalyst.
It consists predominantly of aromatic hydrocarbons having
carbon numbers predominantly in the range of C20 through C50 and
produces a finished oil of at least 19 10-6 m2·s-1 at 40 °C.)

Extracts (petroleum), heavy paraffinic distillate solvent, hydrotreated;
Distillate aromatic extract (treated)

(A complex combination of hydrocarbons produced by treating a heavy
paraffinic distillate solvent extract with hydrogen in the presence of a
catalyst.
It consists predominantly of hydrocarbons having carbon
numbers predominantly in the range of C21 through C33 and boiling in
the range of approximately 350 °C to 480 °C.)

Extracts (petroleum), light paraffinic distillate solvent, hydrotreated; Distil-
late aromatic extract (treated)

(A complex combination of hydrocarbons produced by treating a light
paraffinic distillate solvent extract with hydrogen in the presence of a
catalyst.
It consists predominantly of hydrocarbons having carbon
numbers predominantly in the range of C17 through C26 and boiling in
the range of approximately 280 °C to 400 °C.)

Extracts (petroleum), hydrotreated paraffinic light distillate solvent; Distil-
late aromatic extract (treated)

(A complex combination of hydrocarbons obtained as the extract from
solvent extraction of intermediate paraffinic top solvent distillate that is
treated with hydrogen in the presence of a catalyst. It consists predomi-
nantly of aromatic hydrocarbons having carbon numbers predominantly
in the range of C16 through C36.)

Extracts
phurised; Distillate aromatic extract (treated)

(petroleum),

light naphthenic distillate solvent, hydrodesul-

(A complex combination of hydrocarbons obtained by treating the
extract, obtained from a solvent extraction process, with hydrogen in the
presence of a catalyst under conditions primarily to remove sulphur
compounds. It consists predominantly of aromatic hydrocarbons having
carbon numbers predominantly in the range of C15 through C30. This
stream is likely to contain 5 wt. % or more of 4- to 6-membered
condensed ring aromatic hydrocarbons.)

649-534-00-1

292-631-5

90641-07-9

L

649-535-00-7

292-632-0

90641-08-0

L

649-536-00-2

292-633-6

90641-09-1

L

649-537-00-8

295-335-4

91995-73-2

L

649-538-00-3

295-338-0

91995-75-4

L

14.11.2006

EN

Official Journal of the European Union

C 276E/231

Substances

Index number

EC number

CAS number

Notes

Extracts (petroleum), light paraffinic distillate solvent, acid-treated; Distil-
late aromatic extract (treated)

(A complex combination of hydrocarbons obtained as a fraction of the
distillation of an extract from the solvent extraction of light paraffinic top
petroleum distillates that is subjected to a sulphuric acid refining.
It
consists predominantly of aromatic hydrocarbons having carbon numbers
predominantly in the range of C16 through C32.)

Extracts (petroleum), light paraffinic distillate solvent, hydrodesulphurised;
Distillate aromatic extract (treated)

(A complex combination of hydrocarbons obtained by solvent extraction
of a light paraffin distillate and treated with hydrogen to convert the
organic sulphur to hydrogen sulphide which is eliminated. It consists
predominantly of hydrocarbons having carbon numbers predominantly in
the range of C15 through C40 and produces a finished oil having a visc-
osity of greater than 10-5 m2·s-1 at 40 °C.)

Extracts (petroleum), light vacuum gas oil solvent, hydrotreated; Distillate
aromatic extract (treated)

(A complex combination of hydrocarbons obtained by solvent extraction
from light vacuum petroleum gas oils and treated with hydrogen in the
presence of a catalyst. It consists predominantly of aromatic hydrocarbons
having carbon numbers predominantly in the range of C13 through C30.)

Extracts (petroleum), heavy paraffinic distillate solvent, clay-treated; Distil-
late aromatic extract (treated)

(A complex combination of hydrocarbons resulting from treatment of a
petroleum fraction with natural or modified clay in either a contact or
percolation process to remove the trace amounts of polar compounds
and impurities present. It consists predominantly of aromatic hydrocar-
bons having carbon numbers predominantly in the range of C20 through
C50. This stream is likely to contain 5 wt. % or more 4-6 membered ring
aromatic hydrocarbons.)

Extracts (petroleum), heavy naphthenic distillate solvent, hydrodesul-
phurised; Distillate aromatic extract (treated)

(A complex combination of hydrocarbons obtained from a petroleum
stock by treating with hydrogen to convert organic sulphur to hydrogen
sulphide which is removed. It consists predominantly of aromatic hydro-
carbons having carbon numbers predominantly in the range of C15
through C50 and produces a finished oil with a viscosity of greater than
19 10-6 m2·s-1 at 40 °C.)

Extracts (petroleum), solvent-dewaxed heavy paraffinic distillate solvent,
hydrodesulphurised; Distillate aromatic extract (treated)

(A complex combination of hydrocarbons obtained from a solvent
dewaxed petroleum stock by treating with hydrogen to convert organic
sulphur to hydrogen sulphide which is removed. It consists predomi-
nantly of hydrocarbons having carbon numbers predominantly in the
range of C15 through C50 and produces a finished oil with a viscosity of
greater than 19 10-6 m2·s-1 at 40 °C.)

649-539-00-9

295-339-6

91995-76-5

L

649-540-00-4

295-340-1

91995-77-6

L

649-541-00-X

295-342-2

91995-79-8

L

649-542-00-5

296-437-1

92704-08-0

L

649-543-00-0

297-827-4

93763-10-1

L

649-544-00-6

297-829-5

93763-11-2

L

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Substances

Index number

EC number

CAS number

Notes

Extracts (petroleum),
Distillate aromatic extract (treated)

light paraffinic distillate solvent, carbon-treated;

(A complex combination of hydrocarbons obtained as a fraction from
distillation of an extract recovered by solvent extraction of light paraffinic
top petroleum distillate treated with activated charcoal to remove traces
It consists predominantly of
of polar constituents and impurities.
aromatic hydrocarbons having carbon numbers predominantly in the
range of C16 through C32.)

Extracts (petroleum), light paraffinic distillate solvent, clay-treated; Distil-
late aromatic extract (treated)

(A complex combination of hydrocarbons obtained as a fraction from
distillation of an extract recovered by solvent extraction of light paraffinic
top petroleum distillates treated with bleaching earth to remove traces of
polar constituents and impurities. It consists predominantly of aromatic
hydrocarbons having carbon numbers predominantly in the range of C16
through C32.)

Extracts (petroleum), light vacuum, gas oil solvent, carbon-treated; Distil-
late aromatic extract (treated)

(A complex combination of hydrocarbons obtained by solvent extraction
of light vacuum petroleum gas oil treated with activated charcoal for the
removal of trace polar constituents and impurities. It consists predomi-
nantly of aromatic hydrocarbons having carbon numbers predominantly
in the range of C13 through C30.)

Extracts (petroleum), light vacuum, gas oil solvent, clay-treated; Distillate
aromatic extract (treated)

(A complex combination of hydrocarbons obtained by solvent extraction
of
light vacuum petroleum gas oils treated with bleaching earth for
removal of trace polar constituents and impurities. It consists predomi-
nantly of aromatic hydrocarbons having carbon numbers predominantly
in the range of C13 through C30.)

649-545-00-1

309-672-2

100684-02-4

L

649-546-00-7

309-673-8

100684-03-5

L

649-547-00-2

309-674-3

100684-04-6

L

649-548-00-8

309-675-9

100684-05-7

L

Foots oil (petroleum); Foots oil

649-549-00-3

265-171-8

64742-67-2

L

(A complex combination of hydrocarbons obtained as the oil fraction
from a solvent deoiling or a wax sweating process. It consists predomi-
nantly of branched chain hydrocarbons having carbon numbers predomi-
nantly in the range of C20 through C50.)

Foots oil (petroleum), hydrotreated; Foots oil

649-550-00-9

295-394-6

92045-12-0

Refractory ceramic fibres; Special Purpose Fibres, with the exception of
those specified elsewhere in Annex I to Directive 67/548/EEC; [Man-
made vitreous (silicate) fibres with random orientation with alkaline oxide
and alkali earth oxide (Na2O + K2O + CaO + MgO + BaO) content less or
equal to 18 % by weight]

650-017-00-8

L

R

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Appendix 3

Point 29 — Mutagens: category 1

C 276E/234

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Appendix 4

Point 29 — Mutagens: category 2

Substances

Index number

EC number

CAS number

Notes

Hexamethylphosphoric triamide; hexamethylphosphoramide

015-106-00-2

211-653-8

680-31-9

Diethyl sulphate

Potassium dichromate

Ammonium dichromate

Sodium dichromate

016-027-00-6

200-589-6

64-67-5

024-002-00-6

231-906-6

7778-50-9

024-003-00-1

232-143-1

7789-09-5

024-004-00-7

234-190-3

10588-01-9

Sodium dichromate, dihydrate

024-004-01-4

234-190-3

7789-12-0

Chromyl dichloride; chromic oxychloride

024-005-00-2

239-056-8

14977-61-8

Potassium chromate

Sodium chromate

Cadmium fluoride

Cadmium chloride

024-006-00-8

232-140-5

7789-00-6

024-018-00-3

231-889-5

7775-11-3

E

048-006-00-2

232-222-0

7790-79-6

048-008-00-3

233-296-7

10108-64-2

Butane [containing ≥ 0,1 % Butadiene (203-450-8)] [1]
Isobutane [containing ≥ 0,1 % Butadiene (203-450-8)] [2]

601-004-01-8

203-448-7 [1]
20-857-2 [2]

106-97-8 [1]
75-28-5 [2]

C, S

1,3-Butadiene buta-1,3-diene

601-013-00-X

203-450-8

106-99-0

D

Benzo[a]pyrene; benzo[d,e,f]chrysene

1,2-Dibromo-3-chloropropane

Ethylene oxide; oxirane

601-032-00-3

200-028-5

602-021-00-6

202-479-3

603-023-00-X

200-849-9

Propylene oxide; 1,2-epoxypropane; Methyloxirane

603-055-00-4

200-879-2

50-32-8

96-12-8

75-21-8

75-56-9

E

2,2'-Bioxirane; 1,2:3,4-diepoxybutane

603-060-00-1

215-979-1

1464-53-5

Methyl acrylamidomethoxyacetate (containing ≥ 0,1 % acrylamide)

607-190-00-X

401-890-7

77402-03-0

Methyl acrylamidoglycolate (containing ≥ 0,1 % acrylamide)

607-210-00-7

403-230-3

77402-05-2

Ethyleneimine; aziridine

613-001-00-1

205-793-9

151-56-4

1,3,5,-Tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione; TGIC

615-021-00-6

219-514-3

2451-62-9

Acrylamide

616-003-00-0

201-173-7

79-06-1

1,3,5-tris-[(2S and 2R)-2,3-epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-
trione

616-091-00-0

423-400-0

59653-74-6

E

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Appendix 5

Point 30 — Toxic to reproduction: category 1

Substances

Index number

EC number

CAS number

Notes

Carbon monoxide

Lead hexafluorosilicate

006-001-00-2

211-128-3

630-08-0

009-014-00-1

247-278-1

25808-74-6

Lead compounds with the exception of those specified elsewhere in this
Annex

082-001-00-6

Lead alkyls

Lead azide

Lead chromate

Lead di(acetate)

Trilead bis(orthophosphate)

Lead acetate

Lead(II) methanesulphonate

C.I. Pigment Yellow 34;

082-002-00-1

082-003-00-7

236-542-1

13424-46-9

082-004-00-2

231-846-0

7758-97-6

082-005-00-8

206-104-4

301-04-2

082-006-00-3

231-205-5

7446-27-7

082-007-00-9

215-630-3

1335-32-6

082-008-00-4

401-750-5

17570-76-2

082-009-00-X

215-693-7

1344-37-2

(This substance is identified in the Colour Index by Colour Index Consti-
tution Number, C.I. 77603.)

C.I. Pigment Red 104;

082-010-00-5

235-759-9

12656-85-8

(This substance is identified in the Colour Index by Colour Index Consti-
tution Number, C.I. 77605.)

Lead hydrogen arsenate

1,2-Dibromo-3-chloropropane

2-bromopropane

082-011-00-0

232-064-2

7784-40-9

602-021-00-6

202-479-3

602-085-00-5

200-855-1

96-12-8

75-26-3

81-81-2

E

Warfarin; 4-hydroxy-3-(3-oxo-1-phenylbutyl)coumarin

607-056-00-0

201-377-6

Lead 2,4,6-trinitroresorcinoxide, lead styphnate

609-019-00-4

239-290-0

15245-44-0

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Appendix 6

Point 30 — Toxic to reproduction: category 2

Substances

Index number

EC number

CAS number

Notes

6-(2-Chloroethyl)-6(2-methoxyethoxy)-2,5,7,10-tetraoxa-6-silaundecane;
etacelasil

014-014-00-X

253-704-7

37894-46-5

Flusilazole
ylmethyl)-silane

(ISO);

bis(4-fluorophenyl)-(methyl)-(1H-1,2,4-triazol-1-

014-017-00-6

–

85509-19-9

A mixture of: 4-[[bis-(4-fluorophenyl)-methylsilyl]methyl]-4H-1,2,4-tria-
zole; 1-[[bis-(4-fluorophenyl)methyl-silyl]methyl]-1H-1,2,4-triazole

014-019-00-7

403-250-2

–

E

E

Nickel tetracarbonyl

Cadmium fluoride

Cadmium chloride

028-001-00-1

236-669-2

13463-39-3

048-006-00-2

232-222-0

7790-79-6

048-008-00-3

233-296-7

10108-64-2

Benzo[a]pyrene; benzo[d,e,f]chrysene

601-032-00-3

200-028-5

50-32-8

2-Methoxyethanol; ethylene glycol monomethyl ether; methylglycol

603-011-00-4

203-713-7

109-86-4

2-Ethoxyethanol; ethylene glycol monoethyl ether; ethylglycol

603-012-00-X

203-804-1

110-80-5

2,3-Epoxypropan-1-ol; glycidol

603-063-00-8

209-128-3

556-52-5

2-Methoxypropanol

Bis(2-methoxyethyl) ether

R-2,3-epoxy-1-propanol

603-106-00-0

216-455-5

1589-47-5

603-139-00-0

203-924-4

111-96-6

603-143-002

404-660-4

57044-25-4

E

4,4'-isobutylethylidenediphenol; 2,2-bis (4'-hydroxyphenyl)-4-methylpen-
tane

604-024-00-8

401-720-1

6807-17-6

2-Methoxyethyl acetate; ethylene glycol monomethyl ether acetate;
methylglycol acetate

607-036-00-1

203-772-9

110-49-6

2-Ethoxyethyl acetate; ethylene glycol monoethyl ether acetate; ethyl-
glycol acetate

607-037-00-7

203-839-2

111-15-9

2-Ethylhexyl 3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl methyl
acetate

thio

607-203-00-9

279-452-8

80387-97-9

Bis(2-Methoxyethyl) phthalate

607-228-00-5

204-212-6

117-82-8

2-Methoxypropyl acetate

607-251-00-0

274-724-2

70657-70-4

Fluazifop-butyl (ISO); butyl (RS)-2-[4-(5-trifluoromethyl-2-pyridyloxy)phe-
noxy]propionate

607-304-00-8

274-125-6

69806-50-4

Vinclozolin (ISO); N-3,5-Dichlorophenyl-5-methyl-5-vinyl-1,3-oxazoli-
dine-2,4-dione

607-307-00-4

256-599-6

50471-44-8

Methoxyacetic acid

607-312-00-1

210-894-6

625-45-6

E

Bis(2-ethylhexyl) phthalate; di-(2-ethylhexyl) phthalate; DEHP

607-317-00-9

204-211-0

117-81-7

Dibutyl phthalate; DBP

607-318-00-4

201-557-4

84-74-2

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Substances

Index number

EC number

CAS number

Notes

tetrahydrofurfuryl

(+/-)
propionate

(R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenyloxy]-

607-373-00-4

414-200-4

119738-06-6

E

Binapacryl (ISO); 2-sec-butyl-4,6-dinitrophenyl-3-methylcrotonate

609-024-00-1

207-612-9

485-31-4

Dinoseb; 6-sec-butyl-2,4-dinitrophenol

609-025-00-7

201-861-7

88-85-7

Salts and esters of dinoseb, with the exception of those specified else-
where in this Annex

609-026-00-2

Dinoterb; 2-tert-butyl-4,6-dinitrophenol

609-030-00-4

215-813-8

1420-07-1

Salts and esters of dinoterb

609-031-00-X

Nitrofen (ISO); 2,4 dichlorophenyl 4-nitrophenyl ether

609-040-00-9

217-406-0

1836-75-5

Methyl-ONN-azoxymethyl acetate; methyl azoxy methyl acetate

611-004-00-2

209-765-7

592-62-1

Tridemorph (ISO); 2,6-dimethyl-4-tridecylmorpholine

613-020-00-5

246-347-3

24602-86-6

Ethylene thiourea; imidazolidine-2-thione; 2-imidazoline-2-thiol

613-039-00-9

202-506-9

Cycloheximide

613-140-00-8

200-636-0

96-45-7

66-81-9

Flumioxazin (ISO); N-(7-Fluoro-3,4-dihydro-3-oxo-4-prop-2-ynyl-2H-1,4-
benzoxazin-6-yl)cyclohex-1-ene-1,2-dicarboxamide

613-166-00-X

–

103361-09-7

(2RS,3RS)-3-(2-Chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)-
methyl]oxirane

613-175-00-9

406-850-2

106325-08-0

N,N-dimethylformamide; dimethyl formamide

616-001-00-X

200-679-5

68-12-2

N, N-Dimethylacetamide

Formamide

N-methylacetamide

N-methylformamide

616-011-00-4

204-826-4

127-19-5

616-052-00-8

200-842-0

616-053-00-3

201-182-6

75-12-7

79-16-3

616-056-00-X

204-624-6

123-39-7

E

E

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Appendix 7

Special provisions on the labelling of articles containing asbestos

1. All articles containing asbestos or the packaging thereof must bear the label defined as follows:

(a) the label conforming to the specimen below shall be at least 5 cm high (H) and 2,5 cm wide;

(b) it shall consist of two parts:

— the top part (h1 = 40 % H) shall include the letter ‘a’ in white, on a black background,

— the bottom part (h2= 60 % H) shall include the standard wording in white and/or black, on a red background,

and shall be clearly legible;

(c) if the article contains crocidolite, the words ‘contains asbestos’ used in the standard wording shall be replaced by

‘contains crocidolite/blue asbestos’.

Member States may exclude from the provision of the first subparagraph articles intended to be placed on the
market in their territory. The labelling of these articles must however bear the wording ‘contains asbestos’;

(d) if labelling takes the form of direct printing on the articles, a single colour contrasting with the background

colour is sufficient.

2. The label mentioned in this Appendix shall be affixed in accordance with the following rules:

(a) on each of the smallest units supplied;

(b) if an article has asbestos-based components, it is sufficient for these components only to bear the label. The label-
ling may be dispensed with if smallness of size or unsuitability of packaging make it impossible for a label to be
affixed to the component.

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3.

Labelling of packaged articles containing asbestos

3.1. The following particulars shall appear on clearly legible and indelible labelling on the packaging of packaged

articles containing asbestos:

(a) the symbol and relevant indications of danger in accordance with this Annex;

(b) safety instructions which must be selected in accordance with the particulars in this Annex, inasmuch as

they are relevant for the particular article.

Where additional safety information is provided on the packaging, this shall not weaken or contradict the
particulars given in accordance with points (a) and (b).

3.2. Labelling in accordance with 3.1 shall be effected by means of:

— a label firmly affixed to the packaging, or

— a (tie-on) label securely attached to the package, or

— direct printing of the packaging.

3.3. Articles containing asbestos and which are packaged only in loose plastic wrapping or the like shall be
regarded as packaged articles and shall be labelled in accordance with 3.2. If articles are separated from such
packages and placed on the market unpackaged, each of the smallest units supplied shall be accompanied by
labelling particulars in accordance with 3.1.

4. Labelling of unpackaged articles containing asbestos

For unpackaged articles containing asbestos, labelling in accordance with 3.1 shall be effected by means of:

— a label firmly affixed to the article containing asbestos,

— a (tie-on) label securely attached to such an article,

— direct printing on the articles,

or, if the abovementioned is not reasonably practicable as in the case of, for example, smallness of size of the article,
the unsuitable nature of the article's properties or certain technical difficulties by means of a hand-out with labelling
in accordance with 3.1.

5. Without prejudice to Community provisions on safety and hygiene at work, the label affixed to the article which
may, in the context of its use, be processed or finished, shall be accompanied by any safety instructions which may
be appropriate for the article concerned, and in particular by the following:

— operate if possible out of doors or in a well-ventilated place,

— preferably use hand tools or low-speed tools equipped, if necessary, with an appropriate dust-extraction facility. If

high-speed tools are used, they should always be equipped with such a facility,

— if possible, dampen before cutting or drilling,

— dampen dust and place it in a properly closed receptacle and dispose of it safely.

6. The labelling of any article intended for domestic use which is not covered by section 5 and which is likely, during

use, to release asbestos fibres shall, if necessary, contain the following safety instruction: ‘replace when worn’.

7. The labelling of articles containing asbestos shall be in the official language or languages of the Member State(s)

where the article is placed on the market.

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Appendix 8

Point 43 — Azocolourants

List of aromatic amines

1

2

3

4

5

6

7

8

9

CAS number

Index number

EC number

Substances

92-67-1

612-072-00-6

202-177-1

biphenyl-4-ylamine

92-87-5

95-69-2

91-59-8

97-56-3

99-55-8

106-47-8

615-05-4

101-77-9

4-aminobiphenyl

xenylamine

612-042-00-2

202-199-1

benzidine

202-441-6

4-chloro-o-toluidine

612-022-00-3

202-080-4

2-naphthylamine

611-006-00-3

202-591-2

o-aminoazotoluene

4-amino-2',3-dimethylazobenzene

4-o-tolylazo-o-toluidine

202-765-8

5-nitro-o-toluidine

612-137-00-9

203-401-0

4-chloroaniline

210-406-1

4-methoxy-m-phenylenediamine

612-051-00-1

202-974-4

4,4'-methylenedianiline

4,4'-diaminodiphenylmethane

10

91-94-1

612-068-00-4

202-109-0

3,3'-dichlorobenzidine

3,3'-dichlorobiphenyl-4,4'-ylenediamine

11

119-90-4

612-036-00-X

204-355-4

3,3'-dimethoxybenzidine

o-dianisidine

12

119-93-7

612-041-00-7

204-358-0

3,3'-dimethylbenzidine

13

14

838-88-0

120-71-8

612-085-00-7

212-658-8

4,4'-methylenedi-o-toluidine

4,4'-bi-o-toluidine

204-419-1

6-methoxy-m-toluidine

p-cresidine

15

101-14-4

612-078-00-9

202-918-9

4,4'-methylene-bis-(2-chloro-aniline)

2,2'-dichloro-4,4'-methylene-dianiline

16

17

18

19

20

21

101-80-4

139-65-1

95-53-4

95-80-7

137-17-7

90-04-0

202-977-0

4,4'-oxydianiline

205-370-9

4,4'-thiodianiline

612-091-00-X

202-429-0

o-toluidine

2-aminotoluene

612-099-00-3

202-453-1

4-methyl-m-phenylenediamine

205-282-0

2,4,5-trimethylaniline

612-035-00-4

201-963-1

o-anisidine

2-methoxyaniline

22

60-09-3

611-008-00-4

200-453-6

4-amino azobenzene

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Appendix 9

Point 43 — Azocolourants

List of azodyes

CAS number

Index number

EC number

Substances

1

Not allocated

611-070-00-2

405-665-4

Component 1:

CAS-No: 118685-33-9

C39H23ClCrN7O12S.2Na
Component 2:

C46H30CrN10O20S2.3Na

A mixture of: disodium (6-(4-anisidino)-3-sulfonato-2-(3,5-
dinitro-2-oxidophenylazo)-1-naphtholato)(1-(5-chloro-2-oxido-
phenylazo)-2-naphtholato)chromate(1-);

trisodium bis(6-(4-anisidino)-3-sulfonato-2-(3,5-dinitro-2-oxi-
dophenylazo)-1-naphtholato)chromate(1-)

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STATEMENT OF THE COUNCIL'S REASONS

I.

INTRODUCTION

1. On 5 November 2003, the Commission submitted a proposal for a Regulation concerning the
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and a proposal for a
Directive of the European Parliament and of the Council amending Council Directive 67/548/EEC
in order to adapt it to the REACH Regulation. The proposal is based on Article 95 of the EC Treaty.

2. The Economic and Social Committee delivered its Opinion on 31 March 2004 (1).

3. The European Parliament delivered its Opinion at first reading on 17 November 2005.

4. On 13 December 2005, the Council reached a Political agreement by unanimity on a compromise

text with a view to adopting its Common Position.

5. The Council adopted its common position in accordance with Article 251 of the EC Treaty on 27

June 2006

II. OBJECTIVES

Against the background of the considerable gap in knowledge of chemical substances, which has been
seen as a major weakness of the current EU chemicals policy, the proposal on ‘REACH’ seeks to
balance protection of human health and the environment with the impact on competitiveness, particu-
larly that of SMEs, as well as simplifying the administrative processes and making efficient use of
scarce resources.

More specifically, some of the main objectives of the new system are:

— To establish a coherent registration system designed to provide basic hazard and risk information

on new and existing substances manufactured in or imported into the EU;

— To reverse the burden of proof, moving it away from Member States' authorities to producing and
importing companies, who will be responsible for demonstrating that substances can be used
safely;

— To introduce responsibility for downstream users to provide information on uses and associated

risk management measures relating to substances;

— To maintain the existing restriction system and to introduce an authorisation procedure for the

most hazardous substances as a new instrument;

— To ensure greater transparency and openness for the public by providing easier access to relevant

information on chemicals;

— To establish a central entity to facilitate the administration of REACH and ensure that the system is

applied in a harmonised way across the EU.

III. COMMON POSITION

Taking into account the above objectives and the complex structure of the chemicals industry and its
supply chain, the Council has agreed on a text which seeks to ensure a high level of protection of
human health and the environment whilst limiting the administrative burdens and costs for European
industry in order to maintain its competitiveness and innovative capacity.

The text of the proposal was revised extensively during discussions carried out by the Council over the
last two years. During this process, the Presidencies of the Council had frequent contacts with the
European Parliament, which resulted in a substantial convergence of views between the two Institu-
tions. Thus around 200 amendments from the European Parliament's Opinion at first reading have
been reflected either in full, in part or in principle in the Common Position.

All modifications to the original proposal
Commission.

introduced by the Council have been accepted by the

(1) OJ C 112, 30.4.2004, p. 92

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Recitals

In general, 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, the Common Position takes on board the spirit of certain amendments:

Concerning amendment 11 (partly linked to amendments 59 and 364 on Article 1(2)) that introduces
a ‘duty of care’ for manufacturers, importers and downstream users to use or place substances on the
market in such a way that they do not damage human health or the environment, the Council
considers that the provisions of Article 1, as amended to state that chemical substances shall not
adversely affect human health or the environment, are sufficient.

As regards amendments 3, 416 and 419, which refer to the competitiveness and innovation capacity
of the European Chemicals industry as well as the compatibility of the REACH Regulation with WTO
requirements, the Council considers that REACH is in line with all WTO obligations and in itself
should stimulate innovation and thereby maintain or enhance competitiveness. Again, the Council
considers that the provisions of Article 1, as amended to state that one of the purposes of the Regu-
lation is to ensure the free circulation of goods while enhancing competitiveness and innovation, are
sufficient.

In general, several amendments included in the Common Position cover the spirit of amendments 22
and 363, which put the emphasis on the need to pay special attention to Small and Medium-sized
Enterprises (SMEs). In addition, the Council considers it necessary to introduce a new recital 8, under-
lining the need to take special account of the potential impact of REACH on SMEs and the need to
avoid any discrimination against them.

Other amendments to recitals have not been reflected since they would not be compatible with the
approach taken by the Council in its Common Position (amendments 2, 5, 6, 7, 9, 12, 13, 15, 17, 23,
24, 25, 27, 28, 30, 31, 32, 33, 34, 35, 37, 38, 42, 43, 44, 45, 46, 47, 52, 54, 55, 56, 57, 58, 90,
361and 424).

Title I — Scope and definitions

In its Common Position, the Council has consolidated and clarified the scope of the Regulation as well
as clarifying 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 cellu-
lose 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. Definitions in Article 3 have been adjusted to take account of the approach taken by
the Council in its Common Position.

On this basis, the Common Position reflects either in full, in principle or in part the European Parlia-
ment's amendments 65, 68, 69, 74, 79, 372, 376, 377, 462rev, 463rev, 464rev, 465rev, 466rev,
469rev and 983..

As regards amendment 67 concerning alloys and their definition as special preparations, the Council
welcomes the Commission's intention, expressed in a new recital, to develop guidance, in close coop-
eration with Member States and stakeholders, on the assessment of special preparations.

Amendments, which are not in line with the Council's approach, are not reflected in the Common
Position (amendments 59 and 364 (see above under ‘Recitals’), 60, 66, 70, 71, 75, 76, 77, 78, 80, 82,
673 and 676).

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Title II — Registration

With a view to including the main elements of the ‘one substance — one registration’ (OSOR) proposal
introduced during the Council's examination, 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 possibi-
lities 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 by an assessor chosen by
the registrant as having appropriate experience would be a possibility on a voluntary basis.

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.

The above criteria are established in Annex III. These aim to be clear, simple for industry to apply
and related to the information known about a substance's properties, uses and likely exposure.

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, biode-
gradation 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
1 000 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.

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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.

Overall, the Council has aimed at designing a workable and less burdensome system of registration
while ensuring that enough information is generated by industry to allow a substance to be used safely
and information to be made available to the authorities and downstream users.

In line with the above considerations, the Common Position reflects completely, in principle or in part
the following amendments: 88, 89, 97, 99, 104, 108, 109, 112, 116, 117, 118, 119, 373, 380, 381,
382, 386, 387 and 436.

The Common Position does not take on board some amendments which would not be in line with the
approach outlined above (Amendments 90, 96, 105, 106, 110, 113, 114, 121, 374, 375, 422,
469rev, 433, 549, 575rev, 584, 593, 594, 595, 596, 611 and 960).

More specifically, concerning amendments 96, 106, 108 and 549, 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.

Other amendments, such as amendments 593, 594, 595 and 596 have not been taken on board
simply because it would not be appropriate to introduce provisions on company groups in this Regu-
lation.

Finally, 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), amendment 110 has not
been taken on board, which would introduce a requirement to make a Chemical Safety Assessment for
all substances subject to registration.

Title III — Data-sharing and avoidance of unnecessary testing

The Common Position 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 unam-
biguous 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 intro-
duced.

The fact that 30 of the amendments adopted by the European Parliament at first reading have been
reflected in the Common Position either in full, in principle or in part (amendments 27, 123, 125,
126, 128, 130, 131, 132, 134, 136, 137, 138, 142, 143, 147, 148, 149, 151, 153, 154, 358, 367,
369rev, 370, 371, 379 and 384) shows that the European Parliament and the Council share the same
objectives, particularly in relation to reducing testing on vertebrate animals and facilitating data
sharing.

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The Common Position does not incorporate amendment 383, 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.

The Common Position does not take on board two amendments stipulating that sharing of costs
should be proportionate to the production volume (amendments 150 and 155).

Other amendments have not been reflected since they would not be in line with the approach taken by
the Council (amendments 129, 135, 139, 140, 150, 152, 155, 156, 368, 383 and 385).

Title IV — Information in the supply chain

The Council has included in its Common Position 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.

Based on this approach, most of the amendments adopted by the European Parliament at first reading
(amendments 157, 158, 159, 160, 161, 162, 163, 164, 165, 166, 366 and 710) are reflected in the
Common Position.

The Common Position does not include amendment 365, which provides that workers would be
granted access by producers to information given in the supply chain, since such a responsibility lies
with the employer. Amendment 168 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.

Title V — Downstream users

The Common Position clarifies the role of distributors and downstream users in the supply chain, espe-
cially as regards how manufacturers, importers or downstream users should react to information on
identified uses provided by distributors and/or downstream users. Similarly to amendment 719, the
Common Position also clarifies that downstream users can participate in a Substance Information
Forum (SIEF). Finally, the Common Position 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. Finally, the Council
has in its Common Position decided to delete Annex Ib (Chemical Safety Assessments for Preparations)
given that the scientific methodology underpinning this Annex is still being developed.

On this basis, the Common Position does not take on board certain amendments adopted by the Euro-
pean Parliament at first reading (amendments 169, 726). Concerning amendment 169, which would
introduce a lighter procedure for SMEs, the Council shares the view that the burden on this group of
companies should be alleviated. This is clearly expressed in recitals 8 (special account should be taken
of the potential impact of REACH on SMEs), recital 34 (guidance), Article 73 (reduced fees for SMEs)
and Article 76 (Agency assistance).

Title VI — Evaluation

In its Common Position, 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.

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— 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 authori-
ties can, if appropriate, use expert institutes to perform the evaluation.

On the basis of the approach adopted, the Common Position reflects in full, in principle or in part
amendments 171, 174, 175, 178, 179, 180, 181, 182, 183, 184, 185, 187, 188, 190, 191, 192, 193,
195, 196, 197, 199, 201, 205, 206, 207, 208, 209, 211, 213, 470rev, 729, 730, 733, 739, 744, 745
and 746.

The Common Position does not reflect the amendments which would give full responsibility for
substance evaluation to the Agency (amendments 170, 202, 203, 742 and 743) although the Common
Position has been moved significantly in this direction. As stated above, the Council considers that the
most workable solution is for the Agency to be responsible for co-ordinating the substance evaluation
process, relying on the Member States' competent authorities to perform the evaluations. In line with
this approach, the Council supports the European Parliament's view that the Agency should be given a
more prominent role in the whole evaluation process, e.g. through developing criteria for prioritising
substances and through the establishment of the Community rolling action plan of substances to be
evaluated.

As regards amendment 177, which concerns mandatory consultation of the European Centre for Vali-
dation of Alternative Methods (ECVAM) before deciding on animal testing and has not been acknowl-
edged directly in the Common Position. However, Article 13(2) stipules that test methods will be
revised as appropriate to refine, reduce or replace animal tests which goes in the same direction, since
ECVAM will play a role in this work.

Since this would not be in line with the approach taken the Common Position does not include
amendments 173, 176, 186, 189, 194, 198, 200, 204 and 212.

Title VII — Authorisation

Various amendments have been included in the Council's Common Position designed to strengthen
authorisation whilst ensuring that the provisions are workable.

The scope of authorisation as set out in Article 56 (a) to (e) of the Commission proposal has not been
amended. However, in line with amendment 217, the wording of Article 56(f) as been clarified.

For reasons of increased transparency and to facilitate planning within industry, a candidate list of
substances meeting the authorisation criteria of Article 56 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. This
is similar to the view taken by the European Parliament with the introduction of Annexes XIIIa and
XIIIb (amendment 215).

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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 environ-
ment arising from the use of the substance and where there are no suitable alternatives substances or
technologies available. It has been made clear that the ‘adequate control’ route to authorisations does
not apply to PBTs, vPvBs, or substances meeting the criteria in Article 54(a) — (c) and (f) for which it
is not possible to determine a threshold in accordance with Section 6.4 of Annex I. It has also been
made clear that the Commission shall review Annex I within twelve months after the entry into force
of the Regulation.

The existence of an authorisation procedure would in itself encourage substitution since less harmful
substances would not require an authorisation. In addition, in order to further encourage the develop-
ment of safer substitutes, all applications for authorisation will include an analysis of available alterna-
tives 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 moni-
toring 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.

In line with this approach, the Common Position incorporates in full, in principle or in part amend-
ments 215, 216, 217, 219, 223, 226, 227, 229, 235, 236, 237, 241, 242, 243, 245, 470rev, 471 and
568.

The Common Position does not take on board amendments 214 and 232, which would require
mandatory substitution if suitable alternatives are available. With a view to safeguarding the European
chemicals industry's competitiveness while at the same time protecting human health and the environ-
ment, the Council considers that the measures included in the Common Position provide for a solution
which is more balanced and workable.

In line with this philosophy, the Common Position does not reflect amendment 221 concerning the
five-year limitation on the review period for substances included in Annex XIV, or the part of amend-
ment 235 concerning the five-year time limit for authorisations granted.

In general, a number of amendments (218, 220, 222, 224, 225, 228, 230, 231, 232, 233, 234, 238,
239, 240, 244 and 246) have not been reflected in the Common Position since this would not be in
line with the approach taken by the Council.

Title VIII — Restrictions

The Council has included in its Common Position 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.

In line with this approach, the Common Position reflects in full, in principle or in part amendments
247, 569, 570, 571, 572, 789 and 985.

The amendments 248 and 251 are not reflected in the Common Position.

Title IX — 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.

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Title X — Agency

The Council's Common Position clarifies this Title on several points, including

— 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.

— With a view to avoiding any ambiguity in relation to Decision 2004/97/EC of 13 December 2003
in which it was decided that the seat of the Agency should be Helsinki, the Council has decided to
delete the reference to the seat of the Agency in the REACH Regulation (amendment 291).

— The Agency will get its funding from contributions from the Community budget, fees paid by

industry, and voluntary contributions from Member States.

In line with what has been outlined above, the Common Position reflects in full, in principle or in part
amendments 258, 259, 260, 261, 265, 266, 270, 285, 288, 291, 293, 294, 418, 796 and 801.

All the amendments stipulating that the Agency should have overall responsibility for the management
of REACH (in particular amendments 253, 256 and 795) or that part of the amendments putting
emphasis on the Agency as the main authority in the field of REACH (amendments 260, 261, 262,
263 and 796) have not been incorporated in the Common Position.

In the Common Position, the Agency has been given a more prominent role in the whole evaluation
process whilst clarifying that Member States should perform substance evaluations.

Furthermore, amendments 267, 269, 360 and 1037 have not been included since it would not be
appropriate to involve the European Parliament directly or indirectly in the appointment of members
of the Management Board.

In general the Common Position does not take on board the following amendments: 252, 253, 254,
256, 257, 264, 267, 269, 271, 272, 273, 275, 276, 277, 278, 279, 280, 281, 282, 283, 284, 286,
287, 288, 289, 290, 292, 295, 795 and 1037.

Title XI — Classification and labelling

The Council's 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 amendments 295, 296, 472rev and 473rev.

Title XII — Information

This Title has been modified substantially with a view to bringing its provisions in line with Regulation
(EC) No 1049/2001 (1) regarding public access to European Parliament, Council and Commission docu-
ments.

The Common Position provides that the detailed rules for access to information held by the Agency
(Article 117) should be drawn up by the Agency's Management Board in accordance with the provi-
sions of the Aarhus Convention and with Regulation (EC) No 1049/2001.

In line with the above, the Common Position reflects in principle amendment 297 stipulating that
Member States, the Agency and the Commission will submit a report every five years on experiences
gained.

(1) OJ L 145, 31.5.2001, p.43

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The Common Position also reflects in principle amendment 301 stipulating that the Agency will
publish non-confidential information on the website.

In order to bring the provisions on access to documents in line with Regulation (EC) No 1049/2001,
the principle of amendments 304, and 814 have been reflected. In line with this approach, it was not
considered appropriate to incorporate amendments 298, 300 and 808.

Title XIII — Competent Authorities

In line with the principle of amendment 305, 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 amendment 306 concerning special help and advice
to SMEs. The Council considers that Member States helpdesks will be of great benefit to industry, in
particular to SMEs.

Title XIV — Enforcement

Some clarification of the sanctions regime to be established by Member States has been introduced in
the Common Position.

The Common Position does not reflect amendments 307 and 816 giving the Forum within the Agency
the task to draw up guidelines on enforcement. However, in line with the Commission's proposal, the
Forum shall identify enforcement strategies as well as best practice in enforcement.

As in case of amendment 306, the Council considers that the principle of amendment 362 would be
covered by the Member States' helpdesk, which would be of great help to SMEs. This provision is also
underpinned by recital 8 stipulating that special attention should be given to SMEs.

The Common Position does not reflect amendments 817 and 818 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.

Title XV — Transitional and final provisions

The Common Position reflects in principle amendment 309 laying down that Member States have the
right to maintain more stringent measures on the protection of workers, human health and the envir-
onment, provided that the area is not harmonised by the REACH Regulation.

Regarding amendment 822 on the preparation of the establishment of the Agency, the Commission
and the Council have committed themselves in a joint statement to provide the necessary support
towards setting up of the Agency. The transitional period in relation to the setting-up of the Agency
(and subsequent amendments to the transitional period relating to existing legislation) has been
amended in line with the Commission's stated intention not to fulfil the functions of the Agency in the
period between the entry into force of the Regulation and the establishment of the Agency.

The Common Position takes on board the editorial modification suggested in amendment 317 in its
Common Position.

In line with the amendment 573 (and related amendments in other Titles), the Council also considers it
more appropriate not to regulate Persistent Organic Pollutants (POPs) within the framework of
REACH.

Since this would not be in line with the approach in the Common Position, amendments 311, 312,
313, 314, 315, 316, 318, 474 and 823 have not been incorporated

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Annexes

The following key changes to the Annexes have been introduced in the Common Position:

— 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 the entry into force of REACH.

— Categories of exemption from registration listed in Annex V have been amended, particularly
through the addition of natural substances such as ores, ore concentrates, minerals and cement
clinker.

— Criteria for targeting low volume phase-in substances (those manufactured or imported in quanti-
ties of 1 to 10 tonnes per manufacturer or importer per year) requiring the full Annex VII have
been established in Annex III. These aim to be clear, simple for industry to apply and related to the
information known about a substance's properties, uses and likely exposure.

— As Annex VII will only apply to a limited number of phase-in substances in the tonnage range of
1-10 tonnes/year, the Council has included additional information requirements in relation to acute
toxicity, biodegradation and algal toxicity.

— Only one test for reproductive toxicity is foreseen for Annex VIII (additional

information for
substances produced or imported in quantities of 10 tonnes or more per manufacturer or importer
per year).

— No significant changes in requirements are introduced for Annexes IX and X.

— In general, Annexes VI-XI include other technical revisions.

— 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.

— Annex X (test methods) of the Commission's proposal has been deleted and the test methods will

be included in a separate regulation to be adopted by the Commission

On this basis, the Common Position reflects in full, in principle or in part amendments 320, 388, 322,
323, 324, 327, 389, 390, 391, 392, 394, 395, 396, 397, 398, 399, 400, 402, 403, 404, 405, 406,
407, 408, 409, 410, 411, 412, 413, 475rev, 476rev, 477rev, 478rev, 660, 865 and 966.

The Common Position does not take on board the following amendments: 321, 328, 329, 337, 351,
393, 401, 574, 831, and 965.

Amendments to Council Directive 67/548/EEC — Dangerous substances

The Common Position introduces some additional technical amendments to Directive 67/548/EEC
resulting from the amendments made to the REACH Regulation in relation to the transitional period
for setting-up the Agency.

In line with the approach under Title XII (Information) of the REACH Regulation, the Council did not
consider it appropriate to incorporate amendments 1, 2 and 3.

IV. CONCLUSION

The Council considers that its Common Position, which is the result of extensive preparatory work and
negotiations since 2003 and which is fully supported by the Commission, is wholly in line with the
different objectives of REACH. Thus, the Common Position seeks to establish a workable and efficient
system, which represents a good balance between the protection of human health and the environment
and maintaining the competitiveness of EU industry.

As a result of frequent contacts and exchanges of views between the respective Presidencies of the
Council and the key players of the European Parliament, a significant convergence of positions
between the two Institutions emerged during the process. This convergence is well reflected in the
Common Position.